PESTICIDES INSPECTION MANUAL
Prepared for the
U.S. Environmental Protection Agency
Office of Compliance Monitoring
Compliance Branch
401 M Street, S.W.
Washington, D.C. 20420
Prepared by
SRA Technologies, Inc.
4700 King Street
Alexandria, VA 22302
Contract No. EPA 68-01-7379-21
-------
FOREWORD
The primary purpose of this Manual is to assist Federal inspectors who are involved in pesticides
enforcement and may also be useful in orienting and training State 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. The 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 the EPA in protecting human health and
the environment from unsafe and ineffective pesticides by enforcing the pesticide laws. A vigorous 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 (1) conduct inspections and
investigations that discover violations of the laws and regulations and (2) collect the evidence necessary
to prosecute violators successfully.
All changes, revisions, additions, or deletions will be forwarded through a Pesticides Inspection
Manual Transmittal Notice. Additional information regarding the 1988 FIFRA Amendments will be
forwarded as it becomes available.
In order to help us update the Manual so that it remains a usable 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 Robert Kaneshiro, chairman of
the work group.
The Manual was compiled by a work group of representatives from Headquarters, regional, and
National Enforcement Investigation Center (NEIC). Assistance, comments, and suggestions were
provided by all regional, NEIC, Headquarters, and the State FIFRA Issues, Research, and Evaluation
Group (SFIREG) Committee. Work group meetings we re held in Washington, D.C., and Region IX along
with several conference calls to discuss, revise, and finalize the Manual. Those heading the work group
include the following:
Robert Kaneshiro, Chairman, Region IX
Michael Hackett, Project Coordinator, Headquarters
Robert Kalayjian, Region I
Carlton Layne, Region IV
John Ward, Region V
Dave Ramsey, Region VII
Lyn Frandsen, Region X
Special thanks also go to other Headquarters and NEIC staff who made substantial contributions:
William Danson, Headquarters
John Ellison, NEIC, Denver, CO
John Foley, Headquarters
Marged Harris, Headquarters
Dean Hill, NEIC, Denver, CO
John Mason, Headquarters
Pesticides Inspection Manual i January 1989
-------
DISCLAIMER
This manual has been reviewed by the Office of Compliance Monitoring, U.S. Environmental
Protection Agency, and approved for publication. This guidance represents EPA's recommended
procedures for conducting FIFRA compliance inspections only. Failure on the part of any duly
authorized official, inspector, or agent to comply with its contents shall not be a defense in any
enforcement action; nor shall failure to comply with 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.
Pesticides Inspection Manual ii January 1989
-------
TABLE OF CONTENTS
Chapter One: Administration
Introduction 1
Standards of Professional Conduct 1
Professional Attitude 2
Attire 2
Industry, Public, and Consumer Relations 2
Gifts, Favors, and Luncheons , 3
Recordkeeping 3
Knowledge Required of an Inspector 3
Documentary Support 4
Disclosure of Official Information 7
Chapter Two: Pesticide Law and Definitions
The Federal Insecticide, Fungicide, and Rodenticide Act, as Amended 1
Statutory Authority for Pesticide Regulations 65
FIFRA Amendments of 1988 65
Definitions 66
Chapter Three: Registration
Product Registration 1
Registration Procedures 3
Chapter Four: Federal/State Cooperation
Authority 1
Background 2
Responsibility 3
Chapter Five: Experimental-Use Permit Investigation
Authority 1
Objectives 1
Responsibility 2
Conducting the EUP Investigation 3
Reporting 3
Pesticides Inspection Manual iii January 1989
-------
Table of Contents
Chapter Six: Cancellation and Suspension
Authority 1
Objective : 2
Policy 2
General 2
Procedures 2
Chapter Seven: Establishment Registration
Chapter Eight: Books and Records Inspections
Authority 1
Objectives 1
Policy 1
Procedures 2
Records Required 3
Child-Resistant Packaging 4
Chapter Nine: Producer and Marketplace Establishment Inspections
Authority 1
Policy 1
Producer Establishment Inspections 1
Marketplace Inspections 4
Bulk Repackager Inspections 5
Preparing the Inspection Reports 6
Chapter Ten: Interagency Pesticide Referrals
Authority 1
Objective 1
Policy 1
Procedures 1
Chapter Eleven: Pesticide Product Sampling
Authority 1
Objectives 1
Policy 1
Sample Collection 2
Sample Documentation 6
Sample Preparation, Custody, and Handling 11
Pesticides Inspection Manual iv January 1989
-------
Table of Contents
Chapter Twelve: Stop Sale. Use, or Removal Orders
Authority 1
Objectives 1
Policy 1
Procedures 2
Chapter Thirteen: Recalls
Recalls 1
Chapter Fourteen: Use/Follow-Up Enforcement Investigations
Authority 1
Objectives 3
Policy 3
Use Inspections 3
Follow-Up Investigations 6
Appendix
Chapter Fifteen: Pesticide Import and Export Program
Authority 1
Objectives 1
Policy 1
Procedures 2
Chapter Sixteen: Disposal
Chapter Seventeen: Warrants
Authority 1
Objective 1
Policy 1
Procedures 2
Chapter Eighteecn: Safety
Objective 1
Responsibilities 1
Safety Equipment 1
Safe Handling of Pesticides 3
Emergency Treatment 5
Recommended Safety Equipment for Inspectional and Sampling Activities 6
Pesticides Inspection Manual v January 1989
-------
Table of Contents
Chapter Niaeteen: Appearing as a Witness
Objective 1
Prehearing Preparation and Personal Appearance 1
General Conduct in Courtroom and Vicinity 2
Proper Technique on the Witness Stand 2
The Direct Examination 3
Cross Examination 4
Proper Conduct After Trial 5
Expert Witness 5
Chapter Twenty: FIFRA Criminal Enforcement
Introduction 1
The Criminal Provisions of FIFRA 1
The State and Federal Roles in Criminal Enforcement of FIFRA 2
FIFRA's Relationship to Other Federal Criminal Laws 2
Overview of Criminal Enforcement 2
Recognizing Potential Criminal Violations 3
Case Studies 10
Pesticides Inspection Manual vi January 1989
-------
Chapter One
ADMINISTRATION
Page No.
INTRODUCTION 1
STANDARDS OF PROFESSIONAL CONDUCT 1
PROFESSIONAL ATTITUDE 2
ATTIRE 2
INDUSTRY, PUBLIC, AND CONSUMER RELATIONS 2
GIFTS, FAVORS, AND LUNCHEONS 3
RECORDKEEPING 3
Time 3
Travel 3
KNOWLEDGE REQUIRED OF AN INSPECTOR 3
DOCUMENTARY SUPPORT 4
Field Notebooks 4
Inspection Entries 4
Affidavits 5
Statements 5
Photographs 6
Drawings and Maps 6
Printed Matter 7
Mechanical Recordings 7
DISCLOSURE OF OFFICIAL INFORMATION 7
Requests for Information by the Trade or Public 7
Confidential Information 8
Pesticides Inspection Manual 1-i January 1989
-------
Chapter One Administration
Pesticides Inspection Manual 1-ii January 1989
-------
Administration
-------
Chapter One
ADMINISTRATION
This manual is intended for use by inspectors conducting pesticide inspections under authoriza-
tion of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. Procedures
and forms have been recommended, but equivalent state procedures and state forms may be sub-
stituted where appropriate.
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 pesticides use. An energetic
enforcement program, fairly but firmly administered, is the best guarantee that EPA will be success-
ful. An effective enforcement program is generated by well-trained, qualified field personnel con-
ducting inspectional activities and investigations to (1) detect violations and (2) collect evidence
necessary to successfully prosecute FIFRA violators and to remove potentially violative pesticides
from distribution and use. 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 confront an active, dynamic inspectional staff; however, it should enable field personnel to
operate in an effective, knowledgeable manner in most circumstances.
While this manual is primarily for use by EPA inspectors, it may be valuable in orienting and
training state inspectors and other regional personnel involved with pesticide enforcement work.
STANDARDS OF PROFESSIONAL CONDUCT
Through many years of inspectional experience, EPA has developed procedures and require-
ments that ensure ethical action on the part of its inspectors. These ethics have been established to
protect the individual, the Agency (EPA), and industry as well. Because inspectors act as officers of
the United States government, they should 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 Agency.1 As such, the following rules of ethics should be observed at
all times:
'Individual states have developed their own means of ensuring ethical action and their procedures
and requirements should also be considered at all times.
Pesticides Inspection Manual 1-1 January 1989
-------
Chapter One Administration
o All investigations shall be conducted within the framework of the United States Constitu-
tion and with due consideration for individual rights, regardless of race, sex, creed, or
national origin.
o The inspector shall uphold the Constitution, laws, and regulations of the United States and
all governments therein and never be a party to their evasion.
o Never use any information obtained confidentially in the performance of governmental
duties as a means for making private profit.
o Any act (or failure to act) that might be construed as being motivated by personal or
private gain (conflict of interest) should be avoided.
o Never discriminate by dispensing special favors or privileges to anyone, whether for
remuneration or not; and never accept, for yourself or your family, favors or benefits
under any circumstances.
o Facts of an investigation are to be developed and reported completely, objectively, and
accurately.
o Make no promises of any kind; government employees cannot bind government
enforcement.
o The inspector shall 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, establishing an atmosphere of cooperation through
a firm but responsive attitude.
ATTIRE
Good public relations and practical common sense require appropriate dress for inspectional
activity. Protective clothing is required for many inspections. Coveralls or other clothing is available
for this purpose. Inspectors should wear any safety equipment that may be customary in the establish-
ment being inspected. Chapter 18 provides additional information on proper dress.
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 should introduce himself/herself by name, title,
and organization, present his/her credentials, and explain the purpose of the visit. The inspector
should 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.
Pesticides Inspection Manual 1-2 January 1989
-------
Chapter One Administration
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 inspectional tours. This should 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 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. 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:
o How to substantiate all facts with statements of witnesses or items of evidence.
o How to evaluate what evidence is necessary to obtain successful civil action, criminal
prosecution, or seizure.
o How to obtain respect, inspire confidence, and maintain the good will of the public, indus-
try, and consumers during interviews.
o How to testify in court.
o How to conduct sampling procedures in a safe and professional manner.
o How to detect discrepancies or lack of good faith during interviews.
o How to be accurate, thorough, unbiased, and fair while conducting an investigation/-
inspection.
Pesticides Inspection Manual 1-3 January 1989
-------
Chapter One Administration
To carry out their duties, inspectors must be thoroughly familiar with the legal basis for their
actions. An inspector must be thoroughly knowledgeable about FIFRA and all regulations and
policies promulgated thereunder.
In addition, an inspector should be familiar with certain other administrative laws:
Toxic Substances Control Act (TSCA)
Federal Food, Drug, and Cosmetics Act (FFDCA)
Resource Conservation and Recovery Act (RCRA)
Safe Drinking Water Act (SDWA)
Clean Air Act (CAA)
Federal Water Pollution Control Act (FWPCA)
Clean Water Act (CWA)
Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)
Superfund Amendments and Reauthorization Act (SARA)
Hazardous Materials Transportation Act (HMTA)
Occupational Safety and Health Act (OSHA)
Endangered Species Act (ESA)
Appropriate state pesticide and environmental legislation
DOCUMENTARY SUPPORT
In addition to physical samples, documentary support is necessary for an effective case. These
documents may include field notebooks, affidavits, statements, copies of records, photographs,
drawings and maps, printed matter, and mechanical recordings. See Chapter 11, Sampling, for addi-
tional 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. (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
should contain only facts and pertinent observations; and the language should 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 should be included in the field notebook:
o Observation. Record all conditions, practices, and other observations that will be useful in
preparing the inspection report or will contribute to valid evidence.
o Unusual Conditions and Problems. Note and describe in detail any unusual conditions and
problems encountered during the course of the inspection visit.
o 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.
Pesticides Inspection Manual 1-4 January 1989
-------
Chapter One Administration
Affidavits
The affidavit2 is a sworn statement taken by the inspector relating to personal firsthand knowl-
edge of a potential violation. The affidavit may be used to substantiate the violation or to set the cir-
cumstances surrounding the potential violation. Careful review should be made of the affidavit for
evidence in support of an enforcement action. The person making the affidavit must sign it and be
able to verify personally the facts contained in the statement. In addition, the inspector should sign
the affidavit as a witness.
An affidavit is used to obtain a clear and concise written record of factual information relating
to a suspected violation. The oath taken by the person making the affidavit serves to substantiate the
truth of the statement. Affidavits may be used to verify the dates obtained from a facility's records
(e.g., the date of shipment). The affidavit should contain the following:
o Identity of the affiant;
o The reason for taking the affidavit;
o The pertinent facts in a simple narrative style, arranged in chronological order; and
o A concluding paragraph indicating that the affiant read and understood the statement.
In addition, any corrections made to the final copy must be initialed by the affiant.
Statements
Statements may be obtained from persons having firsthand knowledge of 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:
o Determine the need for a statement. Will it provide useful information? Is the person
making the statement qualified to do so by personal knowledge?
o Ascertain all the facts and record those which are relevant and which the person can verify
in court. Make sure all information is factual and firsthand. Avoid taking statements that
cannot be verified personally.
o In preparing a statement, 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.
o Positively identify the person making the statement (name, position, address, etc.).
o Show why the person is qualified to make the statement.
2Only those inspectors or employees who have been authorized by the Administrator of EPA or
his/her designee are permitted to administer oaths, affidavits, or affirmations.
Pesticides Inspection Manual 1-5 January 1989
-------
Chapter One Administration
o Present all pertinent facts.
o Read the statement to the person (preferably in the presence of a witness) and make any
necessary changes, initialing all corrections or changes.
o 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.
o Have the person sign the statement. The inspector should also sign and date the statement.
Be sure to provide a copy of the statement to the signer if requested.
o 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 have read the statement and
it is true, but I am not signing it 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.
Photographs
The documentary value of photographs ranks high as admissible evidence. Clear photos of
relevant subjects, taken in proper light and at proper lens setting provide an objective record of
conditions at the time of inspection.
Polaroid-type instant photos should 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
should be transferred to the photo itself. All photo information should 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 should not be taken in areas where there is a danger of explosion. If there is a
danger of electrical shock, photos should be taken from a safe distance.
To avoid difficulties arising from confidential claims surrounding photographs, it is recom-
mended that all unnecessary background be shielded or that the subject be moved before the photo-
graphs 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.
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 objects, and other information which, in com-
bination with samples, photographs, and other documentation, can produce an accurate, complete
evidence package. Drawings and maps should be simple and free of extraneous details. Basic
Pesticides Inspection Manual 1-6 January 1989
-------
Chapter One Administration
measurements should be included to provide a scale for interpretation and compass points should be
included.
All drawings, maps, etc., should be identified with the inspector's initials, the date, sample
number, and any other pertinent information.
Printed Matter
Brochures, literature, labels, and other printed matter shall provide important information
regarding a firm's conditions and operations. These materials may be collected as documentation.
All printed matter should 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. However, the
Freedom of Information Act (FOIA), which dictates this policy, also cites nine classes of exemptions
to this policy:
o Matters of national defense or foreign policy;
o Internal agency rules;
o Information exempted by other statutes;
o Trade secrets, commercial, or financial information (Confidential Business Information);
o Privileged inter- or intra-Agency memoranda;
o Personal privacy;
o Investigatory records compiled for law enforcement purposes;
o Records of financial institutions; and
o 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.
Pesticides Inspection Manual 1-7 January 1989
-------
Chapter One ^ Administration
o 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.
o Withhold Documents. If the document in question falls into one or more of the nine
exemption categories, it may not be released.
o 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 un-
intelligible nonexempt record, this nonexempt information shall be released.
o 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(a), (b), and (c) and Section 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"
should 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:
o The name of the recipient of the copy;
o The intended purpose for which the copy is to be used; and
o 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.
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 procedures called for in the Freedom of
Information Act Regulations 40 CFR 2 are to be complied with.
All such requests must be referred to the regional office.
For more information concerning confidential information, refer to the FIFRA Confidential
Business Information Security Manual.
Pesticides Inspection Manual 1-8 January 1989
-------
Pesticide Law and
Definitions
-------
Chapter Two
PESTICIDE LAW AND DEFINITIONS
Page No.
THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT,
AS AMENDED (FIFRA) 1
STATUTORY AUTHORITY FOR PESTICIDE REGULATION 65
FIFRA AMENDMENTS OF 1988 65
DEFINITIONS 66
Pesticides Inspection Manual 2-i January 1989
-------
Chapter Two Pesticide Law and Definitions
Pesticides Inspection Manual 2-n January 1989
-------
Chapter Two
PESTICIDE LAW AND DEFINITIONS
THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT,
AS AMENDED (FIFRA)
AN ACT
To regulate the •"•'"'•fl of economic poisons and devices, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the United
States of America in Congress assembled,
SECTION 1. (pnc. 121) SHORT TTT1X AND TABU Of
(a) SHORT TITLE.— This Act may be cited as the "Federal Insecticide,
Fungicide, and Rodenacide Act".
(b) TABLE OF CONTENTS. —
Section 1. Shon title aid table of content!.
(*) Shon title.
(b) Table of ~»**""
Sec. 2. Definition!.
(a) Active ngndient,
(b) Admimitmor.
(c) Adulterated.
(d) Anunal.
(e) Certified applicator, etc
(1) Certified ipplirator.
(2) Ptivaie applicator.
(3) Commercial applicant.
(4) Under the direct ropervuion of a certified applicator.
(0 Defoliant
(|) DeaiccanL
(h) Device,
(i) Dinrict court.
0) EovifonincDt.
(K) PuntTU.
hazard.
(m) ben intredieni.
(n) Infrediera naiement
(o)In*ea.
(p) Label and labtlin|.
(1) Label
(2) Labelint.
(q) Micbranded.
(r)Neraaiode.
(i) Perton.
(t) Pen.
(u) Petocide.
(v) Plant regulator.
(w) Producer aad produce.
(x) Protea health and the environment
(y) RcfuumL
(z) Refimiion.
(aa) State.
(bb) UrurnoniHe advene effecu on the environment.
(cc)We«t
(dd) Enabliihmem.
(ee) To ute any retinered peiticide in a manner iaeontisteni with its Ubelmg.
(ft) Ouutandini data requirement.
(gg) To distribute or tell.
Sec. 3. Retutnoon of petticidei.
(a) Requirement of reparation.
(b) Exeraptioni.
(c) Procedure for registration.
(1) Statement required.
Pesticides Inspection Manual 2-1 January 1989
-------
Chapter Two Pesticide Law and Definitions
nFRA
(2) Dm in rapport of retjmacn.
(3) Tim* for acting with ncpea to appticaonn
(4) None* oT.
(5) Approval (
I of pato'cida*.
(1) QaiaificaiMB lor general uae, iwirictad ota, or tan.
(3) Qiange • clatrifkatica from i
(t) Products with tan* fonnabaon and <
(0 MitceHaneout.
(1) Effect of i
(2) RogifBanon not a <
(3) Authority to <
See. 4. Rereginratian of i*
(a) General rale.
(b) RenfuuMan pbua.
(c)FhaM OM.
(1) Pnocuy for mcy m iikm.
SRcretiinucn lijts.
Jodkiai review.
(4) Nodoi to icfianau.
(d)PhM*two,
(1) b genmL
(2) Nonce of mtem to wok or not to wefc
(3) MiMtni or iniri>«|n«M d«ft,
(4) Tnn» period*.
(5) OoeeUMiM nd moraL
(6) Sommirioni tad pnuhirt
(e){%*M three.
(1) InfonBitioD tbooi sttxtio.
(0 Pbae* foor.
(1) h>kpmUau nview end iilenifii ilim of
-------
Chapter Two Pesticide Law and Definitions
RFRA SK.1
(0 Sum iiin ace of penoiu.
(l) Esempacn for ajricntanl reaearcn t|CKlts.
Sec, 6. Adminiitrair
(•) Caw»lletioB afar five yean.
fOfnaanL
ID dmifictfioB w litals*
(2) Hipmtiir
(3) Emergency ordo.
(4) Jndicui review.
(d) Pofalic hMiiai* tad "•'-••••**• review.
(0 Gcaeni proviuoe*.
m Vatannry ceD
(2) Pnbtictticn of notice.
(l) Notice for oared ptiricidn with onoded or impended rop
(l)IhtenenL
(2)Co|Mi.
(h) Jodictti review*
(•) Reqeincaenu.
(c)InfoBMoaaieqand.
(d) CordWentiel reoord» end atfarmitiaa.
(•)
(b)
Reqmicmeni.
Inspecoon.
(•) In ejeoenL
(b) Wimnu.
(c) Enfotcanem.
(1) Ccrafimioer of ficu uxAtumey Garni.
(2) NoBice not raqaiied.
(3) Wennuff naaeet.
Sec. 10. Pimeaiui of ndt teems tod other mfotuiaoo.
(•)InfenaiL
(b) Oudonim.
(e) Diidomm to oomnaon.
(f) Penally for disclosure by Fedenl employeei.
(4) OUdofm to fereitn and nmiitnaoontl p^nr^* prodncen.
Sec. 11. UM of restricted use pethcidts; «pplicilor».
(a) Cenifkaban procedure.
(1) Fedeal cenficatioa
(2) State cenificaiian.
(b) SUM plrax
(c) Iiutniaic* in jmrgniad pest management techniques.
(d) In genenL
(e) Sapeaw •undardi.
Sec. 1L Unlawful act*.
(b)E
Sec. 13. Stay talo, ate; icmovaU and seiznre.
(a) Stop sale, etc, orden.
(b) Seiznre.
(c) Dispoution after mndrmiation
(<*) Coun costs, ttt
Sec. 14. Peoatou.
(a) Ovfl penalties.
(1) In gbiertL
(2) Privur applicaior.
(3) Heahnq.
(4) Oeterminaiian of penalty.
(5) Reference to Anomey CenenL
Pesticides Inspection Manual 2-3 January 1989
-------
Chapter Two Pesticide Law and Definitions
S«C. 1 RFRA
(b) O*>B>*P*I' pcoiitics*
'
(3)Di
(4) Ac
Diiciomc of Buonmtun.
Ae»o/<
SbgwraL
Exception.
(3) Report.
(4) Appropriation.
(b) Indenaficaaon of and turn, dealer*. and distributors.
(1) Bad users.
(2) Deeters sad disaibMon.
(3) Scarce.
(c) AnwuB of payment
(1) In general.
(2) Special role.
|^ A J^»i««i«a^»«i»^ ^^•u^uAn^^ !ii_jl^ _m j.1 «
10* *«"""<"• •••»•• pfoooomt JOQICUI i
(•) Oteria ooan review.
(b) Review by Coun of AppeeU.
(c) Jurisdiction of district conns.
(d) Notice of judgments.
See. 17. Imports and exports.
(•) Pettiddes tod devioef intended for export.
(b) ^*~*"»^" DODCM fumiibed to foreJtn fovcnmeots.
(c/ InipoitMioB OK pecDcidei CBd devioes.
(d) CoopenQon in loumiioBil cffora.
(e) RefuUaoo*.
See. 18. Einmprinn of Fedenl sad
See. 19. StoiBte, dupotil, tmupomtica, tnd nolL
(•)
(1) 0«u requiitoMDU end refumaao of pecncidei.
(3) <^""^J«. rinien^ cod other nmnriili.
(b) Recalls.
(2) VoAiattry reeelL
(3) Mnduory neeJL
(4) Recall procedure.
(5) Contenu of recall plan.
(6) Reqinrcnieflu or proceduiei.
(c) Stonge eons.
(1) SubmiuioD of pUn.
(3) xCemtaorMflient.
(d) Admininnrinn of nonge, disposal, tnmportinon, and recall profmn*.
(1) Votomary ifreemeDU.
(2) Rule and regulation review.
(4) Seiam and penalties.
(e) Cantainer design.
(f) Pesticide reridn
(1) Procedures.
(2) Compliance.
(3) Solid Waste Disposal ACL
(l) Pesticide eontamer study.
(1) Study.
(2) Report.
- (h) Relationship to Solid Waste Disposal Act.
Sec. 20. Research and monnonng.
(a) Research.
(b) National monitoring plan.
(c) Monitoring.
Sec. 21. Solicitation of «»^»^"«' notice of public hearings.
Pesticides Inspection Manual 2^ January 1989
-------
Chapter Two Pesticide Law and Definitions
RfflA
(a) SacRUty of Afhcalnire.
(b)Viewt
(c) Nonce.
Sec. 22. Dtlt|Minn a*d ooopemioB.
S«H> 29* Slttft ooopflnttQQ, Mfl* fl
(b) CODDMtt IOC MUlMlft*
Sec. 24. Anthony of State*.
(a) In t~— '
(b) Umfonmty.
(e) Addfeie
Sec. 25. Authority at
(a) In General.
(4) CaBtmttaaal revie
(b) EULBBttOD
-------
Chapter Two Pesticide Law and Definitions
S«C.2 BHU 8
(d) ANIMAL.—The terra "animal" means all vertebrate and invertebrate
species, including but not limited to nan and other mammal^ birds, fish,
and shellfish.
(e) CERTIFIED APPLICATOR, ETC.—
(1) CBKIWIBD APPLICATOR.—The seem "certified applicator" means
any indfrutaal who i§ certified under section 4 ** as amttorgff to use
or supervise the use of any pesticide which is classified for restricted
use: Any applicator who holds or applies registered pesticides, or use
dilutions of registered pi-stir idr-s consistent with section 2(ee) of this
Act only to provide a- service of controlling pests without delivering
any unapplied pesticide to any person so served is- not deemed to be a
y»Hfr or distributor of pfHiCTJf* iif>
-------
Chapter Two Pesticide Law and Definitions
RFRA
bacteria, except those oo or in living ma> or other animals and dune on or
ia processed food, beverage* or phaanacenticals.
(I) IMMINENT HAZARD.—The term "imminent hazard" means a situation
which exists when the continued use of a> putrioe 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 surviv-
al of a species declared endangered by the Secretary of the Interior under
Public Law 91-135.
(m) INERT INGREDIENT.—The term "men ingredient" means an ingredient
which is not active.
(n) INGREDIENT STATEMENT.—The term "ingredient statement" means a
statement which contains—
(1) the name and percentage of each active ingredient, and the total
percentage of all inert 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, nlcnlard a§ elementary
arsenic
(o) INSECT.—The term "insect" means any of the numerous small inver-
tebrate animals generally having the body more or less obviously segmented,
for the most pan belonging to the class insecta, comprising six-legged, usu-
ally 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.
(p) LABEL AND LABELING.—
(1) 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.
(2) 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) to which reference is made on the label or in literature ac-
companying the pesticide or device, except to current official pub-
lications of the Environmental Protection Agency, the United
States Departments of Agriculture and Interior, the Department of
Health and Human Services, State experiment stations. State agri-
cultural colleges, and other similar Federal or State institutions or
agencies authorized by law to conduct research in the field of pes-
ticides.
(q) MBBRANDED.—
(1) A pesticide is misbnnded if—
(A) its labeling bears any statement, design, or graphic represen-
tation relative thereto or to its ingredients which is false or mis-
leading in any particular
(B) it is contained in a package or other container or wrapping
which does not conform to the standards established by the Ad-
mintitrator pursuant to section 25(cX3);
(Q it is an imitation of, or is offered for sale under the name of,
another pesticide;
(D) its label does not bear the registration number assigned
under section 7 to each establishment in which it was produced;
(E) any word, statement, or other information required by or
under authority of this Act to appear on the label or labeling is not
Pesticides Inspection Manual 2-7 January 1989
-------
Chapter Two ^ Pesticide Law and Definitions
S«c.2 BFRA _ 10
prommently placed thereon with such conspicuottsness (as con*
pared with other words, statements, designs, or graphic natter in
the labeling) and in such leans as to reader it likely to be read and
by the ofdioaty indiv*/*"**
and
. •-»--** -- AMMMHM^^^M*^ £* -• --- Birrf nn«a«i^ ill^mj i •!• fn*
BIDE^Dfliv ••CCQniOHBy^BK tt DDQ3- DDK ODDDiul ^DIvCuuDS TOT
are- necessary for rffacoag the purpose for which the
pjpdua is intended and if complied with, together with any re-
apmaaiis impased under section 3(d) of this Act, are adequate to
paotect health wd ne em>iiiininfnt;
(G) the lnhf! does not M"iiin a •*"»"'g or caution statement
which may be necessary and if complied with, together with any
requirements imposed under section 3(d) of this Act, is adequate to
protect health and the environment; or
(H) in the case of a pesticide not registered in accordance with
section 3 of this Act and intended for export, the label does not
r*?>>taitt. in winds prominently placed thereon with such conspicu-
ousness (as- compared with* other words* ffmifftnffTrt!p» desisns, or
jrephic matter in the labeling) as to render it likely to be noted by
ijufr ordinary individual 'i"^^ customary conditions of purchase and
use, the following: "Not Registered for Use in the United Slates of
America".
(2) A pesticide is misbranded if—
(A) the label does not bear an ingredient statement on that port
of the immediate container (and orr die outside WMtHinfr or wrap-
per of the retail package, if there be one, through which the ingre-
dient statement on the «"«"«*«tiq^» T^WT cannot be clearly read)
which is presented or displayed under customary conditions of pur-
chase, except that a pesticide is not nrisbranded under this subpara-
gmphif—
(i) die size of form of die immediate container, or the out-
side container or wrapper of the retail package, makes it im-
practicable to place the ingredient statement on the part which
is presented or displayed under customary conditions of pur-
chase; and
(ii) the ingredient statement appears prominently on another
pan of the 'mnw^j^f* container, or outside container or wrap-
per, permitted by the Administrator,
(B) the labeling does not contain a statement of the use classifi-
cation under which die product is registered;
(Q there is not affixed to its container, and to the outside con-
tainer or wrapper of die retail package, if there be one, through
which die required, information on die i in modi am container cannot
be clearly read, a label bearing—
(i) the name and address of the producer, registrant, or
person for whom produced;
(ii) me name, brand, or trademark under which the pesticide
is sold;
(iii) the net weight or measure of the content, except that
die Administrator may permit reasonable variations; and
(iv) when required by regulation of the Administrator to ef-
fectuate die purposes of this Act, the registration number as-
Pesticides Inspection Manual 2-8 January 1989
-------
Chapter Two Pesticide Law and Definitions
IT FffRA Ste.2
signed- to die pgsricfdy under ft*** Act* and the
tion;and
(D) the pesticide ""*"•"** any substance or flrt?nawf-i in quanti*
"*•" T***?*- !*** label «h»H bCV, lit MMltKffl tO
matter required by thfe Act—
(i)dw skull and. aossbones;
(ii) the won! "poison" prominently in- red on a. background
of dBDncriy coMnsong-cdot; «ad_ ___
Oil) 9 flK0DGn& of A' ontcQcsi* OHKnwm (first Aid of ochor^
wise) in gag of poisoning1 by tfag pftttridft
Or/ NHMATOOB^ "••Toft tcmx ocottiouo IDOVK mvcftBOKettaT flDimu^ of IDS
pbylun> nemathdnrimfaes and class ncmatoda. that av nnrgmfntrri round
wonn» with *'~'grt^<; fusiform, or sacliks bodies covered wub cuticle, and
» joil, water, p**"^. OK plant pans; nay also bs r****<* ncnun or
eelwonns>
(s) PBRSON.— The: tenn "peraon" means any individnal. partnership, asso-
ciarioTti coipoiaiionv or any ofgHiiiind grotip ot penpns whether incdipojued
or not.
(t). PEST.— The term "pest'* means (1) any insect, rodent, ncmacxlr,
fungus, weed; or (2) any other tern of terrestrial: or aquatic plant or animal
life? or vims, bacteria, or other micro-organism (except viruses, bactrna, or
other micro*organisms on oar iff Irving; man or other Irving mnmah) which
the Administrator declares ta be a- pest under section 25(cXl).
(u) PESTKIDH.— Tbet tennv--*pesticide/'r means (1) any fnfrttaiK'*' or mixture
of substanccS' intended for/'pFCvcntinff, flfflHpyy'pff, ropcllinc or nuoganng'
any pest and (2) any substance or mixture of mbnances mtended for use as
a plant regulator; defoliant; or dmirranf, except that die* term? "pesticide"
ghnii nqr tnclndg any article dtttis'a:"new y*""! drug" within the meaning
of section 201(w) of the Federal Food; Drag; and Cosmetic Act (21 U.S.C.
32I(w))» dot has been determined by the Secretary of Health: and Human
Services not to.be & new """"t|i drug by & regulation fnahli^iirg conditions
of use. for the article; or dm is an animal feed within die meaning; of section
201(x) of sodr Act (21 U^.C 321(x)) bearing; or contaming s new animaL
drug.
(v) PtANT RflOUATOt— The tent "plant regulator" means any substance
or mixmre of substances intended, mrotigb physiological action, for acceler-
ating or retarding the rate of growth or rate of maturation, or for otherwise
altering; die behavior of plants, or die produce thereof, but shall not include
SQuStflDCCS (0 tu& CXtBDt tbflt tDflV" aUlfr ffltCOuOu flA> DlflttC OOttlCBtt* tMCO CiO*
flVM^MMMI Bk*««pj«jj^B^K| «»|fe^MM«tf*«kl A ••I^^M* •••«I«»«I^J1»* A«Kj4 ^MM! ^^^k^Mk^t«Mk^M»4M A t^tf%
IDCnCv%< UUlUUwDBL COBuuCSUS* ul^auL imJmjQmUJx vVaU 9DU lODCO^BDBO^B* ««hlO«
die term, "plant regulator" shall not be required to include any of such of
those nutrient. HIIXUITM or soil ameiidintiits as are commonly known as vita*-
OUfl"ftODX10O& uQ^dCQullZcU DfOQUCO» iPtCOflBfl' lOT UDDVDVttDOtt* OUttDfiBflflDCC*
survival, health, and propagation of plants, and as are not for pest destruc-
tiov and are nontoxic, nonpoisonous in die undiluted packaged concentration.
(w) PRODUCER AND PRODUCE.— The term "producer" means die person
who manufacturers; prepares^ compounds, propagates, or processes any pesti-
cide or device or active ingredient used in producing a pesticide. The term
"produce'' means to manufacture; prepare, compound, propagate, or process
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 die directions on registered labels shall not of itself result in
Pesticides Inspection Manual 2-9 January 1989
-------
Chapter Two Pesticide Law and Definitions
S«C.2 _ RRU _ 12
such individuals being included in the definition of "producer" for the pur-
poses of this Act.
(x) PROTECT HEALTH AND THE ENVIRONMENT.— The terms "protect health
and the enviaautcat" and "protection of health and the environment" mean
protection *gy *™* ""y *><'"*^TT*t%** *ttnf*** effects on the environmenL
(y) RiGBTRANT.— The term "iriraiart" means a person who has regis-
tered any pesticide pursuant to (be (iiivuiuui of this Act.
(z) Rm» i RATION.— The term "registration" Tnctudftt rereguuunon.
(aa) STATE.— The term "State" means a State, the District of Columbia,
the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Trust Ter-
ritory of the Pacific T«I«U<« and American ^"""ft
(bb) UNSEASONABLE ADVERSE EFFECTS ON THE ENVIRONMENT.— The term
OB
risk, to man or the environment, taking into account die economic, social,
environmental COBS w\ ImiffiH of the use of any
(cc) WEED.— The term "weed" means any plant which grows where not
wanted.
(dd) 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.
(ee) To USB ANY REGISTERED PESTICIDE IN A MANNER INCONSISTENT Wrra
ITS LABELING.— The term "to use any registered pesticide- in & manner in-
consistent with its labeling" means to use any registered pesticide in a
manner not permitted by the labeling, except that the term shall not include
(1) applying a pesticide at any dosage, concentration, or frequency less than
that specified on the labeling unless the labeling specifically prohibits devi-
ation from the specified dosage, concentration, or frequency, (2) applying a
pesticide against any target pest not specified on the labeling if the applica-
tion is to the crop, animal, or sit* specified on die labeling, unless the Ad-
ministrator has required that the labeling specifically state that the pesticide
may be used only for the pests specified on the labeling after the Adminis-
trator has determined that the use of the pesticide against other pests would
cause an unreasonable adverse effect on the environment, (3) employing any
method of application not prohibited by the labeling unless the labeling spe-
cifically stales that the product may be applied only by the methods speci-
fied on the labeling, (4) mixing a pesticide or pesticides with a fertilizer
when such mixture is not prohibited by the labeling, (5) any use of a pesti-
cide in conformance with section 5, 18, or 24 of this Act, or (6) any use of a
pesticide in a manner that the Administrator determines to be consistent with
the purposes of this ACL After March 31, 1979, the term shall not include
the use of a pesticide for agricultural or forestry purposes at a dilution less
before
than label dosage \«"i^sy before or after tfvtt ^•'* die Arfinini^yyfqf issues a
regulation or advisory opinion consistent with dw smdy provided for in sec-
tion 27(b) of the Federal Pesticide Aa of 1978, which regulation or advisory
opinion specifically requires die use of definite amounts of dilution.
(ff) OUTSTANDING DATA REQUIREMENT. —
(1) IN GENERAL.— The term "outstanding data requirement" means a
requirement for any study, information, or data that is necessary to
make a determination under section 3(c)(S) and which study, informa-
tion, or data —
(A) has not been submitted to the Administrator; or
(B) if submitted to the Administrator, the Administrator has de-
termined must be resubmioed because it is not valid, complete, or
Pesticides Inspection Manual 2-10 January 1989
-------
Chapter Two Pesticide Law and Definitions
13 RFHA 34C.3
adequate to make a determination under section 3(c)(5) and the
romilarimi€ qivj guidelines '^IIQtl UIKlfT Blfll ^fctiffll
(2) FACTORS.—In making a determinacion under paragraph (1)(B) re-
specting a stndy, the Adnunisntor shall ftiaminf, at a minimum, rele-
vant protocols, *f ""«*fftnrimi of |f|g ffmchift and analysis of the study,
and the results of die study to determine whether the study and the re-
sults of the study fulfill the data, requirement for which the study was
submitted to the Administrator.
(gg) To DISTRIBUTE ox SELL.—The torn "to distribute or sell" means to
distribute, sell, offer for sate, hold for dtsnbuacn, hold far sale, bold 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 USB dilutions thereof by
any applirirffl1 who provides a service of controlling pests without delivering
any unapplied pesticide to any person so served.
SBC 3. (13fa| REGISTRATION OF PESTICIDES.
(a) REQUiREMeNT OF REGISTRATION.—Except as provided by this Act, no
person in any State may distribute or sell to any person any pesticide that is
not registered under this Act To the extent necessary to prevent unreason-
able adverse effects on the environment, the Administrator may by regula-
tion limit the distribution, sale, or use in any State of any pesticide that is
not registered under this Act and that is not die subject of an experimental
use permit under section 5 or an emergency exemption under section 18.
(b) EXEMPTIONS.—A pesticide which is not registered wim die Administra-
tor may be transferred if—
(1) die transfer is from one registered establishment to another regis-
tered establishment operated by the same producer solely for packaging
at the* second establishment or for use as a constituent part of another
pesticide produced at the second establishment; or
(2) die transfer is pursuant to and in accordance wirn die require-
ments of an experimental use permit.
(c) PROCEDURE FOR REGISTRATION.—
(1) STATEMENT REQUIRED.—Each applicant for registration of a pesti-
cide shall file with die Administrator a statement which includes—
(A) die name and address of the applicant and of any other
person whose name will appear on die labeling;
(B) die name of die pesticide;
(Q a complete copy of dw labeling of die pesticide, a statement
of all claims to be made for it, and any directions for its use;
(D) except as otherwise provided in paragraph (2)(D), if request-
ed by die Administrator, a full description of die tests made and
die results diereof upon which the claims are based, or alternative-
ly a citation to data that appear in die public literature or diat pre-
viously had been submitted to die Administrator and that die Ad-
ministrator may consider in accordance with the following provi-
sions:
(0 with respect to pesticides containing active ingredients
that are initially registered under this Act after the date of en-
actment of die Federal Pesticide Act of 1978 [September 30,
1978], data submitted to support die application for die origi-
nal registration of the pesticide, or an application for an
amendment adding any new use to die registration and that
pertains solely to such new use, shall not, wiUnut the written
Pesticides Inspection Manual 2-11 January 1989
-------
Chapter Two Pesticide Law and Definitions
S4C.3 _ HFHA _ 14
ponnission of the original data rohmincr. be considered by the
Adminisaator to support an application by another person
during a period of ten years following the date the Adminis-
trator Gist registers the pcstiridft. except **"*? such permission
shall not b* required in the case of defensive' data;
(n) except as otherwise provided in dame (i), with respect
to dats$ submitted after December 31, 1969, by an applicant or
registrant to support an application for registration, experi-
mental use permit, or amendment adding a new use to an ex-
isting registration, to support or maintain in effect an existing
registration* or for reregutuauon, the Administrator may, with-
out das pennissioa of die original data submitter, consider any
such deni of data in suppou of an application by any other
person (hereinafter in tins sobparagraph referred to as the
"applicant") within the fifteen-year period following the date
the data were- originally submitted only if the applicant has
made an offer to cnrnprnme the original data- TOfr""B*r and
submitted such offer to the* A**m""s|niKif act'nmnanird by
evidence of delivery to the original data inrt""frfpr of the
offer. The terms and HIUUUIH of compensation may be fixed
by agreement between the original data submitter and the ap-
plicant, or, failing such agreement, binding arbitration under
this subparagraph. If, at the end of ninety days after the date
of delivery to the original data, submitter of the offer to com-
pensate; the original data submitter and the applicant have
neither agreed on the amount and terms of compensation nor
on a procedure for reaching an agreement on me amount and
terms of compensation, either person may initiate binding ar-
bitration proceedings by requesting the Federal Mediation and
Conciliation Service to appoint an arbitrator from the roster of
arbitrators maimaincrt by such Service. The procedure and
rules of the Service shall be applicable to the selection of
such arbitrator and to such arbitration proceedings, and the
findings and determination of the arbitrator thal1 be final and
conclusive, and no official or court of the United Slates shall
have power or jurisdiction to review any such findings and
determination, except for fraud, misrepresentation, or other
misconduct by one of the parties to the arbitration or die arbi-
trator where there is a verified complaint with supporting affi-
davits attesting to specific instances of such fraud, misrepre-
or other misconduct. The parties to the arbitration
.
shall share equally in the payment of the fee and expenses of
the arbitHHor. If die Af*""n*!nrtKFr ^fffliiiinet tf*yT an original
data, submitter has failed to participate in a procedure for
reaching an agreement or in an arbitration proceeding as re-
quired by this subparagraph, or failed to comply with the
terms of an agreement or arbitration decision concerning com-
pensation under this subparagraph, the original data submitter
shall forfeit the right to compensation for the use of the data
in support of the application. Notwithstanding any other pro-
vision of this Act, if the AHmini^tm^nr determines that an ap-
plicant has failed to participate in a procedure for reaching an
agreement or in an arbitration proceeding as required by this
Pesticides Inspection Manual 2-12 January 1989
-------
Chapter Two Pesticide Law and Definitions
IS _ FD-HA _ S*"Briitor may
rnn«irfgr such item of data in support of an application by any
other applicant without the permission of the original data
submitter and without an offer having been received to com-
pensate the original data submitter for the use of such item of
(E) the complete formula of the pesticide; and
(F) a request that the pestiuide be classified for general use for
restricted use, or for both.
(2) DATA IN SUPPORT OF REGISTRATION. —
(A) The Administrator shall publish guidelines specifying the
kinds of information which will be required to support the registra-
tion of a pesticide and shall revise such guidelines from time to
time. If thereafter he requires any additional kind of information
under subparagraph (B) of this paragraph, he shall permit sufficient
time for applicants to obtain such additional information. The Ad-
ministrator, in establishing standards for data requirements for the
registration of pesticides with respect to minor uses, shall make
such standards commensurate widi the anticipated extent of use,
pattern of use, and the level and degree of potential exposure of
man and the environment to the pesticide. In the development of
these standards, the Administrator shall consider the economic fac-
tors of potential national volume of use,- extent of distribution, and
the impact of the cost of meeting the requirements on the incen-
tives for any potential registrant to undertake the development of
the required data. Except as provided by section 10, within 30 days
after the Administrator registers a pesticide under this Act he shall
make available to the public the data called for in the registration
statement together with such other scientific information as he
deems relevant to his decision.
(B)(i) If the Administrator determines that additional data are re-
quired to maintain in effect an existing registration of a pesticide,
the Administrator shall notify all existing registrants of the pesti-
cide to which the determination relates and provide a list of such
registrants to any interested person.
Pesticides Inspection Manual 2-13 January 1989
-------
Chapter Two Pesticide Law and Definitions
S«C.3 BP3A 16
(ii) Each registrant of such pesticide shall provide evidence
within ninety days after receipt of notification that it is taking ap-
pnpriate steps to secure the additional data that are required. Two
ey agree and advise the Admin-
isnator of their intent within ninety days after notification. Any
registrant who agrees to share in the cost of producing the data
shall be fnriflH to examine and rely upon such data in support of
maintenance of such regisirarinn The Admimorator shall issue a
notice of intent to suspend die regisnatinn of a pesticide in accord-
ance wim the procedures prescribed by clause (iv) if a registrant
finis to comply with this clause.
(iii) If, at the end of sixty days after advising the Administrator
of dieir agreement to develop jointly, or share in die cost of devel-
oping data, the registrants have not further agreed on the terms of
the data development arrangement or on a procedure for reaching
such agreement any of such registrants may initiate binding arbi-
tration proceedings by requesting die Federal Mediation and Con-
ciliation Service to appoint an arbitrator from die rosier of arbitra-
tors maintained by such Service. The procedure and rules of the
Service shall be applicable to the selection of such arbitrator and to
such arbitration proceedings, ""4 die filings and n of
the arbitrator «haii be final and conclusive, and no official or court
of die United States shall have power or jurisdiction to review any
such findings and determination, except for fraud, misrepresenta-
tion, or other misconduct by one of die parties to die arbitration or
die arbitrator where there is a verified complaint with supporting
affidavits attesting to specific instances of such fraud, misrepresen-
tation, or other misconduct. All parties to the arbitration shall share
equally in the payment of die fee and expenses of die arbitrator.
The Administrator shall issue a notice of intent to suspend the reg-
istration of a pesticide in accordance with die procedures pre-
scribed by clause (iv) if a registrant oils to comply with this
clause.
(iy) Notwithstanding any other provision of this Act, if the Ad-
ministrator determines that a registrant, within die time required by
the AdmhiisBMor, has failed to take appropriate steps to secure the
data required tinder this subparagraph, to participate in a procedure
for reaching agreement concerning a joint data development ar-
mgemenc under this subparagraph or in an Arbitration proceeding
as required by this subparagraph, or to comply with die terms of
an agreement or atbitration decision concerning a joint data, devel-
opment arrangement under this subparagraph, the Administrator
may issue- a notice of intent to suspend such registrant's registra-
tion of die pesticide for which additional data is required. The Ad-
ministrator may include in die notice of intent to suspend such pro-
visions as the Administrator deems appropriate concerning the con-
tinued sale and USB of existing stocks of such pesticide. Any sus-
pension proposed under this subparagraph shall become final and
effective at die end of thirty days from receipt by die registrant of
tie notice of intent to suspend, unless during that time a request
for hearing is made by a person adversely affected by the notice or
tie registrant has satisfied the Administrator that die registrant has
Pesticides Inspection Manual 2^14January 1989
-------
Chapter Two Pesticide Law and Definitions
17 RfflA SlC.3
complied fully with die requirements that served as a basis for the
notice of intent to suspend. If a hearing is requested, a hearing
shall be conducted under section 6(d) of this Act The only matters
for resolution at that hearing shall be whether the registrant has
failed to ate the action that served as the basis for die notice of
intent to suspend the registration of the pesticide for which addi-
tional data is required, and whether the Administrator's determina-
tion with respect to the disposition of existing stocks is consistent
with this Act. If a bearing is held, a detisni after completion of
such hearing shall be final NbtwiihsttPdiug any ate provision of
this Act, a hearing skaU be held and a determination made within
seventy-five days after receipt of a- request for such hearing. Any
registration suspended under T*"T TOfrp"*griph shall be
by the Administrator if die Administrator determines chat the regis-
trant has complied fully with die requirements that served as a
basis for the suspension of die registration.
(v) Any data, submitted under this subparagraph shall be subject
to the provisions of paragraph (1XD). Whenever such data are sub-
mitted jointly by two or more registrants, an agent shall be agreed
on at die time of the joint submission to handle any subsequent
data compensation, matters for the joint submitters of such data.
(Q Within nine months after die date of enactment of this sub-
paragraph [Sepmber 30,1978], die Administrator shall, by regu-
lation, prescribe rimplifwA piuusduiea for die registration of pesti-
cides, which- shall include die provisions of subparagraph (D) of
this paragraph.
(D) EXHMPTIOH.—No applicant for registration of a pesticide
who proposes to purchase a registered pesticide from another pro-
ducer in order to formulate such purchased pesticide into the pesti-
cide that is the subject of the application " shall be required to—
(i) submit or cite data pertaining to such purchased produce
or
(ii) offer to pay reasonable compensation otherwise required
by paragraph (1XD) of this subsection for the use of any such
data.
(3) TIME FOR ACTING wrra RESPECT TO AWUCATION.—
(A) The Administrator shall review the data after receipt of the
application and shaft, as expeditiously as possible, euher register
die pesticide in accordance wuh paragraph (5), or notify die appli-
cant of his determination feat it does not comply with die provi-
sions of die Act in accordance with paragraph (6).
(BXO The Administrator shall, as expeditiously as possible,
review and act on any application received by die Administrator
that—
(I) proposes die initial or amended registration of an end-
use pesticide that, if registered as pioposed. would be identi-
cal or substantially similar in composition and labeling to a
currently-registered pesticide identified in the application, or
M Snoi 10Jn»inm* bjr cmkiat oat "• ad
-------
Chapter Two Pesticide Law and Definitions
S4C. 3 F1FBA 18
that would differ in composition and labeling from such cur-
rently-registered pesticide only in ways that would not signifi-
cantly increase the risk of unreasonable advene effects on the
environment; or
(D) piupojcs an amendmeat to the regnoiuon of a regis-
tered pesticide that does not require scientific review of data.
(H) In expediting the review of an application for an action de-
scribed in '•'<"'«»• (i), the AdninistRUor shall—
(I) within 45 days after receiving the application, notify the
FB^lStTBUt WQCfDBr OT OOt tDC 8DDUQC&OD IS COOlDlCtB flfld* U
the application is found to be incomplete, reject the applica-
tion;
(H) within 90 days after receiving; a complete application,
notify the registrant if tic application has been granted or
dtniffl* and
(HI) if the application is denied, notify the registrant in
writing of the specific reasons for the denial of the applica-
tion.
(4) Noras OF AHUCAITON.—The Administrator shall publish in the
Federal Register, promptly after receipt of the statemeu and other data
required pursuant to paragraphs (1) and (2), a. once 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 shall provide for
a period of 30 days in which any Federal agency or any other interested
person may comment.
(5) APPROVAL OF REOISTTUTION.—The Administrator shall register a
pesticide if be determines that, when considered with any restrictions
imposed under subsection (d>—
(A) its composition is such as to warrant the proposed claims for
it;
(B) its labeling and other material required to be submitted
comply with the requirements of this Ace
(Q it will perform its intended function without unreasonable
adverse effects on the environment; and
(D) when used in accordance with widespread and commonly
recognized practice it will not generally cause unreasonable ad-
verse effects on the environment
The AHmini^fyflifly fog|| not mn|f» any larlr of essentiality a criterion for
denying registration of any pesticide. Where two pesticides meet the re-
quirements of this paragraph, one should not be registered in preference
to the other. In considering an appticatrm for the registration of a pesti-
cide, the Administrator may waive A*p* requirements pertaining to effi-
cacy, in which event the Administrator may register die pesticide with-
out determining that the pesticide's composition is such ss to warrant
proposed claims of efficacy. If a pesticide is found to be efficacious by
any State under section 24(c) .of this Act, a presumption is established
that the Administrator shall waive data requirements pertaining to effi-
cacy for use of the pesticide in such Slate.
(6) DENIAL OF rEOisravnoN.—If the Administrator determines that
the requirements of paragraph (5) for registration are not satisfied, he
shall notify the applicant for registration of his determination and of his
reasons (including the factual basis) therefor, and that, unless the appli-
cant corrects the conditions and notifies the Administrator thereof
Pesticides Inspection Manual ~ 2^16January 1989
-------
Chapter Two Pesticide Law and Definitions
19 _ FtPRA _ StC.3
daring the 30-day period beginning with the day after the date on which
the applicant receives the notice, ihe Administrator may refuse to regis-
ter the pesticide. Whenever the Administrator refuses to register a pesti-
cide, he «h«ii notify the applicant of his ***r*ffl?" n*Ml of his reasons (in-
cluding the factual basis) dnefbr. Hie Adininhtiator shall promptly
publish in me Federal Register nonce of such denial of registration and
the reasons merefoc. Upon such notnVarion, the applicant for registra-
tion or other interested person with the coaamence of the applicant
shall have the same remedies as provided for in section 6.
(7) REGISTRATION UNDER SPECIAL ORCUMSTANCBS. — Notwithstanding
the provisions of paragraph (5}—
(A) The Admiinigffaror may conditionally register or amend the
registration of a pesticide if the Administrator determines that (0
the p»gif "<* and proposed uy*- are Mfnfiral or substantially
jo any currendy registered pesticide ind use thereof, or differ only
in ways that would not lignifiramly increase the risk of unreason-
able advene effects on the envunnmrnt, and (ii) approving the
registration or amendment in the i******** proposed by the applicant
would not significantly increase the risk of any unreasonable ad-
vene effect on the environment. An applicant seeking conditional
registration or amended registration under this subparagraph shall
SUJyim SQCft dfitft 8S WOtlid DO rftfllllTBO tO OOt&lD FBDStT&llOIl 01 &
similar pesticide under paragraph (5). If the applicant is unable to
submit an item of data becaue it has not yet been generated, the
Administrator may register or amend die registration of the pesti-
cide under such conditions as will require die submission of such
data not later dun the time such data are required to be submitted
wiu respect to similar pesticides already registered under this ACL
(B) The Administrator may conditionally amend the registration
of a pesticide to permit additional uses of such pesticide notwith-
standing that rfa*y concerning the pesticide may be insufficient to
ojppr>n 30 unconditional amendment, if the ArimjnjjBratnr deter-
mines that (i) the applicant has submitted satisfactory data pertain-
ing to the proposed additional use, and (ii) amending the registra-
tion in the manner proposed by the applicant would not significant-
ly increase the risk of any unreasonable advene effect on the envi-
ronment Notwithstanding the foregoing provisions of this subpara-
graph, no registration of a pesticide may be amended to permit an
additional use of such pesticide if die Administrator has issued a
notice stating that such p*tt"*'i1*. or any ingredient thereof, meets
or exceeds risk criteria associated in whole or in pan with human
dietary exposure enumerated in f*g"1***fT*w Mmxt mutfr thi< Act,
and during die pendency of any risk-benefit evaluation initiated by
such notice, if (I) die additional use of such pesticide involves a
major food or feed crop, or (II) the additional use of such pesticide
involves a minor food or feed crop and die Administrator deter-
mines, with die concurrence of die Secretary of Agriculture, there
is available an effective alternative pesticide dial does not meet or
exceed such risk criteria. An applicant seeking amended registra-
tion under this subparagraph shall submit such data as would be
required to obtain registration of a similar pesticide under para-
graph (5). If the applicant is unable to submit an item of data
(other dun data pertaining to die proposed additional use) because
Pesticides Inspection Manual 2-17 January 1989
-------
Chapter Two Pesticide Law and Definitions
SK.3 _ F1FRA _ 20
it has not yet been generated, the Administrator may amend the
registration under such conditions as will require the submission of
seek data not later than the time such data are required to be sub-
minxl with respect to similar pesticides already registered under
mis Act
(C) The A/4mmi«tratnr may «yjiriqn th*** by the ^nd of flirft period die
'
'receives such data and the data do not meet or exceed risk criteria
enumerated in regulations issued under this Act. and on such other
conditions as the Artmini^nitnr may prescribe. A conditional regis-
tration under this subparagraph shall be granted only if the Admin-
istrator determines that use of the pesticide during such period will
not cause any unreasonable adverse effect on die environment, and
met use of the pesticide is in the publk interest.
(8) INTERIM ADMINISTRATIVE REVIEW. — Notwithstanding any other
provision of this Act, the Administrator may not initiate a public inter-
im administrative itview pimeas to develop a risk-benefit evaluation of
die ingredients of a pesticide or any of its uses prior to initiating a
formal action to cancel, suspend; or deny registration of such pesticide,
required under this Act, unless such interim administrative process is
based on a validated test or other significant evidence raising prudent
concerns of unreasonable adverse risk to man or to the environment.
Notice of the definition of the terms "validated test" and "other signif-
icant evidence" as used herein «h"ii be published by the Administrator
in the Federal Register.
(d) CLASSIFICATION OF PESTICIDES. —
(1) CLASSIFICATION FOR GENERAL USB, RESTRICTED USE, OR BOTH. —
(A) As a part of die registration of a pesticide the Administrator
shall classify it as being for general use or for restricted use. If the
Administrator determines that some of die uses for which the pesti-
cide is registered should be for general use and that other uses for
which it is registered should be for restricted use, he shall classify
it for both general use and restricted use. Pesticide uses may be
by regulation on die »"«*"»i eiftaufifffupn snd registered
pesticides may be classified prior to reregjsaation. If some of die
uses of the pesticide are classified for general use and other uses
are classified for restricted use, die directions relating to its general
uses shall be clearly separated and distinguished from those direc-
tions relating to its restricted uses. The Administrator may require
that its packaging and labeling for restricted uses shall be clearly
distinguishable from its packaging and labeling for general uses.
(B) If the Administrator determines that die pesticide, when ap-
plied in accordance with its directions for use, warnings and cau-
tions and for the uses for which it is registered, cr for one or more
of such uses, or in accordance with a widespread and commonly
recognized practice, will not generally cause unreasonable adverse
effects on the environment, he will classify the pesticide, or the
Pesticides Inspection Manual 2^8 January 1989
-------
Chapter Two Pesticide Law and Definitions
21 JVRA 8*3
particular use or uses of the pesticide to which the determination
applies, for general use.
(C) If the Administrator determines >nar the pftticirtfti when ap-
plied in accordance with its directions for use, warnings and can*
lions and for the uses for which it is registered, or for one or more
of such uses, or in accordance with a widespread and commonly
recognized practice, may generally cause, without additional regu-
latory restrictions, unreasonable adverse effects on the environ-
ment, including injury to the applicator, he shall classify the pesti-
cide, or the particular use or uses to which the determination ap-
plies, for restricted use
(i) If the Administrator classifies a p»5tirv1*'1 or one or
more uses of snch pesticide, for restricted use because of a
ilfifiinmnrirm (hat the aGOB
-------
Chapter Twp Pesticide Law and Definitions
S«C. 4 RRA 22
single pesticide; and mfrl'Tiffwl names and lahgi* foaii be added to the regis-
by supplemental statements.
(0 MISCELLANEOUS. —
(1) Emcr OF CHANGS OF LABBUNO OR POEMULATON. — If the labeling
or funnuiauun for a pfffikKtc is r***"gfffi the registration shall be
amended to reflect such change if the ^<1fn'n'ffratf>r dctrrn1'1"^ '^"t the
change will not violate any provision of this Act.
(2) REGISTRATION NOT A DEPENSE.— In no event shall registration of
an article be construed as a defenfft for the fynminsam of any o£fense
under this ACL As long as no <^^rfh*««^ |f'f.ir*|'"g« an in effect reg-
istration of a pesticide shall be prima facie evidence that the pesticide,
its labeling, and packaging comply with the regisntion provisions of
the Act
(3) AUTHORITY TO CONSULT OTHER reunuL AGENCIES.— In connection
with considenttion of any registration or application for registration
under this section, the Administrator may consult with any other Feder-
al agency.
SEC 4. [13A] REREGISTRATION OF REGISTERED PESTICIDES.
(a) GENERAL RULE. — The Administrator shall reregister, in accordance
with this section, each registered pesticide containing any active ingredient
contained in any pesticide first registered before November 1, 1984, except
for any pesticide as to which the Administrator has determined, after No-
vember 1, 1984, and before the effective date of this section [December 24,
1988], that—
(1) there are no outstanding data requirements; and
(2) the requirements of section 3(c)(5) have been airisffcd,
(b) REREGISTRATION PHASES. — Reregistrations of pesticides under this sec-
tion shall be carried out in the following phases:
(1) The first phase shall include the listing under subsection (c) of
the active ingredients of the pesticides that will be reregistered.
(2) The second phase shall include the submission to the Administra-
tor under subsection (d) of notices by registrants respecting their inten-
tion to seek reregistration, identification by registrants of missing and
inadequate data for such pesticides, and commitments by registrants to
replace such tnctmig or inadequate d*** within the applicable rim*
period.
(3) The third phase «h«ii include submission to the Administrator by
registrants of the information required under subsection (e).
(4) The fourth phase shall include an independent, initial review by
the Administrator under subsection (0 of submissions under phases two
and three, identification of outstanding ***"* requirements, and the issu-
ance, as necessary, of requests for additional data.
(5) The fifth phase shall include the review by the Administrator
under subsection (g) of data submitted for reregistration and appropriate
regulatory action by the Administrator.
(c) PHASE ONE. —
(1) PRIORITY FOR REREOBTRATION.— For purposes of die reregistration
of the pesticides described in subsection (a), the Administrator shall list
the active ingredients of pesticides and shall give priority to, among
others, active ingredients (other than active ingredients for which regis-
tration standards have been issued before the effective date of this sec-
tion [December 24, 1988]) that—
Pesticides Inspection Manual 2-20 January 1989
-------
Chapter Two Pesticide Law and Definitions
23 _ RFHA _ S«C.4
(A) OK in use on or in food or feed and may result in posthar-
vest residues;
(B) may result in residues of potential lexicological concern in
potable ground water, edible fish, or «heiifi«h;
(C) have *HT determined by the Administrator before the effec-
tive date of dm section (December 24, 1988] to have significant
Qfltft IQQDIIC^DCBtS • Of
(D) are used oo craps, including in greenhouses and nurseries,
where worker exposure is most likely to occur.
(2) REREOBTRATION usrs. — For purposes of reregistration under this
DC A<|minivlrutnr ^hall Jjy order—
(A) not later than 70 days after the effective dale of this section
[December 24, 1988], list pesticide active ingredients for which
registration standards have been issued before such effective date;
(B) not later than 4 months after such effective date, list the first
150 pesticide active ingredients, as determined under paragraph
(D;
(Q not later than 7 months after such effective date, list the
second 150 pesticide active ingredients, as determined under para-
graph (1); and
(D) not later than 10 months after such effective date, list the
of the pesticide active 'ngp*rl"*nt51 as d^tff"1'"^ under
paragraph (1).
Each list shall be published in the Federal Register.
(3) JUDICIAL REVIEW. — The content of a list issued by the Administra-
tor under paragraph (2) shall not be subject to judicial review.
(4) NOTICE TO REGISTRANTS. — On the publication of a list of pesticide
active ingredients under paragraph (2), the Administrator shall send by
certified mail to the registrants of the pesticides containing such active
ingredients a notice of the time by which the registrants are to notify
the Administrator under subsection (d) whether die registrants intend to
seek or not to seek reregistration of such pesticides.
(d) PHASE Two. —
(1) IN GENERAL. — The registrant of a pesticide that contains an active
ingredient listed under subparagraph (B), (Q, or (D) of subsection
(c)(2) shall submit to the Administrator, within the time period pre-
scribed by paragraph (4), the notice described in paragraph (2) and any
information, commitment, or offer described in paragraph (3).
(2) NOTICE OP INTENT TO SEEK OR NOT TO SEEK REREGISTRATION. —
(A) The registrant of a pesticide containing an active ingredient
listed under subparagraph (B), (Q, or (D) of subsection (c)(2) shall
notify the Administrator by certified mail whether the registrant in-
tends to seek or does not intend to seek reregistration of the pesti-
cide.
(B) If a registrant submits a notice under subparagraph (A) of an
intention not to seek reregistration of a pesticide, the Administrator
shall publish a notice in the Federal Register stating that such a
notice has been submitted.
(3) MISSING OR INADEQUATE DATA. — Each registrant of a pesticide
that contains an active ingredient listed under subparagraph (B), (Q, or
(D) of subsection (c)(2) and for which the registrant submitted a notice
under paragraph (2) of an intention to seek reregistration of such pesti-
cide shall submit to the Administrator---
Pesticides Inspection Manual 2-21 January 1989
-------
Chapter Two Pesticide Law and Definitions
See. 4 F1FRA 24
(A) in accordance with regulations issued by the Administrator
jw section 3, an identification of—
(i) all data that are required by regulation to support the
registration of the pesticide with respect to such active ingre-
dient;
(ii) data that were submitted by the registrant previously in
support of the registration of the pesticide that are inadequate
to meet such regulations; and
(m) data identified under clause (0 that have not been sub*
fpfrff^j to (he Administrator; and
(B) either—
(i) a ^QTitP't1"**1* to fif*pr* tfaff data identified unrtfr sub-
paragraph (AXii) and submit the data "<*«ttfiH under sub-
aph (AXiii) within me applicable tone period prescribed
by paragraph (4XB); or
(ii) an offer to share in the cost to be incurred by a person
who has made a commitment under clause (i) to replace or
submit the data and an offer to submit to arbitration as de-
scribed by section 3(cX2)(B) with regard to such cost sharing.
For purposes of a submission by a registrant under subparagraph
(A)(ii), data are inadequate if the data are derived from a study with
respect to which the registrant is unable to make the certification pre-
scribed by subsection (eXIXG) that the registrant possesses or has
access to the raw data used in or generated by such study. For purposes
of a submission by a registrant under such subparagraph, data shall be
considered to be inadequate if the data are derived from a study submit-
ted before January 1, 1970, unless it is demonstrated to the satisfaction
of the Administrator that such data, should be considered to support the
registration of the pesticide that is to be reregistered.
(4) TIME PERIODS.—
(A) A submission under paragraph (2) or (3) shall be made—
(i) in the case of a pesticide containing an active ingredient
listed under subsection (cX2)(B), not later than 3 months after
the date of publication of the listing of such active ingredient;
(ii) in the case of a pesticide containing an active ingredient
listed under subsection (cX2XO, not later than 3 months after
the date of publication of the listing of such active ingredienq
and
(iii) in the case of a pesticide containing an active ingredi-
ent listed under subsection (cX2XD), not later than 3 months
after the date of publication of the listing of such active ingre-
dient
On application, the Administrator may extend a; tune period pre-
scribed by 'h** subparagraph if the Administrator determines that
factors beyond the control of the registrant prevent the registrant
from complying with such period.
(B) A registrant shall submit data in accordance with a commit-
ment entered into under paragraph (3XB) within a reasonable
period of time, as determined by the Administrator, but not more
than 48 months after the fore the registrant submitted the commit-
ment. The Administrator, on application of a registrant, may
extend the period prescribed by the preceding sentence by no more
than 2 years if extraordinary circumstances beyond the control of
Pesticides Inspection Manual 2^22~ January 1989
-------
Chapter Two Pesticide Law and Definitions
25 HFRA S4C.4
(be registrant prevent the registrant from submitting data within
SQCu DPC9C^10Cu DCX1QQ*
(5) CANCELLATION AND REMOVAL.—
(A) If ihe legisuaat of a pesticide does not submit a notice
•nder pnagraph (2) or (3) within the time prescribed by paragraph
(4XA), the Administrator shall issue a notice of ontent to cancel the
registration of such registrant for such pesticide and shall publish
the notice in the Federal Register and allow 60 days for the sub-
mission of comments on the notice. On expiration of such 60 days,
me Administrator, by order and without a hearing, may cancel the
registration or take such other action, including extension of appli-
cable time periods, as may be necessary to enable reregistraaon of
such pesticide by another person.
(BXO If-
(I) no registrant of a pesticide containing an active ingredi-
ent listed under subsection (c)(2) notifies the Administrator
under paragraph (2) that the registrant intends to seek reregis-
tration of any pesticide containing that active ingredient;
(II) no such registrant complies with paragraph (3KA); or
(ill) no such registrant «""»« a commitment under para-
graph (3XB) to replace or submit all data described in clauses
(ii) and (iii) of paragraph (3)(A);
the AHminiffl-fltflf shall publish in the Federal Register a notiff of
intent to remove the active ingredient from the list ffflMfchrrl
under subsection (cX2) and a notice of intent to cancel the registra-
tions of all p*?***^*? containing 5wh active ingredient and
-------
Chapter Two Pesticide Law and Definitions
Stt. 4 RFRA 28
accordance with the guidelines issued under paragraph (4), to the
Administrator—
(A) a summary of each study concerning the active ingredient
previously submitted by the registrant m luipput of the registration
of a pesticide containing such active ingredient and considered by
the registrant to be adequate to meet the requirements of section 3
and the "»g«»iaHon? issued under such section;
(B) a summary of each study concerning the active ingredient
previously y^ifrinitTKt oy toe 2C2is&9Dt in suppovi or tnc rcsisor&oon
of a pesticide containing such active ingredient that may not
comply with the requirements of section 3 and the regulations
issued under such miiuu but which die ||en'!Hm** asserts should be
deemed to comply with such requirements and regulations;
(Q a reformat of the data from each study gimmanred under
snbpaiagraph (A) or (B) by die registrant concerning chronic
dosing, oncogenicity, reproductive effects, mungenicity, neurotpxi-
dty, tentogenitity, or residue chemistry of the active ingredient
that were submitted to the Administrator before January 1, 1982;
(D) where data described in snbpangraph (Q are not required
for the active ingredient by regulations issued under section 3, a
reformat of acute and subchronic dosing data submitted by the reg-
istrant to the Administrator before January 1, 1982, that the regis-
trant considers to be adequate to meet the requirements of section-
3 and the regulations issued under such section;
(E) an irfMniffcatx?" of dat* ^t are required to be submitted to
the Administrator under section 6(aX2) indicating an adverse effect
of die pesticide;
(F) an 'dfftificatiiTn of any odier information available that in
the view of the registrant supports the registration;
(G) a. certification thar the registrant or the Administrator pos-
sesses or has access to the raw data used in or generated by the
studies that the icgisuaia summarized under subparagraph (A) or
(B);
(H) either-
(i) a commitment to submit data to Mil each outstanding
data requirement idfnrifigd by die registrant; or
(ii) an offer to share in die cost of developing such data to
be incurred by a person who has made a commitment under
clause (i) to submit such data, and an offer to submit to arbi-
tration as described by section 3(cX2XB) wim regard to such
cost sharing; and
(I) evidence of compliance with section 3(c)(lXDX"u) and regu-
lations issued thereunder with regard to previously submitted data
as if the registrant were now seeking the original registration of the
pesticide.
A registrant who submits a certification under subparagraph (G) that is
false shall be considered to have violated this Act and shall be subject
to the penalties prescribed by section 14.
(2) TIME PERIODS.—
(A) The information required by paragraph (1) shall be submit-
ted to the Administrator—
(i) in the case of a pesticide containing an active ingredient
listed under subsection (cX2)(B). not later than 12 months
Pesticides Inspection Manual 2^4 January 1989
-------
Chapter Two Pesticide Law and Definitions
27 _FiFRA 8*6.4
after the date of publication of the listing of such active ingre-
dient;
(ii) in the cay of a pesticide containing an active ingredient
listed under subseoinn (cX2XQ. not later than 12 months
after die 4ai* of publication of the listing of such active ingre-
dient; and
(iii) in the ngf of a pesticide containing an active ingredi-
ent listed under snbsectkm (cX2)(D), not later than 12 months
after the date of publication of the listing, of such active ingre-
dient.
(B) A regisuant shall submit data in '"•"Har* with a commit-
ment entered into under paragraph (1XH) within a reasonable
period of time, as determined by the Administrator, but not more
thyi 48 months after the datn the regisnnt mitunittfld the commit-
ment under such paragraph. The Administrator, on application of a
registrant, may extend me period prescribed by the preceding sen-
tence by no more ^"p 2 years if extraordinary circumstances
beyond the control of the registrant prevent the registrant from
soQUuttuiff odtft within such prescribed ncnod»
(3) CANCELLATION.—
(A) If the registrant of a pesticide fails to submit the information
required by paragraph (1) widiin the dine prescribed by paragraph
(2), the Administrator, by order and without hearing, shall cancel
the registration of such pesticide.
(BXO If the registrant of a pesticide submits die information re-
quired by paragraph (1) within die time prescribed by paragraph
(2) and such information does not conform to the guidelines for
submissions "sfflfrUs*"*! by the Administrator, the Administrator
shall determine whether the registrant made a good faith attempt to
conform its submission to such guidelines.
(ii) If the Adfifflstrato1* determines that the registrant made a
good faith attempt to conform its submission to such guidelines,
the Administrator shall provide the registrant a reasonable period
of time to make any necessary changes or corrections.
(iiiXD If the Administrator determines that the registrant did not
make a good faith attempt to conform its submission to such
guidelines, the Administrator may issue a notice of intent to cancel
the registration. Such a notice shall be sent to the registrant by cer-
tified mail.
(II) The registration shall be canceled without a bearing or far-
mer notice at the end of 30 days after receipt by the registrant of
the notice unless during mat time a request for a bearing is ?r »ne
by the registrant.
(HI) If a hearing is requested, a hearing shall be conducted
under section 6(d), except that die only matter for resolution at the
bearing shall be whether the registrant made a good faith attempt
to conform its submission to such guidelines. The hearing shall be
held and a determination made widiin 75 days after receipt of a
request for hearing.
(4) GUIDELINES.—
(A) Not later than 1 year after the effective date of this section
[December 24, 1988], the Administrator, by order, snail issue
guidelines to be followed by registrants in—
Pesticides Inspection Manual 2-25 January 1989
-------
Chapter Two Pesticide Law and Definitions
StC.4 RFHA 28
(0
(ii) reformatting studies;
(ni) identifying advene inf
that may not meet the requirements of section 3 or regulations
issued under such section,
*Q).
(B) Guidelines issned under subparagraph (A) shall not be sub-
ject to judicial review.
(5) MoNrrauNa—The Administrator shall monitor the progress of
T6IDStE-
(i) in the case of a pesticide containing an active ingredient
listed vmdfr subsection (c)(2)(B), not later than 18 months
after the date of die listing of such active ingredient;
(ii) in the case of a pesticide containing an active ingredient
listed under subsection (cX2)(Q, not later titan 24 months
after the date of die listing of such active ingredient; and
(iii) in the case of a pesticide containing an active ingredi-
ent listed "inter subsection (c)(2XD), not \*trr than 33 months
after die date of die listing of such active ingredient.
(B) If die Administrator issues a notice to a registrant under
paragraph (1KB) for die submission of additional data, die regis-
trant shall submit such data widiin a reasonable period of time, as
determined by the Administrator, but not to exceed 48 months
after die issuance of such notice. The Administrator, on application
of a registrant, may extend die period prescribed by the preceding
sentence by no more than 2 yean if extraordinary circumstances
beyond die control of die registrant prevent the registrant from
submitting data within such prescribed period.
Pesticides Inspection Manual 2-26 January 1989
-------
Chapter Two Pesticide Law and Definitions
29 RfflA SiC.4
(3)*-i SUSPENSIONS AND PENALTIES.—The Administrator
shall issue a notice of intent to suspend the registration of a
pemridft in accordance with the procedures prescribed by sec-
ban 3(cX2XBXiv) if the Adminisntor determmes that (A)
ff^M necessary to fin an outstanding **•*• requirement for such
pesticide have not been initiated within 1 year after the issu-
ance of a notice under paragraph (1KB), or (B) progress is in-
sufficient to ensure submission of the ****WBtflT "tv»n
obtain any needed product-specific data regarding the pesticide by
use of section 3(cX2XB) and shall review such data within 90 days
after its submission. The ^f*m'pi!Brafnr «h*n require that ^f
under thi$ subparagraph be submitted to the Administrator not laty
than 8 months after a determination of eligibility under subpara-
graph (A) has been made for each active ingredient of the peso-
ode, unless the Adrp'niiBrator determines *h*>* a longer period is
required for the generation of the data.
(Q After conducting the review required by paragraph (1) for
each active ingredient of a pesticide and the review required by
subparagraph (B) of this paragraph, the Administrator shall deter-
mine whether to reregister a pesticide by determining whether such
pesticide meets the requirements of section 3(c)(5). If the Adminis-
trator determines that a pesticide is eligible to be reregistered, the
Administrator «h»n reregister such pesticide within 6 months after
the submission of the data concerning such pesticide under sub-
paragraph (B).
(D) If after conducting a review under paragraph (1) or subpara-
graph (B) of this paragraph the Administrator determines that a
pesticide should not be reregistered, the Administrator shall take
appropriate regulatory action.
(h) COMPENSATION OP DATA SUBMITTER.—If data that are submitted by a
registrant under subsection (d), (e), (0, or (g) are used to support the appli-
cation of another person under section 3, the registrant who submitted such
data shall be entitled to compensation for the use of such data as prescribed
by section 3(c)(l)(D). In determining the amount of such compensation, the
fees paid by the registrant under this section shall be taken into account.
Mafia of pm^tfh (3) «hould b* tU*wd with mnpn cf pradinf pntfin* (2).
Pesticides Inspection Manual 2-27 January 1989
-------
Chapter Two Pesticide Law and Definitions
S«C.4 RFRA 30
(0 FEES.—
(1) INITIAL FEE FOR POOD OR RED USB PESTTODE ACTIVE INGREDI-
ENTS.—The registrants of pesticides that contain an active ingredient
that is listed under subpmayaph (B), (Q, or (D) of subsection (cX2)
and duk i* aa active higmriirnt of my pesticide registered for a major
food or feed use shall collectively pay a fee of $50,000 on submission
of information under paragraphs (2) and (3) of subsection (d) for such
ingredient.
(2) FINAL FEE FOR POOD OR FEED USE mnoDB ACTIVE INGREDIENTS.—
(A) The registrants of pesticides that contain an active ingredient
that is listed under subparagraph (B), (Q, or (D) of subsection
(cX2) and that is an active ingredient of any pesticide registered
for a major food or feed use shall collectively pay a fee of
$100.000—
(0 on submission of information for such ingredient under
subsection (eXl) if data are reformatted under subsection
(eXlXQ:or
(ii) on submission of data, for such ingredient u"d*r subsec-
tion (eX2XB) if data are not reformatted under subsection
(eXlXQ.
(B) The registrants of pesticides mat contain an active ingredient
thai is listed, under subsection (cX2)(A) and that is an active ingre-
dient of any pesticide registered for a major food or feed use shall
collectively pay a fee of $150,000 at such time as the Administra-
tor shall prestiibe.
(3) FEES FOR OTHER PESTICIDE ACTIVE INGREDIENTS.—
(A) The registrants of pesticides that contain an active ingredient
that is listed under subparagraph (B), (Q, or (D) of subsection
(cX2) and that is not an active ingredient of any pesticide regis-
tered for a major food or feed use shall collectively pay fees in
amounts determined by the Administrator. Such fees may not be
less than one-half of, nor greater than, the fees required by para-
graphs (1) and (2). A registrant shall pay such fees at the times
corresponding to the times fees prescribed by paragraphs (1) and
(2) are to be paid.
(B) The registrants of pesticides that contain an active ingredient
that is listed under subsection (c)(2XA) and that is not an active
ingredient of any pesticide that is registered for a major food or
feed use shall collectively pay a fee of not more than $100,000
and not less than $50,000 at such time as the Administrator shall
prescribe.
(4) REDUCTION OR WAIVER OP FEES FOR MINOR USE AMD OTHER PESTI-
CIDES.—
(A) An active ingredient that is contained only in pesticides that
are registered solely for agricultural or nonagricultural minor uses,
or a pesticide the value or volume of use of which is small, shall
be exempt from the fees prescribed by paragraph (3).
(B) An antimicrobial active ingredient, the production level of
which does not exceed 1,000,000 pounds per year, shall be exempt
from the fees prescribed by paragraph (3). For purposes of this
subparagraph, the term "antimicrobial active ingredient" means
any active ingredient that is contained only in pesticides that are
not registered for any food or feed use and that i
Pesticides Inspection Manual 2^28 January 1989
-------
Chapter Two Pesticide Law and Definitions
31 RFHA StC.4
(i) sanitizers intended to reduce the number of living bacte-
ria or viable virus particles on inanimate surface or in water
or air;
(ii) bactehostats intended to inhibit the growth of bacteria
in the presence of moisture;
(o"i) disinfectants intended to destroy or irreversibly inacti-
vate H»« tm ia fungi, or viruses on surfaces or inanimate ob-
jects;
(iv) sterilizers intended to destroy viruses and all living
PflCtfffBLi lU&Ki* 8PO tfaffir SPOfCS OQ UUUUOUttC SQTIdCCS* OT
(v) fungicides or fungi starc
(CXO Notwithstanding any other provision of this subsection, in
the case of a small business registrant of a pesticide, the registrant
shall pay a fee for the reregistration of each active ingredient of
the pesticide that does not exceed an amount determined in accord-
ance with this subparagraph.
(ii) If during the 3-year period prior to reregistration the average
annual gross revenue of the registrant from pfsticidfs containing
such active ingredient is—
(I) less than $5,000,000, the registrant shall pay OJ percent
of such revenue;
(II) 55,000,000 or more but less than $10,000,000, the reg-
istrant shall pay 1 percent of such revenue; or
(HI) $10,000,000 or more, the registrant shall pay 1.5 per-
cent of such revenue, but not more than $150,000.
(iii) For the purpose of this subparagraph, a small business reg-
istrant is a corporation, partnership, or unincorporated business
that.—
(I) has 150 or fewer employees; and
(II) during the 3-year period prior to reregistration, had an
average annual gross revenue from chemicals that did not
exceed $40,000,000.
(5) MAINTENANCE FEB.—
(A) Subject to other provisions of this paragraph, each registrant
of a pesticide shall pay an annual fee by March 1 of each year
of—
(0 in the case of a registrant holding not more than 50 pes-
ticide registrations, $425 for each registration; and
(ii) in the case of a registrant holding more than 50 pesti-
cide registrations—
(I) $425 for each registration up to 50 registrations;
and
(II) $100 for each registration over 50 registrations,
except that no fee shall be charged for more than 200
registrations held by tiny registrant
(B) The amount of each fee prescribed under subparagraph (A)
shall be adjusted by the Administrator to a level that will result in
the collection under this paragraph of, to the extent practicable, an
aggregate amount of $14,000,000 each fiscal year.
(Q(i) The maximum annual fee payable by a registrant under
clause (i) of subparagraph (A) (as adjusted under subparagraph
(B)) shall be $20,000.
Pesticides Inspection Manual 2-29 January 1989
-------
Chapter Two Pesticide Law and Definitions
S4C.4 HFHA 32
(ii) The maximum annual fee payable by a registrant under
clause (ii) of subparagraph (A) (as adjusted under subparagraph
(B)) shall be $35,000.
0) If aqr fee prescribed by mis paragraph with respect to die
registration of a* pesondB it not pwi by a registrant by the tune
prescribed, the Administrator, by order aad without bearing, may
fjjnffii the registration.
(E) The authority provided under this paragraph shall terminate
on September 30,1997.
(6) OTHER FEES.—During die period beginning on die date of enact-
ment of this section [October 25, 1988] and ending on September 30,
1997, die Administrator may not levy any odier fees for die registration
of a pesticide under this Act except as provided in paragraphs (1)
through (5).
(7) APPORTIONMENT.—
(A) If two or more registrants are required to pay any fee pre-
scribed by paragraph (1), (2), or (3) with respect to a particular
active ingredient, the fees for such active ingredient shall be appor-
tioned among such registrants on the basis of the market share in
United Slates sales of the active ingredient for die 3 calendar years
preceding the date of payment of such fee, except that—
(i) small business registrants that produce the active ingre-
dient shall pay fees in accordance with paragraph (4XQ; and
(ii) registrants who have no market share but who choose to
reregister a pesticide containing such active ingredient shall
pay the lesser of—
(I) 15 percent of die reregistranon fee; or
(II) a proportionate amount of such fee based on die
lowest percentage market share held by any registrant
active in die marketplace.
In no event shall registrants who have no market share but
who choose to reregister a pesticide containing such active in-
gredient collectively pay more dun 25 percent of die total
active ingredient reregisoation fee.
(B) The Administrator, by order, may require any registrant to
submit such reports as the Administrator determines to be neces-
sary to allow die Administrator to determine and apportion fees
under this subsection or to determine die registrant's eligibility for
a reduction or waiver of a fee.
(Q If any such report is not submitted by a registrant after re-
ceiving notice of such repon requirement, or if any fee prescribed
by this subsection (odier than paragraph (5)) for an active ingredi-
ent is not paid by a registrant to die Administrator by die time pre-
scribed under this subsection, die Administrator, by order and
without hearing, may cancel each registration held by such regis-
trant of a pesticide containing the active ingredient with respect to
which the fee is imposed. The Administrator shall reapportion die
fee among the remaining registrants and notify die registrants that
die registrants are required to pay to die Administrator any unpaid
balance of die fee within 30 days after receipt of such notice.
(j) EXEMPTION OF CERTAIN REGISTRANTS.—The requirements of subsec-
tions (d), (e), (0. and (i) (odier than subsection 0X5)) regarding data con-
cerning an active ingredient and fees for review of such data shall not apply
Pesticides Inspection Manual 2^30January 1989
-------
Chapter Two Pesticide Law and Definitions
33 FffRA S«C.S
to any person who is the registrant of a pesticide to the extent that, under
section 3(cX2XD), the person would not be required to submit or cite such
data to obtain an initial registration of such pesticide.
(k) REHKBSTRATION AND EXPEDITED PfcOCTSSDW FOND.—
(1) EsTABLBHMBNT.—There shall be established in the Treasury of
the United States a reregistration and expedited processing fund.
(2) SOURCE AND USB.—All fees collected by the Administrator under
subsection (i) shall be deposited into the fund and shall be available to
the AHminig^mtnr without fiscal year limitation, to carry out reregistra-
QjQQ flQu CXDOCDlDu UOCCSS^QJC Qi HUBUflf SDDUC&fiOOS*
(3) EXPEDTIED PROCESSING OF SttOLAK AIHJCATJDNS.—
(A) The Administrator shall use each fiscal year not more than
$2,000,000 of the amounts in the fond to obtain «"fli"«* person-
nel and resources ID amin. the expedited processing •**** review of
any application that—
(i) proposes the initial or amended registration of an end-
use pesticide that, if registered as proposed, would be identi-
cal or fflfronnriany «imiinr jn composition and i*h*>J«"g to a
currently-registered pesticide identified in the applicatioa, or
that would differ in composition and labeling from any such
currently-registered pesticide only in ways that would not sig-
nificantly increase the risk of unreasonable adverse effects on
the environment; or
(ii) proposes an amendment to the registration of a regis-
tered pesticide that does not require scientific review of data.
(B) Any amounts made available under subparagraph (A) shall
be used to obtain sufficient personnel and resources to carry out
the activities described in such subparagraph that are in addition to
the personnel and resources available to carry out such activities
on the date of enactment of this section (October 25,1988].
(4) UNUSED FUNDS.—Money in the fund not currently needed to carry
out this section shall be—
(A) maintained on hand or on deposit;
(B) invested in obligations of the United States or guaranteed
thereby; or
(C) invested in obligations, participations, or other instruments
that are lawful investments for fiduciary, trust, or public funds.
(5) ACCOUNTING.—The Administrator shall—
(A) provide an annual accounting of the fees collected and dis-
bursed from the fund; and
(B) take all steps necessary to ensure diat expenditures from
such fund are used only to carry out this section.
(0 JUDICIAL REVIEW.—Any failure of the Administrator to take any action
required by this section shall be subject to judicial review under the proce-
dures prescribed by section 16(b).
SEC 5. [13tfe] EXPERIMENTAL USE PERMITS.
(a) ISSUANCE.—Any person may apply to the Administrator for an experi-
mental use permit for a pesticide. The Administrator shall review the appli-
cation. After completion of the review, but not later than one hundred and
twenty days after receipt of the application and all required supporting data,
the Administrator shall either issue the permit or notify the applicant of the
Administrator's determination not to issue the permit and the reasons there-
for. The applicant may correct the application or request a waiver of the
Pesticides Inspection Manual 2-31 January 1989
-------
Chapter Two Pesticide Law and Definitions
S«C.6 F1FRA 34
conditions far such permit within thirty days of receipt by the applicant of
such notification. The Am are '"»^^7"«» to avoid 'iTflronflNf ad-
verse effects on the environment
(0 STATE ISSUANCE OP PERMITS.—Notwithstanding die foregoing provi-
sions of mis section, the Administrator shall, under such terms and condi-
tions as he may by regulations prescribe, authorize any State to issue an ex-
perimental use permit for a pesticide. All provisions of section 11 relating to
State plans shall apply with equal force to a State plan for the issuance of
experimental use permits under this section.
(g) EXEMPTION FOR AGRICULTURAL RESEARCH AGENOES.—Notwithstanding
the foregoing provisions of this section, the Administrator may issue an ex-
perimental use permit for a pesticide to any public or private agricultural
research agency or educational institution which applies for such permit
Each permit shall not exceed more than a one-year period or such other spe-
cific time as the Administrator may prescribe. Such permit shall be issued
under such terms and conditions restricting the use of die pesticide as the
Administrator may require. Such pesticide may be used only by such re-
search agency or educational institution for purposes of experimentation.
SEC 6. [13M] ADMINISTRATIVE REVIEW; SUSPENSION.
(a) CANCELLATION AFTER FIVE YEARS—
(1) PROCEDURE.—The Administrator shall cancel die registration of
any pesticide at die end of die five-year period which begins on die
date of its registration (or at die end of arty five-year period thereafter)
unless die registrant, or other interested person with the concurrence of
die registrant, before the end of such period, requests in accordance
with regulations prescribed by the Administrator that die registration be
continued in effecL The Administrator may permit the continued sale
and use of existing stocks of a pesticide whose registration is canceled
under this subsection or subsection (b) to such extent, under such con-
ditions, and for such uses as he may specify if he determines that such
sale or use is not inconsistent with the purposes of this Act and will not
Pesticides Inspection Manual 2-32 January 1989
-------
Chapter Two Pesticide Law and Definitions
35 _ _RFRA _ S«C.6
have unreasonable adverse effects on the environment. The Administra-
tor shall publish m the Fedeot Register, at least 30 days prior to the
expiration of such five-year period, notice that the registration will be
cancel rd if tnerepsnant or other interested person with the concurrence
of the registrant does not request that the registration be continued in
effect
(2) INFORMATION. — If at any time after the registration of a pesticide
the registrant has w1
-------
Chapter Two Pesticide Law and Definitions
Sec. 6 BFRA 36
In taking any fi"»i action under ***** subsection, the ^"""'fffflttrr shall con-
sider restricting a pesticide's use or uses as an alternative to cancellation and
shall fully explain the reasons for thcac restrictions, and shall ""MwM'- among
those factors to be *•*"*» into w^ir't t**f- irppict of jwh final •*•*""« on pro*
duction and prices of agricultural TnmmfKl'f'*Ti retail food prices, fl"^ otfaer-
wise on the agricultural economy, and be shall publish in the Federal Regis-
ter an analysis of such impact.
(c) SUSPENSION. —
(1) OBDHL— If the Administrator determines thnt action is necessary
to prevent an imminent hazard during the time required for cancellation
or change in Hayifimtinn ••••••Miing* tttt may, by order, suspend the
registration of the pesticide immediately. No order of suspension may
be 'fwMl ""iftt thf- Administrator fa** i^ifd or at tfcg same time 'ynws
notice of his intention to nir*^ the registration of change the <*in«ifica-
tion of the pesticide. Except as provided in paragraph (3), the Adminis-
trator shall notify the registrant prior to issuing any suspension order.
Such notice shall include findings pertaining to (he question of "immi-
nent hazard". The registrant shall men have an opponunity, in accord-
ance with the provisions of paragraph (2), for an Mpditmi hearing
before the A/1""n'stratfff on the question of whether an imminent
hazard exists.
(2) EXPEDITE HEARING. — If no request for a bearing is submitted to
the Administrator within five days of the registrant's receipt of the noti-
fication provided for by taiagiaph (1), the suspension order may be
issued and shall take effect and shall not be reviewabte by a court If a
hearing is requested, it shall commence within five days of the receipt
of the request for such hearing unless the registrant and the Administra-
tor agree that it shall commence at a later time. The bearing shall be
held in accordance with the provisions of subchapter n of title 5 of the
United Suites Code, except that the presiding officer need not be a cer-
tified hearing examiner. The presiding officer shall have ten days from
the conclusion of the presentation of evidence to submit recommended
findings and conclusions to the Administrator, who shall then have
seven days to render a final order on the issue of suspension.
(3) EMERGENCY ORDER. — Whenever the Administrator determines that
an emergency exists that does not permit him to hold a hearing before
suspending, he may issue a suspension order in advance of notification
to the registrant In that case, paragraph (2) shall apply except that (A)
the order of suspension shall be in effect pending die expeditious com-
pletion of the remedies provided by dm paragraph and die issuance of
a final order on suspension, and (B) no party other than the registrant
and die Administrator shall participate except that any person adversely
affected may file briefs within die time allotted by the Administrator's
rules. Any person so filing briefs shall be considered a party to such
proceeding for die purposes of section 16(b).
(4) JUDICIAL REVIEW.— A final order on die question of suspension
following a hearing shall be reviewable in accordance with Section 16
of this Act notwithstanding the fact mat any related cancellation pro-
ceedings have not been completed. Any order of suspension entered
prior to a hearing before the Administrator shall be subject to immedi-
ate review in an action by the registrant or other interested person with
the concurrence of die registrant in an appropriate district court solely
to determine whether the order of suspension was arbitrary, capricious
Pesticides Inspection Manual 2-34 January 1989
-------
Chapter Two Pesticide Law and Definitions
37 FTFgA S4C.6
or an abuse of discretion, or whether the order was issued in accord*
ance with the procedures established by law. The effect of any order of
the coon will be only to stay the effectiveness of the suspension order,
ffftufna rtm AHminiqratnr'« final ijvri^ifm Wldl fMPffl tO Cancellation
or change in *'••""'""^ This action may be mamnrinrd simulia-
neously with any «h«ii»t«ii«iii«a review proceeding under this section.
The commencement of proceedings under this paragraph shall not oper-
ate as a stay of order, unless ordered by the coon.
(d) PUBLIC HEARINGS AND SCIENTIFIC: REVIEW.—In me event a bearing is
rpqof^tfd |*untimiit (o subsection (b) or determined upon by the Administra-
tor pursuant to subsection (b), such heating shall be held after due notice for
the purpose of receiving evidence relevant and material to die issues raised
by the objections filed by the applicant or other interested parties, or to the
issues stated by die Administrator, if the hearing is called by the Administra-
tor rather than by the filing of objections. Upon a showing of relevance and
reasonable scope of evidence sought by any party to a public hearing, the
Hearing Examiner shall issue a subpera to compel testimony or production
of documents from any person. The Hearing Examiner shall be guided by
the principles of the Federal Rules of Civil Procedure in making any order
for the protection of the witness or the content of d"rw**"ff produced and
shall order the payment of rratmsMt, fees and expenses as a condition to
requiring testimony of die witness. On contest, the subpena may be enforced
by an appropriate United States district court in accordance with die princi-
ples stated herein. Upon the request of any party to a public hearing and
when in the Hearing Examiner's judgment it is necessary or desirable, the
Hearing Examiner shall at any time before die hearing record is closed refer
to a. Committee of die National Academy of Sciences the relevant questions
of scientific fact involved in die public hearing. No member of any commit-
tee of die National Academy of Sciences established to carry out the func-
tions of this section shall have a financial or other conflict of interest with
respect to any matter considered by such ^yminfg. The Committee of the
National Academy of Sciences shall report in writing to die Hearing Exam-
iner within 60 days after such referral on these questions of scientific fact.
The report shall be made public and shall be considered as pan of the hear-
ing record. The Administrator shall enter into appropriate arrangements with
die National Academy of Sciences to assure an objective and competent sci-
entific review of the questions presented to Committees of the Academy and
to provide such other scientific advisory services as may be required by the
Administrator for carrying out die purposes of diis Act As soon as practica-
ble after completion of die bearing (including the report of die Academy)
but not later than 90 days thereafter, the Administrator shall evaluate die
data and reports before him and issue an order either revoking his notice of
intention isM**f pursuant to ****« trrTron. or «h»n 'ssw an order either canccl-
ing the registration, changing die classification, denying die registration, or
requiring modification of the labeling or packaging of die article. Such order
shall be based only on substantial evidence of record of such hearing and
shall set forth detailed findings of fact upon which the order is based.
(e) CONDITIONAL REGISTRATION.—
(1) The Administrator shall issue a notice of intent to cancel a regis-
tration issued under section 3(c)(7) of this Act if (A) the Administrator,
at any time during the period provided for satisfaction of any condition
imposed, determines mat die registrant has failed to initiate and pursue
appropriate action toward fulfilling any condition imposed, or (B) at the
Pesticides Inspection Manual 2-35 January 1989
-------
Chapter Two Pesticide Law and Definitions
S*C.6 HFRA 38
end of the period provided for satisfaction of any condition imposed,
four condition has not been met. The* Administrator may permit the con*
tinned sale and use of existing stocks of a pesticide whose conditional
registration Hlff *«•*" <*««tf»UH rm/Vr thi« yiifrfn^jnf^ (O TOfh *T!*T1t.
UQuCf SQCfl OQOQIOQDS* flDfl JOT SQCft Q9CS 9A tuG ••OfllUUStr&lOf 1Q8V
specify if the Adnunisnaor deaanmnes that such sate or use is not in-
consistent with the purposes of this Act and wffl not have unreasonable
adverse effects on the environment.
(2) A cancellation proposed under this subsection shall become final
and effective at the end of thirty days from receipt by the registrant of
the notice of intent to cancel v^n daring that ""»* a request for bear-
ing is made by a person adversely affected by the notice. If a hearing is
rpqufstfld. a bearing shall be conducted MTK^ subsection (d) of rtii-T sec-
tion. The only matters for resolution at **Mrt hearing shall be whether the
registrant has initiated and pursued appropriate action to comply with
the condition or conditions within the time provided or whether the
condition or conditions have been satisfied within the time provided,
anrf whether the Arlminignft^r'* Av^fmrnmtinn with RSpeCt tO the dis-
position of existing stocks is consistent with this ACL A decision after
completion of such hearing shall be final. Notwithstanding any other
provision of this section, a hearing shall be held and a determination
made within seventy-five days after receipt of a request for such hear-
ing.
(f) GENERAL PROVISIONS.—
(1) VOLUNTARY CANCELLATION.—A registrant at any time may request
that any of its pesticide registrations be canceled or be amended to
delete one or more uses. Before acting on such request, the Administra-
tor shall publish in the Federal Register a notice of the receipt of the
request. Thereafter, the Administrator may approve such a request
(2) PUBLICATION OF NOTICE.—A notice of denial of registration, intent
to cancel, suspension, or intent to suspend issued under this Act or a
notice issued under subsection (cX4) or (d)(5)(A) of section 4 shall be
published in the Federal Register and shall be sent by certified mail,
return receipt requested, to the registrant's or applicant's address of
record on file with the Administrator. If the mailed notice is returned to
the Administrator as undeliverable at foqt address, if delivery is refused,
or if the Administrator otherwise is unable to .accomplish delivery of
the notice to the registrant or applicant after making reasonable efforts
to do so, the notice shall be deemed to have been received by the regis-
trant or applicant on the date the notice was published in the Federal
Register.
(g) Nones FOR STORED PESTIODBS WRH CANCELED OR SUSPENDED REGIS-
TRATIONS.—
(1) IN GENERAL.—Any 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 any pesti-
cide which has had its' registration canceled or suspended under this
section shall notify the Administrator and appropriate Slate and local
officials of—
(A) such possession,
(B) the quantity of such pesticide such person possesses, and
(Q the place at which such pesticide is stored.
Pesticides Inspection Manual 2^6 January 1989
-------
Chapter Two Pesticide Law and Definitions
39 FffRA S«C. 8
(2) COPES.—The Administratcr shall transmit a copy of each notice
snbmined under this subsection to the regional office of the Environ-
mental Protection Agency which has jurisdiction over the place of pesti-
cide urmp* identified in the noticc.
(h) JUDICIAL RHVIHW.—Final orders of the Administrator under this section
shall be subject to judicial review pursuant to section 16.
SEC 7. [136*) REGISTRATION OF ESTABLISHMENTS.
(a) REQUIREMENT.—No person shall produce any pesticide subject to this
Act or active ingredient used in |"*fh"''ng a pr**?"** subject to *h** Act in
any State unless the establishment in which it s iB'Hhufil is registered with
the Administrator. The application far registration of aay esafaUshment shall
mHfl^»t dm name an«j ^ifr^^ of the *«*»Mi«tim«mf and of tte producer who
(b) REGISTRATION.—Whenever the Administrator receives an application
under subsection (a), he shall register die establishment and assign it an es-
tablishment number.
(c) INFORMATION REQUIRED.—
(1) Any producer operating an establishment registered under this
section shall inform the Administrator within 30 days after it is regis-
tered of the types and amounts of pesticides and, if applicable, active
ingredients used in producing pesticides—
(A) which he is currently producing;
(B) which he has produced during die past year; and
(C) which he has sold or distributed during the past year.
The information required by this paragraph shall be kept current and
submitted to the Administrator annually as required under such regula-
tions as the Administrator may prescribe.
(2) Any such producer shall, upon the request of the Administrator
for the purpose of issuing a stop sale order pursuant to section 13,
inform him of the name and address of any recipient of any pesticide
produced in any registered establishment which he operates.
(d) CONFIDENTIAL RECORDS AND INFORMATION.—Any information submit-
ted to the Administrator [•immm to subsection (c) other than the names of
the pesticides or active ingredients used in producing pesticides produced,
sold, or distributed at an establishment shall be considered confidential and
shall be subject to die provisions of section 10.
SEC ft, (13«n BOOKS AND RECORDS.
(a) REQUIREMENTS.—The Administrator may prescribe regulations requir-
ing producers, registrants, and applicants for registration to maintain such
records with respect to their operations and die pM!**"^ and devices pro-
duced as he determines are necessary for die effective enforcement of this
Act and to make die records available for inspection and copying in the
same manner as provided in subsection (b). No records required under this
subsection shall 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 registra-
tion has been filed).
(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 die Environ-
mental Protection Agency or of any State or political subdivision, duly des-
ignated by die Administrator, furnish or permit such person at all reasonable
Pesticides Inspection Manual 2-37 January 1989
-------
Chapter Two Pesticide Law and Definitions
SC.9 HFHA 40
times to have access to, and to copy: (1) all records snowing the delivery,
movement, or holding of such pesticide or device, including the quantity, the
due of shipment ***** rftceipt, and the "in1* of the* consignor and consignee!
or (2) in the event of me inability of any person to produce records contain*
UIB SQCu iopnnpflTiffn> ul Outer VBCQVBS ADO HUQKZD&QOO' fBuons to spcn dc*
livery, 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 d**"t pricing data,
personnel data, and ffjjMith ^arft (other ttv" <*•*• relating to registered pesti-
cides 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 es-
tablishment or other place where pesticides or devices are held for distribu-
tion 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. (134*1 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 A<*fn'n'WaKir are '"!t*'oriTf*1 to enter at reason-
able 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 regis-
tration of which has been suspended or canceled for the purpose of deter-
mining 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, ap-
propriate credentials and a written statement as to the reason for the inspec-
tion, 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. Par*1 such inspection «haH be commenced and completed with
reasonable promptness. If the officer or employee obtains any samples, prior
to leaving the premises, he 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 die portion retained. If an
analysis is made of such samples, a copy of die results of such analysis shall
be funusbed promptly to the owner, operator, or agent in charge.
(b) WARRANTS.—For purposes of enforcing the provisions of this Act and
upon a showing to an officer or 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, inspection, and copying of records for purposes of this sec-
tion or section 8;
(2) inspection and reproduction of all records showing me quantity,
date of shipment, and the name of consignor and consignee of any pes-
ticide or device found in the establishment which is adulterated, mis-
branded, not registered (in the case of a pesticide) or otherwise in viola-
Pesticides Inspection Manual 2-38 January 1989
-------
Chapter Two Pesticide Law and Definitions
41 RffiA StC.10
tion of this Aa and in the event of the inability of any person to
produce records containing such information, all other records and in-
formation relating to such delivery, movement, or holding of the pesti-
cide or device; and
(3) the seizure of any pesticide or device which is in violation of this
Act.
(c) ENFORCEMENT.—
(1) CERTIFICATION OF FACTS TO ATTORNEY GENERAL.—The examina-
tion of pesticides or devices shall be made in die Environmental Protec-
tion Agency or elsewhere at me Administrator may designate for the
puipose of detennmuig front such examinations whether they comply
with die lequiiemems of diis Act If it shall appear from any such ex-
amination that they fail to comply with the requirements of this Act, the
Administrator shall cause notice to be given to die person against whom
criminal or civil proceedings are contemplated. Any person so notified
shall be given an opportunity to present his views, either orally or in
writing, with regard to such contemplated proceedings, and if in the
opinion of the Administrator it appears that die provisions of this Act
have been violated by such person, then die Administrator shall certify
the facts to the Attorney General, with a copy of the results of the anal-
ysis or the examination of such pesticide for the institution of a crimi-
nal proceeding pursuant to section 14(b) or a civil proceeding under
section 14(a), when die Administrator determines dot such action will
be sufficient to effectuate the purposes of this Act.
(2) Nonce NOT REQUIRED.—The notice of contemplated proceedings
and opportunity to present views set forth in this subsection are not pre-
requisites to die institution of any proceeding by die Attorney General
(3) WARNING NOTICES.—Nothing in this Act shall be construed as re-
quiring the Arfmini^fm^ to insnTW* yiwfT^lipgff for prosecution of
minor violations of this Act whenever he believes dm die public inter-
est will be adequately served by a suitable written notice of warning.
SEC. 10. [U6k] PROTECTION OF TRADE SECRETS AND OTHER INFORMATION.
(a) IN GENERAL.—In submitting data required by this Act, die applicant
may (1) clearly mark any portions thereof which in his opinion are trade
secrets or commercial or financial information and (2) submit such marked
material separately from other "VBT*"! required to be submitted under this
Act
(b) DISCLOSURE.—Nbtwidistanding any other provision of this Act and
subject to the limitations in subsections (d) and (e) of ^f tminn. the Ad-
ministrator shall not make public information which m his judgment con-
tains or relates to trade secrets or commercial or fi«?««•"* information ob-
tained from a person and privileged or confidential, except due when neces-
sary to carry out the provisions of this Act information relating to formulas
of products acquired by authorization of this Act may be revealed to any
Federal agency consulted and may be revealed at a public hearing or in find-
ings of fact issued by die Administrator.
(c) DISPUTES.—If the Administrator proposes to release for inspection in-
formation which the applicant or registrant believes to be protected from dis-
closure under subsection (b), he shall notify die applicant or registrant, in
writing, by certified mail. The Administrator shall not thereafter make avail-
able for inspection such data until thirty days after receipt of die notice by
the applicant or registrant During this period, the applicant or registrant may
Pesticides Inspection Manual 2-39 January 1989
-------
Chapter Two Pesticide Law and Definitions
SK.10 _ HFRA _ 42
institute an action in an appropriate district court for a declaratory judgment
as to whether such information is subject to protection under subsection (b).
(d) LnOTATTONS.—
(1) All information w'ng the objectives, methodology, results,
or ggnifirance of any test or experiment performed op or won a regis-
tered or previously registered pesticide or its separate ingredients, impu-
rities, or degradation products, and any information concerning the ef-
fects of such pesticide on any organism or the behavior of such pesti-
cide in the environment, including, but not united to, data on safety to
fi$h and wildlife, hnmana and other "*•"""»!« plants, •"'"«»i« «mj soil
and studies OB persistence, tCBnslocaoon and fate m tho
plan
fate
metabolism, «nan ^0 available for /***r ^fn*" to the public The use
of such data for any registration purpose shall be governed by section 3
of this Act. This paragraph does not authorize me disclosure of any in-
formation that—
(A) discloses manufacturing or quality control pic
(B) discloses the details of any methods for testing, detecting, or
measuring the quantity of any deliberately added inert ingredient of
a pesticide, or
(Q discloses the identity or percentage quantity of any deliber-
ately added inert ingredient of a pesticide,
the Admintttrntnr ha« first determined that disclosure is neces-
sary to protect against an unreasonable risk of injury to health or the
(2) Information concerning production, distribution, sale; or invento-
ries of a pesticide that is otherwise entitled to confidential treatment
under subsection (b) of this section may be publicly disclosed in con-
nection with a public proceeding to determine whether a pesticide, or
any ingredient of a pesticide, causes unreasonable adverse effects on
health or the environment, if the Administrator determines that such
disclosure is necessary in the public interest
(3) If the Administrator proposes to disclose information described in
clause (A), (B), or (Q of paragraph (1) or in paragraph (2) of this sub-
section, the Arimini«in^iir tnaii notify by certified mail the ftnbcn'T*f' of
such information of the intent to release such information. The Admin-
istrator may not release such information, without the submitter's con-
sent, until thirty days after the submitter has been furnished such notice.
Where the Administrator finds that disclosure of information described
in clause (A), (B). or (Q of paragraph (1) of this subsection is neces-
sary to avoid or **s?m an imminent afM* «nh«tamiai risk of injury to the
public health, the Administrator may set such shorter period of notice
(but not less than ten days) and such method of notice as the Adminis-
trator finds appropriate. During such period the data submitter may in-
stitute an action in an appropriate district court to enjoin or limit the
proposed disclosure. The court may enjoin disclosure, or limit the dis-
closure or the parties to whom disclosure shall be made, to the extent
that—
(A) in die case of information described in clause (A), (B), or
(Q of paragraph (1) of this subsection, the proposed disclosure is
not required to protect against an unreasonable risk of injury to
health or the environmenq or
(B) in the case of information described in paragraph (2) of this
subsection, the public interest in availability of the information in
Pesticides Inspection Manual 2-40 January 1989
-------
Chapter Two Pesticide Law and Definitions
43 _ FjFHA _ Sac. 10
the public proceeding does not outweigh die interests in preserving
the confidcpt*n*'ty of the information.
(e) DISCLOSURE TO CONTRACTORS.— Information otherwise protected from
disclosure to !K* p***^ fH*^ subsection (b) of *h*f yytiim may be diifc
to contractors with the United States and employees of such contractors if,
in the opinion of the Arftnini
-------
Chapter Two Pesticide Law and Definitions
Sec. 11 FJFRA . 44
(3) Section 1001 of tide 18 of the United States Code shall apply to any
affirmation man* ^nH^f paragraph (1) of rt"T jBiltwtiifii
SEC IL iiaai USE OF RESTRICTED USE PESTICIDES; APPPUCATOBS »-*.
(a) CERTIFICATION PROCEDURE.—
(1) FEDERAL CERTIFICATION.—In any State for which a State plan for
applicator certification has not been approved by the Administrator, the
Administrator, in consultation with the Governor of such State, shall
conduct a program to the certification of applicators of pesticides.
Such program shall conform to the requirements imposed upon the
States under the provisions of subsection (aXZ) of this section and shall
not reuuM private apr*'ra><1T* to take any exammmon to rflp*******
competency m the use of pesticides. Prior to the implementation of the
program, the Administrator shall publish in the Federal Register for
review and comment a summary of the Federal plan for applicator certi-
fication and shall make generally available within the State copies of
the plan. The Administrator shall hold public hearings at one or more
locations within the State if so requested by the Governor of such State
during the thirty days following publication of the Federal Register
notice inviting comment on the Federal plan. The bearings shall be held
within thirty days following receipt of the request from the Governor.
In any State in which the Administrator conducts a certification pro-
gram, the Administrator may require any person engaging in the com-
mercial application, sale, offering for sale, holding for sate, or distribu-
tion of any pesticide one or more uses of which have been classified for
restricted use to maintain such records and submit such reports concern-
ing the commercial application, sale, or distribution of such pesticide as
the Administrator may be regulation prescribe. Subject to paragraph (2),
the Administrator shall prescribe standards for the certification of appli-
cators of pesticides. Such standards shall provide that to be certified, an
individual must be determined to be competent with respect to the use
and handling of pesticides, or to the use and handling of the pesticide
or class of pesticides covered by such individual's certification. The
certification standard for a private applicator shall, under a State plan
submitted for approval, be deemed fulfilled by his completing a certifi-
cation form. The Administrator shall further assure that such form con-
tains flrtf^piatf information and affirmations to carry out the intent of
this Act, and may include in the form an affirmation that the private
applicator has completed a training program approved by the Adminis-
trator so long as the program does not require the private applicator to
take, pursuant to a requirement prescribed by the Aflfn"1'qrntnf'i any ex-
amination to establish competency in the use of die pesticide. The Ad-
ministrator may require any pesticide dealer participating in a certifica-
tion program to be licensed under a Slate licensing program approved
by him.
(2) STATE CERTIFICATION.—If any State, at any time, desires to certify
applicators of pesticides, the Governor of such State shall submit a
State plan for such purpose. The Administrator shall approve the plan
submitted by any State, or any modification thereof, if such plan in his
judgment—
(A) designates a State agency as the agency responsible for ad-
ministering the plan throughout the State;
Pesticides Inspection Manual 2-42 January 1989
-------
Chapter Two Pesticide Law and Definitions
45 _ RRU _ SIC. 12
(B) contains satisfactory assurances that such agency has or will
have the legal authority and qualified personnel necessary to carry
out the plan;
(Q gives «^i«f»«-*wy atmranm that (be State will devote ade-
quate funds to the administration of the plan;
(D) provides that the State agency will make such reports to the
- in such form and containing such information as the
tO CUDC fCQUUC* 8DQ
(B) contains miifatMy assurances that State standards for the
certification of applicators of pesticides conform with those stand-
ards prescribed by the Administrator under paragraph (1).
Any State certification p*mpaip under tfrf* yrtity «h»ii be maintained
in acCTpfy"*** with the State plan approved un^jfr ***** section.
(b) STATE PLANS.— If the Administrator rejects a p|at| fflhTittyf under this
paragraph, he shall afford the State submitting the plan due notice and op-
portunity for hearing before so doing. If the Administrator approves a plan
submitted urvtfr
-------
Chapter Two Pesticide Law and Definitions
S«C.12 _ FIFBA _ 46
(Q my regisared pesticide the composition of which differs at
the tune of its distribution or nlft from its
-------
Chapter Two Pesticide Law and Definitions
47 RFRA 8ifc 12
(L) who is a producer to violate any of the provisions of section
7;
(M) to knowingly falsify all or put of any application for regis-
mtian, qipHcarion for experimental use permit, any information
the AdB0nistranr riling*" to section 7, any records
P^mi^TCo tO 06 OfllDtSlflCft TMBUBDt tO UUS Act* 3DV FCDOTt
ostler tlhiff Act* of soy lOuxotifiOQ mflnoBd sts confidential 3nd sub™
mined to the Administrator under any provision of this Act;
(N) who is a registrant, wholesaler, dealer, retailer, or other dis-
tributor to fail to file repots inquired by this Ace
(O) ID add any substance n, or like any substance from, any
pesticide in a manner that may defeat die purpose of this Ace
or1*4
(P) to use any pesticide in tests on human beings unless such
human beings (i) are fully informed of the nature and purposes of
the test and of any physical and menial health consequences which
are reasonably foreseeable therefrom, and (ii) freely volunteer to
participate in die test **
(Q) to falsify ail or pan of any information relating to die test-
ing of any pesticide (or any ingredient, metabolite, or degradation
product thereof), meinHing the nature of any protocol, procedure.
substance, utgaiKiiii, or equipment used, observation made, or con-
clusion or opinion formed, submitted to the Administrator, or that
the person knows will be furnished to the Administrator or will
become a pan of any records required to be maintained by this
Ace
(R) to submit to die Administrator data known to be false in
suppoit of a registration; or
(S) to violate any regulation issued under section 3(a) or 19.
(b) EXEMPTIONS.—The penalties provided for a violation of paragraph (1)
of subsection (a) shall not apply to—
(1) any person who establishes a guaranty signed by, and containing
the name and address of, die registrant or person residing in the United
Slates from whom he purchased or received in good faith the pesticide
in the same unbroken package, to the effect that die pesticide was law-
fully registered at die time of sale and delivery to him, and that it com-
plies with the other requirements of this Act, and in such case the guar-
antor shall be subject to die penalties which would otherwise attach to
the person holding the guaranty under the provisions of this Ace
(2) any carrier white lawfully shipping, transporting, or delivering for
shipment any pesticide or device, if such carrier upon request of any
otliccr or employee duly o?ffiffpflt^* by thfr AdiiniiiifiHf^^^ siiAil permit
such officer or employee to copy vail of its records concerning such pes-
ticide or device;
(3) any public official while engaged in die performance of his offi-
cial duties;
(4) any person using or possessing any pesticide as provided by an
experimental use permit in effect with respect to such pesticide and
such use or possession; or
Pesticides Inspection Manual 2-45 January 1989
-------
Chapter Two Pesticide Law and Definitions
Sac. t3 _ RFHA _ 48
(5) any person who ships a Bifrstancg or mixture of substances bffi"g
put through tests in which the purpose is only to determine its value for
pesticide purposes or to detennine its toxicity or other uiupoues and
uOID ^VfllCfl tuO U9Cf ClOCS HOC GXDQCt tD IOC61V6 flOV DCOCtlt 1O DCSC'- COO*
trol from to use.
SBC 13. [Utfk] STOP SALX, USB, REMOVAL, AND SEIZURE.
(a) STOP SALE, ETC., ORDERS. — Whenever any pesticide or device is found
by the Administrator in any State and tbere is reason to believe on the frflsw
of inspection or tests that such pesticide or device is in violation of any of
the provisions of this Act, or dot such pesdcide or device has been or is
intended to be distributed or sold in violation of any such provisions, or
when the registration of the pgsricidff fa** been <^"^»>*H by a final order or
has been suspended, the Administrator may issue a written or printed "stop
sale, use, or removal" order to any person who owns, controls, or has custo-
dy of such pesticide or device, and afar receipt of such order no person
shall sell, use, or remove the pesticide or device described in me order
except in accordance with the provisions of the order.
(b) SEIZURE.— Any pesticide or device that is being transported or, having
bsen transported, "mains unsold or in original unbroken packages, or fan* is
sold or offered for sale in any State, or that is imported from a foreign coun-
try, shall be liable to be proceeded against in my district court in the district
where it is found and seized for ?""fiyqpQ" by a process in ran for con-
demnation if—
(1) in the case of a pesticide—
(A) it is adulterated or misNamlcd;
(B) it is not registered pursuant to the provisions of section 3;
(Q its labeling fails to be* the information required by this
Act;
(D) it is not colored or discolored and such coloring or discolor-
ing is required under mis Act; or
(E) any of die claims made for it or any of the directions for its
use differ in substance fry^ the representations made in connection
with its
(2) in the case of a device, it is nusbranded; or
(3) in the case of a pesticide or device, when used in accordance with
the requirements imposed under this Act and as directed by the label-
ing, it nevertheless causes unreasonable adverse effects on the environ-
ment.
In the case of a plant regulator, defoliant, or desiccant, used in accordance
with the i^bel claims and ffrrftT*ifnr|v|'rTionff, physical or physiological effects
on plants or pans thereof shall not be deemed to be injury, when such ef-
fects are the purpose for which the plant regulator, defiant, or desiccant
was applied.
(c) DISPOSITION AFTER CONDEMNATION.— If the pesticide or device is con-
demned it shall, after entry of the decree, be disposed of by destruction or
sale as the court may direct and the proceeds, if sold, less die court costs,
shall be paid into the Treasury of the United States, but the pesticide or
device shall not be sold contrary to the provisions of this Act or the laws of
the jurisdiction in which it is sold. On payment of the costs of the condem-
nation proceedings and the execution and delivery of a good *n
-------
Chapter Two Pesticide Law and Definitions
49 _ RFHA _ Sac. 14
livered to the owner thereof. The proceedings of such condemnation cases
«h»n confonn, as T ai may be to mo proceedings in admiralty, except that
either pany may demand trial by jvy of any issue of fact joined in any case,
nmf ail TOffr ^lyoojingf fhaii £3 at me ant of and in die «»"»• of me
United States.
(d) COURT COSTS, ETC.— When a decree of condemnation is entered
against the pesticide or device, court costs and fees, storage, and other
proper expenses shall be awarded against the person, if any, intervening as
rln«r»gn| Q{ fog pfftiriH^ Qf device.
SEC 14. (130| PENALTIES.
(a) Ova, PENALTIES. —
(1) IN GENERAL. — Any registrant, commercial applicator, wholesaler,
dealer, retailer, or other distributer who violates any provision of this
Act may be assessed a civil penalty by the Administrator of not more
than $5,000 for each offense.
(2) PRIVATE AFPUCATOR. — Any privatt applicator or other person not
included in paragraph (1) who violates any provision of this Act subse-
quent to receiving a written waning from the Administrator or follow-
ing a citation for a odor violation, may be assessed a civil penalty by
the Administrator of not more than $1,000 for each offense: Provided,
That any applicator not included under paragraph (1) of this subsection
who holds or applies registered pesticides, or use dilutions of registered
pesticides, only to provide a service of controlling pests without deliv-
ering any unapplied pesticide to any person so served, and who violates
any provision of this Act may be assessed a civil penalty by the Ad-
ministrator of not more than $500 for the first offense nor more than
$1,000 for each subsequent offense.
(3) HEARING. — No civil penalty shall be •««»««•<« unless die person
charged shall have been given notice and opportunity for a hearing on
such charge in die county, pnrish, or incorporated city of the residence
of the person charged.
(4) DETERMINATION OF PENALTY.— In determining die amount of the
penalty, the Administrator shall consider the appropriateness of such
penalty to die size of die business of die person charged, die effect on
d* person's ability to continue in business, and die gravity of die viola-
tion. Whenever the Arhnini««Tatnr fin^f that tnc violation occurred de-
spite die exercise of due care or did not cause significant harm to health
or die environment, die Administrator may issue a warning in lieu of
assessing a penalty.
(5) REFERENCES TO ATTORNEY OENBRAL. — In case of inability to col-
lect such civil penalty or failure of any person to pay all, or such por-
tion of such civil penalty as die Administrator may determine, die Ad-
ministrator shall refer die matter to die Attorney General, who shall re-
cover such amount by action in me appropriate United States district
court.
(b) CRIMINAL PENALTIES. —
(1) IN GENERAL.—
(A) Any registrant, applicant for a registration,
-------
Chapter Two Pesticide Law and Definitions
S«c. 15 flPHA 50
or sells pesticides or devices, who knowingly violates any provi-
sion of otia Act shall be fined not more than $23,000 or impris-
oned for not more thai 1 year, or both.
(Z) PRIVATE AfPUCATOL—Any privue appakaaar or other person not
included in paiagiaph (1) **o knowingly violates any provision of this
Act shall be guilty of a misdemeanor and shall on conviction be fined
not more than $1,000, or imprisoned for not more than 30 days, or
both.
(3) DISCLOSURE OF INFORMATION.—Any person, who, with intent to
defraud, uses or reveals information relative to formulas of products ac-
quired under the authority of section 3, shall be fined not more than
$10,000, or imprisoned for not more dun three yean, or botb.
(4) Acn OF OFFICERS, AGENTS, ETC.—When construing and enforcing
the provisions of this Act, the act, fcnittJon, or failure of any officer,
agent, or other person acting for or employed by any person shall in
every case be also deemed to be tht act. omission, or failure of such
person as well as that of the person employed.
SIC. IS. INDEMNTTED.
(a) GENERAL INDEMNIFICATION.—
(1) IN GENERAL.—Except as otherwise provided in this section, if—
(A) the Administrator notifies a registrant under section 6
-------
Chapter Two Pesticide Law and Definitions
51 WKA Sac. 18
(1) END USERS.—If—
(A) the Administrator notifies * registrant under section 6(c)(l)
&at die Administrator intends to suspend a registration or thnt an
emergency order of suspension of a- reguntion under section
6(cX3) has been issued;
(B) the registration in question is suspended under section 6(c),
and thereafter is canceled under section 6(b), 6(d), or 6(f); and
(Q any person who, immcriiairly before the notice to the regis-
trant under subparagraph (A), owned any quantity of the pesticide
for purposes of applying or using the pesticide as an end user,
rather than for puipusu of distributing or selling it or further proc-
essing it for distribution or sate, suffered a loss by reason of the
suspension or rantnllarinn of the pesticide;
the person shall bo entitled to an indemnity payment under this subsec-
tion for such quantity of the pesticide.
(2) DEALERS AND DBTWBUTORS.--
(A) Any registrant, wholesaler, dealer, or other distributor (here-
inafter in this paragraph referred to as a "seller") of a registered
pesticidt who distributes or sells the pesticide directly to any
person not described as an end user in paragraph (1XQ shall, with
respect to any quantity of the pesticide that such person cannot use
or resell as a result of the suspension or cancellation of the pesti-
cide, reimburse such person for the cost of first acquiring the pesti-
cide from the seller (other than the cost of transportation, if any),
unless the seller provided to the person at the time of distribution
or sale a notice, in writing, that the pesticide is not subject to reim-
bursement by the seller.
(B)If—
(0 the Ajnisffi|tr>r notifies a registrant under section
6(cXl) that the Administrator intends to suspend a registration
or that an emergency order of suspension of a registration
under section 6(c)(3) has been issued;
(ii) the registration in question is suspended under section
6(c), and thereafter is canceled under section 6(b), 6(d), or
6X0;
(iii) any person who, immediately before the notice to the
registrant under clause (i>~
(I) had not been notified in writing by the seller, as
provided under sobpaitagiaph (A), that any quantity of
the pesticide owned by such person is not subject to re-
imbursement by the seller in the event of suspensiou or
ellation of the pesticide; and
(II) owned any quantity of the pesticide for purposes
of—
(aa) distributing or selling it; or
(bb) further processing it for distribution or sale
directly to an end user;
suffered a loss by reason of the suspension or cancellation of
the pesticide; and
(iv) the Administrator determines on the basis of a claim of
loss submitted to the Administrator by the person, that the
seller
Pesticides Inspection Manual 2-49 January 1989
-------
Chapter Two Pesticide Law and Definitions
S+c.16 HFRA 52
(I) did not provide the notice specified in subparagraph
(A) to such person; and
(H) is and will continue to be unable to provide renn-
buisement to snch ueiauB, ae provided under subpan*
guph (A), for the ba referred to in clause (iii). as a
of the insolvency or bankruptcy of the seller and
seller's resulting inability to provide such reimburse-
tfae person shall be entitled to aa indemnity payment under this
subsection for such quantity of the pnricidf.
(Q If an indemnity payment is made by the United States under
raph, the United States shall be aubrogated to any right
that would otherwise be held under mis paragraph by a seller who
is unable to make a reimbursement in accordance with this para-
graph with regard to reimbursements that otherwise would have
been made by the seller.
(3) SOURCE.—Any payment required to be made under paragraph (1)
or (2) shall be made from the appropriation provided under section
1304 of title 31, United Stales Code.
(4) ADMNBTRATrvB SETTLEMENT.—An administrative settlement of a
claim for such indemnity may be made in accordance with the third
paragraph of section 2414 of tide 28, United Slates Code, and shall be
regarded as if it were made under that section for purposes of section
1304 of title 31, United States Code.
(c) AMOUNT OP PAYMENT.—
(1) IN GENERAL.—The amount of an indemnity payment under sub-
section (a) or (b) to any person shall be A-tumin^ on the basis of the
cost of die pesticide owned by the person (other than die cost of trans-
portation, if any) immediately before the issuance of the notice to the
registrant referred to in subsection (aXIXA). (bXD(A). or (b)(2)(B)(i),
except that in no event shall an indemnity payment to any person
exceed the fair market value of the pesticide owned by tbs person im-
mediately before the issuance of the notice.
(2) SPECIAL RULE.—Notwithstanding any other provision of this Act,
die Administrator may provide a reasonable time for use or other dis-
posal of die pesticide. In determining die quantity of any pesticide for
which indemnity shall be paid under this section, proper adjustment
shall be made for any pesticide used or otherwise disposed of by me
owner.
SEC IS. [Ufa] ADMINISTRATIVE PROCEDURE; JUDICIAL REVIEW.
(a) DISTRICT COURT REVIEW.—Except as otherwise provided in this Act,
the refusal of die A^tntpigrgrpf to i^iwi or nuapfiKi a registration or to
change a e»««rifi«>tinii not following a hearing and other final actions of die
Administrator not committed to die discretion of die Administrator by law
are judicially reviewable by the district courts of die United States.
(b) REVIEW BY COURT OP APPEALS.—In the case of actual controversy as
to the validity of any order issued by the Administrator following a public
hearing, any person who will be adversely affected by such order and who
hfld been a party to the proceedings may obtain judicial review by filing in
the United States court of appeals for the circuit wherein such person resides
or has a place of business, widiin 60 days after the entry of such order, a
petition praying that the order be set aside in whole or in pan. A copy of the
petition shall be forthwith transmitted by the dak of die conn to the Ad-
Pesticides Inspection Manual 2-50 January 1989
-------
Chapter Two Pesticide Law and Definitions
53 HFRA StC.17
minisnator or any officer d^gpatyl by him for that purpose, and thereupon
the Administrator shall file in the court the record of the proceedings on
which he based his order, as provided in section 2112 of title 28, United
States. Code. Upon the filing of such petition the court shall have exclusive
jurisdiction to affirm or set aside the order <^mpifl">H of in whole or in
pan. The court shall consider all evidence of record. The order of the Ad-
ministrator shall be sintainBd if it is supported by substantial evidence when
considered on the record as a whole. The judgment of the court affirming or
setting aside, in whole or in pan. any order under this section shall be final,
subject to review by the Supreaw Conn of die United States upon cernorari
or certification as provided in sectiom 1254- of title 28 of the United States
Code. The commencement of proceedings, under this section shall not. unless
specifically ordered by fb» conn to tin contrary, operate at a- stay of an
order:
(c) JURISDICTION OP Donucr COURTS.— The district courts of the United
States are vested with jurisdiction specifically to enforce, and to prevent and
restrain violations of, mis Act
(d) Nona OF JUDGMENTS.— The Administrator shall, by publication in
such manner as he may prescribe, give nonce of all judgments entered in
actions instituted under the authority of this ACL
SEC 17. [Ufa] IMPORTS AND EXPORTS.
(a) PBsnoDBS AND DEVICES INTENDED POX EXPORT.— Notwithstanding any
other provision 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 direc-
tions 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
-------
Chapter Two Pesticide Law and Definitions
SIC. 18 F1PRA 54
forth in this Act. as a otherwise injurious to health or the environment, the
pesticide or device may be refused admission, and the Secretary of the
Treasury shall refuse delivery to the consignee and shall cause the destruc-
tion of any pesticide or device refused delivery which shall not be exported
by the comBgnec wiihu 90 days from the date of notice of such refusal
under such regulations as the Secretary of the Treasury may prescribe. The
Secretary of the Treasury may deliver to the consignee such pesticide or
device pending **?""«"»ri»" and dfc'**"** in the mmer on execution of bond
for the amount of the full invoice value of sock pesticide or device, together
with the duty thereon, and OB refusal ID return such pesticide or device for
any cause to the custody of the Secretary of me Treasury, when *if*^^f4l
for the purpose of excluding them from the country, or for any other pur-
pose, said consignee shall forfeit the full amount of said bond. All charges
for storage, cartage, and labor on pesticides or devices which are refused
admission or delivery shall be paid by me owner or consignee, and in de-
fault of such payment T*fH constitute a lici* •§•»"«* any future hpfFmio"
made by such owner or consignee.
(d) COOPERATION IN INTERNATIONAL EPPDRTS.—The Administrator shall, in
cooperation with the Department of Slate and any otherappropriate Federal
agency, participate and cooperate in any international efforts to develop im-
proved pesticide research and regulations.
(e) REGULATIONS.—The Secretary of the Treasury, inconsunarinn with the
Administrator, shall prescribe regulations for the enforcement of subsection
(c) of this section.
SIC IS. (136p] EXEMPTION OF FEDERAL AND STATE AGENCIES.
The Arfmiififttnfly may, at his discretion, exempt any Federal or State
agency from any provision of this Act if be determines mat emergency con-
ditions exist which require such exemption. The Administrator, in determin-
ing whether or not such emergency conditions CTJM, qfraii cfl"inilt with the
Secretary of Agriculture and the Goveraor of any State concerned if they
request such determination.
SEC. 19. [13*|] STORAGE, DISPOSAL, TRANSPORTATION, AND RECALL.
(a) STORAGE, DBPOSAL, AND TRANSPORTATION.—
(1) DATA REQUIREMENTS AND REGISTRATION OP PESTICIDES.—The Ad-
ministrator may require under section 3 or 6 thai—
(A) the registrant or applicant for regisntion of a pesticide
submit or cite data or information regarding methods for the safe
storage and disposal of excess quantities of the pesticide to support
the regisntion or continued registration of a pesticide!
(B) the labeling of a pmtfe'd* contain requirements and proce-
dures for the transportation, storage, and disposal of the pesticide,
any container of the pesticide, any rinsate containing the pesticide,
or any other material used to contain or collect excess or spilled
quantities of the pesticide; and
(Q the registrant of a pesticide provide evidence of sufficient
financial and other resources to carry put a recall plan under sub-
section (b), and provide for the disposition of die pesticide, in me
event of suspension and cancellation of the pesticide.
(2) PESTICIDES.—The Administrator may by regulation, or as part of
an order issued under section 6 or an amendment to sue* an order—
(A) issue requirements and procedures to be followed by any
person who stares or transports a pesticide the registration of
which hflf bffn suspended or canceled;
Pesticides Inspection Manual 2-52 January 1989
-------
Chapter Two Pesticide Law and Definitions
55 _ RFHA _ SK.19
(B) issue requirements and procedures to be followed by any
person who disposes of stocks of a pesticide the registration of
which has been suspended; and
(O MBB requirements and procedures for the disposal of any
pencide dtt regcnooft of which hat been canceled.
(3) CONTAINERS, RINSATES, AND OTHER MATERIALS.— The Administra-
tor may by regulation, or as pan of an order issued under section 6 or
an amendment to such an order —
(A) issue requirements and procedures to be followed by any
person who iioies or transports any cononner of a pcnicin* the
ox ^wucjt ORB oeen susneoded or caDCtied* snv
coBtaminK tne Desndoe* or aw otner material useu to concam of
collect excess or spilled quantities of the pesticide;
(B) issue requirements and procedures to be followed by any
person who disposes of stocks of any container of a pesticide the
registration of which *"*!? been suspended, any *«««•«* containing
the pesticide, or any other material used to contain or collect
excess or spilled quantities of due pesticide; and
(Q issue requirements and procedures for die disposal of any
container of a pesticide die registration of which has been can-
celed, any rinsate containing the pesticide, or any other material
used to contain or collect excess or spilled quantities of the pesti-
cide.
(b) RECALLS. —
(1) IN GENERAL. — If the registration of a pesticide has been suspended
and canceled under section 6, and if the Administrator finds thai recall
of the pesticide is necessary to protect health or die environment, die
Administrator «haii order a recall of die p*ttirHlf in accordance with
thiit subsection.
(2) VOLUNTARY RPTAII, — If, after determining under paragraph (1)
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, die A/fpi'n*wntnf than request the
registrant of die pesticide to submit, within 60 days of die request, a
plan for die voluntary recall of the pesticide. If such a plan is requested
and submitted, die Administrator shall approve die p**" and order die
registrant to conduct die recall in accordance with die plan unless the
determines, after an informal hearing, tfrM the plan is in-
adequate to protect health or die environment
(3) MANDATORY RECALL.— If, after determining under paragraph (1)
that a recall is necessary, die Administrator -does not request die sub-
mission of a plan under paragraph (2) or finds such a plan to be inad-
equate, the Administrator shall issue a regulation that prescribes a plan
for die 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 die pesticide, or any successor in interest to such a person.
(4) RECALL PROCEDURE. — A regulation issued under this subsection
may require any person that is subject to die regulation to —
(A) arrange to make available one or more storage facilities to
receive and store the pesticide to which the recall program applies,
and inform die Administrator of the location of each such facility;
(B) accept and store at such a facility those existing stocks of
such pesticide dm are tendered by any other person who obtained
Pesticides Inspection Manual 2-53 January 1989
-------
Chapter Two Pesticide Law and Definitions
Stfclfr HHU 56
the pesticide directly or indirectly from the peaoo thai is subject
to such regulation;
(C) on the request of a person making, such ft tender, provide fbr
proper mnspotuiaa of the pesticide to stsange facility; and
JD)tate such reasonable saps as: die regulation may prescribe to
UI£LHUI persons' who may be holders of the pcsticider of the tenns
of the recall regulation and how those persons may lender the pes-
node and arrange for transportation of the pesticide to a> storage
facility.
(5) CONTORT OF RBCMJL FLAN.—A recall plan established under this.
(A) the level iff the distribntioa chant to which the recall is. to
anH . yt^faHy fgg pBCSil *****
_
(By die means to be used to* verify die effectiveness of die
recalL _
(6) REQUIREMENTS OR ntocsDUHS.— No requirement or procedure
impn«gH m a^ffjn^aneet mitt paragraph (3) of tnhanrtinii (•) may
the recall of existing sacks of the pesticide except at provided by diis
(c) STOKAOB COSTS.—
(1) SUBMISSION OF PLAN.—A registrant who wishes to become eligi-
ble for reimbursement of storage costs, incurred as & result of a recall
ibed under subsection (b) fox a* pesticide whose regisuniiiun has
' suspended and canceled shall, aesoon as practicable after the i
pfflifflfl of the registration of the pesticidei submit to the Ailminisuauji1
a» plan for the storage **"* fH«tm«gi. o£ the p^ffy'd* that, mtfffi criteria'
established by die Admntisttator by regulation;
(2) REnanjBSEMENr.—-Within a rrasonabkr period of time after such
SlOnUBB COCtS- JVft ID6QER9B XD^t DBUtl1 OV CDB* XQflBSO'H&t* tD6 /VuDBUUfl
shalLrehnom
(A) none of dw costs, incurred by die legiauam before die date
of submission of the plan referred, to iff paragraph (1) to the Ad-
(B) 100 petcent of the costs iiiLimett by the registrant after the
dace of submission of the phw to* the Administrator or the date of
csBceuatioff or the vBEBtranon 01 the nesocidev whichever* is later,
but before the approval of the pun by the
(C) SO percent of the costs incurred by the registrant during the
f-ye» period beginning' on die date of me approval of die plan' by
date of ''•nrHJuiKr* of the «•[•••"•''""• of
thejpesoade, whichever i* later;
(D) none of the cosoc incurred by the registrant during^ the* 3-year
period: beginning on die 366th day following approval of the plan
by the Administrator or the ***** of cancellation of the registration
of Ute pnsricide; whichever is later and
(E) 25 peicent of the COSB inrurrfd by the registrant during die
period beginning, on die first day of the 5th year following die date
of die approval of the plan by die Administrator or die date of can-
cellation of the registration of die pesticide; whichever is later, and
ending on die date that a disposal permit for the pesticide is issued
by a> State or an alternative plan for disposal of the pesticide in
accordance widi applicable law has been developed.
Pesticides Inspection Manual 2-54 January 1989
-------
Chapter Two Pesticide Law and Definitions
57 RFRA SK.19
(d) ADMINISTRATION OP STORAOE, DISPOSAL, TRANSPORTATION, AND RECALL
PROGRAMS.—
(1) VOLUNTARY AGREEMENTS.—Nothing in this section shall be con-
strued as preventing or making unlawful any agreement between a
seller and a buyer of any pesticide or other substance regarding the ulti-
mate allocation of the coats of storage, transportation, or disposal of a
pesticide.
(2) RULE AND REGULATION REVIEW.—Section 23(a)(4) shall not apply
to any regulation issued onder aabwciion (a)(2) or (b).
(3) LIMITATIONS.—No registrant shall be responsible under this sec-
tion for a pesticide the registration of which is held by another person.
No distributor or seller shall be responsible under this section for a pes-
ticide that the distriboior or seller did not hold or sell.
(4) SEIZURE AND PENALTIES.—If tne Administrator finds that a person
who is subject to a regulation or order under subsection (aX2) or (b)
has flailed substantially to comply with that regulation or order, the Ad-
ministrator may take action under section 13 or 14 or obtain injunctive
relief under section 16(c) against such person or any successor in inter-
est of any such person.
(e) CONTAINER DESIGN.—
(1) PROCEDURES.—
(A) Not later than 3 yean after the effective date of this subsec-
tion [December 24, 1988], the Administrator shall, in consultation
with the heads of other interested Federal agencies, promulgate
regulations for the design of pesticide containers that will promote
the safe storage and disposal of pesticides.
(B) The regulations shall ensure, to the fullest extent practicable,
that the containers—
(i) accommodate procedures used for the removal of pesti-
cides from the containers aod the rinsing of the containers;
(ii) facilitate the safe use of the containers, including elimi-
nation of splash and leakage of pesticides from the containers;
(iii) facilitate the safe disposal of the containers; and
(iv) facilitate the safe refill and reuse of the containers.
(2) COMPLIANCE.—The Administrator shall require compliance with
the regulations referred to in paragraph (1) not later than 5 years after
the effective date of this subsection [December 24,1988].
(0 PESTICIDE RESIDUE REMOVAL.—
(1) PROCEDURES.—
(A) Not later than 3 years after the effective date of this subsec-
tion [December 24, 1988], the Administrator shall in consultation
with the heads of other interested Federal agencies, promulgate
regulations prescribing procedures and standards for the removal of
pesticides from containers prior to disposal.
(B) The regulations may—
(i) specify, for each major type of pesticide container, pro-
cedures and standards providing for, at a minimum, triple
rinsing or the equivalent degree of pesticide removal;
(ii) specify procedures that can be implemented promptly
and easily in various circumstances and conditions;
(iii) provide for reuse, whenever practicable, or disposal of
rinse water and residue; and
Pesticides Inspection Manual 2-55 January 1989
-------
Chapter Two Pesticide Law and Definitions
S«C.20 _ _ __ RFRA _ 58
(iv) be coontinatBd with requirements for the rinsing of
containers imposed under the Solid Wane Disposal Act (42
U.S.C. 6901 et seq.).
(C) UK Administrator may, at the discretion of the Adninisoar
tor, exempt products intended solely for household use from die
ox this
(2) COMPLIANCE. — Effective beginning 5 years after the effective date
of this subsection [December 24, 1988], a State may not exercise pri-
mary enforcement responsibility under section 26, or certify an applica-
tor under section 11, unless the Adiniawiam determines mat the State
is carrying out an adequate |ff"t{ian •> entire fnmpHamv* TOIQ thi« sub-
section.
(3) SOLID WASTE DISPOSAL ACT.— Nothing in dm subsection shall
affect the authorities or requirements concerning pesticide containers
under the Solid Waste Disposal Act (42 U.S.C. 6901).
(g) PESTTODB CONTAINER STUDY. —
(1) STUDY.—
(A) The Administrator shall conduct a study of options to en-
courage or require-
(i) die return, refill, and reuse of pesticide containers;
(ii) the development and use of pesticide formulations that
facilitate the removal of pesticide residues from containers;
(iii) die use of bulk storage facilities to reduce the number
of pesticide containers requiring disposal.
(B) In conducting die study, die Administrator shall—
(i) consult with die beads of ocher interested Federal agen-
cies. State agencies, industry groups, and environmental orga-
and
(ii) assess the feasibility, costs, and environmental benefits
of encouraging or requiring various measures or actions.
(2) REPORT.—Not later man 2 yean after die effective date of this
subsection [December 24, 1988], die Administrator shall submit to Con-
gress a report describing the results of the study required under
paragraph (1).
(h) RELATIONSHIP TO SOUP WASTE DISPOSAL ACT.—Nothing in this sec-
tion shall diminish the authorities or requirements of the Solid Waste Dis-
posal Act (42 U.S.C. 6901 et seq.).
SEC 20. [Ute] RESEARCH AND MONITORING.
(a) RESEARCH.—The Arfmini
-------
Chapter Two Pesticide Law and Definitions
a BfflA SiC. 23
lish procedures for the monitoring of map and animals and their environment
for incMlffltal p*tticid^ exposure, including, but not limited to, the quantifi-
cation of inc"f***n| human and environmental ptirricidft pollution and the
madtf aemfa thereof, Mid idenrificflrion of tha inmeei trf nont«mtn«tinn yrf
their relationship to human and environmental effects. Such activities sNI*
be carried out in cooperation with other Federal, State, and local agencies.
SEC 21. (1364 SOLICITATION OF COMMENTS; NOTICE OP PUBLIC HEARINGS.
(a) SECRETARY OP AGRICULTURE.—The Administrator, before publishing
regulations under dm Act, shall solicit the views of me Secretary of Agri-
culture in accordance with the procedure described ia section 25(a).
(b) VIEWS*—ID addition to any outer mrtMity ••*«ii«j to public hearings
and solicitation of views. • connection with the suspension or cancellation
of a pesticide registration or any other actions authorized under this Act, the
AHminiyratnr may, at his discretion, solicit the views of all '"^""wj per-
sons, either orally or in writing, and seek such advice from scientists, fann-
ers, farm organizations, and other qualified persons at he deems proper.
(c) NOTICE.—In connection with all public hearings under mis Act the Ad-
mjpigffaipr ghaii publish timely notice of such ^Tiring? in the Federal Regis*
ter.
SEC 22. [1361] DELEGATION AND COOPERATION.
(a) DELEGATION.—All authority vested in the Administrator by virtue of
the provisions of this Act may with like force and effect be executed by
such employees of the Environmental Protection Agency as the Administra-
tor may designate for the purpose.
(b) COOPERATION.—The Administrator shall cooperate with the Depart-
ment of Agriculture, any cwher Federal agency, and any appropriate agency
of any State or any political subdivision thereof, in carrying out the provi-
sions of thi* Act, and in securing uniformity of regulations.
SEC 23. (Ufa) STATE COOPERATION, AID, AND TRAINING.
(a) COORRATTVB AGREEMENTS.—The Administrator may enter into cooper-
ative agreements with States and Indian tribes—
(1) to delegate to any State or Indian tribe the authority to cooperate
in the enforcement of this Act through the use of its personnel or facili-
ties, to train personnel of the State or Indian tribe to cooperate in the
enforcement of this Act, and to assist States and Indian tribes in imple-
menting cooperative enforcement programs through grants-in-aid; and
(2) to assist States in developing and administering State programs,
and Indian tribes that enter into cooperative agreements, to train and
certify applicators consistent with the standards the Administrator pre-
scribes.
Effective with the fiscal year beginning October 1, 1978, there are author-
ized to be appropriated annually such funds as may bo necessary for the Ad-
ministrator to provide through cooperative agreements an amount equal to SO
percent of the anticipated cost to each State or Indian tribe, as agreed to
under such cooperative agreements, of conducting training and certification
programs during such fiscai year. If funds sufficient to pay SO percent of the
costs for any year are not appropriated, ithe share of etch State and Indian
tribe shall be reduced in a like proportion in allocating available funds.
(b) CONTRACTS FOR TRAINING.—In addition, the Administrator may enter
into contracts with Federal, State, or Indian tribal agencies for die purpose of
encouraging the training of certified applicators.
Pesticides Inspection Manual 2-57 January 1989
-------
Chapter Two Pesticide Law and Definitions
StC.2* _ RFRA _ _ JO
(c) INFORMATION AND EDUCATION.— The Adminisntor sham in coopera-
tion with the Secretary of Agriculture, use the services of the cooperative
State *»t»»ifiofl services to inform flifd *^*?mt* pffflfidf rcnn ft**Hit accepted
uses and omcc regulations nude under dw Act.
SK. M. (UH Aononrr or STATEK.
(a) IN- GBNBRAL*— A. State nay regulate the sate or me of my federally
registered pesticide or device in the Stale, but only if and to the. extent the
regulation does not peanit any sale or use prohihted by this Act
(b) Uraranorr.— Soch State shall noc Jmjpose or continnein Affect any
IwQUuQiHCQIiT' IQT HOttOUf QT VMwEIIDMr Bfc flDQIDOtt 10 OC QUXCVCOt flOOl tfiQSG
mroiTBtt UDDBT tuft ACe»
(C) ADOmONAL USBSd—
(1) A Statt may- provide registration far *•*'«*"'"'' uses of federally
registered pesticides formulated far dtstribottorf sod. use widiin that
Stale to meet tpflr.ial local needs in acconl with the purposes of this Act
and if regisnaoon far soeh use bar not previously been denied, disap-
proved; or canceled by the Administrator. Such registration shall be
deemed registration: under tection J far all pui puses of this Act, but
shall authorize distribution and use only withm sodr State.
(2) A\ registration issoed by a State under thi* snbsectioa shall not be
affective for mam than- ninety
withm that period. Prior u» dUqywai, that Administrsior shag, except
a» provided in paragraph 0) of this subsection, advise tneSaueof the
A»Lunhir'^i r^flyid^
(3) IB no msoDce may & State isne amigisuauon for a food or feed
us* unless thgnr wan? ^ ^U^TW^y y ffflffl^ym IQ mjpfff^ tnA the reasons
therefor and provide the Slate time to respond.
SEC 2£ pMwJ AUTHORrTY OFADMUOSntATOli
(a) IN GENERAL.—
(I) REGULATIONS.^!!* Administrator is authorized in accordance
with die procedure described in paragraph (2), to prescribe regulations
to cany out die provisions of this ACL Such regulations shall take into
account die difference in concept and usage between various classes of
Pesticides Inspection Manual 2-58 January 1989
-------
Chaptcr Two Pesticide Law and Definitions
61 BFBA StC.25
pesticides and differences in environmental risk and the appropriate
data for evaluating: such risk between agricultural and nonagricultural
pesticides.
(2) PROGBDURB. —
(A) PROPOSED REGULATIONS.— At teast 60 days prior to signing
say proposed regulation for publication in the Federal Register, the
Admunstmor shall provide the Secretary of Agriculture with a
copy of such regulation. If tbo Secretary comments in writing to
(he Admnnsntor regarding any such regulation within 30 days
after receiving it, the Adminrmtor shall publish in die Federal
Register (with die proposed regulation) the ««»™*"w of dw Secre-
tary and the response of the ArhninKuam with reganl to the Sec-
retary's comments. If the Secretary does not comment in writing to
the A«fininiqFMor regarding the regulation within 30 days aft«y re-
ceiving it, die Administrator may sign such regulation for publica-
tion in die Federal Register any time after such 30-day period not-
withstanding the foregoing 60-day time requirement
(B) FINAL REGULATIONS.— At least 30 days prior to signing any
regulation in *"*
-------
Chapter Two Pesticide Law and Definitions
Sac. 25 _ RFHA _ 62
tntor shall transmit a copy thereof to the Secretary of the Senate and
the Clerk of the House of Representatives. Hie role or regulation shall
not become effective until the passage of 60 calendar days after the rule
or regulation is so transmitted.
(b) EXEMPTION OF PESTICIDES.— The Adminisuator may exempt from the
requirements of *M* Act by regulation any pesticide which he determines
either (1) to be adequately regulated by another Federal agency, or (2) to be
of a character which is imnnmy » be subject to this Act in order to
cany out the purposes of this Act.
(c) OTHER AUTHORITY.— The Administrator, after notice and opportunity
for hearing, is authorized—
(1) to declare a pest any form of plant or animal lire (other man man
and other thai* bacteria, virus, aixl oner micro-arganisms on or in living
man or other living animals) which is injuiious to health or the environ-
ment;
(2) to determine any pesticide which contains any mbm1*"* or sub-
stances in quantities highly toxic to man;
(3) to establish standards (which shall be consistent with those estab-
lished under the authority of the Poison Prevention Packaging Act
(Public Law 91-601)) with respect to the package, «•»«•«««•, or wrap-
ping in which a pesticide or device w enclosed for use or consumption,
ID QKHST tO TBPOtOCt CiillflTHI 3Du ddlluS TaTHTF SCXIQIIS IfllUnr QT lilDCSS 1C™
suiting from acridmtil ingestioa or contact with pesticides or devices
regulated by this Act as well as to accomplish the other purposes of this
Ace
(4) to specify those classes of devices which shall be subject to any
provision of paragraph 2(qXl) or section 7 of this Act upon his deter-
mination that application of such provision is necessary to effectuate
the purposes of this Act;
(5) to prescribe regulations requiring any pesticide to be colored or
discolored if be determines that such requirement is feasible and is nec-
essary for the protection of health and the environment; and
(6) to determine and establish suitable names to be used in the ingre-
dient statement.
(d) SOENTIPIC ADVISORY PANEL.— The Administrator shall submit to an
advisory panel for comment as to the impact on health and die environment
of the action proposed in notices of intent issued under section 6(b) and of
the proposed and final form of regulations issued under section 2S(a) within
the same time periods as provided fix the cq"™»fW of the Secretary of Ag-
riculture under such sections. The time requirements for notices of intent and
proposed and final forms of regulation may not be nmHifi«d or waived
unless in addition to meeting die requirements of section 6(b) or 25(a), as
failed to
-------
Chapter Two Pesticide Law and Definitions
63 _ RBJA _ Stc.25
the advisory pit**1, after nmiroltariT with the Adminisnuor, may create
temporary nbpands on specific projects to assist the full advisory panel in
expediting and preparing its evaluations, comments, and recommendations.
The sobpanels may be componed of scientists other than members of the ad-
visory paii*>-l't as 4fWfft nn'fiMiy for the purpose of evalnating ^r^fnnfir
saidies relied upon by the Administrator with respect to proposed action.
Such jKMfoT"?1 yrifnrifft «h«n be fflcitPil by the advisory panel The panel
referred to in this subjection shall consist of 7 members appointed by the
Administrator from a ^*n of 12 "f*****"^ 6 tWTi*pyi*<1 by die National Insti-
tmes of Health and 6 by the National Science Foundation, utilizing a system
of staggered w*s of appointment Members- of the panel shall be jelfctfd
on the* basis of their protessionai qual^DcaooDs- 10 assess the eoects of the
impact of pesticides on health and die environment. To die extent feasible to
insure mumdisdplinary representation, die panel membership shall include
from die disciplines of toxicology, pathology, environmental
biology, and related sciences. If a vacancy ocean on the panel due to expi-
ration of a term, resignation, or any other reason, each replacement naignation, or reason other
tfrgit expiration of a term, die Adminiswaor «h»n appoint a member to serve
QIlUDff tD6* QD6XDDQQ fiCnD U^U1^3Off (DO QOOUIUtt&OQ tHOCCSJ SCt iOiTn in UUS
subsection. Should die list of nominees provided under mis subsection be
unsatisfactory, die Administrator may request an additional set of nominees
from die nominating entities The Administrator may require such informa-
tion from die nominees to die advisory panel as he deems necessary, and he
shall publish in die Federal Register die name, address, and professional af-
filiations of each nominee. Each member of die panel shall receive per diem
compensation at a rate not in excess of that fixed for GS-18 of die General
Schedule as may be determined by die Administrator, except that any such
member who holds another office or position under die Federal Government
die compensation for which exceeds such rate may elect to receive compen-
sation at die rate provided for such other office or position in lieu of the
compensation provided by this subsection. In order to assure die objectivity
of die advisory panel, die Administrator shall promulgate regulations regard-
ing conflicts of interest with respect to the members of the panel The advi-
sory panel established under this section shall be permanent. In performing
die functions "ff'gpH by this Act, die panel shall consult and coordinate its
activities with die Science Advisory Board established under die Environ-
mental Research; Development, and Demonstration Authorization Act of
1978. Whenever die Administrator exercises amhority under section 6(c) of
this Act to "»ntv*««*»iy suspend die registration of any pesticide to prevent
an imminent hazard, die Administrator shall promptly submit to die advisory
panel for comment, as to the impact on health and the environment, the
action taken to suspend me registration of such
(e) PEER REVIEW. — The Administrator shall by written procedures, pro-
vide for peer review with respect to the design, protocols, and conduct of
major scientific studies conducted under this Act by the Environmental Pro-
tection Agency or by any other Federal agency, any State or political subdi-
vision thereof, or any institution or individual under grant, contract, or coop-
erative agreement from or with the Environmental Protection Agency. In
such procedures, die Administrator shall also provide for peer review, using
Pesticides Inspection Manual 2-61 January 1989
-------
Chapter Two Pesticide Law and Definitions
S«C. 26 HRU 64
the advisory panel established under subsection (d) of this section or appro-
priate experts appointed by the Administrator from a current list of nominees
ngrintainad by such panel, with respect to the results of any such scientific
studies relied upon by the Admans&aaar_wim respect lo actions the Adminis-
trator may take "****"*g to the change m classification, JHHPMHMII. or can-
cellation of a prfliridf Whenever the Admmiatrator determines >haf cncum-
stances do not permit the peer review of the results of any such scientific
study prior to the Administrator's exercising authority aider section 6(c) of
thi« Act to immediaiely suspend die registration of any pesticide to prevent
an imminent hazard, the Administrator shall promptly thereafter provide for
the conduct of peer review as provided in this sentence, The evaluations and
relevant dumineniation continuing the peer review that reiatB to the pro-
posed scientific studies m*d the results of the cffl*iplftfd tckrfflifvr studies
shall be included in the submission for comment forwarded by die Adminis-
trator ip die advisory panel as provided in subsection (d). As used in this
subsection, die term "peer review" shall mean an independent evaluation by
scientific experts, either widun or outsfde die Environmental Protection
Agency, in die appropriate disciplines.
SBC. 2C. (U*M] STATE PMMAEY ENFORCEMENT RESFONSDILmr.
(a) IN GENERAL. • For the purposes of diis Act, a State shall have primary
enforcement responsibility for pesticide use violations during any period for
which die AHmtni^r^tpy rlftvmimfq that jflfh Stale——
(1) has adopted adequate pesticide use laws and regulations, except
that the A/hniniiHffinr may not require a State to have pesticide use
laws that are more stringent than this Act;
(2) has adopted and is implementing adequate, procedures for die en-
forcement of such State laws and regulations; and
(3) win keep such records and make such reports showing compli-
ance with paragraphs (1) and (2) of mis subsection as die Administrator
may require by regulation.
(b) SKOAL RULES.—Notwimstanrtng die provisions of subsection (a) of
this section, any State that enters into a cooperative agreement with the Ad-
minisaator under section 23 of this Act for the enforcement of pesticide use
lesuiUjuus shall have die primary enforcement iMoonsibility for pesticide
use violations. Any State that has a plan approved by die Administrator in
accordance with die requirements of section 11 of this Act tittt die Adminis-
trator determines meets die criteria set out in subsection (a) of this section
shall have die primary enforcement responsibility for pesticide use viola-
tions. The Administrator shall make soch determinations with respect to
Sute plans under section 11 of mis Act in effect on die date of enactment of
die Federal Pesticide Act of 1978 [September 30. 1978] not later than six
months after diat date.
(c) ADMINBTTIATOR.—The Administrator shall have primary enforcement
responsibility for those States that do not have primary enforcement respon-
sibility under mis Act Not withstanding the provisions of section 2(e)(l) of
this Act, during any period when me Administrator has soch enforcement
responsibility, section 8(b) of dus Act shall apply to die books and records
of commercial applicators and to any applicator who holds or applies pesti-
cides, or use dilutions of pesticides, only to provide a service of controlling
pests without delivering any unapplied pesticide to any person so served,
and section 9(a) of this Act shall apply to die establishment or other place
where pesticides or devices are held for application by such persons with
lespect to pesticides or devices held for such application.
Pesticides Inspection Manual 2-62 January 1989
-------
Chapter Two Pesticide Law and Definitions
65 FffRA StC. 31
SEC 27. [lMw-2] FAILURE BY THE SPATE TO ASSURE ENFORCEMENT OF
STATE PESTICIDE USE REGULATIONS.
(a) REFERRAL.— Upon receipt of any complaint or other information alleg-
IDff flf IDBiGSttnff S> StflBlflCSBt VIQiSOOD OK tflS DCSDCloO QSe PfOViSttttS 01 tuIS'
Act* the AdflnMBMor shall refer the IOTHTT to ttas appropnate State »ffjpiai«
for their mvesngsoon of tbe owner consismt widi the requirements of this
Act If, within thirty days, the Sisss has not commenced appropriate enforce-
ment action, the Aihiiiiiiiuiauji may act upon the complaint or information to
the extent authorized under this Act.
(b) NOIIITI WhfBovff the Adminutraior dfliniiiimes that a State having
primary enforcement responsibility for pesticide use violations is not cany-
ing out (or cannot cany out doe ID the lack of •<**T'*** legal authority) such
responsibility, the Administrator shall notify die State. Such nonce shall
SD6CUY tiHMB 8SD6CQ Of tu6 fiuOmUSffcaftOO of tDB St&tO DIOfltVB uMt flVB QC*
tennined to be inadequate. The State shall have ninety days after receipt of
die notice to comm any dffirifnci?Si If after ***** time the Administrator
that ing State ifMwv11 remains 'rv\^f\"atf. die
may rescind, in whole or in pan, die Sena's primary enforcement responsi-
bility for pesticide use violations.
(c) CoMSTmcnoN.-~Netther section 26 of this Act nor this sotiiuu shall
limit die authority of tbe Administrator to enforce this Act, where die Ad-
minismuor determines dot emergency conditions exist that require immedi-
ate action on die pan of die Admmsmor and die State authority is unwill-
ing or unable adequately to respond to tbe emergency.
SEC 28. [LMw3] IDENTIFICATION OF PESTS; COOPERATION WITH DEPART-
MENT OF AGRICULTURE'S PROGRAM.
The Administrator, in CTqrrtfoatfoq witn die Secretary of Agriculture, shall
identify those pests that must be brought under control. Tbe Administrator
shall also coordinate! and cooperate with the Secretary of Agriculture's re-
search and implementation imUfi HIT'S t° develop and improve the safe use
and effectiveness of chemical, biological, and alternative mernods to combat
and control pests that reduce die quality and economical production and dis-
tribution of agricultural products to domestic and foreign consumers.
SEC 29. [13*iM] ANNUAL REPORT.
The Adrninisuatur shall submit an gifnai lepctl to Congress before Feb-
ruary 16 of each year and die first report shall be due February IS, 1979.
Tbe report shall include the total number of applications for conditional reg-
istration under sections 3(c)C7XB) and 3(cX7XQ of this Act that were filed
during the immediately preceding fiscal year, and, witb respect to diose ap-
plications muMuvffd, die A/tmmimi'aiirn' ghaii igpon the A4it>"*'f>">>nr' * find-
ings in *ach »*ay, die rf|*"*'t'flf
-------
Chapter Two Pesticide Law and Definitions
S«C. 31 RFRA
(1) $83,000,000 for fiscal year 1989, of which not more dan
$13,735,500 shall be available for research under this Ace
(2) $95,000,000 for fiscal year 1990, of which not more than
514,343,600 shall be available for research under mis Ace and
(3) $95,000400 for fiscal year 1991, of which not more man
$14,978,200 shall be available fat research under mis ACL
Pesticides Inspection Manual 2-64 January 1989
-------
Chapter Two Pesticide Law and Definitions
STATUTORY AUTHORITY FOR PESTICIDE REGULATION
Under FIFRA, pesticide products must be registered by the EPA before they are sold or
distributed in commerce. The 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, in making these decisions, to take into
account economic, social, and environmental costs and benefits. FIFRA was first passed in 1947.
Thousands of pesticide products have been registered since.
To ensure that previously registered pesticides meet current scientific and regulatory standards,
in 1972 Congress amended FIFRA to require the "reregistration" of all existing pesticides. This is a
massive undertaking.
FIFRA authorizes 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. Under FIFRA, EPA
was required to accept suspended and cancelled pesticides and dispose of them at government
expense. In addition, an indemnification provision required EPA to reimburse holders of suspended
and cancelled pesticides for any loss suffered, up to the cost of the pesticide.
FIFRA AMENDMENTS OF 1988
On October 25, 1988, an act to amend FIFRA (1988 Amendments) became law, after passing
both the Senate and House of Representatives unanimously. The 1988 Amendments strengthen
EPA's authority in several major areas, requiring a substantial acceleration of the pesticide
reregistration activity, imposing statutory time limits for processing certain types of pesticide
registration activities, and changing EPA's responsibilities and funding requirements for the
indemnification, storage, and disposal of suspended/cancelled pesticides. It also authorizes
collection of fees to support some of these new activities.
Pesticides Inspection Manual 2-65 January 1989
-------
Chapter Two Pesticide Law and Definitions
DEFINITIONS
Act. When used in this manual, the term, Act means the Federal Insecticide, Fungicide, and Rodenti-
cide Act, as amended (FIFRA).
Active Ingredient. The term means:
o In the case of a pesticide other than a plant regulator, defoliant, or desiccant, an ingredient
that will prevent, destroy, repel, or mitigate any pest;
o In the case of a plant regulator, an ingredient that, through physiological or biochemical
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;
o In the case of a defoliant, an ingredient that will cause the leaves or foliage to drop from a
plant; or
o In the case of a desiccant, an ingredient that will artificially accelerate the drying of plant
tissue.
Acute Dermal Lethal Dose-50 (LD-50). A single, dermally administered dose of a substance, ex-
pressed as milligrams per kilogram of body weight, that would be lethal to 50 percent of the test
population of animals within a specified time period and under specified test conditions, as
prescribed in the Registration Guidelines.
Acute Lethal Concentration-50 (LC-50). A concentration of a substance, expressed as parts per
million 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.
Acute Oral LD-50. A single, orally administered dose of a substance, expressed as milligrams per
kilogram of body weight, that would be lethal to 50 percent of the test population of animals
under specified test conditions as prescribed in the Registration Guidelines.
Administrator. The Administrator of the United States Environmental Protection Agency.
Adulterated. Any pesticide meeting one or more of the following conditions:
o Its strength or purity falls below the professed standard of quality as expressed on the
labeling under which it is sold;
o Any substance has been substituted wholly or in part for the pesticide; or
o Any valuable constituent of the pesticide has been wholly or partly abstracted.
Advertising. Promotional materials, either printed or broadcasted through air or visual media,
intended to enhance customer sales. These materials do not accompany the pesticide product at
any time in the normal distribution and sale of the product and, therefore, are not considered
part of the pesticide labeling.
Affidavit. A written statement made under oath before a notary public or other person authorized to
administer oaths.
Agency. The United States Environmental Protection Agency.
Pesticides Inspection Manual 2-66 January 1989
-------
Chapter Two Pesticide Law and Definitions
Animal. All vertebrate and invertebrate species, including but not limited to man and other mam-
mals, birds, fish, and shellfish.
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 inver-
tebrate animals declared to be pests. This does not include, however, substances intended for
survey or detection purposes only.
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 deter-
mined by the producer.
Bin Labels. Stock supply of labels that have not been affixed to the product containers.
Books and Records. All records required pursuant to Sections 8 and 9 of the Act and 40 CFR Part
169.2 of the Regulations, as well as all records in lieu thereof.
Bulk Pesticide. Any amount of pesticide greater than 55 gallons (liquid) or 100 pounds (solid) held in
any individual container.
Cancellation. The Administer may cancel or change the classification of 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 (Section
6 of FIFRA).
Carcinogenic. The property of a substance or a mixture of substances that causes cancer.
Certified Applicator. Any individual who is certified under Section 11 as authorized to use or
supervise use of any pesticide that is classified for restricted use.
Chemigation. The application of pesticide products registered under FIFRA and applied through
irrigation systems.
Commercial Applicator. An applicator (whether or not he/she is a private applicator with respect to
some uses) who uses or supervises the use of any pesticide that is classified for restricted use
for any purpose or on any property other than as provided under the term of private applicator.
Complainant. The Agency acting through any person authorized by the Regional Administrator to
issue a complaint to persons alleged to be in violation of the Act.
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 coopera-
tor.
Custom Blend. A mixture of pesticide and another compound (usually herbicides with fertilizers),
which is prepared to the order of the end user and not held in inventory.
Custom Blender. Any pesticide-producing establishment whose production is totally confined to
custom blend products.
Defoliant. Any substance or mixture of substances intended for causing leaves or foliage to drop from
a plant, with or without causing abscission.
Pesticides Inspection Manual 2-67 January 1989
-------
Chapter Two Pesticide Law and Definitions
Degradation Product. A substance resulting from the transformation of a pesticide by physical,
chemical, or electromagnetic means.
Desiccant. Any substances or mixture of substances intended for artificially accelerating the drying of
plant tissue.
Device. Any instrument or contrivance (other than a firearm) that is intended to trap, destroy, repel,
or mitigate any pest or 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).
Distributor Label. 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.
Domestic Application. Application of a pesticide directly to humans or pets, or application of a
pesticide in, on, or around all structures, vehicles, or areas associated with the household or
home life, patient-care areas of health-related institutions, or areas where children spend time
including but not limited to:
(1) Gardens, noncommercial greenhouses, yards, patios, houses, pleasure marine craft, mobile
homes, campers and recreational vehicles, noncommercial campsites, home swimming
pools, and kennels;
(2) Articles, objects, devices or surfaces handled or contacted by humans or pets in all struc-
tures, vehicles, or areas listed above;
(3) Patient-care areas of nursing homes, mental institutions, hospitals, and convalescent
homes; and
(4) Educational, lounging and recreational areas of preschools, nurseries, and day camps.
Drift. Movement of a pesticide during or immediately after application or use through air to a site
other than the intended site of application or use.
Emergency Exemption. Special exemption to registration allowed under provisions of Section 18, that
permits limited use of a pesticide specifically intended to address an emergency condition.
Environment. The air, water, land, all plants, man, and other animals living therein, and the inter-
relationships that exist among these.
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.
Establishment. Any place where a pesticide or device or active ingredient used in producing a pesti-
cide is produced or held for distribution or sale (i.e., producer establishment [PE], marketplace
establishment [ME], or distributor).
Experimental-Use Permit (EUP). A permit granted by EPA to an applicant desiring to conduct
research to accumulate information necessary to register a pesticide under Section 5. Research
programs encompassing fewer than ten acres are generally exempted from permit
requirements.
Fungus. Any nonchlorophyll-bearing thallophyte (that is, any nonchlorophyll-bearing plant of a lower
order than mosses and liverworts); for example, rust, smut, mildew, mold, yeast, and bacteria,
Pesticides Inspection Manual 2-68 January 1989
-------
Chapter Two Pesticide Law and Definitions
except those on or in man or other animals and those on or in processed food, beverages, or
Pharmaceuticals.
Imminent Hazard. A situation that exists when the continued use of a pesticide during the time
required for a cancellation proceeding would likely result in unreasonable adverse effects on
the environment or will involve unreasonable hazard to the survival of a species declared
endangered by the Secretary of the Interior under Public Law 91-135.
Inconsistent Pesticide Use. To use any registered pesticide in a manner not permitted by the labeling.
(Refer to Section 2ee of the act for exceptions.)
Inert Ingredient. An ingredient that is not active.
Ingredient Statement. A statement that contains (1) the name and percentage of each active ingre-
dient, and the total percentage of each active ingredient, and the total percentage of all inert
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.
Insect. 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 (for example, beetles, bugs, bees, flies) and other allied classes of arthro-
pods whose members are wingless and usually have more than six legs (for example, spiders,
mites, ticks, centipedes, and wood lice.)
Inspector. Any officer or employee of the Environmental Protection Agency or of any state 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 Investi-
gation Officer, or Compliance Officer.
Label. The written, printed, or graphic matter on or attached to the pesticide or device or any of its
containers or wrappers.
Labeling. All labels and all other written, printed, or graphic matter accompanying the pesticide or
device at any time or to which reference is made on the label or in literature accompanying the
pesticide or device [for exceptions, see Section 2(p)(2)(B) of the Act].
Market Place. All places, which may also include production sites, where pesticides or devices are
held for distribution or sale.
Misbranded. Any pesticide not displaying a proper label or whose label contains false or misleading
information. See Section 2(p) of the Act for a description of a proper label and exceptions.
Mutagenic. The property of a substance or mixture of substances that induces genetic or somatic
changes in subsequent generations.
Nematode. Invertebrate animals of the phylum nemathelminthes and class nematoda (that is, unseg-
mented roundworms with elongated, fusiform, or saclike bodies covered with cuticle, and inhabiting
soil, water, plants, or plant parts); may also be called nemas or eelworms.
Nontarget Organism. Those flora and fauna (including humans) that are not intended to be con-
trolled, killed, or detrimentally affected in any way by a pesticide.
Pesticides Inspection Manual 2-69 January 1989
-------
Chapter Two Pesticide Law and Definitions
Oncogenic. The property of a substance or mixture of substances that produces or incites tumor
formations in living tissues.
Packaged, Labeled, and Released for Shipment. 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.
Participant. 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.
Permittee. Any applicant to whom an experimental-use permit has been granted.
Person. Any individual, partnership, association, corporation, and any organized group of persons
whether incorporated or not.
Pest. Any insect, rodent, nematode, fungus, weed, or other form of terrestrial or aquatic plant or
animal life, or virus, bacteria, or other microorganism (except viruses, bacteria, or other
microorganisms on or living in man or other living animals) that the Administrator declares to
be a pest under Section 25(c)(l).
Pesticide. Any substance or mixture of substances that is intended to prevent, destroy, repel, or
mitigate any pest or is intended for use as a plant regulator, defoliant, or desiccant (see Section
2(u) for exceptions).
Pesticide Application. The placement for effect of a pesticide at or on the site where the pest control
or other response is desired.
Pesticide Formulation. The substance or mixture of substances comprising all active and inert (if any)
ingredients of a pesticide product.
Pesticide-Producing Establishment. Any establishment registered with the Administrator that
produces a pesticide, or an active ingredient used in a pesticide subject to this Act.
Pesticide Product. A pesticide offered for distribution and use and includes any labeled container and
any supplemental labeling.
Pesticide Use. Any act of handling or release of a pesticide or exposure of humans or the
environment to a pesticide through acts, including but not limited to the following:
(1) Application of a pesticide, including mixing and loading and any required supervisory
action in or near the area of application.
(2) Storage actions for pesticides and pesticide containers; and
(3) Disposal actions for pesticides and pesticide containers.
[Use, as defined here, incorporates application. However, the certification requirement for
certain restricted-use pesticides only applies with respect to applications of such pesticides.
Many aspects of use do not include application (e.g., storage, transportation) and, hence, are
outside the requirement for certification.]
Pheromonc. A sensory stimulant attractant used to draw certain animals into traps or away from crop
sites; considered to be an active ingredient in pesticide products.
Pesticides Inspection Manual 2-70 January 1989
-------
Chapter Two Pesticide Law and Definitions
Phytotoxicity. Poisonous to plants.
Plant Regulator. Any substance or mixture of substances intended, through physiological action, for
accelerating or retarding the rate of growth or the rate of maturation, or for otherwise altering
the behavior of plants or the product thereof, but shall not include substances to the extent that
they are intended as plant nutrients, trace elements, nutritional chemicals, plant inoculants, and
soil amendments. See Section 2(v) of the Act for additional exceptions.
Primary Enforcement Responsibility. The first (or primary) option for investigating and taking
appropriate enforcement action against pesticide use violations.
Private Applicator. A certified applicator who uses or supervises the use of any pesticide that is
classified for restricted use for purposes of producing any agricultural commodity on property
owned or rented by him/her or his/her employer or (if applied without compensation other
than trading of personal services between producers of agricultural commodities) on the
property of another person.
Produce. Manufacture, prepare, compound, propagate, package, label, or process any pesticide or
device or active ingredient used in producing a pesticide.
Protect Health and the Environment. The terms "protect health and the environment" and "protection
of health and the environment" mean protection against any unreasonable adverse effects on
the environment.
Reentry. The action of entering an area or site at, in, or on which a pesticide has been applied.
Registrant. A person who has registered any pesticide pursuant to the provisions of this Act.
Registration of Pesticides. The requirement of any person to register with the Administrator any
pesticides that they distribute, sell, offer for sale, hold for sale, or ship or deliver for shipment
in the U.S.
Residue. The active ingredient(s), metabolite(s), 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.
Special Local Need (SLN). If necessary, a state may provide for additional uses of federally regis-
tered pesticides formulated for distribution and use within that state to meet special local needs
in accordance with the purposes of this Act and if registration for such use has not been previ-
ously denied, disapproved, or cancelled by the Administrator [see FIFRA Section 24(c)(l)].
State. 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. 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 ex-
pedited hearing.
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.
Toxicity. The property of a substance or a mixture of substances to cause any adverse effects.
Pesticides Inspection Manual 2-71 January 1989
-------
Chapter Two Pesticide Law and Definitions
Unreasonable Adverse Effects. 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.
Use Dilution. A dilution specified on the label or labeling that produces the 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:
(1) Target pest;
(2) Crop or animals treated;
(3) Application site; and
(4) Application technique, rate, and frequency.
Violation. Any act that constitutes a violation of law as cited in FIFRA Section 12 "Unlawful Acts", or
pertinent state legislation.
Weed. Any plant that grows where it is not wanted.
Pesticides Inspection Manual 2-72 January 1989
-------
Registration
-------
Chapter Three
REGISTRATION
Page No.
PESTICIDE REGISTRATION 1
Amendments of 1988 1
Background on FIFRA 1
REGISTRATION PROCEDURES 3
New Registrations (40 CFR, Section 162.6(b)(2)) 3
Amended Registrations (40 CFR, Section 162.6(b)(3)) 3
Supplemental Registrations (40 CFR, Part 162.6(b)(4) and 162.43(e)) 3
Section 24(C) Registrations (40 CFR, Sections 162.150 - 162.156) 4
Pesticides Inspection Manual 3-i January 1989
-------
Chapter Three Registration
Pesticides Inspection Manual 3-ii January 1989
-------
Chapter Three
REGISTRATION
PESTICIDE REGISTRATION
Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act states that no unregistered
pesticide may be sold or distributed, unless exempted by Section 3(b). The Code of Federal
Regulations 40, Parts 152 to 167, establishes the requirements for product registration.
Amendments of 1988
On October 25, 1988, the President signed into law the FIFRA Amendments of 1988. The 1988
Amendments to FIFRA, which govern the regulation of pesticides in the U.S., strengthen EPA's
authority in several major areas. Among other things, the amendments require a substantial accelera-
tion of the reregistration process for previously registered pesticides and authorize the collection of
fees to support reregistration activities. The law also changes EPA's responsibility and funding
requirements for the storage and disposal of suspended and cancelled pesticides and the indemnifica-
tion of holders of remaining stocks of such cancelled pesticides. The major provisions of the new law
are effective on December 24,1988.
Background on FIFRA
Under FIFRA, all pesticides must be registered (licensed) by EPA before they may be sold or
distributed in commerce. FIFRA sets an overall risk/benefit standard for pesticide registration,
requiring the pesticides perform their intended function, when used according to labeling directions,
without posing unreasonable risks of adverse effects on human health or the environment. In making
pesticide registration decisions, EPA is required by law to take into account the economic, social and
environmental costs and benefits of pesticide uses.
FIFRA was first enacted in 1947. Thousands of pesticide products have been registered since
then. However, the standards for pesticide registration have not remained the same since 1947, but
have evolved in tandem with science and public policy. In particular, test data requirements for
pesticides have become increasingly stringent in light of advances in such areas as toxicology and
analytical chemistry. Under FIFRA, pesticide registrants (companies that hold pesticide registra-
tions) are responsible for providing 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 "reregistration" of all existing pesticides. This has proved
to be a massive undertaking. A combination of factors has impeded the Agency's progress in carrying
out the reregistration mandate, including inadequate resources and the sheer magnitude of the task.
Of the approximately 600 pesticide active ingredients that require reregistration under FIFRA, EPA
has issued "Registration Standards" for about 185. A Registration Standard includes a comprehensive
Pesticides Inspection Manual 3-1 January 1989
-------
Chapter Three Registration
review of all the available data on the chemical, a list of additional data needed for a complete
reevaluation and reregistration, and the Agency's current regulatory position on the pesticide.
FIFRA authorizes EPA to cancel the registration of an existing pesticide if test data show that it
causes unreasonable adverse effects on human health or the environment. In addition, under certain
circumstances, EPA may take action to suspend the registration of a pesticide to prevent an imminent
hazard.
The Registration Division, Office of Pesticide Programs, undertakes pesticide registration and
review to determine whether registration is necessary. The Registration Division also reviews labels
obtained during inspections to determine whether they meet the labeling requirements.
A product must be registered if the following conditions exist:
o A product meets the definition of a pesticide under 40 CFR, Part 162.3(ff);
o The product's labeling and other material make pesticidal claims; or
o A product is represented in any manner that results in its being used as a pesticide.
Certain products do not meet these criteria and are not considered to be pesticides (162.4(c)):
o Deodorizers, bleaching agents, and cleaning agents for which no pesticidal claims are
made;
o Paint and other formulated coatings that are treated with fungicides to protect the coating
itself and which bear no pesticidal claims;
o Building material products, such as, lumber and caulking material that have been treated
to protect the material itself against pests and for which no pesticidal claims are made as to
protection of other surfaces;
o Fabric products that have been treated to protect the fabric itself from pests; and
o Fertilizer, soil amendment, other plant nutrients.
Other products are considered to be pesticide products but are exempt from registration
(162.5(b)):
o Pesticides that are transferred, sold, or distributed as follows:
From one registered establishment to another registered establishment operated by
the same producer, solely for packaging at the second establishment or for use as a
constituent part of another pesticide produced at the second establishment (40 CFR,
Part 162.5(b)(l);
For use in accordance with an experimental-use permit (40 CFR, Part 172);
From one port-of-entry to another port-of-entry under a U.S. Customs Transportation
and Exportation Bond;
From registrant to unrelated contractual manufacturer operating under contractual
manufacturing agreement provided the transferor produces the pesticide and holds
the registration for the final product; and
Pesticides Inspection Manual 3^2 January 1989
-------
Chapter Three Registration
Under contract between two unrelated registered establishments where either the
transferor possesses the end product or where the constitutent or intermediate
ingredients are from registered source pesticides.
o For use in accordance with the terms of an emergency exemption (40 CFR, Part 166);
-- Pesticides shipped solely for disposal (40 CFR, Part 162.5(b)(3);
Pesticide products intended for export when packaged according to the directions of
the foreign purchaser;
Pheromones when used as the sole active ingredient in a trap;
Pesticide devices that contain no active ingredient; and
Custom blends that are formulated expressly for the end user and are not held in
inventory.
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.
REGISTRATION PROCEDURES
All applications for product registration (devices need not be registered) are to be submitted to
the Registration Division, Office of Pesticide Programs. Application procedures for registering a
pesticide are codified in 40 CFR, Parts 162.1 through 162.177. FIFRA provides for several types of
pesticide registrations: new, amended, supplemental, reregistration, renewal, and Section 24(c)
registrations.
New Registrations (40 CFR, Section 162.6(b)(2))
An application for new registration must be submitted to the Administrator.
Amended Registrations (40 CFR, Section 162.6(b)(3))
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.
Supplemental Registrations (40 CFR, Sections 162.6(b)(4) and 162.43(e))
A registered product can be supplementally registered (also known as private labels), which
allows a distributor to market the product under his/her own brand name. However, the following
conditions must be met:
o 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 152.30);
Pesticides Inspection Manual 3-3 January 1989
-------
Chapter Three Registration
o The product labeling must bear the same claims as the primary product provided. How-
ever, specific claims may be deleted if, by so doing, no other changes are required;
o The product must remain in the producer's unbroken container;
o The label must bear the registration number of the primary registered product;
o The distributor's company number must appear as a suffix to the registration number; and
o Distributor products may bear the name and address of the distributor.
The registrant must submit the following information:
o Application for Supplemental Registration of Distributor (EPA Form 8570-5);
o Letter or other proof of concurrence by the distributor; and
o Distributor's company number.
Section 24(C) Registrations (40 CFR, Sections 162.150 - 162.156)
Under this section, states may register a federally registered product for additional uses if a
special local need exists. In such cases, the state assigns a special local need registration number to
the product and notifies the Agency within 10 days. The agency, in turn, issues a Federal Register
notice announcing the change in registration.
Pesticides Inspection Manual 3-4 January 1989
-------
Federal/State Cooperation
-------
Chapter Four
FEDERAL/STATE COOPERATION
AUTHORITY 1
Cooperative Enforcement Agreements , 1
State Primacy 1
Referral Procedures Under FIFRA Sections 26 and 27 1
Inspectional Authority 2
Inspections When the State Has Primacy 2
Nonprimacy Inspections 2
State Authority 2
Federal Authority 2
BACKGROUND 2
RESPONSIBILITY 3
Environmental Protection Agency 3
States 3
Pesticides Inspection Manual 4-i January 1989
-------
Chapter Four ^ Federal/State Cooperation
Pesticides Inspection Manual 4-ii January 1989
-------
Chapter Four
FEDERAL/STATE 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 and Indian tribes to
(1) delegate the authority to cooperate in the enforcement of FIFRA and (2) assist the states and
Indian tribes in training and certifying pesticide applicators.
State Primacy
Sections 26 and 27 of FIFRA, as amended, (1) set forth the conditions under which states may
receive primary enforcement responsibility for pesticide use violations and (2) authorize the Adminis-
trator to override or rescind a grant of primacy in certain situations. On January 5, 1983, EPA pub-
lished 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 is found in 40 C.F.R. Part 173.
A state may obtain primary enforcement responsibility for pesticide use violations in one of two
ways (1) by demonstrating that it has adopted and implemented adequate procedures for enforcing
pesticide use laws and regulations or (2) by entering into a cooperative agreement with EPA for the
enforcement of pesticide use restrictions.
Referral Procedures Under FIFRA Sections 26 and 27
Section 27(a) 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 Interpre-
tive 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 environ-
ment. The priority areas will be revised on an annual basis based upon the effectiveness of the pro-
grams in reducing the harm associated with pesticide use in the state. The negotiated written agree-
ment between the state and the Region will contain the criteria for the selection of significant pesti-
cide use cases.
All pesticide use cases that are 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.
Pesticides Inspection Manual 4-1 January 1989
-------
Chapter Four Federal/State Cooperation
An investigation 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 investigation, discuss the reasons for EPA's determination that the action is inadequate,
and state that the EPA will initiate its own enforcement action.
Inspcctional 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 guidelines should be used in determining whether to use Federal or state creden-
tials. The inspector should never use both state and Federal authority for the same inspection.
Inspections When the State Has Use Primacy
State inspectors must always use state authority, state credentials, state forms, and state proce-
dures when conducting use inspections where the state has primacy.
Nonprimacy Inspections
State Authority. State inspectors should 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 should use Federal authority, Federal credentials, Federal
forms, and Federal procedures when conducting inspections for which the state does not have author-
ity, but which are authorized by FIFRA.
BACKGROUND
The Cooperative Enforcement Agreement Program establishes a working partnership between
EPA and the states for the cooperative enforcement of both Federal and state pesticide laws and
regulations. The following lists some of the primary objectives of this partnership:
o Improve coordination of the Federal and state pesticide enforcement program;
o Minimize duplication of effort;
o Improve targeting of resources by tailoring the program to meet the local needs and
concerns of each state; and
o Provide more efficient use of resources through the use of state offices and personnel.
Pesticides Inspection Manual 4-2 January 1989
-------
Chapter Four Federal/State Cooperation
RESPONSIBILITY
Both the EPA and the states perform different roles in the Cooperative Enforcement Agree-
ment Program. Some areas of responsibility are listed below:
Environmental Protection Agency
o Provide Federal funding to assist the states through cooperative agreements;
o Provide national focus and oversight to the program;
o Provide national guidance, enforcement strategies, and policies;
o Provide training for state personnel;
o Delegate authority to states and provide Federal credentials for state inspectors to conduct
inspections where state authority is lacking; and
o Initiate Federal civil and criminal enforcement actions for violations of FIFRA that are
referred to EPA by the states.
States
o Provide a share of the funding for the Cooperative Enforcement Agreement Program;
o Assist EPA in developing national guidance, enforcement strategies, and policies;
o Ensure compliance with both Federal and state pesticide laws by conducting an inspection
and sampling program;
o Initiate state enforcement actions for violations of state laws; and
o Refer fully documented cases of violations of FIFRA to EPA for Federal civil or criminal
enforcement action.
Pesticides Inspection Manual 4-3 January 1989
-------
Chapter Four ^ Federal/State Cooperation
Pesticides Inspection Manual 4-4 January 1989
-------
Experimental Use Permit
Investigation
-------
Chapter Five
EXPERIMENTAL-USE PERMIT INVESTIGATIONS
Page No.
AUTHORITY 1
Unlawful Acts 1
OBJECTIVES
RESPONSIBILITY 2
Registration Division, OPP, EPA 2
EPA Regional Offices 2
CONDUCTING THE EUP INVESTIGATION 3
Adverse Effects 3
REPORTING 3
Pesticides Inspection Manual 5-i January 1989
-------
Chapter Five Experimental-Use Permit Investigations
Pesticides Inspection Manual S-u January 1989
-------
Chapter Five
EXPERIMENTAL-USE PERMIT INVESTIGATIONS
AUTHORITY
Section 5 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, and
40 CFR Part 172 of the Regulations (Experimental Use Permits) authorizes experimental-use permit
investigation.
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.
After publication of regulations under Section 5 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)(H), 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 adequate to avoid unreasonable adverse effects on the environment; and
(2) determine whether the terms and conditions of the permit are being met.
Pesticides Inspection Manual 5-1 January 1989
-------
Chapter Five Experimental-Use Permit Investigations
RESPONSIBILITY
Registration Division, OPP, EPA
The Registration Division reviews and evaluates applications for experimental use permits and
approves, issues, or disapproves such permits. The Registration Division also has the responsibility
and final authority to take such action as is necessary to modify or revoke a permit, if warranted.
The Registration Division will furnish a copy of each EUP, the accepted label, names of the
participants, and terms of the program to the region in which the pesticide shipment originates and
the region in which testing occurs.
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 Investigations. Procedures will be the same as for EPA unless modified by grant
agreements or Regional Policy.) However, 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 oversurveillance of
widely distributed experimental chemicals.
Each regional office will establish its own supervision schedule based on the following list of
priorities:
o Permits for pesticides that are completely new classes of compounds (e.g., juvenile
hormones);
o Permits for chemicals with special potential hazard to humans or the environment, such as:
highly toxic products,
products with propensity to drift,
products with high terrestrial or aquatic mobility, and
products of a particularly persistent nature;
o Permits for chemicals with previously registered uses that were subject to adverse action
by EPA;
o Permits for chemicals manufactured by companies that have a history of noncompliance,
inadequate supervision, or other indications of problems;
o Permits for those chemicals that may ultimately have a widespread major use (e.g., chemi-
cals that will replace a major pesticide which has been cancelled by the Agency); and
o Any other permits for which the Registration Division or the Office of Compliance Mon-
itoring requests special information.
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
Pesticides Inspection Manual 5^2 January 1989
-------
Chapter Five Experimental-Use Permit Investigations
program such as dates, times, sites, etc. Such persons would include sales representatives and field
representatives. In addition, the regional office or state may contact the permitee for additional
details regarding the program if necessary to expedite the monitoring of the permit.
CONDUCTING THE EUP INVESTIGATION
Obtain a copy of the specific EUP and accepted label in question. Review and become familiar
with the requirements of the EUP. Take a copy of the EUP and label on the inspection for reference.
The following items should be checked for compliance with the provisions of the permit in addition to
any specific instructions issued by the regional office:
o The labels on the containers should be the same as the accepted label.
o The product should be applied in accordance with the label directions, precautions, and
terms of the permit.
o The permittee should be supervising the testing activities of participants, evaluating the
results and reporting any adverse effects to EPA.
o The amount of pesticide sold or provided.
o The quantities of product shipped and/or received.
o The shipments have been made to designated participants only.
o The disposition of food or feed that is not covered by a tolerance.
o The disposition of the unused pesticide in accordance with permit instructions.
In certain instances, follow-up may be required (e.g., to verify (1) crop rotation, (2) crop
destruction, (3) grazing restrictions, etc.).
Adverse Effects
The following adverse effects should be documented:
o Accidents
o Animal kills (domestic or wild)
o Phytotoxicity (to target or from drift)
o Other complaints
REPORTING
The inspector must submit a written report to the regional office (or state office, if appro-
priate) on all permits monitored. This report must cover all items previously mentioned in addition to
any points requested by the regional office.
Pesticides Inspection Manual 5-3 January 1989
-------
Chapter Five Experimental-Use Permit Investigations
If it appears that the terms of the permit have been violated, the inspector must document
evidence to prove the violation. Photographs, affidavits, and samples showing the manner in which
the terms of the permit are being violated should be obtained. Physical samples should not be col-
lected except when advised by the region to do so. The inspector should report any violation, via
telephone, to the regional or state office to determine what follow-up action may be required.
Pesticides Inspection Manual 5-4 January 1989
-------
Cancellation and
Suspension
-------
Chapter Six
CANCELLATION AND SUSPENSION
Page No.
AUTHORITY 1
Cancellation 1
Suspension 1
Unlawful Acts 1
OBJECTIVE 2
POLICY 2
GENERAL 2
PROCEDURES 2
Producer Establishment Inspections 2
Marketplace Inspections 2
Use Inspections 3
Storage and Disposal of Suspended or Cancelled Pesticides 3
Indemnity Payments 3
Pesticides Inspection Manual 6-i January 1989
-------
Chapter Six Cancellation and Suspension
Pesticides Inspection Manual 6-ii January 1989
-------
Chapter Six
CANCELLATION AND SUSPENSION
AUTHORITY
Section 6 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) provides the
Administrator the authority to cancel and/or suspend the registration of a pesticide.
Cancellation
The Administrator must cancel the registration of a pesticide at the end of 5 years unless the
registrant (or other interested party acting with the registrant's concurrence) requests renewal of the
registration before the end of the 5 years.
The Administrator may issue a Notice of Intent 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 un-
reasonable adverse effects on the environment.
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, he/she may order imme-
diate suspension of the pesticide's registration. Suspension can be accomplished in two ways under
Section 6(c).
The Administrator is required to give the registrant prior notice before issuing a suspension
order (ordinary suspension). However, the Administrator may issue a suspension order without
notice whenever he/she determines the existence of an emergency situation that would not allow
enough time to hold a hearing [see Section 6(c)(3)] (emergency suspension).
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 of
registration of a pesticide under Section 6.
Pesticides Inspection Manual 6-1 January 1989
-------
Chapter Six Cancellation and Suspension
OBJECTIVE
To determine compliance with the Administrator's orders concerning suspended and/or can-
celled products.
POLICY
It is the policy of EPA to follow-up all suspension and/or cancellation orders with appropriate
surveillance and regulatory action, as dictated by the nature of the order. Compliance monitoring
strategies may be developed for each suspension and/or cancellation order.
GENERAL
Cancelled pesticides in the channels of 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.
However, the Administrator may, under special circumstances, permit the sale or use of existing
stocks.
The inspector must be familiar with the terms of the order.
PROCEDURES
Producer Establishment Inspections
If cancelled or suspended pesticides are discovered during a producer establishment inspection,
the inspector should take the following steps:
o If production of a cancelled or suspended product is encountered, this information should
be immediately brought to the attention of the inspector's supervisor.
o If the terms of the order are being violated, an official sample should be obtained and the
regional office should be contacted to determine whether a Stop Sale, Use or Removal
Order should be served. Obtain a copy of the production record to document production
date(s) and document any shipments that may be in violation.
o Determine whether the products are being held for disposal. If held for disposal, inventory
the lot and determine what disposal steps have been taken.
Marketplace Inspections
If cancelled or suspended pesticides are discovered during marketplace inspections, the inspec-
tor should take the following actions:
o Contact his/her supervisor immediately. The supervisor will determine whether a Stop
Sale, Use or Removal Order should be issued.
o Determine if and when the establishment was notified of the Administrator's order.
Pesticides Inspection Manual 6-2 January 1989
-------
Chapter Six Cancellation and Suspension
o Document the receipt of the shipment by the establishment.
o Document the further sale or distribution by the establishment.
o If the product was shipped in violation of a cancellation/suspension order, the inspector
should visit the producer to determine whether other consignees may be involved.
Use Inspections
If cancelled or suspended pesticides are discovered during use inspections, the inspector should
contact his/her supervisor.
Storage and Disposal of Suspended or Cancelled Pesticides
The 1988 Amendments expand EPA's 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 authorize EPA to establish labeling requirements for transportation, storage,
and disposal of the pesticide and its container. The new law also enables EPA, for the first time, to
take direct enforcement action against violations of storage, disposal, and transportation
requirements.
The 1988 Amendments eliminate from FIFRA the requirement that EPA, upon request, must
accept suspended and cancelled pesticides and dispose of them at government expense. Under the
new law, EPA may require registrants and distributors to recall suspended and cancelled 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 cancelled 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 for storage and disposal of the pesticide that meets EPA's esta-
blished criteria. Registrants will be reimbursed for portions of their storage costs that are attri-
butable to delays in approval of storage plans.
Indemnity Payments
Prior to the 1988 Amendments, if EPA suspended and cancelled the registration of a pesticide,
the Agency was required under FIFRA to indemnify holders of the pesticide for losses suffered, up to
the cost of the pesticide. Moreover, FIFRA was silent as to the source of funding for any indemnifica-
tion (or disposal) payments that might occur. Persons previously covered by indemnification included
"end users" (such as farmers and commercial pesticide applicators) as well as pesticide formulators,
pesticide dealers and distributors, and registrants.
The 1988 Amendments end automatic entitlement to indemnity payments for all persons other
than certain end users, and provide that all indemnity payments made will come from the Judgment
Fund of the Treasury, not from EPA's operating budget. End users, such as farmers, 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
Pesticides Inspection Manual 6-3 January 1989
-------
Chapter Six Cancellation and Suspension
product whose registration is suspended and cancelled, unless at the time of purchase the seller told
the buyer in writing that the seller would not make such refunds.
The Agency has assigned a top priority status to the development of interim policies for sus-
pended and cancelled pesticides.
Pesticides Inspection Manual 6-4 January 1989
-------
Establishment Registration
-------
Chapter Seven
ESTABLISHMENT REGISTRATION
[Text to Follow in Future Draft]
Pesticides Inspection Manual 7-i January 1989
-------
Chapter Seven Establishment Registration
Pesticides Inspection Manual 7-ii January 1989
-------
Books and Records
Inspections
-------
Chapter Eight
BOOKS AND RECORDS INSPECTIONS
Page No.
AUTHORITY 1
OBJECTIVES 1
POLICY 1
PROCEDURES 2
Inspector's Obligations 2
Conducting the Inspection 2
Routine Inspections 2
For-Cause Inspections 2
Refusal to Allow Inspection 2
Confidentiality of Records 3
RECORDS REQUIRED 3
Production, Receipt, and Other Records 3
CHILD-RESISTANT PACKAGING 4
Policy and Objective 4
Records Requirements 4
Pesticides Inspection Manual 8-i January 1989
-------
Chapter Eight Books and Records Inspections
Pesticides Inspection Manual 8-ii January 1989
-------
Chapter Eight
BOOKS AND RECORDS INSPECTIONS
AUTHORITY
Section 8 of FIFRA recites the Administrator's authority to prescribe regulations requiring
producers, registrants, and applicants for registration to keep records of pesticidal operations and of
the production of pesticides and devices. Section 8 specifically excludes financial and sales data
except for shipping, pricing, personnel, and research data from records to be inspected. Section 8(b),
as amended, now requires the producers, registrants, applicants for registration, distributors, carriers,
dealers, or any other person who sells, offers for sale, delivers, or offers for delivery any pesticide or
device covered by FIFRA to make these documents available to the inspector for copying. The
inspector should be familiar with the types of records that FIFRA Section 7 requires be kept for
establishments. (See 40 CFR 169.2 for the precise regulations.)
OBJECTIVES
FIFRA regulations regarding books and records inspections were promulgated for several
reasons:
o To increase the completeness and effectiveness of EPA recalls of suspended or cancelled
pesticides;
o To enable the agency to identify areas of potential future harm to man and the environ-
ment for purposes of possible suspension, cancellation, or enforcement action;
o To identify and locate violative batches and shipments of pesticides;
o To determine whether books and records are being maintained as required by the Act and
regulations; and
o To determine the amounts of pesticides produced and distributed nationwide.
POLICY
It will be the policy of the Agency to inspect books and records whenever necessary to accom-
plish the above objectives. Inspection of books and records for the purpose of determining com-
pliance with the record keeping requirements will be limited to a routine inspection sufficient to
determine whether the firm is (1) keeping the required records, (2) in an up to date manner, and (3)
for the required time periods. For-cause inspection of records will be conducted when necessary to
(1) substantiate a suspected violation, (2) back up an enforcement action such as stop sale, seizure, or
Pesticides Inspection Manual 8-1 January 1989
-------
Chapter Eight Books and Records Inspections
recall action, (3) answer a specific request for information relevant to an Agency suspension or
cancellation proceeding, and (4) to identify possible areas of harm to man and the environment.
PROCEDURES
Inspector's Obligations
When conducting an examination of any producer's books and records, the inspector shall
proceed as follows:
o Present your official credentials.
o Present to the owner, agent or person in charge a Notice of Inspection, EPA Form 3540-2,
specifying the reason for the inspection and any violations suspected. When combining the
inspection of books and records with inspection and sampling of pesticides, only one
Notice of Inspection is required. For CRP records inspection, until EPA Form 3540-2 is
amended, include a statement on the front of the form: "Inspection of CRP records pur-
suant to Section 25(c)(3) of FIFRA and 40 CFR Part 157.36." If the registrant's books and
records are maintained in a location other than the producer establishment, it may be
necessary to issue a separate Notice of Inspection for each location.
o Obtain prior approval of the Regional Administrator or his/her designee before under-
taking inspection of certain sensitive records, including complete formula of products not
registered (169.2(a)), records of specifications or directions of a foreign purchaser
(169.2(h)), records of tests conducted on humans (169.2(j)), and records containing re-
search data relating to registered pesticides (169.2(k)). However, if the owner, operator,
or agent in charge volunteers these records for inspection, the Regional Administrator's
prior approval would not be required.
Conducting the Inspection
Routine Inspections
The inspector should determine whether the firm is keeping the necessary books and records
and for the time periods required. Any deficiencies should be documented or noted (i.e., record is
maintained at another location, failure to maintain record, or incomplete record).
For-Cause Inspections
If a firm's records are to be inspected for a reason, this reason and the types of records to be
inspected should be indicated on the Notice of Inspection. When the producer is under a Recall,
Seizure or Stop Sale Action, inventory, batch, invoice, and shipping records should be inspected to
determine the amounts and locations of the material involved.
Refusal to Allow Inspection
If the firm does not allow the inspection of any books and records, the matter should be
reported immediately to the inspector's supervisor. No attempt to force an inspection is appropriate.
Pesticides Inspection Manual 8-2 January 1989
-------
Chapter Eight Books and Records Inspections
Confidentiality of Records
Any record that is subject to inspection, and which may be considered confidential, shall be
treated in accordance with the provisions of Section 10 of the Act.
RECORDS REQUIRED
The following summarizes the records that establishments are required to maintain in accor-
dance with the regulations. (See 40 CFR Part 169.2 for a complete description of the records and the
length of time each record is required to be maintained.)
Production, Receipt, and Other Records
o Records of production of pesticides, devices, or active ingredients used in producing
pesticides:
Brand name
EPA Registration number, or EUP (Experimental-Use Permit) number
Date produced
Amount produced
Any batch code used by the producer
o Records of receipt by the producer or distributor of all pesticides, devices, and active
ingredients used in producing pesticides:
Brand name of pesticide, device, or common or chemical name of pesticide, device, or
pesticide active ingredient
Name and address of the shipper
Name of delivering and/or originating carrier
Date shipped or delivered for shipment
date received
Quantities received
o Other records that may be maintained by either pesticides producers, distributors, regis-
trants of pesticides, test facilities, or exporters:
Inventory records
Copies of all domestic advertising of the restricted use of any pesticide registered for
restricted use
Copies of all guarantees given pursuant to Section 12(a)(2)(C) of the Act
For pesticides and devices intended solely for export:
(a) Copies of specifications or directions of the foreign purchaser
(b) Copies of labels or labeling required to comply
Records of disposal
Records of any test conducted on humans
Records containing research data
Pesticides Inspection Manual 8-3 January 1989
-------
Chapter Eight Books and Records Inspections
CHILD-RESISTANT PACKAGING
Policy and Objective
Section 25(c)(3) "authorizes the Administrator to establish standards...with respect to the
package, container or wrapper in which the pesticide or device is enclosed for use or consumption, in
order to protection children and adults from serious injury or illness resulting from accidental inges-
tion or contact with the pesticides or devices regulated by this Act...." 40 CFR Part 157.36 of the
regulations requires the registrant to maintain records and, upon request by the Agency, must make
those records available to Agency representatives for inspection and copying or must submit them to
the Agency.
The objective of this inspection, therefore, is to determine compliance with other agency
requirements, specifically child-resistant packaging (CRP) requirements.
Records Requirements
The following summarizes the records that registrants are required to maintain for child-
resistant packaging in accordance with 40 CFR Part 157.36 of the regulations.
o Description of the package:
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
o Copy of the certification statement required by Section 157.34.
o One of the following types of records verifying that each package for the product is child
resistant:
Test data on the package are based on the Consumer Product Safety Commission
protocol contained in 16 CFR Section 1700.2
Test data not conforming to the protocol in 16 CFR Section 1700.20, or a set of the
measurements on the package, together with an explanation as to why the data demon-
strate that the package is child resistant
Test data, whether or not confirming to the protocol in 16 CFR Section 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 Section 1700.20. Written evidence may be one of
the following:
(a) a letter or literature from the packaging supplier;
(b) a letter from the facility that conducted the testing; or
(c) a 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:
(a) information of the kinds described in Section 157.36(c)(l) through (4) showing
that the closure is child resistant; and
(b) a written explanation of why the container is child resistant; and
Pesticides Inspection Manual 8-4 January 1989
-------
Chapter Eight Books and Records Inspections
(c) 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 Section 157.36(c)(l) through (5).
o Records verifying that the package meets the compatibility and durability standards of
Section 157.32(b) and (c).
Pesticides Inspection Manual 8-5 January 1989
-------
Chapter Eight Books and Records Inspections
Pesticides Inspection Manual 8-6 January 1989
-------
Producer and Marketplace
Establishment Inspections
-------
Chapter Nine
PRODUCER AND MARKETPLACE ESTABLISHMENT
INSPECTIONS
Page No.
AUTHORITY 1
POLICY 1
PRODUCER ESTABLISHMENT INSPECTIONS 1
Objectives 1
Inspector's Obligations and Procedures 2
Discussion with Management 2
Conducting the Inspection 2
Scope of the Inspection 2
Sampling 3
Records 3
Close-out Discussion with Management 3
MARKETPLACE INSPECTIONS 4
Objectives 4
Inspector's Obligations and Procedures 4
When To Conduct Marketplace Inspections 5
Places to Inspect 5
BULK REPACKAGER INSPECTIONS 5
Objectives 5
Bulk Facilities Inspections 6
Inspector's Obligations and Procedures 6
PREPARING THE INSPECTION REPORTS 6
Establishment Inspection Report 6
Marketplace Inspection Report 6
Exhibit 9-1: Investigation Summary 7
Exhibit 9-2: FTTS Samples 8
Exhibit 9-3: FTTS Inspections 9
Exhibit 9-4: Establishment Inspection Narrative Report 10
Exhibit 9-5: Conducting the Labeling Review 12
Pesticides Inspection Manual
-------
Chapter Nine Producer and Marketplace Establishment Inspections
Pesticides Inspection Manual 9-n January 1989
-------
Chapter Nine
PRODUCER AND MARKETPLACE ESTABLISHMENT
INSPECTIONS
AUTHORITY
Section 9(a) of FIFRA, as amended (7 U.S.C. 136g) provides the basic authority for
establishment inspections. It 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 inspect-
ing 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) makes it
unlawful to refuse to allow any entry, inspection, copying of records, or sampling authorized by
Sections 8 and 9 of FIFRA.
POLICY
It is Agency policy that the main thrust of the establishment inspection program will be at the
producer level, with a secondary supporting inspection program at the marketplace level. All
inspections should be conducted at reasonable times, which is defined as normal working hours when
the company ordinarily is open for business.
Because Section 9(a) does not provide mandatory access to manufacturing areas (including
areas where technical material is stored and areas where manufacturing, formulating, or repackaging
is done), it is EPA policy not to conduct inspections in these areas.
PRODUCER ESTABLISHMENT INSPECTIONS
Objectives
Under the 1988 Amendments to Section 19, the Administrator is to promulgate requirements
for additional data on methods for safe storage and disposal of excess quantities of pesticides and
recalled or suspended pesticides to be sent to EPA in support of the pesticide's registration. Section 9
inspection authority had been expanded to any place where suspended or cancelled pesticides are
being held to determine compliance with Section 19.
FIFRA regulations regarding establishment inspections were promulgated for the following
reasons:
o To ensure industry compliance with product registration, formulation, packaging, and
labeling requirements before the products are distributed to the channels of trade;
Pesticides Inspection Manual 9-1 January 1989
-------
Chapter Nine Producer and Marketplace Establishment Inspections
o To collect and develop evidence to support legal actions when violations are found;
o To determine whether the books and records required pursuant to Section 8(a) and the
regulations are being maintained; and
o To determine whether procedures for the disposal and storage of pesticides, pesticide
containers, and pesticide-related wastes are being followed.
Inspector's Obligations and Procedures
Upon arrival at the establishment, the inspector should (1) introduce himself or herself to the
owner, operator, or agent in charge of the facility in a professional manner, (2) present his/her
credentials, (3) issue the owner, operator, or agent in charge a completed Notice of Inspection (EPA
Form 3540-2), and (4) state the reason for the inspection and any suspected violations. Explain the
purpose of the inspection and the statutory authority for such inspections.
Discussion with Management
The inspector should obtain the necessary relevant information to complete the Establishment
Inspection Narrative Report. This information includes, but is not limited to, the following:
o EPA Establishment Number
o The name, address, and telephone numbers of the firm
o Names and titles of principal officers, partners, or owners
o Related firms
o Persons interviewed (name, title, phone number, and responsibility)
o Guarantees and labeling agreements
o Imports and Exports
o Manufacturing/batch codes
o Number of pesticides registered and number of pesticides produced
o Consignees for pesticides produced but not available for sampling
Conducting the Inspection
Scope of the Inspection
The inspection and sampling at any producer establishment should be completed in a timely
manner and is limited to (1) any pesticides or devices packaged, labeled, and released for shipment
and/or sale and samples of any containers or labeling for such pesticides or devices; and (2) all
records required pursuant to Section 8 of the Act.
Pesticides Inspection Manual 9-2 January 1989
-------
Chapter Nine Producer and Marketplace Establishment Inspections
If parts of the premises to be inspected are used for living quarters, the inspection thereof may
be conducted only if the owner or operator is fully agreeable. However, if the owner or operator
objects, a warrant must be obtained to inspect. (See Chapter 17, Warrants.) If the business operation
is physically separated from the living quarters, a warrant is not required.
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 should request that
the material to be photographed be moved to a nonsensitive area of the establishment (such as the
loading dock).
Sampling
Prior to sampling, determine whether the owner or operator in charge wants duplicate samples.
A stock survey of all the products released for shipment should be made. Label reviews should be
conducted as described in Exhibit 9-5 and official samples may be collected from pesticides that are
packaged, labeled, and released for shipment. Prepare duplicate samples in the same manner as
official samples (see Chapter 11). Upon request, restore the pesticide stocks to an orderly condition
after inspection and sampling.
Records
It is expected that the records inspection program will be made an integral part of the producer
inspection program. Records should, therefore, be examined whenever a producer establishment
inspection is made. The scope of such an investigation will vary according to circumstances. For the
most part, it may be confined to determining whether the required records are being maintained in an
up-to-date manner and for the time periods required by the regulations. In-depth inspections of
certain records should be undertaken only when the inspector has a reasonable suspicion that there
has been a violation, OK when the inspector has evidence of a violation and is trying to determine the
magnitude of the violation.
Refer to Chapter 8 for more detailed instructions on books and records inspections.
Close-out Discussion with Management
The inspector should give the owner, operator, or agent in charge of the establishment a copy of
the completed and signed Receipt for Samples (EPA Form 3540-3) for any samples taken. The owner,
operator, or agent in charge should also be notified that the results of analyses will be furnished, if
and when analyses are made.
The results of the inspection should be discussed with management. Any discrepancies noted
during the inspection should be brought to the attention of the management so that immediate correc-
tive action may be taken. The inspector should explain that violations may be found by the laborator-
ies and/or regional office.
Be sure to note in the Inspection Report any voluntary corrective actions that have already been
undertaken.
Pesticides Inspection Manual 9-3 January 1989
-------
Chapter Nine Producer and Marketplace Establishment Inspections
MARKETPLACE INSPECTIONS
Objectives
Marketplace inspections are to be conducted with the following objectives in mind:
o To detect and obtain samples of any unregistered or misbranded pesticides being
marketed;
o To determine whether restricted-use pesticides are being sold in accordance with the Act;
o To review advertising material, accompanying literature, and other labeling to determine
whether any false or misleading claims are being made for the product;
o To obtain samples of those products that were unavailable for sampling at the producer's
establishment;
o To follow-up on recalls, stop sales, suspensions, and cancellations;
o To obtain samples of products subject to deterioration; and
o 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:
o Review the labels and/or labeling (see Exhibit 9-5);
o 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 station;
o If a violation is discovered, collect a sample (see Chapter 11);
o 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 12 for instructions on issuing
Stop Sale Orders.);
o If a cancelled or suspended product is encountered, this fact should be brought to the
attention of the inspector's supervisor, who would then determine the appropriate course
of action; and
o Voluntary corrective actions should be noted in the Inspection Report.
Pesticides Inspection Manual 9-4 January 1989
-------
Chapter Nine Producer and Marketplace Establishment Inspections
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
Barber and Beauty Supply Dealers
Chemical Suppliers
Chicken Hatcheries
Dairy Equipment and Supply Dealers
Medical and Dental Suppliers
Feed, Seed, and Fertilizer Dealers
Hotel and Restaurant Suppliers
Janitorial Supply Dealers
Paint Dealers
Pest Control Operators
Swimming Pool, Spa, and Waterbed Dealers
Wholesale Grocers
Lawn and Garden Supply Dealers
Additional leads to new sources of nonregistered pesticides include the following:
Dealers (question dealer regarding others in the same business)
Local newspaper advertisements
Trade journals
Yellow Pages telephone directories
Information from state officials
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.
Objectives
The primary objectives of the bulk repackager 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.
Pesticides Inspection Manual 9-5 January 1989
-------
Chapter Nine Producer and Marketplace Establishment Inspections
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. 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.
Particular items to check at a bulk site include, but may not be limited to, the following:
b Labels on all bulk tanks;
o If the firm is repackaging, verify the maintenance of a manufacturing contract between the
firm and the basic registrant;
o Conduct label review in accordance with Exhibit 9-5;
o Sample, as appropriate, in accordance with established procedures (Chapter 11);
o Review sales invoices to verify transfer is occurring in bulk quantities; and
o 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 infor-
mation to portray accurately what is taking place at the establishment with regard to pesticide produc-
tion. The format of the report may vary, but the content should include at a minimum the information
listed in the Discussion with Management. In addition, the FIFRA Investigation Summary (EPA
Form 8580-7), FTTS Sample Report, or your region's current sample collection report may be used.
Marketplace Inspection Report
The FIFRA Investigation Summary Report (Form 8580-7), the FTTS Inspection Report, or
your region's current sample collection report may be used for each inspection conducted and sample
collected. This report is acceptable for routine nonviolative inspections. Where for-cause inspections
were conducted and/or suspected, violative samples were collected, a brief narrative report in memo-
randum form should also be completed.
Pesticides Inspection Manual 9-6 January 1989
-------
Chapter Nine
Exhibit 9-1
Investigation Summary
^ak •••% Jft
•aK.E>iR|f\
\lFtI ^^
US ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, DC 20*60
FEDERAL INSECTICIDE, FUNGICIDE, AND
RODENTICIDE ACT
INVESTIGATION SUMMARY
1. INVESTIGATION IDENTIFICATION
2. Region/State
Dan
11-14-88
3. Inspecting Org.
IntpKtor Number
F3001
Dally Sequence
01
4. Facility Function
pn
6. Ruton for Invntlgatlon
FCP
nq
5. Invntlgatlon Type
PR
,-fiEl
Referral
FDA
Agency
8. Warrant Required
YetD Nod
SAMPLE INFORMATION
1 7. Sequence Numbir
ni
18. Stete Sample No.
10. Product Code
ni
21 . Projtet Codt
A-5
20. EPA Registration Number
90000-1
22. Sample Medium
PES
23. Date Collected
11-14-88
9. Facility Name (Productr/Dmltr/Uttr)
Good Earth Chemical Co.
10. Street
711 Industrial Street
11. City
San Francisco
12. State
CA
13. ZIP Code
94105
14. Establishment Number
90000-CA-01
15. DUNS Number
24. Sample Type
16. SIC Codes
25. Date Shipped
PEI
26. Lot or Other Code Number!
50 cases/12/1 Ib. cans coded "7011"
27. sample iden.tfic«ion(Aerogoi can) "Good Earth Pyrethrin Insecticide ... 16 oz. ..
Pyrethrin 1.5%, Piperonyl Butoxide 0.50%, Petroleum Distillate 98.00% ....
Good Earth Chemical Co. , San Francisco. CA 94105 ..."
28. Amount Before Sampling
0 cases/12/1 Ib. cans
^ 50 ca
29. Descrlptio
4/16 oz. aerosol cans taken, 1 each from 4 previously unopened cases.
30. Sample Preparation
Labels idfd. "11148830010101, Subs. 1/4, JRD". Cans polybagged in inverted
polybag and sealed with EPA seal idfd. "11148830010101 John R. Doe".
31 . Related Samplei
None
32. Raaton for Collection
Suspected contamination with Parathion.
OTHER FACILITIES
33. Producer
Good Earth Chemical Co.
36. Street
711 Industrial Street
40. Shipper
N/A
44. Dealer
34. Establishment Number
90000-CA-01
37. City
San Francisco
41. City
45. City
35. DUNS Number
38. State
CA
39. ZIP Code
94105
42. State
46. State
43. ZIP Code
47. ZIP Code
48. Original Records
RPA.MElC-P.En.Yar
61. Sample Delivered To
Consolidated Freic/htwa
-i.cide Lab
49. Region Copy
San Francisco. CA
64. Credential! 165. Notice of
Presented j[jj 1 Inspection
56. Receipt for
Samples
RECORDS
iBrsss
11-15-88
50. Sample Copy
SEIC Lab
S3. Bill of Lading Number
57. Sample Con
$8.00
vD eO
58. Collection Station
San Francisco
59. Remarks
Report of Analysis to: John R. Doe, manager.
60. Inspector's Name
Tehn A.
61. Inspector's Signature
EPA Form 8580-7 (343)
Replaces EPA Form 3540-7, which is obsolete.
INSPECTION FILE
Pesticides Inspection Manual
9-7
January 1989
-------
Chapter Nine
Exhibit 9-2
FTTS Samples
rrrs SAMPLES
•INSPECTION DATEi___/___/ •INSPECTOR NUMBER:
•INSPECTION SEQ: 'SAMPLE SEQt DATE SAMPLE COLLECTED! / /
LAB HAMEl
SAMPLE MEDIUM:
DATE SAMPLE SENT/DELIVERED»_/__/_
PRODUCER NAME/COLLECTION LOCATION!
VIOLATIVEt Y or M
DATE RESULTS RECDt / /
PRODUCT NAME:.
AMOUNT*
REG NOl
LOT It
SAMPLE DESCRIPTIONi
SAMPLE DELIVERED TOi
SEALED! r or N
•SAMPLE SEC:.
LAB NAME:
DATE SAMPLE COLLECTED!
SAMPLE MEDIUM!
DATE SAMPLE SENT/DELIVEREDl_/__/_
PRODUCER NAME/COLLECTION LOCATION!
VIOLATIVE t T or N
DATE RESULTS RECDt / /
PRODUCT NAMZi.
AMOUNTt
REG MOi
LOT tt
SAMPLE DESCRIPTION!
SAMPLE DELIVERED TOt
SEALED! t or N
Pesticides Inspection Manual
9-8
January 1989
-------
Chapter Nine
Exhibit 9-3
FTTS Inspections
•INSPECTION DATE I / /_
•LEGISLATION IND; T or F
•REGION/STATE:
•REASON FOR INSPECTION!
•^•^••^
DATE RPT RECD: / /
CBIt Y or N
•FACILITY rUNCTIONj
REMARKS:
•SITE NAME»_
•SITE ADDR:_
•SITE CITY:
•SITE STATE:_
SITE DUNS:
SITE SIC CODESi
•PARENT CO NAME:_
•PARENT CO ADDRi"
•PARENT CO CITYi""
•PARENT CO STATET
INSPECTOR'S SIGNATURE
FTTS INSPECTIONS
•1NSPECTOH NUM:
•INSPECTION TYPE:
INSPECTOR NAMEi
REFERRAL TYPEt
WARRANT REQUIRED: Y or N
NUMBER SCHOOLS!
EPA ESTABi
•INSPECTION Sty:
•NUMBER OF SAMPLES I
TED FACILITY; Y or N
SCHOOL TYPE:
•SITE ZIP:
SITE COUNTY:
•PARENT CO ZIP:
DATE
Pesticides Inspection Manual
9-9
January 1989
-------
Date of Visit
Establishment Inspect...! Narrative Report
Estab. Registration No.
Inspector's
Signature
Person(s) Interviewed:
Title
Title
_Phone
Phone
Establishment Name & Address:
Related Firms:
Names & Titles of Principal Officers
Phone Number
Does the Firm Perform QA/QC Tests on Products?
Are Retain Samples Kept Per Batch? yes
:es
e
no Held
r yes no
Time
Are Batch Codes Used? yes no If yes, explain code
Does the Firm Private Label for Others?_
Are Manufacturing Agreements in Place?
yes
no
yes
no
Did Inspector Look At Manufacturing Agreement? yes
Is Another Firm Private Labeling for This Firm? yes_
If yes, Who
no
no
Does Firm Distribute Products Produced Elsewhere? yes_
Does Firm Maintain Complaint File? yes no
Are Complaints Reported to US EPA? yes no
Is Legal Counsel Retained? yes no
Are Guarantees Given and Received? yes no
no
Are Production Records Maintained? yes no Including:
Product Name yes no EPA Reg. No. yes no
Batch Code yes no Amount Per Batch yes no
yes no
yes no
Are Shipping Records Maintained?_
Do Shipping Records Include: Brand Name_
Quantity yes no Name & Address of Consig. yes no
Date Shipped yes no Name of Orig. Carrier yes no
Does Firm Export Any Production? yes no If yes, is
Firm in Compliance with Export Regulations? yes no
Does Firm Import Pesticides? yes no If yes, are
These Products in Compliance with FIFRA?_ yes no
Are Disposal Records Maintained? yes no
Identify Types and Amounts of Wastes or Containers Held
for Disposal and Type of Disposal Practice Used:
o
BT
fii
•e
D
O
B
v>
a?
B
o
a
o
VI
•O
O
fl
5'
o
2
O
o
•o
o
cr
r+
\C
-------
EPA Reg. No. of
Pesticides Registered
xxxxxxxxxxxxxxxxxxxxxx
1)
2)
3)
4)
5)
6)
7)
8)
9)
10)
11)
12)
13)
14)
15)
16)
17)
18)
19)
Prod
V
N
VL&
RFS
V
N
Establishment Inspection Na.ratlve Report - Page 2 Inspector's
Sample
No.
XXXXXXXXX
j
D/P
XX)
CRP
\
I
LR
\
I
Initials
This section 1s to be filled in only when the products
. are not available for sampling at the producer
Consignee
XXXXXXXXXXXXXXXXXXX
Address
xxxxxxxxxxxxxxxxxxmxxxxx
Date
1 Ship.
XXXXXX
Invoice No.
XXxxXxXXxXX
fit
n
Z
5*
o
ff
BT
cr
-------
Chapter Nine Exhibit 9-5
Conducting the Labeling Review
Producer Establishment Inspections
When a producer establishment inspection is being conducted, a word-for-word com-
parison 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 extend label comparisons to "bin" labels at the discretion of his/her super-
visor. Official samples may only be collected from products that are packaged,
labeled, and released for shipment. However, a "bin" labeling review can provide a valu-
able background for follow-up sampling at consignees and obtaining voluntary corrective action
at the producer level.
Marketplace Inspections
When conducting label reviews, the inspector must 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. Brandr 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 Registra-
tion No. XXXX-XX," "EPA Reg. No. XXXX-XX," or "EPA Reg. No. XXXX-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 substate-
ment giving the percentage of total and water-soluble arsenic, each calculated as elemental
arsenic.
Pesticides Inspection Manual 9-12 January 1989
-------
Chapter Nine Exhibit 9-5
Warning or Caution 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 the label: (1) a skull and crossbones, (2) the word "POISON" in red on a contrasting back-
ground, and (3) a statement of practical treatment. In addition, the label must contain precau-
tionary 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 lan-
guages 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:
o 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."
o 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 instruc-
tions."
Statement of Use Classification. All RUP products must have the RUP statement on the top
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 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 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 dis-
covered, he/she should call his/her supervisor while still in the vicinity of the establishment.
The supervisor may have access to information on the product that would help to decide whether
to have the product sampled or even stop sale the product.
Pesticides Inspection Manual 9-13 January 1989
-------
Chapter Nine Exhibit 9-5
Accompanying Labeling
Copies of accompanying labeling initiated and dated by a responsible company representa-
tive should be collected and documented.
When violative labeling is collected, it should be documented with an affidavit signed by a
responsible individual of the firm, which clearly states the relationship of the labeling to the
goods, including the following:
o 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.
o Location of Labeling. Report the location of each piece of literature and how much of
each is on hand.
o Methods of Distribution. Determine how the labeling is distributed (i.e., accompanied
product, shipped under separate cover).
o 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 text.
o Instructions to Dealer. The manufacturer or shipper sometimes provides sales promo-
tion instructions to the dealer. Obtain copies of such instructions, if available, as well as
any verbal instructions on how to use them.
Pesticides Inspection Manual 9-14 January 1989
-------
Interagency Pesticide
Referrals
-------
Chapter Ten
INTERAGENCY PESTICIDE REFERRALS
Page No.
AUTHORITY 1
OBJECTIVE 1
POLICY 1
PROCEDURES 1
Referrals from EPA to FDA 2
Referrals from EPA to State Agencies 2
Exhibit 11-1: MOU - FDA/EPA/USDA 3
Exhibit 11-2: Interagency Referral Form 6
Pesticides Inspection Manual 10-i January 1989
-------
Chapter Ten Interagency Pesticide Referrals
Pesticides Inspection Manual 10-ii January 1989
-------
Chapter Ten
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 the Environmental Protection Agency (EPA) and the Food and Drug
Administration (FDA).
POLICY
The Memorandum of Understanding between FDA and EPA on Regulatory Activities
Concerning Residues of Drugs, Pesticides, and Environmental Contamination in Foods (signed
December 7, 1984; 50 FR 2304; Exhibit 11-1) 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.
PROCEDURES
To improve the quality of referrals from FDA to EPA, FDA field staff must refer cases of
suspected pesticide misuse to EPA only when all of the following conditions are met:
o FDA has evidence clearly demonstrating that the pesticide was used on the food or feed in
a manner contrary to its EPA-approved use and labeling.
o FDA laboratory results (original and check analysis) show residues of a pesticide for which
FDA regulatory action would be initiated against the food or feed because:
The tolerance for the pesticide is exceeded; or
Pesticides Inspection Manual 10-1 January 1989
-------
Chapter Ten Interagency Pesticide Referrals
No tolerance (or exemption from tolerance) has been established and the level of
residue appears to be due to purposeful use as opposed to environmental or some
other unavoidable source of contamination.
o The misuse occurred while the food or feed 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.)
o The person or firm that misused the pesticide is known or suspected.
FDA will also inform EPA of any other state or local agencies that have been notified.
Referrals from EPA to FDA
The nature and location of EPA inspections make it unlikely that many referrals of potentially
illegal residues will be made from EPA to FDA. However, when EPA discovers situations that might
result in illegal residues, they should be referred to the FDA district office so that the crop or 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. Other
examples may include EUP's and Section 18 emergency exemptions.
Referrals from EPA to State Agencies
The EPA response to an FDA illegal residue referral will normally be to refer it to the
appropriate State lead pesticide agency for follow-up. Referrals will be tracked and reported to FDA
in accordance with procedures established by the Regions. A suggested format is attached as Exhibit
11-2.
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 should be notified immediately by telephone with all information that is readily
available so that the hazardous situation can be corrected promptly.
Pesticides Inspection Manual 10-2 January 1989
-------
Chapter Ten
Exhibit 10-1
MOU - FDA/EPA/USDA
FadaraJ
/ VoL SO. No. tl
January IB. 1W
DEPARTMENT OF AfifMCULTUfle
Food Safety and Inspection Servtoa
Agricultural Marketing !
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Adirunritrarlon
ENVIRONMENTAL PROTECTION
AGENCY
end environmental ramlJiaiMTily mat
may adatorate food.
Thia memorandum of understanding
(MOU) supersedes an April 1075 MOU
between t*» AadoMi aad Plant Health
Inspection Service (APHIS) and FDA. an
Aagaat H7TMOU between ft» faed
Safety and QulBy Service (PSQSf and
EPA. and • May 1W5 MOO batween
FDA and EPA. By a reorganization
dated Januarys, HO*. Is* meal ana*
poultry inspection prognai was
transferred horn APHIS TO FSQSi aad
by a reorgutuBaB dated September XX
1981, it wa* transferred t» fS&
This MOD doe* aotnodSy any
existing agraameat* between OGDA
•FDA. and/or EPA. It supplements a*
MOU, reviMd la 1M3. defining A*
authentic* aad respensAffitfes efFTM
and AMS fegardmg eggraied egg<
producti.
//. Bocxgrovrtv
Food iadadtag meat poultry, egg.
product*, i
Residue* ot Drug*, P»«OcW««, and
Environmental CcTrtBmlhsnts hi Food*
Manoraadum of Uadarstanding
Among the
Food Safety and Inspection Senaee aad
Agricultural Marketing. Service- US.
Department al Agriauftura
and the
' Food and Drag Admnttsfranan UA
Department, at Heal A aad Human.
Services
And the
U.S. Environmental Protection Agsncj
I. Papon
October S. IBM.
Tim purpose of thh agreement fi to set
forth the working relaUonsnips among
tov U.3, Department or Agricunim
(USDA). tpecfflcafly the Food Safety
and luapetfluB Servtee (PSB) and the
Agrh.utrui al Mm ietfag Servtee (AMS);
the Food and Drug Administratta*
(FDA), and the Environmental
Protection Agency (EM} to
more effective, efficient,
coordinated Federal lugalaluij
concerning residues of dregs, peitiddes,
adukera*Et} wW> residues of drags,
pesticides, or envfronmentef
contaminaixnT ac a resun of QTQSJ or
pesffcide misuse [ta.. unapprovadoi
non-cegiatoeil aaej or bacauaa of tha
preaaac* of pesticide* or etfceit
rhasiirili in tha eavvoaawnt or otker
indirect aimim of contaoniBften'.
Ragardfcssi ol the source of tho
aeMteratioa the inunedrate and prmnry
concern fs to assure rcmorai of
adulterated food from consumer
channels and to prerenr rorfher
marketing of such adulterated food.
USDA is charged with the
enforcement of the PMerai Meal
Inspection Act (FMtA)l &e Peutoy
Products Inspection Ad (VflA); aaditka
Egg Products Inspection Act (EPIA).
Within USDA. FSB Is responsible for
the wholesotneness and safety of meat.
poultry, and products thereof intended1
for human consumption. Tm'jii
accomplished, in part by inspection at
slaughtering and processing
estaonsnmcntS' asd by, sampunfli &n bt
adulterated under the FMIA or PP1A.
nfnS • ^BVpODSvb W WOf iBiT
whofe*oneae*» and safety o* agg-
products. Aaung otter mmga. It
conduct* InspectJon and sample* for
suck leshlues at plants processing
product* to asmre copipHaiice with
ERA.
FDA is charged with the enforcement
of the Federal Food. Drug, and Cosmetic
Act (FPDCA). Under this act. FDA ts
responsible for ensuring that human
Inndi sad ssanul fsrrts urn safn nnrt '
among other things, do not contain
uJBoaliasfdue* of drags, pesticides, or
enviromnentaf eontaminents. PDA also
approves* ULUUS) ased for foou producing
anunal*. estBoUsfce* toBerances for
residues of animal drugs in edible
tissues, establishes, tolerances (other
than for pesticides) aad action level* for
unavoidable environmental
contanrinsmat that BWT adadterate food.
inspects the processing and distribution
examines samples of these products to
assure conpBaace with the FPDCA.
EPA is responsible for administering
and enforcing the Federal Insecticide.
Fungicide, aad Bodeahcide Act [FIFRAJ.
Under this act EPA has the authority to
protect humans and their environment
from unieasanabte adverse effect* of
pesticide chemicals by regatatmg the
sate and asv of pesticide products. EPA
samples piiiBtMij chaim'uils to verify
labal daoas concerning content and
safely, aas)&r«*stiga4es incidents where
the misuse rf pesfJcides may hare
occurred. EPA is> responsible under *e
FFDCA tor. estabttsmng tolerances and
recommeaamg actioa> levels to FS1S and
FDA for residue* of pesticides in food
and has the aamority to monitor the
effectiveness of surveillance and
enforcement. Under tba. Toxic
Substances Control Act (TSCA). EPA
also regulates, otter rtianyV.^
substance* (e^ {hduafrbl chemicals)
that can adulterate food.
Because FSIS, AMS, FDA. and EPA
have common, and related objectives In
carrying ont their respective
^linimillpllf Fi^p^iylfrffifrfpf it 13
desirable andta die public Interest to
set forth hi a memorandum of
understanding me working
arrangements adopted to oucnarge
these respoasfbOities as effectively as
possible.
///. SukHtmrr of Agreement
A. USDA agrees to;
1. Pumlsh EPA and FDA headquarter
with a Bst of aH fechnUy inspected1
meat and poultry slaughtering and
processing establishments and egg
product pt«nff Tlite ahafl include
periodic opdates of changes or additions
to the list
2. Upon request sample and analyze
specific lots of IVestock and poultry at
slaughtering establishments and egg
projects at pi messing plants mat PDA
or EPA suspects contain residues of
drug* pesticides, erevtronmental
Pesticides Inspection Manual
10-3
January 1989
-------
Chapter Ten
Exhibit 10-1
FodaoJ RegUter / VoL 50. No. 11 / Wettoe«dgy, January 16. 1965 / Notices
2305
contaminants thai exceed tolerances or
action level* or otherwise adulterate
meat or poultry, or producti thereof, or
egg producti.
3. Notify the appropriate EPA regional
office and headquarters of any findings
of residues of pesticides or chemical
substances in edible tissues samples of
meat or poultry, or products thereof, or
egg products that may indicate a
violation of FDFRA or TSCA. Subsequent
relevant information on these findings
shall be similarly provided.
4. Notify the appropriate FDA district
office and headquarters of any findings
of residues of drugs, pesticides, or
environmental contaminants in edible
tissue samples of meat or poultry, or
products thereof, or egg products that
exceed tolerances or action levels or
otherwise adulterate such food.
Subsequent relevant information of
these findings shall be similarly
provided.
5. Review and investigate as
necessary reports from FDA or EPA that
meat or poultry, or products thereof, or
egg products may be adulterated with
residues of drugs, pesticides, or
environmental contaminants and notify
the referring office of the results.
6. Keep FDA and EPA headquarters
informed of all FSIS and AMS sampling
and testing programs for residues of
drugs, pesticides, and environmental
contaminant* in meat or poultry, or
products thereof, or egg products; and
consult periodically with FDA and EPA
headquarters on FSIS's National
Residue Program through the agencies'
Surveillance Advisory Team and other
appropriate means.
7. Provide FDA and EPA headquarters
with periodic reports listing results of all
such residue sampling and testing
programs, including, to the extent
appropriate, the number and product
identity of samples tested, the residues
for which tests were conducted, the
analytical and statistical methodologies
used, and other related information.
8. Notify FDA headquarters whenever
FSIS plans to seek an action level or
tolerance from EPA for a peoticide
residue ir. meat or poultry so that FDA
may also consider the need for an action
level or tolerance for that pesticide
residue in animal feed and Einimal feed
ingredients.
9. Provide FDA with any other
information obtained concerning
residues of drugs, pesticide*, or
environmental contaminant* that may
indicate a violation of the F1PDCA; and
provide EPA with any such infonkattoa
that may indicate • violation of FTPRA
or TSCA.
B. FDA agrees to:
1. Notify the appropriate BPA regional
office of investigations or findings
concerning possible misuse of pesticides
or chemical substance* that may
indicate a violation of FffRA or TSCA.
Subsequent reterant information on
these investigations or findings shall be
similarly provided.
2. Notify USDA headquarters of
findings of illegal residue* of drags.
pesticides, or environmental
contaminants in human food or *«tmal
feed which indicate that the residues
also may be present in meat or poultry,
or producti thereof, or egg pnxntcts.
Subsequent relevant information on
these findings shall be simiUriy
provided.
3. Notify the affected FSIS regional
office or headquarters, as appropriate,
upon obtaining any information that
animals that have been or are expected
to be offered at any establishment under
FSIS Inspection may contain residues
that would adulterate meat or poultry,
or products thereof. Subsequent relevant
information on these findings shall be
similarly provided.
4. Review and investigate as
necessary reports from USDA or EPA
that animals or eggs intended for human
food or animal feed may contain
residues that would adulterate such
food or feed and notify the referring
office of the results.
S. Keep USDA headquarters informed
of all FDA sampling and testing
programs for residues of drugs,
pesticides, and environmental
contaminants In animal feed, dairy
products, and eggs and provide USDA
headquarters with periodic reports
listing results, including, to the extent
appropriate, the number and product
identity of samples tested, the residues
for which tests were conducted, the
analytical methodology used, and other
related information.
8. Keep EPA headquarters informed of
all FDA sampling and testing programs
for residues of pesticides and chemical
substances and notify EPA of any
significant new findings from these
programs.
7. When requested by USDA. consider
the need for establishing tolerances or
action levels for environmental
contaminants m meat, poultry, or eggs.
8. Notify USDA headquarters
whenever it intend*, to rstahtoh or
amend a Mtennce for an nniao.1 drug or
a tolerance «racttoB tarsi far on
environmental coQt*JHfnflot ttat noy
affect USDA's responstbOfUe* aider the
FMIA. PPIA, or KP1A, wdtadude •
summary of fbe Informalfon and *
evaluation noon wfcfoli moo Menace or
action tevel fc ttood tad a Method of
analysis to be used to enforce t*eh
tolerance or action level Also notify
USDA headquarters whenever it intends
to seek an action level recommendation
or tolerance from EPA for a pesticide
residue in animal feed, feed ingredients.
dairy products, or eggs.
9. Provide USDA with any other
information obtained concerning
residues of drugs, pesticides, or
environmental contaminants that may
indicate a violation of the FMIA. PPIA.
or EPIA; and provide EPA with any such
information that may indicate a
violation of FDPRA or TSCA.
10. Notify FSIS headquarters when it
authorizes to be used for food animals
that have been treated with an
investigational new animal drug under
section 512(j) of the FFDCA and provide
relevant information upon which FSIS
can authorize slaughter.
C. EPA agrees to:
1. Notify the appropriate FDA district
office and USDA headquarters, as
appropriate, of any pesticide use
encountered by EPA that may have
resulted in residues that adulterate
human food or animal feed, and include
relevant safety information on the
pesticide(s) involved. Subsequent
relevant information shall be similarly
provided.
2. Review and investigate as
necessary, or refer to the appropriate
state enforcement authority for
investigation, reports from USDA or
FDA of pesticide misuse or other
possible violations of FIFRA or TSCA
and notify the referring office of the
results.
3. Provide USDA and FDA
headquarters with information from any
monitoring programs, investigations, or
other sources involving pesticides or
chemical substances that may
contaminate human food or animal feed.
4. Notify USDA and FDA
headquarters, as appropriate, or
regulatory actions under TSCA
involving the manufacture, processing.
distribution in commerce, use. or
disposal of chemical substances when
the risks being assessed may include
contamination of human food or animal
feed.
5. Notify USDA headquarters and
FDA headquarters and regional offices.
as appropriate, of experimental use
permits issued under section 5 and
emergency exemptions granted under
section 16 of PIPRA that involve uses of
pesticide* that might affect food: and
provide relevant Information on the
approved non-tcgittered ase, including
regulatory Hmtta coraMished for residues
of the pesticide resorting from such use.
8. Recommend, open request from and
in consultation with FDA and/or FSIS.
Pesticides Inspection Manual
10-4
January 1989
-------
Chapter Ten
Exhibit 10-1
2SM
/ Vpt 50. Nte'H /
y. January 16. MSB / Npttow
action levels for pesticide residue* In
human food or animal hod and ooniida
the need for tolerance*.
7. Notify USDA and FDA
headquarters, at appropriate, whenever
it intendt to establish or amend a
tolerance, temporary tolerance, or
exemption from the requirement for a
tolerance for a peatidde reiidue In food.
and include a summary of the
information and evaluation upon which
the action is based and a method of
analysis to be used to enforce such
tolerance or temporary tolerance.
D. It is jointly agreed that each agency
will:
1. Maintain a close working
relationship with the others both in
headquarters and in the Geld, with FS1S
coordinating the headquarters
relationship for USDA
2. Exchange information with the
others relative to analytical
methodology it uses to Identify and
quantify residues of drugs, pesticides.
and environmental contaminants in
food, and cooperate in the development
and implementation of analytical and
statistical methodologies to ensure
comparability of results in the
examination of food and avoid
duplication of effort
3. Advise the other agency or agencies
and exchanges information whenever it
is considering proposing or Issuing
regulations regarding residue policy or
procedures that may affect the other
agency or agandes.
4. Advise the other agency or agenices
and exchange information whenever it
is considering a release of informational
materials that may affect the other
agency or agencies.
5. When exchanging information, each
agency will comply with any relevant
restrictions of Federal law concerning
trade secrets, confidential commercial
or financial information, and personnel.
medical, or other similar Information
constituting a clearly unwarranted
invasion of personal privacy.
Implementing regulating and procedures
shall apply to any agency provided with
such material* under this agreement
a Coordinate the residue
investigations with the others, and win
state and other government officials, as
appropriate, to avoid duplication of
effort
7. Upon request make agency
personnel available for testimony and
make agency documents available to
support a regulatory action Involving
residuns of drugs, pesticides, or
environmentsJ contaminants.
8. Advise the other agency or agendes
whenever engaging in litigation
Involving Issues that affect the duties of
the other agency or agencies regarding
residues of drags, pestiddes or
fnv
-------
Chapter Ten
Exhibit 10-2
Interagency Referral Form
I . REFERRAL TO
Agency:
Location:
3. DATE REFERRAL FORWARDED
Date Mailed:
Advance Telephone Notification Given:
Cl *
Q 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 I NCI DENT /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 Mall:
7. FIRM (INDIVIDUAL) AFFECTED
Name and Location of Firm or
Individual Affected by Problem:
9. REVIEWING OFFICIAL
Name/Title of Person Responsible for
Determining Response to Referral:
Phone Number:
10. FOLLOWUP DECISION
| | Immediate Followup
| | No n- Immediate Followup
| | Referred to Another Agency
Specify Agency and Contact:
| | No Followup
Reason:
Date Followup Decision Made:
11. ACTION TAKEN
Describe foilowup 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 1n Block 12.
Pesticides Inspection Manual
10-6
January 1989
-------
Pesticide Product Sampling
-------
Chapter Eleven
PESTICIDE PRODUCT SAMPLING
Page No.
AUTHORITY 1
OBJECTIVES 1
POLICY 1
SAMPLE COLLECTION 2
Sources of Pesticide Product Samples 2
Types of Samples 2
Physical Samples 2
Induced Samples 2
Documentary Samples 2
Import Samples 2
Use Dilution (Tank-mix) Samples 3
Sample Procedures 3
Small-Sized Units 3
Larger-Sized Units 4
Dry Material 4
Liquid Material 5
Labels : 5
After Sampling 5
Restoring Lot to Order 5
Preparing Duplicate Samples 5
Preparing Receipt for Samples 6
Payment for Samples 6
SAMPLE DOCUMENTATION 6
Authority 6
Objective . 6
Policy 6
Samples Collected at the Producer 6
Samples Collected in the Marketplace 7
Samples Collected from the User 7
Responsibility 7
Records Showing Shipment 7
Invoice 7
Bill of Lading 8
Freight Bill 8
Pesticides Inspection Manual 11-i January 1989
-------
Chapter Eleven Pesticide Product Sampling
Waybill 8
Mail or Parcel Service Shipments 9
Marketplace Sample 9
Induced Sample 9
Shipment by Noncommercial Vehicle 9
Dealer's Statements and Affidavits/Statements 9
Dealer's Statements 9
Affidavits/Statements 9
Dealer's Affidavit 10
Affidavit/Statement 10
Refusal to Sign 11
Investigation Summary Report 11
Memorandum to Accompany Investigation Summary Report 11
SAMPLE PREPARATION, CUSTODY, AND HANDLING 11
Identification of Samples and Labels 11
Identification of Documents 12
Records 12
Accompanying Literature, Labeling, Photographs, and Exhibits 12
Sample Custody 12
Preparing the Official Seal 12
Applying the Seal 13
Custody 13
Mode of Transfer 14
Hand Delivery 14
Common Carrier 14
U.S. Postal Service 15
Exhibit 11-1: Receipt for Samples 16
Exhibit 11-2: EPA Form 3540-13 17
Exhibit 11-3: Dealer's Statement (EPA Form 3540-19) 18
Exhibit 11-4: Dealer's Affidavit (EPA Form 3540-12) 19
Exhibit 11-5: Affidavit/Statement 20
Exhibit 11-6: Custody Record 21
Exhibit 11-7: Hazardous Materials Definition 22
Exhibit 11-8: Guide for Shippers 25
Exhibit 11-9: Hazardous Materials Shipping Papers 27
Exhibit 11-10: Sources of Hazardous Materials Markings, Warning Labels,.and Placards. 35
Exhibit 11-11: Mailability of Hazardous Materials 37
Pesticides Inspection Manual 11-ii January 1989
-------
Chapter Eleven
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 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.
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 or dealer inspection. A sample must be
suitable to support the government's charge that there has been a 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:
o A representative portion of a batch of a pesticide for laboratory analysis;
o A report of the inspector's observations of the batch, which may also include photographs
and/or copies of records, data, or correspondence;
o Labeling and/or literature, or copies of these items, that pertain to this product and/or
batch; and
o Signed statements or sworn affidavits from persons who may potentially serve as witnesses.
POLICY
Samples should be collected and prepared in accordance with the procedures outlined in this
manual. The inspector should fully document any deviations from these procedures in his/her field
notebook.
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
Pesticides Inspection Manual 11-1 January 1989
-------
Chapter Eleven Pesticide Product Sampling
an important role in minimizing this interval by promptly forwarding all samples and records to the
laboratory. Pesticide formulation samples should be held for no more than 5 working days from the
date of collection until shipping to the laboratory.
SAMPLE COLLECTION
Sources of Pesticide Product Samples
Producer Establishments. Producer establishments are the primary source of pesticide/device
samples.
Marketplace (wholesale and retail establishments). Samples of unregistered pesticides,
investigational samples, or those pesticides that are not available for sampling at the producer level
are collected at the marketplace.
Users. Samples of pesticides may also be collected at the user level in support of use, follow-
up, and experimental-use permit investigations.
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
A physical sample (identified as "PHY") is an actual sample of the pesticide formulation or
device. Copies or photographs of the labeling, advertising, and any records showing shipments of the
product are collected for documentary purposes only.
Induced Samples
Induced samples of pesticides or devices are usually requested by mail or telephone. An
induced sample should not be considered until all other sources for direct purchase have been
exhausted. Complete documentation is necessary, including the original advertisement.
Documentary Samples
A documental sample (identified at "DOC") is when a physical sample of the pesticide or device
is not collected. Copies of the labels and/or advertising, and copies of any records showing shipments
of the product and the responsible parties are normally collected for documentary purposes only.
Import Samples
Import samples (identified as "Import") 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,
Pesticides Inspection Manual 11-2 January 1989
-------
Chapter Eleven Pesticide Product Sampling
foreign invoices, and records showing movement from the port of entry, if necessary (refer to Chapter
15, "Pesticide Import and Export Program").
Use Dilution (Tank-mix) Samples
(See Chapter 14 and its appendix.)
Sample Procedures
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 (a) the product
has been produced, and (b) it is the intent of the producer that such product be introduced into
commerce.
At the producer establishment level, such intent to introduce the product into the channels of
trade may be evidenced by the following:
o The producer's assertions that the material being sampled is representative of what is
actually sold; or
o 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) establishment level, the product is considered to have
been "released for shipment" by the producer establishment and, therefore, is subject to inspection
and sampling.
Small-Sized Units
Small-sized units are defined as those units containing liquids of one gallon or less or solids
weighing 20 pounds or fewer and are typically intended for retail distribution.
Samples should be preferably 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 it is
necessary to sample more than one code or batch, all should be included under one sample collection
number. All nonsampled lot numbers should be described in the Investigation Summary Narrative
Report, to the extent possible. When only a case code is evident, each sample should 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 need be sampled and the number of cases of each size is recorded in the Investigation
Summary Narrative Report. If the labels are not identical, the inspector should sample all sizes and
submit under separate sample numbers. In addition, the inspector should record the number of cases
of each size.
Table 11-1 shows the number of retail units to be collected. However, the inspector should
consult with the laboratory if he/she is unsure or if unusual circumstances are encountered.
Pesticides Inspection Manual 11-3 January 1989
-------
Chapter Eleven Pesticide Product Sampling
Table 11-1
SAMPLE SIZES TO COLLECT FOR PESTICIDE PRODUCTS
Small-Size Units
Active ingredient more than 1% Collect enough units to total at least 8 oz.
Active ingredient less than 1% Collect enough units to total at least 16 oz.
Pressurized containers Collect at least four units
Larger Size Units (Liquids and Solids)
Active ingredient less than 10% Collect at least 4 oz. from each of two
containers*
Active ingredient more than 10% Collect at least 1 oz. from each of two
containers*
Tank mixes Collect at least two 4 oz. samples in addition to
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-sized 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
directly for commercial use.
Subsampling of larger containers is usually recommended for the following reasons:
o The cost of larger amounts is frequently prohibitive;
o Larger-size units are difficult to handle and costly to ship; and
o The increased amount of material left over after testing creates disposal problems.
Therefore, the inspector should subsample all dry products in containers in excess of 20 pounds
and liquids in containers in excess of one gallon. Special situations warrant deviations from these
guidelines, such as dry lawn care products and livestock salt blocks; in which cases, the entire retail
unit should be sampled and submitted to the laboratory.
Dry Material. A previously unused, disposable type plastic tube (available from golf equipment
suppliers)or clean grain trier (Fisher Number 14-208 or eq.) should be used for each batch or lot
sampled to avoid any possibility of contamination. The tube or trier should be inserted diagonally
into the bag through a seam or the dog ear to obtain a representative sample of the material from
different sections of the bag. Glass containers should be used to contain the sample. Either a Teflon-
or polyethylene-lined lid may be used for formulation samples.
The used tube and other contaminated sampling material should be disposed of in a satisfactory
manner. The trier should be thoroughly cleaned with soap and water and/or solvent, and dried prior
to reuse.
Pesticides Inspection Manual 11-4 January 1989
-------
Chapter Eleven Pesticide Product Sampling
See Table 11-1 for recommended sample sizes to collect; consult with laboratory if unsure.
(Further guidance is given in Appendix A, NEIC Sampling Guide.)
Liquid Material. A previously unused, disposable type plastic tubing, glass thief or siphon
should be used for each batch or lot sampled to avoid any possibility of contamination when sampling.
(Further guidance is given in Appendix A, NEIC Sampling Guide.)
If the label directions so state, the material should be thoroughly agitated by rolling and shaking
the can, barrel, or drum before sampling. Glass bottles should 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 used tubing and other contaminated sampling material should be
disposed of in a satisfactory manner.
See Table 11-1 for recommended sample sizes to collect; consult with laboratory if unsure.
Labels. A duplicate label, copy, or photograph of the label must accompany each sample. The
label should not be removed from containers, because this will result in the article being misbranded.
Bin labels may be used for this purpose; however, the inspector must make a word-for-word
comparison of this label with the one on the container sampled to be sure they are identical. If labels
are not available from another source, a fully legible photograph(s) of the label is necessary. Another
photograph of the entire container, showing the position of the label on the container, is also to be
obtained.
After Sampling
Restoring Lot to Order
The inspector should 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 reclosed when possible.
Spillage is to be cleaned up and larger containers closed; handtrucks, tools, rags, glue pots, and other
supplies or equipment are returned.
Preparing Duplicate Samples
If the inspected facility requests duplicate samples, they should be collected, identified, and
sealed in the same manner that the official samples were handled. EPA defines a duplicate sample (in
the case of a larger sized unit) as an equal amount of the product taken in the same manner from the
same container. In the case of small-size units, a duplicate sample is defined as the same number of
units taken from the same shipping containers and bearing the same code or batch numbers, if coded.
Although a firm may request half the contents of a small- size unit as their equal portion, small-
size units are not to be subdivided for several reasons:
o The integrity of the sample is more difficult to maintain and defend;
o Contamination during sampling is minimized;
o The possibility of exposure to the inspector and personnel of the firm is diminished; and
o The laboratory can conduct a net content check on the unit collected, if necessary.
Pesticides Inspection Manual 11-5 January 1989
-------
Chapter Eleven Pesticide Product Sampling
Preparing Receipt for Samples
The preparation of the Receipt for Samples (EPA Form 3540-3) should be self-explanatory (see
Exhibit 11-1). 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 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 should be distributed as follows:
o Establishment Copy -- Provided to the facility inspected
o E1R Copy — Attached to the establishment inspection report (see Chapter 9)
o Sample Record Copy — Attached to the Investigation Summary Report. If a receipt covers
more than one sample, it should be attached to the Investigation Summary Report bearing
the lowest sample number
o Collector's Copy -- Retained by the inspector
Payment for Samples
Payment should be offered for samples collected, no matter how small the amount 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. Payment should be
made in cash; reimbursement will normally be made by a travel voucher or by petty cash.
SAMPLE DOCUMENTATION
Authority
Section 8(b) of FIFRA, as amended, provides authority to inspect and copy all records showing
the delivery, movement, or holding of pesticides or devices. Section 12(a)(2)(B) of the Act makes it
unlawful to refuse to allow the inspection of any records pursuant to Section 8.
Objective
Evidence of the government's jurisdiction in the matter must be available before any legal
action can be taken. The official sample serves as evidence of the actual violation; the documentation
serves as evidence of the government's jurisdiction and identifies the responsible party.
Policy
Samples Collected at the Producer
These samples will normally require only minimal documentation, which include (1) FIFRA
Notice of Inspection, (2) FIFRA Receipt of Samples, (3) FIFRA Investigation Summary Report (or
equivalent form). A signed statement and/or copies of correspondence or other records may be
required in unusual circumstances.
Pesticides Inspection Manual 11-6 January 1989
-------
Chapter Eleven Pesticide Product Sampling
Samples Collected in the Marketplace
In addition to those records needed for samples collected at a producer establishment, the
inspector will need to establish the origin and date of shipment of the batch sampled. The producer
and/or shipper, as well as the dealer, is responsible for potential violations found in the marketplace.
The origin and movement of each lot sampled should be documented with shipping records, invoices,
and dealer's statements.
Samples Collected from the User
See Chapter 14 of this manual.
Responsibility
Documentation of samples is to be accomplished in accordance with procedures outlined in this
section. The inspector should be certain that the records obtained are those covering the specific
pesticide products that were sampled.
Do not remove the dealer's only copy of any record. If duplicates are not available, photocopy,
photograph, or hand copy all necessary records. Reproductions should 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 should mark "EPA", the date, and his/her initials in an
inconspicuous manner on the reverse side of all original records from which copies were made. If the
firm's record has information on both sides, the inspector's identification should appear
inconspicuously in a clear space and be circled. These procedures will ensure positive identification
of the document copies in case of question.
For distributor-level violations, the inspector should document the handling and storage of the
sampled product, and establish the source and distribution for any accompanying literature/labeling.
Records Showing Shipment
Records showing shipment of pesticides will normally be required for all samples collected at
locations other than the producer. These records will establish the identity of responsible parties. As
a general rule, the minimum records and documents ordinarily submitted with a sample will consist of
(1) a copy of the invoice covering the sale of the lot to the dealer, (2) copies of the appropriate
transportation records showing shipment, and (3) a statement signed by the dealer, identifying both
the lot sampled and the applicable rec'ords.
Each record copy obtained must be identified as described previously.
Invoice
This document shows the seller's intent to offer the pesticide/device for sale or distribution. It
may provide such information as the value of the goods, carrier, date of shipment, etc. If duplicates or
photocopies of the invoice are unavailable, the invoice shall be photographed or copied by hand on
Section I of EPA Form 3540-13 (see Exhibit 11-2). Other records that may be substituted in the
Pesticides Inspection Manual 11-7 January 1989
-------
Chapter Eleven Pesticide Product Sampling
absence of an invoice are purchase orders, receiving records, canceled checks, and/or
correspondence.
Bill of Lading
The bill of lading (B/L) 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/she acknowledges receipt of the shipment. Note that the date the carrier's agent signs the
B/L is the date of the shipment, and this may or may not be the same date that the B/L is filled out.
The carrier's office in the city of origin of shipment will maintain a copy of the B/L. The following
information is normally found on the B/L:
o The name and address of the shipper,
o The name and address of consignee,
o The date of shipment,
o The name of the carrier,
o Rail car number (if appropriate), and
o A description of the goods.
If duplicate copies or photocopies are unavailable, the inspector should obtain a photograph or
hand copy the B/L on Section II 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 on the B/L, 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 B/L and freight bill into one form. Copies are filed 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 offices should have copies. The pesticide dealer will usually have a freight bill if he/she
received the goods directly.
If necessary, the inspector should obtain a photograph or hand copy the freight bill onto Section
II of EPA Form 3540-13. The type of shipping record should be entered in block 23 of the form.
Sections I and II 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 (see Exhibit 11-2).
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 within 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,
Pesticides Inspection Manual 11-8 January 1989
-------
Chapter Eleven Pesticide Product Sampling
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 II of
EPA Form 3540-13, if duplicate copies or photocopies are unavailable.
Mail or Parcel Service Shipments
Marketplace Sample. The inspector should 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 Sample. When the inspector receives an induced sample directly by mail or parcel
service, the sample documentation should 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
airbill 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.
Shipment by Noncommercial Vehicle
When shipment 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 should obtain a statement
of the facts concerning the shipment. The statement will cover the facts known to him/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.
Dealer's Statements and Affidavits/Statements
Dealer's Statements
This statement is obtained from persons who have dealt with the goods sampled and who know
the facts relating to their 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 identify documents
proving movement of the goods sampled or to name the person who could 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 11-3.
Affidavits/Statements
The affidavit can only be used by EPA inspectors who are authorized to administer oaths,
affirmations, and affidavits. A statement fulfills the same functions as an affidavits but differs in that
it is not given under oath. Affidavits are used for obtaining sworn statements from persons who have
dealt with the sampled goods and who know the facts relating to the movement of such goods or the
events affecting the condition. Such facts, recorded in writing and signed by the person who can
testify in court to those facts, can be used either to establish jurisdiction or fix the responsibility for a
potential violation. Affidavits/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
Pesticides Inspection Manual 11-9 January 1989
-------
Chapter Eleven Pesticide Product Sampling
used when available literature bears pesticide claims or oral representations have been made
regarding the product's use, which are not on the direct labeling. Affidavits/statements are also
employed in use and follow-up investigations when documenting the responsibility for an apparent
violation.
Before the person signs the affidavit, it must be sworn to by asking the person the following:
"Do you swear (or affirm) that this statement is true?" The affidavit is not considered to be valid
unless it is sworn to before it is signed. It is not necessary to use a Bible or to have the signatory raise
his/her right hand. Statements require only the signature of the subject.
Dealer's Affidavit. The Dealer's Affidavit (EPA Form 3540-12) documents the receipt of and
identifies the sampled batch and the related records. All blanks on the form should be completed, as
applicable -- all unused blanks being lined out. Also strike out the words or letters in parentheses,
which are not applicable. Be certain that the signatory reads and understands what he/she is signing.
(See Exhibit 11-4 for a completed Dealer's Affidavit.)
Affidavit/Statement. Unusual situations may present circumstances that do not lend
themselves to presentation on the EPA Form 3540-12. In order to get these unusual facts into an
affidavit/statement that a responsible person can sign, record the events on the appropriate form
(EPA Form 3540-11). There is no prescribed format to be followed in composing the statement. The
facts should be arranged in an order roughly paralleling that of EPA Form 3540-12. Usually, the most
manageable composition will be the 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 (see Exhibit 11-5).
When preparing the affidavit/statement for signature, the inspector should proceed as follows:
o Ascertain all the facts and record those that are material, relevant, and to which the
interviewee can affirm.
o Narrate the facts in the words of the interviewee, using the first person singular.
o Break the statement down into logical paragraphs if it is long and complex.
o Positively identify the interviewee at the beginning of the statement. (It is wise to include
the address and telephone number where he/she can be reached.)
o Give the interviewee's reason why he/she is qualified to make the statement.
o Set forth the pertinent facts in the body of the narrative.
o 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.)
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 in the
affidavit/statement that the product was purchased for intended pesticide use and is either being used
or sold as such.
Pesticides Inspection Manual 11-10 January 1989
-------
Chapter Eleven Pesticide Product Sampling
Refusal to Sign. After the statement has been prepared, it should be read by the potential
signatory or read to him/her before signing, preferably before a witness. If the person refuses to sign,
the inspector should elicit an acknowledgment to the effect that the statement is true and correct.
He/she should 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
affidavit/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 affidavit/statement with his/her name and address.
A copy of the affidavit/statement is to be furnished to the signatory upon request.
Investigation Summary Report
An Investigation Summary Report (Exhibit 9-1) or equivalent will be completed for each
pesticide formulation sample collected. The Region will provide specific instructions on completing
the appropriate form.
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 entitled, "Memorandum to Accompany Investigation Summary Report Sample No.
." A copy of this memorandum will 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. When more than one unit is collected, each unit shall be further identified
with a subnumber or letter. This identification is normally placed on the label of the collected unit.
All collateral labeling, including circulars and inner instruction sheets, should be similarly identified.
Circulars that have been removed from the sample for identification should be reinserted into the
original packages.
Additionally, when identifying larger size unit samples, unless identical bin labels are not
available (these are usually available only at producers), 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:
o Brand name of the product;
o Principal active ingredients and labeled concentrations in percent;
o Company name and address as shown on label;
o Distinguishing marks or code numbers;
o Label 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 plastic
bags); and
Pesticides Inspection Manual 11-11 January 1989
-------
Chapter Eleven
Pesticide Product Sampling
o 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 should
appear as close to the upper right corner as possible.
Accompanying Literature, Labeling, Photographs, and Exhibits
This material should 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 should be placed on the
border. Each photograph should be identified as to which panel of the 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 should also be submitted. If it is a black and white photo, a notation of the
color of the warning statement should 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).
Sample Custody
Samples should be sealed by placing in an inverted plastic bag (4 mil thickness, recommended),
tying a knot, and turning the excess amount of bag back 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 plastic bag provides some degree
of containment in case of breakage or leakage.
Preparing the Official Seal
The official seal (EPA Form 7500-2) should be completed as shown.
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
1 OFFICIAL SAMPLE SEAL
c/J
SAMPLE NO.
SIGNATURE
PRINT NAM
-.
H .
(Inspector. Analyst or "Kchniau))
Pesticides Inspection Manual
11-12
January 1989
-------
Chapter Eleven
Pesticide Product Sampling
Applying the Seal
The official custody seal is then placed just below the knot.
II
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 should then be officially resealed with a
newly completed seal.
Custody
Following collection, documentation, and initiation of chain-of-custody, samples should be
stored in a secure area prior to transfer to the laboratory.
Pesticide product samples can be transferred to the laboratory (given in order of preference)
either by: (1) direct or personal transfer; (2) common carrier (air or surface); or (3) U.S. Postal
Service.
Pesticides Inspection Manual
11-13
January 1989
-------
Chapter Eleven Pesticide Product Sampling
Regardless of which method is employed for sample transfer, several requirements need to be
followed:
o Glass containers must never be packaged directly against each other, either within the
same plastic bag or within the shipping container.
o The sample label, whether for a prepackaged unit or for subsampled material, should
always be readable through the plastic bag.
o Liquid samples should not be packaged with solids in the same outer shipping container.
o A copy of the Investigation Summary Report or equivalent form should be included with
the samples, protected in a protective bag or sleeve.
o 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 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
(Exhibit 11-6). 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.
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 both timeliness and overall reliability. 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.
Because of the continual changing nature of the DOT regulations (given in 49 CFR Parts 100 to
177), the pesticide inspector is advised to obtain a copy of the latest edition to ensure full knowledge
of pertinent additions and amendments. Many pesticides are listed specifically in the Hazardous
Materials Table (49 CFR Section 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 per package, and specific CFR
references for packaging requirements (and exemptions). The Hazardous Materials Table also
contains an appendix, which gives the reportable quantities for certain material (i.e., the quantities
that must be given on the shipping papers, if appropriate, to meet U.S. EPA reportable release
requirements).
Pesticides Inspection Manual 11-14 January 1989
-------
Chapter Eleven Pesticide Product Sampling
For quick reference, the following DOT documents have been reproduced to assist the
inspector in ensuring compliance with DOT requirements:
o Hazardous Materials Definitions (Exhibit 11-7)
o Guide for Shippers (Exhibit 11-8)
o Hazardous Materials Shipping Papers (Exhibit 11-9)
o Sources of Hazardous Materials Markings, Warning Labels, and Placards (Exhibit 11-10)
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: 800-238-5355
United Parcel Service: 800-322-1333
American Labelmark (given in Exhibit 11-11 as Labelmaster) also has a toll-free number (800-
621-5808) to provide advice on shipping hazardous materials, as well as serving a source of packaging
materials, containers, and labels.
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. 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 "Domestic Mail Manual" (Exhibit 11-11).
Pesticides Inspection Manual 11-15 January 1989
-------
Chapter Eleven
Exhibit 11-1
Receipt for Samples
,,o,r<> U.S. ENVIRONMENTAL PROTECTION AGENCY
t A \
1 SSRZJ RECEIPT FOR SAMPLES
v^
NAME OF INDIVIDUAL
FIRM NAME
TITLE
ADDRE
SAMPLE NUMBERS
ADDRESS (EPA Rational O/dce)
DATE
>S (Street, City, State end Zip Code)
SAMPLES COLLECTED (Deecrlbe lully. 1.1, ( Relletretlon, {.of. S.lcft, Model. Sir 111 Number* end olfwr poeltlve identification*.)
The following samples were collected by the U.S. Environmental Protection Agency and receipt is hereby acknow-
ledged persuant 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.
ACKNOWLEDGMENT 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)
TITLE
n DUPLICATE SAMPLES 1 1 DUPLICA1 E SAMPLES SAMPL
REQUESTED AND PROVIDED ! ' NOT REQUESTED
AMOUNT PAID FOR SAMPLES
s
NAME OF COLLECTOR (Prim or type)
1 1 CASH
TITLE OF COLLECTOR
(Owner, Operator or Agent}
ES WERE
SIGNATURE OF COLLECTOR
Pesticides Inspection Manual
11-16
January 1989
-------
Chapter Eleven
Exhibit 11-2
EPA Form 3540-13
COPY OF INVOICE AND SHIPPING RECORD ' "'iTJliainm mm
. LOCATIO'I
Salem, Mass.
John A. Brown 11/14/88
SECTION 1 . COPY OF INVOICE
. »MI»»C« &>•*••. Sum. CHr. tlmlr «IH| IIP COM
A3C Chemical Company
111 First Street
Smith vllle, Pennsylvania 17415
T. IOI.O -TO {•V«me. 5tr*»f. City, St«l* antf IIP eodij
Green Janitor Supply Company
162 Maple Avenue
Salem, Massachusetts 01970
•. IHVOIC C NO.
3Q64
13. QTV 14. UNIT SIZE
40 Cases
10 Cases
It. OUAR ANTEE
None
10. IMVOlCC UATC
10/24/88
• ,Hir»(u PROM (II othrr rllgn Own »
Same
I tMiPKcb TO (II effivr rh*n H«» 1)
Same
XYZ Frelnht Co. 10/24/88
11. DESCRIPTION Or ARTICLE'S! «. UNIT PRICE
Green's Bleach Disinfectant - 24/1 pt.
Green's Bleach Disinfectant - 12/1 qt.
i*.
TOTAL 1
50
95
^
t7. TOTAL
480
114
00
00
594.00
SECTION II . COPY OF SHIPPING RECORD
ABC Chemical Company
111 first Street
Smithville, Pennsylvania 17415
Green Janltov Supply Company
162 Maple Avenue
Salem, Mass achusetts 01970
XYZ Freight Company, Pittsburgh, Pennsylvania
F/B
5fil3 1 in/24/fln
Smithvllle, Pennsylvania 10/24/88
11. DESCRIPTION OF ARTICLEISI
Cleaning Compoun-is
Marv Smith
10/28/88 T»T*«.«
None
J2. NO.PKG:. 11. WCIGHT 34. RATE
50 1250
50 1250
IS. CHARCCS
50
50
00
00
Pesticides Inspection Manual
11-17
January 1989
-------
Chapter Eleven
Exhibit 11-3
Dealer's Statement (EPA Form 3540-19)
DEALER'S STATEMENT
'his certifies-that the sample consisting
JZx IS / trfeCrT*-* L
nlltrtfti hy Inspector ,_/^4 /7 ^,
was from shipment^) received by us fro
feno . A/I/-
«, _D«t. 2, /?*f
hv 7*>C- QrOi^i^ kJQrz*
OAnntfrAoo SAMiuNa
3&/\U#ftf ID. ft >7/7<4 „„ I-IO-&
n <$'/'tfCx7 CJt&STH £,*-&. £t>. .
and was identified to the inspector
/Wfc ^^ •«fA*Lf*™.
7 " / • . fe* •
That the fcopy of) invoicefjt) No. ///
^^ /v^. 30 tfgg
pud (ropy of) shipping rtcordjfl No F/£> 1 OOI
T^iox* ^ / &J?$?
dfltfd w»^CO** -^ i / /Oo
/
,-«u,dhy /?&C PreiGkLUhe, fano . N\S
luhich iu«re identified by rri.&r'tf 4
2,^/7. ^t'C- WAvAqer
and furnished the inspector, cover'this (tfetee) shipment^). ^
Remarfcc- N&H3-'
met fAO OfAu« nut
I/On*
•"•> D ^.
VOUCHOI n mu /
EPA Pon. 3S40.I9 (2-75) BIPLACI. IP* r
ffTflM * Ad*w4
••>
M(n/\ju\ k/Ujuft — '
y/ ~-*fl ' /»
oSciL%UO-4 (4-711 KHICH~MAY •« U^O UNTIt. IUPPLY 11 CXMAUSTKD
Pesticides Inspection Manual
11-18
January 1989
-------
Chapter Eleven Exhibit 11-4
Dealer's Affidavit (EPA Form 3540-12)
UNITED STATES SAMPLE NUMBS*
ENVIRONMENTAL PROTECTION AGENCY
DEALER'S AFF,DAV,T ^01100052.4, 01 01
STATE > COUNTY . CITY
-LllinDlS Cook C.r\irjnqo
Before me, a representative of the United States Environmental Protection Agency, persuant to authority under 43
Statutes-at-Large 803 (7 U.S.C. 2217), Reorganization Plan No. 3 of 1970 (5 U.S.C. at Reorganization Plan Ho. 3 ol
1970), Section 22(a) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 1361.), as amended, and
Environmental Protection Agency Order No. 1255.3, Appendix N-l, as read together, personally appeared
Kk ODtt-fl l\ • U DYMS 1 u in the city, county and state aforesaid, who deposes under oath
or affirmation and says: _. .11
The firm of which I am Vic.fi. r ITJLS lafLflT received "kicked up) on or about
IJttC-SLKTVDlLr IL\IM&& , in response to an order Biven bv MM 5(Ll\
a shipment\) of (product, no. cases, size) 35 C.CVS9.S " Iflj IfluarV 3o»US BiLST Plft-CXCn
from TUo. "&r\HiojrfVl*>kacU Company CaAro .Illinois
' f™ ' f ^ t
via a carrier belonging to \V\n<& loni^orial Supply do. 15H5 M.Clarlc CUicaf "Illinois
Subscribed and sworn to before me (City and State) QjA ( CQ (XO 1 ^—\\ \ f\O V>
. — , . -j i
this \0 day of UQnUQrV • »^1 ,. i
Designated persuant to law to administer oaths, affidavits, and affirmations, Authorization"]^, /V\Ok.V 6 j iTOJ
l^(rvsJUl'B>nrW\
SIGNATURE OF EPA REPRESENTATIVE
EPA Form 3540-1] (R». 5-77) PREVIOUS EDITION MAY BE USED.
Pesticides Inspection Manual 11-19 January 1989
-------
Chapter Eleven
Exhibit 11-5
Affidavit/Statement
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
AFFIDAVIT
UNTY
Lakj.
SAMPLE NUMBER
^0110005010101
CITY
Laki 2_urich
Before me, an employee of the United States Environmental Protection Agency, pursuant to the authority under
43 Statutes-at-Large 803 (7 V.S.C. 2217), Reorganization Plan No. 3 of 1970 (5 U.S.C. at Reorganization Plan
of 1970 No. 3), and Section 22(a) of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. I36t.).
as amended, as read together, personally appeared tf OPT)—PI DUJfj
in the city, county and state aforesaid, who deposes under oath and says:
x* c..
Oxbooo C.V»jLw'ical Cow>pcin\/ tar*. in LaksL Zurich. Two
aopl onia.ro.cl 4/55 tyxlU* cirums
Co.) "
on Nov^^bur
,"XL .
v\OL-Hvt cov^panv's
'
A
arvi
C op
invooa. no
a
n o .
.oz. boiVlt 5? Al-G CiJlfi.
> V^day.
anJl
Al-GCUi
Oxbow CVitmical Co.
594-5 Lakfl. VfiuJ AvJL-
t-ako ZuricU »XL
"TVoJL Mq
r.
lCh } -^- 1 \ 1 fW> I
of "January 19
Designated pursuant to law to administer oaths, affidavits, and affirmations, Authorization
. ^auu-v
ion T|a J^.—I—
SIGNATURE OF tPA EMPLOYEE
PA Form 3540-11 (»-73)
REPLACES PR FORM 5-295 WHICH IS OBSOLETE.
Pesticides Inspection Manual
11-20
January 1989
-------
O.
o
en
>•*
13
tn
8
a
to
BJ
B
B3
X
vo
00
ENVIRONMENTAL PROTECTION AGENCY
Office of Enforcement
PROJ. NO. PROJECT NAME
SAMPLERS: {Signature!
Relinquished by: (Signature)
Relinquished by: (Signature)
Relinquished by: /Signature!
CHAIN OF CUSTODY RECORD
NATIONAL ENFORCEMENT INVESTIGATIONS CENTER
Building 53, Box 25227, Denver Federal Center
Denver, Colorado 80225 •
STATION LOCATION
NO.
OF
CON-
TAINERS
Date/Time
Date /Time
Date /Time
Received by: (Signature)
Received by: (Signature)
Relinquished by: {Signature!
Relinquished by: tSignaturel
REMARKS
Date/Time
Date/Time
Received by: (Signature!
Received by: (Signature)
Received for Laboratory by:
(Signature)
Date /Time
Distribution: Original Accompanies Shipment; Copy to Coordinator Field Files
Remarks
N 2893
o
en
58
o
o
o
cL
o
tr
BJ
T3
r+
O
•1
ca
o
D
S5
BT
-------
Chapter Eleven
Exhibit 11-7
Hazardous Materials Definitions
US Deportment
or Dansportanon
NMeXVCnflnCi
AdrnMstraMon
The following definition
Parta 100-177. Refer to
Hazardous Materials Tabl
not change whether the m
HAZARDOUS MATERIAL -As
Secretsry of Transport at
transported in commerce
MULTIPLE HAZARDS - A mat
position in the lists in
DOT
HAZARD CLASS
CLASS A
CLASS B
CLASS C
BLASTING
AGENT
FLAMMABLE GAS
UN
CLASS
1
1
1
Z
HAZARDOUS MATERIALS DEFINITIONS
B have been abstracted from the Code of Federal Regulations, Title 49, Transportation,
the referenced sections for complete details. Note: In column (1)., Sac. 172.101,
t, the plus (+) fixee the proper shipping name and hazard class. The name end class do
atsrial meets or doea not meet the definition of that class. (Sec. 17Z.101(b)(1))
ubatence or meterial, including a hazardous substance, which has been determined by the
Ion to be capable of posing an unreasonable risk to health, safety, and property when
and which has been to dealgnated. (See Sec. 171.8)
srial meeting the definition of more than one hazard class is classed according to ita
Sac. 173.Z(a) and (b).
DEFINITION
An Explosive - Any chemical compound, mixture, or device which is designed to function
by explosion, that is substantially instantaneous with the release of gaa and heat.
Exception — such compound, mixture, or device which is otherwise specifically
classified in Parts 170-189. (Sea Sec. 173.50)
Detonating or othemise of maximal hazard. The nine types of Clasa A explosives are
defined in Sec. 173.53.
Flammable hazard - In general, functions by rapid burning rather than detonation.
Includes some explosive devices such aa special fireworks, flash powders, etc. (Sec.
173.88)
Minimum hazard - Certain types of fireworks and certain types of manufactured articli
containing restricted quantities of Class A and/or Class B explosives aa components.
(Sec. 173.1(551
A material designed for blasting which has been tested in accordance with Sec.
173.114a(b). It must be so insensitive that there la very little probability of: (1)
accidental explosion o£ (Z) going from burning to detonation. (Sec. 173.114a(b))
Compressed Gaa - Any material or mixture having in-the-container a pressure EXCEEDING
4"ff pels at 70*F., OR a pressure exceeding 104 peia at 130'F.; or any liquid flammable
material having a vapor pressure exceeding 40 psia at 100'F. (Sec. 173.300(a))
Non-liquefied compressed gas ia a gas (other than gas in solution) which, under the
charged pressure, is' entirely gaseous at a temperature of 70*F.
Liquefied compressed gas ia a gas which, under the charged pressure, is partially
liquid at a temperature of 70UF.
Compressed gaa in solution la a compressed gas which ia dissolved in a solvent.
Any compressed gaa meeting criteria aa specified in Sec. 173.300(b) . This includes:
lower flammability limit, flammability limit range, flame projection, or flame
propagation.
Pesticides Inspection Manual
11-22
January 1989
-------
Chapter Eleven
Exhibit 11-7
DOf
HAZARD CLASS
NONFLAMMABLE
CAS
CoMBUSTIBie
LIQUID
FLAMMABLE-
LIQUID
FLAMMABLE
SOLID
ORGANIC
PEROXIDE
OXIDIZER
POISON A
POISON B
IRRITATING
MATERIAL
ETIOLOGIC
AGENT
RAOIOAC1IVE
MATERIAL
CORROSIVE
MATERIAL
ORM-OTHER
REGULATED
MATERIALS
ORM-A
ORM-B
UN
CLASS
2
5
J "
4
5
5
2
&
6
6
7
8
9
9
DEFINITION
Any compressed qaa other than a flammable compressed gas.
Any liquid having a flash point at or above 100T. and below 200T. Authorized flash
point methods are Hated in Sec. l73.1lS(d). Exceptions are round in Sec. 173.115(b).
Any liquid having a riaah point below 100"F. Authorized flash point methods are
listed in Sec. 173.115(d). for exception, see Sec. 173.115(a).
Pyroforic Liquid - Any liquid that ignites apontaneously in dry or moist air at or
below \1ajf. (Sec. 17J.115(c))
Any solid material (other than an explosive) which 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
materials. 'See. 173. ISO)
Spontaneously Combustible Material (Solid) - A solid substance (including sludges and
pastes) which may undergo spontaneous heating or self-burning under normal
transportation conditions. These materials may increase in temperature and ignite
when exposed to air. (Sec. 171.8)
Mater 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. (Sec. 171.8)
An organic compound containing the 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 Sec. 173.151(a).
A aubstance' such as chlorate, permanganate , inorganic peroxide, or a nitrate, that
yields oxygen readily. It accelerates the combustion of organic matter. (See Sec.
173.151)
Extremely Dangerous Poisons •• Poisonous gases or liquids — a very snail amount of the
qes, or vapor of the liquid, mixed with air is danqerous to life. (Sec. 173.3261
Leas Dangerous Poisons - Substances, liquids or solids (including pastes and semi-
aollda), other than Class A or Irritating materials — so toxic (or presumed to be
toxic) to man that they are n hazard to health during transportation. (Sec. 175. >B11
A liquid or solid substsnce which, upon contact with fire or air, gives off dangerous
or intensely irritating fuaen. They do not include any poisonous material. Class A.
(Sec. 173.381)
An "etiologic agent" means a living micro-oroaniam (or its
toxin) which causes (or may cause) nun an disease. (Sec. 173.386)
Any material, or combination of materials, that spontaneously gives off ionizing
radiation. It has a specific activity greater than 0.002 microcuries per gram. -'Sec.
173.403 (See Sec. 173.403(a) through (z) for details)
Any liquid or solid that causes visible destruction or irreversible damage to human
skin tissue. Also, it may be a liquid that has a severe corrosion rate on steel.
(See Sec. 173.240(a) and (b) for details)
(1) Any material that may pose an unreasonable risk to health and safety property when
transported in commerce] and (2) does not meet any of the definitions of the other
hazard classes specified in this subpart: or (3) has been reclassed an ORM
(specifically or permissively) according to this subchapter. (Sec. 173.5QO(a/l
A malarial 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. 'Sec. 173.500(h)(D)
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 ir both of
the following criteria are ORM-8 materials: M) specifically designated by name in
Sec. 172.101 and/or (2) a liquid substance that has a corrosion rate exceeding "I.2SO
inch per yeai- (IPV) on non-clad almtimn. An acceptable test is described in \ACE
Standard TM-01-69. (Sec. 173.500(b)(2))
Pesticides Inspection Manual
11-23
January 1989
-------
Chapter Eleven
Exhibit 11-7
DOT
.HAZMD CLASS
ORM-O
ORH-C
IW
CLASS Ltyinmm
9" T material which has other Inherent characteristics not described sa an OHM-'A or OflH-
B. It is unsuitable for shipment, unless properly identified and prepared for
transportation. Each ORM-C material is specifically named in Sec. 172.101. 'Sec.
173.500(b)(3))
9 A material such as a consumer commodity which presents a limited hazard during
transportation due to its form, quantity and packaging. They must be materials for
which exceptions are provided in Sec. 172.101. A shipping description applicable to
ORM-O material "is found in Sec. 172.101. (Sec. 173.500(b)(4))
9 A material that is not included in any other hazard class, but ia subject to the
requirement*, of this subchapter. Matariala in this class include (1) HAZARDOUS WASTE
(2) HAZARDOUS SUBSTANCE, as defined in Sac. 171.8 (Sec. 173.500(b)(5))
THE FALLOWING ARE OFFERED TO EXPLAIN SOME OF THE ADDITIONAL TERMS USED IN PREPARATION OF HAZARDOUS MATERIALS
TOR SHIPMENT. (Sec. 171.8)
DOT TERM EXPLANATION
CONSUMER
COMMODITY
(SEE (ORM-O
ON PREVIOUS
PAGE)
FLASH PUINf
rWSlbbCN
HAZARDOUS
SUBSTANCE
HAZARDOUS
WASTE
LIMITED
QUANTITY
REMRTABLE
QUANTITY
A material that is packaged or distributed in a form intended and suitable ror sale through
retail sales-type agencies. The material ie for uae by individuals for personal care or
household use. This term also includes drugs and medicines. (Sec. 171.8)
The minimum temperature at which the flammable vapors or a substance (in contact with a spsrK or
flame) will ignite. For liquids, see Sec. 173.115.
Material 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 Sec. 172.101(d)(1)
A material, including its mixtures and solutions, that: (1) Is listed in the Appendix to Sec.
172.101; (2) is in a quantity, in one package, which equals or exceeds the reportable quantity
(RQ) listed in the Appendix to Sec. 1.72.101: (3) When in a mixture or solution, ia 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 Sac. 171.8. This
definition does not apply to petroleum products that are lubricants or fuels. (See 40 CFR 300.6)
Any material that ia (1) subject to the hazardous waste man! feat requirements of the
Environmental Protection Agency specified in the CFR, Title 40, Part 262: or (2) would be
subject to these requirements (in the absence of an interim authorization to a State) see Title
40. CFR, Part 123, Subpart F: 49 CFR 171.8. Questions regarding EPA hazardous waate
regulations, call (202) 554-1404, 554-1405, or 554-1406 in Washington, D.C.
The maximum amount of a hazardous material authorized for specific labeling and packaging
exceptions. Consult the sections applicable to the particular hazard claaa. See Sec. 173.118,
173.118U), 173.153. 173.244, 173.306, 173.345, 173.364 and 173.391.
The quantity specified in Column J of the Appendix to Sec. 17}. 101 for any material identified
in Column 1 of the Appendix.
•THIS HANDOUT IS DESIGNED AS A TRAINING AID FOR ALL INTERESTED PARTIES WHO MAY BECOME INVOLVED WITH HAZARDOUS
MATERIALS. IT DOES NOT RELIEVE PERSONS FROM COMPLYING WITH THE DEPARTMENT OF TRANSPORTATION'S HAZARDOUS
MATERIALS REGULATIONS. SPECIFIC CRITERIA FOR HAZARD CLASSES AND RELATED DEFINITIONS ARE FOUND IN THE CODE OF
FEDERAL REGULATIONS (CFR), TITLE 49, PARTS 100-177.
NOTE: This material nay be reproduced without special permission from this office. Any comments or
recommendations should be sent to:
TRAINING RESOURCES BRANCH, OHM-51
FEDERAL/STATE AND PRIVATE SECTOR INITIATIVES DIVISION
OFFICE OF HAZARDOUS MATERIALS TRANSPORTATION
RESEARCH AND SPECIAL PROGRAMS ADMINISTRATION REVISED October 1987
U.S. DEPARTMENT OF TRANSPORTATION
WASHINGTON, D.C. 20590
Pesticides Inspection Manual
11-24
January 1989
-------
Chapter Eleven
Exhibit 11-8
Guide for Shippers
US Deportment
of TtaPcportQnon
HAZARDOUS MATERIALS TRA>SPORTATION
GUIDE FOR SHIPPERS
Special Progranv
Adinlnltlnillun
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 program to aid compliance with the applicable DOT Regulations.
STEP1 - DETERMINE THE PROPER SHIPPING NAME - The shipper must determine the proper
shipping name of the materials as listed in the Hazardous Materials Table, Sec. 172.101,
Column (2).
STEP 2 - DETERMINE THE HAZARD CLASS OR CLASSES
A. Refer to the Table, Sec. 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 Sec. 173.2.
STEP 3 - SELECT THE PROPER IDENTIFICATION NUMBERS
A. Refer to the Table, Sec. 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 the 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, Sec. 172.101, Column (4) for required label(s).
B. For details on labeling refer to: (1) Additional Labels, Sec. 172.402; (2) Location of
Labels, Sec. 172.406; (3) Packagings (Mixed or Consolidated), Sec. 172.404(a) and (b);
(4) Packages Containing Samples, Sec. 172.402(h); (5) Radioactive Materials, Sec.
172.403; (6) Authorized Label Modifications, Sec. 172.405.
STEP 6 - DETERMINE AND SELECT THE PROPER PACKAGES
A. Refer to the Table, Sec. 172.101, Column 5(a) for exceptions and Column (Sb) for
authorized packagings. Consider the following when selecting an authorized container:
Quantity per package; Cushioning material, if required; Proper closure and reinforce-
ment; 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 (Sec. 172.300); Proper shipping name and ID number, when
required (Sec. 172.301); Name and address of Consignee or Consignor (Sec. 172.306).
B. For details and other required markings, See Sections 172.300 through 172.338.
Pesticides Inspection Manual
11-25
January 1989
-------
Chapter Eleven
Exhibit 11-8
STEP 8 - PREPARE SHIPPING PAPERS
A. The basic requirements for preparing shipping papers include: Proper Shipping name;
Hazard class; ID number; Total quantity; Shipper's certification.
B. Make all entries on the shipping papers using the information required and in proper
sequence (Sec. 172.202).
C. For additional requirements, see Sections 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 are in proper condition for transportation according
to the applicable DOT Regulations (Sec. 172.204).
B. For surface shipment, see Sec. 172.204U) and (b); for air shipments, see Sec. I72.204(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
acordance with the requirements for the 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 carrier personnel do the loading, the carrier is responsible.
STEPU - 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 placardts) and required Identification numbeKs) (Sec. 172.S06).
B. For Rail, if loaded by the shipper, the shipper must placard the rail car if placards are
required. (Sec. 172.508)
C. For Air and Water shipments, the shipper has the responsibility to apply the proper
placards.
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.
"It i:) Lie duty of each person who offers hazardous material* for transportation to instruct each of his
officers, agents, and employees having any responsibility for preparing hazardous materials for
shipment as to the applicable regulations. . ." (Section 173.HW
This r.ieii'is that shippers are required to make certain that those officers, agents and employees who have
any responsibility for preparing or offering hazardous materials for transportation are thoroughly instructed
concerning the regulations as they apply to their job functions.
MOTE; The following suggestions will help to comply with this requirement:
1. Identify all personnel who have hazardous materials transportation responsibilities.
2. Determine what additional instruction or training each needs.
3. Assure that those needing instruction receive it.
4. Maintain record of training.
5. Periodically review training needs in order to maintain the required expertise.
AS A FINAL CHECK AND BEFORE OFFERING THE SHIPMENT FOR TRANSPORTATION, VISUALLY
INSPECT YOUR SHIPMENT.
NOTE; This material may be reproduced without special permission from this office.
recommendations should be sent to:
TRAINING UNIT, DHM-51
FEDERAL/STATE AND PRIVATE SECTOR INITIATIVES DIVISION
OFFICE OF HAZARDOUS MATERIALS TRANSPORTATION
RESEARCH AND SPECIAL PROGRAMS ADMINISTRATION
U.S. DEPARTMENT OF TRANSPORTATION
WASHINGTON, D.C. 20590
Any comments or
Revised June 1987
Pesticides Inspection Manual
11-26
January 1989
-------
Chapter Eleven Exhibit 11-9
Hazardous Materials Shipping Papers
Spsdd Proyonn
GUIDE FOR
HAZARDOUS MATERIALS SHIPPING PAPERS
USE OF GUIDE - This Guide is designed for in-house use when reviewing hazardous material shipping paper
requirements. It does not relieve persons from complying with the Department of Transportation (DOT) Hazardous
Materials Regulations (HMR) . Final authority for use of shipping papers is found in the Code of Federal Regulations
(CFR) Title 49, Parts 100-177.
1. DEFINITIONS
A. 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 containing the information required by 49 CFR 172.202, 172.203
and 172.204.
B. 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. The hazardous waste manifest may be used to satisfy DOT
shipping paper requirements. (49 CFR 172.205).
2. SHIPPER'S RESPONSIBILITY - (49 CFR 172.200U)) The shipper, when offering a hazardous material for transport
has the responsibility to properly prepare the shipping paper.
3. HAZARDOUS MATERIALS DESCRIPTION - (49 CFR 172.202) The shipping description of a hazardous material on a
shipping paper must include the following information:
A. Proper shipping name - MAY NOT BE ABBREVIATED (49 CFR 172.101 or 49 CFR 172.102).
B. The hazard class of the materisl. (See exceptions 49 CFR 172.202(a)(2)
C. The identification number for the material (preceded by "UN" or "NA", as appropriate).
D. Except for empty packagings, cylinders for compressed gases, and packagings of greater than 110 gallon
capacity, the total quantity by weight (net or gross, as appropriate) or volume, including the unit of
measure, of that hazardous material.
E. Except as otherwise provided in the regulations, the basic description must be in the sequence shown in
the 49 CFR 172.101 Hazardous Materials Tsble. For example, "Acetone, Flammable Liquid, UN 1090."
F. The total quantity of the material covered by one description must appear before o£ after (or both before
and after) the basic description.
(1) Abbreviations may be used to specify the type of packaging and unit of measurement of total quantity.
For example, 10 ctns. Paint, Flammable Liquid, UN 1263, 500 Ibs.
(2) Type of packaging and destination marks may be entered in any appropriate manner before or after the
basic description.
G. Technical and chemical group names may be entered in parentheses between the proper shipping name and
hazard class. Example: Corrosive liquid, n.o.s. (capryryl chloride), Corrosive material, UN 1760.
It. GENERAL ENTRIES ON SHIPPING PAPERS - (49 CFR 172.201)
A. Contents - When describing a hazardous material on the shipping paper(s), 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 (See Figure 1 on previous page), or
(b) Must be entered in a contrasting color (or highlighted in a contrasting color) (jr.
(c) Must be identified by the'entry "X" placed before the proper shipping name in a column captioned
"HM." The "X" may be replaced by "RQ" (Reportable Quantity), if appropriate (See Figure 1 on
previous page) .
(2) The required shipping description on the original shipping paper and all copies must be legible and
printed (manually or mechanically) in English.
Pesticides Inspection Manual 11-27 January 1989
-------
Chapter Eleven
Exhibit 11-9
JMSIC DESCIIPTIOUJ
TIM oi 1
e. iiVrttM '""" s"l|"i"1 "'"* 1 1 """' am 1 1 '*"' """"'
nutid. / Xl JUU. 1 /
\ L_ t "*** I/
•'•••••• \ • °"f^"?"?*'yf f •-.."• yr .",:;• -"
10 Oran.Gnilmi. Flnnibli Liquid IMIl'oi ISM Ibl.
40 C|l. Kilroiw, KM-lboitilbll Cn .IW10II 100 Ibt.
1 On*. FUmmiblt Solid, 1.0.1. .IM1J15 4S2 Ibt.
4 loin, tdnttitwi Mitiriil. Pipit. KOI iO Ibt.
1 loll. Pipit Ptintini, Kntptinl (10 Ibt.
12 Silt, Citkon Pipit 22 Ibt.
[cEITIFiOTIOII |
0HUMOOUS IHTUIIU CUTIICS LISTED FUST
uuu
•«i'
IMSIC DECIIPTION!
' A '
TIP! It
Bo Ubtimttd '"•" Skippini «««l
\ I ^
10 Oti.i. Cn^teo. FliMiWi U|iM ,111111
4 8oin. idmtiiioi MiUtiil. Pipit, KOI
1 DtiiB, Fluwblo SolK. H.O.S. .H1J2!
12 Sitt, Cnbon Pipit
40 C|l. «illt|n, Hoo^lKBiil. Ca .UIUOH
| Hund Clttt | Tolll QBinlill |
' fTBSBE^ /
1 .->. J / ^^
S WMOUUITIn f •!«>,> ^)( ?T^
/ -• / -•
i — 4SOO Ibl'
60 Ibl.
— 4S2 Ibl.
22 Ibt.
— 100 Ibl.
r.*.' ..
V71 | «* Cntritt-tootiittini Colon | "oil: liptodoelion ol i
?"± "' i.\,.
| CEITIFICHIOII |
0 HUMOOUS MtniUlS EKTII
HUUdMS PlC
elMnilh .,
HM
CotaM II U
" ~^
,.t-.'r:
4
10
1
12
40
1
Si-
•This ia to certify thet the ebovo-neMd Mterlela «r-
ore properly eleoified, deecribed, pecfceged,
•erked end lebeled, end ire in proper condition
requlotione of the Depertmt of Ireneportetlon"
bifbliihtid OT i hi|hii|hiiii|
pin titbit thin printed in i
contrnlini color.
S«K!««JII»6 COUII
liimo Mil 1
IbbtniiUd I '"'" Sbippiei dim | ] Huitd Clui [ | Tolil Quinliti
"d / / f1ESSSr~| /
\ / / * ,'**** 1 /
~ HM \ -."5fc™.r:,?,'^"^. / ""ii^rr) ss:.' „„ sr?-1
lout, Adnn/lni UlttnlH. / / JJ ^
P.pot.H^.1. / / 7
I Or.mi;CiMli«.. Flim.ibl. li«»iil .UI120! ISM Ibl.
I Otiei, ninmibk Solid, n.oj. ,IW13>S 452 Ibl.
Sib, Ciion pipot 22 Ibl.
I C)l. »iti.|tn. KMllraiuili Cu .UIIlMi 100 Ibl.
loll. Pipn. Priitini, Kenprim 610 Ibt.
. . ... COO ... , 35?, .
• HUMOOUS DtitllUS PIEFIIEO tl "I" III HM COUIMI
R6URE 1. HAZMOOUS IMTEIIIUS LISTED ON SHIPPING PAPERS
Pesticides Inspection Manual
11-28
January 1989
-------
Chapter Eleven Exhibit 11-9
(J) Unless it is specifically authorized or required, the required description may NOT contain any code
or abbreviation.
NOTE: UN=United Nations; NA=North American.
(4) A shipping paper may contain additional information concerning the material provided the information
ia not inconsistent with the required description. The additional information must be pieced after
the basic description required by 49 CFR 172.202(a).
(a) When appropriate, the entries "IMQ" or 1MB Class" may be entered immediately before or_
immediately following the class entry in the baaic description.
(b) If a material meets the definition of more than one hazard clasa, the additional hazard
class(es) may be entered after the hazard class in the bssic 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
hazardous materials by air.
The International Maritime Organization (IMQ) issues the "International Maritime Dangerous Goods
Code (IMDC)" for the international transportation of hazardous materials by water.
The terms "dangerous goods" and "hazardous materials" are considered synonymous.
8. Name of Shipper - A shipping paper for a shipment by wster must contain the name of the shipper.
ADDITIONAL DESCRIPTION REQUIREMENTS (49 CFR 172.203) (ALL MOOES)
A. Exemptions - Each shipping paper issued in connection with shipment made under an exemption must bear the
notation "DOT-E" followed by the exemption number aaaigned (Example: DOT-E4648). Place the exemption
number adjacent to the description to which the exemption applies.
B. Limited Quantitiee - Descriptions for msterials defined aa "Limited Quantities" must include the words
"Limited Quantities" or "Ltd. Qty." following the basic description.
C. Hazardous Substances
(1) If the proper shipping name (for a material that is a hazardous substance) does not identify the
hazardous substance by name, the following shell be entered, in parentheses, in association with the
besic 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 wsste (liquid, sludge, solid, gas) continuously generated from a
manufacturing process. Such waste will be listed in either 40 CFR 261.31 or 40 CFR 261.32, and will
be assigned an EPA waste stream number or
(c) for wastes exhibiting an EPA characteristic of ignitability, corrosivity, or reactivity, or EP
toxicity, the letters "EPA" followed by the word "ignitability," or "corrosivity," or
"reactivity," or "EP toxicity," OR the corresponding "D" number, as appropriate.
(2) The letters "RQ" (Reportable Quantity) shall be entered on the shipping paper either before or after
the basic description required by 49 CFR 172.202 for each hazardous substance. (See definition in 49
CFR 171.8) Example: "RQ, Cresol, Corrosive Material, UN 2076"; or "Hazardous Substance, Solid,
n.o.s., ORM-E, NA 91B8 (Adipic Acid), RQ."
D. Radioactive Materials - For additional description requirements for radioactive materials, refer to 49 CFR
172.203(d).
E. Empty Packaging (49 CFR 172.203(e)) - For empty packaging that still contains a residue of a hazardous
material:
(1) The description on the shipping paper may include the word(s) "RESIDUE" or "RESIDUE: Last Contained
* * * " in association with the basic description of the hazardous material last contained in the
packaging.
(2) For empty tank cars, see 49 CFR 174.25(c).
(3) If a packaging, including a tank car, contains a residue that is a hazardous substance the
description on the shipping paper shall be prefaced with the phrase "RESIDUE: Last Contained * * * "
and shall have "RQ" entered before or after thg basic description.
F. Dangerous When Wet - Packages requiring the label "Dangerous When Wet" shall have the words "Dangerous
When Wet" entered on the shipping paper adjacent to the basic description.
Pesticides Inspection Manual 11-29 January 1989
-------
Chapter Eleven Exhibit 11-9
G. Poisonous Materials - Regardless of the class to which a material is assigned, if the name of the confound
or principal constituent that causes a material to meet the definition of a poison is not included in the
proper shipping name for the material:
(1) The name of the compound or principal constituent shall be entered on the shipping paper adjacent to
the shipping description for the material. The name of the compound or principal constituent may be
either a technical name or any name for the material that is listed in the NIOSH Registry. (Registry
of Toxic Effects of Chemical Substances, 1978 Edition). —
(2) If a liguid or solid material in a package meets the definition of a poison, and that fact is not
disclosed in the shipping name or hazard class, the word "POISON" shall be entered on the shipping
paper in association with the shipping description.
(3) If a material meets the toxicity criteria in 49 CFR 173.3a(b)(2) for the poison by inhalation hazard,
then the words "POISON - Inhalation Hazard" shall be entered on the shipping paper in association
with the shipping description.
NOTE: For additional requirements and exceptions, see 49 CFR 172.203(k).
H. Exceptions: OTHER REGULATED MATERIAL (ORM - A,B,C, and D) Shipping paper reguirements do not apply to
any material (other than a hazardous waste or hazardous substance) that is:
(1) An ORM-A, B, or C unless it is offered or intended for transportation by air or water. Then it is
subject to the regulations pertaining to transportation by air or water as specified in 49 CFR
172.101 (Hazardous Materials Table) or
(2) An ORM-0 unless it is offered or intended for transportation by air.
6. ADDITIONAL MODAL REQUIREMENTS - In addition to the basic reguirements for the shipping papers, each mode has
specific requirements.
A. Transportation by Rail
(1) Shipping Papers (49 CFR 174.24)
(a) Except as provided in paragraph (b) of 49 CFR 174.24, no person may accept for transportation by
rail any regulated hazardous material unless it is accompanied by a shipping paper prepared in a
manner specified in 49 CFR 172.200, 172.201, 172.202, and 172.203. In addition, the shipping
paper must include a certificate, when required by 49 CFR 172.204. If the original shipping
paper containing the certificate is in the originating carrier's possession, no copy of the
certificate is required on the train.
(b) This subpart does not apply to materials classed as ORM-A, 8, C or D unless it is: (a) Hazardous
Substance or (b) Hazardous Waste.
(2) Additional Description for Shipping Papers (49 CFR 172.203(q))
(a) The shipping paper for a rail car containing a hazardous material must contain the notation
"Placarded" followed by the name of the placard required for the rail car.
(b) The shipping paper for each class OOT-113 tank car containing a flammable gas must contain an
appropriate notation, such as "DOT-113A," and the appropriate statement "Do Not Hump or Cut Off
Car While in Motion."
B. Transportation by Air
(1) Shipping Papers Aboard Aircraft (49 CFR 175.35)
During transportation aboard an aircraft, the shipment must be accompanied by a copy of the shipping
papers.
(21 Notification Of Pilot-in-Command (49 CFR 175.33) - Before take off the operator of the aircraft shall
give the pilot-in-command the following information in writing:
(a) Description of hazardous material on shipping papers 49 CFR 172.202 and 172.203.
(b) Total number of packages.
(c) Net quantity or gross weight (See 49 CFR 175.33(a)O) for exceptions).
(d) Location of the hazardous material in the aircraft.
(e) Confirmation that no damaged or leaking packages have been loaded on the aircraft (See 49 CFR
175.30(b) and (c)).
NOTE: The documents required (shipping papers and notification of pilot-in-command) may be
combined into one document provided it is given to the pilot-in-command before departure of
the aircraft. (49 CFR 175.35(b)).
Pesticides Inspection Manual 11-30 January 1989
-------
Chapter Eleven ^^^^^^ ^ ^ ^ Exhibit 11-9
C. Transportation by Water
(1) Shipping Papers (49 CFR 176.24) - A carrier may not transport a hazardous material by vessel unless
the material is properly described on the shipping paper in accordance with 49 CFR Part 172.
(2> Certificate (49 CFR 176.27)
(a) A carrier may not transport a hazardous material by vessel unless he has received a certificate
prepared in accordance with 49 CFR 172.204.
(b) In the case of an import or export shipment of hazardous materials which will not be transported
by rail, highway, or air, the certification may be listed on the bill of lading or other
shipping paper. The shipper must certify that the hazardous material is properly classed,
described, marked, packaged and labeled according to Part 172 or in accordance with the
requirements of the IMDG Code. (See 49 CFR 171.12).
(3) Dangerous Cargo Manifest (49 CFR 176.30) - The carrier (or his authorized representative) shall
prepare a dangerous cargo manifest, list, or stowage plan. This document may only include
material(s) which are subject to the requirements of CFR, Title 49, or the IMDG Code. This document
must be kept in a designated holder on or near the vessel's bridge. (See 49 CFR 176.30 for details).
(4) Exemptions (49 CFR 176.31) - Hazardous material may be transported by vessel under the authority of
an exemption. A copy of the exemption MUST to be on board the vessel. It must be kept with the
dangerous cargo manifest.
(5) Additional Description for Shipping Papers - (49 CFR 172.203(i))
(a) Each shipment by water must have the following additional shipping paper entries:
i. Identification of the type of packages such as barrels, drums, cylinders, and boxes.
ii. The number of each type of package, including those in a freight container or on a pallet.
iii. The gross weight of each type of package OR the individual gross weight of each package.
(b) Shipping papers accompanying "n.o.s." type hazardous materials shipped from the United States by
vessel to any other country must have:
i. For a single hazardous material, the technical name in parentheses after the proper
shipping name. Example, Corrosive liquid, n.o.s. (caprylyl chloride), UN1760.
ii. For a mixture of two or more hazardous materials, include within the parentheses the
technical names of at least two (2) of the most predominately hazardous components.
Example, Flammable liquid, corrosive, n.o.s. (Methyl alcohol, Potassium hydroxide)
Flammable liquid, UN2924.
D. Transportation by Highway
(1) Shipping Papers (49 CFR 177.817)
(a) General - A carrier may not transport a hazardous material unless it is accompanied by a
shipping paper prepared in accordance with 49 CFR 172.201, 172.202 and 172.203.
(b) Shipper's certification - An initial carrier may not accept hazardous materials offered for
transportation unless the shipping paper describing the material includes an accurate shipper's
certification. (49 CFR 172.204). Except for a hazardous waste, the certification is not
required for shipments transported entirely by private carriage nor bulk shipments transported
in a cargo tank supplied by the carrier. (49 CFR 177.817(b))
(c) Changing shipments from highway to rail - When a motor carrier offers or delivers a freight
container or transport vehicle to a rail carrier for further transportation, the following must
be marked on the shipping paper:
i. A description of the freight containar or transport vehicle.
ii. The kind of placard affixed to the freight container or transport vehicle.
(d) Accessibility of shipping papers - Each carrier and driver of the vehicle shall ensure that .he
shipping paper is readily available for inspection and recognizable by authorities in the case
of an accident or for inspection. (See 49 CFR 177.817(e) for details.)
(2) ADDITIONAL DESCRIPTION FOR SHIPPING PAPERS - For Anhydrous ammonia, see 49 CFR 172.203(h)U); fcr
Liquefied petroleum gas, see 49 CFR 172.203(h)(2); and for exemptions, see 49 CFR 172.203(a;.
Pesticides Inspection Manual 11-31 January 1989
-------
Chapter Eleven Exhibit 11-9
7. SHIPPER'S CERTIFICATION (49 CFR 172.204)
A. General
(1) Except aa provided in paragraphs (b) and (c) of 49 CFR 172.204, each person Mho offera a hazardous
material for transportation ahall certify that the material offered for transportation is in
accordance with the regulationa. This requirement is accomplished by printing (manually or
mechanically) the following statement on the shipping paper (See 49 CFR 172.204(a)):
"This is to certify that the above-named materials are properly classified, described, packaged,
marked and labeled, and are in proper condition for transportation according to the applicable
regulationa of the Department of Transportation.*"
NOTE: * The words "herein-named" msy be substituted for the words "above-nsmed."
NOTE: For hazardous waste shipments, the worda "and the EPA" must be added to the end of the
certification. (40 CFR 262.2Kb))
B. Air Transportation
(1) General - Certification containing the following language may be used in place of the certification
required by paragraph A(1) above:
"I hereby 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 applicable national governmental regulations."
(2) Certificate in Duplicate - Each person who offers a hazardous material to an aircraft operator for
transportation by air shall provide two (2) copies of the certificate. (49 CFR 175.30(a)(2))
(3) Passenger and Cargo Aircraft - If hazardoua materials are offered for transportation by air, the
person who offers the hazardoua material must add to the certificate the following statement:
"This shipment is within the limitations prescribed for pasaenger/cargo-only aircraft." (delete non-
applicable)
(4) Radioactive Material - Each person who offers any radioactive material for transportation aboard a
passenger-carrying aircraft shall sign (mechanically or manually) a printed certificate stating that
the shipment contains radioactive material intended for use in, or incident to, research, medical
diagnosis or treatment. (49 CFR 172.204(a)(4))
C. Signature - The certifications required above muat be legibly signed (mechanically or manually) by a
principal, officer, partner or employee of the shipper or hia agent. (49 CFR 172.204(d))
0. Exceptions - Except for s hazardous waste, no certificstion is required for hazardous material offered for
transportation by motor vehicle and transported: (49 CFR 172.204(b)).
(1) In a cargo tank supplied by the carrier or
(2) By the shipper as a private carrier, except for a hazardous material that is to be reshipped or
transferred from one carrier to another.
(3) No certification is required for the return of an empty tank car which previously contsined a
hazardous material and which has not been cleaned or purged.
HAZARDOUS WASTE MANIFEST
The following information has been abstracted from the Code of Federal Regulations (CFR), Title 49, Part 100-177 and
CFR, Title 40, Part 262.
1. DEFINITIONS
A. Hazardous Waste Manifest (40 CFR 262.20) A hazardous waste manifest is a shipping document on which all
hazardous wastes are identified.
B. Shipping Paper - A shipping paper is a bill of lading, manifeat, or other shipping document serving a
similar purpose and containing the information required by 49 CFR 172.202, 172.203 and 172.204.
2. DOT HAZARDOUS MATERIALS MANIFEST REQUIREMENT (49 CFR 172.205)
A. No person msy offer, transport, transfer or deliver a hazardous waste unless a hazardoua waste manifeat is
prepared, signed, carried and given aa required of that person (49 CFR 172.205(a)).
Pesticides Inspection Manual 11-32 January 1989
-------
Chapter Eleven Exhibit 11-9
B. The shipper (generator) must prepare the manifeat in accordance with the EPA Regulations, 40 CFR, Part
262.
C. The original copy of the manifest must be dated by, and bear the handwritten signature of the person
representing the:
(1) Shipper (generator) of waste at the time it is offered for transportation.
(2) Initial carrier accepting the waste for transportation.
0. A copy of the manifest must be dated by, and bear the handwritten signature of the person representing:
(1) Each subsequent carrier accepting the waste for transportation, at the time of acceptance; and
(2) Upon receipt, the designated facility receiving the waate.
E. A copy of the manifeat bearing all required dates and aignature must be:
(1) Given to a person representing each carrier accepting the waste for transportation.
(2) Carried during tranaportation in the same manner aa required for shipping papers.
(3) Given to a person representing the designated facility receiving the waste.
(4) Returned to the shipper (generator) by the carrier that transported the waste from the United States
to a foreign destination with a notation of the date of the departure from the United States.
(5) Retained by the shipper (generator) and by the initial and each subsequent carrier for three (3)
years from the date the waste was accepted by the initial carrier. Each retained copy must bear all
required signatures and dates up to and including those entered by the next person who received the
waste.
F. The requirements of 49 CFR 172.2Q5(d) and E (3) above do not apply to a rail carrier when waste is
delivered to a designated facility by railroad if:
(1) All of the information required to be entered on the manifest (except generator and carrier
identification numbers and the generator's certification) is entered on the shipping paper carried in
accordance with 49 CFR 174.26(c).
(2) The delivering rail carrier obtains and retains a receipt for the waste that is dated and bears the
handwritten signature of the person representing the designated facility.
(3) A copy of the shipping paper is retained for three (3) years by each railroad transporting the waste.
G. The person delivering a hazardous waste to an initial rail carrier shall send a copy of the manifest,
dated and signed by a representative of the rail carrier, to the person representing the designated
facility.
H. A hazardous waste manifest required by 40 CFR Part 262 containing all the information required by 49 CFR
Subpart C (Shipping Papers), may be used as the shipping paper.
3. THE MANIFEST-GENERAL REQUIREMENTS (40 CFR 262.20)
A. A generator (shipper) who .transports, or offers for transportation, hazardous waste for off-site
treatment, storage, or disposal must prepare a manifest before transporting the waste off-site.
B. A generator (shipper) must designate on the manifest one facility which is permitted to handle the waste
described on the manifest.
C. A generator (shipper) msy also designate on the manifest one alternate facility which is permitted to
handle the waste in the event an emergency prevents delivery to the primary designsted facility.
D. If the transporter (carrier) is unable to deliver the waste to the designated facility, the generator must
either designate another facility or instruct the transporter to return the waste.
4. MANIFEST INFORMATION (40 CFR 262.21)
A. The manifest must contain:
(1) Manifest document number.
(2) Generator's (Shipper's) name, mailing address, telephone number, and the EPA identification number.
(3) Name and EPA identification number of each transporter (carrier).
(4) Name, address and EPA identification number of the designsted facility and an alternate facility, if
any;
(5) Description of the waste(s) (e.g. proper shipping name required by 49 CFR 172.101, 172.202, and
172.203.)
(6) Total quantity of each hazardous waste by units of weight or volume, and the type and number of
containers loaded into or onto the transport vehicle.
B. Certification(40 CFR 262.2Kb)) The following certification must appear on the manifest:
"This is to certify that the above named materials are properly classified, described, packaged, marked,
labeled and are in proper condition for transportation according to the applicable regulations of the
Department of Transportation and the EPA."
Pesticides Inspection Manual 11-33 January 1989
-------
Chapter Eleven Exhibit 11-9
5. COPIES OF MANIFEST REQUIRED (40 CFR 262.22)
The manifest must consist of at least the number of copies required to provide the generator (shipper), each
transporter (carrier) and the owner or operator of the designated faciiity with one copy for their records and
another copy to be returned to the owner.
6. USE OF THE MANIFEST (40 CFR 262.23)
A. The generator must:
(1) Sign the manifeat certification by hand.
(2) Obtain the handwritten signature of the initial transporter and date of scceptance of manifest.
(3) Retain one copy in accordance with 40 CFR 262.40(a).
8. The generator mutt give the transporter the remaining copies of the manifeat.
C. For shipment of hazardous waste within the United States solely by water (bulk shipments only) or
railroad, see 40 CFR 262.23(c) and (d).
NOTE: Copies of the manifest are not required for each transporter. For special provisions for water
(bulk shipment only) or rail transporters, See 40 CFR 263.20(e) and (f).
NOTE: This material may be reproduced without special permission from this office. Any comments or
recommendations should be sent to:
Training Resources Branch, OHM-51
Federal/State and Private Sector Initiatives Division
Office of Hazardous Materials Transportation
Research and Special Programs Administration
U.S. Department of Transportation
Washington, D.C. 20590 Revised December 1987
Pesticides Inspection Manual 11-34 January 1989
-------
Chapter Eleven
Exhibit 11-10
Sources of Hazardous Materials Markings,
Warning Labels, and Placards
US Department
of Transportation
Research and
Special Programs
Administration
SOURCES OF HAZARDOUS MATERIALS
MARKINGS, WARNING I.ABELS AND PLACARDS
This listing has been designed as a convenient reference of sources for
purchasing markings (10 numbers on placards or orange panels), labels and
placards for shipment .of hazardous materials. They must comply with the
Code of Federal Regulations, Title 49, Transportation, Parts 100-199, Subpart D -
Marking; Subpart E - Labeling and Subpart F - Placarding, including Appendixes A and B of
Part 173.
It is the responsibility of the shipper and/or transporter to Insure the
proper markings, labels and placards meet the specification requirements.
NOTE: The use of markings (orange panels and ID numbers), labels, and
placards supplied by these sources or any other source by shippers and/or
carriers- does1 not relieve persons from complying with the Department of
Transportation's Hazardous Materials Regulations.
CALIFORNIA
Avery Label Systems1
777 East Foothill Blvd.
Azusa, CA 97102
(818) 969-3311
Beeline, Inc.2
26750 Wattis Way
San Francisco, CA 91702
(415) 471-4100
California Labels, Inc.1
461 North H Street
P. 0. Box 12284
Fresno, CA 93777
(209) 485-1091
800-742-1033 (N. Calif.)
Imperial Marking Systems3
2943 Whipple Road
Union City, CA 84587
(415) 489-5400.
FLORIDA
Creative Products Int1
P. 0. Box 14356
Tampa, FL 33690-0356
(813) 839-6356
MICHIGAN
Label tape Inc.1
P. 0. Box 8823
4275 Airwest Drive, S.E.
Grand Rapids, MI 49508
(616) 698-8890
Quickway Staput, Inc.3
P. 0. Box 1086
Muskegon, MI 49443
(616) 722-2044/739-8950
Whitlam Label Co., Inc.3
6000 R1nke
Warren, MI 40891
(313) 757-5100
MINNESOTA
Dawson Patterson Printing3
Incorporated
223 LaPlata Blvd. East
St. Paul, MN 55101
(612) 222-8445
Meyers Printing Co.1
Change-A-Label Division
500 South Third Street
Minneapolis, MN 55415
1-800-328-4027
(612) 333-8240
OHIO
MPI Labels Systems1
P. 0. Box 70
450 Courtney Road
Sebring, OH 45215
(216) 938-2134
Triangle Label Inc.1
60-A Novner Drive
Cincinnati, OH 45215
(513) 772-5649
TENNESSEE
Artcraft Converters, Inc.1
710 South Fourth Street
Memphis, TN 38101
(901) 525-1441
VIRGINIA
American Trucking Assoc.1
Customer Service Dept.
2200 Mi 11 Road
Alexandria, VA 22314
(703) 838-1754
Pesticides Inspection Manual
11-35
January 1989
-------
Chapter Eleven
Exhibit 11-10
GEORGIA
Southeastern Label Co.3
P.O.Box 81386
Chamblee, GA 30366
(404) 455-8816
HAWAII
Safety Systems Hawaii3
302 Mokauea Street
Honolulu, HI 96819
(808) 847-4018
ILLINOIS
Labelmaster3
5724 N. Wolcott Avenue
Chicago, IL 60646
800-621-5808
(312) 478-0900
Legible Signs, Inc.3
2221 Nlraitz Road
Rockford, IL 61111
(815) 654-0100
Wai 1 ace
Computer Services, Inc.
4600 W. Roosevelt Road
Hillside, Illinois 60162
(312) 449-8600
Related Products, Inc.1
3223 N. Western Avenue
Chicago, IL 60618
(312) 528-2900
NEW JERSEY
Ever Ready Label Corp.
357 Cortlandt Street
Belleville, NJ 07109
(201) 759-5500
Lawrence Packaging Supply3
113 North 13th Street
Newark, NJ 07107
(201) 485-4400
(212) 962-4393 (NY)
Mar-Kal Products Corp.3
105 Walnut Street
Montelair, NJ 07042
(201) 783-7155
Prest-On Products, Inc.3
870 Springfield Road
Union, NJ 07083
(201) 851-9777
UNZ and Company3
190 Baldwin Avenue
Jersey City, NJ 07306
800-631-3098
(201) 795-5400
(212) 344-2270 (NY)
NORTH CAROLINA
Soabar Graphics
P. 0. Box J
2305 Soabar Drive
Greensboro, NC 27402
(919) 275-9371
TEXAS
Carl ton Label & Decal
3150 Nasa Road One
Seabrook, TX 75222
(713) 334-1543
(800) 231-5988
Contact Products, Inc.3
P.O. Box 220063
Dallas, Texas 75222
(214) 231-6367
WISCONSIN
W. H. Brady Co.3
727 W. Gl end ale Avenue
P. 0. Box 571
Milwaukee, WI 53501
(414) 961-2253
J. J. Keller3
145 W. Wisconsin Avenue
Neenah. WI 54956
(414) 722-2848
1-800-558-5011
CANADA
HI Signs MFG LTD 3
4403 - 84th Avenue
Edmonton, Alberta
Canada T6B 256
(403) 468-6181
1 - Labels Only 2 - Placards Only
3 - Labels and Placards
NOTE: Companies not listed, but would like to be placed on this listing must submit
samples of their labels, placards, or markings (ID numbers) for evaluation to the
attention of the address below.
NOTE: THIS MATERIAL MAY BE REPRODUCED WITHOUT OBTAINING SPECIAL PERMISSION FROM THIS OFFICE.
Training Unit, DHM-51
Federal, State, and Private Sector
Initiatives Division
Office of Hazardous Materials Transportation
Research and Special Programs Administration
US Department of Transportation
Washington, DC 20590
REV. AUGUST 1986
Pesticides Inspection Manual
11-36
January 1989
-------
Chapter Eleven Exhibit 11-11
Mailability of Hazardous Materials
MAILABILITY OF HAZARDOUS MATERIALS
(Adopted from "Domestic Mail Manual", U.S. Postal Service)
124.331 Flammable Liquids
a. Flammable liquids and semiliquids with a flash point of 20 degrees F (-6.7 degrees C)
(closed-cup) or below are nonmailable. If the flash point is above 20 degrees F and (-6.7
degrees C) up to 73 degrees F (23 degrees C) (closed-cup), the item may be accepted in the
domestic surface mail.
b. Flammable liquids must be in metal containers not over 1-quart capacity or in other
containers not over 1-pint capacity, each packed in a strong outside container. Packages must be
plainly and durably marked on at least one side with the proper shipping name of the flammable
liquid. Flammable liquids are not acceptable for air transportation or international mail.
c. Flammable liquids with a flashpoint at or above 73 degrees F (23 degrees C), but less
than 100 degrees F (37.8 degrees C) are acceptable for domestic surface transportation only,
subject to the 1 gallon restriction described in 124.332c.
124.332 Combustible Liquids
a. Combustible liquids with a flash point at or above 100 degrees F (37.8 degrees C) but
no higher than 141 degrees F (60.5 degrees C) (closed-cup), may also be accepted for domestic
surface transportation, subject to the 1 gallon quantity restrictions described in b and c below.
b. Combustible liquids with a flash point above 141 degrees F (60.5 degrees C) up to and
including 200 degrees F (93.3 degrees C) (closed-cup) may be accepted for domestic surface or
air transportation, subject to the quantity restrictions described below. There are no
restrictions for liquids with a flash point above 200 degrees F (93.3 degrees C) (closed-cup).
c. Containers of combustible, or flammable, liquids described in this section must not
exceed 1 gallon, and each must be packed in a strong outside container. For domestic air
transportation, each outside container must have sufficient absorbent cushioning within to
absorb all leakage. The cushioning material and primary container must be enclosed within
another sealed container within the outside container, and the flash point must be listed on the
outside of the parcel. Combustible liquids are not acceptable in international mail.
124.334 Oxidizers. An oxidizer is a substance such as a chlorate, permanganate, inorganic
peroxide, or a nitrate, which yields oxygen readily to stimulate the combustion of organic
matter. Oxidizers must be enclosed within inside containers having a rated capacity of 1 pint or
less for liquids or a net weight of 1 pound or less for solids and be packed in strong outside
containers, having a net weight of 25 pounds or less. Packages must be plainly and durably
marked on at least one side or end with the proper shipping name of the oxidizer. when
specifically permitted in domestic air transportation (see 124.13), packages of oxidizers must
also be accompanied by a shipper's declaration for dangerous goods, along with the designation
"ORM-D AIR." Oxidizers are not acceptable in international mail.
Pesticides Inspection Manual 11-37 January 1989
-------
Chapter Eleven Exhibit 11-11
124.34 Corrosives
124.341 General. A corrosive material is a liquid or solid which causes visible
destruction or irreversible alterations in human skin tissue at the site of contact or a liquid
which has a severe corrosion rate on steel. Corrosives are not acceptable for mailing,
except as specified herein for Consumer Commodity, ORM-D material. Packages must be
plainly and durably marked on at least one side with the proper shipping name of the
corrosive. A shipper's declaration for dangerous goods is required for air transportation,
along with the designation "ORM-D AIR." Corrosives are not acceptable in international
mail.
124.342 Corrosive Liquids, to be acceptable, liquid mixtures must contain 15 percent
or less corrosive material with the remainder of the mixture not being a hazardous
material, unless otherwise specified for a specific corrosive liquid. Corrosive liquid
mixtures are limited to 1 pint or less. Containers must be compatible glass bottles enclosed
within metal or plastic containers, each packed within an outside container.
124.343 Corrosive Solids, to be acceptable, the solid mixture must contain 10 percent
or less corrosive material, with the remainder of the mixture not being a hazardous
material, unless otherwise specified for a specific corrosive solid. Corrosive solid mixtures
are limited to a net weight of 10 pounds or less in inside containers. These containers must
be compatible sif tproof containers, packed in strong outside sif tproof containers, not to
exceed 25 pounds.
124.362 Generally Nonmailable. Except under the conditions specified in this section,
poisons are nonmailable matter and shall not be conveyed in the mail or delivered from any
post office, branch, or station thereof nor by any letter carrier. Poisons are not acceptable
in international mail.
124.363 Authorized Mailings
a. Class B Poisons for Scientific Use. Class B poisons for scientific use, which are
not outwardly or of their own force dangerous or injurious to life, health, or property, may
be shipped only between manufacturers, dealers, bona fide research or experimental
scientific laboratories, and employees of the Federal, state, or local governments who have
official use for such poisons. Any such employee must be designated by the head of his
agency to receive or send such poisons.
b. Class B Poisonous Drugs and Medicines. Class B poisonous drugs and medicines
may be shipped only from the manufacturer thereof or dealer therein to licensed
physicians, surgeons, dentists, pharmacists, druggists, cosmetologists, barbers, and
veterinarians (18 U.S.C. 1716)
c. Class B Poisons. Class B poisons mailable between persons authorized in 123.363a
and b are restricted to 8 ounces, and must be marked with the proper shipping name of the
poison. A shipper's declaration for dangerous goods is also required for air transportation,
along with the designation "ORM-D AIR."
Pesticides Inspection Manual 11-38 January 1989
-------
Stop Sale, Use, or Removal
Orders
-------
Chapter Twelve
STOP SALE, USE, OR REMOVAL ORDERS
Page No.
AUTHORITY 1
Stop Sale, Use, or Removal Orders 1
Seizures 1
OBJECTIVES
POLICY
PROCEDURES 2
Service of Order by U.S. Mail 2
Regional Office 2
Headquarters 2
Service of Order by Inspector 2
Refusal to Accept Order 2
Disposition 3
Violations of Orders 3
Pesticides Inspection Manual 12-i Janaury 1989
-------
Chapter Twelve Stop Sale, Use, or Removal Orders
Pesticides Inspection Manual 12-n Janaury 1989
-------
Chapter Twelve
STOP SALE, USE, OR REMOVAL ORDERS
AUTHORITY
Stop Sale, Use, or Removal Orders
Section 13(a) of the FIFRA, as amended, authorizes the Administrator to issue a written or
printed Stop Sale, Use or Removal Order 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. Stop Sale, Use or Removal Orders are also issued
when any pesticide or device that has been or is intended to be distributed or sold in violation of the
Act, or when the registration of a pesticide has been canceled by a final order or has been suspended
under Section 3(c)(2)(B) or 6 of the Act. After a Stop Sale, Use, or Removal Order 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.
Seizures
Section 13(b) of the FIFRA, as amended, authorizes the seizure of any pesticide or device for
confiscation and condemnation in any federal district. This process, rarely used, is described in the
FIFRA Compliance/Enforcement Guidance Manual.
OBJECTIVES
The objective of a Stop Sale, Use or Removal Order is to prevent the sale, use or removal of any
pesticide or device found to be in violation or being used in violation of any provision of the Act.
POLICY
The policy of EPA is to issue Stop Sale, Use and Removal Orders whenever possible because
they are the most effective and efficient legal tool available for protecting humans and the
environment. The criteria for the issuance of Stop Sale, Use, and Removal Order may be found in
Chapter Five of the FIFRA Compliance/Enforcement Guidance Manual.
Pesticides Inspection Manual 12-1 Janaury 1989
-------
Chapter Twelve Stop Sale, Use, or Removal Orders
PROCEDURES
Service of Order by U.S. 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 or a suspension action under
Section (3)(c)(2)(B) of the Act, EPA Headquarters may elect to issue the order. Any such orders will
be served via U.S. certified mail.
Service of Order by Inspector
Stop Sale, Use and Removal Orders may be served by an inspector in certain circumstances.
The order will be as specific as possible to identify the pesticide or device including the batch or
code numbers and the violations. The order must also be specific as to the date it is delivered. The
inspector will determine the amount of the product that is under the control of the person to whom
the order is served.
Before the order is presented to the custodian of the product, the inspector should explain to
the recipient the scope and meaning of the order and the obligation which it places on him/her as
recipient. The explanation should include the fact that the product covered by order cannot be sold,
used or removed unless directed by a further order issued by the regional office. The inspector should
also point out the name of the regional contact person (named in the order).
The inspector will also follow any regional policies regarding the serving of such orders.
Refusal to Accept Order
In the event that the person on 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:
o The order becomes effective when delivered and is binding on the recipient whether or not
he/she accepts it;
o The recipient has the prerogative of discussing the order with the contact person at the
regional office who is named in the order.
o The recipient is liable for a civil or criminal penalty for violating the terms of the order as
well as for the violation itself; and
The inspector should make a detailed record in his/her diary of this conversation and his/her
actions for possible use at any subsequent hearing or court action.
Pesticides Inspection Manual 12-2 Janaury 1989
-------
Chapter Twelve Stop Sale, Use, or Removal Orders
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 shall proceed as follows:
o Report the violation to the regional office immediately; and
o 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.
Pesticides Inspection Manual 12-3 Janaury 1989
-------
Chapter Twelve Stop Sale, Use, or Removal Orders
Pesticides Inspection Manual 12-4 Janaury 1989
-------
Recalls
-------
Chapter Thirteen
RECALL
Page No.
RECALL 1
Pesticides Inspection Manual 13-i January 1989
-------
Chapter Thirteen Recall
Pesticides Inspection Manual 13-ii January 1989
-------
Chapter Thirteen
RECALL
RECALL
In general, if a registration of a pesticide has been suspended and cancelled, and EPA finds that
a recall is necessary to protect public health or the environment, a recall must be conducted. EPA is
authorized to allow two types of recall -- voluntary and mandatory.
The EPA may order a voluntary recall if that action will be sufficient to protect health or the
environment. If not, mandatory recall procedures issued as a regulation under Sections 19(b)(3) and
(4) may require registrants, distributors, or sellers of a pesticide to make available storage facilities to
accept and store existing stocks of the suspended arid cancelled pesticide and to inform the adminis-
trator of the location of the facility. The parties subject to the recall must also provide transportation of
the pesticide, on request; and take reasonable steps to inform holders of the recall and transportation
provisions.
The Agency is also authorized to require evidence of financial or other capability to conduct this
recall procedure. The criteria for the recall plans will be issued under Section 19(b) through the 40
CFR Part 165.
Additional information on recalls will be provided in future updates to this manual.
Pesticides Inspection Manual 13-1 January 1989
-------
Chapter Thirteen Recall
Pesticides Inspection Manual 13-2 January 1989
-------
Use/Follow-Up Enforcement
Investigations
-------
Chapter Fourteen
USE/FOLLOW-UP ENFORCEMENT INVESTIGATIONS
Page No.
AUTHORITY 1
Introduction 1
Statutory Basis 1
Consent 2
Open Fields 2
Exigent Circumstances 2
Plain View 2
OBJECTIVES 3
POLICY 3
USE INSPECTIONS 3
Inspector Obligations and Procedures 4
Conducting the Inspection 4
Sampling 4
Types of Samples 5
Documentary Sample 5
Formulation Samples 5
Diluted Material 5
Residue Samples 5
Specific Sampling Procedures 5
Records 5
Discussion with Owner/Operator, Applicator, or Agent in Charge 5
FOLLOW-UP INVESTIGATIONS 6
Inspector Obligations and Procedures 6
Conducting the Investigation 6
Sampling 7
Records 7
Report 7
Exhibit 14-1: Notice of Use/Misuse Inspections 9
Exhibit 14-2: Use Investigation Report (EPA From 3540-20) 10
Exhibit 14-3: Receipt for Use/Misuse Samples 11
APPENDIX: Pesticide Sampling Procedures
Pesticides Inspection Manual 14-i January 1989
-------
Chapter Fourteen Use/Follow-Up Enforcement Investigations
Pesticides Inspection Manual 14-ii January 1989
-------
Chapter Fourteen
USE/FOLLOW-UP ENFORCEMENT INVESTIGATIONS
AUTHORITY
Introduction
Use and follow-up inspections 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 inspector right of
entry to conduct the 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
o FIFRA Section 12(a)(2)(G): "To use any registered pesticide in a manner inconsistent
with its labeling;"
o FIFRA Section 2(ee): "To use any registered pesticide in a manner inconsistent with its
labeling." -- 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:
Provided, that the term shall not include (1) applying a pesticide at a dosage,
concentration, or frequency less than that specified on the labeling, (2) 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, (3) employing any
method of application not prohibited by the labeling, (4) mixing a pesticide or pesticides
with a fertilizer when such mixture is not prohibited by the labeling, (5) any use of a
pesticide in conf ormance with section 5, 18, or 24 of this Act, or (6) any use of a pesticide
in a manner that the Administrator determines to be consistent with the purposes of the
Act. After March 31, 1979, the term shall not include the use of a pesticide for agricultural
or forestry purposes at a dilution less than label dosage unless before or after that date the
Administrator issues a regulation or advisory opinion consistent with the study provided
for in section 27(b) of the Federal Pesticide Act of 1978, which regulation or advisory
opinion specifically requires the use of definite amounts of dilution.
Pesticides Inspection Manual 14-1 January 1989
-------
Chapter Fourteen Use/Follow-Up Enforcement Investigations
40 CFR Section 162.3(oo): "The term 'use' means any act of handling or release of a
pesticide, or exposure of man or the environment to a pesticide through acts, including but
not limited to: (1) Application of pesticide, including mixing and loading and any required
supervisory action in or near the area of application; (2) Storage actions for pesticides and
pesticide containers; and (3) Disposal actions for pesticides and pesticide containers.
"[Use as defined here incorporates application. However, the certification requirement for
certain restricted use pesticides only applies with respect to applications of such pesticides.
Many aspects of use do not include application (e.g. storage, transportation), and hence
are outside the requirement for certification.]"
Consent
Entry to conduct investigations is authorized pursuant to a 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, such knowledge may be helpful in validating the consent and in
overcoming any taint of implied coercion. In addition, the person granting the consent must be
authorized to do so. The inspector should 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, it is imperative
that consent be gained at 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 should 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 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. 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 criminal 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 should 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
Pesticides Inspection Manual 14-2 January 1989
-------
Chapter Fourteen Use/Follow-Up Enforcement Investigations
occurring around him/her. This principle applies regardless of the nature of the inspection (use,
producer, marketplace, etc.). Three elements are required for a plain view observation:
o 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."
0 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.
o 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
0 To protect health and the environment;
o To determine compliance with FIFRA; and
0 To collect information for use by the Agency to determine the need for pesticide label and
labeling changes.
POLICY
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.
USE INSPECTIONS
Use inspections encompass a wide variety of pesticide use circumstances and inspection sites.
They are conducted at the discretion of the Agency and/or inspector. Although many aspects of
pesticide compliance are involved, the primary focus is on use inconsistent with the label. Inspection
sites include, but are not limited to the following areas of pesticide use:
o Agricultural (commercial and private)
Field crops
Orchards/groves
Greenhouses/nurseries
Sod farms
Forests
Vegetable and specialty crops
Grain elevators
o Nonagricultural (commercial, public, and not-f or-hire)
Structural pest control
Rights-of-way
Aquatic environments
Hospitals/nursing homes/clinics
Pesticides Inspection Manual 14-3 January 1989
-------
Chapter Fourteen Use/Follow-Up Enforcement Investigations
Veterinarians
Lawns, ornamentals, and golf courses
Use inspections can be initiated at either the site of application or the applicator's place of
business.
Inspector Obligations and Procedures
The inspector should seek the most responsible individual available at the inspection site and
present his/her credentials to that person. Before beginning any use investigation, the owner,
operator, or agent in charge should be issued a written Notice of Use/Misuse Inspection (Exhibit 14-
1). The notice should 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 should immediately notify his/her supervisor.
Conducting the Inspection
The inspector should obtain the relevant information necessary to complete a narrative report
of the inspection. This information includes, but is not limited to, the following:
o Name, address and telephone number of the applicator, business, and/or person
interviewed.
o Names and titles of principal officers, partners, or owners (if appropriate).
o Pesticides:
Brand name(s), EPA Reg. No(s)., and classification of pesticide(s) used.
Label reviews (storage, safety equipment, disposal, mixing/loading, etc.)
o Use
Crop, area, or object treated Precautionary Directions
Method of Application Environmental Precautions
Rate of Application Transportation/Storage
Disposal (Rinsate/Containers) Re-Entry Interval
Mixing Loading Instructions Preharvest Interval
Dilutant/Additives Spray Intervals
Protective Clothing/Equipment Classification
Calibration Procedures Weather Conditions
The Use Investigation Report (EPA Form 3540-20), or equivalent, may be used to assist the
inspector in documenting use information (Exhibit 14-2).
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 diluted and applied. It is essential
to collect samples (DOC or PHY) of any/all pesticides suspected of having been misused.
Pesticides Inspection Manual 14-4 January 1989
-------
Chapter Fourteen Use/Follow-Up Enforcement Investigations
Types of Samples
Documentary Sample. A DOC of suspect pesticides should be collected if physical samples are
not available or in those circumstances where no problem with the chemistry of the pesticide is
suspected.
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 should be taken to determine whether it was misformulated. A formulation sample should
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 should be made to collect a sample at the
dealer/distributor level. If it is necessary to obtain a sample from a previously opened container, the
investigator should obtain an affidavit/statement from the user stating that the product has not been
altered. (See Chapter 11 for Sampling Methodology.)
Diluted Material. Pesticides diluted or mixed for use should 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 should be collected only when overmixing or improper pesticide selection is suspected.
A copy of the registered product's pesticide label should be obtained to accompany the sample
of diluted material. If a label or photograph of the label cannot be obtained to accompany the sample,
the pertinent portions of the label (ingredient statement and applicable dilution/mixing directions)
should be hand-written and attached to the sample. If not observed first hand, an affidavit/statement
should 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 should
be obtained regarding the type of application equipment used and its calibration.
Residue Samples. Residue samples include plant materials, animal tissues, soil, drinking water,
surfaces, air, runoff water, etc. A residue sample should be collected when there is reason to believe
that a pesticide has been misapplied.
Specific Sampling Procedures. Refer to the NEIC Pesticide Sampling Guide (included in the
appendix to this chapter) and Chapter 11.
Records
Determine what records are being maintained by the applicator/firm, review pertinent records,
and document all apparent violations.
Discussion with Owner/Operator, Applicator, or Agent in Charge
The inspector should 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 the FIFRA, (2) the
importance of following label directions, (3) the need to use pesticides safely, and (3) the need to
protect human health and the environment by observing all label precautions during all phases of use,
including mixing, application, storage, and disposal.
Pesticides Inspection Manual 14-5 January 1989
-------
Chapter Fourteen Use/Follow-Up Enforcement Investigations
The inspector should give the owner, operator, applicator, or agent in charge of the
establishment a copy of the completed and signed Receipt for Use/Misuse Samples (Exhibit 14-3) for
any samples taken.
The results of the inspection should be discussed with management. Any problems or
discrepancies noted during the inspection should be brought to the attention of the
applicator/management so that immediate corrective action may be taken. The inspector should
explain that violations may be found by the laboratory and/or regional office.
The inspector should note in the Inspection Report any voluntary corrective actions.
FOLLOW-UP INVESTIGATIONS
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 more passive, as in the context
of a use inspection, to a more investigative role.
Follow-up investigations tend to be more complex than use investigations, 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. Parties involved in an
investigation may include, but are not limited to, the following:
Complainants Physicians/Veterinarians
Applicators Pesticide Dealers/Distributors
Eye witnesses Other Federal, State and/or Local Agencies
Cooperative Extension Agents Other "Experts" and/or Operators
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 a complaint. Credentials should 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 should be used where pesticides are held for distribution or sale. A
Notice of Use/Misuse Inspection should be used at other locations. (Refer to Chapter 9 and Chapter
14, Use Inspections.)
Conducting the Investigation
The inspector should interview, at a minimum, the complainant and the applicator. When
interviewing the applicator, the procedures outlined in this section should be followed. Additional
interviews should be conducted as necessary.
In conducting a follow-up investigation, it will be necessary to gather sufficient documentary
and physical evidence to support any alleged charges of violations of FIFRA. This evidence may
include the following:
o Photographs, originals or copies of labels and labeling for pesticides used;
Pesticides Inspection Manual 14-6 January 1989
-------
Chapter Fourteen Use/Follow-Up Enforcement Investigations
o Photographs or video tapes showing actual pesticide misuse or damage caused by an
alleged misuse;
o Affidavits/statements from the property owner, applicator, owner/operator, or witnesses
that attest to the relevant circumstances;
o Copies of any available investigation reports completed by other agencies or companies
including state and local agencies, insurance companies, etc.;
o Sketches or maps of the area treated and surrounding properties; and
o Samples (PHY and DOC).
Sampling
Refer to Chapter 14 (Conducting the Inspection), Chapter 11, and the appendix to Chapter 14.
Records
The inspector should determine what records are routinely maintained by the
applicator/responsible firm. Pertinent records should be reviewed and all apparent violations should
be documented.
It may be necessary to collect copies of other records, including but not limited to, the
following:
o Written recommendations (advisor, consultants, CES bulletins, etc.)
o State and/or locally required permits and/or notifications
o Weather records
o Certification/licensing records
o Additional labeling (Supplemental Labels)
o Regulations/standards
o Medical Records'
Report
A narrative report should be submitted as soon as possible following the completion of the
investigation. At a minimum, the report should indicate whether a pesticide was involved. If so, what
pesticide was used, where was it applied (site/crop), how was it applied (method, dilution rate,
' A signed Authorization for Release of Medical Records must be obtained from the subject prior
to obtaining medical records.
Pesticides Inspection Manual 14-7 January 1989
-------
Chapter Fourteen Use/Follow-Up Enforcement Investigations
application rate, application equipment, safety equipment, etc.), weather conditions, if appropriate,
who the responsible party was, and when the pesticide was applied. In addition, the report should
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 should be attached to the narrative report
as exhibits. The report should be limited to factual information.
A good reference for preparing narrative (or narrative portions of) investigation reports is the
Student Text on Report Writing (#303) prepared by the Treasury Department for the Federal Law
Enforcement Training Center. Copies of this document are available from the U.S. EPA-NEIC
Library by calling (303) 236-5122 or FTS 8-776-5122.
Pesticides Inspection Manual 14-8 January 1989
-------
Chapter Fourteen
Exhibit 14-1
Notice of Use/Misuse Inspection
•ft U.S. GOVERNMENT PRINTING OFFICE: 1979-622-911
ji«»"»j^ u-s- ENVIRONMENTAL PROTECTIO
( ^1*7 } NOTICE OF PESTICIC
VT*4*^ USE/MISUSE INSPECT
NAME Or INDIVIUAL
SIGNATURE OF EPA EMPLOYEE
ADDRESS (EPA R»(lon«f Of/let;
N AGENCY
>E
wr* DATE HOUR AM
PM
TITLE
ADDRESS (Number, 5fr«er, City. Stmto and ZIP code)
TITLE
REASON FOR INSPECTION
1 ' For 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 Insecticide. Fungicide,
and Rodenticide Act.
| 1 For the purpose of inspecting sites where pesticides have been used to determine whether the pesticides were
used in compliance with the Federal Insecticide, Fungicide, and Rodenticide Act.
VIOLATION SUSPECTED:
CONSENT
12~2 Voluntary Consent Necessary to
The undersigned hereby voluntarily <
of which 1 am Owner, Agent or Perso
in connection wl(Ji the administratioi
consent to tnis entry.
SIGNATURE
EPA Form 3540-25 (3-77)
inter for Inspection and/or Sampling
Consents to an inspection of ... . ,
n-In-Charge, for the purposes of gathering information and/or samples
i and enforcement of FIFRA. I understand that I have the right to refuse
TITLE DATE
ORIGINAL t-USE REPORT COPV
2*OWNER/AOENT COPY
3-REGION COPY
4-INSPECTOR'S COPY
Pesticide Inspection Manual
14-9
January 1989
-------
Chapter Fourteen
Exhibit 14-2
Use Investigation Report (EPA Form 3540-20)
USE INVESTIGATION REPORT
i.
1. NAME
b. ADDRESS
C. TELEPHONE
3.
1. NAME
C. TELEPHONE
3.
t. NAME
APPLICATOR
b. ADDRESS
d. CERTIFICATION NUMBER
SITE OF APPLICATION
b. ADDRESS
C. TELEPHONE
d. TYPE OF BUSINESS
f. TARGET PEST
t. CROP, AREA OR OBJECT TREATED
g. DATE AND TIME OF APPLICATION
n. WEATHER AT TIME OF APPLICATION (Wind, temperature, humidity, rain, etc., lilt tource of in forma Holt /
4.
1. BRAND NAME
•. TYPE OF FORMULATION
CH DUST CH SPRAY
5.
a. METHOD OF APPLICATION
CD QROUND Q AERIAL
PESTICIDE APPLIED
b. EPA REG. NO. C. BATCH NO. d. CLASSIFICATION
CH GRANULAR CD MIST d FOG CJ OTHER (Specify/:
RATE OF APPLICATION
Q OTHER (Specify/:
b. DILUTION RATE
C. DILUTED MATERIAL APPLIED PER UNIT (Galloni/Acref d. ACTUAL ACTIVE PER UNIT (LblfAcrel
6.
1. FORMULATION
SAMPLES COLLECTED /Lilt ample numbers/
b. DILUTED MATERIAL C. RESIDUE
7. WERE THE FOLLOWING LABELING INSTRUCTIONS FOLLOWED? CD YES Q NO flf "NO", check and expitin./
CH TARGET PEST D RATE OF APPLICATION LH REENTRY INTERVAL
C] METHOD OF APPLICATION d CROP. AREA OR OBJECT TREATED Q APPLICATOR CERTIFIED
O DILUTION USED LU CAUTIONARY LABELING £j PREHAHVEST INTERVAL
CH OTHER:
8. CONSEQUENCES OF USE (Lilt an
3. REMARKS
10. DATE OF INVESTIGATION
EPA F.ri. 3540-20 (4.7S)
11. TIME 12. INVESTIGATOR /Slinatunl 13. TITLE
Pesticide Inspection Manual
14-10
January 1989
-------
Chapter Fourteen
Exhibit 14-3
Receipt for Use/Misuse Samples
^,_ U.S. ENVIRONMENTAL PROTECTION AGENCY
ir£t,\
tgigl RECEIPT FOR PESTICIDE
X3^ USE/MISUSE SAMPLES
NAME OF INDIVIDUAL
NAME (Firm, Femer, Homeowner, etc)
SAMPLE NUMBERS
ADDRESS (EPA Keglonel Olliee)
DATE
TITLE
ADDRESS (Street, City, Stele, end ZIP code)
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)
I 1 DUPLICATE SAMI«LES? ' . r 1 DUPLICATE SAMPLES
1 ' REQUESTED AND PROVIDED ' ' NOT REQUESTED
TITLE fOwnar, Opararor.or Agent)
SAMPLES WERE
1 1 PURCHASED f'~1 RECEIVED. NO CHARGE 1 1 BORROWED
AMOUNT PAID FOR SAMPLES
1 1 CASH CI1 VOUCHER 1 1 TO BE BILLED
NAME OF COLLECTOR (Prim or Type) TITLE OF COLLECTC
EPA Form 3540-26(3-77)
R SIGNATURE OF COLLECTOR
Orldntl - OWNER/AGENT COPY
1 -SAMPLE RECORD COPY
2 -REGION COPY
3 -INSPECTOR'S COPY
Pesticide Inspection Manual
14-11
January 1989
-------
Chapter Fourteen Exhibits
Pesticide Inspection Manual 14-12 January 1989
-------
Chapter Fourteen Appendix
APPENDIX TO
CHAPTER FOURTEEN
Use/Follow-up Enforcement Investigations
The following guidance manual describes equipment and methods for sampling
pesticides for enforcement purposes. Procedures are described for the collection
of representative samples of pesticide products for formulation evaluation as well
as methods for collecting environmental samples to be analyzed for suspected
pesticide residues. Also included are brief discussions on container preparation,
packaging, storage, labeling, recordkeeping, quality control, and safety.
Disclaimer
The mention of trade names or commercial products and sources does not
constitute endorsement or recommendation for use by the U.S. Environmental
Protection Agency.
Pesticide Inspection Manual A-i January 1989
-------
Chapter Fourteen Appendix
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF ENFORCEMENT AND COMPLIANCE MONITORING
PESTICIDE SAMPLING PROCEDURES
ADAPTED FROM
NEIC PESTICIDE SAMPLING GUIDE
AUGUST 1985
ROBERT F. SCHNEIDER
NATIONAL ENFORCEMENT INVESTIGATIONS CENTER
DENVER, COLORADO
Pesticide Inspection Manual A-n January 1989
-------
Chapter Fourteen Appendix
CONTENTS
GENERAL CONSIDERATIONS 1
Introduction 1
Inspection 1
Container Preparation 2
Packaging and Storage 2
Sample Identification 3
Recordkeeping 3
Safety 4
FORMULATIONS AND USE DILUTIONS 5
Large-size Sample Containers 5
Dry Materials 5
Apparatus 5
Procedure 6
Comments 7
Liquid Materials 7
Apparatus 7
Procedure 7
Formulations (Retail-sized Units) 8
Use Dilutions 8
Apparatus 8
Procedure 9
SURFACES 10
Apparatus 10
Procedure 11
Comments 12
WATER 13
Surface Water 13
Apparatus 13
Procedure 14
Surface Slicks 15
Apparatus 15
Procedure 15
Comment 16
Tap or Well Water 16
Apparatus 16
Procedure 17
Comment 17
SOIL 18
Surface Soils 18
Apparatus 18
Pesticide Inspection Manual A-iii January 1989
-------
Chapter Fourteen Appendix
Procedure 19
Comment 19
Sediment 19
Apparatus 20
Procedure 20
VEGETATION 21
Apparatus 21
Procedure 22
Comment 22
Agricultural Commodities 22
Specific Procedures 22
ANIMALS 28
Apparatus 28
Procedure 29
Comment 29
AIR 30
Drift or Overspray Monitoring 30
Apparatus 30
Procedure 32
Comment 33
Pesticide Vapor Measurement 34
Apparatus 34
Procedure 35
Comment 35
NOTES 37
Pesticide Inspection Manual A-iv January 1989
-------
Chapter Fourteen Appendix
FIGURES
1. Grain Sampler and Disposable Plastic Tube 5
2. Vacuum Pump Syphon Device 6
3. Swab of Template Area 11
4. Hand-Dipped Sampling Jar 13
5. Weighted Water Bottle Sampler 14
6. Sampling With a Saturation Pad 15
7. Vacuum Pump Syphon Device 16
8. C-18 Extraction Column 16
9. Soil Sampling With a Spatula 19
lO.Phleger Corer 21
ll.EkmanGrab 21
12. Vegetation Sampling Gear 22
13. Animal Sampling Gear 29
14. Sling Psychrometer 32
15. Wind Meter 32
16. Droplet Indicator Paper 33
17. PUF Column 34
18. Constant-Flow Vacuum Pump With PUF Column 34
Pesticide Inspection Manual A-v January 1989
-------
Chapter Fourteen Appendix
Pesticide Inspection Manual A-vi January 1989
-------
Chapter Fourteen Appendix
GENERAL CONSIDERATIONS
INTRODUCTION
This is an adaption from the third edition of the National Enforcement
Investigations Center's (NEIC) Pesticide Sampling Guide. Procedures in this
edition are presented in the format established in earlier editions published by
NEIC in 1975 and 1981. Each chapter describes appropriate sampling methods,
lists needed apparatus and then presents a step-by-step procedure for sampling.
Procedures described are based on current sampling practices by Federal and State
inspectors involved in agricultural or structural pesticide investigations.
The methods represent state-of-the-art techniques; however, sampling
technology and pesticide use patterns are revised constantly so the user of this
guide is encouraged to suggest and forward changes or additions to:
John Ellison
EPA - National Enforcement
Investigations Center
Denver Federal Center
Box 25227
Denver, Colorado 80225
(303)236-5139
FTS 776-5139
Prior to sampling, several factors must be considered by the pesticide inspector.
Foremost is determining if sampling is necessary to document a suspected violation
of Federal or State laws. Laboratory analyses can be time consuming and costly. If
analyses are not needed to document a potential violation, samples should not be
collected.
Typically, samples fall into two categories: Those related to product quality and
those associated with use/misuse investigations. Pesticide product samples usually
include formulated materials from businesses that manufacture, formulate, or
process pesticides (procedures) and those from businesses that wholesale or retail
pesticides (dealers); however products may also be collected at the user level.
Tank-mix or use-dilution samples are usually collected in connection with
use/misuse investigations. Use/misuse investigations will also include usually
trace or low-residue environmental samples such as soil, vegetation, water, etc.
Inspection
Once the decision has been made to collect a pesticide or its suspected residue,
the inspector must determine how to collect a representative sample, how many
samples to collect, how to prepare the sample properly, and how to package and
preserve it for shipment to the laboratory. Although these issues are discussed in
Pesticide Inspection Manual A-l January 1989
-------
Chapter Fourteen Appendix
each of the procedures presented in this manual, general considerations of
container preparation, packaging and storage, labeling, and recordkeeping are
repeated here for emphasis. In the case of unique or new situations not addressed
in this manual, the analytical laboratory should be consulted to assure adequacy of
sampling procedures.
Container Preparation
Residue samples should not be placed in contact with any plastic material
except Teflon. Organic materials, such as plasticizer, can leach from rubber or
plastic into samples causing contamination, or pesticides can absorb into or adsorb
onto rubber and plastics. To avoid preparation problems, samples must be
collected with clean tools (preferably of glass or stainless steel) and placed into
clean glass jars or acetone-washed aluminum foil. Never place samples directly
into plastic bags or plastic bottles. Bottle caps or jar lids must be lined with foil or
teflon. Formulation samples should be handled in similar fashion except that
plastic tubing may be used for sampling and polyethylene lined caps (PolyseaP)
may be used as sample container closures.
Containers (including lids) to be used for residue samples need to be
precleaned by washing with soap and water, followed by rinsing with acetone. The
containers and lids should be allowed to dry thoroughly prior to closure and use.
Formulation and use-dilutions may be placed in new, previously unused containers;
special cleaning procedures are not necessary.
Packaging and Storage
Separate containers should be used for each sample unless composite sampling
is preplanned by the inspector and chemist. After samples are placed into clean
containers, they are identified and officially in plastic bags to comply with custody
procedures.
Residue and use-dilution samples require chilling or freezing to prevent
degradation en route to the analytical laboratory. If necessary, inspectors should
discuss specific preservation requirements for such samples with the laboratory.
Generally, an ice or picnic-type chest with crushed ice is satisfactory to maintain
aqueous based samples below 40° F. A similar-type chest with heavy paper-
wrapped dry ice is suitable to hold temperatures below 10° F for soil, vegetation,
surface and air samples. For safety, never place dry ice in direct contact with glass
or in air-tight containers.
Sample shipping time to the laboratory should be minimized. Preferably
personal delivery or an overnight package service should be used.
R Teflon is a registered trademark; hereinafter shown with R.
Pesticide Inspection Manual A-2 January 1989
-------
Chapter Fourteen Appendix
Sample Identification
Identification labels or seals attached to samples may vary in format but all must
have at least the following information: Sample number, date, contents, and
collector's name or initials. This minimal information should be supplemented by
detailed field notebook information about each sample.
Recordkeeping
Bound field notebooks are normally used to record detailed information about
each pesticide enforcement sample. The recordkeeping format varies for
formulation, use-dilution and residue samples but, at minimum, the following is
required:
o Sample Site Identification
- general location
- specific location
o Date and Time Period of Sampling
o Sample Description
- container contents (specific material collected)
- name of pesticide or residue suspected for which analysis is needed
- reason for collection
- quantity (volume, number, weight)
- identity of related samples (formulation and related residue samples)
o Sampling Method
- composite or grab
- instruments, devices, and tools used
- area, depth, and related facts
- purge time and volume (well water)
- precleaning of equipment and cleaning between uses
o Storage and Shipping
- container type and precleaning
- packaging routine
- preservation
- transport method (date and time)
o Other Documentation
- maps
- field record sheets
- custody and document control records
- books and records
- photographs
Pesticide Inspection Manual A-3 January 1989
-------
Chapter Fourteen Appendix
- statements or affidavits
- technical and professional remarks
Safety
It is the responsibility of each inspector to protect himself/herself and others
during pesticide handling and sampling activities associated with an investigation,
particularly when sampling formulations and use-dilutions. Each sampling
procedure described in this manual poses some degree of health and safety risk. To
minimize this risk, appropriate protective clothing and safety equipment must be
used by inspectors. Protective gear must be adequate to prevent accidental
exposure to pesticides through eyes, nose, mouth, and skin. The inspector should
refer to the precautions described on the label of each pesticide product being
handled and sampled, in addition to being fully acquainted with safety and health
policies of their governing Agency. For a detail discussion on safety, inspectors are
encouraged to refer Chapter 21 of this manual.
Pesticide Inspection Manual A-4 January 1989
-------
Chapter Fourteen
Appendix
FORMULATIONS AND USE DILUTIONS
This section describes the apparatus and procedures for subsampling larger
containers of formulation pesticides at a producer, marketplace, or user facility, as
well as diluted pesticides from a user.
LARGE-SIZE SAMPLE CONTAINERS
Dry Materials
Subsampling of larger containers is usually recommended because: (1) the cost
of larger amounts is frequently prohibitive, (2) larger size units are difficult to
handle and costly to ship, and (3) the increased amount of material left over after
testing may create disposal problems. Therefore, dry products in containers in
excess of 20 pounds are usually subsampled at the inspection site. Some products,
such as retail size lawn products, should be submitted in entirety to the laboratory
for subsampling and analysis. Discretion to be used if there is reason to deviate
from these guidelines.
Apparatus
1. Acetone-washed grain sampler or previously unused, disposable-type plastic
tube (Fisher Grain Sampler, Stock No. 14-208, Fisher Scientific, 711 Forbes
Avenue, Pittsburgh, Pennsylvania 15219), or a disposable plastic golf ball tube
(available from sporting goods stores).
Figure 1. Grain Sampler and Disposable Plastic Tube
Pesticide Inspection Manual
A-5
January 1989
-------
Chapter Fourteen
Appendix
2. Widemouth glass pint or quart jars with teflon-lined lids.
3. Data sheets and identification tags.
4. Labeled shipping container.
Procedure
1. Lay the bag of pesticide on its side.
2. Insert closed metal grain sampler or plastic tube diagonally into the bag
through the seam at the top corner.
3. Push the closed sampler or tube to the opposite bottom corner of the bag. By
opening and closing the sampler or filling the tube, collected a representative
sample of the material from different sections of the bag.
4. Carefully withdraw the sampler or tube containing sampled material.
5. Transfer dry material into glass jar; label and prepare for shipment to the
laboratory. Collect at least 4 ounces from each of two units for low concentration
(less than 10% active ingredient) products. Collect at least 1 ounce from each of
two units for wettable powders or other concentrates. Duplicate samples should be
collected from each container if non-uniformity is noted.
6. Samples from the same container may be composited. Samples from
different units are to be placed in separate containers.
Figure 2. Vacuum Pump Syphon Device
Pesticide Inspection Manual
A-6
January 1989
-------
Chapter Fourteen Appendix
Comments
Avoid cross-contaminating samples by cleaning or replacing sampling tools
between each sampling use. If a plastic tube is used to collect the sample, it should
be destroyed by cutting and disposing of in a satisfactory manner. Because the
grain sampler is a reusable tool, it should be washed with water and acetone-rinsed
before using for additional sampling.
If the dealer, producer, or agent requests a duplicate sample, it is collected,
identified, and officially sealed in the same manner as described above.
Liquid Materials
Subsampling at the distributor, retail, or user level is recommended for liquids
in containers in excess of 1 gallon. Smaller volumes should be taken as an entire
unit. Various types of siphon devises or chemically cleaned glass tubes (glass thief)
are typically used to collect liquids from containers larger than 1 gallon.
Apparatus
1. Acetone-washed glass tubing or a siphon device with disposable tygon hose
(Hand-operated vacuum pump, Stock No. TR-6513-00, Cole-Parmer Instrument
Company, 7425 N. Oak Park Ave., Chicago, Illinois 60648)
2. 40 mL Volatile Organic Analysis (VGA) or pint glass bottle with teflon-lined
lid
3. Identification labels, plastic bags, and official seals
4. Labeled shipping container with appropriate packing
Procedure
1. Thoroughly agitate liquid material by rolling or shaking can, barrel or drum
before sampling.
2. Insert siphon hose or glass tubing (thief) through open pour hole in bulk
container.
3. Collect a composite sample from three depths; near bottom, middle, and at
top of liquid level. If sediment, layering, or phase separation is observed, collect a
duplicate sample.
4. Collect at least 1 ounce from concentrated products and 4 ounces from
diluted products where active ingredients are less than 10%.
Pesticide Inspection Manual A-7 January 1989
-------
Chapter Fourteen Appendix
5. After transfer of the liquid sample into glass sample container, label, official
seal, and package for shipment.
6. Properly dispose of hose. Reclean contaminated sampling equipment with
acetone and rinse with clean water and acetone before collecting additional
samples.
FORMULATIONS (RETAIL-SIZED UNITS)
Container sizes in this category are usually 1 gallon or less for liquids and 20
pounds or less for solid materials. An entire container (or group of containers) is
usually randomly selected from a lot is purchased from the producer, dealer or
user. Further details regarding sample selection and related documentation are
presented in Chapter 12 of this manual.
Collect enough retail units to equal at least 8 ounces for concentrated products
with more than 1% active ingredients. Collect at least 16 ounces for products with
single active ingredients of 1% or less. At least four pressurized containers should
be collected to provide an adequate sample size for the chemical analyses of these
types of products.
Use Dilutions
Usually this type of pesticide material will be in liquid form (water or
occasionally oil). Sampling and analysis of material from a service container or
application tank will seldom document that materials were mixed under strength to
the probability of active ingredient decomposition and/or phase separation;
however, analytical results can be used for qualitative purpose and occasionally for
evidence of overmixing. Documentation of proper mixing is more effectively
obtained through interview and observation of mixing techniques. A formulation
sample should always be collected and analyzed with any use-dilution to provide
evidence that over-formulation or identification of a misused pesticide is not a
problem associated with the product that was used.
Apparatus
1. Siphon device with disposable tubing (Stock No. TR-6513-00, Cole-Parmer
Instrument Company, 7425 N. Oak Park Ave., Chicago, Illinois 60648).
2. Glass pint or quart bottle with teflon-lined lid.
3. Data sheets and identification tags.
4. Labeled shipping container with ice and appropriate packing to meet DOT
regulations.
Pesticide Inspection Manual A-8 January 1989
-------
Chapter Fourteen Appendix
Procedure
1. Thoroughly agitate liquid in service container or tank (as appropriate,
operate mechanical agitator to assure adequate mixing).
2. For aerial application sampling, collect use-dilution samples from spray
boom nozzles, ideally collecting the sample after the completion of the application.
Loosen boom nozzle or stopcock drain and blend the pesticide mix into a glass
sample container. If possible, remove at least 1 quart of use-dilution in a larger
container, such as a jar or beaker, mix well and pour off 4 ounces for the official
sample. Collect in duplicate.
3. For service containers or tanks, insert siphon tubing through fill opening or
collect a well-mixed sample from the drain system. In some cases, a sample from
service container can be collected by directing nozzle spray into a collection
container. If possible, collect a composite sample from three depths; near bottom,
middle, and at top of the liquid level or from different drain points on the rig. Also,
if possible, collect at least 1 quart of pesticide mixture, mix well and pour off 4
ounces for the official sample and return the remainder to the tank. Collect in
duplicate.
4. After transfer of the liquid sample to a glass sample container, label, official
seal, and package for shipment. Refrigerate to the extent possible.
5. Properly dispose of used tubing and reclean other contaminated sampling
equipment with water and acetone before collecting additional samples.
6. Consult the laboratory if new or unique situations should arise, or if
exceptions to the above guidelines are necessary.
Pesticide Inspection Manual A-9 January 1989
-------
Chapter Fourteen Appendix
SURFACES
To determine the extent of application coverage or contamination of surfaces, a
technique known as wipe or swab sampling is used.
Nonporous areas, such as finished wood, tiles, linoleum, metal, and glass, are
measured and swabbed with an absorbent paper wetted with an appropriate solvent
to remove the compounds of interest from the surface. The absorbent paper is
packaged and transferred to the laboratory, extracted with solvent and analyzed by
standard analytical techniques, such as gas and/or liquid chromatography.
Concentrations are normally reported either as weight (usually micrograms) per
unit area or weight per swab. Reported analytical results are usually considered
semi-quantitative, at best, due to the difficulty of achieving 100% removal from the
surfaces.
Porous areas, such as cement, untreated wood, carpet, or drapes, can be
sampled with the same technique to provide qualitative identification of pesticide
application or contamination.
Inspectors should wear protective disposable gloves, either nitrile, vinyl, or
latex. The solvents, iso-octane and isopropanol, are relatively non toxic; however,
care should be taken to minimize respiratory and skin exposure. Both solvents are
flammable; thus, care should be taken when using these solvents around pilot
lights, lit burners, contact switches, cigarettes, and other sources of ignition.
Absorbent pads (swabs) should not be handled with bare hands, but only with clean
gloves or clean forceps. Chlordane and heptachlor are suspected carcinogens and
samples or surfaces suspected to contain these chemicals should be handled
accordingly.
The technique described here and additional information on storage,
extraction, and related analytical methods can be found in the NEIC draft
publication Sampling and Analysis of Surfaces for Pesticides and PCBs.1
Apparatus
1. Absorbent pad, 10 cm x 10 cm [Stock No. 7588 - Alltech Associates,
Waukegan Dr., Deerfield, Illinois 60015 (available in boxes of 100)].
2. Isopropanol (pesticide or reagent grade). Consult laboratory for other
suitable solvents, if necessary.
3. Screwcap 40 ml Volatile Organic Analysis (VOA)2 vials with TeflonR-lined
septum.
4. Disposable gloves of latex (Markson 17118), nitrile (Fisher 11 394 23A) or
vinyl (Bard-Parker H8294-002510).
Pesticide Inspection Manual A-10 January 1989
-------
Chapter Fourteen
Appendix
Figure 3. Swab of Template Area
5. Eye-dropper bottle or other suitable container filled with appropriate
solvent (isopropanol, iso-octane, etc.).
6. Disposable templates with 10 x 10-cm-square (4" x 4") opening cut from
cardboard, or equivalent.
7. Plastic bag for used gloves and other onsite disposables.
8. Data sheets, labels, and shipping containers.
Procedure
1. Fold a 10-cm-square absorbent pad into a 2.5-cm-square.
2. Grasp the two inner pockets formed in folded pad with freshly gloved fingers
or forceps.
3. Place template on surface to delineate area to be sampled.
4. Wet both external surfaces of pad with isopropanol or other appropriate
solvent (do not use solvent when surface to be sampled is visibly wet; simply blot
liquid within measured area).
5. Blot 10-cm-square area horizontally with one side of the wet swab and then
vertically with the other. Cover complete area at least twice.
Pesticide Inspection Manual
A-ll
January 1989
-------
Chapter Fourteen Appendix
6. Carefully roll the sample swab into a cylinder with exposed, wet areas inside.
7. Insert rolled swab into VGA vial and cap with teflon-lined lid.
8. Seal, label with appropriate identification, and prepare for transport to
laboratory.
9. Place used template and gloves in plastic bag and dispose of properly.
Comments
Dirt or finishes, such as wax, paint, or lacquer, can give rise to analytical
interferences. Blotting versus wiping or rubbing is recommended to minimize
inadvertent collection of debris and to maximize uptake of the pesticide. If
possible, a background sample should be collected from an untreated or "clean"
area of the same surface composition as the area of interest. Because of the non-
uniformity of surface contamination, side-by-side samples should be considered
separate samples and not duplicates.
Pesticide Inspection Manual A-12 January 1989
-------
Chapter Fourteen Appendix
WATER
SURFACE WATER
A common method for collecting water from ponds, lakes, and streams is by
dipping the sample bottle to obtain water at or near the surface. This technique is
effective because many pesticides, especially oil-based, remain on the water
surface. If physical conditions, such as inaccessible shoreline, preclude the dip
method or, if subsurface water samples are needed, alternate methods are available
using a sampling jar attached to a telescoping pole, hand pumps, or weighted water
samplers. Consequently, equipment costs vary from less than $ 1 for a sample jar to
$250 for commercial water-sampling devices.
Apparatus
1. Widemouth 1-gallon glass jar with teflon-lined lid for use as sampling device
and/or sample container.
2. Hand pump or weighted water sampler (Van Dorn, Kemmerer, APHA
sampler) for subsurface sampling or situations where bottle or jar cannot be
dipped.
3. Ice for chilling samples.
4. Data sheets, identification tags, and shipping container.
Figure 4. Hand-dipped Sampling Jar
Pesticide Inspection Manual A-13 January 1989
-------
Chapter Fourteen
Appendix
Figure 5. Weighted Water Bottle
Sampler
Procedure
1. Dip, pump, or otherwise collect a minimum of a gallon (ca 4 L) of water into
a clean glass jar (never use plastic bottles). Collect at least one duplicate sample
for quality control analysis.
2. Avoid collection of bottom sediment; guard against roiling sediment when
collecting a subsurface water sample.
3. Each sample container should represent a single sample location. Submit an
unused sample jar and lid to the chemist as a blank for quality control analysis.
4. Label, officially seal, and pack glass jars to comply with shipping and custody
requirements. Water samples should be kept on ice and protected from direct
sunlight. Consult chemist for special preservation and holding time requirements,
if necessary.
Pesticide Inspection Manual
A-14
January 1989
-------
Chapter Fourteen Appendix
Figure 6. Sampling With a Saturation Pad
SURFACE SLICKS
If water depth precludes dipping a bottle to collect a sample from a visible slick
on the surface of the water, the preferred method is the saturation pad technique.
Apparatus
1. Saturation (absorbent) pad, 10-cm-square [Stock No. 7588 - Alltech
Associates, Waukegan Dr., Deerfield, Illinois 60015 (available in boxes of 100)].
Extract with methanol at least 10 cycles on Soxhlet apparatus when using for
organophosphate sampling.
2. Precleaned forceps and disposable gloves of latex, nitrile, or vinyl.
3. Screwcap 40 mL VOA vials3 with teflon-lined septum.
4. Data sheets, labels, official seals, and shipping container.
Procedure
1. Grasp the saturation pad firmly with clean forceps and gently swab over the
slick on the water surface. Collect a duplicate sample from the same site and
submit it to the chemist for quality control analysis.
2. Roll the pad into a cylinder with swab surface inside.
Pesticide Inspection Manual A-15 January 1989
-------
Chapter Fourteen
Appendix
.:---. ...;:•.'.: . :
Figure 7. Vacuum Pump
Syphon Device
FigureS. C-18 Extraction
Column
3. Insert rolled pad into a VOA vial and cap. Insert a second unused pad in
another clean VOA vial and submit to the chemist as a blank for quality control
analysis.
4. Label, officially seal, and pack vials containing swab pads for shipment to
laboratory.
5. Reclean forceps with acetone and rinse with clean water. Replace disposable
gloves between collection of each surface-slick sample.
Comment
Analytical results are reported on a weight per pad basis. It may be appropriate
to composite several swab pads for a single sample. Do not redip a saturation pad
or use both sides to collect a surface slick, as such a procedure may result in
removing collected material from the pad.
TAP OR WELL WATER
Tap or well-water samples are often collected directly into a sample bottle. If
numerous samples of water are needed, volume, weight, and glassware may become
of concern to the inspector. An alternate method is described belowfor conserving
space and weight when large volumes of clean water (low amounts of particulates)
are required for an investigation.
Pesticide Inspection Manual
A-16
January 1989
-------
Chapter Fourteen Appendix
Apparatus
1. Disposable C-18 extraction column (Bond ElutR columns, Analytichem
International, 24210 Frampton Ave., Harbor City, California 90710 or equivalent)
2. Flexible tubing.
3. Hand-operated vacuum pump (Stock No. TR-6513-00, Cole-Parmer
Instrument Company, 7425 N. Oak Park Ave., Chicago, Illinois 60648).
4. 1,000 mL calibrated beaker or graduated cylinder.
5. 1,000 mL vacuum flask with stopper.
6. Acetone-washed aluminum foil.
7. Plastic bag.
8. Data sheets, labels, official seals, and shipping container.
Procedure
1. Insert luer fitting of the C-18 extraction column into the flexible tubing and
connect the other end to the vacuum flask and pump assembly.
2. Submerge the tip of extraction column in a clean, calibrated beaker or
graduated cylinder filled with the tap or well water to be sampled.
3. Filter 1,000 mL (accurately measured) of the water sample through the C-18
extraction column; discard the filtrate. Collect a duplicate sample from at least
one site and submit it to the chemist for quality control analysis.
4. Wrap the used extraction column in aluminum foil, place in a properly
labeled plastic bag, officially seal, and pack for shipment to laboratory. Also
submit an unused column to the chemist as a blank sample for quality control
purposes.
5. Acetone-rinse the beaker or graduated cylinder before collecting additional
tap or well water samples.
Comment
The laboratory should be consulted for technical assistance prior to conducting
this type of sampling and to obtain the proper cartridges.
This procedure is limited by the porosity of the C-18 sorbent in the column. If
water has large amounts of particulates, the column can clog. Prefiltering could
Pesticide Inspection Manual A-17 January 1989
-------
Chapter Fourteen Appendix
solve clogging, but may preclude collecting a representative sample; therefore, if
clogging occurs, collect water directly in an appropriately labeled glass container.
Pesticide Inspection Manual A-18 January 1989
-------
Chapter Fourteen Appendix
SOIL
SURFACE SOILS
For pesticide enforcement investigations, soil sampling must be designed to
detect overspray, drift, spillage, or some other type of misapplication. Because
these situations often result in pesticide residues on the soil surface, the procedure
described below is for collecting soil within the top inch of the surface. This
procedure can be used for collecting deeper soil following appropriate excavation
to the desired depth; however, care must be taken to avoid contamination of deeper
soils by high-level pesticide residues in surface deposits. Zero contamination
coring tools, such as the JMC sampler (available from A&L Mid West
Laboratories, Omaha, NE 68144), are available and should be employed if core
samples are going to be taken on a regular basis.
Apparatus
1. Stainless steal spatula, spoon, or scoop.
2. Acetone (pesticide grade).
3. Acetone-washed aluminum foil or glass jar with teflon-lined lid.
4. Shallow, steel pan or pail.
5. Plastic bag.
6. Data sheets, labels, official seals, and shipping container with dry ice.
Figure 9. Soil Sampling with a Spatula
Pesticide Inspection Manual A-19 January 1989
-------
Chapter Fourteen Appendix
Procedure
1. Scrape and/or scoop with the spatula approximately a pint of top soil (to a
depth of no more than 1 inch) from the sample site. Minimize collection of rocks,
sticks, leaves, and debris.
2. Directly place soil into labeled glass jar or onto aluminum foil lining a
shallow pan (pan supports foil to prevent tearing during soil collection).
3. Close jar or wrap each individual sample in foil and place in a separate
plastic bag.
4. Label samples with appropriate identification, officially seal and place them
in the shipping container.
5. Reclean sampling tools by acetone and rinsing with clean water and acetone
before collecting additional soil samples.
Comment
Judgment will be necessary so as to minimize the number of soil samples
collected and to ensure that samples are taken only in situations where
environmental or human health risk is probable. In agricultural situations, soil
samples from the treated field, fence lines, or turnrows often produce highest
pesticide concentrations, and may thus serve as positive controls, if appropriate.
Soil acidity or alkalinity will deteriorate aluminum foil over long storage
periods; therefore, when sample storage is to exceed 1 week, soil samples should be
placed in glass containers fitted with teflon-lined lids and kept frozen.
SEDIMENT
Pesticide residues may accumulate in the bottom sediment of lakes and streams.
Under certain physical and chemical conditions, these residues can be rapidly
released into the water causing fish kills or other contamination problems. Thus, it
may be necessary to conduct sediment sampling to document the pesticide source
and/or hazard.
Commercially available devices for sediment sampling include Emery
bacteriological sampler ($200), Phleger corer ($350), mud snapper ($150),
Petersent Grab ($300), and Ekman Grab ($175). These devices often require
extensive cleaning between sampling to alleviate cross-contamination, so a simple
and inexpensive ($3) technique is recommended in this section: a disposable core
tube.
Pesticide Inspection Manual A-20 January 1989
-------
Chapter Fourteen
Appendix
Figure 10. Phleger Corer
Figure 11. Ekman Grab
Apparatus
1. Disposable type core tube or commercially equivalent device.
2. Wash pan (precleaned with acetone).
3. Widemouth glass jar with teflon-lined lid.
4. Forceps or large tweezers.
5. Data sheets, labels, official seals, and shipping container with crushed ice.
Procedure
1. Carefully lower disposable core tube or other sampling device through water
into sediment (minimize roiling the sediment).
2. Retrieve approximately 1 pint of sediment.
3. Directly transfer sediment into a clean glass sample jar or a clean pan.
4. Remove rocks, leaves, and other debris from sediment with clean forceps
before transferring to the widemouth glass jar.
5. Label and officially seal samples, and store in the shipping container with
crushed ice for transport to laboratory.
6. Properly dispose of core tube. Rinse pan with clean water and acetone
before reusing for collection of additional sediment samples.
Pesticide Inspection Manual
A-21
January 1989
-------
Chapter Fourteen
Appendix
VEGETATION
Pesticide drift, overspray, or other misapplication incidents are often
documented by collecting and analyzing plants for residues. The sampling
technique described below is applicable for most non-crop or off-field vegetation
where drift or overspray is to be documented. For documenting acceptable
pesticide tolerance levels in feed and foodstuffs, refer to the sampling method
described in the second section of this chapter. Cost of supplies for plant sampling
usually is less than $25.
Apparatus
1. Shovel and clippers.
2. Acetone-washed aluminum foil.
3. Disposable gloves of latex, vinyl, or nitrile.
4. Plastic bags or glass jars.
5. Data sheets, labels, official seals, and shipping container with dry ice.
;
Figure 12. Vegetation Sampling Gear
Pesticide Inspection Manual
A-22
January 1989
-------
Chapter Fourteen Appendix
Procedure
1. Collect approximately 1 pound (1 quart) of affected vegetation. For small
plants where systemic pesticide absorption is suspected, uproot entire plant;
otherwise remove plant parts such as leaves. If possible, collect a directly sprayed
plant (on-field) for use as a positive control.
2. Cover work surfaces with clean aluminum foil and, wearing disposable
gloves, prepare samples by removing soil and cutting into suitable length size for
wrapping.
3. Wrap sample in foil; usually one type of vegetation or crop per sample.
4. Place foil-wrapped sample in bag or box, label, and officially seal.
5. Place samples in shipping container and freeze.
6. Properly dispose of gloves and then clean shovel and/or clippers and with
clean water and acetone before continuing to sample other vegetation.
Comment
Plants are often very perishable and must be frozen as soon as possible for
transport to the laboratory. It may be necessary to air-dry damp vegetation before
wrapping or to freeze wet samples to prevent decomposition during shipment. If
dry ice is shipped with samples, it should be wrapped securely in heavy paper (for
safety, never pack dry ice in glass, metal, or air-tight containers).
Agricultural Commodities
This section contains procedures for collecting representative plant parts
normally consumed by humans and livestock. These sampling and packing
instructions for agricultural commodities are modified from Guidelines for
Collecting Field Samples. U.S. Environmental Protection Agency, Office of
Pesticide Programs, Washington, D.C., March 1979. For all commodities listed
below, the sample should be placed in the aluminum foil, glass jar, or other primary
container and protected from direct contact with the dry ice by using a paper bag or
other suitable insulating material. The paper bag may be used to inscribe or attach
the sample identification information.
Specific Procedures
Artichokes Collect about 1 pound of fruit (5 to 10 buds). Chill, if
possible.
Packing: Aluminum foil, paper bag, shipping case.
Pesticide Inspection Manual A-23 January 1989
-------
Chapter Fourteen
Appendix
Asparagus
Beans (for
shelling, including
peas, lima beans,
dried beans, etc.,
not soybeans)
Beans (snap, also
edible, podded
peas)
Beets, red
Berries (all,
including
strawberries)
Broccoli
Brussels Sprouts
Cabbage
Cantaloupe
Carrots
Cauliflower
Celery
Collect about 1 pound of stalks cut at ground level (15 to
25 stalks). Chill.
Packing: Aluminum foil, paper bag, shipping case.
Cut enough plants to yield 1 quart of shelled beans. Air
dry; shell beans. Discard all plant material except beans.
Packing: Place in clean quart jar can; shipping case.
Collect 1 quart of the vegetable. Chill.
Packing: Aluminum foil, paper bag, shipping case.
Collect four beets. Remove and discard tops.
Packing: Aluminum foil, paper bag, shipping case.
Collect 1 quart of ripe berries. Carry a flat of new 1-quart
ice cream cartons and place berries directly
strawberries)into these cartons as they are picked.
Freeze samples. Mark "Perishable."
Packing: 1-quart ice cream cartons, shipping case.
Collect about 1 pound of spears (15 to 20). Chill samples.
Mark "Perishable."
Packing: Aluminum foil, paper bag, shipping case.
Collect about 1 pound of sprouts (15 to 25 sprouts).
Packing: Aluminum foil, paper bag, shipping case.
Collect two heads.
Packing: Aluminum foil, paper bag, shipping case.
See Melons.
Collect one bunch of carrots (6 to 10). Remove and
discard tops.
Packing: Aluminum foil, paper bag, shipping case.
See Cabbage.
Collect one bunch (6 to 10 stalks). Keep samples chilled.
Mark "Perishable."
Packing: Aluminum foil, paper bag, shipping case.
Pesticide Inspection Manual
A-24
January 1989
-------
Chapter Fourteen
Appendix
Corn (field and
sweet)
Cotton
Cucumber
Eggplant
Forage
Fruit (including
citrus, pomes,
stone fruit)
Garlic
Grains
small (including
barley, buckwheat,
millet, flax, rice,
rye, wheat, wild
rice, etc.)
Collect 1 quart of kernels by removing 8 to 10 lengthwise
rows of kernels per ear. Collect three stalks; air dry; cut
stalks into 6- to 10-inch lengths; thoroughly mix and
retain about 1 pound as the sample.
Packing: Corn grain - clean quart jar or can. Sweet can
kernels must be kept frozen or chilled and should be
marked "Perishable." Corn stalks - aluminum foil, paper
bag, shipping case.
Sample three to five mature cotton plants. Where
average plant height for the site does not exceed 3 feet,
take entire plant. Where average height is greater than 3
feet, cut branches from the main stalk, uniformly
sampling the top, middle and bottom one-third of each
plant.
Packing: Remove all open bolls; wrap with aluminum foil
and place in a paper bag, then in a shipping case. Cut
plants or plant parts into 6- to 10-inch lengths, retaining
the green bolls. Air dry and mix. Wrap about 1 pound of
this composite sample with aluminum foil and place in a
paper bag, then in a shipping case.
Gather two or three mature cucumbers. Chill, if possible.
Packing: Aluminum foil, paper bag, shipping case.
Collect one or two eggplants.
Packing: Aluminum foil, paper bag, shipping case. Use
packing material to prevent damage during shipment.
Sample when available. See Hay.
For small fruit such as cherries, collect 1 quart of fruit.
For larger fruit, collect two or three fruit. Keep chilled.
Packing: Pack fruit gently and securely in suitable
container to prevent injury during shipment. Mark
shipping container with "Perishable" label.
Collect six to eight bulbs. Remove and discard tops.
Packing: Aluminum foil, paper bag, shipping case.
Cut several handfuls of plants. Cut heads from straw.
Packing: Heads should be packed separately from straw.
Composite about 1 pound of straw for sample.
Wrapping: Aluminum foil, paper bags, shipping cases.
Pesticide Inspection Manual
A-25
January 1989
-------
Chapter Fourteen
Appendix
Grapes
Hay
Leafy vegetables
(including chicory,
collards, endive,
escarole, field
cress, kale, leaf
lettuce, mustard
greens, parsley,
spinach, Swiss
chard, watercress,
etc.)
Lettuce, head
Melons (including
cantaloupe,
honeydew,
watermelon, etc.)
Nuts and seeds
(except peanuts)
Okra
Onion
Peas
Peas, edible
podded (snowpeas,
Chinese peas)
Collect a 1-pound bunch. Keep chilled.
Packing: Aluminum foil; pack securely in shipping
container (not too tightly). Mark shipping container with
a "Perishable" label.
Sample near the end of growing season, but before the
last cutting. Cut small handfuls of plants. If vegetation is
sparse, take forage within several square yards. Air dry,
mix thoroughly, and retain about 1 pound for sample.
Packing: Aluminum foil, paper bag, shipping case.
For small plants, gather leaves from three plants. For
large plants such as collards, gather one plant.
Packing: Aluminum foil, paper bag, shipping case.
See "Cabbage," keep chilled. Mark "Perishable."
Collect one melon. Keep chilled.
Packing: Aluminum foil, shipping cases.
Collect 1 pint of nuts or seeds. Thrash the seed.
Packing: Clean pint jar or can; shipping case.
Collect six to eight okra.
Packing: Aluminum foil, paper bag, box.
Collect two to three mature onions. Remove and discard
tops. Allow onions to dry slightly before packing. Shake
off soil particles.
Packing: Aluminum foil, paper bag, shipping case.
See "Beans" (for shelling).
See "Beans," snap.
Pesticide Inspection Manual
A-26
January 1989
-------
Chapter Fourteen
Appendix
Peanuts
Pepper, bell
(sweet)
Pepper, hot
Peppermint
Potatoes, sweet or
white
Pumpkin
Radishes
Rhubarb
Rutabaga
Scallions (spring
onions)
Silage, corn and
sorghum
Collect enough plants to yield 1 pint of shelled peanuts
and about 1 pound of hulls and vines. Air dry. Shell
peanuts and retain hulls and vines.
Packing: Clean pint jar or metal container for peanuts.
Aluminum foil, paper bag, box for hulls and vines;
shipping case.
Collect two or three peppers.
Packing: Aluminum foil, paper bag, box. Use packing
material to prevent damage. Keep chilled. Mark
shipping case with a "Perishable" label.
Collect 8 to 10 hot peppers.
Packing: Aluminum foil, box. Keep chilled.
Sample as for hay.
Collect two or three. Remove soil by shaking.
Packing: Aluminum foil, paper bag, suitable container.
Chill, if possible.
Gather one pumpkin.
Packing: Aluminum foil, suitable container.
Collect six to eight radishes. Remove and discard tops.
Packing: Aluminum foil, paper bag, box. Chill, if
possible.
Collect six stalks. Chill.
Packing: Aluminum foil, paper bag, shipping case.
Collect three or four rutabaga. Remove tops and discard.
Packing: Aluminum foil, suitable container.
Collect 8 to 10. Shake off as much soil as possible. Keep
chilled. Mark "Perishable."
Packing: Aluminum foil, plastic bag, cloth bag, shipping
case.
Collect three stalks. Cut stalks into 6- to 10-inch lengths.
Thoroughly mix, air dry, and retain 1 pound as sample.
Packing: Aluminum foil, paper bag, shipping case.
Pesticide Inspection Manual
A-27
January 1989
-------
Chapter Fourteen
Appendix
Sorghum, grain
Soybeans
Spearmint
Squash, summer
(yellow, white,
zucchini)
Squash, winter
(acorn, butternut,
hubbard, etc.)
Sugar beets
Tobacco
Tomatoes
Tomatoes, cherry
Turf
Turnips
Collect three plants. Remove heads. Air dry. Cut stalks
into 6- to 10-inch lengths. Thoroughly air dry, mix, and
retain 1 pound as sample.
Packing: Pack heads and stalks separately. Wrapping:
Aluminum foil, paper bag, shipping case.
Cut enough plants to yield 1 pint of shelled beans and
about 1 pound of vines. Air dry; shell beans.
Packing: Vines - aluminum foil, paper bag. Beans-clean
pint jar or can, shipping case.
Sample as for hay.
Summer squash should be harvested when small and
tender. Gather two squash.
Packing: Keep chilled. Aluminum foil, paper bag, box.
Winter squashes should be harvested when mature.
Collect two mature winter squashes.
Packing: Aluminum foil, cases suitable for shipment.
Collect two sugar beets. Remove tops; keep chilled.
Packing: Beets - wrap individually with aluminum foil
and pack in shipping case. Tops - aluminum foil, paper
bag, shipping case.
Collect two or three ripe leaves.
Packing: Aluminum foil, paper bag, box.
Collect two tomatoes. Keep chilled. Mark shipping case
with a "Perishable" label.
Packing: Wrap individually in aluminum foil and pack
carefully in suitable container. (Use packing material to
protect tomatoes.)
Collect 10 to 12 cherry tomatoes. Keep chilled.
Packing: New 1-pint ice cream cartons, suitable shipping
container. Mark "Perishable."
Follow instructions for hay.
Collect four to six turnips. Remove tops and freeze.
Packing: Pack tops and roots separately. For both:
Aluminum foil, paper bag, box.
Pesticide Inspection Manual
A-28
January 1989
-------
Chapter Fourteen
Appendix
ANIMALS
Misapplication, drift, overspray, spillage, and other incidents with pesticides
may result in injury or death to animals. Pesticide residue sampling of tissue,
blood, urine, or related material from humans, livestock, or wildlife should be
performed by a physician, veterinarian, or trained laboratory technician, as
appropriate. Such sampling is beyond the scope of this manual and will not be
addressed. Occasionally, however the pesticide inspector may find dead fish, birds,
bees, or other small animals at or near a potential pesticide misuse site. With
reasonable suspicion that pesticides were the cause of death, the inspector may
need to collect such samples. Sampling costs are minimal (less than $5), but
analysis may often be expensive; thus, judgement is essential before collecting and
shipping animal specimens to the laboratory for pesticide residue analyses.
Apparatus
1. Dipnet, tongs, and knife.
2. Disposable gloves.
3. Acetone-washed aluminum foil.
4. Shallow, flat-bottomed pan.
5. Scalped or sharp knife.
AUMAX
,S INC.
Figure 13. Animal Sampling Gear
Pesticide Inspection Manual A-29
January 1989
-------
Chapter Fourteen Appendix
6. Plastic bag or widemouth glass jar with teflon-lined lid.
7. Data sheets, labels, official seals, and shipping container with dry ice.
Procedure
1. Unless instructed otherwise, collect only dead but undecomposed animals.
2. Preferably collect entire animal but, if impractical, collect at least a pound of
tissue (approximately 1 pint).
3. As appropriate, place the dead animal in an aluminum-lined pan to cut tissue
samples before wrapping. Avoid skin contact with dead and possibly diseased
animals by wearing protective clothing, including face mask and disposable gloves.
4. Place entire animal or tissue in clean glass jar or wrap sample in foil and
place in plastic bag; attach identification tag and officially seal.
5. Immediately freeze samples or place them in shipping container with dry ice
for transport to the laboratory.
6. Wash with clean water and acetone rinse all tools used in collecting and
preparing animal samples; properly dispose of gloves and used aluminum foil.
Comment
Animal deaths may be caused by disease, so caution must be taken to protect the
inspector and others when handling dead animals or tissue during a pesticide
investigation. If a question about health or sample preparation technique exists,
consult a veterinarian or wildlife biologist before proceeding with collecting or
dissecting dead animal specimens.
Pesticide Inspection Manual A-30 January 1989
-------
Chapter Fourteen Appendix
AIR
Sampling air for pesticide residues requires considerable preplanning by the
inspector and laboratory staff. The primary objective that must be considered is of
what value the air sampling and analyses will be in documenting a health misuse or
a specific environmental problem. Once the necessity to collect airborne pesticide
residues has been determined, the next consideration is to select the appropriate
sampling method.
Two mechanical procedures for collecting airborne pesticide residues are
described. One method is designed to collect pesticide droplets (aerosols), the
other for vapor (volatiles). Equipment and supply costs for the two methods range
from less than $10 (droplet sampling) to nearly $1,000 (vapor sampling).
Measurements of temperature and relative humidity are an essential part of
exterior air monitoring. These parameters provide atmospheric information often
linked to vapor or droplet pesticide drift problems. These measurements are also
needed to provide for the interconversion of weight per unit volume (e.g. ug/L) to
volume/volume percent (ppm). In the agricultural or outdoor setting, wind
direction and speed, if known or can be determined, must be recorded also.
Inexpensive devices suitable for these measurements are a pocket sling
psychrometer for temperature and humidity ($35) and a pocket wind meter ($10).
A manufacturing source is Weather Measure, P.O. Box 41039, Sacramento,
California 85841. Respectively, the psychrometer and wind meter are model
number 5220 and 2520 in the 1985 Weather Measure catalog.
DRIFT OR OVERSPRAY MONITORING
The simplest method for detecting pesticide deposits (droplets) from overspray
or drift during a planned application is through the use of spray droplet papers.
Two types of commercially available paper sheets are available: One is a rigid
paper sheet coated with a yellow surface that stains dark blue with water droplets.
The other is also rigid, but coated with a white surface that stains black with oil
droplets. Because pesticide formulations are usually diluted in water or oil, these
paper sheets are adequate for quickly detecting spray patterns and droplet
deposits. To increase monitoring effectiveness, it is recommended that the water
and oil sensitive sheets be stapled side-by-side on posterboard along with a
chemically-clean, 10-mm-square saturation pad. This arrangement will enable the
inspector to visibly detect oil- or water-based pesticide droplets that have impinged
on the papers, as well as providing a residue sample on the clean saturation pad for
chemical analysis.
Apparatus
1. Water-sensitive paper, 76 mm x 52 mm [Stock No. 20301-2, Spray Systems
Co., North Avenue at Schmale Rd., Wheaton, Illinois 60187 (available in package
of 50 cards)].
Pesticide Inspection Manual A-31 January 1989
-------
Chapter Fourteen
Appendix
Figure 14. Sling
Psychrometer
Figure 15. Wind Meter
2. Oil-sensitive paper, 76 mm x 52 mm [Stock No. 20302-1, Spraying Systems
Co., North Avenue at Schmale Rd., Wheaton, Illinois 60187 (available in package
of 50 cards)].
3. Saturation pad, 10 cm x 10 cm [Stock No. 7588, Alltech Associates,
Waukegan Dr., Deerfield, Illinois 60015 (available in boxes of 100)]. Extract with
methanol at least 10 cycles on Soxhlet apparatus prior to using for
organophosphate sampling.
4. Latex, nitrile, or vinyl gloves (for handling oil- and water-sensitive cards).
5. Posterboard (at least a 7-inch square).
6. Stapler (to attach paper to posterboard).
7. Nails or tape (to attach posterboard with papers to sample site support (i.e.,
fence, tree, building, etc.)
Pesticide Inspection Manual
A-32
January 1989
-------
Chapter Fourteen Appendix
Figure 16. Droplet Indicator Paper
8. Acetone-washed aluminum foil.
9. Data sheets, labels, official seals, plastic bags, dry ice, and sample container.
Procedure
1. Assemble paper sheets on posterboard by stapling side-by-side an oil-
sensitive paper, water-sensitive paper, and a saturation pad. Duplicate saturation
pads may be needed for certain analytical purposes such as quality control or
analyzing for more than one type of pesticide (consult with the laboratory).
2. Nail or tape the posterboard array of paper sheets (droplet indicator cards
and saturation pad) to a natural or artificial support at the sample station site. The
card should be placed horizontally and above the ground-covered canopy of
vegetation (shrubs, grass, crops, etc.).
3. Handle droplet card with clean gloves to prevent skin contact with oil- and
water-sensitive paper or saturation pad (see comment below.)
4. Lay out droplet card shortly before spraying occurs. Identify each sampling
location by cross-reference to a map or logbook entry.
5. Following exposure to spray application, retrieve droplet card, and examine
for stains; record onsite results in the field logbook.
6. Wrap entire droplet card in precleaned foil and place in a plastic bag.
Pesticide Inspection Manual A-33 January 1989
-------
Chapter Fourteen
Appendix
7. Label bag and officially seal for transport to laboratory packed in dry ice.
8. At the laboratory, the saturation pad is removed from the droplet card for
pesticide residue analysis. If necessary for analytical purposes, the 10-cm-square
pad can be cut in half.
Comment
One limitation of the water- and oil-sensitive paper technique is the problem of
being able to place the droplet cards at sampling locations shortly before a
pesticide application is to begin. Also, if care is not taken, oil or perspiration from
fingers may prestain the paper; latex, nitrile, or vinyl gloves are recommended
when handling the sampling cards. Another potential problem is that a very high
humidity (greater than 90%) may turn the water-sensitive paper light blue making
the darker blue stains produced by water droplets difficult to detect. The water-
and oil-sensitive cards should be stored in a dry, air-tight container prior to use.
Figure 17. PUF Column
Figure 18. Constant-Flow Vacuum
Pump with PUF Column
Pesticide Inspection Manual
A-34
January 1989
-------
Chapter Fourteen Appendix
PESTICIDE VAPOR MEASUREMENT
A leading source of pesticide complaints is disagreeable odors which are
associated with solvent or active ingredient vapors released during and following
spraying. Numerous organic vapor sampling devices have been used to collect
volatile pesticides; these include the MISCO Model 88, the Accu-Vol high volume
filter sampler and others. All have limitations of being fragile, bulky, heavy,
expensive, and electric powered. The sampling device described below is
expensive, but does not suffer from the other limitations, although the method was
developed for indoor use, it can also be used for exterior pesticide monitoring in air
for preplanned use compliance inspections. Although the sample-collection
materials are less than $10, the portable vacuum pump recommended costs $750
and a suitable calibration kit costs an additional $150 to $200.
Apparatus
1. Battery-powered, constant-flow vacuum pump and 110 volt, 60 Hz battery
charger (DuPont P-4000, E.I. duPont de Nemours & Co., Wilmington, Delaware)
flow rate 0.02-4.0 L/minute _±5%), weight 1.2 kg, rechargeable.
2. DuPont calibration kit [Stock No. 66-242-f-l (soap bubble meter) or
equivalent flow-rate meter, E.I. duPont de Nemours & Co., Wilmington, Delaware.
3. Polyurethane foam (PUF); Gaymar Identi-Plugs foam tube plugs [Stock No.
L 800-13; Gaymar Industries, Inc., One Bank St., Orchard Park, New York 14127
(available in bags of 200)]. 5% ethyl ether in hexane solution; at least 2 (32 cycles
each) with 5% ethyl ether in hexane on Soxhlet apparatus are needed to remove
impurities.
4. Glass tubing with 15 mm ID, 5-inch length.
5. Rubber septum, suitable to fit tightly over ends of glass tubing (air-tight
fitting).
6. Glass tubing, 3 mm ID; 4.5 cm length (disposable plastic 1 mL pipette cut
into 4.5 cm length is a satisfactory substitute for the glass tubing.)
7. Flexible tubing or hose (3-foot length is suitable for most uses.)
8. Acetone-washed aluminum foil and plastic bag for sample.
9. Data sheets, labels, official seals, shipping container, and dry ice.
Pesticide Inspection Manual A-35 January 1989
-------
Chapter Fourteen Appendix
Procedure
1. Assemble PUF* column centering two foam plugs in glass tubing; cap tube
ends with rubber septums. Pierce one septum with 4.5-cm-long piece of rigid
plastic (pipette) or glass tubing.
2. Attach flexible hose to septum tubing and vacuum pump.
3. Remove septum from one end of PUF column; calibrate vacuum pump for air
flow of at least 2 L/minute through the PUF column. (Calibration can be done in
the laboratory or office prior to and after field use.)
4. Wrap entire PUF column in clean foil for transport to sampling site.
5. At sampling site, remove foil and attach PUF column and hose to vacuum
pump. Operate vacuum for precise preselected time to pass 500 liters of air
through the PUF column. If possible, collect a duplicate air sample to submit to
the chemist for quality control analysis.
6. After sampling, disconnect PUF column and recap its open end with rubber
septum.
7. Rewrap used PUF column in clean foil, place it in a plastic bag and label it
for transport to the laboratory. Also wrap a clean, unused PUF column in foil and
submit it as a blank to the chemist for quality control.
8. In the laboratory, extract pesticides with appropriate solvents and report
results as weight of pesticide/cubic meter of air.
Comment
The PUF column vacuum pump described is lightweight, portable and operates
quietly. This makes it ideal for indoor sampling (structural or agricultural
pesticide monitoring). If used for indoor air sampling, the apparatus should be
placed at the center of the room near the normal breathing zone (3 to 6 feet above
the floor). Exterior agricultural monitoring is more variable and site selection
must be based on inspector judgment. At least two side-by-side samples for one
site should be collected for quality control purposes.
Actual testing has shown that the PUF column trapping efficiency for numerous
organochlorine, organonitrogen, organophosphorus, and pyrethoid pesticides is
greater than 75%. For specifics, refer to the Lewis and MacLeod publication or
contact NEIC at (303) 236-7970.
' Lewis, R.G., and MacLeod, K.E., 1982, "Portable Sampler for Pesticides and
Semivolatile Industrial Organic Chemicals in Air," Anal. Chem., 54:310-315.
Pesticide Inspection Manual A-36 January 1989
-------
Chapter Fourteen Appendix
NOTES
1. Hill, Dean, 1984 "Sampling and Analysis of Surface for Pesticides and PCBs,"
National Enforcement Investigations Center, U.S. Environmental Protection
Agency, Denver, Colorado, 7 pp.
2. Vials 28mm by 98mm, No. 22483; caps, open-top screw type, size 24-400, No.
240518; cap liners, TeflonR-facecl silicone, 24 mm No. 240588, Wheaton
Scientific, Milville, NJ 08332
3. Ibid
Pesticide Inspection Manual A-37 January 1989
-------
Chapter Fourteen Appendix
Pesticide Inspection Manual A-38 January 1989
-------
Pesticide Import and Export
Program
-------
Chapter Fifteen
PESTICIDE IMPORT AND EXPORT PROGRAM
Page No.
AUTHORITY 1
OBJECTIVES 1
POLICY 1
Exports 1
Imports 2
PROCEDURES 2
Importer 2
Regional Office 2
Customs 2
Inspectors 3
Inspections and Sampling 3
Inspection Without Sampling 3
Physical Sampling 3
Regional Office Procedure After Inspection 4
Merchandise Complying With the Act 4
Merchandise Not Complying With the Act 4
Exhibit 15-1: Federal Register Notice: Statement of Policy 5
Exhibit 15-2: Notice of Arrival of Pesticides and Devices (EPA Form 3540-1) 11
Exhibit 15-3: 19 CFR Part 12, Special Classes of Merchandise - Imported
Pesticides and Devices 13
Pesticides Inspection Manual 15-i January 1989
-------
Chapter Fifteen Pesticide Import and Export Program
Pesticides Inspection Manual 15-ii January 1989
-------
Chapter Fifteen
PESTICIDE IMPORT AND EXPORT PROGRAM
AUTHORITY
Section 17(a) of the Act states in part:
...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 of 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 (iii), 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 (1) notify the Administrator of
the arrival of pesticides and devices; and (2) deliver to the Administrator (upon his/her request)
samples of pesticides or devices that have been imported into the United States.
OBJECTIVES
The objective is to ensure that pesticides and devices imported into the U.S. comply with the
requirements of FIFRA. Those pesticides and devices that are found not to be in compliance should
be detained and, if those items are not brought into compliance, should be refused entry.
POLICY
Exports
It is the policy of the Agency that those pesticides that are intended for export be prepared and
packaged in accordance with the specifications and directions of the applicable foreign purchaser and
consistent with the EPA Statement of Policy on the Labeling Requirements for Exported Pesticides,
Devices, and Pesticide Active Ingredients and the Procedures for Exporting Unregistered Pesticides
(see Exhibit 15-1).
Pesticides Inspection Manual 15-1 January 1989
-------
Chapter Fifteen Pesticide Import and Export Program
Imports
Likewise, imported pesticides and devices are subject to the same registration and labeling
requirements, as domestically produced pesticides and devices.
PROCEDURES
Importer
Before pesticides or devices can be imported into the United States, the importer must submit a
Notice of Arrival (NOA) of Pesticides and Devices, EPA Form 3540-1 (see Exhibit 15-2) prior to the
arrival of the shipment in the U.S. The regional office shall (1) 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, and (2) return the completed NOA to the importer or his/her agent. Normally, a
customs 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 the 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 should maintain a cooperative working
relationship with the U.S. Customs Service and customs brokers. Upon receipt of the NOA, he/she
should review the NOA for completeness and determine whether to inspect/sample based on the
following priorities:
o Nonregistered pesticides/devices suspected of noncompliance;
o Pesticides/devices with a violative history;
o First-time import of a pesticide/device; and
o Pesticides/devices imported regularly with a good history of compliance.
If a decision is made to inspect the imported pesticide/device, Part II of the NOA will indicate
which of the following actions to take:
o Detain the shipment for inspection by EPA, or
o Release the shipment to the consignee under bond (shipment must be held intact pending
EPA inspection).
Part II of the NOA will be marked as appropriate, signed, and the appropriate copies returned
to the customs broker. The inspector will be notified to conduct an inspection and will receive a copy
of the NOA.
Customs
The U.S. Customs procedures are contained in the U.S. Customs Service regulations at 19 CFR
Part 12 (Exhibit 15-3).
Pesticides Inspection Manual 15-2 January 1989
-------
Chapter Fifteen Pesticide Import and Export Program
Inspectors
As directed by the regional office, the inspector should visit the ports to become familiar with
customs and import activities in his/her area of responsibility. The inspector should also develop a
good working relationship with customs officials and pesticide import brokers. A good working
relationship will ensure prompt and complete reporting of imported pesticides.
Inspections and Sampling
Because the pesticide/device is being detained pending the outcome of the inspection, it is
important that the inspection be conducted in an expeditious manner.
Upon arrival at the inspection site, the inspector should (1) introduce himself /herself to a
responsible person, (2) present his/her credentials and explain the purpose of the inspection, (3) issue
a Notice of Inspection (EPA Form 3540-2) with the reason for inspection, and (4) begin the
inspection.
Inspection Without Sampling
When conducting an inspection without sampling, the inspector should complete the following
steps:
o Review the label and labeling for mandatory label requirements. If a copy of the
registered label is available, it should be compared to the label on the container.
o Check for collateral labeling such as books, pamphlets, circulars, and displays.
o Check condition of the lot.
If a label or labeling violation is noted, however, a documentary sample should be collected (see
Chapter 11).
Physical Sampling
The regional office will determine when sampling is necessary and instructions will be given to
the inspector. (Refer to Chapter 11 for sampling procedures.) Documentation should include a copy
of photographs of the label/labeling, a copy of the NOA, foreign invoices and shipping records.
In general, the inspector should take the following steps when obtaining physical samples:
o Make a notation on the Receipt for Sample that it is an import sample.
o Submit the sample to the appropriate laboratory and ask the laboratory to expedite the
analysis.
o Inform the supervisor/import coordinator of the inspection results.
Pesticides Inspection Manual 15-3 January 1989
-------
Chapter Fifteen Pesticide Import and Export Program
Regional Office Procedure After Inspection
Merchandise Complying With the Act
If, upon examination or analysis of a sample obtained from a shipment of pesticides or devices,
the sample is found to be in compliance with the Act, the regional office shall notify the U.S. Customs
Service that the shipment may be released to the consignee.
Merchandise Not Complying With the Act
If, upon examination or analysis, the sample is found to be in violation of the Act, the regional
office must notify the consignee promptly of the nature of the violation and give the consignee
reasonable time to correct the problem. Following this, if it is still the opinion of EPA that the
pesticide/device is in violation of the Act, the regional office shall notify the U.S. Customs Service.
See 19 CFR Part 12.117(b) (Exhibit 15-3), which describes U.S. Customs procedures for merchandise
not complying with the Act.
Pesticides Inspection Manual 15-4 January 1989
-------
Chapter Fifteen
Exhibit 15-1
Federal Register Notice: Statement of Policy
50274 Federal Register / Vol. 45, No. 146 / Monday, July 28, 1960 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 162, 163, 164,165, 166,
167, 168, 169, 170, 171,172, 173, 174,
175,176,177,178, 179, and 180
(FRL 1S46-5J
Statement of Policy on the Labeling
Requirements for Exported Pesticides,
Devices, and Pesticide Active
Ingredients and the Procedures for
Exporting Unregistered Pesticides
AGENCY: Office of Enforcement,
Environmental Protection Agency (EPA
or the Agency).
ACTION: Notice of policy statement.
SUMMARY: The Federal Insecticide,
Fungicide, and Rodenticide Act (F1FRA
or the Act) was amended by the Federal
Pesticide Act of 1978 on September 30.
1978. Section 17(a) of the Act was
modified so that pesticides, devices, and
active ingredients used in producing
pesticides which are manufactured for
export must now bear certain minimal
labeling, and the producers of such
products are now subject to the
requirements of both FIFRA sections 7
(establishment registration) and 8
(books and records'). In addition, unless
a pesticide is registered under section 3
or is being sold under section 6(a)(l) it
cannot be lawfully exported unless,
prior to export. (1) the foreign purchaser
has signed a statement acknowledging
that the purchaser understands that the
pesticide is unregistered and therefore '
cannot be sold in the United States, and
(2) a copy of that statement has been
transmitted to EPA for transmittal to the
appropriate officials of the importing
country. This foreign purchaser .
acknowledgement statement must be
acquired by the exporter and
transmitted to EPA for the first shipment
of each unregistered pesticide to a
particular purchaser for each importing
country, annually.
This notice informs the public of the
scope of the new labeling requirements
and of the procedures that an exporter
of unregistered pesticides must follow to
acquire acknowledgement statements
which will be transmitted by the U.S.
Government to the government of the
importing country.
EFFECTIVE DATES: Labeling. Labeling
requirements for exported pesticides,
devices, and pesticide active ingredients
became effective March 29.1979,
(Federal Pesticide Act of 1978, Pub. L.
95-396. 92 Stat. 833). Therefore, exported
product* which fall within the purview
of this notice must now bea»lab»tfl
which comply wilhthe statutory
requirements of FIFRA section 17(a)(l).
Purchaser Acknowledgement
Statements. After thirty days from the
date of this notice, exporters of
unregistered pesticides will be in
violation of FIFRA if the foreign
purchaser acknowledgement statements
have not been acquired before shipment
and transmitted to EPA in accordance
with this policy.
FOR FURTHER INFORMATION CONTACT:
John ]. Neylan III. Office of Enforcement,
Pesticides and Tonic Substances
Enforcement Division (EN-342), EPA,
401 M Street. S.W., Washington, D.C.
20460 (202) 755-1212.
SUPPLEMENTARY INFORMATION: On
Wednesday. July 18.1979. EPA's Office
of Enforcement published a proposed
statement of policy on the labeling
requirements for exported pesticides,
devices, and pesticide active ingredients
and the procedures for exporting
unregistered pesticides. (44 FR 41955].
That proposed policy statement
explained in some detail what
information would be required to appear
on the labels or labeling of pesticides,
devices, or pesticide active ingredients
destined for export in order to be
considered in compliance with the law.
It also described the procedures for
acquiring from a foreign purchaser of
unregistered pesticides a statement in
which the purchaser acknowledges the
registration status of the pesticide. Both
of these requirements became effective
180 days aftertne date of enactment of
the Federal Pesticide Act of 1978 (March
29,1979).'
The July 18 notice invited the public to
comment on the proposed policy before
September 17,1979. Twenty-three
comments were received. Following Is a
summary of the major modifications to
the policy statement made as a result of
the comments.
(1) A more detailed explanation was
included of which products will be
considered as not registered for use in
the United States, for purposes of this
policy statement.
(2) The policy statement explains in
greater detail what labeling is expected
to appear on exported pesticides,
devices, and pesticide active
ingredients.
Appendix A contains summaries of
the comments made to the July 18,1979
policy statement and the Agency's
response to them.
Accordingly, the Office of
Enforcement's general statement of
policy on the labeling requirements for
exported pesticides, devices, and
pesticide active ingredients and the
1 Pub. L 95-398.92 Silt SIR. Stptimber SO, 1S7S,
Section 18(b).
procedures for exporting unregistered
pesticide are set forth below.
Dated: July 10.1960.
Jeffrey G. Miller.
Acting Assistant Administrator for
Enforcement.
I. Summary of Policy
Pesticides, devices, and active
ingredients used in producing pesticides
which are manufactured for export must
now bear labeling which will serve to
both identify the product and the
producer and to protect persons who
come in contact with the product.
Certain of the label items must be
written in both the English language and
in the language of the importing country.
These bilingual labeling requirements
apply to the product's ingredient
statement and its warning and
precautionary statements. Exporters of
pesticides which are not registered for
use in the United States (in accordance
with this policy) must obtain a
statement from the foreign purchaser o'f
the pesticide in which the purchaser
acknowledges the registration status of
the product. The pesticide must also
bear labeling to indicate that it is not
registered in the United States. For
purposes of this policy an unregistered
pesticide is one which (1) contains an
active ingredient not found in a
federally registered product: or (2) bears
labeling for a use which is currently
subject to denial or cancellation of
registration: or (3) is not similar in
composition and use pattern to a
federally registered product
The acknowledgement statement must
(1) identify the purchaser, the exporter,
the product's identity and the product's
destination; (2) be obtained for the first
shipment of a particular pesticide to a
particular purchaser for each importing
country, annually: (3) be obtained before
exportation takes place: and (4) be
transmitted to EPA within seven (7)
days of receipt by the exporter.
n. Labeling Requirements
Section 17(a) of FIFRA has been
amended to provide as follows:
(a) Pesticides and Devices Intended for
Export.—notwithstanding any other provision
of Qua 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 packaged according
to the specifications or directions of the
foreign purchaser, except thai producers of
•uch pesticides and devices and active
ingredients used in producing pesticides shall
be subject to sections 2(p). 2(q)(l)(A), (C). (D).
(E), (C), and (H). 2(q)(2)(A), (B). (C)(i) and
(ill), and (D). 7, and 8 of this Act:
Pesticides Inspection Manual
15-5
January 1989
-------
Chapter Fifteen
Exhibit 15-1
Federal Register / Vol. 45, No. 146 /' Monday, July 28. 1980 / Rules and Regulations 50275
Every exported pesticide, device, and
active ingredient used in producing a
pesticide must bear a label or labeling,
in English or in the language of the
importing country, which meets the
requirements of FIFRA section 17(a)(l).
In addition, certain information which
will satisfy FIFRA sections 2(q)(l)(E),
(C), and (H) and 2 (q)(2)(A) and (D) must
also appear on the label or labeling so
as to provide bilingual (in other words,
in English and in the language of the
importing country) information to
anyone who handles or comes in contact
with these products. Any language in
which official government business is
conducted in the country or which is the
predominately spoken language of the
country, is acceptable as the second
language on the label.
Pursuant to Section 17(a)(l), all
exported pesticides, devices, and active
ingredients used in producing pesticides
must bear labels or labeling which:
(a) bear EPA Establishment Numbers;
(b) have ingredient statements;
(c) have the name and address of the
producer or registrant;
(d) have statements of net weight or
measure;
(e) if highly toxic, bear skull and
crossbones and statements of practical
treatment in case of poisoning;
• (f) include warning and caution
statements; •
(gj do not make false representations;
(h) are not in imitation of other
products; and
(i) in the case of unregistered
pesticides, bear the statement "Not
Registered for Use in the United States
of America."'All such required
statements must tre conspicuous and
readable.
To satisfy FIFRA section 2(q)(l)(E),
the labeling provisions set forth below
must appear in the English language and
in the language of the importing country.
This section specifies that required
stalements must be represented ". . . in
such terms as to render it likely to be
read and understood by the ordinary
individual . . ."^Therefore, the following
information must appear bilingually on
exported product labeling:
(a) the warning and caution
statements:
(b) the ingredient statement;
(c) where required, the word "poison"
and the statement of practical treatment;
and
(d) the statemerrf^'Not Registered for
Use in the United States of America."
The following may provide more
specific guidance on particular elements
which must appear on the label or
labeling of each exported product:
a. EPA Establishment Number. The
Establishment Number may appear
anywhere on the label or immediate
container in accordance with the
establishment registration labeling
requirements set forth in 40 CFR
5162.10(0-
b. Precautionary.Statements. Warning
or caution statements must be biligual
and must be adequate for the protection
of persons handling the pesticide,
particularly with respect to general
lexicological hazards and
environmental, physical, or chemical
hazards. Where the bilingual translation
is obviously inappropriate to protect
residents of the importing country, (for
example, where a label calls for a gas
mask meeting the specification of the
U.S. Bureau of Mines) an equivalent
caution may be substituted.
c. Unregistered Products. Labels of
pesticides which are not registered
under FIFRA (See Products Subject to
the Requirement for an
Acknowledgement Statement below)
must prominently display the following
statement: "Not Registered for Use in
the United States of America." This
statement must appear bilingually.
d. Ingredient Statement. The
ingredient statement must appear
bilingually unless the ingredients are
easily identifiable despite their being
listed in a foreign language.
e. Use Classification Statement. The
statement of use classification
(Restricted Use Pesticide or General Use
Pesticide) must appear on the labeling of
the pesticide; however, summary
statements regarding the terms of the
restriction, e.g., "For retail sale to and
application only by Certified
Applicators . . ." are not required.
f. Identity of Parties. Name and
address of the producer, registrant, or
person produced for must appear in the
labeling.
g. Net Weight. The net weight must
appear on the labeling in either
conventional English units or metric
units.
h. Highly Toxic Pesticides. If the
pesticide is highly toxic, the skull and
crossbones, the word "Poison", and a
statement of practical treatment must
appear on the labeling. The word
"Poison" and the statement of practical
treatment shall be bilingual. The skull
and crossbones may be in red or black.
For guidance on what pesticides are
highly toxic, see 40 CFR § 162.10 (hi.
The Agency is concerned that labeling
required by FIFRA not conflict with
labeling requirements of the importing
country. Such a situation might arise, for
example, where pesticides are being
" exported to a foreign country with strict
labeling and registration laws such as
this country has. To avoid such potential
conflicts, yet still meet the statutory
requirements of FIFRA, exporters may
use supplemental labeling. Pesticides,
devices, and active ingredients used In
producing pesticides may, therefore,
bear a label with the appropriate
information required by FIFRA section
17(a)(l) or may be accompanied by
supplemental labeling in instances
where FIFRA required labeling is in
contravention of foreign labeling
requirements. Supplemental labeling
may be attached to or accompany the
product container or shipping container.
HI. Foreign Purchaser Acknowledgment
Statement
Section 17 of FIFRA has been further
amended to provide as follows:
(a) Pesticides and Devices Intended for
Export.—Notwithstanding any other
provision of this Act no pesticide or device
or active ingredient used in producing a
pesticide intended solely for export lo any
foreign country shall be deemed in violation
of this Act—
(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 the
Act. A copy of that statement shall be
transmitted to an appropriate official of the
government of the importing country.
This notice also delineates what
pesticide products are affected by this
provision and procedures EPA believes
would satisfy the purposes of section
17(a)(2).
TV. Products Subject to the
Requirements for an Acknowledgment
Statement
Many pesticides which are produced
in the United States solely for export
contain active ingredients that are also
registered as components of pesticides
used within the United States. However,
the export formulations in many cases
contain slightly different percentages of
active ingredients and are labeled
differently. Several factors dictate these
minor modification:! in formulation and
labeling, such as different systems of
measurement, pests to be controlled
which are different from those for which
the same or a similar pesticide product
is used in the United States, and
requirements for labeling in a language
other than English.
The Agency believes that Congress
did not intend the requirement for
obtaining an acknowledgement
statement which is applicable to
"unregistered" pesticides to apply to
products which are minor variations on
formulations registered in the United
States and which contain only active
Pesticides Inspection Manual
15-6
January 1989
-------
Chapter Fifteen
Exhibit 15-1
50276 Federal Register / Vol. 45. No. 146 / Monday, July 28. 1980 / Rules and Regulations
ingredients which are registered in the
United States. Rather, it is the Agency's
view that the export amendments were
meant to apply in cases in which either
(1) an adverse decision concerning the
use of the pesticide in the United States
has been made, or (2) no decision-has
been made concerning use of the
pesticide. The requirement for obtaining
an acknowledgement statement from a
foreign purchaser will apply to pesticide
products in which:
(a) The pesticide active ingredient has
been judged to pose "unreasonable
adverse effects" to man or the
environment, and the registrations of
products with that active ingredient
have been cancelled or denied; or
(b) Either, (1) no assessment or no
conclusive assessment of the hazard
resulting from use of the pesticide has
been made by EPA (while the pesticide
may have been used under limited
experimental or emergency conditions),
(Z) the pesticide has never been
registered under section 3 because
registration for the pesticide active
ingredient has not been sought or has
not yet been granted, or (3) the pesticide
is being exported for a use which is
substantially different from any
currently registered use of that pesticide
(e.g., a pesticide which is registered in
this country for use as a termiticide it
exported bearing directions for use on
food crops).
Consequently, the Agency interprets
section 17(a)(2) to apply to:
(a) All pesticide products which
contain an active ingredient that is not
found in a federally registered product;
(b) Ail pesticide products bearing
labeling for a use which is currently
subject to denial or cancellation of
registration (section 17(a)(2) will also
apply to uses not considered by the
Administrator during a cancellation or
denial determination); and
(c) All pesticide products which are
not similar in composition and use
pattern to a federally registered product.
To be considered similar in
composition and use pattern, a pesticide
product must contain only the same
ingredient or combination of active
ingredients and must have the same
category of toxicity as a federally
registered product. Also, the use pattern
must be similar to the use pattern of the
federally registered pesticide to which it
it being compared. Registrations
involving changes in use patterns such
at changes from non-food to food use,
outdoor to indoor use, terrestrial to-
aquatic use, or non-domestic to
domettic use, are not considered to
qualify ai similar u»e patterns. Pesticide
uses which were never reviewed during
• cancellation or denial of reflitrtlion
determination (such as a pesticide use
on a crop which is not grown in the
United States) also do not qualify as a
similar use.
Pesticide products which are subject
to the requirements of section 17(a)(2)
must also bear the label statement, "Not
Registered for Use in the United States
of America" stipulated by section
2(g)(l)(H)ofthis Act.
A pesticide product which has been
registered under Section 24(c) of F1FRA
will be considered as registered for
purposes of this policy. A pesticide
product which may be legally used only
under an experimental use permit
(Section 5) or an emergency exemption
(Section 18) will not be considered as
federally registered. Nor will a pesticide
product whose distribution and use are
legal in intrastate commerce because the
producer has filed an application for
federal registration in accordance with
the procedures found in 40 CFR § 162.17.
Technical grade and manufacturing use
pesticides which are not federally
registered will be considered as
registered for purposes of this policy, if
they qualify as being similar in
composition to a registered formulation
use pesticide, (i.e., if the products have
the same active ingredients and
category of acute toxicity).
V. Procedures
Section 17(a)(2) requires that before a
pesticide which is not registered for-use
in the United States can be exported, the
foreign purchaser of the pesticide must
acknowledge in writing that he
understands the registration status of
the pesticide and that the pesticide
cannot be sold in the United States. An
exporter of unregintered pesticides must
have received the required
acknowledgement statement before the
product is released for shipment. The
Agency feels that requiring exporters to
have in hand the purchaser
acknowledgement statement before
exportation takes place is the only way
to assure that foreign purchasers comply
with these new FIFRA export
requirements. The Agency recognizes
that this requirement may cause some
disruption in the export of pesticides.
However, any such delays will be
visited only upon exporters of
unregistered pesticides, and then only
for the first shipment to a foreign
purchaser, in a particular country,
annually. The information required on
the acknowledgement statement, along
with a certification signed by the
exporter, mutt be transmitted to the
Environmental Protection Agency within
seven days of receipt by the exporter, or
by the date of export, whichever occurs
Brst The certification mutt state that
the shipment did not take place before
the exporter had the signed
acknowledgement statement in hand.
The Agency will consider the receipt
of purchaser acknowledgement
statements by local company
representatives in foreign countries to
be receipt by the exporter. Nevertheless,
ihe information required by the
acknowledgement statement must still
be transmitted to EPA within seven
days of receipt, or by the date of export,
whichever occurs first.
Acknowledgement statements may be
acquired at any time in advance of
shipment. For example, an exporter that
ships to the same foreign purchasers
year after year may acquire at the
beginning of a year all of the
acknowledgement statements which are
anticipated to be needed.
The Agency will transmit the
acknowledgement statements to
appropriate foreign officials through the
Department of State. Statements will be
transmitted promptly after receipt
The Agency believes that the purpose
of the purchaser acknowledgement •
statement is to advise foreign
governments that pesticides which have
been judged by the United States to be
hazardous to human health or the
environment, or pesticides for which no
hazard assessment has been made, are
being exported by U.S. producers to
their country. Foreign governments may
then use such information as they
desire, perhaps, for example, in
evaluating the risk of continued use of
the pesticide in that country versus the
benefits that pesticide provides. The
Agency does not consider that the
acknowledgement statement is primarily
intended to serve as preshipment
notification to foreign governments in
order that they may intercept shipments
of such pesticides. Nevertheless,
because of the Agency's concern that
acknowledgement statements reach
foreign governments in a timely manner,
the information contained in the
acknowledgement statement will be
forwarded to foreign governments
promptly upon receipt by EPA.
As an information mechanism, the
purchaser acknowledgement statement
serves the purpose of alerting the foreign
government that a certain pesticide U
entering its country. The Agency
believes that the first notice fulfills this
.purpose; repetitive notices would be of
only marginal value, and in cases of a
high volume of exports to a foreign
country, might result in a flood of paper.
After considering the administrative
burdens placed on exporters, EPA. and
foreign governments and the value of
repetitive notices, the Agency hat
concluded that each exporter should
Pesticides Inspection Manual
15-7
January 1989
-------
Chapter Fifteen
Exhibit 15-1
Federal RegUter / Vol. 45. No. 146 / Monday. July 28. 1980 / Rules and Regulations 50277
complete and have signed a purchaser
acknowledgement statement for the
first shipment of a particular product to
a particular purchaser for each
importing country, annually. A shipment
of the same product to a different
purchaser or to the same purchaser for
disposition to a different importing
country would also trigger the
requirement for obtaining a signed
acknowledgement statement from the
foreign purchaser. A second shipment,
during the same calendar year, involving
the same product, purchaser, and
Importing country would not trigger this
requirement. Any change in the
variables—different purchaser, different
product different importing country—
will result in the need for obtaining a
new purchaser acknowledgement
statement
In summary, the procedures that an
exporter of unregistered pesticides must
follow in obtaining and transmitting
foreign purchaser acknowledgement
statements are:
(a) The exporter must provide the
foreign purchaser with instructions
about the required information on an
acknowledgement statement and inform
the foreign purchaser that shipment of
the pesticide cannot be undertaken
unless the exporter has received from
the foreign purchaser a properly
completed, signed, and dated
acknowledgement statement;
(b) The exporter must secure, prior to
shipment an acknowledgement
statement which contains the
information outlined in the Required
Information section of this notice. Such
a statement must be secured for the first
purchase each year of a particular
pesticide product by a foreign purchaser
destined for a particular country;
(c) The exporter must forward the
information required on the
acknowledgement statement along with
the certification that exportation did not
take place until a signed
acknowledgement statement was
received, within seven (7) days of
receipt, or by the date of exportation,
whichever occurs first, to the following
address: Environmental Protection
Agency, Pesticides and Toxic
Substances, Enforcement Division (EN-
342), 401 M Street SW.. Washington,
D.C. 20460.
Attention: Export Acknowledgement
Statement.
VI. Required Information
As previously stated, a foreign
purchaser of a pesticide which is not
registered for use in the United States
must sign a statement acknowledging
his understanding that the product is
unregistered and cannot be sold in this
country. The Agency doei not Intend to
prescribe a format for this
acknowledgement statement. However,
•the statement must include the following
information:
(a) Name and address of the exporter;
(b) Name and address of the foreign
purchaser
(c) Name of the product and the active
ingredient and an indication that the
purchaser understands that the product
is not registered for use in the United
States;
(d) Destination of the export shipment
if different than purchaser's address;
(e) Signature of the foreign purchaser;
and
(f) Date of the foreign purchaser's
signature.
YD. Confidentiality
Persons submitting the information
specified in Part VI may assert a claim
of business confidentiality by marking
this information as "FIFRA Confidential
Business Information." Information so
marked will not be disclosed, with the
exception of disclosure to the foreign
government, except in accordance with
the procedures set forth in 40 CFR Part
2.7 USC 136h, and this policy statement.
If such claim is not asserted, EPA may
disclose1 the information to the public
without providing notice of disclosure or
an opportunity to object.
Notwithstanding any claim of
confidentiality, the acknowledgement
statement will be forwarded to the
appropriate foreign government in its
entirety as required by section 17.
Vm. Relationship to Other Statutory
Requirements
Producers of pesticides, devices, and
active ingredients used in producing
pesticides which are intended for export
are subject to the establishment
registration procedures, including the
report requirements, as well as the
record keeping requirements of FIFRA.
The Agency has proposed amendments
to the regulations which are
promulgated under the authority of
those parts of the Act (sections 7 and 8)
to bring them into conformity with the
newly amended FIFRA. These
regulations are found at 40 CFR Part 167
and Part 169, respectively.
Pesticides, devices, and pesticide
active ingredients for export are not
considered to be in violation of FIFRA
when produced according to the
directions of the foreign purchaser,
when properly labeled and, in the case
of unregistered pesticides, when the
foreign purchaser has signed a
statement in which he acknowledges
that he understands the registration
status of the pesticide and the exporter
has forwarded the statement to EPA.
Exported pesticides, devices, and active
ingredients used in producing pesticides
which do not bear labels or labeling In
compliance with FIFRA section 17(a)(l)
will be considered to be misbranded
Exporters of such products-will be
subject to civil or criminal liabilities for
violation of FIFRA sections 12(a)(l) (D)
or (E)—misbranding. Exporters of
unregistered pesticides will be subject to
civil or criminal liabilities for violation
of FIFRA section 12(a)(l)(A)—selling or
distributing a pesticide which is not
registered—if they fail to secure, prior to
export a properly completed, signed,
and dated acknowledgement statement
from the foreign purchaser of the
pesticide. Falsification of the required
certification may subject an exporter to
sanctions under 18 U.S.C. 1001.
Appendix A.—Significant Comments
and Responses
General Comments
Comment No. 1. Applicability of
Rulemaking Procedures. Two*
commenters stated that the Agency
should have implemented the export
provisions of FIFRA through the
procedures established by the
Administrative Procedures Act for the
promulgation of "substantive" rules. The
Agency disagrees. As mentioned
previously, these requirements for
export labeling and purchaser
acknowledgement statements were
statutorily effective March 29,1979,180
days from enactment of the Federal
Pesticide Act of 1978. The law lists the
type of information required on an
exported pesticide's labeling and the
legislative history makes it clear that
purchaser acknowledgement statements
are to be transferred to foreign
governments in the same manner that
cancellation notices are furnished. The
Agency's position, therefore, is that
there is no need for rulemaking but
rather there is a need for a general
statement of policy on such matters as:
(a) what would constitute minimally
acceptable labeling, (b) how such
labeling could be attached or
accompany shipments, and (c) how
foreign purchaser acknowledgement
statements are to be transmitted to
foreign governments.
Comment No. 2. Use of Suspended
and Cancelled Pesticides List. Another
commenter suggested that foreign
countries can be adequately informed of
the hazards of U.S. manufactured
pesticides through an expansion of the
Suspended and*Cancelled Pesticides
List. This is not the intended function of
the Suspended and Cancelled Pesticides
List. That list constitutes only a guide
Pesticides Inspection Manual
15-8
January 1989
-------
Chapter Fifteen
Exhibit 15-1
50278
Federal Register / Vol. 45, No. 148 / Monday, July 28,, 1980 / Rules and Regulations
for Government officials; it ia not the
final authority on the status of a given
pesticide. It is the intent of Congress
that the procedures that are followed for
notifying foreign governments of the
suspension or cancellation of pesticides
be those which are also used to inform
them that an unregistered pesticide will
be entering their country. Therefore, the
channel of communication described in
this policy is derived from the
procedures already used to notify
foreign governments of major
suspension or cancellation actions.
Comment No. 3. Scope of the FIFRA
Section 17 Requirements. A number of
commenters addressed the definition
contained in this policy statement of an
unregistered pesticide. The Agency
agrees that clarification on this point is
necessary. It is not EPA'3 intent to limit
export of a chemical if it is properly
labeled and the exporter complies with
the procedures for obtaining and
transmitting to EPA a properly executed
acknowledgement statement. A more
detailed explanation of which products
will be regarded as unregistered for the
purposes of this policy has been given.
One commenter objected to including
products with denied or cancelled uses
and products with different composition
or use patterns with products which
contained no registered active
ingredient. In drafting this policy
statement EPA adopted a broad
interpretation of the registration status
of a pesticide.
The Agency could have required
exporters of all pesticide products that
were not registered under section 3 to
acquire an acknowledgement statement
from the foreign purchaser. The effect of •
this would be that an acknowledgement
statement would have been required for
the overwhelming majority of exported
pesticides since most exports differ
slightly in formulation or directions for
use from the U.S. registered product,'or
the labels are written in a foreign
language. The EPA clearly stated in the
proposed policy statement that in its
view Congress did not intend that
exported products with minor variations
from EPA registered pesticides be
subject to the export notification
procedures. However, products with
cancelled uses or with substantial
differences in composition or use
patterns cannot be considered products
with minor variations. The Agency must,
therefore, reject this comment.
Comment No. 4. Status of Certain.
Unregistered Pesticides. One commenter
suggested that experimental use
product* be treated as registered <
product*; another commenter thought
that products with temporary tolerances
should be considered as if they were
registered. Since registration data for
such products are not complete, it has
consistently been Agency policy to treat
experimental use products and products
with temporary tolerances as
unregistered products. Products which
bear registrations under section 24(c) of
FIFRA will, however, be treated as
registered products. Products undergoing
Rebuttable Presumption Against
Registration will be considered in
accordance with their registration status
at the time of export. It was suggested
by one commenter that those pesticides
which were registered by a foreign
coufitry should not be subject to the
requirement for an acknowledgement
statement. In order to adequately
enforce a policy which took this
approach, the EPA would have to
evaluate the internal registration
procedures conducted by other countries
and to regulate exports based upon the
policies of the importing country. Thus,
EPA policy would be different for
similar shipments going to different
countries. The Agency rejects this
comment. Not only would it be
administratively difficult to operate such
an export program, but such a policy
fails to recognize the point of having the
acknowledgement statement: To inform
foreign governments of the U.S.
registration status of a pesticide.
Comment No. 5. Non-Commercial
Exportation. Another commenter
requested clarification on the
application of the notice provision to
pesticides which are exported without a
commercial transaction. There are two
possible categories of products to which
this comment might, apply: the first
would be smalt amounts of pesticide
exported for research purposes only; the
second would be large shipments
exported to a foreign establishment of
the domestic company which
manufactures it. Research quantities are
subject to the labeling rules of this
policy but not to the acknowledgement
statement requirement. Large shipments
transferred from a domestic facility to a
foreign facility of the same company will
be treated in accordance with their U.S.
registration status, that is, if the product
is registered (in accordance with the use
of that term in this policy), no
acknowledgement iitatemerrt is required:
if the product is not registered, an
acknowledgement utatement will be
required.
Comment No. 6. Technical and
Multiple Use Chemicals. Some
commenters asked for clarification of
the impact of this policy upon
formulated and technical grade products
and multi-use products. Formulated and
technical grade products which are
subject to FIFRA are subject to this
policy. The label on the exported
product must comply with section 17 of
FIFRA. A multi-use product for which no
pesticide claims are made and which is
not an active ingredient in any pesticide
product in the United States is not
subject to this policy, even if it is
subsequently processed into a pesticide
in another country.
Labeling Comments
Comment No. 7. Use of Bilingual
Labeling. A number of commenters
stated that the law did not require
bilingual labeling. The law states that an
exported pesticides, device, or pesticide
active ingredient must bear labeling in
conformance with FIFRA section
2(q)(l)(E). The FIFRA states in section
2(q)(l)(E) that a pesticide is misbranded
if:
Any word, statement, or other information
required by or under authority of this Act to
appear on the label or labeling is not
prominently placed thereon ... in such
terms as to render it likely to be read and
understood by the ordinary individual under
customary conditions of purchase and use:
(Emphasis added.)
The EPA interprets this passage to
apply to ordinary individuals in the
importing country as well as in the
United States. Thus, the bilingual
requirements are meant to communicate
some .basic information about the
product to as many handlers of the
pesticide as possible. International
symbols, suggested by one commenter,
could not adequately communicate all
the required label elements, although
they may be used in addition to the
required wording. Commenters asked
for guidance regarding EPA's
enforcement of the bilingual requirement
in two specific instances: when the
importing country has several official
dialects, or when English is an official
government language. Any language in
which official government business is
commonly conducted in the country, or
which is the predominately spoken
language of the country, is acceptable as
the second language on the label. If
English is one of these languages, then a
bilingual label is optional, except as
may be required by the importing
country. One commenter asked if a
translation of the U.S. label would be
satisfactory. Such a label would be
acceptable if the necessary elements
appeared both in English and in the
foreign language.
Comment No. 8. Foreign Labeling
Requirements. Several commenters
asked about the application of this
policy to labels which comply with the
laws ofihe importing country. It is not
Pesticides Inspection Manual
15-9
January 1989
-------
Chapter Fifteen
Exhibit 15-1
Federal Register / Vol. 45. No. 146 / Monday, July 28. 1980 / Rules and Regulations 50279
the Intention of this policy to supersede
the labeling requirementsof foreign
governments. However, FIFRA now
requires that exported pesticides,
devices, and pesticide active ingredients
bear certain minimal labeling. If the
labeling which currently appears on
exported pesticides does not meet the
minimum FIFRA requirements, even
though it may meet the foreign country's
requirements, additional labeling must
be added to satisfy U.S. law.
Comment No. 9. Supplemental
Labeling. Several commenters suggested
that supplemental labeling be liberally
allowed. The Agency intends to be as
flexible as possible in this respect.
Exporters will be permitted to use a
variety of types of labeling to comply
with the FIFRA export requirements.
The Agency's principal interest will be
to ascertain that products to which this
policy applies bear labels or labeling
which, taken together, conform to the
FIFRA section 17(a)(l) requirements.
Comment No. 10. Establishment
Numbers. One commenter requested the
option of substituting another code for
the EPA Establishment Number on the
label. The Act clearly requires that an
Establishment Number appear on the
label. The Agency must reject this
suggestion since permitting other means
of identifying the production
establishment would negate the
usefulness of such numbers.
Comment No. 11. Restricted Use
Pesticides. Several commenters
requested guidance on label
requirements for exported restricted use
pesticides. If the product is a restricted
use pesticide, then the statement
"Restricted Use Pesticide" must appear
on the label or labeling. The
supplementary statement of the terms
and conditions of restriction is not
required.
Acknowledgment Statement
Comment No. 12. Prior Possession of
Acknowledgement Statements. A .
number of commenters questioned the
requirement that the acknowledgement
statements be in the exporter's
possession before shipment of the
pesticide can take place. Other
commenters stated that in their opinion
foreign importers, through oversight or
bureaucratic inefficiency, will not
comply with the acknowledgement
statement requirement. In the proposed
policy statement, the Agency clearly
recognized the problem of non-
compliance by foreign importers. For
this precise reason, EPA must reject the
contention that acknowledgement .
statements should not be required to be
in the exporter's oontrol before shipment
can take place. A more liberal
interpretation of what constitutes
receipt of the acknowledgement
statements has been'provided in the
final policy statement to facilitate
compliance. One commenter suggested
that a signed acknowledgement in the
hands of a local company representative
be considered a receipt by the exporter.
The Agency agrees that this would be
acceptable so long as the information
required on the acknowledgement
statement is sent to EPA within the
stated time period. If a company
anticipates several orders in a year, the
acknowledgement statements may be
obtained in advance of the actual order.
One commenter stated thai the
requirement that acknowledgement
statements be sent to EPA within seven
days of receipt by the exporter was too
restrictive. This commenter suggested
that transmittal of the acknowledgement
statement should be tied to the date of
shipment. The Agency disagree* Where
possible, acknowledgement statements
will be sent to foreign governments as
far in advance of shipment as possible.
This will provide the government some
time to review the information received.
The Agency feels more timely
notification will occur if transmittal of
the acknowledgement statement is tied
to date of receipt.
Comment No. 13. Certifications. Some
commenters objected to filing, along
with the acknowledgement statement, a
certification that the order was not
shipped before the acknowledgement
statement was received. The Agency
believes that a certification statement is
necessary. While some monitoring of
compliance will be through inspection of
required books and records, a
certification requirement will serve to
remind exporters that shipment must
wait until the acknowledgement
statement has been received.
Comment No. 14: Destination of
Shipment. One commenter suggested
that there was no need to include in the
acknowledgement statement the
destination of the export shipment, if
different than the purchaser's address.
This comment is rejected because
without this information the Agency
would be unable to determine if the
labeling complied with the bilingual
requirements nor would it know the
proper place to send the
acknowledgement statement.
Comment No. 15. Annual Reporting.
Several commenters stated that the
requirement that a new
acknowledgement statement be
acquired each year that a particular
product is exported is overly
burdensome. They point out that the law
requires an acknowledgement statement
only once per country, not once per
country, per year. The Agency must
reject this comment. Although FIFRA It
not clear on this point the law seems to
indicate that an acknowledgement
statement should be acquired for each
export shipment of an unregistered
pesticide. It is the Agency's position that
imposing such a requirement would be a
burden for all parties concerned—
exporters, importers, and the U.S.
Government, as well as foreign
governments—beyond any regulatory
purpose it may serve. The requirement
to send an acknowledgement statement
once per year, which is similar to that
being considered under the Toxic
Substances Control Act, is not overly
burdensome, and yet accomplishes the
purpose of regular notification to foreign
governments.
Comment No. 18. Notification of
Foreign Governments. Several
commenters questioned the procedure
for notifying foreign governments. It was
suggested that either the foreign
purchaser or the exporter should
directly notify the foreign government.
The EPA rejects this proposal. First, it
would be difficult, if not impossible, for
the Agency to monitor compliance under
such a procedure. Second, as previously
explained, the procedure for
transmitting acknowledgement
statements parallels that of the
notification of foreign governments of
suspended or cancelled registrations. It
is the understanding of the Agency that
such a procedure, namely government-
to-government contact, was the intent of
Congress.
Comment No. 17. Problems with
Importing Countries. Two commenters
suggested that the policy be different for
socialist or communist countries. These
commenters cited their experience
exporting pesticides to these countries
where the "importer" is an agency of the
government. These import agencies are
said by the commenters to be staffed by
very conservative bureaucrats who are
reluctant to sign unusual requests. As
has been discussed earlier, it is not the
intent of this Agency to write a different
export policy for different countries.
However, should numerous problems
arise with any particular country, the
Agency will work with industry and the
Department of State to solve them.
|FR Doc. 80-2:OS5 Filed --25-90: Hi am|
BILLING CODE «580-01-M
Pesticides Inspection Manual
15-10
Jannary 1989
-------
Chapter Fifteen
Exhibit 15-2
Notice of Arrival of Pesticides and Devices (EPA Form 3S40-1)
NOTICE OF ARRIVAL OF
PESTICIDES AND DEVICES
NOTE: Read Instructions on reverse before completing form.
Form Approved
OMB No. 2070-0020
expires 3-31 -SB
Address of EPA Office
PART 1 TO BE COMPLETED BY IMPORTER OR HIS AGENT
Code/
Customs Broker
1 Commerce Street
New York, NY 10014
Diatomaceous Earth Co.
1 King Street
Dover , England
100% Diatomaceous Earth
50 t 700 bags 35,000 t
12. PORTOFENTRV
Brooklyn , NY
1. NAME AND ADDRESS OF CONSIGNEE (Include Zip Code)
Good Earth Chemical Co.
100 Main Street
Vineland, NJ 08360
0000-1 MEMTN00000-EN-1
Diatomaceous Insecticide, Technical
England
11. CARRIER
H/V Good Luck
DE 1-700
17. LOCATION OF OOOOS KOR EXAMINATION
Pier 7, Brooklyn
21 . REMARKS
INVOICE DATA
ia. NUMBER If. DATE 20. PLACE
0001 11-21-88 Liverpool
DRNTIAL BUSINESS INFORMATION ISSHOWNIN THE'ABOVB
• LOCKS NUMBERED:
2,7
11. SIGNATURE cnciMPOfrrAR OR AGENT 14 DATE
JCa/rvc ooiirv\^ ATTY IN FACT 12/1/88
PARTXJ ) TO BE COMPLETED BY U.S. ENVIRONMENTAL PROTECTION AGENCY
Action to be taken on shipment by U.S. Customs:
1 1 Release shipment.
S] Detain shipment for inspection by EPA
LJ Release shipment to consignee under bond. Shipment must be held intact pending EPA inspection.
l~l Sample desired under provisions of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended and Customs Regulations 19 CFR
12.116. Please forward a sample of the merchandise identified above, together with all accompanying labels, circulars, and advertising
matter pertaining to such merchandise, to the address shown above. If it is necessary to take subsamples from bulk containers, contact
the EPA office for sampling instructions:
CD Other (Specify):
REMARKS
ft fife&i/^ o^*^v_ 4 h JM ^>
-------
Chapter Fifteen Exhibit 15-2
INSTRUCTIONS
Customs Regulations, 19 CFR Part 12.112, requires an importer desiring to import pesticides or devices into the United
States to submit EPA Form 3540-1, Notice of Arrival of Pesticides and Devices, to the U.S. Environmental Protection
Agency prior to the arrival of the shipment in the United States.
This form will be used by:
1. Importers to notify EPA of intended importations of pesticides and devices,
2. EPA to notify U.S. Customs of the status of such pesticides or devices pursuant to the FIFRA and to give instructions
regarding the handling of the shipment insofar as EPA is concerned, and
3. U.S. Customs to inform EPA of the disposition made of each shipment.
Importer or Agent - Part I of the form will be completed to the maximum extent possible by the importer or his agent. If
the product is a device, write the word "device" in the EPA Registration Number box. It may be necessary to complete
some of the items at the time of entry, e.g., entry data, carrier, marks and numbers, location of goods and invoice data. To
expedite the handling of pesticide shipments, this form should be submitted to the EPA office shown in the upper right
corner of the form prior to the arrival of the shipment. The importer will retain the Importer's Copy (goldenrod) for his
files.
INSTRUCTIONS FOR CLAIMING BUSINESS CONFIDENTIALITY
The importer or his agent may assert a business confidentiality claim covering part or all of the information appearing in Part
I of this form. If a claim is asserted, information covered by the claim will be disclosed by EPA only to the extent and by
means of the procedures set forth in EPA's regulations in 40 CFR Part 2 (appearing in 41 Federal Register page 36902,
September 1,1976). If no claim is made on this form, the information appearing on the form may be made available to the
public by EPA without further notice to the importer or his agent.
If the importer or his agent desires to assert a claim of business confidentiality covering some or all of the information appear-
ing in part I of the form, the importer or his agent must, in block 22, list by their numbers the blocks in Part I of the form in
which information appears, to which the claim applies.
EPA - Part II of the form will be completed by EPA. Directions must be specific regarding the action EPA wants Customs
to take regarding the importation. EPA will retain the EPA Copy (pink) for their files and return the other two copies to the
importer or agent for presentation to Customs at the time of entry.
Customs - The information shown on this form will be compared with the entry documents and the shipment by Customs.
Any discrepancies noticed should be brought to the attention of EPA before the shipment is released and be noted in the
remarks section. If the importation is not handled by Customs in the manner instructed in Part II, this should also be noted
in the remarks. After signing'the form, Customs will return the Official File Copy (white) to EPA and retain the Customs
Copy (canary).
EPA Form 1540-1 (R.v. 5-77)
Pesticides Inspection Manual 15-12 January 1989
-------
Chapter Fifteen
Exhibit 15-3
19 CFR Part 12, Special Classes of Merchandise:
Imported Pesticides and Devices
IHta 19—Cnctomt Outlet
CHAPTER I—UNITED STATES CUSTOMS
SERVICE. DEPARTMENT OF THE
TREASURY
[T.O. 75-194]
PART 12—SPECIAL CLASSES OF
MERCHANDISE
Imported Pesticides and Devices
On Jane 28; 1974, a notice of proposed
rulemaklng was published In the FEDERAL
RULES AND REGULATIONS
RZGBTEB (39 FR 24018) which proposed
to amend Part 13 of the Customs Regu-
lations (19 CFR Part 12) to set forth
regulations for the control of Imported
pesticides and devices. It was also pro-
posed to mate certain other conforming
changes In Part 12 of the Customs Regu-
lations to reflect the Inclusion of the pro-
posed regulations In that part.
After consideration of all the 'com-
ments received. It has been determined
that, with two exceptions, the amend-
ments should be adopted as set forth in
the notice of proposed rulemaklng. Pro-
posed section 12.113 has-been changed
to -provide that the Notice of Arrival
completed by the Administrator of the
Environmental Protection Agency and
Indicating Customs action to be taken
with respect to a shipment shall be pre-
sented to the district director of Customs
at the port of entry rather than at the
port of arrival. In addition, proposed
section 12.117(b) has been rewritten to
provide that the consignee of a ship-
ment of. pesticides and devices which
- has been found to'be In violation of the
Federal Insecticide. Fungicide, and Ro-
denticlde Act, as amended, shall be no-
tified promptly by the Administrator of,
the Environmental Protection Agency of
the nature of the violation and be given
a reasonable time, not to exceedJH) days.
to submit written material .or. at hto
option, to appear before" theAdminis-
trator and Introduce testimony, to show
cause why the shipment should not be
destroyed or refused entry.
The proposed amendments, Including
these changes, are adopted as set forth
below.
Effective date. These amendments
I shall become effective September 2,1975.
VeRBOif D. ACHEE,
Commissioner of Customs.
Approved: July 24,1975.
DAVIS R. MACDONALD,
Assistant Secretary oj the
Treasury.
I. Paragraph (b) of i 12.1 is amended
to read as follows:
8 12.1 Cooperation with certain agen-
cies; joint regulations.
• • • • •
(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. 138o(c)>, and regu-
lations Issued under the authority of
section 17(e) of that Act (7 U.S.C. 136o
(e)) by the Secretary of the Treasury,
In consultation with the Administrator
of the Environmental Protection Agency,
as set forth below (512.110 et s«r.).
§ 12.2 [Deleted]
2. Part 12 of the Customs Regulations
Is amended by deleting i 12.2.
3. Section 12.3 is amended to read as
follows:
32321
§12.3 Release under bond.
No food, drug, device, cosmetic, pesti-
cide, hazardous substance, or dangerous
caustic or corrosive substance, the sub-
ject of i 12.1 shall be released except in
accordance with the laws and regulations
applicable thereto. Where any such mer-
chandise is to be released under bond
pursuant to regulations applicable
thereto, a bond on Customs Form 7551,
7553, or 7595, containing a condition for
the re turn-of the merchandise, or any
part thereof, to Customs custody upon
demand of the district director of Cus-
toms, shall be required.
4. Part 12 of the Customs Regulations
is amended by adding 15 12.110-12.117
under the center heading "Pesticides and
Devices".
Pxsncmu AND DEVICES
See.
12.110 Definitions.
12.111 Beginratlon.
12.112 Notice of arrt> >estlcldes ana
dencee.
12.113 Arrtnl of .thlpment.
12.114 BteMM or ntaaal of delivery.
13 J15 riahmss under bond.
12.11* Samples.
'12.117 Itooadura cfter examination.
AUTUuari: RjB. in. aa amended 19 UJB.C
M: sec- ITU). Federal Insecticide. Fungicide,
and Ro»»»ttciae Act, aa amended tj tne
Federal famronmental PaatlcM* Control
Act of I9T3; Pub. L. B2-&*T (7 U.8JO.-136O
PESTICIBIB AND DEVICES
§ 12.110 Definitions.
Except as otherwise provided below,
the terms used in il 12.111 through
12.117 shall have the meanings set forth
for those terms In the Federal Insecti-
cide, Fungicide, and Rodenticide Act, aa
amended (7 U.S.C. 138 et sen.), herein-
after referred to as "the Act." The term
"Administrator" shall mean the Admin-
istrator of the Environmental Pro tec-
tton Agency.
§ 12.111 Registration.
An Imported pesticides are required to
be registered under the provisions of sec-
tion 3 of the Act, and under the regula-
tions (40 CFR 162.10) promulgated
thereunder by the Administrator before
being permitted entry- into the United
State*. Device*, although not required to
be registered, must not bear any state-
ment, design, or graphic representation
that is false or misleading In any partic-
ular.
§ 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 Ad-
ministrator a Notice of Arrival of
Pesticides and Devices (Environmental'
Protection Agency Form 3540-1), here-
inafter referred to as a Notice of Ar-
rival, prior to the arrival of the ship-
ment in the United States. The Admin-
istrator shall complete tbe Notice of
Arrival, indicating the dlapodtion to..W
made of the shipment of pesticide* or
devices upon its arrival in the United
States, and shall return the completed
FEDERAL REGISTER, voi. 40, NO. 149—FRIDAY, AUGUST i, 1975
Pesticides Inspection Manual
15-13
January 1989
-------
Chapter Fifteen
Exhibit 15-3
32322
Notice of ArriTBl to the Importer or his
agent.
Chemfcolt tagorteA /or uu otter
ttun «r pesthMei. Chtartr ill which on
be used a* pesticides bat whlcb are not
Imported for each uae and are not
shown en the Abbreviated Ltot of Pes-
ticides T"-f by the Bnvironmental
ProteeUon Agency. may be entered with-
out the iQbntisslon of the Notice of Ar-
rivaL
§12.113 Arrival of shipment."
(a) Notice o/ arrival presented. Upon
the arrival of a shipment of pesticides
or devices, the Importer or his agent
shall present to the district director of
Customs at the port of entry the Notice
of Arrival completed by the Adminis-
trator and Indicating the Customs action
to be taken with respect to the shipment.
The district director shall compare entry
documents for the shipment of pesticides
or devices with the Notice of Arrival and
notify the Administrator of any dis-
crepancies.
(b) Notice o/ arrival not presented
When a shipment of pesticides or de-
vices arrives In the United States with-
out the presentation by the Importer or
his agent «f the Notice of Arrival com-
pleted by toe Administrator, the ship-
ment shall be detained by the district
director at the Importer's risk and ex-
pense until the completed Notice of
Arrival Is presented or until other dis-
position is ordered by the Administra-
tor, but not to exceed a period of 30
days, or siifh extended period, not In
excess of 3ft additional days, as the dls-
'.rlct director for good cause may spe-
cially authorize. Ao application, of. the
importer or his agent requesting an ex-
tension of the Initial 30-day period shall
be filed with the district director at the
port of entry.
DiffoMio* of pesticides or de-
vices remaining under detention. A ship-
ment that remains detained or undls-'
posed of due to failure of presentment
of a completed Notice of Arrival or
nor; receipt of an order Ot the Adminis-
trator a* to its disposition shall be
treated as a prohibited Importation. The
district director shall cause the destruc-
tion oX any "**** shipment not exported
by the consignee within «0 days 'after
the expiration of the detention period
specified or authorized pennant to
5
§ 12.114 Release or refusal of deliver}'.
ii the completed Notice ol- Arrival
directs the district director of Customs
to release the shipment of pesticide* or
devices, the shipment snaO be released
to* the consignee. ZT trie completed Notice'
of Arrival directs the district director
to refuse delivery of the shipment, the
shipment shall be refused delivery and
treated as' a prohibited Importation. The
district director shall cause the destruc-
tion of any shipment refused delivery
and not exported by the consignee wttlda
9fr days1 after notice of aucli icfusal of
delivery.
RULES AND REGULATIONS
§12.115 Release under bond.
If the completed Notice of Arrival so
directs, a shipment of pesticide* or de-
vices shall be detained at the importer'*
expense by the district director of Cus-
toms pending an examination by the Ad-
ministrator to determine whether the
shipment complies with the requlrtn^nta
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 fur-
nished on Customs Form 7SS1, 7553, or
7595 for the return of the merchandise
to Customs custody. The bond shall be
In the amount required under } 113.14
of this chapter. When a shipment of pes-
ticides or devices is released to the.
consignee under bond, the shipment shall
not be used or otherwise disposed of
until the determination Is made b; the
damages In the full «""«""* of the bond.
The district director shall eaua* the de-
struction of any merchaodto re*w4
denvery to the consignee, or redelrrcM*
by the consignee pursuant te a- dMMtf
therefor, and not exported by the
slgnee wlthta 90 days alter notice of
such refusal of delivery or within 90
days after such redellvery. to. applicable.
(R.S. 251, aa amended, MO. 834 -MS 8ft*. IN
(1B0.8.C. 66, 16J4))
IFR Doc.78-30081 mad 7-31- ..,«:««••]•
g 1X116
Upon the request of the Administra-
tor, either on the completed Notice of
Arrival or otherwise, the district director
of Customs shan deliver to the Ad-
ministrator samples of the Imported
pesticides or'devices, together with all
accompanying labels, circulars, and ad-
vertising matter pertaining to such mer-
chandise. The district director shall
notify the consignee, In writing, that the
samples of Imported pesticides or devices*
together with all accompanying labels.
circulars, and advertising matter per-
taining to such merchandise have been
delivered to the Administrator.
§12.117 Procedure after examination
(a> Merchandise complying wtth the
Art. 11, upon examination or analysis
of a sample from a shipment of pesti-
cides or devices, the sample Is found to
be in compliance with the Act,'the Ad-
ministrator, shall notify the district di-
rector of Customs 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 to found to be In
violation of the Act, the consignee shall
be notified promptly by the Administra-
tor of the nature of the violation and be
given a reasonable time, not to exceed 20
days, to submit written material or, at
his option, to appear before the Admin-
istrator and introduce testimony,, to show
cause why the shipment should no* be
destroyed or refused entry. If, after con-
sideration of all the evidence presented.
It is still QIC opinion of the Adminlstratosr
that the merchandise Is In violation of
the Act, the Administrator shall notify
the dttrfct director of this opinion and
the district director shall either (1) re-
fuse delivery to the consignee, or (21 H
the shipment has been released to ttM
consignee under bond, demand redeliverj
of the shipment under the terms of the
bond. If the merchandise Is not rede-
livered within 30 days after the date of
demand by the district director, the
district director shall assess liquidated
ftDEIAl REGISTO, VOL 40, NO. 149—fRIDAY, AUGUST 1, 1975
Pesticides Inspection Manual
15-14
January 1989
-------
Disposal
-------
Chapter Sixteen
DISPOSAL
[Text to Follow in Future Draft]
Pesticides Inspection Manual 16-i January 1989
-------
Chapter Sixteen Disposal
Pesticides Inspection Manual 16-n January 1989
-------
Warrants
-------
Chapter Seventeen
WARRANTS
Page No.
AUTHORITY 1
OBJECTIVE 1
POLICY 1
In General 1
Impact of Barlow's Decision on Conduct of FIFRA Inspections 2
PROCEDURES 2
Obtaining the Warrant 2
Contact the U.S. Attorney 3
Requirements for Obtaining a Warrant 3
Executing the Warrant 4
Introduction 4
Denial of Entry 4
Inspecting With a Warrant 4
Returning the Warrant 5
Challenges to the Warrant 5
Exhibit 17-1: Conduct of Inspections After the Barlow's Decision 7
Exhibit 17-2: Model Affidavit in Support of Application for a Warrant 17
Exhibit 17-3: Model Warrant 19
Pesticides Inspection Manual 17-i January 1989
-------
Chapter Seventeen Warrants
Pesticides Inspection Manual 17-ii January 1989
-------
Chapter Seventeen
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:
o Entry for the purposes of Section 9(b);
o 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 the establishment
[which has been found to be adulterated, misbranded, not registered (in the case of a
pesticide), or otherwise in violation of FIFRA] 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
o 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 inspector should 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 should prepare detailed notes
giving the name of the person approached, his/her title, time of denial, reason for denial (if given),
Pesticides Inspection Manual 17-1 January 1989
-------
Chapter Seventeen Warrants
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, thus, 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 should 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 17-1.) All inspectors should carefully review and become
thoroughly familiar with this guidance, including the specific requirements regarding criminal
warrants (which are not repeated in this Chapter). The inspector should also review and become
familiar with the warrants section of the legal module of the EPA "Basic Training Program for Field
Inspector Personnel".
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.
Pesticides Inspection Manual 17-2 January 1989
-------
Chapter Seventeen Warrants
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 should contact the U.S. attorney of
the district in which the property is located. The regional office should 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) one or more accompanying affidavits, and (3) 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. Exhibit 17-2 is an example of an affidavit that can be used to support an application for a
warrant. Exhibit 17-3 is an example of a warrant that may be prepared for the magistrate's signature.
The application for a warrant should 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 can be only one page 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 Assistant U.S. Attorney.
The affidavits in support of the warrant application are crucial. Each affidavit should 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 should recite
or incorporate by reference the neutral administrative scheme that is the basis for inspecting the
particular establishment. Each affidavit should 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 samples 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 should 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 should
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).
Pesticides Inspection Manual 17-3 January 1989
-------
Chapter Seventeen Warrants
Executing the Warrant
Introduction
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 than 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 should be accompanied by a U.S. Marshall when
executing the warrant. For reasons of personal safety, the inspector should not attempt forcible entry
of the facility at his/her own initiative.
If the facility representative refuses entry to an inspector holding a warrant but not
accompanied by a U.S. Marshal, the inspector should 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 should 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 should 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.
Inspectors should keep the following points in mind when conducting an inspection pursuant to
a warrant:
o Follow the "seize now and worry about the propriety later" doctrine. In other words, 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.
o Pay particular attention to obtaining evidence regarding authorship, possession, and
distribution of facility documents.
Pesticides Inspection Manual 17-4 January 1989
-------
Chapter Seventeen Warrants
o Apply the "plain view" doctrine, which means essentially that if a piece of evidence is where
it can be seen by anyone in a lawful position or place to do so, it can be collected.
o 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.
o 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.
o 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.
o The Agency interprets FIFRA as authorizing EPA to physically remove documents from
the establishment and carry them away, and the magistrate should 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 should 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:
o Insufficient cause for issuance of the warrant;
o Insufficient affidavit supporting the warrant;
Pesticides Inspection Manual 17-5 January 1989
-------
Chapter Seventeen Warrants
o Inaccurate information in the supporting affidavit;
o Insufficient description of the premises or items to be seized;
o Searches beyond the scope of the warrant; and
o Failure to follow appropriate procedures for serving or returning the warrant.
For a warrant or 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 inspections.
Pesticides Inspection Manual 17-6 January 1989
-------
Chapter Seventeen Exhibit 17-1
Conduct of Inspections After the Barlow's Decision
uNi .'tu SVATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
TO: Regional Administrators
Surveillance and Analysis Division Director*
Enforcement Division Directors
FROM: Assistant Administrator
for enforcement
SUBJECT: Conduct of Inspections After the Barlow's Decision
I. Sunroary
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 wrrants or other process for
inspections pursuant to EPA-administered Acts.
In Barlow's, the Supreme Court held that an CSHA 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 haw a limited effect on EPA
enforcement inspections:
o Inspections will generally continue as usual)
o tfcere an inspector is refused entry, EPA win seek a warrant through
the O.S. Attorney;
o 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 tfcere entry is denied, were largely in accord with
the provisions of Barlow's before the Supreme Court issued its ruling.
Nevertheless, a number of 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 docu-
it*
Pesticide Inspection Manual 17-7 January 1989
-------
Chapter Seventeen Exhibit 17-1
- 2 -
This document focuses on the preparation £or and conduct of inspec-
tions, including (1) how to proceed when entry is denied, (2) under what
circumstances a warrant is necessary, and (3) what showing is neces-
sary 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 nay
wish to obtain a warrant to conduct an inspection even before there has
been any refusal to allow entry. Such a warrant nay be necessary when
surprise is particularly crucial to the inspection, or when a company's
prior bad conduct and prior refusals mate it likely that warrantless
entry will be refused. Pre-inspection warrants nay also be obtained where
the distance to a U.S. Attorney or a magistrate is considerable so that
excessive travel tine 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 nay be sought more frequently, (far specific instructions on
how to obtain a warrant, see Part 0.)
(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 natter, and to know when it is necessary to secure a
criminal rather than • 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, nonconpliance with regulatory
requirements, an administrative inspection (civil) warrant nay 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
oust be obtained under Role 41 of the Federal Riles of Criminal Procedure;
and (3) evidence obtained during a valid civil inspection is generally
admissible in criminal proceedings. These principles arise fron 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 National Bank,
O.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 or •administrative" warrant, but we believe that
Pesticide Inspection Manual 17-8 January 1989
-------
Chapter Seventeen Exhibit 17-1
- 3 -
a civil warrant can properly be used unless the intention is clearly to
conduct a criminal investigation.
(3) Tn<» Use oS Contractors to Conduct Inspections
Several piojrams 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 con-
tractors 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 inspec-
tors 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 con-
cerning compliance with Barlow^ arise.
With regard to specific procedures for States to follow, the
important paints to remember are: (1) The State should not seek for-
cible 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 procredures 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 denial!! 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 inspec-
tion framework will thus not be severely disrupted. Consequently, inspec-
Pesticide Inspection Manual 17-9 January 1989
-------
Chapter Seventeen Exhibit 17-1
- 4 -
tions 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 hut, in an attempt to gain admittance, will
present his credentials and issue a notice of inspection where required.
The establishment owner nay 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
charqe 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 the 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
proceed iig.
(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
sanples 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. 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
1
FIFRA inspections are arguably not subject to this aspect of Barlow's
See discussion, p. 5 and 6.
Pesticide Inspection Manual 17-10 January 1989
-------
Chapter Seventeen Exhibit 17-1
- 5 -
refused, the inspector should leave the premises immediately and telephone
the designated Regional Enforcement Attorney as aeon as possible for
further instructions, de 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 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.
Sarcples 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 send a copy of all papers filed to Headquarters. It is
necessary for Headquarters to nonitor refusals and Regional success in
obtaining warrants to evaluate the need for improved procedures and to
assess the impact of Barlow's on our ccxnpliance monitoring programs.
C. Areas Where a .Right of Warrantless Entry Still Exists
1. Emergency Situations.
In an emergency, where there is no tine to get a warrant, a warrant-
less inspection is permissible. In Camera y. Municipal tourt, 387 U.S. 523
(1967), the Supreme Court states that "nothing we say tooay is intended
to foreclose prorpt 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 judgment 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 tine necessary to secure that Marshal's
assistance.
An emergency situation would include potential tarainent 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 tine 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
Pesticide Inspection Manual 17-11 January 1989
-------
Chapter Seventeen Exhibit 17-1
- 6 -
of government regulation. An Agency administrative law judge held recently
that even after the B&rlov's decision, refusal to allow a warrantless
inspection of a FIFKA regulated establishment properly subjected the
owner to civil penalty. K. Jonas t Co., Inc., I.F. t R Docket ND. III-121C
(July 27, 1978). For the present, however, FIFRA inspections should be
conducted under the sane requirements applicable to other enforcement
programs.
(3) "Open Fields" and "In Plain View" situations.
Observation by inspectors of things that are in plain view, (_i.£.,
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 publiv; are admitsible. 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 O.S.
Attorney or by his Assistant U.S. Attorney.
The affidavits in support of the warrant application are crucial
documents. Each affidavit should consist of consecutively numbered para-
graphs, 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 kncvlege 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 by notarized or personally sworn to before the magistrate.
Pesticide Inspection Manual 17-12 January 1989
-------
Chapter Seventeen Exhibit 17-1
- 7 -
The warrant 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. Since the inspection is limited by the terms of
the (--arrant, it is important to specify to the broadest extent possible
the areas that are intended to be inspected, any records to be inspec-
ted, 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 dr;:ft -wan-rant 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 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 eaus* 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 been
committed, a warrant nay 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;
Pesticide Inspection Manual 17-13 January 1989
-------
Chapter Seventeen Exhibit 17-1
- 8 -
•Probable cause in the criminal law sense is not required. '
For purposes of an administrative search, such as this, probable
cause justifying the issuance of a warrant nay 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 speci-
fic business has been chosen for an OSEA search on the basis of a
general administrative plan for the enlbrcenent 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. Far example, a scheme under thich 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 satis-
factory, as long as, neutral criteria such as random selection are used to
select the 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 cause 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 XX and XXX)
Die Assistant D.S. Attorney will request the inspector to prepare and
sign an affidavit that states the facts as he knows then, The statement
should include the sequence of events culminating in the refusal to allow
entry and a recitation of either the specific probable ciuse or the
neutral administrative scheme which led to the particular establishment's
selection for inspection. The Assistant D.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 D.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. She
2
The 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
Pesticide Inspection Manual 17-14 January 1989
-------
Chapter Seventeen Exhibit 17-1
distinction between administrative inspections and criminal warrant
situations is discussed in Section ZI.A.2.
F. Inspecting with a Warrant
Once the warrant has been issued by th4 magistrate or judge, the
inspector may proceed to the establishment to comence 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. Marsha,!, when 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 U.S. Attorney and the designated Regional Attorney. They will
take appropriate action such as seeking a citation for contempt. Vbere
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, or 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 air,'thing iiaken from the premises. This inventory will be
examined by the magistrate to assure that the warrant's authority has
not been exceeded.
2 continued from page 8.
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. Vte 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 appro-
priate 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 expeditious than the seeking of an injunction, any decision to
seek such an injunction for inspection purposes should be cleared through
appropriate Headquarters staff.
Pesticide Inspection Manual 17-15 January 1989
-------
Chapter Seventeen Exhibit 17-1
- 10 -
G. Returning the Warrant.
After the inspection has been oonpleted, the warrant oust be returned
to the magistrate. Whoever executes the warrant, (i.e., whoever performs
the inspection), must sign the return of service form indicating to whan
the warrant was served and the date of service. Be 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 itens
oust be submitted to the court, and the inspector oust 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 how to proceed in any entry case,
do not hesitate to call the respective Headquarters program contact for
assistance.
/
Marvin B. Durning
Pesticide Inspection Manual 17-16 January 1989
-------
Chapter Seventeen Exhibit 17-2
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. §136 ej
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 is sought under Section 9 of the Federal Insecticide, Fungicide, and
Rodenticide Act, as amended, (7 U.S.C. § 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 authorizirig-
"(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 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) the seizure of any pesticide or device which is in violation of this Act."
Pesticide Inspection Manual 17-17 January 1989
-------
Chapter Seventeen Exhibit 17-2
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 warrante 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 •
Pesticide Inspection Manual 17-18 January 1989
-------
Chapter Seventeen Exhibit 17-3
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.
§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 placed
(Address)
-or-
Application having being made and probable cause shown, by (Name of Officer), for
inspection or sampling of pesticides used in violation of the said Act, at the place described
as:
(Name of person or property Owner)
(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. Barlow's Inc.. 436 U.S. 307 (1978) you are authorized
to enter (immediately) the 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.
Pesticide Inspection Manual 17-19 January 1989
-------
Chapter Seventeen Exhibit 17-3
Model Warrant
RETURN OF SERVICE
I hereby certify that a copy of the within warrant was served by presenting a copy of same
to (facility owner or 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)
Pesticide Inspection Manual 17-20 January 1989
-------
Safety
-------
Chapter Eighteen
SAFETY
Page No.
OBJECTIVE 1
RESPONSIBILITIES 1
Headquarters 1
Regional Offices 1
Employees 1
SAFETY EQUIPMENT 1
SAFE HANDLING OF PESTICIDES 3
General Safety Guidelines 3
Specific Safety Guidelines 3
Inhalation 3
Skin Absorption 4
Ingestion 4
Eye Contact 5
EMERGENCY TREATMENT 5
Skin Exposure 5
Ingestion 6
Eye Contact 6
RECOMMENDED SAFETY EQUIPMENT FOR INSPECTIONAL AND SAMPLING
ACTIVITIES 6
Use Inspection — Mixing and Loading Observation 6
Use Inspection -- Application Observation 6
Collecting Environmental Samples 6
Sampling Pesticides and Producer, Distributor, or Marketplace
Establishments 7
Pesticides Inspection Manual 18-i January 1989
-------
Chapter Eighteen Safety
Pesticides Inspection Manual 18-ii January 1989
-------
Chapter Eighteen
SAFETY
OBJECTIVE
This section is intended to protect persons who handle pesticides by ensuring the use of proper
safety equipment and proper working habits.
RESPONSIBILITIES
Headquarters
EPA Headquarters must provide the regional offices with the guidance and requirements
necessary for them to comply with all Federal safety standards.
Regional Offices
The regional office must provide adequate training, guidance, and equipment to protect the
safety of persons handling pesticides.
Employees
Each employee has the following responsibilities:
o To be familiar with all safety requirements and practices;
o To maintain safety equipment in good condition and proper working order; and
o To use safety equipment in accordance with established requirements and instructions.
SAFETY EQUIPMENT
The inspector should follow label safety instructions when handling pesticides. Safety
equipment include, but is not limited to, the following:
o Safety glasses (prescription if required), goggles, or face shield;
o Protective Footwear in the form of rubber-soled, non-skid, metal-toed shoes and plastic
disposable shoe covers, or rubber/neoprene boots.
Pesticides Inspection Manual 18-1 January 1989
-------
Chapter Eighteen Safety
o Gloves that are liquid proof and made of natural or synthetic rubber, or throw away
plastic and should be long enough to protect the wrist;
o Coveralls made of closely woven fabric and spill- resistant;
o Long rubber apron;
o Hard hat made of plastic with a plastic sweatband;
o Respiratory Protective Devices: Different types of cartridges and canisters must be
used to protect against different chemical gases and vapors. Be sure to use the one made
for the pesticide that is being sampled, and follow the label instructions on the respiratory
protection device. In all cases the respiratory equipment used shall be of the type
approved by either the National Institute of Occupational Safety and Health (NIOSH) or
the Mining Enforcement and Safety Administration (U.S. Bureau of Mines).
Chemical cartridge respirator. This type of respirator covers the nose and mouth.
(Some are available with goggles to protect eyes; if not, goggles should be worn as
well.) The inhaled air comes through both a filter pad and a cartridge made to absorb
pesticide vapors and remove most harmful vapors, gases, and particles.
Chemical canister respirator. This type of canister usually covers more of the face
than the cartridge respirator and has longer lasting absorbent material and filters.
Neither type of respirator is to be used for protection during fumigation or when the
oxygen supply is low (such as in silos).
Self-Contained Breathing Apparatus (SCBA^). The SCBA, whether cartridge or
canister, must fit the face snugly. A beard, heavy sideburns, or glasses may prevent a
good seal. Cartridges or cartridge filter units should be changed every 4 hours;
canisters should be changed every 8 hours. Both types should be changed more often
if needed. After each use, wash the face piece in detergent and water, rinse, dry, and
store in a clean, dry place away from the pesticide that was sampled.
The following additional safety equipment should be kept in the inspector's car for use as
necessary or appropriate:
o First aid kit;
o Fire extinguisher;
o Airtight containers for storing highly toxic and corrosive samples;
o Soap or waterless hand cleanser and towels;
o Supply of clean water for washing in case of an accident; and
o Emergency eye wash kit.
Pesticides Inspection Manual 18-2 January 1989
-------
Chapter Eighteen Safety
SAFE HANDLING OF PESTICIDES
General Safety Guidelines
The following guidelines should be followed when handling or sampling pesticides:
o Read the label and, as a minimum, follow the handling instructions for mixing and loading.
o Use only proper tools for opening containers and be careful when opening and reclosing
containers.
o Open and sample pesticides in areas where spills can be cleaned up easily and properly.
o If chemicals are spilled on clothing, remove the clothing immediately and wash the skin
thoroughly. Always keep a change of clothes on hand for such emergencies.
o Wash hands immediately after sampling.
o Do not use your mouth to siphon or put: your hands near your mouth and eyes during
sampling operations.
o A supply of detergent soap, clean water, and waterless hand cleanser should be readily
available.
o Know the limitations of the protective equipment being used, especially respirators.
o Have the phone numbers of local hospitals, doctors, or poison control centers available.
Specific Safety Guidelines
Before sampling any pesticide, the inspector should read the precautionary statements on the
label to determine whether the pesticide is toxic through dermal absorption, inhalation, or ingestion.
(Some may be injurious through all three routes.) After determining what routes of exposure to avoid
for the pesticide being sampled, use the proper equipment for protection in handling that pesticide.
Always be careful when collecting samples regardless of the declared toxicity of the pesticide because
the product may be mislabeled or improperly formulated and thus would be misleading regarding its
true toxic nature.
Always be alert for such hazards as spilled materials, materials that are improperly stacked,
moving equipment (such as f orklif ts and conveyor belts), poor ventilation, and bad lighting.
The following information will provide some insight into the manner by which harmful sub-
stances may enter the body.
Inhalation
Breathing gas, vapor, mist, fumes, or dust is the most common accidental form of exposure.
This route of entry is the most likely cause of systemic illness. The inhalation hazard depends on a
number of factors: (1) the likelihood of the chemical escaping to the air; (2) the concentration pres-
ent in the air; (3) the volatility of the chemical at a given temperature; (4) the inherent toxicity of the
chemical; and (4) the length of time the chemical is inhaled.
Pesticides Inspection Manual 18-3 January 1989
-------
Chapter Eighteen Safety
Inhaling fumes from certain chemicals may result in two distinct reactions. First, it may affect
the lining of the air passages of the nose, throat, and lungs, usually causing irritation and mild burns.
Second, it may be absorbed by the lungs into the bloodstream and distributed throughout the body
causing a systemic injury.
The inspector should use the following precautions when obtaining samples from bulk con-
tainers of pesticides having an inhalation hazard:
o Read the label;
o Sample in well-ventilated area;
o Use a respirator;
o Wear protective clothing, including goggles or face shield and gloves as appropriate;
o Keep samples well marked and seal as soon as possible;
o Wash exposed skin areas with soap and water; and
o Transport and store samples in accordance with established procedures.
Skin Absorption
Certain chemicals are able to penetrate the unbroken skin and are picked up by the blood-
stream and distributed throughout the body. Skin penetration is probably the second most common
accidental means of entry of chemicals into the body. The following precautions should be used when
collecting samples from bulk containers of pesticides that may be hazardous by skin contact:
o Read the label;
o Wear protective clothing, including goggles or face shield, and gloves as appropriate;
o If clothing becomes contaminated, remove at once and wash skin. (Contaminated clothing
should not be worn again until it has been decontaminated in accordance with established
procedures);
o Wash exposed skin areas with plenty of soap and water;
o Keep samples well marked and seal as soon as possible; and
o Transport and store samples in accordance with established procedures.
Ingestion
Toxic amounts of the pesticide may be carried to the mouth by the hand when drinking, eating,
or smoking. Therefore, don't eat, drink, or smoke when sampling. Liquids should not be pipetted
by mouth under any circumstances.
The following precautions should be observed in collecting samples of pesticides, particularly
when sampling from bulk containers:
Pesticides Inspection Manual 18-4 January 1989
-------
Chapter Eighteen Safety
o Read the label;
o Wear protective clothing, including gloves as required or appropriate;
o Do not eat, drink, smoke or put anything in the mouth when sampling;
o Wash exposed skin areas with soap and water after sampling;
o Keep samples well identified and seal as soon as possible; and
o Store and transport samples in accordance with established procedures.
Eye Contact
The eyes may be harmed by chemicals in either the liquid or vapor form. Irritant effects vary in
degree from mild to severe. Most chemicals have the ability to injure the eye to some degree follow-
ing surface contact. Take the following precautions to avoid eye injury when collecting samples from
bulk containers:
o Read the label;
o Wear goggles or face shield as required or appropriate;
o Wash exposed skin areas thoroughly after sampling;
o Do not rub eyes when sampling; and
o Store and transport samples in accordance with established procedures.
EMERGENCY TREATMENT
Emergency treatment is necessary not only to obtain immediate relief, but to prevent further
damage from the poisoning until professional medical help arrives. In the case of pesticide poisoning
this is accomplished in three ways: removing, diluting, or slowing the movement of the poison.
Knowledge of the characteristics of the poison, combined with prompt treatment, is essential in
reducing the extent of the injury. Label instructions, when available, should be followed when admin-
istering first aid.
Skin Exposure
1. Wash the skin with copious amounts of soap and water.
2. If clothing is contaminated, remove it immediately and wash the skin thoroughly with
running water.
3. Shower immediately, if there is one available, and remove your clothing while showering.
(This procedure may be life-saving, as certain highly toxic chemicals are rapidly absorbed
through the skin.)
5. All contaminated parts of the body, including hair, should be thoroughly decontaminated.
It may be necessary to wash repeatedly.
Pesticides Inspection Manual 18-5 January 1989
-------
Chapter Eighteen Safety
6. If alcohol is available, it should be used to wash all affected areas, except the eyes.
Ingestion
1. Vomiting should be induced unless an aspiration hazard, such as from a petroleum prod-
uct, is a predominant factor. An emetic should be taken, if the toxicant is not corrosive, or
if the aspiration hazard is less than the systemic hazard. A tablespoon of salt or powdered
mustard in a glass of warm water can be taken as an emetic. Refer to label for specific
instructions.
2. Drink plenty of water and place a finger down the throat if necessary to induce vomiting.
The treatment should be repeated until vomitus is clear.
Eye Contact
1. Wash eyes with plenty of water. The eye itself should be held open and flooded with water
so that all surfaces are washed thoroughly. Washing should be continued for 15 minutes.
2. Medical attention should be obtained immediately.
RECOMMENDED SAFETY EQUIPMENT FOR INSPECTIONAL AND SAMPLING
ACTIVITIES
Use Inspection — Mixing and Loading Observation
1. Safety glasses or face shield
2. Respiratory protective device
3. Protective footwear
4. Coveralls or long-sleeve shirt
5. Hat
Use Inspection -- Application Observation
1. Safety glasses or face shield
2. Respiratory protective device
3. Protective footwear
4. Coveralls or long-sleeve shirt
5. Hat
Collecting Environmental Samples
1. Safety glasses
2. Protective footwear
3. Gloves
4. Respiratory protective device (depends on suspected pesticide)
5. Coveralls
6. Hat
Pesticides Inspection Manual 18-6 January 1989
-------
Chapter Eighteen Safety
Sampling Pesticides and Producer, Distributor, or Marketplace Establishments
1. Hard hat
2. Safety glasses
3. Protective footwear
4. Respiratory protective device when sampling from a larger size unit
5. Coveralls or long rubber apron when sampling from a larger size unit
6. Gloves when sampling from a larger size unit or handling highly toxic pesticides
7. Sampling from larger size units should be done in lighted, well-ventilated areas
Pesticides Inspection Manual 18-7 January 1989
-------
Chapter Eighteen Safety
Pesticides Inspection Manual 18-8 January 1989
-------
Appearing As A Witness
-------
Chapter Nineteen
APPEARING AS A WITNESS
Page No.
OBJECTIVE 1
PREHEARING PREPARATION AND PERSONAL APPEARANCE 1
GENERAL CONDUCT IN COURTROOM AND VICINITY 2
PROPER TECHNIQUE ON THE WITNESS STAND 2
THE DIRECT EXAMINATION 3
Laying the Foundation For Your Testimony . 3
Your Testimony 3
CROSS EXAMINATION 4
PROPER CONDUCT AFTER TRIAL 5
EXPERT WITNESS 5
Pesticides Inspection Manual 19-i January 1989
-------
Chapter Nineteen Appearing as a Witness
Pesticides Inspection Manual 19-u January 1989
-------
Chapter Nineteen
APPEARING AS A WITNESS
OBJECTIVE
To assist the EPA witness in presenting an informative, comprehensive, and creditable
testimony in civil and criminal proceedings brought under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) or other Federal criminal statute. These proceedings may be
administrative (before an EPA Administrative Law Judge) or judicial (before a Federal Court judge).
PREHEARING PREPARATION AND PERSONAL APPEARANCE
A well-groomed, neatly attired witness makes a more favorable impression in the courtroom.
o Prehearing preparation begins when the facility is assigned to you. If the case goes to an
administrative hearing, the 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.
o The EPA attorney assigned to the case will want to know everything you know before the
hearing begins. If you have not heard from the attorney a month before the hearing is
scheduled, call him/her. Ask what he/she intends to prove by your testimony.
o Go over your files, copy everything you think will help prove the government's case and
send it to the attorney. Make sure your file is complete. If there are problems, with the
case, let the attorney know. If the case is weak, the attorney will not want to find that out
at trial.
o Clear your calendar for the days you will be needed as a witness.
o Arrange to meet with the attorney before the hearing date and have him/her go over your
testimony. You may give the attorney valuable information he/she does not know EPA
has.
o Ask questions now. It will be too late to find out what you are supposed to do once the
hearing begins.
Gentlemen should wear jackets and ties; women should wear skirts. Courts are one of the last
bastions of traditional, conservative dress.
Pesticides Inspection Manual 19-1 January 1989
-------
Chapter Nineteen Appearing as a Witness
GENERAL CONDUCT IN COURTROOM AND VICINITY
o Your conduct should reflect the solemn nature of the administrative/judicial proceedings.
o Do not discuss the case with anyone not a part of the EPA team and then only when you
are where no one else can overhear.
o Do not whisper or talk to another person, or cause any disturbances in the courtroom.
o Do not talk to the jurors or discuss the case within their hearing.
o 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.
o Do not bring magazines or newspapers into the courtroom.
o Show no incredulity or surprise at any testimony given from the witness stand or at
statements made by the defense attorney.
o Be on time when court opens and be available immediately when called to testify.
o Listen to the testimony of others. It may trigger a memory or an interpretation you had not
thought of.
o 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.
o After your testimony, do not leave the courtroom unless you have made sure you will not
be recalled to the stand or that you are no longer needed.
PROPER TECHNIQUE ON THE WITNESS STAND
o 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.
o 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.
o 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/mam" and "no sir/mam."
Speak clearly and distinctly.
Look at and speak to the jury. Speak plainly enough so that the farthest juror will hear
you.
Pesticides Inspection Manual 19-2 January 1989
-------
Chapter Nineteen Appearing as a Witness
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.
Do not show hostility toward the defendant or the opposing counsel. You can lose a
case for the government by losing your temper. You should be objective and
professional.
If you need to use acronyms or technical terms, make sure you explain what they
mean. You should 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 your rnouth, face, and head.
Attempt to minimize nervous tendencies, such as arranging clothes, tie, etc.
THE DIRECT EXAMINATION
Direct examination is done by the government attorney asking you questions. The following
guidelines are applicable to both direct and re-direct examination. You should 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
o The first questions you will be asked are to identify you for the judge. You will be asked
about your job and your qualifications to do whatever you will testify you did for this case.
o 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.
o Questions usually begin broad and move to the more specific. Listen to what you are being
asked.
Your Testimony
o Always tell the truth.
o Answer only the question asked. Do not volunteer additional information.
Pesticides Inspection Manual 19-3 January 1989
-------
Chapter Nineteen Appearing as a Witness
o 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 should never be used to be evasive. You may be
qualitifed as an "expert witness" but this does not mean you are infallible; you can only
answer the questions to the best of your ability.
o Do not give personal opinions.
o Do not be hesitant about using your contemporaneous notes to refresh your memory and
you should do so in cases of complicated figures, dates, etc.
o If you do refresh your memory from notes, the defense has the right to examine them and
make them an exhibit in the case.
o 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.
o The instructions regarding your testimony (listed previously under "Direct Examination")
are equally important when testifying under cross examination.
o Under cross examination, you will likely be subjected to more vigorous questioning than
you were under direct examination.
o 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 the other attorney succeed at this attempt.
o 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 creditability.
o If the cross examiner attempts to confuse you with rapid questions you should:
Answer him/her deliberately and at a comfortable pace.
Ask him/her to repeat or restate any unclear or confusing question.
o Do not attempt to be argumentative with the cross examiner if he/she interrupts your
testimony. The U.S. or EPA Attorney should 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.
o The cross examiner may ask a double or two-pronged question. Ask him/her to restate it
or carefully answer each part separately.
o 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
Pesticides Inspection Manual 19^4 January 1989
-------
Chapter Nineteen Appearing as a Witness
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.
o If the cross-examiner should misquote any of your earlier testimony when asking a
question, you may correct the misquote before answering the question.
o 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, discuss the matter
with the government attorney. If you are caught in an error, admit it and explain it if
possible.
o Do not draw legal conclusions of the innocence or guilt of the respondent, even if his/her
attorney asks you to do so.
PROPER CONDUCT AFTER TRIAL
o After the trial, continue to conduct yourself in a manner that will bring credit to you and
the Agency.
o If there is occasion to speak to the defendants, be courteous regardless of their demeanor.
However, do not discuss your testimony or the merits of the case with them even after the
hearing is over.
o 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 should raise and give them to him 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 has satisfied himself that you
have the requisite knowledge "not common to your fellow man." Often your experience is what
qualifies you as an expert.
Pesticides Inspection Manual 19-5 January 1989
-------
Chapter Nineteen Appearing as a Witness
Pesticides Inspection Manual 19-6 January 1989
-------
FIFRA Criminal Enforcement
-------
Chapter Twenty
FIFRA CRIMINAL ENFORCEMENT
Page No.
INTRODUCTION 1
THE CRIMINAL PROVISIONS OF FIFRA 1
THE STATE AND FEDERAL ROLES IN CRIMINAL ENFORCEMENT OF FIFRA 2
FIFRA'S RELATIONSHIP TO OTHER FEDERAL CRIMINAL LAWS 2
OVERVIEW OF CRIMINAL ENFORCEMENT 2
Special Attention To Defendant's Rights 2
Criminal Enforcement at EPA 3
RECOGNIZING POTENTIAL CRIMINAL VIOLATIONS 3
Criminal Enforcement Compared to Civil Enforcement 4
Searches 5
Compelling the Production of Information 5
Charging the Commission of a Crime 6
Discovery 6
Burden of Proof 6
Penalties 6
Criminal Investigations 7
Initiating an Investigation 7
Conducting an Investigation 7
Security of Criminal Investigations 8
Parallel Criminal and Civil Proceedings 8
Compliance with the Jencks Act 9
Participation in Grand Jury Investigation 9
CASE STUDIES 10
Pesticides Inspection Manual 20-i January 1989
-------
Chapter Twenty FIFRA Criminal Enforcement
Pesticides Inspection Manual 20-ii January 1989
-------
Chapter Twenty
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 Office of Criminal
Investigations. 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, DC). 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 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 should be alert to the fact that the commission of any of these unlawful acts may
potentially represent a criminal case.
Pesticides Inspection Manual 20-1 January 1989
-------
Chapter Twenty FIFRA Criminal Enforcement
THE STATE AND FEDERAL ROLES IN CRIMINAL ENFORCEMENT OF FIFRA
Sections 26 and 27 of FIFRA (7 U.S.C. Sections 136W-1 and 136W-2) provide that those states
having cooperative agreements with EPA have "primary enforcement responsibility for pesticide use
violations." 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.
Violations of an EPA stop sale or suspension order, fraudulent labeling, advertising, or
registration of a pesticide are among those types of FIFRA violations for which states do not have
primary enforcement authority. Even where there is a FIFRA pesticide use violation, the states can
choose to waive their primary enforcement responsibility to allow Federal criminal enforcement
action to be undertaken. Due to this shared nature of pesticide enforcement, there needs to be
effective Federal-state cooperation to achieve successful criminal enforcement of pesticide statutes
and regulations.
An excellent example of such beneficial cooperation concerned a 1987 pesticide use violation
that caused the death of two persons in Virginia. The individuals were criminally prosecuted by the
state authorities, and the pesticide company was prosecuted by the Department of Justice after state
and Federal authorities jointly decided that such a strategy would likely result in more severe
penalties for the two types of defendants.
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 should bring this fact promptly to the attention of 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 amenable to prosecution under one
of the other environmental laws or one of the general criminal laws.
Submission of false registration information may, for instance, not only may 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 Recovery and Conservation Act or
if the disposal was into a river, such conduct could amount to a criminal violation of the Clean Water
Act. Which statute to proceed under many not be decided until the investigation is almost complete
and may depend on factors such as the evidence available to establish an offense and the different
penalty levels of the involved statutes.
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 Office of Criminal Investigations provide the necessary instructions and
directions to the investigation team on these matters.
Pesticides Inspection Manual 20-2 January 1989
-------
Chapter Twenty FIFRA Criminal Enforcement
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 Office of
Criminal Investigation 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
Beginning in fall 1982, with a staff of 23 experienced criminal investigators, the criminal
enforcement program had grown to more than 65 Special Agents by 1990. These agents were formerly
with such law enforcement agencies as the FBI, Drug Enforcement Administration, Bureau of
Alcohol, Tobacco and Firearms, and the Internal Revenue Service. Each agent has had at least eight
years of experience in the field of law enforcement.
\-
Initially, the Special Agents were deputized by DOJ as Special Deputy United States Marshals,
giving them full power as law enforcement officers -- authorized to obtain and execute search and
arrest warrants, and to carry firearms. In October 1988, the 100th Congress enacted a law (18 U.S.C.
§ 3063) authorizing the Special Agents of EPA to exercise these law enforcement powers.
The criminal investigative staff is a part of the National Enforcement Investigations Center
(NEIC) in Denver, Colorado, 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 Customs) and
with state enforcement offices.
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 policy guidance
and training in criminal enforcement matters. An inspector should 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
Pesticides Inspection Manual 20-3 January 1989
-------
Chapter Twenty FIFRA Criminal Enforcement
occurred or is occurring at regulated sources. The issues are complex and even the highly trained
Special Agents in the Office of Criminal Investigations 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 Office of Criminal Investigations for
review and possible investigation. The FIFRA inspector is indispensable person in initially
uncovering and identifying pesticide violations that may warrant criminal enforcement action.
The problem is, how does one go about recognizing those actions that may potentially constitute
criminal violations? How does one recognize:
o Knowing or willful behavior—defined as criminal under all Federal statutes?
o 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 should 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 should be consulted. The following is exemplary only:
o Conflicting Data. Two sets of books, inconsistent monitoring reports on the same incident;
o Conflicting Stories. When an inspector is led to believe one thing and sees something quite
different in records or through observation;
o Unsubstantiated Data. Monitoring or other recordkeeping and reporting information
which lacks any record or information to support reported information should raise
suspicion;
o Deliberate Actions. When an employee says he was told to do something the FIFRA
inspector knows is illegal; or
o Claims of Ignorance About Requirements. Copies displaying knowledge are discovered in
the records, or other make statements during interviews of knowledge.
If any of these problems are in evidence, or others are present that make the inspector
suspicious, he or she should attempt to obtain further information through interviews, observations,
and records reviews and promptly consult with the OCI 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 should always follow the instructions of the Special Agent (and enforcement
attorney).
Pesticides Inspection Manual 20-4 January 1989
-------
Chapter Twenty FIFRA Criminal Enforcement
Searches
Investigators 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
sometimes 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 admissable in court to prove the crime. For example, information
collected by FIFRA inspector during a routine inspection (with consent or under an administrative
warrant) could be admitted as evidence in a criminal case because it was lawfully obtained. 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 admissable.
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 a him/her to provide information in a civil proceeding, the prosecutor's ability
to compel information in a criminal investigation is more powerful:
1. A witness who fails to appear in response to a subpoena is subject to immediate arrest;
2. An uncooperative witness can be forced to provide information through an enforceable
court order; and
3. 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.)
This contrasts with persons subpoenaed for a civil proceeding, as follows:
1. If a witness fails to comply with a subpoena, penalties can only be obtained after a hearing
(a process that can take weeks).
2. 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.
Pesticides Inspection Manual 20-5 January 1989
-------
Chapter Twenty F1FRA Criminal Enforcement
(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.
However, there are exceptions to the rule. For example, case law requires a prosecutor to give to the
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 prosecutors to adopt an
open file policy. It allows counsel for the defendant to access the prosecutor's entire file. However,
defendants in criminal cases 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's mind about the defendant's guilt after the conclusion
of a criminal case, the defendant is to 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 1, 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 Counsel has compiled a list of all individual and organizational defendants
who are placed on probation and the length of such probation. Inspectors should familiarize
Pesticides Inspection Manual 20-6 January 1989
-------
Chapter Twenty FIFRA Criminal Enforcement
themselves with the list to ensure that convicted criminal environmental violators are sufficiently
monitored to ensure that they do not repeat their criminal activity.
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 should 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 followup, 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 investi-
gation. 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 should 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 an 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 NEIC.
The Special Agent manages the investigation, under the supervision of the SAIC, and is
responsible for the following:
o Determining the basic investigative approach;
o Leading the conduct of interviews;
o Assembling and reviewing records;
o Planning and executing surveillances;
o Coordinating with the U.S. Attorney's office and other Federal, state, and local law
enforcement agencies;
o Communicating with informants;
o Contacting other witnesses;
Pesticides Inspection Manual 20-7 January 1989
-------
Chapter Twenty F1FRA Criminal Enforcement
o Performing other investigative functions;
o Completing all required reports; and
o Carrying out all coordination and notification requirements.
Inspectors may be assigned to assist work under the direction of the Special Agent.
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. If a
congressional inquiry is received, the Assistant Administrator for Enforcement and Compliance
Monitoring who works with the Congressional Liaison Officer prior to releasing any information or
making any public statements.
Written materials pertaining to the investigation must receive special care and attention. The
NEIC 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 verse. There are
five rules of thumb a FIFRA inspector can follow when involved in ongoing parallel proceedings:
o 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 Monitoring in order to seek immediate relief to protect
human health or the environment.
o Until the Agency refers a matter to the Department of Justice for possible criminal
prosecution, all EPA employees should continue to collect information (data) from
potential defendants with the understanding that it may be used to either in a civil or a
criminal enforcement action.
o No EPA employee should ever tell a person or entity from whom information is being
sought that it will not be used by the Agency a evidence in a criminal prosecution.
Pesticides Inspection Manual 20-8 January 1989
-------
Chapter Twenty FIFRA Criminal Enforcement
o 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 Office of Criminal Investigations) must have a clear need to obtain
such data for an existing regulatory purpose that is wholly separate and independent of the
criminal investigation.
o 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 should be factual, containing no opinions or
biases of the inspector. Finally, to avoid any potential appearance that Jencks Act material has been
lost, the inspector should throw nothing away -- not even a scrap of paper with rough calculations on
it. All materials associated with a criminal investigation should 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 grand jury 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 Monitoring.
Pesticides Inspection Manual 20-9 January 1989
-------
Chapter Twenty FIFRA Criminal Enforcement
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 five years' probation.
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
under that law than under either the Federal on state pesticide statutes.
Case Study No. 3
Two elderly residents died of exposure to the pesticide, vikane, shortly after their home had
been covered with a large tarpaulin and fumigated. Investigation showed that the commercial
pesticide application firm had not properly monitored the air within the home, lacked a formal
training program for its employees as to applying and handling pesticides, and that the supervisor had
not bothered to fully read the label of the deadly pesticide.
The company pled guilty to FIFRA charges and was fined $500,000 and placed on five years
probation.
Pesticides Inspection Manual 20-10 January 1989
------- |