Federal Insecticide, Fungicide,
and Rodenticide Act
COMPLIANCE/ENFORCEMENT
GUIDANCE MANUAL
US. 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 Rodenticlde 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 Ixxteragency 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
p] VfIA
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Chapter Five; Determination of Appropriate Enforcement Response
Introduction
Level of Action Policy
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 Nlne^; 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
Ten; Post-Settlement Enforcement
Monitoring Settlement Agreements
Enforcement of Settlement Agreements
Chapter Eleven; Special Considerations
TXZ&A Section 7 Confidential Information
Disclosure of Confidential Information
K"*r>T'rrf>fnf 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
FIFRA CoKpllance/Enforceaent Guidance MMIU.I 1933
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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 Rodenticide 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
^pJpyS" Cn*p'H*nr»/Vnft\-rr>o^*ntt 1-i QrH ^ano* ManmT
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4c 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
V-ll t^rtfimp^ Tlinilll I1fl*
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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* Oridaac* Manual (T«ar)
FIFRA uompiianre/enrorcement 1-1 Guidance runuuii
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Chapter One Overview
When revisions entail the addition of pages into the manual (i.e., when
three pages in the nanual 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
JJEA — 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
RUP — Restricted Dae Pesticide
SSDRO — Stop Sale, Use, or Removal Order
U.S.C* — United States Code
l—2 Guidance namrr^ J.983
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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, shipping, 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;fey
the Administrator where appropriate to ensure protection of the environ—
ment. Under the Act, all producers of pesticides and pesticidal
are required to register their establishments with the Administrator•!
FIFRA Case Proceedings Manual 1-3 f^i^r"^ 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 inflects, 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
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 FIFBA. 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.
Synopsis of the Act _
FIFRA authorizes the registration of pesticides as well 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
jQS £ or /restricted '.aue pesticides; issuance iff- yirpyriy^tgl use
permits? : and promulgation of pesticide application vtsndards . 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.
corcement 1-4
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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 veil 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 Pse 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 veil 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.
Administrative 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 pyi^r*** Manual 1983
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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 toe
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 well 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)
7HSA authorizes, upon presentation of ^proper Credentisl« 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 samples of any pesticides or devices that are packaged, labeled,
and released for shipment and samples of any such containers and labeling.
Jf .n^MMr-j-j m*mr***n*~ ^*y*• «iif»«-y|ii»a :*«•«• ,-m «H«tr1ft COttTt tO gain CntTJ,
Jastpscct* 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.
1-6
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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 nay 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)
f
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
FIFKA. Ooapll«ncr/Bnforcement 1-7
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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 Review (Section 16)
District courts are given authority to reviev 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 Administrator «111 «dvlae «nd a*8lst the Department of
3*VB»port*tian In matters relating to .the 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.
XFIA Ckmpliance/BaforceMent1-8 Qajdgn^ lumnal 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 may 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.
Eorcement 1-9 Qnidf""* "••"••» 199?
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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.
StatePrimary 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.
Failureby the State ToAssure Enforcement of State Pesticide Use
Regulations (Section 27)
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
jpTfMI -H"*g *o respond, the Administrator IB authorized to take .Immediate
action.
Identification of Pests ; Cooperation with Department of Agriculture ' s
Program ( Sec t ion JZ81
The Administrator, in coordination with the Secretary of Agriculture, is to
identify those pests that must be controlled* In addition, the
and Implementation programs in order to determine the safest and most
effective pesticides or control methods available.
Bcport (Section 29)
An f"*!"^1 xeport jBust be submitted
Jtebxamry 'lifrjqf ^i»«cfr-!f!»«g».-:i;t»ttng -•U.'-.-^e- applications --for conditional
oomp 11 anc«*/ Boiorcement 1-1U GnlflsTir* ifcir1*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.
FIFBA Compliance/fiaforce«ent 1-11 Guidance »%«nf*l 1983
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Chapter One Overview of the Act
ump-LUrnce/Ea±orce»ent FT2 Gnldmi— M-^...I
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Chapter One
3 Federal Insecticide, Fungicide, and
Rodenticide Act (As Amended)
La. 92-SU,
i Uw 94.51. Mtk
Patafe Lav 94.lt*. Mth
i Uw M-14*. Mth C
: Lav 95-231, Mtk C
UwMOM. 93tt
HJt. 1079, Oriaaaf 21, 1972
by
HJL 43T7, My X 1915;
S. J37S. Ouilir 10, 1973;
HJL IS41, .Nina** ». 1975;
HJt 6979. Man* 27, 1978:
S. I67S. Sijiiaifcaf M. 1978:
9M39, ttta Coa*ns*. Dmatar 17. IMO)
flit flrt
Ktdml
f-nvironmmial
Pmicnit
Control Ao
o( I9U.
61 Sin. 163:
nSin. ISO.
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 I. 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. Short tide and table of comems.
"(a) Short lillt.
"(b) Table of contents.
"Sec. 2. Definitions.
"(a) Active ingredient.
"(b) Administrator.
"(c) Adulterated.
"(d) Animal.
"(e) Cert i Tied applicator, etc.
"(1) 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.
"0) Environment.
"(k) Fungus.
"(I) Imminent hazard.
"(m) Inert inirediem.
"(n) Ingredient statement.
"(o) Insect.
"(p) Label and labeling.
"(I) Label.
"(2) Labeling.
P.I.. «-»(.;
"(q)
"(r)
"(D
"(t)
"(u)
"(v)
"(w)
"<*)
ment.
"(y)
"W
Misbranded.
Nematode.
Person.
Pest.
Pesticide.
Plant regulator.
Producer and produce.
Protect health and the environ-
Regtiirant.
Registration.
"(aa) State.
"(bb) Unreasonable advene 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. ' .
PIPftA Cempiiance/Eafor
1581
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Chapter One
"(3) Time for acting with respect "Sec. II. Standards applicable to pesticide ap-
10 application. pltcaiors.
"(4) Notice of application. "(a) In general.
"(5) Approval of registration. ••({>) Separate standards.
"(6) Denial of registration. ••$«. 12. UnUwful acts.
"(7) Registration under special cir- "(aj |n general.
cumstancn. • • "(b) Exemptions.
"(8) Interim administrative review . ••$«:. 13. Slop sak. me. removal, and seiture.
"(d) Classification of pesticides. "(a) Slop sak, etc.. orders.
"(I) Classincation for general use, "(b) Seizure.
restricted use. or both. "(c) Disposition after condemnation.
"(2) Change in classification. "(d) Court costs, etc.
"(3) Change in classification from "Sec. 14. Penalties.
restricted use to general use. "(a) Civil penalties.
"(e) Products with same formulation "(I) In general.
and claims. "(2) Private applicator.
"(0 Miscellaneous. "(3) Hearing.
"(I) Effect of change of labeling "<4) Determination of penalty.
or formulation. "(3) References to Attorney
"(2) Registration not a defense. General.
"(3) Authority to consult other "(b) Criminal penalties.
Federal agencies. "(I) In general.
"U> Reregistration of pesticides. , ' "(2) Private applicator.
"Sec. 4. Use of restricted use pesticides; certified "(3) Disclosure of information.
applicators. "(4) Acts of officers, agents, etc.
"(a) Certification procedure. ' "Sec. IS. Indemnities.
"(I) Federal certification. "(a) Requirement.
"(2) State certification. • "(b) Amount of payment.
"(b) State plans. "(I) In general.
."(c) Instruction in integrated pest "(2) Special rule.
• management techniques. "Scv. ,M. :Adminismtive procedure; judicial
"Sec. S. -Experimental use permits. review .
"(a) Issuance. "(a) District court review.
"(b) Temporary tolerance level. "(b) Review by Court of Appeals.
"(c) Use under permit. "(c) Jurisdiction of district courts.
"(d) Studies. "(d) Notice of judgments.
"(e) Revocation: "Scv. 17. Imports and exports.
"(f) Stale issuance of permits. "(a) Pesticides and devices intended for
"(g) Exemption for agricultural research export.
agencies. "(b) Cancellation notices furnished to
"Sec. 6. Administrative review; suspension... foreign governments.
"(a) Cancellation after five years. "(c) Importation of pesticides and de>
"(I) Procedure.' vices.
"(2) Information. "(d) Cooperation in international
"(b) Cancellation and change in classifi- efforts.
cation. "(c) Regulations.
"(c) Suspension. "Stx. |g. Exemption of Federal agencies.
"(I) Order. . "Set. 19. Disposal and transportation.
"(2) Expedite hearing. "(a) Procedures.
"(3) Emergency order. "(n) Advkxio Secretary of Transpona-
"(4) Judicial review. linn.
"**td) •Public "heai ings and scientific re- "to 'Provisions Tor unused quantities.
VICW- _ . ..... "Sec. 20. Research and monitoring.
"(e) Conditional registration. , ••(,) Rc-earch
"(0 Judicial review < ..(b) Naiionarmoniioring plan.
7. Registration of establishments. ..jc)' Monitoring
1 of eoininenls: B0"ce of
«/|j) Cooperation
V S
"tal
.
;**«r««ionwid education.
. "Sec. J4.A«thority of Slates.
. _..}b>- J^SSLas ' ' °See' *• ****** °r Admtoiitraior.
K) I'.nitKCcnicni. **im\ tt\ •••iLiaiin.i.
••(DCertificaiionofractsioAi-
. _______
nvncy
(3i warning notices. *Hcl Oil^ ••thr»1i»
"Sec. 10. Prmection of trade secrets and other «jflj ScfcrtificiSrliory panel
in general.
umpii mace/ aarorce»ent 1-14 Qqld«"<*» H>ira*l 1983
-------
Chapter One FTTRA
"SEC. 2. DEFINITIONS.
"For purposes of this Aci—
"(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 (he 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 (he Administrator
of (he 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.—
"(1) Certified applicator.—The term 'certified applicator' means any
individual who is certified under section 4 as authorized to use or super- 7 use I
vise the use of any pesticide which is classified for restricted use. Any PL
applicator who holds or applies registered pesticides, or use dilutions of n *•'• "9
registered pesticides consistent with section 2(ee) of this Act. only to
provide a service of controlling pests without delivering any unapplied
pesticide to any person so served is not deemed to be a seller or
distributor of pesticides under this Act.
"(2) Private applicator.—The term 'private applicator' means a cer-
tified applicator who uses or supervises the use of any pesticide which is
classified for restricted use for purposes of producing any agricultural
commodity on property owned or rented by him or his employer or (if
applied without compensation other than trading of personal services
between producers1 of agricultural commodities) on the property of
another person.
"(3) Commercial applicator.—The term 'commercial applicator'
means an applicator (whether or not he is private applicator with respect
to some uses) who uses or supervises the use of any pesticide which is
classified for restricted use for any purpose or on any property other
than as provided by paragraph (2).
"(4) Under the direct supervision of 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 ap-
plied by a competent person acting under the instructions and control of
a certified applicator who is available if and when needed, even though
such certified applicator is not physically present at the time and place
the pesticide is applied.
"(f) Defoliant.—The term 'defoliant' means any substance or mixture of
substances intended for causing the leaves or foliage to drop from a plant,
with or without causing abscission.
"(l) Desiccant.—The term 'desiccant' means any substance or mixture of
substances intended for artificially accelerating the drying of plant tissue.
"(h) Device.— The term 'device* means any instrument or contrivance
(other than a firearm) which is intended lor trapping, destroying, repelling, or
mitigating any pest or any other form of plant or animal life (other than man
and other than bacteria, virus, or other microorganism on or in living man or
other living animals); but not including equipment used for the application of
pesticides when sold separately therefrom.
"(i) District Court.—The term 'district court' means a United States
district court, (he District Court of Guam, the District Court of the Virgin
Islands, and the highest court of American Samoa.
"0) Environment.—The term 'environment' includes water, air, land, and
all plants and man and other animals living therein, and the interrelationships
which exist among these.
Coapllance/Enlorceaent PT3
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Chapter One
FIFRA
st IV*
"(k) Fungus.— The term 'fungus' means any non-chlorophyll-bearing
thallophyle (thai is. any non-chlorophyll-bearing plant of a lower order than
mosses and liverworts), as for example, rust, smut, mildew, mold, yeast, and
bacteria, except (hose 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.
"(m) Inert Ingredient.— The term "inert ingredient' means an ingredient
which is not active.
"(n) Ingredient Statement. — The term 'ingredient statement' means a state-
ment which, contains —
"(I) 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 *nd 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
States 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 Held of
pesticides.
"(q) Misbranded.—
"( J) A pesticide is misbranded if —
"{A) its iabeJing bears any.souement. design, -or graphic represen-
tation relative thereto or to its ingredients which is false or
misleading in any particular;
"(B) it is contained in a package or other container or wrapping
which does not conform to the standards established by the Ad-
minisuator pursuant to section 2S(cX3);
"(C) ii is an imitation of, or is offered for sale under the name of,
another pesticide;
"(D) its label does not bear the registration number assigned
under section 7 to each establishment in which it was produced;
"(E) any word, statement, or other information required by or
iroder authority of tins 'Act to appear >t>n the iatae) or tabenng is not
(as compared
i use i3«i.
i use i3«i.
P.L. t5-JW: 92 Slit. 119:
TUSC IM>.
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-
quirements imposed under section 34d) of this Act. are adequate to
protect health and the .environment;
» • *^(C)*be^pel jtoes«ot co«aaia-«'*»raim or -caution statement
- which -nwy-be necessary and if compiled willi, together with any re-
quirements imposed under section 3
-------
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 or purchase and use, (he
following: 'Not Registered for Use in the United Slates of America'.
"(2) A pesticide is misbranded if—
"(A) the label does not bear an ingredient statement on that 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 subparagraph 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 pan 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 ctossbones;
"(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)
in case of poisoning by the pesticide.
"(r) Nematode.—The term 'nematode' means invertebrate animals of the
phylum nemathelminthes and class nematoda, 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(cKI).
"(u) Pesticide.—The term 'pesticide'means (I) any substance or mixture of
substances intended for preventing, destroying, repelling, or mitigating any
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 • new animal drug by • regulation establishing conditions of
use for the article, or (2) that b an animal feed within the meaning of section
20l(x) of such Act (21 U.S.C.32l(x)) bearing or containing an article covered
by clause (I) of this proviso."
"(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 incculants. and soil amendments. Abo, the term 'plant
TU5CH*.
r.L. •*.!«•.
«* Sui. »«.
F1FKA CoBpLLance/Enf orceiKnt
"PIT
T585
-------
Chapter One
FIFRA
P.L. »5-3«»:
*}&!•. IIS.
P.L. »•»»;
« Sui. ll«.
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.—The term 'producer' means the person who
manufactures, prepares, compounds, propagates, or processes any pesticide or
device or active ingredient used in producing a pesticide. The 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) State.—The term 'State* means a State, the District of Columbia, the
Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Trust Territory
of the Pacific Islands, and American Samoa.
"(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) Wted.—The Jenn 'weed' means may. plant which .grows where not
-wanted.
"(dd) Establishment.—The term 'establishment' means any place where a
pesticide or device or active ingredient used in producing a pesticide is
produced, or held, for distribution or sale.
"(ee) To Use Any Registered Pesticide in a Manner Inconsistent With Its
Labeling.—The term 'to use.any registered pestiscide 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 (1) 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 inethod of applirationnrt prohibit or (4)
• :Bmiiig a.pesttadc or pejtiodes with a fertuuer-when surh jsmture is not pro-
tebited fry the labeling: 'Pi wided further. That the term also shall not include
7 use IMC. iuo. iJ*. any we of a pesticide inconfonnance with section 5.18, 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 • dilution less than label dosage unless before or after that
date the Administrator issues a regulation or advisory opinion consistent with
i use IM..4 «, UK arty provided for in section 27(b) of the Federal Pesticide Act of 1978,
wfakta regulation or advisory opinion spedfkaDy requires the use of definite
lints of dilution.
"(a) Requirement.—Except as otherwise provided by thb Act. no person in
any State may distribute, sell, offer for sale, hold for sale, ship, ddter for
shipment, or receive and (having so received) delivery or offer to deliver, to
any person any pesticide which b not registered with the Administrator.
"(b) Exempiioas.—A pesticide which b not registered with the Ad-
ministrator may be transferred if—
"(I) the transfer b from one registered estaMbhment to another
registered establishment operated by the same .producer soldy for
"(2) the transfer b pursuant to and in accordance with the re-
quirements of an experimental use permit.
"(c) Procedure for Registration.-
(1) Statement required.—Each applicant for registration of a
pesticide shall file with the Administrator a statement which includes—
snt
i-io
Goaaaaee Manual 1983
-------
"(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 thai pertains solely to such
ne* 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 (DKO 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 made 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-'
lion and Conciliation Service to appoint an arbitrator from the j
roster of arbitrators maintained by such Service. The procedure j
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 coun 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
parties 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
f
P.L. »5-J»6.
9JSi«i. 120.
(Set nac
-------
Chapter One
FIFRA
P.L. 95-)«6:
«Snr 124.
7 USC IJM.
P.L.
«2 SMI 122.
Nmirmion.
AftMrwiun.
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;
"(ui) after expiration of any period of exclusive use and any
period for which compensatioa is required for the use of an item
of data under subparagraphs (DXO and (DXH) of this paragraph,
the Administrator may consider such hem 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 p/trgaiiaiioa.—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
such additional 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
^section JO, within JOvdays after the Administrator registers a
pesticide under this Act be shall juke available to the public the
data called for in the registration statement together with such other
scientific information as he deems relevant to his decision.
"(B) Additional data to support existing registrations.—
"(j) If the Administrator determines that additional data arc
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
icnoo.
•fji) Each registrant of such pesticide shaO provide evidence
pest*
within ninety days after receipt of notification that it b taking ap-
.propriale »ttp» to jeoire-taea^^ .
Twoormoreitgniianii is»j agm io develop jointly, or to share
m the «ostoT 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 such registration.
"(ui) 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 development anaogeroent or on a pro-
', iceduie for teaching such agreement, any trf such registrants nay
•Jniliate binding arbui«Uun proceedings by ^requesting 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
FIFRA
OoAAt
1553
-------
inapter Ope
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 bearing is nude 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 this subparagraph, the Administrator shall by regula-
tion, prescribe simpjified procedures for the registration of
pesticides, which 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
"(ii) offer to pay reasonable compensation otherwise required
by paragraph (1XD) 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 expeditiously 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 (I) and (2), a notice of each application
for registration of any pesticide if it contains any new active ingredient
Payment of
arbitrator.
Hcarin|.
T USC IMd.
P.L. »J-J»6;
n Sial. U4.
P.L. t»-»»:
n Sui. ««.
Federal ftefiutr.
FIFRA CbapllaD.ee/EnforceBent~
1-21
Guidance Manual 1983
-------
Chapter One
PIFBA
f.L.
n SMI. MS.
7 USC I3*».
PuMieaimn in
Federal fttfbiCT.
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.
"4fi)'Dtnial of reguifalion.—lf .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 nave the same remedies as provided for in section 6.
"(1) Registration under special circumstances.—Notwithstanding the
provisions of subsection (cM5) of this section—
"{A) The Administrator may conditionally register or amend the
..legislation ota'pesticideif .the Administrator determines thai (i) the
prsiiridr 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
advene 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
ucd, ibe Admijiisiratof may >njist£r.,or:amend the registration
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 • pesticide to permit additional uses of soch pesticide notwith-
standing that data concerning the pesticide nay 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
Pioppstd fry-ttcijnplimii *DiiM «ot ^jgniTicanth/ av
vene effect «n*the*cnviron-
ment. Notwithstanding the foregoing provisions of this subpara-
graph, no registration of a pesticide may be amended to'permit an
additional use of such pesticide if the Administrator has issued a
notice stating that such pesticide, or any ingredient thereof, meets or
exceeds risk criteria associated in whole or in part with human
6Mpiianee/Bnforce»Bat
UTO
-------
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 shaJI submit such data as would be required to obtain
registration of a similar pesticide under subsection (c)(S) 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 thai 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-far 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 recognized
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. «-J96.
92 Sill. «2ft.
Notice of
Definition*.
Publiniion in
Fcdtrtl Rcthin.
P.L. 9J-W6:
« Sin. U6.
fir HA. umpxiance/cazorceaeat
Guidance Manual 1983
-------
Chapter One FIFE*
injury to.the applicator, he shall classify the pesticide, or the par-
ticular use or uses to which the determination applies, for 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
reviewable 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.
puhu-.iii.Hi .r "(2) Change in classification.—If the Administrator determines that
i cj.-...i K.-,.-K-, a change jn 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
7ii« i.«*d; registrant, may seek relief from such determination under section 6(b).
PI «xw». "(3) Cftaitge tn classification frvmitMikted use 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 iMn. 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 nitration by
'supplemental •statements.
"
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Chapter One
FIFRA
"SEC. 4. USE OF RESTRICTED USE PESTICIDES; CERTIFIED AP-
PLICATORS.
"(a) Certification Procedure.—
"(I) Federal certification.—In any State for which a State plan for
applicator certification has not been approved by the Administrator, the
Administrator, in consultation with the Governor of such State, shall
conduct a program 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 (aX2) 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 State 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) State certification.—It 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—
"(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 fives 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'M.
P.I
v: s
Public hearing).
Sundirdi
P.L. **•!«>:
W SKI. 733.
PIPRA Coapliance/Enforce»ent
-------
inapter One
FIFRA
not taken within a reasonable lime, noi to exceed nineiy days, the Ad-
ministrator shall withdraw approval of such plan.
P.I. sM.nn. "(c) Instruction in Integrated Pest Management Techniques.—Standards
14 sni. ?M 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
^ usc ij*u 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 Slates im-
plementing such plans shall provide that all interested individuals are notified
of the availability of such instructional materials."
7 USC Utc
P.L. W-3W:
w »•!. ta.
7 USC IM>.
»USC I
7 USC 1Mb.
P.L.
. 754.
"SEC. 5. EXPERIMENTAL USE PERMITS.
. "(a) Issuance."^Any 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 liter 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 experimental,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) Revocation.—The Administrator -may revoke any experimental use
permit, at any time, if he finds that its terms or conditions are being violated,
or that tommy 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.
"(() Exemption for Agricultural Research Agencies.—Notwithstanding the
foregoing provisions of this section, (be Administrator may issue an ex-
perimental use permit for a pesticide to any public wjiriinte agricultural
ireaearcnaigncy»edniai»OBalmstitu^
jpennitdiBaU4>ot weed more than a oue-ycai period or such other specific time
as the Administrator may prescribe. Such permit shall be issued under such
terms_and conditions restricting the use of the pesticide as the Administrator
may'require: Provided. That such pesticide may be used only by such research
agency or educational institution for purposes of experimentation."
7 ws<- IJM "SEC. 6. ADMINISTRATIVE REVIEW; SUSPENSION.
"(a) Cancellation AJter Five Yean.—
r—The Administrator abaD
of
ratine end otthe five-year period which begins on the date
of its registration (or at the end of any five-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
? floxur cewiut
Guidance Manual 1984
-------
Chapter One
FIFRA
regulations prescribed by the 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
shall 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 nocice) 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 analysis 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 (I), whichever occurs later, unless within (hat time either (i) the
registrant makes the necessary corrections, if possible, or (ii) 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, the 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 indude
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 the agricultural economy, and he shall publish in the 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
l Refiner.
Hrarinr
P.L. 94-140;
WStal 151
Publication in
. t-'nirral RrttMn.
nsut. ta.
P.L. *4-l40:
19 Sid. 751.
Ooapliance/Enforceaent
tjuidance Manual 1983
-------
Chapter One
FIFRA
(OSui. )«l:
II SKI. M.
J USC Ml.
7 USC IJtn.
»usc*pp.
Report.
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 bearing 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
vestaWished t»y.*aw_ Tire effect oTany order of the «ourt 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
slated by ;lhe;Adnmistraior,if iS'iicctsgry •oT^dBtrable, ititc Hcanng £x*
^•nimB^faaUi«t
-------
Chapter One
FURA
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(cX7) 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. 95-396;
92 Slat. 828.
Notice.
7 USC IJ6a
^ USC I36n.
"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.
1USC IJ4.
P.L. 95-394;
92 SIM. 829.
«29.
FIFRA Compliance/Enforcement
Guidance Manual 1983
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Chapter One
PIFEA
"(d) Confidential Records and Information.—Any information submitted
« sin. IN 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
7 use iw> subject to the provisions of section 10.
7 USC 134*
RtfuUttom.
P.L. 95-396:
92 Sin. IZ9.
"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 Tiled).
"(b) Inspection.—For (he 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 Slate 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.deyice. Any inspection with respect to any
records and information referred to in this subsection shall not extend to
financial dala, sales dala 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 Tiled).
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 the inspection, including a statement as to whether a violation of the law is
suspected. If no violation is suspected, an alternate and sufficient reason shall
be given in writing. Each such inspection shall be commenced and completed
with reasonable promptness.
1 USC I3*c
"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-
prapriate credentials and a written statement 'as toJhe.rcsson for theinspec-
Jroyinrlndmgastatemem as to whether* vto 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
xpon.a snowtngtoxn officer or court of competent jurisdiction that there is
reason to Wiev* that the Pfovhiomoftrns Act 4»avej>ecii violated, officers or
employees duly designated by the Administrator are empowered to obtain and
to execute warrants authorizing—
"(I) 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
Compliance/finrorcement
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Chapter One
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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 it 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 this Act have
been violated by such person, then the Administrator shall certify the
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
14(a), when the Administrator determines that such action will be suffi-
cient to 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 the 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 (1) 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 the 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 the 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 to protection under subsection (b).
"(d) Limitations.—
"(I) 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 effects of such pesticide on any organism or the behavior of such
pesticide in the environment, including, but not limited to, data on safe-
ty lo fish and wildlife, humans and other mammals, plants, animals,
and soil, and studies on persistence, translocation and fate in the en-
vironment, and metabolism, shall be available for disclosure to 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—
1 USC 1Mb
P.L. 95-396;
92 Sl«t- 130.
Inforauinn.
•niUbtlily
lo public.
7 USC IJ6a.
FIFRA Compliance/Enforcement
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Chapter One FIFBA
"(A) discloses maufaciuring or quality control processes,
"(B) discloses the details of any methods for testing, detecting, or
measuring the quantity of any delibrately 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
(I) 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 in .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-j%; "(e) Disclosure to Contractors.—Information otherwise protected from
9i SIM. *ji. 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 (he opi-
nion of.theAdjninistiator, such .disclosure is oecessary for-the satisfactory per-
formance foy the contractor of a contract with the United Slates 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 (he person receiving it
take such security precautions respecting the information as the Administrator
shall by regulation prescribe.
P.L. 95-3%: "(0 Penally for disclosure^ by Federal Employees.—
97 Sl" "' " "(I) Any officer or employee of the United States or former officer
or employee of the United Slates 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 that disclosure of such^material is-prohibited 'foy such
.subsection, willfully .discloses the material Jn any manner to any person
not entitled to "receive it, shall be'fined not more than $10,000 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
tnis section, or any employee of.any such contractor^ shall be considered
to toe atttroployeerof the United States.
P.L. »$0%: "(g) Disclosure to Foreign and Multinational Pesticide Producers.—
92 Sl" *JI- "(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
FIFRA Compliance/Enforcement1-32Guidance Manual 1983
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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 lo 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. TI>S<
"(a) In General.—No regulations prescribed by the Administrator for car-
rying out the 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 to distribuie, 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 not 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 to 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< lifa-
7 use u*».
' use U6f.
FIPRA Compliance/Enforcement
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Chapter One
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1 USC IJ6a.
7 USC !3Aa.
P.L. 95-396;
92 Sin. «32.
7 USC 136k:
7 USC I3AJ.
7 USC IJ6c.
"J USC I.We. JJM.
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) *'ho is a registrant, wholesaler, dealer, retailer, or other
distributor to advertise a produce registered under this Act for
restricted use without giving the 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 asiprovided 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 pan of any application for
registration, application for experimental use permit, any informa-
tion submitted to the 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 (I)
of subsection
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Chapter One
FIFRA
visions or 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 (he
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 (Plis 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 (he provisions of the Act or the laws of any jurisdic-
tion in which sold, (he court may direct that such pesticide or device be
delivered to the owner (hereof. The proceedings of such condemnation cases
shall conform, as near as may be to (he 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
(he 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.—
"(I) /" 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 53,000 for each offense.
"(2) Private Applicator.—Any private applicator or other person not
included in paragraph (1) 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 $1,000 for each offense: Provided,
That any applicator not included under paragraph (I) 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 5500 for the first offense nor more than
51,000 for each subsequent offense.
V USC IJ4I
P.L. VJ-J96:
<>l Slai. »32
FTJPRA Compliance/Enforcement
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Chapter One
FIPKA
p I Y«. m:
9: Siai XVI
7 USC Ufci
"(3) Hearing.—Ho 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.
"(4) Determination of Penally.—In determining the amount of
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 penally 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 .51,000, or imprisoned for not .more than 30 days, or
both.
"(3) Disclosure of information.—Any person, who, with intent to
defraud, uses or reveals information relative to formulas of products ac-
quired under the authority of section 3, shall be fined not more than
$10,000, or imprisoned for not more 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 usc i3«- "SEC. 15. INDEMNITIES.
**(a) -Retjuiremenl.—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 (1) 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 i3«*. - 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 the notice
referred to in subsection (aM I).
"(2) Special m/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/EoforceaeioF
1-36
Guidance Marm»1
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Chapter One
FIFRA
"SEC. 16. ADMINISTRATIVE PROCEDURE; JUDICIAL REVIEW. 7 USc U6.
"(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 fil- 7:sm.
-------
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 labor 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.
1 USC I3t*
I'.l . 44-
KV Siai.
"SEC. 18. EXEMPTION OF FEDERAL AGENCIES.
"The Administrator may, at his discretion, exempt any Federal or State
"agency from any provision of (his Ad if he determines that emergency condi-
lions 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 ihe Governor of
any Stale concerned if they request such determination."
7 |ISf IJ6q
7 USC IJ*d
KJStol. »44;
74 Sill. 801;
79Stat. 286:
72 Sin. 773:
15 Six 4«>.
Contract
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) •Proviuorafor tmused quantities.—^Notification of cancellation of any
.•pesticide shaD include specific -provisions for tite disposal of the unused quan-
tities of such pesticide.
1 USC IMr
KSut «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
4ttbers
-------
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;
12 Slai. «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;
89 Slai. 7?2;
7 USl I
Publication-* in
Federal Rrx'"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.
1 USC I Ml
"SEC. 23. STATE COOPERATION, AID, AND TRAINING.
"(a) Cooperative Agreements.—The Administrator may enter into
cooperative agreements with States and Indian tribes—
"(1) to delegate to any State or Indian tribe the authority to
cooperate in the enforcement of this Act through the use of its personnel
or 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 30
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
for 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.
1 use I
P.L. 9J-394;
92 Sill. 8)4.
FIFRA Compliance/Enforcement
1-39
Guidance Manual 1983
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Chapter One FIFRA
7 use .36- "SEC. 24. AUTHORITY OF STATES.
PI. »s-»6: "(a) A State may regulate the sale or use of any federally registered
97 Sl" 83! pesticide or device in the State, 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 coniinue in effect any requirements for
labeling or packaging in addition to or different from those required under
this Act.
"(c)(l) A Stale may provide registration for additional uses of federally
registered pesticides formulated for distribution and use within that
State to meet special local needs in accord with the purposes of (his Act
and if registration for such use has not previously been denied, disap-
proved, or cancelled by the Administrator. Such registration shall be
i use i)*.. 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 as provided in paragraph (3) of this subsection, advise the
State of the Administrator's intention to disapprove and the reasons
therefor, and provide (he State time to respond. The Administrator shall
not prohibit or disapprove a registration issued by a State under (his
subsection (A) on (he basis of lack of essentiality of a pesticide 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 301. use unless there exists a tolerance or exemption under the Federal Food,
Drug, and Cosmetic Act 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
i 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 tiige 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.
P.L »4 1*): "(a)(l) Regulations.— The Administrator is authorized in accordance with
the procedure described in paragraph (2), to prescribe regulations to
carry out the provisions of (his 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) f*aposed7egutations.—Ai:leasi.(tidaysTHV3r*o signing any
.proposed regulation for publication, in- the 'Federal Register, the Ad-
{"nj^, ministrator shall provide the Secretary of Agriculture with a copy of
cjM«. such 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
MLSI "'«i*: response of the Administrator with regard to the Secretary's com-
al ments..Jf_the 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 any *timc after such XMiay period notwithstanding
the -foragoingr^O^day Jnne requirement .
"(B) Final regulations. — At least 30 days prior to signing any
regulation in final form for publication in (he Federal Register, the
Publication in Administrator shall provide the Secretary of Agriculture with a copy
FnJnai Rrtiuti qf_such regulation. If the Secretary comments in writing to the Ad-
ministrator regarding any such final regulation within IS days after
receiving it, the Administrator shall publish in (he Federal Register
FIFRA Compliance/Enforcement 1-40 Guidance Manual 1983
-------
Chapter _0ne
fIFIA
(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 IS-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 b« 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.—M 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 Oert 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 due of promulgation, both Houses of
Congress adopt a concurrent resolution, the matter after the resolving clause of
which is as follows: 'That Congress disapproves the rule or regulation pro-
mulgated by the Administrator of the Environmental Protection Agency dealing
with the natter 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) EFFECTIVE DATE. — If at the end of 60 calendar days of continuous ses-
sion of Congress 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
nether 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 bees 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
soonerf than 90 calendar days of continuous session of Congress after its pro-
mulgation, unless disapproved at provided in subparagraph (A).
[Added by PL 96-539, Dec. It, 1980)
M(O 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
fine; die; and
[Added by PL 96-539, Dec.-17, 1980J
"(ii) the days OB which either House is not in- session because of an ad-
. joumnent of more than 3 days n> a day certain are excluded in the computa-
tion of-66 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.
lAdded by PL 96-539, Dec. 17,1580]
"(E) JUDICIAL REVIEW.—
"(D Any interested party, including any person who participated in the
. rukmalung. 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-J94;
n Slai. 836.
! Register.
P.L. 94.1*0:
KSiai. 153.
PIFRA. Compliance/Enforcement
1-41
Guidance Manual 1983
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Chapter One
FIFRA
M Slal. 1670.
15 USC Mil nolc.
P.L. M-144
l» Stot. 75*
T USC IMd.
r use u«w.
P*kU«*to» to
Foteni R«cfcttr.
OMB tMtuatloa.
JMUBCS
P.I.. »4-l*0
I*'Mil. 154
"(n> 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 States. Such appeal shall be
brought not later than 20 days after the decision of the court of appeals.
(Added.by PL 96-539, Dec. 17, 1980]
" "(iii) It shall be- the. duty of the courr of appeals and of the Supreme Court
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, 19801
"(b) Exemption of Pesticides.—The Administrator may exempt from the
requirements of this Act by regulation any pesticide which he determines either
(1) to be adequately regulated by another Federal agency, or (2) to be of a
character which is 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—
"(1) 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-
minalion that application of such provision is necessary to effectuate the
purposes of this Act;
"(5) to prescribe regulations requiring any pesticide lo be colored or
discolored if lie 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 to be used in the in-
gredient statement.
"(d) SCIENTIFIC ADVISORY PANEL.—The Administrator shall submit to an
advisory panel for comment as to I he impact on health and the environment
of the action proposal 111 nonce.-, of intent issued under section 6(b) and
of the proposed and final form of regulations issued under section- 25(a)
within the same lime periods as provided (or the comments of the Secretary
of Agriculture under such sections. The time- requirements for notices of
intem and proposed and final forms of regulation may not be modified or
waived unless in addition to meeting this requirements-of section 6(b) or
,25(a>. as-applicable, the advisory panel has .failed to comment oc the
•proposed, 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 thar lead to decisions by the Administrator
in carrying out 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 pane), after consultation- with the Administrator, may create- tem-
porary jubpaneli orr specific projects to assist the full- advisory .panel in expediting
The subpanels
may bcsuMipoaed of ^ueauhi*. 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-
nonnnees, 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 professionaj affiliations of each
nominee. Each member of the panel shallircnye jjer dieincompeacauoo at^axaxe
not,in excess of that Toed f or GS-18 of the GsnermlSchtdule as may be determined
ty the Adminsa»torvho 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 Tor 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
TTFRA 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 pand 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 ihe-environmem, the action taken to sus-
pend the-registration- of such pesticide.
lAmended by PL 96-53* Dec. 17, 19801
"(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 studies 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 chat 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 panel,
(ernuuiton.
41 USC 4365.
1 USC L36d.
1 USC U«d.
Coramcnu.
"Pt*r revkw."
PiMkatfM i*
Fcdcni
1 USC 13*- *ou.
"SEC. 26. STATE PRIMARY ENFORCEMENT RESPONSIBILITY.
"(a) For ihe 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 (he Administrator may not require a State to have pesticide
use laws that are more stringent than (his Act; .
"(2) has adopted and is implementing adequate procedures for the
enforcement of such Slate 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 (he 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 State plans under Section 4 of (his
Act in effect on September 30, 1978 not later than March 31. 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) (1) 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 IJ4--I
P.L. 95-3%;
92Sui 836.
7 USC I M«i
7 USC' IJAh
7 USC 136
7 USC 1W.I
7 USC U6»
FIFBA Compliance/Enforcement
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Guidance Manual 1983
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Chapter One
F1FRA
7 USC I36--J
P.L. 95-3%:
9: Slai. 637.
7 USC 136».|
7 USC IJ6..J
P.I.. V5.]9ft
92 Siai.ft.18.
^ list
P.l. VSJ%;
92 Slat. 838
7 USC IJ6a
PL 94-109
89 Stot Sit-
t» Slafc TU
7 USC 1M*.
PL 96-539-
94" Seat. 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 (heir
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-
tent 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 Slate program that are determined to be
inadequate. The Slate 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 Adminstrator determines
that emergency conditions exist that require immediate action on the part of
(he 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 cl'tcctivciicss of chemical, biological, and alternative methods
to combat and control pests llui reduce (he quality and economical produc-
tion and distribution of agricultural products to domestic and foreign con-
sumers.
"SKC. 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 Tiled
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 is-held invalid', ttie-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- tucrr sums as may be necessary
to carry out the provisions of" this Act for each of. the fiscal years ending
June 30: 1973, June 30, 19.7-K.and June-30. 1975: The amounts.authorized
to be appropriated for any fiscal year ending after June 30. 1975. shall be
the sum* herea/tex provided by law."
There i» hereby authorized to 'be, Appropriated to carry out the provisions
of Ais, Act -for ibe period beginning- July J-H975. and 'ending September JO,
1975, the sum of XI1,967,000,
There is hereby authorized to be appropriated to carry out the provisions
of this A a 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 out~the provir
sions of this Act for the period beginning- October 1. 1975, and ending
September 30. 1976-. the sum of J47.868.000. and for the period beginning October 1,
1976-. and ending-September 30. 1977, the sum of S46.636.000. .and for the period
*efrrming October 1. 1977, and rending -September 30. 1978. the sum of
i54.5GO.-000..-and for the--period beginning October 1. 4976. and ending Septem-
ber 30. 1979. such- sums as may be necessary, but not in excess of S70.000.000.
There are hereby authorized to be appropriated to carry out the pro visions of this
Act for the period beginning October I, 1979, and ending September 30, 1980,
such sums as may- be necessary, but nor in excess of $72,160,000, and for the
period beginning October I, 1980, and ending September 30, 1981, such sums as
may be necessary, but not in excess of $77,500,000.". <
FIFRA Compliance/Enforcement
1-44
Guidance Manual 1983
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Chanter One
FIFRA
Amendments 10 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 Dates 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 Ad, 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|. 842.
Legislative History
P.Mk L»w 92-516
«2n
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Chapter One
FLFRA
CONGRESSIONAL RECORD:
Vol. 117 (1971): Nov. 8. 9. considered and passed House.
Vol. 118 (1972): Sepl. 26, considered and passed Senaie, amended.
Oci. 5, Senaie agreed to conference report.
Oci. 12. House agreed to conference repon.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS:
Vol. 8, No. •« (1972): Oci. 21. Presidential siaiemeni.
r.Mk lj- *4-l40
Wlk Co*tnu. H. R. U4I
Nmrmbn II. 1915
HOUSE REPORTS: No. 94-497 (Comm. on Agriculture) and NO. 94-668 (Comm.
of Conference).
SENATE REPORT No. 94-452 (Comm. on Agriculture and Foresiry).
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.
S. 1*71
. If 71
HOUSE REPORTS: No. 95-343 and No. 95-343, Pi. 2, (Comm. on Agriculture) both
accompanying H.R. 7073 and No. 95-1560 (Comm. of Con-
ference).
SENATE-REPORTS: .No. 95O34 (Comm. on Agriculture. Nutrition and-Forestry) and
95-11*8 (Comm. of Conference).
CONGRESSIONAL RECORD:
Vol. 123 (1977): July 29, considered and passed Senaie.
Sepl. 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 to 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",
bul is not an amendment to FIFRA.
7 USt I36«.J
Rfporl 10
COflf r^Mon
committee.
Rtfpi"! lit
vltnyfCNMon
commiiux.
Studies
Sec..2T.
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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.
FIFRA Compliance/Enforcement 1-47' Guidance Mgrmal 1983
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Chapter One FIFRA Hegulatory Elements
JfJLTKA toraplianee/loiroreeiiientP51 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 AO C.F.R. Part 162 provide the basic authority for the registration
program.
The objectives of the pesticide registration program are to:
• 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 -Fro-m 'Registration Requirements
The following pesticides are exempt from registration requirements under
FIFRA [40 C.F.R. 5162.5(b)]:
• 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;
-r«* .Pesticides-whose registration is cancelled .under Section 6(c) of
: tiie .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 the provisions of :a. Section .18 -emergency -exemption.
FIFRA Compliance/Enforceaent 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.
New 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 CoEpliance/EnforceEent 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;
'=•• 3he .iabel must iear..the EPA Tegistratio-n-number of the "basic 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 Coapliance/Euforceaent 1-52 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.
FIFRA. Compliance/Enforcement 1-53 Guidance Manual 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/Enforcement1-54Guidance 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 PTSQiS in Washington, D.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/Enforcement 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;
FIFHA Conpliance/Enforcenent 1-56 " Guidance 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.
Canc'ellation "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.
FIFRA CoHpliance/Enforcement 1-57 Guidance Mari"a' 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-KI-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-IN-2 <
123-MA-l
FIFRA CoTHpliance/Enforceiaent 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-IH-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 Er.t. i23-Ii:-I, 2: !££.-!
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:
e 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/EruJorceKisnt 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/Enforceinent 1-60 Guidance Manual 1983
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Chapter One Establishment Registration
Confident iaii t"
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 cf Section 10
(Protection cf Trade Secrets and Other Information) 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 Conpliance/Eiiforceir.ent 1-61 Guidance Manual 1983
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Chapter One _____ Establishment Registration
FURA Compliance/Enforcement1-62 Guidance Manual 1983
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Chapter One
P £± Q1 i P i H £i P) i Q n /•"> c p
i c; o L i o i ^ w L^ i o -/ w O Cl
Authority
Under Section 19 of FIPRA, 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 a.s 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 promulgate 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 ejt s^q.) , 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 Coittpliance/Enforcer^nt 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 isovement: 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.
FIFEA CbrapHance/Enforcenent 1-64 Guidance Manual 1983
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C
i I c.
;•->-: £> """i t '"i ! i 1 C1 £Ii P £11 f" Y"f\ ] t C
i i Ifcl I LCLi Ubw i bi I I llLb
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;
PIFEA Compliance/Enforceeect1-65Guidance Kanual 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/Enforceiaent 1-66 Guidance Ma""3' 1983
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Chapter
4e Emergency Exemptions for Feciera
anc! State Agencies
Under Section 18 of FIFRA the Administrator has the authority to exempt
Federal and State 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;
o Significant economic or health problems would occur without the
use cf 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 CoK^pliance/Enforce^£z:t 1-67 Guidance Manual 1983
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Chapter One Emergency Exemptions 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 affects .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.
FIfEA CoapHance/Knforceaent Manual 1-68 Guidance Manual 1983
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Chapter tee Esvsrgenc;? Ifee-votioii'; for ^ecereJl £nd State Ageiicie."-;
Quarantine /Public Health EM
The Federal cr State agency using or applying pesticides under this exemp-
tion must :
c Maintain records of all treatments including:
Application site,
- Pesticide used,
- Rate of application, and
- Quantity used; and
e 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;
c That the time element was too critical to request a specific or
quarantine/public health exemption;
e The location, quantity, method of application, duration of applica-
tion, and qualifications of personnel involved in the application;
0 The steps being taken to reduce adverse effects; and
• Any other information requested by the Administrator.
FIFSA Coopliance/EnforceEi-ant limusl 1-63 Guidance Manual 1983
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Cnapter One Eaergency Ssesipticcjs for Federal aad State Ageacdes
Withdrawal of ^ceTUOtion
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.
FITHA tompliance/EaforceaeBt 1-70 Guidance Manual 1983
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Chapter One
f o "'" ^ i—' ^> r*' o -I* •-' o t ' ^ — r\i O r> c t i r^ i H o
I cu c; r \ o U i b u a 11 -o: i us r b o U 01U b •
Under Section 24(c) of FIFio's, 2 State is authorized to register a new end
use product for any use, or additional use of a federally registered pesti-
Conditions for Section 24(c) Registration
Tfie following conditions aust exist before a State can register a pesticide
under Section 24(c):
© Tnere is a special local need for the use within the State;
e The pesticide 73ay be distributed and used only within the regis-
tering State;
o A State iray not register a pesticide for a food or feed use unless
tolerances, exemptions, or other clearances have been issued under
the Federal Food, Drug, and Cosmetic Act; -
& Registration for the sane use has not been denied, disapproved,
suspended, or cancelled; and
The registration is in accord with the purposes of FIFRA.
Types of Section 24(c) Registrations
Section 24(c) registrations are issued either as amendements to Federal
registrations or as State-issued registrations for new products.
Amendments to Federal registrations are based on the following use provi-
sions :
c Any nev use of a federally registered pesticide;
FIFILi Co^5>liaxice/:i-afcrcai-snt 1-71 Guidance Manual 1983
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Chanter One State Re
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cs-
Glossary
ACT — When used in this manual, "the 'Act" means the Federal Insecticide,
Fungicide, and Eodenticide 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. 16789).
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.
AGENCY — 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 4 as
authorized to use or supervise the use of any pesticide that is clas-
sified for restricted use.
FTFRA 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 Compllance/Eoforcenent 1-74 Guidance Manual 1983
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Issued pursuant to 40 C.P.B., §22.17 disposing cf
a natter cf coi:~*. c"--ars" betve-n respondent end the Agency upon (1) the
failure c:-~ respondent; to file a timely answer to the co-plaint; (2) the
failure of one cf the parties to cospiy vith a prehearir.g or hearing
order of the Fresidir^ Officer, CT (3) the. failure of one cf the parties
to appear at a ccr.fcrencs or hearing without good cause being shown.
DEGRADATION PRODUCT — A substance resulting froTa the transformation of a
pesticide by physical', chemical, or electromagnetic means.
DEVICE — Any instru-ant or contrivance (other than a firearm) that is
intended for trapping, destroying, repelling, or mitigating any pest or
other form cf plant or anical life (other than humans and other than
bacteria, viruses, or other microorganisas on or in living humans or
other living animals); but net including equipment used for the
application of pcTticices when sold separately therefroa.
DISTP.ICT COURT — A United States district court, the District Court of
Guam, the District Court cf the Virgin Islands, and the highest court of
American Sarjca.
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 when used according to
label directions to control, id.Il, or induce the desired action ia the
target pest.
ENVIROiKHNT — 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 OS.DEE. — £n 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.
FIFBA Coaplifiu_ce/Ikifo7ce:..£n,> 1-75 Guidance Manual 1983
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Chacter 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 tinie 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 emulsifiers.
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 aeet 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.
^LABELING— All labels and .all other vritten, 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.
UTSBRANDED — 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 Coiapliance/Z^^orceneiit 1-76 Guidance Manual 1983
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:ch_r container or wrapping tha
:le under the narae or,
— Its labtl dees not beer the ec. tab~.ich:-:.bnt registration number.
— Any required inf cma'ion en the label or labeling is not prominently
and conspicuously placed.
— The accompanying labeling does not contain directions for use that
are necessary for e:"fec':ir:~ the purpose for which the product is
intended *
— The label doe:; not cenzcin a required naming or caution statement,
—. The label d:er: r.ct bear an ingredient statement on that part of the
immediate container that is displayed under customary conditions cf
purchase. The ir;grediar;.t s'.r.ater.en,t :.iu?t also appear on any outside
container c;r wrapper that coviceais the. statemant on the immediate
container. (The product is net r.isbr?.nded if its size and fore c;?.l:e
such placement iirpracticable and if EPA permits placement elsevhere
on the ix~ediata container or outsri.de container or wrapper.)
— The I a be!. !•:•.£; coe? r,ct contain a st£;cenent cf the use classification
under which the product is re^lrtered*
— There is no label en the ir;:::2ciate container or concealing wrapper
bearing:
t> The ijc.™.e and -::C.cri-.:c cf the producer, registrant, or person fc2
vhorj produced ;
e- The nane, brand, or trademark under which the pesticide is
sold;
o ITic? net V2.i;rht c-r aeacure of the content; and
e The required registration number and use classification.
— The pesticide is highly toxic to humans and the label does not bear:
a The sk.ull and crossbones;
0 The word "poison" prominently in red on a background of dis-
tinctly contrasting color; and
f> A statement of practical treatment (first aid or otherwise) in
case of pois'oain2 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].
Cc,-u-plianca/Z-iforcev_£:it 1-77 Guidance Manual 19S3
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CnsDter C~e Glcssa:r
NOTICt, 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, LASELEI;, A1TD RELEASED FOR SHIPMENT — The term, "packaged,
labeled, and released for ship-cent" defines that point in the producing-
marketiiig 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 the channels of 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 pr&sumptica 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 into .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.
TERSCTN — Any individual, partnership, association, corporation, or any
organized group of persons whether incorporated or not.
FIFKA Compliance/Enforcement 1-78 Guidance Manual 1983
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ClO :-••.':-"
or other tr.icrco-'.^jr.ni;"' (except virusec ; Decteria , or other r.jicrcorgani.'F. ::
en or in livinv cur. ?.;.:.-.:• or oth = r living animals) thai the Administrator
declarer t:; be r ;:-.••:" ur.c -:: Section l:5(c)(l} and under 40 C-,F-,R.. 5162-1^
PESTICIDE — Any substance or r:i::tur£. of substances iri.ten.ddc fcr preven-
ting, destroying, repelling, or -litigating any pest, or any substance or
mixture of sv.b£. tan-ess intended for use as a plant regulator, defoliant: _,
or dessieant ,
PESTICIDZ FORMULATION — T^;a substp.ace or mixture cf substances coicprised
of all active ar.d inert (if any) ingredients of a pesticide product.
PESTICIDE PlIC'ExC! --- A r..5Stic.iGe offered as a cc~-:iiercial product, conplete
vith c.c\:iv^ ?/: :! i;.::::. (:'.:: arij1) ir gr^iients , in z cci^ciiner havi-^ a
PETITIGXEIl — Ai-iy p-rs-cn: ;..rver- •;.!;•. affected by a notice of the
Advainis cr r.cr-r and who requests a public hearing.
Adainistr?£ive La1,? Judge to serve as the Presiding Officer of an admin-
istrative hearing arising cj.r cf the Act,
PRIVATE APPLICATOR — A certified applicator T.-rho uses or £upe"/ises the ur>e
of any pe"ti?.?ldc- classified for restricted usa for purposes of producing
any ajricult.ural coir^cdity en property cv.-p.ed • or rented by the applicator
or tb.2 applicatcr's eT^ployer or (if applied without compensation other
than trading of personal services betveen producers or agricultural
coiunoditie;} en the property cf another person.
FR.ODUCE — To manuf actura, prepare, propagate, compound, or process any
pecticice, 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 terva also ueans to repackage or cthervise change
the container cf any pesticide, active, ingredient, or device. "Produce."
does not mean to d.ilute, mi:-:, 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 ADrilldSTHATCa —• The Administrator (or delegate) of a Regional
Office of the Agency.
r.:ylii1.ri.ce/£'iforce:'iat 1-79 Guidance lisoiual 1933
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Charter Cr:e Glossar
RZGIONAL HEARING CLERK — An individual duly authorized by the Regional
Adisiriis crater tc serve as hearing clerk for a given Region. Correspon-
dence n.ay te addressed to t:.a Regional Hearing Clerk, United States
Environmental Protection Agency (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 envirom'-ynt (including husans), following the use cf
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, cr for one or more of such uses, or in
accordance with a widespread and commonly recognized practice, cay
generally cause without additional regulatory restrictions, unreasonable
adverse effects en the er_vironn;.er;.t.
SPECIAL LQCAL .TEED — A pes_ vrcblea (existing or imminent within a State)
that cannot be effectively controlled because an appropriate EPA-
registered pesticide product: is not available.
UNDER TEE .DIRECT SUPERVISION CF 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
•pTotable violatio-ns 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;
FIFRA Coiapliaiuce/Siiforcerieut 1-80 Guidance Manual 1983
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Chapter -C-j-g Glossr.ry
— Stcraro ret:', en.?. :'-.: pesticides arc pesticide containers: and
— Dispos".!. act: or.t l:r; pesticides a-.c, pesticide cc^taincrs.
Use E: dsfizi :1 l.^rc. incorporates applicatic-.i:. However, the certifies--
tier. r?.c:ui:'i--^r.t for certain restricted use pesticides only applies vfith
respect, to £7-piicf.tior.« of such pesticides. Many aspects cf use do net
include application (e.g., storage or transportation), and hence are
outside the requirersnt for certification.
FIF2A CoKplisace/Ziiforc=:.vir.t T-IT Guidance Manual 1983
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FIF2A Compliance/Enforcement 1-82 Guidance H»«*«*l 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 Coopliance/Enforceaent 2-1 Guidance Manual 1953
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Chapter Two Contents
PlP&A. CtmpU*nce/Bnforce»ent 2-ii Guidance NnnuUL
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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 noncompllance;
• Evaluates the technical sufficiency of actions designed to remedy
violations;
FIFRA Compliance/Enforcement 2-1 Quidi""** F
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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 failing 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 wfaeuevw 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.
rxFMA TTtmTI "I snrr jinnTnrrraff lit 2-2 w*dwtcy •'•"wil 1983
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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 FIFBA;
• 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.
firmA uoBp.uance/anxorceaent z-o Guidance
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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's civil penalty proceedings); and
« Represents the Agency In national suspension and cancellation pro-
ceedings.
Iweatlgatlon flenter (lEIC)
HEIC is located in Denver, Colorado, and functions as a national technical
resource and investigative unit. HEIC's 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 EEIC In cases that have preceden-
Lonal in nature.
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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;
• 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
FIFRA 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. Under the cooperative .enforce-
ment agreements, State personnel are responsible for conducting -in-
spections under both FIFRA and the State 'a pesticide lavs. During
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.
FITKA compliance/ ooxorcement £-2 Gaidar""* M****"1 1983
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Chapter Two General Operating Procedi
• Enforcement Activities. Dnder 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 rmspqnsibillty .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.
Dnder 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
ylgnlflrsnT case so a State, the agency mill contact the State to
1-earn^the Terults 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 expedltiously to the referral; and (3) documented all
inculpatory or exculpatory events or information. If the Region
cannot negotiate an
ilaimsr Igsfinn ••fcer ?aotice sto *fae State, "that
notce 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 will initiate its own inves-
tigation.
e Enforcement Activities. Under primacy, a State has 30 days
following sffer •completion of -toe
sa^pTOfirtst^--satforcammnt- -auction. The • -Region may extend this period
if required by the procedural characteristics of the State's
regulatory structure.
2-6 gn^-""* Manual 1983
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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 PIFRA.
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 FIFBA 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.
JT.LFMA compliance/isnxorcement /-/ Guidance nsirosi 19IS3
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Chapter Two General Operating Procedt
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Chapter Two
Organizational Charts
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FffM. CoMpliance/Enfor
2-9
1983
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Chapter Two
Orgmalxatlonal Charts
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2-10
Manual 1983
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Chapter Two
Organizational Charts
orrice OF PCSTICIKS AND TOIIC SUBSTANCES
OFFICE OF THE ASSISTANT ADMINISTRATOR
OFFICE OF PESTICIDES
AND TOXIC SUBSTANCES
ASSISTANT ADMINISTRATOR
SCIENCE AMD POLICY
ANALYSIS STAFF
EXECUTIVE DIRECTOR
SPECIAL ASSISTANT
REGULATORY
REFORM STAFF
COMPLIANCE
NONI TORINO
STAFF
ADMINISTRATION
BUDGET AND FEDERAL
REGISTER STAFF
CHEMICAL
COORDINATION
STAFf
DIRECTOR'S
OFFICE
POLICY AND GRANTS
UNIT
FXFBA
or
2-11
ial 19111.
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Chapter Two
Organizational Charts
OFFICE OF PESTICIDE PROGRAMS
OFFICE OF THE DIRECTOR
Office Dlrtctor
Deputy Office Director
PROGRAM MANAGEMENT
4 a SUPPORT DIVISION
ADMINISTRATION ,«AMCH
RESOURCE MGMT. &
EVALUATION BRANCH
INFORMATION SERVICES
BRANCH
BENEFITS & USC
DIVISION
IBM t PROGRAM
COORDINATION STAFF
NATIONAL LAB. AUDIT
PROGRAM STAFF
CHEMICAL
OPERATIONS BRANCH
SCIENCE SUPPORT
BRANCH
ECONOMIC ANALYSIS
BRANCH
POLICY S SPECIAL PROJECTS
STAFF
HAZARD EVALUATION
DIVISION
TOXICOLOGY BRANCH
E90SURE ASSESSMENT
BRANCH
ECOLOGICAL EFFECTS
•RANCH
RESIDUE CHEMISTRY
1 BRANCH
SCIENCE INTEGRATION
STAFF
MANAGEMENT SUPPORT
STAFF
ADMINISTRATIVE
STAFF
REGISTRATION DIVISION
Dlrtctor
Deputy Director
PROGRAM COORDINATION
STAFF
I
•JCME-
MJRANCH
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lANAGEMENT
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+
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1
HERBICIDE
FUN6JC1IWE BRANCH .
PRODUCT MANAGEMENT
TEAM 121
PROOUCT MANAGEMENT
TEAM 123
PROOUCT MANAGEMENT
TEAM 125
TECHNICAL SUPPORT
SECTION
- «••
NP
MM
mm
1
BISMFECTANT
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PRODUCT MANAGEMENT
TEAM 131
PROOUCT MANAGEMENT
, .TE4M.J32
TECHNICAL SUPPORT
SECTION
-
-
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1
1EBISTRATION SUPPORT
"1
EMERGENCY RESPONSE
BRANCH
REGISTRATION SUPPORT
1 ANALYSIS SECTION
EMERGENCY RESPONSE
•SECTION
TECHliiai SUPPORT
- SECTION
RISK BENEFIT
SECTION
JL
SPECIAL PROJECTS
SECTION
1-12
19S3
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Chapter Tiro
tnt"i T"^ QiflTts
REEIW I
REPORTS TO
HQ OFFICE OF LEGAL AND
ENFORCEMENT COUNSEL
REGIONAL ADMINISTRATOR
DEPuTT
REGIONAL ADMINISTRATOR
OFFICE OF
INTERGOVERNMENTAL
LIAISON
•^(advisory to)
OFFICE OF
PUBLIC AFFAIRS
ADMINISTRATIVE
SERVICES DIVISION
AIR MANAGEMENT
DIVISION
HASTE MANAGEMENT
DIVISION
MATER 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 WASTE
PROGRAMS BRANCH
HASTE RESPONSE
AND COMPLIANCE
BRANCH
TECHNICAL SUPPORT
BRANCH
GRANTS AON. AND
FINANCE BRANCH
OFFICE OF
4 PROGRAM SUPPORT
MUNICIPAL
FACILITIES
BRANCH
TECHNICAL SUPPORT
BRANCH
SURVEILLANCE
BRANCH
HATER SUPPLY
BRANCH
WATER QUALITY
BRANCH
FI7KA CoapH «nce/Bnf orcocnt
2-13
Cbrff«*•*•'*«»
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Chapter Two
Organisational Charts
REGION II
REPORTS 70
HQ OFFICE OF LEGAL Mft
ENFORCEMENT COUNSEL
RESIDUAL ADMINISTRATOR
DEPUTY REGIONAL
ADMINISTRATOR
ASSISTANT REGIONAL
AOMINISTMTOR
FOR POLICY AND
DEPUTY DIRECTOR
EEO OFFICER
PERSONNEL 4 ORGANIZATION
•RANCH
INFORMATION SrSTSMS
ENVIRONMENTAL IMPACTS
POLICY 4 PROGRAM
INTEGRATION BRANCH
FINANCIAL MANAGEMENT
BRANCH
FACILITIES 4 ADMINISTRATIVE
NAHAGCMENT BRANCH
WOTS HBMINISTIATION
, MANCH
PERMITS ADMINISTRATION
PLANNING 4 EVALUATION
BRANCH
AIR AND HASTE
MANAGEMENT
DIVISION
J&UTY OUtECTOa
•«atfrlsofy to)
REGIONAL COONSa
CONGRESSIONAL AND
INTERfiOVERNNEMTAL LIAISON
HATER MANAGEMENT
DIVISION
\
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Chapter Two
OrganizationalCharts
REGION HI
ASSISTANT REGIONAL
ADMINISTRATOR
FOR POLICY AND
MANAGEMENT
REGIONAL ADMINISTRATOR
DEPUTY
REGIONAL ADMINISTRATOR
. EEO OFFICER
MANAGEMENT
ADMINISTRATION
BRANCH
. COMPTROLLER
PERSONNEL
MANAGEMENT
•RANCH
STATE PROGRAMS
BRANCH
ENVIRONMENTAL
IMPACT BRANCH
REPORTS TO
HO OFFICE OF LEGAL AND
ENFORCEMENT COUNSEL
•^(advisory to)
OFFICE OF
CONGRESSIONAL AND
INTERGOVERNMENTAL
LIAISON
OFFICE OF
PUBLIC AFFAIRS
AIR AND HASTE
MANAGEMENT DIVISION
DEPUTY DIRECTOR
AIR PROGRAMS AND
J ENERGY BRANCH
HATER PROGRAM
DIVISION
DEPUTY DIRECTOR
AIR AND HASTE
COMPLIANCE
HASTE
MANAGEMENT
BRANCH
HATER PROGRAM
MANAGEMENT i
SUPPORT BRANCH
MD/DEM/DC
BRANCH
PA/WV
HATER SUPPLY
•RANCH
MATER PERMITS
BRANCH
ENVIRONMENTAL
SERVICES DIVISION
DEPUTY DIRECTOR
WESTERN REGIONAL
LABORATORY AND
4 ENVIRONMENTAL
CENTER
HHEELING, HV
CENTRAL REGIONAL
LABORATORY
ANNAPOLIS, MD
ENYIRpNMENTAL
EMERGENCY
BRANCH
AIR QUALITY
MONITORING BRANCH
HATER QUALITY
4 MONITORING STAFF
7XFBA
2-15
Culdi
1983
-------
Chapter
Organizational Charts
REGION IV
RETORTS TO
HQ OFFICE OF LEGAL AND
ENFORCEMENT COUNSEL
REGIONAL ADMINISTRATOR
DEPUTY
RESIDUAL ADMINISTRATOR
ASSISTANT REGIONAL
ADMINISTRATOR
Ft» POLICY AND
MANAGEMENT
EEO OFFICER
OnriKOCIfTAL
ASSESSMENT
BRANCH
MANASEMENT
BRANCH
PERSONNEL AND
, ORGANIZATION
BRANCH
WLICY AMD
PROGRAM
EVALUATION BRANCH
BUDGET
OFFICE
HATER MANAGEMENT
DIVISION
DEPUTY DIRECTOR
FACILITIES
PERFORMANCE
BRANCH
BRANCH
EMERGENCY AND
4«ENEOIAL RESPONSE
BRANCH
MATER
SUPPLY
BRANCH
•^Badvisory to)
OFFICE OF
CONGRESSIONAL AND
EXTERNAL AFFAIRS
AIR AND HASTE
MANAGEMENT
DIVISION
. DEPUTY DIRECTOR
ttSIWALS
1WWASEKEWT
BRANCH
PESTICIDES AND
TOXICS
BRANCH
ENVIRONMENTAL
SERVICES
DIVISION
. DEPUTY DIRECTOR
ANALYTICAL
SUPPORT
BRANCH
ECOLOGICAL
SUPPORT
ENGINEERING
SUPPORT
BRANCH
JURHAMSEMENT
- :«11WCH
FXFEA Camplf anRC/Boforcgaent
2-16
1983
-------
Chapter Two
Organisational 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
WASTE
MANAGEMENT
DIVISION
DEPUTY DIRECTOR
WASTE
MANAGEMENT
BRANCH
REMEDIAL
RESPONSE
BRANCH
TOXIC
SUBSTANCES
BRANCH
0
HATER
MANAGEMENT
DIVISION
lEPUTY DIRECTOR
HATER
QUALITY
BRANCH
MUNICIPAL
FACILITIES
BRANCH
DRINKING HATER
/GROUNDHATER
PROTECTION
BRANCH
0
ENVIRONMENTAL
SERVICES
DIVISION
CPUTY 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
NORTHER* DIVISION
DEPUTY DIRECTOR
Tf&f
TUBA. C
111
or
2-17
Manual 1983
-------
Chapter Two
Organisational Charts
REGION VI
REPORTS TO
HQ OFFICE OF LEGAL AND
ENFORCEMENT COUNSEL
A
REGIONAL ADMINISTRATOR
DEPUTY
REGIONAL ADMINISTRATOR
ASSISTANT REGIONAL
ADMINISTRATOR
FOR MANAGEMENT
DEPUTY DIRECTOR
EEO OFFICER
PERSONNEL
SERVICES BRANCH
*ALTH 4 SAFETY
OFFICER
RESOURCES MANAGEMENT
BRANCH
REGIONAL
COMPTROLLER
GRANTS ADMINISTRATION
BRANCH
MANAGEMENT SERVICES
BRANCH
I
AIR AND HASTE
MANAGEMENT
DIVISION
DEPUTY DIRECTOR
•^(advisory to)
OFFICE OF
CONGRESSIONAL AND
INTERGOVERNMENTAL
LIAISON
DFFICE OF
PUBLIC AFFAIRS
HATER
MANAGEMENT
DIVISION
DEPUTY DIRECTOR
AIR BRANCH
HAZARDOUS
4 MATERIALS
BRANCH
PESTICIDES*
' TOXICS
BRAHCH
ENVIRONMENTAL
SERVICES
DIVISION
DEPUTY DIRECTOR
"CONSTRUCTION
GRANTS
BRANCH
ENFORCEMENT
BRANCH
.. - «ANCH
VATEI DUALITY
MANAGEMENT
BRANCH
-SWR.T
BRANCH
EMERGENCY
RESPONSE
BRANCH
FEDERAL
ACTIVITIES
BRANCH
SWYEJLLANCE
• •• • *UUCH
HOUSTON
BRANCH
OFFICE OF
DUALITY
ASSURANCE
FTFBA Owpl.i«nce/Bnf OT M mt. u t
2-18
1983
-------
Chapter Two
lffl'M«T>a1
RESIGN VII
REPORTS TO
HQ OFFICE OF LEGAL AND
ENFORCEMENT COUNSEL
REGIONAL ADMINISTRATOR
DEPUTY
REGIONAL ADMINISTRATOR
<« advisory to)
ASSISTANT REGIONAL
ADMINISTRATOR
FOR POLICY AND
MANAGEMENT
REGIONAL COMPTROLLER
BRANCH
ADMINISTRATIVE
SERVICES BRANCH
PERSONNEL AND
ORGANIZATION BRANCH
ENVIRONMENTAL REVIEW
BRANCH
_L
CONGRESSIONAL AND
INTERGOVERNMENTAL
RELATIONS
OFFICE OF
PUBLIC AFFAIRS
AIR AND WASTE
MANAGEMENT
DIVISION
DEPUTY DIRECTOR
HATER
MANAGEMENT
DIVISION
DEPUTY DIRECTOR
ENVIRONMENTAL
SERVICES
DIVISION
AIR AND WASTE
COMPLIANCE
BRANCH
HASTE
MANAGEMENT
BRANCH
AIR
BRANCH
CONSTRUCTION
GRANTS
BRANCH
DRINKING MATER
BRANCH
MATER
COMPLIANCE
BRANCH
RAD
COORDINATION
OA
OFFICER
LABORATORY
BRANCH
FIELD
INVESTIGATION
BRANCH
EMERGENCY
PLANNING A
RESPONSE BRANCH
FTJXA Covpliance/Baf or
2-19
Guidance
1983
-------
Chapter Two
Organisational Charts
REGION Till
REPORTS TO
HQ OFFICE OF LEGAL AND
ENFORCEMENT COUNSEL
REGIONAL ADMINISTRATOR
DEPUTY
REGIONAL ADMINISTRATOR
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
BUNCH
ENVIRONMENTAL
ASSESSMENT BRANCH
RESOURCE PLANNING
AND MANAGEMENT
AIR AND WASTE
MANAGEMENT
DIVISION
AIR PROGRAMS
BRANCH
TOXIC
SUBSTANCES
BRANCH
HftSTE
BRANCH
OFFICE OF
RADIATION
. MOGRAMS
CONGRESSIONAL AND
INTERGOVERNMENTAL
RELATIONS
MONTANA
OPERATIONS
OFFICE
OFFICE OF
PUBLIC AFFAIRS
:• UftTER
MANAGEMENT
DIVISION
COMPLIANCE
BRANCH
MUNICIPAL
FACILITIES
BRANCH
'PROGRAMS
BRANCH
DRINKING MATER
BRANCH
*
ENVIRONMENTAL
SERVICES
DIVISION
FIELD
OPERATIONS
BRANCH
ANALYTICAL
SUPPORT BRANCH
(LABORATORY)
RESPONSE
MUNCH
DATA
ANALYSIS
•RANCH
FD1A Coayllance/ftif<
2-20
CnIA*
Manual 1983
-------
Chapter Two
Organizational Charts
REGION IX
REPORTS TO
HQ OFFICE OF LEGAL AND
ENFORCEMENT COUNSEL
RESIDUAL ADMINISTRATOR
DEPUTY
REGIONAL ADMINISTRATOR
OFFICE OF POLICY
AND RESOURCES
MANAGEMENT
COMPTROLLER
MANAGEMENT SYSTEMS
4 EVALUATION BRANCH
-<{advisory to)
REGIONAL
COUNSEL
OFFICE OF
CONGRESSIONAL AND
INTERGOVERNMENTAL
LIAISON
OFFICE OF
PUBLIC AFFAIRS
ADMINISTRATIVE
SERVICES DIVISION
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
VS1A Coapllance/Bof or<
2-21
1983
-------
Chapter Two
Organizational Charts
REGION X
RETORTS TO
HQ OFFICE OF LEGAL AND
ENFORCEMENT COUNSEL
REGIONAL ADMINISTRATOR
DEPUTY
REGIONAL ADMINISTRATOR
ALASKA OFFICE
OREGON OFFICE
ItASHINGTON OFFICE
to)
REGIONAL
COUNSEL
CONGRESSIONAL AND
INTERGOVERNMENTAL
RELATIONS
OFFICE OF
4HBLICAFFAIRS
MANAGENENT
DIVISION
EEO OFFICER
i '
• • -fniMict
OFFICER
PERSONNEL
, t ^BNUUSTRAfiyE • -'
, , ^SDnriCES . •:
BRANCH
.-GRANTS m
. ADNINISTRATION
•RANCH
. *'*
AIR AND HASTE
MANAGENENT
; ; DIVISION
AIR BRANCH '
SUPERFUND
BRANCH
RCRA BRANCH
; «DIATI«I «A«C« :
MATER
DIVISION
COMPLIANCE
BRANCH
CONSTRUCTION
. GRANTS BRANCH
MATER QUALITY
BRANCH
"' ' - , mawam
'••••" • lKlf&
ENVIRONMENTAL
SERVICES DIVISION
TECHNICAL
SUPPORT
BRANCH
FIELD OPERATIONS
BRANCH
(LABORATORY)
EMERGENCY
RESPONSE
COORDINATOR
FZFBA Coaiplijaice/Bnxorc
2-22
Manual 1989
-------
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
FIFBA Caapllance/Enfor
-------
Chapter Three Contents
umpxionce/BixorcaKnt a—xa. &vi «*•«•.• Manual 1983
-------
Chapter Three
1 Introduction
Compliance Monitoring is a term used to describe the Means 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.
1983
-------
Chapter Three
Introduction
f UlA. doaplJjmce/Balio
3-2
1993
-------
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
FIFRA 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 "No 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 Qvldmnr* Manual 1983
-------
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
Statements 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.
FLFRA Covpllance/Bnf orceaent 3-4 O^IA**** Msansl 1983
-------
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 pesticide!
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 FIPRA 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 pesticldal devices are held for distribution
or sale. Samples may be taken of pesticides and pesticldal devices
released for shipment. Samples may also be taken of any container or label
for such pesticides or pesticidal devices.
3-5 Goldi
-------
Chapter Three Records and Establishment Inspections
The scope of establishment Inspection does not extend into manufacturing,
femulating, 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 pestlcidal 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;
e To document suspected violations.
Elements of an Inspection
The elements of FIFRA facility inspections can be grouped into the fol-
K (1) pr^iiMp»ftiM pMparatlon; (2) entry; (3)
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.IFKA Camllance/Enforceaent 3-6 t^t^^^f. jft~««i t
-------
Chapter Three Records and KatabLi °**wTit Inspections
Pre-Inapection 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.
7HtA Compliance/Enforcement3-7 4**mmrt~ Mesas!
-------
Chapter Three Records and Kstablls
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 all inspection activities;
• Inspecting conditions and taking photographs, If necessary;
• Taking necessary samples, sealing samples, and establishing "chain
of custody"; and
• Operating In a *afe 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;
• Harratlve report; and
• Other documentary support.
«rld«nee. tejr information -needing clarification should be levlewed
with the Inspector.
FIFRA Compliance/Enforcement 3-8
-------
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 Bade 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 FIPRA Inspection Mrim*!, 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
3-9
-------
Chapter Three Dae/Misuse Investigation
authority to conduct use/misuse investigations. Nonetheless, the following
statutory and common lav 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 [FIFRA S9(b)*] authorizing
entry .for 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
'nft of a^cCTM^Tcial 'i^a't'l5*'id* *pp] ^ rT .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
jgMuist -of duress, /mlsj;epiesent«tion, cr coercion) ty the owner, ills
«r ber ^«gent , «or the person In "charge of toe -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 FIFRA authorizes employees duly designated by the
Administrator to obtain Inspection warrants In order to enter a facility
for purposes of JLaspectlng -and »«tmn1 1 ng ±f tbare la "probable -cause* to
of
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 FIFRA have been violated.
FIFRA Compliance/enforcement 3-10 ani^r^.m Manual 1983
-------
Chapter Three Use/Misuse Investigation
• Exigent Circumstances. If a serious situation exists, such as the
endangerment of human health or public safety occurring on private
property, an inspector nay enter the property to assist in preven-
ting the harm when:
- There is insufficient tine 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 prem-
ises (such as to conduct nonltoring 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.
3-11 PnUmf*
-------
Chapter Three
Use/Misuse Investigation
3-12
-------
Chapter Three
2c Warrants
A warrant can be used to gain entry into a facility when 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 5ftf|d«iw«» HI»«»«*I 1983
-------
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 FXFRA 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 matter 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 aucb 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, Heutral 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-lnspectionwarrant may be obtained :at the discretion of
"the xcgitmal 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
• is
procedures, noncompliance with regulatory requirements, a civil warrant
should be secured if entry is refused.
FTFRA
-------
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. Bather, 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 Adminls trat1ve 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
FITCA Compliance/mtorcement 3-15 Aii^*^** Meaaai 1983
-------
Chapter Three Warrants
rise to the need for a pre-inspection warrant. 'A joint
determination will then be nade 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 10 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 tbe,a one* or two-page docoment 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. Bach 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 that 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 JT.J*. Marshal Is ^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
FIFIA Compliance/Eof orcement 3-16 K^IA^^ M^M! 1983
-------
Chapter Three Warrants
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.
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
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Chapter Three *-**»•*bit 3—1
Model Affidavit la Support of Application for a Warrant
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,
aadaodentieide Act , as -amended , for the inspection and/or
of the items named below In the pos session , custody , or con-
trol of the (name of company or owner).
2. This warrant is sought under Section 9 of the Federal Insec-
ticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. Sl36g),
which provides:
"(b) WARRANTS. —For purposes of enforcing the provisions of
Kr or court .of
competent jurisdiction that there is reason to believe that
the provisions of this Act have been violated, officers or
employees duly designated by the Administrator are
•red to obtain and to execute warrants authorizing-—
**(!) entry for the purpose of this section;
—<2) la«p»rtiop^nd ^zmprodnctian «f ^all ncords stowing
quantity, date of shipment, and the name of consignor
and consignee of any pesticide or device found in the
establishment which is adulterated, mlsbranded, not
registered (in the case of a pesticide) or otherwise in
violation of this Act and in the event of the inability
l 4 ~
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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 Rodenticide Act, as amended. This belief is based upon
the following facts and information: (Summarise 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).
FIFBA Ctmp^ * rn"^fv*tfnri^^^nt' 3-19 Guidance Manna).. J.JS3
-------
Chapter Three Exhibit 3-1
(Signature of Affiant)
(Title)
(Division)
legion ( )
United States Environmental Protection Agency
Before ae, 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 Rotary Public of
My Commission Expires
3-20 f^^tinc^ Mr*-**1 1983
-------
Chapter Three »^»
-------
Chapter Three \ Exhibit 3-2
Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act, as
amended, 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 atop,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 sane to (facility owner or agent) on (date)
at (location of establishment or place) .
(Signature of person making service)
(Official title)
RETURN
;-tbe >«staUi«mBcn£ *«teocxl&ed ..In . tixLm 'Mrxant ^mas -completed
(date) »
vre trf -'pexston: Fny^TT vl I in? -ifap ^""pg ctton)
TCFRA, Compliance/Enforcement 3—22 fy^ar**^ MMM! 1983
-------
Chapter Three
3 Subpoenas
FIFRA does not provide for subpoena authority.*
Except under FIFRA 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 FIFRA Section 6(b).
FXFKA compliance/Boxorcement 3-iJ c^f^y"* n«mai 1983
-------
Chapter Three Sobpoeuai
3-2
-------
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
Processing of the ID Jacket— Enforcement
Case Beviev 4-11
Additional Sources of Documentation ' 4-12
CDapxiance/aaxorcaaenc 4-1 Guidance nairrf' I9o3
-------
Chapter Four Contents
1M3
-------
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 pesticidal
device casple. Once compiled, the f He is «ent to a Regional Case Develop-
ment Officer (RCDO) who reviews the inspection results for possible
enforcement action*
uovpJJLance/iaixorceaent 4—1 Guidance Manual. 1983
-------
Chapter Four _ Introduction
FIFKA Cb«pliance/Enforce»ent 4-2 gnUyir* ffe"^1 1983
-------
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, ^aa "well as jan 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
accessary, the; aCDO should obtain from fcne inspector additional evidence or
^clrarif icB.ti
-------
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 investiga-
tlonal.
Official Samples. These include samples or documents of pesticides or
devices that, if vlolative, 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
-------
Chapter Four Inspection File Review
• Induced Samples. Actual samples of pesticides or pestlcldal
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 pestlcldal devices
that are offered for Importation Into the United States from a for*
elgn port. Proper documentation for Import shipments should
. include (^stoms 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.
Investigational 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 Investigational
samples.
FIFKA Covpllance/Enforceaent 4-5 Guidance Manual 1983
-------
Chapter Four Inspection File Review
FIFKA Compliance/Enforcement 4H»Guidance Manual 1983
-------
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 the following considerations:
• 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 ---the
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
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
. ^t|Bvfl^^s^F9^B^^^B^^^ -"'4»OlCi8HB>HisCil'^t^u031 "^^Onif ?it^&&~*>^Httl- '^R^uQi^LftXii^bDXX^ ' -^^FOI^C ^^BflEiUQD^L^K-*- '' ^tl^lifl ••-iBBrnMT
"require fffiheT 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.
FIFEA Ckmpliance/Enforceaent 4-7 Guidance Manual 1983
-------
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,
subs ample 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 poet-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
Che ID Jacket by laboratory personnel once the physical cample has been
received by the laboratory for analysis. It shows whether Che integrity of
Che sample has been maintained during its stay aC Che laboratory. Each
time Che sample seal is broken and resealed, it vist be noted on Che form.
It is important for the RCDO to demonstrate Chat none of Che samples
involved in Che case preparation have been tampered with or contaminated
during collection, transit, storage, or analysis. An accurate accounting
FIFRA Compliance/Enforcement 4-8 Guidance Manual 1983
-------
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*. Teat 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.-metbod 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
^completion of toe analysis * 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 of the product.
'Other ^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-
cumstances .^urxaundi ng the lyloiation. 1^tr«f«d rcvler vbould be
•-•imde tqf the .rnffid«vlt 'lor Agvldence Imropport t>f an enforcement
action. The person making the affidavit must sign it and be able
to personally verify the facts contained in the statement.
FIFRA Ckmpliance/Enforceaent 4-9 Guidance Manual 1983
-------
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 oust 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 Caapliance/Baforceaent 4-10 Guidance Manual 1983
-------
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.
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 :FrocegBiTag'-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* Jn .some -instances the -Region jaay Also wish to know whether a
T*tr* "tTatlO" ^ P BUBpfTViffl ffT
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 pesticldal in nature and if so whether or not they are exempt from
EPA regulation.
^collected '-ws T*rt of «n
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
FIFRA Govpllance/Enforceaent 4-11 Guidance *«•"*» 1983
-------
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 pesticidal
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;
FIFBA Compliance/Enforcement 4-12 Guidance Manual 1983
-------
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.
i
FIFRA Covpllance/Enforceaent
4-13
Guidance Manual 1983
-------
Chapter Four
Rgriew of Adequacy of Evidence
,v*
FIFKA Compliance/Enforcement
4-14
Guidance Manual 1983
-------
ChapterFour
Contents
Compliance/Bafor
4-ii
1983
-------
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 JJIB pec tor relating, to ^n official pesticide or pesticidal
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.
FIFRA ump.Ll.anee/lanzorceBent A—I Guidance Manual 1983
-------
Chapter Four Introduction
FlfEA CPapllance/Koforceaent 4-2 Guidance Manual 1983
-------
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 -well as an interpretation ^f laboratory test .results.
In all -cases, the HCDO 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
, ,thg 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
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;
FIFRA umpllance/BoforeeBent 4-3 r>H^flnge Manual 1983
-------
Chapter Four Inspection FileReview
• 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-
tiotxal.
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/Enforcement5^3Guidance Manual 1
-------
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 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 pesticidal 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.
Investigational 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 investigational
samples.
FIFKA CoBplian.ee/Enforcestesit 4-5 Guidance M?**"*1 1983
-------
Chapter Four Inspection File BevicHt
FIP1A Ccwpllance/Enf orceaent 4-6 Guidance Manual 1983
-------
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) .
Adequacy of .the Joctnnfrit'
-------
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 sample 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 vist 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
FIFEA 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 aethod 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 Cest 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.
-Evl.-dcut.la3. 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. C«r*f^ review saoold be
••de «f tiie affidavit for evidence .j±n «opport of «n -enforcement
action. The person making the affidavit must sign it and be able
to personally verify the facts contained in the statement.
FIFRA Covpllance/Eaforcement 4H9Guidance 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 pesticldal 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.
FLFBA 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 """••TlT*?
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.
• Jtgylcg., ' "'Capt^s "Off "sll ;|MiiTti lilf lahfTT «"«O'i^»»*-^j -»•
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
FLFEA CoBpllance/Enforceaent 4-11 Guidance Manual 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 toxicity.
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
shoving the delivery, movements, or holding of a pesticide or pesticidal
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 might be obtained from shipping records Includes:
• Identity of pesticide or device;
• Quantity sold, received, shipped, or stored;
• Dates sold, received, or shipped;
FIFRA CoMpllance/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.
FIFRA Compliance/Enforcement^13'Guidance Manual 1983
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Chapter Four Rerleir of Adequacy of Evidence
PIFEA Compliance/Enforcement 4-14 Guidance 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
.Seizures 5—15
roceedi-ngB 5-16
Exhibit 5-1: Efficacy Standards and Level of Action
Guidance for Disinfectants and
Rodenticldes 5-18
Exhibit 5-2: Criteria for Determining the Gravity
of a Use Violation for Purposes of
a Certification Action 5-21
FIFHA OtMp3jLance/Enforcg»ent 5-1 pHi^mnfa Mannal 1983
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Chapter Five Contents
FIFB4 Compliance/Enforcement 5-1 i Guidance 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, EFA 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 Ttfae -case of stop sale , use ,, and removal orders . Hie 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);
^«**m * ******** :**£i***rmfAm*** iw»,*oi- 1p\ -^ ,"g y-p T f[ ftf T ^ .
• Denials, suspensions, modifications, or revocations of applicator
certifications under 40 C.F.R.. $171.11;
• Recall requests;
• Stop sale, use, or removal orders under Section 13(a); and
-:-;,-.« rCivll «dainia£xa£±«e fen«lti«« 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 Qn44»ni'» tff^mml 1983
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Chapter Five Introduction
Judicial actions may involve either civil or criminal proceedings. Civil
proceedings include:
• Injunctions under Section I6(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 Coapliance/Eoforceaent S-^2 Guidance Manual 1983
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Chapter Five
2 Level of Action Policy
Advertising Letters
-An advertising letter is -A letter ••issued by KEAms notice io -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
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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 simlllar circumstances);
and
FIFRA Compliance/Enforcement 5-4 Guidance M*i"*' 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
to ««b«ilt annual report** If tbr ^establishment docs not
an annual pesticides Tepxirt -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 nay also occur upon .request of
tos jgoro or TrfJ.1 go out of "business, no longer produces pesticides, or
otherwise no longer falls under the purview of FIFRA Section 7 • In such
cases the procedures for terminating establishment registration are
i«*s£ahllsiMen£s -x^ 30 ^days -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.
FIFKA umpliance/ Bororeeaent 5-5 Guidance M?™"*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 EFA 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.
§171.11 (f)(5)(i)]. 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
-------
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
viola t J.OP |
* 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 ji certification, in accordance
the following table:
Total Gravity Value Enforcement Remedy
4 or below No action or Notice of Warning
5 to 8 Suspension of up to 2 months
9 to 12 . riniff nulnn of Tirtmtrn ? and ^
tar above • - • Su*pen«i«m of jMt»««.u 4 «md ^"
To determine whether the term of a suspension should be at the higher or
lower end of the given ranges, 1PA will consider any gravity-related fac-
tors not accounted for in the gravity criteria. In addition, EPA will con-
sider £be degree *&-«9titi^^*^jmimjfmmim-:MM;-&iim i*a adv*x*e aconoaix. •*•-
pmtx «n £te vopp>llc»tor. v.:J5^1le»^«»-^(^^'woaM-'%e-TidTiiiiialtly affected'by a
suspension, such as those who apply restricted use pesticides infrequently,
should receive longer suspensions than applicators whose day-to-day
tLFEA Compliance/ Eat or cement 5-7 Guidance Ma**""1 1993
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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. §171.ll(c)(7); 40 C.F.R. $171.1l(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 Bequests
No explicit authority exists in F1FRA 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;
FIFKA 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 & -recall decision aus£ 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
1-evel -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 18 limited flr"* ^nnaoyton^y flv* -pnfry^f 4^1 fjftn—
gCT 10.100.
• 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.
J? 1_>KA 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;
pliance/Enforceaent 5-10 Cuiiilflnge
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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 .-?*nc+n*A 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 violative 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 th«»
- They are not registered, or are so grossly overformulated 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;
FIFRA Gmpliance/Enforceaent 5-11 qni4tnvf n»m**i 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."
FJFBA Compliance/Enforcement 3-12 Guidance My«"*i 1983
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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 violatlve product is
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 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
In cases where th« 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
Involves a first offense under the Act by any registrant, commer-
cial applicator, "for hire" applicator, wholesaler, dealer, re-
tailer, 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 .party
. specified 4n :£tae 'first category, «hoiaa« r*ccdv*d a sprier analog
or -citation 3Eor * "vtolmtltm t>f '-FIFHA.
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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
Injunctive relief. These include but are not limited to:
• The violation of a Section 6 suspension order;
• The violation of an SSDRO 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.
FIFKA GoBpllance/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 violative 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 ^examples -are «la±lar ; to ttose that vould lead the Agency to Inl-
£l*£e an.iSSBRO. Because an sSDRO«c«n be ieffected 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;
x» ;Ute .Agency jsas reason lo ^kellerve tins -M person, If Issued an SSU&O,
•0*133. nwt comply"wltb. 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
-. •• 3± Is accessary to 'dispose af productsfeeing held under -ma. SSURO
for which the responsible party has taken no corrective action and
has expressed an Intent not to take corrective action.
FIFRA Qmpllance/Enforceaent 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 toxlcity 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/Enforceaent 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 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
Triva+A «c jnwlTiH-1-ng yyiainal prnaortH-ton in circumstances HOt 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;
-.<• Jtelavful nse« x>r" -pesticides; and
• Illegal distribution of unregistered pesticides.
FlVkA Compliance/Enforcement 5-17 ~" Guidance""
-------
Chapter Five Exhibit 5-1
Efficacy Standards and Level of Action Guidance
for Disinfectants and Bodenticides
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 Related Disinfectant Products." Additionally, for both disin-
fectants and rodenticides, 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
choleraeslus, 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 falls 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 choleraeslus.
FIFRA Gompliance/Enforceaent 5-18 Guidance M«nM*T 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 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)
Perfuimance 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 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)
Perforn«"re JSfcandaxd: A -product Is de£eralaed to fall efficacy
rrr-.amm
organism.*
Level of Action: Initiation of cancellation proceedings.
Bodentlcldes
Both single dose (acute) and multiple dose rodenticides that make
claims for commensal rodents are tested for efficacy.
11 piufluct -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.
FIFEA Qmpllance/Baforceaent 5-19 Guidance Manual 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.
PIFBA 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
Barm to Human
Health
Environmental
Harm
Toxlcity—Category I pesticides,
restricted use pesticides, or
pesticides that are associated
vith chronic health effects
(mutageniclty, oncogenlclty,
teratogenlcity, 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
Hinor potential or actual harm to
the environment, neither wide-
spread nor substantial
FXFBA Compliance/Enfor
5-21
n»e Hanual 1983
-------
Chapter Five
Exhibit 5-2
Violation
Weighting
Activity
GRAVITY 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 Compliance/Enforcement
5-22
Guidance
1983
-------
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
Rodentlcldes 5-18
Exhibit 5-2: Criteria for Determining the Gravity
of a Use Violation for Purposes of
a Certification Action 5-21
FIFBA Compliance/Enforcement 5-1 Guidance Manual 1983
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Chapter Five Contents
FIFRA CoBpilasee/Baforceaemi 5-iiGuidance Manual 1983
-------
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 .atop sale * use , and .removal orders,. The Agency
Temerves 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);
--• Seminations af «»tabll*h»ent
-------
Chapter Five Introduction
Judicial actions may involve either civil or criminal proceedings. Civil
proceedings include:
• Injunctions under Section 16(c); and
• Seizures under Section I3(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.
FURA Compliance/Enforcement 5-2 Guidance Manual 1983
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Chapter Five
2 Level of Action Policy
Advertising Letters
.An advextlslng letter is a letter Issued by EPA. me 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 ^clxlae (If related to a device).
In addition, the advertising letter should request a written response from
the recipient informing the Agency of whatever action the company plans to
take in response to the concerns expressed by EPA. The Agency will take no
further action* (even when the company fails to respond to the letter)
until and unless EPA collects an official product sample with the offending
literature. At that time, EPA may issue a notice of warning or civil com-
plaint, as warranted by the circumstances.
* The Agency may, however, refer a case of unacceptable advertising to
the Federal Trade Commission for action.
FIFEA Compliance/Enforcement 5-3
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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 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 simlllar circumstances);
and
FIFRA Compliance/Enforcement 5-4 Guidance *?•""'' 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.&. 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
responsibility to submit «mmal reports. If ±fce vstablisbmeat .does not
•afenit ^sn annual : pestieliies -report "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
Tjone or "will go out of business, no longer produces pesticides, or
otherwise no longer falls under the purview of FIFRA Section 7. In such
cases the procedures for terminating establishment registration are
notification of establishment registration; subsequent reports are due by
February 1 of each year. The Agency nay, however, grant discretionary
eztentions of up to 30 days for filing a report before the report is
considered delinquent.
Compll ance/Bator cement 5-5 Guidance »«««»"« 1983
-------
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.
Sl71.ll (f)(5)(i)]« 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
-------
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 Invoicing 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 -betHeea 2 and 4 .months
: .>••; Suspension
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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 (Recordkeeplng Violation). EPA may also suspend certifications
of commercial applicators who violate restricted use pesticides record-
keeping requirements [see 40 C.F.R. $171.11(c)(7); 40 C.F.E. $171.11(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 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;
PIFRA Gcmpnance/Enforcement 5^8 Guidance ^armai 1933
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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 Tie 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
of recall is ±fa« 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 :4an-
ger i* .Ixnr.
• 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.
flfltA Compliance/Enforcement P5 " 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 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;
FIFRA. QyaTl'iat"'"*/Tt"f<>T'*'**"**Tir 5-10 Guidance tfm*"*1
-------
Chapter Five Level of Action Policy
• It can be written ao 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 nay 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 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 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;
FIRA Gmpllance/Entorceaent 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 deleterlously 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 mlsbranded, 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 Mf"1"""1 1983
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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, EPA should consider an alternative enforcement remedy
available under FIFRA.
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
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 Administrarlve Penalties
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 FIFRA
for violators In this category); or
Involves a private applicator or other person, other than any
«pr rifted 3a the •. jBaat category, .*fa> ^MX«c«l^sd/»yrlor warning
or • •'dtstlfnr^for * violation of 'FIFRA. (The prior warning or cita-
tion may have been for the same or a different FIFRA violation.)
FIFRA Compliance/Enforcement PI3 " Guidance Manual 1981
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Chapter Five Level of Action Policy
Injunctions
Section 16(c) of FIFRA gives EPA the authority to Initiate Injunctlve
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 rea 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 violative products
rather than against j^fHyiduals , :-JEEA <.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 examples are sdnilar to those tbat vonld lead the JVgency to ini-
tiste an S5TJRD. Because an SSTJKO can 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 SSURO, but the recipient of the order has
not complied with it;
.--• Hhe Agency has zeasoa to teUeve ±hmt a person, if lasoed
-------
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 Mine,
"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 EFA'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 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 as precluding crlaina 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 SSU&O;
<* Unlawful uses of pesticides; and
• Illegal distribution of unregistered pesticides.
~ FIFKA Compliance/Enforcement5-17 "" Guidance Manual 1983
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Chapter Five
Efficacy Standards and Level of Action Guidance
for Disinfectants and Rodenticldes
Efficacy standards have been developed and are being utilized by the
Agency for hospital or medical use disinfectant products and rodentl-
cides. 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 rodenticides, 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 aeruginosa* 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.
FIFRA Compliance/Enforcement 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 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)
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 -fail efficacy
. .testing .if .three ar acre of the five samples fall to destroy any
organism.*
Level of Action; Initiation of cancellation proceedings.
Rodentlcides
Both single dose (acute) and multiple dose rodenticides that make
claims for commensal rodents are tested for efficacy.
lievel TI TJTwtact 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.
FIFEA CoBpllance/Enforceaent 5-19 Guidance Manual 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
Barm
-Toxicity—Category I pesticides,
.restricted use pesticides, or
pesticides that are associated
with chronic health effects
(mutagenicity, oncogen!city,
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
trrrmnn K»a1 ».h^ «.o-t^-Koi- -serlOUS HOT
widespread
Substantial or widespread actual
harm to the environment (e.g.,
crops, water, livestock, wildlife,
or-other sensitive
,1
Substantial or widespread
potential harm to the environment
•. ..«•••
to
uvii uument , neither wide-
spread nor substantial
Co«pliance/Bnfor
5-21
Guidance
1983
-------
.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
Ho 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
FLFRA CoMpllance/Enforceaent
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, Dae or
Removal Order 6-26
FIJRA Compliance/ Enforcement 6-i Guidance Manual 1983
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Chapter Six Contents
FIFRA Oovpllance/Enforceaent 6*11 Guidance Manual 1983
-------
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. S171.11;
• 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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Introduction
Chapter Six _. _____ -
FXFM Compliance/Enforcement 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 mail, return
receipt requested.
FIFRA Compliance/Enforcement
-------
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. Notice M£ .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 Agency .ohould ^detexmlne peaaltlea according to
tiie^MVcrity of the ylnlatlaaa» and tfae ^aataaaiM t2) of ZUSa. Twjnlres ZPA-to *ne » notice 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
Ooap.La.ance/gatorci?me. nt o—4 Qnifimni** Manual 1983
-------
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 mall, return
receipt requested.
Terminations of Establishment Registrations
The regulations related to the registration of pesticide-producing
establishments, at 40 C.F.R. $167.3, 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 fails 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.
Eorceaent6-5Guidance Manual 1983
-------
Chapter Six A^-tn-fatrative 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 well as .instructions for
Tr*"ty******ft*Mrt' nf Mg*«*g**i«n. The Agency should «end the notice
"by certified mail, return receipt requested. The Agency nay 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 application .for gstahl 1 shaenf
registration, however » does not preclude the : Agency -fxarn proceeding aitb a
penalty action for failure to submit reports.
Denials, Suspensions, Modifications, or Revocations of Applicator
Certifications
to Ac rrrf1f1r«rlmi of ye«ticlde applicators (40
•C.T.TU Tart 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 ,aay »usp»nd ^ny part .or :«11 of *
:«1tfrnnr »pTDvlaia& £ar «Nheaxing /upon det«TBiltilTsg that such action is
warranted by "the public health, interest, or welfare" [40 C.F.R.
§171.11(f )(5)(i)]. The Agency may deny issuance of a certificate, or
modify or revoke an existing certificate, after providing opportunity for a
hearing .
FIFRA Compliance/Enforcement &% • 6uidance Manual 1«HET
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Chapter Six Administrative 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/EnforcementFT Guidance Hanuai
-------
Chapter Six AdnrfniBtrative 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
TOeceftvaTy). Should ^PTSCHS <*nd/or tie Segl*tr*£ion.
-------
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 mlsfemulated 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 mail the recall letter by certified vail, 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.
PIFBA Cbapliaaee/Enforceaent 6-9 Guidance Manual 1983
-------
Chapter Six Administrative Enforcement 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 violatlve product. An authorized
j 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 mail). 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
In the file «uch « 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 mail, 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
. llle.
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 fox f ^*P p^otitEcf ^n ^/T^* -cttitPm - Aff^T^-eH^* '•^M'*TM>ff j*f iffp cmn
>• .^M»pH«fti»ii *»Tl^lg». .pM A««. • w^^M-a^^m ««f *the following-.
• Obtaining product registration;
FIFRA Goapllance/Eaforce»ent 6-11 Guidance Manual 1983
-------
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 conformance 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 Gompllance/Enforceaent 6-12 Guidance Hanual 1983
-------
Chapter Six 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 Injunctlve relief
under Section 16(c).
umpJ-iance/Enxorceaent o-lJ Guidance Manna 1 1983
-------
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 Compliance/Enforcement 6-14 Guidance Manual 1983
-------
Chapter Six
Exhibit 6-2
of
(Company name)
(Address)
SubJect: (Sample number)
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Bodenticide 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. You should continue to hold the
merchandise .pending a final declaionaa to whether it ahall be admit-
ted or refused adolssion.
Pursuant to Section 17(c) of the Act, the Agency hereby affords you an
opportunity to offer such explanation as you wish for the Agency's
consideration. You should file your answer, signed by you or your
attorney, with this office within twenty (20) 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).
Bate of Importation
Consignee
Shipper/Manufacturer
Entry Mo.
-Product -Kane ( e )
Date
i. It
Port of Entry
that the product(*) »f ailed to comply -with
the provisions of the Act in that (describe violation). A copy of the
Act is enclosed for your reference.
Sincerely yours,
{Signature, name» and title)
Enclosure
FXFBA Ompllance/Enforceaent
6-15
Guidance Manual 1983
-------
Chapter Six Exhibit 6-3
Model Release Sotice
(Company name)
(Address)
Subject: (Sample number)
Gentlemen:
In connection with the enforcement of the Federal Insecticide,
Fungicide, and Rodenticide Act, as amended, 7 D.S.C. 5136, 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 vay 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
-------
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 Rodenticide 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 Kane(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
?,iola£lan(s )i
(Described violations)
The Agency hereby notifies you that it refused admission of the
merchandise. You 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, .destruc-
tion; -«f :*ne^»errh«Ttdt«e MM authorized fcy the Jet, or, If the siipaent
tau 3>een "released "to yon under bond, in any action necessary to enforce
the terms of said bond.
Sincerely yours,
«nd title)
FIFBA CovpUance/Enforceaent 6—17 Guidance Ma^ml 1983
-------
Chapter Six Exhibit 6-5
Model Botice of Warning
(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. Sl36» 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 vlth 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.
FIFRA Compliance Enforcement 6-18 Guidance Manual 1983
-------
Chapter Six Exhibit 6-6
Model lotlce of Intent to Terminate
Establishment Registration
(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 Rodentlclde Act, as amended, 7 U.S.C. $136, and 40
£.£.&. 5167.3. The Agency Intends to take this action based on your
_mi_ur« to ^submit ^reports required "by Section 7 (c) of the Act and by
40 C.F.R. S167.5.
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.
. 'Sincerel
(Signature, name, and title)
FXFRA. Cbvpllance/Enforceaent 6-19 Guidance Manual 1983
-------
Chapter Six Exhibit 6-7
Model Notice of Termination'of
Establishment Registration
(Company name)
(Address)
SubJect: (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).
You 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)
FZFEA CoBpliance/Eoforceseat 6-20 Guidance Manual 1983
-------
Chapter Six
Exhibit 6-8
Proposal for Recall Form
[ ] Formal Recall
[ ] Informal Recall
Region _ has decided to recall the product (name of product) for the
following reasons : (reasons for recall)
Heglon 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
[ ] Analytical Reports
J..J Labels
Regional Office
[ ] Scientific Review
[ j Other - Specify
(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
Registration Division
(Sign and Date)
(Sign and Date)
FIFRA Gtmpllance/Bnforceaent
6-21
Guidance Manual 1983
-------
Chapter Six Exhibit 6-9
Model Formal Recall Request in Connection with
Suspension or Cancellation
(Company name)
(Address)
Subject: (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 U.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./Ms. (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 Enfo7Geaeo.t 6-22 Guidance MatniBl 1983
-------
Chapter Six Exhibit 6-10
Formal B»«»*n Bequest in Connection
with Sample Collections
(Company name)
(Address)
SubJ ect : (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 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. coMigneeg return tills product
'to <7oor 'company;
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 ../Ms. (name) ~,
-------
Chapter Six 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
-------
Chapter Six Exhibit 6-12
Model Stop Sale, Dse, or Removal Order
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
STOP SAT.?., DSE, 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*
I136ky I hereby order ym^^ 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 Border -or «>f*nch farther txrderv as vay be Issued in connection
pesticide w "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 Ompliance/Boforceaent 6-25 Guidance Manual 1983
-------
Chapter Six »«MMt
Model Termination of Stop Sale, Use, or Removal 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)
TTFBA Coapl 1 rnr*/'ttrtfn'r'-~ifip**+ 6-26 Geidaace ifamMi 1983
-------
Chapter Seven
Administrative Enforcement Actions:
Civil Penalty Proceedings
Chapter Contents __ _ _ _ Page
1 Introduction 7-1
Consolidated .Rules of Practice (CHOP) 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 fhp -CMipl-ff "*" . ' 'T7—32
of Use 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 Prehear ing Stage 7-63
• .iatetv*noT« '«nd --AndLctiB ' ^Cur i&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
Confexcnce , , 7-7A
*Motitm for 'Accelerated Decisions and Dismissals 7-77
-------
Chapter Seven
Contents
5 Hearing Stage
Notice of Bearing and Venue
Presentation of Evidence
Preponderance of Evidence
Default Orders and Accelerated Decisions
Hearing Rules of Evidence
Objections and Rulings
Offers of Proof
Transcript of Hearing
Proposed Findings, Conclusions, and Orders
Motion To Reopen Hearing
Appeals of Interlocutory Orders or Rulings
Exhibit 7-4: Sample Default Order
Exhibit 7-5: Sample Consent Agreement and Final Order
7-81
7-81
7-81
7-82
7-82
7-83
7-86
7-87
7-87
7-88
7-89
7-90
7-92
7-95
6 Post-Hearing Stage
Appeal of Initial Decision
Final Order
Notice of Judgment
Payment of Penalty
7-97
7-97
7-99
7-100
7-100
FUSA Coapllance/Eoforceaeat
7-ii
Guidance Manual 1983
-------
Chapter Seven
1 Introduction
In most 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 the •violation Is committed knowingly, criminal prosecution
«ayvbe 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
Consolidated Rulea
-------
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. 22.27U)
FIFRA Compliance/Enforcement 7-2 Goidaaee Maaaal 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 Govpliance/Soforceaent 7-3QvMgTv^ MMMM! iq«3
-------
Chapter Seven
ELeaenta of a Violation: Administrative
Section 12 (a)(l)(A)
Any pesticide not registered under Section 3.
ELEMENTS OF THE VIOLATION
ESTABLISHING THE VIOLATION
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 Qoapliance/Enforeeaeiit
7-4
Manual 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.
Determination 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
..Bade An connection vlth its
registr&tlon..
Identification of the respon-
sible party for suspected
violation in commerce. See
"Additional Sources of Documen-
tation" (Chapter 4).
^Appropriate regional or KD
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 ~*Level of Action Policy"
(Chapter 5) and for the penalty
amount, see Appendix 6.
PXFKA Co»pli ance/Bnfo
7-5
uiance
1983
-------
Chapter Seven
Elements 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.
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 registered pesticide.
3.
Determination that the composi-
tion of a pesticide sold or
distributed In commerce differs
from the composition under which
it is registered.
Identification of the respon-
sible party for suspected
violation In commerce. See
"Additional Sources of Documen-
tation" (Chapter 4).
2. Appropriate regional or RD
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).
FIFBA Compliance/Eofori
7-6
Manama | 1983
-------
Chapter Seven
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
3.
Determination that the pesticide
has not been colored or discolored
pursuant to the provisions of
Section 25 (c)(5).
1. Identification of the respon-
sible party for suspected
violation in commerce. See
"Additional Sources of Documen-
tation" (Chapter 4).
2. Appropriate regional or BD
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).
3. Consult 40 C.F.R. $162.13 for
requirements imposed on regis-
trants to color or discolor
pesticides.
FIFKA
7-7
Manual 1983
-------
Chapter Seven
Elegants of a Violation: .Administrative
Section 12 (a)(l)(B); 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
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
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 KD
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 $ 162.10(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,
ED will review efficacy data for
the product. For the signifi-
cance of misbranding, see "Level
of Action Policy" (Chapter 5) and
for the penalty amount, see
Appendix 6.
FIFEA Otmpliance/Bnforceaent
7-8
Guidance Manual 1983
-------
Chapter Seven
Elements of a Violation: Administrative
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;
as to the safety of
-------
Chapter Seven
Eleaents 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 a
package or other container or wrapping which did not conform to the
standards established by Section 25(c)(3).
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.
3.
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.
FZFBA Oompllaace/Eaf orceaent
7-10
Guidance Manual 1983
-------
Chapter Seven
Elements of a Violation: Administrative
Sections 12(a)(l)(B); 2(q)(l)(C)
Any pesticide or device that was misbranded In that It was an Imitation
of, or was offered for sale under the name of, another pesticide or
device.
ELEMENTS OF THE VIOLATION
ESTABLISHING THE VIOLATION
1.
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 pesti-
cide or device was misbranded
JA £hat It HaB offered for sale
under £he ,aame-sof another pesti-
cide or device, i.e.:
• A manufacturer duplicated
the composition of another
pesticide and offered it for
sale under the name of that
pesticide.
1. 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 -not
"the -producer registered to
manufacture that product. See
"Scientific Review" under
"Further Processing of the ID
Jacket—Enforcement Case Review"
(Chapter 4).
FIFRA Coapl1ance/Bnforce»ent
7-11
Guidance
1983
-------
Chapter Seven
Elements of a Violation; Administrative
Sections 12(a)(l)(E); 2(q)(l)(D)
Any pesticide or device that was mlsbranded 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
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).
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.
1162.10(e) for requirements. For
the significance of the omission,
•ee "Level of Action Policy"
(Chapter 5) and for the penalty
amount, see Appendix 6.
FIFBA Gmpliance/Enfor
7-12
Manual 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 conspicuousness 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 THE VIOLATION
ESTABLISHING THE VIOLATION
1.
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).
Determination that the label or
labeling of the .pesticide or
device does not conform to the
format required by the
product's regis tration.
2.
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 JU) .per-
.'••oixDel: xwlew-tprt>dnct labeling to
determine conformance with the
label accepted In conjunction
with the registration. Consult
40 C.F.&. Sl62.10(a)(2) for
"Prominence and Legibility"
requirements. For the signifi-
cance of the discrepancies, see
"Level *>f ^Action Policy" (Chapter
5) und >£or the i»enalty amount,
*ee Appendix 6.
FIFBA Gmpllance/Bnfor
7-13
Guidance Manual 1983
-------
Chapter Seven
Eleaents of a Violation: Administrative
Sections 12(a)(l)(K); 2(q)(l)(P)
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 TEE 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.
FIFRA Ctmpliance/Enforeesent
7=14
Guidance Manual 1983
-------
Chapter Seven
EL
ts of a Violation: Administrative
Sections 12(a)(l)(B); 2(q)(l)(C)
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
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
- -trf' t:l*e • Act.
and/or Implementing regula-
tions.
1. Identification of the responsible
party for suspected violation in
commerce. See "Additional
Sources of Documentation"
(Chapter 4).
2. 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).
3. Appropriate regional or RD j>er-
Tevlew product ?«t«a]i«g 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(h) for
requirements. For the signifi-
cance of the discrepancies.* *ee
•Level of Action Policy" (Chapter
5) and for the penalty amount,
see Appendix 6.
^ anff
7-15
Guidance Manual 1983
-------
Chapter Seven
Elements of a Violation: Administrative
Sections 12(a)(l)(K); 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.
FZFRA Compliance/fioforceaent
7-16
Guidance Manual 1983
-------
Chapter Seven
ELeaents of a Violation: Administrative
Sections 12(a)(l)(K); 2(q)(2)(A)
Any pesticide that was mlsbranded 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
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
nt In £he .appropriate
position except where i
• The size or form 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.
Identification of the responsible
party for suspected violation in
commerce. See "Additional
Sources of Documentation"
(Chapter 4).
2. Appropriate regional or ED 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
laheH-ng to determine whether the
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 *be
penalty amount, see Appendix 6.
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.
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.
Identification of the responsible
party for suspected violation in
commerce. See "Additional
Sources of Documentation"
(Chapter 4).
2. 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 Review"
(Chapter 4).
3. 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. Sl62.10(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.
PIFBA
ice/Enforcevent
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.
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
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 4).
Appropriate regional or JU>
personnel review product ly
pesticide is sold;
The net weight or measure of
the contents, unless an
exemption is granted by the
Administrator; and
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 for the
•«•*• Appendix 6.
- ie> -.'• 'Jbe -;:xegli> trarion..
assigned to the pesticide
and the use classification.
7-19
Guidance
1983
-------
Chapter Seven
Elements of a Violation: Administrative
Sections 12(a)(l)(B); 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 onlssion, see
"Level of Action Policy" (Chapter
5) and for the penalty amount,
see Appendix 6.
FIFRA Compliance/Eofor
7-20
Guidance
1983
-------
Chapter Seven
Elements of a Violation: Adolnlstratli
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.
3.
Determination that the product
was adulterated In a manner
described by the Act.
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 o£ the ID
Jacket—•Enforcenent Case J&eview"
(Chapter 4).
3. Appropriate regional or RD per-
sonnel review chemistry labora-
tory tests to determine whether
the product composition conforms
to the composition accepted in
HC f-f-ff" '"fit l*$1 'fHf J^TI>1'^Tf^"^ **"
.registration, fiee
"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
«oli«T" ^Chapter 5) tod for the
penalty warrant, see Appendix 6.
FIPBA Ocmpllance/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. Beview 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.
FIFBA Coapliaace/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
- Experimental permit
immber (1^ 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, oevlce** active
Ingredients used in pro-
ducing pesticides.
— Brand name/common or
chemical "amo
- Hame and address of
shipper
- .. .-—-.--vJhHBB'flof transporter
..•-,- -—•-::;B«:e received
- Quantities received
• Records regarding shipment
of pesticides, devices, and
active ingredients.
chemical name
- Name and address of
consignee
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.
FI7KA Coapllance/Enfo
7-23
G
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.)
FIFBA Qmpliance/Bnfori
7-24
ffrm««1 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
— .lest 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 Qmpliance/Enfo
7-25
uidance
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.
FIFRA Compliance/Enforcement
7-26
Guidance Basaal 1983
-------
Chapter Seven
ELenents 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 Ocmpliance/Enforceaent
7-27
ui
1983
-------
Chapter Seven
Elements of a Violation: Administrative
Section 12(a)(2)(C)
A person gave a guaranty or undertaking provided for in Section 12(b)
that was false in any particular.
ELEMENTS OF THE VIOLATION
ESTABLISHING THE VIOLATION
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 Oompllance/Enfor
7-28
uian
1983
-------
Chapter Seven
Elements 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 vas 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
•hould
• 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.
•'liar .^significance of the alleged
disclosure, see "Level of Action
Policy" (Chapter 5) and for the
penalty amount, see Appendix 6.
FIFBA Compliance/Enforceaent
7-29
Guidance *?••««• "I 1983
-------
Chapter Seven
Elements of a Violation: AdadLnlstrative
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
Determination that the product
Is a pesticide registered for
restricted use.
Determination that a
restricted use pesticide was
advertised for sale without its
appropriate use classifi-
cation.
1. 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).
2. 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 Qmpllance/Bnforcesent
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
•Aeview" mder "Further 'Processing
'•t»f the TD 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 Covpllance/Enforceaent
7-31
Guidance
1983
-------
Chapter Seven
Elements 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 ED 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 Compliance/Enfor
7-32
Guidance
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
Determination that •'pesticide is
under an experimental use
permit.
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 Compliance/Enfor
7-33
Guidance Manual 1983
-------
Chapter Seven
Elegants 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 (SSDRO) 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).
FIFEA GoBpllance/fiiforceaent
7-34
Guidance
1983
-------
Chapter Seven
Elements of a Violation: Adainietratlve
Section 12(a)(2)(J)
A person violated a suspension order Issued under Section 6.
ELEMENTS OF THE VIOLATION
ESTABLISHING THE VIOLATION
1* Determination that the product
has had its registration
suspended by order of the
Admlnis trator.
2. Respondent (person) distri-
buted, sold, offered for sale,
held for sale, shipped,
received and Xbrol&g «o
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 5) Aid lor the
penalty amount, see Appendix 6.
FIFRA Compliance/Enforcement
7-35
Guidance Manual 1983
-------
Chapter Seven
Eleaents of a Violation; Administrative
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.
Appropriate PTSCMS and/or ED
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).
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.
FXFBA Co«pli«nce/Knforceaent
7-36
Guidance
-------
Chapter Seven
ELeaents of a Violation: Administrative
Sections 12(a)(2)(L); 7(a)
A person violated Section 7 by failing to register his or her producing
establishments.
ELEMENTS OF THE VIOLATION
ESTABLISHING THE VIOLATION
Determination that a pesticide,
active Ingredient of a pesti-
cide, or device was produced
(see definition, Section 2(w)
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.
FIFKA Goapliance/Boforcevent
7-37
Guidance
1983
-------
Chapter Seven
Elements 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. $167.5 for
requirements. For the
significance of the violation,
see "Level of Action Policy"
(Chapter 5) and for the penalty
amount, see Appendix 6.
FIFBA Compliance/Enforcement
7-38
Guidance Manual
-------
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
JOT the penalty amount, Bee
Appendix 6.
FIFBA Goapllance/Enfo
7-39
Guidance Manual 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 CbBpllance/Boforceaent
7-40
Guidance Manual 1983
-------
Chapter Seven
El
its of a Violation: Administrative
Section 12(a)(2)(H)
Any 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 .'Pnt VIOLATION
ESTABLISHING THE VIOLATION
1. Determination of person's
status and failure to file the
required report.
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.
FIFMA Compliance/Boforceaent
7-41
Guidance Manual 1983
-------
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.
IXFBA. Compliance/Enfo:
7-42
Mrnmutl 1983
-------
Chapter Seven
Elements 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
Determination that the test
subject was not fully Informed
of:
• The nature and purpose of
the test; and
• Any foreseeable physical
and .rental health conse-
quences .
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.
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.
FIFRA Gompliance/&ifor<
7-43
1983
-------
Chapter Seven
of a. Violations Administrative
7-44
-------
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 £he -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-hlre" 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
,«f the ACt« C^** J»^«w .awm-t^l nr
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
Xntqim£lyv the diatrlintlan of ;p>«tlclde« ar jterices Jn i iimai ri i 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 Grapllance/Bnforcement 7-45 Guidance Manual 1983
-------
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
Compliance/Enforcement"7-A6
-------
Chapter Seven Complaint Preparation and
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 PTSCMS in the following instances:
- Routine misuse cases (verbal) ,
- Exceptional misuse cases of first Impression or of unusual
national Importance (written), and
-- •• --ffff ^l^m*"** ir^|w*tirtna o.f more .than .-40 percent of .the .penalty
anotmt 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.
f'i>y':'*T>3r . y««**"»^f <*y riyl-ygg*'^ to .him or
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
*Mvl8l0nvDlTec±CK" level.
7-47
-------
Chapter Seven Cowplai"t 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 nonprlvlleged evidence and,
falling 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. Aa applied to
violators subject to Section 14(a)(l) of the Act and "for hire"
applicators under Section 14(a)(2), sice 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 Ffr11***' 1983
-------
Chapter Seven Complaint Preparation and FUlag
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
f y io1 f j •****+• &ff f ft
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
!.*-*«. Mo. IX-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,
'** '*** M* VI J
Act, and
- Any evidence of good faith.
cpapi i ance/mrorLf mt1 nt /-*»> Guidance Manual
-------
Chapter Seven Complaint Pr*o«r*tlon mod 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 Beaulleu 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.) Not 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. Hos. 88176, 88468, 90943,
Initial Decision by ALJ Bernard D. Levinson, May 31, 1974; and In He;
Chapman Chemical Company, I.D. No. 104559, amended Final Order by B* A.
Jack E. Ravan, July 29, 1975. See also Blockburger v. Onlted States,
284 U.S. 299 (1932); and Tesciona v. Banter, 151 F.2d 589 (10th CLr.
1945).
FIFRA CoBpllance/Enforceaent7-50
-------
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 ^a 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.
Complaint 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
• Hake 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 Matter of Hawk Industries, Inc., I.F.&&. Docket No.
II-120-C, Issued by ALJ Bernard D. Levlnson, December 21, 1976.
"The TioBbers to The l;«ft 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 Ckmpllance/Enforceaent7-5?
-------
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. H-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.
FIFIA Covpllance/Enxorceaent 7-52 Guidance Manual 1983,
-------
Chapter Seven Complaint Preparation and Filing
Jurisdlctional Authority (C)
The complaint must contain a statement of Jurlsdlctlonal 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
dequate response can be 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 CHOP. For Instance, even though the
respondent may have been present when certain facts were ascertained, .those
' 'fwpTT' mirf* • ****'n •' ^* i;'f'*M**'gi^*^ffjp';-*!'B**ff'» '•-'jJi^'-TMppmd^nff ywl t*fr* Presiding
Officer of their legal significance.
22.14U)(3)
Citation of Legal Requirements Violated (E)
Tho fit-of Inn &£ ffrf J****f j Tiller rjrffYJgf-ftll -fff f Hf ttttntf
For example, if the complaint alleges a violation of Section 12 of FIFRA,
the specific subsection under Section 12 that is the basis of the violation
must be cited [e.g., misuse of pesticide 12(a)(2)(6)].
22.14(a)(2)
FIFBA Ompllance/Riforcement 7-r ' Goldanrj* M«m*i
-------
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 FIFRA. 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
22.14UX5)
• Specifically identify the proposed penalty amount (G).
22.14(a)(4)
Right to Request a Hearing (H)
The respondent must be informed of the right to request a hearing
concerning any material fact contained in the complaint or concerning the
appropriateness of the amount of the proposed penalty. The respondent
should be referred to a copy of the CROP, which is attached to the
complaint, for information concerning the request for a hearing and the
consequences of failing to request a hearing.
22.14
-------
Chapter Seven Co^pia-JTH- 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 ••"frla-i^t
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 mall, return receipt
requested .
officer, partner, managing or general agent, or any other person authorized
by appointment or by Federal or State lav to receive service of process.
The return receipt establishes that the complaint was received on a
particular date.
* retained
-the Agency. If no return receipt is obtained, another letter should be
sent. If no receipt is again obtained, personal service may be necessary.
FJLFKA oomp n ance/ miorcemeut /-^^ Goldance M*™MI 1983
-------
Chapter Seven Complaint Preparation and Filing
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
-------
Chapter Seven
Exhibit 7-1
Sample Complaint
UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
BEFORE THE ADMINISTRATOR
In re:
(A)
Flretog 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. 51361] of the Federal Insecticide,
Fungicide, and Rodentlclde 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 Flretog 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. Mlsbranded In that the label stated, in part:
•* * *
MOLD
STOP
* * *
ACTIVE INGREDIENTS: 25Z Propionic Acid
* * *-
FIFRA Gtmpliance/Kxforceaent
7-57
Guidance Mnrnrtl 1983
-------
Chapter Seven E»hibit7-l
whereas, when tested, the product did not contain 25Z Proplonlc Acid.
[FIFRA Sl2(a)(l)(E), 7 D.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
Sl2(a)(l)(E), 7 U.S.C. §136j(a)(l)(E); FIFRA §2(c)(l), 7 U.S.C.
Sl36(c)(l)]
(When analyzed, the product was found to contain only 13.81Z and
14.23Z Propionlc 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. S1361(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. Reg. 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. ], 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 Buidling, Boston, Massachusetts 02203.
FIFRA Compllance/Bnforceaent 7-58 anij^** Manual 1983
-------
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
-• result of infernal 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.rt*'"'*/T*iftrrcrac nt 7-59 flnfdjmoo jtm^nmi 1983
-------
Chapter Seven Kxfalblt 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
Flretog 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. §22.01 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. lou 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 f>raj>i <«n«"*»/BnfQT^jag* at 7—60 Guidance »fa»*w»i 1983
-------
Chapter Seven __ Exhibit 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)
FIFRA CbBpliance/Enforceaent 7-61 Guidance Manual 1983
-------
Chapter Seven Exhibits
OaamU gmcmfKnfnf
-------
Chapter Seven
4 Prehearing Stage
Intervenors and Amlcus Curiae
Individual nay 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 -action to become ^n dmtervenor Is ordl-narily made before the first
T>rei«aTtng conference. -^However, the -motion may be made after that tine 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
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 amicus briefs in all subsequent briefings during the
proceeding and is served with copies of all documents relating to such
22.1X4)
fTnmpHimrr/ITnfnrccmcnt 7-
-------
Chapter Sevenpr*»iMwH«E Stage
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(«)(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 to 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 to
the parties; and
• Copies of direct correspondence from the parties to the Presiding
Officer.
FIJTMA pMir / sazorcesemc /~OH Guidance
-------
Chapter Seven Prchearlng Stage
Copies of the above documents must 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 *tne 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
• 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 bears the jiane* .address* and telephone number 4>f-the person
±Hlag the riru isMiit 3f ^± Is the initial docasent filed fay that
person. Any changes in this information must be sent to the
Hearing Clerk, Presiding Officer, and all other parties to the
uDmp.Li.ance/iair or cement /-to Guidance Mr*****' 1983
-------
Chapter Seven pr»h*»»T-i«E stage
proceeding. If a party fails to provide or, vhen 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 amicus 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.
22.09(a)
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) Che merits
of the proceeding with individuals or their representatives who have an
interest In the proceeding.
22.08
Although ej_ 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.
ocapiiance/Bazogcaacat /-bo Guidance
-------
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:
* An Agency offIclal who performs; 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 -must 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.
22.15U)
Procedural Considerations
Before the answer is filed, all motions 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.
ompxrance/BQXorcemenc 7-o7 Guidance tlsmifl 1983
-------
Chapter Seven Prehearlng 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)
FIFBA Compliance/Enforcewent7-68 Guidance Manual 1983
-------
Chapter Seven Prehearing 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
-------
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 nay be used in
preheating conferences at the discretion of the Presiding Officer, most
notions 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
Bearing Clerk within 10 days after service of such motion, except in the
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(b), 22.17(a)
If a response is not filed within the time specified by Section 22.07 of
the CROP, any objection to the motion is considered waived, and the motion
may be granted without further argument.
22.16(b)
The Administrator, Regional Administrator, and Presiding Officer, as
appropriate, may set a shorter time than 10 days for the response, and may
also permit oral argument concerning motions.
22.16(b)
Examples of Prehearing Motions
The following types of motions might be made during the prehearlng stage of
the proceeding. Some motions must be made during the prehearlng stage, but
most may be made at other stages of the proceeding as well:
• Motion for default for failure to file a timely answer;
22.17UX1)
• Motion to intervene;
22.11(a)
• Motion to file amlcus curlae brief;
22.11(d)
FIFRA Gsspliafflce/Eoforeeaaat 7-70 Guidance Manual 1983
-------
Chapter Seven Pr**"""-«rg 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). 22.12H >> j ^ 7— 4)~» T**0 action ft**- Amf^ni t-
an all fmxtlM* mad
requirements specified by Section 22.05 of the CROP.
The alleged defaulting party has 20 days from service of the motion for
default to reply to the motion.
uomp-Liance/mxorceaenc /-/i Goldance «*•«**•• 1983
-------
Chapter Seven pr~h-*r4yg 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
-------
Chapter Seven Prehpnrlng Stage
When the Administrator issues a final order upon default against the
complf'nant, 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
±8 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 « «ett2«aent Is reached by +the parties, -they vast 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)
..M_» signature: of :«ll;partles or ttedx representatives In the
proceeding (e.g., complainant, respondent, and any Intervenors);
A statement In which the respondent admits that the Agency has
jurisdictional 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.
FIFRA Oompllance/Enf ori
-------
Chapter Seven pr*»h««^«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 take
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 Begional 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.
i
The proposed consent order must be prepared for the Begional
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.
Prehearlng Conference
When a hearing is ordered, the Presiding Officer also convenes a prehearlng
conference, unless it appears unnecessary. Prehearlng 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 prehearlng conference may Involve:
22.19(a)
• Settling the case;
FIFKA Compliance/m±or cement 7-74 ani+fiun* Manual 19B3
-------
Chapter Seven Prcbearlng 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 all 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
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 SB .a ...reasonable ,he3 iff £hat «the. ^nature of. the documentary or
^physical evidence would pexaittbe 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 Che Presiding Officer.
FIFKA Compliance/Hotorcement 7-75 Guidance Manual 1983
-------
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 prehearing 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 Prehearing 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 prehearing conference that
relate to settlements, a transcript of the prehearing 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 Coapl 1 mcr/Eaforcement 7-76
-------
Chapter Seven Prehearlng 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 action by the respondent or complainant.. The 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 lav. "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
^gom^^wiitly» tfce
<)f^lc«T most Decide a partlcolar 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
motion—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.
uMpiunce/Boxorcement /-// ani^rnnr^ i**nn»i 1983
-------
Chapter Seven _^___ Pr**«»fir1n£ Stage
Pacts. 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 law. 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 counteraffidavits 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 prima 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 CoMpllance/Enforcement 7-78 Goldamee ffriwMM 1983
-------
Chapter Seven Frehearing 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
an jjnt^iT'l
22.2O(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 Compliance/Enforcement 7-79
-------
Chapter Seven ^ _ ^ pr»iM*«T*Qg Stage
FIF2A Compliance/Enforcement7-80 '. - Guidance Mmual 1983
-------
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 Law 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.
22.35
-------
Chapter Seven n«w*«g stage
"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 fade
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.
FIFRA Compliance/Enforcement 7-82 Guidance Manual 1993
-------
Chapter Seven Bp*rf"g 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.
22.2U)
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)
Bnl**» otherwise permitted by the Presiding Officer ,«titdi a 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
3 ".ff-'$r*r- '•'tffiiKM'iy*f¥iHv"*'*y:^f*^^^^f*!*******••*^-';iffffH •^^"TWfftiiPTi by a
-»
-------
Chapter Seven •»«»•< «g 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)
-------
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 sane 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.
Evld., an affidavit may be admitted Into evidence in lieu of oral
testimony. Under Rule 80A(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
If szblblts are Introduced, the original and one copy vast be filed -with
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
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 aponte or upon
notion by one of the parties.
22.22(f )
201
that -«re. sot smbject -to reasonable dispute -and £hat ares
Generally known within the territorial jurisdiction of the
proceeding; or
JrmtA rnnpl 1 nnrr/ rmrnrrf ar nl 7-85 Guidance nairir*1 1983
-------
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.)
FIFRA Compliance/Enforcement 7-86 Quida"*** Manual 1983
-------
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.
22.29U)
Offers of Proof
If evidence is found immaterial, Irrelevant, etc. and cannot be Introduced,
the party; seeking to introduce it may not only object to its exclusion, but
may also make an offer of proof. An offer of proof places the evidence
into the official record, and the Administrator on appeal can use such
evidence to reopen the hearing. This offer consists of:
• One copy of the documentary or physical evidence; or
• A brief written summary, if the evidence is testamentary.
Such off«rs of proof^arejnot'mandatory, and the Tight to appeal the
exclusion of evidence is preserved under Section 22.23(a). Nonetheless,
offers of proof should generally be made whenever evidence is excluded.
22.23(b)
transcript of Hearing _
A hearing must be transcribed verbatim, and the reporter must send the
original and copies of the.* transcript to -the Regional Hearing Clerk for
filing* A copy .aust also be sent to the Presiding Officer^ The Begional
Hearing Clerk must notify all parties of the availability of the transcript
and permit them to obtain a copy upon payment of a reproduction fee.
Payment may be waived if a party can show that the cost is unduly
burdensome. A certificate of service should accompany each copy of the
transcript. Persons not a party to the proceeding may receive a copy of
the transcript (except for confidential portions of the transcript) upon
payment of a reproduction fee.
,22.25
The transcript of the hearing is an important document because:
• Many objections and motions made during the hearing are oral and
are thus reflected only in the transcript; and
• The transcript is used by the parties to draft the proposed
«Tsbmltte€ ^o the Presiding Dff leer lor consideration In issuing the
initial decision.
umpiiance/Bnxorcement 7-87 Guidance fl"*1***1 1983
-------
Chapter Seven Hiring 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;
• Reasons for those findings and conclusions;
• Recommended civil penalty; and
• Proposed final order.
oamp 11 attce/ aarorc*afmt /-oo j^idaace iftrnffrnj. 1983
-------
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 FIFBA, 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 FIPRA [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.
Challenge 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 .review; .of., tfr»..f «<«;.a raotlon to reopen :3tte 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 must 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
requlTenentg -for trobaittlng ^documents
22.28(a)
FIFBA Oompliance/Enxorceaent 7-89 Guidance Manual 1983
-------
Chapter Seven n*mT^«g Stage
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
prehearing 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 must 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
us«pn apoe/ Bnzorceasnt /-=9U Guidance nfiTniii 1983
-------
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.. This motion mist 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 Administrator
If the Presiding Officer certifies the interlocutory appeal, the
: Administrator may?
22.2t(c)
• Deny the certification as improvidently granted;
• Take no action within 30 days and thereby dismiss the
certification; or
• Grant the certification, review the interlocutory appeal, and grant
or deny the appeal on its merits.
Ordinarily, the interlocutory appeal will be .decided on the basis of the
fry t-ho . py»o<^Hr>g ,-.0f£iCflX* . ..Ti^ • ^jm'* ^"f 1><'*'> t^T TlffT '
.allow farther -briefs and oral argument
22.29(c)
Request for Stay
The motion for Interlocutory appeal may include a request for stay of the
proceeding pending the Administrator's decision on the certification and
ta> j^Btrify -gwrnting tne stay. Tf the "Presiding Officer
grants a request for stay of over 30 days, it must be separately approved
by the Administrator.
22.29•!*? ***»*"*/Fr*-ffrrrmrnt7-91
-------
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, B.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. §136 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. Sl361(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.
tl36j(a)(l)(A)]. (A copy of the complaint is annexed hereto as
Attachment A.)
7-92
uidance
1983
-------
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
trf the registration requirement. Accordingly, the proposed penalty was
assessed at $2,300. Furthermore, based on a comparison of respondent's
gross gnn\»«l 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 requirement 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
ttzrxixant to £ne 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
of 'Bf rTlnn 2(Q of 7IF2A* [7
) , 136(t)1
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 *a-Mapnnri«nt Ja« eft«rlrT«d tae fact* -alleged In the
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
F1FKA Oaapliance/Bnforcement 7-93 Guidance Manual 1983
-------
Chapter Seven
Exhibit 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 D.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 mall
to the Pesticides Bearing 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 14(a)(5) of FIFRA [7 U.S.C. Sl361(a)(5)] for
recovery by appropriate action In United States District Court.
AND NOW, THIS DAY OF October 4, 1983 the foregoing order is hereby issued
under the authority of the Federal Insecticide, Fungicide, and Rodenti-
cide Act, as amended, and the Consolidated Rules of Practice adopted
pursuant thereto. [7 U.S.C. §1361(a)(l)-(4); 40 C.F.R. S22.01 e't seq.]
Regional Administrator
Qpapl
-------
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, B.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 I4(a) of the Federal Insecticide, Fungicide, and
Rodenticide Act,, as amended* ;[7 D.S-C. J136 et seq. (hereinafter
FIFRA).J 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 jurisdictional 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. - Sespondent 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
;xespect trc> -'yr^^* "MJTwTl >1 • J^ ^^gj^i *?*i 'noted
Conclusions of Law
By reason of the facts set forth in the "Findings of Fact," It is
concluded that respondent has violated Sectlaat*) . . of J3ZRA.
Respondent hereby consents to the issuance of the following order. The
(title of the Regional Office) EPA Region _ hereby recommends that
the Regional Administrator issue the following order:
FIFRA CoBpll
/Enf on
7-95
Gnldi
Manual 1983
-------
Chapter Seven ' Ezfalblt 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, aa 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 Coap1 \ •"'••/E^o^^ment 7-96 'Vtf'in*'"* MMM"! 1983
-------
Chapter Seven
6 Post-Hearing Stage
Appeal of Initial Decision
Jurisdiction of Ad«d «
-------
Chapter Seven Po8t-««»«»^-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. Aa 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)
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)
7-98 Gotdmf* Manual 1§53
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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 , 'cnodUEy » or .-.'Stet ftidf all or sane ->of the
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
--£hjuV thp Adain.lsf rator
Motion To Reconsider and Stay Request
A party nay file a notion 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
rrors. the aotianwTvjaso l-nrlndr « xmyuuu. :tfaat the fiaal order
%e -«ta7ed pending * "revolution 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
FIFMA nrmi>1lnnrr/lTnTnrrrmcnt 7-99 aniAm^t** yimwmml 1983
-------
Chapter Seven Po8t-H«a*-t«g 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)
FIF1A GyBplisace/Eofocee^at 7-100 Qff+4*™"* Mmmai 1983
-------
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
^Exhibit S-as Model Civil Litigation ieport
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
;for •
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
: -8— '25
FIFKA Go^llance/Enforceaent 8-i i^ti^f^^^ Mnraal 1983
-------
Chapter Eight Contents
5 In Rein (Seizure) Actions 8-27
Statutory Authority 8-27
Enforcement Criteria 8-27
In 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
uompxiance/Enforcement 8-11 Guidance Hanuax 1983
-------
Chapter Eight
1 Introduction
Under FIFSA, regulatory remedies are Initially and primarily bandied .
.through %the JIM .of administrative actions. However, In those Instances
vncre EPA ,±« unable to obtain ^compliance with administrative actions, the
Act authorizes EPA to seek relief through civil court injunctlve and in rem
(seizure) proceedings.
An inj unction 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 acts .against things xather than
. **<« r*ni<* "f-g • ^ff** ^T^^n against
property and has for Its object the disposition of the property.
map11mrr/imrnrrrarnr o-i Guidance Iff""*' 1983
-------
Chapter Eight Introduction
FIFSA Gcmpliance/Baforceaent 8-2 gyt«i««Mi Manual 1983
-------
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*
**>». ~p*1-4+4 BMT- OT .plaintiff ±O make
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.
uompnance/ aororr g mt. ut o-J Guidance **»«ii»i 1983
-------
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 Hem (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 iamediate 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.")
-------
Chapter Eight
3 Procedures for Filing Actions
Bequests for FIFBA civil court actions are referred to the Department of
Justice or .*they appropriate United States Attorneys Of f ice by .the Associate
Administrator for OLEC (or the Associate Administrator's designee) .* In
most instances, the Regional Office will initiate the request for an
injunction or an In rem action and will designate the lead Agency
attorney.** The Tead 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,
lncl iitip *
- 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.
oompi.ianc«vigirorcffm
-------
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 case 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
designees) 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);
KJJKKA Unpllance/Enforceaent 8-6 Guidance Manual 198?
-------
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).
oompxxance/ mtor ccaaut B-7 Guidance M^MMI 1983
-------
Chapter Eight Exhibit 8-1
Model Civil Litigation Beport 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 Beport 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-FIFBA violations. For
example, since FIFBA referrals involve only requests for Injunctlve
or in rem relief, civil penalties would not need to be discussed in
Section VII of the report (Belief Requested).
1983
-------
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. Belief Requested Page
A. Preliminary Injunction Page
B. Standards To Be Met Page
C. Compliance Schedule Page
D. Stipulated Contempt Fines Page
'•'•*. "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 ftLth the. Case ;Ibge
IX. Litigation Strategy Page
A. Need for Preliminary Injunction Page
FIFBA Cb*pllance/Enforce*ent 8-9 O«*d«neg M^n^il 1983
-------
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 memos, regulations, interpretations
Body of the Report
I. Information Identifying the Defendant(s)
A. Legal name of company
£. 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
G. 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.
FIFBA anmll*n
-------
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. Fpr
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 -will also be developed later In paragraph
III. Statutory Authority
A. Present the substantive requirements of the law and
applicable regulations. Reference all federal statutes by
U.S.C. citation- as aell ^ 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.,
1 •'ll'm1 '\
' • • • •• J
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
Describe the violating corporation and the particular
division or facility in question. Any interesting corporate
Interrelationships or subsidiaries should be noted.
FIF1A Gbvpllance/Bfeforeement 8-11 ^^limcf Manual 1983
-------
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.
FTFRA
-------
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 atteapts* to exact compliance or lapose 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
violation ander aacn statute involved.
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,
. •4xcept vbere • ,l£ Is: txn> >.?*6l38KfcBDas Xin which case •<«•** •••tp 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.
iwailahl* by
dlscovery, indlcate:
1. The type of evidence anticipated;
FIF1A CoBpllance/Enforceaent 8-13 Guidance Manual 1983
-------
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(G).
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 Manual 1983
-------
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 EFA'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 well as credits considered and/or allowed
for other similar ^violators (Including municipal POTSs).
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.
KXX1* ••^"f ^yfrpyf^d Issues ~
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-
tiff
litigation.
2. Outline factual issues.
B. Equitable arguments by the violator.
J£PA. delay .in jafnmv\g*t'-t **£',;• f •*A»I*-»~~-' <.«»«-«n-a^-rm of
-otner
facilities; emission standard to be revised; inability to
finance; economic constraints, etc.)
FIFSA Compllance/biforcement 8-15 &.
-------
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
Gavpllaace/BnfoceeMent 8-16 Guidance Hair***"8 1983
-------
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£« ^are %«eaexmlly .reluc^nt *o 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
-••— ' "thr
The Agency has, In fact, already diligently exercised all
appropriate administrative remedies, yet the violation continues
unabated. For FIFRA, this would Include remedies such as atop
sale, use, or removal orders (SSUROs), negotiations, hearings,
fines, etc., which fall to prevent or stop the violation; and
y >inj«ry» •'• Jaas^ ' *gr 4tem«g« 3HH anesnlt if relief la not
granted. "Irreparable" means that the damage cannot be undone once
it takes place.
firm*. QDmpjaance/Bnzorcement 8—17 Guidance Manual 1983
-------
Chapter Eight Injonctlve 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. This
doctrine has been applied to violations of the Federal Food, Drug, and
Cosmetics Act [U.S. v. Ptapulse Corp. of America, 457 F.2d 25 (2nd Cir.
1972)]. It is reasonable to expect chat 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
Injunctive 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 Injunctlve Relief
1. Determine the Necessity for Injunctlve Relief
• Regional Initiation. The Regions generally make the initial
determination that an injunction is necessary to restrain
umpxiance/Bixorcement 8-18 Guidance '•y**"*1 19B3
-------
Chapter Eight Injunctlve Actions
violations of FIFRA or to prevent barm 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 PTSCHS 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 -OT '••yg'ri'^*'*^ '-w^pi g"* •***•- •**•**• •< •!•* -ml 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)
<.a shown hy spf rifle fwff fhgf
•ill occsir jmfozie the adverse paxty can :te iaexrd mad (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 -be filed.
When a TRO is granted without notice (i.e.,. ex parte) , the motion
for a preliminary Injunction must be set for~nearing at the
earliest possible time. The party who obtained the TRO must then
proceed with the application for a preliminary Injunction and if
the party does not do so, the TRO will be dissolved by the court.
If a defendant moves to modify or dissolve a TRO, there must be a
'"•^H^HHE3l^B^F tjfl^B>l
(^••i^BlMMVM^Q •^^•••^^
the "hearing
Ooapllanre/iattorcrapnt 8-19 Rni^n^^o Manual 1983
-------
Chapter Eight Injunctlve 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 injunctlve 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 (Each!bit 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
oTstrict 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 «ay 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. In 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.
uompjoance/Enforcement o-zu Guidance
-------
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 Injunctive 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 Tesponsibll-
• 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; qr
. . * Accept the ^eni^l «ndpur«Me other l«gal -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.
flfEA. Compliance/Boxorcement 8-21
-------
Chapter Eight Exhibit 8-2
Model Motion for Temporary teatraining Order
United States District Court
District of
(Title of Action) Civil Action No.
Motion for Temporary Bestraining
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 beard In opposition [*(A) 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
* (1)»(3),(4) - These statements are optional depending upon whether or
not the defendant or his attorney receives advance
notice of the request for a TRO.
* (2) - The victim of the alleged injury can be best determined
from the actual facts of the case at hand.
FIFBA Cbmplia&ce/&aforcesant 8—22 guidance MB^II^I 1933
-------
Chapter Eight Btfalbit 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:
CD TtalesB restrained by this -wrart 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
on/3 -t-ryopflT-ahlo -tnjui-y +n £he plaintiff.
(Signature of U.S. Attorney)
United States Attorney for the
Date
FUFKA CovDllance/Bnforceaent 8-23 Guidance n««m^i 1983
-------
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 Mo.
Affidavit in Support of Motion for
Preliminary Injunction
(Kane 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 aeq.].
(3) [Statement of facts to support the motion].
(Signature of Affiant)
Tot
gna
her
than EPA attorney)
Subscribed and sworn to and before me at (City and State)
this day of , 19 .
(Signature of Attesting Official)
(ot
gna
her
than EPA attorney)
FIEBA Gasp]
5/Eufor
8-24
lirnnnat 1983
-------
Chapter Eight Egfalblt 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"o"f the
defendant) is unlawful and no additional evidence could alter that
result.
[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 Jl+S. -Attorney
Jtaited States- Attorney ,for the
District of
Date
FIFRA Coapliance/Enforceaent 8-25 GniA»n^~ n^n^ni 1983
-------
Chapter Eight »»*ribit8
-------
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, aisbranded, 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 pestlcidal device that is misbranded; and
-'••-•* ^tay pesticide or peyticldal device ^that 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 pesticide!
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
ty<«ad'ilnlciae C3adm; fXitle £8 H.S.C.]. The procedure to
Initiate this judicial action requires more preparation and time than that
necessary to issue an SSURO.
FIFRA Gompliance/Bnrorcemeat 8-27 Guidance Manual 1983
-------
Chapter Eight In Be* 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 oftne
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.
FIFEA GMpllance/Bnforceaent 8-28 Guidance Mutual 1983
-------
Chapter Eight In Be» 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 legion 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.
of m 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.
Recondi tlonlng
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
nr" :jf ptfriAfi jpyi c«» is .now .in *»
-------
Chapter Eight
In Rea 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
Guidance Manual 1983
-------
Chapter Eight Exhibit 8-6
Model Complaint In Rem
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 rem 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 Rodenticlde 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
f^ 'for,-, gale,, flolrij rr-imjuirrpd or laportpd •ac .a Cpcstlr1*^0 ror
•
Fungicide , and Rodenticlde Act, as amended, 7 U.S.C. S136. Authority
to bring this action is vested In the United States Attorney by 28
U.S.C. 4547(2).
II
7 U^
FXFRA Compliance/Enforcement 8-31 Guidance Mammi 1933
-------
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)
FIFHA Gcmpllsaee/Enforeeaent 8-32 Gaidance *am***i 1983
-------
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,
1 f "^"1 p •^fty"">^.aM'A 'O^yTT' rtH^liI d***Tifc^T f*^ yamf to bp 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; which 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 ifa««i*i 1983
-------
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)
I
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)
FIFBA Co«pllance/Enforce*ent 8-34 Guidance Manual 1983
-------
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 Coapllance/Eaforceaent
8-35
Guidance
1983
-------
Chapter Eight
Exhibits
1315
V1 KB A
8-36
-------
Chapter Eight
6 Settlement Agreements
By their very nature, FIFRA civil actions do not involve settlement
agreements. Nonetheless, an injunction or :dn erem (seizure) action that
is granted 'to EPA 1>y 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.
JrirKA umpjJLance/ mtorccaent o-J/ Guidance "M"*"*' 1983
-------
Chapter Eight Settlement Agreements
FIFRA ampUance/Enf or cement 8-38 Guidance Manual 1983
-------
Chapter Nine
Judicial Enforcement: Criminal Actions
Chapter Contents Page
Statutory ^authority 9-1
Basic "fioforcement 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
compliance/anxorcement *-i r>»HHjmry n^mmi 1983
-------
Chapter Nine Contents
frlFttA (imllance/BnforceHent 9-iiQ-M .»»«•«» MamuH 19B"1
-------
Chapter Nine
Judicial Enforcement: Criminal Actions
Statutory Authority
Section 14(b) of FIFRA provides the following criminal penalties for the
"knowing /violation" of any provision of the Act:
(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 $25,000, or imprisoned for not
more than one year, or both.
(2) Private applicator.—Any private applicator or other
person not included in paragraph (1) who knowingly
violates any provision of this Act shall be guilty of a
misdemeanor «nd shall on conviction 4e fined not more
•than "$ 1 ,000, or imprisoned -lor- -not -TOT* than 30 ^lays,
or both.
Section 12 of FIFRA enumerates those acts considered unlawful under the
Act (see Chapter Seven for a complete listing.)
Jaalc 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
1 y Jt---ltM**f f -£he -Agency- .Is free to
FIFSA GoBpllance/Biforcement5-1 Guidance Manual 1983
-------
Chapter Nine Crlalnal&iforceaent
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 sclenter 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 prlaary 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., Phited 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.
FIFBA Coapliance/Eoforeeaent9-2 Guidance Manual 1983
-------
Chapter Nine Criminal Enfor
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.
Hie -requirement to prove ^culpable mental .state r -as weU 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
***" *"* "^Bmy* ^•»«r*fc hazard Chat has fmm^*^^^^ "fron^ or was
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
Iflfll
demons t rated carcinogenic potential, *t?he need for criminal sanctions should
be considered.
FIFRA umpllance/Enzorceaent 9-3 a*****^ v*nn»i 1983
-------
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 cases 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.
FIF1A Compliance/Enforcement 9-4 fttJda"?" Manaal 1983
-------
Chapter Nine Criminal Enfor
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),
fg -for ~tfr ** . frn/>"1 n g 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
D.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
falsification activity zb&t .has-— or .could reasonably be expected to
Violation of Suspension or Cancellation Orders. Sections 12(a)(2)(J),
12(a)(2)(K) and 14(b) of FIFRA, 7 U.S.C. SSl36J(a)(2)(J), 136j(a)(2)(K) and
1361 (b), establish misdemeanor penalties for knowing violations of the
terms of cancellation and suspension orders issued under Section 6 of
FIFRA. A high investigative priority will be placed on knowing violations
that result in, or threaten, significant environmental contamination or
=-" fesalth hazard.
Violation of Stop Sale, Use, or Removal Orders. Sections 12(a)(2)(I) and
14(b) of FIFRA, 7 U.S.C. SS136J (a)(2)(I) and 1361(b), establish misdemeanor
penalties for knowing violations of the terms of stop sale, use, or removal
orders under Section 13(a). A high investigative priority will be placed
on knowing violations that result in, or threaten, significant
environmental contamination or human health hazard.
Unlawful Uses of Pesticides . 'Sections < T2<*>{2;)t'G) -and 1*{V) of TOFSA, 7
D.S.C. 5S136j(a)(2)(G) and 1361 (b), establish misdemeanor penalties for the
knowing use of a pesticide In a manner inconsistent with its labeling. If
Compliance/Boxorceaent 9-5 Guidance Manual 1983
-------
Chapter Nine
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. S5136J(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. f!36a, 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
Speclal-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.
FIFRA tioapliance/Biforceiaent9-6 Cnidm"** Manual 198?
-------
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; «nd performing otter Investigative matters. A /technical person
'will-work TJith^the Special Agent drrring 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
Inspections
under authority of Section 3(a) , are contemplated. It should lie noted,
however, that Section 9(c)(2) clearly specifies that such notice is not a
prerequisite to the initiation of criminal proceedings by the Department of
Justice .
* Section 2(s) of FIFRA defines person to mean any "individual,
partnership, association', corporation, or any organized group of persons
whether incorporated or not" [7 U.S.C. Sl36(s)].
FIFKA. Compliance/Enforcement 9-7 4>"ip"*c* Mfrtn»i 1983
-------
Chapter Nine Criminal Bnfo:
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 Speclal-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.
PXFRA. Compliance/Enforcement 9-8 Guidance Manual 1983
-------
Chapter Nine Criminal Enf on
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
^obtained by ^contacting the *v*yi«ai Enforcement Division, EPA Headquarters.
• 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;
* -Guidelines oa Press Relations on Hatters Pertaining to EPA'-a
• Policy and Procedures on Parallel Proceedings at the EPA.
-------
Chapter Nine
Exhibit 9-1
Criminal Enfor
it 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
FTS 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
FTS 257-4885
Chicago Field Office
(Regions V and "
Seattle Field Office
(Regions IX and xj
Special-Agent-In-Charge
Criminal Enforcement Division
EPA - Region X
1200 6th Avenue
Seattle, WA 98101
FTS 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
FTS 234-2158
Special -Agent-In-Charge"
Criminal Enforcement Division
EPA - Region V
230 South Dearborn Street
Chicago , IL 60604
FTS 886-9874
* 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.
FXFRA Gompliance/Eofon
9-10
1983
-------
Chapter Nine Exhibit 9-2
Referral Procedure for Criminal Cases
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASMIIWTON.
9,963
MEMORANDUM
SUBJECTS Referral Procedure for Criminal Cases
PROMs Courtney M, price fVC43U->^-*'i
Acting Associate Administrator
TOt 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
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 net 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
development of the case while not providing the countervailing
benefits normally realised in the referral process, i.e.
close scrutiny of the evidence prior to filing or a final
assessment of the merits of criminal prosecution.
FIFRA Compliance/Enforcement 9-11 Guidance Manual 1983
-------
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< «ioal cases.
Attachments
FIFRA Compliance/Enforcement
9-12
Guidance Manual 1983
-------
Chapter Nine Egfaiblt 9-2
Referral Procedure for Criminal Cases
ATTACHMENT A
r
MEMORANDUM
irtf\ Jtafarral
FXDMs Special-Agent- in-Charge
Field Office
Criminal Enforcement Divis ion
Reg ional Counsel
tog ion
THJUJ:
.Associate Enforcement Counsel
Criminal JEnlorcwn«nt Division
Enforcement Counsel
TO i
Associate Administracer and General Counsel
Attached for your consideration are materials assembled
by this Agency in a criminal investigation against
2% 1* TtM nplnitm of our off i
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
jour information. We recommend immediate referral to the
(U.S. Attorney/Federal District) and to the Land and Natural
FIFRA Q*mrl1 fftir«*/^"f"«-*^»^"»- 9-13
-------
Chapter Nine Exhibit 9-2
Referral Procedure for Criminal Cases
REFERRAL PACKAGE
(Name of Case)
(Hame of District)
Z. Identity of Subject(s) of Investigation*
Individual(a)i
1. -Nat*
2. Title
3. Age
4. Boat/work address
5. Current employment
6. Criminal record, If any
7. Prior EPA enforcement action
8.- Other pertinent information
Corporation^) t
1 Hame and nature of business
2 Parent company
3 iusidiaries
4 Address of faeility(ies) associated
with offenses
5 State of incorporation
< Sise 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 ampUance/Baforceaent 9-14 Guidance Manual 1983
-------
Chapter Nine Exhibit 9-2
Beferral Procedure for Criminal Cases
-2-
XXZ. Statutory Offenses
IV? Applicable Statutes; (A summary of Federal
• environmental and related laws potentially
violated by the activity, aceoapanied by
pertinent citations to the 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
ies.}
XV. Personnel Assigned
1. Special Agent
2* Regional Attorney
3* Technical Staff
FIFBA Compliance/Enforcement 9-15 Guidance ifr««yi 1983
-------
Chapter Nine Exhibit 9-3
Page
VI. Legal Issues
VII. Environmental Impact
VIII. Recommendation
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 dlstrict(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 Ill^-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.
FIFRA Qmpliance/Enforceaent 9—17 Gsidaace Mammal 1983
-------
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
inctiie 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
Tvralts ;ef ,ta« aeglon** investigative ^activity and to demonstrate how
"the criminal conduct uncovered in that Investigation trill T1»e "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.
~***>v
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
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
-------
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 Z
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 Z and Company T.) 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 Z 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 Compliance/Enforcement 9-19 Gal dance Manual 1983
-------
Chapter Nine Exhibit 9-3
• Any facts that bear on the reliability of the available
evidence. This night 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:
* ....L^gai .Defg"ges.» - Th*" .might JLnclude»-.for example^ .arguments
that - ,a, discharge 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
'^5ffcV 31 fT ^ *"^^*T?gu3 ytyy' it*"mfn*TH t B "tfr^ .cost of pffmpl'Eyc^ t
labor difficulties at the facility, etc.
In completing this section, speculation should be avoided. Potential
defenses should not be Included unless there Is some basis for their
assertion under the facts of the case.
Section VII—Environmental Impact. This section should provide an
«-ho n* jn-if-i/'nTVPo rtf th" urTlrfflimfmtal him or him an
Precise statements in this area are not essential elements of most
criminal offenses and will often be difficult to support scientifi-
cally. When the investigation focuses on historical rather than .
ongoing conduct, or involves falsified technical documents, the"^-1""
task becomes even more difficult. Normally, however, an educated ,%
estimate— based on the type of pollutant Involved, the location,
assessing the gravity of the misconduct.
^provide "«ie*«lgaif$enxt basis for
y IITUA QffBpl 'j m-nffjfVnfevrfttm&nt' 9—20 Q*4^P*\ff tlmwtnmt 1983
-------
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.
FTFKA Compliance/Enforcement 9-21 Guidance Ifannal 19A3.
-------
Chapter Nine B»fri^Bllcg iton^i 1933
-------
Chapter Ten
Post-Settlement .Enforcement
Chapter Contents
Page
Monitoring Settlement Agreements
Enforcement of Settlement Agreements
10-1
10-1
FIFKA umpllance/EoxorcBent
10-1
Guidance
1983
-------
Chapter Ten Contents
FIFBA GoMpllance/EnforcMmt 10-Ii Gn
-------
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 FIFRA 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.
FIFRA Compliance/Enlorcment 10-1 Guidance Manual 1983
-------
Chapter Ten
Post-SettX
.t Enf 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.)
oompiinnre/anrorceaent
IV-2
19B3
-------
Chapter Eleven
Special Considerations
Chapter Contents Page
FIFRA Section 7 Confidential Information 11-1
Disclosure of Confidential Information 11-3
frifltA Compliance/Enforcement 11—i Guidance n»»i««ai 1983
-------
Chapter Eleven
Contents
FIFBA Cb*pll«nce/Enlorce»ent
11-11
Gntiaitca Manual 1983
-------
Chapter Eleven
Special Considerations
FIFRA Section 7 Confidential Information*
Under TIF8A Section 7 J»nd 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^) of JJFiA states: ."Any Information submitted to the
TTT Tf* 'BTIJTff^Pt'lf*!! (t*\ 'Otfr^T 'f^**" ^Iff UTTT*0 Of
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
•*" ISonfliieptlal ItifoTmatiw wftmitted pxirsnant =t»"Section 3 'bf ¥1P1A 1*
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/Enforcement 11-1 Goldmen Manual 1983
-------
Chapter Eleven Confidential
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.
PIPRA GoBf>llaace/Snforceaent 11-2 Qnrfd'BB'p* Manual 1983
-------
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 Nonconfldentlal 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.
• Nonconfldentlal Information. Information submitted to the Agency
by a producer operating an establishment and deemed nonconfIdential
•Under "Section 7 Jnp3ul j discloaures too fhyaicians,
'
Injury or to prevent Imminent harm to health, property, or the environment
[40 C.F.R. S2.307(h)(2)]; and disclosures to contractors [40 C.F.R.
f 2.307(h) (3)].
The Associate General Counsel has ruled that EPA may not disclose to States
(or their employees or representatives) confidential information obtained
•by SPA Tmrrrnimr to flection 7(c) of
11-3 (*i44»nf*> Manual 1983
-------
Chapter Eleven
Confidential Information
1983
Co»pI1«nce/Baforceaeat
-------
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 Aril
Permanent Abeyance (PA) Procedures A-12
Records Retirement and Retrieval A-12
romp! 1 mnrr/FnTorcrmcnt A—1 Guidance »""««*' 1983
-------
Appendix Conti
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
EorceaenF" A-ii
-------
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 unprpgramaed inspections, however,
are ant, subject ;to neutral Inspection •chuaf Jgqolrements. (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
iftroducer ^atafe]igJwnts *re Inspected at least /once every two years.
Ouwever, 'where TlolatlmM of the Act iiave 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:
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
.been .Inspected .and .nhere .yiaLatloas &f tbe Act Jiatre Aeen.Joand*
oomplirnncf/atxoTrfmf nt A-l Guidance »i««^ii 1983
-------
Appendix Beutral Adminl strative 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 59(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
• Speciflc*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.
A-2 Girl dance Manual 1983
-------
Appendix Heutral *d^*"-*ptrative 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 f the establishment) were
found.
Restricted Use Pesticides
It is EPA1 s intention to conduct an Inspection at least once every two
years at each pesticide dealer establishment where restricted use
pesticides are sold. However, where violations of the Act have been found
during a programmed Inspection^ .a .follow-up .inspection Is to .take place
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 dealer establishments that sell
restricted use pesticides and that have been Inspected during the
Category II*— a list of those dealer establishments that have been
inspected during the past two years and where violations of State
or Federal pesticide laws have been found.
The initial Category II list should also indicate whether any follow-up
inspections were conducted, the date(s) of any such follow-up inspec-
tion^), and whether or not any further violations were found.
FJJTKA. UDvpxiance/amor cement A—3 Guidance M«MM»I 1983
-------
Appendix Hentral A*frd «•*««•*•*«• *™» 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., juvenile 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.
uoap-Liaace/ aB±orcfc»ent A-4 Guloance MmnM*' 1983
-------
Appendix
2 Notices of Judgment
Authority
Under .Section 16.C4) of .F/IE8A, xthe-.Adainlstrator of EPA IB required to give
notice ^ -publication of all judgments entered In 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 pesticidal products and devices. A notice of Judgment contains
the following information:
• Responsible party;
• Specific violations;
• Dates and nature of the legal action; and
gf* "T* r
Agency Policy
The Agency publishes a notice of judgment for each seizure, criminal
£olla«ing Ins
• Seizures . When no product is available for seizure;
• Criminal Cases. When cases are declined for prosecution by the
U.S. Attorney; and
,* Civil Q3«T)1alTrr«. ««n civil maplalnr.* are vttndram toy the
ore t5ie respondent files an answer.
In civil penalty cases Involving a hearing before an Administrative Lav
Judge, the entire initial decision will be published in the notice of
judgment.
FIFBA ampliance/Biforceaent A-5 frr'ifim'^ Manual 1983
-------
Appendix notices of Jud
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 act loo, 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.
FIPMA. Umpliance/EnforceiMentAH> " Goldi
-------
Appendix _____ Botlcea of Judgment
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.
uoapxxance/Enxorceaent A—/ Guidance MJ«^IJ»I 1983
-------
Appendix Exhibit A—1
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 BRAND 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 Rodent icide Act, 7 U.S.C.
Sl36k(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/Enforceaent A-8 Guidance »*•*•«"•'* 1983
-------
Appendix Exhibit A-2
Hotlce 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 , Z.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 shipment (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 ,
^Vancouver, Uashiagton.
b. A product (s) held for distribution or sale
on _ _ _ _ ,
(Date of Inspection)
at _
(Name of Producer Establishment;
*•*>-.'
_ •
(City and State)
The peBtlcide(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— -
- ~no£ f
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.
FIFBA Compliance/Enforcement A—9 Guidance M**m*i 1983
-------
Appendix
Exhibit A-3
Botlce of Judgment of dvll Penalty Proceeding
In Be: Steelcote Manufacturing Company
EPA Region VII
(Name of Bespondent)
September 3, 1974
(I.F.&R. No. VII-46C
(Date of Final Order)
, Z.D. No(s). 91563
This was a civil action charging the respondent with violating the
Federal Insecticide, Fungicide, and Bodenticlde Act, 7 U.S.C.
Hl36j(a)(l)(E); 136(q)(l)(A); 136(q)(l)(F); 136(q)(l)(G); 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 Company
(Name of Producer Establishment)
St. Louis, Missouri »
(City and State)
The pestlclde(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 Ooapli imce/Enfo
A-10
Manual 1983
-------
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.
-m 4feey«nce. -iftfter It few *e«n itetermlned 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
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.
FIFBA Compliance/Kiforce»ent A-11 Gnldanc* Manual 1983
-------
Appendix Sa«ple Record Status and Pciw"1**"! 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.
FIFBA Compliance/Enforcement Arl2 " f*,i*™™ M«m*l KMH
-------
Appendix
4 Collection of Civil Penalty
Assessments
Authority
Upon nonpayment of a civil penalty within the prescribed time periods,
Section ;14(a>(,53 ,of
-------
Appendix Collection of dvll 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 tine in which he
or she has to pay it. Such notice should also inform the respondent of the
consequences of failing 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 mall 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 PTSGMS 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 Begional Office
from referring claims to the United States Attorneys Office for collection.
UMpxiance/mzorcement A— m Guidance rfr*""" 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 Begion in which the final
order was issued.
1tn«»Ti«-a
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 FIFRA 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:
• 3e an a regular 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
• • Bo
In allowing a respondent to pay by installment, the regional attorney
should attempt to obtain an executed conf ess-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 conf ess-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 Compliance/BBZorcement A-15 Qn-idmce Manual 1983
-------
Appendix Collection of Civil Penalty Assessments
or when the litigative 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.
FIF1A OoBpllance/Enforceaent A-16 Gnid«r*M Manual 1983
-------
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.
Tteferral "Parties and "Minimum Amounts
Department of Just1ce« 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
•«ttuca«yei&utalA pt^pare
-------
Appendix Exhibit A-4
CHAPTER II—FEDERAL CLAIMS COLLECTION
STANDARDS (GENERAL ACCOUNTING
OFFICE—DEPARTMENT OF JUSTICE)
Part Page
101 Scope of standards -------- . — ~—...~. .............. ~..~.. 90
102 Standards for the administrative collection of
.................................................. 91
103 Standards for the compromise of claims~.~.~~......~. . 95
104 Standards for suspending or terminating collec-
105 Referrals to GAO or for litigation ..*...__.._._
FXFRA GoapllaD.ee/Enforceaent A-18 ^Unn**** Manual 1983
-------
Appendix
Exhibit A-4
§101.1
PAW 101—SCOW OP STANDARDS
Bee.
10L1 Prescription of standards
10U Omissions nota defense.
1O1J moid, .antitrust and taariairas ex-
101.4 Compromise, waiver, or disposition
under other statutes not precluded.
101.6 Subdivision of claims not authorised.
101.7 Required administrative proceedings.
101J Referral for litigation.
AmBoarrr Sec. 3. 80 Stat. 309; 31 U.S.C.
982.
Soncc 31 FR 13381. Oct. 18.1966. unless
Otherwise noted.
«UOU Jiasois^iaavstfslsssisiili.
The regulations in this chapter.
Issued Jointly by the Comptroller Gen-
eral of the United States and the At-
torney General of the United States
under section 3 of the Federal Claims
Collection Act of 1966. 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-
tainmjin Xttte 4 of the General Ac-
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.
144 FR 23701. Apr. 17.19791
• 10L» jQstttntont ant adefa
ter shall apply to the administrative
hunting of dvO ginima 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, antitrust
lax .daisas
The standards set forth in this chap-
ter do not apply to the handling of
any claim as to which there is an indi-
fMo
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 OB 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 this chapter because
there is an indication of fraud, the
presentation of a false claim, or mis-
representation on the .part of .the
-debtor •or .soy other 'party having .an
Interest to the claim, may be returned
to the agency forwarding them for
further handling in accordance with
the regulations in this chapter if it la
determined that action based upon the
alleged fraud, false gi*<"v or misrepre-
sentation is not warranted. Tax claims,
as to which differing exemptions, ad-
ministrative consideration, enforce-
ment considerations, and statutes
apply, are also excluded from the cov-
erage of this chapter.
9101.4 Compromise, waiver, or disposi-
tion under oilier statutes not pw-
Nothing contained in this chapter is
Intended to preclude agency disposi-
tion of any claim under statutes other
than the Federal Claims Collection
Act of 1966. 80 Stat 308. providing for
the compromise, termination of collec-
tion action, or waiver in whole or in
part of such a claim. See. e.g.. "The
Federal Medical Care Recovery Act"
34 Slat 483. 42 O.S.C. 5651, «t awj,
ihittnns. 38 CFR
43.1. et seq. The standards set forth in
this chapter should be followed In the
disposition of civil claims by the Fed-
eral Government by compromise or
termination of collection action
-------
Appendix
Exhibit A-A
Ooiim Collection Standard*
• 101.5 Conversion daima>
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 claims may be dis-
posed of for less than the full amount
claimed. Nothing* contained in *•**<«
chapter is intended, however, to deter
an agency from ^•"««f **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 Subdivision of claims act author-
A debtor's liability arising from a
pm-»jui«i be specified and. nor-
mally, should be not more than SO
days from the date of the Initial notifi-
cation. Three progressively -jtrbnger
written demands at not more than to-
day intervals wU normally be made
unless a response to the first or second
demand indicates that further ^t^nnjH
would be futile and the debtor's re-
sponse does not require rebuttal. Fur-
ther exceptions may be made where it
91
FIFBA Goapliance/Enforcement
A-20
ance
1983
-------
Appendix
Exhibit
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 is to be received. See 5
U.S.C 5514.
(b) When the head of an agency, or
his designee. pursuant to 5 VAC.
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 service or .amount «f
"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-of fset oral hearing
when:
(1) The debtor requests waiver of
the indebtedness and the waiver deter-
mwtwmtbetadlvW-
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, far fmMnpte. when the validity
of the debt turns on an Issue of credi-
bility or veracity: Provided that, where
paragraph TTg
144 TO 37702. Apr. IT. 197M
81ttJ CollecUon by offcet
(a) Collections by offset will be un-
dertaken administratively in accord-
ance with these standards and imple-
menting regulations established by the
«bead ofveacfa .agency «n claims which
tn
offset hearing, the agency may with-
hold from amounts m?cfvfT*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-
, smined *not Bowing 'to the Government
• shall 'be^proraptly refunded.
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 1 10&2 of this part and
include therein:
(13 notice ol the agency's mtenthm
tOiCoUeet 4y roffs«t: <2) an opportunity
to request reconsideration of the debt.
or If provided for by statute, waiver of
the debt, and (3) an explanation of the
debtor's rights pursuant to this sec-
tion.
(d) Collection by offset against a
Judgment obtained by the debtor
against the United States shall be ac-
complished in accordance with the Act
-------
Appendix
Exhibit A-4
Chapter II—Federal dalm CoilocHon Standards
5102J
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 initial notification, unless
satisfactory payment arrangements
are made by the date due. Agency pro-
cedures for reporting delinquent debts
to credit bureaus must give due regard
to compliance with the Privacy Act of
1974. as amended, 5 VAC. 552a. which
Includes the following requirements:
(a) Promulgate a "routine use" for
the disclosure; (b) keep an accounting
for disclosures and make them availa-
ble to the debtor, (c) provide the credit
bureaus with corrections and nota-
tions of disagreement by the debtor.
and (4) 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. 17.1979J "
11015 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. 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 552a.
and. when applicable, to Federal and
State laws and regulations pertaining
to debt collection practices such as the
Pair Debt Collection Practices Act. 15
UJB.C. 1692.
(46 FR 22393. Apr. 20.10811
9102.6 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.
Iti FR 13381. Oct. 1A. 1M6. Rfdeattnated at
44 FR 22702. Apr. IT. 197f and 46 FR 22353.
Apr. 20.19011
• ltX.7 Contact wtth debtav'a amployinf
agency.
Whan a debtor to employed by the
Federal Government or to a member of
the military establishment or the
Coast Guard, and collection by offset
cannot be afpoi"pn»h**i tn 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.
ISO (30 PR 6469).
[31 FR 13381. Oct. 10.1066. Redesignated at
44 FR 22702. Apr. 17.1970 and 48 FR 22353.
Apr. 20.19811
I10L8 Sutperafon or revocation of II-
eeaac or eligibility.
Agencies seeking the collection of
statutory penalties, forfeitures, or
debts provided for as an enforcement
aid or for compelling ooTnpHnp*^ 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 wfll be so advised. Any agency
making, guaranteeing, insuring, ac-
quiring, or participating in loans will
give serious consideration to suspend-
ing or dfffn'flllfytpg yny tendg*, con-
tractor, broker, borrower or other
debtor from doing further frw*"*y
with It or engaging In i*"1*!'*™ spon-
sored by it If such a debtor falls to pay
its debts to the Government within a
reasonable time and the debtor wfll be
so advised. The failure of any surety
to honor its obligations m accordance
with 6 U.8.C. 11 to 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
o /Vrtf rvro
<•>,.-» J.
.— v—..-1 moo
-------
Appendix
Exhibit A-A
5 102.9
131 PR 13381. Oct. 15. I960. Redtsignated at
44 PR 33702. Apr. IT. 1979 and 46 PR 23393.
Apr. 30.19811
01024 Liquidation of collateral.
holding .-. security or collat-
eral which may be liquidated and the
proceeds applied on debts due it
through the exercise of a power of
sal* in the security instrument . or a
non-judicial foreclosure should do so
* by such procedures if the debtor falls
to pay his debt within a reasonable
time after demand, unless the cost of
dlnpimlng of the collateral will be dis-
proportionate to its value or special
Judicial .foreclo-
erwMirces, In-
cluding- 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.
131 PR 13381. Oct. 15. 1966. Redesignated at
44 PR 22702. Apr. 17. 1979 ami 46 PR 22353.
Apr. 30. 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 fl-
jundaUjr unable ^Qjpay.^he indebted-
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-
alble the installment payments should
be sufficient in size and frequency to
liquidate the Government's claim in
more than 3 years.
payment* of less than $10 per month
holding an unsecured claim for admin-
istrative ffrtliftlon 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
TM»
- - .
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.
(31 PR 1338L Oct. 15. 1986. Redesignated u
44 PR 2X703. Apr. 17. 1979 and 46 PR 22353
Apr. 2ft, 19811 .4t
• 102J1 Exploration of compromise.
Agencies wfll attempt to effect eom-
promi*es (preferably during the course
of personal Interviews), of claims of
$20.000 or less exclusive of interest, in
accordance with the standards set
forth to Part 103 of this chapter in all
-in .which, .It can be ascertained
^debtor's financial ability will
not permit payment of the claim in
full, or in which the litigative risks or
the costs of litigation dictate such
action;
C31 PR 13381. Oct. 15. 1966. Redesignated at
44 PR 29702. Apr. 17. 1979 and 46 PR 22353.
Apr. 20. 1981]
• 10242 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
l 'Requirements
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* .•fotoH .-the claim ^arises
est.-Bee Rodgers v. United States, 332
U.S.371.
144 PR 22702. Apr. 17.1979. Redesignated at
46 PR 22353. Apr. 20.1981]
• 102.13 Analyafe 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 Ompliance/Enforceaent
A-23
Guidance Manual 1983
-------
Appendix
Exhibit A-4
Chapter Il—Fed«roi Claims Collodion Standards
fectlvenesa 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
pjirHmiim debt amounts below which
collection efforts need not b* taken.
Cost and recovery data should also be
useful in Justifying adequate resources
for an effective collection program.
(44 PR 2270* Apr. IT. 19T». Radesl«nated at
46 FR 32353. Apr. 20.1981}
8102.14 Documentation of administrative
eoUectfaM 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. 19.1966. Radesisnated at
44 FR 22702. Apr. 17.1979 and 46 FR 22383.
Apr. 20.19811
§102.15 Automation.
Agencies should automate their debt
collection operations to the extent it is
cost effective and feasible..
(44 FR 22702. Apr. 17.1979. Rcdesignated at
46 FR 22353. Apr. 20.19811
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 coTr"rT>*friH^ credit bu-
reaus.
(44 FR 22702. Apr. 17.1979. Redttignated at
46 FR 22853, Apr. 20.19811
1102.17 Additional adminbitrative collec-
tion 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. Redesignated at
44 FR 22702. Apr. 17.1979 and 46 FR 22353,
Apr. 20.19811
PART 103—STANDARDS FOR THE
COMPROMISE OF CLAIMS
103.1 Scope and application.
10X2 Inability to pay.
103J Utifatlvc probabilities.
103.4 Cost of coueeUnt claim.
103 J Enforcement policy.
1M.6 Joint and several liability
ltl.7 8etutm*nt for a
of
103.8 Further review of compromise offers.
10L9 Restrictions
3. 80 Stat. 309: 31 T3AC.
952.
31 FR 13382. Oct. 15. 1966. unless
otherwise noted.
• 1*3.1 Scope aadappJteatkMi.
The standards set forth in this part
apply to the compromise of rt*img_
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 deslgnee 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.
IIOU 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 tune by en-
forced collection proceedings. In deter-
05
FIFRA Gonpliance/Enforceaent
A- 24
Guidance Manual 1983
-------
Appendix
Exhibit A-4
-,\
31OL3
mining the debtor's inability to pay
the following factors, among others,
may be considered:
Age and health of the .debtor; pres-
ent and irrtyrttal 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
proceedings. 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
xoQeetion.'Uncertainty ~*B to the price
which eoU»4eral orather property wm
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 in**Al'lt*<*T*t 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 • weeing a compromise
proposal such Information may be ob-
tentridaal debtor by
Berated roder
THto 4-Aceoynt
.* - •*"
amount claimed either because of the
legal issues involved or a bona fide dig.
-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 it is unsuccessful in
litigation. tearing 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 :effteet caUectlnn. Cost of eattectmg
^STrtWaBttal factor tntiie set-
tlement of small claims. The cost of
collecting claims normally wfll not
carry great weight in the settlement of
large claims.
• 10X5 Enforcement policy.
Statutory penalties, forfeitures, or
debts established as an aid to enforce-
ment and to compel compliance may
to
penalty of perjury showing the debt-
or*s assets *w* liabilities, income TJM*
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 reel doubt
concerning, the Government's ability
to prove Its case in court for the full
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
lati
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
FIFRA Compliance /Enforcement-
A-"*1*
-------
Appendix
Exhibit A-4
Chapter II—Federal Claim. Coltectfan Standard*
f 100
-should not attempt to allocate the
burden of paying such claims as be-
tween the debtors but should proceed
to liquidate the Indebtedness as Quick-
ly as possible. Care should be taken
that compromise with one such debtor
does 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 wffl be
required from other debtors Jointly
and severally liable on the claim.
9103.7 Scttteowfit for a casflbuMtioa of
A claim may be compromised for one
or for more than one of the reasons
authorized in this part.
8103J Farther review of
off*
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.
• 10&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 befgiven to requiring a waiver
of the tax-loss-carry-forward and tax-
loss-carry-back, rights of the debtor.
PART 104—STANDARDS FOR SUS>
FINDING OR TERMINATING COL-
LECTION ACTION
Sec.
104.1 Scope and application.
104.2 Suspension of collection activity.
104 J Termination of collection activity.
104.4 Transfer of claims.
AuTBOmrrr: Sec. 3. 80 Stat. 309: 31 TL8.C.
992.
Souacs: 31 FR 13383. Oct. IS. 1986, unless
otherwise noted.
• 1*4.1
application.
The standards set forth in this part
apply to the suspension or termination
of collection action pursuant to sec-
tion Mb) of the Federal Claims Collec-
tion Act of 1988. 80 Stat. 309, on
claims which do not exceed $20.000 ex-
clusive of interest. The head of an
agency or ***r designee »***y suspend or
w67DuQe%w£ OO^i0CUQJl 4%COOO UQflCr
part with respect to claims for money
rty arising out of activities of
his agency prior to the referral of such
f*Tt<»Ti« 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.
81*4.2 ^uapemien of coOtctioa aeuVtty.
Collection action may be suspended
temporarily on a claim when the
debtor cannot be located after diligent
effort and there to 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 stae and
the amount which may be realized
thereon. The following sources may be
of assistance in locating missing debt-
ors: Telephone directories: city direc-
tories; postmasters; drivers' license rec-
ords; automobile title and license rec-
ords; state and local govc
agencies; district directors of Internal
Revenue; other Federal agencies; em-
ployers, relatives, friends; credit
agency skip locate reports and 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 ^""^tBttfl***! such as
Pub. I* 89-805. 80 Stat. 904. to permit
the timely fulng of suit if such action
to warranted. If the missing debtor has
signed a 5y*pfyOT-J"'*gm»T»t note and is
in default, referral of the note for the
entry of judgment should not be de-
layed because of bis missing status.
97
FIFRA Co»pliance/Enforces«nt
A-26
Manual 1983
-------
Appendix
Exhibit A-4
510*3
Collection action may be suspended
temporarily on a claim when the
debtor owns no ffvtM>te»«tMy*gd. the applicable statute
of llr"*tytlTfnn fry* run, and the pros-
pects of collecting by offset notwith-
standing the bar of the statute of limi-
tations Is too remote to Justify reten-
tion Of frt*P «
109.1 Prompt referral.
109.2 Current addreai of debtor.
109.3 Credit data.
105.4 Report of prior collection acUotu
10&6 Preservation of evidence.
109.6 Minimum amount of referrals to the
Department of Justice.
TTB.C.
claim when it is likely that the cost of
further collection action wfll exceed
the amount recoverable thereby.
952.
Bourne* 31 PR 13384. Oct. IS. 1966. unless
otherwise noted.
98
A-27
Guidance
1983
-------
Appendix
Exhibit A-4
Chapter II—Federal Claim* ColteHaa Standards
(105.6
9 1*5.1 Prompt rtfemL
on which collection Action
has been taken in accordance with
Put 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 ltd. 236, as
amended. 31 UJS.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 addrett 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
• ItU CMStdeta.
Claims referred to the General
Accounting Office, and to the Depart-
ment of Justice for litigation, wfll be
accompanied 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
under
ecuted
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
1C (1) A surety bond la available in an
1*jS.lfH
in fun. (2) the forced sale value of the
security available for application to
the Government's claim is sufficient
to satisfy its claim in fun. (3) the re-
ferring agency wishes to liquidate loan
collateral through Judicial foreclosure
but does not desire a deficiency judg-
ment. (4) the debtor la in bankruptcy
or receivership, or (S) the debtor's lia-
bility to the Government is fully cov-
ered by insurance, to which case the
agency wfll furnish such information
M it can develop concerning the iden-
tity and address of the insurer and the
type and ***MW"*t of Insurance cover-
age.
§ Ift5.4 Report 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 Is 1rT*Mff***l*n^ Justi-
fication for th» omission of vnt or
more of ^f** ^<*TT>tri<*trattvf collection
actions enumerated in Part 102 of this
chapter.
• it&fi
Care wfll be taken to preserve an
files, rffcordi* ar***
f erred or to be referred to the General
Accounting Office, or to the Depart-
ment of Justice for litigation.
0 105.* Minimum amount of referrals to
the Department of Justice.
Agencies will not refer claims of less
than $600. exclusive of interest for liti-
99
FIFRA Govpllance/Enforcenent
A-28
Guidance Manual 1983
-------
Appendix ___ Exhibit A-4
5105.7 IK*
cation unless: (a) Referral is impor- f 10S.7 Referral* to GAO.
C^^QL to A ftiyni i iftflnt cBiOFCdncut' * ^* * i^ ^ » i ^ ^a_. ^«
^^^^ ^^ - *"*•"•-- "w TJB^»•»»— -•••- •CtfftflT&Js Oi ^iammt uk rfi^ Q^ti^MMh• •
policy or (b) the debtor harnot only JlSr: SfSSr^m h.i» iSS
Office will be in
the clear ability to pay the claim but
the •Ooyermnent -can effectively ^ en-
feree payment havinff due retard to "" Office
under state or
Judicial remedies available to the Gov
ernment
£43 PR 38891. Aug. 1. 19773
100
FXFHA Oo»pltance/Enforce»ent 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 Rodenticide 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 OovpUance/Enf oreement A-30 t^iUm?* 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 -the 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) .
You 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
the United States. In, this proceeding* yon^vlll -?be barred from
of fact or iof JL*w -C&at *fcDald fcave 4>een raised
In the administrative proceeding.
Title
IPA Jtegion
Date
At
FXFRA.
A-31
Guian
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.P.R. $105.1 et MjqO.
In cooperation with the General Accounting Office, torn attached
Claims Collection litigation Report (CCLR) has been developed by
the Debt Collection Section of the Executive Office for United
States Attorneys, Department of Justice, aa 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.P.R.
j102rhet 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 Compliance/Enforcement
A-32
Guidance .ttemui 1 1 Q«T
-------
Appendix Exhibit A.-7
the agency's final determination of the amount of the claim.
If, as stated in the Item Explanation, preparation of the CCLR
if sade 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-
Mill improve the efficiency and speed with which
l,'-*s,« result,, Justice should be able to
better serve its client agencies.
Because of the uniform order and sequence of this standard
report, it will be possible, if an agency so chooses, to provide
merely the answers to Items 1 through 51 of the report seriatim.
This means that instead of inserting answers to Items 1 through
51 on the actual CCLR form, an agency stay follow the standard
format of the report, as illustrated in the attached Exhibits 1
through 6, down to Item 1 of the report, and then at that point
merely provide a running list of only the Item numbers and
corresponding answers for Items 1 through 51. The actual CCLR
form and the accompanying Item Explanation would then be used
by the agency as its pattern, guide, or key for providing the
answers in the running list. When a running list is provided
in lieu of inserting the answers onto the actual report .form,
-'Jiuasj »*j. „ ^yemmr •flesirmy'smpald^ vtmicmnjby - the agency to .assure
'iTiis^j';tn>-..JtsmirgmmmAs3C>'^smd'jeaso rM«m~<»i *<">*
-------
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 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 made within 10 days
(please note that this letter need only be prepared
and included in the CCUt package for those United
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
United States Attorney to officially notify the
agency that the claim which was referred has been
received and will give the referring agency the
United 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 United States Attorney to send
deficient claims, or claims which the United 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 Jifrtice are for litigation following aggressive administrative
collection action~by the referring agency, and that on the basis
of the information contained in the CCLR, including tne agency's
oTtermination ot tne debtor• s~"abTTTty 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 a substantial turn. Any
omissions should be explained in the appropriate item on the
face of the report. -
-3-
FIFIA Coapllance/Enforceaent A-34
-------
Appendix Exhibit A-7
we realize that as 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 comments or suggestions frost agencies using
the report. Comments should be brought to the attention of
Mr. Edward B. Puns ton, > Assistant-. Director, Debt Collection
Section,: Executive Office, for O. S. Attorneys, Suite 803,
5205 Leesburg Pike, Falls 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 Ooapllance/Boforceaent A-35 4>y»dapcg Mami^l 1933
-------
Appendix
Exhibit A-7
Xfe
CLAIMS COLLECTION LITIOATICN
(OB MBBTWMM o* r«f«rrlng
Toi X»lt»d Stataa Atlonwy ™
XMdlclal Olrfrlctl of (Statal
XCIty, *rata. Zip Cedal
taB Ctota CMIOBftai Iklt
r'» full «•• (LMT, rirrr. Hiddi«)l
XOMter't Ml I Ing «Mr«Ml
tat
XTItUI
MMtlll«g
xrrs
MDabtor't fllo or
I* tl
U 1t
XIAaoMrfl !• tl
If
U tta total poMlty ekaroM
Xtatcl
TkU «)•!• I* rvtorroj 1» yo« for suit wri Mdi otMr «et
CDlloetlod. TM prior •etloN tMtM oy IftU •jury Md
pllo* fvlly •Ittt rogoral Cl«l« Colloetloii Standard* (4 Cflt
r 4 O« Part* l«-4«9 la artaaaa* aM tha ii
la tk>
la ttia
la tha
ito iMforwttoii ro»l«M you
MM>tat
fol lorn.
I. 0«t» e* •Irnii
2. Seelvl
3. AIM kiwi MI
ILltt «HMM of
. If mo»m.|
COo» »eta«l »l«e» of r««ld«>e». rat
10. aaala of elai*
-------
Appendix
Exhibit A-7
>T<
>*<
II. Statuta of limitation* (SOU) run on: 12. Baala for SOL datat
(12. coKt'd.)
13. Hr*t
tl
14. rtrvt ««Md •*•• by I
IMho. !.«.. woirt. offlelil. offloTI
19. Mutfta* of flr«t •aaaad:
IC.Q.. tOftar. aalloraall
I0rt»71
17. U*r *a*aad aada byt
tttOa ••"*• official, off leal)
It. M>ttad of Iwt «BHndi
IE.a.. lottv. DtaM. Mrwiwl eontaeTTI
21.
>, If aay. to tfabtor't alspotai
to daetar'i v net? If »a«. »«iat action and unat
1 Gloa grtiar rala»ant
30.
31. »M»iT Mil** to principals
. .1
33. Balance 4m on principal:
S
•
s
f3§_ ^nt*d.l ^.li^ii. mfm «M K» •MQI l^rf I
33. bvlala apalleaftaa of aayHotmi
b^laln haw Mvaants raealvad troa tt»
36. 0*Btw>« iMt poriMirr:
tlAaomrt »ad dalvTI
37. latw
fTh«
ccrual catai
froa •nlcn Intaraar It
-2-
) .
FXPEA Cbapllance/Eoforceaent
A-37
Guidanc
1983
-------
Appendix
Exhibit A-7
••8 <
41. SM I" *•'«> t«* U»ltw
« InfWMti
and al»« l««t mo^ lootleo of
In •nlgi rt» uilt«a St»T» tf»
y«ti» of aruumti U«T»a (oitentl.l
47. it
or Mid In ivmm\.», tta f«k>
E»el»ln t»nl« «ar f»lr •r»y» or
• •!••» »•!•• a* tnis elulrn woult Mi
v«lunTlo« alvxi. If any. I
« «t>lllty « pay. M
by T
6rpl«ln In
toy ajawttaa) 44.
•114 Ml
jJ1ncia»i dilc* can M i
off lor
I at leu
-J-
FIFBA Gcmpliance/Eoforceaent
A-38
uiane
1983
-------
Appendix
Exhibit A-7
If I «M B* o? «y f«rt»nr •nlstmes in
•(*•» do «0r Mwtt*f* 1» all ••
XHMMl
»mti*i
rw» If inf
TM i«Mal*, "• erccMti, m* tarn, or tfo «w* •ifkl« •ITIMT of ita l»nw «ll I nor
••ear an m* flMl ty»M w prtirt»a report. Bur tov* kMn laciuAM ««r» to «pl*l» or
civl*r **• «pMfiam/l«««. H» mryln m* MB vttings «^ JMIcrfM an HM flr«T
HIM. Ow» wt, tt»r MM nor t» atmgml 1v
-------
Appendix Exhibit A-7
BKTAILBi
If or* tuct it rutuirut, «• t«ri limn «f »wv Urn imm *ln •§ «•!•
b^ilari MB* 8.
FXFRA GoMplianee/fioforceaent A-40 Guidance Manual 1983.
-------
I
19
I
£
5
ft
T
-------
Appendix Exhibit A-7
lieu of inserting the answers onto the actual report form, however, great car*
should ba taken by tha agency to assure that the Itam numbers and answers pro-
vided in the running list umieatJutJ to the Item nunbers on the report. This
method of providing information should both simplify and expedite tha agency's
preparation of the OCLR. In addition, it should allow for batter utilization
of available ward and data processing equipment to prepare the report.
As both the OCLR and the following explanations state, all documentation
which supports the claia 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 package!
1) A Otrtificate of Indebtedness which will provide the united States
Attorney with a coapleta statement of how the claim arose (including
the statutory, regulatory, or other authority fro* which the claim
arose, a sunary statement or resume of the factual basis for the
claia, an itamization of tha dates and anounta of any payments made
by the debtor to the agency or any credits made by the agency to the
debtor, and an itamization of the amount due and owing) and which
may ba offered by the united States Attorney into evidence to prove
the claims
2) A Dtpmment of Justice Demand Utter (Exhibit 8) which will be
used by tha United States Attorney to notify the debtor that the
Department of Justice haa received the claim for litigation and
suit will ba brought unless full payment is made within 10 daya
(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 Depatuaant of Justice Acknowledgment {"Comeback Letter') (Exhibit
9) which win ba 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 Dominant 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.
Qw letters should be prepared in the same format reflected in the exhibits.
TOP FOKI'XCN
,.*,. Date: Show the date that the OCLR is signed.
Inside Address Slnply show "united States Attorney," the
or "To" Blocks Federal judicial district, and the city,
state and zip code. The judicial district
nay be written, •Southern District of Iowa,1
or "District of Kansas," as appropriate.
The state can be the accepted two
-2-
FIFRA Goajpliance/Eaforcesjent A-42 Guidance Manual 1983
-------
Appendix
Exhibit A-7
letter abbreviation. A couplet* sail ing
fiifi'^x for the United States Attorney
should be provided on the nailing envelope.
(Brtiibit 11 providea current nailing
tor United States Attorneys.)
•From- Block:
Debtor's Pull Name:
Debtor's Mailing
Address:
Debtor's File or
Reference Number.
Ibtal Principal Dues
•NaBorandutT or 'farm" for-
title, complete Bailing
(Mien using the
.mat] Show .the name,
address and FTS telephone nmber of the
agency official who will sign the report
Tbtal Interest Due:
total Administrative
fiue;
Show the last, first and full middle name
or middle initial of the debtor, tttere
appropriate, indicate whether debtor is
a 'St.," -Jr.," "II," etc.
Show the complete mailing address for the
debtor which has been verified by the agency
wdtnin-the past six months.
Show the agency's debtor file or reference
lumber.
Show the amount of principal due en the
claim. there tees and costs advanced are
to be recovered from the debtor, include
them in the principal. The Certification of
Indebtedness which you attach should include
an explanation and itemizaticn when the
total principal due is a cumulative total
and combines separate items (e.g., recover-
able sees and o >atfl advanced, promissory
notes of different dates or amounts).
Show the total aipunt of ,intc
Indebtedness which you attach should include
an itemization and explanation of interest
charges and when, for example, the total
interest due includes separate items such as
interest due on more than one promissory note
or a aeries of discrete claims, each interest
charge should be itemized and explained.
Snow the total amount, through the date of
the Certification* Indebtedness, «f any
by the agency to covet the costs of
processing and handling the claim pursuant to
tbe Debt Collection Act of 1962, P.L. 97-365,
$11(e)(2). Ihe Certification of Indebtedness
which you attach should include an itsmisa-
tion and explanation of such charges.
-3-
FIFRA Oompliance/Enfor
A-43
Guia
1983
-------
Appendix
Exhibit A-7
Total Penalty
Charges Dots
Show the total amount, through the date of
the Certification of Indebtedness, of any
penalty charges which nay have been assessed
by the agency far debtor's failure to pay
any portion of a debt more than ninety (90)
days pest due pursuant to the Debt Collection
fft Of 1962, P.L. 97-365 $11(e)(2). The
Certification of Indebtedness which you
attach should include an itanization and
explanation of such penalty charges.
Total Mount Duet
Annual Interest
Rate i
SOL (Statute of
Uaitations) Datet
ran it
the total (Grand Total) amount due
on the data through the date of the
Certification of Indebtedness.
ITEM 2:
ran 3t
the rate of annual interest charged
by the agency on the debt.
Show the sase statute of limitations date
which is to be entered at Item 11 of the
can.
THE LBtfiUM
Show the debtor's date of birth. In the
case of a non-beneficiary debtor (e.g., a
representative payee) and the date of birth
of the debtor is unknown, show •Unknown.'1
In the event that the debtor is a corpora-
tion or partnership, show "Not applicable
[corporate/patUiershipl debtor.*
Show the debtor's social security nunber.
In the case of a nan-beneficiary end the
debtor's social security mater 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 nuofeer of the corporate
or partnership debtor is unknown, show
"Unknown."
Show any other nane(s) (alias(es)) used
by the debtor. If the debtor is a sole
proprietor, show the nane 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 proprietorship names an used by the
debtor, or known, show "Not applicable*
or "Unknown."
VTVDA
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-------
Appendix
Exhibit A-7
ITEM lOt
11:
12:
bureau, include the date the debt was
reported and the name, address and telephone
number of the oannercial credit bureau to
which reported.
[Stamping 'Address Correction Requested"
under the return address block on envelopes
mailed to the debtor will alert the U.S.
festal Service to inform the creditor
agency of changes in the debtor's address.
Registered mail with forwarding and
return-receipt requested is also an
effective way to locate debtots. In
addition, the O.S. Postal Service retains
change of address notices for one year
after they have been filed by a patron.]
m the case of a corporate debtor, include
the current residence address of the prin-
cipal of Clears of the oat-potation. Where
there is a legal successor in interest to
the corporate debtor, the sane information
requested in Item S, above, and this item,
should be provided for the successor party
or corporation.
T« OAJM
Briefly describe or characterize the claim
or cause of action (e.g. , •Social Security
Administration benefit overpayment under
O.S.C. S _ •). Describe in particu-
larity the naEure and type of benefit over-
payment, loan default, or other action by
the debtor which gave rise to the claim. As
show in the parenthetical *»»t»T* 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 uwpaimaiL, loan default, etc.
Show the last date (month, day, year) on
which suit can be brought to recover the
claim or debt, i.e., the statute of limi-
tations (SOL) date?
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
7IFBA Cbapllance/EnforceMnt
A-46
r.ft Mmtiol
-------
*J
§
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»* IH ?l
-------
Appendix
Exhibit A-7
IOM 20:
ITEM 21<
ITEM 22i
If the debtor denied the claim, in ttole or
in part, give the date (month, day, year)
of such denial and explain how the debtor's
denial of the claim was made known to the
agency (e.g., letter, telephone call, person-
al interview). Briefly explain the debtor's
position with respect to the claim, if known.
Explain any defenses that the debtor raised
or can be expected to raise with respect bo
the claim and the merits of such defenses.
Attach copies of any agency records docu-
menting the debtor's denial. If the debtor
did not dispute the claim, in Wiole 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 pert, of the claim.
Otherwise, stow 'H» agency response.* If
the claim MBS 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.
S»w the date (month, day, year) of any such
application for waiver, request for recon-
sideration, or appeal. Attach copies of any
documents evidencing such debtor's application
tor waiver, request for 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. Slow the date (month, day, year) of
any such "agency action" and attach copies of
documents 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
•srits 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
(tilted States, as well as any claim for
offset which the debtor may assert.
-8-
FIFBA Compliance/Enforcement
A-48
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-------
Appendix
Exhibit A-7
•Ooeplimentary
dosing- Block:
•Agency Employee
Responsible for
Handling the
daia" Block:
•AttactMnts as
Listed' Blodc:
credited. (Be sure to include the appropri-
ate agency prefix.) [Nate: Please remember
that the amount of tecovery representing
court costs should always be deposited
into Treasury Miscellaneous Receipts Account
No. 00X99, substituting your agency prefix
tor the two zeros in this symbol.]
(ttMn using the "Letter" format] Show the
new, title, coaplete selling address, and
PTS telephone ninber of the agency official
who Mill sign the report.
San the nane, title, complete mailing
address and TOS telephone nu&ber of the
agency employee Mho is seat knowledgeable
of the history, facts and details of the
individual date and Mho is responsible for
answering any questions or resolving any
probleas which soy arise with respect to
the individual claim.
List, all supporting documentation which
is included in the CCLR package. All
documents provided should be legible.
-16-
-------
Appendix Exhibit A-7
Department of Justice Demand Letter
- -M.S. DEPARTMENT OP JUSTICE
:0HIT£O STATES ATTOBHEY
> [Debtor's full name]
>[ Deb tor's mailing address]
>Re: (Name of Agency] Indebtedness
> (Amount of claim].
' >'(Type of overpayment ]
Dear>(Mr./Mrs./Ns.]>(Debtor's surname] :
•
The [Name of Agency] claims that you are indebted to the United
States for the amount shown above. The basis for the claim is
set forth on the enclosed Certificate of Indebtedness. It is the
responsibility of this office to file suit to collect debts owed
to the United States after all efforts by the [Name of Agency] to
collect have failed.
Unless payment in full is received within the next ten (10) days,
we will be compelled to file suit against you in United States
District Court to recover the full amount of the claim. In the
latter event, court coats, United States Marshal's fees and
interest will be added to the amount you now owe. Enforced
.collectixsn can ifaan ;b» jade -toy .the anitad Stata* .Marshal woo
T»ey Ae ordered to . attach and sail .any aon sTamjt 'property you
•have now or may acquire in the future.
Your check or money order for the amount shown above should be
made payable to "Treasurer of the United States' and mailed to
us in the enclosed self-addressed envelope within ten (10) days.
Only your full cooperation and prompt payment of the amount of
the claim will make suit and enforced collection unnecessary.
Very truly yours,
>[Name]
United States Attorney
Enclosure
.JBXHXB
-------
Appendix
Exhibit A-7
United States Attorneys' Offices for Which a
Department of Justice Deaand Letter Should
be Prepared andIncluded in the CCLR Package
Judicial District
Alabama, Middle
Alabama, Southern
Alaska
Arkansas, Eastern
Arkansas* Western
California, Northern
Connecticut
Delaware
Florida, Northern
Georgia, Middle
Hawaii
Iowa, Northern
Kansas
Louisiana, Middle
Mississippi, Southern
Missouri, Eastern
Missouri, Western
Nebraska
Nevada
New Hampshire
New York, Eastern
New York, Southern
New York, Western
North Carolina, Middle
North Carolina, Western
Oregon
Pennsylvania, Middle
Puerto Rico
Rhode island
South Carolina
Tennessee, Middle
Texas, Western
Vermont
Virginia, Western
West Virginia, Northern
City ofHeadquarters Office
Montgomery
Mobile
Anchorage
Little Rock
Port Smith
San Francisco
New Haven
Wilmington
Pensacola
Macon
Honolulu
Cedar Rapids
Tapeka
Baton Rouge
Jackson
St. Louis
Kansas City
Omaha
Las Vegas
Concord
. Brooklyn
Hew York
Buffalo
Greensboro
Asheville
Portland
Scranton
Bato R*y
Providence
Columbia
Nashville
San Antonio
Burlington
Boanoke
Wheeling
[Attachment to Exhibit 8]
FIFRA Ocmpliance/Riforceaent
-------
Appendix Exhibit A-7
Department of Justice Acknowledgment "Comeback Letter'
U.S. DEPARTMENT OP JUSTICE
DHITED STATES ATTORNEY
>[Name]
>[Title]
>[Agency]
>[Mailing address]-
>
Jto* BBcetpt :of [•••• ol Agency] Claia
ytDebtor's full name; LAST NAME, first name, middle name]
>[Agency's file or claim identification number]
United States Attorney's claim number:
Dear> t
This is to acknowledge receipt of the above-referenced claim
which was sent to this office for enforced collection. You will
be advised of the success of our efforts in this regard in due
course. If your future correspondence or other communication with
this office relative to this matter references the debtor's full
• name and our civil claim number above, we will be able to respond
more quickly. Please annotate your file accordingly.
Very truly yours.
>[Name]
United States Attorney
XT '*J
3ma>llance/Enforeewent A—*o Ai-r^^j.ja,,,,*,,*.'! ...too*
-------
Appendix
Exhibit A-7
Department of Justice Deficiency or Declination Letter
U.S. DEPARTMENT OF JUSTICE
UNITED STATES ATTORNEY
>[Nane]
> [Title]
> [Agency]
> [Hailing address]
Ret [Name of Agency] Claim
> [Debtor's full name; LAST NAME, first name, middle name]
> [Agency's file or claim identification number]
Dear> t
Our initial review of the above-cap tioned claim which you recently
referred to this office for enforced collection revealed that
the claim, as forwarded, does not meet the minimum standards
for referral of such claims to the United States Attorney for
litigation. As you know, the Federal Claims Collection Standards
(4 C.P.R. $$101-105) require that certain information be forwarded
to United States Attorneys with each claim.
4
The reason(s) why we consider this claim to be deficient and we
presently decline to enforce collection of the claim through
litigation is (are) indicated below.
_____ Claim was not referred well within the time
•—— limited for bringing a timely suit against
the debtor.
_ Claim was less than $600.
_ Claim did not include the debtor's current
" residence address for service of complaint
'•*•**- and summons.
_____ Claim was not accompanied by credit data obtained
•~~~' within the last six months indicating the present
or likely future availability of assets or income
from which a substantial sum may be obtained by
enforced collection proceedings.
[EXHIBIT 10]
-------
Appendix
Exhibit A-7
^^^__ Claim was not accompanied by a summary and
^^™"" supporting documentation of the actions pre-
viously taken to collect (including agency
demands for payment, personal interview with
debtor) or compromise the claim.
^ Claims Collection U*igatlon fteport not
adequately completed. See Xtem(s) .
Please provide requested information or an
explanation of why you cannot.
__ Other.
Zf you are able to provide us with the above-indicated information
as required by the Federal Claims Collection Standards, then you
should resubmit the claim to us for appropriate action.
-Very truly
>[Name]
United States Attorney
-2-
-------
Appendix
Exhibit 4-7
0. S. ATTORNEYS' BAILING ADDRESS LIST
JUDICIAL DISTRICT
Alabeaa - Northern
Alabaaa - Middle
Alataaaa - Southern
Alaska
Arisen*
Arkansas - Eastern
Arkansas - Western
California - Northern
California - Eastern
California - Central
California - Southern
Colorado
Connectieut
HEADQUARTERS OFFICE
200 Federal Building
1800 fifth Avenue north
Birmingham, AL 35203
tost Office Box It?
Montgomery, AL 36101
fo*t Office Drawer •
Mobile, AL 36601
Federal Building « O.8. Courthouae
701 C Street, Booai C-252
Hail Box 9
Anchorage, AX 99513
4000 0.8. Courthouae
230 north rir«t Avenue
Phoenix, AS I302S
Poat Office Box 1229
Uttle Rock, AR 72203
Poat Office Box 1524
fort Smith, AR 72901
450 Golden Cat* Avenue
San franci»co, CA 94102
3305 Federal Building
650 Capitol Hall
Saeranento, CA 91814
3t2 North Spring Street
Loa Angeles, CA 90012
940 Front Street
Room 5-H-19, O.S. Courthouae
San Diego, CA 92189
1961 Stout Street
Suite 1200
Federal Office Building
Drawer 3615
Denver, CO 80294
Post Office Box 1824
•ew Haven, CT 06908
(EXHIBIT 11)
FIFRA Riwml 1 »•«•« It
-------
Appendix
Exhibit A-7
JUDICIAL DISTRICT
Delaware
District of Colunbia
Florida - Northern
Florida - Jliddl*
Florida - Southern
Georgia - Northern
Georgia - Middle
Georgia - Southern
Hawaii
Idaho
Illinois - Northern
HEADQUARTERS OFFICE
J. Caleb Boggs Federal Building
844 Ring Street, Room 5001
Vilaington, DE 19801
2800
0. 8. Courthouse
3rd * Constitution Avenue, N.W.
•ashington, DC 20001
100 North Palafox Street
Booa 307
Mnsacola, Ft 32581
•XiaberlaJcs Building
SOO Sack «tr**t, .Booa 410
FL 33602
155 South Miami Avenue
Miaai, FL 33130
Bichard Russell Building
Booa 1800
75 Spring Street, S.«.
Atlanta, GA 30335
lost Office Box O
•aeon, GA 31202
lost Office Box 8999
Savannah, GA 31412
"••Bite '<903~Hy "•W "Building
238 O'Bara Street
Agana, GO 96910
C-242
MM Federal Building
Box 50183
300 Ala Moana Boulevard
Bonolulu, HI 96850
693, .Jaderal -Building
'0.37
Ewett McKinley DirJtsen
Building, Booa 1500 8
219 S. Dearborn Street
Chicago, n. 60604
-------
Appendix
Exhibit A-7
JUDICIAL DISTRICT
Illinois - Southern
Illinois - Central
Indiana * Northern
Indiana - Southern
Iowa - northern
Iowa - Southern
Kansas
Kentucky - Eastern
Kentucky - western
Louisiana - Eastern
Louisiana - Middle
Louisiana - tfestern
Mala*,
Maryland
HEADQUARTERS OFFICE
Boon 330
750 Missouri Avenue
Bast St. Louis, IL 62202
Post Office Box 375
Springfield, IL 62705
Federal Building, Room 312
507 State Street
Hammond, IN 46320
274 0. 8. Courthouse
46 Bast Ohio Street
Indianapolis, IN 46204
Post Office Box 4710
Cedar Rapids, IA 52407
122 0. S. Courthouse
E 1st and Walnut Street
Des Koines, IA S0309
444 Quincy street
TOpeka, KS 66683
Post Office Box 14SO
Lexington, KY 40501
OSfO « Courthouse, Room 211
601 West Broadway
Louisville, KY 40202
Bale Boggs Federal Building
SOO Camp Street .
Hew Orleans, LA 70130
3S2 Florida Street
Baton Rouge, LA 70801
Room 3B12
Federal Building
SHreVeport, LA 71161
P. 0. Box 1588
Portland, MB 04104
8th Floor, O. S. Courthouse
101 W. Lombard Street
Baltimore, MD 21201
-3-
FIFRA Gcmpllance/Eaforceaent
A-ftA
-------
Appendix
Exhibit A-7
JUDICIAL DISTRICT
Massachusetts
Michigan - Eastern
Michigan - Western
Minnesota
1 -SB ippf • -~
Mississippi - Southern
Missouri - Eastern
Missouri - Western
Montana
Nevada
New Hampshire
New Jersey
»*>
New Mexico
HEADQUARTERS OFFICE
1107 John W. McCormack Fed. Bldg.
OSPO ( Courthouse
Boston, MA 02109
817 Federal Building
231 W. Lafayette
Detroit, MI 48226
399 Federal Building
Grand Rapids, MI 49503
234 0. S. Courthouse
110 South 4th Street
Minneapolis, MN 55401
;>o«t \0«fie« Orawvr 866
Oxford, MS 38655
Post Office Box 2091
Jackson, MS 39205
U.S. Court ( Custom House
1114 Market Street, Room 414
St. Louis, MO 63101
549 0. S. Courthouse
811 Grand Avenue
Kansas City, MO 64106
Post Office Box 1478
Billings, MT 59103
•<»o»t'OfflWB«« 1778, T3TS
Omaha, NE 68101
Box 16030
Las Vegas, NV 89101
Federal Building
Concord, NH 03301
Federal Building
-fioosi 502
»70 *ro*d Street
Bewar*, NJ 07102
Post Office Box 607
Albuquerque, NM 87103
-4-
-------
Appendix
Exhibit A-7
JPDICIM. DISTRICT
Haw York - Northern
Hew York - Southern
New York - E**t*nt
Bsw York - western
North Carolina - Eastern
north Carolina - Middle
north Carolina - Western
North Dakota
Ohio - Northern
Ohio - Southern
Oklahoma - Northern
Oklahoma - Eastern
Oklahoma - Western
Oregon
HEADQUARTERS OFFICE
Post Office Box 1258
Federal Building
Syracuse, NY 13201
One St. Andrews Piaxa
Hew York, NY 10007
0. S. Courthouse
225 Cadaan Plaza Bast
Brooklyn, NY 11201
S02 U. S. Courthouse
Court i Franklin Streets
Buffalo, NY 14202
Post Office Box 2689?
Raleigh, NC 27611
Post Office Box 1858
Greensboro, NC 27402
Post Office Box 132
Asheville, NC 28802
Post Office Box 2SOS
Fargo, NO S8108
Suite SOO
1404 East Ninth Street
Cleveland, OR 44114
220 OSPO & Courthouse
5th i Walnut Streets
Cincinnati, OB 4S202
Room 460
0. S. Courthouse
333 West Fourth Street
Tulsa, OR 74103
Post Office Bos 1009
Nuakogee, OK 74401
Room 4434
0. S. Courthouse i federal
Office Building
Qklahoaa City, OK 73102
312 0. S. Courthouse
620 S.w. Main Street
Portland, OR 9720S
T*! Hf «•*•-*-
-------
Appendix
Exhibit A-7
JUDICIAL DISTRICT
Pennsylvania - Eastern
Pennsylvania - Middle
Pennsylvania - western
Puerto Rice
•bode Island
South Carolina
South Dakota
Tennessee - eastern
Tennessee - Western
Texas - Northern
Texas - Eastern
BEADQPARTERS OPPICE
3310 0.8. Courthouse
601 Market Street
Independence Nail Nest
Philadelphia, PA 19106
Post Office Bos 309
scranton, PA 1SS01
633 OSPO ft Courthouse
7th Avenue ft Grant Street
Pittsburgh, PA 15219
Federal Office Building
Boosi 101
Carlos ••*. Cbardoa .street
•ato Bey, JK .00918
Post Office Bex 1401
Providence, XX 02901
Post Office Box 2266
Columbia, SC 29202
Post Office Box 1073
Pederal Building A Courthouse
400 South Phillips Avenue
Sioux Palls, 80 57102
Post Office Box 872
Enoxville, TO 37901
•79
Nashville, TB 37203
1026 Pederal Office Building
167 North Main Street
Memphis, TN 38103
310 0. S. Courthouse
10th t Laser Streets
Port Worth, TX 76102
Offlm :fxn S1129
«omrton, TX T77OT
Post Office Box 1510
Beauaont, TX 77704
-6-
1000
-------
Appendix
Exhibit A-7
JUDICIAL DISTRICT
Texas - Western
Dtah
Vermont
Virgin Islands
Virginia - Eastern
Virginia - Western
Washington - Eastern
Washington - Western
West Virginia - Northern
West Virginia - Southern
Wisconsin - Eastern
Wisconsin - Western
Wyoaing
N. Mariana Islands
HEADQUARTERS OFFICE
John H. Wood, Jr. Federal Bldg.
655 East Durango Boulevard
San Antonio, TX 78206
200 Post Office s Cthse. Bldg.
350 South Main Street
Salt Lake City, OT 84101
Post Office Box 570
Federal Building
Burlington, VT 05402
Post Office Box 1440
St. Thomas, VI 00801-1440
2nd Floor
701 Prince Street
Alexandria, VA 22314
Post Office Box 1709
Roanoke, VA 24008
Post Office Box 1494
Spokane, WA 99210
3600 Seafirst 5th Avenue Plaza
tOO Fifth Avenue
Seattle, HA 98104
Post Office Box 591
Wheeling, WV 26003
Post Office Box 3234
Charleston, WV 25332
330 Federal Building
517 East Wisconsin Avenue
Milwaukee, HI 53202
Post Office Box 112
Madison, WI 53701
Post Office Box 668
Cheyenne, WY 82003
e/o D.S. Attorney's Office
Post Office Box I
Agana, GO 96910
-7-
-------
Appendix
5 Expert Witnesses
Selection of Witnesses
Administrative, civil, and criminal enforcement actions sometimes require
the presentation -.of 'expert testimony on behalf of the Agency. Witnesses
should be chosen for their direct knowledge of the circumstances
surrounding the suspected violation. Below follows some guidelines to aid
the EPA attorney in choosing witnesses for Judicial proceedings.
Headquarters Witnesses
Many of the records pertaining to, and technical experts with knowledge of,
regulations concerning pesticide products are located within the
Registration Division at Headquarters. Witnesses from the Registration
Division are available to testify on:
,» Ihe xe^lstTxtion «txtoB 4>f * pesticide;
• Whether a product is a pesticide or a device subject to FIFRA;
• Agency interpretations of labeling statements, directions for use,
etc.; and
• The significance of a discrepancy as It relates to the sample's
rj^ ox vfcoxicity.
Regional Witnesses
Technical experts in the Regions will generally testify as to:
• Inspection procedures and the facts and findings anrr
: )j^mP^fc^tti3fcKjSB^IjiO^^X2 * ^isV^l^l
• Programmatic procedures such as Inspection schemes, penalty
calculations, FIFRA violations, etc.
FIFRA unpUance/Sitorceaent A-69
-------
Appendix Expert Witnesses
Other Government Witnesses
EPA personnel often work with other Federal government personnel In
developing casework, either through interagency agreements (lAGs) or
memorandums of understanding (MOUs). Other government employees of
agencies such as the Food and Drug Administration, the U.S. Department of
Agriculture, or the Fish and Wildlife Service may be called upon to testify
concerning:
• Test procedures, findings, and conclusions related to pesticide or
device studies; and
• Information collected during an investigation but referred to EPA
for enforcement.
Contractor Witnesses
Expert witnesses will occasionally have to be utilized under contract to
testify as to:
• Test procedures, findings, and conclusions related to pesticide or
device studies they have conducted; and
• Technical matters for which there are no Agency experts available
for testimony.
Procedures for Requesting Witnesses
All requests for witnesses who are not regional personnel should be made in
writing to the appropriate HQCDO. The HQCDO will, in turn, arrange for the
proper witness to represent the Agency in court and will provide a status
of the witness's availability to the requesting Region.
Appearing as j^Witness
Vigorous enforcement programs will increase the probability that an
Inspector will be called upon to testify In court. By the time a case has
entered the judicial system, Inspectors and case proceedings personnel will
have invested many hours In developing a sound program for prosecution.
When a witness is called to testify, it is imperative that quality
testimony is provided and a professional Image is projected in the
courtroom.
HJPHA Compliance/EnforcementA-70 Guidi
-------
Appendix Expert witnesses
A witness, to be effective, must make statements that are understandable
and must have them accepted as truth by the judge or Jury. In addition to
being truthful and honest, a witness* principal aim should be to make a
favorable Impression on the court. The guidelines presented In this
section will help prepare the witness to be effective and credible.
Personal Appearance and Conduct
Dress Is Important. A well-groomed, .neatly attired witness makes a more
favorable impression in the courtroom. Conduct should reflect the solemn
nature of the Judicial proceedings. In order that a witness presents the
appropriate image, the following considerations should be kept in mind at
all times.
Come to the courtroom prepared. Be thoroughly familiar with your facts.
Pertinent time and dates should be checked. Order all documents and
exhibits so *h»t*. tpgfiTn^my will fop . pr^m* pt-ed -withQvt' fumbling* Be on »•<•«*»
when court opens -mad be available immediately when called to testify.
Try to avoid:
• Doing anything that may attract attention to you. Make yourself as
inconspicuous as possible;
• Sitting in groups with more than two or three colleagues. Spread
out in the courtroom;
• Whispering or talking to another person or causing any disturbance
in the courtroom;
• Showing incredulity or surprise at any testimony given from the
witness stand or at statements made by the defense attorney. Avoid
expressing approval or disapproval of any testimony by nod, glance,
or other gesture;
• Having anything in your mouth (such as gum, toothpick, tobacco,
candy, or food);
• Discussing the case with the defendant or the defending attorney;
• Talking to the Jurors or discussing the case within their hearing;
• Consulting with case personnel while court is in session, unless
-do :'-'S0~j '
• Holding conversations with principals or witnesses for the opposing
side. If conversations are unavoidable, confine remarks to matters
other than the trial.
OompJ^ance/aaroxcement A-/I Guidance *««««• i 1983
-------
Appendix Expert Witnesses
Witness Stand Technique
When called to the witness stand, unless previously sworn, go directly to
the desk of the Clerk of the Court to be sworn. Take the oath in a solemn
manner. Then proceed to the witness chair. If you have a long or unusual
name, give a card or paper with the correct spelling to the court
stenographer. Assume and maintain proper posture, bearing, and demeanor.
Sit erect, but do not appear stiff or tense. Attempt to project an image
of poise and self-control.
Speaking. Speak in a clear, distinct, and well-modulated voice. When
addressing a Jury, look at and speak distinctly to them. Speak loud enough
so that the farthest juror can hear you*
Use simple language. If the subject is technical or scientific, reduce the
terminology to an understandable level or give definitions of terms used.
Avoid Idioms or language particular to your profession or to the Agency.
Notes. You may bring notes with you to the witness stand. However, do not
bring your field notebook or any other documents you do not want the
opposing side to examine. They have a right to see any notes you bring to
the witness stand.
Do not hesitate to ask permission to refer to your notes when testifying,
provided your notes were made at the time of, or immediately after, the
event about which you are testifying. You should not be embarrassed if you
cannot recall exact details without referring to your notes. Try not read
long passages verbatim from your notes.
Answering Questions. Wait until a question is asked in its entirety before
beginning to answer. Never attempt to answer a question you do not fully
understand. Ask that the question be repeated or rephrased if its meaning
is not clear. If you do not know the answer to a question, say so. Do not
try to cover up a lack of knowledge of a particular subject.
Questions should be answered verbally—do not nod assent or shake your
head. Answer only what is asked fully and to the point without
volunteering information. Do not "spar" or attempt to match wits with the
questioning attorney.
*&*.
Be truthful, and answer all questions frankly, factually, and confidently.
Try to limit your testimony to those facts about which you have first-hand
knowledge. Anything else may be considered hearsay. Do not exaggerate;
state the facts accurately.
Do not express opinions or conclusions unless you are testifying as an
expert witness. You cannot assume expert knowledge in a field unless you
are an expert by reason of your training and experience. If questioned on
a subject beyond your scope, admit that the subject is outside your field
or knowledge.
A— 2
-------
Appendix Expert Witnesses
Try not to become listless or "dead pan" In your effort to appear Impartial
and unbiased. Be natural, candid, frank, and "alive." Conversely, you
should not appear impatient or overly anxious to testify. Attempt to
minimize nervous tendencies, such as arranging clothes, notes, etc.
Do not speak to the judge unless he or she asks you a question.
Testifying Under Direct Examination
In a proceeding arising out of an Agency Judicial enforcement action,
direct or1 re-direct examinations will generally be conducted by an EPA
attorney or a U.S. Attorney. The initial questions he or she will ask will
seek to establish:
• Your identity, occupation, and qualifications; and
• The relevancy of your testimony to the proceedings.
.Subsequent questions will allow you toirelate your testimony to the court.
In order to facilitate this questioning, you should:
• Try to give testimony in chronological order. Reveal your first
connection with the case. Then give facts in the order they
occurred. Your testimony should be memorized, if possible.
• If the opposing attorney objects to a question, do not try to get
in an answer before the judge has ruled whether the question is
proper.
• Do not try unnecessarily to help the questioning attorney. He will
pair fA^if j^paj -^uestioBfl .Xjo .bring vOut • fvrttiT -details to complete
your testimony.
• Be able to identify the defendant.
Testifying Under Cross Examination
Cross examination is the questioning of witnesses by attorneys representing
to
Do not be afraid to admit that you discussed your testimony with government
attorneys. There is nothing Improper In a practical discussion of your
testimony with the attorneys.
The opposing counsel may attempt to intimidate you by attacking your
qualifications or length of service, or by emphasizing errors you have
made. Remain calm and answer any question asked unless an objection is
raised and sustained. If the opposing counsel attempts to confuse you with
rapid questions, answer the questions deliberately and at a comfortable
rnapllnnrf/rfrirnrM •< ill A-73 Guidance »i«*«Ji 1983
-------
Appendix Expert Witnesses
pace. Ask the attorney to repeat or rephrase any question that is unclear
or confusing. If asked a double or "two-pronged" question, ask the
attorney to restate it, or carefully answer each part separately.
Wait several seconds before you answer a question put to you in cross
examination in order to give the U.S. Attorney an opportunity to object.
Avoid, however, undue delays in answering. If an objection has been
raised, do not answer any questions until a ruling on the objection has
been made.
Do not lose your patience or temper while testifying. A cross-examining
attorney often deliberately baits an Irascible witness to anger the
witness. Try to remain calm and unruffled. Do not become argumentative
with the cross-examiner if your testimony is interrupted or for any other
reason. Beware of questions to which the cross-examiner demands a "Yes" or
"No" answer if such an answer will not reveal the entire truth. These are
often leading questions. If a simple yes or no does not properly answer
the question, inform the cross-examiner that the question cannot be so
answered. If the cross examiner should misquote any of your earlier
testimony, you may correct the misquote before answering the question.
If you make an error while testifying, correct it at the first
opportunity. If you discover the error after you have completed your
testimony and have been dismissed, discuss the matter with the U.S.
Attorney.
You may be asked whether you regard certain persons In the field about
which you are testifying as recognized authorities. This Is often
preparatory to asking you whether you agree with certain statements that
those authorities have made. If your answer is no, that you do not
recognize them as authorities, that line of cross-examination cannot be
pursued. Unless you definitely have heard of the named persons and are
familiar with their works and do recognize them as authorities, do not
expose yourself by saying that you so recognize them.
Proper Conduct During Recess and After the Trial
During recess, continue to maintain the same demeanor as in the courtroom.
Do not engage^ln loud conversation or joking, especially about the
proceedings. Be as discreet as possible when making any comments that
might be overheard.
After the trial, continue to conduct yourself in a manner that will bring
credit to you and to the Agency. Make no public display of elation or
disappointment over the outcome of the trial. If there is occasion to
speak to the defendants, be courteous regardless of their demeanor.
uompjaance/jsazorcement A-/t Guidance Manual
-------
Appendix
6 Penalty Policies
The following items are used by the Agency in establishing its penalty
policy guidelines:
• Guidelines for the Assessment of Section 14(a); Citation Charges
for Violations
• Guidelines for Enforcing the Child-Resistant Packaging Regulation
• Memorandum (22 Apr 1975)—Interim Deviation From Civil Penalty
Assessment Schedule
• Memorandum (11 Jun 1981)—FIFRA Enforcement Policy; Interim Penalty
Guidelines
compliance/Enxorceaent A-/3 Guidance m»nnmi 1983
-------
Appendix - ?«nalty Policies
A-76 Qa±d***f* Mmnal 1983
-------
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-------
Appendix Gaid»T»"gq for Civil Penalty Aaaessaent
and propoalaf to a*M* a atvll paaalty wfeico
abate** opntaln*d la tb* «*MHplilnt
(2) What cmuttttUe* «• tad**** „ _
•at* cAarpe. A Mparat* dvfl paaatty aaall
••4 tor oacb **olatlaa_of tb* Act
failure to act) of tb*
(ft)
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taaedaa at (1) UM
typ* «f'oM «B-
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•try «B u* eueialwJat. Mr tb*
• - _ - of
p*Balty fgr op*dA6ati0A IB
at will nonantr tb* esni
i l*Htloa U of tbto docu-
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ttu gravity of Ow vlouaoa and (>) tba tb*
aauetpate* vanou* eoasbtaauoaa of
two taetora. laeb tat*r**euoa of vtoUUaa •"*
Cravtty and bualB**§ *!•* cofivtttute* a o*ll C"m^ _
of tb* matrix, witbia oach e*U to a dollar ^f
aaaoaat r*pr***ntlat tb* penalty ba*a Ogure.
Tatt BaMagttr* coaatitatat tb* dollar •P*"1
OBMB&t fnuu waicb ttt* ctvfll poaalty pro* ^^^ *
>Tau penalty artudal* do** not apply to
private applicator* and u*m (aoa tnrliHHny
•alera. retaUen. or otbor dictHbuton.)
VOL », NO. 14*_WCONCSOAT, JWT 31. 1*74
VTVD* r?«—«!•««*-.—
-------
Appendix
for Civil Penalty Aflseseaent
penalty
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tM BO« »pp»oprtM* BMT otetfH «teU h* MM*
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nomn, vot. »t, NO. 14*-WMNMOAT, AWT si, iff4
A-79
-------
Appendix
Guidelines for Civil Penalty Assessment
SECTION II- C'fIL FI'^L
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-------
Appendix
Guidelines for Civil Penalty Assessment
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-------
Appendix
for Civil Penalty Aasessaent
CFflCACT VIOLATIONS
1
•
2*
Section One: Disinfectants
Ineffective D1sinf*cttats
Section
I«f
' |
ft. HBSpiui use
1. am Mitfttr s.
jMreus wt J.
2. Ktlls only one of
tt* •>•»• listed
•raaMvn
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1. M1UM1UMT Of
•MMtoM
Z. Mils only ene or
tfet «•**• listed
•mnlsas
H Ftttlft to Kill TP1CftOp£jJpfl
TUB; tedentlelOi
T>^«- iri/ir«r '.^.rT44JLT^ii.^i^iv
f»^ll-rTS^TlirA^ifT^*r7^^l^l^lll*ll^l^
I 11 III
MOO
4000
MO
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280
MOO
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W
'•25
700
i
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<
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i
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1375
IMd
n v
•000
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21 2S
2>80
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IS*0
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MOO
2500
2MO
sow
ZBBO
1. Mo or Disposal *f 4 *tst1e14« 1st • NUHMT XansalMont irlta Its Ubellns.
i ii HI nr v
2.
A. AdvsrM trreew
(H«tily Probable
1. MverM Errecu
UflfcflOWl
C. A*>*rs* Effects
Hot *rotable
MO
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120
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700
300
27M
1S40
MO
«M *P DispOMl Contrary • the hrovlsioas «f W Upcriswrtal VM Nrnlt
I • 11 HI
u Movi*d9* (of tne
penrlt)
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neralt)
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*BD*rlM*Ul UM
MO
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1290
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1020
rr
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{Action My alHSys be taken aoafnst tne n»M*r of tt* *sp*rtt*ntai UM
ptnMU)
I 1
-------
0»
01
02
Of
O9
as
Off
06
33
'.'. Sup S*Je. us* <• loio.il
Order
t II
lit IV V
A. "Violation of a sup sale.
Use or Rcneval Order SOOO SOOO
I. failurt U provide nwits
and addresses of recipients
of products believed to bo
In violation of the Act for
oirposts of Issuing a Stop
Sale. Use or tonoval Order SOO 1250
4. Violation of • Suspension Order
X 300
S. Violation of a Cancellation Order
I II
*,__ BWMiedao of the TJnJi
B. M Mowioaae of tn* i
•. Teats on HUM Mngs
r SOO 1Z»
rder 100 zw
I 11
SOOO
2780
SOOO
4250
5009
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•60
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1ZOO
m • nr 'v
'Ufl
•250
B50
u oa
m nr v
Is* of pesticide in tests
on nuaan beings tn violation
of the Act SOOO SOOO
1. looks and Records
IBSCniAnTOUI VIOLAT19
I II
SOOO
1000
SOOO
B
in nr v
A"T"~Tallur* to naintain
books and- records as
required under section 8'*) 420 1050
Irrailur* u allow
Inspection of books
and records required
to bo Maintained
420 1090
2. ProdMCtlen and Distribution Data
t 11
aio
2310
3570
• J570
4200
4200
HI nr v
roiTuro u swit required
reports of production or
distribution data required
ynder section 7(cl SOO 1250
3. 4o»poct1on of establishments; Sanpl* Collection
t II
2788
4290
SOOO
tn nr T
Failure to allow inspection
of on esublishnent or refusal
St nil** sMollna of < oesticid* 500 1290
4. Failure to leglster Producer CstabllsbMnt
I " II
2790
4290
^^
HI Tf V
A. .luwM'ceee of ftC9istration
Rc^ui rrr.cn t 420 1050
VTlb Knut.'IcJfC or tne Regis>
tratisn P.cou*r«n
-------
Appendix
for Civil Penalty Assessaent
5. Falsified All or Part of a* Application
t ti TTT nr
*. a*ji*tr«tion Application
I. UocrtMnuJ UM r*rm\t
A:aHcation
§r tcn'ldentiii itv Status
. ^vBBiuoa »al»o Production
Oau
500
500
IZU
IZM)
12SO
Z750
W50
nso
4ZM
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4HO
V
icco
fOOO
5000
H
nr
* f*l*«
500
5000
> or* o liosnir of srinor violations «etefr oojr to dooood not serlovt onougb. steading
alono. to IBM-rant tto osminont of any civil oonalty. l» tto following interns, pi " "
tto M8l1e intorost «uU to sonrod tnorooy. tto Aooney toy dotonrtoo not M assoso a
U
17
(fl
no
tis
1. In|r«d1«Bt
coat 11 ooi.
not ippiir M too froo* ooaol of tto
tote
X. Tto ton -Inort Inorodlonf mt loss •ro«lnoot>ir dlspUyod tnu tto torn
•kctlvo Inorodlon'.
>. Utol follod to taor roflstrotloo OMOBST.
4. Utol failed to toor tto inquired sUtevM of Mt wight.
ft. Utol foiled to boor now. ^rand. or UoUonoit eador «n1cb tto oroouct
mt sold. ^^
ITT
HMro cnirgo nueaor 3(E9) «ppe*n
1o cooMMtlon «1tb My two of tto
ottor afaovo ehtroos. *"~
120
300
MO
IBM i itn
. FXFRA Com.ll.ano0/i
-------
Appendix
Gold**! lues for Civil Penalty Assessment
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Appendix finld*'M'H«t-* for Civil Penalty Asses
TUVA. Co«o liance /Enforcement
-------
Appendix CRP Regulation
Guidance for Enforcement
of the
Child-Resistant Packaging Regulation
The Child-Resistant Packaging (CRP) regulation1
(44 Federal Register 13019) was promulgated March 9, 1979
pursuant to section 25(c)(3) of the Federal Insecticide.
Fungicide and Rodenticlde Act (FIFRA). Since the Enforcement
Criteria of the FIFRA Case Proceedings Manual, the Citation
Charges for Violations of the FIFRA, As Amended (39 Federal
Register 277.21) and the Guidelines for the Assessment of
Civil Penalties Under Section 14(a) of the FIFRA (39 Federal
Register 27711) wer> written prior to the CRP regulation,
they do not Incorporate guidance for the enforcement of the
CRP regulation.
The Pesticides and Toxic Substances Enforcement Division
(PTSED) Is Issuing this guidance outlining additions and
modifications to the above documents to facilitate enforcement
of the CRP regulation by the Regions.
Part I of this guidance deals with new enforcement criteria
to be added to the Case Proceedings Manual.
Part II of this guidance deals with other changes to be
made to the Citation Charges In the Case Proceedings Manual,
and to the Guidelines for the Assessment of Civil Penalties
Under Section I4(a) of the FIFRA, also found in the Case
Proceedings Manual. One charge 1s added and another expanded,
and several penalty matrices are added.
l. A summary of the requirements of the CRP regulation may
be found In the document. "Strategy for the Enforcement
of the Child-Resistant Packaging Regulation Pursuant
to FIFRA.•
FIFRA Coapllance/Enfor
-------
Appendix CRP Regulation
-2-
Part I: Use of .tew Enforcement Criteria
Explanation of Mitigating Circumstances In Enforcement Criteria
•.En,for,c»m«nt -cMterl a 1n .tht^Cas* Proceedings Manual
Indicate the appropriate level of enforcenent action for
particular violations of FIFRA. Until December 31. 1981,
PTSED's policy regarding the appropriate level of enforcement
action for violations of the CRP regulation will take Into
account the following two mitigating circumstances:
0 Registrant's lack of knowledge of the CRP requirements.
0 Registrant's good faith efforts prior to March 9. 1981
to comply with the CRP requirements.
;*ft«t -0»c««t«r 31 , W81 , -r*gtst rents can ~r«a^ona'bly te expected
to have knowledge of the CRP requirements, and can reasonably
be expected to have products In CRP despite delays or problems.
The PTSEO recognizes the following circumstances as
evidence of knowledge of the CRP requirements:
9 So«e, but not all. products are 1n CRP.
0 Registrant commented on CRP proposed regulations.
9 Registrant contacted EPA regarding CRP requirements.
• Registrant filed for an exemption.
cent r4ct«d tritA xp*ck»g^ti g «*nuf ae tu r* r
"for t&P closures or .
• Registrant contracted or began actual testing of
toxlclty or package effectiveness.
The PTSED recognizes that the following circumstances
could be evidence of good faith efforts on the part of a
registrant to comply:
• Registrant contracted w1tJ)r^JCxjg ins manufacturer
^f«rCTP.cl«sor«»-»r\>«e*aifl»s prior taHarcli 3, '1981,
• Registrant contracted or began actual testing of
toxlclty or package effectiveness prior to March 9,
1981.
-------
Appendix CRP Regulation
-3-
Use of Enforcenent Criteria
If a registrant subject to the CRP regulation Is found
to be in violation, Regional enforcement personnel1 should
determine If either of the above mitigating circumstances
exists. After determining the applicability of mitigating
circumstances. Regional enforcement personnel should refer
to the Enforcement Criteria (See p.5} for the appropriate
level of enforcement action.
When cither of the mitigating c1rcunstances apply,
Regional enforcement personnel shall exercise prosecutorial
discretion that 1s conditional upon submission and approval
of a Compliance Schedule. Regional enforcement personnel
shall Issue a Notice of Warning (See Appendix 1), requiring
the registrant to submit a Compliance Schedule within twenty
(20) days of the Notice of Warning.
When neither mitigating circumstance applies. Regional
enforcement personnel shall assess a civil penalty, but
shall also exercise prosecutorial discretion by not Issuing
a Stop Sale, Use, or Removal Order. This exercise of pro-
secutorial discretion 1s conditional upon submission and
approval of • Compliance Schedule. Regional enforcement
personnel shall explain in the letter accompanying the
Notice of Civil Complaint and Notice of Opportunity for
Hearing that the registrant must submit a Compliance Schedule
within twenty (20) days of the letter.
Explanation of Compliance Schedule
Regional enforcement personnel shall negotiate a
Compliance Schedule with the registrant, and shall approve
or disapprove the Schedule within 45 days of the date of
the Notice of Warning. Enforcenent personnel shall notify
the registrant that the Compliance Schedule has been received,
and shall request further Information If needed. Registrants
should respond to requests for Information as soon as possible
to meet the 45 day deadline. Additionally. Regional enforcement
personnel may wish to contact the Registration Division's
packaging expert, Rosalind Gross at 8-557-7780, for assistance
In determining a time frame for compliance 1n the case of '
uncertainty or dispute with the company. Afttr enforcement
personnel approve a Compliance Schedule, they shall forward
a~*£py of the Schedule to the Compliance Monitoring Branch
of PTSEO.
Regionalenforcement personnel are expected to handle case
development and legal matters. States, who are conducting
compliance Monitoring activities. In most cases do not
currently regulate child-resistant packaging of pesticides.
CoaDliance/Eaforceaent A=92 \ aild«nr* tfemuQ
-------
Appendix CEP Regulation
-4-
The Compliance Schedule should show a timetable for
achieving compliance within, at most, 6 months of the date
of the Notice of Warning. However, compliance should be
achieved no later than December 31, 1981, even 1f this
requires a timetable of less than 6 months. Additionally,
the Compliance Schedule should list names of companies or
organizations that will be assisting the registrant In
testing toxldty or package effectiveness.
When registrants fall to negotiate a Compliance Schedule, or
fall to meet their Compliance Schedule, Regional enforcement
personnel'wl 11 no longer exercise prosecutoMal discretion. Such
registrants are still In violation of the CRP regulation If they
continue to release for shipment products which require CRP but
• re not 1n CRP. Without the exercise of prosecutoMal discretion,
such violations are subject to a civil penalty assessment and
Stop Sale, Use, or Removal Order (See Part II: Violation 1:
M1sbrand1ng, p.7, for an explanation of the mlsbrandlng violation),
Regional enforcement personnel nay grant extensions to
Compliance Schedules If the registrant can present a reasonable
explanation of problems or delays arising in efforts to comply.
No extension shall be granted to a Compliance Schedule
allowing noncompllance to continue past December 31, 1981,
unless approved by PTSEO. Requests for extensions past
December 31, 1981, with a detailed explanation of the need
for. the extension, oust be made to the Director of PTSED.
Exception to Enforcement Criteria
Prior to Inspection, a registrant may volunteer the
Information that .Its product, which 1s subject to CRP, is
not 1n compliance. If the registrant made a good faith
effort to comply prior to March 9, 1981, the Region should
require the registrant to submit a Compliance Schedule.1
If the registrant did not Make a good faith effort to comply
prior to March 9. 1981, the Region should assess a civil penalty
and require the registrant to submit a Compliance Schedule.2
If however, the registrant falls to negotiate or falls to
meet a Compliance Schedule, the appropriate civil penalty and Stop
Sale, Use. or Removal Order shall be Issued 1f they are releasing
for" shipment products that require CRP but which are not In CRP.
T.me circumstances are similar to those described 1n enforce-.
.. ment Criterion B, so a similar level of enforcement action
Is taken. However, the Notice of Warning Is not Issued.
2. The circumstances are similar to those described In enforce-
ment Criterion C, so a similar level of enforcement action 1s
taken.
-------
Appendix CRP Regulation
-5-
Llst of Enforcement Criteria
The following Enforcement Criteria are In force prior
to December 31 . 1981 .
A. Registrant did not know of the CRP regulation.
Level of Action : Notice of Warning and Establishment
• of a Compliance Schedule.
B. Registrant knew of the CRP regulation, did not comply
with the CRP regulation prior to the March 9, 1981
compliance date, but nude a good faith effort as of
9, 1981 to comply.
Level of Action; Notice of Warning and Establishment
or a compliance Schedule.
C. Registrant knew of the CRP regulation, did not comply
with the CRP regulation as of the March 9, 1981
compliance date, and did not make a good faith effort
as of March 9, 1981 to comply.
Level of Action; Notice of C1v1l Complaint and Notice
of Opportunity for Hearing (Refer to the Civil Penalty
Assessment Schedule In Part II of this document) and
Establishment of a Compliance Schedule.
0. Registrant failed to meet Compliance Schedule
established pursuant to Enforcement Criteria A, B, or C.
Level of Action: Notice of Civil Complaint and Notice
of Opportunity for Hearing (Refer to the C1v11 Penalty
Assessment Schedule 1n Part II of this document) with
a Stop Sale-, Use, or Removal Order.1
A Stop Sale, Use. or Removal Order shall apply to products
1n violation and to all products released for shipment
until compliance Is achieved.
FIFRA Compliance/EnforcementA^94"Guidance Manual 1983.
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Appendix CRP Regulation
-6-
After December 31, 1981, all registrants whose pesticide
products are subject to the CRP regulation must be In com-
pliance. Only one level of enforcement action Mill be appro-
priate.
The following Enforcement Criterion 1s In force after
December 31, 1981:
Registrant did not comply with the CRP regulation.
level of Action. Notice of Civil Complaint and Notice
• of Opportunity for Hearing (Refer to Civil Penalty
Assessment Schedule 1n Part II of this document) with
a Stop Sale. Use, or Removal Order.
Multiple Assessment
Regional enforcement personnel shall Issue.a civil
complaint containing civil penalty assessments for each
registered pesticide product found to be In violation. For
Instance, one registrant may manufacture seven products,
five of which are subject to the CRP requirements. If all
five subject products are not 1n CRP, then a civil complaint
with five counts of nlsbrandlng shall be Issued, each being
assessed a penalty.
Additionally, there are several requirements under the
CRP regulation. Each requirement that a registrant falls
to comply with will be assessed a penalty. (See Hypothetical
Case 2. p.16).
Covpliance/lsiiorceBent A-95
-------
Appendix CRP Regulation
-7-
Part ri: "Ct-'taftxw-'-Ctwggs. and
the Civil Penalty Assessment Schedule
The violations of the Child-Resistant Packaging (CRP)
regulation fall Into the following five categories:
1. Mlsbrandlng (Not 1n CRP}.
2. Failure to file amended registration and certification,
3. Failure to maintain records of toxldty and package
testing data.
4. Failure to submit records upon request to EPA.
5. Falsification of amended registration, certification,
toxldty testing data, and/or package testing data.
This part of the guidance takes each violation category
and explains the changes or additions that must be made to
the charges cited In a complaint and to the Civil Penalty
Assessment Schedule.
Violation 1; Mlsbrandlng.
A. Modifications of Charges
The FIFRA §2(q)(l)(B) states that a pesticide product
1s mlsbranded If:
"...It 1s contained In a package or other container or
wrapping which does not conform to the standards
established by the Administrator pursuant to FIFRA
§25(c}(3)."
The distribution of products subject to the CRP requirement
1n packaging that 1s not child-resistant after March 9. 1981
constitutes mlsbrandlng under FIFRA §12(a) (1)(E). The current
11st of charges does not cite this specific mlsbrandlng
violation.
FIFRA Cm^pl < aTH*t*/fjnfnTt*t*^o^tt- A—96 Cbt1Amr\i^ M^mrinl 1983
-------
Appendix
CRT Regulation
-3-
A new charge is therefore added to the document
Charges for Violations of FIFRA, as follows:
Citat.ion
PERSON FAILED TO COMPLY WITH THE PROVISIONS OF THE
FEDERAL INSECTICIDE, FUNGICIDE AND ROOENTICIDE ACT
IN THAT THE PESTICIDE UAS :
£41. Mlsbranded in that it was contained in a
package or other container or wrapping which
did not conform to the standards established
by the Administrator pursuant to Section 25(c)(3).
1.e-. was not in child-res/lstant packaging.
)(E);
2(q)d)(B)
n c-res/sant pa
), 7 U.S.C. §136J(a)(l)
7 U.S.C. §136(q) ( 1 ) (B)
8. Modifications of the Civil Penalty Assessment Schedule
A matrix to facilitate calculation
a misbrinding violation is added to the
Assessment Schedule as follows:
of a penalty for
Civil Penalty
SPECIAL PACKAGING VIOLATIONS
Section One: Misbranding
1. Pesticide product contained in a package or
other container or wrapping which did not
conform to the standards established by the
Administrator pursuant to Section 25(c}(3),
i.e., was not in child-resistant packaging.
1
E41
II
III
IV
A, Toxicity Level Danger
B. Toxicity Level Warning
C. Toxicity Level Caution
500
230
120
1^50
700
300
2750
1 540
660
4250
2380
1020
5000 |
2800 |
1200 |
It is anticipated that almost all products subject to CRP
are in Toxicity Categories I (Danger) and II (Warning).
FIFBA Coapliance/Eiixori
A-97
-------
Appendix
CRP Beeulation
-9-
Violation 2: Failure to File Anended .Registration and Certification
A. Modifications of Charges
The failure to file amended registration and certification
should be charged under Charge E40, *hich states as follows:
£40. Failed to file reports required by the Act.
|12U)(2)(N). 7 U.S.C. 136J(a)(2)(N)|
B. Modifications of the Civil Penalty Assessment Schedule
A matrix for Charge E40 was not originally Included In
the Civil Penalty Assessment Schedule. MISCELLANEOUS VIOLATIONS.
p. 27717-18, Is revised to Include a Section 7, entitled:
Failure to File Reports, as follows:
7. Failure to File Reports1
II
III
IV
A. Knowledge of Report
Filing Requirement
B. No Knowledge of Report
Filing Requirement
420
180
1050
4SO
2310
990
3570
1530
4200
1800
l. Prior to December 31, 1981, the Enforcement Criteria provide
that registrants with no knowledge of the CRP requirements
(Including the report filing requirement) will not Immediately
be assessed a penalty (See Enforcement Criterion A, p. 4).
jiJjowever, if the registrant falls to negotiate or meet a
^"Compliance Schedule, the knowledge/no knowledge criteria
In the above matrix shall apply. Additionally, after
December 31, 1981, the above criteria shall apply.
VTVDA
,1 -f __.._
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Appendix
CUP Regulation
-10-
Violation 3:
failure to Maintain Records of Toxlclty and
Package Testing data'
The violation, failure to maintain records of toxldty
and package testing data. Is covered under existing materials,
Charge E39 of the Citation Charges and Section 1: A and 6,
In MISCELLANEOUS VIOLATIONS, p. 27717 of the Schedule. The
charge and pertinent sections of the Civil Penalty Assessment
Schedul-e are reproduced here for ease of use.
A. Charge
£39.
Refused to keep any records required pursuant
to Section 8 of the Act |7 U.S.C. 136f| and any
regulations promulgated thereto (40 CFR 169.2;
12(a)(2)(B), 7 U.S.C. 136J(a } (2)(8 } |
8. Civil Penalty Assessment Schedule
1. Books and Records
I II
III
IV
A. Failure to maintain
books and records as
required under §8(a)
420
1050
2310
3570
4200
Violation 4: Failure to Submit Records Upon Request to EPA2
A. Modifications to Charges
The failure to submit records upon request to EPA 1s a
1. The registrant nay not have actual data on file If the
company did not perform the testing but, Instead, relied
verification from others such as the company which
•-produces the packaging. The registrant should have a
letter or literature verifying that the packaging has
been tested and met the CRP standards.
2. The CRP regulation at 44 FR 13023 states. "These records
shall be available, upon request, for Inspection and
copying purposes or for submission to EPA."
-------
Appendix CRT Regulation
-11-
violation under FIFRA § 12(a ) (2 } (N) , which states
'It shall be unlawful for any person -- ...
(N) who is a registrant, wholesaler, dealer,
retailer, or other distributor to fall to
file reports required by this Act."
The failure to submit records when requested should be
charged under Charge £40, which states as follows:
£40. Failed to file reports required by the Act
|12(a)(2}(,N), 7 U.S.C. 1 36J (a) (2) ( N) |
B. Modifications to the Civil Penalty Assessment Schedule
The matrix to be used with Citation Charge E40 is
set up In this guidance under Violation 2; Failure to File
Amended Registration and Certification"! (See p. 9)
Violation S: Falsification of Amended Registration, Certification
Toxlclty Testing Oata. and/or Package Testing Data
A. Modifications of Citation Charges
The falsification of amended registration, certification,
Ity testing data, and/or packa<
violation under FIFRA §12(a ) (2)(M).
toxlclty testing data, and/or package testing data 1s a
"""'"" ?WH1.1
As currently worded, Citation Charge £34, which Is the
charge currently used to cite violations of FIFRA §12(a)(2)(M)
cannot be used to cite violators who knowingly falsify CRP
material. Therefore the charge Is re-worded to Incorporate
the complete language of Section 12(a)(2)(M), as follows:
£34. Knowingly falsified all or part of the
application for registration, an application
for experimental use permit, any Information
submitted to the Administrator pursuant to
Section 7, any records required to bt maln-
tained pursuant to Section 8, any report
filed under this act, or any Information
marked as confidential and submitted to the
Administrator under any provision of this Act.
l. Criminal sanctions may be sought under FIFRA §14(b)
for knowing violations of this requirement.
FIFRA Coopliance/Enforceaent A-100 O—r« -*«• v-mmal 198~
-------
Appendix
CEP Regulation
-12-
B. Modifications of the Civil Penalty Assessment Schedule
Section 5: falsified All or Part of an Application,
under MISCELLANEOUS VIOLATIONS, p. 27718 In the Schedule,
Is revised to Include a fifth gravity factor entitled E:
Any Report Filed Under This Act. The fines along the
horizontal axis are identical to the fines for the other
violations of Section 5. The matrix 1s revised as follows:
5. Falsified All or Part of «n Application
II
III
IV
A. Registration
Appl Icatl on
B. Experimental Use
Permit Application
C. Confidentiality status
D. . Submitted False
Production Data
E. Any Report Filed
Under This Act
500
500
500
500
500
1250
1250
1250
1250
1250
2750
2750
2750
2750
2750
4250
4250
4250
4250
4250
5000
5000
5000
5000
5000
FXFRA CoMDliance/Enforcement
A—im
-------
Appendix CRP Regulation
APPENDIX I
NOTICE OF WARMING - CHILD-RESISTANT PACKAGING VIOLATION
COMPANY
STREET
CITY, STATE, ZIP
Dear
This letter Is a Notice of Warning Issued pursuant to
§9(c)(3) of the Federal Insecticide. Fungicide, and Rodent1c1de
Act . as amended. (FIFRA) Informing you that an Inspection at
your facl 1 l.ty :
(Address)
(Establishment Registration t]
has shown viol atlon(s) of the chl 1d~res1 stant packaging
regulation Issued pursuant to §25(c)(3) of the FIFRA.
The EPA pronulgated a final rule (44 Federal Register 13019
March 9, 1979; 40 CFR 162.16) requiring all pesticide products
meeting certain criteria to be contained 1n child-resistant
packaging. The regulation requires child-resistant packaging
for any pesticide product released for shipment after March 9,
1981, 1f (1) Its labeling allows for residential use, (2) It
has not been classified for restricted use, and (3) It meets
certain toxlclty criteria.
An EPA Inspection showed that your product(s):
(Product Name)
(Registration f)
did not comply with the above requirements of the FIFRA,
1n that:
(Cite alleged Violations)
Our enforcement personnel have determined that the
following mitigating circumstances exist:
. We find that these circumstances Justify a conditional
exercise of prosecutorlal discretion. To avoid civil
enforcement action by the Agency, you must send this office
a Compliance Schedule within 20 days of the date of this
Notice of Warning, listing the name(s) and address(es)
of any companies with which you will deal for packaging
and/or testing of the vlolatlve products.
VI VIIA
-------
Appendix
CBF Regulation
-2-
The Conpliance Schedule nust also shon a tisietaole setting
dates for achieving toxlclty testing, packaging testing, an^
full compliance with the chlH-reslstant packaging regulation.
You must achieve full compliance within six (6) months of the
date of this letter, or no later than Oeceraber 31. 1931. which-
ever comes first.
This office will
Schedule is received.
approve or disapprove
of this- letter. This
Information required.
Information will result 1n
Schedule within 45 days.
notify you as soon as your Compliance
Regional enforcement personnel shall
the Compliance Schedule within 45 days
office will notify you of any further
Failure to furnish such requested
failure to negotiate a Compliance
If you do not submit • Compliance Schedule wlthlr
20 days of the date of the Notice of Warning, or If a
Compliance Schedule acceptable to this office Is not negotiated
within 45 days of the Notice of Warning, this office shall
assess a civil penalty, and Issue a Stop Sale. Use or Removal
Order affecting all current and future products cited In this
notice which are released for shipment. Should you. have any
questions In regard to this Compliance Schedule, please contact
at
Sincerely,
Name
Title
Regional
Office
11 B*ioa /Vn •£*»•»—-——••
FTFRA
-------
Appendix CRT Regulation
-15-
APPEHOIX 2: HYPOTHETICAL CASES
Hypothetical Case 1:
XY2 Pesticide Company manufactures and distributes a
pesticide containing 65s Calcium hypochlorlte for use as
a swimming pool disinfectant. In the course of a routine
Inspection, .the State pesticides Inspector notes that the
product Is not 1n child-resistant packaging. The Inspector
believes that this particular product should be In CRP
because the product Is listed In EPA's Phase I list of
generic products for which an unqualified assumption can
be made that they require CRP If used for residential use.
,•
In discussions with the plant manager, the Inspector 1s
Info rued that XYZ had contracted with a company to design
and test a package for their product but that the company
had gone out of business. XYZ Immediately contracted with
another company prior to March 9, 1981 but the delay caused
them to be In noncompllance as of the March 9, 1981 effective
date.
The state pesticides office refers the case to Region Z
personnel, because the state law does not Include a require-
ment for child-resistant packaging. Region Z enforcement
personnel determine that XYZ made a good faith effort.
Therefore Region Z Issues a Notice of Warning, requiring
XYZ to submit a Compliance Schedule.
XYZ submits a Compliance Schedule showing full compliance
Is to be achieved by December 1, 1981. Region Z enforcement
personnel approve the Compliance Schedule, forwarding a copy
of the approved Schedule to Headquarters. A second Inspection
In December 1981 shows XYZ to be In compliance. No further
enforcement action Is required.
-------
Appendix CBP Regulation
-16-
Hypothetical Case 2.
. The John L!oe Pesticide Conpany (JOP Co.) manuf act'jres and
distributes two pesticide products subject to the CR? regulation.
However, during a Jar.uary 1932 inspection, a State pesticides
inspector finds that neither product is in CR?,
The plant manager says that the JDP Co. negotiated and
signed a contract to obtain child-resistant packaging on
December 31, 1981 .
The State pesticides office refers the Inspection results
to the Regional office. Regional enforcement personnel,
following the enforcement criterion In effect after December 31,
198I/Issue a civil complaint (containing charges for each
pesticide) and two stop sale, use or removal .orders (for
each type of pesticide) affecting all current and future
products released for shipment. PTSED concurs with these
enforcement actions. The charges and penalties are assessed
as follows: (Note: The size of the JDP Co. was determined
to be Category I.)
Product 1 Product 2
M1sbrand1ng 500 280
(Toxlcity Level: Danger) (Toxlcity Level: Warning)
Failure to File
Amended Registration 420 420
and Certification
Failure to Maintain
Records of Toxlcity 420 420
and Package Testing
1,340 1,120
TOTAL: S 2.460
Summary of Action Taken: Civil Complaint citing charges
E41 (p.8). £40 (p.9), and E39 (p.10)
Stop Sale, Use or Removal Order
Civil Penalty of $2,460 (p.8, p.9,
and p.10)
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Appendix CEP Regulation
-17-
Hypothetical Case 3.
Several cases or" children being poisored by a pesticide
product 1n alleged child-resistant packaging corns to the
SPVs attention, .'lone of the Incidents are fatal.
EPA Headquarters alerts the Regions where the pesticide is
nanufactured. Regional enforcement personnel request the
State pesticides office 1n the state of nanufacture to conduct
an Inspection.
State pesticides Inspectors examine the files kept by the
pesticide .company. The Inspectors contact the company cited
In the pesticides company file as having performed package
effectiveness testing for the pesticide company. The Inspectors
find that the package testing company denl.es having done the
testing. The pesticide company claims that an employee, who
was fired for other transgressions, was responsible for the
falsification.
After these results are referred to the Regional Office,
Regional Enforcement personnel determine that the charge,
falsification of an amended registration, certification (£34),
toxicity testing data, and/or package testing data shall ce
cited. The company discontinues production and recalls all
products released for shipment.
A civil penalty of $2,750 1s assessed (the company 1s
size III) and a Compliance Schedule Is negotiated. A criminal
sanction 1s not-taken because: 1) there were no fatalities;
2) the company claims the data was falsified by a terminated
employee; and 3) the company cooperated to the fullest extent.
The company aeets Its Compliance Schedule, so no further
enforcement action Is taken.
Summary of Action Taken: Civil Complaint citing charge £34
(See p. 11)
Civil Penalty of $2,750 (See p. 12)
FIFRA CoaDUance/Eofar
-------
Appendix - Interln Guidelines (22 Apr 1975)
• UNITED STATES ENVIf 1ENTAL PROTECTION AGENCY
• • WASHINGTON. D.C. 20460
22APR197S
To: Enforcement Division Directors
Hazardous Materials Control Branch Chiefs
From: A. E. Conroy n
Director* Pesticides Enforcement Division
Subject: Interim Deviation from Civil Penalty Assessment Schedule
A review of the Civil Penalty Assessment Schedule as published
July 31. 1974 (39 F.R. 27656) has resulted in a determination that the
proposed penalty amounts assigned for a violation involving failure to
submit required reports of production or distribution data required
under Section 7(c) of amended FIFRA (Miscellaneous Violations.
Part 2. 39 F.R. at 27717) are excessive when considered within the
context of the gravity of harm and misconduct reasonably to be
associated with the violation. Thus for immediate use until the
Assessment Schedule is revised and republlshed. the penalty for a
violation of the Section 7 reporting requirement for the five size-
of-business categories is revised as follows:
1 n m IV V
320 BOO 1760 2720 3200
This revised penalty may be adopted to apply to any cases currently
la progress in so far as deemed practicable and fair.
In accordance with the procedures as set out in Section 3 of the
Case Proceedings Manual, "Establishment Registration Enforcement
Policy", at 4. following the expiration of twenty (20) days after the
failure to file an initial report or for failure to file by February 1 a
first annual report, or following failure to file by February 1 any
FTFRA
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Appendix Interla Guidelines (22 Apr 1975)
-2-
annual reports subsequent to the first annual report, a civil complaint
may be Issued. This policy is modified by the Memorandum of the
Director of April 10. 1975, entitled "Late Submission of Pesticides
Reports", which provides that an application for an extension of time
in the event of unforeseen circumstances filed on or before the due
date will relax the deadline for filing the report the 30 additional
calendar days. In the event the region determines to respond with a
civil complaint (as opposed to some other enforcement option) to the
failure to file after the tolling of any of the above-enumerated dead-
lines, the complaint should propose to assess the full amount of the
appropriate penalty by size-of-business in accordance with the revised
schedule specified herein. Should the report be filed within the pendency
of a civil proceeding, the proposed penalty may be mitigated as much as
forty per cent if the region feels such action is warranted based on the
facts of the case.
This policy represents an effort to establish a penalty which recog-
nizes at once the lesser value of a Section 7 related offense when compared
to other violations which have inherently more direct environmental harm,
and the need for reasonable assurance of future compliance with Section 7
requirements. Since a warning and time-extension provision is a con-
dition precedent to the application of sanctions for Section 7 violations
and since an additional 30-day extension is available to a producer for
good cause, it should never be argued that penalties for Section 7 viola-
tions are excessive because of lack of notice or experience by producers
In the requirements of this section. Further, the more experience a
producer has demonstrated with Section 7 requirements, the less avail-
able any mitigation should be in cases of violation.
Attachment
FIFRA Compliance/EnforcementA-TO* c«-f,4»«~~ M_
-------
Appendix Interim Guidelines (11 Jon 1981)
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
- '- WASHINGTON. O.C. 2C4«0
d — ".'
MEMORANDUM .
SUBJECT: FIFRA Enforcement Policy . Interim Penalty Guidelines
TO: Regional Enforceaent Division Directors
Pesticide Branch Chiefs
The Pesticides and Toxic Substances Enforceaent Division
1s 1n the process of updating the current penalty guidelines
under the Federal Insecticide. Fungicide, and Rodentldde Act
(FIFRA). Before final revisions can be completed, however,
there Is a need to develop Interim guidelines governing the
use of renedles and the response to violations which were not
1n existence at the time the current guidelines were published.
The Interim Guidelines, attached to this memorandum,
address three areas which are net covered 1n the present
guidance and under which cases are currently arising:
V.*?. °f EPA's authority to /evoke or suspend federally
' ' » i ^ '
2) The penalties which should be assessed against persons
who fall to maintain records concerning their use of restricted
use pesticides (RUPs); and
-3} The penalties which should bV assessed against persons
who use. or «ake, available for use, any RUPs other than In
accordance with section 3(d) of FIFRA.
The Interim.'' Guidelines do not represent a major departure
from the current system of determining appropriate penalties.
The Guidelines build upon existing standards for determining
dollar amounts of civil penalties to be assessed against
FIFRA
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Appendix
Inter!* Guidelines (11 Jun 1981)
-2-
vlolators of RUP-related requirements. In addition, the
criteria for deciding whether to revoke or suspend a certificate
affect only those cases arising 1n States with federally
operated certification programs.
•A. E. Conroy
Pesticides and
Enforcement
Director
rc Substances
1s1on
Attachment
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Appendix Interim Guidelines (11 Jon 1981)
MFRA ENFORCEMENT POLICY
INTERIM PENALTY GUIDELINES
Sections Affected:
FIFRA §§4 and 14
40 CFR Part 171.11
Issues:
1) When, and for how long, should Federal applicator
certifications be suspended or revoked?
2) What Is the appropriate penalty to assess against
certified commercial applicators who fall to Maintain
records concerning their use of restricted use
pesticides (RUPs)?
3) What Is the appropriate.penalty to assess against
• persons who use. or sake available for use, any RUP
other than 1n accordance with Section 3(d) of FIFRA?
Policy and Discussion
.1) Suspending or Revoking Certifications
(a) Generally.
FIFRA certification regulations (40 CFR Part 171.11) authorize
EPA to suspend, revoke, or modify-federally Issued applicator
_£ecTTnZitlojis—££.tJia.. c*r-£4^4-c«te--hol4er vfo+e-tes-fWIA or—re-girl a-
tlons promulgated thereunder.
The Office of Enforcement views an. enforcement action .
affecting certification as a strong measure, to be taken when the
•public health. Interest or welfare warrants Immediate action*
(40 CFR Part 171.11(f)(5)(1)). Therefore, this policy statement
directs that actions to revoke or suspend certifications only be
tajcjin 1n response to serious violations or against persons with
a history of noncompllance.
(b) Revocation.
The revocation of a certification not only deprives an
-------
Appendix Interim Guidelines (11 Jua 1981)
-2- _
applicator of the authority to, apply restricted use pesticides
for an Indefinite period, but also, as opposed to suspension
actions, forces the applicator to take additional steps to reacqulre
the certificate. Thus Regional personnel should only revoke a
certification where the violation has resulted In a fatality or
created an Imminent danger of a fatality, where the violator's
certification has previously been suspended, or where a person ha*s
aade fraudulent records or reports, (40 CFR Part 171.ll(f)(1)(1v)).
The term of a revocation should be not less than six Booths.
(c) Suspension.
A Region considering Invoking the less severe suspension
alternative must .determine whether It 1s appropriate to pursue
a suspension action and for how long such suspension should
be 1n effect. The answers to these questions will depend upon
the gravity of the violation.
The appendix, to this po-Mcy statement contains criteria for
-a*sej> I mr-TTre OTIV 1 tv BT a u*eL£T5rTET5ir.3" The nr«v-lty-o* a-uve
violation 1s a function of (1) the risk of harm posed to human
health and the environment by the violation. (2) and the degree
of misconduct exhibited by the violator. (See Section 7C l.b.(2)(a)
of the FIFRA Case Proceedings Manual for background information on
analyzing gravity.) The Region should assign weightings, based on
thj^gravlty criteria 1n the appendix, for each use violation
relative to the pesticide Involved, the harm to human health
and/or the harm to the environment, the history of noncompllance,
1. For purposes of this policy, a use violation means any of the
acts described In 40 CFR Part 171.11(f)(1)(1), (11), and (v).
-------
Appendix Interla Guidelines (11 Jun 1981)
-3-
and trie culpability of the violator. The total gravity value vihus
obtained Mill be used to decide whether and for how long to
to suspend a certification, In.accordance with the following
table:2
Total Gravity Value . Enforcement Remedy
4 or below No action or Warning Citation
5-8 Suspension of up to 2 months
9-12 Suspension of between 2 and 4 months
1-3 or above • Suspension «f between ~4 and 6 months
To determine whether the term of a suspension should be at
the higher tnd or at the lower end of the given ranges, the Regions
should consider any gravity-related factors not accounted for 1n
the appended gravity criteria. In addition, the Regions should
consider the degree to which the suspension will have an adverse
economic Impact on the applicator. Applicators who will be minimally
af feeted__by a_ su>>rgnTl3nr«rr?!TffA'
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Appendix Interim Guidelines (11 Jon 1981)
-4-
*
foregoing a suspension action against the applicator in favor
of issuing a warning letter or assessing a monetary or criminal
penalty, or from assessing a monetary penalty .against the firm
employing the applicator in addition to suspending the certifica-
tion of the applicator himself.
It 1s possible for commercial applicators to violate RUP
recordkeeplng requirements In addition to use restrictions. (See
40 CFR Part 171 .11 (c) {7); 40 CFR Part 171.11(f)(1) (111).)
These violations do not lend themselves to analysis utilizing
gravity of harm criteria. Consequently, OE's Interim policy
Is to base decisions to suspend the certifications of persons
who fall to maintain RUP records solely on gravity of conduct
considerations. Up to two month certification suspensions
may be assessed for the second Independent violation resulting
from the failure to maintain RUP records. For each additional
violation, two months may b« added to the term of the suspension
up to a Unit of six months. As noted In Part l(bj above, In
cases where the violation resulted from the keeping of fraudulent
records, I.e., where the violator Intentionally concealed or
misrepresented the true circumstances and extent of RUP use,
the violator's certification nay be revoked In response to the
Initial Infraction.
If EPA decides to suspend a certification, the applicator
•u»ivbe notified of the time period during which the suspension
will be effective. In order for the suspension to function as
a deterrent, the suspension should take effect during the time
ttnpJjLance/Enforcement A-11A Guidance *?«n*i 1983
-------
Appendix Interla Guidelines (II Jon 1981)
• 5-
when the applicator is most 11k .y to be applying restricted
use pesticides.3
2) Failing to Maintain RUP Records
The Office of Enforcement has not yet developed a final civil
penalty policy governing the failure to keep RUP records as
required In 40 CFR Part 171.11(c)(7), (a violation of Part
171 .11 (f) (1 )(H.i)). As interim guidance. Regional personnel
should ut 1J J.z« t*)« matrix for Sett ion 8( a) recordk<«p1nq y 1 o Vat ions
found in the current penalty guidelines (Charge Code £39). This
matrix is as follows:4
Size of Business Category
I II III IV V
Penalty Amount 450 1050 2310 3570 4200
Restricted use pesticide recordkeeping violations may
result from tne failure to maintain some or all of the infor-
mation required by Part 171.11 (c) ( 7). . Warning Ci t-ations
.Should -*« ivsiwl ifl''T«spw*« tfl f Vrst-time " parti al " record-
keeping offenses. Failure to maintain any of the required RUP
records, and "partial" recordkeeping violations following a
warning, should result In assessment of a civil penalty. Continued
violations may be addressed by a suspension action In accordance
wi thJje pol Icy iet .forth
3. EPA nay take actions affecting certification other than revo-
cations and total suspensions. Enforcement policy on the use
of such actions (i.e.. modifications, partial suspensions, and
denials of certificates), will be contained in later quldance.
4. Only one matrix Is needed since this violation, by definition.
implicates only commercial applicators.
FIFKA Compliance/Enforcement A-115
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Appendix Interim Guidelines (11 Jun 1981)
-6-
The Agency views the making of fraudulent records, as defined
above, to be a more serious violation than the failure to maintain
RUP Information. Therefore, when assessing a monetary penalty for
a violation of Part 1 71 .1 1 ( f ) (1 ) (1v ) . the Regions should utilize
the following matrix:
Size of Business Category
I II III IV V
Penalty Amount 1250 1850 3110 4370 5000
3) Using RUPs. Or Halting RUPs Available For Use. Other Than
In Accordance With Section 3(d) of FIFRA
Section 12(a)(2)(F) of FIFRA provides that *1t shall be
unlawful for any person to mike available for use, or to use,
any registered pesticide classified for restricted use for some
or all purposes other than 1n accordance with Section 3(d)."
Section 3(d) prohibits the use of RUPs by non-certified applicators.
In addition, with certain exceptions, 5 persons who make RUPs
jjy a jJ.«JB l.s TO/- m.CLEyiHfl.n-cert'i.T'i ea jip.pu.cat.ors are suDj.ec.t t_o-
penaltles under Section 12.
As Interim policy, we will make use of the existing matrix
governing another type of use violation, I.e., use Inconsistent
with labelling (Section 12 (a) (2 ) (6) ) . The Section 12(a)(2)(G)
matrix (charge code £28) In the current penalty guidelines 1s
divided Into three levels, depending on the adverse effects
-*fr.
likely to result from the violation. Since Section 12(a)(2)(F)
5. See the Proviso In Section 12(a)(2)(F) and the preamble to
to the RUP classification regulations, Part IX. 43 FR 5783,
February 9. 1978. To date, no States have Issued regulations
which would enable persons to sell RUPs under this Provlso.
Compliance/Enforcement A-116 Guidance Manual 1983.
-------
Appendix Interim Guidelines (11 Jun 1981)
-7- .
RUP violations necessarily Involve pesticides which may cause
"unreasonable adverse effects on the environment" (Section
3(d)(1)(8) ,(C)). we will utilize the uppermost level of the
«atr1x.-which ?r««ds as follows:6
S1zt of Business Category
I II III IV V
Penalty Amount 500 1250 2750 4250 5000
Thus In determining whether to assess a penalty for Section
12(a)(2j(F) violations, and .the, Mount .of such penalty., the
fl«9t«ns 'Streuld consult vxtsttng guidelines governing Section
12(a)(2)(G) violations.
6. As is the case with RUP recordkeeplng violations, only one
•atrlx Is neerfed since this type of violation Involves only
commercial app-1 Icators.
A. E. Conroy II, Director
Pesticides and Toxic Substances
Enforcement Division
-------
Appendix
Interim Guidelines (11 Jun 1981)
APPENDIX
Criteria For Determining The Gravity Of A Use
Violation For Purposes Of A Certification Action
I. GRAVITY OF HARM
A. Pesticide
B. Harm to Human
Health
C. Environmental
Harm
Weighting Activity
Z Toxldty category I pesticides,
restricted use pesticides, or
pesticides that have been demon-
strated to be associated with
chronic health effects (muta- *
genlclty, oncogenld ty, terato-
genlclty. etc.)
1 Toxldty categories II-IV, no
known chronic effects
5 Serious or widespread actual harm
to human health
3 Serious or widespread potential
harm to human health
1 Minor potential or actual harm to
human health, neither serious nor
widespread
5 Substantial or widespread actual
harm to the "errvtronraerrt,~ 1.e.,
"crops .water'. I'ive'stock , wlldl 1 fie,
wilderness, or other sensitive
natural areas
3 Substantial or widespread
potential harm to the environment
II. GRAVITY OF CONDUCT
X**
A. Moncoapllance
History
Minor harm to the environment,
neither widespread nor substantial
More than one prior violation
of FIFRA by the applicator
One prior violation
No prior violations
JRTVRA
l •'<»"'•<
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Appendix ' Interim Guidelines (11 Jun 1981)
A-2
B. Culpability - 4 Knowlnc or willful violation
I Violation resulted from negli-
gence
0 Violation was not knowing or
willful and did not result
fro» negligence; good faith
efforts made to comply with
the law
uuuumce BUUULI. J.TOJ
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Appendix Interim ftrt^UgffB (n jun 1981)
a.—izu
-------
Appendix
7 Additional Sources of Compliance/
Enforcement Information
The following is a listing of all FIFRA compliance/enforcement related
policies and guidances (other than those contained in this manual) that are
currently in effect. Copies of these documents may be obtained from
Headquarters PTSCMS or the Office of .legal and^Enforcement Policy.
TITLE OF DOCUMENT
DATE OF DOCUMENT
Enforcement Actions
"Routine Use of SEC ' 10-K1 Statements in
TSCA and FIFRA Civil Penalty Actions"
FIFRA Case Digest (Draft)
10/17/80
1983 (Draft)
ifcmitoring
Pesticides Inspection Manual
"Enforcement Policy Applicable to Bulk
Shipments of Pesticides"
"Request Procedures for Pesticide Samples
P/>1 1 rnann ion poot-^ pjrjp
"Appropriate Documents to be Presented by
State Inspectors Conducting Pesticide Use
Inspections in States Having Primacy"
1975 Edition
7/11/77
7/30/80
12/18/80
Statements (PEPS) [40 FR 19526]
"Water Purifiers"
Technical Guidance
Policy
3/5/75
8/30/75
FIFRA
:ori
A-121
Goidi
1983
-------
Appendix
SOUTCCS Of
I Mill <'
it Information
"Guidance for Enforcement Actions Involving
Water Purifier Products"
PEPS #3: Certain Enforcement Policies to be
Followed During the Phased Implementation of
FIFRA Section 3 [41 FR 13984]
PEPS 14: Preventive Pest Control Treatments
In the Absence of Target Pests [41 FR 28005]
Pest Control Devices and Device Producers
[41 FR 51065]
"Enforcement Priorities in Structural Pest Control
a) Establishment Inspections of Pest
Control Firms
b) Pesticides Use Inspections
c) Prosecutorial Discretion in Pesticide Use
Enforcement"
"Federal Pesticide Act of 1978"
"Primary Use Enforcement Responsibility"
"Review of State Certification Plans
Pursuant to FIFRA Section 26"
Notice of Rescission of Pesticide
Enforcement Policy Statements (PEPS)
Nos. 1,2,5,6,7 [44 FR 33151]
Enforcement Policy Regarding Failures
to Report Information Under
$6(a)(2) of FIFRA [44 FR 40716]
Agency Interpretation of Requirement
Imposed on Registrants by S6(a)(2) of
FIFRA [43 FR 37611]
Suspended and Cancelled Pesticides (Booklet)
Pesticide Use and Production by Veterinarians;
Statement of Policy on the Applicability of
the Federal Insecticide, Fungicide, and
Rodenticide Act to Veterinarians [44 FR 62940]
"Enforcement Actions Concerning Nonhazardous
Pesticides Devices"
"Federal Facilities Compliance"
3/15/76
4/1/76
7/8/76
11/19/76
1/24/77
8/22/78
1/4/79
3/14/79
6/8/79
7/12/79
8/23/78
10/79 (2nd
Revision)
11/1/79
12/19/79
1/16/80
Coapli ance/Baiori
A-122
Gnldance »*•"«*' 1983
-------
Appendix
Additional Sources' of
it Information
"Clarification of Primary Use Enforcement
Responsibility Guidance"
Statement of Policy on the Labeling Requirements for
Exported Pesticides, Devices, and Pesticide Active
Ingredients and the Procedures for Exporting Unregistered
Pesticides [45 FR 50274]
"Enforcement Facts and Strategy; Compliance
Monitoring Procedures; Vater Purification Devices"
"Regulation of Public Health Related Disinfectant
Products"
Pesticide Registration, Reregistration, and
Classification Procedure; Clarification of
Policy Issues on Special Packaging [46 FR. 15104]
Degy for
Enforcement of tiie Child— Resistant
Packaging Regulation under FIFRA"
Federal Insecticide, Fungicide, and Rodenticide Act,
State Primary Enforcement Responsibilities [48 FR 404]
"General Compliance Strategy for Products Subject
to the FIFRA Label Improvement Program"
3/4/80
7/28/80
10/80
12/17/80
3/3/81
6/8/81
1/5/83
4/21/83
Operating Guidance
'Final FY84 Cooperative Agreement .Program Guidance'
4/21/83
Cancellation-Suspension Enforcement Strategies
Aldrin Dieldrin
"Continuing State Registration of Products
Containing Aldrin and Dieldrin for Which
Uses Have Been Suspended"
' Uhlordane^Heptacnlor
"Enforcement of Administrator's Decision and Order
Suspending Most Uses of Heptachlor and Chlordane"
"Clarification of Heptachlor/Chlordane Suspension Order*
S
r/Chlnrdam
"Heptachlor/Chlordane Suspension Order Enforcement
Strategy"
1/10/75
1/15/76
1/22/76
2/19/76
3/23/76
umpJoance/
Gnldancfi
1983
-------
Appendix
Additional Sources of Compliance/Enforcement Information
"Heptachlor/Chlordane Suspension Order
Enforcement Strategy—CORN USE"
"Continued Enforcement of Suspension of
Registration for Certain Products Containing
Heptachlor and Chlordane"
Mercury
"Conclusion of Mercury Cancellation Proceeding"
"Enforcement of Mercury Settlement"
2,4,5-T and Si1vex
"Enforcement of Administrator's Emergency
Orders Suspending 2,4,5-T and Silvex
Regis trations"
"Further Guidance Concerning Enforcement of the
Administrator's Emergency Orders Suspending 2,4,5-T
and Silvez Registrations"
"Further Guidance on the Cancellation and Suspension
of 2,4,5-T and Silvex"
Other
"DBCP Suspension Order Enforcement Strategy"
"General Compliance Strategy for Products
Suspended Under S3(c)(2)(B) of FIFRA"
"Toxaphene Cancellation Compliance"
8/27/76
11/23/76
10/28/76
1/6/77
3/7/79
4/5/79
8/20/79
11/7/79
7/2/82
1/1/83
Compendiums
FIFRA Compliance Program Policy Compendium
Compendium Index:
Title :*r
Use Recommendations
Labeling of Outer Containers
Shipment Prior to Registration
Distributor Registrations
Fumigation of Truck Vans on Flatbed Rail Cars
Custom Blenders
Production of Pesticides for Personal Use
Contract Manufacturing
5/10/82
A.-124
1555
-------
Appendix
Additional Sources of Coapllance/Enforceaent Infomation
Release of Pesticide Production Data
Using Registered or Experimental Use Permit
Pesticides in a Manner Not Included on the Label or Permit
Closed Application Systems
Authority for Use Inspections
Pesticide Processing in Foreign-Trade Zones
Waiver of Notice of Arrival Requirements
Special Local Needs Labeling
Transfer of Use Enforcement Primacy to the States
Referral of State Misuse Cases to EPA
General Enforcement Policy Compendium
Compendium Index:
Title
3/3/83
Visitor 'ft
Hold Harmless Agreements
a Condition to Entry to EPA Employees on
Industrial Facilities"
"Professional Obligations of Government Attorneys"
"Memorandum of Understanding Between the Department
of Justice and the Environmental Protection Agency"
" *Ex Parte * Rules Covering Communications Which are
the Subject of Formal Adjudicatory Hearings"
" Quant ico Guidelines for Enforcement Litigation"
Agency -fluidelines for Fartldpetl
-------
Appendix Additional Sources of CoaT>T*ff"ce/Knfori i •• nt Ia£f>tgatlou
"Regional Counsel Reporting Relationship" 8/3/83
Additional Sources of FIFRA Compliance Enforcement Information
EPA Delegations of Authority
EPA Manual of Pesticide Misuse Review Committee Policy,
Procedures, Cases, and Advisory Opinions
EPA Security Manual
Notices of Judgment
Office of Pesticide Programs Policy and Criteria! Notice Manual
SFIREG Charter
FIFRA Goapliance/Enforcttent A-126 Gnld
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