Federal Insecticide, Fungicide,
and Rodenticide Act
COMPLIANCE/ENFORCEMENT
GUIDANCE MANUAL
U.S. ENVIRONMENTAL PROTECTION AGENCY
Washington DC 20460
Prepared by


Pesticides and Toxic Substances Compliance Monitoring Staff


and



Office of Legal and Enforcement Policy

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Table  of  Contents
Chapter One;   Overview

Purpose of the Manual
Overview of the Act
The Federal Insecticide, Fungicide and Rodenticide Act (As  Amended)
FIFRA Regulatory Elements
    Registration of  Pesticides
    Establishment Registration
    Pesticide Disposal
    Experimental Use Permits
    Emergency Exemptions for Federal and State Agencies
    State Registration of Pesticides
Glossary
Chapter Two;   General Operating Procedures

Primary Office Responsibilities
Concurrence Procedures
State and Federal  Interagency Cooperation
Organizational Charts
Chapter Three;   Compliance Monitoring Procedures

Introduction
Inspections
    Records  and  Establishment Inspections
    Use/Misuse Investigations
    Warrants
Subpoenas
Chapter Four;   Documentation of Evidence

Introduction
Inspection File Review
Review of Adequacy of Evidence
FIFBA ^^"•pl * MTtf^/itnfnfffmfmt-                           Guidance **"«">« 1983

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 Chapter Five;  Determination of Appropriate Enforcement Response

 Introduction                                          3 a ••,&#'•
 Level of Action Policy                   •        '-•-:.  ?rr: jS
                                                          i.'-.


 Chapter Six;  Administrative Enforcement Actions;  Notices of Violation and
 Administrative Orders

 Introduction
 Administrative Enforcement Procedures
 Chapter Seven;  Administration Enforcement Actions;  Civil Penalty
 Proceedings

 Introduction
 Elements of a Violation:  Administrative
 Complaint Preparation and Filing
 Pre-Hearing Stage
 Hearing Stage
 Post-Hearing .Stage
 Chapter Eight;   Judicial Enforcement;  Civil Actions

 Introduction
 Elements of a Violation:  Civil
 Procedures for Filing Actions
 Injunctive Actions
 In Bern (Seizure) Actions
 Settlement Agreements
Chapter NlTte^   Judicial Enforcement;   Criminal Actions

Statutory Authority
Basic Enforcement Policy
Criteria for Identification of a Potential Criminal Action
Procedures for the Investigation and  Referral of a Criminal Case
Chapter Ten;   Post-Settlement Enforcement

Monitoring Settlement Agreements
Enforcement of Settlement Agreements
 Chapter Eleven;   Special Considerations

TXZ1A .Section 7  Confidential Information
 Disclosure of Confidential Information
FIFKA Compliance/Enforcement                          Guidance Manual 1983

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Appendices

Neutral Administrative Inspection  Scheme
Notices of Judgment
Sample Record Status and Permanent Abeyance  Procedures
Collection of Civil Penalty Assessments
Expert Witnesses
Penalty Policies
Additional Sources of Compliance/Enforcement Information
FTFRA Covpllaiice/Enforceaent                           Guidance n*™*!  1983

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Chapter  One
Overview
Chapter Contents	     	   	Page
1  Purpose  of the Manual                                       1-1

   Reservation                                                 1-1
   The Update System                                           1-1
   Common Acronyms and Abbreviations Used in this  Manual         1-2
2  Overview of the Act                                         1-3

   Purpose  and Scope                                           1-3
   Authorities and Responsibilities                             1-4
   Synopsis of the Act                                         1-4
3  The Federal Insecticide,  Fungicide, and Rodentlcide Act       1-13
   (As Amended)
4  FIFRA Regulatory Elements                                    1-47

   4a  Registration of Pesticides                               1-49

       Applicability of Registration Requirements                1-49
       Registration Procedures                                  1-51
       Labeling Requirements                                    1-54


   4b  Establishment Registration                               1-55

       Authority                                               1-55
       Objectives                                              1-56
       Applicability of Registration Requirements                1-56
       Registration Procedures                                  1-57
       Establishment Registration Numbers                       1-58
       Establishment Production Reports                         1-59
                                       l-i           g^±4fnf» u^mmi 1983

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    Ac  Pesticide Disposal                                         1-63

        Authority                                                  1-63
        Enforcement Actions and Disposal Practices                 1-63
    4d  Experimental Use Permits                                   1-65

        Authority                                                  1-65
        Scope                                                      1-65
        Permit Application Procedures                              1-65
        Labeling Requirements                                      1-66
    4e  Emergency Exemptions for Federal and State Agencies        1-67

        Types of Exemptions                                        1-67
        Procedures To Be Followed                                  1-68
        Withdrawal of Exemptions                                   1-70
   4f   State Registration of Pesticides                           1-71

        Conditions for Section 24(c) Registration                  1-71
        Types of  Section 24(c) Registrations                       1-71
        Registration Disapproval/Suspension                        1-72
5  Glossary                                                       1-73
FIFRA CbppllOTCf/Enforcement1-11

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Chapter One
1     Purpose  of  the Manual
 The purpose of this manual is to provide guidance  to pesticide regulatory
 personnel on the substantive and procedural  requirements necessary for
 ensuring compliance and preparing enforcement  cases under the Federal
 Insecticide, Fungicide, and Rodenticide Act, as amended (FIFRA).

 The manual describes the processes of case development and Judicial pro-
 ceedings including the analyzing of evidence collected during a compliance
 inspection to determine its sufficiency to document a suspected violation;
 issuing of an enforcement action; presenting evidence in an adjudicatory
 hearing; and monitoring compliance with consent decrees.
 Reservation
The policies and procedures set forth herein and  the internal office proce-
dures adopted pursuant hereto are intended  solely for the guidance of U.S.
Environmental Protection Agency personnel.   These policies and procedures
are not intended to be relied upon to create a  right or benefit (substan-
tive or procedural) enforceable at law by a party to litigation with the
United States Environmental Protection Agency.  The Agency reserves the
right to take any action alleged to be at variance with these policies and
procedures or that is not in compliance with internal office procedures.
The Update System


As revised or additional material is  developed for the manual, it will be
distributed to all manual holders. A transmittal form will accompany and
explain these changes.  The revised or additional pages will be Identical
to the original page, but with added  identification at the bottom of the
page.
                                       Pag*      CkiMoe* Haimil (T*ir)
FIFMA compliance/mxorcement             1-1           Guidance narnuii

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 Chapter One
When revisions entail the addition of pages into the manual (i.e.,  when
three pages  in the manual are replaced by five pages), the additional pages
will be numbered as follows:

      Original numbering:  3-3, 3-4, 3-5,  3-6, etc.
      Addition of pages:    3-3, 3-4, 3-5a, 3-5b, 3-5c, 3-6, etc.

This system  will allow updates to be made quickly and easily and will avoid
disruption of the chapters.  New material will be numbered sequentially by
chapter.
Common Acronyms  and Abbreviations  Used in this Manual


C.F.R. —  Code of  Federal Regulations

CROP — Consolidated Rules of Practice

EPA — United States Environmental Protection Agency

FDA — Food and  Drug Administration

FIFRA — Federal Insecticide, Fungicide,  and  Rodentlcide Act,  as amended

HQCDO — Headquarters Case Development Officer

OLEC — Office of  Legal  and Enforcement Counsel

PTSCMS —  Pesticides and Toxic Substances Compliance Monitoring Staff

RCDO — Regional Case Development  Officer

RD — Registration Division

RHP — Restricted  Use Pesticide

SSDRO — Stop Sale,  Use,  or Removal Order

U.S.C. —  United States  Code
                                         1-2           Gold

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Chapter  One
2     Overview  of  the  Act
The Federal Insecticide, Fungicide,  and Rodenticide Act, Public Lav 92-516
(1972), as amended by Public Lav 94-140 (1975), Public Lav 95-396 (1978),
and Public Lav 96-539 (1980) vas passed by Congress as the primary statute
for pesticide control and regulation.  The Act, referred to as "FIFBA," is
codified in Title 7 of the United States Code.  Regulations promulgated
pursuant to the Act are found at 40  C.F.R. Parts 162 through 180.
Purpose and Scope


FIFRA and its amendments are designed  to provide for pre-market clearance
of pesticides and post-market surveillance of pesticides and pesticidal
devices to ensure prevention of  unreasonable adverse effects upon human
health or the environment.   Under  FIFRA, the term "pesticides" Includes:

     •  Substances (other'than "nev animal drugs" or animal feeds) intended
        for preventing,  destroying, mitigating, or repelling any "pest"
        defined to include  organisms ranging from viruses and bacteria to
        rodents; and

     •  Substances intended for  use as plant regulators, defoliants, or
        dessicants.

The Act prohibits (subject  to certain exceptions) any Individual from • ,
distributing, selling, offering  or holding for sale, •hipping, delivering
for shipment, or receiving  and (having so received) delivering or offering
to deliver any pesticide product not registered with the Administrator of
EPA.  Registration may be refused, restricted, suspended, or cancelled $>y
the Administrator where  appropriate to ensure protection of the environ-r
ment.  Under the Act, all producers of pesticides and pesticidal device*
ere required to register their establishments with the Administrator«1
FIFRA Case Proceedings Manual            1-3          ^^M Manual 1983

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  Chapter One    	Overview of the Act
 Products Not Subject to the Act

 Certain products are not classified as pesticides and, therefore, are not
 subject to the Act.  They include:

      -«   Deodorizers, bleaching agents, and cleaning agents for which no
          pesticidal claims are made;

      •   Paints and other formulated coatings that are treated with fungi-
          cides  to protect the coating Itself and that bear no claims for
          protecting other: surfaces or objects;

      •   Building material products (such as lumber, fiber boards, adhe-
          sives, and caulking material) that have been treated to protect the
          material Itself against pests and for which no pesticidal claims
          are  made as to protecting other surfaces or objects;

      •   Fabric products that have been treated to protect the fabric itself
          from insects, fungi, or other pests and .for which no pesticidal
          claims are made as to protection of other surf aces or objects;

      •   Fertilizers and other plant nutrients; and

      •   Intermediate substances intended for the production of a pesticide
          product by chemical reaction with other substances.
 Authorities and Responsibilities	_____	


The Administrator of EPA Is authorized to administer the Act  In a reason-
 able and prudent manner, often considering  the  economic, social, and
 environmental costs and  benefits  of  actions taken under FIFRA.   Within EPA,
 several offices are responsible for  providing national  guidance for FIFRA
 compliance enforcement activities.   These offices and their responsibili-
 ties are discussed in Chapter Two.
          of the Act                                             _


 FIFRA authorises the registration of pesticides as veil  as  pesticide-
 producing facilities.   Specific authorities are provided for  the inspection
 of establishments, books, and records.  The Act also provides for classifi-
 cation of pesticides for general use or restricted use;  certification of
 jBfipJLieatoxs £ or jesrrigted «sc pesticides; Issuance of experimental use
      ts; mud promulgation of pBsticide application standards . Protection
 is afforded trade secrets and certain other business information deemed
 confidential by the registration applicant.  Provisions are made under the
 Act for imposition of civil or criminal penalties.
       msqinsnrr/imrnrrrmciiL             A—«»            Guidance HSU*"' 19V3

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 Chapter  One	    	Overview of the Act
 Procedures  for issuing a stop sale,  use, or removal order (SSURO) or
 seizing  violative  pesticides  or  devices are detailed.  The statute also
 provides authority to  enter into cooperative agreements with the States.
 These  sections of  FIFRA are briefly  reviewed below.


 Registration of Pesticides (Section  3)

 Applications for registration must include information relating to the
 labeling of the pesticide as  well as the labeling Itself, a statement of
 all  claims made by the manufacturer, and directions for using the pesti-
 cide.  The Administrator is required to publish guidelines for the
 submission of  Information in  support of the application.  In general, an
 application will be approved  when the information submitted supports the
 assertion that the pesticide  will perform its claimed function(s) and indi-
 cates  that the pesticide will not present an unreasonable risk to the
 environment when used  properly.   The Administrator is required to classify
 all  pesticides for either general or restricted use or both; may condition-
 ally register  pesticide products that are Identical or substantially
 similar  to those currently registered;  and may approve new and added uses
 of currently registered pesticides.   The Administrator is required to
 accomplish the re-registration of all pesticides in the most expeditious
manner practicable.


 Use  of Restricted  Use  Pesticides; Certified Applicators (Section 4)

 EPA must  establish standards  for the certification of pesticide appli-
cators.   For those States that do not have a State certification plan
 approved  by the  Administrator, the Agency is to conduct its own certifica-
 tion program for pesticide, applicators.   Approval of a State's certi-
 fication  program may be withdrawn if the Administrator determines that the
 State program  Is not being administered  in accordance with the terms of the
approval.


 Experimental Use Permits (Section 5)

Any person may apply to the Administrator for an experimental use permit
 for a pesticide.   Approval of  the experimental use permit is conditional
upon the Agency's  review of the  application and all required supporting
data, as well  as the applicant's  need for Information to support the regis-
 tration.  The  permit may specify  terms and conditions deemed appropriate by
 the Administrator.  Should these  terms or conditions be violated, or inade-
quate to avoid an  unreasonable adverse effect on the environment, the
permit may be  revoked.


A^p<"istrative Review;  Suspension (Section 6)

The Administrator  shall  cancel the registration five years  from the  date of
registration unless the registrant or other interested person requests  the
continuance of the registration in accord with  re-registration regulations
fIFRA Compliance/Enforcement            1-5

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 Chapter One	Overview of the Act
 prescribed by the Administrator.  The Administrator 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 compliuace
 with the Act or if the pesticide causes unreasonable adverse effects to tne
 environment.  The Act requires that notice of the order be sent to the
 registrant and be made public.  A hearing to dispute the order must be
 provided to any person adversely affected by the notice.  The Administrator
 can also cancel a registration that was Issued conditionally if the regis-
 trant fails to meet any condition imposed or falls to Initiate and pursue
 appropriate action toward fulfilling any condition Imposed.  Section 6
 further provides that If a pesticide is determined to be an imminent hazard
 during the period required for cancellation or change of registration
 proceeding, its use may be Immediately suspended by the Administrator upon
 proper notice and availability of an expedited hearing.


 Registration of Establishments (Section 7)

 Any establishment producing pesticides, active ingredients used in produc-
 ing pesticides, or pestlcldal devices must be registered with the
 Administrator.  Information submitted in this registration process, other
 than the names of the pesticides or active ingredients used in producing
 pesticides, will be subject to the confidentiality provisions of Section
 10.
 Books and Records (Section 8)

 The  Administrator may prescribe regulations requiring producers to maintain
 records  pertaining to their operation as veil as pesticide and device
 records  considered necessary for the enforcement of the Act.  Financial
 data, sales data other than shipment data,, pricing data, personnel data,
 and  research data other than data relating to a registered pesticide or
 pending  registration are exempt from this rule.  Inspection and copying of
 shipping records or, in the absence thereof, records relating to shipment
 are  permitted upon presentation of proper credentials by a duly authorized
 employee of EPA or any State.
                i

 Inspection of Establishments (Section 9)

 T&XA authorize*, upon presentation of proper rcredentiale and -notice, the
 Inspection (at reasonable times) of establishments or other places where
 pesticides and devices are held for distribution or sale.  A written
 notice,  detailing the reason for the inspection and noting whether a viola-
 tion of  the law is  suspected, must be presented prior to entry.  Inspectors
 •ay  obtain camples  of any pesticides or  devices that are packaged, labeled,
 and  released for shipment and samples of any such containers and labeling.
 If necessary, tarranf* may fee obtained from a district court to gain entry«
Jjvpeet* and reproduce certain -records relating to pesticides or devices,
 or to seize any pesticide or device.  For minor violations, a written
 notice of warning may be issued.
FI7MA compliance/mx or ceeent            l-o            Guidance Manaaj. 190J

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 Chapter  One	                   Overview of the Act
Protection of  Trade  Secrets  and  Other Information (Section 10)

This  section of  FIFRA provides for the protection of trade secrets and
certain business  information obtained under FIFRA.  Applicants may claim
Information as confidential  or dispute the release by the Administrator of
any information  the  manufacturer feels is confidential.  United States
employees who willfully disclose trade secrets are subject to criminal
penalties.


Standards Applicable to Pesticide Applicators  (Section 11)

Separate  standards for licensing and  certification are established for
commercial and private applicators.   Private applicators are not required
to maintain any records or to file any reports.


Unlawful Acts  (Section 12)
             *
Section 12 establishes the acts  that  are  unlawful under FIFRA.  These
include, inter alia,  registration, labeling, and use violations.  See
Chapter Seven for a  complete listing.


Stop  Sale, Use, or Removal and Seizure (Section  13)

The Administrator may issue  a stop sale,  use,  or removal order under the
following circumstances:

      •  When, based  on inspection or  tests, there is reason to believe that
        a pesticide  or device is in violation  of the Act or will be sold or
        distributed  in violation of the Act; or

      •  When the registration of a pesticide has been cancelled or
        suspended.

Additionally (if certain unlawful acts are being carried out), pesticides
or devices may be seized for  condemnation upon action In a district court.


Penalties (Section 14)

Any registrant, commercial applicator,  wholesaler, dealer, retailer,  or
other distributor who  violates any provision of  the  Act Bay be assessed  a
civil penalty of up  to $5,000 per offense.   Should any of the above-
mentioned parties knowingly  or willfully  violate the Act, a criminal
penalty of up to $25,000 and/or  Imprisonment for up  to one year may be
imposed.  A private applicator or other person not Included above  who
violates the Act after receiving a warning  letter or citation for  a prior
violation may receive  a $1,000 civil penalty for each subsequent offense.
"For hire" applicators may be fined $500  for the first offense and $1,000
FIFgA Ooapli«nce/Enf orceaent            1-7            "Guidance"

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 Chapter One   	      	Overview of the Act
 for each subsequent offense.  Criminal penalties for private applicators
 and "for hire" applicators may be a fine of up to $1,000, 30 days' Impri-
 sonment, or both.


 Indemnities (Section 15)

 Under certain conditions EPA may make indemnity payments to persons
 suffering losses due to the cancellation or suspension of a pesticide
 registration.


 Administrative Procedure; Judicial Reviev (Section 16)

 District courts are given authority to review those Agency final actions
 that are not given to agency discretion by lav.  These courts are also
 vested with jurisdiction to enforce, prevent, and restrain violations of
 the Act.  United States courts of appeals have exclusive jurisdiction to
 affirm or set aside an order issued by the Administrator.  All judgments
 entered In actions instituted under -the Act are to be published.


 Imports and Exports (Section 17)

 Pesticides and pesticidal devices may not be imported for use In the United
 States If they violate any provision of the Act.  Pesticides or pesticidal
 devices Intended solely for export nay be produced and packaged according
 to  purchaser specifications but will be subject to certain provisions of
 Sections 2, 7, and 8 of the Act.


 Exemption of Federal Agencies (Section 18)

The Administrator may exempt Federal and State agencies from any provision
 of  the Act under emergency conditions.


 Disposal and Transportation (Section 19)

 Procedures and regulations for disposal and storage of pesticides must be
 established.  The Adminlntrator will advise «nd c*8ist the Department of
"Traaaiportatlon In matters relating to  ^he transportation of hazardous
 materials.  If a pesticide Is cancelled under Section 6(c), the
 Administrator, at the request of  the pesticide owner, Is to provide  a safe
 disposal site.  Specific provisions for the disposal of unused quantities
 of  a cancelled pesticide must appear In the notice of cancellation.
 HF1A ampliance/Bof orcement            1-8             Guidance Manual  1983

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 Chapter  One      	                     	Overview of the Act
Research and Monitoring  (Section  20)

Research necessary  to  carry  out  the Act  is  authorized.  The Administrator
will  formulate and  carry out a national  plan to monitor pesticide exposure
and pollution.


Solicitation of Comments; Notice  of Public  Hearings (Section 21)

The Administrator must solicit the views of the Secretary of Agriculture
prior to publishing regulations and may  solicit, from other interested
persons, views relating  to any action  authorized under the Act.  Timely
notice of all public hearings must be  published in the Federal Register.


Delegation and Cooperation (Section 22)

The Administrator may delegate to EPA  employees any or all vested authority
contained in the Act.  The Administrator must cooperate with other agencies
in carrying out the Act.


State Cooperation, Aid,  and Training (Section 23)

The Administrator may enter  into  cooperative agreements with States and
Native American Indian tribes for the  purposes of delegating authority to
carry out the Act and to train personnel.  The Administrator also may
assist them with contracts to encourage  training certified applicators.


Authority of States (Section 24)

A State may regulate the sale or  use of  any federally registered pesticide
or pesticidal device to meet its  special needs, as long as it is in accor-
dance with the Act.  The State may register new uses for registered pesti-
cides for use only in the State.  The  new use may not be a food or feed use
unless it is consistent with the  Federal Food,  Drug, and Cosmetic Act.
With just reason, the Administrator may  suspend the State's authority to
register pesticides under this section.


Authority of the Administrator (Section  25)

The Administrator nay prescribe regulations  to  carry out the Act*  Proposed
and ..final regulations must be given to the  Secretary of Agriculture for
comment.  All comments will be published In  the Federal Register on a pres-
cribed time schedule.  The House  and Senate  Agriculture committees must
also be notified.  A scientific advisory panel  will comment on the regula-
tions, using the same time schedule as the  Secretary of Agriculture, and
the comments will also be published in the  Federal Register.
      Itrnpliance/Etafor

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 Chapter One	   	    Overview of the Act
 The Administrator has  the  authority  to  determine  what  is  a pest,  to specify
 which devices are subject  to the Act, to establish  packaging standards  for
 pesticides and devices, to prescribe regulations  requiring pesticides  to be
 colored, to establish  suitable names for use  in active ingredient state-
 ments, and to determine whether pesticides are toxic to human health.


 State Primary Enforcement  Responsibility (Section 26)

 A State has the primary enforcement responsibility  for pesticide  use viola-
 tions (primacy) if the State laws and regulations are  deemed adequate by
 the Administrator, if sufficient enforcement  procedures are adopted and
 used, and if the State keeps records and makes reports of  such compliance
 as required by the Administrator.

 A State may also obtain primacy by entering into  cooperative agreement  for
 the enforcement of use violations under Section 23  or  by demonstrating  that
 their Section 4 certification plan meets the  criteria  described above.

 The Administrator has primary enforcement responsibility for States that  do
not have primacy.


 Failure by the State To Assure Enforcement of State Pesticide Use
 Regulations (Section 277

 The Administrator must notify the State of any significant  allegations  of a
 pesticide use violation of the Act.  If within 30 days of  the referral  the
 State has not commenced appropriate enforcement action, EPA may bring its
 own action.  The Administrator is empowered to rescind primacy if it is
 found that the State is not carrying out its pesticide use  enforcement
 responsibility.   If  an emergency exists and the State  is unable or
unwilling ;to'^respond, ^the Administrator is authorized  to
action.
Identification of Pests; Cooperation with Department of Agriculture's
Program  (Section 28)

The Administrator, In coordination with the Secretary of Agriculture, Is to
identify those pests that must be controlled..  -In. addition, the
*•*•*«»*«*»•»»•*«• 4 « »« coordinate *lth the Secretary of .Agriculture *s research
and Implementation programs in order to determine the safest and most
effective pesticides or control methods available.


Annual Beport (Section 29)
An f«»T«M»i xeport must be submitted to: Congress igr the Adaliilstrstor before
         16 *>f - each year » llstlTig all the applications for conditional
FXTKA. Uumplimnri*/Enff>-rf*mt>*tt-            1—10           ^'*lff"'** MOT***1 1983

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  registration and approvals of  such applications.  The findings, imposi-
  tions,  modifications,  and  quantities of each conditionally registered
  pesticide  that  is  produced must  be included.
fUFHA. Compliance/Enfor
1-11
               Guidance
                                                                       1933

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  Chapter One	Overview of the Aft-
ruts* ump.Liance/EQ±orce»ent

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Chapter One
3      Federal   Insecticide,   Fungicide,  and
         Rodenticide  Act  CAs  Amended]
                               La* 92-Stt, Kmt Cityim, HJt. 10739, Omkm U, 1972

                              Law M.51. tt* Caavwa. HJL 43T7, My 2. 1973;
                              Lav M.IM. Mak Ciaraa. S. 2375. Qtntir 10, 1975;
                              Law M.I4*. M* CaaanH, HJL SS41, .Ntnartrr 2S. 19*5:
                              Law 95-231, 93* CoapM. HJL 6975, Mart* 27. 1978:
                              Uw 99.394. 95ta Caaaru*. S. K7S. ScateMtar M. 1978:
                                            o«tm§. Dict«>y 17. 19W)
                                          fln flct
          Ktdcral
          l-nvironmcnlil
          Pmicidt
          Control Ao
          ol 197:.
          61 Slic. 163:
          71 Sill. 190.
                                              86 STAT. 973-999

  To amend the Federal Insecticide, Fungicide, and Rodenticide Act, and For
other purposes.

  Be it enacted by the Senate and House Representatives of the United Slates
of America in Congress assembled. That this Act may be cited as the "Federal
Environmental  Pesticide Control Act of 1972."

  Amendments to Federal Insecticide, Fungicide, and Rodenticide Act

Sec. 2. The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136
et seq.) is amended to read as follows:
       "SECTION 1. SHORT TITLE AND TABLE OF CONTENTS.

         (a) Short Title — This Act may  be cited as the  'Federal Insecticide,
       Fungicide, and Rodenticide Act'.
         (b) Table of Contents —
       "Section I. Shori title and table of comems.
            "(a)  Short tide.
            "(b)  Table of contents.
       "Sec. 2. Definitions.
            "(a)  Active ingredient.
            "(b)  Administrator.
            "(c)  Adulterated.
            "(d)  Animal.
            "(e)  Certified applicator, etc.
                 "(I) Certified applicator.
         _      "(2) Private applicator.
                 "(3) Commercial applicator.
        •        "(4) Under the direct supervision
                 of a certified applicator.
            "(0  Defoliant.
            "(I)  Desiccant.
      '     "(h)  Device.
            "(i)  District court.
            "(j)  Environment.
            "(k)  Fungus.
            "(I)  Imminent hazard.
            "(m)  Inert ingredient.
            "(n)  Ingredient statement.
            "(o)  Insect.
            "(p)  Label and labeling.
                 "(I) Label.
                 "(2) Labeling.
                                                                        P.I..
                                                  42 Sill. »J»
                              "(q)  Misbranded.
                              "(r)  Nematode.
                              "(s)  Person.
                              "(t)  Pest.
                              "(u)  Pesticide.
                              "(v)  Plant regulator.
                              "(w)  Producer and produce.
                              "(x)  Protect health and the environ-
                              ment.
                              "(y)  Registrant.
                              "(2)  Registration.
                              "(aa) Stale.
                              "(bb) Unreasonable adverse effects on
                              the environment.
                              "(cc) Weed.
                              "(dd) Establishment.
                              "(ee) To use any registered pesticide in a
                              manner inconsistent with its labeling.
                          "Sec. 3. Registration of pesticides.
                              "(a)  Requirement.
                              "(b)  Exemptions.
                              "(c)  Procedure for registration.
                                   "(I) Statement required.
                                   "(2) Data in support .of registra-
                                   tion.
       umpJJLance/jgnxorceaent
                              1-iJ
Mirnnin  1983

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 Chapter  One
                                                                                                     FIFRA
                         "(3) Time for acling with respect
                         to application.
                         "(4) Notice of application.
                         "(5) Approval of registration.
                         "(6) Denial of registration.
                         "(7) Registration under special cir-
                         cumstances.
                         "_(%) Interim administrative review •
                   "(d)   Classification of pesticides.
                         "(I) Classification for general use,
                         restricted use.  or both.
                         "(2) Change in classification.
                         "(3) Change in classification  from
                         restricted use to general use.
                   "(e)   Products with same formulation
                   and claims.
                   "(0   Miscellaneous.
                         "(I) Effect of change of labeling
                         or f01 mutation.
                         "(2) Registration not a defense.
                         "(3) Authority 10 consult other
                         Federal agencies.
                   "(g)   Registration  of pesticides.        ,
            "Sec. 4. Use of restricted use pesticides; certified
            applicators.
                   "(a)   Certification procedure.
                         "(I) Federal certification.
                         "(2) Slate certification.
                   "(b)   State plans.
                  ."(c)   Instruction in integrated pest
               '  . management'techniques.
            "Sec. S. .Experimental use permits.
                   "(a)   Issuance.
                   "(b)   Temporary tolerance level.
                   "(c)   Use under permit.
                   "(d)   Studies.
                   "(e)   Revocation.
                   "(0   State issuance of permits.
                   "(g)   Exemption for agricultural research
                   agencies.
            "Sec. 6. Administrative review;suspension...
                   "(a)   Cancellation after five years.
                         "(I) Procedure.
                         "(2) Information.
                   "(b)   Cancellation and change in classifi-
                   cation.
                   "(c)   Suspension.
                         "(I) Order.
                         "(2) Expedite  hearing.
                         "(3) -Emergency order.
                         "(4) Judicial review.
                         Public heai ings and -scientific re-
            "Sec.
             Sec.
                                                   • "Sec.
                                                    "Sec.
                                                          "(b)
                                                    "Sec.
      view.
      "(e)  Conditional registration.
      "(0  Judicial review..
      7. Registration of establishments.
      "(a)  Requirements.
      "(b)  Registration.
      "(c)  Information required.
      "(d)  Confidential records and informa-
      tion.
     , 8. Books and records.
      "(a)  Requirement.
      **|b)  Inspection.

      "(a)  In general.
    _"(b)_ Warrants.
'   '   "yita TiaM HBMII  nTnin
 
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Chapter  One
                                            FIFRA
           "SEC. 2. DEFINITIONS.

             "For purposes of this Act—
             "(a) Active Ingredient.—The term 'active ingredient' means—
                  "(1) in the case of a pesticide other than a plant regulator, defoliant,
                or desiccant, an ingredient  which  will prevent, destroy, repel, or
                mitigate any pest;
                  "(2) in the case of a  plant regulator, an ingredient which, through
                physiological action, will accelerate or retard the rate of growth or rate
                of maturation or otherwise alter the behavior of ornamental or crop
                plants or the product thereof;
                  "(3) in the case of a defoliant, an ingredient which  will cause  the
                leaves or foliage to drop from a plant; and
                  "(4) in the case of a desiccant, an ingredient which will artificially ac-
                celerate the drying of plant tissue.
             "(b) Administrator.—The term 'Administrator* means the Administrator
           of the Environmental Protection Agency.
             "(c) Adulterated.—The term 'adulterated* applies to any pesticide if:
                  "(I) its strength or purity falls below the professed standard of quali-
                ty as expressed on its labeling under which it is sold;
                  "(2) any substance has been substituted wholly or in part  for  the
                pesticide;  or
                  "(3) any valuable constituent of the pesticide has been wholly or in
                part abstracted.
             "(d) Animal.—The  term 'animal* means all  vertebrate and invertebrate
           species, including but not limited to man and other mammals, birds, fish, and
           the shellfish.
             "(e) Certified Applicator, Etc.—
                  "(I) Certified applicator.—The term 'certified applicator' means any
                individual who is certified under section 4 as authorized to use or super-
                vise the use of any pesticide which is classified  for restricted use. Any
                applicator who holds or  applies registered pesticides, or use dilutions of
                registered pesticides consistent with section 2
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 Chapter  One	PIFRA
                             "(k) Fungus. — The  term  'fungus' means any  non-chlorophyll-bearing
                           thallophyte (thai is, any non-chlorophyll-bearing plant of a lower order than
                           mosses and liverworts), as for example, rust, smut, mildew, mold, yeasi, and
                           bacteria, except those on or in living man or other animals and those on or in
                           processed food, beverages, or Pharmaceuticals.
                             "I) Imminent Hazard.—The term 'imminent hazard* means a situation
                           which exists when the continued use of a pesticide during the time required for
                           cancellation proceeding would  be likely to result in unreasonable adverse ef-
                           fects 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 91-133.
            «.iMa..:7.v          "(m) Inen Ingredient.—The term  "inert ingredient' means an ingredient
            IMIM MUUV.I.     which is not active.
                             "(n) Ingredient Statement.—The term 'ingredient statement' means a state-
                           ment which, contains—
                                   *'(!) 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, calculated as elementary
                                 arsenic.
                             "(o) Insect.— The term 'insect*  means any of the numerous  small in-.
                           vertebrate  animals generally  having the body more  or  less  obviously
                           segmented, for the most part  belonging to the class insecta, comprising six-
                           legged, usually winged forms, as for example, beetles, bugs, bees, flies, and to
                           other allied classes of arthropods whose  members are wingless and usually
                           have more than six  legs, as for example, spiders, mites, ticks, centipedes, and
                           wood lice.
                             "(p) Label and Labeling.—
                                   "(I)  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
                                   publications of the Environmental Protection  Agency, the United
                                   Slates Departments of Agriculture and Interior, the Department  of
                                   Health, Education, and Welfare, State experiment stations, State
                                   agricultural colleges, and other similiar Federal or State institutions
                                   or agencies authorized by law to conduct research in the field  of
                                   pesticides.
                             "(q) Misbranded.—
                                  "on the label «r labeling is not
                           .      :  pronuueudy placed thereon wit*i:suco compkuousness (as compared
                                   with other words, statements, designs, or graphic matter in the label-
                                   ing) and in such terms as to render it likely to be read and understood
                                   by the ordinary individual under customary conditions of purchase
                                   and use;
                                     "(F) the labeling accompanying it does not contain directions for
                                   use which are necessary for effecting the purpose for which the
                                   product is intended and  if complied with, together with any re-
            i us*  i3«i.                quirements imposed under section 3(d) of (his Act, are adequate to
                                   protect health and the .environment;
                                 *   ••(Qtte'lRM.doesiBM caatraavnraagorc^
                                   which ttgy-be necessary and if compiled1 with, together with any re-
            T use  iite.                quirements imposed under section 3(d) of this  Act, is adequate to
                                   protect health and the environment; or
            PL ts-jw: nsut it*         "(if) in the case of a pesticide not registered in accordance with
            7 use IN*.                section 3 of this Act and intended for export, the label does not con-
                                   tain, in words prominently placed thereon with such conspicuousness
FXftA 
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Chapter One	    FIFBA
                  (as compared with other words, statements, designs, or graphic mat-
                  ter in the labeling) as to render it likely to be noted by the ordinary
                  individual under customary conditions of purchase and use,  the
                  following: 'Not Registered for Use in the United States of America'.
                  "(2) A pesticide is misbranded if—
                     "(A) the label does not bear an ingredient statement on that pan
                  of the immediate container (and on the outside container or wrapper
                  of the retail package, if there be one, through which the ingredient
                  statement on the immediate container cannot be clearly read) which
                  is  presented or displayed under customary conditions of purchase,
                  except that a pesticide is not misbranded under this subparagrapn if:
                       "(i) the size of form of the immediate container, or the outside
                     container or wrapper of the retail package, makes it impracticable
                     to place the ingredient statement on the part which is presented or
                     displayed under customary conditions of purchase: and
                       "(ii)  the ingredient statement appears prominently  on another
                     part of the immediate container, or outside container or wrapper,
                     permitted by the Administrator;
                    "(B) the  labeling  does  not  contain a statement of the  use
                  classification under which the product is registered;
                    "(Q there is not affixed to its container, and to the outside con-
                  tainer or wrapper of the retail package, if there be one, through
                  which the required information on the immediate container cannot
                  be clearly read, a label  bearing—
                       "(i) the name and address of the producer, registrant, or per-
                     son for whom produced;
                       "(ii)  the name, brand, or trademark under which the pesticide
                     is sold;
                       "(iii) the net weight or measure of the content; Provided. That
                     the  Administrator may permit reasonable variations; and
                       "(iv) when required by regulation of the Administrator to ef-
                     fectuate the purposes of this  Act, the registration number as-
                     signed to the pesticide under this Act, and the use classification;
                     and
                    "(D) the pesticide contains any substance or substances in quan-
                  tities highly toxic to man, unless the label shall bear, in addition to
                  any other matter required by this Act—
                    "(i)  the skull and crossboncs;    	
                    "(ii) the word 'poison* prominently in red on a background of
                  distinctly contrasting color; and
                    "(iii) a statement of a practical treatment (first aid or otherwise)  j
                  in  case of poisoning by the pesticide.                             !
            "(r) Nematode.—The term 'nematode' means invertebrate animals of the  ,
          phylum  nemathelminthes and class nernatoda, that is, unsegmented round
          worms with elongated, fusiform, or saclike bodies covered with cuticle, and
          inhabiting soil,  water, plants, or plant parts; may also be called nemas or  ,
          eelworms.
            "(s) Person.—The term  'person'  means any  individual,  partnership,
          association, corporation, or any organized group of persons whether incor-
          porated  or not.
            "(t) Pest.—The  term 'pest*  means (1) any insect, rodent,  nematode,
          fungus,  weed, or (2) any other form of terrestrial or aquatic plant or animal
          life or virus, bacteria, or other micro-organism (except viruses, bacteria, or
          other micro-organisms on or in living man or other living animals) which the
          Administrator declares to be a pest under section 2S(cXO.                      ruse i»>.
            "(u) Pesticide.—The term'pesticide'means (I) any substance or mixture of     IM..W-MO:
          substances intended for preventing, destroying, repelling, or mitigating any     ** *"• 7J4
          pest, and (2) any substance or mixture of substances intended for use as a plant
          regulator, defoliant, or desiccant: Provided, That the term •pesticide' shall not
          include any article (IXa) that is a 'new animal drug* within the meaning of sec-
          tion 20l(w) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 32l(w)).
         •or (b)-that has been determined by the Secretary of Health, Education, and
          Welfare  not to be a new animal drug by a regulation estabHshhig condhioos of
          use for the article, or (2) that is an animal feed within the meaning of section
          20l(x) of such Act (21 U.S.C.321(x)) bearing or containing an article covered
          by clause (1) of this proviso."
            'X v)  Plant Regulator.—The term 'plant regulator' means any substance or
          mixture  of substances intended, through physiological action, for accelerating
          or retarding the rate of growth or rate of maturation, or for otherwise altering
          the behavior of plants or the produce thereof, but shall not include substances
        .  to the extent that they are intended as plant nutrients, trace demerits, nutri-
          tional chemicals, plant inoculants. and soil amendments. Abo, the term 'plant



        Compliance/Enforcement                 PIT          '	Guidance Manual  1963

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Chapter  One
                                                                           FIFRA
         P.L. M-3%:
         P.L. M-3W:
         TUSCIMc. IMo. IM.
         7 USC IM>-4 MMC.
 regulator' shall not be required to include any of such of those nutrient mix-
 lures or soil amendments as are commonly known as vitamin-hormone hor-
 ticultural products, intended for improvement, maintenance, survival, health,
 and propagation of plants, and as are not for pest destruction and are non-
 toxic, nonpoisonous in the undiluted packaged concentration.
   "(w) Producer and Produce.—Tin term 'producer* means the person who
 manufactures, prepares, compounds, propagates, or processes any pesticide or
 device or active ingredient used in producing a pesticide. The 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 accor-
 ding to the directions on registered labels shall not of itself result in such in-
 dividuals being included in the definition of 'producer' for the purposes of this
 Act."
   "(a) Protect Health and the Environment.—The terms 'protect health and
 the environment' and 'protection of health and the environment' mean protec-
 tion against any unreasonable adverse effects on the environment.
   "(y) Registrant.—The term 'registrant' means a person who has registered
 any pesticide pursuant to the provisions of this Act.
   "(z)  Registration.—The term 'registration' includes reregistration.
   "(aa) Slate.—The term 'Slate* means a State, the District of Columbia, the
 Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Trust Territory
 of the Pacific Islands, and American Samoa.
   "(bb) Unreasonable Adverse Effects  on the Environment.—The  term
 'unreasonable adverse effects on the environment* means 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.
   "(cc)  ***«/.—The  term 'weed' means any plant whkhjrows where not
  "(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 Use Any Registered Pesticide in a Manner Inconsistent With Its
Libeling.—The term 'to uscany registered pestiseide in a manner inconsistent
with its labeling'- means to use any registered pesticide in a manner not permit-
ted by the labeling: Provided, That the term shall not include (I) applying a
pesticide at any 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 b 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 appUcatica not prohifaited by the Jabetmg. or (4)
       a.pfttiHnV or pfjtiodes with a ffTtjhrrf-when.SBciiJBO>ture is not pro-
bibbed by the labeling: Piovided further. That the term also shall not include
any use of a pesticide inconfonnance with section 3.18, or 24 of this Act, or any
use of a pesticide in a manner that the Administrator determines to be consis-
tent with the purposes of this Act: And provided further. That after March 31,
1979. the tern 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.
                            "(a) Requirement.— Except as otherwise provided by this Act, no person in
                          any State may distribute, sell, offer for sale, bold for sale, ship, ddrm for
                          shipment, or receive and (having so received) delivery or offer to deliver, to
                          any person any pesticide which is not registered with the Administrator.
                            "(b) Exemptions.— A pesticide  which b not  registered  with the Ad-
                          ministrator may be transferred if—
                                  "(1) the transfer is from  one registered  establishment to another
                               registered establishment  °Pe™J*^_^r  *** «ame .producer so/dy for

                                      i jaisiiirti
                                  "(2) the transfer  is pursuant to and in accordance with  the re-
                               quirements of an experimental use permit.
                            "(c) Procedure for Registration.—
                                  (I)  Statement required.— Etch  applicant  for registration of  a
                               pesticide shall file with the Administrator a statement which includes—
                                     snt
                                i-lo
Golda&ce Manual 1983

-------
                                                                                             MFEA
                "(A) the name and address of the applicant and of any other per-
              son whose name will appear on the labeling;
                "(B) the name of (he pesticide;
                "(C) a complete copy of the labeling of the pesticide, a statement
              of all claims to be made for it, and any directions for its use;
                "(D) except as otherwise provided in subsection (c)(2XD) of this
              section, if requested by the Administrator, a full description of the
              tests made and the results thereof upon which the claims are based,
              or alternatively a citation to data that appears in the public literature
              or that previously hadjwen submitted to the Administrator and that
              the Administrator may consider in accordance with the following
              provisions:
                  "(i) with respect to pesticides containing active ingredients that
                are initially registered under this Act after September 30,  1978,
                data submitted to support the application for the original registra-
                tion of the  pesticide, or an application  for an amendment adding
                any new use to the registration and that pertains solely to such
                new use, shall not, without the written permission of the original
                data submitter, be considered by the Administrator to support an
                application by another person during a period of ten years follow-
                ing the date the Administrator first registers the pesticides: Pro-
                vided, That such permission shall not be required in the case of
                defensive data;
                  "(ii) except as otherwise provided in subparagraph (DX>) of
                this paragraph, with respect to data submitted after December 31,
                1969, by an applicant or registrant to support an application for
                registration, experimental  use permit, or amendment adding a
                new use to  an existing registration, to support or maintain in ef-
                fect an existing registration, or for reregistration, the Adminis-
                trator may, without the permission of the original data submitter,
                consider any such item of data in support of an application by any
                other person (hereinafter in this subparagraph referred to as the
                'applicant') within the fifteen-year period following the date the
                data were originally submitted only if the applicant has nude an
                offer to compensate the original data submitter and submitted
                such offer  to  the Administrator accompanied by evidence of
                delivery to the original data submitter of the offer. The terms and
                amount of compensation may be fixed by agreement between the
                original data submitter and the applicant, or, failing such agree-
                ment, binding arbitration under this subparagraph. If, at the end
                of ninety days after the date of delivery to the original data sub-
                mitter of the offer to compensate, 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
                the amount and terms of compensation, either person may initiate j
                binding arbitration proceedings by requesting the Federal Media- i
                lion and Conciliation Service to appoint an arbitrator from the j
                roster of arbitrators 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, and the  findings
                and determination of the arbitrator shall be final and conclusive,
                and no official or court of the United States shall have power or
                jurisdiction to review any such findings and determination, except
              .  for  fraud, misrepresentation, or other misconduct by one of the
              .  panics to the arbitration or the arbitrator where there is a verified
              [  complaint  with supporting affidavits  attesting to specific in-
              *  stances of such fraud,  misrepresentation, or other misconduct.
                The parties  to the arbitration shall share equally in the payment of
                the  fee and  expenses of the arbitrator. If the Administrator deter-
                mines that an original data submitter has failed to participate in a
                procedure  for  reaching an agreement or in an arbitration pro-
                ceeding as required by this subparagraph, or failed to comply with
                the  terms of  an agreement or arbitration decision concerning
                compensation under this subparagraph, the original data submit-
                ter shall forfeit the right to compensation for the use of the data
                in support of the application. Notwithstanding any other provi-
                sion of this Act, if the Administrator determines that an applicant
 P.L. 9J.J96:
 92Sl«l. 120.
 (Set note
 
-------
Chapter  One	FIJKA
                                      has failed to participate in a procedure for reaching an agreement
                                      or in an arbitration proceeding as required by this subparagraph,
                                      or failed to comply with the terms of an agreement or arbitration
                                      decision  concerning compensation under this subparagraph, the
                                      Administrator shall deny the application or cancel the registration
                                      of the pesticide in  support of which the data were used without
                                      further  hearing. Before  the Administrator  takes action under
                                      either of the preceding two sentences, the Administrator shall fur-
                                      nish to the affected person, by certified mail, notice of intent to
                                      take actions and allow fifteen days from the date of deliver)' of
                                      the notice for the affected person to respond. If a registration is
                                      denied  or canceled under this subparagraph, the Administrator
                                      may  make such order as the Administrator deems appropriate
                                      concerning the continued sale and use of existing stocks of such
                                      pesticide.  Registration action by the Administrator shall not be
                                     . delayed pending the fixing of compensation;
                                        "(iii) after expiration of any period of exclusive use and any
                                      period for which comprmation is required  for the use of an item
                                      of data under subparagraphs (DXO and (DXn) of this paragraph,
                                      the Administrator may consider such hero 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 compensate the original data submitter for the use of
                                      such  item of data;
                                     "(E) the complete formula of the pesticide; and
                                     "(F) a request that  the pesticide be classified  for general use, for
                                 . .restricted use, or for both.
                                   "(2)  (A) Data in support pftrgaiiatioa.—The Administrator shall
                                   publish guidelines specifying the kinds of information which will be
                                   required to support the registration of a pesticide and shall revise
                                   such guidelines from time to time. If thereafter he requires any addi-
                                   tional  kind  of information  under subparagraph (B)  of this
                                   paragraph, he shall permit sufficient time for applicants to obtain
           IISIIH'KU                sucn tddkional  information. The  Administrator, in establishing
                                   standards  for data requirements for the registration of pesticides
                                   with respect to minor uses, shall make such standards commensurate
                                   with 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 factors of potential national volume of
                                   use, extent of distribution, and the impact of the cost of meeting the
                                   requirements on the incentives for any potential registrant to under-
                                   take the development  of the required data. Except as provided  by
           7usci3«o               section  JO,  within JO-days after the Attainiitrator  registers  a
                                  spenkide under this Act he,sball jnakeavailable to tnepufaik the
                                  data called for in the registration statement together with such other
                                   scientific information as he deems relevant to his decision.
                                     "(B) Additional data to support existing registrations.—
           nSM?n?                     "® lf lhe Administrator determines that additional data are
                                      required  to  maintain in effect an existing registration of  a
                   .                   pesticide, the Administrator shall notify all existing registrants of
                                      the pesticide to which the determination relates and provide a list
                                      of such registrants to any interested
                                  wrson.
                                        "GO Each registrant of such pesticide shall provide evidence
                              pest*
within ninety days after receipt of notification that it»taking ap-
                                              arc:required
                                                                      ttrnVrrinft jointly, or to ihtrr
                                      mtfce tost or developing, such data if they agree and advise the
                                      Administrator of their intent within ninety days after notification.
                                      Any registrant who agrees to share in the cost of producing the
                                      data shall be entitled to examine and rely upon such data in sup-
                                      port of maintenance of sod) registration.
                                        "(uT) If, at  the end of sixty  days  after advising  the Ad-
                                      ministrator of their agreement to develop jointly, or share in the
                                      cost of developing, data, the registrants have not further agreed
                                      on the terms of the data devdopmenl anaogeroent or on a pro-
                                    - fledorefw reaching sacbaaveemenl, any of sacoK(istrants faay
                                      initiate fciadMKarbiuaUuii |»w«cuHigs %Tequesting the Federal
                                      Mediation and Conciliation Service to appoint an arbitrator from
                                      the roster of arbitrators maintained by such Service. The pro-
                                      cedure 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 shall be final and
        tirarpllance/EnlorceMnt                 P25          " - Guidance Manual  1583

-------
 loapter  One
                                                                                                      FIFRA
                       conclusive, and no official or court of the United States shall have
                       power or jurisdiction to review any such findings and determina-
                       tion, except for fraud, misrepresentation, or other misconduct by
                       one of the parties to the arbitration or the arbitrator where there
                       is a  verified complaint with supporting affidavits attesting to
                       specific  instances  of such  fraud, misrepresentation,  or  other
                       misconduct. All parties to the arbitration shall share equally in the
                       payment of the fee and expenses of the arbitrator.
                         "(iv) Notwithstanding any other provision of this Act,  if the
                       Administrator determines that a  registrant,  within the time re-
                       quired by the Administrator, has failed to take appropriate steps
                       to secure the data required under this subparagraph, to par-
                       ticipate in a procedure for reaching agreement concerning a joint
                       data development arrangement under this subparagraph or in an
                       arbitration proceeding  as  required by this subparagraph,  or to
                       comply with the terms of an agreement or arbitration decision
                       concerning a joint data development arrangement under this sub-
                       paragraph, the Administrator may issue a notice of intent to sus-
                       pend such registrant's registration of the pesticide for which addi-
                       tional data is required. The Administrator  may  include in the
                       notice of intent to suspend such provisions as the Administrator
                       deems appropriate concerning the continued sale and use of ex»
                       isting stocks  of such pesticide. Any suspension proposed under
                       this  subparagraph shall become final and effective at the end of
                       thirty days from receipt by the registrant of the notice of intent to
                       suspend, unless during that time a request for hearing is made by
                       a person adversely  affected by the notice or the registrant has
                       satisfied the Administrator that the registrant has complied  fully
                       with the requirements that served as a basis for the notice of in-
                       tent  to suspend. If a hearing is requested, a hearing shall be con-
                       ducted under section 6(d) of this Act: Provided,  That the  only
                       matters  for  resolution  at  that  hearing shall be whether  the
                       registrant has failed to take the action that served as the basis for
                       the notice of intent to suspend the registration of the pesticide for
                       which additional  data  is  required,  and  whether  the  Ad-
                       ministrator's  determination with respect to the disposition of ex-
                       isting stocks is consistent with this Act. If a hearing is held, a deci-
                       sion after completion of such hearing shall be final. Notwith-
                       standing any other provision of this Act, a hearing shall be held
                       and a determination made within seventy-five days after receipt of
                       a request for such hearing. Any registration suspended under this
                       subparagraph shall be reinstated by the Administrator if the Ad-
                       ministrator determines that the registrant has compiled fully with
                       the requirements that served as a basis for the suspension of the
                       registration.
             "(v) Any data submitted under this subparagraph shall be  subject to the
           provisions of subsection (cXIXD) of this section. Whenever such data are sub-
           mitted jointly by two or more registrants, an agent shall be agreed on at the
           time of the joint submission to handle any subsequent data compensation mat-
           ters for the joint submitters of such data.".
                      "(Q  Simplified procedures.—Within  nine  months after date of
                   enactment of (his subparagraph, the Administrator shall by regula-
                   tion,  prescribe  simplified  procedures  for  the  registration  of
                   pesticides, whkh shall include the provisions of subparagraph (D) of
                   this paragraph.
                      "(D) Exemption.—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 an end-use
                   product shall be required to—
                        "(i) submit or cite data pertaining to the safety of such  pur-
                       chased product; or
                        "("') offer  to pay reasonable compensation otherwise required
                       by paragraph (1KD) of this subsection for the use of any such
                       data.".
                   "(3) Tune  for   acting  with   respect to  application.—-The   Ad-
                 ministrator shall review the data after receipt of the application and
                 shall, as expeditiousiy as possible, either register the pesticide in accor-
                 dance with paragraph (5), or  notify the applicant of his determination
                 that it does not comply with the provisions of the Act  in accordance
                 with paragraph (6).
                   "(4) Notice of application.—The Administrator shall publish in the
                 Federal Register, promptly after receipt of the statement and other data
                 required pursuant to paragraphs (1) and (2), a notice of each application
                 for registration of any pesticide if it contains any new active ingredient
                             Payment of
                             arbitrator.
                            Hearing.
                            T USC IJ6d
                           P.L. »J.J*6;
                           n Stal. U4.
                           P.L. t»-J»6:
                           n St*. W«
                           Federal *<*««.
FIFRA  Goapllance/Eaforceaent"
1-21
Guidance Manual 1983

-------
 Chapter One
            P.L. W-M6:
            n SMI. 115
            7 USC I3*».
            PuMieaimn in
            Federal fttgbK
            I'.I •»«•>•*:
            «: Mm «:.«.
 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 registration. — The Administrator shall register a
 pesticide if he 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 com-
   ply with the requirements of this Act;
      "(C) 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 adverse
   effects on the environment.
 The Administrator shall not make any lack 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  application for  the  registration of a
 pesticide, the Administrator may waive data requirements pertaining to
 efficacy, in which event the Administrator may register the pesticide
 without determining that the pesticide's composition is such as to war-
 rant 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 ef-
 ficacy for use of the pesticide in such State.
   "46) *Deniat of registration.— 11 .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 dur-
 ing the 30-day period beginning with the day after the date on which the
 applicant receives the notice, the Administrator may  refuse to register
 the  pesticide.  Whenever  the  Administrator  refuses  to register  a
 pesticide, he shall notify the applicant of his decision and of his reasons
 (including the factual basis) therefor. The Administrator shall promptly
 publish in the Federal Register notice of such denial of registration and
 the reasons therefor. Upon such notification, the applicant for registra-
 tion or  other interested person with the concurrence of the applicant
 shall have the same remedies as provided for in section  6.
   "(1)  Registration under special circumstances. — Notwithstanding the
 provisions of subsection (cMS) of this section —
      "{A) The Administrator may conditionally register or amend the
   regismiioo of a.pestkide if .the Administrator determines thai (i) the
   pcsiiridr and .proposed use are identical or substantially similar to
   any currently registered pesticide and use thereof, or differ only in
   ways that would not significantly increase the risk of unreasonable
   adverse effects on the environment, and (ii) approving the registra-
   tion or amendment in the manner proposed by the applicant would
   not significantly increase the risk of any unreasonable adverse effect
   on the environment. An applicant seeking conditional registration or
   amended registration under this subparagraph shall submit such data
   as would be required to obtain registration of a similar pesticide
   under subsection (cX5) of this section: Provided. That, if the appli-
   cant  is unable to submit an item of data because it has not yet been
 -  ?vff nrraied. the Administrator may *«jJneT..o*«mend the jegistjatioc
   of 4he pesticide mufcraiKhcond^^
   of such data not later than the time such data are required to be sub-
   mitted with respect to similar pesticides already registered under this
   Act.
     "(B) The Administrator may conditionally amend the registration
   of a  pesticide to permit additional uses of such pesticide notwith-
   standing that data concerning the pesticide may be  insufficient  to
   support an  unconditional amendment,  if the Administrator  deter-
   mines that (i) the applicant has submitted satisfactory data pertaining
   to the proposed additional use. and (U) amending the registration in
             r piDpBad'i»y*lK.
-------
 Chapter  One
                     FIFRA
                     dietary exposure enumerated in regulations isued under this Act, and
                     during the pendency of any risk-benefit evaluation initiated by such
                     notice, if (i) the  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 the Administrator determines, with
                     the concurrence of the Secretary of Agriculture, there is available an
                     effective alternative pesticide that does not meet or exceed such risk
                     criteria. An applicant seeking  amended registration under this sub-
                     paragraph shall submit such data as would  be tequired to obtain
                     registration of a similar pesticide under subsection (c)(5) of this sec-
                     tion: Provided, That, if the applicant is unable to submit an item of
                     data (other than data pertaining  to the proposed additional  use)
                     because it has not yet been generated, the Administrator may amend
                     the registration under such conditions as will require the submission
                     of such data not later than the  time such data are required to be sub-
                     mitted with respect to similar pesticides already registered under this
                     Act.
                       "(C) The Administrator may conditionally register  a pesticide
                     containing  an active  ingredient not  contained in any  currently
                     registered pesticide for a period reasonably sufficient for the genera-
                     tion and submission of required data (which are lacking because a
                     period reasonably sufficient for generation of the data  has  not
                     elapsed since the  Administrator first imposed the data requirement)
                     on the condition  that by the end of such period the Administrator
                     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 Administrator may  prescribe: Provided,  That a
                     conditional registration under  this subparagraph shall  be granted
                     only if the Administrator determines  that use of the  pesticide during
                     such period will not cause any unreasonable adverse effect on the en-
                     vironment, and that use of the pesticide is, in the public interest.
                     "(8)  Interim administrative review. —Notwithstanding any other pro-
                  vision of this Act, the Administrator may not initiate a public  interim
                  administrative review process to develop a  risk-benefit evaluation of the
                  ingredients of a pesticide or any of its uses prior to initiating a formal
                  action to  cancel, suspend, or deny registration of such pesticide,  re-
                  quired 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 signifi-
                  cant evidence' as used herein shall be published by the Administrator in
                  the Federal Register."
               "(d) Classification of Pesticides.—
                     "(1)  Classification-for general use, restricted use. or both.—
                       "(A) As a part of the registration of a pesticide the Administrator
                     shall classify it as being for general  use or for restricted use. provided
                     that if the Administrator determines that some of the uses for which
                     the pesticide 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 classified by regulation on the initial classification, and registered
                     pesticides may be classified prior  to reregistration. If some of the
                     uses of the pesticide are classified for general use and other uses are
                     classified for restricted use, the directions relating to its general uses
                     shall be clearly separated and distinguished  from those directions
                     relating to  its restricted uses: Provided, however.  That the Ad-
                     ministrator 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 the pesticide, when ap-
                     plied in accordance with its directions for use, warnings and cautions
                     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 frrogniied
                     practice, will not generally cause unreasonable advene effects on the
                     environment,  he will classify the pesticide, or the particular use or
                     uses of the pesticide to which the determination applies, for general
                     use.
                       "(C) If the Administrator determines that the pesticide, when ap-
                     plied in accordance with its directions for use, warnings and cautions
                     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 regulatory restric-
                     tions, unreasonable adverse effects on the environment,  including
      P.L. «-»6.
      92 Sill. 126.
      Notice of
      Definitions.
      Public*! ion in
      Feorrtl Rrjuirr
      P.L. 9i-i9t.
      « Sl»l. 126.
FIFRA Compliance/EnforceBenT
Guidance"
1553

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Chapter  One	     FIFE*
                                   injury to.the applicator, he shall classify the pesticide, or the par-
                                   ticular use or uses to which the determination applies, Tor restricted
                                   use:
                                        "(i) If the Administrator classifies a pesticide, or one or more
                                      uses of such pesticide, for restricted use because of a determina-
                                      tion that the acute dermal or inhalation toxicily of the pesticide
                                      presents a hazard to the applicator or other persons, the pesticide
                                      shall be applied for any use to which the restricted classification
                                      applies only by or under the direct  supervision of a certified ap-
                                      plicator.
                                        "(ii) If the Administrator classifies a pesticide, or one or more
                                      uses of such pesticide, for restricted use because of a determina-
                                      tion that its use without additional regulatory restriction  may
                                      cause  unreasonable  adverse effects on the  environment, the
                                      pesticide shall  be applied for any use to which the determination
                                      applies only by or under  the direct supervision of a certified ap-
                                      plicator, or subject to such other restrictions as the Administrator
                                      may  provide  by regulation.  Any such  regulation  shall be
                                      revtewabie in the appropriate court of appeals upon petition of a
                                      person adversely affected filed within 60 days of the publication
                                      of the regulation in  final  form.
                ..„ ,r              "(2) Change in classification.—If the Administrator determines that
                 i?.Mir           a change in the classification of any use of a pesticide from general use
                                to restricted use is necessary to prevent unreasonable adverse effects on
                                the environment, he shall notify the registrant of such pesticide of such
                                determination at least forty-five days before making  the change and
                                shall  publish the proposed change  in  the Federal  Register.  The
                                registrant,  or other  interested person with the concurrence  of the
                .v_;              registrant,may seek relief from such determination under section 6(b).
           PI «?-.««.:                "(3) Change in ftaaificarioH from restricted me to general use. —The
           *J*"" *"              registrant of any pesticide with one or more uses classified for restricted
                                use  may petition the Administrator to change any such classification
                                from restricted to general use. Such petition shall set out the basis for
                                the registrant's position that restricted use classification is unnecessary
                                because classification of the pesticide for  general use would not cause
                                unreasonable adverse effects on the environment. The Administrator,
                                within sixty days after receiving such petition, shall notify the registrant
                                whether the petition has been granted or denied. Any denial shall con-
                                tain an  explanation therefor and any such denial shall be subject to
           7 UM i.ww,              judicial  review under section 16 of this Act.
                            "(e) Products With Same Formulation and Claims.—Products which have
                          the same formulation, are manufactured by the same person, the labeling of
                          which contains the same claims,  and  the labels  of which bear a designation
                          identifying the product as  the same pesticide may be registered as a single
                          pesticide; and  additional names and labels shall be added to the registration by
                         '".supplemental statements.
                            "
-------
 Chapter  One
                     FIFRA
           "SEC. 4. USE  OF  RESTRICTED  USE PESTICIDES;  CERTIFIED AP-
           PLICATORS.
              "(a) Certification Procedure.—
                   "(1) Federal certification.—In any Stale 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 for the certification of applicators of pesticides: Pro-
                 vided. That such program shall conform to the requirements imposed
                 upon the States under the provisions of subsection (aM2) of this section
                 and shall not require private  applicators to take any examination to
                 establish competency in the use of pesticides. Prior to the implementa-
                 tion of the program, the Administrator shall  publish in the Federal
                 Register for review and comment a summary of the Federal plan for ap-
                 plicator certification 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 hearings shall
                 be held  within thirty days following receipt of the request from the
                 Governor. In any Slate in which the Administrator conducts a certifica-
                 tion program, the Administrator may require any person engaging in the
                 commercial application, sale,  offering  for sale, holding for sale, or
                 distribution of any  pesticide  one or more  uses of which  have  been
                 classified for  restricted use to maintain such records and submit such
                 reports concerning the commercial application, sale, or distribution of
                 such pesticide as the Administrator may by regulation prescribe. Subject
                 to paragraph  (2),  the Administrator shall prescribe standards for the
                 certification of applicators 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 in-
                 dividual's certification: Provided, however. That the certification stan-
                 dard for a private applicator shall, under a State plan submitted for ap-
                 proval, be deemed. fulfilled by his  completing a  certification form.
                 The Administrator shall further assure that such form contains ade-
                 quate 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 Administrator so
                 long as the program does not require the private applicator to take, pur-
                 suant to requirement prescribed by the Administrator, any examination
                 to establish competency in the  use of the pestiscide. The Administrator
                 may require any pesticide dealer participating in a certification program
                 to be licensed under  a State licensing program approved  by him.
                   "(2) Stale 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 sub-
                 mitted by any State,  or any modification thereof,  if such plan in his
                 judgment—
                     4'(A) designates a State agency as  the agency  responsible for ad-
                   ministering the plan throughout the State;
                     "(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 satisfactory assurances  that the State  will devote ade-
                   quate funds to  the administration of the plan;
                     "(D) provides that the State agency will make such reports to the
                   Administrator in such form and containing such information as the
                   Administrator may from time to time require; and
                     "(E) contains satisfactory assurances that State standards for the
                   certification of applicators  of pesticides conform with those stan-
                   dards prescribed by the Administrator under paragraph (I).
                 Any State certification program under this section shall be maintained
                 in accordance with the State plan approved under this section.
             "(b) State Plans.—If the Administrator rejects a plan submitted under this
           paragraph, he shall afford the State submitting the plan due notice and oppor-
           tunity for hearing before so doing. If the Administrator approves a plan sub-
           mitted under this paragraph,  then  such State shall certify applicators of
           pesticides with respect to such State.  Whenever the Administrator determines
           that a State is not administering the certification program in accordance with
           the plan approved under this section, he shall so notify the State and provide
           for a hearing at the request of the State, and, if appropriate corrective action is
                                                                                      i rsr i.v*
      Public
      Standards
      P.L. »4.HO:
      If Siai. 733.
PIPE!
fluidance  Manual 1983

-------
wnapter  One
                                                                          FIFRA
           P.I. V4.I4D.
           14 Sill '?-
           7 USC IJAu
 noi taken within  a reasonable lime, not to exceed ninety days,  the  Ad-
 ministrator shall withdraw approval of such plan.
   "(c) Instruction  in Integrated Pest Management Techniques.—Standards
 prescribed by the Administrator for the certification  of applicators of
 pesticides  under subsection  (a), and the State  plans submitted to the  Ad-
 ministrator under subsection (a) and (b). shall include provisions for making
 instructional materials concerning integrated pest management  techniques
 available to individuals at their request in accordance with the provisions of
 section 23(c) of this Act, but such plans may not require that any individual
 receive instruction concerning such techniques or be shown to be competent
 with respect to the use of such techniques. The Administrator and States im-
 plementing such plans shall provide that all interested individuals are notified
 of the availability of such instructional materials."
           P.L. W-3»6:
           « s»i. at.
           7 USC IM>.
           7 USC 13*.
           7 USC 1Mb.
           P.L. ««-l«h
           WSul. 754.
 "SEC. 5. EXPERIMENTAL USE PERMITS.
.   "(a) Jssuance.-~Aj)y person may .apply to the Administrator for an ex-
 perimental use permit for a pesticide. The Administrator shall review the ap-
 plication. 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
 therefor. The applicant may correct the application or request a waiver of the
conditions for such permit within thirty days of receipt  by the applicant of
such  notification. The Administrator may issue an experimental use permit
only if the Administrator determines that the applicant needs such permit in
 order to accumulate information necessary to register a pesticide under section
 3 of this Act. An application/or .an experimeaiaJ,use permit may.be filed at
any time.
   "(b) Temporary Tolerance Level.—If the Administrator determines that
the use of a pesticide may reasonably be expected to result in any residue on or
in food or feed, he may establish a temporary tolerance level for the residue of
the pesticide before issuing the experimental use permit.
   "(c) Use Under Permit.—Use of a pesticide under an experimental use per-
mit shall be under the supervision of the Adminstrator, and shall be subject to
such terms and conditions and be for such period of time as the Administrator
may prescribe in the permit.
   "(d) Studies.—When any  experimental use permit is issued for a pesticide
containing any chemical or combination of chemicals which has not been in-
cluded in any previously registered pesticide, the Administrator may specify
that studies be conducted to detect whether the use of the pesticide under the
permit may cause unreasonable adverse effects on the environment. All results
of such studies shall be reported to the Administrator before such pesticide
may be registered under section 3.
   "(e) /(evocation.—The Administrator may revoke any experimental use
permit, at any time, if he finds that its terms or conditions are hang violated,
or that its terms and conditions are inadequate to avoid unreasonable adverse
 effects on the environment.
   "(f) State Issuance of Permits.— Notwithstanding the foregoing provisions
 of this section, the Adminsitrator shall.under such terms and conditions as
 he may by regulations prescribe, authorize any State to issue an experimental
 use permit for a pesticide. All provisions of section 4 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 Agencies.—Notwithstanding the
 foregoing provisions of this section, the Administrator nay  issue an ex-
 perimental use permit  for a pesticide to joy public or/private agrioibural
*gse»*caaiency «f>«if»ffan of
                               «ny«Bticide at the end oft h« five-year period which begins on the date
                                of its registration (or at the end of any rive-year period thereafter) unless
                                the registrant, or other  interested person with the concurrence of the
                                registrant, before the end of such period, requests in accordance with
                                                          1-Zo
                                                      Guidance  Manual  1983

-------
Chapter  One
                     FIFRA
                  regulations prescribed by ihe Administrator that the registration be con-
                  tinued in effect: Provided, That the Administrator may permit the con-
                  tinued sale and use of existing stocks of a pesticide whose registration is
                  canceled under this subsection or subsection (b) to such extent, under
                  such conditions, 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 have unreasonable adverse effects on the environment. The Ad-
                  ministrator shall publish in the Federal Register, at least 30 days prior to
                  the expiration of such five-year period, notice that the registration will
                  be canceled if the registrant or other interested person with the concur-
                  rence of the registrant does  not request that  the registration be  con-
                  tinued in effect.
                    "(2) Information.— If at any time after the registration of a pesticide
                  the  registrant   has  additional  factual  information  regarding
                  unreasonable  adverse effects on the environment of the pesticide, he
                  shaJl submit such information to the Administrator.
              "(b) Cancellation and Chance in Classification.—If it appears to the Ad-
            ministrator that a  pesticide or its labeling or other material required to be sub-
            mitted does not comply with the provisions of this Act or when used in accor-
            dance with widespread  and commonly recognized practice, generally causes
            unreasonable adverse effects on the environment, the Administrator may issue
            a notice of his intent either—
                    "(I) to cancel its registration or to change its classification together
                  with the reasons (including the factual basis) for his action, or
                    "(2) to hold a hearing to determine whether or not its registration
                  should be canceled or its classification changed.
            Such notice shall  be sent to the registrant and made public. In determining
            whether to issue any such notice, the Administrator shall include among those
            factors to be taken  into account  the impact of the action proposed in such
            notice on production and  prices of agricultural commodities, retail food
            prices, and otherwise on the agricultural economy. At least 60 days prior to
            sending such notice to the registrant or making public such notice, whichever
            occurs first, the Administrator shall provide the Secretary of Agriculture with
            a copy of such notice  and an analysis of such  impact  on  the agricultural
            economy. If the Secretary comments in writing to the Administrator regarding
            the notice and analysis within 30 days after receiving them, the Administrator
            shall  publish in   the Federal  Register  (with  the  notice) the comments of
            the Secretary and the  response  of the  Administrator with regard  to the
            Secretary's comments. If the Secretary does not comment in writing to the Ad-
            ministrator regarding the notice and analysts  within 30 days after receiving
            them, the Administrator may notify the registrant and make public the notice
            at any time after such  30-day  period notwithstanding the  foregoing 60-day
            time requirement.  The time  requirements  imposed by  the preceding 3
            sentences may be waived or modified to the extent agreed  upon by the Ad-
            ministrator and the  Secretary.  Notwithstanding any other  provision of this
            subsection (b) and section 25(d), in the event that the Administrator deter-
            mines that suspension of a pesticide registration is necessary to prevent an im-
            minent hazard to  human health, then upon such a finding the Administrator
            may waive the requirement of notice to and consultation with the Secretary of
            Agriculture pursuant to subsection (b) and of submission to the Scientific Ad-
            visory Panel pursuant to section 25(d) and proceed in accordance with subsec-
            tion (c).  The proposed action shall become final and effective at the end of 30
            days from receipt by the registrant, or publication, of a notice issued under
            paragraph (1), whichever occurs  later, unless  within (hat time either (i) the
            registrant makes the necessary corrections, if possible, or (u) a request for a
            hearing is made by a person adversely affected by the notice. In the event a
            hearing is held pursuant to such a request or to the Administrator's determina-
            tion under paragraph (2), a decision pertaining to registration or classification
            issued after completion of such hearing shall be final.
              In taking any final action under this subsection,  ihe Administrator shall
            consider restricting a pesticide's use or uses as an alternative to cancellation
            and shall fully explain  the reasons for these  restrictions, and shall include
            among those factors to  be taken into account the impact of such final action
            on production and prices of agricultural commodities, retail food prices, and
            otherwise on (he agricultural economy, and he shall publish in die Federal
            Register an analysis  of such impact.
              "(c) Suspension.—
                    "(1) Order.—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 may, by order, suspend the
                  registration  of the pesticide immediately. No order of suspension may
                  be issued unless the Administrator has issued or at the same time issues
                  notice of his intention to cancel the registration or change the classifica-
                  tion of the pesticide.
      Publication in
      Federal Refiner.
     Hearing
      P.L. 94-140;
      WSlai 751.
      Publication in
     . Federal RettMn.
        C- IJn.
     P.L. «5-I*6:
     RSut.ta.

     P.L. M.I40-.
     •> SMI. 751.
FlFJtA  Cbapllance/lin±orce»enF
Guidance Manual 1983

-------
 Chapter  One
                                                                             FIFRA
         (OSui. )«l:
         II SKI. M.
         5 USC 5)1.
          7 USC IMn.
           Subponu.


           IlUSCapp.
          Except as provided in paragraph (3), the Administration shall notify
        the registrant prior to issuing any suspension order. Such notice shall in-
        clude findings pertaining to the question of 'imminent hazard'. The
        registrant shall then have an opportunity, in accordance with the provi-
        sions of paragraph (2), for  an expedited hearing before the Agency on
        the question of whether an  imminent hazard exists.
          "(2)  Expedite hearing. — If no request for a hearing is submitted to
        the Agency within five days of the registrant's receipt of the notification
        provided for by paragraph (1). the suspension order may be issued and
        shall take effect and shall not be reviewable by a court. If a hearing is re-
        quested, it shall commence within five days of the receipt of the request
        for such hearing unless the  registrant and the Agency agree that it shall
        commence at a later time.- The hearing shall be held in accordance with
        the provisions of subchapter II of title 5, of the United States Code, ex-
        cept that the presiding officer need not be a certified hearing examiner.
        The presiding officer shall  have ten days from the conclusion of the
        presentation of evidence to submit recommended findings and conclu-
        sions 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 ex-
        cept that (i) the order of suspension shall be in effect pending the ex-
        peditious-completion of the remedies provided by that paragraph and
        the issuance of a, final order/on suspension, and (ii) no party other than
        the registrant and the Agency shall  participate except that any person
        adversely affected may file  briefs within the time allotted by the Agen-
        cy's rules. Any person so filing briefs shall be considered a party to such
        proceeding for the purpose of section 16(b).
          "(4)  Judicial review. — A final order on the question of suspension
        following a hearing shall be reviewable in accordance with Section  16 of
        this Act, notwithstanding the fact  that any related cancellation pro-
        ceedings have not been completed.  Petitions to  review orders on the
        issue of suspension shall be  advanced on the docket of the courts of ap-
        peals. Any order of suspension entered prior to a hearing before the Ad-
        ministrator shall  be subject to  immediate review in an action by the
        registrant or other  interested  person with the concurrence  of the
        registrant in an  appropriate district court, solely to determine whether
        the order of suspension was arbitrary, capricious or an abuse of discre-
        tion, or whether the order was issued in accordance with the procedures
       veslaWished by iaw. Tire effect of any order of theowirt will be only to
       stay the effectiveness of  the  suspension order,  pending the  Ad-
        ministrator's final decision  with respect to cancellation  or change in
        classification. This action may be maintained simultaneously with any
        administrative review  proceeding under this section.  The  commence-
        ment of proceedings under this paragraph shall not operate as a stay of
        order, unless ordered by the court.
    "(d) Public Hearings and Scientific Review. — In the event a hearing is re-
  quested pursuant to subsection (b) or determined upon  by the Administrator
  pursuant to subsection (b), such hearing shall be held after due notice for the
  purpose of receiving evidence relevant and  material to the issues raised by the
  objections filed by the applicant or other  interested parties, or to the issues
.  stated by jlne ^Adnumstcatar, *f «he tenures jodted % -the Adnrinistrator
  other .than fey 'the filing 'of objections. Upon a showing >of retevmnce -and
  reasonable scope of evidence sought by any party to a public hearing, the
  Hearing Examiner shall issue a subpoena to compel testimony or production of
  documents from any person. The Hearing Examiner shall be guided by the
  principles of the Federal Rules of Civfl Procedure in making any order for the
  protection of the witness or the content of documents produced and shall
_ order the payment of reasonable fees and expenses as a condition to requiring •
  testimony of the witness. On contest, the subpoena may be enforced by an ap-
  propriate United States district court in accordance with the principles stated
  herein. Upon  the request of any. party to  a public hearing aod when in the
                  'y •or^dciiiable, ;GK Heuim Ex-
                                          c^ « tfosed refer to* Commit-
           Report.


             <
  tee of the National Academy of Sciences the relevant questions of scientific
  fact involved in the public hearing. No member of any committee of the Na-
  tional Academy of Sciences established to carry out the functions of this sec-
  tion shall have a financial or other conflict of interest with respect to any mat-
  ter considered by such committee. The Committee of the National Academy
  of Sciences shall report in writing to the Hearing Examiner within 60 days after
  such referral on these questions of scientific fact. The report shall be made
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                    FIFRA
            public and  shall be considered as part of  the  hearing  record. The Ad-
            ministrator  shall enter into appropriate  arrangements with  the  National
            Academy of Sciences to assure an objective and competent scientific 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 the purposes of this Act. As soon as practicable after completion
            of the hearing (including the report of the Academy) but not later than 90 days
            thereafter, the Administrator shall evaluate the data and reports before him
            and issue an order either revoking his notice of intention issued pursuant to
            this section, or shall issue an order either canceling the registration, changing
            the classification, denying the registration,  or requiring modification of the
            labeling or packaging of the article. Such order shall be based only on substan-
            tial 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
                 registration issued  under section 3(c)(7) of this Act if (A)  the Ad-
                 ministrator, at any time during the period provided for satisfaction of
                 any condition imposed, determines that the  registrant has failed  to in-
                 itiate and pursue appropriate action toward fulfilling any condition im-
                 posed, or (B) at the end of the period provided for satisfaction of any
                 condition imposed, that condition has not been met: Provided,  That the
                 Administrator may permit the continued sale and use of existing stocks
                 of a pesticide whose conditional registration has been canceled under
                 this subsection to such extent, under such conditions, and for such uses
                 as  the Administrator  may specify if the Administrator determines that
              _  such sale or use is not inconsistent with the purposes of this Act and will
                 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 unless during  that time a request for
                 hearing is made by a person adversely affected by the notice. If a hear-
                 ing is requested, a  hearing shall be conducted under subsection  (d) of
                 this section: Provided, That the only matters for resolution at that hear-
                 ing shall be whether the registrant has initiated and pursued appropriate
                 action to comply with the condition or conditions within the time pro-
                 vided or whether the condition or conditions have been satisfied within
                 the time provided, and whether the Administrator's determination with
                 respect to the disposition of existing stocks is consistent with this Act. A
                 decision after completion of such hearing shall be final.  Notwithstand-
                 ing 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 hearing.
              "(0 Judicial Review.—Final orders of the Administrator under this section
            shall be subject to judicial review pursuant to section 16.
      P.L. 95-3%;
      9: Slat. 828.
      Notice.
      ^ USC I36a
                                                                                       7 USC IJ6n.
            "SEC. 7. REGISTRATION OF ESTABLISHMENTS.
              "(a) Requirement.—No person shall produce any pesticide subject to this
            Act or active ingredient used in producing a pesticide subject to this Act in any
            State unless the establishment in which it is produced is registered with the Ad-
            ministrator. The application for registration of any establishment shall include
            the name and address of the establishment and of the producer who operates
            such establishment.
              "(b) Registration.—Whenever the Administrator receives an application
            under subsection (a), he  shall register the  establishment and  assign it an
            establishment number.
              "(c) Information Required.—
                    "(1) Any producer operating an establishment registered under this
                  section shall  inform  the Administrator within 30 days After  it is
                  registered of the types and amounts of pesticides and. if applicable, ac-
                  tive ingredients used in producing pesticides—
                      "(A) which  he is currently producing;
                      "(B) which he has produced during the 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, in-
                  form him of the name and address of any recipient of any pesticide pro-
                  duced  in any registered establishment which he operates.
       7 USC 134.
       P.L. 95-3%:
       92 SIM. 829.
       92 Sut. 129.
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Chapter  One
                                                                          FIFRA
                             "(d) Confidential Records and Information.—Any information submitted
           92 sut. i»         to the Administrator pursuant 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
           • use iJ*»>         subject to the provisions of section  10.
           7 USC IJW


           Rejulaitom.
           P.L. 95-396:
           92 Sill. 129.
"SEC. 8. BOOKS AND RECORDS.

  "(a) Requirements.—The Administrator may prescribe regulations requir-
ing producers to maintain such records with respect to their operations and the
pesticides and devices produced as he determines are necessary for the effec-
tive enforcement of this Act. 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 pesti-
cides or to.a pesticide for which an application for registration 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 of-
fers for sale, delivers or offers for delivery any pesticide or device subject to
this Act,  shall, upon request of any officer or employee of the Environmental
Protection Agency or of any State or political subdivision, duly designated by
the Administrator, furnish or permit such person at all reasonable times to
have access to, and to copy: (I) all records showing the delivery, movement, or
holding of such pesticide or device, including the quantity, the date of ship-
ment and receipt, and the name of the consignor and consignee;  or (2) in the
event of the inability of any person to produce records containing such infor-
mation, ail other records and information relating to such delivery, move-
ment, or  holding of ihe pesticide or.device. Any inspection with respect to any
records and information referred to in this subsection shall  not extend to
financial  data, sales data other than shipment data, pricing data, personnel
data, and research data (other than data relating to registered pesticides or to a
pesticide  for which an application for registration has been filed).
  Before  undertaking an inspection under  this subsection, the officer or
employee must present to the owner, operator, or agent  in charge of the
establishment or other place where pesticides or devices are held  for distribu-
tion or sale, appropriate credentials and a written statement as to the reason
for ihe 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.
           1 USC I3*f
                          "SEC. -9. INSPECTION OF ESTABLISHMENTS. ETC.

                             "(a) In General.—for purposes of enforcing the provisions of this Act, of-
                           ficers or employees duly designated by the Administrator are authorized to
                           enter at reasonable times, any establishment or other place where pesticides or
                           devices are held for distribution or sale for the purpose of inspecting and ob-
                           taining samples of any pesticides or devices, packaged, labeled ,  and released
                           for shipment, and samples of any containers or labeling for such  pesticides or
                           devices.
                             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 xrcdenmis and a wnttensiateraem as to *he,reason for the inspec-
                          Jion, irtrlndmg aaarcmgm as lowt>ethgr,» violation of theiaw is suspected. If
                           no violation is  suspected, an alternate and sufficient reason shall be given in
                           writing. Each  such inspection shall  be commenced and completed  with
                           reasonable promptness. If the officer or employee obtains any samples, prior
                           to leaving the premises, 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 the portion retained. If an analysis is
                           made of such samples, a copy of the results of such analysis shall  be furnished
                           promptly to the owner, operator, or agent in charge.
                             "(b) Warrants.—For purposes of enforcing the provisions of Ibis Act and
                          apofxasnowingtoan officer or court of.competent jurisdiction  that there is
                         •• Tqcott *o Witvr tharthe •provhiom of ttm Act ^iBve^becn violated, 'officers or
                           employees duly designated by the Administrator are empowered to obtain and
                           to execute warrants authorizing—
                                  "(1) entry for Ihe 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
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                                            FLFRA
                  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 in-
                  formation 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.
               "(c) Enforcement.—
                    "(I) Certification of facts to attorney general.—The examination of
                  pesticides or devices shall be  made in the  Environmental Protection
                  Agency or elsewhere as the Administrator may designate for the purpose
                  of determining  from such examinations whether they comply with the
                  requirements of this Act.  If il shall appear from any such examination
                  that they fail to comply  with the  requirements of this Act, the Ad-
                  ministrator shall cause notice to be given to the 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 opi-
                  nion of the Administrator it appears that the provisions of  (his Act have
                  been violated by such person, then the Administrator shall certify (he
                  facts to the Attorney General, with a copy of the results of the analysis
                  or the examination of such pesticide for the institution of a criminal pro-
                  ceeding pursuant to section  I4(b) or a civil proceeding under section
                  I4(a), when (he Administrator determines that such action will be suffi-
                  cient (o effectuate  the purposes of this Act.
                    "(2) Notice not required.—The notice of contemplated proceedings
                  and opportunity to present views set  forth  in  this subsection are not
                  prerequisites  to the  institution of any proceeding by the  Attorney
                  General.
                    "(3)  Warning notices.— Nothing in this Act shall be construed as re-
                  quiring the Administrator to institute proceedings for prosecution of
                  minor violations of this Act whenever he believes that (he public interest
                  will be adequately  served  by a suitable written notice of warning.
                            7 USC IJ6I.
            "SEC.  10. PROTECTION OF TRADE SECRETS AND OTHER INFOR-
            MATION.

               "(a)  In General.— In submitting data required by this Act, the applicant
            may (I) clearly  mark any portions thereof which in his opinion are trade
            secrets or commercial or financial information and (2) submit such marked
            materials separately from other material required to be submitted under this
            Act.
               "(b)  Disclosure.—Notwithstanding any other provision of this Act,  and
            subject  to (he limitations in subsections (d) and (e) of this section  the  Ad-
            ministrator shall not make public information which in his judgment contains
            or relates to trade secrets or commercial or financial information obtained
            from a  person and privileged or confidential, except that, when necessary to
            carry out the provisions of this Act, information  relating to formulas of pro-
            ducts acquired by authorization of this Act may be revealed  to any Federal
            agency consulted and may be revealed at a public hearing or in findings of fact
            issued by the Administrator.
               "(c) Disputes.—If the Administrator proposes to release for inspection in-
            formation which (he  applicant or registrant believes to  be protected from
            disclosure under subsection (b), he shall notify the applicant or registrant, in
            writing,  by certified  mail.  The  Administrator  shall  not  thereafter  make
            available for inspection such data until thirty days after receipt of the notice by
            the applicant or registrant. During this period, the applicant or registrant may
            institute an action in an appropriate district court for a declaratory judgment
            as to whether such information is subject (o protection  under subsection (b).
               "(d)  Limitations.—
                     "(1) All information concerning  the  objectives,  methodology,
                  results, or significance of any test or experiment performed on or with a
                  registered  or previously  registered pesticide or its separate ingredients,
                  impurities, or degradation products,  and any information concerning
                  the cffecis of such pesticide  on  any organism or  (he behavior of such
                  pesticide in (he environment, including, bui not limited to, data on safe-
                  ly to  fish  and wildlife, humans and other  mammals, plants, animals,
                  and soil,  and studies on persistence,  Iranslocation and  fate in the en-
                  vironment, and metabolism, shall  be available for disclosure (o the
                  public: Provided, That the use of such data  for any registration purpose
                  shall be governed by section 3 of this Act:  Provided further, That  this
                  paragraph does not authorize the disclosure of any information that—
                            7 use 13**
                            P.L. 95-396;
                            92 Sut. 130.

                            Informilton.
                            availability
                            10 public.
                            7 USC I36a.
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Chapter One         	                       	   FIFBA
                                     "(A) discloses maufaciuring or quality conirol pfocesses,
                                     "(B) discloses the details of any methods for testing, detecting, or
                                   measuring the quantity of any delibraiely added inert ingredient of a
                                   pesticide, or
                                     "(C) discloses  the  identity  or  percentage  quantity  of  any
                                   deliberately added inert ingredient of a pesticide, unless the Adminis-
                                   trator has first  determined that disclosure is necessary  to protect
                                   against an unreasonable risk of injury to health or the environment.
                                  "(2) Information concerning production, distribution, sale, or inven-
                                tories of a pesticide that is otherwise entitled to confidential treatment
                                under subsection (b) of this section may be publicly disclosed in connec-
                                tion 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 (C) of paragraph (I) or in paragraph  (2) of this
                                subsection, the Administrator shall notify by certified mail the submit-
                                ter of such information of the intent to release such information. The
                                Administrator  may not release such information,  without the submit-
                                ter's  consent, until thirty days after the submitter has been furnished
                                such   notice: Provided,  That where   the Administrator finds that
                                disclosure of information described in clause (A), (B), (C) of paragraph
                                (1) of this subsection is necessary to avoid or lessen an imminent and
                                substantial 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 Administrator finds appropriate.  During such
                               • period the data submitter .may institute an action hi .an appropriate
                                district court to enjoin or limit the proposed disclosure. The court shall
                                give expedited  consideration to any such action. The court may enjoin
                                disclosure, or limit the disclosure or the parties to whom disclosure shall
                                be made, to the extent that—
                                     "(A) in the case of information described in clause (A), (B), or (C)
                                   of paragraph (I) of this subsection, the proposed disclosure is not re-
                                   quired to protect against an unreasonable risk of injury to health or
                                   the environment; or
                                     "(B) in the case of information described in paragraph (2) of this
                                   subsection, the public interest in availability of the information in the
                                   public proceeding does not outweigh the interests in preserving the
                                   confidentiality of the information.
          P.L. 95-3%;          "(e) Disclosure to Contractors.—Information otherwise  protected from
          93 sin. «3i.        disclosure to the public subsection (b) of this section  may be disclosed to con-
                          tractors with the United States and employees of such contractors if, in the opi-
                          nion o/.the Adminisirat or, such .disclosure is flecessary for thesatisfactory per-
                          formance by the contractor of a contract with the United States for the perfor-
                          mance *of work hi connection with this Act and under such conditions as the
                          Administrator may specify. The Administrator shall  require as a  condition to
                          the disclosure of information under this subsection that the person receiving it
                          take such security precautions respecting the information as the Administrator
                          shall by regulation prescribe.
          P.L. 95-3%:          "(f) Penalty for disclosure^ by Federal Employees.—
          97 Sl" "'             """(I) Any officer br~employee of the United States or former officer
                               or employee of  the United States who, by virtue of such employment or
                               official position, has obtained  possession of, or has access  to, material
                               the disclosure of which is prohibited by subsection (b) of this section,
                               .and .who, -knowing lhaidisclosure of such-material is-prohibiied 'fay such
                               subsection, willfully discloses toe material in any manner to any person
                               not entitled to Teceive it, shall be fined  not more than SI0,000 or im-
                               prisoned for not more than one year, or both. Section 1905 of title 18 of
                               the United States Code shall not apply with respect to the publishing,
                               divulging, disclosure, or making known of, or making available, infor-
                               mation reported or otherwise obtained  under this Act.  Nothing in this
                               Act shall preempt  any civil remedy under State or Federal law  for
                               wrongful disclosure of trade secrets.
                                  "(2) For the  purposes of this section, any contractor with the United
                               States who is furnished information as authorized by subsection (e) of
                               tiiis section, or any employee ofany such contractor^ shall be considered
                               to toe an tmployeerof the United States.
          P.L. »$-3%:          "(g) Disclosure to  Foreign and Multinational Pesticide Producers.—
          925)11 •*"•                "(1) The Administrator shall not knowingly disclose information
                                submitted by an applicant or registrant  under this Act to any employee
                                or agent of any  business or other entity engaged in the production, sale,
                               or distribution of pesticides in countries other than the United States or
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Chapter  One
                                                                                                     FIPRA
                in addition to the United States or to any other person who intends to
                deliver such data to such foreign or multinational business or entity
                unless the applicant or registrant has consented to such disclosure. The
                Administrator shall require an affirmation from any person who intends
                to inspect data that such person does not seek access to the data for pur-
                poses of delivering it or offering it for sale to any such business or entity
                or its agents or employees and will not purposefully deliver or negligent-
                ly cause the data to be delivered to such business or entity or its agents
                or employees. Notwithstanding any other provision of this subsection,
                the Administrator may disclose information to any person in connection
                with a public proceeding under law or regulation, subject to restrictions
                on the availability of information contained elsewhere in this Act, which
                information is relevant  to the determination by the Administrator with
                respect to whether a pesticide, or any ingredient of a pesticide, causes
                unreasonable adverse effects on health or the environment.
                  "(2) The Administrator shall maintain records of the names of per-
                sons to whom data are  disclosed under this subsection and the persons
                or organizations  they  represent and  shall inform  the  applicant  or
                registrant of the names and affiliation of such persons.
                  "(3) Section 1001 of title 18 of the United States Code shall apply to
                any affirmation made under paragraph (I) of this subsection.
           "SEC. 11. STANDARDS APPLICABLE TO PESTICIDE APPLICATORS.     ' i'«

             "(a) In General.—No regulations prescribed by (he Administrator for car-
           rying out (he provisions of this Act shall require any private applicator to
           maintain any records or file any reports or other documents.
             "(b) Separate Standards.—When establishing or approving standards for
           licensing or certification, the Administrator shall establish separate standards
           for commercial and private applicators.
•SEC. 12. UNLAWFUL ACTS.

 "(a) In General.—
       "(I) Except as provided by subsection (b), it shall be unlawful  for
     any person in any State lo distribute, sell, offer for sale, hold for sale,
     ship, deliver for shipment, or receive and (having so received) deliver or
     offer to deliver,  to any person —
          "(A) any pesticide which is no( registered under section 3, except
        as provided by section  6(a)( I);
          "(B) any registered pesticide if any claims made for it as a part of
        its distribution or sale substantially differ from any claims made  for
        it as a part of the statement required in connection with its registra-
        tion under section 3;
          "(C) any registered pesticide the composition of which differs at
        the time of its distribution or sale from its composition as described
        in the statement required  in connection with its registration under
        section 3;
          "(D) any pesticide which has not been colored or discolored pur-
        suant to the provisions of section 25(c)(5);
          "(E) any pesticide which is adulterated or misbranded; or
          "(F) any device which is misbranded.
       "(2) It shall be unlawful for any person —
          "(A) to detach, alter, deface, or destroy, in whole or in part, any
        labeling required under this Act;
          "(B) to refuse to keep any records required pursuant to section 8,
        or to refuse to allow the inspection of any records or establishment
        pursuant lo section  8 or 9,  or to refuse  to allow  an  officer  or
        employee of the Environmental Protection Agency to take a sample
      ' of any pesticide pursuant to section 9;
          "(Q to give a guaranty or undertaking provided for in subsection
        (b) which is false in any particular, except that a person who receives
        and relies upon a guaranty authorized under subsection (b) may give
        a guaranty to the same effect, which guaranty shall contain, in addi-
        tion to his own name and address, the name and address of the per-
        son residing in the United States from whom he received the guaran-
        ty or undertaking;
          "(D) to use for his own advantage or to reveal, other than to  the
        Administrator, or officials or employees of the Environmental Pro-
        tection Agency or other Federal executive agencies, or to the courts,
                                                                                         '*•<
                                                                                     7 us<
                                                                                     ' use u<>.
                                                                                     7 use \M.
FIFRA  Compliance/Enforcement
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Chapter  One
                                                                                                      FIFRA
         ^ USf
         7 USC IJAa.
         P.I. 95096;
         92 Slat. 132.
         7 USC IJ6k:

         7 USC I3W.
         7 USC I36c.
         "7 USC" I.We. IW.
         or to physicians, pharmacists, and other qualified persons, needing
         such information for the performance of their duties, in accordance
         with such directions as the Administrator may prescribe, any infor-
         mation acquired by authority of this Act which is confidential under
         this Act;
           "(E) who is a  registrant, wholesaler,  dealer, retailer, or other
         distributor  to  advertise  a produce  registered  under (his Act for
         restricted use without giving  (he classification  of  the product as-
         signed to it under section 3;
           "(F) to make available for use, or to use, any registered pesticide
         classified for restricted use for some or all  purposes other than in ac-
         cordance  with  section   3(d)  and   any   regulations thereunder;
         Provided, That it shall not be unlawful  to sell, under regulations
         issued by the Administrator, a restricted  use pesticide to a person
         who is not  a certified applicator for application by a certified ap-
         plicator;
           "(C) to use any registered pesticide in a manner inconsistent with
         its labeling;
           "(H) to use any pesticide which is under an experimental use per-
         mit contrary to the provisions of such permit;
           "(I) to violate any order issued under section 13;
           "(J)  to violate any suspension order  issued under section 6;
           "(K) to violate any cancellation  of registration of  a pesticide
         under section 6, except as,provided by section 6(a)(l);
           "(L) who is a producer to violate  any of the provisions of section
         7;
         .  "(M) to  knowingly falsify all  or part of any  application for
         registration, application for experimental  use permit, any informa-
         tion  submitted to  (he Administrator pursuant to section  7, any
         records required to be maintained pursuant to section 8, any report
         filed under this Act, or any information marked as confidential and
         submitted (o the Administrator under any provision of this act;
           "(N) who is a  registrant, wholesaler,  dealer, retailer, or other
         distributor to fail to file reports required by this Act;
           "(O) to add any substance to, or take any substance from, any
         pesticide in a manner that may defeat  the purpose of this Act; or
           "(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 mental  health consequences which are
         reasonably foreseeable therefrom, and  (ii) freely volunteer  to par-
         ticipate in the test.
  "(b) Exemptions.—The penalties provided  for a  violation of paragraph (1)
of subsection 
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 Chapter  One
                                            FIFRA
           visions of this Act, or that such pesticide or device has been or is intended to
           be distributed or sold in violation of any such provisions, or when the registra-
           tion of the pesticide has been canceled 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 custody of such pesticide or
           device, and after receipt of such order no person shall sell, use, or remove the
           pesticide or device described in  the order except in accordance with the provi-
           sions of the order.
             "(b) Seizure.—Any pesticide or device that  is being transported or, having
           been transported,  remains unsold or in original unbroken packages, or that 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 any district court in the district
           where it is  found and seized for confiscation by a process in rem for condem-
           nation  if—
                  "(I) in the case of a pesticide—
                     "(A) it is adulterated or misbranded;
                     "(B) it is not registered pursuant to the provisions of section 3;
                     "(C) its labeling fails to bear the information required by this Act;
                     "(D) it is not colored or discolored and such coloring or discolor-
                   ing is required under this Act;  or
                     "(E) any of the claims made  for it or any of the directions for its
                   use differ in substance from the representations made in connection
                  'with its registration;
                  "(2) in the case of a device, it is misbranded; 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
                labeling, it nevertheless causes unreasonable adverse effects on the en-
                vironment. In the case of a plant regulator, defoliant, or desiccant,  used
                in accordance with the label claims and  recommendations, physical or
                physiological effects on plants or parts thereof shall not be deemed to be
                injury when  such effects are the purpose for which the plant regulator,
                defoliant, 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 the 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 tnis Act or the laws of the jurisdiction
          in which it  is sold;  Provided, That upon  payment of the costs of the condem-
          nation proceedings and  the execution and delivery of a good and  sufficient
          bond conditioned  that  the  pesticide or device  shall not be sold or otherwise
          disposed of contrary to  the provisions of the Act or the laws of any jurisdic-
          tion in  which sold, the court may direct  that such pesticide or device be
          delivered to the owner thereof. The proceedings of such condemnation cases
          shall conform, as near as may be to the proceedings in admiralty, except that
          either party may demand trial by jury of any issue of fact joined in any case,
          and ail such proceedings shall be at the suit of  and in the name of the 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 ex-
          penses shall be awarded  against  the person, if any, intervening as claimant of
          the pesticide or device.
           'SEC.  14. PENALTIES.

             "(a)  Civil Penalties.—
                  "(1) In General.—Any registrant, commercial applicator, whole-
                saler, dealer, retailer, or other distributor 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 Applicator.—Any private applicator or other person not
                included in paragraph (I) who violates any provision of this Act subse-
                quent to receiving a written warning from the Administrator or follow-
                ing a citation for a prior violation, may be assessed a civil penalty by the
                Administrator of not more  than SI,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 deliver-
                ing 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
                51,000 for each subsequent offense.
                          1 USC I3M
                           P.I.. V5-J96:
                           n Slal. >32.
FIFRA  Compliance/Enforcement
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Guidance Manual  1983

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 Chapter  One	FUBA
                                  "(3)  Hearing. — No civil penalty shall be assessed unless ihe person
                                charged shall have been given notice and opportunity for a hearing on
                                such charge in the county, parish, or incorporated city of the residence
                                of the person charged.
          P.I . "»5-.m:                 "(4)  Determination  of Penalty.—In determining  the amount  of
          92S'ai *V1               the penalty, the Administrator shall consider the appropriateness of such
                                penalty to the size of the business of the person charged, the effect on
                                the person's ability to continue in business, and the gravity of the viola-
                                tion. Whenever the  Administrator  finds that the violation occurred
                                despite the exercise of due care or  did not cause significant harm to
                                health or the environment, the Administrator may issue a warning in
                                lieu of assessing a penalty.".
                                  "(5)  References to Attorney General.—In case of inability to collect
                                such civil penalty or failure of any person to pay all, or such portion of
                                such civil penalty  as the Administrator  may .determine,  the Ad-
                             .   ministrator shall refer the. matter to the Attorney General,  who shall
                                recover such amount by action in the appropriate United States district
                                court.
                            "(b) Criminal Penalties.—
                                  "(I)  In  General.— Any  registrant,   commercial  applicator,
                                wholesaler, dealer, retailer, or other distributor who knowingly violates
                                any provision of this Act shall be guilty of a misdemeanor and shall on
                                conviction be fined not more than $25,000, or  imprisoned for not more
                                than one year, or both.
                                  "(2)  Private applicator.— Any private applicator or other person not
                                included in paragraph (1) who knowingly violates any provision of this
                                Act shall  be guilty of a misdemeanor and shall on conviction be fined
                                not .more.than il.OOO, 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-
          T use i3oi               quired under the  authority of section 3, shall be fined not more than
                                $10,000, or imprisoned for not more than three years, or both.
                                  "(4)  Acts of officers, agents, etc.—When construing and enforcing
                                the provisions of  this Act, the act, omission, 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 the act, omission, or failure of such per-
                                son  as well as that of the person employed.
          7 use »6»        "SEC. 15. INDEMNITIES.

                            **(a) -Requirement.—If—
                                 "(1) the Administrator notifies a registrant that: he has suspended the
                                registration of a pesticide because such action is necessary to prevent an
                                imminent hazard;
                                 "(2) the registration of the pesticide is canceled as a result of a final
                                determination that the use of such  pesticide will create an imminent
                                hazard; and
                                 "(3) any  person  who owned any quantity of such pesticide  im-
                                mediately before the notice to the registrant under paragraph (I) suf-
                                fered losses by reason of suspension  or cancellation of the registration.
                                The Administrator shall make an indemnity payment to such person,
                                unless the Administrator finds that  such person (i) had knowledge of
                                facts which, in themselves, would  have shown .that such -pesticide did
          7 use 136.            .   not meet 'the requirements of section 3(c)(5) .for registration, and (ii)
                                continued thereafter to produce such  pesticide without giving timely
                                notice of such facts to the Administrator.
                            "(b) Amount of Payment.—
                                 "(I) In General.—The  amount of the indemnity payment under
                                subsection (a) to any person shall be determined on the basis of the cost
                                of the pesticide owned by such person immediately before the notice to
                                the registrant referred to in subsection (a)(l); except  that in no event
                                shall an indemnity payment to any person exceed the fair market value
                                of the pesticide owned by such person immediately before Ihe notice
                               referred to in subsection (aM 1).
                                 "(2) Special ro/e—Notwithstanding any other provision of his Act,
                                the Administrator  may  provide a reasonable time  for use or other
                                disposal of such pesticide. In determining the quantity of any pesticide
                                for which indemnity shall be paid under this subsection, proper adjust-
                                ment shall be made  for any pesticide used or otherwise disposed of by
                                such owner.
FIFRA Compliance/Eoforceaent                 1-36        '.        Guidance Manual  1Q«1

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Chapter  One
                                           FIFRA
          "SEC. 16. ADMINISTRATIVE PROCEDURE; JUDICIAL REVIEW.          7 use ut.

            "(a) District Court Review.— Except as is otherwise provided in this Act,
          Agency refusals to cancel or suspend registrations or change classifications not
          following a hearing and other final Agency actions not committed to Agency
          discretion by law  are judicially reviewable in the district  courts.
            "(b) Review by Court of Appeals.—In the case of actual controversy as to
          the validity of any order issued by the Administrator  following a public hear-
          ing, any person who will be adversely affected by such order and who had 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,  within 60 days after the entry of such order, a petition pray-
          ing that the order  be set aside in whole or in part. A copy of the petition shall
          be forthwith transmitted by the clerk of the court to the Administrator or any
          officer designated 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 fit-      ?:siai. MM
          ing of such petition the court shall have exclusive jurisdiction to affirm or set      nosiai. 1323
          aside the order complained of in whole or in part. The court shall consider all
          evidence of record.  The order pt  the Administrator shall be sustained  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
          part, any order under this section  shall be final, subject to  review by the
          Supreme Court of the United States upon certiorari  or  certification as pro-
          vided in section 1254 of title 28 of the United States Code. The commencement      *: sui  
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 Chapter  One
                                                                            FIFRA
                          right to introduce testimony. If it appears from the examination of a sample
                          that it is adulterated, or misbranded or otherwise violates the provisions set
                          forth in this Act, or is 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 destruction
                          of any pesticide or device refused delivery which shall not be exported by the
                          consignee within 90 days from the date of notice of such refusal under such
                          regulations as the Secretary of Treasury may prescribe:  Provided, That the
                          Secretary of the Treasury may deliver to the consignee such pesticide or device
                          pending examination and decision in the matter on execution of bond for the
                          amount of the full invoice value of such pesticide or device, together with the
                          duty thereon, and on refusal to return such pesticide or device for any cause to
                          the custody of the Secretary of the Treasury, when demanded, for the purpose
                          of excluding them.from the country, or for any other purpose, said consignee
                          shall forfeit the full amount of  said bond: And provided further, That all
                          charges for  storage, cartage,  and  tabor on pesticides or devices which  are
                          refused admission or delivery shall be paid by the owner or consignee, and in
                          default of such payment shall constitute a lien against any future importation
                          made by such owner or consignee.
                            "(d) Cooperation in International Efforts.—The Administrator shall in
                          cooperation with the Department of State and any other appropriate Federal
                          agency, participate and cooperate in any international efforts to develop  im-
                          proved pesticide research and regulations.
                            "(e) Regulations.—The Secretary of the Treasury, in consultation with the
                          Administrator, shall prescribe regulations for the enforcement of subsection
                          (c) of this section.
           1USC 13**
           I'.l . 44-1411:
           K") Siai. 7\4.
 "SEC. 18.  EXEMPTION OF FEDERAL AGENCIES.

   "The Administrator may, at his discretion, exempt any Federal or State
"agency from any provision of (his Act if he deiermines that emergency condi-
 tions exist which require such exemption.
   "The Administrator, in determining whether or not such emergency condi-
 tions exist,  shall consult with the Secretary of Agriculture and the Governor of
 any Stale concerned if they request such determination."
           7 USf Ij6q
           7 use u*d
          KJSial. »44;
          74 Sin. 80S;
          79Siai. 286:
          72Sill. 775:
          15 Sill  4«!.
          Conlravi
          Authority.
 "SEC. 19.  DISPOSAL AND TRANSPORTATION.

   "(a) Procedures.—The Administrator shall, after consultation with other
..interested Federal agencies, establish procedures and -regulations for the
 disposal OT storage of packages and containers of pesticides and for disposal
 or storage of excess amounts of such pesticides, and accept at convenient loca-
 tions for safe disposal a pesticide the registration of which is canceled under
 section 6(c) if requested by the owner of the pesticide.
   "(b) Advice to Secretary of Transportation.—The Administrator shall pro-
 vide advice and assistancr to the Secretary of Transportation with respect to
 his  functions relating to the transportation of hazardous materials under the
 Department of Transportation Act (49 U.S.C.  1657), the Transportation of
 Explosives  Act (18 U.S.C.  831-835), the Federal Aviation Act of  1958 (49
 U.S.C.  1421-1430, 1472 11), and the Hazardous Cargo Act (46 U.S.C. 170.
 375. 416).
   *'(c) ^Vo*roonj/or»vm«s«/OTwnm«.—^Notification of cancellation of any
.•pesticide shaDinciudespedficprovisions for the disposal of the unused quan-
 tities of such pesticide.
           7 use iJ*»
          •M.. »»•»:
          KSui «34.
 "SEC. 20. RESEARCH AND MONITORING.

 "(a) Research.—The  Administrator  shall  undertake  research, including
 research by grant or contract with other Federal agencies, universities, or
 others AS may Jje necessaryto cawy-out Ihe purposes of 4his Act.-and toe shall
 conduct research into .integrated pest iramagrmnil -in -coordination with the
 Secretary of Agricu1ture:The Administrator shall also take care to insure that
 such research does  not  duplicate  research being undertaken  by any other
 Federal agency.
   "(b) National Monitoring Plan.—The Administrator shall formulate and
 periodically revise, in cooperation with other Federal, State, or local agencies,
 a national plan for monitoring pesticides.
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Guidance  Manual  1983

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  Chapter  One
                                           FIFRA
             "(c) Monitoring.—The Administrator shall undertake such monitoring ac-
           tivities, including, but not limited  to, monitoring in air, soil,  water, man,
           plants, and animals, as may be necessary for the implementation of this Act
           and  of  the  national  pesticide monitoring  plan.  The  Administrator  shall
           establish procedures for the monitoring of man and animals and their environ-
           ment for incidental pesticide exposure, including, but not limited  to, the quan-
           tification of incidental human and environmental pesticide pollution and the
           secular trends thereof, and identification of the sources of contamination and
           their relationship to human and environmental effects. Such activities shall be
           carried out in cooperation with other Federal, State,  and local agencies.
                            P.L. 95-396;
                            92 Slai. 8.14.
           "SEC. 21.  SOLICITATION  OF COMMENTS;  NOTICE  OF PUBLIC
           HEARINGS.

             "(a) The Administrator, before publishing regulations under this Act, shall
           solicit the views of the Secretary of Agriculture in accordance  with the pro-
           cedure described in section 25(a).
             "(b) In addition to any other authority relating to public  hearings and
           solicitation  of views, in connection with the suspension or cancellation of a
           pesticide registration or any other actions authorized under this Act, the Ad-
           ministrator  may, at his  discretion, solicit the views of all interested persons,
           either orally or in writing, and seek such advice from scientists, farmers, farm
           organizations, and other qualified  persons as he deems proper.
             "(c) In  connection  with  all  public hearings  under  this Act the Ad-
           ministrator shall publish timely notice of such hearings in the Federal Register.
                            P.L. 94-140;
                            89Slai. 7?2;
                            7 USl I
                           Publication' in
                           Federal Rcxi«cr.
           "SEC. 22. 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 Administrator may
           designate for the  purpose.
             "(b) Cooperation.—The Administrator shall cooperate with the  Depart-
           ment of Agriculture, any other Federal agency, and any appropriate agency of
           any State or any political subdivision thereof, in carrying out the provisions of
           this Act, and in securing uniformity of regulations.
                                                                                      7 USf
           "SEC. 23. STATE COOPERATION, AID, AND TRAINING.

             "(a) Cooperative   Agreements.—The   Administrator  may  enter  into
           cooperative agreements with States and Indian tribes—
                  "(I) 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 facilities, 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
                implementing 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
                prescribes.
             Effective with the fiscal year beginning October 1, 1978, there are author-
           ized to be appropriated annually such funds as may be 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  pro-
           grams during such fiscal year. If funds sufficient to pay SO percent of the costs
           Tor any year are not appropriated, the share of each 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 in-
           to contracts with Federal, State,  or Indian tribal agencies for the purpose of
           encouraging the training of certified applicators.
             "(c) Information and Education.—The Administrator shall, in coopera-
           tion with the Secretary of Agriculture, use the services of the cooperative State
           extension services  to inform and educate  pesticide users about accepted uses
           and other regulations made under this Act.
                                                                                      7 use lit*
                           P.L. »<-J94;
                           92 Slai. 8X
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Guidance Manual 1983

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 Chapter  One	                  	             FIFRA
           7 use .36-         "SEC. 24. AUTHORITY OF STATES.

           PI. »s-3»»:          "(a) A State may  regulate the sale or use  of  any federally registered
           92 sm. 83<.        pesticide or device in the Slate, but only if and to the extent the regulation does
                           not permit any sale or use prohibited by this_Act.
                             "(b) Such Stale shall not impose or continue in effect any requirements for
                           labeling or packaging in addition 10 or different from those required under
                           (his Act.
                             "(c)(l)  A Stale may provide registration for additional  uses of federally
                                 registered pesticides formulated  for distribution and use  within  that
                                 State lo meet special local needs in accord with the purposes of this Act
                                 and if registration for such use has not previously been denied, disap-
                                 proved, or cancelled  by the Administrator. Such  registration shall be
           7 use 13*..               deemed registration  under section 3 for all purposes of this Act, but
                                 shall authorize distribution and use only within such State.
                                   "(2) A registration issued by a State under this subsection shall not
                                 be.effective  for more  than  ninety  days if disapproved by the  Ad-
                                 ministrator within that period. Prior to disapproval, the Administrator
                                 shall, except 35 provided in paragraph (3) of this subsection, advise the
                                 State of the Administrator's intention to disapprove and the reasons
                                 therefor,  and provide the State time to respond. The Administrator shall
                                 not  prohibit or disapprove a registration issued by a State under this
                                 subsection (A) on the basis of lack of essentiality of a pest icide or (B) ex-
                                 cept as provided in paragraph (3) of this subsection,  if its composition
                                 and use patterns are similar to those of a federally registered pesticide.
                                   "(3) In no instance may a State issue a registration for a food or feed
           21 use MI.               use unless there exists a tolerance or exemption under the Federal Food,
                                 Drug, and Cosmetic Aci that permits the residues of the pesticide on the
                                 food or feed. If the Administrator determines that a registration issued
                                 by a State is inconsistent with the Federal Food, Drug, and Cosmetic
                                 Act, or the use of a pesticide under a registration issued by a State con-
                                 stitutes an imminent hazard, the Administrator may immediately disap-
                                 prove  the registration.
                                   "(4) If the  Administrator  finds, in accordance with  standards set
           7 use 136-.              forth in regulations issued under  section  25 of this Act, that a State is
                                 not capable of exercising adequate controls to assure that State registra-
                                 tion under this station will be in accord with the purposes of this act or
                                 has failed to exercise adequate controls, the Administrator may suspend
                                 the authority of the State to register pesticides until such Urge as the Ad-
                                 ministrator is satisfied that the State can and will exercise adequate con-
                                 trols. Prior to any such suspension, the Administrator shall advise the
                                 State of  the  Administrator's intention  to suspend and the  reasons
                                 therefor and provide the State time to respond.".
           7 use i»-         -SEC. 25. AUTHORITY OF ADMINISTRATOR.

           r. L. *M40:           "(a)(l) Regulations. — The Administrator is authorized in accordance with
           *9'1"' 5I              the procedure described in paragraph (2), to  prescribe regulations to
                                carry out the provisions of this Act. Such regulations shall take into ac-
                                count  the difference in concept and usage between various classes of
                                pesticides and differences in environmental risk  and the appropriate data
                                for evaluating such  risk  between agricultural  and  nonagricultural
                                pesticides.
                                     •"(A) PraposedmguiaiiamSi~At:ieasti60 days prior to signing any
                                   .proposed regulation for publication in the Federal Register, the Ad-
               ilRlnVin              ministrator shall provide the Secretary of Agriculture with a copy of
                 cjwn.              suc^ regulation. If the Secretary comments in writing to the Ad-
                                   ministrator regarding any such regulation within 30 days after receiv-
                                   ing it,  the Administrator shall publish in the Federal Register (with
                            ,-      the proposed regulation) the comments of the  Secretary and the
               1! «j*'                response of the Administrator with regard to the Secretary's com-
                                   ments.._lf_thc Secretary does not  comment in writing to the Ad-
                                   ministrator regarding the regulation within 30 days after receiving it,
                                   the Administrator may sign such regulation for publication in the
                                   federal Register anytime after such JCMlay period notwithstanding
                                   -the •foregoingr^O^day >iinie requirement .
                                     "(B) Final regulations. — At  least  30 days prior  (o signing any
                                   regulation in final form for publication  in the Federal Register, the
           Pubiiiiiion in                Administrator shall provide the Secretary of Agriculture with a copy
           F«i«ai Rrtiue>              qfjuch regulation. If the Secretary comments in writing to the Ad-
                                   ministrator regarding any such final regulation within  15 days after
                                   receiving it,  the Administrator shall publish in the Federal Register



FIFRA Compliance/Enforcement                 1-40                 Guidance  Manual  1983

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Chapter  One
                                          FIFRA
                   (with the final  regulation)  the  comments of the Secretary, if re-
                   quested by the Secretary, and the response of the Administrator con-
                   cerning the Secretary's comments. If the Secretary does not comment
                   in writing to  the Administrator regarding the regulation  within 15
                   days after receiving it, the Administrator may sign such regulation
                   for publication in the Federal Register at any time after such 15-day
                   period notwithstanding the  foregoing 30-day time requirement.
                     In taking any final action  under this subsection, the Administrator
                   shall include among those factors to be taken into account the effect
                   of the  regulation on  production  and  prices of agricultural com-
                   modities, retail  food prices,  and otherwise  on the  agricultural
                   economy, and the Administrator shall publish in the Federal Register
                   an analysis  of such effect.
                     "(C) Time requirements. — The  time requirements imposed by
                   subparagraphs (A) and (B) may be waived or modified to  the extent
                   agreed upon by the Administrator and  the Secretary.
                     "(D) Publication in  the federal  register.— The  Administrator
                   shall, simultaneously  with  any notification to the  Secretary of
                   Agriculture under this paragraph prior to the issuance of any  pro-
                   posed or final regulation, publish  such notification in the Federal
                   Register.".
                   "(3) Congressional Committees.— At such time as the Administrator
                is required  under paragraph  (2)  of  this  subsection to provide  the
                Secretary of Agriculture with a copy of proposed regulations and a copy
                of the final  form of regulations, he shall  also furnish a copy of such
                regulations to the Committee on Agriculture of the House of Represen-
                tatives and the Committee on Agriculture and Forestry of the Senate."
           "(4)  RULE AND REGULATION REVIEW. —
           "(A) CONGRESSIONAL  REVIEW. — Notwithstanding any other provision of this
         Act, simultaneously with  promulgation  of any rule or regulation under this Act,
        • the- Administrator shall transmit a copy thereof to the Secretary of the Senate and
         the Clerk of the House of Representatives.  Except  as provided in subparagraph
         (B), the rule or regulation shall not become effective, if within 90 calendar days of
         continuous session of Congress after the dare of promulgation, both Houses of
         Congress  adopt a concurrent  resolution, the matter after the resolving clause of
         which  is  at follows: "That  Congress disapproves  the  rule or regulation pro-
         mulgated by the Administrator of the Environmental Protection Agency dealing
         with the flatter  of               ,  which rule  or regulation was transmitted to
         Congress on               ,  the blank  spaces therein being appropriately filled.
                            [Added  by PL 96-539, Dec.  18, 1980]
           "(B)  EffECTrvE DATE.  — If at the end of 60 calendar days of continuous ses-
         sion of  Congres* after the date of promulgation of a rule or regulation, no com-
         mittee of either House of Congress has reported or been discharged from further
         consideration of a concurrent resolution disapproving the rule or regulation,  and
         neither House has adopted such a resolution, the rule or regulation may go into ef-
         fect immediately. If, within such 60 calendar days, such a. committee- has reported
         or bear discharged  from further  consideration of  such a resolution, or  either
         House has adopted such a resolution, the rule or regulation may go into effect not
         sooner than 90 calendar  days of  continuous session of Congress after its pro-
         mulgation unless disapproved  as provided in subparagraph (A).
                            [Added by PL  96-539,  Dec. 17, 1980)
           "(Q  For the purposes  of subparagraphs (A) and (B) of this paragraph—
                            [Added by PL  96-539, Dec. 17, 1980]
              "(i) continuity of  session is broken only by an adjournment of Congress
            sine die;, and
                              [Added by PL 96-539, Dec.-17, 1980]
              "00_- the days  on, which either House is  not in- session because of an ad-
           . jounnnent of more than 3 days R> a day certain are excluderf in the computa-
            tion ofc 60 and 90 calendar days, of continuous session of Congress.
                              [Added by PL 96-539, Dec.  17, 1980)
           "(D)  EFFECT OF CONGRESSIONAL INACTION. — Congressional inaction on or re-
         jection of * resolution of disapproval shall not be deemed an expression of ap-
         proval of such rule.
                            [Added by PL  96-539,  Dec. 17, T980]
           "(E)  JUDICIAL REVIEW.—
              "(D Any  interested party, including any person who participated in  the
          . rulemaking. involved, may institute such actions in the appropriate district
            court of the United  States, including actions for declaratory judgment, as
          ., may be appropriate to construe the constitutionality of any provision of this
           •• paragraph. The district court immediately shall  certify all questions of the
            constitutionality of this paragraph to the United States court of appeals for
            the. circuit involved, which shall  hear the. matter sitting en bane.
                              [Added by PL 96-539, Dec.  17, 1980]
                          P.L. 95-396;
                          92 Slal. 836.
                          Publication in
                          Federal Refisier.
                          P.L. 9*-l40;
                          89Siai. 733.
FIFRA Compliance/Enforcement
1-41
Guidance  Manual 1983

-------
 Chapter One
                                                                                 FIFRA
     MSiai. 1670.
     15 USC' 1471 nolc.
    P.L. M-144
    »» Stot. 75*
    T USC IMd.
    r usc u«w.
1»BkUn*to» la
   PabUemdoKln
           m
       "(h> Notwithstanding any other provision of law, any decision on a matter
     certified under clause (i) of this subparagraph shall be reviewable by appeal
     directly to the Supreme Court of the United  Stales. Such appeal shall  be
     brought not later than 20 days- after the decision of the court of appeals.
                       (Added.by PL 96-539. Dec.  IT, 1980]
    "  "(iii) It shall be theduty of the court of appeals and of the Supreme Coun
     of the United States to advance on the docket and to expedite to the greatest
     possible extent the disposition of any matter certified under clause (i) of this
     subpangraph.
                       (Added, by PL 96-539, Dec.  17. 1980]

     "(b) Exemption  of Pesticides.—The  Administrator may exempt  from the
   requirements of this Act by regulation any pesticide which he determines either
   (I) to  be adequately regulated by another Federal agency, or (2) to be of a
   character which is unnecessary to be subject to this Act in order to carry out
   the purposes of this Act.
     "(c)  Other Authority.— The Administrator, after notice and opportunity
   for hearing,  is authorized—
           '•(I)  to declare a pest any  form of plant or animal life (other  than
        man and other than bacteria, virus, and other micro-organisms on or in
        living man or other living animals) which is injurious to health or the en-
        vironment:
           "(2)  to determine any pesticide  which  contains any  substance  or
        substances in quantities highly toxic to man;
           "(3)  to establish standards (which shall be consistent with  those
        established under the authority of  the Poison Prevention Packaging Act
        (Public Law 91-601)) with respect to the package, container,  or wrap-
        ping in which a pesticide or device is enclosed for use or consumption, in
        order to  protect  children  and  adults  from  serious injury  or  illness
        resulting from accidental ingestion or contact with pesticides or devices
        regulated by this Act as well as to accomplish the other purposes of this
        Act;
           "(4)  to specify those classes of  devices which shall be subject  to any
       •provision  of paragraph 2(q)(l) or  section 7 of this Act upon his_deter-
        mination that application of such provision is necessary lo effectuate the
        purposes of this Act;
           "(5)  lo prescribe regulations requiring any  pesticide lo be colored or
        discolored if he determines that  such requirement is feasible  and is
        necessary  for the protection of health and  the environment; and
           "(6)  to determine and establish suitable  names lo be used in  the in-
        gredient statement.               	      	
   "(d) SCIENTIKU: ADVISORY PANEL.—The Administrator  shall submit to an
 advisory panel for comment 3N to the impact on health and the environment
 of the action  proposed til  notices of intent  issued  under section 6(b)  and
 of the proposed and finul  form of regulations issued under section- 25(a)
 within the same time periods as provided for the  comments of the Secretary
 of Agriculture under such sections. The time- requirements for notices  of
 intent and proposed  and fin:il forms of  regulation  may not be  modified  or
 waived unless in  jddition lo mccimg the  requirements  of section  6(6)  or
,25(a>.  as-applicable, the  advisory panel  has .failed to comment on the
;proppNcd- action within the prescribed  time  period or has  agreed to the
 modification, or waiver. The Administrator shall also solicit from  the advisory
 panel comments, evaluations, and recommendations for operating guidelines to
 improve the effectiveness and quality of scientific analyses made by personnel of
 the Environmental Protection Agency that  lead to decisions by the Administrator
 in carrying our the provisions of this Act. The comments, evaluations, and. recom-
 mendations of the advisory panel and the response of the Administrator shall  be
 published in the Federal Register in the same mariner as provided for publication of
 of the comments of the Secretary of Agriculture under such sections. The chairman
 of the advisory panel, after consultation- with the Administrator, may create tem-
 porary subpanels on-specific projects to assist-the full-advisory .panel in expediting

 mayoe;compo«gd of »aiiBiy other than- members  of the advisory 'panel, as
 deemed  necessary for the purpose of evaluating scientific studies relied upon by
 the Administrator with respect to proposed action_Such additional scientists shall
 be selected by the advisory panel. The panel referred to in  this subsection shall
 consist of seven- members appointed by  the  Administrator from a list of 12-
 nommees, six nominated by the National Institutes of Health, and six by the Na-
 tional-Science Foundation-. The  Administrator may require such information from
 the nominees- to the advisory panel as he deems necessary, and he shall publish in
 the Federal Register the name,  address,  and professional affiliations of each
 nominee. Each member of the panel shall receive per diem compeatauonai-a-raie
 n«,in excess of that fixed for GS-18 of the GeneralScntdUJe as may be determined
 toy-the AdmmisTTator^cttgpr that .any ••such- member *«mo holds another office or
 position under the Federal Government the compensation for which exceeds such
 rate may elect to receive compensation at the rate provided for such other office or
 position in lieu of the compensation provided by this subsection. In order to assure
 the objectivity of the advisory panel, the Administrator shall promulgate regula-
 tions regarding conflicts of interest with respect to the members of the panel. The
 TXFRA Compliance/Enforcement
                                       1-42
Guidance Manual  1983

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 Chapter  One
                                            FLFEA
         advisory  panel established under this subsection shall terminate September 30,
         1981. In performing the functions assigned by this Act; the panel shall consult and
         coordinate its activities with the Science Advisory Board established under the En-
         vironmental  Research, Development, and Demonstration- Authorization  Act  of
         1978. Whenever the Administrator exercises authority under section 6(c) of this-
         Act to immediately suspend  the- registration' of  any pesticide to prevent  an im-
         minent hazard, the Administrator shall promptly submit to the advisory panel for
         comment, as to the impact on health and trie-environment, the action taken to sus-
         pend the-registration- of such pesticide.
                           [Amended by PL 96-539; Dec. 17, 1980f
           "(e)  PEER REVIEW. —The Administrator shall, by written procedures, provide
         for peer review with" respect to the-design, protocols, and conduct of major, scien-
         tific studies conducted under this Acr by the Environmental Protection Agency or
         by any other Federal agency, *ny State or political subdivision thereof, or any in-
         stitution  or individual under grant, contract, or cooperative agreement from  or
         with the  Environmental  Protection Agency.  In  such  procedures,  the  Ad-
         ministrator shall also provide for peer review, using the advisory panel established
         under subsection (d) of this section or appropriate experts appointed by the Ad-
         ministrator from a current list of nominees maintained  by such panel, with respect
         to the results of any such scientific uudies relied upon by the Administrator with
         respect to actions the Administrator may take relating to the change in classifica-
         tion, suspension, or cancellation of a pesticide: Provided, That whenever the Ad-
         ministrator determines that circumstances do not permit the peer  review of the
         results  of any  such scientific  study prior  to the  Administrator's  exercising
         authority under section 6(c) of this Act to immediately suspend the 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  documentation  constituting the peer review that relate to
         the proposed scientific studies and  the results of the completed scientific  studies
         shall be included in the submission  for comment forwarded by the Administrator
         to the  advisory panel as provided in  subsection (d). As used in this subsection,
         the term  'peer review' shall mean an independent evaluation by scientific experts,
         either within or outside the Environmental Protection  Agency, in the appropriate
         disciplines."
                             [Added by PL 96-539, Dec. 17, 1980]
           {Editor's note: Section 2(b)  of  PL 96-539 provides:
           "(b) The provisions of this jection shall become effective upon publication in the
         Federal Register of final procedures for peer review as-provided in this section, but
         in no event shall such provision* become  effective later than one year after the date
         of enactment of thi» ACL")
                                  Advtaory p*ncl.
                                  (ernuuiton.
                                  42 USC 4365.


                                  1 USC 136d.
                                 7 USC 13M.
                                 Comments.
                                 "P«r revkw."
                                 r*Mk»0Mii
                                 Fedenl
                                 7 USC 13*- WM«.
           "SEC. 26. STATE PRIMARY ENFORCEMENT RESPONSIBILITY.

             "(a) For the purposes of this Act, a State shall have primary enforcement
           responsibility for pesticide use violations during any period for which the Ad-
           ministrator determines that such State—
                   "(1)  has adopted adequate pesticide use laws and regulations; Pro-
                 vided, That the Administrator may not require a Stale to have pesticide
                 use laws that are more  stringent than this Act;  .
                   "(2)  has adopted and  is implementing adequate procedures for the
                 enforcement of such State laws and regulations: and
                   "(3) will  keep such records and  make such  reports showing  com-
                pliance  with paragraphs (1) and (2)  of this subsection as  the Ad-
                ministrator may require by regulation.
             "(b) Notwithstanding the provisions of subsection (a) of this section, any
          State that enters into a cooperative agreement  with the Administrator under
          section 23 of  this  Act for  the enforcement of  pesticide use restrictions shall
          have the primary enforcement responsibility for pesticide use violations. Any
          State that has a plan approved by the Administrator in accordance with the re-
          quirements of section 4 of this  Act that the Administrator determines meets
          the criteria set out in  subsection (a) of this section shall have the primary en-
          forcement responsibility  for pesticide use  violations. The Administrator shall
          make such determinations  with  respect to Slate plans under Section  4 of (his
          Act in effect on September 30, 1978 not later than March31. 1979.
             "(c)  the Administrator shall  have  primary enforcement responsibility for
          those States that do not have primary enforcement responsibility under this
          Act. Notwithstanding the provisions of section 2(e) (I)  of this Act, during any
          period  when the Administrator has such  enforcement responsibility, section
          8(b)of this Act shall apply to the books and records of commercial applicators
          and to any applicator who holds or applies pesticides, 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 the establishment  or other place where pesticides or devices are held
          for application by such persons with  respect  to pesticides  or devices held for
          such application.
                                 7 USC I34--I
                                  P.L. 95-396;
                                  92Sui 836.
                                  7 USC IM.u
                                  7 USC' IJAb
                                  7 USC 136


                                  7 USC I3«f




                                  7 USC IJ6f
FIFBA Compliance/Enforcement
1-43
Guidance Manual  1983

-------
Chapter  One
                                                                            FIFRA
  7 USC IJ6--J
  P.L. 95-3%:
  9: Slai. 637.
  7 USC 136».|
  7 USC IJ6..J
  P.I.. 9JO%:
  92 Siai.-XM.
  7 use ij6»-<
 P.I. V«-J%-
 92 Slat. 838

 7 USC IJ6a
 7 use I
   PL 94-109
   89 Stot 5-Tt-
    t» Sta*. TU

   7  USC  1M*.
  PL 96-539-
  94 Stat. 3194.
  "SEC. 27. FAILURE BY THE STATE TO ASSURE ENFORCEMENT OF
  STATE PESTICIDE USE REGULATIONS.
    "(a) Upon receipt of any complaint or other information alleging or in-
  dicating a significant violation of the pesticide use provisions of this Act, the
  Administrator shall refer the matter to the appropriate State officials for their
  investigation of the matter consistent with the requirements of this Act. If,
  within thirty days, the State has not commenced appropriate enforcement ac-
  tion, the Administrator may act upon the complaint or information to the ex-
  lent authorized under this Act.
    "(b) Whenever the Administrator determines that  a State having primary
  enforcement responsibility for pesticide use violations is not carrying out (or
  cannot carry out due to the lack of adequate legal authority) such responsibili-
  ty, the Administrator shall notify the State. Such  notice shall specify  those
  aspects of the administration of the State program  that are determined to be
  inadequate. The State shall have ninety days after receipt of the notice to cor-
  rect any deficiencies. If after that time the Administrator determines that the
  State program remains inadequate, the Administrator may rescind,  in whole
  or in pan, the State's primary enforcement responsibility for pesticide use
  violations.
    "(c) Neither section 26 of this Act nor this section shall limit the authority
  of the Administrator to enforce  this Act, where the Administrator determines
  that emergency conditions exist that require immediate action on the part of
  the Administrator and the State authority is unwilling or unable adequately to
  respond to the emergency.
  "SEC.  28.  IDENTIFICATION  OF PESTS;  COOPERATION  WITH
  DEPARTMENT OF AGRICULTURE'S PROGRAM.
    "The Administrator, in coordination with the Secretary of Agriculture,
  .shall .identify those pests  that must  be  brought under control.  The Ad-
  ministrator shall  also  coordinate  and cooperate  with  the Secretary  of
  Agriculture's research and implementation programs  to develop and improve
  the safe use and effect ix-cucvs of chemical,  biological,  and alternative methods
  to combat and control pests that reduce the quality and economical produc-
  tion  and distribution of agricultural products to domestic  and foreign con-
  sumers.
  "SEC. 29. ANNUAL RKPORT.
    "The  Administrator  shall  submit an annual report  to Congress before
  February 16 of each year and the first  report shall  be due February 15,  1979.
  The  report shall include  the total number of applications for conditional
  registration under section 3(c)(7)(B) and 3(c)(7)(C) of this Act that were filed
  during the immediately  preceding fiscal year, and, with respect to  those ap-
  plications approved, the Administrator shall report the Administrator's find-
  ings  in each case, the conditions imposed and any modification of such condi-
  tions in each case, and the quantities produced of such pesticides.
  "SEC. 30. SEVERABILITY.
   "If any provision of this Act or the application thereof to any person or cir-
  cumstance .h:held invalid', the-invalidity shall 'not affect other provisions or ap-
  plications of this Act which can be given effect without regard to the invalid
  provision or  application,  and to this end the provisions of this Act are
  severable.
 -SEC. 3n AUTHORIZATION FOR" APPROPRIATIONS.
  ••There- is. authorized, to- be appropriated- such- sums as may  be  necessary
 to carry out the provisions of" this Act for each of.  the fiscal years  ending
 June .10:  197.1, June 30,  1974., and June 30.  1975: The amounts, authorized
 to be appropriated  for any fiscal-year  ending after June 30. 1975. shall be
 the sums, hereafter provided by law."
  Tierc i» hereby auxhorizcd to-be approprmted to carry out Use-provisions
of Ais. Act -for the period beginning July J-H975. and 'ending September 30,
 1975, the sum of SI 1,967,000.

  There is hereby authorized to be appropriated to carry out the provisions
 of this Act for  the period beginning October 1,. 1975, and ending- November
 15. 1975; thesum-of $5,983400.
  There are hereby authorized  to be appropriated fo~"carry oufthe proviT
stora of  this Act for the period beginning- October 1.  1975. and ending
September 30. 1976-. the sum ofS47.868.OfX), and for the period beginning October 1,
 1976-. and ending-September 30. 1977, the sum of $46,636.000. .and for the period
         -October 1. 1977, and rending  September  30. 1978.  the sum  of
$54^00. OX»..antt for The period beginning October i; V978. and ending Septem-
ber 30, 1979, such- sums as may be necessary, but not in excess of $70.000.000.
   There are hereby authorized to be appropriated tocarry out theprovisions of this
Act for the period beginning October I, 1979, and ending September 30, 1980,
such sums as may be necessary, but not in excess of 572,160,000, and for the
period beginning October 1, 1980, and ending September 30, 1981, such sums as
may be necessary, but not in excess of 777,500,000.". <
FIFRA  Compliance/Enforcement
                                  1-44
Guidance  Manual  1983

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Chapter  One
                                          FIFRA
                               Amendments to Other Acts

           Sec. 3.  of P.L. 92-516 (1972) stales. The following Acts are  amended by
         siriking out the  terms "economic poisons"  and "an economic poison"
         wherever  they  appear and  inserting  in  lieu  thereof "pesticides"  and  "a
         pesticide" respectively:
                (1) The Federal Hazardous Substances Act, as amended (15 U.S.C.
              1261 et seq.);
                (2) The Poison Prevention Packaging Act, as amended (15 U.S.C.
              1471 et seq.); and
                (3) The Federal Food, Drug,  and Cosmetic Act, as amended (21
              U.S.C. 301 et seq.).
                          Effective Dales of Provisions of Act

          Sec. 4. of P.L. 92-516 (1972), as amended, states, (a) Except as otherwise
        provided in  the  Federal Insecticide, Fungicide, and Rodenticide Act,  as
        amended by this Act, and as otherwise provided by this section,  the amend-
        ments made by this Act shall take effect at the close of the date of the enact-
        ment of this Act, provided if regulations are necessary for the implementation
        of any provision that becomes effective on the date of enactment, such regu-
        lations shall be promulgated and shall become effective within 90 days from
        the date of enactment of this Act.
          (b) The  provisions of the Federal Insecticide, Fungicide, and  Rodenticide
        Act and the regulations thereunder as such existed prior to the enactment of
        this Act  shall remain in effect until superseded  by the amendments made by
        this Act  and regulations thereunder.
          (c)(l)  Two years after the enactment of this Act the Administrator shall
             have  promulgated regulations  providing  for   the  registration  and
             classification  of  pesticides  under  the  provisions  of this Act  and
             thereafter shall register all new applications under such provisions.
               (2) Any requirements that a pesticide be registered for use only by a
             certified applicator shall not be effective until five years from the date of
             enactment of this Act.
               (3) A period of five years from date of enactment  shall  be provided
             for certification of applicators.
                  (A) One year after  the enactment of this  Act the Administrator
                shall have  prescribed the  standards  for  the certification  of  ap-
                plicators.
                  (B)  Each State desiring to certify applicators shall submit a State
                plan to the Adminstrator for the purpose provided by section 4
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 Chapter  One
                                                                                    FLFRA
                    CONGRESSIONAL RECORD:
                      Vol. 117 (1971):     Nov. 8. 9. considered and passed House.
                      Vol. 118 (1972):     Scpl. 26, considered and passed Senaie, amended.
                                       Oci. 5, Senaie agreed 10 conference report.
                                       Oci. 12. House agreed 10 conference report.
                    WEEKLY COMPILATION OF PRESIDENTIAL  DOCUMENTS:
                      Vol. 8, No. 44 (1972): Oct. 21. Presidential siaiement.
                                                 P>Mto Ij- *4-l40
                                               Mlk Co*«m3. H. R. U4I
                                                 Notrmbrr Zl. I'15

                    HOUSE REPORTS: No. 94-497 (Comm. on Agriculture) and NO. 94-668 (Comm.
                                     of Conference).
                    SENATE REPORT No. 94-452 (Comm. on Agriculture and Forestry).
                    CONGRESSIONAL RECORD:  Vol. 121 (1975).
                      Sept. 26. Oct. 3, 9, considered and passed House.
                      Nov. 12; considered and passed Senate, amended.
                      Nov. 18, House agreed to conference report.
                      Nov. 19, Senate agreed to conference report.
                                                 PvMIc U»
                                                fllk C».t'm. S. 1*71
                                                 S»»H»tti 31. If 71

                    HOUSE REPORTS: No. 95-343 and No. 95-343, Pt. 2, (Comm. on Agriculture) both
                                     accompanying H.R.  7073 and No. 95-1560 (Comm.  of Con-
                                     ference).
                    SENATE-REPORTS: .No. 95-334 (Comm. on Agriculture. Nutrition and-Forestry) and
                                      95-11*8 (Comm. of Conference).
                    CONGRESSIONAL RECORD:
                      Vol. 123 (1977): July 29, considered and  passed Senaie.
                                   Sept. 22, Oct. 31, considered and passed House, amended, in lieu of
                                   H.R. 7073.
                      Vol. 124 (1978): Sept. 18, Senaie agreed to conference report.
                                   Sept. 19, House agreed lo conference report.
                    WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS:
                      Vol. 14, No. 40: Oct. 2, 1978, Presidential statement.
                     The following is Section 27(a) of P.L. 95-396, the "Federal Pesticide Act of 1978",
                    but is not an amendment to FIFRA.
7 USt I36«.J
Rcporl lo
congressional
commincc.
  Rcpon lo
  conprc\Mim;
  conimiiux.
                                 Studies

   Sec..21. 
-------
Chapter One
4     FIFRA  Regulatory  Elements
 FIFRA was enacted by Congress to provide for the pre-market  clearance of
 pesticides  and the post-market surveillance of pesticides  and pesticidal
 devices.   The following sections of this chapter discuss  the primary
 regulatory  means  by  which the Act is implemented.  The primary regulatory
 elements  of FIFRA include:

     •  Registration of Pesticides;

     •  Establishment Registration;

     #  Pesticide Disposal;

     •  Experimental Use Permits;

     «  Emergency Exemptions  for Federal and State  Agencies; and

     •  State Registration of Pesticides To  Meet Local Needs.
FIPRA Compliance/Enforcement1-47'Guidance Eternal 1983

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 Chapter  One    	  FIFRA Regulatory Elements
MJfKA tompl±ance/JSQ±orcement             P58          Guidance Manual  1983

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Chapter One
4a     Registration  of  Pesticides
The basic element  of  EPA's pesticide regulation  program is the registration
of pesticides destined for use in the United  States.   Section 3 of FIFRA
and 40 C.F.R. Part 162 provide the basic authority  for the registration
program.

The objectives of  the pesticide registration  program are to:

     e  Bring the  product into compliance with Section 3 of the Act;

     •  Provide users with pesticides that will  not cause unreasonable
        adverse effects to the environment when  used as directed;

     •  Provide users with pesticides that will  be  effective for the pur-
        poses listed on the label;

     •  Provide users with pesticides that are essentially safe when used
        as directed;

     •  Identify the registrant and/or producer  responsible for the pesti-
        cide ; and

     •  Identify registered pesticides in the event that enforcement action
        is required.
Applicability of Registration Requirements	


The Act requires that all producers  (see  Glossary) of pesticides have  their
products registered with EPA.

With few exceptions, it is unlawful  for any person in any State to sell,
offer for sale, hold for sale, ship,  deliver for shipment, or receive  and
(having so received) deliver or offer to  deliver to another person any
pesticide that is not registered.
FIFRA Compliance/Enforcement             1-49          Guidance Manual  1983

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 Chapter One	   	      	Registration of Pesticides
A  pesticide may be registered by the Administrator if it is determined
that:

     •   The composition of the product warrants the proposed claims made
         for it;

     •   Its labeling and other required material comply with the require-
         ments  of the Act;

     •   The product will perform its intended functions without unreason-
         able adverse effects to the environment; and

     •   The product will not generally cause unreasonable adverse effects
         to  the environment when used in accordance with widespread and
         commonly recognized practices.

Registered  pesticides will be classified as either "general" or "restric-
ted," according to use.


'Pesticides  Exempt 'From Registration Requirements

The following  pesticides are exempt from registration requirements under
FIFRA [40 C.F.R. §162.5(b)j:

     •   Pesticide products that are offered solely for human use and are
         also either a new drug within the meaning of the Federal Food,
         Drug,  and Cosmetic Act or an article determined not to be a new
         drug by the FDA through a regulation establishing conditions for
         the article's use;

     •   Pesticides being .transferred .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 estab-
         lishment;

     •   Pesticides being transferred for use in accordance with the
         requirements of  an experimental use permit;

    • *+  ,*efitieities-whose registrationis cancelled .under Section 6(c) of
        : tae .Act and .are  shipped solely for disposal-;

     •   Pesticide products Intended for export  to any foreign country when
         prepared or packaged according to the specifications or directions
         of  the foreign purchaser;  and

     •   Pesticides being transferred for use by a Federal or State agency
        under  tbe  provisions of :a. Section 18 .emergency exemption.
FIFRA Compliance/Enforcement              1-50           Guidance Manual 1983

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Chapter One	Registration of Pesticides
Registration Procedures	


Types of Registration

The following is a brief description  and  summary of  the types of registra-
tion and the general requirements  for  each  type.

Nev Registrations.  The following  must be filed with the Registration
Division:

     *  Application for Pesticide  (EPA Form 8570-1);

     •  Confidential Statement of  Formula (EPA Form  8570-4);

     «  Five copies of the proposed labeling;

     •  Supporting data concerning product  efficacy, general  and environ-
        mental chemistry, and hazard,  as  required by 40 C.F.R.  §162.8;

     •  Offer-To-Pay Statement;

     •  Certification Statement;

     •  Statement proposing a classification of general or  restricted use
        for the product;

     •  Supportive data; and

     •  Any other information required.

NOTE:  Filing an application does  not  constitute registration.   Once  a
       company files an initial application, it is assigned a permanent
       registrant number.  This number, followed by  a hyphen  and letters  is
       the file symbol.  When and  if  the  product is  accepted  for registra-
       tion, the file symbol is converted to the product registration
       number.

       Ex.  Before Acceptance             After Acceptance

            File Symbol                   EPA  Registration  Number
              339-R                              339-1

Amended Registrations.  An application for  amended registration  must  be
submitted when changes are proposed in the  labeling  (such as  the addition
of new uses, change in product name, or request  for  additional brand  names)
or when minor changes are proposed in  the formulation  of  the  pesticide.
The following must be submitted:

     •  Application for Amended Pesticide Product Registration (EPA Form
        8570-11);
FIFEA Compliance/Enforcement             1-51          Guidance Manual  1983

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 Chapter  One	        	Registration of Pesticides
      •   Two draft copies of the proposed changes to the previously approved
         labeling with supporting data;  and

      •   Five  copies  of the final printed label in accordance with 40 C.F.R.
         §162.10, Labeling Requirements.  Final printed labeling need not be
         submitted until after draft copies are approved by EPA.

When  a minor  change  in the product's chemistry is desired, the Confidential
Statement  of  Formula (EPA Form 8570-4)  should also be submitted.  If the
addition of a new use requires data, then two copies of this data should
also  be  submitted.
Distribution Under Amended Labeling

After  the  effective date of a change in labeling or formula (the acceptance
date),  the product may still be  marketed using the previously accepted
label  during the  five-year registration period,  unless  the Registration
.Division indicates- otherwise.

Supplemental Registrations (Private Labels).   A basic registrant's product
can be  supplementally  registered for a  distributor,  thus  allowing the
distributor  to market  the  product under his or her own  brand name without a
separate registration.

Certain conditions are  applicable for supplemental registration:

     •  The  distributor's  product must  have the  same composition as the
        basic registrant's product;

     •  The  distributor's  product must  .be manufactured  and packaged by the
        same person who manufactures and packages  the registered basic
        product;

     •  The  product labeling for the distributor must bear the same claims
        as  the basic product provided;  however,  specific  claims may be
        deleted if by  so doing no other changes  are  necessary;

     •  The  product must remain  in the  manufacturer's unbroken container;

    '=•• Ihe .iabel  must  iear..±he  2PA TegistTatiOTi-number of the tasic regis-
        tered product followed by a hyphen and the distributor's company
        number; and

     •  The  distributor's  product must  bear the  name and  address of the
        distributor, qualified by such  terms as  "Packed for...," "Distri-
        buted by...," or "Sold by...."
FIFRA CoBpliance/Enforceaent1-52           Guidance  Manual  1983

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 Chapter  One	Registration of Pesticides
The  following  should be  submitted  by  the  registrant:

     •  Application for  Supplemental  Registration of  Distributor (EPA Form
        8570-5), which includes  proof of  concurrence  by the distributor;
        and

     •  Distributor's company number  for  each  proposed  distributor.

Renewal Registrations.*  Registration is  effective for  a period of five
years from the date of registration.   At  the end  of the registration
period, a notice of intent  to cancel  will  be sent to  the registrant at the
latest address known to  the Registration  Division.   If  a registrant wishes
to continue  the registration in  effect after the  expiration of the five-
year registration period, a request for renewal registration must be made
within 30 days of receipt of a notice of  intent to  cancel.   If a continu-
ance is not  requested, cancellation of registration will become effective
at the end of  the 30-day period  following  receipt of  the notice.

Applications for renewal are subject  to certain labeling and data require-
ments.  If the product or its labeling fails to comply  with current
requirements,  the registrant will  be  afforded  an  opportunity to make the
necessary corrections.   Following  receipt  of a notice of intent to continue
registration,  the Registration Division may request specific data from the
registrant.

Re-registration.  FIFRA  Section  3(g) ,  as  amended  in 1978,  directs EPA to
re-register  all currently registered  products  as  expeditiously as
possible.  Central to the re-registration  program is  a  document called a
Registration Standard.   Each standard summarizes  all  the data available to
the Agency on  a particular  active  ingredient and  its  current uses, and sets
forth the Agency's position and  requirements for  a  company to retain full
registration.

Once a standard is published, the  Agency will  solicit the  appropriate
registrants  to re-register  their products.  Those registrants who wish to
continue to  sell or distribute their  product in commerce must then meet the
conditions and requirements of the standard.   Although  these requirements
may vary from one active ingredient to another, in  general  they include:

     •  Submission of needed scientific data that the Agency does not have;

     •  Compliance with standards  of  toxicity, composition,  labeling, and
        packaging; and

     •  Satisfaction of the data compensation  provisions.
* The five-year renewal program is currently inoperative.
FIFSA Compliance/Enforcement             1-53          Guidance Mgp"al  1983

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 Chapter  One	Registration of Pesticides
Conditional Registration.  FIFRA Section 3(c)(7)  authorizes the
Administrator  to conditionally register  a pesticide product even though
certain  required data may not have  been  submitted or evaluated by EPA.   A
conditional registration is a registration for which the submission (or
Agency review) has been deferred to a future  date.
Labeling  Requirements	^^^


The registration  program is designed  to  ensure  that  pesticide  products will
be safe and  effective  when used  in  accordance with  statements  listed  on  the
label.  FIFRA requires every pesticide product  to bear  a  label containing
the following:

     •  Name,  brand, or trademark under  which the product is sold;

     •  Name and  address  of producer, registrant, or person for whom
        produced;

     •  Net  contents statement;

     •  Product registration number (EPA Reg. No.);

     •  Producing establishment  number (EPA Est. No.) (This number may be
        placed on the  immediate  container instead of the  label.);

     •  Ingredient  statement;

     •  Warning or  precautionary statement;

   . *»  Directions  for  use;  and

     •  Use  classification.
FIFRA Compliance/Enforcement             1-54          Guidance Manual 1983

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Chapter  One
4b     Establishment Registration
 Establishment registration  is accomplished through application by a respon-
 sible company official  to the Pesticides Group in the  appropriate Regional
 Office of EPA.  Registration is a formal procedure,  and  the firm should
 make written application to the EPA Regional Office  having jurisdiction for
 the State in which the  establishment is located.   Foreign companies who
 wish to register their  establishment with EPA should submit an application
 form to the Headquarters PTSOiS in Washington, B.C.  The Regional Office or
 Headquarters will assign an establishment number.

 Each establishment will be  assigned only one EPA establishment number.  (In
 rare instances, an exception may be made when two separate corporate
 entities use the same facilities.)  All pesticide products and active
 ingredients released for shipment in interstate commerce or released for
 export from or import into  the United States must bear the establishment
 number.  The establishment  number must appear on the label or immediate
 container of all pesticide  products.
Authority
Section 7 of FIFRA and 40 C.F.R. Part 167 require  that  establishments be
registered with EPA before producing any pesticide  product or active ingre-
dient.*

Section 25(c)(4) of FIFRA gives the Administrator  authority "to specify
those classes of devices which shall be subject  to  any  provision of para-
graph 2(q)(l) [misbranding] or section 7 [establishment registration]...."
   Proposed rules  are under development for incorporating the term "active
   ingredient" under FIFRA §7 requirements.
FIFRA Conpliance/Enforceiaent             1-55          Guidance Manual  1983

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 Chapter One	Establishment Registration
 Objectives	   	


 The  objectives of the establishment registration are to:

      •   Identify the production site at which a pesticide, device, or
         active ingredient was produced;

      •   Provide for more efficient  production monitoring;

      •   Identify the producer in the event  that enforcement action is
         required;

      •   Identify the production site in the event  it is necessary to  recall
         or stop sale of  pesticides  or pesticidal devices  due to adverse
         effects to  humans or  the environment through accident,  willful
         misuse, mishandling,  or other adverse actions; and

      •   Determine total  quantities  and types of pesticidal chemicals  or
         devices introduced into the environment.
Applicability  of  Registration  Requirements	


All establishments where  pesticides, devices,  or  active  ingredients  are
produced must  be  registered  except for  those pesticides  or  devices not sub-
ject to provisions of  the Act  or those  active  ingredients that  are used  to
produce pesticides not  subject to provisions of the  Act.  The  term
"produce" has  been defined in  the regulations  as  meaning  "to manufacture,
prepare, propagate, compound,  or process any pesticide...including any
pesticide produced for use pursuant to  Sections 3, 5,  17, 18,  or  24,  or  any
active ingredient used  in producing a pesticide or device." The  term also
means to repackage or  otherwise change  the container of  any pesticide,
active ingredient, or  device.   The following establishments are in this
category and must be registered:

     •  Producers who  use active ingredients in making a  pesticide;

     •  Producers of technical material;

     •  Formulators;

     •  Repackagers;

     •  Custom blenders;

     •  Producers of pesticide products for export;
FLFRA Conpliance/Enforceaent1-56Guidance Manual 1983

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Chapter One	Establishment Registration



     e  Foreign producers who  export  products  to  the United States; and

     e  Producers of pesticides  under  experimental use permits.

In addition, establishments  that  produce  pesticides for other companies
under a contract must also be  registered.   The  establishment number of the
actual producer must appear  on all products.



Registration Procedures	


Initial Registration

EPA Form 3540-8, Application for  Registration  of  Pesticide-Producing
Establishments, must be  completed and  submitted to the appropriate Regional
Office or to Headquarters.

The Pesticides Group in  each Regional  Office or the Headquarters PTSCMS
will review the applications.  Applicants  will  be contacted by these
offices when errors or omissions  are apparent.   Pesticide inspectors will
be called upon, as necessary,  to  verify application information.


Changes to Existing Registration

Changes in company headquarters,  ownership, or  address (as identified in
Item 2 of EPA Form 3540-8) must be reported within 30 days to the EPA
Regional Office having jurisdiction over  the State in which the company
headquarters is located.


Cancellation "or Revocation of  Registration

If a registered establishment  no  longer produces  pesticides, the Regional
Office should be notified to request cancellation of the registration,
unless the firm intends  to re-enter production  at a later date.

The registration of an establishment may be revoked for one of the
following reasons:

     •  Company request;

     •  Failure of company to  submit required reports;  or

     e  Registration due to  administrative or other error.

An establishment registration may not  be revoked  or terminated for viola-
tions of other requirements  under FIFRA.   Civil or criminal penalties are
applied for other violations and the establishment registration remains  in
effect.
FIF2A Cojapliance/Enforceiaent              1-57           Guidance M?nna1  1983

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 Chapter  One  	         	Establishment Registration
Establishment  Registration Numbers
The  EPA Regional  Office  or PTSCMS will  assign an establishment number to
applicants.   The  numbering system is  based  on the company registrant
number,  the  abbreviation for the  State  in which  the  establishment  is
located,  and a  sequential number  for  each establishment  registered by that
company within  the  State.
Placement  on  Label  or  Container

The establishment number  preceded  by  "EPA Est."  must  appear  on all  pack-
aging and  containers as follows:

                        Example:   EPA Est.   777-KY-3

That number is to be the  one  assigned  to  the  last  establishment  at  which
the product was  produced  or repackaged.   No  combinations  of  product regis-
tration and establishment  numbers  will be  permitted.   The establishment
number may appear anywhere on the  pesticide  container or  on  the  label.   It
must also  appear on the outside container  or  wrapper  of the  package if  it
cannot be  clearly read on  the immediate container.

The establishment number  is to be  used in  addition  to and not  in lieu of
the product registration number.  Both  the  establishment  number  and  the
product registration number  must  appear on  the  product  released  for  ship-
ment.  The establishment number may be  on either  the  label  or  the  immediate
container, while  the product registration number  must appear on  the  label.

Producers may seek approval  of various  techniques or  formats for displaying
the establishment number.  If the company obtains approval  to  include  more
than one establishment number on  a label, the producing establishment  for
the labeled product must be  marked, notched, or otherwise clearly  noted
thereon for identification purposes.  Following are examples of  approved
formats that may  be adopted  for use by  pesticide  producers.

     •  Example 1.  The company (registrant) number is  123, and  there  are
        three registered establishments—two in Indiana (IN) and one in
        Massachusetts  (MA).   The  three  establishment  numbers are printed  in
        full.  Those products produced  at the second  site in Indiana may  be
        identified by a saw-cut,  notch, arrow (as shown), or similar
        indicator.

               EPA Est. 123-IN-l
                        123-IS-2  <
                        123-MA-l
FIFRA Cottpliance/Eaforceraent              1-58          Guidance Manual  1983

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Chapter One                                       Establishment Registration
     e  Example 2.  The company  (registrant)  number is  followed by the
        State abbreviation and the digit(s)  of  the  establishment(s) located
        in that State.  When another  State  is  introduced,  the company
        number need not be repeated.   To  indicate the  actual production
        site, the establishment  digit  may be  identified by a saw-cut,
        notch, arrow (as shown), or similar  indicator.   This example shows
        a product produced at the second  site  in  Indiana.

               EPA Est. 123-IS-l-2<:  MA-1.

     •  Example 3.  The producer is adding  its  own  code number to identify
        the actual production site.   Each of  the  three  establishment
        numbers on the label will be  followed  by  a.  code; a statement
        following the numbers will explain  that the inspector must look on
        the bottom of the container to determine  the actual producing
        establishment..

               EPA Ect. 123-1::-1, 2:  K&.-1

               See last letter on bottom  of
               can for actual establishment.

Other variations must be approved by  Headquarters PTSCMS.   (In no case may
the establishment number be combined with the  product  registration number.)
Establishment Production Reports


Each producer must submit an annual report  of  pesticide  production to
include activities relating to:

     o  Manufacture;                    -    -       -  -  -

     e  Formulation;

     «  Repackaging;

     •  Export and import;

     •  Experimental use;

     •  Special local needs of States; and

     •  Federal and State emergency exemptions.

Producers who manufacture their own products and serve as  distributors  of
other products must report only their own production.  Distributors  and
sellers need not report if they are not producers.   Also,  any person who  is
a producer solely because he or she produces a custom-blended pesticide
need not report.
FIFEA Compliance/EujJorceEisnt              1-59           Guidance  Manual  1983

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 Chapter  One    	            	Establishment Registration
Each establishment must have its own report  and may not be combined in the
case of  one  company having several  establishment locations.   However,  the
company  headquarters may complete the forms.


When To  Report

Reports  from all  registered establishments must be  submitted annually, by
February 1,  to  the Regional Office  having jurisdiction over  the State  in
which the  establishment is located.   The original and  one  copy of  the  form
are  to be  submitted.

When a new establishment is registered, a pesticides report  must be sub-
mitted to  the Regional Office  or to  Headquarters within 30 days after
notification of registration.   A pesticides report  form (EPA Form  3540-16)
will be  furnished to the producer with the assignment  of the establishment.
number.
What To Report

Only those products  actually  produced at  the reporting  establishment  should
be included.  Information  on  products sold or distributed  by,  but  not  pro-
duced at, the reporting  establishment is  not to  be  included  in this report.

Products produced  under  several distributor numbers  are to be  reported as
one product under  the  basic product number and using  the registered product
name.

The Annual Production  Report  Form is used to prepare  the annual report.
Information required for the  report includes:

     •  Establishment  name and address;

     •  Establishment  number;

     •  Listing  of each  pesticide product or device  produced;

     •  Pesticide  registration number;

     •  Product  name;  and

     •  Chemical formulation, if the product or  device:

        -  Is not  registered with EPA or  the State,
        -  Does  not  have registration applied for,
        -  Is produced under  an experimental use permit, or
        -  Is an unregistered technical material shipped under  a Section 3b
           exemption.
FIFRA Conpliance/Enforcement             1-60          Guidance Manual  1983

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Chapter One	Establishment Registration
Confident ialit"

Section 7(d) of FIF2A provides  that  any  information  submitted by industry
to EPA pursuant to an establishment  registration  application will be con-
sidered confidential and subject  to  the  provisions of Section 10
(Protection of Trade Secrets and  Other Infomatior.)  of the Act.

Section 12(a)(2)(D) of FIFRA provides that  it  is  unlawful  for any person
"to use for his own advantage or  to  reveal,  other than to  the Administra-
tor, or officials or employees  of  the Environmental  Protection Agency or
other Federal executive agencies,  or to  the  courts,  or to  physicians,
pharmacists, and other qualified  persons, needing such information for the
performance of their duties, in accordance with such directions as the
Administrator may prescribe, any  information acquired by authority of this
Act which is confidential under this Act."   In addition, Section 10(f)
provides that any past or present  officer or employee of the United States
who willfully discloses confidential information  subject to Section 10(b)
to any person not entitled  to receive such information shall be fined not
more than $10,000, or imprisoned  for not more  than one year, or both.  (See
Chapter Eleven for specific information  concerning confidentiality
procedures.)
FIFRA CoEipliance/Eiiforcecient             1-61          Guidance Manual  1983

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Chapter  One   	^	Establishment Eeglstration
FIfRA Compliance/Enforcement1-62Guidance Manual 1983

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Chapter  One
         p
         I
•ticido  Uiso^.
Authority
Under Section 19 of FIFRA, the Agency has the authority to issue procedures
and regulations for the disposal and storage of excess  pesticides,  pesti-
cide containers, and pesticide-related wastes.  Because of certain  informa-
tion gaps and a nationwide shortage of safe disposal facilities, the Agency
has issued guidelines and recommended procedures for the disposal and
storage of pesticides as the first step in fulfilling its mandate to regu-
late the disposal of pesticides (39 Fed. Reg. 15236, 40 C.F.R.  Part 165).
As a second step, the Agency intends to promulgate a set of regulations
that prohibit the "worst acts" of pesticide disposal and storage and, even-
tually, to proiuulgate comprehensive regulations for the disposal and
storage of pesticides.
Enforcement Actions and Disposal Practices
Section 19 Regulations and Recommended Procedures
The procedures for disposal and storage  of  excess  pesticides,  pesticide
containers, and pesticide-related wastes,  promulgated  pursuant to Section
19 (40 C.F.R. §165.7 et seq.),  are merely  recommended  procedures  and  do not
carry the force of law.  While  all persons  or  parties  should be encouraged
to follow the Section 19 guidelines,  no  enforcement  action will be taken
against those who do not adhere to the guidelines.

Nonetheless, it is unlawful to  dispose of  pesticides in  a manner  inconsis-
tent with the label directions  for disposal [Section 12(a)(2)(G)]  unless
the person is following these  Section 19 procedures.

However, pursuant to Executive  Order  11752  (38 Fed.  Reg.  34793),  compliance
with the Section 19 recommended procedures  for the disposal and storage of
pesticides is mandatory for all Federal  agencies.
FIFEA Cottpliance/Eiiforcer^Et              1-63           Guidance Manual  1983

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Chapter  One	                          Pesticide Disposal
Transportation  of  Unregistered  Pesticides  for  the  Purpose of  Disposal

Although  the  shipment  of  an  unregistered pesticide is  an unlawful  act  pur-
suant  to  Section  12(a)(l)(A), the Agency has interpreted Section 19  as
authorizing the Eovement:  of  such pesticides for  the  specific  purposes  of
disposal  or storage  (38 Fed. Reg. 15237).  Thus  civil  or criminal  penalties
will not  be imposed  upon  persons shipping  unregistered pesticides  to dis-
posal  sites.

In the event  that  there is some question as to whether unregistered
pesticides are  actually being shipped for  disposal,  regional  enforcement
officers  should make inquiries  to confirm  that such  shipments are  for  the
purpose of disposal.   If  satisfactory evidence is  not  available  to show
that the  unregistered  pesticides were actually being shipped  for disposal
or if  routine investigation  does not corroborate the owner's  claim of  ship-
ment for  disposal, a civil complaint or a  civil  penalty warning  citation
may be issued as  appropriate.   The person  cited  may  then offer evidence in
a settlement  conference or plead as an affirmative defense in a  civil
penalty hearing that the  unregistered pesticides were  actually being
shipped for disposal.  The regional enforcement  personnel should encourage
those  persons interested  in  shipping unregistered  pesticides  to  disposal
sites  to  notify the  Regional Office in advance of  such shipments.
FIFRA CojapHance/Enforceaent             1-64          Guidance Manual  1983

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  C}_ _ ^ i ^ ,..
  i I C. K' L C-: i
         Fv n^'innpntpi!  1  !^^  pprrnit
         I	/\ i.J >_': i i I  i O i  i L C". i  W «^,' v^/  i  t? I  I I i i L
O
Authority
Section 5 of FIFRA and 40 C.F.R.  Part  172  provide  the  Administrator with
the authority to issue an experimental  use permit  in order  for  an  applicant
to accumulate information necessary  to  register  a  pesticide  under  Section 3
or to secure information for  a new use  of  a registered  pesticide.

The Administrator may revoke  any  experimental  use  permit:   (1)  if  it  is
found that the terms or conditions are  being violated;  (2)  if its  terms or
conditions are inadequate to  avoid unreasonable  adverse effects to the
environment; (3) if new evidence  is  obtained which demonstrates that  the
tolerance will be inadequate  to protect the public health;  or (4)  for
failure to meet"any provisions of 40 C.F.R.  Part 172.
Scope
The regulatory provisions  of  FIFRA for  experimental use  permits do not
apply to tests to  determine  the  purpose,  toxicity, or  properties of a
pesticide,  where the  tester  does  not  expect  to  receive any benefits from
the use of  the pesticide.
Permit Application Procedures	


An application (EPA Form 8570-17)  for  an  experimental use permit must be
submitted in triplicate  to  the  Registration Division of the Office of
Pesticide Programs.   The contents  must  include:

     e  Names and  addresses  of  applicants, participants, and cooperators;

     «  Registration number  of  product, if registered;

     •  Proposed method  of  storage and  disposal;



FIFEA Compliance/Enforcement1-65Guidance Manual 1983

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Chapter  One	Experimental Use Peraits



     e   Proposed  objective and  purpose  of  testing;

     e   Factors relating to testing  program;  and

     •   Tolerance data.

For an unregistered  pesticide product,  the  application must  also include:

     •   Confidential statement  of  composition;

     •   Chemical  and physical properties of active  ingredients;

     •   Data  of the  rate of decline  of  residues on  treated  crop or environ-
         mental site  or other data  regarding entry into treated areas;  and

     •   Results of toxicity tests.

The permit will be issued upon  the determination by the Administrator  that
the statutory and regulatory provisions of  Section  5 have been met.  The
permit .will specify  the  conditions,  duration, and recordkeeping require-
ments .



Labeling Requirements	


All pesticides shipped or used  under an experimental use permit must be
labeled with  the  following (40  C.F.R. §172.6):

     •   The statement "For Experimental Use Only";

     •   Permit number;

     •   The statement "Not for  sale  to any  person other than  a partici-
         pant or cooperator of the  EPA-approved experimental use program";

     •   Name, brand, or  trademark;

     •  .Name and  address  of  the permittee,  producer,  or registrant;

     •   Net contents;

     •   Ingredient statement;

     •  Warning or caution statement;

     <•  Limitations .on entry into  treated areas;

     •   Establishment registration number,  if appropriate; and

     •   Directions for use.
FURA Compliance/Rnforceiaent              1-66          Guidance Manual  1983

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Chapter
4e    Emergency  Exemptions  for  Federal
        anc! State Agencies
Under Section 18 of FIFRA the Administrator has  the authority to exempt
Federal and Sta.te agencies from the requirements of the Act under the
following emergency conditions:

     e  A pest outbreak has or is about to occur and no pesticide regis-
        tered for the particular use, or alternative method of control, is
        available;

     c  Significant economic or health problems would occur without  the
        use of the pesticide; or

     e  There is insufficient time to register a pesticide before the dis-
        covery or prediction of a pest outbreak.
Types of Exemptions	


Specific "Exemption

A specific exemption may ba granted  to control  the outbreak of a pest in
the United States and is valid only  for the specific situation involved.
Exemption conditions may include:

     « Limitation on quantity of  pesticide used;

     • Conditions under which it  may be applied;

     • Persons  who may apply the  pesticide;

     • Monitoring activities; and

     e Duration of exemption (never longer than one year).
FIFSA CoT-Tjliance/Enforce-szit            1-67         Guidance Manual 1983

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 Chapter One	Emergency Eseaptioas for Federal and State Agencies
 Quarantine/Public Health Exemption

 A quarantine or public health exemption may be granted to prevent the
 introduction or spread of a foreign pest .into or throughout the United
 States.   Exemption conditions include:

      •   Duration of exemption (never longer than one year, although  the
         Administrator may renew the exemption); and

      •   No pesticide may be used that has been suspended by the
         Administrator.
 Crisis  Exemption

 Crisis  exemptions  are granted to any Federal or State agency in situations
 involving  the  unpredictable outbreak of pests in the United States where
 the responsible  official in authority determines:

     •   There  is no  readily available pesticide registered for the parti-
         cular  use; and

     •   The  time element is too critical to request a specific exemption.
Procedures  To  Be  Followed	


Specific  Exemption

Upon approval  of  a  specific  exemption,  the  Federal or.State agency must:

     •  Immediately inform the  Administrator  in writing of the time and
        place  of  pesticide application;

     •  Inform the  Administrator  of  the  location,  quantity, and extent of
        use of the  pesticide within  10  days of  final application or use;

     •  Initiate  monitoring  activities  specified by the exemption and
        report .any...adverse effects .to -the ..Agency;  and

     •  Provide the Administrator with  a summary report on the emergency
        action taken and  the outcome of  such  action within one year of the
     ~~  granting  of the exemption.
FUEA ConpHance/Enforceraent Manual       1-68           Guidance Manual 1983

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 Chapter  tee	Esvsrccenc;?  Sxe-yptloii;-: for ^ecerzJL and State Agencie."-;
Quarantine/Public  health  Exemption

The  Federal  or  Stats  agency  using or  applying pesticides under this exemp-
tion mus t:

     c  Maintain records  of  all  treatments including:

        -  Application  site,
        -  Pesticide  used,
        -  Rate of application,  and
        -  Quantity used; and

     «   Submit  to  the Administrator and  the Hearing Clerk of the Agency,
        one  month  after the  expiration of  the exemption, a report listing:

        -  Number  of  treatments,
        -  Pesticides used for each type of treatment, and
           Steps taken  to comply with registration requirements of the Act.


Crisis Exemption

When a Federal  or  State agency determines  that it will avail itself of a
crisis exemption,  the head of the Federal  agency or the Governor of the
State or their  designees must notify  the Administrator by telegram within
36 hours of  this determination.

Within 10 days  of  the application for use  of  the pesticide,  they must file
with the Administrator  the following  certified information:

     o  The  nature and  scope of  the emergency, including the pest involved;

     c  That no pesticide registered  for the  particular use  was readily
        available, and  the basis  for  such  determination;

     o  That the time element was  too critical to request a  specific or
        quarantine/public health  exemption;

     o  The  location, quantity, method of  application, duration of applica-
        tion, and qualifications  of personnel involved in the application;

     •  The  steps being taken to  reduce  adverse  effects; and

     •  Any  other information requested  by the Administrator.
FIFSA Compliance/Enforcement iianusl       1-69           Guidance Manual  1983

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 Chapter One	Eaergency gserrpticus  for  Federal, and State Agencies
 Withdrawal of uceraDtion
 The  Administrator will withdraw an exemption upon  determination  that:

      •   An agency is not complying with the requirements  of  the  exemption;
         or

      •   Such action is necessary to protect humans or  the  environment.
FIFSA Coinpliance/Enforcement              1-70          Guidance Mgji"*1 1983

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  1--. /— •»—. * /"• -"• i'*~"\ -•-. -v
  I I d p I o- i  L/' i i c:
-
        O f '"'> "!" /"N   D <~\ r~*' i o -•• " s~^ ^ : /*^ ^   /~\ -f  D /^\ o 4- 1 /~* i /H /~> i
        olaic-'   ndCiiSii airo: i   ui  r6SIiG!Q6.
Under Section 24(c) of FIFIL's, a  State  is  authorized  to  register a new end
use product for any use, or additional use  of  a  federally registered pesti-
cide .,
Conditions for Section 2Iiaxica/:i-afcrcaua-at             1-71          Guidance Kanual  1983

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 Chapter One                                State Se-^rlstratioa of Pesticides
      e   Any use of a federally registered product for which registration of
         other uses of the product was denied, disapproved, cancelled, or
         suspended; and

      •   Any use of a federally registered product for which registration of
         some or all uses has been voluntarily cancelled by the registrant.

 State-issued registrations for new products are based on the following pro-
 duct  criteria:

      •   A product identical in composition to a federally registered pro-
         duct but different in packaging or identity of the formulation;

      •   A product that contains the same active and inert ingredients as a
         federally registered product, but in different percentages; and

      e   A product containing a new combination of active or active and
         inert ingredients if each active or inert ingredient is contained
         in a federally registered pesticide.
Registration  Disapproval/Suspension	


General Disapproval

State registrations  that  do  not  have  a  composition .and use pattern which is
similar to  federally registered  pesticide products may be disapproved by
the Administrator  if there are reasonable grounds.


Special Disapproval

The Administrator  may disapprove any  State registration,  including a regis-
tration for a  similar product if it is  determined that the use of the pro-
duct:

     •  Would  constitute  an  imminent  hazard;  or

     •  May result in a residue  on food or feed exceeding or not covered by
        a tolerance, exemption,  or other clearance under  the Federal Food,
        Drug,  and  Cosmetic Act.
Suspension

The Administrator may  suspend  all or any  part  of  a  State's  authority  to
register pesticides under  Section 24(c) if  the State:

     •  Is not  capable  of  exercising adequate  pesticide  controls;  or

     e  Has failed to  exercise adequate pesticide controls.
FIFEA Compliance/Eafcrceiiani1-72           Guidance Manual  1983

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Chaoier One
               O Q ;••" \ /
               o ci;  y
ACT — When used in this manual, "the Act" means the Federal Insecticide,
   Fungicide, and Rodenricide Act, as amended (FIFRA)-

ADMINISTRATIVE LAW JUDGE — An Administrative Law Judge appointed pursuant
   to 5 U.S.C. §3105 (see also 5 C.F.R. Part 930, as amended by  37 Fed.
   Reg. 1678S).

ADMINISTRATOR — The Administrator of the Environmental Protection Agency.

ADULTERATED — A pesticide is adulterated if:

   — Its strength or purity falls below the professed standard  of quality
      as expressed on its labeling under which it is sold;

   — Any substance has been substituted wholly or in part for the pesti-
      cide; or

   — Any valuable constituent of the pesticide has been wholly  or in part
      abstracted.

AFFIDAVIT — A written statement made on oath before a notary public or
   other person authorized to administer oaths.

AGEKCY — The United States Environmental Protection Agency (SPA).

BATCH — A quantity of a pesticide product made in one operation or lot or
   if made in a continuous or semi-continuous process or cycle,  the quan-
   tity produced during an interval of time to be determined 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 C.F.R. §169.2 and all records in lieu thereof.

CERTIFIED APPLICATOR — Any individual who is certified under Section I* as
   authorized to use or supervise the use of any pesticide that  is clas-
   sified for restricted use.
FIFRA Compliance/Enforcement             1-73          Guidance Manual 1983

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 Chapter  One                                                         Glossary
CIVIL  ADMINISTRATIVE COMPLAINT — A written communication alleging one or
   more  violations  of specific provisions  of  the  Act  or  regulations
   promulgated  thereunder (40 C.F.R.  §22.03).   Each complaint  shall
   include:   (1)  reference  to the provisions  of the Act  alleged to have
   been  violated;  (2) a concise factual  statement of  the violation; (3) the
   amount  of  the  proposed penalty;  (4) a statement of the appropriateness
   of  the  penalty;  (5)  notice of the  respondent's rights to  an adjudicator}'
   hearing; and (6)  a statement reciting the  section(s)  of the Act
   authorizing  the  issuance of the  complaint  (40  C.F.R.  §22.14).

COMMERCIAL APPLICATOR — A certified  applicator (whether or  not he or she
   is  a  private applicator  with respect  to  some uses) who uses or super-
   vises the  use  of  any pesticide that is classified  for restricted use for
   any purpose  or on any property other  than  as provided by  the definition
   of  "private  applicator."

COMPLAINANT —  Any  person authorized  to  issue  a complaint on behalf of the
   Agency  to  persons alleged to be  in violation of the Act (40 C.F.R.
   §22.03).

CONSENT  AGREEMENT — Any written document containing  stipulations of fact;
   conclusions  regarding material issues of law,  Fact, or discretion; and a
   specified  proposed penalty acceptable to both  complainant and  respondent
   that  results from any settlement conference  (40 C.F.R. §22.18).

COOPERATOR — Any person who  grants permission  to a permittee  or  a  permit-
   tee's designated  participant for the  use of  an experimental use  pesti-
   cide  at an application site owned  or  controlled by the cooperator.

CUSTOM BLENDED  PESTICIDE — A pesticide  that meets the following
   conditions:

   —  The  blend contains only registered pesticides,  fertilizers, and
       inert ingredients;

   —  Each pesticide used in  the  blend bears end-use  labeling  directions
       providing for  use  of  the product in such  a  blend,  or the blend is
       recommended in writing  by an appropriate  State  or  Federal agency
       official;

   —  The  blend is produced  to  the order of the user;

   —  The  blend is not held in the inventory; and

   —  The  blend is delivered  to  the user with a copy  of  the  end-use
       labeling  of the pesticide(s) used  in the  blend  and a statement
       specifying the composition of the mixture.
FIFBA Compliance/Enforcement              1-74          Guidance Manual 1983

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DEFAULT C?,DIIl — An order issued pursuant  to  40  C.F.R.  §22.17 disposing cf
   a natter cf cor "re •-•arsy b-;f.'--e~n respondent  and  the  Agency upon (1) the
   failure of respondent to file a timely  answer to  the complaint; (2) the
   fs.ilu.re of one cf the. parries to comply vith  a  prehearir.g or hearing
   order of the Presiding Officer, or  (5)  the.  failure  of one cf the parties
   to appear at a conference or hearing without  good  cause being shown.

DEGRADATION PRODUCT — A substance resulting  from  the  transformation of a
   pesticide by physical', chemical, or electromagnetic means.

DEVICE — Any instrument or contrivance  (other than  a  firearm) that is
   intended for trapping, destroying,  repelling, or  mitigating any pest or
   other form cf plant or animal life  (other  than  humans and other than
   bacteria, viruses, or other microorganisms  on or  in living humans or
   other living animals); but not including equipment  used for the
   application of pscticicas when sold separately  therefrom.

DISTRICT COURT — A United States district court,  the  District Court of
   Guam, the District Court cf the Virgin  Islands, and the highest court of
   American Samoa.

DRIFT — Movement of a pesticide through the  air (during or immediately
   after application or use) to a site other  than  the  intended site of
   application or use.

EFFICACY — The capacity of a pesticide product  v;hen used according to
   label directions to control, kill,  or induce  the  desired action in the
   target pest.

ENVIRONMENT — Includes water, air, land,  and  all  plants, humans and other
   animals living therein, and the interrelationships  that exist among
   these.

ESTABLISHMENT — Any place where a pesticide  or  device is produced cr held
   for distribution or sale.

FINAL ORDER — An order issued by the  Administrator  after an appeal of.an
   initial decision, accelerated decision, decision  to dismiss, or default
   order disposing of a matter in controversy  between  the parties or an
   initial decision under 40 C.F.R. §22.27(c).

GENERAL USE PESTICIDE — A pesticide,  when applied in  accordance with its
   directions for use, warnings and cautions  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,  will not generally cause
   unreasonable adverse effects on the environment.

HEARING — A hearing open to the public provided in  Section 14(a)(3) of the
   Act and conducted pursuant to the provisions  of Chapter 5, Subchapter II
   of Title 5 of the United States Code, and  the rules of practice found at
   40 C.F.R. Part 22.
FIFSA Coiaplifaj.ceyli2fo"c-c-:,ir-t    "          1-75           Guidance Kanual 1983

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 Chaster One                                                        Glossar-
 HEARING CLERIC — The Hearing Clerk, United States Environmental Protection
    Agency, Washirgton, D.C. 20460
                                  .
 IMMINENT HAZARD — A situation that exists when the continued use of a
    pesticide during the tise required for cancellation proceeding would be
    likely to result in unreasonable adverse effects on the environment or
    will involve unreasonable hazard to the survival of a species declared
    endangered by the Secretary of the Interior pursuant to the Endangered
    Species Act of 1973.

 INERT INGREDIENT -- An ingredient that is not active [FIFRA §2(m)]; or, all
    ingredients that are not active ingredients as defined in 40 C.F.R.
    §162.3(c), and includes, but is not limited to, the following types of
    ingredients (except when they have pesticidal efficacy of their own):
    solvents such as water; baits such as sugar, starches, and meat scraps;
    dust carriers such as talc and clay; fillers; wetting and spreading
    agents; propellents in aerosol dispensers; and emulsif iers .

 INITIAL DECISION — -The decision issued by the. Administrative Law Judge
    based -upon the 'record of the hearing out of which the decision arises or
    upon the rendering of an accelerated decision.  The decision is suppor-
    by findings of fact and conclusions regarding all material issues of
    law, fact, or discretion.  This decision will become the final decision
    and order of the Administrator without further proceedings unless the
    decision is appealed or the Administrator orders a review of the case.

 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 person may also be known by such
    designations as Consumer Safety Officer, Pesticide Inspector, Accident
    Investigation Officer, Compliance. Officer, etc.

 JUDICIAL OFFICER — An officer or employee of the Agency designated as a
    judicial officer who shall meet the qualifications and perform functions
    provided for in 40 C.F.R. §22.04.

 LABEL — The written, printed, or graphic matter on or attached to the
    pesticide or device or any of its containers or wrappers.

XABELING — 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 [See Section 2(p)(2)(B) of the Act for exceptions].

 MARKET PLACE — All places other than production sites where pesticides or
    devices are held for distribution or sale.

mSBRANDED — A pesticide is nis"branded if:

    — Its labeling bears any statement, design,  or graphic representation,
       relative thereto or to its ingredients, that is false or misleading.
FIFRA Compliance/E^^orcenent             1-76          Guidance Manual 1983

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 Chapter  Or.:-                                                          Glc sr <-•_-•.
                                        ::cir. _r container  or  wrapping that coe;
                                  .s G-rfared r.r sa_e  under  the narae cr ,
   —  Its  lab.4:1  dees  not  beer -he establishment registration number.

   —  Any  required  information on the label or labeling  is  not  prominently
       and  conspicuously placed.

   —  The  accompanyi^  labeling  does not contain directions for use that
       are  necessary for effecting the purpose for which  the product is
       intended,

   —  The  label  dees  no::  contain a required Darning or caution  statement ,

   —.  The  label  d :e::  r.ct  bear an ingredient statement on that part of the
       immediate  container that is displayed under customary conditions of
       purchase.   The  ingredient  statement mu?t also appear  on any outside
       container  cr  wrapper that  conceals ths statement on the immediate
       container.  (The  product is net r.isbranded if its  size and form c;?.l:e
       such  placement  impracticable ar.d if EPA peraits placement elsevhera
       on the  ix™ediata  container cr outside container or wrapper.)

   —  The  labeli-;^;  doe? net  contain a statement of the use  classification
       under which the product is re^lrtered»

   —  There is ••.o label on the ir;:::ediate cor.tr.iner or concealing wrapper
       bearing:

         fi  The  licuie  and  ^dcre.:c c'? the producer, registrant, or person fci
            whorj produced ;

         s  The  nane, brand,  or  trf-demark under which the pesticide is
         a  The net ve.vrht  er  aeacure of the content ; and

         e  The required  registration number and use classification.

   — The pesticide is  highly  toxic to humans ana the label  does  not  bear:

         e  The skull and  crossbones ;

         «  The word  "poison"  prominently in red on a background  of dis-
            tinctly contrasting  color; and

         o  A statement of  practical treatment (first aid or  otherwise)  in
            case of poisoning  by the pesticide.

MISUSE — Use of registered  pesticide ir; a manner not permitted by its
   labeling [see Section  2(ee) of  the Act for exceptions],
    A ""Csupiianca/Z-iforcev-siit              l-7~7          Guidance Manual  1983

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 Cnauter C-e                                                        Glossa—
 NOTICr, OF JUDGMENT — A written notice of all judgments entered in actions
    instituted under the authority of  the Act and includes civil, criminal,
    and seizure actions.

 PACKAGED, LASHED, A27B RELEASED FOR SnlP^ENT — The term, "packaged,
    labeled,  and released for shipment" defines that point in the producing-
    Earketing 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.

    At  the producer establishment level,  such intent to introduce the pro-
    duct into tne channels cf trade (release for shipment) may be evinced by
    any of the following factors:

    —  The producer's assertions that  what is being sampled is representa-
       tive  of what is actually sold;

    —  The storage  of the product in areas,  such as loading docks,  ware-
       houses, or other areas where finished products are held for shipment
       in the ordinary course cf business;

    —  The custom of the pesticide chemical  industry indicates that
       similarly situated products- are intended for release;  or

    —  The custom of the particular producer indicates that similarly situ-
       ated  products have in the past  been intended for release.

    Although  there  is a strong presumption in the situation in which a
    product  is "intended for release"  that the product has been "released
    for shipment,"  it is within the inspector's discretion to entertain a
    producer's assertion that under the particular circumstances such
    product was  not intended for introduction in.to .commerce.

    At  the distribution and retail establishment levels,  products have been
    "released for shipment" at an earlier  time by the producer establishment
    and,  therefore, are subject to inspection and sampling as finished
    products.

 PARTICIPANT  — Any person acting as a representative of  the  permittee, and
    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.

 PARTY  — Any person, group,  organization, agency, or department that parti-
    cipates in a hearing as complainant, respondent, or intervenor.

 PERMITTEE — Any applicant to whom an experimental use permit has  been
    granted.

TERSO'N — Any individual,  partnership, association, corporation,  or any
    organized group of  persons whether  incorporated or not.
FIFKA  Compliance/anforcement              1-78           Guidance Manual  1983

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   as bsin;;  inj jri cj.-  t:  he-£.'_:?: cr v.':-.-'ix-cnc:£:.i.

PESTICIDE — Any  substance  or  r:i::tur£. of substances  intended  fcr preven-
   ting, destroying,  repelling, or -litigating any pest,  or  any substance or
   mixture of substances  intended, for use as £ plant  regulator,  defoliant; _,
   or dessicant.

PESTICIDE FORMULATION:  —  The substance or mixture cf  substances  comprised
   of all active  ar.d  inert  (if any) ingredients of a  pesticide product.

PESTICIDE P-lOZxCT --  A pesticide offered as a commercial  product,  conplete
   viith c-ctiv-  ?.-.:!  i;..::::.  (:'.:: arij'-) it gradients, in a  container having a
   label , a:;d any labeling.

PETITIONER — Any p-rs;cx:  f..rver~ •;.!;•. affc.cu^d by a notice  of  the


PRESIDING C7riCZ;.l —  Th=  Ad^iriistrativs L?T; Judge designated  by  the Chief
   Adainistr?tive La1,?  Judge  to serve  as the Presiding Officer of an admin-
   istrative hsaring  arising cj.r cf the Act,

PRIVATE APPLICATOR  —  A certified applicator v.-ho uses or  supervises the usn
   of any pesticide classified for restricted use for purposes of  producing
   any agricultural coiracdity  en property cvmad•or rented by  the applicator
   or tb.e applicator's  employer or (if applied without compensation ocher
   than trading of  personal  services  betveen producers or agricultural
   coiunoditie;} on  the  property cf mother person.

FR.ODUCE — To Eanuf actura,  prepare, propagate, compound,  or process any
   pesticide, including any  pesticide produced fcr use pursuant  to Sections
   3, 5, 17, 18,  or 24, or  any active ingredient used in  producing a pesti-
   cide or device.  The terra also neans to repackage  or  otherwise  change
   the container  cf any pesticide, active, ingredient, or  device.  "Produce"
   does not mean  to d.ilute,  nix, or blend a registered end-use pesticide
   for personal use according  to label directions, or as  allowed by Section
   2(ee) of the Act.

PRODUCER — Any person  who  produces any pesticide, device, or active
   ingredient.

PROGRAMMED INSPECTION  —  An  inspection requiring the  selection of  a speci-
   fic program activity that is subject to routine compliance monitoring
   and results  from an  enforcement strategy based upon objective selection
   cri teria.

REGIONAL ADrill'ISTHATCa  —• The  Administrator (or delegate) of  a Regional
   Office  of  the  Agency.
      Cor,:pli<.u.ce/£o.force: irit              1-79          Guidance lianual  1933

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 Charter Cr:e                                                        Glossar
 REGIONAL tZARING CLERK — An individual duly authorized by the Regional
    Administrator tc serve as hearing clerk for a given Region.  Correspon-
    dence i^ay be addressed to the Regional Hearing Clerk, United States
    Environmental Protection Ager.cy (address of Regional Office).

 REGIONAL JUDICIAL. OFFICE?. — Ac officer or employee of the Agency duly
    authorized by the Regional Acninistrator to serve as the Judicial
    Officer for the Region as provided in the Consolidated Rules of
    Practice (CROP).

REGISTRANT — A person who has registered any pesticide pursuant to the
    provisions of FIFRA.

 RESIDUE — The active ingredient(s), metabolite(s) , or degradation pro-
    duct (s) that can be detected in the crops, soil, water, or other
    component of the  envircau:ynt (including husans), following the use of
    the  pesticide.

RESPONDENT — Any person proceeded against in a complaint.

RESTRICTED USE PESTICIDE — A pesticide that when applied in accordance
    with its directions for use, warnings and cautions 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, nay
    generally cause without additional regulatory restrictions, unreasonable
    adverse effects en the er_vironn;.er;.t:.

 SPECIAL LQ.CAL .TEED — A pes_ vroblca (existing or imminent within a State)
    that cannot be effectively controlled because an appropriate EPA-
    registered pesticide product; is not  available.

UNDER .THE .DIRECT SUPERVISION 0? A  CERTIFIED APPLICATOR — Unless otherwise
   prescribed by its Labeling,  a pesticide shall be considered to be
    applied under the direct supervision of a certified applicator if it is
    applied by a competent person acting under the instructions and control
    of a certified applicator who is responsible for the actions of that
    person and who is available  if  and when needed,  even though such certi-
    fied applicator is  not physically present at the time and place the
    pesticide is applied.

ONPROGRAMMED .INSPECTION ("Fox Cause"  Inspection)  — An. inspection .in which
   •prooable violations of the Act  are observed or brought  to the attention
    of the Agency through, for example,  an employee's complaint or a compe-
    titor's tip.

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:

   — Application of a pesticide,  including mixing  and loading and any
      required supervisory action  in  or near the  area;
FIFEA CoiapliaGce/Enforce^erit1-80           Guidance Manual 1983

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    —— i_>cc~cir.i rcti.'^T'i.?.  I*"..' ~ •-s t.-, c~c 5 £  C.T-C ocsc2.cr.c2 containersr  and

    — Di£pos;:.l  act:! or.£ for pesticides a-od pesticide containers.

    Use £:  dsf J-Zi :!  l.^rc. ir.corpcrs.tes  applicetic.n.   However,  the  ccrtificc-
    tior. r?.c:ui:'i--.^r.t  for certain  restricted use  pesticides only  applies vfi
    respect to £7-pIica.tior.« of such  pesticides.  Many aspects cf  use do r.c
    include application (e.g., storage cr transportation), and hence are
    outside the  requirersnt for certification.
FIFIIA  (kiiiplicence/Znforci:..ii:t              1-&1.           Guidance Manual 1983

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                                                                      Glcsscr-
FIFSA Compliance/liif or octant
1-8;
Guidance Manual 1983

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Chapter Two
General Operating  Procedures
Chapter Contents	     	Page
Primary Office Responsibilities                          2-1
Concurrence Procedures                                 2-5
State and Federal Interagency Cooperation                  2-5
Organizational Charts                                 2-9
FIFEA Goopliance/Enforceaent         2-i         Guidance Mamml 1983

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Chapter Two
                                                                    Contents
                                                              Manual 1983

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Chapter  Two
General  Operating Procedures
 Primary Office Responsibilities
 The  basic framework setting forth the responsibilities of each EPA office
 participating in enforcement activities was established by the Adminis-
 trator's memorandum of July 6,  1982, entitled "General Operating Procedures
 for  the Civil Enforcement Program"  (GOP).  (See EPA's General Enforcement
 Policy Compendium*)  This chapter describes the respective roles and rela-
 tionships of the various EPA offices that are involved with FIFRA enforce-
 ment.

 EPA's enforcement program includes  both compliance-oriented and legal-
 oriented activities.  The compliance-oriented activities are primarily the
 responsibility of EPA's program offices, and the legal-oriented activities
 are  principally charged to the  Office of Legal and Enforcement Counsel
 (OLEC), Including the Regional  Counsel.  Because many enforcement activi-
 ties involve several aspects, these activities cannot be defined as
 strictly "compliance" or "legal."   Where both elements are present, the EPA
 attorney must be especially diligent in coordinating the legal aspects with
 the  functions of the other participating offices.  The basic relationship
 between the attorney and the program office is that of attorney-client.

 The  basic enforcement functions are divided among the participating offices
 as follows:
 Regional Administrator


      Program Office

      •  Identifies Instances of noncompllance;

      •  Establishes priorities for handling instances of noncompliance;

      •  Evaluates the technical sufficiency of actions designed to remedy
         violations;
 fJfSA Compliance/Enforcement            2-1            g^^fn^m Manual  1983

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 Chapter Two    	             General Operating Procedures
      •  Identifies for formal action those cases that cannot be resolved
         less formally;

      •  Provides technical support necessary for developing cases and con-
         ducting litigation;

      •  Issues written notices of warning;

      •  Issues stop sale, use, or removal orders;

      •  Cooperates with district courts in -the disposition of condemned
         pesticides or devices;*

      •  Issues routine civil administrative complaints;

      •  Evaluates the appropriateness of civil penalties;* and

      •  Negotiates and prepares consent agreements memorializing settle-
         ments' between the Agency and respondents prior to the alleged vio-
         lator's filing of an answer or falling to file an answer to a com-
         plaint.*


      Regional  Counsel

      •   Acts as attorney for "client"  program offices;

      •   Assists program office in drafting or reviewing notices of warning,
         administrative orders, or administrative complaints;

      •   Ensures consistency of action with OLEC guidance;
   •.--•«•  Attends -negotiations wneuevw outside parties are represented by
        counsel In negotiations;

     •  Serves as lead  attorney for the Agency  in administrative proceed-
        ings originating  In the Region; and

     •  Refers requests for emergency temporary restraining orders  to the
        Department of Justice and the appropriate united States Attorney.*


Headquarters

     Program Of f Ice—PTSCMS

     •  Manages national  program matters;
* Consultation with other offices is required.
FIFRA Gompllance/&iforcement             2-2           ^.-t^^^ Manual  1983

-------
 Chapter  Two	             General Operating Procedures
     •  Establishes national enforcement  compliance priorities;

     •  Provides overall direction  to  and accountability measures for the
        enforcement compliance program;

     •  Provides technical support  (including support for litigation
        activities);

     •  Takes lead role in preparing guidance and policy decisions on
        enforcement compliance Issues;

     •  Consults with the Regions,  on  enforcement actions at the earliest
        possible stage in the case  development process for the following
        actions:

        -  "Non-routine" cases of first Impression or those of national
           significance,
        -  Misuse actions,
        -  Proposed civil penalty settlements involving a monetary reduc-
           tion of greater than 40  percent,
        -  Injunctions,
        -  Seizures,
        -  Recall requests, and
        -  Requests to override State enforcement actions; and

     •  Works with OLEC in preparing joint guidance for areas in which com-
        pliance and legal Issues overlap.
     Registration Division

     •  Determines status of product as a pesticide or  device under FIFRA;

     •  Determines registration status of a pesticide;

     •  Assesses significance of scientific test results;

     •  Provides expert witnesses, as appropriate, at legal  proceedings;
        and

     •  Assists In legal services by:

        -  Providing copies of accepted product labels  for Regional Office
           use,
        -  Providing Registration Division support for  substantive  label
           defect review, and
        -  Interpreting label defects.
FlfRA OaapllaBce/Boforcfflment             2-3

-------
 Chapter Two    	                 General Operating Procedures
      OLEC

      •  Provides legal advice regarding enforcement matters to the Assis-
         tant Administrator of Pesticides and Toxic Substances;

      •  Develops legal and enforcement policies and guidance;

      •  Confers with the Department of Justice on the potential impact of
         enforcement policy on litigation matters;

      •  Cooperates with the Assistant-Administrator of Pesticides and Toxic
         Substances in the development  of enforcement policies involving
         both enforcement compliance and enforcement legal activities; and

      •  Assists and supports the Regional Counsel lead attorneys and
         Department of Justice attorneys by coordinating legal activity and
         contributing case information  to the development process.


      Office  of  General Counsel

      •  Provides legal Interpretation  of applicable statutes and regula-
         tions to support the FIFRA enforcement programs;

      e  Has  lead responsibility, in consultation with OLEC, for defensive
         litigation arising out of enforcement actions (e.g., Federal court
         challenges to EPA'a civil penalty proceedings); and

     «  Represents the Agency in national suspension and cancellation pro-
         ceedings.


         -Jtafogcammnt JawMtigalrinii flenter (HEIC)

HEIC  is  located in Denver, Colorado, and functions as a national technical
resource and investigative unit.  HEIC'a expertise in investigation and
evidence discovery can assist case development and provide litigation sup-
port.  The OLEC establishes HEIC's priorities and its availability.
Regional Administrators and the  Assistant Administrator for- Pesticides and
Toxic Substances are requested to involve HEIC in cases that have preceden-
                                   icmnce, <•»..«•»•i»irfi:».<••'•Hf «*i»ai,in. nature.
      UDmpxiance/flftxorcemenc             2—4            Guidance

-------
 Chapter  Two	             General Operating Procedures
Concurrence  Procedures
Generally, Headquarters has waived  concurrences  in routine civil cases.
(Criminal cases oust be referred  to the  Criminal Enforcement Division; see
Chapter Nine.)  However, consultation is required in the following
instances:

     •  Requests  to override  State  enforcement actions;

     •  Requests  for all misuse actions;

     •  Requests  for reduction of civil  penalties greater than 40 percent;
        and

     •  Requests  for recalls, seizures,  and  Injunctions.

The consultation  procedures relating to  each of  the above actions are dis-
cussed in the section of the manual pertaining to the individual subject
matter.
State and Federal Interagency Cooperation


FTFRA charges EPA with the responsibility of  protecting public health and
the environment from the risks associated with  exposure to pesticides.  In
order to fulfill this responsibility,  EPA seeks cooperation with appro-
priate State and Federal agencies.


State Cooperation

Cooperative Enforcement Agreements.  FIFRA  Section 23,  authorizes EPA to
enter into cooperative enforcement agreements with the  States (including
Indian tribes).  Under these agreements, each State conducts compliance
monitoring and enforcement activities  under State  and Federal pesticide
control laws.  These activities Include pesticide  producer establishment
Inspections; marketplace surveillance; pesticide use observations; pesti-
cide misuse investigations; experimental use permit Inspections; and certi-
fied applicator and restricted use pesticide dealer record inspections.

     •  Compliance Monitoring Activities.   Older the cooperative .enforce-
        ment agreements, State personnel are responsible for conducting in-
        spections under both FIFRA and the  State's pesticide lavs.  Daring
        all Inspections and sample collections  performed under FIFRA, the
        State Inspectors use the standard Federal  forms and procedures out-
        lined in the EPA Pesticides Inspection  Manual.   However, during all
        Inspections and sample collections  performed under authority of
        State law, State personnel must use State  forms and follow State
        procedures, including those related to  chain of custody.
FJLTJIA 6Mpliance/&iforcementIFF"	^^^^  MMM!  iiftjf

-------
 Chapter Two 	                General Operating Procedures
     •   Enforcement Activities.   Under the cooperative enforcement agree-
         ments, the State reviews the quality and sufficiency of evidence
         gathered in the course of all investigative activities.  If evi-
         dence  reveals a violation of only the State's pesticide laws, the
         State  would pursue the appropriate remedy provided by State law.
         Where  evidence reveals a possible violation of only Federal law,
         the  State would forward  the information to the EPA Regional Office
         and  prepare testimony and witnesses as necessary.

         If evidence reveals a violation of both State and Federal law, the
         State  may bring appropriate enforcement action under State law or
         refer  the case to EPA for action under FIFRA.  In the event that a
         case is  referred to EPA  for action, the Agency case preparation
         officer  should review the case file to ensure that the State
         inspection procedures adhere to basic constitutional guarantees.
         If the State evidence gathered by State inspectors is obtained
         legally  and is within the scope of admissible evidence, EPA should
         proceed  with the case.

Primacy.  FIFRA  Section 26 provides that a State shall have primary
enforcement  rmsponsibility for -pesticide use violations (primacy) if EPA
determines that  the State has adopted adequate pesticide use laws and has
adequate procedures for implementing these laws.  In addition, Section 26
allows a State to obtain primacy if the State  has entered into a coopera-
tive enforcement agreement with  EPA or has an  approved Section 4 certifica-
tion plan that meets  the requirements for adequate laws and procedures.

Under the Final  Interpretive Rule governing FIFRA Sections 26 and 27 (40
C.F.R. Part  173),  EPA and each State will annually define significant cases
to be tracked  by EPA after referral to  the State.

     e  Compliance Monitoring Activities.   After EPA formally refers a
                    -'case to a State,  the Agency mill contact the State to
        1-earn the results of the inspection and the  State *s  proposed
        enforcement response to the violation.  The  Region should determine
        whether the State has conducted an adequate  investigation.   An
        investigation should be considered adequate  If  the State has (1)
        followed proper sampling and other evidence  gathering techniques;
        (2) responded expedltiouely to the referral; and  (3)  documented all
        inculpatory or exculpatory events or Information.  If the Region
        cannot negotiate an adequate Inspection *l£h±he State, tite Region
                   Its «sa JjjumsMgaf 1iw mfter :«otlce rto *fae  State,  that
        notice should summarize the facts relating to the State Investiga-
        tion, discuss the reasons for EPA's determination that the action
        is inadequate, and state that the EPA mill Initiate its own inves-
        tigation.
     •  Enforcement Activities.  Under primacy, * State has 30 days
                   .        w          .  The teglon-may extend this period
        if required by the procedural characteristics of the State's
        regulatory structure.
      Compliance/Enforcement             2-6           Cnldf"^ manual 1983

-------
Chapter Two	_	General Operating Procedures
        If, after consultation with  the  State,  the  Region determines that
        the State's Intended enforcement response to  the violation is
        inappropriate, EPA may bring Its own  action after notice to the
        State (see 40 C.F.R. Part  173, Section  5 B  for criteria).  That
        notice should summarize  the  facts relating  to the State's enforce-
        ment response, discuss the reasons  for  EPA's  determination that the
        enforcement action is inadequate, and state that EPA will initiate
        its own enforcement action.  However, regional attorneys should not
        initiate an enforcement  action sooner than  30 days after the matter
        was referred to the State.   If a State  determines that the most
        appropriate enforcement  action is not available under State lav, it
        may refer the case In writing to EPA  for enforcement under FIFRA.


Federal Interagency Cooperation

United States Department of Justice  (DOJ).  EPA's working relationship with
the Department of Justice and the United States Attorneys Office continues
to be governed by the June 1977  Memorandum  of Understanding between the DOJ
and EPA.  All criminal cases, collection and  seizure  actions, and warrants
for Inspections under FIFRA must be  filed by  the DOJ  and United States
Attorneys Office.  EPA Headquarters  and regional components are expected to
use their best efforts to Insure that a constructive  working relationship
is maintained with DOJ and to provide assistance to DOJ In the preparation
of those actions.  (For the procedures for  referring  actions Involving
criminal cases, collection, seizure, or warrants, see the Individual topics
in the manual.)

Food and Drug Administration (FDA).  FDA grants tolerances or exemptions on
pesticide products that are proposed to be  used in  a  manner that is likely
to result In residues in or. on food  or feed.  FDA surveillance programs
include the collection and examination of samples and data audits.  Upon
encountering foodstuffs containing pesticide  residues .that may have resul-
ted from pesticide misuse, the FDA will notify  the  appropriate EPA Regional
Office.  EPA will then proceed with  its own Investigation.
      Compliance/finzorcement             /-/           Guidance flsimsl  1983

-------
Chapter  Two	General Operating Procedun
                                           2-8            o«< <<«-*<>T funrnii1 1983

-------
 Chapter  Two
                                                             Organ"1 ynt"l o*v1  C?t">T"t8
                                                  OOP v inrr
                                _L
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 FIFBA  GoHpllance/Eafore
                                         2-9
                                                                                  1983

-------
        Chapter  Two
                                                                Organisational Charts
                                                   AHKUTE OMMflMTI*
                                                           f»
                                                    IMN. M
                       vrtet 9
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        FPBA
                                             2-10
                                                                          1983

-------
    Chapter  Two
                  Organizational Charts
                                              OFF ICC OF PCSTICIKS AND TOXIC SUBSTANCES
                                               OFFICE OF THE ASSISTANT AMINISTUATOft
                      OFFICE or PESTICIDES
                      ADO TOXIC SUBSTANCES
                     ASSISTANT ADMINISTRATOR
SCIENCE AMD POLICY
  ANALYSIS STAFF
                                                                   EXECUTIVE 01HECTOR
                                                                                                 SPECIAL ASSISTANT
                                                 NEAULATORT
                                                REFORM STAFF
      COMPLIANCE
      MOM I TOM IMS
        STAFF
                                                                                      -L
  ADMINISTRATION
BU06ET AND FEDERAL
  REGISTER STAFF
  CHEMICAL
COORDINATION
   STAFF
                                                                 DIRECTOR'S
                                                                   OFFICE
                                     POLICY AND 0RANTS
                                          UNIT
    FIFRA Co«pllance/Enf ore
2-11
                ial  1983.

-------
   Chapter Two
                                              Organizational  Charts
                                      OFFICE OF PESTICIDE PROGRAMS
                                         OFFICE OF THE DIRECTOR
                                            Office Director
                                         Deputy Office Director
  PROGRAM MANAGEMENT
  ft SUPPORT DIVISION
ADMINISTRATION WANCH
  RESOURCE NGMT.  ft
  EVALUATION BRANCH
INFORMATION SERVICES
       BRANCH
 ; "SYSTEMS -BRANCH
  BENEFITS ft USE
     DIVISION
   IBM ft PROGRAM
COORDINATION STAFF
NATIONAL LAB. AUDIT
   PROGRAM STAFF
     CHEMICAL
 OPERATIONS BRANCH
  SCIENCE SUPPORT
      BRANCH
                           ECONOMIC ANALYSIS
                                BRANCH
                                          POLICY ft SPECIAL PROJECTS
                                                    STAFF
HAZARD EVALUATION
    DIVISION

TOXICOLOGY BRANCH

EJPOSURE ASSESSMENT
BRANCH

ECOLOGICAL EFFECTS
BRANCH

RESIDUE CHEMISTRY
L BRANCH



SCIENCE INTEGRATION
STAFF

MANAGEMENT SUPPORT
STAFF

ADMINISTRATIVE
STAFF

                                        REGISTRATION DIVISION
                                              Director
                                           Deputy Director
                                           PROGRAM COORDINATION
                                                  STAFF
         TEAM
1
1C1DL-
D£ BRANCH

IAMAGEMENT
*12

lANAGEMENT
*15

lANAGEMENT
1 #16

lANAGEMENT
1 «17














mm


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'•'
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PRODUCT MANAGEMENT
TEAM 121

PRODUCT MANAGEMENT
TEAM §23

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TEAM #25

TECHNICAL SUPPORT
SECTION


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PRODUCT MAMAGFMFUT
TEAM 131

PRODUCT MANAGEMENT
..TEAMJJ2

TECHNICAL SUPPORT
SECTION










-------
 Chapter Two
                                                  Organizational Charts
                                             REGION I
                                                                  REPORTS TO
                                                            HQ OFFICE OF LEGAL AND
                                                             ENFORCEMENT COUNSEL
                                      REGIONAL ADMINISTRATOR
                                              DEPUTY
                                      REGIONAL ADMINISTRATOR
                 OFFICE OF
              INTERGOVERNMENTAL
                  LIAISON
                                            •«advisory  to)
                                               OFFICE  OF
                                             PUBLIC AFFAIRS
 ADMINISTRATIVE
SERVICES DIVISION
AIR MANAGEMENT
   DIVISION
HASTE MANAGEMENT
    DIVISION
HATER MANAGEMENT
    DIVISION
                                                              DEPUTY DIRECTOR
  ENVIRONMENTAL
SERVICES DIVISION
    EEO OFFICER
     PERSONNEL
      BRANCH
   PLANNING AND
    EVALUATION
      BRANCH
    OFFICE OF
 PESTICIDES AND
TOXIC SUBSTANCES
    STATE AIR
 PROGRAMS BRANCH
    STATE HASTE
  PROGRAMS BRANCH
  HASTE RESPONSE
  AND COMPLIANCE
      BRANCH
TECHNICAL SUPPORT
     BRANCH  -
  GRANTS ADM. AND
  FINANCE BRANCH
     OFFICE OF
4 PROGRAM SUPPORT
     MUNICIPAL
    FACILITIES
      BRANCH
 TECHNICAL SUPPORT
      BRANCH
   SURVEILLANCE
      BRANCH
                       HATER SUPPLY
                          BRANCH
                                           HATER  QUALITY
                                              BRANCH
JFJLFKA coapxiance/enxorc
                                 2-1J

-------
   Chapter  Two
                                                    Organisational Charts
                                                         REGION II
                                                                                                       REPORTS TO
                                                                                                 HQ OFFICE OF LEGAL Mffi
                                                                                                   ENFORCEMENT COUMSB.
                                                  REGIONAL ADMINISTRATOR
                                                     DEPUTY REGIONAL
                                                      ADMINISTRATOR
                   ASSISTANT REGIONAL
                     ADMINISTRATOR
                     FOR POLICY AND
                    DEPUTY DIRECTOR
      EEO OFFICER
PERSONNEL « ORGANIZATION
         •RANCH
  {•FORMATION SYSTEMS
 ENVIRONMENTAL  IMPACTS
         •RANCH
    POLICY < PROGRAM
   INTEGRATION BRANCH
    FINANCIAL MANAGEMENT
           BRANCH
FACILITIES « ADMINISTRATIVE
     MANAGEMENT BRANCH
         MMTNISTRATION
         , ttANCH
   PERMITS ADMINISTRATION
       .   BRANCH
   PLANNING « EVALUATION
               AIR AND WASTE
                MANAGEMENT
                 DIVISION
              Mffltn OUtECTOR
                 AIR PROGRAMS
                    BRANCH
                                                                                         to)
                                                             r—
                                                                   —  REGIONAL COUNSEL
                                                CONGRESSIONAL AND
                                            INTERGOVERNMENTAL LIAISON
                     MATER MANAGEMENT
                        DIVISION
                    • \
-------
Chapter  Two
                  Organ! imt*1 o*Mfi
                                    REGION III
                              REGIONAL ADMINISTRATOR

                                      DEPUTY
                              REGIONAL ADMINISTRATOR
       ASSISTANT REGIONAL
        ADMINISTRATOR
        FOR POLICY AND
          MANAGEMENT
           EEO OFFICER
           MANAGEMENT
         ADMINISTRATION
             BRANCH
          COMPTROLLER
           PERSONNEL
           MANAGEMENT
             BRANCH
         STATE PROGRAMS
             BRANCH
         ENVIRONMENTAL
         IMPACT BRANCH
                                                                             REPORTS TO
                                                                       HQ OFFICE OF LEGAL AND
                                                                         ENFORCEMENT COUNSEL
  -«(advisory to)
       OFFICE OF
   CONGRESSIONAL AND
   INTERGOVERNMENTAL
        LIAISON
       OFFICE OF
     PUBLIC AFFAIRS
                                 AIR  AND WASTE
                             MANAGEMENT DIVISION
                                DEPUTY DIRECTOR
                                 AIR  PROGRAMS AND
                                  ENERGY BRANCH
                                 AIR AND HASTE
                                   COMPLIANCE
                                     HASTE
                                   MANAGEMENT
                                     BRANCH
 HATER PROGRAM
   DIVISION
DEPUTY DIRECTOR
  ENVIRONMENTAL
SERVICES DIVISION
 DEPUTY DIRECTOR
  HATER PROGRAM
   MANAGEMENT A
  SUPPORT BRANCH
   MD/DE/VA/DC
      BRANCH
      PA/HY
      BRANCH
                                                         HATER SUPPLY
                                                        MATER PERMITS
                                                            BRANCH
   WESTERN REGIONAL
    LABORATORY AND
    ENVIRONMENTAL
        CENTER
     WHEELING, HV
   CENTRAL REGIONAL
      LABORATORY
    ANNAPOLIS,  ND
                         ENVIRONMENTAL
                           EMERGENCY
                             BRANCH
                                                                                AIR QUALITY
                                                                             MONITORING BRANCH
                                                                               HATER QUALITY
                                                                              MONITORING STAFF
TlfEA. Coapliance/Baxor
2-15
                   1983

-------
 Chapter Two
                                     Organizational Charts
                                       REGION IV
                                                                          REPORTS TO
                                                                    HQ OFFICE OF LEGAL AND
                                                                     ENFORCEMENT COUNSEL
                                  REGIONAL ADMINISTRATOR
                                          DtPUTT
                                  RESIDUAL ADMINISTRATOR

ASSISTANT REGIONAL
ADMINISTRATOR
FOR POLICY AND
MANAGEMENT

EEO OFFICER

OTIRQNNENTAL
ASSESSMENT
BRANCH

MANAGEMENT
BRANCH


PERSONNEL AND
, ORGANIZATION
BRANCH

POLICY AND
PROGRAM
EVALUATION BRANCH

BUDGET
OFFICE
              HATER MANAGEMENT
                  DIVISION
             .  DEPUTY DIRECTOR
                 FACILITIES
                 PERFORMANCE
                  BRANCH
                   MATER
                  SUPPLY
                  BRANCH
                                                         ^advisory to)
                                         REGIONAL
                                         COUNSEL
                                                            OFFICE OF
                                                        CONGRESSIONAL AND
                                                         EXTERNAL AFFAIRS
  AIR AND WASTE
    MANAGEMENT
     DIVISION
.  DEPUTY DIRECTOR
   EMERGENCY AND
 REMEDIAL RESPONSE
      BRANCH
     RESIDUALS
    MAMA6EMEKT
      BRANCH
  PESTICIDES AND
      TOXICS
      BRANCH
ENVIRONMENTAL
   SERVICES
   DIVISION
DEPUTY DIRECTOR
  ANALYTICAL
    SUPPORT
    •RANCH
                                                            •ECOLOGICAL
                                                               SUPPORT
  ENGINEERING
    SUPPORT
    BRANCH
                                    ^Uft MANAGEMENT
                                        iCRMCH
FHBA
                   2-16
             Orldi
1963

-------
Chapter Two
                                                        Organizational  Charts
                                            REGION V
                                                                             REPORTS TO
                                                                       HQ OFFICE  OF LEGAL AND
                                                                        ENFORCEMENT COUNSEL
                                       REGIONAL ADMINISTRATOR
                                              DEPUTY
                                       REGIONAL ADMINISTRATOR
                            OFFICE OF
                         PUBLIC AFFAIRS
                           GREAT LAKES
                        NATIONAL PROGRAM
                                                             •^(advisory to)
                                                                   REGIONAL
                                                                   COUNSEL
                                                    OFFICE OF
                                                 CONGRESSIONAL AND
                                                 INTERGOVERNMENTAL
                                                     LIAISON
PLANNING AND
MANAGEMENT
DIVISION



ENVIRONMENTAL
REVIEW
BRANCH

EQUAL
EMPLOYMENT
OFFICER
— 	
FINANCIAL
MANAGEMENT
BRANCH

PERSONNEL
BRANCH

MANAGEMENT
SERVICES
BRANCH

PLANNING AND
ANALYSIS
BRANCH
AIR MANAGEMENT
DIVISION



OFFICE OF
RADIATION
PROGRAMS

AIR
COMPLIANCE
BRANCH
	
AIR
PROGRAMS
BRANCH






HASTE
MANAGEMENT
DIVISION
DEPUTY DIRECTOR


WASTE
MANAGEMENT
BRANCH

REMEDIAL
RESPONSE
BRANCH

TOXIC
SUBSTANCES
BRANCH







r













HATER
MANAGEMENT
DIVISION
IEPUTY DIRECTOR


WATER
QUALITY
BRANCH

MUNICIPAL
FACILITIES
BRANCH

DRINKING HATER
/GROUNDUATER
PROTECTION
BRANCH







[













ENVIRONMENTAL
SERVICES
DIVISION
IEPUTY DIRECTOR


QUALITY
ASSURANCE
OFFICE

ENVIRONMENTAL
MONITORING
. BRANCH

CENTRAL
REGIONAL
LABORATORY

CENTRAL
DISTRICT
OFFICE

EASTERN
DISTRICT
OFFICE. OHIO

MICHIGAN FIELD
INVESTIGATIONS
SECTION















OFFICE OF
INSPECTOR GENERAL
NORTHERN DIVISION
DEPUTY DIRECTOR













                  •751
lii
            ore
2-17
1983

-------
Chapter  Two
                                                 Organizational  Charts
                                              REGION VI
                                                             REPORTS TO
                                                        HO OFFICE OF LEGAL AND
                                                        ENFORCEMENT COUNSEL
                                          REGIONAL ADMINISTRATOR
                                                 DEPUTY
                                         REGIONAL ADMINISTRATOR
                ASSISTANT REGIONAL
                   ADMINISTRATOR
                  FOR MANAGEMENT
                  DEPUTY 'DIRECTOR
        EEO OFFICER
         PERSONNEL
      SERVICES BRANCH
             • SAFETY
         OFFICER
           REGIONAL
   4J     COMPTROLLER
  RESOURCES MANAGEMENT
         BRANCH
     GRANTS ADMINISTRATION
            BRANCH
      MANAGEMENT SERVICES
            BRANCH
                      AIR AND HASTE
                        MANAGEMENT
                         DIVISION
                     DEPUTY  DIRECTOR
                        AIR BRANCH
    HAZARDOUS
4   MATERIALS
      BRANCH
                                                                  ((advisory to)
                                               OFFICE OF
                                           CONGRESSIONAL AND
                                           INTERGOVERNMENTAL
                                                LIAISON
  OFFICE OF
PUBLIC AFFAIRS
                           HATER
                         MANAGEMENT
                          DIVISION
                       DEPUTY DIRECTOR
                       ^PESTICIDES
                          TOXICS
                          BRANCH
                         CONSTRUCTION
                            GRANTS
                            BRANCH
                                              ENFORCEMENT
                                                BRANCH
                           •MMCH
                                            MATER QUALITY
                                              MANAGEMENT
                                                BRANCH
                                                JDPPLT
                                                BRANCH


/-.
• •)
ENVIRONMENTAL
SERVICES
DIVISION
DEPUTY DIRECTOR

EMERGENCY
RESPONSE
BRANCH

FEDERAL
ACTIVITIES
BRANCH

3NRVEUJJUCE
•WNCH

HOUSTON
•RANCH

:.«M
- "ABMW
~---'MMIGN

OFFICE OF
QUALITY
ASSURANCE
       Oomp 1aanrr/Bnro
                                2-18
       ftrldmce Manual 1983

-------
 Chapter Two
                                                Organizational Charts
                                            REGION VII
                                                                                REPORTS TO
                                                                          HQ OFFICE OF LEGAL  AND
                                                                           ENFORCEMENT COUNSEL
                                       REGIONAL ADMINISTRATOR
                                               DEPUTY
                                       REGIONAL ADMINISTRATOR
              ASSISTANT REGIONAL
                 ADMINISTRATOR
                FOR POLICY AND
                 MANAGEMENT
REGIONAL COMPTROLLER
       BRANCH
   ADMINISTRATIVE
   SERVICES BRANCH
    PERSONNEL  AND
 ORGANIZATION  BRANCH
ENVIRONMENTAL  REVIEW
       BRANCH
                         JL
                   AIR AND WASTE
                     MANAGEMENT
                      DIVISION
                  DEPUTY DIRECTOR
                                                              •<( advisory to)
                                      CONGRESSIONAL AND
                                      INTERGOVERNMENTAL
                                          RELATIONS
                                                               OFFICE OF
                                                             PUBLIC AFFAIRS
                      WATER
                    MANAGEMENT
                     DIVISION
                  DEPUTY DIRECTOR
                    AIR AND WASTE
                      COMPLIANCE
                        BRANCH
                        HASTE
                      MANAGEMENT
                        BRANCH
                         AIR
                        BRANCH
 ENVIRONMENTAL
    SERVICES
    DIVISION
                    CONSTRUCTION
                       GRANTS
                       BRANCH
                   DRINKING WATER
                       BRANCH
                       HATER
                     COMPLIANCE
                       BRANCH
       RAD
4  COORDINATION
        QA
     OFFICER
    LABORATORY
      BRANCH
                                                                    FIELD
                                                                 INVESTIGATION
                                                                    BRANCH
                                                                  EMERGENCY
                                                                  PLANNING 4
                                                               RESPONSE BRANCH
                                                     2-19
                                                 Cold*
                               1983

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Chapter  Two
                                             Organisational  Charts
                                            REGION nil
                                                                               REPORTS TO
                                                                         HQ OFFICE OF LEGAL AND
                                                                          ENFORCEMENT COUNSEL
                                        REGIONAL ADMINISTRATOR
                                               DEPUTY
                                        REGIONAL ADMINISTRATOR
                                                               •<(advisory to)
                                                        REGIONAL
                                                        COUNSEL
              ASSISTANT REGIONAL
                 ADMINISTRATOR
                 FOR POLICY AND
                  MANAGEMENT
           _L
      EEO OFFICER
    ADMINISTRATIVE
    SERVICES BRANCH
  GRANTS ft FINANCIAL
   MANAGEMENT BRANCH
  MANAGEMENT SYSTEMS
     AND ANALYSIS
   PERSONNEL AND
ORGANIZATION BRANCH
 COMPUTER SYSTEMS
      HUNCH
   ENVIRONMENTAL
 ASSESSMENT BRANCH
 RESOURCE PLANNING
  AND MANAGEMENT



AIR AND WASTE
MANAGEMENT
DIVISION

AIR PROGRAMS
BRANCH

TOXIC
SUBSTANCES
BRANCH

. I«ST£ -
M*BAGEMOT
BRANCH

OFFICE OF
RADIATION
. PROGRAMS
                                     CONGRESSIONAL AND
                                     INTERGOVERNMENTAL
                                        RELATIONS
                                                                   MONTANA
                                                                  OPERATIONS
                                                                    OFFICE
  OFFICE OF
PUBLIC AFFAIRS
                                            :•  MATER
                                            MANAGEMENT
                                             DIVISION
                                             COMPLIANCE
                                               BRANCH
                                             MUNICIPAL
                                             FACILITIES
                                               BRANCH
                                              'PROGRAMS
                                               BRANCH
                                           DRINKING HATER
                                               BRANCH

-v
ENVIRONMENTAL
SERVICES
DIVISION

FIELD
OPERATIONS
BRANCH

ANALYTICAL
SUPPORT BRANCH
(LABORATORY)

RESPONSE
BRANCH

DATA
ANALYSIS
•RANCH
                                                      2-20
                                               Cnldi
                    Manual 19B3

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Chapter Two
        Organizational Charts
                                            REGION IX
                                                                               REPORTS TO
                                                                         HQ OFFICE OF LEGAL AND
                                                                          ENFORCEMENT COUNSEL
                                        RESIONAL ADMINISTRATOR
                                               DEPUTY
                                        REfilONAL ADMINISTRATOR
                OFFICE OF POLICY
                  AND RESOURCES
                   MANAGEMENT
                      COMPTROLLER
                  MANAGEMENT SYSTEMS
                4  EVALUATION BRANCH
                                                              •<(idv1sory to)
                   REGIONAL
                   COUNSEL
    OFFICE OF
CONGRESSIONAL AND
INTERGOVERNMENTAL
     LIAISON
                                                               OFFICE OF
                                                             PUBLIC AFFAIRS
ADMINISTRATIVE
SERVICES DIVISION
i.

EEO OFFICER

HEALTH AND SAFETY
OFFICER

FOI COORDINATOR

PERSONNEL AND
ORGANIZATION
BRANCH

GRANTS AND PERMITS
, ADMINISTRATION
BRANCH

SUPPORT SERVICES
BRANCH
AIR
MANAGEMENT
DIVISION
DEPUTY DIRECTOR

AIR OPERATIONS
BRANCH

AIR PROGRAMS
BRANCH








TOXICS AND HASTE
MANAGEMENT
DIVISION
DEPUTY DIRECTOR

PROGRAMS
BRANCH

COMPLIANCE AND
. RESPONSE BRANCH






HATER MANAGEMENT
DIVISION
DEPUTY DIRECTOR

OFFICE OF
TERRITORIAL
PROGRAMS

PROGRAM SUPPORT
BRANCH

CALIFORNIA
BRANCH

ARIZONA, NEVADA
AND HAWAII
BRANCH

TECHNICAL
SUPPORT
                                                                                •RANCH
                                                   2-21
                             1983

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 Chapter Two
                  Organizational Charts
                                            REGION X
                                                                               REPORTS TO
                                                                         HQ OFFICE OF LEGAL AND
                                                                          ENFORCEMENT COUNSEL
                                      REGIONAL ADMINISTRATOR
                                              DEPUTY
                                      REGIONAL ADMINISTRATOR
                   ALASKA OFFICE
                   OREGON OFFICE
                   IDAHO .OFFICE
                 WASHINGTON OFFICE
                                                             <« advisory to)
                          REGIONAL
                          COUNSEL
       CONGRESSIONAL AND
       INTERGOVERNMENTAL
          RELATIONS
        OFFICE OF
      WBLIC AFFAIRS
MANAGEMENT
DIVISION

EEO OFFICER

'TWWCE
OFFICER

PERSONNEL

., j aBMJNISTRATm -'
- , .- . ^SERVICES . .
BRANCH

•-GRANTS AND
ADMINISTRATION
BRANCH
AIR AND HASTE
MANAGEMENT
; -DIVISION

AIR BRANCH

SUPERFUND
BRANCH

RCRA BRANCH

E • 'I
1 OUHATIOI WMNCM


                                                        MATER
                                                       DIVISION
                                                       COMPLIANCE
                                                         BRANCH
                     ENVIRONMENTAL
                   SERVICES DIVISION
                                                      CONSTRUCTION
                                                     GRANTS BRANCH
                                                     MATER QUALITY
                                                         BRANCH
                                                        WTEt
                                                        BRANCH
                        TECHNICAL
                         SUPPORT
                         BRANCH
                    FIELD OPERATIONS
                         BRANCH
                      (LABORATORY)
                        EMERGENCY
                        RESPONSE
PTVPA
2-22
19SS

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Chapter  Three
Compliance  Monitoring  Procedures
 Chapter Contents                                       Page


 1  Introduction                                        3-1
                                                   «

 2  Inspections                                         3-3

   Custodial Situations                                 3-3
   Noncustodial Situations                               3-4

   2a Records and Establishment Inspections                3-5

      Authority                                       3-5
      Scope                                           3-5
      Purpose                                         3-6
      Elements of an Inspection                          3-6

   2b Use/Misuse Investigations                          3-9

      General                                         3-9
      Authority                                       3-9


   2c Warrants                                        3-13

      Authority                                       3-13
      Policy                                          3-13
      Securing and Serving a Warrant                      3-15
      Exhibit 3-1:  Model Affidavit in Support of
                  Application for a Warrant              3-18
      Exhibit 3-2:  Model Warrant                        3-21


 3  Subpoenas                                           3-23
 FTFBA tfarr\1*tn**/*afarefmt>nr           3^1          C^Ufnf* "fTTIHl |««*

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Chapter Three	Contents
     Ompllmce/Enf

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Chapter Three
1     Introduction
Compliance monitoring is a term used to describe the wans  by which EPA
verifies conformance with statutory and regulatory requirements.   In the
context of FIFRA,  this includes the following types of activities:

     •  Books and  Records Inspections;

     •  Establishment Inspections; and

     •  Use/Misuse Investigations.

In the event that  an owner or operator of a regulated facility denies an
inspector entry to perform any of the above inspections,  FIFRA authorizes
officers or employees of EPA who have been duly designated  by the Adminis-
trator to obtain and execute entry and inspection warrants.

This chapter briefly outlines the procedures associated with these FIFRA
compliance monitoring activities.
FIFRA flfrMfl 1 w°*f ™f«*^r**»fiit'             3—1          Oi^y1*** Msnrnl 1983

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Chapter Three
Introduction
                                                                     1583

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Chapter Three
2     Inspections
Compliance inspections  are the  primary  enforcement mechanisms used to
detect and verify violations.   Facilities are selected for inspection
either under a neutral  administrative inspection scheme or "for cause."
(See definition of an unprogrammed  inspection in the Glossary.)  Selection
may be made, depending  on the circumstances, by Headquarters or Regional
Offices in cooperation  with States  with EPA enforcement grants.

Evidence obtained during an inspection  may result in the Agency taking any
of the following enforcement actions:

     •  Issuance of a notice of warning;

     •  Request for voluntary recall;

     •  Issuance of a stop sale,  use, or removal order (SSURO);

     •  Assessment of an administrative civil penalty;

     •  Institution of  a civil  court action; and

     •  Institution of  a criminal court action.
Custodial Situations
Compliance inspections  conducted  by EPA personnel under the authority of
FIFEA generally will not involve  the  need  to warn Individuals of their
rights under the fifth  amendment  of the United States Constitution.  The
fifth amendment provides that  "Ho person...shall be compelled in any
criminal case to be a witness  against himself."  Issues concerning this
right arise whenever a  person  is  taken  into custody or otherwise has his or
her freedom restricted  by law  enforcement  officers.  Since inspections
under FIFRA are generally not  conducted by law enforcement officers and do
not involve custodial situations, fifth amendment rights are not
implicated.
FIFRA Compliance/Enforcement             3-3           A^^m^-m Manual 1983

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Chapter Three	     	     Inspections
All individuals who conduct such Inspections should be aware of what
constitutes a custodial situation.  When an individual is under arrest, he
or she is clearly in custody.  However, a custodial situation may also be
created when, as a result of the demeanor and authority of the questioner
and the physical situation, a reasonable person would not feel free to
leave.  These types of situations should be avoided during an
administrative inspection.
Noncustodial Situations


Stateaents made to an inspector during a noncustodial administrative
inspection should be given voluntarily.  The term voluntary, as used in the
judicial sense, relates to the circumstances surrounding the investigation
and the taking of statements.  Such diverse factors as the following are
considered:

     •  Coercion or threats by the interviewer;

     •  Overbearing will of the interviewer;

     •  Promises of benefit by persons in authority;

     •  Deceit by the interviewer during the interrogation;

     •  The accused's age, experience, and level of education; and

     •  The accused's knowledge of his or her constitutional rights.
FIFBA ™^|««*jMM»»/|fnf"nrr(mnt             3-4           gnf^y««-» n^*™-"! 1983

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Chapter Three
2a    Records  and  Establishment
        Inspections
Authority
Sections 8(b) and 9(a) of  FIFRA authorize any officer or employee of EPA or
any State or political subdivision duly designated by the Administrator to
enter facilities under the scope of the Act in order to Inspect  and to copy
records, as veil as to inspect and to sample pesticides or pesticidal
devices that are packaged, labeled, and released for shipment.

Inspections must be conducted in a prescribed manner Including the:

     •  Presentation of credentials to owner, operator, or agent in charge;

     •  Presentation of a  notice of inspection detailing the suspected
        violation or cause for the inspection;

     •  Entry at a reasonable time and prompt completion; and

     •  Issuance of a receipt for samples in the case of an establishment
        or marketplace inspection.

Section 12(a)(2)(B) of FIFRA makes it unlawful for any person to refuse to
allow an EPA officer or employee to take a sample of any pesticide or to
inspect records or establishments covered by Sections 8 or 9.
Scope


Inspections conducted under Section 9 of FIFRA extend to the inspection of
facilities where pesticides or pesticidal devices are held for distribution
or sale.  Samples may be  taken of pesticides and pesticidal devices
released for shipment. Samples may also be taken of any container or label
for such pesticides or pesticidal devices.
FIFBA Qsaplisace/B&xorceaent             3-5           tp,iAm~~» Manual 1983

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Chapter Three	Records and Establishment Inspections
The scope  of  establishment Inspection does  not  extend Into manufacturing,
formulating,  repackaging,  or technical material storage areas  because FIFRA
does not provide  explicit  authority  to enter  these areas.   The inspector
does have  access  to  areas  (1) where  pesticides  or devices  are  packaged,
labeled, and  released for  shipment;  (2) where containers and labeling of
pesticides or devices are  stored;  and (3) where books and  records,  referred
to In Sections 8  and 9 of  the Act, are kept.

Records Inspections  conducted under  Section 8(b) of FIFRA  extend to the
Inspection and copying of .records  showing the delivery, movement, or
holding of pesticides or pesticldal  devices.

FIFRA limits  the  extent of records inspections  by providing that no regula-
tion or Inspection may extend to records of:

     •  Financial data;

     •  Sales data (other  than shipment data);

     •  Pricing data;

     •  Personnel data; and

     •  Research  data (other than  data relating to registered  pesticides
        or to information  on a pesticide for  which an application for
        registration has been made).
Purpose	..


The purpose  of  an inspection is  to  ensure  compliance with FIFRA and with
the rules promulgated  under FIFRA.   In summary,  the  Inspector's role is:

     •  To inform the  regulated  industry of  the  requirements  of the law;


     •  To document  suspected violations.



Elements of  an  Inspection	
The elements of FIFRA facility inspections can be  grouped  into the fol-
report preparation.   These elements are  common to  all  inspections,  but  the
emphasis given  to  the separate  elements  will vary  with the  needs  of the
Individual  Inspection.
F.TFKA &nl±*ace/Enxorcement             3—o            "r*ii.fnc* tts**"*1  1983

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Chapter Three	  Records and KstabJJ °**wnt  Inspections



Pre-Inapectlon Preparation

To ensure effective use of the inspector's  time, the  following procedures
are undertaken before beginning the inspection of a selected  facility:

     •  Establishing inspection objectives;

     •  Establishing the scope of the inspection;

     •  Conducting a review of Agency records;

     •  Preparing necessary documents; and

     •  Preparing sampling equipment and safety equipment.


Entry

Entry procedures are followed to obtain actual physical  entry into  the
facility.  Entry involves the following steps:

     •  Introduction;

     •  Presenting official credentials;

     •  Presenting the notice of inspection; and

     •  Managing denial of entry when necessary (see  Section  2c  of  this
        chapter).


Opening Conference

After entry, the inspector conducts an opening conference with the  facility
management.  During the opening conference, the inspector is  responsible
for the following activities:

     •  Discussing the objectives and scope of the Inspection;

     •  Advising of the availability of duplicate samples;

     •  Providing information on FIFRA and  its rules; and

     •  Planning meetings with personnel.
                                         3-7

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 Chapter Three	   Records and Eat*bH"*»^»nt
 Sampling and Documentation

 Reviewing facility records, taking official samples, and preparing documen-
 tation are the basic inspection activities.  It is these activities that
 provide the evidentiary support the Agency uses in enforcement actions.
 The inspector's responsibilities include:

      •  Targeting facility and locating records;

      •  Inspecting facility records;

      •  Preparing documentation of fli/»  inspection activities;

      •  Inspecting conditions and taking photographs, if necessary;

      •  Taking necessary samples, sealing samples, and establishing "chain
         of custody"; and

      •  Operating in a .safe and .efficient manner.


 Closing Conference

 The closing conference with facility officials enables the Inspector to
 prepare receipts, answer questions, and provide information about FIFBA.
 At  the closing conference, the inspector "wraps up" the inspection by:

      •  Writing necessary receipts;

      •  Advising that results of analysis of an official sample will be
         furnished if and when analysis  is made; and

      •  Discussing Inspection findings.


 Report Preparation

 All evidence must be organized and coordinated in a comprehensive, rele-
 vant, and accurate report including;
     •  Narrative report; and

     •  Other documentary support.

Suspected violations are to be documented in the above reports.  Compliance
«f *me-«vide«c*.  
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Chapter Three
2b     Use/Misuse Investigations
General
Investigations to determine whether pesticides are being properly used can
be divided into two  categories:

     •  Use Inspections.  This includes routine investigations or observa-
        tions made on a cross section of pesticide uses during or Immedi-
        ately following application.  The purpose of  use inspections is to
        develop data on the common practices of applying pesticides, to
        encourage the proper use of pesticides, and to determine whether
        pesticides are being used in accordance with  their directions.  It
        is Agency policy to obtain the consent of the owner, operator, or
        person In charge of the premises for this type of investigation.

     •  Misuse Investigations.  This Includes investigations of reported or
        suspected cases of pesticide misuse.  These investigations are con-
        ducted to develop evidence in support of enforcement actions
        arising from the use of a registered pesticide in a manner Incon-
        sistent with its labeling.  Entry should be on the basis of consent
        freely given or with a valid search warrant since information
        gathered to  support a subsequent enforcement  action must be protec-
        ted for admission into court as evidence.

Use/Misuse investigations will generally proceed through the same stages as
the records and establishment inspections described in this chapter.
However, for details on the procedures for entering and conducting a use/
misuse Investigation, please refer to the FIFRA Inspection Manual, Chapter
6, "Use/Misuse Investigations*"
authority	


Although Section 12(a)(2)(G) of FIFRA makes It clear  that the Agency is to
enforce against the misuse of pesticides, FIFRA does  not provide expressed
      Compll

-------
Chapter  Three	Use/Misuse Investigation
authority  to  conduct use/misuse investigations.   Nonetheless, the following
statutory  and common law doctrines  are  available to the Agency for conduc-
ting  these investigations.


Statutory  Basis

Where there is "probable cause" that  a  violation of one of the "use"
provisions of the Act has occurred, a warrant [FIFBA S9(b)*]  authorizing
entry f or  the purpose of /inspecting and sampling may be obtained.  (See
Section 2c of this  chapter.)

Section 9(a)  of  FIFRA authorizes entry  Into those places where pesticides
are held for  distribution and sale  for  the purpose of inspecting and sam-
pling pesticides that are (or have  been) packaged, labeled, and released
for shipment.  In the context of pesticide use inspections, Section 9(a)
permits entry into  establishments of  those persons who offer "for hire"
applicator services.   These types of  establishments would include the
                                                                or
applicator service vehicle  or any  other  service equipment used to hold the
pesticide for  distribution  or sale.
Common Law Basis

If the above statutory  authorities  do not  apply,  entry and sampling for
purposes of a use/misuse  Investigation may occur  only when one of the fol-
lowing common law doctrines  applies:

     •  Consent .  Consent must  be given  freely and voluntarily (not as a
               :«f dnr«ss,/ml»jepi»sentatlon,  cr ^coercion) ty the owner, ills
          i;ker ^«gent , *or  the -person -In •charge -of •the property or "premises .
        For repeated  Inspections at the  same  site, it Is necessary to
        obtain consent  for each entry and  sampling unless prior consent is
        given to  cover  all such inspections.
   Section 9(b)  of  FIFBA authorizes employees duly designated by the
   Administrator to obtain Inspection warrants in order to enter a facility
   for purposes  of JLaspectlng jmd.saapllng JJ there Is "probable -cause"  to
   evidence  necessary to  establish probable cause for an administrative
   warrant under Section  9(b)  of  FIFRA is  less than that necessary to
   obtain a  criminal search warrant,  sufficient evidence must be available
   to demonstrate that it is reasonable 'to conclude that specific
   provisions  of FIFBA have been  violated.
FIFBA Gampllmfff*nfvttt!*Bttt             3-10

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Chapter Three	    Use/Misuae Investigation
     •  Exigent Circumstances.   If  a  serious  situation exists,  such as the
        endangeroent of human health  or public safety occurring on private
        property, an inspector may  enter  the  property to assist in preven-
        ting the harm when:

        - There is Insufficient  time  to procure a warrant,  and
        - Consent cannot be readily obtained.

        This doctrine should be  used  only in  rare instances since it places
        a heavy burden on the Agency  to justify its  entry without author-
        ity.

     •  Plain View.  This doctrine  applies in those  Instances where an
        inspector has lawfully gained entry onto private property or pr«
        ises (such as to conduct monitoring or to follow up an  accident
        report) and subsequently encounters a violation in  his  or her
        "plain view."  The inspector  may  observe and document the violation
        so long as he or she stays  within the scope  of the  authorization to
        enter the property or premises.

     •  Open Fields.  An Inspector  may observe and document a violation
        occurring in an open area within  his  or her  view so long as the
        Inspector does not enter the  property on which the  violation is
        occurring.  For example, an inspector on a country  road can observe
        and prepare evidence on  a visible misuse that is occurring in a
        field adjacent to that road.
FUfMA Compliance/Enforcement             3-11          Quid*

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Chapter Three          	                    	Pae/Mlsnse Investigation

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Chapter  Three
2c     Warrants
A warrant can be used to gain entry Into  a  facility vhen facility officials
have denied entry to an inspector  or have withdrawn their consent to in-
spect during an Inspection.   In certain circumstances it may be necessary
to obtain a warrant prior to an Inspection.  A warrant is a judicial
authorization for an appropriate official (EPA inspector, State inspector,
U.S. Marshal, or other authorized  officer)  to  enter a specifically des-
cribed location and perform  clearly defined inspection functions.
Authority	


Section 9(b) of FIFRA authorizes  officers or employees duly designated by
the Administrator to obtain and execute warrants authorizing:

     "(1) entry for the purpose of  this section;

     "(2) inspection and reproduction  of all records showing the quantity,
          date of shipment, and the name of consignor and consignee of any
          pesticide or device found in the establishment which is adulter-
          ated, mlsbranded, 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 infor-
          mation, 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."
Policy	_____	


It is the policy of EPA to  obtain a warrant when all other efforts to gain
lawful entry have been exhausted.  This policy, of course, does not apply
to pre-inspection warrants.
                                        3-13

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 Chapter Three	___^^_	      Warrants
Marshall v.  Barlow's Inc.

In Marshall  v. Barlow's, Inc.,  436 U.S.  307 (1978), the Supreme Court
addressed the need for an administrative warrant when an Occupational
Health and Safety Administration (OSHA)  inspector sought entry into a
workplace where consent for the inspection was not voluntarily given by the
owner.  The  Court concluded that an administrative warrant was required to
conduct such regulatory inspections unless the industry is one with a
history of extensive regulation, such as liquor or firearms.

EPA guidance ^recognizes that, inspections conducted pursuant to authority
under  flrnA  may constitute an exception  to the Barlow's decision, due to
the long histroy of Federal regulation of pesticide Manufacture.  Although
the issue has not been tested,  as a Batter of policy, the Agency will apply
the requirements of Barlow's to all FIFRA inspections, Including
inspections  conducted by State  personnel.

According to Barlow's, a warrant may be  obtained where there is a specific
reason to think that a violation has been committed (i.e., where there is
probable cause auch as an employee's complaint or a competitor's tip).  A
warrant may  also be issued if the Agency can show that the establishment to
be Inspected has been selected  pursuant  to a neutral Inspection scheme.  To
meet Barlow's requirements and  to carry  out its duties under the Act, the
Agency has developed criteria to be used in selecting an activity for a
programmed (neutral) Inspection.  (See Appendix 1, Neutral Administrative
Inspection Scheme,  for details  of the criteria.)


Seeking a Warrant Before Inspection

A warrant may be obtained before the inspector sets forth to conduct the
Inspection. - ;m pre-dnspeetion wmrrant maty fre obtained :at the discretion of
tbe Kcgltmal Office If:

     •  A violation is suspected and could be covered up within the time
         needed to secure a warrant;

     •  Prior correspondence or other contact with the facility to be
         Inspected provides reason to believe that entry will be denied when
         the  Inspector arrives;  or

     • The  facility Is unusually remote from a magistrate or a district
         court, and thus obtaining a warrant would require excessive travel
Civil Versus  Criminal warrants
               *of ,£ne ^Ixsipetctlon Is^fiO'^dlxcovex and '^correc
procedures,  noncompliance with  regulatory  requirements,  a civil warrant
should  be secured if entry is refused.
FTFBA Campllanee/aworoement             3-14          Guidance r*""**1  1983

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Chapter Three	    Warrants
If the primary purpose of the inspection  is  to  gather  evidence for a
criminal prosecution and there is sufficient evidence  available to
establish probable cause for a criminal warrant,  then  a civil warrant
should not be used to gain entry.  Rather, a criminal  search warrant must
be obtained pursuant to Rule 41 of the Federal  Rules of Criminal Procedure
(Fed. R. Grim. P.).  (See Agency "Guidelines for  the Use of Administrative
Discovery Devices in the Development of Potential Criminal  Cases.")

Evidence obtained during a valid civil inspection is generally admissible
in criminal proceedings.
Securing and Serving an Administrative Warrant
The following procedures for obtaining and serving a warrant have been
developed in accordance with the Barlow's decision.


Important Procedural Considerations

     •  The application for a warrant should  be made as  soon as possible
        after the denial of entry or withdrawal of consent.

     •  In order to satisfy the requirements  of the Barlow's decision, the
        affidavit in support of the warrant must  Include a description of
        the reasons why the establishment has been chosen for inspection.
        The only acceptable reasons are specific  probable cause (e.g., an
        employee's complaint or competitor's  tip) or selection of the
        establishment for 'inspection pursuant to  a neutral administrative
        inspection scheme.

     •  A warrant must be served without undue delay and within the number
        of days stated (standard is 10 days). The warrant will usually
        direct that It be served during daylight  hours.

     •  Since the inspection is limited by the terms of  the  warrant, It is
        very Important to specify to the greatest extent possible the  areas
        Intended for Inspection, records to be Inspected, samples to be
        taken, etc.  A vague, overly broad warrant,  probably will not  be
        signed by the magistrate.

     •  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 U.S. Attorney*


Procedures for Obtaining a Warrant

     1.  Contact the Regional Counsel's Office.   The inspector should
         discuss with the Regional Counsel's  Office  the  facts regarding the
         denial or withdrawal of consent or the circumstances that gave
rlrXA. Oampllance/Birorcemcnt             3-15          Atijfmpr* jjpmml  ±983

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Chapter Three	Warrants
         rise to the need  for a pre-inspection  warrant.  'A joint
         determination will then be aade whether  or not  to seek a warrant.

     2.  Contact Headquarters Pesticides and Toxic Substances  Program
         Office.  The Regional Office should notify Headquarters  PTSCMS
         prior to obtaining a warrant.

     3.  Contact the United States Attorneys Office.  After  a  decision has
         been Bade to obtain a warrant, the designated regional official
         should contact the U.S. Attorney for the district in  which  the
         property is located.  The Agency should  assist  the  United States
         Attorneys Office in the preparation of the warrant  and necessary
         affidavits.

     4.  Apply for the Warrant.  The application  for  a warrant should iden-
         tify the statutes and regulations under  which the Agency is
         seeking the warrant.  The name and location  of  the  site  or  estab-
         lishment to be inspected should be clearly identified, and,  if
         possible, the owner and/or operator should be named.   The applica-
         tion can ibe a one- or two-page document  if all  factual require-
         ments for seeking the warrant are stated in  the affidavit,  and the
         application so states.  The application  is to be signed  by  the
         U.S. Attorney.

     5.  Prepare the Affidavits.  The affidavits  in support  of the warrant
         application are crucial documents.  Bach affidavit  should consist
         of consecutively numbered paragraphs that describe  all of the
         facts in support of warrant issuance.  Each  affidavit should be
         signed by a person with first-hand knowledge of all the  facts
         stated, most likely the Inspector.  An affidavit is a sworn state-
         ment that must be notarized or sworn to  before  the  magistrate.
         (See Exhibit 3-1.)

     6.  Prepare the Warrant for Signature.  The  draft should  be  ready for
         the magistrate's signature.  Once signed, the warrant is an
         enforceable document.  The warrant should contain a "return of
         service" or "certificate of service" that will  indicate  upon whom
         the warrant was served.  This part of  the warrant is  to  be  dated
         and signed by the Inspector after the  warrant is served. (See
         Exhibit 3-2.)

     7.  Serve the Warrant.  The warrant is served on the facility owner or
         the agent in charge and the inspection will  normally  commence or
         continue.  Where there is probability  Chat entry will still be
         refused* or where there are threats of violence, the  inspector
         should be accompanied by a U.S. Marshal.  In this case,  the U.S.
         Marshal Is principally charged with executing the warrant,  and the
         Inspector should .-abide .by the g«S.v Marsha] 's decisions.
     8.  Inspecting With the Warrant.  The inspection should be conducted
         strictly in accordance with the warrant.  If sampling is
         authorised, all procedures must be followed carefully, including
         presentation of receipts for all samples taken.  If records or
                                         3-16          flwMmr* •«—••••' 1983

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Chapter Three	    ga
         other property are authorized to  be  taken,  the  Inspector must
         issue a receipt for the property  and maintain an inventory of
         anything removed from the premises.  This inventory will be
         examined by the magistrate to ensure that the warrant's  authority
         has not been exceeded.

     9.  Return the Warrant.  After the inspection has been completed, the
         warrant must be returned to the magistrate.   Whoever executes the
         warrant (i.e., the U.S. Marshal or whoever  performs the  inspec-
         tion) must sign the return of service  form  indicating to whom the
         warrant was served and the date of service.   The executed warrant
         is then returned to the U.S. Attorney  who will  formally  return it
         to the issuing magistrate or judge.  If  anything has been physi-
         cally taken from the premises, such  as records  or samples, an
         inventory of such items must be submitted to  the court,  and the
         inspector must be present to certify that the inventory  is accu-
         rate and complete.
                                         3-17           Goldance Iff*"1  1983

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Chapter Three	*»*r»bit 3-1


          Model Affidavit In Support  of Application for a Barrant
                         UNITED  STATES  DISTRICT COURT

                                  DISTRICT  OF
                                       Docket  No._
                                       Case  No.
  la the natter of:
                                       Affidavit  in Support of
                                       Application for a Warrant
  State of
  County of
  [Name of Affiant)	, being  duly sworn upon his
  (her) oath, according to lav, deposes and  says:

        1.  I am a 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,
             airl tmtirnl"ir1ri^ all records showing She
                 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
                                                              A Marat* 1-

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Chapter Three	            	   Exhibit 3-1
                 of any person to produce records containing such infor-
                 mation, 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 vio-
                 lation of this Act."

        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 Sodenticlde Act, as amended.  This belief is based upon
            the following facts and Information:  (Summarize the reasons
            why a violation is suspected and the specific facts that give
            use to the probable cause, or the neutral administrative	
            inspection scheme used to select the facility for inspection.)
        4.  The (inspection, reproduction of records, sampling, or
            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 establishmment 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 inspec-
            tion, reproduction of records, sampling, or [optional, if
            needed] the issuance of a stop sale, use, or removal order.

        7.  A return will be made to the court at the completion of the
            inspection, reproduction of records, sampling, or the issu-
            ance of a stop sale, use, or removal order.

        8.  The authority for the issuance of the inspection warrant is
            Section 9 of the Federal Insecticide, Fungicide, sad Roden-
            ticide Act, as amended, and Marshall v. Barlow's Inc.,
            436 U.S. 307 (1978).
                                         3—19         Guidance Msnoal J.J93

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 Chapter Three   	         	 Exhibit 3-1
                            (Signature of Affiant)
                            (Title)
                            (Division)
                            legion ( )
                            United States Environmental Protection Agency
         Before ne, a notary public of the State of                     .
  County of                      , on this _______ day of	,
  19	, personally appeared	,
  and  upon oath stated that the facts set forth in this application are
  true to his (her) knowledge and .belief.

                            (Signature of Notary)	
                            A Notary Public of
                            My Commission Expires
FIFBA CoBpliance/Bnforcewent             3-20        f^^tinc^ Mr*-**1 1983

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Chapter Three
                                         Exhibit 3-2
                               Model Barrant
                      UNITED STATES DISTRICT COURT

                               DISTRICT OF
  In the matter of:
        Docket Mo.

        Case No.
        To
(name)
 Warrant for Inspection, Reproduction of
 Records, Stapling, and Issuing Stop
 Sale, Use, or Renoval Order of Pesticides
 or Devices Pursuant to the Federal
 Insecticide, Fungicide, and Rodentlclde
 Act,  as amended,  (7 U.S.C. $§135, 136)

	, 	(title)        	
        (division), Environmental Protection Agency, Region __
  other duly authorized enforcement officer of said division:
                                          and any
        Application having been made and probable cause shown, by (name
  of officer)        ,  for Inspection and sampling of packaged, labeled,
  released pesticides  or devices,  as veil 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 Rodentlclde Act, as amended, or should
  such records not be  available for Inspection, **! other available
  records and  information relating to such delivery, movement, or holding
  of any pesticide or  device that  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 that  Is in violation of the said Act; all
  within the establishment or place described as:

                               (Name of establishment or place)
                               (Address)
                                                  or
        Application having been made and probable cause shown, by
  of officer),  for inspection or sampling of pesticides used in vloJ
  tlon of the said Act,  at the place described as:
                               (Name  of person or property owner)

                               (Address)	
FXP1A Oompl
                /Bnfon
                  3-21
                                        1983

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Chapter Three      	                 	  Exhibit 3-2
  Pursuant to the Federal Insecticide,  Fungicide,  and Rodenticide Act,  as
  aaended, by the Federal Environmental Pesticide  Control Act of 1972,
  (hereinafter Federal Insecticide,  Fungicide,  and Rodenticide Act,  as
  amended), the Federal regulations  promulgated thereunder and the deci-
  sion  of  the Supreme Court in Marshall v.  Barlow's, Inc., 436 U.S.  307
  (1978),  you are authorized to enter (immediately) the above described
  premises upon presentation of this warrant  and therein to carry out the
  inspections, sampling, reproduction of records,  and/or issuance or
  surveillance of any stop,sale,  use,,or removal order described above.
                                        (Signature of Magistrate)


  (Date)


                               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

  Jncmectian «f >tb<-sarslil1«hsMiir'4r«CTl%ed invtirij -warrant-was -completed
           (date)    »
         ttre of person conflnctiag the inspection)
TCFRA. Compliance/Enforcement             3—22         ^Vldw*^ n*™**! 1983

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Chapter Three
3    Subpoenas
FIFEA does not provide for subpoena authority.*
   Except under PIFHA Section 6(d) where the Administrative Law Judge has
   subpoena authority to compel testimony or the production of documenta-
   tion from any person during a cancellation or change of classification
   proceeding held under FIFKA Section 6(b).
FIFEA Compliance/Bozorcement            3-23         ggf^y"* IJ««MI 1983

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 Chapter Three
V1FEA Compliance/Enforcement3-24 	'(^14^* M-T,~«I

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Chapter Four
Documentation of  Evidence
Chapter Contents	      	     Page
1  Introduction                                         4-1
2  Inspection File Review                                4-3

   Substantiation of Each Violation                         4-3
   Controlled Identification of Each Sample                  4-3
3  Review of Adequacy of Evidence                          4-7

   Initial Review of the ID' Jacket                          4-7
                        u> Jacket— rEnf or
    Case Beviev                                        4-11
   Additional Sources of Documentation               '       4-12
     CDapxiance/aaxorcaaent          4-1         Guidance nairrf' 1983

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Chapter Four
1     Introduction
Upon completion of a Section 9 inspection, pesticide enforcement inspectors
are required to organize  the documentary evidence gathered during this
inspection into a file commonly called the 10 (or Sample) Jacket.  The  ID
Jacket file includes all  the forms, reports, and documentary evidence
secured by the inspector  relating to an official pesticide or pesticidal
device ample.  Once compiled, the f He Is *ent to a Regional Case Develop-
ment Officer (RCDO) who reviews the inspection results for possible
enforcement action.
       uompiiance/laatorceaent             4-1          Guidance •*«""«'  1983

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  ChaPter  Four	_	Introducti,
PIFEA Gkmpllance/EnforceMnt             ^T           Guidance Manual 1983

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Chapter Four
2     Inspection File Review
To ensure the validity and quality of documentary evidence for an adminis-
trative or judicial enforcement proceeding, the RCDO must review the evi-
dence for objectivity, adequacy, and proper identification.  In some
Instances the RCDO will need an enforcement case review,  which could .
include the verification of the sample's pesticide registration and
labeling status,•• as yell as an interpretation of laboratory -test results.
In all cases, the RCDO must verify that all procedural safeguards were
implemented so as not to prejudice a possible enforcement action.
Substantiation of Each Violation
In most cases, a violation will be substantiated through a combination of
evidential sources.  The RCDO's review must seek to substantiate each
possible violation from the evidence supplied by the Inspector.  Whenever
aecessxry, the, RCDO should obtain from the inspector additional evidence or
clmrlf icatitm of existing "evidence.
Controlled Identification of Each Sample _


An Important aspect of any review by the RCDO is the determination that all
                                            y
Whenever a sample is taken,  the inspector prepares a Collection Report (EPA
Form 3540-7), which describes the sample collection process.  Information
required for the report Includes:

     •  Type of sample;

    «•  ^Snple amaber, ,«ub«mple mmber;

     •  Date of collection;

     •  Collection method;
FIFSA Compliance/Baxorceaent            4-3           Guidance Manual 1983

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Chapter Four	________^_	Inspection File Review
     •  Description of sample  (including  quantity collected, color, tex-
        ture, viscosity, etc.);

     •  Duplicate samples  (if  provided);  and

     •  Description of procedures  for  sealing sample.

Each ID Jacket will also be identified by a sample number.   The RCDO should
check the number to see if it  corresponds to the ID number on the Collec-
tion Report Form.

All samples that are to be used as  evidence should be  sealed with the offi-
cial EPA seal (EPA Form 7500-2).   The  seal is placed on the sample con-
tainer by the inspector to help preserve  the integrity of the sample.

A written receipt (EPA Form 3540-3) describing the sample obtained by the
inspector is Issued to the appropriate facility representative whenever a
sample is taken.  The receipt  may  also be used to verify that a dupllcatlve
sample was given the facility.  The ID Jacket may not  always include a copy
of the receipt.  If an enforcement action is considered, a copy may be
obtained from the Inspection Report that  was filed with the Regional
Office.

The two types of samples commonly  collected are official and investiga-
tlonal.

Official Samples.  These include samples  or documents  of pesticides or
devices that, If violative, serve  as a basis for legal action.  In general,
an RCDO should ensure that an  official sample:

     •  Was collected only from material  that had been "packaged, labeled,
        and released for shipment"  (see Glossary);

     •  Was representative of  the  lot  from which it was obtained; and

     •  Was Identified and officially  sealed so as to  maintain Its continu-
        ity and integrity  as court evidence.

Official samples include:

     •  Producer/Marketplace Samples.   Actual samples  of a pesticide or
        pesticidal device  collected by an inspector at the  producer, whole-
        sale, or retail level.

     •  Documentary Samples.   Copies of the label and/or labeling and
        copies of any records  showing  shipment of the  product and the re-
        sponsible parties.

     •  Post-Seizure Samples.  Actual  samples collected from a lot of mer-
        chandise that Is in the custody of a U.S. court.  A court order
        must be entered before sampling,  and these actions  must be carried
        out in accordance  with such orders.
FIFRA Compliance/Enforcement             4-4            Guidance Manual

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Chapter  Four    	Inspection File Review
     •   Induced  Samples.  Actual samples of pesticides or pestlcidal
         devices  that are not obtained by EPA official procedures (e.g.,
         notice of inspection, collection report, etc.).  These samples are
         usually  requested by mail.   An Induced sample is the least desir-
         able  method of obtaining a sample and should be used only when the
         other methods have been exhausted.

     •   Import Samples.   Actual samples of pesticides or pestlcidal devices
         that  are offered for Importation into the United States from a for-
         eign  port.   Proper documentation for Import shipments should
     .    Include  Customs  entry papers, foreign invoices, and records shoving
        movement from the port of entry.

     •   Use Samples*  Actual samples of the pesticide that are collected
         during a use inspection.  This type of sample may be field col-
         lected from a formulated pesticide, diluted pesticide, or as a res-
         idue  from plant  material, animal tissue, soil, water, etc.

Investlgatlonal  Samples.  These include samples of pesticides or devices
collected for special Invest!                                 .These samples
need not "be collected from lots or stocks that have been packaged, labeled,
and released  for shipment.  No legal action can be taken on investigational
samples.
FIFKA CoBpllance/Enforceaent             4-5           Guidance yg**"*1  1983

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Chapter Four	Inspection File Review
FIFSA CoBpllance/Eoforceaent             4-6           Guidance Manual 1983

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Chapter Four
3     Review  of Adequacy  of  Evidence
Initial Review of  the  ID Jacket
Once the RCDO has  received the ID Jacket, its contents must be reviewed in
    context of £he 'following
     •  Adequacy of  the documentation  (see below);

     •  Significance of violation (see Chapter Five for Level of Action
        Policy); and

     •  Vlolatlve history of the firm  (see Chapter Five for Level of
        Action Policy).  Violative history may be obtained from the FIFRA
        and TSCA Enforcement System  (FATES).
         of ~ £he  DOC^HUPD t B
The initial phase of the review will focus on two aspects of the documenta-
tion:

     •  That all necessary documentation and samples  have been provided;
        and

     •  That the documentation is adequate to prove the substance of the
                                           . fif
The purpose of  the review is to develop a recommendation for action on the
violation;  either to proceed with an enforcement action or to dismiss the
violation as not worthy of prosecution.

In some instances, review will  indicate possible violations not documented
by the inspection.  In these cases, the RCDO should .seek to secure the

            er  consultation with the inspector or forwarding the file to
Headquarters for an enforcement case review.  When a violation is dis-
covered that Is unrelated to the initial suspected violation, that new vio
lation should be pursued as a new action.
FIFRA Covpllance/Baforceaent            4-7          Guidance Manual  1983

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Chapter Four	Review of Adequacy of Evidence
Contents of the ID Jacket

The ID Jacket should normally contain  the  following  items:

Label of a Pesticide or Device.  The label  should either be an actual copy
(or photocopy) or a typewritten copy.  The  label  should be  Identified by
sample number, date of collection,  inspector  initials,  and, if appropriate,
subsample numbers.

Notice of Inspection (EPA Form 3540-2) or Warrant.   If  an enforcement
action is being considered, a copy  of  the  notice  of  inspection or warrant
may be obtained from the Establishment Inspection Report.  The notice and/
or warrant should be reviewed to ensure  the inspection  adhered to the terms
specified in the documents.

Receipt for Sample.  The written receipt should describe the sample and
verify that a duplicate sample, if  requested, was given to  the facility
official.  The RCDO should verify sample identification numbers.

Collection Report.  This is the official report of the  sample collection.
The following should be verified from  the  report:

     •  The ID number appearing on  the Collection Report should agree with
        the number on the ID Jacket.  For documentary samples, the notation
        "DOC" will appear after the ID number; for investigational samples,
        "INV" will appear after the ID number; for post-seizure samples,
        "P.S." will appear after the ID number; and  Import  samples will be
        identified by "Import";

     •  Date of shipment (from transportation records)  of the sample;

     •  Amount of the product before sampling (the amount on hand must be
        less than or equal to the amount shipped);

     •  Descriptions indicating number of samples and method of collection;

     •  Shipper of sample (from transportation records); and

     •  Reason for collection—either  to document a  suspected violation, or
        as part of a "Market Basket Survey" of products without accompany-
        ing documentation.

History of Official Sample (EPA Form 3540-17).  This document is placed In
the ID Jacket by laboratory personnel once  the physical cample has been
received by the laboratory for analysis.  It shows whether  the integrity of
the sample has been maintained during its stay at the laboratory.   Each
time the sample seal is broken and  resealed, it mist be noted on the form.

It is important for the RCDO to demonstrate that  none of the samples
Involved in the case preparation have been  tampered  with or contaminated
during collection, transit, storage, or analysis.  An accurate accounting
FIFBA Co*pliance/Enforce»ent             4-8           Guidance Manual 1983

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Chapter  Four   	Review of Adequacy of Evidence
must  be  maintained to trace the possession of each sample from the moment
of collection to its introduction as evidence*  Accountability can be
checked  by  reviewing the following documents:

      •   Receipt  for sample;

      •   Collection report; and

      •   History  of official sample.

Laboratory  Test  Methods..  Test .methods employed in the analysis of pesti-
cide  or  pesticidal device samples fall into two categories, official and
unofficial.

      •   Official Test Method.   Refers to a test method accepted by a recog-
         nized standard-setting organization, such as the Association of
         Official Analytical Chemists (AOAC) or the American Society for
         Testing  and Materials  (ASTM).

     •   Unofficial Test Method. ^Refers to a method that has not as yet
         been  accepted as a standard method but is employed by EPA in the
         analysis of a sample because other reliable test methods are not
         available.

Extreme  care  and Judgment should be exercised In preparing enforcement
cases when  unofficial test methods are used as the basis for evidence of a
violation of  the FIFRA.  Consultations with Headquarters Case Development
Officers (HQCDOs) are strongly recommended before proceeding with enforce-
ment  actions  in  these cases.

Laboratory  Test  Results.  Test results are placed in the ID Jacket upon
           o£ the <*naly.siB « " ' Tests .' Include :

      •   Sample Report of Analysis (EPA Form 3540-5), which shows the chemi-
         cal composition of the sample collected versus composition guaran-
         teed  by  the registrant.   Usually a cross-contamination will be
         conducted by the laboratory and the percentage of contaminants, If
         any,  noted;  and/or

     •   Efficacy test,  which shows the effectiveness jrf the product.

      ^Evidential 'Documentation.   Suspected violations may also be documen-
ted by the  Inspector using the following support methods:

     •   Affidavit .  Sworn statements taken by the Inspector relating to
         personal first-hand knowledge of a potential violation.  The affi-
         davit may be used to substantiate the violation or to set the cir-
                                the .gff.jfff fCT>T  Carttfol TWlCV VDOOU be
             «f the .affidavit .for 'evidence ±n support of an enforcement
        action.  The  person making  the  affidavit must sign It and be able
        to personally verify  the facts  contained in the statement.
FIFRA Co*pliance/Enforceaent             4-9           Guidance Manual 1983

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Chapter Four	Review of Adequacy of Evidence
        The object of an affidavit Is  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 sub-
        stantiate 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).  Review should emphasize  the admissibility of the
        affidavit in court.  This includes determining that the affidavit
        was properly executed and that it contributes  valid evidence to any
        contemplated proceeding.  The  affidavit itself should contain the
        following:

        -  Identity of the affiant;

        -  The reason why the affidavit was  taken;

        -  The pertinent facts in a simple narrative style, arranged In
           chronological order; and

        -  A concluding paragraph indicating that the  affiant read and
           understood the statement.

        In addition, any corrections made to the final copy must be ini-
        tialed by the affiant.

     •  Statements.  Similar in most respects to an  affidavit except that
        statements are not taken under oath.  Although not having the same
        weight in court, statements are taken for the  same reasons and
        under the same procedures as an affidavit.   Statements can be used
        to verify data collected during an inspection.  For example, a
        statement may be obtained from a facility representative as to a
        date of shipment.  Review should verify the  person's identity and
        the truth of the statement through a signature or some other writ-
        ten or verbal acknowledgment.

     •  Printed Matter.  This includes any brochures,  literature, labeling,
        or any other printed matter providing information concerning a pes-
        ticide or pesticidal device including claims,  directions for use,
        contents data, or promotional  information.   For pesticides, review
        of the printed matter directly relates  to terms and conditions
        specified in the registration.  Printed natter must be identified
        by Inspector's Initials, date  of collection, and related sample
        number.

     •  Photographs.  The documentary  value  of  photographs ranks high as
        admissible evidence.  Clear photographs of a relevant subject,
        taken in proper light and at proper  lens  setting provides an objec-
        tive record of conditions at the time of  Inspection.   Review must
        ensure that the photographs are clear,  objective,  and properly
        identified.  The photographs should  be  identified by location, pur-
        pose, date, time, Inspector's  initials, and  related sample number.
        This information should be recorded  on  the photographs,  or in the
        Inspector's field notebook, or both.
FIFBA Coapliaace/Eaforcewsnt             4-10          Guidance Manual  1983

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Chapter  Four  	Review of Adequacy of Evidence
         Drawings  and Maps.   Schematic drawings, maps, charts, and other
         graphic records  can be  useful in supporting violation documenta-
         tion.  They  can  provide graphic clarification of site location rel-
         ative  to  height  and size of objects,  and other information that, in
         combination  with samples,  photographs, and other documentation, can
         produce an accurate, complete evidence package.

         Review should ensure that  drawings and maps are simple and free of
         extraneous details.  Basic measurements and compass points should
         he -included  .to provide. .a, scale-, for interpretation.

                   Recording.   Records produced by an electronic or
        mechanical  apparatus can be entered as evidence.  Review of charts,
        graphs, and other "hard  copy"  should ensure relevance and
        Identity.   The data collected  should be identified by date of
        collection, inspector's  initials,  and related sample number.
Further Processing 
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Chapter Four  	Review of Adequacy of Evidence
Scientific Review.  If product defects  are  noted  as  a result  of laboratory
tests, the ID Jacket should be sent by  the  RCDO to Headquarters.   A review
will be conducted by Registration Division  personnel to  determine the sig-
nificance of the discrepancy as it relates  to  the sample's  chemical compo-
sition, efficacy, or toxiclty.

The Registration Division will enter the  registration status  and  pesticide
determination on the Enforcement Case Review Form (EPA Form 8500-7).   This
form will also include the product's accepted  name and the  name and address
of the registrant.  Written comments as to  labeling  discrepancies and sig-
nificance of test results are placed on EPA Form  8500-7A..   Copies of the
above forms are placed by the Registration  Division  into the  appropriate ID
Jacket and, along with testimony from the responsible Registration Division
official, may serve as evidence in court.

For any violations noted during an enforcement case  review, the RCDO should
consult the Level of Action Policy section  of  this manual (Chapter Five)
for guidance as to the appropriate enforcement response.
Additional Sources of Documentation


Frequently, additional information will be needed  in  order  to  complete  the
review of the ID Jacket.  In some cases this information  will  be  provided
by subsequent reports.  If not, the RCDO should  seek  to obtain the  addi-
tional information or elaboration from the most  knowledgeable  source.
Additional sources of documentation include:

     •  Establishment Inspection Report;

     •  Inspector's Narrative Report; and

     •  Inspector's Field Notebook.


Shipping Documentation

Section 8(b) of FIFRA provides authority to Inspect and copy all  records
showing the delivery, movements, or holding of a pesticide  or  pestlcidal
device.  This documentation, which Is often done as a part  of  a Section 9
Inspection, identifies the responsible party within the stream of commerce
who is suspected of a FIFRA violation.

Information that night be obtained from shipping records  includes:

     •  Identity of pesticide or device;

     •  Quantity sold, received, shipped, or stored;

     •  Dates sold, received, or shipped;
FIFRA Coapllance/Eoforceaent             4-12          Guidance Manual 1983

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 Chapter Four
   Review of Adequacy of Evidence
     •   Sources  of the pesticide or device;  and

     •   Transporter of the pesticide or device.

Records  providing  this information include:

     •   Bill  of  Lading;

     •   Freight  Bill;

     •   Parcel Post Cancellation Stamp;

     •   Invoice;

     •   Packing  Slip;

     •   Purchase Order;  and

     •   Receiving  Report.
  1
     I	
FIFRA Co«gHanc*/Knf orcenent
4-13
Guidance Manual 1983

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 Chapter Four
    Review of Adequacy of Evidence
FIFEA CompUance/Enforceaent
4-14
Guidance Manual 1983
         **••

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 Contents
1983

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 Chapter Four
1     Introduction
Upon completion of a Section 9 inspection, pesticide enforcement inspectors
are required to organize  the documentary evidence gathered during this
inspection into a file commonly called the ID (or Sample) Jacket.  The  ID
Jacket file includes all  the forms, reports, and documentary evidence
secured by .the .inspector  relating, to an official pesticide or pesticldal
device sample.  ;Qnce compiled, the file Is sent .to a -Regional Case Develop-
ment Officer (RCDO) who reviews the Inspection results for possible
enforcement action.
 rlFKA co»p u mire/ mtorccaent             4-1           Guidance Manual 1983

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          Four	Introduction
FURA CDMpliance/Enforce^nt             4^2         '    Guidance Manual 1983

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Chapter Four
2     Inspection File  Review
To ensure the validity and quality of  documentary evidence for an adminis-
trative or judicial enforcement  proceeding, the RCDO must review the  evi-
dence for objectivity, adequacy, and proper identification.  In some
Instances the RCDO will need an  enforcement case review, which could .
include the verification of the  sample's pesticide registration and
labeling status, ms -well AS an interpretation of laboratory test results.
In all rases, the RCDO must verify that all procedural safeguards were
implemented so as not to prejudice a possible enforcement action.
Substantiation of Each Violation
In most cases, a violation will  be  substantiated through a combination of
evidential sources.  The RCDO's  review must seek to substantiate each
possible violation from the' evidence supplied by the Inspector.   Whenever
neces-sarj., the JLCDO should obtain from the Inspector additional  evidence or
Controlled Identification of Each  Sample
An Important aspect of any review by the RCDO is the determination  that all
            'i1 1 if i^i 1 T *^**>^ l^^'TyiJ /and yrc^T-ffTff IT '                     '
Whenever a sample is taken, the Inspector prepares a Collection Report (EPA
Form 3540-7), which describes  the sample collection process.   Information
required for the report Includes:
     •  Type of sample;
     •  Date of collection;

     •  Collection method;
PIFRA Ompllance/Baforceaent            4-3           Guidance Manual 1983

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Chapter Four	 	Inspection File Review
     •  Description of sample  (Including  quantity collected, color, tex-
        ture, viscosity, etc.);

     •  Duplicate samples (If  provided);  and

     •  Description of procedures  for  sealing sample.

Each ID Jacket will also be identified by a sample number.  The RCDO should
check the number to see if it  corresponds to the ID number on the Collec-
tion Report Form.

All samples that are to be used as evidence should be sealed with the offi-
cial EPA seal (EPA Form 7500-2).   The  seal is placed on the sample con-
tainer by the inspector to help preserve  the integrity of the sample.

A written receipt (EPA Form 3540-3) describing the sample obtained by the
inspector is issued to the appropriate facility representative whenever a
sample is taken.  The receipt  may  also be used to verify that a dupllcative
sample was given the facility.  The ID Jacket may not always include a copy
of the receipt.  If an enforcement action is considered, a copy may be
obtained from the Inspection Report that  was filed with the Regional
Office.

The two types of samples commonly  collected are official and Investlga-
tlonal.

Official Samples.  These include samples  or documents of pesticides or
devices that, if violative, serve as a basis for legal action.  In general,
an RCDO should ensure that an  official sample:

     •  Was collected only from material  that had been "packaged, labeled,
        and released for shipment" (see Glossary);

     •  Was representative of  the  lot  from which it was obtained; and

     •  Was Identified and officially  sealed so as  to maintain its continu-
        ity and integrity as court evidence.

Official samples include:

     •  Producer/Marketplace Samples.   Actual samples of a pesticide or
        pestlcidal device collected by an Inspector at the producer, whole-
        sale, or retail level.

     •  Documentary Samples.   Copies of the label and/or labeling and
        copies of any records  showing  shipment of the product and the re-
        sponsible parties.

     •  Post-Seizure Samples.  Actual  samples collected from a lot of mer-
        chandise that is in the custody of a U.S. court.  A court order
        must be entered before sampling,  and these  actions must be carried
        out in accordance with such orders.
FIFRA Coapliance/Eiiforceaent             4-4            Guidance Manual

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 Chapter Four	Inspection File Review
      •   Induced Samples.  Actual samples of pesticides or pesticidal
         devices that are not obtained by EPA official procedures (e.g.,
         notice of inspection, collection report, etc.).  These samples are
         usually requested by mall.  An induced sample is the least desir-
         able method of obtaining a sample and should be used only when the
         other methods have been exhausted*

      •   Import Samples.  Actual samples of pesticides or pesticidal devices
         that are offered for importation into the United States from a for-
         eign port.   Proper documentation for import shipments should
         Include Customsentry.papers,,foreign invoices, and records shoving
        Movement from the port  of entry.

      •   Use Samples.  Actual samples of the pesticide that are collected
         during a use inspection.  This type of sample may be field col-
         lected from a formulated pesticide, diluted pesticide, or as a res-
         idue from plant material, animal tissue, soil, water, etc.

Invest!Rational Samples.  These include samples of pesticides or devices
collected for special Investigation or -information purposes.  These samples
need  not be collected from lots or stocks that have been packaged, labeled,
and released for shipment.  No  legal action can be taken on investigatlonal
samples.
FIFRA Compliance/Enforcement             4-5            Guidance Mf""*1  1983

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                                                     Inspection File Review
FCTA CoBpllance/Enf orceaent
4-6
Guidance
1983

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Chapter Four
3     Review  of Adequacy of  Evidence
Initial Review of  the  ID Jacket
Once the RCDO has  received the ID Jacket, its contents must  be reviewed in
the ^context of the following considerations:

     •  Adequacy of  the documentation (see below);

     •  Significance of violation (see Chapter Five for Level of Action
        Policy); and

     •  Violative  history of the firm (see Chapter Five for  Level of
        Action Policy).  Violative history may be obtained from the FIFRA
        and TSCA Enforcement System (FATES) .


Ajgquacy .of .the Jojctn"frit'
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Chapter Four      	         	Review of Adequacy of Evidence
Contents of the ID Jacket

The ID Jacket should normally contain  the  following  items:

Label of a Pesticide or Device.  The label should either be an actual copy
(or photocopy) or a typewritten copy.   The label  should be  identified by
sample number, date of collection,  inspector  initials,  and, if appropriate,
subsample numbers.

Notice of Inspection (EPA Form 3540-2)  or  Warrant.   If  an enforcement
action is being considered, a copy  of  the  notice  of  inspection or warrant
may be obtained from the Establishment  Inspection Report.  The notice and/
or warrant should be reviewed to ensure the Inspection  adhered to the terms
specified in the documents.

Receipt for Sample.  The written receipt should describe the sample and
verify that a duplicate sample, if  requested,  was given to  the facility
official.  The RCDO should verify sample identification numbers.

Collection Report.  This is the official report of the  sample collection.
The following should be verified from  the  report:

     •  The ID number appearing on  the  Collection Report should agree with
        the number on the ID Jacket.  For  documentary samples, the notation
        "DOC" will appear after the ID  number; for investigational samples,
        "INV" will appear after the ID  number; for post-seizure samples,
        "P.S." will appear after the ID number; and  import  samples will be
        identified by "Import";

     •  Date of shipment (from transportation  records)  of the sample;

     •  Amount of the product before sampling  (the amount on hand must be
        less than or equal to the amount snipped);

     •  Descriptions indicating number  of  samples and method of collection;

     •  Shipper of sample (from transportation records); and

     •  Reason for collection—either  to document a  suspected violation, or
        as part of a "Market Basket Survey" of products without accompany-
        ing documentation.

History of Official Sample (EPA Form 3540-17).  This document is placed in
the ID Jacket by laboratory personnel once the physical cample has been
received by the laboratory for analysis.   It shows whether  the Integrity of
the sample has been maintained during its  stay at the laboratory.   Each
time the sample seal is broken and  resealed, It mist be noted on the  form.

It is important for the RCDO to demonstrate that  none of the samples
Involved in the case preparation have been tampered  with or contaminated
during collection, transit, storage, or analysis.  An accurate accounting
FIFKA Compliance/Enforcement             4-8           Guidance Manual 1983

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Chapter  Four    	Review of Adequacy of Evidence
must be maintained to trace the possession of each sample from the moment
of collection to its introduction as evidence.  Accountability can be
checked by  reviewing the following documents:

     •  Receipt  for sample;

     •  Collection report; and

     •  History  of official sample.

Laboratory  Test  Methods.  Test .methods employed in the analysis of pesti-
cide or -pesticidal device samples fall into two categories, official and
unofficial.

     •  Official Test Method.   Refers to a test method accepted by a recog-
        nized standard-setting organization, such as the Association of
        Official Analytical Chemists (AOAC) or the American Society for
        Testing  and Materials  (ASTM).

     -»  Unofficial Test Method,  Refers to a method that has not as yet
        been  accepted as a standard method but is employed by EPA in the
        analysis of a sample because other reliable test methods are not
        available.

Extreme care  and judgment should be exercised In preparing enforcement
cases when  unofficial test methods are used as the basis for evidence of a
violation of  the FIFRA.  Consultations with Headquarters Case Development
Officers (HQCDOs) are strongly recommended before proceeding with enforce-
ment actions  in  these cases.

Laboratory  Test  Results.  Test results are placed in the ID Jacket upon
     •  Sample Report  of  Analysis  (EPA Form 3540-5),  which shows the chemi-
        cal composition of  the  sample collected versus composition guaran-
        teed by the  registrant.  Usually a cross-contamination will be
        conducted  by the  laboratory and the percentage of contaminants,  If
        any, noted;  and/or

     •  Efficacy test, which shows  the effectiveness  .of the product.

     ^Evtdcut.lsl Documentation.  "Suspected violations may also be documen-
ted by the inspector using  the  following support methods:

     •  Affidavit.   Sworn statements taken by the inspector relating to
        personal first-hand knowledge of a potential  violation.   The affi-
        davit may  be used to substantiate the violation or to set the cir-
        cumstances surrounding -the  violation.  £kr*ffll review saonld be
       *Bde«f>£be; affidavit far evidence Ja :*oppart of «n -enforcement
        action.  The person making  the affidavit must sign it and be able
        to personally  verify the facts contained in the statement.
FIFBA CoBpllance/Enforceaent             4-9           Guidance Manual 1983

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Chapter Four	Review of Adequacy of Evidence
        The object of an affidavit  is  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 sub-
        stantiate 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).  Review should emphasize the admlssibllity of the
        affidavit in court.  This includes determining that the affidavit
        was properly executed and that it contributes valid evidence to any
        contemplated proceeding.  The  affidavit itself should contain the
        following:

        -  Identity of the affiant;

        -  The reason why the affidavit was  taken;

        -  The pertinent facts in a simple narrative style, arranged in
           chronological order; and

        -  A concluding paragraph indicating that the affiant read and
           understood the statement.

        In addition, any corrections made to the final copy must be ini-
        tialed by the affiant.

     •  Statements.  Similar in most respects  to an affidavit except that
        statements are not taken under oath.   Although not having the same
        weight in court, statements are taken for the same reasons and
        under the same procedures as an affidavit.  Statements can be used
        to verify data collected during an inspection.  For example, a
        statement may be obtained from a  facility representative as to a
        date of shipment.  Review should  verify the person's identity and
        the truth of the statement  through a signature or some other writ-
        ten or verbal acknowledgment.

     •  Printed Matter.  This includes any brochures, literature, labeling,
        or any other printed matter  providing  information concerning a pes-
        ticide or pesticidal device  including  claims, directions for use,
        contents data, or promotional  Information.  For pesticides, review
        of the printed matter directly relates to terms and conditions
        specified in the registration.  Printed matter must be Identified
        by inspector's initials, date  of  collection, and related sample
        number.

     •  Photographs.  The documentary  value  of photographs ranks high as
        admissible evidence.  Clear photographs of a relevant subject,
        taken in proper light and at proper  lens setting provides an objec-
        tive record of conditions at the  time  of Inspection.  Review must
        ensure that the photographs are clear,  objective,  and properly
        Identified.  The photographs should  be identified  by location, pur-
        pose, date, time, Inspector's  initials,  and related sample number.
        This information should be  recorded  on the photographs,  or in the
        inspector's field notebook, or both.
FXFBa. Compliance/Enforcement             4-10          Guidance Manual  1983

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 Chapter Four   	Review of Adequacy of Evidence
         Drawings and Maps.  Schematic drawings, maps, charts, and other
         graphic records can be useful in supporting violation documenta-
         tion.   They can provide graphic clarification of site location rel-
         ative  to height and size of objects, and other information that, in
         combination with samples, photographs, and other documentation, can
         produce an accurate, complete evidence package.

         Review should ensure that drawings and maps are simple and free of
         extraneous details.  Basic measurements and compass points should
         be included to provide a scale for interpretation.

         Mechanical Recording.   Records produced by an electronic or
         mechanical apparatus can be entered as evidence.  Review of charts,
         graphs, and other "hard copy" should ensure relevance and
         identity.  The data collected should be identified by date of
         collection, inspector's initials, and related sample number.
Further Processing of the ID Jacket—Enforcement Case Review _


Once  the ID Jacket has been initially reviewed by the RCDO, further devel-
opment  of the case may be required at Headquarters.  If so, the ID Jacket
should  be sent to the appropriate HQCDO who serves as coordinator for the
enforcement case review process.  Aspects of the case that may require fur-
ther  processing include:

Product Registration Status.  The status of a pesticide (registered or not
registered) is determined by the Registration Division after a search of
their files.  In some instances the Region may also wish to know whether a
-pesticide registration d» suspended or •••"•••T'W

Pesticide or Device Determination.  When a suspected pesticide is not
registered or is not under a Section 5 experimental use permit, then a
determination is made by the appropriate Registration Division official of
whether the product is a pesticide.  Devices are reviewed to determine if
they  are pesticidal In nature and if so whether or not they are exempt from
EPA regulation.
                          trf "'•11 ;|MHTti I'dr T**«^ljf t*fJ3*»***4 -OT;prTt .of
inspection should be compared with the latest EPA-accepted label for that
pesticide and any major discrepancies noted.  If the latest accepted label
is  not  present at the Regional Office, it should either be requested from
Headquarters or the corresponding ID Jacket should be sent to Headquarters
for review.   In addition, questionable interpretations of label statements
should  be classified by the Registration Division before the Regional
FLFRA Cowpllance/Enforceaent             4-11          Guidance Mam">1 1983

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Chapter Four  	Review of Adequacy of Evidence
Scientific Review.   If product defects  are  noted as a result of laboratory
tests, the ID Jacket should be sent  by  the  RCDO to Headquarters.   A review
will be conducted by Registration Division  personnel to determine the sig-
nificance of the discrepancy as It relates  to  the sample's chemical compo-
sition, efficacy, or tozlclty.

The Registration Division will enter the  registration status and pesticide
determination on the Enforcement Case Review Form (EPA Form 8500-7).  This
form will also include the product's accepted  name and the name and address
of the registrant.  Written comments as to  labeling discrepancies and sig-
nificance of test results are placed on EPA Form 8500-7A.   Copies of the
above forms are placed by the Registration  Division into the appropriate ID
Jacket and, along with testimony from the responsible Registration Division
official, may serve as evidence in court.

For any violations noted during an enforcement case review,  the RCDO should
consult the Level of Action Policy section  of  this manual  (Chapter Five)
for guidance as to the appropriate enforcement response.
Additional Sources of Documentation


Frequently, additional information will be needed  in order to complete the
review of the ID Jacket.  In some cases this information will be provided
by subsequent reports.  If not, the RCDO should  seek to  obtain the addi-
tional information or elaboration from the most  knowledgeable source.
Additional sources of documentation Include:

     •  Establishment Inspection Report;

     •  Inspector's Narrative Report; and

     •  Inspector's Field Notebook.


Shipping Documentation

Section 8(b) of FIFRA provides authority to Inspect  and  copy  all records
showing the delivery, movements, or holding of a pesticide or pestlcldal
device.  This documentation, which is often done as  a part of a Section 9
inspection, identifies the responsible party within  the  stream of commerce
who is suspected of a FIFRA violation.

Information that night be obtained from shipping records  Includes:

     •  Identity of pesticide or device;

     •  Quantity sold, received, shipped, or stored;

     •  Dates sold, received, or shipped;
FIFRA CoBpllance/Enforceaent             4-12          Guidance Manual 1983

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 Chapter Four	          Review of Adequacy of Evidence








      •   Sources  of  the pesticide  or  devicej  and



      •   Transporter of the pesticide or device.



 Records providing this information include:



      •   Bill of  Lading;



      •   Freight  Bill;




      •   Parcel Post Cancellation  Stamp;



      •   Invoice;



      •   Packing  Slip;




      •   Purchase Order; and




      •   Receiving Report.
FIFEA Compliance/Enforcement4^DGuidance Manual 1983

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 Chapter Four	Review of Adequacy of Evidence
FZFRA Coapllance/Enforceaent4-14Guidance Manual 1983

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Chapter  Five

Determination  of  Appropriate
Enforcement  Response
Chapter Contents _ Page


1  Introduction                                        5-1

2  Level of Action Policy                                5-3

   Advertising Letters                                  5-3
   Notices of Detention                                 5-4
   Notices of Warning                                   5-4
   Terminations of Establishment Registrations              5-5
   Denials, Suspensions, Modifications, or
     Revocations of Applicator Certifications               5-6
   Recall Requests                                      5-8
   Stop Sale, Use, or Removal Orders                       5-10
   Civil Administrative Penalties                         5-13
   Injunctions                                         5-14
                                                  •  • 5—15
                                                     5-16
   Exhibit 5-1 :   Efficacy Standards and Level of Action
               Guidance for Disinfectants and
               Rodenticides                            5-18
   Exhibit 5-2:   Criteria for Determining the Gravity
               of a Use Violation for Purposes of
               a Certification Action                    5-21
FlFMA Compliance/Boxorceaent          5-1         Guidance Manual 1983

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 Chapter Five	       Contents
FIFRA Co«pl±aiice/Enforce«ent

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Chapter Five
1     Introduction
 Once  the  documentation  of a violation is complete and EPA personnel have
 determined  that an enforcement action is warranted, EPA must decide upon
 the appropriate level of action called for by the severity of the viola-
 tion.   There are  two categories of action—administrative and judicial.
 Generally,  the Agency uses administrative actions for violations of a
 lesser  nature, for first-time violators, or to obtain relief on short
notice,, &a  in the ;ca«e  of stop sale, use, and removal orders.  The Agency
reserves  judicial actions for use in violations of an especially egregious
 nature  that result in serious harm to human health or the environment, and
 for willful or repeated violations.

 Administrative levels of action Include the following:

     •  Advertising letters;

     •  Notices of detention under Section 17(c);

     •  Notices of warning under Sections 9(c)(3) and 14(a)(2);

   • ••;"•  flGeinlaationsvof «stabXlsh«eat7egl«CT«tlons Bonder 40 C.T.K. $167.3;

     •  Denials,  suspensions, modifications, or revocations of applicator
        certifications  under 40 C.F.R. 1171.11;

     •  Recall requests;

     •  Stop sale, use, or removal orders under Section 13(a); and

  -:-;,-.«  :d*U «dadal«tx*£ive ^enaltlea under Section 14(a).

The criteria for  the use of each of the above levels of action are dis-
cussed later in this chapter.  Specific procedures for preparing and
issuing these actions are found in Chapter Six, "Administrative Enforcement
Actions:  Notices of Violation and Administrative Orders," and Chapter
 Seven,  "Administrative  Enforcement Actions:  Civil Penalty Proceedings*"
                                         5-1           QafdOTC? Mr""*1 1983

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 Chapter  Five	Introduction


 Judicial actions may involve  either civil or criminal proceedings.  Civil
 proceedings include:

     •   Injunctions  under  Section 16(c);  and

     •   Seizures under  Section 13(b).

 Criminal proceedings are authorized under Section 14(b).  The criteria for
 the use  of Judicial  actions are also found later in this chapter.  Chapter
 Eight, "Judicial Enforcement:   Civil Actions,"  and Chapter Nine, "Judicial
 Enforcement:   Criminal  Actions," discuss  procedures for civil and criminal
 judicial proceedings.

 In addition, Exhibit 5-1 contains level of action guidance applicable to
 efficacy standards for  hospital or medical use  disinfectants and
 rodenticides.
FUBA Compliance/EnforcementP2           Guidance Manual 1983

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Chapter  Five
2     Level  of  Action Policy
Advertising Letters
An advertising letter is /.a letter Issued by EEA as notice to a company that
collateral literature concerning a product  (I.e., literature or advertising
that does not accompany the product)  bears  unaccepted pesticide statements
or pesticide or device claims.  An advertising  letter may be issued by the
Agency upon receipt of or knowledge of  such literature and without EPA
having in its possession an official  sample of  the pesticide or device
accompanied by the literature.  An advertising  letter should identify:

     •  The literature; and

     •  The unaccepted statements (If related to a registered product), the
        pesticide claims (if related  to an  unregistered pesticide), or the
        -device claims 
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Chapter Five         	Level of Action Policy
Notices of Detention
Section  17 of FIFRA authorizes  EPA to  refuse admission of a pesticide or
device being imported Into  the  United  States if EPA determines that such
pesticide or device violates  any  provisions  of the Act*  This refusal is
known as a Notice of Detention  and Hearing.   Upon receiving a copy of the
notice,  the Department of the Treasury,  through the Customs Service, will
refuse delivery to the consignee  and will  oversee destruction of any pesti-
cide or device refused delivery that is  not  exported by the consignee
within 90 days from the date  of the notice.   However, under the Customs
regulations for the enforcement of Section I7(c)  of FIFRA, the District
Director of Customs may release a shipment to the Importer or the Impor-
ter's agent before an EPA inspection of  the  shipment.  Such a release
occurs only upon execution  of a bond in  the  amount of the value of the
pesticide or device, plus duty.  Should  the  shipment subsequently be
refused entry and the importer  or agent  fails to  return the pesticide or
device,  the bond is forfeited.  A shipment released to the Importer cannot
be used or otherwise disposed of  until EPA makes  a determination of the
admlssibility of that shipment.
Notices of Warning


Section 14(a)(2) Notices of Warning

Section 14(a)(2) of FIFRA requires EPA  to use  a notice of warning In re-
sponse to the first civil offense committed  by a private applicator or
other person not covered under Section  14(a)(l).  Section 14(a)(l) covers
registrants, commercial applicators,  "for hire" applicators,  wholesalers,
dealers, retailers, and other distributors.  "For hire" applicators are
applicators who apply general use pesticides as a service In  controlling
pests but who do not deliver any unapplied pesticides.


Section 9(c)(3) Notices of Warning

Since the Agency Is attempting to concentrate  its pesticides  enforcement
resources on serious violations and repeat offenders,  EPA may also issue
notices of warning under Section 9(c)(3) of  FIFRA In response to  first-time
violations committed by those persons covered  by Section 14(a)(l), with the
following exceptions:

     •  The Agency should pursue a remedy more severe  than a  warning in
        response to first offenses that result in (1)  a real  risk to humans
        or the environment or (2) any actual harm stemming from the viola-
        tor's failure to exercise due care (i.e.,  the  degree  of care a  rea-
        sonably prudent person would exercise  in slmlllar circumstances);
        and
FIFRA Govp.Ll.ance/Enforcement             5-4           Guidance M**"*' 1983

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 Chapter Five  __^__^_______	Level of Action Policy
      •  The Agency should apply a remedy other than a notice of warning in
         the case of a violation by a person who has already been placed on
         notice of the existence of FIFRA or its requirements.  (EPA will
         consider a person to have been placed on notice if that person has
         been subject to a formal inspection by EPA personnel or has
         Interacted with the Agency by obtaining a product registration, an
         establishment registration, or any other similar license, permit,
         or  certification.)

The Agency, In Its discretion, may decide to issue a Section 9(c)(3)
warning  notice against persons .included in the latter exception or against
a repeat violator whose second violation is an extremely minor one, if EPA
enforcement officials believe that Justice will be served by employing such
a remedy.
Termination of Establishment Registration	


The  regulations related to the registration of pesticide-producing estab-
lishments  (40 C.F.R.  S167.3) state that an establishment registration will
remain  in  effect so long as the establishment continues to submit annual
pesticides reports.  If the establishment fails to submit a report in any
year, the  Agency may issue either a notice of warning or a civil penalty,
based on the provisions of FIFRA Sections 7(c)(l) and 12(a)(2)(L).*  A
notice  of  warning would be the typical action for a newly registered estab-
lishment that failed  to submit its initial pesticides report.  The Agency
should  initiate a civil penalty in response to the failure to file a
pesticides report on  the part of an establishment that previously filed at
least one  annual report and is thus on notice as to its continuing
        iblHty *'" ^***^TH^ ^ jt**i**t1^ - tio^ff not
        an  annual pesticides Teptart -within 20 days after the date of receipt
of the  notice of warning or civil penalty, EPA will initiate procedures to
terminate  the establishment registration, independent of the other action.


Non-Enforcement Termination

Termination of establishment registration may also occur upon request of

tos"gone or vlll go out of "business, no longer produces pesticides, or
otherwise  no longer falls under the purview of FIFRA Section 7.   In such
eases the  procedures  for terminating establishment registration are
                                                              30 4ay> of
  notification  of  establishment  registration;  subsequent reports are due by
  February  1 of each year.   The  Agency may,  however,  grant discretionary
  extentlons of up to 30 days  for  filing a report before the report is
  considered delinquent.
       ump 11 ance/ Bnzorccaent             5-5           Guidance Mar*"*1  1983

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 Chapter Five  	Level of Action Policy
strictly  technical and are  based  on  the  operating procedures of the FIFRA
and TSCA  Enforcement  System (FATES).   Termination of establishment regis-
tration in such situations  should not  be confused with termination for
cause.
Denials,  Suspensions, Modifications, or  Revocations  of Applicator
Certifications
The regulations relating to the certification of  pesticide applicators (40
C.F.R. Fart  171) authorize EPA to deny, suspend,  modify, or revoke feder-
ally issued  applicator certifications  If  the  certificate holder violates
FIFRA or its regulations.  The Agency  views an enforcement action affecting
certification status as a very strong  measure, to be taken only when the
"public health, interest or welfare warrants  immediate action" [40 C.F.R.
S171.11 (f)(5)(l)J.  Therefore, EPA will  deny, suspend, modify, or revoke a
certification only in response to serious violations or against persons
with a history of noncompllance.  The  Agency  may  take any of these actions
if it determines that an applicant for or holder  of  a certification has:

     •  Been convicted under Section 14(b) of FIFRA;

     •  Been subject to a final order  Imposing a  civil penalty under
        Section 14(a);

     •  Misused a pesticide;

     •  Made available for use, or used,  a registered pesticide classified
        for  restricted use.other than  in  accordance  with Section 3(d);

     •  Refused to keep and maintain records  required by 40 C.F.R. Part
        171;

     •  Made false or fraudulent records, invoices,  or reports;

     •  Failed to comply with any limitations  or  restrictions  on or in  a
        previously issued certificate; or

     •  Violated any other provision of FIFRA or  its regulations.


Denial/Revocations

The denial or revocation of a certification not only deprives  an applicator
of the authority to apply restricted use  pesticides  but  also,  as compared
to suspension of a certification, forces  the applicator  to  take additional
steps to acquire or re-acquire certification.   In addition,  the Agency  will
not consider an application to acquire or re-acquire certification for  a
period of not less than six months following denial  or revocation.   Thus
EPA will deny or revoke a certification only where a violation has  resulted

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 Chapter Five	Level of Action Policy
 In a fatality or created an Imminent danger of a fatality, where the viola-
 tor's certification has been suspended as a result of a previous violation,
 or where a person has made fraudulent records or reports.


 Suspensions

 When considering Invoking the less severe alternative of suspending a cer-
 tification, EPA personnel must determine whether it Is appropriate to pur-
 sue a suspension and for how long such suspension should be in effect.
 These determinations will depend upon the gravity of the violation in
 question.

 Suspension (Misuse Violation).  In suspending a certification due to an
 incident of misuse, EPA will refer to criteria for assessing the gravity of
 a  use violation (see Exhibit 5-2).  The gravity of a use violation is a
 function of:

      •  The risk of harm posed to human health and the environment by the
         ***j t*? -8 1 Ion ?
      •   The degree of misconduct exhibited by the violator.

The Agency will assign weightings, based on the gravity criteria, for each
use violation relative to the pesticide involved, the harm to human health
and/or  to  the environment, the history of noncompliance , and the culpabil-
ity of  the violator.  (For purposes of this section of the manual, EPA will
not distinguish between commercial and private applicators.  Consideration
of applicator status is Inherent in the policy in that suspensions have a
more  substantial Impact on commercial applicators, affecting their primary
business activity.)  The Agency will use the gravity value thus obtained to
decide  whether and for how long to suapend a certification, in accordance
      the following table:
     Total  Gravity Value        Enforcement Remedy

     A or below                 No action or Notice of Warning
     5 to 8                     Suspension of up to 2 months
     9 to 12                     .Suspension of .nbetmeen --2 -and 4 south
     13v«r  aiwve                 Suspension of Aataam 4 moA-•^"•p
To determine whether  the  term of  a  suspension should be at the higher or
lower end of the given ranges,  EPA  will  consider any gravity-related fac-
tors not accounted for in the gravity criteria.   In addition, EPA will con-
sider Xbe
        the v«TO3ic«tor* -;= Applicators ^dho 'wooM -1>e minimally affected by a
suspension,  such as  those  who  apply restricted  use  pesticides infrequently,
should receive longer suspensions  than  applicators  whose day-to-day
rLFHA. GoapJJ.ance/Enxorceaent             5-7            ^ii^rcf* Ma*1'"*1  1983

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Chapter Five	____^_	Level of Action Policy
business activities would be  severely  disrupted  by the loss of their
certifications.

Suspensions should generally  be pursued  against  individual applicators  in
lieu of a  Section 14(a)  civil administrative  penalty.   This, however, does
not preclude EPA from issuing both a suspension  as well as issuing a
warning letter or from assessing  a civil penalty against the employer of
the applicator in addition to suspending the  certification of the applica-
tor.

Suspension (Recordkeeping Violation).  EPA may also suspend certifications
of commercial applicators who violate  restricted use pesticides record-
keeping requirements [see 40  C.F.R. Sl71.11(c)(7); 40  C.F.R. Sl71.11(f)(1)
(ill)].  These violations do  not  lend  themselves to analysis utilizing
gravity of harm criteria.  Consequently,  EPA  will suspend the certifica-
tions of persons who fail to  maintain  restricted use pesticides records
based solely on gravity of misconduct  considerations.   The Agency will  .
assess suspensions of up to two months for the second  independent violation
resulting from the failure to maintain restricted use  pesticides records.
For each additional violation, two months  may be added to the term of the
suspension up to a limit of six months.   In cases where the violation
Involved keeping fraudulent records (i.e., where the violator intentionally
concealed or misrepresented the true circumstances and the extent of the
use of restricted use pesticides), EPA may revoke the  violator's certifica-
tion in response to the initial infraction.

If EPA decides to suspend certification,  it must notify the applicator  of
the time period during which  the  suspension will be in effect.   In order
for the suspension to function as a deterrent, the suspension should take
effect during the time when the applicator is most likely to be applying
restricted use pesticides. -
Recall Requests


No explicit authority exists in FIFRA for the recall of products.  The
effectiveness of a recall action, therefore, Is contingent on the
cooperation of the involved company.

Recalls should be initiated by EPA In all cases where available Information
Indicates that the product is either potentially hazardous when used as
directed or ineffective for the purposes claimed.  The Agency should
consider a recall of a product when, among other things, its use as
directed is likely to result in:

     •  Injury to the user or handler of the product;

     •  Injury to domestic animals, fish, wildlife, or plant life;
                         snt             3-8           Guidance Manual 1983

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 Chapter Five	Level of Action  Policy
      •  Physical or economic injury because of ineffectiveness or due  to
         the presence of actionable residues; or

      •  Identifiable adverse effect on the environment.

 EPA personnel must view a request for recall as a serious and extraordinary
 matter and must make a request for recall of a product only in those cases
 where the evidence clearly supports such action*  The initial decision that
 a product should be withdrawn from the market will be based on Information
 In the sample file Including laboratory analyses, staff evaluations and
 opinions, and such other information, as.may be available.and relevant.  All
 Information supporting & recall decision auat be Included in the official
 file.
 Formal and Informal Recalls

 There  are two types of recalls—formal and Informal.  Formal recalls are
 used for more serious problems when it is essential that EPA regional per-
 sonnel follow up the recall -with a visit £o the company,  formal recall
Involves EPA monitoring, detailed reporting by the company involved, and
 notification to State officials.  This type of recall is normally accom-
 panied by another enforcement action, generally a civil penalty.

 The Agency uses informal recalls in cases where a recall is necessary but
 the level of potential hazard is not great or when it is unlikely that sig-
 nificant amounts of the defective product remain in the marketplace.  An
 informal recall is conducted entirely by the company involved with no moni-
 toring by EPA or State officials.


 Level  of Recall Determination

The l«vel -of recall is the point in the distribution chain from which the
 product is to be recalled.  The determination of that point is based on the
 potential hazard, use pattern, and distribution pattern of the product.
 The following recall levels should be considered:

     •  Wholesale or First Point of Distribution.  This will normally
         Include all informal recalls and those formal recalls In which the
         product distribution is limited ftp^ cppf^'fTTtly -t^'-fM^gi?*"*^  dft"—
         ger Is.lov.

     •  Retail Level.  This will be the normal level for most formal re-
         calls.

     •  User Level.  This level will be requested only In  cases in which
         there is a known serious hazard to human health or the environment.
       Compliance/Enforcement              pg           Guidance Manual 1983

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 Chapter Five     	              	Level of Action Policy
 Scope  of  the  Recall

 EPA must  also consider  the  scope of the recall (i.e., the amount of the
 product that  the  recall will  cover).  In the case of labeling violations,
 the recall should include all of the product bearing the unacceptable
 labeling.  For  chemical violations, the recall should Include all of the
 product bearing the  same batch code(s) as the sample(s) found in viola-
 tion.  If the product is uncoded,  EPA will determine the scope of the
 recall after  contacting the responsible company.  After reviewing the
 firm's manufacturing and shipping  records, EPA personnel should be able to
 determine a range of manufacturing dates to include in the recall.

 The recall of a defective product  by the manufacturer or distributor is the
 most effective  and efficient  means of removing such a product from the mar-
 ket.   However,  since it is  strictly voluntary, the success of the recall
 program depends on the  Industry's  knowledge that:

     • EPA will  make a recall request only In those cases where there Is a
        likelihood of physical or  economic injury from the use of a product
        according to label  directions;

     • The Agency will use all legal means available to It to support or
        supplement any  recall request, including stop sale, use, or removal
        orders, seizures, and civil penalties; and

     • State officials will  cooperate with the Agency in the removal of
        such  products.
Stop Sale, Use, or Removal'Orders


A stop sale, use, or removal order  (SSURO) should  be  Issued by EPA if the
violation is of an ongoing nature and  threatens  to cause serious or
widespread harm.  This remedy Is not designed  to prevent future violations,
but rather is intended to limit the amount of  harm that  might result from a
violation.  In order to preserve the bearing rights of the  recipient of  an
SSURO, EPA should supplement the order with a  civil penalty assessment.

An SSURO Is among the most expedient and effective remedies available to
EPA In its efforts to prevent Illegal  sale, distribution, and use of pesti-
cides*  Its advantages over other actions (such  as seizures) are that:

     •  It may be issued without prior adjudication of the  violative char-
        acter of the product (i.e., EPA may issue  an  SSURO  simply when it
        has reason to believe that  the product is  in  violation of the Act);

     •  It is easier to prepare and issue than a seizure;
                r Enforcement5-10Guidance Manual 1983

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 Chapter Five   	Level of Action Policy



      •  It can be written so as to include future amounts of the product
         that may come into the custody of the person on whom the SSURO is
         served; and

      •  It can be easily adapted to particular circumstances.


 Criteria for Use

 The  language of Section 13(a) confers broad authority upon EPA to issue
 SSUROs.  The Agency may issue an,SSURO when any one of three situations
 exists:

      •  If, upon inspection or testing, EPA believes a product is in viola-
         tion of the Act;

      •  If EPA believes that a product has been or is intended to be dis-
         tributed or sold in violation of the Act; or
     .•  If EPA has /*a»vM»ii^ or suspended the registration of a product.

An  SSURO  is ordinarily issued by EPA without prior notice to the person
served.   Because an order is issued without notice, the actual or potential
danger to human health or the environment posed by the vlolative product or
situation must be both serious and imminent*  In addition, the danger must
require such urgent relief that there is no time to seek other remedies or
that other administrative remedies would be inappropriate.  Accordingly,
EPA officials must observe stringent guidelines in determining whether
issuance  of an SSURO is appropriate, as outlined below.

Mandatory Issuance of an SSURO.  The Agency must issue an SSURO against
persons who own, control, or have custody of pesticides in the .following
categories:

     •  Pesticides whose registrations have been cancelled or suspended by
        EPA, except cases In which the Agency has permitted the use of
        existing stocks, or where continued marketing presents no human
        health or environmental hazard;

     •  Pesticides for which there is reason to believe present a potential
        hazard tO. W**'n Or
            They are not registered,  or are so grossly overf emulated or
            adulterated, as to  present a serious health hazard, or
            They are packaged in Improper or damaged containers, or are so
            Inadequately labeled, as  to make safe or effective use unlikely
            or  impossible;
       fVnipllniirr/TTnfnrcrarnt          '   5-11           <><^ffrr*> fi^Tumi  ]Qip

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Chapter Five	Level of Action Policy
     •   Pesticides or devices with  labeling  that is materially misleading
         or fraudulent and, if observed by a  user, is likely to cause a
         life-endangering health hazard or serious adverse environmental
         condition.   (A pesticide lacking a restricted use label is an
         especially serious labeling violation.)   This provision includes
         labeling for products that:

         -  Are Ineffective for the  purposes  claimed,
         -  Are so chemically deficient as to affect deleteriously the pro-
           duct's efficacy, as determined by laboratory test results, or
         -  Bear false or misleading safety claims;

     •   Pesticides or hazardous devices* that are in violation of the Act
         and are the subject of a voluntary recall,  but which the respon-
         sible party refuses to remove, is recalcitrant in removing,  or is
         unable to remove from channels of trade;  and

     •   Pesticides or hazardous devices that are  in violation of the Act
         and for which a civil penalty has been issued but which have not
         been brought into compliance.

Discretionary Issuance of an SSURO.  EPA may exercise its discretion In
issuing  an SSURO in cases where a product either  is In violation of  the Act
or is intended to be distributed or sold in  violation of  the Act, and the
gravity of the violation is less than that required for issuance of  a
mandatory SSURO.  In addition to an analysis  of the relative severity of
the violation (or lack thereof), the following factors should be
considered:

     •  Whether the violation is another in  a series  of violations by the
        producer or distributor.  In cases of recidivism,  of uncorrected
        violations previously brought to the  individual's  attention,  or of
        repeated negligent conduct, an SSURO may  be appropriate where other
        enforcement remedies have failed to  bring about corrective action
        or where it is deemed necessary to prevent  continued marketing of
        the violatlve product;

     •  Whether the violation is easily corrected*   If it  appears that the
        individual is cooperative and can easily  remedy the  violation,  an
         SSURO may be unnecessary; and
* A hazardous device is one presenting a direct threat to human health or
  the environment by its use (e.g., a water treatment device whose labeling
  makes false, misleading, or fraudulent claims to purify raw well water or
  other untreated water supplies).  For nonhazardous devices (e.g., an
  electromagnetic rodent repelling device) that are misbranded, Agency
  policy is to complete civil penalty proceedings before issuing an SSURO.
  See December 19, 1979 Memorandum:  "Enforcement Actions Concerning
  Nonhazardous Pesticide Devices."
FJFSA Compliance/Enforcement             5-12

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 Chapter Five         	Level of Action Policy
      •  Who has custody of the product.  An SSURO may be more appropriate,
         and a violation more immediately cured, if the vlolative product is
         found at the producer level rather than at the retail level.

 In all other cases, EFA should consider an alternative enforcement remedy
 available under FLFRA.
 Use of SSURO for Minor Violations

 While EPA will usually reserve, the use of an SSURO to relatively serious
 violations, the need to Issue an SSURO may arise in certain cases involving
 minor violations.  For example, in the face of continued and repeated minor
 violations, or when several minor violations appear together on a label,
 EPA may decide to issue an SSURO to ensure that the product will be
 distributed only in compliance with the Act.


 Alternative Approaches

JIven In cases «here the existence of a serious violation would justify the
 issuance of an SSURO, the Agency may consider the use of alternative
 approaches to achieve compliance.  For example, certain pesticide labeling
 violations can be rectified through a voluntary recall by the manufacturer,
 and this may be the most expeditious way to prevent any harm to human
 health or the environment.  Thus, in certain cases that could legitimately
 call for the Issuance of an SSURO, particularly those concerned with
 labeling violations, EPA might first consider contacting the appropriate
 responsible party and negotiating a voluntary recall.
Civil Administrative Penalties
A civil penalty, as authorized by Section I4(a) of FIFRA, Is the remedy of
choice  for most violations.  A civil penalty should be proposed where the
violation presents (a real but not an extreme and unreasonable) risk to
humans  or the environment; is likely to be an isolated occurrence; was
apparently committed as a result of ordinary negligence, Inadvertence, or
   P   VP
         Involves a first offense under the Act by any registrant, commer-
         cial applicator, "for hire" applicator, wholesaler, dealer, re-
         taller, or other distributor (no prior warning Is required by FIFRA
         for violators In this category); or

         Involves a private applicator or other person, other than any j>arty
        . specified In Cfae :flz«t category, wholiBS zcced-red a .?riar warning
        or -cltatltjn -for * ^rlt>l«tlon of TTFRA.   
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 Chapter  Five  	              Level of Action Policy
 Injunctions
 Section  16(c) of FIFRA gives EPA the  authority to Initiate injunctive
 actions  before district courts.*  Because  an Injunction Is an extraordinary
 form of  relief, the Agency's arguments must be clear and compelling.  In
 Initiating a permanent injunction action,  EPA must Indicate to the court
 that:

     •   The Agency's administrative or other judicial enforcement remedies
         would be Inadequate either at restraining the violation or at pre-
         venting unreasonable risk to  human health or the environment;

     •   The Agency has, in fact,  already diligently exercised all appro-
         priate administrative remedies (such as SSUROs and civil penal-
         ties), yet the violation continues unabated; and

     •   Irreparable injury, loss,  or  damage will result if relief is not
         granted.

 In the case of a preliminary injunction or temporary restraining order, the
 Agency must additionally demonstrate  that:

     •   Immediate and Irreparable  Injury,  loss, or damage will result if
         relief is not granted; and

     •   There is a likelihood of  success at trial, based on facts before
         the court.

 Under FIFRA, there are a number  of specific circumstances that may justify
 Injunctlve relief.  These include but are  not  limited to:

     •   The violation of a Section 6  suspension order;

     •   The violation of an SSURO where a  civil penalty or criminal prose-
         cution would not provide a timely  or effective  remedy to deter  fur-
         ther violations;

     •   There Is continued production, shipment,  sale,  or use of an unreg-
         istered pesticide after  the Agency  has  taken civil or criminal
         action; and
   These actions may consist of permanent Injunctions, preliminary injunc-
   tions, or temporary restraining orders.  These types of injunctions are
   discussed in more detail in Section 4 of Chapter Eight.
FIFBA CbBpllance/Enforceaent             5-14          Guidance Manual 1983

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 Chapter  Five	    	    Level of Action Policy
         The Agency has exercised an enforcement remedy and a person con-
         tinues to make available for use a restricted use pesticide other
         than in accordance with FIFRA Section 3(d), or continues to use a
         pesticide In a manner inconsistent with its labeling or In a manner
         contrary to an experimental use permit.
 Seizures
Section  13(b)  of FIFRA gives EPA the authority to Initiate in rem condemna-
tion proceedings In district court.  Once a court grants the Agency's
request  for  authority to conduct a seizure, FIFRA Section 9(b) authorizes
duly designated Agency employees to obtain and execute warrants for the
purpose  of seizing any pesticide or device that is in violation of the Act.

Since  seizures are Judicial actions directed against vlolatlve products
rather than  against individuals, EPA may Initiate actions in court against:

     •  A pesticide that is adulterated, misbranded , unregistered, not
         colored or discolored as required, or bears claims or directions
         for  use that differ from those made in connection with its regis-
         tration;

     •  A device that is misbranded; or

     •  A pesticide or device that causes unreasonable adverse effects upon
         the  environment, even when used in accordance with requirements
         imposed by the Act.
The Above ^ezaapl«s «re eiaHar ; to  tnose that vould lead 'the Agency to ±n±-
£l*£e an 5SURO.  Because an SSDRO  gan be effected In less time and with
less preparation than that  required for a seizure, it Is  the preferred
remedy In  terms of expediency.   Nevertheless,  the Agency should consider
initiating a  seizure  In the following circumstances:

     •  The Agency has issued an SSDRO, but  the recipient of the order has
        not complied  with it;

   ,-*• ••jJB»..«af«acy::?has ••reason '.to %ell«ve tisa£ ^person, If lasued an SSDR0,
             not comply 'With It;
     •  There exists a  pesticide so hazardous  that  it  should be removed
        from the marketplace or place of use;

     •  The seizure will  be used to support  a  recall;  or
     ••  at Is necessary to 'dispose «f jmdac&s ccing held under van SSTJRO
        for 'which  the  responsible party  has  taken no corrective action and
        has expressed  an Intent  not  to take  corrective  action.
FIFRA Compliance/Enforcement              5-15           Guidance Manual 1983

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 Chapter  Five	          	Level of Action Policy
Criminal  Proceedings
 Section  14(b)  of FIFRA provides  EPA with  the  authority to proceed with
 criminal sanctions against violators of the Act,  subject  to the following
 distinctions:

     •  A registrant,  commercial applicator,  wholesaler,  dealer, retailer,
        or other distributor who knowingly violates  the Act is subject,
        upon conviction, to a fine  of not more  than  $25,000, or imprison-
        ment for not more than one  year,  or both.

     •  A private applicator or  other person  not  Included above who know-
        ingly violates the Act is subject, upon conviction, to a fine of
        not more than  $1,000, or Imprisonment for not  more than 30 days, or
        both.

 The Agency may Initiate criminal proceedings  in every  case in which EPA can
meet the stringent requirements  of  evidence and proof  leading to a convic-
 tion.  However, Agency policy, as well as pragmatic  resource considera-
 tions, argues against  the use of criminal sanctions  In any but the most
 serious Instances of environmental  misconduct,  as determined by the nature
 of the violation, the history of compliance on  the part of the responsible
 person, or the seriousness of the environmental consequences.
Considerations
There are a number of specific factors that the Agency must  carefully con-
sider before proceeding with a criminal prosecution.  (Chapter Nine,
"Judicial Enforcement:  Criminal Actions," addresses these considerations
in much greater detail.)

Knowledge.  The Agency must determine that the violator In question know-
ingly violated the statute.  That is, there must be evidence of intent  in
the commission of the violative act, rather than it merely being the  result
of accident or mistake.

Seriousness.  Criminal actions should be considered for the  most serious
types of environmental misconduct.  This consideration will  be judged by
reviewing the extent of environmental harm or human health hazard that
resulted from, or was threatened by, the prohibited conduct.   Factors such
as the duration of the conduct and the toxic!ty of the pollutants are
considered.  Also of significance in assessing the seriousness of the
conduct Is the impact—real or potential—upon EPA's regulatory function.

Deterrence.  The Agency must consider the Importance of and  need for  deter-
rence of criminal conduct, either on the part of a specific  person, or  on
the part of the larger community.  In the case of a serious  and willful
violation, the Interests of deterrence may well best be served by the
Imposition of criminal sanctions.
                                         5-16

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 Chapter Five	Level of Action Policy
 Compliance  History*  The compliance history of the person who is the sub-
 ject  of  possible criminal proceedings will enter into the Agency's deliber-
 ations.   While a history of noncompliance is not requisite for pursuing
 criminal sanctions, certainly criminal prosecution becomes more appropriate
 when  a history of noncompliance exists.

 Simultaneous  Actions.  The Agency may consider whether there is a need for
 criminal enforcement proceedings contemporaneous with a civil or adminis-
 trative  enforcement action, or whether one type of action alone will serve
 the situation in question.  While simultaneous proceedings are permissible,
 and there may be very compelling reasons  for pursuing both, the legal and
 practical difficulties Inherent In so doing argue against such an approach
except in the most extraordinary circumstances.


 Use of Criminal  Proceedings

 The Agency  has identified a number of specific situations that may be
 considered  of such a serious nature that  criminal prosecution Is
 particularly  appropriate.  To.list these  situations,  however, should not be
viewed , :«s pr<*cl ud ing crl ai na 1 .prosecution in circumstances not Included
below:
   t
     •   Failure  to report Information on  the unreasonable adverse effects
         of  a  registered pesticide;

     •   Falsification of  records;

     •   Violation of an order suspending  or cancelling a product
         registration;

     •   Violation of an SSURO;

    -:<•  Unlawful use«T)f  pesticides;  and

     •   Illegal  distribution of unregistered pesticides.
          illance/Enforcement             5-17   ~"      Guidance

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 Chapter  Five	Exhibit 5-1


               Efficacy Standards and Level of Action Guidance
                     for Disinfectants and Bodentlcldes
   Efficacy  standards  have  been developed and are being utilized by the
   Agency  for hospital or medical  use disinfectant products and rodentl-
   cldes.  The  efficacy standards  and level of action guidance for these
   two  types of pecticides  are  summarized below.   However, for the com-
   plete disinfectants laboratory  testing procedures and level of action
   guidance, refer  to  December  17, 1980 Memorandum:  "Regulation of Public
   Health  Belated Disinfectant  Products."  Additionally, for both disin-
   fectants  and rodentlcides, consult the civil penalty matrix In Appendix
   6 for the appropriate civil  penalty calculations.
                                Disinfectants
  Only hospital or medical use  products  that  make claims for Salmonella
  choleraesius, Staphylococcus  aureus, or  Pseudomonus  aeruglnosa* are
  tested.
  Level I Testing

  In Level I testing, 60 carriers must be  tested  against each of the
  above organisms with each of  three  samples, representing three
  different batches.  This amounts  to 180  carriers  per sample; a total
  of 540 carriers.

     •  Disinfectant Sample(s)

        Performance Standard;   A sample is determined  to fail efficacy
        testing if organisms on 2 or  more  of the  60 carriers are not
        destroyed.

        Level of Action;  For each  sample  that fails the above standard,
        an SSURO is issued on the batch from which  the sample was
        collected and a civil penalty Is issued for failure of the
        batch to meet the efficacy  requirements.
     Failure of a product to destroy Pseudomonus aeruginosa is considered
     equal to failure of a product to destroy Staphylococcus aureus or
     Salmonella choleraesius.
FIFKA Compliance/Enforcement        5-18               Guidance *a"«*i 1953

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 Chapter Five           	             	  Exhibit 5-1
      •  Disinfectant Product(s)

         Performance Standard:  A product provisionally fails efficacy
         testing if two or more of the three samples fail to destroy any
         test organism.

         Level of Action;  Level II testing is initiated for each product
         that fails the above standard.
  Level  II Testing

  If  a product fails Level I testing, five additional samples represen-
  ting five different batches are collected for testing at Level II.
  Sixty  carriers  are tested for each organism that the product fails to
  destroy  in Level I.

      •   Disinfectant Sample(s)

         Perfuimaure Standard:  A sample is determined to fail efficacy
         requirements if organisms on 2 or more of the 60 carriers are
         not destroyed.

         Level of  Action;  For each sample that fails the above standards,
         an SSUE.O  is issued on the batch from which the sample was col-
         lected, and a civil penalty is issued for failure of the batch to
         meet the  efficacy requirements.

      •   Disinfectant Product(s)

         Performance .Standard:  A -product is determined to fail efficacy
         tfRtlng If three or aore of the five •anples fail to destroy any
         organism.*

         Level of  Action;  Initiation of cancellation proceedings.
                                 Bodenticides
  Both single dose  (acute)  and  multiple  dose  rodentlcides that make
  claims for commensal  rodents  are  tested for efficacy.
           11 piotluet 'failures are based on  the  upper  bounds  of  the  95
     percent confidence level.   Consequently, a  sample must fail 5 out  of
     60 carriers  (not  2 out  of 60 as in Level I  tests) to  count  as a
     failure.
FIFSA Ompllance/Enforceaent         5-19                Guidance Manual  1983

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 Chapter Five		        Exhibit 5-1
      •  Acute or Single Dose

         Performance Standard;   The minimum standard is 90 percent rodent
         mortality after eight  days of testing for the product to be
         effective in commensal rodent control*

         Level of Action;  A civil penalty is issued for failure of the
         batch to meet the above efficacy requirements.

      •  Multiple Dose

         — Cereal or water baits

         Performance Standard;   The minimum standard is 33 1/3 percent
         bait  acceptance and 90 percent mortality in order for the product
         to be considered effective in a commensal rodent population.

         Level of Action;  A civil penalty is Issued for failure of the
         batch to meet the above efficacy requirements.

         — Paraffin blocks

         Performance Standard;   The minimum standard is 25 percent bait
         acceptance  and  80 percent mortality In order for the product to
         be  considered effective in a  commensal rodent population.

         Level of Action;   A civil penalty is Issued for failure of the
         batch to meet the above efficacy requirements.
FIFSA Compliance Eoforceaent           5-20            Guidance Manual  1983

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 Chapter Five
                                      Exhibit  5-2
            Criteria for Determining the Gravity of a Use Violation
                   for Purposes of a Certification Action
        Violation
Weighting
Activity
   GRAVITY OF HAKM

      Pesticide
     Harm to  Human
     Health
     Environmental
     Harm
             Toxicity—Category I pesticides,
             restricted use pesticides, or
             pesticides that are associated
             vith chronic health effects
             (mutagenlclty, oncogenicity,
             teratogenlclty, etc.)
                                        Toxicity—Categories II through
                                        IV, no known chronic effects
             Serious or widespread actual harm
             to human health
                                        Serious or widespread potential
                                        harm to human health
                                        Minor potential or actual harm to
                                        human health, neither serious nor
                                        widespread
             Substantial or widespread actual
             harm to the environment (e.g.,
             crops, water, livestock, wildlife,
             wilderness, or other sensitive
             natural areas)
                                        Substantial or widespread
                                        potential harm to the environment
                                       Hiirar potential or actual harm to
                                        the  environment,  neither wide-
                                        spread  nor  substantial
FIFEA Compliance/Enfor
          5-21
ui
                   1983

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 Chapter  Five
                                       Exhibit 5-2
        Violation
Weighting
Activity
   (XAVITY OF MISCONDUCT

      Noncompliance
      History
      Culpability
                               2


                               0
                               2


                               0
             More than one prior  violation of
             FIFRA by the applicator
             One prior violation
             No prior violations
             Knowing or willful violation
             Violation resulting from negligence
             Violation was neither knowing nor
             willful and did not result from
             negligence; good faith efforts
             made to comply with the law
FIFRA CoMpllance/Enf orceaent
          5-22
Guidance
                   1933

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Chapter  Five

Determination  of  Appropriate
Enforcement  Response
Chapter Contents	Page


1  Introduction                                        5-1

2  Level of Action Policy                                5-3

   Advertising Letters                                  5-3
   Notices of Detention                                 5-4
   Notices of Warning                                   5-4
   Terminations of Establishment Registrations              5-5
   Denials, Suspensions, Modifications, or
    Revocations of Applicator Certifications               5-6
   Recall Requests                                      5-8
   Stop Sale, Use, or Removal Orders                       5-10
   Civil Administrative Penalties                         5-13
   Injunctions                                         5-14
   Seizures                                           . .5-15
   'Criminal "Proceedings                                 5-16
   Exhibit 5-1:  Efficacy Standards and Level of Action
               Guidance for Disinfectants and
               Rodenticides                            5-18
   Exhibit 5-2:  Criteria for Determining the Gravity
               of a Use Violation for Purposes of
               a Certification Action                    5-21
FIFKA Compliance/enxorceaent           >-i

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 Chapter Five	   Contents
PIFRA Compliance/Enforcement5-liGuidance Manual  1983

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Chapter Five
1     Introduction
 Once  the documentation  of a violation Is complete and EPA personnel have
 determined  that an enforcement action Is warranted, EPA must decide upon
 the appropriate level of action called for by the severity of the viola-
 tion.  There are two categories of action — administrative and judicial.
 Generally,  the Agency uses administrative actions for violations of a
 lesser nature, for first-time violators,, or to obtain relief on short
 notice, as  in The case  of stop sale, use, and .removal orders,  The Agency
Yeserves judicial actions for use in violations of an especially egregious
 nature that result In serious harm to human health or the environment, and
 for willful or repeated violations.

 Administrative levels of action include the following:

     •  Advertising letters;

     •  Notices of detention under Section 17(c);

     •  Notices of warning under Sections 9(c)(3) and 14(a)(2);

     »  3ez3BlAa£lonsAf««tafall«fameisr 'registrations under 40 C.F.R. $167.3;

     •  Denials, suspensions, modifications, or revocations of applicator
        certifications  under 40 C.F.R. S171.11;

     •  Recall requests;

     •  Stop sale, use, or removal orders under Section 13(a>; .and

                                       -airier "Section 14(a).
The criteria for the use of each of the above levels of action are dis-
cussed later in this chapter.  Specific procedures for preparing and
issuing these actions are found in Chapter Six, "Administrative Enforcement
Actions:  Notices of Violation and Administrative Orders," and Chapter
Seven, "Administrative Enforcement ArMnnn *  filviJ rcnaltjr JFrocardtTigt • *
                    Eorceaent             5-1           Gn±4w?e ¥~*n*i 1933

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Chapter Five	Introduction


Judicial actions may involve either  civil  or  criminal proceedings.  Civil
proceedings include:

     •  Injunctions under  Section  16(c); and

     •  Seizures under Section  13(b).

Criminal proceedings are authorized  under  Section 14(b).  The criteria for
the use of judicial actions are also found later in this chapter.  Chapter
Eight, "Judicial Enforcement:   Civil Actions,"  and Chapter Nine, "Judicial
Enforcement:  Criminal Actions," discuss procedures for civil and criminal
judicial proceedings.

In addition, Exhibit 5-1 contains level of action guidance applicable to
efficacy standards for hospital or medical use  disinfectants and
rodenticldes.
FURA Compliance/Enforcement             5-2           Guidance Manual 1983

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Chapter  Five
2     Level  of  Action Policy
Advertising Letters
.An advertising letter la a letter Issued by EPA «e notice to a company that
collateral literature concerning a product (I.e., literature or advertising
that does not accompany the product)  bears unaccepted pesticide statements
or pesticide or device claims.  An advertising  letter may be issued by the
Agency upon receipt of or knowledge of such literature and without EPA
having in its possession an official  sample of  the pesticide or device
accompanied by the literature.  An advertising  letter should Identify:

     •  The literature; and

     •  The unaccepted statements (if related to a registered product), the
        pesticide claims (if related  to  an unregistered pesticide), or the
      -v device clalas ,
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Chapter Five	Level of Action Policy
Notices of Detention
Section  17 of FIFRA authorizes  EPA to  refuse admission of a pesticide or
device being imported into  the  United  States if EPA determines that such
pesticide or device violates any  provisions  of the Act.  This refusal is
known as a Notice of Detention  and Hearing.   Upon receiving a copy of the
notice,  the Department of the Treasury,  through the Customs Service, will
refuse delivery to the consignee  and will  oversee destruction of any pesti-
cide or device refused delivery that is  not  exported by the consignee
within 90 days from the date of the notice.   However, under the Customs
regulations for the enforcement of Section 17(c)  of FIFEA, the District
Director of Customs may release a shipment to the Importer or the Impor-
ter's agent before an EPA inspection of  the  shipment.  Such a release
occurs only upon execution  of a bond in  the  amount of the value of the
pesticide or device, plus duty.  Should  the  shipment subsequently be
refused entry and the importer  or agent  falls to  return the pesticide or
device,  the bond Is forfeited.  A shipment released to the Importer cannot
be used or otherwise disposed of  until EPA makes  a determination of the
admlsslbillty of that shipment.
Notices of Warning	


Section 14(a)(2) Notices of Warning

Section 14(a)(2) of FIFEA requires EPA  to  use  a  notice  of warning In re-
sponse to the first civil offense committed  by a private applicator or
other person not covered under Section  14(a)(l).   Section 14(a)(l) covers
registrants, commercial applicators,  "for  hire"  applicators,  wholesalers,
dealers, retailers, and other distributors.  "For hire" applicators are
applicators who apply general use pesticides as  a service In  controlling
pests but who do not deliver any unapplied pesticides.


Section 9(c)(3) Notices of Warning

Since the Agency Is attempting to concentrate  Its pesticides  enforcement
resources on serious violations and repeat offenders, EPA may also Issue
notices of warning under Section 9(c)(3) of  FIFRA In response to  first-time
violations conmltted by those persons covered  by  Section 14(a)(l), with the
following exceptions:

     •  The Agency should pursue a remedy  more severe Chan a  warning in
        response to first offenses that result In (1) a real  risk to humans
        or the environment or (2) any actual harm stemming from the viola-
        tor's failure to exercise due care (i.e.,  the degree  of care a  rea-
        sonably prudent person would exercise  in  simillar  circumstances);
        and
       Mpllaneg/BiforeMent;             5^4     "      Qifdg"**? Manual

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Chapter Five	Level of Action Policy
     •  The Agency should apply a remedy other than a notice of warning In
        the case  of a  violation by a  person who has already been placed on
        notice  of the  existence of FIFRA or Its requirements.  (EPA will
        consider  a person to  have been placed on notice If that person has
        been subject to  a formal Inspection by EPA personnel or has
        Interacted with  the Agency by obtaining a product registration, an
        establishment  registration, or any other similar license, permit,
        or certification.)

The Agency, in  its discretion,  may decide to issue a Section 9(c)(3)
warning notice  against persons .Included In the latter exception or against
a repeat violator whose  second  violation is an extremely minor one, if EPA
enforcement officials  believe that justice will be served by employing such
a remedy.
Termination of Establishment Registration


The regulations related  to  the  registration of  pesticide-producing estab-
lishments (40 C.F.R.  S167.3) state that an  establishment  registration will
remain din effect so long as the establishment continues to  submit  annual
pesticides reports.   If  the establishment falls  to  submit a report in any
year, the Agency may  issue  either a notice  of warning  or  a  civil penalty,
based on the provisions  of  FIFRA Sections 7
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Chapter Five 	Level of Action Policy
strictly  technical and are based  on  the  operating procedures of the FIFRA
and TSCA  Enforcement  System  (FATES).   Termination of  establishment regis-
tration in such situations should not  be confused with termination for
cause.
Denials, Suspensions, Modifications, or  Revocations  of Applicator
Certifications
The regulations relating to the certification of  pesticide applicators (40
C.F.R. Part  171) authorize EPA to deny,  suspend,  modify,  or revoke feder-
ally issued  applicator certifications if the certificate  holder violates
FIFRA or its regulations.  The Agency views an  enforcement action affecting
certification status as a very strong measure,  to be  taken only when the
"public health, interest or welfare warrants immediate  action" [40 C.F.R.
S171.11 (f)(5)(i)j*  Therefore, EPA will deny,  suspend, modify, or revoke a
certification only in response to serious violations  or against persons
with a history of noncompliance.  The Agency may  take any of these actions
if it determines that an applicant for or holder  of a certification has:

     •  Been convicted under Section 14(b) of FIFRA;

     •  Been subject to a final order imposing  a  civil  penalty under
        Section 14(a);

     •  Misused a pesticide;

     •  Made available for use, or used, a registered pesticide classified
        for restricted use. other than in accordance with  Section 3(d);

     •  Refused to keep and maintain records required by  40 C.F.R. Part
        171;

     •  Made false or fraudulent records, invoices, or  reports;

     •  Failed to comply with any limitations or  restrictions  on or in  a
        previously issued certificate; or

     •  Violated any other provision of  FIFRA or  Its  regulations.


Denial/ Revocations

The denial or revocation of a certification not only  deprives  an applicator
of the authority to apply restricted use pesticides but also,  as compared
to suspension of a certification, forces the applicator to  take  additional
steps to acquire or re-acquire certification.   In addition,  the  Agency  will
not consider an application to acquire or re-acquire  certification for  a
period of not less than six months following denial or revocation.   Thus
EPA will deny or revoke a certification only where a  violation has resulted

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 Chapter Five	  Level of Action Policy
 in a fatality or created  an  imminent  danger  of a fatality,  where the viola-
 tor's certification has been suspended  as  a  result  of  a previous violation,
 or where a person has made fraudulent records  or reports.


 Suspensions

 When considering invoking the less severe  alternative  of suspending a cer-
 tification, EPA personnel must determine whether it is appropriate to pur-
 sue a suspension and for  how long such  suspension should be in effect.
 These determinations will depend upon the  gravity of the violation in
 question.

 Suspension (Misuse Violation).  In suspending  a certification  due to an
 Incident of misuse, EPA will refer to criteria for  assessing the gravity of
 a use violation (see Exhibit 5-2).  The gravity of  a use violation is a
 function of:

      •  The risk of harm  posed to human health and  the environment by the
         violation; and

      •  The degree of misconduct exhibited by  the violator.

 The Agency will assign weightings, based on  the gravity criteria, for each
 use violation relative to the pesticide involved, the  harm  to  human health
 and/or to the environment, the history of  noncompliance, and the culpabil-
 ity of the violator.  (For purposes of this  section of the  manual, EPA will
 not distinguish between commercial and private applicators. Consideration
 of applicator status is Inherent in the policy in that suspensions have a
 more substantial Impact on commercial applicators,  affecting their primary
 business activity.)  The  Agency will  use the gravity value  thus obtained to
 decide whether and for how long to suspend a certification, in .accordance
-with the following table:
      Total Gravity Value        Enforcement Remedy

      4 or below                 Mo action or Notice of Warning
      5 to 8                     Suspension of up to 2 months
      9 to 12                    Suspension of .between 2 And 4 months
     • 13 ;or rmtoove            :  ,-.-• Suspension t»f JNtaain 4 *nd 6 wmtbe
 To  determine whether the term of a suspension should be at the higher or
 lower end of the given ranges, EPA will consider any gravity-related fac-
 tors not accounted for in the gravity criteria.  In addition, EPA will con-
 sider the degree to uM^h frh* anajvanflfon jrfU )t*m» >.-,mn -
      cm tfae «ppllca£or* •:<*$&*%?+**?*+ -i*™******* •-^••-••Inl'Mitly- -gf f rettti IT a
 suspension, such as those who apply restricted use pesticides Infrequently,
 should receive longer suspensions than applicators whose day-to-day
 FIFRA Compliance/Baxoreeaent             5-7           Guidance Mp**"a1 1983

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Chapter Five	            	Level of Action Policy
business activities would be  severely  disrupted  by the loss of their
certifications.

Suspensions should generally  be pursued  against  individual applicators  in
lieu of a  Section 14(a) civil administrative  penalty.   This, however, does
not preclude EPA from issuing both a suspension  as well as issuing a
warning letter or from assessing  a civil penalty against the employer of
the applicator In addition to suspending the  certification of the applica-
tor.

Suspension (Recordkeeping Violation).  EPA may also suspend certifications
of commercial applicators who violate  restricted use pesticides record-
keeping requirements [see 40  C.F.R. f171.11(c)(7); 40  C.F.R. $171.ll(f)(1)
(111)].  These violations do  not  lend  themselves to analysis utilizing
gravity of harm criteria.  Consequently,  EPA  will suspend the certifica-
tions of persons who fall to  maintain  restricted use pesticides records
based solely on gravity of misconduct  considerations.   The Agency will  •
assess suspensions of up to two months for the second  Independent violation
resulting from the failure to maintain restricted use  pesticides records.
For each additional violation, two months  may be added to the term of the
suspension up to a limit of six months.   In cases where the violation
Involved keeping fraudulent records (i.e., where the violator Intentionally
concealed or misrepresented the true circumstances and the extent of the
use of restricted use pesticides), EPA may revoke the  violator's certifica-
tion in response to the initial infraction.

If EPA decides to suspend certification,  It must notify the applicator  of
the time period during which  the  suspension will be In effect.   In order
for the suspension to function as a deterrent, the suspension should take
effect during the time when the applicator is  most likely to be applying
restricted use pesticides. •
Recall Requests	


No explicit authority exists in FIFRA for the recall of products.  The
effectiveness of a recall action, therefore, is contingent on  the
cooperation of the Involved company.

Recalls should be Initiated by EPA in all cases where available Information
Indicates that the product is either potentially hazardous when used as
directed or Ineffective for the purposes claimed.  The Agency  should
consider a recall of a product when, among other things, its use as
directed is likely to result in:

     •  Injury to the user or handler of the product;

     •  Injury to domestic animals, fish, wildlife, or plant life;
FIFRA Compliance/Enforcement:             5^8           Guidance Manual 1983

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 Chapter Five	Level of Action Policy
      •   Physical or economic injury because of ineffectiveness or due to
         the presence of actionable residues; or

      •   Identifiable adverse effect on the environment.

EPA personnel must view a request for recall as a serious and extraordinary
matter  and must make a request for recall of a product only In those cases
where the evidence clearly supports such action.  The initial decision that
a  product should be withdrawn from the market will be based on Information
In the  sample file including laboratory analyses, staff evaluations and
opinions, and such other information as may be available and relevant.  All
Information supporting a recall decision.must be included in the official
file.
Formal  and  Informal Recalls
There  are  two  types of recalls—formal and informal.  Formal recalls are
used for more  serious problems when it is essential that EPA regional per-
sonnel follow  up the recall with a visit to the company.  Formal recall
Involves "EPA monitoring, ^detailed reporting by the company Involved, and
notification to State officials.  This type of recall is normally accom-
panied by  another enforcement action, generally a civil penalty.

The Agency uses informal recalls in cases where a recall is necessary but
the level  of potential hazard is not great or when it is unlikely that sig-
nificant amounts of the defective product remain in the marketplace.  An
Informal recall is conducted entirely by the company Involved with no moni-
toring by  EPA  or State officials.


Level  of Recall Determination
    level of recall  Is  the point In the distribution chain from which the
product Is  to  be  recalled.  The determination of that point is based on the
potential hazard, use pattern,  and distribution pattern of the product.
The following  recall levels should be  considered:

     •  Wholesale or First Point of Distribution.   This will normally
        include all  Informal  recalls and those formal recalls In which the
        product distribution is limited and  consequently the .potential
               .low.
     •  Retail Level.   This will  be  the  normal  level  for most formal  re-
        calls.

     •  User Level.  This  level will be  requested  only In cases  in which
        there Is a known serious  hazard  to human health or the environment.
F1AA liovpliance/Enforceaent              5=9         '   Guidance Manual  1983

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 Chapter  Five   	            	Level of Action Policy
 Scope of  the  Recall

 EPA must  also consider the  scope of the recall (i.e., the amount of the
 product that  the  recall will  cover).   In the case of labeling violations,
 the recall should include all of the  product bearing the unacceptable
 labeling.  For chemical violations, the recall should include all of the
 product bearing the  same batch code(s) as the sample(s) found In viola-
 tion.  If the product  is uncoded,  EPA will determine the scope of the
 recall after  contacting the responsible company.   After reviewing the
 firm's manufacturing and shipping  records, EPA personnel should be able to
 determine a range of manufacturing dates to Include In the recall.

 The recall of a defective product  by  the manufacturer or distributor is the
 most effective and efficient  means of removing such a product from the mar-
 ket.  However,  since it Is  strictly voluntary, the success of the recall
 program depends on the industry's  knowledge that:

     •  EPA will  make  a recall request only in those cases where there is a
        likelihood of  physical or  economic Injury from the use of a product
        according to label  directions;

     •  The Agency will use all legal means available to it to support or
        supplement any recall request,  including  stop sale, use, or removal
        orders, seizures, and civil penalties; and

     •  State  officials  will  cooperate  with the Agency in the removal of
        such  products.
Stop Sale, Use, or Removal Orders	


A stop sale, use, or removal order  (SSURO) should be Issued by EPA if the
violation is of an ongoing nature and threatens  to cause serious or
widespread harm.  This remedy Is not designed  to prevent future violations,
but rather is intended to limit the amount of  harm that might result from a
violation.  In order to preserve the hearing rights of the recipient of an
SSURO, EPA should supplement the order with a  civil penalty assessment.

An SSURO Is among the most expedient and effective remedies available to
EPA In its efforts to prevent Illegal sale, distribution, and use of pesti-
cides.  Its advantages over other actions (such  as seizures) are that:

     •  It may be Issued without prior adjudication of the violatlve char-
        acter of the product (i.e., EPA may issue an SSURO simply when it
        has reason to believe that  the product is in violation of the Act);

     •  It is easier to prepare and issue than a seizure;
FIFRA CoKTl"1 *•"'•*/1tnfnr''*~"nt'             *-ln          Guidance

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 Chapter  Five	Level of Action Policy
     •   It  can be written so as to include future amounts of the product
         that  may come into the custody of the person on whom the SSURO is
         served;  and

     •   It  can be easily adapted to particular circumstances.


Criteria for  Use

The language  of  Section 13(a)  confers  broad authority upon EPA to issue
SSDROs.  The  Agency may issue  an SSURO when any one of three situations
exists:

     •   If, upon inspection or testing, EPA believes a product is In viola-
         tion  of  the Act;

     •   If  EPA believes that a product has been or is Intended to be dis-
         tributed or sold in violation  of the Act; or

     •   If  EPA has cancelled or suspended the registration of a product.

An SSURO is ordinarily Issued  by EPA without prior notice to the person
served.  Because an order is Issued without notice, the actual or potential
danger to human  health or the  environment posed by the vlolatlve product or
situation must be both serious and imminent*  In addition, the danger must
require  such  urgent relief that there  is no time to seek other remedies or
that other  administrative remedies would be inappropriate.  Accordingly,
EPA officials  must observe stringent guidelines In determining whether
issuance of an SSURO  is appropriate, as outlined below.

Mandatory Issuance of an SSURO.  The Agency must issue an SSURO against
persons who own,  control,  or have  custody of pesticides In the following
categories:

     •   Pesticides whose registrations  have been cancelled or suspended by
         EPA,  except cases  In which the  Agency has permitted the use  of
        existing stocks,  or where  continued marketing presents no human
        health or environmental hazard;

     •   Pesticides for which there is  reason to believe present a potential
        hazard to man or the environment because:

        -They  are not registered,  or  are so grossly overf emulated or
           adulterated, as to  present a serious health hazard,  or
         -  They  are packaged in improper or damaged containers, or are so
           Inadequately labeled, as  to  Bake safe or effective use unlikely
           or  impossible;
FIFIA Gmpllance/Enlorceaent             5-11          guidance Manual 1983

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 Chapter Five	   	Level of Action Policy
     •  Pesticides  or devices with labeling that  is materially misleading
        or fraudulent and,  if observed  by  a user, is likely to cause a
        life-endangering health  hazard  or  serious adverse environmental
        condition.   (A pesticide lacking a restricted use label is an
        especially  serious  labeling violation.)   This provision includes
        labeling for products that:

        -  Are ineffective  for the purposes claimed,
        -  Are so chemically deficient  as  to affect deleteriously the pro-
           duct's efficacy, as determined  by laboratory test results, or
        -  Bear false or misleading safety claims;

     •  Pesticides  or hazardous  devices* that are in violation of the Act
        and are the subject of a voluntary recall,  but which the respon-
        sible party refuses to remove,  is  recalcitrant in removing,  or is
        unable to remove from channels  of  trade;  and

     •  Pesticides  or hazardous  devices that  are  in violation of the Act
        and for which a civil penalty has  been Issued but which have not
        been brought into compliance.

Discretionary Issuance of an SSURO.  EPA may exercise its discretion in
Issuing an SSURO in cases where  a product  either  is in violation of  the Act
or is Intended to be distributed  or  sold in violation of  the Act, and the
gravity of the violation is less  than that  required for issuance of  a
mandatory SSURO.  In addition to  an  analysis  of the relative severity of
the violation (or lack thereof),  the following factors should be
considered:

     •  Whether the violation is  another in a series  of violations by the
        producer or distributor.   In cases  of recidivism,  of uncorrected
        violations  previously brought to the  individual's  attention,  or of
        repeated negligent  conduct,  an  SSURO may  be appropriate where other
        enforcement remedies have  failed to bring about corrective action
        or where it is deemed necessary to  prevent  continued marketing of
        the violative product;

     •  Whether the violation is  easily corrected*   If it  appears that the
        individual  is cooperative  and can  easily  remedy the  violation, an
        SSURO may be unnecessary;  and
* A hazardous device is one presenting a direct threat to human health or
  the environment by its use (e.g., a water treatment device whose labeling
  makes false, misleading, or fraudulent claims to purify raw well water or
  other untreated water supplies).  For nonhazardous devices (e.g., an
  electromagnetic rodent repelling device) that are misbranded, Agency
  policy is to complete civil penalty proceedings before issuing an SSURO.
  See December 19, 1979 Memorandum:  "Enforcement Actions Concerning
  Nonhazardous Pesticide Devices."
FIFRA Compliance/Enforcement             5-12          Guidance Manual 1983

-------
 Chapter  Five          	 Level of Action Policy
      •   Who has custody of the product.  An SSURO may be more appropriate,
         and a violation more Immediately cured, If the vlolatlve product IB
         found at the producer level rather than at the retail level.

In all  other cases,  EPA should consider an alternative enforcement remedy
available under FLFRA.
Use of  SSURO for  Minor Violations

While £PA will  usually reserve the use of an SSDRO to relatively serious
violations,  the need to Issue an SSURO may arise in certain cases Involving
minor violations.  For example, in the face of continued and repeated minor
violations,  or  when several minor violations appear together on a label,
EPA may decide  to issue an SSURO to ensure that the product will be
distributed  only  in compliance with the Act.


Alternative  Approaches

Even in cases"where the existence of a serious violation would justify the
issuance of  an  SSURO,  the Agency may consider the use of alternative
approaches to achieve  compliance.  For example, certain pesticide labeling
violations can  be rectified through a voluntary recall by the manufacturer,
and this may be the most expeditious way to prevent any harm to human
health  or the environment.   Thus, in certain cases that could legitimately
call for the Issuance  of an SSURO,  particularly those concerned with
labeling violations, EPA might first consider contacting the appropriate
responsible  party and  negotiating a voluntary recall.
Civil
A civil penalty, as authorized by  Section  I4(a) of  FIFEA,  is  the remedy of
choice for most violations.  A civil penalty  should be  proposed where the
violation presents (a real but not an extreme and unreasonable) risk to
humans or the environment; is likely to be an isolated  occurrence; was
apparently committed as a result of ordinary  negligence, Inadvertence, or
        Involves a first offense under  the Act by any registrant, commer-
        cial applicator, "for hire" applicator, wholesaler, dealer,  re-
        taller, or other distributor (no prior warning is required by  FIFEA
        for violators in this category); or

        Involves a private applicator or other person, other £han any  party
        ^specified Ja'titf JClxst•;,*a*!^fgM*rj••••*•* ***Xi****Tfnd -a jrlor TOnr^rg
        or ^clt«tlt«"
-------
 Chapter Five	Level of Action Policy
 Injunctions
 Section  16(c) of FIFRA gives  EPA the  authority to initiate injunctive
 actions  before district courts.*  Because  an injunction is an extraordinary
 form of  relief, the Agency's  arguments  must be clear and compelling.  In
 initiating a permanent injunction action,  EPA must indicate to the court
 that:

     •   The Agency's administrative or  other judicial enforcement remedies
         would be inadequate either at restraining the violation or at pre-
         venting unreasonable  risk to  human health or the environment;

     •   The Agency has, in fact,  already diligently exercised all appro-
         priate administrative remedies  (such as  SSUROs and civil penal-
         ties), yet the violation continues unabated;  and

     •   Irreparable injury, loss,  or  damage will result if relief is not
         granted.

 In the case of a preliminary Injunction or temporary restraining order, the
Agency must additionally demonstrate  that:

     •   immediate and irreparable injury,  loss,  or damage will result if
         relief is not granted; and

     •   There is a likelihood of  success at trial, based on facts before
         the court.

Under FIFRA, there are a number  of specific circumstances that may justify
injunctive relief.  These include  but are  not limited to:

     •   The violation of a Section 6  suspension  order;

     •   The violation of an SSURO where a  civil  penalty or criminal prose-
         cution would not provide  a timely  or effective remedy to deter fur-
         ther violations;

     •   There is continued production,  shipment,  sale, or use of an unreg-
         istered pesticide after  the Agency has taken  civil or criminal
         action; and
   These actions may consist of permanent injunctions, preliminary injunc-
   tions, or temporary restraining orders.  These types of injunctions are
   discussed in more detail in Section 4 of Chapter Eight.
FIFEA Compliance/Enforcement             3-14          Guidance Manual 1983

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 Chapter Five	    	      Level of Action Policy
         The Agency has exercised an enforcement  remedy and a person con-
         tinues to make available for use a restricted  use  pesticide other
         than in accordance with FIFRA  Section  3(d),  or continues to use a
         pesticide in a manner inconsistent with  its  labeling or In a manner
         contrary to an experimental use permit.
 Seizures
 Section 13(b) of FIFRA gives EPA the authority to initiate  in rem condemna-
 tion proceedings in district court.  Once a court grants  the  Agency's
 request for authority to conduct a seizure, FIFRA Section 9(b) authorizes
 duly designated Agency employees to obtain and execute warrants for the
 purpose of seizing any pesticide or device that is in violation of the Act.

 Since seizures are judicial actions directed against violatlve products
 rather than ..against • Relieve ±hat a person, if issued 
-------
Chapter Five	Level of Action Policy
Criminal  Proceedings
Section  14(b) of FIFRA provides EPA with  the  authority to proceed with
criminal sanctions against violators of the Act,  subject to the following
distinctions:

     •  A registrant, commercial applicator,  wholesaler, dealer, retailer,
        or other distributor who knowingly violates  the Act is subject,
        upon conviction, to a fine of not more  than  $25,000, or Imprison-
        ment for not more than one year, or both.

     •  A private applicator or other person  not  Included above who know-
        ingly violates the Act Is subject, upon conviction, to a fine of
        not more than $1,000, or Imprisonment for not  more than 30 days, or
        both.

The Agency may initiate criminal proceedings  In every  case In which EPA can
meet the stringent requirements of evidence and proof  leading to a convic-
tion.  However, Agency policy, as well as pragmatic  resource considera-
tions, argues against the use of criminal sanctions  In any but the most
serious Instances of environmental misconduct,  as determined by the nature
of the violation, the history of compliance on  the part of the responsible
person, or the seriousness of the environmental consequences.


Considerations
There are a number of specific factors that the Agency must  carefully con-
sider before proceeding with a criminal prosecution.  (Chapter  Nine,
"Judicial Enforcement:  Criminal Actions," addresses these considerations
in much greater detail.)

Knowledge.  The Agency must determine that the violator In question know-
ingly violated the statute.  That Is, there must be evidence of intent in
the commission of the vlolative act, rather than it merely being the  result
of accident or mistake.

Seriousness.  Criminal actions should be considered for the most serious
types of environmental misconduct.  This consideration will be  judged by
reviewing the extent of environmental harm or human health hazard that
resulted from, or was threatened by, the prohibited conduct.  Factors ouch
as the duration of the -conduct and the toxic!ty of the pollutants are
considered.  Also of significance In assessing the seriousness  of the
conduct Is the Impact—real or potential—upon EPA's regulatory function.

Deterrence.  The Agency must consider the Importance of and need for  deter-
rence of criminal conduct, either on the part of a specific person, or on
the part of the larger community.  In the case of a serious and willful
violation, the Interests of deterrence may well best be served  by the
Imposition of criminal sanctions.
      Compliance/Enforcement             5-16          Guidance Manual 1983

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 Chapter Five      	          _   	Level of Action Policy
 Compliance History.  The compliance history of the person who Is the sub-
 ject of possible criminal proceedings will enter Into the Agency's deliber-
 ations.  While a history of noncompllance is not requisite for pursuing
 criminal sanctions, certainly criminal prosecution becomes more appropriate
 when a history of noncompllance exists.

 Simultaneous Actions.  The Agency may consider whether there is a need for
 criminal enforcement proceedings contemporaneous with a civil or adminis-
 trative enforcement action, or whether one type of action alone will serve
 the situation in question.  While simultaneous proceedings are permissible,
 and there may be very compelling reasons for pursuing both, the legal and
 practical difficulties inherent in so doing, argue-against such an approach
 except in the most extraordinary circumstances.


 Use of Criminal Proceedings

 The Agency has identified a number of specific situations that may be
 considered of such a serious nature that criminal prosecution is
 particularly appropriate.  To J.ist these situations,  however, should not be
 •viewed .as precluding criminal  prosecution in circumstances not Included
 below:
   *
      •  Failure to report information on the unreasonable adverse effects
         of a registered pesticide;

      •  Falsification of records;

      •  Violation of an order suspending or  cancelling a product
         registration;

      •  Violation of an SSURO;

     <•  Unlawful uses of pesticides;  and

      •  Illegal distribution of unregistered pesticides.
FIFSA Ompllance/Baforceaent             5-17          Guidance Manual 1983

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 Chapter  Five
               Efficacy Standards  and Level of Action Guidance
                    for Disinfectants and Rodentlcldes
  Efficacy standards have  been developed  and are being utilized by the
  Agency for hospital or medical use disinfectant products and rodenti-
  cldes.  The efficacy  standards and level  of action guidance for these
  two types of  pectlcldes  are summarized  below.   However, for the com-
  plete disinfectants laboratory testing  procedures and level of action
  guidance, refer  to December 17,  1980 Memorandum:   "Regulation of Public
  Health Belated Disinfectant Products."  Additionally, for both disin-
  fectants and  rodentlcides, consult the  civil penalty matrix in Appendix
  6 for the appropriate civil penalty calculations.
                               Disinfectants
  Only hospital or medical use products  that make  claims for Salmonella
  choleraesius, Staphylococcus aureus, or Pseudomonus  aeruglnosa* are
  tested.
  Level I Testing

  In Level I testing, 60 carriers must be tested  against  each of the
  above organisms with each of three samples, representing three
  different batches.  This amounts to 180 carriers  per  sample;  a total
  of 540 carriers.

     •  Disinfectant Sample(s)

        Performance Standard;  A sample is determined to  fail efficacy
        testing if organisms on 2 or more of the  60 carriers  are not
        destroyed.

        Level of Action;  For each sample that fails the  above  standard,
        an SSURO is issued on the batch from which  the  sample was
        collected and a civil penalty is Issued for failure of  the
        batch to meet the efficacy requirements.
     Failure of a product to destroy Pseudomonus aeruglnosa is considered
     equal to failure of a product to destroy Staphylococcus aureus or
     Salmonella choleraesius.
FURA Ompllance/Enforceaent        5-18               Guidance Manual 1983

-------
 Chapter Five      ^	      	Exhibit 5-1
      •   Disinfectant Product(s)

         Performance Standard;   A product provisionally fails efficacy
         testing if two or more of the three samples fall to destroy any
         test  organism.

         Level of Action;  Level II testing is Initiated for each product
         that  fails the above standard.
  Level II Testing

  If a product  fails Level I testing, five additional samples represen-
  ting five  different batches are collected for testing at Level II.
  Sixty carriers  are tested for each organism that the product falls to
  destroy in Level I.

     •  Disinfectant Sample(s)

        yerfDTmance 'Standard:  A sample is determined to fall efficacy
        requirements If organisms on 2 or more of the 60 carriers are
        not  destroyed*

        Level of  Action;  For each sample that fails the above standards,
        an SSURO  is issued on the batch from which the sample was col-
        lected, and a civil penalty is issued for failure of the batch to
        meet the  efficacy requirements.

     •  Disinfectant Product(s)

        Performance .Standards  A product la determined to fall efficacy
     .  .testing .If .three .or acre of the five «ampl«s fall to destroy any
        organism.*

        Level of  Action;  Initiation of cancellation proceedings.
                                 Bodentlcldeg
  Both single dose  (acute)  and multiple  dose rodentlcldes that sake
  claims for commensal  rodents are  tested  for efficacy.
     ljev«l TI product failures are "based  on  the  upper  bounds of the 95
     percent confidence level.   Consequently, a  sample must fail 5 out of
     60 carriers  (not 2 out  of 60 as  In Level I  tests) to count as a
     failure.
FIFRA Coapllance/Enforceaent         5-19                Guidance MMMI  1983

-------
 Chapter  Five                 	__	   Exhibit 5-1
      •  Acute  or  Single Dose

         Performance  Standard:   The minimum standard is 90 percent rodent
         mortality after eight  days of testing for the product to be
         effective in commensal rodent control.

         Level  of  Action;   A civil penalty is issued for failure of the
         batch  to  meet the  above efficacy requirements.

      •  Multiple  Dose

         — Cereal or water baits

         Performance  Standard;   The minimum standard is 33 1/3 percent
         bait acceptance and 90 percent mortality in order for the product
         to be  considered effective In a commensal rodent population.

         Level  of  Action;   A civil penalty is issued for failure of the
         batch  to  meet the  above efficacy requirements.

         — Paraffin  blocks

         Performance  Standard;   The minimum standard is 25 percent bait
         acceptance and  80 percent mortality in order for the product to
         be considered effective in a  commensal rodent population.

         Level  of  Action;  A civil penalty is Issued for failure of the
         batch  to  meet the above efficacy requirements.
FIFRA Compliance Enforcement           5-20            Guidance Manual  1983

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Chapter  Five
                                       Exhibit 5-2
            Criteria for Determining the Gravity of a Use Violation
                   for Purposes of a Certification Action
       Violation
Weighting
Activity
  GRAVITY  OF  HARM

     Pesticide
     Harm to Human
     Health
     Environmental
     Harm
                                   • :J
             -Toxicity—Category  I pesticides,
             restricted use  pesticides,  or
             pesticides that are associated
             with chronic health effects
             (mutagenlcity,  oncogen!city,
             teratogenlclty, etc.)
                                        Toxicity—Categories II through
                                        IV, no Jmown chronic effects
             Serious or widespread actual harm
             to human health
                                        Serious or widespread potential
                                        harm to human health
                                        Minor potential or actual harm to
                                        Yrrrman K»a1 »h
                                        widespread
             Substantial or widespread actual
             harm to the environment (e.g.,
             crops, water, livestock, wildlife,
                         or -other sensitive
                          )
                                        Substantial or widespread
                                        potential  harm to the environment
                                            to
                                             uvli uument ,  neither wide-
                                        spread  nor  substantial
v\ffA Compliance/Bnfor
          5-21
Guidance
                   1983

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 Chapter  Five
                                       Exhibit  5-2
        Violation
Weighting
Activity
   GRAVITY OF MISCONDUCT

      Noncompliance
      History
      Culpability
                               2


                               0
                               2


                               0
             More than one prior violation of
             FIFEA by the applicator
             One prior violation
             No prior violations
             Knowing or willful violation
             Violation resulting from negligence
             Violation was neither knowing nor
             willful and did not result from
             negligence; good faith efforts
             made to comply with the law
FIFRA Compliance/Enforcement
          5-22
Guidance
                   1983

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Chapter Six

Administrative  Enforcement  Actions:
Notices of Violation  and
Administrative  Orders
Chapter Contents	Page


1  Introduction                                           6-1

2  Administrative Enforcement  Procedures                     6-3

   Advertising Letters                                     6-3
   Notices of Detention                                    6-4
   Notices of Warning                                      6-4
   Terminations of Establishment Registrations                6-5
   Denials, Suspensions, Modifications, or
     Revocations of Applicator Certifications                 6-6
   Recall Requests                                        6-8
   Stop Sale, Use, or Removal  Orders                         6-10
   Exhibit 6-1:  Model Advertising Letter                    6-14
   Exhibit 6-2:  Model Notice  of Detention and Hearing         6-15
   Exhibit 6-3:  Model Release Notice                        6-16
   Exhibit 6-4:  Model Notice  of Refusal of Admission         6-17
   Exhibit 6-5:  Model Notice  of Warning                     6-18
   Exhibit 6-6:  Model Notice  of Intent To Terminate
               Establishment Registration                  6-19
   Exhibit 6-7:  Model Notice  of Termination of
               Establishment Registration                  6-20
   Exhibit 6-8:  Proposal for  Recall Form                    6-21
   Exhibit 6-9:  Model Formal  Recall Request In
               Connection with Suspension or
               Cancellation                               6-22
   Exhibit 6-10: Model Formal  Recall Request in
               Connection with Sample Collections           6-23
   Exhibit 6-11: Model Informal Recall Request                6-24
   Exhibit 6-12: Model Stop Sale, Use, or Removal Order        6-25
   Exhibit 6-13: Model Termination of Stop Sale, Use or
               Removal Order                             6-26
'IFRA Compliance/Enforcement            6-1          gaf.da"** Manual

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 Chapter Six	  Contents
FIFBA umpllance/Enforcement        6-ii               Guidance M"""»T 1983

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Chapter Six
1     Introduction
 This  chapter outlines the specific procedures that EPA should follow In
 Initiating and processing administrative enforcement actions, once the
 Agency  has determined that an administrative enforcement response Is appro-
 priate  for a detected violation.  These actions Include the following:

      •  Advertising letters;

      •  Notices of detention under Section 17(c);

      •  Notices of warning under Sections 9(c)(3) and 14(a)(2);

      •  Terminations of establishment registrations under 40 C.F.R.  5167.3;

      •  Denials, suspensions, modifications, or revocations of applicator
        certifications under 40 C.F.R. Sl7l.ll;

      •  Recall requests; and

     •  Stop sale, use, or removal orders under Section 13(a).

One or more examples of each type of  action, In Its proper  format, appear
as exhibits at the end of this chapter.

Civil administrative penalties are not covered  In this  chapter.  However,
civil administrative penalty procedures  are  outlined  in detail in Chapter
Seven, "Administrative Enforcement Actions:   Civil Penalty  Proceedings."
Appendix 6, "Penalty Policies," also  contains useful  procedural information
for civil penalty actions.  In addition,  Chapter Five,  "Determination of
Appropriate Enforcement Response," discusses the criteria the Agency uses
in deciding when and what type of enforcement actions to issue.
FIFBA Compliance/Enforcement        6-1                Guidance Manual 1983

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Chapter Six
                                                                .Introduction
                                  6-2
                                                     Guidance Manual 1983

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Chapter Six
2    Administrative  Enforcement
       Procedures
Advertising Letters
An advertising letter Is a letter Issued by EPA as notice to a company that
collateral literature concerning a pesticide or device bears unaccepted
pesticide statements or pesticide or device claims.  Since FIFRA does not
contain a specific provision for advertising letters, it is not an
enforcement action In an official sense.  Bather, it  indicates Agency
concern regarding the statements or claims found in the advertising or
literature related to a product and encourages voluntary correction on the
part of the responsible party.  It does not imply any further enforcement
action, although the Agency may take further action if EPA subsequently
collects an official sample and finds  that the company has not taken
corrective steps.


Content Requirements

An advertising letter consists of three parts (see Exhibit 6-1):

     •  An identification of the collateral literature;

     •  An identification of the unaccepted statements (if related to a
        registered pesticide), the pesticide claims (if related to an
        unregistered pesticide), or the device claims (if related to a
        device); and

     •  A request to the recipient to  respond to EPA  with an indication of
        how the company will make changes or corrections in the literature,
        typically by deleting, qualifying, or justifying the statements or
        claims.


 Service

 The Agency should issue an advertising letter by certified mall, return
 receipt requested.
 FIFBA Cwpliance/Enforcement        S—J                Guidance bSsamal 1985

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 Chapter Six	        Administrative  Enforcement Procedures
 Notices of Detention
 Section 17 of FIFRA authorizes EPA to refuse admission of  a pesticide  or
 device being Imported into the United States if EPA determines  that  such
 product violates any provisions of the Act.  This refusal  is known as  a
 Notice of Detention and Hearing (see Exhibit 6-2)*
 Procedures
 When, on the basis of available Information or actual inspection,  the
 Agency determines that an Imported shipment should be detained, EPA should
 prepare and issue to the importer a Notice of Detention and Hearing.  The
 Agency should also send a copy of the notice to the District Director of
 Customs at the port of entry.  For this reason, the EPA Regional Offices
 should have on file the names and addresses of the District Directors, plus
 the customs compliance officers or commodity specialists who deal with EPA
 for each port of entry within the .Region's Jurisdiction*

 Release Notice.  If, through examination of the product or other means, EPA
 can determine that the product has been brought into compliance with FIFRA,
 EPA should issue a Release Notice (see Exhibit 6-3) to the importer with a
 copy to the District Director of Customs of the port of entry.

 Refusal of Admission.  If the product has not been brought into compliance
 with the Act, EPA should issue a Notice of Refusal of Admission (see
 Exhibit 6-4) to the Importer with a copy to the District Director of
 Customs at the port of entry.  The District Director will refuse entry of
 the product and will cause .destruction of the product if the Importer does
 not export it within 90 days from the date of such Ifotlce of ..Refusal of
 Release of Product Under Bond.  If the District Director of Customs has
 already released the product to the importer under bond, the District
 Director will take action to enforce the terms of the bond.  If the
 District Director finds it necessary to request forfeiture of an importer's
 bond  because the importer did not hold the shipment Intact as required, the
 District Director may ask EPA to determine the amount to be levied against
 the Importer's bond.  The tfitmry f^f™lit A*f»r^in* f*nm*+4+m y^tvy-.M-np fn
±he aMMsrlty of the yinlatAom and the ^aaMSPM «fay the product was not
-available for redelivery .
Notices  of Warning
Section  14(a>C2) of JglEA J«pilre» gPA .to t»c m wtit» of •warning in
response to the first civil offense  committed by private applicators or
other  persons not covered under Section 14(a)(l).  The Agency may also
issue  notices of warning under Section 9(c)(3) of FIFRA in response to
P1FRA Coapliance/EiLforceaent            6^4            Guidance Manual 1983

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Chapter Six	Administrative Enforcement  Procedures




first-time violations committed by any registrant, commercial  applicator,
wholesaler, dealer, retailer, or other distributor, "for-hire" applicator—
that is, those persons covered by Section 14(a)(l)—if, in EPA's  judgment,
justice will be served by employing that remedy rather than a  civil penalty
or other action.
Content Requirements

A notice of warning is a letter to the responsible  party and consists  of
three parts (see Exhibit 6-5):

     •  Identification of the violative product  or  action;

     •  Identification, citation, and explanation of the violation;  and

     •  A closing paragraph indicating the expected response from the
        recipient, If any.

If the Agency does not receive the requested  response from the recipient,
indicating what action that party has taken to correct the violation,  the
Agency will not initiate any further enforcement action.  However, EPA may
wish to schedule a follow-up Inspection to determine whether the violation
has been corrected.  If EPA finds, upon reinspection, that the responsible
party has not corrected the violation, the Agency should proceed with  a
civil penalty.


Service

The Agency should issue a notice of warning by certified mail, return
receipt requested.
Terminations of Establishment Registrations	


The regulations related  to  the  registration  of  pesticide-producing
establishments, at  40 C.F.R.  5167.3,  state that the registration of an
establishment will  remain In  effect  so long  as  the establishment continues
to submit  annual  pesticides reports.   If the establishment falls to submit
a report In any year, EPA may issue  either a notice of warning or a civil
penalty, based  on the provisions of  FIFRA Sections 7(c)(l) and
 12(a)(2)(L). A notice of warning Is the appropriate action for a newly
registered establishment that falls  to submit its initial pesticides
report.  The Agency should  initiate  a civil  penalty In response to the
failure  to file a pesticides  report  on the part of an establishment that
previously filed  at least one annual report  and is thus on notice as to its
continuing responsibility to  submit  annual reports.
                    corceaent            6-5

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Chapter  Six	    Af*»-tn-f«trative Enforcement Procedures
Procedures

If the establishment does not submit a report within 20 days after the date
of receipt  of  a  notice of warning or civil penalty, EPA should issue a
Notice of Intent to  Terminate Establishment Registration (see Exhibit
6-6).  This notice informs the establishment of the violation of failure to
report and  warns the establishment of Impending termination of registration
if EPA does not  receive the delinquent report In an additional 20 days.
The notice  also  reminds the establishment of the potential violation of
producing pesticides, active Ingredients, or devices in an unregistered
establishment.

Termination of Registration.  If the Agency does not receive the delinquent
report in the  20-day period following its issuance of a Notice of Intent to
Terminate Establishment Registration, EPA should then issue a Notice of
Termination of Establishment Registration (see Exhibit 6-7).  This notice
revokes  the registration, effective as of the date of Issuance, and
contains a  warning against producing pesticides, active ingredients, or
devices  in  an  unregistered establishment,, as veil as Instructions for
^frtMnyfrng T+*v*t***m**** of *••%****»**««.  The Agency should send the notice
"by certified mail, return receipt requested.  The Agency may proceed with
both the Notice  of Intent To Terminate Establishment Registration and the
Notice of Termination of Establishment Registration Independently of any
other action,  such as a civil penalty.

Reinstatement  of Registration.  It is Agency policy to reinstate terminated
establishment  registration, provided that the company submits all reports
due and  submits  a completed Application for Registration of Pesticide-
Producing Establishment (EPA Form 3540-8).  The Agency will issue the same
establishment  registration number to the re-registered establishment.  The
submission  of  delinquent reports and of an fj*r1'*'"'f"t'>" fnr..p*i-*M4*tim»nf
registration, ;3awBv«r, does not preclude the Agency -from proceeding with *
      penalty  action for failure to submit reports.
Denials,  Suspensions, Modifications, or Revocations of Applicator
Certifications	


aha.^gagn1«rt«Mv-«»-1^H^v-tox«^^                                        (40
C.T.TU Part 171)  authorize EPA to deny, suspend, modify, or revoke
federally Issued  applicator certifications If the certificate holder
violates  FIFRA  or Its regulations.  The regulations also specify the
procedures that EPA must follow in denying, suspending, modifying, or
revoking  a certification.
The Agency jiay suspend any fiarf :or:vll of.'M. - y*» * * t^t^y+^op jLavedifttel
                  £or «>Aevxiag /upon det«rn±nlTig that such action is
warranted  by "the public health, interest, or welfare" [40 C.F.R.
fl71.11(f)(5)(l)].  The Agency may deny issuance of a certificate, or
modify or  revoke an existing certificate, after providing opportunity for a
hearing .
FIFRA Compliance/Enforcement"            §=5         '	6uidanc«

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Chapter Six        	      A^«*"*strative Enforcement  Procedures
Content Requirements

Suspension.  If EPA decides to suspend a certification,  the  Agency must
notify the certificate holder of:

     •  The grounds for suspension;

     •  The time period during which the suspension will be  effective; and

     •  The Agency's intent to revoke or modify the certificate,  as
        appropriate.  A notice to revoke or modify may be issued  before  or
        at the same time as the notice to suspend.

Denial.  If the Agency decides to deny the issuance of a certificate to  an
applicant, or to modify or revoke a previously issued certificate, It must
notify the applicant or certificate holder of:

     •  The grounds for such action;

     •  The time period for which such action will be effective and whether
        the action will be permanent or  temporary;

     •  The conditions, if any, under which  the person may become certified
        or recertified; and

     •  Any additional conditions that EPA may Impose.


Hearings

At  the same time,  the Agency must also provide the affected person with the
opportunity to request a hearing prior to final Agency  action on its
proposed denial, revocation, or modification.  If the person requests such
a hearing, EPA must:

     •  Notify the person of the assertions  and facts upon which EPA has
        based Its decision;

     •  Provide the person opportunity to offer written statements,
        explanations, comments, and  arguments  relevant  to the proposed
        action;

      •  Provide  the  person such other procedural  opportunities as may be
         appropriate  to  ensure  a fair and impartial hearing; and

      •  Appoint  an EPA attorney,  who has no prior connection with the case
         at hand,  as  Presiding  Officer to conduct  the hearing.

 The Presiding Officer must promptly conduct a hearing.   He  or she must
 consider all  evidence,  explanations, comments, and arguments submitted by
 both EPA and  the affected person and render a decision and  order as soon as
 possible.   Such an order is a  final Agency decision, subject to judicial
 review under  FIFRA Section 16.
 PURA Compliance/Baf or cement            2F7            Guidance Manual 1SJB3

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 Chapter Six	Administrative Enforcement Procedures
 Considerations

 As noted above, a suspension, because of the extraordinary circumstances
 implicit in such an action, becomes effective Immediately, and there is no
 opportunity for review or appeal.  However, since a notice to suspend must
 include or be preceded by a notice to deny, modify, or revoke a
 certificate, and since a denial, modification, or revocation must include
 opportunity to request a hearing prior to final Agency action, the affected
 person retains the right to a hearing.
 Recall  Requests	


 A recall is a request from the Agency to the party responsible for a
.violative product to voluntarily withdraw that product from the
 marketplace.  Because FIFRA contains no explicit authority for recalls, the
 effectiveness of such an action is dependent on the cooperation of the
 Involved company.

 The Headquarters PTSCMS and the Registration Division of the Office of
 Pesticide Programs jointly will make the determination for a formal recall
 involving a product whose registration EPA has suspended or cancelled.  In
 all other cases, the Region in which a violative product was produced will
 make the decision to Initiate a recall and whether the recall should be
 formal  or informal.  A Region initiating a recall must consult with the
 Headquarters PTSCMS.  Consultation with the Registration Division is also
 required for all formal recalls.


 .Procedures
When consulting with PTSCMS, the initiating Region should forward a
Proposal for Recall Form (see Exhibit 6-8) to PTSCMS by telecopier, along
with adequate documentation by which to judge the recall decision.  If
PTSCMS agrees with a recall (along with the Registration Division, if
necessary), the Region would receive Initial notification of the decision
by telephone.  PTSCMS would then return the Proposal for Recall Form by
mall, signed by a PTSCMS official (and a Registration Division official, if
                                                               object .to
          to recall , *the form would be returned with the reasons for the
 objection noted in writing.

 The Agency should request a recall in the form of a letter to the
 responsible company.   It is Important that recall letters be as complete
 and Informative as possible.  Whenever possible, the letter should clearly
 express  the expected  level and scope .of -the xecall.
       Compliance/Enxorceaent            6-8            <_riHan«»» HI?""*"

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 Chapter Six	Administrative Enforcement Procedures
 Content Requirements

 A formal recall request  in connection with a suspension or cancellation
 should contain the  following (see Exhibit 6-9):

      •  The  reason  for recall;

      •  The  identity  of  the product  to be recalled;

      •  The  procedures to  be followed; and

      •  The  EPA personnel  who will supervise the action and who may be
         contacted by  the company in  regard to the recall.

 A formal recall request  for any other reason should include (see Exhibit
 6-10):

     .•  The  reason  for the recall, citing the violation;

      •  The  shipment  or  producer establishment involved;

      •  The  identity  of  the product  to be recalled, including batch codes
         if the recall involves  an ineffective or misformulated product;

     '•  The  procedures to  be followed; and

      •  The  EPA personnel  who will supervise the recall and whom the
         company may contact in  regard to  the recall.

 An Informal  recall  usually accompanies another enforcement action, such as
 a civil penalty or  a  stop  sale,  use,  or removal  order (SSURO).  The
 informal recall request  should  contain (see Exhibit 6-11):

      •  The  reason  for recall,  citing the violation; and

      •  The  identity  of  the product  to be recalled, including batch codes
         if the recall involves  an ineffective or misformulated product.

 The Headquarters PTSCMS  should prepare all formal recall letters Involving
 product registration  suspension  or cancellation.  The Regional Offices
 should prepare all  other types of recall  letters.  In either case, the
 Initiating office should mall the recall  letter  by certified mail, return
 receipt requested.  The  initiating office should also distribute copies of
 the recall letter to  the other Regional Offices  and to the Headquarters
 PTSCMS for their use  in  monitoring the recall.
FIFRA CbapUanee/Enforceaent            6-9            Guidance Manual  1983

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             Chapter Six	      Administrative Enforceaent Procedures
             An SSURO may apply prospectively to amounts of the named product that may
             come Into the person's ownership, control, or custody*
             Procedures
|             Service.  The Agency should serve a written or printed SSURO to the person
.             who owns, controls, or has custody of the vlolatlve product.  An authorized
I
            Agency employee should serve the original copy (i.e., deliver by hand) and
            acknowledge  the service by signing the order in the space provided and
1            entering his or her title and the time and date of service.  Where it Is
            highly Impractical to deliver an SSURO by hand, EPA may instead serve it by
            certified mall, return receipt requested.  The person served should
            acknowledge  receipt of the order by signing the order in the space
            provided, entering his or her title, and returning a copy to the person
            serving the  order (if it is served in person) or to the issuing EPA office
            (if  served by certified mall).  A failure or refusal on the part of the
            person served to acknowledge receipt does not Invalidate either the order
;            or its service, but the EPA official or .office .serving -the order should
                 ±n the  file «uch a failure or refusal.
             Marking.  Wherever practical, a sticker should be -placed on the material
             covered by the order to indicate to all persons coming in contact with the
             product that it is under such an order.  The sticker must be placed so as
             not  to obscure or destroy the product labeling when removed.  If the order
             is served in person, the EPA official making the service should post the
             sticker.  If the order Is served by mall, the order should instruct the
             person served to clearly identify to his or her employees the product that
             is under order.  The issuing EPA office may also wish to include with the
             order  a sticker for the receiving person to post with the product or an
             illustrative example of how the product covered by the order should be
            ^identified.
            Monitoring the SSURO

            As  long as an SSURO remains in effect, the issuing EPA office should
            monitor periodically the order to determine that its terms are being
            observed.   Similarly, EPA should check for compliance with the order before
            terminating it.   Documentation of such monitoring should be noted in the
            'official file.


            Disposing  of the Product

            Since  any  product under an SSURO cannot be disposed of In any manner
            contrary to the  terms of the order,  the Agency must determine the proper
            disposition for
                             I>11«hrrt fin wntf\ ame -tarsm. ;m«Mwr1*m of the following:
                 •   Obtaining product registration;
            FIFRA Ompllance/Enforceaent            6-11           Guidance Manual 1983

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 Chapter  Six	         Administrative Enforcement Procedures
      •   Reconditioning  by  relabeling,  reformulation,  and/or repackaging so
         as  to bring  into compliance with  FIFRA;

      •   Relabeling so as to remove from the  purview of  FIFRA;

      •   Designating  for institutional  uses that  do  not  constitute use
         violations;

      •   Detoxifying;

      •   Distributing for sale  and use  for lawfully  registered uses;

      •   Relabeling or repackaging for  export In  confonuance with Sections
         3,  17, and 19 of FIFRA;

      •   Obtaining for distribution and use a valid  experimental use permit;
         or

      •   Destroying.


Terminating the SSURO

When  EPA determines  that the responsible  party has  taken appropriate steps
to accomplish proper disposition, EPA  should record the method of
disposition and the amount of  the pesticide  or device involved and issue a
letter terminating the  SSURO (see Exhibit 6-13).  In  cases  of disposition
requiring movement of the  product under the  SSURO,  EPA  must first amend the
order In writing to allow  such movement.  Therefore,  EPA should terminate
an order only after completion of the  disposition.

If EPA terminates an SSURO on  the basis of the responsible  person's
attestations that the product  has been brought Into compliance with FIFRA
but without benefit of  an  actual Inspection  by the  Agency,  EPA should draft
the letter terminating  the order so that  such termination is conditional
upon the product being  In  compliance with the Act.  The Agency might
otherwise find Itself in a situation In which the SSURO Is  terminated
although, through mistake  or fraud, the product Is  still not In compliance
with FIFRA.
Violations of the SSURO

Any violation of an SSURO Is a violation of FIFRA  Section 12(a)(2)(I)  and
Is considered a very serious violation warranting  either  a civil  or
criminal penalty.  The Agency may proceed directly to a civil  or  criminal
penalty, as appropriate, if the violator is a "registrant,  commercial
applicator, wholesaler, dealer, retailer, or other distributor."   In those
instances in which a private applicator or other person not Included under
Section 14(a)(l) violates an SSURO, Sections 14(a)(2) or  14(b)(2) govern
the violation.  Since Section 14(a)(2) requires a written warning for
first-time offenders, EPA should consider exercising either a  Section
I4(b)(2) criminal prosecution for private applicators or  other persons
FIFRA GoBpliance/Enforceaent            6-12           Guidance Manual 1983

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Chapter Slat	Administrative Enforcement Procedures
covered by  Section  14(a)(2) who  violate  an SSURO,  or Issue a notice of
warning and, should the  violation  of  the SSURO continue,  proceed with a
civil penalty.   In  addition to taking a  civil  penalty or  criminal action In
response to the  violation of  an  SSURO, EPA should  also institute Section
13(b) seizure proceedings to  prevent  any continued violations of the
order*  Should both a  seizure and  a  Section 14 penalty be ineffective in
preventing violation of  an SSURO,  the Agency may seek injunctive relief
under Section 16(c).
      umpii«nce/isa±orce»ent            o-lj            Qufdff"r» M?tllMl  1983

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 Chapter  Six	Exhibit 6-1


                         Model Advertising Letter
    (Company name)
    (Address)
   Subject:
   Gentlemen:

   In connection with  the  enforcement of the Federal Insecticide,
   Fungicide,  and Rodenticide  Act,  as-amended,  7 U.S.C. 5136, the
   Environmental Protection  Agency  has obtained copies of (title or
   description of collateral literature).

   This literature makes statements regarding* the product, (name of
   product), such as (quote  improper or unacceptable statements or
   claims).  These statements  identify the product as a pesticide within
   the meaning of the  Act.   Refer to Section 3  of the Act, a copy of
   which is enclosed.  The use of these statements in connection with the
   distribution and sale of  the product would constitute a violation of
   the Act.  Therefore, you  should  delete  these statements or submit an
   application for the registration of the product.

   Please inform us of the action you will take in this matter.

                                     Sincerely yours,
                                     (Signature,  name,  and title)
   Enclosure
    Note:  This is a general example only and does  not  represent the
    only appropriate format.  Additional or different paragraphs may be
    Included as necessary to fully explain or describe  the  unaccepted
    statements or claims and the response that the  Agency expects from
    the responsible party.
FIFEA GDBpllance/Bnforceaent        6*14               Guidance Manual  1983

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Chapter  Six
                                     Exhibit 6-2
                   Model lotice of Detention and
   (Company name)
   (Address)
   Subjec t:   (Sample number)
   Gentlemen:

   In connection with the enforcement  of  the  Federal Insecticide,
   Fungicide,  and Rodentlcide  Act,  as  amended,  7  U.S.C.  §136,  the
   Environmental Protection Agency  has examined samples  or other evidence
   concerning  the shipment described below, and has  determined that said
   shipment is in violation of the  Act.  Tou  should  continue to hold the
   merchandise pending A final, decision as to whether it shall be  admit-
   ted or refused admission.

   Pursuant to Section 17(c) of the Act,  the  Agency  hereby affords you an
   opportunity to offer  such explanation  as you wish for the Agency's
   consideration.  Tou should  file  your answer, signed by you  or your
   attorney, with this office  within twenty (20)  days  after your receipt
   of this notice.   Should you desire  to  present  your views orally, in
   addition to filing a  written reply,  you should so advise us in  your
   answer in order that  we may set  a date for such presentation, which
   would be held in  this office.
   Sample No(s).

   Date of Importation

   Consignee

   Shipper/Manufacturer

   Entry No.
             -Product Uame(s)
Date
                                          Port of Entry

                                      produc£(*) ^failed to comply "with
the provisions of the Act in that (describe violation).  A copy of the
Act is enclosed for your reference.

                                    Sincerely yours,
                                              ure, name, and title)
   Enclosure
FIFBA Ompllance/Enforceaent
         6-15
                                                    Guidance Mm*"n1 1983

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Chapter  Six	Exhibit 6-3


                           Model  Release Bo tice
   (Company name)
   (Address!  """""""
   Subject:  (Sample number)


   Gentlemen:

   In connection with the enforcement of  the  Federal Insecticide,
   Fungicide, and Rodenticide Act, as amended,  7  U.S.C.  $136, the
   Environmental Protection Agency has completed  its consideration of the
   following shipment.  Based on examination  of samples  or other evidence,
   the Agency concludes that, pursuant to Section 17(c)  of the Act, you
   need not further detain the merchandise.

   Sample No(s).                        Product Name(s)

   Date of Importation

   Consignee

   Shipper/Manufacturer

   Entry No.               Date               Port of Entry

   This notice does not constitute assurance  that the merchandise involved
   complies with all provisions of the Act and  in no way precludes fur-
   ther action should the Agency determine that the  merchandise is viola-
   tive.

                                      Sincerely yours,
                                      .(Signature, name,  and title)
FXFBA Compliance/Enforcement        6-16               Guidance Manual  1983

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Chapter  Six	Exhibit 6-4


                    Model Botlce of Refusal of Admission
   (Company name)
   (Address)
   Subject:  (Sample number)


   Gentlemen:

   In connection with  the  enforcement  of the  Federal Insecticide,
   Fungicide,  and  Rodenticlde  Act,  as  amended, 7 U.S.C. $136, the
   Environmental Protection Agency  has examined samples or other evidence
   with respect to the following  shipment and has granted to you an
   opportunity for a hearing.

   Sample No (s).                         Product Name(s)

   Date of Importation

   Consignee

   Shipper/Manufacturer

   Entry No.                Date               Port of Entry

   It appears  that the product(s) is(are)  not in compliance with the Act
   and is(are) subject to  refusal of admission due to the following


                            (Described violations)

   The Agency  hereby notifies you that  it  refused admission of the
   merchandise.  Tou must  export this merchandise,  under supervision of
   the Customs Service, within ninety (90) days  from the date of this
   notice or within such additional time as the  District Director of
   Customs specifies.   Failure to do so may result  in either the jdestruc-
   ;tion of ^nev?aercaandi»e «• authorized by ±he iAct,  or,  if  the  shipment
   iia« *eeu Teleased "to you under bond, in any action necessary  to  enforce
   the terms of said bond.

                                    Sincerely yours,
                                                          :titlc)
F37RA CbBpliance/Boforcevent        6-17                Guidance Manual  1983

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 Chapter  Six	Exhibit 6-5


                          Model Notice of Warning
   (Company name)
   (Address)
   SubJect:  (Sample number)

   Gentlemen:

   In connection with the enforcement of  the Federal Insecticide,
   Fungicide, and Rodentlcide Act,  as amended,  7 U.S.C. $136, the
   Environmental Protection Agency  has  under consideration a sample of
   (name of product), which the Agency  obtained on (date of inspection).
   This product had been released for shipment  by your producing
   establishment in (city and state)*

   The product did not comply with  the  provisions of the Act in that
   (describe violations).

   You should make all necessary corrections to assure yourself that any
   further marketing of this product is in full compliance with the
   provisions of the Act.  The Agency will Include in the file regarding
   this matter any additional Information that  you wish to submit.

                                        Sincerely yours,
                                        (Signature,  name,  and title)
    Note:  This is a general example only and does not  represent  the  only
    appropriate format.  Additional or different paragraphs may be  include
    as necessary to fully explain or describe violations  and  the  response
    that the Agency expects from the responsible party.
FIFXA. Compliance Enforcement        6-18               Guidance Manual  1983

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Chapter Six	            Exhibit 6-6


                    Model Hotlce of  Intent to Terminate
                         Establishment Begistratlon
   (Company name)
   (Address)
   .Subject:  (Establishment registration: number)
   Gentlemen:

   The Environmental Protection Agency hereby informs you of the Agency's
   intention to terminate  the registration  of your  establishment, located
   in (city and state), pursuant to Section 7 of  the  Federal Insecticide,
   Fungicide, and Rodentlcide Act, as aaended, 7  D.S.C.  $136,  and 40
   £.£.&. 1167.3.  Die Agency Intends to take this  action based  on your
   fmllore to submit reports required by Section 7 (c) of the Act and by
   40 C.F.R. S 167.5.

   Tour failure to file the required reports  by (due  date) has already
   subjected you to civil  or criminal penalties under the Act.  Your
   failure to submit the required reports within  twenty  (20) days of your
   receipt of this notice  will result in the  termination of  your
   establishment registration, effective upon the date of the  Agency's
   issuance of a Notice of Termination of Establishment  Registration.
   Tour submission of the  required reports  within the twenty (20) day
   time period shall not affect your liability under  the civil and
   Tou should take all necessary measures to preclude any production at
   your establishment not in compliance with the Act.  Production of
   pesticides, active ingredients, or devices in an unregistered
   establishment or in an establishment whose registration has been
   terminated is an unlawful action subject to the civil and criminal
   penalty provisions of the Act.
                                    .  'Sincerely x-onrs
                                      (Signature, name, and title)
FIFSA Cbvpllance/Enforceaent        6-19               Guidance Manual 1983

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Chapter Six    	           	          Exhibit 6-7
                       Model Notice  of  Termination'of
                         Establishment  Registration
   (Company name)
   (Address)
   Subj ect:  (Establishment registration number)

   Gentlemen:

   The Environmental Protection Agency  hereby Informs you that the Agency
   has terminated the registration  of your establishment, located in
   (city and state), pursuant to Section 7 of the Federal Insecticide,
   Fungicide, and Rodentlcide Act,  as amended, 7  U.S.C.  S136 and 40 C.F.R.
   Si67.3.  The Agency has taken this action based on your failure to
   submit  reports required by Section 7(c) of the Act and by 40 C.F.R.
   S167.5.

   You may apply for reinstatement  of your establishment registration at
   any time subsequent to the termination of your establishment
   registration.  However, the reinstatement of your establishment
   registration will be expressly conditional upon the Agency's receipt
   of your delinquent pesticide report(s) together with  an application
   for establishment registration (EPA  Form 3540-8).

   Tou should take all necessary measures to preclude any production at
   .your establishment not in compliance with the  Act. Production of
   pesticides, active ingredients,  or devices in  an unregistered
   establishment or in an establishment whose registration has been
   terminated is an unlawful action subject to the civil and criminal
   penalty provisions of the Act.

                                      Sincerely yours,
                                       (Signature,  name,  and title)
FZFBA CoBpliance/Enforcesent        6-20               Guidance Manual 1983

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Chapter Six	Exhibit 6-8


                          Proposal for Recall  Fora
   [  ] Formal Recall                              [  ]  Informal Recall

   Region 	 has  decided to  recall  the  product (name of product) for the
   following reasons:   (reasons  for  recall)
   Xeglon _____ requests  that  the  Compliance  Monitoring Staff (and the
   Registration Division,  in the case of  formal  recalls)  review this
   proposed action, based  upon the following evidence,  copies  of which
   are attached:
   [  ] Collection  Report               [  ]  Scientific Review
   [  j Analytical  Reports              [  j  Other - Specify
   „[  J Labels
   Regional Office
                                (Sign  and Date)
   Agreement with  this  recall action  should  be  indicated  with signature
   and date below.   If  there is objection  to this  action, the reason
   should be specified.
   Compliance "Monitoring  Staff
                                         (Sign  and Date)

   Registration Division 	
                                        (Sign and Date)
FIFRA Cbapllance/Bnforceaent        6-21               Guidance Manual  1983

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Chapter Six	Exhibit 6-9
               Model Formal Recall  Request In Connection with
                        Suspension  or Cancellation
   (Company name)
   (Address)


   Sub j ect:  (Name of product and  registration number)

   Gentlemen:

   On (date) the Environmental Protection Agency sent a letter to you
   notifying you that registration under  the  Federal Insecticide,
   Fungicide, and Rodenticide Act, as  amended, 7 D.S.C. §136, for (name
   of product) is (suspended/cancelled)«

   As set forth in the letter of (suspension/cancellation), the Agency
   has determined that (general reason for suspension or cancellation).
   Therefore, the Agency requests  that your company take immediate action
   to withdraw this product from the market.   Specifically, the Agency
   requests:

     1. That your company initiate procedures to determine the locations
        of all quantities of this  product and the amount of such product
        at each location;

     2. That the product be returned to your  company from all such
        locations; and

     3. That you inform us of (a) all  steps your company has taken in
        connection with the recall of  this product, and (b) the
        completeness of the recall action.

   The Agency will supervise this  action  through the office of (name,
   title, address, and telephone number of supervising EPA official).
   Mr./Ma. (name)            , or  a representative of his/her office
   will contact you on this matter.

   Thank you for your cooperation.

                                       Sincerely yours,
                                      (Signature, name, and title)
FIFRA Compliance Knforce-ent        6-22               Guidance Manual 1983

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Chapter Six	Exhibit 6-10


                 Model Formal  Becall Bequest In Connection
                          with Sample Collections
   (Company name)
   (Address)
   Subject:  (Sample number)

   Gentlemen:

   In connection with the enforcement of the  Federal  Insecticide,
   Fungicide, and Rodentlcide Act, as amended,  7  U.S.C.  §136,  the
   Environmental Protection Agency has obtained and tested  a sample of
   the product (name of  the product).  The Agency obtained  this sample
   on (date of inspection) from your producing  establishment located In
   (city and.state).

   Tests of the product  coded (indicate code) showed  the product to be
   (results of tests and their implications for use of the  product).

   In view of the Intended uses of this product,  the  Agency requests that
   your company take Immediate action to withdraw this product from the
   market.  Specifically, the Agency requests:

     1. That your company initiate procedures to  identify the  consignees
        of the product;

     2. That your company request that the consignees return -this product
        \to 
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Chapter  Sis	Exhibit 6-11


                        Model Informal Recall Request
   The Agency  requests  that you take steps to determine whether any
   additional  amounts of this product remain in channels  of  trade.   If so,
   the Agency  further requests that you remove all such lots of the
   product,  coded  (indicate code), from the market.
  Hote:  For an informal  recall  request,  the above paragraph is Inserted
  into the documents  that are  prepared in connection with other enforce-
  ment actions (e.g., civil  penalty,  stop sale,  use, or removal order,
  etc.).
PIFRA Cb»lianee/EnfnrreBW»T?f-         (.-•>&.

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Chapter Six	Exhibit 6-12


                  Model Stop Sale,  Use,  or Removal Order
               UNITED STATES  ENVIRONMENTAL PROTECTION AGENCY

                       STOP SAT.?.,  USE,  OR REMOVAL ORDER

                                                     (Date)
   (Name of persons ordered)                 Sample No(s)

   (Name of company)	

   (Address)	
   By the authority vested  in me  pursuant  to  Section 13(a) of the Federal
   Insecticide, Fungicide,  and  Rodenticide Act, .as amended, 7 D.S.C.
   f 136k, I hereby order yra^^                             the pesticide or
   device (name of product, batch codes, and  other identification).

   Based upon inspection or tests,  the  Environmental Protection Agency
   has reason to believe that the pesticide or device is in violation of
   the provisions of Section  _  of the Act in that the pesticide or
   device (specify violations),

   This order shall pertain to  all  quantities of  the above-named pesti-
   cide or device within the ownership, control,  or custody of the
   above-named person, wherever located.   Said pesticide shall not be
   sold, used, or removed other than in accordance with the provisions
   «f tils «rder or «>f*nch farther orders as vsy be issued in connection
             ^pesticide tnr "device.
   Any person violating  the terms or provisions  of this order shall be
   subject to the penalties described in  Section 14 of the Act,  7 D.S.C.
   §1361.
                                       (Signature,  name,  and title)
   Order served by: (Signature and title of EPA employee,  time and data)
   For Information concerning this Stop Sale, Use, or  Removal Order,
   contact: (Name and title, address and phone number  of  Regional  Office)
FIFBA Caap1.<*"»rr/ffinfnri:cariit        6-25                Guidance Manual  1983

-------
Chapter Six	Tfrhlblt 6-13


           Model Termination of Stop  Sale,  Use,  or Reaoval Order
               UNITED STATES ENVIRONMENTAL  PROTECTION AGENCY

              TERMINATION OF STOP SALE, USE,  OR REMOVAL ORDER


                                              	(Date)
   (Name of person ordered)                   Sample No(s)._

   (Name of company)	

   (Address)	
   The Environmental Protection Agency has  determined  that  (state amount)
   of the pesticide or device named in the  Stop  Sale,  Use,  or Removal
   Order dated (date of order) has been  (method  of approved disposal;
   e.g., registered, relabeled, destroyed,  etc.) as  of (date of  disposi-
   tion).  Therefore, the Stop Sale, Use, or Removal Order  is terminated
   concerning the amount of the pesticide or device  stated  above.  Any
   other amounts of the pesticide or device affected by the order shall
   remain under the effect of the order  until disposed of in the manner
   described above.
                                       (Signature, name, and  title)
FIRA Co«p11 r*f*/**fy*'ewf*+        6-26               Qoidance Mammi 1983

-------
Chapter  Seven

Administrative  Enforcement Actions:
Civil Penalty  Proceedings
Chapter Contents                                        Page


1  Introduction                                          7-1

  Mongol Ida ted JLules of Practice (CROP)                     7-1


2  Elements of a Violation;  Administrative                  7-3


3  Complaint Preparation and Filing                         7-45

   Civil Penalty Complaint Criteria                         7-45
   Delegated Authority                                    7-46
   FIFRA Penalty Assessment 'Considerations                   7-48
   Complaint Preparation                                  7-51
          of t"hf CpgipJjfn*'                              7—32
   Service of the Complaint                                7-55
   Filing the Complaint                                   7-56
   Exhibit 7-1:  Sample Complaint                           7-57
   Exhibit 7-2:  Sample Cover Letter                        7-60
   Exhibit 7-3:  Model Affidavit of Service                   7-61
4  Prehearing Stage                                      7-63

  .Intggggnor* «id ^nicog ;Cgri»e                           7-63
   Agency Files                              *           7-64
   Prohibition of Ex Parte Discussion                      7-66
   Answer to the Complaint                                7-67
   Prehearing Motions                                    7-69
   Default Orders                                       7-71
   Settlement                                           7-73
         fig Oooxf erence  .                               7-74
   fotlon -f or 'Accelerated Decisions and Dismissals            7-77
                                   7-1          Guidance Mf"1"*1 1983

-------
Chapter  Seven         	Contents


5  Hearing Stage                                                 7-81

   Notice of Hearing  and  Venue                                   7-81
   Presentation of  Evidence                                      7-81
   Preponderance of Evidence                                     7-82
   Default Orders and Accelerated Decisions                     7-82
   Hearing Rules of Evidence                                     7-83
   Objections and Rulings                                       7-86
   Offers of Proof                                               7-87
   Transcript of Hearing                                         7-87
   Proposed Findings, Conclusions, and Orders                   7-88
   Motion To Reopen Hearing                                      7-89
   Appeals of Interlocutory Orders or Rulings                   7-90
   Exhibit 7-4:  Sample Default  Order                           7-92
   Exhibit 7-5:  Sample Consent  Agreement  and Final Order       7-95


6  Post-Hearing Stage                                           7-97

   Appeal of Initial  Decision                                    7-97
   Final Order                                                   7-99
   Notice of Judgment                                           7-100
   Payment of Penalty                                           7-100
FIFBA Coapliance/E&forceaeat             7-ii           Guidance Manual 1983

-------
Chapter Seven
1     Introduction
 In nost  instances,  the Regional Office determines those violations  that
 warrant  the  imposition of an administrative civil penalty.  Many violations
 fall  into  this  category.  However, if the violation is sufficiently minor,
 a notice of  warning may be appropriate (see Chapter Six, "Administrative
 Enforcement  Actions:  Notices of Warning and Administrative Orders").
 Conversely,  If
«ay be more  appropriate  (see Chapter Nine , ~ Judicial Enforcement :   Criminal
Actions").   Chapter  Five contains a general discussion of appropriate
enforcement  responses.

This chapter focuses on  FIFRA civil penalty actions and the procedures  for
litigating administratively assessed penalties.
 Consolidated  Rules of  Practice
She Consolidated Rules 
-------
 Chapter  Seven	 Introduction


 In  order to  apply to  national actions,  the CROP require the following
 substitutions of  Agency  officials:

         	Regional	         	National

         Regional  Hearing Clerk         Hearing Clerk

         Regional  Administrator         Administrator

         Regional  Judicial              Judicial Officer
         Officer
Substitutions between regional and  national  officials may also occur If an
official is disqualified pursuant to  the  CROP.   22.04(4)  Certain filing
and service requirements specified  by the CROP  are also altered if the
actions are conducted at the national level. For example, the Regional
Hearing Clerk must forward a record of the proceeding to the Hearing Clerk
when an Initial decision is Issued  In a regional proceeding.  Such a
transfer is unnecessary if the proceeding was conducted at the national
level.  22.
FIFKA Qwpliance/Enforceaent             7-2           Goldaaee MMM! 1983

-------
Chapter Seven
2     Elements  of a Violation:
       Administrative
Under Section 14 of FIFRA, the Agency may issue administrative civil
complaints to persons who violate Section 12 of the Act.  In order to
establish-a prima facie administrative case against a respondent, the
Agency must establish, by proper evidence, each element of the violation
charged.  The following charts list each violation that may occur under
FIFRA, the related elements of proof Chat are necessary to bring the
Eolation to court, and the means by which the element of proof is
established.
 ?IFRA Coapl 1, mtee/Ettforce»ent            7-3          QHdg^^ tfr""*1  1983

-------
Chapter Seven
                               Elements of a  Violation:   Administrative
                            Section 12 (a)(l)(A)
 Any pesticide not registered under Section 3.
      ELEMENTS OP THE VIOLATION
                                       ESTABLISHING THE VIOLATION
1.
2.
Respondent (person) distributed,
sold, offered for sale, held for
sale, shipped, delivered for
shipment, or received and (having
so received) delivered or offered
to deliver a pesticide.

Determination that the product Is
a pesticide.
3.
Determination that the pesticide
is not registered.
4.
Determination that the continued
sale and use of existing stocks
is not permitted under S6(a)(l)
if the product has been cancelled.
Identification of the respon-
sible party for suspected
violation in commerce.  See
"Additional Sources of Documen-
tation" (Chapter 4).
 Appropriate regional or
 Registration Division  (RD)
 personnel review product
 labeling claims to determine
 whether the product is a
 pesticide.  See "Further
 Processing of the ID Jacket--
 Enforcement Case Review"
 (Chapter 4).

 Appropriate regional or RD
 personnel determine regis-
 tration status after a search
 of their files.  See "Further
 Processing of the ID
 Jacket—Enforcement Case
 Review" (Chapter 4).

 Same as No. 3, above.
FIFRA Co»pliance/Enforce*ent
                                  7-4
                            1983

-------
 Chapter  Seven
                                 Elements  of a Violation:  Administrative
                             Section 12 (a)(l)(B)
 Any  registered  pesticide for which any claims made for it as part of its
 distribution  or sale differed substantially from the claims made in
 connection with its  registration.
      ELEMENTS  OF  THE VIOLATION
                                        ESTABLISHING THE VIOLATION
1.
 Respondent (person) distributed,
 sold, offered for sale, held for
 sale, shipped, delivered for
 shipment, or received and (having
 so received) delivered or offered
 to deliver a pesticide.

 Pet era-illation that the product is
-a registered pesticide.
3.
 Claims made for a registered
 pesticide as part of its
 distribution or sale differ
 substantially from the claims
^aade -in connection vitii its
-registration.
 Identification of the respon-
 sible party for suspected
 violation in commerce.  See
 "Additional Sources of Documen-
 tation" (Chapter 4).
^Appropriate regional or ED
 personnel determine registra-
 tion status after a search of
 their files.  See "Further
 Processing of the ID
 Jacket—Enforcement Case
 Review" (Chapter 4).

 Compare copy of pesticide
 label, collected as part of
 the inspection, with registered
 label.  For significance of
 claimed label discrepancies,
 see ~1evel of Action Policy"
 (Chapter 5) and for the penalty
 amount, see Appendix 6.
FIFRA Compllance/Enforc
                                  7-5
                                                     uiance
                             1983

-------
Chapter  Seven
                               ELeaents of a Violation:   Administrative
                             Section 12 (a)(l)(C)
 Any registered pesticide whose  composition differed at the time of Its
 distribution or sale from  the composition described In connection with
 Its registration.
       ELEMENTS OF  THE VIOLATION
                                         ESTABLISHING THE VIOLATION
1.
Respondent (person) distributed,
sold, offered for sale, held for
sale, shipped, delivered for
shipment, or received and (having
so received) delivered or offered
to deliver a pesticide.

Determination that the product Is
a registered pesticide.
    Determination that the composi-
    tion of a pesticide sold or
    distributed in commerce differs
    from the composition under which
    it is registered.
1.  Identification  of  the  respon-
    sible party for suspected
    violation in commerce.   See
    "Additional Sources of  Documen-
    tation" (Chapter 4).
2.  Appropriate regional or ED
    personnel determine registra-
    tion status after a search of
    their files.  See "Further
    Processing of the ID
    Jacket—Enforcement Case
    Review" (Chapter 4).

3.  Chemistry tests determine the
    composition of a pesticide
    sample picked up in commerce.
    These tests are compared with
    registrant's claimed composi-
    tion for discrepancies.  See
    "Laboratory Test Results" under
    "Initial Review of the ID
    Jacket" (Chapter 4).  Appropri-
    ate RD personnel determine the
    significance of any discrep-
    ancy*  See "Further Processing
    of the ID Jacket—Enforcement
    Case Review" (Chapter 4).
FIFRA CoBpllance/Enforceaent
                                 7-6
                Guidance Jlacual 1983

-------
 Chapter  Seven
EL
ts of a Violation:  Administrative
                             Section 12 (a)(l)(D)
Any  pesticide  that has not been colored or discolored pursuant to the
provisions  of  Section 25(c)(5).
       ELEMENTS OF THE VIOLATION
         ESTABLISHING THE VIOLATION
1.  Respondent  (person)  distributed,
    sold, offered  for sale,  held for
    sale, shipped,  delivered for
    shipment, or received and (having
    so  received) delivered or offered
    to  deliver  a pesticide.

2.  Determination  that the product  is
    ji pesticide.
3.  Determination  that  the pesticide
    has not been colored  or discolored
    pursuant  to the  provisions of
    Section 25  (c)(5).
    3.
        Identification of the respon-
        sible party for suspected
        violation in commerce.  See
        "Additional Sources of Documen-
        tation" (Chapter 4).
  Appropriate regional or ED
  personnel review product
  labeling claims to determine
  whether the product is a
  pesticide.  See "Further
  Processing of the ID
  Jacket—Enforcement Case
  Beviev" (Chapter 4).

  Consult 40 C.F.R. $162.13 for
  requirements Imposed on regis-
  trants  to color or discolor
  pesticides.
FIFKA Ckmpliance/Kiforceaent
  7-7
                             1983

-------
Chapter  Seven
Elements of a.  Violation:  Administrative
                      Section 12 (a)(l)(K);  2(q)(l)(A)
 Any pesticide  or  device  that  was  misbranded in that the labeling bore a
 statement, design, or graphic representation that was false or
 misleading.
     ELEMENTS OF  THE  VIOLATION
        ESTABLISHING THE VIOLATION
    Respondent (person) distri-
    buted, sold, offered  for sale,
    held for sale, shipped,
    received and (having  so
    received) delivered or offered
    to deliver a pesticide or
    device.

    Determination that the product
    Is a pesticide or device.
    Determination that the
    pesticide or device was
    misbranded in that its labeling
    bore a statement or graphic
    representation that was false
    or misleading, I.e.:

    •  A false or misleading
       statement concerning the
       composition of the product;

    •  A false or misleading
       statement concerning the
       effectiveness of the product
       as a pesticide or device;

    •  A false or misleading
       statement concerning the
       value of the product for
       purposes other than as a
       pesticide or a device;

    •  A false or misleading
       comparison with other
       pesticides or devices;
      Identification of the responsible
      party for suspected violation in
      commerce.   See "Additional
      Sources of  Documentation"
      (Chapter 4).
      Appropriate regional  or RD
      personnel review product labeling
      claims to determine whether  the
      product is a pesticide  or device.
      See "Further Processing of the  ID
      Jacket—Enforcement Case Review"
      (Chapter 4).

      Consult 40 C.F.R J162.10(a)(5) for
      requirements Imposed  on products
      to prevent misbranding.  Compare
      copy of pesticide label collected
      as a part of Inspection with
      registered label. If available,
      RD will review efficacy data for
      the product.  For the signifi-
      cance of mlsbrandlng, see "Level
      of Action Policy"  (Chapter 5) and
      for the penalty  amount, see
      Appendix 6.
FIFRA Gcmpliance/Enforceaent
7-8
Guidance Manual 1983

-------
 Chapter Seven
 Elements of a Violation
       ELEMENTS OF THE VIOLATION
        ESTABLISHING THE VIOLATION
     •  Any statement directly or
        indirectly implying that the
        pesticide or device is
        recommended or endorsed by
        any agency of the Federal
        government ;

     •  The name of a pesticide
       .containing two or acre
        principal active Ingredients
        If the name suggests one or
        more but not all such
        principal active
        ingredients, even though the
        names of the other
        ingredients are stated
        elsewhere in the labeling.

     •  A true statement used in
        such a way as to give a
        false or misleading
        impression to the purchaser;

     •  Label disclaimers that
        negate or detract from
        labeling statements required
        under the Act and
        Implementing regulations;

   H* -Claiafi *s to the safety of
       the pesticide or its
        ingredients, Including
        statements such as "safe,"
        "nonpoi s onous , "  "non-
       injurious,"  "harmless,"  or
        "nontoxic to humans and
       pets"  with or without such a
       qualifying phrase as "when
                     £*d"; mad
       Non-numerical  and/or
       comparative  statements on
       the safety of  the  product,
       including but  not  limited
       to:
          ingredients,"
       -  "Among  the least  toxic
          chemicals known,"  or
       -  "Pollution approved."
F1KKA Compliance/Enforceaent
7-9
Guldi
Manual .1983

-------
 Chapter  Seven
Elements of a. Violation:   Administrative
                      Sections 12(a)(l)(E); 2(q)(l)(B)
 Any  pesticide  or  device  that  was misbranded in that it was contained in
 package or  other  container  or wrapping which did not conform to the
 standards established by Section 25(c)(3).
      ELEMENTS  OF  THE  VIOLATION
       ESTABLISHING THE VIOLATION
    Respondent (person) distri-
    buted, sold, offered  for  sale,
    held for sale, shipped,
    received and (having  so
    received) delivered or offered
    to deliver a pesticide or
    device.

    Determination that the product
    is a pesticide or device.
    Determination that  the pesti-
    cide or device has  not been
    properly packaged.
      Identification  of  the  responsible
      party for suspected  violation In
      commerce.   See  "Additional
      Sources of  Documentation"
      (Chapter 4).
      Appropriate regional  or  RD
      personnel review product labeling
      claims to determine whether  the
      product is a pesticide or device.
      See "Further Processing  of the ID
      Jacket—Enforcement Case
      Review"(Chapter  4).

      Consult 40 C.F.R. S162.16 for the
      requirements Imposed  on  regis-
      trants to package pesticide
      products or devices In a manner
      that prevents injury  or  Illness.
      Also see Child-Resistant Pack-
      aging Guidelines  issued  by
      PTSCMS.  If determination cannot
      be made, refer to RD  personnel.
      For the significance  of
      deficiencies, see "Level of
      Action Policy" (Chapter  5) and
      for the penalty amount,  see
      Appendix 6.
PZFRA QoBpliance/Enf orceaeat
7-10
Guidance Manual 1983

-------
 Chapter Seven
 Elements of a Violation:  Administrative
                     Sections 12(a)(l)(E); 2(q)(l)(C)
  Any pesticide or device that was mlsbranded In that It was an imitation
  of,  or  was  offered for sale tinder the name of, another pesticide or
  device.
      ELEMENTS OP THE VIOLATION
        ESTABLISHING THE VIOLATION
     Respondent (person) distri-
     buted,  sold,  offered for sale,
     held  for sale,  shipped,
     received and  (having so
     received) delivered or offered
     to  deliver a  pesticide or
     device.

     Determination that the product
     Is  a  pesticide  or device.
    Determination that the pesti-
    cide  or  device was mlsbranded
       that  it  »as offered for  sale
    cide or device,  i.e.:

    •  A manufacturer duplicated
       the composition of  another
       pesticide  and offered it  for
       sale under the name of that
       pesticide.
       Identification of the responsible
       party for suspected violation in
       commerce.  See "Additional
       Sources  of Documentation"
       (Chapter 4).
      Appropriate  regional or RD
      personnel  review product
      labeling claims  to  determine
      whether the  product is  a
      pesticide  or device. See
      "Further Processing of  the ID
      Jacket—Enforcement Case Review"
      (Chapter 4).

      Appropriate  regional or RD
      personnel  determine that
      manufacturer  of product-is aot
      "the -producer  registered to
      manufacture  that  product.   See
      "Scientific Review"  under
      "Further Processing  of  the ID
      Jacket—Enforcement  Case Review"
      (Chapter 4).
FIFRA Co»pl1ance/Bnforceaeat
7-11
Guidance ***"«"• 1 1983

-------
Chapter  Seven
                               Elements  of  a Violation;  Adolnistratlve
                      Sections  12(a)(l)(K);  2(q)(l)(D)
  Any pesticide or device  that  was  misbranded in that its label did not
  bear the assigned registration  number  of  the establishment in which it
  was produced.
      ELEMENTS OF THE VIOLATION
                                       ESTABLISHING THE VIOLATION
2.
Respondent (person) distri-
buted, sold, offered for sale,
held for sale, shipped,
delivered for shipment, or
received and (having so
received) delivered or offered
to deliver a pesticide or
device.

Determination that the product
Is a pesticide or device.
                                          Identification of the responsible
                                          party for suspected violation in
                                          commerce.  See "Additional
                                          Sources  of Documentation"
                                          (Chapter 4).
3.
Determination that the label of
the pesticide or device, did not
bear the assigned registration
number of the establishment in
which it was produced.
Appropriate regional or  ED
personnel review product labeling
claims to determine whether the
product is a pesticide or device.
See "Further Processing  of the ID
Jacket—Enforcement Case Review"
(Chapter 4).

Appropriate regional or  PTSCMS
personnel review product label-
Ing to determine whether the
appropriate establishment
registration number appears on
the label collected during the
inspection.  Consult 40  C.F.R.
f!62.10(e) for requirements.  For
the significance of the omission,
•ee "Level of Action Policy"
(Chapter 5) and for the penalty
amount, see Appendix 6.
FIFKA Gmpliance/Enfor
                               7-12
                              1983

-------
Chapter  Seven
Elements of a Violation:  Administrative
                      Sections 12(a)(l)(B); 2(q)(l)(B)
 Any pesticide  or  device that  was misbranded In that words, statements, or
 other Information that Is required to appear on the label or labeling was
 not .prominently placed thereon with such consplcuousness and In such
 terms as to render It  likely  to be read and understood by the ordinary
 Individual under  customary conditions of purchase and use.
      ELEMENTS  OF TEE VIOLATION
        ESTABLISHING THE VIOLATION
    Respondent  (person) distri-
    buted, sold,  offered for sale,
    held for  sale,  shipped,
    delivered for shipment, or
    received  and  (having so
    received) delivered .or offered
    to.deliver  a  pesticide or
    device.

    Determination that  the product
    is a pesticide  or device.
  1.
 Identification of the responsible
 party for suspected violation in
 commerce.  See "Additional
 Sources of Documentation'*
 (Chapter 4).
  2.
    Determination  that  the label  or
   :iyfr»i^nj "tff "the .pesticide or
    device does not  conform to  the
    format required  by  the
    product's regis tration.
 Appropriate regional or RD per-
 sonnel review product labeling
 f>ia-tmti to determine whether the
 product is a pesticide or device.
 See "Further Processing of the ID
 Jacket—Enforcement Case Review"
 (Chapter 4).

 Appropriate- regional or JU> per-
-'AOQDel review.,product .labeling 'to
 determine conformance with the
 label accepted in conjunction
 with the registration.  Consult
 40 C.F.R. $162.10(a)(2) for
 "Prominence and Legibility"
 requirements.  For the signifi-
 cance of the discrepancies, see
 "Level *>f ^action »Pollcy~  (Chapter
 5)^*nd &>r ^ite •penalty' utotxnt,
 *ee Appendix 6.
FIFRA Coapliance/Bafon
7-13
Guidance
                               1983

-------
 Chapter  Seven
                                Eleaents  of a Violation:  Administrative
                      Sections 12(a)(l)(K); 2(q)(l)(F)
 Any  pesticide  or  device  that  was  misbranded in that the labeling accom-
 panying  it  did not  contain  the  directions for use that are necessary for
 effecting the  purpose  for which the product is intended, and if complied
 with together  with  any requirements imposed under Section 3(d) of the
 Act, are adequate to protect  human health and the environment.
     ELEMENTS  OF  THE  VIOLATION
                                       ESTABLISHING THE VIOLATION
    Respondent  (person)  distri-
    buted, sold, offered for  sale,
    held for sale,  shipped,
    delivered for shipment, or
    received and (having so
    received) delivered  or offered
    to deliver  a pesticide or
    device.

    Determination that the product
    Is a pesticide  or device.
                                      Identification of the responsible
                                      party  for  suspected violation in
                                      commerce.   See "Additional
                                      Sources of Documentation"
                                      (Chapter 4).
3.
Determination that the direc-
tions for use did not meet the
requirements Imposed for the
protection of health and the
environment by the Act and
Implementing regulations.
Appropriate regional  or  RD  per-
sonnel review product labeling
claims to determine whether the
product is a pesticide or device.
See "Further Processing  of  the ID
Jacket—Enforcement Case Review"
(Chapter 4).

Appropriate regional  or  RD
personnel review product labeling
to determine whether  the label
obtained during  Inspection  con-
forms to the label accepted in
conjunction with the  product's
application for  registration.
Consult 40 C.F.R. S162.10(1) for
requirements. For the signifi-
cance of the discrepancies,  see
"Level of Action Policy" (Chapter
5) and for the penalty amount,
see Appendix 6.
FIFSA Gcmpliance/Bnforeesent
                               7=14
Guidance
                              1983

-------
Chapter Seven
                                EL
ts of a Violation:  Administrative
                      Sections  12(a)(l)(K); 2(q)(l)(6)
 Any pesticide or  device  that  was  misbranded in that the label did not
 contain a warning or  caution  statement which is necessary, and if
 complied with,  together  with  any  requirements Imposed under Section 3(d)
 of the Act, is  adequate  to protect  human health and the environment.
     ELEMENTS OF THE VIOLATION
                                       ESTABLISHING THE VIOLATION
1.
2.
Respondent (person)  distri-
buted, sold, offered for sale,
held for sale,  shipped,
received and (having so
received) delivered  or offered
to deliver a pesticide or
device.

Determination that the product
is a pesticide  or device.
3.
Determination that  the. 'warning
                      of the Act
    and/or Implementing regula-
    tions.
1.
2.
3.
Identification of  the  responsible
party for suspected violation  in
commerce.  See "Additional
Sources of Documentation"
(Chapter 4).
Appropriate regional or RD
personnel review product
labeling claims to determine
whether the product is a
pesticide or device.  See
"Further Processing of the ID
Jacket— Enforcement Case Review"
(Chapter 4).

Appropriate regional or RD j>er-
       review product ?«tM»]i«  to
                                     determine  whether the label
                                     obtained during the Inspection
                                     conforms to  the label accepted in
                                     conjunction  with the product's
                                     application  for registration.
                                     Consult 40 C.F.R. f!62.10(b) for
                                     requirements.  For the signifi-
                                     cance of the discrepancies* «ee
                                     -Level of  Action Policy"  (Chapter
                                     5) and for the penalty amount,
                                     •ee Appendix 6.
                                   7-15
                                                   Guidance Manual  1983

-------
 Chapter  Seven
Elements of a Violation:   Administrative
                      Sections  12(a)(l)(B);  2(q)(l)(H)
 Any nonregistered  pesticide  intended  for export that was misbranded in
 that  the  statement,  "Not  registered for use in the United States," was
 not prominently placed on the label.
     ELEMENTS  OF THE VIOLATION
       ESTABLISHING THE VIOLATION
    Respondent (person) distri-
    buted, sold, offered for sale,
    held for sale, shipped,
    delivered for shipment, or
    received and (having so
    received) delivered or offered
    to deliver a pesticide.

    Determination that the product
    is a pesticide.
    Determination that  the  product
    is not registered.
    Determination that the required
    statement was not prominently
    placed on the label.
      Identification  of  the  responsible
      party for suspected  violation  in
      commerce.  See  "Additional
      Sources of Documentation"
      (Chapter 4).
      Appropriate regional  or  RD
      personnel review product labeling
      claims to determine whether  the
      product is a pesticide.   See
      "Further Processing of the ID
      Jacket—Enforcement Case Review"
      (Chapter 4).

      Appropriate regional  or  RD
      personnel determine registration
      status after a search of their
      files.  See "Further  Processing
      of ID Jacket—Enforcement Case
      Review" (Chapter  4).

      Appropriate regional  or  RD
      personnel review  pesticide label
      to determine whether  the required
      statement was prominently placed.
      For the significance  of  its
      omission, see "Level  of  Action
      Policy" (Chapter  5) and  for  the
      penalty amount, see Appendix 6.
FZFEA Compliance/Soforceaent
7-16
Guidance Manual 1983

-------
 Chapter Seven
                                ELeaents  of a Violation:   Administrative
                       Sections  12(a)(l)(E);  2(q)(2)(A)
  Aay pesticide that was misbranded in that  the  label  did not  bear an
  ingredient statement on  that part of the immediate container that is
  presented or displayed under customary conditions of purchase,  or on
  another part of the immediate container, or on the outside container or
  wrapper, as permitted by the Administrator.
      ELEMENTS OF THE VIOLATION
                                     . ESTABLISHING THE VIOLATION
 1.
 2.
Respondent (person) distri-
buted, sold, offered for sale,
held for sale, shipped,
delivered for shipment, or
received and (having so
received) delivered or offered
to deliver a pesticide.

Determination that the product
is a pesticide.
 3.
Determination that the product
label bears the ingredient
      mt In ;the .appropriate
         except: where i
        The size or fora of the
        product container makes it
        Impracticable to place the
        statement on the part of
        the label displayed to
        purchasers; and

       "The'Statement 'appears promi-
        nently in another position
        as permitted.
1.  Identification of the responsible
    party for suspected violation  in
    commerce.  See "Additional
    Sources of Documentation"
    (Chapter 4).
2.  Appropriate regional or RD per-
    sonnel review product labeling
    claims to determine whether the
    product is a pesticide.  See
    "Further Processing of the ID
    Jacket—Enforcement Case Review"
    (Chapter 4).

3.  Appropriate regional or RD
    personnel review the product
    lahfllug to determine whether ±he
    label obtained during Inspection
    conforms to the label accepted in
    conjunction with the product's
    application for registration.
    Consult 40 C.F.R. §162.10(g)(2)
    for the requirements.  For the
    significance of the discrep-
    ancies, see "Level of Action
    Policy' (Chapter 5) and Jor she
    penalty amount, see Appendix 6.
TTF1A Taompllance/EnlorcPacnt
                               7-17
                                                    u
                                  1983

-------
Chapter Seven
                                Elements  of a Violation:  Administrative
                    Sections 12(a)(l)(E);  2(q)(2)(B)
 Any pesticide that was mlsbranded in that  the  labeling did not contain a
 statement of the use classification under  which  the  product was
 registered.
     ELEMENTS OF THE VIOLATION
                                       ESTABLISHING THE VIOLATION
1.
2.
Respondent (person) distributed,
sold, offered for sale, held
for sale, shipped, delivered
for shipment, or received and
(having so received) delivered
or offered to deliver a
pesticide.

Determination that the product
is a pesticide.
3.
Determination that the product
label does not bear the re-
quired statement of use
classification, or does not
bear the appropriate state-
ment In the proper position or
size.
                                     3.
                                          Identification of the responsible
                                          party  for  suspected violation in
                                          commerce.   See "Additional
                                          Sources of Documentation"
                                          (Chapter 4).
Appropriate regional or  RD
personnel review product labeling
claims to determine whether the
product is a pesticide.  See
"Further Processing of the ID
Jacket—Enforcement Case Review"
(Chapter 4).

Appropriate regional or  RD
personnel review product label to
determine whether the label
obtained at the inspection
conforms to the label accepted in
conjunction with the product's
registration application.
Consult 40 C.F.R. $162.10(j) for
the requirements.  For the
significance of the discrep-
ancies, see "Level of Action
Policy" (Chapter 5) and  for the
penalty amount, see Appendix 6.
FXFRA Coapliance/Enforceaent
                                   7-18
                                                   Guidance Manual  1983

-------
 Chapter  Seven
                                Elements of a Violation:  Administrative
                      Sections 12(a)(l)(E); 2(q)(2)(C)
 Any pesticide  that  was  misbranded in that there was not affixed to its
 container, and to the outside container or wrapper of the retail package,
 if there be one, through which the required information on the immediate
 container cannot be clearly read, a label bearing the required
 Information.
     ELEMENTS  OF  THE VIOLATION
                                       ESTABLISHING THE VIOLATION
    Respondent  (person)  distri-
    buted, sold, offered for sale,
    held for  sale,  shipped,
    delivered for shipment,  or
    received  and {having so
    received) delivered  or .offered
    to deliver  a pesticide.

    Determination that the product
    is a pesticide.
                                  1.
                                  2.
3.
Determination that  the  product
label jdoes not bear the
following required  Information:

•  The name and address of  the
   producer, registrant, or
   person for whom  the
   pesticide was produced;

•  The name, brand,,  or

   pesticide Is sold;

•  The net weight or measure of
   the contents, unless an
   exemption Is granted by  the
   Administrator; and
       assigned to the pesticide
       and the use classification.
3.
    Identification of the responsi-
    ble party for suspected violation
    in commerce.  See "Additional
    Sources of Documentation"
    (Chapter 4).
    Appropriate regional or RD
    personnel review product labeling
    claims to determine whether the
    product is a pesticide.  See
    "Further Processing of the ID
    Jacket—Enforcement Case Review"
    (Chapter A).
Appropriate regional or JU>
personnel review product ly
                                          to determine if the label
                                          obtained In the Inspection
                                          conforms to the label accepted in
                                          conjunction with the product's
                                          application for registration.
                                          For the significance of the
                                          omissions,  see "Level of Action
                                          Policy" .(Chapter 5} and £or the
                                                          aee Appendix 6.
PIFEA Ckmpliance/Bnforceaent
                               7-19
              Guiance
                                  1983

-------
Chapter Seven
                               Elements of a Violation:   Administrative
                     Sections 12(a)(l)(E);  2(q)(2)(D)
 Any pesticide that was misbranded in that it  contained a substance or
 substances highly toxic to humans and its label failed to bear:

    •  The skull and crossbones;

    •  The word "Poison" in red on a distinctly contrasting background;
       and

    •  A statement of practical treatment (first aid  or otherwise) in case
       of poisoning.
     ELEMENTS OF THE VIOLATION
                                      ESTABLISHING THE VIOLATION
    Respondent (person) distri-
    buted, sold, offered for sale,
    held for sale, shipped,
    delivered for shipment, or
    received and (having so
    received) delivered or offered
    to deliver a pesticide.

    Determination that the product
    is a pesticide.
3.
Determination that the product
label does not bear the
required statements or
designs.
                                     Identification  of  the  responsi-
                                     ble party for suspected  violation
                                     in commerce.  See  "Additional
                                     Sources of Documentation"
                                     (Chapter 4).
Appropriate regional or  RD per-
sonnel review product  labeling
claims to determine whether  the
product is a pesticide.   See
"Further Processing of the ID
Jacket—Enforcement Case Review"
(Chapter 4).

Appropriate regional or  RD
personnel review the product
labeling to determine whether the
label obtained during  Inspection
conforms to the label  accepted In
conjunction with the product's
registration application.
Consult 40 C.F.R. Sl62.10(h) for
the requirements.  For the
significance of the omission, see
"Level of Action Policy"  (Chapter
5) and for the penalty amount,
see Appendix 6.
FIFRA Compliance/Enfor
                               7-20
Guidance
                              1983

-------
 Chapter  Seven
                                Elements of a Violation:  Adainlstratli
                         Sections 12(a)(l)(E); 2(c)
  Any  pesticide  that was adulterated in that:

    •   Its  strength or purity fell below the professed standard of quality
        under which It was sold;

    •   Another substance had been substituted wholly or in part for the
        pesticide;  or

    •   A valuable  constituent of the pesticide had been wholly or in part
        abstracted.
     ELEMENTS OF  THE VIOLATION
                                       ESTABLISHING THE VIOLATION
    Respondent  (person)  distri-
    buted, sold,  offered for/sale,
    held  for  sale,  shipped,
    delivered for shipment, or
    received  and  (having so
    received) delivered  or offered
    to deliver  a  pesticide.

    Determination that the product
    is a  pesticide.
                                  1.  »Identification of the responsible
                                   .-.»• party for suspected violation in
                                      commerce.  See "Additional
                                      Sources of Documentation"
                                      (Chapter 4).
                                 2.
3.
Determination that the product
was adulterated in a manner
described by the Act.
3*
 Appropriate regional or RD per-
 sonnel review product labeling
 claims to determine whether  the
 product Is a pesticide.   See
 "Further Processing o£ the ID
 ", Jacket— •Enforcement Case J&eviev"
 (Chapter 4).

 Appropriate regional or RD per-
 sonnel review chemistry labora-
 tory tests to determine whether
 the product composition conforms
 to the composition accepted  In
 . conj unrflon v±ch the application
>for vXftglatratloii.  See
 "Scientific Review" under
 "Further Processing of the ID
 Jacket— Enforcement Case Review"
 {Chapter 4).  For the
 significance of the adultera-
 tion, see "Level of Action
             pt«r 5) «nd for tbe
                                         ?enalty eooont,  see Appendix 6.
FIPBA Ocmpliance/Enfor
                               7-21
               Guidance

-------
Chapter Seven
Elements of a. Violation:   Administrative
                           Section 12(a)(2)(A)
 A person detached, altered, defaced, or destroyed, in whole  or  in  part,
 labeling required under the Act.
     ELEMENTS OF THE VIOLATION
       ESTABLISHING  THE VIOLATION
1.  Determination that the sampled
    label had been detached,
    altered, defaced, or destroyed,
    in whole or in part.
  1.  Review documentation of the
      violation  to determine the extent
      of the violation.   See "Other
      Evidential Documentation*' under
      "Initial Review of  the ID
      Jacket" and "Labeling Review"
      under "Further  Processing of  the
      ID Jacket—Enforcement Case
      Review" (Chapter 4).  For the
      significance of the alleged
      violation, see  "Level of Action
      Policy" (Chapter 5) and for the
      penalty amount,  see Appendix  6.
      Csapliaace/Soforceaent
7-22
Guidance
1983

-------
Chapter Seven
                                    Elements of a Violation:  Administrative
                            Section 12(a)(2)(B)
 A  person refused to keep records required by Section 8 or by 40 C.F.R.
 Part  169.
     ELEMENTS OF THE VIOLATION
                                           ESTABLISHING THE VIOLATION
1.
    Determination, that pesticide
    or  device  producer did not
    maintain the following records:

    •   Records showing:

        -  Product name
        -  EPA  registration number
          number (If applicable)
       -  Batch amounts
       -  Batch identification
       -  Production control
          records
       -  Complete formula if
          required

       Brand  names and  quantities
       of pesticides or devices
       produced .   Records of -
       producer receipts of pesti
       cides, devices,  Active
       Ingredients used in pro-
       ducing pesticides.

       —  Brand name/ common or
          chemical riamo
       -  Name  and address of
          shipper
      • -"•, ->_JIaae -of
1.  Regional personnel review copies
    of records obtained during
    Inspection to determine whether
    the records are maintained.  See
    "Other Evidential Documentation"
    under "Initial Review of the ID
    Jacket" (Chapter 4).  Consult 40
    C.F.R. Part 169 for the require-
    ments.  For the significance of
    the alleged violation, see "Level
    of Action Policy" (Chapter 5) and
    for the penalty amount, see
    Appendix 6.
               received
       -  Quantities  received

       Records regarding shipment
       of pesticides, devices,  and
       active ingredients.


          chemical name
       -  Name and address  of
          consignee
FIFKA CoMpllance/Enf or<
                                   7-23
Guia
                                  1983

-------
 Chapter  Seven
 Elements of a Violation;  Administrative
      ELEMENTS OF THE VIOLATION
        ESTABLISHING THE VIOLATION
        -  Name of originating
           carrier
        -  Date shipped or delivered
           for shipment
        -  Quantities  shipped or
           delivered for shipment
        -  Distribution information
           required for pesticides
           produced pursuant  to  an
           experimental use permit,
           a  special exemption,  or a
           special local need

    •   Inventory  records of  items
        produced.

        -  Types
        -  Amounts of  pesticides or
           active  ingredients
        -  Quantities  of devices

    •   Copies  of  all  domestic
        advertising of restricted
        uses.

    •   Copies  of  all  guarantees.

    •   For items  Intended solely
        for export

        -  Copies  of foreign  pur-
           chaser's specifications
           or directions for  pro-
           duction
        -  Copies  of labels or
           labeling
        -  Copies  of statement
           signed  by foreign
           purchaser acknowledging
           that  the Item Is not
           registered  for use and
           cannot  be sold for use In
           the U.S. (Must be
           obtained for the first
           shipment of a particular
           product to  a particular
           purchaser each year.)
FZFRA Gmpliance/Eofori
7-24
Manual 1983

-------
 Chapter  Seven
 Elements of a Violation:  Administrative
      ELEMENTS OF THE VIOLATION
        ESTABLISHING THE VIOLATION
     •   Records on disposal

        -  Method
        -  Dates
        -  Sites
        -  Types of pesticides
        —  Amounts

     •   Secords of tests on humans.
        The following records of
        tests  on human beings must
        be  maintained for 20 years
        or  sent to EPA after 3 years

        -  Name and address of
           subject
        -  Test dates
        — .Test types
        -  Written consent of
           subject
        -  All information and
           instructions given to
           subj ect
        -  Any adverse effects of
           tests on subjects

     •   Research data records

        -  Test reports sent to EPA
       .   in  support of:

          •   Registration
          •   Tolerance petition
          •   All  underlying raw
              data with their inter-
              pretations and evalua-
              tions
FIFBA QmpH ance/Eofo
7-25
Guidance
1983

-------
Chapter Seven
Elements of a Violation:  Administrative
                           Section 12(a)(2)(B)
 A person refused to allow  the  Inspection of  any records or of an estab-
 lishment pursuant to Section 8 or 9.*
     ELEMENTS OF THE VIOLATION
       ESTABLISHING THE VIOLATION
1.  Determination that the agent
    in charge of a FIFRA-regulated
    establishment did not allow the
    inspector entry for purposes of
    conducting an Inspection or
    examination of records.
  1.  Review inspector's documentation
      that he or she was denied  entry
      into the establishment  for pur-
      poses of conducting an  Inspection
      or examination of records.   Docu-
      mentation should include the name
      and position of the company
      official who refused  entrance  or
      records examination,  a  summary
      of the conversation or  events,
      and the date and time of the
      denial.
* In N. Jonas and Company Inc., I.F.&R. Docket No.  III-121C (July 27,
  1978), an Administrative Law Judge held  that, even  after the Supreme
  Court's decision in Marshall v. Barlow's Inc.. 436  U.S.  307  (1978)  [see
  Three Warrants in Chapter Three], the refusal to  allow a warrantless
  inspection of a FIFRA-regulated establishment properly subjected the
  owner to an administratively assessed civil penalty.
FIFKA
7-26
1983

-------
 Chapter Seven
 Eleaents  of a Violation:   Administrative
                            Section 12(a)(2)(B)
  A person refused to allow an officer or employee of the Environmental
  Protection Agency to take a sample of any pesticide pursuant to
  Section 9.
      ELEMENTS OF THE VIOLATION
        ESTABLISHING THE VIOLATION
 1.   Determination that the agent
     in charge of the establishment
     did not  allow the inspector to
     take a sample of a pesticide.
      Review inspector's  documentation
      that  he or she  was  denied the
      right to take a pesticide sample.
      Documentation should include the
      name  and position of the company
      official who disallowed the
      inspector to take a sample of the
      pesticide,  a summary of .the
      conversation or events, and the
      date  and time of the denial.
FIFRA Ooapliance/Enforceaent
7-27
ui
1983

-------
 Chapter  Seven
Eleaentg of  a Violation;  Administrative
                            Section 12(a)(2)(C)
 A person gave a guaranty or undertaking provided for din Section 12(b)
 that was false In any particular.
     ELEMENTS OF THE VIOLATION
       ESTABLISHING THE VIOLATION
1.  Determination that guaranty  of
    registration and compliance
    with the Act meet the require-
    ments of the Act and Imple-
    menting regulation.
  1.  Consult 40 C.F.R.  S162.12  for
      regulatory requirements  and
      sample guaranty.   Review copies
      of guaranty obtained  during
      inspection.   See "Other
      Evidential Documentation"  under
      "Initial Review of the ID  Jacket'
      (Chapter 4).  For  the signifi-
      cance of the  alleged  violation,
      see "Level of Action  Policy"
      (Chapter 5) and for the  penalty
      amount, see Appendix  6.
FIF1A Compliance/Enfor
7-28
Guidanc
n^i 1983

-------
 Chapter  Seven
Elegants  of a Violation:   Administrative
                            Section 12(a)(2)(D)
 A person  used  to personal advantage or revealed to persons other than
 those  authorized by the Act any confidential information acquired under
 the Act.
      ELEMENTS OF THE VIOLATION
        ESTABLISHING THE VIOLATION
1.  Determination that confidential
    information was  used for per-
    sonal advantage.
      Conduct  investigation to
      determine whether  respondent had
      access to confidential informa-
      tion and whether such information
      was revealed  to unauthorized per-
      sonnel for respondent's personal
      advantage.  Investigation
      should include;

      •  Interviews  (affidavits) with
         the party suspected of
         releasing  the information;

      •  The party(ies)  suspected  of
         receiving  the confidential
         information; and

      •  Any other Individual with
         knowledge of the Incident.

      •'for .^significance of the alleged
      disclosure, see "Level of Action
      Policy"  (Chapter 5) and for  the
      penalty  amount, see Appendix 6.
FIFBA CoBpliance/Biforceaent
7-29
Guidance
1983

-------
Chapter Seven
                               Elements of a Violation:  Administrative
                            Section  12(a)(2)(K)
 A person advertised, in his or her capacity as  a registrant, wholesaler,
 dealer, retailer, or other distributor,  a  pesticide  registered for
 restricted use without giving the classification assigned under Section 3
 of the Act.
     ELEMENTS OF THE VIOLATION
                                      ESTABLISHING  THE VIOLATION
1.
Determination that the product
is a pesticide registered for
restricted use.
2.
Determination that a
restricted use pesticide was
advertised for sale without its
appropriate use classifi-
cation.
Appropriate regional or RD
personnel determine registration
status after a search of  their
files.  See "Further Processing
of the ID Jacket—Enforcement
Case Review" (Chapter 4).

Review product advertising to
determine whether the use classi-
fication is included.  For list
of restricted use pesticides, see
40 C.F.R. 1162.31.  See "Labeling
Review" under "Further Processing
of the ID Jacket—Enforcement
Case Review" (Chapter 4).  Appro-
priate regional RD personnel
determine product classification
status.  For the significance of
the omission, see "Level of
Action Policy" (Chapter 5) and
for the penalty amount, see
Appendix 6.
FIFRA Gmpliance/Bnforceaseat
                               7=30
              Guidance Manual 1983

-------
 Chapter  Seven
Elements of  a Violation:   Adainlstratlve
                            Section 12(a)(2)(F)

 A person made  available for use or used a restricted use pesticide for
 any  purpose  other  than in accordance with Section 3(d) and any regula-
 tions  thereunder.
      ELEMENTS  OF THE VIOLATION
       ESTABLISHING THE VIOLATION
1.  Determination' that the product
    is a pesticide.
2.  Determination that a restricted
    use pesticide was made available
    for use or used  in a manner not
    in accordance with the uses
    allowed for  the  product's
    registration.
      Appropriate  regional  or  RD
      personnel review  product labeling
      claims  to determine whether the
      product is a pesticide.   See
      "Further Processing of the ID
      Jacket—Enforcement Case Review"
      (Chapter 4).

      Consult 40 C.F.R. $162.31 to
      determine whether the product
      contains an  active Ingredient
      that requires a restricted use
      classification.   Review  inspec-
      tor's report to determine whether
      dealer sold  restricted use pesti-
      cide to inappropriate, person or,
      if appropriate whether pesticide
      was Improperly used.  Review
      product label to determine use
      classification.   See  "Labeling
      Bevlew" under "Further 'Processing
      •of the ID Jacket—Enforcement
      Case Review" (Chapter 4).   For
      the significance of the  alleged
      violation, see "Level of  Action
      Policy" (Chapter 5) and  for  the
      penalty amount, see Appendix 6.
FIFRA Co*pliance/Enfori
7-31
Guidance Mrniirf'1 1983

-------
Chapter Seven
                                        of  a  Violation;  Administrative
                            Section 12(a)(2)(G)
 A person used a registered pesticide  in a manner Inconsistent with its
 labeling.
     ELEMENTS OF THE VIOLATION
                                      ESTABLISHING THE VIOLATION
1.
Determination that the product
is a registered pesticide*
2.
Determination that the product
was used in a manner inconsis-
tent with its labeling.
Regional personnel ensure  that
product is registered through
regional files or RD review.
Review accepted label to deter-
mine acceptable uses.   See
"Labeling  Review" under "Further
Processing of the ID Jacket-
Enforcement Case Review" (Chapter
4).

Review documentation to determine
whether the actions of  the
respondent (use of the  pesticide)
were inconsistent with  the
product's label.  For the
significance of the alleged
violation, see "Level of Action
Policy" (Chapter 5) and for the
penalty amount, see Appendix 6.
FIFRA Cbmpliance/Knfor
                               7-32
              Guidance Manoal 1983

-------
 Chapter Seven
 Elements  of a Violation:   Administrative
                            Section 12(a)(2)(H)
  A person used a pesticide that was under an experimental use permit
  contrary to the provisions of the permit.
      ELEMENTS OF THE VIOLATION
       ESTABLISHING THE VIOLATION
 1*   Determination that pesticide Is
     under an experimental use
     permit.

 2.   Determination that use of the
     pesticide violated the terms of
     the permit.  The permit will
     specify the following:

     • Duration of the permit;

     •  Limitations and uses;

     •  Additions;

     •  Records maintenance
        requirements;

     •  Labeling requirements; and

     •  Reporting requirements.
   1.  Appropriate  RD personnel  verify
      that pesticide is under a permit.
      Consult permit issued by  RD and
      40 C.F.R. Part 172 for  terms  and
      conditions of permit.   Compare
      with inspection documentation to
      determine nature of alleged
      violation.  See ""Other  Evidential
      Documentation" under "Initial
      Review of the ID Jacket"  (Chapter
      4).  For the significance of  the
      alleged violation, see  "Level of
      Action Policy" (Chapter 5)  and
      for the penalty amount, see
      Appendix 6.
TIFBA Compllance/Enforceaent
7-33
                     u
1983

-------
Chapter Seven
Elements of a Violation:   Administrative
                            Section  12(a)(2)(I)

  A person violated an order issued under  Section 13.
     ELEMENTS OF THE VIOLATION
       ESTABLISHING THE VIOLATION
1.  Determination that the person
    who owns, controls, or has
    custody of a pesticide or
    device has violated the terms
    of a stop sale, use, or
    removal order (SSURO) in that
    any person having received the
    SSURO may not sell, use, or
    remove the pesticide or device
  1.  Consult the order  to  determine
      the terms and  conditions  of the
      order.  Verify that the order has
      not been vacated but  is still
      valid.  Review Inspection docu-
      mentation to determine whether
      the pesticide  or device was
      distributed in commerce.   See
      "Additional Sources of
      Documentation" (Chapter 4).
FIFRA Gcmpllance/Biforceaent
7-34
Guidance *«««"• t 1983

-------
 Chapter Seven
 Elements  of a Violation:  Adolnlstratlve
                            Section 12(a)(2)(J)
 A person violated a suspension order Issued under Section 6.
      ELEMENTS OF THE VIOLATION
        ESTABLISHING THE VIOLATION
    Determination that:the product
    has  had  its  registration
    suspended  by order of the
    Admlnistrator.
2.  Respondent  (person) distri-
    buted,  sold,  offered for sale,
    held  for  sale,  shipped,
 .   received  and  .(having so
    received) delivered or offered
    to deliver  a  pesticide in
    violation of  the  suspension
    order.

3.  Determination as  to whether
    existing  stocks of the product
    may be  distributed in commerce.
   1.
  2.
Appropriate PTSCMS  and/or  RD
personnel advise  regional  staff
of order.  (Notice  of  Suspension
published in Federal Register;
also on file with RD.)

Identification of the  responsible
party for suspected violation in
commerce.  See "Additional
Sources of Documentation"
(Chapter 4).
  3.
Consult order and PTSCMS policy
guidance on case of existing
stocks, remaining uses, and time
frames for use.  For the
significance of the alleged
violation, see "Level of Action
Policy" (Chapter 3) Aid lor the
penalty amount, see Appendix 6.
FXFRA Goapllance/Eaforceaent
7-35
              Guidance Manual 1983

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Chapter  Seven
Elenents of a. Violation:   Adieiiilstrative
                            Section 12(a)(2)(K)
  A person violated  cancellation of  registration issued under Section 6.
     ELEMENTS OF  THE VIOLATION
       ESTABLISHING THE VIOLATION
    Determination  that  the  regis-
    tration of a pesticide  has
    been cancelled.
    Respondent (person) distri-
    buted, sold, offered for sale,
    held for sale, shipped,
    received and (having so
    received) delivered or offered
    to deliver a pesticide product
    whose registration has been
    cancelled.

    Determination as to whether
    existing stocks of the product
    may be distributed in commerce.
  1.
  2.
Appropriate PTSCMS  and/or RD
personnel advise regional staff
of product registration cancella-
tion.  (Published in  the Federal
Register.)

Identification of the  responsible
party for suspected violation in
commerce.  See "Additional
Sources of Documentation"
(Chapter 4).
  3.
Consult order to determine appro-
priate terms and conditions.
Check to see if there is any
PTSCMS policy guidance on use of
existing stocks and time frames
for use.  For the significance of
the alleged violations, see
"Level of Action Policy" (Chapter
5) and for the penalty amount,
see Appendix 6.
FIFRA Co«pliance/Knforceaent
7-36
              Guidance Manual 19R3

-------
Chapter Seven
Elements of a Violation:  Administrative
                         Sections 12(a)(2)(L);  7(a)
 A person violated Section 7 by falling to register his  or  her  producing
 establishments.
     ELEMENTS OP THE VIOLATION
       ESTABLISHING THE VIOLATION
    Determination that a pesticide,
    active ingredient of a pesti-
    cide, or device was produced
    (see definition, Section 2(v)
    of the Act).
    Determination that the producer
    of a pesticide, active ingredi-
    ent, or device subject to the
    Act has failed to register his
    or her production establishment.
      Appropriate regional or RD
      personnel review product labeling
      claims to determine whether the
      product is a pesticide, active
      ingredient, or device.  See
      "Further Processing of the ID
      Jacket—Enforcement Case Review"
      (Chapter 4).

      Appropriate regional or PTSCMS
      personnel determine establishment
      registration status.  For the
      significance of the alleged
      violation, see "Level of Action
      Policy" (Chapter 5) and for the
      penalty amount, see Appendix 6.
FIFBA Cbapliance/Bnfor*
                                   7-37
                                                       Guidance
                                    1983

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Chapter  Seven
El
ts of a. Violation:  Administrative
                       Sections 12(a)(2)(L); 7(c)(l)


 A person violated  Section  7  by falling to provide, in either an annual or
 Initial report,  the  types  and amounts  of pesticides or devices he or she
 Is currently producing,  has  produced during the past year, or has distri-
 buted during the past year.
     ELEMENTS OF THE VIOLATION
       ESTABLISHING THE VIOLATION
1.  Determination that producer  has
    failed to submit the required
    information or failed to submit
    the Information in a timely
    manner.
      Appropriate regional  or  PTSCMS
      personnel determine if report  was
      submitted, and  if  so, review
      initial or annual  report to
      determine whether  the required
      Information is  included  and  has
      been filed in a timely manner.
      Consult 40 C.F.R.  5167.5 for
      requirements.   For the
      significance of the violation,
      see "Level of Action Policy"
      (Chapter 5) and for the  penalty
      amount, see Appendix 6.
FIFBA Coapllance/Enforceaent
7-38
              Guidance

-------
 Chapter Seven
 Elements of a Violation:  Administrative
                       Sections 12)(a)(2)(L); 7(c)(2)


  A person violated Section 7 by falling to provide the names and addresses
  of recipients of pesticides or devices produced at his or her registered
  establishment pursuant to the Administrator's request for purposes of
  issuing a stop sale, use, or removal order pursuant to Section 13.
      ELEMENTS OF THE VIOLATION
       'ESTABLISHING THE VIOLATION
 1.   Determination that the re-
     quired information will not be
     supplied by the producer or is
     not  maintained*
   1.   Review the  request for the infor-
       mation to determine adequacy of
       notice.  For the significance of
       the  alleged violation, see "Level
       of Action Policy" (Chapter 5) and
       for  the penalty amount, see
       Appendix 6.
FIFRA Gcmpllance/Enfor
7-39
                    Guidance
1983

-------
Chapter Seven
Elements of a Violation;   .Administrative
                       Sections  12(a)(2)(M);  14(a)

  Any person who knowingly falsified all  or part  of any:

    •  Application for registration (40 C.F.R.  Part 162);
    •  Application for an experimental use permit (40 C.F.R.  Part 172);
    •  Information submitted under Section 7  (40  C.F.R.  Part  167);
    •  Information marked as confidential and submitted under any
       provision of the Act;
    •  Records required to be maintained  by Section 8 (40  C.F.R.  Part
       169);
    •  Records, reports, or invoices required by  40 C.F.R.
       Sl71.11(c)(7); or
    •  Reports required to be filed by the Act.
     ELEMENTS OF THE VIOLATION
       ESTABLISHING THE VIOLATION
1.  Determination that required
    information has been falsified.
  1.  Review the data submitted  to meet
      regulatory requirements.   Compare
      with records obtained during the
      Inspection of the facility to
      determine whether discrepancies
      exist.  For the significance of
      the violation, see  "Level  of
      Action Policy" (Chapter 5) and
      for the penalty amount, see
      Appendix 6.
FIFRA Compliance/Enforcement
7-40
Guidance Manual 1983

-------
 Chapter Seven
El
                                         ts of a Violation;  Administrative
                            Section 12(a)(2)(H)
      person who failed, in his or her capacity as a registrant,
 wholesaler, dealer, retailer, or other distributor, to file reports
 required by the Act.
      ELEMENTS,.OF -T™ VIOLATION
       ESTABLISHING THE VIOLATION
1.  Determination of person's
    status and failure to file
    required report.
                                the
  1.  Consult applicable regulation  to
      determine reporting requirements.
      For the significance of  the vio-
      lation, see "Level of Action
      Policy" (Chapter 5) and  for the
      penalty amount, see Appendix 6.
FIFRA
7-41
                                                       Guidance Manual 1983

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Chapter Seven
                               EL
ts of a Violation:  Administrative
                            Section  12(a)(2)(0)
 Any person who added a substance  to,  or  took a substance from, a pesti-
 cide in a manner that may defeat  the  purpose of the  Act.
     ELEMENTS OF THE VIOLATION
                                      ESTABLISHING THE VIOLATION
1.
Determination that the product
is a pesticide.
2.
Determination that a person
altered the composition of a
pesticide in order to defeat
the purpose of the Act.
Appropriate regional or RD per-
sonnel review product labeling
claims to determine whether  the
product is a pesticide.   See
"Further Processing of the ID
Jacket—Enforcement Case  Review"
(Chapter 4).

Appropriate regional or RD
personnel review laboratory  tests
to determine whether the
pesticide has been altered.  See
"Scientific Review" under
"Initial Review of the ID Jacket"
(Chapter 4) and "Laboratory  Test
Results" under "Further
Processing of the ID Jacket—
Enforcement Case Review"  (Chapter
4).  For the significance of the
alleged violation, see "Level of
Action Policy" (Chapter 5) and
for the penalty amount, see
Appendix 6.
IXFEA Compliance/Enforcewent
                               7-42
                       Manual 1983

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Chapter  Seven
El'
ts of a Violation:  Administrative
                              Section 12(a)(P)
 Any person who  used a pesticide in tests on human beings in violation of
 conditions specified by the Act.
     ELEMENTS  OF THE VIOLATION
       ESTABLISHING THE VIOLATION
1.  Determination that the test
    subject was  not fully Informed
    of:

    •  The nature and purpose of
       the test;  and

    •  Any foreseeable physical
       and /mental ^*»ai »h -f^Tiao—
       quences.

2.  Determination that the test
    subject did  not freely
    volunteer  to  participate In the
    test.
  1.
Conduct Investigation,  then
interview test subject.  Review
testing agreement to determine
the degree of disclosure made to
the test subject concerning  the
risks of the test.
  2.
Interview test subject*  Review
scientific review of the test to
verify nature and purpose of
test.  For the significance of
the alleged violation, see "Level
of Action Policy" (Chapter 5) and
for the penalty amount, see
Appendix 6.
FIFHA Compliance/Enfo:
7-43
ui
                              1983

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Chapter Seven	Elements of a Violation;
     uDapjuLonce/fioxorceaent              7—44         r^i-t^^^ ifamuii 1953

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Chapter  Seven
3     Complaint  Preparation  and  Filing
 Civil Penalty Complaint Criteria
As was previously discussed in .Chapter Five, a civil penalty action is
warranted when the "violation presents a real (but not an extreme and
unreasonable) risk to humans or  the environment; is likely to  be an
Isolated occurrence; is apparently the result of ordinary negligence,
inadvertence, or mistake; and either:

     •  Involves a first offense under the Act by any registrant,
        commercial applicator, "for-hire" applicator, wholesaler, dealer,
        retailer, or other distributor (no prior warning is required by the
        Act); or

     •  Involves a private applicator or other person (other than any party
        specified above), who has received a prior warning or  citation for
        a :'vlolatlon :of the~ Act.  (The. 'prior MBI iritig ox cfl-t8t"icT Bay shave
        been for the same or a different FIFRA violation.)

Issuance of a complaint initiates a FIFRA Section 14(a) administrative
penalty action.*


Involvement of Multiple Respondents in a Single Violation

2ntqaan£ly~,. the distribution of ;pe»ticldg» or devices In commerce will
involve more than one party before the product is ultimately purchased for
use.  These multiple-party relationships are known as "distribution
chains."  Some examples of distribution chains Include:

     •  A distributor who is also the registrant of a pesticide and the
        company that produces the pesticide for this distributor/
* The complaint also serves  to satisfy the notice and opportunity to be
  heard requirement for those actions subject to Section 9(c)(l) of FIFRA.
FIFBA Gbmpllance/Bnforcement           7-45           Guidance Manual 1983

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Chapter Seven	                    Complaint  Preparation and Filing
     •  A producer who holds a registration for a pesticide  and  a retailer
        who sells the producer/registrant's pesticide.

Under certain circumstances, more than one party in a distribution chain
may be legally responsible for the same product violation.   Pesticide
enforcement officials may cite multiple respondents in  administrative  cases
for an identical violation where it is determined that:

     •  The distributor/registrant and/or producer has  no mechanism and has
        made no effort to determine the reliability of  its supplier or
        packager;

     •  The violative product bears the name of a registered distributor
        even when no physical contribution was made to  a processing or
        packaging error and there was no knowledge of the violation; or

     •  The violative product bears the name of a distributor who is not
        the distributor/registrant but whose name provides a basis for
        consumer reliance.

Nonregistered retailers (functioning as "mere conduits'*  standing next  to
the ultimate consumer in the chain of distribution) may, at  the
complainant's discretion, be spared a civil penalty action in favor of a
Section 9(c)(3) notice of warning or an enforcement correspondence if:

     •  The violative product does not bear the retailer's name; or

     •  The violative product bears the retailer's name  but  the  name does
        not provide the basis for consumer reliance.

A producer who is not a registrant but who functions as  an agent of the
registrant, and whose liability is based solely on the  legal relation  with
the registrant may, at the complainant's discretion be  similarly treated.

In the case of a single violation involving multiple respondents from
multiple Regions, designation of regional jurisdiction  over  the  cases  or
consolidation of cases thus arising will be determined Jointly by the
Involved Regions and Headquarters PTSCMS on a case-by-case basis.
Delegated Authority
Regional Administrator

The Regional Administrator is to exercise all powers and duties  as
prescribed or delegated under the Act and the CROP.  In addition, the
                                         7—Afi

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Chapter Seven
                                            Complaint Preparation and Filing
Regional Administrator*  has been delegated the authority to:

     •  Issue  administrative complaints;

     •  Evaluate  the  appropriateness  of civil penalties; and

     •  Negotiate and sign consent  agreements memorializing settlements
        between the Agency and  respondent prior to the alleged violator's
        filing of an  answer or  failure to file an answer to a complaint.

      , The Regional  Administrator, however, must consult with the Regional
        Counsel's office before exercising any of the above authorities.
        In addition,  the Regional Administrator must consult (verbally or
        in writing) with Headquarters PTSQiS In the following instances:

        -  Routine misuse cases (verbal) ,
        -  Exceptional misuse cases of first Impression or of unusual
           national Importance  (written), and
                                  of more  -than 40 percent of .the .penalty
                  ^originally proposed  (written) .

In every proceeding,  the Regional Administrator  will rule on all motions
filed or made before  an answer  to the  complaint  is filed.  22.16(c)


Regional Judicial  Officer

A Regional Administrator may delegate  all or part of his or her authority
to act in a given  proceeding to a Regional Judicial Officer.  Any such
delegation is to be performed In accordance with the CROP.

A- flfgf ••MI T"^M >*'*al Qff'lTmr~ if^y ••*|TH>rc'l>y- r^ny • anthffT"? **y ri^'^Fflt'pd to him o
her by the Regional Administrator, or  the Regional Judicial Officer may
refer any case or motion to the Regional Administrator when such referral
is appropriate.  22.04(b)(3)
* The Assistant Administrator for Pesticides  and Toxic Substances may also
  exercise these authorities In multi-regional  cases  or cases of national
  significance.  However, he or she must consult In advance with the
  Associate Administrator for OLEC or his or  her designee and must notify
  any affected Regional Administrators or their designees when exercising

      Division "Director level.
                                                                        1983

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Chapter Seven	     	Complaint Preparation and Filing
Presiding Officer

The Presiding Officer is to conduct a fair and impartial proceeding,  ensure
that the facts are fully elicited, adjudicate all issues, and avoid delay.
The Presiding Officer has the authority, under 22.04(c), to:

     •  Conduct administrative hearings under these rules of practice;

     •  Rule upon motions, requests, and offers of proof; dispose of
        procedural requests; and issue all necessary orders;

     •  Administer oaths and affirmations and take affidavits;

     •  Examine witnesses and receive documentary or other evidence;

     •  For good cause, upon motion by a party or sua sponte (i.e., upon
        his own motion), order a party or an officer or agent thereof to
        produce testimony, documents, or other nonprivileged evidence and,
        failing the production thereof without good cause being shown,
        draw adverse Inferences against that party;

     •  Admit or exclude evidence;

     •  Hear and decide questions of facts, law, or discretion;

     •  Require parties to attend conferences for the settlement or
        simplification of the Issues, or the expedition of the proceedings;
        and

     •  Do all other acts and take all measures necessary for the
        maintenance of order and for the efficient, fair, and Impartial
        adjudication of Issues arising In proceedings governed by the CROP*
FIFRA Penalty Assessment Considerations
Factors for Determining Penalty Amount

Section 14(a)(4) of FIFRA requires that the Agency consider the following
factors In determining the initial penalty amount.  Information impacting
on this determination may be obtained from financial reports (e.g., Dun and
Bradstreet), corporate reports, and reports filed with other government
agencies such as the Securities and Exchange Commission.

     •  The Size of the Business of the Person Charged.  As applied to
        violators subject to Section I4(a)(l) of the Act and "for hire"
        applicators under Section 14(a)(2), size of business should be
        interpreted to Include total business revenues from total business
        operations of the business entity to which that product in
        violation is attributable.
                                         7—48          Guidance pfr11***' 1983

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Chapter Seven	Complaint Preparation and Filing
        Where a subsidiary company  is validly separable as an entity
        discrete from its parent, it should  be considered alone.   Where
        pesticide production is a constituent part  of a total business
        operation involving numerous nonpesticide products, size  of
        business shall be based on  total  revenues.   This determination
        should be based on acceptable accounting procedures.

        The proportion of the pesticide's component to the total
        diversified activities of the respondent, profit versus loss, etc.,
        may be considered for purposes of mitigation, but should  not be
        .entered at the outset when  initial penalty  assessment is  determined
        based on consideration of the size of the business.

        The Effect on the Defendant's Ability To Continue in Business.
        Should there be evidence at the outset that the proposed  penalty
        will affect the respondent's ability to continue in business, the
        Initial assessment should reflect this consideration and  such
        mitigation as is appropriate.

        Should it be clear at the outset  that the respondent will be unable
        to pay the proposed penalty (evidence of bankruptcy or busines
        loss available in rare circumstances when the violation is
        discovered), a penalty complaint  should be  filed nonetheless noting
        the absence of any assessment based  on inability to pay and follow
        through to an appropriate final order. In  such case, respondent
        retains the right to contest such complaint and allegation of
        violation.  (In no other situation should "zero" penalty  occur.)

        In the absence of information about  respondent's inability to pay,
        the initial presumption will be that the assessment of the proposed
        .penalty
        In no case should a threat by respondent  to go  out  of  business
        voluntarily if a penalty is assessed be considered  as  evidence of
        inability to pay.

        The Gravity of the Violation.  The gravity of any violation is a
        function of the following factors [see Amvac Chemical  Corporation
               Ho. 1I-4C<1974) j:
           The potential to injure humans or the environment,
           The severity of the potential injury,
           The scale and type of product use anticipated,
           The identity of the persons exposed to  the  risk of  injury,
           The extent to which the applicable provisions of  the Act were in
           fact violated,
           -3hB 'TJirl j^fTT^f ^*^fftin y -*¥f ' fwrfy'i^*'rtvf aTM^ actual •IcBovledse -iff
           Act, and
           Any evidence of good faith.
      cpap 11 ance/mrorL* mt1 nt              /-*»>           Guidance Manual

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Chapter Seven                              Complaint  Fr*9*ration and Filing
History of compliance and good faith may be considered  to include activi-
ties under FIFRA as amended in 1972, 1975, 1978,  and  under the 1947 FIFRA,
provided that such history does not include any complaint or notice to
which respondent made answer or explanation and which was not further pur-
sued by the complainant  [see In Re Beaulieu I.F.&R. No.  IX-10C(1974)].  A
prior notice without any further action may be considered by the complai-
nant in determining the issue of respondent's prior knowledge of the Act.


Penalty Assessment Guidelines

EPA has established a penalty assessment system that  initially assesses a
penalty amount based on the nature and extent of  the  violation and then
adjusts this amount in consideration of mitigating or exacerbating fac-
tors.  The guidelines for assessing civil penalties are  provided in
Appendix 6 of this manual.


Independently Assessible Charges

A separate civil penalty should be assessed for each  violation of the Act
that results from an independent act (or failure  to act) by the respondent
and is substantially distinguishable from any other charge in the complaint
for which a civil penalty is to be assessed.  A given charge is independent
of, and substantially distinguishable from, any other charge when it
requires an element of proof not needed by the others.   (See Elements of a
Violation:  Administrative in Section 2 of this chapter.)  Mot every charge
that appears in a complaint can be separately assessed.   Where a charge
derives primarily from or merely restates another charge, a separate
assessment is not warranted.  Charges that do not support a separate
assessment are to be indicated in the complaint as "lesser included
charges."*


Multiple Misbranding

Multiple instances of pesticide and device misbranding,  however, are not
independently assessible when there is a shipment of  a single pesticide
   See In the Matter of Pearson & Company, I.D. Nos. 88176, 88468,  90943,
   Initial Decision by ALJ Bernard D. Levinson, May 31,  1974; and In Ret
   Chapman Chemical Company, I.D. No. 104559, amended Final Order by R. A,
   Jack E. Ravan, July 29, 1975.  See also Blockburger v. United States,
   284 U.S. 299 (1932); and Tesciona v. Hunter, 151 F.2d 589  (10th  dr.
   1945).                   	
FIFRA Compliance/Enforcement             7-50          Cnida*"^ Manual  1983

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Chapter  Seven                               Complaint Preparation and Filing



product.*  Multiple  misbrandings  must  appear either:

     •   As lesser  included charges  to  accompany a count of misbranding;  or

     •   As allegations  in a single  count.

In either case, only a  single  civil penalty should be assessed.   The
gravity  of the single violation involving  several label deficiencies,
however, may be determined to  be  greater than that of a violation involving
only one misbranding.  Thus it may  support a higher penalty than that
proposed for ^single misbranding,   A  proposed penalty may be derived by
locating on the penalty matrix a  figure  for one of the misbranding
violations and increasing that figure  up to as much as $5,000.  The
Increase would depend on  the number and/or seriousness of the additional
misbrandings, as well as  whether  they  are  cited as primary or lesser
included charges.
-•';.C
   plaint Preparation
Since the complaint Initiates an administrative civil  penalty action and  is
the focal point for all subsequent proceedings, it must  be  as complete  as
possible.  Failure to file  a complaint  that meets  the  standards  and  proce-
dures outlined in this chapter may:

     •  Cause a delay in  the proceedings;

     •  Prevent the complainant from being granted a motion for  default
        under Section 22.17 of the CROP; and

     •  Make the complainant subject to adverse motions  by  other parties  to
        the proceedings.


Checklist of Complaint Requirements 22»14(a)  **

The following elements are  considered necessary to establish the legal
     1.  Statement reciting the section(s) of  the Act  authorizing  the
         issuance of the complaint;
*  See In the Hatter of Hawk Industries,  Inc.,  I.F.&R.  Docket  No.
   II-120-C, issued by ALJ Bernard 0. Levinson, December  21, 1976.
       goabers To the l:cft of ^ach-of 'the -following Items correspond to
   numbers In Exhibit 7-1, which shows a sample complaint.  The numbers in
   the exhibit Identify examples of each kind of Information.
FIFRA Compliance/Enforcement7-5

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Chapter Seven	Complaint Preparation and Filing
     2.  Specific reference  to each  provision of the Act and to the
         regulations that the respondent  is  alleged to have violated;

     3.  Concise statement of the factual basis  for alleging the violation;

     4.  Statement explaining the proposed penalty;

     5.  Copy of the Agency's "Guidelines for the Assessment Section 14(a);
         Citation Charges for Violations," 39 Fed. Beg. 27711 (1974);

     6.  Proposed amount of  civil penalty to be  assessed;

     7.  Notice of respondent's right  to  request a hearing on any material
         fact contained in the complaint  or  on the appropriateness of the
         amount of the proposed penalty;

     8.  Copy of the Consolidated Rules of Practice (CROP);

     9.  Notice of opportunity for an  informal settlement conference; and

    10.  Date and signature  with notation of title of a duly authorized
         official of the Agency.
Elements of the Complaint	


The discussion under each element of  the complaint gives  the purpose of the
element and in some cases the reason  for its  particular place in the
complaint.


Caption

     •  Identification of Respondents (A)»*   Respondents, or those against
        whom the complaint is filed,  are to be  accurately and Individually
        identified on the left side of the caption.

     •  Docket Number and Subjects of the Complaint  (B).   The I.F.&R.
        Docket Number and matters addressed In  the complaint are to be
        properly Identified on the right side of  the caption.  Docket
        numbers are assigned by the Regional  Hearing Clerk.   The docket
        number designates the Region  involved In  Roman  numerals followed by
        the case number (e.g., I.F.&R. Docket No. IZ-10C).   The docket
        number must be accurately reflected in  the caption,  because It Is
        the identifying number for all subsequent documents  filed in the
        proceedings.
* The letters in parentheses to the right of each element  correspond to  the
  letters in Exhibit 7-1.
FIF1A QmpHance/Enforceaent             7-52           Guidance Manual 1983,

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 Chapter Seven	           Complaint Preparation and Filing
Jurisdictional Authority (C)

The complaint must contain a statement of Jurisdictional authority that
informs  the Presiding Officer and the respondent of the statutory authority
under  which the complaint is issued.  This statement should be in the
beginning of the complaint and should be as specific and precise as
possible.
22.14(a)(l)


Factual  Allegations (D)

In  this  section of the complaint, the specific facts of a particular
violation are tied to the statute, rule, regulation, and/or order that
allegedly has been violated.

The goal of this section is to adequately Inform the Presiding Officer of
the alleged violations and to inform the respondent of the charges so that
an  adequate response can lie prepared .

Violations are identified by the particular sample (ID) number.

In  the event of a complaint containing multiple sample (ID) numbers, the
discussion of each separate sample (ID) should contain an enumeration of
the facts and circumstances of each separate violation related to that
sample.   The proposed penalty assessment should include an enumeration of
the dollar amount proposed for each violation charged with respect to that
sample or an indication that a particular charge is "lesser included" and
bears  no penalty assessment.  The factual allegations of the complaint,
including multiple samples, should be separated into paragraphs.

In -making "factual allegations , the key -word is "concise .""  *" Conciseness"
means  that all material facts necessary to establish the factual basis for
each violation are specified, while extraneous or irrelevant information is
omitted.  Although the purpose of this section is only to Inform the
respondent and Presiding Officer of the facts that the alleged violation is
based  on, all relevant facts should be included rather than risk failure to
meet the requirements set forth in the CROP.  For instance, even though the
respondent may have been present when certain facts were ascertained, those
£ac£« vxat *tlll 'to iadadsd to Jafexm tte xa*poadent «nd the Presiding
Officer  of their legal significance.
22.14
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Chapter Seven  	Complaint  Preparation and Filing



Amount of Civil Penalty and Rationale  (F, G)

This section of the complaint is intended to:

     •  Explain the reason for the proposed penalty (F)  in a manner that
        reflects the fact that the Agency has considered the penalty
        assessment factors specified by  Section  14(a)(4) of FIFKA.   Every
        detail of the Agency's reasoning process need not be reflected;
        however, the section should state that the FIFRA criteria were
        considered in assessing the penalty.  In order  to help meet the
        statutory requirement without  unnecessary elaboration, a copy of
        the Agency's policy in assessing FIFRA civil  penalties should be
        attached to the complaint; and
        22.14(a)(5)

     •  Specifically identify the proposed penalty amount (G).
        22.14
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 Chapter Seven	Co^pTa*™*- Preparation and Filing
 Service of the Complaint
 The respondent Is served with a copy of the complaint In either of the
 following manners:
 22.05(b)

      •  Personal service.  The complaint and accompanying documents are
         left with the respondent .or an . authorized representative; or

      •  Service by certified mail, return receipt requested.  The complaint
         and accompanying documents are mailed to the respondent or an
         authorized representative.


 Personal Service

 Fox personal service on an individual at. a business address, the «'"t"r1a-iTrt
 is  left 'with the respondent or a person who Is In charge of the office,
 such as an office manager, or a person who is responsible for the
 respondent's administrative affairs, such as a personal secretary.

 For personal service on a corporation, company, or association, the
 complaint is left with an officer, partner, managing or general agent, or
 any other person authorized by appointment or by Federal or State law to
 receive service of process.

 For personal service on a named Individual at a residential address, the
 complaint is left with any person of suitable age and discretion who
resides there.
 Service by Mall

 If  the complaint is addressed to an individual person, it should be mailed
 to  the last known business address by certified mail, return receipt
 requested.

             i'
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Chapter Seven	Complaint Preparation ar»d
Service Upon U.S. Government Officials  or  Agencies

Service upon an officer  or  agency of  the United States must be made by
delivering a copy of  the complaint to the  officer or agency, or in the
manner prescribed by  applicable  regulations.   If the agency is a
corporation, service  may be either personal or by certified mail directed
to an officer, partner, managing or general agent,  or any other person
authorized by appointment or law to receive service of process.
Service on State or Local Government Entities  or  Officials

Service upon a State or local unit  of government, or a State or local
officer, agency, department, corporation,  or other Instrumentality must
either be made in the manner prescribed by State  law or upon the chief
executive officer of the governmental unit or  the State or local officer.
22.05(b)(l)(iv)
Certificates of Service

Proof of service must be made either  by  a  properly executed affidavit of
service (Exhibit 7-3) for personal  service,  or  by a properly executed
return receipt, for service by mail.  A  certificate of service must be
filed with the original complaint.
22.05(b)(l)(v)
Filing the Complaint	


The original and one copy of the  complaint  (with proof  of service) must be
filed with the Regional Hearing Clerk.
22.05UX1)
FIFRA map 11 rrnrr/rnfnrcracnt             7-56           Guidance !*«"""»'  1983

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Chapter  Seven
                                                Exhibit 7-1
                               Sample Complaint
                                 UNITED STATES
                        ENVIRONMENTAL PROTECTION AGENCY
                            BEFORE THE ADMINISTRATOR
    In  re:
(A)
   Firetog  Industries,  Inc.
   36 Sunshine Drive,
   Clark, MA 02856

             Respondent
I.F.&R. Docket No. 1-420C   (B)
                                   COMPLAINT
                                      AND
                             NOTICE OF OPPORTUNITY
                                  FOR HEARING
                                   COMPLAINT
                                                                        (C)

   This civil  penalty  action Is  Instituted pursuant to the authority vested
   in the Administrator  of  the United  States Environmental Protection
   Agency by Section 14  [7  U.S.C.  §1361]  of the Federal Insecticide,
   Fungicide,  and Rodenticide Act, as  amended (hereinafter referred to as
   FIFRA).  The  complainant in this action is John Doe, Division Director,
   Enforcement Division, Region  I, United States Environmental Protection
   Agency, who has  been  duly authorized to institute this action.  The
   respondent  in this  action is  Firetog Industries, Inc.


                          Allegations or Counts                         (D)

   This Is to  notify you that there is reason to believe respondent has
   violated Section 12 [7 U.S.C. S136J]  of FIFRA.  The pesticide listed
   below is not  in  compliance with provisions of FIFRA as specified.

                                                                        (B)

   I.D. No. 152049  - MOLD STOP (EPA Registration No. 3681-3),  which
   was being held for  sale  or distribution by your establishment in dark,
   Massachusetts, on January 29, 1983, was:

               1.  Misbranded In  that the  label stated, in part:

                                    "*  * *
                                     MOLD
                                     STOP
                                     *  * *
                  ACTIVE INGREDIENTS:   25Z Propionic Acid
                                     *  * *-
FIFRA Compliance/&xforceaent
                         7-57
                            1983

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Chapter Seven	  Exhibit 7-1
      whereas, when tested, the product did not  contain 25Z Propionlc Acid.
      [PIFRA Sl2(a)(l)(E), 7 U.S.C. S136J(a)(l)(E);  FIFRA S2(q)(l)(A), 7
      U.S.C. Sl36(q)(l)(A)J

  2.  Adulterated in that Its strength or purity fell  below the professed
      standard or quality under which It was being held for sale.  [FIFRA
      §12(a)(l)(E), 7 U.S.C. §136j(a)(l)(E); FIFRA S2(c)(l), 7 U.S.C.
      Sl36(c)(l)]

      (When analyzed, the product was found to contain only 13.812 and
      14.232 Propionic Acid in two separate tests.)


                         Proposed Civil Penalty                         (F)

    In arriving at the assessment of the penalty specified below, the
    Environmental Protection Agency, as required by  Section 14(a)(4)  of
    FIFRA [7 U.S.C. $1361(a)(4)], has taken into consideration the
    following factors concerning the respondent:

      •  The size of respondent's business;

      •  The respondent's ability to continue in business, in light of the
         proposed penalty; and

      •  The gravity of the alleged violation.
    Agency policy with respect to assessment  is governed by the Environ-
    mental Protection Agency's "Guidelines for the Assessment Section
    14(a); Citation Charges for Violations"  [39 Fed.  Beg. 27711 (1974)], a
    copy of which is attached to this complaint.

                                                                        (6)
    Based on the above considerations, the Environmental Protection Agency
    proposes to assess a civil penalty in the amount  of  three thousand,
    seven hundred and forty dollars ($3,740) against  Firetog Industries,
    Inc.
               Notice of Opportunity To Request a Hearing               (H)

    This administrative civil penalty proceeding will  be conducted pursuant
    to the Consolidated Rules of Practice (CROP) [40 C.F.R.  122.01 et
    seq. 1, a copy of which accompanies this complaint. Pursuant  to~"the
    CROP, you have the right to request a hearing to contest any  factual
    allegation set forth in the complaint or the appropriateness  of the
    proposed penalty.  In the event that you wish to request a hearing  and
    to avoid having the above penalty assessed without further proceedings,
    you must file a written answer to this complaint with  the Regional
    Bearing Clerk, United States Environmental Protection  Agency, Region  1,
    John F. Kennedy Federal Buldling, Boston, Massachusetts  02203.
FIFRA Compliance/Enforcement             7-58           0^14^** Manual  1983

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 Chapter  Seven  	              Exhibit 7-1
     If  you do  not request a hearing or file a written answer within twenty
     (20)  days  of  receipt of this complaint, the above penalty will be
     assessed without further proceedings, and you will be so notified.
                             Settlement Conference                      (I)

     The Environmental Protection Agency encourages all parties against whom
     a  civil  penalty is proposed to pursue the possibility of settlement as
     a  xesult of  informal conferences.   Therefore, whether or not you
     request  a hearing, you may confer  Informally with the Agency concerning
     (1) whether  the alleged violation  In fact occurred as set forth above,
     or (2) the appropriateness of the  proposed penalty in relation to the
     size of  your business, the gravity of the violation, and the effect of
     the proposed penalty on your ability to continue in business.  The
     request  for  an  Informal conference does not stay the running of the
     twenty (20)  day time period for requesting a hearing and filing an
     answer.  To  explore the possibility of settlement In this matter,
    contact "Jtev-aKfttie 4Smitn, Enforcement ^Division, United States
     Environmental Protection Agency, Region 1, John F. Kennedy Federal
     Building, Boston Massachusetts 02203, telephone (312) 989-9876.
 0.                                                                     (J)
                                            John Doe
                                            Director, Enforcement Division
                                           Jfete:
                   Charges  for Violations
                 Consolidated Rules  of  Practice (CROP)
FIFRA Compllance/Enforceaent              7-59           Guidance timrnal  1983

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Chapter Seven	Exhibit 7-2


                                    Cover Letter
                                UNITED STATES
                       ENVIRONMENTAL PROTECTION AGENCY
                                  Region I
                      John F. Kennedy Federal  Building
                              Boston, MA  02203
    CERTIFIED MAIL
    RETURN RECEIPT REQUESTED

    6.B. Stubbs, Registered Agent
    Firetog Industries, Inc.
    36 Sunshine Drive,
    Clark, MA  02856

    Dear Mr. Stubbs:

    As the enclosed complaint and notice of opportunity for hearing
    indicates, the United States Environmental  Protection Agency has
    initiated an administrative civil penalty proceeding against Firetog
    Industries, Inc., for violations of the Federal  Insecticide, Fungicide,
    and Rodenticide Act, as amended (7 U.S.C. S136 et seq.)«

    It is suggested that you carefully read and analyze the complaint and
    the enclosed Consolidated Rules of Practice (40  C.F.R. 522.01 et seq.)
    so that you are fully apprised of the alternatives  offered  to you in
    considering the alleged violation, proposed penalty,  and opportunity
    for a hearing.  You will note that you have only twenty (20) days from
    your receipt of this notice within which to file an answer  to the
    enclosed complaint with the Regional Hearing Clerk, United  States
    Environmental Protection Agency, Region 1,  John  F.  Kennedy  Federal
    Building, Boston, Massachusetts 02203.  Failure  to  file a timely
    answer, in writing, will result in a default order  being entered
%
    against you for the full amount of the assessed penalty.

    The Agency encourages all parties against whom a civil penalty
    proceeding has been Initiated to pursue the possibility of  settlement
    through Informal conferences with the Agency.  Therefore, regardless of
    whether you request a hearing, you are extended the  opportunity to
    request an Informal settlement conference.  To request a conference,
    please write to Ms. Kate Smith, United States Environmental Protection
    Agency, Region 1, John F. Kennedy Federal Building,  Boston,
    Massachusetts 02203, or telephone Ms. Smith at (312) 989-9876.  Any
    discussion you may have with Ms. Smith will not affect the  time period
    in which you are permitted to request a hearing or file an  answer to
    the complaint.

                                            Sincerely,
                                            John Doe
    Enclosure                               Director, Enforcement Division
FIFBA Coapllaffice/Eflforcaasnt             7—60           c*t4A*mc<* ttan^mt  1983

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Chapter  Seven	__	Kadhlblt 7-3


                          Model Affidavit of Service
                             AFFIDAVIT OF SERVICE
                           UNITED STATES OF AMERICA
                UNITED STATES  ENVIROHMENTAL PROTECTION AGENCY

  I hereby certify  that being  a  person over 18 years  of age, I served a
  copy of the within  complaint

  (check one) ( ) In  person
              ( ) by  registered  mall,  return receipt  requested
              ( ) by  leaving the copy at principal place of business,
                  which is
               (  )  (write  in other method,  such as  leaving it at dwelling,
                   serving registered agent of  corporation, etc.)


  on the person  named  in  the complaint  on  (month,  day,  and year)*
                                      (Signature  of  person making service)
                                     Qteme t>f person making 'service)
                                      (Title,  if  any)
FIFKA Cbmpliance/EnforceBent              7-61         Guidance M«r«aT  1933

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 Chapter Seven	       Exhibits
FIFRA

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 Chapter Seven
4     Prehearing  Stage
 Intervenors and Amlcus Curiae
An individual my sake a notion to become an intervenor In any proceeding
conducted  under the CROP*  To Intervene,  the Individual's motion must
reflect  that:

      •   The individual has a certain interest in  the proceeding that is not
         adequately represented by the original parties;

      •   The Individual's presence will not unduly prolong or otherwise
         prejudice the adjudication of original parties' rights; and

      •   The individual will be affected adversely by a final order.
A motion to become ^n Imtervenor Is ordl-narily^ade before the first
TJTeheartng conference,  guwever, the ^motion may be made after that time if
good cause is shown for the failure to  file  in a timely manner.  A party
objecting to the intervention may make  an  answer to the motion to intervene
within  10 days following service of the motion.  Once an individual is
permitted to intervene, that individual becomes a full party to the
proceeding.
22.11(a), 22.ll(b), 22.11(c>, 22.03(a)
must  Identify the Interest of the applicant and the desirability of the
proposed amlcus brief.  If the motion  is granted, the Agency official
granting the motion specifies the time for filing the brief.  Once the
notion is granted, the individual, while not considered a full party, is
permitted to file amlcus briefs in all subsequent briefings during the
proceeding and is served with copies of all documents relating to such
22-ll
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Chapter Seven                                               pr»iM»aT-<«  stae
Agency Files
The Agency must maintain at least two files — one  that  is initiated by the
Regional Hearing Clerk and one that is initiated  by the Presiding Officer
upon assignment to a case.  In addition, an  enforcement official bringing
the action must maintain a separate file with duplicates of all documents
filed in the proceeding.  (See Regional Pesticides  Enforcement Case File in
this section.)
22.05(a)(l), 22.05(a)(2)

If the action is initiated at the national instead  of  the regional level,
certain terms should be substituted for the  terms set  forth below.  (See
Regional Versus National Actions in Section  1 of  this  chapter.)


Files of Regional Hearing Clerk and Presiding Officer

All substantive documents served in the proceeding  must be filed with the
Regional Hearing Clerk.  The Regional Hearing Clerk initiates this file
after receiving the original and one copy of the  complaint and the
accompanying certificate of service.  All original  copies of filings and
communications from Agency officials, including those  from the Presiding
Officer, are to be maintained in the Regional Hearing  Clerk's file.

The Presiding Officer's file contains copies of all correspondence, except
for correspondence from the parties jo the Presiding Officer.  Originals of
such correspondence are kept by the Presiding Officer.

The documents that are filed with the Regional Hearing Clerk include:
22.05(a)

     •  Original and one copy of the complaint;

     •  Originals and copies of certificates of service;

     •  Original filings of any intervenors;

     •  Original answer received from the respondent;

     •  Original and one copy of rulings, orders, decisions, and other
        documents that are issued by the Regional Administrator, Regional
        Judicial Officer, or Presiding Officer;
        22.06

     •  Originals of direct correspondence from the Presiding Officer jto
        the parties; and

     •  Copies of direct correspondence from the  parties to the Presiding
        Officer.
                 gnxorrciac me              /~OH          Guidance

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 Chapter  Seven                                               Prp***"*-rlng Stage
 Copies of  the  above  documents  oust be maintained In the Presiding Officer's
 file, except for  correspondence from the parties to the Presiding Officer.
 The originals  of  such correspondence are kept by "tEe Presiding Officer.


 Regional Pesticides  Enforcement Case File

 The Agency enforcement official initiating a complaint maintains a separate
 file containing duplicates of  all documents filed in the proceeding, as
 well as other  enforcement documents relating to the case.  Documents in
 this file  include:

      •  Copies of all documents filed with the Regional Hearing Clerk or
         Presiding Officer;

      •  Any internal EPA documents used in generating the enforcement
         action (e.g., concurrence documents, checklists, etc.);

      •  EPA investigative records such as laboratory reports and copies of
         business records;

      •  Original Penalty Assessment Worksheet(s);

      •  All correspondence between the respondent and other EPA parties;
         and

      •  All correspondence between EPA and other Federal or State agencies
         (e.g., the Department of  Justice).

 This file shall be retained for a minimum of five years in the Region after
 termination of the case,  after  which time it should be transferred to
?Jtecords Control Center.
 Filing Requirements

 A document is considered sufficient for filing  if:

      •  It contains, on the first page of the document, a  caption  that
         Identifies the respondent and the docket number assigned for the
         It bears the signature of the filing party, counsel, or other
         representative (except for exhibits); and
         22.05(e)(3)
      •  It tears *frg pane, g^drfp,, a"d. '•plephmff ""iit^tr -gf the
                                                                 by
         person.  Any changes in this information must be sent  to the
         Hearing Clerk, Presiding Officer, and all other parties to the
 F1KKA OoBpliance/Enr'orce.ent             7^55          MA^- Manual 1983

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Chapter Seven          	Pr»frear*"g Stage
        proceeding.  If a party fails to provide or, when appropriate,
        amend this information, the right to notice and  service  is  waived.
        22.05(c)(4)

The Agency official with Jurisdiction over the proceeding may prescribe
additional requirements for the form of documents.
22.05(c)(l)

If the applicable requirements are not met, the Agency official  receiving
the filing may refuse to accept it until it is properly  amended.  Permis-
sion to amend is granted only upon motion to the Administrator,  Regional
Administrator, or Presiding Officer who refused to file  the defective
document.
22.05(c)(5)

Also, any party filing a document after the complaint  has been issued must
certify that copies of the document have been sent to  other parties,
appropriate Agency officials, and any amlcus curiae.   While the  CROP  do not
give explicit sanctions for failure to provide an appropriate certificate
of service, failure to serve copies of documents on individuals  who have a
right to notice may delay the proceeding and, In some  cases, may even
result In an otherwise entirely correct proceeding being dismissed  by the
Presiding Officer or being overturned on appeal.
22.05(a)(2)
Public Access to Documents Filed

Subject to any confidentiality requirements  specified by law,  the documents
filed in the proceeding must be made available  by the Regional Hearing
Clerk for public inspection during business  hours.
22.09U)
Prohibition of Ex Parte Discussion
After a complaint has been issued, certain Agency officials  are prohibited
from discussing ex parte (i.e., without notice to all  parties)  the merits
of the proceeding with Individuals or their representatives  who have an
Interest In the proceeding.
22.08

Although ex parte discussion about the merits of a proceeding Is
prohibited, If such communication occurs, it Is regarded  as  argument, and a
copy of the ex parte communication is served on all other parties In the
proceeding.  Those other parties are then afforded an  opportunity to reply.

Failure to comply with these provisions of the CROP can taint an otherwise
entirely correct proceeding and may result in Its dismissal  by  the
Presiding Officer or In the action being overturned on appeal.
                    torceaent             7-66

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 Chapter Seven	_	Prphearing Stage



 The  Agency officials subject to ex parte prohibitions are:

     •    Administrator;

     •    Regional Administrator;

     •    Judicial Officer;

     •    Regional Judicial Officer;

     •    Presiding Officer; and

     •    Any other person who is likely to advise these officials (e.g., the
         Associate Administrator for OLEC and the Assistant Administrator
         for Pesticides and Toxic Substances).

The  Agency officials listed above are prohibited from participating in ex.
parte discussions with the following Individuals:

     *   Jn Agency -jaff Icial .who<&KC£oraa.-a .prosecutorial or investigative
         function In the proceeding or a factually related proceeding;

     •   Any person outside the Agency who has an interst in the proceeding;
         and

     •   Any representative of the persons identified above.



Answer  to  the Complaint


The  respondent -gust respond to -the allegations in the complaint within 20
days after service of the complaint.*  The response is in the form of an
answer.  In the  answer, the respondent must admit, deny, or explain each of
the  factual allegations contained in the  complaint.  Where the respondent
has  no knowledge of the allegations and makes a statement to that effect,
the  allegations  are considered denied.  22*15(b)  Failure to admit, deny,
or explain any material factual allegation contained In the complaint"
constitutes an admission of that allegation.
22.15(4)


Procedural Considerations

Before  the answer Is filed, all notions are made to the Administrator or
Regional Administrator, or the Judicial Officer or Regional Judicial
* Service of the  complaint  is  complete when the  return receipt  is  signed
  (if the complaint was mailed)  or when personal service  is  effectuated.
FXrRA. Coapllance/BDZorcement             7-67           oi^^t^ Manual  1933

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Chapter Seven       	Pr»tn.pi-f^g stage
Officer, as appropriate.  After the answer  is  filed,  a Presiding Officer is
designated, and all motions are made  to  that official.
22.16(c)

Filing a timely answer precludes the  complainant  from seeking a motion for
default based on the failure to file  a timely  answer.
22.17(a)(l)

Filing a timely answer lessens complainant's opportunity to amend since, as
a matter of right, the complainant may amend the  complaint once before the
answer is filed.  Otherwise, a motion must  be  made  to and approved by the
Presiding Officer.
22.14(d)

The complainant may withdraw the complaint, all or  in part, without
prejudice one time before the answer  has been  filed.   After one withdrawal
before the filing of an answer or after  the filing  of an answer, the
complaint may be withdrawn only upon  motion granted by the Presiding
Officer or Regional Administrator.
22.14(e)


Sufficiency of Answer

The answer must meet the following requirements:

     •  Filing the original of the answer with the  Regional Hearing Clerk;
        and

     •  Complying with the general filing,  service, and content
        requirements specified by the CROP.
        22.05

The contents of the answer must include:

     •  Clear and direct admissions,  denials,  or  explanations of each
        factual allegation contained  in  the complaint of which the
        respondent has any knowledge.  If the  respondent has no knowledge
        of a particular factual allegation  and makes  a statement to that
        effect, the allegations are considered denied.  All allegations
        should be addressed in some manner;

     •  Grounds for defense;

     •  Facts that the respondent will put  in  issue;  and

     •  Any request for a hearing.
        22.15(b)
FXFiA CDBpli4a.ee/Enforceaeiit             T--68           Guidance Manual 1983

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 Chapter  Seven	Prrheiiring Stage
 Evaluation of Answer

 Upon receiving  a copy of  the answer,  the complainant should immediately
 review it for any deficiencies  and also check with the Regional Hearing
 Clerk to ensure that  the  requirements concerning timely filing and the
 general filing  requirements  have  been met.   Review of the answer might also
 indicate that a motion to amend the complaint is warranted (i.e., if
 proposed penalties  should be reduced  or increased).


 Consequences of Deficient Answer

 If the form requirements  specified by Section 22.05(c) of the CROP are not
 complied with,  the  Regional  Hearing Clerk can refuse to file the answer.
 22.05(c)(5)

 If the requirements specified by  Section 22.15(b) of the CROP are not
 complied with,  the  insufficient answer may be regarded as an admission of
 the matter(s) not  sufficiently  discussed.
 If the answer is not  filed within  the  time  requirement (20 days), the
 complainant can seek  a  default  order.
 22.17(a)(l)
 Prehearing Motions
 Motions may be made by  the  parties before  a hearing  is  convened.   Before
£be filing of an ansver^ ootionf are filed with the  Regional
j.ddaltri «trator.  After the filing of -an xncwer^ action* «*re £ll«d with
 Presiding Officer.
 22.16(c)
 Written Motions

 All motions made during  the  proceeding, except  those made orally on the
        dnxlag m- hearing «nst :
      •  Be in writing;

      •  Specifically state the grounds or basis for  the motion;

      •  Specifically identify the action(s) that  the motion  seeks;
       uoapj^ance/ioiiorceaent              7—69           aniAmn^f MMMUII  1903

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Chapter Seven
     •  Be accompanied by any evidence  that  is  being relied upon by the
        movant  (e.g., affidavits and  legal memoranda);  and

     •  Be served upon the parties.

A written motion must also comply with  the general filing and service
provisions of Section 22.05 of  the CROP (i.e.,  It must  be properly signed,
accompanied by  appropriate certificates of service, and bear an appropriate
docket number).

Since a transcript is required  only In  a hearing and may be used in
prehearing conferences at the discretion of  the Presiding Officer, most
motions made before the hearing will  probably have to be in writing and
conform with the requirements specified by Section 22.16(a) of the CROP.
22.19(c)


Reply to Motion

A party's response to any written motion must be filed  with the Regional
Hearing Clerk within 10 days after service of such motion, except in Che
case of a motion for a default  order, which  specifies a 20-day period for
replies.  Like  all documents filed in the proceeding, replies to motions
must bear the docket number and comply  with  the filing  and service
requirements specified by Section 22.05 of the  CROP.
22.16
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 Chapter  Seven  	Prehearing Stage
     •   Motion for default for failure to comply with a prehearing order of
         the  Presiding Officer;
         22.17(a)(2)

     •   Motion for default for failure to appear at a conference or hearing
         convened  by the Presiding Officer pursuant to Section 22.19 of the
         CROP;
         22.17(a)(3)

     •   Motion for consolidation or severance; and
         22.12(a), 22.12
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Chapter Seven	prphoa^tyg Stage
This time period Is 10 days longer  than  that  generally specified for
replies to motions (Section 22.16(b) of  the CROP).


Default Order as Initial Decision

A default order at the time it  is issued by the Presiding Officer (Regional
Administrator or the Regional Judicial Officer, if  a timely answer is not
filed) constitutes an initial decision of the proceeding.  As such, it
must:
22.17(b)

     •  Contain findings of fact, conclusions regarding material issues of
        lav or discretion, and  the  recommended penalty; and
        22.17(c)

     •  Be filed with the Regional  Hearing Clerk.
        22.17(b)

The Regional Hearing Clerk must serve copies  of the initial decision on all
parties to the proceeding and otherwise  comply with Section 22.27 of the
CROP, which addresses transfer  of the proceeding's  record to the Hearing
Clerk.  The default order becomes the final order of the Administrator
within 45 days after its service upon the parties unless (1) the default
order is appealed or (2) the Administrator elects,  sua sponte, to review
the default order.
Appeal

A default order may first be appealed by  a motion to  set aside the default
order made to the Agency official who issued  the  default order.  Any
further appeal of the default order must  be made  directly to the
Administrator pursuant to Section 22.30 of the  CROP.
22.17(d), 22.29(a)


Consequences of Final Default Order

When the Administrator Issues a final order upon  default against the
respondent, respondent is subject to the  following consequences:

     •  The respondent has essentially "admitted*' to  all facts alleged in
        the complaint and the right to a  hearing  is waived;  and

     •  The penalty proposed In the complaint will become due and payable
        within 60 days after the final order  is Issued.   22.17(a)

The admission of factual allegations and  waiver of hearing applies only to
the immediate civil penalty proceeding and does not affect any other
proceedings.  In addition, the 60-day period  for  payment of the penalty
begins only after the Administrator has issued  a  final order upon default,
not after the Presiding Officer Issues the initial default order.
FXFRA Compliance/Enforcement              7-72           Guidance Manual 1983

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 Chapter Seven	Prehenrlng Stage
When the Administrator issues a final order upon default against the
complainant,  the complaint is dismissed with prejudice.  If the complaint
is  dismissed  with prejudice, the complainant cannot reinstitute a civil
penalty proceeding that is based on the allegations in the dismissed
complaint.
 Settlement	


 EPA encourages  settlement of a'civil penalty proceeding, if the settlement
 is  consistent with the provisions and objectives of FIFRA and its
 applicable  regulations.
 22.18(a)
Procedures
A settlement conference can be requested at any time.  The parties may
confer  on settlement whether or not the respondent has requested a
hearing.  Before an answer is filed and a Presiding Officer is appointed,
settlement  conferences can be convened by consent of the parties.  After a
Presiding Officer has been appointed,  settlement conferences are subject to
the Jurisdiction of the Presiding Officer who may order a prehearing
conference  settlement.  As an alternative, the parties may be directed to
correspond  with the Presiding Officer  concerning settlement.
22.18,  22.19


Consent Agreement and Proposed Consent Order

If r.aa«ett lament Is reached by ^tne parties , -they ^must forward a written
consent agreement (see Exhibit 7-5) and a proposed consent order to the
Regional Administrator.  In addition,  they must serve copies of these
documents on the Presiding Officer if  one has been appointed.  The consent
agreement must  contain the following Information before the Regional
Administrator can approve it:
22.18(b)
                    e: of all .parties or tfaair representatives in the
        •proceeding  (e.g.,  complainant, respondent,  and any intervenors) ;

     •  A statement In which the  respondent admits  that the Agency has
        Jurisdlctlonal authority  to  bring the complaint;

     •  A statement In which the  respondent admits  facts stipulated In the
        consent  agreement  or neither admits nor denies facts alleged In the
        A statement  in which the  respondent  consents  to the  assessment  of
        the  stated civil penalty  that  is reflected In the consent agreement
        and  proposed consent order.
FXFKA GompJLiance/Enforcement             7—73          Guidance tlamiil  1983

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Chapter Seven         	pr»ho.^i«g stage
Also, the consent agreement must Include any and  all  terms of the agreement
among the parties.  Consequently, any terms to which  the parties have
agreed in reaching a settlement must be reflected in  the consent agreement
(e.g., agreement not to pursue criminal penalties,  agreement by intervenor
not to pursue private damage remedies, agreement  by the  respondent to taVe
actions that minimize the effect of the violation,  etc.).

Partial settlement of the proceedings is permitted  and,  in many cases, is
likely.  Settlement agreements and proposed consent orders must be very
carefully drawn and completely understood before  signatures are obtained so
that the parties understand precisely what elements of the matter are not
disposed of by the consent agreement and consent  order.

The consent agreement becomes final and binding on  the parties only after
the Regional Administrator has signed the consent order.  The consent order
disposes of only those elements of the proceeding that are specifically
addressed by that order and the consent agreement.
                        t
The proposed consent order must be prepared for the Regional
Administrator's signature.  It need not restate all the  terms of the
consent agreement, but it must at least explicitly  incorporate by reference
the consent agreement as being the basis for the  consent order.
22.18(c)

The Regional Administrator, in deciding whether to  issue a final consent
order, may require parties to the settlement to appear in person to answer
questions relating to the proposed consent agreement  or  order.


Filing of Consent Agreement and Order

The consent agreemeent and the final consent order  constitute Important
documents that affect the substantive and procedural  rights of the
parties.  Consequently, the originals of these documents must be placed in
the Regional Hearing Clerk's file, and copies must  be served as required by
Section 22.06 of the CROP.
Prehearing Conference


When a hearing is ordered, the Presiding Officer also convenes  a prehearing
conference, unless it appears unnecessary.  Prehearing  conferences  are
intended to facilitate and expedite a hearing proceeding.   These
conferences encourage informal, frank discussions among the parties on any
matter that could expedite the hearing.  Any anticipated problems should  be
discussed at this time.  The prehearing conference may  involve:
22.19(a)

     •  Settling the case;
FIFKA compliance/Bixorcement             7-74          0*1+?**•* Manual

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 Chapter Seven	         Preheating Stage
      •  Attempting to simplify the proceeding  through consolidation of
         issues and stipulation by the parties;

      •  Amending the pleadings;

      •  Exchanging information concerning evidence  to be  presented (e.g.,
         identities of expert witnesses and summaries  of their  testimony and
         exchange of exhibits, documents, and prepared testimony);

      •  Limiting the number of witnesses;

      • .-Setting a time .and place for the hearing ; and

      •  Attending to any matter that may expedite the disposition  of the
         proceeding .


 Exchange of Information

 The CROP generally require that the parties exchange  witness lists.,  brief
 descriptions of witness testimony, and copies of sll  documents and -physical
 evidence that will be Introduced into evidence.  This requirement  supports
 the accepted manner of hear ings —one that is forthright and avoids
 surprise .  22. 19(b)


 Failure To Exchange Information

 If  the party does not exchange information before the hearing and  desires
 to  introduce a document or a witness during the hearing,  that party  must
 request the permission of the Presiding Officer.  Additionally, if such
 permission is granted, the Presiding Officer must first allow .other  parties
            y •*»<*it*» -t*»-.Tyri-f»». tfag ruM^iy jpr-rf^fn^^ evidence.
 Protection of Evidence Sources

 Certain unusual circumstances may justify not following the policy of early
 information exchange.  One such example Is a reasonable belief that
 witnesses might be subject to physical or economic intimidation.  Another
 circumstance -Is .a ...reasonable ,he3 iff that -the ^nature of the documentary or
^physical evidence would perait xthe respondent £o intimidate witnesses ,
 destroy evidence, or otherwise Improperly Interfere with the enforcement
 efforts of the Agency.  In such situations, the Presiding Officer should be
 fully Informed of the reasons for withholding evidence or the Identity of a
 particular witness.


JLole «of vj&scovery

 The CROP state that evidence that is not subject to the mandatory exchange
 of  witness lists  and documents in the prehearing conference , shall be
 subject to discovery only upon determination by the Presiding Officer.
FIFKA Compliance/Boxorceaent             7-75          Guidance H"""»i 1983

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Chapter Seven  	_____	   Pr?hear*"g Stage
This provision is primarily intended to address  discovery by deposition.
To obtain such discovery, a party must make a motion  for  discovery to the
Presiding Officer, which demonstrates that the:
22.19(f)

     •  Proceeding will not be unreasonably delayed by discovery;

     •  Information sought cannot be obtained through alternative  means;
        and

     •  Information sought is of significant probative value.
        22.19(f)(l)

If the discovery involves oral depositions, then a party  must also show
that the evidence will not be preserved for presentation  by a witness.
22.19(f)(2)

The difference between evidence that is subject  to mandatory exchange
requirements and evidence that may be discovered must be  carefully
understood.  If the evidence being sought should normally be exchanged
under Section 22.19(b) and for some reason Is being withheld, then a motion
to the Presiding Officer to enforce the requirements  of the CROP must be
made, not a motion for discovery.

If an order for discovery Issued by the Presiding Officer is not obeyed,
the inference may be drawn that revealing the withheld information would
adversely affect the party withholding it.  Also, an  order for default  may
be issued based on a failure to comply with a prehearlng  or hearing order.
22.19(f)(4), 22.17(a)

An order for discovery is an Important document  that  affects the procedural
rights of the parties.  It must, therefore, be Included In the Regional
Hearing Clerk's file, and copies must be served in accordance with
requirements of Section 22.06 of the CROP.


Record of Prehearlng Conference

The record of a prehearing conference generally consists  of a summary
prepared by the Presiding Officer that Incorporates all rulings or orders
containing directions to parties and any written stipulations or agreements
of the parties.  Except for those portions of a prehearlng conference that
relate to settlements, a transcript of the prehearlng conference may be
made.  The transcript Is ordered by the Presiding Officer upon motion of a
party or sua sponte.
22.19(c)

Settlement conferences, however, are not recorded in  order to ensure that
the parties are able to negotiate freely and compromise without fear that
such agreements will be subsequently revealed.
FIFRA Coapllance/Boforcement7-76

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Chapter  Seven	PrehMring Stage
The  transcript  or  written summary of the prehearing conference must be
filed with  the  Regional Hearing Clerk for inclusion in the Regional Hearing
Clerk's  file.
22.06

If a transcript is taken, motions made during the hearing may be oral.
However,  if no  transcript is taken, any motions made must be in writing and
must otherwise  conform with the requirements of Section 22.16 of the CROP
and  the  filing, service, and content requirements specified by Section
22.05.
Motion for Accelerated Decisions and Dismissals
Motion for Accelerated Decision

The Presiding  Officer may issue an accelerated decision either sua sponte
or upon atotion ,by the respondent; ox complainant.  Hie accelerated decision
may Involve  a  particular issue or the entire case, and may be issued at any
time during  the  proceeding if the Presiding Officer finds that:
22.20

     •  No genuine issue of material fact exists between respondent and
        complainant;  and

     •  The  complainant or respondent is entitled to a judgment as a matter
        of law.   "Entitled to a judgment as a matter of law" means that the
        movant has established by undisputed or undisputable (not
        reasonably challenged) evidence that all technical and legal
       . -elements 'i& -a*viaP'iL'ytJ:PTi-'ii^i"''riffpcifT":^Bri vts^^t t 'fgom^iwtif ly t tite
        Presiding Officer vast decide a particular issue or the entire case
        in the movant's favor at that time.  Because there Is nothing to
        adjudicate, there Is no need for a hearing.

A discussion of  all of the relevant precedents and considerations that
apply to a motion for an accelerated decision is not feasible in the space
allowed.  However, some general principles can be discussed.


essential position of ~the other party's case.  The notion asserts that,
under the facts  and law of the case, the adverse party's position is
entirely without merit*  In this sense, it is not merely a technical
notion—that is, one which seeks to establish that the manner or form of
the other party's pleadings Is technically insufficient to establish A
defense or a claim.  It would not, for example, seek to establish that the
respondent's defense pleadings lack discussion of an essential element of

pleadings by demonstrating that, irrespective of those pleadings, the facts
and law of the case require a judgment in favor of the moving party.
                                          7-77

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Chapter Seven	 Prehearing Stage
Facts.  By requiring that no genuine material  Issue  of fact exists between
the parties, the standard for an accelerated decision does not mean that
the parties must agree on all material  facts.   Instead, the material facts
may be either undisputed, or undisputable,  that is,  not reasonably
challenged.

Affirmative Defenses.  The complainant  must demonstrate entitlement to a
judgment as a matter of lav.  The complainant  is required not only to prove
the elements of the violation by undisputed or undisputable evidence, but
also to address any affirmative defenses  raised by the respondent with
undisputed or undisputable evidence (e.g.,  an  argument that the respondent
relied on Agency advice in violating applicable regulations).

Evidence and Burden.  The Presiding Officer will probably rely on
affidavits and counteraffidavlts in reaching a decision on the motion for
an accelerated decision.  However, the  Presiding Officer may consider any
admissible evidence, including stipulations, admissions, expert witness
testimony, deposition testimony, and officially noticed evidence.
22.20(a)

In deciding whether to grant the motion for an accelerated decision, the
Presiding Officer generally gives the party against  whom the motion is made
every benefit of the doubt.
Motion To Dismiss

In addition to a motion for an accelerated  decision,  the respondent can
make a motion to dismiss for:

     •  Failure of the complainant  to establish a prlma facie case; and

     •  Other grounds that show that the  complainant  has no right to
        relief.  22.20(a)

To find useful precedent and argument for these standards,  the following
sources may be helpful:

     •  For the first standard, Rule 41(b)  of  the Federal Rules of Civil
        Procedure (Fed. R. Civ. P.), Involuntary Dismissals, and any
        Federal decisions on this rule; and

     •  For the second standard:

        -  Agency decisions—in which FIFRA standards for an accelerated
           decision were applied—that relate  to failure to state adequate
           claim or in which the result was required  by Justice, and
        -  Federal decisions [involving Fed. R. Civ.  P. 12(b) which relates
           to motions to dismiss] that were based on  lack of jurisdiction,
           insufficient process, or failure to state  a claim upon which
           relief can be granted.
FIFRA Caamliance/EnforceBent              7-78          Goldasee *-«""•' 1983

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 Chapter Seven	_____	Prehearlng Stage
 Partial  Decision

 A decision that grants a notion for an accelerated decision or a motion to
 dismiss  need not dispose of all issues in the proceeding.  If such a
 partial  order is issued, the Presiding Officer must also determine which
 Issues remain in controversy between the parties.  To do so, the Presiding
 Officer  must issue an interlocutory order that specifies the issues
 disposed of by the accelerated decision or dismissal order, and those
 issues that remain in controversy.
 22.20(b)(2)
 Initial  Decision
If an accelerated decision or dismissal order is issued to dispose of all
issues in  the  proceeding, such orders are treated as initial decisions and
may be appealed  to the Administrator under Section 22.30 of the CROP.
22.20(b)(l)  If  a partial decision is rendered, the objecting party, before
appealing, must  await  the issuance of a final initial decision or obtain
22.20(b)<2), 22.29

An initial decision must comply with the requirements of Section 22.27(a)
on content, filing, service,  and transfer requirements.
FIFBA rrr»pn*-              7-79

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7-80
                               1983

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 Chapter Seven
 5    Hearing  Stage
 The Presiding Officer convenes  a hearing on  request by the respondent or,
 if appropriate, sua sponte—if  the matter has not yet been disposed of by a
 default order, accelerated decision, dismissal order, or consent order.
 The Chief Administrative Lav Judge appoints  a Presiding Officer as soon as
 the respondent files an answer.
 22.21
 Notice of Hearing and Venue


 The Presiding Officer must issue  a notice of hearing to all parties,
 Identifying the time, date, and place  for the hearing, at least 20 days
 before the date set for the hearing.   22.21(b)  The hearing is generally
 held in the county, parish, or Incorporated city where the respondent
 resides unless otherwise agreed to in  writing by all parties.
 22.3X*)

 Any party may make a motion for change of venue.
 22.19(4), 22.21(d)

 In addition, a party may make a motion for postponement of the hearing but
 must demonstrate good cause for the request.
 22.21(c)
 Presentation of Evidence
 As Is true for all Agency administrative proceedings , the complainant is
 the first to present evidence.  The complainant must establish a prlma
 facie case; that is, the complainant must submit evidence that £he events
^^iJSBlBBfl' '';'«Att ~r<^iHmft :*-1^BBB
 of the Act, and that the proposed civil penalty is appropriate.  After the
 complainant has established  a prlma facie case , the respondent must then
 present any defense to the allegations that are contained in the complaint
 and any affirmative defenses that are raised by the answer.
 22.24
 FIFKA. Gompllance/biforcement            7-81          ^lijimrf Manual 1983

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Chapter Seven
                                                                     g
"Burden of Presentation" and "Burden of Persuasion" are  used  in the CROP to
describe the burden of proof that is placed on the parties  in the  hearing.
22.24  The definitions are as follows:

     •  Burden of Presentation (Burden of Going Forward  With  the
        Evidence)—A party must introduce evidence on  the  claims or
        defenses raised in the complaint or answer.

     •  Burden of Persuasion—Each party must convince the  Presiding
        Officer of the affirmative allegations In his  or her  pleading.

The complainant is alleging that a violation has in fact occurred  and,
therefore, has the burden of presentation.  The complainant also has the
burden of persuasion.  Once the complainant has established a priaa facie
case, the burden of presentation shifts to the respondent,  who must then
introduce sufficient evidence to rebut or outweigh the evidence presented
by the complainant.  The burden of persuasion never shifts, but remains
with the complainant throughout the proceeding; that Is, the  complainant
always has the obligation of convincing the Presiding  Officer, by  a
preponderance of the evidence, of the allegations contained in the
complaint.

The respondent has the burden of persuasion with respect to any affirmative
defenses raised in the answer—for example, a reliance argument based
on Agency advice.  The Burden of Presentation initially  rests with the
respondent but shifts, once the respondent has Introduced  sufficient
evidence to support a favorable finding.
Preponderance of Evidence


Each matter contested in the hearing is determined  by  the Presiding Officer
on the basis of a preponderance of the evidence.  To prevail,  a party must
convince the Presiding Officer that, on balance, his or  her allegations
appear more likely or probable than the other party's  allegations.   This
standard, is different from a criminal standard, which requires a decision
based on "evidence beyond a reasonable doubt" or "evidence excluding a
reasonable doubt."
22.24
Default Orders and Accelerated Decisions
During the hearing, the complainant should keep in mind  that  a motion for
default order (except one based on failure to file a timely answer)  or a
motion for an accelerated decision may be appropriate despite the  advanced
stage of the proceeding.
FIFSA Qmpllance/Enforceaent7-82          Goldy"*"* **•""•*  1993

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 Chapter  Seven	     Hearing Stage
 Hearing Rules of Evidence


 Under the CROP, the Presiding Officer must admit  evidence unless  it  falls
 in one of the following categories:

      •  Irrelevant;

      •  Immaterial;

      •  Unduly repetitious;

      •  Unreliable; and

      •  Of little probative value.
         22.2(a)

 When in doubt, the Presiding Officer will most likely admit, not  exclude,
 evidence.


 Confidential Information

 The CROP state that, from the outset, confidential information can be
 introduced as evidence.  The Presiding Officer may make such orders as may
 be necessary to consider such evidence in camera, including the preparation
 of a supplemental initial decision to address questions of law, fact, or
 discretion arising out of that portion of the evidence that is confidential
 or includes trade secrets.
 22.22(a)

 Bnlass otherwise petaltted by the Presiding Officer, vtich « supplemental
 decision, if issued before the final Initial decision, is to be treated
 like a partial decision and is not appealable until the final initial
 decision is issued or certification to appeal an interlocutory decision is
 obtained.
 22.29(a)

 For confidential commercial information, the complainant should be aware
      J JJ.S.C. :£19O1 prohibits ttie dJjsclosure of *uch laf oraatlon by a
           : official,.  <8ee also Chapter -Eleven.)
 Materiality and Relevancy

 Two standards described In the CROP concern materiality and relevancy.
 Materiality and relevancy are legal terns of art, and previous cases should
£• -fiounsltad to xofettex»&ne tow tbey 
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Chapter Seven          	  jt~fTing stage
     •  Materiality.  Material evidence  is  evidence that is pertinent to or
        has a legitimate and effective bearing on the case.  For example,
        the evidence relating to  the  status of an officer within a
        corporation may be material to proving that he or she knowingly
        violated FIFRA by manufacturing  a certain pesticide.  The officer's
        status within the local church,  however,  is not likely to be
        material.

     •  Relevancy.  Evidence that Is  material  may or may not be relevant.
        Relevant evidence is evidence that  has a  tendency to make a fact in
        issue more probable or less probable.   The emphasis here is on the
        probative value of the evidence. The  probative value of offered
        evidence must be assessed in  light  of  the facts in issue.  For
        example, to prove that a  reporting  violation has occurred, evidence
        demonstrating that a. particular  EPA report was prepared but not
        sent would surely be relevant.   In  contrast, evidence that the firm
        generally failed to maintain  good business records might still be
        considered material but is less  likely to be considered relevant or
        probative.

Although materiality and relevancy have  technical distinctions, in general,
both standards can be viewed in terms of probative value of evidence.  If
an item of evidence has probative value  (i.e., tends to prove or disprove a
particular proposition) to the issue  for which it is Introduced, then both
criteria are satisfied.
Evidence Relating to Settlement

Any evidence relating to settlement  that would  be  excluded under Rule 408
of the Federal Rules of Evidence  (Fed.  R.  Evid.) is  also excluded under
the CROP.  Rule 408 of the Fed. R. Evid. generally excludes evidence of
settlement or attempted settlement when it is offered as proof of an
admission of liability.  However, this  evidence may  be admitted for another
purpose, such as proving bias of  a witness or disproving a contention of
undue delay.  When such evidence  is  offered for these purposes, it may
still be excluded if the Presiding Officer determines that its probative
value is outweighed by confusion  of  Issues,  undue  delay, etc.


Testimony of Witnesses

Witnesses are generally examined  orally upon oath  or affirmation.  The
Presiding Officer, however, may allow certain exceptions to this rule
(e.g., an affidavit from a dying witness).  Any witness appearing at the
hearing may be cross-examined if  the cross-examination la not  unduly
repetitious.
22.22(b), 22.22(d)
FIFRA GMpllance/Enforeeaemt              7-84           Qaldance Kaaaal 1933

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 Chapter Seven	Hearing Stage
 Verified Statements in Lieu of Direct Testimony

 In lieu of direct testimony, a party may desire that a witness admit  Into
 the record previously prepared statements of fact or opinion.  Such a
 request may be appropriate when the testimony is technical or academic  and
 does not lend itself to a clear, cohesive presentation through direct
 questions.  This type of evidence can be admitted only upon the approval of
 the Presiding Officer.

 A copy of the written statement must be submitted to the Presiding Officer,
 reporter, and opposing counsel before It is delivered.  The evidence
 contained in the statement is subject to the same rules of testimonial
 evidence that apply to oral testimony (e.g., the witness must swear to  or
 affirm the statement and is subject to oral cross-examination concerning
 the statement).
 22.22(c)


 Affidavits in Lieu of Direct Testimony

 When a witness is "unavailable," as defined by Rule 804(a) of the Fed.  R.
 Evid., an affidavit may be admitted into evidence in lieu of oral
 testimony.  Older Rule 804(a), witnesses are deemed unavailable if they are
 exempt by a court order, refuse to testify in spite of a court order, claim
 lack of memory, are dying or physically impaired, or are absent despite
 efforts to secure their attendance.
 22.22(d)


 Exhibits and Physical Evidence
                                 original -nd one -copy-must be filed vith
 the Presiding Off leer where practicable.  A true copy of any exhibit may be
 substituted for the original if submitting the original is not possible.
 Copies must also be furnished to each party.
 22.22(e)


 Official  Notice

Tft«* 'yrrrf fllTW ft^fiTTT''SMy Ty^y ~ :fff^* r1* y^  :t*r*Tl TT '-trf sny astfrf T j^iT'f **'**^ ^y
 noticed in the Federal courts, of matters permitted under Rule 201 of the
 Fed.  R. Evld., and of other facts that are within the specialized knowledge
 and experience of the Agency.  Official notice may be sua sponte or upon
 notion by one of the parties.
 22.22(f)
                            201 ^f £he Jed. JL> ;.£vid« is \dlsd£ed Co
           thst s»e not sedbject  to Tvesonable dispute,and €hat are?
         Generally known within the territorial jurisdiction of the
         proceeding;  or
       msipiinnrr/rmrnrrrmf m             7—ay          Guidance tlsirir*1 1983

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Chapter Seven          	Hearing Stage
     •  Capable of accurate and ready determination.

"Adjudicative facts" directly concern the  Immediate parties in the
proceeding—who did what, when, where, how, and  with  what motive or
intent.  These facts relate to the occurrence(s) alleged by the pleadings,
which must be adjudicated to decide  the case.

The official notice that the Presiding Officer may employ as a result of
the special expertise of the Agency  is broader than that permitted by Rule
201 of the Fed. R. Evid.  Consequently, official notice extends to all
matters about which the Agency is presumed expert. For example, the
experience and knowledge of the Agency In  an environmental area might
justify official notice that, statistically, a physical event always occurs
under a certain set of environmental circumstances.
Objections and Rulings


Objections about the conduct of the hearing,  such as evidentiary and
procedural objections, may be stated orally or  In writing.   The form of the
objection depends on the circumstances.   In general, however, if the
objection involves a relatively complicated argument and if time permits,
it should be written.  If it is written,  it must  comply with the service,
filing, and content requirements specified  by Section 22.05 of the CROP.
22.23(a)


Rulings and Exceptions to Rulings

The Presiding Officer must rule on all objections and provide reasons for
the rulings, which will become part of the  record.  Copies  of the ruling
must be served on the parties by the Presiding  Officer and  the original
entered into the Regional Hearing Clerk's file  in accordance with Section
22.06 of the CROP.  The CROP also state that  to take specific exception to
each overruled objection is not necessary.  The exception to an overruled
objection is automatic and is not waived by further  participation in the
hearing.
22.23U)


Appeal of Ruling

A ruling on an objection is not subject to  an automatic Interlocutory
appeal to the Administrator.  A party wishing to  appeal the ruling
Immediately, must make a motion in writing  within six days  of notice of the
ruling to the Presiding Officer to certify  such a ruling to the
Administrator.  (See also "Appeals of Interlocutory  Orders  or Rulings" in
this section.)
FIFBA Compliance/Enforcement              7-86           Quida"*** Manual 1983

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 Chapter Seven	Hearing Stage
 Unlike other motions made during a hearing, a request  for  certification may
 not be made orally, but must be in writing.
 22.29'> ^•mmHW,^ .'^••MA' ^PwV^MBt^V^ '- ••^•••••^•^ <^B»^E p^bA^VAB<
        «Tsbaltte€ to the Presldl-ng 
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Chapter Seven           	Hearing Stage
Proposed Findings, Conclusions, and Orders
At the conclusion of the hearing, parties may submit  proposed findings of
fact, conclusions of law, and orders to  the  Presiding Officer for
consideration in Issuing the Initial decision.

The purpose of the proposals and supporting  briefs  is to advocate positions
of the submitting party and to persuade  the  Presiding Officer to adopt that
party's .proposals.


Procedures

The proposed findings of fact, conclusions of law,  and orders, together
with supporting briefs, may be submitted to  the  Presiding Officer for
consideration within 20 days of notice of the transcript's availability.
The proposals and briefs must be served  on the other  parties.  Although the
Presiding Officer must permit reply briefs,  the  timing of such briefs can
be specified.  The proposals and all briefs  must be in writing and must
contain adequate references to the record and authorities relied on.
22.26


Preparation

In preparing the proposals, the focus should be  on  issues that the
Presiding Officer must address in the initial decision.

The importance of the proposals and briefs cannot be  overemphasized.
Through these materials, the position of the submitting party can be
detailed, and the Presiding Officer can view in  depth the merits of the
party's position.


Initial Decision

The Presiding Officer must issue an initial  decision  as soon as is
"practicable" after the period specified for filing reply briefs to the
proposed findings, conclusions of law, and orders.

The initial decision should contain the  Presiding Officer's:

     •  Findings of fact and conclusions for all material Issues of law or
        discretion;

     •  Seasons for those findings and conclusions;

     •  Recommended civil penalty; and

     •  Proposed final order.
      uaap a T arTic**/ aazerr "sent              /—oo

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 Chapter Seven	Hearing Stage
 In determining the dollar  amount  of  the recommended civil penalty assessed
 in the initial decision, the  Presiding Officer must consider, in addition
 to the criteria listed  in  Section 14(a)(3)  of FIFSA, the following:

      •  Respondent's history  of compliance  with the Act or its predecessor
         statute; and

      •  Any evidence of good  faith or  lack  thereof.

 The Presiding Officer must  also consider the  guidelines for the assessment
 of civil penalties under FIFRA [39 Fed.  Reg.  27711 (1974)].
 22.35(c)

 Specific reasons must be set  forth in  the initial decision if the Presiding
 Officer increases or decreases the amount of  penalty from that originally
 assessed In the complaint.  The Presiding Officer, however, cannot increase
 the amount of penalty from  that which  was recommended in the complaint if
 the respondent has defaulted.


       age to Initial Decision
 The initial decision becomes a final  order  within 45 days after it is
 served unless:

      •  A party files a motion to reopen  the  hearing, which stops the
         45-day period until the motion  is denied or the reopened hearing is
         concluded; or
         22.28

      •  A party makes an appeal to the  Administrator, or the Administrator
         determines sua sponte that .a  rev-iew ,of the initial .decision is
        ~. ajipropriat e•
         22.27
 Motion To Reopen a Hearing _


 ,If • .a , jaaxty :belleves .that -.f*i*'**'-i'M*f * evidence ^should • ifee ^iBtxp>rt7j jwy>-vake>a raotlon to reopen o£be bearing.   Such a notion
 must be made no later than 20 days after service of  the  initial decision on
 the parties.  The motion to reopen the hearing oust  state  the specific
 grounds upon which relief is sought, state the nature and  purpose of the
 evidence to be adduced, and show that the evidence Is not  merely
 cumulative.  The party must also demonstrate why the evidence was not
 Introduced at the hearing.  The motion must be written and must comply with
                                             >sad ^£he  filing* •service, and
 22.28(a)
                  n'tB •for '' 8 uluittlng documents
       Compliance/Enforcement             7-89          ani^^n^a ttann»t  1983

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Chapter Seven	Hffar*"g Stagy
Replies from other parties must  be  made  within 10 days after the motion is
served.  The Presiding Officer must render  a decision on the motion as soon
as is practicable after  the filing  of  replies.
22.28(b)

Filing a motion to reopen a hearing shall automatically stay the running of
all time periods (e.g.,  appeals) until such time as  the motion is denied or
the reopened hearing is  concluded.
22.28(b)
Appeals of Interlocutory Orders or Rulings
Immediately Appealable Orders

The only orders or rulings  that may be  appealed to the Administrator as a
matter of right are:

     •  Accelerated decisions  that  decide  the entire case;
        22.20, 22.29

     •  Dismissal Orders;
        22.20, 22.29

     •  Default orders; and
        22.17, 22.29

     •  Initial decisions rendered  after an  evidentiary hearing.
        22.27, 22.29

All other orders or rulings issued  by an Agency official during the
prehearlng and hearing proceedings  are  considered  Interlocutory.  As such,
they must await the issuance of an  initial decision before they can be
appealed, unless the Agency official issuing such  orders or rulings
certifies them to the Administrator on  appeal.
22.29
Procedures and Standards for Interlocutory Orders

A motion for Interlocutory appeal of an order  or ruling mast be filed In
writing within six days of notice of such ruling or  order.
22.29

Besides stating the grounds for appeal, the moving party must demonstrate,
to the appropriate Agency official, that:

     •  The order or ruling involves Important legal or policy issues
        concerning which there is substantial  grounds for difference of
        opinion; and
      aompit ance/ Barorceaent              7-90           Qnidgn^ fttnnai  1983

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 Chapter Seven	__	Hearing Stage
      •  Immediate appeal will materially advance  the  proceeding  or  that
         waiting for normal review will be ineffective or  inadequate.
         22.29(b)

 The motion must also comply with requirements for filing, service,  and
 content requirements specified in the CROP.

 If the Presiding Officer does not certify the interlocutory appeal, a party
 may make a motion to the Administrator within six days of service to
 reverse that decision on the grounds that It is contrary  to the  public
 interest..  Ibis motion must also, comply with the  requirements of Section
 22.16 and 22.05 of the CROP, except that the appropriate Agency  officials
 receiving the motion are the Regional Hearing Clerk and the Administrator.
 22.29(c)


 Actions by the
 If the Presiding Officer certifies the Interlocutory appeal, the
: Administrator may?
22.29lte '«tay.  TS. the "Presiding Officer
grants  a request for stay of over 30 days, it must be separately approved
by the  Administrator.
22.29(d)
       fYiapllimrr/Fnfnrrrmrnt             7-91

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Chapter Seven
                 Exhibit 7-4
                            Sample Default Order
                UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                 REGION III
                           6TH AND WALNUT STREETS
                      PHILADELPHIA, PENNSYLVANIA   19106
  In re:

  W.G. Neudecker and Sons
  1215 Madison Avenue, N.E.
  Washington, D.C.  20019
        Respondent
                            Preliminary Statement
I.F.&R. Docket No. III-54C
   DEFAULT ORDER
  This civil proceeding for the assessment of a penalty was  Initiated
  pursuant to Section 14(a) of the Federal Insecticide, Fungicide,  and
  Rodentlclde Act, as amended, 7 U.S.C. 5136 et seq., (hereinafter  referred
  to as FIFRA) charging that the unregistered pesticide, "Adclde for
  Algae Control," was shipped from Washington, D.C., to Rockvllle,
  Maryland,  on September 11, 1982, In violation of  Section 12(a)(l)(A)  of
  FIFRA [7 U.S.C. Sl36j(a)(l)(A)].  It Is hereby determined  that an appro-
  priate default order shall be Issued based on the findings of fact and
  conclusions of law as set forth below.
                               Findings of Fact

  1.   Two cases, each bearing four one-gallon bottles of the product,
  "Adclde for Algae Control," were shipped by W.G. Neudecker and  Sons
  (respondent) from 1215 Madison Avenue, N.E., Washington, D.C.,  to Water
  Way In., 5544 Sycamore Lane, Rockvllle, Maryland, on or about September
  11, 1982 (Shipping Order No. 45643).  A sample from said shipment was
  obtained subsequently by representatives of the Environmental
  Protection Agency (EPA), Region III.

  2.   At the time of said shipment, the product sample bore a label
  that It was Intended for the prevention of algae and slime.

  3.   At the time of the said shipment, said product was not registered as
  a pesticide with EPA.

  4.   On July 16, 1983, the Enforcement Division, EPA, Region III (the
  complainant), issued a complaint and notice of opportunity for  hearing to
  respondent, pursuant to Section 14(a) of FIFRA [7 U.S.C. i!361(a)],
  alleging that respondent had violated Section 12(a)(l)(A) of FIFRA by
  shipping an unregistered pesticide in Interstate commerce [7 U.S.C.
  f136j(a)(l)(A)J.  (A copy of the complaint is annexed hereto as
  Attachment A.)
                                         7-92
        Guidance Manual 1983

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 Chapter Seven         	            	Exhibit  7-4
.'\
   5.   In the complaint, a civil penalty of $2,300 was  proposed  against
   respondent.  Said penalty was proposed on the basis  of  its  appropriate-
   ness to the size of respondent's business, the effect on  respondent's
   ability to stay In business, and the gravity of the  violation as calcu-
   lated by reference to the EPA "Guidelines for the Assessment  Section
   14(a); Citation Charges for Violations" [39 Fed. Beg. 27711 (1974)].   For
   purposes of assessing said penalty, respondent's gross  annual  sales were
   determined to be between $200,000 and $1 million during the previous
   year.  Based on prior information communicated to complainant by the
   president of .respondent, respondent was considered to have  had knowledge
   t>f  the registration requirement.  Accordingly, the proposed penalty was
   assessed at $2,300.  Furthermore, based on a comparison of  respondent's
   gross annual sales with the amount of the proposed penalty, it was
   determined that said penalty would have no substantial  effect on
   respondent's ability to continue in business.

   6.   The complaint in the Instant case set forth respondent's  right to
   request a hearing within twenty (20) days of receipt of the complaint,
   the retpjlrcaent of a written answer to the complaint, and .the conse-
   quences of failure to answer the complaint.  Furthermore, a copy of the
   Consolidated Rules of Practice (CROP), 40 C.F.R. §22.01 et  seq., was
   enclosed with the complaint.

   7.   Said complaint was mailed to respondent on July  16, 1983,  via
   certified mall.  Receipt No. 202684 was returned to  complainant, stamped
   July 17, 1983,  and bearing the signature "Betty Wilson" as  signer for
   the addressee.   (Copy enclosed as Attachment B.)

   8.   As of this  date, respondent has failed either to respond  to the
   complaint, request a formal hearing, or file an answer  to the  complaint
  naranant to .the CROP.
                               Conclusions of Law

  1.  At  the  time  of above shipment, said product was a pesticide within
  the meaning of  Section 2(u) of FIFRA by virtue of its label claim of use
            ijT*^ *m fmm+ »<>Wn Thr •••n1nu. of "St Llluu 'J(lJ :of TZERA*  [7
        i -fS 13*(n),
  2*  By reason of the facts as set out In the findings of fact, respondent
  violated  Section 12(a)(l)(A) of FIFRA by shipping an unregistered pesti-
  cide In interstate  commerce.  [7 U.S.C. f 136j(a)(l)(A)]

  3.  By falling to ,file ,a. tiaeljr •-, an ever -to ,<£he, ccauvlaint and to request a
  -<*••••** :frn«Ti-ng,  TMpoadant 3a« '•«%«**••* the £aets alleged In the com-
  plaint and  has waived its right to a hearing.  Accordingly, respondent
  is In default and the proposed civil penalty is therefore due and pay-
  able.  [CROP, 40 C.F.R.  S22.17J
FIFRA Oaapliance/Bnforcement             7-93          Guidance Manual 1983

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Chapter Seven	    »»*»•*hit 7-4
  4.  It is further concluded that by  reason of  the facts as set out In
  paragraph five (5) of the findings of  fact,  the amount of the proposed
  penalty is appropriate pursuant to Section 14(a)(4)  of FIFRA [7 U.S.C.
  Sl361(a)(4)] for the following reasons:

       a.  The penalty is appropriate  to the size of the business;

       b.  The size of the penalty would have no significant effect on
           respondent's ability to continue  in business; and

       c.  The violation involves the  extremely  grave charge of Interstate
           shipment of an unregistered pesticide.
                                Order

  Respondent shall within sixty (60) days  of  receipt of this default order
  pay by cashier's or certified check  a  civil penalty in the amount of two
  thousand three hundred dollars  ($2,300)  to  the Treasurer, United States
  of America.  Such remittance may be  sent by messenger or certified mail
  to the Pesticides Hearing Clerk, U.S.  Environmental Protection Agency,
  Region III, Curtis Building, 6th & Walnut Streets, Philadelphia,
  Pa. 19106.  In the event of failure  of respondent to make said payment
  within sixty (60) days of receipt of this default order, the matter
  shall be referred to the United States Attorney for the District of
  Columbia pursuant to Section lA(a)(5)  of FIFRA [7 U.S.C. Sl361(a)(5)] for
  recovery by appropriate action  in United States District Court.

  AND NOW, THIS DAT OF October 4, 1983 the foregoing order is hereby issued
  under the authority of the Federal Insecticide, Fungicide, and Bodenti-
  cide Act, as amended, and the Consolidated  Rules of Practice adopted
  pursuant thereto.  [7 U.S.C. Sl361(a)(l)-(4);  40 C.F.R. J22.01 et seq.]
                                                   Regional Administrator
FIFRA Coaplisnce/Baforceseat             7-94           Qn±4fn*** gasaal 1933

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Chapter Seven
                                                                 Exhibit 7-5
                  Model Consent Agreement  and Final Order
  Environmental Protection Agency

  In re:

  W.6. Neudecker and Sons
  1215 Madison Avenue, N.E.,
  Washington, D.C.  20019
        Respondent
                                                I.F.&R. Docket No. III-54C
                                                CONSENT AGREEMENT AND
                                                     FINAL ORDER
                            Preliminary Statement

  1.  This civil proceeding for the assessment of a penalty was  initiated
  pursuant to Section 14(a) of the Federal Insecticide, Fungicide, and
  Rodffnficide Act,, as artPTidfrU  [7 P.S-C. J136 et seq. (hereinafter
  FIFRA). ]  The action was Instituted by a complaint and notice  of
  opportunity for hearing, filed upon respondent pursuant  to FIFRA,
  charging violations of (cite specific sections of the Act)	
  2.  Respondent filed an answer admitting the Jurlsdictional allegations
  of the complaint, admits       (facts admitted)	,
  and explains (neither admits nor denies)   (facts explained)	.
  3.  Respondent  hereby explicitly waives the right to request a hearing on
  any issue  consented to herein.

  4,  leapo
                 consents to the Issuance of the order hereinafter recited,
  with the stipulations and admission of facts and conclusions of law for
  the purposes of this proceeding only.  Respondent consents to the payment
  of a civil penalty of the amount set out in the order.

                              Findings of Fact

  [The "Findings of Fact" section shall state with particularity
                        -respect t"<
                             Conclusions of Law

  By reason of the facts set forth in the "Findings of Fact," it is
  concluded that respondent Jus «l
-------
Chapter Seven
                       Exhibit 7-5
                                  Order
  Respondent shall within sixty (60) days  of  receipt  of this consent
  agreement and final order, pay by cashier's or certified check a civil
  penalty In the amount of  ($	)_  dollars,  payable to the Treasurer
  United States of America.  Such payment  shall  be  remitted to the Hearing
  Clerk, EPA Region	,  (address)   .   Failure  to remit such payment
  will result In the referral of this matter  to  the United States Attorney
  General for collection pursuant to Section  14(a)(5) of FIFRA, as amended.

                             [Alternative  Order]

  Based on a finding that the payment of any  or  all of the penalty herein-
  before addressed would materially affect respondent's ability to continue
  In business, respondent, having duly stipulated to  the violations as
  charged, is excused from payment in accordance with the terms of Section
  14(a)(4) of FIFRA, as amended.

                                    (Signature of respondent)	
                                     (Signature  of  complainant)
                                  Date:
             At:
  It is so ordered.  This order shall  become  effective Immediately.
                                    (Signature  of Regional Administrator)
                                    Regional Administrator, EPA Region
                                     (Title)
                                    EPA Region
                                    Date:
               At:
FIFRA CoHpliance/Enfott
7-96
f+ Itmimal 1983

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 Chapter Seven
 6     Post-Hearing  Stage
 Appeal of Initial  Decision
Jurisdiction of
 The Administrator assumes  full jurisdiction of the case immediately after
 the Presiding Officer  issues an initial decision.  The Administrator
 assumes jurisdiction regardless of whether or not a party appeals  the
 Initial decision.   If, however, a party files a motion to reopen a hearing,
 the Presiding Officer  may  rule on that motion.
 22.27(c)

 Once the initial  decision  is issued, the Regional Hearing Clerk's  File,
 which now Includes the original initial decision, is forwarded  to  the
 Hearing Clerk.  Consequently, the appellant must send any notice of appeal
 and accompanying  appellate brief to the, Bearing Clerk.  A .motion to reopen
        ag* however,  is to
 22.27(a),  22.30(a)


 Notice of  Appeal  and Appellate Brief

 The notice of  appeal and appellate brief must comply with the  general
 filing, service,  and form requirements of the CROP where  appropriate.  The
. fM*fr-f•£* ,cQ£  ^pp»-f1 .anA tit* -.appellate -ttTtff ^****" •-**»' -f41»ti:*ri1'*t -yh» goa-iHttg

 22.30(a)(D

 The notice of  appeal must address the disputed findings of fact and
 conclusions of law contained in the Initial decision. Specifically, it
 •ust contain:

                             Jf fact;
      •   Alternative conclusions regarding issues of law or discretion;

      •   A proposed order that reflects the conclusions  and findings desired
         by the  appellant; and
 FOKA. GMpllance/&iforceme&t             7-97          ftHd^t*^ Manual 1983

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Chapter  Seven	Poat-H«»«"-1pg Stage
     •  Relevant  references  to the record and the Initial decision.
        22.30(a)(l)

The appellate brief is  intended to present the appellant's arguments as to
why the appeal should be granted.   AB  such, it must include:

     •  A  statement of  issues  presented for review;

     •  A  statement of  the nature  of the case;

     •  Identification  of the  facts that are relevant to the issues
        presented for review;

     •  Specific  arguments on  the  issues presented;

     •  A  short conclusion that includes the precise relief being sought;
        and

     •  Appropriate references to  the  record and the initial decision.


Party's Reply

Any other  party or amicus curiae may file a reply brief with the Hearing
Clerk within 15 days of service of a notice of appeal and appellate brief.
The reply  brief is specifically intended to address only the appellate
brief and  should  be so  limited. Therefore* it should respond to the
argument raised by the  appellant,  together with references to the relevant
portions of the record, initial decision, or appellate brief.  The reply
brief must also comply  with  service, filing, and content requirements
specified  by the  CROP.
22.30(a)(2)


AdnyftHstrator *s Actions

Even if the initial decision is not formally appealed, the Administrator
may determine sua sponte that  a review of the initial decision is
necessary.  The Administrator, however, has only 45 days after service of
the Initial decision to review the initial decision sua sponte.  Otherwise,
the initial decision of the  Presiding  Officer becomes the final order of
the Administrator.  22.27(c),  22.30(b)  If the Administrator determines to
review the initial decision  sua sponte, the Hearing Clerk shall serve
notice of such Intention upon  the  parties.  The notice will include a
statement of issues to  be briefed  by the parties and a time schedule for
the service and filing  of briefs.
22.30(b)
      uompJJLance/Enzorcement              7-70          Guidance fiaimai 1983

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 Chapter Seven	              Post-Bearing Stage
 Scope  of  Review

 The  appeal of the Initial decision must concern only those issues raised by
 the  parties in the previous proceeding.
 22.30(c)


 Oral Argument on Appeal

 Oral argument on appeal is not automatic and may be granted only if a party
 makes a request to the Administrator or the Administrator orders it sua
 sponte.   In assigning a time and place for oral argument, the Administrator
 must consider, the convenience of the parties.  There are no standards
 specified in the CROP for deciding whether oral argument should be heard.
 22.30(4)
.Final Order
Timing and  Content

The Administrator  is required to issue a final order as soon as is
practicable after  the final action of the appeal process—either after
filing of appellate briefs, filing of subsequent briefs if ordered by the
Administrator,  or  oral argument, whichever occurs last.
22.31

The Administrator may, in the final order:

     •  Adopt, modify, or .-*et aside all or maae of the .findings mad
        conclusions contained in the initial decision or order; and

     •  Increase or decrease the recommended penalty unless the initial
        decision is a default order (in which case the Administrator may
        not Increase the recommended penalty).

The CROP requires  the final order to contain the reasons for any decision
Motion To Reconsider  and Stay Request

A party may  file  a motion to reconsider a final order within 10 days after
service of the final  order.   A motion  to reconsider must set forth the
matters claimed to have  been erroneously decided and the nature of the
                  Ihe mot Ian may Jilso 1-nclndr.«  raqiaiT £hat the final order
          Tending a resolution of the  motion  to reconsider,  unless such a
request for  stay  is granted,  however,  the effective date of the final order
is the date  on which  it  was  issued, unless otherwise ordered by the
Administrator.
22.32
      rnmpiinnrr/rrnrnrrrmcnt              7-9y           fSn4Am^t*f Msmrii  1983

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Chapter Seven          	Post-Bearing Stage
Appeal From Final Order

A party may appeal the findings of  the  final  order to a United States court
of appeals pursuant to the provisions of  Section 16(b) of FIFRA.  The
obligation to pay the civil penalty does  not  become due until the party has
exhausted all appeals*
Notice of Judgment


Upon signature of the final order by  the  Regional Administrator, the case
will be closed and a notice of judgment prepared and sent to Headquarters
for publication in accordance with  the requirements under Section 16(d) of
the Act.  (See Appendix 2, Notices  of Judgment.)
Payment of Penalty
The payment of the civil penalty specified  in a final order of the
Administrator is due and payable in full within 60 days after the
respondent receives the final order, unless otherwise agreed by the
parties.
22.31(b)
FXFK& coap n mice/ anxorceaeat              7-iOO         Goloamce Banna 8 1983

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Chapter Eight
Judicial  Enforcement:   Civil  Actions
Chapter Contents                                           Page

1  Introduction                                            8-1


2  Elements of a Violation;  Civil                           8-3

   Evidence in Support of Civil Actions                       8-3
   Use of Expert Witnesses                                  8-4


3  Procedures for Filing Actions                             8-5

   JErhibit 8-T:  Itodel Civil Litigatitm leport
                Outline and Guide                           8-8


4  Injunctive Actions                                       8-17

   Statutory Authority                                      8-17
   Justification for Seeking Injunctive Belief                 8-17
   Procedures for .Seeking .Injunctive ..Belief                   8-18
   Exhibit 8-2:  Model Motion for Temporary
                Restraining Order                           8-22
   Exhibit 8-3:  Model Motion for Preliminary
                Injunction                                  8-23
   Exhibit 8-4:  Model Affidavit in Support of
                Motion for Preliminary Injunction             8-24
               "Mnrif 1 -itotion jfor • *£t£Btucstt
                Injunction                                  8-25
      inmp11 •nrr/rnrnrrrm or            o—i         "«'<'ir^ir* namiii  1983

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Chapter Eight	      Contents


5  In Rem (Seizure) Actions                                       8-27

   Statutory Authority                                            8-27
   Enforcement Criteria                                           8-27
   JLn Rem Procedures                                              8-28
   Compliance With a Seizure                                      8-29
   Disposition of a Seizure                                       8-29
   Exhibit 8-6:  Model Complaint In Rem                          8-31
   Exhibit 8-7:  Model Report of Supervision
                 of Disposition                                   8-34
   Exhibit 8-8:  Model Expenditure Report  Form                   8-35


6  Settlement Agreements                                          8-37
      Goflpliance/Enforceaent8-iiGuidance Manual 1983

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Chapter Eight
1     Introduction
Under FIFRA, regulatory remedies are Initially and  primarily handled  .
through the .use of administrative actions.  However, in tho«e Instances
vbere EPA ,±« unable to obtain compliance with administrative actions, the
Act authorizes EPA to seek relief through civil court injunctive and in rem
(seizure) proceedings.

An injunction is a writ Issued by a court forbidding or commanding a person
to perform a particular act.  Injunctions Involve the equity powers of
Federal courts and are generally viewed as  an extraordinary form of
relief.  Consequently, they are not readily granted and a party seeking
injunctive relief has a heavy burden in demonstrating the need for such
action.

In rem (seizure) proceedings signify «"•«•* gffa*""* *"hingj xather than
Iniilyldiails*.  Therefore, a proceeding "in rcn" Is one taken against
property and has for its object the disposition of  the property.
      mapninrrjimrnrrraf nr            o-i           Guidance Iff1"**'  1983

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Chapter Eight  	Introduction
FIFSA Gcmpliance/Eaforce*ent             8-2           g^fd*"*^ Manual 1983

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Chapter Eight
2     Elements  of  a  Violation:   Civil
Evidence In Support of Civil Actions
Civil actions require supportive evidence that goes  beyond the prima facie
evidence necessary to establish administrative violations of FIFRA.  In
some Instances,  this  may require the use of expert witnesses to establish
certain elements of proof (e.g., immediate and irreparable injury).  Below
follows a list of additional evidentiary showings that  should be met before
undertaking an injunctive or in rem action.


Injunctive Actions*
                      h»»» *»qn*-r»d *K» -p^-n-in.™^ w plaintiff to make -the
following showings before a permanent injunction would be issued:

     •  There is an inadequate remedy at law;

     •  The applicable  administrative remedies  have been exhausted; and

     •  Irreparable injury, loss, or damage will result if the relief is
Issuance of a preliminary Injunction or temporary restraining order would
require the following additional showings:

     •  Immediate and Irreparable Injury, loss, or damage will result if
        the relief is not granted; and
* These actions may consist of permanent injunctions, preliminary
  injunctions,  or temporary restraining orders.  These types of injunctions
  are discussed in more detail in Section 4 of this chapter.
                                        8-3

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Chapter Eight	Elements of a Violation;   Civil
     •  There is a likelihood of success at trial, based  on facts  before
        the court.

The above criteria are not, however, uniformly applied  by the  various
judicial districts.  While some jurisdictions emphasize different  aspects
of the criteria, other courts have developed alternative  tests that  use
some, but not all, of the elements listed above.  For this reason, an
attorney considering this type of civil action should research recent
trends in the jurisdiction in which the Injunction is being sought.


In Rem (Seizure) Actions

For a pesticide or pestlcidal device, the Act specifies that the following
jurlsdictional conditions be met before initiating an In  rem (seizure)
proceeding:

     •  The pesticide or device is found and seized within the jurisdiction
        of the district court that will hear the  action;  and

     •  The pesticide or device is being transported or,  having been
        transported, remains unsold or in original unbroken packages; or

     •  The pesticide or device is sold or offered for  sale in any State;
        or

     •  The pesticide or device is imported from  a foreign country.
Use of Expert Witnesses    	


As in the case of administrative actions, civil judicial  enforcement
proceedings generally require the presentation of expert  testimony  by  EPA
personnel appearing as witnesses.  Such testimony is used to  establish
certain elements of proof that justify the relief sought  (e.g.,  the showing
of inmediate and irreparable Injury for obtaining an injunction).
Witnesses should be selected for their direct knowledge of the
circumstances surrounding the suspected violation, because the witnesses
will be required to relate any such knowledge to the court.   (See Appendix .
5, "Expert Witnesses.")
FIFRA Compliance/Enxor

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Chapter Eight
3     Procedures for  Filing  Actions
Bequests for FIFBA civil court  actions are referred to the Department of
Justice or *he appropriate Bolted States (Attorneys Off ice  by .the Associate
Administrator f or OtEC (or the  Associate Administrator's designee) .*  In
oos t instances, the Regional Office will initiate the request  for an
Injunction or an In rem action  and will designate the lead Agency
attorney.**  The lead attorney  is responsible for preparing the "referral
package," which, upon completion, is sent from the Regional Office to
OLEC.  A copy of the package should also be forwarded to PTSCMS.

A referral package contains :

     •  Referral Memorandum* A referral memorandum identifies the primary
        elements of the proposed litigation.  Specifically, the memorandum,
        ft A- Jt
        -  Identification of  the potential defendants;

        -  Brief factual summary of the case;

        -  Identification of  the major issues (including  potential problems
           that may exist with the case);
   The Regional Office has  Independent authority to refer requests for
   emergency temporary restraining orders under FIFRA to the Department of
   Justice and the appropriate United States Attorneys Office.  Vhen
   exercising this authority, however, the Regional Administrator wist
   notify the Associate Administrator for OLEC and  the Assistant
   Administrator for Pesticides and Toxic Substances (or their designees.).

   Headquarters -program and "Enforcement Counsel staff may participate more
   actively in the case development process if precedential or nationally
   significant Issues are involved.
                                        8-5

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Chapter Eight     	Procedures  for Filing Actions
        -  Status of past Agency enforcement efforts; and

        -  Names of Agency and Department of Justice attorneys who are
           involved in the case, including the  lead attorney.

     •  Civil Litigation Report.  In addition to  the referral  memorandum,
        the referral package must contain a litigation  report, prepared by
        the designated lead EPA attorney.  (For a complete outline and
        guide to preparing the report, see Exhibit 8-1•)   The  report must
        Include a synopsis of the facts and history of  the violation,
        including past violations by the potential defendant.   The report
        must cite the specific sections of FIFRA  and its regulations that
        have been violated.

        The report must show that all elements  of the violation have been
        satisfied.  For each element, the report  should indicate the
        available supporting evidence.  A copy  of the necessary documentary
        evidence and summary of the expected expert testimony  should be
        attached to the litigation report.

        The lead attorney should include a statement regarding the specific
        relief to be sought (e.g., injunctive or  in rent action).  The
        report should also include a list of any  equities  that may weigh
        against granting the relief sought by EPA; any  expected defenses by
        the violator (and how they will be countered);  and any past,
        anticipated, or pending State or Federal  actions (administrative or
        judicial) against the violator.  Where  an injunction is requested,
        the report should discuss the likelihood  that the  violator would
        comply without the Imposition of an injunction.

Once the referral package is received by Headquarters,  Enforcement Counsel
attorneys will conduct a limited final legal review to  ensure  completeness
and consistency in application of enforcement policy.   The ease will then
be transmitted to the Department of Justice or  the appropriate United
States Attorneys Office.  OLEC will notify the  Regional Administrator and
the Assistant Administrator for Pesticides and  Toxic Substances (or their
deslgnees) upon the transmittal of the civil referral.

Following the referral of a case, the lead EPA  attorney will be responsible
for coordinating responses to all requests for  supplemental information by
the Department of Justice or the United States  Attorneys Office.  The lead
Agency attorney also will be responsible for keeping program officials  and
other previously Involved Agency attorneys apprised of  case developments
after referral.

Agency employees who are Involved in the Investigation  and referral to  the
Department of Justice of civil FIFRA actions should familiarize themselves
with the Agency documents listed below.  These  documents are contained  In
EPA's General Enforcement Policy Compendium.

     •  Memorandum of Understanding Between the Department of  Justice and
        the Environmental Protection Agency (6/15/77);
PUKKA Uottpliance/Enforceaent             8-6          Onldmc* MMMMLL

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 Chapter Eight	  Procedures for Filing Actions
      •  Quantico Guidelines for Enforcement Litigation (4/8/82);

      •  General Operating Procedures for EPA's Civil Enforcement Program
         (7/6/82); and

      •  Case Referrals for Civil Litigation (9/7/82).
FIFEA GMpllance/Bnforceaent             8-7          Guidance Manual  1983

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Chapter Eight	Exhibit  8-1


              Model  Civil Litigation Report Outline and Guide*
  Title Page

  A.  Identify  the facility by name and location and indicate the parent
      company if different  from the facility name.

  B.  Identify  who prepared the report (both legal and technical
      personnel) indicating addresses and telephone numbers.

  C.  Show the  date of  completion/submission of the report.


  Table of Contents (Standardized Example)

  I.    Information Identifying the Defendant(s)               Page 	

  II.   Synopsis of the Case                                   Page	

  III.  Statutory Authority                                    Page 	

  IV.   Description of  Defendant's  Business and
        Technical Description  of the Pollution Source          Page 	

        A.  Facility  Description                               Page 	

        B.  Source of Pollution                                Page 	

        C.  Pollutants  Involved; Environmental Harm
            (Where Appropriate)                                Page 	

        D.  Available Control  Technology and/or
            Bemedial Action                                    Page 	
     The Model Civil Litigation  Report Outline and Guide Is to be used
     for all Agency civil  referrals  to the Department of Justice*  Civil
     litigation reports, however,  are most frequently used In referring
     civil court actions under statutes other than FIFBA.  Therefore,
     certain sections of the  report  would not need to be as detailed as
     those prepared for referrals  involving non-FIFRA violations.  For
     example, since FIFRA  referrals  Involve only requests for injunctive
     or in rem relief, civil  penalties would not need to be discussed In
     Section VII of the report (Relief Requested).
FIFBA O>*»|t1 •! tmfp/'Btnftprfaffxftf              &~S         &** tfms^ff* ftetMial 1983

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 Chapter Eight	                   Exhibit 8-1
   V.     Administrative and Enforcement  History                 Page

   VI.    Required Elements of Proof and  Evidence                Page

         A.  Elements of Proof                                   Page

         B.  Evidence of Violation                               Page

         C.  Evidence of Environmental Barm
             (Where : Appropriate )                                 Page

         D.  Discovery                                           Page

         E.  Evidence Favorable to Violator                      Page

         F.  Government Witnesses                                Page

         6.  Defense Witnesses                                   Page

         H.  Resource Needs                                      Page

   VII.   Relief Requested                                        Page

         A.  Preliminary Injunction                              Page

         B.  Standards To Be Met                                 Page

         C.  Compliance Schedule                                 Page

         D.  Stipulated Contempt Fines                           Page

        ^E. -"'""Civil Penalties                                     Page

         F.  Necessary Bonds                                     Page

   VIII.  Anticipated Issues                                      Page

         A.  Possible Defenses                                   Page
         C.   Pending Related Administrative or Court Action      Page

         D*   Other Issues                                        Page

         E.   Discussion of Any Potential Practical
           ... Problem With Che. Case                            ..--•. ;fbge

  IX.    Litigation Strategy                                     Page

         A.   Need  for Preliminary Injunction                     Page
FIFBA 1\mp1 1 imrr/TTnf orccacnt             8-9          ort«i^m»g MM^I  1983

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Chapter Eight	  Exhibit 8-1
        B.  Potential for Summary Judgment                      Page 	

        C.  Settlement Potential                                Page 	

        D.  Other Potential Defendants                          Page 	


  X.    Index of Attachments                                    Page	


  XI.   Attachments                                             Page	

        •  Copies of correspondence
        •  Copies of relevant regulated  submissions
        •  Copies of relevant policy memo8,  regulations, interpretations


  Body of the Report

  I.    Information Identifying the Defendant(s)

        A.  Legal name of company

        B.  Address:  Corporate headquarters

        C.  Name of facility (if different from "A")

        D.  Address of facility (if different  from "B")

        E.  SIC code

        F.  State of incorporation

        6.  Registered agent for service

        H.  Legal counsel (name, address,  telephone number)

        I.  Judicial district in which violator is located


  II.   Synopsis of the Case

        This section should be a one-or  two-page  articulation of the heart
        of the case.  It should describe both  the violation and the
        proposed relief.  It should not  describe  statutory authority or
        intricate legal issues in detail.

        This succinct statement of the case  will  provide the reader a
        framework In which to fit the details  developed and presented in
        the body of the litigation report.
FIFRA GMTO!lance/Hnf/vivomoT^              a_in

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Chapter  Eight            	  	 Exhibit 8-1
         The factual basis of the case should be touched upon.  Purely
         conclusory characterization of the case is not as useful as
         showing the facts of a violation and requested relief.  For
         example,  it Is better to say a violator discharged or emitted X
         quantity  of T pollutant for Z days, than to simply say that the
         violator  did not comply with the terms of a permit, State Imple-
         mentation Plan (SIP), or statute.

         The environmental seriousness of the violation, its ongoing
         nature, and a viola tor'a -recalcitrance may be touched upon in
         this section (but -sill also be developed later in paragraph
  III.   Statutory Authority

         A.   Present the substantive requirements of the lav and
             applicable regulations.  Beference all federal statutes by
             U.S.C*  citation as veil ^ as by the section of the pertinent
             Act.   Summarize the  enforcement authority, jurisdiction, and
             venue.   Specific elements of proof are to be addressed in
             paragraph VI.

         B.   Lengthy dissertation on the law is unnecessary.  However, in
             the instance of State Implementation Plans under the Clean
             Air Act,  or Water Quality Standards under the Clean Water Act,
             or Involvement of any other state law or regulation, a more
             extensive explanation of the law or regulation may be
             necessary.  Pertinent excerpts from any applicable state
             laws  or regulations  should be identified and attached to the
             litigation report.

         C.   Any prior Interpretation of pertinent state laws or
             regulations which are germane to the case should be
             referenced when identifying the law violated.  If a state's
             interpretation of the law has been different from ours, the
             Issue should be discussed with the state and fully explained
             In this section of the litigation report.  (This section may
             then  be referenced when discussing potential defenses, etc.,
         • • -  111 m m m I I • I Mil ' TH 11 ' -\
          - ..-331 .jySil •|ftl ffa. WAt tm)

         D.   List  any other possible theories of violation under federal,
             state,  or common law.
  IV.   Description of  the Defendant's  Business and Technical Description
        of the Pollution
        A.  Describe  the  violating  corporation and the particular
            division  or facility  in question.   Any interesting corporate
            Interrelationships or subsidiaries should be noted.
FIF1A GbHpUance/Bfeforeemeat             8-11         ^•'IJOTCP Manual 1983

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Chapter Eight	Exhibit 8-1
        B.  Discuss the business of the corporation  and/or division,
            providing details about the facility in  question,  what is
            produced, and what causes the pollution.  Emphasis should be
            on the particular process that is causing  the problem.  Plant
            and process should be thoroughly explained,  including those
            outfalls or emission points not subject  to this enforcement
            action.  Diagrams should be referenced and attached to, or
            included in, the litigation report.  Photographs of the
            source may be helpful.

        C.  Discuss the types of pollutants being discharged,  and
            potential health and environmental effects.   Although the
            seriousness of the violation is not technically a  requirement
            of proof in enforcement of certain statutes, it is sometimes
            relevant to the assessment of penalties  and  equitable
            relief.  For this reason, it should be discussed in the report
            although it will not be the sole determinant of whether a
            case has prosecutorial merit.  The Department of Justice has
            suggested the following considerations in  assessing the
            seriousness of the violation:

            •  The discharge of toxics or mutagens or  carcinogens is  more
               serious than the discharge of conventional pollutants;

            •  The discharge of large quantities of  pollutants
               is more important than the discharge  of small quantities;

            •  Bioaccumulative wastes posing long-term threats are more
               serious than biodegradable wastes;

            •  The discharge of pollutants in an area  not attaining
               primary ambient air quality standards is  more important
               than discharges in an area not meeting  secondary
               standards;

            •  The discharge of pollutants that directly and demonstrably
               affect health or the environment is more  than those that
               have no direct or obvious effect;

            •  Ongoing present violations that the Government  seeks to
               stop are more important than episodic violations which
               have ceased; and

            •  A defendant with a history of violations  Is more worthy
               of attention than a first offender.

            If a case does not present obvious "serious" health effects
            or environmental harm, but is compelling for some  other
            reason (e.g., deterrence of continued, blatant violations of
            the law), this should be Indicated.
TTFRA ffrmnl < anr* /ttnfn-ri-^mfi nf             Q-T7         _on* «l
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 Chapter  Eight	Exhibit 8-1
         D.   Discuss available methods of controlling the problem.
             Specify technology(s) that will achieve the imposed limits,
             and indicate the time requirements for a schedule of
             compliance which considers time necessary for design,
             contracting, construction, and startup.  (This is not
             inconsistent with EPA policy of not prescribing specific
             compliance technologies.  This information may be necessary
             in court to illustrate technical feasibility if requested by
             the judge.)

             Cost estimates should be included, to the extent known.
             Indicate the reliability of the estimates.  (Reference
             paragraph VII(E) as appropriate.)
  V.     Chronological Administrative History and/or Earlier Enforcement
         Actions  (State and Federal)
        A-  Show all attempts - to exact compliance or . iapose sanctions
            administratively or judicially that have been considered or
            taken.   A full historical chronology should be presented.

        B.  Indicate whether necessary notice pursuant to the statutory
            requirements has been given to the violator prior to
            initiation of court action.
 VI.   Required Elements of Proof and Evidence

        A.  List  the  necessary elements of proof to establish the
        B.  Present  a detailed,  objective, factual analysis of all real,
            documentary,  and testimonial evidence corresponding to each
            necessary element of proof  in paragraph VI(A) above.

            Indicate the  location of  all real  evidence.

            Reference each item  of documentary evidence as an attachment,
        •- ••. -**GMKp£-.---*l>Bre';Jit Isvt&o >?volnBlaDas  -Clsi which case indicate Its
            present  location) .

            Identify all  witnesses by name (indicating whether lay or
            expert),  when Indicating  the Import and substance of their
            testimony.  Complete addresses and phone numbers of witnesses
            will be  listed in paragraph VII(E) below.
                                                    •vallable fcy
            dis covery,  indicate:

             1.  The  type  of  evidence  anticipated;
FIFRA Cbapllance/Knforceaent              8-13          Guidance Manual 1983

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Chapter Eight
                       Exhibit  8-1
            2.  The person or organization currently having  the
                evidence; and

            3.  The type of discovery to be used.

            Assess the quality of the evidence.  Be objective.   Any facts
            or circumstances that affect the strength of  the Agency's
            proof should be explicitly set forth.  The newness or  oldness
            of evidence is relevant; the dependability of testing
            techniques is Important.  Any assumptions, and the reasons
            for them, should be spelled out.

        D.  If establishing environmental harm is important  to the case,
            set forth the evidence of harm (as done In paragraph VI(B)
            for elements of substantive violation).

        E.  List all evidence favorable to the violator,  Including test
            results that differ from EPA's.  Any relevant fact that may
            bear adversely on the Government's contentions should  be
            highlighted.  Defense witnesses, to the extent they  can be
            anticipated, should be listed in paragraph VI(6).

        F.  List all government witnesses alphabetically  with business
            address, and telephone number and home phone  number.  Quali-
            fications of experts should be given.

            All witnesses listed should have been consulted  and
            thoroughly interviewed.  Paragraph VI(B) should  set  out in
            succinct fashion the actual facts and opinions to be included
            in the testimony.

        G.  List all defense witnesses anticipated, identifying  their
            employment, expertise, etc.  The likely content  of their
            testimony should be set out in paragraph VI(E).

        H.  Indicate projected resource needs (e.g., experts, money,
            etc.).
  VII.  Relief Requested

        This paragraph should Include a comprehensive "bottom-line"
        settlement position on all items of relief necessary, including
        those set forth below.  If there are policy questions or conflicts
        associated with any requested relief, discuss them.  This section
        should be carefully detailed.  It will be relied upon in
        determining the acceptability of any settlement offers/proposed
        consent decrees.

        A.  Preliminary injunction.

        B.  Standards to be met (interim and final).
FIFRA Compliance/Enforcement
8-14
Guidance
1983

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 Chapter Eight            	                Exhibit 8-1
         C.  Compliance schedule for available technology  with phasing,
             duration, etc. (Reference paragraph  IV(D),  as appropriate.)

         D.  Stipulated contempt fines in conjunction with compliance
             schedule .

         E.  Civil Penalties.

             1.  Economic savings realized by the violator should  be
                 analyzed. .The EPA Civil Penalty Evaluation  form  should
                 be completed, discussed, and attached.  Calculations
                 should be included as attachments.  This  section  should
                 Include discussion of all elements developed under EPA's
                 civil penalty policy, Including ability of the  company
                 to pay and recalcitrance.

             2.  Comment on types of credits possible (or  proposed by the
                 violator) , as veil as credits considered  and/or allowed
                'for othrr w*m1 1 *T •-•y* **] ffn-m ^•t-n^ivm^-^ittr -municipal  POTHs).
             3.   If economic savings is not a relevant measure of penalty
                 assessment, explain what basis should be used.

        F.   Necessary bonds.

             Witnesses necessary to establish the relief requested  should
             be  identified by name, address and telephone number, with  a
             brief  summary of the subject of their testimony.
  KX11
        A.   Possible defenses.

             (Analyze only defenses that are likely to be presented;
             fanciful theories can be ignored.)

             1.   Outline legal issues.  Attach legal memoranda on threshold
                 legal Issues (e.g., Chapter 11 Reorganization) or col-

                 ntlgatlon.

             2.   Outline factual Issues.

        B.   Equitable arguments by the violator.
                              -t«
                           >tttd
            facilities;  emission standard to be revised; inability to
            finance;  economic constraints,  etc.)
FIFKA Gnapliance/bforcement:             8-15         &»
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Chapter Eight	Exhibit 8-1
            Any past action, or inaction,  (not  necessarily judicial or
            administrative) by a state or  any EPA office that the
            company may use as an excuse,  or cite for  reliance,   (e.g.,
            promises of less stringent limits;  agreement not to  sue,
            etc.).

        C.  Pendency of any action involving the  violator or EPA on
            related Issues in any court or administrative forum.
            (Reference paragraph V(A), as  necessary.)

        D.  Other possible issues that might arise at  trial.

        E.  Discuss any potential practical problems with the case.


  IX.   Litigation Strategy

        A.  Need for preliminary injunction.

        B.  Potential for summary Judgment.

        C.  Settlement potential.


             1.  Past contacts by EPA, the Department  of Justice or the
                 United States Attorneys Office.

             2.  Present negotiating posture and  assessment of potential
                 for settlement.  Include  comparison of  posture  with
                 "bottom-line" settlement  position from  paragraph VII.

         D.  Other potential defendants.

         E.  Other pending actions against violator.


  X.    Index of Attachments


  XI.   Attachments
FXPSA Gaapllsaee/Eoforeeaent             8-16         Guidance Manual  1983

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Chapter  Eight
4     Injunctive  Actions
Statutory Authority
EPA has the authority to initiate injunctive  actions under Section 16(c) of
FIFRA, which states that the "district courts of  the United States are
vested with jurisdiction specifically to  enforce, and to prevent and
restrain violations of this Act."
Justification for Seeking Injunctive Relief
3he cour£« ^re %f^aexmlly .reluc^mt ^>  iMue ^mandatory injunctions or 'to
issue injunctions that will alter the  status quo except in the most
compelling instances.  Consequently, the Agency's need for injunctive
relief should be clear and unmistakable.  A permanent injunction should be
considered when:

     •  The Agency's administrative or other judicial enforcement remedies
        would be inadequate either at  restraining the violation or at
   - .  -  |.T»MIH-*IIB TmrrmTTrrmtflT Ttf*" tr Jimrnr rrr "fhr 
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Chapter Eight         	Injonctive Actions
A preliminary injunction or temporary restraining  order  should be
considered when the following additional elements  are  present:

     •  Immediate and irreparable injury, loss,  or damage will result if
        relief is not granted.  "Immediate"  is self-explanatory and is
        interpreted strictly; and

     •  There is likelihood of success at trial  based  on facts before the
        court (i.e., more than a 50 percent  chance of  winning at a trial
        based on facts before the court at the time of application).

Modern court trends have been to relax the requirement of irreparable
injury.  In particular, where a statute prohibits  certain conduct, many
courts will presume the conduct to be injurious  thus warranting an
injunction without requiring a showing of irreparable  Injury.  Ibis
doctrine has been applied to violations of the Federal Food, Drug, and
Cosmetics Act [U.S. v. Dlapulse Corp. of America,  457  F.2d 25 (2nd Cir.
1972)].  It Is reasonable to expect that the doctrine  can be extended to
apply to violations of FIFBA.  For instance, where there is a real
possibility of an "imminent hazard" to human health or the environment,
irreparable injury may not need to be shown.


Conditions That May Justify Injunctlve Relief

Injunctlve relief may be justified when:

     •  There is a violation of a Section 6  suspension order;

     •  There is a violation of an SSURO, where  a  civil  penalty or criminal
        prosecution would not provide a timely and effective enforcement
        remedy to deter further violations;

     •  There is continued production, shipment, sale, or use of an
        unregistered pesticide after the Agency  has taken civil or criminal
        action; or

     •  The Agency has exercised an enforcement  remedy and a person
        continues to make available for use  a restricted use pesticide
        other than In accordance with Section 3(d), or continues to use a
        pesticide in a manner Inconsistent with  its labeling or in a manner
        contrary to an experimental use permit.
Procedures for Seeking Injunctive Relief


1.   Determine the Necessity for Injunctlve Relief

     •  Regional Initiation.  The Regions generally make the initial
        determination that an injunction is necessary to restrain
      Compliance/mxorGement         8-18               Guidance **?**"•'  19B3

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Chapter  Eight     	Injunctive Actions
        violations  of  FIFRA or to prevent harm to humans and the environ-
        ment.   The  regional determination must be based on a careful weigh-
        ing  of  the  facts of the violation, of the evidence available to
        document  the severity of the violation, and of the justifications
        discussed above.

     •  Headquarters Initiation.  In some instances, Headquarters may be
        the  initiating party when noncompliance with the terms of the
        statute exists on a national level or the Registration Division has
        alerted PTSCMS to a situation that warrants an injunction.


     Determine  Type of Injunction To Be Sought

     •  Temporary Restraining Order (Exhibit 8-2).  A temporary restraining
        order (TRO), sometimes known as a provisional injunction, is
        limited and will expire In 10 days (but can be extended an addi-
        tional  10 days by the court).  It Is used when it can be shown by
        affidavit *vr'^T*'f*|»d*'re"p1 r*"* «•*«»*• -foj»»«i-t««-» and Irreparable
        Injury, loss,  or damage will occur before the time that the adverse
        party can present its case.  The purpose of the TRO is to preserve
        the  status  quo until a motion for a preliminary injunction can be
        heard.  Its advantage is that it is the most expediently obtained
        form of injunctive relief.

        Rule 65(b)  of  the Federal Rules of Civil Procedure (Fed. R. Civ.
        P.)  controls the procedural steps for obtaining a TRO.  Generally
        the  attorney for the adverse party, if known (or if not known, the
        adverse party  itself), must be given oral or written notice of the
        request for a  TRO.  However, this requirement is suspended if (1)
       . .It jiB shown hy SIM*pi fie facts that lawedl&te .•and 1 rrf iMirshlf harm
        ^•111 occsir «befor« the adverse party can :be iaeard and (2) If the
        government  attorney certifies in writing the efforts, if any,
        taken to  provide notice to the adverse party and the reasons
        supporting  the claim that notice should not be required.  The facts
        demonstrating  immediate and/or irreparable injury, loss, or damage,
        may  appear  either in a verified complaint or in a separate
        affidavit signed by an EPA employee other than the attorney for the
        case.  Along with the motion for a TRO, a copy of the suggested TRO
        should 
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Chapter Eight	Injunctive Actions
     •  Preliminary Injunction (Exhibit 8-3).  A preliminary injunction by
        its very nature is interlocutory, provisional, or temporary.  It is
        intended to preserve the status quo pending final determination of
        the action after a full hearing on the merits.  It is different
        from a TRO in that a preliminary injunction requires advance notice
        to the adverse party, and it can last longer than 10 days.

        Notice presumes a hearing and an opportunity to contest the motion
        for an injunction.  The applicant has the burden of establishing
        the right to injunctive relief.  To do so, it is advisable to rely
        on more than affidavits (Exhibit 8-4) whenever possible.  Oral
        testimony should be available when and if necessary to substantiate
        the Agency's contentions.

        At the hearing on the application for preliminary injunction, the
        court may order an advancement and the consolidation of the trial
        on the merits.  Consequently, the government attorney should be
        prepared to go forward with the prosecution of the case when
        seeking a preliminary injunction.

     •  Permanent Injunction (Exhibit 8-5).  A permanent Injunction, also
        called a final or perpetual injunction, is generally unlimited in
        duration.  It is usually granted only after a full trial on the
        merits.  Consequently, the judgment granting a permanent injunction
        constitutes final disposition of the suit, although the judgment
        may be appealed to a circuit court.

        Mere passage of time will not dissolve a permanent injunction,
        unless the judgment itself so provides.  However, the prospective
        features of a final injunctive decree are subject to termination or
        modification by the court when warranted by changed conditions.


3.   Determine the Appropriate District Court Having Jurisdiction

     The Regional Office must determine which is the appropriate district
     court having Jurisdiction over the violator.  An injunction operates
     In personam (meaning "against the particular person"), so that the
     dTstrict court in which the motion is filed must have in personam
     jurisdiction over the party against whom the injunction is sought.
     Usually this means that the person or corporation who Is the defendant
     must live or have a place of business within that State.  Service of
     process, or the delivery of written notice, In a district court is
     subject to the territorial limits of the State in which the court is
     located.  However, In some instances, an injunction may have an in rem
     ("against the world at large") effect on property or items that are
     the subject of the suit or that are within the court's in rem
     Jurisdiction,  jn rem jurisdiction may have a broader reach for
     serving process than does in personam—it is easier to get "the thing"
     than it is "the person."  These possibilities should be explored
     informally with the appropriate U.S. Attorney before formal referral
     of the case file.
      compliance/ mtor cr me at         o-zu              Guidance

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Chapter  Eight  	____^_	Injunctive Actions
4.   Prepare  the  Referral Package

     See  discussion In "Procedures for Filing Actions" (Section 3) in this
     chapter.
Court Actions  on Motions for Injunctlve Relief


If -an injunction is  granted, the following actions should ensue:

     •  Preparation  for the Next Stage of the Proceeding.  If the court
        grants a motion for a preliminary injunction or TRO, the regional
        attorney in  conjunction with the U.S. Attorney must begin prepara-
        tion for the next stage in the proceeding, whether that be a full
        trial  on the merits or a more extensive and permanent type of
        injunction.

     «  Monitoring the  Injunction. .  Although It is the court * s jresponsibil-
        ity to monitor  any equitable decree, including an injunction, the
        courts have  limited resources and often encounter practical diffi-
        culties in monitoring compliance.  If the court does not ask the
        Agency to monitor the injunction, the Region should offer to assist
        the court in monitoring the  injunction and to report any violations
        of the injunction.   A violation of an injunction will subject the
        party to a charge of contempt of court.

If an injunction is  denied, the Agency may either:

     •  Appeal the denial;  or

 -•-:-•-<•  Accept the denial ^and pursue other legal remedies.

In both Instances, the  Headquarters  Case Development Officer (HQCDO) should
be consulted by the  Regional Office  to determine which course of action to
take.
      compliance/Baxorceaent         8-21               Guidance •****•**»*  1983

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Chapter Eight	   Exhibit 8-2


                Model Motion for Temporary Restraining Order
                        United States District  Court

                                 District of
  (Title of Action)                  Civil Action  No.
                                     Motion for Temporary Restraining
                                     Order [With  or  Without Notice]
  Plaintiff, the United States of America, herewith moves this court to
  grant [*(!) forthwith and without notice to defendant for his attorney]
  a temporary restraining order restraining defendant,  his agents, and
  employees from (set forth acts sought to be enjoined) pending a hearing
  and disposition of plaintiff's motion for a preliminary injunction on
  the grounds that immediate and irreparable loss,  damage, or injury will
  result to (*(2) plaintiff, the public, the environment] as set forth in
  the attached verified complaint and affidavits  of (name of affiant)
  [*(3) before notice can be given] and before defendant or his attorney
  can be heard in opposition [*(4) as appears more  fully in the attached
  certificate of the undersigned showing that all reasonable effort has
  been made to notify the (defendant and/or his attorney) of this motion]<
                                         (Signature  of  U.S.  Attorney)
                                         United  States  Attorney for the
                                                  District of
  Date
  * (D»(3),(4) - These statements are optional  depending upon whether or
                  not the defendant or his  attorney receives advance
                  notice of the request  for a  TEX).

  * (2)         - The victim of the alleged Injury  can be best determined
                  from the actual facts  of  the case at hand.
FIPBA flH.jjp1 -Iamfei/'Ktfnff»sffitf              8—22

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Chapter Eight    	Exhibit 8-3


                    Model  Motion for Preliminary Injunction
                         United  States District Court

                                  District of
  (Title of Action)                   Civil Action No.
                                      Motion for Preliminary Injunction
  Plaintiff moves the court  for  a preliminary Injunction enjoining the
  defendant (name of defendant),  his  agents,  servants, employees, and
  attorneys and all persons  in active concert and participation with him,
  pending the final hearing  and  determination of this action, from (set
  forth act or acts sought to be  enjoined)  on the grounds that:
     XI)  Unless restrained  by tfa±s *eonrt  defendant will perform the acts
          referred to;

     (2)  Such action by  the defendant  will result in immediate and
          irreparable injury, loss, or  damage to (the plaintiff, the
          public interest, or the  environment),  as appears in the
          verified complaint and the  affidavit of (name of affiant),
          attached hereto; and

     (3)  The Issuance of a  preliminary injunction herein will not cause
          undue inconvenience or loss to defendant, but will prevent
                    an* ^T-apflT-aKlo -trvj.ii-y fn. fjjg plaintiff.
                                       (Signature of U.S. Attorney)
                                       Doited States Attorney for the

                                                 j&strict of
  Date
FUFKA Q»FPl •!»*»«• «*/RnfQT£^•^nt              8-23         Guidance n««m^i 1983

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Chapter Eight
                           Exhibit 8-4
      Model Affidavit in Support of Motion for Preliminary Injunction
                        United States District Court

                                 District of
  (Title of Action)
Civil Action No.
                                     Affidavit in  Support  of  Motion for
                                     Preliminary Injunction
  (Hame of Affiant)   , being duly sworn, deposes and  says:

  (1)  It [the United States] is the plaintiff in the  above-entitled
       action; and that it makes this affidavit in support of  plaintiff's
       motion for a preliminary injunction herein.

  (2)  This is an action [to enjoin defendant from engaging  in any
       violation of the Federal Insecticide, Fungicide, and  Bodenticide
       Act, as amended, 7 U.S.C. 8136 et seq.].

  (3)  [Statement of facts to support the motion].
                                          (Signature of Affiant)
     (ot
     gna
     her
                                                 than EPA attorney)
       Subscribed and sworn to and before me at (City and  State)
       	this	day of	, 19	.
                                     (Signature of Attesting Official)
Cot
&
                                            than EPA attorney)
                /ftnfnTi
   8-24
                               1983

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Chapter Eight	Exhibit 8-5


                   Model Motion  for Permanent  Injunction
                        United  States District  Court

                                 District  of
  (Title of Action)                  Civil Action  No.
                                     Motion  for Permanent  Injunction
  Plaintiff, the United States of America, herewith moves  the court to
  make permanent the preliminary Injunction  issued  herein  on (date).  In
  support, plaintiff submits  (the opinion of the court  of	)_
  which is conclusive to the  effect that the (behavior  or  activity"of the
  defendant) is unlawful and  no additional evidence could  alter that
  result.

     I optional:  (I)  Counsel may also want to Include  a paragraph-moving
                      the court to enter the mandate  of a  higher court,
                      if the  grant of injunction has  been  unsuccessfully
                      appealed.]

     [optional:  (2)  Counsel may also find  it necessary to  include a
                      motion  either for the dismissal of defendant's
                      counterclaim or for the grant of  summary judgment
                      as to the counterclaim.]
                                     (Signature of .U^.. -Attorney
                                     Jtaited States Attorney ,for the
                                                District  of
  Date
FIFRA Covpllance/Bnforcevent              8-25          Cn<^««rfi Manual  1983

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Chapter Eight
^XFMA uoapHanee/Enforcement              8-26           Galdance Manna1 1983

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Chapter Eight
5     In  Rem  (Seizure]  Actions
Statutory Authority
Section 13(b) of FIFRA authorizes the seizure, through  an in rem
condemnation proceeding in district court, of:

     •  Any pesticide that is adulterated, misbranded,  unregistered, not
        colored or discolored as required, or bears claims or directions
        for use that differ from those made in connection with its
        registration;

     •  Any pesticidal device that is misbranded; and
   -••--+  Any nestAclde or peytlcldal device *hat causes tmreastmable adverse
        effects upon the environment, even when used  in accordance with the
        requirements imposed under the Act.

Section 9(b) authorizes duly designated Agency employees  to obtain and
execute warrants for the purpose of seizing any pesticide or pesticidal
device that is in violation of the Act.
Enforcement Criteria


Seizure of a pesticide or device is effectuated through an in rem
condemnation proceeding conducted according to Rule 9(h) of the Federal
Rules of Civil Procedure (Fed. R. Civ. PO and.the Supplementary Rules for
                                     Ilitle 2BU.S.C.].  3he procedure to
initiate this judicial action requires more preparation and time than that
necessary to issue an SSURO.
FIFRA Compliance/Enforcement            8-27         Guidance Manual 1983

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Chapter Eight	In Bern Actions
Therefore, the SSURO is the preferred remedy in terms of  expediency.   A
seizure, nonetheless, should be considered when:

     •  An SSURO has been issued and is not being complied  with;

     •  There is reason to believe that an SSURO, if Issued,  would not be
        complied with;

     •  A pesticide is so hazardous that it should be removed from the
        marketplace or its place of use;

     •  It is necessary to support a recall; or

     •  It is necessary to dispose of products that remain  under  an SSURO
        without corrective action and for which there is  an expressed
        intent not to take corrective action by the person  holding the
        violative product.
In Rem Procedures
1.  Prepare the Referral Package

Upon determining that a pesticide or device is in violation of the Act and
that a seizure is the appropriate level of enforcement  action, the Regional
Office should prepare a civil litigation referral package (see Section 3 of
this chapter).  The package may include a proposed  complaint in rem
(Exhibit 8-6), which is prepared in accordance with Rule  C of the
Supplemental Rules for Certain Admiralty and Maritime Claims that accompany
the Fed. R. Civ. P.  The necessary elements of the  complaint in rem are
that:

     •  It be verified by oath or affirmation;

     •  It describe with reasonable particularity the property that is the
        subject of the action;

     «  It state that the property to be seized is  (or  will be during  the
        pendency of the action) within the jurisdiction of the district
        court that will hear the action;

     •  It state the place of seizure; and

     •  It state the allegations of the violations,  as  required by the
        statute, with sufficient particularity that  the defendant/
        respondent can frame responsive pleadings and investigate the  facts
        without moving for a more definite statement.
FIF1A GoBpliance/Enforceaent             8-28          Guidance Manual  1983

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 Chapter  Eight            	In Eat Actions
 2.   Execute  the Warrant

 Once the complaint in rem is filed with the court, an "arrest" warrant
 (i.e.,  a warrant for the arrest of the property that is the subject of  the
 action) will be issued.  According to Rule C(3) of the Supplemental Rules,
 the  warrant  is delivered to a U.S. Marshal for execution.  However, Section
 9(b) of the  Act provides that duly designated EPA employees are authorized
 to obtain and execute warrants for the purpose of effecting a Section  13(b)
 seizure.  It is the Agency's view that a seizure warrant may be served  by
 either  a U.S. Marshal or an EPA employee.  These possibilities should be
 brought to the U.S. Attorney's attention, and the .Region should make known
 its  preference.  However, the Region should abide by the wishes of the
 U.S. Attorney if it Is preferred that the U.S. Marshal serve the warrant.


 3.   Notify Other Regions

 The  Region should notify other Regions of its actions if there is reason to
 believe that the violative product is also in those Regions.
Compliance With  a Seizure
The violation  of  a court-ordered seizure or decree of condemnation consti-
tutes contempt of court.  When any such violation is found, it should be
reported  promptly to the U.S. Attorney who filed the seizure action.
Ittyppsltlon of a Seizure
While  pesticides  or pesticidal devices under seizure are in the control of
the court,  the  Regional Office will usually be called upon to recommend or
approve  the method  of disposition and may be directed to supervise the
court-ordered action In decrees of condemnation.  When agreeable to the
U.S. Attorney,  the  Regional Office should prepare the proposed consent or
default  decree  to be filed by the U.S. Attorney.


Reconditioning

Where  disposition is achieved by reconditioning, the person supervising the
reconditioning  under a consent decree should report the method of
reconditioning, what examinations or tests were made, and whether the
pop*"jf r^f*** nr" :Jf ptffiA&1  dfVlCP is .HOW. .In *»
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Chapter Eight     	                               In Bern Actions
Agency Reimbursement

Because the Agency will be reimbursed by the claimant  for expenses incurred
in the seizure, the Region should keep a record of all expenses  incurred in
connection with the supervision and disposition of the seized products.
The schedule of expenses should be attached to the report of  supervision
and presented to the U.S. Attorney for collection concurrent  with the
payment of court costs (Exhibit 8-8).
FIFKA GbBpliance/Enforceaent              8-30           Gnldft^r* M^M">1  1983

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Chapter  Eight	Exhibit 8-6


                            Model Complaint In Bern
                  IN THE UNITED STATES DISTRICT COURT  FOR THE
                                  DISTRICT OF
  United  States of America
                                                         Complaint  In Rem
  TO THE HONORABLE JUDGE OF SAID COURT:

  This  is  a  complaint in rea filed in behalf of the United  States  of
  America  by the  United States Attorney for this District,  who  represents
  This  is  an  action in rem instituted pursuant to Section  13(b)  of  the
  Federal  Insecticide, Fungicide, and Rodenticide Act, as  amended,  7
  U.S.C. Sl36k(b),  for the seizure for confiscation by a process in rem
  for condemnation  of (name of the product in the caption), a product
                                       or Inrorted aa ,.a -.(pestlf* ^° ,-or
  jdrtlce ) within the •iiininc nf Section 2 of tfae Ifedexal Insecticide.
  Fungicide, and Rodenticide Act, as amended, 7 U.S.C. §136.  Authority
  to bring  this action is vested in the United States Attorney by 28
  U.S.C. $547(2).

                                      II

                                       vWi^r* r:iwxfffT J~iff ••'4_ti9 action
                                     7 ^J^S.C
FIFRA Govpllance/Enforceaent             8-31         Guidance ^*tmai 1933

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Chapter Eight              	&hibit 8-6
                                     III

  On or about                                                      ,19
  the product was (transported, imported,  sold,  offered for sale) by "
                                            from
  to
  and the product remains unsold or  in  the  original unbroken packages and
  is now in the possession of (person in possession and exact location)
  or elsewhere within the jurisdiction of  this  Honorable Court.


                                      IV

  The product is labeled, marked, and branded  (in part) as follows:
  The product is in violation of  the Act  as  follows:

         (State allegation with specific  reference to unlawful acts)
PIFBA Qmplisaee/Enforceaent              8-32          Goidance «a»««"ai  1983

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Chapter Eight    	  	      	Exhibit 8-6
  WHEREFORE,  in  consideration of the premises,  the complainant, United
  States of America,  prays:

  (a)  That the  pesticide/device, 	be  proceeded against and
  seized for  condemnation and confiscation,  and that it be disposed of as
  the Court may  direct  in accordance with the provisions of Section 13(b)
  of the Act  [7  U.S.C.  Sl36k(b)] and in conformity with the practice of
  this Court, and  that  the parties  specified in paragraph II of this
  complaint 'and  any and all  other persons having or pretending to have
  any right,  title, or  interest  in  and  to the product be notified to
  appear herein  in order that they  may  answer all and singular the
  allegations herein  set forth.

  (b)  That this Honorable Court may enter all  such orders, decrees, and
  judgments as may be necessary  in  the  premises to grant further relief
  to your complainant and for the costs of this proceeding should such
  costs not be satisfied out of  the proceeds of the sale of the product,
  jj this v^onorable Court should decree; the  same to be sold.

  (c)  That your complainant may have such other and further relief as
  the nature  of  the case may require.

                                      (Signature of U.S. Attorney	
                                      United States  Attorney for the

                                                 District of
                                 VERIFICATION

  T "have read the  foregoing pleading and know Its  contents;  vhich is true
  and correct of my  own  knowledge,  except as to matters  therein stated
  upon my information  and  belief, and as to  such matters I believe it to
  be true.
  Executed on this	day  of  (date)

  (location)	
                                      Halted  States  Attorney
FIFRA Compliance/Enforcement              8-33          Guidance MMIM*!  1983

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Chapter Eight	Exhibit 8-7


                 Model Report of Supervision of  Disposition
                UNITED STATES ENVIRONMENTAL  PROTECTION AGENCY
         REPORT OF SUPERVISION OF DISPOSITION  OF  PESTICIDE OR DEVICE

  Pesticide or Device Detained Under
                             (Stop Sale, Etc.,  Order,  Seizure by Marshal;
 (EPA Seizure (warrant); Voluntary Recall;  Give  Place and Date of
 Detention)
       (
  Sample No., I.F.&R. No., Court No._

  Name of Pesticide or Device

  Nature of Violation
  Type of Disposition Order or Agreement
                                         (Consent  Decree;  Voluntary
  Reconditioning; Court-Ordered Destruction;  Etc.)

  Method of Disposition
                       (Reformulate;  Relabel;  Destroy;  Etc.)



  Results of Disposition Action	
                               (In Compliance - Relabeled;  Etc.)
  (Not in Compliance - Ineffective by Test;  Etc.,  Give Test Results,.Etc.)

  Further Action Required	
                        (None or, Further  Reformulation;  Relabeling; Etc*)
  Remarks
                                     (Signature  and Title of EPA Employee)
                                      (Place and Date)
FIFRA Qa»pi -taTwo/nnf«i-f n»QTif              8-34          Guidance Manual 1983

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Chapter Eight
                         Exhibit 8-8
                        Model Expenditure Report Foi
                UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
        CHARGES FOR SUPERVISION OF DISPOSITION OF PESTICIDE OR DEVICE
                     (Attached to Report of Supervision)

  Sample No., I.F.&R. No., Court No.	

  Name of Pesticide or Device
  Amount of Pesticide or Device_

  Method of Disposition	
  Types of Charges
 Unit
           Charge   Total
                              Hours
Days
Miles
  Inspector Time
  Analyst Time
  Inspector Per Diem
  Analyst Per Diem
  Inspector Automobile Use
  Analyst Automobile Use
  Other Transportation or
  Miscellaneous Expenses
  (Itemize)
         Sub-Totals
         Grand-Total
  Remarks:
                                     (Signature of Inspector or Analyst)
 FIFRA CompUance/Enforceaent
  8-35
Gi
                       1983

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  Chapter  Eight
                                                                      Exhibits
FIPRA Qompl 1 ance/Eoforceaent
8-36          Guidance Manual 1981

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Chapter Eight
6    Settlement Agreements
By their very nature,  FIFRA civil actions do not involve settlement
agreements.  Nonetheless, an injunction or :dn rem (seizure) action that
is granted 'to EPA *by a district court -is also usually monitored for
compliance by the Agency.  The violation of either type of civil action
will subject the responsible party to a charge of contempt of court.
FIFRA Compliance/Enforcement           8-37

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Chapter Eight                                          Settlement Agreements
FIFRA Compllance/Enforcement             8-38           Guidance Manual 1983

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Chapter  Nine
Judicial Enforcement:   Criminal  Actions
Chapter Contents  	Page
Statutory Authority                                           9-1
Basic "Enforcement Policy                                      9-1
Criteria for Identification of a Potential Criminal Action          9-2
Procedures for the Investigation and Referral of a Criminal Case     9-6
Exhibit 9-1:  Criminal Enforcement Divisions:  Field Offices        9-10
Exhibit 9-2:  Memorandum (9 May 1983):  Referral Procedure for
            Criminal Cases                                   9-11
Exhibit 9-3:  Uniform Criminal Referral Package Format             9-16
F.LFKA cmpJaance/ianxorceaent           y-i          Guidance Manual 1983

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Chapter Nine
                                          Contents
VlFRA  CJownllance/Bafoi
                     ort
ant
                9-1]

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 Chapter  Nine
Judicial  Enforcement:  Criminal  Actions
 Statutory Authority
 Section 14(b) of FIFRA provides the following criminal penalties for the
                  *' - of ~-v*y provision of  the Acts
      (1)  In General. — Any registrant,  commercial applicator,
          wholesaler, dealer, retailer, or other distributor who
          knowingly violates any provision of this Act shall be
          guilty of a misdemeanor and shall on conviction be
          fined not more  than $25,000,  or imprisoned for not
          more than one year, or both.

      (2)  Private applicator. — Any private applicator or other
          person not included In paragraph (1) who knowingly
          violates any  provision of this Act shall be guilty of a
          •isdeneznoT .and shall on conviction *e fined not more
          •than "$ 1 ,000 ,  vr imprisoned ^f or- -not TBOT« than 30 ^lays ,
          or both.

 Section  12 of FIFRA enumerates those acts considered unlawful under the
 Act  (see Chapter Seven  for a complete listing.)
      Bttforceaent Policy


 The objective of the pesticides enforcement program is to  ensure compliance
 with  the terms and provisions of FIFRA.  The Act provides  the Agency with a
 variety of administrative, civil, and criminal enforcement options to
 accomplish this goal.  A broad range of  potential overlap  exists among
                     *  . Thf oirt j <*n] 1 j at - Apyf j — £he -Agency- j A -.free to
 FIFRA GoBpllance/Biforcement   :         9-1           Guidance Manual 1983

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Chapter Nine	Criminal Enforcement
pursue criminal sanctions in every situation presenting  evidence  supporting
the requisite elements of proof.*

As a matter of enforcement policy and resource allocation,  such an
unrestrained use of criminal sanctions is neither warranted nor practical.
The commitment of investigative and technical resources  necessary for  the
successful prosecution of a criminal case is high.  More Importantly,  a
criminal referral for investigation or prosecution can entail  profound
consequences for the subject of the referral.  Accordingly, criminal
referrals should be confined to situations that reflect  the most  serious
cases of environmental misconduct—when measured by the  nature of the
conduct, the compliance history of the subject, or the gravity of the
environmental consequences.
Criteria for Identification of a Potential Criminal Action
This section discusses the considerations that should  be  examined  in
determining whether to proceed with a criminal vis-a-vis  administrative/
civil action.
The Scienter Requirement

An Individual who engages in conduct prohibited by  statute or regulation
can be prosecuted civilly or administratively without  regard to the  mental
state that accompanied the conduct.  Criminal sanctions,  on the other hand,
will be limited orginarily to cases in which the prohibited conduct  is
accompanied by evidence of a "guilty knowledge" or  intent on the part of
the prospective defendant.  Referred to as the scienter requirement, this
element of proof exists under virtually every environmental statute
enforced by the Agency.**
*  Pesticide use of FIFEA violations are an exception  to  this  general
   statement.  Sections 26 and 27 of FIFRA establish standards and
   procedures for according to the States the primary  enforcement
   responsibility (primacy) for pesticide use violations.   Where a State
   has primacy, the Agency will not bring an enforcement  action unless  the
   State is unwilling or unable to address the situation.   If  the State has
   referred the matter to the Agency, the Agency will  proceed  as with any
   other case under FIFRA.

** One exception to this general rule is the Refuse Act,  33 U.S.C. 1407,
   which has generally been interpreted as a "strict liability" statute.
   [See, e.g., United States v. White Fuel Corporation. 498 F.2d 619 (1st
   Cir. 1974).]  In addition, a prosecution for illegal discharges under
   the Clean Water Act can be based on negligent or willful conduct, 33
   U.S.C. Sl319(c)(l).  "Negligence" is not, strictly  speaking, a form  of
   scienter.
FIFRA Coapllance/Eoforeeaent            9-2             Guidance Manual 1983

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 Chapter Nine	Criminal Enforcement
 Under FIFRA, criminal penalties are imposed only for  "knowing" violations
 of the Act.  The term "knowing" has been used in a number of other criminal
 provisions and has been interpreted to mean that the violative act must be
 done intentionally and not as a result of accident or mistake.

 To date,  only one case has addressed the meaning of the word "knowing" as
 it is used in FIFRA.  In United States v. Corbin Farm Services, 444 F.
 Supp. 510 (E.D. CA. 1978), the defendants were charged with the knowing use
 of a registered pesticide in a manner Inconsistent with its labeling.  The
 label on  the pesticide in question stated:  "For water fowl protection do
 not apply...on fields where water fowl are known to repeatedly feed."  The
 defendants had applied this pesticide to a field containing evidence of
 bird activity, which resulted in the death of migratory birds.  The court
 found that in order to prove knowing activity, the government must show a
 general intent on the part of the defendants to do the act in question
 (i.e., the government was required to show that the defendant knew that he
 was using a pesticide when he sprayed the field).  Proof of intent to
 violate FIFRA was not necessary.

 The ^requirement to prove a culpable mental .atate, -as well as a prohibited
 act,  is certainly the clearest distinction between criminal and
 administrative/civil enforcement actions.
 The  Nature and Seriousness of the Offense

 As a matter of enforcement policy and resource allocation, EPA will
 investigate and refer only the most serious forms of environmental
 misconduct for criminal prosecution.

 Of primary importance to this assessment is the extent of environmental
 ITMIf TIT'*'***^ ^ *"""  **** "^BBy* ^•»«T*fc fn^TT d tttft h&S ''rmm*?'\'*T$ "fTCTl^ Or 088
 threatened by, the prohibited conduct.  In general, this determination will
 depend upon considerations such as the duration of the conduct; the
 toxicity of the pollutants involved; the proximity of population centers;
 the  quality of the receiving land, air, or water; the amount of Federal,
 State, or local cleanup expenditures; and public sentiment supporting
 strong enforcement action in response to a specific situation.
is of  particular importance in cases of the falsification or concealment of
records,  reports, or other Information.  For example, even if a technical
falsification case can be made, criminal sanctions may not be Appropriate
if the distortion of information could not reasonably have been expected to
have a significant impact on EPA's regulatory or decisionmaking process;
However,  where the impact is material, as in the case where the
falsification activity aright can»e £PA to ^register m pesticide with
*4cnons Li aled cai clnogenic potential , ^^tg 'TiBBi8 ••fair •
be considered.
FIFBA Compliance/Enforceaent            9-3            Guidance Manual 1983

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Chapter Nine	Criminal Enforcement
The Need for Deterrence

Deterrence of criminal conduct by a  specific  individual (individual
deterrence) or by the community at large  (general  deterrence) has always
been one of the primary goals of criminal law.   Where the offense is
deliberate and results in serious environmental  contamination or human
health hazard, the need to achieve deterrence through the application of
strong punitive sanctions will almost always  exist.

The goal of deterrence may, on\>ccasion,  justify a criminal referral for an
offense that appears relatively minor.  This  would be true, for example,
for offenses that—while of limited  importance by  themselves—would have a
substantial cumulative impact if commonly committed.   This might also be
true when addressing violations by an individual with an extended history
of recalcitrance and noncompliance.


The Compliance History of the Subject(s)

The compliance history of the subject of  a potential  criminal referral also
should be considered in determining  the appropriateness of criminal
sanctions.  As a general rule, criminal sanctions  become more appropriate
as the incidents of noncompliance increase.   The occurrence of past
enforcement actions against a company or  the  failure  of administrative/
civil enforcement, is certainly not  a prerequisite to a criminal referral.
However, a history of environmental  noncompliance  will often indicate the
need for criminal sanctions to achieve effective individual deterrence.
The Need for Simultaneous Administrative/Civil or Enforcement Action

Simultaneous administrative/civil and  criminal enforcement proceedings are
legally permissible, United  States v.  Kordel,  397 U.S. 1, 11 (1970), and on
occasion are clearly warranted.  However,  separate litigation staffs would
need to be appointed on  initiation of  a grand  jury investigation, if not
before.  Furthermore, the pursuit of simultaneous proceedings would provide
fertile grounds for legal challenges to one or both proceedings that, even
if unsuccessful, would consume additional  time and resources.  Thus,
parallel proceedings should  be avoided except  where clearly justified.

In this regard, it should be noted that some of the goals of a criminal
prosecution, including deterrence, can be  achieved through an
administrative or civil  action that secures substantial civil penalties in
addition to injunctive relief.  Moreover,  recent experience indicates that
while some eases may result  in periods of  Incarceration, criminal sentences
will often be limited to monetary fines and a  probationary period.  In
light of this reality, the use of the  additional time and resources
necessary to pursue a criminal investigation is often not justified.
FIFRA Cn^pi < «Mii"*/Hnf orrrmcnt             9-4            Gnida"?* Manna 1 1983

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 Chapter Nine	Original Enforcement
 Criminal Enforcement Priorities

 The Criminal Enforcement Division, in conjunction with the Agency program
 offices, has developed investigative priorities in each of the Agency's
 program areas.  The purpose of this effort is to focus the limited
 investigative resources of the Agency on the most serious cases of
 environmental misconduct.  These priorities are fluid and will be modified
 to reflect additional regulatory programs in the Agency as they develop.
 In addition, the creation of these priorities does not preclude the
 possibility of criminal. referral for conduct not falling within these
 Investigative priorities .

 The order of listing is random.  It is not Intended to create a ranking
 within the priorities for a statute.  Nor is any statute given higher
 priority than another.  The priorities for FIFRA are listed below.

 Failure To Report Information on the Unreasonable Adverse Effects of a
 Registered Pesticide:  Section 14(b) of FIFRA, 7 U.S.C. §1361(b),
                                £$ -for the knowing violation .of any
•provision of ±he Act.  'Section T2Ca)(2)(N). provides 'that it is unlawful to
fall to submit information required by Section 6(a)(2).  This section
requires a registrant to report to EPA any information that the registrant
obtains after  the pesticide is registered regarding unreasonable adverse
effects of the pesticide on the environment.  A high investigative priority
will be placed on knowing violations of this reporting requirement.

Falsification  of FIFRA Records.  Sections 12(a)(2)(M) and 14(b) of FIFRA, 7
U.S.C.  SSl36j(a)(2)(M) and 1361(b), establish misdemeanor penalties for the
knowing falsification of specified records maintained or filed under FIFRA,
Including registration data.  A high investigative priority will be placed
                  .«*•«• <•»< fry frhaf tma—  of TOFSA, 7
 U.S.C.  SSl36J(a)(2)(G) and 1361(b), establish misdemeanor penalties for the
 knowing use of a pesticide in a manner Inconsistent with its labeling.  If
 FJJTKA uompJJLance/ Bozorcement            9-5            Guidance Manual 1983

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Chapter Nine	Original
referred by a State with primary use enforcement responsibilities,  a high
investigative priority will be assigned to misuse cases  that  result in,  or
threaten, significant environmental contamination or human health hazard.

Illegal Distribution of Unregistered Pesticides.  Sections 12(a)(l)(A)  and
14(b) of FLFRA, 7 U.S.C. SSl36j(a)(l)(A) and  1361(b),  establish misdemeanor
penalties for the knowing distribution, receipt, etc.  of an unregistered
pesticide.  The pesticide registration process outlined  in Section 3 of
FIFRA, 7 U.S.C. Sl36a, is the cornerstone of  EPA's  program to monitor and
regulate the safety of pesticides.  A high investigative priority will  be
placed on illegal transactions involving unregistered  pesticides that
result in, or threaten, significant environmental contamination or human
health hazard.
Procedures for the Investigation and Referral of a  Criminal  Case	


Investigation

The Criminal Enforcement Division maintains the primary  role in the
investigation and referral to the Justice Department  of  allegations of
criminal misconduct.  The division is staffed by experienced criminal
Investigators located in each of five area offices  and EPA Headquarters.
(Exhibit 9-1 contains a list of the division's area offices  and their scope
of responsibility.)

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, disgruntled plant employees,  or  citizen groups.
Regardless of its source, it should be transmitted  immediately to  the
Special-Agent-In-Charge of the responsible field office, who will  open  a
case file* and assign a criminal investigator (known  as  a Special  Agent)  to
the lead for follow-up.

If the reliability of the lead is unclear, the Special Agent will  conduct a
preliminary inquiry solely to determine the credibility  of the allegation
and to make an Initial assessment of the need for more thorough
investigation.  This initial inquiry will be brief  and will  not involve
extensive commitment of resources or time.  Its sole  purpose is to reach  an
initial determination on the need for a complete investigation.
* The opening of a case file does not commit  the Agency to proceed with a
  criminal referral at the culmination of the investigation;  nor does  it
  reflect an Agency decision that criminal  conduct  has  occurred. All
  enforcement options remain open and should  be considered until referral
  to the Justice Department.
feUFJLA tiaapliasice/Snforceaent1F6             QaLAanrr Manual 1983

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 Chapter Nine                	        Criminal Enforcement
 Once a determination has been made by the Criminal Enforcement Division
 that a thorough investigation is warranted, the Special Agent will
 immediately contact the Regional Counsel in the Region where the
 investigation is to be conducted.  The Regional Counsel will ensure that no
 civil enforcement action is pending or contemplated against the
 Investigative target and will assign an attorney to work with the
 Investigator during the case development process.  The regional attorney
 and Special Agent will also contact the appropriate regional program office
 to ensure that no administrative enforcement action is pending or
 contemplated.  In addition, where the need for technical support during the
 Investigation is contemplated, the regional program office will be asked to
 assess the availability of technical resources and, when appropriate, to
 designate a specific Individual to work with the Special Agent during the
 course of the investigation.

 While simultaneous administrative/civil and criminal enforcement actions
 are legally permissible, they will be the exception, rather than the rule.
 As a general rule, an administrative or civil proceeding will be held in
 abeyance pending the resolution of the criminal investigation.  One
 exception to this general rule will be those situations in which emergency
 remedial response is mandated.  In these situations, however, the criminal
 investigation will not be initiated without the prior approval of the
 appropriate Regional Counsel and Enforcement Counsel.

 Management of the Investigation will be the primary responsibility of the
 Special Agent, acting under the supervision of the Field Office
 Special-Agent-In-Charge.  The Special Agent will be responsible for
 determining the basic investigation approach and will take the lead in
 conducting interviews; assembling and reviewing records; planning and
 executing surveillances; coordinating with State, Federal, and local law
 enforcement agencies; planning and executing searches; developing
 Informants; ?and performing otter Investigative matters.  A technical person
 •wHT-workTrLtfc the Special Agent dnriiig those portions of an Investigation
 requiring technical expertise.


 Notice of Contemplated Proceedings

 Section 9(c)(l) of FIFRA requires the Agency to give notice and an
 opportunity to be heard to those persons* against whom enforcement
TTwr^Bil'l IIIBT t -'mAldi 4zlse'- '.&• a.Tevolt 
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Chapter Nine	Criminal Knfor
Referral

A referral recommendation will be developed when the  independent field
investigation has been exhausted, or when it  can or should proceed no
further without the initiation of a grand jury  investigation by the Justice
Department.  Where a referral is made  for further investigation by a grand
jury, the task of creating a complete  referral  package is difficult since
the case has not yet been completely developed.   Therefore,  a streamlined
ferral process has been initiated for  these cases to  eliminate inefficiency
and to provide for the more natural development  of criminal  cases.  See
Exhibit 9-2 for a copy of these procedures.   At  this  point,  the results of
the investigation will be assembled in a referral package.  The preparation
of the overall referral package will be the responsibility of the regional
attorney assigned to the investigation, working  in conjunction with the
Special Agent.

Once the package is prepared, it will  be reviewed by  the S pedal-Agent -
In-Charge and the Regional Counsel, who will  act as joint signatories.
Technical portions of the package will also be  reviewed by the regional or
Headquarters program office, or the NEIC—depending on the source of
technical support.  During this technical review, the availability of
technical resources to support litigation should also be reviewed and
specifically confirmed by the appropriate technical office.

Following completion of the referral package  and concurrence in the
referral recommendation by the Special-Agent-In-Charge and the Regional
Counsel, three copies of the referral  package and all exhibits should be
directed to the Associate Enforcement  Counsel for Criminal Enforcement,
Criminal Enforcement Division (LE-134E), U.S. Environmental  Protection
Agency, 401 M Street, S.W., Washington D.C. 20460. No copies of the
referral package will be sent to the local United States Attorneys Office
or the Justice Department until Headquarters  has reviewed and approved the
referral.

If either the Special-Agent-In-Charge  or the  Regional Counsel believe the
referral should not be made, that official will  Include a statement of the
reasons underlying this position and make an  alternative recommendation
(i.e., close out investigation, change to civil  referral, change to
administrative action, etc.).  The package will, nevertheless, be directed
to the Criminal Enforcement Division for review; a final referral decision
will be made by the Associate Administrator for  OLEC  (or the Associate
Administrators designee).

The Headquarters review will focus on  the adequacy of case development;
adherence to the criminal enforcement  priorities of the Agency; legal
issues of first impression; consistency with  related  program office policy;
and general prosecutorial merit.  In cases Involving  particularly complex
issues of law, the Criminal Enforcement Division will also consult with
General Counsel attorneys.  If, following this  review process, the referral
recommendation is accepted, referral packages will be directed simulta-
neously to the Justice Department and  the appropriate United States
Attorneys Office.  Appropriate cover letters  will be  drafted by the
Criminal Enforcement Division.
FXFRA £m«pllaiice/K"*oTre?m'p"«'             9-8             Guidance *«•""*1  1983

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Chapter Nine	Cr*«rf«*i  Enfor
Referral Package Format

Referral packages  should be prepared  in accordance with the Uniform
Criminal Referral  Package Format  effective on January 1, 1982.   (See
Exhibit 9-3.).  However, referral packages prepared for those cases
referred for further  investigation by a grand Jury should be prepared in
accordance with the Hay 9, 1983 guidance concerning referral procedure for
criminal cases (see Exhibit 9-2).


References

Agency employees Who  are involved in  the investigation and referral to the
Department of Justice of allegations  of criminal violations of  FIFRA should
familiarize themselves with the Agency documents listed below.   Although a
digested form of some of this material is contained in this section, most
of the items are not  covered in detail.  The documents are contained in the
General Enforcement Policy Compendium,  or copies of the documents may be
                f*^ "P v--tbe' £ridsal Enforcement Division* RP^ .fleadouarters •
     •  General Operating Procedures  for the Criminal Enforcement Program
        (October 31,  1982);

     •  Criminal Enforcement Priorities;

     •  Agency Guidelines for Participation in Grand Jury Investigations;

     •  Agency Guidelines for the Use of Administrative Discovery Devices
        in  the Development of Potential  Criminal Cases;

     •  Policy and  Procedures  on Parallel Proceedings at the EPA.

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Chapter Nine
                              Exhibit 9-1
               Criminal Enfor
t Divisions:  Field Offices
    Philadelphia Field Office
    (Regions I, II and III)

    Special-Agent-In-Charge
    Criminal Enforcement Division
    EPA - Region III
    Curtis Building
    6th & Walnut Streets
    Philadelphia, PA  19106
    PTS 597-1949
    Atlanta Field Office
    (Regions IV and VlT~

    Special-Agent-In-Charge
    Criminal Enforcement Division
    EPA - Region IV
    345 Courtland Street, N.E.
    Atlanta, GA  30365
    PTS 257-4885
    Chicago Field Office
    (Regions V and VII)"

    Special-Agent-In-Charge
    Criminal Enforcement Division
    EPA - Region V
    230 South Dearborn Street
    Chicago, IL  60604
    PTS 886-9874
   Seattle Field Office
   (Regions IX and xT

   Special-Agent-In-Charge
   Criminal Enforcement Division
   EPA - Region X
   1200 6th Avenue
   Seattle, WA  98101
   PTS 399-9874
   Denver Field Office
   (Region
   Special-Agent-In-Charge
   Criminal Enforcement Division
   National Enforcement Investigations
     Center
   Box 25227
   Denver Federal Center
   Denver, CO  80225
   PTS 234-2158
    * The Denver Field Office is located at the National Enforcement
      Investigations Center.  In addition to Region VIII cases,  its
      responsibilities include cases that overlap the Jurisdiction of
      field offices.  Assignment of these cases will be the  responsi-
      bility of EPA Headquarters.
FIFRA Go*pliance/Enfor
       9-10
Guidance Manual 1983

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 Chapter Nine	Exhibit 9-2



                     Referral Procedure  for Criminal  Cases
                  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                WASHINGTON.
                                  MAT  9BS3
                                                               i CM>»m.i«iiMT
       MEMORANDUM

       SUBJKCTs  Referral Procedure  for Criminal Cases

       ntOMs     Courtney M.  price (\CuJ^ ^ .w
                 Acting Associate Administrator
                               'Counsel
       TO*       Regional Counsels, Regions I-X
                 All SAZCs, Criminal Enforcement Division


            Onder the current General Operating procedures,  a
       criminal referral to the justice Department may  be made  for
       one of two reasons) for prosecution (where the investigative
       effort is complete and we believe the crime is capable of
       being proved); and for further investigation  in  conjunction
       with the Justice Department.

            In the latter situation—"referrals for  further
       investigation*—the scope of the ultimate prosecution, and
       even the identity of defendants, may well not be known.  The

       •of ^iie case xattwr ^ttosn -tto -.jJicurporsta «£iaal ••Agency oacisioni
       on the viability or advisability of a prosecution.  As such,
       it can and often does occur at an early stage in the  case
       development process.

            In these 'situations, the task of creating a complete
       referral package is difficult—in light of the fact that the
       ease has not yet been completely developed.   Zt  is also  time
       consuming, and thus can prejudice the investigation.  The
       time spent in attempting to prepare a complete referral
                                                          fcegJa«*i
                                         i, "
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Chapter Nine
                        Exhibit  9-2
                    Referral Procedure  for Criminal  Cases
                                    -2-

            To eliminate this inefficiency, and provide for the more
       natural development of criminal cases, a shortened referral
       package will be used where the purpose of the referral is
       for further investigation in. conjunction with the Justice
       Department, rather than to incorporate a complete investigative
       package.  (The format appears as Attachment A.)

            This package will provide a basis on which to make the
       best possible assessment both at the Regional level and at EPA
       Headquarters on the merits of the potential case.  'At the
       same time, it will provide a vehicle for the more rapid
       transmission of our investigative work product to prosecutors
       with the Justice Department, who will then become part of the
       criminal case development team.

            The modified referral package will normally be prepared
       by the Special Agent assigned to the investigation, who will
       be most familiar with investigative activity to date.  The
       package must be prepared in close coordination with Regional
       legal and technical personnel assigned to the investigation.
       As under existing procedures, the referral will be approved by
       both- the Special-Agent-in-Charge and the Regional Counsel
       before transmission to EPA Headquarters for approval.  Cover
       letters to the appropriate United States Attorney and to the
       Land and natural Resources Division will be drafted at EPA
       Headquarters, for the signature of the Associate Administrator.

            Questions on this procedure should be directed to
       Peter Beeson (382-4543).   It is our hope that these modified
       procedures will ensure the most efficient possible development
       of our c-  "inal cases.

       Attachments
 FIFRA Compliance/Enforcement
9-12
Guidance Manual 1983

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Chapter  Nine	ggfaibit 9-2

                    Referral Procedure  for Criminal Cases
                                ATTACHMENT A
             r
        KEMORANDOM
        FXDM:      Special-Agent- in-Charge
                                       Field Office
                 Criminal Enforcement. Division
                 Regional Counsel
              ,  Region
       THRO:
                 Associate Enforcement Counsel
                 Criminal 'Enforcement Division
                 Enforcement Counsel

       TOi         -  .	
                 Associate Administrator and General Counsel

            Attached for your consideration are aaterials assembled
       by this Agency in a criminal investigation against	
                                     It i» tte fiplaian «f oar off!
       that further development of this case should proceed in
       close coordination with the- Justice Department.  An overview
              •  »
       of the nature of this investigation is provided below for
       your information.  We recommend immediate referral to the
       (O.S. Attorney/Federal District) and to the Land and Natural
FIFRA Qmpllance/Eoforc^nt              9-13         Guidance Mana*X_1583.

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Chapter Nine	Exhibit  9-2



                    Referral Procedure  for Criminal Cases
                                REFERRAL PACKAGE
                                 (Mane of Case)
                               (Hame of District)
          Z.  Identity of Subjeet(s) of Investigation*

              Individual(a)i

                   1. -Not*
                   2.  Title
                   3.  Age
                   4.  Borne/work address
                   5.  Currant employment
                   6.  Criminal record,  if any
                   7.  Prior EPA enforcement action
                   8.-  Other partinant information


              Corporation(s)i
                   1.  Base and nature of business
                   2.  Parent company
                   3.  Susidiaries
                   4.  Address of faeility(ies)  associated
                       with offenses
                   S.  State of incorporation
                   4.  Size of company
                   7.  Prior EPA enforcement action
                   t.  Other pertinent information
                 , •

         II.  Nature of Activity under Investigation

                   1.  Location and duration
                   2.  Venue
                   3.  Significance of Activity  (A brief  statement
                       of reasons underlying the need to  address
                       the misconduct with criminal sanctions.)
FIFRA  Compliance/Enforcement              9-14          Guidance Manual 1983

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Chapter  Nine	Exhibit  9-2



                    Beferral Procedure for CrlavLnal Cases
                                    -2-
        XZZ.   Statutory Offenses
                 l/~ Applicable Statutes;  (A summary of Federal
                     environmental «n3"~related laws potentially
                     violated by the activity, accompanied by
                     pertinent citations to th* United States
                     Code and the Code of Federal Regulations)

                 2.  evidence Gathered to Bate: (A brief summary of
                     available evidence, accompanied-%y copies  of
                     selected investigative reports prepared within the
                    . Criminal Enforcement Division that reflect this
                     evidence (for example, surveillance reports or
                     Jjterview summaries.)
       XV.  Personnel Assigned
                 1.  Special Agent
                 2.  Regional Attorney
                 3*  Technical Staff
FXFRA Compliance/Enforcement              9—15         Guidance M«MMI 1983

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Chapter Nine	    	Exhibit  9-3
                                                                     Page
           VI.  Legal Issues 	
          VII.  Environmental Impact	
         VIII.  Becommendation	
   Appendix A.  List of Witnesses	
   Appendix B.  List of Exhibits	
   Appendix C.  Exhibits ...•	

   A discussion of each Individual section follows.
   Body of the Report

   Section I—Introduction.  The introduction will provide a  synopsis  of
   the investigation to orient the reader.  It should be brief.  A
   detailed discussion of the evidence will be provided in a  subsequent
   section of the report.

   Within the introduction, the following areas should be addressed:

        •  The identity of the corporate and Individual subject(s) of
           the investigation;

        •  A brief description of the nature and duration of  the
           criminal activity under investigation;

        •  Venue (i.e., the Federal district(s) in which the  offense
           occured).  If venue lies in more than one district, an
           explanation should be Included for the Region's choice  of
           one Federal district over another for referral; and

        •  The regional recommendation underlying the referral.

   Section II—Statutory Authority.  This section should include the
   statutory provisions that provide the basis for the referral.
   Pertinent portions of each statute should be quoted in full, followed
   by a listing of the elements of each offense that must be  provided  in
   a subsequent prosecution.

   Section III—Subjects of the Investigation.  This section  will  be
   used to provide pertinent background data on the subjects  of the
   referral.  For each individual subject, the following
   Information should be included:

        •  Name and title;

        •  Approximate age;

        •  Home and work addresses;

        •  Mature of current employment; and

        •  Criminal record, if known.
      Qmpliance/Enforceaent             9-17         Guidance Mamaa!  1983

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Chapter Nine	   	                              Exhibit  9-3
   For each corporate subject, Include:

        «  Name of company and parent corporation,  if  appropriate;

        •  Complete address of company;

        •  Complete address of facility associated  with offenses;

        •  State of incorporation of corporate  subjects;

        •  Registered agent for service; and

        •  A brief statement of the business, profits, and  size of  the
           company.

   Section IV—Enforcement and Regulatory History.   This section should
   include a description of all known enforcement activity  (State and
   Federal) relating to environmental matters taken against the subject
   in ate past. , In addition, any previous efforts  by  EPA to remedy .the
   present problem through Informal, administrative, or civil means
   should be discussed.*

   Finally, if the Region is recommending that  the  criminal referral be
   pursued simultaneously with a parallel civil/regulatory  proceeding
   against the subject(s), this fact should be  highlighted. The steps
   taken in the Region to ensure proper coordination and  separation of
   the parallel proceedings should also be described.

   Section V—Description of the Evidence.  This section will constitute
   the major portion of the report.  Its function is to present the
      ilts /of .^the Megaton** investigative activity and  to  demonstrate how
   the criminal -conduct •uncovered1 "in that Investigation •will be 'proved
   at trial.

   Background.  There is no one proper way to present  the evidence.  Any
   method that is clear and organized is acceptable.   A chronological
   approach is recommended, however, both because it is simple to follow
   and because prosecutors often present their evidence before the grand
  .Jury and at^trial within a chronological framework.

   Regardless of the organization chosen, all substantial facts detailed
   in this section should be supported by some item of evidence—a
   witness Interview, a letter from EPA correspondence files, an NPDES
   permit, results from a compliance Inspection, technical analysis of a
                    lakes :**M1^ ifrfT*"C Chi* xeport &o ovoid duplication.
     If facts relating to past regulatory or enforcement activity are
     discussed in subsequent sections (e.g., as evidence of a  "willfull"
     or "knowing" violation), only a brief  summary should  be included  In
     this section.
FXFRA Compliance/Enforcement              9-18          Guidance tirnmsT  1983

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Chapter Nine	Exhibit 9-3
   pollutant sample, a photograph, etc.   Copies  of  these  items  of
   evidence should be included, in turn,  as  exhibits  to  the litigation
   report, for easy reference by the reviewing personnel  at EPA
   Headquarters, the Justice Department and  the  United  States Attorneys
   Office.*  The existence of evidentiary support for the factual
   allegations contained in the referral  is  crucial.   The end goal of
   the referral process is a successful prosecution.   The question is
   not, ultimately, what happened but whether it can  be proved  at trial.

   Required Information.  In completing Section  V,  the  following items
   should be included (although not necessarily  in  separate portions of
   the section):

        •  A detailed review of all facts constituting  the alleged
           criminal behavior.  Speculation should be  avoided.  If the
           evidence currently available does not support  one or more
           elements of the offense(s) under  investigation, this should
           be highlighted, since this will assist in  focusing future
           investigation by grand Jury or otherwise;

        •  Any statements by the subject(s)  of the  investigation
           pertaining to the subject matter  of the  investigation.
           Written, as well as oral, statements  should  be included;

        •  Evidence indicating willful or knowing behavior by the
           investigative targets;
   * The following paragraph is an example  of  the  chronological
     presentation of evidence supported  by  exhibits:

          On May 1, an NPDES permit was  issued to  Company X
          that contained the following provisions...(see
          Exhibit 1, NPDES permit).  On  May 5, the plant's
          waste treatment system ceased  operation. (See
          Exhibit 2, Interview Report of Informant A.)   At that
          time, Company X faced several  imminent production
          deadlines.  (See Exhibit 3, Sales  Contract Between
          Company X and Company Y.)  Production continued,
          resulting in the discharge of  raw sewage between May
          5 and July 5.  (See Exhibit 4,  Analytical Reports
          Provided by Former Chemist of  Company X.)  Discharge
          monitoring reports submitted by Company  X for  this
          period nevertheless falsely reported compliance.
          (See Exhibit 5, Company X DMRs.)   Moreover, In
          response to an EPA Inquiry, Company  X reported the
          successful operation of its waste  treatment system on
          July 1, almost two months after the  breakdown.   (See
          Exhibit 6, Letter, Company X to EPA.)
FIFRA Qr*Bpi -t *nc*/Vnf*vrf«w«t-             9-19         Guidance Manual 1983

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Chapter Nine	                                            Exhibit 9-3
        •  Any  facts  that bear on the reliability of the available
           evidence.   This might include, for example, equipment
           breakdowns during technical sampling, or prior inconsistent
           statements of a government witness.  Ultimate conclusions
           should  not be made on the reliability of a particular witness
           or piece of evidence in the report; rather, simply include
           all  facts  relevant in assessing the reliability; and

        •  A complete chronology of contacts between EPA and the
           subject (s) concerning the environmental problem underlying
           the: referral.

   Section VI— Legal  Issues.  In preparing a case for trial, the Justice
   Department's prosecutor will want to consider both the weaknesses in
   the government's case and the affirmative defenses available to the
   defendants.   In completing this portion of the referral package,
   consider :
                 J)ef ""PCS.* -. Thin .night .Include , -,for example* .Arguments
           that .a. di scharge  of pollution WAS not Into a navigable water
           for the United States  and therefore not regulated under the
           Clean  Water  Act;  or that dumping activity did not Involve a
           "hazardous waste" identified  or listed under the Resource
           Conservation and  Recovery Act.

        •  Evidentiary  Challenges.   This might Include, for example,
           challenges to the methods used to obtain evidence, or to the
           government's ability  to  authenticate evidence due to a break
           in the chain of  custody.

        •  Equitable Defenses .   This might Include, for example, EPA's
          '^SffcV 3 1 fT ^ **"^?r^regu3 ytyy ' it*"mfn*f

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Chapter Nine    	    Exhibit 9-3
   Section VIII—Recommendation.   The  report  should conclude with a
   specific recommendation for  the appropriate future course of the
   case.  Normally, one of two  recommendations will be made:

        •  Further Investigation.   Where  the  use of an Investigative
           grand jury is  contemplated  (for  example when witnesses are
           not talking and compulsory  process is required), the referral
           will recommend further  investigation.  In this situation, an
           additional recommendation for  prosecution may or may not be
           appropriate.   If  the evidence  In hand provides an adequate
           basis on which to base  such a  judgment, a recommendation for
           prosecution under specific  statutory provisions should be
           included.  If  the available evidence is not sufficient, a
           prosecutorial  recommendation should be withheld pending
           completion of  the grand jury work  and consideration of the
           results.

        •  Prosecution.   If  the field  investigation Is complete, the
           conduct has been  documented, and grand jury work is
           required—if at all—only to present the evidence and secure
           an indictment, the referral should Include a recommendation
           for prosecution under specific statutory provisions.

   Following the specific recommendation, the report should include the
   best available projection of resources necessary to bring the case to
   resolution.  This projection should discuss investigative, technical,
   and legal resources and should  indicate  the Regional Office's
   ability to provide these  resources.

   Appendix A—List of Witnesses.   This section is particularly useful
   to prosecutors supervising the  case and  will frequently be used in
   issuing subpoenas, planning  a grand jury presentation, and estimating
   the scope of the prosecution.   For  each  witness, the writer should
   provide all available  background data  (e.g., name, residence, work
   address, telephone numbers,  etc.) and  a  brief summary (one paragraph)
   of the matters on which testimony is anticipated.  This section
   should include not only the  key substantive witnesses, but also those
   who will establish the appropriate  foundation for documentary or
   physical evidence (e.g.,  photographers,  chain of custody witnesses,
   record custodians, etc.).  Confidential  Informants should not be
   Identified In this list.

   Appendices B and C—List  of  Exhibits and Exhibits.  Copies of every
   substantial piece of documentary evidence  in the case should be
   Included as an exhibit to the report*  and  should be Indexed to allow
   * Exceptions will be made if the exhibit  is  too  bulky or otherwise
     inappropriate for inclusion in the  report.  Pollution samples,  for
     example, will remain with the regional  offices; however,  copies of
     reports reflecting their analysis should be included where possible.
FTFEA CoBpllance/Enforceaent             9-21         Guidance Ifennal  1983

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Chapter Nine	_Exhibit 9-3
   for easy reference in the main body of the report.   Original  exhibits
   or documents should not be included in the referral  package"if  this
   can be avoided.  They will normally be used as evidence  in trial, and
   should be retained in the Regional Office until other arrangements are
   made with the Justice Department prosecutor supervising  the case.
             ice/Kiiforceaeat             9-22         i>i^Bncg iton^i 1933

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Chapter  Ten
Post-Settlement Enforcement
Chapter Contents	Page
Monitoring Settlement Agreements                     10-1
Enforcement of Settlement Agreements                   10-1
FIFKA Compliance/Enxoroent          10-1

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Chapter Ten	                                            Contents
FIFBA Govpllance/Enforcaent              10-ii         Qildaiice Manual  1983

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Chapter Ten
Post-Settlement  Enforcement
Monitoring Settlement Agreements
The Agency often settles an administrative civil penalty action with a
violator prior  to the actual hearing*  thus obviating the need for  costly
litigation.  Such settlements under FIFRA take the form of consent
agreements and  consent orders.

Consent agreement negotiations focus primarily on the appropriate  size of
the penalty to  be imposed on the violator.  Adjustments to the penalty are
made by considering such factors as the  size of the business of the person
charged, the effect on the person's ability to continue in business, and
the gravity of  the violation.  However,  remedial performance as a  means of
remitting a civil penalty assessment is  generally not used in FIFRA consent
agreements and  consent orders.

In order to ensure continued compliance  with FIFKA as well as with the
terms of the consent agreement and order, the Agency performs
post-settlement monitoring, which includes:

     •  Follow-up inspections by EPA or  State personnel (depending upon
        whether the State has primacy  or a cooperative agreement,  or both)
        as a part of routine assignments under a neutral inspection scheme;
        and

     •  Ensuring that the violator has paid the stipulated civil penalty.
Enforcement  of  Settlement Agreements
Collecting fines that have been imposed under the terms of a consent
agreement and  consent order should be  followed up on a timely basis by
government personnel.  The procedures  and policies for collection action
referrals to the United States Attorneys Office are set forth in Appendix
4.
FIFKA comp-Liance/BOXorcBeat              10-1          Guidance aanuax 1903

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Chapter Ten
Post-Settl
,t Bnf or
Follow-up inspections  that reveal continuing violations of a  settlement
agreement could subject  the violator to additional  civil  penalty actions
or, in fact, subject the person(s) to possible criminal sanctions under
Section 14(b) of FIFRA.  (Consult Chapter Five for  the level  of action
guidance appropriate in  these situations.)
                                                                      •*'•
FIFKA umpi i «nre/aaro.
       Guidance

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Chapter Eleven
Special  Considerations
Chapter Contents	Page
FIFRA Section 7 Confidential Information                 11-1
Disclosure of Confidential Information                  11-3
     compliance/mrorce»enc          11-1       Guidance IMMMIMI 1983

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 Chapter Eleven	Contents
FIFMA Compliance/Bitorceaent              11-11          Guidance ••••••••••  1983

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Chapter  Eleven
Special  Considerations
FIFRA Section 7 Confidential Information*
Under TIFSA Section 7 jand Its implementing ^regulations , .persons who produce
pesticides or active ingredients  used in producing pesticides must register
their establishment with and submit  annual data to EPA.  Failure to do so
is a violation of Section 12(a)(2)(L).  Because some of the data submitted
in connection with Section 7 is confidential and may be used as part of an
active enforcement case, the following section on confidentiality and
disclosure of information is included in this manual.
Authority
.Section 7£d) of -FiFfiA states:  ."Any Information submitted to the
                                                             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 the provisions of section 10."

Section 10(b) of FIFRA states:  M...[T]he Administrator shall not make
public Information which in his judgment contains or relates to trade
secrets or commercial or financial information obtained from a person and
Section 12(a)(2)(D) of FIFRA makes  it unlawful for any person "to use for
his own advantage or to reveal, other than to the Administrator, or
officials or employees of the Environmental Protection Agency or other
   Confidential Information wobmitted pxirsTxant :4t» -Section 3 of 71FBA Is
   rarely used in case development work.  If the need to use Section 3 data
   arises, EPA's FIFRA Confidential Business Information Security Manual
   should be consulted.
FIFRA Compliance/Enforceaent        11—1               Guidance tfnrril 1983

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Chapter Eleven           	Confidential Tnforaatlon
Federal executive agencies, or to the courts, or  to physicians,  pharma-
cists, and other qualified persons, needing such  information  for the  per-
formance of their duties, in accordance with such directions  as  the
Administrator may prescribe, any information acquired by authority of this
Act which is confidential under this Act."
Penalties
FIFRA Section 10(f) states that any officer or employee  of  the United
States or former officer or employee of the United  States who willfully
discloses information subject to Section  10(b) is subject to  a $10,000
penalty, or Imprisonment for not more than one year, or  both.  Contractors
who are furnished confidential information as authorized by Section 10(e)
are considered employees and are subject  to these penalties.


Document Control

Chapter 12 of the EPA Securities Manual is applicable  to FIFRA privileged
information and should be referenced in matters pertaining  to document
control.  The chapter describes the policies, procedures, and responsi-
bilities regarding physical control of priviledged  Information received by
an officer or employee of EPA under a pledge of confidence  from a person,
firm, partnership, corporation, or association.


Section 7 Information

Procedures for Determining Confidentiality.  Under  EPA's Freedom of
Information Act (FOIA) regulations in 40  C.F.R. Part 2 Subpart B, a
procedure has been set up for determining whether Information is
confidential or nonconfidential.

Under this procedure, if information submitted to EPA  has been claimed as
confidential, the Information may not be  disclosed  to  the public until a
determination has been made that the Information is not  confidential, the
affected business has been given 30 days' notice of the  determination, and
the affected business has been given an opportunity to challenge the
determination.  Final FIFRA determinations are made by the  Office of
General Counsel..  However, program offices may make initial determinations
(see 40 C.F.R. §2.204).  If the program office makes the determination that
the Information may be entitled to confidential treatment,  the office must:

     •  Deny any FOIA request for the Information;

     •  Write to the affected business asking It to substantiate Its claim;
        and

     »  Refer the matter to the EPA legal office for a final
        confidentiality determination.
PIFitA tiOBpllance/anforceaent         Ttt               OnrlHiaiM*«» Mssraal 1983

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 Chapter Eleven	         Confidential Information
 If the program office  determines that the Information  In  question is
 clearly not entitled to  confidential treatment, the program office must
 give notice of the decision to the affected business and,  after the notice
 period ends, disclose  the  information to the requestor.

 Confidential Versus Nonconfldential Information*  Agency  determinations as
 to the confidential nature of Section 7 data are as follows:

      •  Confidential Information.  Information submitted  to the Agency by a
         producer operating an establishment and deemed confidential under
         Section 7 Includes .the amounts of a pesticide, or if applicable,
         active .ingredients used-in producing pesticides that:

         -  Are currently being produced,
         -  Were produced during the past year, and
         -  Were sold or  distributed during the past year.

      •  Nonconfidential  Information.  Information submitted to  the Agency
         by a producer  operating an establishment and deemed nonconfidential
         Bunder "Section  7  Jnr3u*1d00 or-active
         ingredients «sed In producing pesticides «old  or distributed at an
         establishment.   In addition, the following Section 7 Information is
         available on pesticide labels (which are available to the public)
         and, at the discretion of PTSCMS, is not considered confidential:

         -  The establishment name, number, and address, and
         -  For each pesticide or active ingredient used in producing
            pesticides, the product number 
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Chapter Eleven                                     Confidential  Information
      (Wliaace/Eaforceaeat	IF*	Goidanee Manual 1983

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Appendices
Chapter Contents	Page
1  Neutral Administrative  Inspection Scheme                  .A-l

   Producer Establishments                                   A-l
   Marketplace Inspections                                   A-3
   Restricted Use Pesticides                                  A-3
   Experimental Use Permit                                   A-4
   Books and Records Inspections                              A-4
2  Notices of Judgment                                        A-5

   Authority                                                 A-5
   Agency Policy          -                                   A-5
                          .                                   A-6
   Procedures                                                A-6
   Distribution                                              A-7
   Exhibit A-l:  Notice  of Judgment After Seizure              A-8
   Exhibit A-2:  Notice  of Judgment of Criminal
                 Proceeding                                   A-9
   Exhibit A-3:  Notice  of Judgment of Civil Penalty
                 Proceeding                                   A- 10
3  Sample Record Status and Permanent
   Abeyance Procedures                                        A-ll

   Sample Record Status                                       A-ll
   Permanent Abeyance  (PA) Procedures                         A-12
   Records Retirement and Retrieval                           A-12
F1FKA Pomp I 1 ance/BQ±orcp»Pnt             A-l          O»1|ilimpf Mm^i  1983

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Appendix	Contents
4  Collection of Civil Penalty Assessments                     A-13

   Authority                                                   A-13
   Policy                                                      A-13
   Collection Procedures                                       A-13
   Types and Methods of Payment                                A-15
   Suspension or Termination of Collection Activity            A-16
   Referrals Procedures                                        A-17
   Exhibit A-4:  Chapter 5-FCCS                                A-18
   Exhibit A-5:  Model Demand for Payment Letter               A-30
   Exhibit A-6:  Model Final Demand for Payment Letter         A-31
   Exhibit A-7:  Claims Collection Litigation Report           A-32
5  Expert Witnesses                                            A-69

   Selection of Witnesses                                      A-69
   Procedures for Requesting Witnesses                         A-70
   Appearing as a Witness                                      A-70
6  Penalty Policies                                            A-75

   Guidelines for Assessing Civil Penalties Under
      Section 14(a) and Citation Charges for Violations
       of FIFRA                                                A-77
   Guidelines for Enforcing the Child-Resistant
      Packaging Regulation                                     A-89
   Memorandum (22 Apr 1975)—Interim Deviation from
      Civil Penalty Assessment Schedule                        A-107
   Memorandum (11 Jun 1981)—FIFRA Enforcement Policy;
      Interim Penalty Guidelines                               A-109
7  Additional Sources of Compliance/Enforcement Information    A-121

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Appendix
1     Neutral  Administrative  Inspection
      Scheme
 The  following appendix outlines example criteria that may be applied by EPA
 Headquarters and Regional Offices (In cooperation with those States that
 have EPA Enforcement Grants) In selecting an activity for a programmed
 inspection.  Other acceptable criteria may be used in lieu of those
 examples listed below.  "For cause" or unprogrammed inspections, however,
are :not subject ;to neutral Inspection scheme requirements.  (See Glossary
 for  definitions of programmed and unprogrammed inspections.)

 All  programmed Inspections are conducted within the guidelines and
 priorities set forth in the Pesticides and Toxic Substances Enforcement
 Division's FIFRA Inspection Manual.
 Producer Establishments
frffdw**r-^»*"^M•fa*****m-:<»'*<* Inspected at least /once every two years.
DuBever, nbere violations of the •°ftet-jhave been observed during a programmed
inspection, a follow-up Inspection is to take place within six months  after
the programmed inspection.  These follow-up inspections continue at
six-month intervals until the violations have ceased.

Each Regional Office should have the following lists for each State under
its jurisdiction:
                     ;3jfc»t -of t3iose ^producer •stafaJdsfamegts :£ha£ Jiave jbeen
        Inspected during the past two years;

     •  Category II—a  list of those producer  establishments that  have not
        been Inspected  during the past two years; and

     •  Category III—a list of those producer establishments that have
                          .Hhere **?-0?-a:tliOlllg
 FIFRA Compllance/Kiforcement             A-l          Goidanre Manual  1983

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Appendix	Heutral Administrative Inspection
Each list contains both the name and EPA establishment  number of the
producer.  Producer establishments in Categories  I  and  II are arranged
according to the numerical sequence of  their  establishment numbers.
Selection of an establishment for inspection  is based upon the sequence
contained in the Category II list.

When a Category II establishment is inspected and found in compliance, it
is placed on the Category I list in numerical sequence  according to  its
establishment number.  However, a Category II establishment may be
scheduled for a follow-up inspection and placed on  the  Category III  list if
a programmed inspection uncovers a violation  of the Act.   Such a follow-up
inspection is to take place within six months after the programmed
inspection.  Follow-up Inspections may continue at  six-month intervals
until no further violations are found.  Once  found  in compliance with the
Act, the Category III establishment is placed on  the appropriate Category I
list.  Placement of an establishment on the Category I  list, however, does
not preclude the Agency from conducting a subsequent unprogrammed
inspection of that establishment under the provisions of  the warrants
section, FIFRA $9(b), when a violation of the Act is later suspected.

Ordinarily, the scheduling of Inspections Is  carried out  in accordance with
the numerical scheme of the Category II list. Nonetheless, in recognition
of the need to efficiently utilize Regional Office  resources, the following
adjustment factors may be employed to modify  the  selection:

     •  Location of the establishment.  For example, two  establishments
        located in the same geographic area may be  inspected at the  same
        time despite their numerical position in  the Category II list so
        long as one of the establishments has been  scheduled according to
        the numerical scheme;

     •  Seasonal nature of operations at the  establishment;

     •  Size of the establishment, number of  employees, and probable length
        of time required for Inspection.  For example,  if only two days are
        available to conduct a programmed inspection, then an inspection
        requiring more than two days should not be  scheduled at that time;
        and

     •  Specific^special circumstances.  For  example, inspection of  a plant
        that Is not operating normally because of a strike, should not be
        scheduled at that time.

Any Category II establishment that is not scheduled for inspection because
of the application of an adjustment factor retains  the  same priority on the
list that it would have had but for the adjustment.

The above adjustment factors are designed to  promote the  most efficient use
of compliance personnel and resources and may affect the  scheduling  of an
establishment inspection at any step in the selection process.
FIFBA Co«pliance/Baforce»ent             1^2\       grfdgrn*i» Mmmal

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 Appendix	Beutral Ad^*"-*Ptratlve Inspection
 Marketplace Inspections	'


 It is  the Agency's Intention to conduct a regular inspection at each
 marketplace establishment at least once every four years.  However, where
 violations of the Act have been found during a programmed inspection, a
 follow-up inspection is to take place within six months of the programmed
 inspection.  Follow-up Inspections continue at six-month intervals until
 the violations have ceased.

 Each Regional Office should have the following lists for each State under
 its jurisdiction:

     •  Category I—a list of those marketplace establishments that have
         been Inspected during the past four years; and

     •  Category II—a list of those marketplace establishments that have
         boon Inspected .during ^ the past-four years and where violations of
         the Act 
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Appendix	   Heutral M*r* "*««•*•*«• *™» Inspection
Experimental  Use Permit
The Regional Office is  responsible,  on a selected basis, for supervision of
the experimental uses conducted  within its Region.  Supervision is for the
purposes of observing and  reporting  whether the terms and conditions of the
permit are being met and to determine whether the terms and conditions are
adequate to avoid unreasonable adverse effects on the environment.

Each Regional Office should establish its own supervision schedule based on
the following list of priorities:

     •  Permits for pesticides that  are completely new classes of
        compounds (e.g., j uvenlle  hormones);

     •  Permits for chemicals with special potential hazard to man or the
        environment, such as:

        -  Highly toxic products,
        -  Products with a propensity to drift,
        -  Products with high terrestrial or  aquatic mobility, and
        -  Products of  a particularly persistent nature;

     •  Permits for chemicals with previously registered uses that were
        subject to adverse action  on the Agency's part;

     •  Permits for those companies  that have a history of noncompliance,
        inadequate supervision, or other indications of an uncooperative
        attitude;

     •  Permits for those chemicals  that may  ultimately have a widespread
        major use (e.g., chemicals that will  replace a major pesticide
        that has been cancelled by the Agency); and

     •  Any other permits for which  the Registration Division requests
        special information.
Books and Records Inspections


As a practical matter, the books and records  inspection program should be
an integral part of the establishment Inspection program.  Books and
records should be examined whenever a producer  establishment Inspection is
made; but, such an examination should not be  limited  to only those
Inspections.  For instance, books and records inspections may be made upon
a specific request for certain information, or  as  a follow-up to an Agency
stop sale, use, or removal order.
      UDspxiasce/aoxorceaent             A—4            1^114*1*1*1* tvnnrf*  1983

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Appendix
2     Notices of Judgment
Authority
Under .Section 16.C4) of F/IEHA, xtie Adainlstrator of EPA ±a jrequired to give
notice by -publication of all judgments entered to actions Instituted under
the Act.  The purpose of this publication is to make available to the
public the results of court decisions and civil penalty  proceedings
involving pesticide! products and devices.  A notice of  Judgment contains
the following information:

     •  Responsible party;

     •  Specific violations;

     •  Dates and nature of the legal action; and

                                    f* "T* r
Agency Policy
The Agency publishes a notice of judgment for each seizure, criminal
                                                »  •*
         sbe;>publlsbed ±n -,-vthe ^following Instances :
     •  Seizures .  When no  product is available for  seizure;

     •  Criminal Cases.  When cases are declined for prosecution by the
        U.S. Attorney;  and
    -m. : CLvll Qj«T)1alTrr«.  ««n dvll £9^tlalut« «re Kttbdranm i>y the
        Agency teTore the respondent files an answer.
In civil penalty cases Involving a hearing before an Administrative Law
Judge, the entire initial  decision will be published In the notice of
Judgment.
FIFBA ampliance/Biforcement          A-5             Qn44m~f Manual 1983

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Appendix	  	   	notices of Judgment
Responsibility
The Assistant Administrator for Pesticides and Toxic  Substances  has  been
delegated, by the Administrator, the authority to give notice  by
publication of all judgments entered in actions instituted.  Within  the
Office of Pesticides and Toxic Substances, PTSCMS is  responsible for
preparing the notices of judgment.
Procedures
Regional Office

Each EPA Region will maintain a record of all seizure  and  criminal  referral
actions and all civil penalty complaints Issued.  Each case will  be
reviewed after its conclusion to determine whether all necessary
information is present in the file.  Once an action has been  completed,  the
Region will prepare a draft notice of judgment and forward it to  the
Headquarters Case Development Officer (HQCDO).  To ensure  completeness and
uniformity of reporting, information for notices of judgment  should be
submitted in the format shown in Exhibits A-l, A-2, and A-3,  as
appropriate.

The draft notices must be complete, accurate, and legible  to  avoid  any
misinterpretation of spelling, citations, etc.  The proper and complete
name of the firm and product Involved must be used.  Because  of the wide
distribution of notices of Judgment, including some to the respondents and
defendants, it is Important that the information reported  for Inclusion  in
the publications be factual.

The statutory references and charges to be Included for publication in a
notice of judgment include all the charges made in the indictment or civil
complaint.  If any of those charges are dismissed, withdrawn, or  dropped,
the information should be included in the concluding paragraph of the
notice that summarizes the final results of the action.  The  Regions will
promptly inform the appropriate HQCDO of the termination of each  seizure,
criminal action, and civil proceeding.  It is important that  information be
furnished on each case to which an I.F.&R. Docket Number has  been
assigned.  If the case is withdrawn before the answer  is filed, a negative
report should be submitted to account for all I.F.&R.  Docket  Numbers.


PTSCMS

The HQCDO will review the draft notices of judgment submitted by  the
Regions for completeness and accuracy.  Notices of judgment will  be printed
at reasonable Intervals, in groups of 50 or more.
FUfMA Uoapliance/Eoforceaent            A-6   °         Goldi

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Appendix	         	               Botlces of Jud
Distribution	


Distribution of notices of judgment will be made by PTSCMS, who regularly
compile a mailing list of recipients of the notices.   Such recipients
include libraries, universities, civic groups, pesticide producers, and
private citizens.  Other distribution may be made by special request.
      uoapJOance/Enxorceaent            A-/            Guidance

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Appendix	Exhibit A-l


                      Notice of Judgment After  Seizure
   United States of America v.  40 one-gallon jugs
                                       (Amount)

   more or less, of a product labeled  in part     HELENA BEAM) PRO-LIN

    WEED
   U.S. District Court, District of New Mexico.    November  29,  1972
                          (Judicial District)     (Date  of  Final  Decree )

   (I.F.&R. No.   VI-17 _ I.D. No(s).    90829 _ .)

   This was a seizure action charging the product with  being in  violation
   of the Federal Insecticide, Fungicide, and Bodenticide  Act, 7 U.S.C.

   i!36k(b) _  _ _ _
                          (Statutory References)

   The action pertained to (complete a. or b.)
   a.  A shipment (s) made

        on      May 2, 1972 _ ,

        by _ Helena Chemical Company _ ,

        from    Lubbock, Texas                                           ,

        to      Dexter, New Mexico _ ,

   b.  A product (s) held for distribution or sale

        on                                                               ,
                             (Date of Inspection)

        at _ ; _ ,
             -«-        (Name of Producer Establishment)
                               (City and State)

        Charges included nonregistration.

        (Type of Final Decree and Disposition of Product)

        The Judgment Decree of Condemnation ordered destruction  of  the
        product.
FIFRA Coapliance/Biforceaent             A-8          Guidance Manual  1983

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Appendix	Exhibit A-2


                  Notice of Judgment of  Criminal Proceeding



   United States v.    Sterling Drug,  Inc.     	,
                            (Name of Defendant)

   U.S. District Court,   Northern District of Ohio                      ,
                                  (Judicial District)

   Criminal No.  CR 73-135     ,  July  26,  1974	.
                                       (Date of  Final Decision)

   (I.F.&R. No.   1363	,  I.D. No(s). 72760.  73184,  73706,  & 78835.)

   This was a criminal action prepared by EPA Region  V      charging the
   defendant in a(n)  five   	count information  (indictment)
   with violating the Federal Insecticide,  Fungicide, and  Bodenticide Act,
   7 U.S.C. 8§136j(a)(l)(B); 136j(a)(l)(E); 136(q)(l)(A);  and 136(q)(l)(G)
                           (Statutory References)

   The action pertained to  (complete a. or b.)
   a.  A shlpment(s) made

       on   October 2 and  25, 1968; December  16,  1968;  and  July 21,  1969,

       from    Toledo, Ohio _ •                   _ ,

       to  Buffalo, New York; Pocatello,  Idaho; Omaha,  Nebraska;  and    ,
   b.  A product (s) held for distribution or  sale

       on
                             (Date of Inspection)

       at
                         ___
                         (Name of Producer Establishment;
                               (City and State)

   The pestlcide(s) involved was (were) ROCALL BRAND SANITIZING AGENT and
   BARRAGE CONCENTRATED BOWL CLEANSER; charges Include:   claims differed
   from those made in connection with registration,  and mlsbranding—
           .MBS- JQO£ f ^ffrtlTf "fapn ncnd ac ^dJxecfiAdf^and • li«* k of aiifiiiur-r


   The defendant entered plea of nolo contendere  to counts 1 and  2.
   (Give plea and list all counts.) The remaining counts  were  dismissed.

   A fine of $  500.00    was levied.
                                         Ar*9           (^f ^"TICI*  M>n"*l  1983

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Appendix
                                                 Exhibit A-3
               Botlce of Judgment of  dvll Penalty Proceeding
   In Be:
Steelcote Manufacturing Company
   EPA Region  VII
               (Name of Respondent)

            September 3. 1974	
   (I.F.&R. No.   VII-A6C
                     (Date of Final Order)

                 , I.D. No(s).   91563
   This was a civil action charging the respondent  with violating the
   Federal Insecticide, Fungicide, and Rodenticide  Act, 7 U.S.C.  	
                                                             ;  and
   136(q)(2)(C)(iv)
                           (Statutory References)

   The action pertained to  (complete a. or  b.)
   a.  A shipment(s) made
       on
       from

       to
   b.  A product(s) held for distribution or  sale

       on   September 7, 1973	
                               (Date of  Inspection)

       at   Steelcote Manufacturing Compan;
                        (Name or Producer Establishment)

            St. Louis, Missouri                                          »
                                (City and State)

  The pesticlde(s) involved was(were) DAMP-TEX A & A  SEALER;

  charges include:  lack of adequate warning or caution statement on
  labels, lack of adequate directions for use on labels, lack of  assigned
  registration number on labels, and labels bore false or misleading
  safety claims.

  (Complete summary of final results Including hearing, default,  acceler-
  ated decision, consent agreement, final order, and  amount of  assessment.
  If withdrawn after answer, explain.)

  The respondent signed a consent agreement.  The final order assessed  a
  civil penalty of $1,200.
FIFRA Oaapll ance/Enforeement
                            A-10
1983

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Appendix
3    Sample  Record  Status and  Permanent
      Abeyance  Procedures
 The purpose of  this section is to set  forth guidelines for placing sample
 records in different categories of activity.  It also gives guidance on
 retiring inactive records.
 Sample Record Status
 For record management purposes, sample  record cases are placed in the
 following categories:

     •  Active .  A sample record file is considered active throughout the
        testing and review period until it is officially determined in
        writing that no enforcement action is Indicated or until all
        enforcement actions and correspondence have been concluded.

                  After It feaa teen 'ggtcTaiacd that «no enforcement -action
        is indicated or after all enforcement actions and correspondence
        have been concluded, but the file needs to be retained for
        reference, the sample record is considered to be in abeyance
        status.

        Permanent Abeyance (PA).  When correspondence is no longer being
        carried on with the firm, no further action is expected or
        ,iHT>f'ffl>> ;fnfl -tlir "o** :i*ff 'Clof^id j ''^*i* "nitf "** TlTT^d "*"** TTBrrmanrnT
        abeyance .  "In the instance of notice of warning letters , if no
        reply from the firm is received within 90 days, the sample record
        should be removed from active status and permanent abeyance
        procedures Initiated.
 FIFKA Coapliance/Eoforceaent          A-11          Guidance M^»mvf1  1983

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Appendix	Sample Record Status and Permanent Abeyance Procedures
Permanent Abeyance  (PA)  Procedures	


Types of PA

PA Without Action.   Refers  to  placing a sample record in permanent abeyance
because the sample  is  chemically and biologically satisfactory and meets
all the labeling  requirements  of the Act.

PA With Action.   Refers  to  placing  a sample record in permanent abeyance
after the enforcement  action has been concluded.
PA Procedure

PA Without Action.   If examination  of  the sample record reveals that no
enforcement action is warranted:

     •  Mark  "PA" and the date on the  face of the sample record jacket; and

     •  On a  monthly basis,  the Regional Offices will notify the
        appropriate  laboratories of the sample(s) that vas(were) placed
        into  permanent abeyance.  THIS IS IMPORTANT—It notifies the
        respective laboratories that the file has been closed and that the
        sample can be disposed of in accordance with the appropriate
        disposal method.

PA With Action.  When it is  determined that no further action is necessary
after an enforcement action  and subsequent follow-up, then follow the above
steps under "PA Without Action."
Records Retirement and Retrieval
The EPA records disposition program is designed to provide for the regular
removal from valuable office space of all  records  and nonrecord materials
no longer essential for current operations, and for the systematic release
of filing equipment for reuse.  At regular Intervals PA sample records
should be transferred to the appropriate Federal records center.
      u>mp.u.ance/Enforcement           A-12             Guidance ***"**>•  1983

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 Appendix
4     Collection  of  Civil  Penalty
       Assessments
 Authority
 Upon nonpayment of a civil penalty within the prescribed time  periods,
 Section 14(a) (5) of the Act «pecifies that the aatter be referred to the
 Attorney General for collection:  "In case of inability to collect such
 civil penalty or failure of any person  to pay all, or such portion of such
 civil penalty as the Administrator may  determine, the Administrator shall
 refer the matter to the Attorney General, who shall recover such amount by
 action in the appropriate United States district court."

 However, before any referral to the Attorney General, the Agency must
 satisfy the  directives and standards for collection set forth  in the
 Federal Claims Collection Act (31 U.S.C. $5951-953) and the Federal Claims
 Collection Standards (FCCS, 4 C.F.R. IS101-105 Exhibit A-4).
    'general, the procedures jln the FCCS are Mndatory, but the failure of
     Agency to -comply -with -any provision of 'the standards -will not be
 available as a defense to any party in a subsequent action  for collection.
 Policy
          1CCS, • +***'. .*||p»»-y --*«-»ai«il a -•*•«
 collection action, on a timely basis, and with effective follow-up of all
 civil penalty assessments.
 Collection Procedures
 Written Demands  for Payment

 The FCCS requires that the Agency make three written demands, at 30-day
 intervals,  on  the respondent in terms that Inform the debtor of the
 consequences of  failing to cooperate.
       compliance/Bnxorceaent            A-13          Guidance •«•*««•' 1983

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Appendix	    Collection of Civil Penalty Assessments
The Agency's policy  is  to  initiate  the written demands concurrent with the
issuance of a final  order  so  that the  third and final demand will be made
on the same day the  payment period  elapses  (i.e., 60 days after Issuance of
a final order).

Upon the Issuance of the Final  Order.   At the time that a final order is
issued and served on the respondent, he or  she should receive a written
demand for any payment  of  such  penalty and  the length of time in which he
or she has to pay it.  Such notice  should also inform the respondent of the
consequences of falling to cooperate.

Thirty Days After Issuance of the Final Order.  After 30 days have elapsed,
even though the payment period  has  not expired, the Agency will again serve
on the respondent a  demand for  the  payment  and again warn the respondent of
the consequences of  failing to  pay  (Exhibit A-5).  Given the possibility
that the payment may be in the  mail when this second warning is sent, the
Agency should also make a  brief apologetic  statement informing respondent
to disregard the warning if the payment has been sent.

Sixty Days After the Issuance of the Final  Order.  The respondent must pay
the civil penalty 60 days  after the service of a final order unless a
motion to reconsider has been made  or  judicial review of the final order
has been sought.  Subject  to  those  two exceptions, if payment of the
penalty has not been tendered at the end of the 60-day period, the Agency
will send a final demand to the respondent  for payment of the delinquent
civil penalty assessment.  This letter should be written to inform the
respondent that unless  payment  is tendered  within 15 days, the penalty will
be referred to the United  States Department of Justice or the United States
Attorneys Office for collection in  a district court.  The letter should
state that such action  is  routinely accomplished through a motion for
summary judgment in  favor  of  the United States and that the respondent will
be barred from raising  any issues as to fact or law that should have been
raised in the administrative  proceeding (Exhibit A-6).


Follow-up to Final Demand  for Payment

Section 102.6 of the FCCS  dictates  that the Agency undertake personal
interviews with the  debtors when it is feasible, having regard for the
amounts Involved and the proximity  of  Agency representatives to such
debtors.

It is PTSGHS policy  to  arrange  personal interviews if it is feasible and
convenient for the regional officials  involved in the case.  In the absence
of a personal interview, the  Regional  Office should at least establish
telephone contact with  the respondent  to urge prompt payment of the claim
and to personally warn  the respondent  of the consequences of falling to pay
the penalty.

Good faith inability to arrange a personal  interview or to establish
telephone contact with  the respondent  should not deter the Regional Office
from referring claims to the  United States  Attorneys Office for collection.
      UMp.uance/mxorcement             A—14           Guidance nr******  1983

-------
Appendix	Collection of Civil Penalty Assessments
Documentation  of  Collection Efforts

The Agency should record and maintain a file of all collection efforts and
activities prior  to referral.
Types and  Methods  of Payment
Full Payment

The most  preferable method of collection is a check for the full amount
owed, payable  to  the United States of America.  Such payment should be
delivered to the  Regional Hearing Clerk for the Region In which the final
order was issued.
            jTtat'al Itnonf-o
Section  102.10  of  the FCCS provides for Installment payments.  This type of
payment  should  be  used when the respondent has demonstrated and documented
an inability  to pay  the penalty in a lump sum.

In that  Section 14(a)(4) of FIPRA requires a consideration of ability to
continue in business in assessing the penalty* this installment provision
should rarely be needed as the  issue will have been previously resolved.

In the event  that  installment payments are Justified and allowed, such
payments shall:

     •  Be an a Tegular basis;

     •   Bear  a  reasonable relation to the size of the debt and the debtor's
        ability to pay;

     •   Be sufficient in size and frequency to liquidate the claim in not
        more  than  three years;  and

     •• >-Bfi-jio ,jpnn -than S10 except under--tine••ost .jmusual f*1 TV*iMa^fTfi*??,

In allowing a respondent to pay by installment, the regional attorney
should attempt  to  obtain an executed confess-judgment note, comparable to
the Department  of  Justice Form  USA-70a.

The Agency may  accept installment payments notwithstanding the refusal of
the respondent  to  execute a confess-Judgment note.


Compromise of the  Penalty

The FCCS provide for compromising claims  when it can be assured that the
respondent's  financial ability  will not permit payment of the claim In full
FIFBA Coapllance/anrorcement             A-15          Qn-idimce Manual 1983

-------
Appendix     	             Collection of Civil Penalty Assessments
or when  the  litigatlve  risks  or  the  costs  of  litigation dictate such
action.

It is the express policy of PTSCMS that  penalty assessments in final orders
shall not be subject  to compromise except  under the most unusual
circumstances.  For the most  part, FIFRA requires  that ability to pay be
considered before a civil penalty is imposed;  therefore, the inability to
pay the  penalty should  not be an issue in  the post-final order stage of the
civil penalty proceeding.  However,  inability to pay should be considered
where:

     •   The  civil penalty was assessed by  default, so that the respondent's
         ability to pay  was never confirmed by the  respondent in determining
         the  amount of the penalty; or

     •   The  respondent's financial condition  has deteriorated dramatically
         since the time  the penalty was assessed.  The Agency should be
         alert to the  possibility that assets  have  been fraudulently
         concealed or  Improperly  transferred.   The  burden falls upon the
         respondent to affirmatively  demonstrate and document any such
         inability.

Section  103.5 of the FCCS provides that, where an  enforcement policy is
concerned, a penalty should only be  compromised if the sum to be agreed
upon will adequately  serve the Agency's  enforcement policy in terms of
deterrence and securing compliance.

For this reason, and for the  reason  that a respondent usually has already
had an opportunity for  settlement, the compromise  provision should be
rarely exercised.

In the event such a compromise is effected, it must be authorized by the
Regional Administrator  for it has the effect  of altering the final order.
Suspension or Termination of Collection Activity	


Suspension   _,^

The Agency may temporarily suspend collection action  for payment of a
penalty when the respondent cannot be located after a diligent search
and/or when future collection prospects seem more promising than present
actions.

Section 104.2 of the FCCS provides a partial listing  of  sources that may be
helpful in locating missing respondents.  Efforts should be made to avoid
any applicable statute of limitations.
FIFSA Compliance/Enforcement             A-16          Gaidar*"* MMMI  1933

-------
Appendix         	    	  Collection of Civil Penalty Assessments
Collection  action may be  terminated  and the Agency's file on the penalty
closed under  the following conditions:

     •   Inability to  collect  any substantial amount;

     •   Inability to  locate debtor;

     •   Cost  will exceed  recovery;

     •   Claim legally is  without merit; or

    . •   Claim cannot  be substantiated by evidence.

Section  104.3 of the  FCCS provides further information on termination of
claims.



Referrals Procedures                                                       ~


General

Claims on which aggressive collection action has been taken and that cannot
be compromised will be referred  to the  Department of Justice or the United
States Attorneys Office.   Such referrals should be made as early as
possible consistent with  the  aggressive Agency collection action and the
standards for collection  set  forth in the FCCS.
         "Parties  and minimum Amounts
Department of Justice.   All penalty assessments  in the amount of $10,000 or
greater should  be  referred  to  the Department  of  Justice.

United States Attorneys  Office.  All penalty  claims in amounts less than
$10,000 should  be  referred  to  the appropriate United States Attorneys
Office.      ^

When referring  a claim of less than $600 for  collection ,  the Regional
Office must emphasize to the U.S. Attorney  that  the referral is Important
to a significant enforcement policy.


Procedures for  a Proper  Referral
             wcUMtamy > should prepare the -dains t3oll«ction litigation
Report (CCLR) for  the U.S.  Attorney consistent with the  form and
instructions in  Exhibit A-7.
                                         A-17           tinijtm^ff  Manual  1983

-------
Appendix	fcrMblt A-4
       CHAPTER  II—FEDERAL CLAIMS  COLLECTION

          STANDARDS (GENERAL ACCOUNTING
            OFFICE—DEPARTMENT OF  JUSTICE)
       Part                                                Foot
       101    Scope of standards	.——~...~.	    90
       102    Standards for the  administrative collection of
               Claims, ,........,,„..,.,...,.....,...„,,.„„,„,., ........................1^.    91
       103    Standards for the compromise of claims,....	....  .  95
       104    Standards for suspending or terminating collec-
               tion action ...~......~...~...~......~..~....~~..~....................    97
       105    Referrals to GAO or for litigation Mk.MM.M.MM..MM	    98
FXFRA On^pHaiM'O/Hnf"^*«*aent            A-18         ^Unn**** Manual 1983

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Appendix
                                   Exhibit A-4
        9107.1

          PART 101—SCOPE OP STANDARDS

        Sec.
        10L1  Prescription of standards
        10U  Omissions not * defense.
                                 tax 'dabns ex-
        101.4  Compromise,  waiver,  or disposition
           under otner statutes not precluded.
        10LA  Conversion claims.
        1014  Subdivision of claims not authorised.
        101.7  Required administrative proceedings.
        101J  Referral for litigation.
          Atmioamr: See. a. 80 Stat. 309; 31 U.S.C.
        982.
          Sorace 31 TO 13381. Oct. IS. 1966. unless
        Otherwise noted,

        f 10U Awcriptia« «f Ataariavda,
          The regulations  in  this   chapter.
        issued jointly by the Comptroller Gen-
        oral of the United States and the At-
        torney General of the United States
        under section 3 of the Federal Claims
        Collection Act of 1986. 80 Stat 309.
        prescribe  standards for the  adminis-
        trative collection, compromise, termi-
        nation of agency collection,  and the
        referral to  the  General  Accounting
       ' Office, and to the Department of Jus-
        tice for litigation, of civil claims by the
        Federal Government  for money  or
        property.  Additional guidance is con-
        tainmt hi  Xttte «* «f the <3enerml Ae-
       .. f.».|fffluy ywfi^» .affr.*^! yfrf-frUidtTtrr
        of Federal Agencies. Regulations pre-
        scribed by the head of an agency pur-
        suant to  section 3  of the  Federal
        Claims Collection Act of 1966 will be
        reviewed  by the General  Accounting
        Office as a part  of its audit of the
        agency's activities.
        C44 PR 22701. Apr. 17.1979]
        • 10L1
                                        hA««v^ V
        ter shall  apply to the administrative
        hunting of dvQ *Ja.<»«« of the Federal
        Government for money or property
        but the failure of an agency to comply
        with  any  provision  of this chapter
        shall not be available as a defense to
        any debtor.

        1 191.3 Fraud. >p*«*»"f«  ,and lax. .daiau

          The standards set forth hi this chap-
        ter do not apply  to the handling of
        any claim as to which there is an indi-
                    TM*
 cation of fraud, the presentation of a
 false claim, or misrepresentation on
 the part of the debtor or any other
 party having an interest in the claim.
 or to any claim  based in whole or in
.part on conduct in  violation of  the
 antitrust laws. Only the Department
 of Justice  has  authority to compro-
 mise-or terminate collection action on
 such claims. However, matters submit-
 ted to the  Department of Justice for
 consideration without compliance with
 the regulations in £*»
-------
Appendix
                                                                         Exhibit A-4
        Chapter
                   doinrs Coltoctfon Standards
        • 101.5  Conversion daiiM.
          The  instructions contained  in  this
        chapter are directed  primarily to the
        recovery of money on behalf of the
        Government and the circumstances in
        which  Government *>»<»»« may be dis-
        posed of for less than the full amount
        claimed. Nothing contained in  this
        chapter is intended, however, to deter
        an agency from ^•""•r* **fpg the return
        of specific property or from demand-
        tag.  in  the  alternative, either  the
        return of property or the payment of
        its value.

        1101.6  Sabdhrbion of claims act author.
           isad.
          A  debtor's liability arising from a
        particular  transaction   or  contract
        shall be considered as a single claim in
        determining whether the claim is one
        of less than (20.000. exclusive of Inter-
        est, for the purpose of compromise or
        termination of collection action. Such
        a claim may not be subdivided to avoid
        the  monetary ceiling established by
        the Federal Claims Collection Act  of
        1966. 80 Stat. 308.
                        administrative proceed-
• 101.7  Required
   tags-    .
  Nothing contained in this chapter is
intended to require an agency to omit
or foreclose  administrative proceed-
ings required by contract or by law.

1101.8  Referral for litigation.

  As used in  this chapter referral for
litigation  means  referral to the De-
partment  of Justice for appropriate
legal  proceedings, unless the  agency
concerned has statutory authority for
          3 own litigation,
        FAIT  102— STANDARDS  FOR  THE
          ADMINISTRATIVE COLLECTION  OF
          CLAIMS
        See.
        102.1  Aorwiive agency collection action.
        10X2  Demand for payment.
        1014  Collection by offset
        102.4  Reporting delinquent debts to com-
           mercial credit bureaus.
        102J  Contracting for collection services.
        102.6  Personal Interview with debtor.
        102.7  Contact  with debtor's  employing
           acency.
                                       1023 Suspension or revocation of license
                                          or eligibility.
                                       1024 T|itpiffitn«m of collateral.
                                       102.10 Collection in 1nTt*"Ti*"f"
                                       102.11 Exploration of compromise.
                                       102,12 Interest.
                                       102.13 Analysis of coats.
                                       102.14 Documentation  of administrative
                                          coIleeUon action.
                                       102.1ft ft**t"nflTf'fn
                                       102.16 Prevention of overpayments, deltav-
                                          «]^pffyf ft*"* ittflllltt
                                       10247 Additional admtniatraUv* coUecUon
                                               TT: Sec. 3. 80 Stat. SO*: 31 VAC.


                                                                   collection
  The head of an agency or his desig-
nee shall take aggressive action, on a
timely basis with effective followup, to
collect all claims of the United States
for money or property arising out of
the activities of. or referred to.  his
agency  in accordance with the stand-
ards set forth in this chapter. Howev-
er, nothing contained hi this  chapter
is intended to require the General  Ac-
counting Office or the Department of
Justice  to duplicate collection actions
previously undertaken by  any other
agency.
[31 PR 13381. Oct. 18.1066]

• 1025 Demand for payment.
  Appropriate written demands  shall
be made upon a debtor of the United
States  in  terms which inform  the
debtor of the consequences of his fail-
ure to cooperate. In the  initial notifi-
cation, the debtor should be informed
of the bagia for the 
-------
Appendix
                                                            Exhibit A-4
        §10X3

        i* necessary to protect the Govern-
        ment's interests (e.g.. the statute  of
        limitations (28 UJS.C.-2415)). Agencies
        should respond promptly to communi-
        cations from  the  debtor. Agencies
        should advise debtors who.diapute the
        debt to furnish available evidence  to
        support thftlr con t^n M^TT"

        144 FB 33702. Apr. IT. OTM

        B102J  Collection by ofbct
          (a) Collections by  offset will be un-
        dertaken  administratively in  accord-
        ance with these standards and imple-
        menting regulations established by the
        every instance in which this Is feasi-
        ble Collections by offset from persons
        receiving pay or compensation from
        the Federal Government shall be ef-
        fected over a period not greater than
        the period during which such pay or
        compensation h) to  be received. See 5
        U.S.C 5514.
          (b) When the head of an agency, or
        his designee.  pursuant  to 5  U.S.C.
        5514. 5522. 5705. 5724(f). or other stat-
        utory authority, seeks to collect a debt
        by offset against accrued pay. compen-
        sation, accrued benefits  derived from
        federal sendee or  tmmtnt ot
        "Government employee, a member of
        the armed  forces,  a Reserve of the
        armed forces, or a present or former
        employee of the U-S. Postal Service.
        the agency to which the debt allegedly
        is owed will accord such debtor an op-
        portunity for a pre-offset oral hearing
        when:
          (1)  The  debtor  requests waiver of
        the Indebtedness and the waiver deter-
             ^MmSttf^e-nt" when "the tedlvld-
        ual requests reconsideration  of the
        debt and the head of the agency or his
        designee determines that the question
        of the indebtedness cannot be resolved
        by review of the  documentary evi-
        dence, for example, when the validity
        of the debt turns on an Issue of credi-
        bility or veracity: Provided that, where
        paragraph  of this sec-
        tion  terminates,  and  the  creditor
        agency determines that:
                            (1). Amounts, accruing to the debtor
                          upon such  termination  are  available
                          for offset in satisfaction of the alleged
                          indebtedness, (ii) such amounts would
                          not be available for offset subsequent
                          .to termination and (ill) the time prior
                          to termination does not permit a ore-
                          offset hearing, the agency may with-
                          hold from amounts nffcr"lT*g to the in-
                          dividual upon termination, a sum not
                          greater than that of  the alleged in-
                          debtedness  and, subsequent to termi-
                          nation,  promptly provide an opportu-
                          nity for an oral hearing to resolve the
                          issue   of  indebtedness   or  waiver.
                          Amounts  withheld  but   later deter-
                         • shall be^promptly refunded.
                            (c) Except for debt collection sys-
                          tems in which determinations of in-
                          debtedness  or waiver rarely involve
                          Issues  of credibility or veracity, or
                          when employment or military status is
                          about to terminate as described in the
                          proviso of paragraph (b) of this sec-
                          tion, prior to collecting any indebted-
                          ness by offset the head of the agency
                          to which the debt allegedly is owed or
                          his designee shall provide the debtor a
                          written demand containing the notices
                          prescribed hi 1102.2 of this part and
                          include therein:
                          •"T Appropriate use should be made
                          of the cooperative  efforts of  other
                          agencies la  effecting collections by
                          offset.  Including  utilisation  of the
                          Army Holdup Ust. and all agencies are
                          enjoined to cooperate in this endeavor.

                          [46VRW113.July31.1981]
                            Agencies shall develop and  imple-
                          ment procedures for reporting delin-
                          quent debts to commercial credit bu-
                                           92
FIFBA Oompl±i
>/Enfor
A-21
Guidance
1983

-------
Appendix
                                  Exhibit A-4
         Chapter II—Federal Gaiim Collation Standards
                             §102.8
         reaus. In the  absence of a different
         rule prescribed by statute, contract, or
         regulation, a debt is considered delin-
         quent if not paid by the date due spec-
         ified hi the  provide the credit
         bureaus  with  corrections  and nota-
         tions of disagreement by the  debtor;
         and  (d) make reasonable  efforts to
         assure that the information to be re-
         ported is accurate,  complete,  timely.
         and  relevant. Prior to exercising the
         option of reporting delinquent debts
         to commercial credit bureaus, agencies
         should send a  demand letter advising
         the  debtor that such reporting  will
         take place within a specified period of
         time unless the debtor makes satisfac-
         tory payment arrangements or  demon-
         strates some basis on which the debt is
         legitimately disputed.
         (44 FR 32702. Apr. 17.1979]  "

         • 10tS Contracting for collection  atrvleca.
          Agencies should consider contracting
         for collection services. Contracts may
         be entered into for this purpose when
         they meet the following conditions:
          (a) The  service  must  supplement.
         but  not replace, the  basic collection
         program of the agency: (b) the  author-
         ity to resolve disputes,  compromise
         claims,  terminate  collection  action.
         and  initiate legal action  must be  re-
         tained by the agency and; (c) the con-
         tractor shall be subject to the  Privacy
         Act of 1974. as amended. 5 U AC 552*.
         and. when applicable, to  Federal and
         State laws and regulations pertaining
         to debt collection practices such as the
         Fair Debt Collection Practices  Act. 15
         UJ3.C. 1692.
         (46 FR 22393. Apr. 20.10811

         B 102.6 Personal interview with debtor.
          Agencies will undertake personal in-
         terviews with their debtors when this
         is feasible,  having  regard for  the
amounts involved and  the proximity
of agency representatives to such debt-
ors.

ffti FR 13MI. Oct. IS. 19«6. Redeattmted at
44 FR 22702. Apr. IT. 1979 and 46 FR 22353.
Apr. 20.1M1J

• 192.7 CMrtact  wttfc  debtor's employing
  When a debtor to employed by the
Federal Government or is a member of
the  military  establishment  or  the
Coast Guard, and collection by offset
cannot be accomplished hi accordance
with  5 UJS.C.  5614.  the  employing
agency will  be contacted for the pur-
pose of arranging with the  debtor for
payment of  the  indebtedness by allot-
ment or otherwise hi accordance with
section 206  of Executive Order 11222
of May 8. 1965.  3 CFR. 1965 Supp.. p.
130 (SO FR 6469).

t31 FR 13381. Oct. 18.1966. Redesignated at
44 FR 22702. Apr.  17.1979 and 46 FR 22393.
Apr. 20.19811
flt££  Suspension  or revocation of
        ! or eUgibiUtT.
II.
  Agencies seeking the  collection of
statutory  penalties,   forfeitures,  or
debts provided for as an enforcement
aid or for compelling compliance will
give serious consideration  to the sus-
pension  or  revocation of  licenses or
other privileges for any inexcusable.
prolonged  or repeated  failure  of  a
debtor to pay such a claim and the
debtor will be so advised. Any agency
making,  guaranteeing,  insuring, ac-
quiring, or participating hi loans will
give serious consideration  to suspend-
ing or dtffqyflinfylpg my tendg*! con-
tractor,  broker,  borrower or  other
debtor from doing  further business
with it or *"g»g<"g In programs spon-
sored by It If such a debtor fails to pay
its debts to the Government within a
       ible time and the debtor wfll be
so advised. The failure of any surety
to honor its obligations! in amf"**""***
with 6 U.&C. 11 is to be reported to
the Treasury Department at once. No-
tification that a surety's certificate of
authority to do business with the Fed-
eral Government has been revoked or
forfeited by the Treasury Department
will be forwarded by that Department
to all interested agencies.
                                            93
        11 artff

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Appendix
                                                                          Exhibit  A-A
 5 102.9

 131 PR 13381. Oct. 15.1966. Redtsignated at
 44 PR 2270Z Apr. 17. 1979 and 46 PR 22353.
 Apr. 20.19813

 910t9 Liquidation of collateral
 ,  i*a»ti»to« holding security  or  coUat-
' -era! which'may be liquidated and the
 proceeds  applied  on  debts due  it
 through the exercise of a  power of
 sale in the security  instrument. or a
 non-judicial foreclosure should do so
* by such procedures if the debtor fails
 to pay his debt  within a reasonable
 time after demand, unless the cost of
 disposing of the collateral will be dis-
 proportionate to its  value  or special
                                        .
        eluding liquidation of security or col-
        lateral, is not a prerequisite to requir-
        ing payment by a surety or insurance
        concern unless such action is expressly
        required by statute or contract.
        [31 PR 13381. Oct. IS. 1966. Redesignated at
        44 PR 22702. Apr. 17. 1979 and 46 PR 22383.
        Apr. 20. 1981]

        • 102.10  Collection in installments.
          Claims,  with  interest in accordance
        with  S 102.10 should be  collected  in
        full in one lump sum whenever this is
        possible. However,  if the  debtor  is fi-
                 unable • to ;jff r_
            Jn ;0ne 'Jump -?aumy jastynw
        be accepted  in regular Installments.
        The size and frequency of such install-
        ment payments should bear -a reason-
        able relation to the size of the debt
        and the debtor's ability to pay. If pos-
        sible the installment payments should
        be sufficient  in size and frequency to
        liquidate the  Government's claim in
            more than 3  years.
        payments of less than $10 per month
        holding an unsecured claim for admin-
        istrative fffllfrtion should attempt to
        obtain an  executed  confess-judgment
        note, comparable to the Department
        of  Justice  form  TJSA-TOa.  from  a
        debtor when the total amount of the
        deferred installments will exceed $750.
        Such notes may be sought  when an
                                 "
        ferred payments, other than a confess-
        judgment note, may be accepted in ap-
        propriate cases. An agency may accept
                                               installment payments notwithstanding-,
                                               the refusal of a debtor to execute a.:
                                               eonf ess-judgment note or to give other •
                                               security, at the agency's option.

                                               Bl PR 1338U Oct. 18. 1966. Redesifnated u
                                               44 PR 22702. Apr. 17. 1979 and 46 PR 22353
                                               Apr. 28. 19811                       -.Xii

                                               • 162J1 Exploration of compromise.     /
                                                Agencies wQl attempt to effect com-
                                               promises (preferably during the course
                                               of  personal  Interviews), of claims of
                                               $20.000 or less exclusive of interest, in
                                               accordance  with  the  standards  set
                                               forth tn Part 103 of this chapter in all
                                                    -in .which. i£ can  be ascertained
                                       not permit payment of  the claim  in
                                       full, or in which the lltigative risks  or
                                       the costs of  litigation  dictate such
                                       action;

                                       C31 PR 13381. Oct. 15. 1966. Redesignated at
                                       44 PR 23702. Apr. 17. 1979 and 46 PR 22353.
                                       Apr. 20. 19811

                                       • 102J2  Interest
                                         In the absence of a different rule
                                       prescribed by statute, contract, or reg-
                                       ulation. interest should be charged  on
                                       delinquent debts and debts being paid
                                       in installments in conformity with the
                                       Xreasnry   v-Vtacal    'Requirements
                                       VManuaL W«mtm-debtisT«id in mstan-
                                       ments. the Installment payments will
                                       first be applied to the payment of ac-
                                       crued interest and then to principal, in
                                       accordance with  the so-called  "U.S.
                                       Rule." unless  a different rule is pre-
                                       scribed by statute, contract, or regula-
                                       tion. Prejudgment interest should not
                                       be demanded or collected on civfl pen-
                                       alty and forfeiture claims unless the
                                                   *1* ••'toH ,fch» rtmlm 'f rjff«
                                                                    h inter-
                                       est. Bee Rodgers v. United States. 332
                                       U.S.37L
                                                                    ignated at
144 PR 29702. Apr. 17. 1979. R
46 PR 82353. Apr. 20. 1881]

• 102:13  Analysis of coats.

  Agency collection procedures should
provide  for  periodic  comparison  of
                                       covery rates for  debts  of different
                                       types and in various dollar  ranges
                                       should be used to compare the cost ef-
                                            94
FIFRA Co«pliance/Enforces*ent
                                             A-23
                      Guidance Manual 1983

-------
Appendix
                                           Exhibit A-4
        Chapter It—Federal doiim Collection Standards
        fectlveness  of  alternative collection
        techniques, establish  guidelines with
        respect to the points at which costs of
        further collection efforts are  likely to
        exceed recoveries, assist in evaluating
        offers in compromise, and establish
        pjirHrmim debt amounts below which
        collection efforts  need not be taken.
        Cost and recovery data should also be
        useful in Justifying adequate resources
        for an effective collection program.

        (44 PR 22702. Apr. IT. 1979. Redeslavated at
        46 FR 32353. Apr. 20.1981]

        B 112.14  Documentation  of atfmfaUitrati*e
           eoUectio* action.

          All  administrative collection  action
        should be documented and the bases
        for compromise, or for termination or
        suspension of collection action, should
        be set out in detail  Such  documenta-
        tion should be retained in the appro-
        priate claims file.

        (31 FR 13381. Oct. IS. 1966. Redesicnated at
        44 FR 22702. Apr. 17.1979 and 46 FR 22353.
        Apr. 20.19811

        9102.15  Automation.
          Agencies should automate their debt
        collection operations to the extent it is
        cost effective and feasible..
        (44 FR 22702, Apr. 17.1979. Redesii
        46 FR 22353. Apr. 20.1981]
»ted at
        6102.16  Prevention of overpayments, de-
            linquencies, and default*.

          Agencies should establish procedures
        to  Identify the causes  of overpay-
        ments, delinquencies, and defaults and
        the  corrective  actions  needed. One
        action that should be considered is the
        reporting of debts or loans, when first
        established, to commercial credit bu-
        reaus.

        C44 FR 22700. Apr. 17.1879. Redeslgnated at
        46 FR 22353, Apr. 20.1981]

        1102.17  Additional adminiatrative eoUee-
            tton action.

          Nothing contained in this chapter is
        intended to preclude the utilization of
        any  other  administrative  remedy
        which may be available.

        (31 FR 13381. Oct. 15.1966. Redeslgnated at
        44 FR 22702. Apr. 17.1979 and 46 FR 22353,
        Apr. 20.1981]
          PART 103—STANDARDS FOR THE
              COMPROMISf OF CLAIMS

        Sac.
        103.1  Scope and application.
        10X2  Inability to pay.
        103J  Utiaatlve probabilities.
        103.4  Cost of collecUnc claim.
        103 J  Enforcement policy.
        Itt.6  Joint and aeveral liability.
        iaj.7  Settlement for a eomblnaUon of
        103.8  Further review of compromiae offers.
        10L9  Restrictions

                        3. 80 Mat. 309: 31 UAC.
        952,
                 31 FR 13382. Oct. IS. 1966. unlen
        otherwife noted.
flt3.1  Sceteaadappl
  The standards set forth in this part
apply to the compromise of claims.
pursuant to section 3(b) of the Federal
Claims Collection Act of 1966. 80 Stat
309. which do not exceed $20.000 ex-
clusive  of interest, The head  of an
agency  or his deslgnee may exercise
such compromise authority  with re-
spect to claims for money or property
arising  out of  the  activities of his
agency  prior  to the referral of  such
claims  to  the   General  Accounting
Office or to the  Department of Justice
for litigation.  The Comptroller Gener-
al or his designee may exercise  such
compromise authority with respect to
claims  referred  to the General  Ac-
counting Office prior to their further
referral for litigation. Only the Comp-
troller General  or his deslgnee  may
effect the compromise of a claim that
arises out of an exception made by the
General Accounting Office in the ac-
count of an  accountable officer, in-
cluding  a claim against  the payee.
prior to its referral by that Office for
litigation.

I1BL2  Inability to pay.
  A claim may be compromised pursu-
ant  to  this part If the  Government
cannot collect the fuD amount because
of (a) the debtor's inability to pay the
full amount within a reasonable time.
or (b) the refusal of the debtor to pay
the  claim in full and the 'Govern-
ment's  inability  to enforce collection
in full within  a reasonable time by en-
forced collection proceedings. In deter-
                                            95
              -f arx-p/Rn-fr>rr<*»*MH'
              A-24
                      Guidance Manual  1983

-------
 Appendix
                                                                        Exhibit  A-4
.,\
§10X3

mining the debtor's  inability to pay
the  following factors, among others,
may be considered:
  Age and health of the .debtor; pres-
ent and potential income; inheritance
prospects; the possibility that assets
have been  concealed or improperly
transferred  by the debtor  the  avail-
ability of assets or income which may
be realised upon by enforced collection
piwanrflpgn The agency wfll give con-
sideration  to the applicable exemp-
tions available  to the debtor under
State and Federal law in determining
the  Government's ability to enforce
          Uncertainty:** to the price
vhteh ooDaCeral Brother property v
bring at forced sale may properly  be
considered in determining the Govern-
ment's ability to  enforce collection. A
compromise effected under this sec-
tion should be for an amount which
bears  a reasonable  relation to the
amount which can be recovered by en-
forced collection  procedures, having
regard for the exemptions available to
the debtor and the time which collec-
tion will take. Compromises payable in
installments  are  to  be  discouraged.
However, if payment of a compromise
by installments is necessary, an agree-


thereon  and acceleration* of the bal-
ance due upon default in the payment
of any installment should be obtained,
together with security in the manner
set forth in i 102.8 of this chapter, in
every case in which this is possible. If
the agency's files do not  contain rea-
sonably  up-to-date credit information
as a basis  for assessing a compromise
proposal such Information may be ob-
         penalty of perjury showing the debt-
         or's assets and liabilities, income and
         expense. Forms such as Department of
         Justice  form DJ-35  may be used for
         this purpose, similar data may be ob-
         tained  from  corporate  debtors  by
         resort to balance sheets and such addi-
         tional data as seems required.
           A claim may be compromised pursu-
         ant to this part if there is a real doubt
         concerning the  Government's  ability
         to prove Its case in court for the full
                                                                  THto 4-Accoyntr
                                                                                .*"••*
                                               amount claimed either because of the
                                               legal issues involved or a bona fide 
                                               -pute as to the facts. The amount ac-
                                              . cepted in compromise in such- cases-
                                               should fairly reflect the probability of
                                               prevailing on  the legal  question in-
                                               volved. the  probabilities  with  respect
                                               to full or partial recovery of  a judg-
                                               ment  having due regard  to the avail-
                                               ability of witnesses and other eviden-
                                               tiary  support  for the  Government
                                               claim, and related pragmatic consider-
                                               ations. Proportionate weight should be
                                               given  to the probable amount of court
                                               costs  which may be assessed  against
                                               the Government If* is unsuccessful in
                                               litigation, baring regard for the litlga-
                                               tive risks involved. Cf. 28 U.S.C. 2412.
                                               as amended by Pub. L. 89-507, 80 Stat
                                               308.

                                               »1«&4 Cost of  collecting claim.

                                                 A claim may be compromised pursu-
                                               ant to this part if the cost of collecting
                                               the claim does not justify the enforced
                                               collection of  the full amount The
                                               amount  accepted  in compromise in
                                               such eases may reflect an appropriate
                                               discount for the administrative and 11-
                                               tigative  costs  of  collection  having
                                               regard for the time which it will take
                                              - to :etteet caUectlnn. Caat of eoileetmg
                                              -way tee^^snnstantha factor to-ttoe set-
                                               tlement of small claims. The  cost of
                                               collecting claims  normally wfll not
                                               carry  great weight in the settlement of
                                               large
                                      • 10X5  Enforcement policy.
                                        Statutory penalties, forfeitures, or
                                      debts established as an aid to enforce-
                                      ment and to compel  compliance may

                                                                       .in
                                      terms of deterrence and securing com-
                                      pliance. both present and future, wfll
                                      be adequately served by acceptance of
                                      the sum to be agreed  upon. Mere acci-
                                      dental or technical violations may be
                                      dealt with less  severely than  willful
                                      and substantial violations.
                                                                   e lotat-
                                      ly and severally liable collection action
                                      wfll not be withheld against one such
                                      debtor until  the other or others pay
                                      their proportionate share. The agency
                                            96
  FHFRA. Compliance /Enforcement-

-------
Appendix
                                               Exhibit A-4
        Choptw II—Federal Claims CoOactfafi Standard*
                                          f 100
       'should not  attempt  to  allocate the
        burden of paying  such claims  u be-
        tween the debtors  but should proceed
        to liquidate the indebtedness as quick-
        ly as possible. Can should be taken
        that compromise with one such debtor
        docs not release the agency's daim
        against  the remaining  debtors. The
        amount of  a compromise with  one
        such debtor shall not be considered a
        precedent or as morally binding in de-
        termining the amount which win be
        required  from  other debtors  jointly
        and severally liable on the claim.
        9103.7  SctUeowfit  for a
ibbutio*  of
  A claim may be compromised for one
or for more than  one of the reasons
authorized in this part.

9103.8  Further  review  of  cosBS-ranisc
   often.
  If an agency holds a debtor's  firm
written offer of compromise which is
substantial in amount and the agency
is uncertain as to whether the offer
should be accepted,  it may refer the
offer, the supporting data, and  par-
ticulars concerning the- claim to the
General Accounting  Office or to the
Department of Justice. The General
Accounting Office  or the  Department
of Justice may act upon such an offer
or return it to the agency with instruc-
tions or advice.

I10&9  Restrictions.
  Neither a percentage of a debtor's
profits nor stock in a debtor corpora-
tion will be accepted  in compromise of
a claim. In negotiating a compromise
with a business concern consideration
should be^given to requiring a waiver
of the tax-loss-carry-forward and tax-
loss-carry-back rights of the debtor.

PART  104—STANDARDS  FOR  SUS-
  PENDING OR TERMINATING  COL-
  LECTION ACTION

See.
104.1 Scope and application.
104.2 Suspension of collection activity.
104 J Termination of collection activity.
104.4 Transfer of claims.
  AuTHomrrr See. 3.  80 Stat. 309: 31 ttS.C.
992.
              Sooacr 31 FR 13383. Oct. IS. 1988. unless
             otherwise noted.
             §184.1
                appHeathm.
              The standards set forth in this part
             apply to the suspension or termination
             of collection  action  pursuant to sec-
             tion Kb) of the Federal Claims Collec-
             tion Act of  i960.  80 Stat.  309.  on
             claims which do not exceed $20.000 ex-
             clusive of interest. The head of an
             agency or his designee may suspend or
             terminate foOt^far action under
             part with respect to claims for money
                     rty arising out of activities of
his agency prior to the referral of such
fi^i^n*  to th*  General  Accounting
Office or to the Department of Justice
for litigation. The Comptroller Gener-
al or his  designee may exercise such
authority with respect to claims re-
ferred  to the  General  Accounting
Office prior to their further referral
for litigation.
                                              9184.2 *8wft niton of ceflcctk
                                         etivtty.
                                               Collection action may be suspended
                                              temporarily on a  claim  when  the
                                              debtor cannot be located after diligent
                                              effort and  there is reason to believe
                                              that future collection action may be
                                              sufficiently productive to Justify peri-
                                              odic review and action  on the claim
                                              having consideration' for its  sbse and
                                              the amount which may  be realized
                                              thereon. The following sources may be
                                              of assistance in I'Mftlfig m fterfng debt-
                                              ors: Telephone directories: city direc-
                                              tories; postmasters; drivers' license rec-
                                              ords; automobile title, and license rec-
                                              ords;  state  and local  governmental
                                              agencies; district directors of TntmuU
                                              Revenue; other Federal agencies; em-
                                              ployers,  relatives,  friends;  credit
                                              agency skip locatf reports y** credit
                                              bureaus. Suspension as to a particular
                                              debtor should not defer the early liq-
                                              uidation  of security for  the debt.
                                              Every  reasonable  effort  should be
                                              made to  locate missing  debtors suffi-
                                              ciently in advance of the bar of the ap-
                                              plicable statute of limitations, such as
                                              Pub, I*. 89-805. 80 Stat. 904. to permit
                                              the timely filing of suit  if such action
                                              is warranted. If the mining debtor has
                                              signed a confess-judgment note and is
                                              in default, referral of the note for the
                                              entry of  judgment should not be de-
                                              layed because of his missing status.
                                           97
 FIFRA  Co»pliance/Enforcea*ent
                   A-26
                                                                 ance
                                          1983

-------
Appendix
                                                                                 Exhibit A-4
        51043

        Collection action may be  suspended
        temporarily  on  a  claim  when  the
        debtor owns no ffv^fftflntlnl equity in
        realty and is unable to make payments
        on the Government's claim or effect a
        compromise i thereof > at the time but
        his future prospects Justify retentions
        of the claim for periodic review and
                                                                                '.*ss
          (a) The applicable statute of limita-
        tions  has been tolled or started run-
        ning anew or (b) future collection can
        be effected by offset notwithstanding
        the statute of limitations.
        (31 PR 13381. Oct. 15. 196«. aa amended at
          The head of an agency or his desig-
        nee may terminate collection activity
        and consider the agency's file on the
        claim  closed  under  the following
        standards:
          (a) Inability to collect any tudttan-
        tial amount Collection action may be
        terminated  on a claim when  it be-
        comes clear that the Government
        cannot collect or enforce collection of
        any significant sum from the debtor
        having due regard for the Judicial rem-
        edies available to the Government, the
        debtor's  future  financial- prospects.
           i the . •
                                                When an  agency has doubt as to
                                             -.whether collection .action should be
                                             • ..^MJia«»«iaH jpr. t»t itttrtm+m* qp a. CJSiPj it
                                              may refer the claim to the General Ac-
                                              counting Office for advice. When a sig-
                                              nificant enforcement policy Is involved
                                              in reducing a statutory penalty or for-
                                              feiture to Judgment, or recovery of a
                                              Judgment is a prerequisite to  the im-
                                              position of  administrative sanctions.
                                              such as  the suspension or revocation
                                              of a license or the privilege of partici-
                                              pating  in a Government sponsored
                                              program, an agency may refer such a
                                              claim for litigation even though termi-
                                              nation of collection activity might oth-
                                              erwise be given consideration under
                                             .1.104.3 UO JOT icX^CTitmvan wnich an

                                              ment -or otherwise wHl be referred to
                                              the Department of Justice for further
                                              action if renewal of the Judgment lien
                                              or enforced collection proceedings are
                                              Justified under  the criteria discussed
                                              in this part, unless the agency con-
                                              cerned  has  statutory  authority for
                                              >i^nrfnny its own litigation.

                                                PART 105—REFBUAIS TO GAO OR
                                              109.1  Prompt referral.
                                              108.2  Current address of debtor.
                                              10S.3  Credit data.
                                              105.4  Report of prior collection action*.
                                              105.8  Preservation of evidence.
                                              109.6  Minimum amount of referrals to the
                                                 Department of Justice.
                                                              aao.

                                                              li«» Btat *«* <*! TTB.C.
                                              952.

                                                BOOTTCE 31 PR 13384. Oct. IS. 1966. unless
                                              otherwise noted.
                                            98
FIFRA
                     /Bnf orcr m1 ut
A-27
Guidance
1983

-------
Appendix
                                  Exhibit A-4
        Chapter II—Federtri Claim* Coltetfaa Standards
                             $105.6
        9 1*8.1  Prompt referral
                 on which  collection  Action
             been taken  in  accordance with
        Part 102 of this chapter and  which
        cannot be compromised, or on which
        collection action cannot be suspended
        or  terminated,  in  accordance with
        Parts 103 and 104 of this chapter, wfll
        be referred to the General Accounting
        Office in •accordance with R& 236. as
        amended. 31 U-S.C, 71. or to the De-
        partment of Justice, if the agency con-
        cerned has been granted aa exception
        from referrals to the  General Account-
        ing Office.  Such referrals should be
        made as early as possible consistent
        with  aggressive   agency  collection
        action and the observance of the regu-
        lations contained in  **<<« chapter and
        in any event well within the time lim-
        ited for bringing a timely suit against
        the debtor.

        §10&2  Current address of debtor.
          Referrals to the General Accounting
        Office, and to the Department of Jus-
        tice for litigation, will be accompanied
        by the current address of the debtor
        or the name and address of the agent
        for  a corporation upon whom service
        may be made. Reasonable and appro-
        priate steps  wfll  be taken to  locate
        missing parties in all cases. Referrals
        to the General Accounting Office, and
        referrals to the Department of Justice
        for  the institution of  foreclosure or
        other proceedings, in which the cur-
        rent address of any party is unknown
        will be accompanied by a listing of the
        prior known addresses of such a party
        and a statement of the steps taken to
        locate him.

        HtftJ  Credit data.
              •JCn.
          (a) Claims referred to the General
        Accounting Office, and to the Depart-
        ment of Justice for litigation, will be
        n^T*ompf p1*i* by  reasonably current
        credit data indicating that there is a
        reasonable  prospect  of effecting  en-
        forced collections from the debtor.
        having due regard for the exemptions
        available to  the  debtor under State
        and Federal law and the Judicial reme-
        dies available to the Government.
          (b) Such credit data may take the
        form of: (1)  A  commercial  credit
        report.  (2)  an  agency  investigative
        report showing the debtor's assets and
liabilities and his  income  and  ex-
penses. (3) the individual debtor's own
ftfif fi**1fil  tt***i"fflt executed under
penalty of perjury reflecting his assets
and liabilities and his income and ex-
penses, or (4) an audited balance sheet
of a corporate debtor.
   Such credit data may be omitted
ifc (1) A surety bond to available in an
amount sufficient to satisfy the dalm
in fun. (2) the forced sale value of the
security  available for application to
    flitvmn \vn»nj'f rtmtm Jg fUffJCJPnt
to satisfy its dalm in fun. (3) the re-
ferring agency wishes to liquidate lorn
collateral through Judicial foreclosure
but does not desire a deficiency Judg-
ment. (4) the debtor to in bankruptcy
or receivership, or (8) the debtor's lia-
bility to the Government to fully cov-
ered by  insurance, in which case the
agency wfll furnish such information
a* it can develop concerning the Iden-
tity and address of the insurer and the
type and amount of insurance cover-
age.

§ 108.4  Resort of prior collection actions.
  A checklist or brief summary of the
actions previously taken to collect or
compromise a claim wfll  be forwarded
with the claim upon its referral to the
General  Accounting Office  or to the
Department of Justice. If any of the
administrative collection actions  enu-
merated  in Part  102 of  this chapter
have  been  omitted, the reason for
then- omission wfll be  given with the
referral.   The  General  Accounting
Office and the Department of Justice
may return or retain claims at their
option when there to insufficient Justi-
fication  for  ****  omission of vnf or
more  of  the ^<*TT**T1<*trattvf collection
actions enumerated in Fart 102 of this
chapter.
llt&S

  Care wfll be taken to preserve aU
files, records and exhibits on claims re-
ferred or to be referred to the General
Accounting Office, or to the Depart-
ment of Justice for litigation.

fl 105.*  Minimum amount of referrals to
   the Department of Justice.

  Agencies will not refer claims of less
than $600. exclusive of interest for liti-
                                           99
FIFBA Govpllance/Enforcenent
     A-28
Guidance Manual  1983

-------
Appendix	              Exhibit A-4
       5105.7                                               1W»

       Cation unless: (a) Referral is impor-  1106.7 Referral* to GAO.
       tant  to a  significant  enforcement •  p,r..- _i, „» .1-1—. »-,
       policy or  the debtor harnot only
       the clear ability to pay thedaim but
       the •Government -can elfecnv«iy ea-
       under State or Federal Law and the
       judicial remedies available to the Gov.
       eminent
       £43 FR 38891. Aus. 1.19773
                                        100
FIFKA Gbapliance/EnforceiKnt              A-29           Guidance Manual 1983

-------
Appendix	Exhibit A-5


                      Model Demand for Payment Letter
      Name:                                       Date:
      Address:
      I.F.&R. No.:
      Demand for Payment of  Civil Penalty - Warning For Failure to Pay

      Dear Sir/Madam:

           In connection with  the enforcement of the Federal Insecticide,
      Fungicide, and Bodenticide Act,  as amended (7 U.S.C. J136 et seq.),
      you are hereby given notice that your penalty payment of
      $ ______^^_ is due within thirty (30) days and that we expect
      payment in full before the expiration of the sixty (60) day payment
      period that started on	and ends on	

           If payment is not received  by the  expiration of the payment
      period, this matter shall be referred to the (United States
      Attorneys Office/Department of Justice) which shall recover such
      amount by civil action in the nature  of a debt owed to the United
      States government.

           In the event that you have  already submitted your payment
      or that it is currently  in transit, please disregard this
      notice and accept our  apologies  for any inconvenience it may
      cause you.
                                      Title

                                      EPA Region
                                              Date         At
FIFRA Compliance/Enforcement             A-30          f^ridi'w* Manual 1983

-------
Appendix
                       adhibit A-6
                   Model Final Demand for Payment Letter
     Name:
     Address:
     I.F.&R. No.:
       Date:
     Final Demand ^or -Payment  of  Civil  Penalty - Notice of Referral
     to  the U.S. Attorney

     Dear Sir/Madam:

          This  letter  is  to Inform you  that  your penalty payment of
     $ _______     is past due and to  demand immediate payment of the
     above-mentioned sum.  The penalty  was Imposed by a (Final Order,
     Consent Decree, or Default Order)  signed by ±ne Regional
     Administrator  of  "Region  	on     (date)   .  You were
     notified of your  obligation  to pay upon receipt of the Regional
     Administrator's  order on
   and you were again  informed
     of your obligation to  pay on    (date second demand was sent)  «

          Tou  are  hereby notified  that  unless  the payment of the penalty
     is received in  the Regional Office within fifteen (15) days of the
     date of this  notice, this matter will  be  referred to a U.S.
     Attorney  who  shall recover such amount in a civil action in the
     appropriate United States district court.  Such action is routinely
     accomplished  through a motion for  summary judgment in favor of
     £be United £ta£es. In, this proceeding, yon^vill be barred from
               y -Ln&tm of  fact or i«f Ixa sthst «b»uld fc*ve 4>een raised
     in the administrative  proceeding.
                             Title

                             IPA Jtegion
                                 . •**   **
                                      Date
            At
FIFBA OoapH ance/Knforcement
A-31
Guidance
1983

-------
Appendix
                           Exhibit A-7
                       CLalns Collection  Litigation Report
                                    An Overview
              The  Federal Claims Collection  Standards (4  C.F.R.  $$101-105)
         prescribe  regulations  for  the administrative collection,  compro-
         mise and  termination of agency  claims,  and  for the  referral  of
         administratively uncollectible  claims to  the General  Accounting
         Office or  to  the Department of  Justice  for  litigation.  The
         Standards -require  that certain  information" be provided  to
         the Department of  Justice  when  an agency  refers  a claim for
         litigation and enforced collection  (4 C.F.R. $105.1 et  seq.).
         In cooperation with the General Accounting  Office,  tKe" attached
         Claims Collection  Litigation Report (CCLR)  has been developed  by
         the Debt Collection Section of  the  Executive Office for Onited
         States Attorneys,  Department of Justice,  as the  standard  report
         to provide this information when claims are referred  to Justice
         for litigation and enforced collection.   All claims referred to
         Justice should be  accompanied by a  completed report.
              The CCLR is provided  in three different  formats:   letter
          (Exhibit 1), memorandum  (Exhibit  2), and  standard  form (Exhibit
          3).  Each agency may choose the format  it prefers  to use.   Dupli-
          cate copies of each format which  include  bracketed explanatory
          text are also provided (Exhibits  4, 5 and 6).*  In  addition,  an
          Item Explanation (Exhibit  7) is provided  to assist and direct
          agencies on the specific information required in each  item  on
          the report.

              Uniform use of -the CCLR by all agencies  will  serve a
          number of purposes.  First, it will provide Justice with all
          the information it must have to effectively litigate the claim
          and enforce collection.  The CCLR will  provide  this essential
          information "on top -and up front" so that no  time  will be lost
          searching the client agency's file for  the necessary informa-
          tion.  This will increase  the speed at  which  claims received
          from agencies are taken to judgment, or otherwise  converted  to
          paying status, and, as a result,  should increase the amount  of
          money collected by Justice and returned to the  agencies.

              Second, the CCLR should improve the  quality of claim
          referrals to Justice by prompting agencies to take more aggres-
          sive administrative- action to collect claims.   Such aggressive
          collection action is required by  the Federal  Standards (4 C.F.R.
          iioart^et seg.) but has often been overlooked or ignored.   Zn
          this respect, the CCLR will also  serve as a checklist  and as
          a reminder to all persons who deal with these matters  of the
          importance of the Federal requirements.   Furthermore,  both
          aggressive action by the agency to collect and  prompt  referral
          to Justice of claims which are accompanied by current, accurate
         •and complete information, directly affect Justice's success in
          the enforced collection of claims.  Therefore, we hope that
          each agency will establish the goal that  all  of its referrable
          claims be referred to Justice not later than  six months after
         * The Pesticides and Toxic Substances Offices  have adopted the
           memorandum format.  Therefore, Exhibit 5  (&e  memorandum format
           that includes bracketed explanatory text)  is included in this
           appendix.  Exhibits 1, 2, and 3  (blank forms)  and Exhibits 4
           and six, which pertain to other  formats,  are not included.
FIFRA CoBpllance/Enfor
A-32
                                                             Guidance .Uteniui 1 10ft?

-------
Appendix	Exhibit A-7
           the  agency's final  determination of the amount of the claim.
           It,  am  stated in the Item  Explanation,  preparation of the CCLR
           is1 «ade an  integral and  contemporaneous function of aggressive
           collection  efforts  by all  agencies, the CCLR will be completed as
           and  when the agency completes  administrative collection action,
           thus, allowing agencies  to promptly, refer claims to Justice.

               Finally, the CCLR will  provide the information needed by
           Justice from all agencies  in the same order and sequence.  This
           will enable Justice personnel  to design procedures around the
           report  which will permit better  utilisation of the modern word
           and  data processing equipment  which many law offices now have.
           Once .the information is  received in the same sequence, then
           prerecorded programs will  enable such equipment to "read" each
           •debtor file" to "automatically* produce the documents essential
           to litigation, for  example,  the  demand  letter, complaint, summons
           and  judgment, which relate to  a  claim.   Such automated collec-
           tion* ^yatmms «ill  improve.the mtficleney and speed with which
           ciaimsmre  handled  aad«',
-------
 Appendix	Exhibit A-7
                         itemization of the dates and amounts of any payments
                         made by the debtor to the agency or any credits made
                         by the agency to the debtor, and an itemization of
                         the amount due and owing) and which may be offered by
                         the United States Attorney into evidence to prove the
                         claim;

                     2)   A Department of Justice Demand Letter (Exhibit 8)
                         which will be used by the Onited States Attorney to
                         notify the debtor that the Department of Justice has
                         received the claim for litigation and suit will be
                         brought unless full payment is made within 10 days
                         (please note that this letter need only be prepared
                         and included in the CCUt package for those Onited
                         States Attorneys' offices listed on the Attachment
                         to Exhibit 8);

                     3)   A Department of Justice Acknowledgment ('Comeback
                         Letter") (Exhibit 9) which will be used by the
                         Onited States Attorney to officially notify the
                         agency that the claim which was referred has been
                         received and will give the referring agency the
                         Onited States Attorney's claim number) and

                     4)   A Department of Justice Deficiency-or Declination
                         Letter ("Sendback Letter*) (Exhibit 10) which will
                         be used by the Onited States Attorney to send
                         deficient claims, or claims which the Onited States
                         Attorney declines to litigate, back to the agency.

           The  letters should be prepared in the same format reflected in
           the  exhibits.

                The  Department, of Justice solicited comments on the use, con-
           tent and  format of the report from divers Federal agencies.  These
           comments  expressed 'almost universal support for the concept of the
           report.   To the extent possible, all agency suggestions for changes
           to the  report, or that additional items be included in the report,
           were incorporated.  Several agencies were concerned that some of
           the  items of  information requested on the report may be superfluous
           to their  particular claims or impossible to obtain.  Inability to
           obtain  all information required by the report should not be viewed
           as a bar  to referral of claims to Justice.   However, information
           requested in  the litigation report should be provided to the extent
           feasible. Questions of feasibility should be answered on the basis
           of and  with a  clear understanding of the fact that claims referred
           to Jtfrtice are for litigation following aggressive administrative
           collection action oy the referring agency,  and that on the basis
           of the  information contained in the CCLR, Including ThYTgency's
           determination  ot the deDtor¥s~"abTTT'ty to pay* and the accompanying
           supporting documentation or agency debtor file.  Justice should
           be able to successfully prosecute the claims referred  to it
           to judgment and enforce collection of £ substantial sum.   Any
           omissions should be explained in the appropriate item on the
           face of the report.

                                          -3-
FIF1A Compliance/Enforcement               A-34

-------
Appendix	_____	Exhibit A-7
                We realize that  M agencies gain experience using the CCLR,
           problems may arise  which could not be foreseen while the report
           was  being developed.  Although completion of the report is
           required, its content and format may be modified in the future
           baaed upon any commits or suggestions from agencies using
           the  report.   Comments should be brought to the attention of
           Mr.  Edward B. Puna ton, .Assistant-. Director, Debt Collection
           Section,; Executive  Office, for 0. S. Attorneys, Suite 803,
           5205 Leesburg Pike, rails Church, Virginia 22041.  In the near
           future,  the General Accounting Office will incorporate the CCLR
           and  accompanying materials in Title 4 of the General Accounting
           Office Policy and Procedures Manual for the Guidance of Federal
           Agencies.
                                         -4-
FIFRA Goapliance/Eoforceaent               A-35          Guidance *a«"^l  1983

-------
Appendix
                                                                      Exhibit  A-7
                                                                                              >*<
                                        CLAIMS COLLECTION LITIOATION
                                        (OB MBDTMM of rvfwrlng «go»cy)
                                                           XDrMI
            Tot XWItW» STvtSS
                XJudicial  District) of ISt*t.
                                            u tlw lotil limrwt *•.
                                            !• tto torvl Mlalrfrotlva
                                                                   I     Is tfta total  poMlty
                               Xtatcl
                                                                        !• ttw tvtvl  mem
                                                                        li *» •MM*)  lirt«r«t
                                                                        l« t*« JOt «•*».
                 TkU elala I* r«fvr« 1e yo« fer suit «M Mdi otMr •etloi a yai ««• ^pro»rl«t» to
            wfarei CDllaetlan.  HM prior action IMM by ml* agowy Md tta lnforwtlo* «ro»l«od yon o
            pil« fully «ritt> r«MT»l Cl«l« ColloetloH StanMr4« (4 Cflt tarts 101-109).  n» tttmmftmttm
                    til 4 CM ftrts l«-4fB !• sttMsari *M th» Inforwrioii you ••«• isausatx fol low.
             I.  Os*» of UPHII
                                                         2.  Social  Saearlty
             3.  Als*
                 ILIst
                                         o> iat«/«p»lleatlait
                             of oseter. If
                 t*aa» actual slaes of raaldsaea. not
                                                                     varlflad
                                                         7.  »H
wrlflad ky/Mioai
            Tl
                                                         t.  Ostrtar lusoM  UMstrwls«])
                                                            I8>o» l»f
-------
Appendix
Exhibit A-7
>t<
/
%
11. Stifuta of llaltatleaa (SOI) rum on:
(Data?]
(12. ccat'd.)

13. tlrtt oaaaa* tar aaMant aaa» ant
lOatatl
15. Mrrtio* of f lr«t danaf*:
IC.Q.. toftar. ••! lor «TI
17. U»t Maaad aada byt
J*iO|Jjakagant. official, off teat)
• J», ™0a*«or;.» raaacaaaj . •
.- .. • Sjjgg^jg^jgLilMJSlSlLSBSSlLm— • -
(20. eant'dt> to tt» clala. If know. 1

21. Haapanaa, If aay, to dabtor's dlspvta*
1 /tenner rdabonaa to daMer*! dl>out«.l
j22Leent'«.) »««l(*bU to «Mter. HOB «•
• Itti r«a«rd tlMrcto. If «iv.l
23. CoBproBlw of f«r«* w «l leltM:
HOaotattl
<24. conr'a.) Tt» tfabtor or effarad tt» «
macro* !«• offer 9l««n: If w. vtat MS
23. RaaaonsB by loancy or 4atof)ofs


aaauirr r«eo»»r«dT 61 «• orfwr r»(«v«nt  of (Orr» of datmiliwtloii.l
30. Tbtil (MMMr/aMMit of pafBMts
• • -- -..mj&m KI CM
32. AaDunf appllod to elMroai anasMd*
pMBltlo* «M latarwti
S
•MMltlot «d aceruM Intararri
S
n* rrnt'd.l iiatttir ara IB ta MODI ltd. 1
' '
36. OaotorU last payaant;
SlAaount and dataTI
C
>T< tt<
12, BMU for SOL datat
(£,2lj oafault drfa. lait pa»aanf datal


14. plr»t «aaaad aada byi
(Mho, t,«v aaiairr. official^ offleaT)
f«W &4W^ ^••xid for pfltyMWf »ba) OHI
lOataTI
It. Mttiod of laat aaaandt
|E.a.. lattar. otana. ooraonal eantarTTI
,20. >aaa»- aittur 4J a»ta «l«<«i

22. Bdwwtlon of ad*lal«lratl«* roaadla*:
{Daaerlba adalnlstratlva raaadloi
6tw Ma advlaad of UMB. and oabtor** aerlon

24. taala for eoavoBlMi
{•at • eeaoraalia offor alleltad fro*
•totor by tHa claimant aoonevT Wat • basis for
Tfia beslstl
2ft. Othvs logally rasaoislbla for dabt:
I£^Q, . banaf Iclarl-n CdHlir'i itors. 1
I'M 'Ttwmty Whir «r -MMrarT (kcMon,
• fm | ffltfty not 7 1 f vaM *mt scT Ion And wtut
tillm.l i
fOHOION
29. Original principal oMd by dabtor:
SIAaaunfTI
31. AaaaiT apfllad to arlncipali
• *
33. Balanca dua oa principal:
t
33. faplaln application of aaMantu
(b^laln ho* aivawits roealMd froa tt»


37. lotvast accrual tfatai
fTl»a data from •ftlctt Intaroit Is dua.i
-2-
Haao) .
4
                                         A-37
Guin
   «I 1983

-------
Appendix
                                                                                              Exhibit  A-7
                                                                               tl
                                                                    ry«
                 City. St»t« am ZIP Coa«M
                                                                             UlY
                  [faiilriyar't OOP* m«O«rtl
                                                                           n«Ttl
             41.  Mary *vifi«>
                                                                       T|
                                                          llaoloor'i anoo«
                                                «Mirrr 10 mr
                  lEnlaln. I	__^
             49. Tto teMocl
                     a»«crlb» «nd
                                   loi »IH M*I*T y«« In looting
                                             lootleo of
                                                                     In Mlett Tta U»ltM St*«M
                                                              In •ftloi
                 v«lu> a» ar
             47.  It
   or Mid In uammut, tta fair avMrr
Enelaln M«l« «ar f»lr •»•»»» or ««MT
                                                                   V«IM o» nil* el*la wault Mi
                                                               loa alvxi. If any.; _
                 Mtk *• raojr*
                 rM»an«ll«
                 lltmtil
               •• aBlllty « pay. M •tfliw* by
           !• coMroilM offer by TM >»tj MU!« k»i
                           6«Dl«ln In raHflomBlo
                  IMnntlm offlcirt
                  •M»». tlTU. «o»«ey. ••Ulna
                 £3.
                                             m>tliia/«l«BW»l«s off lor
                                             /••Mr:
                                                          91.
                                                                        'S^afM flaproprlof loii
                                                    -J-
 FIFRA Gcmpliance/Eoforceaent
                                    A-38
uiane
1983

-------
Appendix
                                                                                   Exhibit A-7
                 It I con bo of o»y fyrThor oulftoneo in ml* •error, »100*0 do not hooltrro to coll oo
             •t to* ivokor glvo* okcv*.
                                    > tor «*M*lt*g .too.CUtat
                >rritui
                >irn
                Th» ij»nli. Tt» brockets, tn* •*•«. or ft* tvrt >ltkla *ltMr of tt»  l«nw .III  not
                miMT a* «• flMl tf»M or prlm*d report, but tmn kMn l»clu*M koro to •xpldn or
                clarify «• ojMtloac/lf«&.  Tho mryln «M tM •ttlnes cro HMIcato* ea fho flrct
                MM. »e» wr. tt»y MM not k» eMngM «• a*l«t» t*» wrlr* roporr.  Dili mart
                •It* «rrt»ni l*«»r*) t»«t om irut.
Tko QMroji en too flror p»go U txo •Inilo* ottrou* Mr toj
o oMroM.*!  Ibo JuOlelw tlitrlcr aoy bo «-irro«
or -Olttrlcr of Konooo,* oo opprorl«r». HM Sroto OM bo too
lartor oBbrovloripn.	^^^_
                                                                       Olopo or •ouTtld*
                                                                          Olttrler of ta
                                                                     •ceooroo: 1*0 c*»lt«i
FIFRA  Oovpllance/Baforceaent
                                               A-39
1983

-------
Appendix             	   	         	  Exhibit A-7
                                       OCTAILB.
           If mn tfuet it
                fclxl ma» 5.
FXFRA Goapllance/Eoforceaent              A-40          Guidance Manual  1983.

-------
Appendix
                                                                        Exhibit A-7
                              GADS


                               Itaa ani
                                                   ion
CUiaa ttOKetion TJf Igatlm
                                           (OCLB)
                                                              provtda t&a
        CUiw CeAlactilbn stana«na«JT"C.y.iU iSlOl-TQg)


           ia^™1^1K-x^™               W
                                                                        claia .
                                                                       iadiatiag ttue
Ability to Ifcy*
                                                                       OB a oultipl*
                                                                      oC £Msibillty
                          en tat boil of «d witt a elMT iBteBStaoding of tot fact
        tnat cLii«« xaftoad to
                                   ion contain*! in tna
tlon of a aueitaBtial
                                                                  ataouldb> abla to

                                                                  £  ^a^hfl *** l^a^B 1

        potot a«g«ly ppogida a ggning liat of only tba


        aBMBMl ^•bAf»;4^Ht •Amltft M^aVt P^tt t^B^a4 P*tf M^k aw^aVMW AM 4*^

                  ttaa  aiaiiai'i in ttaa nmin? liat.  ttan a xopniaf liit ia previdad in
 FIFRA  Goopliance/EoforceMnt
                                            A-41

-------
Appendix          	Exhibit  A-7
         lieu of inserting tfce answer* onto the actual report form,  however,  great car*
         should be taken by tht agency to assure that tht Item numbers and answers pro-
         vidad in the running list imtesujuJ to the Item numbers on the report.   This
         method of providing information should both sinplify and expedite the agency's
         preparation of the OCLR.  In addition, it should allow for  better utilization
         of available word and data processing equipment to prepare  the report.

              M both the OCLR and the following explanations state, all documentation
         which supports the claim or, where appropriate, the agency's debtor  file should
         be attached to the report.  In addition, the following materials should  be
              red and included in the OCLR
                   1)  A Certificate of Indebtedness which will provide the United  States
                       Attorney with a complete statement of how the claim aroee (including
                       the statutory, regulatory, or other authority from which the claim
                       arose, a summary statement or resume of the factual basis for the
                       claim, an itemization of the dates and amounts of any payments nude
                       by the debtor to the agency or any credits made by the agency to the
                       debtor, and an itemization of the amount due and owing) and  which
                       may be offered by the United States Attorney into evidence to prove
                       the claimj
                   2)  A Oepattaenl of Justice Demand better (Exhibit 8) which will be
                       used by the United States Attorney to notify the debtor that the
                       Department of Justice has received the claim for litigation and
                       suit will be brought unless full payment  is aade within 10 days
                       (please note that this letter need only be prepared  and included
                       in the OCLR package for those United States Attorneys'  offices
                       listed on the Attachment to Exhibit 8);
                   3)  A Depenaenl of Justice Acknowledgment (•Comeback Letter")  (Exhibit
                       9) which win be used by the United States Attorney to officially
                       notify the agency that the claim which was referred  has been
                       received and give the referring agency the United states Attorney's
                       claim number} and

                   4)  A Dnau.lme»L of Justice Deficiency or  Declination Letter (Exhibit
                       10) which will be used by the United States Attorney to send defi-
                       cient claims, or claims which the United states Attorney declines
                       to litigate, back to the agency.

             letters should be prepared in the same format reflected in the exhibits.


                                           TOP FOHTXCN

                 ,*H         Date:               Show the date  that the OCLR  is signed.

                  Inside Address               Slnply show "United States Attorney," the
                   or To" Block:               Federal judicial district, and the city,
                                               state and zip  code.  The judicial district
                                               may be written, "Southern District of Iowa,"
                                               or "District of Kansas," a* appropriate.
                                               The state can  be the accepted two


                                                -2-
FXFBA  flnggpi < anff*/Hnf<>T^^aent                 A-42             t±rtjpnff Manual 1983

-------
Appendix
                                           Exhibit  A-7
                                           letter abbreviation.  A complete nailing
                                           address far the united States Attorney
                                           should be provided on the nailing envelope.
                                           (Exhibit 11 provides cm-rent nailing
                                                     oar united States Attorneys.)
                 "near Block:
           Debtor's Pull Nan:
             Debtor's Nailing
                      Address:
             Debtor's File or
             Reference Nunber:

          Total Principal Due:
 (When  using  the  "NenorandutT or  "Poem* for-
,nat]   Show .the nane,  title, complete nailing
 address and  PIS  telephone nunber of the
 agency official  who will sign the report.

 Show the last, first  and full niddle name
 or niddle  initial of  the debtor.  Itoere
 appropriate,  indicate whether ttelitu is
 a "ST.," -Jr.,"  "II," etc.

 Show the complete nailing address for the
 debtor which has been verified by the agency
 «ithin-the past  six nonths.

 Show the agency's debtor file or reference
 ntBfeer.

 Show the anount  of  principal due on the
 fflatp*!  itfisre fees  and COBUI advanced are
 to be  recovered  fr^tn  tne debtor, include
 then in the principal.  The Certification of
 Indebtedness  which  you attach should include
 an explanation and  itenizaticn when the
 total  principal  due is a cumulative total
 and combines  separate items (e.g., recover-
 able sees  and o >stB advanced, promissory
 notes  of different  dates or amounts).
           Ttotal Interest Due:
         total Administrative
                 rOharges
 Show the  total ancmnt of .interest due

of: Indebtedness. '• Bte OKI Lif icat ion of
 Indebtedness which you attach should include
 an itenization and explanation of interest
 charges and when, for example, the total
 interest  due includes separate items such as
 interest  due en more than one promissory note
 or a aeries of discrete claims, each interest
 charge should be itemized and explained.

 Show the  total anount, through the date of
 tne  Certification of Indebtedness, of any
                                                    by the agency to cow the costs of
                                           processing and handling the claim pursuant to
                                           the Debt Collection Act of 1982, P.L. 97-365,
                                           $11(e)(2).  Ihe Certification of Indebtedness
                                           which you attach should include an itaniza-
                                           tion and explanation of such charges.

                                             -3-
FIFRA  Ckmpliance/Bof or
            A-43
Gui
1983

-------
Appendix
                                             Exhibit A-7
                Tbtal Penalty
                  Charges Due:
             Total Mount Duet
              Annual XntctMt
                         Ratet

              SOL (Statute of
            Uaitations) Dstet
                       ITEM it
   Show th* total amount, through the date of
   the Certification of Indebtedness, of any
   penalty charges which nay nave been assessed
   by the agency Ear debtor's failure to pay
   any portion of a debt more than ninety (90)
   days peat due pursuant to the Debt Collection
   M* of 1962, P.L. 97-365 $11(e)(2).  The
   Certification of Indebtedness which you
   attach should include an itamization and
   explanation of such penalty charges.
                                     it due
                                    the
Snow the total (Grand total)
en the data through the date of
Certification of Indebtedness.
                       ITEM 2:
                       ITEM 3t
   Show the rate of annual interest charged
   by the agency on the debt.

   Show the saee statute of limitations date
   which is to be entered at Item 11 of the
   COR.
THE LEtfJUK

   Show the debtor's date of birth.  In the
   case of a non-beneficiary debtor (e.g., a
   representative payee) and the date~otoirth
   of the debtor is unknown, show "unknown."
   In the event that the debtor is a corpora-
   tion or partnership, show "Not applicable
   [corporate/partnership] debtor."

   Show the debtor's social security nunber.
   In the case of a non-beneficiary and the
   debtor's social security nusber is unknown,
   show •unknown.'

   In the event that the debtor is a corpora-
   tion or a partnership, show the tax identi-
   fication nunber of the corporation. If the
   tax identification nmber of the corporate
   or partnership debtor is unknown, show
   •unknown.*

   Show any other neae(s) (alias(es)) used
   by the debtor.  If the debtor is a sole
   proprietor, show the new under which the
   sole proprietor conducts business (e.g.,
   d/b/a (doing business as) Smith's Sundries).
   If no aliases, corporate, partnership, or
   sole [itVHIL ietfckt jtiip nones are used by the
   debtor, or known, show "Not applicable"
   or •Unknown."
                                                        *_/./.

-------
Appendix                                	                                    Exhibit  A-7
                       ZXBl 4:              Show the nsne(s) the debtor used on the
                                            initial instrument (e.g., application for
                                            benefits or loan application) which gave
                                            rise to the indebtedness.
                       RBI 5:              Show the debtor's complete present residence
                                      ~ ;  -."  'address* i.e.,.:address of dwelling in which
                                            the dabtoFTTves so that he or she may be
                                            found for personal service of legal process
                                            (mrplaip* *** «M"na»«).  Do not provide a
                                            lost Office Box aJJiujs asThe residence
                                            address.  fine U.S. Postal Service will con-
                                            vert a Post Office BOB addran to a residence
                                            street address upon written request.]  It is
                                            necessary for the united States Attorney to
                                            have current residence infonation in order
                                            to aaJoe proapt and effective service of proc-

                                      •  -. •  ^ttBi-Bjsae.'of the ,oBuntylo^llBB^'*^MBa^Vl''^fBaP ^^4*A "'
                                            that verified the debtor's present telephone
                                            nuober (e.9., the document which verifies
                                            or the acLhod used 60 aeJce the verification)
                                            and the aost recent date within the last six
                                            Berths that the debtor's present telephone
                                            muter was verified.

                       RBI 9t              Show any information which will assist the
                                            united States Attorney in relocating the
                                                      he •cc-she.JBBM «fnji.
                                                         *».-•.
                                            and telephone nunbers of relatives who say

                                            wading address which the debtor left with
                                            neighbors or an eaployer, or the debtor's
                                            drivers license nusfaar.  If the
                                                     the debt to
or.  IE the agency
a ma««i'Bial credit
VTRRA  firnm-nll »nt>o flirtfn-rr*f

-------
 Appendix
                                           Exhibit  A-7
                                           bureau, include the date the debt was
                                           reported and the name, address and telephone
                                           number of the oonrnercial credit bureau to
                                           which
                                            [Stamping "Address Correction Requested'
                                            under the return address block on envelopes
                                            mailed to the debtor will alert the U.S.
                                            Metal Service to infonn the creditor
                                            agency of changes in the debtor's address.
                                            Registered Bail with forwarding and
                                            return-receipt requested is also an
                                            effective way to locate debtors.  In
                                            addition, the O.S. Postal Service retains
                                            change of address notices for one year
                                            after they have been filed by a patron.]

                                            to the case of a corporate debtor, include
                                            the current residence address of the prin-
                                            cipal officers of the corporation.  Where
                                            there is a legal successor in interest to
                                            the corporate debtor, the sane information
                                            requested in Item 5, above, and this item,
                                            should be provided for the successor party
                                            or corporation.
                                         •am CIAJM
                      ITEM lOt
Briefly describe or characterize the claim
or cause of action (e.g. , •Social Security
Administration benefitoverpaynent under
     U.S.C. S    ").
                                                                            t
                                                                 Describe in particu-
                      ira
                      ran  12:
             _
larity the nature and type of benefit ever-
payment, loan default, or other action by
the debtor which gave rise to the claim.  As
•now in the parenthetical example above, be
sure to identify the statutory, regulatory,
or other authority from which the claim
arose.  In the event the debtor has filed
a bankruptcy petition, include bankruptcy
related information in the description of
the claim or cause of action.  Attach a copy
of the initial notice to the debtor of the
benefit uam.y*yueHt loan default, etc.

Show the last date (month, day, year) on
which suit can be brought to recover the
claim or debt, i.e., toe statute of limi-
tations (SOL) data.

Show the basis for SOL (statute of limita-
tions) date, e.g., the default date, date
            ent.  As
of last payment
                                                                a general rule,  unl
FXFSA Gbapllance/Eoforceaent
            A-46
                                         If mil a 1

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Appendix
                                           Exhibit  A-7
                           13s
                      ZZB4 14:
                      1994 15:
                      IHM 16:
                           17s
 the debtor made a partial payment on the
 debt,  the  statute of limitations date would
 be based upon  the date  the agency first
 bacaea aware of the debt.  In the event
 a partial  payment was mate by the debtor,
 the statute of limitations date would be
 based  upon the date of  the debtor's last
 peyment.   (See 28 OA.C. $2415 which pro-
 vides, in  part, that ". . . every action
 for money  damages brought by the united
 State* . . . shan be barred unless the
 complaint  is filed within six years after
 the n£ht  of action accrues • * <
 in the event of later partial payment
 or written acknowledgment of debt, the
 V^flt^h  f^f ^af*^4fVl anHjiH r^a> fbaaaaaWl ^n
'again  at the time of each such payment or
                 . . .')

;vBxv ^BM^aBc*<(month, dey> '^aar) vn which
 the first  agency demand for payment was
 made on tsie debtor.

 Show the name  of the agency official,
 agent, or  office that made the first
 demand for payment on the debtor.

 Show bow the first agency demand for
 payment was conaunicated to the debtor
 (e.g., by  letter, mailgram).

 Show tha date  (month, day, year) on which
 the last agency demand  foe payment was
 made on the debtor.
                                           or office that made the last demand
                      am 18:
                      nat 19:
Show how the last agency demand for payment
was communicated to the debtor (e.g., by
letter, telephone, personal contact with
the debtor)•

Briefly explain the debtor's response, if
any, to the agency's rtaanmli for payment,
                         faer)-«< any
                         • in 4Mhich isuch
                   unicated to the agency
(e»g., by letter, telephone, personal
contact).   If the debtor did not respond
to the agency's demands for payment, stew
                                            -7-
FIFKA
            A-47
1983

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Appendix
                                          Exhibit A-7
                      TOM 30:
If the debtor denied the claim, in «*»le or
in pert, give the date (month, day, year)
of such denial and explain how the debtor's
denial of the claim was mad* known to the
agency (e.g., letter, telephone call, person-
al interview).  Briefly explain the debtor's
position with respect to the claim, if kno*n.
Explain any defenses that the debtor raised
or can be expected to raise with tespGLt bo
the claim and the Merits of such defenses.
                      ITEM 21:
                      ITEM 22:
Attach copies of any agency records docu-
menting the debtor's denial.  If the debtor
did not dispute the claim, in W»le or in
part, show "Claim not disputed by debtor."

Briefly explain any agency response to the
debtor's denial of the claim.  Attach copies
of any agency response to the debtor's
denial, in whole or in part, of the claim.
Otherwise, show 'Ha agency response."  If
the claim we* not disputed by the debtor,
show "Mat applicable."

Briefly describe any administrative remedies
and/or rights available to the debtor (e.g.,
application for waiver, request for recon-
sideration, appeal, etc.).  Explain how the
debtor was apprised of the availability of
those remedies and/or rights, and what action
was taken by the debtor with regard thereto.
9ew the date (month, day, year) of any such
application for waiver, request for recon-
sideration, or appeal.  Attach copies of any
docunents evidencing such debtor's application
for waiver, request Cor reconsideration, or
appeal.  Explain what agency action was taken
in response to the debtor's exercise of or
attempts to exercise rights to administrative
remedies.  Sou the date (month, day, year) of
any such "agency action" and attach copies of
docunents evidencing the same.  Explain any
•technical defenses" (procedural deficiencies)
that the debtor has raised or can be expected
to raise with respect to the claim and the
merits of such defenses.  (Defenses to the
merits of the claim, as distinguished from
•technical defenses,' are to be discussed
under Items 20 and 21.)

Describe and discuss the merits of any
counterclaim by the debtor against the
united States, as well as any claim for
offset whish the debtor may assert.
                                             -8-
FIFEA Gmpliance/Enforcesjent
            A-48
Guidance _ffaniu» 1

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Appendix                            	  	Exhibit A-7
                      XXEM 23:             Show the amount and date (month, day, year)
                                           of any oomprcmise offer made by the agency
                                           or elicited from the debtor.

                      HEM 24<         ,   Briefly explain whether the compromise offer
                                         ;  .was  elicited from the debtor or offered to
                                           the  debtor by the agency.  Explain the basis
                                           of or reason for the amount of the compro-
                                           mise offer, if known.

                           25s             Show the agency or debtor's response (speci-
                                           fy which} to the aaiptuniiee offer and the
                                           reason for the acceptance or rejection of
                                           the  offer in compromise (e.g., "the debtor
                                           asserted that he had no funds with which to
                                           pay  the compromise offered by the agency*


                                          ' discretionary expenditures are 10 times the
                      RBI 26*              Show the named) and present residence
                                           address(es) of any other peraon(s) liable
                                           for repayment of the debt (e.g., benefici-
                                           corporate officers)•  Jhe present residence
                                           aJJieat provided should be that of the
                                           dwelling in which the person lives so that
                                           he or she may be personally served with
                                           legal process (camplaint"anS swoons).  If
                                           .no other person is legally responsible for
                                           the debt, show "tone.*
                          27s
                                              other pertiee. •ftcDl«ini
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Appendix
                                          Exhibit A-7
                                            how the claia arose  (including the statutory,
                                            regulatory,  or other authority from which the
                                            claia arose, a sunaary statement or resume
                                            of tbe factual basis for the claim, an itsni-
                                            sation of the dates  and amounts of any pay-
                                            ments aade by the debtor to tbe agency or any
                                            credits aade by  tbe  agency to the debtor, and
                                            an itemization of the  anoint due and owing)
                                            and should be fix the  fr" amount of the debt
                                            show) on the first page of the report.  Attach
                                            tbe Certificate  of Indebtedness to the report.
                                            Zn the event that the  debtor bee filed a
                                            bankruptcy petition  and if tbe nature of the
                                            security agreement and the property In which
                                            tbe Ohited States has  a security interest is
                                            each that tbe debtor can reaffirm the debt,
                                            then list the number,  dates and amounts of
                                                   t to  which the  debtor is in
                           29s
                              Iw. fel.
                              ay cn
Although there nay be aany exceptions,  this
anoint will usually be the principal anoint
of tbe indebtedness before the accrual  of
interest and be Cure the debtor has aade any
payments.
                      net 30:
9>ow the *•**•! Hir*TT  and anoint of any
payeents made by the debtor to the agency
or tbe agency's assignor, or any credits
made by the agency to the debtor,  foe
example, if 5 payments of $25.00 each,  enow
•5 psy*ants/$125*; if 2 credits of $30.00
each, show -2 credits/560.'  indicate the
nature of such paynenta or credits,  i.e.,
whether they were, for exanple, by dHset,
lunp sun or installaent.  If no pavaents or
credits ware aade, show "None.'
                           31t
                           32:
                           33:
Zf peyacnts or credits were Bade,  sikjw the
anoint which was applied to the principal of
the debt.  Otherwise,  show "Mot applicable."

Show the total anoint which MS applied to
any administrative charges asamsed by the
agency, any penalty chargee •	' by the
agency, and the interest due on the principal
anoint of tbe debt, if applicable.  Zf not,
show "Not applicable."

Show tbe remaining balance due  on the prin-
cipal anouiL of the debt.  Zn the event that
the debtor has filed a bankruptcy petition,
show the balance due on tbe principal as of
tbe date tbe petition  tea filed.
                                            -10-
FIFRA Ompliance/Enforceaent
           A-50
Guidance  Manual 1983.

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Appendix                       	Exhibit  A-7
                     TTEK 34:              Show the balance due on any administrative
                                           charges assessed by the agency, any penalty
                                           charges aanesiwil by the agency, and the
                                           accrued interest en the principal anoint  of
                                           the  debt, if applicable.  If not, snow "Mat
                                           applicable.*  m the event that the debtor has
                                      :\    filed a bankruptcy petition, show the interest
                                           doe  Co the date the petition was filed and
                                           daily »"•'•"»* of interest Uif'••^*M'-
                      ZXEN 35s              Bcplain how piysants received from the
                                           are to be applied.  Rnally, tfcen a debt
                                           is paid in partial or instaUnent peywnts,
                                           aaouits received by the agency should be
                                           applied first to any outstanding administra-
                                           tive onsBges which have been assessed by the
                                           agency pursuant to the Debt Collection Act of
                                         -  1962,-P.U 97-365, lll(eH2Jr second, to any
                                                   by the agency tor debtor's failure to
                                           pay any portion of a debt sere than ninety (90)
                                           days past **» pursuant to the Debt Collection
                                           Act of 1982, P.L. 97-365, 511(e)(2)> third, to

                                           principal.            •
                     RBI 36:              Show the  laanrit and date (spnth, day,  year)
                                           of  the last psjsMnt which the debtor svde
                                           to  the agency or the agency's assignor.

                     RBI 37*              Show the  interest computation or interest
                                           accrual date (i.e., the date from which
                                           interest  is dueT7~if applicable.  If not,
                                           stow "Not applicable."
                      RBI 38:              Snow the naee, cpopieta address and telephone
                                           nuBtaer of the debtor's present eaployer.   If
                                           the  debtor's actual place of work is different
                                           fraa the espiLoyer's address and is know,
                                           provide the eddieee and telephone nueber of
                                           the  debtor's vork place.  This infatuation
                                           «U1 assist tfae Dnited States Attorney in
                                           asking i»in%<  service of p * i •»• .upon the
                                                                              or'her
                      XXBl 39:              Show the date (Berth, day, year) the debtor's
                                           enployBant was verified by the agency within
                                           the  past sin sonths, and the *WIPP* of that
                                           verification (e^., the debtor, debtor's
                                           -11-
FIFRA Govpllance/OiforcesKnt                 A-51            Guidance Manual 1983

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 Appendix	   Exhibit A-7
                      ZIBt 40:              Show the debtor's weekly or monthly salary
                                            and indicate whether the amount shown is
                                            gross or net salary.  For example,  ahow
                                            •$350/weekly/gross.•

                      REN 41 j              Show tne date (month, day, year) the salary
                                            was verified by the  agency within the past
                                            six months, and the  source of that  verifi-
                                            cation (e.0^, the debtor, debtor's  employer,
                                            current documentation).

                      HEN 42:              If applicable and known,  show the name,
                                            address and telephone rof1"'1^' of the
                                            spouse's employer.  If none of the
                                            information is available, ahow "Nat
                                            available.'

                      REN 43:              If applicable, ahow  the  date (month, day,
                                            year) the spouse's employment was verified
                                            by the agency within the past six months,
                                            and the source of that verification (e.g.,
                                            spouse's employer, current documentation).
                                            If none of the information is available,
                                            show "Mot available."
                                   DEBIOt'S ABttRY 10 VKt

                           44:              Explain the evidence that discloses and the
                                            basis for the agency's deteonination that,
                                            given the debtor's present or likely future
                                            avaiiaEITity at assets or income, a sub-
                                            stantial sum may be obtained by enforced
                                            collection proceedings against the debtor.
                                            in* agency's determination should take into
                                            account any exemptions to which the debtor
                                            is entitled under state and Federal law,
                                            the debtor's age and health, the debtor's
                                            education, present and potential income,
                                            number of dependents, inheritance prospects,
                                            and the possibility that assets have been
                                            concealed or improperly transferred.  Also,
                                            provide information concerning any legal
                                            proceedings,  such as proceedings in bank-
                                            ruptcy, that may affect the government's
                                            ability to collect the debt.  Attach to
                                            the report all supporting documentation
                                            including,  for example, a current credit
                                            tepuit or financial statement.  In the
                                            event of a eaporatje debtor, an audited
                                            balance sheet of the corporate
                                            be attached.
                                            -12-
FIFRA Grapllance/EoforceBent                 A-52            Guidance  Manual 1983

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Appendix
                                           Exhibit A-7
                                           (tote:  A realistic determination of a
                                           debtor's financial ability to pay is essen-
                                           tial to enforced collection, particularly
                                           with regard to small, unsecured claims.
                                           ine financial evidence which is provided to
                                           the united States Attorney oust be current
                                           tfJQ iflssVsVJBufftaB *tPQi sVUVt QiSdO8B tftsSt tn1^
                                           debtor has sufficient incomt to pay the
                                           debt, or unencuBbered non^exenpt assets,
                                           real or personal, which can be used to
                                           liquidate the debt.  Generally, if there
                                           is insufficient incase or unencumbered
                                                  to meet the debtor s
                                           •necessaries" (i.e., indispensable things,
                                           or things proper and useful, oar day-to-day
                                           living, sucb as food, clothing, medical
                                           attention, and a suitable place of resi-
                                               »), the^date should not be Deferred to
                                                                       or litigation
                                           and enforced collection.  A good rule of
                                           tbuab tor determining whether there is a
                                           rsesnnshle |s.>jspeut for c.forced collection
                                           of a substantial SUB on a •••ail, unsecurea"
                                           cZJum is tnet sucna claim should not be
                                           referred unless the evidence provided
                                           diwcloees that tfae^debter has sufficient
                                                  to pay for 'necessaries* and at
                                                 $1800 over a 3-year period7"or that
                      HEM 45:
       or property which is at least 10
times greater in value than the amount of
the obligation.

Provide any Information which will assist
                              ^m»l [|[j £SSl
                     in *ieh the 'Ghited
States has or may have a security 'nterest.
Describe and give the last Jmown location
of such property.  Describe *nd attach
security agreements or real estate or
chattel sortganes which give the United
States a security interest (e.q., papers in
the agency's file which describe or show
what ptm«ety was pledged).  Show the asset
cr fair market value of any such real or
JJSITsuual jjBaisu. ty 4or •
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 Appendix
                                                                  Exhibit A-7
                      ITEM 46:
                      XTBt 47:
                       Provide any information tnich  will  assist
                       the Qhited States  Attorney  in  locating
                       other assets of the debtor  (i.e., assets
                       other than pledged pixipetLy snowh in Item
                       45).  Particular care should be given to
                       identifying Hjn-eaemjt assets  of the debtor
                       (e.g., real estate which is not the hone-
                             of the debtor, a second  vehicle,
                            •tional vessels, etc.).  In the
                             of a corporate debtor, provide any
                       information which  will assist  the united
                       States Attorney in locating other assets
                       of the corporation.  If this information
                       is unknown, show "Unknown."
                  VAIJ3E Of CLAIM

                       Show and explain the  fair csrket or asset
                       value of the claim, i.e., the amount of
                       cash which may be realized  as a result
                       of litigation of the  claiau  Bcplain the
                    •   basis tor the value given.  The agency's
                       determination of the  value of the claim
                       should be based in part upon the ratio
                       which the amount of the claim or debt bears
                       to the aeount of the  debtor's assets and
                       income which can be realized by enforced
                       collection and upon the unencusbered value
                       (after prior liens have been satisfied)
                       of any property of the debtor in tciicb
                       the United States has a seemed interest.
                       The information provided should reflect
                       the true value of the claim and, thus,
                       enable~a»e United States Attorney to sore
                       accurately determine  the amount which the
                       government is likely  to recover by enforced
                       collection.  See the  rule of thunb in the
                       Note at Item 44,  above, for determining
                       whether there is a reasonable prospect for
                          48t
                       enforced  collection of a. substantial sum.

                       With due  regard to the debtor's ability to
                       pay as definedby Item 44, above, show the

                       which  the claim can reasonably be settled

                       the aeount shown.  This aeount should bear
                       a direct  relationship to the debtor's

                       by  garnishment, levy, or attachment.  The
                       agency's  iei.i'mmii»1srln» will provide the
                       United states Attorney with the
                                           -14-
FIFKA Gnaplii
i/Eofor
A-54
Guidance Manual  1983

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Appendix                       	Exhibit A-7
                                           intonation and guidance for an informed
                                           consideration of any compromise offer or
                                           settlement the debtor may mate.  Further-
                                           more, having such information beforehand
                                           will eliminate the delay and expense which
                                           wuld otherwise be necessary for the united
                                           States.Attorney to obtain the agency's
                                           assessment of a debtor's "ry'^** offer
                                           made after the claim has been referred  to
                                           the united States Attorney.
                            TRANSFER OR lliHHrr CEFQSIT Of FCND6

                      IBM 49t              Show the name, title,  complete mailing
                                           address and PIS telephone HIST^T of  the
                                           agency official at the accounting code