Federal Insecticide, Fungicide,
and Rodenticide Act
COMPLIANCE/ENFORCEMENT
GUIDANCE MANUAL
U.S. ENVIRONMENTAL PROTECTION AGENCY
Washington DC 20460
Prepared by
Pesticides and Toxic Substances Compliance Monitoring Staff
and
Office of Legal and Enforcement Policy
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Table of Contents
Chapter One; Overview
Purpose of the Manual
Overview of the Act
The Federal Insecticide, Fungicide and Rodenticide Act (As Amended)
FIFRA Regulatory Elements
Registration of Pesticides
Establishment Registration
Pesticide Disposal
Experimental Use Permits
Emergency Exemptions for Federal and State Agencies
State Registration of Pesticides
Glossary
Chapter Two; General Operating Procedures
Primary Office Responsibilities
Concurrence Procedures
State and Federal Interagency Cooperation
Organizational Charts
Chapter Three; Compliance Monitoring Procedures
Introduction
Inspections
Records and Establishment Inspections
Use/Misuse Investigations
Warrants
Subpoenas
Chapter Four; Documentation of Evidence
Introduction
Inspection File Review
Review of Adequacy of Evidence
FIFBA ^^"•pl * MTtf^/itnfnfffmfmt- Guidance **"«">« 1983
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Chapter Five; Determination of Appropriate Enforcement Response
Introduction 3 a ••,&#'•
Level of Action Policy • '-•-:. ?rr: jS
i.'-.
Chapter Six; Administrative Enforcement Actions; Notices of Violation and
Administrative Orders
Introduction
Administrative Enforcement Procedures
Chapter Seven; Administration Enforcement Actions; Civil Penalty
Proceedings
Introduction
Elements of a Violation: Administrative
Complaint Preparation and Filing
Pre-Hearing Stage
Hearing Stage
Post-Hearing .Stage
Chapter Eight; Judicial Enforcement; Civil Actions
Introduction
Elements of a Violation: Civil
Procedures for Filing Actions
Injunctive Actions
In Bern (Seizure) Actions
Settlement Agreements
Chapter NlTte^ Judicial Enforcement; Criminal Actions
Statutory Authority
Basic Enforcement Policy
Criteria for Identification of a Potential Criminal Action
Procedures for the Investigation and Referral of a Criminal Case
Chapter Ten; Post-Settlement Enforcement
Monitoring Settlement Agreements
Enforcement of Settlement Agreements
Chapter Eleven; Special Considerations
TXZ1A .Section 7 Confidential Information
Disclosure of Confidential Information
FIFKA Compliance/Enforcement Guidance Manual 1983
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Appendices
Neutral Administrative Inspection Scheme
Notices of Judgment
Sample Record Status and Permanent Abeyance Procedures
Collection of Civil Penalty Assessments
Expert Witnesses
Penalty Policies
Additional Sources of Compliance/Enforcement Information
FTFRA Covpllaiice/Enforceaent Guidance n*™*! 1983
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Chapter One
Overview
Chapter Contents Page
1 Purpose of the Manual 1-1
Reservation 1-1
The Update System 1-1
Common Acronyms and Abbreviations Used in this Manual 1-2
2 Overview of the Act 1-3
Purpose and Scope 1-3
Authorities and Responsibilities 1-4
Synopsis of the Act 1-4
3 The Federal Insecticide, Fungicide, and Rodentlcide Act 1-13
(As Amended)
4 FIFRA Regulatory Elements 1-47
4a Registration of Pesticides 1-49
Applicability of Registration Requirements 1-49
Registration Procedures 1-51
Labeling Requirements 1-54
4b Establishment Registration 1-55
Authority 1-55
Objectives 1-56
Applicability of Registration Requirements 1-56
Registration Procedures 1-57
Establishment Registration Numbers 1-58
Establishment Production Reports 1-59
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Ac Pesticide Disposal 1-63
Authority 1-63
Enforcement Actions and Disposal Practices 1-63
4d Experimental Use Permits 1-65
Authority 1-65
Scope 1-65
Permit Application Procedures 1-65
Labeling Requirements 1-66
4e Emergency Exemptions for Federal and State Agencies 1-67
Types of Exemptions 1-67
Procedures To Be Followed 1-68
Withdrawal of Exemptions 1-70
4f State Registration of Pesticides 1-71
Conditions for Section 24(c) Registration 1-71
Types of Section 24(c) Registrations 1-71
Registration Disapproval/Suspension 1-72
5 Glossary 1-73
FIFRA CbppllOTCf/Enforcement1-11
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Chapter One
1 Purpose of the Manual
The purpose of this manual is to provide guidance to pesticide regulatory
personnel on the substantive and procedural requirements necessary for
ensuring compliance and preparing enforcement cases under the Federal
Insecticide, Fungicide, and Rodenticide Act, as amended (FIFRA).
The manual describes the processes of case development and Judicial pro-
ceedings including the analyzing of evidence collected during a compliance
inspection to determine its sufficiency to document a suspected violation;
issuing of an enforcement action; presenting evidence in an adjudicatory
hearing; and monitoring compliance with consent decrees.
Reservation
The policies and procedures set forth herein and the internal office proce-
dures adopted pursuant hereto are intended solely for the guidance of U.S.
Environmental Protection Agency personnel. These policies and procedures
are not intended to be relied upon to create a right or benefit (substan-
tive or procedural) enforceable at law by a party to litigation with the
United States Environmental Protection Agency. The Agency reserves the
right to take any action alleged to be at variance with these policies and
procedures or that is not in compliance with internal office procedures.
The Update System
As revised or additional material is developed for the manual, it will be
distributed to all manual holders. A transmittal form will accompany and
explain these changes. The revised or additional pages will be Identical
to the original page, but with added identification at the bottom of the
page.
Pag* CkiMoe* Haimil (T*ir)
FIFMA compliance/mxorcement 1-1 Guidance narnuii
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Chapter One
When revisions entail the addition of pages into the manual (i.e., when
three pages in the manual are replaced by five pages), the additional pages
will be numbered as follows:
Original numbering: 3-3, 3-4, 3-5, 3-6, etc.
Addition of pages: 3-3, 3-4, 3-5a, 3-5b, 3-5c, 3-6, etc.
This system will allow updates to be made quickly and easily and will avoid
disruption of the chapters. New material will be numbered sequentially by
chapter.
Common Acronyms and Abbreviations Used in this Manual
C.F.R. — Code of Federal Regulations
CROP — Consolidated Rules of Practice
EPA — United States Environmental Protection Agency
FDA — Food and Drug Administration
FIFRA — Federal Insecticide, Fungicide, and Rodentlcide Act, as amended
HQCDO — Headquarters Case Development Officer
OLEC — Office of Legal and Enforcement Counsel
PTSCMS — Pesticides and Toxic Substances Compliance Monitoring Staff
RCDO — Regional Case Development Officer
RD — Registration Division
RHP — Restricted Use Pesticide
SSDRO — Stop Sale, Use, or Removal Order
U.S.C. — United States Code
1-2 Gold
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Chapter One
2 Overview of the Act
The Federal Insecticide, Fungicide, and Rodenticide Act, Public Lav 92-516
(1972), as amended by Public Lav 94-140 (1975), Public Lav 95-396 (1978),
and Public Lav 96-539 (1980) vas passed by Congress as the primary statute
for pesticide control and regulation. The Act, referred to as "FIFBA," is
codified in Title 7 of the United States Code. Regulations promulgated
pursuant to the Act are found at 40 C.F.R. Parts 162 through 180.
Purpose and Scope
FIFRA and its amendments are designed to provide for pre-market clearance
of pesticides and post-market surveillance of pesticides and pesticidal
devices to ensure prevention of unreasonable adverse effects upon human
health or the environment. Under FIFRA, the term "pesticides" Includes:
• Substances (other'than "nev animal drugs" or animal feeds) intended
for preventing, destroying, mitigating, or repelling any "pest"
defined to include organisms ranging from viruses and bacteria to
rodents; and
• Substances intended for use as plant regulators, defoliants, or
dessicants.
The Act prohibits (subject to certain exceptions) any Individual from • ,
distributing, selling, offering or holding for sale, •hipping, delivering
for shipment, or receiving and (having so received) delivering or offering
to deliver any pesticide product not registered with the Administrator of
EPA. Registration may be refused, restricted, suspended, or cancelled $>y
the Administrator where appropriate to ensure protection of the environ-r
ment. Under the Act, all producers of pesticides and pesticidal device*
ere required to register their establishments with the Administrator«1
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Chapter One Overview of the Act
Products Not Subject to the Act
Certain products are not classified as pesticides and, therefore, are not
subject to the Act. They include:
-« Deodorizers, bleaching agents, and cleaning agents for which no
pesticidal claims are made;
• Paints and other formulated coatings that are treated with fungi-
cides to protect the coating Itself and that bear no claims for
protecting other: surfaces or objects;
• Building material products (such as lumber, fiber boards, adhe-
sives, and caulking material) that have been treated to protect the
material Itself against pests and for which no pesticidal claims
are made as to protecting other surfaces or objects;
• Fabric products that have been treated to protect the fabric itself
from insects, fungi, or other pests and .for which no pesticidal
claims are made as to protection of other surf aces or objects;
• Fertilizers and other plant nutrients; and
• Intermediate substances intended for the production of a pesticide
product by chemical reaction with other substances.
Authorities and Responsibilities _____
The Administrator of EPA Is authorized to administer the Act In a reason-
able and prudent manner, often considering the economic, social, and
environmental costs and benefits of actions taken under FIFRA. Within EPA,
several offices are responsible for providing national guidance for FIFRA
compliance enforcement activities. These offices and their responsibili-
ties are discussed in Chapter Two.
of the Act _
FIFRA authorises the registration of pesticides as veil as pesticide-
producing facilities. Specific authorities are provided for the inspection
of establishments, books, and records. The Act also provides for classifi-
cation of pesticides for general use or restricted use; certification of
jBfipJLieatoxs £ or jesrrigted «sc pesticides; Issuance of experimental use
ts; mud promulgation of pBsticide application standards . Protection
is afforded trade secrets and certain other business information deemed
confidential by the registration applicant. Provisions are made under the
Act for imposition of civil or criminal penalties.
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Chapter One Overview of the Act
Procedures for issuing a stop sale, use, or removal order (SSURO) or
seizing violative pesticides or devices are detailed. The statute also
provides authority to enter into cooperative agreements with the States.
These sections of FIFRA are briefly reviewed below.
Registration of Pesticides (Section 3)
Applications for registration must include information relating to the
labeling of the pesticide as well as the labeling Itself, a statement of
all claims made by the manufacturer, and directions for using the pesti-
cide. The Administrator is required to publish guidelines for the
submission of Information in support of the application. In general, an
application will be approved when the information submitted supports the
assertion that the pesticide will perform its claimed function(s) and indi-
cates that the pesticide will not present an unreasonable risk to the
environment when used properly. The Administrator is required to classify
all pesticides for either general or restricted use or both; may condition-
ally register pesticide products that are Identical or substantially
similar to those currently registered; and may approve new and added uses
of currently registered pesticides. The Administrator is required to
accomplish the re-registration of all pesticides in the most expeditious
manner practicable.
Use of Restricted Use Pesticides; Certified Applicators (Section 4)
EPA must establish standards for the certification of pesticide appli-
cators. For those States that do not have a State certification plan
approved by the Administrator, the Agency is to conduct its own certifica-
tion program for pesticide, applicators. Approval of a State's certi-
fication program may be withdrawn if the Administrator determines that the
State program Is not being administered in accordance with the terms of the
approval.
Experimental Use Permits (Section 5)
Any person may apply to the Administrator for an experimental use permit
for a pesticide. Approval of the experimental use permit is conditional
upon the Agency's review of the application and all required supporting
data, as well as the applicant's need for Information to support the regis-
tration. The permit may specify terms and conditions deemed appropriate by
the Administrator. Should these terms or conditions be violated, or inade-
quate to avoid an unreasonable adverse effect on the environment, the
permit may be revoked.
A^p<"istrative Review; Suspension (Section 6)
The Administrator shall cancel the registration five years from the date of
registration unless the registrant or other interested person requests the
continuance of the registration in accord with re-registration regulations
fIFRA Compliance/Enforcement 1-5
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Chapter One Overview of the Act
prescribed by the Administrator. The Administrator may cancel or change
the classification of a registered pesticide if it is determined that its
labeling or other material required to be submitted is not in compliuace
with the Act or if the pesticide causes unreasonable adverse effects to tne
environment. The Act requires that notice of the order be sent to the
registrant and be made public. A hearing to dispute the order must be
provided to any person adversely affected by the notice. The Administrator
can also cancel a registration that was Issued conditionally if the regis-
trant fails to meet any condition imposed or falls to Initiate and pursue
appropriate action toward fulfilling any condition Imposed. Section 6
further provides that If a pesticide is determined to be an imminent hazard
during the period required for cancellation or change of registration
proceeding, its use may be Immediately suspended by the Administrator upon
proper notice and availability of an expedited hearing.
Registration of Establishments (Section 7)
Any establishment producing pesticides, active ingredients used in produc-
ing pesticides, or pestlcldal devices must be registered with the
Administrator. Information submitted in this registration process, other
than the names of the pesticides or active ingredients used in producing
pesticides, will be subject to the confidentiality provisions of Section
10.
Books and Records (Section 8)
The Administrator may prescribe regulations requiring producers to maintain
records pertaining to their operation as veil as pesticide and device
records considered necessary for the enforcement of the Act. Financial
data, sales data other than shipment data,, pricing data, personnel data,
and research data other than data relating to a registered pesticide or
pending registration are exempt from this rule. Inspection and copying of
shipping records or, in the absence thereof, records relating to shipment
are permitted upon presentation of proper credentials by a duly authorized
employee of EPA or any State.
i
Inspection of Establishments (Section 9)
T&XA authorize*, upon presentation of proper rcredentiale and -notice, the
Inspection (at reasonable times) of establishments or other places where
pesticides and devices are held for distribution or sale. A written
notice, detailing the reason for the inspection and noting whether a viola-
tion of the law is suspected, must be presented prior to entry. Inspectors
•ay obtain camples of any pesticides or devices that are packaged, labeled,
and released for shipment and samples of any such containers and labeling.
If necessary, tarranf* may fee obtained from a district court to gain entry«
Jjvpeet* and reproduce certain -records relating to pesticides or devices,
or to seize any pesticide or device. For minor violations, a written
notice of warning may be issued.
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Chapter One Overview of the Act
Protection of Trade Secrets and Other Information (Section 10)
This section of FIFRA provides for the protection of trade secrets and
certain business information obtained under FIFRA. Applicants may claim
Information as confidential or dispute the release by the Administrator of
any information the manufacturer feels is confidential. United States
employees who willfully disclose trade secrets are subject to criminal
penalties.
Standards Applicable to Pesticide Applicators (Section 11)
Separate standards for licensing and certification are established for
commercial and private applicators. Private applicators are not required
to maintain any records or to file any reports.
Unlawful Acts (Section 12)
*
Section 12 establishes the acts that are unlawful under FIFRA. These
include, inter alia, registration, labeling, and use violations. See
Chapter Seven for a complete listing.
Stop Sale, Use, or Removal and Seizure (Section 13)
The Administrator may issue a stop sale, use, or removal order under the
following circumstances:
• When, based on inspection or tests, there is reason to believe that
a pesticide or device is in violation of the Act or will be sold or
distributed in violation of the Act; or
• When the registration of a pesticide has been cancelled or
suspended.
Additionally (if certain unlawful acts are being carried out), pesticides
or devices may be seized for condemnation upon action In a district court.
Penalties (Section 14)
Any registrant, commercial applicator, wholesaler, dealer, retailer, or
other distributor who violates any provision of the Act Bay be assessed a
civil penalty of up to $5,000 per offense. Should any of the above-
mentioned parties knowingly or willfully violate the Act, a criminal
penalty of up to $25,000 and/or Imprisonment for up to one year may be
imposed. A private applicator or other person not Included above who
violates the Act after receiving a warning letter or citation for a prior
violation may receive a $1,000 civil penalty for each subsequent offense.
"For hire" applicators may be fined $500 for the first offense and $1,000
FIFgA Ooapli«nce/Enf orceaent 1-7 "Guidance"
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Chapter One Overview of the Act
for each subsequent offense. Criminal penalties for private applicators
and "for hire" applicators may be a fine of up to $1,000, 30 days' Impri-
sonment, or both.
Indemnities (Section 15)
Under certain conditions EPA may make indemnity payments to persons
suffering losses due to the cancellation or suspension of a pesticide
registration.
Administrative Procedure; Judicial Reviev (Section 16)
District courts are given authority to review those Agency final actions
that are not given to agency discretion by lav. These courts are also
vested with jurisdiction to enforce, prevent, and restrain violations of
the Act. United States courts of appeals have exclusive jurisdiction to
affirm or set aside an order issued by the Administrator. All judgments
entered In actions instituted under -the Act are to be published.
Imports and Exports (Section 17)
Pesticides and pesticidal devices may not be imported for use In the United
States If they violate any provision of the Act. Pesticides or pesticidal
devices Intended solely for export nay be produced and packaged according
to purchaser specifications but will be subject to certain provisions of
Sections 2, 7, and 8 of the Act.
Exemption of Federal Agencies (Section 18)
The Administrator may exempt Federal and State agencies from any provision
of the Act under emergency conditions.
Disposal and Transportation (Section 19)
Procedures and regulations for disposal and storage of pesticides must be
established. The Adminlntrator will advise «nd c*8ist the Department of
"Traaaiportatlon In matters relating to ^he transportation of hazardous
materials. If a pesticide Is cancelled under Section 6(c), the
Administrator, at the request of the pesticide owner, Is to provide a safe
disposal site. Specific provisions for the disposal of unused quantities
of a cancelled pesticide must appear In the notice of cancellation.
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Chapter One Overview of the Act
Research and Monitoring (Section 20)
Research necessary to carry out the Act is authorized. The Administrator
will formulate and carry out a national plan to monitor pesticide exposure
and pollution.
Solicitation of Comments; Notice of Public Hearings (Section 21)
The Administrator must solicit the views of the Secretary of Agriculture
prior to publishing regulations and may solicit, from other interested
persons, views relating to any action authorized under the Act. Timely
notice of all public hearings must be published in the Federal Register.
Delegation and Cooperation (Section 22)
The Administrator may delegate to EPA employees any or all vested authority
contained in the Act. The Administrator must cooperate with other agencies
in carrying out the Act.
State Cooperation, Aid, and Training (Section 23)
The Administrator may enter into cooperative agreements with States and
Native American Indian tribes for the purposes of delegating authority to
carry out the Act and to train personnel. The Administrator also may
assist them with contracts to encourage training certified applicators.
Authority of States (Section 24)
A State may regulate the sale or use of any federally registered pesticide
or pesticidal device to meet its special needs, as long as it is in accor-
dance with the Act. The State may register new uses for registered pesti-
cides for use only in the State. The new use may not be a food or feed use
unless it is consistent with the Federal Food, Drug, and Cosmetic Act.
With just reason, the Administrator may suspend the State's authority to
register pesticides under this section.
Authority of the Administrator (Section 25)
The Administrator nay prescribe regulations to carry out the Act* Proposed
and ..final regulations must be given to the Secretary of Agriculture for
comment. All comments will be published In the Federal Register on a pres-
cribed time schedule. The House and Senate Agriculture committees must
also be notified. A scientific advisory panel will comment on the regula-
tions, using the same time schedule as the Secretary of Agriculture, and
the comments will also be published in the Federal Register.
Itrnpliance/Etafor
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Chapter One Overview of the Act
The Administrator has the authority to determine what is a pest, to specify
which devices are subject to the Act, to establish packaging standards for
pesticides and devices, to prescribe regulations requiring pesticides to be
colored, to establish suitable names for use in active ingredient state-
ments, and to determine whether pesticides are toxic to human health.
State Primary Enforcement Responsibility (Section 26)
A State has the primary enforcement responsibility for pesticide use viola-
tions (primacy) if the State laws and regulations are deemed adequate by
the Administrator, if sufficient enforcement procedures are adopted and
used, and if the State keeps records and makes reports of such compliance
as required by the Administrator.
A State may also obtain primacy by entering into cooperative agreement for
the enforcement of use violations under Section 23 or by demonstrating that
their Section 4 certification plan meets the criteria described above.
The Administrator has primary enforcement responsibility for States that do
not have primacy.
Failure by the State To Assure Enforcement of State Pesticide Use
Regulations (Section 277
The Administrator must notify the State of any significant allegations of a
pesticide use violation of the Act. If within 30 days of the referral the
State has not commenced appropriate enforcement action, EPA may bring its
own action. The Administrator is empowered to rescind primacy if it is
found that the State is not carrying out its pesticide use enforcement
responsibility. If an emergency exists and the State is unable or
unwilling ;to'^respond, ^the Administrator is authorized to
action.
Identification of Pests; Cooperation with Department of Agriculture's
Program (Section 28)
The Administrator, In coordination with the Secretary of Agriculture, Is to
identify those pests that must be controlled.. -In. addition, the
*•*•*«»*«*»•»»•*«• 4 « »« coordinate *lth the Secretary of .Agriculture *s research
and Implementation programs in order to determine the safest and most
effective pesticides or control methods available.
Annual Beport (Section 29)
An f«»T«M»i xeport must be submitted to: Congress igr the Adaliilstrstor before
16 *>f - each year » llstlTig all the applications for conditional
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registration and approvals of such applications. The findings, imposi-
tions, modifications, and quantities of each conditionally registered
pesticide that is produced must be included.
fUFHA. Compliance/Enfor
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Chapter One Overview of the Aft-
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Chapter One
3 Federal Insecticide, Fungicide, and
Rodenticide Act CAs Amended]
La* 92-Stt, Kmt Cityim, HJt. 10739, Omkm U, 1972
Law M.51. tt* Caavwa. HJL 43T7, My 2. 1973;
Lav M.IM. Mak Ciaraa. S. 2375. Qtntir 10, 1975;
Law M.I4*. M* CaaanH, HJL SS41, .Ntnartrr 2S. 19*5:
Law 95-231, 93* CoapM. HJL 6975, Mart* 27. 1978:
Uw 99.394. 95ta Caaaru*. S. K7S. ScateMtar M. 1978:
o«tm§. Dict«>y 17. 19W)
fln flct
Ktdcral
l-nvironmcnlil
Pmicidt
Control Ao
ol 197:.
61 Slic. 163:
71 Sill. 190.
86 STAT. 973-999
To amend the Federal Insecticide, Fungicide, and Rodenticide Act, and For
other purposes.
Be it enacted by the Senate and House Representatives of the United Slates
of America in Congress assembled. That this Act may be cited as the "Federal
Environmental Pesticide Control Act of 1972."
Amendments to Federal Insecticide, Fungicide, and Rodenticide Act
Sec. 2. The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136
et seq.) is amended to read as follows:
"SECTION 1. SHORT TITLE AND TABLE OF CONTENTS.
(a) Short Title — This Act may be cited as the 'Federal Insecticide,
Fungicide, and Rodenticide Act'.
(b) Table of Contents —
"Section I. Shori title and table of comems.
"(a) Short tide.
"(b) Table of contents.
"Sec. 2. Definitions.
"(a) Active ingredient.
"(b) Administrator.
"(c) Adulterated.
"(d) Animal.
"(e) Certified applicator, etc.
"(I) Certified applicator.
_ "(2) Private applicator.
"(3) Commercial applicator.
• "(4) Under the direct supervision
of a certified applicator.
"(0 Defoliant.
"(I) Desiccant.
' "(h) Device.
"(i) District court.
"(j) Environment.
"(k) Fungus.
"(I) Imminent hazard.
"(m) Inert ingredient.
"(n) Ingredient statement.
"(o) Insect.
"(p) Label and labeling.
"(I) Label.
"(2) Labeling.
P.I..
42 Sill. »J»
"(q) Misbranded.
"(r) Nematode.
"(s) Person.
"(t) Pest.
"(u) Pesticide.
"(v) Plant regulator.
"(w) Producer and produce.
"(x) Protect health and the environ-
ment.
"(y) Registrant.
"(2) Registration.
"(aa) Stale.
"(bb) Unreasonable adverse effects on
the environment.
"(cc) Weed.
"(dd) Establishment.
"(ee) To use any registered pesticide in a
manner inconsistent with its labeling.
"Sec. 3. Registration of pesticides.
"(a) Requirement.
"(b) Exemptions.
"(c) Procedure for registration.
"(I) Statement required.
"(2) Data in support .of registra-
tion.
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Chapter One
FIFRA
"(3) Time for acling with respect
to application.
"(4) Notice of application.
"(5) Approval of registration.
"(6) Denial of registration.
"(7) Registration under special cir-
cumstances.
"_(%) Interim administrative review •
"(d) Classification of pesticides.
"(I) Classification for general use,
restricted use. or both.
"(2) Change in classification.
"(3) Change in classification from
restricted use to general use.
"(e) Products with same formulation
and claims.
"(0 Miscellaneous.
"(I) Effect of change of labeling
or f01 mutation.
"(2) Registration not a defense.
"(3) Authority 10 consult other
Federal agencies.
"(g) Registration of pesticides. ,
"Sec. 4. Use of restricted use pesticides; certified
applicators.
"(a) Certification procedure.
"(I) Federal certification.
"(2) Slate certification.
"(b) State plans.
."(c) Instruction in integrated pest
' . management'techniques.
"Sec. S. .Experimental use permits.
"(a) Issuance.
"(b) Temporary tolerance level.
"(c) Use under permit.
"(d) Studies.
"(e) Revocation.
"(0 State issuance of permits.
"(g) Exemption for agricultural research
agencies.
"Sec. 6. Administrative review;suspension...
"(a) Cancellation after five years.
"(I) Procedure.
"(2) Information.
"(b) Cancellation and change in classifi-
cation.
"(c) Suspension.
"(I) Order.
"(2) Expedite hearing.
"(3) -Emergency order.
"(4) Judicial review.
Public heai ings and -scientific re-
"Sec.
Sec.
• "Sec.
"Sec.
"(b)
"Sec.
view.
"(e) Conditional registration.
"(0 Judicial review..
7. Registration of establishments.
"(a) Requirements.
"(b) Registration.
"(c) Information required.
"(d) Confidential records and informa-
tion.
, 8. Books and records.
"(a) Requirement.
**|b) Inspection.
"(a) In general.
_"(b)_ Warrants.
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Chapter One
FIFRA
"SEC. 2. DEFINITIONS.
"For purposes of this Act—
"(a) Active Ingredient.—The term 'active ingredient' means—
"(1) in the case of a pesticide other than a plant regulator, defoliant,
or desiccant, an ingredient which will prevent, destroy, repel, or
mitigate any pest;
"(2) in the case of a plant regulator, an ingredient which, through
physiological action, will accelerate or retard the rate of growth or rate
of maturation or otherwise alter the behavior of ornamental or crop
plants or the product thereof;
"(3) in the case of a defoliant, an ingredient which will cause the
leaves or foliage to drop from a plant; and
"(4) in the case of a desiccant, an ingredient which will artificially ac-
celerate the drying of plant tissue.
"(b) Administrator.—The term 'Administrator* means the Administrator
of the Environmental Protection Agency.
"(c) Adulterated.—The term 'adulterated* applies to any pesticide if:
"(I) its strength or purity falls below the professed standard of quali-
ty as expressed on its labeling under which it is sold;
"(2) any substance has been substituted wholly or in part for the
pesticide; or
"(3) any valuable constituent of the pesticide has been wholly or in
part abstracted.
"(d) Animal.—The term 'animal* means all vertebrate and invertebrate
species, including but not limited to man and other mammals, birds, fish, and
the shellfish.
"(e) Certified Applicator, Etc.—
"(I) Certified applicator.—The term 'certified applicator' means any
individual who is certified under section 4 as authorized to use or super-
vise the use of any pesticide which is classified for restricted use. Any
applicator who holds or applies registered pesticides, or use dilutions of
registered pesticides consistent with section 2
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Chapter One PIFRA
"(k) Fungus. — The term 'fungus' means any non-chlorophyll-bearing
thallophyte (thai is, any non-chlorophyll-bearing plant of a lower order than
mosses and liverworts), as for example, rust, smut, mildew, mold, yeasi, and
bacteria, except those on or in living man or other animals and those on or in
processed food, beverages, or Pharmaceuticals.
"I) Imminent Hazard.—The term 'imminent hazard* means a situation
which exists when the continued use of a pesticide during the time required for
cancellation proceeding would be likely to result in unreasonable adverse ef-
fects on the environment or will involve unreasonable hazard to the survival of
a species declared endangered by the Secretary of the Interior under Public
Law 91-133.
«.iMa..:7.v "(m) Inen Ingredient.—The term "inert ingredient' means an ingredient
IMIM MUUV.I. which is not active.
"(n) Ingredient Statement.—The term 'ingredient statement' means a state-
ment which, contains—
*'(!) the name and percentage of each active ingredient, and the total
percentage of all inert ingredients, in the pesticide; and
"(2) if the pesticide contains arsenic in any form, a statement of the
percentages of total and water soluble arsenic, calculated as elementary
arsenic.
"(o) Insect.— The term 'insect* means any of the numerous small in-.
vertebrate animals generally having the body more or less obviously
segmented, for the most part belonging to the class insecta, comprising six-
legged, usually winged forms, as for example, beetles, bugs, bees, flies, and to
other allied classes of arthropods whose members are wingless and usually
have more than six legs, as for example, spiders, mites, ticks, centipedes, and
wood lice.
"(p) Label and Labeling.—
"(I) Label.—The term 'label* means the written, printed, or graphic
matter on, or attached to, the pesticide or device or any of its containers
or wrappers.
"(2) Labeling.— The term "labeling' means all labels and all other
written, printed, or graphic matter—
"(A) accompanying the pesticide or device at any time; or
"(B) to which reference is made on the label or in literature ac-
companying the pesticide or device, except to current official
publications of the Environmental Protection Agency, the United
Slates Departments of Agriculture and Interior, the Department of
Health, Education, and Welfare, State experiment stations, State
agricultural colleges, and other similiar Federal or State institutions
or agencies authorized by law to conduct research in the field of
pesticides.
"(q) Misbranded.—
"on the label «r labeling is not
. : pronuueudy placed thereon wit*i:suco compkuousness (as compared
with other words, statements, designs, or graphic matter in the label-
ing) and in such terms as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase
and use;
"(F) the labeling accompanying it does not contain directions for
use which are necessary for effecting the purpose for which the
product is intended and if complied with, together with any re-
i us* i3«i. quirements imposed under section 3(d) of (his Act, are adequate to
protect health and the .environment;
* ••(Qtte'lRM.doesiBM caatraavnraagorc^
which ttgy-be necessary and if compiled1 with, together with any re-
T use iite. quirements imposed under section 3(d) of this Act, is adequate to
protect health and the environment; or
PL ts-jw: nsut it* "(if) in the case of a pesticide not registered in accordance with
7 use IN*. section 3 of this Act and intended for export, the label does not con-
tain, in words prominently placed thereon with such conspicuousness
FXftA
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Chapter One FIFBA
(as compared with other words, statements, designs, or graphic mat-
ter in the labeling) as to render it likely to be noted by the ordinary
individual under customary conditions of purchase and use, the
following: 'Not Registered for Use in the United States of America'.
"(2) A pesticide is misbranded if—
"(A) the label does not bear an ingredient statement on that pan
of the immediate container (and on the outside container or wrapper
of the retail package, if there be one, through which the ingredient
statement on the immediate container cannot be clearly read) which
is presented or displayed under customary conditions of purchase,
except that a pesticide is not misbranded under this subparagrapn if:
"(i) the size of form of the immediate container, or the outside
container or wrapper of the retail package, makes it impracticable
to place the ingredient statement on the part which is presented or
displayed under customary conditions of purchase: and
"(ii) the ingredient statement appears prominently on another
part of the immediate container, or outside container or wrapper,
permitted by the Administrator;
"(B) the labeling does not contain a statement of the use
classification under which the product is registered;
"(Q there is not affixed to its container, and to the outside con-
tainer or wrapper of the retail package, if there be one, through
which the required information on the immediate container cannot
be clearly read, a label bearing—
"(i) the name and address of the producer, registrant, or per-
son for whom produced;
"(ii) the name, brand, or trademark under which the pesticide
is sold;
"(iii) the net weight or measure of the content; Provided. That
the Administrator may permit reasonable variations; and
"(iv) when required by regulation of the Administrator to ef-
fectuate the purposes of this Act, the registration number as-
signed to the pesticide under this Act, and the use classification;
and
"(D) the pesticide contains any substance or substances in quan-
tities highly toxic to man, unless the label shall bear, in addition to
any other matter required by this Act—
"(i) the skull and crossboncs;
"(ii) the word 'poison* prominently in red on a background of
distinctly contrasting color; and
"(iii) a statement of a practical treatment (first aid or otherwise) j
in case of poisoning by the pesticide. !
"(r) Nematode.—The term 'nematode' means invertebrate animals of the ,
phylum nemathelminthes and class nernatoda, that is, unsegmented round
worms with elongated, fusiform, or saclike bodies covered with cuticle, and
inhabiting soil, water, plants, or plant parts; may also be called nemas or ,
eelworms.
"(s) Person.—The term 'person' means any individual, partnership,
association, corporation, or any organized group of persons whether incor-
porated or not.
"(t) Pest.—The term 'pest* means (1) any insect, rodent, nematode,
fungus, weed, or (2) any other form of terrestrial or aquatic plant or animal
life or virus, bacteria, or other micro-organism (except viruses, bacteria, or
other micro-organisms on or in living man or other living animals) which the
Administrator declares to be a pest under section 2S(cXO. ruse i»>.
"(u) Pesticide.—The term'pesticide'means (I) any substance or mixture of IM..W-MO:
substances intended for preventing, destroying, repelling, or mitigating any ** *"• 7J4
pest, and (2) any substance or mixture of substances intended for use as a plant
regulator, defoliant, or desiccant: Provided, That the term •pesticide' shall not
include any article (IXa) that is a 'new animal drug* within the meaning of sec-
tion 20l(w) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 32l(w)).
•or (b)-that has been determined by the Secretary of Health, Education, and
Welfare not to be a new animal drug by a regulation estabHshhig condhioos of
use for the article, or (2) that is an animal feed within the meaning of section
20l(x) of such Act (21 U.S.C.321(x)) bearing or containing an article covered
by clause (1) of this proviso."
'X v) Plant Regulator.—The term 'plant regulator' means any substance or
mixture of substances intended, through physiological action, for accelerating
or retarding the rate of growth or rate of maturation, or for otherwise altering
the behavior of plants or the produce thereof, but shall not include substances
. to the extent that they are intended as plant nutrients, trace demerits, nutri-
tional chemicals, plant inoculants. and soil amendments. Abo, the term 'plant
Compliance/Enforcement PIT ' Guidance Manual 1963
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Chapter One
FIFRA
P.L. M-3%:
P.L. M-3W:
TUSCIMc. IMo. IM.
7 USC IM>-4 MMC.
regulator' shall not be required to include any of such of those nutrient mix-
lures or soil amendments as are commonly known as vitamin-hormone hor-
ticultural products, intended for improvement, maintenance, survival, health,
and propagation of plants, and as are not for pest destruction and are non-
toxic, nonpoisonous in the undiluted packaged concentration.
"(w) Producer and Produce.—Tin term 'producer* means the person who
manufactures, prepares, compounds, propagates, or processes any pesticide or
device or active ingredient used in producing a pesticide. The term 'produce'
means to manufacture, prepare, compound, propagate, or process any
pesticide or device, or active ingredient used in producing a pesticide. The
dilution by individuals of formulated pesticides for their own use and accor-
ding to the directions on registered labels shall not of itself result in such in-
dividuals being included in the definition of 'producer' for the purposes of this
Act."
"(a) Protect Health and the Environment.—The terms 'protect health and
the environment' and 'protection of health and the environment' mean protec-
tion against any unreasonable adverse effects on the environment.
"(y) Registrant.—The term 'registrant' means a person who has registered
any pesticide pursuant to the provisions of this Act.
"(z) Registration.—The term 'registration' includes reregistration.
"(aa) Slate.—The term 'Slate* means a State, the District of Columbia, the
Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Trust Territory
of the Pacific Islands, and American Samoa.
"(bb) Unreasonable Adverse Effects on the Environment.—The term
'unreasonable adverse effects on the environment* means any unreasonable
risk to man or the environment, taking into account the economic, social, and
environmental costs and benefits of the use of any pesticide.
"(cc) ***«/.—The term 'weed' means any plant whkhjrows where not
"(dd) Establishment.—The term 'establishment' means any place where a
pesticide or device or active ingredient used in producing a pesticide is
produced, or held, for distribution or sale.
"(ee) To Use Any Registered Pesticide in a Manner Inconsistent With Its
Libeling.—The term 'to uscany registered pestiseide in a manner inconsistent
with its labeling'- means to use any registered pesticide in a manner not permit-
ted by the labeling: Provided, That the term shall not include (I) applying a
pesticide at any dosage, concentration, or frequency less than that specified on
the labeling, (2) applying a pesticide against any target pest not specified on
the labeling if the application b to the crop, animal, or site specified on the
labeling, unless the Administrator has required that the labeling specifically
state that the pesticide may be used only for the pests specified on the labeling
after the Administrator has determined that the use of the pesticide against
other pests would cause an unreasonable adverse effect on the environment,
(3) employing any method of appUcatica not prohifaited by the Jabetmg. or (4)
a.pfttiHnV or pfjtiodes with a ffTtjhrrf-when.SBciiJBO>ture is not pro-
bibbed by the labeling: Piovided further. That the term also shall not include
any use of a pesticide inconfonnance with section 3.18, or 24 of this Act, or any
use of a pesticide in a manner that the Administrator determines to be consis-
tent with the purposes of this Act: And provided further. That after March 31,
1979. the tern shall not include the use of a pesticide for agricultural or
forestry purposes at a dilution less than label dosage unless before or after that
date the Administrator issues a regulation or advisory opinion consistent with
the study provided for in section 27(b) of the Federal Pesticide Act of 1978,
which regulation or advisory opinion specifically requires the use of definite
amounts of dilution.
"(a) Requirement.— Except as otherwise provided by this Act, no person in
any State may distribute, sell, offer for sale, bold for sale, ship, ddrm for
shipment, or receive and (having so received) delivery or offer to deliver, to
any person any pesticide which is not registered with the Administrator.
"(b) Exemptions.— A pesticide which b not registered with the Ad-
ministrator may be transferred if—
"(1) the transfer is from one registered establishment to another
registered establishment °Pe™J*^_^r *** «ame .producer so/dy for
i jaisiiirti
"(2) the transfer is pursuant to and in accordance with the re-
quirements of an experimental use permit.
"(c) Procedure for Registration.—
(I) Statement required.— Etch applicant for registration of a
pesticide shall file with the Administrator a statement which includes—
snt
i-lo
Golda&ce Manual 1983
-------
MFEA
"(A) the name and address of the applicant and of any other per-
son whose name will appear on the labeling;
"(B) the name of (he pesticide;
"(C) a complete copy of the labeling of the pesticide, a statement
of all claims to be made for it, and any directions for its use;
"(D) except as otherwise provided in subsection (c)(2XD) of this
section, if requested by the Administrator, a full description of the
tests made and the results thereof upon which the claims are based,
or alternatively a citation to data that appears in the public literature
or that previously hadjwen submitted to the Administrator and that
the Administrator may consider in accordance with the following
provisions:
"(i) with respect to pesticides containing active ingredients that
are initially registered under this Act after September 30, 1978,
data submitted to support the application for the original registra-
tion of the pesticide, or an application for an amendment adding
any new use to the registration and that pertains solely to such
new use, shall not, without the written permission of the original
data submitter, be considered by the Administrator to support an
application by another person during a period of ten years follow-
ing the date the Administrator first registers the pesticides: Pro-
vided, That such permission shall not be required in the case of
defensive data;
"(ii) except as otherwise provided in subparagraph (DX>) of
this paragraph, with respect to data submitted after December 31,
1969, by an applicant or registrant to support an application for
registration, experimental use permit, or amendment adding a
new use to an existing registration, to support or maintain in ef-
fect an existing registration, or for reregistration, the Adminis-
trator may, without the permission of the original data submitter,
consider any such item of data in support of an application by any
other person (hereinafter in this subparagraph referred to as the
'applicant') within the fifteen-year period following the date the
data were originally submitted only if the applicant has nude an
offer to compensate the original data submitter and submitted
such offer to the Administrator accompanied by evidence of
delivery to the original data submitter of the offer. The terms and
amount of compensation may be fixed by agreement between the
original data submitter and the applicant, or, failing such agree-
ment, binding arbitration under this subparagraph. If, at the end
of ninety days after the date of delivery to the original data sub-
mitter of the offer to compensate, the original data submitter and
the applicant have neither agreed on the amount and terms of
compensation..nor on a procedure for reaching an agreement on
the amount and terms of compensation, either person may initiate j
binding arbitration proceedings by requesting the Federal Media- i
lion and Conciliation Service to appoint an arbitrator from the j
roster of arbitrators maintained by such Service. The procedure |
and rules of the Service shall be applicable to the selection of such ;
arbitrator and to such arbitration proceedings, and the findings
and determination of the arbitrator shall be final and conclusive,
and no official or court of the United States shall have power or
jurisdiction to review any such findings and determination, except
. for fraud, misrepresentation, or other misconduct by one of the
. panics to the arbitration or the arbitrator where there is a verified
[ complaint with supporting affidavits attesting to specific in-
* stances of such fraud, misrepresentation, or other misconduct.
The parties to the arbitration shall share equally in the payment of
the fee and expenses of the arbitrator. If the Administrator deter-
mines that an original data submitter has failed to participate in a
procedure for reaching an agreement or in an arbitration pro-
ceeding as required by this subparagraph, or failed to comply with
the terms of an agreement or arbitration decision concerning
compensation under this subparagraph, the original data submit-
ter shall forfeit the right to compensation for the use of the data
in support of the application. Notwithstanding any other provi-
sion of this Act, if the Administrator determines that an applicant
P.L. 9J.J96:
92Sl«l. 120.
(Set note
|