ENFORCEMENT RESPONSE POLICY
FOR THE
FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT (FIFRA)
Office of Compliance Monitoring
Office of Pesticides and Toxic Substances
U.S. Environmental Protection Agency
July 2, 1990
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TABLE OF CONTENTS
INTRODUCTION !
OVERVIEW OF THE POLICY 2
DETERMINING THE LEVEL OF ACTION .3
Notices of Detention 4
Notices of Warning 4
Section 14(a)(2) Notices of Warning 4
Sections 9(c)(3) and 14(a)(4) 5
Stop Sale, Use, or Removal Orders (SSURO) 5
Mandatory Issuance of a SSURO 6
Discretionary Issuance of a SSURO 7
Use of a SSURO for Minor violations 7
Seizures 7
Injunctive Relief 8
Civil Administrative Penalties 9
Denials, Suspensions, Modifications, or
Revocations of Applicator Certifications 10
Denial/Revocations 11
Suspensions 11
Criminal Proceedings 12
Parallel Criminal and Civil Proceedings 13
State and Federal Roles in Criminal Enforcement
of FIFRA 13
FIFRA's Relationship to Other Federal
Criminal Laws 14
Recalls 14
Voluntary and Mandatory Recalls 14
Formal and Informal Recalls 15
Press Releases/Advisories 16
ASSESSING ADMINISTRATIVE CIVIL PENALTIES 17
Computation of the Penalty 17
Use of the FIFRA Civil Penalty Matrix 18
Table 1 19
Size of Business 20
Table 2 20
Gravity of the Violation 21
Table 3 22
Gravity Adjustments for RecordJceeping and
Reporting Violations 22
Ability to Continue in Business/Ability to Pay 23
4% of Gross Sales 23
ABEL 23
Independently Assessable Charges 25
Voluntary Disclosure 26
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Adjusting the Proposed Civil Penalty in Settlement 26
Factual Changes . . 27
Negotiations Involving Only the Amount of
the Penalty .27
Good Faith Adjustment 27
Special Circumstances/Extraordinary Adjustments ....28
Settlement With Conditions (SWC) 28
Criteria for Choosing an SWC 29
Responses to Noncompliance With an SWC 30
Penalty Payment 30
Reinspection and Additional Enforcement 30
Elements of an SWC 30
APPENDIX A - FIFRA CHARGES AND GRAVITY LEVELS . . A-l
APPENDIX B - GRAVITY ADJUSTMENT CRITERIA B-l
APPENDIX C - SUMMARY OF TABLES C-l
APPENDIX D - FIFRA CIVIL PENALTY CALCULATION WORKSHEET D-l
PROGRAM SPECIFIC SUPPLEMENTS TO THE FIFRA ERP
ERP for the FIFRA Section 7(c) Pesticide Producing
Establishment Reporting Requirements
ERP for the FIFRA Good Laboratory Practice Standards ....
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07/02/90
ENFORCEMENT RESPONSE POLICY FOR THE
FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT (FIFRA)
INTRODUCTION
This document sets forth the procedures and criteria that will be used to
determine the appropriate enforcement response for violations of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). The FIFRA Enforcement
Response Policy (ERP) is designed to provide fair and equitable treatment of the
regulated community by ensuring that similar enforcement responses and comparable
penalty assessments will be made for comparable violations. The policy is designed to
provide for swift resolution of environmental problems and to deter future violations of
FIFRA by the respondent as well as other members of the regulated community.
This policy supersedes the previous FIFRA Civil Penalty Assessment Guidelines
published in the Federal Register on July 31, 1974 (39 FR 27711). There have been
many amendments to the statute, as well as EPA rulemaking, since the 1974 FIFRA
Civil Penalty Assessment Guidelines, which are incorporated into this revised FIFRA
ERP. Also superseded by this FIFRA ERP are: the 1983 Level of Action Policy
published as section 2 of Chapter 5 of the FIFRA Compliance/Enforcement Guidance
Manual; the June 8, 1981 Guidance for the Enforcement of the Child-Resistant
Packaging Regulation; and the June 11, 1981 FIFRA Enforcement Policy - Interim
Penalty Guidelines.
Except for the civil penalty assessment matrix, the February 10, 1986 FIFRA
Section 7(c) Enforcement Response Policy remains in effect, and is to be used to
determine the appropriate enforcement response for FIFRA section 7(c) violations.
The matrix setting forth the penalties in this policy should be used instead of the
matrix in the February 10, 1986 policy. Additional supplements to the FIFRA ERP
will be forthcoming which will more clearly discuss the appropriate enforcement
response for violations of other specific program requirements, such as the FIFRA
Good Laboratory Practice (GLP) Standards and the FIFRA section 19 regulations.
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OVERVIEW OF THE POLICY
This FIFRA Enforcement Response Policy (ERP) is divided into three main
sections. The first section, "Determining the Level of Action," briefly describes the
Agency's options for responding to violations of FIFRA. Section 2 of this ERP,
"Assessing Administrative Civil Penalties," elaborates on the Agency's policy and
procedures for calculating civil penalties to be assessed against .persons who violate
FIFRA. Section 2 also contains the Agency's policy for negotiating a "settlement with
conditions" for civil penalties issued under FIFRA. The third section of this policy
contains the appendices necessary for calculating civil penalties. The four
appendices to this ERP are: (1) Appendix A - FIFRA Charges and Gravity Levels;
(2) Appendix B - Gravity Adjustment Criteria; (3) Appendix C - The Summary of
Tables; and, (4) Appendix D - The FIFRA Civil Penalty Calculation Worksheet.
Guidance on the appropriate enforcement response for violations of specific
FIFRA programs, such as the FIFRA Good Laboratory Practice Standards,* FIFRA
section 19 recall requests,* or FIFRA section 7(c) Pesticide Producing Establishment
Reporting Requirements, should be attached as additional appendices, and used in
conjunction with the overall FIFRA ERP.
Enforcement response policies for the Good Laboratory Practice Standards, and the FIFRA section 19 regulations
will be forthcoming.
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DETERMINING THE LEVEL OF ACTION
Once the documentation of a FIFRA*violatir - is complete, the appropriate level
of action called for by the severity of the violation needs to be selected. These levels
of response include:
o Notices of Detention under section 17(c);
o Notices of Warning under sections 9(c)(3), 14(a)(2), and 14(a)(4);
o Stop Sale, Use, or Removal Orders under section 13(a);
o Seizures under section 13(b);
o Injunctions under section 16(c);
o Civil administrative penalties under section 14(a);
o Denials, suspensions, modifications, or revocations of
applicator certifications under 40 CFR Part 171;
o Criminal referrals under section 14(b); and
o Recalls.
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Notices of Detention
A shipment of a pesticide or device being imported into the United States
cannot be brought into the country until EPA makes a determination of the
admissibiliry of that shipment. However, under the U.S. Customs' regulations for the
enforcement of section 17(c) of FIFRA (19 CFR Pan 12.110 - 12.117), subsequent to
the receipt of a Notice of Arrival completed by the Administrator, the District Director
of Customs may release a shipment to the importer or the importer'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. When a shipment of
pesticides is released under bond, the shipment may not be used or otherwise disposed
of until the Administrator has determined the admissibility of that shipment. Should
the shipment subsequently be refused entry and the importer or agent fails to return
the pesticide or device, the bond is forfeited.
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. If the
consignee has not requested a hearing, or has not exported the pesticide or device
within 90 days from the date of the notice, the Customs Service will oversee destruction
of the pesticide or device.
Notices of Warning ;
FIFRA sections 14(a)(2), 14(a)(4), and 9(c)(3) provide EPA with the authority
iu respond 10 certain violations of FIFRA with a Notice of Warning to the violator.
Section 14(a)(2) Notices of Warning
Under section 14(a)(2) of FIFRA, a written warning for a violation of FIFRA
must be issued to a private applicator or other person not covered by section 14(a)(!)
prior to the assessment of a civil penalty. Applicators who apply a registered general
use pesticide as a service in controlling pests but who do not deliver any unapplied
pesticides ("for hire" applicators), are also included in section 14(a)(2) but are not
subject to this limitation. A "for hire" applicator may be assessed a penalty up to $500
for the first offense.
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Sections 9(cV3) and 14faV4)
Section 14(a)(4) of FIFRA states that EPA may choose to issue a Notice of
Warning in lieu of a civil penalty if EPA determines that the violation occurred despite
the exercise of due care or the violation did not cause significant harm to health or the
environment. Section 9(c)(3) also permits the EPA to issue i written Notice of
Warning in lieu of instituting a proceeding for minor violations of FIFRA if the
Administrator believes that the public interest will be adequately served through this
course of action.
Generally, a violation will be considered minor, and a section 9(c)(3) notice of
warning may be issued in lieu of a civil complaint if the total "gravity adjustment
value", as determined from Appendix B of this ERP, is less than three (see the section
of this ERP entitled "Gravity of the Violation" and Appendix B, "Gravity Adjustment
Criteria"). A Notice of Warning may also be appropriate for certain first-time record
keeping violations as listed in Appendix A of this ERP (e.g., late section 7 reports).
Stop Sale. Use, or Removal Orders fSSURO)
Section 13 of FIFRA provides EPA the authority to issue a Stop Sale, Use, or
Removal Order (SSURO) to any person who owns, controls, or has custody of a
pesticide or device, whenever EPA has reason to believe on the basis of inspection or
tests that: (1) a pesticide or device is in violation of any provision of the Act; (2) a
pesticide or device has been or is intended to be distributed in violation of the Act; or,
(3) when a registration of a pesticide has been cancelled by a final order or has been
suspended. A civil penalty should generally be assessed in addition to the SSURO
when a violation of FEFRA has occurred.
A SSURO is among the most expedient and effective remedies available to EPA
in its efforts to prevent illegal sale, distribution, and use of pesticides. Its advantages
over other actions (such as seizures) are that: (1) it may be issued whenever EPA has
reason to believe that the product is in violation of the Act; (2) it is easier to prepare
and issue than a seizure; (3) the SSURO has an effect on all of the product under the
ownership, custody, or control of the individual receiving the SSURO regardless of
where the product is located; (4) the SSURO can be written so as to include future
amounts of the product that may come into custody of the person on whom the
SSURO is served; and, (5) it can easily be adapted to particular circumstances.
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As per the FIFRA Compliance Program Policy Number 3.9, issued on July 6,
1987, when a SSURO is issued to a basic registrant with regard to a registered
pesticide product, the terms of the SSURO are equally applicable to the supplemental
registrants of the product.
Mandatory Issuance of a SSURO
A SSURO is to be issued against persons who own, control, or have custody of
pesticides in the following categories:
Pesticides for which there is reason to believe that there is a potential hazard to
man or the environment because: (1) they are not registered, or are so over-
formulated, underformulated, or adulterated, as to present a serious health
hazard; or, (2) they are packaged in improper or damaged containers, or are so
inadequately labeled, as to make safe or effective use unlikely or impossible.
Pesticides or devices with labeling that is materially misleading or fraudulent, and
if followed by a user, is likely to cause a life-endangering health hazard or
serious adverse environmental effects (a pesticide lacking a restricted use label is
an especially serious labeling violation). This provision includes labeling for
products that: (1) are ineffective for the purposes claimed; (2) are so chemically
deficient as to affect deleteriously the product's efficacy; or, (3) bear false or
misleading safety claims.
Pesticides or hazardous devices* that are in violation of the Act and are the
subject of a recall, but which the responsible party refuses to remove, is
recalcitrant in removing, or is unable to remove from the channels of trade.
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.
Pesticides which have been suspended under FIFRA section 6.
A hazardous device » one presenting a direct threat to human health or the environment by its uae (e-g, a water treatment device
whose labeling make* (ate, misleading, or fraudulent claims to purity raw well water or other1 untreated water supplies). For
nonhazardous devices (e.g., an electromagnetic rodent repelling device) thai are misbranded. Agency, policy is to complete civil penalv
proceedings before issuing a SSURO. See December 19. 1979 Memorandum: 'Enforcement Actions Concerning Non hazardous
Pesticide Devices."
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Discretionary Issuance of a SSURO
The EPA may also issue a SSURO in cases where there is reason to believe a
product either is in violation of the Act or that the product has been 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. The EPA may also issue a
SSURO if a product has been cancelled under any section of the Act, or suspended
under FIFRA sections 4 or 3(c)(2)(B), and the existing stock deadlines have occurred
at that level of sale, distribution, or use.
Use of a SSURO for Minor Violations
While EPA will usually reserve the use of a SSURO for relatively serious
violations, the need to issue a 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 on the label, EPA may decide to issue a SSURO
to ensure that the product will be distributed or sold in compliance with the Act.
Seizures
Section 13(b) of FIFRA gives EPA the authority to initiate in rem condemnation
proceedings in U.S. District Court. Once a Court grants the Agency's request for
authority to conduct a seizure, FIFRA section 9(b)(3) authorizes officers or employees
duly designated by the Administrator to obtain and execute warrants for the purpose of
seizing any pesticide or device that is in violation of the Act. Seizures may be
executed with the assistance of the U.S. Marshal.
Under FIFRA section 13(b), EPA may initiate seizure actions in District Court
against 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 country, if: (1) a pesticide is adulterated
or misbranded; (2) a pesticide is unregistered; (3) a pesticide has labeling which does
not bear the information required by the Act; (4) a pesticide is not colored or
discolored as required; (5) a pesticide bears claims or directions for use that differ
from those made in connection with its registration; (6) a device is misbranded; or,
(7) a pesticide or device causes unreasonable adverse effects upon the environment,
even when used in accordance with the requirements imposed by the Act.
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The previous examples are similar to those circumstances that would lead the
Agency to issue a SSURO. Because a SSURO can be issued in less time and with less
preparation than that required for a seizure, the SSURO is the preferred enforcement
remedy in terms of expediency. Nevertheless, the Agency should consider initiating a
seizure in the following circumstances:
o The Agency has issued a SSURO, but the recipient of the order has not
complied with it;
o The Agency has reason to believe that a person, if issued a SSURO, will not
comply with it;
o There exists a pesticide so hazardous that it should be removed from the
marketplace, place of storage, or place of use to prevent any chance of
harm to human health or the environment;
o The seizure will be used to support a recall; or
o It is necessary to dispose of products being held under a SSURO for which
the responsible party has taken no corrective action and has expressed an
intent not to take corrective action.
fnjunctive Relief
Section 16(c) of FIFRA gives EPA the authority to initiate injunctive actions
before the U.S. District Court. These actions may consist of permanent injunctions,
preliminary injunctions, or temporary restraining orders.
Because an injunction is an extraordinary form of reiief, the Agency's arguments
must be clear and compelling. In initiating a permanent injunction action, EPA must
indicate to the court that: (1) the Agency's administrative or other judicial enforcement
remedies would be inadequate either at restraining the violation or at preventing
unreasonable risk to human health or the environment; (2) the Agency has already
diligently exercised all appropriate administrative remedies (such as SSUROs and
civil penalties), yet the violation or threat of a violation continues unabated; or
(3) irreparable injury, loss, or damage will result if the relief sought is not granted.
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In the case of a preliminary injunction or temporary restraining order, the
Agency must additionally demonstrate that: (1) immediate and irreparable injury, loss,
or damage will result if the requested relief is not granted; and, (2) there is a
likelihood of Agency success at trial, based on the 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:
o The violation of a section 6 suspension or cancellation order;
o The violation of a SSURO where a civil penalty or criminal prosecution
would not provide a timely or effective remedy to deter further violations;
o There is continued production (in violation of the FIFRA section 7
requirements), shipment, sale, distribution, or use of an unregistered
pesticide after the Agency has taken civil or criminal action;
o A person continues to sell, distribute, or make available for use a restricted
use pesticide (RUP) other than in accordance with FIFRA section 3(d),
after the Agency has already exercised an enforcement remedy;
o A person continues to violate the FIFRA section 17 import or export
requirements after the Agency has already exercised an enforcement remedy;
and,
o A person continues to use a pesticide in a manner inconsistent with its
labeling, in a manner contrary to an experimental use permit, or repeats any
violation of FIFRA, after the Agency has already exercised an enforcement
remedy.
Civil Administrative Penalties
FIFRA section 14(a)(l) states that a registrant, commercial applicator,
wholesaler, dealer, or other distributor may be assessed a civil penalty of up to $5,000
for each violation of FIFRA. Section 14(a)(2) allows the Administrator to assess a
private applicator or other person up to $1,000 for each violation of FIFRA,
subsequent to receiving a Notice of Warning or a citation for a prior violation (the
prior warning or citation may have been for the same or different FIFRA violation).
Additionally, section 14(a)(2) states that an applicator who applies a registered general
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use or unclassified pesticide as a service in controlling pests but does not deliver any
unapplied pesticide (a "for hire applicator") may be assessed a civil penalty of not more
than 5500 for the first offense of FIFRA, and $1,000 for each subsequent offense.*
A civil penalty is the preferred enforcement remedy for most violations. A civil
penalty is appropriate where the violation: (1) presents an actual or potential risk of
harm to humans or the environment (SSUROs or injunctive relief should be pursued in
addition to a civil penalty if the harm is extreme or imminent), or would impede the
Agency's ability to fulfill the goals of the 'statute; (2) was apparently committed as a
result of ordinary negligence (as opposed to criminal negligence), inadvertence, or
mistake; and the violation either: (a) involves a violation under the Act by any
registrant, commercial applicator, "for hire" applicator, wholesaler, dealer, retailer, or
other distributor (no prior warning is required by FIFRA for violators in this category);
or, (b) involves a private applicator or other person not listed in above and who has
received a prior warning or citation for a FIFRA violation.
Denials, Suspensions, Modifications, or Revocations
of Applicator Certifications
The regulations relating to the- certification of pesticide applicators (40 CFR Part
171) authorize EPA to deny, suspend, or revoke a federally issued applicator
certification if the holder of the certification 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 CFR Section 171.1 l(f)(5)(i)]. Therefore, EPA will deny,
suspend, modify, or revoke a federal certification only in response to serious violations
or against persons with a history of noncompliance.
Any applicator, including a Tor hire applicator", who hotda or applies an unregistered pesticide to provide a service of
controlling pests without delivering any unapplied pesticide to any penon so served, will be considered a distributor of
pesticide* and will be subject to the higher penalties set forth in sections 14
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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 at least six months following denial or revocation. Therefore. EPA
will deny or revoke a certification where: (1) a violation resulted in a fatality or created an
imminent danger of a fatality; (2) a violation resulted in severe damage to the environment
or created an imminent danger of severe damage to the environment; (3) a misuse
violation has resulted in significant contamination of food and water; (4) the violator's
certification has been suspended as a result of a previous serious violation; or (5) a person
has maintained or submitted fraudulent records or reports.
If EPA pursues an action to deny, revoke, or modify an applicator's certification,
EPA will notify the applicant or federal certificate holder of: (1) the ground(s) upon which
the denial, revocation, or modification is based; (2) the time period during which the
denial, revocation, or modification is effective, whether permanent or otherwise; (3) the
conditions, if any, under which the individual may become certified or recertified; and
(4) any additional conditions EPA may impose. EPA must also provide the federally
certified applicator an opportunity to request a hearing prior to final Agency action to
deny, revoke, or modify the certificate.
Suspensions
Generally, the Agency will pursue the less severe alternative of suspending an
applicator's federal certification in response to violations by applicators who have
previously been issued a civil complaint for a violation of FIFRA. The Agency will
suspend an applicator's certification for up to four months for the second independent
violation of FIFRA.* For each additional violation, two months may be added to the
term of suspension up to a limit of eight months. The exact length of the suspension
(within the limits stated above) should result in an economic loss to the applicator of at
least the statutory maximum civil penalty that could have been assessed.
For purpoaea of thia section of the policy, EPA will not diatingiwa between commercial and private applicator*.
Cboaideratioa of applicator sutua ia inherent in the policy in that tuapenaiona have a more wibauntial impact on
commercial applicator*, affecting their primary buaineaa activity.
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If EPA decides to suspend certification, it must notify the applicator of the
grounds upon which the suspension is based, and 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.
Generally, a suspension is pursued against an individual applicator for a
subsequent offense in addition to the issuance of a civil penalty against the employer.
EPA may also suspend certifications of commerciaJ applicators who violate
restricted use pesticides recordkeeping requirements [see 40 CFR 171.11(c)(7); 40 CFR
171.11(f)(l)(iii)|. 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 certification in response to the initial
infraction.
Criminal Proceedings
Section 12 of FIFRA specifically lists the unlawful acts that are subject, not only
to civil and administrative enforcement, but also to criminal investigation and penalties
(see Chapter 20, "FIFRA Criminal Enforcement," of the Pesticides Inspection Manuall.
Section 14(b) of FIFRA (7 U.S.C 1361) provides the authority to proceed with
criminal sanctions against violators of the Act, as follows:
o A registrant, applicant for a registration, or producer who knowingly violates
the Act is subject, upon conviction, tc a fine of not more than $50,000 or
imprisonment for up to 1 year, or both.
o A commercial applicator of a restricted use pesticide, or any other person
not described above who distributes or sells pesticides or devices, who
knowingly violates the Act is subject, upon conviction,, to a fine of not more
than $25,000 or imprisonment for up to 1 year, or both.
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A private applicator or other person not included above who knowingly
violates the Act is subject, upon conviction, to a fine of not more than
S 1,000, or imprisonment for not more than 30 days, or both.
In addition, pursuant to the Alternatives Fines Act (18 U.S.C. 3571) the FIFRA
criminal fine amounts may be substantially increased if the violation results in death.
All acts of the regulated community exhibiting actual or suspected environmental
criminal conduct should be discussed with EPA Regional or Headquarter's Criminal
Enforcement Counsel or to the Office of Criminal Investigations for an assessment and
possible investigation.
Parallel Criminal and Civil Proceedings
Civil/administrative and criminal enforcement actions may be conducted
simultaneously whenever deemed necessary by the EPA Assistant Administrator for the
Office of Enforcement in order to seek immediate relief to protect human health or
the environment. Simultaneous civil actions and criminal proceedings may be
appropriate if the environmental consequences of a violation pose a hazard requiring
remedial measures by a defendant.
The State and Federal Roles in Criminal Enforcement of FIFRA
State primacy for pesticide use violations, under FIFRA sections 26 and 27, also
applies to criminal FIFRA use violations. States are initially allowed 30 days to
commence appropriate enforcement actions for such violations. However, criminal
violations which do not constitute pesticide use violations may be investigated and
prosecuted on the Federal level without waiting for State authorities to exercise their
primary enforcement responsibility. The State should be informed of any criminal
investigation being conducted within their State.
Violations of a cancellation or suspension order, an EPA stop sale, use, or
removal order (SSURO), fraudulent labeling, advertising, or registration of a pesticide
are among those types of FIFRA violations for which States do not have primary
enforcement authority. Even where there is a FIFRA pesticide use violation, the States
can choose to waive their primary enforcement responsibility to allow Federal criminal
enforcement action to be undertaken.
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FIFRA's Relationship to Other Federal Criminal Laws
Possible criminal environmental offenses should be brought promptly to the
attention of EPA Criminal Enforcement Counsel, Special Agents in the Office of
Criminal Investigations, or the appropriate state authorities. This is true even if the
suspected criminal activity does not appear to be a violation of FIFRA. The criminal
conduct may also be amenable to prosecution under one of the other environmental
laws or one of the general criminal laws.
For instance, submission of false registration information may not only constitute
a violation of FIFRA, but also the Federal false statement statute and conspiracy laws.
The unlawful disposal of pesticides may be a criminal violation of the Resource
Recovery and Conservation Act (RCRA) or, if the disposal was into a river, such
conduct could be a criminal violation of the Clean Water Act. Which statute to
proceed under may not be decided until the investigation is almost complete and may
depend on factors such as the evidence available to establish an offense and the
different penalty levels of the involved statutes.
Recalls
In general, under FIFRA sections 19(b)(3) and (4), if a registration of a
pesticide has been suspended and cancelled, and EPA finds that a recall is necessary to
protect public health or the environment, EPA will request that a voluntary or
mandatory recall be conducted. Additionally, the EPA will continue its policy of
initiating formal and informal recalls in cases where a product is either potentially
hazardous when used as directed, ineffective for the purposes claimed, or violative in
nature. Formal and informal recalls are not authorized under the statute. Therefore,
the effectiveness of a formal or informal recall action is contingent on the cooperation
of the company involved.
Voluntary and Mandatory Recalls
A voluntary recall may be appropriate if a product is suspended and cancelled
and the voluntary recall will be sufficient to protect human health or the environment.
If not, mandatory recall procedures issued as a regulation under FIFRA sections
19(b)(3) and (4) may require registrants, distributors, or sellers of a pesticide to recall
the pesticide; to make available storage facilities to accept and store existing stocks of
the suspended and cancelled pesticide; to inform the EPA of the location of the
storage facility; and to inform the EPA of the progress of the recall. The panics
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subject to the recall must also provide transportation of the pesticide, on request; and
take reasonable steps to inform holders of the recall and transportation provisions.
Persons conducting the recall must comply with transportation, storage and disposal
requirements. The criteria for the recall plans will be issued under FIFRA section
19(b) through the 40 CFR Part 165.
Formal and Informal Recalls ,
The Agency should consider a formal or informal recall of a product when,
among other things, its use as directed by the label is likely to result in: (1) injury to
the user or handler of the product; (2) injury to domestic animals, fish, wildlife, or
plant life; (3) physical or economic injury because of ineffectiveness or due to the
presence of actionable residues; or (4) identifiable adverse effects on the environment.
A product does not have to be suspended or cancelled in order for EPA to decide that
requesting a formal or informal recall is appropriate.
A formal or informal recall must only be requested where the evidence clearly
supports the need for 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 analysis, staff evaluations and opinions, and such other information as may
be available. All information supporting a recall decision must be included in the
official file.
Formal recalls are used for more serious problems and when it is essential that
EPA regional personnel follow-up the recall with a visit to the company. Formal recall
involves EPA monitoring, detailed reporting by the company involved, and notification
to State officials. This type of recall is normally accompanied by another enforcement
action, generally a civil penalty.
An informal recall should be used in cases where a recall is necessary but the
level of potential hazard is not great or when it is unlikely that significant amounts of
the defective product remain in the marketplace. An informal recall is conducted
entirely by the company involved with no monitoring by EPA or State officials.
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Press Releases/Advisories. Etc.
Regions may, at their discretion, issue a press release/advisory to notify the public
of a person's violation of FIFRA. However, the issuance of press release/advisory must
not be an item of negotiation during settlement.
A press release/advisory can be a useful tool to notify the public of a person's
noncompliance with FIFRA and to educate the public on the requirements of FIFRA.
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ASSESSING ADMINISTRATIVE CIVIL PENALTIES
FIFRA section 14(a)(l) states that a registrant, commercial applicator, wholesaler,
dealer, or other distributor may be assessed a civil penalty of up to $5,000 for each
violation of FIFRA. Section 14(a)(2) allows the Administrator to assess a private
applicator or other person up to $1,000 for each violation of FIFRA, subsequent to
receiving a Notice of Warning or a citation for a prior violation. Additionally, section
14(a)(2) states that an applicator who applies a registered general use pesticide as a
service in controlling pests but does not deliver any unapplied pesticide (a "for hire
applicator") may be assessed a civil penalty of not more than $500 for the first offense
of FIFRA, and $1,000 for each subsequent offense.
Additionally, as the statutory definitions of "distribute or sell" and "commercial
applicator" indicate, and as the conference report for the Federal Pesticide Act of 1978
confirms (Senate Report No. 95-1188; September 12, 1978; page 44 and 45), any
applicator, including a "for hire" applicator, who holds or applies an unregistered
pesticide to provide a service of controlling pests without delivering any unapplied
pesticide to any person so served, will be considered a distributor of pesticides and will
be subject to the higher penalties set forth in sections 14(a)(l) and 14(b)(l) of FIFRA.
Additionally, any applicator, other than a private applicator, who uses or supervises the
use of a restricted use pesticide (RUP), whether or not that applicator is certified, is a
commercial applicator and is subject to the higher penalties set forth in sections
14(a)(l) and 14(b)(l) of FIFRA Finally, any applicator, even if that applicator is
certified, who holds or applies a general use pesticide (GUP) or an unclassified
pesticide in violation of FIFRA will be subject to the lower penalties set forth in
FIFRA sections 14(a)(2) and 14(b)(2).
The FIFRA Civil Penalty System - Computation of the Penalty ,
In determining the amount of the civil penalty, section 14(a)(4) of FIFRA requires
the Agency to consider the appropriateness of the penalty to the size of the business of
the person charged, the effect of the penalty on the person's ability to continue in
business, and the gravity of the violation.
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Computation of the penalty amount is determined in a five stage process in
consideration of the FIFRA section 14(a)(4) criteria listed above. These steps are:
(1) determination of gravity or "level" of the violation using Appendix A of this ERP;
(2) determination of the size of business category for the violator, found in
T-ible 2; (3) use of the FIFRA civil penalty'matrices found in Table 1 to determine the
dollar amount associated with the gravity level of violation and the size of business
category of the violator; (4) further gravity adjustments of the base penalty in
consideration of the specific characteristics of the pesticide involved, the actual or
potential harm to human health and/or the environment, the compliance history of the
violator, and the culpability of the violator, using the "Gravity Adjustment Criteria"
found in Appendix B; and, (5) consideration of the effect that payment of the total
civil penalty will have on the violator's ability to continue in business, in accordance
with the criteria established in this ERP. A proposed civil penalty may be further
modified during the course of settlement negotiations in accordance with the section of
this ERP entitled "Adjusting the Proposed Civil Penalty in Settlement."
Use of the FIFRA Civil Penalty Matrix
The gravity of the violation and the size of the business are considered in the
FIFRA Civil Penalty Matrices shown in Table 1. Each cell of the matrix represents the
Agency's assessment of the appropriate civil penalty, within the statutory maximum, for
each gravity level of a violation and for each size of business category. Since FIFRA
imposes different statutory ceilings on the maximum civil penalty that may be assessed
against persons listed in FIFRA section 14(a)(l) and persons listed in section 14(a)(2),
this policy has separate penalty matrices for section 14(a)(l) violators and section
14(a)(2) violators.
The section 14(a)(2) penalty matrix will only be used by the Agency for persons
falling under FIFRA section 14(a)(2) who have previously been issued a notice of
warning or civil complaint (FIFRA section 14(a)(2) states that private applicators are
only subject to civil penalties subsequent to receiving a Notice of Warning or following
a citation for a prior violation, and "for hire" applicators are only subject to a
maximum $500 civil penalty for their first offense of FIFRA). The Agency has only
included three levels in the section 14(a)(2) Civil Penalty Matrix, rather than the four
levels provided in the section 14(a)(l) matrix This is because the Agency does not
believe that the lower base penalty figure that can be obtained from a "level 4" is
appropriate for violations of the statute committed after the receipt of a notice of
warning or civil complaint.
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When a civil penalty is the appropriate response for a first-time violation by a
"for hire applicator" who violates any provision of FIFRA while holding or applying a
registered general use pesticide or a registered unclassified pesticide, that civil penalty
will be the statutory maximum of $500. Subsequent violations will be assessed using
the FIFRA section 14(a)(2) civil penalty matrix below.
TABLE 1
CIVIL PENALTY MATRIX
FOR FIFRA SECTION 14(a)(l)
SIZE OF BUSINESS
LEVEL
level 1
level 2
level 3
level 4
I
5,000
5,000
4,000
3,000
II
5,000
4,000
3,000
2,000
III
5,000
3,000
2,000
1,000
CIVIL PENALTY MATRIX
FOR FIFRA SECTION 14(a)(2) *
SIZE OF BUSINESS
LEVEL
level 1
level 2
level 3
I
1,000
1,000
800
II
1,000
800
600
III
1,000
600
500
This 14(«X2) matrix t* only for me io determining civi] penalties iuued subsequent to a notice of warning or following a
citation for a prior violation, or in the cate of a "for hire" applicator using a registered general use pesticide, subsequent
to the issuance of a civil penalty of $500.
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Size of Business
In order to provide equitable penalties, the civil penalties that will be assessed
for violations of FIFRA will generally decrease as the size of the business decreases,
and vice versa. Size of business is determined from an individual's or .a company's
gross revenues from all revenue sources during the prior calendar year. If the revenue
data for the previous year appears to be unrepresentative of the general performance
of the business or the income of the individual, an average of the gross revenues for
the three previous years may be used. Further, the size of business and gross revenue
figures are based on the entire corporation rather than a specific subsidiary or division
of the company which is involved with the violation (including all sites owned or
controlled by the foreign or domestic parent company), unless the subsidiary or division
is independently owned.
As shown in the FIFRA Civil Penalty Matrices in Table 1, the appropriateness
of the penalty to the size of the business of the person charged is based on three
distinct "size of business" categories. Further, because the gross revenues of the
persons listed in FIFRA section 14(a)(l) [registrants, commercial applicators,
wholesalers, dealers, retailers, or other distributors] will generally be higher than the
gross incomes of the persons listed in FIFRA section 14(a)(2) [private applicators and
other persons not listed in 14(a)(l)], the policy has separate "size of business"
categories for FIFRA section 14(a)(l) persons and section 14(a)(2) persons. The "size
of business" categories for FIFRA section 14(a)(l) and section 14(a)(2) violators are
listed in Table 2.
/
TABLE 2
For section 14(a)(l) violators, the size of business categories are:
T - over $1,000,000
II - $300,001 - $1,000,000
III - $0 - $300,000
For section 14(a)(2) violators, the categories are:
I - over $200,000
II - $50,001 - $200,000
III - $0 - $50,000
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When information concerning an alleged violator's size of business is not readily
available, the penalty is to be calculated using the Category I size of business. The
Category Isize of business will remain the base penalty value unless the violator can
establish, at their expense and to the Agency's satisfaction, that it should be considered
in a smaller size of business category.
Gravity of the Violation
Determination of the gravity of the violation is a two step process:
(1) determination of the appropriate "gravity level" that EPA has assigned to the
violation, and (2) the adjustment of that base penalty figure, as determined from the
gravity level, to consider the actual set of circumstances that are involved in the
violation.
The gravity "level" established for each violation of FIFRA is listed in
Appendix A of this ERP. The "levels" assigned to each violation of FIFRA represents
an assessment of the relative gravity of each violation. The relative gravity of each
violation is based on an average set of circumstances which considers the actual or
potential harm to human health and/or the environment which could result from the
violation, or the importance of the requirement to achieving the goals of the statute.
The gravity level, which is determined from the chart in Appendix A, is then used to
determine a base penalty figure from the FIFRA Civil Penalty Matrices.
As the actual circumstances of the violation differ from the "average"
circumstances assumed in each gravity level of the Civil Penalty Matrices, the dollar
amount derived from the matrix should be adjusted upward or downward. The Agency
has assigned adjustments, based on the gravity adjustment criteria listed in Appendix B,
for each violation relative to the specific characteristics of the pesticide involved, the
harm to human health and/or harm to the environment, compliance history of the
violator, and the culpability of the violator. Under the FIFRA civil penalty system, the
gravity adjustment values from each gravity category listed in Appendix B are to be
totaled. The dollar amount found in the matrix will be raised or lowered, within the
statutory maximum ($5,000 for section 14(a)(l) persons and $1,000 for 14(a)(2)
persons), based on the total gravity values in Table 3.
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TABLE 3
Total Gravity Value
Enforcement Remedy
3 or below
4
5
6
7
8 to 12
13
14
15
16
17 or above
No action. Notice of Warning, or
50% reduction of matrix value.*
Reduce matrix value 40%
Reduce matrix value 30%
Reduce matrix value 20%
Reduce matrix value 10%
Assess matrix value
Increase matrix value 10%**
Increase matrix value 15%**
Increase matrix value 20%**
Increase matrix value 25%**
Increase matrix value 30%**
* 50% reduction of matrix value is recommended where multiple count violations exist.
* * Matrix value can only be increased to tne statutory maximum of $5,000 per offense for
penoos under FIFRA section 14(aXl)i "d $1,000 for persons under FIFRA section 14<*X2)-
Gravity Adjustments for Recordkeeping and Reporting Violations
The gravity of recordkeeping and reporting violations are already considered in
the dollar amounts presented in the FIFRA civil penalty matrices. Further,
recordkeeping and reporting violations do not lend themselves to utilizing the gravity
adjustments listed in Appendix B. Therefore, first-time civil penalties should be
assessed at the matrix value, while subsequent penalties should be increased by an
increment of 30% (up to the statutory maximum).
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Abilitv to Continue in Business/Ability to Pay
Section 14(a)(4) of FIFRA requires the Agency to "consider" the effect of the
penalty on the person's ability to continue in business when determining the amount of
the civil penalty.
EPA will generally not collect a total civil penalty which exceeds a violator's
ability to pay. There are three methods that EPA has chosen to determine a violator's
ability to pay, depending on the specifics of the case: (1) a detailed tax, accounting,
and financial analysis; (2) a guideline of four percent of average gross annual income;
or, (3) ABEL (a computer model).* The latter two are described below.
Four percent of gross sales. The average gross income (from all sources of revenue)
for the current year and the prior three years will be calculated. Even where the net
income is negative, four percent of gross income will be used as the "ability to continue
in business/ability to pay" guidance, since companies with a positive gross income will
be presumed to have sufficient cash flow to pay penalties even where there have been
net losses. For corporations, EPA will consider revenues from the total corporate
entity in its determination of ability to pay/ability to continue in business. Total
corporate entity refers to all sites owned and controlled by the foreign or domestic
parent company.
ABEL. ABEL is an EPA computer model that is designed to assess a for-profit
entity's ability to pay. The evaluation is based on the estimated strength of internally-
generated cash flows. The program uses standard financial ratios to evaluate a
violator's ability to borrow money and pay current and long-term operating expenses.
ABEL also projects the probable availability of future internally-generated cash flows to
evaluate some of a violator's options for paying a civil penalty. Because the program
only focuses on a violator's cash flow, there are other sources of revenue that should
also be considered to determine if a firm is unable to pay the full penalty. These
include:
o certificates of deposit, money market funds, or other liquid assets;
o reduction in business expenses such as advertising, entertainment, or
compensation of corporate officers; or,
o sale or mortgage of non-liquid assets such as company cars, aircraft, or land.
Other methods for determining a violator'* ability 10 pay may be provided in future guidance.
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It can be assumed that the respondent has the ability to pay at the time the
complaint is issued if information concerning the alleged violator's ability to pay is not
readily available. The respondent will be notified in the civil complaint of their right
under the statute to have their ability to continue in business considered in the
determination of the amount of the civil penalty. Any alleged violator can raise the
issue of ability to pay/ability to continue in business in their answer to the civil
complaint, or during the course of settlement negotiations.
If an alleged violator raises the inability to pay as a defense in their answer, or
in the course of settlement negotiations, the respondent should be asked to present
appropriate documentation, such as tax returns, financial statements, etc. Such records
are to be provided to the Agency at the respondent's expense and must conform to
generally recognized accounting principles and procedures. If the proposed penalty
exceeds the ability to pay guidance, the penalty may be reduced to a level consistent
with FIFRA section 14(a)(4).
There may be some cases where a respondent argues that it cannot afford to
pay the proposed civil penalty even though the penalty as adjusted does not exceed the
ability to pay guidance. In such cases, EPA may consider a delayed payment schedule
or a "Settlement with Conditions" agreement (see the "Settlement With Conditions"
section of this Enforcement Response Policy). In exceptional circumstances, EPA may
also consider further adjustment below the ability to pay guidance.
Finally, it is important that the regulated community not see the violation of
FIFRA as a way of aiding financially troubled businesses. Therefore, while EPA will
generally not collect a civil penalty which exceeds a violator's ability to pay, EPA
reserves the option, in appropriate circumstances, of seeking a penalty that might
exceed the ability to pay guidelines, cause bankruptcy, or result in a violator's inability
to continue in business. However, if the case is generated out of the EPA Regional
Offices, the case file must contain a written explanation, signed by the Regional
Program Division Director, which explains the reasons for exceeding the civiJ penalty
"ability to pay" guidelines. If the case is generated out of EPA Headquarters, the case
file must contain a written explanation signed by the Director of the Compliance
Division. Additionally, to ensure full and consistent consideration of penalties that may
cause bankruptcy or closure of a business, the Regions shall consult with the Office of
Compliance Monitoring and obtain concurrence before the decision is made to settle
the case or proceed to a hearing.
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For additional information on the consideration of a violator's ability to continue
in business, see the EPA General Enforcement Policy #GM-22, entitled "A Framework
for Statute-Specific Approaches to Penalty Assessments," issued on February 16, 1984
as part of the Agency's General Enforcement Policy Compendium.
Independently Assessable Charges '
A separate civil penalty, up to the statutory maximum, shall be assessed for each
independent violation of the Act. A violation is independent if it results from an act
(or failure to act) which is not the result of any other charge for which a civil penalty
is to be assessed, or if the elements of proof for the violations are different.
Dependent violations may be listed in the complaint, but will not result in separate civil
penalties.
Consistent with the above criteria, the Agency considers violations that occur
from each shipment of a product (by product registration number, not individual
containers), or each sale of a product, or each individual application of a product to be
independent offenses of FIFRA.* Each of these independent violations of FIFRA are
subject to civil penalties up to the statutory maximum of $5,000 for section 14(a)(l)
and $1,000 for section 14(a)(2). For example, when the EPA can document that a
registrant has distributed a misbranded product (one single EPA product registration
number) in four separate shipments (filling four orders), EPA will charge that registrant
with four counts of selling or distributing a misbranded product, and assess the
registrant civil penalties of up to $20,000. Similarly, when the EPA can document that
a registrant has shipped four separate misbranded products (four separate EPA
product registration numbers) in a single shipment, EPA will charge the registrant four
counts of selling or distributing a misbranded product, and assess civil penalties of up
to $20,000. A commercial applicator that misuses a restricted use product on three
occasions (either three distinct applications or three separate sites) will be charged with
three counts of misuse, and assessed civil penalties of up to $15,000. A dealer that
sells a restricted use pesticide (RUP) to six uncertified persons, other than in
accordance with FIFRA section 3(d), will be charged with six violations of FIFRA, and
assessed civil penalties of up to $30,000.
Independent violation* which can be documented a* both per safe and per shipment are to be calculated only a* either
per sale or per shipment, whichever is more appropriate based on the supporting documentation, and whichever approach
yield* the highest civil penally. For cample, it Person A ha* a violation invoMflf 1 sale and 2 shipments, and Person B
has a violation involving 2 sale* and 1 shipment, both persons would be charged for 2 violation* of FIFRA (Person A is
charged for 2 shipments and Person B is charged for 2 sales).
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On the other hand, a single event or action (or lack of action) which can be
considered as two" unlawful acts of FIFRA (section 12) cannot result in a civil penalty
greater than the statutory limit for one offense of FIFRA For instance, a person can
be assessed a civil penalty of up to $5,000 for selling and distributing a product in
violation of a cancellation order. However, while the Agency considers a cancelled
product to be no longer registered, that same person should not also be assessed an
additional civil penalty of up to $5,000 for sale and distribution of the same
unregistered product. In this example the violation of the cancellation order is
dependent on the sale and distribution of the unregistered/cancelled product.
Another example of a dependent violation is multiple misbranding on a single
product label. If a single product label is misbranded in one way or ten ways, as
defined by FIFRA section 2(q), it is still misbranding on a single product label and is
considered a single violation of FIFRA section 12(a)(l)(E). As a single violation of
FIFRA, the maximum civil penalty that may be assessed is $5,000. However, EPA may
assess a count of misbranding each time that a misbranded product is sold or
distributed. For example, a registrant who sells or distributes four distinct shipments of
a misbranded pesticide product may be assessed a civil penalty of up to $20,000.
Voluntary Disclosure .____
In order to encourage voluntary disclosure of FIFRA violations, the Agency will
offer a 40% reduction of the civil penalty if the disclosure was made: (1) by the
violator promptly to EPA, or States with cooperative enforcement agreements [within
30 to 60 days of discovery by the violator]; (2) before the violation was discovered by
EPA or a State; (3) before an inspection was scheduled by EPA or a State; and, (4)
the violator immediately takes all the steps necessary to come into compliance, and
steps requested by the Agency to mitigate the violation.
The reduction for voluntary disclosure may be made prior to issuing the civil
complaint. The civil complaint should state the original penalty and the reduced
penalty and the reason for the reduction.
Adjusting the Proposed Civil Penalty in Settlement :
Upon an answer to a civil complaint by the person charged (respondent), the
following circumstances may arise which may justify adjustment of the penalty proposed
in the civil complaint:
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Factual Changes
Recalculation of the proposed penalty is appropriate if the respondent can
demonstrate that the size of business category, culpability, or other facts used to derive
the gravity adjustment values from Appendix B are inaccurate. Adjustments to the
proposed civil penalty may also be appropriate if the respondent can demonstrate an
"inability to pay" the civil penalty (See "Ability to Continue in Business/Ability to Pay"
section of this policy). Where additional facts indicate to the Agency that the original
penalty is not appropriate, a new penalty shall be calculated consistent with the new
facts. The burden is on the respondent to raise those factors which may justify the
recalculation of the penalty.
Negotiations Involving Only the Amount of the Penalty
In some cases the respondent may admit to all jurisdictional and factual
allegations charged in the complaint and may desire a settlement conference limited to
the amount of the proposed penalty. In the absence of "special circumstances," (as
discussed in the "Special Circumstances" section of this ERP), a settlement conference
may be conducted to consider the amount of the proposed penalty.
Good Faith Adjustments ; ;
During the course of settlement negotiations, the EPA may consider the
respondent's attitude or good faith efforts to comply with FIFRA to reduce the penalty
as much as 20 percent below the proposed penalty, if such a reduction would serve the
public interest.
In no case is such a reduction mandated, and in no case should such a reduction
occur in the absence of an appropriate showing by the respondent and finding by the
Agency. Additionally, any reduction on account of the attitude or good faith efforts
does not have to extend to the full 20 percent reduction. Further, the total civil
penalty may not be reduced by more than 20 percent below the proposed penalty
without a showing of "special circumstances" as discussed below.
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Special Circumstances/Extraordinary Adjustments
Should a case arise in which EPA determines that there are no grounds for
adjustment of the proposed civil penalty based on new financial information or other
facts, or on a showing of inability to continue in business, and that equity would not be
served by adjusting the proposed penalty by only the allowable 20 percent good faith
attitude adjustment, the Regional Program Division Director may approve an
extraordinary adjustment to the proposed penalty for up to an additional 20%. This
adjustment is only appropriate in extraordinary circumstances and is not to be used
routinely. The EPA may also consider a delayed payment schedule or a "Settlement
With Conditions" agreement.
If a "special circumstances" reduction of the proposed civil penalty is granted,
the case file must include substantive reasons why the extraordinary reduction of the
civil penalty was appropriate, including: (1) setting forth the facts of the case; (2) why
the penalty provided from the FIFRA civil penalty matrices and gravity adjustment was
inequitable; (3) how all other methods for adjusting or revising the proposed penalty
would not adequately resolve the inequity; and, (4) the manner in which the extra-
ordinary adjustment of the penalty effectuated the purposes of the Act. The Regional
Program Division Director's written concurrence for the extraordinary reduction must
be incorporated into the case file. Additionally, a copy of the written justification for
the special circumstances reduction must accompany the consent agreement and final
order (CAFO), or consent agreement and consent order (CACO) which the Regions
send to the Office of Compliance Monitoring.
Settlement With Conditions CSWO
The Environmental Protection Agency (EPA) may choose to substitute part of a
civil penalty assessed for a violation of FIFRA for a specific environmentally beneficial
activity that would be performed by the Respondent. The Agency refers to the
settlement of a case under terms which commit the respondent to perform specified
acts in exchange for reduction of the penalty as "Settlement with Conditions (SWC)."
Under an SWC agreement, in exchange for a specified amount of the proposed
civil penalty, the violator agrees to take extensive and specific environmentally
beneficial activities, such as pollution prevention projects, risk communication,
remedying ground water hazards, clean-up operations, training, etc. These actions must
exceed those normally expected under the circumstances (actions in excess of those
required to correct the violation for which the violator was charged, and actions in
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excess of those already required by Federal/State/local laws), must be taken within a
specific time period, and will be strictly monitored by the Agency. It is the
responsibility of the Regional Program Office to monitor compliance with the SWC
agreement. Follow-up inspections should be conducted, as appropriate. If the Agencv
is not satisfied that the conditions of the agreement have been met at the end of the
term, the full amount of the penalty is due.
A minimum cash penalty should always be collected from the violator regardless
of the value pf the SWC activities. Further, steps must be taken to prevent a violator
from gaining an unwarranted tax advantage through income tax deductions of the cost
of the SWC activities. One method to do this is to calculate the net present after tax
value of the SWC activities (the Agency's BEN computer model may be used for this
purpose), and require that the violator pay a minimum cash penalty equal to that sum
of money, in addition to the SWC activities.
Settlements with Conditions should be employed with restraint. The SWCs
should not be used in a manner which encourages people to violate FEFRA unti] they
are discovered and then offer to correct actions in hope of a penalty reduction.
Further, a violator is not presumed to be entitled to an SWC and such relief is granted
at the discretion of the Agency.
Criteria for Choosing an SWC
An SWC should be considered in the following circumstances:
o Violations have been documented which warrant a civil penalty; and,
o The violations do not evidence wanton, knowing, or willful disregard for
regulatory requirements; and,
o The violator has exhibited a good-faith attitude toward solving the
noncompliance and has no history of non-compliance; and,
o There are clear public benefits to use of an SWC; and
o An SWC acceptable to EPA can be negotiated.
An SWC should also be considered where the total proposed civil penalty
exceeds the ability to pay guidance, or when nonprofit entities are found to be in
violation of FIFRA.
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Responses to Noncompliance with the SWC
Penalty Payment
If the respondent fails to adhere to the conditions of the SWC, the uncollected
penalty, or the L..collected portion of the penalty is due and payable within 60 days
from the date the conditions of the SWC were to be met. If the respondent refuses to
pay, the Agency may refer the action to the Department of Justice which may bring a
recovery action.
Reinspection and Additional Enforcement Action
Once the EPA determines that the conditions of the SWC have not been
fulfilled and so notifies the respondent, the EPA should reinspect the facility to
document any additional violations. When considering additional enforcement actions
in response to any violations discovered upon reinspection, the Agency may give
consideration to pursuing injunctive action. Clearly, in cases of serious violations where
administrative enforcement action cannot be expected to achieve compliance, an
injunction may be a desirable enforcement response.
Elements of an SWC
The Agency is examining the procedures for issuing SWC agreements and the
necessary contents of those agreements. When final guidance is available, we will
incorporate these guidelines into the FIFRA ERP. In the interim, the procedures
provided below should be followed:
An SWC, like any FIFRA settlement, consists of: (1) a complaint and (2) a
consent agreement and final order (CAFO), or consent agreement and consent order
(CACO). It also includes: (5) a Penalty Mitigation Agreement and (4) a Penalty
Mitigation Order.
A civil complaint alleging violations of FIFRA and proposing a civil penalty must
be issued to establish the Agency's allegations that violations have occurred and to
initiate any SWC negotiations. The complaint should be issued in the same format as
in any FIFRA administrative civil penalty action.
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The CAFO/CACO assesses a total civil penalty and disposes of the
administrative "proceeding. In the CAFO/CACO, the respondent (1) admits the
jurisdictional allegations of the complaint, (2) admits the facts stipulated in the consent
agreement or neither admits nor denies specific factual allegations, (3) consents to the
assessment of a stated administrative civil penalty, and (4) waives its right to- a hearing
and consents to the issuance of a final order which requires a payment of a civil
penalty.
The Penalty Mitigation Agreement sets forth the Compliance Program and
Schedule (CPS). Under this agreement and CPS, the respondent agrees to perform
specific remedial actions by specific dates. If the respondent successfully meets the
conditions of the penalty mitigation agreement, the EPA will not collect a specified
portion of the civil penalty.
The Penalty Mitigation Order formally mitigates a portion of the penalty and is
executed when the Agency is satisfied that the respondent has met the conditions
outlined in the CPS. If the respondent has not satisfied the conditions, the order
informs him that the payment of the previously assessed penalty is due.
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APPENDIX A
FIFRA CHARGES AND GRAVITY LEVELS
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A-l
FIFRA CHARGES AND GRAVITY LEVELS
FIFRA FTTS
SECTION CODE VIOLATION LEVEL
1AA Sold or distributed a pesticide NOT REGISTERED 2
under section 3 or was CANCELLED or SUSPENDED,
which was not authorized by the Administrator.
1AB Registrant, wholesaler, dealer, retailer, or other 2
distributor ADVERTISED or otherwise "offered for
sale," in any medium, a pesticide that was NOT
REGISTERED under section 3 or was CANCELLED
or SUSPENDED, other than in accordance with
Agency policy.
1BA CLAIMS made for a pesticide as part of sale or 2
distribution differed substantially from those
accepted in connection with registration.
IBB Registrant, wholesaler, dealer, retailer, or other 2
distributor ADVERTISED, or otherwise "offered for
for sale" in any medium, a REGISTERED PESTICIDE
product for an UNREGISTERED USE, other than in
accordance with Agency policy.
1CA Sold or distributed a pesticide whose COMPOSITION 2
DIFFERED from the composition represented in the
registration.
IDA Sold or distributed a pesticide which has not 2
been COLORED or DISCOLORED pursuant to
section 25(c)(5).
1EA Sold or distributed a pesticide or device which is 2
MISBRANDED in that the label has a statement, design,
r or graphic representation which is false or misleading.
1EB Sold or distributed a pesticide or device which is 2
MISBRANDED in that the pesticide is not contained
in a package or other container or wrapping which
conforms to the standards established pursuant to
section 25(c)(3) (e.g., not contained in child-
resistant packaging or safety containers).
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A-2
FIFRA
SECTION
FITS
CODE
FIFRA CHARGES AND GRAVITY LEVELS
VIOLATION
LEVEL
2(q)(2)(A)
2(q)(2)(B)
1EC Sold or distributed a pesticide or device which is
MISBRANDED in that it is an imitation of, or is
offered for sale under the name of, another pesticide.
1ED Sold or distributed a pesticide or device which is
MISBRANDED in that the label did not bear the
registration number assigned under section 7.
1EE Sold or distributed a pesticide or device which is
MISBRANDED in that any words, statements, or other
information required by the Act were not prominently
placed on the label in such a way as to make it
readable or understandable.
1EF Sold or distributed a pesticide or device which is
MISBRANDED in that the label did not contain directions
for use necessary to make the product effective and to
adequately protect health and the environment
1EG Sold or distributed a pesticide or device which is
MISBRANDED in that the label did not contain a warning
or caution statement adequate to protect health and
the environment.
1EH Sold or distributed a non-registered pesticide
intended for export which is MISBRANDED in that the
label did not have a prominently displayed, "Not
Registered for Use in the United States of America."
1EI Sold or distributed a pesticide which is MISBRANDED
in that the label did not bear an ingredient statement
on the immediate container which is presented or
displayed under customary conditions-of purchase.
1EJ Sold or distributed a pesticide which is MISBRANDED
in that the labeling does not contain a statement
of the use classification for which the product was
registered.
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A-3
FIFRA
SECTION
FTTS
CODE
FIFRA CHARGES AND GRAVITY LEVELS
VIOLATION
LEVEL
2(q)(2)(C)
2(q)(2)(D)
- (3)
12(a)(2)(A)
1EK Sold or distributed a pesticide which is MISBRANDED
in that there is not a label affixed to the pesticide
container, and to the outside wrapper of the retail
package if the required information on the immediate
container cannot be clearly read, a label bearing all
of the following information: (i) the name and address
of the producer, registrant, or person for whom
produced; (ii) the name, brand, or trademark under
which the pesticide is sold; (iii) the net weight
or measure of the content; and, when required by
regulation, (iv) the registration number assigned to
the pesticide and the use classification.
1EL Sold or distributed a pesticide which is MISBRANDED
in that the pesticide is sold in quantities highly
toxic to man and the label failed to bear a skull and
crossbones, and the word "poison" prominently in red
on a contrasting background color, and/or the label did
not bear a statement of practical treatment.
1EM Sold or distributed a pesticide which is ADULTERATED
in that: (i) the strength or purity falls below the
professed standard of quality expressed on the
labeling; (2) any substance has been substituted
wholly or in part abstracted; or, (3) any valuable
constituent of the pesticide has been wholly or in
part abstracted.
2AA Person DETACHED, ALTERED, DEFACED,
or DESTROYED, in whole or in part, any LABELING
required under the Act
»
2BA Person refused to PREPARE, MAINTAIN, or SUBMIT
any RECORDS required under sections 5, 7, 8, 11,
or 19.
2BB Person refused to SUBMIT any REPORTS required by or
under section 5, 6, 7, 8, 11 or 19.
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A-4
FIFRA
SECTION
FITS
CODE
FIFRA CHARGES AND GRAVITY LEVELS
VIOLATION
LEVEL
12(a)(2)(C)
12(a)(2)(D)
12(a)(2)(E)
12(a)(2)(F)
12(a)(2)(F)
12(a)(2)(G)
12(a)(2)(H)
2BC A registrant refused to submit REPORTS under
section 6(a)(2) regarding UNREASONABLE ADVERSE
EFFECTS of their pesticide.
2BD Person refused to allow entry, INSPECTION, copying of
records, or sampling authorized by this Act.
2CA Person gave a GUARANTY or undertaking provided for in
section 12(b) which was FALSE in any particular.
2DA Person used to their personal advantage or revealed
to persons other than those authorized by the Act any
INFORMATION acquired under the Act which is
CONFIDENTIAL.
2EA Registrant, wholesaler, dealer, retailer, or other
distributor ADVERTISED a RESTRICTED USE
PESTICIDE without indicating that the product was
restricted.
2FA Person DISTRIBUTED, SOLD, MADE AVAILABLE
FOR USE, or USED a RESTRICTED USE PESTICIDE
for a purpose other than in accordance with section 3(d)
or regulations issued.
2FB Person distributed, sold, or made available for use,
or used, a RESTRICTED USE PESTICIDE without
maintaining the RECORDS required by regulations
(A Notice of Warning should be issued for first-time
"partial" violations. Violations continuing subsequent
to the issuance of a civil complaint are to result in
a suspension see "Denials, Suspensions, Modifications,
or Revocations of Applicator Certifications" section
of this ERP).
2GA Person USED a registered pesticide in a manner
inconsistent with its labeling.
2HA Person USED a pesticide which was under an
EXPERIMENTAL USE PERMIT contrary to the
provisions of the permit
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A-5
FIFRA
SECTION
FTTS
CODE
FIFRA CHARGES AND GRAVITY LEVELS
VIOLATION
LEVEL
12(a)(2)(J)
12(a)(2)(J)
12(a)(2)(K)
12(a)(2)(K)
12(a)(2)(K)
12(a)(2)(K)
12(a)(2)(K)
12(a)(2)(L)
7(a)
12(a)(2)(L)
2IA Person violated any order issued under section 13
(e.g., STOP SALE, USE OR REMOVAL ORDER
or SEIZURE).
2JA Person violated any SUSPENSION ORDER issued under
section 6.
2JB Person violated any SUSPENSION ORDER issued under
section 3(c)(2)(B) or 4.
2KA Person violated any CANCELLATION ORDER issued
under the Act on the grounds of UNREASONABLE
ADVERSE EFFECTS.
2KB Person violated any CANCELLATION ORDER issued
under the Act on grounds OTHER THAN
UNREASONABLE ADVERSE EFFECTS.
2KC Person failed to submit a SECTION 6(g) NOTICE when
required.
2KD Person submitted a NOTABLY LATE SECTION 6(g)
NOTICE
2KE Person submitted an INCOMPLETE or INCORRECT
SECTION 6(g) NOTICE
2LA PRODUCED a pesticide or active ingredient subject to
the Act in an UNREGISTERED ESTABLISHMENT.
2LB Producer FAILED TO SUBMIT, or submitted
NOTABLY LATE a REPORT to the Administrator,
under SECTION 7, which indicates the types
and amounts of pesticides or active ingredients
which they are currently producing, which they
produced during the past year, and which they
sold or distributed during the past year.
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A-6
FIFRA
SECTION
FTTS
CODE
FIFRA CHARGES AND GRAVITY LEVELS
VIOLATION
LEVEL
12(a)(2)(L)
12(a)(2)(L)
12(a)(2)(L)
12(a)(2)(L)
12(a)(2)(M)
12(a)(2)(N)
2LC Producer submitted a LATE REPORT to the Administrator.
under SECTION 7, which indicates the types and amounts
of pesticides or active ingredients which they are
currently producing, which they produced during the
past year, and which they sold or distributed during
the past year (civil complaint issued only if the
producer does not respond to a Notice of Warning or
there is a subsequent violation within a three year
timeframe from the first violation).
2LD Producer submitted an INCOMPLETE SECTION 7
REPORT with MINOR OMISSIONS of the
required information (civil complaint issued only
if the producer does not respond to a Notice
of Warning or there is a subsequent violation
within a three year timeframe from the first
violation).
2LE Producer submitted an INCOMPLETE or a FALSE
SECTION 7 REPORT with MAJOR OMISSIONS
or ERRORS of the required information.
2LF Upon request of the Administrator for the purposes
of the issuance of section 13 Stop Sale Orders, a
PRODUCER FAILED TO PROVIDE the names and
addresses of the recipients of the pesticides
produced in any of his registered establishments.
2MA Person KNOWINGLY FALSIFIED all or any part of an
application for registration, application for an
experimental use permit, any information submitted
under section 7, any records required to be maintained
by the Act, any report filed under the Act, or any
information marked as confidential and submitted to
the Administrator under anv provision of the Act.
2NA A registrant, wholesaler, dealer, retailer, or other
distributor FAILED TO FILE REPORTS required
by the Act
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A-7
FIFRA
SECTION
FTTS
CODE
FIFRA CHARGES AND GRAVITY LEVELS
VIOLATION
LEVEL
12(a)(2)(0)
12(a)(2)(P)
12(a)(2)(Q)
12(a)(2)(Q)
12(a)(2)(Q)
12(a)(2)(Q)
12(a)(2)(Q)
12(a)(2)(R)
12(a)(2)(S)
12(a)(2)(S)
2OA Person ADDED A SUBSTANCE TO, or TOOK
a substance from a pesticide in a manner that may
defeat the purpose of this Act.
2PA Person USED a pesticide in TESTS ON HUMAN BEINGS
in violation of the conditions specified by the Act.
2QA Person FALSIFIED INFORMATION RELATING to
the TESTING of any pesticide (or any of its ingredients,
metabolites, or degradation products) for which the
person knows will be furnished to the Administrator,
or will become a part of any records required to be
maintained by this Act.
2QB Person falsely represented compliance with the FIFRA
Good Laboratory Practice (GLP) regulations as a result
of a HIGH LEVEL GLP violation.
2QC Person falsely represented compliance with the FIFRA
Good Laboratory Practice (GLP) regulations as a result
of a MIDDLE LEVEL GLP violation.
2QD 14(a)(l) person falsely represented compliarce with
the FIFRA Good Laboratory Practice (GLP) regulations
as a result of a LOW LEVEL GLP violation.
2QE 14(a)(2) person falsely represented compliance with
the FIFRA Good Laboratory Practice (GLP) regulations
as a result of a LOW LEVEL GLP violation.
2RA Person submitted DATA KNOWN TO BE FALSE in
support of a registration.
2SA Person sold, distributed, or used an UNREGISTERED
pesticide in violation of a REGULATION ISSUED UNDER
SECTION 3(a).
2SB Person violated any REGULATION ISSUED UNDER
SECTION 19.
* Gravity levels for these violation! will be assigned in subsequent ERPs.
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APPENDIX B
GRAVITY ADJUSTMENT CRITERIA
-------
B-l
APPENDIX B
GRAVITY ADJUSTMENT CRITERIA
VIOLATION
GRAVITY OF HARM
Pesticide
Harm to Human
Health
Environmental
Harm
VALUE
2
'
1
5
3
3
1
5
3
3
1
CIRCUMSTANCES
1
Toxicity - Category I pesticides.
Signal Word "Danger", restricted
use pesticides (RUPs), pesticides
with flammable or explosive
characteristics (i.e., signal
words "Extremely Flammable" or
"Flammable"), or pesticides that
are associated with chronic health
effects (mutagenicity, oncogenicity, .
teratogenicity, etc.).
'
Toxicity -. Categories II through
IV, signal word "Warning" and
"Caution," no known chronic effects.
.
Actual serious or widespread2 harm
to human health.
'
Potential serious or widespread2
harm to human health.
.
Harm to human health is unknown.
Minor7 potential or actual harm to
human health, neither serious nor
widespread.
Actual seno'iis or widespread2
harm to ihe euvuomnwiii (e.g.,
crops, water, livestock, wildlife,
wilderness^ or other sensitive
natural areas).
Potential serious or widespread2
harm to the environment
Harm to the environment is unknown.
Minor* potential or actual harm to
the environment, neither widespread
nor substantial.
1
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B-2
VIOLATION
GRAVITY OF
MISCONDUCT
Compliance''
History
Culpability5
VALUE
5
4
2
0
4
2
2
0
CIRCUMSTANCES
1
If a violator is a 14(a)(l) person
with more than one prior violation
of FIFRA and at least one prior
violation was a level 1 violation.
If a violator is a 14(a)(2) person
with more than two prior FIFRA
violations, and at least one prior
violation was a level 1 violation.
If a violator is a 14(a)(l) person
with more than one prior violation
of FIFRA, and no prior level 1
violations. If a violator is a
14(a)(2) person with more than
two prior FIFRA violations, and
no prior level 1 violations.
If a 14(a)(l) person, one prior
violation of FIFRA If a 14(a)(2)
person, two prior FIFRA violations.
No prior FIFRA violations.
.
Knowing or willful violation of the
statute. Knowledge of the general
hazardousness of the action.
Culpability unknown.
Violation resulting from negligence.
Violation was neither knowing nor j
willful and did not result from j
negligence. Violator instituted
steps to correct the violation |
immediately after discovery of j
the violation. j
1
1
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B-3
APPENDIX B FOOTNOTES
' The graviry adjustment criteria in Appendix B should not be used for recordkeeping and reporting violations. Therefore, first-time civii
penalties for recordkeeping or reporting violations should be.assessed at the matrix value, while subsequent penalties should be
increased by an increment of 30% (up to the statutory maximum).
- For the purposes of this ERP. serious or widespread harm refers to actual or potential harm which does not meet the parameters of
minor harm, as described below.
* For the purposes of this ERP. minor harm refers to actual or potential harm which is. or would be of short duration, no lasting ei.'ecis
or permanent damage, effects are easily reversible, and harm does not, or would not result in significant monetary loss.
4 The following considerations apply when evaluating compliance history for ihe purposes of Appendix B:
(a) In order to constitute a prior violation, (he prior violation must have resulted in: (1) a final order, either as a result of an
uncontested complaint, or as a result of a contested complaint which a finally resolved against the violator (2) a consent
order, resolving a contested or uncontested complaint by the execution of z consent agreement; (3) the payment of a civil
penalty by the alleged violator in response to the complaint, whether or not the violator admits to the allegations of the
complaint; or (4) conviction under the FIFRA's criminal provisions.
A notice of warning (NOW) will not
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APPENDIX C
SUMMARY OF TABLES
-------
C-l
SUMMARY OF TABLES
TABLE 1
FIFRA CIVIL PENALTY MATRICES
FFRA SECTION
SIZE Of BUSINESS
LEVEL
level 1
level 2
level 3
level 4
|
t
5,000
5,000
4,000
3,000
[I
5,000
4,000
3,000
2,000
III
5,000
3.000
2,000
1,000
1
FTFRA SECTION
SIZE OF BUSINESS
LEVEL
I '
II
III
level 1
level 2
level 3
1,000
1,000
800
1,000
800
600
1,000
600
500
i
* This matrix'is onfy for >ae in determining civil penalties
issued subsequent to a notice of warning or in the case of
a "for hire applicator", subsequent to the issuance of a civil
penalty of
TABLE 2
SIZE OF BUSINESS CATEGORIES
Section
violators:
Section 14teVaV21 violators:
I
n
in
over $1,000,000
$300,001 - $1,000,000
SO - $300,000
I
n
ra
. over $200,000
$50,001 - $200,000
$0 - $50,000
TABLE 3
GRAVTIT ADJUSTMENT CRITERIA
Total Gravity Value*
Enforcement Remedy
3 or below
4
5
6
7
8 to 12
13
14
15
16
17 or above
No action. Notice of Warning, or
50% reduction of matrix value.
Reduce matrix value 40%
Reduce mautc value 30%
Reduce matrix value 20%
Reduce matrix value 10%
Attest matrix value
Increase matrix value 10%***
Increase matrix value 15%***
Increase matrix value 20%***
Increase matrix value 25%***
Increase matrix value 30%***
Use Appendix B to determine Gravity Values.
50% reduction of matrix value is recommended where multiple count violations
Matrix value can onfy be increases' to ibt sssstsssry maztmsmt.
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APPENDIX D
FIFRA CIVIL PENALTY CALCULATION
WORKSHEET
-------
D-l
F1FRA CIVIL PENALTY CALCULATION WORKSHEET
RESPONDENT
ADDRESS
DOCKET NO.
DATE
Appendix A
1. Statutory Violation
2. FTIS Code
3. Violation Level
Table 2
4. Violator Category -
§14 (a) (1) or §14 (a) (2)
5. Size of Business Category
Table 1
6. Base Penalty
ADoendixB
7. Gravity Adjustments:
a. Pesticide Toxicity
b. Human Harm
c. Environmental Harm
d. Conpliance History
e. Culpability
f . Total Gravity
Adjustment Value
(add items 7a - 7e)
Tabla 3
g. Percent Adjustment
h. Dollar Adjustment
8. Final Penalty*
(item 7h from item 6)
>~*_uiu jj KSJ iwCcuL xnericL-Lty
(total of all Columns
frvf 1 i n^ Q aVvit>A\
PREPARED I
count 1
i"
*S**~~
'r"* ,
" &
»
,^ - f
V \
JV
count 2
-
, ' '
-,.. ' ,,$.',' '#
%w
f
i"5*;|ll 1 -FT-5*'
.' ^ ^ ' 3Sftv% ^
-.
count 3
.
vX *.\s / ^* ^
* ^
> /
. /
> , -.
^
1 .
ag^"*"*- ' ta
" t '
_t.t:j *. T-JV^ s v -"
'
count 4
1
'
v.x
s
i
* i
. 1
NOTE: The final penalty in e»ch column of line 8 cannot qctcd (be statutory manmum.
-------
D-2
FIFRA CIVIL PENALTY CALCULATION WORKSHEET (cont)
count
count
count
count
1. Statutory Violation
2. FTIS Code
3. Violation Level
Table 2
4. Violator Category -
§14(a)(1) or §14(a)(2)
5. Size of Business Category
Table 1
6. Base Penalty
7. Gravity Adjustments:
a. Pesticide Toxicity
b. Human Harm
c. Environmental Harm
d. Corpliance History
e. Culpability
f. Total Gravity
Adjustment Value
(add itens 7a - 7e)
Table 3
g. Percent Adjustment
h. Dollar Adjustment
8. Final Penalty*
(item 7h from item 6)
PAGE
OF
* NOTE: The final penalty in each column of line 8 cannot exceed the statutory maximum.
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