United State* •        Pesttodesand  .
Environmental Protection    Toxic Substances,
              Enforcement D*v»ton    20460
Ffederal Insecticide,
and Rodenticide Act
Corfipliance/Enforcemerit
Guidance Manual
Pdlicy Compendium
Volume 4:   FIFRA Enforcement
Response Policies

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 Table of Contents
Volume 4 of the FIFRA Compliance Enforcement Guidance Manual Policy Compendium contains the
Enforcement Response Policies issued by the Office of Compliance Monitoring that are currently in
effect.  The Table of Contents of the remaining volumes, FIFRA miscellaneous sources, and a list of
obsolete documents are contained in the Appendices.

Any questions or comments concerning these documents should be addressed to:

       Director, Policy and Grants Division
       Office of Compliance Monitoring (EN-342)
       Office of Pesticides and Toxic Substances
       U.S. Environmental Protection Agency
       401 M Street, S.W.
       Washington, D.C. 20460
                         Volume 4: Enforcement Response Policies'
                TITLE                                                           DATE

Memorandum:  Status of a State or County Government Agency                          02/24/81
Section 14(a)(2) of FIFRA

Enforcement Response Policy for FIFRA Section 7(c)                                   02/10/86
Pesticide Producing Establishment Reporting
Requirement

Enforcement Response Policy for the Federal Insecticide,                                07/02/90
Fungicide and Rodenticide Act (FIFRA ERP)
    'Note: These documents may also be found in Appendix 6 of the FIFRA Compliance/Enforcement
Guidance Manual.

FIFRA Compliance/Enforcement                                          Guidance Manual
Policy Compendium                         i                             September 1992

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/*4±\        UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                WASHINGTON. D.C.  20460

                                     FEB 24  1981
                                                               OFFICE OF ENFORCEMENT
      MEMORANDUM

      SUBJECT:  Status of a  State or County Government Agency under Section
      :          14(a)(2)  of  FIFRA                \
      TO:       Regional  Enforcement Division Directors
                Pasticide Branch Chie-fs
           Enclosed for your reference is a memorandum prepared by the Legal
      Section of the Pesticides and Toxic Substances Enforcement Division in
                                                             •
      response to a question by Region VII concerning the treatment of state
      or county government pesticide applicators under the FIFRA civil penalty
      section.  The conclusion this memorandum reaches is that under Section
      14(a)(2) of FIFRA,  state or county government applicators should be
      treated in the same w^y as private applicators.
                                             A. E. Conroyil, Director
                                          Pesticides and ToxicjSubstances
                                                Enforcement Division
      Enclosure

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          UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                           WASHINGTON. D.C.  20460
                                   I 0  1981
                                                          OFFICE OF ENFORCEMEN1
MEMORANDUM

SUBJECT:  Status of a State or County Government Agency  under Section 14(a)(2)
          of FIFRA

FROM:     Ruthanne MWer, Legal  Intern
          Legal Section

TO:       John Ulfelder, Head
          Legal Section


Introduction

     Section 14(a) of FIFRA establishes civil  penalties  for  different classes
of offenders as follows:

     (a)  C1v11 Penalties -

          (1)  In General - Any registrant,  contmerdal applicator,
               wholesaler, dealer,  retailer, or other distributor who
               violates any provision of this Act may be assessed a
               civil  penalty by the Administrator of not more than
               $5,000 for each offense.
                   »

          (2)  Private Applicator - Any private applicator or other
               person not included  1n paragraph (1)  who  violates any
               provision of this  Act subsequent to receiving a written
               warning from the Administrator or following a citation
               for a  prior violation may be  assessed a civil penalty
               by the Administrator of not more than $1,000  for each
               offense: Provided, that any applicator not Included
               under  paragraph U)  of this subsection who holds or
               applies registered pesticides,  only to provide a service
               of controlling pests without  delivering any unapplied
               pesticide to any person so served, and who violates any
               provision of this  Act may be  assessed a civil penalty by
               the Administrator  of not more than $500 for the first
               offense nor more than $1,000  for each subsequent offense.

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                                      -2-
 The  problem this memorandum addresses 1s whether a state or local government
 agency which applies other than restricted use pesticides Is considered under
 section 14(a)(2) as "any private applicator or other person not Included 1n
 paragraph (1)" and thus subject to a written warning for a first offense, or
 considered as "any applicator not Included under paragraph (1) of this sub-
 section who holds or applies registered pesticides, or use dilutions of reg-
 istered pesticides, only to provide a service of controlling pests without
 delivering any unapplied pesticide to any person so served" and thus subject
 to a penalty of not more than $500 for the first offense.

     While the statutory language of the latter category on its face appears
 to Include a state or local government agency applying non-restricted use
 pesticides - as an applicator who applies the registered pesticide "only to
 provide a service of controlling pests without delivering any unapplied pes-
 ticide to any person so served"-, the legislative history of this section
 indicates that Congress did not intend to include a state or county agency
 in this category.  Therefore, such an agency should only be subject to a
 written warning for a first offense.

 Discussion

     In the section-by-section analysis of FIFRA by the U.S. Senate the
 classification of offenders in section 14 1s explained as follows:

     (1)  Registrants, wholesalers, commercial  applicators, dealers,
          retailers and other distributors who violate FIFRA may be
          assessed civil penalties of not to exceed $5,000 for each
          offense.

     (2)  Private applicators and other persons not specifically in-
          cluded abov.e who violate FIFRA will  receive a written warning
          for their first offense, but may be assessed a civil  penalty
          of not to exceed $1,000 for subsequent offenses.

    (3)   Applicators not included 1n (1)  above who are in the business
          of applying registered pesticides for hire - but who do not
          deliver any unapplied pesticide to any person served - may be
          assessed civil penalties of not to exceed $500 for the first
          offense and $1,000 for each subsequent offense.  This class of
          offender will include persons who apply general use pestlcldeT
          for hire, but not persons who apply  restricted use pesticides
          for hire - who are considered to be  "commercial applicators"
          under section 2(e).

(emphasis added)   SENATE COMM.  ON AGRICULTURE,  NUTRITION, AND FORESTRY,  95TH,
CONG.,  2D SESS.,  FEDERAL PESTICIDE ACT OF  1978  (Comm.  Print 1979)  at 162-63.
     In the section-by-section  analysis of the  Federal  Pesticide Act of 1978,
the third classification is described in a similar  way by the Senate Agri-
culture Committee:

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                                   -3-

          Thls amendment establishes a third class rf violators  and
          penalties as follows:   Applicators for hire who  are  neither
          commercial  applicators I that Is,  they apply only general use
          pesticides) nor distributors (that 1s, they do not deliver
          unapplied pesticides to the persons so served)....

(emphasis added) Id.  at 78.

     In order for a state or county government agency to fall  In'the third
category and be subject to a fine for a first offense, the agency or Us
employees would, thus, have to be considered "applicators  1n the'buslness
of applying registered pesticides for hire"  or "applicators for  hire."

     The legislative history of the Federal  Pesticides Act of  1978 Indicates.
however, that the phrase "applicator for hire" was directed at the pest con-
trol Industry.  Prior to the 1978 amendments, pest control  operators were
treated 1n the same way as "sellers" and "distributors."   The  former section
14 penalty provision had only two categories of offenders  as follows:

     (a)  C1v1l Penalties

          (1)  In General. - Any registrant, commercial applicator,
               wholesaler, dealer, retailer, or other distributor who
               violates any provision of this Act may be assessed a civil,
               penalty by the Administrator  of not more than $5,000 for
               each offense.

          (2)  Private ApplIcator. - Any private applicator or other person
               not included m paragraph (l) who violates  any  provision
               of this Act subsequent to receiving a written warning from
               the Administrator or following a citation for a  prior vio-
               lation may be assessed a civil penalty by the Administrator
               of not more than $1,000 for each offense.

In 1977 the National  Pest Control Association lobbied heavily  for a statutory
distinction between "users" of pesticides and "sellers and distributors" of
pesticides 1n the amended version of FIFRA.   On June 8, 1977,  Or. Phillip J.
Spear, acting executive director of the National Pest Control  Association,
testified before the Senate Subcommittee on  Agricultural Research and General
Legislation 1n favor of an amendment "to distinguish use from  distribution
and sale," stating that "[the NCPA] strenuously object[s]  to EPA's Interpre-'
tatlon that a pest control operator who supplies the pesticides  which he
applies commercially 1s not only selling a  service - the application - but 1s
also distributing a product - the pesticides."   123 CONG. REC.  25707 (1977).
That the lobbying efforts were sucessful 1s  evidenced by the Committee of
Conference's adoption of a modified House amendment distinguishing commercial
pest control applicators from sellers and distributors. Section 2(e)(l) was
amended to provide that "Ca]ny applicator who holds or applies registered
pesticides, or use dilutions of registered  pesticides consistent with section

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                                    -4-

 2(ee)  of this  Act, only  to provide  a  service of controlling pests without
 delivering any unapplied pesticide  to any person  so  served is not deemed to
 be a seller or distributor of pesticides under this  Act."

      The Senate had  responded by amending FIFRA to establish "professional
 applicators" as a separate class of persons.  This amendment, which was
 not adopted, is explained in the Joint Explanatory Statement of the Commit-
 tee of Conference as follows:

           29.   Professional or Commercial Applicators

                A.  The Senate bill  amends FIFRA to establish "pro-
           fessional  applicators" as a class of persons separate
           from "sellers" and "distributors."  (Professional appli-
           cators are now considered as sellers or distributors for
           the  purposes of enforcing FIFRA.)  Specifically, the
           Senate bill adds to section 2 of FIFRA a definition of
           "professional  applicator" to mean an applicator who
           applies pesticide for hire; and amends other sections
           ot KIFRA to make professional applicators  subject to
           the  unlawful acts provisions, the stop sale, use, or
           removal order  provisions, and the criminal and civil
           penalties  In FIFRA.

 (emphasis added) SENATE  COMM. ON AGRICULTURE, NUTRITION, AND FORESTRY,
 95th CONG.  20  SESS., FEDERAL PESTICIDE ACT OF 1978 (Comm. Print 1979) at 29.
 Although the Senate  bill provided the distinction In definition, 1t also pro-
 vided  that this  class of "professional applicators" be subject to the same
 strict penalty and inspection provisions as sellers and distributors.  The
 language of this Senate  amendment shows the origin of the phrase "applicator
 for hire" and  shows  that this phrase  was directed at those persons In the
 pest control industry.

     The amendment which was agreed to In conference established a separate
 category for this group  of offenders, instead of Incorporating them with
 sellers  and distributors.  The Committee of Conference explained the adopted
 category as follows:

           The  conference substitute amends the civil  penalties in
           section !4(bH2) [sic].   If there Is a violation by a
           person who commercially applies a pesticide registered
           for  general use, or use dilution of such pesticide, a
           civil  penalty of up to $500 may be imposed for the first
           offense and up to II,000  for each subsequent offense.
                           I/
 (emphasis added) JUJ. at 30."  The use of the word "commercially" in this
 explanation supports the Interpretation that this category of offenders
I/ It appears that there Is a misprint here.  The reference should be to
T)4(£)(2) - the civil penalty provision, not to §14(b>)(2) - the criminal
penalty provision.

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                                      -5-

 Includes only appltcators In the pesticide control Industry, and not local
 or  county government agencies.

      In addition to the legislative history of section 14(a)(2), case law
 Interpreting the phrase "for hire" as used 1n other statutes has determined
 that  public officers and public employees who work for a set salary may  not
 be  considered "for hire."
                                                               •

      In the case of People v. Sturgis. 79 N.Y.S. 969, 78 App. 01v.  460 (Sup,
 Ct. 1903) the New York Supreme Court determined that a city fireman was
 not Included 1n a labor law which defined the term employee as "a mechanic,
 worklngman or laborer who works for another for hire." (emphasis added)  Id.
 at  969.  The court stated its rationale as follows:

          It Is obvious that the legislature did not intend to
          Include the uniformed members of the fire department
          within the act, when, In the second section, it limited
          its application to a mechanic, worklngman, or laborer
          "who works for another for hire."  The word "hire"
          evidently does not relate to public officers or others
          holding positions under the city, who are Included 1n
          the classified lists of the civil service law, such as
          the uniformed members of the fire department who are
          appointed to a position after rigid examination, and free
          from competitive lists.  No contract of hiring is made
          with them.  They receive annual salaries, not wages,
          either in the common or legal acceptation of the term....
          Under other sections, they are graded in rank, receive
          salaries according to such rank, and become entitled to
          pensions under certain conditions.  These rights and
          privileges clearly differentiate them, from laborers
          working for hire.

Jd. at 970-71.

      In the later case of Aleksich v. Industrial  Accident Fund. 151  P. 2d.
 1016 (Mont. 1944), the Supreme Court of Montana,  In jdetermlnlng whether  a
 policeman was afforded protection under the Workmen's Compensation  Act,
 interpreted in a similar way the word "hire" as used in a section defining
 "employee" or "workman" as "every person in this state... who is In the
 service of an employer... under any appointment or contract of hire,  ex-
 pressed or Implied, oral  or written...."  Id. at 1018.   The court quoted
 the Webster's New International Oict1onary~₯ef1n1tion of "hire" as  meaning
 "'to engage or purchase labor or services of (anyone) for compensation or
wages; as, to hire a servant, an agent or an advocate.1"  I_d_.   The  court
 stated as follows:

          The word "hire" denotes the relationship of master and
          'servant arising out of a contract, expressed or itnpled,
          and we must assume that the legislature used the word
          1n Us ordinary meaning.  Officers are not servants.

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                                      -6-

          They are neither hired nor discharged at the will  of
          anyone.  Their compensation is a salary fixed by  law
          and can be increased or decreased only by legislative
          enactment....   Unless the statute specifically includes
          public officers 1t 1s generally held under statutes bind-
          ing the application to employees under an appointment or
          contract of hire, a public officer is not included.
Id
     Since case law has determined that public  officers and public employees
may not generally be considered "for hire"  and  since  the legislative history
of FIFRA section 14(a)(2)  specifically shows  that this phrase was directed at
the pest control industry, a state or local government agency which applies
an other than restricted use pesticide should not be  subject to a fine for a
first offense as would an  "applicator for hire,"  but  instead should be sub-
ject only to a written warning.

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            UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                        WASHINGTON. D.C. 20460
                             FEB I 0 1986
                                                          orncc or
                                                   PMTICIDKS ANO TOXIC SU«ST*M>
MEMORANDUM

SUBJECT: FIFRA $7(c) Enforcement Response Policy

FROM:    A. E. Conroy II, Director1
         Office of Compliance Monitoring

TO:      Addressees

     Attached is the Enforcement Response Policy for the
Federal I.nsectlcide, Fungicide and Rodentlcide Act (FIFRA)
Section 7(c) Pesticide Producing Establishment Reporting
Requirement.  This policy is immediately effective and
supersedes the May 24, 1985 Interim Enforcement Response
Policy for the FIFRA §7(c) Pesticide Producing Establishment
Reporting Requirement.  This policy sets forth the appropriate
enforcement action to initiate for FIFRA §7(c) violations.
Please refer to Appendix C of the Enforcement Response
Policy (the last 2 pages of the document) for a summary chart
of the enforcement response policy.

     The following changes were made to the final policy
in response to comments regarding the April 26, 1985 draft
policy.

     o  Page 2, Persons Not Required to Report Production.
        The following sentence was Incorporated: "Also, any
        person who 1s a producer solely because he produces
        a custom blended pesticide is not required to report
        if he meets the requirements set forth in the FIFRA
        Tompliance Program Policy No. 3.4 entitled "Custom
        Blenders' ."

      o Page 5, Incomplete Reporting - Reporting in a Manner
        Inconsistent with the Regulations.

        - The timeframe for submitting missing Information was
          changed from 5 days to 10 days.

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                               .7.
        - The following sentence was incorporated to further
          explain what 1s meant by a minor omission of
          Information:  "Minor omissions of information
          are clerical errors and/or the omission of minor
          amounts of information as to reflect an oversight."

     o  Page 5, False Reporting/Major Omissions of Information -
        Reporting in a Manner Inconsistent with the Regulations.
        The following example concerning a major omission
        was Incorporated:  "An example of a major omission
        of information would be demonstrated by an establishment
        that does not report a pesticide which was produced
        1n the preceding year.  For Instance, an establishment
        which produced 5 different pesticides, but reported
        production of only 4 pesticides."

     o  Page 6, Administrative Civil Penalty FIFRA §14(a)(l).
        The timeframe for which civil  complaints should be
        issued was changed from 2 months to 75 days (2.5 months).

     o  Page 11, Violations, (3) Nonreporting Violation or
        Notably Late Reporting - Annual.  The following paragraph
        was incorporated:  "Producers  of pesticides in bulk form
        shall  be assessed a penalty in accordance with GBP Matrix
        A for the first nonreportlng violation.  Subsequent non-
        reporting violations warrant a penalty assessment from
        GBP Matrix C."

     o  Appendix A, Page A-5.  A Model Notice of Termination of
        Establishment Registration was added.

     o  Appendix C.  An Appendix C was added to the attached
        policy.  This appendix includes the Enforcement Response
        Chart and the Civil Penalty Matrix.

     Also attached, for your Information, is the Office of Compliance
Monitoring's response to comments concerning the draft policy.

     If you have any questions concerning this enforcement response
policy, please contact Claudia Goforth of my staff at FTS 475-6723.


Attachments

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                 COMMENTS HOARDING THE FIFRA $7
                   ENFORCEMENT RESPONSE POLICY
                        AND OCM'S RESPONSE


o  One commenter mentioned that the name "bulk producer"  should  be
   changed to producers of pesticide in bulk form.

   OCM changed the name of bulk producer to "producers  of pesticide
   in bulk form".

o  Many Regions questioned the practicality of issuing  civil
   complaints for violations within 60 days from the due  date  of
   the report.

   The policy has been changed whereby civil complaints are to
   be issued within 75 days from the due date of the report

o  Several Regions stated that the good faith adjustment  factor
   constituted a 40% reduction of penalty, not 20X as stated 1n
   the policy.

   According to 39 FR 27711, 7/31/74, good faith permits  a total
   reduction of 20%.

o  One Region said "The matrix, we firmly believe, should be
   revised to include lower penalties."

   OCM disagrees.  The information required under FIFRA §7(c)
   is used for regulatory purposes of risk assessment as  well  as
   for inspection and targettlng purposes.  OCM considers §7(c)
   violations to be serious.  This 1s due to the potential impact
   on the Agency's ability to conduct accurate risk assessments
   and compliance Inspections.  Therefore, the penalty  matrix
   has not been changed.

o  One commenter stated that it 1s unrealistic to expect  either
   a  State or Federal Inspector to respond by inspecting  a term-
   inated pesticide producing establishment.

   The tlmeframe for Inspection of a pesticide producing  establish-
   ment which has had its registration terminated was increased
   from one month to two months.  However, OCM does not believe
   that the number of establishments which have their registration
   terminated will increase.

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                              -2-
o  One Region stated that the chart on page 10 of the draft  polii
   is unnecessary and cumbersome.

   The chart, which is now located in appendix C, is designed
   for easy access by Regional  personnel  in determining the
   enforcement response for a specific violation.  The chart
   will remain in the policy since the majority of Regions
   agreed that the chart 1s an  effective  tool  for determining an
   enforcement response.

o  One Region requested that producers of pesticides in bulk
   form should receive a lower  penalty for a first time non-
   reporting violation.

   OCM agreed and changed the policy to Include a lower penalty
   assessment for the first time nonreporting  violation of
   producers of pesticides 1n bulk form.   This change was
   incorporated due to the unique factors which are associated
   with producers of pesticides 1n bulk form.

o  One Region requested that an example regarding major and
   minor omisions of information be included.

   OCM incorporated examples of major and minor omissions
   of information.

o  One Region stated that the time period for  which a report
   should be considered late 1s ten days.

   The majority of Regional comment agreed with the timeframe
   provided in the policy.  Therefore, to maintain national
   consistency, the timeframe for issuing civil enforcement
   actions for late reporting shall remain as  30 days from the
   February 1 due date.

o  Some commenters stated that  the firm should be granted
   10 days instead of 5 to submit the information which was
   omitted from report.

   The timeframe for submitting information was Increased to
   10 days.

o  One commenter stated that the notably  late  violation
   category should be deleted.

   OCM disagrees.  If a report  is received after the civil
   complaint has been prepared  (not issued) for a nonreporting
   violation, the establishment can no longer  be considered
   nonreporting since the Region now has  the report in its
   possession.  Therefore, a notably late reporting category

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                           -3-
was incorporated to cover Instances such as this.   It  is
important to note that the establishment is subject  to
the same civil penalty assessment  as an establishment  which
does not report.  OCM believes that a cutoff date  by which
all violators are subject to a penalty irrespective  of when
a Region issues its complaints is  necessary.  Otherwise the
treatment of a notably late reporter w.ill  vary depending  on
the region in which the establishment 1s located.   For
example, if a report is 65 days late and the Region  issues
its complaint by day 60 and another Region issues  its  com-
plaints by day 75, the enforcement response will  be  different
for notably late reporting versus  nonreporting,  although
the report is submitted on day 65.  In fact, there could  be
a difference in the enforcement response within  the  same
Region depending on the date an establishment's  complaint
i s s e n t.

One commenter felt a statement was needed which  explained
that the postmark date of mailed reports will be considered
as the submission date.

A statement such as this was included in the draft policy and
shall  remain in the final policy.

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                                     f:FP I 0 1986
     ENFORCEMENT RESPONSE POLICY FOR


  FIFRA SECTION 7(c)  PESTICIDE PRODUCING


   ESTABLISHMENT REPORTING REQUIREMENT
     Environmental  Protection Agency
Office of Pesticides and Toxic Substances
     Office of Compliance Monitoring
         Washington, D.C.  20460

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                        TABLE OF CONTENTS
 Pa"rt  f    IntrocfiTc t i on
 Persons  Regulated	1
 Requirements of FIFRA §7(c)	?
 Information Required 	  3
 Violations	  .  .	4
'Part  II    L~evTI~oT"Ac"tT?n'                         ~
 Notice  of Warning	5
 Administrative Civil Penalty	fi
 Termination of Establishment Registration  	   6
 Criminal  Sanctions	8
 Fa~r~t  TTT   Assessing An Administrative Civil  Penalty        ""
 Summary  of  the Penalty Policy 	   9
 Explanation of Penalty Policy	'	10
 Adjustment  Factors	11
 Penalty  Assessment When Business Size 1s  Unknown.  ...   12
 7rp~p~e"n~d~'i ces~~         ~"   ~
 Model  Notices	Appendix A
 Model  Civil  Complaints	Appendix R
 Section  7(c)  Enforcement Response Chart	Appendix C

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                         I:  INTRODUCTION
PoTicy Summary
     This policy sets forth the procedures which the Environ-
mental Protection Agency will follow in determining what level
of action to bring against establishments that violate section
7(c) of the Federal Insecticide, Fungicide and Rodenticide Act,
as amended (hereafter FIFRA or the Act).
                                  i
Background"""      _'._..

     Section 7(c) of FIFRA permits the Administrator to require
any producer operating an establishment registered under section
7 to submit a production report within 30 days after notification
of registration of his establishment and thereafter on an annual
basis.  The due date for the annual report Is stated in
40 CFR §167.5 as February 1 of every year.  Failure to submit  a
production report is a violation of the requirements set forth
in FIFRA §7(c) and violates section 12(a)(2)(L) of the Act.

     EPA considers failure to comply with this reporting require-
ment a serious violation.  Violations of the section 7 reporting
requirement impacts the Agency's risk assessment capability as
well as Its ability to effectively target inspections.  It is
also important to note that this is the major mechanism by which
EPA can determine what pesticides an establishment is producing.

Persons Regulated

     Any person producing a pesticide or device 1s subject to
section 7 and required to register his establishment with EPA.
In addition, section 7(c) requires all registered establishments
to submit an annual production report to the Agency.  The regula-
tions at 40 CFR §167.2(a) define which producing establishments
must report.

     Those producers who must comply with the reporting provision
of FIFRA §7 Include but are not limited to:

          o  Producers of registered pesticides;

          o  Producers of technical material;

          o  Producers of devices;

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                               -2-
          o   Producers of pesticide products  for export;

          o   Reformulators;

          o   Repackagers (Includes relabelers );

          o   Producers of pesticides 1n bulk  form;

          o   Foreign producers who export to  the United States;

          o   Producers of pesticides under an Experimental Use
             Permi t;

          o   Establishments which produce pesticides/devices
             under contract;

          o   Producers of active ingredients  (will be addressed in
             future FIFRA §7 regulations); and

          o   Custom blenders (see section "Persons Not Required to
             Report.")

     Establishments which did not produce over the past year or
years and are still registered with EPA as a  producing establish-
ment are  subject to this reporting requirement and must file a
report stating "zero production".  Therefore, any producer oper-
ating an  establishment registered under FIFRA §7 must file an
annual report, even if the registered establishment is not
currently producing.  Nonproducing registered establishments are
also subject to the same remedies as a registered establishment
that is actively producing.

Persons Not Required to Report Production	

     Any  person who 1s a producer solely because he produces a
custom blended pesticide is not required to report if he meets
the requirements set forth in the FIFRA Compliance Program Policy
No. 3.4 entitled "Custom Blenders".

Requirements of FIFRA 57(c)

Initial Report	

     When a producing establishment is registered, EPA provides
the pesticide establishment report form (EPA  Form 3540-16) to
the producer along with the assigned establishment number.
The completed form 1s to be submitted to EPA  within 30 days
after the receipt of the written notification of establishment
registration.  This pesticide establishment report is considered
as the initial  pesticide establishment report and is to be sub-
mitted by the establishment to the appropriate Regional  Office.

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                             -3-
In the case of foreign producers, their reports must be
submitted to the Office of Compliance Monitoring (OCM).

Annual Report	[	

     After submitting the initial report, producers are required
to submit production reports on an annual basis.  The due date,
as set forth in 40 CFR §167.5(c), is on or before February 1.

     The postmark date on the report shall be considered as
 the date of submission for reports mailed to the Regional Office

Request for an Extensio^	

     An establishment may request an extension from EPA concern-
Ing the due date for the annual production report.  EPA may grant
an extension if the request is made prior to the expiration of
the due date and the producer can present just cause regarding
the need for an extension.  Granting of the extension will
be at the discretion of the Regional Office, or OCM for
foreign producers.
Informalfon Req'ufre
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                              -4-
Violations
     There are five types of reporting violations:

          o Late Reporting;

          o Notably Late Reporting;

          o Nonreporting;

          o Incomplete Reporting; and

          o Falsification of Information in the Report.

     If a producer fails to submit a complete report by the
required due date or falsifies information in the report, he
may be charged with a violation under section 12(a)(2)(L),
7 USC §136j(a)(2)(L), and shall be subject to the remedies set
forth 1n this enforcement response policy.

Late Reporting	.

     For the purpose of this enforcement response policy,
enforcement action will be initiated if the required production
report is not submitted on or before the established due date.
A production report submitted within 1 to 30 days after the due
date shall be considered as a late report.  It is important
to note that reports submitted even one day after the due date
will be considered as a late report.

Notably Late Reporting and Nonreporting	

     If a producing establishment does not submit the annual
pesticide report within 30 days after the February 1 due date,
the establishment will be considered as nonreporting and assessed
the appropriate civil penalty.

     If a report is submitted after the 30th day past the due
date, but prior to the issuance of the civil complaint for non-
reporting, the establishment will be considered as filing a
notably late report and will be assessed the same civil penalty
as a nonreporting violation.  (Since the report had been submitted
the violation would no longer be nonreporting.)

Incomplete Reporting - Reporting in a Manner
Inconsistent with the Regulations	

     A report may be technically incomplete.  This violation
occurs when the producer has failed to submit all required infor-
mation.  The Agency recognizes that not all such omissions are
deliberate and its initial response to minor omissions in a
report will  be to telephone or write the submitter and attempt
to obtain the missing information.

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                              -5-
EPA considers minor omissions of information to be clerical
errors and/or the omission of minor amounts of information  as
to reflect an oversight.  If the submitter fails to provide
EPA with the required information within 10 days from the date
of the initial request, via letter, the report may then be
considered incomplete.  Consequently, the Agency shall  issue  a
FIFRA §9(c)(3) notice of warning.

     The notice of warning will provide the establishment with
20 calendar days to submit the necessary Information.  If a
producer operating an establishment commits a second or subsequent
(within a 3 year timeframe) Incomplete reporting violation,  he
will be subject to a civil penalty.
                                 i
False Reporting/Major Omissions of Information -
Reporting in a Manner Inconsistent with the Regulations

     The submitter who was negligent about consulting records
or performing calculations cannot claim to have reported all
reasonably ascertainable Information.  Such negligence may  be
treated as falsification since the ultimate result of failure
to meet the standard was the submission of false Information.
Furthermore, to knowingly falsify any Information contained  1n
the report is an unlawful act under FIFRA §12(a)(2)(M).  Knowing
or unknowing, major omissions are a violation of FIFRA $12(a)
(2)(L).

     An example of a major omission of information would be
demonstrated by an establishment that does not report a pesticide
which was produced in the preceding year. I.e., an establishment
which produced 5 different pesticides, but reported production
of only 4 pesticides.


                      II: LEVEL OF ACTION


     The available levels of action for violations of the
section 7 reporting rule Include notices of warning, admin-
istrative civil penalties, termination of establishment
registrations, and criminal sanctions.

Notice of Warning Under FIFRA §9(c)(3)  .

     The notice of warning is the appropriate enforcement action
for the following violations:

     o  Nonreportlng .- Initial Report.
        Failing to submit the initial production report within
        30 days after notification of the establishment regis-
        tration.  (Failure to report after the receipt of a
        FIFRA §9(c)(3) warning will result 1n termination of
        the establishment's registration.)

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                              -6-
     o  Late Reporting - Annual Report.
        First offense In filing a late report. (Please note
        that this refers only to those situations 1n which the
        Region has received the report within 30 days after the
        due date.)

    o   Incomplete Reporting - Minor Omissions of Information.

     Tha registrant will be given 20 calendar days to submit
the report, or the missing Information, after the receipt of a
notice of warning.  If the Agency does not receive the report
within the given tlmeframe, proceedings to terminate the estab-
lishment registration will commence (refer to section entitled
Termination of Establishment Registration for further explanation
and guidance).

     The FIFRA §9(c)(3) notice of warning should be sent via
certified mall with return receipt requested.  A sample notice
of warning for each applicable offense 1s located 1n Appendix A.

Administrative Civil Penalty FIFRA §14(a)(l)

     Issuance of a civil complaint proposing a penalty Is the
appropriate enforcement response for the following violations:

      o Late Reporting - Second or Subsequent Violation Within
        a Three Year Tlmeframe From the First Violation;

      o Notably Late Reporting;

      o Nonreportlng;

      o Incomplete Reporting - Second or Subsequent Violation '.with-
        in a three year tlmeframe); and

      o Falsification of Information Contained 1n the Pesticide
        Report, or Major Omissions of Information.

     The civil complaint should be Issued within 75 days (2.5
months) after the February 1 report due daTe^  C~1v1l penalties
should be assessed 1n accordance with the guidelines and pro-
cedures established 1n Part III of this policy.  For additional
guidance In assessing a civil  penalty see the "General FIFRA
Compliance/ Enforcement Guidance Manual", 1983, Chapter 7,
entitled "Administrative Actions: C1v1l".

Termination of Establishment Registration

Termination For Cause	

     The regulations relating  to the registration of a pesticide
producing establishment (40 CFR §167.3 and 7 USC §136e) state

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                               -7-
that an establishment's registration will remain In effect so long
as the establishment submits the required production report.   If
the producing establishment falls to submit a production report
within 20 calendar days after the date of receipt of the notice  of
warning or civil penalty, EPA will  initiate procedures to terminate
the establishment's registration.  This action will be Independent
of any other enforcement action.

     To terminate an establishment's registration, a Notice of
Intent to Terminate must first be issued to the producing estab-
lishment.  This notice will Identify the violation and warn the
producer that the registration for his establishment will be
terminated if the report in question 1s not received within the
next 20 calendar days..  The Notice of Intent to Terminate
Registration should be sent with the Initial enforcement action
or, at the latest, by May 1, or 20 days before the designated
deadline of termination.  (A sample Notice of Intent to Terminate
Registration is located 1n Appendix A, page A-4).

    Regions should assure that the establishment's registration
1s terminated on or before June 1 if the producer has not submitted
his annual report within the timeframe set forth by the Initial
enforcement action (I.e., notice of warning or civil penalty).

Foreign Producers	

     The Office of Compliance Monitoring will Issue a Notice of
Intent to Terminate to any foreign producer who fails to submit
a report within 30 days from the due date.  If the report 1n
question is not received within 30 calendar days from receipt
of the Notice of Intent to Terminate, the establishment's
registration will be terminated.  Regions shall be Informed of
the termination of foreign establishment's registration (along
with the Department of Treasury - U.S. Customs Service).  This
is to prevent entry of a pesticide product from a foreign estab-
lishment which has had Its establishment registration terminated.

Inspections	

     Inspection of the producing establishment, for which regis-
tration has been terminated, should be conducted within 2 months
following termination of the establishment's registration.  This
Is to ensure adherence to the provisions of FIFRA §7.

Public Notification of Establishments Which Cannot
Be Located

     By July 1 of each yea.ri all Regional Offices shall submit
a listing to the Compliance Division of OCM, which identifies
those establishments for which registrations are to be terminated,
but have not been notified because the Regions have been unable
to locate the establishment.

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                               -8-
OCM will subsequently compile a listing of all those establish-
ments which cannot be located and publish the establishment's
name and number 1n the Federal Register for official public
notification of the termination of the establishment's
reglstratlon.

Rereglstrati on After Termination	

    Producers desiring rereglstratlon of their establishment
must apply for establishment registration pursuant to the
requirements of 40 CFR §167.2.

Requested Termination	

     Termination of an establishment registration may also occur
upon the request of the establishment or parent company.  This
typically happens as a result of the establishment: 1) going out
of business: 2) no longer producing pesticides or; 3) no longer
falling under the purview of FIFRA §7.  Termination of an estab-
lishment registration 1n such situations should not be confused
with termination for cause.

Criminal Sanctions FIFRA §14(b)(l)

     Criminal sanctions pursuant to §14(b)(l) of the Act will
be sought 1n situations that when measured by the nature of
the conduct and the compliance history of the subject, reflect
the most serious cases of misconduct.

     For FIFRA §7, the Agency may consider criminal action for
knowing and willful falsification of the Information provided
to the Agency.  Since the Agency may terminate the registration
of producers who fall to report, EPA will generally not consider
criminal action for nonreportlng violations.
       PART III:  ASSESSING AN ADMINISTRATIVE CIVIL PENALTY
Summary or the penalty Policy	

     All civil administrative penalties should be calculated by
selecting the appropriate gravity based penalty (GBP) and making
appropriate modifications based on application of the adjustment
factors 1n the general FIFRA C1v1l Penalty System.

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CIVIL PENALTY MATRIX





  I        II        III
IV
A. Late Reporting
Violation -- Sub-
sequent Violation
§12(a)(2)(L)
B Incomplete
Reporting --
Producer Does Not
Respond to Notice
of Warning. Also
Those Producers
Who Commit a Sub-
sequent Violation
§12(a)(2)(L)
C. Notably Late
Reporting or
Nonreporting
Violation -•
Annual Report
§12(a)(2)(L)
0. Submission of
False §7 Report
Data
§§12(a)(2)(M) &
12(a)(2)(N)
200
320
320
500
400
t
800
800
1250
600
1760
1760
2750
800
2720
2720
4250
1000
3200
3200
5000

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                              -10-
Explanatlon of Penalty Policy
Calculation of the Gravity Based Penalty	

     The Gravity Based Penalty (GBP), for each type of violation
1s to be selected from the matrix provided on page 9 of this
document.

Violations	

1) Subsequent Late Reporting.

        This violation concerns the producing establishment
   which has received a previous FIFRA §9(c)(3) notice of warning
   for submitting a late report within 3 years from the present
   reporting year.

        Since the actual report 1s 1n the possession of the
   Agency, a lesser penalty 1s appropriate.  Penalties shall  be
   assessed according to Penalty Matrix A.

2) Incomplete Reporting - Second or Subsequent Violation.

        When Information 1s omitted from the pesticide report,
   the Agency will contact the producing establishment and request
   the Information.  If the Information 1s not Immediately accesjfl
   1ble, the producing establishment may then be granted 10  daysH
   to submit the necessary Information, via letter to the proper^
   EPA Region, (or Headquarters in the case of foreign establish-
   ments).  If the registrant does not respond by submitting  the
   requested Information within 10 days, they will be considered
   as filing an Incomplete report and subject to a civil penalty.
   In such cases the Region 1s to assess a penalty in accordance
   with GBP Matrix B.

3) Notably Late Reporting or Nonreporting Violation -
   Annual Report.

        A production report 1s considered notably late 1f the
   report 1s submitted to the Agency more than 30 days after  the
   due date, but prior to the Issuance of the civil complaint for
   nonreportlng.

        Nonreporting results when a producer operating an estab-
   lishment does not submit a report to the Agency.

        Notably late reporting and nonreportlng violations receive
   the same penalty assessment.  Penalties shall be assessed  in
   accordance with GBP Matrix C, unless the establishment falls
   Into one of the following categories.

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                              -11-
       A. Nonreportlng by Producers of Pesticides 1n Bulk Form -

               Producers of pesticide 1n bulk form shall  be assessed
          a penalty 1n accordance with GBP Matrix A for a first
          time nonreporting violation.  Subsequent nonreportlng
          violations warrant a penalty assessment from GBP Matrix  C.

       B. Nonreportlng by Establishments with Zero Production -

               When a nonprodudng establishment falls to report,
          EPA will Issue a civil complaint 1n accordance  with GBP
          Matrix C.  If the producer requests termination of his
          establishment registration within 20 calendar days
          after the civil complaint has been Issued, the  civil
          penalty may be reduced to zero.  Please note that
          reduction of a penalty 1s at the discretion of  EPA.

               In the event the producer reregisters his  estab-
          lishment, and commits another nonreportlng violation,
          he will be subject to a civil penalty, without  the
          option of the penalty being reduced to zero.

4) Falsification of Report Data.

       When a producer knowingly falsifies any Information
   submitted to EPA pursuant to section 7, the proposed penalty
   shall  be selected from GBP Matrix D.  Reporting false  Information
   1s a serious violation, one which warrants an Increased penalty
   and may subject the producer to criminal proceedings.   Please
   note that submission of a report with major ommlslons  of
   Information which are not "knowingly" omitted 1s a violation
   of FIFRA §12(a)(2)(L).

       An example of false reporting 1s an establishment  which
   produces 5 pesticides yet only reports production of 4
   pesticides.  If the Agency discovers that an establishment
   actually produced 5 pesticides 1n the past year, and not 4
   as reported, the establishment would be cited for falsification
   of Information.

Adjustment Factors

     The  FIFRA C1v1l Penalty Policy specifies that the penalty
1s to be  adjusted by applying appropriate adjustment factors.
Several adjustment factors are particularly relevant to violations
of this reporting requirement.  Adjustment factors are outlined
1n the General FIFRA C1v1l Penalty Policy; however the following
factors are especially applicable to violations of this reporting
requi rement:

     o  History of prior such violation;

     o  Effect on person's ability to continue in business; or

     o  Good faith attitude (up to 20% reduction).

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                              -12-
Penalty Assessment When BuslneTF Size 1s Unknown

     When no Information concerning a producing establishment's
size of business can be found, the Agency will  propose the penalty
at the GBP Category V Size of Business Level.  The Category V
amount shall be the penalty proposed unless the establishment
can verify to EPA, at the expense of the establishment, Us
size of business.  The proposed penalty will  subsequently be
adjusted to reflect the documented Information  demonstrating the
establishment's size of business.  (A sample  size of business
letter which may be used In the aforementioned  Instance can be
found 1n Appendix B.)

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APPENDIX A

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                      Model  Notice of  Warning


 CERTIFIED MAIL
 RETURN RECEIPT REQUESTED

 EPA Est. 000-00

 Establishment's Address

 Gentlemen:

                        NOTICE OF  WARNING

    FOR FAILING TO FILE INITIAL PESTICIDE ESTABLISHMENT  REPORT

      This letter constitutes a warning  pursuant  to  section
 9(c)(3) of the Federal Insecticide,  Fungicide,  and  Rodentldde
 Act, as amended, (hereafter FIFRA),  7 USC section  136g(c)(3).
 The Environmental Protection Agency  1s  hereby advising  you
 that you are In violation of section  12(a)(2)(L) of FIFRA,
 7 USC §136j(a)(2)(L), by falling  to  file the  Initial  pesticide
 production report within thirty (30)  calendar days  after  the
 receipt of notification of registration for your establishment
 which Included the EPA Production Report Form.   The afore-
 mentioned Information was sent via certified  mall  to (ESTAB-
 LISHMENT'S NAME, ADDRESS) and was received on (DATE OF  RETURN
 RECEIPT).

      You are hereby advised to file  the Initial  report  with this
 Regional Office, within twenty (20)  calendar  days.   If  you have
 not filed the Initial pesticide production report  within  the
 twenty (20) calendar days, you shall  be subject  to the  remedy  set
 forth 1n Part 40 Code of Federal  Regulations  §167.5, whereby the
 registration of this producing establishment  shall  be terminated.

      All necessary measures are taken by the  Agency to  preclude
 the Issuance of a notice of termination of registration.   How-
 ever, If the report Is not received  within the given tlmeframe
 of this notice, proceedings to terminate your establishment's
 registration will be pursued.

      Please note that according to FIFRA, no  person shall produce
any pesticide subject to FIFRA 1n  any State unless  the establish-
ment in which 1t Is produced 1s registered with the Administrator.

      If you have any questions concerning this matter,  please
 contact (NAME AND PHONE NUMBER).


                              Sincerely  yours,

                              Signature
                              (Name and  Title)

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                              -2-


                    Model Notice of Warning


CERTIFIED MAR
RETURN RECEIPT REQUESTED

EPA EST.  000-00

Establishment's Address

Gentlemen:

                       NOTICE OF WARNING

    FOR FILING A LATE ANNUAL PESTICIDE ESTABLISHMENT REPORT

     This letter constitutes a warning pursuant to section
9(c)(3) of the Federal  Insecticide Fungicide and Rodentldde
Act. as amended (FIFRA), 7 USC section 136j(c)(3).  The
Environmental Protection Agency 1s hereby advising you that
you are 1n violation of section 12(a)(2)(L) of FIFRA, 7 USC
§136j(a)(2)(L), by not  filing the annual pesticide report
required by FIFRA §7(c), on or before the February 1 due date
The report filed by your producing establishment located at
(address) was received  by this Office on ( DATE ).

     You are hereby advised to comply with the regulations
promulgated at 40 CFR §167.5(c) which states the due date
annual reports as being February 1 of each year.  NoncompHan
with this reporting requirement In the future may subject your
producing establishment to an administrative civil penalty.

     If you have any questions concerning this notice of warning,
please contact (NAME) at (PHONE NUMBER).


                                 Sincerely yours,


                                 (Signature
                                 Name and Title)

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                               -3-
           Model Notice of Warning for Falling to File a
                    Complete Pesticide Report


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

EPA EST. 000-00

Establishment's Address

Gentlemen:

                        NOTICE OF WARNING

        FOR FAILING TO SUBMIT A COMPLETE PESTICIDE REPORT


     This letter constitutes a warning pursuant to section 9(c)(3).
7 USC section 136j(c)(3)of the Federal Insecticide, Fung1c1d« and
Rodentldde Act, as amended, (FIFRA).  The Environmental Protection
Agency 1s hereby advising you that you are 1n violation of section
12(a)(2)(L) of FIFRA, 7 USC section 136(a)(2)(L). by falling to
submit the Information which was missing from the annual pesticide
report received on ( DATE ).  This Office contacted you on ( DATE )
via (letter or telephone) to request the missing Information
whereby your establishment was allocated ten (10) days to submit
the Information to this Office.  The Information required 1n the
pesticide report may be found at 40 CFR 167.5(a).

     You are hereby advised to submit the Information requested
within twenty (20) calendar days from the receipt of this Notice
of Warning.  Failure to do so may subject your producing establish-
ment to an administrative dvll penalty.
in ^ 11 to V w ** 11 w w in i ' * i ^ *» i w to • v « ' «»i v • •  yr^vfwi * J •


     If you have any questions  concerning th1
contact (   NAME	)  at ( PHONE i ).
s matter, please
                         Sincerely yours,
                         Signature
                         (Name and Title)

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                                -4-
   Model Notice of Intent to Terminate Establishment Registration,


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

EPA Est. 000-00

Establishment's Address

Gent!emen:


      NOTICE OF INTENT TO TERMINATE ESTABLISHMENT REGISTRATION


     You are hereby advised of the Environmental  Protection Agency
Intention to terminate the registration of your pesticide producing
establishment located in (city and state)  pursuant to 40 CFR §167.3
and section 7 of the Federal Insecticide,  Fungicide and Rodenticide
Act, (FIFRA), as amended, 7 USC §6136, in  response to your failure
to submit the production report required by section 7(c) of FIFRA
and 40 CFR §167.3.

     Your failure to file the required report by  February 1, 19
has already subjected you to the (NOTICE OF WARNING, CIVIL OR
CRIMINAL PENALTY) provision of the Act.  Failure  to submit the
required reports within twenty (20) calendar days from the date
this notice will result in the termination of your establishment
registration, which shall be effective upon the Issuance of a
Notice of Termination of Establishment Registration.  Submission
of the required report within the twenty (20) day time period
shall  not affect your liability under the  provisions of FIFRA,
whereby the enforcement action which had previously been Initiated
against your establishment Is still 1n effect.  However, termination
of your establishment registration 1s an enforcement action. Inde-
pendent of any other.

     In the event you do not respond to this notice, you should
assure yourself that all necessary measures will  be taken to
preclude any production not 1n compliance  with FIFRA or the
regulations.


                           Sincerely yours,


                           Signature
                           (Name and Title)

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                              -5-
                  Model Notice of Termination of
                    Establishment Registration


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

EPA Est. 000-00

(Company name)
(Address)

Subject:  (Establishment registration number)


      NOTICE OF TERMINATION OF ESTABLISHMENT REGISTRATION


Gentlemen:

     The Environmental Protection Agency hereby Informs you that
the Agency  has terminated the registration of your establishment,
located 1n  (city and state), pursuant to Section 7 of the Federal
Insecticide, Fungicide, and Rodentlcide Act, (FIFRA) as amended,
7 U.S.C. §136 and 40 C.F.R. §167.3.  The Agency has taken this
action based on your failure to submit reports required by Section
7(c) of the Act and by 40 C.F.R. §167.5.

     You may apply for reinstatement of your establishment
registration at any time subsequent to the termination of your
establishment registration.  However, the reinstatement of your
establishment registration will be expressly conditional upon
the Agency's receipt of your delinquent pesticide establishment
report(s) together with an application for establishment regis-
tration (EPA Form 3540-16).

     Please be assured that all necessary measures shall be
taken to preclude any action at your establishment which is
not in compliance with the Act.  Production of pesticides,
active ingredients, or devices in an unregistered establishment
or in an establishment whose registration has been terminated
1s an unlawful action subject to the civil and criminal penalty
provisions  of the Act.


                         Sincerely yours,


                         Signature
                         (Name, and Title)

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APPENDIX B

-------
CERTIFIED MAIL
RETURN RECEIPT REQUESTED

(Est. name and address)

Dear (         ):


     Enclosed 1s an administrative Civil  Complaint alleging
violations documented under the Federal Insecticide, Fungicide,
and Rodenticide Act, as amended (FIFRA).

     In determining the amount of the penalty, the Agency is
required to consider the size of the business of the person
charged, the effect on the person's ability to continue in
business, and the gravity of the violations.  The Guidelines
for the Assessment of Civil Penalties (39 FR 27712) set forth
the following size-of-business gradations, based on gross annual
sales:

     Category I                 Less than $100,000
     Category II                $100,000  - $400,000
     Category III               $400,000  - $700,000
     Category IV                $700,000  - $1,000.000
     Category V                 In excess of $1,000,000

     In the absence of specific information on your firm's size
of business, as determined by gross annual sales, it has been
assumed for purposes of this Complaint that your firm is a Cate-
gory V size of business.

     Please be assured that if your firm  has been placed in
Category V incorrectly, the proposed penalty will be adjusted
upon submittal of reliable financial Information indicating
another category is appropriate.  If you  have any questions
concerning this matter, please contact (  name ) at ( phone »).


                          Sincerely yours,

                          Signature
                          (Name and Title)


Enclosure

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APPENDIX C

-------
                        SECTION 7(c) EN
                        HENT RESPONSE CHART
VIOLATION/
UNLAWFUL ACT
OF FIFRA
  VIOLATION
  CATEGORY
 INITIAL
 ACTION
ENFORCEMENT
FINAL REMEDY/ACTION
WHEN NO RESPONSE TO
INITIAL ACTION
LATE REPORTING
§12(a)(2)(L)
Annual Report-
1st Violation
§9(c)(3) — Notice of
Warning (Regions must
already have the report)
INCOMPLETE
REPORTING
§12(a)(2)(L)
Annual Report-
1st Violation
§9(c)(3) -- Notice of
Warning with 20 days
Allocated for Response
NONREPORTING
§12(a)(2)(L)
Initial  Report
1st Violation
§9(c)(3) •- Notice of
Warning with 20 days
Allocated for Response
Plus a Notice of Intent
to Terminate
                 Termination of
                 Establishment's
                 Registration
LATE REPORTING
§12(a)(2)(L)
Annual Report--
Subsequent
Violation
within 3 Years
Civil Penalty (See GBP
Matrix A)
INCOMPLETE
REPORTING
§12(a)(2)(L)
Annual Report--
Subsequent
Violation
Civil Penalty (See GBP
Matrix B) -- 20 days
Allocated to Submit
Missing Information --
Notice of Intent to
Terminate Sent Along
with Penalty
                 Termination of
                 Establishment's
                 Registration

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                SECTION 7(C) ENFORCEMENT RESPONSE CHART (CONTINUED)
VIOLATION/
UNLAWFUL ACT OF
FIFRA
    VIOLATION
    CATEGORY
INITIAL ENFORCEMENT
ACTION
FINAL REMEDY/ACTION
WHEN NO RESPONSE TO
INITIAL ACTION
NOTABLY LATE OR
NONREPORTING
§12(a)(2)(L)
    Annual Report--
    All Violations
Civil Penalty (See GBP
Matrix C, except for
producers of pesticides
In bulk form - 1st time
violation see GBP
Matrix A) Notice of
Intent to Terminate Sent
Along with Penalty
Termination of
EstablIshment*s
Registration
FALSIFICATION
OF INFORMATION
§§12(a)(2)(M)
& 12(a)(2)(N)
MAJOR OMISSIONS
INFORMATION
§12(a)(2)(L)
    1st and/or
    Subsequent
    Violation
OF
Civil Penalty -• (See
GBP Matrix D), Notice of
Intent to Terminate Sent
Along with Penalty, or
May Be Subject to
Criminal  Action
Termination of
Establishment's
Registration

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CIVIL PENALTY MATRIX FOR SECTION 7(c)
 I        II        III       IV
A
B
C
D
200
320
320
500
400
800
800
1250
600
1760
1760
2750
800
2720
2720
4250
1POO
3200
3200
5000

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                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	1

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 Recordkeeping 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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                               -ii-
     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 RODENTIODE 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 FEFRA 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 FTFRA
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 FTFRA 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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                                         -2-
                           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
FTFRA 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 (or the Good Laboratory Practice Standards, and the FIFRA section 19 regulations
       will be forthcoming.

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                                         -3-
                     DETERMINING THE LEVEL OF ACTION
      Once the documentation of a FTFRA violation 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
admissibility of that shipment. However, under the U.S. Customs' regulations for the
enforcement of section 17(c) of FIFRA (19 CFR Part 11110 - 11117), 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 to
respond to 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)(l)
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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                                          -5-
Sections 9Tc₯3) and
       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 a  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 CSSURO)	

       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 FIFRA 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, anc
           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 is one presenting a direct threat to human health or the environment by its use (e.g., a water treatment device
   whose labeling makes false, misleading, or fraudulent claims to purify raw well water or other untreated water supplies). For
   nonhazardous devices (e.g., an electromagnetic rodent repelling device) that are misbranded. Agency policy is to complete civil penalty
   proceedings before issuing a SSURO.  See December 19, 1979 Memorandum: "Enforcement Actions Concerning Nonhazardous
   Pesticide Devices."

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                                          -7-
Discretionarv 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.
Injunctive 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  relief, 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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                                          -9-
       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 reb'ef 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
use or unclassified pesticide as  a service in controlling pests but does not deliver any

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                                              -10-
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.*

       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 171.11(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 "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(aXl) and 14(bXl) of FIFRA.

       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(bXl) of FIFRA

       Any applicator, including an applicator who is certified, who holds or applies a general use pesticide (GUP) or an
       unclassified pesticide in violation of FIFRA for that pesticide will be subject to the lower penalties set forth in FIFRA
       sections 14(aX2) and 14(bX2).

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                                           -11-
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 FEFRA. 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 purposes of this section of the policy, EPA will not distinguish between commercial and private applicators.
       Consideration of applicator status is inherent in the policy in that suspensions have a more substantial impact on
       commercial applicators, affecting their primary business activity.

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                                          -12-
       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 commercial applicators who violate
restricted use  pesticides recordkeeping requirements  [see 40 CFR 171.1 l(c)(7); 40 CFR
171.11(f)(l)(iii)J.  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 Manual).

       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, to 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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                                         -13-
           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
           $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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                                         -14-
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 Gean 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 parties

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                                          -15-
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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                                         -16-
Press Releases/Advisories. Etc.
    Regions may, at their discretion, issue a press release/advisory to notify the public
of a person's violation of FTFRA.  However, the issuance of press release/advisoiy 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 FDFRA.

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                                          -17-
                 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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                                          •18-
       Computation of the penalty amount is determined in a five stage process in
consideration of the FTFRA 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
Table 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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                                          -19-
       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 cfvfl penalty
will be the statutory maximum of $500.  Subsequent violations will be assessed using the
FIERA section 14(a)(2) civil penalty matrix below.

                                       TABLE 1
                              CIVIL PENALTY MATRIX
                            FOR FIFRA SECTION 14(aXl)

                                    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
80Q
II
1,000
800
600
III
1,000
600
500
       This 14(a)(2) matrix is only for use in determining civil penalties issued subsequent to a notice of warning or following a
       citation for a prior violation, or in the case of a Tor hire" applicator using a registered general use pesticide, subsequent
       to the issuance of a civil penally of $500.

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                                          -20-
Size of Business
       In order to provide equitable penalties, the civil penalties that will be assessed
for violations of FIFRA wQl 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 genera] 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)J, 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:

                    I      -      over $1,000,000
                    II     -      $300,001 - $1,000,000
                    m           $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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                                          -21-
       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 I size 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 lever 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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                                             -22-



                                          TABLE3


              Total Gravity Value                Enforcement Remedy


                  3 or below                No action, Notice of Warning, or
                                           50% reduction of matrix value.*

                      4                    Reduce matrix value 40%

                      S                    Reduce matrix value 30%

                      6                    Reduce matrix value 20%

                      7                    Reduce matrix value 10%

                  8 to 12                   Assess matrix value

                      13                   Increase matrix value 10%**

                      14                   Increase matrix value 15%**

                      15                   Increase matrix value 20%**

                      16                   Increase matrix value 25%**

                 17 or above                Increase matrix value 30%**
            *   50% reduction of matrix value is recommended where multiple count violations exist.
            ** Maun value can only be increased to the statutory maximum of $5,000 per offense for
               persons under FIFRA section 14
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                                          -23-
Ability 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 wfll generally not collect a total civil penally 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).41  The latter two are described below.

Four percent  of gross sales.  The average gross income (from ajl 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's ability to pay may be provided in future guidance.

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                                           -24-
        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  civil 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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                                            -25-
       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 FTFRA 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 violations which can be documemed is both per sate and per shipment are to be calculated only is either
       per sale or per shipment, whichever is more appropriate based on the supporting documentation, and whichever approach
       yields the highest civil penalty.  For example, if Person A has a violation involving 1 sale and 2 shipments, and Person B
       has a violation involving 2 sales and 1 shipment, both persons would be charged for 2 violations of FIFRA (Person A is
       charged for 2 shipments and Person B is charged for 2 sales).

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                                          -26-
       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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                                         -27-
Factual Chances
       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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                                         -28-
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 (SWO	

       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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                                         •29-
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 Agency
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 of 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 FIFRA until 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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                                         -30-
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 uncollected 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: (3) 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.

-------
                                         -31-
       Thc 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 civi] 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.

-------
          APPENDIX A






FDFRA CHARGES AND GRAVITY LEVELS

-------
                                         A-l
 FIFRA
SECTION
 FITS
CODE
 FIFRA CHARGES AND GRAVTTV LEVELS


	VIOLATION  	
LEVEL
2(q)(D(A)
  1AA   Sold or distributed a pesticide NOT REGISTERED
         under section 3 or was CANCELLED or SUSPENDED,
         which was not authorized by the Administrator.

  1AB   Registrant, wholesaler, dealer, retailer, or other
         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
         distribution differed substantially from those
         accepted in connection with registration.

  IBB   Registrant, wholesaler, dealer, retailer, or other
         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
         DIFFERED  from the composition represented in the
         registration.

  IDA   Sold or distributed a pesticide which has not
         been COLORED or DISCOLORED pursuant to
         section 25(c)(5).

  1EA   Sold or distributed a pesticide or device which is
         MISBRANDED in that the label has a statement, design,
         or graphic representation which is false or misleading.

  1EB   Sold or distributed a pesticide or device which is
         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 CHARGES AND GRAVITY LEVELS
 FIFRA
SECTION
 FTTS
CODE
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
SECTIQN
 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; (Hi) 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, 1,8, 11 or 19.

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                                         A-4
 FIFRA
SECTION
 FTTS
CODE
 FIFRA CHARGES AND GRAVITY IJEVELS


	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.
                                                           2


                                                           2

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                                     A-5
 FIFRA
SECTION
                      FIFRA CHARGES AND GRAVITY LEVELS
 FITS
CODE
VIOLATION
LEVEL
12(a)(2)(J)


12(a)(2)(J)


!2(a)(2)(K)



12(a)(2)(K)



12(a)(2)(K)


12(a)(2)(K)


!2(a)(2)(K)
!2(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.
                                            3


                                            2


                                            2

-------
                                         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)
7(c)(2)
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, anv 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
 FITS
CODE
 FIFRA CHARGES AND GRAVITY LEVELS


	VIOLATION
LEVEL
12(a)(2)(0)



12(a)(2)(P)


I2(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 compliance 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 violations 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 serious or widespread2
harm to the environment (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.
Minor7 potential or actual harm to
the environment, neither widespread
nor substantial.

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                                         B-2
 VIOLATION
            I
VALUE    |
CIRCUMSTANCES
 GRAVITY OF
 MISCONDUCT

Compliance4
  History
                                       I
                                0
Culpability5
                                2

                                2

                                0
                   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
                   willful and did not result from
                   negligence. Violator instituted
                   steps to correct the violation
                   immediately after discovery of
                   the violation.

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                                                              B-3
                                            APPENDIX B FOOTNOTES
 •*   The gravity adjustment criteria in Appendix B should not be used for recordkeeping and reponing violations.  Therefore, Qnt-iime civil
    penalties for recordkeeping or reponing violations should be attcwd at  the matrix value, while subsequent penalties should be
    increased by an increment of 30% (up to the statutory maximum).

 2  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.

 3  For the purposes of this ERP, minor harm refers to actual or potential harm which is, or would be of short duration, DO lasting effects
    or permanent damage, effects are easily reversible, and harm does not, or would not result in significant monetary loss.

 '   The following considerations apply when  evaluating compliance history for the purposes of Appendix B:
                                                                   •  \
    (a)      In order to constitute a prior violation, the prior violation mm have renilted in: (1) a final order, either as a result of an
             uncontested complaint, or as a result of a contested complaint  which is finally resolved against the violator, (2) a consent
             order, resolving a contested or uncontested complaint by the execution of a  consent agreement; (3) the payment of a civil
             penalty by the alleged violator  in response to the complaint, whether or hot 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 be  considered a prior violation for the purposes of the gravity adjustment
             criteria, since no opportunity has been given to contest the notice.  Additionally, a stop sale, use, or removal order (SSURO)
             issued under F1FRA section 13 will  not be considered as compliance history.

    (b)      To be considered a compliance history for the purposes of Appendix B, the violation  must have occurred within five yean of
             the present violation.  This five-year period begins  on the date of a final order, consent order, or  payment of a civil penalty.

    (c)      Generally, companies with multiple establishments  are considered as one when determining compliance history.  If one
             establishment of a company commits a F1FRA violation, it counts as history when another establishment of the same
             company, anywhere in the country, commits another FIFRA violation.

 '   EPA enforcement  officials are not required to determine culpability at the lime the complaint is issued  (especially if this information is
    not readily available).  EPA enforcement officials may instead assign a weighting factor of 2 (culpability unknown), at the time of the
    issuance of the complaint.  Culpability adjustments may be reconsidered during settlement negotiations.

6   The Agency may also consider criminal proceedings for "knowing and willful" violations.  See the "Criminal Proceedings" section of this
    ERP.

-------
    APPENDIX C






SUMMARY OF TABLES

-------
                                   C-l

                     SUMMARY OF TABLES
                                 TABLE 1
                     FIFRA CIVIL PENALTY MATRICES
FIFRA SECTION
        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
i i i i
        FIFRA SECTION 14CiV2V

             SIZE OF BUSINESS
LEVEL
level 1
level 2
I
level I
I
1,000
1,000
•00
II
1,000
800
600
HI
1,000
600
500
                                  • This matrix is only for use 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 KOO.
                                 TABLE 2

                     SIZE OF BUSINESS CATEGORIES
Section 14fayn violators:
        Section 14fa1C2) violators:
I
n
HI
over 51,000,000
$300,001 • $1,000,000
SO - $300,000
I
II
III
over $200,000
$50,001 • $200,000
SO • $50,000
                                 TABLE 3

                    GRAVITY 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 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%***
        Use Appendix B to determine Gravity Values.
        50% reduction of matrix value is recommended where multiple count violations exist.
        Matrix value can onfy be increased to the statutory maximum.

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          APPENDIX D
FEFRA CIVIL PENALTY CALCULATION
         WORKSHEET

-------
                                         LM
                 FIFRA CIVIL PENALTY CALCULATION WORKSHEET
RESPONDENT
ADDRESS


DOCKET NO.
DATE

Appendix A
1. Statutory Violation
2. FITS Code
3. Violation Level
Table 2
4. Violator Category -
§14 (a) (1) or §14 (a) (2)
5. Size of Business Category
Tabl* 1
6. Base Penalty
ADoendixB
7. Gravity Adjustments:
a. Pesticide Toxicity
b. Human Harm
c. Environmental Harm
d. Compliance History
e. Culpability
f. Total Gravity
Adjustment Value
(add items 7a - 7e)
Table 3
g. Percent Adjustment
h. Dollar Adjustment
8. Final Penalty*
(item 7h from item 6)

m~i- 1*.
9. CoiTitiinsd Total Psnalty
(total of all Columns
^/•vi^ 1 *i rtA Q aVs^vtrA\



PREPARED !

count 1


. .









•:










JY

count 2

i
v. <
s








»












count 3

























count 4







>












           * NOTE: The final penalty in each column of line 8 cannot exceed the statutory maximum.

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                                           D-2
               FIFRA CIVIL PENALTY CALCULATION WORKSHEET (cont)
                               count
count
count
count
 1. Statutory Violation

 2. FITS 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. Compliance History

   e. Culpability

   f . Total Gravity
      Adjustment Value
    (add items 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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            ENFORCEMENT RESPONSE POLICY
                       FOR THE
FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT
   GOOD LABORATORY PRACTICE (GLP) REGULATIONS
                Office of Compliance Monitoring
              Office of Pesticides and Toxic Substances
               U.S. Environmental Protection Agency

                     September 30,1991

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                       TABLE OF CONTENTS
INTRODUCTION  	1

REQUIREMENTS OF THE FIFRA GLPS 	2
     Regulated Community 	2
          Liability 	2
          Studies Covered	 3
     Violations	3
          Violations Related to a False Compliance Statement .4
               FIFRA §§ 12(a)(2)(M) and 12(a)(2)(Q) 	4
          Violations Not Related to the Compliance Statement..4
               FIFRA Section 12(a)(2)(B)(i) 	5
               FIFRA Section 12(a)(2)(M) 	6
               FIFRA Section 12(a)(2)(Q) 	6
               FIFRA Section 12(a)(2)(R) 	7
          Multiple Violations 	7

LEVELS OF ACTION 	8
     Notices of Warning 	8
     Civil Administrative Penalties	9
     Criminal Proceedings	10

REFERRALS	11
     Office of Pesticide Programs  	11
     Office of Administration ...	12

APPENDIX GLP-A - FIFRA CHARGES AND GRAVITY LEVELS FOR
                 CIVIL PENALTIES ASSESSED FOR VIOLATIONS
                 OF THE FIFRA GLPs 	GLP-A-1

APPENDIX GLP-B - GUIDANCE FOR DETERMINING WHETHER TO
                 ASSESS A GLP VIOLATION UNDER FIFRA
                 SECTION 12(a)(2)(Q) AS A HIGH, MIDDLE,
                 OR LOW LEVEL VIOLATION	GLP-B-1

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9/30/91
                ENFORCEMENT RESPONSE POLICY FOR THE
       FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT
            GOOD LABORATORY PRACTICE (GLP) REGULATIONS
                               INTRODUCTION
      This policy sets forth the procedures that will be used to determine the
appropriate enforcement response for violations of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) Good Laboratory Practice Standards (GLPs) found at
40 CFR Part 160. This policy is a supplement to the July 2, 1990 FIFRA Enforcement
Response Policy (ERP) and is to be used in conjunction with the policies and matrices
found in that ERP.

      The EPA relies on data submitted by registrants as the basis for the Agency's
regulatory decisions involving pesticide product registrations, tolerances, experimental use
permits, special local needs registrations, emergency exemptions, or any other research or
marketing permit for a pesticide (hereafter referred to as "research or marketing
permits").  In conjunction with the EPA's data audit program, the FIFRA GLPs are
intended to ensure the quality and integrity of this data.

      Violations of the FIFRA GLPs may impact: (1) the reliability or scientific merits
of test data; (2) the ability of the EPA to validate or reconstruct test results; (3) the
ability of the Agency to make sound and timely regulatory decisions regarding a pesticide;
and, (4) the EPA's administration of the GLP inspection and enforcement program.
Therefore, noncompliance with the FIFRA GLP regulations may result in very serious
harm  to the EPA's regulatory mission and, ultimately, human health and the environment.

      Violations of the FIFRA GLPs may involve violations of FIFRA sections
12(a)(2)(B)(i),  12(a)(2)(M), 12(a)(2)(Q), or 12(a)(2)(R). Appropriate enforcement
responses for violations of the FIFRA GLPs include notices of warning, civil penalties of
up to  $5,000 per offense, and criminal penalties. In addition to these enforcement
responses, the EPA may  take regulatory action for violations of the GLPs, including:
rejection of studies which do not comply with the FIFRA GLPs; cancellation, suspension,
or modification of a pesticides research or marketing permit; or denial or disapproval of
an application for such a permit. Further, in order to help assure that the Federal
Government is dealing with responsible contractors, and for the purposes of the Federal
Government's protection, pesticide testing facilities responsible for significant or major
GLP violations may also be suspended or debarred from Government contracts or
subcontracts. To address these types of actions, this policy includes a section on referrals
to other EPA offices.

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                                        -2-
                    REQUIREMENTS OF THE FIFRA GLPS
      The FIFRA GLP standards, found at 40 CFR Part 160, prescribe the minimum
requirements that a pesticide testing facility (i.e., the laboratory, field site, etc.) and the
sponsor must fulfill in the following areas:

      1. Organization and personnel.
      2. Facilities.
      3. Equipment.
      4. Testing facilities operation.
      5. Test, control, and reference substances.
      6. Protocol for and conduct of a study.
      7. Records and reports.
Regulated Community	

      Any person, including a sponsor, pesticide testing facility, or registrant, who
conducts, initiates, or supports a study required by the Agency under FIFRA sections 3,
4, 5, 18, or 24(c), or sections 408 or 409 of the Federal Food, Drug,  and Cosmetic Act
(FFDCA).

Liability	'.	

      The EPA may pursue enforcement actions for violations of the FIFRA GLPS
against any of the persons listed above depending on the specific facts of the case.
Generally, the EPA will pursue separate civil administrative enforcement actions against
the study sponsor, applicant for the research or marketing permit, and the pesticide
testing facility since each of these parties have affirmative obligations to assure a study
complies with the GLP regulations. If the sponsor, applicant for the research or
marketing permit, or the pesticide testing facility are the same entity, the EPA will
generally pursue a single enforcement action against that single entity.  The  signers of the
GLP compliance statement may also be liable as individuals  if the compliance statement
required by 40 CFR 160.12 is false. However, in most cases, EPA will pursue
enforcement actions against the company for which  those individuals are employees or
Agents.                                                                   >

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                                         -3-


Studies Covered Under the FIFRA GLPs
       The FIFRA GLPs, as published in the Federal Register on November 29, 1983
(48 FR 53946), apply to all studies performed to determine the toxicity, metabolism, or
other effects in humans and domestic animals which were conducted, initiated, or
supported on or after May 2, 1984.1  The FIFRA GLPs, as amended (August 17, 1989;
54 FR 34052), also apply to all studies performed to determine the effects, metabolism,
product performance (with the exception of certain efficacy studies), environmental and
chemical fate, persistence and residue, or other characteristics in humans, other living
organisms, or media, conducted, initiated, or supported on or after October 16, 1989.1

       As per the scope of the GUP  regulations found at 40 CFR 160.1 and the definition
of a "research or marketing permit" found in 40 CFR  160.3,  the FIFRA GLP standards
apply to all studies as defined  above which are performed to support: (1) an application
for registration, amended registration, or re-registration of a pesticide product under
FIFRA sections 3, 4, or 24(c); (2) an application for an experimental use permit under
FIFRA section 5; (3) an application  for an emergency exemption under FIFRA
section 18; (4) a petition or other request for establishment or modification of a
tolerance, for an exemption for the need for a tolerance, or  for other clearance under
FFDCA section 408; (5) a petition or other request for establishment or modification of
a food additive regulation or other clearance by EPA  under FFDCA section 409; (6) a
submission of data in response to a notice issued by EPA under FIFRA section
3(c)(2)(B); or (7) any other application, petition, or submission sent to EPA intended to
persuade EPA to grant, modify, or leave unmodified a registration or other approval
required as a condition of sale  or distribution of a pesticide.
Violations	

      Violations of the FIFRA GLP Standards will be charged as unlawful acts of
FIFRA under sections 12(a)(2)(B)(i), 12(a)(2)(M), 12(aX2)(Q), or 12(a)(2)(R).  The
determination of the appropriate unlawful act to charge a violator will depend on the
specific facts of the case, based on the following guidance.
      The term "supported" includes studies which have been submitted to the EPA after the effective date of the
      GLP regulations. Therefore, studies which have been conducted or initiated before the effective date, but have
      been submitted to the EPA in support of a pesticide product research or marketing permit after the effective
      date, must be submitted with the GLP Compliance Statement required by 40 CFR 160.12.

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Violations of the GLPs Related .to a False GLP Compliance Statement -	
FIFRA §§ 12(a)(2)(M) and 12fa)(2)(Q)	

      Under 40 CFR 160.12, any person who submits to EPA data from a study which
falls under the scope of the GLPs must submit a statement, signed by the applicant of
the pesticide product research or marketing permit, the sponsor, and the study director,
that: (1) the study complies with the GLP requirements; (2) describes the differences
between the practices used in the  study and those required by the FIFRA GLPs; or
(3) the person was not the sponsor of the study, did not conduct the study,  and does not
know whether the study complies with the FIFRA GLP requirements.  If a study is
submitted to EPA with a GLP compliance statement which states that the study complies
with the GLP requirements, and GLP violations have occurred, then EPA will consider
that compliance statement to be false.  Similarly, if a study is submitted to EPA with a
GLP compliance statement which incorrectly describes the differences between  the
practices used in the study and those required by the GLPs, then EPA will  also consider
the compliance statement to be false.

      Submission of a false compliance statement is a violation of FIFRA  section
12(a)(2)(M) or FIFRA section 12(a)(2)(Q).  If the statement was knowingly falsified,
EPA may issue a civil penalty for  a violation of FIFRA section 12(a)(2)(M) or pursue a
criminal action.  Otherwise, submission of a false GLP compliance statement will be
pursued as a violation of FIFRA section 12(a)(2)(Q), as either a "high level," "middle
level," or "low level" GLP violation (see Appendix GLP-A for gravity levels and Appendix
GLP-B for guidance for determining whether to assess the violation as a high, middle, or
low level violation).

      Each independent violation of the GLP regulations which causes the GLP
compliance statement to be false may be assessed as a separate violation of either
FIFRA section 12(a)(2)(M) or 12(a)(2)(Q), as appropriate.  See the "Multiple
Violations" section of this ERP for a further discussion.  Also see the July 2, 1990 FIFRA
ERP, page 25, for a discussion of independently assessable charges.

Violations of the GLPs Not Related to the GLP Compliance Statement	

      Certain violations of the GLPs may result in an unlawful act under FIFRA
section 12 irrespective and independent of the truthfulness of the GLP compliance
statement required by 40 CFR Part 160.12.  These unlawful acts include FIFRA sections
12(a)(2)(B)(i); 12(a)(2)(M); 12(a)(2)(Q); and, 12(a)(2)(R).

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                                        -5-


FIFRA Section 12fa)(2^(B)(i)	

       Section 12(a)(2)(B)(i) of FIFRA states that it shall be unlawful for any person to
refuse  to prepare, maintain, or submit any records required under sections 5, 7, 8, 11, or
19. The FIFRA GLP records which registrants, applicants for registration, and producers
are required to maintain are, in part, required under the authority of FIFRA section 8.
Therefore, failure by a registrant, applicant for registration, or producer to prepare,
maintain, or submit any of the records required by the GLPs, including those required
under 40 CFR 169.2(k), may be charged as a violation of FIFRA section 12(a)(2)(B)(i).

       While almost all of the requirements under the GLPs provide in part for the
production and retention of certain records, violations by a registrant, applicant for
registration,  or producer of the requirements under 40 CFR Part 160.190 - Storage and
retrieval of records  and data, and Part 160.195 - Retention of records, are particularly
associated with recordkeeping and should be assessed as a violation of FIFRA section
12(a)(2)(B)(i).  However, in cases where the raw data or other records are retained, but
not according to the requirements in the GLP standards, unlawful acts under FIFRA
sections 12(a)(2)(M), 12(a)(2)(Q), or 12(a)(2)(R) should be charged, rather than FIFRA
section 12(a)(2)(B)(i).

       Because FIFRA section 8 does not currently authorize EPA to require pesticide
testing facilities to maintain records, recordkeeping violations by a pesticide testing
facility should not be assessed as a violation of FIFRA section 12(a)(2)(B)(i), unless the
study is being submitted under FIFRA section 5 for an experimental use permit, or  under
section 19.  Instead, most GLP related recordkeeping or reporting violations by a
pesticide testing facility will be charged through enforcement  of the  truthfulness of the
GLP compliance statement [FIFRA sections 12(a)(2)(M) or 12(a)(2)(Q)] or through
FIFRA section  12(a)(2)(R).

       An unlawful  act under FIFRA section 12(a)(2)(M),  12(a)(2)(Q), or 12(a)(2)(R)
may be charged in addition to the recordkeeping violation  charged under FIFRA section
12(a)(2)(B)(i), if the recordkeeping violation also results in the submission of a false GLP
compliance statement [§§12(a)(2)(M) or 12(a)(2)(Q)] or the knowing submission of false
data [§12(a)(2)(R)J. The EPA considers these unlawful acts to be independently
assessable because it is possible to be in violation of the recordkeeping requirements of
the GLPs and still submit a true and correct GLP compliance statement which indicates
that the required records have not been maintained.  It is also possible to maintain the
required records, and therefore comply with section 12(a)(2)(B)(i), but to have
maintained false records or to knowingly submit false data to the Agency.

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FIFRA Section
      Section 12(a)(2)(M) of FIFRA states that it shall be unlawful for any person to
knowingly falsify 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 any provision of the Act.
Compliance with the GLPs is required as part of an application for registration or an
application for an  experimental use permit, and GLP compliance entails the maintenance
of records (personnel records, Quality Assurance Unit (QAU) records and reports to
management, etc.) and filing of reports (final study reports, including the submission of a
GLP compliance statement, QAU reports, etc.).  "Knowing falsification" of the GLP records
or reports as related to these provisions constitutes a violation of FIFRA section 12(a)(2)(M).

FIFRA Section
      Section 12(a)(2)(Q) of FIFRA states that it is unlawful for any person to falsify
all or part of any information relating to the testing  of any pesticide (or any of its
ingredients, metabolites, or degradation products) 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.

      Regardless of the truthfulness of the GLP compliance statement, through this
unlawful act, EPA may pursue an enforcement action for a violation of any requirement
of the GLPs which involves the falsification of testing information which was submitted to
the EPA, or for which a testing facility  or sponsor knows will eventually be submitted to
the Agency, or will be required to be maintained as  a record under the GLPs or 40 CFR
Part 169. The EPA is not required to assert that the falsification was "knowing," only
that the information was "false".

      Additionally, under this unlawful act, EPA may pursue an enforcement action for
a GLP violation for an ongoing study for which no final report has  been submitted to the
Administrator and for which no compliance statement under 40 CFR 160.12 has yet been
signed, provided the EPA can  document that information which was required to be
documented as the study proceeded was false, and the pesticide testing facility knew that
the information was being generated with the intention of being submitted to the EPA
(note the requirement in 40 CFR 160.10).2  The language of FIFRA section 12(a)(2)(Q)
provides this authority since the unlawful act applies to the falsification of information
relating to the testing of a pesticide "...  that the person knows will be furnished to the
Administrator or will become a part of any records required to be maintained by this Act."
1     The appropriate enforcement response for GLP violations in on-going studies will generally be a notice of
      warning (NOW), unless the violation involves a "knowing" violation. Further, if the violation for which an NOW
      was issued is not corrected by the time the study is submitted to the Agency, the EPA will pursue a civil or
      criminal action.

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                                        -7-


FIFRA Section 12(aX2)(R)	

       Section 12(a)(2)(R) of FIFRA states that it is a violation of FIFRA to submit data
known to be false in support of a registration. Studies required under FIFRA sections 3,
4, and 24(c) are clearly required to support a pesticide registration.  Additionally, studies
conducted under FIFRA section 5 and 18 may be used to support a pesticide product
registration at some time.  Therefore, knowing submission of false data, including false
records/reports required under the FIFRA GLPs will constitute a violation of this provision
of FIFRA.  Unlike FIFRA section 12(a)(2)(Q), the applicability of this unlawful act is
dependent on a finding that the data submitted was "known" to be false by the violator.

Multiple Violations	

       A statement, under 40 CFR 160.12, which certifies that a study complies with the
GLPs is a statement that all requirements listed  in 40 CFR Part 160 have been met. If
requirements of the GLPs have not been met, then the GLP compliance statement is
false. Each independent requirement of the GLPs which has been violated, but has been
represented through the statement as in compliance, may be considered a separate count
of FIFRA section 12(a)(2)(M) or 12(a)(2)(Q), as appropriate, and each count assessed a
civil penalty up to the statutory maximum (see the July 2, 1990 FIFRA ERP, page 25,  for
a discussion of independently assessable charges).  For example, a sponsor could be
assessed a civil  penalty for up to $15,000 because that sponsor submitted a study with a
GLP compliance statement which failed to truthfully state that the pesticide testing
facility: (1) failed to maintain personnel records; (2) failed to designate a study director;
and, (3) failed to record raw data.

       Unlawful acts under FIFRA sections 12(a)(2)(B)(i);  12(a)(2)(M); 12(a)(2)(Q);
and, 12(a)(2)(R) may be assessed in addition to  those violations assessed as a false
compliance statement, provided that these additional unlawful acts are independent of
the counts charged as a falsification of the GLP  compliance statement.

       Generally, GLP violations will be assessed on a per study basis. Therefore,
multiple violations of the same requirement in separate studies will be considered as
separate offenses.  These violations are independent violations, and therefore, each
violation should be assessed a separate civil penalty of up to the statutory maximum.
However, as a matter of policy, multiple violations of the same GLP requirement in a
single study will not be assessed as separate offense each time the specific requirement is
violated in that study.  Rather, multiple violations of the same requirement in a single
study will be considered as a single offense which may be raised from a low level to a
middle level, or a middle level to a high level GLP violation, depending on the
significance and frequency of the violation in a single study (see Appendix GLP-B-2).
The Agency has taken this approach for this ERP because  many of the GLP
requirements which require repetitious compliance throughout the life of the study (such
as failing to initial data entries (40 CFR 160.130(e)), can occur unchecked in a single
study for an undefined period of time, and penalties for violations of a single repetitive
requirement could accumulate to inappropriate or unrealistic levels.

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                               LEVELS OF ACTION
      The levels of enforcement action for violations of the FIFRA GLPs include
notices of warning, administrative civil penalties, and criminal proceedings. Additionally,
in accordance with the July 2, 1990 FIFRA ERP, press releases should be issued in
conjunction with most enforcement responses (except notices of warning).
Notices of Warning (NOW')	

       Notices of Warning (NOW) are the appropriate enforcement response in the
following circumstances:

       o     First-time violations by an independent pesticide testing facility which has
             been contracted by a study sponsor to conduct testing which falls under the
             scope of the GLPs.3  Under FIFRA section 14, any person not listed in
             section 14(a)(l), who is not a "for-hire applicator", may only receive a civil
             penalty subsequent to receiving a written notice of warning from the
             Administrator (see page 4 of the July 2, 1990 FIFRA ERP).  Pesticide
             testing facilities are not included under FIFRA section 14(a)(l) and,
             therefore, fall  under the category of persons under FIFRA section 14(a)(2)
             who must receive an NOW prior to being assessed a civil penalty for
             violations of FIFRA.

       o     First-time 'low level" GLP violations assessed as violations of FIFRA
             section 12(a)(2)(Q) (see Appendix GLP-B).
      Pesticide testing facilities which are owned'or operated by the registrant may be charged a civil penalty of up to
      $5,000 per offense for the first violation of the GLPs under FIFRA section 14(a)(l).

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                                          -9-
       o      GLP violations assessed as violations of FIFRA sections 12(a)(2)(B)(i), or
              12(a)(2)(R) which are clerical or technical violations which either
              separately or collectively have a relatively minor impact on: (1) the
              reliability or scientific merits of the test data; (2) the Agency's ability to
              make a regulatory decision regarding a pesticide product's registration or
              other research or marketing permit; (3) the ability of the Agency to be able
              to validate  the test results or reconstruct the study; and, (4) the EPA's
              administration of the GLP inspection and enforcement program (i.e.,
              impairment of the Agency's inspection targeting ability or the efficiency of
              the GLP compliance inspections or data audits, etc.)/

       o      Falsification of records required to be maintained in an ongoing study  for
              which no final report has been submitted to the Administrator and for
              which no compliance statement under 40 CFR 160.12  has yet been signed.

       Generally, a notice of warning will not be appropriate if  the violator has
previously violated the GLP regulations (criteria for establishing "compliance history" may
be found in the July 2, 1990 FIFRA ERP, Appendix B, page B-3, footnote number 4)  or
the violator has received  a notice of warning for a previous GLP related  violation.
Civil Administrative Penalties	

       Civil penalties assessed for violations of the FIFRA GLPs are to be calculated
according to the procedures and matrices provided in the July 2, 1990 FIFRA
Enforcement Response Policy.  The gravity levels established for each violation on the
FIFRA GLPs are listed in Appendix GLP-A of this ERP and in Appendix A of the
July 2, 1990 FIFRA ERP.

       Civil penalties may be assessed against both the study sponsor and the pesticide
testing facility.  A registrant (usually the study sponsor),  or pesticide  testing facility owned
by a registrant, will be assessed civil penalties of up to $5,000 per offense under FIFRA
section 14(a)(l). An independent pesticide testing facility who was contracted by the
study sponsor will be assessed civil penalties of up to $1,000 per offense, subsequent to a
written notice of warning, under section 14(a)(2).
       An example of a clerical or technical violation which has a relatively minor impact on the criteria listed above is
       a one-time failure to fulfill one of the GLP repetitive requirements, such as, failure to sign or initial, and date a
       data entry [160.130(e)].  Another example is a transcription error which can be verified or corrected by other
       means and which did not result in an erroneous conclusion for the overall study.

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                                        -10-
      A civil administrative penalty will be issued for all violations of the FIFRA GLPs
which do not qualify for a notice of warning and have an impact on: (1) the reliability or
scientific merits of the test data; (2) the Agency's ability to make a regulatory decision
regarding a pesticide product's registration or other research or marketing permit; (3) the
ability of the Agency to be able to validate the test results, i.e., reconstruct study, verify
results; or, (4) the EPA's administration of the GLP inspection and enforcement program
(i.e., targeting of inspections, delay in an the Agency's inspection  activities or data  audit
because standard GLP procedures or formats are not followed, etc.). In addition,  a civil
administrative penalty will be issued for repeat violations of the GLP regulations.

      Most violations of FIFRA GLP Standards are considered as recordkeeping or
reporting violations.  As noted in the July 2, 1990 FIFRA ERP, 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
of the July 2, 1990 FIFRA ERP. Therefore, first-time civil penalties are to be assessed
at the matrix value, while subsequent civil penalties should be increased by an increment
of 30% (up to the statutory  maximum). Please note, repeat violations of the identical
GLP requirement may indicate a "knowing or willful" violation, and therefore, the  need
to pursue criminal proceedings.
Criminal Proceedings	

      Criminal proceedings may be initiated against an applicant for registration, or
study sponsor who is a registrant, applicant for registration, or pesticide producer, for
knowing and willful violations of the FIFRA GLPs, under FIFRA section 14(b)(l)(A) for
criminal penalties of up to $50,000 and/or imprisonment for up to one year.  Any
commercial applicator of a restricted use pesticide, or any person not described in
FIFRA  section 14(b)(l)(A) who distributes or sells pesticides or devices, who knowingly
violates any provision of FIFRA shall be fined up to $25,000 and/or imprisoned for up to
one year. The EPA may also pursue criminal proceedings against the pesticide testing
facility,  or other person for knowing and willful violations of the GLPs under FIFRA
section  14(b)(2) for criminal penalties of up to $1,000 and/or imprisonment for up to 30
days. Additionally, criminal proceedings may be pursued against the registrant, pesticide
testing facility, or other person for violating Title 18 of the U.S. Code.

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                                        -11-
                                   REFERRALS
       In addition to the levels of enforcement action listed in the previous section, the
EPA may take regulatory action for violations of the GLPs, including: rejection of studies
which do not comply with the FIFRA GLPs; cancellation, suspension, or modification of
a pesticides research or marketing permit; or denial or disapproval of an application for
such a permit.  Further, in order to help assure that the Federal Government deals with
responsible contractors, and for the purposes of the Federal Government's protection,
pesticide testing facilities responsible for significant or major GLP violations may also be
suspended or debarred from Government contracts or subcontracts. Until further
guidance is issued, the Agency's regulatory response for violations of the GLPs will be
addressed on a case-by-case basis and, therefore, will not be addressed in detail  in this
policy.
Office of Pesticide Programs	

      If the Agency discovers any significant or major GLP violations or data concerns
in the course of a facility inspection or study audit, the Office of Compliance Monitoring
will notify the Office of Pesticide Programs so that Office may consider if any regulatory
action would be appropriate.  These regulatory actions include:  (1) rejection of studies
which do not comply with the FIFRA GLPs; (2) cancellation, suspension, or modification
of a pesticide's  research or marketing permit; or, (3) denial or disapproval of an
application for  such a permit.

      Pursuit of an enforcement action by the EPA, such as the issuance of a civil or
criminal complaint, does not obligate the Agency to pursue a regulatory response, such as
study rejection  or cancellation/suspension of a pesticides research or marketing permit.
Similarly, a regulatory response by the Agency does not obligate the Agency to pursue an
enforcement action.  The EPA's decision to pursue an enforcement response and/or
regulatory response to a GLP violation will, by administrative necessity, occur on
different tracks and will be based on the individual merits of each approach on a case-by-
case basis.

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                                       -12-
Office of Administration
      Pesticide testing facilities responsible for significant or major GLP violations may
be suspended or debarred from Government contracts, subcontracts, and assistance loan
and benefit programs.  This action is not for the punishment of the violator nor is it an
enforcement tool, but rather it is for the protection of the Federal Government by
assuring that the Government will be dealing with responsible contractors.

      The Office of Compliance Monitoring will notify the Compliance Branch of the
Grants and Administration Division, Office of Administration of the identity of pesticide
testing facilities which are responsible for a significant or major GLP violation and
have been assessed a civil penalty through a final order or when there is evidence of a
criminal offense for violations of the FIFRA GLPs, so that Office may decide whether
they wish to pursue suspension or debarment proceedings in accordance with the Federal
Acquisition Regulations (FAR) at 48 CFR Subpart 9.4, and the EPA Suspension and
Debarment regulations found at 40 CFR Part 32.

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               APPENDIX GLP - A
       FIFRA CHARGES AND GRAVITY LEVELS
FOR CIVIL PENALTIES ASSESSED FOR VIOLATIONS OF THE
   FIFRA GOOD LABORATORY PRACTICE STANDARDS

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                                         GLP-A-1

                                      APPENDIX GLP-A
                          FIFRA CHARGES AND GRAVITY LEVELS
 FIFRA
SECTION
FTTS
CODE
VIOLATION
LEVEL
                    2BA    Person refused to PREPARE, MAINTAIN, or SUBMIT
                            any RECORDS required under sections 5, 7, 8, 11
                            or 19.
12(a)(2)(M)
12(a)(2)(Q)
!2(a)(2)(Q)
 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 Gled under the Act, or any
          information marked as confidential and submitted to
          the Administrator under any provision of 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.
12(a)(2)(Q)
 2QC   Person falsely represented compliance with the FIFRA
         Good Laboratory Practice (GLP) regulations as a result
         of a MIDDLE LEVEL GLP* violation.
!2(a)(2)(Q)
 2QD    14(a)(l) person falsely represented compliance with
          the FIFRA Good Laboratory Practice (GLP) regulations
          as a result of a LOW LEVEL GLP* violation.
!2(a)(2)(Q)
 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.
!2(a)(2)(R)
 2RA   Person submitted DATA KNOWN TO BE FALSE in
         support of a registration.
        Guidance on the parameters for determining whether a GLP violation assessed as an unlawful act under FIFRA
        section 12(a)(2)(Q) is a HIGH, MIDDLE, or LOW LEVEL violation is found in Appendix GLP-B.

        A higher level has been assigned for FIFRA section 14{a)(2) persons because a civil penalty which is assessed
        under this provision represents the second violation of that person. Violators who fall under the category of
        persons listed in FIFRA section  14(a)(2) must receive a Notice of Warning for the first GLP violation.

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                      APPENDIX GLP - B
GUIDANCE FOR DETERMINING WHETHER TO ASSESS A GLP VIOLATION
             UNDER FIFRA SECTION 12(a)(2)(Q) AS A
           HIGH, MIDDLE, OR LOW LEVEL VIOLATION

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                                    GLP-B-1
                               APPENDIX GLP-B
 GUIDANCE FOR DETERMINING WHETHER TO ASSESS A GLP VIOLATION
                   UNDER FIFRA SECTION 12(a)(2)(Q) AS A
                 HIGH, MIDDLE, OR LOW LEVEL VIOLATION
      When assessing a civil penalty for violations of FEFRA section 12(a)(2)(Q) for
submission of a false compliance statement (FTTS codes 2QB, 2QC, 2QD, and 2QE, as
listed in Appendix GLP-A of this ERP and Appendix A of the July 2, 1990 FIFRA
ERP), the parameters listed in this appendix will be used to determine whether a GLP
violation is a "high", "middle", or "low level" GLP violation. Because of the expertise that
is necessary to make an assessment of the impact of a GLP violation, the determination
of whether a violation will be considered as a high, middle, or low level will be made at
EPA Headquarters by the Office of Compliance Monitoring with input from the  Office
of Pesticide Programs and the Office of Enforcement based on the criteria listed in this
appendix.  A brief summary of the rationale for the categorization of the impact  of the
GLP violation should be included as part of the civil complaint sent to the respondent.
High Level GLP Violations	

      A "high level" violation of the FIFRA GLPs involves a substantial failure to
comply with the regulations.  "High level" GLP violations will have a substantial impact
on: (1) the reliability or scientific merits of the test data; (2) the Agency's ability to
make a  regulatory decision regarding a pesticide product's registration or other research
or marketing permit; (3) the ability of the Agency to be able to validate the test results,
i.e., reconstruct the study, verify results; or (4) the EPA's administration of the GLP
inspection and enforcement program (i.e., impairment of the Agency's inspection
targeting ability or the efficiency of the GLP compliance inspections or data audits, etc.).
Violations which will be considered as "high level" based on the above criteria include,
but are not limited to:

      1)    Failure to notify a person performing under contract of
            the applicability of GLPs - §160.10.
      2)    Failure to keep personnel records - §160.29.
      3)    Falsification of personnel records - §160.29.
      4)    Failure to designate a study director - §160.31.
      5)    Failure to assure the existence of a Quality Assurance
            Unit (QAU) - §160.31.
      6)    Failure of the QAU to conduct any inspections or maintain
            any records - §160.31.

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                                      GLP-B-2
       7)     Failure to maintain Standard Operating Procedures -
             §160.81.
       8)     Failure to follow laboratory SOPs without
             documentation in the raw data and/or written
             authorization from management - §160.81(a).
       9)     Failure to isolate all newly received animals
             from outside sources until their health status
             has been evaluated - §160.90(b).
       10)    Failure to characterize the test, control, or reference
             substances - §160.105.
       11)    Failure to have a protocol - §160.120.
       12)    Deviation from the protocol without documentation
             and/or study director written signoff - §160.120(b).
       13)    Failure to record raw data - §160.130.
       14)    Falsification of raw data - §160.130.
       15)    Failure to retain raw data and specimens - §160.51,
             §160.190, and  §160.195.

       Partial compliance  with a "high level" GLP violation, such as the examples listed
above, may justify considering the violations as "middle level" GLP violations.
Middle Level GLP Violations	

      All violations of GLPs which are not considered "high level" violations are
considered to be "middle level" GLP violations UNLESS the violation is determined to
be a "low level" violation (see the subsequent section for the criteria for determining a
"low level" violation).

      Partial compliance with any of the violations which could be  considered as a "high
level" GLP violation (such as the violations listed in the "High Level GLP Violation"
section above), may qualify for consideration as a "middle level" GLP violation.  For
example, a pesticide testing facility may be charged a "middle level" GLP violation rather
than a "high level" GLP violation for failure to maintain personnel records, provided that
the personnel records for that facility are mostly complete.

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                                      GLP-B-3
Low Level GLP Violations
      A GLP violation will be considered "low level" in cases where the violative act was
purely clerical or technical in nature with relatively minor impacts on: (1) the reliability
or scientific merits of the test data; (2) the Agency's ability to make a regulatory decision
regarding a pesticide product's registration or other research or marketing permit; (3) the
ability of the  Agency to be able to validate the test results, i.e., reconstruct the study,
verify results; or, (4) the EPA's administration of the GLP inspection and enforcement
program (i.e., targeting of inspections, delay in the Agency's inspection or data audit
activities because standard GLP procedures  or formats are not followed, etc.). "Low
level" violations  are appropriate where there is a general program in place by a violator
to comply with the GLPs, but instances of noncompliance  occur anyway due to apparent
inadvertent error, equipment failures, or other similar occurrences.  Violations which will
be considered as "low level" based on the above criteria include, but are not limited to:

      1)     A  facility generally maintained a current summary of
             training and experience and job description for each
             individual engaged in the study but failed to do so
             for one or two individuals - §160.29(b).
      2)     A  facility generally maintained records which documented
             equipment inspection, maintenance, testing, calibrating,
             and/or standardizing operations, but failed to document
             these operations in one instance -  §160.63(c).
      3)     A  facility maintained all revisions to the standard
             operating procedures (SOPs) but failed to note the date
             of the revision in one or two instances - §160.81(d).
      4)     A  reagent or solution which is documented not to degrade
             does not have an expiration date on the label - §160.83.
      5)     One-time failure to fulfill one  of the GLPs repetitive
             requirements, such as failure to sign or initial, and date
             a data entry - §160.130(e).
      6)     A  clerical error or transposition of numbers  in the final
             study report which can be verified or corrected by other
             means and which did not result in an erroneous conclusion
             for the overall study - §160.185 or §160.195.

      If the  EPA believes that justice may be served, EPA may issue a Notice of
Warning under FIFRA section 9(c)(3) for first-time "low level" GLP violations. However,
subsequent "low level" violations will result in the assessment of a level 4 civil penalty for
a FIFRA section 14(a)(l) violator and a level 3 civil penalty for a FIFRA section
14(a)(2) violator.

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                                          Index

The documents in this index are referenced by the Compendium subject/volume abbreviation and the date
of the document.  However, FIFRA Compliance Program Policy Compendium documents are referenced
by the subject/volume abbreviation and the document number. The abbreviations for the subject/volumes
in this index are as follows:

              TG - Technical Guidance (Volume 1);
              SRG - State-Related Guidance (Volume 2);
              ES - Enforcement Strategies (Volume 3);
              ERP - Enforcement Response Policies (Volume 4); and
              FCPP - FIFRA Compliance Program Policy Compendium (Volume 5)
Agricultural use only, FCPP 25.1
Alar. See Daminozide
Aldicarb
     stop sale, ES 04-30-90
Aldrin, TG 02-00-90
Aluminum Phosphide products, FCPP 3.3
Amitraz, TG 02-00-90
Antifouling paints, ES 04-21-83
Antimicrobial pesticide, TG 05-28-86
Application review procedures, SRG 06-13-89
Arsenic Trioxide, ES 06-06-89, TG 02-00-90
Basic registrations, FCPP 3.9
Benomyl, TG 02-00-90
BHC, TG 02-00-90
Bithionol, TG 02-00-90
Books and records. See Recordkeeping and reporting
Bromoxynil, TG 02-00-90
     conditional registration and cancellation of certain
     products, ES 07-06-89
Bromoxynil Butyrate, TG 02-00-90
Bulk shipments, TG 07-11-77
Cadmium, TG 02-00-90
Calcium Arsenate.  See Wood Preservatives
Cancellation order,  TG 08-21-90
Captafol, TG  02-00-90
Captan, TG 02-00-90
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Carbon Tetrachloride, TG 02-00-90
     cancellation, ES 07-11-87
Cedar Chemical Company, ES 06-15-88
Certification plan, FCPP 26.1
Certified applicators, TG 11-29-83, TG 04-25-84, FCPP 2.3,
 FCPP 12.4
Chemigation, FCPP 12.7
Child-resistant packaging, ES 06-08-81, FCPP 25.1
Chloranil, TG 02-00-90
Chlordane/heptachlor, TG 02-00-90
     corn use, ES 08-27-76
     suspension, ES 01-15-76, ES 01-22-76, ES 02-19-76,
     ES 11-23-76
           enforcement strategy, ES 3-23-76
     termiticides
           cancellation and suspension, ES 04-13-88
           revised compliance strategy, ES 04-13-88
Chlordimeform, TG 02-00-90
     cancellation strategy, ES 06-19-89
     existing stocks, ES 02-09-89, ES 06-19-89
     recall, ES 06-19-89
Chlorobenzilate, TG 02-00-90
Civil compliance,  TG 01-16-80
Civil liability, TG 10-22-81
Civil penalties, TG 07-12-79, SRG 02-24-81
Civil penalty
     assessment, TG 01-17-80
     calculation, ERP 07-02-90
     matrix, ERP 02-10-86
Commercial applicator, FCPP 2.3
Communications strategy
     FIFRA and TSCA GLPs, ES 04-25-90
Compliance monitoring inspection, ES 06-15-88
Compound 1080, ES 07-25-86, TG 02-00-90
Confidentiality, FCPP 10.1
Conservation Reserve Program (CRP), FCPP 3.7
Contract manufacturing, FCPP 3.2
Cooperative agreement, SRG 07-31-89, FCPP 26.1
     application requirements, SRG 06-13-89
     funds, SRG 06-13-89
     implementation, ES 11-22-83
Copper Arsenate, TG 02-00-90
Credentials, SRG  12-18-80
Creosote, ES 10-23-86, TG 02-00-90
Criminal penalties, TG 07-12-79
Crop rotation restrictions, FCPP 3.7
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Cropland, FCPP 3.7
Custom blenders, FCPP 3.4, FCPP 7.1
Cyanazine, TG 02-00-90
Cyhexatin, TG 02-00-90
Daminozide (Alar), TG 02-00-90
     agreement to halt sales, ES 06-14-89
     final compliance monitoring strategy, ES 10-20-86
Data call-in requirements, ES 09-13-85
DBCP, TG 02-00-90
     suspension order, ES 11-07-79
DDD (TDE), TG 02-00-90
Dealer, FCPP 12.4
Dealer/distributor, ES 02-09-89
Diallate, TG 02-00-90
Dibromochloropropane. See DBCP
Dicofol, TG 02-00-90
Dieldrin. See Aldrin
Diluent, FCPP 12.5
Dimethoate, TG 02-00-90
Dinoseb, TG 02-00-90, ES  04-17-87, ES 03-14-88, ES 06-15-88
     amendment to suspension, ES 04-02-87
     cancellation, ES  03-28-88, ES 06-15-88, ES 03-03-89
     emergency suspension, ES 10-07-86
     exemption requirements, ES 04-02-87
     stipulated order,  ES 03-28-88
     suspension order, 04-17-87
Direct supervision, FCPP 2.3
Disinfectants, TG 02-00-90
Distributor registrations,  FCPP 3.2
District court injunction,  ES 03-28-88
Drinking water, TG 08-30-75, ES 10-00-80
EBDC, TG 02-00-90
     compliance strategy, ES 03-12-90(a), ES 03-12-90(b)
EDB, TG 02-00-90
     grain uses, ES 02-03-84, ES 02-06-84(a), ES 02-06-84(b)
     soil fumigation use, ES 10-06-83
     suspension, ES 10-06-83, ES 02-03-84, 02-06-84(a)
Electronic mosquito repelling devices, TG 02-00-90
Emergency exemptions, ES 03-14-88
Enclosed cabs, TG 02-00-90, FCPP 12.6
Endangered species, TG 02-01-88, SRG 06-13-89, SRG 07-31-89
Endrin, TG 02-00-90
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Enforcement, FCPP 12.7
Enforcement actions, TG 08-30-75, TG 12-19-79
Enforcement responsibility, primary. See Primacy
Engineering controls, FCPP 12.6
EPN, TG 02-00-90
Establish competency, FCPP 4.1
Establishment registration, ERP 02-10-86, FCPP 3.5, FCPP 7.1,
 FCPP 10.1
Ethylene bisdithiocarbamate. See EBDC
Ethylene dibromide. See EDB
Evidence, FCPP 26.1
Executive agencies, TG 01-16-80
Exemptions, FCPP 3.1
Experimental use permit (EUP), FCPP 12.1
Exporting
     unregistered pesticides, TG 07-28-80
Existing stocks, TG 08-21-90
     chlordimeform, ES 02-09-89, ES 06-19-89
Exports.  See Imports and exports
Federal facilities, TG 01-16-80
Fertilizer
     pesticide mixture(s), FCPP 2.1, FCPP 3.4
Financial status, TG 10-17-80
Fish and Wildlife Service (FWS), ES 07-25-80
Fluoroacetamide, TG 02-00-90
Foreign trade zones, FCPP 17.1
Form 10-K. See 10-K Statements
Free ports, FCPP 17.1
Fumigants, ES 04-21-83
Fumigation, FCPP 3.3
Good Laboratory Practices (GLPs)
     and data audits, ES 11-22-83, ES 01-15-85
     notification plan, ES 04-25-90
     question and answer document, TG 05-12-92
Good Laboratory Practice (GLP) Standards
     agreement
           interagency; Department of Health and Human Services,
           National Toxicology Program, ES 01-15-85
           memorandum of; for conduct of laboratory inspections and
           data  audits, ES 01-15-85
     equipment, ES 11-29-83, ES 01-15-85
     inspections,  ES 01-15-85

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Good Laboratory Practice (GLP) Standards (continued)
     organization and personnel, ES 11-29-83, ES 01-15-85
     quality assurance unit, TG 08-17-89
     records and reports, ES 11-29-83, TG 08-17-89, ES 01-15-85
     regulations, ES 01-15-85
     standard operating procedures, TG 08-17-89
     testing, ES 11-29-83, 01-15-85
     testing facilities, ES 11-29-83, ES 01-15-85, TG 08-17-89
Government agency
     state or local, SRG 02-24-81
Grain uses
     EDB,  ES 02-03-84, ES 02-06-84(a), ES 02-06-84(b)
Grant application forms, SRG 06-13-89
Ground water, SRG 07-31-89,  SRG 06-13-89
Heptachlor. See Chlordane/heptachlor
HTLV-III/LAV, TG 05-28-86
Imports, FCPP 17.2
     and exports, TG 11-19-76
Indemnification claims, ES 10-06-83
Inorganic arsenicals, ES 10-23-86, ES 06-06-89
Inspections, FCPP 12.3
     establishment, TG 01-24-77
     Good Laboratory Practice Standards, ES 01-15-85
     labeling, ES 04-21-83
     pesticide use, TG 01-24-77, SRG 12-18-80
Intrastate use, FCPP 24.1
Kepone, TG 02-00-90
Knowledge expert, FCPP 2.1
Label Improvement Program (LIP), ES 04-21-83
Labeling, TG 10-22-81, TG 05-28-86, TG 02-00-90, SRG 09-01-92, FCPP 2.2,
     FCPP 3.3, FCPP 24.1, FCPP 25.1
     changes, TG 02-21-88
     requirements for exported pesticides, devices, and pesticide
      active ingredients, TG 07-28-80
Lead Arsenate.  See Wood Preservatives
Level of action, ERP 07-02-90
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Lindane, TG 02-00-90
     compliance monitoring strategy, ES 04-25-85
     notice of intent to cancel, ES 07-10-86
LIP Notice. See Label Improvement Program
Livestock protection (LP) collars, ES 07-25-86
Love v. Thomas, ES 03-28-88
Low volume applications, FCPP 12.5
Maintenance fees
     registration, TG 08-21-90
Make available for use, FCPP 12.4
Manufacturing use only, FCPP 3.8
Mercury, TG 02-00-90
     cancellation,  ES 10-28-76
     settlement, ES 01-06-77
     biocides, registration, ES 09-12-90
     phenylmercuric acetate, cancellation, ES 09-12-90
Methyl Bromide
     California Fact Sheet, FCPP  3.10
     Label Revision, SRG 09-01-92
Metaldehyde, TG 02-00-90
Mirex, TG 02-00-90
Misuse, FCPP 2.1, FCPP 12.3, FCPP 26.2
Monocrotophos, TG 02-00-90
Multi-use products, FCPP 17.2
OMPA, TG 02-00-90
Oxyfluorfen, TG 02-00-90
Neutral administrative inspection scheme, ES 09-03-85
NOIC, ES 06-15-88
Noncertified applicator, FCPP 2.3
Noncropland, FCPP 3.7
Notice of arrival, FCPP 17.2
Notice of intent to suspend (NOTTS), ES 09-03-85
Outer containers, FCPP 2.2
Parathion, TG 02-00-90
PCBs, TG 02-00-90
PCNB, TG 02-00-90
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Penalties
     civil. See Civil penalties
     criminal. See Criminal penalties
Pentachlorophenol.  (See also Wood Preservatives), ES 10-23-80
PEPS (Pesticide Enforcement Policy Statements), TG 04-01-76,
 TG 07-08-76, TG 06-08-79
     institution of, TG 05-05-75
Permissible Exposure Limitation (PEL) Program, ES 10-23-86
Personal protective equipment, FCPP 12.2, FCPP  12.6
Personal use, FCPP  3.8
Pest control
     devices, TG  11-19-76
          electromagnetic, TG 02-00-90
          nonhazardous, TG 12-19-79
          preventive, TG 07-08-76
     nonstructural, TG 06-08-79
     structural, TG 06-08-79
Pesticide
     cancellation,  TG 02-00-90
     restricted use, TG 02-00-90
     suspension, TG 02-00-90
Pesticide dealer, FCPP 2.3
Pesticide Enforcement Policy Statements.  See PEPS
Pesticide use
     at less than label dosage rate, TG 06-08-79
     by veterinarians, TG 11-01-79
     control of pests not named on the label, TG 06-08-79 (See
      also Pest control - nonstructural)
          control of unnamed target pests, TG 06-08-79
     enforcement, TG 01-24-77
     uses which do not appear on label, advocacy of, TG 10-22-81,
      TG 05-28-86
Phenarsazine Chloride, TG 02-00-90
Phosphine gas, FCPP 3.3
Polychlorinated Biphenyls. See PCBs
Polychlorinated Terphenyls, TG 02-00-90
PR Notice 87-1, FCPP 12.7
Primacy, SRG 05-11-81, SRG 01-05-83, SRG 10-02-85, FCPP 26.1,
 FCPP 26.2
     rescission of, ES 11-22-83
Private applicator, SRG 02-24-81, FCPP 2.3
     certification,  FCPP 4.1
Processing, FCPP 17.1
Producer, ERP 02-10-86
Product labeling, ES 04-21-83
Product registration, FCPP 3.5, FCPP 3.8

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Production data, FCPP 10.1
Program oversight
     evaluation and reporting, SRG 06-13-89
Pronamide, TG 02-00-90
Purifiers. See water purification devices
Quaternary Ammonium Compounds, TG 02-00-90
Rail cars, FCPP 3.3
Recall
     chlordimeform, ES 06-19-89
     dinoseb, ES 03-14-88
Recordkeeping and reporting, TG 11-19-76, TG 11-29-83,
 TG 04-25-84
Referrals, SRG 10-02-85
Registered use pesticides, TG 11-01-79, SRG 02-24-81
Registrant
     reporting requirements, TG 08-23-78
Registrant/distributor liability, FCPP 3.9
Registration, FCPP 3.4, FCPP 17.1
     of establishments, TG 11-19-76
Repackaging, FCPP 3.2, FCPP 17.1
Reporting. See also Recordkeeping and reporting, ERP 02-10-86,
 FCPP 7.1
Reporting requirements
     study and experimental data, TG 07-12-79
Request procedures
     large numbers of samples or investigations, TG 07-30-80
     procedures complaint followup, TG 07-30-80
     sample or label, TG 07-30-80
Rescission proceedings, SRG 05-11-81
Respirators, FCPP 12.6
Restricted use pesticides (RUP), TG 02-00-90, FCPP 12.4
Rhone-Poulenc, ES 07-06-89, ES 04-30-90
Safrole, TG 02-00-90
Salt water emesis, ES 04-21-83
Seed treatments, TG 02-00-90
Shipment, FCPP 3.1
Shipping containers, FCPP 2.2
Silvex.  See 2,4,5-T and Silvex
Sodium Arsenate.  See Wood Preservatives
Sodium Arsenite.  See Wood Preservatives
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Sodium Cyanide, TG 02-00-90
Sodium Fluoride, TG 02-00-90
Sodium Monofluoroacetate. See Compound 1080
Soil fumigation use
     EDB, ES 10-06-83
Special local need, FCPP 24.1
Special packaging. See Child-resistant packaging
Spot fumigation, ES 02-06-84(a), ES 02-06-84(b)
Spot treatment, FCPP 3.7
State authority, FCPP 26.1, FCPP 26.2
Stop Sale, Use, or Removal Order, TG 12-19-79, TG 08-21-90,
 ES 09-03-85,
     aldicarb, ES 04-30-90
     dinoseb, ES 03-14-88, ES 06-15-88
Strategic Planning and Measurement System (SPMS), SRG 10-02-85
Strobane, TG 02-00-90
Strychnine, TG 02-00-90
Supplemental registrations, FCPP 3.2,  FCPP 3.9
Suspensions, ES 09-03-85
Target pest, FCPP 2.1
10-K statements, TG 10-17-80
Termiticides, ES 04-21-83
Thallium Sulfate, TG 02-00-90
TOK, TG 02-00-90
Toxaphene, TG 02-00-90
     cancellation, ES 01-01-83
Toxic collar. See Livestock Protection Collars
Transfer, TG 07-11-77
Tributyltin, TG 02-00-90
Trifluralin, TG 02-00-90
Truck fumigation, FCPP 3.3
2,4-D, TG 02-00-90
2,4,5-T and Silvex, TG 02-00-90
     cancellation, ES 03-07-79
     suspension, ES 04-05-79, ES 08-20-79
2,4,5-TCP,  TG 02-00-90
Ultra-low volume application, FCPP 12.5
Unregistred pesticides, FCPP 3.1
Use enforcement, FCPP 26.1
Use inconsistent with the labeling, FCPP 2.1
Use inspections, FCPP 12.3
Use recommendations, FCPP 2.1, FCPP 12.1

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Vegetable oil diluent, FCPP 12.5
Velsicol Chemical Corporation, ES 04-13-88
Vinyl Chloride, TG 02-00-90
Violation history, TG 10-17-80
Water purification devices, TG 08-30-75, TG 03-15-76, ES 10-00-80
Wood Preservatives, ES 10-23-86, TG 02-00-90
Worker protection program, SRG 06-13-89, SRG 07-31-89
Worker protection statements, TG 02-00-90
Written examinations, FCPP 4.1
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