&EPA
United States
Environmental Protection
Agency
Enforcement and
Compliance Assurance
(2221-A)
EPA 305B-02-001
February 2002
Federal Insecticide,
Fungicide, and
Rodenticide Act
(FIFRA) Inspection
Manual
KEEP OUT
HERBICIDE
ApaiCATlON
U.S. Environmental Protection Agency
Office of Enforcement and Compliance Assurance
Office of Compliance
1200 Pennsylvania Avenue, NW
Washington DC, 20460
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FIFRA Inspection Manual, February 2002
FORWARD
The primary purpose of this Manual is to assist Federal inspectors who are involved in
pesticides enforcement. This Manual may also be helpful in orienting and training State,
Territorial, and Tribal inspectors and other Regional staff. This Manual provides the necessary
guidance, policies, authorities, and objectives for carrying out standard field procedures.
However, it does not (and obviously is not intended to) cover every possible situation that may
be encountered. This Manual is simply a reference to aid in more efficient and effective
pesticide inspections.
The mission of the Regional FIFRA field staff is to assist EPA in the protection of human health
and the environment from unsafe and ineffective pesticides by enforcing the pesticide laws. A
rigorous and fairly administered enforcement program will guarantee the success of this
mission. Such an enforcement program is dependent on well-trained, qualified field personnel
who both (1) conduct inspections and investigations that discover violations of the laws and
regulations; and (2) collect the evidence necessary to prosecute violators successfully.
In order to help us update the Manual so that it remains a viable working tool, readers are
encouraged to offer suggestions, amendments, and constructive criticism generated by their
field experience and use of the Manual. Comments should be forwarded to Mickey Post at EPA
Headquarters (post.mickey@epa.gov or 202-564-4157).
This Manual was compiled by a work group of representatives from Headquarters, the Regions,
States, and Tribes. Assistance, comments, and suggestions were provided by all Regions,
Headquarters, States, and Tribes. The work group held several conference calls to discuss,
revise, and finalize the Manual. The work group included the following individuals:
OECA/OFFICE OF COMPLIANCE
• John J. Neylan
• Mickey Post
• Amar G. Singh
REGIONAL REPRESENTATIVES
• Adrian Enache, Region II
• John Smith, Region III
• Carlton Layne, Region IV
• David Star, Region V
• Dea Zimmerman, Region V
• Terry Brance, Region V
• Greg Weiler, Region VI
• Britta Campbell, Region VII
• David Ramsey, Region VII
• David Wilcox, Region VII
• Mike Rudy, Region VIII
• Steve Arbaugh, Region IX
OFFICE OF REGULATORY ENFORCEMENT
• Brian Dyer
OFFICE OF GENERAL COUNSEL
• Phil Ross
STATE LEAD PESTICIDE AGENCY
REPRESENTATIVES
• Jerry Kirbach, IL, Dept. of Agriculture
• Tim Creger, NE, Dept. of Agriculture
• Dave Frederickson, WI, Dept. of Agriculture
Forward
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FIFRA Inspection Manual, February 2002
DISCLAIMERS
This Manual has been reviewed by the Office of Compliance, U.S. Environmental Protection
Agency, and approved for publication. This guidance represents EPA's recommended
procedures for conducting FIFRA compliance inspections. Deviations from this guidance on
the part of any duly authorized official, inspector, or agent to follow its contents shall not be a
defense in any enforcement action; nor shall deviation from this guidance constitute grounds
for rendering the evidence obtained thereby inadmissible in a court of law. The mention of
trade names or commercial products constitutes neither endorsement nor recommendation for
use.
Disclaimer
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FIFRA Inspection Manual, February 2002
TABLE OF CONTENTS
Chapter One: Administration
INTRODUCTION 1-1
STANDARDS OF PROFESSIONAL CONDUCT 1-2
PROFESSIONAL ATTITUDE 1-2
ATTIRE 1-3
INDUSTRY, PUBLIC, AND CONSUMER RELATIONS 1-3
GIFTS, FAVORS, AND LUNCHEONS 1-3
RECORDKEEPING 1-3
Time 1-3
Travel 1-4
KNOWLEDGE REQUIRED OF AN INSPECTOR 1-4
DOCUMENTARY SUPPORT 1-7
Field Notebooks 1-7
Inspection Entries 1-7
Statements 1-8
Photographs 1-9
Drawings and Maps 1-10
Printed Matter 1-10
Mechanical Recordings 1-10
DISCLOSURE OF OFFICIAL INFORMATION 1-10
Requests for Information by the Trade or Public 1-10
Confidential Information 1-11
Procedures for FIFRA CBI Acquired During An Inspection 1-12
Obtaining CBI by an Authorized Inspector 1-12
Obtaining CBI by an Unauthorized Inspector Through
Voluntary Access 1-12
Exhibit 1-1: List of EPA Federal Forms Used for FIFRA 1-14
Chapter Two: Pesticides Law and Definitions
STATUTORY AUTHORITY FOR PESTICIDE REGULATION 2-1
FIFRA 2-2
REGULATIONS, POLICIES, AND COMPLIANCE STRATEGIES 2-2
DEFINITIONS 2-3
KEY COMPLIANCE TERMS AND REQUIREMENTS 2-16
Chapter Three: Registration
PESTICIDE REGISTRATION 3-1
Amendments of 1996 3-1
Amendments of 1988 3-1
Background on FIFRA 3-1
REGISTRATION PROCEDURES 3-5
New Registration (40 CFR 152.42) 3-6
Amended Registration (40 CFR 152.44) 3-6
Supplemental Distribution (40 CFR 152.132) 3-6
Section 24(c) Registrations (40 CFR 162.150 - 162.156) 3-7
Exhibit 3-1: Application for Registration 3-8
Exhibit 3-2: Application for Supplemental Registration of Distributor 3-9
Table of Contents • i
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FIFRA Inspection Manual, February 2002
Chapter Four: Federal/State Cooperation
AUTHORITY 4-1
Cooperative Enforcement Agreements 4-1
State Primacy 4-1
Referral Procedures under FIFRA Sections 26 and 27 4-2
Inspectional Authority 4-3
Inspections When the State Has Use Primacy 4-3
Nonprimacy Inspections 4-3
BACKGROUND 4-3
RESPONSIBILITY 4-4
Environmental Protection Agency 4-4
States 4-4
Exhibit 4-1: FIFRA Enforcement Policy 4-5
Chapter Five: Experimental-Use Permit Inspection
AUTHORITY 5-1
Unlawful Acts 5-1
OBJECTIVES 5-1
RESPONSIBILITY 5-2
The Office of Pesticide Programs (OPP), EPA 5-2
EPA Regional Offices 5-2
CONDUCTING THE EUP INSPECTION 5-3
Adverse Effects 5-4
REPORTING 5-4
Chapter Six: Cancellation and Suspensio
AUTHORITY 6-1
Cancellation 6-1
Suspension 6-1
Unlawful Acts 6-2
OBJECTIVE 6-2
POLICY 6-2
GENERAL 6-2
PROCEDURES 6-3
Producer Establishment Inspections 6-3
Marketplace Inspections 6-3
Use Inspections 6-4
Storage and Disposal of Suspended or Canceled Pesticides 6-4
Indemnity Payments 6-4
Chapter Seven: Pesticide Producing Establishment Inspection
STATUTORY AUTHORITIES 7-1
Important Definitions 7-1
INSPECTION POLICIES 7-2
INSPECTION OBJECTIVES 7-4
INSPECTION PROCEDURES 7-5
Inspection Preparation 7-5
Entry and Opening Conference 7-7
Observations and Evidence Collection 7-7
Scope of the Establishment Inspection 7-7
Official Sampling 7-8
Table of Contents • ii
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FIFRA Inspection Manual, February 2002
Inspecting Books and Records 7-8
Conducting Label Reviews 7-9
Receipt for Samples and Closing Conference 7-10
PREPARING THE INSPECTION REPORT 7-12
Establishment Inspection Report 7-12
PESTICIDE-PRODUCING ESTABLISHMENTS 7-12
Authority 7-12
Domestic Establishments 7-12
Foreign Establishments 7-13
ESTABLISHMENT REGISTRATION NUMBERS 7-13
Placement on Label or Containers 7-13
PESTICIDE PRODUCTION REPORTS 7-14
Who Must Report 7-14
When to Report 7-14
Confidentiality 7-15
Child Resistant Packaging Requirements and Recordkeeping
Requirements 7-15
MARKETPLACE INSPECTIONS 7-16
Objectives 7-17
Inspector's Obligations and Procedures 7-17
When to Conduct Marketplace Inspections 7-18
Places to Inspect 7-18
Marketplace Inspections 7-19
Potential Inspection Sites 7-19
Entry 7-19
Persons Interviewed 7-19
Description of Activity 7-19
Label/Labeling Review 7-19
Pesticide Product Review 7-20
Shipping Records 7-20
Bulk Repackager Inspections 7-20
Objectives 7-20
Bulk Facilities Inspections 7-20
Inspector's Obligations and Procedures 7-20
PREPARING THE INSPECTION REPORTS 7-21
Establishment Inspection Report 7-21
Marketplace Inspection Report 7-22
Exhibit 7-1: Notice of Inspection (EPA Form 3540-2) 7-23
Exhibit 7-2: Producer Establishment Inspection Checklist 7-25
Exhibit 7-3: Marketplace Inspection Checklist 7-28
Exhibit 7-4: Receipt for Samples (EPA Form 3540-3) 7-30
Exhibit 7-5: Report on Establishment Inspection to Determine
Compliance with FIFRA 7-32
Exhibit 7-6: Application for Registration of Pesticide-Producing
Establishments (EPA Form 3540-8) 7-36
Exhibit 7-7: Instructions for Completing EPA Form 3540-8 7-37
Exhibit 7-8: Pesticides Report for Pesticide-Producing Establishments
(EPA Form 3540-16) 7-44
Exhibit 7-9: Instructions for Completing EPA Form 3540-16 7-45
Exhibit 7-10: Conducting the Labeling Review 7-52
Chapter Eight: Interagency Pesticide Referral
AUTHORITY 8-1
Table of Contents • Mi
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FIFRA Inspection Manual, February 2002
OBJECTIVE 8-1
POLICY 8-1
PROCEDURES 8-2
Referrals from EPA to FDA and USDA 8-2
Referrals from EPA to State Agencies 8-3
Exhibit 8-1: Interagency Referral Form 8-4
Chapter Nine: FIFRA Pesticide Product Samplin
AUTHORITY 9-1
OBJECTIVES 9-1
POLICY 9-2
SAMPLE COLLECTION 9-2
Sources of Pesticide Samples 9-2
Marketplace Inspections 9-3
Potential Inspection Sites 9-3
Entry 9-3
Persons Interviewed 9-3
Description of Activity 9-3
Label/Labeling Review 9-3
Pesticide Product Review 9-4
Shipping Records 9-4
Sampling 9-4
Narrative 9-4
Types of Samples 9-4
Sample Procedures 9-6
Small Sized Units 9-6
Larger Sized Units 9-7
Dry Material 9-7
Liquid Material 9-8
Labels 9-8
After Sampling 9-9
Restoring Lot to Order 9-9
Preparing Duplicate Samples 9-9
Preparing the Receipt for Samples 9-9
Payment for Samples 9-10
SAMPLE DOCUMENTATION 9-10
Responsibility 9-10
Records Showing Shipment 9-10
Invoices 9-11
Bill of Lading 9-11
Freight Bill 9-11
Waybill 9-12
Mail or Parcel Service Shipments 9-12
Shipments by Noncommercial Vehicle 9-12
Statements and Dealer's Statements 9-13
Statements 9-14
Refusal to Sign 9-14
Investigation Summary Report 9-14
Memorandum to Accompany Investigation Summary Report 9-14
SAMPLE PREPARATION, CUSTODY, AND HANDLING 9-15
Identification of Samples and Labels 9-15
Identification of Documents 9-15
Records 9-15
Table of Contents • iv
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FIFRA Inspection Manual, February 2002
Accompanying Literature, Labeling, Photographs, and Exhibits 9-15
Physical Sample Custody 9-16
Preparing the EPA Official Sample Seal 9-16
Applying the EPA Official Sample Seal 9-16
Sample Integrity and Sample Custody 9-16
Mode of Transfer 9-17
Hand Delivery 9-17
Common Carrier 9-17
U.S. Postal Service 9-18
Exhibit 9-1: Receipt for Samples (EPA Form 3540-3) 9-19
Exhibit 9-2: Copy of Invoice and Shipping Record (EPA Form
3540-13) 9-21
Exhibit 9-3: Dealer's Statement (EPA Form 3540-19) 9-22
Exhibit 9-4: Statement (EPA Form 3540-42) 9-23
Exhibit 9-5: EPA Official Sample Seal (EPA Form 7500-2) 9-24
Exhibit 9-6: Chain of Custody Record (EPA Form 3540-41) 9-25
Exhibit 9-7: Hazardous Materials Definition 9-26
Exhibit 9-8: Guide for Shippers 9-31
Exhibit 9-9: Guide for Hazardous Materials Shipping Papers 9-34
Exhibit 9-10: Mailability of Hazardous Materials 9-37
Chapter Ten: Stop Sale, Use, or Removal Order
AUTHORITY 10-1
Stop Sale, Use or Removal Orders 10-1
Seizures 10-1
Unlawful Act 10-1
OBJECTIVE 10-1
POLICY 10-1
Special Considerations 10-2
Process 10-2
PROCEDURES 10-3
Service of Order by United States Mail 10-3
Regional Office 10-3
Headquarters 10-3
Service of Order by Inspector 10-3
Refusal to Accept Order 10-3
No One Available to Accept Order 10-4
Disposition 10-4
Violations of Orders 10-4
Follow-up Inspections 10-4
Chapter Eleven: Recalls
AUTHORITY 11-1
Statutory/Regulatory Requirements 11-1
Voluntary Recall [Section 19(b)(2)] 11-1
Mandatory Recall [Section 19(b)(3)] 11-1
Recall Procedure 11-1
Contents of Recall Plan [Section 19(b)(5)] 11-2
Special Considerations 11-2
OBJECTIVES 11-2
PROCEDURES 11-3
Process 11-3
Recalls 11-3
Table of Contents • v
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FIFRA Inspection Manual, February 2002
Levels of Recalls 11-3
Notification to the Company 11-4
Inspection Procedures 11-4
Initial Visit to Company 11-4
Follow-Up to Recall 11-4
Follow-up After Completion of Recall 11-5
Reporting 11-5
Initial Recall Report 11-5
Interim Reports 11-5
Final Recall Reports 11-5
Follow-Up Reports at Consignees 11-6
Chapter Twelve: Use Inspections and Followup Enforcemen
AUTHORITY 12-1
Introduction 12-1
Statutory Basis 12-1
Consent 12-2
Open Fields 12-2
Exigent Circumstances 12-3
Plain View 12-3
OBJECTIVES 12-3
POLICY 12-4
USE INSPECTIONS 12-4
Inspector Obligations and Procedures 12-5
Use Inspection Procedures 12-5
Persons Interviewed 12-5
Description of Facility 12-6
Pesticide(s) Inspected 12-6
Records Review 12-7
Storage Facility Conditions 12-7
Worker Protection Standard (Ag Use ONLY) 12-7
Sampling 12-7
Documentary Samples 12-7
Physical Samples 12-7
Specific Sampling Procedures 12-8
Records 12-8
Discussion with Owner/Operator, Applicator, or Agent
in Charge 12-9
FOLLOW-UP INVESTIGATION PROCEDURES 12-9
Inspector Obligations and Procedures 12-10
Conducting the Investigation 12-10
Sampling 12-11
Records 12-11
Reports 12-11
Exhibit 12-1: Notice of Use/Misuse Inspection (EPA Form 3540-25) 12-13
Exhibit 12-2: Use Investigation Report (EPA Form 3540-20) 12-14
Exhibit 12-3: Receipt for Use/Misuse Samples (EPA Form 3540-26) 12-15
Exhibit 12-4: Biosecurity Guidance 12-16
Chapter Thirteen: Residues & Environmental Sample
INTRODUCTION 13-1
SAMPLING PLAN 13-2
Review Evidence 13-3
Table of Contents • vi
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FIFRA Inspection Manual, February 2002
Obtain Technical Data From Various Sources 13-3
Pesticide(s) 13-3
Weather Data 13-4
Sample Selection 13-4
Laboratory Reporting of Sample Types 13-5
Sampling Equipment 13-5
Sampling Equipment List 13-6
Incident Site 13-6
GENERAL SAMPLING GUIDES 13-7
SAMPLE COLLECTION & PRESERVATION 13-8
Sample Containers (Guidelines) 13-8
Sample Collection Record (Guidelines) 13-9
Foliage 13-9
Discrete Foliage Sampling 13-10
Grid Pattern Foliage Sampling 13-11
Composite Foliage Sampling 13-13
Crop Damage Residue Incidents 13-13
Human Exposure Incidents 13-14
Sample Collection 13-14
Property Loss Incidents 13-15
Agricultural Pesticide Misuse 13-17
Structural Pesticide Misuse 13-18
Discrete Soil Sampling (Known Depth) 13-18
Soil Sampling In Furrowed Fields 13-19
Discrete Soil Sampling (Known Depth, Furrowed Field) 13-19
Single Rows 13-19
Double Rows 13-29
Grid Pattern Soil Sampling 13-20
Gradient Soil Sampling 13-20
Composite Soil Sampling 13-21
Discrete Sediment Sampling 13-21
Water 13-21
Discrete Surface Water Sampling 13-22
Air 13-22
Air Sampling Indoors 13-23
Air Sampling Outdoors 13-23
Pesticide Formulations (Technical Grade) 13-23
Tank Mix 13-24
Animals, Fish, Honeybee Sampling 13-25
Surface (Wipe) Sampling 13-26
Discrete Surface Sampling 13-26
Grid Pattern Surface Sampling 13-27
Gradient Surface Sampling 13-28
Clothing 13-28
SAMPLE STORAGE, PRESERVATION, AND SHIPPING 13-28
Storage and Preservation 13-29
Shipping Procedures 13-32
Hazardous Materials Shipments - UPS & FEDEX Procedure 13-33
Investigator's Shipment Procedures 13-34
UPS Shipments 13-34
FedEx Shipments 13-37
Exhibit 13-1: FedEx Dangerous Goods Airbill 13-42
Table of Contents • vii
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FIFRA Inspection Manual, February 2002
Chapter Fourteen: Pesticide Import and Export Program
AUTHORITY 14-1
OBJECTIVE 14-2
REQUIREMENTS 14-2
Exports 14-2
EPA Registered Pesticides That Are Exported with EPA
Registered Labels 14-2
Unregistered Pesticides Which Are Similar in Use and Composition
to a Registered Pesticide, as Defined in the Export Policy 14-2
PROCEDURES 14-3
Exports 14-3
Inspection and Sampling 14-3
Pre-inspection Activities (Regional Office Function) 14-4
On-Site Inspection Activities (Regional/State Function) 14-4
Imports 14-6
Import of Unregistered Pesticides 14-6
Import of Pesticides That Are Exempt From FIFRA
Regulations 14-7
Import of Registered Pesticides and Devices 14-7
Regional Office 14-7
Customs 14-9
Inspections and Sampling 14-9
Import Sampling 14-9
Inspection Without Sampling 14-10
Regional Office Procedure After Inspection 14-10
Merchandise Complying With the Act 14-10
Merchandise Not Complying With the Act 14-10
Exhibit 14-1: 40 CFR Sections 168.65 to 168.85 14-12
Exhibit 14-2: FIFRA Export Inspection Checklist 14-22
Exhibit 14-3: Pesticide Registration (PR) Notice 99-1 14-25
Exhibit 14-4: Notice of Arrival of Pesticides and Devices (EPA Form
3540-1) 14-28
Exhibit 14-5: 19 CFR Sections 12.110 to 12.117 14-29
Exhibit 14-6: FIFRA Import Inspection Checklist 14-31
Exhibit 14-7: Model Release Notice 14-33
Exhibit 14-8: Model Notice of Refusal of Admission 14-34
Exhibit 14-9: Model Notice of Detention and Hearing 14-35
Exhibit 14-10: 19 CFR Section 12.1 14-36
Exhibit 14-11: 19 CFR Sections 113.61 to 113.62 14-37
Exhibit 14-12: 19 CFR Sections 142.21 to 142.22 14-40
Chapter Fifteen: Warrants
AUTHORITY 15-1
OBJECTIVE 15-1
POLICY 15-1
In General 15-1
Impact of Barlow's Decision on Conduct of FIFRA
Inspections 15-2
PROCEDURES 15-3
Obtaining the Warrant 15-3
Contact the U.S. Attorney 15-3
Requirements for Obtaining a Warrant 15-3
Executing the Warrant 15-4
Denial of Entry 15-4
Table of Contents • viii
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FIFRA Inspection Manual, February 2002
Inspecting With a Warrant 15-5
Returning the Warrant 15-6
Challenges to the Warrant 15-6
Exhibit 15-1: Conduct of Inspections After the Barlow's Decision 15-8
Exhibit 15-2: Model Affidavit in Support of Application for a Warrant 15-17
Exhibit 15-3: Model Warrant 15-19
Chapter Sixteen: Safety
INTRODUCTION 16-1
GENERAL 16-1
Safety Equipment 16-2
Eye Protection 16-2
Foot Protection 16-3
Hand Protection 16-3
Ear Protection 16-4
Nasal, Mouth, and Respiratory Protection 16-4
Head Protection 16-5
Back Protection 16-5
Clothing Protection 16-5
Safety Reminders 16-5
Awareness 16-6
PHYSICAL HAZARDS 16-7
Sampling Trucks and Trailers 16-7
Sampling Rail Cars 16-8
Boxcars 16-8
Hopper Cars 16-9
Sampling Bins and Tanks 16-10
Sampling Bagged or Packed Products 16-10
Sampling Bulk Bagged Products (Large Volume Bags) 16-11
GENERAL SAFETY PRECAUTIONS 16-11
Man-Lifts and Cage-Type Elevators 16-11
Man-lifts 16-11
Cage-Type Elevators 16-11
Ladder Safety 16-11
Lifting Safety 16-12
Machine and Equipment Safety 16-12
Safety Signs 16-12
Electrical Safety 16-13
Hazardous Materials 16-13
Exposure To Hazardous Materials 16-14
Confined Spaces 16-15
Hazards 16-16
Entry and Exit 16-16
Inspector Responsibilities 16-16
Environmental Biological Hazards 16-16
Natural Protection 16-17
How Pathogens Enter The Body 16-17
Common Biological Hazards 16-17
Encountering Biological Hazards 16-20
Protecting Against Environmental Pathogens 16-21
Travel Safety 16-22
Vehicle Safety 16-22
Personal Safety 16-23
Lodging Safety 16-23
Table of Contents • ix
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FIFRA Inspection Manual, February 2002
Chapter Seventeen: Appearing as a Witnes
OBJECTIVE 17-1
PREHEARING PREPARATION AND PERSONAL APPEARANCE 17-1
GENERAL CONDUCT IN COURTROOM AND VICINITY 17-2
PROPER TECHNIQUE ON THE WITNESS STAND 17-3
THE DIRECT EXAMINATION 17-4
Laying the Foundation For Your Testimony 17-4
Your Testimony 17-4
CROSS EXAMINATION 17-5
PROPER CONDUCT AFTER TRIAL 17-6
EXPERT WITNESS 17-7
Chapter Eighteen: FIFRA Criminal Enforcement
INTRODUCTION 18-1
THE CRIMINAL PROVISIONS OF FIFRA 18-1
THE STATE AND FEDERAL ROLES IN CRIMINAL ENFORCEMENT
OF FIFRA 18-2
FIFRA'S RELATIONSHIP TO OTHER FEDERAL CRIMINAL LAWS 18-2
OVERVIEW OF CRIMINAL ENFORCEMENT 18-3
Special Attention to Defendant's Rights 18-3
Criminal Enforcement at EPA 18-3
RECOGNIZING POTENTIAL CRIMINAL VIOLATIONS 18-4
Criminal Enforcement Compared to Civil Enforcement 18-5
Searches 18-5
Compelling the Production of Information 18-6
Charging the Commission of a Crime 18-6
Discovery 18-6
Burden of Proof 18-7
Penalties 18-7
Criminal Investigations 18-8
Initiating an Investigation 18-8
Conducting a Criminal Investigation 18-8
Security of Criminal Investigations 18-9
Parallel Criminal and Civil Proceedings 18-9
Compliance with the Jencks Act 18-10
Participation in Grand Jury Investigation 18-11
CASE STUDIES 18-11
Case Study No. 1 18-11
Case Study No. 2 18-12
Case Study No. 3 18-12
Chapter Nineteen: Restricted-Use Pesticides: Dealer and Applicator Record
Inspections
AUTHORITY 19-1
OBJECTIVES 19-2
POLICY 19-2
RUP Dealer Records 19-2
Sales to Certified Applicators 19-2
Sales to Uncertified Persons 19-3
RUP Applicator Records 19-3
PROCEDURES 19-3
RUP Dealer Inspection 19-4
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FIFRA Inspection Manual, February 2002
RUP Applicator Inspection 19-4
Chapter Twenty: Preparing Inspection Report
INTRODUCTION 20-1
PURPOSE OF WRITTEN REPORTS 20-1
Communicate 20-1
Provide a Basis for Compliance Determination/Action 20-1
FIVE STEPS IN WRITING A NARRATIVE REPORT 20-2
Step 1 - Plan 20-2
Step 2 - Organize the material 20-2
Step 3 - Write 20-2
Step 4 - Evaluate 20-2
Step 5 - Rewrite 20-3
Essentials of Good Reports 20-3
CBI CONSIDERATIONS 20-4
REPORT FORMAT 20-5
Exhibit 20-1: FIFRA Establishment Inspection Report 20-6
Exhibit 20-2: Example of Separate Memorandum of Inspector's Findings 20-9
Exhibit 20-3: FIFRA Use Investigation Report 20-10
Appendix A: FIFRA Pesticide Sampling Procedures A-l
Appendix B: FIFRA Interviewing Techniques B-l
Appendix C: FIFRA High Visibility Incidents C-l
Appendix D: FIFRA Media Interaction D-l
Appendix E: FIFRA Genetically Modified Plant Pesticides E-l
Appendix F: Inspector Credentials F-l
Appendix G: Small Business Regulatory Enforcement and Fairness Act
(SBREFRA) G-l
Appendix H: Safety and Health Requirements for EPA Compliance
Inspectors Fact Sheet H-l
Appendix I: Electronic Records 1-1
Appendix J: Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) J-l
Table of Contents • xi
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Chapter One
ADMINISTRATION
Table of Contents
rage
INTRODUCTION 1-1
STANDARDS OF PROFESSIONAL CONDUCT 1-2
PROFESSIONAL ATTITUDE 1-2
ATTIRE 1-3
INDUSTRY, PUBLIC, AND CONSUMER RELATIONS 1-3
GIFTS, FAVORS, AND LUNCHEONS 1-3
RECORDKEEPING 1-3
Time 1-3
Travel 1-4
KNOWLEDGE REQUIRED OF AN INSPECTOR 1-4
DOCUMENTARY SUPPORT 1-7
Field Notebooks 1-7
Inspection Entries 1-7
Statements 1-8
Photographs 1-9
Drawings and Maps 1-10
Printed Matter 1-10
Mechanical Recordings 1-10
DISCLOSURE OF OFFICIAL INFORMATION 1-10
Requests for Information by the Trade or Public 1-10
Confidential Information 1-11
Procedures for FIFRA CBI Acquired During An Inspection 1-12
Obtaining CBI by an Authorized Inspector 1-12
Obtaining CBI by an Unauthorized Inspector Through
Voluntary Access 1-12
Exhibit 1-1: List of EPA Federal Forms Used for FIFRA 1-14
Chapter One • Administration • 1-i
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CHAPTER ONE
ADMINISTRATION
This manual is intended to provide guidance to inspectors
conducting pesticide inspections under the authority of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended.
Procedures and forms have been recommended for federal
inspections, but equivalent State procedures and State forms may
be substituted where appropriate.
EPA forms are available from the EPA warehouse in Cincinnati.
Some forms are available at EPA's Form Smart site:
dcwww.wic.epa.gov. For a complete listing of the forms and where
to obtain them, see Exhibit 1-1.
INTRODUCTION
The role of the FIFRA inspector in the area of enforcement is to
gather accurate information that will enable the U.S. Environmental
Protection Agency (EPA) to protect human health and the
environment from unsafe and ineffective pesticides and unlawful
sale, distribution, or use of pesticides. An energetic enforcement
program, fairly but firmly administered, is the best guarantee that
EPA will be successful. An effective enforcement program is
generated by well-trained, qualified field personnel conducting
inspection activities and investigations to (1) detect violations and
(2) collect evidence necessary to successfully prosecute FIFRA
violators and to remove potentially violative pesticides from the
channels of trade. See Chapter 2 for a list of definitions.
This manual is intended to provide the inspector with standard
operating procedures. The manual contains the authorities,
objectives, responsibilities, policies, and procedures necessary for
field staff to do their job effectively. This manual is not intended to
cover every possible situation that may be confronted in an active,
dynamic inspection program. However, it should enable field
personnel to operate in an effective, knowledgeable manner in most
circumstances.
While this manual is primarily to provide guidance to EPA
inspectors (and/or State/tribal inspectors conducting Federal
inspections for EPA), it may be valuable in orienting and training
State inspectors and other Regional personnel involved in pesticide
enforcement work.
Chapter One • Administration • 1-1
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FIFRA Inspection Manual, February 2002
STANDARDS OF PROFESSIONAL CONDUCT
Through many years of inspection experience, EPA has developed
procedures and requirements that ensure ethical standards on the
part of its inspectors. These standards have been established to
protect the individual, the Agency (EPA), and industry. Because
inspectors act as officers of the United States government, they
must perform their duties with the highest degree of honesty and
integrity. In addition, they are expected to conduct themselves in a
manner that will reflect favorably on themselves and the Agency1.
As such, the following standards of ethics must be observed at all
times. The inspector shall:
* Conduct investigations within the framework of the United
States Constitution and with due consideration for
individual rights, regardless of race, sex, creed, or national
origin.
* Uphold the Constitution, laws, and regulations of the United
States and all governments therein and never be a party to
their evasion.
* Never use any information obtained confidentially in the
performance of governmental duties as a means of making
private profit.
* Never commit any act (or failure to act) in a manner that
might be construed as being motivated by personal or
private gain (conflict of interest).
*• Never discriminate by dispensing special favors or privileges
to anyone, whether for remuneration or not; and never
accept, for his/her or their families, favors or benefits under
any circumstances.
*• Develop and report facts of an investigation completely,
objectively, and accurately.
*• Make no promises of any kind; government employees
(inspectors) cannot bind government enforcement.
* Continually attempt to improve professional knowledge and
technical skill in the investigative field.
PROFESSIONAL ATTITUDE
Because the inspector is often the initial or only contact between
the Agency and industry, he/she must be tactful, courteous, and
diplomatic, while establishing an atmosphere of cooperation
through a firm but responsive attitude.
Individual States have developed their own means of ensuring ethical actions and their procedures and
requirements must also be considered at all times.
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ATTIRE
Good public relations and practical common sense require
appropriate dress for inspection activities. Protective clothing is
required for many inspections. Coveralls or other clothing is
available for this purpose. Inspectors must wear any safety
equipment that may be customary in the establishment being
inspected. Chapter 16 provides additional information on personal
protective safety equipment.
INDUSTRY, PUBLIC, AND CONSUMER RELATIONS
It is important to obtain the cooperation of and establish good
working relations with the industry, the public, and consumers. The
inspector must introduce himself/herself by name, title, and
organization, present his/her credentials, and explain the purpose
of the visit. The inspector must not speak of any product
manufacturer or person in a derogatory manner. All information
acquired in the course of an inspector's duties is to be used for
official purposes only.
See Appendix D (Media Interactions) for more information on
how to handle interviews with the media.
GIFTS, FAVORS, AND LUNCHEONS
An inspector shall not accept anything of value from the trade,
public or consumers for, or because of, any official act he/she has
performed or will perform. An inspector may, however, accept
food and refreshments of nominal value on infrequent occasions in
the ordinary course of a luncheon or dinner meeting or other
meetings or on inspection tours. This shall not be interpreted to
mean that the inspector may accept meals or refreshments when it
is proper and feasible for him/her to pay for his/her own.
RECORDKEEPING
Time
EPA employees must keep accurate records of the time they spend
working on official projects or when taking various forms of leave.
Incorrect timekeeping may result in a paycheck for an incorrect
amount, a late paycheck, or no paycheck at all. EPA employees are
urged to familiarize themselves with EPA's Pay Administration and
Leave manuals.
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Strict adherence to the procedures outlined in the manuals will
ensure that employees are properly and timely compensated for
their work. The manuals are available from Regional EPA
personnel offices.
Travel
The Resources Management Directives System (RMDS) presents
EPA's official policies and procedures on travel. The RMDS EPA
Travel Manual (2550B) contains many detailed examples to aid
EPA employees in understanding the travel-related policies and
procedures. All EPA employees who travel on official business
should familiarize themselves with the EPA Travel Manual and
Regional policies. Failure to follow travel procedures properly may
result in delayed reimbursement or no reimbursement at all.
KNOWLEDGE REQUIRED OF AN INSPECTOR
In addition to being thoroughly familiar with FIFRA and the
regulations promulgated there-under, an inspector must have
certain communication and intuitive skills in order to complete a
thorough investigation. The inspector must know how to:
* Substantiate all facts with statements of witnesses or items of
evidence.
* Collect evidence to support a successful civil action, criminal
prosecution, or seizure.
* Obtain respect, inspire confidence, and maintain the good
will of the public, industry, and consumers during
interviews.
* Conduct sampling procedures in a safe and professional
manner.
* Use good interview techniques and detect discrepancies or
lack of good faith during interviews.
* Be accurate, thorough, unbiased, and fair while conducting
an investigation/inspection.
* Testify in court.
To carry out their duties, inspectors must be thoroughly familiar
with the legal basis for their actions. Therefore, an inspector must
have a thorough knowledge of FIFRA and all regulations and
policies promulgated thereunder.
In addition, an inspector must be aware of the following federal
laws (the text of these laws can be found in hard copy or on a CD-
ROM available through the Agency):
> Clean Air Act (CAA).
* Federal Water Pollution Control Act (FWPCA)/ Clean Water
Act (CWA).
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*• Comprehensive Environmental Response, Compensation,
and Liability Act (CERCLA) and Superfund Amendments
and Reauthorization Act (SARA).
*• Endangered Species Act (ESA).
*• Emergency Planning and Community Right-To-Know Act
(EPCRA).
* Federal Food, Drug, and Cosmetics Act (FFDCA).
*• Hazardous Materials Transportation Act (HMTA).
> Occupational Safety and Health Act (OSHA).
*• Resource Conservation and Recovery Act (RCRA).
* Safe Drinking Water Act (SOWA).
*• Toxic Substances Control Act (TSCA).
* Appropriate State pesticide and environmental legislation.
The CAA addresses air pollution from stationary sources (factories
and utilities) and mobile sources (cars and trucks). It was amended
in 1990; the 1990 amendments greatly expand the scope of the
CAA. The amendments spell out in detail actions that must be
taken by the EPA, the States, and regulated industries.
The CWA (also known as the FWPCA) and establishes national
water quality goals. Water pollution from industrial and municipal
facilities is controlled primarily through permits that limit
discharges. These permits are issued under the National Pollutant
Discharge Elimination System (NPDES). NPDES permit limits are
based on effluent guidelines for specific pollutants, performance
requirements for new sources, or water quality limits. NPDES
permits also set forth schedules and time tables for construction
and installation of needed equipment.
CERCLA authorizes EPA to clean up hazardous substances at
closed and abandoned waste sites and to recover the cost of
cleanup and associated damages from responsible parties. EPA
also can take enforcement action against responsible parties to
compel them to clean up sites. The Superfund Amendments and
Reauthorization Act (SARA) amended CERCLA in 1986. SARA
made several important changes and additions to the program.
SARA stressed the importance of permanent remedies and
innovative treatment technologies in cleaning up hazardous waste
sites; required Superfund actions to consider the standards and
requirements found in other State and federal environmental laws
and regulations; provided new enforcement authorities and
settlement tools; increased State involvement in every phase of the
Superfund program; increased the focus on human health problems
posed by hazardous waste sites; encouraged greater citizen
participation in making decisions on how sites should be cleaned
up; and increased the size of the trust fund to $8.5 billion.
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SARA also required EPA to revise the Hazard Ranking System
(HRS) to ensure that it accurately assessed the relative degree of
risk to human health and the environment posed by uncontrolled
hazardous waste sites that may be placed on the National Priorities
List (NPL).
The ESA provides broad protection for species of fish, wildlife,
and plants that are listed as threatened or endangered in the U.S. or
elsewhere. Provisions are made for listing species, as well as for
recovery plans and the designation of critical habitat for listed
species. The Act outlines procedures for federal agencies to follow
when taking actions that may jeopardize listed species, and contains
exceptions and exemptions. The ESA also is the enabling
legislation for the Convention on International Trade in
Endangered Species of Wild Fauna and Flora, commonly known as
CITES. Criminal and civil penalties are provided for violations of
the ESA and the Convention.
The FFDCA authorizes the Food and Drug Administration (FDA)
to regulate foods, cosmetics, drugs, and medical devices. The law is
intended to assure the consumer that foods are pure and
wholesome, safe to eat, and produced under sanitary conditions;
that cosmetics are safe and made from appropriate ingredients; that
drugs and devices are safe and effective for their intended uses; and
that all labeling and packaging is truthful, informative, and not
deceptive. In addition, EPA determines the safety of pesticide
products and sets tolerance levels for pesticide residues in food. It
is the responsibility of FDA to enforce the tolerance levels
established by EPA.
The objective of the HMTA is to improve the regulatory and
enforcement authority of the Department of Transportation to
protect against risks to life and property which are inherent in the
transportation of hazardous materials in commerce. The HMTA
empowered the Secretary of Transportation to designate as
hazardous material any "particular quantity or form" of a material
that "may pose an unreasonable risk to health and safety or
property." Regulations apply to any person who transports, or
causes to be transported or shipped, a hazardous material; or who
manufactures, fabricates, marks, maintains, reconditions, repairs, or
tests a package or container which is represented, marked, certified,
or sold by such person for use in the transportation in commerce
of certain hazardous materials.
Congress passed the Occupational and Safety Health Act (OSHA)
to ensure worker and workplace safety. OSHA ensures that
employers provide their workers a place of employment free from
recognized hazards to safety and health, such as exposure to toxic
chemicals, excessive noise levels, mechanical dangers, heat or cold
stress, or unsanitary conditions. In order to establish standards for
workplace health and safety, OSHA created the National Institute
for Occupational Safety and Health (NIOSH) as the research
institution for the Occupational Safety and Health Administration.
RCRA provides "cradle-to-grave" management of hazardous waste,
management of solid wastes, and regulation of underground
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storage tanks that contain chemical and petroleum products. Under
RCRA, hazardous wastes are subject to controls governing their
generation, transportation, storage, and disposal. Nonhazardous
wastes are subject to EPA guidelines and criteria for managing solid
waste. Underground storage tanks that do not meet technical
standards are to be phased out or be upgraded with leak detection
systems.
Under SDWA, EPA sets standards for the quality of drinking water
served by public water systems known as maximum contaminant
levels (MCLs). Public systems are required to sample their water
periodically and report findings to the State or EPA. In addition,
they must notify consumers if they do not meet standards or have
failed to monitor or report. SDWA also regulates the injection of
materials into underground injection wells.
TSCA authorizes EPA to regulate the manufacture, distribution in
commerce and use of toxic substances. Under TSCA, chemical
manufacturers are required to notify EPA in advance if they intend
to manufacture a new product. For both new and existing
chemicals, EPA can require testing and additional information.
Based on risk-benefit analysis, EPA can prohibit or limit a
chemical's manufacture and use.
DOCUMENTARY SUPPORT
In addition to physical samples, documentary support is necessary
for an effective case. These documents may include field
notebooks, statements, copies of records, photographs, drawings
and maps, printed matter, and mechanical recordings. See Chapters
7 and 9, Pesticide Producing Establishment Inspections, and
Pesticide Product Sampling, for additional information.
Field Notebooks
The field notebook is the core of all inspection documentation. The
field notebook (preferably bound) is part of the Agency's files and
is not the inspector's personal record. (Note: Notebooks are held
indefinitely pending disposition instructions). The field notebook is
intended to provide accurate and inclusive documentation of all
inspection activities and to provide a basis for written reports. It
shall contain only facts and pertinent observations; and the
language shall be objective, factual and free of personal feelings.
Inspection Entries
It is essential for the inspector to keep detailed records of
inspections, investigations, samples collected, etc. to serve as an aid
in writing reports and giving testimony. The following types of
information shall be included in the field notebook:
*• Observations. Record all conditions, practices and other
observations that will be useful in preparing the inspection
report or will contribute to valid evidence.
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* Unusual Conditions and Problems. Note and describe in
detail any unusual conditions and problems encountered
during the course of the inspection visit.
*• General Information. List names and titles of personnel and
the activities they perform along with any statements they
may have made and other general information.
Statements
Statements may be obtained from persons having firsthand
knowledge of the facts pertinent to a potential violation. The
purpose of obtaining a statement is to record in writing, clearly and
concisely, relevant factual information so that it can be used to
document an alleged violation. Statements are similar in most
respects to an affidavit except that the statements are not made
under oath. The following procedures and considerations may be
helpful in developing a proper statement:
*• Determine the need for a statement. Will a statement provide
useful information? Is the person making the statement
qualified to do so by having personal knowledge?
*• Ascertain all the facts and record those which are relevant
and which the person can verify in court. Make sure all the
information is factual and firsthand. Avoid taking statements
that cannot be verified personally.
*• Remember to (1) use a simple narrative style (avoid stilted
language); (2) narrate the facts in the words of the person
making the statement (use the first-person singular); and (3)
present the facts in chronological order, unless the situation
calls for some other arrangement.
* Positively identify the person making the statement (name,
position, address, etc.).
*• Show why the person is qualified to make the statement.
*• Present all pertinent facts.
* Read the statement to the person (preferably in the presence
of a witness) and make any necessary changes, initialing all
corrections or changes.
*• Ask the person making the statement to write a brief
concluding paragraph indicating that he/she read and
understood the statement. This safeguard will counter a later
claim that the person did not know what he/she was signing.
*• Have the person sign the statement. The inspector must also
sign and date the statement. Be sure to provide a copy of the
statement to the signer if requested.
* If he/she refuses to sign the statement, elicit an
acknowledgment that it is true and correct, and ask for a
statement in his/her own hand to that effect (i.e., "I have
read the statement and it is true, but I am not signing it
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because..."). Failing that, declare at the bottom of the
statement that the facts were recorded as revealed and that
the person read the statement and avowed it to be true.
Attempt to have any witness to the statement sign the
statement with his/her name and address, and initial and
date the statement.
Photographs
The documentary value of photographs ranks high as admissible
evidence. Clear photos of relevant subjects, taken in proper light
and at the proper lens setting provide an objective record of the
conditions at the time of inspection.
A sharp, clearly lit photograph is often only second to the
inspector's personal observations of the subject when it applies to
case-winning evidence. Carefully select photographic equipment.
Each medium has its advantages and disadvantages.
Polaroid-type instant photos must be identified immediately with
location, date, inspector's initials, and related sample number (if
applicable). Photographs taken on film requiring developing should
be identified in the field notebook in the order they are taken. Once
developed, identification must be transferred to the photo itself. All
photo information must be recorded in the field notebook.
It is sometimes useful to photograph a subject from a point that
will indicate the location and direction of the subject. The addition
of an object of known size, such as a person or a car, will help
indicate the size of the subject.
Flash photos must not be taken in areas where there is a danger of
explosion.
To avoid difficulties arising from confidential claims surrounding
the photographs, it is recommended that all unnecessary
background be shielded or that the subject be moved before the
photographs are taken. If an instant camera is not used and a
confidentiality claim is made, the film must be processed by a
contractor authorized for access to confidential business
information.
Videography is gaining popularity in enforcement documentation.
It is instant, color, and easily viewed on common television
monitors.
Photographic documentation should tell the story with as little
narrative as possible. This can be done by shooting series of
establishing shots that show not only the medium or subject, but
one or several permanent landmarks. These landmarks can be used
for reference to establish the exact location. (The medium of
subject photographed will emphasize a specific object or event.)
Digital photography and/or video photography should include the
date and if possible, time of the photograph so that this
information is imprinted on each photograph, frame of the film,
etc. To maintain the integrity of the original photographs the
inspector shall ensure the proper chain-of-custody.
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Drawings and Maps
Schematic drawings, maps, charts, and other graphic records may
be useful in documenting a violation. They can provide graphic
clarification of site location relative to the overall facility, spill or
contamination parameters, relative height and size of the objects,
and other information which, in combination with samples,
photographs and other documentation, can produce an accurate
and complete evidence package. Drawings and maps must be
simple and free of extraneous details. Basic measurements must be
included to provide a scale for interpretation and compass points
must be included.
All drawings, maps, etc. must be identified with the inspector's
initials, the date, sample number, and any other pertinent
information (e.g., "not drawn to scale").
Printed Matter
Brochures, literature, labels, and other printed matter can provide
important information regarding a firm's conditions and operations.
These materials may be collected as documentation. All printed
matter must be identified with date, inspector's initials and related
sample numbers.
Mechanical Recordings
Records produced electronically or by mechanical apparatus can be
entered as evidence. Charts, graphs, and other "hard copy"
documents should be treated as documentation and handled
accordingly.
DISCLOSURE OF OFFICIAL INFORMATION
Requests for Information by the Trade or
Public
EPA has an "open-door" policy on releasing information to the
public. This policy is aimed at making information about EPA and
its work freely and equally available to all interested individuals,
groups, and organizations. It is also the Agency's policy to make the
fullest possible disclosure of information without unjustifiable
expense or unnecessary delay to any requester. The Freedom of
Information Act (FOIA) which dictates this policy, however, also
cites the following nine classes of exemptions to this policy:
* Matters of national defense or foreign policy.
*• Internal agency rules.
*• Information exempted by other statutes.
* Confidential Business Information (CBI) - trade secrets,
commercial or financial information.
*• Privileged inter- or intra-Agency memoranda.
*• Personal privacy.
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FIFRA Inspection Manual, February 2002
*• Investigatory records compiled for law enforcement purposes2.
> Records of financial institutions.
* Geographical or geophysical information and data concerning
wells.
It is important to know which types of information can and cannot be
released. There are four options for handling an FOIA request:
*• Release Documents. If a record in EPA's possession does not fall
into one or more of the nine exemption categories, its release is
mandatory.
*• Withhold Documents. If the document in question falls into one
or more of the nine exemption categories it may not be released.
* Partial Withholding. With regards to records containing both
exempt and nonexempt information. If the exempt portion is
reasonably segregable and will not result in an unintelligible
nonexempt record, this nonexempt information may be released.
*• Discretionary Release. If a record is legally exempt by virtue of
Exemptions 2, 5, or 7 of FOIA, it may be released at the Agency's
discretion. If a record is contained in the Privacy Act system of
records, it may not be released at the Agency's discretion.
Confidential Information
Sections 10 and 12(a)(2)(D) of FIFRA address the protection of trade
secrets, and confidential information. All confidential information
received must be marked as such and placed in a locked filing cabinet
or safe.
Only authorized persons (authorized by the Regional Administrator,
Division Director, or Branch Chief) shall be allowed access to the file.
Information marked "trade secret" or "confidential" must not be
copied unless authorized in writing by the Regional Administrator,
Division Director, or Branch Chief. The written authorization for the
copies must contain the following information:
*• The name of the recipient of the copy.
*• The intended purpose for which the copy is to be used.
*• The manner in which the copy is to be disposed of after use.
In addition, a copy of the written order permitting the copying must
remain in the file.
State inspectors performing federal inspections shall not release under FOIA or similar State law, requests,
any notes, documents, reports, etc. obtained or prepared in connection with a FIFRA inspection until such time
as enforcement proceedings are concluded. Should the State receive a FOIA or similar request for
documentaion reletive to an open or ongoing FIFRA inspection, the State shall contact the EPA Regional
FIFRA Program Office or Headquarters FIFRA Enforcement Office prior to releasing any information releative
to the FIFRA inspection.
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With regard to requests for access to confidential information, when
any member of the public or a State or local agency or any federal
agency not concerned with carrying out the Act requests access to any
information considered confidential, the person handling the request
must comply with the procedures called for in the Freedom of
Information Act Regulations, 40 CFR Part 2.
All such requests must be referred to the Regional office.
State inspectors conducting inspections using federal credentials to
conduct FIFRA section 8 and 9 inspections are NOT authorized to
access CBI. State inspectors must not attempt to obtain FIFRA CBI
when conducting inspections on behalf of EPA. However, State
statutes may permit the collection of CBI when conducting inspections
strictly under State authority and State credentials.
Procedures for FIFRA CBI Acquired During An
Inspection
An inspector must be authorized by the Regional Document Control
Officer (DCO) to have access to FIFRA CBI during an inspection or
the person claiming the information to be FIFRA CBI must voluntarily
provide it to the inspector if the inspector is not cleared for access to
CBI.
Obtaining CBI by an Authorized Inspector
The following procedures must be adhered to when an authorized
inspector receives FIFRA CBI:
*• The information received shall be marked as "FIFRA CBI" or the
red FIFRA CBI cover sheet shall be attached to the information.
*• The CBI information shall be placed in an envelope, sealed, and
marked, "CBI - To Be Opened by Addressee Only," and the
name of the Regional DCO. This envelope is then placed into
another envelope which is normally addressed and sealed, with
no indication that it contains CBI.
*• The envelope shall be handed over by the inspector to the
Regional DCO.
Obtaining CBI by an Unauthorized Inspector
Through Voluntary Access
The following procedures must be adhered to when an unauthorized
inspector receives FIFRA CBI:
*• The person claiming the information to be FIFRA CBI shall mark
the information FIFRA-CBI.
*• The person shall place the CBI marked information in an
envelope marked "CBI-To Be Opened By Addressee Only" and
the name of the Regional Document Control Officer (DCO). This
sealed envelope must then be placed into another envelope
which is normally addressed and sealed with no indication that
it contains CBI.
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FIFRA Inspection Manual, February 2002
*• The envelope may be given to the inspector for hand delivery to
the Regional DCO, or the person may mail the envelope,
certified mail, to the Regional DCO.
For more information concerning confidential information, refer to the
FIFRA Information Security Manual, which is available from the
Regional DCO.
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Exhibit 1-1: List of EPA Federal Forms used for FIFRA
Form #
Tide
Date of Revision Where to Obtain
3540-1
3540-2
3540-3
3540-4
3540-5
3540-5A
3540-13
3540-17
3540-19
3540-20
3540-25
3540-26
3540-27
3540-28
3540-41
3540-42
7500-2
8510-14
Notice of Arrival of Pesticides and Devices
Notice of Inspection
Receipt for Samples
Sample Record Jacket (Front Panel Only)
Report of Analysis
Report of Analysis (Continuation)
Copy of Invoice and Shipping Records
History of Sample
Dealer's Statement
Use Investigation Report
Notice of Pesticide Use/Misuse Inspection
Receipt for Pesticide Use/Misuse Samples
Notice of Stop Sale, Use or Removal Order
Inspector's Credentials (for States/tribes)
Chain of Custody Record
Statement
Official Sample Seal
Biological Report of Analysis
(2-00)
(01-01)
(01-01)
(01-01)
(01-01)
(01-01)
(01-01)
(01-01)
(01-01)
(01-01)
(01-01)
(01-01)
(01-01)
(01-02)
(01-01)
(07-01)
(07-75)
(01-01)
1
1
1
2
1
1
2
2
2
1
1
1
1
o
J
2
2
1
1
1. US EPA Form Orderin
E-mail:
Phone:
Fax:
Mail:
Information:
ncepiwo@,one.net
Toll Free 1-800-490-9198 or for EPA employees (513) 489-8190
(513) 489-8695
United States Environmental Protection Agency
National Service Center for Environmental Publications (NSCEP)
PO Box 42419
Cincinnati, OH 45242
2. US EPA Intranet at: dcwww.wic.epa.gov:9876/oa/forms/index.htm
3. Upon Request to: Mickey Post, US EPA/OECA/OC/AgD (2225A);
post.mickey(S!epa.gov; ph: (202) 546-4157
Chapter One • Administration • 1-14
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Chapter Two
PESTICIDE LAW AND DEFINITIONS
Table of Contents
STATUTORY AUTHORITY FOR PESTICIDE REGULATION 2-1
FIFRA 2-2
REGULATIONS, POLICIES, AND COMPLIANCE STRATEGIES 2-2
DEFINITIONS 2-3
KEY COMPLIANCE TERMS AND REQUIREMENTS 2-16
Chapter Two • Pesticide Law & Definitions • 2-i
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CHAPTER TWO
PESTICIDE LAW AND
DEFINITIONS
STATUTORY AUTHORITY FOR PESTICIDE REGULATION
Under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), as amended, pesticide products must be
registered by the EPA before they may be legally sold or
distributed in any State. EPA provides for two exemptions
from this requirement and the Administrator, by
regulation under section 25 (b) also has exempted a
number of products from the registration requirements.
EPA registers pesticides on the basis of data adequate to
show that, when used according to label directions, they
will not cause unreasonable adverse effects on human
health or the environment. FIFRA requires the Agency to
take into account economic, social, and environmental
costs and benefits. Since FIFRA was first passed,
thousands of pesticide products have been registered.
In 1972, Congress amended FIFRA to require the "re-
registration" of all existing pesticides to ensure that
previously registered pesticides meet current scientific and
regulatory standards. In 1988 FIFRA was again amended
to establish a time table for completion of registration by
2005, and the requirement for annual maintenance fees for
active pesticide products.
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FIFRA Inspection Manual, February 2002
FIFRA authorizes the cancellation of registration if a
pesticide is found to cause unreasonable adverse effects on
human health or the environment. EPA may also suspend
the use of a pesticide if necessary to prevent an imminent
hazard. An emergency suspension takes effect
immediately, but under an ordinary suspension, a
registrant can request a hearing before the suspension goes
into effect to determine whether registrations of the
pesticide should be suspended.
FIFRA
FIFRA was first passed in 1947, and has been amended
numerous times, most recently by the Food Quality
Protection Act (FQPA) of August 3,1996. FIFRA provides
EPA with the authority to oversee, among other things, the
registration, distribution, sale, and use of pesticides. The
Act applies to all types of pesticides, including insecticides,
herbicides, fungicides, rodenticides, antimicrobials, and
devices. FIFRA covers both intrastate and interstate
commerce. For complete text of the Act go to
http://www.access.gpo.gov/uscode/uscmain.html.
REGULATIONS, POLICIES, AND COMPLIANCE STRATEGIES
The pesticide regulations are codified and found in the
Code of Federal Regulations, Title 40, Protection of
Environment, Chapter 1, Environmental Protection
Agency, Parts 150 to 189 (40 CFR, Parts 150-189).
The FIFRA Compliance Policies were originally developed
by the Office of Compliance Monitoring, which is now the
Office of Compliance/OECA, EPA, HQ. The Office of
Compliance/OECA, EPA, HQ prepares compliance
strategies to monitor industry compliance with
suspension/cancellation orders and major regulatory
actions taken under FIFRA. The Regional offices maintain
a complete set of the policies in the FIFRA Compliance
Program Policy Compendium.
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FIFRA Inspection Manual, February 2002
DEFINITIONS
Act When used in this manual, the term means the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as
amended. This term also includes, by reference, parts of
the Federal Food, Drug, and Cosmetics Act (FFDCA), as
amended by the Food Quality Protection Act (FQPA).
Active Ingredient The term "active ingredient" means:
(1) in the case of a pesticide other than a plant regulator,
defoliant, or desiccant, or nitrogen stabilizer, an
ingredient which will prevent, destroy, repel, or mitigate
any pest;
(2) in the case of a plant regulator, an ingredient which,
through physiological action, will accelerate or retard
the rate of growth or rate of maturation or otherwise
alter the behavior of ornamental or crop plants or the
product thereof;
(3) in the case of a defoliant, an ingredient which will
cause the leaves or foliage to drop from a plant;
(4) in the case of a desiccant, an ingredient which will
artificially accelerate the drying of plant tissue; and
(5) in the case of a nitrogen stabilizer, an ingredient
which will prevent or hinder the process of nitrification,
denitrification, ammonia volatilization, or urease
production through action affecting soil bacteria.
The amount of dermally applied toxicant necessary to
effect a 50 percent kill of the pest being tested within a
specified time period and under specified test
conditions, as prescribed in the Registration Guidelines
(40 CFR 152.3). It is expressed in weight of the chemical
per unit of body weight (mg/kg). The lower the LD-50,
the more poisonous the chemical.
A concentration of a substance, expressed as parts per
million (ppm) parts of a medium, that would be lethal to
50 percent of the test population of animals under
specified test conditions as expressed in the Registration
Guidelines (40 CFR 152.3). LC-50 is often used to
measure the toxicity of a chemical in air or water. The
lower the LC-50, the more poisonous the chemical.
Chapter Two • Pesticide Law & Definitions • 2-3
Acute Dermal Lethal Dose-50
(LD-50)
Acute Lethal Concentration-50
(LC-50)
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Acute Oral LD-50 The amount of orally administered toxicant necessary to
effect a 50 percent kill of the pest being tested under
specified test conditions as prescribed in the Registration
Guidelines (40 CFR 152.3). It is expressed in weight of
the chemical per unit of body weight (mg/kg). The lower
the LD-50, the more poisonous the chemical.
Administrator The term "Administrator" means the Administrator of
the Environmental Protection Agency.
Adulterated The term "adulterated" applies to any pesticide if:
(1) Its strength or purity falls below the professed
standard of quality as expressed on its labeling under
which it is sold.
(2) Any substance has been substituted wholly or in part
for the pesticide.
(3) Any valuable constituent of the pesticide has been
wholly or in part abstracted.
Advertising Promotional materials, either printed or broadcasted
through air, visual media, and verbal claims made by
the company representative, sales person or the Internet
intended to enhance customer sales. These materials
normally do not accompany the pesticide product in the
normal distribution and sale of the product and,
therefore, are not normally considered part of the
pesticide labeling. Note: See 40 CFR 168.22 for
clarification and enforcement information. Also see the
definition for "labeling" in this manual.
Agency The United States Environmental Protection Agency
(EPA).
Agricultural Commodity The term "agricultural commodity" means any plant, or
part thereof, or animal, or animal product, produced by
a person (including farmers, ranchers, vineyardists,
plant propagators, Christmas tree growers,
aquaculturists, floriculturists, orchardists, foresters, or
other comparable persons) primarily for sale,
consumption, propagation, or other use by man or
animals (40 CFR 171.2).
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Agricultural Emergency An "agricultural emergency" means a sudden
occurrence or set of circumstances which the agricultural
employer could not have anticipated and over which the
agricultural employer has no control, and which
requires entry into a treated area during a restricted-
entry interval, when no alternative practices would
prevent or mitigate a substantial economic loss [40 CFR
Agricultural Employer "Agricultural employer" means any person who hires or
contracts for the services of workers, for any type of
compensation, to perform activities related to the
production of agricultural plants, or any person who is
an owner of or is responsible for the management or
condition of an agricultural establishment that uses such
workers (40 CFR 170.3).
Agricultural Establishment "Agricultural establishment" means any farm, forest,
nursery, or greenhouse (40 CFR 170.3).
Agricultural Plant "Agricultural plant" means any plant grown or
maintained for commercial or research purposes and
includes, but is not limited to, food, feed, and fiber
plants; trees; turfgrass; flowers, shrubs; ornamentals;
and seedlings (40 CFR 170.3).
Amount of Pesticide Product "Amount of pesticidal product" means quantity,
expressed in weight or volume of the product, and is to
be reported in pounds for solid or semi-solid pesticides
and active ingredients or gallons for liquid pesticides
and active ingredients, or number of individual retail
units for devices (40 CFR 167.3).
Animal The term "animal" means all vertebrate and invertebrate
species, including but not limited to man and other
mammals, birds, fish and shellfish.
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Antimicrobial Pesticide The term "antimicrobial pesticide" means a pesticide
that:
(A) Is intended to:
(i) disinfect, sanitize, reduce, or mitigate growth or
development of microbiological organisms; or
(ii) protect inanimate objects, industrial processes or
systems, surfaces, water, or other chemical substances
from contamination, fouling, or deterioration caused by
bacteria, viruses, fungi, protozoa, algae, or slime; and
(B) In the intended use is exempt from, or otherwise not
subject to, a tolerance under section 408 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 346a and 348)
or a food additive regulation under section 409 of such
Act.
See section 2(ii) of the Act for excluded and included
pesticide products.
Batch A quantity of a pesticide product made in one operation
or lot or (if made in a continuous or semicontinuous
process or cycle) the quantity produced during an
interval of time to be determined by the producer (40
CFR 169.1).
Books and Records All records required pursuant to sections 8 and 9 of the
Act and 40 CFR 169.2 of the Regulations, as well as all
records in lieu thereof.
Cancellation The Administrator may cancel a registered pesticide if it
is determined that its labeling or other material required
to be submitted is not in compliance with the Act or if
the pesticide causes unreasonable adverse effects to the
environment. Note: See section 6(b) of the Act.
A registrant may request voluntary cancellation of a
product at any time.
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Certified Applicator The term "certified applicator" means any individual
who is certified under section 11 as authorized to use or
supervise the use of any pesticide which is classified for
restricted use. Any applicator who holds or applies
registered pesticides, or uses dilutions of registered
pesticides consistent with section 2(ee) of FIFRA, only to
provide a service of controlling pests without delivering
any unapplied pesticide to any person so served is not
deemed to be a seller or distributor of pesticides under
this Act.
Chemigation The application of pesticide products registered under
FIFRA and applied through irrigation systems (40 CFR
170.3).
Child Resistant Packaging Packaging that is designed and constructed to be
significantly difficult for children under 5 years of age to
open or obtain a toxic or harmful amount of the
substance contained therein within a reasonable time,
and that is not difficult for normal adults to use properly
(40 CFR 157.21).
Commercial Applicator The term "commercial applicator" means an applicator
(whether or not the applicator is a private applicator
with respect to some uses) who uses or supervises the
use of any pesticide classified for restricted use for any
purpose or on any property other than as provided
under the term of private applicator (40 CFR 171.2).
Cooperator Any person who grants permission to a permittee or a
permittee's designated participant to use an
experimental-use pesticide at an application site owned
or controlled by the cooperator (40 CFR 172.1).
Custom Blend Usually a pesticide(s)-fertilizer(s), pesticide-pesticide, or
a pesticide-animal feed mixture (40 CFR 167.3).
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Custom Blender
"Custom blender" means any establishment which
provides the service of mixing pesticides to a customer's
specifications, usually a pesticide(s)-fertilizer(s),
pesticide-pesticide, or a pesticide-animal feed mixture,
when:
Defoliant
Degradation
Desiccant
(1) The blend is prepared to the order of the customer
and is not held in inventory by the blender,
(2) the blend is to be used on the customer's property
(including leased or rented property),
(3) the pesticide(s) used in the blend bears end-use
labeling directions which do not prohibit use of the
product in such a blend,
(4) the blend is prepared from registered pesticides,
(5) the blend is delivered to the end-user along with a
copy of the end-use labeling of each pesticide used in the
blend and a statement specifying the composition of
mixture, and
(6) no other pesticide production activity is performed at
the establishment (40 CFR 167.3).
The term "defoliant" means any substance or mixture of
substances intended for causing the leaves or foliage to
drop from a plant, with or without causing abscission.
The process by which a chemical compound is reduced
to a less complex compound by the action of
microorganisms, water, air, sunlight, or other agents.
The term "desiccant" means any substance or mixture of
substances intended for artificially accelerating the
drying of plant tissue.
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Device The term "device" means any instrument or contrivance
(other than a firearm) which is intended for trapping,
destroying, repelling, or mitigating any pest or any other
form of plant or animal life (other than man and other
than bacteria, virus, or other microorganism on or in
living man or other living animals); but not including
equipment used for the application of pesticides when
sold separately therefrom. (40 CFR 167.3 and 40 CFR
169.1).
District Court The term "district court" means a United States district
court, the District Court of Guam, the District Court of
the Virgin Islands, and the highest court of American
Samoa.
Emergency Exemption Special exemption granted by the Administrator to any
federal or State agency from provisions of the Act if the
Administrator determines that emergency conditions
exist which require such an exemption. Note: See section
18 of the Act for more information.
Environment The term "environment" includes water, air, land, and
all plants and man and other animals living therein, and
the interrelationships which exist among these.
Establishment The term "establishment" means any place where a
pesticide or device or active ingredient used in
producing a pesticide is produced, or held, for
distribution or sale.
FFDCA The Federal Food, Drug, and Cosmetics Act, as amended
by the Food Quality Protection Act (FQPA).
FQPA The Food Quality Protection Act; an amendment to
FIFRA and FFDCA, August 3,1996.
Fungus The term "fungus" means any non-chlorophyll-bearing
thallophyte (that is, any non-chlorophyll-bearing plant
of a lower order than mosses and liverworts), as for
example, rust, smut, mildew, mold, yeast, and bacteria,
except those on or in living man or other animals and
those on or in processed food, beverages, or
Pharmaceuticals.
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Imminent Hazard The term "imminent hazard" means a situation which
exists when the continued use of a pesticide during the
time required for cancellation proceeding would be
likely to result in unreasonable adverse effects on the
environment or will involve unreasonable hazard to the
survival of a species declared endangered or threatened
by the Secretary of the Interior under Public Law 91-135.
Inert (Other) Ingredient The term "inert (other) ingredient" means an ingredient
which is not active.
Insect The term "insect" means any of the numerous small
invertebrate animals generally having the body more or
less obviously segmented, for the most part belonging to
the class insecta, comprising six-legged, usually winged
forms, as for example, beetles, bugs, bees, flies, and to
other allied classes of arthropods whose members are
wingless and usually have more than six legs, as for
example, spiders, mites, ticks, centipedes, and wood lice.
Label The term "label" means the written, printed, or graphic
matter on, or attached to, the pesticide or device or any
of its containers or wrappers.
Labeling The term "labeling" means all labels and all other
written, printed, or graphic matter
(A) accompanying the pesticide or device at any time or
(B) which reference is made on the label or in literature
accompanying the pesticide or device, except to current
official publications of the Environmental Protection
Agency, the United States Departments of Agriculture
and Interior, the Department of Health and Human
Services, State experiment stations, State agricultural
colleges, and other similar Federal or State institutions
or agencies authorized by law to conduct research in the
field of pesticides.
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Maintenance Applicator The term "maintenance applicator" means any
individual who, in the principal course of such
individual's employment, uses, or supervises the use of,
a pesticide not classified for restricted use (other than a
ready to use consumer products pesticide); for the
purpose of providing structural pest control or lawn pest
control including janitors, general maintenance
personnel, sanitation personnel, and grounds
maintenance personnel. The term "maintenance
applicator" does not include private applicators as
defined in section 2(e)(2); individuals who use
antimicrobial pesticides, sanitizers or disinfectants;
individuals employed by Federal, State, and local
governments or any political subdivisions thereof, or
individuals who use pesticides not classified for
restricted use in or around their homes, boats, sod farms,
nurseries, greenhouses, or other commercial property.
MinorUse Means the use of a pesticide on an animal, on a
commercial agricultural crop or site, or for the protection
of public health. Note: See section 2(11) of the Act for a
complete definition.
Misbranded Any pesticide not displaying a proper label or whose
label contains false or misleading information. Note: See
section 2(q) of the Act for a complete definition
including exceptions.
Nematode The term "nematode" means invertebrate animals of the
phylum nemathelminthes and class nematoda, that is,
unsegmented round worms with elongated, fusiform, or
sack-like bodies covered with cuticle, and inhabiting
soil, water, plants, or plant parts; may also be called
nemas or eelworms.
Nitrogen Stabilizer The term "nitrogen stabilizer" means any substance or
mixture of substances intended for preventing or
hindering the process of nitrification, denitrification,
ammonia volatilization, or urease production through
action upon soil bacteria. Note: See section 2(hh)of the
Act for exceptions.
Person The term "person" means any individual, partnership,
association, corporation, or any organized group of
persons whether incorporated or not.
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Pest The term "pest" means
(1) any insect, rodent, nematode, fungus, weed, or
(2) any other form of terrestrial or aquatic plant or
animal life or virus, bacteria, or other micro-organism
(except viruses, bacteria, or other micro-organisms on or
in living man or other living animals) which the
Administrator declares to be a pest under section
Pesticide The term "pesticide" means
(1) Any substance or mixture of substances intended for
preventing, destroying, repelling or mitigating any pest.
(2) Any substance or mixture of substances intended for
use as a plant regulator, defoliant or desiccant.
(3) Any nitrogen stabilizer, except that the term
"pesticide" shall not include any article that is a "new
animal drug" within the meaning of section 201(w) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321 (w)) that has been determined by the Secretary of
Health and Human Services not to be a new animal drug
by a regulation establishing conditions of use for the
article, or that is an animal feed within the meaning of
section 201 (x) of such Act (21 U.S.C. 321 (x)) bearing or
containing a new animal drug.
Note: See section 2(u) of the Act for a complete
definition including exceptions.
Pesticide-Producing Any site where a pesticide, device or active ingredient is
Establishment manufactured, packaged, repackaged, prepared,
processed, or held for distribution or sale (40 CFR 167).
Pesticide Product A pesticide, active ingredient, or device (40 CFR 152.3).
Pheromone A pheromone is a compound produced by an arthropod
which, alone or in combination with other such
compounds, modifies the behavior of other individuals
of the same species [40 CFR 152.25(b)].
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Plant Regulator The term "plant regulator" means any substance or
mixture of substances intended, through physiological
action, for accelerating or retarding the rate of growth or
rate of maturation, or for otherwise altering the behavior
of plants or the produce thereof. Note: See section 2(v) of
the Act for exceptions).
Private Applicator The term "private applicator" means a certified
applicator who uses or supervises the use of any
pesticide which is classified for restricted use for
purposes of producing any agricultural commodity on
property owned or rented by the applicator or the
applicator's employer or (if applied without
compensation other than trading of personal services
between producers of agricultural commodities) on the
property of another person.
Produce The term "produce" means to manufacture, prepare,
compound, propagate, or process any pesticide or
device or active ingredient used in producing a
pesticide.
Producer The term "producer" means the person who
manufactures, prepares, compounds, propagates, or
processes any pesticide or device or active ingredient
used in producing a pesticide. The dilution by
individuals of formulated pesticides for their own use
and according to the directions on registered labels shall
not of itself result in such individuals being included in
the definition of "producer" for the purposes of the Act.
Public Health Pesticide The term "public health pesticide" means any minor use
pesticide product registered for use and used
predominantly in public health programs for vector
control or for other recognized health protection uses,
including the prevention or mitigation of viruses,
bacteria, or other microorganisms (other than viruses,
bacteria, or other microorganisms on or in living man or
other living animal) that pose a threat to public health.
Registrant The term "registrant" means a person who has
registered any pesticide pursuant to the provisions of
the Act.
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Residential Use
Special Local Need (SLN)
Use of a pesticide directly to humans or pets, or
application of a pesticide in, on, or around any structure,
vehicle, article, surface or area associated with the
household, including but not limited to areas such as
non-agricultural outbuildings, non-commercial
greenhouses, pleasure boats and recreational vehicles; or
around any preschool or day care facility (40 CFR 152.3
and 40 CFR 157.21).
A State may provide registration for additional uses of
federally registered pesticides formulated for
distribution and use within that State to meet special
local needs in accord with the purposes of this Act, and
if registration for such use has not previously been
denied, disapproved, or canceled by the Administrator.
SLN registrations issued by the State may be
disapproved by the Agency [see section 24(c)(l), (2), (3),
and (4) of the Act].
State The term "State" means a State, the District of Columbia,
the Commonwealth of Puerto Rico, the Virgin Islands,
Guam, the Trust Territory of the Pacific Islands, and
American Samoa.
Suspension
To Distribute or Sell
Section 6 of FIFRA provides that if a pesticide is
determined to be an imminent hazard during the period
required for cancellation or change of registration
proceeding its use may be immediately suspended by
the Administrator upon proper notice and availability of
an expedited hearing.
The term "to distribute or sell" means to distribute, sell,
offer for sale, hold for distribution, hold for sale, hold for
shipment, ship, deliver for shipment, release for
shipment, or receive and (having so received) deliver or
offer to deliver. The term does not include the holding or
application of registered pesticides or use dilutions
thereof by any applicator who provides a service of
controlling pests without delivering any unapplied
pesticide to any person so served.
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To Use Any Registered Pesticide
in a Manner Inconsistent with Its
Labeling
Toxicity
Under the Direct Supervision of a
Certified Applicator
Unreasonable Adverse Effects on
the Environment
FIFRA Inspection Manual, February 2002
The term "to use any registered pesticide in a manner
inconsistent with its labeling" means to use any
registered pesticide in a manner not permitted by the
labeling.
Note: See section 2(ee) of the Act for exceptions.
The property of a substance or a mixture of substances
to cause any adverse affects (40 CFR 171.2).
Unless otherwise prescribed by its labeling, a pesticide
shall be considered to be applied under the direct
supervision of a certified applicator if it is applied by a
competent person acting under the instructions and
control of a certified applicator who is available if and
when needed, even though such certified applicator is
not physically present at the time and place the pesticide
is applied.
The term "unreasonable adverse effects on the
environment" means:
(1) Any unreasonable risk to man or the environment,
taking into account the economic, social, and
environmental costs and benefits of the use of any
pesticide or
(2) A human dietary risk from residues that result from a
use of a pesticide in or on any food inconsistent with the
standard under section 408 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 346a) and (40 CFR 166.3).
Violation Any act that constitutes a violation of law as cited in
FIFRA section 12 "Unlawful Acts", or pertinent State
legislation.
Vector The term "vector" means any organism capable of
transmitting the causative agent of human disease or
capable of producing human discomfort or injury,
including mosquitoes, flies, fleas, cockroaches, or other
insects and ticks, mites, or rats.
Weed The term "weed" means any plant which grows where
not wanted.
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KEY COMPLIANCE TERMS AND REQUIREMENTS
Attractants All substances or mixtures of substances (pheromones,
synthetic attractants, and certain extracts from naturally
occurring organic materials) which, through their
property of attracting certain animals, are intended to
mitigate a population of, or destroy, any vertebrate or
invertebrate animals declared to be pests. This does not
include, however, substances intended for survey or
detection purposes only.
Bin Labels Stock supply of labels that have not been affixed to the
product containers.
Bulk Pesticide Any volume of pesticide greater than 55 gallons (liquid)
or 100 pounds (solid) held in any individual container.
Distributor Label A label listing a pesticide which is supplementally
registered for a distributor by the registrant and allows a
distributor to sell and distribute the registered pesticide
under his/her own name, address, and brand name.
Drift Spray or dust drift is the physical movement of pesticide
droplets or particles through the air at the time of
pesticide application or soon thereafter from the target
site to any non- or off-target site. Spray drift shall not
include movement of pesticides to non- or off-target
sites caused by erosion, migration, volatility, or
windblown soil particles that occurs after application or
application of fumigants unless specifically addressed
on the product label with respect to drift control
requirements.
Episode Any adverse or undesirable event, either unexpected or
intentional, that results from the transportation,
handling, use, or disposal of a pesticide or the disposal
of a pesticide container.
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Experimental Use Permits (EUP) Any person accumulating information necessary to
register a pesticide for a use not previously approved is
requires to obtain an experimental use permit (EUP).
Pesticides under EUPs cannot be sold or distributed
except in limited circumstances. The application process
for an experimental use permit requires submission of
extensive data and the data required is based on the
pesticide and pesticide under consideration. Once a
permit is granted, the permitee is required to supervise
and evaluate the results of testing, submit reports, and
maintain extensive documentation (40 CFR Part 172).
Ingredient Statement The term "ingredient statement" means a statement
which contains:
Inspector
Market Place
Mutagenic
Nontarget Organism
(1) The name and percentage of each active (other)
ingredient, and the total percentage of all inert (other)
ingredients, in the pesticide, and
(2) If the pesticide contains arsenic in any form, a
statement of the percentages of total and water soluble
arsenic, calculated as elementary arsenic.
Any officer or employee of the EPA or of any State/tribe
duly authorized by the Administrator to conduct
inspections, make investigations, collect samples and
otherwise carry out the provisions of the Act. Such
persons may also be known by such designations as an
Environmental Protection Specialist, Pesticide Inspector,
Accident Investigation Officer, Compliance Officer, or
Investigator.
All places, which may also include production sites,
where pesticides or devices are held for distribution or
sale.
The property of a substance or agent to produce genetic
changes in living cells.
Those flora and fauna (including humans) that are not
intended to be controlled, killed, or detrimentally
affected in any way by a pesticide.
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No-Spray Zone
Oncogenic
Packaged, Labeled, and Released
for Shipment
Participant
Permittee
Pesticide Application
Pesticide Applicator
Pesticide Distribution
No-spray zone (also known as "buffer zone") is an area
in which direct application of the pesticide is prohibited;
this area is specified in distance between the closest
point of direct pesticide application and the nearest
boundary of a site to be protected, unless otherwise
specified on a product label.
The property of a substance or mixture of substances to
produce or induce benign or malignant tumor
formations in living animals.
This term refers to that point in the
producing-marketing process of a pesticide when (1) the
product has been produced and (2) it is the intent of the
producer that such product be introduced into
commerce.
Any person acting as a representative of the permittee
and is responsible for making available for use, or
supervising the use or evaluation of, an
experimental-use pesticide to be applied at a specific
application site.
Any applicant to whom an experimental-use permit has
been granted.
The placement of a pesticide at or on the site where the
pest control or other response is desired.
Commercial applicators and private applicators of
restricted use pesticides are required to be certified.
Certification is based on the type of applications to be
performed. Noncertified applicators of restricted use
pesticides are required to be supervised by certified or
private commercial applicators. Applicators can be
certified by U.S. EPA or by a State with an approved
certification plan (40 CFR Part 171 and applicable State
regulations).
Registered pesticides must be distributed or sold only
with the composition, packaging, and labeling approved
by U.S. EPA. Depending on the formulation of the
pesticide, it must be distributed and sold in child-
resistant packaging (40 CFR 152.130,152.132,157.20
through 157.36).
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Pesticide Formulation The substance or mixture of substances comprising all
active and inert (if any) ingredients of a pesticide
product.
Pesticide Labeling Every pesticide is required to have a label that clearly
identifies contents, source ingredients, and directions for
use. Pesticides shipped or used under an experimental
use permit are required to have their own label and
must include the statement "For Experimental Use
Only" [40 CFR 156.10(a) and 40 CFR 172.6].
Pesticide Producers (FIFRA The following producers are required to be registered
sec2(w)) (40 CFR 167.20):
(1) Any establishment where a pesticidal product is
produced, except for custom blenders;
(2) Any establishments where a substance is produced
must be registered with U.S. EPA if the producer intends
the substance to be used as an active ingredient of a
pesticide, or the producer has actual or constructive
knowledge that the substance will be used by any
person as an active ingredient of a pesticide.
(3) Any domestic establishment producing a pesticidal
product for export, or any unregistered pesticide, or any
foreign establishment producing a pesticide product for
import into the United States.
(4) Any establishment, either foreign or domestic,
which produces a pesticidal product for use under an
Experimental Use Permit, FIFRA section 18 Emergency
Exemption or section 24(c) Special Local Needs
Registration.
Producers are also required to meet reporting
requirements and maintain specific records (40 CFR
167.85 and 169.2).
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Pesticide Registration
No pesticide product can be distributed or sold in the
United States unless it is registered under FIFRA. The
application process for registration requires the
submission of extensive data to the U.S. EPA; and, the
application must be approved prior to a product being
distributed or sold in the United States. Registration is
required to be amended when there is a modification in
the composition, use, labeling, or packaging of a
registered product. Registrants are required to keep the
U.S. EPA informed of their current name, address, and
any change of their authorized agent. When there is a
transfer of the registration, specific documentation must
be submitted to the U.S. EPA and U.S. EPA approval for
received (40 CFR 152.15 through 152.46,152.122 through
152.135).
Pesticide Use Use of a pesticide or device:
(1) directly on humans or pets,
(2) in, on or around any structure, vehicle, article,
surface or area associated with the household, including
but not limited to areas such as non-agricultural
outbuildings, non-commercial greenhouses, pleasure
boats and recreational vehicles; or crops or aquatics, and
(3) in or around any preschool or day care facility.
The degree to which a material is injurious ( poisonous)
to vegetation.
Also known as "primacy." The right to conduct
investigations and take appropriate enforcement action
against pesticide use violations. The Administrator may
give a State primary enforcement responsibility for
pesticide use violations if it has adopted adequate
pesticide laws and regulations and meets other
requirements set forth in section 26(a) of the Act.
Protect Health and the The terms "protect health and the environment" and
Environment "protection of health and the environment" mean
protection against any unreasonable adverse effects on
the environment.
Phytotoxicity
Primary Enforcement
Responsibility
Chapter Two • Pesticide Law & Definitions • 2-20
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FIFRA Inspection Manual, February 2002
Re-entry The action of entering an area or site at, in, or on which a
pesticide has been applied.
Residue The active ingredient(s), metabolites, or degradation
product(s) that can be detected in the crops, soil, water,
or other component of the environment, including
humans, following the use of the pesticide.
Restricted-Entry Interval The time after the end of a pesticide application during
which entry into the treated area is restricted.
Service Technician The term "service technician" means any individual
who uses or supervises the use of pesticides (other than
a ready to use consumer products pesticide) for the
purpose of providing structural pest control or lawn pest
control on the property of another for a fee. The term
"service technician" does not include individuals who
use antimicrobial pesticides, sanitizers or disinfectants;
or who otherwise apply ready to use consumer products
pesticides.
Teratogenic The property of a substance or a mixture of substances
to produce or induce functional deviations or
developmental abnormalities, not heritable, in or on an
animal embryo or fetus.
Use Dilution Reducing a pesticide in concentration by adding water
or another diluent as specified on the label or labeling
that produces a specific concentration of the pesticide for
a particular purpose or effect.
Use Patterns The manner in which a pesticide is applied and includes
the following parameters of pesticide application: Target
pest; Crop or animals treated; Application site;
Application technique, rate, and frequency.
Chapter Two • Pesticide Law & Definitions • 2-21
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FIFRA Inspection Manual, February 2002
Worker Protection Standards When applying pesticides in a greenhouse, nursery
farm, or a forest, workers are required to abide by entry
restrictions and personal protection equipment (PPE)
requirements. Agricultural employers are required to
notify workers of pesticide applications and hazards
associated with those applications and provide safety
training. Notification is done orally and through the
positioning of signs. Agricultural employers are also
required to provide decontamination supplies to
workers for washing off pesticides and pesticide
residues. Pesticide handlers have to meet requirements
similar to agricultural employers (40 CFR Part 170).
Chapter Two • Pesticide Law & Definitions • 2-22
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Chapter Three
REGISTRATION
Table of Contents
rage
PESTICIDE REGISTRATION 3-1
Amendments of 1996 3-1
Amendments of 1988 3-1
Background on FIFRA 3-1
REGISTRATION PROCEDURES 3-5
New Registration (40 CFR 152.42) 3-6
Amended Registration (40 CFR 152.44) 3-6
Supplemental Distribution (40 CFR 152.132) 3-6
Section 24(c) Registrations (40 CFR 162.150 - 162.156) 3-7
Exhibit 3-1: Application for Registration 3-8
Exhibit 3-2: Application for Supplemental Registration of Distributor 3-9
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FIFRA Inspection Manual, February 2002
CHAPTER THREE
REGISTRATION
PESTICIDE REGISTRATION
Section 3 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) States that no person in any State may distribute or
sell to any person a pesticide that is not registered, unless exempted
by section 3(b). The Code of Federal Regulations 40 Parts 152 to
167 (40 CFR 152-167) establishes the requirements for product
registration.
Amendments of 1996
On August 3,1996, the President signed into law the Food Quality
Protection Act (FQPA) which amended FIFRA and the Federal
Food, Drug, and Cosmetic Act (FFDCA). The FQPA directly
affects pesticide registration and re-registrations.
Amendments of 1988
On October 25, 1988, the President signed into law the 1988
Amendments to FIFRA. Among other things, the amendments
required a substantial acceleration of the re-registration process for
previously registered pesticides and authorized the collection of
fees to support re-registration activities. The law also changed
EPA's responsibility and funding requirements for the storage and
disposal of suspended and canceled pesticides and the
indemnification of holders of remaining stocks of such canceled
pesticides. The provisions of the new law went into effect on
December 24,1988.
Background on FIFRA
Under FIFRA [unless exempt under section 25(b)], pesticides must
be registered by EPA before they can be sold or distributed in
commerce to any person. FIFRA sets an overall risk-benefit
standard for pesticide registration requiring that pesticides perform
their intended function, when used according to labeling directions,
without posing unreasonable risks of adverse effects on human
health or the environment.
When making pesticide registration decisions, EPA is required by
law to take into account the economic and environmental costs and
benefits of pesticide uses.
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FIFRA Inspection Manual, February 2002
FIFRA was first enacted in 1947. Thousands of pesticide products
have been registered since then. The standards for pesticide
registration have not remained the same since 1947, but have
evolved with science and public policy. In particular, test data
requirements for pesticides have increased in light of advances in
such areas as toxicology and analytical chemistry. Under FIFRA,
pesticide registrants (companies that hold pesticide registrations)
must provide all test data necessary to satisfy EPA's registration
requirements.
To ensure that previously registered pesticides measure up to
current scientific and regulatory standards, FIFRA requires the
review and "re-registration" of all existing pesticides. Of the
approximately 600 pesticide active ingredients that require
re-registration under FIFRA, EPA has issued Registration
Eligibility Decisions (REDs) for many of the pesticide active
ingredients. A RED includes a comprehensive review of all the
available data on the chemical, a list of additional data needed for a
complete re-evaluation and re-registration, and the Agency's current
regulatory position on the pesticide.
FIFRA authorizes EPA to cancel the registration of an existing
pesticide if data show that it causes unreasonable adverse effects on
human health or the environment, and for failure to pay
maintenance fees. In addition, EPA can take action to suspend the
registration of a pesticide to prevent an imminent hazard or for
failure to provide required data to support the re-registration.
Under FIFRA, EPA is required to notify all existing registrants if it
determines that additional data are required to maintain an existing
registration of a pesticide. Each registrant of such a pesticide must
provide evidence within 90 days after receipt of notification that it
is taking appropriate steps to secure the additional data.
Two or more registrants may agree to develop jointly, or to share in
the cost of developing, the required data if they agree and advise
the EPA of their intent within 90 days after notification. Any
registrant who agrees to share in the cost of producing the data can
examine and use the data in support of maintenance of the
registration. If an agreement on the terms of the data development
arrangement or procedure for reaching the agreement has not been
reached in 60 days after advising EPA, the registrants may initiate
binding arbitration proceedings by requesting the Federal
Mediation and Conciliation Service to appoint an arbitrator.
All parties to the arbitration share equally in the payment of the fee
and the expenses of the arbitrator.
If EPA determines that a registrant failed to take appropriate steps
to secure the required data within the required time, participate in a
procedure for reaching agreement concerning a joint data
development arrangement or in an arbitration proceeding, or
comply with the terms of an agreement or arbitration decision
concerning a joint data development arrangement, it may issue a
notice of intent to suspend the registrant's registration of the
pesticide for which additional data is required. The suspension
Chapter Three • Registration • 3-2
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FIFRA Inspection Manual, February 2002
becomes final and effective 30 days after receipt of the notice of
intent to suspend, unless during that time a request for hearing is
made in a timely and adequate manner, or EPA is satisfied that the
registrant has complied fully with the requirements that served as a
basis for the notice of intent to suspend.
EPA will publish in the Federal Register a notice of each
application for registration of any pesticide if it contains any new
active ingredient or if it would entail a changed use pattern. The
notice provides for a period of 30 days in which any federal agency
or any other interested person may comment.
The Registration Division, Office of Pesticide Programs,
undertakes pesticide registration and review to determine whether
registration is necessary. The Registration Division may also review
suspected violative labels obtained during inspections as part of
ECRs to determine whether they meet the labeling requirements.
A product is required to be registered if the following conditions
exist:
* A product meets the definition of a pesticide section 2(u) of
FIFRA and 40 CFR 152.15.
* The product's labeling and other material make pesticidal
claims.
* A product is represented in any manner that implies it is
being used as a pesticide.
* The person who distributes or sells the substance has actual
or constructive knowledge that the substance will be used or
is intended to be used for a pesticidal purpose.
Certain products do not meet these criteria and are not considered
to be pesticides (40 CFR152.8 and 152.10). These products
include:
* Deodorizers, bleaches, and cleaning agents.
*• Products not containing toxicants, intended only to attract
pests for survey or detection purposes, and labeled
accordingly.
*• Products that are intended to exclude pests only by
providing a physical barrier against pest access, and which
contain no toxicants, such as certain pruning paints to trees.
*• Products intended for use only for the control of fungi,
bacteria, viruses, or other microorganisms in or on living
man or animals, and labeled accordingly.
*• Products intended for use only for control of internal
invertebrate parasites or nematodes in living man or
animals, and labeled accordingly.
*• Products intended only to aid the growth of desirable plants.
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FIFRA Inspection Manual, February 2002
Other products are considered to be pesticide products but are
exempt from registration [section 25(b) of FIFRA and 40 CFR Part
152, SubpartB].
An unregistered pesticide, or a pesticide whose registration has
been cancelled or suspended may be distributed, sold, or
transferred as follows (40 CFR 152.30):
*• An unregistered pesticide may be transferred between
registered establishments operated by the same producer.
The pesticide must be labeled in accordance with 40 CFR
156.
*• An unregistered pesticide may be transferred between
registered establishments not operated by the same producer
if:
(1) the transfer is solely for the purpose of further
formulation, packaging, or labeling into a product that is
registered,
(2) each active ingredient in the pesticide at the time of
transfer is present as a result of incorporation into the
pesticide of either a registered product, or a pesticide that
is produced by the registrant of the final product, and
(3) the product is labeled in accordance with 40 CFR 156.
*• An unregistered pesticide may be distributed or sold in
accordance with the terms of an experimental use permit
issued under FIFRA section 5 if the product is labeled in
accordance with 40 CFR 172.6. In addition, an unregistered
pesticide may be distributed or sold in accordance with the
provisions of 40 CFR 172.3 (use of a pesticide for which an
experimental use permit is not required) provided the
product is labeled in accordance with 40 CFR 156.
*• An unregistered pesticide may be transferred within the
United States solely for export if it meets the following
conditions: (1) the product is prepared and packaged
according to the specifications of the foreign purchaser; and
(2) the product is labeled in accordance with 40 CFR 156.
*• An unregistered pesticide may be distributed or sold in
accordance with the terms of an emergency exemption
under FIFRA section 18 if the product is labeled in
accordance with 40 CFR 156.
*• An unregistered, suspended or cancelled pesticide may be
transferred solely for disposal in accordance with FIFRA
section 19 or an applicable Administrator's order. The
product must be labeled in accordance with 40 CFR 156.
Chapter Three • Registration • 3-4
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FIFRA Inspection Manual, February 2002
*• Existing stocks of a formerly registered pesticide that has
had its registration canceled or suspended may be
distributed or sold to the extent and in the manner specified
in an order concerning existing stocks issued by the EPA.
Other products exempt from registration include the following (40
CFR 152.25):
* Treated articles or substances. An article or substance treated
with, or containing, a pesticide to protect the article or
substance itself (for example, paint treated with a pesticide
to protect the paint coating, or wood products treated to
protect the wood against insect or fungus infestation), if the
pesticide is registered for such use.
*• Pheromones and pheromone traps. Pheromones and
identical or substantially similar compounds labeled for use
only in pheromone traps and pheromone traps in which
those compounds are the sole active ingredient(s). [see 40
CFR 152.25 (b)].
*• Preservatives for biological specimens [see 40 CFR 152.25
(c)]-
*• Vitamin hormone horticultural products consisting of
mixtures of plant hormones, plant nutrients, inoculants, or
soil amendments that meet all of the criteria in 40 CFR 152.25
(d).
*• Products consisting of foods and containing no active
ingredients, which are used to attract pests.
* Natural cedar blocks, chips, shavings, balls, chests, drawer
liners, paneling, and needles that meet all of the criteria in 40
CFR 152.25 (f).
*• Minimum risk pesticides - Exempted products. Products
containing the active ingredients listed in 40 CFR 152.25 (g)
are exempt from the requirements of FIFRA, alone or in
combination with other substances listed, provided that all
of the criteria of 40 CFR 152.25 are met.
Products exempt from registration are, however, subject to the
misbranding provisions of the Act, which require adequate labeling
and identification of products to ensure safe shipment and use.
REGISTRATION PROCEDURES
All applications for product registration (devices need not be
registered) are to be submitted to the Registration Division(s) (e.g.,
antimicrobial, insecticide, rodenticide, fungicide biotechnology),
Office of Pesticide Programs.
Chapter Three • Registration • 3-5
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FIFRA Inspection Manual, February 2002
Application procedures for registering a pesticide are codified in 40
CFR 152.40 through 152.175. FIFRA provides for several types of
pesticide registrations: new, amended, supplemental, re-registration,
renewal, and section 24(c) registrations.
New Registration (40 CFR 152.42)
Any person seeking to obtain a registration for a new pesticide
product must submit an application for registration, containing the
information specified in 40 CFR 152.50. An application for new
registration must be approved by the Agency before the product
may legally be distributed or sold, except as provided by 40 CFR
152.30.
Amended Registration (40 CFR 152.44)
An application for amended registration must be submitted when
changes are proposed in the labeling or when changes are proposed
in the formulation of the pesticide. 40 CFR 152.46 and PR Notice
98-10, however, allow registrants to make minor modifications to
their registration (label) that have no potential to cause
unreasonable adverse effects to the environment. Such changes are
submitted via "Notification;" an Application for Registration form
(EPA Form 8570-1) (Exhibit 3-1) marked "Notification" submitted
to the Document Processing Desk. Notifications are processed
separately. The following modifications can be made by
Notification:
* Adding alternate brand names.
* Adding and deleting pests (except public health pests and
termites).
* Adding indoor, non food sites for anti microbial products.
* Adding, revising or deleting advisory statements (except for
Ground water Advisory Statements).
*• Changes in packaging and related labeling statements.
* Use deletions related to Data Call-ins.
* Storage and disposal statements.
* Adding bilingual labeling and use of symbols or graphics.
*• Changing language to delete redundant labeling statements.
*• Changes in Warranty Statements.
* Other revisions (minor label changes).
Supplemental Distribution (40 CFR 152.132)
A registered product can be supplementally registered and
distributed (also known as private labels), which allows a distributor
to market the product under his/her own brand name. The
following conditions must be met:
Chapter Three • Registration • 3-6
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FIFRA Inspection Manual, February 2002
*• The product must have the same composition as the primary
registered pesticide, and is produced, labeled, and packaged
in a registered establishment operated by the same producer
(or under contract in accordance with 40 CFR 152.30).
* The product labeling must bear the same claims as the
primary product provided. Specific claims may be deleted
if by so doing no other changes are required.
* The distributed product is not repackaged (remains in the
producer's unopened container). However, distributors can
repackage and relabel provided they are registered pesticide
producing establishments and they have a contract with the
registrant for repackaging.
*• The label must bear the registration number of the primary
registered product.
* The distributor's company number must appear as a suffix to
the registration number.
*• Distributor products may bear the name and address of the
distributor.
The registrant must submit an Application for Supplemental
Registration of Distributor (EPA Form 8570-5) (Exhibit 3-2).
Section 24(c) Registrations (40 CFR 162.150 -
162.156)
Under section 24 (c), States may register a federally registered
product for additional uses if a special local need exists. In addition,
40 CFR 152.152 allows State registration of new formulations
under certain circumstances. States must notify EPA in writing
within 10 working days from the date a State issues, amends or
revokes a registration. Notification of State registrations or
amendments to registrations include the effective date of the
registration or amendment, a confidential statement of the formula
of any new product and a copy of the draft labeling reviewed and
approved by the State (provided that labeling previously approved
by EPA as part of a federal registration does not need to be
submitted). The notification of revocation of a registration by a
State must indicate the effective date of revocation and State the
reasons for revocation. Within 60 days after the effective date of
the registration or amendment, States must submit a copy of the
final printed labeling approved by the State.
EPA may request, when appropriate, that a State submit any data
used to determine that unreasonable adverse effects will not be
caused when it registers any use described in 40 CFR 162.135
(c)(l). States are required to submit two copies of the requested
data within 15 working days of receipt of this request from EPA.
The State may not issue a 24(c) registration that requires a new
food or feed tolerance.
Chapter Three • Registration • 3-7
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FIFRA Inspection Manual, February 2002
Exhibit 3-1: Application for Registration
Please read instructions on reverse before completing form.
Form Approved. OMB No. 2070-0060, Approval expires 2-28-95
United States
EPA Environmental Protection Agency
Washington, DC 20460
Registration
Amendment
Other
OPP Identifier Number
Application for Pesticide - Section I
1. Company/Product Number
4. Company/Product (Name)
2. EPA Product Manager
PM#
3. Proposed Classification
None Restricted
5. Name and Address of Applicant (Include ZIP Code)
Check if this is a new address
6. Expedited Review. In accordance with FIFRA Section
3(c)(3)(b)(i), my product is similar or identical in composition and
labeling to:
EPA Reg. No.
Product Name
Section - H
Amendment - Explain below.
Resubmission in response to Agency letter dated_
Notification - Explain below.
Final printed labels in response to
Agency letter dated
"Me Too" Application.
Other - Explain below.
Explanation: Use additional page(s) if necessary. (For section I and Section II.)
Section - IH
1. Material This Product Will Be Packaged In:
Child-Resistant Packaging
Yes
No
^Certification
must be submitted
Unit Packaging
Yes
No
If "Yes"
Unit Packaging
wgt
No. per
container
Water Soluble Packaging
Yes
No
If "Yes" Package No. per
wgt. container
2. Type of Container
Metal
Plastic
Glass
Paper
Other (Specify)_
3. Location of Net Contents Information
Label Container
4. Size(s) Retail Container
5. Location of Label Directions
6. Manner in Which Label is Affixed to Product
Lithograph
Paper glued
Stenciled
Other
Section - IV
1. Contact Point (Complete items directly below for identification of individual to be contacted, if necessary, to process this application.)
Name
Title
(Telephone No. (Include Area Code)
Certification
I certify that the statements I have made on this form and all attachments thereto are true, accurate and complete. I
acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both under
applicable law.
2. Signature
4. Typed Name
3. Title
5. Date
6. Date Application Received
(Stamped)
EPA Form 8570-1 (Rev. 3-94) Previous editions are obsolete.
Chapter Three • Registration • 3-8
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FIFRA Inspection Manual, February 2002
Exhibit 3-2: Application for Supplemental Registration of Distributor
United States
Environmental Protection Agency
Office of Pesticide Programs (7505C)
Washington, DC 20460
Notice of Supplemental Distribution of a Registered Pesticide Product
Instructions
After a registrant has obtained final registration for the basic product, the registrant may then supplementally distribute his/her
product. One form must be submitted for each distributor product and must be signed by the distributor involved. The basic
registration number and the distributor company number must be shown.
If a registrant has a potential distributor who does not have a company number assigned, she/he should have the distributor apply, on
letterhead stationary, to the Registration Division to have a number assigned prior to submitting this form to the agency.
This Notice of Supplemental Distribution must be submitted by the basic registrant. The completed form must have the concurrence
and signature of both the registrant and the distributor.
EPA Registration Number of Product
Distributor Company Number
Note: Do not submit distributor product labels
Name of Registered Product (basic product name accepted by EPA)
Distributor Product Name
Name and Address of Distributor (Type; include ZIP code)
Read All Conditions Before Signing
1. The distributor product must have the same composition as the basic product.
2. The distributor product must be manufactured and packaged by the same person who manufactures and packages the registered
basic product.
3. The labeling for the distributor product must bear the same claims as the basic product, provided, however, that specific claims
may be deleted if by doing so, no other changes to the label are necessary.
4. The product must remain in the manufacturer's unbroken container.
5. The label must bear the EPA registration number of the basic product, followed by a hyphen and the distributor's company
number.
6. Distributor product labels must bear the name and address of the distributor qualified by such terms as "packed for...",
"distributed by..."; or "sold by..." to show that the name is not that of the manufacturer.
7. All conditions of the basic registration apply equally to distributor products. It is the responsibility of the basic registrant to see
that all distributor labeling is kept in compliance with requirements placed on the basic product.
Distributor
We intend to market our product under the Distributor Product Name specified above, subject to the conditions specified in this Notice
Signature and Title of Distributor
Date
Registrant
/ agree that the distributor named above may distribute and sell the Distributor Product specified above, subject to the conditions specified in this Notice.
Signature and Title of Registrant
Date
EPA Form 8570-5 (Rev. 8-94) Previous editions are obsolete.
Chapter Three • Registration • 3-9
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Chapter Four
FEDERAL/STATE COOPERATION
Table of Contents
Page
AUTHORITY 4-1
Cooperative Enforcement Agreements 4-1
State Primacy 4-1
Referral Procedures under FIFRA Sections 26 and 27 4-2
Inspectional Authority 4-3
Inspections When the State Has Use Primacy 4-3
Nonprimacy Inspections 4-3
BACKGROUND 4-3
RESPONSIBILITY 4-4
Environmental Protection Agency 4-4
States 4-4
Exhibit 4-1: FIFRA Enforcement Policy 4-5
Chapter Four • Federal/State Cooperation • 4-i
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CHAPTER FOUR
FEDERAL/ST AT
COOPERATION
AUTHORITY
Cooperative Enforcement Agreements
Section 23 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), as amended, provides EPA the authority to enter into
cooperative agreements with the States, territories and Indian tribes
(hereinafter referred to simply as "States") to (1) delegate the
authority to cooperate in the enforcement of FIFRA and (2) assist
the States in the training and certification of pesticide applicators.
State Primacy
Sections 26 and 27 of FIFRA, as amended, set forth the conditions
under which States may receive primary enforcement responsibility
(primacy) for pesticide use violations and authorize the
Administrator to override or rescind a grant of primacy in certain
situations. On January 5,1983, EPA published in the Federal
Register (pp. 404-411) a Final Interpretive Rule to provide
operational guidance for FIFRA sections 26 and 27. The
procedures governing the rescission of State primacy enforcement
responsibility for pesticide use violations are found in 40 CFR 173.
A State may obtain primary enforcement responsibility for pesticide
use violations during any period which the Administrator
determines if the State has (1) adopted adequate pesticide use laws
and regulations; (2) adopted and implemented adequate procedures
for the enforcement of State laws and regulations; (3) kept records;
and (4) submitted reports showing compliance with (1) and (2)
above. If a State has a plan approved by the Administrator that
meets the requirements of section 11 of FIFRA and that the
Administrator determines meets the above criteria, it will have
primary enforcement responsibility for pesticide use violations. In
addition, a State that enters into a cooperative agreement with the
Administrator for the enforcement of pesticide use restrictions
under section 23 of FIFRA has primary enforcement responsibility.
Chapter Four • Federal/State Cooperation • 4-1
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FIFRA Inspection Manual, February 2002
The Administrator has primary enforcement responsibility for
States that do not have primary enforcement responsibility under
FIFRA (i.e., as of January 2002, Wyoming and half of Colorado).
Referral Procedures under FIFRA Sections 26
and 27
Section 27 of FIFRA requires EPA to refer to the States any
information the Agency receives indicating a significant violation of
pesticide use laws. In accordance with the Final Interpretive Rule
governing FIFRA sections 26 and 27, EPA in consultation and
with each State will identify, in writing, priority areas for formal
referral to the State. These priority areas will consist of those
pesticide activities in the State that present the greatest potential for
harm to health and the environment. The priority areas will be
revised on an annual basis based upon the effectiveness of the
programs in reduction of the harm associated with pesticide use in
the State. The negotiated written agreement between the State and
the Region will contain the criteria for the selection of significant
pesticide use cases.
All pesticide use cases identified as "significant" will be referred to
the State by EPA in writing, and will be formally tracked as set
forth in the Final Interpretive Rule. All other cases will be referred
to the State for information purposes and will not be formally
tracked.
An inspection is considered to be adequate if the State has (1)
followed proper sampling and other evidence gathering techniques,
(2) responded expeditiously to the referral, and (3) documented all
inculpatory or exculpatory events or information.
If the State's enforcement response is inadequate and the Region is
unable to persuade the State to correct any deficiencies through
communications with the State, the Region may pursue its own
enforcement response after notifying the State. That notification
should summarize the facts relating to the State inspection, discuss
the reasons for EPA's determination that the action is inadequate,
and state that the EPA will initiate its own enforcement action.
The State has 90 days after the notice to correct any deficiencies. If
after that time the Administrator determines that the State program
remains inadequate, the Administrator may rescind, in whole or in
part, the State's primary enforcement responsibility for pesticide
use violations.
Neither section 26 or 27of FIFRA limits the authority of the
Administrator to enforce the Act where the Administrator
determines that emergency conditions exist that require immediate
action and the State authority is unwilling or unable to respond to
the emergency.
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FIFRA Inspection Manual, February 2002
Inspectional Authority
Under the cooperative enforcement agreement program, EPA
delegates federal inspectional authority to the States for conducting
FIFRA inspections. Most States have inspectional authority similar
to FIFRA.
The following State/tribal guidelines must be used to determine
when to use federal or State credentials. The inspector must never
use both State and federal authority for the same inspection. If the
inspector initiates an inspection under State authority, but discovers
suspected violations of a federal nature, it is not necessary to issue
federal credentials prior to documenting the violations. Case law
has proven that evidence collected under either authority is
admissible as evidence as long as the inspector followed official
procedures and used official forms for the credentials under which
he/she was conducting the inspection.
Inspections When the State Has Use Primacy
State inspectors must always use State authority, State credentials,
State forms, and State procedures when conducting use/misuse
inspections where the State has primacy. Note: See Exhibit 4-1,
FIFRA Enforcement Policy (July 7,1981), at the end of this
chapter.
Nonprimacy Inspections
*• State Authority. State inspectors must use State authority,
State credentials, State forms and State procedures when
conducting inspections whenever the State has authority to
conduct the activity.
* Federal Authority. State inspectors must use federal
authority, federal credentials, federal forms, and federal
procedures when conducting inspections for which the State
does not have authority, but which are authorized by EPA
and/or FIFRA.
There also are instances where EPA has requested a 'for cause'
inspection when it is known that the case will be referred to EPA
for action. Federal credentials should be used in this case.
BACKGROUND
The cooperative enforcement agreement program establishes a
working partnership between EPA and the States/tribes for
cooperative enforcement of both federal and State pesticide laws
and regulations. The following lists some of the primary objectives
of this partnership:
*• Protect the public and the environment by ensuring
product compliance and proper use.
*• Improve coordination of the federal and State pesticide
enforcement program.
Chapter Four • Federal/State Cooperation • 4-3
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FIFRA Inspection Manual, February 2002
Work together to resolve cases and deal with problems.
Improve targeting of resources by tailoring the program to
meet the local needs and concerns of each State.
Provide more efficient use of resources through the use of
State offices and personnel.
RESPONSIBILITY
Both the EPA and the States perform different roles in the
cooperative enforcement agreement program. Some areas of
responsibility are listed below:
Environmental Protection Agency
*• Provides federal funding to assist the States through
cooperative agreements.
*• Provides national focus and oversight to the program.
*• Provides national guidance, compliance/enforcement
strategies, and policies.
*• Provides training for State/lab personnel.
* Delegates authority to States and provide federal credentials
for State inspectors to conduct inspections where State
authority is lacking.
*• Initiates federal civil and criminal enforcement actions for
violations of FIFRA that are referred to EPA by the States.
States
*• Assist with funding for the cooperative enforcement
agreement program.
*• Participate in the development of national guidance,
compliance/enforcement strategies, and policies.
*• Ensure compliance with both federal and State pesticide
laws by conducting an inspection and sampling program.
*• Initiate State enforcement actions for violations of State laws.
*• Refer fully documented cases of violations of FIFRA to EPA
for federal civil or criminal enforcement action.
* Document and refer to EPA potential violations of other
federal statutes.
Chapter Four • Federal/State Cooperation •
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FIFRA Inspection Manual, February 2002
Exhibit 4-1 - FIFRA Enforcement Policy
FIFRA ENFORCEMENT POLICY
Referral of State Misuse Cases to EPA, Section 26.2(b)
Issue:
Is it legally permissible for the Environmental Protection Agency to prosecute
Federal pesticide misuse violations which are based on evidence collected by State
inspectors following State procedures?
Policy: Yes, as long as States follow basic Constitutional evidentiary procedures,
evidence collected under State authority can be used to prosecute violations of Federal
pesticides laws.
Discussion:
Pursuant to section 26 of FIFRA, most States now exercise primary enforcement
responsibility for pesticide misuse violations. Although the Federal government retains
concurrent authority with the States to prosecute misuse violations, this power is not
ordinarily exercised.
Accordingly, States with primacy generally conduct use inspections under the
authority of State law. In the usual pesticide misuse case, State law provides ample
enforcement authority for the State to effectively prosecute misuse violations.
Consequently, the States need not generally refer misuse cases to the EPA for
prosecution under the parallel Federal authorities.
However, there are two instances where the States may choose to refer misuse
cases to EPA for Federal prosecution:
1) When the misuse is prohibited by Federal law, but not by State law and,
2) When both State and Federal law prohibit the misuse, but the State lacks
adequate resources to pursue prosecution.
When either of these types of misuse cases is referred to EPA for action, the
Agency will review the case file to ensure that the State inspection procedures adhere to
basic Constitutional guarantees. Information collected by State inspectors is not
excluded in court merely because it is gathered by State inspectors; instead it is subject
to the common law rules of evidence or to the Federal Rules of Evidence. The issue of
the admissibility of evidence derived from Sate Inspections involves the analysis of two
questions: (1) was the information and evidence obtained by State inspectors legally
Chapter Four • Federal/State Cooperation • 4-5
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FIFRA Inspection Manual, February 2002
obtained and (2) is that evidence within the scope of admissible evidence.
If both of these questions can be answered for any given information, then that evidence
may be properly introduced into civil proceeding to enforce a violation of the FIFRA.
Accordingly the wide variety of State inspection procedures do not affect the
capacity of the Agency to accept a misuse case for prosecution. States may follow their
own inspection procedures without regard to whether or not the misuse case will be
referred to the Agency. The eventual referral of the case to the Agency for prosecution
does not require a State inspector to change any existing State inspection procedures.
A. E. Conroy /I, Director
Pesticides and ifoxicl Substances
Enf orcemenKJy vi si on
JUL 7 198
Date
Chapter Four • Federal/State Cooperation • 4-6
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Chapter Five
EXPERIMENTAL-USE PERMIT INSPECTIONS
Table of Contents
Page
AUTHORITY 5-1
Unlawful Acts 5-1
OBJECTIVES 5-1
RESPONSIBILITY 5-2
The Office of Pesticide Programs (OPP), EPA 5-2
EPA Regional Offices 5-2
CONDUCTING THE EUP INSPECTION 5-3
Adverse Effects 5-4
REPORTING 5-4
Chapter Five • Experimental-Use Permit Inspections • 5-i
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CHAPTER FIVE
EXPERIMENTAL-USE
PERMIT INSPECTIONS
AUTHORITY
Section 5 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), as amended, and 40 CFR 172 of the Regulations
(Experimental Use Permits) authorizes experimental-use permit
inspections.
The Administrator is authorized to issue an experimental use
permit (EUP) after determining that the applicant needs such a
permit in order to accumulate information necessary to register a
pesticide under section 3.
Section 5(c) states that use of a pesticide under an experimental-use
permit shall be under the supervision of the Administrator and
subject to the terms, conditions, and periods of time prescribed in
the permit.
Section 5 (e) authorizes the Administrator to revoke any EUP, at
any time, if he/she finds that the terms or conditions of the permit
are being violated or that the terms or conditions are inadequate to
avoid unreasonable adverse effects on the environment. (Note:
Section l(j) of FIFRA defines "environment" to include "plant and
man and other animals.")
After publication of regulations under section 5(f) and upon
approval of the State plan by the Administrator or his/her
designee, a State agency designated by the State may issue EUPs.
Unlawful Acts
Under section 12(a)(2)(FI), it is unlawful for any person to use any
pesticide that is under an EUP contrary to the provisions of such
permit.
OBJECTIVES
The objectives of FIFRA section 5 investigations are to (1)
determine whether the terms and conditions of the permit are
Chapter Five • Experimental-Use Permit Inspections • 5-1
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FIFRA Inspection Manual, February 2002
adequate to avoid unreasonable adverse effects on the
environment; and (2) determine whether the terms and conditions
of the permit are being met.
RESPONSIBILITY
States may conduct EUP
Inspections under
cooperative enforcement
agreements.
The Office of Pesticide Programs (OPP), EPA
The Registration Divisions (Antimicrobial Division, Biopesticides
and Pollution Prevention Division, and the Registration Division)
review and evaluate applications for experimental use permits and
approve, issue, or disapprove such permits. The OPP also has the
responsibility and final authority to take such action as necessary to
modify or revoke a permit, if warranted.
OPP will furnish a copy of each EUP, the accepted label, names of
the participants, and terms of the program to the region where the
pesticide testing will occur.
EPA Regional Offices
The regional office is responsible for supervision, on a selected
basis, of the experimental uses conducted in its region. State
agencies participating in cooperative enforcement agreements may
conduct EUP inspections. Procedures will be the same as for EPA
unless modified by grant agreements or regional policy. Before
undertaking an experimental use surveillance program, the region
should contact the region where the home office of the permittee is
located to determine whether the permit has been previously
monitored. This does not preclude any region from surveying
experimental use within that region but rather seeks to avoid over
surveillance of widely distributed experimental chemicals.
Each regional office will establish its own supervision schedule
based on the following list of priorities:
*• Permits for pesticides that are completely new classes of
compounds (e.g., juvenile hormones).
*• Permits for chemicals with special potential hazards to
humans or the environment, such as:
• Highly toxic products
• Products with propensity to drift
• Products with high terrestrial or aquatic mobility
• Products of a particularly persistent nature
*• Permits for chemicals with previously registered uses that
were subject to adverse action by EPA.
*• Permits for chemicals manufactured by companies that have
a history of noncompliance, inadequate supervision, or other
indications of problems.
Chapter Five • Experimental-Use Permit Inspections • 5-2
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Review and become familiar
with the requirements of the
EUP.
FIFRA Pesticides Inspection Manual, February 2002
*• Permits for those chemicals that may potentially have a
widespread major use (e.g., chemicals that will replace a
major pesticide which has been canceled by the Agency).
*• Any other permits for which the Office of Pesticide
Programs (OPP) or the Office of Enforcement and
Compliance Assurance (OECA) has requested special
information or monitoring.
Upon learning of the names of the participants in the experimental
program, the regional office or State may contact those persons
responsible for the test program to obtain further details of the
program (i.e., dates, times, sites, etc). Such persons would include
sales representatives and field representatives. In addition, the
regional office or State may contact the permittee for additional
details regarding the program, if necessary, to expedite the
monitoring of the permit.
CONDUCTING THE EUP INSPECTION
The inspector must obtain and review a copy of the specific EUP
and its accepted label. EUPs may allow a product registered under
section 3 to be used for experimental use. The inspector should be
aware that the EUP label can permit application rates or
frequencies of use that exceeds the rate or frequency on the section
3 accepted product label. Take a copy of the EUP and label on the
inspection for reference. The following items must be checked for
compliance with the provisions of the permit in addition to any
specific instructions issued by the Regional office:
*• The labels on the containers and accompanying literature
must be the same as the accepted label and labeling.
* The products must be applied in accordance with the label
directions, precautions, and terms of the permit.
* If testing activities are taking place, such activities must be
supervised by a representative of the permittee.
*• The inspector should check for evidence of adverse effects
(e.g. worker complaints, signs of plant/crop damage from the
application of non-herbicides, etc.).
*• If evidence of adverse effects are observed, the inspector
should ask for documentation to prove that EPA
Headquarters has been notified of this adverse effect.
*• The amount of pesticide sold or provided.
* The quantities of product shipped and/or received.
*• The shipments have been made to designated participants
only.
* The disposition of food or feed that is not covered by a
tolerance.
Chapter Five • Experimental-Use Permit Inspections • 5-3
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FIFRA Inspection Manual, February 2002
*• The disposition of the unused pesticide in accordance with
permit instructions.
In certain instances, follow-up may be required to verify crop
rotation, crop destruction, grazing restrictions, etc.
Adverse Effects
The following adverse effects must be documented and reported to
EPA:
*• Accidents observed or claimed.
*• Non-target animal or bee kills (domestic or wild).
* Phytotoxicity to non-target plants (in or out of the target
site).
* Unique problems with handling, preparing, mixing, or
applying the pesticide.
* Other complaints.
REPORTING
The inspector must submit a written report to the Regional office
(or State office, if appropriate) on all permits monitored. The
report must cover all items previously mentioned, in addition to
any inspection requested by headquarters or the Regional office. If
follow-up inspections are conducted to verify (1) crop rotation, (2)
crop destruction, and (3) grazing restrictions, etc., submit a report
covering all items previously mentioned in addition to any points
requested by the Regional office.
If it appears that the terms of the permit have been violated, the
inspector must document evidence to prove the violation.
Photographs, affidavits or statements, and samples showing the
manner in which the terms of the permit are being violated must be
obtained. Physical samples should be collected in consultation with
the Regional office. The inspector must immediately report any
suspected violation to the Regional or State office to determine
what follow-up action may be required.
Chapter Five • Experimental-Use Permit Inspections • 5-4
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Chapter Six
CANCELLATION AND SUSPENSION
Table of Contents
Page
AUTHORITY 6-1
Cancellation 6-1
Suspension 6-1
Unlawful Acts 6-2
OBJECTIVE 6-2
POLICY 6-2
GENERAL 6-2
PROCEDURES 6-3
Producer Establishment Inspections 6-3
Marketplace Inspections 6-3
Use Inspections 6-4
Storage and Disposal of Suspended or Canceled Pesticides 6-4
Indemnity Payments 6-4
Chapter Six • Cancellation and Suspension • 6-i
-------
CHAPTER SIX
CANCELLATION AND
SUSPENSION
AUTHORITY
Sections 3(c)(2)(B), 4(d), and 4(f) of FIFRA provide the
Administrator the authority to cancel and/or suspend the
registration of a pesticide for failure of the registrant to provide, or
commit to provide, data required by the Agency.
Section 6 provides the Administrator the authority to cancel the
registration of a pesticide for unreasonable adverse effects on the
environment or suspend the registration if it is
Cancellation
The Administrator shall cancel the registration of a pesticide at the
end of five years unless the registrant (or other interested party
acting with the registrant's concurrence) requests renewal of the
registration before the end of the five years.
The Administrator may issue a Notice of Intent (NOI) to cancel if
it appears that the pesticide, or its labeling, or other material
required to be submitted does not comply with the provisions of
the Act, or when used in accordance with widespread and
commonly recognized practice, generally causes unreasonable
adverse effects on the environment.
The inspector should be aware that all suspended pesticides do not
present an imminent hazard. If there is any doubt as to the reason
for the suspension, treat the product as an imminent hazard.
(Note: The Regional office can provide the inspector with the
suspension reason.)
Suspension
If the Administrator determines that action is necessary to prevent
an imminent hazard during the time required for cancellation or
change in classification proceedings, the Administrator may, by
order, suspend the registration of the pesticide immediately.
Suspension can be accomplished through an ordinary suspension
or an emergency suspension under sections 6(c), 3(c)2(B), and 4 of
the Act. Under an ordinary suspension, the Administrator shall
Chapter Six • Cancellation and Suspension • 6-1
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FIFRA Inspection Manual, February 2002
notify the registrant prior to issuing any suspension order. Such
notice shall include findings pertaining to the question of
"imminent hazard." Under an emergency suspension order, the
Administrator determines that an emergency exists that does not
permit the Administrator to hold a hearing before suspending the
registration. The Administrator may issue a suspension order in
advance of notification to the registrant (see section 6(c)(3)).
Unlawful Acts
Under section 12(a)(2)(J), it is unlawful to violate any suspension
order issued under sections 3(c)(2)(B), 4, or 6. In addition, under
section 12(a)(2)(K), it is unlawful to violate any cancellation order
issued under the Act or to fail to submit a notice in accordance
with section 6(g). Under section 12 (a)(l)(A), it is unlawful to
distribute or sell any pesticide that is not registered under section 3
or whose registration has been canceled or suspended, except to
the extent that distribution or sale otherwise has been authorized by
the Administrator under FIFRA.
OBJECTIVE
To determine compliance with the Administrator's orders
concerning suspended and/or canceled products.
POLICY
It is the policy of EPA to followup all suspension and/or
cancellation orders with appropriate surveillance and regulatory
action, as dictated by the nature of the order. Compliance
monitoring strategies are generally developed for each suspension
and/or cancellation order.
GENERAL
Canceled pesticides in trade may be sold and used unless prohibited
by the terms of the order.
Suspension orders normally prohibit the distribution, sale, or use of
the pesticides named.
The Administrator may, however, under special circumstances,
permit the sale or use of existing stocks of canceled and/or
suspended pesticide products.
Chapter Six • Cancellation and Suspension • 6-2
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FIFRA Inspection Manual, February 2002
The inspector must carefully review and be familiar with the terms
of the order as terms may vary among orders and strategy. For
example, the length of grace periods allowing the temporary sale or
distribution of products are not standardized and may vary for
each order.
PROCEDURES
Producer Establishment Inspections
If canceled or suspended pesticides are discovered during a
producer establishment inspection, the inspector must take the
following steps:
* If production of a canceled or suspended product is
encountered, this information must be immediately brought
to the attention of the inspector's supervisor.
*• If the terms of the order are being violated, an official sample
must be obtained and the Regional office must be contacted
to determine whether a Stop Sale, Use or Removal Order
(SSURO) must be served. Obtain a copy of the production
record to document production date(s) and document any
shipments that may be in violation.
*• Determine whether the products are being held for disposal.
If held for disposal, inventory the lot and determine what
disposal steps have been taken.
* Determine if and when the establishment was notified of the
Administrator's order.
Marketplace Inspections
If canceled or suspended pesticides are discovered during
marketplace inspections, the inspector must take the following
actions:
*• Contact his/her supervisor immediately. The supervisor will
determine whether a Stop Sale, Use or Removal Order must
be issued.
*• Document the receipt of the shipment by the market place
establishment.
*• Document the further sale or distribution by the market
place establishment.
*• If the product was shipped in violation of a
cancellation/suspension order, the inspector must visit the
producer to determine whether other consignees may be
involved. This may require that the inspector/supervisor
coordinate this activity if the producing establishment is in
another State or EPA Region.
Chapter Six • Cancellation and Suspension • 6-3
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FIFRA Inspection Manual, February 2002
It must be noted that in documenting shipment, distribution, sale,
etc. of canceled or suspended products, individual batch numbers
of the products as well as sales records for RUN products must be
documented.
Use Inspections
If canceled or suspended pesticides are discovered during use
inspections, the inspector must contact his/her supervisor to
initiate the process for issuing a Stop Sale, Use, or Removal Order
(SSURO).
Storage and Disposal of Suspended or
Canceled Pesticides
The FIFRA amendments gave EPA the authority to regulate the
storage, transportation, and disposal of pesticides. In addition to
the authority to require data on storage and disposal methods, the
1988 Amendments authorized EPA to establish labeling
requirements for transportation, storage, and disposal of the
pesticide and its container. The law also enabled EPA, for the first
time, to take direct enforcement action against violations of storage,
disposal, and transportation requirements (see sections 19 (a) and 6
(g) of the Act). The amendments eliminated the requirement that
EPA, upon request, must accept suspended and canceled pesticides
and dispose of them at government expense. EPA may require
registrants and distributors to recall suspended and canceled
pesticide products. The Agency is authorized to require registrants
to give evidence of their financial capacity to carry out such a recall.
To facilitate any recalls of this kind, EPA may require all persons
who sell, distribute, or commercially use pesticides to notify EPA
and State and local officials of the quantities and locations of
suspended and canceled pesticides in their possession.
A registrant who wishes to become eligible for reimbursement of
storage costs incurred as a result of a recall must submit a plan of
storage and disposal of the pesticide that meets EPA's established
criteria. Registrants will be reimbursed for portions of their storage
costs that are attributable to delays in approval of storage plans.
A producer or exporter of pesticides, registrant of a pesticide,
applicant for registration of a pesticide, applicant for or holder of
an experimental use permit, commercial applicator, or any person
who distributes or sells any pesticide who possesses a pesticide that
has had its registration canceled or suspended must notify the
Administrator and appropriate State and local officials. The
notification must include the following information:
* The quantity of the pesticide in possession.
* The place at which the pesticide is stored.
Indemnity Payments
Prior to the 1988 Amendments, if EPA suspended and canceled
the registration of a pesticide, the Agency was required (under
FIFRA) to indemnify holders of the pesticide for losses suffered,
Chapter Six • Cancellation and Suspension • 6-4
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FIFRA Inspection Manual, February 2002
up to the cost of the pesticide. Moreover, FIFRA was silent as to
the source of funding for any indemnification (or disposal)
payments that could occur. Persons previously covered by
indemnification included "end users" (such as farmers and
commercial pesticide applicators) as well as pesticide formulators,
pesticide dealers, distributors, and registrants.
The 1988 Amendments ended automatic entitlement to indemnity
payments for all persons other than certain end users, and provided
that all indemnity payments made will come from the Judgement
Fund of the Treasury not from EPA's operating budget. End users
will continue to be eligible for indemnification through the
Judgment Fund.
Indemnification to anyone other than an end user may be paid
under the 1988 Amendments only if Congress provides a line-item
appropriation.
The 1988 Amendments also require all sellers of a pesticide
(including registrants and wholesalers) to reimburse the buyer for
the purchase price of a product whose registration is suspended
and canceled unless at the time of purchase the seller told the buyer
in writing that the seller would not make such refunds.
Chapter Six • Cancellation and Suspension • 6-5
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Chapter Seven
PESTICIDE PRODUCING ESTABLISHMENT AND
MARKETPLACE INSPECTIONS
Table of Contents
Page
STATUTORY AUTHORITIES 7-1
Important Definitions 7-1
INSPECTION POLICIES 7-2
INSPECTION OBJECTIVES 7-4
INSPECTION PROCEDURES 7-5
Inspection Preparation 7-5
Entry and Opening Conference 7-7
Observations and Evidence Collection 7-7
Scope of the Establishment Inspection 7-7
Official Sampling 7-8
Inspecting Books and Records 7-8
Conducting Label Reviews 7-9
Receipt for Samples and Closing Conference 7-10
PREPARING THE INSPECTION REPORT 7-12
Establishment Inspection Report 7-12
PESTICIDE-PRODUCING ESTABLISHMENTS 7-12
Authority 7-12
Domestic Establishments 7-12
Foreign Establishments 7-13
ESTABLISHMENT REGISTRATION NUMBERS 7-13
Placement on Label or Containers 7-13
PESTICIDE PRODUCTION REPORTS 7-14
Who Must Report 7-14
When to Report 7-14
Confidentiality 7-15
Child Resistant Packaging Requirements and Recordkeeping
Requirements 7-15
MARKETPLACE INSPECTIONS 7-16
Objectives 7-17
Inspector's Obligations and Procedures 7-17
When to Conduct Marketplace Inspections 7-18
Places to Inspect 7-18
Marketplace Inspections 7-19
Potential Inspection Sites 7-19
Entry 7-19
Persons Interviewed 7-19
Description of Activity 7-19
Label/Labeling Review 7-19
Pesticide Product Review 7-20
Shipping Records 7-20
Bulk Repackager Inspections 7-20
Objectives 7-20
Bulk Facilities Inspections 7-20
Inspector's Obligations and Procedures 7-20
PREPARING THE INSPECTION REPORTS 7-21
Establishment Inspection Report 7-21
Marketplace Inspection Report 7-22
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-i
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Exhibit 7-1: Notice of Inspection (EPA Form 3540-2) 7-23
Exhibit 7-2: Producer Establishment Inspection Checklist 7-25
Exhibit 7-3: Marketplace Inspection Checklist 7-28
Exhibit 7-4: Receipt for Samples (EPA Form 3540-3) 7-30
Exhibit 7-5: Report on Establishment Inspection to Determine
Compliance with FIFRA 7-32
Exhibit 7-6: Application for Registration of Pesticide-Producing
Establishments (EPA Form 3540-8) 7-36
Exhibit 7-7: Instructions for Completing EPA Form 3540-8 7-37
Exhibit 7-8: Pesticides Report for Pesticide-Producing Establishments
(EPA Form 3540-16) 7-44
Exhibit 7-9: Instructions for Completing EPA Form 3540-16 7-45
Exhibit 7-10: Conducting the Labeling Review 7-52
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-ii
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CHAPTER SEVEN
PESTICIDE
PRODUCING
ESTABLISHMENT AND
MARKETPLACE
INSPECTIONS
STATUTORY AUTHORITIES
Within the context of the following definitions and statutory
authorities, EPA has broad and explicit authority to inspect and
enforce the provisions of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) that regulate pesticides and devices and
those establishments that produce, distribute and/or sell pesticides
and devices. These inspection authorities cover the entire channels
of trade, from the product's release for shipment, through the
marketplace, to the end users of pesticides.
Important Definitions
"Establishment" - any place where a pesticide or device or active
ingredient used in producing a pesticide is produced, or held, for
distribution or sale.
"Produce" - to manufacture, prepare, propagate, compound, or
process any pesticide, any active ingredient or device, or to package,
repackage, label, relabel, or otherwise change the container of any
pesticide or device used in producing a pesticide.
"Distribute or sell" - the acts of distributing, selling, offering for
sale, holding for sale, distribution, shipping, holding for shipment,
delivering for shipment, or receiving and (having so received)
delivering or offering to deliver, or releasing for shipment to any
person in any State.
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-1
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FIFRA Inspection Manual, July 2002
The term "pesticide" is defined at section 2(u) of FIFRA, 7 U.S.C.
section 136(u), to mean: (1) any substance or mixture of substances
intended for preventing, destroying, repelling, or mitigating any
pest, (2) any substance or mixture of substances intended for use as
a plant regulator, defoliant, or desiccant, and (3) any nitrogen
stabilizer. Excluded from the definition of "pesticide" is any article
that is a "new animal drug"within the meaning of section 201(w) of
the Federal Food, Drug and Cosmetic Act (FFDCA).
Section 9(a) of FIFRA, 7 U.S.C. 136g(a), provides the primary
authority for the inspection of establishments. This statutory
authority authorizes an inspector to enter, at reasonable times, any
establishment or other place where pesticides or devices are held
for distribution or sale, for the purpose of inspecting and obtaining
samples of any pesticides or devices packaged, labeled, and released
for shipment, and samples of any containers or labeling for such
pesticides or devices. In addition, authority has been granted to
enter, at reasonable times, any place where there is being held any
pesticide, the registration of which has been suspended or canceled
for the purpose of determining compliance with section 19 of the
Act. Section 12(a)(2)(B) of FIFRA, 7 U.S.C. 136j(a)(2)(B), makes it
unlawful for any person to refuse to allow any entry, inspection, or
sampling authorized by FIFRA.
Section 8(a) of FIFRA, 7 U.S.C. section 136f(a), recites the
Administrator's authority to prescribe regulations requiring
producers, registrants, and applicants for registration to maintain
records with respect to their operations and the pesticides and
devices produced, and requires these persons to make these records
available for inspection and copying.
Section 8(b), 7 U.S.C. 135f(b), requires producers, registrants,
applicants for registration, distributors, carriers, dealers, or any
other person who distributes or sells any pesticide or device subject
to FIFRA, upon request, to make available for inspection and
copying all records showing the delivery, movement, or holding of
pesticides or devices, including the quantity, the date of shipment
and receipt, and the name of the consignor and consignee.
Section 12(a)(2)(B) of FIFRA, 7 U.S.C. section 136j(a)(2)(B), makes
it unlawful for any person to refuse to prepare, maintain, or submit
any records and reports required by or under section 5, 6, 7, 8, 11,
or 19, and to refuse to allow any entry, inspection, or copying of
records authorized by FIFRA.
INSPECTION POLICIES
Marketplace Inspections serve as a valuable inspection activity to
ensure compliance. The marketplace is a good location to check
current registered products, potential unregistered products and
cancelled and suspended products.
Establishment Inspections will either be conducted "for cause", i.e.,
as a result of a complaint received by EPA or the State concerning
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-2
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FIFRA Inspection Manual, July 2002
a potential violation, or be conducted under a "neutral
administrative inspection scheme." A neutral administrative
inspection scheme must be designed and utilized in a manner
consistent with the Supreme Court holding in Marshall v. Barlow. In
the Barlow case, the Court held that an inspection where no
violation is suspected be based on "reasonable legislative or
administrative standards" that satisfy the requirement for neutrality
in selecting establishments for inspection by using a non-arbitrary
method of targeting. A neutral administrative inspection scheme
allows for a non-arbitrary method of identifying inspection targets
and the neutral selection of establishments for inspection.
Establishment inspections under FIFRA can be conducted in two
ways: (1) with consent or (2) with a warrant when consent is (has
been) denied. The Agency expects that consensual inspections will
be the norm, and only in exceptional cases will an inspector,
working with his/her supervisor, an attorney from the Office of
Regional Counsel, and an Assistant United States Attorney, obtain
a warrant from a United States Magistrate to conduct an inspection.
Establishment inspections under State authority can be conducted
by using State authority, State credentials, and State form(s), and
must follow State inspectional protocol.
Unless it is to the advantage of EPA, for purposes of inspecting,
reviewing, and possibly copying large volumes or extremely
technical records required under the Act, targeted establishments
are generally not notified of a pending inspection under FIFRA. It
is Agency policy that inspections conducted under FIFRA are
unannounced inspections. Unannounced inspections are defined as
those inspections conducted with no prior contact with the
establishment, company or any individual of these places prior to
the arrival of the inspector at the establishment location.
An inspector is expected to take notes in a field notebook and
utilize this in the preparation of a written establishment inspection
report. The field notebook is the basis for all inspection
documentation and must contain accurate and comprehensive
documentation of all inspection activities. The language written in
the field notebook must be objective, factual, and free of personal
feelings and conclusions of law. All observed conditions that may
lead an inspector to think there may be a violation must be
meticulously documented in the field notebook. (Note: field
notes/notebooks are the property of EPA or the State and
ultimately become part of the official inspection file with all
appropriate documentation and exhibits as attachments). It should
be noted that it may be necessary to have separate field notebooks
for each inspection or clearly identify each inspection separately in
the field notebook; so copies of notes can be included into each
inspection file.
It also is Agency policy that an establishment inspection report be
written for each inspection conducted. The establishment
inspection report is a written report that objectively and factually
captures the proceedings of the inspection; including the statutory
requirements for presenting credentials, issuing a Notice of
Inspection, properly collecting samples and issuing a Receipt for
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Samples. The establishment inspection report should
document/identify the elements of proof and evidence collected by
the inspection and include: (1) documentary evidence,
(2) demonstrative evidence, (3) testimonial evidence, and (4)
physical evidence. This body of information will be utilized by an
EPA case officer in the development of an enforcement action.
EPA understands that the inspector is often called upon to provide
compliance assistance to the regulated industry during and after
establishment inspections. The inspector may observe egregious
situations that should be immediately rectified. For other violative
situations, the inspector may triage the situation and provide
compliance assistance as appropriate. The inspector must be
careful when suggesting, however, that a particular step be taken to
solve a possible violative situation. If the suggestion is wrong, and
if the facility is later found to be in noncompliance, then the ability
to pursue an enforcement action can be jeopardized or the
professional integrity of the inspector compromised. Options for
addressing an existing problem can be handled by directing the
owner, operator, or agent in charge of the establishment to an EPA
Regional office or State lead agency manager.
INSPECTION OBJECTIVES
Two broad objectives of inspections are:
*• Deter and reduce noncompliance and achieve environmental
and human health improvements by maintaining a strong,
timely, and active enforcement presence.
*• Deter noncompliance by maintaining appropriate levels of
compliance monitoring activity, particularly in priority
areas.
Objectives specific to the enforcement of FIFRA through
establishment inspections include:
* Identify those establishments at which a pesticide, device or
active ingredient is being produced, or locations where
pesticides are being re-packaged or re-labeled, to ensure
industry compliance with the registration requirements of
pesticide producing establishments.
*• Ensure industry compliance with product registration,
formulation, packaging, and labeling requirements before
and while the products are distributed into the channels of
trade; and detecting and obtaining samples of any
unregistered or misbranded pesticide being marketed at the
dealer/retailer level.
*• Ensure that restricted-use pesticides are sold/distributed in
accordance with the Act.
*• Determine whether the books and records required by the
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Act and the implementing regulations (sales records, batch
records, etc.) are being prepared, maintained and/or
submitted to the Agency, so that EPA can: (1) identify areas
of potential future harm to man and the environment for
purposes of possible suspension, cancellation, or
enforcement action; (2) identify the responsible
establishment in the event of a recall or stop sale order
which may be issued to curtail any adverse effects to
humans and the environment; (3) increase the completeness
and effectiveness of EPA recalls of suspended or canceled
pesticides; (4) identify and locate violative batches and
shipments of pesticides; and (5) determine whether
procedures for the disposal and storage of pesticides,
pesticide containers, and pesticide-related wastes are being
followed (on the label/labeling of the product).
Collect and develop evidence to support legal actions when
violations of the Act are found at establishments that
produce, distribute, and sell pesticides.
INSPECTION PROCEDURES
Establishment inspections, whether they are at a registrant,
pesticide formulator, bulk re-packager, toll manufacturer, import
broker, shipper, dealer, retailer, or distribution center must be
organized and preferably unannounced. These inspections must be
conducted in five phases: (1) inspection preparation; (2) entry and
opening conference; (3) observations and evidence collection; (4)
receipt for samples and closing conference; and (5) inspection
reporting.
Conducting all establishment inspections in this manner will ensure
that the inspector fulfills the statutory requirements for conducting
inspections authorized under sections 8 and 9 of FIFRA.
Inspection Preparation
The inspector should review the Regional Pesticide Production
Information for the particular establishment that is to be inspected
and be familiar with as much information about the establishment
as possible, e.g., corporate officers, products produced, etc.
Entry and Opening Conference
Both sections 8 and 9 of FIFRA require that the inspector present
to the owner, operator, or agent in charge of the establishment,
appropriate credentials and a written statement as to the reason for
the inspection, and a statement as to whether a violation of the law
is suspected. If no violation is suspected, an alternate and sufficient
reason must be given in writing. Each such inspection must be
commenced and completed with reasonable promptness. Section 9
of FIFRA also requires that an establishment inspection be
conducted at reasonable times (i.e., during "normal" business hours
for the type of establishment being inspected).
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Upon arrival at the establishment, the inspector must:
* Identify and introduce himself or herself to the owner,
operator, or agent in charge of the establishment
(responsible official of the facility), in a professional manner.
*• Present his/her credentials1. Note: Do not relinquish
possession of credentials and do not allow copies to be
made. See Appendix F (Inspector Credentials) for more
information.
* Request to discuss the purpose of the inspection with the
owner, operator, or agent in charge of the establishment and
any other responsible offitial(s) of the facility.
* Issue the owner, operator, or agent in charge a completed
Notice of Inspection (EPA Form 3540-2) (Exhibit 7-1), stating
the reason for the inspection, listing any suspected
violations, and signed by the inspector.
The entry procedures presented are critical to ensuring that an
inspection is conducted legally, with the informed consent of the
responsible official of the establishment, and that any evidence
gathered can be used in a consequent enforcement proceeding.
During the opening conference, the inspector must begin obtaining
the necessary relevant information on the establishment to
complete the narrative portion of the establishment inspection
report. This information includes, but is not limited to, the
following:
*• EPA Establishment Number, if the site is (or was) a pesticide
producing site, or the EPA Company Number if the site is a
registrant who contracts out for the manufacture of its
registered pesticide products yet is the sole source entry into
the domestic channels of trade.
* The proper business name, site address, mailing address and
telephone number(s) of the establishment.
*• The names and titles of the principal officers, partners, or
owners of the establishment.
* The persons attending the opening conference (complete
names, titles, telephone numbers of the responsible officials
of the establishment).
* The proper business name(s) site address(es), mailing
address(es) and telephone number(s) of all related firms.
*• The number of pesticides produced, sold, or distributed by
the establishment (including the brand names and EPA Reg.
The inspector must never relinquish his/her credentials to anyone at the establishment or allow his/her
credentials to be photocopied. The inspector credentials must remain in the control and custody of the
inspector at all times.
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No. of the pesticides)2, the number of pesticides produced,
and/or the number of pesticides distributed and/or sold by
the establishment.
* Supplemental registration agreements, contract
manufacturing agreements, bulk repackaging
authorizations, toll repackaging agreements with other
businesses regulated under FIFRA.
* Guarantees provided by the establishment or to the
establishment, pursuant to section 12(b)(l) of FIFRA.
*• Manufacturing/batch codes or lot number if present.
*• Listing of pesticide imports and contracted import brokers.
*• Listing of pesticide exports and foreign purchasers.
*• Listing of consignees who have received pesticides which
are not available for sampling at the establishment.
Observations and Evidence Collection
If the owner, operator, or agent in charge denies the inspector
access to pesticides that are packaged, labeled and deemed to have
been released into the channels of trade, or denies the inspector
access to records subject to FIFRA, or prohibits the collection of
official samples, the inspector must explain the authority to
conduct inspections under section 8 and 9 of FIFRA and that not
permitting the inspection would constitute a violation of section
12(a)(2)(B)(iii). The inspector must not indicate that this denial will
result in a subsequent inspection under a warrant, or an
enforcement action, or in any other way threaten the owner,
operator or agent in charge of the establishment. If consent to
conduct and complete the inspection is still denied, the inspector
must leave the establishment and immediately call and inform
his/her supervisor of the denial of entry. A warrant may then be
secured in order to continue the inspection (see Chapter 15,
Warrants).
Scope of the Establishment Inspection
The scope of the inspection will depend on the type of activities in
which the establishment is engaged. For example, the scope of an
inspection at a pesticide producing establishment will be broader
than an inspection at a retail lawn and garden establishment. The
scope of an inspection at a restricted use pesticide dealer
establishment will be broader than an inspection at an import
broker. The scope of an inspection at an agricultural chemical
establishment could be very complicated because the establishment
may be engaged in toll (contract) repackaging, bulk repackaging,
Though the Agency has a database on registrants and the pesticide registrations assigned to them, the
establishment may believe that they have "additional" pesticide products registered with EPA, when in
actuality some registrations have been suspended or canceled. The inspector is in the best position to
determine what the establishment/registrant understands as to the scope of currently active registered
pesticide products (including supplemental registrations) and be able to provide this information to EPA
for confirmation purposes or follow-up investigations.
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retail sale of restricted use pesticides, retail sale of general use
pesticides, custom blending, or commercial application. It is the
inspector's obligation to be thoroughly familiar with the regulatory
requirements that pertain to pesticide producing establishments
versus marketplace establishments and plan and conduct a
sufficiently complete inspection to determine compliance or non-
compliance with the statutory and regulatory requirements of
FIFRA. Custom blending, however, is not required to be
performed in a registered pesticide establishment; and custom
blended production should not be reported as pesticide production
under section 7 and 40 CFR Part 167.
Exhibits 7-2 and 7-3 may serve as guides (tools) for planning the
scope of, and completing an establishment inspection. See
Appendix B for information on proper interviewing techniques.
Official Sampling
Prior to sampling:
*• Determine if the owner or operator in charge wants
duplicate samples.
*• Make a stock survey of all the products released for
shipment.
* Conduct label reviews as described below.
* Collect official samples only from pesticides that are
packaged, labeled, and released for shipment.
Section 9 of FIFRA requires the inspector to offer the
establishment representative duplicate samples of physical samples
collected during the inspection. Prepare duplicate samples for the
establishment in the same manner as official samples (see Chapter
13). Restore the pesticide stocks to an orderly condition after
inspection and sampling. A Receipt for Sample (EPA Form 3540-
3) (Exhibit 7-4) must be issued for all samples collected, and this
document must be signed by both the inspector and the owner,
operator, or agent in charge of the establishment. The Receipt for
Sample should contain, among other information, the sample
number for each separate sample and the batch code or the lot
number of each container, product, etc.
The Agency assumes the right to take photographs of any pesticide
or device being inspected that is labeled and released for shipment
in lieu of obtaining samples of such labeling or container. If
management objects to the use of cameras in their establishment,
the inspector shall request that the material to be photographed be
moved to a nonsensitive area of the establishment (such as the
loading dock).
Inspecting Books and Records
It is expected that the books and records required to be prepared,
maintained or submitted by establishments subject to the
requirements of sections 7, 8, and 9 of FIFRA will be inspected.
The books and records inspection must be an integral part of every
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establishment inspection program. It should be noted that some
information to be obtained during these inspections may be
claimed as FIFRA confidential business information (CBI). If the
establishment inspection is conducted by a State inspector under
federal authority and using federal credentials, the inspector is not
permitted to view/obtain/copy, etc. any information which the
establishment declares to be CBI. The inspector shall provide the
company official with the name and address of the EPA Regional
FIFRA Document Control Officer (DCO), and request the owner,
agent, or person in charge to send the information/documents
directly to the EPA Regional FIFRA DCO. The inspector should
provide the responsible company official with a listing of all
requested documents/information to be sent to the EPA Regional
office. State inspectors cannot view CBI using federal
credentials. However, if the inspection is conducted under State
statute and using State credentials and State forms, the inspector
may be authorized to view CBI.
Records, therefore, must always be examined whenever a producer
establishment inspection is conducted. The scope of a records
inspection will vary according to circumstances. For the most part,
it may be confined to determining whether the required records are
being prepared and maintained in an up-to-date manner and for the
time periods required by the regulations. In-depth inspections of
certain records must be undertaken when the inspector has a
reasonable suspicion that there has been a violation, or when the
inspector has evidence of a violation and is trying to determine the
magnitude of the violation. The copying and collection of records
must always occur when collecting evidence to support the charge
of distribution or sale of an unregistered pesticide, an adulterated
pesticide and/or a misbranded pesticide.
Records must always be examined during establishment inspections
when the establishment is the primary distributor of a pesticide into
the channels of trade. Similarly, records must always be inspected,
copied and collected whenever the inspector has a reasonable
suspicion that there has been a violation of FIFRA (e.g., the
distribution of a misbranded pesticide).
Conducting Label Reviews
When examining pesticide products that are packaged, labeled, and
released for shipment, or pesticide containers and labels / labeling,
a preliminary label review must be conducted to assure that the
following information is provided:
*• The name, brand, or trademark under which the product is
sold.
*• The name and address of the producer, registrant,
supplemental registrant, distributor, or person for whom the
pesticide is produced.
*• The net contents.
*• The EPA registration number.
*• The EPA producing establishment registration number.
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Copies of the "EPA
accepted" label can be
obtained from the Pesticide
Product Labeling System
(PPLS) at:
www.epa.gov/pesticides/
pestlables.
*• An ingredient statement.
*• A signal word and other warning and/or precautionary
statements.
* The directions for use.
*• If the use classification is "Restricted Use Pesticide", this
statement must appear on the front panel of the pesticide
product.
*• Any suspected false or misleading statements as described in
40 CFR 165.10(a)(5).
If the pesticide product is for agricultural use, the label must have
the following required WPS statements:
* Application restrictions.
* 40 CFR Part 170 reference statement.
*• Product-type identification statements.
* State restrictions.
*• Warning statements using an alternate language commonly
spoken and read by workers.
* Restricted-entry statements.
* Notification-to-workers statement.
*• Personal protective equipment statements.
The prominence and legibility of pesticide product labels must be
ascertained. All words, statements, graphic representations, designs
or other information required on the label and labeling must be
clearly legible to a person with normal vision, and must be placed
with such conspicuousness (as compared with other words,
statements, designs, or graphic matter on the label) and expressed
in such terms as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and
use.
A comprehensive label review, comparing word-for-word the label
and labeling of the pesticide product in the channels of trade, with
the EPA stamped accepted label, can be performed after the
completion of the establishment inspection. This detailed
comparison of the actual product label with the EPA stamped
accepted label can be done by the inspector, or preferably by an
EPA case officer who has been assigned to review the inspector's
establishment inspection file for potential enforcement actions.
Receipt for Samples and Closing Conference
After completing all necessary observations and collecting sufficient
evidence to support compliance or non-compliance, the inspector
will hold a closing conference with establishment representatives.
It is not required that a specific individual (e.g., owner, operator, or
person in charge) attend the closing conference, but this
individual's attendance is beneficial. The individuals from the
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establishment who should participate are those employees
responsible for specific areas covered during the inspection. If
possible, the closing conference should be held in a conference
room or other appropriate setting to avoid distraction.
Section 9 of FIFRA requires that if an inspector obtains any
samples, prior to leaving the premises, the inspector shall provide a
receipt describing the samples obtained to the owner, operator, or
agent in charge by the EPA Regional office. During the closing
conference, the inspector should carefully complete the Receipt for
Samples (EPA Form 3540-3), clearly identifying each physical
sample collected by:
* Quantity of pesticide collected from a total quantity of
product in inventory.
*• Brand name.
*• EPA registration number.
*• EPA establishment registration number.
*• Active ingredient.
* Net content.
* Batch codes or lot number(s).
*• Name of registrant, producer, supplemental registrant,
distributor, or person for whom the pesticide is produced.
The inspector must also explain to the establishment representative
that upon completion of the analysis by the laboratory, the
Regional office will forward a copy of the report of analysis to the
establishment for their records.
The Receipt for Sample must be filled-out in its entirety, and signed
by both an establishment representative and the inspector. The
"top copy" or original copy of the Receipt for Sample must be left
with the owner, operator, or agent in charge of the establishment.
For copies of documentary evidence (e.g., bin labels, copies of
production records, records of receipt, or shipping records),
statements from representatives of the establishment must be
collected during the closing conference. Statements must
"authenticate" the documentary evidence as factual information
reflective of the production, distribution, sale, use or disposal of
pesticide products that are packaged, labeled, and deemed released
into the channels of trade.
The inspector should utilize the time during the closing conference
to clarify any outstanding issues found during the inspection.
Issues noted in the field notebook during the inspection need to be
addressed before the inspector leaves the establishment. In
addition, additional documentation that was not readily available
during the inspection may need to be collected by establishment
representatives and copies forwarded to the inspector. These types
of issues need to be resolved at this time.
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During the closing conference, the inspector must be prepared to
answer any questions and address any concerns that the owner,
operator, or agent in charge of the establishment may have. The
inspector must be careful to answer only those questions that are
within his/her expertise and direct the establishment
representative (s) to appropriate EPA Regional personnel on those
issues that cannot be readily addressed.
The inspector should summarize the inspection findings during the
closing conference. It is imperative that conclusive or accusatory
language is not used. Any presentation of findings must be
qualified as preliminary (unless an egregious situation is occurring
that should be corrected immediately) and stated in a concise and
factual manner. The inspector can bring to the attention of the
owner, operator, or agent in charge which violations have been
found without making judgmental statements regarding the degree
of seriousness of any violations noted, and the resulting level of
enforcement action that may result.
PREPARING THE INSPECTION REPORT
Establishment Inspection Report
A narrative report or Establishment Inspection Report (EIR) must
be completed for each establishment inspected. The purpose of
the narrative report is to capture sufficient information to
accurately portray what is taking place at the establishment with
regard to pesticide production, distribution, and/or sale. The
format of the report may vary, but the content must include, at a
minimum, the information listed in the outline presented for a
model inspection report (Exhibit 20-1).
PESTICIDE-PRODUCING ESTABLISHMENTS
Authority
Section 7 of FIFRA requires any establishment that produces any
pesticide or active ingredient used in producing a pesticide or any
device to be registered. The regulations promulgated November 6,
1973, and amended September 8,1988, are found in 40 CFR Part
167.
Domestic Establishments
An Application for Registration of Pesticide-Producing
Establishments (Form 3540-8; Exhibit 7-6) may be obtained from
the EPA Regional offices. (Instructions for completing Form
3540-8 can be found in Exhibit 7-7). The completed application
should be mailed to the EPA Regional office having jurisdiction
over the State in which the company headquarters are located.
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Foreign Establishments
The completed application for establishments in a foreign country
must be mailed to: OECA - Office of Compliance, Agriculture
Division (2225A), U. S. Environmental Protection Agency, 1200
Pennsylvania Avenue, NW; Washington, DC 20460.
ESTABLISHMENT REGISTRATION NUMBERS
Placement on Label or Containers
The establishment number (Est. No.) is a facility identifier
comprised of a company number, a two or three letter State or
country code, and a number indicating the order of the
establishment registered in a given State or country. For example:
Est. No. 80156-NY-002 would indicate the second establishment
registered for company number 80156 which is located in the State
of New York.
Example: EPA Est.l23-KY-3
The establishment number must appear on the product label, or on
the immediate container of the product. If the EPA Establishment
number cannot be seen or clearly read through the wrapping or
packaging of the pesticide container, it must also appear on the
outside container or wrapper of the product (40 CFR 156.10 (f)).
Since the reviewer may never see the actual outside container of the
product, the establishment number may not be shown on the draft
product label submitted for review by the company.
The EPA establishment number (EPA Est. No.) is often grouped
together with the EPA Registration Number (EPA Reg. No.), but
such placement is not required. Devices must be produced in
registered pesticide producing establishments, and they must have
an EPA Est. No. on the device or the device's label; however, they
do not require an EPA Registration Number.
Producers may seek approval from OECA - Office of Compliance,
Agricultural Division, (2225A), EPA, Washington, D.C., 20460, for
various techniques or formats for displaying the establishment
registration number.
The following are examples of approved formats that may be
adapted for use by pesticide producers.
For example, a company (registrant number 123) that has three
registered establishments, two in Indiana (IN) and one in
Massachusetts (MA), may print all three establishment numbers on
the label.
EPA Est. No. 123-IN-l
123-IN-2
123-MA-l
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or
EPA Est. No. 123-IN-l, -2, -MA-1
Those products produced at a given establishment can be identified
by a saw-cut, notch, arrow, or other similar indicator.
A producer may add its own code number to identify the actual
production site. A statement following the numbers tells the
inspector where to look on the container for the actual producing
establishment. For example,
"EPA Est. No. 123-IN-l (a), 123-IN-2 (b), 123-MA-l (c)
See last letter on bottom of can for actual establishment."
PESTICIDE PRODUCTION REPORTS
Who Must Report
Each registered establishment must submit an annual Pesticides
Report for Pesticide-Producing and Device Producing
Establishments (Form 3540-16, Exhibit 7-8). EPA defines
"production"as the manufacture, preparation, compound
formulation, propagation, or processing of a pesticide for sale or
distribution in the United States or for export. This includes
packaging, repackaging, labeling, re-labeling, or otherwise changing
the container of any pesticide or device.
* Establishments that produce pesticides for sale or
distribution and are engaged in other activities such as
distribution and sale of other products or custom blending
must register their establishments and report production of
only the pesticides they produce. The custom blended
products are not required to be reported. Distributors and
sellers are not required to report if they are not also
producers.
* Custom blenders that meet all conditions of the Custom
Blend Policy and engage in no other pesticide production
activity are not required to register their establishment or
submit a pesticide production report.
The pesticide report may be completed at the company
headquarters. A pesticide report, however, must be completed for
each registered establishment.
When to Report
Pesticide reports from all registered establishments must be
submitted annually, on or before March 1, even if the producer has
produced no pesticide product for that year. New registered
establishments must submit an initial pesticide report no later than
thirty (30) days after notification of their establishment registration,
and annually thereafter on or before March 1.
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Confidentiality
Section 7(d) of FIFRA states that any information reported on the
amounts of pesticides or devices produced, sold, and/or distributed
will be maintained as FIFRA Confidential Business Information
(CBI). Any request for information that is included in the Pesticide
Report must be referred to the Regional Document Control Office
(DCO) for FIFRA confidential business information.
The EPA Associate General Counsel has ruled that no State(or its
employees or representatives) will have access to any information
obtained by EPA pursuant to section 7(c) and 7(d) of FIFRA.
Child Resistant Packaging Requirements and
Recordkeeping Requirements
The inspector must be familiar with 40 CFR Part 157. The
following is a brief summary of the requirements for child resistant
packaging (CRP) of pesticides and devices:
*• The requirements for CRP containers are found at 40 CFR
157.22. The requirements specify in part that CRP is required
for all pesticide products and devices if:
• Based on testing with an appropriate test species, the
product meets certain toxicity criteria described in the
regulation.
• The product's labeling either directly recommends
residential use or reasonably can be interpreted to
permit residential use.
*• There are, however, certain exemptions to these
requirements found at 40 CFR 157.24, which states in part
that pesticides are exempt from CRP requirements if:
• The product is classified for restricted use.
• The product is packaged in large sizes.
The following summarizes the records that registrants are required
to maintain for child-resistant packaging in accordance with 40
CFR 157.36 of the regulations.
*• Description of the package to include:
• The container and its dimensions and composition.
• The closure or child-resistant mechanism including the
name of its manufacturer and the manufacturer's
designation of the closure.
* Copy of the certification statement required by 40 CFR
157.34.
* One of the following types of records verifying that each
package for the product is child resistant:
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• Test data on the package are based on the Consumer
Product Safety Commission protocol contained in 16 CFR
1700.20.
• Test data not conforming to the protocol in 16 CFR
1700.20, or a set of the measurements on the package,
together with an explanation as to why the data
demonstrate that the package is child resistant.
• Test data, whether or not confirming to the protocol in 16
CFR 1700.20, on a different package, together with an
explanation as to why such data demonstrate that the
package being used is child resistant.
• Written evidence that verifies that testing on the package
has been conducted according the protocol in 16 CFR
1700.20. Written evidence may be one of the following: a
letter or literature from the packaging supplier; letter from
the facility that conducted the testing; or specification in
the contract between the registrant or the applicant and the
packaging supplier.
*• When the container and closure are purchased separately by
the registrant:
• Information of the kinds described in 40 CFR
157.36(c)(l) through (4) showing that the closure is
child resistant.
• A written explanation of why the container is child
resistant.
*• Information showing that the closure and container are
compatible with each other, and a written explanation of
why the resulting package is child resistant.
> A combination of the records listed in 40 CFR 157.36(c)(l)
through (5).
*• Records verifying that the package meets the compatibility
and durability standards of 40 CFR 157.32(b) and (c).
If the products or devices are not packaged in CRP, the inspector
must inquire why the establishment claims that the products or
devices are exempt from the CRP requirements.
MARKETPLACE INSPECTIONS
FIFRA marketplace inspections should be conducted for the
following reasons:
*• To ensure industry compliance with product registration,
formulation, packaging, and labeling requirements and that
products are correctly distributed to the channels of the
trade.
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* To collect and develop evidence to support legal actions
when violations are found.
*• To determine whether procedures for the disposal and
storage of pesticides, pesticide containers, and pesticide-
related wastes are being followed.
Objectives
Marketplace inspections are to be conducted with the following
objectives in mind:
* To detect and obtain samples of any unregistered or
misbranded pesticides being marketed.
* To determine whether restricted-use pesticides are being
sold in accordance with the Act.
*• To review advertising material, accompanying literature,
and other labeling material to determine whether any false
or misleading claims are being made for the product.
* To obtain samples of those products that were unavailable
for sampling at the producer's establishment.
* To follow-up on recalls, stop sales, suspensions and
cancellations.
* To obtain samples of products subject to deterioration.
* To determine whether supplementary sections 18 and 24(c)
labeling has been provided by registrant/producer.
Inspector's Obligations and Procedures
The inspector should seek the most responsible individual available
at the inspection site and present his/her credentials to that person.
The owner, operator, or agent in charge should then be issued a
Notice of Inspection (EPA Form 3540-2), stating the reason for
the inspection and any suspected violations. The inspector should
explain the purpose of the inspection and the statutory authority
for such an inspection.
Once entry has been gained, the inspector should survey the
pesticides being offered for sale as follows:
*• Review the labels and/or labeling.
*• Inquire whether firm has supplemental sections 18 and 24(c)
labels and whether they are provided to those consignees
receiving the products. Obtain copies for review upon
return to your office.
*• If a violation is discovered, collect a sample.
*• If the label violation is serious enough that it may create a
hazard, the Regional supervisor should be called
immediately to discuss the advisability of placing a Stop
Sale, Use or Removal Order on the misbranded product.
(See Chapter 10 for instructions on issuing Stop Sale, Use or
Removal Orders).
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-17
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FIFRA Inspection Manual, July 2002
*• If a cancelled or suspended product is encountered, this fact
should be brought to the attention of the inspector's
supervisor, who will determine the appropriate course of
action.
* Voluntary corrective actions should be noted in the
Inspection Report.
When to Conduct Marketplace Inspections
In general, marketplace surveillance should be scheduled by
seasonal demands. For example, during the growing season, feed,
seed, and fertilizer outlets are good sources of agricultural pesticide
products. Spring and summer are the best times for swimming
pool concerns. During the winter months, urban outlets could be
surveyed for household pesticide products. Marketplace
inspections should be coordinated with other inspectional activities.
Places to Inspect
An inspector must always remain alert to the distribution pattern of
pesticides in his/her area. These pesticide distributors, both
wholesale and retail, should be kept under surveillance to be sure
that only registered and properly labeled pesticides are being sold.
The following lists some suggested distribution points for
inspecting pesticides:
*• Animal health and veterinarian suppliers
*• Hardware stores
* Barber and beauty supply dealers
*• Chemical suppliers
*• Dairy equipment supply dealers
*• Medical and dental suppliers
* Feed, seed and fertilizer dealers
* Hotel and restaurant suppliers
* Janitorial supply dealers
*• Paint dealers
* Pest control operations
*• Swimming pool, spa and waterbed dealers
* Retail and wholesale grocers
*• Lawn and garden supply dealers
> Retail outlets (e.g., Wal-Mart, K-Mart, etc.)
Additional leads to new sources of non-registered pesticides
include the following:
* Dealers (question dealer regarding others in the same
business).
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-18
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FIFRA Inspection Manual, July 2002
*• Local newspaper advertisements.
* Trade journals.
*• Yellow Pages telephone directories.
*• Information from State officials.
*• E-Commerce (sale on internet).
Marketplace Inspections
Potential Inspection Sites*
*• Animal health and veterinarian suppliers
* Barber and beauty supply dealers
*• Dairy equipment and supply dealers
* Feed, seed, and fertilizer dealers
* Janitorial supply dealers
* Pest control operators
* Wholesale grocers
*• Chemical suppliers
*• Chicken hatcheries
*• Medical and dental suppliers
* Hotel and restaurant suppliers
*• Paint dealers
* Pool, spa, and waterbed dealers
*• Lawn and garden supply dealers
*Not an inclusive list.
Entry
Present credentials and issue a Notice of Inspection to the most
responsible person present at the time of the inspection. If a
violation is suspected or if the inspection is not routine, the reason
for inspection and the suspected violation must be noted in writing
on the Notice of Inspection.
Persons Interviewed
> Name, address, and telephone number of facility.
*• Name, title, and telephone number of person(s) interviewed.
Description of Activity
Brief description of facility or individual activities, i.e. janitorial
supply dealer, pest control company, wholesale grocer, etc.
Label/Labeling Review
A thorough label review of pesticides being offered for sale or
distribution should be conducted to verify compliance with the
registration requirements and to identify instances of suspected
misbranding. Also document collateral labeling and literature such
as shelf liners, advertising material, flyers, etc.
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-19
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FIFRA Inspection Manual, July 2002
Note: Antimicrobials, treated articles, pet products, swimming pool
and pond products, paints, etc. are excellent products for review in
addition to typical farm, home, and garden pesticides.
Pesticide Product Review
* Note any products requiring child resistant packaging
* Note any canceled/suspended pesticides
* Observe products for leaking containers
* Note security/safety of restricted use pesticides in storage
Shipping Records
Suspected violations should be documented by collecting shipping
records to document the suspected violative product's movement
in the channels of trade. Recognizing that shipping records are
sometimes difficult to obtain in the marketplace, make every effort
to document at least five separate shipments/sales or collect
records documenting five separate days of shipments or sales,
whichever reveals the greater number. Inspectors are encouraged
to obtain computer-generated records. If records are unavailable,
document this fact in a statement signed by the agent-in-charge
with an explanation of where the records are and how they can be
obtained.
Bulk Repackager Inspections
With the growing trend for pesticides to be shipped and held in
bulk quantities (more than 55 gallons liquid or 100 pounds solid),
uniform inspection procedures are needed for facilities that handle
bulk pesticides. Most bulk establishments handle agricultural
herbicides; however, other industries use bulk quantities of
chemicals such as sodium hypochlorite and quaternary ammonium
disinfectants. In some cases (certain herbicides) a bulk amount
could be a very small quantity.
Objectives
The primary objectives of bulk repackaging inspections are to (1)
ensure industry awareness of its obligations for packaging, labeling
and recordkeeping, (2) document violations, and (3) verify
compliance with annual production reporting requirements of
section 7 of FIFRA.
Bulk Facilities Inspections
If the facility receives bulk quantities of pesticides intended to be
dispensed into a customer's spray tank for subsequent use, the
inspection should proceed as a marketplace inspection. If the
facility receives pesticides in bulk quantities (under contract to the
basic registrant) and subsequently repackages the product (without
alteration) into other labeled tanks for the purpose of distribution,
the inspection should proceed as a producer establishment
inspection.
Inspector's Obligations and Procedures
The inspector should seek the most responsible individual available
at the inspection site and present his/her credentials to that person.
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-20
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FIFRA Inspection Manual, July 2002
The owner, operator, or agent in charge should then be issued a
Notice of Inspection (EPA Form 3540-2), stating the reason for
inspection and any suspected violations. The inspector should
explain the purpose of the inspection and the statutory authority
for such an inspection.
Particular items to check at a bulk site include, but may not be
limited to, the following:
*• Labels on all bulk tanks.
*• If the firm is repackaging, verify the maintenance of a
manufacturing contract between the firm and the basic
registrant.
*• Conduct a label review in accordance with Exhibit 7-10.
* Sample, as appropriate, in accordance with established
procedures in this chapter.
*• Review sales invoices to verify transfer is occurring in bulk
quantities.
*• If the firm is a repackager, verify the status of the firm's
establishment registration.
PREPARING THE INSPECTION REPORTS
Establishment Inspection Report
A narrative report (Establishment Inspection Report, EIR) should
be completed for each producing establishment inspected. The
purpose of the narrative report is to capture sufficient information
to portray accurately what is taking place at the establishment with
regard to pesticide production. The format of the report may vary,
but the content should include at a minimum the information listed
below:
*• EPA Establishment Number
*• The name, address, and telephone numbers of the firm
*• Names and titles of principal officers, partners, or owners
* Related firms
*• Persons interviewed (name, title, phone number, and
responsibility.
* Guarantees and labeling agreements
*• Imports and Exports
*• Manufacturing/batch codes
*• Number of pesticides registered and number of pesticides
produced.
* Consignees for pesticides produced but not available for
sampling.
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-21
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FIFRA Inspection Manual, July 2002
Marketplace Inspection Report
This report is acceptable for routine nonviolative inspections.
Where for-cause inspections were conducted and/or suspected,
and violative samples were collected, a brief narrative report in
memorandum form should also be completed.
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-22
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FIFRA Inspection Manual, July 2002
Exhibit 7-1: Notice of Inspection (EPA Form 3540-2)
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
NOTICE OF INSPECTION
ADDRESS (EPA Regional Office)
HOUR
A.M.
P. M
NAME OF INDIVIDUAL
TITLE
FIRM NAME
FIRM ADDRESS (Number, Straat, City, State, and ZIP Code)
SIGNATURE OF EPA EMPLOYEE
TITLE
REASON FOR INSPECTION
FOR THE PURPOSE OF INSPECTING AND OBTAINING SAMPLES OF ANY PESTICIDES OR DEVICES PACKAGED, LABELED, AND
RELEASED FOR SHIPMENT, AND SAMPLES OF ANY CONTAINERS OR LABELING FOR SUCH PESTICIDES OR DEVICES. IN
PLACES WHERE THE PESTICIDES OR DEVICES ARE HELD FOR DISTRIBUTION OR SALE (Sec. 9(a) and T2(a){2)(B)l; AND FOR
THE PURPOSE OF INSPECTING AND OBTAINING COPIES OF THOSE RECORDS SPECIFIED IN SECTION B AND 4O CFR PART
169. (Sac. B and 12(»)(2)(B)).
VIOLATION SUSPECTED:
Section 8, 9(a) and 12{a)(2)(B) of the Federal Insecticide, Fungicide, and Rodanticide Act, as amended (7 U.S.C. 136 et seq.) are quoted
on the reverse of this form.
EPA FORM 3S4O-2 (Rev. O1-Q1)
PREVIOUS EDITION MAY BE USED
UNTIL SUPPLY IS EXHAUSTED
1. Original - ESTABLISHMENT COPY
2. SAMPLE RECORD COPY
3. REGION COPY
4. INSPECTOR'S COPY
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-23
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FIFRA Inspection Manual, July 2002
Sec. 8. [136f| Books and Records.
(b) Inspection.
For the purposes of enforcing the provisions of this Act, any producer, distributor, carrier, dealer, or any other person who sells or
offers for sale, delivers or offers for delivery any pesticide or device subject to this Act, shall, upon request of any officer or employee
of the Environmental Protection Agency or of any State or political subdivision, duly designated by the Administrator, furnish or
permit such person at all reasonable times to have access to, and to copy:
(1) all records showing the delivery, movement, or holding of such pesticide or device, including the quantity, the date of
shipment and receipt, and the name of the consignor and consignee;
(2) in the event of the inability of any person to produce records containing such information, all other records and
information relating to such delivery, movement, or holding of the pesticide or device. Any inspection with respect to any
records and information referred to in this subsection shall not extend to financial data, sales data other than shipment data,
pricing data, personnel data, and research data (other than data relating to registered pesticides or to a pesticide for which
an application for registration has been filed). Before undertaking an inspection under this subsection, the officer or
employee must present to the owner, operator, or agent in charge of the establishment or other place where pesticides or
devices are held for distribution or sale, appropriate credentials and a written statement as to the reason for the inspection,
including a statement as to whether a violation of the law is suspected. If no violation is suspected, an alternate and
sufficient reason shall be given in writing. Each such inspection shall be commenced and completed with reasonable
promptness.
Sec. 9. [136g] Inspection of Establishments, Etc.
(a) In General.
(1) For purposes of enforcing the provisions of this Act, officers or employees of the Environmental Protection Agency or
of any State duly designated by the Administrator are authorized to enter at reasonable times
(A) any establishment or other place where pesticides or devices are held for distribution or sale for the purpose
of inspecting and obtaining samples of any pesticides or devices, packaged, labeled, and released for shipment,
and samples of any containers or labeling for such pesticides or devices; or
(B) any place where there is being held any pesticide the registration of which has been suspended or canceled
for the purpose of determining compliance with section 19.
(2) Before undertaking such inspection, the officers or employees must present to the owner, operator, or agent in charge of
the establishment or other place where pesticides or devices are held for distribution or sale, appropriate credentials and a
written statement as to the reason for the inspection, including a statement as to whether a violation of the law is suspected.
If no violation is suspected, an alternate and sufficient reason shall be given in writing. Each such inspection shall be
commenced and completed with reasonable promptness. If the officer or employee obtains any samples, prior to leaving the
premises, the officer or employee shall give to the owner, operator, or agent in charge a receipt describing the samples
obtained and, if requested, a portion of each such sample equal in volume or weight to the portion retained. If an analysis is
made of such samples, a copy of the results of such analysis shall be furnished promptly to the owner, operator, or agent in
charge.
Sec. 12. [136j] Unlawful Acts.
(a) In General.
(2) It shall be unlawful for any person —
(A) to detach, alter, deface, or destroy, in whole or in part, any labeling required under this Act
(B) to refuse to —
(i) prepare, maintain, or submit any records required by or under section 5, 7, 8, 11, or 19;
(ii) submit any reports required by or under section 5, 6, 7, 8, 11 or 19;
(iii) allow any entry, inspection, copying of records, or sampling authorized by this Act.
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-24
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FIFRA Inspection Manual, July 2002
Exhibit 7-2: Producer Establishment Inspection Checklist
(May be used as an inspection tool.)
FIRM INSPECTED:
EPA EST. NO:
AUTHORIZED REP. ADDRESS:
CITY: STATE: ZIP: TELEPHONE NUMBER:
CREDENTIALS PRESENTED?
NOTICE OF INSPECTION ISSUED?
REASON FOR INSPECTION?
VIOLATION SUSPECTED?
Names, Titles, and Telephone Numbers of Principal
Officers, Partners, Owners:
Related Firms and Addresses of Said Companies:
PESTICIDE LABEL. LABELING. AND PACKAGING INSPECTION
PESTICIDES PACKAGED, LABELED AND RELEASED FOR SHIPMENT / Section 9(a)
1. Brand Name(s):
2. EPA Registration Number(s):
3. Label and Labeling Review / 40 CFR Part 156:
Child-Resistant Packaging Requirements for Each Pesticide Product Packaged,
Labeled and Released For Shipment / 40 CFR Part 157
1. Criteria Requiring Child-Resistant Packaging:
2. Unit Packaging:
RECORDS RETENTION REQUIREMENTS FOR PESTICIDE PRODUCTION
RECORDS OF PRODUCTION OF PESTICIDES / 40 CFR Part 169 2(a)
1. Brand Name:
2. EPA Registration Number / Experimental-Use Permit Number:
3. Amounts Produced per Batch:
4. Batch Identification:
5. Length of Retention of Records:
RECORDS OF PRODUCTION OF DEVICES / 40 CFR Part 169 2(b)
1. Brand Name:
2. Quantities of Device(s) Produced:
RECORDS OF RECEIPT OF PESTICIDES AND ACTIVE INGREDIENTS / 40 CFR Part 169 2(c)
1. Brand Name of Pesticide, or Common or Chemical Name
of Active Ingredient:
2. Name and Address of Shipper:
3. Name of Delivering Carrier:
4. Date Received by Establishment:
5. Quantities Received:
6. Retention of Records:
RECORDS OF SHIPMENT OF PESTICIDES AND ACTIVE INGREDIENTS / 40 CFR Part
169.2(d)
1. Brand Name of Pesticide, or Common or Chemical Name
of Active Ingredient:
2. Name and Address of Consignee:
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-25
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FIFRA Inspection Manual, July 2002
3. Where the Pesticide Under a Section 5 Permit, Section 18
Exemption, or Section 24(c) Registration is/was Produced:
4. Name of Originating Carrier:
5. Date Shipped or Delivered for Shipment:
6. Quantities Shipped or Delivered for Shipment:
7. Retention of Records:
OTHER RECORDS / 40 CFR Part 169.2
1. Inventory Records:
2. Copies of All Domestic Advertising of The Restricted Uses of
Any Pesticide Registered for Restricted Use:
Retention of Records:
3. Copies of Guarantees Given Pursuant to Section 12(b)(l)
Retention of Records:
4. Records on The Method of Disposal, Dates of Disposal, Location
of The Disposal Site(s), and The Types and Amounts of Pesticides
or Active Ingredients Disposed of by the Producer/Contractor
FIFRA/RCRA Records:
Retention of Records:
RECORDS RETENTION REQUIREMENTS OF CHILD RESISTANT PACKAGING / 40 CFR
Part 157.36
1. Description of the Packaging for Each Registration:
2. Certification Statement for Each Registration:
3. Test Data Verification of Child Resistance
for Each Registration:
4. Records Verifying That The Packaging Meets
The Compatibility and Durability Standards:
RECORDS REQUIREMENTS UNDER THE PESTICIDE EXPORT POLICY / 40 CFR Part 168,
Subpart D
1. Confidential Statement of Formula for Pesticides
Not Registered Under FIFRA:
2. Specifications or Directions of
the Foreign Purchaser:
3. Bilingual Labeling and Other Required Labeling:
4. Foreign Purchaser Acknowledgement Statements:
5. Establishment / Foreign Purchaser Contracts:
RECORDS REPORTING REQUIREMENTS FOR REGISTRANTS/PESTICIDE
PRODUCING ESTABLISHMENTS
1. Application for Amended Registration / 40 CFR Part 152.44:
2. Modifications to Registration Not Requiring
Amended Applications / 40 CFR Part 152.46:
3. Currency of Address of Record and Authorized Agent
40 CFR Part 152.122:
4. Submission of Information Pertaining to Adverse Effects
Section 6(a)(2), 40 CFR Part 152.125, and Part 153, Subpart D:
5. Supplemental Distribution / 40 CFR Part 152.132:
6. Transfer of Registration(s) / 40 CFR Part 152.135:
7. Initial Production Reports / Section 7(c)
and 40 CFR Part 167:
8. Annual Production Reports / Section 7(c):
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-26
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FIFRA Inspection Manual, July 2002
and 40 CFR Part 167:
9. Notification of Stored Pesticides With Canceled or
Suspended Registrations / Section 6(g):
POLICY ON BULK PESTICIDE REPACKAGING
1. Bulk Repackaging / Contract Bulk Repackaging Agreements:
2. Complete End-Use Labeling / Bulk Containers:
3. Complete End-Use Labeling / Mini-Bulk Containers:
ADDITIONAL INFORMATION
1. Private Labeling by a Contractor:
2. Private Labeling Under Contract for
Another Registrant/Distributor:
"Contract Manufacturing Agreements:
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-27
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FIFRA Inspection Manual, July 2002
Exhibit 7-3: Marketplace Inspection Checklist
(May be used as an inspection tool.)
FIRM INSPECTED: _
AUTHORIZED REP.:
ADDRESS:
CITY: STATE: ZIP:.
TELEPHONE NUMBER:
CREDENTIALS PRESENTED:
NOTICE OF INSPECTION ISSUED:
REASON FOR INSPECTION:
VIOLATION SUSPECTED: .
* Names, Tides, and Telephone Numbers of Principal
Officers, Partners, Owners:
* Related Firms and Addresses of Said Companies:
PESTICIDE LABEL. LABELING. AND PACKAGING INSPECTION
PESTICIDES PACKAGED, LABELED AND RELEASED FOR SHIPMENT / Section 9 (a)
1. Brand Name(s):
2. EPA Registration Number(s):
3. Label and Labeling Review / 40 CFR Part 156:
Child-Resistant Packaging Requirements for Each Pesticide Product Packaged,
Labeled and Distributed-Sold / 40 CFR Part 157
1. Criteria Requiring Child-Resistant Packaging:
2. Unit Packaging:
RECORDS RETENTION REQUIREMENTS FOR PESTICIDE PRODUCTION
RECORDS OF RECEIPT OF PESTICIDES AND ACTIVE INGREDIENTS / 40 CFR Part
169.3
1. Brand Name of Pesticide, or Common or Chemical Name
of Active Ingredient:
2. Name and Address of Shipper/Consignor:
3. Name of Delivering Carrier:
4. Date Shipped to the Establishment:
5. Date Received by Establishment:
6. Quantities Received:
RECORDS OF SHIPMENT OF PESTICIDES AND ACTIVE INGREDIENTS / 40 CFR
Part 169.3
1. Brand Name of Pesticide, or Common or Chemical Name
of Active Ingredient:
2. Name and Address of Consignee:
3. Where the Pesticide Under a Section 5 Permit, Section 18
Exemption, or Section 24(c) Registration is/was Produced:
4. Name of Originating Carrier:
5. Date Shipped or Delivered for Shipment:
6. Quantities Shipped or Delivered for Shipment:
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-28
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FIFRA Inspection Manual, July 2002
RECORDS OF THE SALE OF RESTRICTED USE PESTICIDES / 40 CFR Part 171.11(g)
1. The Name and Address of the person to whom the RUP was
sold to:
2. The certification number of the person:
3. The State (or other governmental unit) that issued the certification:
4. The expiration date of the certification:
5. The categories in which the applicator is certified:
6. The Brand Name, EPA Registration Number of the RUP:
7. The quantity of the RUP made available:.
8. The date of the transaction:
9. The period of Record Retention:
OTHER RECORDS
1. Copies of All Domestic Advertising of Pesticide
[40 CFR Part 168.22]:
Copies of Guarantees Given Pursuant to Section 12(b)(l):
RECORDS REQUIREMENTS UNDER THE PESTICIDE EXPORT POLICY / 40 CFR
168, Subpart D
1. Confidential Statement of Formula for Pesticides
Not Registered Under FIFRA:
2. Specifications or Directions of
Foreign Purchaser:
3. Bilingual Labeling and Other Required Labeling:
4. Foreign Purchaser Acknowledgment Statements:
5. Establishment / Foreign Purchaser Contracts:
ADDITIONAL INFORM A TION
1. Supplemental Registration with A Registrant:
2. Private Labeling Under Contract by a Contractor:
*Contract Manufacturing Agreements'.
3. Notification of Stored Pesticides With Canceled or
Suspended Registrations / Section
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-29
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FIFRA Inspection Manual, July 2002
Exhibit 7-4: Receipt for Samples (EPA Form 3540-3)
UNITED STATES
,toW4, ENVIRONMENTAL PROTECTION AGENCY
? Q \
\£&£J RECEIPT FOR SAMPLES
*•"***'
NAME OF INDIVIDUAL TH
FIRM NAME FIF
SAMPLE NUMBERS
ADDRESS (EPA Regional Office)
DATE
-LE
M ADDRESS (Number, Street, City. State, and ZIP Code)
SAMPLES COLLECTED /Describe fully. List Registration, Lot, Batch, Model, Serial Numbers, and other positive identification)
The following samples were collected by the U.S. Environmental Protection Agency and receipt is hereby acknowledged
pursuant to Section 9(a) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. 136 g). This
section is quoted on the reverse of this form.
ACKNOWLEDGEMENT OF PRODUCER/REGISTRANT
The undersigned acknowledges thai the samples shown above were
labeled, and released for shipment.
SIGNATURE (Owner, Operator, or Agent} TP
I — [DUPLICATE SAMPLES 1 — 1 DUPLICATE SAMPLES SA
1 — (REQUESTED AND PROVIDED 1 — 1 NOT REQUESTED
obtained from pesticides or devices that were packaged.
rLE (Owner, Operator, or Agent)
MPLES WERE rj PURCHASED FJ BORROWED
AMOUNT PAID FOR SAMPLES
$
LJCASH LJ VOUCHER I_J TO BE BILLED | | NO CHARGE
NAME OF COLECTOR (print or type) TITLE OF COLLECTOR
SIGNATURE OF COLLECTOR
EPA FORM 3S40-3 (Rev. O1-O1)
PREVIOUS EDITION MAY BE USED
UNTIL SUPPLY IS EXHAUSTED
1. Original - ESTABLISHMENT COPY
2. EIR COPY
3. SAMPLE RECORD COPY
4, COLLECTOR'S COPY
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-30
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FIFRA Inspection Manual, July 2002
Sec. 9. [136g] Inspection of Establishments, Etc
(a) In General.
(1) For purposes of enforcing the provisions of this Act, officers or employees of the Environmental Protection Agency or of any State
duly designated by the Administrator are authorized to enter at reasonable times:
(A) any establishment or other place where pesticides or devices are held for distribution or sale for the purpose of
inspecting and obtaining samples of any pesticides or devices, packaged, labeled, and released for shipment, and samples
of any containers or labeling for such pesticides or devices.
(B) any place where there is being held any pesticide the registration of which has been suspended or canceled for the
purpose of determining compliance with section 19.
(2) Before undertaking such inspection, the officers or employees must present to the owner, operator, or agent in charge of the
establishment or other place where pesticides or devices are held for distribution or sale, appropriate credentials and a written
statement as to the reason for the inspection, including a statement as to whether a violation of the law is suspected. If no violation is
suspected, an alternate and sufficient reason shall be given in writing. Each such inspection shall be commenced and completed with
reasonable promptness. If the officer or employee obtains any samples, prior to leaving the premises, the officer or employee shall
give to the owner, operator, or agent in charge a receipt describing the samples obtained and, if requested, a portion of each such
sample equal in volume or weight to the portion retained. If an analysis is made of such samples, a copy of the results of such analysis
shall be furnished promptly to the owner, operator, or agent in charge.
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-31
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FIFRA Inspection Manual, July 2002
Exhibit 7-5: Report on Establishment Inspection to
Determine Compliance with FIFRA
Report on Establishment Inspection
to Determine Compliance
with FIFRA Section
Establishment Name
Street Address
[Mailing Address]
City, State Zip Code
Date of Inspection
Month Day, Year
Performed by:
U.S. Environmental Protection Agency
Branch
Address
City, State Zip Code
FIFRA Establishment Inspection Report
[Inspection No. 01FIFRA ]
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-32
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FIFRA Inspection Manual, July 2002
I. COMPANY INFORMATION
a. Company Name:
b. Establishment Registration Number:
c. Responsible Official:
d. Type of Ownership:
II. DATE OF INSPECTION
III. PARTICIPANTS
Company
U.S. EPA
IV. OBJECTIVES
To inspect/investigate ... the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA).
V COMPANY BACKGROUND
VI. INSPECTION SUMMARY
A. Opening Conference
B. Inspection Observations and Sample Collection
C. Closing Conference
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-33
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FIFRA Inspection Manual, July 2002
VII. ATTACHMENTS
1. Establishment Inspection Report Form
2. FIFRA Notice of Inspection
3. FIFRA Receipt for Samples
4. EPA Chain of Custody
5. Statements
6. Labeling
7. Sample Collection Report
8. Sample Reports of Analysis
9. Photographs
(Inspector's Name), (Title) Date
Pesticides and Toxics Enforcement Section
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-34
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FIFRA Inspection Manual, July 2002
ENFORCEMENT SENSITIVE
FIFRA Establishment Inspection
Compliance /Non-Compliance Based on Findings and Observations
Company: Name
Street Address
[Mailing Address]
City, State Zip Code
Inspector: (Inspector Name), (Title)
Date of Inspection: Month Day, Year
Inspection/Investigation Findings and Observations:
Based on the information received during ...
(Inspector's Name), (Title) Date
Pesticides and Toxics Enforcement Section
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-35
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Exhibit 7-6: Application for Registration of Pesticide-Producing Establishments
(EPA Form 3540-8)
^ PP^V United States FORM APPROVED
\SCMf\ Environmental Protection Agency OMB NO 20/0-00/8
Washington, DC 20460
Application for Registration of Pesticide-Producing and Device-Producing
Establishments
1. Company Name
2. Company Name (if different from 1)
Company Headquarters Location j
3. Street Address
4. City 5. State 6. Zip
or County Code
i Company Headquarters Mailing Address j
7. Street or PO Box
Address
8. City 9. State 10. Zip
or Country Code
11. EPA Company
Number
12. Company D & B No.
Appropriate
Ownership code
1 -Individual
2 - Partnership
3 - Cooperative Associ;
4 - Corporation
5 - Other
ition
14. State or Country
15. Date of Incorporation
(Month, Day, Year)
NAME, SITE LOCATION, and MAILING ADDRESS of EACH NEW PRODUCING ESTABLISHMENT !
16. Establishment Name EPA Est. No.
(EPA use only)
17. Establishment Site Address 18. City
21. Establishment Mailing Address 22. City
I 1 1 1 1 1 1 25. NAICS Code.
19. State or Country
23. State or Country
26. D & B No.
16. Establishment Name EPA Est. No.
(EPA use only)
17. Establishment Site Address 18. City
21. Establishment Mailing Address 22. City
I 1 1 1 1 1 1 25. NAICS Code.
19. State or Country
23. State or Country
26. D & B No.
16. Establishment Name EPA Est. No.
(EPA use only)
17. Establishment Site Address 18. City
21. Establishment Mailing Address 22. City
I 1 1 1 1 1 1 25. NAICS Code.
19. State or Country
23. State or Country
26. D & B No.
20. Zip
24. Zip
20. Zip
24. Zip
20. Zip
24. Zip
EPA
USE
27. NAME of Company 28. Telephone EPA Received date
29. E-mail Address 30. FAX Number USE Signature
31 . TITLE of Company Officer 32. Date Signed Region
33. SIGNATURE of Company Officer Review Date
EPA Form 3540-8 (Rev. 04-01) Previous editions are obsolete THIS IS PAGE
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-36
OF
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FIFRA Inspection Manual, July 2002
Exhibit 7-7: Instructions for Completing EPA Form 3540-8
United States Environmental Protection Agency
Instructions for Completing EPA Form 3540-8 (revised 04/2001)
APPLICATION: ESTABLISHMENT REGISTRATION
FOR PESTICIDE AND DEVICE PRODUCERS
Requirement: Section 7 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) provides that
no person shall produce any pesticide or any device in any state/territory unless the establishment in which
it is produced is registered with the US Environmental Protection Agency (EPA).
• • Please read all instructions before you begin to fill out EPA Form 3540-8.
IF YOU HAVE QUESTIONS REGARDING SECTION 7 REQUIREMENTS:
"Produce" is defined by FIFRA and at 40 CFR 167.3. You "produce" a pesticide, active
ingredient, or device if you do any of the following activities:
• "manufacture • "propagate • "repackage • "otherwise
• "prepare • "process • "label change the
• "compound • "package • "relabel container
Note: Establishments that do only custom blending do not need to be registered. Establishments
which report production of other products do not need to report their custom blending activities.
Custom blending is defined at 40 CFR 167.
• • Domestic establishments: Contact your Regional Office. (See page 4.)
• • Foreign establishments: Contact the Washington, DC Office. (See page 4.)
Name/Address Changes: Domestic establishments must provide name and address changes to the US
EPA Regional Office (see page 4) where the company headquarters is located. Foreign establishments
must provide name and address changes to the US EPA Washington, DC Office (see page 4). Information
must be supplied in writing within 30 days of the change.
Complying with the Registration Requirement: To comply with this requirement, a responsible officer
of the company must complete EPA Form 3540-8 and submit it to the US EPA office with jurisdiction over
the state/territory in which the company headquarters is located (see page 4). Foreign companies must
submit the Form to the US EPA Washington, DC office (see page 4). Production activity cannot
commence before a number has been assigned. You will be notified in writing after the establishment
number(s) is assigned.
Public Reporting Burden: For this information, time required is estimated to average 18 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering and
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-37
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FIFRA Inspection Manual, July 2002
maintaining the data needed, and completing the reviewing and collection of information. Send comments
regarding this burden estimate or any other aspect of this information collection, including suggestions for
reducing this burden, to Director, OEI/OIC Collection Strategies Division (2823), US Environmental
Protection Agency, 1200 Pennsylvania Avenue, NW, Washington, DC 20460-0001, and to the Paperwork
Reduction Project, Office of Information and Regulatory Management Affairs, Office of Management and
Budget, 725 17th Street, NW, Washington, DC 20503 (Attention: Desk Officer for US EPA).
ITEMS TO BE COMPLETED ON EPA FORM 3540-8
Please print or type.
1. Company Name. Enter the complete name of the company submitting the application.
2. Company Name (if different from item 1). Enter Agent Name, if applicable.
3-6. Company Headquarters Location. Enter the physical street or route location (DO NOT
use a P.O. Box) of the home office or headquarters of the applicant company.
7-10. Company Headquarters Mailing Address. Complete if different from items 3-6. Foreign
Companies must use an agent residing in the United States to act for them. Enter the US mailing
address of the agent in items 7-10.
NOTE. Correspondence to companies with registered establishments is sent to the company
mailing address, e.g., the required annual production reports (EPA Form 3540-16) are mailed to this
address and not the individual establishment mailing address.
11. EPA Company Number. Enter the EPA Company number. Leave blank if one has not yet been
assigned.
12. Company D & B No. Enter the Dun and Bradstreet number of the company, if available.
13. Appropriate Ownership Code. Enter the code (1-5) which describes the type of ownership under
which the company operates.
If the ownership code in Item 13 is number 4 (Corporation), complete Items 14 and 15.
14. State or Country of Incorporation. Enter the two-letter State code or three-letter country code.
Country codes are on page 5.
15. Date of Incorporation. Enter the month, day, and year of incorporation, registration, or license to
do business.
Items 16-26: Each EPA Form 3540-8 has space for information for three new producing establishments.
Items 16 through 26 are repeated. Fill in the second and third sets of these items only if applying for more
than one establishment location.
If more space is needed (more than three establishments), check "continued on attached sheet" and
reproduce the form. Number the original and attached sheets as "Page of ". Sign each page.
16. Establishment Name. Enter the name of the establishment that will produce pesticide products
and/or devices. The establishment MUST BE a wholly-owned subsidiary of the parent company.
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-38
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FIFRA Inspection Manual, July 2002
EPA Est. No. (Establishment Number). Leave this item blank. The US EPA will assign a
number. Please refer to the Questions and Answers on Page 6 for information about Establishment
Numbers.
17-20. Establishment Site Address. Enter the physical street or route location, city, State, and zip code.
DO NOT use a P.O. Box. For foreign countries, use abbreviations shown on page 5 for item 19.
21-24. Establishment Mailing Address. Enter if different from boxes 17-20.
25. NAICS Codes. Leave this item blank. The Agency is not currently collecting this information
for Pesticide-Producing and Device-Producing Establishments.
26. Establishment D&B Number. Enter only if different from the Company D&B No. (box 12).
27. Name of Company Officer. The company officer is a person who can obligate the company to the
requirements of Section 7. Please print or type the name.
28. Telephone Number. This item must be completed for the Application to be processed.
29. E-mail Address (Optional)
30. FAX Number of Company Headquarters (Optional)
31. Title of Company Officer. This item must be completed in order for the Application to be
processed.
32. Date Signed. This item must be completed in order for the Application to be processed.
33. Signature of Company Officer. Unsigned Applications will not be processed.
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-39
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FIFRA Inspection Manual, July 2002
Upon receipt of EPA Form 3540-8, each Pesticide-Producing and Device-Producing
Establishment will be assigned a unique number. The US EPA will notify the company
of the assigned establishment number. This number must be on labels of products
(pesticides and devices) produced at that facility.
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-40
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FIFRA Inspection Manual, July 2002
SEND APPLICATIONS FOR DOMESTIC ESTABLISHMENTS TO:
the US EPA Regional Office having Jurisdiction over the State/Territory
in which the Company Headquarters is Located.
US Environmental Protection Agency Regional Offices and State/Territory Abbreviations
US EPA Regional Offices
US EPA Region I
Lee Weller
Pesticides Section (SEA)
J.F. Kennedy Fed. Bldg.
Boston, MA 02203-2211
Telephone 617-565-9055
US EPA Region II
David Salkie
Pesticides Team (MS-500)
Building 5
2890 Woodbridge Avenue
Edison, NJ 08837-3679
Telephone 732-321-6750
US EPA Region III
Kyla Townsend-Mclntyre
Pesticides Programs (3WC32)
1650 Arch Street
Philadelphia, PA 19103-2029
Telephone 215-814-2045
US EPA Region IV
Jacquelyn Wilkerson
AFC Pesticides Section (APTMD)
61 Forsyth Street, SW
Atlanta, GA 30303-3104
Telephone 404-562-9011
US EPA Region V
Gail Muffitt
PTES (DT-8J)
77 W.Jackson Blvd.
Chicago, IL 60604-3507
Telephone 312-886-6008
States/Terr.
Covered
CT,MA
ME,NH
RI,VT
NJ,NY
PR, VI
DE,DC
MD,PA
VA,WV
AL,FL
GA,KY
MS,NC
SC,TN
IL,IN
MI,MN
OH,WI
US EPA Regional Offices
US EPA Region VI
James Redd
Pesticides Section (6PD-P)
1445 Ross Avenue
Dallas, TX 75088-2733
Telephone 2 14-665-7560
US EPA Region VII
Lou Banks
Pesticides Branch (WWPD / PEST)
90 IN. 5th Street
Kansas City, KS 66101-2798
Telephone 913-551-7125
US EPA Region VIII
Cornelia Maes
Enforcement Division (ENF-PT)
999 18th Street, Suite 300
Denver, CO 80202-2466
Telephone 303-312-6049
US EPA Region IX
Glenda Dugan
Pesticides Section (CMD-4-3)
75 Hawthorne Street
San Francisco, CA 94105-3901
Telephone 415-744-1066
US EPA Region X
Eva Chun
Pesticides Unit (ECO-084)
1200 Sixth Avenue
Seattle, WA 98101-1128
Telephone 206-553-1970
States/Terr.
Covered
AR,LA
NM,OK
TX
IA,KS
MO,NB
CO,MT
ND, SD
UT,WY
AZ, CA,
HI,NV
AS,GU
AK,ID
OR,WA
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-41
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FIFRA Inspection Manual, July 2002
SEND APPLICATIONS FOR FOREIGN ESTABLISHMENTS TO:
US Postal Service Mail Address
Carol L. Buckingham
US Environmental Protection Agency
Agriculture Division (2225A)
1200 Pennsylvania Ave., NW
Washington, DC 20460-0001 USA
Telephone: 202-260-5008
FOREIGN COUNTRY
Courier Delivery Address
Carol L. Buckingham (Room 6102)
US Environmental Protection Agency
Agriculture Division
1200 Pennsylvania Ave., NW
Washington, DC 20004 USA
E-mail: buckingham.carol@epa.gov
ABBREVIATIONS
COUNTRY
CODE
COUNTRY
CODE
ARGENTINA
AUSTRALIA
AUSTRIA
BARBADOS
BELGIUM
BRAZIL
BULGARIA
CANADA
CZECH REPUBLIC
CHILE
CHINA
COLOMBIA
COSTA RICA
DENMARK
DOMINICAN
REPUBLIC
ECUADOR
EL SALVADOR
FINLAND
FRANCE
GERMANY
ARC
AUS
AUT
BRB
BEL
BRA
BGR
CAN
CHK
CHL
CHN
COL
CRI
DNK
DOM
ECU
ELS
FIN
FRA
DEU
GUATEMALA
HAITI
HONG KONG
HUNGARY
INDIA
INDONESIA
IRELAND
ISRAEL
ITALY
JAMAICA
JAPAN
JORDAN
KENYA
LIECHTENSTEIN
MALAYSIA
MEXICO
MONACO
NETHERLANDS
NETHERLANDS
ANTILLES
NEW ZEALAND
GTM
HTI
HKG
HUN
IND
IDN
IRL
ISR
ITA
JAM
JPN
JOR
KEN
LIE
MYS
MEX
MCO
NLD
ANT
NZL
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-42
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FIFRA Inspection Manual, July 2002
NICARAGUA
NORWAY
PAKISTAN
PANAMA
PAPUA NEW GUINEA
PERU
PHILIPPINES
POLAND
PORTUGAL
REPUBLIC OF
KOREA
ROMANIA
RUSSIA
RWANDA
SCOTLAND
SINGAPORE
SLOVENIA
SOUTH AFRICA
SOUTH VIETNAM
SPAIN
NIC
NOR
PAK
PAN
PNG
PER
PHL
POL
PRT
KOR
ROM
RUS
RWA
SCT
SGP
SLO
ZAF
SVN
ESP
SWEDEN
SWITZERLAND
TAIWAN
TANZANIA
THAILAND
TRINIDAD AND
TOBAGO
TURKEY
UGANDA
UKRAINE
UNITED ARAB
EMIRATES
UNITED KINGDOM
URUGUAY
YUGOSLAVIA
VENEZUELA
SWE
CHE
TWN
TZA
THA
TTO
TUR
UGA
URK
UAE
GBR
URY
YUG
VEN
Please contact US EPA Headquarters,
202-564-5008, if you do not
see the appropriate country code here
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-43
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FIFRA Inspection Manual, July 2002
Exhibit 7-8: Pesticides Report for Pesticide-Producing Establishments
(EPA Form 3540-16)
United States FORM APPROVED
1O|.CPA Environmental Protection Agency OMB NO 2070-0073
\rt-ir* Washington, DC 20460
Pesticide Report for Pesticide-Producing and Device-Producing Establishments
Section 7, Federal Insecticide, Fungicide, and Rodenticide Act, (7 U.S.C. 136e)
Note: Read all instructions before completing. Production and distribution/sales volumes information reported on this form is treated as
business confidential.
1. Mailing Address
2. City
3. State or Country
5. Name of Establishment Officer
6. Title
14. Telephone Number
4. Zip Code
7. Date (Mo., Day, Year)
8. EPA Est. No.
9. Establishment Name
10. Site Address
11. City
12. State or Country
16.
13. Zip
15. Signature of Establishment Officer
PESTICIDE PRODUCTION INFORMATION
17. Product Code (If "4" attach chemical formulation per I I
instructions) | |
19. Product Name
18. EPA Product Registration Number
21. Product Type I I 22. Market Sold To I I 23. Use Classification I I 24. Unit
20. Product I I I I
of measure: I I
25. Amount Produced/Repackaged/Relabeled Last Year [2000]
26. Amount Sold/Distributed Last Year - US [2000]
27. Amount Sold/Distributed Last Year - Foreign [2000]
28. Amount To Be Produced/Repackaged/Relabeled This Year [2001]
17. Product Code (If "4" attach chemical formulation per I I
instructions) | |
19. Product Name
18. EPA Product Registration Number
21. Product Type I I 22. Market Sold To I I 23. Use Classification I I 24. Unit
20. Product I I I I
of measure: I I
25. Amount Produced/Repackaged/Relabeled Last Year [2000]
26. Amount Sold/Distributed Last Year - US [2000]
27. Amount Sold/Distributed Last Year - Foreign [2000]
98 flmnimt TA Ro PrnHiiroH/RonnrknnoH/RolnholoH This Yonr [20011
17. Product Code (If "4" attach chemical formulation per I I
instructions) | |
19. Product Name
18. EPA Product Registration Number
21. Product Type I I 22. Market Sold To I I 23. Use Classification I I 24. Unit
20. Product I I I I
of measure: I I
d G=Gallons I I
25. Amount Produced/Repackaged/Relabeled Last Year [2000]
26. Amount Sold/Distributed Last Year - US [2000]
27. Amount Sold/Distributed Last Year - Foreign [2000]
28. Amount To Be Produced/Repackaged/Relabeled This Year [2001 ]
CONTINUED ON ATTACHED SHEET ( ) THIS IS PAGE OF
EPA Reviewer
EPA Office Postmark Date or C
ate Reviewed 29. Reporting
EPA Form 3540-16 (Rev. 09-00) Previous editions are obsolete.
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-44
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FIFRA Inspection Manual, July 2002
Exhibit 7-9: Instructions for Completing EPA Form 3540-16
United States Environmental Protection Agency
Instructions for Completing EPA Form 3540-16 (revised 9/00)
Pesticide Report for Pesticide-Producing and
Device-Producing Establishments for Reporting Year 2000
Electronic copies of this Form can be downloaded from http://www.epa.gov/region4/air/pesticides/pestreport.htm
A REPORT MUST BE SUBMITTED ON OR BEFORE MARCH 1, 2001, EVEN IF THERE HAS BEEN NO PRODUCTION.
Section 7 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (92 Stat. 829, 7 U.S.C. 136e),
requires all registered pesticide-producing establishments to submit an initial report to the U S Environmental
Protection Agency (EPA) 30 days after receipt of a notification of registration and an annual report thereafter.
FAILURE TO FILE the annual or initial pesticide production report is an unlawful act and may result in the
termination of the establishment's registration, civil penalties up to a maximum of $5,500 per required filing,
and/or criminal penalties. It is unlawful to knowingly falsify all or part of any pesticide production information
reported on EPA Form 3540-16. (Section 12(a)(2)(M) of FIFRA, [136j]).
If you have questions regarding Section 7 requirements, contact your Regional office. See Page 1 .
(Foreign producers or their agents should contact the Washington, D.C. office. See Page 7.)
CHANGES TO EPA FORM 3540-16 THAT ARE NEW THIS YEAR
The address block of EPA Form 3540-1 6 has been revised so that the label provided can be
placed on the right side of the Form without covering other requested information. Previous
editions of the Form (dated prior to 9-00) are obsolete and should not be used.
This year we have provided a specific site (Item 1 6.) in which to write "No Production" for those
establishments which had no (zero) production/distribution.
WHAT TO REPORT
Each producer operating an establishment must submit the required report listing the types and
amounts of pesticides, active ingredients, or pesticide devices produced/repackaged/relabeled last year
(2000); the distribution/sales of pesticides, active ingredients, or pesticide devices last year (2000),
regardless of when the product was produced; and an estimate of the amount of pesticide, active
ingredient, or pesticide devices you expect to produce/repackage/relabel in 2001.
This information is used by the EPA's Office of Enforcement and Compliance Assurance and the Office
of Prevention, Pesticides, and Toxic Substances to support risk-benefit analysis, inspection,
compliance, and enforcement activities.
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-45
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FIFRA Inspection Manual, July 2002
THE DEFINITION OF "PRODUCE"
> As defined by FIFRA, "produce" means "to manufacture, prepare, compound, propagate,
or process any pesticide or device or active ingredient used in producing a pesticide."
> "Produce" is further defined at 40 CFR 167.3 to mean, "manufacture, prepare, propagate,
compound or process any pesticide, including any pesticide produced pursuant to Section
5 of the Act, any active ingredient or device, or to package, repackage, label, relabel, or
otherwise change the container of any pesticide or device."
Note: EPA Form 3540-16 has space for only three products. If you produce more than three
products, continuation sheets are required. Place the enclosed, self-adhesive label on the
Form, check the CONTINUED ON ATTACHED SHEET, and reproduce the Form.
Complete "THIS IS PAGE OF " on all pages.
Please type or print this report.
Round off production/sales/distribution quantities to the nearest whole number.
Items 1 -16. ESTABLISHMENT INFORMATION
1- 4. Enter the establishment's MAILING address information.
5- 6. Clearly PRINT the Establishment Officer's name and title.
7. Enter the DATE the report is signed.
8-13. Place the enclosed SITE address label for the Establishment over boxes 8 to 13.
Please correct any errors on the label.
14. f Enter the phone number.
15. £B SIGN the report Form.
16. New Item This Year: If there was NO production or distribution of active
ingredients, pesticides, or pesticide devices at the establishment in 2000, but
the company wants to keep the establishment registration active, write "No Produc-
tion" in Item 16. Your annual report is complete. Mail to the appropriate
address on Page 7.
If there was either production and/or distribution of products at the establish-
ment in 2000, please skip Item 16 and continue to Item 17.
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-46
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FIFRA Inspection Manual, July 2002
General Instructions for Product Information
If the establishment has closed during the year, or if company has decided that no active ingredient,
pesticide, or pesticide device "production'Vdistribution will occur in the future at that site, you may
request inactivation of the establishment at the end of the report (after entering any production/distribution
information for 2000) by writing "Inactivate establishment,"
For each pesticide product (including unregistered pesticides produced for export only), active
ingredient, or pesticide device that was produced/packaged/repackaged/labeled/relabeled or otherwise
changed, Items 17-28 must be completed. Include all EPA and State-registered pesticides (Special
Local Needs), technical materials or active ingredients, pesticides produced while registration is
pending, pesticides produced under Experimental Use Permits, and pesticides produced for export only.
If you produced products registered by other companies (contract manufacturing) at the
establishment, you must include those products in your producing establishment's report.
If you produce a pesticide under MULTIPLE DISTRIBUTOR LABELS [supplemental distributors
(40 CFR 152.132) with the same basic registration number], please do one of the following:
A. List each product sequentially but separately on the report. For example, if you produce
product 79001-3 for three distributor labels, list the product number (e.g., 79001-3-76157,
79001-3-77938, and 79001-3-78325) separately, reporting quantities produced for each label.
Please do not intersperse these products throughout the document.
OR
B. Report the product under the basic registration, and provide the total quantities for all
distributor labels in one set of Items 17-28. In block 19, write the name of the basic product
and the words "and supplementals." On a separate paper, provide a list of the supplemental
distributor company numbers and brand names for which you produced or distributed last year
(2000) and attach it to your report. (Note: provide registration numbers of ONLY those
supplementals which you produced/distributed last year.)
If you produce a pesticide under ALTERNATE BRAND NAMES for the same registration number,
Eg. 78376-1: XYZ's Ken-Bor for Pet Kennels, XYZ's Hospital Insect Control, and XYZ's HomeBor
for Roaches, please report as follows:
Item 17: 78376-1
Item 18: XYZ's Ken-Bor for Pet Kennels "& alternate brand names."
Items 25-28: Add the production/distribution amounts for all the alternate brand name products
and enter the total on these lines.
The Following Types of Transactions Should NOT Be Reported:
Receipt of a product into your Establishment for transfer/sale when no changes are made to the
container, formulation, or label. (This type of transaction does not meet the definition of "Production.")
Distribution of a product that is shipped from your supplier directly to your customer.
(The establishment where the product was produced is responsible for reporting that production.)
Products that you produced/repackaged/relabeled sold/distributed in previous years but did
not produce/repackage/relabel/sell/distribute in 2000. (That is, if Lines 25, 26, 27, & 28 are
all zero, do not include the product on the report.)
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-47
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FIFRA Inspection Manual, July 2002
ITEMS 17-18. Product Code and EPA Product Registration Number.
Enter "1" in Item 17 if the product is registered with the EPA. Enter the EPA Product Registration Number
(EPA Reg. No.) exactly as it appears on the product label in Item 18. (See above instructions for products
produced for multiple distributor labels).
Enter "2" in Item 17 if the product registration is pending. Enter the EPA File Symbol in Item 18.
Enter "3" in Item 17 if the product has an Experimental Use Permit. Enter the EPA Experimental Use Permit
number exactly as it appears on the product label in Item 18.
Enter "4" in Item 17 if the product is a pesticide device; leave Item IB blank.
Enter "4" in Item 17 if the product is a chemical and Product Codes 1, 2, 3, or 5 do not apply; leave Item 18
blank. For these products, attach a list of the chemical names of all ingredients in the product, both active and
inert; their common names; their CAS Registry numbers (if available), and the percentage, by weight, of each
ingredient (must total 100%). (To save paper, you may put formulations for multiple products on each sheet.)
Enter "5" in Item 17 if the product is a Special Local Need product (SEN), also known as a 24(c). Enter the
SLN registration number in Item 18. The format is: SEN - AA - xxxxxx, where AA is the state in which the
1 product is registered and xxxxxx is the product number (for example, SLN-CA-xxxxxx or SLN-IL-xxxxxx.)
ITEM 19. Enter the Product Name exactly as it appears on the product label. If the product was sold under
alternate brand names, list those in Item 19 as follows: Brand Name 1 "& alternate brand names."
ITEM 20. Product Classification. Enter the Number from the list below that best describes the product.
05 Algicide 02 Fungicide 06 Nematocide
11 Animal Repellent 04 Herbicide 07 Plant Regulator
10 Antifouling Paint 44 Herbicide-Fungicide 03 Rodenticide
08 Defoliant, Desiccant 01 Insecticide 14 Water Purifier-Point of Use
13 Device 21 Insecticide-Fungicide 15 Water Purifier-Small System
09 Disinfectant, Germicide, Sanitizer 16 Multi-Use Active Ingredient 12 Other Pesticides (includes insect re-
pellents such as DliliT)
ITEM 21. Product Type. Enter the Number that describes the type of product.
Enter "1" if the product was formulated at the establishment into a TECHNICAL MATERIAL or ACTIVE
INGREDIENT for Manufacturing Use Only. (This product is not suitable, nor is it labeled suitably, for
end-use applications).
Enter "2" if the product was formulated at the establishment into an END-USE BLEND. FORMULATION, or
CONCENTRATE. (This product is suitable and is labeled for end-use applications). Include those
products your establishment formulates, reformulates, or repackages from your own establishment's
manufacturing-use products or end-use products. Product Type 2 describes blending, dilution, or change in the
formulation of the product.
Enter "3" if the product was REPACKAGED or RELABELED. (This activity includes transferring a product
from its container and repackaging and relabeling the product into another. It also includes relabeling or
making changes to the label when the product remains in its original container, This activity does not include
any blending, dilution or change in the formulation of the product.)
Enter "4" if the product produced or repackaged was a pesticide DEVICE.
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-48
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FIFRA Inspection Manual, July 2002
ITEM 22. Market Sold To. Enter the Number that describes the market to which the pesticide was sold/distributed.
Domestic Establishments:
Enter "1" if all of the product was marketed in the United States.
Enter "2" if the product was both marketed in the United States and exported out of the United States.
Enter "3" if all of the product was exported out of the United States.
Foreign Establishments:
Enter "1" for products marketed in the United States.
Foreign establishments do NOT report products that were sold in countries other than the United States.
ITEM 23. Use Classification. Enter the Number that describes the use classification of the product.
Enter "1" if the product's label states RESTRICTED USE ONLY (to be applied by/under direct supervision of a certified applicator
only).
Enter "2" for all other pesticide products and for all pesticide devices.
ITEM 24. Unit of Measure. Enter the Unit that best describes how the product was packaged.
G = Gallons [liquid chemical product] P = Pounds [dry or solid chemical product]
L = Liters [liquid chemical product] K = Kilograms [dry or solid chemical product]
T = Tons [short ton = 2000 Ibs. or 907.2 Kilograms] [dry or solid chemical product]
U = Units [pesticide devices and pesticides that the label does not declare as Gallons, Pounds, Liters, Kilograms, or Tons]
ITEM 25. Amount (quantity) Produced/Repackaged/Relabeled Last Year (2000).
Enter the amount of the pesticide product or number of devices produced/repackaged/relabeled at the establishment
during calendar year 2000.
ITEM 26. Amount (quantity) Distributed/Sold Last Year (2000) in the United States.
Foreign producers should enter only the amount of product (number of devices) sold/distributed in the US.
Enter the amount of the active ingredient, pesticide product, or number of pesticide devices
produced/repackaged/relabeled by the establishment that was actually distributed/sold in the United States in 2000,
regardless of when the product was produced/repackaged/relabeled.
ITEM 27. Amount (quantity) Distributed/Sold Last Year (2000) to Foreign Markets.
Foreign producers should leave Item 27 blank.
Enter the amount of the active ingredient, pesticide product or number of pesticide devices,
produced/repackaged/relabeled by the establishment that was actually exported from the United States in 2000,
regardless of when the product was produced/repackaged/relabeled.
ITEM 28. Amount (Anticipated) To Be Produced/Repackaged/Relabeled This Year (2001).
Enter an estimate of the amount of the active ingredient, pesticide product, or number of pesticide devices that you
expect to produce/repackage/relabel at the establishment during 2001.
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-49
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FIFRA Inspection Manual, July 2002
Avoid these Common Errors
No signature. • Official name arid title missing or not legibly printed.
No date. • Address changes not made on the label.
Establishment mailing address not entered. • Reports completed in pencil rather than ink.
Blank boxes D in Items 16-24. « Report mailed after March 1 deadline.
Wrong Registration number entered for a product. • Definition of "produce not understood (sec page 2)
(Check your product labels.)
Incomplete reports may be returned to the establishment for completion.
" " ~ ' " ~ '
Name and Address Changes
All companies or establishments must provide name and address changes to the EPA within 30 days after such change
occurs. Domestic companies or establishments should send such information to the Regional office where the company
headquarters is located. Foreign companies or establishments should send such information to the EPA Washington,
D.C. office. SEE PAGE 7 FOR ALL U.S. EPA MAILING ADDRESSES
Confidentiality
If you wish to assert a claim of confidentiality for certain information you have provided on this Form, you must identify
by the box nurnber(s) the information that you are asserting a claim of confidentiality and designate such information as
confidential. Information so designated will be disclosed by the FPA only to the extent allowed by, and by means of, the
procedures set forth in, 40 CFR Part 2. If you do not claim the information as confidential upon submission, it may be
made available to the public without further notice to you.
Under FIFRA Section 7 (d) [136e], information reported in Items 25, 26, 27, and 28 of EPA Form 3540-16 will be treated
as business confidential, subject to the provisions of FIFRA Section 10 1136h], No claim is needed lo keep this
information confidential.
Producers of Multi-use Chemicals
Producers of chemicals that have both pesticidal and non-pesticidal uses are required to register their establishments and
report their production on an annual basis under Section 7 of FIFRA, if the producer has actual or constructive
knowledge that a chemical or substance they produce is used or intended for use as an active ingredient in the
manufacture of a pesticide. These producers are required lo report only the amount of chemical or substance
manufactured and distributed or sold for pesticide purposes.
Public Reporting Burden
For this information, the time required is estimated to average one hour 26 minutes per response, including reviewing
instructions, searching data sources, gathering and maintaining data needed, and completing review and collection of
information. Send comments regarding this burden estimate or other aspects of this information collection, including
suggestions for reducing this burden, to: Director, OP/ORM1 Regulatory Information Division (2137), U.S.
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW, Washington, D.C. 20460, Attention: Desk Officer
for EPA, and to the Paperwork Reduction Project, Office of Information and Regulatory Management Affairs, Office of
Management and Budget. 725 17"' Street. NW.
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-50
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FIFRA Inspection Manual, July 2002
SUBMIT REPORTS FOR DOMESTIC ESTABLISHMENTS to YOUR REGIONAL OFFICE
EPA Regional Offices
I'.S. EPA Region 1
Lee Weller
PC) Box 8636
States/Terr.
Covered
C T, MA
ME, NH
Rl.VT
EPA Regional Offices
I . S. EPA Region 6
James Redd
Pesticides Section (6PD-P)
States
Covered
AR, LA
NM, OK
TX
Boston. MA 02114
Telephone 617-918-1849
[Note ne\v mailing address]
I'.S. EPA Region 2 NJ, NY
David Salkie PR, VI
Pesticides Team (MS-500)
Building 5
2890 Woodbndge Avenue
Hdison. NJ 08837-3679
Telephone 732-321-675(1
U.S. EPA Region 3 DE, DC
Kyla Townsend-Mclntyre MD, PA
Pesticides Programs (3WC32) V A, WV
1650 Arch Street
Philadelphia. PA 19103-2029
Telephone 215-814-2045
U.S. EPA Region 4 AL, EL
Jacquelyn Wilkerson CiA, KY
AFC Pesticides Section (APTMD) MS, NC
61 Forsyth Street. S\V SC, TN
Atlanta. GA 30303-3104
Telephone 404-562-9011
U.S. EPA Region 5 IL, IN
Gail Muffin MI, MN
PTI-:S(DT-8J) OH.VVI
"~ \V. Jackson Bl\d.
Chicago. IL 60604-3507
Telephone 312-886-6008
1445 Ross Avenue
Dallas. TX 75202-2733
Telephone 214-665-7560
I. S. EPA Region 7 IA, KS
Lou Banks MO, NB
Pesticides Branch (WWPDPEST)
901 North 5"' Street
Kansas City. KS 66101
Telephone 913-551 -71 25 7463
U. S. EPA Region 8 CO, MT
Cornelia Maes ND, SI)
Enforcement Division (EN'F-PT) UT, WY
999 18th Street. Suite 300
Denver. CO 80202-2466
Telephone 303-31 2-6049
U. S. EPA Region 9 AZ, CA,
Glenda Dugan HI, NV
Pesticides Section (CMD-4-3)
75 FknMhorne Street
San Francisco. CA 94105
Telephone 415-744-1066
U. S. EPA Region 10 AK, ID
Eva Chun OR, NV A
Pesticides Unit (FCO-084)
1200 Sixth Avenue
Seattle. WA 98101
Telephone 206-553-1970
SUBMIT ""REPORTS for FOREIGN EST.ABLJSHMF.NTS to the \\ASHINGTON. DC OFFICE
Carol !.. Buckingham (Room 6118) Telephone 202-564-5008
1 S Fnvironmenta] Protection Agenc>
Agriculture and Lcos\stem Division (2225A)
1200 Pennsxhania Avenue. N\V
Washington. DC 20460 t'SA
The Agency does not notify you when your Report is received.
In order to ensure that your firm has satisfactory evidence that the Regional Office received this report, you
ma\ wish to send the report to the Regional Office by certified or registered mail, return-receipt requested.
with a cover letter.
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-51
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FIFRA Inspection Manual, July 2002
Exhibit 7-10: Conducting the Labeling Review
Producer Establishment Inspections
When a producer establishment inspection is being conducted, a word-for-word comparison with the
registered label, when available, should be made of all labels being reviewed. The inspector should
ascertain compliance with all stipulations of the letter of acceptance.
The inspector may label comparisons to "bin" labels at the discretion of his/her supervisor. Official
samples may only be collected from the products that are packaged, labeled, and released for shipment.
However, a "bin" labeling review can provide a valuable background for follow-up sampling at
consignees and obtaining voluntary corrective action at the producer level.
Marketplace Inspections
When conducting labeling reviews, the inspector should be aware of labeling requirements and be alert
for products that may be violative. The following paragraphs list some of the things an inspector
should be aware of:
Product Name. Brand, or Trademark
Name of Manufacturer. Registrant, or Person for Whom Manufactured. If the product is not
produced by the registrant, the name must be qualified by "packed for...," "distributed by...,"
"sold by...," or a similar statement.
EPA Registration Number. The EPA Registration Number may be listed as "EPA Registration
No. XXXX-XX," "EPA Reg. No. XXXX-XX," or "EPA Reg. No. XXX-XX-YYYY." (The
"YYYY" is the supplemental registrant's company number.)
EPA Establishment Number. The EPA Establishment Number may appear in any location on
the label or immediate container; however, it must appear on the outside container or wrapper of
the package if the EPA Establishment Number on the immediate container cannot be clearly
read through the outside wrapper or container. It must be listed as "EPA Est. XXXX-(State
abbreviation)-XX," or "EPA EST NO. XXXX (State abbreviation)-XX"
Net Content Statement. The net contents must be given in units commonly used in the United
States (i.e., pounds, ounces, pints, quarts, gallons). Metric Units may also be listed. Liquid
units must be used if the product is liquid and weight units must be used if the product is solid,
semisolid, or viscous. Contents must be expressed in terms of the largest unit present.
Ingredient Statement. The ingredient statement usually appears on the front panel. The names
used for each ingredient shall be the accepted common name, if there is one, followed by the
chemical name.
The common name may be used alone if it is well known.
NOTE: The ingredient statements for products containing arsenic must have a substatement
giving the percentage of total and water-soluble arsenic, each calculated as elemental arsenic.
Warning or Citation Statements. The signal words, "Danger," "Warning," or "Caution" and the
statement "KEEP OUT OF THE REACH OF CHILDREN" must appear on the front panel of
the label. Any substances in quantities highly toxic to humans must bear all of the following on
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-52
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FIFRA Inspection Manual, July 2002
the label: (1) a skull and crossbones, (2) the word "POISON" in red on a contrasting
background, and (3) a statement of practical treatment. In addition, the label must contain
precautionary statements necessary to prevent injury to humans and the environment.
Directions for Use. Directions for using the product must include the following: (1) the site of
application, (2) the rate of application, (3) instructions for frequency and timing applications,
(4) restrictions and warnings, (5) any other pertinent information necessary for the protection of
the public, and (6) target pest.
Legibility of Labeling. Product labeling must be clearly legible and easy to read by a person
with normal vision. All required label or labeling text shall appear in the English language.
However, the Agency may require or the applicant may propose additional text in other
languages as is considered necessary to protect the public. When additional text is necessary,
all labeling requirements will be applied equally to both the English and other language versions
of the labeling.
Disclaimer Statements. Labeling disclaimers that negate or distract from required labeling
information are not acceptable. The following are examples of unacceptable and acceptable
disclaimers:
• Unacceptable. "The information furnished hereon is provided gratuitously by the
manufacturer, who assumes no responsibility whatsoever for the effectiveness or safety
of this product, regardless of whether or not it is used as directed."
Acceptable. "Seller makes no warranty, expressed or implied, concerning the use of
this product other than indicated on the label. Buyer assumes all risk of use and/or
handling of this material, when such use and/or handling is contrary to label
instructions."
Statement of Use Classification. All RUP products must have the RUP statement on the top of
the center of the label.
If a review of "bin" labels, for which there is no product packaged, labeled, and released for shipment,
reveals a discrepancy, it should be brought to the attention of the management. Names and addresses of
the consignees of the misbranded product should be obtained to follow up the investigation and collect
samples of the product.
Marketplace Inspections
Samples should be collected of all products found with the violative labels or labeling. The inspector
should exercise care in obtaining the proper shipping records that cover all of the products in stock.
If the inspector is unsure of any label or labeling or if a serious violation has been discovered, he/she
should call his/her supervisor while still in the vicinity of the establishment. The supervisor may have
been access to information on the product that would help to decide whether to have the product
sampled or even stop sale the product.
Accompanying Labeling
Copies of accompanying labeling initiated and dated by a responsible company representative should
be collected and documented.
When violative labeling is collected, it should be documented with a statement signed by a responsible
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-53
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FIFRA Inspection Manual, July 2002
individual of the firm, which clearly states that relationship of the labeling to the goods including the
following:
Description of Labeling. Describe briefly each piece of literature by name and also the
manner in which the literature was received. State the quantity of such labeling on hand.
Location of Labeling. Report the location of each piece of literature and how much each
is on hand
• Methods of Distribution. Determine how the labeling is distributed (i.e., accompanied
product, shipped under separate cover).
Source of Labeling. Was the labeling sent to the dealer by the shipper of the product or
was it prepared by the dealer himself? If received from the shipper of the product,
document the shipment of the labeling. If prepared by the dealer, determine whether the
producer provided the test.
• Instructions to Dealer. The manufacturer or shipper sometimes provides sales promotion
instructions to the dealer. Obtain copies of such instructions, if available, as well as any
verbal instructions on how to use them.
Chapter Seven • Pesticide Producing Establishment and Marketplace Inspections • 7-54
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Chapter Eight
INTERAGENCY PESTICIDE REFERRALS
Table of Contents
Page
AUTHORITY 8-1
OBJECTIVE 8-1
POLICY 8-1
PROCEDURES 8-2
Referrals from EPA to FDA and USDA 8-2
Referrals from EPA to State Agencies 8-3
Exhibit 8-1: Interagency Referral Form 8-4
Chapter Eight • Interagency Pesticide Referrals • 8-i
-------
CHAPTER EIGHT
INTERAGENCY
PESTICIDE REFERRALS
AUTHORITY
Section 22(b) of FIFRA, as amended, authorizes the Administrator
to cooperate with other federal and State agencies in carrying out
the provisions of the Act.
OBJECTIVE
The objective is to improve management controls and response to
pesticide-related cases that are referred between:
*• Environmental Protection Agency (EPA) and the Food and
Drug Administration (FDA),
*• EPA and the United States Department of Agriculture
(USDA), and
*• EPA and the United States Customs Service (Customs).
POLICY
The Memorandum of Understanding (MOU) between FDA,
USD A, Customs, and EPA on Regulatory Activities Concerning
Residues of Drugs, Pesticides, and Environmental Contamination
in Foods (signed December 7, 1984; 50 FR 2304) provides that an
FDA district office will notify the appropriate EPA Regional office
when it encounters, through investigation or sample analysis,
pesticide residues on foodstuffs that may be the result of the
misuse of pesticides. EPA, in turn, will notify FDA whenever
pesticide misuse is found which might result in illegal pesticide
residues in food. Each agency is to keep the other agency informed
of the results of its follow-up and regulatory actions, with USDA
concerning residues of pesticides on agricultural commodities
including meat and poultry, with Customs on notification of
registered/unregistered and illegal imported pesticides.
Chapter Eight • Interagency Pesticide Referrals • 8-1
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FIFRA Inspection Manual, February 2002
PROCEDURES
To improve the quality of referrals from FDA, USD A, and
Customs to EPA, FDA, and USDA field staff must refer cases of
suspected pesticide misuse to EPA only when all of the following
conditions are met:
*• FDA or USDA has evidence dearly demonstrating that the
pesticide was used on the food, feed, meat, or poultry in a
manner contrary to its EPA-approved use and labeling.
*• FDA or USDA laboratory results (original and check
analysis) show residues of a pesticide for which FDA
regulatory action would be initiated against the food, feed,
meat, or poultry because:
• The tolerance for the pesticide is exceeded.
• No tolerance (or exemption from tolerance) has been
established or the tolerance has been revoked and the level
of residue appears to be due to purposeful use as opposed
to environmental or some other unavoidable source of
contamination.
• The misuse occurred while the food, feed, meat, or poultry
was in domestic production, shipment, or storage. (Note:
Imports found to contain illegal pesticide residues at time
of entry are not to be referred to EPA). FDA and USDA
retain authority to detain, seize, or destroy the illegal
contaminated commodity.
• The person or firm that misused the pesticide is known or
suspected.
Customs will notify EPA on each entry of registered, unregistered
or illegal pesticides potentially entering U.S. commerce.
FDA and USDA also will inform EPA of any other State or local
agencies that have been notified.
Referrals from EPA to FDA and USDA
The nature and location of EPA inspections make it unlikely that
many referrals of potentially illegal residues will be made from EPA
to FDA or USDA. When EPA discovers situations, however, that
might result in illegal residues, they must be referred to the FDA or
USDA district office so that the crop, food or feed, meat or
poultry, and/or a product can be intercepted and tested as
necessary. Examples of situations that might result in illegal
residues include accidental pesticide spills, excessive pesticide use in
a crop nearing harvest, fruit or grain fumigation over the prescribed
rates, and pesticide misuse in a food-processing facility, or the
misuse of pesticides in and around slaughter houses. Other
examples may include EUPs, section 18 emergency exemptions,
and use of canceled pesticides.
Chapter Eight • Interagency Pesticide Referrals • 8-2
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FIFRA Inspection Manual, February 2002
Referrals from EPA to State Agencies
The EPA response to FDA and USDA illegal residue referrals will
normally be a referral to the appropriate State lead pesticide agency
for follow-up. Referrals will be tracked and reported to FDA and
USDA in accordance with procedures established by the Regions.
A suggested format is attached as Exhibit 8-1.
Emergency situations may arise that require immediate interagency
action such as serious pesticide misuse or incidents that may result
in harmful human exposures. In these instances, the necessary
agencies must be notified immediately by telephone with all
information that is readily available so that the hazardous situation
can be corrected promptly.
Chapter Eight • Interagency Pesticide Referrals • 8-3
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FIFRA Inspection Manual, February 2002
Exhibit 8-1: Interagency Referral Form
1. REFERRAL TO
Agency:
Location:
3. DATE REFERRAL FORWARDED
Date Mailed:
Advance Telephone Notification Given:
CH No
EH Yes Date:
To Whom:
2. REFERRED BY
Agency:
Referring Official:
Phone Number:
4. OTHER AGENCIES NOTIFIED
Other Agencies Notified and Contact Person in Each:
5. DESCRIPTION OF INCIDENT/REASON FOR REFERRAL
6. FIRM RESPONSIBLE
Name and Location of Firm Responsible for Problem:
8. DATE REFERRAL RECEIVED
Date of Telephone Notification:
Date Received by Mail:
7. FIRM (INDIVIDUAL) AFFECTED
Name and Location of Firm or Individual Affected
Problem:
by
9. REVIEWING OFFICIAL
Name/Title of Person Responsible for Determining
to Referral:
Phone Number:
Response
10. FOLLOWUP DECISION
1 1 Immediate Followup
1 — 1 Non-Immediate Followup
1 1 Referred to Another Agency
Specify Agency and Contact:
1 1 No Followup
Reason:
Date Followup Decision Made:
11. ACTION TAKEN
Describe followup and results.
12. FEEDBACK REPORT
Send a copy of completed form to this address at referring agency:
Referring Agency: Complete Blocks 1-7 and 12.
Receiving Agency: Complete Blocks 8-11, and send to address in Block 12.
Chapter Eight • Interagency Pesticide Referrals • 8-4
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Chapter Nine
FIFRA PESTICIDE PRODUCT SAMPLING
Table of Contents
Page
AUTHORITY 9-1
OBJECTIVES 9-1
POLICY 9-2
SAMPLE COLLECTION 9-2
Sources of Pesticide Samples 9-2
Marketplace Inspections 9-3
Potential Inspection Sites 9-3
Entry 9-3
Persons Interviewed 9-3
Description of Activity 9-3
Label/Labeling Review 9-3
Pesticide Product Review 9-4
Shipping Records 9-4
Sampling 9-4
Narrative 9-4
Types of Samples 9-4
Sample Procedures 9-6
Small Sized Units 9-6
Larger Sized Units 9-7
Dry Material 9-7
Liquid Material 9-8
Labels 9-8
After Sampling 9-9
Restoring Lot to Order 9-9
Preparing Duplicate Samples 9-9
Preparing the Receipt for Samples 9-9
Payment for Samples 9-10
SAMPLE DOCUMENTATION 9-10
Responsibility 9-10
Records Showing Shipment 9-10
Invoices 9-11
Bill of Lading 9-11
Freight Bill 9-11
Waybill 9-12
Mail or Parcel Service Shipments 9-12
Shipments by Noncommercial Vehicle 9-12
Statements and Dealer's Statements 9-13
Statements 9-14
Refusal to Sign 9-14
Investigation Summary Report 9-14
Memorandum to Accompany Investigation Summary Report 9-14
SAMPLE PREPARATION, CUSTODY, AND HANDLING 9-15
Identification of Samples and Labels 9-15
Identification of Documents 9-15
Records 9-15
Accompanying Literature, Labeling, Photographs, and Exhibits 9-15
Physical Sample Custody 9-16
Preparing the EPA Official Sample Seal 9-16
Applying the EPA Official Sample Seal 9-16
Chapter Nine • FIFRA Pesticide Product Sampling • 9-i
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Sample Integrity and Sample Custody 9-16
Mode of Transfer 9-17
Hand Delivery 9-17
Common Carrier 9-17
U.S. Postal Service 9-18
Exhibit 9-1: Receipt for Samples (EPA Form 3540-3) 9-19
Exhibit 9-2: Copy of Invoice and Shipping Record (EPA Form
3540-13) 9-21
Exhibit 9-3: Dealer's Statement (EPA Form 3540-19) 9-22
Exhibit 9-4: Statement (EPA Form 3540-42) 9-23
Exhibit 9-5: EPA Official Sample Seal (EPA Form 7500-2) 9-24
Exhibit 9-6: Chain of Custody Record (EPA Form 3540-41) 9-25
Exhibit 9-7: Hazardous Materials Definition 9-26
Exhibit 9-8: Guide for Shippers 9-31
Exhibit 9-9: Guide for Hazardous Materials Shipping Papers 9-34
Exhibit 9-10: Mailability of Hazardous Materials 9-37
Chapter Nine- FIFRA Pesticide Product Sampling • 9-ii
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CHAPTER NINE
FIFRA PESTICIDE
PRODUCT SAMPLING
AUTHORITY
Section 9 (a) of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), as amended, authorizes any officer or employee duly
designated by the Administrator to enter, at reasonable time, any
establishment or other place where pesticides or devices are held
for distribution or sale for the purpose of inspecting and obtaining
samples of any pesticides or devices packaged, labeled, and released
for shipment, and samples of any containers or labeling for such
pesticides or devices.
Section 12(a)(2)(B) of the Act makes it unlawful for any person to
refuse to allow a "duly designated agent of the EPA Administrator"
to take a sample of any pesticide pursuant to section 9 or to inspect
records to be retained pursuant to section 8. If consent is not
obtained to enter the establishment, see Chapter 15 for obtaining a
warrant.
OBJECTIVES
An official sample of a pesticide formulation or device is necessary
for use as evidence in most of the enforcement actions taken as a
result of a producer, marketplace, or dealer inspection. A sample
must be suitable to support the government's charge that a
violation has occurred. The sample must conform to the rules
regarding admissibility of evidence. A properly collected, prepared,
and documented sample includes the following:
*• Sufficient portion of a batch of a pesticide for laboratory
analysis (as stated in other chapters of this manual, please
consult the lab that analyzes your samples and make sure
you are shipping enough quantity of sample, and that they
Chapter Nine • FIFRA Pesticide Product Sampling -9-1
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FIFRA Inspection Manual, July 2002
can analyze for that chemical or active ingredient, which will
be shipped to that location).
This may include photographs and or copies of records,
data, or correspondence.
Labeling and/or literature, or copies of these items, that
pertain to this product and/or batch, with signatures or
initials of the person who authorized the sampling.
Signed statements from persons who may potentially serve
as witnesses.
POLICY
Samples shall be collected and prepared in accordance with the
procedures outlined in this manual. The inspector shall fully
document any deviations from these procedures in his or her field
notebook. These discrepancies may be very important to the
laboratory analyzing the samples.
It is the Agency's policy to reduce to a minimum the amount of
time between the date of sample collection and the date that any
appropriate enforcement action is taken. The inspector plays an
important role in minimizing this interval by promptly delivering or
forwarding samples and records to the laboratory. Pesticide
formulation samples should not be held for more than five working
days from the time of collection to the time of shipment to the
laboratory.
SAMPLE COLLECTION
Sources of Pesticide Samples
There are three main potential sources of pesticide product
samples, 1) pesticide producing and device producing
establishments (discussed in Chapter 7), 2) Marketplace (discussed
in Chapter 7), and 3) Use/Misuse (discussed in Chapter 12).
Producer Establishment lists may be obtained from your EPA
Regional Office. An inspector may also be called on to sample
devices at a producer establishment. Further, Device Producing
Establishments should be inspected and labels of devices reviewed
for compliance with the statute, regulations, and polices.
Samples of unregistered pesticides, investigational samples, or those
pesticides that are not available for sampling at the producer level
may be sampled at a marketplace. This can include wholesale and
retail establishments, farm dealerships, seed, feed, and fertilizer
outlets, many home improvement stores, etc.
Chapter Nine • FIFRA Pesticide Product Sampling • 9-2
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FIFRA Inspection Manual, July 2002
Marketplace Inspections
Potential Inspection Sites*
> Animal health and veterinarian suppliers
*• Hardware stores
* Barber and beauty supply dealers
*• Dairy equipment and supply dealers
* Feed, seed, and fertilizer dealers
* Janitorial supply dealers
* Pest control operators
* Wholesale and retail grocers
*• Chemical suppliers
* Medical and dental suppliers
* Hotel and restaurant suppliers
*• Paint dealers, and boat supply dealers/boatyards
* Pest control operators
* Pool, spa, and waterbed dealers
*• Lawn and garden supply dealers
* Retail outlets (e.g., Wai-mart, K-mart, etc.)
*Not an inclusive list.
Entry
Present credentials and issue a Notice of Inspection to the most
responsible person present at the time of the inspection. If a
violation is suspected or if the inspection is not routine, the reason
for inspection and the suspected violation must be noted in writing
on the Notice of Inspection.
Persons Interviewed
> Name, address, and telephone number of facility.
*• Name, title, telephone number of person(s) interviewed.
Description of Activity
Brief description of facility or individual activities, i.e. janitorial
supply dealer, pest control company, wholesale grocer, etc.
Label/Labeling Review
A thorough label review of pesticides being offered for sale or
distribution should be conducted to verify compliance with the
registration requirements and to identify instances of suspected
misbranding. Also document collateral labeling and literature such
as shelf liners, advertising material, flyers, etc.
Note: Antimicrobials, treated articles, pet products, swimming pool
and pond products, paints, etc. are excellent products for review in
addition to typical farm, home, and garden pesticides.
Chapter Nine • FIFRA Pesticide Product Sampling -9-3
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FIFRA Inspection Manual, July 2002
Pesticide Product Review
* Note any products requiring child resistant packaging
* Note any canceled/suspended pesticides
* Observe products for leaking containers
* Note security/safety of restricted use pesticides in storage
Shipping Records
Suspected violations should be documented by collecting shipping
records to document the suspected violative product's movement
in the channels of trade. Recognizing that shipping records are
sometimes difficult to obtain in the marketplace, make every effort
to document at least five separate shipments/sales or collect
records documenting five separate days of shipments or sales,
whichever reveals the greater number. Inspectors are encouraged
to obtain computer-generated records. If records are unavailable,
document this fact in a statement or affidavit signed by the agent-
in-charge with an explanation of where the records are and how
they can be obtained.
Sampling
* Collect physical or documentary sample(s) of any/all
products suspected to be in violation
* Issue a Receipt for Samples
Narrative
Write a complete narrative of the inspection, in accordance with
establishment procedures.
Types of Samples
Official samples of pesticide products or devices are those that, if
potentially violative or otherwise problematic, serve as a basis for
legal or regulatory action. In general, an official sample is
categorized in one of five ways: physical, induced, documentary,
import, or use dilution.
*• Physical samples are actual samples of the pesticide
formulation, or device. The physical sample may include the
original labeled packaging, copies of or photographs of the
label and all other labeling associated with the pesticide or
device. Copies of any records showing the distribution or
sale of the physical sample will be collected for documentary
purposes. Copies of shipping records substantiating the
distribution or sale of the pesticide product or device are
vital to all enforcement cases (Samples usually consist of the
entire container of the pesticide or device).
* Also, often when large containers are involved or when
small amounts of a pesticide are necessary for analyses, the
inspector may choose to subsample the pesticide. This type
of sample consists of a portion of the pesticide removed from
the original container and placed in a subsample container
which has been properly identified. In addition, the label
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and any additional labeling and/or collateral literature
and/or photographs must be documented and identified
with the same number as the subsample container. The
official sample consists of the physical subsample and the
label/labeling and is counted as one sample.
Residue samples (see Chapter 13 for additional information),
primarily environmental (swabs, soil, water, vegetation,
etc.), are collected for a variety of reasons, but usually to
determine if pesticide residues are present in the media
sampled. These samples are collected in accordance with
federal sampling procedures and the sample containers are
identified with the sample number and the inspector's
initials. Photographs should be taken of the sampling area
in such a way to provide the reviewer with perspective of
what the inspector did and observed in the sampling area.
Photographs should be identified in the same manner and
with the same number as the sampling container.
An induced sample should not be considered until all other
sources for directly collecting the physical sample have been
exhausted. Induced samples of pesticides or devices are
usually requested by mail, telephone, or the internet.
Complete documentation is necessary, including the original
advertisement. A webpage printout may be considered
advertising of the pesticide product, but your supervisor
should be consulted before collecting this evidence.
Documentary samples are official samples collected in lieu of
physical samples or when the chemistry of a pesticide is not
suspect. Inspectors have some flexibility when collecting
documentary samples, but should strive to collect the best
evidence. In order of preference, documentary samples may
consist of:
• Photographs of the actual container observed by the
inspector at the time of inspection or investigation.
• Bin labels or specimen labels available at the inspection
site, such as during producer establishment inspections,
which have been authenticated by the agent-in-charge at
the time of the inspection as identical to the label on the
container viewed by the inspector. The authentication may
be written or stamped on the reverse side of the label
and/or labeling.
• Specimen labels or other labels obtained by the inspector
from sources other than at the establishment or place
where the pesticide was observed. The more removed a
specimen or other label is from the actual label observed,
the greater the effort must be to authenticate the label.
These labels must be authenticated by the agent-in-charge,
suspect or witness in an official statement or affidavit as
identical to the original label observed by the inspector.
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*• Import samples are physical or documentary samples of
pesticide formulations or devices that are offered for
importation into the United States from foreign countries.
Documentation for imported shipments should include U.S.
Customs Service entry papers, foreign invoices, shippers'
bills of lading, and records showing movement from the port
of entry (Refer to Chapter 14-Pesticide Import and Export
Program).
* Use dilution samples are collected during pesticide use
inspections. A formulated pesticide has been blended with a
carrier such as water, and is ready to be applied by an end
user.
Sample Procedures
Immediately following the collection of a sample, the sample shall
be identified, officially sealed, and documented in inspection notes,
and inspection forms. Official pesticide formulation samples are
normally collected only from material that is packaged, labeled, and
deemed released for shipment by the manufacturer. The term
"packaged, labeled, and released for shipment" refers to the point
in the production and marketing of a pesticide where (a) the
product has been produced, and (b) it is the intent of the producer
that such product be introduced into the channels of trade.
At the producer establishment level, such intent to introduce the
product into the channels of trade may be documented by 1) the
producers assertions that the material being sampled is
representative of what is actually sold in the marketplace, or 2) the
product is stored in a loading dock, warehouse, or other area where
finished goods are held before sale or distribution.
At the distributor level, in wholesale and retail marketplaces, the
product is considered "released for shipment" by the producer
establishment, and therefore subject to inspection and sampling.
Small-sized units
Small-sized units are those units containing liquids of one gallon or
less or solids weighing 20 pounds or less and are intended for retail
distribution. Samples shall be taken from original, previously
unopened shipping cases. If more than one batch or lot number is
present, samples shall be taken from the predominant code or
batch. If it is necessary to sample more than one batch or lot, all
lots and batches shall be written on the receipt of samples to
identify the lots or batches. If the labels are not identical, the
inspector shall sample all sizes and submit different sizes under
separate sample numbers. In addition, the inspector shall record
the number of cases of each size. All non-sampled lot numbers
shall be described in the Investigation Summary Narrative Report.
When only a case code is evident, each sample shall also be
identified with its case code. If different sized containers are
present and the labels are identical, except for net contents, only
one size needs to be sampled and the number of cases of each size
recorded in the Establishment Inspection Report (see exhibit 7-5).
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Table 9-1 shows the numbers of retail units that shall be collected.
However, the inspector should consult with the laboratory if
he/she is unsure or if unusual circumstances are encountered.
Table 9-1 - Sample Sizes to Collect for Pesticide Products
Product Type
Quantity to Collect
Small-Size Units
Active Ingredients more than
1%
Active Ingredients less than
1%
Pressurized containers
Collect enough units to total at
least 4 02.
Collect enough units to total at
least 4 02.
Collect at least three units
Larger Size Units (Liquids and Solids)
Active ingredients less than
10%
Active ingredients more than
10%
Tank Mixes
Collect at least 4 02 from each
of two containers*
Collect at least 4 02. from each
of two containers*
Collect at least one 4 02.
sample in addition to a 4 02.
sample of the formulation
(refrigerate immediately)
* Sample each container in duplicate if any non-uniformity is evident (i.e.,
layering, sediment, gross particle-size differences or color non-uniformity.)
Larger-sized Units
Larger-si2ed units (formerly called "bulk samples") are defined as
those units that contain more than one gallon of liquid or weigh
more than 20 pounds of solid material, and are typically offered for
commercial use. Subsampling of larger containers is usually
recommended for the following reasons: 1) the cost of larger
amounts is frequently prohibitive; 2) the Iarger-si2ed units are
difficult to handle and costly to ship; and 3) the increased amount
of material left over after testing creates disposal problems.
The inspector shall subsample dry pesticides packaged in containers
which are in excess of 20 pounds, and liquids packaged in
containers in excess of one gallon. Special situations warrant
deviations from these guidelines, in which, the entire retail unit
should be sampled and submitted to the laboratory
Dry Material
A previously unused, disposable plastic tube, available from golf
equipment suppliers or home supply stores, or clean grain trier
(Fisher #14-208 or equivalent) should be used for each batch or lot
sampled to avoid any possibility of contamination. The tube or
trier shall be clean and/or cleaned with a proper solvent and it shall
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be inserted diagonally into the bag through the seam or the "dog
ear" to obtain a representative sample of the material from
different sections of the bag. Glass or metal (paint type) containers
shall be used to contain the sample. Either a Teflon or
polyethylene-lined lid may be used in conjunction with the glass
containers for formulation samples.
The tube and other contaminated sampling material shall be
disposed of properly and in a satisfactory manner. The trier shall
be throughly cleaned with soap and water and or solvent, and dried
before each use or reuse.
See Table 9-1 for recommended sample sizes to collect; consult
with the laboratory if you are unsure.
Liquid Material
A previously unused, clean, disposable plastic tubing, glass thief, or
siphon shall be used for each batch or lot sampled to avoid any
possibility of contamination.
If the label directions so state, the material shall be throughly
agitated by rolling and shaking the can, barrel, or drum before
sampling. Glass bottles shall always be used for sample containers.
Either Teflon, or polyethylene-lined lids are satisfactory for liquid
formulation samples. Do not use rubber or paper-lined lids. The
tubing and other contaminated sampling material shall be disposed
of properly and in a satisfactory manner. Consult with your
sample analysis laboratory if you are unsure of the amount of
product to sample.
A vaccutaner with siphon tube, which has a vacuum in the tube,
usually used for blood sampling, can be used in some cases to
sample liquid material in large containers. It is relatively easy to
use, and does not have a large amount of waste to be disposed,
other than the tube and sample needle that is used to puncture the
end of the vaccutaner. These devices may be purchased from
hospital supply stores, and are an inexpensive method of sample
collection. Also, decreased exposure to the inspector from the
pesticide itself may be an additional advantage for using this type of
sampling container.
Labels
A duplicate label, copy, or photograph of the label must accompany
each sample. The label must not be removed from containers,
because this will result in the pesticide being misbranded. Bin
labels may be used for this purpose. The inspector must make
word-for-word comparison of this label with the labeling on the
container sampled to ensure that they are identical. If bin labels are
not available from another source, fully legible photographs of the
label are necessary. Another photograph of the entire container,
showing the position of the label on the container, should also be
obtained. Polaroid, instant processing, 35mm, or digital cameras
may provide the word-for-word substitute for a label, if the camera
can zoom in on the label language.
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An inspector shall be careful to view the digital photo, if possible,
to see if the image is sharp enough to obtain the word-for-word
comparison of specimen and actual product labeling.
After Sampling
Restoring Lot to Order
The inspector shall attempt to restore a sampled lot on the
premises to an orderly condition. If several cases have been
opened, these containers should be backfilled and re-closed when
possible. Some facilities will restore lots to order after inspectors
sample and may instruct an inspector to allow them to restore the
area to its presampling condition. Spillage should be cleaned up
and larger containers closed, handtrucks, tools, rags, glue pots, and
other supplies or equipment should be returned to their proper pre-
sampling position
Preparing Duplicate Samples
If the inspected facility requests duplicate samples, they shall be
collected, identified and officially sealed in the same manner as the
official samples were handled. In the case of a larger sized unit,
EPA defines a duplicate sample as an equal amount of the product
taken in the same manner from the same container. In the case of
small-sized units, a duplicate sample is defined as the same number
of units taken from the same shipping containers and bearing the
same batch or code numbers, if coded.
Although a company may request half the contents of a small-sized
unit as their equal portion, small-sized units shall not be subdivided
for the following reasons: 1) The integrity of the sample is more
difficult to maintain and defend; 2) contamination during sampling
is minimized; 3) the possibility of exposure to the inspector and
personnel of the firm is diminished; and 4) the laboratory can
conduct a net content check on the unit collected, if necessary.
Preparing the Receipt for Samples
The preparation of the Receipt for Samples (EPA Form 3540-3)
(Exhibit 9-1) should be self-explanatory. It is the inspector's
responsibility that the facility representative understands that by
signing the Receipt, he/she is acknowledging the fact that the
samples and documentation were obtained from products that were
packaged, labeled, and released for shipment, or having been
shipped, were being held for distribution or sale. Copies of the
Receipt for Samples shall be distributed as follows: 1) the
Establishment Copy shall be provided to the facility; 2) the
Establishment Inspection Report copy shall be attached to the
inspection report; 3) the Sample Record Copy shall be attached to
the Investigation Summary Report, and if a receipt covers more
than one sample, it should be attached to the Investigation
Summary Report bearing the lowest sample number; 4) the
Collector's Copy shall be retained by the inspector.
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Payment for Samples
Payment shall be offered for samples collected, no matter how
small the amount collected. Distributors and dealers are entitled to
invoice costs plus a nominal charge (usually 10 to 15%) for freight,
handling and storage. Producers are entitled to their production
cost. Payment shall be made in cash; reimbursement will normally
be made by a travel voucher or by petty cash. Some companies
may accept a government purchase request if arranged by the
facility during the inspection. A producer may elect to bill the
government for the samples.
SAMPLE DOCUMENTATION
Responsibility
Documentation of samples is to be accomplished in accordance
with procedures outlined in this section. The inspector shall ensure
that the records obtained are those covering the specific pesticide
product(s) ordevice(s) that were sampled.
Do not remove the dealer's single copy of any record. If duplicates
are not available, photocopy, photograph, or hand copy all
necessary records. Reproductions shall be examined to ensure that
the copy clearly contains all relevant markings. Hand copies of
records on EPA forms must be accurate and legible.
All copies must be identified in the inspector's handwriting with the
sample number and the inspector's initials. The inspector shall
mark "EPA," the date and his or her initials in an inconspicuous
manner on the reverse side of the original records from which
copies were made. If the firm's record has information on both
sides, the inspector's identification shall appear inconspicuously in a
clear space and be circled. These procedures will ensure positive
identification of the document copies in question.
For distributor-level violations, the inspector shall document the
handling and storage of the sampled product, and establish the
source and distribution for any accompanying literature and or
labeling.
Records Showing Shipment
The collection of records that document the movement of
pesticides or devices in the channels of trade are integral to sample
collection. These records indicate the responsible party in
misbranding and/or adulteration cases and are key to shifting
primary responsibility away from the retailers. In addition, since
each shipment or sale of a violative pesticide constitutes a separate
act, shipping records are necessary to determine the gravity of the
violation (s) and are thus important in establishment of an
appropriate penalty. With this in mind, when significant violations
are suspected, such as but not limited to unregistered or
canceled/suspended pesticides in the channels of trade and
seriously misbranded pesticides with no label, directions for use
missing or obscured, ingredient statement missing, illegible label,
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etc., inspectors should attempt to document at least five separate
shipments/sales or collect records documenting five separate days
of shipments or sales whichever reveals the greater number.
Invoices, transportation, shipping and/or purchase records shall be
obtained for each official sample of a pesticide collected. The
collection of computer generated records indicating
shipments/sales of suspect pesticides is encouraged. The records
must be identified in the same manner as the physical or
documentary sample itself. Records collected during separate
inspections or absent an official sample should be identified as an
exhibit as described above. No Receipt for Samples is necessary
when records alone are collected, nor is it necessary to list records
collected as part of official sampling activities on the Receipt. A
statement signed by the dealer, identifying both the lot sampled,
and/or the applicable records. As stated above, the inspector shall
have the dealer sign and initial the copies of the records obtained to
prove that he/she provided them on the date of the inspection.
Invoices
These documents show the seller's intent to offer the pesticide or
device for sale or distribution. It may provide such information as
the value of the goods, carrier, date of shipment, and other
information. If duplicates or photocopies of the invoices are
unavailable, the invoice shall be photographed or copied by hand
on section 1, of EPA Form 3540-13, "Copy of Invoice and
Shipping Record" (see Exhibit 9-2). Other records that may be
substituted in the absence of an invoice are purchase orders,
receiving records, canceled checks, and or correspondence.
Bill of Lading
The bill of lading (BL)is made out by the shipper who delivers the
goods to the carrier for shipment. It is an order for the carrier to
move the goods. When the carrier's agent signs the bill of lading,
he or she acknowledges receipt of the shipment. Note that the date
the carrier's agent signs the BL is the date of the shipment, and this
may or may not be the same date that the bill is filled out. The
carrier's office in the city of origin of shipment will maintain a copy
of the BL. The following information is normally found on the
bill: 1) name and address of shipper, 2) name and address of
consignee, 3) date of shipment, 4) name of carrier, 5) rail car
number, and 6) a description of the goods. If duplicate copies or
photocopies are unavailable, the inspector should obtain a
photograph or hand copy the bill of lading on section 1 of EPA
Form 3540-13.
Freight Bill
This record is completed by the transportation company for the
purpose of collecting freight charges. It should include the same
information as found in the BL, plus additional information about
the carrier's handling of the shipment and cost involved. Railroads
prepare freight bills at their destination offices, where copies can be
obtained. Steamship and airline companies usually combine the BL
and freight bill into one form. Copies are filled at both the origin
and destination offices of these carriers. Truck lines prepare freight
bills at the originating office, and both the origin and destination
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offices should have copies. The pesticide dealer will usually have a
freight bill if he/she received the goods directly.
The inspector shall obtain a photograph or photocopy, or if
necessary, hand copy the freight bill into section 11 of EPA Form
3540-13. The type of shipping record shall be entered in block 23
of the form. Sections 1 and 11 may be executed together on one
sheet if necessary. If only one section is used, leave the other
section blank and submit the entire page of Form 3540-13.
Waybill
A transportation company uses a waybill in its own operations.
The waybill accompanies the shipment during transit. Copies are
not given to the shipper or consignee, but they can be obtained
from the carrier, if necessary. Other transportation records are
generally more readily available than waybills. Air freight waybill
numbers are so designed that the originating line and point of
origin are encoded withing the waybill number. Each airline has a
numerical code description indicated by the first two digits of the
number. The three subsequent letters indicate the point of origin.
For example, waybill number 01LGA, designates American Airlines
(01) as the carrier, and La Guardia Field (LGA) as the point of
origin. Most airline offices have a copy of "Official Air Freight
Transmittal Manual", which lists all the codes. Waybills may be
photographed or hand copied into section 11 of EPA Form 3540-
13, if duplicate copies or photocopies are unavailable.
Mail or Parcel Service Shipments
Marketplace samples - The inspector shall attempt to obtain the
original wrappings, which show cancellation of origin office and
address sticker. If the original wrappings are not available, the facts
concerning the shipment should be obtained from the dealer in a
signed statement.
Induced samples — When the inspector receives an induced sample
directly from mail or parcel service, the sample documentation shall
include the portion of the wrapper showing name and address of
the sender, the postmark, or postage meter tape or any shipping
marks. A copy of the air bill or other shipping record is also to be
maintained as part of the sample documentation. Other necessary
records include photocopies of the money order or cancelled
check, and the letter placing the order, and the original
advertisement.
Shipments by Noncommercial Vehicle
When shipments of a pesticide has been made by a vehicle
operated by the shipper or dealer, and no commercial shipping
records were made or are available, the inspector shall obtain a
statement of the facts concerning the shipment. The statement will
cover the facts known to him or her regarding the actual point of
origin, date of shipment, the ownership and operator of the vehicle,
and identification of any invoice from the shipper, or the dealer's
receiving record.
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Statements and Dealer's Statements
The Dealer's Statement is obtained from persons who have dealt
with the goods sampled and who know the facts relating to the
movement and events that might affect their condition. These
facts, recorded in writing and signed by the person who can testify
in court to those facts, can be used to establish responsibility for a
potential violation. The statement may be used to testify to the
identity of sampled goods. Also, it can certify that the inspector
collected a sample from the batch of pesticide products covered by
the records. A completed Dealer's Statement, EPA Form 3540-19,
is shown in Exhibit 9-3.
A statement fulfills the same function as an affidavit, but differs in
that it is not given under oath. The affidavits will not normally be
used by the federal inspector. Statements are normally used for
marketplace samples when complete shipping records are not
available to establish the origin of the material being sampled.
They are also used when available literature bears pesticide claims
or oral representations have been made regarding the products use,
which are not on the direct labeling. Statements are also employed
in use and follow-up investigations when documenting the
responsibility for an apparent violation.
Statements
The use of the Statement by inspectors during inspections and
investigations is strongly encouraged and is considered mandatory
in some cases. While legally considered hearsay, statements are
admissible under certain circumstances as evidence in
administrative proceedings. They tend to lock in a witness'
testimony, they can be used to impeach testimony if a witness
changes their story and can even be used in lieu of testimony in
certain circumstances. While an inspector's narrative may contain
the same information, the narrative is not signed by the affiant or
the person providing the statement.
There is no prescribed format to be followed in composing the
statement. The facts shall be arranged in an order on EPA Form
3540-42 (Exhibit 9-4). Usually, the most manageable composition
will be narrative in which the events and circumstances are
presented chronologically. Whatever format is used, the recorded
facts must be understandable to a reader who may be unfamiliar
with the situation.
When preparing the statement for signature, the inspector shall
proceed as follows: 1) ascertain all the facts and record those that
are material, relevant, and to which the interviewee can affirm; 2)
narrate the facts in the words of the interviewee, using the first
person singular; 3) break the statement down into logical
paragraphs if it is long and complex; 4) positively identify the
interviewee as the beginning of the statement (include the address
and phone number where he or she can be reached); 5) give the
interviewee's reason why he/she is qualified to make the statement;
6) set forth the pertinent facts in the body of the narrative;
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7) have the interviewee read the statement and make necessary
corrections before signing the affidavit/statement. (Mistakes that
require correction must be initialed by the interviewee.)
The following is an example of a statement that can be used when
obtaining documentary samples:
"My name is Jane Doe and I am the production manager for ABC
Corp. in Chicago, IL. As such, I oversee the shipment of all
products, including pesticide products, that leave the warehouse.
To the best of my knowledge, the bin label for the product, Mighty
Roach Killer, that was collected by Inspector Clouseau as sample
number 010101-82467-001-MP, is a true and accurate
representation of the label that was affixed to the product Mighty
Roach Killer that was shipped on January 5, 2001, as indicated in
the shipping record collected by Inspector Clouseau as sample
number 010101-82467-001-MP."
A concluding paragraph in the interviewee's own handwriting
declaring that he/she read and understood the statement is a
valuable safeguard to counter the possibility that the signer might
later claim he/she did not know what was being signed. A
situation could arise where a product that is sampled lacks a
statement on the label or labeling identifying it as a pesticide. In
such a case, the inspector should include a statement that the
product was purchased for intended pesticide use and is either
being used or sold as a pesticide.
Refusal to Sign
After the statement has been prepared, it shall be read by the
potential signatory or read to him/her before signing. If the person
refuses to sign, the inspector shall elicit an acknowledgment to the
effect that the statement is true and correct. He/she shall be asked
to write in his/her own hand, at the bottom of the statement, "I
have read this statement and it is true, but I am not signing it
because " Failing that, declare at the bottom of the statement
that you recorded the above facts as the dealer revealed them, that
the dealer read the statement, and the dealer avowed the statement
to be true. Attempt to have any witness to the statement sign the
statement with his/her name and address. A copy of the statement
is to be furnished to the signatory upon request.
Investigation Summary Report
An Investigation Summary Report or equivalent will be completed
for each pesticide formulation sample collected. The Region will
provide specific instructions on completing the appropriate form,
or narrative.
Memorandum to Accompany Investigation Summary Report
Some sampling operations require additional narrative details that
do not readily fit into the spaces provided on the Investigation
Summary Report. Such details should be entered on a separate
memorandum titled "Memorandum to Accompany Investigation
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Summary Report Sample No. XYZ." A copy of this memorandum
must be attached to each copy of the Investigation Summary
Report.
SAMPLE PREPARATION, CUSTODY, AND HANDLING
Identification of Samples and Labels
Each sample is to be identified in the inspector's handwriting with
the date, sample number, and the inspector's initials in the form:
date(mmddyy) - inspector's number - inspection sequence -
inspector's initials (e.g. 010101-82467-001-MP). This information
is written with permanent ink (e.g. Sharpie® Permanent Marker) on
the container so as to not obscure any portion of the label (ing) or
package. When more than one unit is collected, each unit shall be
identified further with a subnumber or letter. This identification is
normally placed in conjunction with the date, sample number and
initials in the form: date (mmddyy) - inspector's number -
inspection sequence - sample sequence - inspector's initials (e.g.
010101-82467-001-002-MP). All collateral labeling, including
circulars, and inner instruction sheets, shall be similarly identified.
Circulars that have been removed from the sample for
identification shall be reinserted into the original packages.
Additionally, when identifying larger size unit samples, unless
identical bin labels are not available, make a hand-written label for
each subsample that provides at least the following information for
the safety of those who will handle the sampled product: 1) brand
name of the product, 2) principal active ingredients and labeled
concentrations in percent, 3) company or name and address as
shown on label, 4) distinguishing marks or code numbers, and 5)
labels should be stamped in red ink with "poison" and skull and
crossbones if the product's label was so marked (poison labels must
also be affixed to the outside of the sample bag) and 6) the EPA
Registration Number if present.
The above instructions would also apply to all small-sized samples
that are wrapped and sealed in such a way as to obscure the
product's label. Copies of appropriate bin labels can be taped to
each container, if available, in lieu of the above information.
Identification of Documents
Records
All copies of sample records obtained at the establishment must be
identified in the inspector's handwriting with the sample number,
date, and the inspector's initials. This identification shall appear as
close to the upper right corner as possible.
Accompanying Literature, Labeling, Photographs, and Exhibits
This material shall be identified in the inspector's handwriting with
the sample number, date, and initials. Do not mark on the face of
photographs. All identification marks shall be on the border of the
photograph. Each photograph shall be identified as to which panel
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of label it represents (i.e., front panel, back panel, left side, or right
side panel, etc.). A photograph showing the entire label and its
placement on the container shall be submitted. If it is a black and
white photo, a notation of the color of the warning statement shall
be made on the photograph. The source of any accompanying
labeling or literature collected is to be identified in the Investigation
Summary Report (or equivalent narrative).
Physical Sample Custody
Samples are prepared by placing the sample (s) in an inverted clear
polyethylene bag (4 mil thickness), twisting the top of the bag to tie
a knot, turning the excess amount of bag over the knot, and taping
the excess bag below the knot. It is important that the sample label
be readable through the plastic bag. Each glass unit is to be sealed
in a separate bag. In addition to ensuring custody, the polyethylene
bag provides some degree of containment in case of breakage or
leakage.
Preparing the EPA Official Sample Seal
Physical samples are officially sealed by placing a completed EPA
Official Sample Seal (EPA Form 7500-2) (Exhibit 9-5) with the
signature of inspector, sample number, date, and name and title of
inspector printed. There is also space for a Regional Office
location to be noted on the form.
Applying the EPA Official Sample Seal
The Official Sample Seal is then placed just below the knot in the
poly-bag. The folded down portion of the poly-bag should be
twisted below the knot and perhaps be taped with masking tape or
mono-filament type tape below the knot to ensure closure. The
completed Official Sample Seal is then placed around the tape by
meeting both ends and applying pressure toward the knot to form
the Seal. If it becomes necessary to break an official seal, it is to be
removed from the bag and properly initialed and dated. The
broken seal is then mounted on a piece of paper and submitted
with the collection report to provide a continuous history. The
sample must then be officially reseated with a newly completed
EPA Official Sample Seal.
Sample Integrity and Sample Custody
Sample integrity and sample custody are initiated and documented
from the point of collection to the transfer of the physical sample
to the laboratory custodian. Sample integrity describes the securing
of the sample (both physical and documentary) and the placing of
the sample (s) under conditions that will not compromise their
chemical and/or physical integrity. Sample custody describes the
action of and formal documentation - chain of custody record -
on maintaining security and condition of the samples so that there
is absolutely no doubt in the validity of the evidence collected.
Following collection, documentation, and initiation of chain-of-
custody, samples must be stored in a secure area prior to transfer to
the laboratory. Pesticide product samples can be transferred to the
laboratory, in order of preference, either by: 1) direct personal
transfer, 2) common air or ground carrier (e.g., UPS, FedEx, motor
freight trucking company, etc.), or 3) U.S. Postal Service.
Chapter Nine • FIFRA Pesticide Product Sampling • 9-16
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FIFRA Inspection Manual, July 2002
Regardless of which method is employed for samples transfer,
several requirements need to be followed:
a) glass containers must never be packaged directly against each
other, either within the same plastic bag or within the shipping
container; b) the sample label, whether for a prepackaged unit or
for subsampled material, should always be readable through the
plastic bag; c) liquid samples should not be packaged with solids in
the same outer shipping container; d) a copy of the Investigation
Summary Report or equivalent form should be included with the
samples, protected in a protective bag or sleeve; and e) the
laboratory director or designee should be notified by telephone that
the samples are being shipped, the mode of transfer, and the
expected arrival date.
Mode of Transfer
Hand Delivery
Hand delivery to the laboratory is the preferable method of sample
transfer. The only requirements, beyond those mentioned
previously, are that 1) the transfer be accomplished in a timely
manner, 2) the sample be preserved, if necessary, and 3) all sample
transfers are documented on the custody record, or Chain-Of-
Custody Form (Exhibit 9-6). Other authorized individuals may act
as intermediates in transferring official samples to the testing
laboratory as long as all such transfers are fully documented with
respect to dates and signatures on the Chain-Of-Custody form.
Common Carrier
If pesticide formulation or related samples cannot be hand-
delivered to the laboratory, the services of a commercial shipping
or overnight package firm (either surface or air) are preferred over
use of the U.S. Postal Service for reasons of timeliness. However,
transportation by commercial means is tightly regulated by the U.S.
Department of Transportation (DOT) particularly concerning the
conveyance of hazardous materials, which includes many pesticides.
DOT requires that persons responsible for working with hazardous
materials (hazmat) must have hazmat training.
Because of the continuing changing nature of the DOT regulations,
in 40 CFR Parts 100 to 177, the pesticide inspector is advised to
obtain the latest edition of these regulations to ensure full
knowledge of pertinent additions and deletions. Many pesticides
are listed in the Hazardous Materials Table in 49 CFR 172.101, or
are listed according to their hazardous properties as being poisons,
oxidizers, corrosives, flammables, or pressurized gases.
In most cases the pesticide label can be used to identify the hazard
category, as the EPA Pesticide Registration Division classification
system is almost identical to that being used by DOT. The DOT
table cites the appropriate labeling, maximum quantity that can be
shipped per package, and specific CFR requirements and
exemptions for packaging. The Hazardous Materials table also
contains an appendix which gives the reportable quantities for
certain materials.
Chapter Nine • FIFRA Pesticide Product Sampling -9-17
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FIFRA Inspection Manual, July 2002
These are quantities that must be reported on the shipping papers,
if appropriate, to meet USEPA reportable release requirements.
For quick reference the following DOT documents have been
reproduced to assist the inspector in insuring compliance with
DOT regulations: 1) Hazardous Materials Definitions (Exhibit 9-7),
2) Guide for Shippers, Exhibit 9-8, 3) Guide for Hazardous
Materials Shipping Papers, (Exhibit 9-9).
The two major parcel service companies, United Parcel Service and
Federal Express, each have toll free numbers to assist the inspector
in the use of their services for transporting hazardous materials.
Federal Express 1-800-463-3339
United Parcel Service 1-800-322-1333
American Labelmark also has a toll-free number (800-621-5808) to
provide advice on shipping hazardous materials, as well as serving
as a source of packaging materials, containers, and labels. There are
many mail for profit firms which now provide similar services, such
as Mail Plus. They may be a source of materials for this work..
Pesticide formulations that do not fall under any of the hazardous
categories may be shipped as unrestricted. However, packaging
should at least meet the requirements of the DOT ORM-A
classification (49 CFR 173.505).
U.S. Postal Service
Except in emergencies, the U.S. mail should only be used to
transfer small quantities of nonhazardous solid pesticides
formulations to the laboratory, such as antimicrobial pesticides of
low concentration (below 5%). The mail service has not proven
reliable in the past to ensure safe and timely delivery on a sustained
basis. In addition, specific restrictions exist on the mailability of
poisons, flammables, oxidizers, and corrosives, which are spelled
out in the USPS Mailability of Hazardous Materials document
(Exhibit 9-10).
Chapter Nine • FIFRA Pesticide Product Sampling • 9-18
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FIFRA Inspection Manual, July 2002
Exhibit 9-1: Receipt for Samples (EPA Form 3540-3)
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
^•-"** RECEIPT FOR SAMPLES
NAME OF INDIVIDUAL TIT
FIRM NAME FIR
ADDRESS (EPA Regional Office)
DATE
LE
M ADDRESS (Number, Street, City, State, and ZIP Code)
SAMPLE NUMBERS
SAMPLES COLLECTED (Describe fully. List Registration, Lot, Batch, Model, Serial Numbers, and other positive identification)
The following samples were collected by the U.S. Environmental Protection Agency and receipt is hereby acknowledged
pursuant to Section 9(a) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. 136 g). This
section is quoted on the reverse of this form.
ACKNOWLEDGEMENT OF PRODUCER/REGISTRANT
The undersigned acknowledges that the samples shown above were obtained from pesticides or devices that were packaged,
labeled, and released for shipment.
SIGNATURE (Owner, Operator, or Agent) TIT
D DUPLICATE SAMPLES I — I DUPLICATE SAMPLES SA
REQUESTED AND PROVIDED 1 — 1 NOT REQUESTED
"LE (Owner, Operator, or Agent)
MPLESWERE rj puRCHASED [^BORROWED
AMOUNT PAID FOR SAMPLES
QCASH [^VOUCHER Q TO BE BILLED [~~| NO CHARGE
NAME OF COLECTOR (print or type) TITLE OF COLLECTOR
SIGNATURE OF COLLECTOR
EPA FORM 354O-3 (Rev. O1-O1)
PREVIOUS EDITION MAY BE USED
UNTIL SUPPLY IS EXHAUSTED
1. Original - ESTABLISHMENT COPY
2. EIR COPY
3. SAMPLE RECORD COPY
4. COLLECTOR'S COPY
Chapter Nine • FIFRA Pesticide Product Sampling -9-19
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FIFRA Inspection Manual, July 2002
Sec. 9. [136g] Inspection of Establishments, Etc
(a) In General.
(1) For purposes of enforcing the provisions of this Act, officers or employees of the Environmental Protection Agency or of any State
duly designated by the Administrator are authorized to enter at reasonable times:
(A) any establishment or other place where pesticides or devices are held for distribution or sale for the purpose of
inspecting and obtaining samples of any pesticides or devices, packaged, labeled, and released for shipment, and samples
of any containers or labeling for such pesticides or devices.
(B) any place where there is being held any pesticide the registration of which has been suspended or canceled for the
purpose of determining compliance with section 19.
(2) Before undertaking such inspection, the officers or employees must present to the owner, operator, or agent in charge of the
establishment or other place where pesticides or devices are held for distribution or sale, appropriate credentials and a written
statement as to the reason for the inspection, including a statement as to whether a violation of the law is suspected. If no violation is
suspected, an alternate and sufficient reason shall be given in writing. Each such inspection shall be commenced and completed with
reasonable promptness. If the officer or employee obtains any samples, prior to leaving the premises, the officer or employee shall
give to the owner, operator, or agent in charge a receipt describing the samples obtained and, if requested, a portion of each such
sample equal in volume or weight to the portion retained. If an analysis is made of such samples, a copy of the results of such analysis
shall be furnished promptly to the owner, operator, or agent in charge.
Chapter Nine • FIFRA Pesticide Product Sampling • 9-20
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FIFRA Inspection Manual, July 2002
Exhibit 9-2: Copy of Invoice and Shipping Record (EPA Form 3540-13)
UNITED STATES
f\ F"D/V ENVIRONMENTAL PROTECTION AGENCY
^Elrr\ COPY OF INVOICE AND SHIPPING RECORD
2. LOCATION 3.
INSPECTOR'S NAME
SECTION 1 - COPY OF INVOICE
5. SHIPPER (Name. Street. City, State, and ZIP code)
7. SOLD TO (Name, Street, City, State, and ZIP code)
9. INVOICE NO. 1O. INVOICE DATE
1. SAMPLE NO.
4. DATE COLLECTED
6. SHIPPED FROM
8. SHIPPED TO (If other than Item 7)
11. SHIPPED VIA
13. QUANTITY 14. UNIT SIZE IS. DESCRIPTION OF ARTICLE(S)
18. GUARANTEE
12. DATE OF SHIPMENT
16. UNIT PRICE 17. TOTAL
19.
TOTAL ^
SECTION II - COPY OF SHIPPING
2O. SHIPPER (Name. Street. City. State, and ZIP code)
21. SHIPPED TO
RECORD
(Name. Street, City, State, and ZIP code)
22. CARRIER {Name, Street, City, State, and ZIP code)
23. TYPE OF RECORD 24, RECORD NO.
28. SHIPPED FROM (City and State)
25. RECORD DATE
26. CAR OR EQUIPMENT NO. 27. WAYBILL DATE & NO.
31. DESCRIPTION OF ARTICLE(S)
36. RECEIVED BY 37. DATE REC'D
38. TOTALS
32. NO. PKGS
29. DATE SHIPPED 3O. OTHER CARRIERS
33. WEIGHT
34. RATE 3S. CHARGES
EPA FORM 354O-13 (Rov. O1-O1)
PREVIOUS EDITIONS MAY BE USED
Chapter Nine • FIFRA Pesticide Product Sampling • 9-21
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FIFRA Inspection Manual, July 2002
Exhibit 9-3: Dealer's Statement (EPA Form 3540-19)
&EPA
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
DEALER'S STATEMENT
DATE PREPARED SAMPLE NO
WHERE SAMPLE COLLECTED (City and State)
This certifies that the sample consisting of.
collected by Inspector.
.on.
was from shipment(s) received by us from.
on.
by.
and was identified to the Inspector
__^_ of this firm;
That the (copy of) invoicefs) No.
dated
and (copy of) shipping record(s) No._
dated
issued by.
which were identified by_
and furnished to the Inspector, cover this fthese) shipment(s).
REMARKS
PRICE PAID
s
CASH
VOUCHER
BILLED O
NO CHARGE C3
DEALER FIRM IName and Address)
SIGNATURE
EPA FORM 354O-19 (Rev. O1-O1)
PREVIOUS EDITIONS MAY BE USED
Chapter Nine • FIFRA Pesticide Product Sampling • 9-22
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FIFRA Inspection Manual, July 2002
Exhibit 9-4: Statement (EPA Form 3540-42)
&EPA
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
STATEMENT
SAMPLE NO.
STATE
07Y
1 hereby swear/affirm that the aforegoing statement is true to the best of my knowledge.
SIGNATURE
TITLE
INDIVIDUAL OR FIRM'S NAME AND ADDRESS (Include ZIP cndt and telephone number]
Subscribed and sworn to before me at (City and Slate) _
this day of __^ 20
SIGNATURE OF EPA REPRESENTATIVE
EPA FORM 354M2 (Rev. 07-01)
Chapter Nine • FIFRA Pesticide Product Sampling • 9-23
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FIFRA Inspection Manual, July 2002
Exhibit 9-5: EPA Official Sample Seal (EPA Form 7500-2)
/tDSr<^ UNITED STATES
„" A % ENVIRONMENTAL PROTECTION AGENCY
1 " i OFFICIAL SAMPLE SEAL
USB;
''^. ffioito
SAMPLE NO.
SIGNATURE
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L.
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0
Chapter Nine • FIFRA Pesticide Product Sampling • 9-24
-------
FIFRA Inspection Manual, July 2002
Exhibit 9-6: Chain of Custody Record (EPA Form 3540-41)
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Chapter Nine • FIFRA Pesticide Product Sampling • 9-25
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FIFRA Inspection Manual, July 2002
Exhibit 9-7: Hazardous Materials Definitions
The following definitions have been abstracted from the Code of Federal Regulations, Title 49, Transportation,
Parts 100-199. Refer to the referenced sections for complete details. Note: In column (1), 49 CFR 172.101,
Hazardous Materials Table, the (+) fixes the proper shipping name and hazard class. The name and class do not
change whether the material meets or does not meet the definition of that class. (49 CFR 172.101(b)(l)).
HAZARDOUS MATERIAL - A substance or material, including a hazardous substance, which has been
determined by the Secretary of Transportation to be capable of posing an unreasonable risk to health, safety, and
property when transported in commerce, and which has been so designated. (See 49 CFR 171.8).
MULTIPLE HAZARDS - A material meeting the definition of more than one hazard class and must be classed
according to its position on the list in 49 CFR 173.2(a). For example, a material that meets the definition of a
flammable liquid and an irritating material would be classed as a flammable liquid.
DOT
CLASS
HAZARD
UN CLASS
DEFINITION
EXPLOSIVES
An Explosive is any chemical compound, mixture, or device
which is designed to function by explosion, that is
substantially instantaneous with the release of gas and heat.
Exception-such compound, mixture, or device which is
otherwise specifically classified in 49 CFR Parts 171-180. (See
49 CFR 173.50)
EXPLOSIVES
CLASS A
Detonating. Maximum Hazard. The nine types of Class A
explosives are defined in 49 CFR 173.53.
EXPLOSIVES
CLASS B
Flammable Hazard. In general, functions by rapid combustion
rather than detonation. Included are explosive devices such as
special fireworks, flash powders, etc. (49 CFR 173.88)
EXPLOSIVES
CLASS C
Minimum hazard. Small arms ammunition, certain types of
fireworks and various types of manufactured articles
containing restricted quantities of Class A and/or Class 11
explosives as components. Included are common fireworks
and various types of small arms ammunition manufactured
articles which contain restricted quantities of Class A or Class
B explosives. (49 CFR 173.100)
BLASTING AGENT
Blasting Agent. A material designed for blasting which has
been tested in accordance with 49 CFR 173.114(a)(b). It must
be so insensitive that there is very little probability of: (1)
accidental explosion or (2) going from burning to detonation.
(49 CFR 173.114a(a))
GASES
Compressed Gas
Any material or mixture having in-the-container an absolute
pressure exceeding
Chapter Nine • FIFRA Pesticide Product Sampling • 9-26
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FIFRA Inspection Manual, July 2002
DOT
CLASS
HAZARD
UN CLASS
DEFINITION
GASES
Non-liquified Compressed
Gas
A gas (other than gas in solution) which, under the charged
pressure, is entirely gaseous at a temperature of 70'F. (49 CFR
173.300(c))
GASES
Liquefied Compressed
Gas
A gas which, under the charged pressure, is partially liquid at
a temperature of 70-F. (49 CFR 173.300(d))
GASES
Compressed Gas in
solution
A non- liquified compressed gas which is dissolved in a
solvent. (49 CFR 173.300(e))
GASES
Flammable
Compressed Gas
Any compressed gas meeting criteria as specified in 49 CFR
173.300(a) and (1)). This includes: lower flammability limit,
flammability limit range, flame projection, or flame
propagation.
Nonflammable Gas
Any compressed gas other than a flammable compressed gas.
FLAMMABLE LIQUID
Any liquid having a flash point below 100'F. Authorized
methods to determine flashpoints are listed in 49 CFR
173.115(d). For exceptions, see 49 CFR 173.115(a).
FLAMMABLE LIQUID
Pyrophoric Liquid
Any liquid that ignites spontaneously in dry or moist air at or
below 130'F. (49 CFR 173.115(c))
COMBUSTIBLE
LIQUID
Any liquid that does not meet any other hazard class, other
than ORM-E, having a flash point at or above 100'F. and
below 200'F. For exceptions, see 49 CFR 173.115(b).
Authorized methods to determine flashpoints are listed in 49
CFR 173.115(d). Exceptions are found in 49 CFR 173.118(a).
FLAMMABLE SOLID
Any solid material (other than an explosive) which under
normal transportation conditions is liable to cause fires
through friction or retained heat from manufacturing or
processing. It can, be ignited readily and burns so vigorously
and persistently, as to create a serious transportation hazard.
Included in this class are spontaneously combustible and water
reactive material. (49 CFR 173.150)
Chapter Nine • FIFRA Pesticide Product Sampling • 9-27
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FIFRA Inspection Manual, July 2002
DOT HAZARD
CLASS
UN CLASS
DEFINITION
FLAMMABLE SOLID
Spontaneously
Combustible Material
(solid)
A solid substance (including sludges and pastes) which may
undergo spontaneous Treating or self-ignition under normal
transportation conditions. These materials may increase in
temperature and ignite when exposed to air. (49 CFR 171.8)
FLAMMABLE SOLID
Water Reactive Material
(solid)
Any solid substance (including sludges and pastes) which react
with water by igniting or giving off dangerous quantities of
flammable or toxic gases. (49 CFR 171.8)
ORGANIC PEROXIDE
Any organic compound containingthe bivalent -0-0- structure.
It may be considered a derivative of hydrogen peroxide where
one or more of the hydrogen atoms have been replaced by
organic radicals. It must be classed as an organic peroxide
unless it meets certain criteria listed in 49 CFR 173.151(a).
OXIDIZER
A substance such as chlorate, permanganate, inorganic
peroxide, or a nitrate, that yields oxygen readily to stimulate
the combustion of organic matter. (49 CFR 173.151)
POISON A
Extremely Dangerous
Poisons, Poisonous gases
or liquids
A very small amount of the gas, or vapor of the liquid, mixed
with air is dangerous to life. (49 CFR 173.326)
POISON
Less Dangerous Poisons
Substances, liquid or solid (including pastes and semi-solids),
other than Class A Poisons or Irritating Materials—so toxic (or
presumed to be toxic) to man that they are a hazard to health
during transportation. (49 CFR 173.343(a))
IRRITATING
MATERIAL
A liquid or solid substance which, upon contact with fire or
air, gives off dangerous or intensely irritating fumes. It does
not include any poisonous material, Class A. (49 CFR 173.381)
ETIOLOGIC AGENT
A living micro- organism (or its toxin) which causes (or may
cause) human disease, and includes those agents listed in 49
CFR 72.3.(49 CFR 173.386)
RADIOACTIVE
MATERIAL
Any material, or combination of materials, that spontaneously
gives off ionizing radiation. It has a specific activity greater
than 0.002 microcunes per gram. (49 CFR 173.403)(See 49
CFR 173.403(a) through (z) for details.)
Chapter Nine • FIFRA Pesticide Product Sampling • 9-28
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FIFRA Inspection Manual, July 2002
DOT
CLASS
HAZARD
UN CLASS
DEFINITION
CORROSIVE
MATERIAL
A liquid or solid that causes visible destruction or irreversible
damage to human skin tissue on contact. Also, it may be a
liquid that has a severe corrosion rate on steel. (See 49 CFR
173.240 (a) and (b) for details.)
ORM-OTHER
REGULATED
MATERIALS
(1) Any material that may pose an unreasonable risk to health,
safety, and property when transported in commerce; and (2)
does not meet any of the definitions of the other hazard
classes specified in this subchapter, or (3) has been reclassed
an ORM (specifically or permissively) according to this
subchapter. (49 CFR 173.500(a))
ORM-A
Material which has an anesthetic, irritating, noxious, toxic, or
other similar property. If the material leaks during
transportation, passengers and crew would experience extreme
annoyance and discomfort. (49 CFR 173.500(b)(l))
ORM-B
A material, (including a solid when wet with water), the
leakage of which could cause significant damage to the vehicle
transporting it. Materials meeting one or both of the following
criteria are ORM-it materials: (1) specifically designated by
name in 49 CFR 172.101 and/or (2) a liquid substance that
has a corrosion rate exceeding 0.250 inch per yearfTPY) on
non-clad aluminum. An acceptable test is described in NACE
Standard TM-01-69.(49 CFR 173.500(b)(2))
ORM-C
A material which has other inherent characteristics not
described as an ORM-A or ORM-B, but which make it
unsuitable for shipment, unless properly identified and
prepared for transportation. Each ORM-C material is
specifically named in 49 CFR 172.101. (49 CFR 173.500(b) (3))
ORM-D
A material such as a consumer commodity which presents a
limited hazard during transportation due to its form, quantity
and packaging. It must be a material for which exceptions are
provided in 172.101. Shipping descriptions applicable to
ORM-D materials are found in 49 CFR 172.101. (49 CFR
173.500(b)(4))
ORM-E
A material that is not included in any other hazard class but is
subject to the requirements of this subchapter. Materials in
this class include: (1) HAZARDOUS WASTE and (2)
HAZARDOUS SUBSTANCES, as defined in 49 CFR 171.8.
(49CFR173.500(b)(5))
Chapter Nine • FIFRA Pesticide Product Sampling • 9-29
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FIFRA Inspection Manual, July 2002
THE FOLLOWING ARE OFFERED TO EXPLAIN SOME OF THE ADDITIONAL TERMS USED
IN PREPARATION OF HAZARDOUS MATERIALS FOR SHIPMENT. (49 CFR 171.8)
CONSUMER COMMODITY - A material that is packaged or distributed in a form intended or suitable for sale
through retail sales agencies. The material is for use by individuals for personal care or household use. This term
also includes drugs and medicines. (49 CFR 171.8).
FLASH POINT - The minimum temperature at which the flammable vapors of a substance (in contact with a
spark or flame) will ignite. For liquids, see 49 CFR 173.115. ],or solids, see 49 CFR 173.150.
FORBIDDEN - A material that is prohibited from being offered or accepted for transportation. This Prohibition
does not apply if these materials are diluted, stabilized, or incorporated in devices AND they are classed in
accordance with Part 173 of the subchapter. (See 49 CFR 172.101 (d)(l)).
HAZARDOUS SUBSTANCE - A material, including its mixtures and solutions, that: (1) is listed in the Appendix
to 172.101; (2) is in a quantity, in one package, which equals or exceeds the reportable quantity (RQ) listed in the
Appendix to 49 CFR 172.101; (3) when in a mixture or solution for radionuclides conform to the appendix to
172.101, Table 2 is in a concentration by weight, which equals or exceeds the concentration corresponding to the
RQ of the material as shown in the table of the 'hazardous substance" definition in 49 CFR 171.8. This definition
does not apply to petroleum products that are lubricants or fuels. (See 40 CFR 300.6.).
HAZARDOUS WASTE - Any material that is subject to the Hazardous Waste Manifest Requirements or the U.S.
Environmental Protection Agency specified in the CFR Tide 40, Part 262. For answers to questions regarding
EPA hazardous waste regulations, call 1- 800-424-9346 in Washington, DC.
LIMITED QUANTITY - The maximum amount of a hazardous material authorized for specific labeling and
packaging exceptions. Consult the section applicable to the particular hazard class. See 49 CFR 173.118,
173.118(a), 173.153,173.244, 173.306, 173.345, and 173.364.
Chapter Nine • FIFRA Pesticide Product Sampling • 9-30
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FIFRA Inspection Manual, July 2002
Exhibit 9-8: Guide for Shippers
USE OF GUIDE
This Guide is presented as an aid to shippers of hazardous materials. It does not contain or refer to all of the
DOT requirements for shipping hazardous materials. For specific details, refer to all of the DOT requirements
for shipping hazardous materials. For specific details, refer to the Code of Federal Regulations (CFR), Title 49,
Transportation, Parts 100-199.
The following is offered as a step-by-step procedure to aid in compliance with the applicable DOT Regulations.
STEP 1 - DETERMINE THE PROPER SHIPPING NAME
The shipper must determine the proper shippingname of the materials as listed in the Hazardous Materials Table,
49 CFR 172.101, Column (2).
STEP 2 - DETERMINE THE HAZARD CLASS OR CLASSES
A. Refer to the Table, 49 CFR 172.101, Column (3) and locate the hazard class of the material.
B. If more than one class is shown for the proper shipping name, determine the proper class by
definition.
C. If the materials have more than one hazard, classify the material based on the order of hazards in 49
CFR 173.2.
STEP 3 - SELECT THE PROPER IDENTIFICATION NUMBERS
A. Refer to the Table, 49 CFR 172.101, Column (3a) and select the Identification Number (ID) that
corresponds to the proper shipping name and hazard class.
B. Enter the ID number(s) on the shipping papers and display them, as required, on packagings, placards
and/or orange panels.
STEP 4 - DETERMINE THE MODE(S) OF TRANSPORT TO ULTIMATE DESTINATION
A. As a shipper, you must assure yourself that the shipment complies with various modal requirements.
B. The modal requirements may affect the following: (1) Packaging; (2) Quantity per Package; (3)
Marking; (4) Labeling; (5) Shipping papers; (6) Certification.
STEP 5 - SELECT THE PROPER LABEL(S) AND APPLY AS REQUIRED
A. Refer to the Table, 49 CFR 172.101, Column (4) for required labels.
B. For details on labeling refer to: (1) Additional Labels,(3) Packagings (Mixed or Consolidated), 49 CFR
172.404(a) and (b); (4)Packages Containing Samples, 49 CFR 172.402(h); (5) Radioactive Materials, 49
CFR 172.403; and, (6) Authorized Label Modifications, 49 CFR 172.405.
Chapter Nine • FIFRA Pesticide Product Sampling • 9-31
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FIFRA Inspection Manual, July 2002
STEP 6 - DETERMINE AND SELECT THE PROPER PACKAGES
A. Refer to the Table, 49 CFR 172.101, column 5(a) for exceptions and Column (5b) for specification
packagings.
Consider the followingwhen selecting an authorized package: Quantity per package; Cushioning material,
if required; Proper closure and reinforcement; Proper pressure; Outage; etc. as required.
B. If packaged by a prior shipper, make sure the packaging is correct and in proper condition for
transportation.
STEP 7 - MARK THE PACKAGING (INCLUDING OVERPACKS)
A. Apply the required markings (49 CFR 172.300); Proper shipping name and ID number, when
required (49 CFR 172.301); Name and address of Consignee or Consignor (49 CFR 172.306).
B. For details and other required markings, see 49 CFR 172.300 through 172.338.
STEP 8 - PREPARE THE SHIPPING PAPERS
A. He basic requirements for preparing shipping papers include: Proper Shipping name; Hazard class;
ID number, Total quantity; Shipper's certification; and emergency response telephone number.
B. Make all entries on the shipping papers using the information required and in proper sequence (49
CFR 172.202).
C. For additional requirements, see 49 CFR 172.200 through 172.205.
STEP 9 - CERTIFICATION
A. Each shipper must certify by printing (manually or mechanically) on the shipping papers that the
materials being offered for shipment are properly classified, described, packaged, marked and labeled,
and in proper condition for transportation according to the applicable DOT Regulations (49 CFR
172.204).
B. For surface shipments; see 49 CFR 172.204(a) and (b); for air shipments, see 49 CFR 172.204(c).
STEP 10 - LOADING, BLOCKING AND BRACING
When loading hazardous materials into the transport vehicle or freight container, each package must be loaded,
blocked and braced in accordance with the requirements for mode of transport.
A. If the shipper loads the freight container or transport vehicle, the shipper is responsible for the
proper loading, blocking, and bracing of the materials.
B. If the carrier does the loading, the carrier is responsible.
STEP 11 - DETERMINE THE PROPER PLACARD (S)
Each person who offers hazardous materials for transportation must determine that the placarding requirements
have been met.
A. For Highway, unless the vehicle is already correctly placarded, the shipper must provide the required
placard(s) and required ID number(s) (49 CFR 172.506).
B. For Rail, if loaded by the shipper, the shipper must placard the rail car if placards are required. (49
CFR 172.508)
C. For Air and Water shipments, the shipper has the responsibility to apply the proper placards.
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STEP 12 - HAZARDOUS WASTE/HAZARDOUS SUBSTANCE
A. If the material is classed as a hazardous waste or hazardous substance, most of the above steps will
be applicable.
B. Pertinent Environmental Protection Agency Regulations are found in the Code of Federal
Regulations, Title 40, Part 262.
AS A FINAL CHECK AND BEFORE OFFERING THE SHIPMENT FOR TRANSPORTATION,
VISUALLY INSPECT YOUR SHIPMENT. THE SHIPPER SHOULD ENSURE THAT EMERGENCY
RESPONSE INFORMATION IS ON THE VEHICLE FOR TRANSPORTATION OF HAZARDOUS
MATERIALS.
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Exhibit 9-9: Guide For Hazardous Materials Shipping Papers
USE OF GUIDE
This Guide is designed for in-house use when reviewing hazardous material shipping paper requirements.
However, this document should not be used to determine compliance with the
U.S. DOT Hazardous Materials Regulations (HMR).
DEFINITIONS
Shipping Paper - (49 CFR 171.8) A shipping paper is a shipping order, bill of lading, manifest, or other
shipping document serving a similar purpose and containing the information required by 49 CFR 172.202,
172.203 and 172.204.
Hazardous Waste Manifest - (40 CFR 262.20) A hazardous waste manifest is a document (shipping paper)
on which all hazardous waste is identified. A copy of the manifest must accompany each shipment of waste
from the point of pick-up to the destination. For waste shipments, the hazardous waste manifest satisfies
DOT shipping paper requirements, if all DOT requirements for shipping papers are met. (49 CFR 172.205)
SHIPPER'S RESPONSIBILITY (49 CFR 172.200(a))
The person offering a hazardous material for transport has the responsibility to Properly prepare the shipping
paper. (See also 49 CFR 173.22.)
GENERAL ENTRIES ON SHIPPING PAPERS (49 CFR 172.201)
Contents - When describing a hazardous material on a shipping paper, that description must conform to the
following requirements:
(1) When a hazardous material and other materials are both described on the same shipping paper,
the hazardous material description entries:
(a) Must be entered first, or
(b) Must be entered in a contrasting color (or highlighted in a contrasting color - for
reproduced copies of the shipping paper only), or
(c) Must be identified by the entry "X" placed before the proper shipping name in a column
captioned "IIM." The "X" may be replaced by "RQ" (Reportable Quantity), if appropriate.
(See Figure I on following page.)
(2) The required shipping description on the original shipping paper and all copies must be legible
and printed (manually or mechanically) in English.
(3) The required description may not contain any code or abbreviation, unless it is specifically
authorized or required, such as "UN," United Nations, "NA," North America, or "Ltd Qty," Limited
Quantity.
(4) A shipping paper may contain additional information concerning the material provided that the
information is not inconsistent with the required description. The additional information must be
placed after the basic description required by 49 CFR 172.202(a)(4).
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(a) When appropriate, the entries "IMO" or "IMO Class" may be entered immediately before
or immediately following the class entry in the basic description.
(b) If a material meets the definition of more than one hazard class, the additional hazard
class(es) may be entered after the hazard class in the basic description.
NOTE: The International Civil Aviation Organization (ICAO)issues the "Technical Instructions for the Safe
Transport of Dangerous Goods by Air" for the international transportation of goods by air.
The International Maritime Organization (IMO) issues the "International Maritime Dangerous Goods Code
(IMDG)" for the international transportation of hazardous materials by water.
The terms "dangerous goods" and "hazardous materials" are considered synonymous.
Name of Shipper - A shipping paper for a shipment by water must contain the name of the shipper.
Emergency Response Telephone Number - A shipping paper must contain an emergency response telephone
number, as required by 49 CFR, Subpart G of Part 172.
HAZARDOUS MATERIALS DESCRIPTION (49 CFR 172.202)
The shipping description of a hazardous material on a shipping paper must include the following information:
Proper Shipping Name - The name prescribed for material in 49 CFR 172.101 Hazardous Materials Table
or 172.102 Optional IIMT MAY NOT BE ABBREVIATED. (49 CFR 172.202 (a)(l)).
The Hazard Class of the Material - The class pre scribed for material in 49 CFR IIM Table 172.101orl72.102
Optional IIMT. (See 49 CFR 172.202(a)(2).)
The Identification Number-The number prescribed in the IIM Table 172.101 or 172,102 Optional table for
the material (preceded by "UN" or "NA," as appropriate). (49
CFR 172.202(a)(3))
The Total Quantity By Weight (net or gross, as appropriate) or volume, including the unit of measure, of the
hazardous material, except for empty packaging, cylinders of compressed gases, and packaging of greater
than 110 gallon capacity. (49 CFR (172.202 (a)(4))
Except as otherwise provided in the regulations, the basic description specified in 172.202 (a)(t),(2), and (3)
must be in the sequence shown. For example: "Acetone, Flammable liquid, UN 1090." (49 CFR 172.202(b)).
The total quantity of the material covered by one description must appear before or after (or both before and
after) the basic description. (49 CFR 172.202(c)).
(1) Abbreviations may be used to specify the type of packaging and units of measure of the total
quantity. For example: 10 ctns. Paint, flammable Liquid, UN 1263, 500 Ibs. (49 CFR
172.202(c)(l)).
(2) Type of packaging and destination marks may be entered in any appropriate manner before or
after the basic description. (49 CFR 172.202(c)(2)).
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ADDITIONAL DESCRIPTION REQUIREMENTS (49 CFR 172.203) (ALL MODES)
Exemptions - Each shipping paper issued in connection with shipment made under an exemption must bear
the notation "DOT-E" followed by the exemption number adjacent to the description to which the exemption
applies. (49 CFR 172.203 (a))
Limited Quantities - Descriptions for materials offered as "Limited Quantities" must include the words
"Limited Quantities" or "Ltd Qty" following the basic description. (49 CFR 172.203(b))
Hazardous Substances (49 CFR 172.203(c))
(1) If the proper shipping name (for a material that is a hazardous substance) does not identify the
hazardous substance by name, the following shall be entered, in parentheses, in association with the
basic description:
(a) Name of the hazardous substance from the Appendix to the 49 CFR 172.101 Hazardous
Materials Table, or
(b) For waste streams, the waste stream number (A "waste stream" is a hazardous waste
liquified, sludge, solid, gas] continuously generated from a manufacturing process. Such
waste will be listed in either 49) CFR 261.31 or 40 CFR stream number-), or
(c) For wastes exhibiting an EPA characteristic of ignitability, corrosivity, reactivity, or
EPA toxicity the letters "EPA" followed by the word "ignitability," "corrosivity,"
"reactivity," or "El" toxicity" or the corresponding "I)" number, as appropriate.
(2) The letters "RQ" (Reportable Quantity) shall be entered on the shipping paper either before or
afterthe basic description required by 49 CFR 172.202 for each hazardous substance.(See definition
in 49 CFR 171.8). Example: "RQ, Cresol, Corrosive UN 2076"; or "Hazardous Substance, Solid,
n.o.s., ORM-E, NA 9188 (Adipic Acid), RQ."
Radioactive Materials - For additional description requirements for radioactive materials, refer to 49 CFR
172.203(d).
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Exhibit 9-10: Mailability of Hazardous Materials
Summary
This document describes the standards, restrictions, and prohibitions for mailing hazardous materials, such as
explosives, gasses, flammable and combustible liquids, flammable solids, oxidizing substances, organic peroxides,
toxic and infectious substances, radioactive materials, and corrosives. It also provides information on package
markings, shipping papers, and warning labels. Note: Full responsibility rests with the mailer to comply with all
postal and nonpostal laws and regulations regarding the mailing of hazardous materials.
1.0 GENERAL
1.1 Definitions
The following definitions apply:
a. Hazardous materials any article or substance designated by the U.S. Department of Transportation (DOT) as
being capable of posing an unreasonable risk to health, safety, and property during transportation. In international
commerce, hazardous material is known as dangerous goods.
b. ]J.mited quantity is the maximum amount of a specific hazardous material that is exempted from the labeling or
packaging requirements in 49 CFR. Not every hazardous material is eligible to be shipped as a limited quantity.
c. ORM-D (Other Regulated Material) material is a limited quantity of a hazardous material that presents a limited
hazard during transportation due to its form, quantity, and packaging. In almost all instances, the proper shipping
name for an ORM-D material is consumer commodity. Not all hazardous material permitted to be shipped as a
limited quantity can qualify as an ORM-D material.
d. Consumer commodity is a hazardous material that is packaged and distributed in a quantity and form intended or
suitable for retail sale and designed for consumption by individuals for their personal care or household use
purposes. This term can also include certain drugs or medicines. Not all hazardous material permitted to be
shipped as a limited quantity can qualify as a consumer commodity.
e. Air transportation, for the purposes of this section only, applies to all mailable hazardous materials sent at First-
Class Mail, Priority Mail, or Express Mail rates (see 1.9).
f. Surface transportation, for the purposes of this section only, applies to all mailable hazardous materials sent at
Standard Mail rates.
' receptacle is the container (e.g., tube, vial, bottle) that holds the hazardous material.
h. Secondary packaging is the container into which a primary receptacle is placed.
i. Outer packaging is the container into which a primary receptacle and secondary packaging, together with
absorbent material and cushioning, are placed. The outer packaging bears the addressing information along with
all required markings.
1.2 U.S. Department of Transportation
The U.S. Department of Transportation regulates the surface and air carriage of Transportation hazardous
materials within the United States via any means of transportation. DOT regulations on hazardous materials are
codified in Title 49, Code of federal'Regulations (49 CFR), parts 100-185. Postal mailing standards for hazardous
materials adhere to 49 CFR and often include additional limitations and prohibitions.
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Generally, postal standards restrict the mailing of hazardous materials to ORM-D materials that meet the postal
volume limitations for the appropriate hazard class.
Exhibit 1.3 DOT Hazard Classes and Mailability Summary
Class
1
2
3
4
5
6
Hazard Class Name and Division (if
applicable)
Explosives
Division 1.1 Mass Explosive
Hazard
Division 1.2 Projection Hazard
Division 1.3 Fire Hazard
and/or Minor Blast/Minor
Projection Hazard
Division 1.4 Minor Blast Hazard
Division 1.5 Very Insensitive
With Mass Explosion Hazard
Division 1.6 Extremely Insensitive
With No Mass Explosion Hazard
Gases
Division 2. 1 Flammable Gases
Division 2.2 Nonflammable,
Nontoxic Gases Division 2.3
Toxic Gases
Flammable and Combustible
Liquids
Flammable Solids
Division 4. 1 Flammable Solids
Division 4.2 Spontaneously
Combustible Division 4.3
Dangerous When Wet
Oxidizing Substances, Organic
Peroxides
Division 5.1 Oxidizing
Substances Division 5.2 Organic
Peroxides
Toxic Substances and
Infectious Substances
Division 6.1 Toxic Substances
Division 6.2 Infectious Substances
Domestic Mail
Air
Transportation
Prohibited
Division 2. 1
and 2.3:
Prohibited
Division 2.2:
Only ORM-D
material
per 3.3
Flammable
liquids:
Prohibited
Combustibles:
Only ORM-D
material per
4.3
Prohibited
Only ORM-D
material per
6.2
Division 6.1:
Only ORM-D
material
per 7.2
Division 6.2:
Only per 8.0
Domestic Mail
Surface
Transportation
Prohibited
except
with written
permission as
allowed in 2.2
Divisions 2.1,
2.2:
Only
ORM-D
material per
3.3
Division 2.3:
Prohibited
Flammable
liquids: Only
ORM-D
material
per 4.2
Combustibles
Only
ORM-D
material per
4.3
Only
ORM-D
material per
5.2
Only
ORM-D
material per
6.2
Division 6.1:
Only
ORM-D
material
per 7.2
Division 6.2:
Only
per 8.0
International
Mail
Prohibited
Prohibited
Prohibited
Prohibited
Prohibited
Division 6.1:
Prohibited
Division 6.2:
Only
mailable
per IMM
135
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Class
7
8
9
Hazard Class Name and Division (if
applicable)
Radioactive Materials
Corrosives
Miscellaneous Hazardous Materials
Domestic Mail
Air
Transportation
Prohibited
Only in
ORM-D
material per
10.2
Only in
ORM-D
material per
11.0
Domestic Mail
Surface
Transportation
Only in limits
per
9.0 and
Publication
52
Only in
ORM-D
material per
10.2
Only in
ORM-D
material per
10.2
International
Mail
Only
mailable
in limits per
IMM 135
Prohibited
Only in
ORM-D
material per
10.2
1.3 Hazard Class
Every hazardous material is assigned to one of nine hazard classes identified in 49 CFR 172.101 and 173. Some
hazard classes are further separated into divisions based on their physical or chemical properties. For postal
purposes, Exhibit 1.3 generally summarizes the mailability of hazardous materials by hazard class.
1.4 Mailer Responsibility
Full responsibility rests with the mailer to comply with all postal and nonpostal laws and regulations regarding
the mailing of hazardous materials. Anyone who mails, or causes to be mailed, a nonmailable or improperly
packaged hazardous material can be subject to legal penalties, including but not limited to those specified in 18
use.
1.5 Mailability Rulings
Generally, the acceptability for mailing chemicals and other types of hazardous materials depends on container
fluid/vapor capacities, the ability of the complete package to contain the material, and the method of absorbing
and containing the product in case of accidental leakage of the primary receptacle. To determine mailability of
a specific material, a mailer must submit a material safety data sheet (MSDS) and the following information to the
appropriate rates and classification service center (RCSC):
a. Name of material, hazard class, and assigned United Nations (UN) or North America (NA) identification
number.
b. Chemical composition by percentage of ingredient.
c. Flashpoint.
d. Toxic properties.
e. Irritant action when inhaled, swallowed, or contacted by eyes or skin.
f. Special precautions necessary to permit handling without harm to USPS employees or damage to property or
other mail.
g. Explanation of warning labels and shipping papers required by State or federal regulations.
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h. Proposed packaging method, including the addressing and required markings.
i. Proposed number of pieces to be mailed, class of mail, and post office(s) of mailing.
1.6 Warning Labels
With few exceptions as noted in these standards, most hazardous materials acceptable for mailing fall within the
Other Regulated Materials (ORM-D) regulations of CFR 49 173.144, which do not require DOT hazard class
warning labels. Except for division 6.2 materials under 8.3 and dry ice under 11.4, any hazardous material bearing
or required to bear a DOT hazard class warning label under the requirements in 49 CFR is prohibited from
mailing. Mailable ORM-D material must be marked as required in 1.7. Mailable hazardous material must bear
DOT handling labels (e.g., orientation arrows, magnetized materials) when applicable.
1.7 Package Markings
Each mailpiece containing a mailable hazardous material must be plainly and durably marked on the address side
with the required shipping name and UN identification number. The UN identification number is not required
on a mailpiece that contains an ORM-D material. A mailable ORM-D material must be marked on the address
side with "ORM-D" or "ORM-D AIR," as applicable, immediately following or below the proper shipping name.
The proper shipping name for a mailable ORM-D material is consumer commodity. Mailable ORM-D material
sent via surface transportation must be marked on the address side as "Surface Mail Only."
1.8 Shipping Papers
For domestic surface transportation, a mailpiece containing a mailable hazardous material, except for an ORM-D
material or a specimen mailed under 8.4, must be accompanied by a shipping paper prepared under 49 CFR
172.200 through 172.205. For domestic air transportation, a mailpiece containing a mailable hazardous material,
except for a specimen mailed under 8.4, must be accompanied by a shipper's declaration for dangerous goods (i.e.,
shipping paper) completed and signed in triplicate by the mailer. The shipping paper must be affixed to the
outside of the mailpiece.
1.9 Air Transportation Prohibitions
All mailable hazardous materials sent at First-Class Mail, Priority Mail, or Express Mail rates are subject to the
limitations that apply to air transportation. The following types of hazardous materials are prohibited from
transport via aircraft:
a. Anything susceptible to damage or that can become harmful because of changes in temperature or atmospheric
pressures unless protected against the effects of such changes.
b. Magnetic materials that have a field strength sufficient to cause a compass deviation at a distance of 15 feet (4.6
meters) or more from any point on the outer packaging.
c. Flammable materials (gases, liquids, and solids).
d. Radioactive materials.
e. Materials excluded from air shipment by DOT regulations (49 CFR 1-185) or of the applicable State (country)
or air carrier operator variations. Certain restricted articles, as described in 49 CFR 100-185 and the operator
variations of the air carriers, may be accepted for air transportation if properly packaged. These articles must be
labeled and bear a shipper's declaration in triplicate, as required by 49 CFR 172.204, or must be marked according
to the air carrier's operator variations. Refer to the technical instruction of the International Civil Aviation
Organization (ICAO) for air carrier operator variations.
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2.0 EXPLOSIVES (HAZARD CLASS 1)
2.1 Definition
An explosive is any substance, article, or device that is designed to function by explosion (i.e., an extremely rapid
release of gas and heat) or that, by chemical reaction within itself, is able to function in a similar manner even if
not designed to function by explosion, unless the substance or article is otherwise classed under the provisions
in 49 CFR. Hazard class 1 has six divisions as shown in Exhibit 1.3. No further explanation of the six divisions
is provided in these standards because explosives are prohibited in the mail except as permitted in 2.2.
2.2 Mailability
Explosives are prohibited in international mail. Explosives are prohibited in the domestic mail via air
transportation. For domestic surface transportation, explosives are prohibited except for certain division 1.4 toy
propellant devices and safety fuses specifically approved by the Mail Preparation and Standards manager, USPS
Headquarters, before mailing. A mailable explosive must meet the packaging and marking requirements provided
with the Manager's approval. A shipping paper is required.
3.0 GASES (HAZARD CLASS 2)
3.1 Definition
Hazard class 2 consists of three divisions:
a. Division 2.1, Flammable Gases. A material that is a gas at 68*F (20*€) or less and 14.7 psi (101.3 kPa) of pressure.
Flammable gases also include materials that have a boiling point of 68*F (20*€) or less at 14.7 psi (101.3 kPa) and
that are ignitable at 14.7 psi ( 101.3 kPa) when in a mixture of 13% or less by volume with air or that have a
flammable range at 14.7 psi (101.3 kPa) with air of at least 12% regardless of the lower limit. These conditions
must be established in accordance with ASTM E681-85, Standard Test Method for Concentration Limits of
Flammability of Chemicals, or other approved equivalent method. The flammability of aerosols must be
determined using the tests specified in 49 CFR 173.306(i).
b. Division 2.2, Nonflammable, Ncmtoxic Gases. A material that does not meet the definition of division 2.1 or 2.3 and
exerts in its packaging an absolute pressure of 40.6 psia (280 kPa) or greater at 68*F (20*€).
c. Division 2.3, Toxic Gases. A material that is poisonous by inhalation and is a gas at 68*F (20*€) or less and a
pressure of 14.7 psi (101.3 kPa) or a material that has a boiling point of 68*F (20*€) or less at 14.7 psi (101.3 kPa).
3.2 Mailability
Gases are prohibited in international mail. Toxic gases in division 2.3 are prohibited in domestic mail. Flammable
gases in division 2.1 are prohibited in domestic mail via air transportation, but are permitted via surface
transportation if the material can qualify as an ORM-D material and meet the standards in 3.3 and 3.4.
Nonflammable gases in division 2.2 are generally permitted in the domestic mail via air or surface transportation
if the material can qualify as an ORM-D material and meet the standards in 3.3 and 3.4.
3.3 Container
An other-than-metal container of a mailable gas may be acceptable if the water capacity of the container is 4 fluid
ounces (7.22 cubic inches) or less per mailpiece and the container meets 49 CFR requirements. Mailable
nonflammable and flammable compressed gases are acceptable in metal inside containers that have a water
capacity up to 33.8 fluid ounces (1 liter or 61.0 cubic inches), depending on their internal pressure. A DOT 2P
container must be used if the internal pressure is from 140 to 160psigat 130*F (55*€). A DOT 20 container must
be used if the pressure is from 161 to 180 psig at 130*F (55*C). A container with an internal pressure over 180
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psig at 130*F (55*€) is prohibited from mailing. Mailable flammable compressed gases are restricted to 33.8 fluid
ounces (1 liter) per mailpiece. Mailable nonflammable compressed gases are permitted in individual 33.8 fluid
ounce (1 liter) containers that may be securely packed within a single mailpiece up to a weight of 66 pounds (30
kg) per 49 CFR 173.306.
3.4 Marking
For surface transportation, packages of mailable gases must be clearly marked on the address side with "Surface
Mail Only" and "ORM-D" immediately following or below the proper shipping name (consumer commodity).
For air transportation, packages must be plainly and durably marked on the address side with "ORM-D AIR"
immediately following or below the proper shipping name and must also bear a shipper's declaration for
dangerous goods.
4.0 FLAMMABLE AND COMBUSTIBLE LIQUIDS (HAZARD CLASS 3)
4.1 Definitions
The terms used in the standards that apply to hazard class 3 are defined as follows:
a. 'Flammable Squid means a liquid that has a flashpoint of not more than 141 *F (60.5*C), or any material in a liquid
phase that has a flashpoint at or above 100'F (38*C).
b. Combustible liquid means any liquid that does not meet the definition of any other hazard class and has a flash
point above 141*F (60.5*€) and below 200*F (93*€). Note: A flammable liquid with a flashpoint at or above
100'F (38*C) that does not meet the definition of any other hazard class may be reclassified as a combustible
liquid per 49 CFR 173.120(b).
4.2 Flammable Liquid Mailability
Flammable liquid is prohibited in international mail. Flammable liquid with a flashpoint of 20*F (-7*€) or below
is prohibited in domestic mail. Other flammable liquid is prohibited in domestic mail via air transportation but
is permitted via surface transportation if the material can qualify as an ORM-D material and meet the following
conditions as applicable:
a. The flashpoint is above 20*F (-7*€) but no more than 73*F (23•€); the liquid is in a metal primary receptacle
not exceeding 1 quart, or in another type of primary receptacle not exceeding 1 pint, per mailpiece; enough
cushioning surrounds the primary receptacle to absorb all potential leakage; the cushioning and primary receptacle
are packed within a securely sealed secondary packaging that is placed within a strong outer packaging; and each
mailpiece is plainly and durably marked on the address side with "Surface Mail Only" and "ORM-D" immediately
following or below the proper shipping name.
b. The flashpoint is above 73*F (23*C) but less than 100'F (38*€); the liquid is in a metal primary receptacle not
exceeding 1 gallon, or in another type of primary receptacle not exceeding 1 quart, per mailpiece; enough
cushioning surrounds the primary receptacle to absorb all potential leakage; the cushioning and primary receptacle
are placed within a securely sealed secondary packaging that is placed within a strong outer packaging; and each
mailpiece is plainly and durably marked on the address side with "Surface Mail Only" and "ORM-D" immediately
following or below the proper shipping name.
4.3 Combustible Liquid Mailability
Combustible liquid is prohibited in international mail. Combustible liquid is permitted in domestic mail if the
material can qualify as an ORM-D material and meet the following conditions as applicable:
a. For surface transportation, if the flashpoint is 100'F (38*€) but no more than 141*F (60.5*€); the liquid is in
a metal primary receptacle not exceeding 1 gallon, or In another type of primary receptacle not exceeding 1 quart,
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per mailpiece; enough cushioning surrounds the primary receptacle to absorb all potential leakage; the cushioning
and primary receptacle are packed in a securely sealed secondary packaging that is placed within a strong outer
packaging; and each mailpiece is plainly and durably marked on the address side with "Surface Mail Only" and
"ORM-D" immediately following or below the proper shipping name.
b. For surface or air transportation, if the flash point is above 141*F (60.5*€) but no more than 200*F (93*€);
the liquid is in a primary receptacle not exceeding 1 gallon per mailpiece; enough cushioning surrounds the
primary receptacle to absorb all potential leakage; the cushioning and primary receptacle are packed in a securely
sealed secondary packaging that is placed within a strong outer packaging; and each mail piece is plainly and
durably marked on the address side with "ORM-D" or "ORM-D AIR," as applicable, immediately following or
below the proper shipping name. Mailable material sent via surface transportation must be marked on the address
side as "Surface Mail Only." For air transportation, each mail piece must bear a shipper's declaration for
dangerous goods.
c. For air or surface transportation without restriction, if the flash point is above 200*F (93*€). Mailable
combustible liquids must be properly and securely packaged to prevent leakage.
4.4 Cigarette Lighters
A cigarette lighter equipped with an ignition element and containing fuel is a Class 3 flammable liquid. A cigarette
lighter that contains a flammable gas is classed as a division 2.1 flammable gas. A cigarette lighter containing either
flammable liquid or flammable gas is permitted only in domestic mail via surface transportation when all of the
following conditions are met:
a. The design of the lighter and its packaging are approved by the DOT Associate Administrator for Hazardous
Material Safety, per 49 CFR 173.21 (i) and 173.308; and a DOT Approval Number (T -Number) is issued.
b. The prospective mailer of the lighter submits to the appropriate RCSC manager a written request for
authorization to mail the lighter, accompanied by a legible photocopy of the official DOT notice conveying the
approval described in 4.4a and a specimen of the actual lighter, the packaging materials in which each lighter is
to be mailed, the number of mail pieces and mailing location; and the mailer receives from the RCSC manager
a letter approving the requested authorization for mailing.
c. When presented for mailing, the address side of the mailpiece containing the lighter prominently displays the
T -Number, the proper shipping name "Lighter for Cigarette," and the marking "Surface Mail Only"; all
preparation and packaging requirements in the RCSC manager's approval letter are met; and a legible photocopy
of the RCSC manager's approval letter accompanies the mailing.
5.0 FLAMMABLE SOLIDS (HAZARD CLASS 4)
5.1 Definitions
Hazard class 4 consists of three divisions:
a. Division 4. 1, Flammable Solids. Any solid material other than one classed as
an explosive that, under conditions normally incident to transportation, is likely to cause fires through friction or
retained heat from manufacturing or processing, or that can be ignited readily and, when ignited, burns so
vigorously and persistently as to create a serious transportation hazard.
b. Division 4.2, Spontaneously Combustible. A liquid or solid pyrophoric material that even in small amounts and
without an external ignition source can ignite within 5 minutes after coming in contact with air, or a self-heating
material that, when in contact with air and without an energy supply, is liable to self-heat.
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c. Division 4.3, Dangerous When Wet. A material that, by contact with water, is likely to become spontaneously
flammable or to give off flammable or toxic gas at a rate greater than 1 liter per kilogram of the material per hour.
5.2 Mailability
Flammable solids are prohibited in international mail. Flammable solids are prohibited in domestic mail via air
transportation. A flammable solid that can qualify as an ORM-D material is permitted in domestic mail via surface
transportation if the material is contained in a secure primary receptacle having a weight of 1 pound or less; the
primary receptacle(s) is packed in a strong outer packaging with a total weight of 25 pounds or less per mailpiece;
and each mail piece is plainly and durably marked on the address side with "Surface Mail Only" and "ORM-D"
immediately following or below the proper shipping name.
5.3 Matches
Matches are classified as flammable solids. Strike-anywhere matches are prohibited in international and domestic
mail. Safety matches (book, card, or strike-on-box) are prohibited in international mail, and in domestic mail via
air transportation, but are permitted in domestic mail via surface transportation if:
a. They do not ignite spontaneously under conditions normally incident to transportation or when subjected for
8 consecutive hours to a temperature of 220*F (93 •€).
b. They cannot be readily ignited by friction unless struck on their own or a similar box, card, or book.
c. They are tightly packed in a securely sealed inner packaging to prevent any shifting or movement that could
cause accidental ignition by rubbing against adjoining items. The inner packaging(s) is placed securely within an
outer container made of fiberboard, wood, or other equivalent material. Multiple inner packagings may be placed
in a single outer packaging. The address side of the mail piece is marked "Surface Mail Only" and "Book
Matches," "Strike-on-Card Matches," or "Card Matches," as appropriate. A shipping paper is required.
d. The gross weight of each mail piece is not more than 50 pounds.
6.0 OXIDIZING SUBSTANCES, ORGANIC PEROXIDES (HAZARD CLASS 5)
Hazard class 5 consists of two divisions:
a. Division 5.1, Oxidising Substances. A material that may, generally by yielding
oxygen, cause or enhance the combustion of other materials.
b. Division 5.2, Organic Peroxides. Any organic compound that contains oxygen in the bivalent structure and that
may be considered a derivative of hydrogen peroxide, where one or more of the hydrogen atoms have been
replaced by organic radicals.
6.1 Definition
Oxidizing substances and organic peroxides are prohibited in international mail. For domestic mail, a material that
can qualify as an ORM-D material is permitted via air or surface transportation. Liquid materials must be enclosed
within a primary receptacle having a capacity of 1 pint or less; the primary receptacle(s) must be surrounded by
absorbent cushioning material and held within a secondary leak-resistant container that is packed within a strong
outer packaging. Solid materials must be contained within a primary receptacle having a weight capacity of 1
pound or less; the primary receptacle(s) must be surrounded with cushioning material and packed within a strong
outer packaging. Each mailpiece may not exceed a total weight of 25 pounds. The address side of each mailpiece
must be plainly and durably marked with "ORM-D AIR" or "ORM-D," as applicable, immediately following or
below the proper shipping name.
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6.2 Mailability
A mailable class 5 material sent via surface transportation must be marked "Surface Mail Only" on the address
side. A mailable material sent via air transportation must bear a shipper's declaration for dangerous goods.
7.0 TOXIC SUBSTANCES (HAZARD CLASS 6, DIVISION 6.1)
7.1 Definitions
The terms used in the standards for division 6.1 material are:
a. Toxic substance is a poisonous material, other than a gas, that is known to be so toxic to humans as to cause
death, injury, or harm to human health if swallowed, inhaled, or contacted by the skin.
b. Oral toxicity applies to a liquid with a lethal dose (LD50) for acute oral toxicity of not more than 500 mg/kg or
a solid with an LD50 for acute oral toxicity of not more than 200 mg/kg that when administered by mouth is likely
to cause death within 14 days in half of the test animals.
c. Dermal toxicity applies to a material with an LD50 for acute dermal toxicity of not more than 1,000 mg/kg that
when administered by continuous contact with bare skin is likely to cause death within 14 days in half of the test
animals.
d. Inhalation toxicity applies to a dust or mist with a lethal concentration (LC50) for acute inhalation toxicity of not
more than 10 mg/L; or a saturated vapor concentration in air at 68*F (20*€) of more than one-fifth of the LC50
for acute toxicity on inhalation of vapors and with an LC50 for acute inhalation toxicity of vapors of not more than
5,000 mVm3; that when administered by continuous inhalation for 1 hour is likely to cause death within 14 days
in half of the test animals.
e. Irritating material K any liquid or solid substance (e.g., tear gas) that gives off intense fumes and causes extreme
irritation and impairment to a person's ability to function.
7.2 Mailability
Toxic substances or poisons are prohibited in international mail. For domestic mail, a division 6.1 toxic substance
or poison that can qualify as an ORM-D material is permitted when packaged under the applicable requirements
in 7.4. Certain other poisonous materials are permitted to be mailed only between the authorized parties and
under the conditions in 7.3.
7.3 Authorized Parties
A division 6.1 toxic substance having an LD50 for oral toxicity of greater than 5mg/kgbut less than or equal to
50 mg/kg is mailable only if packaged under the applicable requirements in 7.4 and when sent between authorized
parties and under specified conditions, as follows:
a. Toxic substances for scientific use (not outwardly or of their own force dangerous or injurious to life, health,
or property) may be sent only between manufacturers, dealers, bona fide research or experimental scientific
laboratories, and employees of federal, state, or local governments who have official use for such poisons and are
designated by the agency head to receive or send such poisons. For air transportation, a shipper's declaration for
dangerous good is required.
b. Poisonous drugs and medicines may be sent only from the manufacturer or dealer of the drugs and medicines
to licensed physicians, surgeons, dentists, pharmacists, druggists, cosmetologists, barbers, and veterinarians (18
USC 1716).
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7.4 Packaging and Marking
The following requirements must be met, as applicable:
a. A toxic substance that can qualify as an ORM-D material and does not exceed a total capacity of 8 ounces per
mailpiece is permitted if: the material is held in an inner receptacle (s); enough cushioning material surrounds the
primary receptacle to absorb all potential leakage; the cushioning and primary receptacle (s) are packed in another
securely sealed secondary packaging that is placed within a strong outer packaging. Each mail piece must be
plainly and durably marked on the address side with "ORM-D" or "ORM-D AIR," as applicable, immediately
following or below the proper shipping name. Mailable material sent via surface transportation must be marked
on the address side as "Surface Mail Only."
b. Other toxic substances and poisons are permitted to be sent between the authorized parties and under the
conditions in 7.3 when they do not exceed 8 ounces per mailpiece and if: the material is held in a leak-resistant
primary receptacle (s); sufficient absorbent and cushioning material completely surround each primary receptacle;
the primary receptacle(s) and the absorbent and cushioning materials are firmly held within a secondary leakproof
(for liquids) or siftproof (for solids) packaging; the secondary packaging is firmly and securely held within a strong
outer packaging of 200-pound grade corrugated fiberboard or equivalent strength. The address side of each
mailpiece must be marked with the proper shipping name and UN (or NA) identification number of the material
(unless exempted by CO24.11.2). Mailable materials sent via surface transportation must be marked on the
address side as "Surface Mail Only." Each mailpiece must bear a shipping paper.
7.5 Irritating Material
Irritants are prohibited in international mail and domestic mail.
8.0 INFECTIOUS SUBSTANCES (HAZARD CLASS 6, DIVISION 6.2)
8.1 General
Infectious substances (i.e., etiologic agents), clinical specimens, and biological products are not permitted in
international mail or domestic mail, except when they are intended for medical or veterinary use, research, or
laboratory certification related to public health; and when it is determined that such items are properly prepared
for mailing to withstand shocks, pressure changes, and other conditions incident to ordinary handling in transit.
Mailable infectious substances sent as international mail must meet the standards in International Mail Manual
(IMM) 135. For domestic mail, mailable infectious substances must meet the applicable standards in 8.0.
8.2 Definitions
The terms used in the standards for division 6.2 material are:
a. Infectious substance (etiologic agent) means a viable microorganism, or its toxin, that causes or may cause disease
in human beings or animals, and includes those agents listed in 42 CFR 72.3 and any other agent that causes or
may cause severe, disabling, or fatal disease. The terms infectious substance and etiologic agent are synonymous.
b. Clinical (diagnostic) specimen means any human or animal material including, but not limited to, excreta, secreta,
blood, blood components, tissue, and tissue fluids, collected and being shipped for purposes of diagnosis.
c. biological product means a material derived from a living organism that is prepared and manufactured in
accordance with 9 CFR 102-104 (licenses for biological products; experimental products, distribution, and
evaluation prior to licensing; and permits for biological products), 21 CFR 312 (investigational new drug
application), or 21 CFR 600-680 (biologies) and that, under such provisions, may be shipped in interstate
commerce. Biological products include, but are not limited to, products such as vaccines.
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d. Sharps means any item of medical waste having a projecting cutting edge or fine point that was used in animal
or human patient care or treatment or in medical research or industrial laboratories. The term includes, but is not
limited to, hypodermic needles, syringes (with or without the attached needles), pasteur pipettes, scalpel blades,
blood vials, needles with attached tubing, and culture dishes (regardless of the presence of infectious agents). Also
included are other types of broken or unbroken glassware that were in contact with infectious agents, such as used
slides or cover slips. The term does not include new unused medical devices such as hypodermic needles, syringes,
and scalpel blades.
e. Other medical devices means all materials or devices used in animal or human patient care or treatment or in
medical research that are not, or do not contain, a projecting sharp and are not known or not reasonably believed
to contain an infectious substance (etiologic agent).
c 3 Packaging Infectious Substances (Etiologic Agents)
Packaging for all infectious substances (etiologic agents) is subject to these standards:
a. All infectious substances, clinical specimens, and biological product known or reasonably believed to contain
an etiologic agent must meet the packaging requirements of 42 CFR 72.3 and must not exceed 50 ml per
mailpiece. The primary receptacle or the secondary packaging must be capable of withstanding, without leakage,
an internal pressure that produces a pressure differential of not less than 14 psi (95 kPa) and temperature in the
range of -40«F to 131*F (-40*€ to 55*€) as required by 49 CFR 173.196.
b. The material must be packaged in a securely sealed and watertight primary receptacle (test tube, vial, etc.) that
is enclosed in another securely sealed, watertight, and durable secondary packaging. Several primary receptacles
may be enclosed in a single secondary packaging if there is adequate shock-absorbent material between them to
prevent breakage during ordinary handling and if the total liquid volume of all enclosed primary receptacles does
not exceed 50 ml.
c. The space between the primary receptacle(s) and the secondary packaging at the top, bottom, and sides must
contain enough material to absorb the entire content of the primary receptacle(s) in case of breakage or leakage.
d. The primary receptacle(s) and the secondary packaging must be enclosed in an outer packaging constructed
of fiberboard or other equivalent material. No external surface of the outer packagingmay be less than 3.9 inches
(100 mm) as required by 49 CFR 173.196.
e. Each mailpiece must be designed and constructed so that, if it were subject to the environmental and test
conditions in 49 CFR 178.609, there would be no release of the content to the environment and no significant
reduction in the effectiveness of the packaging.
f. The address side of the mailpiece must bear the "Etiologic Agents/Biohazard Material" label required by 42
CFR 72.3(d) and must be sent by Express Mail, Priority Mail, or First-Class Mail. Those specific etiologic agents
listed in 42 CFR 72.3 (f) must be sent registered mail. Each mailpiece must be marked on the address side with
the proper shipping name and UN number of the material (e.g., "Infectious Substances Affecting Humans,
UN2814," or "Infectious Substances Affecting Animals, UN2900"). Each mailpiece must bear a DOT Class 6
label for infectious substances (etiologic agents), proper UN package specification markings, and orientation
markings.
g. Articles that include dry ice as a refrigerant for the infectious substance must meet the requirements of 42 CFR
72.3(c) and 49 CFR 173.196(e)(2)(ii).
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8.4 Packaging Clinical Specimens and Biological Products
A clinical specimen or biological product known or reasonably believed to contain an infectious substance
(etiologic agent) must be packaged under 8.3. The packaging of a clinical specimen (e.g., a urine or blood
specimen used in drug-testing programs or for insurance purposes) or a biological product (e.g., polio vaccine)
that is not known or not reasonably believed to contain an infectious substance (etiologic agent) is subject to these
packaging standards:
a. Not Exceeding 50 ml. A clinical specimen or biological product consisting of 50 ml or less per mail piece must
be packaged in a securely sealed primary receptacle. Sufficient shock-resistant material to withstand shock and
pressure changes and absorbent material must surround the primary receptacle, or be otherwise configured to take
up the content in case of leakage. The primary receptacle and the absorbent cushioning must be enclosed in a
secondary packaging having a leakproof barrier that can prevent failure of the secondary packaging should there
be leakage of the primary receptacle during shipment. The secondary packagingmay serve as the outer packaging.
b. Exceeding 50 ml. In addition to meeting the requirements in 8.4a, a clinical specimen or biological product that
exceeds 50 ml per mail piece also is subject to these requirements:
(1) A single primary receptacle must not contain more than 1,000 ml of specimen; two or more primary
receptacles whose combined volume does not exceed 1,000 ml may be enclosed in a single secondary packaging.
(2) The secondary packaging cannot serve as the outer packaging; the secondary packaging must be enclosed in
a fiberboard box or container of equivalent strength; the maximum amount of a specimen that may be enclosed
in a single outer packaging must not exceed 4,000 ml.
c. Markings. Mailable material must be marked as specified in 8.7.
8.5 Sharps
The types of used sharps waste defined in 8.2d are permitted for mailing only using merchandise return service
(see 8923) in conjunction with First-Class Mail or Priority Mail, subject to these standards:
a. Authorisation. Each distributor or manufacturer of a complete sharps mailing
kit or packaging assembly, including containers, cartons, and any other related material to be used to mail sharps
to a storage or disposal facility, must obtain authorization from the U8P8. Before applying for authorization, each
type of mailing kit must be tested and certified against the standards in 8.5d by an independent party. A written
request for authorization is sent to the Mail Preparation and Standards manager, U8P8 Headquarters (see G043
for address). The request must contain the following:
(1) A $50,000 surety bond or letter of credit as proof of sufficient financial responsibility to cover disposal costs
if the manufacturer (or distributor) ceases doing business before all its shipping containers are disposed of, or to
cover cleanup costs if spills occur while the containers are in U8P8 possession.
(2) Address of the headquarters or general business office of the distributor or manufacturer.
(3) Address of each disposal and storage site.
(4) List of all types of mailing kits to be covered by the request, a complete sample of each mailing kit, and proof
of package testing certifications performed by the independent testing facility that subjected the packaging
materials to the testing requirements in 8.5d.
(5) Copy of the proposed manifest to be used with all mailings. (6) 24-hour telephone number for emergencies.
(7) List of the types of sharps waste to be mailed for disposal.
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b. Packaging. The packaging for used sharps waste and unsterilized containers is subject to these standards:
(1) Used sharps waste must be packaged in a securely sealed, leak-resistant, and puncture-resistant primary
receptacle that may not contain more than 50 ml of residual waste liquid. The primary receptacle must maintain
its integrity when exposed to temperatures between O'^and 120*F.
(2) The primary receptacle must be packaged within a watertight secondary packaging or containment system. The
secondary packaging may consist of more than one component. If one of the components is a plastic bag, it must
be at least 3.0 mils thick end reinforced with a fiberboard sleeve having a minimum thickness of 40-point. A
plastic bag by itself does not meet the requirement for a secondary packaging. Several primary receptacles may
be enclosed in a secondary packaging.
(3) The secondary packaging must be enclosed in an outer packaging or shipping container constructed of 200-
pound grade corrugated fiberboard or similar material of equivalent strength. The secondary packaging must fit
securely within the outer packaging to prevent breakage during ordinary processing.
(4) There must be enough material within a watertight barrier to absorb and retain three times the total liquid
allowed within the primary receptacle (150 ml per primary receptacle) in case of leakage.
(5) Each mailpiece must not weigh more than 35 pounds.
(6) In each sharps mailing kit, the manufacturer or distributor must include a step-by-step instruction sheet that
clearly details the proper sequence and methods of kit assembly prior to mailing to prevent package failure during
transport due to improper assembly.
c. Package documentation, marking, and labeling.
(1) Each primary receptacle and outer packaging must bear a label, which cannot be detached intact, showing: (a)
company name of the manufacturer or the distributor; (b) U.S. Postal Service Authorization Number; and (c)
container ID number (or unique model number) signifying that the packaging material is certified and the
manufacturer or distributor obtained an authorization required by 8.5a.
(2) The outer packaging must bear the international biohazard symbol in black with either a fluorescent orange
or fluorescent red background as shown in Exhibit 8.5c(2).
Exhibit 8 5c(2} International Biohazard Symbol
Fluorescent Orange or Red Background
Black
(3) All mail pieces containing used sharps must be accompanied by a four-part manifest or mail disposal service
shipping record. The manifest must be placed in an envelope affixed to the outside of the mailpiece. The manifest
must comply with all applicable requirements imposed by the laws of the State from which the package is mailed.
At a minimum, the information shown in Exhibit 8.5c(3) must be on the manifest.
(4) The outer packaging must bear a properly prepared merchandise return service label (see 8923).
(5) Mailable material must be marked as specified in 8.7.
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d. Package testing. Testing must be performed on one sample of each type of kit to prove compliance with 8.5a.
The sample packaging kit must withstand the tests in 49 CFR 178.604 (leakproof test), 178.606 (stacking test),
178.608 (vibration standard), and 178.609 (test requirements for packaging for infectious substances/etiologic
agents). In addition, the outer packaging must be subjected to the bursting test in 49 CFR 178.609(h)(2) and an
absorbency test for the absorbent material commensurate with the requirements in 8.5b(4) must be performed.
The test results must show that if every packaging kit prepared for mailing were to be subject to the
environmental and test conditions in 49 CFR, there would be no release of the contents to the environment and
no significant reduction in the effectiveness of the packaging. Periodic retesting must be performed whenever a
change is made to the packaging design or every 24 months, whichever occurs first.
Exhibit 8.5c(3) Manifest for Sharps Containers
1. Generator (Mailer)
a. Name.
b. Complete address (not a post office box).
c. Telephone number.
d. Description of contents of shipping container. "Used Medical Sharps" is required.
e. Date shipping container was mailed.
f. State permit number of approved facility in which contents are to be disposed.
2. Destination Facility (Disposal Site)
Complete address (not a post office box).
3. Generator's (Mailer's) Certification
"I certify that this carton has been approved for the mailing of used medical sharps, has been prepared for mailing in accordance with the
directions for that purpose, and does not contain excess liquid or nonmailable material in violation of the applicable postal regulations. I AM
AWARE THAT FULL RESPONSIBILITY RESTS WITH THE GENERATOR (MAILER) FOR ANY VIOLATION OF 18 USC 1716 WHICH MAY
RESULT FROM PLACING IMPROPERLY PACKAGED ITEMS IN THE MAIL. I also certify that the contents of this consignment are fully and
accurately described above by proper shipping name and are classified, packed, marked, and labeled, and in proper condition for carriage by air.
according to the applicable national governmental regulations."
This printed statement is to be followed by printed name of generator (mailer), signature of generator, and date when manifest was signed.
4. Destination Facility (Storage or Disposal Site)
a. Printed certification of receipt, treatment, and disposal stating: "I certify that the contents of this
package have been received, treated, and disposed of in accordance with all local, state, and federal regulations."
b. Printed or typewritten name of an authorized recipient at destination facility.
c. Signature of authorized recipient at destination facility.
d. Date representative of destination facility signed manifest.
5. Transporter or Intermediate Handler Other Than U.S. Postal Service (If Different From Destination Facilitay)
a. Name.
b. Complete street address (not a post office box).
c. Printed name of transporter or intermediate handler.
d. Signature of transporter or intermediate handler.
6. Serialized Manifests
Manifest or mail disposal service shipping forms must be serialized.
7. Area Reserved for Comments
Manifest must contain an area designated for entering discrepancies and comments, especially if an alternative destination facility is used.
8. Completion and Distribution of Manifest
Manifest must contain instructions for properly completing manifest and distributing copies.
a. One copy must be kept by generator (mailer).
b. One copy must be kept by transporter or intermediate handler for 90 days.
c. One copy must be kept by destination facility for 90 days.
d. One copy must be mailed to generator by destination facility.
9. Emergency Telephone Number
Manifest must bear following statement with appropriate information:
"IN CASE OF EMERGENCY, OR THE DISCOVERY OF DAMAGE OR LEAKAGE, CALL 1-800-XXX-XXXX."
8.6 Other Used Medical Devices
USPS authorization is not required to mail other used medical devices and waste as defined in 8.2e. Packaging
for other used medical devices is subject to these standards:
a. Other used medical devices must be mailed as First-Class Mail, Priority Mail, or Express Mail.
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b. Other used medical devices must be packaged in a securely sealed, leak-resistant primary receptacle, the total
liquid volume of which must not exceed 50 ml unless the devices are shipped in formalin or its equivalent. The
primary receptacle must maintain its integrity when exposed to temperatures between 0"and 120*F.
c. The primary receptacle must be enclosed in an outer packaging constructed of 200-pound grade corrugated
fiberboard or similar material of equivalent strength. The primary receptacle must fit securely within the outer
packaging to prevent breakage during ordinary processing.
d. There must be enough absorbent material and secondary leakproof material between the primary receptacle
and the outer packaging to absorb three times the total liquid allowed. If the device is mailed in a formalin
solution or its equivalent, there must be enough absorbent material and secondary leakproof material to absorb
the entire liquid contents in case of leakage.
e. Each parcel containing other used medical devices must bear a complete street return address (not a post office
box) and cannot exceed 35 pounds.
f. Mailable material must be marked as specified in 8.7.
8.7 Marking and Labeling of Division 6.2 Material
All mailable division 6.2 materials, except those prepared under 8.4, must be sent via air transportation. The
following markings and labels are required, as applicable:
a. Infectious Substances (Etiologic-Agents)'. Materials mailable under 8.3 must be marked and labeled as specified in 8.3f
A shipper's declaration for dangerous goods is required.
b. Clinical Specimens and Biological Products. Materials mailable under 8.4 must be marked on the address side with
"Clinical Specimen-Blood . Sample," "Clinical Specimen-Urine Sample," "Clinical Specimen-Saliva Sample,"
"Biological Product," etc., as appropriate. The universal biohazard symbol shown in Exhibit 8.5c(2) may appear
on the address side. A shipping paper is not required for material sent under 8.4.
c. Sharps Wastes. Parcels containing sharps waste mailable under 8.5 must be marked on the address side with the
proper shippingname and correct UN number (e.g., "RegulatedMedical Waste-Sharps, UN 3291"). The universal
biohazard symbol shown in Exhibit 8.5c(2) must appear on the outside of the mailpiece. The manifest required
in 8.5c serves as the shipping paper.
d. Other Used Medical Devices. Parcels containing other used medical devices mailable under 8.6 must be marked
on the address side with the proper shippingname and correct UN number (e.g., "Regulated Medical Waste, UN
3291"). The universal biohazard symbol shown in Exhibit 8.5c(2) must appear on the outside of the mailpiece.
A shipping paper is required.
9.0 RADIOACTIVE MATERIALS (HAZARD CLASS 7)
Radioactive materials are prohibited in international mail and domestic mail if required to bear the DOT
Radioactive White-I, Radioactive Yellow-II, or Radioactive Yellow-Ill label (49 CFR 172.436,172.438, or 172.440,
respectively) or if it contains quantities of radioactive material in excess of those authorized in Publication 52,
Acceptance of Hazardous, Restricted, or Perishable Matte/: Radioactive materials are prohibited in domestic mail via air
transportation. For international mail, the standards in IMM 135 apply.
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10.0 CORROSIVES (HAZARD CLASS 8)
10.1 Definition
A corrosive is any liquid or solid that causes visible destruction or irreversible alteration in human skin tissue at the
site of contact or a liquid that has a severe corrosion rate on steel.
10.2 Mailability
Corrosives are prohibited in international mail. A corrosive that can qualify as an ORM-D material is permitted
in domestic mail via air or surface transportation subject to these limitations:
a. Liquid Corrosive. A liquid mixture must be 1 pint or less and must contain 15% or less corrosive material with
the remainder of the mixture not being a hazardous material, unless otherwise specified for a specific corrosive
material. Primary receptacles must be securely sealed compatible glass bottles that are enclosed within securely
sealed metal or plastic secondary packagings. The secondary packaging must be packed within a strong outer
packaging that does not exceed 25 pounds per mail piece.
b. Solid Corrosive. A solid mixture must be 10 pounds or less per primary receptacle and must contain 10% or less
corrosive material with the remainder of the mixture not being a hazardous material, unless otherwise specified
for a specific corrosive solid. The primary receptacle(s) and secondary packaging must be securely sealed
compatible siftproof containers packed in strong outer packaging. The total weight of a mailable solid corrosive
cannot exceed 25 pounds per mail piece.
10.3 Marking
For surface transportation, the mailpiece must be plainly and durably marked on the address side with "Surface
Mail Only" and "ORM-D" immediately following or below the proper shipping name. For air transportation, the
mailpiece must be plainly and durably marked on the address side with "ORM-D AIR" immediately following
or below the proper shipping name and must bear a shipper's declaration for dangerous goods.
10.4 Nonspillable Wet Electric Storage Batteries
A battery containing liquid electrolyte is prohibited from mailing unless the battery casing is completely sealed
to prevent the liquid corrosive from spilling during handling. Nonspillable batteries with UN2800 are prohibited
in international mail, but may be sent as domestic mail via air or surface transportation under the following
conditions:
a. The nonspillable battery must be protected from short circuits and securely packaged in a strong fiberboard
box.
b. The outer packaging must be marked "NONSPILLABLE BATTERY, UN2800" on the address side.
c. The nonspillable battery must be capable of withstanding the vibration and pressure differential tests cited in
49CFR173.159(d)(i)and(ii).
d. Only one nonspillable battery is allowed per mailpiece and the weight of the mailpiece cannot exceed 50
pounds.
11.0 MISCELLANEOUS HAZARDOUS MATERIALS (HAZARD CLASS 9)
11.1 Definition
A miscellaneous hazardous material'^ a substance or article that presents a hazard during transportation but does not
meet the definition of any other hazard class. Examples of miscellaneous hazardous materials (not all of which
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are mailable) include solid dry ice, magnetized materials, elevated temperature substances, environmentally
hazardous substances, life-saving appliances, and asbestos.
11.2 Mailability
A miscellaneous hazardous material is prohibited in international mail. A miscellaneous hazardous material that
can qualify as an ORM-D material is permitted for domestic mail via air or surface transportation, subject to the
applicable 49 CFR requirements.
11.3 Marking
For surface transportation, the mailpiece must be plainly and durably marked on the address side with "Surface
Mail Only" and "ORM-D" immediately following or below the proper shipping name. For air transportation, a
mailable material must be plainly and durably marked on the address side with "ORM-D AIR" immediately
following or below the proper shipping name and bear a shipper's declaration for dangerous goods.
11.4 Dry Ice
Dry ice ( carbon dioxide solid) is prohibited in international mail. Dry ice is permitted in the domestic mail via
air or surface transportation when used as a refrigerant to cool the contents of a mail piece. A mailpiece containing
dry ice must be packed in a container that is designed to permit the release of carbon dioxide gas and prevent a
build-up of pressure that could rupture the parcel. Containers must conform to 49 CFR 173.217 and
175.10(a)(13). Additionally, the following applies:
a. Air Transportation. Each mail piece may not contain more than 5 pounds of dry ice. The address side of each
mailpiece must be clearly marked "Carbon Dioxide Solid, UN1845" or "Dry Ice, UN1845" along with the net
weight of the dry ice and the identity of the contents being cooled. A shipper's declaration prepared in triplicate
and a DOT Class 9 warning label for miscellaneous hazardous materials must be affixed to the outside of the
mailpiece.
b. Surface Transportation. The amount of dry ice per mailpiece may exceed 5 pounds. The address side of each
mailpiece must be clearly marked "Carbon Dioxide Solid" or "Dry Ice" and "Surface Mail Only" along with the
net weight of the dry ice and the identity of the contents being cooled. A shipper's declaration and a DOT Class
9 warning label is not required for the dry ice.
11.5 Magnetized Materials
A magnetized material is a hazard class 9 material subject to these limitations:
a. Definition. A magnetized material is an article that has a magnetic field strength capable of causing the deviation
of aircraft instruments. Magnetized materials include magnets and magnetized devices such as magnetrons and
light meters of sufficient strength to possibly cause erroneous aircraft compass readings.
b. Mailability. Magnetized material is prohibited in international mail except as permitted in IMM 136. A material
with a measurable magnetic field strength greater than 0.00525 gauss at 15 feet is prohibited in the domestic mail.
For domestic mail via air transportation, a magnetized material capable of causing a compass deviation at a
distance of 7 feet or more is prohibited. Mailable materials must be packaged and marked as specified in
Publication 52. Mailable material permitted via air transportation must bear a shipper's declaration for dangerous
goods.
Chapter Nine • FIFRA Pesticide Product Sampling • 9-53
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Chapter Ten
STOP SALE, USE OR REMOVAL ORDERS
Table of Contents
Page
AUTHORITY 10-1
Stop Sale, Use or Removal Orders 10-1
Seizures 10-1
Unlawful Act 10-1
OBJECTIVE 10-1
POLICY 10-1
Special Considerations 10-2
Process 10-2
PROCEDURES 10-3
Service of Order by United States Mail 10-3
Regional Office 10-3
Headquarters 10-3
Service of Order by Inspector 10-3
Refusal to Accept Order 10-3
No One Available to Accept Order 10-4
Disposition 10-4
Violations of Orders 10-4
Follow-up Inspections 10-4
Chapter Ten • SSUROs -10-i
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CHAPTER TEN
STOP SALE, USE OR
REMOVAL ORDERS
AUTHORITY
Stop Sale, Use or Removal Orders
Section 13 (a) of the Federal Insecticide, Fungicide, and Rodenticide
Act ( FIFRA), as amended, authorizes the Administrator to issue a
written or printed Stop Sale, Use or Removal Order (SSURO) to
any person who owns, controls, or has in their custody any
pesticide or device that the Administrator has reason to believe (on
the basis of inspection or tests) is in violation of any provision of
the Act. After a SSURO has been issued against a pesticide or
device, no person shall sell, use, or remove the pesticide or device
except in accordance with the provisions of the order. See section
13 (a) of FIFRA, as amended, for more information on SSUROs.
Seizures
Section 13 (b) of FIFRA, as amended, authorizes the seizure of any
pesticide or device for confiscation and condemnation in any
federal district. See section 13(b)(l) of FIFRA, as amended, for
more information.
Unlawful Act
Section 12 (a) (2) (I) states that it is unlawful for any person to violate
any order issued under section 13.
OBJECTIVE
The objective of a Federal SSURO is to prevent the sale, use, or
removal of any pesticide or device found to be in violation of any
provision of the Act or when the registration of the pesticide or
device has been canceled by a final order or has been suspended.
POLICY
Only EPA Headquarters or Regions may issue Federal SSURO's.
State inspectors, however, may be requested to serve the orders at
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FIFRA Inspection Manual, February 2002
specified locations. SSUROs can be an effective and efficient legal
tool available for protecting humans and the environment. The
policy of EPA is to issue SSUROs whenever EPA has reason to
believe based on inspection or tests that: (1) a pesticide or device is
in violation of any provision of the Act; (2) a pesticide or device
has been or is intended to be distributed in violation of the Act; or
(3) when registration of a pesticide has been canceled by a final
order or has been suspended. The criteria for the issuance of a
SSURO may be found in Chapter 5 of the FIFRA Case Development
Training Manual.
Special Considerations
SSUROs may be issued any time a pesticide is in violation of the
Act. SSUROs, however, are generally reserved for situations
involving a potential hazard to health or the environment. A
SSURO:
* Can be expeditiously issued on the basis of a "reason to
believe" a hazard exists.
*• Extends to all of the pesticide material under the custody or
control of the person.
*• Keeps the responsibility for disposal of the material with the
person receiving the order.
Process
The following summarizes the steps in the SSURO process:
* Identify the violation and develop evidence to support the
existence of a violation.
* Prepare a complete description of the material to be stop
saled, including batch codes.
* Prepare and issue the SSURO.
*• Monitor compliance with the order.
*• Amend the order as necessary to allow movement of the
product for final disposition.
* Vacate the order upon disposal or reconditioning of the
material, or if the SSURO has been vacated.
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PROCEDURES
Service of Order by United States Mail
Regional Office
In certain instances the Regional office may elect to serve the order
via U.S. certified mail.
Headquarters
In instances such as the emergency suspension of a pesticide, EPA
Headquarters may elect to issue the order. Any such orders will be
served via U.S. certified mail.
Service of Order by Inspector
SSUROs may be served by an inspector in certain circumstances,
such as during an inspection.
SSUROs are issued against pesticide products and devices when
EPA has reason to believe they may be in violation of FIFRA.
SSUROs for pesticide products may be specific for a particular
batch or lot but, the norm is to issue the order against all products
bearing the registration that is in violation of the Act.
The inspector will determine the amount of the product that is
under the control of the person to whom the order is served.
The order is served to the owner, operator, or agent in charge of
the establishment which has custody of the violative pesticide
product or device. The inspector must explain to the recipient the
scope and meaning of the order and the obligation which it places
on him/her as recipient. The explanation must include the fact that
the product covered by order cannot be sold, used, or removed
unless vacated by a further order issued by the Regional office. The
inspector must also provide the name of the Regional contact
person (named in the order).
The inspector must also follow any Regional policies regarding the
serving of such orders.
If the inspector is assigned to deliver a SSURO, it may be
appropriate to begin the service of the SSURO like an inspection,
with presentation of credentials and Notice of Inspection. The
"Violation Suspected" section of the Notice of Inspection must
match the violation described in the SSURO. The inspector can
then review and collect records, as necessary, to document violative
activity, and take inventories, if not done previously. If any samples
or documents are collected, the proper inspection procedures must
continue to be followed.
Refusal to Accept Order
In the event that the person to whom the order is served refuses to
accept the order, the inspector shall leave a copy of the order at the
establishment and explain the following to the recipient:
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*• The order becomes effective when delivered and is binding
on the recipient whether or not he/she accepts it.
*• The recipient has the prerogative of discussing the order
with the contact person at the Regional office who is named
in the order.
*• The recipient is liable for a civil or criminal penalty for
violating the terms of the order as well as for the violation
itself.
The inspector must make a detailed record in his/her field
notebook of this conversation and his/her actions for possible use
at any subsequent hearing or court action.
No One Available to Accept Order
If an inspector attempts to deliver an order and the owner or
custodian is not present, a copy of the order may be attached to the
entry door of the establishment, but another copy must be served
by U.S. certified mail. The inspector must keep a record of his/her
actions.
Disposition
The original order must be amended or terminated to permit
movement of the product. A subsequent order may be issued to
permit the custodian of the product to bring the product into
compliance or to properly dispose of it. Such orders can either be
served in person or by U.S. certified mail.
Violations of Orders
If a violation of such order is discovered, the inspector must
proceed as follows:
* Report the violation to the Regional office immediately.
* Document the violation (including the name, title, and duties
of the person responsible for the violation) and send a
written report to the Regional office.
Follow-up Inspections
Follow-up inspections shall be performed to determine compliance
with the SSURO. Standard inspection procedures must be
followed. A written Notice of Inspection must be issued and state
that the purpose of the inspection is to determine compliance with
the SSURO issued on the pesticide (s) listed in the order. The
inspector must confirm that the owner or custodian received the
order and record the date received, if possible. The stock affected
by the order must be counted and documented, including package
sizes and lot numbers. Any discrepancies between quantities in
inventory and amounts stated in the order must be resolved.
If the follow-up is to an order issued by the Regional office, the
above documentation and appropriate statements and records may
be sufficient. Orders issued by EPA Headquarters, however,
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usually require more information. An example would be an order
for a pesticide suspended in accordance with FIFRA section
3(c)(2)(B). In addition to the above information, the inspector
might also take the following actions, as appropriate:
* Confirm that the company satisfied (not just submitted) the
data requirements that were the basis of the Notice of
Inspection to suspend or voluntarily cancel the registration.
If they were officially notified by the Office of Pesticide
Programs (OPP) that the requirements were satisfied, and
the SSURO was lifted, document those facts and terminate
the inspection.
* Determine if the company has requested or received any
additional guidance from EPA concerning disposal. If so,
copy and identify the guidance document(s). Provide the
name of the State organization that will assist the company
with disposal.
* Determine if the company has informed producing
distributors and/or contacted manufacturers. If so, copy and
identify record(s) of these contacts.
* Inspect production records for products named in the order
and compare them to the effective date of the SSURO.
Photograph or photocopy records showing production after
the effective date or last production prior to the effective
date. Production is not prohibited. The reason for looking at
production records is to determine that, as a minimum, the
volume of production after the notification remains in
physically accountable stock. Production records also help
determine the dates of sales invoices and shipping records to
review. (Note: Some information obtained during these
inspections may be claimed as FIFRA confidential business
information (CBI). If the establishment is inspected by a State
inspector using State credentials and State statutory
authority, any CBI information/documents in question
should be: (1) only provided to the State inspector on a
consensual or voluntary basis after the State informs the
establishment they are cleared (by State statute) to view,
obtain, or copy FIFRA CBI or (2) if claimed CBI, request the
responsible company official to send the
information/documents directly to the EPA Regional FIFRA
Document Control Officer (DCO). The inspector should
provide the responsible company official with a listing of all
requested documents/information to be sent to the EPA
Regional office). The inspector should notify the DCO that
documents are being submitted to the Region from the
company and specify who in the Region is expecting them.
The inspector should not rely upon the company to send a
cover letter explaining the reasons the documents were sent.
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FIFRA Inspection Manual, February 2002
If available, check inventory records for the date of the
inspection and the effective date of the order. If those
records are not the same, copy them and determine why
they differ and/or inspect sales invoices and bills of lading
for the named pesticide from the date of inspection back
through the effective date of the order. Copy or photograph
those invoices/bills which appear to indicate a violation.
Chapter Ten • SSUROs • 10-6
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Chapter Eleven
RECALLS
Table of Contents
rage
AUTHORITY 11-1
Statutory/Regulatory Requirements 11-1
Voluntary Recall [Section 19 (b) (2)] 11-1
Mandatory Recall [Section 19(b)(3)] 11-1
Recall Procedure 11-1
Contents of Recall Plan [Section 19(b)(5)] 11-2
Special Considerations 11-2
OBJECTIVES 11-2
PROCEDURES 11-3
Process 11-3
Recalls 11-3
Levels of Recalls 11-3
Notification to the Company 11-4
Inspection Procedures 11-4
Initial Visit to Company 11-4
Follow-Up to Recall 11-4
Follow-up After Completion of Recall 11-5
Reporting 11-5
Initial Recall Report 11-5
Interim Reports 11-5
Final Recall Reports 11-5
Follow-Up Reports at Consignees 11-6
Chapter Eleven • Recalls • 11-i
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CHAPTER ELEVEN
RECALLS
AUTHORITY
No regulation currently exists under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) for the mandatory recall
of products. The effectiveness of a recall action, therefore, is
contingent on the cooperation of the involved party. Section 19 (b)
of FIFRA contains authority for mandatory and voluntary recall of
products if the registration of a pesticide has been suspended and
canceled under section 6. The Regulations to implement section 19
have been proposed, however they have not been codified.
Statutory/Regulatory Requirements
If the registration of a pesticide has been suspended and canceled
under section 6 of FIFRA, and if the Administrator finds that recall
of the pesticide is necessary to protect health or the environment,
the Administrator shall order a recall of the pesticide.
Voluntary Recall [Section 19(b)(2)l
If, after determining that a recall is necessary, the Administrator
finds that voluntary recall by the registrant and others in the chain
of distribution may be as safe and effective as a mandatory recall,
the Administrator shall request the registrant of the pesticide to
submit, within 60 days of the request, a plan for the voluntary recall
of the pesticide. If such a plan is requested and submitted, the
Administrator shall approve the plan and order the registrant to
conduct the recall in accordance with the plan unless the
Administrator determines, after an informal hearing, that the plan is
inadequate to protect health or the environment.
Mandatory Recall [Section 19(b)(3)l
If, after determining that a recall is necessary, the Administrator
does not request the submission of a plan under section 19(b)(2), or
finds such a plan to be inadequate, the Administrator shall issue a
regulation that prescribes a plan for the recall of the pesticide. A
regulation issued under this paragraph may apply to any person
who is or was a registrant, distributor, or seller of the pesticide, or
any successor in interest to such a person.
Recall Procedure [Section 19(b)(2)]
A regulation issued under this section 19(b)(2) of FIFRA may
require any person that is subject to the regulation to:
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FIFRA Inspection Manual, February 2002
*• Arrange to make available one or more storage facilities to
receive and store the pesticide to which the recall program
applies, and inform the Administrator of the location of each
such facility.
* Accept and store at such a facility those existing stocks of
such pesticide that are tendered by any other person who
obtained the pesticide directly or indirectly from the person
that is subject to such regulation.
* On the request of a person making such an offer, provide for
proper transportation of the pesticide to a storage facility.
* Take such reasonable steps as the regulation may prescribe
to inform persons who may be holders of the pesticide of the
terms of the recall regulation and how those persons may
tender the pesticide and arrange for transportation of the
pesticide to a storage facility.
Contents of Recall Plan [Section 19(b)(5)l
A recall plan established under this subsection shall include:
*• The level in the distribution chain to which the recall is to
extend, and a schedule for recall.
*• The means to be used to verify the effectiveness of the recall.
Special Considerations
The voluntary/mandatory statutory recall provision was added to
FIFRA in 1988 and relates only to pesticides suspended or
cancelled under section 6. Voluntary or mandatory recalls provide
the most expeditious means of removing pesticides from channels
of trade and may continue to be used for these purposes. Failure to
comply with a voluntary/mandatory recall will result in the issuance
of a stop sale, use, or removal order to the consignees of the
pesticide in question.
OBJECTIVES
The voluntary recall program is designed to remove any violative
product (such as an ineffective antimicrobial pesticide) from the
market as expeditiously as possible. Recalls will be initiated in all
cases in which the available information indicates that the product
is (1) potentially hazardous when used as directed, or (2) ineffective
for the purpose(s) claimed. A product will be considered for recall
when, among other things, its use as directed would likely result in
the following:
*• Economic or physical injury to the user or handler of the
product.
*• Injury to animals or plants where direct application is made.
*• Injury resulting from illegal residues.
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FIFRA Inspection Manual, February 2002
*• Injury to fish or wildlife.
* Other adverse effects on the environment.
A recall may be made after the cancellation by EPA of a product
due to lack of existing tolerance, environmental damage caused by a
pesticide's labeled uses, or EPA actions taken under the Food
Quality Protection Act (FQPA) of 1996 during a pesticide's
registration or re-registration, such as cancellation due to harm to
workers, or human health risk analysis.
PROCEDURES
Process
The following summarizes the steps in the recall process:
* Identify the violation and develop evidence to support the
violation and the hazard presented.
* Prepare a complete description of the material to be recalled
and the level in the distribution chain to which the recipient
will be requested to remove the product.
* Prepare and issue the recall.
*• Monitor the quantities from each location returned.
*• Monitor the disposition of all returned material.
Recalls
A recall is conducted to prevent serious problems in the future. It is
essential that the recall action be followed up by a visit to the
company involved and that cooperating State officials be notified.
The remainder of this section details the monitoring procedures to
be followed by the inspectors in this type of recall.
Levels of Recalls
The level of recall refers to the point in the distribution chain from
which the product is to be recalled. The determination of that point
is based on the potential hazard, use pattern, and distribution
pattern of the product. The levels of recall can extend to the
following:
* Pesticide products under the registrant's control.
*• Products in the chain of distribution not under the control of
the registrant.
* User-level recalls will be requested only in cases in which
there is a very serious hazard to human health or the
environment.
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FIFRA Inspection Manual, February 2002
Notification to the Company
EPA will send the company headquarters a notification requesting
a recall. The letter must include:
*• A brief summary of why EPA is requesting a recall.
*• A request that the company provide EPA with the amount
and location of product that is being recalled (if it is known).
*• A request that the company inform EPA of all steps taken in
connection with the recall and provide an accounting of the
amount that was actually recalled.
Additionally, EPA may provide draft recall letters for the company
to send to their primary and secondary distributors and for those
distributors to send to their customers. A draft "Recall
Effectiveness Checklist" may also be included for customers to fill
out and return to their dealers.
The company is encouraged to contact EPA and discuss the notice.
In urgent cases, EPA will initially notify the company by telephone
and/or facsimile.
Inspection Procedures
After the company has received notification of recall from EPA, an
inspector will be assigned to monitor the recall. The inspector may
receive the recall notification. In some instances, the inspector may
receive a strategy for monitoring the recall. The inspector will
always receive a copy of the recall agreement between the
registrant(s) and the EPA. In those instances where a strategy has
not been provided, the Regional Supervisor and the inspector must
develop their own strategy before proceeding. Each recall is unique.
The inspector must review and understand the terms of the recall.
An initial visit to the firm must be planned to occur about 30 days
after the date of the recall letter. The 30-day time period provides
adequate time for the company to respond to the notice and decide
upon a course of action.
Initial Visit to Company
The inspector must review the progress of the recall with the
responsible company official and obtain copies of documents,
records, and correspondence used by the company in the recall. If
the inspector discovers that the terms of the recall are not being
met (e.g., failure to notify distributors as required), the inspector
must document the noncompliance. This may be accomplished by
photocopying appropriate documents or taking statements from
knowledgeable persons.
Follow-Up to Recall
The inspector may conduct interim visits to the company or receive
status reports from the company to document how the recall is
proceeding.
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Follow-up After Completion of Recall
Upon receiving information from the company that all available
product has been located and either returned or other appropriate
action taken, the Regional EPA Pesticide Supervisor may institute
procedures to visit a selected number of consignees to determine
the effectiveness of the recall. Each consignee visited must be
asked whether the firm received a recall letter, whether any of the
product in question was on hand and, if so, if the company
complied with the recall letter. Document as appropriate.
Reporting
All inspection reports must be provided to the Regional Supervisor
for evaluation and a summary of the inspection reports must be
forwarded to EPA Headquarters.
Initial Recall Report
The initial visit report must be a narrative which reflects the
company's efforts to implement the recall and will include:
*• When appropriate, a list of consignees to whom the recall
letters were mailed and the date(s) sent.
*• Any documentation obtained during the visit.
Interim Reports
Interim reports must be submitted on: (1) a regular basis as
required by the compliance strategy, and (2) whenever any new
information becomes available.
Final Recall Reports
The Final Recall Report is the inspector's narrative summarizing
actions taken by the company and must be submitted as soon as
the recall is completed. This report must include the following
information:
*• Name of the product being recalled.
*• EPA Reg. No. of the product being recalled.
* Batch number(s) of the product being recalled.
*• Name, address, and contact for the company that received
EPA's letter requesting the recall of the product.
* Action taken by the company, such as:
• Number of consignees the company had and number of
consignees they contacted.
• Actual amount of the product the company distributed to
consignees.
• Amount of products the consignees still have in their
control.
• Number of consignees that returned product.
• Total amount of product returned for all of the consignees.
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FIFRA Inspection Manual, February 2002
• What the company did with the product (Did they dispose
of it or reuse it?).
*• Which consignees the inspector visited; dates of inspections;
and documented discrepancies.
Follow-Up Reports at Consignees
These reports of effectiveness must be included as attachments to
the final recall report.
Chapter Eleven • Recalls • 11-6
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Chapter Twelve
USE INSPECTIONS AND FOLLOW-UP ENFORCEMENT
Table of Contents
Page
AUTHORITY 12-1
Introduction 12-1
Statutory Basis 12-1
Consent 12-2
Open Fields 12-2
Exigent Circumstances 12-3
Plain View 12-3
OBJECTIVES 12-3
POLICY 12-4
USE INSPECTIONS 12-4
Inspector Obligations and Procedures 12-5
Use Inspection Procedures 12-5
Persons Interviewed 12-5
Description of Facility 12-6
Pesticide(s) Inspected 12-6
Records Review 12-7
Storage Facility Conditions 12-7
Worker Protection Standard (Ag Use ONLY) 12-7
Sampling 12-7
Documentary Samples 12-7
Physical Samples 12-7
Specific Sampling Procedures 12-8
Records 12-8
Discussion with Owner/Operator, Applicator, or Agent in
Charge 12-9
FOLLOW-UP INVESTIGATION PROCEDURES 12-9
Inspector Obligations and Procedures 12-10
Conducting the Investigation 12-10
Sampling 12-11
Records 12-11
Reports 12-11
Exhibit 12-1: Notice of Use/Misuse Inspection (EPA Form 3540-25) 12-13
Exhibit 12-2: Use Investigation Report (EPA Form 3540-20) 12-14
Exhibit 12-3: Receipt for Use/Misuse Samples(EPA Form 3540-26) 12-15
Exhibit 12-4: Biosecurity Guidance 12-16
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-i
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CHAPTER TWE LVE
USE INSPECTIONS &
FOLLOW-UP
ENFORCEMENT
AUTHORITY
FIFRA authorizes primary enforcement responsibility to states for
pesticide use violations; see section 26 of FIFRA for more
information.
Introduction
Use inspections and follow-up investigations are a necessary and
indispensable element of pesticide use enforcement. While section
12(a)(2)(G) of FIFRA, as amended, makes it unlawful to use any
registered pesticide in a manner inconsistent with its labeling, it
does not give the federal inspector right of entry to conduct the
inspection/investigation.
The Fourth Amendment of the U.S. Constitution states, in part:
"the rights of the people to be secure in their persons, houses,
papers, and effects, against unreasonable searches and seizures,
shall not be violated..." To ensure lawful inspections, the Agency
has developed procedures consistent with this provision and
relevant court decisions.
Statutory Basis
FIFRA section 12(a)(2)(G) and section 2(ee) state that "it shall be
unlawful for any person to use any registered pesticide in a manner
inconsistent with its labeling."
The phrase "to use any registered pesticide in a manner
inconsistent with its labeling" means to use any registered pesticide
in a manner not permitted by the labeling. This does not include:
* Applying a pesticide at a rate, concentration, or frequency
less than specified on the labeling, unless the labeling
specifically prohibits deviation from the specified rate,
concentration, or frequency.
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+ Applying a pesticide against any target pest not specified on
the labeling if the application is to the crop, animal or site
specified on the labeling, unless the Administrator has
required that the labeling specifically state that the pesticide
may be used only for the pests specified on the labeling after
the Administrator has determined that the use of the
pesticide against other pests would cause an unreasonable
adverse effect on the environment.
*• Employing any method of application not prohibited by the
labeling.
*• Mixing a pesticide or pesticides with a fertilizer when such
mixture is not prohibited by the labeling.
*• Any use of a pesticide in conformance with section 5,18, or
24 of this Act.
*• Any use of a pesticide in a manner that the Administrator
determines to be consistent with the purposes of the Act.
An advisory opinion was issued on March 3, 1981. It permits the
use of less diluent than that specified on the label in ultra low
volume (ULV) and low volume agricultural and forestry
applications. This advisory opinion does not permit a discretionary
choice of diluent different than that specified on the label,
regardless of the recommendation by an authorized person or
entity (see Federal Register Vol. 46. Number 41, March 3, 1981).
Consent
Entry to conduct use inspections/investigations is authorized
pursuant to obtaining valid consent. To be considered valid,
consent must be given freely and voluntarily and not as a result of
duress, misrepresentation, or coercion (either expressed or
implied). While the law does not require that a subject be advised
of his/her right to refuse to give consent, if the inspector believes
such knowledge may be helpful in validating the consent and in
overcoming any taint of implied coercion, he may inform the
consenting party of his/her right to refuse voluntary entry. In
addition, the person granting the consent must be authorized to do
so. The inspector must be certain that the consenting party has the
premises under his/her control and has at least the apparent
authority to give consent.
In the case of inspections that involve multiple instances of entry
or sampling episodes, it is imperative that consent be gained for
each entry or sampling unless prior consent has been obtained to
cover all necessary entry and sampling. Accordingly, at the onset of
an inspection, the inspector must seek to gain consent sufficient to
authorize all entry and sampling activities he/she contemplates will
be necessary to complete the inspection.
Open Fields
"Open fields" are areas where a land owner normally does not have
a reasonable expectation of privacy. While the preferred procedure
is to obtain valid consent prior to entry, the courts have established
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that inspectors may enter open, private lands in the official
performance of their duties. The inspectors may technically be
trespassers on private property, but this fact will not prevent the
lawful use of any evidence that is obtained in these open fields.
This inspection authority does not extend to a residence or the area
immediately surrounding a residence.
Exigent Circumstances
The law does not require a public official to stand by helplessly
while a serious offense endangering human health or the public
safety is occurring on private property. If there is insufficient time
to procure a warrant before serious harm will occur and if consent
to enter cannot be readily obtained, an inspector may enter the
property to assist in preventing imminent harm to human life.
Because of the heavy burden imposed on the Agency to show that
its entry without authority was justified, this doctrine shall be used
only in rare and emergency circumstances.
Plain View
The plain view doctrine is an acknowledgment by the courts that an
inspector lawfully engaged in the course of his/her duties is not
required to wear blinders or close his/her eyes to whatever is
occurring around him/her. This principle applies regardless of the
nature of the inspection (use, producer, marketplace, etc.). The
following elements are required for a plain view observation:
* Lawfully Present. The inspector must be justified in being
where he/she is at the time the plain view observation is
made. Lawful presence may be gained through such
avenues as statutory authority, a valid search warrant,
consent, or "open fields."
*• Inadvertent Discovery. The inspector must discover the
evidentiary items accidentally. The plain view doctrine will
not apply if the inspector has probable cause to believe that
an item is on certain premises and goes on those premises
with the intention of searching for that item; such a
discovery is not inadvertent.
* Apparently Incriminating Nature. The inspector must have
reasonable grounds to believe immediately, without further
investigation, that the item in plain view constitutes
evidence of a violation of the law.
OBJECTIVES
The objectives of use inspections and follow-up investigations are
to:
* Protect health and the environment.
* Determine compliance with FIFRA.
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-3
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FIFRA Inspection Manual, July 2002
Collect information for use by the Agency to determine the
need for pesticide label and labeling changes.
POLICY
Primarily in states without primacy, and federal and tribal lands, the
Agency will conduct (1) a routine inspection program and (2)
follow-up of reported cases of misuse and suspected pesticide-
related incidents with investigations. Additionally, EPA will
conduct inspections where states have waived their section 26(b)
authority or where states have not acted in a timely manner (section
27), or at the request of states/tribes.
USE INSPECTIONS
Use inspections encompass a wide variety of pesticide use
circumstances and inspection sites. Although many aspects of
pesticide compliance are involved, the primary focus is on use
inconsistent with the label and the Worker Protection Standard.
Inspection opportunities include, but are not limited to the
following areas of pesticide use:
* Agricultural (commercial and private)
• Field crops
• Planting times (and plant back restrictions)
• Orchards/groves
• Greenhouses/nurseries
• Sod farms
• Forests
• Vegetable and specialty crops
* Nonagricultural (commercial, public, and not-for-hire)
• Residential sites
• Structures
• Rights-of-way
• Aquatic environments
• Hospitals/nursing homes/clinics
• Veterinarians
• Lawns, ornamentals, and golf courses
• Grain elevators
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-4
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FIFRA Inspection Manual, July 2002
Use inspections can be initiated at either the site of application or
the applicator's place of business.
Use includes storage, handling, mixing/loading, transportation,
application, and disposal.
Use inspections may be performed during application or during any
"use" activity (see above). Use inspections may also occur where
pesticides have previously been applied, including inspection at the
end of a growing season when the crops are being harvested.
Note: At all times during Use/Misuse Inspections, the
inspector should be aware of bio-security. See Exhibit 12-4
for guidelines to be followed when entering and exiting farms,
ranches, etc.
Inspector Obligations and Procedures
The inspector must seek the most responsible individual available
at the inspection site and present his/her credentials to that person.
Before beginning any use inspection, the owner, operator, or agent
in charge must be issued a written Notice of Use/Misuse
Inspection (EPA Form 3540-25) (Exhibit 12-1). The notice must
include the reason for the inspection and any suspected violations.
The Notice of Use/Misuse Inspection form contains a "consent"
statement that the inspector shall read to the person from whom
consent is sought. The form also bears a space for the person to
sign so as to provide a written record of the authorization to enter
and/or sample based on consent.
If entry is refused, the inspector must immediately notify his/her
supervisor.
Use Inspection Procedures
The collection of records of use and application are an essential
part of every use/misuse inspection and investigation. These
records document use and, in addition, can be used to either
contradict or corroborate statements regarding how pesticides were
used and the circumstances surrounding their use. These records
should be identified as exhibits and attached either to the report or
to the appropriate statement.
The inspector must obtain the relevant information necessary to
complete a narrative report of the inspection. This information
includes, but is not limited to the following:
Persons Interviewed:
* Name, address, and telephone number of facility.
*• Name, address, and telephone number of inspection site, if
different from above.
*• Owner, operator, and/or agent-in-charge of facility.
*• Owner of inspection site, if different from above.
*• Certification, license, or permit number of applicator.
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-5
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FIFRA Inspection Manual, July 2002
Description of Facility:
Physical description and location of the inspection site, i.e. hospital,
aerial applicator, golf course, etc. including address, telephone
number, and contact person.
Pesticide(s) Inspected:
*• Name, EPA Registration Number, EPA Establishment
Number, and classification of pesticide(s) used (i.e., general
or restricted use).
* Note types of pesticides in storage, i.e. restricted, canceled,
suspended, etc.
* Collect a physical of the product if a problem is suspected
with product chemistry or a documentary sample of the
product label if a misuse is suspected.
*• The inspection report, as appropriate, shall also include a
thorough review of the label(s) encountered and contain
written documentation that the pesticide(s) was/were used
as specified by the label. Specific areas of pesticide use to be
addressed should include:
• Crop, area, or object treated
• Method and rate of application
• Disposal (rinsate/containers)
• Mixing/loading instructions
• Diluent/additives
• Worker Protection Standard
• Protective clothing and equipment
• Precautionary statements
• Environmental precautions
• Transportation/storage
• Pre-harvest intervals
• Spray intervals
• Classification
• Relevant weather restrictions
• Ground-water protection restrictions
• Endangered species protection restrictions
Note: Specific pesticide labels vary greatly. The above list is not
meant to be inclusive. Individual labels should be examined in
each inspection and relevant or suspected areas should be
investigated in accordance with established procedures.
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-6
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FIFRA Inspection Manual, July 2002
Records Review:
Review records required under federal and/or State regulations.
Storage Facility Conditions:
Inspect storage area for leaking containers, security of restricted use
pesticides, etc.
Worker Protection Standard (Ag Use ONLY):
A thorough label review should take place so that compliance with
label requirements can be determined and to determine the
applicability of the other provisions of the Worker Protection
Standard. Address the following items during the inspection if the
Worker Protection Standard applies:
*• Information at the central location
* Application records
* Pesticide safety training
* Decontamination supplies
* Notice of application and posting of application
*• Early entry requirements
*• Emergency assistance procedures
The Use Investigation Report (EPA Form 3540-20) or equivalent,
may be used to assist the inspector in documenting use information
(Exhibit 12-2).
Sampling
The collection of official samples for evidence is an important part
of this program. Samples may also be collected to substantiate that
pesticides were properly mixed and applied. It is essential to collect
documentary samples or physical samples of any/all pesticides
suspected of having been misused.
Documentary Samples
A documentary sample must be collected when a physical sample is
not necessary, including those circumstances where no problem
with the chemistry of the pesticide is suspected. Documentary
samples consist of anything other than a physical sample (e.g. bin
labels, photographs, advertising or records such as, invoices,
shipping records, bills of lading, etc.)
Physical Samples
*• Formulation Samples. If the user is obtaining unusual or
adverse results from the use of a product and his/her use is
in accordance with label directions, a sample of the
commercially packaged pesticide must be taken to determine
whether it was misformulated. A formulation sample must
also be collected for each use dilution sample to verify that
problems associated with the use dilution are not related to
the pesticide itself. A reasonable effort must be made to
collect a sample at the user, dealer/distributor level. If it is
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-7
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FIFRA Inspection Manual, July 2002
necessary to obtain a sample from a previously opened
container, the investigator must obtain a statement from the
user stating that the product has not been altered (see
Chapter 9 for Formulation Sampling).
*• Diluted Material. Pesticides diluted or mixed for use must
be sampled at the user level whenever there is reason to
believe that the pesticides may have been diluted or mixed
in a manner inconsistent with the label. Conversely, these
samples may be taken to show that the dilution was
consistent with label directions. This type of sample may be
difficult to collect and preserve. Thus, they must be
collected when mixing differs from label directions or
improper pesticide selection is suspected. A copy of the
registered product's pesticide label must be obtained to
accompany the sample of diluted material. If a photograph
of the label and/or a identical label copy cannot be obtained
to accompany the sample, the pertinent portions of the label
(ingredient statement and applicable dilution/mixing
directions) must be hand-written and attached to the sample.
If not observed first hand, a statement and/or record copy
must be obtained from the user telling how the material had
been diluted and mixed. Because the dilution rate may vary
with the specifications of the application equipment used,
information must be obtained regarding the type of
application equipment used and its calibration. If the
pesticide is being applied in accordance with section 2(ee)
recommendations, the source of those recommendations
must be documented with a copy of the recommendations
and/or a statement from the applicator.
* Residue Samples. Residue samples include plant materials,
animal tissues, soil, drinking water, surfaces, air, runoff
water, etc. A residue sample must be collected when there is
reason to believe that a pesticide may have been misapplied.
Specific Sampling Procedures
Refer to Appendix A.
Records
Determine what records are being maintained by the
applicator/firm, review pertinent records, and document the
pesticide application in question, even if no violations are apparent.
Pesticide application records for adjoining properties and field
history(s) must be documented to address pesticide drift and carry-
over issues. Additionally, document application records of all
apparent or suspected violations. Note: Applicators/firms are
only required to keep records for RUP use. However, State
requirements may specify that all pesticide applicator records be
maintained by the applicator/firm.
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-8
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FIFRA Inspection Manual, July 2002
Discussion with Owner/Operator, Applicator, or
Agent in Charge
The inspector must discuss proper pesticide use with the
owner/operator, applicator, or agent in charge. Topics that should
be covered include (1) the existence and purpose of FIFRA, (2) the
importance of following label directions, and (3) the need to use
pesticides safely, so as to protect human health and the
environment by observing all label precautions during all phases of
use, including mixing, application, storage, and disposal.
The inspector must give the owner, operator, applicator, or agent in
charge of the establishment a copy of the completed and signed
Receipt for Use/Misuse Samples (EPA Form 3540-26) (Exhibit 12-
3) for any official samples.
The results of the inspections must be discussed with management.
Any problems or discrepancies noted during the inspection must be
brought to the attention of the applicator/management so that
immediate corrective action may be taken. The inspector must
explain that violations maybe found by the laboratory and/or
Regional office.
The inspector must note in the Inspection Report any voluntary
corrective actions.
FOLLOW-UP INVESTIGATION PROCEDURES
An investigation will be conducted in response to reported or
suspected incidents to develop the necessary evidence to support
any enforcement action that may be taken as a result of an apparent
pesticide misuse. Because the ultimate purpose of a follow-up
investigation is to substantiate and document alleged pesticide
misuse, the inspector's function shifts from a more passive role, as
in the context of a use inspection, to a more investigative role.
Follow-up investigations tend to be more complex than use
inspections, because the inspector may be required to visit a
number of sites, interview various persons, and/or collect a
number of samples of various types in the course of a single
investigation. See Appendix C for information on handling high
visibility incidents.
The inspector investigating a case of alleged misuse is trying to
find and document answers to a number of questions, while the
routine pesticide use inspection typically only involves the
observation and documentation of the physical elements involved
at the time of the application. Parties involved in an investigation
may include, but are not limited to the following:
• Complainants • Physicians/Veterinarians
• Applicators • Pest Control Operators,
Dealers/Distributors
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-9
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FIFRA Inspection Manual, July 2002
• Eye Witnesses • Other Federal, State,
and/or local Agencies
• Cooperative • Other Experts and/or
Extension operators
• Property Owners • Agricultural
Employers /Employees
Inspector Obligations and Procedures
Due to the potential for harm to humans and the environment and
the need to be responsive to public concern, it is important that the
inspector initiate follow-up investigations as soon as possible after
the receipt of an alleged misuse. Also, the chances of finding
pesticide residues in environmental samples decreases over time.
Credentials must be presented and the appropriate written
inspection notice issued at each facility or location where persons
are interviewed or samples are collected. A Notice of Inspection
must be used where pesticides are held for distribution or sale. A
Notice of Use/Misuse Inspection must be used at other locations
(refer to Chapter 7).
*• Interview complainant, witness, and other parties involved.
* Complete statements, etc.
* Complete a narrative report of the investigation to include
details of the inspection.
* Collect and document all evidence pertaining to the use of
the pesticide to include photographs, all labeling,
diagrams/maps, shipping/purchasing records, etc.
* Collect documentary and/or physical samples of pesticide
use.
Conducting the Investigation
The inspector must interview, at a minimum, the complainant and
the applicator. When interviewing the applicator, the procedures
outlined in this section must be followed. Additional interviews
should be conducted as necessary.
When conducting a follow-up investigation, it will be necessary to
gather sufficient documentary and physical evidence to support any
alleged violations of FIFRA. This evidence may include the
following:
* Photographs, originals, or copies of labels and labeling for
pesticides used.
* Photographs or video tapes showing actual pesticide misuse
and/or damage caused by an alleged misuse.
* Application records and central location information (refer
to the WPS Pocket Guide).
* Copies of the applicator certification documents.
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-10
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FIFRA Inspection Manual, July 2002
* Statements from the property owner, applicator,
owner/operator, or witnesses that can attest to the relevant
circumstances.
* Copies of any available investigation reports completed by
other agencies or companies including State and local
agencies, insurance companies, etc.
* Sketches or maps of the area treated and surrounding
properties.
* Samples (Physical or Documentary).
Sampling
Refer to Chapter 13 (Residue and Environmental Samples) and
Appendix A.
Records
The inspector must determine what records are routinely
maintained by the applicator/responsible firm. Pertinent records
must be reviewed and all apparent violations as well as records
specific to the application must be documented. In some cases,
records of applications that were made immediately prior to the
incident application must be collected in case cross contamination
of the pesticide solution is a possibility.
It may be necessary to collect copies of other records, including but
not limited to, the following:
* Written recommendations (advisor, consultants,
USD A/Cooperative Extension Service bulletins, etc.).
* State and/or locally required permits and/or notifications.
* Weather records.
* Certification/licensing records.
* Additional labeling (Supplemental Labels).
* Regulations/standards.
*• Work order or mix/load sheets.
* Medical Records.
* Application records from application(s) to adjoining
property (ies).
*• Employee records (WPS).
* Witness statements (i.e., WPS training).
Reports
A narrative report must be submitted as soon as possible following
the completion of the investigation. At a minimum, the report
must indicate whether a pesticide was involved. If a pesticide was
involved, the report must indicate what pesticide was used; where it
was applied (site/crop); how it was applied (method, dilution rate,
application rate, application equipment, safety equipment, etc.);
weather conditions (if appropriate); who the responsible party is;
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-11
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FIFRA Inspection Manual, July 2002
and when the pesticide was applied. In addition, the report must
include all other relevant information such as consequences of the
application (drift, crop damage, illness, or injury); explanation of
samples, photographs and other evidence collected; and a
description of any follow-up investigations that may be warranted.
All completed forms and documents gathered during the course of
the investigation must be attached to the narrative report as
exhibits. The report must be limited to factual information. The
introduction of personal opinions into the written narrative allows
an opportunity for the defendant to find fault and could result in
the dismissal of a case. Keep the reports factual.
Other useful tools to assist inspectors in conducting use/misuse
inspections include:
*• EPAWorker Protection Field Inspection Pocket Guide
(EPA 300-B-02-001, March 2002).
*• EPA Worker Protection Standard Phrase Translation Cards
and Tape (1999).
* EPA Worker Protection Inspection Guidance (EPA 722-B-94-
002, January 1994).
For more information see Chapter 20 - Preparing Inspection
Reports.
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-12
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FIFRA Inspection Manual, July 2002
Exhibit 12-1: Notice of Use/Misuse Inspection (EPA Form 3540-25)
UNITED STATES
VX _ '*% ENVIRONMENTAL PROTECTION AGENCY
| G T*
1 S2K J NOTICE OF PESTICIDE
%P«^ USE/MISUSE INSPECTION
NAME OF INDIVIDUAL TITLE
SJAME (Firm, . F&rm&r, Homeowner, etcj ADDRESS {Num
ADDRESS (EPA Regional Officer)
DATE HOUR
A.M.
P. M.
bar, Strttat, City, St&tts, find ZIP Coote/
REASON FOR INSPECTION
FOB THE PURPOSE OF INSPECTING SITES WHERE PESTICIDES ARE BEING USED TO COLLECT DATA ON THE USE OF
PESTICIDES AND TO DETERMINE WHETHER PESTICIDES ARE BEING USED IN COMPLIANCE WITH THE FEDERAL INSECTI-
CIDE. FUNGICIDE, AND RODENTICIDE ACT; AND FOR THE PURPOSE OF INSPECTING SITES WHERE PESTICIDES HAVE BEEN
USED TO DETERMINE WHETHER THE PESTCIDES WERE USED IN COMPLIANCE WITH THE FEDERAL INSECTICIDE, FUNGI-
CIDE. AND RODENTICIDE ACT.
VIOLATION SUSPECTED:
CONSENT
Voluntary Consent Necessary to Enter for Inspection and/or Sampling
The i]nde.tsiened hereby voluntarily consents Us isn inspection ot .of which I am
Owner, Ageni or Pcrson-ln-Charge, for (he purposes of gathering inforn ation and/or samples in connection with the administration and enforcement
of I-'II-'RA 1 understand that 1 have [he riglu to refuse consent to this entry
SIGNATURE TITLE
DATE
EPA FORM 3S4Q-25 (Rev. O1-O1)
1. OriQinal - USE REPORT COPY
2. OWNER/AGENT COPY
3. REGION COPY
4. INSPECTOR'S COPY
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-13
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FIFRA Inspection Manual, July 2002
Exhibit 12-2: Use Investigation Report (EPA Form 3540-20)
xvEPA
i.
a NAME
c. TELEPHONE
2.
a. NAME
c. TELEPHONE d.
3.
a. NAME
c. TELEPHONE
d. TYPE OF BUSINESS a. CRO
f. TARGET PEST
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
USE INVESTIGATION REPORT
PERSON INTERVIEWED
ta. ADDRESS
APPLICATOR
b. ADDRESS
CERTIFICATION NUMBER
SITE OF APPLICATION
b. ADDRESS
P, AREA OR OBJECT TREATED
g. DATE AND TIME OF APPLICATION
h. WEATHER AT TIME OF APPLICATION (Wind, temperature, humidity, fain, ate., list source of information]
4.
a. BRAND NAME
e. TYPE OF FORMULATION
Qj DUST Q SPRAY
6.
PESTICIDE APPLIED
b. EPA REG. NO. c. B
ATCH NO. d. CLASSIFICATION
PGRANULAR QMIST QFOG Q OTHER (Spscify):
RATE OF APPLICATION
a. METHOD OF APPLICATION
b. DILUTION RATE
c. DILUTED MATERIAL APPLIED PER UNIT (Gallons/Acre} e. ACTUAL ACTIVE PER UNIT (Lbs/Acra)
6.
a. FORMULATION
SAMPLES COLLECTED (List sample numbers)
b. DILUTED MATERIAL a. RESID
UE
7. WERE THE FOLLOWING LABELING INSTRUCTIONS FOLLOWED? DYES UNO (If "NO, " check and explain)
n TARGET PEST [J RATE OF APPLICATION fl REENTRY INTERVAL
U METHOD OF APPLICATION n CROP, AREA OR OBJECT TREATED IJ APPLICATOR CERTIFIED
n DILUTION USED U CAUTIONARY LABELING n PREHARVEST INTERVAL
U OTHER:
8. CONSEQUENCES OF USE (List
9. REMARKS
1O. DATE OF INVESTIGATION 11
any unusual results or adv&rse effects from treatments)
. TIME 12. INVESTIGATOR (Signature) 1
3. TITLE
EPA FORM 3B4O-2O (Rev. O1-O1)
1. Original - REGION COPY
2. INTERVIEWEE COPY
3. HEADQUARTERS COPY
A. INSPECTOR'S COPY
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-14
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FIFRA Inspection Manual, July 2002
Exhibit 12-3: Receipt for Use/Misuse Samples (EPA Form 3540-26)
xvEPA
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
RECEIPT FOR PESTICIDE
USE/MISUSE SAMPLES
ADDRESS (EPA Regional Office)
DATE
NAME OF INDIVIDUAL
NAME (Firm. Farmer. Homeowner, etc.)
ADDRESS (Number, Street. City. State, and ZIP Code)
SAMPLE NUMBERS
SAMPLES COLLECTED (Describe fully: List Registration, Lot, Batch, Model. Serial Numbers, and other postive identification)
The following pesticide and/or environmental samples were collected by the U.S. Environmental Protection Agency in
connection with the administration and enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act and
receipt is hereby acknowledged.
SIGNATURE (Owner, Operator, or Agent)
TITLE (Owner, Operator, or Agent)
I DUPLICATE SAMPLES
I REQUESTED
AND PROVIDED
DUPLICATE
SAMPLES NOT
REQUESTED
SAMPLES WERE
QPURCHASED
RECEIVED, NO CHARGE
AMOUNT PAID FOR SAMPLES
Q VOUCHER
D TO BE BILLED
NAME OF COLLECTOR (Print or Type)
TITLE OF COLLECTOR SIGNATURE OF COLLECTOR
EPA FORM 3540.26 (Rev. O1-O1)
1. Original - OWNER/AGENT COPY
2. SAMPLE RECORD COPY
3. REGION COPY
4. INSPECTOR'S COPY
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-15
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FIFRA Inspection Manual, July 2002
Exhibit 12-4: Biosecurity Guidance
December 10, 2001
MEMORANDUM
SUBJECT: Routine Biosecurity Procedures for EPA Personnel Visiting Farms, Ranches,
Slaughterhouses and other Facilities with Livestock and Poultry
FROM: Michael M. Stahl, Director /s/
Office of Compliance
TO: Acting and Current Regional Administrators and Deputy Regional Administrators
Attached is the final biosecurity guidance for EPA personnel visiting livestock or poultry
facilities, including ranches, dairies, feed yards, sale yards, swine premises, slaughterhouses, and
other facilities where there are animals or unprocessed animal tissues that may transmit diseases.
The guidance was prompted by heightened national concern about the spread of animal diseases.
Failing to take appropriate steps to prevent disease transmission could result in severe financial
impacts on farmers and the destruction of potentially many of thousands of animals.
While EPA had already incorporated biosecurity discussions into basic CAFO
Inspector Training, it was clear that EPA needed to formalize and to reinforce biosecurity
measures. Also, while CAFO inspections could be one avenue for possible disease transmission
by EPA personnel, guidelines were needed for all EPA field activities that could affect livestock.
The guidance was developed in coordination with USD A's Natural Resources
Conservation Service and Animal and Plant Health Inspection Service (APHIS) and the Food
and Drug Administration. We circulated drafts for comment to these organizations, EPA
headquarters offices, regions, states, and academic and industry contacts. The final guidance
relies heavily on and incorporates much of guidance developed by APHIS for USDA employees
on June 21, 2001. My thanks to all who contributed to the development of this guidance.
If you have any questions about this guidance, please contact me or Carol Galloway,
National Agriculture Compliance Assistance Center, at 913-551-5008.
Attachment:
Routine Biosecurity Procedures for EPA Personnel Visiting Farms, Ranches,
Slaughterhouses, and Other Facilities with Livestock and Poultry
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-16
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FIFRA Inspection Manual.July 2002
cc: Sylvia Lowrance, OECA, AAA (w/o attachments)
Rick Colbert, OC/AgD (w/o attachments)
Regional Enforcement Coordinators, Regions 1-10 (electronic only)
National Agriculture Sector Contacts (electronic only)
Eric Schaeffer, Director, ORE
James Makris, Director, CEPPO
Marcia Mulkey, Director, OPP
Michael Cook, Director, OWM
John Seitz, Director, OAQPS
John Chamberlin, OARM, OA
Ty Vannieuwenhoven, USD A, APHIS
Tom Christensen, USDA, NRCS
Julius Jimeno, OARM, OA, SHEMD
Jeff Davidson, OARM, OA, SHEMD
Judy Nelson, OPPTS
Jean-Mari Peltier, OA
Ray Mars, FDA
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-17
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FIFRA Inspection Manual, July 2002
ROUTINE BIOSECURITY PROCEDURES FOR EPA PERSONNEL VISITING FARMS,
RANCHES, SLAUGHTERHOUSES AND OTHER FACILITIES WITH LIVESTOCK
AND POULTRY
This guidance establishes routine procedures to minimize the risk of EPA personnel
transmitting animal diseases from livestock or poultry facilities, including farms, ranches,
dairies, feed yards, sale yards, swine premises, slaughterhouses, and other facilities where there
are animals or unprocessed animal tissues, secretions or excretions (including saliva, manure or
urine, soiled feed, bedding, water or dirt, milk) to livestock or poultry. Often, owners/producers
have adopted more stringent biosecurity measures than these procedures. More stringent
measures might include specific directions on site entry (e.g., showering, changing clothes to
come onto or leave the premises, vehicle washing), or vehicle travel on the site, and other
measures. EPA should discuss appropriate biosecurity measures with the operator prior to
entering animal areas, and are encouraged to follow the more stringent measures.
Separate emergency procedures will be applicable in cases of actual outbreaks of
contagious animal diseases. In such a case, EPA generally will avoid visiting affected areas and
will coordinate with USDA's Animal and Plant Health Inspection Service (APHIS) and local
emergency control authorities concerning activities in these areas. Periodically, EPA will
contact the offices of the appropriate APHIS Area Veterinarians in Charge and the offices of the
State veterinarians to identify any areas with existing emergency animal disease events. The
addresses and telephone numbers of these offices are attached.
EPA personnel should be aware of personal health and safety issues when visiting
livestock facilities and consult with EPA's Health and Safety staff with questions about proper
procedures. Livestock facilities may include OSHA-defmed "confined spaces," e.g., manure
pits. If staff need to enter such areas, all appropriate safety precautions must be followed. In
addition, some animal diseases can be spread to humans, such as brucellosis (bacteria) and
echinococcus (parasite).1 Fortunately, the U.S. largely has eliminated major risk of disease
transmission from animals to humans by a combination of veterinary medicine and State
regulation.
The following procedures are consistent with written procedures developed by APHIS
for use by USD A personnel (June 12, 2001).
Brucellosis is transmitted through contaminated and untreated milk and milk products
and by direct contact with infected animals (cattle, sheep, goats, pigs, camels, buffaloes,
and wild ruminants) or animal carcasses. It is extremely variable in humans. The acute
form (less than 8 weeks from illness onset) may result in nonspecific and "flu-like"
symptoms including fever, sweats, malaise, anorexia, headache, myalgia, and back pain.
Echinococcus granulosus lives on dogs and livestock, and infects humans through contact
with these animals. Allergic reactions and damage to various organs from cyst formation
are the most common forms of disease in humans.
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-18
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FIFRA Inspection Manual, July 2002
Biosecurity Procedures
• Individuals should not make on-site visits to livestock operations if they have visited a
foreign country and were exposed to or had contact with farm animals (with or without a
known contagious disease) within 5 days prior to the site visit. Also, clothing and shoes
worn on foreign farm visits should be cleaned before use on U.S. facilities.
Thoroughly wash hands with soap and water or antibacterial wipes or gel before entering
and after leaving any animal facility. Disposable latex gloves also may be used but not
as a substitute for proper hand washing.
• Park your vehicle on paved or concrete areas, away from farm production sites, to avoid
contact with dirt, mud or manure. If not possible, be certain that tires are free of dirt and
debris by hosing the tires and wheel wells before leaving the premises. If this does not
clean the tires adequately, take the vehicle to a nearby pressure car wash. Including dates
and types of vehicle washing in the vehicle log book is recommended.
Consider using a vehicle supplied by the facility operator for on site travel if available.
Prior to entering the site, put on disinfected rubber boots or other footwear that has been
cleaned and disinfected, or wear new disposable boot covers. The operator may have its
own coveralls and boots for you to wear. However, if visiting only low-risk areas, such
as offices that are located away from animal areas, clean street shoes or boots are
acceptable (hand washing is still needed). [Note: Boot covers may not provide sufficient
traction to safely navigate slopes surrounding lagoons and pits. Personnel may want to
use tape to secure the boot cover to prevent slippage].
On entering a facility, acknowledge any and all other livestock facilities visited within
the previous 48 hours including whether or not EPA entered any animal confinement or
waste storage areas.
• Inform the operator of where the EPA staff wants to go on the site, determine what
biosecurity procedures, if any, the owner/operator has for the on-site locations to be
visited, and determine which biosecurity procedures will be followed for the areas to be
visited.
EPA should only enter animal production buildings if it is essential to complete the goals
of the visit, and should avoid contact with livestock, poultry or other animals (wild or
domestic) on any facility. If close contact with animals is expected, including walking
through narrowly confined pens or lots where animals are within reach, wearing coveralls
is recommended.
• Designate the interior of your vehicle as a "clean area" and keep clean supplies in this
area.
• Designate a "dirty area" of your vehicle, such as the trunk of the car or a specified
enclosed area of a truck bed for double bagged clothes or dirty equipment to be taken off
site.
Before leaving the site, clean and disinfect boots or tightly bag boots for later cleaning.
Scrub boot bottom and sides to remove all dirt and debris, then wash with disinfectant
solution. Disinfectants are not effective on dirt, manure or other organic matter.
• Clean and disinfect equipment if contaminated.
• Use disinfectants that have been registered (or exempted) by EPA for the intended use
(see below). Keep a copy of the label and the Material Safety Data Sheet (MSDS) for
any registered disinfectant used and make both available to the facility upon its request.
Follow all label safety precautions and dispose of empty containers, unused disinfectant
solution, and used disinfectant in accordance with label instructions.
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-19
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FIFRA Inspection Manual, July 2002
• If non-disposable clothing is soiled with manure, blood, milk, or other animal secretions
or there has been close contact with livestock (actual handling or walking where animals
were within reach), before leaving the site, double bag clothing for later cleaning.
Dispose of soiled boot covers, and disposable clothing on-site if acceptable to the
owner/operator. Where on-site disposal is not possible, double bag and tightly seal all
contaminated clothing and gear in disposable bags.
• Inform the owner/operator of the areas of the site that were visited, and the biosecurity
procedures taken. This can be done at an inspection closing conference.
Supplies:
clean boots or new disposable boot covers
- clean change of clothing or coveralls
- appropriate registered or exempted disinfectant (see below)
- water (at least minimum required for hand washing and disinfection)
a bucket or tray to contain disinfectant
long handled brush
clean bags for trash disposal or storage of items to be cleaned
liquid and/or gel antibacterial soap or wipes
- first aid kit including an eye wash
- phone numbers of the State veterinarian or other local officials available in case
you suspect animal diseases are present. Share any such observations with the
owner/operator as soon as possible
Disinfectants for Routine Biosecurity
The following products are currently registered by EPA as being effective against a broad range
of disease-causing organisms, including Foot and Mouth Disease; they are not effective against
all disease-causing organisms. Consult the label information and, if other diseases are a concern,
consult the State veterinarian or State Department of Agriculture.
Virkon S (EPA Reg. No. 62432-1, label and MSDS)
Oxonia Active (EPA Reg. No. 1677-129, label and MSDS)
There are also two household chemicals subject to EPA Section 18 "quarantine exemptions"
(i.e., they are exempted from FIFRA pesticide registration requirements) for use as Foot and
Mouth Disease disinfectants. They are issued to APHIS but designed so that the general public
can make treatments themselves using these chemicals. One permits vinegar (acetic acid) to be
applied as a 4% solution, and the other permits bleach (sodium hypochlorite) to be used in a
solution of 3 parts bleach to 2 parts water. Information on these Section 18 actions is attached.
Attachments:
1. APHIS Veterinary Series Area Offices and State Veterinarians
2. Copies of EPA-approved labels for Virkon S (April 26, 2001) and Oxonia Active
(May 11, 2001) and associated Material Safety Data Sheets
3. Section 18s for Acetic Acid and Sodium Hypochlorite (Bleach)
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-20
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FIFRA Inspection Manual, July 2002
Disclaimer^
The discussion in this document is intended solely as guidance. This document is not a
regulation. It does not impose legally binding requirements on EPA, states, or the regulated
community. This guidance does not confer legal rights or impose legal obligations upon any
member of the public. The general description provided here may not apply to a particular
situation based on the circumstances. Interested parties are free to raise questions and
objections about the substance of this guidance and the appropriateness of the application of
this guidance to a particular situation. EPA retains the discretion to adopt approaches on a
case-by-case basis that differ from those described in this guidance where appropriate. This
document may be revised periodically without public notice. EPA welcomes public input on this
document at any time.
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-21
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FIFRA Inspection Manual, July 2002
APHIS Veterinary Services Area Offices
Eastern Region - (919) 716-5570
Montgomery, Alabama -- (334) 223-7141
Gainesville, Florida - (352) 333-3120
Conyers, Georgia - (770) 922-7860
Springfield, Illinois - (217) 241-6689
Indianapolis, Indiana - (317) 290-3300
Frankfort, Kentucky - (502) 227-9651
Annapolis, Maryland - (410) 349-9708 (also serves DC & DE)
Sutton, Massachusetts - (508) 865-1421 (also serves CT, ME, NH, RI & VT)
Lansing, Michigan - (517) 324-5290
St. Paul, Minnesota - (651)-290-3691
Jackson, Mississippi - (601) 965-4307
Robbinsville, New Jersey - (609) 259-8387
Albany, New York - (518) 453-0187
Raleigh, North Carolina - (919) 716-5570
Pickerington, Ohio - (614) 469-5602 (also serves WV)
Harrisburg, Pennsylvania - (717) 782-3442
San Juan, Puerto Rico - (787) 766-6050, 6055
Columbia, South Carolina - (803) 788-1919
Nashville, Tennessee -- (615) 781-5310
Richmond, Virginia - (804) 771-2774
Madison, Wisconsin - (608) 270-4000
Western Region - (817) 276-2201
Little Rock, Arkansas - (501) 224-9515
Tempe, Arizona - (480) 491-1002
Sacramento, California - (916) 857-6170 (also serves NV)
Englewood, Colorado - (303) 784-6229
Denver, Colorado - (303) 231-5385
Honolulu, Hawaii - (808) 861-8560
Boise, Idaho - (208) 378-5631
Des Moines, Iowa - (515) 284-4140
Topeka, Kansas - (785) 235-2365
Baton Rouge, Louisiana - (504) 389-0436
Jefferson City, Missouri — (314) 636-3116
Helena, Montana - (406) 449-5407
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-22
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FIFRA Inspection Manual, July 2002
APHIS Veterinary Services Area Offices
Lincoln, Nebraska -- (402) 434-2300
Albuquerque, New Mexico — (505) 761-3160
Bismarck, North Dakota - (701) 250-4210
Oklahoma City, Oklahoma - (405) 427-9413
Salem, Oregon - (503) 399-5871
Pierre, South Dakota - (605) 224-6186
Austin, Texas -- (512) 916-5551
Salt Lake City, Utah - (801) 524-5010
Olympia, Washington - (360) 753-9430 (also serves AK)
Cheyenne, Wyoming - (307) 772-2186
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-23
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FIFRA Inspection Manual, July 2002
State Veterinarians
ALABAMA
Phone: 334-240-7255
Fax: 334-223-7352
Dept. of Agriculture & Industries
Animal Industry Division
P. O. Box 3336
Montgomery, AL 36109-0336
ALASKA
Phone: 907-745-3236
Fax: 907-745-8125
500 S. Alaska Street, Suite A
Palmer, Alaska 99645
ARIZONA
Phone: 602-542-4293
Fax: 602-542-4290
Arizona Dept. of Agriculture
1688 West Adams
Phoenix, AZ 85007
ARKANSAS
Phone: 501-225-5138
Fax: 501-225-9727
Arkansas Livestock & Poultry Commission
One Natural Resources Drive
P. O. Box 5497
Little Rock, AR 72215
CALIFORNIA
Phone: 916-654-0881
Fax: 916-653-2215
CA Dept. of Food & Agriculture
1220 "N" Street, Room A-114
Sacramento, CA 95814
COLORADO
Phone: 303-239-4161
Fax: 303-239-4164
700 Kipling Street, Suite 4000
Lakewood, CO 80215-5894
CONNECTICUT
Phone: 860-566-4616
Fax: 860-566-8791
State Office Building, Room 291
165 Capitol Avenue
Hartford, CT 06106
DELAWARE
Phone:302-739-4811
Fax: 302-697-6287
Delaware Dept. of Agriculture
2320 S. Dupont Highway
Dover, DE 19901
FLORIDA
Phone: 904-488-8280
Fax: 904-487-3641
Florida Dept. of Agriculture
Division of Animal Industry
Room 32B, Mayo Building
Tallahassee, FL 32399-0800
GEORGIA
Phone: 404-656-3671
Fax: 404-657-1357
Dept. of Agriculture
Capital Square
Atlanta, GA 30334-4201
HAWAII
Phone:808-483-7111
Fax: 808-487-5789
Hawaii Dept. of Agriculture
99-941 Halawa Valley Street
Aiea, Hawaii 96701-5699
IDAHO
Phone: 208-334-3256
Fax: 208-334-2170
Bureau of Animal Health
128 Klotz Lane
P. O. Box 7249
Boise, Idaho 83707
ILLINOIS
Phone: 217-782-4944
Fax: 217-524-7702
Division of Animal Industries
State Fairgrounds
P. O. Box 19281
Springfield, IL 62794-9281
INDIANA
Phone: 317-232-1344
Fax:317-232-1330
805 Beachway Drive, Suite 50
Indianapolis, IN 46224
IOWA
Phone: 515-281-5305
Fax: 515-281-4282
Bureau of Animal Industry,
IA Dept. of Ag. & Stewardship, Henry Wallace Bldg
Des Moines, Iowa 50319
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-24
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FIFRA Inspection Manual, July 2002
KANSAS
Phone: 913-296-2326
Fax: 913-296-1765
Livestock Commission
Anchor Savings Building, Ste.4B
712 Kansas Avenue
Topeka, Kansas 66603-3808
KENTUCKY
Phone: 502-564-3956
Fax: 502-564-7852
Division of Animal Health
100 Fair Oaks Lane, Suite 252
Frankfort, Kentucky 40601
LOUISIANA
Phone: 504-925-3980
Fax: 504-925-4103
P.O. Box 1951
Baton Rouge, LA 70821
MAINE
Phone: 207-287-3701
Fax: 207-287-7548
Div. of Animal Health & Industry
Dept. of Ag., Food & Rural Res.
State House Station 28
Augusta, ME 04333-0028
MARYLAND
Phone: 410-841-5810
Fax: 410-841-5999
Div. of Animal Industries
MD Dept. of Agriculture
50 Harry S. Truman Parkway
Annapolis, MD 21401
MASSACHUSETTS
Phone: 617-626-1700
Fax: 617-626-1850
Department of Food and Agriculture
Bureau of Animal Health
251 Causeway Street, Suite 500
Boston, MA 02114-2151
MICHIGAN
Phone: 517-373-1077
Fax: 517-373-6015
MI Dept. of Agriculture
Animal Industry Division
P.O. Box 30017
Lansing, Michigan 48909
MINNESOTA
Phone: 612-296-2942
Fax: 612-296-7417
Executive Secretary,
Board of Animal Health
90 West Plato
St. Paul, MN 55107
MISSISSIPPI
Phone: 601-354-6089
Fax: 601-354-6097
State Veterinarian
Box 4389
Jackson, MS 3 9216
MISSOURI
Phone: 573-751-3377
Fax: 573-751-6919
Div. of Animal Health
MO Dept. of Agriculture
P. O. Box 630
Jefferson City, MO 65102
MONTANA
Phone: 406-444-2976
Fax: 406-444-1929
MT Dept. of Livestock
Animal Health Division
Import/Export Section
P.O. Box 202001
6th & Roberts
Helena, MT 59620-2001
NEBRASKA
Phone:402-471-2351
Fax: 402-471-3252
Dept. of Agriculture
Bureau of Animal Industry
P. O. Box 94787
Lincoln, Nebraska 68509
NEVADA
Phone:702-688-1180
Fax:702-688-1178
Dir. Div. of Animal Industry
State Dept. of Agriculture
P.O. Box 11100
Reno, NV 89510
NEW HAMPSHIRE
Phone: 603-271-2404
Fax:603-271-1109
NH Dept. of Agriculture
Div. of Animal Industry
P. O. Box 2042
Concord, NH 03302-2042
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-25
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FIFRA Inspection Manual, July 2002
NEW JERSEY
Phone: 609-292-3965
Fax: 609-633-2550
Dir, Div. of Animal Health
NJ Dept. of Agriculture
CN330
Trenton, NJ 08625
NEW MEXICO
Phone: 505-841-4000
Fax: 505-841-4012
New Mexico Livestock Board
7013 Central Ave., N. E.
Albuquerque, NM 87108-2049
NEW YORK
Phone: 518-457-3502
Fax: 518-457-8892
Div. of Animal Industry
NY St. Dept. of Ag. & Markets
1 Winners Circle
Albany, NY 12235
NORTH CAROLINA
Phone: 919-733-7601
Fax: 919-733-2277
North Carolina Dept. of Agriculture & Consumer
Services
Veterinary Division
P.O. Box 26026
Raleigh, NC 27611
NORTH DAKOTA
Phone: 701-328-2655
Fax: 701-328-4567
ND Board of Animal Health
600 E. Boulevard, 6th Floor
Bismarck, ND 58505-0020
OHIO
Phone: 614-728-6220
Fax:614-728-6310
Chief, Div. of Animal Industry
Ohio Dept. of Ag.
8995 East Main Street
Reynoldsburg, Ohio 43068
OKLAHOMA
Phone: 405-521-3891
Fax: 405-522-4583
Animal Industry Div.
OK Dept. of Ag
2800 N.Lincoln Blvd.
Oklahoma City, OK 73105-4298
OREGON
Phone: 503-986-4680
Fax: 503-986-4734
OR Dept. of Agriculture
63 5 Capitol Street NE
Salem, OR 97310-0110
PENNSYLVANIA
Phone: 717-783-5301
Fax: 717-787-1868
Dir., Bureau of Animal Industry
PA Dept. of Agriculture
2301 North Cameron Street
Harrisburg,PA17110
RHODE ISLAND
Phone: 401-277-2781
Fax: 401-277-6047
RI Dept. of Environmental Mgmt.
Div. of Agriculture
Roger Williams Building
22 Hayes Street
Providence, RI 02908
SOUTH CAROLINA
Phone: 803-788-2260
Fax: 803-788-8058
Clemson University
Livestock-Poultry Health Division
P. O. Box 102406
Columbia, SC 29224-2406
SOUTH DAKOTA
Phone: 605-773-3321
Fax: 605-773-5459
Animal Industry Board
411 South Fort Street
Pierre, SD 57501
TENNESSEE
Phone: 615-360-0120
Fax: 615-781-5309
Ellington Ag. Center
P. O. Box 40627, Melrose Station
Nashville, TN 37220
TEXAS
Phone: 512-719-0777
Fax: 512-719-0719
TX Animal Health Commission
2105 Kramer Lane
P. O. Box 12966
Austin, TX 78711-2966
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-26
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FIFRA Inspection Manual, July 2002
UTAH
Phone: 801-538-7160
Fax: 801-538-7169
Utah St. Dept. of Agriculture
3 50 N. Redwood Rd.
P. O. Box 146500
Salt Lake City, UT 84114-6500
VERMONT
Phone: 802-828-2421
Fax: 802-828-2361
Dept. of Ag., Food & Markets
Animal Health Section
116 State St., Drawer 20
Montpelier, Vermont 05620-2901
VIRGINIA
Phone: 804-786-2481
Fax: 804-371-2380
Dept. of Ag. & Consumer Services
Division of Animal Health
Washington Building, Suite 600
1100 Bank Street
Richmond, VA 23219
WASHINGTON
Phone: 360-902-1878
Fax: 360-902-2087
Dept. of Agriculture
Food Safety/Animal Health Division
P. O. Box 42577
1111 Washington St.
Olympia, WA 98504-2577
WEST VIRGINIA
Phone: 304-558-2214
Fax:304-558-2231
Dir. of Animal Health Programs
WVDept. ofAg.
1900 Kanawha Blvd., East
Charleston, WV 25305-0170
WISCONSIN
Phone: 608-224-4873
Fax: 608-224-4871
WI Dept. of Ag., Trade & Consumer Protection
Animal Health Division
P.O. Box 8911
Madison, WI 53708-8911
WYOMING
Phone: 307-777-7515
Fax: 307-777-6561
2020 Carey Ave., 4th Floor
Cheyenne, WY 82002
PUERTO RICO
Phone: 809-725-1685
Fax: 809-723-6199
Dir., Vet. Services
Dept. of Agriculture
Commonwealth of Puerto Rico
Box 10163
Santurce, PR 00908
VIRGIN ISLANDS
Office of the Commissioner of Agriculture
P. O. Box "U"
Kingshill, St. Croix, USVI00850
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-27
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FIFRA Inspection Manual, July 2002
f—
[ ] indicates oplbnal language
EQUINE BACTERIA
Cbsiridium pcffriflgens
Fisftttous withcra (Pall Evil)
Streptococcus equi (Strangles)
Pscodflmfflas mate
(Glanders)
BqcttettUa broochittptica
EQUINE VIRUSES
African Horac Sickness
African Viral Arteritis
(Pink Eye)
! Exanthema
Equine Infectious Anemia
(Swamp Fewer)
Equine papiJIomfltosLS
Equine CfflESagious Abortion
Adenoviras Pneumonia
Equine Influenza (The Cou|}i)
EQ'UINE FUNGI
TrkJ»pliyK»spp. (Ringwonn)
Tricbqshjton spp,
(Mud Fevei)
Fusamun monilifDim;
BOVINE BACTERIA
Moraxdk bovis
Mycobsctcrimn bovis
Hactncf bilus sumiiiis
BOVINE VIRUSES
Calfrouvims
RtuiKitnicbdtis
Bovine AdeKwmB Type 4
Pseutesbks
Fo« & Moudi Distase
EFFECTIVE AGAINST:
POULTRY BACTERIA
Strqitocoocus pyogews
Ktabsieth paeumoakc
Egchcridw coli
Sahnoneto typhimurium
Satemdto ehoto^uis
StaphylococctiS aureus
Stiiptiylococxus epidcrmi Jis
MycupLasnia p(ta{>ticuni
Boi tedli avium
POULTRY VIRUSES
Wotwoi Bronchitis
Int'ertious Bursal Disease
A vUn Influenza
Mark's EHsease
Egg Drop Syndrome
Adencmnts
Turkey Hwp« Virus
Duck Herpes Virus
Duck VM! Enteritis
POULTRY FUHGi
avus
Aspcrpllus fumigatua
Candida
Pagc 2
SWTNE BACTERIA
Bordddla bronclustptica
ActinobaciDus
Trcponcma bjwJysentwk
ClostrwJiwn
SWINE VIRUSES
Hog Cholera
Swine Influenza
Rfaa^ira! da-nhet
Vffikwtar
Porcine Reproductive and
Respbatory Synrfroira:
(PRRS)
Afrkan Swine Fever
Foot and Mouth Disease
SWINE FUNGI
Fusariwn monilifunix
COMPANION ANIMALS
BACTERIA
Sorepwcoocus iiircus
Streptococcys pyogcnfis
Psewdomooas »eragii»sa
VIRUSES
Canfac parvowus
Distemper
ira cankola
Feline hope
Feline calicivirsB
FUNGI
BOVINE FUNGI
c:\antec\Virkon S \tbel proposal 25 April 2001.wpd
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-28
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FIFRA Inspection Manual, July 2002
indicates optional language
}>\r
Page I
I 1.
VIRKOK^S*
BROAD SPECTRUM DISINFECTANT
For Use in Cleaning and Dtsmfecfrg Mistrial Animal and Agricultural Facilities
ACTIVE INGREDIENTS:
Potassium peroxyiminosulfele • •• - 20.4 A
Sodium Chloride L5%
INERT INGREDIENTS , .........,. — . 22JS
TOTAL _ „.,. ., 100.00%
Equivalent to 9.75% Available Chlorine '.' ; i
KEEP OUT OF BEACH OF CHILDREN
DANGER
SeeBaek [Side] Pand[t] for Addttknal Precautions
Weigh!
EPA Esl. No. 62432-EN-OOl
EPA Reg. No. 62432-!
ANTEC INTERNATIONAL LTD.
WindhamRoad, CMtton Industrial Estates
Sadbury Sirffolk 0010 6XD, Gnglaud
Tel: (1787) 77305 Tetec 987495 Fax,: {1787)310846
V1JOCON S is a registered trademvfc of sad mamfactured % Antee Inicroational Lknited
USPatBBtNo-4822512
ACCEPTED
APR 2 6
AO at vmtei to at
c:\anlec\Viiicoa S labd proposal 25 April 2001 >wpd
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-29
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FIFRA Inspection Manual, July 2002
| indicate* optional language
Page 3
PRECAUTIONARY 'STATEMENTS
HAZARDS TO HUMANS ANI> DOMESTIC ANTMAI.S
DANGHl
Powder is corrosive Causes skin bums and brewreibte «ye dama|«. Harmful if swallowed, absorbed through
skm,orintat«L Da not get in eyes, on skin, or OB etehttg. Wat protective clattung and robber gtoves. Awid
War goggte, tee shield, or safety ffcssw, W»sh tfaor oughly with soap and rater afte hudl
contattUMrted clothing and wash before raise. OwroreE suicmcm refers to powfcr «nty not m
olution. ^
IF IN EYES: HoW eydids (*cn and flush with a stea% patte stream of watw for 15 minutes. G& prompt
medical sttcnttofi.
IF ON SKIN: Wash witii ptatty (rfsoap awl waiter. Get iwifical attention if irrtoignposiste
IF INHALED- If symptoms afcougm. chote^, or wteaang arc trnutolesome, romove lo fresh mi ami seek
dfcal attwtiwL
IF SWALLOWED: DrMcproiiiitlyslaifeqoH«iiiyofwB». Avotdakohd- G« immafiate niHfital a«Ht»oa
NOTICE TO PHYSICIAN:
BROAD SPECTRUM DISINFECTANT
VIRKON-S is rffedivc agjiinst mHnaMi miciwwpafaras affeaing animals: viruses, gywri poaitiw and gram
negatiw bacteria, fimp (»Ate and yeasts), and myeopbsma. Efficacy was determined in tiw pr^aow of hard
water and orgatuc material. VtRXON-S passe* Ou AOAC germicMal md Jiiergait wnte^ tea a *
conctHtrmtion ofQ.i% (1:2(10) ia Hit proem* 0f2Q9ppm **frf miter.
DIRECTIONS FOR USE
Fasteral law ptrohibiis use of tMs praJuct ba amexf "axxmistetx with te labeling
Tlw powder fonimla is easily diluted for use in manual 01 machine operations.
VIRKON-S DILVnON CHART
Fill ^irtatoer wM -Wwrf fl»M«J« */t«*r «^ ««* VOU0N4p**er to ac*&wf «w*«fiw»« «rf««w
aj Wafer
Amount af Pfnv&r&f /*
/vr 2% Solution
1 Gallae
2.? ounces
26,7aamott
SOGaHims
I.J PI. J
c:\tatecVVirkon S label proposal 25 April 20Ql.wp4
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-30
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FIFRA Inspection Manual, July 2002
indicates optional language p . 4
AM fl.3 «, (i temp) ofVWKON~SI fthe atnte»tt */«•* VIKXON^pu*
warm water. Sotutiffm ant stable far 7 days. Da not soak metal objects for
minute* ti maximum necewvy amUet ti*& One gallm ofsobtwm is mffuient » treat I3S w
ft
POULTRY [AMD RAT1TE PRODUCTIONl
CONTROI S- Viruses of Newcastle Disease, Infectious Bronchia is. Infectious Borsal Disease, Avian
Larvngotmheitis, Msrek's Disease, Egg Drop Sy«ta«, Avian Irfhicna, Turkey Herpes Vmis and
Duck Vkal Enteritis. Fungi «us qridcnnMis, Bontetdla avium ami Mycopksna
gaDiscptiouni.
HATCHFRIES • V11KON-S at I % sotatioo, cm be used For cleaning and defecting natcberi. setters,
evaporative coo'lm. hTOMftmg ^stcm^cefliag to,chJckflilraB«, trusftrmieks, trays, wdptotic
cU* boxes (use 2% sotatkm for Mycoptena, AipKgihiS tews and Aspergilte tanpto).
VIRKON-S ai M« sflft^fl is recommendfid for we « (wet raisting) opmtWDS «s a
wpptemmtal measure, either frcfw* » *fer repSar doming a«i dMmftamg proMdwe. Fog (wet
m£t) untfl the ana is noiA using toteraatB foggas iccordini to nwnufactwcr's
RROILBR/BREEDER HOUSES; Rem*** chickens /«rth|,/««t and water troughs, iheit nmeve
^^reandUti^Spr^fl^amfwOMwrn vaOUHt&«l%*M»*. n»»u0iljrw«(hw*ei«
and feeders with a 1% solution of VIRKON-S (me2% sotattai for Mycoptemi, A^erpllus tovusaad
Aspcrplte fonugatus).
until treatment Ms rfrferf.
FOR AIR SANITIZTNG^ UK VIRKON-S at 1-2% solution, and fog until suifiwes are moist. Altow
at kart 2 hours before entering ttwte* a«ff. SiitM/egger* art spr^m with water Uvmn me.
PROCESS [NO PLANTS; Spray VWKON-$a /Ksmbituw » dininfca and clean walls, eeffi
SWINE tPRODUCTlOK]
CONTROLS- Viruses of Hog Chokra, Swioe influenza. Porcine Parroviras, Pseudorafcs, Porcine
Reproductive and Respiratory Syndrome (PRRS), Jtotowal Diaithea, African Swine Fever md Foot
and MoaA Disease. Bacteria of Ftanupnasncaa, Treponem hyodyseolenae. tad Ctastndmm
Fungi" FusarMin
V1RKOH-S ttt I % sototiem is recommended far dsonHif
-------
FIFRA Inspection Manual, July 2002
3 y
] indicates optional language . ? ,
„,,,„ tHSaeH^aOO^li^MSSf
^gquipmetf a&iMfennflttte
VIRKON-S « MX M»torw* is recommended for use in fogs«g (wet muting;) operations or as a
jHMfeiiMttfn«0M» either*^* or ^nrrepibrckaning and dhmf^img procedures. Fag
(WimM} until the area is moist using twtomrtk fbggm according to manufacture s use dncnoos.
Rittse/aggers and sprayers wifh maerf&ttirwtog use-
EQUINE [FRODUCT10N1
BROAD SPECTRUM EQUINE DISINFECTAKT/DtTERGANT/WASH FOR CLEANING AND
DISINFECTING STABLIS, EQUIPMENT. AND AERIA1, DISINFECTION
UUM 1 KUl'A _ , , _ ,
Vimscs of Afrfcan H«e Skknets, Eq«i« Viral Aitertis (Pink Eye), Oo«il Eunlhenna, _
nitis, Equine Cortagk^us Abott^n, Equ« PapitaatoSl3
,
k (S««p Fewr), AtooWtB PK^eia, E^c Infl™ (The_
: i,
ica, Str^tocoow epi (Stwgte) ^ P^udonH^ ndki CCta-te*
sis Rinwo™), Dennatopl^sis (MuJ Fcvs), and Fusummi mornhforrr*.
Fungi; Dermatopkytosis (Ringwo™
APPLICATIONS: For cfcatjiflg and rfm*/**** «D siirfeces, equipm^t, utensib and instrament* «
Vctciimry jwacticcs [, kennels, stabtes, catties, etc].
USES:
Stabks, [Horse Box«, UBox ]SlaIU, T«k ,[Eq«ip««t] a«J Ferf Roo««^ Tto««ghly e
Ay [dry clean] apfaea. tbcn wash the area msnnaDy or wih pressure waster with a I -
S solution. Rinse with clean water.
Blankets, [Saddle Pads] [and] Rugs Shampoo by tad or sptay ligluly wrtb a taod-spraycf wd
. Shake or vacuum to remove residue-
irtft>to« «•&
octa
fint thing in the morning aod tost ttog at nin»t]. RP«* spnv«rt *fifc wn»r o/ter we.
BOVINE [PRODUCTION]
CONTROLS: Viruses of Calf r
-------
FIFRA Inspection Manual, July 2002
6 ; 6
| indicates optional kngjiage
Page 6
COMPANION ANIMALS
CONTROLS- Viruses Canine Parrovirus, Distemper, Leptespira csnicola, Feline parvovirus, Feline
hope* and Feline calkmros. Bacteria of Sttphytoeoccw roreus. Streptococcus pyogcnes, Klcteidb
pncwmomae, and PsoKtomonas acwgioasa; Fungi of Miero&porum cams.
[APPLICATIONS:] ^ 1% mtuttea o/VIRKOK-S is reoommendcd as a "one step" cleaning awl
disinfecting procedure for all surfaces, equipment, instruments, utHuk and c«f«i [eaging
MEtOTsl^hin [associated wkhJ[VetcTiiaiy Medkd Hospiub,] [tafecttoan d«3« wante,]
[quarantine BrtasJ [Hunane Society facilite,] [laborHwy animal quarters,] groommg md boarding
facilities, kunuiels, catteries and animal tnnsportatba vehicles.
Do aot .nmmc n«tal objects in V1RKON-S for long periods - 10 minute, is maximum contact time.
-
STORAGE AND DISPOSAL
STORAGE: Store:in i cool dry pkee in tigjttttr eterf coniafaier away fiom cWWrcn, Always
repbcc Ud after use, ,
DISPOSAL: Wash empty container thoroughly and dispose in trask Do not mix tliis product wtth
other Aemkab
S label proposal 25 April 2001 .wpd
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-33
-------
FIFRA Inspection Manual, July 2002
UNITED STATES WtVtSQNMiNTAL PROT6CTIOH
HAY
im\
c
Ecolab
Ecolib Inc,
370 M Wabasha Street
St. Paul, MK 55102-13 90
Attention: John G, Wood, Director
Product Registration and Compliance
Subject: Oxonia Active
EPA Registration Number 1677-129
Amendment Dated April 6,2001
The Agency is conditionally approving yoar amendment to the registration of the product
referenced above under authority of FIFRA Section 3(c)(7)(B), This amendment allows use of
the subject product as a viradefc against the animal pathogen "Foot and Mouth Disease
wr ]^
fc^TE ^
ecu e^««.
r— ~~r_^ . OPFIOAt FILE CWIf
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-34
-------
FIFRA Inspection Manual, July 2002
Page 2
C. The performance standard is total inactivarton of ihc vims 01 a 3-log reduction if
CjTOtoxicity is present,
A stamped accepted copy of the label is enclosed for your records.
If you have any questions concerning this letter, please contact Manha Terry at (703) 30$-
6217.
Sincerely,
Marshall Swindell
Product Manager 33
Regulator)' Management Branch I
Antimicrobial DMsion(7SlCC)
Enclosure
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-35
-------
FIFRA Inspection Manual, July 2002
OXONIA ACTIVE
ACID UCKJ1D SAMTIZER FOR FOOD PROCESSING EQUIPMENT
in Dairies, Dairy Farms, Breweries, VWnwta, Beverage and Food Processing Plants
AGIO LIQUID SANITffiR FOR SANITIZING TABLEWARE
DISINFECTANT .
Hospitals Health Cars FadWa*, AntoneJ Care Facitfties. Veterinary Facilities, Farms,
' Livestock Quarters, Poultry Pwmsws, and Pguttry Hs*c-henes
Active Ingredients:
WpSrogen Peroxide
Perowacetc Acid
Irwrt Ingre
DISINFECTANT FOR THE PHARMACEUTICAL AND COSMETIC INDUSTRY w^{JcOMNraitTS
in EPA Lester Dated:
HAY 1 i 20gf
UmMr itiE federal Inseenclde,
V'uiitfic/it, md Rade:il:;-j;ii- Aei e-
KEEP OUT OF REACH OF CHlLORiN
DANGER
PRECAUTIONARY STATEMENTS -HUNK* TO HUMANS ANDpOMEgTCAMMALS
DANGER- CORROSIVE; Causes iirewrs«*i wedsmafl* and sfcin bums. May be trial If ir
absorbed Birouoti the skin. Harmful if swallowed Do not get to eyes, on skin or on doming.
breathe vapcrf or spray mist. Wesr protect** eyeweaf (aogflles, face shield, or safety 9Bs»- -
etoteng andriAber gtov«, Vfeh therou«% »ter hanlng witfi soap and water and befowrahng,
dSl oTwSSto&co. Remova contAiintfW CksWng ami wash cbtiing bt*x»«u6tWMr a mask
or p3ie respirator jointly approved by Mim Sifey and Heal'.h Admini£lf*on and Iha Nalionrt Insbtjl
tor Occupations^ Safe^ and Health.
STATlMSNT OF PRACTICAL TREATMENT , _.„....„ /»_,,
F IN EYES: HoW eyslicl* Open trtd Suah wflh a *le»dy, gentte stream of water lor to rnmines. ww
IF ON SKIN- Wish wlih plenty of soap and water, Grt medieal attswllon, ... «, t
IF M4ALED: Remow"vSbmto. Irish air, If not breathing, gi« ar«k»l respiration, preferably moyth-to-
registered under ERA teg. No
mlJ.^., ^« «,. - -— -r get mortcal attention. Do not induce vomttirKi or gwe anyltiwa by
to an unconscious person. Drink promptly s laro« quantity of m,lk egg*"^cSt^r^mra'
- -'i dnriklaraequamfcaofwBtir. Awd alcoho1 CALL A POISON CONTKUL
NOTE TO PHYSICIAN: Probable rnwwsal t»ma®« may coRtroindicate lr» use of gastric lavsge
PHYSICAL AND CHEMICAL HAZARDS: Strong oxMlzlrw aflent Corroai«. Do not use in conewUraled
Sm wS only with water accoftfing to tatei insmicBons. Rever bnrfl concMtralt n conteci wnn citwr
sanssizers, cleaners or organic substances.
ENVIRONMENTAL HAZARDS: Do not discharge effluent containing tnis product into takes, streams,
rrJL "«„ ..^ ^»ars or other Waters urfess in ao»fdance with the requirements of a NaiMal
hame Elimination System (NPDES) p*fm« and permitting a-jjhortty has been npbted in
or to teharge. Do not discharge efflwint containing mis product to sewer system* wiihwt
v.=™u,.y notifying the toe* iewag* trMtewrt ptant authority, Fcr guidance c0r*aet your State Vteter
Board or Regional Office of the EPA.
FOR COMMERCIAL USE ONLY
STRONG OXIDIZING AGENT
EPA R»ft, N.
EPA E«t. 1ST7-MN-1 (PJ, 6S1S6-IL-
1677.TX-KD). l6T7-dH.l{H),
ie77-PR-t(B), 1877-CA-1(S),
reNss to first teltef «f date ocde
. 1617-WV-1{V)
Mel Contents:
1 U.S. Gal. (3.7BL)
4 U.S. Gate. (15.1 L)
2 5 U-S. Gal&.
15 U.S. Gals, (58.8 L)
30U.S Gils, (113.5L)
BOU.S.GA- (1BSL)
300 U.S. Gals, flflte)
Eoolab Food and Beverage OMsicn
EocW> Inc., 370 N. Wabariw Stwct
SL Paul. MN 55102
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-36
-------
FIFRA Inspection Manual, July 2002
C xon ib Active las*! Pegs 2 APr£; e • *c'"' '•
It is' a violation ol Federal taw 10 use ttife product in a manner inconsistent with tts labeling.
SANtTIZATlOH
Ononlt Actlw »cid tanlfeer is recommended for us* on pre-cfeanod surtsws ufihas ^P™"1-
BiDeKnes ante vats Mtere fvapanrtws, pestourte** and esapbe equipment m dairies, |*flw«?*s. .
Knes teSeragr^d food pm»a.ng pfenfe This product is tftcftw as a tanltinr when s^ton H
prepared in water of up to 500 ppm hardn««s as CaCos,
then «* w* a d*r gent £*», ££» . , -«.
wHterrnw Sanitize with • wncertalion oH ,3 to 2.0 omces Omrriii A^H M(T7
™tef (0.25 - 0,4% vAf concentretBn), At Ws dButton Ctonla Active is effect^ jiaiwt
BUr«us, EscterfeWa cof. &rf» ns Salmwete
P»«^nori« aerngwosa and V
immsrsran ooame s
we«mw», P«ft6eooca5 amflosusan .,
ow w circula1ie« tectm«3|w$ as appropriate to the eqyipmenl AH surfaces sftfj"*
npmd to w ana&ing solufai fef I perked w* lest than tafl minutes unless otnerwse sp«dfl^ by
governing taniilwy code. Drain thoroughly and allow to air dry. Do not rinse.
SANITIZING EATING, ORINKING.ANQfQPP PREP UTENSILS
1. Remove gtoss food partitas 6y a pmscnpe, preflush and. when necessary » presoak treatment.
2. Wa&h with a recommended detergent
3 Rinse with clem water.
4. Sanitize in a solution of 1.3 to 2.0 oe QxonU Ae*v« to 4 gaBcm of water. I mrwwsft ai utensils tor
ot least 1 minute or contact time spaclfW by governing sanitary code.
5 Drain and air dry.
ELCVM'EO TEMPERATURE SANITIZING.
for sgnrtiza'Jon of eotuipmens in food processing plants, restaurants, eto, dean and nnse eqyipffwro
•Jiorooghly At a temperature d t20 deg F, Oxonta Aethw is an eflecBve santeer for food ccntac*
surfaces at a concentration of 0.1% to 0-28% w/v (1 to 2.8 oz. Oxonia Actiw to 8 gallons water) gainst
Siapfiyi'ococws auntus and EscfwricWa coff. AH frurtac»s should be exposed to th» sanlllzing sduten tor
a period of rw! less thin 1 minute A)iow equiprrwnlto drain ttiDfougritjr.
S.ANITIBNS TABLEWARE
tor santWing taHe
rinsi wate" at a OOf
3.28% v/w. Airdiry.
Tt? insure ttiat Ihe Oxonli Aetw» sanitMr concenlraton does not fall below 0,1%, pBrtodteally tot the
Free solution with a sutebte tesl KM a^ adjust tt* dispensng rate accordingly. Consult your local Ecoab
Specialist to tediniCBl assistance »nd furthar InfonTraSon on sanitizing tableware in ware-washing
machin*s,
FIMAU SANITIZING BOTTLE RlhiSE
Oxonte Active may be used as a final sanitizing rinse fw returnable and rwn-retumable botttet at a 0.2S%
dilution (V3 oz to 4 gallons).
NOTE: FOR MECHANICAL OPERATIONS prepared use sotjlioo miy not be reused tor &awtizing but
mav be rtusid for o4her purposes sue* as cleaning. ,,_,., <. «
FOR MANUAL OPERATIONS tesh santtiE^ig »imksns should be prepared a« least daily or raore often if
tie solution becomes (Muted or soiad.
ft3CEPTEI)_
>MMf
'
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-37
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FIFRA Inspection Manual, July 2002
Qxcmia Aclrvc \atx:: Pa^e 3 ^Prv t. 20C1
SANmyiNG NON-FOOD CONTACT SURFACES M „ , _
Plictear surfaces E* directed abort. Sanitize non-food contact surfaces SIK* a* ftoocs, waJs, tables,
chairs benches Organs, troughs. ar>d onp pans with 1 oz Ononla Activs pur 6 gi water, At this
concent'Ston the product is dteetwe against SJaptytoeoosus eurtus. E/rt»Joe»eter Bsrogeiws,
Eschcu-teftJa cod Lisiem tmnocytogerms, Sa*mo*idta jypWrmiriun). Ps^waomcnas aomgrnosa. end
Saortsromyces cw»vsifle Al-so effective againsl organism* found in the brewing Musty, Psctoeoaas
ex carefwJty proteclBd. Fog «»slred areas usitt) one quart per 1000 cuJI. of room
area with a 0 3% to 3,0% (3 oz. lo 3C on. per 8 gifofts of water) OKOitia Ac«¥* sfllutton Vwate the araa
gf all p*f«onnel during toflQinfl and until «n« hydrogen p«oxld« air concentration is b*nv 0,5 ppm. . Atiew
surfa«s to drain thorough!* betore opervfons art nesumed. Solutions above 0.5% may be corrowve and
are nd to be used on all syrt^es, Tesl sduton* on surfecss prtcr to us«^
SANITia.NG. NON-FOOD CCHTTACT PACKAGING EQUIPMENT
Prior to use'rM this product. fEmove grew soil paietes from surfaces. Wash with a recorrmenoao
iSetergent soSuticn, rinse thofougniy with poMsli wattr. For sanitaaliw- agalns? beverage spolase
organisms that indude Perfwwccus damrtosiB. Lac«^«£*Js mate/wroenfflrw, and Sa(xnww»r)«ea
cerevis/se app-lf 0,5 - 4 ,0% (5 oi. to 40 ca. p«f 8 ga*sns of water) of Oxonla Actiw* to surfaces at a
t*mp«ra*ure d 25 to 46 d^ C and allow to remain wet for at feast S minutes. Alto* surfaces to drain
trwroughly before operations are resumed. Drakiaga may be followed by a potabie or steflle water nnse.
SANITIZE PRECIEANED OR NEW RETURNABLE OR NON-R El gRNABLE CON7AINEBS.
To sanitize pf«cleaned or new returnable Of non-retumatile cor.tain*rs app^y Oxonl* Active at a
cence^lfation of 1 .C% to 4.0% (10 « to 40 oz. par B gallons or wais*) at a ternoorature of 40 to 60 oeg t,
for at least 7 &eeomJs At these conditions. Oxenla Active is effective agalns; Stupbytocaccus surew-s,
Eacnenc/iw oofr SalntanaHa SyptH. PBs»ocooo» (femnosus, Lacfoosa'ft/s ma^romenfans, and
Saceftei'Qm.ycfls cer»wt»o. After thorough draining, nnse interior container winaces with sterie or
polable water.
ANTIMtCROBIAL TREATMENT OF WAUgflLTERS
Tc reduce the numW or beverage ^ilaSe grgan&ms Shat Include Psrfiocosous damnosus, ,
maiefenTWfjfans and SwcJwomyees cemi^iaiM appry Oxonla Active as a 0 5 to 2.0% (5 02. to 20 oz.
p«r e gallons of water) solution at 25 te 45 d« C for a minimum contact time of S maiulfis, AJter thorou§h
dsr aming. raise filters with potable or sterile water.
AKTlM
-------
FIFRA Inspection Manual, July 2002
C.'*cr;EAc?ivttibe' f'age^ April C-.20CJ'
DISINFECTION
Qxonia Active disinfects » ii cleans in one operation. Qxonia Active can bis used to cfeinfed flows,
walls and other hard nonpwws surface* such astabtes, cfsaira, counteriops, bathroom fbdij«E, sinks.
shelves, racks, carts, refrigerators. waters, ite, iinoteum, vmf,, asphalt, porcelain, plastic {Stan as
polypropylene and polyethylene), stainless steel, or glass.
Areas oHJ**: in Hospitals, KM Oxonia Active to* Surgical and Obstetrical Swtes; Housekeeping
Services' Physical Therapy Department; Nunslng Services; Autopsy Facilities.. Also, use OKOIBB Active in
nursing twines, ottiw heaMh-care facilities, schools, colleges, veterinary clinks, arrimaS Ife sctence
laboratories, industrial facilities, distaiy anas, office building, recreafciwl facllWe*, retail and wholesale
establishments. No* for use on food preparation surfaces, medical deweas or medical equipment
surfaces.
COMei^TIOK OISIMFECTON AND CLE*MING
Oxonli Actht E ettectSvi againrf Staprt)*iDoes«s auws, Sa?mo)»,«a cftoteraesws, Psaaaomonas
aerugmoss. $almamtia e?ffem*fe, fetoewfts ^»f»towwm, flrateus w^arts, Ste^ocsecus pyo^ends
and Mstopfesma eapswfffft™* at 0.4% (4 oz p*r S gifHws of water) In Hand water <500 ppm as CaCO3) ,
5% bload Bftfum and drivrt soap film residue on hard nonparous surfaces, For heavily soiled areas a
pfectearang step * required. Prapafe a dlslntecSng wd Cleaning aotution bv dityling 4 ounces Oxonia
Acliy* in 8 gallons of wator (0,4% vlv) Ap|% soluti« wish mop, dalh, sponge, brush, Ecrul**r, or cosree
spray device as by soaking » as to wel an wirfae** ihorougWy. AJtow to remain wet far 10 minutes, then
remove solution and entrapped soil with a dtein wet mop, doth, or wet WORM pickup. Prepare a fresh
daily or when it becomes sailed or dtoted,
*Nol tested in the presence oJ soap film residue.
TUBERCULOCIDA1-
Oxonta Active pasaas She ngW requirements as a lubercufecida at 0.4% (4 oz. per 8 gallons of water) in
the preseree of 5% blood serum, 500 ppm hard wtter and residual soap scum on nanporew surfece5 at
20 deg C. Remowe heavy soil or grow fiMh prior to disinfeciiim AMow surfaces to remain wet for 10
minutes, then remove gotten wish a clean wet mop, doth, or wet wcjum
VIRtJCIDAl
At 0.4% {4 or p«r 8 gallons of water) Oxonii A««»* is «fl»c»itfe against Influenza Bffaiwani2/S2,
i nfiuenza A(H3N2) and Influenzi A < H1 N1 } when used at 20 deg C with a. 1 0 minute contact time in the
presence o! 500 pprn hard water and organic soi. Apply BS directed under disinfection.
DISINFECTING PHARMACEUTICAL AND COSMETIC SURFACES
5zonb Activ* is recommerKJed for use en hard, non-porous, environmental stirfeea* such as flocrs,
walls and processing equipmort in pharmsoeuttcal ami cosmetic processing faciiftes
This product i* effective against Sfc^phytococeus aursus, Satoonela c/wteratsura, aid PsewJomonas
aervginasaatQAX (4 oz in § gallons water) in IWldWBSer (SCO ppm as CflCQa), 5%bloOO»rom and
dried soap film residue. Fct h-savlly sotted areas a preeteanirig step Is required. Rinse all surfaces
th'Oroughly wftrnhedteinfeetiag solution ami maintains contact tine of at least 10 minuws. Product
contact surfaces must 'be rinsed with fterite water,
ACCEPTED
*ah COMMENT*.
Ne,
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-39
-------
FIFRA Inspection Manual, July 2002
xcna Active la td«fe fa as
ni^MFEgrjmLQLPOULTRY PREMISES.. TRUCKg., CQQES-ANPgAIES «^41^«
1 S'emwe all poudry and feeds from F«miee«, Mdo. owe snd crates. «*wd «te
2 Remcwfl al fttter and droppings from floor*, wato *r«l wrfaow of faciMies oceup«d of traversed by/^
pcsulu>.
3. Empty all troughs, racks and other feeding and watering apofeiees.
4 Thoroughly clean all surfaces with a detergent and rt«e wrth water.
5^ Saturate surfaces wilh a 0.4% (A oz. j»r 8 gaBon* of water) solution of Qxonla Active for a j»r»«i of
10 minutes. . . „,
6. Vertate SuMBis^. «»P* a"d rther closed spaces- Do no! house pouiiry or em|*5y eqyipmenl until
treatment has been absorbed, sal or drted,
7. ThorouBhly scrub treated feed racks, trough*, automatic feeders, fountains anc) waterers w»r» *
Detergent and rinsn with potabte wate beten reuse, , . ,
See yew Ecolab or Aiffcem Represeruwlwe ftsr specffle reoommwdatons for all cleaning and raising
POULTRY HATCHEBY DlSIMFECTlOM
Ctesn out any remaining Bggs and chteto, Rerrwva yo«« «ois, such as fitter, dawn, shell fragments or
other hatching retotad debris, Empty all racks and other e^ip went Thoroughly wash all surfaces,
including floors walis ooweyors, trays and water systems with a fecofninendted detergent. Rins«
thofwghly with water, Apply a 0.4% (4 oz. per 8 gatora o* water ) solution of Oitonta Active wSM a mop.
cloth, brush or osarss spray Wa all surfaces and allow to remain WEI for 10 rrwutes. Ventilate bur-dings
and cither closed space* Allow to dry bftlflf* rwintroducang «ggi.
DISINFJCTIQN AMn nPOOQ-Rl^lMG OF ANIMAI HOUSING, f-ACIimES I&ARHS, KENNED
Ml 5Tr*HI~ ^^
R«™?« 8«mal8 and feed from facililies. Ramon litter, waste matte rand gross soils Emply ell troughs,
rack and other feeding and waSerins equipment Wash surfaces witr, a recommended siknine d*tef&eni,
by traruat foam, or spray applicatwn Rinss wtth w«er. Apply a 0 *% (4 oz. per 8 gallons of water)
solul»sfl of Oxonia Active with a mop. cldtti, fenish or coarse spray. Wei all surfaces and aliow to remain
wet for 1 0 minutes. Veniilate buildings and olheir dosed spares Allow » air dry b«fef« ranlroducrng
awmals. Effective against AsptiyHos
yiRUClDAL ACTIVITY - Poutfy and Lwestodt Pathogens
Oxonia Actiw is usaful as a disinfectant againsl viruses pathogenic to poultry thai includ§ Influenza A
(H10N?J Newcastle Disease vrus, Infectious bronchitis vims, R*wirus {C0t), as well m bovine and oth&'
iwesiDdt'pattiagsns, Shat include Inleeltous txwfcw rtiiretftcfteltm {IBR), Parainfluftnza 3 Virus, and Ins
toff, t moi/lfi (3iS*8SC virus (
BACTglOSTATIC
At 0"04% {1 oz. per ZO gallons of water} Oxonta Active is effective at Inhtoitng *e growth of Dactena
when ui8d In the presence of 5QG ppm hart water and organic soil.
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-40
-------
FIFRA Inspection Manual, July 2002
ia Adi rt .ate
P*ge § Apr ! 6 , 2C0 1
HATCH1NS-ESGS
Prepa-e a solution, or Oitonia Actws by diluting 2 ez product with 5 geitans ol water, As «g§s are
or prkjr to setting, apply saluUon as a ooame siway &o as to tightly wet all shell surfaces.
1 1
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-41
-------
FIFRA Inspection Manual, July 2002
ie Active label ^S^e I Ap-nti,
STERILISATION OF MANUFACTURING, FILLING, AND PACKAGING EQUIPMENT IN ASEPTIC
PROCESSES
Prior to use o* thi* product, remove gross sail partietos from processing surfaces, men wash witn a
recommended deiergwl solution, foUowftd by a firoreygn potable wafer rinsa. Prepare a sSenfeing
solution by diluting 6.4 ounces Oxonta Active concentrate per each gallon of w»er (SO mUHtw) (5.0%
v/v}. Circulate, coarse spray, or ttood tne »terifei>B sohflion IhrougJi the system. AS surfaces should few
exposed 80 She sterilizing solution fa a minimum ensure time based on the product stfuticr,
temperature. The fallowing time and temperature nfWkwships are required:
Oxooia Active
poncanCfaltoD _ JTttfnoerBtore __ -- , —
5% 68'F (201C) 6 hcyrs
6% 122T(6(rC}
6% 1
Rinse surtaces completely wifc a sSerUe water rinse. Fc< r»4-cQnia=t surfaces, Wkw with a saralfelng
solution of Oxonla Active. Allow surfsees to drain Biwough ly prior to any tecfi producl conact.
NOTE: This product tn its use $otul»ns is eofnpattble with stainless steal and a'jminum surfaces. If
product is Intended to bs used m any olrwr syrtaee, it m nseomrr
-------
FIFRA Inspection Manual, July 2002
*** SECTION 18 AMENDMENT ***
Carl Bausch, Deputy Director
Environmental Services
Policy and Program Development
Animal and Plant Health Inspection Service
(APHIS)
United States Department of Agriculture
4700 River Road, Unit 152
Riverdale, MD 20737-1237
Attn: Kelly White
Fax: 301-734-5992
Email: kelly.e.white@aphis.usda.gov
File Symbol: 99-DA-07
Chemical: sodium hypochlorite (bleach)
The Environmental Protection Agency hereby amends the quarantine exemption referred
to above, originally issued to the United States Department of Agriculture (USDA), Animal and
Plant Health Inspection Service (APHIS), pursuant to section 18 of the Federal Insecticide,
Fungicide and Rodenticide Act, as amended, on April 9, 1999. The following provision of the
April 9, 1999 authorization is hereby amended as follows:
Treatments may be made by USD A/APHIS personnel, any State Department of
Agriculture personnel, farmers, or any other individuals who need to use this disinfectant
on surfaces potentially exposed to certain animal diseases, including Foot and Mouth
Disease.
The effect of this amendment is to remove the language that restricts the use of sodium
hypochlorite (bleach) to USD A/APHIS personnel. All other provisions of the original April 9,
1999 document and March 15, 2001 amendment remain in effect.
Robert A. Forrest, Chief
Minor Use, Inerts, & Emergency Response Branch
Registration Division/OPP
Date:
cc:
REGION 1
CONTACT: Robert Koethe
FAX: 617-918-1505
REGION 2
CONTACT: Adrian Enache
FAX: 732-321-6788
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-43
-------
FIFRA Inspection Manual, July 2002
REGION 3
CONTACT: Harry Daw
Fatima ElAbdaoui
FAX: 215-814-3113
REGION 4
CONTACT: Lora Lee Schroeder
FAX: 404-562-8973
REGION 5
CONTACT: Lavarre Uhlken
FAX: 312-353-4788
REGION 6
CONTACT: Johnie Dowell
FAX: 214-665-7263
REGION 7
CONTACT: Luetta Flournoy
FAX: 913-551-7165 (-7065, alt)
REGION 8
CONTACT: Debbie Kovacs
FAX: 303-312-6044 (-6363, alt)
REGION 9
CONTACT: GlendaDugan
FAX: 415-744-1073
REGION 10
CONTACT: Chad Schulze
FAX: 206-553-1775
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-44
-------
FIFRA Inspection Manual, July 2002
v~
> UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
^ WASHINGTON, D.C. 2O46O
< OFFICE OF
0 PREVENTION, PESTICIDES, AND
TOXIC SUBSTANCES
******** signed 8/31/2001 *****
Carl Bausch
Deputy Director, Environmental Services
Policy and Program Development
Animal and Plant Health Inspection Service (APHIS)
United States Department of Agriculture
4700 River Road
Riverdale, MD 20737-1237
Attn: Kelly White
Kelly.E.White@aphis.usda.gov
Fax: (301) 734-5992
File Symbol: Ol-DA-05
Expires: Three years from the date of issuance
The Environmental Protection Agency (EPA) hereby grants a quarantine
exemption under the provisions of section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act, as amended, to the United States Department of Agriculture (USD A), Animal
and Plant Health Inspection Service (APHIS), for the use of acetic acid to control foot and mouth
disease around the country. This quarantine exemption is subject to the conditions in your
application as well as the following:
1. The USD A/APHIS is responsible for ensuring that all provisions of this quarantine exemption
are met. It is also responsible for providing information in accordance with 40 CFR 166.32(b).
This information must be submitted to EPA headquarters within 6 months of the above
expiration date.
2. Treatments consisting of a 4-5% solution of acetic acid (vinegar) and water may be made to
farm equipment and slaughter machinery, military equipment, footwear and clothing, agricultural
facilities, quarantine facilities, shipping conveyance, aircraft, and any other non-food items or
surfaces potentially contaminated with foot and mouth disease virus.
3. Treatments may be carried out nationally on an as-needed basis as part of a prevention or
eradication program for the foot and mouth disease virus.
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-45
-------
FIFRA Inspection Manual, July 2002
4. USD A/APHIS shall ensure that mixers will be advised to wear protective eye wear when
diluting acetic acid with water.
5. No treatments are permitted under this authorization to food or feed items.
6. EPA headquarters and the appropriate regional offices shall be informed of any adverse
effects resulting from use under this quarantine exemption. An interim report summarizing, to
the extent available, the results of this program must be submitted annually and a final report
summarizing the results of this program must be submitted six months after the expiration date
of this exemption.
/s/
Anne E. Lindsay,
Acting Deputy Director for Pesticide Programs,
Office of Pesticide Programs
Date:
cc:
REGION 1
CONTACT:
PHONE:
FAX:
REGION 2
CONTACT:
PHONE:
FAX:
REGION 3
CONTACT:
PHONE:
FAX:
REGION 4
CONTACT:
PHONE:
FAX:
REGION 5
CONTACT:
PHONE:
FAX:
REGION 6
CONTACT:
FAX:
8/31/2001
Robert Koethe
617-918-1535
617-918-1505
Adrian Enache
732-321-6769
732-321-6788
Harry Daw
215-814-2041
215-814-3113
Lora Lee Schroeder
404-562-9015
404-562-8973
Lavarre Uhlken
312-886-6016
312-353-4788
Johnie Dowell
214-665-7263
REGION 7
CONTACT:
PHONE:
FAX:
REGION 8
CONTACT:
PHONE:
FAX:
REGION 9
CONTACT:
PHONE:
FAX:
Allen Demore
415-947-4212
Karen Heisler
Marcy Katzin
REGION 10
CONTACT:
PHONE:
FAX:
Luetta Flournoy
913-551-7653
913-551-7165 (-7065, alt)
Debbie Kovacs
303-312-6020
303-312-6044 (-6363, alt)
Glenda Dugan
415-972-3099
415-947-3562
Chad Schulze
206-553-1747
206-553-1775
Chapter Twelve • Use Inspections & Follow-up Enforcement • 12-46
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Chapter Thirteen
RESIDUE & ENVIRONMENTAL SAMPLES
Table of Contents
Page
INTRODUCTION 13-1
SAMPLING PLAN 13-2
Review Evidence 13-3
Obtain Technical Data From Various Sources 13-3
Pesticide(s) 13-3
Weather Data 13-4
Sample Selection 13-4
Laboratory Reporting of Sample Types 13-5
Sampling Equipment 13-5
Sampling Equipment List 13-6
Incident Site 13-6
GENERAL SAMPLING GUIDES 13-7
SAMPLE COLLECTION & PRESERVATION 13-8
Sample Containers (Guidelines) 13-8
Sample Collection Record (Guidelines) 13-9
Foliage 13-9
Discrete Foliage Sampling 13-10
Grid Pattern Foliage Sampling 13-11
Composite Foliage Sampling 13-13
Crop Damage Residue Incidents 13-13
Human Exposure Incidents 13-14
Sample Collection 13-14
Property Loss Incidents 13-15
Agricultural Pesticide Misuse 13-17
Structural Pesticide Misuse 13-18
Discrete Soil Sampling (Known Depth) 13-18
Soil Sampling In Furrowed Fields 13-19
Discrete Soil Sampling (Known Depth, Furrowed Field) 13-19
Single Rows 13-19
Double Rows 13-29
Grid Pattern Soil Sampling 13-20
Gradient Soil Sampling 13-20
Composite Soil Sampling 13-21
Discrete Sediment Sampling 13-21
Water 13-21
Discrete Surface Water Sampling 13-22
Air 13-22
Air Sampling Indoors 13-23
Air Sampling Outdoors 13-23
Pesticide Formulations (Technical Grade) 13-23
Tank Mix 13-24
Animals, Fish, Honeybee Sampling 13-25
Surface (Wipe) Sampling 13-26
Discrete Surface Sampling 13-26
Grid Pattern Surface Sampling 13-27
Gradient Surface Sampling 13-28
Clothing 13-28
SAMPLE STORAGE, PRESERVATION, AND SHIPPING 13-28
Storage and Preservation 13-29
Shipping Procedures 13-32
Chapter Thirteen • Residue & Environmental Samples • 13-i
-------
Hazardous Materials Shipments - UPS & FEDEX
Procedure 13-33
Investigator's Shipment Procedures 13-34
UPS Shipments 13-34
FedEx Shipments 13-37
Exhibit 13-1: FedEx Dangerous Goods Airbill 13-42
Chapter Thirteen • Residue & Environmental Samples • 13-ii
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CHAPTER THIRTEEN
RESIDUE AND
ENVIRONMENTAL
SAMPLES
INTRODUCTION
This chapter was developed to aid field personnel in the collection
of samples during pesticide incident investigations. Sometimes
sampling is done to establish hazardous areas such as accidental
spills, or to show that a pesticide was applied to a site not on the
label, or to show that, during application, a pesticide reached a
nontarget site prohibited by the label. Physical evidence is often
used to support a case involving alleged violations of pesticide laws.
The investigator must collect and submit samples of physical
evidence using methods that ensure the integrity of the evidence.
This will include information gathering, setting of sample goals, and
formulation of a sampling plan. Investigators should use this
section to provide direction in their sampling procedures and as a
reference in unfamiliar situations.
In many investigations the decision to collect samples must be
made immediately. Suspected human, animal, crop, or
environmental contamination can require quick action to determine
exposure or to prevent contaminated commodities from entering
the food chain. Pesticides that degrade quickly will require sampling
soon after their application to detect their presence. At some point
in the information gathering process, the investigator may realize
that immediate sampling is essential if the resulting analysis is to be
meaningful to the investigation. When in doubt, it is preferable to
take as many samples as could be needed and to select those which
are appropriate for analysis at a later time.
There are certain responsibilities the investigator must consider
during the investigation. Samples are an important aspect of an
enforcement action, but are only part of the overall information
gathering process. Samples cannot take the place of good
investigative procedures. The investigator must determine the goal
of the sampling and the appropriate sampling methods which
correspond to the goal. The nature of the incident will largely
Chapter Thirteen • Residue & Environmental Samples • 13-1
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FIFRA Inspection Manual, February 2002
define the investigator's goals and the sampling goals will direct the
way samples are taken. The investigator's goal is to collect the
appropriate type of samples to support an investigation of alleged
violations. In some investigations, sampling or sample analysis may
not be justified if enough time has elapsed to allow degradation of
suspected materials.
The investigator must gather as much background information as
possible. Cropping patterns, a history of pesticide use, technical
data on the pesticide formulation(s), application methods, and
weather conditions at the time of the incident are some of the
factors to be considered in determining sampling procedures. The
investigator must be aware of his/her laboratory's capabilities.
Some pesticides may require special sampling techniques or
handling procedures to ensure accurate analysis. For example,
collection of specific plant parts may be required with certain
formulations. Proper storage and transportation of samples is
critical and can affect the analysis results. It is important to
coordinate sampling activities with the laboratory and follow their
procedures to ensure the integrity of the sample is maintained.
Once background information has been assembled, a sampling plan
must be formulated. The plan must account for sampling
equipment, sampling procedures, amount and location of each
sample, safety precautions, quality assurance requirements, storage,
and method of transportation. At the incident site, the investigator
must conduct a preliminary survey of the area. This will help locate
landmarks, determine the objective of sampling, and facilitate
questioning of witnesses. A sketch or diagram of the immediate
area with landmarks, location of witnesses, measurements, points
of compass, and location of samples is mandatory for all thorough
investigations. Photographs can be helpful in documenting crop
maturity and surrounding landmarks (see Chapter One -
Documentary Support). Field notes must be taken with enough
detail to prepare a complete written report later. Information from
parties involved and witnesses is more accurate if gathered soon
after the incident. Supportive evidence (i.e., labeling, use reports,
etc.) is important where available. Maintain the Chain of Custody
with all physical evidence. Finally, draw all the elements of the
investigation together to prepare the investigative report.
SAMPLING PLAN
If the goals of the investigation require sampling, then a sampling
plan must be developed. For the more experienced investigators,
this thought process is initiated as soon as they are informed of the
incident and continues until samples are collected. The sampling
plan can be a thought process or a "formal" written outline. The
sampling plan outline is intended to be used as a reference and
training guide for new or less experienced investigators, but should
be reviewed periodically to refresh the memories of all
investigators.
Chapter Thirteen • Residue & Environmental Samples • 13-2
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FIFRA Inspection Manual, February 2002
Prior to sampling, consider distances and physical surroundings at
the incident site. Review notes, statements, permits, use reports,
and technical data on the alleged pesticides used to develop a
sampling plan. Because of time constraints and priorities, it will
probably not be possible to address all the items listed. It is
imperative, however, to establish the sampling goals before
collecting samples.
Review Evidence
The first step in developing a sampling plan is to review the
evidence gathered during the initial phases of the investigation.
Statements and interviews are an integral part of the investigation.
They will assist in determining the type of incident, validity of the
complaint, priority of the case, the pesticides used, the method of
application, approximate distances between treatment site(s) and
incident site, weather conditions, date and time of application(s),
application pattern, illness symptoms, crop damage patterns, etc.
Obtain Technical Data From Various Sources
Pesf/'c/'ofefs)
Technical data will assist in determining sample types, methods and
location, a time frame in which to collect samples, and if there
should be any special handling or sample preparation procedures.
Refer to the Farm Chemicals Handbook, Crop Protection Chemicals
Reference, Pesticide Product Description (section 18, "Toxicology") or
contact the supervisor to assist in gathering this information.
> Chemical properties
• Formulation
• Half-life
Metabolites
> Physiological and biochemical behavior
• Foliar absorption characteristics
• Translocation action
• Behavior in or on soils
* Absorption and leaching characteristics
• Microbial breakdown
• Loss from photodecomposition and volatilization
• Hydrolysis
*• Toxicological properties
• Toxicity to humans/wildlife/fish
• Acute/chronic toxicity
• Poisoning symptoms
*• The laboratory capabilities
Chapter Thirteen • Residue & Environmental Samples • 13-3
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FIFRA Inspection Manual, February 2002
• Method of analysis
• Analytical sensitivity
• Availability of method and/or reference standard(s)
Weather Data
Weather data (at time and place of incident occurrence), if available,
will help in determining drift patterns, volatilization rates, off-target
movement of pesticides, etc. This information can be obtained
from the National Weather Service, local agencies, airports, etc.
* Wind speed and direction
* Rainfall
* Temperature
*• Inversion
*• Humidity
Sample Selection
Selecting the sample type(s) will depend on the type of incident that
allegedly occurred. For example, if the incident involved:
*• Drift of a pesticide on people, the sample type could include
total foliage, (i.e., total residue on foliage) in a gradient
pattern and surface clothing.
*• Drift of pesticide on people harvesting a commodity, the
sample types may include total foliage in gradient pattern,
total commodity, dislodgeable foliage and surface clothing.
* Misuse of a pesticide in a structure (e.g., crawlspace), the
sample types may include total soil and surface (wipe).
* Crop damages from run-off containing a pesticide sample
types may include total soil or total foliage in a gradient
pattern, total commodity and total plant.
*• Fumigation of railcars, ships, containers or homes.
In most drift incidents, the pesticide application in question has
been performed a short time before. If the available plants have a
heavy canopy, thus allowing limited soil exposure to direct spray,
vegetation should be chosen as the sample of choice. If vegetation
at the incident site is limited, excessive time has passed since the
application, there is new plant growth or heavy rains could have
reduced the concentration, soil should be the sample of choice.
The purpose of sampling is to collect evidence to determine if a
violation occurred. An investigator will have to use his/her best
judgment in selecting the appropriate sample types based on the
information gathered.
Whatever sample type is used, samples must be representative of
the media being sampled if it is to provide the basis on which to
determine that a violation exists. Therefore, a "statistical" approach
Chapter Thirteen • Residue & Environmental Samples • 13-4
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FIFRA Inspection Manual, February 2002
must be considered. This requires the selection of sampling points
that will produce a representative sample (i.e., non-point grid
pattern). In addition, keep in mind the statistical considerations that
affect representative sampling, such as variability in sample
collection methods; frequency of samples taken over a period of
time; and number of samples collected relative to size of site.
Laboratory Reporting of Sample Types
Sample results, as reported by the laboratory, normally are reported
in terms of:
* Total (weight of pesticide/total weight of sample, ppm)
• Foliage
• Commodity
• Plant (whole or portion)
• Soil (surface or depth)
• Animal/fish/honeybees
Water
Feed
• Tank mix
• Pesticide information (reported in percent)
*• Dislodgeable (weight of pesticide/surface area, • g/cm2)
• Foliage
* Surface (weight of pesticide/sample • g or wt/area, • g/cm2)
• Clothing
• Surface area
- Windows
- Rugs
- Floors
- Wans
- Automobiles
*• Volume (weight of pesticide/volume, mg/m3, • g/1)
Air
• Water
Sampling Equipment
Unless disposable sampling equipment is used, the sampling
equipment must be cleaned between each sample, using distilled
water. To decontaminate the equipment, wash and double rinse
with distilled water, then rinse with propyl or isopropyl alcohol
(Note: Sulfonyl urea products require a 5% solution of chlorine for
1 minute contact time for decontamination). Also be sure to wash
Chapter Thirteen • Residue & Environmental Samples • 13-5
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FIFRA Inspection Manual, February 2002
your hands and change disposable gloves to prevent cross-
contamination of samples. The equipment must be stored in the
office or car, in a clean (i.e., uncontaminated) designated location.
For smaller equipment, an enclosed, airtight container is
recommended. The larger equipment can be wrapped in an
uncontaminated cloth or cleaned and decontaminated prior to
sampling.
Sampling Equipment List
* Sample Collection Record Forms.
* Paper, plastic bags, jars (various sizes) and aluminum foil.
*• Personal safety equipment and clothing as required for
sample collection (coveralls, respirator, goggles, hard hat,
disposable & rubber gloves, boots, rain suit, waders, etc.).
* Labels, tape, stapler, evidence tags, official seals or evidence
tape.
*• Shovel, hand spade, knife, pruning shears, trowel, spatula,
or leaf punch.
*• Hexane, isopropyl alcohol, distilled water, and paper towels.
* Sterile wipes and precut templates. Measuring tapes, stakes,
camera, film and accessories.
* Ice chests (coolers, styrofoam), "Blue-Ice," wet ice, dry ice
(Caution: do not handle dry ice with bare hands or allow
samples to directly contact the dry ice).
*• Permanent markers, pencil, pen, note pad, record book.
* County or city map, aerial maps, topographical maps.
* Disposable core tubes, siphon tubes.
Incident Site
Actual surveillance of the incident site, along with the evidence
collected, will help provide a complete picture of what occurred. It
will assist in determining whether possible violations occurred. It
should be the basis for drawing a diagram of the incident site with
specific landmarks to assist in the investigation. A Global
Positioning System (GPS) device may be used to pin-point exact
locations. Note: when surveying the incident site, do not
contaminate yourself by walking through the treated area.
Make the following observations, as appropriate:
* Distances from treatment site(s) (Note: the inspector should
indicate if the diagram is not to scale, or if it is to scale,
indicate the scale).
* Odors in structures
* Crop type, maturity, acreage
*• Physical surroundings
Chapter Thirteen • Residue & Environmental Samples • 13-6
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FIFRA Inspection Manual, February 2002
• Telephone poles (Note the ID # on the pole) adjacent
crops
• Sampling medium (foliage, surface areas, etc.)
• Landmarks
• Waterways
• Location of workers
• Vehicles
• Trees
*• Physical evidence
• Crop/plant damage
• Tire tracks
• Spotting on leaves, walls, floors, etc.
• Pesticide containers in storage
*• Incident Site Diagram
After reviewing the evidence collected, (e.g. statements, interview
notes, and records); surveying the incident site; researching and
obtaining technical data on the pesticides allegedly used; and
selecting the sample types; it is helpful to draw a diagram of the
incident site as near to scale as possible with North at the top.
Include the location of the incident site and treatment site (if
different), landmarks, the crop's stage of growth, acreage, adjacent
crops and sites, room dimensions, the location of witnesses,
distances between the points, wind direction and speed. As samples
are collected, identify their location (s) and distances on the
diagram. The diagram must be large enough to include all of the
details and be legible. Accurately identify locations of samples
through triangulation (GPS can be used to accurately establish
exact locations).
GENERAL SAMPLING GUIDES
Applying the following guidelines to individual cases will reduce
haphazard sampling. Investigators must:
* Adapt a sampling plan to the requirements of the individual
investigation.
*• Have the necessary sampling tools and sample containers
and personal protective equipment.
*• Always wear protective clothing and safety equipment as
required by the pesticide label when entering treated
fields/areas or handling samples.
Chapter Thirteen • Residue & Environmental Samples • 13-7
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FIFRA Inspection Manual, February 2002
*• During all phases of the investigation, be careful not to
contaminate yourself or cross-contaminate the samples.
Always wear dean disposable gloves, protective clothing,
and safety equipment as required by the pesticide label,
regulations, and policy when entering fields/areas or
handling samples. It may be necessary to change gloves and
other protective clothing between collecting each sample in
order to help ensure that cross-contamination does not take
place.
* Concentrate sampling in the area that best manifests the
symptoms associated with the problem. Different types of
sample analyses (such as soil vs. grass) are difficult to
compare. Similar materials should be used for comparison
samples, such as in cases where treated and non-treated
areas are to be compared. Similar foliage types (grass-to-
grass) must be sampled when possible.
If the situation dictates, a composite, duplicate or split sample may
have to be taken to meet the sampling objectives.
*• Composite Sample: Combination of two or more sub-
samples to produce a homogeneous sample.
*• Duplicate Sample: Two or more samples collected from the
same area subject to comparable conditions.
*• Split Sample: Division of a sample into two equal and
identical portions. This is usually done at the laboratory.
Composite sample analyses must only be conducted when the area,
crop, or material is suspected to be uniformly contaminated, to
identify suspected chemicals, or to determine if a broad area is
contaminated.
Draw a diagram of the incident site. The diagram must include such
things as the sample locations, landmarks, adjacent crops and sites,
room dimensions, the location of witnesses, distances between
points, etc.
SAMPLE COLLECTION & PRESERVATION
Physical pesticide sampling may include concentrated pesticide
formulations, diluted pesticide solutions, and any substance or
material suspected to be contaminated (environmental residue
samples). The following guidelines must be followed:
Sample Containers (Guidelines)
All samples collected in glass (except one liter amber water
samples) must be identified with the sample number, date, and
inspector's initials and placed in large 12" x 30", inverted, heavy
polyethylene bags. All samples collected in large 12" x 30" heavy
polyethylene bags, must be sealed as follows:
Chapter Thirteen • Residue & Environmental Samples • 13-8
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FIFRA Inspection Manual, February 2002
(Note: evidence bags may also be used; however, they must be
properly identified and sealed as appropriate).
*• Identify and officially seal samples immediately. Each
container must be further identified with the sample number
and inspector's initials. Place the sample(s) in the inverted
polyethylene bag, and:
• Twist the top of the bag, and tie a knot in the inverted bag.
• Fold the top of the bag down over the knot and twist the
bag around the knot.
• Apply several wraps of tape (masking, mono filament, etc.)
below the knot.
• Apply the EPA Official Sample Seal (EPA Form 7500-2)
(or if State/tribal inspection, the equivalent State Tribal
Sample Seal) around the tape. The official sample seal
shall be identified with the sample number, date, city, State
of collection, and the inspector's name and signature.
For one Liter Amber Bottles:
* Tape (masking, mon-filament, duct or equivalent type)
individual dry bottles around the cap and deep into the
neck.
* Place investigator's initials across the end of the tape.
*• Follow all other procedures above for identifying, logging,
and sealing the sample.
Sample Collection Record (Guidelines)
A Sample Collection Record must be filled out in indelible ink and
accompany the samples to the laboratory. The record must be
placed in a separate sealed plastic bag to prevent moisture
absorption.
* Identify sample material as accurately as possible.
* If possible, identify specific pesticides or classes (e.g.,
organophosphates, phenoxys, etc.) suspected to have caused
the problem. Also include the phrase "WARNING-
PESTICIDES" on the Sample Collection Record to warn
laboratory personnel.
*• Identifying numbers on sample containers must be copied
exactly as on the Sample Collection Record to identify the
sample for the lab.
Foliage
Pesticide drift or other misapplications of pesticides are often
documented by sampling and analyzing foliage or whole plants for
residues. The sampling techniques described below are applicable
for most agricultural crops as well as nonagricultural vegetation
Chapter Thirteen • Residue & Environmental Samples • 13-9
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FIFRA Inspection Manual, February 2002
(non-crop) where suspected drift or overspray (swath displacement)
is to be documented.
Discrete Foliage Sampling
Samples may be collected in a gradient or grid pattern.
Collect foliage from a specific area (i.e., reference point) in the field.
The purpose of collecting the sample from a specific area is to
identify a residue delineation between the sample areas, and to
maintain sampling uniformity. It is important to identify the
location of the sample site within the field because the sample and
incident site diagram may be used as evidence in an administrative
or judicial action. The size of the sample area will vary with the type
of location. For example:
*• At all sites, a control sample must be collected from an area
of similar vegetation type as of that within the affected areas.
It can be on the complainant's property, some distance away
from the area treated and where drift/overspray is
suspected. This sample is taken to verify that good sampling
techniques were used and the sample was not
contaminated. It is absolutely critical that the control sample
be taken from an area known to be free of any contamination
from the pesticides in question. A contaminated control
sample will destroy the usefulness of other samples as
evidence. Take only one substrate in each sample, i.e. soil
only or vegetation only. They must not be mixed.
* Subsequent samples must be collected in a sequential order
from the least anticipated residue concentration to the
greatest anticipated concentration, (i.e., control, suspected
drift area, then target area). This will help reduce the
potential for cross contamination of samples. Do not hesitate
to take enough samples to show that drift occurred and to
what extent by establishing boundaries of contamination.
Unnecessary samples can always be discarded later by the
lab. It is rarely possible to collect additional samples at a
later time.
*• Field crops and non-crop areas (weeds, fallow fields, etc.):
the size of the sample site must be approximately a 25-foot
square (or 625 square feet).
*• Orchards and ornamentals: sample from approximately four
mature trees/vines (rectangle or square area). The area will
vary depending on the size of the incident site, the size of the
plants and foliage within the site, and the number of samples
intended to be collected.
*• Smaller plants (seedlings) with minimal foliage on a plant or
tree (bud leaf stage), or multiple analyses: a larger area must
be used.
*• Remember, measure the sample area and record it in the
investigative notes.
Chapter Thirteen • Residue & Environmental Samples • 13-10
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FIFRA Inspection Manual, February 2002
* Try to collect foliage of similar type (e.g., grasses or
broadleaves only), if possible. It will make it easier to
extrapolate the data. If similar type foliage is not available
throughout the sampling area, collect different types of
foliage.
* Select foliage from all sides of the plant/tree unless drift is
suspected. In this case, collect the foliage from the side of the
plants allegedly exposed to the drift. For most situations,
collect the foliage from the outer leaves of the plant/tree. It
may be necessary to uproot the whole plant if systemic
pesticide absorption is suspected. Do not select foliage that is
in contact with soil. Only collect leaves; do not include twigs
or branches. Remember, new growth not subject to chemical
application may affect the results of an analysis.
* Collect enough foliage from the specific sample area to
permit proper analysis or screening. If composite, duplicate,
or split samples are requested, increase the sample size
accordingly. Contact the laboratory if in doubt regarding
sample size.
* Vegetation samples, etc. must be wrapped in aluminum foil
(pre-rinsed with hexane) and placed in large 12" x 30",
inverted, heavy polyethylene bags; alternately, vegetation
samples can be collected in glass jars.
* Use proper sample preparation and sample collection
recording.
*• Indicate maturity of sample foliage, if applicable.
* Samples must be chilled, refrigerated or frozen as soon as
possible. An ice chest with regular or "Blue-Ice" can be
carried into the field for this purpose. If samples are stored
frozen, attempt to ship them on dry ice preventing the plant
tissue from decomposing during shipment.
* Samples must be shipped to the laboratory as soon as
possible after they are collected.
Grid Pattern Foliage Sampling
Grid pattern samples are taken to establish uniform or partial
contamination of the incident site. The sampling pattern should
represent the entire field or site. Each point on the grid represents a
sample and should be kept separate from the others.
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Figure 13-1: Grid Pattern Examples
If pesticide drift is suspected from an adjacent field or the source
of contamination is unknown, a grid pattern may be used in place
of the gradient pattern. If misapplication to part of a field is
suspected (tank cross-contamination or partial application), but the
treated area is unknown, this type of sampling pattern should be
used to isolate the area (a GPS device may be beneficial in locating
precise locations).
Collect samples in a grid pattern following the procedures indicated
for a discrete foliage sample. Each sample represents one point on
the grid for that field or site, therefore, do not composite them.
After a control sample is taken, the sampling grid pattern in the
incident site must start approximately 100 feet from the edge of the
field, depending on the field size. As a rule of thumb, the distance
from the edges must represent approximately 10 percent of the
width and length of the field or site. For example, a site 1,000 feet
wide and 2,000 feet long (approximately 46 acres) has a starting
point 100 feet in from the length and 200 feet in from the width.
Each sample must be in line with, and at an equal distance apart
from, one another in the grid pattern. Record the sample locations
in the investigative notes and diagram(s).
If using the grid pattern to establish drift, collect one additional
sample from each of the adjacent fields that are suspected of being
the source of contamination.
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Each foliage sample from a site must be of similar type and taken
from the same location on the plant/tree. Identify the location and
area from which each sample was taken on the diagram with
distances from landmarks, field borders, and between samples
clearly indicated.
Use proper sample preparation and Sample Collection Recording.
Gradient samples are taken to establish the severity and extent of a
drift incident. After the control sample, always sample from an area
of suspected lowest concentration in a direction towards the area of
highest concentration (treatment site) to prevent contamination of
samples. If more than one source of contamination is suspected,
collect gradient samples towards each suspected source or use the
grid pattern. Do not composite samples. Wear the required
protective clothing and use clean, uncontaminated gloves and tools
between each sample.
Samples must be collected from defined areas in the field or site
similar to the methods indicated in the procedures described
previously for a discrete foliage sample.
In most situations, collect a minimum of five foliage samples in a
gradient pattern at an equal distance apart. At minimum, one
control sample must always be from outside of the suspected
contaminated area and at minimum, one sample must be from the
suspected source area of contamination. The gradient pattern must
be in a straight line.
Foliage must be of similar type and taken from the same location
on the plant/tree for each sample. On the diagram, identify the
location and area from which each sample was taken including
distances from landmarks, field borders, and distances between
samples.
Refer to Discrete Foliage Sampling for sample size, sampling
sequence, containers, and sample preservation. Maintain the Chain
of Custody.
Use proper sample preparation and Sample Collection Recording.
Composite Foliage Sampling
Composite samples are taken to determine whether or not an area
is contaminated and to determine if other samples must be
analyzed. After taking a control sample, a composite sample is
made up of several sub-samples that are of equal volume or weight
and are combined to represent a field or site. Collect enough foliage
for each grid point sample to allow for the requested analyses.
Crop Damage Residue Incidents
After taking a control sample, samples must be taken in a line, at
approximately equal intervals, from non-suspected area to the
target treated area. (Top to bottom).
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Human Exposure Incidents
After taking a control sample, samples must be taken in a line, at
approximately equal intervals, from the least-suspected area (near
the children) to the target treated area. (Bottom to top).
Figure 13-2: Gradient Sampling Diagram -
Crop Damage Residue Incident
Sample Collection
* Wipe from vehicle
* Vegetation/soil samples in gradient pattern
* Clothing
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Figure 13-3: Gradient Sampling Diagram -
Human Exposure Incident
Property Loss Incidents
Sample Collection
* Vegetation/soil samples in gradient pattern
* Commodity, if harvesting
* Wipes from vehicle
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* Clothing
When there are multiple pesticide applied areas, the same gradient
pattern is used as previously described , but samples are obtained in
two directions toward the treated areas.
.Treatment
Site
Complaint
Treatment Site
Figure 13-4: Gradient Sampling Diagram -Property Loss Incident
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FIFRA Inspection Manual, February 2002
Treatment Site
Agricultural Pesticide Misuse
Sample Collection
»
\
Vegetation/soil samples in gradient pattern
Commodity, if harvesting
Wipes from vehicle
Clothing
\
Crew
Harvesting
+ , o
\
\
Figure 13-5 - Gradient Sampling Diagram - Agricultural Pesticide Misuse
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FIFRA Inspection Manual, February 2002
Structural Pesticide Misuse
NOTE: Labeling allows a 5 foot band around perimeter of house
and 2 to 3 foot up the foundation wall.
Lawn Area
Lawn
Area
-V
n
Dog
• 1
• 2
• 3
. 4
Patio
House
Lawn
Area
Figure 13-6: Gradient Sampling Diagram -
Structural Pesticide Misuse
Discrete Soil Sampling (Known Depth)
Soil samples at a known depth are collected when the pesticide is
suspected of being incorporated, band treated, shanked, or moved
below the soil surface (leaching). If the samples are not collected at
the proper depth, the sample results will be misleading. This type of
sampling may be collected in a grid pattern within a field or site.
After taking a control sample, select a specific sample location and
measure an area of approximately one-square foot. Record the
measured sample area in the investigative notes.
If it is suspected that chemical leaching has occurred at the sample
site, dig a sampling hole and collect soil from various depths (e.g.,
3-6 inches, 6-9 inches, etc.). After digging the hole, decontaminate
the sampling instrument and shear away the soil face at the depth
desired starting with the deepest sample. Decontaminate the
sampling instrument or use a clean jar and collect the sample.
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Repeat this procedure moving upward in the sample hole until all
samples are collected. If a soil probe is available, remove the soil to
the beginning depth to sample. Take several core samples to the
desired depth using the probe. NOTE: It is not recommended to
use the probe when a band or side-dress treatment was used. Since
it is difficult to determine where the band treatment is located the
probe technique could miss the pesticide and give misleading
results.
Samples must be recorded and handled the same as described
above
So/7 Sampling In Furrowed Fields
Single row beds: combine soil from the imaginary area outlined in
the figure below in a container and fill a 1 quart jar.
Double row beds: Center furrow to center bed.
Height
of bed
12-14"
below furrow
3-6'
Figure 13-7: Soil Sampling in Furrowed Fields
Discrete Soil Sampling (Known Depth,
Furrowed Field)
Chemicals may have been applied in bands or side-dressed in
furrowed fields. In order to sample from the appropriate area, a
shovel is needed to cut across sections perpendicular to the
direction of furrow at each sample site.
Single Rows
After taking a control sample, start at the center of the furrow and
sample across the bed to the center of the opposite furrow. Collect
soil from an area 3"-6" wide and 12"-14" deep as measured from
the top of the bed.
Double Rows
If the field is laid out in double row beds, sample from center of
furrow to center of bed at 3"-6" width and 12"-14" depth.
Mark the location of the sample area on the diagram indicating
distances from each sample, depth and width of sample, landmarks,
and field borders.
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Grid Pattern Soil Sampling
Grid pattern soil sampling is used to establish the pattern of
contamination of the incident site. The sampling pattern must
represent the entire field or site. Each point on the grid pattern
represents a sample and must be kept separate from the others.
There are several pesticides (e.g. DCPA and chlorothalonil) that are
long lasting in the environment and adhere to soil particles. Cultural
practices (i.e., disking) and wind can move these particles from
adjacent fields to a crop, creating a potential residue problem. The
grid pattern sampling results can be used to document the transport
of the soil particles. If misapplication to part of a field is suspected,
but the treated area is unknown, the grid sampling pattern must be
used to define the affected area.
Collect soil samples at the appropriate depth in a grid pattern
following the procedures indicated for a discrete soil sample
(surface, known depth, furrowed field). Each sample will represent
one point on the grid for that field or site. Do not composite these
samples.
After taking the control sample, the sampling grid pattern must
start approximately 100 feet from the edge of the field, depending
on the field size. As a rule of thumb, the closest sample distance
from the edges must represent 10 percent of the width and length
of the field or site. Each sample must be in line with, and at an
equal distance apart from, the other samples in the grid pattern.
Record the sample locations in the investigative notes.
If the field or site is suspected of being only partially contaminated
(i.e., three-quarters of the site was treated), collect samples from the
area of lowest concentration to the highest.
Gradient Soil Sampling
Gradient soil sampling is usually conducted to prove drift from a
treated area. If drift is suspected to have occurred to a field and the
pesticide can be detected in soil, then gradient sampling may be of
use. A gradient pattern may also be used to determine if a structural
or residential application was made according to label directions.
Samples must be collected from defined areas in the field or site
similar to the methods indicated in the procedures for a discrete
surface soil sample as described in Figure 13-7.
Collect surface soil samples in a gradient pattern at an equal
distance apart with at least one control sample (collect first) outside
the contaminated area and one or more samples from the suspected
source area of contamination.
Always sample from an area of suspected lowest concentration in a
direction towards the area of highest concentration (treatment site).
Collect gradient samples towards each suspected source if more
than one source of contamination is suspected.
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Composite Soil Sampling
Composite soil samples are taken to determine if an area is
contaminated or to determine if other samples must be analyzed.
The composite sample is made up of several sub-samples that are
combined to represent a field or site.
If composite samples are desired, combine soil from the grid point
samples to make a composite sample. Collect enough soil for each
grid point sample to allow for the requested analyses.
Discrete Sediment Sampling
If equipment is not available to collect a sediment sample or
assistance is needed, contact the supervisor. The supervisor will
make the arrangements to have the appropriate agency assist or
collect the samples.
Pesticide residues can accumulate in the bottom sediment of lakes
and streams. It may be necessary to conduct sediment sampling to
document the pesticide source. There are commercially available
devices for sediment sampling, but these devices often require
extensive cleaning between sampling to prevent cross-
contamination. Directly scooping sediment into a glass jar is
recommended for shallow sampling situations.
Sediment contents can be flushed or diluted as the jar is lowered or
retrieved through water exceeding a few inches in depth. Therefore,
a disposable core tube is recommended for unconsolidated
sediment and use of a commercial sediment-collection device is
recommended for firm bottom deposits.
Carefully lower disposable core tube or other sampling device
through water into sediment (minimize disturbing the sediment).
Retrieve approximately one quart of sediment.
Transfer sediment directly into a clean glass sample jar or a clean
pan. Remove rocks, leaves, and other debris from sediment before
transferring to the wide mouth glass jar. Seal with Teflon or foil-
lined lid.
Mark the location of the sample area on the diagram indicating
distances from each sample, landmarks, and field borders.
Dispose of or clean sampling tools. Rinse pan, if used, with
isopropyl alcohol and flush with clean water before collecting
additional sediment samples.
Water
The following guidelines are for collecting samples of surface water
and are designed to detect pesticide residues in surface water such
as lakes, streams or ponds resulting from some type of misuse (i.e.,
off-site drift, overspray) of the pesticide. If pesticide contamination
of groundwater is suspected, contact the supervisor to determine
the appropriate federal, State, or local agency for follow-up.
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A determination should be made whether or not to wear shoulder-
length gloves and chest-high waders whenever contact is made with
potentially contaminated water.
Discrete Surface Water Sampling
Use two (2) clean one-liter amber glass containers with an
aluminum foil or Teflon seals under screw cap. Fill bottles to top
leaving no air space for pesticides to volatilize. Make sure samples
do not freeze [if amber glass containers are not available use two
(2) one-quart large mouth jars and wrap each bottle with aluminum
foil to exclude light].
Sample as close as possible to the apparent source of
contamination.
Avoid sampling sediment that is disturbed by your movement.
Wear shoulder-length gloves and chest-high waders if dermal
exposure may be a problem.
If the suspected pesticide is water soluble, the sample must be
drawn from a lower depth. If the pesticide is oil-based, or oil is a
part of the tank mix and the alleged misapplication was made
across the water surface, then the sample can be drawn from the
surface layer.
Lower the glass bottle to the desired depth with the cap on.
Remove the cap under water, and allow bottle to fill. Replace the
foil-lined (or Teflon lined) cap and lift the bottle out of the water.
For surface samples dip the bottle into the water surface and allow
it to fill. Jars must be filled completely to the rim, with no head
space and with the jar lid rubber seal down.
Several samples distributed around ponds or lakes are preferable to
only one sample. If only one sample is taken, draw several sub-
samples from different locations around the body of water and
combine as a composite into two (2) clean one-liter/quart
containers.
If the water is too shallow to immerse a jar, use another clean jar to
fill the sample jar.
Mark the location of the sample area on the diagram indicating
distances from each sample, landmarks and field borders.
Samples must be chilled or refrigerated and shipped as soon as
possible. DO NOT ALLOW SAMPLES TO FREEZE. An ice
chest with regular or "Blue-Ice" can be carried into the field for
this purpose.
Air
Generally, volume air sampling is conducted by the EPA laboratory
staff or Environmental Services Division (BSD) in concert with the
inspector. Since they have the unique equipment, chemicals,
knowledge, and experience needed to operate air sampling
equipment, it is recommended that they be contacted if volume air
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FIFRA Inspection Manual, February 2002
sampling is essential. The pesticide inspector will retain the lead for
the investigation and other personnel will assist.
Basically, there are two types of air samplers used. High Volume
(Hi-Vol) samplers used to measure low concentrations of pesticides
over long periods of time, and Low Volume (Lo-Vol) samplers
used to measure high concentrations of pesticides over shorter
periods of time. These are not hard, fast rules, and conditions often
dictate which sampler is best.
Both Hi-Vol and Lo-Vol samplers draw air through glass cylinders
containing a medium designed to trap the pesticides of interest.
Air Sampling Indoors
Either Hi-Vol or Lo-Vol samplers can be used depending on
expected concentrations. NOTE: Air samplers produce a moderate
noise. They should be positioned where they will not unnecessarily
disturb other persons in the structure, if possible.
Hi-Vol samplers must be vented out of the dwelling to ensure that
air will not be recycled through the machine.
Rooms with cigarette smoke or gas appliances must be avoided; any
gases or suspended smoke particles in the area will contaminate the
sample.
Air Sampling Outdoors
Either Hi-Vol or Lo-Vol samplers can be used outdoors.
Sampling equipment must be positioned to avoid exposure to
engine exhausts, running motors, cigarette smoke, or any other
non-target air contaminants.
Sampling equipment must also be protected from rain and direct
sprays from application machinery. Shelter hoods are used to
protect the equipment in such situations.
Use proper sample preparation and Sample Collection Recording.
Air samples must be sealed and delivered directly to the lab.
Pesticide Formulations (Technical Grade)
Sampling pesticide formulations for investigative purposes may be
necessary to provide evidence of pesticide misuse, misformulation,
product composition, cross-contamination or other problems. In
order for the analytical results of these samples to substantiate a
finding that a violation exists, the samples must be representative of
the total amount of the material sampled.
Each sampling situation in an investigation/inspection must be
judged separately as to number, type, and method. The following
general guidelines must be observed:
* Read and follow all precautionary statements on the label
before sampling a formulated pesticide material (i.e.,
protective clothing and equipment requirements). If a label is
Chapter Thirteen • Residue & Environmental Samples • 13-23
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FIFRA Inspection Manual, February 2002
not available, wear the maximum safety equipment (i.e.,
respirator, Tyvek suit, coveralls, rubber gloves, rubber boots,
and goggles).
* Wash thoroughly with soap and water before eating,
drinking, smoking or using the bathroom.
* If possible/practical, collect the entire container with its
contents. Smaller samples can always be collected from the
larger container at a later date.
* Since not every ounce of formulated pesticide material can
be sampled (e.g., bulk containers) and analyzed, design
sampling so all portions of the pesticide are "represented" in
the final sample.
*• Sample tools must be cleaned with hexane or alcohol and
rinsed with clean water or disposed of properly before
collecting additional samples.
*• Avoid cross-contaminating samples by keeping these
samples separate from all other samples (i.e., residue) at all
times. The following guidelines must be used to avoid cross-
contamination:
• Liquid bulk samples are to be collected in 8 02. amber glass
bottles with Teflon lined caps unless otherwise stated on
the label.
• Dry bulk samples are to be collected in glass pint or quart
jars, or pint metal type paint containers.
• Small retail packages can be collected as a sample. Four to
eight ounces of product is sufficient sample size.
* Use proper sample preparation and sample collection
recording. Review label for storage. Cool sample, unless
otherwise stated on the label. DO NOT ALLOW TO
FREEZE.
* Unless certified sterile containers are used, wash/rinse the
container and lid with hexane or alcohol and allow to air dry
prior to collecting the sample. Note this in the Sample
Collection Report.
Tank Mix
Laboratory analysis of tank mix samples will identify the active
ingredient and any possible contaminants in the tank mixture.
Analysis results can be reported as either percentage by weight or
parts per million.
It is the responsibility of investigators to protect themselves and
others during pesticide handling and sampling activities. Tank
mixes may be highly toxic. Protective clothing and safety
equipment must be used by investigators when sampling. Refer to
pesticide labels for precautionary statements. Rubber/Neoprene
Chapter Thirteen • Residue & Environmental Samples • 13-24
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FIFRA Inspection Manual, February 2002
gloves and goggles/face shield must be worn when sampling all
tank mixes. Wear a respirator if required by the label to protect
against vapors, dusts, or powders. If the tank mix ingredients are
unknown, assume they are the most hazardous and wear all
required safety equipment. Be careful when working around
machinery and at busy mixing/loading sites. Be aware of hoses and
fittings that may be under pressure or leak.
End use dilutions must be collected in glass 8 02. or 16 02. bottles.
Always use glass bottles or jars with Teflon lined caps (lids) or
hexane-washed foil-lined lids. Do not allow tank mix solutions to
contact rubber or plastic as these materials may affect the analytical
results. Do not use foil-lined lids if the pesticide reacts with metal.
Thoroughly agitate liquid in service container or tank.
Use a sterile or washed siphon tube and collect a composite sample
from three depths near tank bottom, middle, and near the top of
the liquid level. If the solution is adequately mixed to ensure
uniformity, a sample can be collected from the drain system.
Collect a composite sample from as many points in the drain
system as are available. Application rigs can be sampled at spray
boom no22les. Following actual application, have the operator
loosen boom nozzle and drain the pesticide mix into a glass sample
container. Be sure that the operator tightens the no22les on the
boom after the sample has been taken.
To reduce the possibility of spillage, do not fill the sample jar or
bottle above the bottom of the thread line. If the pesticide is highly
volatile, fill to the top of the jar to prevent volatili2ation into the air
space.
Use proper sample preparation and Sample Collection Recording.
DO NOT ALLOW TO FREEZE.
Decontaminate all tools and change or wash gloves to prevent
cross-contamination of samples. Do not store or ship tank mix
samples with or near foliage or soil samples.
After collecting the samples wash thoroughly with soap and water
before eating, drinking, smoking or using the rest room.
For specific sampling procedures for a particular sampling
situation, investigators should discuss with the supervisor or
laboratory personnel the protocol that is appropriate for the
particular situation at hand.
Animals, Fish, Honeybee Sampling
Dead animals, fish, and honeybees must be sampled fresh before
decomposition, if possible.
Use disposable gloves when handling animal samples because of
the possibility of disease transmission.
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Small animals and fish must be placed in a heavy, inverted
polyethylene bag, properly identified, and frozen as soon as
possible. At least 500 grams is needed per sample.
Collect a minimum of four ounces of fresh dead bees or honey and
a minimum of one ounce of pollen. Remember to collect enough
for each analysis requested. Place sample in a clean, unused jar.
Use proper sample preparation and sample collection recording.
Chill all animal, fish, and bee samples as they are collected to
prevent further degradation. If decomposition is evident, upon
collection indicate so on the Sample Collection Record.
Freeze and ship all tissue samples as quickly as possible.
Maintain a Chain of Custody.
Surface (Wipe) Sampling
Surface or wipe sampling is conducted to establish the presence of
a pesticide on a surface.
Discrete Surface Sampling
Equipment needed:
* Disposable latex gloves
* Solvent (isopropyl alcohol or hexane)
* Sterile pad
* Disposable paper template
*• Permanent marker
* Large polyethylene bag
Discrete surface sampling include the following steps:
* Collect Control Sample. Before entering the area to be
sampled take a control sample. While wearing disposable
gloves, pour the solvent over the sterile pad. Do not
contaminate the solvent by placing the pad over the mouth
of the solvent bottle. The control sample must be prepared
and identified following the procedures outlined below.
*• Select Target Site. When possible select a site showing
visible residue. Try to avoid areas known to contain waxes
because they may interfere with the analysis. Smooth "inert"
surfaces are the preferred area to collect the sample (i.e.,
windshield, etc.). Sampling uneven surfaces (such as rugs,
furniture, walls, walkways, counters), however, is also
possible.
*• Prepare Sample Site. While wearing disposable gloves, tape
a template to sample surface. The template will delineate the
sample area at the target site. A new template and gloves
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FIFRA Inspection Manual, February 2002
must be used for each sample location. If a template cannot
be placed on target site, delineate the sample area using
masking tape of approximately 100 square centimeters in
area. Photograph the area as necessary.
*• Collect Wipe Sample. Surface areas are sampled using a
sterile cotton pads (2" x 3") or filter paper discs moistened
with solvent. While wearing disposable gloves, pour
isopropanol or hexane over the foam pad and moisten it
completely. Shake off excess solvent. Do not contaminate
the solvent by placing the foam pad over the mouth of the
solvent bottle. The target area of the template is to be
completely wiped, with circular motions and back-and-forth
motions, with the first side of the wipe swabbed in a
consistent direction 90 degrees to the first swabbing.
Depending on the surface conditions, wipes may also have
to be taken by dabbing the surface area within the template.
*• Prepare Sample. Place the sampling pad in the jar, can, or
other appropriate sample container. Using a permanent
marker, identify the sample collection number, date, and
inspector's initials on the sample container. Place each
sample collected in a large polyethylene bag and follow the
procedures outlined. To document the area sampled, take a
photograph of the sample area to include: the area wiped,
the sealed sample container, and the template still in place.
>• Prepare Collection Record. Record the surface area type and
sample location on the Sample Collection Record, on the
incident diagram, and in the investigative notes. Other
information recorded on the Sample Collection Record.
Form includes the following: the solvent used, the suspected
ingredients in the pesticide spray solution, and whether the
surface sample represents pesticides in concentrate, tank
mix, or residue from drift or overspray.
>• Sample storage and shipment. Store the samples in the
freezer or refrigerator and ship on dry ice. Pack the Sample
Collection Record and samples in the same manner as the
soil/foliage samples.
Grid Pattern Surface Sampling
Grid pattern samples are taken to establish uniform or partial
contamination of the incident site. They can be used to delineate a
contaminated site (treatment site) from non-treated sites. For
example, it may need to be proven that a broadcast carpet
treatment occurred when labeling only allowed a baseboard
treatment.
Collect samples in a grid pattern following the procedures indicated
for a discrete surface sample, as described above. Each sample
represents one point on the grid for that site. Do not composite the
Chapter Thirteen • Residue & Environmental Samples • 13-27
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FIFRA Inspection Manual, February 2002
samples. Always collect a solvent control sample prior to any other
sampling.
If the site is suspected of being partially contaminated, start sample
collection in the area of least contamination.
If multiple analyses will be requested, collect companion samples.
Surface samples must be collected from similar surface areas.
Identify on the diagram the location and area from which each
sample was taken, with distances from landmarks, walls, and
between samples clearly indicated.
Use proper sample preparation and Sample Collection Recording.
Gradient Surface Sampling
Gradient surface samples are taken to establish a drift pattern in or
on a structure. Always sample from an area of lowest concentration
in a direction towards the area of highest concentration (treatment
site) to prevent contamination of samples.
Samples must be collected from defined areas at the site similar to
methods indicated in the procedures for a discrete surface sample.
Always collect a solvent control sample prior to any other sampling.
Collect samples in a pattern at an equal distance apart with at least
one sample outside of the contaminated area (if possible) and one
or more samples from the suspected source area of contamination.
The gradient pattern must be in a straight line.
If multiple analyses will be requested, collect companion samples
for a discrete surface sample.
Collect samples from similar surface areas. Identify the location on
the diagram and the area from which each sample was taken.
Include distances from landmarks, walls, and between samples.
Use proper sample preparation & Sample Collection Recording.
Clothing
Be selective when collecting clothing samples. Collect clothing only
from people who were allegedly contaminated. Consideration must
be given to the type of incident involved. Garments, such as shoes
(footwear), could be collected if an applicator was allegedly exposed
to a pesticide because of failure to wear protective equipment.
Shirts, scarves, or jackets could be collected if they were exposed to
pesticide drift.
Clothing samples are usually collected away from the incident site.
Should the history of the clothing be unknown, attempt to find out
more about the integrity of the sample. Ask the people involved if
the clothing has been washed since the incident. If the clothing has
been washed, the investigator must not collect the sample unless
there are special circumstances which dictate sampling. Consult
with the supervisor for guidance if unsure.
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Inform those people involved that the clothing will not be
returned.
Wrap each article in aluminum foil prior to placing it into the poly-
bag.
Place each sample in a separate large, inverted 12" x 30" heavy
polyethylene bag. Properly knot and seal each bag. Identify and
officially seal samples immediately as they are taken.
Use proper sample preparation & Sample Collection Recording.
When submitting clothing samples for analyses, consideration must
be given to the type of incident involved. Clothing samples are
collected to determine if pesticide residues are present. They are
not used to determine whether the exposure resulted in a health
hazard. If the affected area of the clothing is known (i.e., spot
caused by spill), the investigator could cut the affected area out and
submit it to the laboratory. In some situations it might be better to
submit the entire garment. Indicate on the Sample Collection
Record the area of the clothing the Laboratory should analyze (i.e.,
shoulder, sleeve, front, etc.).
SAMPLE STORAGE, PRESERVATION, AND SHIPPING
The proper collection, storage and shipping of samples are all
critical elements of the sampling process and can affect the analysis
results. Steps must be taken early in the sampling process to avoid
anything that could compromise the integrity of the sample, such as
loss, contamination or tampering.
Ideally, samples should be analyzed as soon as possible after they
are collected. In many situations, however, this may not be possible
and consideration must then be given to assuring the integrity of
the sample by utilizing proper storage, preservation, and shipping
methods.
Storage and Preservation
If samples must be stored temporarily, it is best to refrigerate or
even freeze them to prevent deterioration of the sample and
degradation of the chemical. Contact the supervisor or laboratory if
in doubt about the specific requirements for storage of a particular
kind of sample.
All samples should be stored in an insulated cooler to protect from
extreme heat and cold during the transit to the laboratory from the
time of collection. In extreme hot conditions, it may be necessary
to include ice inside the cooler in order to maintain the integrity of
the sample. The inspector should read and follow the label
statement for storing the samples under or over the listed
temperatures.
Chapter Thirteen • Residue & Environmental Samples • 13-29
-------
FIFRA Inspection Manual, February 2002
Table 13-1 summarizes the general requirements for preserving
various sample types during storage (i.e., field and laboratory) and
shipping to the laboratory. Refer to the specific sample type in the
"Sampling Procedures" section of Chapter 9 in this manual for
additional information.
Chapter Thirteen • Residue & Environmental Samples • 13-30
-------
FIFRA Inspection Manual, February 2002
Table 13-1: Sample Preservation
Sample Type
Container
Field
Storage
Ship
Fo//age
Discrete
Grid
Gradient
Composite
Dislodgeable
Commodity
(field, packed)
PB
PB
PB
PB
GJ
PB
C
C
C
C
C
C
F
F
F
F
R
R
Dl
Dl
Dl
Dl
Wl
Wl
So/7
Discrete (surface)
Discrete
(known depth)
Discrete
(furrowed field)
Grid
Gradient
Composite
Sediment
Water
Air
Animals, fish, honeybees
GJ
GJ
GJ
GJ
GJ
GJ
GJ
GJ
GJ
GJ
C
C
C
C
C
C
C
Wl
Dl
C
F
F
F
F
F
F
F
R
F
F
Dl
Dl
Dl
Dl
Dl
Dl
Dl
Wl
Dl
Dl
Surface
Wipe
Grid
Gradient
Clothing
Tank-Mix
GJ
GJ
GJ
PB
GJ
C
C
C
C
C
F
F
F
F
R
Dl
Dl
Dl
Dl
Wl
NOTE: All sample containers are to be sealed in a plastic bag in the field.
(C)-Chill (Wet Ice or "Blue-Ice")
(Dl) —Dry Ice
(F) — Freeze
(GJ) — Glass Jar/sealed in Plastic Bag
(R) — Refrigerate
(PB) — Sealed in Plastic Bag
(Wl) - Wet Ice
Chapter Thirteen • Residue & Environmental Samples • 13-31
-------
FIFRA Inspection Manual, February 2002
Shipping Procedures
Packaging and shipping samples must be done properly, using care
to ensure that they remain intact when they arrive at the laboratory.
Pesticide formulation samples must be packaged to avoid spillage,
leakage or deterioration and the possibility of endangering the
safety of persons or the environment. Ship samples in accordance
with Department of Transportation (DOT) regulations. Maintain
the Chain of Custody.
The following are general guidelines to be observed when
packaging samples for shipping:
* Determine if the sample is considered hazardous material
under U.S. DOT regulations, (49 CFR Part 172.101) as these
materials require special packaging, labeling, and UPS
procedures. In most cases, UPS will be utilized for sample
shipment to the lab. Do not send samples through the Parcel
Post. Most of the samples that are collected are NOT
considered hazardous materials.
*• Investigative samples must be shipped to the laboratory as
soon as possible, but must not be shipped on Friday unless
special laboratory arrangements are made, since the samples
would not be delivered to the laboratory until the following
Monday. Samples held over the weekend must be kept
under dry ice, chemical ice, or contained wet ice. Routine
samples must be shipped weekly, on any day of the week.
* Samples to be analyzed for pesticide residues (foliage, soil,
water, animal etc.) Require that a temperature be maintained
during shipping that will prevent deterioration. Refer to the
Sample Preservation Table.
*• Samples must be carefully packed in coolers and sealed with
fiber reinforced tape to avoid breakage in transit. Samples
should be packed with plenty of crumpled newspapers or
similar material. If there are several samples, do not ship
both liquid and dry samples in the same cooler, if at all
possible.
* Under no circumstances should pesticide samples be
shipped in the same carton with samples of feed, fertilizer,
or seed.
*• UPS will not ship any single carton weighing over seventy
(70) pounds.
* Place properly bagged and labeled samples in shipping
container and immobilize samples with suitable packing
material such as crumpled newspaper or styrofoam. Seal the
shipping container.
Chapter Thirteen • Residue & Environmental Samples • 13-32
-------
IF AT ANY TIME
THERE IS A QUESTION
REGARDING PROPER
SHIPPING
PROCEDURES FORA
PRODUCT, PLEASE
CALL YOUR
SUPERVISOR.
FIFRA Inspection Manual, February 2002
*• Pack liquid samples in sufficient absorbent material to
absorb and retain any leakage that might occur. It may be
necessary to "over pack" the sample.
* Clearly mark shipping container with handling instructions,
such as "Handle With Care," "Glass," "This Side Up," or
other appropriate wording.
* Comply with all applicable packaging and shipping
requirements of DOT.
* Ship or deliver the samples to the appropriate location as
soon as possible and maintain Chain of Custody.
* No special markings or diamond DOT labels are required on
the package, unless the product samples are classified as
hazardous.
Hazardous Materials Shipments - UPS & FEDEX Procedures
The above procedures are not sufficient to ship samples of
products classified by DOT as hazardous. Hazardous classifications
are generally based on three independent elements:
*• Toxitity. Shipment of any pesticide formulation sample
which bears a label containing the signal words "DANGER -
POISON". These products may be sampled as
"Documentary Samples", or upon request from the office,
will be collected and hand delivered to the lab. These
products have an LD 50 of 50 milligrams/kilogram and are
considered as Class A or Class B poisons. UPS will not ship
pesticides which are in the "POISON" hazard class without
very special packaging.
*• Flammability. Any pesticide product with a flash point
below 100° F. is considered a hazardous material. Look for
"Flammable" DOT diamond stickers on the container or
shipping carton of the product or for statements on the label
such as: "Do not use near heat or open flame." Limited
amounts of flammable products may be shipped by UPS.
* Corrosiveness. Corrosive substances are those which cause
irreversible skin damage. The label on these products will
read "Corrosive-causes eye and skin damage". Most bowl
cleaner - sanitizer products will be in this class. Most of these
can be shipped in the same manner as flammable liquids.
Except in rare circumstances, the only hazardous materials that will
be encountered are some of the pesticide formulations that have
been sampled. Residue and pesticide impregnated fertilizer samples
normally fall outside of the "hazardous" definition because of the
low concentrations of pesticide active ingredient actually present.
All samples must be shipped via UPS or FEDEX, motor frieght, or
transported by the inspector, and NEVER U.S. mail.
Chapter Thirteen • Residue & Environmental Samples • 13-33
-------
FIFRA Inspection Manual, February 2002
Investigator's Shipment Procedures
The following procedures should assist the investigator in shipping
samples via UPS or Federal Express (FedEx) in compliance with
applicable regulations.
Look for DOT diamond labels indicating "POISON,"
"FLAMMABLE," or "CORROSIVE" on the product container, or
shipping carton. Again, do not collect or ship any pesticide bearing
the signal word "POISON."
UPS Shipments
Look for the name of the pesticide or the pesticide active
ingredient under the list entitled "Hazardous Materials Shipping
Names - UPS." If the chemical name is found under this list, the
investigator will need to take the following actions:
*• Complete a UPS five part UPS Hazardous Material Form
(U1114), a Shipper Certification Form (U1208), and a
standard UPS shipping form (U1203) (call 1-800-742-5877 to
order these forms directly from UPS).
*• In order to comply with Department of Transportation
regulations (49 CFR 177.817) UPS shippers of Hazardous
Materials must prepare a UPS Hazardous Materials Form
(Form U1114) for each parcel requiring documentation. All
entries must be legible and printed manually or
mechanically in English. Affix form to the parcel, next to the
address label. (Note: UPS Hazardous Materials Form does
not replace or supersede other labels or marking required by
the DOT). Remember that ORM items do not require a 5 part
form (U1114) or UPS shipper certification (U1208), unless
they meet the definition of a hazardous substance.
*• Form U1208 must state the complete and correct DOT
shipping name, hazard class, identification number, and
DOT label required as specified under the shipment name
list. Also state the amount of material actually being
shipped. Do not ship any other samples with any sample
considered hazardous. Write the shipping name of the
chemical on the outside of the shipping carton.
If the pesticide is not on the list, but there is a diamond sticker,
select the appropriate shipping name for the following choices:
* Compound, weed killing liquid (flammable or corrosive)
FLAMMABLE LIQUID NA1993 or CORROSIVE MATERIAL
NA1760.
* Compound, weed killing solid (oxidizer). OXIDIZER
AN1479.
> Disinfectant, liquid (corrosive). CORROSIVE MATERIAL
UN1903.
Chapter Thirteen • Residue & Environmental Samples • 13-34
-------
FIFRA Inspection Manual, February 2002
> Insecticide, liquid, N.O.S. (flammable) FLAMMABLE
LIQUID NA1993
UPS packages must be shipped using the following methods:
*• Packages can be dropped off at UPS customer counters.
Since the counters are open only at certain times
during the day, determine the hours of
service of the counters for most efficient use.
*• For an additional charge, UPS will pick up a package at any
location. Use the following procedures for package pick-up:
* Samples must be packed and labeled as indicated above. It
will be necessary to weigh or estimate the weight of the
package.
* Phone UPS at 800-242-2111 the day before the carton is to be
picked up. UPS will visit the same pick-up point each day
for the remainder of the week for the one time per week
charge, if desired. Initially, an appointment will need to be
made with a UPS representative to establish a UPS shipper
number.
* If the samples are classified as hazardous materials,
complete a five part UPS hazardous material form (U1114)
and attach it to the carton. See Table 13-2 for a list of UPS
hazardous materials shipping names.
*• For any shipment, also complete a UPS form U1203.After
initial establishment of the shipment number, UPS shipping
costs will be billed directly to your account. Retain copies of
the shipping forms for future shipping documentation.
Chapter Thirteen • Residue & Environmental Samples • 13-35
-------
FIFRA Inspection Manual, February 2002
Table 13-2 - Hazardous Materials Shipping Names - United Parcel Service
Product — Proper Shipping Name (DOT Label Reg.)
Hazard Class — ID. No.
Special Instructions
#1
#3
#5
#7
#9
#11
#13
#15
#17
#19
Allethrin (none)
ORM-A-NA2902
Package Marking Only
Azinophos Methyl Mixture Liquid
POISON B NA2783
DO NOT SHIP
Cadmium Sulfate N.O.S. (none)
ORM-ANA1693
Package Marking Only
Carbamate Pesticide Liquid N.O.S.
FLAMMABLE LIQUID UN2757
Carbofuran
POISON B NA2757
DO NOT SHIP
Diazonin (none if less than 1 Ib.)
Package Marking Only
Dichloropropene & Propylene
Dichloride Mixture
FLAMMABLE LIQUID NA2047
Disulfoton Mixture Dry N.O.S.
POISON B NA2761
DO NOT SHIP
Ethylene Dibromide (none)
ORM-AUN1605
Package Marking Only
Ethylene Oxide UN1 040
FLAMMABLE LIQUID
#2
#4
#6
#8
#10
#12
#14
#16
#18
#20
Aluminum Phosphide
FLAMMABLE SOLID UN1 397
Bipyridilium Pesticide Liquid N.O.S.
POISON B NA2783
DO NOT SHIP
Carbamate Pesticide Solid N.O.S.
(none) ORN-A NA2757
Carbaryl (none)
ORM-A 2757
Package Marking Only
Carbon Tetrachloride
ORM-A NA1 693 (none)
Package Marking Only
2,4-Dichlorophenoxy-acetic(none)
ORM-A NA2765
Package Marking Only
Dinoseb — See #29
Endosulfan Mixture Liquid N.O.S.
POISON B NA2761
DO NOT SHIP
Ethylene Dichloride
FLAMMABLE LIQUID UN1 184
Formaldehyde Solution
(Flammable or none) ORM-A
UN1198 Package Marking Only
Chapter Thirteen • Residue & Environmental Samples • 13-36
-------
FIFRA Inspection Manual, February 2002
Product — Proper Shipping Name (DOT Label Reg.)
Hazard Class — ID. No.
Special Instructions
#21
#23
#25
#27
#29
#31
#33
Hypochlorite Solution
(Corrosive if over 7%)
CORROSIVE UN1 791 or
ORM-BNA1791
If ORM-B, Package Marking Only
Malathion (none)
ORM-A
Package Marking Only
Naphthalene (none)
ORM-A UN1 334
Package Marking Only
Propionic Acid
UN1848
CORROSIVE MATERIAL
Substituted Nitrophenol Liquid N.O.S.
Flammable or Poison B
FLAMMABLE LIQUID UN2780
DO NOT SHIP IF POISON B
Toxaphene (none)
ORM-A NA2761
Package Marking Only
Zinc Chloride Solution
CORROSIVE MATERIAL UN1840
#22
#24
#26
#28
#30
#32
#34
Lindane (none)
ORM-A NA2761
If under 1 1b. Package Marking Only
RQ Methoxychlor
(if over 1 Ib.)
ORM-E NA2761
Paraquat (Gromoxone)
See #4
Sodium Chlorate
OXIDIZERUN1495
Thiram (none)
ORM-A NA2771
Package Marking Only
Triazine Pesticide Liquid N.O.S.
FLAMMABLE LIQUID UN2764
Zinc Phosphide
POISON BUN1714
DO NOT SHIP
FedEx Shipments
The package must meet all applicable DOT packaging, marking,
and labeling requirements before it can be shipped by FedEx. See
Table 13-3 for packaging, marking, and labeling requirements.
Complete the FedEx Dangerous Good Airbill (Exhibit 13-1) (call
1-800-463-3339 to order these forms directly from FedEx). See
Table 13-4 for instructions on how to complete the FedEx
Dangerous Goods Airbill. If you need further help completing this
form, call 1-800-463-3339, ext 922-1666 for assistance.
To determine the proper shipping name, use the UPS hazardous
materials shipping name (see Table 13-2) or, if there is a diamond
sticker on the container, select the appropriate shipping name from
the following choices:
Chapter Thirteen • Residue & Environmental Samples • 13-37
-------
FIFRA Inspection Manual, February 2002
* Compound, weed killing liquid (flammable or corrosive)
FLAMMABLE LIQUID NA1993 or CORROSIVE MATERIAL
NA1760.
*• Compound, weed killing solid (oxidizer). OXIDIZER
AN1479.
> Disinfectant, liquid (corrosive). CORROSIVE MATERIAL
UN1903.
> Insecticide, liquid, N.O.S. (flammable) FLAMMABLE
LIQUID NA1993.
Packages can be dropped off at any FedEx customer location. A
FedEx employee will need to examine the package to determine if
it can be transported by FedEx. Retain copies of the shipping
forms for shipping documentation.
Chapter Thirteen • Residue & Environmental Samples • 13-38
-------
FIFRA Inspection Manual, February 2002
Table 13-3: FEDEX Packaging, Marking, and Labeling Requirements
Packaging Requirements
Package should be in good condition, free of external damage, leakage, or odors.
Package must be permitted by the packing instruction .
If UN specification packaging is used, X (PG I, II, or III), Y (PG II or III), or Z (PG III), it must
correspond with the packing group.
Toxics in packina groups I or II (primary or subsidiary risk) - package is DOT Exemption
packaging for U.b. domestic or ^/-Rated" for international.
Marking Requirements
Package must be marked with the proper shipping name (and technical name(s) in parentheses
for asterisked entries).
Package must be marked with UN or ID number preceded by the prefix "UN" or "ID.
Package must be marked with the name and address of shipper and consignee.
If Applicable:
If a "Y" packing instruction is used, "Limited Quantity" or "LTD QTY" must be specified.
Netweight of dry ice (in kg) is specified.
The words "Do Not Drop-Handle with Care" on the package. "Keep Upright" must be at 120
degree intervals around the package. Arrows or orientation labels must be affixed. Instructions
in fine event of emergency, delay, or if shipment remains unclaimed should be included.
When an overpack is indicated on the shipper's declaration, all aspects comply, including: a.
the dangerous goods are compatible; b. if UN. specification packagings are used, the statement
"Inner packages comply with prescribed specifications" is marked on the package.
"RQ" is marked on the package when written on the declaration.
"DOT -E-####" is marked on the package when shipped as a DOT Exemption.
Labeling Requirements
The correct primary risk label(s) must be used. The number must be indicated on the bottom
corner.
The correct subsidiary risk label(s) must be used, if applicable. The number must not be
indicated on tne bottom corner.
Use a "Cargo Aircraft Only" label (Danger), if applicable.
For liquids in combination packaging and overpacks, two package orientation labels (arrows up)
on opposite sides are required(these labels are not required for "Class 3 if inner receptacles are
120 ml or less, or for Class 6.2, if inner receptacles are 50 ml or less).
Labels must be correctly applied and not obscured; irrelevant markings/labels must be removed.
ppointmen wi nee to e mae wit a representaive to estais a sipper
Chapter Thirteen • Residue & Environmental Samples • 13-39
-------
FIFRA Inspection Manual, February 2002
Table 13-4: FedEx Dangerous Goods Airbill Instructions
Shipper's, Payment, and Service Information
nc ude the name and address of shipper.
nclude the name and address of consignee.
ndicate page of pages.
ynderJcansp.ort.D.etails, correctly indicate whether item is packed within Passenger or Cargo
Aircraft Onfylimiiations. ' K a a
Under shipment Type, cross out the word "Radioactive."
Nature & Quantity of Dangerous Goods (bottom of form)
Include the proper shipping name (and technical name[s] in parentheses for asterisked entries).
Indjcate the Class or Division number(s) (and Class 1, compatibility group).
Indicate the UN or ID number, preceded by the prefix "UN" or "ID.
Include the packing group number, when applicable (i.e., I, II, or III).
Include the subsidiary risk number(s), when applicable, corresponding to the subsidiary risk
label(s) applied (step 5).
Indicate the number and type of package(s) (i.e., 1 fibreboard box or 1 4G).
Include the total net quantity per package (must be in metric units).
Indicate the packing instruction number (i.e., 307 or Y419).
Provide authorization information (name and title of signatory, place, and date).
Sign the form.
information Jncludejhe^
•equired for mag_netized material, consumer commodity, LTD OTY., Castor" PSNs
); no beeper or pager numbers should be used.
If Applicable:
If a "Y" packing instruction is used, "Limited Quantity" or "LTD. QTY" must be specified.
When an overpack is indicated,.,all aspects.must comply, including:, a, the dangerous goods
must be compatible; and b. if UN" specification packagmcteare used, the statement Inner
packages comply with prescribed specifications Hs marked on the package.
When all packed in one outer package" is indicated on the declaration, the dangerous goods
must be compatible and a "Q value" should be listed (not required for dry ice).
Include the shipper's full signature next to amendments or alterations.
The forp-i should indicate "DOT.-E=####".in authorization column when shipped as a DOT
Exemption. A current copy ofthe txemption must travel with the shipment^
RQ should be written on the form when marked on the package.
Chapter Thirteen • Residue & Environmental Samples • 13-40
-------
FIFRA Inspection Manual, February 2002
Exhibit 13-1: FedEx Dangerous Goods Airbill
Dangerous Goods
Airbill
Sender's Copy
RETAIN THIS COPY FOR YOUR RECORDS
m, rr/ r r s\ m'
The World On Time
mm FfOffi Please e
Seder's FedEx
. Account Mumb&r __
t SS SACK Of SC?^5Cft S CCPf flf Th
&M Hia feUix Sanies G
Questions? Call 1«80O-Go«FedEx' (800463-3339J o
VUit our W«b tit* «t Mfww,f*d«x.com
El Packaging
City —
HVouf Internal Bilging Rsfefeme*
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. SUM ZIP_
I Other Packaging
caonol bs shipped in FedEx pj
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j,M±tM iw f tSti ^swt
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CD Express Package Service Packages up ioi so tin.
| ] fetflU Priority Ovsmight | | Fsd'Ex Standard Qvumkj3n
ni
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Signature Release unavailable ,-.N-,» H.,;V,F,.^ •,•?•;•,.,.:,..
fiU Express Freight Service
l fed& I Day Freight*
r^/te
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Page J_ of JL Pages fiv* ««
TRANSPORT DETAILS
SSS^S^*!*!"
[ PASS€N6I8~~~1 CARGO
ANO CARGO ASSCfiAFT
AJRCRAfT i ONtf 1
Aifport of Dealt n alien:
WAKN
Failure
breach
circum
agent.
mpteted and signed copies of this Declaration must be handed to the operator.
ING
lo comply in all respects with the applicable Dangerous Goods Regulations may be ir.
of the applicable law, subject to legal penalties. This Declaration must not, in any
stances, be completed and/or signed by a consolidalor, a forwarder or an (ATA cargo
Shipment type; idtleta nwi
NON-RADIOACTIVE
NATURE AND QUANTITY OF DANGEROUS GOODS
Dangerous Goods Identification
Proper Shipping Name
Class
or
Division
UN
or
ID No.
Packing
Group
Subsi-
diary
Risk
pplicaMf)
RADIOACTIVE
Quantity and
Type of Packaging
Additions) Handling tfiformalion
1 hereby declare that (.he contents of this consignment are fully and accurately described above by the proper
shipping name and ate classified, packaged, marked, and labeled/placarded, and are in all respects in proper
condition for transport according to applicable international and nationa governmental reQulations,
Emergency fefaciNw* Nusuber (ftflfliiiired doc U.S. Qrsgsrs of (HsJWSlM)^ Shifters nij)
Packing
Irvstr.
Authorization
Prepared for AIR TRANSPORT according lo: ,
(Customer MUST check one)
D49CFR D ICAO/IATA
Name/ThNso*
Date
Signature
I1*** wtmifiig
«**>**?
IF ACCEPTABLE FOB PASSENGER AIRCRAFT, THIS SHIPMENT CONTAINS RADIOACTIVE MATERIAL INTENDED FOR USE IN. OR INCIDENT TO, RESEARCH, MEDICAL DIAGNOSIS. OR TREATMENT.
Chapter Thirteen • Residue & Environmental Samples • 13-41
-------
Chapter Fourteen
PESTICIDE IMPORT AND EXPORT PROGRAM
Table of Contents
Page
AUTHORITY 14-1
OBJECTIVE 14-2
REQUIREMENTS 14-2
Exports 14-2
EPA Registered Pesticides That Are Exported with EPA
Registered Labels 14-2
Unregistered Pesticides Which Are Similar in Use and
Composition to a Registered Pesticide, as Defined in the Export
Policy 14-2
PROCEDURES 14-3
Exports 14-3
Inspection and Sampling 14-3
Pre-inspection Activities (Regional Office Function) 14-4
On-Site Inspection Activities (Regional/State Function) 14-4
Imports 14-6
Import of Unregistered Pesticides 14-6
Import of Pesticides That Are Exempt From FIFRA
Regulations 14-7
Import of Registered Pesticides and Devices 14-7
Regional Office 14-7
Customs 14-9
Inspections and Sampling 14-9
Import Sampling 14-9
Inspection Without Sampling 14-10
Regional Office Procedure After Inspection 14-10
Merchandise Complying With the Act 14-10
Merchandise Not Complying With the Act 14-10
Exhibit 14-1: 40 CFR Sections 168.65 to 168.85 14-12
Exhibit 14-2: FIFRA Export Inspection Checklist 14-22
Exhibit 14-3: Pesticide Registration (PR) Notice 99-1 14-25
Exhibit 14-4: Notice of Arrival of Pesticides and Devices (EPA Form
3540-1) 14-28
Exhibit 14-5: 19 CFR Sections 12.110 to 12.117 14-29
Exhibit 14-6: FIFRA Import Inspection Checklist 14-31
Exhibit 14-7: Model Release Notice 14-33
Exhibit 14-8: Model Notice of Refusal of Admission 14-34
Exhibit 14-9: Model Notice of Detention and Hearing 14-35
Exhibit 14-10: 19 CFR Section 12.1 14-36
Exhibit 14-11: 19 CFR Sections 113.61 to 113.62 14-37
Exhibit 14-12: 19 CFR Sections 142.21 to 142.22 14-40
Chapter Fourteen • Pesticide Import & Export Program • 14-i
-------
CHAPTER FOURTEEN
PESTICIDE IMPORT
AND EXPORT
PROGRAM
AUTHORITY
Section 17 (a) of the Federal Insecticide, Fungicide and Rodenticide
Act (FIFRA) states in part:
Notwithstanding any other provision [of] this Act, no pesticide or
device or active ingredient used in producing a pesticide intended
solely for export to any foreign country shall be deemed in
violation of this Act -
(1) when prepared or packed according to the specifications or
directions of the foreign purchaser, except that producers of such
pesticides and devices and active ingredients used in producing
pesticides shall be subject to sections 2(p), 2(q)(l)(A), (C), (D), (E),
(G), and (H), 2(q)(2)(A), (B), (C)(i) and (in), and (D), 7, and 8 of
this Act; and
(2) in the case of any pesticide other than a pesticide registered
under section 3 or sold under section 6(a)(l) of this Act, if, prior to
export, the foreign purchaser has signed a statement acknowledging
that the purchaser understands that such pesticide is not registered
for use in the United States and cannot be sold in the United States
under this Act.
A copy of that statement shall be transmitted to an appropriate
official of the government of the importing country.
Section 17(c) of the Act directs the Secretary of the Treasury to:
notify the Administrator of the arrival of pesticides and devices;
and deliver to the Administrator (upon his/her request) samples of
pesticides or devices which are being imported into the United
States.
[See Section 17 of FIFRA for complete statute information, and the
supporting regulations at 40 CFR 168, Subpart D, and additionally,
19 CFR 12.110 - 12.117 (Exhibit 14-1 and 14-5)].
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OBJECTIVE
The objective is to ensure that pesticides and devices imported into
or exported from the United States comply with the requirements
of FIFRA. Imported pesticides and devices that are found not to
be in compliance must be detained and, if those items are not
brought into compliance, must be refused entry.
REQUIREMENTS
Exports
All exported pesticides are subject to the labeling requirements of
FIFRA. In addition, certain label items must be in both the
English language and in the language of the importing country, if
English is not the predominantly spoken language or the language
used in conducting official business in the importing country.
The following label items are subject to the bilingual requirement:
*• The warning and caution statements.
*• The ingredient statement.
*• Where required, the word "poison" and the statement of
practical treatment (first aid).
For the purposes of regulating the exportation of pesticides, the
Export Policy divides exported pesticides into categories, as
outlined below, with differing requirements for each category.
EPA Registered Pesticides That Are Exported with EPA Registered
Labels.
The only additional requirement for the exportation of EPA
registered pesticides with EPA approved labels, is that certain of
the label items (the warning and caution statements, the ingredient
statement, and when required, the word "poison" and the
statement of practical treatment) must be in both the English
language and in the language of the importing country, if English is
not the predominantly spoken language or the language used in
conducting official business in the importing country.
Unregistered Pesticides Which Are Similar in Use and Composition
to a Registered Pesticide, as Defined in the Export Policy.
The use of bilingual labeling when being exported to non-English
speaking countries.
The labels must include the statement "Not Registered for Use in
the United States of America."
A signed statement from the foreign purchaser of the unregistered
pesticide acknowledging that the purchaser understands that the
pesticide is not registered for use in the United States and cannot
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be sold in the United States. This statement must be obtained prior
to the first shipment of a particular pesticide to a particular
purchaser for each country annually i.e. Foreign Purchaser
Acknowledgment Statement (FPAS)..
PROCEDURES
Exports
Inspection and Sampling
Pesticides may be exported from the United States whether they are
registered, unregistered, canceled or suspended — provided certain
criteria are met. Export Inspections are generally conducted at
producing establishments, but pesticides intended for export may
be encountered during port visits or Marketplace Inspections where
pesticides might be stored pending export.
Procedures
For routine inspections, the general requirements are to verify
compliance with the export regulations. A checklist (Exhibit 14-2)
is provided to assist inspectors to ensure that all requisite activities
have been covered. For "For Cause" Inspections, follow the
specific instructions on the EPA referral.
Most export inspections will be included along with section 8
Books and Records inspections conducted at pesticide producer
establishments. These will involve the review and collection of
export pesticide labels, shipping documents, sales invoices,
statements and other documents which can be used to document
the export of pesticide products. Pesticides for export can be
contract produced and shipped domestically to another company
for exportation. In these cases it may be necessary to conduct the
inspection at the pesticide-producing establishment and the
company that is actually responsible for the exportation of the
product. (For more information on Producer Establishment
Inspections see Chapter 7 of this manual).
The inspector shall secure a copy of the Foreign Purchaser
Acknowledgment Statement (FPAS) for each unregistered pesticide
and cross-reference the date of the exporters receipt of the FPAS
with the actual date of sale or distribution of the unregistered
pesticide, whether that distribution be from the contract
manufacturer, various warehouse facilities, shipping contractors etc.
The unregistered pesticide cannot legally move until the FPAS is
received by the exporter. Any sale or distribution of the
unregistered pesticide prior to the exporters receipt of the FPAS is
unlawful, unless otherwise exempted by FIFRA and FIFRA
regulations.
During export inspections the inspector, through discussions with
responsible company officials and subsequent review of company
records, must be able to clearly document the items identified
below. When information is not available or cannot be clearly
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documented by obtaining copies of records, the inspector must
obtain statements from responsible company officials that clearly
document the procedures used by the company when exporting
pesticides.
Some of the information to be obtained during these inspections
may be claimed as FIFRA CBI. Only Federal FIFRA CBI cleared
inspectors may obtain, copy, view, or collect CBI materials. If the
establishment-facility is inspected by an authorized State inspector,
using State credentials, any CBI information/documents in
question must be: (1) only provided to the State inspector on a
consensual or voluntary basis and only after the State inspector has
informed the establishment they are cleared to view, obtain, or
copy CBI under State statute or (2) if claimed FIFRA CBI, request
the responsible company official to send the
information/documents directly to the EPA Regional FIFRA
Document Control Officer (DCO). The inspector must provide the
responsible company official with a listing of all requested
documents/exhibits to be sent to the regional office, and notify the
Regional DCO that the company is sending the information.
Pre-inspection Activities (Regional Office Function)
The Federal EPA inspector should conduct the following pre-
inspection activities:
*• Review and copy section 7 pesticide establishment
production data submitted to the region on EPA Form
3540-16 for all unregistered products exported for the
targeted calendar year(s).
*• Develop a comprehensive list of unregistered products
exported in the targeted calendar year(s) by the targeted
establishment. Regional listings of unregistered products,
product name and establishment name/address should be
obtained from the Section Seven Tracking System (SSTS).
*• Review and copy all "confidential statements of formula"
(CSF) or chemical formulation statements if available at the
region for all products identified above. Develop a list of all
unregistered products that were found not to have "product
formulas" on file and give it to the regional/State inspector
prior to the inspection (so that the inspector can obtain any
missing formulas at the time of the inspection). Note on this
listing if "product formulas" were not submitted to the
region along with the production data in EPA Form 3540-16
for each calendar year.
On-Site Inspection Activities (Regional/State Function)
Entry
Present credentials and issue a Notice of Inspection to the agent-in-
charge. The reason for the inspection must be stated and, if a
violation is suspected, and the suspected violation must be noted in
writing on the Notice of Inspection.
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For each unregistered product exported in the targeted calendar
year(s), the inspector must:
* Obtain evidence that clearly shows the company responsible
for the product and its export. Obtain evidence that
describes past and present corporate relationships, such as
mergers, takeovers and/or other corporate transactions and
any agreement expressing the nature and responsibilities
between the companies involved in the export of the
pesticide/device.
*• Obtain copies of the "confidential statement of formula"
(CSF) if available; otherwise, obtain a copy of the complete
formula of the product. (Note: The CSF contains confidential
business information (CBI) and cannot be viewed, copied, or
obtained by a State inspector unless authorized by statute
and State credentials. An EPA inspector cannot view/copy
the CSF unless cleared for CBI).
* Obtain copies of the specifications or directions of the
foreign purchaser for the production of the product [40 CFR
Partl69.2(h)(l)].
* Obtain copies of label(s) and supplemental labeling,
including bilingual label(s), used for each importing country
[40 CFR Part 169.2(h)(2)]. If product label(s)/labeling are not
available, obtain bin labels/labeling. In either case, the
inspector shall obtain a statement from the responsible
company official certifying that the labels/labeling collected
are identical to those used on the exported product.
* If a particular product label is being used for more than one
country, the statement must include the name of each
country. If unregistered pesticides are packaged, labeled
and released for shipment at the time of the inspection,
obtain sample labels/labeling and photographic evidence of
all such products.
* Obtain copies of all foreign purchaser acknowledgment
statements for the first shipment each year of a particular
product to a particular purchaser for each importing country
[40CFRPartl69.2(h)(3)].
* Obtain documentation showing the dates and amounts of
each unregistered product shipped and country of
destination, (e.g. bills of lading, invoices, consignee lists) [40
CFR Part 169.2(d)]. Only federal EPA inspectors or
authorized State/tribal inspectors using State or tribal
credentials and State or tribal authority can obtain this
documentation.
* Note in the inspection report/findings if any of the
documents above were not maintained by the facility. If the
facility does not maintain records listed above, obtain a
statement from the responsible official as to why the records
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were not maintained by the facility and the actual location of
the records/documents, if known. The inspector must
request that copies of all missing records be sent to the
inspector or at a minimum to the Regional office.
*• In instances where the facility/establishment claims that a
product is "substantially similar" to a registered product and
a foreign purchaser acknowledgment statement was
therefore not required.
• Obtain a statement from the responsible company official
certifying that the unregistered product is "substantially
similar in composition and use" to one or more federally
EPA registered products, and specifically list each
registered product(s) that the company claims as similar to
its unregistered product by product name and EPA Reg.
No.(s) along with the rationale for making such a claim.
*• For instances where the facility/establishment claims that a
product is for "research and development" or
"experimental" purposes and a foreign purchaser
acknowledgment statement was therefore not required.
• Obtain a statement from the responsible company official
specifically describing the basis for any such claims.
The FIFRA export inspection checklist (Exhibit 14-2) will assist the
inspector covering all the above items.
Imports
Imported pesticides and devices are subject to the same
registration, labeling requirements, and exemptions as domestically
produced pesticides and devices.
Import of Unregistered Pesticides
Under certain conditions, unregistered pesticides will be allowed to
enter the United States. A Notice of Arrival of Pesticides and
Devices (NOA), EPA Form 3540-1 will be required for these
unregistered products. These conditions are found in 40 CFR
152.30 and in Pesticide Registration (PR) Notice 99-1 (Exhibit 14-
3). An unregistered pesticide may be imported if:
(1) it is transferred between registered establishments operated by
the same producer (all EPA label requirements must be met;
(2) if the establishments are not operated by the same producer
refer to 40 CFR Part 152.30 for additional requirements);
(3) distributed for use in an experimental use permit;
(4) distributed for use under an emergency exemption;
(5) or import is solely for the purpose of formulation or packaging
for subsequent export provided certain requirements are met (see
PR Notice 99-1, Exhibit 14-3).
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Import of Pesticides That Are Exempt From FIFRA Regulations
Substances or mixtures of substances that are being put through
laboratory, greenhouse or small scale field tests to determine
pesticidal activity are substances with pesticidal characteristics and
must enter the U.S. in accordance with statutory and regulatory
requirements pursuant to Section 17(c) - there is no exemption
from FIFRA import requirements for pesticidal test
substances. Pesticides and pesticidal substances used in research
and development are still pesticides and regulated by Section 17(c)
and 19 CFR Part 12.110 through 12.117 (see Exhibit 14-5).
Substances are either regulated by FIFRA, TSCA or FFDCA. If
the substance is characterized as a pesticidal chemical, then it is
regulated under FIFRA. If the substance is characterized as a
pharmaceutical chemical, then it is regulated under FFDCA. If the
substance is neither pesticidal or pharmaceutical, then it is regulated
under TSCA. Only TSCA exempts TSCA regulated R&D
chemicals from the import requirements of the TSCA statute and
regulations. FIFRA does not exempt pesticidal R&D chemicals
from the import requirements for the Act and regulations.
Import of Registered Pesticides and Devices
Before pesticides or devices can be imported into the United States,
the importer must submit a NOA of Pesticides and Devices, EPA
Form 3540-1 (see Exhibit 14-4) prior to the arrival of the shipment
in the United States. The EPA Regional office shall:
* Complete Part II of the NOA, indicating the disposition to be
made of the shipment of pesticides or devices upon its
arrival in the United States.
* Return the completed NOA to the importer or its agent.
Normally, an import broker will represent the importer in obtaining
EPA and U.S. Customs clearance.
Upon the arrival of a shipment of pesticides or devices, the
importer (or broker) shall present to the U.S. Customs at the port
of entry the NOA completed by the EPA Regional office indicating
the appropriate Customs action to be taken with respect to the
shipment.
Regional Office
The Regional office supervisor/import coordinator and pesticide
inspectors should maintain a cooperative working relationship with
the U.S. Customs Service and customs brokers. This is vital to
understanding the way each different Port of Entry conducts its
business. Upon receipt of the NOA, the Regional office should
review the NOA for completeness and determine whether to
inspect and/or sample based on the following:
* Pesticides/devices suspected of noncompliance (e.g.,
unregistered pesticides and/or unregistered establishment).
*• Pesticides/devices with a violative history (the Region may
have knowledge of a violative product or company).
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* First-time import of a pesticide/device to the Region.
* Pesticides/devices imported regularly with a good history of
compliance (i.e., high volumes).
If a decision is made to inspect the imported pesticide/device, Part
II of the NOA will indicate what action to take. The options are:
* Detention of the pesticides/devices by Customs for
inspection by EPA. The expenses associated with the
detention must be borne by the importer. It is important that
the inspection be conducted as soon as possible since the fate
of the shipment is determined by the inspection. This type
of inspection is likely to occur at the Port of Entry as the
shipment is not usually released to the importer until
compliance is determined by EPA. The shipment may have
been picked up by the consignee under an Immediate
Delivery entry (usually an electronic entry) (19 CFR Part
142.21-142.22; Exhibit 14-12). In such cases, the shipping
company or the import broker should be requested to locate
and hold the product for inspection.
* Release of the shipment of pesticides/devices under Bond.
In accordance with section 17(c) of FIFRA, EPA may instruct
Customs to release a shipment of pesticides/devices under a
Bond for the return of the imports to the custody of
Customs. When this option is chosen the shipment is
technically being detained because the pesticides/devices
cannot be used or otherwise disposed of until EPA conducts
an inspection and makes a determination. This type of
inspection will take place at the consignee's facility and must
proceed following normal protocol for establishment
inspections. Whenever circumstances permit, EPA should
consult with Customs personnel at the Port of Entry to
ensure that the bond set by Customs [(see Exhibit 14-11) 19
CFR 113.61 and 113.62] is of an amount significant enough to
compel the importer to hold the shipment for inspection.
Circumstances such as prior knowledge of the quantity
and/or estimated value of the shipment as well as the status
of the cooperative working relationship between EPA and
Customs personnel at the Port of Entry will dictate the
feasibility of such a consultation. In special circumstances
where concern exists that a bond may not stop distribution
of the products, the EPA Regional office should consider
issuing a Stop Sale, Use, or Removal Order (SSURO).
If the EPA Regional office instructs Customs to either detain the
imported pesticides/devices, or to release the shipment under a
bond, an EPA inspector must be prepared to conduct an
inspection. Documentary Samples of labels and/or pesticides can
be taken to determine compliance with FIFRA.
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The location of detained pesticide import shipments is determined
by the U.S. Customs Service and carried out by the import broker.
The location will be a U.S. Customs licensed and bonded
warehouse operated by private storage/warehouse company.
Customs
The U.S. Customs regulations governing the procedure for
pesticide imports are located in 19 CFR Part 12 (Exhibit 14-10).
Although these are helpful guidelines, these procedures are not
standardized. Nothing can replace a cooperative working
relationship with Customs and customs brokers, as each Port of
Entry may follow a somewhat different protocol. Some Customs
offices will not allow inspections to take place at the Port,
sometimes even the bond placed on a shipment might have a
different meaning depending on the Port. This makes it crucial
that the Regional office and the inspectors maintain a close
relationship with Customs to keep up with these various
differences.
Inspections and Sampling
Imported pesticides/devices can be inspected at different Ports of
Entry or other locations depending on how the shipment arrived in
the United States and the U.S. Customs status of the shipment.
Upon arrival at the inspection site, the inspector must introduce
himself/herself, present federal credentials (as all import
inspections are conducted under section 8 and 9 of FIFRA),
explain the purpose of the inspection and issue a Notice of
Inspection (EPA Form 3540-2) with the reason for inspection.
The Notice of Inspection must be issued to the person who has
control of the product at the time of the inspection. The U.S.
Customs Service never takes custody of the product during the
importation/entry of the shipment. A Notice of Inspection is
issued to the importer, import broker, bonded warehouse owner, or
shipper of the import.
Import Sampling
Physical samples should be collected if EPA suspects that the
pesticide product has been adulterated or suspects that the
composition of the pesticide product is different from the
Confidential Statement of Formula (CSF) in connection with the
registration of the product. For all other suspected or observed
violations, documentary samples are sufficient to demonstrate a
violation of FIFRA and provide sufficient weight of evidence to
instruct the U.S. Customs Service to refuse entry of the import
shipment. Documentary samples will always include photographs
of the label and labeling on the pesticide containers in the import
shipment. There will never be any "bin labels" or other items to
collect as documentary samples of the pesticide product.
The inspector must take the following steps when obtaining
physical samples:
* Issue a Receipt for Samples for any samples taken.
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* Submit the sample to the appropriate laboratory and ask the
laboratory to expedite the analysis.
*• Inform the supervisor/import coordinator that a sample has
been collected and sent for analysis.
Following a sample collection, and while waiting for chemical
analysis or case review, the pesticide will have to be detained. The
location where the pesticide is held must be determined by the
import broker and U.S. Customs agent. The shipment must be
kept intact until EPA makes a determination of compliance.
Inspection Without Sampling
When conducting an inspection without sampling, the inspector
must complete the following steps:
*• Review the labeling for mandatory label requirements. Prior
to inspection of detained shipments, a copy of the label
should be obtained from the Product Manager (PM) in the
Office of Pesticide Programs (OPP), or from the Pesticide
Product Labeling System (PPLS) at:
http://www.epa.gov/pesticides/pestlabels
* Check for collateral labeling such as books, pamphlets.
*• Check condition of the lot.
If a label or labeling violation is noted, the inspector must
photograph or photocopy the label for documentary evidence (see
Chapter 9 for more information on sampling procedures).
Regional Office Procedure After Inspection
Merchandise Complying With the Act
If the imported pesticide/device is found to be in compliance with
Act, the Regional office must notify the U.S. Customs Service that
the shipment may be released to the consignee.
One way to standardize the way Regions notify Customs that the
shipment may be released may be to "CC" the District Director of
Customs at the Port of Entry on a "Release Notice" addressed to
the importer of record. For purposes of expediting the notice,
EPA Regional personnel should fax a copy of the release notice to
their Customs staff counterpart at the Port of Entry. A Model
Release Notice is included as Exhibit 14-7.
Merchandise Not Complying With the Act
If the imported pesticide/device is found to be in violation of the
Act, the Regional office must refuse admission of the
pesticides /devices into the country. Notification of this refusal
must be made by EPA to the consignee. This procedure is
consistent with the Customs Regulation in 19 CFR 12.117(b) (See
Exhibit 14-9 for a Notice of Detention and Hearing). The
consignee is given 20 days to submit written material, or at the
option of the consignee, appear before EPA and introduce
testimony to show cause why the shipment must not be destroyed
or refused entry. If no hearing is requested or, after consideration
of the evidence, it is still the opinion of EPA that the shipment is in
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violation of FIFRA, the importer has 90 days from the date of
receipt of the "Notice of Refusal of Admission" to export the
violative products. One way to standardize the way Regions notify
Customs that the shipment has been refused admission may be to
"CC" the District Director of Customs at the Port of Entry on a
"Notice of Refusal of Admission" addressed to the importer of
record. For purposes of expediting the notice, EPA Regional
personnel should fax a copy of the release notice to their Customs
staff counterpart at the Port of Entry. A model "Notice of Refusal
of Admission" is found at Exhibit 14-8. If this does not occur, the
U.S. Customs Service in cooperation with EPA may oversee the
destruction of the pesticides/devices; although this is done as last
resort because of the expense to the U.S. Customs Service and the
public.
Possible violations of FIFRA can include any of the unlawful acts
described in sections 12(a)(l), 12(a)(2)(M), and 12(a)(2)(N) of
FIFRA. These include but are not limited to, distribution of an
unregistered pesticide, distribution of a misbranded or an
adulterated pesticide, and failure to file reports required be the Act.
Stop Sale Orders and Seizures under section 13 of FIFRA can be
issued for imports suspected of being in violation of the Act. Note:
there is always an importer of record for every import shipment,
and it is this person who is held liable for any violations. Import
brokers only act as agents of the importer of record and become
jointly liable if a violative product is found to be distributed
(imported) into the U.S.
A FIFRA import inspection checklist (Exhibit 14-6) will assist the
inspector covering all the above items.
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Exhibit 14-1
Environmental Protection Agency
168.75 Procedures for exporting unregistered pesticides-
purchaser acknowledgement statements.
168.85 Other export requirements.
AUTHORITY: 7U.S.C. 136-136y.
SOURCE: 54 FR 1125, Jan. 11, 1989.
Subpart A—General Provisions
[Reserved]
Subpart B—Advertising
§168.22 Advertising of unregistered pesticides,
unregistered uses of registered pesticides and
FIFRA section 24(c) registrations.
(a) FIFRA sections 12(a)(l) (A) and (B)
make it unlawful for any person to "offer for
sale" any pesticide if it is unregistered, or if
claims made for it as part of its distribution or
sale differ substantially from any claim made
for it as part of the statement required in
connection with its registration under FIFRA
section 3. EPA interprets these provisions as
extending to advertisements in any advertising
medium to which pesticide users or the general
public have access.
(b) EPA regards it as unlawful for any person
who distributes, sells, offers for sale, holds for
sale, ships, delivers for shipment, or receives
and (having so received) delivers or offers to
deliver any pesticide, to place or sponsor
advertisements which recommend or suggest
the purchase or use of:
(1) Any pesticide for a use authorized under
a FIFRA section 5 experimental use permit
(EUP).
(2) Any pesticide for a use authorized under
a FIFRA section 18 emergency exemption,
except for advertisements that:
(i) Are placed in media which address
primarily persons in the geographical area to
which the exemption applies.
(ii) State the name and address of one or more
retail dealers who stock the pesticide.
(iii) Contain a prominent notice of the
limitations on use under the section 18
emergency exemption.
(3) Any pesticide for any use authorized only
by a FIFRA section 24(c) special local need
registration, unless the advertisement contains
a prominent notice of the limitations on use
under the section 24(c) registrations
§168.65
(4) Any unregistered pesticide for any use
unless the advertisement is one permitted by
paragraph (b) (2) or (3) of this section.
(5) A registered pesticide product for an
unregistered use, unless the advertisement is
one permitted by paragraph (b) (2) or (3) of this
section. However, as a matter of policy, the
Agency will not regard as unlawful the
advertisement of uses permitted by FIFRA
section 2(ee) provided the product is not an
antimicrobial pesticide targeted against human
pathogens (see 51 FR 19174; May 28, 1986).
(c) For purposes of paragraph (b) of this
section, a "prominent notice of the limitations
on use" is one which sets forth the limitations
on use in a manner reasonably likely to be
understood by persons to whom the
advertisement is addressed. For printed
advertising, this criterion will be met by a
legend in 6-point or larger type.
Subpart C [Reserved]
Subpart D—Export Policy and
Procedures for Exporting
Unregistered Pesticides
SOURCE: 58 FR 9085, Feb. 18, 1993, unless otherwise noted.
§168.65 Pesticide export label and labeling
requirements.
(a) General. This section describes how EPA
interprets and will enforce the requirements of
FIFRA section 17(a)(l). Every exported
pesticide, device, and active ingredient used in
producing a pesticide (see § 152.3 of this
chapter for the definition of "active
ingredient" and "pesticide") must bear a label
or labeling which meets the requirements of
FIFRA section 17(a)(l). This requirement
applies to all such pesticides, devices, or active
ingredients, regardless of whether the export is
for commercial or research use. In the case of
unregistered pesticides, including research
substances which are being exported for
testing, the labeling requirements of this section
continue to apply independently of whether the
exporter must submit a purchaser
acknowledgement statement under FIFRA
section 17(a)(2) as described at §168.75 of this
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§ 168.65
chapter. In addition, information which will
satisfy FIFRA section 2(q)(l)(E), (G), and (H)
and section 2(q)(2)(A) and (D) must appear in
English and in the appropriate foreign
languages, on the label or labeling as described
in paragraph (b)(4) of this section. The required
label and labeling statements may be met
through either immediate container labels,
accompanying supplemental labeling as
described in paragraph (c) of this section, or a
combination of the two.
(b) Specific requirements. The labels and
labeling of any exported pesticides, devices,
and active ingredients used in producing
pesticides must meet the requirements
regarding label and labeling content, correct
representation, and understandability as stated
in this paragraph.
(1) Label contents. The term label means the
written, printed, or graphic matter on or
attached to the immediate container of the
pesticide, device, or active ingredient used in
producing a pesticide. In the case that the
immediate container is enclosed in an outer
container or wrapper through which the label
cannot be read, the label must also be on such
outer container or wrapper. Except as provided
in paragraph (c) of this section, the immediate
container of the pesticide, device, or active
ingredient used in producing a pesticide must
bear a conspicuous and readable label which
includes:
(i) EPA pesticide producing establishment
number. The producing establishment
registration number must be present but may
appear anywhere on the label or immediate
container in accordance with the establishment
registration labeling requirements set forth in §
156.10(1) of this chapter.
(ii) Warning or caution statements. Warning
or caution statements must appear on the label
and must be adequate for the protection of
persons handlingthe pesticide, device, oractive
ingredients including warnings regarding
general toxicological hazards and
environmental, physical, or chemical hazards.
Warning and caution statements must appear in
English and in the appropriate foreign
languages, as described in paragraph (b)(4) of
this section. Where the U.S. warning or caution
statement, as translated, is obviously
inappropriate to protect residents of the
importing country, (for example, where a
statement calls for a gas mask meeting the
FIFRA Inspection Manual, February 2002
40 CFR Ch. I (7-1-00 Edition)
specification of the U.S. Bureau of Mines) an
equivalent caution must be substituted.
(iii) The statement' 'Not Registered for Use in
the United States of America.'' The labels of all
pesticides, devices, and active ingredients
which are not registered for use in the United
States under FIFRA section 3 must prominently
display the following statement: "Not
Registered for Use in the United States of
America." The statement must appear in
English and in appropriate foreign languages,
as described in paragraph (b)(4) of this section.
It is permissible to append explanatory text
which qualifies the statement by pointing out
the reasons for the unregistered status.
Examples of possible additional statements are
"Not Registered for Use on...", "No Longer
Registered for Use...", or "Not Registered...
because..." Such additions must not be
misleading or misrepresent the registration
status of the pesticide. The statement "Not
Registered For Use in the United States of
America'' must also be present.
(A) A pesticide is considered registered for
the purposes of the section 17(a)(l)
requirement only when:
(1) A label and labeling approved under a
current FIFRA section 3 registration for the
product is either attached to the immediate
product container or accompanies the product
at all times as supplemental labeling as
provided in paragraph (c) of this section.
(2) The formula of the exported product is the
same as the formula of the U.S. registered
product (within certified limits). In addition, a
change in the color or fragrance of the export
product will not affect the product' s registration
status, as long as the following conditions are
met:
(/') The change in color must result only from
the addition of a dye included on the list of the
chemicals exempted from the requirement of a
tolerance at § 180.1001, and the dye must not
be a List 1 inert. (List 1 inerts are those inerts
which the Agency has identified as presenting
toxicological concerns. The classification of
inerts is explained in EPA's Policy Statement
on Inert Ingredients in Pesticide Products,
which can be obtained from the Office of
Pesticide Programs public docket, Room 1128,
Crystal Mall 2,1921 Jefferson Davis Highway,
Arlington, Virginia 22202.)
(ii) The change in fragrance must result
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Environmental Protection Agency
only from the addition of a chemical included
on the list of chemicals exempted from the
requirement of a tolerance (§ 180.1001) and the
chemical must not be a List 1 inert.
(Hi) The change in fragrance must not result
in a pesticide product containing a food or
food-like fragrance. (See "Food Fragrances in
Pesticide Formulations," EPA's Office of
Pesticide Programs Policy and Criteria Notice
number 2155.1, November 20,1975 which can
be obtained from the Office of Pesticide
Programs public docket, Room 1128, Crystal
Mall 2, 1921 Jefferson Davis Highway,
Arlington, Virginia 22202.).
(iv) Any differences in color or fragrance of
the export product in accordance with this
section must be reflected in records which
show the complete formula of the export
product in accordance with the requirements of
§ 169.2 and this policy.
(3) No statements which appear on any of the
product labels or labeling add new uses or
claims or in any way contradict the approved
FIFRA section 3 labeling. However, certain
minor changes may be made to a product's
labeling or packaging without affecting the
registration status of the product, as specified in
§ 152.46(b) of this chapter.
(iv) The ingredient statement. The ingredient
statement must appear on the label in English
and in appropriate foreign languages (as
described in paragraph (b)(4) of this section). If
the English language description of the
ingredients is easily identifiable and likely to be
understood by the ordinary individual, the
foreign language ingredient statement need not
be included on the label. In the case of
pesticide products, devices and active
ingredients shipped solely for research and
development purposes, it is permissible to use
coded identification of ingredients on the label
in order to protect confidentiality, in
accordance with the requirements of
§§168.75(c)andl68.85(a).
(v) Identity of parties. The name and address
of the producer, registrant (if any), or the
person for whom the pesticide was produced,
must appear on the label.
(vi) Weight or measure. The net weight must
appear on the label in either English or metric
units.
(vii) Additional warning for highly toxic
pesticides. If the pesticide, device or active
§168.65
ingredient is highly toxic to humans, the skull
and crossbones, the word "Poison", and a
statement of practical treatment must appear on
the label. The word "Poison" and the
statement of practical treatment shall be in
English and in the appropriate foreign
languages, as described in paragraph (b)(4) of
this section. The skull and crossbones may be
in red or black. For criteria on what pesticides
are highly toxic, see § 156.10(h) of this chapter.
(2) Use classification statement. In addition
to the label contents described in paragraph
(b)(l) of this section, the labeling must include
a use classification statement, if a use
classification has been assigned under a FIFRA
section 3 registration. The use classification
shall accurately describe the use classification
applicable to the U.S. registered use of the
pesticide, device or active ingredient (e.g.,
"Restricted Use Pesticide"). Summary
statements describing the use classification,
e.g., "For retail sale to and use only by
Certified Applicators...", or explaining what
such terms mean are not required, but may be
included if such statements do not result in
false representation of the U.S. regulatory
status of the pesticide. The use classification
information may appear on the product label or
on the labeling accompanying the pesticide
product during shipment.
(3) Misrepresentation. The labeling shall not
make false or misleading representations or
represent the product as an imitation of other
products.
(4) Understandability. The required
statements must be expressed in such terms as
to render them likely to be read and understood
by the ordinary individual under customary
conditions of purchase and use. To satisfy this
section, certain information described in
paragraph (b)(4)(i) of this section, which
appears on the labeling of all exported pesticide
products, devices and active ingredients must
appear in English, in an acceptable language of
the country of import as defined in paragraph
(b)(4)(ii) of this section, and in an acceptable
language of the country of final destination, if
known or reasonably ascertainable by the
exporter. When there are several official
languages or dialects in a country, the language
which is predominately spoken or written, or a
language inwhichofficial government business
is conducted, will be acceptable.
Chapter Fourteen • Pesticide Import & Export Program • 14-14
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§168.75
(i) Information required to be multilingual.
The following labeling information must be
multilingual:
(A) The warning and caution statements.
(B) Where required, the statement "Not
Registered for Use in the United States of
America.''
(C) The ingredient statement.
(D) Where required in accordance with
paragraph (b)(l)(vii) of this section, the word
"Poison" and the statement of practical
treatment in case of poisoning.
(ii) Acceptable languages. In all cases,
English must be one of the languages used on
the label or labeling. In addition, either the
language which is used to conduct official
government business, or the predominantly
spoken or written language of the country of
import must appear on the labeling. In each
case where a country of final destination is
known, the language which is used to conduct
official government business or which is
predominantly spoken in that country, if
different from the language of the country of
import, shall also appear on the labeling. In any
case where English is predominantly spoken or
written or is the language used to conduct
official government business in a country, no
other language need be included to meet the
multiple language requirement of this
paragraph.
(c) Supplemental labeling. A pesticide, device
or active ingredient intended for export will not
be considered in violation of the labeling
requirements of FIFRA when the label and/or
labeling requirements stated in paragraph (b) of
this section are met by supplemental labeling.
Supplemental labeling must be attached to the
immediate product container or the shipping
container of the pesticide, device or active
ingredient at all times when it is shipped or
held for shipment to meet export label
requirements. Supplemental labeling must meet
all of the label requirements in paragraph (b) of
this section which are not met by the immediate
product labels. Supplemental labeling will
satisfy the labeling requirements of FIFRA only
if the following conditions are met:
(1) Applicability. The use of supplemental
labeling applies to any situation where the
labeling requirements specified in this section
are not met fully on the product label which is
attached to the immediate product container.
Any required label or labeling statement not
FIFRA Inspection Manual, February 2002
40 CFR Ch. I (7-1-00 Edition)
met on the immediate container may be met
through supplemental labeling.
(2) Labeling contents and relation to
shipment. If supplemental labeling is used to
meet any of the labeling requirements of
FIFRA section 17(a)(l), it must meet all of the
requirements in paragraph (b) of this section
which are not met by the label on the
immediate product container. Thus, the
supplemental labeling, together with the
immediate product container label will meet all
of the requirements of paragraph (b) of this
section. Where used, supplemental labeling
must be attached to or accompany the product
shipping container of the pesticide, device, or
active ingredient used in producing a pesticide
at all times when shipped or held for shipment
in the United States.
§168.75 Procedures for exporting unregistered
pesticides—purchaser acknowledgement
statements.
This section describes how EPA interprets
and will enforce requirements of FIFRA section
17(a)(2). Section 17(a)(2) provides that any
person exporting a pesticide other than a
pesticide registered for use under FIFRA
section 3 or sold under FIFRA section 6(a)(l),
shall obtain a statement signed by the foreign
purchaser prior to export, acknowledging that
the purchaser understands that such pesticide is
not registered for use in the United States and
cannot be sold in the United States. Section
17(a)(2) requires that a copy of the statement be
transmitted to an appropriate official of the
government of the importing country.
(a) Products subject to the requirement. EPA
will not consider an exporter of an unregistered
pesticide to be in violation of FIFRA section
17(a)(2) if, prior to export of the pesticide, the
exporter submits to EPA a statement signed by
the foreign purchaser which affirms that the
purchaser is aware that the pesticide is not
registered for use in the United States and
cannot be sold for use in the United States. The
exporter must also include with the submission
of the purchaser acknowledgment statement to
EPA, a certification signed by the exporter
affirming that the export did not occur until the
statement signed by the foreign purchaser was
obtained by the exporter. Except as provided in
paragraph (b) of this section, all pesticide
products produced for export which cannot be
sold for use in the United States in the form that
they are produced for export, are considered to
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be unregistered pesticides. This includes
pesticides which are of a different formulation,
including composition (except for variation
within certified limits), or type of formulation,
and pesticides which are packaged for use
patterns for which they are not registered,
which may be evidenced by package type or
label use statements. This also includes
unregistered products which are under
development as pesticidal products and which
are being exported for research testing.
(b) Exceptions. Under the specific
circumstances discussed below, EPA will not
treat a registered product which has been
modified slightly for export purposes, as
unregistered for the purposes of the purchaser
acknowledgment statement requirement. Any
changes to the registered product for export
purposes must be documented in accordance
with the record-keeping requirements at §
169.2 of this chapter and this policy.
(1) Labeling on Immediate Product. EPA will
not treat as unregistered for the purposes of
section 17(a)(2), a registered pesticide product
which cannot be sold or distributed for use in
the United States because its immediate product
container does not bear a label approved under
a FIFRA section 3 registration, but which could
be sold or distributed in the United States with
the approved label attached to the immediate
product container, provided that the label and
labeling approved under a current FIFRA
section 3 registration for the product is either
attached to the immediate product container or
accompanies the product at all times as
supplemental labeling as provided in paragraph
(c) of this section.
(2) Packaging, (i) Certain changes may be
made to a product's labeling or packaging
without affecting the registration status of the
product, as specified in § 152.46(b) of this
chapter and this policy. These changes include
any changes in package size and label net
contents, provided no change in use directions
or requirement for child-resistant packaging
would be necessary for the product to be
registered for use in the United States. For
example, if child-resistant packaging is
required for a particular pesticide product in the
United States, and the product will be exported
without child-resistant packaging, the product
would be considered unregistered and therefore
subject to all the requirements of FIFRA
section 17(a), as described in § 168.75 of this
§168.75
chapter including the requirement for a
purchaser acknowledgment statement.
(ii) If an exporter needed to repackage a
product in a size to meet a foreign purchaser's
specifications, that modification would not
affect the registration status of the export
product. Other modifications to the label used
for export purposes which will not affect the
export product's registration status are: the use
of metric units for net contents, dosages, and
other numeric expressions; the use of a
different format for the label, provided that the
information does not contradict the U.S. label;
revision of nonmandatory U.S. label
statements, consistent with 40 CFR part 156,
including additions or changes required by
other Federal statutes or regulations; a change
of the name or address of the registrant, except
for a change resulting from transfer of
ownership, which requires that a registrant keep
his name and address current with the Agency;
and any correction of typographical or printing
errors that appeared on the U.S. labeling. (See
§ 152.46(b)).
(3) Labeling statements. The following
statements which appear on any of the product
labels or labeling will not affect the status of
the product, provided that they do not
contradict the approved FIFRA section 3
labeling:
(i) It is permissible to add explanatory language
which accurately explains the meaning of a use
classification. For example, the statement
' 'restricted use pesticide'' may be expanded to
read: "Restricted in the United States of
America to use by certified applicators" or
"Restricted Use Pesticide. In The United States
this product is restricted to use by applicators
determined by each state to be competent in
pesticide application and the human health and
environmental consequences of misuse.'' If the
explanatory language falsely represents or is
misleading regarding the U.S. use
classification, the product will be considered
misbranded. In addition, a use classification can
only be listed if one has been assigned pursuant
to the U.S. registration.
(ii) An exporter who is also the manufacturer
of aU.S. registered pesticide may add new uses
to the label of that product for export purposes,
without triggering the requirements of section
17(a)(2), as long as the new uses are within the
same general use patterns as those for the
registered product. (Pesticide use patterns are
Chapter Fourteen • Pesticide Import & Export Program • 14-16
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§168.75
listed in appendix A to 40 CFR part 158—Data
Requirements for Registration: Use Pattern
Index. The general pesticide use patterns are:
terrestrial food crop and terrestrial nonfood
crop; greenhouse food crop and greenhouse
nonfood crop; aquatic food crop and aquatic
nonfood crop; indoor use; and forestry use.)
Adding new uses to the label which change the
use pattern, such as changes from non-food to
food use, outdoor to indoor use, or terrestrial to
aquatic use, render the product unregistered and
subject to the requirements of section 17 for
unregistered products. If the new use added to
the label is a food or feed use, a tolerance must
already be established for the use of that
pesticide in or on that commodity.
(4) Composition. EPA will not treat a
registered product as unregistered for the
purposes of the purchaser acknowledgment
statement requirement under the following
specific circumstances:
(i) The formula of the exported product is
within certified limits of the formula of the U.S.
registered product.
(ii) An exporter, who is also the manufacturer
of a U.S. registered pesticide, may decrease the
percentage of the active ingredient(s) of that
product by adding a List 4 inert ingredient,
without causing the product to be treated as
' 'unregistered'' and triggering the requirement
to obtain a purchaser acknowledgment
statement as a condition for export. In EPA's
Policy Statement on Inert Ingredients in
Pesticide Products, EPA included inert
ingredients on List 4-a list of inert ingredients
posing minimal hazard or risk-if the inert
ingredients were generally regarded as
innocuous. The provisions of this paragraph do
not apply to those pesticide products intended
for public health uses which are required or
conditionally required to submit efficacy data
pursuant to § 158.640 of this chapter. Any
differences in formula or composition caused
by adding a List 4 inert must be reflected in
records which show the complete formula of
the export product in accordance with the
requirements of § 169.2 and this policy.
(iii) A change in the color or fragrance of the
export product will not affect the product's
registration status as long as the following
conditions are met. The change in color must
result only from the addition of a dye included
on the list of the chemicals exempted from the
requirement of a tolerance at § 180.1001, and
the dye must not be a List 1 inert. (List 1 inerts
FIFRA Inspection Manual, February 2002
40 CFR Ch. I (7-1-00 Edition]
are those inerts which the Agency has
identified as presenting lexicological concerns.
The classification of inerts is explained in
EPA's Policy Statement on Inert Ingredients in
Pesticide Products. The change in fragrance
must result only from the addition of a
chemical included on the list of chemicals
exempted from the requirement of a tolerance
(§ 180.1001) and the chemical must not be a
List 1 inert. The change in fragrance must not
result in a pesticide product containing a food
or food-like fragrance. (See ' 'Food Fragrances
in Pesticide Formulations," EPA's Office of
Pesticide Programs Policy and Criteria Notice
number 2155.1, November 20, 1975.) Any
difference in color or fragrance of the export
product in accordance with this section must be
reflected in records which show the complete
formula of the export product in accordance
with the requirements of § 169.2 and this
policy.
(5) Research and development products. An
unregistered pesticide product exported only
for research and development purposes is
subject to the notification requirements of this
section, unless its use fits within the criteria
described in this paragraph.
(i) An unregistered pesticide product
exported solely for research and development
purposes will not be considered to be in
violation of the notification requirements if the
export of the research and development
product:
(A) Would not involve land uses of more than
10 acres (4.05 hectares), or be used on or affect
food or feed crops which are intended for
consumption.
(B) Would not involve aquatic uses of more
than 1 acre (0.405 hectares), or any aquatic
uses which involve water used for irrigation,
drinking or recreation, or be used on or affect
plants or animals taken for food or feed from
such waters.
(C) Would not involve tests on animals
intended for food or feed
(ii) Shipments to different purchasers, to
different countries of final destination, or which
occur more than a calendar year apart will be
evaluated separately. When determining
whether total shipments exceed the criteria
described in this paragraph, EPA will evaluate
the total amount of shipments by a single
exporter during a calendar year for use in a
particular country.
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Environmental Protection Agency
(iii) An exporter bears the burden of
demonstrating that the product meets these
criteria before
the research product is shipped. This may be
met by documenting before the product is
shipped and maintaining records for the time
period required by § 169.2(h) of this chapter
from the date of the last shipment relevant to
such records. The records to be maintained
consist of:
(A) The identity of the purchaser and country
of intended use of the research product.
(B) The amount shipped.
(C) The intended research use by the
purchaser, including the type of application
site, rate of application, and measures taken for
protection of humans from direct or dietary
exposure.
(c) Procedures. An exporter of an
unregistered pesticide product must submit a
purchaser acknowledgment statement to EPA
containing the information stated in paragraph
(c)(l) of this section, and a statement signed by
the exporter certifying that the exportation did
not occur until the signed acknowledgment
statement had been obtained from the
purchaser. If the foreign purchaser signs a
purchaser acknowledgment statement in their
own language, it must be accompanied by an
English translation when it is submitted to EPA
by the exporter. These statements shall be
submitted in accordance with one of the two
options for submission described in paragraph
(c)(2) of this section.
(1) Contents of the purchaser
acknowledgment statements. The purchaser
acknowledgment statement must include the
following information in a format that is clearly
understandable:
(i) Name, address, and EPA identification
number, if applicable, of the exporter.
(ii) Name and address of the foreign
purchaser.
(iii) Identity of the product and the active
ingredient(s), including:
(A) The Chemical Abstract Services (CAS)
Registry number for each active ingredient.
(B) The chemical nomenclature for each
active ingredient as used by the International
Union of Pure and Applied Chemists (IUPAC).
(C) Other known chemical or common
names; or if the export involves a research
product, a code name or identification number
that can be used by EPA to identify the product
from the exporter's records. If a code name or
§168.75
identification number is used, additional
information must be attached to the
certification statement submitted with the
purchaser acknowledgment statement which
will enable EPA to identify the product. This
attached information may be claimed as
confidential, and EPA will not forward this
information with the purchaser
acknowledgment statement to foreign
governments.
(iv) If known or reasonably ascertainable, the
country or countries of final destination of the
export shipment, i.e., where the exported
pesticide is intended to be used, if different
from the country of the foreign purchaser's
address.
(v) A statement that indicates that the foreign
purchaser understands that the product is not
registered for use in the United States and
cannot be sold in the United States.
(vi) The signature of the foreign purchaser.
(vii) The date of the foreign purchaser's
signature.
(2) Reporting options. At the discretion of the
exporter, the requirements of paragraph (c)(l)
of this section may be met on a per-shipment or
annual basis, as stated in paragraphs (c)(2)(i)
and (c)(2)(ii) of this section. If the procedures
in paragraph (c)(2)(ii) of this section are not
followed, EPA will considerparagraph(c)(2)(i)
of this section, requiring pershipment purchaser
acknowledgment statements, to be applicable in
full. Where paragraph (c)(2)(i) of this sectionis
applicable, each shipment which does not meet
the requirements of that paragraph will be
considered to be a separate violation of FIFRA.
(i) Per-shipment purchaser acknowledgment
statement. Unless the exporter chooses to
follow the procedures described in paragraph
(c)(2)(ii) of this section for the annual reporting
procedures, the exporter must obtain and
submit to EPA, a signed purchaser
acknowledgment statement prior to each
shipment of an unregistered pesticide according
to the following procedures:
(A) Prior to each shipment in a calendar year
of an unregistered pesticide product to a
particular purchaser in a foreign country, the
exporter must provide the foreign purchaser
with instructions about the required information
on a purchaser acknowledgment statement, and
inform the foreign purchaser that the pesticide
product cannot be exported from the United
States until the exporter has received from the
foreign purchaser a properly
Chapter Fourteen • Pesticide Import & Export Program • 14-18
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§168.75
completed, signed, and dated acknowledgment
statement.
(B) The exporter must obtain, prior to each
shipment in a calendar year of an unregistered
pesticide product to a particular purchaser in a
foreign country, a signed purchaser
acknowledgment statement which contains the
information set forth in paragraph (c)( 1) of this
section.
(C) The exporter must sign a statement
certifying that export did not take place until a
signed purchaser acknowledgment statement
was received. The exporter must also specify
the chemical identity of any research product
which is referred to by code in the purchaser
acknowledgment statement. The information
regarding the specific identity of research
products, which may be included in the
statement or consist of an attachment to the
certification, may be claimed as confidential.
(D) The exporter must submit the signed
acknowledgment statement from the foreign
purchaser, and the accompanying certification
by the exporter including attachments, to EPA
within 7 working days of the exporter's receipt
of the purchaser acknowledgment statement, or
by the date of export, whichever occurs first.
This information must be transmitted to the
following address:
U.S. Environmental Protection Agency, Office of
Pesticide Programs, (H-7501C), 401 M Street, SW,
Washington, DC 20460, Attention: Purchaser
Acknowledgment Statement.
(ii) Annual reporting procedures. Unless the
exporter chooses to follow the per-shipment
reporting option described in paragraph
(c)(2)(i) of this section, the exporter must
follow the procedures for annual summary
reporting which include the requirement of a
purchaser acknowledgment statement for the
first shipment each calendar year of an
unregistered pesticide product to a particular
purchaser, and an annual summary of
shipments to that 10:15 Jul 25, purchaser. The
annual summary reporting procedures are as
follows:
(A) Prior to the first shipment each calendar
year of an unregistered pesticide product to a
particular purchaser in a foreign country, the
exporter must provide the foreign purchaser
with instructions about the required information
on a purchaser acknowledgement statement,
and inform the foreign purchaser that the
FIFRA Inspection Manual, February 2002
40 CFR Ch. I (7-1-00 Edition]
pesticide product cannot be exported from the
United States until the exporter has received
from the foreign purchaser a properly
completed, signed, and dated purchaser
acknowledgement statement.
(B) The exporter must obtain, prior to the first
shipment each calendar year of an unregistered
pesticide product to a particular purchaser in a
foreign country, a signed purchaser
acknowledgement statement which contains the
information set forth in paragraph (c)(l) of this
section.
(C) The exporter must sign a statement
certifying that export did not take place until a
signed purchaser acknowledgement statement
was received, indicating that this statement is
for the first shipment to a particular purchaser
in a specific country for that calendar year, and
that the exporter will meet all the purchaser
acknowledgement statement requirements as
described in this paragraph (c)(2)(ii) of this
section. The exporter must also specify the
chemical identity of any research product
which is referred to by code in the purchaser
acknowledgement statement. The information
regarding the specific identity of research
products, which may be included in the
statement or consist of an attachment to the
certification, may be claimed as confidential.
(D) The exporter must submit the signed
acknowledgement statement from the foreign
purchaser, and the accompanying certification
by the exporter including attachments, to EPA
within 7 working days of the exporter's receipt
of the purchaser acknowledgement statement,
or by the date of export, whichever occurs first.
This information must be transmitted to the
following address:
U.S. Environmental Protection Agency, Office of
Pesticide Programs, (H-7501C), 401 M Street, SW,
Washington, DC 20460, Attention: Purchaser
Acknowledgement Statement.
(E) The exporter, who has chosen to comply
with the requirements of this paragraph instead
of providing pershipment purchaser
acknowledgement statements in accordance
with paragraph (c)(2)(i) of this section, must
submit an annual summary report to EPA. An
annual summary report is required for each
unregistered pesticide exported within the
preceding calendar year. The report must be in
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writing, signed by the exporter, and include the
following information:
(1) Name, address, and EPA identification
number if applicable, of the exporter.
(2) Name and address of the foreign
purchaser, and the date the purchaser
acknowledgment statement, submitted to EPA
during the previous calendar year, was signed
by the purchaser.
(3) The identity of the product and the active
ingredients, including: the Chemical Abstract
Services (CAS) registry number for each active
ingredient, the chemical nomenclature for each
active ingredient used by the International
Union of Pure and Applied Chemists (IUPAC),
and other known chemical or common names,
or if the export involves a research product, the
code name or identification number that can be
used by EPA to identify the product from the
exporter's records.
(4) The dates of each shipment of the
pesticide exported to the foreign purchaser
during that calendar year.
(5) If known, or reasonably ascertainable, the
country or countries of final destination of the
export shipments, i.e., where the exported
pesticide was intended to be used, if different
from the foreign purchaser's address.
(F) The exporter shall submit the annual
summary no later than March 1st of the
following calendar year. The annual summary
shall be sent to the following address:
U.S. Environmental Protection Agency, Office of
Pesticide Programs, H-7501C, 401 M Street, SW.,
Washington, DC 20460, Attention: Annual
Summary of Exports.
(iii) Confidentiality claims. Persons
submitting the information specified in 8010
the purchaser acknowledgment statement may
assert a claim of business confidentiality by
marking the information claimed confidential
as "FIFRA Confidential Business
Information.'' Information so claimed will not
be disclosed, with the exception of disclosure
to the foreign governments, except in
accordance with the procedures set forth in 40
CFR part 2, 7 U.S.C. 136(h), and this policy
statement. If such claim is not asserted, EPA
may disclose the information to the public
without providing further notice prior to
disclosure or an opportunity to object.
Notwithstanding any claim of confidentiality,
the purchaser acknowledgment statement will
continue to be
§168.85
forwarded to the appropriate foreign
government officials in its entirety, as required
by section 17(a)(2).
(3) Recordkeeping. Except as specifically
stated, the requirement to retain records under
part 169 of this chapter applies to all pesticide
producers, regardless of whether a particular
product is intended for export. All records shall
be maintained in accordance with the time
period required by § 169.2(h) of this chapter.
Producers must also maintain certain records
pertaining to pesticide products intended for
export. In addition to the requirement that a
copy of the purchaser acknowledgment
statement be kept, as stated at § 169.2(h)(3) of
this chapter, the following records must be
maintained:
(i) Copies of the instructions provided to
foreign purchasers in accordance with
paragraphs (c)(2)(i)(A) and (c)(2)(ii)(A) of this
section.
(ii) Copies of signed purchaser
acknowledgment statements obtained according
to paragraphs (c)(2)(i)(B) and (c)(2)(ii)(B) of
this section.
(iii) Copies of the certification from the
exporter; and copies of any accompanying
information regarding the identity of coded
R&D products.
(d) Agency transmission of purchaser
acknowledgment statements. EPA will transmit
a copy of each purchaser acknowledgment
statement to the appropriate government
official in each of the intended destination
countries. After receipt of the Annual Summary
the following calendar year, EPA will also
transmit a copy of that document
to the appropriate government official in each
of the intended destination countries. In the
case that no Annual Summary has been
received within 30 days of the date at which
such summary is required to be submitted, EPA
will send written notification to the appropriate
government official indicating that no summary
was submitted, and may also take enforcement
action against the exporter.
§ 168.85 Other export requirements.
This section describes other requirements
found in regulations that apply to exporters of
pesticides, devices, and active ingredients
used in producing a pesticide.
(a) Recordkeeping and inspection. Exporters
of pesticides, devices and active ingredients
Chapter Fourteen • Pesticide Import & Export Program • 14-20
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§168.85
must keep records and permit inspections of
those records in accordance with part 169 of
this chapter. Exporters must keep records of the
product labeling used, including the EPA
registered labeling, any foreign labeling on or
attached to the product when shipped, and, as
applicable, any supplemental labeling used.
Producers of pesticides for export shall
maintain these records in a manner that shows
exactly which labels and labeling accompanied
each shipment of a pesticide product to a
foreign country. As stated at § 168.75(c), when
research product identity information appears
on the labeling in an encoded manner,
information translating the code shall be
maintained in records. These records shall be
maintained for the time period required by §
169.2(h) of this chapter following the last
export of such pesticides. All records required
by part 169 of this chapter shall be made
available for inspection and copying by EPA or
its duly authorized representatives.
(b) Pesticide production establishment
requirements. Exporters of pesticides, devices,
and active ingredients must submit annual
reports to EPA in accordance with part 167 of
this chapter, concerning those products that are
exported. All products required to be labeled
' 'Not Registered for Use in the United States of
America" must be reported as unregistered
production regardless of whether a purchaser
acknowledgment statement is required.
FIFRA Inspection Manual, February 2002
40 CFR Ch. I (7-1-00 Edition]
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FIFRA Inspection Manual, February 2002
Exhibit 14-2: FIFRA Export Inspection Checklist
FIFRA EXPORT INSPECTION CHECKLIST
Company Est. No.
Address Inspection Date .
Inspector's Name and Phone Number _
Product Name and (EPA Reg #)
Part I - Documentation Obtained YES/NO/Exhibit #
1) Are Section 7 Production Reports (#3540-16) included for this product
for each targeted calendar year? [If reporting discrepancies were found,
not in "Comments" section on page 2 of this form.]
2) Is the Confidential Statement of Formula or chemical formula included for
this product?
3) Are production specifications/directions of the foreign purchaser included for
this product?
If not, is statement form the appropriate company official as to why these
records are not maintained by the facility?
Is the actual location of the records known and included?
4) Are label(s)/supplemental labeling included for this product for each country
to which it was exported?
No. of Countries No. of labels
5) If product labels/labeling were not available, are bin labels included for this
product?
Is an affidavit statement from the responsible company official included
certifying that the labels/labeling or bin labels/labeling collected are identical
to those used on exported product(s)?
Is photographic evidence of the product that was packaged, labeled and
released for shipment at the time of the inspection included?
6) If labels were not available for inspection, is affidavit statement from the
appropriate company official included as to why labels were not maintained
by the facility? Is the actual location of the labels known and included?
7) Are foreign purchaser acknowledgment statements, as required by
section 17(a)(2), included for the first shipment each year of a particular
product to a particular purchaser for each importing country?
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FIFRA Inspection Manual, February 2002
If not, is an affidavit statement included?
8) If the unregistered product was claimed to be "substantially similar" to an
EPA registered product, is an affidavit statement included from a responsible
company official specifically documenting such claims including the registered
product name, EPA registration number, and rationale for such claims?
9) If the unregistered product was claimed to be a "research & development" or
"experimental" pesticide, is an affidavit included from the responsible
company official specifically describing the basis for such claims?
10) OPTIONAL If the unregistered product is claimed "substantially similar" to an
EPA registered product, is a copy of the label for the registered product and
Confidential Statement of Formula for the registered product included?
11) Is evidence of exported shipments included that clearly shows the product name,
date(s) of each shipment, amounts of each shipment, and country of destination
for each shipment? (This can include Bills of Lading, Invoices, and List of
Consignees.)
12) Is evidence included that clearly shows the company responsible fore the
product and its export? Is evidence included that clearly describes past and
present corporate relationships, such as, mergers, takeovers and/or other
corporate transactions/agreements?
13) Was information included for this product for all time periods requested?
2000 _ 2001_ 2002 _ 2003 _
COMMENTS:
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FIFRA Inspection Manual, February 2002
Part II - Labeling Requirements and Review
Does the label/Labeling for this exported product bear the following information? Attach a separate Part
II sheet for each product label and foreign destination.
Product Name: Foreign Destination:
Yes No
1. EPA Establishment Number?
2. Ingredient Statement?
3. Name/address of producer/registrant?
4. Statement of net weight or measure?
5. Use Classification statement?
(Restricted Use or General Use Pesticide)
6. Precautionary statements?
(Warning and caution statements)
7. If highly toxic, are "skull & crossbones", the word Poison
and statement of practical treatment shown?
8. For unregistered products, does label bear the statement "Not
Registered for Use in the United States of America"?
9. If the predominant language of the importing country is not
English, are #'s 2, 6, 7, and 8 above also expressed in the
language of the importing country? (Note that this
information is required on both registered and unregistered
products.)
Label Comments
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FIFRA Inspection Manual, February 2002
Exhibit 14-3: Pesticide Registration (PR) Notice 99-1
March 1,1999
Notice to Manufacturers, Producers, Formulators, Registrants and Importers of Pesticide
Products
ATTENTION: Persons Responsible for the Importation of Pesticide Products
SUBJECT: Import of Unregistered Pesticides Intended for Export
I. SUMMARY
This Pesticide Registration (PR) notice clarifies EPA's interpretation of the scope of the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 17 (a)(l), as it relates to the
import of unregistered pesticides, devices or active ingredients used in producing a pesticide
when the importation is solely for the purpose of formulation or packaging for subsequent
export. Under the interpretation provided in this PR notice, such pesticides do not require
registration under FIFRA, as long as they comply with the provisions outlined below. This
interpretation is effective immediately.
In general, unregistered pesticides and unregistered active ingredients are not permitted to
be imported. However, if a pesticide or unregistered active ingredient is being imported for the
sole purpose of meeting the specifications of a foreign purchaser, such an import is permitted.
The Agency interprets Section 17(a)(l) to allow the importation of unregistered pesticides or
unregistered active ingredients used in producing a pesticide, provided the ultimate pesticide is
produced for export only according to the specifications of the foreign purchaser. This policy
does not authorize the importation of unregistered pesticide for the purpose of producing a U.S.
registered product, even if part or all of that production is intended for export.
II. BACKGROUND
The Agency has received requests from a number of companies to allow importation of
unregistered pesticidal active ingredients for the purpose of allowing reformulation into a
pesticide intended to be exported. The requesters have essentially asked the Agency to
interpret section 17(a) of FIFRA in a way that would exempt such importation from the
requirements of FIFRA. That section provides in part that "no pesticide or device or active
ingredient used in producing a pesticide intended solely for export to any foreign country shall
be deemed in violation of [FIFRA] when prepared or packed according to the specifications or
directions of the foreign purchaser," provided the producers of such pesticides, devices, or
active ingredients used in producing pesticides comply with various specified provisions of
FIFRA sections 2, 7 and 8.
III. CLARIFICATION OF SCOPE OF SECTION 17
A. Conditions Permitting Import
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FIFRA Inspection Manual, February 2002
Having considered this issue, EPA believes there are certain circumstances under which
unregistered pesticides and/or active ingredients may be imported into this country consistent
with section 17. Specifically, EPA will consider importation of an unregistered pesticide or
active ingredient into this country to be a lawful act under FIFRA if all of the following
conditions apply:
1. The foreign producing establishment is registered under FIFRA Section 7 and is
compliant with Section 7 reporting requirements.
2. Importation of the unregistered pesticide or active ingredient complies with all
applicable regulations and section 17 of FIFRA (including presentation of an EPA
authorized Notice of Arrival which specifies the quantities to be exported to Customs
upon entry into the U.S.).
3. The shipment otherwise complies with all applicable Customs laws and
regulations.
4. Upon lawful release by Customs, the imported unregistered pesticide or active
ingredient is transported directly to a registered pesticide establishment. The owner of
such establishment shall be responsible for filing an appropriate report under FIFRA
section 7 concerning such imported pesticide or active ingredient which indicates the
relevant activity, such as reformulation, relabeling or distribution.
5. Section 17(a) allows distribution (and importation) of an unregistered pesticide
or active ingredient only if the pesticide or active ingredient are intended solely for
export and have been prepared or packaged according to the specifications of the
foreign purchaser. EPA interprets this to mean that the importation (and any
subsequent movement) may occur only after a foreign purchaser has been identified and
has provided the specifications for the exported product.
6. After the final product for export is formulated and packaged, any distribution
or shipment of the product must be solely for the purpose of facilitating export of the
product (i.e., all movement of the product must be directly related to exporting the
product, such as shipment to a warehouse awaiting export, dock or broker).
7. The unregistered pesticide or active ingredient, and each person with any
obligation under FIFRA section 2, 7, or 8 with respect to the unregistered pesticide or
active ingredient, are at all times in compliance with all the applicable provisions of
FIFRA identified in 17(a)(l).
8. The export of any unregistered pesticide or active ingredient complies with the
purchaser acknowledgment requirements of 17(a)(2) of FIFRA.
9. The importer can demonstrate that, ultimately, all of the product has been
exported, or is being held pending export.
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FIFRA Inspection Manual, February 2002
B. Conditions after importation
EPA will consider any shipment or distribution after the original importation to a registered
facility in the United States to be permissible under FIFRA (including section 17(a)) under the
following conditions:
1. The shipment is either in compliance with 40 CFR 152.30 (a) (the shipment is
between registered establishments owned or operated by the same producer) or,
2. The shipment is distributed only to facilitate export (the pesticide or active
ingredient has been prepared or packaged according to the specifications of an
identified foreign purchaser).
If any other shipments or distributions of an unregistered pesticide or active ingredient are
made in the United States after the initial importation, the shipper is advised to have evidence
indicating that the shipment conforms to the conditions outlined above. By way of example,
such evidence could include an identification of the foreign purchaser, an explanation of why
the shipment or distribution is necessary to facilitate legal export of a product under section
17(a) of FIFRA. Failure to produce such evidence could result in otherwise unnecessary
stopping of the shipment, and/or a violation of FIFRA for selling or distributing an unregistered
pesticide outside this limited exemption.
IV. FOR FURTHER INFORMATION
Any questions should be directed to: Cathleen M. Barnes, Government and International
Services Branch, Field and External Affairs Division (7501C), Office of Pesticide Programs,
USEPA, 401 M Street, S.W., Washington D.C., 20460, phone:703-305-7101, fax:703-308-1850, e-
mail: barnes.cathleen@epa.gov.
Marcia E. Mulkey
Director, Office of Pesticide Programs
Chapter Fourteen • Pesticide Import & Export Program • 14-27
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FIFRA Inspection Manual, February 2002
Exhibit 14-4: Notice of Arrival of Pesticides and Devices (EPA Form 3540-1)
United States Environmental Protection Agency
Washington, DC 20460
Notice of Arrival of
Pesticides and Devices
Note: Read Instructions on reverse before completing form.
Send Completed Form to
Appropriate Regional Office
Listed on the Reverse of this
Form.
Form Approved
OMB No. 2070-0020
Part I: To Be Completed by Importer or Agent
1. Name and Complete Address of Broker or Agent
2. Name and Complete Address of Importer or Consignee
D
Return Form to this Address
Return Form to this Address
3. Name and Address of Shipper
4. EPA Registration Number
5. EPA Producer Establishment No.
6. Brand name of Product
7. Major Active Ingredients and Percentage of Each
8. Unit Size
9. Quantity
10. Total Net Weight
11. Country of Origin
12. Port of Entry
13. Carrier
14. Entry Number
15. Entry Date
17. Location of Goods for Examination after Importation
16. I assert that information constituting Confidential Business
Information is shown in the above blocks numbered: (Note:
Blocks 4, 5,6, 7 are not entitled to CBI treatment-see Instructions)
18. Remarks
Certification
I certify that the statements I have made on this form and all attachments thereto are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable law.
19. Printed Name of Importer or Agent
Telephone Number
20. Signature of Importer or Agent
Date Signed
Part II: To Be Completed by U.S. Environmental Protection Agency
Action to be taken by U.S. Customs Service
| | Release Shipment Detain for Inspection
Other (Specify)
Release shipment to consignee under bond. Shipment must
be held intact pending inspection.
Remarks
Signature and Title of EPA Official
Date
Part III: To Be Completed by U.S. Customs Service
The information shown in Part I was compared with the entry papers for this shipment and no discrepancies were noted. The shipment
was handled as instructed by EPA in Part II. Any deviations should be brought to the attention of EPA before releasing shipment and
should also be noted in "Remarks."
Remarks
Signature of District Director of Customs
Date
EPA Form 3540-1 (Rev. 2-00)
Official File Copy
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FIFRA Inspection Manual, February 2002
Exhibit 14-5
§12.110
19 CFRCh. 1(4-1-01 Edition)
PESTICIDES AND DEVICES
§12.110 Definitions.
Except as otherwise provided below, the
terms used in §§ 12.111 through 12.117 shall
have the meanings set forth for those terms in
the Federal Insecticide, Fungicide, and
Rodenticide Act, as amended (7 U.S.C. 136 et
seq.), hereinafter referred to as ' 'the Act.'' The
term Administrator shall mean the
Administrator of the Environmental Protection
Agency.
[T.D. 75-194, 40 FR 32321, Aug. 1, 1975]
§12.111 Registration.
All imported pesticides are required to be
registered under the provisions of section 3 of
the Act, and under the regulations (40 CFR
162.10) promulgated thereunder by the
Administratorbefore being permitted entry into
the United States. Devices, although not
required to be registered, must not bear any
statement, design, or graphic representationthat
is false or misleading in any particular.
[T.D. 75-194, 40 FR 32321, Aug. 1, 1975]
§12.112 Notice of arrival of pesticides
and devices.
(a) General. An importer desiring to import
pesticides or devices into the United States
shall submit to the Administrator a Notice of
Arrival of Pesticides and Devices
(Environmental Protection Agency Form
3540-1), hereinafter referred to as a Notice of
Arrival, prior to the arrival of the shipment in
the United States. The Administrator shall
complete the Notice of Arrival, indicating the
disposition to be made of the shipment of
pesticides or devices upon its arrival in the
United States, and shall return the completed
Notice of Arrival to the importer or his agent.
(b) Chemicals imported for use other than as
pesticides. Chemicals which can be used as
pesticides but which are not imported for such
use and are not shown on the Abbreviated List
of Pesticides compiled by the Environmental
Protection Agency, may be entered without the
submission of the Notice of Arrival.
[T.D. 75-194, 40 FR 32321, Aug. 1, 1975]
§12.113 Arrival of shipment.
(a) Notice of arrival presented. Upon the
arrival of a shipment of pesticides or devices, the
importer or his agent shall present to the director
of the port of entry the Notice of Arrival
completed by the Administrator and indicating
the Customs action to be taken with respect to
the shipment. The port director shall compare
entry documents for the shipment of pesticides
or devices with the Notice of Arrival and notify
the Administrator of any discrepancies, (b)
Notice of arrival not presented. When a
shipment of pesticides or devices arrives in the
United States without the presentation by the
importer or his agent of the Notice of Arrival
completed by the Administrator, the shipment
shall be detained by the director of the
importer's risk and expense until the completed
Notice of Arrival is presented or until other
disposition is ordered by the Administrator, but
not to exceed a period of 30 days, or such
extended period, not in excess of 30 additional
days, as the port director for good cause may
specially authorize. An application of the
importer or his agent requesting an extension of
the initial 30-day period shall be filed with the
director of the port of entry, (c) Disposition of
pesticides or devices remaining under detention.
A shipment that remains detained or undisposed
of due to failure of presentment of a completed
Notice of Arrival or nonreceipt of an order of the
Administrator as to its disposition shall be
treated as a prohibited importation. The port
director shall cause the destruction of any such
shipment not exported by the consignee within
90 days after the expiration of the detention
period specified or authorized pursuant to §
[T.D. 75-194, 40 FR 32322, Aug. 1,1975]
§ 12. 1 14 Release or refusal of delivery.
If the completed Notice of Arrival directs the
port director to release the shipment of pesticides
or devices, the shipment shall be released to the
consignee. If the completed Notice of Arrival
directs the port director to refuse delivery of the
shipment, the shipment shall be refused delivery
and treated as a prohibited importation. The port
director shall cause the destruction of any
shipment refused delivery and not exported by
the consignee within 90 days after notice of such
refusal of delivery. [T.D. 75-194, 40 FR 32322, Aug.
1, 1975]
Chapter Fourteen • Pesticide Import & Export Program • 14-29
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FIFRA Inspection Manual, February 2002
United States Customs Service, Treasury
§12.116
§12.115 Release under bond.
If the completed Notice of Arrival so directs,
a shipment of pesticides or devices shall be
detained at the importer's expense by the port
director pending an examination by the
Administrator to determine whether the
shipment complies with the requirements of the
Act. However, a shipment detained for
examination may be released to the consignee
prior to a determination] by the Administrator
provided a bond is furnished on Customs Form
301, containing the bond conditions set forth in
§ 113.62 of this chapter, for the return of the
merchandise to Customs custody. The bond
shall be in an amount deemed appropriate by
the port director. When a shipment of pesticides
or devices is released to the consignee under
bond, the shipment shall not be used or
otherwise disposed of until the determination is
made by the Administrator.
[T.D. 75-194, 40 FR 32322, Aug. 1, 1975, as amended by
T.D. 84-213, 49 FR41168, Oct. 19, 1984]
§ 12.116 Samples.
Upon the request of the Administrator, either
on the completed Notice of Arrival or
otherwise, the port director shall deliver to the
Administrator samples of the imported
pesticides or devices, together with all
accompanying labels, circulars, and advertising
matter pertaining to such merchandise. The port
director shall notify the consignee, in writing,
that the samples of imported pesticides or
devices, together with all accompanying labels,
circulars, and advertising matter pertaining to
such merchandise have been delivered to the
Administrator.
[T.D. 75-194, 40 FR 32322, Aug. 1, 1975]
§ 12.117 Procedure after examination.
(a) Merchandise complying with the Act. If,
upon examination or analysis of a sample from
a shipment of pesticides or devices, the sample
is found to be in compliance with the Act, the
Administrator shall notify the port director that
the shipment may be released to the consignee.
(b) Merchandise not complying with the Act. If,
upon examination or analysis of a sample from
a shipment of pesticides or devices, the sample is
found to be in violation of the Act, the consignee
shall be notified promptly by the Administrator
of the nature of the violation and be given a
reasonable time, not to
exceed 20 days, to submit written material of, at
his option, to appear before the Administrator an
introduce testimony to show cause why the
shipment should not be destroyed or refused
entry. If after consideration of all the evidence
presented, it is still the opinion of the
Administrator that the merchandise is in
violation of the Act, the Administrator shall
notify the port director of this opinion and the
port director shall either (1) refuse delivery to
the consignee, or (2) if the shipment has been
released to the consignee under bond, demand
redeliver of the shipment under the terms of the
bond. If the merchandise is not redelivered
within 30 days after the date of demand by the
prot director, the port director shall issue a
demand for liquidated damages in the full
amount of the bond, or if a continuous bond is
used, the amount that would have been taken
under a single entry bond. The port director shall
cause the destructionof any merchandise refused
delivery to the consignee or redelivered by the
consignee pursuant to a demand therefore, and
not exported by the consignee within 90 days
after notice of such refusal of delivery or within
90 days after such redeliver, as applicable.
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FIFRA Inspection Manual, February 2002
Exhibit 14-6: FIFRA Import Inspection Checklist
* For use after the Regional Office import coordinator has determined to inspect a shipment and
has setup a location for the shipment to be inspected.
Inspector's Name/Number _ i _
1) Location of shipment to be inspected
The following information can be obtained from the Notice of Arrival (NOA) Form 3540-1 or
the papers accompanying the shipment. If a NOA has been completed it can be obtained from
the Regional Office import coordinator.
2) Importer/Consignee 3) Shipper
Address Address
4) Broker/Agent 5) Carrier
Address
6) EPA Registration Number 7) EPA Establishment Number
8) Brand Name of Product
9) Major Active Ingredients and Percentage of Each
10) Unit size 11) Quantity . 12) Total Net Weight
Inspection Procedures:
Check if Applicable
13) Obtain a copy of the EPA approved label from the EPA Regional Office
14) Prior to inspecting a shipment of pesticides and/or devices, request from the
importer/consignee or customs broker copies of the product label and, if
Chapter Fourteen • Pesticide Import & Export Program • 14-31
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FIFRA Inspection Manual, February 2002
available other advertisements accompanying the sale of the product.
15) Issue NOI and show federal credentials to appropriate person.
16) Collect photographs of the label(s) and labeling on the container(s) of the import shipment.
Review for conformity with label requirements (Procedures for conducting label
reviews can be found in Chapter 7 of the Pesticide Inspection Manual).
17) Collect all records regarding import of shipment, such as:
Copies of NOA
Foreign invoices
Shipping records (i.e.,
manifests or waybills)
18) Review other label information in books, pamphlets, circulars, and
displays - if applicable.
19) Document the physical condition of the lot.
20) Photograph containers and the labels thereon.
If physical samples are taken, follow these additional steps:
21) Note on Receipt for Samples that it is an import sample, and identify
the sample with "IMP" preceding the sample number.
22) Request that the laboratory expedite the analysis
23) Ensure that the product container is properly resealed.
24) Notify the Regional Office that samples have been collected.
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Exhibit 14-7: Model Release Notice
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Name, President
Company Name
Company Address
Re: RELEASE NOTICE
Entry Number (Assigned by Customs) (Product Name)
Dear (President's Name):
In connection with the enforcement of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA, or the Act), as amended, 7 U.S.C. 136 et al., the United States
Environmental Protection Agency has completed its consideration of the following
shipment. Base on examination of samples or other evidence, the Agency concludes that,
pursuant to Section 17(c) of the Act, you need not further detain the merchandise.
Sample Number (if an inspection has been conducted):
Product Name:
Shipper/Manufacturer: Consignee:
Entry Number: Date of Importation: Port of Entry:
This Notice does not constitute assurance that the merchandise involved complies with
all provisions of the act and in no way precludes further action should the Agency determine
that the merchandise is in violation of any federal environmental requirement.
Sincerely,
/s/
(Name and Title)
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Exhibit 14-8: Model Notice of Refusal of Admission
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Name, President
Company Name
Company Address
Re: NOTICE OF REFUSAL OF ADMISSION
Entry Number (Assigned by Customs) (Product Name)
Dear (President's Name):
In connection with the enforcement of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA, or the Act), as amended, 7 U.S.C. 136 et al., the United States
Environmental Protection Agency has examined samples or other evidence with respect to
the following shipment and has granted to you an opportunity for a hearing.
Sample Number (if an inspection has been conducted):
Product Name:
Shipper/Manufacturer: Consignee:
Entry Number: Date of Importation: Port of Entry:
It appears that the product is not in compliance with the Act and is subject to refusal of
admission due to the following violations (Describe violations).
The Agency hereby notifies you that your merchandise has been refused admission.
You must export this merchandise, under supervision of the U.S. Customs Service, within
ninety (90) calendar days from the date of this Notice (or within such time as otherwise
specified by EPA) or within such additional time as the District Director of Customs
specifies. Failure to do so may result in either the destruction of the merchandise as
authorized by the Act, or, if the shipment has been released to you under bond, in any action
necessary to enforce the terms of said bond.
Sincerely,
/s/
(Name and Title)
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Exhibit 14-9: Model Notice of Detention and Hearing
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Name, President
Company Name
Company Address
Re: NOTICE OF DETENTION AND HEARING
Entry Number (Assigned by Customs) (Product Name)
Dear (President's Name):
In connection with the enforcement of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA, or the Act), as amended, 7 U.S.C. 136 et al., the United States
Environmental Protection Agency has examined samples or other evidence concerning the
shipment described below, and has determined that said shipment is in violation of the Act.
You should continue to hold the merchandise pending a final decision as to whether it shall
be admitted or refused admission.
Pursuant to Section 17(c) of the Act, the Agency hereby affords you an opportunity to
offer such explanation as you wish for the Agency's consideration. You should file your
answer, signed by you or your attorney, with this office within twenty (20) calendar days
after your receipt of this Notice. Should you desire to present your views verbally, in
addition to filing a written reply, you should advise us in your answer in order that we may
set a date for such presentation, which should be held in this office or via teleconference.
Sample Number (if an inspection has been conducted):
Product Name:
Shipper/Manufacturer: Consignee:
Entry Number: Date of Importation: Port of Entry:
Upon examination, it appears the product(s) failed to comply with the provisions of the
Act in that (describe violation). I am enclosing a copy of EPA's FIFRA Enforcement
Response Policy, dated July 2,1990.
Sincerely,
/s/
(Name and Title)
Enclosure
Chapter Fourteen • Pesticide Import & Export Program • 14-35
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FIFRA Inspection Manual, February 2002
Exhibit 14-10
United States Customs Service, Treasury
§12.1
MERCHANDISE SUBJECT TO ECONOMIC
SANCTIONS
12.150 Merchandise prohibited by economic sanctions;
detention; seizure or other disposition; blocked property.
AUTHORITY: 5 U.S.C. 301; 19 U.S.C. 66, 1202
(General Note 22, Harmonized Tariff Schedule of the
United States (HTSUS)), 1624; Section 12.1 also issued
under 21 U.S.C.371(b);
Section 12.3 also issued under 7 U.S.C. 135h, 21 U.S.C.
381(b);
Section 12.4 also issued under 21 U.S.C. 381(b);
Section 12.6 also issued under 7 U.S.C. 1854, 19 U.S.C.
1303;
Section 12.10 also issued under 7 U.S.C. 151- 162;
Section 12.15 also issued under 19 U.S.C. 1558;
Section 12.16 also issued under 7 U.S.C. 1592(b);
Sections 12.21 through 12.23 also issued under 42 U.S.C.
262;
Section 12.26 also issued under 18 U.S.C. 42; Section
12.28 also issued under 18 U.S.C. 42, 19 U.S.C. 1527;
Section 12.34 also issued under 19 U.S.C. 1202
(additional U.S. Note to Chapter 36, HTSUS);
Section 12.37 also issued under 27 U.S.C. 203;
Section 12.39 also issued under 19 U.S.C. 1337, 1623;
Sections 12.40 and 12.41 also issued under 19 U.S.C.
1305;
Sections 12.42through 12.44 also issued under 19U.S.C.
1307 and Pub. L. 105-61 (111 Stat. 1272);
Sections 12.73 and 12.74 also issued under 19 U.S.C.
1484, 42 U.S.C. 7522, 7601;
Section 12.85 also issued under 19 U.S.C. 1623,46 U.S.C.
4302,4306,4310;
Sections 12.95 through 12.103 also issuedunder 15 U.S.C.
1241-1245;
Sections 12.104 through 12.104i also issued under 19
U.S.C. 2612.
Sections 12.105 through 12.109 also issued under 19
U.S.C. 2094;
Sections 12.110 through 12.117 also issuedunder 7U.S.C.
136 et seq.;
Sections 12.118 through 12.127 also issued under 15
U.S.C. 2601 etseq.;
Sections 12.130 and 12.131 also issued under 7 U.S.C.
1854;
Section 12.140 also issued under 19U.S.C. 1484,2416(a),
2171;
Section 12.150 also issued under 19 U.S.C. 1595a and
1618; 22 U.S.C. 401.
EFFECTIVE DATE NOTE: By T.D. 01-26, 66
FR 16853, Mar. 28, 2001, in part 12, the
specific authority citation for § 12.3
was revised, effective Apr. 27, 2001.
For the convenience of the user, the
revised text is set forth as follows:
Section 12.3 also issued under 7 U.S.C.
135h, 21 U.S.C. 381;
SOURCE: 28 FR 14710, Dec. 31, 1963, unless otherwise noted.
FOOD, DRUGS, AND COSMETICS, ECONOMIC
POISONS, HAZARDOUS SUBSTANCES, AND
DANGEROUS CAUSTIC OR CORROSIVE
SUBSTANCES
§12.1 Cooperation with certain agencies; joint
regulations.
(a) Federal Food, Drug, and Cosmetic Act. The
importation into the United States of food, drags,
devices, and cosmetics as defined in section 201
(f), (g), (h), and (i) of the Federal Food, Drag, and
Cosmetic Act (21 U.S.C. 321 (f), (g), (h), (i)) is
governed by section 801 of the Act, as amended
(21 U.S.C. 381) and regulations issued under
authority of section 701(b) of the Act (21 U.S.C.
371(b)) by the Secretary of Health and Human
Services and the Secretary of the Treasury (21
CFR 1.83 through 1.99).
(b) Federal Insecticide, Fungicide, and
Rodenticide Act. The importation of pesticides
and devices is governed by section 17(c) of the
Federal Insecticide, Fungicide, and Rodenticide
Act, as amended (7 U.S.C. 136o(c)), and
regulations issued under the authority of section
17(e) of that Act (7 U.S.C. 1360(e)) by the
Secretary of the Treasury, in consultation with the
Administrator of the Environmental Protection
Agency, as set forth below (§ 12.110 et seq.).
(c) Federal Hazardous Substances Act. The
importation of hazardous substances, misbranded
hazardous substances, or banned hazardous
substances as defined in section 2 of the Federal
Hazardous Substances Act, as amended (15
U.S.C. 1261), is governed by regulations issued
underthe authority of sections 10(b) and 14 of the
Act, as amended (15 U.S.C. 1269, 1273), by the
Consumer Product Safety Commission (16 CFR
1500.265 through 1500.272).
[T.D. 68-191, 33 FR 11019, Aug. 2, 1968, as amended by
T.D. 75-194,40 FR32321, Aug. 1,1975; T.D. 82-145,47FR
35475, Aug. 16, 1982]
Chapter Fourteen • Pesticide Import & Export Program • 14-36
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Exhibit 14-11
United States Customs Service, Treasury
FIFRA Inspection Manual, February 2002
§113.62
Subpart G—Customs Bond
Conditions
§ 113.61 General.
Each section in this subpart identifies specific
coverage for a particular Customs activity. When
an individual or organization files a bond with
Customs the activity in which they plan on
engaging will be identified on the bond. The bond
conditions listed in this subpart which correspond
to that activity will be incorporated by reference
into the bond.
§ 113.62 Basic importation and entry bond conditions.
A bond for basic importation and entry shall
contain the conditions listed in this section and
may be either a single entry or a continuous bond.
BASIC IMPORTATION AND ENTRY BOND
CONDITIONS
(a) Agreement to Pay Duties, Taxes, and
Charges. (1) If merchandise is imported and
released from Customs custody or withdrawn
from a Customs bonded warehouse into the
commerce of, or for consumption in, the United
States, or under § 181.53 of this chapter is
withdrawn from a duty-deferral program for
exportation to Canada or Mexico or for entry into
a duty-deferral program in Canada or Mexico, the
obligors (principal and surety, jointly and
severally) agree to:
(i) Deposit, within the time prescribed by law or
regulation, any duties, taxes, and charges
imposed, or estimated to be due, at the time of
release or withdrawal; and
(ii) Pay, as demanded by Customs, all additional
duties, taxes, and charges subsequently found
due, legally fixed, and imposed on any entry
secured by this bond.
(2) If the principal enters any merchandise into
a Customs bonded warehouse, the obligors agree;
(i) To pay any duties, taxes, and charges found
to be due on any of that merchandise which
remains in the warehouse at the expiration of the
warehousing time limit set by law; and
(ii) That the obligation to pay duties, taxes, and
charges on the merchandise applies whether it is
properly withdrawn by the principal, or by the
principal's transferee, or is unlawfully removed
by the principal or any other person, without
regard to whether the merchandise is
manipulated,
unless payment was made or secured to be made
by some other person
regard to whether the merchandise is
manipulated, unless payment was made or
secured to be made by some other person.
(3) Under this agreement, the obligation to pay
any and all duties, taxes, and charges due on any
entry ceases on the date the principal timely files
with the port director a bond of the owner in
which the owner agrees to pay all duties, taxes,
and charges found due on that entry; provided a
declaration of the owner has also been properly
filed.
(b) Agreement to Make or Complete Entry. If
all or part of imported merchandise is released
before entry under the provisions of the special
delivery permit procedures under 19 U.S.C.
1448(b), released before completion of the entry
under 19 U.S.C. 1484(a), or withdrawn from
warehouse under 19 U.S.C. 1557(a) (see §
10.62b of this chapter), the principal agrees to
file within the time and in the manner prescribed
by law and regulation, documentation to enable
Customs to:
(1) Determine whether the merchandise may
be released from Customs custody;
(2) Properly assess duties on the merchandise;
(3) Collect accurate statistics with respect to
the merchandise; and
(4) Determine whether applicable requirements
of law and regulation are met.
(c) Agreement to Produce Documents and
Evidence. If merchandise is released
conditionally to the principal before all required
documents or other evidence is produced, the
principal agrees to furnish Customs with any
document or evidence as required by law or
regulation, and within the time specified by law
or regulations.
(d) Agreement to Redeliver Merchandise. If
merchandise is released conditionally from
Customs custody to the principal before all
required evidence is produced, before its
quantity and value are determined, or before its
right of admission into the United States is
determined, the principal agrees to redeliver
timely, on demand by Customs, the merchandise
released if it:
(1) Fails to comply with the laws or
regulations governing admission into the United
States;
(2) Must be examined, inspected, or appraised
as required by 19 U.S.C. 1499; or
(3) Must be marked with the country of origin
Chapter Fourteen • Pesticide Import & Export Program • 14-37
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FIFRA Inspection Manual, February 2002
§113.62
as required by law or regulation. It is understood
that any demand for redeliver will be made no
later than 30 days after the date that the
merchandise was released or 30 days after the end
of the conditional release period (whichever is
later).
(e) Agreement to Rectify Any Non-Compliance
with Provisions of Admission. If merchandise is
released conditionally to the principal before its
right of admission into the United States is
determined, the principal, after notification,
agrees to mark, clean, fumigate, destroy, export or
do any other thing to the merchandise in order to
comply with the law and regulations governing its
admission into the United States within the time
period set in the notification.
(f) Agreement for Examination of Merchandise.
If the principal obtains permission to have any
merchandise examined elsewhere than at a wharf
or other place in charge of a Customs officer, the
principal agrees to:
(1) Hold the merchandise at the place of
examination until the merchandise is properly
released;
(2) Transfer the merchandise to another place
on receipt of instructions from Customs made
before release; and
(3) Keep any Customs seal or cording on the
merchandise intact until the merchandise is
examined by Customs.
(g) Reimbursement and Exoneration of the
United States. The obligors agree to:
(1) Pay the compensation and expenses of any
Customs officer, as required by law or regulation;
and
(2) Exonerate the United States and its officers
from any risk, loss, or expense arising out of
principal's importation, entry, or withdrawal of
merchandise.
(h) Agreement on Duty-Free Entries or
Withdrawals. If the principal enters or withdraws
any merchandise, without payment of duty and
tax, or at a reduced rate of duty and tax, as
permitted under the law, the principal agrees:
(1) To use and handle the merchandise in the
manner and for the purpose entitling it to duty-
free treatment;
(2) If a fishing vessel, to present the original
approved application to Customs within 24 hours
on each arrival of the vessel in the Customs
territory of the United States from a fishing
voyage;
(3) To furnish timely proof to Customs that any
merchandise entered or withdrawn under any law
19 CFRCh. 1(4-1-01 Edition)
permitting duty-free treatment was used in
accordance with that law; and (4) To keep safely
all withdrawn beverages remaining on board
while the vessel is in port, as may be required by
Customs.
(i) Agreement to comply with Customs
Regulations applicable to Customs security
areas at airports. If access to the Customs
security areas at airports is desired, the principal
(including its employees, agents, and
contractors) agrees to comply with the Customs
Regulations in this chapter applicable to
Customs security areas at airports. If the
principal defaults, the obligors (principal and
surety, joint and severally) agree to pay
liquidated damages of $ 1000 for each default or
such other amount as may be authorized by law
or regulation.
(j) Agreement to comply with electronic entry
filing requirements. If the principal is qualified
to utilize electronic entry filing as provided for
in part 143, subpart D, of this chapter, the
principal agrees to comply with all conditions set
forth in that subpart and to send and accept
electronic transmissions without the necessity of
paper copies.
(k) Agreement to ensure and establish issuance
of softwood lumber export permit and collection
of export fees. In the case of a softwood lumber
product imported from Canada that is subject to
the requirement that the Government of Canada
issue an export permit pursuant to the Softwood
Lumber Agreement, the principal agrees, as set
forth in § 12.140(a) of this chapter, to assume
the obligation to ensure within 20 working days
of release of the merchandise, and establish to
the satisfaction of Customs, that the applicable
export permit has been issued by the
Government of Canada.
(1) Consequence of default. (1) If the principal
defaults on agreements in this condition other
than conditions (a), (g), or (i) the obligors agree
to pay liquidated damages equal to the value of
the merchandise involved in the default, or three
times the value of the merchandise involved in
the default if the merchandise is restricted
merchandise or alcoholic beverages, or such
other amount as may be authorized by law or
regulation.
(2) It is understood and agreed that whether the
default involves merchandise is determined by
Customs and that the amount to be collected
under these conditions shall be based upon the
quantity and value of the merchandise as
determined by Customs. Value as used in these
Chapter Fourteen • Pesticide Import & Export Program • 14-38
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FIFRA Inspection Manual, February 2002
United States Customs Service, Treasury § 113.62
provisions means value as determined under 19 , Restricted'' effective Apr
U.S.C. 1401a.
(3) If the principal defaults on agreements in
this condition other than conditions (a) or (g) and
the default does not involve merchandise, the
obligors agree to pay liquidated damages of
$1,000 for each default or such other amount as
may be authorized by law or regulation.
(4) If the principal defaults on agreements in the
condition set forth in paragraph (a)(l)(i) of this
section only, the obligors (principal and surety,
jointly and severally) agree to pay liquidated
damages equal to two times the unpaid duties,
taxes and charges estimated to be due or $1,000,
whichever is greater. A default on the condition
setforth in paragraph (a)(l)(i) of this sectionshall
be presumed if any monetary instrument
authorized for the payment of estimated duties,
taxes and charges by § 24.1(a) of this chapter is
returned unpaid by a financial institution, or if a
payment authorized under Automated
Clearinghouse (see § 24.25 of this chapter) is not
transmitted electronically to Customs in a timely
manner. If the principal defaults on agreements in
both of the conditions as set forth in paragraphs
(a)(l)(i) and (b) of this section, the measure of
liquidated damages assessed shall be as provided
in paragraph (1)(1) of this section for a default of
the agreements in the condition set forth in
paragraph (b) of this section. For purposes of this
paragraph, the phrase ' 'unpaid duties, taxes and
charges" shall include any appropriate ad
valorem fees described in § 24.23 of this chapter,
fees relating to dutiable mail described in §
24.22(1) of this chapter, and harbor maintenance
fees described in § 24.24(e)(3) (i) and (ii) of this
chapter.
(5) If the principal defaults on agreements in the
condition set forth in paragraph (k) of this section
only, the obligors agree to pay liquidated
damages equal to $100 per thousand board feet of
the imported lumber.
[T.D. 84-213, 49 FR41171, Oct. 19, 1984, as amended by
T.D. 88-46, 53 FR 29230, Aug. 3, 1988; T.D. 88-72, 53 FR
45902, Nov. 15, 1988; T.D. 90-92, 55 FR 49884, Dec. 3,
1990; T.D. 93- 37, 58 FR 30984, May 28, 1993; T.D. 96-14,
61 FR 2911, Jan. 30, 1996;
T.D. 96-18, 61 FR 6780, Feb. 22, 1996; T.D. 97-9, 62 FR
8623, Feb. 26, 1997; T.D. 98-56, 63 FR 32945, June 16,
1998; T.D. 00- 87, 65 FR 77815, Dec. 13, 2000]
EFFECTIVE DATE NOTE: By T.D. 01-26, 66
FR 16854, Mar. 28, 2001, in § 113.62,
paragraph (1) (1) is amended by removing
the words '^conditions (a), (g), or (i)''
and adding, in their place, the words
conditions in paragraphs (a), (g), (i),
or (k) of this section'' and by adding the
Chapter Fourteen • Pesticide Import & Export Program • 14-39
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FIFRA Inspection Manual, February 2002
Exhibit 14-12
United States Customs Service, Treasury
Subpart C—Special Permit for
Immediate Delivery
§ 142.21 Merchandise eligible for special
permit for immediate delivery.
Merchandise may be released under a
special permit for immediate delivery,
in accordance with section 448(b), Tariff
Act of 1930, as amended (19 U.S.C.
1448(b)), in the following circumstances:
(a) Contiguous countries. At the discretion
of the port director, merchandise
arriving by land from Canada or
Mexico may be released under a special
permit for immediate delivery provided
the importer has on file a bond on Customs
Form 301, containing the bond
conditions set forth in § 113.62 of this
chapter. An entry summary shall be
filed in accordance with § 142.22(b)(l),
and estimated duties, if any, shall be
deposited, within the time period specified
in § 142.23 for all merchandise from
contiguous countries released under a
special permit except for fresh fruits
and vegetables for human consumption
released under the provisions of paragraph
(b) of this section.
(b) Fresh fruits and vegetables. (1) An
application for a special permit for immediate
delivery may be made for the
transportation of fresh fruits and vegetables
for human consumption arriving
from Canada or Mexico to the importer's
premises within the port of importation,
but removed from the area immediately
contiguous to the border.
(2) The application shall be accompanied
by a continuous bond on Customs
Form 301, containing the bond
conditions set forth in § 113.62 of this
chapter.
(3) The fresh fruits and vegetables
shall be transported to the importer's
premises in the vehicles in which they
crossed the border or, if transshipment
is necessary in vehicles provided by the
importer. The fresh fruits and vegetables
may be examined at the importer's
premises. Those portions without commercial
value may be disposed of in accordance
§142.21 D
with the provisions of
§ 158.11(b) of this chapter, and the balance
shall be entered for consumption
or transported in bond under an entry
for immediate transportation without
appraisement or under an entry for
transportation and exportation.
(c) Agency of U.S. Government. Merchandise
may be released under the immediate
delivery procedure if the shipment
is consigned to or for the account
of any agency or office of the United
States Government, or to an officer or
official of any such agency in his official
capacity, as provided in § 10.101 of
this chapter.
(d) Articles of a trade fair. Articles for
a trade fair may be released under the
immediate delivery procedure, as provided
in § 147.13 of this chapter.
(e) Quota-class merchandise—(1) Tariff
rate. At the discretion of the port director,
merchandise subject to a tariffrate
quota may be released under a special
permit for immediate delivery provided
the importer has on file a bond
on Customs Form 301, containing the
bond conditions set forth in § 113.62 of
this chapter. An entry summary shall
be properly presented pursuant to
§ 132.1 of this chapter within the time
specified in § 142.23, or within the quota
period, whichever expires first. If proper
presentation is not made until after
the tariff-rate quota is filled, the merchandise
shall not be entitled to the
quota rate of duty, and the importer
shall pay duties at the over-quota rate.
(2) Absolute. At the discretion of the
port director, perishable merchandise
of a class approved by Customs Headquarters
which is subject to an absolute
quota may be released under a special
permit for immediate delivery for
removal to the importer's premises, or
to any other location approved by the
port director, until an entry summary
is properly presented pursuant to § 132.1
of this chapter. A proper entry summary
must be presented for merchandise
so released within the time specified
Chapter Fourteen • Pesticide Import & Export Program • 14-40
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§142.22
in § 142.23, or within the quota period,
whichever expires first. If the absolute
quota is filled before the importer
has properly presented an entry
summary, he may either present an
entry summary for warehouse or,
under Customs supervision, export or
destroy the merchandise.
(f) Release from warehouse followed by
warehouse withdrawal for consumption.
Merchandise may be released from
warehouse under a special permit:
(1) At the discretion of the port director
when:
(i) The warehouse is located a considerable
distance from the customhouse
and actual release of the merchandise
from the warehouse may not be effected
within the next full business day
after the day of the payment of duty,
and
(ii) The port has sufficient manpower
to permit such practice;
(2) The importer shall have on file a
bond on Customs Form 301, containing
the bond conditions set forth in § 113.62
of this chapter; and
(3) The immediate delivery permit
shall be annotated to state that a
warehouse withdrawal for consumption
will be filed for this merchandise.
(g) When authorized by Headquarters.
Headquarters may authorize the release
of merchandise under the immediate
delivery procedure in circumstances
other than those described
in paragraphs (a), (b), (c), (d), (e), and
(f) of this section provided a bond on
Customs Form 301, containing the bond
conditions set forth in § 113.62 of this
chapter is on file.
(R.S. 251, as amended, sees. 623, as
amended, 624, 46 Stat. 759, as amended (19
U.S.C. 66, 1623, 1624)) [T.D. 79-221, 44
FR 46821, Aug. 9, 1979, as amended by
T.D. 81-260, 46 FR 49842, Oct. 8, 1981;
T.D. 84-213, 49 FR 41185, Oct. 19, 1984;
T.D. 89-104, 54 FR 50499, Dec. 7, 1989]
§ 142.22 Application for special permit
for immediate delivery.
(a) Form. An application for a special
permit for immediate delivery shall be
made on Customs Form 3461 supported
FIFRA Inspection Manual, February 2002
19 CFRCh. 1(4-1-01 Edition)
by the documentation provided for in
§ 142.3, except that a commercial invoice
shall not be required. Instead of a
commercial invoice, the importer may
deliver to Customs a pro forma invoice,
waybill, or other document setting
forth an adequate description of the
merchandise and the quantities, together
with the values or approximate
values when values are needed for the
purpose of examination. If the merchandise
is to be released under a term
special permit, the documentation also
shall show the term special permit
number, as provided for in § 142.24.
(b) Customs custody. Merchandise for
which a special permit for immediate
delivery has been issued under § 142.21
of this part shall be considered to remain
in Customs custody until the filing
of one of the following:
(1) An entry summary for consumption,
with estimated duties attached;
an entry summary for consumption
without estimated duties attached, if
entry/entry summary information and
a valid scheduled statement date (pursuant
to § 24.25 of this chapter) have
successfully been received by Customs
via the Automated Broker Interface;
an entry summary for warehouse; or an
entry summary for entry temporarily
under bond, which may be filed in any
of the circumstances under § 142.21 of
this part except for merchandise released
from warehouse under §142.21(f)
of this part;
(2) A withdrawal for consumption,
with estimated duties attached, which
shall be filed only for merchandise released
from warehouse under § 142.21(f)
of this part;
(3) An entry for transportation and
exportation, immediate transportation
without appraisement, or direct exportation,
which shall be filed in those circumstances
under § 142.21(b) and (e)(2)
of this part; or entry for transportation
and exportation, or direct exportation,
which shall be filed in the circumstances
under § 142.28 of this part or
(4) An application to destroy, which
shall be filed in those circumstances
under §§ 142.21(b) and (e)(2), and § 142.28
of this part.
Chapter Fourteen • Pesticide Import & Export Program • 14-41
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FIFRA Inspection Manual, February 2002
§142.22
(R.S. 251, as amended, sees. 623, as
amended,624, 46 Stat. 759, as amended (19
U.S.C. 66,1623, 1624))
[T.D. 79-221,44 FR 46821, Aug. 9,1979, as
amended by T.D. 81-260,46 FR 49842, Oct.
8,1981; T.D. 89-104, 54 FR 50499, Dec. 7,
1989]
Chapter Fourteen • Pesticide Import & Export Program • 14-42
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Chapter Fifteen
WARRANTS
Table of Contents
Page
AUTHORITY 15-1
OBJECTIVE 15-1
POLICY 15-1
In General 15-1
Impact of Barlow's Decision on Conduct of FIFRA Inspections 15-2
PROCEDURES 15-3
Obtaining the Warrant 15-3
Contact the U.S. Attorney 15-3
Requirements for Obtaining a Warrant 15-3
Executing the Warrant 15-4
Denial of Entry 15-4
Inspecting With a Warrant 15-5
Returning the Warrant 15-6
Challenges to the Warrant 15-6
Exhibit 15-1: Conduct of Inspections After the Barlow's Decision 15-8
Exhibit 15-2: Model Affidavit in Support of Application for a Warrant 15-17
Exhibit 15-3: Model Warrant 15-19
Chapter Fifteen • Warrants • 15-i
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CHAPTER FIFTEEN
WARRANTS
AUTHORITY
Section 9(b) of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), as amended, authorizes officers or employees, who
have been duly designated by the Administrator, to obtain and
execute warrants authorizing the following:
*• Entry for the purposes of sections 8 and 9.
* Inspection and reproduction of all records showing the
quantity, date of shipment, and names of the consignor and
consignee of any pesticide or device found in violation of
FIFRA at any establishment and, in the event of the inability
of any person to produce records containing such
information, all other records and information relating to
such delivery, movement, or holding of the pesticide or
device.
*• Seizure of any pesticide or device that is in violation of
FIFRA.
OBJECTIVE
To gain entry where lawful entry has been denied for the purpose
of conducting establishment inspections, books and records
inspections, and use/misuse inspections.
POLICY
In General
It is the policy of EPA to obtain a warrant only when all other
efforts to gain lawful entry as authorized under sections 8(b)
(inspection of books and records) and 9 (a) (inspection of
establishments) have been denied. Therefore, the inspector must
be confident that the denial of entry was not the result of his/her
failure to present proper identification, to present a notice of
inspection, or to explain the purpose of the inspection.
If denial of entry occurs because of one of these reasons, the
Chapter Fifteen • Warrants • 15-1
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FIFRA Inspection Manual, February 2002
inspector must correct the problem and again request entry. If
entry is still denied, contact the Regional office to discuss the
feasibility of obtaining a warrant.
Before contacting the Regional office, however, the inspector must
prepare detailed notes giving the name of the person approached,
his/her title, time of denial, reason for denial (if given), and reason
for inspection (i.e., "probable cause" or "neutral administrative
inspection scheme"). This information will be essential when
endeavoring to obtain the warrant.
Note that refusal of entry is not a prerequisite to obtaining a
warrant. A pre-inspection warrant may be obtained where surprise
is desired, the company has a history of prior refusal, or the
distance to a U.S. attorney or a magistrate is so considerable that
excessive travel time would be required if entry were denied.
Impact of Barlow's Decision on Conduct of
FIFRA Inspections
The Supreme Court decision in Marshall v. barlow's Inc., 436 U.S.
307 (1978) affects most government inspections, including any
inspections conducted by State personnel or contractors. In
Barlow's, the Supreme Court held that an OSHA (Occupational
Safety and Health Administration) inspector was not entitled to
enter the nonpublic portions of a work site without either the
owner's consent or a warrant.
The decision protects the owner against any penalty or other
punishment that may arise as a result of his/her insistence upon a
warrant. It also prohibits EPA from imposing sanctions on owners
who insist on a warrant before allowing inspections of the
nonpublic portions of the establishment.
Note that the Barlow's restrictions do not apply to (1) emergency
situations or (2) the inspector's observations of things that are in
"plain view" (i.e., those things that anyone would be in position to
observe).
There are some grounds for interpreting Barlow's as not applying
to FIFRA inspections. For instance, the Barlow's restrictions do
not apply to areas that have been subject to a long-standing and
pervasive history of government regulation - this could include
pesticide establishments. It is Agency policy, however, that FIFRA
inspections must be conducted under the same requirements
applicable to other enforcement programs, including the Barlow's
restrictions.
The Agency has published detailed guidance on the "The Conduct
of Inspections After the Barlow's Decision" (GM-5) (see Exhibit
15-1.).
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PROCEDURES
Obtaining the Warrant
The inspector plays a significant role in seeking a warrant. His or
her knowledge and experience relating to the incident are crucial to
the drafting of warrant documents. Inspectors are responsible for:
(1) obtaining information that specifically describes the premises
that are to be searched; (2) providing specific information with
regard to the items to be seized; and (3) helping to determine which
laws apply or may have been violated.
The inspector also provides the information amounting to
reasonable cause, or supplies the predetermined inspection
schedule that brought him/her to the site.
Regarding all of these items, the inspector should help "cast a wide
net," but one that still is legitimately founded in the facts and the
applicable law. Drafting warrant documents is a particularly
important area where attorneys and inspectors must work as a
team.
Contact the U.S. Attorney
After a decision has been made to obtain a search warrant, the
Regional office will determine whether the inspector, his/her
supervisor, or the Regional attorney must contact the U.S. attorney
of the district in which the property is located. The Regional office
must assist the U.S. attorney in preparing the warrant and any
necessary affidavits. Frequently, the Regional office will prepare
these documents for the U.S. Attorney in advance of meeting with
him/her or the Assistant U.S. Attorney.
Requirements for Obtaining a Warrant
When obtaining a warrant, three documents must be drafted: (1) an
application for a warrant; (2) affidavit in support; and (3) the
warrant itself. Each document must be captioned with the District
Court of jurisdiction, the title of the action, and the title of the
particular document. Exhibit 15-2 is an example of an affidavit
that can be used to support an application for a warrant. Exhibit
15-3 is an example of a warrant that may be prepared for the
magistrate's signature.
The application for a warrant must identify the statute (FIFRA) and
regulations under which the Agency is seeking the warrant, and
identify clearly the site or establishment to be inspected (including,
if possible, the owner and/or operator of the site). The application
must be signed by the U.S. Attorney or Assistant U.S. Attorney.
The affidavits in support of the warrant application are crucial.
Each affidavit must consist of consecutively numbered paragraphs
describing all of the facts that support the issuance of the warrant
(probable cause). If the warrant is sought in the absence of
probable cause, the warrant must recite or incorporate by reference
the neutral administrative scheme that is the basis for inspecting the
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particular establishment. Each affidavit must be signed by
someone with personal knowledge of all the facts stated, although
that person can rely upon "hearsay" or secondhand knowledge. In
a case where entry has been denied, this person would most likely
be the inspector who has been denied entry. Note that an affidavit
is a sworn statement that must either be notarized or personally
sworn to before the magistrate.
The warrant itself is a direction to an appropriate official (an EPA
inspector, U.S. Marshal, or other federal officer) to enter a
specifically described location and perform specifically described
inspection functions. Because the inspection is limited by the
terms of the warrant, it is important to specify to the broadest
extent possible the areas that are intended to be inspected, any
records to be inspected, any sample to be taken, any articles to be
seized, etc. Note, however, that a vague or overly broad warrant
will probably not be signed by the magistrate and may prove
susceptible to constitutional challenge.
The draft warrant must be ready for the magistrate's signature at
the time of submission. Once the magistrate signs the draft
warrant, it is an enforceable document.
Either following the magistrate's signature or on a separate page,
the draft warrant must contain a "return," which is used to report
that the warrant was executed. The return is to be signed and dated
by the inspector after completing the inspection (see "Returning
the Warrant" below).
Executing the Warrant
Warrants are executed only by a physical entry onto the premises.
It is customary to show a possessor a copy of the warrant or
provide a copy, but it is not necessary to serve a warrant. Once the
warrant has been issued by the magistrate or judge, the inspector
may proceed to the facility to begin or continue the inspection. If
more that one person will be conducting the inspection, it is
important that the inspection team members determine each
member's role (i.e., who is going to do what and when) before
going to the facility. The warrant must be executed without undue
delay. The warrant will usually direct that it be executed during
daylight hours and specify the date by which it must be executed.
Denial of Entry
Where there is high probability that entry will be refused even with
a warrant, or there exists a likelihood of threats of violence, the
inspector must be accompanied by a U.S. Marshal, County Sheriff
or local police department officer when executing the warrant. For
reasons of personal safety, the inspector must not attempt forcible
entry of the facility at his/her own initiative.
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If the facility representative refuses entry to an inspector holding a
warrant but not accompanied by a U.S. Marshal, the inspector must
leave and so inform the Assistant U.S. Attorney and the designated
Regional Attorney. They will take appropriate action, such as: (1)
sending the inspector back to the facility, accompanied by a U.S.
Marshal; or (2) seeking a citation for contempt.
Where the inspector is accompanied by a U.S. Marshal, the Marshal
is principally charged with executing the warrant. If a refusal or
threat to refuse occurs, the inspector must abide by the Marshal's
decision whether to leave, seek forcible entry, or take other action.
Inspecting With a Warrant
Except as described below, the inspector must conduct the
inspection strictly in accordance with the warrant. If sampling is
authorized, the inspector must be sure to follow all procedures
carefully, including the presentation of receipts for all samples
taken. If records or other property are authorized to be taken, the
inspector must provide a receipt for the property taken and
maintain an inventory. This inventory will be examined by the
magistrate as part of the return to ensure that the warrant's
authority has not been exceeded and will become an exhibit to the
original warrant when returned to the magistrate or his/her clerk.
Inspectors must keep the following points in mind when
conducting an inspection pursuant to a warrant:
*• As long as the inspection procedures authorized in the
warrant are followed, evidence gathered that may be beyond
the scope of the warrant generally will not affect the validity
of the warrant or of other evidence within the warrant's
scope. The court and the attorneys will decide later whether
a particular piece of evidence must be returned as
improperly taken.
* Pay particular attention to obtaining evidence regarding
authorship, possession, and distribution of facility
documents.
*• Be aware of other possible evidence of wrongdoing. Such
evidence generally is obtainable as long as the inspector has
the lawful authority to be where he/she is. Apply the "plain
view" doctrine, which means essentially that if a piece of
evidence is where it can be seen by anyone in lawful position
or place to do so, it can be collected.
*• The language of the warrant will specify the limits of the
warrant with respect to split samples and provision of
certain documents to the site possessor.
*• As with all inspections, interview as many individuals as
possible. There are no restrictions on asking questions,
although there is no obligation for the facility's
representatives or employees to respond.
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*• The Agency interprets FIFRA as authorizing EPA to
physically remove documents from the establishment and
carry them away, and the magistrate must specifically
authorize removal in the warrant. If for some reason,
removal is not possible or authorized in the warrant, make
provision for copying or photographing the documents on
site or, if necessary, dictate their contents into a machine. If
destruction of the documents by the owner/operator is a real
concern, the documents must be seized if they are essential
to the investigation, regardless of any questions regarding
the scope of the warrant. In such a case, it is better to run the
risk of having the court rule that the documents must be
returned to the possessor than it is to suffer their certain loss.
Returning the Warrant
The return made on a warrant is a written report informing the
court when and where the warrant was executed, who participated,
generally what was done, what items were collected from the
premises (if any), and whether a copy of the warrant was given to
someone (listing the person's name and address).
A return on a warrant is not a certificate or affidavit affirming that
the warrant was "served" on someone. "Service" of a copy of a
warrant is not a requirement to the valid "execution" of the warrant
and is not part of the execution as such.
After the inspection has been completed, the warrant must be
returned to the magistrate. A return of the warrant within the time
restrictions required by the court is essential, because failure to do
so could result in contempt action against the executing officials.
The person who executes the warrant (i.e., the person who
performs the inspection) must sign the return form and give it and
the warrant to the U.S. Attorney, who will formally send the
documents to the issuing magistrate or judge. If anything has been
physically taken from the premises, such as records or samples, an
inventory of such items must be included in the return, and the
inspector must be present to certify that the inventory is accurate
and complete.
Challenges to the Warrant
The possibility always exists that a facility representative will
challenge a warrant and the evidence obtained. The warrant and all
evidence gathered pursuant to it, or portions of evidence obtained
in an otherwise valid warrant, can be overturned by the court.
Some of the typical bases for challenges to a warrant or evidence
(whether or not they are successful) include the following:
*• Insufficient cause for issuance of the warrant.
*• Insufficient affidavit supporting the warrant.
* Inaccurate information in the supporting affidavit.
*• Insufficient description of the premises or items to be seized.
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* Searches beyond the scope of the warrant.
*• Failure to follow appropriate procedures for serving or
returning the warrant.
For a warrant of evidence obtained under it to be successfully
challenged, in whole or in part, usually someone must make a
prejudicial mistake at some point in the warrant process. If the
mistake is serious enough, an entire case could be lost.
There is no reason, however, why this should occur in any case.
The procedures for obtaining, executing, and returning a warrant
are generally well defined and established. Follow them as closely
as possible to ensure successful inspection.
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Exhibit 15-1: Conduct of Inspections After the Barlow's Decision
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
11 APR 1978
MEMORANDUM OFFICE OF ENFORCEMENT
TO: Regional Administrators
Surveillance and Analysis Division Directors
Enforcement Division Directors
FROM: Assistant Administrator for Enforcement
SUBJECT: Conduct of Inspections After the Barlow7s Decision
I. Summary
This document is intended to provide guidance to the Regions in the conduct of
inspections in light of the recent Supreme Court decision in Marshall v. Barlow's, Inc., U.S.
, 98 S. Ct. 1816 (1978). The decision bears upon the need to obtain warrants or other process for
inspections pursuant to EPA-administered Acts.
In Barlow's, the Supreme Court held that an OSHA inspector was not entitled to enter
the non-public portions of a work site without either (1) the owner's consent, or (2) a warrant.
The decision protects the owner against any penalty or other punishment for insisting upon a
warrant.
In summary, Barlow's should only have a limited effect on EPA enforcement
inspections:
• Inspections will generally continue as usual;
• Where an inspector is refused entry, EPA will seek a warrant through the U.S.
Attorney;
• Sanctions will not be imposed upon owners of establishments who insist on a
warrant before allowing inspections of the non-public portions of an
establishment.
The scope of the Barlow's decision is broad. It affects all current inspection programs of
EPA, including inspections conducted by State personnel and by contractors. The Agency's
procedures for inspections, particularly where entry is denied, were largely in accord with the
provisions of Barlow's before the Supreme Court issued its ruling. Nevertheless, a number of
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changes in Agency procedure are warranted. Thus, it is important that all personnel involved
in the inspection process be familiar with the procedural guidelines contained in this document.
This document focuses on the preparation for and conduct of inspections, including (1)
how to proceed when entry is denied, (2) under what circumstances a warrant is necessary, and
(3) what showing is necessary to obtain a warrant.
II. Conduct of Inspections
The following material examines the procedural aspects of conducting inspections under
EPA-administered Acts. Inspections are considered in three stages: (1) preparation for
inspection of premises, (2) entry onto premises, and (3) procedures to be followed where entry
is refused.
A. Preparation
Adequate preparation should include consideration of the following factors
concerning the general nature of warrants and the role of personnel conducting inspections.
(1) Seeking a Warrant Before Inspection
The Barlow's decision recognized that, on occasion, the Agency may wish to
obtain a warrant to conduct an inspection even before there has been any refusal to allow entry.
Such a warrant may be necessary when surprise is particularly crucial to the inspection, or
when a company's prior bad conduct and prior refusals make it likely that warrantless entry
will be refused. Pre-inspection warrants may also be obtained where the distance to a U.S.
Attorney or a magistrate is considerable so that excessive travel time would not be wasted if
entry were denied. At present, the seeking of such a warrant prior to an initial inspection
should be an exceptional circumstance, and should be cleared through Headquarters. If
refusals to allow entry without a warrant increase, such warrants may be sought more
frequently. (For specific instructions on how to obtain a warrant, see Part D.)
(2) Administrative Inspections v. Criminal Investigations
It is particularly important for both inspectors and attorneys to be aware of the
extent to which evidence sought in a civil inspection can be used in a criminal matter, and to
know when it is necessary to secure a criminal rather than a civil search warrant. There are
three basic rules to remember in this regard: (1) If the purpose of the inspection is to discover
and correct, through civil procedures, noncompliance with regulatory requirements, an
administrative inspection (civil) warrant may be used; (2) if the inspection is in fact intended, in
whole or in part, to gather evidence for a possible criminal prosecution, a criminal search
warrant mush be obtained under Rule 41 of the Federal Rules of Criminal Procedure; and (3)
evidence obtained during a valid civil inspection is generally admissible in criminal
proceedings. These principles arise from the recent Supreme Court cases of Marshall v.
Barlow's, Inc., supra; Michigan v. Tyler, U.S. , 98 S. Ct. 1942 (1978); and U.S. v. LaSalle
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National Bank, U.S. , 57 L. Ed. 2d 221 (1978). It is not completely clear whether a
combined investigation for civil and criminal violations may be properly conducted under a
civil of "administrative" warrant, but we believe that a civil warrant can properly be used
unless the intention is clearly to conduct a criminal investigation.
(3) The Use of Contractors to Conduct Inspections
Several programs utilize private contractors to aid in the conduct of inspections.
Since, for the purpose of inspections, these contractors are agents of the Federal government,
the restrictions of the Barlow's decision also apply to them. If contractors are to be conducting
inspections without the presence of actual EPA inspectors, these contractors should be given
training in how to conduct themselves when entry is refused. With respect to obtaining or
executing a warrant, an EPA inspector should always participate in the process, even if he was
not at the inspection where entry was refused.
(4) Inspections Conducted by State Personnel
The Barlow's holding applies to inspections conducted by State personnel and to
joint Federal/State inspections. Because some EPA programs are largely implemented through
the States, it is essential that the Regions assure that State-conducted inspections are conducted
in compliance with the Barlow's decision, and encourage the State inspectors to consult with
their legal advisors when there is a refusal to allow entry for inspection purposes. State
personnel should be encouraged to contact the EPA Regional Enforcement Office when any
questions concerning compliance with Barlow's arise.
With regard to specific procedures for States to follow, the important points to
remember are: (1) The State should not seek forcible entry without a warrant or penalize an
owner for insisting upon a warrant, and (2) the State legal system should provide a mechanism
for issuance of civil administrative inspection warrants. If a State is enforcing an EPA program
through a State statute, the warrant process should be conducted through the State judicial
system. Where a State inspector is acting as a contractor to the Agency, any refusal to allow
entry should be handled as would a refusal to an Agency inspector as described in section
II.B.3. Where a State inspector is acting as a State employee with both Federal and State
credentials, he should utilize State procedures unless the Federal warrant procedures are more
advantageous, in which case, the warrant should be sought under the general procedures
described below. The Regions should also assure that all States which enforce EPA programs
report any denials of entry to the appropriate Headquarters Enforcement Attorney for the
reasons discussed in section II.B.4.
B. Entry
(1) Consensual Entry
One of the assumptions underlying the Court's decision is that most inspections
will be consensual and that the administrative inspection framework will thus not be severely
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disrupted. Consequently, inspections will normally continue as before the Barlow's decision
was issued. This means that the inspector will not normally secure a warrant before
undertaking an inspection but, in an attempt to gain admittance, will present his credential and
issue a notice of inspection where required. The establishment owner may complain about
allowing an inspector to enter or otherwise express his displeasure with EPA or the Federal
government. However, as long as he allows the inspector to enter, the entry is voluntary and
consensual unless the inspector is expressly told to leave the premises. On the other hand, if the
inspector has gained entry in a coercive manner (either in a verbal or physical sense), the entry
would not be consensual.
Consent must be given by the owner of the premises or the person in charge of
the premises at the time of the inspection. In the absence of the owner, the inspector should
make a good faith effort to determine who is in charge of the establishment and present his
credentials to that person. Consent is generally needed only to inspect non-public portions of
an establishment - i.e., any evidence that an inspector obtains while in an area open to the
public is admissible in an enforcement proceeding.
(2) Withdrawal of Consent
The owner may withdraw his consent to the inspection at any time. The
inspection is valid to the extent to which it has progressed before consent was withdrawn.
Thus, observations by the inspector, including samples and photographs obtained before
consent was withdrawn, would be admissible in any subsequent enforcement action.
Withdrawal of consent is tantamount to a refusal to allow entry and should be treated as
discussed in section II.B.3. below, unless the inspection had progressed far enough to
accomplish its purposes.
(3) When Entry is Refused
Barlow's clearly establishes that the owner does have the right to ask for a
warrant under normal circumstances.1 Therefore, refusal to allow entry for inspectional
purposes will not lead to civil or criminal penalties if the refusal is based on the inspector's lack
of a warrant and one of the exemptions discussed in Part C does not apply. If the owner were
to allow the inspector to enter his establishment only in response to a threat of enforcement
liability, it is quite possible that any evidence obtained in such an inspection would be
inadmissible. An inspector may, however, inform the owner who refuses entry that he intends
to seek a warrant to compel the inspection. In any event, when entry is refused, the inspector
should leave the premises immediately and telephone the designated Regional Enforcement
Attorney as soon as possible for further instructions. The Regional Enforcement Attorney
should contact the U.S. Attorney's Office for the district in which the establishment desired to
be inspected is located and explain to the appropriate Assistant United States Attorney the need
for a warrant to conduct the particular inspection. The Regional Attorney should arrange for
inspections are arguably not subject to this aspect of Barlow's. See discussion,
p. 5 and 6.
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the United States Attorney to meet with the inspector as soon as possible. The inspector should
bring a copy of the appropriate draft warrant and affidavits. Samples are provided in the
appendix to this document.
(4) Headquarters Notification
It is essential that the Regions keep Headquarters informed of all refusals to
allow entry. The Regional Attorney should inform the appropriate Headquarters Enforcement
Attorney of any refusals to enter and should sent a copy of all papers filed to Headquarters. It
is necessary for Headquarters to monitor refusals and Regional success in obtaining warrants to
evaluate the need for improved procedures and to assess the impact of Barlow's on our
compliance monitoring programs.
C. Areas Where a Right of Warrantless Entry Still Exist
(1) Emergency Situations
In an emergency, where there is no time to get a warrant, a warrantless
inspection is permissible. In Camara v. Municipal Court, 387 U.S. 523 (1967), the Supreme
Court states that "nothing we say today is intended to foreclose prompt inspections, even
without a warrant, that the law has traditionally upheld in emergency situations". Nothing
stated in Barlow's indicates any intention by the court to retreat from this position. The Regions
will always have to exercise considerable judgement concerning whether to secure a warrant
when dealing with an emergency situation. However, if entry is refused during an emergency,
the Agency would need the assistance of the U.S. Marshal to gain entry, and a warrant could
probably be obtained during the time necessary to secure that Marshal's assistance.
An emergency situation would include potential imminent hazard situations, as
well as, situations where there is potential for destruction of evidence or where evidence of a
suspected violation may disappear during the time that a warrant is being obtained.
(2) FIFRA Inspections
There are some grounds for interpreting Barlow's as not being applicable to
FIFRA inspections. The Barlow's restrictions do not apply to areas that have been subject to a
long standing and pervasive history of government regulation. An Agency administrative law
judge held recently that even after the Barlow's decision, refusal to allow a warrantless
inspection of a FIFRA regulated establishment properly subjected the owner to a civil penalty.
N. Tones & Co., Inc., I.F. & R Docket No. III-121C (July 27,1978). For the present, however,
FIFRA inspections should be conducted under the same requirements applicable to other
enforcement programs.
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(3) "Open Fields" and "In Plain View" Situations
Observations by inspectors of things that are in plain view, (i.e., of things that a
member of the public could be in a position to observe) does not require a warrant. Thus, an
inspector's observations from the public area of a plant or even from certain private property
not closed to the public are admissible. Observations made even before presentation of
credentials while on private property which is not normally closed to the public are admissible.
D. Securing a Warrant
There are several general rules for securing warrants. Three documents have to be
drafted: (a) an application for a warrant, (b) an accompanying affidavit, and (c) the warrant
itself. Each document should be captioned with the District Court of jurisdiction, the title of the
action, and the title of the particular document.
The application for a warrant should generally identify the statutes and regulations
under which the Agency is seeking the warrant, and should clearly identify the site or
establishment desired to be inspected (including, if possible, the owner and/or operator of the
site). The application can be a one or two page document if all of the factual background for
seeking the warrant is stated in the affidavit, and the application so states. The application
should be signed by the U.S. Attorney or by his Assistant U.S. Attorney.
The affidavits in support of the warrant application are crucial document. Each affidavit
should consist of consecutively numbered paragraphs, which describe all of the facts that
support warrant issuance. If the warrant is sought in the absence of probable cause, it should
recite or incorporate the neutral administrative scheme which is the basis for inspecting the
particular establishment. Each affidavit should be signed by someone with personal knowledge
of all the facts stated. In cases where entry has been denied, this person would most likely be
the inspector who was denied entry. Note that an affidavit is a sworn statement that must
either be notarized or personally sworn to before the magistrate.
The warrant is a directions to an appropriate official (an EPA inspector, U.S. Marshal or
other Federal officer) to enter a specifically described location and perform specifically
described inspection functions. Since the inspection is limited by the terms of the warrant, it is
important to specify to the broadest extent possible the areas that are intended to be inspected,
any records to be inspected, any samples to be taken, any articles to be seized, etc. While a
broad warrant may be permissible in civil administrative inspections, a vague or overly broad
warrant will probably not be signed by the magistrate and may prove susceptible to
constitutional challenge. The draft warrant should be ready for the magistrate's signature at the
time of submission via a motion to quash and suppress evidence in Federal District court. Once
the magistrate signs the draft warrant, it is an enforceable document. Either following the
magistrate's signature or on a separate page, the draft warrant should contain a "return of
service" or "certificate of service". This portion of the warrant should indicate upon whom the
warrant was personally served and should be signed and dated by the inspector. As they are
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developed, more specific warrant-issuance documents will be drafted and submitted to the
Regions.
E. Standards or Bases for the Issuance of Administrative Warrants
The Barlow's decision establishes three standards or bases for the issuance of
administrative warrants. Accordingly, warrants may be obtained upon a showing: 1) of
traditional criminal probable cause, 2) of civil probable cause, or 3) that the establishment was
selected for inspection pursuant to a neutral administrative inspection scheme.
1. Civil specific probable cause warrant.
Where there is some specific probable cause for issuance of a warrant, such as an
employee complaint or competitor's tip, the inspector should be prepared to describe to the U.S.
Attorney in detail the basis for this probable cause.
The basis for probable cause will be stated in the affidavit in support of the
warrant. This warrant should be used when the suspected violation is one that would result in
a civil penalty or other civil action.
2. Civil probable cause based on a neutral administrative inspection scheme.
Where there is no specific reason to think that a violation has bee committed, a
warrant may still be issued if the Agency can show that the establishment is being inspected
pursuant to a neutral administrative scheme. As the Supreme Court stated in Barlow's:
"Probable cause in the criminal law sense is not required. For the
purposes of an administrative search, such as this, probable cause
justifying the issuance of a warrant may be based not only on
specific evidence of an existing violation, but also on a showing
that "reasonable legislative or administrative standards for
conducting an ... inspection are satisfied with respect to a
particular [establishment]. A warrant showing that a specific
business has been chosen for an OSHA search on the basis of a
general administrative plan for the enforcement of the act derived
from neutral sources such as, for example, dispersion of
employees in various type of industries across a given area, and
the desired frequency of searches in any of the lesser divisions of
the area, would protect an employers Fourth Amendment rights."
Every program enforced by the Agency has such a scheme by which it prioritizes and schedules
its inspections. For example, a scheme under which every permit holder in a given program is
inspected on an annual basis is a satisfactory neutral administrative scheme. Also, a scheme in
which one out of every three known PCB transformer repair shops is inspected on an annual
basis is satisfactory, as long as, neutral criteria such as random selection are used to select the
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individual establishment to be inspected. Headquarters will prepare and transmit to the
Regions the particular neutral administrative scheme under which each program's inspections
are to be conducted. Inspections not based on specific probable caus must be based on neutral
administrative schemes for a warrant to be issued. Examples of two neutral administrative
schemes are provided in the appendix. (Attachments II and III)
The Assistant U.S. Attorney will request the inspector to prepare and sign an
affidavit that states the facts as he knows them. The statement should include the sequence of
events culminating in the refusal to allow entry and a recitation of either the specific probable
cause or the neutral administrative scheme which led to the particular establishment's selection
for inspection. The Assistant U.S. Attorney will then present a request for an inspection
warrant, a suggested warrant, and the inspector's affidavit to a magistrate or Federal district
court judge.2
3. Criminal Warrants.
Where the purpose of the inspection is to gather evidence for a criminal
prosecution, the inspector and the Regional Attorney should request that the U.S. Attorney seek
a criminal warrant under Rule 41 of the Federal Rules of Criminal Procedure. This requires a
specific showing of probable cause to believe that evidence of a crime will be discovered.
Agency policy on the seeking of criminal warrants has not been affected by Barlow's. The
distinction between administrative inspections and criminal warrant situations is discussed in
Section II.A.2.
2The Barlow's decision states that imposing the warrant requirement on OSHA would not
invalidate warrantless search provisions in other regulatory statutes since many such
statutes already "envision resort to Federal court enforcement when entry is refused".
There is thus some question as to whether the existence of a non-warrant Federal court
enforcement mechanism in a statute requires the use of that mechanism rather than
warrant issuance. We believe that the Barlow's decision gives the agency the choice of
whether to proceed through warrant issuance or through an application for an injunction,
since the decision is largely based on the fact that a warrant procedure imposes virtually
no burden on the inspecting agency. In addition, an agency could attempt to secure a
warrant prior to inspection on an ex parte basis, something not available under normal
injunction proceedings. Several of the acts enforced by EPA have provisions allowing
the Administrator to seek injunctive relief to assure compliance with the various parts of
a particular statute. There may be instances where it would be more appropriate to seek
injunctive relief to gain entry to a facility than to attempt to secure a warrant for
inspection, although at this point we cannot think of any. However, since the warrant
process will be far more expeditions than the seeking of an injunction, any decision to
seek such an injunction for inspection purposes should be cleared through appropriate
Headquarters staff.
Chapter Fifteen • Warrants • 15-15
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FIFRA Inspection Manual, February 2002
F. Inspecting with a Warrant
Once the warrant has been issued by the magistrate or judge, the inspector may proceed
to the establishment to commence or continue the inspection. Where there is a high probability
that entry will be refused even with a warrant or where there are threats of violence, the
inspector should be accompanied by a U.S. Marshal where he goes to serve the warrant on the
recalcitrant owner. The inspector should never himself attempt to make any forceful entry of
the establishment. If the owner refuses entry to an inspector holding a warrant but not
accompanied by a U.S. Marshal, the inspector should leave the establishment and inform the
Assistant to U.S. Attorney and the designated Regional Attorney. They will take appropriate
action such as seeking a citation for contempt. Where the inspector is accompanied by a U.S.
Marshal, the Marshal is principally charged with executing the warrant. Thus, if a refusal or
threat to refuse occurs, the inspector should abide by the U.S. Marshal's decision whether it is to
leave, to seek forcible entry, of otherwise.
The inspector should conduct the inspection strictly in accordance with the warrant. If
sampling is authorized, the inspector must be sure to carefully follow all procedures, including
the presentation of receipts for all samples taken. If records or other property are authorized to
be taken, the inspector must receipt the property taken and maintain an inventory of anything
taken from the premises. This inventory will be examined by the magistrate to assure that the
warrant's authority has not been exceeded.
G. Returning the Warrant
After the inspection has been completed, the warrant must be returned to the
magistrate. Whoever executes the warrant, (i.e., whoever performs the inspection), must sign
the return of service form indicating to whom the warrant was served and the date of service.
He should then return the executed warrant to the U.S. Attorney who will formally return it to
the issuing magistrate or judge.
If anything has been physically taken from the premises, such as records or samples, an
inventory of such items must be submitted to the court, and the inspector must be present to
certify that the inventory is accurate and complete.
III. Conclusion
Except for requiring the Agency to formalize its neutral inspection schemes, and for
generally ending the Agency's authority for initiating civil and/or criminal actions for refusal to
allow warrantless inspections, Barlow's should not interfere with EPA enforcement inspections.
Where there is doubt as to hoe to proceed in any entry case, do not hesitate to call the
respective Headquarters program contact for assistance.
Marvin B. Durning
Chapter Fifteen • Warrants • 15-16
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FIFRA Inspection Manual, February 2002
Exhibit 15-2: Model Affidavit in Support of Application for a Warrant
UNITED STATES DISTRICT COURT
DISTRICT OF
Docket No.
Case No.
In the matter of:
Affidavit in Support of
Application for a Warrant
State of :
County of :
, being duly sworn upon his oath, according to law,
deposes and says:
1. I am duly authorized (title) of the (division) United States Environmental
Protection Agency, Region . I hereby apply for a warrant pursuant to Section 9 of the
Federal Insecticide, Fungicide, and Rodenticide Act, as amended, 7 U.S.C. Section 136 et
seq., for the inspection and/or sampling of the items named below in the possession,
custody or control of the (name of company or owner).
2. This warrant in sought under Section 9 of the Federal Insecticide, Fungicide, and
Rodenticide Act, as amended, (7 U.S.C. Section 136g), which provides:
"(b) WARRANTS - For purposes of enforcing the provisions of this Act and upon a
showing to an officer of court of competent jurisdiction that there is reason to
believe that the provisions of this Act have been violated, officers or employees
duly designated by the Administrator are empowered to obtain and to execute
warrants authorizing -
"(1) entry for the purpose of this section;
"(2) inspection and reproduction of all records showing the quantity, date of
shipment, and the name of consignor and consignee of any pesticide or
device found in the establishment which is adulterated, misbranded, not
Chapter Fifteen • Warrants • 15-17
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FIFRA Inspection Manual, February 2002
registered (in the case of a pesticide) or otherwise in violation of this Act
and in the event of the inability of any person to produce records
containing such information, all other records and information relating to
such delivery, movement, or holding of the pesticide or device; and
3. (Name of establishment, person, or place) is a (describe its business) which the
undersigned compliance officer of the United States Environmental Protection Agency
has reason to believe is in violation of the Federal Insecticide, Fungicide, and
Rodenticide Act, as amended. This belief is based upon the following facts and
information: (summarize the reasons why a violation is suspected and the facts
justifying the suspicions).
4. The (inspection, reproduction of records, sampling, issuance of the stop sale, use or
removal order) will be carried out with reasonable promptness, and a copy of the results
of analyses performed on any samples or material collected will be furnished to the
owner or operator of the subject establishment or property.
5. The compliance officer may be accompanied by one or more other compliance officers of
the United States Environmental Protection Agency.
6. The undersigned compliance officer requests immediate entry to (Name of
establishment or place) to perform the inspection, reproduction of records, sampling, or
the issuance of a stop sale, use or removal order [optional, if necessary].
7. A return will be made to the court at the completion of the inspection, reproduction of
records, sampling, or issuance of a stop sale, use or removal order.
8. The authority of the issuance of the inspection warrant is Section 9 of the Federal
Insecticide, Fungicide, and Rodenticide Act, as amended, and Camara v. Municipal
Court of the City and County of San Francisco, 387 U.S. 523 (1967), See v. City of Seattle,
387 U.S. 541 (1967), and Marshall v. Barlow's Inc., 436 U.S. 307 (1978).
(Name of Compliance Officer)
A Notary Public of
My Commission expires.
Chapter Fifteen • Warrants • 15-18
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FIFRA Inspection Manual, February 2002
Exhibit 15-3: Model Warrant
UNITED STATES DISTRICT COURT
DISTRICT OF
In the matter of: Docket No.
Case No.
Warrant for Inspection, Reproduction of Records, Sampling, and Issuing
Stop Sale, Use or Removal Order of Pesticides or Devices Pursuant to the
Federal Insecticide, Fungicide, and Rodenticide Act, as amended, (7
U.S.C. Section 136).
To (Name) , (Title) , (Division) , Environmental Protection
Agency, Region , and any other duly authorized enforcement officer of said division:
Application having been made and probable cause shown, by (Name of Officer), for inspection
and sampling of packaged, labeled, and released pesticides or devices, as well as labeling and
containers found in the establishment described below; and for inspection and reproduction of
records showing quantity, date of shipment, and the name of consignor and consignee of any
pesticide or device found in said establishment which is adulterated, misbranded, not
registered in the case of a pesticide or otherwise in violation of the Federal Insecticide,
Fungicide, and Rodenticide Act, as amended, or should such records not be available for
inspection, all other available records and information relating to such delivery, movement, or
holding of any pesticide or device which is in violation of the said Act; for the issuance or
surveillance of any stop sale, use or removal order of any pesticide or device which is in
violation of the said Act; all within the establishment or place described as:
(Name of establishment or place)
(Address)
-or-
Application having being made and probable cause shown, by (Name of Officer), for inspection
or sampling of pesticide used in violation of the said Act, at the place described as:
(Name of establishment or place)
(Address)
Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, the federal
regulations promulgated thereunder, and the decisions of Camara v. Municipal Court of the
City and County of San Francisco. 387 U.S. 523 (1967), See v. City of Seattle. 387 U.S. 541 (1967),
and Marshall v. Barlow7s Inc., 436 U.S. 307 (1978) you are authorized to enter (immediately) the
Chapter Fifteen • Warrants • 15-19
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FIFRA Inspection Manual, February 2002
above described premises upon presenting this warrant and therein carry out the inspections,
sampling, reproduction of records, and/or issuance or surveillance of any stop sale, use of
removal order described above.
(Date) (Signature of Magistrate)
RETURN OF SERVICE
I hereby certify that a copy of the within warrant was served by presenting a copy of the same
to (facility owner of agent) on (date) at (location of establishment or place).
(Signature of person making service)
(Official title)
RETURN
Inspection of the establishment described in this warrant was completed on (date)
(Signature of person conducting the inspection)
Chapter Fifteen • Warrants • 15-20
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Chapter Sixteen
SAFETY
Table of Contents
rage
INTRODUCTION 16-1
GENERAL 16-1
Safety Equipment 16-2
Eye Protection 16-2
Foot Protection 16-3
Hand Protection 16-3
Ear Protection 16-4
Nasal, Mouth, and Respiratory Protection 16-4
Head Protection 16-5
Back Protection 16-5
Clothing Protection 16-5
Safety Reminders 16-5
Awareness 16-6
PHYSICAL HAZARDS 16-7
Sampling Trucks and Trailers 16-7
Sampling Rail Cars 16-8
Boxcars 16-8
Hopper Cars 16-9
Sampling Bins and Tanks 16-10
Sampling Bagged or Packed Products 16-10
Sampling Bulk Bagged Products (Large Volume Bags) 16-11
GENERAL SAFETY PRECAUTIONS 16-11
Man-Lifts and Cage-Type Elevators 16-11
Man-lifts 16-11
Cage-Type Elevators 16-11
Ladder Safety 16-11
Lifting Safety 16-12
Machine and Equipment Safety 16-12
Safety Signs 16-12
Electrical Safety 16-13
Hazardous Materials 16-13
Exposure To Hazardous Materials 16-14
Confined Spaces 16-15
Hazards 16-16
Entry and Exit 16-16
Inspector Responsibilities 16-16
Environmental Biological Hazards 16-16
Natural Protection 16-17
How Pathogens Enter The Body 16-17
Common Biological Hazards 16-17
Encountering Biological Hazards 16-20
Protecting Against Environmental Pathogens 16-21
Travel Safety 16-22
Vehicle Safety 16-22
Personal Safety 16-23
Lodging Safety 16-23
Chapter Sixteen • Safety • 16-i
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CHAPTER SIXTEEN
SAFETY
INTRODUCTION
Manufacturing plants, blenders, processors, elevators, mills, and
warehouses can be hazardous work environments. The inspection
of these firms involves working in many potentially hazardous
situations. Since inspectors work alone much of the time, personal
safety must be foremost in their minds at all times. Safety
equipment to ensure maximum protection under any and all
conditions must always be on hand and used when needed or
required. As a professional, be aware of the dangers of the
profession and accustomed to the peculiarities of each
establishment. Exercise care and use common sense at all times.
Personal safety is always more important than any sample.
Accidents may be caused by physical hazards such as faulty
equipment, or they may be caused by human factors such as
complacency, haste, or error. Preventing accidents by eliminating
these causes depends on the willingness of everyone concerned to
conform with known safe practices. Ignorance of safety
instructions is no excuse for their violation. If there are questions
about the safe way to do a job, ask a supervisor for help and
instruction.
The main component of any safety program begins with
preparation and planning.
GENERAL
Note of Advice: The
inspector should be aware
that the wearing of jewelry,
ties, loose flowing clothing,
having long flowing hair, etc.
can pose a safety hazard to
the inspector around
equipment, machinery, etc.
Safety hazards found at various establishments, elevators, mills, and
warehouses may be many and varied. Caution must start at the
main entrance. Vehicular traffic within the plant grounds may not
follow normal movement patterns nor obey usual traffic rules.
Also, the nature and size of equipment used may make it difficult
for the driver to see persons working nearby.
When in the facility, inspectors must make sure management or
employees know where they are going to be. Management
personnel should provide information on possible dangers or areas
Chapter Sixteen • Safety • 16-1
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FIFRA Inspection Manual, February 2002
to avoid during the inspection. Also, inspectors must notify
management where they will be working in case an inspector is
hurt, or in case of an emergency. Follow all safety regulations
required by establishment personnel (no smoking, ear protection
required, etc.).
Safety Equipment
Many products encountered in plants and mills may be corrosive or
destructive to clothing, footwear, or other safety equipment.
Industrial solvents, pesticides, or fertilizers can all eat away
equipment. Regular cleaning, visual checks, and maintenance must
be performed. Several forms of protective or safety equipment are
available for use. A general discussion of the various types or
personal protective equipment (PPE) is presented below.
Eye Protection
Inspectors must use the following types of eye protection
equipment:
> Goggles. Provide an impervious barrier against objects
getting into the eyes because they form a tight seal around
the eye areas. They often may be uncomfortable and hard to
see through because of condensation. Goggles may be
directly vented, indirectly vented, or non vented. Directly
vented goggles may be used for particle deflection. They will
not, however, be impervious to liquids. Indirectly vented
goggles will afford protection from particles as well as most
liquid spatters. Non vented goggles should be used when
dealing with anhydrous ammonia.
* Face shield. The face shield forms a plane of protection in
front of the eyes. The eyes, nose, and mouth can be protected
from direct (perpendicular to the shield) exposure. Objects
or substances coming from other directions, however, may
get into the face or eyes. When not in use, the face shield
may be flipped out of the way to wipe the face. A shield
may also be used easily over prescription glasses. A face
shield affords only secondary protection and must be used
with either goggles or safety glasses.
*• Safety glasses. Safety glasses are available in either dear
lenses or prescription lenses. Like the shield, they do not
afford protection from non direct exposure. Side guards are
available to protect from non direct exposure and must be
used to make them more effective. If glare may be a
problem, tinting may be added.
*• Welding safety. Often construction or welding may be
encountered in the workplace. Be certain not to look directly
at welding. Welding produces bright light and harmful
ultraviolet light. Sparks are also emitted. Stay away from
welding operations and do not look directly at the operation.
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FIFRA Inspection Manual, February 2002
Foot Protection
Types of foot protection include the following:
> Footwear (shoes or work boots). Footwear must first and
foremost be comfortable to wear and provide proper
support. Secondly, it must have a steel toe or protective
support in case objects are dropped on the foot. The sole and
heel of the footwear must be appropriate for the working
environment. Do not wear slick soled shoes, or sneakers.
Footwear must also fit snugly and be supportive. A good
practice is to "waterproof" footwear; this function should be
performed regularly. Regular work boots or shoes are not
suitable when handling or mixing pesticides. Rubber boots
or neoprene boots must be worn. The exposure from these
sources comes from the material soaking up the pesticide
and exposing the person through skin contact. Cases have
occurred where workers have been exposed and became
seriously ill from exposure through shoes or boots. Make
sure proper protective mechanisms are used to prevent your
feet from being exposed to pesticides or caustic chemicals.
*• Rubber boots or galoshes. Rubber boots provide a
protective barrier against water and some solvents. They
also may be easily cleaned. Either "gum" boots, pull over
boots, or buckle boots may be used.
*• Neoprene boots. These boots will afford protection from
various chemicals and solvents.
*• Tyvek booties. These booties can be worn over shoes/boots
and add a large degree of protection from absorption of
chemicals into shoes, boots, and the body.
Hand Protection
When necessary, inspectors must utilize the following to protect
their hands:
Hand protection conies in many forms. The class or material type
of gloves used must be taken into account when selecting the
proper type for use. Certain gloves may have long shanks and
afford protection for the wrist or lower arm. Be aware that cuffs
present a hazard by allowing material to collect in the cuff or may
get caught in machinery.
> Work gloves (cotton or jersey). These gloves will provide
warmth in the winter and some protection from dirt and
blisters. Be careful not to use cotton or cloth gloves when
working with pesticides, chemicals, or solvents. Cloth gloves
will act as a wick and absorb these products, keeping them
in contact with the skin.
* Disposable latex gloves. These gloves are easy to use and
afford protection from some fertilizers, seed treatments, dirt,
grease, non-corrosive materials or liquids. They are easy to
use and readily disposable. One factor to keep in mind is
Chapter Sixteen • Safety • 16-3
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FIFRA Inspection Manual, February 2002
that a few people may be allergic to latex. If a rash occurs,
seek proper medical attention. The disadvantage is that these
gloves do not afford protection against corrosive materials or
certain chemicals. When using latex gloves, determine for
what products the gloves are rated.
*• Heavy rubber gloves. These gloves afford the best
protection when working around pesticides or other similar
products. These gloves are easily rinsed or cleaned when
liquids are spilled on them.
Ear Protection
The following ear protection equipment is recommended:
> Disposable foam plugs. These are inexpensive, easily
stored and used; but they may be uncomfortable to wear.
Make sure the plugs are rated with the proper protection for
the environment you will be working in.
* Padded hearing protectors These are the typical
"headphone" type protectors. They afford both noise
protection as well as a cover for the ear. Usually they are
rated higher than typical plugs and prevent compacting the
ear canal.
Nasal, Mouth, and Respiratory Protection
Inspectors must use the following types of respiratory protection
equipment:
*• Disposable dust masks. These masks are easily worn and
afford little or no protection from pesticides. However, they
may be used for general dust and limited airborne
particulates. Dust masks only prevent particles from passing
through, and offer little or no protection against caustic or
dangerous fumes, pesticides, etc.
* Respirator. Usually respirators contain various filters that
can be interchanged depending upon the hazards of the
working environment. They are rated for particular
substances. Be aware of the respirator's rating and the
protection it affords. Likewise, be aware of the respirator's
limitations. Respirators must never be used in oxygen
deficient environments.
• Note: Facial hair may prevent a tight seal.
• Test according to the manufacturer's directions to ensure
an air-tight seal.
• An air-tight seal, may present a greater problem for women
than for men because man respirators are sized to fit a
man's face. Ensure a tight fit can be achieved prior to
leaving the office.
> Air packs. Self-contained breathing apparatuses (SCBA)
contain a mask, oxygen tank, and regulator. Before using
Chapter Sixteen • Safety • 16-4
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Always Use Safety Devices
and Protective Equipment
FIFRA Inspection Manual, February 2002
SCBA, inspectors must have attended the 40-hour Hazard
Materials Training course and obtained a physician's
approval to wear it. It is extremely important that two
SCBA-trained people be on hand when entering oxygen
deficient environments.
Head Protection
Proper head protection is recommended on most inspections.
Steel or molded hats must be used to protect the head and skull
from falling objects or head height obstacles.
Back Protection
When lifting heavy objects, use a proper back support or a lift belt.
Clothing Protection
Inspectors must use the following to protect clothing:
> Cloth coveralls. Protective outwear is available to be worn
over your normal clothing. Lightweight coveralls can be
used during the summer months while insulated coveralls
can be used in the winter. These coveralls will keep clothing
from receiving stains while in dirty work environments.
*• Tyvek coveralls. Tyvek is an extremely lightweight
disposable "Paper like" substance that is extremely hard to
tear. Tyvek is the preferred material because, unlike cloth, it
does not absorb and, if contaminated, can be discarded.
Inspectors should always have a clean Tyvek coverall for each
inspection (which requires such an item) to prevent cross
contamination of sites and/or samples, etc. It may be necessary to
change solid coveralls frequently at one inspection site.
Also see Respiratory Protection Policy and Procedures.
If there is a need to use a protective device that has not been
supplied or if there are safety concerns, notify a supervisor.
Safely Reminders
Keep in mind the following while conducting inspections:
*• Hardhats must be worn at all times while on manufacturing
and warehouse premises. Prior to entering the plant or
facility, inquire about the firm's safety polices. Many firms
require visitors to wear a hard hat and/or safety glasses.
* Safety shoes with non-slip soles and heels must be worn.
Clothing should be dose fitting. Make sure laces are tied.
> Flashlights must be carried, especially when work
assignments involve the upper floors or basements.
> Dust masks or properly rated respirators must be worn in
dust laden environments.
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FIFRA Inspection Manual, February 2002
*• While in the establishment, make sure equipment is secure
during transit. An ink pen in a shirt pocket may fall out
during the inspection and be incorporated into the firms
equipment or product. A probe, flashlight, or folder may slip
or fall during climbing or conducting the inspection. This
may cause personal injury or injury to other employees.
Awareness
An inspector must not enter a grain elevator, grain mill, warehouse,
railroad tank/car, or silo unless the facility's supervisory personnel
have been alerted as to his/her presence and location where he/she
will be working. Workers in the area should know who an inspector
is and where he/she will be working or planning to work, and what
he/she will be doing. Inspectors must not enter areas where they
have no official purpose.
Plant, elevator, mill, and warehouse fires are not uncommon. Know
the location of exits, telephones, and first aid equipment, and
especially emergency evacuation routes and procedures. Read and
follow all warning signs.
Construction and maintenance work is often being performed
during business operations in all plants. This activity may increase
the possibility of fire or other mishaps. Keep a safe distance from
construction and maintenance activities.
When entering an elevator, mill, or warehouse from bright outside
light, vision may be temporarily impaired. Stop and let your eyes
adjust before continuing the inspection. Be aware of the
surroundings. Avoid stepping on manhole covers since they may
slide from underfoot.
Be conscious of the machinery being used. Observe conditions
surrounding the various products to be sampled, with emphasis on
the danger of front-end loaders, hopper and tank cars, forklifts,
conveyor belts, motor drives, mixers or blenders, welding and
cutting, drag and screw conveyors, falls from heights and electrical
equipment. Stay away from machinery, whether it is operating or
not. The "dead" machinery may be started by a remote control
switch located in another part of the plant. Do not sit or step on a
motionless conveyor belt. Cross over conveyors only on cross
bridges or walk around the belt end.
Watch for wet floors. Dust caused by loading or unloading feed,
fertilizer, or related products can mix with the moisture on the
floors, making them extremely slippery and hazardous.
When the air is dust laden, the ability to see is reduced. This is not
an unusual condition and can be dangerous. In this environment,
protect both eyes and respiratory system with the proper
equipment.
High pressure air lines must not be used to blow dust from
clothing or the body. Foreign matter such as metal fragments, oil,
or water can be blown under the skin or into eyes, causing a painful
or serious injury.
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FIFRA Inspection Manual, February 2002
Grain dust is extremely dangerous, because it is highly explosive.
The grain industry has had damaging explosions with loss of life
and property. There must be NO SMOKING at any time in an
elevator, mill, or facility. Additionally, flash attachments to cameras
or other equipment that generate sparks may ignite a dust
explosion. The key is the concentration of dust in the atmosphere.
Different materials have different explosion concentrations. It is
imperative that inspectors discuss their needs with facility staff
prior to entering a facility with airborne dust concentrations that
might be explosive.
PHYSICAL HAZARDS
Inspect trucks, rail cars, or storage areas and assess their condition.
Be cognizant of fumigant odor; however, remember that some
toxic fumigants have no odor. Rather than take any chances, check
with management to eliminate any risk of exposure. DOT
regulations and pesticide labels usually require that warning signs be
placed on rail-cars containing fumigated commodities. If there is a
fumigant notice on the car, especially if it has a recent date, (3 days
or less), or if you detect a fumigant odor, do not open it. Notify
the firm management to have a qualified person determine if it is
safe to open the car. The firm's qualified person must open the
doors on both sides of the car and allow the car to air out for a
prescribed length of time before allowing anyone to enter.
Remember, some fumigants may not have a detectable odor, but
are still a hazard.
Do not enter trucks, rail cars, or storage areas during the
application of these materials, or enter where the materials have
been applied unless the atmosphere has been certified safe by a
competent person.
Sampling Trucks and Trailers
Sampling around moving trucks and trailers presents a hazardous
working climate. The key factor to prevention of accidents in this
area is alertness. Stay constantly aware of moving vehicles and the
fact that drivers can be careless. The following lists the safe
guidelines for sampling trucks and trailers:
*• Be sure that the driver knows that someone is sampling his
load so that he will not move the truck until sampling is
completed. It may be a good idea to chock or block the
wheels of the truck or trailer.
> Reread Physical Hazards statement regarding fumigants.
*• Use a ladder to get into and out of trailers. If the ladder is
slick, wipe it off with paper towels or a cloth prior to
ascending.
> Always carry or lift probes and other equipment into trucks
and between units. Never toss or throw equipment.
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*• Don't ride on running boards or crawl under trucks or
trailers.
*• Always be alert and watch for moving vehicles.
> On van-type trailers, the driver is required to open doors.
Always check the security of the doors before entering.
> When probing, always be alert for hidden obstructions such
as cross braces and bars as well as the sides and bottom of
the trailers. Hitting such obstructions with a sudden force
can cause serious injuries to your ribs, shoulder, face, or
teeth as well as damage to the trailer and probe. To prevent
such occurrences, do not put weight onto the probe from a
standing or running position.
*• Always be alert for overhead obstacles. Power lines, lights,
building overhangs, and other potential hazards can cause
severe injury. Stay alert.
Sampling Rail Cars
Railroads are always hazardous work environments. Sampling
personnel performing duties on boxcars and hopper cars must be
very careful. Minimize the possibility of an accident or injury by
knowing and observing the rules of safety.
Keep in contact when entering any boxcar or hopper car in a
railroad yard or car siding. Inspectors who are part of a team or by
themselves must be certain that someone is aware of where they are
working and the length of time it will take to obtain the samples.
Different departments may have specific rules regarding the entry
into the box car. Consult a supervisor for all necessary
instructions. Persons that must be notified include:
*• Manager of the plant
> Person in charge of unloading
*• Track-master responsible for the movement of trains
The person or persons notified prior to sampling of boxcars or
hopper cars must also be notified when you are finished.
Railcars to be sampled are classified as either boxcars or hopper
cars. The physical characteristics of the two are completely
different and the hazards involved are unique. Therefore, each will
be covered separately.
Boxcars
First, assess the boxcar's condition. Next, notice the seal that must
be broken. A cutting tool such as side cutters or a pry bar must be
used to cut or break the seal. Wear protective eye wear when
breaking the seal. Seal locking mechanisms often fly apart as they
are broken and may also be sharp and cut hands or skin.
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Opening and closing car doors can be hazardous. When using a pry
bar, push the door away from you. Never stand beside the door; it
may come free of its track and fall.
Note the condition of the grain door and watch for protruding
nails and steel strapping. Place sampling equipment on the door sill
and climb into the car. Never throw sampling equipment into the
car before entering.
Check the inside of the car for protruding nails, bolt heads, etc.
Older boxcars may have wire, rods, or wooden cross braces; use
care not to strike them.
When probing, do not place excessive body weight onto the probe
from a standing position. Rib or shoulder injury may occur if the
material or product is shallow and the end of the probe strikes the
floor.
Use the same care in dismounting from the car as when entering.
Do not throw sample or equipment from the car; it could hit
someone below or damage the equipment or sample.
Hopper Cars
The hopper car is a special purpose type carrier that requires
sampling from the top either through individual hatches or a
continuous opening down the center of the car. Because of its
unique construction and the longer and heavier equipment required
for sampling, it is probably more dangerous to sample than a
boxcar.
The first thing to look for when approaching a hopper car is
electric power lines above or close to the car. Serious injury to
inspectors has occurred as a result of the sampling probe coming in
contact with electric lines. If lines are present, extreme care and
caution must be used during the sampling operation.
Check the condition of the car's ladders. If a ladder is damaged,
loose, or bent, go to the other end of the car and check for a more
secure ladder. Ascend the ladder carefully.
Watch for the approach of a switch engine or switched car while
working atop hopper cars. If, during sampling, the car is moved
and there is no time to get down from (out of) the car, kneel or sit
down to lessen the possibility of falling from the car.
Care must be used in breaking seals. Many lids and hatch covers are
quite heavy and require proper lifting techniques. A back brace will
help prevent injury. When probing is started, care must be taken
not to probe into the sides of the hopper car bottoms; this will
cause the probe to stop suddenly.
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While atop hopper cars, be especially careful if there is spilled,
loose, or wet product or dust. In winter, there may be ice, frost, or
snow. Safety belts are required by OSHA regulations to enter a
hopper car since it is a confined space. It is the inspector's
responsibility to decide whether or not the condition presents such
a hazard as to deem the car too dangerous for sampling at that
time.
High winds during the sampling of a hopper car can blow the hatch
covers on the inspector or blow the inspector or his/her equipment
off of the car. Such conditions are considered too hazardous for
sampling activities.
Never, never, sample a hopper car from above when any partial or
incomplete unloading has occurred. Hopper bins may present a
false "skin" or layer that can break and trap persons attempting to
collect samples. It is a potential deadly situation. Notify the person
in charge of unloading when you are finished sampling.
Sampling Bins and Tanks
Be alert and take proper safety precautions in plants, silos, bins, pits
and any closed areas where bulk products are stored and
asphyxiation hazards exist. If certain products are improperly
stored, improperly handled, or decomposing, dangerous amounts
of carbon dioxide, or other gases may deplete the oxygen supply in
these areas. Closed bins or tanks must never be entered for the
purpose of obtaining probe samples without prior approval of a
supervisor. Prior to bin or tank entrance, it must be determined
that the oxygen content of the bin or tank is sufficient to sustain
life. Fumigated or treated bins or tanks must not be entered until a
"Gas Free Certificate" or an "Entry Permit" (with multiple
confined space requirements) has been posted.
When it is necessary to enter a bin, advise the facility supervisor
and workers in the bin area before entering, and again when the bin
is cleared. Turn-heads, spouts and trippers must not be set for that
bin. Before entering a bin, it must be inspected first from the top
to make sure that no grain is hung up. Do not jump down on top
of the grain - there may be a cavity caused by crusted grain which
could break. Do not enter bins without a proper safety belt. Many
people have lost their lives by entering bins without taking the
proper precautions.
Sampling Bagged or Packed Products
Stay alert when collecting samples during the bagging or packaging
process, and when samples are stored in a warehouse. Loose fitting
jewelry must be removed. Check-weighing requiring the removal of
bags or packages from the line can cause injury. Be alert for the
movement of forklifts used to move the commodity. Stacked
paper or polypropylene bags can shift or may fall easily. When
sampling stacked bags or containers on pallets and a ladder is
required, ensure the ladder provides stable footing before using.
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Sampling Bulk Bagged Products (Large Volume
Bags)
One of the trends in some industries is to go to the large 2,000
pound bags instead of the typical 50 pound package. Frequently,
these bags are transported in a frame and tend to be double lined.
The outside bag is a tough canvas or plastic material while the inner
bag is a simple plastic liner. Typically, theses bags will be six or
seven feet tall and can only be accessed from the top. If a ladder is
needed, secure it with the proper footing before attempting to
sample. Also, be aware that the outer material is slippery and weight
applied to a stack may cause the stack to shift or slip and induce a
hazardous situation.
GENERAL SAFETY PRECAUTIONS
Man-Lifts and Cage-Type Elevators
Most mills and elevators have elevating devices to transport
personnel between working levels. They are normally cage-type
elevator or continuous vertical belt types.
Man-lifts
Never attempt to ride a man-lift without getting the proper
instruction in its operation. When riding an endless belt man-lift,
always take the following precautions:
* Face the belt.
*• Keep feet firmly on the steps.
* Hold on to the hand holds with both hands.
Freight, packaged goods, or sampling equipment must not be
carried or handled on any man-lift. Only tools which fit entirely
within a pocket or tool belt should be carried on man-lifts.
Cage-Type Elevators
The cage-type is similar to a passenger elevator, except much
smaller. When using the cage-type lift, use care to keep door
closed, and operate it per the posted instructions. If there are no
posted instructions, request instructions from elevator or plant
personnel. The maximum load capacity must be posted in the
elevators and observed by all persons using the elevators.
Do not use man-lifts or elevators for emergency evacuation of the
plant. Power failure or shutdown will cause equipment to stop,
possibly trapping occupants.
Ladder Safety
Take the following precautions when using ladders:
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*• Never use a ladder that has cracked rails or rungs or has
slivers on rails.
*• Never use a portable straight ladder that is not equipped
with safety feet, unless the ladder is securely fastened in
place.
*• Always climb and descend a ladder facing the rungs and
rails.
> Do not climb movable straight ladders unless the foot of the
ladder is about one quarter of the ladder length away from
the wall.
*• Use only a ladder for climbing; use of chairs, boxes or other
makeshift ladders invites injury.
> Always use a ladder with safety feet to enter a boxcar or
truck. Do not jump from a boxcar or truck.
Lifting Safety
Never attempt to lift an object that is too heavy to handle alone.
Get assistance to lift heavy objects. When lifting heavy objects,
make sure to follow these safety precautions:
* Get dose to the load.
*• Keep your back vertical, bend your legs.
> Lift slowly, feel the load react through your legs.
> If needed or warranted, use a proper back support and or lift
belt.
Machine and Equipment Safety
When working around machinery, always take the following
precautions:
*• Never attempt to operate any machinery.
*• Never remove a machinery guard or shield on a piece of
equipment while it is running. Guards must never be
removed unless absolutely necessary for equipment
inspection. If guards are removed, steps need to be taken to
ensure the equipment is not started and the guards are
replaced promptly once the inspection is complete. Some
agencies do not permit removal under any condition. If an
emergency arises, be prepared by discussing the topic with a
supervisor.
Safety Signs
Respect all safety signs in the plant; they are posted for everyone's
safety. Failure to obey signs can cause injury. The words "caution"
and "warning" may have been overused but there is a reason for
their use. Pay attention to directions provided.
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Electrical Safety
Never tamper with electrical equipment; electricity can kill quickly.
Hazardous Materials
Chemical compounds are commonly used to control or eliminate
insect infestations in agricultural products or in containers used to
store or transport these products. Such chemical compounds can
present a serious hazard when used in an indiscriminate manner or
when individuals disregard necessary safety precautions through
ignorance or poor judgment. No individual is immune to the
toxicity of these chemicals. There may be many different reactions
to exposure to these toxic chemicals, such as a reduction in the
body's natural resistance that can compound the effect of the
exposure.
Chemical applications to agricultural products or to containers used
to store or transport these products may be separated into three
categories, each offering a different degree of hazard. When
describing a chemical application of a commodity or container,
proper terminology must be used, as it can indicate the degree of
hazard involved in the application.
The following lists the types of hazardous pesticides that are
commonly encountered during pesticide inspections:
> Contact-Type Pesticides. Some active ingredients such as
Malathion and Pyrethrum are contact-type pesticides (i.e.,
their effectiveness depends upon the insects coming in
contact with the material). Contact pesticides can be applied
directly to the commodity or used to eliminate an infestation
within a container. Inspectors must not enter or remain in an
area while these materials are being applied as sprays or
until all vapors or mists have settled from the atmosphere.
Many chemicals have a disagreeable odor. Vapor contact
and absorption through the skin and the vapor or mist
entering the respiratory system can cause ill effects.
> Smoke and Fog Type Pesticides. These pesticides are used
to treat unoccupied residential, greenhouse and commercial
areas, and transportation equipment. Resmethrin, piperonyl
butoxide, pyrethrins, malathion, and didorvous (DDVP) are
among the active ingredients currently used as foggers.
Such areas must not be entered until the time specified in the
Directions for Use has passed. Most fogger propellants are
flammable. See PR notice 98-6: Flammability Labeling
Requirements for Total Release Fogger Pesticides.
> Fumigant Pesticides. The use of fumigants in elevators,
mills, and warehouses is not unusual. If a fumigant or
unidentifiable odor is detected, check with plant personnel
and determine the source of the odor. Fumigants are
hazardous to breathe, even at low concentrations. Spray
treatments of grain and storage areas within facilities,
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elevators and mills are common. Avoid breathing vapor
from sprays. If accidental contact is made, wash area of body
contacted with mild soap and water. Remove and
thoroughly wash clothing, including shoes. Report mishaps
to the supervisor and seek the recommendation of a
physician.
Fumigants are normally liquid or solid chemical compounds which,
when released into the atmosphere, readily turn to the gaseous
State. These products are extremely toxic to man and must be
handled or dealt with using extreme caution. When a commodity
has been fumigated, a percentage of the fumigant is absorbed by
the commodity. This fumigant will be desorbed during the aeration
process at a retarded rate. After a container has been fumigated,
aerated, and resealed, it is possible for a dangerous concentration of
the fumigant to build up within the container. When a certificate is
issued by a competent person, perform the inspection duties within
a two-hour period after testing and issuance of the certificate,
providing that the fumigated area has remained open to the
atmosphere. In the event the two-hour time period has been
exceeded or the container sealed, a new test and certificate by the
competent person is required.
Do not enter storage containers during the application of these
materials or enter a container where the materials have been applied
unless the atmosphere within the containers has been certified safe
by a competent person.
Residues remaining on container surfaces, after the application of
smoke and fog or fumigant type pesticides are more toxic than the
contact-type residues. When performing vessel storage
examinations, inspectors may pick up residue on their hands while
climbing or descending ladders. Do not eat, smoke, or use toilet
facilities until hands are thoroughly washed with soap and water.
Exposure To Hazardous Materials
Indications of exposure to a chemical compound include, but are
not limited to, the following symptoms:
*• Skin irritation (rash, burning sensation, dryness, and
sensitivity).
* Watering of the eyes (also burning sensation).
> Dryness of the nasal passages.
*• Coughing.
* Shortness of breath.
*• Congestion in the chest.
*• Nausea and vomiting.
* Light-headedness.
*• Intoxication.
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*• Ashen complexion.
*• Agitation.
Make sure there is easy access to the emergency telephone numbers
such as police, fire department, medical doctor or hospital, rescue
service, or State or local poison control center. Inspectors must stay
aware of their physical condition and surroundings. Horseplay, in
any form, is dangerous and strictly prohibited.
Do not take chances where chemical compounds are involved.
If the inspector has any reason to suspect that an inspection poses a
potentially harmful or fatal exposure, check with the company's
responsible officer. If, after checking, the inspector still has
concerns about the potential for harm, he/she must not perform
the inspection. Inspectors should consult with their supervisor
when such conditions are found.
Report to a supervisor all injuries no matter how small, as well as
unsafe conditions and unsafe acts that might be the cause of an
accident.
Confined Spaces
Minimum occupational safety and health standards for public
employees who may enter into or work in confined spaces are
found in OSHA regulations at 29 CFR 1910.146.
To be a confined space, the space must:
> Be large enough and so configured that an employee can
bodily enter and perform assigned work.
> Have limited or restricted means for entry or exit.
*• Not be designed for continuous employee occupancy.
* Must meet one or more of the following criteria:
• Contains or has a potential to contain a hazardous
atmosphere.
• Contains a material that has the potential for engulfing an
entrant.
• Has an internal configuration such that a person could be
trapped or asphyxiated by inwardly converging walls or by
a floor which slopes downward and tapers to a smaller
cross-section.
• Contains any other recognized serious safety or health
hazard.
In addition, in any space that meets the above criteria, and has a
depth of 4.5 feet or more from the plane of entry to the plane upon
which the worker will perform their work or when a person's head
or feet pass the plane of entry or any other opening is considered a
confined space.
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Some examples of confined spaces include: Tanks, silos, storage
bins, hoppers, vaults, and pits.
Hazards
Accidents, occupational illness, and fatalities can occur through
asphyxiation, fire and explosion, exposure to substances, falls,
electrocution, and a host of other specific hazards. Since confined
space entry has resulted in more deaths and injury than any other
source in the industry, it is essential to recognize and carefully
evaluate the situation prior to entry.
Flammable atmospheres can result from an enriched oxygen
atmosphere, vaporization of flammable liquids, concentrations of
combustible dust, workplace byproducts or desorption of
chemicals from surface coatings.
Too much oxygen, even several percent above the 20.9 percent
normally found in our atmosphere will cause an increase in the
range of flammability. A flammable atmosphere is created when the
oxygen-combustibility mixture is neither too rich nor too lean for
combustion to occur. If inadequate ventilation occurs, flammable
gasses such as propane, methane, or hydrocarbons can be trapped
in a confined space. Since a number of these vapors or gases are
heavier than air, they sink to the lower level of the confined space.
Combustible dust concentrations can often be found in grain
elevators and silos storage areas.
Entry and Exit
The size of the entry orifice must be taken into account when
considering rescue actions. Barriers to entry, and ladders or the lack
thereof must also be considered. Workers may fall off ladders,
develop claustrophobia or become lodged in the entry orifice.
Inspector Responsibilities
Inspectors must report any hazardous conditions in connection
with confined space entry or any safety equipment defects to the
facility manager immediately. Without exception, no inspector
shall enter a confined space unless it is absolutely necessary,
and only when two or more other persons are present in case
an emergency should arise.
Environmental Biological Hazards
In recent years, increased understanding of environmental
pathogens has impacted the agrichemical industry and medical
field.
Environmental pathogens that can cause disease in humans include
Salmonella, Staphykmccus, E. colt, Histoplasma capsulatum, Cryptococcus
neoformans, Eorsrelia burgdorferi, rabies, and Hantavirus.
The risk of contracting disease from any of these pathogens is
extremely small, especially the more deadly pathogens. Certainly,
steps can be taken to minimize exposure and possible illness from
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these pathogens, no matter how small the risk. Knowing a risk
exists prepares one to deal with that risk in a sensible, responsible
manner and to take the proper steps to minimize the risks to an
individual.
Natural Protection
The world contains many microorganisms. Even today scientists
estimate that most of them have not been studied or identified.
Fortunately, the human body has a series of defenses that include:
> Skin
* Nasal hairs and mucus
*• Cilia in the lungs and the coughing mechanism
*• Stomach acids
> The immune system
How Pathogens Enter The Body
It is important to understand how a disease organism enters the
body in order to understand how best to protect against the various
types of pathogens. The routes of entry into the body include:
* Respiration (inhalation)
* Ingestion
> Skin
* Eyes
*• Sexual activity
*• Ectoparasites
Common Biological Hazards
Each pathogen has its own epidemiology that describes its mode of
transmission, its requirements for development, and the hosts it
must have to complete its development.
*• Salmonella
• A bacterium.
• Present in the surrounding environment, including the soil.
Especially common where decaying food materials are
present.
• Causes food poisoning. Sometimes fatal depending on the
type and lack of treatment.
• Enters the body by ingestion, usually in infected food or
off unwashed hands.
*• Staphylococcus
• A bacterium.
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• Present in the surrounding environment, including the
soil. Especially common where decaying food materials
are present.
• Causes infections in cuts and also in eyes. Severe flesh
necrosis can occur. Fatalities are rare except if the bacteria
enter the bloodstream (septicemia).
• Enters the body through breaks in the skin caused by cuts,
abrasions, and blisters.
E. coli
• A bacterium.
• Present in human and animal feces.
• Causes severe food poisoning, a particular strain not likely
to be encountered, can be fatal.
• Enters the body by ingestion of contaminated food or
from contact with unwashed hands.
Histoplasma capsulatum
• A fungus.
• Present in accumulated bird, chicken, and bat feces in
contact with the soil. The bird feces enrich the soil
allowing the fungus to proliferate.
• Spores become airborne when feces are disturbed.
• Causes respiratory illness (histoplasmosis) and also
blindness. Can be fatal but fatalities are rare.
• Enters the body by inhalation of fungal spores and
through the eyes.
Cryptococcus neoformans
• A pathogenic yeast (fungus).
• Present in accumulated pigeon feces within buildings.
Does not need to be in contact with the soil.
• Spores become airborne when feces are disturbed.
• Causes respiratory illness (cryptocaccosis). Can develop
into cryptococcal meningitis that takes the form of severe
headaches, vomiting, vertigo, and dizziness. Most serious
to persons with existing lung disease, diabetes, Hodgekin's
lymphoma, or leukemia.
• Enters the body by inhalation of fungal spores.
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Hantavirus
• Biosafety Level 4 virus. Twelve different hantaviruses have
been discovered to date but only one type is confirmed to
cause human disease.
• Carried by the white footed mouse or deer mouse,
Pemmyscus maniculatus. Has not been found in house mouse
populations. Other types of hantaviruses have been
isolated from other types of rodents, including the cotton
rat and voles.
• Virus is spread through aerosolized droplets of deer mouse
urine and on microscopic particles of dust infected by
urine or associated with deer mouse droppings. Handling
deer mouse carcasses also poses a risk.
• Causes Hantavirus Pulmonary Syndrome (HPS) which
causes a victim's lungs to fill with fluid, sometimes causing
cardiac arrest. Through 4/16/2001, a total of 283 cases of
HPS had been reported in the U.S. Thirty-eight of all
reported cases resulted in death.
• Deer mice are found most often in areas bordered by
woods and fields. Fortunately, the deer mouse does not
readily infest buildings.
Rabies
• A virus.
• Spread by the bite of an infected animal or by improper
handling of infected animal carcasses.
• In urban areas, skunks, raccoons, coyotes, and dogs are the
primary reservoirs.
• Affects the central nervous system. Always fatal unless
treated.
Borrelia burgdorferi (Lyme Disease)
• A bacterium.
• Carried and spread by various ticks but especially the deer
tick, Ixodes dammini.
• The reservoir in the wild is the deer mouse.
• Causes a myriad of symptoms depending on which body
system is attacked. Attack of the nervous system is the
most serious but can cause arthritic-like symptoms. If
undiagnosed and untreated for too long, damage to the
body may be irreversible.
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*• Insect and Arthopod Stings
• Effects due to venom from bees, wasps, scorpions, and
some ants.
• General swelling and localized reactions are normal.
• Sensitive individuals can lapse into anaphylactic shock
which can be fatal.
*• Spider Bite
• Effects is due to the venom of black widow spiders and
brown recluse spiders.
• Black widow venom affects the nervous system causing
most muscle systems in the body to cramp. Rarely fatal
except in young children and the elderly.
• Brown recluse venom causes collapse of microscopic
blood vessels in area of bite. Lack of blood and nutrients
of affected area leads to tissue death and necrosis.
Secondary Staphylococcus infections can lead to more serious
necrosis and possible to loss of the affected limb.
• Plastic surgery is sometimes necessary depending on the
seriousness and location of the bite.
Encountering Biological Hazards
Walking in and around or crawling beneath a building can bring a
person into contact with pathogens, stinging or biting arthropods
and insects. Rodent, bird, and bat feces can be encountered in any
attic, crawlspace, garage, cellar, basement or unkept feed mills. Bird
feces can be found accumulated on the ground outside and on
rooftops.
Bacteria are everywhere in the soil and on every surface. Pathogenic
bacteria are most likely encountered where animal feces, decaying
food, or decaying animal matter is located. Mishandling rodent or
animal carcasses also brings contact with potentially pathogenic
bacteria.
Histoplasmosis risk is greatest where bird or bat feces have
accumulated in or on top of soil. Cryptococcoses is most likely in
accumulations of pigeon feces in attics, false ceilings, and
warehouses.
Hantavirus contact is most likely in areas where rodent activity is
detected and there is a large amount of droppings and/or the smell
of urine. Attics, closets, storerooms, cellars, basement, garages, and
warehouses must all be suspect in regards to the potential for
encountering mice and other rodents. Hantavirus risk is extremely
low.
Bee and wasp stings can occur at any time during the summer
especially upon accidental stumbling into a nest of these social
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insects. Spider bites can occur when putting on shoes or clothes in
which the spider is hiding or when moving a board, landscape
timber, or other item under which the spider is hiding.
Protecting Against Environmental Pathogens
If proper PPE is not worn, it cannot protect! The proper PPE
needs to be worn by each person who enters areas where
pathogens may be encountered. Items that must be available
include respirator, protective gloves, unvented goggles, Tyvek
coveralls, leather boots/rubber overshoes (or rubber boots),
disinfectant soap, disinfectant sprays, and insect repellent.
The procedures outlined below must be followed to protect against
the most serious environmental hazards. Common sense and
awareness are the best defense in avoiding unnecessary exposure.
* Recognize areas of potential risk, including: numerous
rodent droppings; bird droppings on soil, on floors, in attics,
etc.; excessively dusty conditions; excess decaying food
debris or other decaying organic matter; dead rodents, birds,
or other animals present (presence of blow flies and fly
pupae); evidence of raccoons, possums, or skunks living in
the structure; older buildings.
* Wear a respirator, eye protection, and protective gloves in
suspect environments. Persons who have facial hair (i.e.
beard) will not achieve a tight enough seal with any
respirator.
*• Keep all cuts carefully bandaged, especially on hands. Wear
gloves.
* Spray rodent droppings, rodent nests, and dead rodents
with a disinfectant spray prior to handling or entering a
suspect area. Other dead animals must also be treated with
disinfectant before handling. Use a pump type sprayer to
dispense the product; an aerosol product may disturb small
particles and increase exposure.
* Never attempt to sweep up or vacuum animal droppings as
dust will become airborne. Spray such areas with
disinfectant, let sit for a short period prior to wiping up with
rags or paper towels (if they have to be handled at all).
> Remove and dispose of disposable gloves, Tyvek coveralls,
and booties immediately after exiting the contaminated area.
Continue to wear a respirator and gloves if possible when
removing coveralls as dust on the coveralls could become
airborne.
> Immediately after removing contaminated items, place them
in a plastic bag, spray additional disinfectant solution in the
bag, tightly-seal the bag, and properly dispose of the bag.
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*• Disinfect nitrile, rubber, or latex gloves in an approved
disinfectant solution. Rinse thoroughly.
> While wearing protective gloves, clean the respirator face
piece with disinfectant solution and rinse thoroughly. Store
the respirator in a sealed ziplock type bag.
*• When walking or working in areas where ticks could be
present (wooded areas, tall grass), tuck pant legs into boots
or socks and spray pant legs with insect repellant (unless
taking residue samples). It should be noted that if collecting
samples or entering an area where samples may be collected,
the use of insect repellants may cross contaminate the
sample.
> Avoid entering any area where a dog or wild mammal may
be present. Any animal acting strangely must be avoided.
Travel Safety
Inspectors may be required to travel several thousand miles a year
in order to cover assigned areas or territories. This may be in an
Agency-owned vehicle or in the inspector's own vehicle.
Regardless, a few key safety points or checks will prove valuable in
preventing or minimizing breakdowns and accidents.
Vehicle Safety
Before starting the vehicle, make a quick check of the vehicle's
condition. Especially, pay close attention to the tires. Worn tires,
low tire pressure or punctures in tires may cause blowout while on
the road. Agricultural establishments often will have metal parts,
screws, nails, or similar items in the driveway areas of the firm. As
such, it may be wise to make a visual inspection prior to leaving
inspected firms.
It is also important how equipment is arranged in the vehicle. An
inspector is required to carry a vast amount of equipment and
supplies. This equipment needs to be arranged and secured in case
of a quick stop or collision. In such a case, an unsecured piece of
equipment may act as a projectile inside the car. Therefore,
attention must be paid to how equipment is stored and secured.
Take time and make sure everything is in proper position to avoid
unnecessary risks.
In addition, inspectors may be required to transport hazardous
materials or samples as part of their duties. Ensure that samples are
stored in a manner that would not create a hazard if broken, spilled,
or were otherwise released. Also, vapors from these products may
be dangerous and must not be stored in the passenger
compartment of the vehicle. Hazardous materials must also be
properly packaged to prevent breakage and these packages must be
secured to prevent them from rolling around.
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Vehicle maintenance cannot be overstated. Depending upon EPA
and/or GSA guidelines, make sure to routinely check the
maintenance of the vehicle. Tires, brakes, fluids, hoses, belts, etc.
must all be checked on a regular basis. Inspectors often find
themselves in rural or unpopulated areas. While no examination
will guarantee unwanted breakdowns, there is a good chance of
minimizing them.
Once in the vehicle, always wear a seat belt.
Doors should also be locked while driving. During an accident, an
occupant (even if wearing a seat belt) may be thrown from an open
door. If the door mechanism is locked, there is a better chance that
the door will not fly open.
Keep the vehicle clean. This has two positive dividends. First of all,
from a safety standpoint, windshields and headlights need to be
unobstructed to work or function properly. Also, leftover cups
inside the car may spill or trash may get in the way of the safe
operation of the vehicle. A clean vehicle presents a professional
appearance.
Personal Safety
Always carry a first-aid kit complete with bandages, topical
antibiotic dressings, and antiseptic cleansers. Cuts, scrapes, and
bruises are commonplace when working around equipment. Be
prepared to treat them rapidly and effectively.
It is advisable to keep current with immunizations. Pay particular
attention to tetanus shots and periodical boosters. Discuss with
your physician or the Public Health Service physician potential side
effects of new medications, such as nausea, drowsiness, or ability to
perform your job safely. Read warnings on over-the-counter
medication.
Avoid, if at all possible, becoming involved in a confrontational
situation. If, however, a situation becomes confrontational, the
inspector should exit the inspection site and contact their
management and/or the U.S. Marshal Service, police, etc. Obtain a
warrant before re-entering the site to continue the inspection.
Lodging Safety
When arriving at a motel or hotel, try to park in well lit areas. Be
aware of persons in parking garages and lots. When parked, lock
the vehicle. It is best not to leave any type of valuables in the
vehicle. If valuables must be stored in the vehicle, try to cover or
hide them. Depending on weather conditions (heat and cold), and
for security and to ensure chain-of custody, it may be necessary to
remove samples from the vehicle and store them in the
motel/hotel room or in a secure area.
Be aware of the people in the lobby when checking in. Pay
attention to the surroundings.
Once in the room, pay attention to the security mechanisms
provided. If dead bolt locks and chains are in place, use them.
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Locate the nearest exit in case of fire or an emergency. Usually,
evacuation instructions will be posted in the room. If not, make a
visual check of how to get out safely.
Use the peep hole in the door to visually identify persons knocking
on the door. If the person claims to be a hotel or motel employee,
get the person's name and verify via telephone with the front desk
before letting the person into the room. If the person is indeed an
employee, they will not mind.
Chapter Sixteen • Safety • 16-24
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Chapter Seventeen
APPEARING AS A WITNESS
Table of Contents
rage
OBJECTIVE 17-1
PREHEARING PREPARATION AND PERSONAL APPEARANCE 17-1
GENERAL CONDUCT IN COURTROOM AND VICINITY 17-2
PROPER TECHNIQUE ON THE WITNESS STAND 17-3
THE DIRECT EXAMINATION 17-4
Laying the Foundation For Your Testimony 17-4
Your Testimony 17-4
CROSS EXAMINATION 17-5
PROPER CONDUCT AFTER TRIAL 17-6
EXPERT WITNESS 17-7
Chapter Seventeen • Appearing as a Witness • 17-i
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CHAPTER SEVENTEEN
APPEARING AS A
WITNESS
OBJECTIVE
To assist the EPA witness in presenting an informative,
comprehensive, and credible testimony in civil and criminal
proceedings brought under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) or other federal environmental statute.
These proceedings may be administrative (before an EPA
Administrative Law Judge) or judicial (before a Federal Court
judge).
Under most circumstances, the inspector will be called as a "fact
witness" to testify what personal knowledge they have of the case.
PREHEARING PREPARATION AND PERSONAL APPEARANCE
Prehearing preparation begins when the facility is assigned to you
for inspection. If the case goes to a hearing, certain facts of the
case will come from you. Every detail of your words will be
scrutinized and questioned by the opposing attorney and the court.
The following guidelines must be followed when preparing for a
hearing:
> The EPA attorney assigned to the case will need to have a
thorough knowledge of the facts of the case before any
complaint is filed, and these facts include those uncovered
by your inspection. Make sure that your file is complete, and
that the documents in the file are organized in some fashion
that makes sense. Also go over the facts of the case with the
assigned attorney before any complaint is filed. If you
suspect there are any problems with the evidence in the case,
bring those problems to the attention of your attorney.
> After the complaint is filed and if the matter is set for a
hearing, you must immediately, on becoming aware of the
hearing date, make every effort to meet with the assigned
attorney to determine your involvement in the hearing. Ask
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what the attorney intends to prove by your testimony, and
how the attorney intends to use any documents or items of
evidence that you collected during your inspection.
Clear your calendar for the days you will be needed as a
witness.
Arrange to meet with the attorney before the hearing date
and have him/her go over your testimony and the evidence
you have collected. You may give the attorney valuable
information he/she does not have.
Ask any questions of the attorney at the earliest opportunity.
It will be too late to find out what you are supposed to do
once the hearing begins.
Dress professionally for court appearances. A well-groomed,
neatly attired witness makes a more favorable impression in
the courtroom.
GENERAL CONDUCT IN COURTROOM AND VICINITY
Your conduct must reflect the solemn nature of the
administrative/judicial proceedings. Adhere to the following
guidelines when in and near a courtroom:
> Do not discuss a case with anyone not a part of the EPA
team and then only when you are where no one else can
overhear.
> Do not whisper or talk to another person, or cause any
disturbances in the courtroom.
> If there are jurors, do not talk to the jurors or discuss the case
within their hearing.
* Sit in the seats provided for the spectators but as near the
front as possible. (Your attorney and the court may need to
find you.) If you have to leave the courtroom temporarily,
tell someone where you are in case you are called to the
stand.
> Do not bring magazines or newspapers into the courtroom.
*• Show no incredulity or surprise at any testimony given from
the witness stand or at statements made by the defense
attorney.
> Be on time when court opens and be available immediately
when called to testify.
* If, as a witness, you are not excluded from the courtroom,
listen to the testimony of others. It may trigger a memory or
an interpretation you had not thought of.
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Do not interrupt the attorney while the hearing is in
progress. If you must convey information, write it down and
hand him the note. He will look at it when he can
concentrate. If necessary, he can ask for a recess and talk to
you.
If, as a witness, you are excluded from the hearing room,
leave the hearing room. If you are not excluded, you may
remain. After you testify, always consult the EPA attorney
before you go anywhere or do anything.
PROPER TECHNIQUE ON THE WITNESS STAND
Review this Information
Before Giving Testimony
Proper technique on the witness stand is essential to providing
valuable testimony. The following guidelines must be followed
when giving testimony:
> When called to the witness stand, unless previously sworn,
go directly to the desk of the clerk of the court (or the judge)
to be sworn.
* The judge or clerk will ask you to swear that your testimony
will be true. The answer is "yes" or "I will" depending on
how the oath is worded. If you cannot, in good conscience
"swear under oath," state that you wish to "affirm" your
testimony. Inform the U.S. EPA attorney of this prior to the
hearing.
> Your testimony will be taken down by tape recording or
manual transcription by the court reporter. Your answers to
questions must be made verbally rather than shaking or
nodding your head. Dimensions and directions must be
given verbally rather than demonstrated.
• Sit erectly, but don't appear stiff or tense.
• Always be courteous, say "yes sir/ma'am" and "no
sir/ma'am."
• Speak clearly and distinctly. Don't be rushed. Take your
time.
• Look at and speak to the judge or jury. Speak plainly
enough so that the judge or the farthest juror will hear you.
• The judge may ask you a question from the bench.
Address him/her as "your honor," and answer the
question fully. Otherwise, you may not speak directly to
the judge.
Be factual.
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Do not show hostility toward the defendant or the
opposing counsel. You can lose a case for the government
by losing your temper. You must be objective and
professional.
If you need to use acronyms or technical terms, make sure
you explain what they mean. You must make sure your
attorney knows the terms before the hearing and that the
court reporter knows what they are and how to spell them.
Try to use everyday language when possible.
In your effort to appear impartial and unbiased, do not
become listless or "dead pan." Be natural, candid, frank
and "alive."
Do not appear impatient or overly anxious to testify.
Do not have anything in your mouth. This includes gum,
toothpick, tobacco, candy, or food.
Keep your hands away from you mouth, face, and head.
Attempt to minimize nervous tendencies, such as arranging
clothes, tie, etc.
THE DIRECT EXAMINATION
Direct examination is answering questions asked of you by the
government attorney. The following guidelines are applicable to
both direct and re-direct examination. You must know before the
hearing every question your attorney will ask you on direct, and
every answer you will give before you take the stand.
Laying the Foundation For Your Testimony
The first question you will be asked is to identify yourself for the
judge. You will be asked about your job and your qualifications to
do whatever you will testify you did for this case.
The next set of questions will show the judge the area of your
testimony and give him/her an idea of the facts of the case.
Questions usually begin broad and move to the more specific.
Listen to what you are being asked.
Your Testimony
When giving testimony under direct examination:
*• Always tell the truth.
*• Answer only the question asked. Do not volunteer
additional information.
*• Do not be afraid to say, "I don't know" or "I don't
understand the question," if indeed you do not know the
answer. This answer must never be used to be evasive. You
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may be qualified as an "expert witness" but this does not
mean you are infallible; you can only answer the questions
to the best of your ability.
Never use the word "indicate" to describe a communication
made to you by anyone. This word is quite ambiguous, and
unnecessary. It causes a witness to look like he or she is
hedging in their testimony. People do not "indicate"
anything to you. People tell you something, or state
something to you, or nod their head in one manner or
another, or point to something. Be specific in telling the
judge or jury how the person you are talking about
communicated information to you.
Do not give personal opinions.
Do not be hesitant about using your notes to refresh your
memory and you must do so in cases of complicated figures,
dates, etc.
If you do refresh your memory from notes, the defense has
the right to examine them and make them an exhibit in the
case.
Occasionally the other attorney will stand up and object to
something being asked of a witness. If this happens while
you are on the stand, stop talking and listen to what the
judge says. He/she will tell you to answer the question or tell
the attorney to change the question. If you have forgotten
the question, ask to have it repeated.
CROSS EXAMINATION
Cross examination is done by the opposing counsel asking you
questions. The following guidelines are applicable to both cross and
re-cross examination:
> The instructions regarding your testimony (listed previously
under "Direct Examination") are equally important when
testifying under cross examination.
* Under cross examination, you will likely be subject to more
vigorous questioning than you were under direct
examination.
*• The other attorney may try to confuse you or get you angry -
that is what he/she is being paid to do. Try not to allow the
other attorney to succeed at this attempt.
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If the attorney challenges your truthfulness, your credentials,
your ability to do your job, or your professional conclusions,
remember this is good defense strategy and do not play into
his/her hands by getting angry or insulted. Answer the
question. Your professional performance on the stand will
bolster your credibility.
If the cross examiner attempts to confuse you with rapid
questions you must:
• Answer him/her deliberately and at a comfortable pace.
• Ask him/her to repeat or restate any unclear or confusing
question.
Do not attempt to be argumentative with the cross examiner
if he/she interrupts your testimony. The U.S. or EPA
Attorney must make an objection to the judge if the
interruption is not warranted. The government attorney will
often allow you to clarify or elaborate on a point on redirect.
If the attorney's question to you is actually several questions
rolled into one, point that out before answering, and proceed
to answer the questions one at a time. If necessary, ask the
attorney to restate the question.
Beware of questions to which the cross-examiner demands a
"Yes" or "No" answer to a question if such an answer will
not reveal the entire truth. Beware of hypothetical questions
that require you to draw a conclusion that you are not
comfortable with. Do not agree with the opposing attorney
just to get him/her to stop badgering you.
If the cross-examiner should misquote any of your earlier
testimony when asking a question, you should correct the
misquote before answering the question.
If you make an error while testifying, correct it at the first
opportunity. If you discover the error after you have
completed your testimony and have been dismissed as a
witness, discuss the matter with the government attorney. If
you are caught in an error, admit it and explain it if possible.
PROPER CONDUCT AFTER TRIAL
After the trial, continue to conduct yourself in a manner that will
bring credit to you and the Agency.
If there is occasion to speak to the defendants, be courteous
regardless of their demeanor. Do not discuss your testimony or the
merits of the case with them even after the hearinv is over.
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If you can, stay and hear testimony of others. You may hear
problems or good points that the government attorney misses.
Write down your thoughts or questions you think the attorney
must raise and give them to him/her at a recess.
EXPERT WITNESS
In a hearing the term "expert" is a legal term meaning a person
who has skill, experience or extensive knowledge on certain
subjects. It does not mean this person is the best in his field or has
a PhD.
If the government intends to offer you as an "expert," the attorney
is satisfied that you have the requisite knowledge. Often your
experience is what qualifies you as an expert.
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Chapter Eighteen
FIFRA CRIMINAL ENFORCEMENT
Table of Contents
Page
INTRODUCTION 18-1
THE CRIMINAL PROVISIONS OF FIFRA 18-1
THE STATE AND FEDERAL ROLES IN CRIMINAL ENFORCEMENT
OF FIFRA 18-2
FIFRA'S RELATIONSHIP TO OTHER FEDERAL CRIMINAL LAWS 18-2
OVERVIEW OF CRIMINAL ENFORCEMENT 18-3
Special Attention to Defendant's Rights 18-3
Criminal Enforcement at EPA 18-3
RECOGNIZING POTENTIAL CRIMINAL VIOLATIONS 18-4
Criminal Enforcement Compared to Civil Enforcement 18-5
Searches 18-5
Compelling the Production of Information 18-6
Charging the Commission of a Crime 18-6
Discovery 18-6
Burden of Proof 18-7
Penalties 18-7
Criminal Investigations 18-8
Initiating an Investigation 18-8
Conducting a Criminal Investigation 18-8
Security of Criminal Investigations 18-9
Parallel Criminal and Civil Proceedings 18-9
Compliance with the Jencks Act 18-10
Participation in Grand Jury Investigation 18-11
CASE STUDIES 18-11
Case Study No. 1 18-11
Case Study No. 2 18-12
Case Study No. 3 18-12
Chapter Eighteen • FIFRA Criminal Enforcement • 18-i
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CHAPTER EIGHTEEN
FIFRA CRIMINAL
ENFORCEMENT
INTRODUCTION
Over the past several years, EPA's criminal enforcement program
has become a significant tool in enforcing environmental
requirements. The success of the criminal enforcement program
has increased incentives for voluntary compliance by the regulated
community.
EPA's criminal investigations are handled by Special Agents of the
Criminal Investigation Division (CID). Other key members of the
criminal enforcement program include the Regional Criminal
Enforcement Counsel (located in each Office of Regional Counsel)
and the Office of Criminal Enforcement Counsel (located at EPA
Headquarters in Washington, D.C.). In addition, many States have
instituted their own environmental criminal enforcement programs.
FIFRA inspectors are among the pesticide enforcement personnel
most likely to initially detect criminal environmental violations.
Any such discoveries can be discussed with either EPA's Special
Agents or Criminal Enforcement Counsel. A formal referral
memorandum or "package" is not necessary to obtain an
assessment of the potential criminal implications of a FIFRA
violation. Many environmental criminal investigations and
prosecutions can trace their beginnings to a single telephone call by
an alert inspector.
The Federal Law Enforcement Training Center (FLETC) in
Glynco, Georgia, can provide special training for interested FIFRA
inspectors (and other environmental technical personnel) who are
involved in criminal investigations. The purpose of this chapter is
to heighten FIFRA inspectors' awareness of the environmental
criminal enforcement program and the critical role they play in this
program. In addition to the overview in this section, special
considerations related to criminal investigations are noted, where
appropriate, throughout this manual.
THE CRIMINAL PROVISIONS OF FIFRA
Section 14(b) of FIFRA (7 U.S.C. section 1361) makes the knowing
violation of any provision of FIFRA punishable as a crime subject
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FIFRA Inspection Manual, February 2002
to criminal penalties consisting of fines and/or a term of
imprisonment. More severe criminal penalties are provided for
convicted defendants who are pesticide registrants, applicants for
registration, pesticide producers, and commercial applicators than
for private pesticide applicators.
Section 12 of FIFRA (7 U.S.C. section 136J) specifically lists the
unlawful acts that are subject, not only to civil and administrative
enforcement, but also to criminal investigation and prosecution. A
FIFRA inspector must be alert to the fact that the commission of
any of these unlawful acts may potentially represent a criminal case.
THE STATE AND FEDERAL ROLES IN CRIMINAL ENFORCEMENT OF
FIFRA
Sections 26 and 27 of FIFRA (7 U.S.C. sections 136w-l and
136w-2) provide that a State shall have primary enforcement
responsibility for pesticide use violations during any period for
which the Administrator determines that such State: (1) has
adopted adequate pesticide use laws and regulations, and (2) has
adopted and is implementing adequate procedures for the
enforcement of such State laws and regulations. The States are
initially allowed 30 days to commence appropriate enforcement
actions for such violations. Criminal FIFRA violations, though,
that do not constitute pesticide use violations can be investigated
and prosecuted on the federal level without waiting for State
authorities to exercise their primary enforcement responsibility.
FIFRA'S RELATIONSHIP TO OTHER FEDERAL CRIMINAL LAWS
Any FIFRA inspector who uncovers what he or she believes to be
any type of criminal environmental offense must bring this fact
promptly to the attention of their EPA supervisor and in turn,
notify the EPA criminal enforcement counsel or Special Agents or
appropriate State authorities. This is true even if it does not appear
to be a FIFRA violation. Criminal environmental conduct may also
be prosecuted under one of the other environmental laws or one of
the general criminal laws.
Submission of false information as part of registration may, for
instance, not only constitute a violation of FIFRA, but also of the
federal false statement statute and conspiracy laws. The unlawful
disposal of pesticides may be a criminal violation of the Resource
Conservation and Recovery Act (RCRA) or if the disposal was into
a river, such conduct could amount to a criminal violation of the
Clean Water Act (CWA). Which statute to proceed under many
not be decided until the investigation is almost completed and may
depend on factors such as the evidence available to establish an
offense and the different penalty levels of the involved statutes.
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OVERVIEW OF CRIMINAL ENFORCEMENT
Special Attention to Defendant's Rights
Investigations of alleged criminal activities place even greater
responsibilities on the participants involved. Because more severe
penalties may be imposed on individuals convicted of violating the
criminal provisions of environmental laws or other statutes, there
are greater constitutional safeguards to protect their rights. Thus, it
is of critical importance that all participants in criminal
investigations be fully aware of these safeguards and conduct
themselves accordingly. Special Agents of the Criminal
Investigation Division (CID) provide the necessary instructions
and directions to the investigation team on these matters.
From the beginning of a criminal investigation until it is completed,
the constitutional rights of defendants must be fully protected and
established investigation procedures must be followed. The special
emphasis given to these matters results from the potential
defendant's desire to conceal his or her criminal activities and,
when detected, their frequent challenges to the procedures used to
apprehend them and to seize evidence of their criminal misconduct.
These challenges to the government's case principally stem from
the "Exclusionary Rule," which prohibits the use of evidence
during the prosecution of a defendant whose constitutional rights
were violated by the procedures used to collect that evidence. Also
excluded is any information subsequently derived from improperly
collected evidence. The procedures used by EPA's CID are
designed to ensure protection of the defendant's rights and leave a
documentary record of the investigation that will support
admission of the resulting evidence into a prosecution.
Another frequent procedural challenge occurs when a suspect
provides statements to a law enforcement officer, after being taken
into custody. The Special Agent must first issue a "Miranda
Warning" and obtain a knowing waiver of such rights if the
statements are to be admissible evidence. Defendants also have a
right against self-incrimination. This means that a defendant can be
silent and make the government prove its case.
Criminal Enforcement at EPA
The criminal investigative staff is a part of the Office of Criminal,
Enforcement, Forensics, and Training (OCEFT) in Washington,
D.C. with Special Agents operating out of field units at all Regional
offices. In addition, EPA technical personnel, such as engineers
and field inspectors, have received special training to assist the
criminal investigative staff when needed. As environmental
criminal enforcement has expanded, increasingly joint
investigations are conducted involving the EPA and other federal
enforcement agencies (such as the FBI, Fish and Wildlife Service,
and U.S. Customs) and with State enforcement offices.
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The Agency has a staff of attorneys experienced in both criminal
and environmental law who work with the investigators and DOJ
in the investigation and prosecution of criminal cases. Located at
EPA Headquarters and within the Offices of Regional Counsel,
they provide legal guidance and training in criminal enforcement
matters. An inspector must not hesitate to contact any Special
Agent or Criminal Enforcement Counsel to discuss any aspect
(general or specific) of the criminal enforcement program.
RECOGNIZING POTENTIAL CRIMINAL VIOLATIONS
It is neither expected nor desired that FIFRA civil inspectors and
investigators be able to define or even that they attempt an in-depth
legal or investigatory analysis of whether criminal conduct has
occurred or is occurring at regulated sources. These issues are
complex and even the highly trained Special Agents in the CID
usually do this in consultation with DOJ and EPA Criminal
Enforcement attorneys.
Nevertheless, it is important that all acts of the regulated
community exhibiting actual or suspected environmental criminal
conduct be referred to the CID for review and possible
investigation. The FIFRA inspector is an indispensable person in
initially uncovering and/or identifying pesticide violations that may
warrant criminal enforcement action.
The problem is, how does one recognize those actions that may
potentially constitute criminal violations? How does one recognize:
> Knowing or willful behavior - defined as criminal under all
federal statues?
> Fraudulent reporting - defined under all statutes and the
U.S. code as criminal behavior?
Evidence of criminal wrongdoing is seldom blatant, and usually is
quite subtle. The FIFRA inspector must try to learn as much as he
or she can when one of the types of findings listed below puts up a
red flag of the possibility of criminal actions, and the Special Agent
or Criminal Enforcement Counsel must be consulted. The
following is exemplary only:
> Conflicting Data. Two sets of books, inconsistent
monitoring reports on the same incident.
*• Conflicting Stories. When an inspector is led to believe one
thing and sees something quite different in records or
through observation.
*• Unsubstantiated Data. Monitoring or other record keeping
and reporting information which lacks any record or
information to support reported information should raise
suspicion.
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*• Deliberate Actions. When an employee says he was told to
do something the FIFRA inspector knows is illegal.
*• Claims of Ignorance About Requirements. Documentation
displaying knowledge is discovered in records, or others
make statements during interviews disclosing knowledge.
If any of these problems are in evidence, or others are present that
make the inspector suspicious, he or she must attempt to obtain
further information through interviews, observations, and records
reviews and promptly consult with the CID about such findings.
Criminal Enforcement Compared to Civil
Enforcement
This manual focuses primarily on procedures and techniques for
collecting evidence that may ultimately lead to a form of
administrative or judicial civil action. Generally, these same
procedures and techniques are employed in criminal investigations
as well. There are several exceptions, however, the most important
of which are in the areas of search and seizure and compelling
testimony. Because of the unique sensitivities and legal issues
involved, FIFRA inspectors assisting in criminal investigations
must always follow the instruction of the Special Agent (and
enforcement attorney).
Searches
Criminal Investigators/Special Agents may search a person or the
person's property when seeking evidence of alleged criminal activity
only under the following circumstances: (1) with the person's
consent; or (2) after obtaining a warrant based upon sworn
testimony that demonstrates the existence of "probable cause" to
believe that a crime has been committed and that the search is
necessary to obtain evidence of the crime. The probable cause
standard for obtaining a warrant in a criminal investigation is far
more stringent than for a warrant in a civil enforcement case.
EPA's Special Agents seek and execute criminal warrants, but
FIFRA inspectors may be requested to accompany criminal
investigators to aid in the investigation. In such cases, instructions
of the criminal investigator must be strictly followed since any
evidence collected outside the authority of the search warrant
would be illegally obtained.
It is important to point out, however, that evidence of a crime
discovered through civil enforcement activity is generally
admissible in court to prove the crime. For example, information
collected by a FIFRA inspector during a routine inspection (with
consent or in an administrative warrant) could be admitted as
evidence in a criminal case provided it was lawfully obtained during
his or her normal course of duties. Similarly, evidence of a crime
obtained in accordance with the "open field" doctrine (e.g., an
observation of illegal pesticide use from a public road) would also
be admissible.
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Inspectors frequently ask how the reading of "Miranda rights"
applies to the facility staff they interview, particularly if the
interviewee's answer to questions begins to suggest that there may
be criminal activity. Miranda rights only apply when a person is in
custody, that is, once he or she has been arrested. Information
provided in routine interviews is lawfully obtained evidence that
may be used in furtherance of a criminal investigation and
prosecution.
Compelling the Production of Information
In addition to obtaining evidence through a search warrant, a
prosecutor may subpoena witnesses to provide information
through testimony to a grand jury. Although someone may be
subpoenaed to require him/her to provide information in a civil
proceeding, the prosecutor's ability to compel information in a
criminal investigation is more powerful:
> A witness who fails to appear in response to a subpoena is
subject to immediate arrest.
*• An uncooperative witness can be forced to provide
information through an enforceable court order.
> Testimony provided to a grand jury for long-established,
compelling policy reasons is secret, with severe penalties for
anyone who violates that secrecy. (These rules of grand jury
secrecy severely limit what can be disclosed by an agent
concerning an investigation).
Persons subpoenaed for a civil proceeding are obligated as follows:
*• If a witness fails to comply with a subpoena, penalties can
only be obtained after a hearing (a process that can take
weeks).
* In addition, the information provided by the witness cannot
be kept confidential if it falls within the scope of the other
side's discovery requests.
Charging the Commission of a Crime
Unlike in a civil judicial case where an agency files suit, or a civil
administrative case where an agency issues an administrative order,
it is the grand jury or U.S. Attorney who charges persons or
corporations with crimes. A grand jury brings a charge by
returning an "indictment," which generally is issued for felonies
(e.g., crimes subject to punishment by imprisonment for longer
than one year). The U.S. Attorney brings a charge by filing an
"information," which generally is used in connection with
misdemeanors (i.e., crimes subject to punishment by imprisonment
for one year or less).
Discovery
The general rule in criminal cases is that there is minimal discovery
permitted by the defendant but there are exceptions to the rule.
For example, case law requires a prosecutor to give to the
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defendant before the trial any exculpatory evidence (evidence that
may show innocence) known to the prosecutor. A number of rules
similar to this have been the basis for a few courts to adopt an
open file policy. It allows counsel for the defendant to access the
prosecutor's entire file. Defendants in criminal cases, however,
cannot file interrogatories or request for admissions, or take
depositions of witnesses, as they can in civil cases. Defense
counsel may attempt to learn information about the government's
case by directly contacting an inspector. While an inspector is not
prohibited from communicating with defense counsel, it should be
noted that the inspector is in no way required to talk to defense
counsel. Inspectors that may be contacted about a pending
criminal matter are strongly encouraged to consult with an agent or
enforcement counsel first.
Burden of Proof
Because criminal sanctions can be severe, the burden of proof is
greater in a criminal prosecution than it is in a civil enforcement
case. To prove a violation in a civil enforcement case, the
enforcement attorney is required only to show that a
"preponderance of the evidence" is on his or her side (sometimes
described as needing 50 percent of the material evidence on the
government's side). To prove a criminal violation, a prosecutor
must prove his or her case "beyond a reasonable doubt." If a
reasonable doubt exists in the trier of facts mind about the
defendant's guilt after the conclusion of a criminal case, the
defendant must be acquitted.
Penalties
A person convicted of criminal violations of an environmental
statute may be imprisoned and/or fined and, perhaps of greater
consequence, suffer the societal stigma that is attached to criminal
conviction. A person found through civil enforcement action to
have committed a violation is subject only to injunctive relief
orders, and/or financial penalties.
All individual defendants convicted of environmental criminal
offenses that occurred after November 1987, will be sentenced
pursuant to the new sentencing guidelines adopted to achieve
uniformity in all sentences for federal trial courts nationwide. The
sentencing guidelines for offenses involving the environment will
increase both the likelihood of a minimum amount of
imprisonment and the dollar amount of the fine imposed for
knowing wrongdoing causing harm to the environment or
endangering public health.
In addition, to make probation a meaningful and effective criminal
sanction, the Office of Criminal Enforcement, Forensic, and
Training has compiled a list of all individual and organizational
defendants who are placed on probation and the length of such
probation. Inspectors must familiarize themselves with the list to
ensure that convicted criminal environmental violators are
sufficiently monitored so that they do not repeat their criminal
activity.
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Criminal Investigations
Initiating an Investigation
An "initial lead," or allegation of potential criminal activity, may
come to the Agency from any of several sources, including State
agencies, routine compliance inspections, citizens, and disgruntled
company employees. Regardless of the source of the tip, whoever
receives the tip must immediately notify the
Special-Agent-in-Charge (SAIC) in the Region. The SAIC will
evaluate the lead and, if necessary, assign a Special Agent for follow
up, assign a case number, and open an investigative file.
If the reliability of the lead is unclear, the Special Agent will
conduct a preliminary inquiry to determine the credibility of the
allegation and make an initial assessment for the need of a more
thorough investigation. This initial inquiry is brief and involves no
extensive commitment of resources or time. The purpose is to
reach an initial determination of the need for a complete
investigation. The agent may consult with program enforcement
personnel and legal staff to help determine whether a particular
violation warrants criminal enforcement action.
During the course of a routine inspection, FIFRA inspectors are in
a unique position to follow such leads. Inspectors must be alert to
possible criminal activities such as falsified information in records
and reports and illegal pesticide use. Facility staff employees may
also volunteer information to inspectors about possible criminal
activities.
Conducting a Criminal Investigation
If after the preliminary inquiry a decision is made to pursue a
thorough investigation, the Special Agent contacts the Office of
Regional Counsel and other appropriate offices to determine
whether any civil enforcement action is pending or contemplated
against the investigative target. If technical support for the
investigation is needed, as it increasingly is as criminal cases
become more complex, the Special Agent asks the appropriate
Regional Program Division Director(s) to designate specific
individuals to work on the investigation. All these activities are
carried out in consultation with the Office of Enforcement
Compliance, Enforcement, Forensics, and Training.
The Special Agent manages the investigation, under the supervision
of the SAIC, and is responsible for the following:
*• Determining the basic investigative approach.
* Leading in conducting interviews.
> Assembling and reviewing records.
*• Planning and performing surveillance.
*• Coordinating with the U.S. Attorney's office and other
federal, State, and local law enforcement agencies.
*• Communicating with informants.
Chapter Eighteen • FIFRA Criminal Enforcement • 18-8
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FIFRA Inspection Manual, February 2002
*• Contacting other witnesses.
*• Performing other investigative functions.
* Completing all required reports.
* Carrying out all coordination and notification requirements.
Inspectors may be assigned to assist the Special Agent in one or
more of these above duties.
Security of Criminal Investigations
Information on criminal investigations must be provided only on a
"need-to-know" basis. Active criminal investigations must not be
discussed with personnel outside of the Agency, except as is
necessary to pursue the investigation and to prosecute the case.
Agency policy is to neither confirm nor deny the existence of a
criminal investigation. If a FIFRA inspector receives a request for
information from the news media, it must be referred to the Special
Agent, who will determine the response in consultation with other
Agency offices.
Written materials pertaining to the investigation must receive
special care and attention. The CID criminal investigative offices
and enforcement division offices are equipped with secure office
space, filing cabinets, and evidence vaults. Similar security
measures must be used by Regional staff assigned to an
investigation.
Parallel Criminal and Civil Proceedings
While FIFRA inspectors do not routinely become involved in
criminal investigations, the distinction between civil and criminal
enforcement is often unclear and inspectors may find themselves
associated (directly or indirectly) with a criminal investigation.
Sometimes, while pursuing a criminal action, the Agency will also
conduct a civil action if the environmental consequences of a
violation pose a hazard requiring remedial measures by a defendant.
When there are parallel criminal and civil enforcement actions
relating to the same violation, it is important that the distinction
between the two be clear to ensure that the government not be
liable to claims of misusing criminal investigative processes for civil
enforcement purposes and vice versa. There are five rules of thumb
a FIFRA inspector will follow when involved in ongoing parallel
proceedings:
* Civil/administrative and criminal enforcement actions may
be conducted simultaneously whenever deemed necessary
by the EPA Assistant Administrator for the Office of
Enforcement and Compliance Assurance in order to seek
immediate relief to protect human health or the
environment.
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*• Until the Agency refers a matter to the Department of Justice
for possible criminal prosecution, all EPA employees must
continue to collect information (data) from potential
defendants with the understanding that it may be used in
either a civil or a criminal enforcement action.
*• No EPA employee shall ever tell a person or entity from
whom information is being sought that it will not be used by
the Agency as evidence in a criminal prosecution.
*• Once the Agency has referred a matter to the Department of
Justice for possible criminal prosecution, all FIFRA
inspectors and other EPA employees who continue to collect
information/data from potential defendants (unless acting as
an investigator for the prosecutor's office or CID) must have
a clear need to obtain such data for an existing regulatory
purpose that is wholly separate and independent of the
criminal investigation.
* Questions concerning any issue relating to parallel
proceedings can be answered by criminal enforcement
counsel at Headquarters or in the Office of Regional
Counsel.
Compliance with the Jencks Act
The purpose of the federal Jencks Act is to allow the defendant in a
criminal prosecution to have, for impeachment purposes, all of the
relevant and competent statements of a governmental witness. If
the defense's ability to cross-examine a witness is impeded because
the government lost, either deliberately or inadvertently, the Jencks
Act material, the Court may decide either not to allow the witness
to testify or to strike the witness's entire testimony. Needless to
say, the effect of excluding a government witness's testimony could
be significant. Courts expect law enforcement agencies, including
EPA, to have procedures to preserve potential Jencks Act Material.
Essentially, the Jencks Act provides that the relevant notes, records,
and reports of a witness who has testified for the government in a
criminal prosecution must be turned over to the defense if the
defense requests them through the court. The request can only be
made after direct examination of the witness, and material that does
not relate to the subject matter of the testimony is exempt. The
effect is limited, after-the-fact discovery. (In civil cases, discovery
processes give the other side almost unlimited access to
government information on the case prior to trial.)
For the inspector, the principal effect of the Jencks Act is to
underscore one of the major points of this chapter - that accurate
and complete notes, records, and reports are not only good
practice, but essential. Further, notes and records must be factual,
Chapter Eighteen • FIFRA Criminal Enforcement • 18-10
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containing no opinions or biases of the inspector. Finally, to avoid
any potential appearance that Jencks Act material has been lost, the
inspector must throw nothing away not even a scrap of paper with
rough calculations on it. All materials associated with a criminal
investigation must be stored in accordance with security
procedures.
Participation in Grand Jury Investigation
With rare exception, federal grand juries are used to develop EPA's
criminal cases following referral to DOJ. Frequently, EPA
employees, including inspectors, attorneys, and technical personnel,
assist in these grand jury investigations under DOJ supervision.
The conduct of Agency employees is frequently subjected to close
judicial scrutiny, since defense attorneys routinely challenge aspects
of the grand jury presentation during motions filed after an
indictment. Accordingly, Agency employees who assist DOJ
during the criminal investigations must be familiar with, and abide
by, the rules of conduct established by case law and the Federal
Rules of Criminal Procedures.
When involved in grand jury investigations, any EPA employee
must follow the "Agency Guidelines for Participation in Grand
Jury Investigations." Copies are available from the Regional
Counsels and the Office of Enforcement and Compliance
Assurance.
CASE STUDIES
The following are examples of how pesticide violations led to
environmental criminal prosecutions:
Case Study No. 1
EPA's Regional office was alerted by a competing pesticide
manufacturer that a firm was selling an algicide without an EPA
Registration Number. The Region referred the allegation to the
State Department of Agriculture. The State inspector confirmed
the sale of the unregistered pesticide and had a stop sale order
issued. After new allegations concerning the sale of the pesticide
and submission of false pesticide reports to both the State and
EPA, a federal search warrant was obtained and executed at the
company. Evidence substantiating the false labeling of pesticides
and the repeated sale of unregistered pesticides was seized.
The criminal investigation resulted in guilty pleas by the company,
its president, and vice-president to federal charges of selling in 10
States unregistered pesticide products in knowing violation of
FIFRA. The company was fined $70,000, the vice-president
$10,000, and the president was sentenced to two months in jail. All
were placed on probation for a period of five years.
Chapter Eighteen • FIFRA Criminal Enforcement • 18-11
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Case Study No.2
As an act of spite in an ongoing dispute with his neighbors, a
farmer disposed of waste pesticides, including lindane, parathion,
strychnine, endrin, and dieldrin on the bank of a river used by his
neighbors for recreational and farm use. An emergency cleanup was
undertaken by the State.
EPA and State environmental officials jointly decided to handle the
matter as a criminal violation of the federal hazardous waste statute
since more severe penalties were then available than under other
federal or State laws.
Case Study No.3
Two commercial pesticide applicators were arrested on State
charges of operating without a license and federal charges of
misuse. These applicators operated separate unlicenced structural
pest control businesses for at least three years, applying restricted
use agricultural pesticides indoors and distributing unlabeled
pesticides in food and beverage containers. One of the commercial
applicators was found guilty of 21 FIFRA misdemeanor counts of
pesticide misuse, and the other commercial applicator was found
guilty on all 48 counts of pesticide misuse. The commercial
applicators were sentenced to 5 and 6 Vz years in prison,
respectively. These convictions represent the longest sentence in
the U.S. for an exclusively environmental crime.
Chapter Eighteen • FIFRA Criminal Enforcement • 18-12
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Chapter Nineteen
RESTRICTED-USE PESTICIDES: DEALER AND APPLICATOR
RECORD INSPECTIONS
Table of Contents
PageD
AUTHORITY 19-1
OBJECTIVES 19-2
POLICY 19-2
RUP Dealer Records 19-2
Sales to Certified Applicators 19-2
Sales to Uncertified Persons 19-3
RUP Applicator Records 19-3
PROCEDURES 19-3
RUP Dealer Inspection 19-4
RUP Applicator Inspection 19-4
Chapter Nineteen • RUP: Dealer & Applicator Record Inspections • 19-i
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CHAPTER NINETEEN
RESTRICTED-USE
PESTICIDES: DEALER
AND APPLICATOR
RECORDS
INSPECTIONS
AUTHORITY
Section 11 of FIFRA and 40 CFR Part 171 require dealers and
commercial applicators to maintain records of sales, distribution,
and application of restricted-use pesticides (RUPs).
Section 8(b) of FIFRA provides the authority to inspect and to
copy records.
Section 9 (a) of FIFRA provides the basic authority for
establishment inspections.
Section 12(a)(2)(B) makes it unlawful to refuse to allow any entry,
inspection, copying of records, or sampling that is authorized by
this Act.
This chapter provides direction for inspections conducted under
federal authority in States and in Indian Country where there are
federally conducted programs. Federal inspectors can, however,
under the authority of section 8(b) of FIFRA conduct Dealer
Record inspections in States and Indian Country that have federally
delegated enforcement programs. Section 8(b) of FIFRA States
that any producer, distributor, carrier, or dealer shall, upon request
Chapter Nineteen • RUP: Dealer & Applicator Record Inspections • 19-1
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FIFRA Inspection Manual, February 2002
of any officer or employee of the EPA, furnish all records showing
the delivery, movement or holding of pesticides. Since many State
pesticide laws, including record keeping, are more extensive than
FIFRA, federal inspectors must familiarize themselves with the
State's pesticide laws prior to conducting these inspections. In
cases where State violations are documented the file must be
forwarded to the respective State for their follow up or
enforcement action.
OBJECTIVES
Inspections are conducted to determine dealer and applicator
compliance with FIFRA record keeping requirements regarding
sales, distribution, and application of RUPs and to ensure that
RUPs are sold only to certified applicators or non-certified persons
for application by a certified applicator who is specifically certified
for the use of the particular RUP.
POLICY
In addition, establishment inspections and/or use investigations
may be conducted in accordance with procedures described in
Chapters Seven and Twelve of this manual. Records maintained by
dealers and commercial applicators who distribute and use
restricted-use pesticides will be reviewed for compliance.
RUP Dealer Records
RUP dealers are required to maintain two primary types of sales
records, which are subject to Agency review: (1) sales to certified
applicators and (2) sales to uncertified persons. The following lists
the information that is required in 40 CFR 169.3(b) and 171.11(g).
Sales to Certified Applicators
Records of each transaction must be retained for 24 months and
must include the following information:
> Name and address of each certified person to whom the
pesticide was made available for use.
* Certified applicator's Certification Number, expiration date,
certification categories, and name of State or other
governmental unit issuing the certificate.
> Product name, EPA registration number, and State Special
Local Need registration number on the pesticide label.
*• Amount of the pesticide made available for use in the
transaction.
*• Date of the transaction.
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Sales to Uncertified Persons
Transaction records must be retained for 24 months and must
include the following information:
> Name and address of the uncertified person to whom the
pesticide was made available for use by a certified
applicator.
*• Name and address of the certified person who will use the
restricted-use pesticide.
*• Certified applicator's Certification Number, expiration date,
certification categories, and name of State or other
governmental unit issuing the certificate.
> Product name, EPA registration number, and State Special
Local Need registration number on the label of the pesticide.
*• Amount of pesticide made available for use in the
transaction.
*• Date of the transaction.
RUP Applicator Records
Commercial applicators and those who contract with commercial
applicators to apply RUPs to property owned by another person
must maintain applicator records for at least 24 months from the
date of pesticide use and they shall include the following
information [40 CFR 171.11(c)(7)]:
*• Name and address of the person for whom the pesticide was
applied.
*• Location of the pesticide application.
* Target pests.
* Specific crop or commodity and site to which the pesticide
was applied.
* Date and time of application.
*• Trade name and EPA registration number of the pesticide
applied.
> Amount of pesticide applied and percentage of active
ingredient per unit of pesticide used.
*• Disposal information.
PROCEDURES
At the beginning of a records inspection, the inspector must follow
routine procedures of identifying and notifying the owner,
operator, or agent-in-charge of the establishment as outlined in
Chapters Seven and Twelve of this manual.
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FIFRA Inspection Manual, February 2002
RUP Dealer Inspection
The inspector must check for dealer reporting to EPA (40 CFR
171.11 (g)) or State license expiration date and record dealer license
number, if applicable. The inspector must determine whether the
dealer is selling or has sold any RUPs and whether the dealer is also
an applicator of restricted-use pesticides.
Records must be reviewed to determine compliance with FIFRA
and to ascertain whether all the previously listed required
information is being maintained. Any deficiencies must be
documented, (e.g., through photocopies and/or photographs,
affidavits, statements, etc.).
RUP dealers' stocks must be inspected and RUPs inventoried. The
inspector must document the following situations:
* Sales to non-certified persons or for use by non-certified
persons.
> Discrepancies between physical inventories and transactions
(Books and Records Inspection including computer
inventories).
> Improperly labeled products, including agricultural
pesticides lacking Worker Protection (WPS) label statements.
*• Suspended or canceled products sold and/or held for sale
and distribution.
> Damaged products and any corrective actions taken.
> Improperly stored products.
RUP Applicator Inspection
The inspector must check the Certified Applicator's Certification
Number, certification categories, and expiration date.
Records must be reviewed to determine compliance with FIFRA
and to ascertain whether all the previously listed required
information is being maintained. Any deficiencies must be
documented(e.g., through photocopies and/or photographs,
affidavits, statements, etc.).
Pesticide stocks must be inspected and RUPs inventoried. The
inspector must document the following occurrences:
*• Discrepancies between physical inventories and amount
used (Records Inspection).
> Improperly labeled products, including agricultural
pesticides lacking Worker Protection (WPS) label statements.
*• Suspended or canceled products being held for use.
> Damaged products and any corrective actions taken.
> Improperly stored products.
> Improper disposal of container, excess pesticide, and
rinsates.
Chapter Nineteen • RUP: Dealer & Applicator Record Inspections • 19-4
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Chapter Twenty
PREPARING INSPECTION REPORTS
Table of Contents
Page
INTRODUCTION 20-1
PURPOSE OF WRITTEN REPORTS 20-1
Communicate 20-1
Provide a Basis for Compliance Determination/Action 20-1
FIVE STEPS IN WRITING A NARRATIVE REPORT 20-2
Step 1 - Plan 20-2
Step 2 - Organize the material 20-2
Step 3 - Write 20-2
Step 4 - Evaluate 20-2
Step 5 - Rewrite 20-3
Essentials of Good Reports 20-3
CBI CONSIDERATIONS 20-4
REPORT FORMAT 20-5
Exhibit 20-1: FIFRA Establishment Inspection Report 20-6
Exhibit 20-2: Example of Separate Memorandum of Inspector's Findings 20-9
Exhibit 20-3: FIFRA Use Investigation Report 20-10
Chapter Twenty • Preparing Inspection Reports • 20-i
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CHAPTER TWE NTY
PREPARING
INSPECTION REPORTS
INTRODUCTION
The inspector is EPA's "eyes and ears" to the regulated
community. The information gathered is the foundation for U.S.
EPA's enforcement program, but unless what the inspector
discovered can be documented, organized, and communicated,
their knowledge is of little value. The inspector must be able to
prepare clear, objective, and well-documented written reports.
PURPOSE OF WRITTEN REPORTS
Communicate
The main purpose of a written inspection report is to clearly and
concisely communicate a complete and factual record of the
inspection process to the reader, from the opening conference,
through the inspection/collection of samples, to closing
conference. To communicate effectively, the report must be
readable and inspire confidence in the reviewers.
Provide a Basis for Compliance Determination/
Action
The inspection report must contain enough
information/documentation about the inspection to enable a Case
Review Officer to determine: (1) the facility's compliance with
FIFRA, and (2) that the inspector followed statutory requirements
for presenting credentials, issuing a Notice of Inspection with a
reason for the inspection, properly collecting evidence, and issuing
a Receipt for Samples. If enforcement action is warranted, the
inspection report must contain all the elements necessary to
support any alleged violations. If an inspection report is not
complete or accurate, time and resources may be wasted trying to
remedy the short falls.
Chapter Twenty • Preparing Inspection Reports • 20-1
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FIFRA Inspection Manual, February 2002
FIVE STEPS IN WRITING A NARRATIVE REPORT
Step 1 - Plan
A good inspector begins to plan his/her report the day the
inspection begins. By thinking about how the facts must be
reported ahead of time, the inspector can improve both the quality
of the inspection report as well as the inspection itself.
Step 2 - Organize the material
All information gathered during the inspection must be collected
and reviewed, including inspection report forms and checklists, for
relevance and completeness. The field notebook and/or inspection
checklists are useful tools for developing the narrative report, but
cannot replace a narrative report. Any identified gaps in the
information must be resolved by follow-up telephone calls or
inspections. The material must then be organized in the order it
will be presented in the report.
Step 3 - Write
While writing the inspection report, keep the following in mind:
*• Write to express, not to impress. Only relevant facts and
evidence necessary to prove the compliance or violations of
the site being inspected must be included in the inspection
report.
* State complicated matters in simple direct terms.
* Keep the reader in mind. When preparing an inspection
report, assume that the reader knows nothing about the case
except what is in the report. The report must construct a
complete and accurate picture of the entire inspection, step
by step.
Step 4 - Evaluate
After the report has been written, review the report from the
viewpoint of the reviewer and answer the following questions:
* What is the report trying to communicate?
> Has the report fulfilled the purpose of the investigation?
*• Can supervisors and reviewers make correct decisions based
on this report?
*• Does it answer the questions - who, what, when, where,
why, and how?
*• Are any further inquiries necessary?
*• Is it readable?
> Is it fair, concise, complete, accurate, and logical?
* Is any part ambiguous?
Chapter Twenty • Preparing Inspection Reports • 20-2
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FIFRA Inspection Manual, February 2002
Proofread the report to check for inconsistencies, unnecessary
repetition, tone, omissions, and typographical errors.
Step 5 - Rewrite
Correct those portions of the narrative that were identified as
needing improvement.
Essential of Good Reports
> Fairness. The reports must be entirely objective, impartial,
unbiased and unemotional. Convey facts so they speak for
themselves. Rumors, gossip, offensive remarks or language
should be avoided. To test for fairness, read the material
aloud to ensure the report is conveying the proper tone for
the reader and the purpose of the report.
* Accuracy. The information must be stated precisely and
accurately in plain language. The inspection report must
not, under any circumstances, include the inspector's
conclusions regarding compliance or noncompliance. The
goal is to present the facts so dearly that there will be no
need for conclusions. If the inspector wants to communicate
certain findings or observations to the reviewer, these
opinions must be contained in a memorandum separate
from the inspection report. In an enforcement case, the
entire inspection report is subject to discovery by the
opposing side. If conclusions of law or opinions are in the
report, it may weaken the inspector's credibility by
suggesting bias. In addition, the inspector may have been
wrong about a violation which U.S. EPA did not pursue.
This would be revealed through discovery and could also
weaken the inspector's credibility. A separate memorandum
of findings or conclusions will usually be protected from
discovery based on attorney-client privilege.
* Completeness. Include all information that is relevant.
Completeness implies that all known facts have been
reported either in the text or as an attachment, so that no
further explanation is needed. The report must be tested to
ensure that it answers the questions "who, what, how, when,
where, and why."
*• Sources of evidence. Always report the source from whom
the information or samples were obtained. Ensure that the
source has been identified with his/her job title under section
III. Participants, in Exhibit 20-1: FIFRA Establishment
Inspection Report.
* Attachments. The report will consist of a narrative portion
with appropriate attachments. The attachments will support
and document not only that the inspector followed statutory
Chapter Twenty • Preparing Inspection Reports • 20-3
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FIFRA Inspection Manual, February 2002
requirements but also will indicate a facility's compliance
status. Attachments must always be referenced
parenthetically in the narrative portion of the report and
consecutively numbered in the order that they are
mentioned.
Facts Indicating Weaknesses in the Case. Explanations from
the individuals being interviewed or important facts that
point to weaknesses in the case should not be omitted.
Subsequent disclosure of facts indicating weaknesses that
were known by the report writer but not disclosed may
compromise any potential enforcement action by the
Agency. Disclosure of any potential weaknesses in the
report will give reviewers an opportunity to plan a course of
action.
Conciseness. Conciseness is never omitting facts, details or
necessary explanation, but the removal of all that is elaborate
or non-essential. Conciseness is not what is said, but how it
is said. Use short sentences with active verbs and paragraphs
whenever possible.
Clarity and Logical Presentation. The report must be
written dearly in order to avoid misinterpretations. Writing
takes time and effort. Order thoughts; select those most
useful to the reader; arrange them logically; and select the
words that will best convey the thoughts to the reader.
CBI CONSIDERATIONS
For the most part, the information that an inspector may encounter
during an inspection that is considered Confidential Business
Information (CBI) under FIFRA is the annual pesticide production
report required under section 7 of FIFRA. Only federal employees
may be cleared to view or collect this report during an inspection.
Those portions of the report that contain CBI must be treated in
accordance with FIFRA CBI procedures.
State employees conducting inspections under the authority of
FIFRA are not cleared to see or handle FIFRA CBI information.
Therefore, State inspectors must not ask to see or collect any CBI
information as an official sample during an inspection. Some
information to be obtained during these inspections may be
claimed as FIFRA confidential business information (CBI). If the
question should be: (1) only provided to the State inspector on a
consensual or voluntary basis and only after the State informed the
establishment they are not cleared to view, obtain, or copy FIFRA
CBI or (2) if claimed FIFRA CBI, request the responsible company
official to send the information/documents directly to the Regional
FIFRA Document Control (DCO). The inspector should provide
the responsible company official with a listing of all requested
documents/information to be sent to the Regional office.
Chapter Twenty • Preparing Inspection Reports • 20-4
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FIFRA Inspection Manual, February 2002
REPORT FORMAT
The inspection report consists of a narrative report with several
attachments. The format of the report may vary, but the content
must include at a minimum, the information listed in the report
outline in Exhibit 20-1.
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FIFRA Inspection Manual, February 2002
Exhibit 20-1: FIFRA Establishment Inspection Report
Establishment Name
Street Address
[Mailing Address]
City, State Zip Code
Date of Inspection
Month Day, Year
Performed by:
U.S. Environmental Protection Agency
Pesticides & Toxic Substances Branch
77 West Jackson Boulevard
Chicago, Illinois 60604
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FIFRA Inspection Manual, February 2002
I. Company Information
A. Company Name
B. Establishment Registration Number
C. Responsible Official(s) (Full name, title, and telephone numbers)
D. Type of Ownership
II. Date of Inspection
III. Participants in the Inspection
A. Company
B. U.S. EPA/State/Tribe
IV. Inspection Objectives
V. Company Background
VI. Inspection Summary
A. Opening Conference
B. Inspection Observations and Sample Collection
C. Closing Conference
VII. Index of Attachments
A. Standard Forms
1. FIFRA Notice of Inspection
2. Receipt for Sample
3. Chain of Custody
B. Evidence
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FIFRA Inspection Manual, February 2002
1. Photographs
2. Copy of Label on Physical Sample
3. Copies of Records
a. Records of Inbound Shipments
b. Production Records
c. Inventory Records
d. Shipping Records
4. Bin Labels/Labeling
5. Statements
6. Laboratory Analysis
(Inspector's Name), (Title) Date
Pesticides and Toxics Enforcement Section
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Exhibit 20-2: Example of Separate Memorandum of Inspector's Findings
ENFORCEMENT SENSITIVE
FIFRA Establishment Inspection
Compliance/Non-Compliance Based on Findings and Observations
Case Number:
Inspector: (Inspector Name), (Title)
Date of
Inspection: Month, Day, Year
Company: Name
Street Address
[Mailing Address]
City, State Zip Code
Inspection/Investigation Findings and Observations:
Based on the information received during ...
(Inspector's Signature), (Title) Date
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Exhibit 20-3: FIFRA Use Investigation Report
FIFRA Use Investigation Report
I. Persons Involved
(for example)
A. Complainant/Address/Telephone Number
B. Certified Applicator/Company Name/Address/Telephone Number
C. Suspected Violator/Company Name/Address/Telephone Number
II. Circumstances
A. What Happened and Where
B. How and What was Reported
III. Chemical Information (EPA Reg. No., brand name, specific language on the label
that involves the investigation)
IV. Investigation
A. Investigator's Activities in Sequential Order
B. Statements (who, when, and what)
C. Mapping/Photographs (where, what)
D. Sampling (what type of sample(s) were collected and where, what analyzed
for)
E. Records (sales or application)
F. Weather Data (what records were obtained, from whom, date obtained, what
do the records show)
V. Attachments
Chapter Twenty • Preparing Inspection Reports • 20-10
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APPENDIX A
FIFRA PESTICIDE
SAMPLING
PROCEDURES
One of the essential parts of an inspection is the proper sampling
and documentation of pesticide products being formulated or
marketed by a firm. The inspector must properly collect, prepare,
and document the sample in order for it to be admissible as
evidence of a violation. All samples will be either physical or
documentary.
Inspectors should follow the appropriate Quality Assurance Project
Plan (QAPP) for the State Lead Agency (SLA)/Tribe/Region.
AUTHORITY
Section 9 (a) of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), as amended, authorizes any officer or employee duly
designated by the Administrator to enter, at a reasonable time, any
establishment or other place where pesticides or devices are held
for distribution or sale for the purpose of inspecting and obtaining
samples of any pesticides or devices packaged, labeled and released
for shipment, and samples of any containers for labeling for such
pesticides or devices.
Section 12(a)(2)(B) of the Act makes it unlawful for any person to
refuse to allow an officer or employee of the EPA to take a sample
of any pesticide pursuant to Section 9 or to inspect records to be
retained pursuant to Section 8. Should consent not be granted, see
Chapter 15 for obtaining a warrant.
OBJECTIVE
An official sample of a pesticide formulation or device is necessary
for use as evidence in most of the enforcement actions taken as a
result of a producer or marketplace inspection. A sample must be
suitable to support the government's charge that there has been a
Appendix A • FIFRA Pesticide Sampling Procedures • A-1
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FIFRA Inspection Manual, February 2002
violation of the law. The sample must also conform to the rules
regarding admissibility of evidence. A properly collected, prepared,
and documented sample includes the following:
> Sufficient portion of a batch of a pesticide for laboratory
analysis (as stated in other chapters of this manual, please
consult the lab that analyzes your samples and make sure
you are shipping enough quantity of sample, and that they
can analyze for that chemical or active ingredient, which will
be shipped to that location.)
*• A report of the inspector's observations of the batch, which
may also include photographs and/or copies of records, data,
or correspondence.
* Labeling and/or literature, or copies of these items, that
accompany this product and/or batch, during sale or
distribution.
* Signed statements from people who may potentially serve as
witnesses.
POLICY
It is important to reduce, to a minimum, the amount of time
between the date of sample collection and the date that any
appropriate enforcement action is taken. The inspector plays an
important role in minimizing this interval by promptly forwarding
all samples and records to the laboratory. Pesticide formulation
samples shall not be held for more than five working days before
making arrangements to transport to the laboratory.
SAFETY
It is the responsibility of inspectors to protect themselves and
others during pesticide sampling and sampling activities associated
with an inspection. To minimize risk, appropriate protective
clothing and safety equipment must be used by the inspectors.
Protective gear must be adequate to prevent accidental exposure to
pesticides through eyes, nose, mouth, and skin. The inspector shall
refer to the precautions described on the pesticide label during
formulation sampling and handling.
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TYPES OF SAMPLES
Official samples of pesticide products or devices are those that, if
potentially violative or otherwise problematic, serves as a basis for
legal or regulatory action. In general, an official sample is
categorized in one of five ways: physical, documentary, import,
induced, and use dilution.
Physical Samples
A physical sample (identified as "PHY") is an actual sample of the
pesticide formulation or device. The physical sample may include
the original labeled packaging, copies of or photographs of the
label, and all other labeling associated with the pesticide or device.
Copies of any records showing the distribution or sale of the
physical sample will be collected for documentary purposes. Copies
of shipping records substantiating the distribution or sale of the
pesticide product or device are vital to all enforcement cases.
Documentary Samples
A documentary sample (identified as "DOC") is taken when a
physical sample of a pesticide or device is not collected. Copies of
bin labels, photographs or advertising, and copies of shipping
records, invoices showing shipments of the product and the
responsible parties are normally collected for documentary
purposes. Labels are an important part of documentary sampling
and should be collected if possible.
The following is an example of a statement that can be used when
obtaining documentary samples:
"My name is Jane Doe and I am the production manager for ABC
Corp. in Chicago, IL. As such, I oversee the shipment of all
products, including pesticide products, that leave the warehouse.
To the best of my knowledge, the bin label for the product, Mighty
Roach Killer, that was collected by Inspector Clouseau as sample
number 021201187560101, is a true and accurate representation of
the label that was affixed to the product Mighty Roach Killer that
was shipped on January 5, 2001, as indicated in the shipping record
collected by Inspector Clouseau as sample number
021201187560102."
Import Samples
Import samples (identified as "IMP") are physical or documentary
samples of pesticide formulations or devices that are offered for
importation into the United States from foreign countries.
Documentation for imported shipments should include U.S.
Customs Service entry papers, foreign invoices, shippers' Bill of
Lading and records showing movement from the port of entry are
necessary (see Chapter 14).
Induced Samples
An induced sample should not be considered until all other sources
for direct purchase have been exhausted. Induced samples
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(identified as "IND") of pesticides or devices are usually requested
by mail, telephone, or the internet. Complete documentation is
necessary, including the original advertisement. A webpage printout
may be considered advertising of the pesticide product, but your
FIFRA attorney should be consulted before collecting this
evidence.
Use Dilutions
Use dilution samples are collected during pesticide use inspections.
A formulated pesticide has been blended with a carrier such as
water, and is ready to be applied by an end user.
SAMPLES
The sample must be identified, officially sealed, and documented
immediately following collection. Official pesticide formulation
samples are normally collected only from material that has been
packaged, labeled, and released for shipment. The term "packaged,
labeled, and released for shipment" refers to the point in the
production-marketing process of a pesticide where (1) the product
has been produced and (2) it is the intent of the producer that such
products are introduced into commerce.
At the producers' establishment level, such intent to introduce the
product into the channels of trade may be evident by the following:
* The producer's assertion that the material being sampled is
representative of what is actually sold.
* The product is stored in areas such as loading docks,
warehouses, or other areas where finished goods are held for
shipment in the ordinary course of business.
At the distributor (wholesale and retail) level, the product is
considered to have been "released for shipment" by the producer
establishment and, therefore, is subject to inspection and sampling.
Sample Collection Procedure
> Review all pesticides that are packaged, labeled, and
released for shipment for label/labeling violations.
*• Immediately following the collection of a sample, the sample
shall be identified, officially sealed, and documented in
inspection notes, and inspection forms. Official pesticide
formulation samples are normally collected only from
material that is packaged, labeled, and deemed released for
shipment by the manufacturer. The term "packaged,
labeled, and released for shipment" refers to the point in the
production and marketing of a pesticide where (a) the
product has been produced, and (b) it is the intent of the
producer that such product be introduced into the channels
of trade.
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At the producer establishment level, such intent to introduce
the product into channels of trade may be documented by (1)
the producers assertions that the material being sampled is
representative of what is actually sold in the marketplace, or (2)
the product is stored in a loading doc, warehouse, or other area
where finished goods are held for shipment in the ordinary
course of business.
At the distributor level, in wholesale and retail marketplaces,
the product is considered "released for shipment" by the
producer establishment, and therefore, subject to inspection
and sampling.
> Ask the Ask the management if they would like a duplicate
sample(s). If yes, the inspector will collect and prepare two
identical samples. The inspector will take one and leave one
for the firm.
What to Sample
*• Sample all products found with apparent label/labeling
violations.
*• Obtain samples ONLY from products or devices that are
packaged, labeled, and released for shipment.
*• Obtain samples from all types of pesticides being formulated
during PEL Example - Insecticide, Herbicides, Fungicides,
etc.
*• Sample technical material imported directly from overseas
during PEL Indicate on the Sample Collection Report that
the sample is an IMPORT.
Number of Samples to Collect
*• It may be desirable and up to the discretion of the inspector
and supervisor, to sample all non-violative products during
Producer Establishment Inspection. During a Producer
Establishment Inspection sample all violative products that
are found.
*• Sample about 20% of the technical material imported from
overseas. Document as a marketplace sample.
Amount of Material to Collect
*• Samples shall be taken from original, previously unopened
shipping cases. If more than one code or batch number is
present, the predominant code or batch is to be sampled.
*• If different sized containers are present and the labels are
identical (except for net contents), only one size needs to be
sampled and the number of cases of each size is recorded on
the Sample Report.
Liquid, Dry, and Aerosols (Collecting the Entire Container)
*• Select an unopened case that is packaged, labeled, and
released for shipment.
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Open the container, and remove one container from the case,
remove two if duplicate samples are requested. Note: Collect
two aerosols cans for each sample.
Complete the information on the sample bottle label and
attach it to the side of the container(s).
Place the container(s) in an inverted polyethylene bag,
secure with a knot, fold top of plastic bag over the knot,
twist the bag, and tape below the knot. Place an EPA Official
Sample Seal (EPA Form 7500-2) or equivalent State/Tribal
Sample Seal, if conducted as a State inspection around the
tape which is below the knot.
Restore the case lot to its original location.
If collected at a producing establishment, take photos of the
container label/labeling of the physical sample. Obtain a bin
or specimen label of the product sampled, as back-up to
photos (or in the case where photos can't be taken) to
accompany the sample. Note: Place the following statement
on the bin label "Bin label is the same as the label on the
container sampled." Have the manager initial and date the
statement. Place the assigned sample number and the
inspector's initials in the upper right-hand corner of the
label.
Have the management sign the Sample Collection Report
and leave the top copy with management for their Receipt
for Samples.
SUB-SAMPLING FORMULATION PESTICIDES
Liquid Formulations
*• Review the label for personal safety equipment requirements
and if manufacturers' instructions include shaking before
use. If so, be sure material is thoroughly mixed before
opening the container. Put on required safety equipment.
Note: Do not attempt to agitate containers larger than 5
gallons.
*• Fill out "Pesticide Sample Collection Report" and "Sample
Bottle Label" completely and accurately.
*• Remove cap, flex-spout, or bung. Remove slowly to release
any pressure inside the container. Note: If container opening
is covered by a foil seal, a small hole must be punctured in
the seal with a nail.
* Attach a Y- 7 piece of tygon tubing or straw to an unused
30cc syringe.
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Pull the plunger to the lOcc mark and insert the tubing/straw
and slowly extract 20cc's of the liquid. Note: Any pesticide
whose primary active ingredient is less than 2.0% should
have 3 ounces of the liquid collected. Place in a 4-oz. glass
sample bottle. The extra amount is needed for analytical
purposes.
Extract the liquid slowly, keeping a lOcc air gap between the
liquid and the rubber tip on the plunger. Note: Some liquids
react with the rubber tip causing it to swell, resulting in
difficulty in discharging the extracted liquid.
Carefully discharge the liquid into a dean unused 1-oz glass
sample bottle and attach the "Sample Bottle Label" to the side
of the bottle.
Reseal the container with the cap, new flex spout, or bung. If
a foil seal was punctured, place a small piece of metal tape
over the hole.
Take photographs of the entire label/labeling including the
top and bottom of the container if a bin label is not available
during a PEL
• Identify each photograph with the assigned sample
number, inspector's initials, date/time, and a brief
description of the photograph on an address label.
• Place the photographs in a clear sheet protector and attach
the address label at the bottom of each photograph.
• Digital photographs must include the date and, if possible,
time of the photograph so that this information is
imprinted on each photograph. Be mindful that the
inspector may be challenged in court as to whether the
photographs have been altered in any way.
Place the sample bottle in an inverted polyethylene bag,
secure with a knot, fold top of plastic bag over the knot,
twist the bag, and tape below the knot, place an EPA Official
Sample Seal (EPA Form 7500-2) or equivalent State/Tribal
sample seal if conducted as a State inspection around the
tape which is below the knot.
Restore the case lot to its original location.
If collected during a Federal PEI, obtain a bin or specimen
label of the pesticide sampled to accompany the sample,
make a word-for-word comparison against the label on the
container sampled in order to verify that the labels are
identical. Note: Place the following statement on the bin
label "Bin label is the same as the label on the container
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sampled." Have the management initial and date the
statement. Place the assigned sample number and the
inspector's initials in the upper right-hand corner. For
Federal inspections, federal forms and procedures must be
followed.
*• Have the management sign the Federal Receipt for Samples.
Place all paperwork pertaining to the sample in an EPA
sample folder and arrange in the following order:
• Pesticide Sample Collection Report.
• Photographs or bin label.
• Dealers Statement.
• Shipping documentation.
• Notice of Inspection.
> Deliver the sample(s) and sample folders to an approved
laboratory.
Dry Materials (Dusts and Granular
Formulations)
*• Review the label for personal safety equipment
requirements. Put on required safety equipment.
*• Fill out "Pesticide Sample Collection Report" and "Sample
Bottle Label" completely and accurately.
*• Select two representative bags from the lot to be sampled
and lay them flat. Note: On granular materials the bags
selected should be turned end over end several times to
redistribute any fine materials which have sifted to the
bottom during shipment and storage.
*• Cut a V-shaped slit on the side or flat surface of the bag
where writing is not found. Note: Use only a dean knife for
cutting the slit. NEVER use a pocket knife used for other
purposes.
> Insert a clean unused plastic tube diagonally through the
bag, when obtaining the sample, not just from one location
in the bag.
* Carefully remove and fill a sample bottle/can with the
material and identify the sample with the inspector's initials,
the sample number, date, etc. on the side of the bottle/can.
Note: Any pesticide whose primary active ingredient is less
than 2.0% should have 4-ozs of the material collected. The
laboratory needs the extra amount for analytical purposes.
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Reseal the bag(s) by placing a piece of wide imprinted
inspection tape over the slit with the date sampled and
inspectors' initials and restore the container to its original
location.
Take photographs of the entire label/labeling including the
top and bottom of the container if a bin label is not available
during a PEL
• Identify each photograph with the assigned sample
number, inspector's initials, date/time, and a brief
description of the photograph on an address label.
• Place the photographs in a clear sheet protector and attach
the address label at the bottom of each photograph.
• Digital photographs must include the date and, if possible,
time of the photograph so that this information is
imprinted on each photograph. Be mindful that the
inspector may be challenged in court as to whether the
photographs have been altered in any way.
Place the sample bottle in an inverted polyethylene bag,
secure with a knot, fold top of plastic bag over the knot,
twist the bag, and tape below the knot, place an EPA Official
Sample Seal (EPA Form 7500-2) or equivalent State/Tribal
sample seal if conducted as a State inspection around the
tape which is below the knot.
Restore the case lot to its original location.
If collected during a Federal PEI, obtain a bin or specimen
label of the pesticide sampled to accompany the sample,
make a word-for-word comparison against the label on the
container sampled in order to verify that the labels are
identical. Note: Place the following statement on the bin
label "Bin label is the same as the label on the container
sampled." Have the management initial and date the
statement. Place the assigned sample number and the
inspector's initials in the upper right-hand corner. For
Federal inspections, federal forms and procedures must be
followed.
Have the management sign the Federal Receipt for Samples.
Place all paperwork pertaining to the sample in an EPA
sample folder and arrange in the following order:
• Pesticide Sample Collection Report.
• Photographs or bin label.
• Dealers Statement.
• Shipping documentation .
• Notice of Inspection.
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Deliver the sample(s) and sample folders to an approved
laboratory.
DOCUMENTARY SAMPLES
Select an unopened case that is packaged, labeled, and
released for shipment.
Remove one container from the case.
Take photographs of the entire label/labeling including the
top and bottom of the container.
• After development of the photographs, identify each with
the assigned sample number, inspectors initials, and a brief
description of the photograph on an address label.
• Place the photographs in a clear sheet protector and attach
the address label at the bottom of each photograph. Note:
The photographs must be legible to be valid.
• Digital photographs must include the date and, if possible,
time of the photograph so that this information is
imprinted on each photograph. Be mindful that the
inspector may be challenged in court as to whether the
photographs have been altered in any way.
Restore the case lot to its original location.
If collected during a PEI, obtain a bin or specimen label of
the pesticide sampled to accompany the sample, make a
word-for-word comparison against the label on the container
photographed in order to verify that the labels are identical.
Note: Place the following statement on the bin label "Bin
label is the same as the label on the container photographed."
Have the management initial and date the statement. Place
the assigned sample number and the inspector's initials in
the upper right-hand corner.
Complete a "Pesticide Sample Collection Report" on each
sample collected.
Complete a Dealer's Statement and obtain shipping
documentation on the pesticide such as an invoice, bill of
lading, shipping records, etc.
Have the management sign the Federal Receipt for Sample
form and leave the top copy with the management.
Place all paperwork pertaining to the sample in an EPA
Sample folder and arrange in the following order:
• Pesticide Sample Collection Report.
• Receipt for Samples.
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• Photographs or bin label.
• Dealers Statement
• Shipping documentation.
• Notice of Inspection.
Producer Samples
Since the sample is collected at the location where the pesticide is
produced, only limited paperwork is required:
* Notice of Inspection.
* Receipt for Samples.
*• Pesticide Sample Collection Report.
> Bin label of the label.
* Photographs if required, see sampling instructions.
> Any additional labeling/sales literature, document in a
statement.
* Obtain copies of shipping records, invoices, etc. to document
outgoing or incoming shipments of potentially violative
pesticides/devices.
Marketplace Samples
Since the pesticide is sampled in channels of trade, its movement to
its present location must be documented. Accomplish this by
obtaining a copy of the sales invoice, bill of lading, or freight bill
and document it in a Dealers Statement. Required paperwork is as
follow:
* Notice of Inspection.
* Receipt for Samples.
*• Pesticide Sample Collection Report.
*• Photographs of the entire label and labeling.
* Sales Invoice.
* Dealer's Statement.
> Any additional sales literature accompanying the product,
document in the Dealer's Statement.
Additional Labeling
When collecting samples (Physical or Documentary) ask the
interviewees if there is any additional labeling, including advertising
literature. Make sure that all labeling and literature are collected in
the cases of Producer Establishment Inspections, Marketplace
Inspections, and Export/Import Inspections. This material shall be
identified in the inspector's handwriting with the sample number,
inspector's initials, and exhibit number in the upper right-hand
corner. Examples of an exhibit number would be the inspector's
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initials plus a numeric number, JES-01. The inspector shall initial
and date each of the collected materials. Document the literature
with Statement during a PEI and during a Market Place Inspection.
Payment for Samples
Payment shall be offered for physical samples collected, when the
entire container is collected. Distributors and dealers are entitled to
invoice cost plus a nominal charge (usually 10 to 15 percent) for
freight, handling, and storage. Producers are entitled to their
production cost.
Shipment and Custody of Samples
Following collection, documentation, and initiation of chain-of-
custody, samples shall be stored in a cooler and kept secure prior to
transfer to the laboratory. Pesticide samples must have a "Chain of
Custody Record" form completed by the inspector before
delivering to the laboratory. When transporting sample(s), several
requirements shall be followed:
* Glass containers shall never be packaged directly against one
another.
* The sample label, whether for a prepackaged unit or for sub-
sampled material, shall always be legible through the plastic
bag on physical samples.
*• Sample records, inspection reports, and other
documentation should be shipped to the Laboratory under
separate cover, i.e., do not include these documents directly
with the sample. Samples should be shipped to the
laboratory as-soon-as-possible, the shipment shall include
information to the lab as to the identity or suspect identity of
the sample(s). The shipment shall also indicate that further
documentation regarding the sample will be forwarded to
the lab, ASAP.
Appendix A • FIFRA Pesticide Sampling Procedures • A-12
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APPENDIX B
FIFRA INTERVIEWING
TECHNIQUES
INTRODUCTION
Interviewing can be defined in a variety of ways. The definition can
be as simplistic as the "task of gathering information" or "a face-to-
face discussion between two people, directed toward some specific
purpose." It is also defined as the complex "process of dyadic
communication with a predetermined and serious purpose designed
to interchange behavior through the asking and answering of
questions." Whatever definition you choose, one factor remains
constant: Interviewing is a skill that can be learned, polished, and
improved through practice.
Felix Lopez (1975) compares the professional interviewer to a
professional musician. He says that interviewing is very much like
piano playing — a fair degree of skill can be acquired without the
necessity of formal instruction. But there is a world of difference in
craftsmanship, in technique, and in finesse between the amateur
who plays "by ear" and the accomplished concert pianist. The self-
instructed player mechanically reproduces on the keyboard certain
melodies that have been committed to memory; the artist, creates
an effect that is technically precise, pleasing to the audience, and
expressive to the pianist's inner feeling by skillfully blending
mastery of musical theory, countless hours of practice, and personal
interpretation.
There are certain individuals who are lucky; they are able to play a
musical instrument naturally. Likewise, there are certain individuals
who communicate well quite naturally. But, can they explain what it
is they are doing and why? No. An important skill is developed
when we learn how to analyze a situation, determine what
alternatives exist, and then make a choice as to how to proceed. It
is through knowledge that we can repeat successes and avoid
failures.
Investigative interviewing involves an objective search for the truth.
The investigator must first be aware of his own personal strengths
and weaknesses. Ask yourself the following:
*• What people skills have I developed?
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*• What personal qualities do I possess which will aid me in my
quest for the truth?
*• What is my attitude?
*• Do I use my authority judiciously, or do I approach
interviewees as an authoritarian?
*• Am I able to consciously use my abilities and skills as
needed within the interview to reach my objective?
*• Do I have ten years of experience or one year of experience
repeated ten times?
The people you will be interviewing can be categorized into the
following three broad categories: victims, witnesses, and suspects.
They will exhibit varying degrees of cooperation, reluctance, and
hostility. Information gathered through interviewing is critical to
the successful completion of your investigation. Focus on skill
development in the age-old art of persuasion. Such skills will assist
you in fostering a greater degree of cooperation with lesser degrees
of reluctance and hostility. No one has to talk to you; therefore,
your mission is to persuade or "sell" them to do so. Your ability to
"set the stage" through the use of verbal, nonverbal, symbolic, and
written communication to affect the interviewee's perceptions and
thus to bring about desired changes in ways of thinking, feeling,
and/or acting, is critical to the development of effective
interviewing skills.
The purpose of interviewing in the law enforcement environment is
to gather information. The interviewing process is a dynamic, ever-
changing interaction, with many variables operating with, and
acting upon, one another. To understand and effectively employ
this process, the investigator must first examine the interview as a
unique form of interpersonal communication. It is useful to break
the process into five steps or phases. The synopsis below is
followed by detailed information on each phase.
THE FIVE PHASES OF A LAW ENFORCEMENT INTERVIEW
> Introduction - Identify yourself, your partner, and the
interviewee; state the purpose for the interview. As a general
rule, do not lie.
* Rapport - Create an atmosphere of trust. There is a two-fold
purpose for this; it conditions people to talk to you, and it
provides a chance for you to establish a nonverbal standard.
* Questions - Begin initial interviews with a "Tell me..."
instruction. Then use the six "w's" to obtain additional
information. We usually go from general to specific
questioning.
*• Summary - Summarize what the person has said. This
provides you an opportunity to check for accuracy, and
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provides the person an opportunity to add new information
that comes to mind as you review. In a two-interviewer
situation, the Secondary interviewer is responsible for this.
* Close - Be certain to thank people for talking with you. In
addition, provide them with a way to contact you and
request a way for you to make further contact with them. (A
business card is a handy tool for this.).
Whenever possible two persons should conduct an investigative
interview. One investigator assumes the role of primary interviewer
and takes the major role in the interview. The primary interviewer
makes the introductions, states the purpose, establishes rapport,
and asks the first series of questions. The primary interviewer is
responsible for setting the tone of the interview, and observing the
interviewee via all modes of communication. The primary also
ensures that the secondary interviewer knows exactly what is
required of him/her.
The secondary interviewer initially assumes a passive role in the
interview. The secondary interviewer has the main task of recording
the interview by taking notes; however, the secondary interviewer
also observes the interviewee, asks- additional follow up questions,
and summarizes what has been said when it is his or her turn.
It is advantageous for the primary and secondary interviewers to
avoid interrupting each other. This will allow each to plan his or
her own strategy and employ that strategy throughout the
interview.
The Introduction Phase of the Interview
(Stepl)
Each enforcement interview starts with a three part introduction.
First, the investigator identifies himself and partner and provides
agency credentials. It is recommended that the investigator also
make it a practice to produce credentials as a matter of routine.
Second, the investigator, when necessary, will identify the
interviewee. The point here is to make certain that you know to
whom you are speaking.
Third, the investigator identifies the purpose of the interview.
Almost everyone experiences apprehension when the meaning of a
law enforcement interview is not clear. The investigator needs to
address the issue early in the interview.
It is recommended that the investigator make a clear statement of
purpose during the introduction. The statement of purpose is not
meant to reveal detailed facts of the case but rather, to provide an
overview of what is to come—inquiries pertaining to a specific
investigation. A well stated purpose will provide a reason for the
interviewee to talk with you.
Be truthful in stating your purpose. When determining how to
word the purpose, consider the following:
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> Will the stated purpose be specific enough to encourage the
person to respond to your questions?
> Will the stated purpose be consistent with the questions you
intend to ask?
*• Will your verbal communication be consistent with your
nonverbal communication?
*• Will your credibility be destroyed if you mislead the person
as to purpose? What is the potential effect on the interviewee
when he/she learns the truth? What potential effect could
this have on your case at trial time?
Symbolic communication is especially important during the
Introduction phase of each interview. Symbolic communication is
the message we send through inanimate objects. This mode of
communication is essentially passive and messages emitted in this
way are very easily misinterpreted.
Symbolic communication can have a major impact on first
impressions which are likely to be made within the first 30 seconds
of contact. These first impressions, or gut reactions, often become
a base from which we make judgments and decisions, and may well
become "a self-fulfilling prophecy."
The first few seconds spent in opening the interview are crucial.
What the investigator does during this short time period sets the
stage for the interview. The interviewer wants to project an image
with which the interviewee can identify. The tone may be serious or
light, formal or informal, threatening or non-threatening, relaxed or
tense; but whatever the tone, the criminal investigator must make
sure that it is the one intended and appropriate.
The main function of the first few seconds is to motivate the
interviewee to participate freely and accurately. A poor opening
may lead to a superficial interview with inaccurate information or,
no information at all.
What you communicate symbolically, deserves your conscious
attention. Your personal appearance, grooming, and style of dress
play important roles in "setting the stage" for the interview. We say
a great deal to each other about who we are and how we experience
each other and the rest of the world through symbolic means. To
set the stage, we must dress for the part. Some of the symbolic
communicators that the criminal investigator wants to be aware of
and use to advantage include:
*• Clothing - Our choice of clothes can tell a great deal about
who we are, what our values are, what our status is, and
how conservative or liberal we are. We associate differences
in occupational status with different uniforms; the banker
wears a suit, the mechanic wears overalls, and so on.
> Hair - Hairstyles and facial hair say a great deal about who
we are; however, these signals may be read differently by
different people. We often stereotype people according to
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haircut. Bearded men may be presumed to be more liberal
than unbearded men; men with long hair may be presumed
to have different political, economic, and social philosophies
than men who have short hair.
> Jewelry - Our jewelry sends passive messages to other
people. For example, in our culture, we believe and expect a
person wearing a band on his or her left ring finger to be
married and we expect a person who regularly wears lots of
gold to have money. We make determinations about people
who wear beads, a flag in the lapel, a peace symbol around
the neck, or an earring in one ear, etc.
* Cosmetics or makeup - People tend to attach meaning to
different degrees of cosmetics and makeup. For women, the
prostitute may be expected to wear heavier makeup than
other women. Both men and women who use an abundance
of cosmetics such as after-shave or cologne send symbolic
messages; others draw conclusions—self-centered, arrogant,
trying to appear younger, etc.
* Choice of automobiles - The business executive who drives
a sports car is sending out a different set of messages to the
world than is his colleague who drives a pick-up truck. The
"Image" created by driving a BMW differs from that created
by driving a Ford.
* Choice and location of our houses - Social status is directly
related to the type of dwelling one lives in and its location.
People draw conclusions based on what your home
symbolizes to them.
* Geography of our living spaces - If you sit behind your desk
in your office interviewing someone who is on the other side
of the desk, you are giving out a fundamentally different set
of messages than if the two of you sit face to face with no
intervening furniture.
We give out a continuous stream of signals about ourselves by way
of symbolic communicators. These symbols are essentially passive
but are a real part of our communication. We, as investigators,
must realize that the interview is a reciprocal interaction and that,
psychologically, the degree to which we (and they) are willing to
accept what another person has to say depends on three things:
> How trustworthy the person is seen to be.
> How qualified the person is seen to be.
*• What type of person the individual is seen to be.
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Inappropriate attire, grooming and other symbolic communicators
greatly reduce the ability to command authority and maintain
credibility. Symbolic communication can have a major impact on
first impressions. Remember, while you are "sizing up" the
interviewee, he or she is also "sizing you up." Much of this
unconscious decision-making is made by analyzing the inanimate
objects that one wears or owns.
The Rapport Phase of the Interview (Step 2)
Rapport might be defined as a relationship marked by harmony.
Although it is listed as "Phase #2", rapport is a process that begins
with the initial contact and continues throughout the interview. It
must be genuine and not phony. It can be as simple as a handshake
or a smile; it can be simply that you present yourself well and come
across as decent, fair, and easy to talk with. The success of your
interview may depend on your ability to persuade the interviewee to
talk. Because many people resist giving information to a stranger,
the investigator must attempt to establish a sincere and trusting
environment - one that encourages interaction. This is known as
establishing rapport. Remember, rapport begins the moment
contact is made. To help you establish rapport:
*• Identify yourself immediately, and present your credentials
to provide assurance.
*• Begin the inter-view by commenting on a topic of apparent
interest to the interviewee. (Most people love to talk about
themselves; let them.)
* Establish confidence and trust by having a friendly
discussion when appropriate.
* Keep conversation informal and easy.
*• Display pleasant emotional responses and avoid unpleasant
expressions.
*• Encourage the interviewee, but never hurry or pressure him.
*• Appear interested and sympathetic to the interviewee's
problems. Really listen.
*• Save direct questions that may insinuate involvement or
guilt until later in the interview, or until a second interview.
*• Don't begin the tough part of the interview until the
interviewee appears friendly and cooperative.
*• Try to re-establish rapport at any time during the interview
when the subject appears to have become reserved or hostile.
*• Keep the twofold purpose for rapport in mind:
• It conditions the interviewee to talk, which can set a
pattern which may commit the interviewee to continued
cooperation.
• It is helpful in reducing any general nervous tension
generated by the investigator's "knock on the door."
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Nonverbal communication is especially important during rapport-
building efforts and, in fact, throughout the interview. Assessing
nonverbal behavior patterns assists the investigator in determining
a "baseline" behavior, or "standard", for comparison, and aids in
detecting deception. Investigators need to be aware of the four
forms of nonverbal communication which follow.
Body Movement (Kinesics)
Kinesics is the study of body movement, posture, and gestures.
Body movement either agrees with or contradicts verbal
communication. In order for us to believe we are hearing the truth,
body movement and verbal communication must be congruent.
When nonverbal communication contradicts the spoken word, we
are inclined to disbelieve what is said. Through careful observation,
investigators can detect consistencies or inconsistencies in
testimony. Sigmund Freud stated, "He that has eyes to see and ears
to hear may convince himself that no mortal can keep a secret. If
his lips are silent, he chatters with his fingertips; betrayal oozes out
of him at every pore" (Knapp, p. 229). In other words, we send
signals (give ourselves away), unknowingly. What the investigator
must do is learn to recognize such clues to truth and deception.
The investigator wants to use body movement to his or her
advantage and assess the meaning accurately.
Posture is a good indicator of emotional states. A person who
stands or sits very straight and stiff typically has a good deal of
muscle tension, which is a cue for a high amount of emotion.
Posture also is a good reflection of status. When the status of two
individuals is unequal, the superior's posture tends to be relaxed,
while the subordinate's posture tends to be more rigid. Changes in
body posture, for example the crossing and uncrossing of legs and
the constant shifting of body weight, suggest anxiety. The
interviewer must then determine the cause of that anxiety.
Categories of nonverbal behaviors vary from group to group and
from culture to culture. A vast amount of research has been done
on body movement, gestures, postures, etc. Ekman (1986)
classified certain nonverbal behaviors into five categories:
> Emblems are gestures that can take the place of verbal
communication. For example, waving the hand or giving
someone "the finger."
> Illustrators are gestures that aid the verbal communication.
They are nonverbal acts that assist us in encoding and
decoding information. For example, talking with our hands
and pointing when giving directions.
> Regulators are body movements we use when interacting
with others that indicate a change of subject, end of a
thought, agreement, end or start, of an interaction, etc. For
example, shifts in posture, nodding yes, or shaking the head
no.
> Affect displays are nonverbal behaviors that reveal the
intensity of our emotion. For instance, posture can indicate
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one's emotional state, but an accurate assessment of what it
all means must be made in conjunction with what the rest of
the body is "saying."
* Adaptors are unconscious nonverbal behaviors we typically
exhibit in times of stress or when experiencing a high
emotional state. For example, twisting the hair or increased
touching of the body.
Eye Movement (Oculesics\Pupillometrics)
For centuries women used the herb Belladonna to dilate their
pupils in order to appear more attractive. However, without the use
of some type of foreign substance, pupil dilation and constriction
are beyond conscious manipulation. Because of this fact, the eyes
are said to reveal one's true inner emotions; therefore, a marked
change in pupil size could indicate a sensitive area for the
interviewee. It could also indicate deception.
Some researchers claim that excessive blinking correlates with high
anxiety levels and that stressors, whether they are physical,
emotional, or mental, have an effect on the size of the pupil. By
taking notice of the changes in this particular unconscious,
nonverbal behavior criminal investigators not only improve their
interviewing skills, but may add vital information to the study of
pupillometry. Even if an investigator does not know what
specifically brought about the change in the interviewee's pupil size,
intensifying the questions at that point may reveal the answer.
A considerable amount of research has also been done on the
relationship between the extent to which individuals open their eyes
and their emotional states. The San-pa-ku phenomenon (Japanese
culture), literally translated as, "three whites", is a condition in
which the whites of the eyes show below the pupils (as well as on
each side of the pupils) when looking straight ahead. It has been
theorized that this condition can be found in those individuals
experiencing high emotional levels or high stress. When noticed,
the investigator must add it to other nonverbal indicators in order
to make an accurate assessment of why it is happening.
Gaze is also important in evaluating for truth and consistency.
Gazing refers to one's "looking" behavior; this behavior may or
may not be directed at another individual. Mutual gazing refers to
two individuals looking directly at each other, typically in facial
region. Gaze aversion is a normal response to high anxiety levels
and refers to the avoidance of eye contact in an uncomfortable
situation.
Research tends to support the theory that we look more at those
we view in a positive light and from whom we desire approval.
"Researchers have also found that a person will like you more if
your gazes are longer and less frequent rather than shorter and
more frequent. Constant shifting or darting of the eyes
communicates discomfort or even dishonesty"
(Hamilton, 1987, P. 1 19).
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An uninterrupted gaze is a stare. Stares may be interpreted as
threatening or may be considered a power display. Stares often lead
to a gaze aversion by another. Stares may indicate assertiveness,
dominance, waiting for a response, or a request for help. Whether
the interviewee is staring, gazing, or simply making eye contact is
up to the criminal investigator to determine. When making this
determination, consider the amount and direction of the eye
movement and whether it is different from the established pattern
(baseline).
Space and Distance (Proxemics)
Animals are territorial. Predators will mark off a section of woods
for their hunting; grazing animals will allow you to get only so
close - another step and they flee. This concept has been applied to
man and research has lead to the determination that there are
average distances at which humans are comfortable. The study of
these distances is called proxemics.
The distances at which we are comfortable with other people vary
from individual to individual, and culture to culture. For the
mainstream American culture, the information below shows the
"space bubble" a person surrounds himself with.
> Intimate Zone (O" to 18") -This is the distance used with
lovers, close friends, and children. We are uncomfortable
and tend to back away if strangers penetrate too dose
without our permission.
> Personal Zone (1-1/2' to 4') -This is the distance normally
used to conduct conversations and deal with people on a
one to one basis. It is the area defined by personal physical
control or "an arm's length."
> Social (4' to 8') -This is the distance used to conduct
impersonal business and to deal with strangers.
* Public (8' and beyond) -This is the distance used for more
formal social or business affairs. The desk officer dealing
with police business falls into this area.
In different cultures the zones may shrink or expand. For example,
in Arab countries, the personal zone moves in to about 12 inches.
In most cultures, males prefer a slightly larger space bubble than do
females. If the zone we prefer to keep a person in is violated, we
begin to feel uncomfortable. In some cases open hostility results.
Interviews are usually started in the personal or social zone. The
distance can then be varied depending on the situation and goal.
The key concept in using distance in an interview is to give the
interviewer a psychological advantage by making the hostile subject
anxious or making the friendly witness comfortable. Sometimes,
investigators may find that using the personal zone with victims is
an effective tool in demonstrating caring and concern; learn to vary
the distance (creating or lessening anxiety) as necessary to achieve
your goal.
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The feeling of intimacy and the resultant anxiety is not determined
by physical distance alone. Argyle and Dean, (1965) define intimacy
as a function of eye contact, physical proximity, intimacy of topic,
amount of smiling (i.e., threatening or non-threatening nonverbal
communication), and physical environment. A knowledge of space
expectations helps us to understand why seemingly innocent people
sometimes react defensively to the presence of law enforcement
personnel. The reaction may be a backing away to re-adjust
distance, a demand to get out of his face, or an attack. Intrusion
into one's personal space becomes a safety concern because it is
often perceived as both unwelcome and threatening.
Touch (Haptics)
Styles of touch vary according to culture and personal preference.
The importance of touch as a communicative tool is well-illustrated
below:
In a French hospital, a doctor was very concerned about two
things: insufficient staff and high infant mortality rate. He decided
to examine both concerns from a number of angles. He discovered
that due to the shortage of staff, infants were getting minimal
treatment—they were fed and diapered—nothing more. To relieve
the over-worked staff, an appeal went out to the community for
volunteers to work at the hospital. He received volunteers, many of
which spent a great deal of time with the babies: bathing, feeding,
rocking, and, in general, mothering them. The amazing result of
solving his staffing problem produced a 50% decline in the infant
mortality rate. Dr. Talbot of Boston visited the "Children's Clinic"
in Dusseldorf, Germany, and brought back the concept of "tender
loving care." However, it was not until after World War II that the
importance of touching was widely acknowledged in both the
medical and psychiatric fields.
In our country, touch most often begins with the person of highest
status going either across (peer to peer) or down (to lower status).
Exceptions do exist. As a law enforcement investigator (public
servant), touch is acceptable when there is permission, and when
there is obvious good reason. Any violation of these conditions
may cause anxiety. When anxiety levels increase, your safety
decreases. Touch is the most dangerous nonverbal communication
for investigators to misuse; you cannot violate touch without also
violating personal space.
It is essential that the criminal investigator take into consideration
the effect that his or her touching may have on the person he or
she is dealing with. Consider the task at hand. Do you need to
control physically (arrest, detain, change positions)? Do you need to
express compassion and caring? Is there a reason for touching? If
so, how do you touch? Is your manner of touch appropriate to the
situation? Remember, if misused, touch may result in an escalation
of emotions which may increase the potential for danger. If used
properly, touch may be instrumental in defusing a volatile situation,
in calming a distraught victim, in restoring peace, or in gaining the
cooperation of a reluctant witness.
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Evaluating Nonverbal Behaviors
> Context - Consider the big picture including:
• Physical environment
• Intensity of the setting
• Maturity and intelligence level of subject
*• Change - Recognize any change from the person's normal
behavior. Notice the consistency of the change. (It is
necessary to first establish a baseline, or standard, in order
to observe changes.)
*• Clusters of behavior - Assess the overall behavior; do not
rely upon any single observation.
*• Culture - Keep in mind that "normal" may change with
different cultures. Changes in behavior occurring during or
right after a question have been found to be most reliable as
indicators of truth or deception. Such changes are responses
to stress; what the interviewer must do is evaluate the reason
behind the stress. Reactions may indicate deception;
however, they may indicate something else such as fear,
anxiety or illness. The investigator will make an assessment
considering the "big picture."
The Questioning Phase of the Interview
(Step 3)
Questions are basic to most interviews, whether you are conducting
a survey, selecting an employee, evaluating a worker, making a sale,
or conducting an investigation. The ability to use questions
effectively is a key skill for the interviewer. During initial interviews,
questions usually follow the response to a, "Tell me what
happened" instruction. It is important for the investigator to listen
to what is first reported, ask questions, and then develop a
conclusion.
Most often, questions are asked in a conversational manner using
terms familiar to the interviewee. The investigator should give
careful consideration to regional and cultural differences in
vocabulary. Questioning is a four-step process:
> Ask the question.
*• Receive the answer.
> Evaluate the response (for truth and/or consistency).
> Record the response (write it down).
There is a great difference between merely asking questions and
actually making questions work for you effectively. Some
characteristics of good questions are:
* Simple and addressed to one topic.
*• Clear and easily understood.
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*• Contain "soft" words rather than "fighting" words.
Language problems are often encountered during questioning. The
people involved may speak a common language, but the meanings
associated with some words may be quite different. Words are
learned in a particular environment under particular circumstances
and therefore become imperfect vehicles for communication. Yet,
we depend on them to convey intended messages. Meanings are
inside people; we must work to understand where each person is
coming from. Consider the following:
*• Choice of words. Use words familiar to the interviewee.
Many words have multiple meanings which can cause
communication breakdowns between persons of different
ages, professions, geographic backgrounds, economic
statuses, experiences, or educational levels. Keep up-to-date
on changing usage of common words.
*• Vary your voice. Paralinguistics (pitch, volume, rate and
quality of speech) involves how something is said. Pitch is
the highness or lowness of the vocal tones. Volume is the
loudness or softness of the voice. Rate is the speed of the
speech. Quality is the sound of the voice. These
characteristics combine to form the paralinguistic messages
that accompany verbal messages and either complement,
supplement, or contradict the words used. People talk loudly
when they wish to be heard, when they are angry, and when
they are jovial. People also raise and lower their pitch to
accompany changes in volume. In addition, they may also
raise the pitch when they are nervous and lower the pitch
when they are trying to be forceful. Some people talk rapidly
when they are happy, frightened, or nervous and talk slowly
when they are uncertain or trying to emphasize a point. Use
paralinguistics to enhance your clarity of expression.
* Use the pause to your advantage. Unfortunately, in our
society, the listener is deemed to be the first person who
takes a breath. We are constantly fighting each other to see
who can be the first to fill the silence with words and other
noise. Silence generates anxiety. The effective interviewer
will wait to see what the silence will bring. If you wait long
enough, the interviewee is very likely to say more!
Types of Questions to Avoid
Leading This type of question is phrased in such a way that it
suggests the desired answer. The question can generally be
answered with a "yes" or "no" and tends to contaminate the
information obtained. For instance: "You said you saw a car; was it
a red car?" Or, "Did you see the red car?" There are exceptions.
Leading question may be of benefit to:
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*• Enhance recall and possibly obtain more information when
the person can't remember specifics such as color, height,
distance, etc. The investigator can phrase the question in a
way that is leading but makes a comparison and offers a
choice. For example, "Was it a dark car or a light car?"
*• Test whether an interviewee's prior statement is true or false.
For example, "You said you saw him on Monday, or was it
Tuesday?"
Negatively phrased The negatively phrased question not only
suggests that the response is to be "no", but also implies that," no"
is the right answer. For example, "You don't know his name, do
you"" Or, "You didn't see him, did you?" Or, "You don't
remember what she looks like, do you?" Or, "You didn't get the
license number, did you?"
The negatively phrased question may indicate to victims or
witnesses that they don't know the answer and more importantly,
they don't have to try very hard to remember the correct
information. For the suspect, a negatively phrased question
suggests that "no" is the expected answer and thereby may provide
an out."
Compound Questions contain two or more questions asked in
rapid succession before the interviewee can respond to the first
one. Also included in this category is the rephrasing of the original
question before a response is obtained to the first version. Many
compound questions contain the word "or." For instance, "Did you
go alone, or did someone else go with you?"
Compound questions confuse the interviewee and often cause
information to be missed or overlooked. In many instances, when
faced with multiple questions, the interviewee will answer only the
last or, the least threatening, question. The answers to the other
questions are most often lost because the investigator does not
remember to ask them again.
For the suspect, compound questions offer an "out." The suspect
may weigh the implications of the answers to each question and
answer only the questions that are least incriminating and cause the
least amount of stress. The suspect will use compound questions as
an opportunity to conceal information. Further, he or she will rely
on the fact that most interviewers will not ask those "lost"
questions again.
Complex questions are complicated, not easily understood, and
cover more than one topic. Complex questions tend to confuse and
lead to an, "I don't know", or a false answer. For example: "Based
on your prior knowledge of the circumstances leading up to the
incident and the reactions of others indicated by their testimony,
what would have been the suspect's actions throughout this
period?"
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Types of Questions to Use
For initial interviews, questions are sequenced from general to
specific.
Open-ended questions (narrative response questions) ask the
"Who, What, When, Where, Why, and How," or a "Tell me"
instruction. They encourage the person to talk, and allow the
interviewer to obtain the "big picture" of what the person may
know. The interviewer should refrain from interrupting during a
narrative response.
Open-ended (narrative response) questions tend to:
*• Condition the interviewee to talk with us.
*• Commit the interviewee to a story.
> Allow interviewers to evaluate their questioning strategy.
* Generate more complete responses.
*• Aid in determining the education level of the interviewee.
*• Result in responses that shed light on the subject's
personality.
*• Allow for the interviewee's opinions.
> Allow us the opportunity to analyze what has or has not
been said.
> Allow the interviewee to feel in control of the interview.
> Allow for a logical progression of the interview and
continuity of specific questions.
> Take more time.
*• Allow for self-serving statements.
Closed-ended questions (specific or direct) call for a precise answer.
They are direct and tend to be closed-ended. The requested answer
is limited to a definite item of information. The specific question
can be used to extract more detailed information or to clarify after
a narrative response question is answered.
Specific questions often solicit a "yes" or "no" answer. While this
restricts the amount of information a person may be inclined to
give, specific questions do have a place—they are wonderful direct
questions. For instance, "Did you do it?" is an excellent question to
be asked of suspects. Direct questions are seldom used when
seeking new information, but are desirable during cross-
examination or when verifying information.
Closed-ended questions:
> Are important to the speed and efficiency of the
investigation.
> Are directed to exact detail.
* Often save time.
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*• Elicit shorter answers.
*• May inhibit rapport.
* May put more strain on the interviewer.
Backward reaching questions
Backward reaching questions start with the known information and
work toward areas of undisclosed information.
The interviewer mentally reaches backward and frames the next
question as a logical continuation of the facts previously related.
For example, "You said earlier that you went to the convenience
store; how did you get there?"
Empathy or sympathy questions
Another means of asking questions that may assist the investigator
in soliciting information by building rapport is to express empathy
or sympathy and then follow with a question. For example, I can
understand your anger; how many times did you hit him?"
Opinion questions
Although the investigator's main concern is the collection of facts,
a wealth of information is often revealed when opinion questions
are asked.
In many instances the victim or witness will have much information
about how a crime may have been committed or who would be a
suspect. Often, when a suspect is asked how a crime could be
committed, the responses exactly how he did it.
Three Questioning Techniques
First, the free narrative response is an orderly, continuous account
of an event or incident given with or without prompting. The free
narrative follows the effective use of open-ended questions
discussed earlier in this text. Usually it can be initiated by
instructing the person to tell, what happened. The investigator must
be sure to specifically designate the occurrence to be discussed.
Most people will edit the information and give only what they want
to relate or feel is important. Investigators must encourage people
to tell the whole story by facilitating recall and waiting through
pauses. Sometimes, the person digresses - the interviewer must not
be too hasty in stopping him from wandering. The interviewee will
sometimes give valuable clues while talking about things that are
only partially related to the matter under investigation. The
interviewer should be careful not to erroneously interpret
deviations from the anticipated narrative as wandering. We may
wish to control the interview, but that doesn't mean dominate it!
A second questioning technique is direct examination. This is
systematic questioning designed to bring out a connected account
of an event or incident. The direct examination uses the why and
how questions. Its purpose is to elicit new information or to fill in
details omitted during the free narrative. To effectively accomplish
the direct examination the investigator:
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*• Begins by asking questions that are not likely to cause the
person to become hostile.
*• Asks the questions in a manner that will develop the facts in
the order of their occurrence (or in some other systematic
order).
> Asks only one question at a time, and frames each question
so that only one answer is required.
> Asks straight forward and frank questions without using
bluffs, tricks, or deceit.
* Gives the interviewee ample time to answer and does not
rush.
* Tries to help the interviewee remember, but does not suggest
answers. The interviewer is also careful not to imply any
particular answer by facial expressions, gestures, method of
asking questions, or types of questions asked.
*• Repeats or rephrases questions again and again if necessary
to get the desired facts.
> Ensures that answers are understood. If they are not
perfectly dear, he has the interviewee explain them at once.
*• Gives the interviewee the opportunity to clarify answers.
* Separates facts from inferences.
> Has the interviewee give comparisons or estimates of time,
distance, types of automobiles, descriptions of persons, etc.,
to determine accuracy of judgment.
* Gets all of the facts. Almost all interviewees can tell you
more information than they initially recall or admit
knowing.
> Asks questions about every item discussed.
* Asks the interviewee to summarize the information and then
follows up by a resummarization asking the person to verify
the accuracy of the information.
Cross examination is an exploratory questioning technique
conducted for the purpose of testing the reliability of information,
breaking down previous assertions. It is very useful for the purpose
of testing previous testimony for correctness, resolving conflicting
information, determining completeness, filling in evaded details,
evaluating the judgment of witnesses, and undermining the
confidence of those who lie. Insofar as is practical, the investigator
should evaluate and check previous testimony against known, or
readily available, information. This will give clues to portions of
testimony that should be further explored during cross-
examination, such as:
*• Attempts to evade answers.
* Vague answers.
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*• Conflicts of information.
*• Inconsistent answers to the same or similar questions.
* Apparent falsehoods.
* Suspicious actions or appearance of the subject.
Generally, the examining officer should be friendly, but reserved
and unemotional. Effective cross-examination can be conducted
without abuse or coercion. Have the interviewee repeat testimony
about a particular event. Attempt to keep expanding on details at
random without following a definite order or sequence. This is
usually best accomplished by asking about the event in a different
manner from time to time. Ask what happened, why it happened,
when it happened, who was there, why they were there, how the
subject happened to be there, and what preceded or followed the
event.
The investigator should occasionally inject a different context or
relationship of details.
For example, initial question: "When did you first meet the
defendant?" First subsequent query: "Tell me what led up to your
first meeting with the defendant." Second subsequent query: "Did
the defendant give you any indication of his plans prior to the
previously mentioned meeting?" Subsequent query: "How long
after you learned of the defendant's plan did the indicated meeting
take place?" Be alert for inconsistencies in replies; when people are
recalling facts, they will usually be consistent. Liars, on the other
hand, generally find more and more ties are necessary as additional
details are required. They either forget what they have previously
asserted or fabricate details that are not consistent with previous
statements. If you believe you have been lied to, rephrase the
question and ask again.
It is permissible to use suggestive questions during cross-
examinations. "You saw the defendant strike his supervisor, did
you not?" "You had no trouble seeing Richard Roe in the bright
moonlight?" "Would you estimate the distance to the still to be
about one mile?" "Wouldn't you say that only an expert could make
a counterfeit bill this good?" If the interviewee is fabricating
information or lying about an occurrence, he will frequently concur
with suggested answers that fill in details of his story. If many of
the questions are designed to suggest false answers, the interviewee
may make false assertions that can be shown to be erroneous. This
procedure may be valuable in testing the validity of testimony from
witnesses.
Ask about known information as if it were unknown, or ask about
unknown information as if it were known. Use a casual tone and
demeanor. Show no sign of surprise or emotion when false
answers are given. Use good judgment in developing questions that
have a strong probability of being answered affirmatively and
truthfully.
Specifically explore vague or evaded responses to your questions.
Frequently such areas are purposely slighted because they are
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particularly embarrassing to the subject. Always be suspicious that
these slighted details are of direct concern to the person. Often
they involve some previously undisclosed, but pertinent,
information
Point out conflicts. It usually best to ask deception questions
before confronting the subject with evidence of conflicts or proof
of falsehoods. Ask the interviewee to explain inconsistencies or
conflicts in his statements. Tell him his statements have been
proved false by previously established facts, physical evidence,
contradictory circumstances, etc. Ask for an explanation. Any
explanation or revised information should be subject to the same
direct and cross-examination scrutiny as was afforded the original
story. Notice physical signs of lying, such as nervousness, guilty
appearance, dry mouth, and sweating hands.
Summarize the known facts and compare them with the
interviewee's statements. Ask the interviewee to explain each item
of damaging evidence; then point out his illogical answers.
Active Listening During the Questioning Phase
Listening is hard work, and most people don't give it their best
effort. It has even been said that the most common mistake in
communication is the failure to listen. This shortcoming is
especially discouraging in law enforcement because listening is a
critically important element of interviewing. To be an active
listener:
*• Remain neutral.
> Ask questions as needed for clarity.
* Clear your mind of other matters.
*• Concentrate on the response.
*• Paraphrase the response and repeat back to the interviewee
for clarity.
There are many reasons for poor listening. Among them: poor
hearing, personal concerns, noise, rapid thought, and the fact that
the sheer amount of speech that we encounter each day makes it
impossible to listen carefully to everything we hear. But there are
several steps we can take to enhance our listening skills while
engaged in an interview:
> Stop talking. "We have been given two ears and but a single
mouth, in order that we may hear more and talk less." It is
difficult to talk and listen at the same time. Talking includes
the silent debating, rehearsing, and retorting that often goes
on in our minds. The first step to better listening, then, is to
keep quiet when another person speaks.
> Put the speaker at ease. Help the speaker feel free to talk
with you by working to create a supportive climate. Besides
telling the speaker that you care about what is being said,
look and act interested. Non-verbal cues associated with
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caring appear to be more important than a listener's verbal
response. Head nods, eye contact, a forward attentive lean,
and a warm tone of voice are expressions of interest that
provide positive feedback.
* React appropriately. In order to help the speaker realize that
you might be having problems understanding, offer positive
and negative feedback. These behaviors include both verbal
and nonverbal communication such as facial expressions,
nodding, and shaking your head.
* Concentrate. Focus your attention on the words, ideas, and
feelings of the speaker. Put the speaker's ideas into your own
words, relate them to your experience, and think about any
questions you may have.
> Get rid of distractions. Avoid fidgeting with your pen,
playing with a paper dip, or doodling. Whenever possible,
pick a listening environment that minimizes distractions
such as passersby, telephone calls, and loud noises.
* Don't give up too soon. Avoid interrupting until the other
person expresses a complete thought. Statements that at first
seem unclear often make sense if you let the speaker talk for
awhile. Many interviewees will purposely pause, hoping the
criminal investigator will pick up the conversation and let
him off the hook.
> Avoid making assumptions. If you disagree with what you
hear, do not assume the speaker is uninformed, lying, or
otherwise behaving dishonorably. Listen for facts! Get tough
with facts, not opinions!
* Don't argue mentally. Give the speaker a fair chance. If you
argue mentally, you lose the opportunity to listen to what
the speaker has to say.
> Listen for main points and supporting evidence. Effective
interviewing requires that we listen for main points and
support for the speaker's views. To dwell on a side issue or
minor inconsistency while forgetting the main idea is non-
productive.
Share the responsibility for the communication. Communication is
a transaction; we are simultaneously senders and receivers. Use
active listening. Instead of letting your mind wander away from
what is being said in order to plan what you are going to say when
you have a chance, take an active part by attentively listening and
showing interest. Active listening involves questioning and
feedback!
The Summary Phase of the Interview (Step 4)
After asking the questions needed to complete a successful
interview the investigator must summarize to ensure that his notes
are complete and accurate. During this phase, the interviewee will
often clarify, or add to, previously given information.
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The summary is an important part of the interview, especially in the
one-agent-interview, as it allows the interviewer to be sure he/she
has all the information. In a two-agent interview, the secondary
interviewer summarizes from notes just taken and may ask any
questions not asked by the primary interviewer. Steps to a
successful summary:
*• Mentally rearrange the information obtained in logical order.
> Summarize the information by stating important details in
proper sequence.
* Stop periodically and ask the witness to verify the
correctness of your interpretation (paraphrasing).
* Correct any discrepancies before you proceed.
The Closure Phase of the Interview (Step 5)
The final phase of the interview is the close. The close is the
continuation of rapport and courtesy to ensure that the door is left
open for future contact. The interviewer needs to be sure to thank
the interviewee for cooperation, or express empathy for lack of
cooperation. Reassure the interviewee about any concerns, such as,
that the information provided will be de information used for
official purposes only. Give the interviewee the opportunity to
provide information concerning matters not specifically covered
during the interview and make sure the interviewee knows how to
contact you when he or she remembers or obtains additional
information. Get any additional identifying data you may need
(phone numbers, addresses (both home and office), etc.). Ask the
interviewee how, when and where to contact him again if necessary.
WRITTEN COMMUNICATION (NOTE TAKING)
Because interviewers are bombarded with lots of information, both
verbal and nonverbal, some way of preserving the information is
needed. The most common way is to take notes during the
interview. This practice helps the interviewer document
information gathered. Frequently, a review of your notes at the end
of the interview will call to mind things that had been forgotten.
For the purposes of this lesson, law enforcement interviewing will
focus on notetaking only. (There are other important forms of
written communication for the investigator such as written
statements that will not be covered here.)
As an interviewer, you may find that taking copious notes
sometimes inhibits the flow of communication, and you may need
to change your style. Interviewees are often curious about what
you are writing and may even ask what and why you are writing. An
appropriate response may be: "I am taking notes so that I will
accurately record what you are reporting. I will go over them with
you when we are finished." A few guidelines can reduce problems
in taking notes:
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*• Preserve effective communication with the interviewee by
being as inconspicuous as possible. Maintain as much eye
contact as possible while taking notes. Use abbreviations or a
form of shorthand to speed up notetaking.
> Avoid communicating to the interviewee what you think is
important by taking notes frantically during the answer to
one question and sitting patiently through the answer to
another question. Develop a style of notetaking that allows
you to be less conspicuous.
> Bring out your notebook in a natural way early in the
interview. This will allow the interviewee the opportunity to
get accustomed to the idea of notes being taken.
* If you have written out a list of questions, keep them
separate from your notebook and make a list of "key words"
to remind you of the questions. Otherwise, you will be
drawing a great deal of attention to yourself by flipping
pages in your notebook. Also, do not number your questions
or check them off as you go. A quick-eyed interviewee is
likely to glance at your list and gauge the length of the
interview and start editing his answers. It is helpful to leave
margins for additional notes and comments.
* If you are conducting a one-interviewer interview, do not
take notes the first time through. Take notes the second time
through the interview, when you are seeking specific details.
If note taking generates reluctance to talk which you cannot
overcome, remove the notebook from eyesight and wait until
immediately after the interview to record the information received.
Do not ask permission to take notes, but do stop taking them if it
interferes with the flow of information.
PLANNING AND PREPARING FOR THE INTERVIEW
Generally, the investigator must attempt to locate and interview
everyone thought to have information relevant to the case. When
there are multiple witnesses, separate them to avoid information
contamination, and do your interviews in a location where
conversations cannot be overheard. When there are no apparent
witnesses, hard field work may produce information. The
investigator may start by interviewing all persons who live in the
area, the types of merchants who might furnish supplies for the
activity, transportation companies who may have provided
transportation to or from the area. To best conduct the interview,
several planning steps must be considered:
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*• Determine the goal (objective) of the interview. It is
impossible to complete any task efficiently unless you know
what you are trying to accomplish. Sometimes the goal of an
interview seems obvious. What is not always dear is how to
reach that goal. In any interview, the investigator should
make the goal as clear as possible by asking himself/herself:
• What do I know?
• What do I need to know?
• Is the information I seek essential, important or, nice to
know?
A good strategy to assist the investigator in determining the main
objective is to mentally ask, "If I had one, and only one question to
ask, what would that question be?" Often, the answer will provide
direction.
*• Obtain background information. Prior to an interview,
obtain as much information as possible on the details of the
case and the background.
• Read all available investigative reports and talk with other
investigators who may have worked the case.
• Examine any statements that have been obtained.
• If practical, visit the scene.
• Evaluate all related physical evidence recovered to date.
• Check telephone directories, city directories, and similar
sources of information about addresses, occupations,
families, etc.
*• Prepare an outline. The outline should cover every item you
feel you need to explore. The outline acts as a reminder. As
a rule, items outlined will be key words rather than the
actual questions themselves. Many investigators, when using
specific written questions, will fall prey to a natural tendency
to focus on the questions rather than the answers. Active
listening helps us to determine appropriate follow-up
questions. The outline should contain:
• Name and identifying data of the interviewee.
• Date, time, and place of the interview.
• Names of all people present.
• Objectives (pertinent issues) to be covered.
* Determine time, place, and sequencing for the interview.
Interviews should be initiated when there is sufficient time
to permit an extended period of questioning without
undesirable interruptions.
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> Determine the physical environment. The physical
environment (comfort, noise, privacy, distance between the
interviewee and interviewer, seating arrangement, etc.) will
affect interviews. The investigator can enhance the
interviewee's concentration and motivation with a well-
lighted, pleasantly painted, moderate-sized room that has a
comfortable temperature and proper ventilation. Noise,
movements, and interruptions, especially telephone calls,
disrupt concentration, thought patterns, and the mood of the
interview. People have difficulty listening and thinking
when they can see cars on the street outside a window,
persons moving about in an outer office, or other
investigators coming and going. The investigator must
provide for privacy whenever possible.
• Other significant barriers are body barriers (crossed arms
or legs, the cold shoulder, etc.). The investigator will want
to use rapport-building techniques to minimize these.
Sometimes, when rapport is lacking, distraction techniques
such as involving the interviewee in some type of activity
may eliminate or minimize body barriers.
• Usually, initial interviews begin with the interviewer and
the interviewee seated about an arm's distance (3 to 4 feet)
apart. When there are two interviewers, the primary
interviewer should be seated slightly closer to the
interviewee and the secondary interviewer a little farther
away and out of eye contact with the interviewee.
There are always occasions when, for whatever reason, only one
investigator will conduct an interview. The single-interviewer
interview is the most difficult because it requires one investigator to
do it all. A major drawback is that it automatically creates the
barrier of notetaking which distracts both people. The interviewee
may feel that his or her needs are, not being attended to, or may
actually become overly interested in what is being written. The
investigator may also become overloaded and miss information by
failing to listen or failing to see what is communicated. Suggestions
for note taking when one investigator is interviewing include taking
abbreviated notes during the questioning phase, taking notes only
during the summary phase, and taking notes immediately following
the interview. Each investigator will have to determine what works
best for them.
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ELICITING INFORMATION FROM RELUCTANT WITNESSES
Because investigative interviews delve into feelings, attitudes, and
reasons for actions, they often hit raw nerves and evoke reactions
ranging from tears to hostility. To elicit information from a
reluctant witness is a complex process; there are no hard and fast
rules. The investigator must merge a variety of "people skills" such
as the use of persuasion, influence, patience, persistence,
objectivity, flexibility, control, and confrontation.
If an interviewee seems unwilling, or unable to talk, try to
determine why. The person may be inhibited by the investigator,
the situation, the topic, the surroundings, other people, etc.
Sometimes reluctance cannot be overcome during the interview.
You might change your style (from formal to informal, or cool
professional to warm friendly) or your questioning strategies. As a
rule, to encourage a friendly witness to respond, the investigator
should ask general, non-threatening questions until the person has
warmed up and is ready to give answers. Use silence to encourage
the interviewee to talk, head nods to keep them talking, and good
listening techniques to show empathy and interest. Active listening
can assist in overcoming reluctance and hostility, and in
determining how and when to confront the interviewee with
inconsistencies.
Interviewees often try to evade questions that force them to reveal
inner feelings or prejudices, take stands, give specific pieces of
information, or incriminate themselves. Evasive strategies they may
use include humor, "put on" hostility, counter questions, requests
for rephrasing and giving a rationale for a question. The person
may also give long answers that provide little information or dodge
the issues.
If you detect hostility, try to determine first if it's real (or merely
your perception) and second, its cause. A person may feel angry,
depressed or helpless because of the circumstances, and the
investigator becomes a convenient target for releasing feelings.
Hostility may be directed toward you, your organization, your
position, your profession, or the requested information which is
seen to be damaging to the person if revealed. When a witness is
concerned with confidentiality, advise them that the information
will be used for "official purposes only." You cannot promise
complete confidentiality; little is confidential in a law enforcement
interview. The investigator never knows what the attorney may do
with information that is forwarded to him. The only promise you
can make to a suspect is: "I will bring your cooperation to the
attention of the U.S. Attorney."
Bad experience with investigators may lead the interviewee to
expect the worst from you. An interviewee may become hostile due
to the timing of the questions, words used, or the nonverbal
messages, or because he feels he has been pushed too far. Be
careful of unwarranted pressure tactics. Allow a hostile interviewee
to blow off steam while you remain friendly and non-defensive.
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Confronting Interviewees
Background information plays a key role in determining your
approach to successfully gain cooperation, obtain information, and
determine when and how to confront. You must have things
correct in your mind—it doesn't work when you just think you are
right. You must have the facts to effectively confront someone
with inconsistencies, contradictions, and deceit. The following may
help:
*• Confrontation in the interview follows a similar continuum
as that of the patrol officer determining appropriate use of
force. Generally, we start at the low end of the continuum
and step up the intensity as the situation warrants.
* Sometimes, it may be necessary to begin confrontation at a
higher point on the continuum. Start at a point just under the
level of resistance of the interviewee and increase the
intensity as necessary.
*• Picture the interviewee as a candle flame. Your approach
should be geared to the level of that flame. As the flame goes
higher, so does your level of confrontation; as the flame
decreases, so does your level of confrontation. Try to stay
one step lower than the interviewee.
It often helps to confront lies immediately. That way, hostility has
little time to build. But, you must be positive that the statement is a
lie; when you are wrong, you lose your credibility and perhaps,
control.
Be flexible in your approach and in the techniques used. When
determining your course of action, remember that as a rule, a
reluctant or hostile person will not give up information to an
investigator he doesn't like or respect.
USING AN INTERPRETER IN INTERVIEWING
When you use an Interpreter in interviewing, it is important that
this person be fluent in the exact dialect spoken by the subject.
Mere foreign language training in school is usually not enough. It is
also unsatisfactory to use a person who has a poor command of
English. The interpreter must know your language well enough to
understand exactly what you wish to convey. He or she must have
sufficient vocabulary and knowledge of sentence structure in both
languages to make an accurate translation. He or she must be able
to reflect the attitude and manner of expression as well as the
information itself.
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The interpreter must accept the subordinate role in the interview.
He or she must remain passive, translating only what is said by
both parties, without clarifying or explaining questions and
answers. The interpreter should have a positive reputation in the
community, be honest, and free from any involvement in criminal
activities.
The interpreter may be seated beside you or between and to the
side of the parties. The interpreter will only need to turn his head
when addressing either you or the subject. Do not allow the
interpreter to move around or distract the subject as this may harm
the interview process. Continue to watch the subject while the
interpreter is talking; it is imperative to observe the subject's actions
and reactions before, during, and after the translation of the
question.
In advance, prepare clear, concise, simply-stated, and anger-free
questions. Lengthy or complex questions are more difficult to
translate and should be avoided when possible.
*• Brief the interpreter prior to the interview and away from
the subject. Advise of the methods and procedures you plan
to follow.
> The interpreter shall merely act as a vehicle for accurately
interpreting and passing the information back and forth
between you and the subject.
> The interpreter shall imitate your voice inflection and
gestures as much as possible.
> There shall be no conversation between the interpreter and
the subject other than what you tell the interpreter to say.
> No matter what the subject says, the interpreter must pass it
on to you verbatim rather than evaluate its worth himself.
This includes even the most trivial remarks or exclamations.
> The answer the interpreter gives you must be an exact
translation of what the subject has said. If the answer is
unclear, you shall then ask, through the interpreter, for a
clarification. The interpreter shall not, on his own initiative,
attempt to explain responses or ask the subject to elaborate.
> The interpreter shall refrain from using "add-on" phrases
such as "he says...", "he claims...", or "I believe he is lying." If
the interpreter's opinion is desired, based upon his/her
knowledge of the subject's culture, value system, and body
language, that opinion should be requested in private after
the conclusion of the interview.
* As the interviewing agent, you shall address the subject
while looking directly at him rather than at the interpreter.
Continue making eye contact with the interviewee while
asking the question slowly, clearly, and in plain English.
Even if the subject has some knowledge of English, or you of
the subject's native language, you shall use the interpreter
Appendix B • FIFRA Interviewing Techniques • B-26
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for all questions and answers once the decision has been
made to use an interpreter. This consistency will help avoid
misunderstandings and avoid confusion as to whom the
subject should answer.
In spite of the difficulties involved in using an interpreter, very
successful interviews can be conducted, provided they are well-
planned and controlled. If possible, you may wish to record the
interview for more accurate documentafion and as a checking
mechanism for the interpreter.
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REFERENCES
Argyle Michael, and J. Dean. "Eye Contact, Distance, and Affiliation." Sociometry 28 (1965): 289-304.
Baldwin, Scott. "Cross-Examination: The Old Rules Are Still The Good Ones." Trial July 1987: 76-81.
Barkai, John L. "How to Develop the Skill of Active Listening." The Practical Lamer 30.4 (1984): 73-84.
Buckley, Joseph P. and Philip A. Mullein. "The Use of Behavior Symptoms in the Search for the Truth: A Tool for the Prosecutor."
The Prosecutor (Spring, 1985): 41-44.
David, Joseph A. Human Communication: The Basic Course. 4th ed. New York: Harper and Row, (1988).
Dudley, Robert J. Think Like A LaMer. Chicago: Nelson-Hall, (1980).
Elman, Paul. Telling Lies. Springfield. Charles C. Thomas. (1986).
Fisher, Ronald P., R. Edward Geiselman, and David S. Raymond. "Critical Analysis of Police Interview Techniques." Journal of
Police Science and Administration 15.3 (1987): 177-185.
Fleming, Vic. "Ferreting Out Falsehoods." Arkansas LgWer (Jan. 1986): 7.
Garden, Raymond L. Interviewing: Strategy, Techniques, and Tactics. 4th ed. Chicago: Dorsey Press, (1987).
Hall, Edward T. The Hidden Dimension. New York: Doubleday, (1966).
Hailin, Sonya. What Makes Juries Listen. Clifton: Law & Business, (1986).
Inbau, Fred E., John E. Reid, and Joseph P. Buckley. Criminal Interrogations and Confessions. 3rd ed. Baltimore: Williams and
Wilkins, (1986).'
Johnston, Michael W. "Cross-Examination of the Accused." The Air Force Law-Review 27 (1987): 133-140.
Kestler, Jeffrey L. Questioning Techniques and Tactics. Colorado Springs: Shepards-McGraw-Hill, (1982-1989).
Litigation Sciences. "The Social Psychology of Persuasion: Courtroom Applications." For The Defense (April 1984): 10-16.
Lopez, Felix. Personnel Interviewing, New York, McGraw-Hill Book Company, (1975). Mahl, George F. Explorations in Nonverbal
and Vocal Behavior. Hillsdale: Lawrence Erlbaum, Assoc., (I 987).
Malandro, Loretta A., Larry L. Barker, and Deborah Ann Barker. Nonverbal Communication. 2nd ed. New York: Random House,
(1989).
Miner, Edgar M. "The Importance of Listening in the Interview and Interrogation Process." FBI Law Enforcement Bulletin (June
1984): 12-16.,
Rasicot, James. Winning Jury Trials. Minneapolis: AB Publications, (1983).
Riley, Tom. "Cross Examination: The Art of Gentle Persuasion'." Trial..Diplomacy Journal (Spring 1983): 22-26.
Roberts, Margaret C. Trial Psychology: Communication and Persuasion in the Courtroom. Austin: Butterworth Legal, (1987).
Royal, Robert F. and Steven R. Schutt. The Gentle Art of Interviewing and Interrogation. Englewood Cliffs: Prentice Hall, (1976).
Smith, Lawrence J. and Loretta A. Malandro. Courtroom Communication Strategies New York.- Kluwer Litigation Library, (1985-
1987).
Stewart, Charles J. and William B. Cash, Jr. Interviewing Principles and Practices. 3rd ed. Dubuque: William C. Brown, (1982).
Willet, Tom H, "A Matrix of Meaning." Journal of Missouri Bar (June 1985): 249-255.
Yeschke, Charles L. Inter-viewing, An Introduction to Interrogation. Springfield: Charles C. Thomas, (1989).
Appendix B • FIFRA Interviewing Techniques • B-28
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APPENDIX C
FIFRA HIGH
VISIBILITY INCIDENTS
INTRODUCTION
This appendix was developed to address the management of high
visibility incidents relating to the use of pesticides. The misuse of
methyl parathion in Regions IV, V, and VI is used as an example
throughout this manual; however, we believe that the information
contained herein can serve as a guide for a variety of high visibility
incidences.
INTERAGENCY COORDINATION
Coordination with Other Entities
A great deal of coordination takes place between EPA and
State/local entities before, during, and after a misuse event.
Success depends on close working relationships established before
any inspectional activities begin. Ideally, an interagency task force
or workgroup should be established to alleviate confusion and
rivalry among the respective participants. Memoranda of
agreement (MOAs), flow charts, and written directives enhance the
communication, outreach, and overall efforts of any operation. In
many cases, local governments rely solely on the expertise of the
State and federal authorities. In almost every situation each agency
compliments and enhances the overall effort when effectively
utilized and incorporated into a holistic approach.
Defining Jurisdiction Issues in Advance
It is unrealistic to expect that jurisdictional issues and questions will
not arise during the initial phases of the operation. Some effort,
therefore, should be made by each affected regulatory and
community-based organization to define jurisdictional issues
beforehand. Although complete agreement may not be reached by
all the parties on each issue, all will come away with the same
expectations and a clear understanding of their respective roles. In
some high profile events, local agencies and community
organizations can serve as effective conduits of information to
assist federal and State regulatory personnel. Local government
agents have a sense of perspective and can often provide immediate
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logistical and personnel support. How charts are an easy and
inexpensive way for federal, State, and local entities to depict their
respective responsibilities, transfer of information, and
jurisdictional issues. How charts also help dramatize how the
process unfolds from initial discovery, investigation, sampling,
testing, and final dispensation of each respective party.
Federal
Each federal agency shall review their existing MOAs and
interagency agreements to clarify the respective roles and
responsibilities. The federal participants should respond as
requested and foster cooperative relationships with other federal
counterparts not only for the smooth transition into and out of an
event but to provide leadership. It is counter productive for State
and local entities to observe federal entities squabbling over
jurisdictional issues when a crisis situation merits their primary
attention. With respect to the misuse of methyl parathion, the
regional and HQ pesticide programs should establish reporting
mechanisms and identify contacts to exchange information and
receive technical advice. Likewise, each regional pesticide program
shall coordinate roles and responsibilities between the regional
emergency response teams (SUPERFUND), health and toxic
substances agencies such as the Center for Disease Control (CDC),
Agency for Toxic Substances Disease Registry (ATSDR),
Department of Justice (DOJ), Federal Bureau of Investigation
(FBI), and the Attorney General's Office (AG), as appropriate.
State
The coordination of State regulatory programs is just as important
to the overall management of an event as the federal program.
State agencies shall initiate and foster close working relationships
with local authorities as appropriate to accomplish the mission.
Periodic meetings shall be held with local agencies to clarify roles
and responsibilities and to keep State and local personnel informed,
as appropriate.
Status Reports: State to Region, Region to HQ
A mechanism shall be established to provide daily reports to the
State, region, and headquarters offices.
COMMAND CENTER
Establishing a Command Center
The need to establish a command center to address and coordinate
the inspectional and environmental sampling activities depends
upon the nature and the level of the incident. Flow charts are an
easy and inexpensive way for federal, State, and local entities to
depict their respective responsibilities, transfer of information, and
jurisdictional issues. The command center shall address many
needs including meeting sites, database management, supply storage
and distribution, inspector coordination, and records maintenance.
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Location
The location shall be in close proximity to the affected area to
reduce travel time for the inspection.
Expenses
Expenses to consider include the cost of acquiring a command
center. Other expenses might include the following:
*• Office supplies.
> Film and processing.
> Printing.
*• Inspection/sample supplies.
*• Shipment of samples.
* Computer/FAXes/printers.
* Cellular phones and paging service.
*• Telephone service for voice and fax.
*• Laboratory costs.
* Blood analysis (base lines for inspectors as appropriate).
* Meals/lodging/gasoline.
*• Mileage.
*• Air travel.
> Overtime/Compensatory time.
* Field, administrative, clerical and data management staff
assistance costs.
Facilities
If the facts of the case determine there will be a need to conduct
numerous pesticide inspections over a long period of time,
management should choose facilities to serve the purpose but
reduce the cost over an extended stay. Facilities that could serve as
command centers include army barracks, National Guard armories,
vacant hospital wings, fairgrounds, and church recreational and
Sunday school classrooms. Local police departments, emergency
response agencies, municipal buildings and libraries also offer
alternatives to hotels and resorts. Short term leases on
condominiums and apartments may be practical.
Equipment/Resources
The command center shall serve as a meeting place for all
regulatory personnel and their guests including the local and
national press, local agency personnel, members of the community,
activists groups, and other law enforcement personnel. The ideal
command center accommodates a database system to collect and
tabulate inspectional activities, allows for storage of sampling
equipment, inspection forms, samples ready for analysis, containers
collected on inspectional visits, printers, telephones, rechargeable
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pager stations, fax machines, empty boxes to ship samples, and a
central bulletin board to announce meetings, inspection requests
and important interagency information. Samples and inspection
equipment, databases, and files should be in a secured location to
ensure evidence integrity.
Establishing Contacts/Phone Logs
A telephone and contact sheet or book should be developed as
soon as possible and should include primary and secondary
contacts for every agency involved. All inspector names should
also be included with phone, pager, and credential numbers.
ADMINISTRATIVE SUPPORT
Use of Administrative/Support Staff Personnel
Depending on the size of the event, it may be useful to utilize
administrative or clerical support staff to help manage the
command center. Administrative staff can fax, enter data,
coordinate the submission of samples to the laboratory, coordinate
couriers and Federal Express, answer phones, order supplies, sign
for deliveries, copy forms for the inspections, index case files,
provide security for investigation files, run errands, and arrange
meetings, etc. When these activities are conducted by support staff,
management and the inspection teams can focus on the overall
operation and investigation activities.
Data Entry Personnel
If the size of the event warrants it, a database management system
and a data entry person in the field to enter the data may be used.
At least two other individuals at the site shall be familiar enough
with the database system to operate and/or produce needed reports
as necessary. The database systems can be used to capture the
investigatory data and can be used interchangeably with existing
State and federal database systems.
LABORATORY SUPPORT
Courier Services for Lab/Back-up
Arrangements should be made to cover sample delivery to the
appropriate laboratory for analysis.
HEADING TO THE FIELD
Managing Inspectors in the Field
(Management)
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State and federal management shall resolve issues of authority and
chain of command as soon as possible. Inspectors shall hear one
consistent voice controlling the investigation. Inspection
procedures and respective authorities shall be provided in writing
and shall be fully discussed with all investigators. Once the
designation of additional persons in authority becomes necessary,
the respective authorities must be explained to all. For the sake of
team morale and consistency, no local deviations from written
policy shall occur.
Arriving at the Site on Day 1 (Management)
Prior to initiating any inspections, inspection protocols shall be
determined and adequate supplies and safety equipment must be
obtained to cover an anticipated number of inspections. Facilities
need to be located to store supplies, provide administrative support
to the investigators (phone, FAX, copier, computers and printers,
etc.), and provide an assembly area for briefings, sample
preparation, and report writing.
When these logistics have been resolved, a meeting shall be held to
explain the mission; copies of the authority policy shall be
distributed along with the inspection/safety protocols and both
shall be discussed thoroughly. After all these things have been
decided and discussed, inspections may begin.
Arriving On-Site (Public Relations/Press
Personnel)
As soon as warranted, a plan for press/media details shall be
developed and a media person designated to be the primary
contact. Investigators shall not have contact with the media unless
it is coordinated through the media specialist and command
management.
Getting Started
Upon arrival at the command center, inspectors shall notify the
appropriate personnel of their arrival, make arrangements to team
up with a lead inspector, collect their supplies and assignments, and
begin conducting site visits. Management shall put together a quick
orientation guide for incoming personnel. Each inspector shall
take the time to read the information presented in the orientation
guide before beginning site visits.
Each inspector shall acquire a baseline blood examination and
respirator FIT test, where applicable, before entering the field to
conduct investigations. Also, each inspector shall team up with at
least two other "seasoned" EPA and/or State pesticide inspectors
who have been in the field conducting these investigations and who
have inspector credentials. Once each inspector's training is
complete, teams of two shall be formed. Designate a vehicle that
each team will be using to conduct the investigations and place the
proper equipment in an organized fashion in this vehicle. The
teams shall refer to the supply list manifest and safety equipment
listing as a guide. Each team member shall determine his or her
duties prior to each site visit to avoid confusion and to expedite the
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investigation. Since each team will consist of two individuals, it
may be beneficial for one team member to conduct the interviews
with each resident and to prep and wrap the samples. The second
team member may collect the samples, assist with sample prep, and
fill out the Receipt for Samples, collection reports, and chain of
custody. The second team member may also collect the proper
documentary or physical samples and exhibits for inclusion in the
case file.
Credentials
If an inspector or office staff person does not have EPA or State
credentials, then he/she should team up with someone who does.
The individual who has the credentials will act as the 'lead'
inspector on a team and all inspections will be done under the
lead's credential number. This number will go on all samples,
official sample seals, and investigation reports, etc. as appropriate.
INSPECTIONS
Assignments
Assignments are prioritized and assigned at the end of the day to
facilitate contact with residents the night before an inspection/site
visit. Priority shall be given to households which have children and
the elderly as primary residents and/or who have reported adverse
health affects symptomatic of the respective pesticide in question.
The local health department may be able to assist in the
prioritization process.
Contacting Residents for Site Visits
The night before the site visits, each team shall try to contact
residents whose homes they intend to inspect. In many cases, the
residents will not be home and several calls will be necessary to
make contact with the homeowner/tenant. Teams may elect to use
cellular phones on the road to contact residents, clarify directions
to a site, and to notify residents of delays.
Day Care Centers/Restaurants
If a team receives an assignment to inspect a restaurant, day care,
nursing home or any other kind of facility which they believe may
be regulated by the Health Department, they should speak with the
Officer in Charge about making arrangements to be accompanied
by a representative of the Health Department. This procedure shall
be determined by management ahead of inspection assignments.
The Visit/Inspection
Upon arrival, proceed to the main entrance of the residence, knock,
present your credentials, and introduce the team members. One
team member may elect to introduce both individuals and tell the
resident the reason for the visit. The resident shall also be apprized
at this time how each team intends to inspect/sample the home
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(i.e., Inspector Brown will interview the residents and prep the
samples while Inspector Smith will dress out in safety gear and
enter the home for sampling purposes). After a through walk-
through has been completed by the sampling team, tell the resident
how many samples the team intends to take and where the samples
will be collected.
Length of Inspections
The length of the inspection and sampling depends on the amount
of information needed to document the application and collect
environmental samples. If official statements are required, the
process may be further delayed.
TEAMS
Organizing the Team's Vehicle
Prior to leaving to conduct site visits/sampling initiatives, each
vehicle should have the appropriate supplies. Each team shall take
enough supplies to cover those instances where additional sample
collection is necessary and/or some element of the investigation
needs to be repeated because of mistakes, etc. The team shall take
time at the end of the day to reorganize the vehicle and collect
additional supplies so the team can leave for site visits as soon as
possible the next day.
Establishing Limits/Time Frames and Check-ins
for Inspection Teams
At the end of each day, teams shall report to the command center
at a pre-established time. One-half hour before dusk insures the
safety and accountability of the teams in the field. The teams shall
leave enough time to get samples into the command center and
prepped and ready for the courier or transfer to the laboratory.
Inspectors shall also plan enough time to write inspection reports,
eat dinner, conduct daily meetings, and have time to relax.
Setting Up Inspections By Zone in
Communities
Individuals responsible for the inspection assignments shall acquire
several city and local maps and use them to break each location into
distinct zones. These zones can be used to assign hotline calls to
inspection teams so that teams can become familiar with their
respective territory and so that there is no overlap in territory with
inspection teams crossing each other paths.
Team Meetings
Team meetings shall be held regularly to facilitate communication
and direction of the exercise. Team meetings/briefings shall be
mandatory for every inspection team unless otherwise directed.
The team meetings/briefings are an opportunity for disseminating
the latest information, discussing inspection procedures, and
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exchanging information on the latest complaints /numbers. Each
meeting shall also address any relevant safety issues.
INTERVIEWING TECHNIQUES
Interviewing/Conversations with the
Resident(s)
Each site will be different and the response each team receives
from residents involved may differ dramatically. Some residents
will be open and friendly while others may be reclusive and non-
committal. Many residents will ask how long the procedure will
last and when they will be notified of the results. Also, the team
shall be aware of their facial expressions and comments over the
quantity of pesticide residue they encounter in the home. Many of
these residents have not even noticed the tell-tale signs of staining,
streaking, etc., and the team shall not elevate their anxiety level by
making untoward comments. Each resident will respond to the site
visit in a different way. Try to avoid situations where the team
makes vocal observations about the residence, education level of
the residents, and/or the appearance and cleanliness of the
structure.
Answering Questions from
Homeowners/Tenants about Health-Related
and Remediation/Relocation Issues
The responsibility of the pesticide investigation teams is to
document the use of pesticides. It is not the responsibility of any
member of a pesticide team to explain short term and/or long term
health affects or to commit to remediation/relocation inquiries.
Health officials and Emergency Response personnel
(SUPERFUND) are directly responsible for these types of
inquiries. Pesticide staff shall, however, be as courteous and
responsive to resident inquires and concerns as possible. In many
cases, the investigators are the first persons the resident contacts
regarding pesticide sampling and their anxiety level may be high.
Inspectors may provide the resident with a brief introduction of
roles and responsibilities so that the homeowner understands why
the inspection team is there, the scope of the team's duties and
what the team will be doing while visiting the home. Based on the
information collected during the Mississippi and Tennessee
initiatives, the following lists the most common questions from
residents:
Question: Why are you wearing moon suits to enter my home
when my children are crawling around on the floor?
Answer: Since our investigation teams are visiting numerous
homes and may be exposed to varying levels of the chemical, it is
agency policy that they be protected accordingly. It does not mean,
however, that your home has high levels of the compound. The
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suits prevent contamination from one home to the next since we
are visiting a number of homes and do not know contamination
levels prior to sampling.
Question: When will I know the results of this
in ve s tigation / s ampling?
Answer:(Note: work out a standard and consistent reply that
reflects not only your programs opinion but those of the laboratory
assigned to conduct the analysis). A standard answer may be
"within two weeks we should have your results.
Question: Who will notify me of the results?
Answer: The health officials that are working with us will notify
you. This is most likely the last time you will see a pesticide
program inspector regarding this particular incident.
Question: Should I move my family out?
Answer: You should wait until all the analytical work is complete
and you have spoken to the appropriate authorities before making
such a decision.
Question: Should I clean up where the chemicals were sprayed?
Answer: No, if you attempt to clean the treated areas you may
increase your exposure to the chemical.
Supplies
Inspection Forms
*• Notice of Inspection
* Receipt for Samples
*• Resident questionnaires
*• Statements
* Medical Release Forms
* Sample Collection Reports
> Chain of Custody Forms
*• Pesticide Fact Sheets
Sampling Supplies
*• Disposable latex or vinyl gloves.
> 3x3 inch cotton gauze (swabs).
* Solvent - Isopropyl alcohol- reagent grade.
* Templates - 10cm x 10cm.
> 9 ounce glass jars with screw top lids.
*• Labels for identification of sample jars.
* Polyethylene bags (8 x 24) used for shipping samples to lab.
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*• Polyethylene bags (12 x 30) used for collection of (8 x 24)
polyethylene bags containing official samples and small
pesticide containers.
> Official sample seals.
*• Squeeze bottles for isopropyl alcohol.
> Tin foil.
> Black garbage bags for trash and to collect large evidence.
> Filament tape for sealing sample bags.
*• Camera with flash.
*• 200/400 speed film for camera.
> Flashlight.
Writing Supplies
*• Black sharpee markers
> Black ball point pens
* Blue ball point pens
Safety Equipment
*• Tyvex suits
* Tyvex booties
> Full-face respirator(s)
> Half-face respirator(s)
* Latex/vinyl gloves
* Respirator replacement cartridges
Other
*• Watch
* Cellular phone/Pager
*• Clipboard
*• Water/ice chest for samples
File Assembly Materials
*• Manilla folders
*• Paper for assembling photographs
*• Stapler
SAMPLING
On-Site Sampling Procedures
Each residence shall be sampled using the same procedure. A total
of five samples shall be collected at each site unless the conditions
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dictate more or less. The first sample (01) shall be a blank and is
used to show that the sampling prep area/procedures are not
contaminated; sample (02) consists of a composite sampling of the
kitchen (3 gauze); (03) shall be taken under the kitchen sink; and
(04) and (05) shall be taken in a bathroom, infants
playroom/bedroom, family room, pantry, etc. The inspection team
shall interview the residents to determine where the applicator
made the applications and where children reside to make the best
use of samples (04) and (05).
Upon arrival, at least one team member shall begin sample
preparation after the initial introductions have been conducted.
Begin by removing five pieces of tin foil in 12 x 12-inch sections.
Then, remove five clean, glass jars from storage and place them on
the pieces of tin foil. The tin foil serves two functions: it protects
the sample jar/gauze from any contamination that is present on the
surface where the samples will be prepped and it ensures the
integrity of the samples once the sampler enters the residence and
removes the swabs from glass jars before sampling locations in the
home.
Sample preparation continues with the identification of the sample
jar labels and the 10cm x 10cm templates. Each sample jar label
and template must have the same identification number (i.e.,
112096 11990 0101). This number reflects the date of the
inspection, the inspectors credential number, and sample sequence
(first inspection, first sample collected). Sample preparation
continues with saturating each sample with isopropyl alcohol. The
sample prep team member shall remove 1 gauze pad (while wearing
gloves), fully saturate the gauze and place it in the glass jar that will
represent official sample number 01. After this sample has been
prepared, the sample prep person then removes their gloves that
they used for the first sample and puts on a new set of gloves to
charge the remaining four sample jars.
Once the sample jars are ready, the sample prep person can remove
five, 8 x 24-inch polyethylene sample bags, identify each with an
official sample collection number, and invert each bag to
accommodate the samples collected. While the sampler is
collecting samples from the home, the sample prep person can
generate official sample seals, tape the 8 x 24 inch sample bags, and
set out the black garbage bag for collection of used template,
gloves, tin foil, tyvex and booties. Also, the sample prep person
can interview the homeowner/tenant while the sampler is
conducting his or her sampling inside the home.
As the sampler exits the residence, the sample prep
person/interviewer shall open the respective polybag that matches
the sample jar and have the sampler place the jar in the bag. The
sample prep person can then tie, tape, and seal the sample bag.
Once all sample bags are ready they can be placed in a 12 x 30-inch
polybag for transfer to the command center and to the federal
and/or State laboratory. Each team shall remember to fill out the
collection report for inclusion in the bag as well as the Chain of
Custody form that will accompany the samples.
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The Sampler
The sampler has a considerably more hazardous job than the
individual who remains outside to interview the resident, prep and
collect the samples from the sampler. The sampler shall wear, at a
minimum, a half-face respirator, tyvex suit, gloves, and booties.
The sampler can also photograph the sample site (template) before
he swabs the effected area. The sampler shall begin outfitting as
soon as the introductions are concluded with the homeowner. The
sampler shall indicate to the resident that the use of protective
equipment does not indicate that the residence is contaminated and
only that it is Agency protocol. The team may also add that since
the teams are visiting numerous residences day after day, that the
potential for increased/elevated exposure levels is possible and the
equipment protects both the sample and the sampler.
Once inside the sampling site, the sampler shall remove the charged
gauze pad from the clean glass jar and with it folded in-half, wipe
five times horizontally top to bottom inside the template.
Templates shall be identified properly, (identified with official
sample number) and placed in the location of the sample collection,
photographed and used to designate the sampled area (i.e., 10cm x
10cm area). Turn the swab over and swab vertically five times
across the inside of the template. At the end of this step, the
sampler will be left with two potentially contaminated (used) sides
of the cotton swab. The contaminated sides should be folded onto
themselves leaving two unused sides for two more applications to
the area in question. Again, repeat the same procedure first
horizontally, then vertically inside the template. Once sampling is
concluded, immediately place the swab in the glass jar with the
sampling hand, seal top of jar and exit sampling site. Repeat the
same procedure used for all swabs, including the composite sample
where two more samples will be taken in the kitchen before exiting
site. Repeat the same procedure used for the first swab except at
two other locations in the kitchen. Place the swabs back in the
clean glass jar, apply the lid, and take to the sample bag located
outside the residence.
The sampler is responsible for the collection of samples 02-05.
The sampler may collect additional samples as warranted. Sample
02 should be taken entirely from the kitchen and will represent
three gauze wipe samples taken from hand-picked locations in the
kitchen. Sample 03 will be drawn from under the kitchen sink.
Samples 04 and 05 will be drawn at the discretion of the sampler
but should be focused on the infants bedroom, bathroom, other
family bedrooms or high-traffic areas such as the family
room/dining room.
Preparing Sampling Bags for Transport
Once all sample bags are ready, they can be placed in polybags for
transfer to the command center and on to the federal or State
laboratory. The Investigation Summary or Sample Collection
report shall be placed inside the bag with all the samples from a
single site. The team shall also complete a portion of the Chain of
Custody form that can be placed in a box at the command center.
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This form will be completed by the person (s) (courier service)
transporting the samples to the analytical laboratory. (Note: This
procedure is only to be used if the 'lead management" agrees with
these procedures. Otherwise, use the other procedures as described
in other chapters of this manual for sampling.)
Drawing Sub-Samples after Warrants are
Completed/Acquiring a Facility to Pull Sub-
Samples
During a search/arrest warrant exercise, there may not be enough
time or the conditions may hamper efficient sub-sampling activities.
The team shall designate a location away from the applicators home
or place of business to collect sub-samples of the chemical
compounds confiscated during the search. Sub-samples shall be
drawn using established federal and State procedures and/or using
the NEIC sampling guide.
Storage Facilities for Containers Collected
during Inspections
The pesticide investigation command center management shall
determine a suitable place for the storage of pesticide containers
collected during the investigations. Pesticide containers shall not
be stored at the command center for extended periods of time.
These containers shall be identified, bagged, photographed, and
logged into the system and then transported to a secure facility for
storage.
Chain of Custody Issues for Samples/Time
Frames for Sample Submission
Chain of custody forms will need to be utilized to ship the samples
via inspector/courier to the respective laboratory for analysis and
to place confiscated containers and pesticide receptacles into
custody. These form shall have at a minimum the following
information:
*• Program
*• Official sample number(s)
* Compound to be analyzed
* Sample type(s)
*• Name of person relinquishing sample(s)
> Name of person accepting sample(s)
*• Date
> Time
*• Type of packaging
> Where the container(s) are to be stored
Disposal of Used PPE and Sampling Equipment
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Depending on the degree of contamination and number of
pesticide investigations/environmental sampling events that are
conducted, an acceptable method of PPE and sampling equipment
disposal shall be determined. Inspection teams shall not leave their
used safety equipment and sampling supplies at the sampling site
nor shall they dispose of these items in an unsafe manner at the
command center. In certain situations, the emergency operation
component of the operation (SUPERFUND) may have access to
dumpsters positioned at the remediation sites or have a place
prepared at their command center for disposal of these items. If
the remediation/relocation phase of the operation has not started, a
suitable alternative should be arranged.
Respirators
Because each team will be inspecting sites which may have high
levels of methyl parathion or other agricultural chemicals,
respirators should be used while inside these structures. Each
inspector shall be fit tested for an appropriate respirator by his/her
safety officer. Full-face and half-face respirators come in different
sizes and accommodate any size facial feature except those who are
not clean shaven. Respirators shall be cleaned at the end of each
day.
INSPECTION REPORTS
File Assembly/Sample Submission
Each file shall have a completed Notice of Inspection, Receipt for
Samples, questionnaire, and original complaint form. The type and
peculiarity of the file may warrant the collection of statements,
medical release forms, and additional photo-documentation. The
team shall be cognizant of the daily status of the general
investigation so that any new inspection procedures are included.
At the end of each day, the team shall complete a file folder cover
with the following information:
*• Name
> Address
> Phone
> Number of residents, adults, children, and pets
> Name of applicator
* Inspection date
* Treatment date
The information on a folder cover is entered into a database which
may be used by Emergency Response and the Health Department
to contact families requiring relocation. Even if the team has not
finished all the paperwork for the inspection, the folder shall be
completed and entered into a database. Photographs and other
information can be added at a later date as the team completes their
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reports. Since conducting a number of inspections during a
relatively short time frame, inspection reports need to be completed
daily. This will prevent confusion between inspections or locations.
Notice of Inspection
The Notice of Inspection shall include the following information:
> Name of the individual.
> Address of the State or federal EPA office.
*• Title of individual.
*• Address of the individual.
* Date and time of the inspection.
* Signature of the EPA or State inspector.
*• Title of the State or federal representative.
*• Under "Reason for Inspection" - "For the purpose of
inspecting sites where pesticides have been used to
determine whether the pesticides were used in compliance
with FIFRA/State law" should be checked.
* Under "Violation Suspected" - "None by subject" (if
homeowner/tenant) and "Possible misuse of a pesticide."
* Check the "voluntary consent" box.
> Indicate inspection site (i.e., home, apartment etc).
*• Signature of inspected party, title and date.
Receipt for Samples
The Receipt for Samples shall include the following:
> Name of the individual
> Address of the State or federal EPA office
*• Title of individual
*• Address of the individual
* Date of the inspection
* Signature of the EPA or State inspector
*• Official sample number(s)
Language used in the body of the Receipt for Samples shall
accurately describe where each sample was collected (i.e., under the
kitchen sink, from base molding on the left side of refrigerator,
from the back splash directly above bathroom vanity, etc.). Each
swab area shall be calculated such as 100 cm squared and a total
area if the swab represents more than one application site.
Questionnaires
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Questionnaires are an effective and efficient means of acquiring
information from each person inspected. It is best for the entities
responsible for the investigations develop questionnaires specific to
the investigation to assure uniformity and consistency by the
inspectors. Some of the information collected by the pesticide
inspectors may be very useful to health officials and emergency
response officials. Questionnaires shall include the following
information:
*• Date.
*• Inspector(s).
*• File Number.
> Name of inspected party, address, home and work phone.
* Type of structure (house, trailer, church).
> Name of applicator.
> Date of LAST treatment.
* Total number of treatments by the applicator.
> How the person heard about the applicators services.
*• Receipts, business cards, invoices etc.
*• A pesticides left on site (either sold or free of charge).
> Description of container.
> Any self-applied material/applications.
*• Names of all persons who witnessed the application(s).
> Areas of structure treated.
* Verbal claims/precautions issued by applicator to resident.
* Other pest control companies employed at this residence.
> Number of occupants broken down by adult/children/ages.
*• Property owners name, address and phone.
> Adverse health effects noted immediately following
application and over time.
* Other information/comments.
Statement
The statement is an important tool to lock in the observations and
statements of the person interviewed during the investigation.
Before beginning, obtain all the pertinent information on the
questionnaire and/or a field notebook. Record the information on
a statement form and have the complainant sign and date it. It is
highly recommended that the inspector write the statement in the
complainant's words. The statement shall address the following
areas:
* Complete name, address and phone number of complainant.
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*• Owner of property, name, phone number and address.
*• Nature of the complaint.
> Name of individuals or company which applied or sold the
pesticide(s), date and time of application and/or sale and
name(s) of the pesticide(s) used if available.
*• How the complainant found out about the
applicator/distributer in the first place?
*• Date and time complainant first observed problem/damage?
> Where the applicator treated the home, kitchen, bath etc.?
> Did homeowner witness applicator mixing product and
what if any safety equipment he or she wore while the
application occurred?
> Did the applicator give any verbal warnings, provide
instructions to resident?
> Did the complainant use any other pest control service
before or after the application in question?
> Did the complainant purchase any material and/or use the
material inside the residence and where?
> Timing and description of adverse health affects to any
member of family?
* Method of payment?
* Were receipts, business cards, invoices provided?
> Any attempts by homeowner to dean up the treatment sites?
> Any friends, acquaintances, business associates who used
the services of the applicator in question?
Physical Samples
Most of the physical samples collected take the form of individual
and/or swab samples (3"x3") and containers either holding a
suspicious pesticide compound or pesticide material left behind by
the applicator. As discussed in the sampling section, swab samples
shall be placed in clean, glass jars, sealed, and polybagged in an
appropriately sized polybag (i.e., 8x24 or 12x30).
The bag shall be sealed with an EPA Official Sample seal,
identified, and then inverted to assure sample integrity. The
containers collected shall be double polybagged, identified, sealed
and placed in an area of the vehicle that is removed from the swab
samples. The inspection team shall take along several extra
strength garbage bags to store two to five gallon pesticide spray
containers and other large pesticide jugs that cannot be
accommodated by standard polybags. Physical samples shall be
collected each night for either shipment to the laboratory for
analysis or collection at an approved container/hazardous waste
storage facility.
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Exhibits
Exhibits can include anything that doesn't fit into the documentary
or physical sample description, namely business cards, invoices,
maps of the inspection site, flyers, receipts, etc. Small plastic bags
are useful in collecting and identifying these exhibits and keep the
material from getting lost in the vehicle and/or during other
pesticide investigations/ environmental sampling exercises.
Include photos of the house, yard, etc. in the exhibit section of the
official case file.
The Narrative
Each narrative generated in the field shall include at a minimum the
following information:
* Date of narrative.
*• Date of the inspection.
> Name, address, and phone numbers of the party inspected.
> A full description of the investigation that concisely
summarizes the events/activities.
* The official sample number(s) and a description of the type
of sample, where and how the sample(s) were collected and
if any photographs were taken of the sampled area(s).
> Exhibits including maps, canceled checks, business cards etc.
* Identification of photographs taken of the containers
collected, sampling sites, conditions, treated areas etc.
* List of attachments such as NOI, RFS, statements, sample
collection reports, questionnaires, private/commercial
certification cards, photographs etc.
*• Inspectors' names, credential numbers, and date signed.
Photography
During each emergency situation, attention shall be given to
documenting the alleged violation through photography.
Photographs shall be taken of the sampling sites, containers
collected, dwellings, and alleged applicators/illegal operators. The
team shall take the opportunity to document the overall site
including living conditions and inhabitants.
Film canisters shall be identified by the inspector's name (use tape
wrapped around the role) and placed in a designated area in the
command center. Film shall be developed daily.
Each team shall have access to at least two 35 millimeter cameras in
case one of them becomes inoperative, and four to five roles of 400
speed film.
FRAUD
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The investigation of fraudulent activities in pesticide misuse cases is
difficult at best to prove. Several issues may lead an experienced
pesticides inspector to suspect fraudulent activity. Some of the
telltale signs of fraud are listed below:
> The homeowner does not have specific information as to the
date of the applicators treatment.
> The individual(s) interviewed do not have any business
cards, receipts from the applicator.
> The homeowners/tenants cannot identify the alleged
applicator from the composite lineup.
* The persons interviewed act defensively when questioned
on specific issues related to the alleged pesticide spraying.
* The questions asked by the residents do not reflect a
environmental/human health concern rather a financial and
reimbursement issue.
> The resident directs the inspection team to certain locations
in the home and is adamant that the inspectors sample at
these sites.
*• The analysis of the samples may show an elevated level of
pesticidal compound that is not comparable to other sites
sampled.
*• The spray patterns and areas treated may be different to
those that represent the alleged applicator's standard
operating procedure.
It is imperative that the inspection team closely analyzes all of these
elements and to report these findings to their immediate
supervisory personnel. The Office of Inspector General or the
Federal Bureau of Investigation (FBI) may also be interested in the
information collected during the investigation and will most likely
try to re-interview homeowners if the evidence is strong enough to
implicate fraudulent activity. This decision is not made by the
inspector. As an aside, inspector morale will most definitely be
affected by the implications of fraud and if it goes unchecked will
lead to a significant amount of cynicism in the ranks.
DATABASE
A database should be used to collect all relevant data collected
during the investigation phase. The database can help direct
resources, track the caseload by inspection team and applicator,
prioritize investigations, and give management a tool to determine
assignments and direction of resources to a given site. Elements of
a good emergency pesticide database are listed below:
> Name, address, and phone numbers of inspected party.
*• Number of residents living on-site.
Appendix C • FIFRA High Visibility Incidents • C-19
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Number, names, and ages of children.
Pets.
Inspection date, number, and sequence.
Treatment date.
Applicator(s) (Leave several data sites available for more
than one applicator.
Pesticide distribution (Yes/No).
Residence.
Property owner.
Business (Yes/No).
Type of business (Day care, restaurant, hotel etc.).
Other sites treated.
Residence sampled.
Business sampled.
Lab results.
Action level.
Comments.
VENDORS/CONTRACTS/CHARGE ACCOUNTS
Federal and State pesticide programs shall have a listing of supply,
form, and other contractors available. Vending services shall be
established for the best quality yet affordable sampling supplies,
inspection forms, and safety equipment. Also, local vendors and
contract agreements shall be identified such as local Wai-Marts, K-
Marts, Federal Express, UPS, etc. to facilitate the efficient purchase
of administrative supplies and to develop film collected during the
investigations.
ENFORCEMENT
Dealing with Local Judges, Police, Emergency
Response, Sheriffs Department
As soon as indications are manifested that may require arrest and
search warrants using State authority, contacts should be made with
local law enforcement authorities and prosecutors. These officers
can assist with identifying proper jurisdictions, executing warrants,
providing security when needed, and providing locations to secure
evidence, if necessary. State/local search and arrest warrants issued
pursuant to violations of State/local laws other than pesticide
misuse often provide the avenue to generate much needed pesticide
Appendix C • FIFRA High Visibility Incidents • C-20
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use-related evidence when probable cause otherwise may be
wanting. Properly collected evidence seized during the execution
of legitimate search and arrest warrants also may be used to
document violations of other State or federal laws. This practice
has often been used successfully and emphasizes the partnership of
the State and federal agents and takes advantage of all opportunities
for prosecution.
Civil Proceedings
All violations detected shall be prosecuted and the coordination
between civil and criminal prosecutors shall be encouraged. U.S.
and State attorney's may not want to criminally prosecute all the
cases brought to them. In the interest of justice, dual prosecutions
shall be considered in some cases. However, all cases not
prosecuted criminally shall have administrative actions taken as
soon as possible.
Drafting a Search/Arrest Warrant
This protocol will vary by jurisdictions. Specific examples can be
provided, but local law enforcement will provide the best advice
and direction in this matter. For FIFRA Administrative Warrants,
consult the EPA Inspector's Manual.
Execution of the Arrest/Search Warrant
For FIFRA Administrative Warrants, consult the EPA Pesticide
Inspector's Manual. Work with local law enforcement to execute
State warrants.
The team shall meet prior to the warrant's execution to determine
the roles of all participants. Law enforcement shall effect entry,
secure the premises, and isolate the suspect. The search shall
meticulously cover all areas subject to the search. All items seized
or sampled shall be carefully inventoried and described for the
"return." If appropriate (see the manual and consult the officers),
the suspect shall be Mirandized by a law enforcement officer or by
the arresting officer. A general interview format shall be prepared
prior to execution of the warrant. One agent shall interview and
one shall take careful notes. The role can be reversed for follow-up
questions.
Questions to Ask Applicators
In many cases, when an investigation team conducts an interview
with the actual applicator it is during the execution of an
arrest/search warrant. The applicator shall be advised of his
Miranda rights by a law enforcement officer if he is under arrest. If
the situation presents the opportunity to acquire legitimate
information from an applicator who is agreeable to an interview,
the following questions could be used to illustrate the violative
history of the applicator:
> Full name, address, phone, social security number, and age
of applicator?
*• Certification status?
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Other individuals living at applicators residence and their
occupations?
How is the applicator employed, how long, name of
employer, and phone?
If and when did the applicator begin using pesticides for
hire?
Types of pesticides used?
Where were the chemicals purchased?
Does the applicator use agricultural pesticides such as
methyl parathion in homes?
Where did the applicator conduct his business activities?
Names of clients? Records?
Verbal directions/precautions issued to his clients?
Use of business cards, invoices, and methods of payment?
What method of payment was used to purchase pesticides?
What quantity of product did he purchase?
Did he keep records of his clients, and the amount and
location of the pesticides used/applied?
How much did he charge for his services?
How did he mix the chemical(s)?
Any adverse health affects noted to his person or to his
clients?
How many applications were made per year?
Where are his records kept?
Where are his pesticides stored and how are they stored?
Areas of homes treated, inside/outside and for what pests?
Describe treatment?
What equipment was used to mix and apply the pesticides?
Were businesses treated? Names?
Did he give the pesticide he was using a special name (i.e.,
"Cotton Poison", "Bug Juice")?
How did he promote his service, (newspapers, word of
mouth, other advertisement)?
Does he hold any special positions with local churches,
organizations?
Where did he originally get the idea to utilize methyl
parathion and/or the pesticide under investigation?
Who referred the business and chemical to him for use?
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*• Does he work alone or with another associate?
*• Why did he select the specific compound?
> Does he know of any other applicators or individuals who
sell the chemical from tail gate sales, flea markets, door to
door or make applications to homes, businesses, etc.?
*• Did he sell the pesticide?, cost?, to who? and what type of
containers and dilution rate?
*• Did he apply in other communities, or in other States?
> How was the chemical(s) transported?
> Did anyone purchase the chemical for him? Names?
*• Did anyone transport the chemical(s) to him for use/sale?
*• Other sources of income?
> Where does he dispose of empty containers?
* Does the "source" of the chemical have other customers and
who?
* Does the applicator have a regular physician?
Issuing the Warrants
Judges issue the warrants based on an affidavit signed by a law
enforcement officer. The type of warrant and the jurisdiction will
determine who may sign the affidavit — a law enforcement officer,
a State inspector, or a federal inspector. The warrant shall be as
broad as the court allows and shall be executed in strict accordance
with the terms listed therein. The time for any clarifications shall
be in front of the judge at the time the warrant is signed. Local
officers and prosecutors can be most helpful in selecting judges for
this task. See the Pesticide Inspector's Manual.
Conferring with the Press Before, During and
After the Issuance of the Search/Arrest
Warrants
The press shall not be advised prior to the issuance of a warrant
because an untimely broadcast may lead to the destruction of
evidence or the loss of a suspect by flight. For their safety, and as a
rule, the press shall not be invited to participate in the execution of
the warrant. If the press do show up unexpectedly, they shall be
kept away from the scene by local law enforcement. The media
representative may brief the press after the scene is secure and the
search complete, but only in general terms without revealing
sensitive information. As much as possible, stick to the media
protocol determined at the beginning of the investigation.
Surveillance
Consult the manual. "Ride bys" and static surveillance shall be
carefully planned and shall not be executed without prior approval
of the management team, and proper and careful planning.
Coordination with local law enforcement is advised. Poorly
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executed surveillance may lead to premature awareness on the part
of suspects and the subsequent loss of perhaps critical evidence.
Conducting the Search Both Inside and Outside
the Dwelling
Several pesticide investigators shall be used to conduct the
search/arrest warrant investigation. It is best to have two
inspectors interview the applicator, one to ask the questions and
the other to take notes, and begin to formulate a statement. Also, it
helps to have a second party available during the interview to focus
on missed opportunities and questions asked by the lead
interviewer. A second team should survey the inside of the home
and work from the left side-front of the home move in a concerted
manner sweeping left to the right side of the home searching and
confiscating pertinent documents. A third team can be used to
check the outside of the home to collect any pesticide containers
and document any disposal sites on the property.
The team assigned to the inside of the dwelling shall take every
opportunity to discover records, diaries, notes, business cards, etc.
in the home. Night stands, bedrooms, offices, the kitchen table,
and where telephones are located are especially productive when
conducting search and seizure activities. The team shall take its
time when searching the premises and shall check periodically with
the interviewing team to ascertain if the applicator has divulged any
areas of record storage in the dwelling. Many individuals will have
a wall mount calendar that they use to record transactions and
phone numbers of customers and will use the blank portion of the
local phone book to transcribe customer phone numbers.
Outbuildings adjacent to the primary dwelling shall be thoroughly
searched for pesticides and equipment. A shed may be located at
the edge of the property that may include mixing equipment and
the suspected chemicals. Care shall be taken to properly collect the
material/containers, depict the location of collection on a map
made by the inspection team and provide an accurate/descriptive
listing of all inventory collected for use on the search warrant
manifest.
Media/Press
The press can be utilized very effectively to educate and prepare the
communities involved in the exercise for the inspection teams visit.
A good working relationship with the press should be fostered and
certain members of the task force shall be designated to handle
technical questions and press interviews. Public affairs offices,
both at the federal and State level will also provide assistance with
the press.
As with all major new stories, the press may take a keen interest in
the daily operations of the investigations and any new information
that can air on the 5 o'clock news or in the next days newspaper
headlines. The team may be asked for names of persons/sites
inspected. The team shall not, under any circumstances, divulge
the identity of any individual they have inspected. This information
must be kept confidential. If the team is directed to allow the
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presence of the press at one or more of the inspections, the team
shall contact the resident and get their permission before the team
allows the press to tag along. The team shall not provide the name
of that individual to the press. Allow the resident to provide this
information to the press upon their arrival at the site. Some
residents may consent to the press paying a visit on the phone only
to deny them access once they have arrived with the inspection
team. Also, do not allow the press to enter the structure while the
inspection team is present at the site. The Notice of Inspection
(consent) only allows the entry of authorized State and federal
personnel. The invitation does not extend to any other entity
outside that arena. With the tenants/homeowners consent, the
press may enter their home after the team has completed their
inspection and left the premises.
Acquiring Video Coverage from News
Broadcasters
If the press is actively covering the emergency situation, the
leadership team may elect to contact a local dubbing service, all of
the local news broadcasting stations, and newspaper services to try
to acquire footage of the proceedings, inspection team interviews,
press briefings, etc. for late training purposes and to document the
event. Dubbing services usually charge anywhere from $25.00 to
$75.00 per episode and then discount each segment thereafter
depending on the amount of broadcasts ordered. Some news
stations, depending on their relationship with the agency will
reproduce copies of the segments for a minimal cost or free of
charge if a videocassette is provided. The management team may
elect to have the inspectors and their family tape the news casts
from their personal video equipment and then collect all the
footage after the event is over. Public affairs offices shall be used
to help initiate contact with the press and to acquire footage as well.
Appendix C • FIFRA High Visibility Incidents • C-25
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APPENDIX D
FIFRA MEDIA
INTERACTION
MEDIA INTERACTION
The press can be utilized very effectively to educate the public
regarding the laws and regulations governing the use, sale, and
distribution of pesticides. A good working relationship with the
press should be fostered, and designated staff members should
handle both technical questions and interviews with members of
the press.
When called upon for interviews, first ask when and where the
interview will occur. (Note: Always contact a supervisor before
committing to an interview). To adequately prepare for the
interview, find out in what type of surroundings the interview will
be conducted. Find out if the interview will be taped or if it will be
a live interview. If the interview is taped, there will be time to
stop/pause and think of good, logical answers to questions.
However, if the interview is live, there will not be as much time to
think. Advanced preparation is critical.
When answering questions, be sure to answer only one question at
a time. It is not uncommon for a reporter to ask a "two-part"
question. When this occurs, take time and address each point
individually. This allows for complete, concise answers to
questions.
Communicate with the reporter as if everything will appear on the
five o'clock news or the front page of the newspaper. With this
point in mind, never ask a reporter to keep something "off the
record." There are no guarantees that the reporter will grant that
request. Speak as if everything that is said will appear in print.
Interviewees must always remember to think before he/she
speaks, and to do his/her homework. This is crucial!
Ask the reporter to repeat a question if it is unclear what is being
asked, and provide the reporter with any fact sheets, literature, or
other materials that may help provide a clearer understanding of the
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subject. The interviewee may choose not to answer a question if
he/she is not qualified to do so; however, the interviewee should
tell the reporter that he/she is not qualified to answer the question.
Finally, quickly correct any inaccurate statements so as not to
convey the wrong message. The interviewee should not let the
interviewer put false statements in his/her mouth.
As with all news stories, the press may take a keen interest in the
daily operations of the Agency's investigations, and other "news-
worthy" information about pesticides. Questions may arise
regarding the identity of inspected parties, facts discovered, and
possible enforcement actions of an ongoing investigation. This
information is to be kept confidential until the investigation is
complete. If critical information is divulged, the whole investigation
may be jeopardized. Never release any information that may be
considered to be enforcement sensitive.
After the interview is completed, it may be possible to obtain a
copy of the interview for the inspection files or for training
purposes. Dubbing services are available for this type of service,
and they usually charge between $25.00 and $75.00 per episode,
then discount each segment thereafter depending upon the amount
of material ordered. Some news stations, depending on their
relationship with the agencies involved, may be willing to reproduce
this information free of charge. This information can be very
useful for training staff on working with the media.
Working with the media can be a difficult process if there is a lack
of preparation on the part of the interviewee. However, if the
information provided above is considered, and if the interviewee
does his/her homework, the interview will be a good learning
experience. During an interview, try to maintain a positive attitude
and make positive points; this will help instill confidence and keep
the interview moving in a positive direction.
Appendix D • FIFRA Media Interaction • D-2
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APPENDIX E
FIFRA GENETICALLY
MODIFIED PLANT
PESTICIDES
BACKGROUND
Recent advances in biological science allow the introduction of
genetic material into plants to cause those plants to produce
pesticidal substances. EPA has determined that genetically induced
plant pesticides warrant regulatory oversight since there is a
potential for novel dietary and environmental exposure of the
pesticidal substances.
On November 23, 1994, (59 FR 60495) EPA published a statement
of proposed policy and proposed rulemaking clarifying the status of
plant pesticides. In this statement EPA indicated its intent to
regulate plant pesticides other than those determined to be of low
potential for risk, and proposed a regulatory framework, including
definitions and proposed exemptions. EPA described in the
proposed rule that it considers a plant pesticide to consist of a
combination of both the pesticidal substance and the genetic
material that induces its production in the plant. As of August,
2000, the final rule was anticipated to be published late in calendar
year 2000. When final, the rule will be available on the OPP web
site.
PLANT PESTICIDE REGULATION
EPA issued its first plant pesticide experimental use permit (EUP)
in 1994 and its first registration in 1995. Since 1995 a limited
number of registrations have been issued. As of year 2000 the
majority of registrations have been for Bacillus thuriengensis (B.t.)
in crops.
EPA has determined to place its regulatory oversight of plant
pesticides prior to seed distribution, with the intention of
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preventing potentially harmful genetic traits from entering the
channels of trade. Close regulation occurs prior to registration.
Conditions of experimental use permits, including permits that may
allow increase in seed stock, control the distribution and use of
experimental seed material. Experimental plant pesticide material is
subject to FIFRA in the same manner as experimental chemicals,
including record-keeping and production establishment production
requirements.
When a registration is issued, it identifies the registered pesticide
product as what is applied to the seed stock by the registrant at an
early stage of crop seed production. The 'treated' seed is considered
exempt from further FIFRA regulation as long as its use complies
with the treated article exemption at 40 CFR 152.25(a). This means
that subsequent seed production does not have to comply with
requirements such as FIFRA sections 7 and 8. The seed that is
sold does not have to be labeled as a pesticide, and the use of
transgenic seed by farmers is not controlled by FIFRA.
Seed production and distribution which is exempted FIFRA may
be reportable on a case-by-case basis by registrants as conditions of
registration. The Office of Pesticides Programs, Biopesticides and
Pollution Prevention Division may be contacted to obtain
information regarding whether sales and use data are available for
specific plant pesticides.
POTENTIALLY VIOLATIVE PLANT PESTICIDE ACTIVITIES
Since proper use of registered plant pesticides exempts products in
commerce and use from FIFRA regulatory oversight, potential
violations are generally likely only with respect to unregistered plant
pesticides, including plant pesticides that are at pre-registration
(e.g., experimental use permit) stages. The distribution or sale of
unregistered plant pesticides is potentially violative under FIFRA
section 12(a)(l)(A). The use of a plant pesticide under an
experimental use permit in a manner contrary to the provisions of
the permit is violative under section 12(a)(2)(H).
Plant pesticides may, as may any pesticide, be exempted by rule or
by statute from FIFRA regulatory coverage. General exemptions
(e.g., at 40 CFR 152.25 and 152.30) may apply to plant pesticides.
Specific plant pesticides or categories of plant pesticides may be
exempted by rulemaking. Statutory exemptions under FIFRA
section 17, which apply to pesticides intended solely for export,
also apply to plant pesticides intended solely for export.
Plant pesticides that are registered, or are under an experimental
use permit, or that are unregistered but transferred under an
exemption that allows transfer but does not categorically exempt
the product from FIFRA oversight (e.g., exemptions at 40 CFR
152.30 and FIFRA section 17(a)), are subject to section 7 reporting
and section 8 record-keeping, and if noncompliant are potentially
violative under FIFRA sections 12(a)(2)(B) and (L). In the case of
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registered pesticides, however, these requirements may apply to
very limited circumstances, since seed treated with registered
product are not subject to FIFRA.
COMPLIANCE MONITORING
Compliant product in the channels of trade is exempt from FIFRA
and hence not subject to routine compliance monitoring. Tips or
complaints will be the chief means for identifying product which is
potentially not compliant and therefore subject to FIFRA. The
linkage between section 3 registration compliance and FIFRA
applicability requires that headquarters (OPP and OECA) be
consulted on all investigations.
RESPONSES TO VIOLATIONS
Distribution or use of unregistered transgenic seed may trigger
actionable violations under sections 12(a)(l)(A) or 12(a)(2)(H). The
shipment may be subject to SSURO or seizure under section 13,
and civil or criminal penalties as appropriate under section 14.
Appendix E • FIFRA Genetically Modified Plant Pesticides • E-3
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APPENDIX F
FIFRA INSPECTOR
CREDENTIALS
NOTE: This Appendix will be sent under a separate
cover when finalized.
Appendix F • FIFRA Inspector Credentials • F-1
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APPENDIX G
SMALL BUSINESS
REGULATORY
ENFORCEMENT AND
FAIRNESS ACT
(SBREFA)
POLICY
The following memorandum from Eric Shaeffer
disseminates information regarding small business. Also
included is an information sheet which shall be handed
out by the inspector at each location where a FIFRA
inspection is conducted provided that the facility meets the
criteria as explained in the memorandum.
MEMORANDUM
SUBJECT: Final Guidance on Disseminating EPA's SBREFA Information Sheet to
Businesses at the Time of an Enforcement Activity
FROM: Eric V. Schaeffer, Director
Office of Regulatory Enforcement
TO: Regional Counsel, Regions I-X
Enforcement Coordinators, Regions I-X
Headquarters and Regional Enforcement Division Directors Headquarters
and Regional SBREFA Contacts OGC SBREFA Contact
This memorandum replaces the December 23,1998 guidance and is in response to Regional
questions on the Small Business Regulatory Enforcement and Fairness Act (SBREFA)
information sheet (attached), which EPA has agreed to disseminate to small businesses
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beginning on April 1,1999. The information sheet itself has also been revised to reflect Regional
comments. As mentioned in the December 1998 guidance, EPA agreed that it would notify
small businesses of their right to comment on regulatory enforcement activities at the time of an
Agency enforcement activity pursuant to SBREFA Section 222 in response to Small Business
Administration1 (SBA) and Congressional requests.2
The information sheet is intended to inform small businesses of their rights to comment to the
SBREFA Ombudsman about EPA enforcement activity, as well as provide information on
compliance assistance. As you will see from the attached, we tried to draft this language to
remind the reader that SBREFA does not eliminate the responsibility to respond to a complaint,
information request, or other enforcement activity within the time allowed nor does it create
any new rights or defenses under law. The information sheet should be given to a small
business at the time EPA has its initial enforcement contact with the business, which we have
determined may include the following activities:
•Inspection
•Warning letter
•Reminder notice or letter
•Compliance Audit Program or Incentive letter or notice
•Information collection request
•Subpoena
•Show cause letter
•Administrative search or other warrant
•Stop sale, use, and removal order (SSURO)
•Notice of Violation or other notice letter
•Administrative complaint Administrative order or administrative penalty order.
In general, it should only be necessary to distribute the information sheet once, at the time of
the first formal enforcement contact. If appropriate, the information sheet may, in addition to
the initial hand-out, be disseminated at later junctures in an enforcement activity at the Region's
discretion. The SBA generally defines a small business as 500 employees or less although a
business with as many as 1500 employees and up to $23 million dollars in annual receipts may
qualify as a small business depending on the SIC code involved (SBA's small business
definitions are codified at 13 C.F.R. 121.201). If there is any question whether a business is small,
the information sheet should be given to that business.
1 SBA's SBREFA Ombudsman is charged with administering § 222 of SBREFA. Section 222, entitled
"Oversight of Regulatory Enforcement" contains the SBREFA provision allowing small businesses to comment on
agency enforcement activities, which may include audits, on-site inspections, compliance assistance efforts or other
enforcement-related communication or contact by an agency.
SBREFA's legislative history provides that the "SBA shall publicize the existence of the Ombudsman
generally to the small business community and also work cooperatively with enforcement agencies to make small
business aware of the program at the time of agency enforcement activity ." Joint Statement of Senators Bond and
Bumpers, March 29, 1996, Cong. Rec. S3242 (pp. S3242). To carry out this legislative intent, the SBA Ombudsman
requested agencies to disseminate information about SBREFA to small businesses. SBA's small business definitions
are codified at 13 C.F.R. 121.201.
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FIFRA Inspection Manual, February 2002
In response to the questions raised by your offices, we have made changes to this Guidance and
to the Information Sheet, as summarized below.
Q: Should the information sheet be given out in criminal investigations or actions?
A: No. The information sheet should not be given out in criminal investigations
or actions for several reasons. First, SBREFA is geared towards, and appears only
to apply to, civil or administrative actions. Second, the leading role of Assistant
United States Attorneys (or DOJ Trial Attorneys) in criminal investigations and
prosecutions makes it inappropriate for EPA to unilaterally agree to provide Reg
Fair Notice in criminal investigations. Third, no other agency appears to be
disseminating the sheet in criminal actions, including EPA's counterparts
involved in environmental criminal investigations. Fourth, EPA is generally not
able to disclose any information about criminal investigations or actions.
Q: Should the information sheet be given out in CERCLA (or Superfund), RCRA
corrective or Oil Pollution Act actions?
A: This guidance does not address activities under the Comprehensive
Environmental Response Compensation and Liability Act ("CERCLA"), the
provisions of the Resource Conservation and Recovery Act ("RCRA") concerning
corrective action and remediation of underground storage tanks, and the
provisions of the Oil Pollution Act and Clean Water Act section 311 concerning
remediation of oil and hazardous substance spills. Guidance will be forthcoming
from the Office of Site Remediation Enforcement to clarify the application of the
SBREFA information sheet dissemination requirements to enforcement of
CERCLA and the other remediation statutes. This guidance will be issued by
May 15,1999.
Q: Should the sheet be handed out after a matter has been referred to the Department of
Justice?
A: No. In the unlikely event that the initial enforcement contact with a small
business occurs after the matter has been referred, DOJ is responsible for
determining whether the SBREFA information sheet will be handed out. As with
all matters referred to DOJ, EPA employees should coordinate with DOJ before
having any communication with current or potential defendants or with other
outside individuals or agencies. As such, the December 23rd guidance
suggesting that, a civil judicial action is one of the junctures at which the
information sheet should be handed out is corrected to read only
"Administrative complaint."
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FIFRA Inspection Manual, February 2002
Q: What type of training should we be giving staff?
A: The "training" we anticipated was informal discussion at staff and other
meetings sufficient to ensure that the employees that would be handing the sheet
out were aware of the requirement and knew who to contact if questions arose
(the Regional SBREFA contact or Carolyn Dick at 202-564-4007).
Q: Should we be tracking or counting the number of information sheets handed out?
A: We suggest that you make a note to the file confirming that the information
sheet was given to the business and, until further notice, track and count the
number of sheets handed out.
Q: Should contractors responsible for inspections (or for any other activity when the
sheet should be handed out) be required to hand out the information sheet?
A: Yes, if a contractor, doing the work of the EPA, is the first representative to
come in contact with a small business at one of the above-listed junctures, then
the contractor should hand the information sheet out to small businesses.
Q: Can the information sheet be revised to include regional-specific information and
must those revisions be reviewed by SBREFA staff at Headquarters?
A: This sheet must be distributed verbatim to avoid confusion that could arise
from paraphrasing, particularly in light of the concern that we be nationally
consistent in informing small businesses of the resources and rights available to
them. If a Region would like to add regional-specific information, the Region
should draft a cover memorandum including that information and forward it to
the Office of Regulatory Enforcement for approval to ensure a nationally
consistent and accurate message. Any such memoranda can be sent via the LAN
or mail to Carolyn Dick (mail code 2246A).
Please begin disseminating the attached information sheet to small businesses at the time of
initial enforcement contact during the activities listed above, on April 1,1999. Since EPA must
inform SBA that the information sheet is being disseminated, I am requesting each Regional
Enforcement Coordinator to inform me by April 5,1999, that their Region has begun
implementing this Guidance.
If you have any comments or questions, please call me or have your staff contact Carolyn Dick
(telephone 202-564-4007). Thank you for your help in complying with SBA 's request.
Appendix G • SBREFA • G-4
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FIFRA Inspection Manual, February 2002
Information for Small Businesses
If you are small business as defined by the Small Business Administration (defined at 13 CFR
121.201; in most cases, this means a business with 500 or fewer employees), below is
information you may find helpful.
The United States Environmental Protection Agency (EPA) offers small businesses a wide
variety of compliance assistance resources and tools designed to assist businesses to comply
with federal and State environmental laws. These resources can help businesses understand
their obligations, improve compliance and find cost-effective ways to comply through the use of
pollution prevention and other innovative technologies.
Websites
Hotlines
EPA offers a great deal of compliance assistance information and
materials for small businesses on the following Websites, available
through public libraries:
• •www.epa.gov
• •www.smallbiz-enviroweb/org
• *www. smallbiz-envir o web. or g/state.html
• *www.epa.gov/ttn/sbap
• •www.epa.gov/oeca/polguid/index.html
• •www.epa.gov/oeca/smbusi.html
• •www.epa.gov/oeca/oc
• •www.epa.gov/oeca/ccsmd/commpull.html
• •www.epa.gov/oeca/ccsmd/mun.html
EPA 's Home Page
EPA 's Small Business
Home Page
List of State Contacts
Small Business
Assistance Programs
Enforcement Policy and
Guidance
Small Business Policy
Compliance Assistance
Home Page
Small Businesses and
Commercial Services
Small Communities
Policy
EPA sponsors approximately 89 hotlines and clearinghouses that provide
free and convenient avenues to obtain assistance with environmental
requirements. EPA's Small Business Ombudsman Hotline can provide
you with a list of all the hot lines, and assist you with determining which
hotline will best meet your needs. Key hotlines that may be of interest to
you include:
Small Business Ombudsman ..................................... (800) 368-5888
«RCRA/UST/CERCLA Hotline ............................................ (800) 424-9346
*Toxics Substances and Asbestos Information .................... (202) 554-1404
"Safe Drinking Water [[[ (800) 426-4791
"Stratospheric Ozone/CFC Information .............................. (800) 296-1996
^Clean Air Technical Center [[[ (919) 541-0800
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FIFRA Inspection Manual, February 2002
Compliance
Assistance Centers
State Agencies
EPA has established national compliance assistance centers, in
partnership with industry, academic institutions, and other federal and
State agencies, that provide on line and fax back assistance services in the
following sectors heavily populated with small businesses:
• 'Access to All Centers (www.epa.gov/oeca/mfcac.html)
• Metal Finishing (1-800-AT-NMFRC or http://www.nmfrc.org)
• "Printing (1-888-USPNEAC or http://www.pneac.org)
• •Automotive (1-888-GRN-LINK or http://www.ccar-greenlink.org)
• •Agriculture (1-888-633-2155 or http://www.epa.gov/oeca/ag)
• "Printed Wiring Board Manufacturing (http://www.pwbrc.org)
• *The Chemical Industry (1-800-672-6048 or
http://www.chemalliance.org)
• *The Transportation Industry (http://www.transource.org)
• *The Paints and Coatings Center (http://www.paintcenter.org)
• "Local Governments (1-877-TO-LGEAN or http://www.lgean.org)
Many State agencies have established compliance assistance programs
that provide on-site as well as other types of assistance. Please contact
your local State environmental agency for more information. EPA's Small
Business Ombudsman can provide you with State Agency contacts by
calling (800)-368-5888.
Compliance
IncentivePolicies
EPA's Small Business Policy and Small Communities Policy are intended
to promote environmental compliance among small businesses by
providing incentives such as penalty waivers and reductions for
participation in compliance assistance programs, and encouraging
voluntary disclosure and prompt correction of violations. These policies
can not be applied to an enforcement action that has already been
initiated. Contact Ginger Gotliffe (202-564-2310) for information on the
Small Business Policy and Ken Harmon (202-564-2310) for information on
the Small Communities Policy.
In order to improve your understanding of and compliance with environmental regulations and
avoid the need for future enforcement actions, we encourage you to take advantage of these
tools. However, please note that any decision to seek compliance assistance at this time does
not relieve you of your obligation to respond to an EPA request, administrative or civil
complaint in a timely manner, does not create any new rights or defenses, and will not affect
EPA's decision to pursue this enforcement action.
The Small Business and Agriculture Regulatory Enforcement Ombudsman and ten Regional
Fairness Boards were established to receive comments from small businesses about federal
agency enforcement actions. The Ombudsman will annually rate each agency's responsiveness
to small businesses. If you believe that you fall within the Small Business Administration's
definition of a small business (based on your SIC designation, number of employees or annual
receipts, defined at 13 C.F.R. 121.201) and wish to comment on federal enforcement and
compliance activities, call 1-888-REG-FAIR (1-888-734-3247).
Appendix G • SBREFA • G-6
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FIFRA Inspection Manual, February 2002
However, participation in this program does not relieve you of your obligation to respond to an
EPA request, administrative or civil complaint or other enforcement action in a timely manner
nor create any new rights or defenses under law. In order to preserve your legal rights, you must
comply with all rules governing the administrative enforcement process. The ombudsman and
fairness boards do not participate in the resolution of EPA's enforcement action.
Dissemination of this information sheet does not constitute an admission or determination by
EPA that your business, organization or governmental jurisdiction is a small entity as defined
by the Small Business Regulatory Enforcement and Fairness Act (SBREFA) or related provisions
nor does it create any new rights or defenses under law.
Appendix G • SBREFA • G-7
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APPENDIX H
SAFETY AND HEALTH
REQUIREMENTS FOR
EPA COMPLIANCE
INSPECTORS FACT
SHEET
MAY 14, 2001
MEMORANDUM
SUBJECT: Revised Fact Sheet: Safety and Health Requirements for EPA Compliance
Inspectors
FROM: Michael Alushin, Director '
Compliance Assessment and Media Programs Division
TO: Regional Enforcement Division Directors, Regions 1, 2,4, 6, 8
Regional Media Division Directors, Regions 3, 5, 7,9, 10
Regional Science and Technology Division Directors, Regions 1-10
This memorandum transmits a revised fact sheet to distribute to the regional inspectors in your
respective organizations. We prepared the fact sheet in response to requests for a quick
reference summary made at the National Inspector Workshop we held last November. If you
wish more information, you should obtain copies of EPA Orders 1440.1, 1440.2, 3500.1, and the
OSHA requirements in 29 CFR 1910.120. The fact sheet discusses how to obtain copies of these
documents.
This revised fact sheet was developed to address concerns expressed by Regional safety and
health officers dealing with refresher health and safety training. The following highlights
considerations leading to the revisions we made to the fact sheet:
Appendix H • Safety and Health Requirements for EPA Compliance Inspectors Fact Sheet • H-1
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FIFRA Inspection Manual, February 2002
• Language in the various safety and health orders can be interpreted in several ways.
• After reviewing Regional concerns, we have decided to revise the fact sheet to interpret
the Orders as requiring only a minimum of eight hours annual refresher training.
• EPA inspectors that have been trained to the intermediate or advanced level need
different refresher training than inspectors trained to the basic level.
We encourage the Regions, based on the number of intermediate and advanced level inspectors
in their Region, to provide training on the specific risks posed to these inspectors. The Regions
should be providing safety and health refresher course specifically for the level the inspector
has achieved (basic, intermediate or advanced). The basic level refresher course can generally
be met by reviewing the "Safety, Health and Environmental Management Training for Field
Activities", in conjunction with the field refresher requirement. We encourage you to review
the various EPA Orders dealing with safety and health of EPA employees that are posted on the
EPA Inspector Website. The website address is:
http://INTRANET.EPA.GOV/OECA/OC/METD/INSPECTOR
Thank you for your attention. We sincerely hope the revised fact sheet will improve the
understanding of the health and safety requirements in order to provide EPA inspectors with a
safe and healthy working environment. If you have any questions about this fact sheet, you can
contact either OECA (Ken Gigliello at 202-564-2300) or OARM (Jerry Oakley at 202-564-2082).
cc: OC Division Directors
ORE Division Directors
OCEFT Division Directors
OARM/Safety, Health and Management Division
Enforcement Coordinators, Regions I-X
Safety and Health Officers, Regions I-X
Appendix H • Safety and Health Requirements for EPA Compliance Inspectors Fact Sheet • H-2
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FIFRA Inspection Manual, February 2002
REVISED FACT SHEET
Safety and Health Requirements for EPA Compliance Inspectors
(May 11, 2001)
Introduction This fact sheet is intended to be a quick reference guide for EPA compliance
inspectors. It provides a summary of the requirements of EPA Orders 1440.1 and
1440.2, and OSHA 29 CFR 1910.120 (e)(3)-(9). EPA compliance inspectors should
obtain copies of the specific Orders and the OSHA regulations for more specific
information. EPA Orders dealing with safety and health are posted on the EPA
Inspector Website. The website address is:
http://INTRANET.EPA.GOV/OECA/OC/METD/INSPECTOR
Background EPA Order 1440.1, dated May, 1998, Safety, Health and Environmental
Management Program, establishes new policies, delegates authorities, defines
management functions and responsibilities, and creates Agency-wide
organizational structure for the administration of Safety, Health and
Environmental Management (SHEMP). Copies of the Order can be obtained
from the Office of Administration and Resource Management (OARM), Safety,
Health and Environmental Management Division (Phone: 202-564-1640), or the
Regional Safety and Health Officer.
EPA Order 1440.1 is an omnibus Order designed to replace all specific EPA
Orders dealing with safety, health and environmental management. This action
was taken to minimize the number of orders and to enable more flexibility in
modifying regulations through the use of guidelines.
When EPA Order 1440.1 was finalized, the OARM was beginning a review of the
entire issue of training requirements for both field and laboratory employees.
Until this review was completed, OARM did not want to make changes to the
Orders related to training.
As a result, EPA Order 1440.2, Health and Safety Requirements for Employees
Engaged in Field Activities, was not incorporated into EPA Order 1440.1.
However, OARM expects to do so in the Spring of 2001. OARM is examining
several alternatives and when the review is completed, they will produce a set of
guidelines to be included under EPA Order 1440.1. This will eliminate EPA
Order 1440.2. Until that time, EPA Order 1440.2 remains in effect.
The guidelines that have been, and will be developed to replace existing Orders
will be issued to EPA personnel to explain statutory and regulatory mandates, to
interpret their application to EPA activities, and to identify the knowledge, skills,
and abilities of personnel who must implement them. The guidelines are
recommendations, and do not have to be followed exactly.
Appendix H • Safety and Health Requirements for EPA Compliance Inspectors Fact Sheet • H-3
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FIFRA Inspection Manual, February 2002
Guidelines Approximately 55 safety, health and environmental management guidelines
have been developed to date to help EPA manage its safety, health and
environmental management responsibilities. The guidelines developed to date
covering a wide range of topics including management systems, environmental
statutes, transferring real property, office building compliance, fire protection
and life safety, chemical handling and safety, laboratory procedures, forklift
operations, electrical safety, radiation, lockout/tagout, occupational noise,
workplace hazards, hazard communication, handling of PCB's and asbestos, and
personal protective equipment.
EPA Order
1440.2
EPA Order 1440.2, dated July 12,1981, and titled Health and Safety
Requirements for Employees Engaged in Field Activities, establishes policy,
responsibilities, and mandatory requirements for occupational health and safety
training and certification, and occupational medical monitoring of Agency
employees engaged in field activities. The Order is seven (7) pages in length.
The Order establishes three (3) levels of initial health and safety training: basic
(24 hours), intermediate (8 hours), and advanced (8 hours). The specific
requirements for each level are listed below. This Order is incorporated by
reference into EPA Order 3500.1, Training and Development for Lead
Compliance Inspectors/Field Investigators, dated June 29,1988. This Order is
currently being revised but the EPA Order 1440.1 reference will be included in
the revised Order.
The Order only reflects EPA's internal training requirements and does NOT
eliminate the requirements for field personnel working with hazardous materials
covered by 29CFR 1910.120 (e)(3)-(9). These OSHA regulations require training
for employees working at clean-up operations conducted under the Superfund or
RCRA correction action programs, voluntary cleanup operations, operations
involving hazardous waste at RCRA Treatment, Storage and Disposal Facilities
(TSDF's), and emergency response operations for releases of hazardous
substances. The requirements can be retrieved from the OSHA web site at
http://www.osha-slc.gov/OshStd data/1910 0120.html. While many of these
requirements are similar and some training will count toward meeting both sets
of requirements, it should be remembered that they are separate requirements.
Basic
The basic level training shall include, but not be limited to, classroom instruction
in all of the following areas:
• • Employee rights and responsibilities
Appendix H • Safety and Health Requirements for EPA Compliance Inspectors Fact Sheet • H-4
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FIFRA Inspection Manual, February 2002
• • Nature of anticipated hazards
• • Emergency self-help and rescue
• • Vehicles - mandatory rules and regulations
• • Safe use of field equipment
• • Use, handling, storage, and transportation of hazardous material
• • Personal protective equipment and clothing, use, and care, and
• • Safe sampling techniques
In addition to classroom instruction, the employee shall accompany an employee
experienced in field activities and perform actual field activities for a minimum
of three (3) days within a period of three months after classroom instruction.
Intermediate The intermediate level training is required for employees who engage in
activities at uncontrolled hazardous waste and hazardous spill site investigations
or employees engaged in other activities are determined at a later date to present
unique hazards requiring additional training. The intermediate training shall
include, but not be limited to, to the following subject areas:
• • Site surveillance, observation, and safety plan development
• • Use and decontamination of totally enclosed protective
clothing/equipment
• • Use of field test equipment for radioactivity, explosivity, and other
measurements
• • Topics specific to other identified activities
In addition to classroom instruction, the employee shall accompany an employee
experienced in hazardous waste and spill site investigations and/or cleanup
operations and perform actual field activities for a minimum of three (3) days
within a period of three months after classroom instruction.
Advanced The advanced level training is required for employees who manage uncontrolled
hazardous waste and spill site monitoring, sampling, investigations and cleanup
operations. The advanced training shall include, but not be limited to, to the
following subject areas:
• • Management of restricted and safe zones
• • Rules of handling the press and VIP's
• • Safe use of specialized sampling equipment
Appendix H • Safety and Health Requirements for EPA Compliance Inspectors Fact Sheet • H-5
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FIFRA Inspection Manual, February 2002
In addition to classroom instruction, the employee shall accompany an employee
experienced in managing hazardous waste and spill site investigations or
cleanup operations and perform actual field activities for a minimum of three (3)
days within a period of three months after classroom instruction.
Refresher Refresher training requirements are a minimum of eight (8) hours for all EPA
inspectors. The type of training required depends upon which level of training
the EPA inspector has completed. Basic level refresher training is probably
appropriate for most EPA inspectors.
For EPA inspectors that have taken intermediate and advanced level safety and
health training, refresher training should be tailored to the specific needs of the
particular EPA inspectors, where possible. The Regions and/or OARM are
responsible for developing and delivering this level-specific refresher training.
In addition to the classroom instruction, employees shall have demonstrated
sufficient practical experience to perform their duties in a safe and healthful
manner by having performed actual field tasks related to their level of training.
Appendix H • Safety and Health Requirements for EPA Compliance Inspectors Fact Sheet • H-6
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FIFRA Inspection Manual, February 2002
Safety and Health Training Availability
Training
How to Get?
Where
Delivered?
Comments
EPA Safety
and Health
Environ-
mental
Management
Training for
Field
Activities -
computer
based CD-
ROM course
Jerry Oakley
(OARM)
202-564-2082
Includes modules on employee rights and responsibilities,
nature of anticipated hazards (in-depth), personal
protective equipment, some safe use of field and sampling
equipment, and transportation of hazardous materials. CD
does not cover emergency self-help and rescue, mandatory
rules and regulations for vehicles, and specific field and
sampling equipment procedures.
This CD was not available when EPA Order 1440.2 was
written in 1981. OARM has approved CD-rom training as
an acceptable alternative to traditional classroom training
with a couple of caveats: 1) Some activities (e.g., respirator
fit testing) require hands-on training, and are not covered
by CD-rom training, 2) the one requirement that all
technology-based training to be acceptable to EPA and
OSHA is that the user have access, either on-site or by
other means of communication, to a source of information
to answer any specific questions that may occur during the
technology-based training. Generally this is the
supervisor, the local health and safety program manager,
or an experienced employee.
Under the existing CD-rom course (SHEMD Disk #2),
OARM allows one hour of training credit per training
module. The CD-rom includes 34 modules. Students are
required to take a total of 24 modules to meet the health
and safety requirements. Eighteen (18) specific modules
are required to be taken. The student must then choose six
(6) additional modules from the remaining 16 modules that
address the type of work they routinely conduct.
The SHEMD disk #2 only covers the basic EPA 24-hour
course. Some of the modules can be used as part of the
annual 8-hour refresher program.
Appendix H • Safety and Health Requirements for EPA Compliance Inspectors Fact Sheet • H-7
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FIFRA Inspection Manual, February 2002
Health and
Safety
Training Live
Course
Limited
availability in
Edison, NJ,
Cinncinnati,
OH and
selected
Regions.
This course is a full 40-hour course that covers employee
rights and responsibilities, nature of anticipated hazards
(in-depth), personal protective equipment, some safe use of
field and sampling equipment, and transportation of
hazardous materials. This course also covers emergency
self-help and rescue, mandatory rules and regulations for
vehicles, and specific field and sampling equipment
procedures.
First aid and
CPR courses
American Red
Cross and
other
commercial
vendors
These two courses can be combined in a one day event or
taken separately. First aid courses offered by the Red
Cross only need to be taken every 3 years. CPR courses are
required every year.
Vehicle rules
and
regulations
Regional
Health and
Safety
Training
Officer. GSA
or commercial
vendors offer
a defensive
driving course.
Since EPA inspectors spend a considerable amount of time
driving to conduct inspections, it is required that they
know what to do in case of an accident or other mishap.
In addition, since driving is a hazard of the job, inspectors
should, on some routine basis, take a defensive driving
course to hone and sharpen their skills.
Shipment of
Hazardous
Materials
OARM
distributed a
DOT course
on CD-rom to
the Regions.
Courses are
commercially
available.
All inspectors who ship hazardous materials should take
the DOT or commercially available course.
Contact the Regional Safety and Health Program manager
for details.
OC recently transmitted a fact sheet for inspectors on DOT
training requirements for shipping hazardous materials.
Other
courses
OARM
OARM can be contacted for additional CD-rom and web-
based courses to supplement field personnel training on
topics such as radiation protection, due diligence-real
property transfers, and OECA compliance training
manuals.
Appendix H • Safety and Health Requirements for EPA Compliance Inspectors Fact Sheet • H-8
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APPENDIX I
ELECTRONIC
RECORDS
BACKGROUND
The inspector may encounter electronic records when conducting
various FIFRA inspections. Electronic records are different than
actual paper records in that they are stored electronically in a
computer, data system, etc.
Customarily the inspector views and obtains, if necessary, copies of
paper records, such as: invoices, bills of lading, pesticide use
records, sales/distribution records, and etc. During the inspection,
in the event the inspector encounters electronic records, the
inspector has the authority to request that the owner, agent, or
person in charge provide to the inspector printed copies of any
electronic record that the inspector may require to fulfill the scope
of the particular inspection which is being conducted.
Appendix I • Electronic Records • 1-1
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