A  ,
         :    UNITED STATES ENVIRONMENTAL PROTECTION AGE.NCV
                         WASHINGTON. O .C. 20460
                                                           OFFICE 3F
                                                           A MO TOXIC SUBSTANCE1
 MEMORANDUM

 SUBJECT:  Compliance/Enforcement Strategy  for the Federal
          Insecticide,  Fungicide,  and Rodenticide Act  (FIFRA)

'TO:       Al vi n L. Aim
14         Deputy Administrator


     Attached  is the Compliance/Enforcement Strategy for the
 Federal  Insecticide, Fungicide, and Rodenticide Act.   The
 strategy was developed  by  a work group  composed of Headquarters,
 Regional, and  State pesticides personnel,  and reflects the vi-ews
 of  al1 parti cipants.
                                                                 *
     The pesticides program is a well established program  that  has
 evolved  over the years  in  which States  have a major enforcement
 rol e.

     The strategy  is based on the  assumption that adequate resources
 would  be available to support a balanced credible program.  Because
 of  actual resource constraints, however, our primary goals through
 FY85 are 1)  to maintain th-e present monitoring/compliance  level  in
 States with  cooperative enforcement agreements, 2) to  negotiate
 cooperative  agreements  with the remaining  States, 3) to  refine
 the program  management  and oversight activities and 4) to  further
 develop  and  expand the  data audit/Good  Laboratory Practices inspection
 program.  To meet  these goals, we  will  perform the following activities
 through  FY85:

 o   Write FY35  Cooperative  Agreement Guidance.

 o   Develop a formal procedure for  and provide support  to the Office
    of  Pesticide Programs for most  new regulations and  suspensions/
    cancellations to ensure that the documents are enforceable.   CMS
    plans to  prepare a draft document on the formal procedure by
    the end of  the  second quarter of FY84.  Input and agreement  from
    the Office  of Pesticide Programs on  the procedure is  anticipated
    by  the end  of the third quarter of FY84 and should  be operational
    immediately thereafter.

 o   Develop compliance monitoring strategies and enforcement
    response  policies for most new  regulations and suspensions,  as
    appropriate.
    Finalize  strategy  for  conducting  data  audit
    Practices  (GLP's)  Inspections.
and Good Laboratory

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                               - 2 -


o  Finalize enforcement response policy for data auaits/GL?  inspd
   ti ons.

o  Ensure that all States and Regions conducting Federal  enforce-
   ment programs have fully implemented the most effective/flexi-
   ble system for allocating resources to priority pesticide
   problems.

o  Provide technical and legal support to States.

o  Provide training for State inspectors and chemists.

o  Prepare additional policies for the FTFRA Policy Compendiu-m,  as
   needed.

o  Promulgate a final FIFRA 4 rule requiring dealers' to  keep
   records- of their restricted use pesticide sales and  clarifying
   where commercial applicators must keep their records on their
   applications of restricted use pesticides.

o  Conduct Certification Programs in States without approved certi-
   fication plans.

o  Along with States, ensure that applicators are made  aware of
   changing technology.

o  Along with States, continue to certify new applicators.

o  Prepare guidance to encourage States to address- major  use problems
   in Certification and Training materials.

o  Prepare guidance which ensures that State Certification and
   Training materials meet Federal standards, as appropriate.

     As soon as we receive your approval to pursue these  activities.
they will be incorporated into the Administrator's Management System
with projected completion schedules.  Due to anticipated  resource
limitations, we will be unable to undertake the following activities
through FY85:

o  Expand FATES data to Include State data and ensure that FATES
   data 1s complete and current.  (CMS plans to request funding
   to Initiate this- activity  In FY86.)

o  Provide guidance and training to the Regions for data  audits/
   laboratory Inspections and case preparation.

o  Support all ruleaaking by the Office of Pesticide Programs.

o  Develop compliance monitoring strategies and enforcement response
   policies for all new regulations.

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                               -  3  -

o  Update the Pesticides  Inspection Manual.

o  Consolidate FIFRA Enforcement  Response  Policies.
                              
o  Revise FIFRA 7 establishment  registration  rule  and  reporting
   form to improve the usefulness of  data  in the  system.

o  Conduct periodic surveys  of  pesticide use to  improve the  priority
   setting system.

     Please let me know if you  have questions  or  would  like  to  further
discuss our plans for implementing  the  FIFRA Strategy.
                                  Don  R.  Clay"
                                  Acting  Assistant  Administrator
                                    for Pesticides  and
                                    Toxic Substances
Attachment

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         FIFRA COMPLIANCE /:ir ORC&MEN7 3T3A7TG:

Introduction                                           1
FIFRA Compliance Program Overview                      1
Previous Compl i ance/Enf orcemerrt Strategies             3
Present State of Compliance                           12
Goals and Priorities                                  13
Plans for Achieving Program Goals                     15
  Compliance Monitoring Plan                          16
  Compliance Promotion Plan                           21
  Noncomp1iance Response Plan                         23
  Heaaq-uart ers /Regi cnal Coordination                  29
  Federal/State Relationship                          29
  Cooperative Certification ani 7r ai i-i .-:
    Program              .                             31
  Cross Program elements                              3-r
Program Evaluation                                    3.6
Future Guidance                                       38
Appendix                                              39
  Figure I -  FIFRA Case Flow
  Table I -   Enforcement Actions Resulting
              from Grant Inspections FY81
  Table II -'Enforcement Actions Resulting
              from Grant Inspections FY82
  Table III - Federal Pesticide Compliance
              Inspections
  Table IV -  Federal Pesticide Enforcement Actions

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                 FIF3A Compliance/Enforcement Strategy
I nt roduct *, on
     This document contains EPA's strategy for acn^eving and main-
taining compliance witn tne requirements of the Feaeral  Insectici;e,
Fungicide, and Rodenticide Act (FIF3A) as anendea and implementing
regulations.  The document provides an overview of tne FIFXA com-
pliance/enforcement program, a summary of prior strategies,  tne
existing state of compliance, the current goals and priorities of
the program, recommended strategies for attaining these  goals, a
discussion of the roles of the Federal and State governments in
implementing strategy elements, a discussion of cross program
elements, and a description of the system for program evaluation.

     The major elements in this strategy are reflected in existing
guidance documents unless otherwise indicated.

     It should be noted at the outset that this strategy tak'es a
comprehensive look at the program and indicates a number of  actions
which should be taken to implement an effective program.  Sased'on
resource constraints, the actions which will be taken are limited
to those indicated in the priorities for FY85.

FIF3A Compliance Program Overv Jew

S t a t u t o ry 7 R e g u 1 atory Requi rements

     FIFRA, as auienaea, cjrrently haj a variety o f .ndc>. ar,; J.T.S to  rrz~
tect health and the environment from unreasonable risks  from pesticides
It contains the following requirements:

o Federal registration of pesticides.
o Submission of data to EPA by the registrant/applicant  for  registra-
  tion in support of registration, which shows that the  product,
  when used as directed will not injure man, animals, crops, or
  the environment and will not result in illegal residues on food
  OP feed.
o Federal classification of pesticides for general or restricted  use.
o Specific labeling of pesticides, including the product's  classifica-
  tion and proper use directions.
o Ch-ild Resistant Packaging if a product meets certain toxicity
  criteria and its label allows for residential use.
o Submission of a Notice of Arrival for all importations of
  pesticides or- devices.
o Certain labeling for all exported pesticides a-nd notification of
  EPA when unregistered pesticides are exported.
o Establishment by EPA of residue tolerance levels for products
  used on a food or feed crop.
o Experimental Use Penults (EUP's) for limited field testing prior
  to registration.
o FIFRA 18 Emergency Use Exemptions by the Administrator upon
  application from a State 1f certain criteria are met.

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o FIF3A 24 (c) State registration for additional uses : " i
  pesticide within a State to 
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     The 1972 amendments to FIFRA require the certification of
applicators to apply or super visa trie application o~ p es:; ;: ties
classified for restricted use.  Congress expected States to certify
applicators and authorized funding support.  The State -oooeracive'
Extension Servicas were to be utilized for the train i-g of  pesti-
cide applicators with EPA funding support.

     As of October 1983, all but 4 States have funded cooperative
enforcement agreements; all but 3 States have been  granted  use
enforcement primacy; and all but Z States have approved certification
plans.  As th-ese figures indicate, most FIFRA enforcement and certi-
fication and training responsibilities rest with the States.  EPA
activities include oversight of States with agreements, taking
enforcement action for cases referred by the States, conducting
enforcement and certification and training activities in States
without cooperative agreements, and conducting national compliance/
enforcement programs in areas where States have limited jurisdiction
or capability such as data audits/laboratory inspections, import
and export surveillance, and rodenticide/device testing, and regulation
development support.


Previous Compliance/ Enforcement Strategies

Pre-1980 Program Reassessment	

General Enforcement of FIFRA
     While the FIF3A anforcement pro^-am ^as located i  i t.: = 'J.-.:t=j
States Department of Agriculture (USDA), the enforcement program was
centralized witn all activities., inspections, case preparation ana
policy development conducted by Headquarters personnel.  After EPA
was formed, a Regional program was adopted.  Inspections and case
preparation were conducted by Regional personnel.  Concurrence from
Headquarters w.as required for all civil actions.  Headquarters
provided guidance and made policy decisions regarding the program.

     Prior to 1972,. the strategy for the Federal program was to
enforce product-related violations, I.e., mislabeling,  inefficacy,
chemical deficiencies, nonregistration.  There was no authority to
take enforcement action against improper use.  Criminal action was
-the only available- response against violators.

     The 1972 amendments to FIFRA 1) provided for administrative
civil penalties as well as criminal action, 2) made use incon-
sistent with the label a violation, 3) provided for cooperative
enforcement agreements with the States, and 4) required classi-
fication of p-est1ddes along with provisions for certification
and training (C & T) of pesticide applicators.  As. a result, the
Federal program shifted to Include enforcement of the label use
directions.  The use of dv1l penalties became the backbone of
the enforcement effort.  States were responsible for developing
CAT programs based on EPA regulations and obtaining approval for
      programs frtJiB PA.
         f

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Federal presence  in those States with agreements.

    . The Feaeral  enforcement program became more secantra1i222 i?
February 1375 when Headquarters announced a program to waive con-
currence for routine civil cases, excluding use cases.  3y  November
1978, all Regions were  granted  1) full relaxation of the requirement
for Headquarters  concurrence in actions related to stop sales
and civil cases other than misuse cases, and 2) partial relaxation
o*f HeaTtquarters coTrcurrance rn tire enforcement of misuse cases.

     The 1973 amendments, under certain circumstances, gave primary
responsibility for use  enforcement (primacy) to States.  As  mere
State programs became operational under cooperative agreements
and received primacy, Federal activities shifted to enforcement
programs in States without cooperative agreements and primacy,
program oversight, training of Stats personnel, disinfectant/device
tasting, import/export  surveillance, and data audits.

     Guidance for the cooperative agreement program was issued
annually.  until  1930,  strategies empnasizea a gradual shifc from
activities related to product compliance t-o t.iosa monitoring use.
Guidance documents assigned percentages to various a c t i /: t i * s
including agricultural, n o n i -. r i c u 1 t u r i 1 2 n : ey. ? e - i -^ e n t:'.  1-2
inspections; producer establishment, marketplace, import,  certified
dppiicdtcr r d c o r ii .$ insp^ctijna, a n u rsscr'iwCsu use p  3 c i c i ^ e w c a , c r
inspections.  The percentages correlated to the amount of total 
worlcyears EPA expected  the States to spend on the various  activities
Percentages were  assigned based on prior violation trends  and new
regulatory requirements.

Federal and State Certification and Training

     Prior to FY81 , the C 4 T program was operated by the Office
of Pesticide Prograas (OPP) independently of the compliance  program.

1980 Program Reassessment

     In June 1380, ths  pesticides compliance/enforcement program
was reassessed.  The resultant strategy document. "Reassessment of
the Federal/State Pesticides Enforcement Program", has guided the
Federal/State cooperative pesticides program in recent years.  The
document was the  basis  for major changes in the compliance/enforce-
ment program and  contained the following goals and priorities:

o Improve management of all State and Federal pesticides enforcement
  program elements by:  a) developing a priority setting system; and
  b) improving program  evaluation through a better information
  retrieval system, uniform evaluation standards, periodic  program
  evaluations, and appropriate program modifications.

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o Ensure tnat eligisie States receive primacy and aceq-.,itely
  the public.  This goal was to se acniaved by:  a) promu' :iting an
  interpretive rule on prirnacy standards; b) promulgating a regula-
  tion governing hearings for re-scission of privacy; c) issuing
  guidance on incentives and sanctions to encourage adequate State
  programs; and d) evaluating all State use enforcement programs.

o Ensure effective compliance monitoring and enforcement activities
  by assessing training programs and revising training inacarials,

o Ensure adequacy of the certification and training program by: a)
  reviewing State plans and certi f i.caion and recert i f i cat i on  proce-
  dures and Extension Service program materials; and b) revising
  training materials as appropriate.

o Increase public understanding of and participation in pesticides
  enforcement activities.  This goal was to be achieved by preparing
  materials and sponsoring training activities designed to help users
  minimize pesticide risks and to help persons exposed to pesticides
  in documenting misuse violations.

Implementation of Strategies	
     The Compliance Monitoring Staff designed and began implementing
strategies for achieving t'lesa goa's in 1?31.  A summary of ::i?53
strategies f ol 1 cws .

Improve Man a gement

P ri ori ty Setti ng.  The largest portion of the Agency's pesticides
compliance and enforcement resources are directed at pesticide
product and use activities.  These resources are used primarily by
the States through the cooperative agreement program but also by
the Regions 1n conducting FIFRA compliance programs in Colorado,
Nebraska, Wyomin-g, and Ohio and handling referrals from the States.

     In the past.. EPA Headquarters directed that resources in both
the State and Federal programs be allocated to compliance activities
based solely on general national priorities.  As a result of the
reassessment 1n 1980, EPA required both the States and the Agency's
compliance program to Identify priority pesticide problems and to
allocate resources to activities wftlch most effectively deal with
these problems.  To assist the States 1n this activity, the Compliance
Monitoring Staff (CMS), 1n conjunction with the Office of Planning
and Resource Management (OPRM), developed a flexible priority setting
model designed to ensure that resources in both Federal and State
FIFRA compliance programs would be applied in a manner which would
most effectively address major pesticide use problems arising in
individual States.  This model was included in the FY82 guidance for
Cooperative Enforcement Agreements and was referenced in the Guidance
for F-ederal. Programs 1n States without Cooperative Agreements.

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 Application of the model results in four products:

A list 3f pesticide use problems ranked by their .-^a:-
contribution to harm from pesticide use/misuse
                                                   i nci :2~t 3
2.  A- listing of pesticides  ranked by their relative con: ri out ' :-
    to ham from pesticide use/misuse incidents.

3.  A list of program  activities to be carried out to deal witi
    each of the identified problems, including both traditional
    compliance monitoring and enforcement efforts as well as
    other activities such as increased education,

4-.  An allocation of program resources that maximizes potential
    program effectiveness by considering 1) the relative priority
    of rhe use problem  addressed; and 2) the likely effectiveness
    of the proposed activities in dealing with that problem.

     All States have begun implementing this model or a related
method for identifying  priority pesticide use proolems and
effectively allocating  available resources.

     The FY82 Cooperative Agreement guidance g~ave general directions
for setting non-use priorities but contained no specific model.
Upon request of the States,  such a model was developed for the
r Y 3 4 guidance.  Because narm is 1 i < e 1 y to oe greater for use-ralatea
activities and the compliance rate is generally hign for non-use
related activities, t " e ranking procedure suggests that 25* of
available inspection .- 3 s 7 >j .- c a s 33 allocated to .-. o r: - u s a r a 1 a t a j
activities.  Under the  ranking procedures suggested for non-use
pr'uP't'sj, cc ."ujj i i a 1*1 c e  iii j ~t 1 1 J i* ' 'i  priori ty i j d^^ijnej i r> u .1 ^
following order to establishments within a State which produce
restricted use pesticides (RUP), pesticides subject to the Label
Improvement Program (LIP), and pesticides likely to be subject to the
Child Resistant Packaging (CRP) requirements:

1. Violators 1n the State
   a) Establishments with major violations.
   b) Establishments with multiple violations.
   c) Establishments with minor violations.

2. Establishments not  previously inspected.

3. Establishments previously inspected with no violations detected.

Information System,  A  strategy for improving data storage and
retri eval for both the  pesticides and toxic substances compliance
enforcement programs was initiated in 1979.  Prior to 1981, the
Compliance Monitoring Staff  had two ADP systems: 1) the Pesticide
Enforcement Management  System (PEMS) which contained inspection,
sampling and case development data, and 2) tne Establishment Regis-
tration Support System  (EUSS) which contained FTFRA 7 establishment
registration data.  In  1979, a strategy was developed for consoli-
dating expanding, and  improving these systems into a new automate^
data system FATES (FIFHA and TSCA Enforcement System).  FATES con-
sists of five subsystems which operate independently with cross
reference capaij-f H-!*T:

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o Pesticide establishment registration and production -200;-ting
o Inspections and sampling
o Case management
o Grants information
o Contract inspect ions

After a feasibility study in 1979, a system design phase was
initiates in 1930.  Development and Implementation was b-egun in
early 1931, and by October 1981 FATES was operational.  Regional
system installation .and user training was accomplished in 1982,
and system validation was completed in 1983.  However, major FATES
data base system updates and enhancements are required to maintain
data for new program activities such as the FIFRA Child Resistant
Packaging and Label Improvement programs, and to provide compretieTi-
sive information for the Administrator's Management Accountability
System.  Additional ADP contract, resources are required to provide
these system enhancements and to maintain the additional data the
new programs generate.  When fully operational, FATES should facili-
tate priority setting.

Uni form Standards.  In 1982, an evaluation protocol was included in
the FY83 cooperative agreement guidance.  The protocol was developed
1) to ensure that all State cooperative enforcement and C 4 T programs
would be evai uated. annual !y by the Regions according to uniform stan-
dards; and 2) to ensure that appropriate pesticide usa problems would
ba addressed in State pesticide applicator training and certification
mat'a rials.  T'nis protocol was developed for d 5 a in ~ Y 3 3 an.} will 36
modified as appropriate based on experience with its use.

Information from program evaluation is particularly important,
since it is to be used by the States to update priorities for the
next year and to determine specific areas needing additional
regulation (for example, through OPP's label improvement program).
This use of priority setting and evaluation gives the program an
element of flexibility which allows resources to be allocated each
year to those areas where they are most needed and can be most
effectively used.

Primacy

     At the request of the States, EPA developed a rule Interpreting
several key provisions in 25 and 27 of FIFRA.  The Interpretive
Rule promulgated on January 5, 1933 addressed 1) when a State will
be deemed to have adequate pesticide use laws and enforcement proce-
dures, 2) criteria used by EPA to determine whether a State is
adequately carrying out primacy. 3) EPA procedures for referring
misuse allegations to tne State and tracking State responses. 4)
the meaning of appropriate enforcement action, and 5) factors con-
stituting an emergency and circumstances under which EPA will defer
to the State for enforcement.  Generally, tne Agency determines
whether a State should be granted primacy or whether its use program
Is adequate based on a review of the State's entire program rather
than a case by case review.  EPA evaluates a State's primacy program
during the end of the year grant review for those States with coopera-
tive enforcement programs,

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                               - a -


     On May 11, 1981 EPA promulgated a rule (45 FR 25353'  govarni
procedures to be followed by the Administrator in rescinding
primacy.  Under these procedures, whenever the Administrator ma
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Certification and
Training Program

     In FY81, OMB transferred trie program to tne corns';
enforcement program.  This transfer provided an opportunity to
better coordinate the two programs.

     FIFSA provides that certification of pesticide applicators
be accomplished under State Certification Plans approved by
EPA with training provided by the State Cooperatw-e Extension
Services (SCES's).  This objective has been largely accomplished.
Only Colorado and Nebraska lack approved certification plans and
only the Colorado* SHE.S fails to provide applicator training.  In
each of these States, EPA has established programs in the absence
of State activity.

     Three Federal agencies, the Department of Defense (ODD),
the Department of Interior (DOI), and USOA, have established pro-
grams to certify their own employees.  These programs are authorized
by EPA to allow Federal agencies to certify their employees to apply
pesticides anywhere in the performance of their official  duties.
Federal employees can still be certified by States, but their certi-
fication has the same geographic limitations as other applicators
certified by the Stite.

     Based on operational experience, there has been a need for 5:r>e
changes, and certification plans have been amende-! in res pens a 12
these needs.

     Certification plans were required to contain a provision Keeping
applicators abreast of changing technology.  This requirement is
generally met by recertif1cation either at specified intervals or
when deemed appropriate by the State.  Most States have completed at
least, one recertlfication cycle.

     EPA has worked with USDA to develop training material.  There
1s need to periodically update the material in order to incorporate
Information on new technology,  existing training material  is
cataloged at the USDA Beltsville library.

Additional Activities - Federal Program	

iTvput f-nto Developing-nt of New Regulations

     To ensure that new regulations are enforceable, CMS participates
and assists 1n the development of regulations or other regulatory
actions such as suspension/cancel!ation orders for which the Office
of Pesticide Programs (OPP) has the lead role.
   *Colorado has 1n.d1c.ated an Interest In establishing a program,
which w1^l initially cover only commercial applicators.

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                            - 10 -


General	

     As mentioned previously, the Federal ro^e sni*t22, as nc~2
States received grants, to the oversight of the ccooerative program,
enforcement response for State referrals, en f orcement programs in
States without cooperat-ive programs or primacy, ana a compliance
monitoring and enforcement program consisting of data audits,
import and export surveillance and efficacy testing.  With the
exception of the data audit program, which is managed at Headquarters,
the Regions have primary responsibility for the Federal Program.
CMS provides guidance documents, policy interpretations, technical
support, and oversight for Regional activities.

Data Audits
     The data audit program for studies submitted in support of
pesticide registration was instituted in 1975 after the Food and
Drug Administration (FDA) found that studies submitted to it had
serious deficiencies.  The strategy has been to audit studies at
pro.blem laboratories, audit studies of special  significance to"
regulatory decisions, and conduct routine audits at all pesticide
laboratories.  Under an Interagency Agreement originating in 1973
F3A conducts inspections at laboratories whiz in  conduct healtn
effect studies.  A inspectors primarily conduct audits of environ
mental studies.  EPA scientists participate on  audits as aoorsp
A Sat a Audit P-anel within Office of Pesticides  and Toxic Su'ostat
(OPTS) targets inspections, reviews reports, and recom-
FIFRA Imoort Surveillance
     Compliance monitoring of the import provisions of FIFRA is
performed In cooperation with the U.S. Customs Service.  Customs
inspectors screen imported pesticides and allow only products
which are in compliance with FIFRA to enter the United States.
If a pesticide appears to be 1n violation of FIFRA, the Customs
inspector stops the entry of the pesticide into the Customs
Territory of tfte United Staes and refers the matter to the appro-
priate EPA Regional Office for resolution or enforcement action.
In addition, a Notice of Arrival form is required to be submitted
to" EPA for all importations of pesticides and devices.  An annual
average of 4375 Notices of Arrival hat been received and 670
inspections of imported products have been conducted for the past
few years.

Efficacy Testing

Disinfectant Testing

     The Federal program for disinfectant testing, which is no
longer active, involved eff1.ca.cy testing of hospital disinfectan
Sucti testing is important considering that failure of hospital

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disinfectants can contribute to the incidence of in-'-tions  aiong
vulnerable patients and result in unnecessary and j -;-.: -^ !? g  e.ocs'j-e
of nosoital staff to pathogenic organisms.  0?3's Seltsville
laboratory formerly performed efficacy testing on aoout 200  sables
per year.  The failure rate ranged from 4 5 X of 111  s a -a 1e s in  1930
to 72% of 40 samples in 1982.  T.'ne Beltsville laboratory suspencea
testing of disinfectants,  sanitizers,  sterilizers,  ana germicides
in October 7S32 due to competing higher-priority needs, altnougn
the capability to perform such tests remains.  CMS  proposed  an"
efficacy testing program for FY85; however, it was  not included in
the priority listing of .OPTS programs.

Ultrasonic Device Testing Program

     Under an Interagency  Agreement between the FDA's Winchester
Engineering Analytical Center and EPA's CMS, the FDA tested  the
acoustical properties of a dozen different ultrasonic pest control
devices being manufactured in the United States.  This information
was used to select "representative" devices for testing the  principl
of ultrasound on rodent control.  The  efficacy testing is being
conducted under a separate Interagency Agreement with the Denver
Wildlife Research Center,  Fish and Wildlife Service  and CMS.m  A
final report on the first  of six devices was recently received,
and the other tests and reports will be completed by February
1984.  CMS and OPP will use this information in the  regulation of
ultrasonic device labelling claims which are overstated.

Electromagnetic Device Testing Program

     A program similar to  the ultrasonic program was conducted
for devices which purport  to control pests utilizing the principle
of electromagnetism.  The Bureau of Standards, through an Interagenc
Agreement with CMS, conducted the electronic analysis of eighteen
different devices.  University and USDA personnel conducted  efficacy
tests on rodents and insects for CMS and determined  that electro-
magnetic devices were ineffective for  these pests.   Appropriate
regulatory actions were taken by CMS which resulted  in the ban of
these types of devices from the consumer marlcetpl ace.

Rodenticide Efficacy Testing

     The Office of Pesticide Programs  funded an Interagency  Agree-
ment with the Denver Wildlife Research Center in FY83 to conduct
a national program to test rodenticides for efficacy.  CMS is
participating in this program by coordinating the sampling,
chemistry testing, efficacy reviews, and enforcement response, if
any, for the rodenticides.

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                               - 12 -

M on i 13 ri n g of Federal Srray Programs	

     The EPA tnrough  tne Federal enforcement program or t.-.e
cooperative State programs routinely monitors spray pr^ra.os
funded by Federal agencies.  For instance, applicators'::;/
for-hirs applicators  during the Grasshopper Control Program nave
been monitored by the States of New Mexico, Texas, and Oklahoma,
and by EPA in Nebraska and Colorado.  The EPA and tne States
may also conduct use  investigations for smaller scale programs
including aquatic weed control, forest p-est control, and pre-
dator control programs.


Present State of Compliance

Regulated Community	

The following is a list of known members of the regulated community:

o Number of Rsgistsrsd Establishments                     1-1,000

o Number of Applicators Trained and Certified

  Private                                              1,500,000
  Commercial                                          -   495,000

o Number of Laboratories Conducting FIFKA Studies            -03

o Number of Notice of Arrivals Received in 1982 (imports)  5,014

o Number of Export Notices received annually (approximate)    75

o Number of Experimental J;a Permits Issued in 1982          441

o Number of 18 Exemptions issued  in 1932          "         373

o Number of Restricted Use Pesticide Dealers              23,706
  (This number does  not include dealers in Colorado,
  Montana, or North  Dakota.  It 1s estimated that
  these States have  approximately  300 RUP dealers.)

     This 11st does  not Include Information on the total number of
pesticide users or pesticide dealers of unrestricted pesticid-es.
Many users of pesticides only  use  general use pesticides and there-
fore are not certified.  This  is especially true  of homeowners who
are not commercial applicators OP  farmers.  Although the unknown
categories represent a large number of persons, the overall impact
of violations by this group which  go undetected is much less than
the effect of violations by members of the known  regulated community
Violations by the known community  may Involve more highly toxic
pesticides OP product type violations which impact a large number
of .people if left undetertsd.  Violations by private users who
uncertified generally affect a more limited population.  In add
violations by users  *h1cn  result 1n serious harm  ape likely to be
reported to the Agency.

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                               -  13  -

Inspections and Actions
     The shift from a  Federal  to  a  State  program  has  res
increased number of inspections  and  increased  field  presence.   A
complete data oase  on  enforcement  actions  wnich  induces  State
activities only exists for FY31  and  FY82.   In  FY31 ,  a  total  of
50,104 State  inspections  was  conducted.   The  percent  of  inspections
resulting in  action was  17.4.   In  FY32,  a  total  of  59,317 State
inspections was conducted.  The  percent  insoections  resulting  in
actions was 13.1.   Violations  figures  for  specific  types  of
inspections indicate a higher  rate  of  noncompliar.ee  *':r  use  related
requirements  than  for  non-use  related  requirements.

     The number of  Federal inspections for FY81  and  FY82  was  225
-------
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     Priorities for the FIFRA compliance/enforcement program through
FY85 fall into the following management, compliance monitoring
enforcement response  and certification areas:

Manaaement
o Write FY85 Cooperative Agreement Guidance.
o Develop formal procedure for and provide support to OP? for most
  new regulations,  suspensions/cancellations and other actions to1
  ensure that the documents ara enforceable.  In order' to do this
  effectively, it is mandatory that compliance/enforcement program
  staff be involved early in the development of such documents.
  This has oeen a problem in the past.  Therefore, a formal  syste
  of communication  between OPP, Office of General Counsel, anc C.MS
  should be developed.
o Finalize strategy for conducting data audits and Good Laboratory
  Practices (GLP) inspections.
o Finalize enforcement response policy for data audits/GLP
  inspections.
o Develop compliance monitoring strategies and enforcement response
  policies for most new regulations and suspensions, as appropriate.
o Ensure that all States and Regions conducting Federal
  enforcement programs have fully implemented the most effec-
  tive/flexible system for allocating  resources to priority
  pesticide problems.
o Provide technical and legal support  to Strata*
o Provide training  for State Inspectors and chemists.
o Prepare additional policies for the  FIFRA Policy Compendium, as
  needed.
o Promulgate final  FTFRA 4 rule requiring dealers to keep records
  of their restricted use pesticide sales and clarifying where
  commercial applicators must keep their records on their applica-
  tions of restricted use pesticides.

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Compliance .Monitoring
                               -15-
     Program guidance indicates tn at generally 75" 3- :~::e:~^:r:
resourcas should be directed at use probla-ns and 25" at :-oc-jct
relatad priority problems.  The priority setting gui^a^ce '3 iesignec
to be flexible, allowing a shift in inspection targets -rom year to
year based on shifts in State specific problems ana new r!-RA
regu1 at i ons .

     In addition, the Federal program will emphasize tne data
audit/laboratory inspection program.

Enforcement Response	 	
     States will set their own enforcement priorities with major
emphasis being given to priority use problems which they have agreed
upon with EPA.

     The Agency attaches the highest priority to responding to the
following instances of noncomp1iance:

o Violations relatad to those priority use problems which
  EPA and the State have agreed  to track under primacy and
  for which the State does not take appropriate action.
o Violations related to other priority use probla-s established
  by the States or EPA.
o Submission of falsa data to EPA in conjunction with ?esti::.:a
  regi strati on .
o Sale of Restricted Use Pestic'ides to uncertified applicators in
  Statas with Fadara' Programs.
o Label or formulation violations likely to result in harm to
  health or the environment.
o Violations of Child Resistant  Packaging regulation.
o Pesticide enforcement registration and reporting violations.

Certification
o EPA will conduct Certification Programs in States without
  approved certification plans.
o EPA and States will ensure that applicators are made aware of
  c&anqing technology.
o EPA and States will continue to certify new applicators.
o EPA will prepare guidance to encourage States to address  major use
  problems 1n C X T materials.
o EPA will prepare guidance which ensures that State CAT  materials
  meet Federal standards, as appropriate.

Plans for Achieving Program Goals

     This section discusses the compliance monitoring plan, the
compliance promotion plan, plans for responding to noncompl iance,
certification and training, Headquarters/Regional coordination,
Federal/State relationship, and cross program effects.

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                               -  10-


Como "Nance Moni tori no Plan	
Object!ves
     The basic objectives of the compliance monitoring r'an are:
1) to provide a visible enforcem-ant presence which wil: encourage
voluntary compliance; 2) to collect evidence to support enforcement
actions; 3) to expand the data base for determining compliance oy
the regulated community (FATES) and to use this information to
identify persons likely to be in noncompl iance; and 4) to discover
problem areas requiring resolution through re-gulatory initiatives
by OPP.

Compliance Monitoring Tools	
     Tools available to EPA and the States for monitoring compliance
with FIFRA include data review, letters, and on-site inspections.

     EPA can determine by reviewing available data whether an
establishment has met its 7 reporting requirements or wnetter
there is some questionable registration data.

     Letters are used to determine which specific industries are*
actually subject to FIFRA requirements when a full scale on-site
inspection is not co-st -effective.  They are generally usaa wnen
purposeful noncompliance is not suspected and the likelihood of
response is good.

     On-site inspections are the major method through which EPA
monitors compliance with TTrSA.  T>.<=SS i -spaztl z~- zr* co."--cts-
in response to complaints and on the basis of target selection
under a neutral administrative inspection scheme  (NAIS).

Inspections Based on Referrals/Complaints

     Both the Agency and the States place a hi gh priority on
response to complaints or referrals regarding violations.
Referrals, tips, and complaints are particularly  important to
EPA compliance monitoring for misuse.  This is because FIFRA 9
gives "EPA inspectors authority to enter only establishments where
p-esticides are held for distribution in commerce.  It does not
clearly give EPA authority to enter places where  pesticides are
being used.  Therefore, the Agency can enter such places only with
T) consent of the owner or his agent, or 2) with  a warrant based
on probable cause that a violation has occurred,  or 1s occurring.
Probable cause can be based upon a detailed allegation from a
reliable source 11 Hiring specific action with a specific misuse.

     Some State statutes give their Inspectors broader entry
authority to detect misuse.

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                               - 17 -


     Misuse is difficult to detect unless an inspect;-" : 3 2 -  5 e n t
during actual use or soon a.Ttar tne use of the pest i c: .; = .  "^ere-
fore, use inspections are conducted in resoonsa to a  cr~c',i:nt
referral or during trie actual application of trie p.^sf'c'^e.  -29''-
timate complaints/referrals regarding pasticiie r. is use ^ay 22
ineffective if tney are not made and investigated oromotly oecause
the evidence, especially in the case of highly toxic  organopnosonates
will no longer be there at the time of the investigation.

     Even if there were no limitations on entry authority, evidence
of pesticide misuse may be difficult to detect during a planned use
observation.  Because inspectors would not generally  otherwise know
when and where a ctmnnercial or private applicator is  going to tr.a'  ",-
States to determine whether the requirement is being met.  In
addition States can follow-up the records and inspect the applicator
to determine whether he is certified.  Based on records which
commercial applicators are required to keep, it-is often possible
for the States to determine whether the RUP was used'in accordance
with its label instructions.

     EPA does not have regulations requiring dealers in States
without cooperative agreements/primacy to keep records regarding
their sales of RUP's.  As a result, it has been difficult for EPA
to determine whether dealers in these  States have sold RUP's
to uncertified applicators.  Although  Federal regulations exist
requiring commercial applicators to keep records regarding their
RUP applications, the regulations were unclear about where these
records had to be kept.  However, EPA  expects to remedy these
problem* by promulgating a final rule  under FIFRA 4 requiring
dealers to keep records of their RUP sales and clarifying where
certified commercial applicators must  keep their records on their
applications of RUP's.  This rule should appear 1n the Federal
Register early 1n FY84.

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Ta rge 11 i n g
     As indicated on page 6, EPA and the States use  the  priority
setting system for pesticide use/misuse to determine specific
categori.es of persons who should be targetted for inspection.
Selection of specific p-ersons within each category is  based on  an
NAIS.  The system is flexible and may vary from year to  year based
on major existing or anticipated problems.  Each neutral  scheme
includes a set of criteria designed to help the Agency and  States
achieve the best cost/benefit ratio between the use  of compliance
monitoring resources and detection of violations.  The criteria
applied to all facilities under a neutral scheme vary  based on
individual priorities but generally include the following:   viola-
tion history, production volume, amount of specific  pesticides
used, inspection history, and location.   Inspection  targets are
selected at random based on available resources from the  facilities
identified through application of the NAIS criteria.

     The current use/misuse priority setting system  is based -
primarily on data in case files and incident files.   It  thus
yields priorities which are responsive to previously existing
problems which posed actual harm.  This system should  be  com-
plemented by one aimed at predicting potential for harm based
on trends in the quantities and types of pesticides  used.   Such
a system would require periodic surveys of pesticide use  by the
States and/or EPA.  To date, resource limitations have prevented
further exploration of .this option.

     The priority setting system for product/faci1ity  related
inspections  (see page 7) results in the targetting of  specific
persons and products for inspection.  Again priority is  based  on
a number of factors including violation history, production of
products most likely to result in human or environmental  harm
if violative, and the need to show a government presence  for
important new regulations.  Since States and Regions will  use
this system for the first time in FY84, EPA may need to  make
adjustments in FY85.

     To assist in targetting use inspections, the Agency  needs  to
encourage the successful generation and transmittal  of referrals,
tips, and complaints in both misuse and use areas.  Therefore,  EPA
should undertake the following activities:

Expand Formal Referral Systems
Within the Agency	

     A system for data audit/laboratory inspection referrals exists
between the Office of Toxic Substances  (OTS), OPP, and CMS.  Also,
OPP provides  referrals regarding products not in compliance with
the Child Resistant Packaging Regulations.  A formal system for
referrals for other requirements should be developed.   EPA should
encourage States to develop similar referral systems within each
State.

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                                -  1 9  -


 Expand  Referral  Systems
 With  Other Agencies	

      While trie Agency  has  referral systems  for  specific tyoes of
 products  or  violations witn FDA,  Consumer Product Safety Comnissio-
 (CPSC), Occupational Safety and Health Administration  (OSHA), ana
 Federal Trade Commission  (FTC), it should expand the systems.  EPA
 should  encourage States to set  up  similar systens.

 Improve Referral System
 Between the  Regions and States

      FIFRA 27 requires EPA to  refer all significant allegations
 of pesticide misuse to the States.  The Interpretive rule provides
 specific  procedures for the referral and tracking of such cases.
 Although  all Regions have  implemented informal  referral and trackin
 systems,  some systems  are  better  developed  than others.  All the
 Regions need to  implement  a formal system.

 Expand Work  with the Press
 and Special  Interest Groups

      Botn EPA and the  States periodically encourage the national
 and local trade  press  to write  articles on  new  and existing pesti-
 cide  control requi rsments.  
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                               - 20 -

away from requiring a specific frequency in its guidance.   I
t n e Agency suggests that frequency be estaolisnea 11 ^ c u : -i  tie
priority setting system.  This is trua for ^lisusa 33 *-''.  a;
establishment inspect ions.                                       '

     Laboratories are exoected fo oe inspected under -.12 data aucit/
laboratory inspection program every 2-3 years.

    Inspections at device producing establishments should  be  oart
of the routine inspections of establishments manufacturing general
use pesticides.  When the Agency is conducting a major testing
program for specific devices, samples are collected at Headquarters'
request or in response to complaints.  Types of devices for which
t-esting has b-een/is being conducted are water purifiers and elec-
tromagnetic, supersonic, and ultrasonic devices with rodenticide or
insecticide claims.

     Disinfectants are collected as part 'of a State's routine
inspections.  Since the Agency no longer conducts efficacy testing,
there is no separate program for disinfectants.

     Rodenticides are collected as a result of sample requests
prepared by CMS.  Samples are requested based on an OPP prepared
list of products which OPP believes should be tested.

Follow-uc Insoections
     Follow-up inspections are conducted when inore information
is needed for a possible enforcement case or when violations
^ 2 v e bean f c 'j ~ d 2nd t h a R3rtio*v'St2ta d a ta TI ^ ?  s * *^ * * ' n o * h a **
inspection is necessary in order to assure compliance.  The
frequency is determined on a case-by-case basis depending on
the need for a follow-up Inspection to assure compliance.

Inspection Quality	
     To ensure inspection quality and the evidentiary value of com-
pliance monitoring information collected by the States, EPA will
continue to provide training for State pesticide inspectors and
State pesticide chemists.  The types of training provided by EPA
are described under the training section on page 9.  Aside from
training, basic guidance on the conduct of pesticide inspections
1s contained in the Pesticides Inspection Manual.  This manual
m be up-dated and revised 1f resources for this activity are
available 1n the future.

     In addition to providing training and basic guidance, EPA
reviews State Inspection reports to ensure that inspections are
conducted properly, appropriate inspection procedures are followed,
and sufficient evidence is collected to support enforcement actions.
This review 1s normally conducted as part of EPA's routine oversight
of the cooperative prog-ram durl-n-g mid-year and end-of-year reviews.
This r-evvew activity -*i 11 continue.

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     In accordance with the Agency's Quality Assurance  ' - ^ ,'  require
ments, States receiving grant money through tne coooe r-a c i ve  enforce
ment program must develop QA Plarcs covering botrt compliance  mcnitop
and sample analysis.  These QA Plans must be submit-ec  to  tne  Regio
Quality Assurance Officers annually for review and aporoval.  Tne
Compliance Monitoring Staff, with the approval of tne  EPA  Quality
Assurance Management Staff of ORD, has provided guidance  to  the
-egions and States on the development of QA Plans.

Compliance Promotion Plans

Objecti ve	
     Compliance promotion is an important component of any
successful compliance program.  The objective of compliance pro-
motion 1s to ensure that the regulated community is aware of
the requirements of FIFRA and related Scate pesticide laws and
understands what it must d.o to comply.

     Since neither EPA nor the States have sufficent resources ts
Inspect every member of the community regulated under FIFRA, both
must depend largely on voluntary compliance.
 ool s
     EPA and the States promote voluntary compliance witn
through the following mechanisms.

Educational Proarams
Certification and Training.  Perhaps the most widespread compliance
promotion tool is the pestici de applicator training and certifi-
cation program.  This program is conducted by EPA in two States
and in other States by the States themselves.  It ensures that both
private (farmers) and commercial applicators (all others) are not
only aware of pesticide use requirements and generally competent
to apply pesticides but competent in particular to apply restricted
use pesticides.  Training materials are frequently revised,  and
EPA will issue further guidance in FY85 directing that information
from the priority setting process be incorporated into certification
and training materials and examinations as appropriate.  Implemen-
tation of this guidance will be dependent on availa-ble resources.

Other education programs.  These programs are designed to promote
safe pesticide use.  An example is Project SAF. which is sponsored
by the National Aerial Applicators Association and the Extension
Service and is supported In part through cooperative agreement funds
During the first phase of project SAFE, trainers were trained to

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                              - 22 -


 conduct  fly-ins* to teacn  aerial  applicators  better  ca  : : -at: :--
 tecnniques  to minimize pesticide  drift  and  to  obtain  estiva*  sest
 control  with  the niinltnu^i amount  of pesticide-   The~=  -,275  tee^
 three  trainer fly-ins  which  involved  approximately  -3  States.
 During the  next  phase  of the  program,  these trained  specia 1i5*3,
 mostly cooperative  extension  staff, will  be conducting  fly-ins  for
 aerial applicators  in  their  States to  help  the  applicators  calibrate
 and  apply  pesticides  in the  most  environmentally  effective  manner.

 Farmworkers  Program

      Several  jr*r  ^ago, tfrve Agency initiated a .pro-gram  to ev.al-u.at-e
 the  specific  problems  of pesticide misuse  related to  farmworkers,
 especially  the  migrant farmworker.

      In  1974, the  Agency promulgated  40  CFR 170 Worker  Protection
 Standards,  which addressed  four  basic  protections to  persons
 engaged  in  agricultural hand  labor in  the  field:  1)  protection
 from being  sprayed, 2) reentry periods  (one general  and  12  specific),
 3) protective clothing, and  4) warnings.   The worker  protection -rule
 found  in  40  CFR  170 are implemented through the labeling  of  agricul-
 tural  pesticides.   The regulation is enforced at  the  registrant  '
 level  by  requiring  sp-ecific  label  language.  The  regulation  is
 en-forced  at  the  user  label  in  that it  -is  illegal  to  use  a pesticide
 in a  manner  inconsistent with  its labeling.  A  .vor:
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                               - 23 -

   fended and Cancelled 3asf!cidas booklet.  T n -; 3 boo <'.--.
    area oy CMS in 197/.  It was conpiiad to sunna'^a i": t'ar*
   Tncy actions on pasticiias which nave bean suspense c, :^-,ca"'ec,
or otherwise restricted.  It was designed as a qu:c< ~='a~a^ca gu':;
for use by pesticide inspectors but is available to t.~a cuol't.
                                *
Publication of Results of flajor Testing Programs.   - "i 0 c t o o e r  1 9 3 C ,
CMS issued a puolication called ihe_Invest 1 gat ion of Efficacy  a?c
Enforcement Activities Re"! a fine to elect re ^ic^atr:  P'est'Contro'
Devi cesl  fhe results of tne ultrasonic testing program wilt a '> so
be published in the future.  These types of  puolications ara useful
to other Federal  regulatory agencies, consumer groups, foreign
countries, prospective producers of such devices, and to the public

Notices of Judgment.  Under Section 15(d) of FTF3A, EPA publisnes
enforcement actions tanen against violators.  It is believed that
the Notices of Judgment have some deterrent  effect.

Press Sel eases.  TK. 933 ara  ganarally issued  when major violations
occur or if public attantic-n has besn focusad on a-case.

Personal Contacts
Compliance Inspections.  Discussions of regulatory requirements
during inspections a'io provide a system for educating tne regulates
    unity concerning specific FIFRA requirements and tne nee-: to
Public Presentations.  EPA personnel give presentations and
parti ci pat a in pane !  i:  cut- i :r. 2 at : -.iust -y zzr, f srar.ces ,  :=.r,; -i,-3 ,
and other public meetings.

Noncomol i ance Response Plan

     The objectives of a program for responding to instances of
noticorapl i ance are 1)  to ensure that violations and resulting pro-
blems are promptly corrected;  2) to quickly and effectively take
equitable enforcement action against violators; and 3) to deter
similar noncompl i ance in the future.

     A broad range of enforcement responses is available under
FIFRA, including advertisement letters (i.e., letters to registrants
regarding advertising claims), warning letters, stop sale, use and
removal orders, request for voluntary recalls, seizure, injunctions,
administrative civil  penalties, criminal penalties, suspension or
revocation of certification, refusal to accept data from labs
refusing inspection,  suspension/cancellation of the registration,
and revocation of the establishment number.

     Detailed guidance for selecting the appropriate response is
  ailable to the Regions and States in the 1983 FIFRA Compliance/
  forcetnent Suidance Manual and in the Civil Pmalty Policies
  sted on page 25 under the Administrative Civil Actions Section.
Inspections will continue to be conducted with increased frequency
at those estabHshaenls with a violation history.

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                               - 28 -


3 a ^'j sal  to Ac cast Data f*om Laboratories Refusing '. n;c:?:"'3^s

     This policy is stated in the final  FIFRA Good Laboratory
Practice Regulations (GLP's) which are to be pronu 1 gacaa in FY3-i.

Suspension/Cancellation of Ragistration

     This is an action whien may be considered if the statemen-
of compliance or noncompliance with the  GLP's that is to be
submitted along with any data under FIFRA 3 is falsified.  This
action is discussed in the final FIFRA GLP's.

Termination of Establishment Registration

     The regulations on the registration of pesticide-producing
establishments (40 CFR 167.3) state than an establishment
registration will remain in effect so long as the establishment
continues to submit annual pesticides reports.  If an establish-
ment does not submit an annual pesticides report within 20 days
after receipt of a Notice  of Warning or  civil penalty for failure
to submit the report, EPA  will initiate  procedures to terminate  .
the establishment registration.

        Facilities
     Generally,  if Faiaral  Agencies are fcuni in vis lav en of =;.",-,
the EPA does not issue penalties.  This is in accordance  with Exec-tiv*
Drier 12088, Federal  Comolianca With Pollution Control Standaras,
which established a government wide program for ensuring Federal
facility compliance with pol luti on ''control requirements.   Instead of
assessing penalties,  EPA tries to resolve the problem.  First, a
Notice of Warning is  issued to notify facility managers of violations,   -
and the EPA works with the violative agency to establish  a remedial
plan.  If the problem cannot be resolved between agencies, the matter
Is referred to OMB.

     With regard to criminal action, the Department of Justice
has indicated it would not allow EPA to file suit against another        '*
Executive Agency.  In FY 1983, EPA issued a warning letter to the
Fish and Wildlife Service for failure to comply with the  pro-
visions of an EUP.

     The EPA Office of Federal Activities has developed a Federal
Facilities Compliance Program Strategy which outlines how EPA
Headquarters and Regional offices will handle Federal facility
compliance activities.  This strategy covers:
         cal Assistance - to ensure cost effective and timely
    ompliance.

o  Compliance Monitoring - to -monitor actual compliance.
         *
o  Fiscal Planning Assistance - to assist OMB 1n evaluating budget
   '5^^P^^^^^>^rr*^rT?^Tr7STri ,. ...4*t
          A IMI  4**j u w tOiu^ < j w i  ..
       monitor use of funds.

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                               - 30 -


Cooperative Enforcement Program	

     As tne cooperative enforcement program has eve ;/?:, t'?e S: = tas
with agreements have accepted increasing rssponsiblity  ana now snare
fully in all phases of the program with E ? A .

Co mo 1 i ance/E nf orcement Activities

     The States with cooperative agreements conduct all FIFRA
compliance monitoring activities related to pesticide production
sale and use.  Federal inspections are limited to those related to
data audit, imports, and assistance upon State request  in major
sp"ray progr-aws in the Stat.  (Th-es-e major spray programs are
usually funded by Federal agencies.) In addition,  EPA through
NEIC provides technical assistance including:

o pesticide use investigation workshops
o state-of-the-art techniques for monitoring pesticide  drift
o conducting state chemists training courses
o evaluating State pesticide laboratories and providing check
  sample analyses

     Under the terms of the cooperative agreements, States will
take all enforcement actions on violations of only  State law and
will re"?er all -rl ol ati on-s of only Federal law product and establish-
ment registration requirements to EPA for en fa reamsnt action.
Where * n e r e is a violation of both State ana Federal  law, a State
may take enforcement action itself or refer the case  to EPA if it
is unvn'lling or -jr.able to do so.

     All States with cooperative agreements also have primary
use enforcement responsibility (primacy).  Under the  terms of FIFRA
26 and 27 and the final rule interpret!ng these sections, EPA
may not take enforcement action on a significant case referred to
the State unless the State does not take adequate and timely enforce-
ment action.

Stats Program Oversight	
     EPA has primary respon-sibi 1 ity for cooperative enforcement
programs oversight; however, the States are closely involved in
this process.

Program Guidance and
Compli ance/Enforcement Pri orities

     The States through SPIRES (State FIFRA Issues. Research and
Evaluation Group) participate in the development of annual program
guidance.  Although the guidance contains national priorities,
these are only for consideration by the States as they develop

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                               - 31  -
tneir own annual  program priorities.   Specific outputs  ' ; -  zz~-
pliance/ enforcement activities ar  negotiated on  t-e  ::: j  3  or" ti
State priorities  and productivity  factors  in  t'ne  guiaa^ce.

Proaram Evaluation
     Major elements of the Regional  evaluation  of  State  programs
i nclude :

o Semiannual reports by the States  of their accomp 11 sh-ments  compared
  to the  types and numbers of inspections  projected  in  the  grant
  agreement.

o Midyear and end of year on-site  evaluation based  on  a  uniform
  evaluation protocol  which contains both  quantitative  and  qualita-
  tive evaluation factors.  The States are given  an  opportunity to
  review  evaluation reports before  they become  final.

o Training and close informal review of the quality  of  State  
  acti vities.

     The  effectiveness of a State  program  is judged  primarily on  .
the quality of its priority setting  system, its adherence  to
negotiated number of outputs, the  quality  of its  inspections  and
the adequacy of its enforcement responses.

Feceral Program in Non-Cooperative  Agreement  States

     In Colorado, Nebraska, and Wyoming,  EPA conducts  the  entire
Federal enforcement program.  The  Regions  use  the  same  priority
setting mechanism used by States  with cooperative  agreements  to
allocate  resources, conduct all inspections and take enforcement
acti ons.

     EPA  will continue its efforts  to persuade  these States  to
participate in the Cooperative Program.

Cooperative Certification and Training Program

Certification and Training Activities

     Currently all States but two have approved and  operating State
pesticide applicator certification  plans.   All  States  with  the
exception of Colorado have applicator training  programs  administered
by their  State Cooperative Extension Service in accordance  with
FIFRA 23.  Ten Indian tribes have  received EPA funds  to develop
Certification Programs,  Under rh  C 4 T prograa.  over  1.6 million
private applicators and 496,000 commercial applicators  have  been
certified and trained.  As of September 1982.  there  were over
600.000 private applicators and over 266,000 commercial  applicators
recertified.

-------
                               - 32 -


     EPA will continue to conduct certification prc:-^~3   ?  Statesi
w i t h o u t c e ~ t i  i c a t i o n plans.  3 c t h E ? A and States  ; c i : =  : - a i n -; -: -
material and  Information to ensure mat applicators a   3.-
-------
                               - 33 -

U a j a t a of Materials
w
     The core manual and various category manuals
updated to reflect changing needs and technology.  Corses of the
manuals will ae printed by che State Cooperative Extension Services
(SCES).  These and other training materials will 2-2 cataloged at
the U.SDA 3eltsville library using EPA funding.  T'->e problem continues
to be future availability of copies.  Neither the Government Printing
Office or the Department of Commerce will maintain copies of these
publications for distribution and sale.  Therefore, while copies
can be reviewed at the Beltsville library, a user can only print
his own copies from a camera ready copy, or if the timing is correct,
order from a SCES which is a.bo.ut tJ3 make a printing run.  SCES's
do not usually maintain an inventory of copies for sale.  Therefore,
the problem is not so much updating training material,  but making
it available when requested to groups other than the SCES's.

Indi an Tri be s
     Ten Indian tribes have received EPA funding assistance to
develop certification plans and some draft Indian plans are nojw
being reviewed.  Therefore, while some tribes will  probably ha've
approved plans, others will not.  EPA must then urge these tribes
to enter into an arrangement with States to perform certification
on the reservations or EPA must establish Indian certification
programs.  There is also the possibility of some split options,
such as, States issuing certificates and E3A enforcing misuse  and
denial, suspension or revocation of certification.

Re view Plans

     A more complex and long-term proposal is ttre review of all
existing certification plans for adherence to current standards.
Currently limited resources preclude such an evaluation.

Colorado and Nebraska
     Efforts will continue to be made to have thase States
develop and submit certification plans.  Colorado has recently
indicated its Interest in developing a program which will  initially
address only commercial applicators.  The Nebraska State Cooperative
Extension Service has provided training since the program began,
and this should prove an asset in the effort to have the Nebraska
Department of Agriculture develop a certification program.

Federal Facilities   	
       Federal agencies can have their employees certified under
State or EPA administered certification programs.  Most Federal
agencies chose this option, even though it imposes geographic
limitations cm wtere tfce applicator can apply pesticides, I.e.,
th State Issuing the certificate or States with reciprocal
agreements.  However, because some Federal applicators must work
1 it sever*! States, ofte-n on sliort notice. EPA allows Federal

-------
                                -  34  -
agencies  to  develop  certification  plans for tneir e-oo/ees.
Applicators  certified  under Federal  agency plans cai aro'y
pesticides anywhare,  but  this  certification is limits': to of fid a
auty  functions.   To  date, three Federal agencies, DOG, USDA anc
DOI,  have approved Federal agency  certification plans.

Cross Program Elements	

      The  pesticide program impacts  regulations and enforcement of
other State  and  Federal envi ro-rrmental  statutes.  There is a need
to  1) establish  a better  and more  formal referral program, and 2)
to  develop a mechanism to educate  inspectors on the various pro-
gram  requirements in  order for them  to effectively ma
-------
                               - 35 -
     Pesticides are a major constituent of the .vaszes at a large
number of hazardous waste sites and information on registrants
ana producers  is needed for clean-up cost recovery and associates
enforcement actions.  Information on oesticide manufacturers 133
been provided  to the Office of Waste Programs n-"o r cement as part
of the Agency's dioxin monitoring arogram.

     For pesticides listed as hazardous wastes under Resource
Conservation and Recovery Act (RCRA), disposal of the pesticide
and/or empty container is directly regulated under RCRA,  Investi-
gations and cases involving illegal disposal of RCRA regulated
pesticides identified under FIFRA or associated State enforcement
programs requires close cooperation with State and Federal RCRA
personnel.  Pesticide investigations may also provide information
on disposal practices which point to the need for regulation under
RCRA.

Water Program

     Use of pesticides resulting in drift into water is primarily
a FIFRA and State pesticide enforcement function having a direct
interface with Water Quality Criteria established by the Wat*"
Programs.  Pesticide contamination of groundwatsr resulting from
pesticide use  also requires coordination between tne pesticides
and water programs.

InterAaencv
Data Audits/Good laboratory
Practice Inspections

     As discussed on page 10, FDA conducts inspections for EPA
at laboratories which conduct health effects studies.

Soray Programs

     As discussed on page 28 under Federal Facilities. EPA/States
have monitored spray programs conducted by USDA and the 001.

Efficacy Testing

     As discussed on page 11, EPA has coordinated with FDA, USDA,
DOI, and the Bureau of Standards to have testing conducted on
ultrasonic devices, electromagnetic devices, and rodenticides.

-------
                                -  JO  -

C  & T

     ?A  w o r K s  with  other  "ederal Agencies  o" tne:-  - e -j u e s t i i
the development  and  implementation of C i 7 procrans.  Cjrre.itly
DOD, USDA,  and  DOI's Bureau  of-Land  Management -, a / e  a o p r o / e d C 3 ~
programs.

Food C:.-?t3^1 nation

     USDA an-d FDA monitor  pesticide  residues  in food.  Botn
agencies  forward  reports on  food  contamination by pesticides
to EPA for  followup  investigation, if appropriate.

Referrals and Information  Exchange

     EPA  coordinates with  USDA, FDA, DOI, FTC, CPSC, and the
U.S. Postal Service  on  several  specific types of products/devices
that are  of mutual interest.

Program tva1uation

     A system for evaluating the  effectiveness of the FIFRA com-
pliance/enforcement  program must  define specific areas for evaluatio,
measures  of program  success and mechanisms  for performing the
evaluation.  The Agency can best  measure its  success in achiev
compliance *nen  it has  developed  1)  an aaequate aata oase for
identifying members  of  the regulated community and 2) predict:
models designed  to select  those -nenbers most  1i
-------
Compliance by ttve Regulated Co-nreu rv ty	

     The extant of conp" i an ca for  tie "egulatec ::"":-"!:/  -iay  oe
measured to a limited degree by tie  fallowing factors:

o Number of applicators trained and  certified.
o Proportionate number of  estaolisnments known to oe in compliance.
o Proportionate nunoer of  applicators known to oe in compliance.
o Proportionate number of  laboratories known to oe in compliance.
o Trends in major types of violations.

evaluation Mechanisms	

     Th-e major mechanisms  to txe u.sed in program evaluation are
the f ol1owi ng:

o FATES.  The FIFRA and TSCA Enforcement System contains data  on
  inspections and sampling, case  development, grants and contract
  inspections.  This data  will  be  analyzed to determine whetner
  program commitments were met.  The FATES system should be modified
  to include State data and to  generate descriptive information
  which  could be used to  better target inspection areas based* on  an
  analysis of major types  of violations and violation trends., How-
  ever such a modification cannot  be implemented without additional
  resources.  In FY86, CMS plans  to  request funding to incorporate
  State  data into FATES.

o *4 id -year and enrf of year State  program reviews.  As discussed
  on page 31, these reviews/evaluations are based on a uniform
  evaluation protocol wnic." contains iot.i quantitative anc.
  qualitative evaluation  factors.

o Regional Reviews.  A team of  Headquarters and Regional personnel
  visits each Region avary two  years to conduct a thorough program
  review.  The review concentrates on Regional program organization;
  performance of outputs;  adherence  to national guidance in th
  performance of inspections and  development of cases; and the
  need for improved/expanded Headquarters support of Regional
  activities in specific  areas.

       Approximately four weeks after the on-site review,  Head-
  quarters submits a written report  to the Region covering all
  program elements that were part  of the review.  The report notes
  bot-h posltlv-e and negative aspects of the Region's pesticides
  compliance/enforcement  program and includes recommendations  for
  changes to be Implemented by  the Region and Headquarters.  The
  Director of the Compliance Monitoring Staff conducts a follow-up
  visit  with the Regional  Administrator to go over any issues  raised
  by the review which require further discussion.

o Periodic review of overall program based on review of FATES  data
  and State and Regional  reviews.   In order to effectively evaluate
  the program, 1t 1s necessary  to  review the program in its entirety

-------
                             - 33 -


Program Modification	
       EPA uses  aata  from FATES, State Program 3av:-w3, 3 e ;'ona :
reviews and the  overall program review, to mod:*;' t">e ZOTC1'2 ice '
enforcement program as necesary and to give input to OP cofcerr'ic
regulatory cnangs necessary to facilitate comoliance monitoring,
enforcement, or  compliance.

F u t U r e 3 u i 3.a n c a

     The following is a list of guidance documents currently  under
development or consideration.*

o -FY85 Cooperative Agre-ement Guidance.  This document will modify
  C 4 T al1ocations,  specific instructions on transferring enforce-
  ment priorities to  the CAT programs, evaluation of the CAT
  program plans  and training materials, and improved productivity
  factors for negotiating grant outputs.

o FIFRA Compliance Program Policy Compendium further defines  the
  requirements of FIFRA regulations.  Currently there are twenty
  such policies  in the compendium and three under review by  the
  Regions, the States (through SFIREG), and the progra'm office.

o FIFRA Inspection Manual provides information on conducting  insoec-
  t i o n s , col 1 acti ngsamp"es, thain-of-custody procedures, p~ep.|jfcpg
  suoport documents,  and other information necessary to conduc^^
  FIFRA inspections..  This document snould be revised if resources
  are avai Table.

o C!~RA Enforce Trent Response Policy.  Several additions tT tne
  originalpenalty policy have been developed over the years  to
  reflect amendments  to the law.  These will all be combined  into
  one comprehensive document.

a FTFRA Compliance Strategies.  The FIFRA Compliance Strategies are
  developed for  all rules promulgated under FIFRA.  A compliance
  strategy identifies the (a) requirements of the regulation, (b)
  the type of actions which are appropriate for the violation, (c)
  the inspection scheme (from which the regulated community  is
  targetted), and (d) allocation of responsibilities between  Head-
  quarters and the Regions.

o Quality Assurance Plan Development Guidance  When manuals  are
  updated, and as resources are available, CMS will coordinate
  with the Office of  Research and Development's Quality Assurance
  Management Staff and tne NIC in developing a modl Quality
  Assurance Plan- for  use by the States 1n developing individual
  Quality Assurance Plans.  States receiving Federal funds for
  compliance monitoring must submit Quality Assurance Plans  to EPA
  annually.
    A comprehensive  list of existing compliance/enforcement guidance
    docyments 1s Included 1n tne Appendix trf tne FIFRA Cowpliasca/
    Enforcement Guidance.

-------
- 39 -
   APPENDIX

-------
                                                                   FLOW
                                              NEUTRAL
                                                  IFOR CAUSE]
                        NO
                      ACTION
                                            J.
                                         
                                     -{COMPLIANCE]
                                                                       ( 30 days to deteynl ne  coinpl Jance/nuncompl lance)
                                                                                              ~~
                                            (60 days to prepare action)
                               | ADMINISTRATIVE ACTIONS")
                                                                      |  JUDICIAL..ACTIONS)
.


[1C

EOF
t
NdTlC
HARN
t
E OF
INfl_

ADVERTISING (TERMINATION
. LETTER 1 lESTAIL, REQ.J
"1 T
ACTION IAKEN
ON APPLICATOR
CERTIFICATE
I
IRITAILS]


STOP SALE
USE OK
REMOVAL
ORDER
1

CIVIL ADM.
PENALTIES

[mill/If 11 SFlZURFl
1
1 	 k .' 	

/
J
--". M

                                                                                                                CRIMINAL
                                                                                                               I PROCEED ING
REMEDIAL
                ACT
OH
             CAGE Hi! r
             (IMPlAjflj
                                                                        ftKS. ATTORNEY |
                                                                   UEPT.  OF
                                                                   JUST 1C F
                                                                                                 ArflOtjJ
(DEFAULT)
  NO
ACTION
                           DEFAULT
                            ORDER
                                                                      [ALJ
                                                         CrilllSENlT]
                                                         1,1/11 ni Nil
                                                          _-,_.__^_l
                                                        HEARING]
                                                                   -4            ,	,
                                                                u.s.  i)isT7~couTf>|NOT GUILTY)
                                                    INITIAL
                                                    DECISION
                                                FINAL
                                                ORDER
                                       (NOT!
                                       I CUIlTYf
                                                                           I
                                          [ UPHELDk
                               APPEAL TO
                              ADMINISTRATOR
                                                                                    | UPHELD
                                                                        JfTu.s.
                                                            SUPREME
                                                           COURT
                                                                                         iUII-
                                            ^REINSPEci^
  ^Determinations of complIance/noncanplIancei are dependent  upon   receipt of  all documentation  and  cmnpletlon  of  all
   Sample Analyses.  Action preparation Is dependent upon  ((.'solution  of  any new policy  issues iirt;si:iih>
-------
 t'
5 nTsi
                      Ml  [
ENFOHCFMI w AI noir, TTTsui TING FROM GRANT INSPECTIONS
              I till   ACCOfU'llSIIMENTS
               HKilDII     National

ENFORCEMENT
ACCOMPLI SIUC NTS
i
)_._.. ___. j
.
Inspections
i
Civil Actions
Criminal Actions
Administrative
Hear Inns
LIconso/Cort 1 1 Icata
Suspension '
License/Certificate
Revocation
License/Cert II lea to
Conditioning or
Modification
Ntimbor oi Cases
Issued Warnings
Ston-^Sale, Seizure,
Quarantine or Embaryo
Cases Forwariled to
EPA for Action
Other Enforcement
Actions ,
BBaasaaMaa*aaacssaaua=a
Total Numbor of
Actionable Inspections
Percent of inspections
Result Inn In Action
Petcont of total
Actions (8712)
Nufnbqr of Casos
Assessed Finos
AGrtlCU
Use
2,923
19
2
16
1
M
8
366
24
II
\
0
lascaaai
451
19.4
5.2
laoscaqi
12
TURAL
Misuse
3,675
70
47
76
33
126
17
	 366
17
22
43
i a an aatMt
017
22.2
9.4
laKMSBdC
59
imNAGRICIiUmAI
IJ,o
4,631
7
20
21
II
10
24
694
62
4
25
870
IB. 9
10. 1
;aao;assa
9
Ml SUM)
IA00/
	 IMi
II
(>'.
li
(t
'1
412
21
2'
til
(I'K,
4(>.U
J.7
E a S- a 3 :.;;::.
...'/?
ixr ur,r
INSP
M)4
20
0
0
0
()
	 0
16
3
3
0
4?
10.9
0.5
M
PRODUCE
ISIAIl
2j6'J3
30
5
25
0
3
2
402
77
119
""" H7
750
20.3
O.l)
- '30
MARKET-
PLACE
12,522
142
1
57
3
0
3
620
1032
163
970
2991
23.9
34.4
,J
IM-
PORTS
523
6
0
2
0
0
0
1
0
0
10
19
3.6
0.2
. =: casrss a
l
CEHTIFIEIl
API 'LICK
RECORDS
IIJ75
159
90
67
502
/

70<

7
2
1561
13.9
17.9

RES1K4CIID
IISI PI SI
DIAIIRS
9,1111
44
0
14
2
1
0
219
50
0
9
VI /
>.'
'1.0
22
101 AI
50,104
665
242
343
565
106
i
57
3002
J30I
354
1197
07 1 2
| 7. 4
100
424

-------
                         ENFORCEMENT ACTIONS
                                        FV02
lAfllE  
lit MIL 11 H<;  HIOM GRANT INSPECTIONS
ACCOMl'l |SIIIII NFS
    HA i KIIIAI
ENFORCEMENT
ACCOMPLISHMENTS
Inspection*
Civil Actions
Criminal Actions
Administrative
w tarings
reuse/Certificate
*>j sponsion
License/Certificate
Evocation
License/Certificate
"ontht lout tig or
lidhtcatton
iniliof of Cases
Issuud Marftlngs
Stop-Sale, Seizure,
l^iarantlne or Embargo
r.ases Forwarded to
[PA for Action
Jllicr Enforcement
Vet Ions
total Number of
let 1 enable Inspections
'erctht of Inspections
^suiting In Action
Vrcinl of Total
V lions (J764)
liimhi-r of^fees
Visessed M
AGRICULTURAL
Use '
4,841
22
2
20

1
n
123
in
9
51
tammmmxti
254
5.2
3.3
10
Misbse
2,401
26
15
59
29
5
13
471
12
10
17
657
27.4
0.5
25
TiffllATlRl
Use
4,962
20
41
43
7
in
3
666
30
10
173
laasaaai
1,027
20.7
13,2
-uaxmst
5
CUTURAL
Misuse
1,792
27
152
175
21
35
3
406
54
5
5?
IKCHr BBC i
t
930
51.9
12.0
maaaa sz:
105
rxFiisi
IHSI'
313






1

311
31
9.-J
n.4
fitohiicr
1 SI All
2,339
2
1
14



237
116
69
14
4/3
20.2
6.1
n
HABIT
PLACE
15,932
10
5
57


1
505
1 ,024
04
940
2,706
17.0
^4.11
6
TMT-
POIUS
174






3
1
4
: - a a a 3 s :
0
4.6
O.I
0
CERTIFIED
APPLICR
HECORDS
14,700
7
5
27
140
'I
2
742
5
2
102
1,011
7.1
13.4

ItTSlRllUI)
USE I'EST
DEALEKS
11,779
5

11
11


210
119

.;;
491
4.2
6.3
II
* ,
76
1

i



17
124
1
3
:~.~:=L.a
Iff.
l
1.9
;j u u  to ft. -
0
TOTRT
59,317
120
221
406
216
60
30
3,469
1,531
224
1,479
i v a u  x: s
7,764
13.1
1(10
*.iirn*.
I'JO
  I

-------
FEDERAL PESTICIDE COMPLIANCE INSPECTIONS

Producer Establishment
I nspect i ons
Use Investigations
Marketplace Inspections
Import Inspections
Dealer Inspections
Laboratory Audits/
Inspecti ons
TOTALS
CV79

443
482
1115
332
359

17
2803
rv3C -'a- r,2 rv=3 -

234 257 235 151
559 435 414 124
320 291 233 210
494 241 306 301
955 945 719 0

8 413 25
2621 2254 2021 821
2nc Quarter r'icZ Tczais

-------
 TOE3AL  PESTICIDE ENFORCEMENT ACTIONS

Civil Co^oTaints
Initiated
Criminal ^5~2rrals
Initiates
Stop Sale, Use, Removal
Orders
Notices of Warning
Inport Detantions
TOTALS
r v 7 3
.
252

2

479 2J
507
91
1332
r v 3 o - v .3 '

i 75 151

a 0

113 105
831 429
70 71
1194 755


 ^ 2.1

2 '

50 42
855 1270
53 11
1137 1545
I/ Second Quarter FY83 Totals
T/ An additional 24,000 Stop Sale Orders were issued  to  firms  t
   held susoended 2,4,5-T and Silvex products.

-------
  o*C
             UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                         WASHINGTON, D.C. 30460
                             JAN 151985
                                                           OFFICE OF
                                                   PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM
SUBJECT:  Final GLP Compliance Strategy

FROM:     A. E. Conroy II, Director
          Office of Compliance MonitoringfEN-342 )

TO:       Addressees


     Attached for your information is the final compliance
strategy for the Good Laboratory Practice (GLP) regulations (also  .
attached) published on November 29, 1983 (48 FR_ 53922).  The
rules became effective on December 29, 1983 for the Toxic
Substances Control  Act (TSCA) and on May 2, 1984 for the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA).  The Office
of Compliance Monitoring (OCM) is now evaluating comments on the
TSCA GLP enforcement response policy (ERP)  and the final ERP is
expected to be completed during the second  quarter of FY 85.

     We appreciate the time and effort spent by the various program
offices and regions in reviewing this document.  OCM received
several editorial comments regarding the compliance strategy
which has helped to clarify portions of the final  policy.  While
all the comments received were reviewed, all comments were not
incorporated into the final policy.  Responses to the most
significant comments are provided below.

Comment 1-  For large commercial  laboratories and/or complex
studies, two days notice prior to inspection is unrealistic.
Recommend two weeks.  Without adequate notice... personnel and
key data... (may not be) readily availaole.

Response-  The GLP regulations have provided adequate notice to
all persons, 1n the section for storage and retrieval of records
and data, that there shall  be archives for  orderly storage and
expedient retrieval of all  raw data and documentation.  Persons
will  be in violation of the GLP regulations when not complying
with this provision.  Two days has generally been accepted as
adequate notification by the other commentors and OCM staff.

-------
                               -2-


Comment 2-  OTS has  noted that "some data submitted with PMNs
have stated that  studies were done according to GLPs (usually
OECD GLPs).  However, protocols are often missing, test
substances are inadequately defined, and there are other
deviations from any  known GLPs.  OTS recommends that claims that
data were in accordance with GLPs not be allowed unless the data
reports are sufficiently detailed to support the claim.  As a GLP
compliance issue, this recommendation should be considered by
OCM."

Response-  OCM does  not have the authority to restrict persons
from making claims such as described above.  OTS could remedy
this by amending  the PMN rule requiring submitters to 1) provide
statements with PMNs indicating whether the submitted studies
adhere to the GLPs and 2) support such claims with sufficiently
detailed reports.  When OTS has concerns with specific data and
compliance with the  GLPs, OTS should provide OCM a list of
studies supporting PMNs and the names of the labs.  OCM can then
schedule inspections/audits at the laboratory.

Comment 3-  OPP recommends that the "quality assurance unit
establish written procedures which it would follow in conducting
inspections."  OPP justifies this request by stating that section
160.35(d) of the  FIFRA GLP regulations does not clearly identify
who is responsible for writing the procedures.

Response-  OCM agrees that such language is needed.  However,
OCM does not have the authority to require this in the GLP
strategy unless it first appears in the GLP regulation.  OCM
suggests that OPP propose an amendment to the regulation
regarding this subject.

Comment 4-  OPP recommends that the GLP strategy indicate that
management communicate deviations from the regulations "in
writing" to EPA because the GLP regulations do not specify the
means of communication.

Response-  Same response as for comment 3.

     If you have  any questions concerning this memorandum, please
call Richard Green of my staff at (202) 382-7845.


Attachments

Addressees

Marcia Willia-ns      Air and Waste Management Division Directors
Don Clay             Environmental Services Division Directors
Steven Schatzow      Regional Toxics and Pesticides Branch Chiefs
Terrell Hunt         Office of Regional Counsel
Ruth Bel 1
Jim McCormick

-------
   Strategy for the Enforcement of the Good Laboratory Practice
                 Regulations Under TSCA and FIFRA
0vervi ew

     On November 29, 1983, the Environmental  Protection Agency
(EPA) published final  rules establishing Good Laboratory Prac-
tice (GLP) standards for the conduct of laboratory studies that
are used to obtain data for hazard evaluations under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Federal
Food, Drug, and Cosmetic Act (FFDCA) ,  and the Toxic Substances
Control Act (TSCA).  The GLP regulations became effective on
December 29, 1983 for  TSCA and on May  2, 1984 for FIFRA.  They
were the result of investigations by the Food and Drug Adminis-
tration (FDA)  and EPA  which showed that some  studies submitted
in support of  the safety of regulated  products and pesticides
had not been conducted in accordance with acceptable practice,
and that, accordingly, the quality and integrity of such studies
were not always adequate.  In conjunction with EPA's new data
audit efforts, the regulations are intended to ensure the high
quality of laboratory  test data required to evaluate the health
and environmental effects of regulated chemical substances and
pesti cides.

     The Assistant Administrator for Pesticides and Toxic Sub-
stances has established a Laboratory Data Integrity Program
(LDIP) within  the Office of Compliance Monitoring (OCM) which
combines the GLP inspection program with EPA's data audit program
OCM, the Office of Pesticide Programs  (OPP),  and the Office of
Toxic Substances (OTS) are charged with cooperating in the
development and conduct of an effective laboratory inspection
and data audit program.
Requirements of the Rule

Appli cabi1ity

     The GLP regulations apply to any study conducted, initiated,
or supported on or after the effective dates of the rules that
relate to health effects, *nvi ronmental  effects, and chemical
fate testing under TSCA arid studies (as  defined by section
160.3(m) of the FIFRA GLPs) that support or are intended to
support applications for research or marketing permits for
pesticide products regulated by EPA.  By their terms the rules
apply  to studies related to TSCA Section 4 Test Rules, under
FIFRA to Section 3 'applications for registration), Section 5
(experimental use permits), Section 18 (emergency exemptions),
and Section 24(c) (registrations for special local needs), and
under  FFDCA to Section 408 (tolerances for pesticide residues  on
raw agricultural commodities) and Section 409 (food additive
regulations) .

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                               -2-

     In addition, under TSCA the Agency will  require sponsors to
utilize the GLP standards When conducting testing under negotiated
testing agreements.  Agency policy also requires that all  data
developed as a result of regulations or orders under Section 5
of TSCA must be in accordance with GLP standards.  Any failure
to adhere to GLP standards in generating data under negotiated
testing agreements or under Section 5 of TSCA may result in the
Agency's electing to consider such data insufficient to evaluate
the health effects, environmental effects, and fate of the chemical

Specific Requirements of the GLP Regulations

     The requirements of the GLP regulations  are contained in
40 CFR Part 160 (48 F_R 53946, November 29, 1983) and 40 CFR
Part 792 (48 F_R 53922, November 29, 1983).  Generally, the rules
contain provi sTo nsrelatingto:

          (1) General Provisions;
          (2) Organization and Personnel;
          (3) Facilities;
          (4) Equipment;
          (5) Testing Facilities Operation;
          (6) Test and Control Substances;
          (7) Study Protocols; and
          (8) Records and Reports.


     (1) General Provisions (Subpart A).

     Subpart A contains a number of key provisions that are
designed to promote an awareness of GLP requirements on the
part of all  persons involved in the testing process.  First, the
rules require that a sponsor must notify of the GLP regulations'
applicability any laboratory that performs all or part of  a
study that is subject to the regulations.

     Second, any person who submits data from a study in connec-
tion with a TSCA Section 4 test rule or an application for a
research or marketing permit must include in  the submission a
statement signed by the applicant, the sponsor, and the study
director, of one of the following types:

     (a) A statement that the study was conducted in accordance
with the GLP regulations;

     (b) A statement describing in detail all differences  between
the practices itsed  n the study and those required by the  GLP
regulations; or

     (c) A statement that the person was not  a sponsor of  the
study, did not conduct the study, and does not know whether
the study was conducted in accordance with the GLP regulations.

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                               -3-

     Finally, Subpart A details the sanctions available to the
Agency that are in addition to the imposition of civil and crimi-
nal penalties.  For example, EPA may choose not to consider
reliable for purposes of showing that a chemical does not present
a risk of injury to health or the environment any study which 
was not conducted in accordance with GLP requirements.  Any
determination that a study will not be considered reliable will
not relieve the sponsor of a required test of the obligation
under any applicable statute or regulation to submit the results
of the study to EPA.  EPA may also require the sponsor of data
submitted under a TSCA Section 4 test rule to develop data in
accordance with GLP requirements where he or she failed to do so
inaprevioussubmission.


     (2) Organization and Personnel (Subpart B).

          (a) Personnel (Sections 160.29 and 792.29).

     While specific qualifications are not required of laboratory
personnel, the rules generally require facilities to document
that each individual engaged in the conduct of a study has educa-
tion, training, and experience to enable that individual to
perform his or her assigned 'functions .

     Personnel are also required to take necessary personal
sanitation and health precautions to avoid contamination of test
and control substances and test systems.

          (b) Testing Facility Management (Sections 160.31 and
792.31).

     For each study, testing facility management is required to
designate as study director a scientist or other professional of
appropriate education, training, and experience.  The study
director has overall responsibility for the technical conduct of
the study, as well as for the interpretation, analysis, documen-
tation, and reporting of results, and represents the single
point of study control.

     Testing facility management is required to establish a
quality assurance unit responsible for monitoring each study to
ensure that the facilities, equipment, personnel, methods,
practices, records, and controls are in conformance with the
GLP regulations.  For any given study the quality assurance unit
must be entirely separate from and independent of the personnel
engaged in the direction and conduct of that study.

     Management is also required to ensure that test and control
substances have been properly tested for identity, strength,

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                               -4-

facilities, equipment, materials and methodologies are available'
as scheduled.  Finally, management must ensure that any deviations
from the regulations reported by the quality assurance unit  are
communicated, preferably in writing, to the study director  and
that corrective actions are taken and documented.


     (3) Facilities (Subpart C).

     Each testing facility is required to be of suitable size,
construction, and location for the proper conduct of studies.
It must be designed so that activities are sufficiently separ-
ate to prevent any adverse impacts on the study.  More detailed
requirements ensure proper facilities for:

          (a) Animal care and supplies;
          (b) Handling test and control substances;
          (c) Laboratory operation;
          (d) Specimen and data storage;  and
          (e) Administration and personnel.


     (4) Equipment (Subpart D).

     Any automatic, mechanical, or electronic equipment used
in the generation, measurement, or assessment of data, and
equipment used for facility environmental control is required
to be of appropriate design and adequate  capacity to function
according to the protocol and must be operated, inspected,
cleaned, and maintained in a suitable location.  Equipment
used for the generation, measurement, or  assessment of data
must be adequately tested, calibrated, and standardized.


     (5) Testing Facilities Operation (Subpart E).

     A testing facility is required to have standard operating
procedures (SOPs) in writing that set forth study methods
adequate to ensure the quality and integrity of the data generated
in the course of a study.  Any deviations must be authorized and
documented.  SOPs are required for most facets of a study.


     (6) Test and Control Substances (Subpart F).

     The identity, strength, purity, and  composition, and any
other characteristics which will appropriately define the test
or control substance, must be determined  for each batch and  be
documented before the study is initiated.  The sponsor or testing
facility must document all methods of synthesis, fabrication,
derivation of the test and control substances and must

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                               -5-

that they are stable,  properly labeled,  stored,  and  handled  in
such a way as to prevent contamination,  deterioration,  or  damage.
The receipt and distribution  of each  batch  must  be documented
and reserve samples retained.

     For each test or  control  substance  that  is  mixed with a
carrier, tests must be conducted to determine  the mixture's
uniformity, concentration,  and stability.   The expiration  date
of any components of the mixture must  be shown clearly  on  the
contai ner.


     (7) Study Protocol  (Subpart G).

     Each study is required to be conducted in accordance  with
an approved protocol that clearly indicates the  objectives and
all methods for the conduct of the  study.   Any changes  in  an
approved protocol must be explained,  documented, signed  and
dated by the study director,  and maintained with the protocol.


     (8) Records and Reports  (Subpart  J).

     A final report must be prepared  for each  study, signed
and dated by the study director, and  maintained  by  the  sponsor
and the testing facility.  In  addition,  all  raw data, documen-
tation, records, protocols, specimens, and  final reports generated
as a result of a study must be retained  and archived for orderly
storage and expedient  retrieval.  This includes  correspondence
and other documents relating  to the conduct,  interpretation, and
evaluation of data.


     (9) Environmental Testing (Subpart  L - TSCA only).

     The TSCA 6LP regulations  contain  special  provisions that
adapt the regulations  to environmental studies.   The FIFRA GLP
regulations contain no corresponding  subpart.
Regulated Community

     The regulated community consists of those who sponsor and
submit tests that are subject to the GLP regulations and the
laboratories that conduct such tests (see Appli cabi1ity, above)

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                               -6-

E nforcement


Objecti ve

     The objective of this strategy is to maximize compliance
with the GLP regulations in order to promote the high  quality  of
laboratory test data necessary to evaluate the health  and  environ-
mental effects of regulated chemical substances  under  TSCA and
pesticides under FIFRA.


Vi olati ons

     Generally, the failure to comply with any requirement of  the
GLP regulations is a violation of those regulations (see  Speci fi c
Requirements of the GLP Regulations, above).  However, violations
are actionable in a different manner under FIFRA than  under
TSCA, since, unlike TSCA, FIFRA does not provide that  it  is
unlawful to violate a regulation promulgated under its authority.
Accordingly, a violation of the GLP regulations  is not necessarily
a violation of FIFRA.  Exceptions are where falsification  is
committed knowingly within the meaning of Section 12(a)(2)(m)  of
FIFRA, and where records are not maintained as required by FIFRA
The FIFRA GLP regulations provide further that EPA may refuse
to consider reliable for purposes of supporting  an application
for a research or marketing permit any data from a study  which
was not conducted in accordance with the GLP regulations.

     In addition, the submission of a false statement  under the
certification provisions of the GLP regulations  may form  the
basis for cancellation, suspension, or modification of a  research
or marketing permit, or denial or disapproval  of an application
for such a permit under Sections 3, 5, 6, 13,  or 24 of FIFRA  or
Sections 408 or 409 of FFDCA, for criminal prosecution under
18 U.S.C. 2 or 1001 or Section 14 of FIFRA, or for imposition  of
civil penalties under Section 14 of FIFRA.

     Similar sanctions are contained in the TSCA GLP regulations,
except that the failure to comply with the TSCA  GLP regulations
is a violation of Section 15 of TSCA.  Violations are  therefore
subject to the sanctions contained in that section.


Inspection Scheme

     EPA, with t'e assistance of the Food and  Drug Administration
(FDA) and the National Toxicology Program (NTP), will  use  a
Neutral Administrative Inspection Scheme (NAIS)  for laboratories
that have conducted or are conducting health effects studies

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                               -7-

that are subject to the GLP regulations.  The responsibilities
of FDA and NTP are set forth in two interagency agreements.
Laboratories conducting environmental  effects studies will  be
addressed similarly, but only EPA will  be involved in these
since FDA and NTP do not review studies of this type.

     The GLP regulations require testing facilities to permit
EPA inspections at reasonable times and in a reasonable manner.
EPA believes that the possibility of unannounced inspections
motivates compliance and efficiently uses resources.  Generally,
however, EPA will notify laboratories  up to two days before
an inspection in order to ensure the availability of appropriate
personnel and records.  Once EPA notifies a laboratory, it  will
not change the date of the inspection  unless the laboratory
demonstrates unusual  circumstances and  good cause.  EPA will
coordinate with FDA and NTP to avoid multiple inspections at
the same faci1i ty.

     The NAIS will consist of two major categories of inspections:
GLP inspections and data audits.  Inspections within both of
these categories normally will be conducted on the basis of
objective criteria or random selection.  However, inspections
may be targeted for cause at certain facilities where:  1)  major
problems were discovered during a previous inspection that  might
affect the validity of unaudited studies; 2) EPA receives tips
(i.e., phone calls and letters from various sources, and
information provided by OPP or OTS based on their ongoing reviews
which OCM will review for validity and  significance to determine
the level of priority for enforcement  action), complaints,  or
other information indicating that a particular laboratory is in
violation of the GLP regulations; or 3) a particular study  is
assigned a high priority because it is  expected to form the
basis for major regulatory action.

     GLP inspections are laboratory-oriented and will focus on
a facility's compliance with the GLP regulations.  They will
usually include partial audits of at least two ongoing studies.
GLP inspections will  be scheduled by OCM and carried out by
Regional inspectors and FDA.  NTP, at  OCM's request, will provide
assistance when OCM personnel lack specific expertise.

     A data audit is stu-jy-ori ented and is the process by which
EPA verifies that the data from a completed laboratory study are
consistent with the final report that  was submitted to the  Agency.
This is accomplished by examining raw  data and other records
generated during the study and comparing them with results  provided
in the study report.  Data audits will  be scheduled and carried
out by OCM, with necessary assistance  provided by FDA, NTP,
Program Offices, and the Regions.

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                                -8-

      Ideally, EPA  should  inspect  regularly every laboratory that
conducts EPA-related  studies  and  should audit every study that
has been (or will  be)  submitted to  EPA in support of the safety
of regulated substances.   However,  in the event that EPA's re-
sources do not  permit  such  complete coverage of the regulated
community, EPA  will apply  the  following criteria to the conduct
of inspections:


      GLP Inspections/Partial  Study  Audits:  EPA will assign
      priority to the  estimated 90-100 laboratories that conduct
      90 percent of EPA-related testing.  EPA plans to conduct
      inspections on a  periodic basis at every laboratory
      conducting testing under  TSCA  and FIFRA.  Priority will  be
      assigned to testing  laboratories with greatest number of
      studies performed under  TSCA and FIFRA and those who
      initiate testing  under TSCA or FIFRA for the first time.
      The frequency of  these inspections will  depend upon
      available  resources  and  will be geared towards visiting  labs
      to inspect the full  gamut of studies (acute, subchronic  and
      chronic),  if  possible.

      Data Audits:  EPA will assign  priority to studies based
      upon the known need  of the specific program to form the
      basis for  major  regulatory action.  EPA will also assign
      priority to studies  known to be or suspected of being in
      violation  of  FIFRA or  TSCA.  High priority studies often
      will be the subject  of both a GLP inspection/partial study
      audit while they  are  ongoing and an audit after completion.
      Studies that  were not  required to be conducted in accordance
      with the GLP  regulations  normally will  be targeted for
      audit by the  Program Offices.

      Within both of these categories, EPA will  assign the highest
priority to responding to tips, complaints, and other information
indicating that violations  of  the GLP regulations exist.


Violation Detection Priorities

     The requirements  of  the  GLP regulations  may be separated
into two categories:   (1) those directly related to the actual
conduct of a study; and (2) laboratory housekeeping requirements.
EPA will assign a  higher  priority to violations in the former
category.  However, some  overlap between these categories may
be expected.  Wnere this occurs, the guiding  consideration becomes
the degree to which a  given violation may compromise the validity
of a study.  For example, a violation of the  recordkeeping require-
ments would ostensibly fall within the housekeeping category.
Nevertheless, the  lack of records may prevent EPA from determining
that a study's  results are  valid and would therefore be given a
higher priority.

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                               -9-


Adnrinlstrative Considerations

     The attached Memorandum of Agreement (MOA) between OCM,
OTS, and OPP will govern the administration of LDIP.  Generally,
the MOA establishes the LDIP Panel which will be chaired by OCM
and will include members from OPP and OTS.  The Panel will  serve
as a clearinghouse for the flow of information among participating
Offices and will periodically review LDIP policies, procedures,
and operations and recommend program changes to the Director,
OCM, who has full responsibility for implementing the program.
The Panel will serve as a steering committee to ensure that
Agency commitments and objectives are fully implemented and met.

     OCM will  have the lead in directing the program by (1)
coordinating all laboratory inspections and data audits with
OPP, OTS, and  the Regions, and by (2) acting as a liaison with
other agencies, such as FDA and NTP, which cooperate with EPA in
conducting laboratory inspections and data audits.  OCM will be
the Agency contact for scheduling FDA and EPA laboratory inspec-
tions and study audits, as well as for receiving and disseminating
audit and inspection reports to both OPP and OTS.  OCM will
monitor the status of each inspection andaudit.

     The Regional Offices will provide support for inspection
and enforcement activities as needed.  Regional responsibilities
will  include the conduct of and case development for most GLP
inspections.

     OTS and OPP will provide the scientific and regulatory
review of laboratory GLP inspection reports and data audit
reports within their respective program areas.  Program Office
scientists will recommend studies for audit and will participate
in inspections and study audits at laboratories, consistent
with resource  allocations.  They will also serve as expert
witnesses in support of Agency litigation efforts.

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                        INTERAGENCY AGREEMENT
                              BETWEEN
               THE  U.S.  ENVIRONMENTAL PROTECTION AGENCY
              OFFICE  OF  PESTICIDES AND TOXIC SUBSTANCES
                 .  '             AND
           THE  U.S.  DEPARTMENT OF HEALTH AND HUMAN SERVICES
                     NATIONAL TOXICOLOGY PROGRAM
 1.  PURPOSE
      This  agreement  provides for cooperation between the National
Toxicology  Program  (NTP) and the Environmental Protection Agency
(EPA)  in the  areas  of  inspector training, inspection operations,
data  audits and  information exchange.  This cooperation will
enhance the EPA's mandated activities designed to determine
whether laboratory  testing was performed properly and in compliance
with  Good Laboratory Practice (GLP) regulations and whether the
test  report can  be  fully validated through audits of the raw data
generated during the testing phase.
      The primary purpose of this cooperation is to utlize NTP's
experience  in conducting and reporting laboratory GLP inspections
and data audits  to  enhance the training and capabilities of EPA
personnel  in  these  activities.

2.  SCOPE OF  WORK
      The Environmental Protection Agency (EPA) is responsible
for setting tolerances for pesticide residues in  or on raw
agricultural  commodities and processed food under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.   346 and  348) and for
registering pesticides under the Federal Insecticide, Fungicide,

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                                -2-

and Rodenficide  Act  (FIFRA)(7 U.S.C. 136 et sec).  In addition,  '
EPA has- the  mandated  task under the Toxic Substances Control  Act
(TSCA) (15 U.S.C.  2601) to assure that no chemical wi11 present
an unreasonable  risk  of injury to health or the environment.
EPA regulatory decisions on such matters are based in part on the
results of toxicological testing performed by or for registration
applicants,  tolerance petitioners, and chemical manufacturers
or processors.
     This agreement,  which provides for cooperation in  the
training of  EPA  laboratory inspectors and auditors, in  providing
specific scientific  expertise as required for laboratory inspec-
tions and data audit  as well as in the sharing of information on
laboratory GLP   compliance monitoring will enable EPA to
determine (1) whether the testing was performed in accordance
with specified methodology, (2) whether any reported deviations
may have affected  the reliability of the test results,  (3) whether
the test results as  reported can be fully supported by  the raw
data generated during the study and (4) whether the testing was
carried out  in compliance with EPA's GLP regulations.  The
authority for FIFRA GLP regulations is 4U CFR Part 160  and for
TSCA is 40 CFR 792.   For studies conducted prior to this, "GLP
regulations" refers to the Food and Drug Administration's GLP
Regulations  (43  FR 59986).

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                                -3-





      Laboratories  inspected  may  be  facilities in which both EPA



 and  NTP  have  common  interests  or  they  may be.faci1ities carrying



 out  studies  applicable  only  to  the  EPA  but that the EPA finds it



 cannot  inspect  due the  to  the  lack  of  specific expertise.



      While EPA  may have  an interest in  an NTP-sponsored study,



 EPA  will  not  audit an NTP-sponsored study without the express



 approval  of NTP  management.  Studies to be audited may be either



 in progress  or  completed.





 3.   EXCHANGE  OF  INFORMATION



      Each agency will exchange  information concerning active



 inspections and  audits  of  interest  to the.other agency.



     Each  agency  will inform  the  other of legal  or administrative



 action being  considered  or taken  against any laboratory covered



 under this agreement.   This  section is  concerned with legal or



 administrative  penalties and not  with such infractions or



 deviations as can  be corrected  easily and judged to have had



 little or no  significant impact on  the  validity of  the study.





 4.   NTP'S RESPONSIBILITIES



     a.  Study Audits -  NTP  will  provide EPA's  Compliance



Monitoring Staff (CMS) with  a copy  of the final NTP audit report



 of chemicals  of  interest to  EPA;  such chemicals may have been



 originally nominated or  co-nominated by EPA for study or EPA may

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                                -4-

have  developed an  interest  in  the chemical during thetesting
phase.   NTP  will  provide  CMS  on  a quarterly basis with the
schedule  of  NTP  audits  of completed  studies to be conducted in
the next  quarter.
      b.   GLP  Compliance Monitoring -  NTP will supply CMS on a
quarterly  basis  with  an advance  schedule of site visits to be
conducted  by  NTP  in  the next  quarter.  At the request of CMS,
NTP will  provide EPA  with a copy of  the report of a site visit
of interest  to CMS.   EPA  will  not institute any enforcement
action against an  NTP-inspected  laboratory based solely on
an NTP inspection  report.
      c.   Training  -  NTP,  within  constraints of personnel and
schedules, will  detail  experienced NTP personnel who will  act
as instructors in  EPA-sponsored  courses or workshops on GLP
compliance monitoring,  data audits and related topics.  Schedules
and topics will  be worked out  cooperatively to ensure adequate
time  for  course  preparation and  review.  Such details of personnel
will  be  at no  expense to  NTP  other than salary.
      d.   Expert  Inspections -  NTP, at the request of CMS,  and
within the constraints  of personnel  and schedules,  will detail
expert personnel to  accompany  a CMS  inspector or EPA audit team
when  EPA  is unable to inspect  a  testing laboratory  or complete a
data  audit because of the lack of specific expertise.  CMS will
provide the  -equef.ted scheduling in  advance to NTP  along with
all non-confidential  information on  the laboratory  and study(ies)
necessary  to  prepare  for  a  compliance inspection.

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                                -5-

 NTP personnel  in this situation will be advisory to the CMS
 inspector, who  has the responsibility for conducting the
 inspection or  audit and preparing the report of the inspection
 or audit.  The NTP personnel's  advisory report of findings will
 be incorporated into the EPA inspector's report.  Wherever
 possible such  inspections will  be at no cost to NTP other than
 s a 1 a ry .
     e.  Confi denti ality - Under various provisions of FIFRA
 and TSCA, toxicology data submitted to EPA may be considered
 trade  secrets  entitled to protection from unauthorized public
 disclosure.  Such information will  not be furnished .to NTP
 personnel in advance of a laboratory inspection or a study audit.
Any requests for further disclosure of such information received
 by the NTP under the Freedom of Information Act will be referred
to the EPA for processing.  NTP personnel  will  not prepare any
 reports utilizing data which may be confidential.

5.  EPA'S RESPONSIBILITIES
     a.  List of Laboratories for Coverage - EPA will  provide NTP
with  a quarterly listing of labortories  to be visited.  This
 listing is to be provided to NTP at least 30 days in advance of
a given quarter and will include the name(s) of the faci1ity(ies )
to be  inspected, the dates of the inspections and the  EPA
scientific personnel  who will participate in the inspection
or audit.  This information will be classified as "For Official
Use Only" and shcjld not be disclosed except on a need-to-know
basis.

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                                    -6-

      EPA  will  identify  for NTP those inspections where assistance
 is  requested  from.NTP  and provide NTP with a clear definition of
 the  assistance  needed.
      In advance  of  a  laboratory inspection EPA will provide NTP
 with  a list of  EPA  studies in progress as well as test protocols,
 EPA  test  guidelines  as  available and FDA test guidelines as
 appropri ate.
      b.   Reporti ng  Format - A mutually agreed format will be
 used  by NTP in  reporting its advisory portions of EPA inspections
      c.   Studies  to  be  Audited - EPA will provide NTP with copies
 of the test protocol,  guidelines and toxicology test reports
 including  any  special  instructions which might be appropriate to
 the  study  to  be  audited.  None of the material so provided will
 be classified  as  Confidential Business Information.
      d.   Confidenti a!ity - EPA is required, under both FIFRA and
 TSCA, to  maintain confidentiality of certain test-related infor-
 mation.   EPA  will  not  provide NTP any material classified as
 FIFRA or  TSCA  "Confidential Business Information."  EPA may
 furnish NTP with  material classified as  "For Official Use Only"
which is  not  to  be  disclosed by recipient NTP personnel to others
 except on  a need-to-know basis.
      e.   NTP  Requests  - EPA will respond to all requests for
 information received by NTP under the Freedom of Information Act
which relate  to  visits  performed for EPA by NTP.

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                                -7-

      f.  Delegation of Authority - As necessary EPA will provide
to NTP  personnel  a  letter containing appropriate delegation of
authority.  This  letter will then be furnished to the management
of the  laboratory at the beginning of the visit.
      g.  Notification of Sponsor - Contracts may exist between
laboratory and sponsor prohibiting disclosure of raw data by the
laboratory without the permission of the sponsor.  In order to
ensure  that raw data are available to EPA and NTP personnel
conducting a data audit, EPA's Compliance Monitoring Staff will
notify  the sponsor of the study of the intent to audit one or two
working days preceding the scheduled visit.   CMS will exercise its
own discretion regarding advance notification to the laboratory
of the  scheduled  visit.
      h.  Evaluation of Reports - EPA will determine whether
discrepancies listed in the compliance inspection reports submitted
by NTP  personnel  or study audit reports impact on the validity of
studies.  Any administrative or regulatory actions  resulting from
these reports will be the responsibility of  EPA.
      i.  Trai ni ng Schedules - CMS will  consult with NTP on the
content and scheduling of training courses and workshops and will
jointly determine the faculty for such courses and workshops.
Both  EPA and NTP  staff will be invited to attend such courses and
workships as appropriate.

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                               -8-

6.  DURATION OF  AGREEMENT
     This  agreement will .become effective on the date of the last
signature  and shall continue in effect until September 3U, 1984,
unless modified  by mutual written consent of both parties or
terminated by either  party upon a ninety (90) day advance written
notice to  the other.  This agreement may be reviewed by written
consent of both  parties on a fiscal year basis.
7.  PROJECT OFFICERS
     For EPA:  Dr. Dexter S. Goldman (EN 342)
               Head,  Laboratory Data Integrity Program
               Compliance Monitoring Staff
               Environmental Protection Agency
               401 M  Street, S. W.
               Washington, DC  20460

     For NTP:  Dr. Bernard A. Schwetz
               Chief, Systemic Toxicology Branch
               National Toxicology Program
               National Institute of Environmental  Health Sciences
               P.O. Box 12233
               Research Triangle Park,  NC  27709
8.  FUNDING
     No transfer of funrio is necessary under this agreement.   Each
agency will fund its  part of cooperative actions.  EPA will  fund
travel and travel associated expenses of NTP personnel requested
to participate in EPA activities described above.

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                               -9-
9.  AUTHORITY
    APPROVED AND ACCEPTED  FOR
    THE ENVIRONMENTAL  PROTECTION
    AGENCY

    BY
       77"
       'hn A.  Moore,  DVM
    TITLE:   Assistant  Administrator
             for Pesticides  and
             Toxic  Substances
                          APPROVED AND ACCEPTED FOK'
                          T.HE NATIONAL TOXICOLOGY
                          PROGRAM
                          BY:
                             David P.  Rail,  MD,  Ph.D
                          TITLE:   Director
    DATE:
-o
DATE:

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                     MEMORANDUM OF AGREEMENT
                             BETWEEN
                 THE COMPLIANCE MONITORING STAFF
                THE OFFICE OF TOXIC SUBSTANCES AND
                 THE OFFICE OF PESTICIDE PROGRAMS
         IN THE OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
                    FOR A MANAGEMENT FRAMEWORK
                        FOR THE CONDUCT OF
              LABORATORY INSPECTIONS AND DATA AUDITS
1.   PURPOSE AND PRINCIPLES
     A Laboratory Data Integrity Program (LDIP)  has  been estab-
lished within the Compliance Monitoring Staff (CMS)  of the Office
of  Pesticides and Toxic Substances (OPTS).   LDIP is  specifically
charged with developing and conducting laboratory inspection
and data audit programs to assure the reliability and validity
of  data reported to EPA under both the Federal  Insecticide,
Fungicide and Rodenticide Act (FIFRA) and the Toxic  Substances
Control Act (TSCA) Sections 4 and 5.  This  Agreement establishes
the matrix management framework under which CMS, the Office of
Pesticide Programs (OPP) and the Office of Toxic Substances
(OTS)  will work cooperati-sly to assure an  effective laboratory
inspect ion and data audit program.

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                               -2-
2.  PROGRAM ABSTRACT

     CMS will establish and chair the .Laboratory Data Integrity
Program Panel (the Panel) which will also include members  from
OPP and OTS.  The Panel will serve as the conduit for the  flow
of information between participating Offices and will periodically
review LOIP policies, procedures, and operations and advise  the
Director, CMS, who has full responsibility for implementing  the
program, of recommended program improvement and changes.   The  Panel
will  serve as a steering committee to ensure that Agency  commit-
ments and objectives of the LDIP are fully implemented and
met.
     The CMS will have the lead in directing the program  by  (1)
coordinating all FIFRA- and TSCA-related laboratory inspections
and study audit activities with OPP and OTS as well as by  (2)
liaison with other agencies, such as the Food and Drug Administra-
tion (FDA) and the National Toxicology Program (NTP), which
cooperate with the EPA in laboratory inspections and data  auditing.
LDIP will be the Agency contact for scheduling FDA and EPA labora-
tory inspections and study audit activities, as well as for  receiv-
ing and disseminating audit and inspection reports to both OPP and
OTS.   LDIP will monitor the status of each inspection and  audit.
     It is the goal of LDIP to (1) ensure full compliance with
FIFRA and TSCA Good Laboratory Practice (GLP) regulations, as
applicable, a: all testing facilities performing studies  to  be
presented to the EPA to meet requirements of both FIFRA and
TSCA and (2) to audit  fully all data supporting the  results  of

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                               -3-





these studies.   Both the CMS and the OPTS Program  Offices  are



responsible for recommending studies for audit  and  laboratories



for i nspecti on.



     The OPTS Program Offices will provide the  scientific  review



of laboratory GLP inspection reports and data audit   reports of



studies within  their respective program areas to LDIP.   Program



Office scientists will  participate in inspections  and  study



audits at laboratories, as  appropriate and as  resources  permit.



     A detailed description of the responsibilities  of CMS,  LDIP,



OPP, OTS and  the Panel  is given in Section 3 of this document.



     A detailed definition  of terms used in this document  is given



in Section 5  of this document.





3.  DIVISION  OF RESPONSIBILITIES





     a.  Compliance Monitoring Staff



          (1) Appoints  the  Chairperson of the  Panel.



          (2) Establishes inspection procedures and  specific audit



procedures, with necessary  technical input and  review from OPP



and OTS.



          (3) Establishes neutral administrative  inspection  schemes



for routine selection of laboratories for inspection and,  based



on recommendations from PPP and OTS, specific  criteria for "for



cause" and follow-up inspections, where necessary.



          (4) In conjunction with the Regional  Offices,  supports



appropriate enforcement actions based on the information provided



in reports, audits, reviews and impact assessments.   Notifies



OPP and OTS of  the progress and disposition of  compliance  procedings

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                               -4-

          (5) Responds to FOIA requests for Information  on  and
availability of completed -compliance inspection reports-(GLP
Inspections or data audits).
          (6) Reports program activities to the Assistant Admini-
nistrator for Pesticides and Toxic Substances and to the Admini-
strator through the Management Accountability System.
     b.  Laboratory Data Integrity Program
          (1) Closely coordinates activities with FDA and NTP  to
avoid duplicative efforts and to achieve maximum efficiency in
auditing studies used for government decision making.
         (2) Trains EPA  inspectors and auditors in the conduct  of
laboratory inspections and audits with technical assistance from
OPP, OTS, FDA, NTP and contractors as needed.
         (3) Establishes and maintains an accessible data  file  o
studies submitted to or  required by the EPA under TSCA Section  4
Test Rule or Negotiated  Testing Agreement, TSCA Section  5  Signifi-
cant New Use Rule, Section 5(e) Order, FIFRA Sections 3, 5, 8,  18
and 24(c) as well as FFDCA Sections 408 and 409.  This data file
will be maintained and updated by LDIP staff and will  permit  the
tracking of both CMS-directed activities on studies as well as
OPP- or OTS-negotiated study milestone dates starting with  the
date of agreement betwe'.-n OPP or OTS and Sponsor and ending with
the final study data audit report.
        (4) Receives copies of notices of deliverabies sent by test
                 /
Sponsors to EPA Product  Managers and enters dates of deliverables
into the data file.  The deliverables themselves are directed
to  OPP or OTS by the Sponsor.

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                               -5-
        (5)  Notifies OPP or OTS Product  Managers  of 'schedule devia-
tions and refers to CMS evaluations -by  OPP  or  OTS scientists of
deviations as well  as recommendations  for  action.
        (6)  Receives notices of sponsor-requested protocol  changes
and refers these requests to the  OPP  or  OTS Product Manager  for
evaluation and recommendations.  Refers  these  evaluations  and
recommendations to  CMS for communication to the  Sponsor.
        (7)  Maintains security as needed on all  reports,  schedules
and data files under its control.
        (8)  Within  the constraints  of  available  resources  selects
laboratories for inspection and studies  for audit based  on the
neutral  administrative schemes and  selection criteria  of  CMS along
with target  lists and selection criteria supplied by  OPP  and OTS.
        (9)  Schedules data audits and  laboratory  GLP  inspections
for health effects, for ecological  effects  and chemical  fate
studies.  Coordinates the audit and  inspection schedule  with
FDA, EPA Regional Offices and with  OPP  or  OTS scientific  support
staff as necessa'ry.
        (10) Receives inspection  and  audit  reports from  FDA and
EPA inspectors after the audit or inspection is  completed.
        (11) Develops and utilizes  procedures  for clarifying ques-
tions and resolving conflicts raised  in  data audit reports with
the testing  laboratory and/or the test  sponsor prior  to  issuing
a final  report of a data audit to ensure that  the audit  can  be
properly evaluated.
        (12) Prepares GLP compliance  reports and  final  data  integ-
rity statements based on inspection  reports as well  as  reviews

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                               -6-

of the raw data and final study report.
     c.   O'ffice of Toxic Substances and the Office of Pesticide
Programs
          (1) Appoint a representative to the Panel.   This  repre-

sentative will also be the focal point for all  information  exchange
between OPP, OTS and CMS and will serve as technical  program  repre-
sentative.
          (2) Provide LDIP with information needed to track  studies
submitted to or required by the EPA under TSCA  Section 4 Test
Rule or Negotiated Testing Agreement, TSCA Section 5  Signifi-
cant New Use Rule, Section 5(e) Order, FIFRA Sections 3, 5,  8,  18
and 24(c) as well as FFDCA Sections 408 and 409.
          (3) Maintain a current awareness of LDIP-set laboratory
GLP inspection and study audit schedules from the LDIP data  file.
Recommend to LDIP changes in these schedules when problems  are
noted that may jeopardize a study.  Such requests will contain
an assessment of the need for the inspection or audit based  on
OPP or OTS review, pending regulatory decisions and other estab-
lishedcriteria.
          (4) Provide LDIP with copies of the study protocols and
revisions , FIFRA or TSCA testing guidelines for each type  of
test, available EPA scientific reviews, and all study interim
and/or final reports as well as other pertinent test  information
from both the rponior and the testing laboratory before inspections
and audits are undertaken.

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                               -7-

          (5) Within resource constraints  designate  appropriate
scientific staff to accompany FDA and EPA  inspectors  on  GLP
inspections and study audits as requested  by LDIP.   Staff  scien-
tists may participate in routine inspections and  audits  as  recom-
mended by LDIP, and will participate in inspections  and  audits
where violations are suspected by CMS.
          (6) Provide LDIP in a timely  fashion  with  review  and
assessment of Sponsor-initiated protocol  changes,  test  laboratory
schedule changes and any other study-related information from
either the Sponsor or the testing laboratory.
          (7) Provide LDIP in a timely  fashion  with  regulatory
significance reviews of GLP inspection  and data or study audit
reports including an assessment of the  impact  of inspectional
or audit findings on the study itself.
          (8) Recommend, to CMS and LDIP,  specific criteria for
"for-cause" or "priority" GLP inspections  or study data  audits.
          (9) Regulatory decisions (registrations, cancellation,
suspension, rule-making, etc.) are the  responsibilities  of the
program offices; enforcement responses  (stop-sale, civil complaints,
etc.) are the responsibility of CMS.
     d.  The Laboratory Data Integrity  Panel:
          (1) Serves as a steering committee to ensure  that EPA
committments and objectives on LDIP are implemented and met.
          (2) Serves as a steering committee to oversee the manner
in which LDIP tract's studies under FIFRA and under TSCA Sections
4 and 5.
          (3) Assists CMS in evaluating the effectiveness of the

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                               -8-
audit and inspection programs through periodic  program  reviews.
          (4)  Advises the Assistant Administrator  for  Pesticides
and Toxic Substances through the Director, CMS, of  recommended
improvements and changes in LDIP.
          (5)  Reviews, at the request of LDIP, criteria  for  labora-
tory' inspection and study audit priorities to ensure  that  needed
changes in inspection or audit schedules are made  promptly and
in a manner consistent with OTS requirements.

4.  IMPLEMENTATION
     The Director, OTS and the Director, OPP shall  select  that
Office's representative for the Panel within 30 days  of concurrence
in this Memorandum of Agreement by the Assistant Administrator.
The Panel members' names shall be provided to the  Director, CMS.

5.  DEFINITIONS
     a.  Data Audit - The data audit is the process by  which  the
Agency determines the validity of the results of any  ongoing  or
completed laboratory study.  Validation is accomplished by
examining raw data and other records generated  during the study
with results provided in the study report.  A data  audit is not
a scientific review of the conclusions of the study.   Data audits
may be partial or full.
          (1) Partial data audits are associated with:
                  i
             (a)  In-life studies where data are still  being
generated and the audit provides confidence that the  data in
general are being generated according to protocol  requirements    '
and time frames and properly recorded.

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                               -9-
              (b)   Completed studies  where  selective  percentages
of available data  a re examined.
          (2)  Full  data audits are those  audits  where,  insofar  as
possible, all  raw  data from all  segments  of a  completed  study are
audited.   Full  data audits are usually associated  with  ruleor
regulation processes where full  prior validation of the
results is considered necessary.
     b.  Study  Audit - A study audit  compares  the  actual  conduct
of a study with the approved study protocol.   A  study audit  con-
tains elements  of  a data audit and a  Good Laboratory  Practices
inspection and  may be partial  or full.
     c.  Good  Laboratory Practices (GLP)  Inspection  - The authority
for GLP inspections is contained in 40 CFR  Part  792  (TSCA) and  40
CFR Part  160 (FIFRA).  A GLP inspection is  an  inspection of a  test
facility  or laboratory where EPA-related  test  data are generated.
The purpose of  such an inspection is  to ensure full  compliance  with
GLP's (as regulations).  GLP inspections  may be  carried out by  EPA
inspectors or by inspectors or other  designees of  other government
agencies  under  interagency agreements.  At  present such an inter-
agency agreement exists between EPA and FDA.
     Other definitions pertaining to  studies and to  GLP are con-
tained within the  GLP regulations.

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                               -10-
6.  CONCURRENCES


    /
        Moore, D.V.M.
Assistant Administrator
for Pesticides
and Toxic Substances
Date
                 ictxTr
Don R.  Clay, Direi
Office  of Toxic Substances
 Date
Edwin L. Johnson, Director
Office of Pesticide Programs

  Date
                                           go
A. E. Conroy/11 ,| Di rector
Compliance Mbnitbring Staff
Office of PestiVides and Toxic
 Substances
   Date

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United States         Pesticides and
Environmental Protection    Toxic Substances      Washington, DC
Agency            Enforcement Division    20460
Federal Insecticide, Fungicide,
and Rodenticide Act
Compliance/Enforcement
Guidance Manual
Policy Compendium
Volume 3:   FIFRA Compliance
Monitoring Strategies

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Table of Contents
The revised FIFRA Compliance Enforcement Guidance Manual Policy Compendium has been designed
as a  series  of volumes to accommodate expansion as new guidances are added.  Volume 3 of the
Compendium contains compliance monitoring strategies issued by the Office of Compliance Monitoring,
with  other pertinent guidances issued by other EPA offices. The Appendix in Volume 1 provides the
Table of Contents for each volume of the Compendium, a list of FIFRA miscellaneous sources, and a
list of obsolete documents.  A detailed, cross-referenced Index is provided to help locate specific material
throughout each volume of the Compendium.

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 3:  FIFRA Compliance Monitoring Strategies
                      TITLE                                                     DATE

Enforcement Facts and Strategy; Compliance Monitoring Procedures; Water                   10/80
Water Purification Devices

Strategy for the Enforcement of the Child Resistant Packaging Regulation                  06/08/81
Under FIFRA

General Compliance Strategy for Products Subject to the FIFRA Label Improvement         04/21/83
Program

Compliance/Enforcement Strategy for the Federal Insecticide, Fungicide, and               11/22/83
Rodenticide Act (FIFRA)

Strategy for the Enforcement of the Good Laboratory Practice Regulations Under TSCA     01/15/85
and FIFRA
FIFRA Compliance/Enforcement                                          Guidance Manual
Policy Compendium                          i                              November 1990

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Volume 3
                             Table of Contents
               Volume 3: FIFRA Compliance Monitoring Strategies (continued)
Compliance Strategy for FIFRA 3(c)(2)(B) Suspensions

Compliance Monitoring Strategy for Enforcement of Pesticide Registration
Cancellations Due to Non-Payment Fees

Alar (see Daminozide)
                                      DATE

                                     09/03/85

                                     08/21/90
Aldicarb

Aldicarb Compliance Monitoring Strategy
                                     04/30/90
Aldrin and Dieldrin

Continuing State Registration of Products Containing Aldrin and Dieldrin for Which
Uses Have Been Suspended
                                     01/10/75
Arsenicals

Compliance Strategy for the Cancellation of Non-Wood Uses of the Inorganic
Arsenicals
                                     06/06/89
Bromoxynil

Compliance Strategy for the Conditional Registration and Cancellation of Certain
Bromoxynil Products
                                     07/06/89
Carbon Tetrachloride

Compliance Strategy for the Cancellation of Carbon Tetrachloride
                                      07/13/87
FIFRA Compliance/Enforcement
Policy Compendium
11
                             Guidance Manual
                               November 1990

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Volume 3
                             Table of Contents
               Volume 3:  F1FRA Compliance Monitoring Strategies (continued)
                       TITLE
                                       DATE
Chlordane-Heptachlor

Enforcement of Administrator's Decision and Order Suspending Most Uses of
Heptachlor and Chlordane

Clarification of Heptachlor/Chlordane Suspension Order

Status Report on the Heptachlor/Chlordane Suspension

Heptachlor/Chlordane Suspension Order Enforcement Strategy

Heptachlor/Chlordane Suspension Order Enforcement Strategy-CORN USE

Continued Enforcement of the Suspension of Registration for Certain Products
Containing Chlordane and Heptachlor

Revised Compliance Strategy for the Cancellation and Suspension of Chlordane
and Heptachlor Termiticides


Chlordimeform

Chlordimeform Strategy

Final Compliance Strategy for the Cancellation of Chlordimeform


Compound 1080

Compliance Monitoring Strategy for Compound 1080 Livestock Protection Collars
                                      01/15/76


                                      01/22/76

                                      02/19/76

                                      03/23/76

                                      08/27/76

                                      11/23/76


                                      04/13/88
                                      02/09/89

                                      06/19/89
                                      07/25/86
FIFRA Compliance/Enforcement
Policy Compendium
in
                              Guidance Manual
                                November 1990

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Volume 3
                            Table of Contents
               Volume 3:  FIFRA Compliance Monitoring Strategies (continued)


                       TITLE                                                    DATE

Daminozide (Alar)

Final Compliance Monitoring Strategy for Daminozide (Alar)                            10/20/86

Compliance Strategy for the Agreement to Voluntarily Halt Sales of Food-Use              06/14/89
Pesticides Containing Daminozide


DBCP

DBCP Suspension Order Enforcement Strategy                                         11/07/79


Dinoseb

Compliance Strategy for the Emergency Suspension of Dinoseb                          10/07/86

Amendment to the Compliance Strategy for the Emergency Suspension of Dinoseb          04/02/87

OCM Memorandum:  Dinoseb                                                      04/17/87

OCM Memorandum:  FIFRA Section 18 for Dinoseb                                   03/14/88

OCM Memorandum:  Dinoseb Stipulated Order                                        03/28/88

Compliance Monitoring Strategy for Final Cancellation of Dinoseb                        06/15/88

Compliance Monitoring Strategy of the June 9, 1988 Dionseb Cancellation Order            03/03/89
for the 1989 Growing Season
Compliance Strategy for the Cancellation and Registration Amendments for Pesticide
Products Containing Ethylene Bisdithiocarbamate (EBDC)
                                     03/12/90
FIFRA Compliance/Enforcement
Policy Compendium
IV
                             Guidance Manual
                               November 1990

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Volume 3
Table of Contents
               Volume 3:  FIFRA Compliance Monitoring Strategies (continued)
EPS

Memorandum:  "Indemnification Claims for Suspended EDB Products"

EDB Facts - EPA Decision

Memorandum:  "Emergency Suspension of Products Registered for Use as a Grain
Fumigant or Spot Fumigant of Grain Milling Machinery"

Strategy for Compliance/Enforcement of the Emergency Suspension of Ethylene
Dibromide (EDB)
         DATE



         10/06/83

         02/03/84

      02/06/84(a)


      02/06/84(b)
Lindane

Compliance Monitoring Strategy for Cancelled Lindane Products

Memorandum from A.E.  Conroy to Region VII:  "Lindane Notice of Intent to Cancel
vs. Registration Standard"
         04/25/85

         07/10/86
Mercury

Conclusion of Mercury Cancellation Proceeding

Enforcement of Mercury Settlement
         10/28/76

         01/06/77
2.4.5-T and Silvex

Enforcement of Administrator's Emergency Orders Suspending 2,4,5-T and Silvex
Registrations

Further Guidance Concerning Enforcement of the Administator's Emergency Orders
Suspending 2,4,5-T and Silvex Registrations

Further Guidance on the Cancellation and Suspension of 2,4,5-T and Silvex
         03/07/79
         04/05/79
         08/20/79
FIFRA Compliance/Enforcement
Policy Compendium
Guidance Manual
  November 1990

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Volume 3	Table of Contents

               Volume 3: F1FRA Compliance Monitoring Strategies (continued)


                      TITLE                                                    DATE

Toxaphene

Toxaphene Cancellation Compliance Strategy                                         01/01/83


Wood Preservatives

Compliance Monitoring Strategy for the Wood Preservative Uses of Creosote,             10/23/86
Pentachlorophenol, Inorganic Arsenicals


                                                                                   Page

Index	  1-1
FIFRA Compliance/Enforcement                                         Guidance Manual
Policy Compendium                         vi                            November 1990

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     ENFORCEMENT FACTS
       AND STRATEGY
   **************** *****
        COMPLIANCE
   MONITORING PROCEDURES
WATER PURIFICATION DEVICES


       October 1930
              Pesticides & Toxic  Substances
                   Enforcement  Division
                   Office of Enforcement
           U.  3.  Environmental  Protection Agency
                  Washington, D.  C.   20460

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STRATEGY OVERVIEW	1

BACKGROUND	2

?.i:-VLATSD INDUSTRY	3

APPLICATION OF FIFRA	4
   Requirements of FIFRA
   FIFRA Enforcement Authorities

REMEDIES- -----------------------6
   General
   Misbrand ing Purifier Claims
   Ineffective Water Purifiers
   Recall
   Other Violations of FIFRA
   Criminal Citations

COMPLIANCE MONITORING - 	  9
   Program Development Overview
   Guidelines for Selection of Devices To Be Tested
   Inspection
   Post Inspection
   Testing
   Pesticide Enforcement Management System (PSMS)
   Outreach

CASE DEVELOPMENT	14

ALLOCATION OF RESPONSIBILITIES	,-15

ENFORCEMENT FACTS AND STRATEGY-	--19

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 trategy Over view _ __ _

     Water purifiers are products which are intended to render
       er sa'fe to drink by removing pests (microorganisms ) through
       chemical or physical means.   Water purification devices
el.ate peats (microorganisms)  from water by using a physical
method such as ultraviolet light, filtration, or other non-chemical
means.  To qualify as a "purifier", the product must remove all"
disease causing microorganisms from the water, including bacteria,
viruses, and cysts.  Since devices are not subject to the regis-
tration requirements under FIFRA, regulation of them falls entirely
on the Office of Enforcement,  which must determine if they comply
with the other requirements of the Federal Insecticide, Fungicide,
and Rodenticide Act to which they are subject.  The key to the
compliance determination will be  verification of label claims
through a program of product testing.

___________ T_he .jtejstinjg program_will examine the purifier claim used by
many products.  If a product cTalms "'"to 'be""a pur i"fTer b"ut""it 'does   "
not remove test organisms in the  efficacy test, the product is
deemed to be misbranded and subject to enforcement action under
FIFRA, including Stop Sale Orders to remove the product from the
marketplace.  The testing scheme  designed for this program consists
of two phases.  Phase I tests the ability of the products to .
remove environmental coliforms.   Phase II tests specific bacterial,
viral and protozoan pathogens likely to be found in water such
as Pseudomonas aerogenosa, Poliovirus and Giardia lamblia.  To
substantiate a purifier claim, a  product must pass both phases.
      if it fails Phase I, enforcement actions will be taken,
        spending time and money on the Phase II tests.
     The goal of the program is to remove from the market those
pro-ducts which do not purify water to protect the health of persons
who might rely on the products for safe drinking water.

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 Background
      Water purifiers are a class-of products  which  are  intended
 to  render  unprocessed water safe for drinking.   They  nay be used
 in  horses which obtain water from wells,  by  backpackers  to treat la
 and stream water,  by persons whose  community  water  supply nay  be
 temporarily contaminated,  and by vacationers  who may  encounter water
 of  questionable quality.  Consequently,  failure  of  a  product to
 adequately purify  water may present a serious public  health hazard.

      Because purification  of water  involves the  killing of micro-
 organisms,  which are defined as pests in Section 2  of PIFRA, these
 products are regulated by  the Environmental Protection  Agency.
 There are  two kinds of water purifiers:   Those which  employ a  chemical
 means to purify water, and those which use  a  physical method.  While
 both types are subject to  the provisions of FIFRA,  including but  not
 limited'to, Sections 7, 8, and 12 as well as  Section  2(p) and  (q),
 only purifiers utilizing a chemical must obtain  product registration
~a""p~r"e"scrIb"el""b"y""Sec"!t'io"a "3 ~o"f the" Act.	Under- Section- 25-("C-K4-)o--		
 FIFP.A the  Administrator is authorized to declare a  device subject  to
 the Act.   Water Purification devices are among those  devices subject
 to  the Act (see Fed. Reg.  Vol. 41,  No.  225, page 5*065, November  19,
 1976).

      The  registration process for chemical  purifiers  is central  to
 the Agency's ability to evaluate the risks  and benefits presented
 by  the product.  If data submitted  to the Agency does not support
 the label  claims made for  the chemical purifier, the  Agency will
 not register the product.   Enforcement of the labeling-an-d misbrand-
 ing provisions of  ?I?RA is very straightforward  for chemical-based
 water purifiers.  If a manufacturer makes claims on a label that  do
 not appear on the  label accepted by the Agency at the time of  regis-
 tration, then the  manufacturer has  violated PIPRA by  "making  claims
 in  excess  of those accepted at the  time of  registration," which  is
 a misbranding violation.

      "vater purifiers which use a physical means  of  microorganism
 elimination are devices, and are therefore  subject  to the same
 requirements of FIFRA as the chemical water purifiers except that
 they are exempt from product registration requirements.  Conse-
 quently, since a premarket label review based on test data
 was not performed, products may appear on the market  with
 label claims which falsely exaggerate the capabilities  of the
 product.   If the claims.,-are found to be "false or misleading," the
 product is misbranded as defined in PIFRA Section 2(q)  and subject
 to  enforcement action.

      The EPA cannot require the manufacturer  to  substantiate  the
 claims made for the product, so to  evaluate the  performance of such
 devices, EPA must  sample and test the devices.   The results of labo-
 ratory analysis will document or call into  question claims made
 on  the labeling.  The test results  will also  form the basis for
 enforcement actions brought against a manufacturer  making false  or
 sis", e ad ing claims.

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      Water  purification device producers are generally small
 "businesses,  although  a few large companies are also in the market.
 There are approximately 50 purification devices now on the market.
 Producers must  register their establishments, but there.may be some
 producers who  have  not done this.

      Almost any available physical method that might kill a micro-
 organism is  employed  in at least one product.  The most popular are
 ultraviolet (UV)  light, micropore filtration, chlorine generators,
 and  ozone generators.   Ultrasound, reverse osmosis, electrolysis,
 and  distillation are  other known methods used by purification
 devices  (See Appendix I).  These types of devices are called "point-
 of-use" treatment products, since the water is treated immediately
 before use.   "Small systems" treatment products treat water intended
-for., u-s-e  i-r..-3.mal.l. c^amu.niia3_..-_-g5Ji5.C3.1,ly_..^e.y^,Jial, .tajps_jmd_a_Jlistj_i-
 cution network  are  part of the system.  "Small systems" treatment"
 units are 'also  regulated under FIFRA but the quality of the water
 produced is regulated by the Safe Drinking Water Act.  Since the
 public is protected under another Act and the resources of the Office
 of Enforcement  are  limited, these products will not be tested as  part.
 of  this  program.   However, if such products are found to be ineffective,
 they may be subject to enforcement actions under FIFRA.
                                -3-

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 Abdication of FI7RA
      ?I?HA and its implementing regulations clearly apply to devices
 The  requirements of those regulations are outlined below.  State
 laws  are often ambiguous where devices are concerned.

      Since it is desirable that Stop Sale Use or Removal Orders
 have  nation-wide applicability, this policy is to be administered
 as a  federal program.  State inspectors who may collect evidence
 will  turn that evidence over to the appropriate Regional office
 for enforcement actions.

 Requirements of FIFRA

      Producers of water purification devices are regulated under
--"??. A-r'-th-e- a-i>pli-c-abl-e- -se-ct i-ons--inc-lu4e- but- are.-not	l-im-it
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FIFRA Enforcement Authorities

     Failure to adhere to any of the above requirements jof FIFRA may
be an unlawful act under 12 of FIFRA as follows:

     "Failure to register the establishment [Section 12(a)(2)(K)]
     "Failure to keep books and records or to perrait inspection of
        books and records [Section 12 (a)(2)(B)]
     "Misbrar.ding [Section 12 (a)d)(F)]
     "Failure to file production reports [Section 12 (a)(O(N)]
                               -o-

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.-.e~ei i es	

C-er.eral

     FIFRA provides several remedies for violations of-.its provi-
sions.  If the purifier efficacy claims are found to lie false,  a
serious public health hazard can exist, and a Stop Sale, Use,  or
Removal Order will be issued immediately to limit the availability
of the product.  Penalties for other violations are to be determined
through*application of the general FIFRA penalty policy and matrix
(39 Federal Register 2771, July 31, 1974).   Civil penalties for
-isbranding violations, which are applied in addition to Stop Sale
friers, are to be determined by consulting the penalty matrix for
Ineffective Water Purifiers, below.  If there are severely misleading
claims, particularly in advertising material, the case may be
referred to the Federal Trade Commission through headquarters.

"isbranding Purifier Claims

     Water Purification Devices which fail the purifier efficacy test
are misbranded.  A Stop Sale, Use or Removal Order will be issued to th
manufacturer of any product which fails the efficacy test.  The.Stop
Sale is issued because of the health hazard 'presented by the continued
sale or use of the product, and will not be lifted until the product
coses into compliance with the Act.

     In addition to the Stop Sale Order, a civil penalty will be
assessed as described below".  The Civil Penalty,must be assessed
within fourteen days of the Stop Sale Order.  _'

(This is consistent with the penalties for similar violations in the
current FIFRA Penalty Matrix.)

Ineffective Water Purifiers


                           I      II      III      IV      V

1.  Category A           5000    5000    5000     5000    5000

2.  Category B           1000    1750    2500     3200    4500
     \   See A. 3. Cor.roy's Memorandum of September 12, 1930, "Interim
Final Regulation Section 13, FIFRA."
                               -6-

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Category A - Products in this category failed Phase I of the  testing
    "**protocol (see Strategy Overview page 1).  Phase  I tests
             the ability of the product to remove a known group of
             pathogens which commonly occur in water, so products
             which fail are presenting the consumer with a potentially
             severe health hazard.

Category B - Products in this category passed Phase I "but failed
             Phase II.  Since viruses and cysts are pathogens as
             well as bacteria, a health hazard is also presented
             by these products, although the hazard is somewhat
             reduced by the removal of the coliform bacteria.

                  Some products in this category nearly passed
             the efficacy test.  It may be that a slight change to
   __         either the label instructions or the product itself
          ..... -.^-^ -v^i^g the pf 6Iuct""into-"coffi?rtaTTcre-"wi^h--^h-e"-A-ct-."'2-/---
             A Stop Sale Order would be issued in such cases, but it
             may be lifted when the manufacturer agrees that  he will
             immediately incorporate those changes which appear to
             have a reasonable likelihood of remedying the problem.
             The "modified'1 device is, of course, subject to  testing.

Recall

     Another remedy that is used either as an alternative to  a  civil
proceeding or in addition to one is a recall action.  Recalls may
be voluntary or compulsory.  If this remedy is employed, the  guidance
in Section 12 of the Case proceeding Manual should be followed.
    2/  For example, UV light kills viruses and bacteria but may
permit G. Iambiia cysts to persist in water.  Since the cysts are
relatively large, a pre-filter on the system could predictably
remove them.  Another example would be a chlorine generator whose
directions do not explicitly indicate the concentration and contact
time that are necessary for chlorine to effectively disinfect water
                               -7-

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Other Violations of FI??.A

    As described  in the section on the Application of FI7RA,
the Agency has authority to take enforcement action when
provisions of FIFr.A are violated.  Violations which do not
Involve the purification claim  (e.g. violation of Sect.ipns 2(p)
and (q), 7 and 8)  are also to be handled in the regions-according
to current enforcement policy.

     If enforcement actions based on violations of FIFRA which
do not include the efficacy of  the product are taken before the
efficacy tests are complete, the complaint or warning should
clearly state that additional action nay be taken if the results
of the efficacy test should prove to be unsatisfactory.  We recom-
mend that all civil actions be.initiated at the same time.
     Willful violations  of FIFRA may justify the filing of
criminal charges against  a manufacturer.  PTSED concurrence
would be required for criminal actions.
                               -3-

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   Gfven below are procedures for the compliance monitoring aspects of the
ogram with description of responsibilities ar.i data flow


   T-ulielir.es for Selection of Devices To Be Tested

   8   CM3-PT3ZD will select the devices to be tested and determine the
      order cf testing based on criteria noted below.

   0   Only "point-of-use'1 devices will be tested.  These devices consist
      of those intended for use in a single family household,  camper,
      boat, etc.

   0   Tvo categories will be established to help determine the order
 -	 of-tes-tir.2,.    .    .      .    .           ."   .
      -  The first category,  which will be given the highest
         priority, will contain those products for -which
         there is reason to believe that a violation
         has occured.  This will be determined by consumer
         or competitor ccnplaints, scientific judgement based
         on the study cf product design, and failure of the
         device in similar tests.

      -  The second category will contain all other products.
         The order of testing for this category will be determined
         by such neutral criteria as the number produced and dis-
         tributed, and the availability of testing space.  If
         production data is not available for all -devices,  the
         order of testing will be determined by random selection.

   e   CM3-PTS3) will prepare the sample request forms and forward
      them to the appropriate Region for collection.
   Inspection
      At the opening conference:

      -  The inspector should request efficacy data from the
         manufacturer pertaining to his/her device(s).   The
         manufacturer cannot however, be required to submit
         this data.

      -  The inspector should advise the mainfacturer that
         his/her product Is not being singled out for attention.
         The collection cf his/her device is part of a nationwide
         effort to test water our if i cat ion devices.
                                     -9-

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        Inspection cf boots ard  records  will be  performed in accordance
        with the Pesticides Inspection Manual for the purpose of deter-
        mining compliance with the record keeping requirements (3).
An o
            fficial sample  of the device will be collected at the producer
        establishment according to the Pesticides Inspection Manual.  The
        official samole will include labeling (including instructions 'for
        installation) and all other documentation as  required (Notice of
        Inspection,  Receipt for Samples, etc.).

        -   "Optional Equipment", such as a pre-filter, which
           is  required for  the qualify of water the laboratory
           will be  using should also be collected.  Specific
           guidance will be provided on the sample request
           fora.

        -   Because  many of these devices are very expensive, the .
       ....... jj33pector.-shmLd_c2ke.,an.^                              ....... ______
           donate the device,  ''any manufacturers have already
           indicated a desire to have their devices tested, and
           a willingness to donate them for this purpose.

        -   If  the manufacturer refuses to donate the
           device,  the inspector should offer to purchase it.

        -   Two samples of the device will be collected unless
           the cost of the  device exceeds S700.

        If the manufacturer requests to install the device himself,
        arrangements with the testing laboratory should be made
       If entry is denied:

       -   The inspector should follow established procedures
           for denied entry. /

       -   If a distributor of the product  can be located
           through reviewing -the ad vertising or contacting a
           local trade association, then a marketplace sample
           can be obtained.
    /  Barlow's  Decision:   Guidance to Re.ti.onal  Personnel:  Conduct
:f  Inspections  after the Barlow's Decision Upril  11,  1979)
                                       -10-

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   -  If a product sample obtained from the marketplace
      fails the efficacy tests, a warrant to conduct an
      in-depth bocks ani records inspection nay be
      obtained.  This will be necessary if production
      and distribution data is needed.
   When the requested.sample has been collected,  the "PRD
   Acknowledgment" copy of the sample request form will be
   forwarded to CX3-PTSED with the "Sample Identification"
   section completed.

   All non-confidential information obtained by the inspector
   will ba placed in the enforcement jacket and forxarded
   to the testing laboratory along with the device(s).

   -  A second copy of the device's labeling is to be assembled
      by the inspector and forwarded to CM3-PTSED for contract
      management purposes.
Testing

"  Efficacy testing will be performed by the State of New York,
   Department of Health, Division of Laboratories and Research.

0  Each device will be examined when received by the laboratory
   for arr,r possible defects resulting from shipment.

0  Chain of custody procedures will be followed for all official
   samples.

0  The device will be subjected to a series of rnicrobial challenges
   until it fails or exhausts the series.

   -  All failures will be confirmed by a second test

0  A second device will be tested if the first one fails.

   -  Enforcement action will not be initiated unless both
      samples fail

0  The testing laboratory '.-,111 be subjected to a Quality Assurance
   (QA) Performance Audit and a QA Systems Audit.  These audits
   will be initiated by ?TS3.

*  The testing laboratory will submit to CME-PTSH) a QA Program
   and Project Plan.
                                  -11-

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        CM3-PTSID  is  to  be  kept  informed of  the  testing status of the device.
        This information is to include:

        -  date  the official sample was  received

        -  date  testing  was initiated and ccapleted

      *  When testing  is  completed,  the laboratory will review the test
        results  and determine if the device  has  failed efficacy testing.
        All test results -will be placed  in the device's enforcement jacket.

        -  All enforcement  jackets  win  go directly to the appropriate
           Region  frm the  testing  laboratory for review to determine
           violations, and  to initiate enforcement action.

        -  A copy  of  the test results will be forwarded to CM3-PT5JD
           from  the testing laboratory to monitor the contract.

      *  The testing laboratory will retain all devices for which
        violations exist until enforcement action is completed
        or the case is placed in permanent abeyance.
V.   Pesticide Znfcrcement  "anagement System (?5M

     The Regions will keep  PIS2D  informed  as to  the enforcement status of
the device by entering  relevant information,  such as the date they issued
a particular order  or penalty, the results of the enforcement action, etc.
  to the PS-S Co-puter  system.


71.  Oat reach

     vany manufacturers of  water  purification devices do not appear to be
avare cf Section 7  establishment  registration requirements.  To help notify
ir^ustry of these requirements, a letter to potential manufacturers and
their trade associations has been prepared (Appendix III^&

     The responses  free this letter will allow the Agency to compile an
accurate list of manufacturers, their products,  and production and distri-
bution data.

     A press release has also been prepared announcing the program to the
public and notifying industry of  the establishment registration requirements
(Appendix
     As a result of  this  cut reach  program,  it  is  anticipated that the
public and the industry will  report  the  existence of various companies
which they suspect are not  in compliance with  the Act (establishments not
registered, products are  ineffective,  etc.).   All information obtained by
the Regions should be forwarded  to CMB-PTSID,  Comp" iance Monitoring
Coordinator.
                                       -12-

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     Microbiological data generated by this  prograa will  be  submitted tc.  the
Journal of Applied and Environmental Microbiology  for publication after the
enforcement cases are completed.  The results  of the tests may also  be
Presented at the 1932 Annual Meetings of the American Society for Microbiology.
                                                possible  that  presentations
n	**. ^^^.*,.j		,_,
will be nade to these groups.
     Regions nay release  information  concerning individual  cases  in the sane
manner that such information is handled  in  other civil proceedings.

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           PTSED

o reviews test results and
  labeling
o maintains a file of test
  results, labeling, and action
  taken
                                                         PTSED

                                            o requests samples
                                            o monitors program
                sample
                request
              notification of
              action taken
           Region
o-reviews lab's report, labeling
  and any records collected to"
  determine possible violations
o determines er.forcer.ent response
  and initiates action
o maintains official enforcement
  file en devices
             Region
o sets up enforcement jacket
o collects samples, performs
  inspections
o sends PRD Acknowledgment to
  CMB-PTSED
o sends copy of labeling to
  CMB-PTSED                ;
                sample &
                enforcement jacket
                     tsst results &
            Testing
            Laboracory

      performs  efficacy  tests
                  enforcement jacket
      on  devices
    o  reviews  test  results
     Determine product
         failure
                                                                      to.
           test results
                              -13-a-

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j.aoel review win oe aone Dy tne KegisTration Division using
the product performance criteria developed for evaluating "both
chemical and physical water purifiers and the data on produtt
performance fron the efficacy test.

     Please note that a civil complaint should be issued along with
the Stop Sale, Use or Removal Order when the product fails the
efficacy tests.

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Tnis cr.art is a guide to the resporiaibilities  for  the  different tasks  in the water
purification device enforcement program.	
           Headquarters (PTSZD)
                 Regions
1.    Identification of Purifier Devices

     *   Information sources:   ZRSS,
        consular queries,  competitor
        complaints,  advertising, other.
1.    Identification of Purifier Devices

     *  Regions submit info mat ion on
        netf products they bee one aware
        of to Compliance Monitoring
        Branch
2.   Selection of Devices to be Tested

     0  Compliance Monitoring Branch
        updates' list of known devices
        and selects devices.

     *  Policy & Strategy Branch will
        evaluate ITeatral Inspection
        Scheme.  All known devices
        will be tested.
     Allocation of Inspections

     0   Compliance Monitoring Branch deter-
        mines nazies and locations of device
        producer establishments;  assigns
        inspections to appropriate Regions;
        prepares sample request forms and
        sends then to Regions.
                                                 4.    Inspections  and  Sample Collection

                                                      0  Regions assign inspectors  to
                                                        conduct establishesnt  and/or
                                                        bocks  and records  inspections
                                                        and product sample and docu-
                                                        mentary material  collection.
                                                         (Inspections  may be made by
                                                        Federal or State  inspectors.)

                                                      0  Inspector performs inspection
                                                        according to  FETRA procedures
                                                        and guiciance;  special  instruc-
                                                        tions  may appear  on the sample
                                                        request fora.
                                      -15-

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       Headquarters (?T~ID)
                                                             Region
                                                     Inspector ships  sample(s) and
                                                     one set of documentary ma
                                                     to testing laboratory, ser
                                                     copy of documentary  sample
                                                     headquarters^
 Testing of Devices

 "   Laboratory (Environmental Health
    Center, State of New York, Depart-
    oent of Health, Albany, N.Y.)*
    performs efficacy test according
    to ITS 3) approved protocol;  furnishes
    results etc.  to PISH) and the
	Segisn-.- -(See -*I,3. below-.) The ...lab 	
    will keep the device until litigation
    is corn-Dieted.
Determination of Violations

0  The testing laboratory  indicates
   whether the product passed or
   failed the efficacy test.
                                                  Determination of Violations

                                                  0  Region review's  inspection data
                                                     and its set of documentary
                                                     material to determine existence
                                                     of violations under PIFRA
                                                     Sections 7, 8,  or 1 2 as we
                                                     as well as Section 2(q)
                                                     branding violations.

                                                  0  The regions are strongly
                                                     advised, particularly early  
                                                     in the program to send the
                                                     jacket to headquarters for a
                                                     pesticide Enforcensnt Review.
                                                     The reviewers compare testing
                                                     results against label and
                                                     advertising claims to deter-
                                                     mine if purifier claims are
                                                     false and .misleading (misbrand-
                                                     ing violation).  N.B.   The
                                                     enforcement jacket accompanies
                                                     the sample to the laboratory.
                                                     The laboratory inserts the data
                                                     from the testing program and
                                                     forwards the jacket to Regions
                                                     which may forward them to head-
                                                     quarters for Enforcement Review;
                                                     the jacket and the review will
                                                     then be sent back to the appro-
                                                     priate Region.
                                  -16-

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                                                                  Regions
                                                         Based  on the  laboratory's
                                                         determination,  the Regions
                                                         may initiate  action  on the
                                                         purifier plain.  This should
                                                         not preclude  discussion  of
                                                         the case with headquarters.
 7.   Determination of Appropriate
     Enforcement: Response

     *   If aisbrarding violation'based  on
        the purifier clain has occurred,
        headquarters niay provide additional
        info mat ion "based on historical files.
	A>p-rcpri-ate- records and- reconnendatians..__
        will be forwarded to the Regions.   If
        advertising is seriously misleading,  a
        referral to the Federal Trade Commission
        will also be made.
 7.    Determination of Appropriate
      Enforcement Response

      "   A Stop Sale,  Use or Removal
         Order (SSURO) will be issued
         for all products which fail
         efficacy test.  A civil penalty
		is. ..also_as3e_ssed_.	
         Region applies general FI?RA
         civil penalty policy and
         matrix to determine appropria.-'
         level of actions for ail .
         violations.
 8.    Znforce_ent Actions,  Litigation,
      Set-clerent

      0   PTS2D  :=ay,  under exceptional
         circumstances, initiate
         enforcement, actions.

      8   Sections of the agreer^nts
         which  involve label or product
         inprover.ents to bring the product
         into compliance are to be sent to
         PTS-D  for concurrence.
      Enforcement Actions.  Litigation,
      Settlement

      8   Regions will initiate
         enforcensnt actions
         (warning letters,  civil
         ccnplaints, SSURO's).

      8   Region may obtain expert
         testincny fro~ headquarters
         reviewers or laboratory
         scientists.
 9.    Ccm-pleted Case Files

      8   PTS3D  will maintain a file
         of all test data results and
         copies of Final Orders for use
         in dccu.r..enting the possible need
         for regulatory or legislative
         changes.
      Completed Case Files

      8   The Region should retain
         completed case files, in-
         cluding all relevant
         documents.

      8   A copy of the Final Order
         should be sent to PTSED.
                                       -17-

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           Eea-itruarters  (FTSZD)
                 Regions
10.  Publicity
10.  Publicity
      1  Start of Program
        - Press Release
        - Letters  to manufacturers  and
             trade associations.

        Release of data generated by
        testing program.   (Laboratory and
        Compliance Monitoring Branch;
        - Publication  of Scientific data
             in appropriate journals
        - Presentation in  proper forums.

      1  Consumer Information determined  as
      . ..._a..result. .of_.thfi_whole_..prQgrgm.	
        - nuriber distributed
        - type of use/risk factor
        - conclusion to be drawn from the
          program.
        Release of information abc
        individual cases in the ss
        manner as" other pesticide civil
        cases.
                                       -18-

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grLforcezent Facts and Strategy
       ^
  pendix I:   Types of Porifier Products                       20
 ^pendix II:  Legal Definitions,  "Purifier" ani "Device"      22
Appendix III: Publicity and Outreach                           33
                                      -19-

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                                                                   Appendix I
     Wa^er purification  devices  employ a variety of techniques to purify water.
The most common techniques are:

     8  Ultraviolet light - Light  of wavelengths around 260nm damages the DI1A
        of exposed, organisms,  "if  the exposure time is sufficient, the organisms
        are no longer viable.  Light may also be absorbed by the bonds of certain
        complex organic  molecules  -which could result in photolysis of those mole-
        cules.  Efficacy of this method depends heavily on the engineering of the
        whole system.  The protocols used by the Canadians are the basis of the
        screening phase  of the US  EPA Water Purification Device Testing Protocol.
        Duplicative verification of results on the same types of products used
        to develop the protocol  is useful to the U.S. and Canadian Enforcement
        Programs.

     8  Submicron Filtration - Some products filter water through "sieves" whose
        pores are about  0.4 micron.  Since a typical bacterium is 1 micron in
        diameter, these  products frequently make purifier claims.  Unfortunately,
        a very large virus would be only 0.1 micron in diameter and some bacteria
        are capable of changing  shape.  The filter would consequently not work.

     0  Ultrasound - High frequency sound causes pulse waves to form in water.  The
        rapid changes  in water pressure result in "shearing forces" which- cause
        bacterial cell walls to  break.  This technique is used in a research setting
        to avoid chemical denaturing of mac r molecules and cellular orgar.elles.
        'whether it would be efficent on the scale necessary to purify water is un-
        known.

     0  Chlorine generators -  These devices electrolyse salt (NaCl) to form chlorine.
        The chlorine ac'3 as a disinfectant to purify water.  Tnese products are devices
        and not chemical pesticides because the product which enters channels of trade
        is not a chemical.  The  consumer generates the pesticide at the site of use
        for his own use  and not  for sale or distribution.  Unfortunately, since there
        has been virtually no  regulation of these products, the label directions may
        not be sufficiently explicit to ensure efficacy of the product.  Chlorine
        levels can be tested using a simple test kit and the presence of adequate
        levels of free chlorine  for a minimum contact time would ensure a reasonably
        pure water.

     0  Ozone generators - Oxygen  from air is electrically ionized to form ozone, a
        powerful oxidizing a^nt and disinfectant.  Unlike chlorine, ozone- 'does not
        persist (it rapidly decomposes to oxygen) and cannot be easily measured.  It
        is difficult for consumers to know if the device is actually working or if
        some minor product failure has resulted in lower levels of ozone production.
        Installation is  complex  -  often done by the seller - and cheaper products
        may be unsafe  electrically.

     "  Electric current -  Presumably the microorganisms are electrocuted by the
        passa^ of an electric current through a water reservoir.

     0  Distillers -  These products condense stesm from boiled water.

                                      -20-

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        Microorganisms are killed by boiling.   Distillation can concentrate
        certain organic compounds.

     *  Reverse Osr.osis -  High quality organic polymer membranes
        selectively filter water. This product is similar in principle
        to a kidney dialysis machine. It is a pctentialy workable means
        of purifying water since the pores of the membrane act as a
        molecular sieve.  Complex organic molecules are prevented from
        crossing over to the "pure water" side of the membrane. Viruses,
        bacteria and protozoans would also be retained on the "impure
        side".  Maintenance of these products is important.  A damaged
        ce-brane would not purify water.  There is sose indication that
        old membranes may themselves be colonzied by some forms of bacteria
        which use the organic polymer as a food source.

     Two types of products which are labeled as water purifers will not be
tested:

     e  Potable water "rurifers" - These products use the term purifier on
        their labeling "out are clearly intended for use on water that
        is already potable (i.e., faucet "purifiers" for use on municipally
        treated water). *'.?.mfacturers of these products should be warned
        that use of the term "purifier" is for products which process
        untreated water.  (See 41 Federal Register 32778, August 5, 1976)
        Other enforcement actions may also be necessary.

     0  larse rurifiers which treat water for groups of tventv-five persons
        or more.  These products are regulated by PIJHA.   However,  the quality
        of the water is requlated by the Safe Drinking Water Act.   Since
        the public is protected by another act and the resources of the Office
        of Enforcement are limited, these products will not be included in this
        program.  (These are also known as "snail systems" purifiers.)
                                      -21-

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                                                             Appendix II
                    Legal Definitions,  "Purifier"  and  "Device


      Since the enforcement strategy and penalty policy  rests on  the
definitions of "water purifer" and "devices," the following material
is  attached to support the definitions used in this document:

A.   Purifier:
       1.   FTC  ruling in the matter of Sibco Products  Company Inc., Et Al.
           (63  FTC (1965) pg. 917).

"  " *  2'." ' Guideli nes' for Registering - Pesticide-Products -in -the United 'States  - 
           Section G:  Product Performance Standards for Water Purification
           Devices.

       3.   ZPA  ruling In re Contact Industries,  Inc.,  I.F.  & R. Docket No. II-?S6
           (1973)  pg. r.

3.     Devices

       Pest Ccntol Devices and Device Producers: Consolidation and Clarification
       of Requirements. Federal Register, vol. 41, no. 225  (11/19/1976).
                                        -22-

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                                              st
                          IN THE MATTER or 

           -SIBCO PRODUCTS COMPANY, IXC., ET. AL.

   ORDEBr OPLVIOX, ETC., IN BECABD TO THE ALLEGED VIOLATION OP TH2
                    %FEDEEAL TRADE COMMISSION ACT         '

  ?". ^ .* ?**" 552S- Complaint. June 8, ISe-t^-Decuion^oo. 22.1965-
  'Orde? requiring a"N*w Jersey  manufacturer" of' water Yiltaton to ceaw
                ja=  thj effectives ar.d capability of its water filtration
               decepbvely guaranteeing the perfonnanca of aoch unita. .
              ' 8X6IBCO TEO3UCTS-CO.,aNC.,7rr.-AL:Vf         -317

      i                       {Opinion
 - .2. Imptie'd ..Represer.tsiiorw -Respecting -~MicTo-*organis7ns-"and""
 Viruses
 ' Complaint counsel charges that by the use of such words as"ptire,^
 "purify" and "clean" and the phrase "pure drinking and cooking
 water are vital to the health of your family * ~ " in connection with
 the unit, respondents are implicitly representing that disease-carry-
 ing water will be mace safe for drinking through the use of the Sibco
 "Purifier."                                                  
   Respondents 'admit that the unit  will not  kill  micro-organisms
 but maintain that the words  quoted above -do -not -constitute -an
 implicit  representation to  this effect., .Moreover,  respondents .air.
 leged in their answer that  the literature accompanying the  unit
 contains a specific disclaimer that it does  not kill bacteria.
   We conclude from  the  evidence that respondents'  water purifier
 does not in 'fact remos'e  water-borne  micro-organisms  or  viruses
 capable of causing diseases. Moreover, we hold that the statements
 in respondents'  advertisements and  form letters  that their  unit
 will /'purify and  filter" water, will ensure "clean" water, will  cor-
 rect "bad"  water,  will  give "pure  drinking and  cooking  water"
 which is "vital to the health of your family" and will  filter "im-
 purities" found in the consumer's water  supply constitute repre-
 sentations  that  respondents' unit will remove bacteria and other
 disease-causing germs.  \Ve  find that a  potential purchaser  who
'has  or  believes  he has or  may  have contaminated water could
 easily be led ,by statements of the type quoted  above to  believe
 that respondents' unit  will make his water potable. Gian^Foods_,
 Inc. v, F.r.C. 332 F. 2d 977 (1963).      .    -       " ""  -. ~
   With  respect to the disclaimer  used by respondents in one  bro-
 chure, we have no way of knowing  from the evidence whether all-
 of respondents' prospective customers actually received this pam-
 phlet. Furthermore, this ciiscL-.irr.er was not inserted until respond-
 ents' precornplaint negotiations with complaint counsel. Finally, the
 presence of this  disclaimer '.-.   ::s of respondents' brochures does
 not negate the cor.tr.iry ::r.v    'i-.-n ir. the r.ffirmativc representa-
 tions contained  in their au%i  . -.  or.ts and  sales literature as to
 the purifying qualities of their  unit.

-------
 c:r. jrart cr  iucoar-  u:   Guidelines  for Recistratien -of  Pesticides  r
 a  S;a:2s:  rrccuct Perfor.  inca  Stancards (pg*  14.5-146).   (Full tsxt
  frr.T, .U.ecdquurt5rs.}              '                             .:.


 elements: representative levels of organic-and inorganic soil

 contamination; various wacer temperatures; Che specific  dosage
              * .
 and exposure period recocmended for the proposed produce; a

 variety of test aicroorganises representative of the  target  pests
                                                     rt
 to be controlled; and quantitative determination of the  level of

 oicrobial contaainacion of the vater before and after treatment.

   (ii)  Performance standard.  The treatment oust eliminate  all

 tect cicroorganiszis frca the vater.

   (3)  Vater treatment units,  (i)  Vater purifier units. Any unit

 intended for the treacaenc of rav water to elininate  the potential

' health hazard posed by nicroorganisas is identified as a water

 purifier.  The unit aay rely on physical filtration* (pesticidal

 device), or chesical treatment (pesticide), or a coabinaticn thereof,

 to achieve the intended purpose of purifying aicrobiologically ncn-

 potable vater by eliminating watar-bome pathogens in the water

 itself.  Those units, such as subaicron aeabranes and absolute filters,
                                                
 which rely solely en a physical aeans for reaoval of  aicroorganisas

 fron vater, are identified under the Act as devices,  and are subject

 to regulation but not registration.  The test requirenents indicated

 below are for the units containing an antinicrobial agent.

   (A)  Test standard.  Controlled siaulated-use studies  for  the

 water purifier ur.it aust be conducted under conditions representing

 actual use employing a defined raw water source containing a high

 level of aicrabiological pollution.  The test design  wil  vary
                               145

-------
vieh different  types  of units  and  patterns of use, buC oust include


auch basic elements as: representative  levels of organic and in-
              * 

organic soil contamination;  various water temperatures; docuaen-


tation of the antimicrobial  concentration found is the test system;


and quantitative  determinations  of the  oicrobial contaaination


level of the water before and  after passage through the unit.  The


duration of effectiveness or effective  capacity of the unit before


a replacement is  necessary oust  be documented.


  (B)  Performance standard.  The  treatment oust elisinate the


aicrobial pollution in the rav vater.


  (li)  Potable vater'treatment  unit.   Any unit intended for physy


ical and/or chemical  treatment of  aicrobiologicaliy potable vater


from a municipal  treatment facility to  remove undesirable tastes


odors, cheaicals, or  other aesthetically objectionable properties


is Identified as  a potable vater treatment unit.  A substrate such


as activated charcoal (with-  or without  a bacteripstatic agent) is


incorporated into the unit for this terminal processing treatment


of potable vater  prior to consumption.  Since the requirements of


the Safe Drinking Vater Ait  do permit aunicipally-treated drinking


vater to contain  a liaited number  of harmless "saprophytic" bacteria


vaich are cozaonly recognized  contaminants of vater, an antimicrobial


agenc is sometimes incorporated  in a potable vater treatment unit


to provide bactariosnatic activity against these contaminants.  Only


potable vater treatment units  containing a bacteriostatic agent are


urder the purview of  the Act.
                                 146'

-------
Exerpt  fror.  In re Contact Industries.  Inc. (pg. 6-8).   (Full  text of document
available  from headquarters.)
                     ENViROn:-:r.:ttAL PROTECTION AGENCY
                    BEFORE THE REGIONAL  ADMINISTRATOR
     In re                                  )                 '   '
            Contact  Industries,  Inc.,       )     l.F.  &  R.  Docket  No.  II-1S6C
                         Respondent        )          Initial  Decision
          The term purifier connotes  a  product  which  eliminates  impurities
     and polluting natter.  V.'e are  in agreement with  the  conclusion  of
     Complainant's expert witness that  the  "word ourifier is  suffir.ini--'Hv
     broad  to induce ridding the air of oh.icctionables,  includinq roirro-
     orgc-nisr.is as they would exist."  An air purifier would  therefore
     cleanse the air of air-borne b?.cteria, virus,  and fungi  particles.   If
     Respondent had  intended for the  product to be  understood to be  merely
     an air freshener or deodorizer,  the label  could  have contained  the
     term air freshener  (cf. Respondent's Ex. 7) or been  limited to  the
     -claim  that the  product was an  industrial odor  absorbent and nbt also
     a glycolized air purifier.   In fact, the latter phrase  would be
     somewhat redundant  in the context  in which it  is employed on the
     label  if all that was intended thereby was to  inform the consumer
     that the product functions as  an air freshener.   As  indicated  by
     Complainant's expert witness,  the  term air purifier  especially  when

-------
                          .   - 7 -

taken together with the word "Sanicidc"  on the label  would indicate
that thti pro-Jjcl is intended to rid the  air of genus, that is,
bacteria or viruses.
                                                         m
     "Sanicide" is printed in bold-face, conspicuous  type on the front
of the label.  The word also appears at  the top of the back of the
label in type which is in larger and bolder print than all other words
on that side of the label.  It is clear  that the word "Sanicide" is
meant to provide the most conspicuous reference to the product.
     "Sanicide" implies both a sanitizing and a killing action or, at
the least, a killing action.  Sanitize means to free  from dirt, geras,
etc., as by cleaning or sterilizing.  The suffix -cide means killer
or killing.  Ses Lobster's Third Mew International Dictionary  (19G5).
A consumer would, we believe, recognize  the meaning of the suffix
-cide as is evidenced by the corunon usage of words such as homicide,
pesticide, and  insecticide.
     In interpreting broad remedial legislation, the  consumer  is not
assumed to be an expert or one possessing special knowledge or
ability, and includes "the ignorant, the unthinking,  and the credulous."
Unite:! States v. An Article. .  .Consisting of 216 Ortonsd Cottles,
supra at p. 740 and cases cited therein; United States v. An Article
of Drug. . .47  Shipping Cartons.  .  .. 331 F.Supp. 912, 917 (D.  Md.
1971).  Her can we assume that  the buying public will exercise great
selectivity and caution in what they choose to believe: of what they

-------
                                -  Li -

re?.d.  Unitiu  Str.tes  v.  Articlcr.  of Drug.  Etc..  263 F.Supp.  212 (D.
Neb. 1CG7).  Cf.  Hclhros Watch Co-.rp.inv v.  Federal  Trade Cc:rm'r,sicn.
310 F.2d 863,  , 859  (D.C.  Cir. 195?.),  cert,  denied 372 t>.S.  976
                                                           *
(1552), rehearing denied 374  U.S.  857  (19G3), and  coses cited therein.
A consumer would  be justified in  believing that  the product he purchased
had the capability of both cleansing the area sprayed (sanitizing) and
killing microorganisms present in the  area sprayed.  This is especially
so when the  term  "Sanicide" is read in conjunction with representations
that the product  is an air purifier or a glycolized air purifier.
Certainly, the use of the prefix  sani- with the  suffix -cide has
greater significance  than the use of that prefix in other contexts
disclosed  in the  record.
     Antimicrobial agents are specifically included as one of the
classes.of sanitizers or pesticides subject to registration under  the
/~t    (a crtrH^r, 1 r? ")f-?#l  * + ^~ r^..i - <-~ -. - -  '40 /-" ; <; If^f^V,
MWU.   ^ **.- *i. W  I wi t  vb- . w I  * j  w* .^*lt. tV_^UIUCIVJM.3  ^*TOv^l l\  IUC.^^1 t  J J J 
The claim  that the product Superior Sanicide Air Purifier is an air
purifier when  read in conjunction with the word  "Sanicide" would  indi-
cate that  the  product is indeed an antimicrobial agent "intended  to
reduce the number of  living bacteria or viable virus particles on
inanimate  surfaces,  in water, or in air", in this case.  See 40 CFR
                                        y
162.3(ff)(2)(i)(B) (Emphasis  supplied).    Thus, representations rcao'e
      I,/  Microorg;'.:)-;t:iij,  including but not limited to algae, fungi,
and bacteria,  and  viruses have been declared by the Ao  cnvirot::;!int (Sec 40 CFR 162.14(b)(4) and (5.)).

-------
.^f^\      UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
        ?                    WASHINGTON. D.C.  20450


                               JUN   8 198!
                                                      OFFICE OF ENFORCEMENT
      MEMORANDUM

      SUBJECT:   Child  Resistant  Packaging Requirements  for Pesticides
                -  Enforcement  Strategy  and Penalty Policy
                                                                   %
      TO:        Enforcement  Division  Directors
                Pesticide  Branch Chiefs


           On  March  9,  1979, the Agency published  a final rule which
      requires  certain  pesticides labeled for  residential use to be
      packaged  in  Child Resistant Packaging (CRP)  if released for
      shipment  on  or after March 9,  1981.

           The  CRP enforcement  strategy document,  which is attached,
      stipulates that  states operating  under  grants will  be responsible
      for  conducting inspections to  determine  compliance  with the CRP
      requirements.   This  activity should be  incorporated into their
      routine  establishment  inspection  program.   The regions will be
      responsible  for  coordinating the  program  and initiating enforce-
      ment actions for  CRP violations with PTSED's concurrence.   The
      reasons  for  this  are:  1)  violations of  the  CRP requirements
      are  not  violations of  pesticide statutes  in  many  states, and
      2) a need for  close  coordination  with the  Office  of Pesticide
      Programs  during  the  initial  stages of the  program.

           The  strategy document should be distributed  to states with
      a  cover  letter from  the  appropriate office within your region
      explaining the specifics  of the program.

           If  you  have  comments  or questions  on  the strategy document,
      please  contact Phyllis Flaherty  (755-0970) of my  staff.

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                           - 2 -

     I am also attaching an amendment to the Guidelines for
Assessing Civil Penalties pursuant to FIFRA.  This amendment
adds violations of the CRP regulation to the Civil Penalty
Matrix and provides guidance on appropriate enforcement
actions for CRP violations.

     Comments or questions on the amendment should be addressed
to Patricia Mott (755-9404) of my staff.

     Also attached are copies of the applicable Federal Register
notices.
                               A. E. Conroy II,I D4rector
                            Pesticides and Toxi^/Substances
                                 Enforcement Division
Attachments

-------
                STRATEGY FOR THE ENFORCEMENT
              OF THE CHILD RESISTANT PACKAGING
                   REGULATION UNDER FIFRA
OVERVIEW

REQUIREMENTS OF THE RULE

     Applicabi1ity
     Exceptions
     Exemptions
     Specific Requirements

REGULATED  INDUSTRY
ENFORCEMENT

     Objecti ves
     Voluntary Compliance
     Viol at ions
     Inspection Scheme
     Violation  Detection Priorities

ADMINISTRATIVE CONS IDE-RAT IONS

     Program Management and Allocation of Responsibilities
     Program Integration

-------
 t_r-a.tJL9jy_ f  rt h e _Ejrf p r_ce m e nt ^_o_f t^h e_ C h 1 l_d_R_e_s_1 s t a n t
 aCJK.a_gi_1_nj^je g uTa~t i^n"U n dTr' ""  """"

Overview
    On March 9. 1979, the Environmental Protection Agency
published a final  rule at 44 FederjJ Register 13019 (40
CFR 162.16) which requires chlfd res'istant packaging  (CRP)
of certain pesticides labeled for residential use.  The
intent of the rule 1s to reduce the number of accidental
exposures by children to pesticides.

    The regulation requires child resistant  packaging  for
any pesticide product released for shipment  after March  9,  1981,
if (1) its labeling allows for^residential use.  (2) it .has  not
fceen classified for restricted use, and (3)  it meets certain
toxicity criteria.  Exemptions may be granted for products
for which special  packaging is not technically feasible  or
where the toxicity criteria are not Indicative of hazard to
humans .

    The rule also requires affected registrants  to submit
applications for amended registration and maintain records  on
child resistant test data.

    Possible violations include misbranding, failure  to  keep
records, failure to file reports, and falsification of data.

    It is anticipated that states operating  under grants will
have major responsibility for conducting  inspections  concerning
the CRP requirements.  The Regions will handle the casework  since
these types of violations would not be in violation of many
State statutes.  Concurrence from PTSEO is required for  enforce-
ment actions resulting from violations of the CRP regulation.
Headquarters support will be available for data  review and  to
answer questions on whether or not a product meets the criteria
that trigger the requirement for child resistant  packaging.
In addition, PTSED will provide inspection targeting  information.

Requirements of the Rule
Applicability

    As indicated  in the overview,  child  resistant  packaging  is
required for any  pesticide product  released  for  shipment  after
March 9, 1981,  if  (1)  its  labeling  allows  for  residential  use,

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                            -2-


(2) it has not been classified  for restricted use, and (3) it
meets certain toxicity criteria.  In addition, registrants with
products subject to the  rule must amend their registrations to
reflect changes 1n packaging and certify that the packaging
complies with the CRP regulation.

    For your Information certain terms used 1n the Strategy have
been defined below:

    0  "Released for shipment"  is defined as that point in time
        when it is the intent of the producer to introduce the
        product Into commerce.   Intent exists in any of the
        following situations:

        (1) a producer asserts  that what is being sampled is
            representative  of what is actually sold;

        (2) a product is stored  in an area where finished
            products are held for shipment in the ordinary
            course of business  (warehouses, loading docks,
            etc.);

        (3) the custom of the pesticide chemical industry
            indicates that  similarly situated products are
            intended for release; or

        (4) the custom of the particular producer indicates that
            similarly situated  products have been intended for
            release in the  past.


    0   "Residential use" - A pesticide meets this criterion if
        it is applied (other than by a commercial applicator)
        directly to humans  or pets or is applied in, on or
        around all structures,  vehicles, or areas associated with
        the household or homelife or noncommercial areas where
        children spend time, including, but not limited to gardens,
        houses, yards, patios,  mobile homes, campers and
        recreational vehicles,  noncommercial campsites, home
        swimming pools,  educational, lounging, and recreational
        areas of preschools, nurseries, and day camps, etc.
        Furthermore, residential use is determined by whether
        a product has a  use on  the label which is within the
        meaning of residential  use.  A registrant may have a
        product that Is  not really Intended for residential
        use, but the labeling is either vague concerning use
        areas, or use areas are  actually omitted.  Such a
        product is subject  to the child resistant requirements
        unless its registration  and label are amended to indicate
        a strictly non-residential or agricultural application.

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                              -3-
    0   "Toxlcity criteria" are defined in 44 Federal  Regi ster
        13019 (March 9,  1979) and at 40 CFR 162.16(C)(2).

Exceptions to CRP

    0   "Dormant" Product Registration

        A dormant product registration is defined as  a  product
        which is not currently in production but retains  valid
        EPA registration.  For a product not in production  and
        which is not scheduled to be released for shipment  on
        or after March 9, 1981, an amended registration,
        special  packaging certification and other related
        forms need not be submitted at this time.  However,  at
        any time after March 9, 1981, if the product  is put  back
        into production,  an amended registration, child resistant
        certification, etc., must be submitted before  the
        product  is released for shipment if it meets  the
        criteria for special packaging.

        Toxicity Data

        If the toxicity  of a product is not known to  the  level of
        specificity necessary to determine whether or  not  the
        toxicity criteria are met (e.g., the information  on  file
        with EPA is extrapolated data), the registrant  may  perform
        additional testing.  If testing indicates that  the  toxicity
        criteria are not  met, the product is not required  to
        have child resistant packaging.  However, if  the  regis-
        trant does not conduct further testing when the toxicity
        is not known to  the necessary level of specificity,
        child resistant  packaging is required.

    0   Products for Residential Use by a Serviceperson

        The Agency has decided to remove from the scope of  CRP
        requirements certain products which meet the  criteria
        for special packaging but are not normally stored  in
        areas where children could likely have access  to  them.
        Examples include  products used by janitors in  nurseries
        or daycare centers and products used by exterminators  or
        lawncare servicepersons.  To accomplish this,  EPA  will
        allow products such as those listed above to  be sold and
        distributed without child resistant packaging  if  such
        products bear a  statement restricting the sale, use, and
        S-Loraae  to_s_fi_rv icejjerSOILS^

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                             -4-


        This provision has been communicated to producers
        through a Federal Register Notice Issued March 3, 1981;
        it will also appear in proposed revisions to Section 3
        Registration regulations.  Until it appears in final
        regulations, EPA will use .prosecutorial discretion and
        not take enforcement action if a subject product is
        not specially packaged but is labeled or sticker-labeled
        with a statement restricting the product's sale, use,
        and storage to servicepersons, e.g., "Only-for Sale
        to, Use, and Storage by Servicepersons."  The statement
        must appear in type size at least as large as the
        child hazard warning statement.  Labels need not be
        submitted to the Agency for approval but must be submitted
        for the official label file used to determine compliance
        with FIFRA.

    0   A registrant may amend his/her registration so that
        the new label does not allow for residential uses.
        In such a case the product bearing the new approved
        label would no longer be subject to the special  packag-
        ing requirement.

Exemptions to CRP

    Exemptions may be granted by the Director of the Regis-
tration Division for products for which special packaging is
not technically feasible or where the toxicity criteria  are
not indicative of hazard to humans.

    Note that only the Agency may grant an exemption.  It is
not up to the registrant to decide if he or she is exempt
or not, based on the two factors listed in the above paragraph.

Specific Requirements for Registrants of
Products Subject to the Special Packaging Requirement

    0   Develop and test special packaging

        "Special packaging" refers to packaging that is  designed
        and constructed to be significantly difficult for
        children under five years old to open or obtain  a
        toxic or harmful amount of the substance contained
        therein within a reasonable time.  In addition,  it
        should not be difficult for normal adults to use pro-
        perly.  Effectiveness testing procedures which must
        be used are those specified by the Consumer Product
        Safety Commission (CPSC) at 16 CFR 1700.20(a), (b),
        and (c).  Effectiveness specifications and standards
        for special packaging are delineated in 40 CFR 162.16.

    0   Amend registration - Certification

        Prior to changing a product's packaging, the registrant
        must submit an application for an amended registration
        and have it approved by EPA.  Instead of submitting

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                       -5-


detailed information demonstrating that the packaging
meets the requirements, the registrant shall  Include
with his application a certification that the package
meets the standards of 162.16(d).  An applicant for
a new registration shall also submit a certification
statement that the package meets the standards.

UtJLlize special packaging

Products subject to the requirement must be in child
resistant packaging if released for shipment  after
March 9, 1981.

Recordkeeoinq.

Certain records must be retained by the applicant or
registrant for as long as the registration is valid.
These records shall be available, upon request,  for
inspection and copying purposes or for submission
to EPA.  The  records which must be kept are:

(1) A full description of the package including:

    (i)  A full description of the container  including

         (A)  Its dimensions, and
         (B)  Its composition; and

   (ii)  A full description of the closure or special
         package, if appropriate, including:

         (A)  The name of its manufacturer,

         (B)  The manufacturer's designation  (title)
              for the special packaging closure  or
              the physical working of the special
              packaging mechanism, and

         (C)  The explicit directions for proper use
              of the closure or special packaging
              and the placement of these directions
              on the package;

(2)  A complete copy of the data resulting from  the
     tests conducted in accordance with 162.16(d);
     and

(3)  Data demonstrating the compatibility of  the
     pesticide formulation with the entire package to
     determine that the chemical and physical charac_-___
     teristics of the substance will  not interfere
     with the safety and efficacy of the pesticide
     and functioning of the special package.

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                             -6-
Note:  The registrant may not have actual  data
      company did not perform the testing but
      on verification from others such as the
      produces the packaging.  The registrant
      letter or literature verifying that the
      been tested and met the CRP standards.

Regulated Industry
                         on  file  if the
                        ,  instead, relied
                         company  which
                         should have  a
                         packaging has
    The regulated community consists of registrants of those
products subject to these regulations.  Estimates suggest  that
approximately 9000 products may be involved.

    The Registration Division of EPA has prepared a pre-
liminary list of types of products which are expected to be
covered by the CRP regulations if used and stored in and around
residential areas.  (See attachment.)  A second, more complete
list will be developed and forwarded as soon as it is available.

    A company may remove its product from these requirements  by
amending the label to remove residential uses, stickering  or
amending the label so that sale, use and storage is restricted
to a serviceperson, or by receiving an exemption.

Enforcement
Objectives

    The objective  is
so as to minimize  or
poisonous pesticides

Outreach
to assure compliance with this  regulation
eliminate accidental exposures  to  highly
used in and around residential  areas.
    Registrants  should  be  aware of the
publication in the  Federal Register.
Packaging  Institute prepared and
concurrence, a pamphlet entitled,
Packaging."  Personnel  in  the
                  regulation through its
            	   In addition,  the  Glass
            dTstributed, with EPA's
             "Pesticides and Protective
         Registration Division  are  generally
available to answer any questions and clarify the requirements
for registrants.

Violations

        Mjsbranding -  12(a)(l)(E)  of FIFRA
             As  defined  in  2(q)(l)(B)  of  FIFRA, a pesticide 1s
        misbranded  if "it  is  contained in a package or other
        container or  wrapping  which  does  not conform to the
        standards established  by  the Administrator pursuant

-------
                    -7-
 to   2 5(c ) (3 )."   Failure  to have  special  packaging
 for those  products  released  for  shipment  after  March
 9,  1981,  would  make the  product  misbranded  if  it  is
 subject to the  special packaging requirement.

     There  are three variations  of this  violation:

          (1)  No  special  packaging,  although required.

          (2)  Company's  new  toxicity test data  indicate
              that  such  packaging is not  required, but
              the Agency does  not agree  that the
              toxicity data  support  their conclusion
              (e.g.,  improperly  conducted toxicity
              tests or incorrect toxicity tests
              utilized).

          (3)  Company  changes  packaging,  but it does
              not meet the child resistant  requirements
              because  tests  were incorrectly done or  the
              tests were  conducted on the incorrect
              container  size.


 Failure to File  Reports  Required - 12(a)(2)(N) of FIFRA

     It  is  unlawful  for a  person  who  is  a  registrant to
 fail to file  reports  required  by this Act.  Prior to
 changing  a pesticide's packaging, the registrant
 must submit an  application for  amended  registration to
 EPA.  Failure to  do so prior to  distributing the product
 in  new  packaging  would be  in violation  of this  section.

     In  addition,  the  registrant  is required to
 submit  a certification statement with the amended
 registration  application.

^Failure to Maintain Reports  Rpqnirpri -  12(a)(2)(B) of FIFRA

     It  is  unlawful  for a  registrant  to  fail to maintain
 reports required  by FIFRA.  The  regulation  requires
 the registrant  to submit  a certification  that the
 product is in compliance  as  opposed  to  detailed  data
 supporting this.  However, it  is required that the
 detailed  data be  maintained  and  be subject  to Agency
 inspection or request  for  submission.   The  registrant
 is  not  required  to  have  such data on file if the firm
 relied  on  testing conducted  by others such  as the package
 supplier.  In lieu  of  such data  he or she must  have
 some verification on  file  that the product  is in compliance.

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                            -8-


            In some cases, the company may claim that the  parent
        company/company headquarters has the data.   This should
        be noted on the inspection report and sent  to the
        appropriate region.  The regional office should  forward
        this to PTSED so that a request  for the data can be  sent  to
        the company's headquarters by OPP.

                      of Application/Report or of Records
        taintainednjr of Exemption Request - 12(a)(2)(M)  of
        FIFRA or Title 18 of the U.S. Code.

            It is unlawful to falsify all or part of any appli-
        cation for registration, any records required to be
        maintained pursuant to 8, or any report filed under
        this Act.  Thus, falsification of an application for
        amended registration, the certification, or data such  as
        test protocol and results would  be in violation  of FIFRA.
        Title 18 of the U.S. Code also makes this type of  activity
        i1 legal.

INSPECTION SCHEME

    Inspections to determine compliance  with these  special  packaging
requirements should be incorporated into a state/region's  existing
inspection program, which should be based on a Neutral Administra-
tive Inspection Scheme.  Generally, only producer establishments
will be inspected for compliance with the CRP regulation.   Prior
to inspecting a pesticide producing establishment,  the appropriate
personnel   (inspector or whomever is designated to do this)
should determine if the company produces any of the products
on the attached list prepared by the Registration Division.
If so, the inspector should check for compliance with
the child  resistant requirements.

    Reports from inspections involving possible violations of
these requirements should be forwarded to the regional office
for case review and appropriate enforcement action.

Violation  Detection Priorities

    During an inspection, it is helpful  to establish priorities
for detecting violations.  The fol1 owing tab!e gives the general
priority  ranking for violation detection.  The following  is
meant only as a guide to decision making and is not a rigid  OE
p o1 icy.

Priority  1 - Misbranding

    Failure to utilize Child Resistant Packaging where required.
This will   probably be the most common violation found initially.

-------
                              -9-


Priority 2 - Failure to Maintain Records

    Such records may be necessary to verify compliance with the
regulations.  This includes test data which either (a) show the
package meets the child resistant requirement (CPSC test results)
or (b) show the product's actual toxicity does not meet the
criteria.

Priority 3 - Failure to File Reports

    This refers to a company's failure to amend the registration
prior to a packaging change.  This should not be a frequent viola-
tion but is easy to determine.

Priority 4 - Falsification of Data

    While this is one of the most serious violations, it should
not be encountered frequently.  Child Resistant Tests are
expensive (approximately $8000)  and may be conducted under
contract if a company's test results are suspect.

ADMINISTRATIVE CONSIDERATIONS
PROGRAM MANAGEMENT AND ALLOCATION OF RESPONSIBILITIES

    State and regional personnel if appropriate will  be responsi-
 le for conducting inspections and documenting cases.

    With regard to actual casework, issuing penalties, notices of
warning, etc., the regions will have primary responsibility but
must request and receive concurrence from PTSED.
This is necessary for 3 reasons:

    1)  A violation of the child resistant requirement
        is not a violation of many state laws.

    2)  Some companies may have received exemptions or
        the product may not be subject based on toxicity data
        on file with EPA.

    3)  The Registration Division may consider cancellation
        action for those products which remain in violation.

    PTSED's Case Development and Legal Branch will be respon-
sible for resolving questionable cases, i.e., those for
which there is some doubt or question as to the product's

-------
                             -lo-


st a t u s or the v a 1 1 d 1 t..'  of  the fl a t a ,  ^ n < I r r? v i ow i n n concurrence
requests.

Program In t e_g ration

    The Case Development  and  Legal  Branch, PTSEO, will coordinate
with the Regions and the  Registration Division to resolve any
questions regarding  the child resistant packaging requirement
and the status of products covered.

    The Regions will coordinate with the States regarding the
enforcement of the  special packaging requirements.

-------
              UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C. 20460
                                                                     OFFICE OF
  MEMORANDUM                                               PESTICIDES AND TOXIC SUBSTANCES

  SUBJECT:   Enforcement  Strategy Concerning Child-Resistant Packaging of
             Pesticide  Products.

  TO:        Jack  Neylan
             Pesticide  Toxic  Substances
             Enforcement  Division (EN-342)

  As a  follow-up  to our  recent meeting concerning an enforcement strategy
  on compliance with CRP regulations we are providing to you a list of
  generic products for which an  unqualified assumption can be made that
  they  need to be in CRP if  used and stored in the household.  This is con-
  sidered phase I of the strategy.   Phase  II will consist of a more refined
  list  which will be based on the actual CRP amendments we receive.

^ 1.  Disinfectants

  Product              Concentration            Use

  1.  Calcium
      hypochlorite        65%                 swimming pool

  2.    Lithium
        hyprochlorite      35%                 "

  3.    Sodium dichloro
        s- triazine trione
        and  Trichloro-s
        triazine trione    98-100%              "          "

  4.    Mono (Trichloro
        tetra (monopotassium
        dichloro)  penta-s-
        triazinetrione      99%                 Swimming pool

  5.    Hydrochloric acid  8%                  Toilet bowl

  6.    Phosphroric acid    17%

  7.    Chlorophenolics    6%                  Disinfectant

  8.    Sulfamic Acid      20%                 Toilet bowl

  9.    Quaternary Ammonium
        Compounds  	   105                 General disinfectant

  10.   Paraforcaldehyde    95%                 "          "

  11.   Formaldehyde       37%                 "          "

-------
2.   Ips^c^cide and Rpdep^icide

Pesticide Chemical       % At and Above Requiring CRP

1. Carbophenothion                 1.4
2. Chlordane


3. Chlorpyrifos  (Dursban)


4. Cryolite

5. Diazinon



6. Dimethoate  (Cygon)

7. Disulfoton  (Disystox)



8. Dyfonate

9. Ethion


lO.Imidan

ll.Lindane


12. Metaldenyde


13. Mexacarbate  (Zectran)


14. Naled

15. Propoxur  (Baygon)

16. Phosphorus  (white)
28.0


9.0


15.0

7.0



17.0

0.4



1.2

3.5


10.0

6.5


20.0


2.0


18.0

6.2

1.1
     Remarks

Some lawn use
products

Termite control
products

Sprays for outdoor
Ornamentals

Plant dusts

Many plants and garden
sprays; encapsulated
diazinon does not require CRP
Systemic insecticides
for indoor and outdoors
plants
Some combinations with
lawn fertilizer
Borer sprays, dog
dips

Slug and snail
control

Insect, slug and
Snail control
Rodenticide

-------
3*
Chemical                 Formulation / % A.I.

Bis (tributyltin) oxide       Above 0.5%

Paraquat                      any %

Pentachlorophenol             above 88%

Chlorothalonil                above 40%

Copper-8-quinolinolate        above 5%
  bo Engler, (finief/y
Disinfectants Branch
Registration Division (TS-767)


cc:  D. Campt
R. Gross
J. Jenkins
H. Harrison
J. Akerman
                                                       Use

                                                  Wood Presenvative

                                                  Homeowner herbicide

                                                  Wood preservative

                                                  Homeowner fungicide

                                                  Wood preservative

-------
General  Compliance  Strategy  for Products  Subject  to  the FIFRA
                  Label  Improvement  Program

0 ve rvlew
     On  June 5,  1980 EPA published in the Federal  Register (45 FR
37884)  a notice  initiating a program to improve pesticide labeling.
The Label  Improvement Program (LIP)  was initiated  to upgrade pro-
duct labeling in an attempt  to better protect health and the environ-
ment as  well as  further defining legal  use of a product,  this program
was designed to  work in conjunction  with  currently existing registra-
tion programs and to respond rapidly to labeling  needs identified by
the Agency.   To  date, four major label  improvement program notices
have been issued and are in  effect.   Two  additional  label improveme'nt
program  notices  have been recently issued but are  not yet in effect.

Regulated Industry
     Some label  improvement  rules affe.ct  all  registrants, while
others  affect only  registrants of certain products.

Requirements of  the Rule
Submission of Applications	
     The Office  of  Pesticide Programs (OPP),  Registration Division
(RD) will  notify each registrant of  an  affected product by certified
letter  or a  certified mail copy of a PR Notice that  his product is
subject  to specific requirements under  that label  improvement program
revision.   For each affected product, the registrant is required to
submit' the following to EPA:
     1)  An application  for amended registration (E.PA Form 8570-11).
     2)  Five copies of  draft labeling incorporating  required changes.

-------
     3) If necessary, a Statement of Confidential  Formula  (EPA  Form
        8570-4).
     Registrants must normally submit applications within  60
calendar days of receipt of the LIP Notice.  The Agencj  will state
any deviation from this deadline in the LIP Notice.
     Products for which the Agency has not received an application
for amended registration within the stated deadline will  be subject
to cancellation.  The Agency will issue a Notice of Intent to Cancel
for any such product, effective 30 days from its receipt,  unless
within that time the registrant or an interested party with the
consent of the  registrant, either applies for amended registration
or requests a hearing under section 6 of FIFRA.
Exemption from  Compensation Requirements	
     In many cases an amended registration to meet the requirements
of a Label Improvement  Program Notice will not- be subject  to com-
pensation requirements.  If this is the case, the Offer to Pay or
Certification Statement will not be required to be submitted to RD
and approval of labeling submitted will not convert registrations
to conditional  status.  Each notice will address the compensation
status of applications  submitted in response to the LIP Notice.
Processing of Applications	
     Generally, the  Registration Division will  review labels
for compliance  witji  the requirements of the LIP Notice.   A regis-
tration amendment submitted in response to a LIP Notice is not
complete until  the amended labeling is submitted and accepted by
RD.  If draft labeling  is not acceptable, RD will  notify the
registrant of the deficiencies by letter and give the registrant
75 calendar days to  submit amended labeling.  Amended labeling

-------
                              - 3 -
must be limited to changes  required by  the  letter in  order to
maintain the exemption  from compensation  requirements.
Combined Application  in Response to Multiple Label  Improvement
Noti ces
     Applicants receiving multiple notices  requiring  LIP  labeling
amendments for the same product may combine responses into one
application for amended registration provided the relevant LIP
Notices are clearly referenced.  Applications that  are  non-compen-
sable under FIFRA section 3(c)(l)(D) may  not be combined  with
     X
applications that are compensable.  The submission  deadline for
combined applications for amended registration is the later of
the deadlines established in the LIP Notices.
Time Frames for Compliance	
     Any product released for shipment  180  calendar days  after the
registrant receives RO's acceptance of  amended labeling must bear
that accepted label.   Registrants are responsible for compliance
by their sub-registrants (distributors).
     Products that have been released for shipment  and  are in
retail  channels of trade prior to the 180 day deadline  may continue
to be distributed in  commerce, sold and used until  supplies are
exhausted.

Enforcement Objectives

     The objective of LIP compliance program is to  ensure that
product labeling is in  compliance with  the  requirements of the
various Label Improvement Program Notices.   This  will be  accom-
plished through producer establishment  inspections.

-------
                                - 4 -
Typesof Violations
     Producers not complying with the requirements of .the notices
                                                      *
issued under the Label  Improvement Program are in violation  of
of FIFRA section 12(a)(l)(E) in that their products are misbranded
under sections 2(q)(1)(F) and  (G).  Products being sold in violation
of a cancellation order are in violation of FIFRA section 12(a)(2)(L)
and subject to the penalties thereunder. -
           x
Administrative Considerations
     The Office of Pesticide Programs has issued four major  label
improvement notices  (See Attachments) which are currently in effect
with two more LIP Notices issued but not yet in effect.  The four
existing LIP Notices  are listed below in order of inspectional
targetting priority  according  to their potential hazard.
     1) Fumigants -  Issued  12-4-80 - This LIP Notice requires
registrants of products containing certain active ingredients to
add additional precautionary labeling, misuse statements and storage
and disposal statements.
     2) Termiti ci des  -  Issued  11-7-81 - This LIP Notice requires
registrants of termiticide  products containing one of the active
ingredients listed in the LIP  Notice to revise use directions of
their product, use the  appropriate storage and disposal statements,
add a misuse statement, and reformat their labels.
     3) Antlfoul Ing  Pai nts  - Issued 3-9-82 - This LIP Notice required
registrants of all antifouling paints to make extensive revision
of their product's labeling.

-------
     4) Salt Water Emesi s - Issued 11-30-80 - This LIP Notice
  
requires all registrants  to delete salt water emesis statements

from their labeling.  Since the revision was a simple del etion,
                                                     
registrants were not required to submit amended labeling for review,

     Two more LIP Notices have been recently issued dealing with

worker reentry Intervals  and disposal requirements.  As they become

effective they will be included for targetting in  the inspectional

program.

Targetting Inspections	^	
                                                           *

     The Registration Division, OPP is responsible for compiling

lists for each LIP Notice consisting of:

     1) The name and address of each registrant affected;
     2) The name and registration number of each product affected;
     3) The registration  status of each product affected,  i.e.,
        compliance, pending, or subject to cancellation; and
     4) The date of acceptance of the amended labeling if  the
        product is in compliance.

These lists, which the Compliance Monitoring Staff will forward  to

the Regions, will be a basis for the States' or Regions' inspection

targetting.

      States should target inspections* based on the priority as-

signed to each LIP Notice in this document and on  the current

registration status of products regulated under each Notice.

To identify inspection targets, States should first list under

each LIP Notice the registrants andthe number of  their products

whose:  a) product labels  are subject to cancellation for failure
 Only producer establishments should be targetted for inspection
under this guidance.  Marketplace inspections are not appropriate
for determining compliance with this rule.  Products in the channels
of trade prior to the date when amended final printed labeling
must appear on a product may continue to be sold.  Therefore,  it
would not be an effective use of resources to determine the existence
of violations based on marketplace samples.

-------
                                - u -
to respond to the.LIP Notice; and b) label amendments RO has
approved.  Inspection priorities will not include registrants
whose products have label amendments pending with RD.  Priority
                                                       
for inspection should then be as'signed on the following basis:
     1) Registrants of products subject to cancellation for failure
        to respond to the LIP Notice.  These registrants should
        be ranked based  on the number of their products subject to
        the LIP Notices  in the following order: Fumigants, Termi-
        ticides, Antifouling Paints and Salt Water Emesis.
     2) Registrants with the .^ost number of products with accepted
        amended labels subjec* to any LIP Notices in the following
        order: "Fumigants, Termi ti'cTd'e'sy "Ant i foul "irrg Paints and
        Salt Water Emesis.
     After determining inspections! priorities for the LIP, the
States should integrate  these priorities with the criteria listed
in the FY 84 Cooperative Agreement Guidance for scheduling
producer establishment inspections (past violative history, products
subject to Label  Improvement Program, products subject to Child
Resistant Packaging (CRP) regulations, and Restricted Use Pesticides)
The highest priority in  scheduling inspections should be given to
those producers which meet the largest number of these criteria.

Inspections	

     Inspectors will examine products released for shipment at
the producer establishment to determine compliance with the terms
of the LIP Notice.  Registrants have 180 calendar days following
acceptance of amended.1abeling to bring the product into compliance.
Any product released for shipment after this 180 calendar day period
must bear accepted amended labeling.
     Registrants with products not in compliance with any LIP
Notice will be issued a  Stop Sale Use or Removal Order (SSURO) by

-------
                                - 7 -
the State or EPA in addition  to any enforcement  action  taken  by
   \
the State or EPA.  The SSURO  will be removed only "after the registrant
brings th-e product into compliance.  SSURO's will  not  be lifted  for
cancelled products sold in violation of a cancellation  order.
Issuance of a SSURO is an appropriate response to  non-compliance
as the LIP is designed to mitigate the risks of  handling pesticides
through labeling changes and  the registrant is given ample time
to make and incorporate these changes on the label.
Allocation of Responsibilities
Headquarters Responsibility	
a) Provide Regions with a compliance strategy for  Label
   Improvement Program,
b) Provide Regions with copies of each LIP Notice,
c) Provide list of registrants affected by a Notice,
   status of the products affected and date of accep-
   tance of final printed labeling for each product
   i n compli ance.

Regional Responsibility	
a) Provide copies of all pertinent materials to  the States.
b) Provide guidance and assistance for State enforcement
   efforts.
c) Assist in issuance of SSURO's.

State Responsibility	
a) Schedule and conduct inspections of affected  registrants.
b) Issue SSURO's to non-complying registrants.
c) Take enforcement actions where appropriate.

-------
General  Compliance  Strategy  for Products  Subject to the FIFRA
                  Label  Improvement  Program

Q ve rvi ew
     On  June 5, 1980 EPA published in the Federal  Register (45 FR
37884) a notice initiating a program to improve pesticide labeling.
The Label Improvement Program (LIP)  was initiated to upgrade pro-
duct labeling in an attempt  to better protect health and the environ-
ment as  well as further defining legal  use of a product,  this program
was designed to work in conjunction  with  currently existing registra-
tion programs and to respond rapidly to labeling needs identified by
the Agency.   To date, four major label  improvement program notices
have been issued and are in  effect.   Two  additional label improvement
program notices have been recently issued but are not yet in effect.

Regulated Industry                                                  ""
     Some label improvement  rules affe.ct  all  registrants, while
others affect only  registrants of certain products.

Requirements.of.theRule
Submission of Applications	
     The Office of  Pesticide Programs (OPP),  Registration Division
(RD) will notify each registrant of  an  affected product by certified
letter or a  certified mail copy of a PR Notice that his product is
subject  to specific requirements under  that label  improvement program
revision.  For each affected product, the registrant is required to
submit the following to EPA:
     1)  An application for amended registration (E.PA Form 8570-11).
     2)  Five copies of draft labeling incorporating required changes.

-------
     3) If necessary, a Statement of Confidential  Formula  (EPA  Form
        8570-4).
     Registrants must normally submit applications within  60
calendar days of receipt of the LIP Notice.   The Agency  will state
any deviation from this deadline in the LIP  Notice.
     Products for which the Agency has not received an application
for amended registration within the stated deadline will  be subject
to cancellation.  The Agency will issue a Notice of Intent to Cancel
for any such product, effective 30 days from its receipt,  unless
within that time the registrant or an interested party with the
consent of the registrant, either applies for amended registration
or requests a hearing under section 6 of FIFRA.
Exemption from Compensation Requirements	
     In many cases an amended registration to meet the requirements
of a Label Improvement  Program Notice will not- be subject  to com-
pensation requirements.  If this is the case, the Offer to Pay or
Certification Statement will not be required to be submitted to RD
and approval of labeling submitted will not convert registrations
to conditional status.  Each notice will address the compensation
status of applications  submitted in response to the LIP Notice.
Processing of Applications	
     Generally, the  Registration Division will review labels
for compliance witji  the requirements of the LIP Notice.   A regis-
tration amendment submitted in response to a LIP Notice is not
complete until the amended labeling is submitted and accepted by
RD.  If draft labeling  is not acceptable, RD will  notify the
registrant of the deficiencies by letter and give the registrant
75 calendar days to  submit amended labeling.  Amended labeling

-------
                              - 3  -
nust be limited to changes  required by  the  letter in  order to
maintain the exemption from compensation  requirements.
Combined Application  in  Response to Multiple  Label  Improvement
Noti ces
     Applicants receiving multiple notices  requiring  LIP labeling
amendments for the same  product may combine responses into one
application for amended  registration provided the relevant LIP
Notices are clearly referenced. Applications that  are  non-compen-
sable under FIFRA section 3(c)(l)(0) may  not  be combined with
     /
applications that arecompensable.  The submission  deadline for
combined applications for amended  registration is the later of
the deadlines established in the LIP Notices.
Time Frames for Compliance	
     Any product released for shipment  180  calendar days after the
registrant receives RD's acceptance of  amended labeling must bear
that accepted label.   Registrants  are responsible for compliance
by their sub-registrants (distributors).
     Products that have  been released for shipment  and  are in
retail  channels of trade prior to  the 180 day deadline  may continue
to be distributed in  commerce, sold and used  until  supplies are
exhausted.

Enforcement Objectives

     The objective of LIP compliance program  is to  ensure that
product labeling is in compliance  with  the  requirements of the
various Label Improvement Program  Notices.   This  will  be accom-
plished through producer establishment  inspections.

-------
                                - 4 -
Types of Violations^
     Producers not complying with the requirements  of .the  notices
                                                      4
issued under the Label Improvement Program are in violation  of
of FIFRA section 12(a)(l)(E) in that their products are misbranded
under sections 2(q)(l)(F) and (G).  Products being  sold in violation
of a cancellation order are in violation of FIFRA section  12(a)(2)(L)
and subject to the penalties thereunder. -
           x
Administrative Considerations
     The Office of Pesticide Programs has issued four major  label
improvement notices (See Attachments) which are currently  in effect
with two more LIP Notices issued but not yet in effect.  The four
existing LIP Notices  are listed below in order of inspectional
targetting priority according to their potential hazard.
     1) Fumi gants - Issued  12-4-80 - This LIP Notice requires
registrants of products containing certain active ingredients to
add additional precautionary labeling, misuse statements and storage
and disposal statements.
     2) Termiti ci des  - Issued 11-7-81 - This LIP Notice requires
registrants of termiticide  products containing one  of the  active
ingredients listed in the LIP Notice to revise use  directions of
their product, use the appropriate storage and disposal statements,
add a misuse statement, and reformat their labels.
     3) Antifouling Paints  - Issued 3-9-82 - This LIP Notice required
registrants of all antifouling paints to make extensive revision
oftheirproduct'slabeling.

-------
     4) Salt Water Emesi s  - Issued 11-30-80 - This LIP  Notice
  s
requires all registrants  to delete salt water emesis  statements

from their labeling.   Since the revision was a simple deletion,
                                                     *
registrants were not  required to submit amended labeling for review

     Two more LIP Notices  have been recently issued dealing with

worker reentry Intervals  and disposal  requirements.  As they become

effective they will be included for targetting in the inspectional

program.

Targetting Inspections	^	
                                                           v

     The Registration Division, OPP is responsible for  compiling

lists for each LIP Notice  consisting of:

     1) The name and  address of each registrant affected;
     2) The name and  registration number of each product affected;
     3) The registration  status of each product affected, i.e.,
        compliance, pending, or subject to cancellation; and
     4) The date of acceptance of the amended labeling  if the
        product is in compliance.

These lists, which the Compliance Monitoring Staff will forward  to

the Regions, will be  a basis for the States' or Regions' inspection

targetting.

      States should target inspections* based on the  priority as-

signed to each LIP Notice  in this document and on the current

registration status of products regulated under each  Notice.

To identify inspection targets, States should first list under

each LIP Notice the registrants andthe number of their products

whose:  a) product labels  are subject to cancellation  for failure
T0n lyproducer establishments should b~etargetted for inspection
under this guidance.   Marketplace inspections are not appropriate
for determining compliance with this rule.  Products in the channels
of trade prior to the date when amended final printed labeling
must appear on a product may continue to be sold.  Therefore,  it
would not be an effective use of resources to determine the existence
of violations  based on marketplace samples.

-------
to respond to the.LIP Notice; and b) label amendments RO has
approved.  Inspection priorities will not include registrants
whose products have label amendments pending with RD.  Priority
                                                       
for inspection should then be as'signed on the following basis:
     1) Registrants of products subject to cancellation for failure
        to respond to the LIP Notice.  These registrants should
        be ranked based  on the number of their products subject to
        the LIP Notices  in the following order: Fumigants, Termi-
        ticides,  Antifouling Paints and Salt Water Emesis.
     2) Registrants with the most number of products with accepted
        amended labels subject to any LIP Notices in the following
        order: -Fumigants, Termi ti'cTdesy "Anti fouTi rrg Paints and
        Salt Water Ernes i s.
     After determining inspectional priorities for the LIP, the
States should integrate  these priorities with the criteria listed
in the FY 84 Cooperative Agreement  Guidance for scheduling
producer establishment inspections  (past violative history, products
subject to Label  Improvement Program, products subject to Child
Resistant Packaging  (CRP) regulations, and Restricted Use Pesticides)
The highest priority in  scheduling  inspections should be given to
those producers which meet the largest number of these criteria.

Inspections	

     Inspectors will examine products released for shipment at
the producer establishment to determine compliance with the terms
of the LIP Notice.  Registrants have 180 calendar days following
acceptance of amended labeling to bring the product into compliance.
Any product released for shipment after this 180 calendar day period
must bear accepted amended labeling.
     Registrants  with products not  in compliance with any LIP
Notice will be issued a  Stop Sale Use or Removal Order (SSURO) by

-------
                                - 7 -
the State or EPA in  addition to any enforcement action taken by
   *
the State or EPA.   The SSURO will be removed only 'after the registrant
brings the product into compliance.  SSURO's will not be lifted for
cancelled products sold in violation of a cancellation order.
Issuance of a SSURO  is an appropriate response to non-compliance
as the LIP is designed to mitigate the risks of handling pesticides
through labeling changes and the registrant is given ample time
to make and incorporate these changes on the label.
Allocation of Responsibilities
Headquarters Respons i bi1ity	
a) Provide Regions with a compliance strategy for Label
   Improvement Program,
b) Provide Regions with copies of each LIP Notice,
c) Provide list of registrants affected by a Notice,
   status of the products affected and date of accep-
   tance of final  printed labeling for each product
   i n compli ance.

Regional Responsibility	
a) Provide copies  of all pertinent materials to the States.
b) Provide guidance  and assistance for State enforcement
   efforts.
c) Assist in issuance  of SSURO's.

State Responsi bi 1 i t.y	
a) Schedule and conduct inspections of affected registrants.
b) Issue SSURO's to  non-complying registrants.
c) Take enforcement  actions where appropriate.

-------

MEMORANDUM
              UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                          WASHINGTON, D.C. 20460
                              SEP 3  1985
                                                            OFFICE OF
                                                    PESTICIDES AND TOXIC SUBSTANCES
SUBJECT:  Compliance Strategy for FIFRA 3(c)(2)(B)
          Suspensions
FROM:     A. E. Conroy II, Director
          Office of Compliance Monitoring

TO:       Addressees
     Attached is the Compliance Strategy for FIFRA Section
3(c)(2)(B) Suspensions.  This strategy sets forth the
responsibilities of the Office of Pesticide Programs (OPP),
OCM and the Regions in implementing a program to assure com-
pliance with suspensions issued under section 3(c)(2)(B) of
FIFRA.

     Section 3(c)(2)(B) of FIFRA authorizes the Administrator
to require registrants to develop and submit data to fill gaps
in the data base for registered pesticides.  Failure to respond
to a section 3(c)(2)(B) data call-in or to properly develop
data results in suspension of the product for which the data
was requested.

     Comments on the draft compliance strategy and OCM's
responses are as follows:

     0 One Region requested that the three month period for
       conducting inspections for compliance with the Stop
       Sale, Use or Removal Order (SSURO) not begin until the
       States receive the information on the issuance of the
       SSURO.  The strategy has been amended to reflect this
       comment.

     0 One Region noted that each time a State is requested to
       conduct a Section 3(c)(2)(B) inspection, the grant will
       have to be renegotiated and outputs will have to be
       adjusted.  An amendment to the FIFRA Enforcement Grant
       Guidance was issued on July 31, 1985 to address this
       problem.

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                              -2-
     0  Several  Regions questioned the need to search FATES to
       provide a list of inspection targets to the States.
       The list provided by OCM lists only the registrants
       affected.  The FATES data will provide the States with
       any establishments that may have produced the suspended
       products.

     0  One Region commented on the fact that the policy does not
       address contract manufacturers or supplemental  registrants
       who may have produced suspended products.  By the Regions
       providing States with information from FATES on those
       establishments which have in the past produced  suspended
       products, the States should be able to reach those distrib-
       utors who have produced a product which has been suspended
       In the case of contract manufacturing, the registrant
       should immediately instruct the contract manufacturer to
       cease production.  The SSURO sent to registrants covers
       those products produced under contract as well  as pro-
       ducts supplementally registered.  States can confirm
       that distribution has been halted by visiting those
       establi shments.

     0  One Region commented that the Regional offices  needed the
       certified receipt cards for the NOITS and SSURO to support
       enforcement cases.  OCM will not routinely send the certi-
       fied receipt cards to the Regions.  Please note that OCM
       may have one green card, verifying that the registrant
       received the SSURO, which applies to several establish-
       ments located in different Regions.  If a Region needs
       a certified receipt to support a specific enforcement
       action, OCM will provide it on request.

     0  The Office of Pesticide Programs suggested that OCM in-
       clude a copy of the OPP Standard Operating Procedure
       Number 3049.1 - Suspension of Pesticide Registrations in
       the package.  OCM has attached the SOP to this package.

     Thank you for your cooperation in reviewing the draft
strategy.  If you or your staff have questions, please contact
David Stangel of my staff at FTS 382-7845.

Attachments

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                                                        SEP  3665
        COMPLIANCE STRATEGY FOR FIFRA 3(c)(2)(B) SUSPENSIONS


OVERVIEW

     Section 3(c)(2)(B) of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) authorizes the Administrator to
require registrants to develop and submit data to fill  in gaps
in the data base for registered pesticides.  Failure to respond
to a FIFRA 3(c)(2)(B) data call-in appropriately or failure to
develop data as agreed to in the FIFRA 3(c)(2)(B)  response will
result in suspension of the product for which the data  was
requested.  In those cases the Office of Pesticide Programs
(OPP) will issue a Notice of Intent to Suspend (NOITS).  The
suspension becomes effective thirty days after its receipt unless
the company complies with the requirements of the data  call-in
notice, requests a hearing, or requests a voluntary cancellation.
Generally, there will  be no existing stocks provisions  for products
in the registrant's possession unless registrants request a
voluntary cancellation.

     In order to enforce a suspension under FIFRA 3(c)(2)(B),
it is necessary to issue a Stop Sale, Use, or Removal  Order
(SSURO) and to conduct followup inspections.  A registrant whose
product is suspended under FIFRA 3(c)(2)(B) may comply with the
data call-in requirements at any time.  OPP will lift  the suspen-
sion and OCM the SSURO provided all FIFRA 3(c)(2)(B)  data
requirements have been met for that product.


REGULATED INDUSTRY

     The regulated industry consists of all registrants which
receive a FIFRA 3(c)(2)(B) data call-in notice.  There are
several types of data gaps for which data call-in notices may be
i ssued :

     0  chronic toxicological data gaps,
     0  registration standards data gaps,
     0  special review data gaps, and
     0  others such as product chemistry data gaps, confidential
        statements of formula, or ground water data gaps.


REQUIREMENTS                                                      ~

     Section 3(c)(2)(B) of FIFRA:

     0  Authorizes the Administrator to require additional data
        on a chemical  to further evaluate the chemical  and to
        support existing registrations.

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o
                                -2-

        Requires each registrant to provide evidence  within
        ninety days after notification that he is  taking  appro-
        priate steps to secure the additional  data.

        Grants EPA the authority to issue a Notice of Intent
        to Suspend if a registrant fails to take steps  to secure
        the required data. (This includes failing  to  respond  to
        the data call-in notice, responding inadequately  such as
        maintaining that testing is not necessary, or failing
        to submit data in the timeframe to which the  registrant
        committed or which OPP established.)

        Allows a registrant and other parties  adversely affected  by
        the NOTTS to request a hearing within  thirty  days of
        receipt of the NOTTS by the registrant regarding  whether:
        (1)  the registrant diligently took one of the  listed
        steps to develop the data, or whether  (2)  the Agency's
        decision on the disposition of existing stocks  is consistent
        with the Act.  If a registrant requests a  hearing, the
        suspension on his product does not take effect  until
        after the conclusion of the hearing.

        Each registrant originally is given the following options
     for complying with the data request:

     0  develop or supply the required data himself or  jointly
        with other registrants;

     0  certify that the product is exempt, e.g.,  because it  is  an
        end-use product formulated from a registered, non-suspended
        manufacturing use product and was therefore not subject
        to the data call-in for safety data;

     0  delete uses that require the data requested;

     0  request and receive a waiver of some or all  of  the data
        requi rements; or

     0  voluntarily request cancellation.

     Failure to exercise one of these options  within  certain
specified time periods will result in the suspension  of the
registrant's product.  When a product is suspended under FIFRA
3(c)(2)(B), there will generally be no existing stocks provisions
for products in the registrant's possession.  More information
on how OPP suspends a product and the conditions of the suspension
can be found in OPP's Standard Operating Procedure for  FIFRA
3(c)(2)(B) Suspensions.

ENFORCEMENT OBJECTIVES                                           ~

     The aim of the compliance strategy is to  enforce the F
3(c)(2)(B) suspension via a SSURO.

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                                -3-
TYPES OF VIOLATIONS
     Section 12(a)(2)(J)  of the Act prohibits the violation  of a
suspension order under FIFRA 6.  There is, however,  no specific
unlawful  act under section 12 for the violation of a  section
3(c)(2)(B) suspension order.  Under section 13 of FIFRA, the
Administrator may issue a SSURO when a product is suspended.  By
issuing a SSURO, EPA is able to enforce the suspension.  Any person
violating a SSURO would be in violation of section 12(a)(2)(I) and
would be subject to the penalties thereunder.  It is  essential that
each registrant of a suspended product be issued a SSURO in  order
for the section 3(c)(2)(B) suspension to have the force of law.


NEUTRAL ADMINISTRATIVE INSPECTION SCHEME

     The Regions should work with the States to schedule inspec-
tions of producing establishments of suspended products within
three months after the State receives notification of the SSURO.
Once it is determined that a producing establishment  is in compli-
ance, no additional special targetting is necessary.   However,
continued compliance should be checked during the next routine
i nspecti on.

ADMINISTRATIVE CONSIDERATIONS                                    ~

Program Management	

     OPP is responsible for tracking data requests up until  the
point at which a commitment to test is made.  At that point,
the Office of Compliance Monitoring (OCM) is responsible for
tracking the test schedule.  OPP is responsible for issuing
the NOITS and tracking the registrants' responses.  When a pro-
duct is suspended (thirty days after receipt of the NOITS unless
the registrant requests a hearing or complies with the data
request), OPP notifies OCM and forwards a copy of the NOITS  to
OCM.  At that time, OCM will issue a SSURO to the registrant of
the suspended product.  Previously, OPP had allowed a specified
amount of time for continued production of the product and sale
of all existing stocks.  The current OPP Standard Operating
Procedure indicates that there will be no distribution of stocks
by the registrant allowed after the effective date of the suspen-
sion, i.e., thirty days after receipt by the registrant.  If
there are any existing stocks provisions allowed, OPP will forward
this information to OCM at the same time OPP notifies OCM of the
effective suspension.  Normally, there will be no prohibition on
sale of suspended products in the channels of trade.

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                              -4-
     At the time that OCM issues the SSURO,  it  will  send  a  sample
copy of the SSURO, a sample NOITS, a list of registrants  to whom
SSURO's were issued and products affected, and  any  other  relevant
supporting documents to the Regions.  The Regions  will  notify
States of the suspension and the SSURO and provide  them with
copies of all the information which the Region  has  received from
OCM.  The SSURO may only be vacated by OCM.   This  will  only be
done when OPP is lifting the suspension because the  company has
come into compliance with the data call-in request.   The  Regions
will be notified immediately that OPP has lifted the suspension
and OCM has vacated the SSURO.  Regions and  States  may  issue
SSURO's for any products which have been distributed in violation
of a SSURO issued by OCM.

ALLOCATION OF RESPONSIBILITIES	

OPP
Issues data call-in notices and tracks responses.

Issues NOITS as appropriate and tracks responses.

Notifies OCM of products suspended and provides copies  of
NOITS at that time along with other relevant documents.

Lifts suspensions when registrant fully complies.

Prepares letters lifting the suspensions and the SSURO's  for
OPP and OCM signature.

OCM
Tracks testing once commitment to test is made and notifies
OPP of failures by registrants to meet commitments.

Issues a SSURO to the registrant after being notified that
a suspension is effective.

Sends the Regions a list of registration numbers for suspended
products and the names and addresses of registrants which
received SSURO's within 5 days of mailing the SSURO's.  OCM
will also send a sample SSURO and NOITS.  Upon request by a
Region, OCM will provide the actual SSURO and NOITS for a
specific product as well as the certified receipt.

Vacates a SSURO at the same time OPP lifts the suspension for a
registrant, which fully complies with the data call-in, and sends
the Region information on the vacation of the SSURO.

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                             -5-
 s working with OPP to develop and implement a system for tracking
 ;uspensions and SSURO's.

 legions	
legions forward information on the suspensions and SSURO's to
:he States within a week of receipt and work with the States
in monitoring compliance.  The Regions will  provide to the
States a list of producing establishments which have produced
the products subject to the suspension and SSURO.  This informa-
tion should be obtained from FATES.

In those States without State Cooperative Enforcement Agreements,
the Regions monitor compliance with the SSURO's within three
months of their receipt of the information on the issuance of
the SSURO.

Regions negotiate with the States to assure  that States conduct
inspections at producing establishments to verify compliance
within three months of the date the State receives the information
on the SSURO and that States check for compliance during
future routine producing establishment inspections.

Regions will handle any cases arising from violations of the
SSURO's issued by OCM.

States
States will conduct follow-up inspections to ensure compliance
with the SSURO's and forward results of the inspections to the
Regions.  For situations involving a violation of the SSURO, the
State will  forward the case file to the Region for appropriate
enforcement action.

PENALTIES

     Violation of a SSURO is a violation under section 12(a)(2)(I)
and subject to the penalties found under section 14(a)(l) and
section 14(b)(l).  Violation of a SSURO will generally result in
an administrative civil complaint.  The FIFRA penalty policy
provides guidance on calculating the administrative civil
penalty for this violation.  Repeated or continued violations of
SSURO's will  be considered for criminal referral.

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            UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                        WASHINGTON, D.C. 20-160
                                                          OFFICE OF
                                                  PESTICIDES AND TOXIC SUBSTANCl
MEMORANDUM
SUBJECT:  Compliance Monitoring Strategy for Pesticide
          Registration Cancellations Due to Nonpayment of  Fees

FROM:     John J. Neylan III, Director
          Policy and Grants Division
          Office of Compliance Monitoring

TO:       Addressees


     Attached is: (1) the Compliance Strategy  for Pesticide
Registration Cancellations Due to Nonpayment of Fees; and  (2) the
Notice of Cancellation which was published in  the Federal
Register on October 18, 1989  (54 FR 42936).  Thank you for your
comments on the February 12, 1990 draft.  A summary of those
comments and our responses is also attached.

     The effective date of cancellation for the first fee  period
was October 10, 1989, the date of the letter informing
registrants of the Cancellation Order.  However, registrants
could continue to sell and distribute existing stocks until  March
1, 1990.  The attached Strategy calls for routine producer
establishment inspections to ensure that the 20,000 pesticide
products are not sold in violation of FIFRA.   Last October,  the
Office of Pesticide Programs  (OPP) sent the States and Regions
copies of the list of approximately 20,000 products, which were
cancelled for nonpayment of fees under FIFRA section 3 and
section 24(c).  On March 9, 1990, the Office of Compliance
Monitoring (OCM) sent the Regions a list of the registrants  and
producing establishments, which have produced  since 1984 any of
the pesticide products cancelled for nonpayment of fees.

     Please provide copies to the State pesticide control
officials in your Region as soon as possible.  If you have any
questions regarding the Strategy, please contact Beverly Updike
Of my Staff at FTS 475-9438 (EN-342).


Attachments
                                                            Pr.mad on Recyd:-J Pa^g?

-------
                  ADDRESSEES
           I    Louis F. Gitto, Director
                Air, Pest. & Toxics Mangt. Div.

           II   Barbara Metzger, Director
                Environmental Services Div.

           Ill  Thomas J. Mas1any, Director
                Air, Toxics and Radiation Mangt. Div.

           IV   Winston A. Smith, Director
                Air, Pest. & Toxics Mangt. Div.

           V    William H. Sanders III, Director
                Environmental Services Div.

           VI   Bob Hanneschlager, Acting Director
                Air, Pesticides & Toxic Div.

           VII  William A. Spratlin. Director
                Air and Toxics Div.

           VIII Irwin L. Dickstein, Director
                Air and Toxics Div.

           IX   David P. Howekamp, Director
                Air Management Div.

           X    Lynn McKee, Acting Director
                Air and Toxics Div.
cc:  Valerie Jewett  (TS-788)

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                               ADDRESSEES
                             (TS-766C)
                             (TS-767C)
                             (TS-767C)
                             (H-7506C)
                             (LE-134P)
                             (LE-132A)
                             (EN-342)
                                it
     Douglas D. Campt
     Edwin F. Tinsworth
     Anne Lindsay
     Steve Johnson
     Michael Walker
     Mark Greenwood
     A. E. Conroy II
     Connie Musgrove
     David Dull
     Mike Wood
     Phyllis Flaherty
     Jerry Stubbs
     Maureen Lydon
     Ken Kanagalingam
     Bob Zisa
     Sherry Sterling
     Jan Bearden
     Jake Mackenzie
     Western Regional Compliance Director
II
     Marvin Rosenstein. Chief
     Air, Pest. & Toxics Mangt. Div.
     Pest. & Toxic Substances Br.

     Ernest Regna, Chief
     Environmental Services Div.
     Pest. & Toxic Substances Br.
Ill  Larry Miller, Chief
     Hazardous Waste Managt. Div.
     Toxic & Pest. Br.

IV   Richard D. Stonebraker, Chief
     Air, Pest. & Toxics Mangt. Di.
     Pest. & Toxic Substances Br.

V    Phyllis Reed, Chief
     Environmental Services Div.
     Pest. & Toxic Substances Br.
VI   Robert Murphy, Chief
     Air, Pest. & Toxic Div.
     Pest. & Toxic Substances Br.

VII  Leo Alderman, Chief
     Air and Toxics Div.
     Pest. & Toxic Substances Br.

VII  Martha Nicodemus, Act. Chief
     Air and Toxics Div.
     Toxic Substances Br.

IX   Davis Bernstein, Chief
     Air Management Div.
     Pest. & Toxics Br.

X    Kenneth Feigner, chief
     Air and Toxics Div.
     Pest. & Toxic Substances Br.

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    RESPONSE TO COMMENTS ON PESTICIDE CANCELLATION STRATEGY


     All of the  following comments submitted by the Regions are
 appreciated and  have been considered.  The Compliance Strategy
 incorporates many of these comments.
                      /
 Existing Stocks

 COMMENT 1

 One commenter wanted the following language used in the Strategy
 to  be added to the Summary:

     Due to the  face that the Cancellation Order allows stocks at
     the dealer  and user level to be used until exhausted,
     inspections beyond those at producing establishments are not
     being requested.

 RESPONSE 1

 We  have incorporated that statement into the Summary.
COMMENT 2

A commenter reported that the proposed existing stocks provision
presents a problem for those States in which pesticide products
must have a current EPA registration to be offered for sale.

RESPONSE 2

State inspectors should take their direction from the State laws
in those States which have more stringent laws regarding the
distribution and sale of existing stocks of pesticide products no
longer registered by the EPA.
Enforcement Response

COMMENT 3

One commenter asked what would be the appropriate enforcement
action if the inspectors discovered pesticides on the
cancellation list in the marketplace.

RESPONSE 3

If an inspector finds existing stocks at the user and dealer
level which have been produced, packaged or labeled after October
10, 1989 (effective date of cancellation), those stocks are in
violation of the Cancellation Order. Registrants had until March
1, 1990, to dispose of existing stocks of cancelled products.  A
Stop Sale, Use or Removal Order (SSURO) should be issued for
violative acts and penalties assessed as needed.

-------
Cancellation Information

COMMENT 4

One conmenter requested that the list of registrants and producer
establishments which produced since 1984 any of those pesticide
products included among the 20,000 cancellations be sorted by
registrants with product names.

RESPONSE 4

The information was developed in this format and mailed out by
OCM.
COMMENT 5

One commenter cited a need for a list of current cancellations
and SSUROs.

RESPONSE 5

This Strategy deals only with the cancellations related to
nonpayment of the registration maintenance fees.  OCM will send
out periodic updates amending the list of products cancelled for
nonpayment of the fees.  In addition, in April, the Compliance
Division of OCM published a booklet, "Suspended, Cancelled, and
Restricted Pesticides", which summarizes the Agency's actions on
such pesticides.

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                        SUMMARY
      COMPLIANCE MONITORING STRATEGY FOR PESTICIDE
  REGISTRATION CANCELLATIONS DUB TO NONPAYMENT OF FEES
The due date for-the EPA required payment of the maintenance
fee to maintain registration was March 1, 1989.

On October 10, 1989, EPA notified registrants of 20,000
products by letter that their registrations were being
cancelled due to nonpayment of maintenance fees.  A Notice
of Cancellation was published in the Federal Register on
October 18, 1989.  The effective date of cancellation was
October 10, 1989, the date of the letter informing
registrants of the Cancellation Order.

Registrants could continue to sell and distribute existing
stocks until March 1, 1990.  Existing stocks are defined as
those stocks produced, packaged and labeled on or before the
effective date of cancellation.

Compliance inspections to assure compliance with these
cancellations will be conducted by States and EPA (where
there is no Cooperative Enforcement Agreement) as part of
their routine pesticide producing establishment inspections.
Due to the fact that the cancellation order allows stocks at
the dealer and user level to be used until they are
exhausted, inspections beyond those at producing
establishments are not needed.

All imports are to be checked against the cancellation list
prior to Regions signing off on the Notice of Arrival.

Exports are subject to FIFRA section 17(a) after
October 10, 1989 and should be checked as part of routine
inspections.

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                COMPLIANCE STRATEGY FOR PESTICIDE
      REGISTRATION CANCELLATIONS DUE TO NONPAYMENT OF FEES
OVERVIEW	;	

     Section 4(1)(5) of the Federal Insecticide, Fungicide and
Rodenticide Act  (FIFRA) requires the payment of annual pesticide
registration maintenance fees by March 1 of each year to keep
registrations in  effect.  During the first fee collection period
ending March 1,  1989, there were approximately 20,000 registered
products for which registrants did not pay the required fee.
Section 4(i)(5)(D) of FIFRA states that the Administrator may
cancel the unpaid registrations without a hearing.  Accordingly,
Cancellation Orders were issued to cancel the majority of the
unpaid registrations.  This group includes approximately 13,500
products registered under section 3 of FIFRA and about 6,000
under section 24(c) of FIFRA.  The Notice of Cancellation was
published in the  Federal Register on October 18, 1989 (54 FR
42936).  However, the effective date of cancellation was October
10, 1989, the date of the cancellation letter.  As new
cancellations go  into effect for subsequent fee periods, OCM will
provide an amendment to Appendix II which will inform the Regions
of the products cancelled, the date of the cancellation, and any
existing stock provisions.

     The Federal  Register Notice of October 18, 1989, deferred
for 30 days the cancellations of 189 pesticide products
(containing 77 different active ingredients) for which the
registration maintenance fee was not paid.  These were products
which have been in production at least one year since 1984.
Additionally, unlike the majority of the other cancelled
registrations, the records for these 189 products show that there
are no other registered products containing these active
ingredients. The  deferral period allowed potentially affected
users of these pesticides an opportunity to develop strategies to
maintain the continued registration of any products important to
their needs.  Only four of the registrants producing the 189
pesticide products have now complied with the provisions of the
maintenance fee requirements.  See Appendix I for the list of
product registration numbers and names of the registrants.

     This Compliance Monitoring Strategy provides for compliance
checks during routine producer establishment inspections to
assure compliance with the Cancellation Orders issued for
nonpayment of maintenance fees and to assure compliance with
FIFRA section 17  export requirements.   Note that registrants of
cancelled products for the first fee period could continue to
sell and distribute existing stocks until March 1, 1990.  Due to
the fact that the Cancellation Order allows stocks at the dealer
and user level to be used until they are exhausted, inspections

-------
beyond those at producing establishments are not needed.  As the
Strategy is amended for future cancellations. Appendix II will be
updated to include Federal Register information on existing
stocks, dates of effective cancellation, etc.
REQUIREMENTS
     The Cancellation Order of October 18, 1989, allowed
registrants to continue to sell and distribute existing stocks of
the cancelled products until March 1, 1990, the due date for the
next annual registration fee.  Existing stocks are defined as
those stocks produced, packaged, and labeled on or before the
effective date of cancellation.  Existing stocks already in the
hands of dealers or users can be sold and used until they are
exhausted.  The exceptions to these provisions are cases where
more stringent restrictions on sale, distribution, or use of the
products have already been imposed through separate Agency
actions.  Dates regarding existing stocks provisions for products
cancelled after subsequent fee periods can be found in
Appendix II.                                                             ?
                                                                         c
Exports	        R

     In the case of exports, any products exported after the             r
effective date of cancellation must comply with section 17 of            
FIFRA, which includes citations for other applicable FIFRA               I
requirements. Under section 17, prior to export, a foreign               
purchaser must sign a purchaser acknowledgement statement and a          ^
copy of that statement must be submitted by the exporter to EPA.         
In addition, note that unregistered pesticides intended for              ^
export must conform with labeling requirements pursuant to               
section 17, including section 2(q)(l)(H)  (i.e., the label must           5^
say in a conspicuous manner "Not Registered for Use in the United        
States of America").                                                     ^
                                                                         K

COMPLIANCE MONITORING                                                    
                                                                         i
                                                                         C
                                                                         H-
                                                                         CO
     Compliance inspections are to be conducted by the States and        *"
EPA (in States without Cooperative Enforcement Agreements) during        ?f
routine producer establishment inspections to monitor compliance         P
with the cancellations and the section 17 export provisions for          %
such products.  If inspectors find cancelled products at the             
producing establishment after March 1, 1990, Stop Sale, Use or           
Removal Orders  (SSUROs) should be issued.  Prior to establishment        $
inspections, States should check the list of producing
establishments to determine if an establishment has produced one
or more of the products since 1984.  Appropriate enforcement is
also to be taken for violative products.

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ALLOCATION OF RESPONSIBILITIES
     The following is a summary of the allocation of
responsibilities between OPP, OCX, Regions and the States.

Office of Pesticide Programs (OPP)	

Will provide the Regions and States with a hard copy and disks of
the list of products and registrants cancelled because of
nonpayment of maintenance fees for section 3 and section 24(c)
registrations.

Will provide periodic updates of deletions or additions to the
cancellation list will be provided to OCM.

Office of Compliance Monitoring (OCM)	

Will provide the Regions with a list of registrants and producer
establishments which have recently produced (since 1984) any of
those pesticide products included among the approximately 20,000
cancelled for nonpayment of maintenance fees.

Will prepare the Compliance Monitoring Strategy for Pesticide
Cancellations Due to Nonpayment of Maintenance Fees and will send
periodic updates of additional cancellations or deletions to the
cancellation lists.

As new cancellations go into effect for other maintenance fee
periods, OCM will update the Compliance Strategy to include
information on the number and type of product cancellations.
Appendix II will be updated to include Federal Register
information on existing stocks, dates of effective cancellations,
etc*

Regions	
T  "

Will provide the States with the Strategy.

Will conduct compliance inspections as part of routine producer
establishment inspections in States without Cooperative
Enforcement Agreements to assure compliance with the October 18,
1989 Cancellation Order and section 17 export requirements.

Will distribute the list of cancelled products; the names of
registrants whose products have been cancelled; and information
on producing establishments to the States, including updates on
newly cancelled products or products whose cancellations have
been rescinded.

Will check all Notices of Arrival for imports against the list of
cancelled products before releasing such products.

Will take enforcement action and issue Stop Sale, Use or Removal
Orders (SSUROs), as appropriate.

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States	

Will conduct compliance inspections as part of routine
establishment inspections to assure compliance with the October
10, 1989 Cancellation Order and export requirements.

Will take enforcement action and issue Stop Sale, Use or Removal
Orders (SSUROs), as appropriate.

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                            APPENDIX Z
The following registrants for the pesticide products listed
below, which were previously included among the 189 deferred
products, are now in compliance with the 1989 maintenance  fee
requirements of FIFRA.
Reg.No.
Registrant &
Product No.
Product Name
#47319
#11275
Savanah Co.
047319-00001
047319-00002
047319-00004

Guth Corp.
011275-00002
                           Sevana Bird Repellent
                           Sevana Bird Repellent
                           Agrigard Insect Repellent
                           Lithate 2,4 D - Broadleaf Weed Killer
                           Non-Volatile
#01457    Hexcel Corp.
          001457-00015

#08730    Hercon Environ-
          mental Co.
          008730=00035
                 Bromat
                 Lure N Kill Roach and Ant Killer
                 Insecticidal Baits With Sex Lure
                                                              CO
                                                                        Ul
                                                                         U>
                                                                         CO
                                                                         I
                                                                         OJ
                                                                         NJ

                                                                        I"
                                                                         U1
                                                                         S-

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                                                APPENDIX II

                                       SUMMARY OF CANCELLATIONS
FEDERAL
REGISTER
NOTICE
MAINTENANCE
FEE PERIOD,
MARCH 1
NUMBER OF
PRODUCTS
CANCELLED
EFFECTIVE
DATE OF
CANCELLATION
EXISTING STOCKS AT
REGISTRANT, DEALER 6
USER LEVEL
10-18-89
  J-89
                 13,500 sec. 3
                  6,000 sec. 24(c)
                      10-10-89
                  Registrant can continue to sell and
                  distribute stocks until 3-1-90. Dealer
                  and user can use existing stocks until
                  exhausted.  Existing stocks are defined
                  as those products produced, packaged or
                  labeled by 10-10-89.

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                                    APR 30 1990
                                             **      T   : ; -. i ..  ~j ~ : *.'.'.

MEMORANDUM

SUBJECT:  Strategy for Aldicarb                                  -+*?

FROM:     John J. Neylan ill. Director Sfy^&At^//?//fy/"1
          Policy and Grants Division              '
          Office of Compliance Monitoring (EN-342)

TO:       Addressees

     Attached is the Compliance Monitoring Strategy for the
Voluntary Action by Rhone-Poulenc for Aldicarb.

     On April 11, 1990 Rhone-Poulenc announced that it would
voluntarily stop sale aldicarb labeled for potato use and recall
stocks of aldicarb in areas where potatoes are grown, for
modification of the labels.  In addition the Environmental
Protection Agency, Food and Drug Administration and the U.S.
Department of Agriculture also issued a statement on this action.
This.is a voluntary action by the company while further studies
are completed.  Rhone-Poulenc has not amended its registration to
delete use on potatoes, and they have not voluntarily cancelled
the use.

     No specific inspections need to be targeted as a result of
the voluntary action by Rhone-Poulenc.  In keeping with the
voluntary stop sale by Rhone-Poulenc for these pesticides,  the
attached strategy calls for Regions and states to notify
distributors/dealers/retailers of the action if aldicarb stocks
are found during routine inspections and to monitor compliance
with the revised label as part of any routine or for-cause
inspections.

     Please transmit the strategy to the States within your
Region.  If you have any questions on the attached aldicarb
strategy, please contact Virginia Lathrop at FTS 475-8418.

Attachments

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Addresses:

Douglas  Campt   (TS-766C)
Edwin F. Tinsworth   (TS-767C)
Anne Lindsay   (TS-767C)
Fredrick Stiel  (LE-134A)
Mark Greenwood  (LE-132A)
A.E. Conroy II  (EN-342)
Connie Musgrove   "
David Dull   "
Mike Wood  "
Jerry Stubbs    "
Maureen  Lydon    "
Ken Kanagalingam   "
Bob Zisa  "
Sherry Sterling   "
Jan Bearden   "
Michael  Walker   (LE-134P)
Valerie  Jewitt   (TS-788)
John Tice   (TS-769C)
Artie .Williams  (H-7508C)
Phil Ross  (LE-132A)
REGIONS, DIVISIONS:

Jake Mackenzie
Western Regional Coordinator

Louis Gitto, Director
Air Management Division, Region I

Barbara Metzger, Director
Environmental Services Division, Region II

Thomas J. Maslany, Director
Air, Toxics and Radiation Management Division
Region III

Winston A. Smith, Director
Air, Pesticides & Toxics Management Division
Region IV
&
William H. Sanders III, Director
Environmental Sciences Division, Region V

Bob Hanneschlager, Acting Director
Air, Pesticides and Toxics Division, Region VI

William A. Spratlin, Director
Air and Toxics Division, Region VII

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Irwin L Diskstein, Director
Air and Toxics Division, Region VIII

David P. Howekamp, Director
Air and Toxics Division, Region IX

Gary O'Neal, Director
Air and Toxics Division, Region X

BRANCH CHIEFS:

Marvin Rosenstein, Chief
Pesticides & Toxic Substances Branch
Region I

Ernest Regna, Chief
Pesticides & Toxic Substances Branch
Region II

Larry Miller, Chief
Toxic & Pesticides Branch
Region III

Richard Stonebraker, Chief
Pesticides & Toxic Substances Branch
Region IV

Phyllis Reed, Chief
Pesticides & Toxic Substances Branch
Region V

Robert Murphy, Chief
Pesticides & Toxic Substances Branch
Region VI

Leo Alderman, Chief
Pesticides & Toxic Substances Branch
Region VII

Alvin Yorke, Chief
Toxic Substances Branch
Region VIII

Davis Bernstein, Chief
Pesticides & Toxic Substances Branch
Region IX

Kenneth Feigner, Chief
Pesticides & Toxic Substances Branch
Region X

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                                                Attachment


         ALDICARB COMPLIANCE MONITORING STRATEGY



BACKGROUND
     On Wednesday, April 11, 1990, Rhone-Poulenc announced that
it would voluntarily stop the sale of aldicarb for potato use and
recall the stocks of aldicarb labeled for use on potatoes in
areas where potatoes are grown.  The recalled stocks will be
relabeled to delete the potato use.  This is a voluntary action
by the company while further studies are completed.  Rhone-
Poulenc has not amended its registration to delete use on
potatoes nor has the Company voluntarily cancelled the use.

COMPLIANCE ACTIVITIES    '

     Given that this is a voluntary action by the registrant,
sale, distribution and use of Rhone-Poulenc aldicarb for use on
potatoes remains legal.  However, once a user has a product with
the potato use deleted, he may not use the product for potatoes.

     Although no inspections are being specifically targeted,
routine or for-cause pesticide inspections may involve aldicarb.
During these inspections, two actions should be taken:

    o  When aldicarb products are found at the distributor/
       retailer/user level in States where potatoes are grown,
       the inspector should inform the distributer/retailer/
       user of the voluntary stop sale and recommend that the
       person Contact Rhone-Poulenc at 1-800-334-9745.  It may be
       useful to provide copies of the attached statement when
       aldicarb stocks are found (See Attachment).

    o  If a user applies aldicarb bearing a label which no longer
       has potatoes on it, appropriate enforcement action should
       be taken for use inconsistent with the label.

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                              - 2 -
AFFECTED PRODUCTS
Aldicarb products with potato use on label:
EPA Registration No.     Brand Name
264-319                  Temik Brand TSX Granular Aldicarb
                           Pesticide (1)
264-417                  Temik Brand 15G Aldicarb Pesticide  (2)
264-331                  Temik Brand 10% Granular Aldicarb
                           Pesticide (3)
    (1) This is the most  common aldicarb product sold  in  1986  to
        1988.
    (2) Sold primarily  in 1988.
    (3) Only sold  for export  in 1987.

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                 Environmental  News
                               .
                       (TIIUnCDAY,  APRIL 11,  1990)
     The following  joint statement is being  issued as the result of
action taken yesterday by Rhone-Poulenc Ag Co. to voluntarily stop sales
and recall the stocks of the pesticide aldicarb  for use on potatoes.  The
Company has informed EPA that it found the allowable residue level of
aldicarb was exceeded on a few potatoes in one field among 26 fields
tested.  Aldicarb has been registered since  1970 to control insects,
mites and nematodes.  Since aldicarb was registered, there have been  no
reported illnesses  from eating potatoes.  For more information, contact
Al Heier at (202) 382-4374.

                           JOINT SATEMENT BY

                    ENVIRONMENTAL PROTECTION AGENCY

                      FOOD AND  DRUG ADMINISTRATION
                                  AND
                     U.S.  DEPARTMENT OF AGRICULTURE

     The Environmental Protection Agency (EPA),  the Food and Drug
Administration (FDA) and the U.S. Department of  Agriculture (USDA)
commend Rhone-Poulenc Ag Company for voluntarily ceasing the sale and
recalling the stocks of the pesticide aldicarb for use on potatoes due to
recent data which indicate that the allowable residue level was exceeded
on potatoes in isolated cases.  The action taken yesterday is a cautious
measure to ensure the safety of our food supply.

     Consumers should not be alarmed and they should continue their
normal consumption  of potatoes.   The company is  taking this action after
recently finding that the allowable residue  level was exceeded in ten
individual potatoes among approximately three hundred that were tested
following a request for data from the EPA.

     In the seventeen years aldicarb has been used, there are no reports
of illness from eating aldicarb-treated potatoes.  At the highest levels
found in a few potatoes, aldicarb could cause flu-like symptoms such  as
nausea,  headache and blurred vision which disappear quickly.

     EPA will continue to review and nonitor this situation and t.ike
further action if necessary.

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x.// i"    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
- '**
,,,. >y                     WASHINGTON. D.C.  2CM60

                                           JAM  1 Q 1975
To:       Regional !Ulministrators

                          istrator" iorw
From:    AssTj^aninTnistrator" iorwater
          and Hazardous. Materials (WH-556)
         Assistant Administrator for Enforcement,^
         and General Counsel (EG-329)          U
Subject:  Continuing Slate Registration of Products  Containing
         Alclrin and Dieldrin for Which Uses Have Been Suspended

    Late inDeccmbar, 1974, the Agency became aware of the existence of
activity in the above referenced  matter, first in the State of California,
and subsequently in several other States in other Regions0  Preliminary
investigation  into the magnitude  of the problem suggests that there may
bo significant continuing activity on a national scale,  that there is con-
fusion as to the ex tent of Federal jurisdiction over  such activity by States,
and that the  economic,  political  and regulatory considerations involved
require ad rational action by the Agency,

    Accordingly, our joint stuffs  are preparing a Federal Register notice,
v/hlch,  upon  publication, v/ill formally assort Fed~3".i~a.f~jurisciiction over
nop.-Fooe rally registered  products containing A^rin and  Dieldrin by
implLT/.cnting Section 3. of the Federal InseoTicirie, Funj^ctd'-e  and
Rcder.tLcide Act (F1FRA), as amended (7 U.S. C.  136 et seo.). Attached
is a strategy pap^r  v/hica explains the background of this matter in greater
detail and  provides an explanation of how those Ald.-in and Dieldrin pro-
ducts should be  treated upon the  activation of Section 3.  In add-.tion,
proposed enforcement activities b}- the Agency, anticipated in cooperation
with involved States, is discussed,,

    We  shall expedite publication of this notice in the Federal Register.
Pending formal  publication, you should proceed  v/ith confidence in t!ie
proposed substance of  the  notice as outlined above and in the attached
paper to inform affected States  in your Region of  these developmer'-s,
Further, \vetrustyou \vill encourage their support and cooperation in our
effort to achieve orderly and equitable disposition of existing State-reg-
istered products together \vith even-handed  aud coinpreheiisivc enforce-
ment of the  Aldrin-Dieldrin cancellation  and  s*.: sponsion orders.  The
Enforcement Division of each region \vili be contacted by the  Pesticides
Enforcement Division in Washington v/hi.ch \vill provide additional dot ails
and support, v.-hcrc needed, to achieve Federal-State cooperalic-.i in pro-
viding notice of these developments and in proceeding \vit.h  enforcement
of the Administrator's orders relating to cancellation and suspension of
Aldrin  and Dieldrin,,

Enclosure:

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     ;    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

' ,o*0%P                     WASHINGTON. D.C. 20460
  Strategy Paper:

          State Registration of Products Containing Aldrin and'Dieldrin
          for Which Uses Have Been Suspended


  Background;

     Late in  December, 1974 Headquarters was informed by Region  DC
  and the  State  of California  that products containing Aldrin and Dieldrin
  were being.registered by the State in possible contravention of the intent
  of the Administrator's Order of December 7, 1972 (37 F.R. 26463,  26465).
  That  order provided that  henceforth all technical Aldrin and Dieldrin
  must  bear the label  restriction:  "For use only in  formulating prodvicts
  bearing EPA-approved FIFRA registrations." It was thought that such a
  restriction on use of the technical material, which is available only
  through import and therefore subject to Federal jurisdiction,  would pre-
  clude  further formulation of finished  products  for State registration
  and thereby provide ds facto  Federal control of all products containing
  Aldrin or  Dieldrin, Investigations by California  and Region IX (confirmed
  now by several other Regions and State.-;) have revealed that many State-
  rc-ffistaved Alck-Ln-Dieldrin products wore:  1) formulated from  technical
  material held prior to December 7, 1972  and  therefore not subject to the
  restrictive  labeling requirement, 2) formulated from so-called "end-
  use" or finished Aldrin-Diclclrin products bearing State or Federal
  registi-ations and lacking any stated restrictions concerning refor-
  mulation,  3) formulatod from technical meterial sold after December  2,
  1972 which failed to bear the required restriction,  4) formulated from
  technical  material restrict!vely labeled and ignored by the formulator.
  Stales,  having lately become aware, of the intent of the Decemoer,  1972
  order, are faced with a dilemma: pressure to reregister  for continued
  shipment,  sale and use products formerly approved by them  and the
  likelihood  that such registration  contravenes at least the spirit, and- in
  some  cases possibly the letter,  of a Federal  cancellation order,

  Action;

     In order to clarify existing ambiguities concerning the legal status of
  these  non-Federally registered  products  with respect to  Federal ju:-i^ac-
  tion over their production, shipment,  sale, and use, and to insure -jvon-
  handod enforcement of the Aldrin and Dieldrin cancellation and sus;;ti-|Pion
  orders, ihe Agency will formally implement Section 3 of  the Federal Inso.c-
  ticide, Fungicide, and Rodculicide Act, as amcndod (7 U, S. C. 13G ct seq.)
  by notice in the Federal Register.  This notice will contain an  exemption,

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                                -2-

pursuant to the provisions of Sections 6(a)(l) and 15(b)(2) of the Act, allow-
ing States to register fox* orderly disposition through shipment, sale and
use in that  State, existing stocks of products containing Aidrin and
Dieldrin produced on or  before the date of signature by the Administrator
of the order implementing Section 3 of the Act as to these State-registered
products. Effective the day follov/ing signature of the order implementing
Section 3 of the Act,  production of products containing Aldrin and Dieldrin
must cease, and States rmist cease to register for shipment, sale and use
any but existing stocks of such products.

    Regional offices should arrange  to advise appropriate authorities in
States in that Region, in  advance,  of the planned activation of Section 3
and its attendant prohibitions,  and should request State authorities to
noti'y all State registrants and any other potentially affected parties of
the activation  of Section  3 and of the effective date of related prohibitions.
States are to be asked to provide to the appropriate Regional OCficcs lists
of State registrants or persons -.vith registration applications pending for
products containing Aldrin or Dieldrin, Information relating to location
and relative amounts of  these State-registered products also is to be
sought.

    The Agency's pesticides enforcement personnel \vill enlist Slate coope-
ration in  continuing its  on-goiny  investigation of the  formulation since
December  7,  1972,  01" products containing Aldrin or Dieldrin for State
registration.  Should it  be the case that Federal registrants of technical
Ald'rin  orDiclcU'in have not r^ir.belc^ their products in coni'ormance v/ith
the Administrator's  Order of December 7,  1072,  or that posticicJ;- pro-
ducers have formulated  products containing Alcirin or  Dieldrin in con-
travention of labeling prohibitions against use in non-Federally rc'gisrcred
products,  such violations \vill be prosecuted in accordance v/ith the appro-
priate provisions of the  Act.

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      UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                      WASHINGTON, D.C.  20460
To:      [Enforcement Division Directors]

From:   A. E. Conroy II, Director         //  ,*[  (,T
         Pesticides Enforcement Division  /*    "

Subject:  Non -Federally Registered Products Containing Aldrin or Dieldrin


Background;

    In his memorandum of December 10,  1974,  Point #4, the Director
advised that production of non-Fed-arally registered products containing
Aldrin and Dieldrin contravened the December 7, 1972 Order of the
Administrator (37 F.R.  25463, 26465). The intent of  that ord*r was to
restrict use of technical Aldrin and Dieldrin to use in EPA-registered
products only. The Director's memorandum continued that production
of non-Fedcrally registered products containing Aldrin and Dieldrin
could subject  such products  to stop sale and their producers to liability
under Sections 12(a)(2)(G) and (K)  of the Act.

    Subsequent to  the Director's memorandum, it has come to the
Agency's stcention that numerous  products containing Aldrin anu Dieldrin
r-'.a*' have be~n produced since December 7. 1972 and  rpaistproH vy .;roT^ =
under circumstances not strictly  contravening the December,  1972 Order.
Details concerning this production and questions  relating to the scone of
Federal jurisdiction over such production under the December, 1972
Ord**** are elaborated in the  attached memorandum  and strategy paper,
which vere sent to all Regional Administrators on January 10, 1975.

Action;

    For purposes  of I- ederal enforcement activity,  the following develop-
ments are important:

         1) The Agency has determined  to implement Section 3 of the
            Act with respect to products containing Aldrin and Dield: in
            intended for intrastate shipment.  States will be  permitted
            to register  and  allow shipment, sale and use in  that State
            of stocks  of products containing Aldrtn or Dieldrin in  3:
-------
                                -2-

            and States must cease to permit registration or to allow
            shipment, sale or use of any but existing stocks. Viola-
            tions of the Act will be subject to prosecution 60 days
            after Federal Register publication of the Administrator's
            order.  (This of course will not apply to- those products
            registered Federally and by States for uses which have
            not been suspended: 1) subsurface ground insertion for
            termite control; 2) dipping of non-food roots and tops; 3)
            moth-proofing in a closed system.)

         2) It is the obligation of each Region to notify, in advance,
            appropriate State authorities of this development and its
            attendant prohibitions and to enlist their aid in notifying
            registrants and other affected persons in their State.
            Attached is a sample letter which States may wish to
            employ as a  guide in the notification process.

         3) Immediately upon signature, of the Section  3 order. Head-
            quarters staff will notify Regional officials  who should con-
            tact the State authorities directly.

         4) Cooperation and aid of State authorities is to be enlisted in
            obtaining for Federal use:

            -  lists of State registrants or persons with applications
               pending for Aldrin-Dieldrin product registration;
            -  information on location an<^ relative am/Mints or" such
               ducts within the Slate;

            -  assistance of State enforcement authority to achieve com-
               pliance with the production, registration,  and shipment,
               sale and use cut-off.

         5) EPA regional personnel are to continue their investigations
            of production since December 7, 1972 of products contain-
            ing Aldrin and Dieldrin for Siato registration.  Should it be
            determined -;ha*. Federal registrants of technical Aldrin or
            Dieldrin have not relabeled their products in conformance
            with the Administrator's Order of  December 7, 1972,  or
            that pesticide producers have formulated products confin-
            ing Aldrin or Dieldrin in contravention of labeling prohi-
            bitions against use in non-Federally registered products,
            such violations are to be prosecuted in accordance with the
            appropriate provisions of the Act.

    Shorld you have questions or encounter difficulty with regarr, to any
of these matters, please notify the appropriate Regional Coordinator.


Attachments:

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                                         Attachment I

                   Aldrin - Dieldrin Strategy

1.  R.C. 's phone Region in advance of order - inform of "strategy

2.  R.C. 's send Director's enforcement package to Regions

3.  Regions inform States of pending action and request names of
   State registrants

4.  PEP sends Administrator's order to Regions

5.  HDQ sends Administrator's order to States

6.  States or Regions notify State registrants of order
   (See Attachment ii).

7.  Regions follow-up at each State registrant.

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                                      Attachment II SAMPLE LETTER
 State Registrant
 (Address)
 Gentlemen:

     On (date),  the Administrator of the United States Environmental
 Protection Agency issued an Order asserting Federal jurisdiction over
 all  non-Fedcrally registered Aldrin-Dieldrin products in intrastate
 commerce by  invoking Section 3 of the Federal Insecticide Fungicide,
 and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 ct seq. ).
 As  a result of this Order,  the shipment,  sale,  and use of non-Feder-
 ally registered Aldrin-Dieldrin products,  produced after the effective
--d-ate-of-the-Grd-cr-wiit-be-prohibited-- AtrcorxiiTiglyT^he-St^crnjf-frraTm^
 can register or continue registrations only of non-Federally registered
 Aldrin-Dieldrin products v/hich were produced  on or before the date
 of the Order.  Such registrations are being permitted to allow the
 orderly disposition of non-Federally registered products through
 shipment, sale, and use in the registering State.

     Any further questions regarding the Order should be directed to
 Mr. 	, EPA,  Region	, street	_,
 city,	,  State	,  telephone number     	

                                       Sincerely,

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                                              Attachment III

Types of Violations Involving Non-Federally Registered products
containing Aldrin or Dieldrin

1.  Failure of a Federal registrant to place  a statement such as "For
    use only in formulating products bearing EPA-approved FIFRA
    registrations" on manufacturing use only labels.

         Violation:  Misbranded, inadequate directions
                    Section  12(a)(l)(E)
           Action:  Civil/Criminal/Stop Sale

2.  Use of a "manufacturing  use only" product bearing a statement such
    as "For use only in formulating products bearing EPA-approved
    FIFRA registrations" on the label in a non-Federally registered
    Aldrin - Dieldrin product.

         Violation:  Misuse  Section 12(a)(2XG)
         Action:    Civil/Criminal/Stop Use

3.  Sale of a non-Federally registered Aldr-in - Dieldrin product pro-
    duced after the effective  date of the Order, but before violations
   are actionable  (GO clays after publication in the Federal Register).
         Action:    Slop SaL^

4.  Sale of a non-Federally registered Aldrin-Dieldrin product pro-
    duced after the effective date of the Administrator's Order (day
    after signature) and after the date violations become enforceable
    (60 days after publication in the Federal Register).

         Violation: Ken  registration Sec.  12(a)(l)(A)
         Action:    Civil /Criminal /Stop Sale

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J*
  ^  V
      g        UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
      V
     * Vj^S^-
             Policy  and  Grants  Division     r\~\^ Jf^^
             Office  of Compliance MonltorlngJ  f\ <)

   TO:       Addressees

         Attached  Is  the  Compliance  Strategy  for  the  Cancellation
   of the  Non-wood Uses  of  the  Inorganic Arsenlcals.   On June 30,
   1988, the Agency  published "Inorganic Arsenlcals;  Intent to
   Cancel  Registrations  for  Pesticide Products Registered for Non-
   Wood  Preservative  Use; Conclusion  of  Special  Review"  in the
   FEDERAL REGISTER  (53  FR  24787).  This notice,  which Is also
   attached, cancelled all  minor  uses of Inorganic arsenlcals with
   the exception of  the  Insecticide use  of  arsenic trloxide in a
   solid formulation  and packaged In  a sealed metal  container, and
   the solid formulation of  arsenic trioxide  for  the  control  of
   moles,  gophers  and pocket gophers.  Also  attached  is  a summary
   of the  action  for  your convenience.

         The turf  herblctdal  use of  the flowable  formulation of
   calcium arsenate,  the grapefruit growth  regulator  use of lead
   arsenate, the grape fungicidal use of sodium  arsenlte, and the
   desiccant uses  of  arsenic acid on  cotton  and  okra  grown for
   seed, I.e., the major uses,  are  still under special  review
   awaiting food crop residue data  from  registrants  as requested
   under FIFRA 3
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                           -2-
     The cancellation has been appealed and a list of  those
persons appealing the cancellation Is attached.   If you  have
any questions concerning this action please contact David
Stangel of my staff at 382-3477.
Attachments

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                                ADDRESSEES
Douglas D. Campt    (TS-766C)
Edwin F. Tinsworth  (TS-767C)
Anne Lindsay        (TS-767C)
Frederick F. Stiehl (LE-134A)
Mark Greenwood      (LE-132A)
A. E. Conroy I I      (EN-342)
Connie Musgrove        w
John J. Neylan I 11     "
David DulI             "
Mike Wood
PhylI is Flaherty
Jerry Stubbs
Maureen Lydon
Ken Kanagalingam
Bob Zisa
Sherry SterlIng
                            it
                            it
                            it
                            it
                            it
                            n
                            ii
     Jake Mackenzie
     Western Regional  Compliance Director
I     Louis F. Gitto, Director
     Air Management Division

LJ   Barbara Metzger, Director
     Environmental  Services Division

III  Stephen R. Wassersug, Director
     Hazardous Waste Management Div

IV   Winston A. Smith, Director
     Air, Pest. & Toxics Mangt. Div

V    William H. Sanders III, Director
     Environmental  Services Division

VI   William B. Hathaway,  Director
     Air, Pesticides & Toxic Division

VII  William  A. Spratlln, Director
     Air and Toxics Division

VIII Irwln L. DIcksteIn, Director
     Air and Toxics Division

IX   David P. Howekamp, Director
     Air Management Division

X    Gary O'Neal, Director
     Air and Toxics Division
                                   Marvin Rosenstein, Chief
                                   Pesticides 4 Toxic Substances Br

                                   Ernest Regna, Chief
                                   Pesticides 4 Toxic Substances Br

                                   Larry Mi Iler, Chief
                                   Toxic 4 Pesticides Branch

                                   Richard DuBcse, Chief
                                   Pesticides 4 Toxic Substances Br

                                   PhylI Is Reed, Chief
                                   Pesticides 4 Toxic Substances Br

                                   Robert Murphy, Chief
                                   Pesticides 4 Toxic Substances Br

                                   Carl Walters, Acting Chief
                                   Pesticides 4 Toxic Substances Br

                                   Alvln Yorke, Chief
                                   Toxic Substances Branch

                                   Davis Bernstein, Chief
                                   Pesticides 4 Toxics Branch

                                   Kenneth Feigner, Chief
                                   Pesticides 4 Toxic Substances Br
cc:  Michael  Walker      (LE-134P)
     Jim Roeloffs        (TS-788)
     John Tlce           (TS-769C)

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        COMPLIANCE STRATEGY FOR THE CANCELLATION OF
          NONWOOD USES OF THE INORGANIC ARSENICALS
OVERVIEW	

     On June 30, 1988, the Agency published "Inorganic
Arsenicals; Intent to Cancel Registrations for Pesticide
Products Registered for Non-Wood Preservative Use; Conclusion
of Special  Review" in the FEDERAL REGISTER (53 FR 24787),
which cancelled all minor uses of Inorganic arsenicals with the
exception of the Insecticide use of arsenic trioxide in a solid
formulation and packaged In a sealed metal container, and the
solid formulation of arsenic trioxide for the control of moles,
gophers and pocket gophers.

     The turf herblcidal use of the flowable formulation of
calcium arsenate, the grapefruit growth regulator use of lead
arsenate, the grape funglcldal use of sodium arsenlte, and the
desiccant uses of arsenic acid on cotton and okra grown for
seed, i.e., the major uses, are still under special  review
awaiting food crop residue data from registrants requested
under FIFRA 3(c)(2)(B).  A reassessment of the carcinogenic
potency of Inorganic arsenic as it relates to dietary and
dermal  exposures will be conducted when this data Is received.
REQUIREMENTS OF THE RULE	

     All minor uses of inorganic arsenicals with the exception
of the  Insecticide use of arsenic trioxide in a solid
formulation and packaged in a sealed metal container, and the
solid formulation of arsenic trioxide for the control of moles,
gophers and pocket gophers are cancelled effective August 8,
1988.  Manufacturers of cancelled products are required to
notify their distributors of the time limits on distribution
and sale of cancelled products in the possession of the
distributor by July 25, 1988, and to keep records of the date
of contact with the distributor.

Regulated Industry	

     All registrants, producers, distributors, and users of the
minor use products of Inorganic arsenlcals with the exception
of arsenic trioxide products registered as an insecticide for
use In a solid formulation and packaged in a sealed metal
container or as a solid formulation for the control of moles
gophers and pocket gophers.  This action affects 45 registrants
producing 60 products.

-------
                             -2-
Ex I st I ng Stocks
     As of August 8, 1988, no existing stock of  any cancelled
product may be distributed, sold, offered for sale, held  for
sale, shipped, delivered for shipment, or received and (having
so received) delivered or offered to deliver, or used.  This
includes products voluntarily cancelled which would otherwise
still be allowed to be sold under the terms of the voluntary
cancellation.  Persons holding existing stocks of cancelled
products must dispose of them In accordance with the applicable
requirements of the Resource Conservation and Recovery Act
(RCRA).  NoncompI Iance with the cancellation order is a
violation of FIFRA  1 2(a)(1 )(A) and 12(a)(2)(K).
COMPLIANCE MONITORING	

     Compliance with the NOIC will be determined by inspection
of registrants and producers of cancelled products to determine
If production and sale for distribution within the U.S.  has
ceased and that distributors have been notified of the action
as required by the Notice.  These Inspections are to be  carried
out within 6 months of receipt of this compliance strategy.
During routine inspections of dealers and users. Inspectors
should ensure that cancelled products are no longer being  sold
or used.  Tips and complaints are to be investigated as
rece ived .

Neutral Administrative Inspection Scheme	

     Since the issuance of the Cancellation Order Is an
administrative action which cancels all minor non-wood
preservative uses of the inorganic arsenicals with the
exception of the two previously mentioned uses of arsenic
trioxide, Inspections for violations of this cancellation  order
will take place within the existing compliance monitoring
framework.
ALLOCATION OF RESPONSIBILITIES	

Office of Pesticide Programs	

Will develop and provide OCM with a list of products affected
by this Notice and their registration status.

Office of Compliance Monitoring	

WIN develop and transmit the Compliance Monitoring Strategy to
the Regions.

-------
                             -3-
WMI transmit the list of those products which  have been
cancelled to the Regions.

Will transmit the list of registrants and producing
establishments of Inorganic arsenicals to the Regions.

Reg ions	

Will provide copies of the Compliance Monitoring Strategy to
the States.

Will distribute a list of products, registrants and producing
establishments affected by this Notice to the States.

Will conduct Inspections in States without Cooperative
Enforcement Agreements as part of their routine Inspectional
schedule.

Will take enforcement actions as appropriate.

States	

Will conduct Inspections of registrants within  6 months of
receipt of the compliance strategy.

Will conduct inspections of dealers as part of  their routine
inspectional schedule.

Will take enforcement actions as appropriate.

Will report to the Regions on actions taken under this  Notice

-------
     INORGANIC ARSENICALS NON-WOOD PRESERVATIVE USES
               NOTICE OF INTENT TO CANCEL


All non-wood preservative uses of inorganic arsenical pesticide
products are cancelled effective August 8, 1988, with the
exception of the following uses.


The following registrations will be retained without change;

1.  Arsenic trioxide insecticide use (solid formulation
    manufactured in a sealed metal container only) for:

    Domestic outdoor - domestic dwellings
    Domestic indoor - domestic dwellings

2.  Arsenic trioxide mole, gopher, and pocket gopher killer use
    (solid formulation only) for:

    Domestic outdoor - domestic dwellings
    Terrestrial non-food crops - golf courses, ornamental
    plants and lawns, non-crop areas


Registrations not considered in this action;

1.  Lead arsenate plant growth regulator use on grapefruit.

2.  Sodium arsenite fungicide use on grapes.

3.  The desiccant uses of arsenic acid on okra (grown for seed)
    and cotton.

4.  The flowable formulation of calcium arsenate for use on
    turf.

Decisions on these uses are deferred pending the Agency's Risk
Assessment Council's reassessment of the carcinogenic potency
of inorganic arsenic for dermal exposure and the receipt of
dietary exposure data the Agency has requested.


Effective Dates

As of August 8, 1988, no existing stock of any cancelled
product may be distributed, sold, offered for sale, held for
sale, shipped, delivered for shipment, or received and (having
so received) delivered or offered to deliver, or used.  This
includes products voluntarily cancelled which would otherwise
still be allowed to be sold under the terms of the voluntary
cancellation.

Registrants were required to notify their distributors of
cancelled inorganic arsenical products by July 25, 1988, to
inform them of the time limitations on distribution and sale of
existing stocks in the hands of the distributor.

-------
                PARTIES REQUESTING A HEARING
Jones Products Company
Box 204
Middleton, WI  53562

Jones Ant Killer   EPA Reg. No. 29-4
Senoret Chemical Company
566 Leffingwell Ave.
Kirkwood, MO  63122

Terro Ant Killer   EPA Reg. No. 149-2
General Pest Service Co.
1819 Goldfield Street tB
North Las Vegas, NV  89030

 Jit Jex Redwood Ant Stakes   EPA Reg. No. 3324-3
Protexall Products, Inc.
1109-11 Hwy 427 N.
Longwood, FL  32750

Protexall "Ant-Kil"   EPA Reg. No. 4972-8

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,,0
          UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                      WASHINGTON, D.C. 20460
                           JUL  6
                                                        OFFICE OF
                                                 PBSTICIDCS AND TOXIC SUOSTX
 MEMORANDUM

 SUBJECT
 FROM:
 TO:
Compliance Strategy for the Conditional Registration
and" Cancellation of Certairf\$romoWni

John J. Neylan III, Director
Policy and Grants Division
Office .of Compl iance Monitori

Addressees
      On  May  5,  1989  the  Agency  approved  an  Agreement with Rhone-
 Poulenc  to conditionally amend  the-registrations  of three
 bromoxynil pesticide products  (buctril,  bronate,  and buctril  +
 atrazine), pursuant  to FIFRA  section 3(c)(7)(A).

      On  June 5,  1989 the Director  of the Office  of Pesticide
 Programs, Office of  Pesticides  and Toxic Substances, signed a
 FEDERAL  REGISTER .Notice  entitled:  "Order Cancelling Registrations
 For  Pesticide Products Containing  Bromoxynil  Butyrate."   The
 registrant requested voluntarily cancellation of  bromoxynil
 butyrate products  and proposed  to  conduct a recall  of the
 cancelled products down  to  the  user  level.

      Attached are  the Final Compliance Monitoring Strategy,  a
 summary  of the  Strategy,  a  copy of the Agreement  between  the
 registrant and  EPA,  and  the Cancellation Order.   Please  transmit
 a copy of the Strategy and  other attachments  to  the States.
 Please note  that because of the nature of this action,  this
 Compliance Strategy  is immediately effective.  If you have any
 questions or comments regarding the  Strategy,  contact Steve Howie
 (E-mail  EPA  7201,  FTS 475-7786) of my staff.

      Thank you  for your  cooperation.
Attachments

-------
                                 ADDRESSEES
 I I
IV
VI
      Douglas D. Campt     (H7501C)
      Edwin  F. TInsworth   (H7505C)
      Anne Lindsay         (H7505C)
      Frederick F.  Stlehl  (LE-134A)
                          (LE-132A)
                          (EN-342)
Mark Greenwood
A. E. Conroy  I I
Connie Musgrove
Mike Wood
Jerry Stubbs
Sherry SterI ing
David Dui l
Ken Kanagalingam
Bob Zisa
John J. Neylan III
PhylI is E. Flaherty
Maureen Lydon
      Jake Mackenzie
      Western Regional Compliance Director
                            H

                            If

                            II

                            If

                            II

                            It

                            tf

                            It
Louis F. Gltto., Director
Air Management Division

Barbara Metzger, Director '
Environmental Services Division

Stephen R. Wassersug, Director
Hazardous Waste Management Dlv

Winston A. Smith, Director
Air, Pest. 4 Toxics Mangt. Div

William H. Sanders III, Director
Environmental Services Division

WlI I iam B. Hathaway, Director
Marvin Rosensteln, Chief
Pesticides 4 Toxic Substances Br

Ernest Regna, Chief
Pesticides 4 Toxic Substances Br

Larry Ml Iler, Chief
Toxic 4 Pesticides Branch

Richard DuBose, Chief
Pesticides 4 Toxic Substances Br

PhylI is Reed, Chief
Pesticides 4 Toxic Substances Br

Robert Murphy, Chief
     Air, Pesticides 4 Toxic Division.  Pesticides 4 Toxic Substances Br
VII  William  A. Spratlln, Director
     Air and Toxics Division

VIM Irwin L. Dlcksteln, Director
     Air and Toxics Division

IX   David P. Howekamp, Director
     Air Management Division

X    Gary O'Neal, Director
     Air and Toxics Division
                                   Car.l Walter, Acting Chief
                                   Pesticides 4 Toxic Substances Br

                                   Alvln Yorke, Chief  '
                                   Toxic Substances Branch

                                   Davis Bernstein, Chief
                                   Pesticides 4 Toxics Branch

                                   Kenneth Feigner, Chief
                                   Pesticides 4 Toxic Substances Br
cc:  Michael Walker      (LE-134P)
     Jim Roeloffs        (TS-788)
     John TIce           (TS-769C)
     Al Heier            (A-107)

-------
    BROMOXYNIL CONDITIONAL  REGISTRATION  AND VOLUNTARY  CANCELLATION

              COMPLIANCE MONITORING STRATEGY SUMMARY  SHEET
  1.    Conditional Registration of  products  containing Buctril,
        Bronate,  and  Buctril  + Atrazine.
TARGET DATE FOR
INSPECTION
          CONDITIONS OF  REGISTRATION TO BE MONITORED BY
          INSPECTION
                                                       LEY
by 8/7/89
by 9/6/89*
Restickering of products released for shipment
after 5/5/89; Stickers sent to dealers for
relabeling by 5/15/89.
Restickering of dealer stocks carried out by
Registr
Produce
Distrifc
by 9/6/89*
between 10/1/89
and 11/1/89
between 10/1/89
and Spring,  1990
growing season
          5/25/89;  Point-of-purchase communication carried
          out by registrant per schedule in  conditions of
          registration.

          Used only by certified applicators according to        User
          conditions of  registration.

          Revised Labelling on all products  by  10/1/89; all     - Registr
          bulk containers  have correct transfer mechanism by     Produce
          10/1/89.

          Compliance with  EPA-approved user  training plan.       Registry
          Plan must be implemented prior to  1990 Spring          User
          growing season.                                       Interfac
  2.
Vp] untary Cajicel lation of  Broiaoxynil Butyrate  Products**

                                                               LEVEL
TARGET DATE FOR
INSPECTION
ACTIVITY TO  BE MONITORED BY INSPECTION,
PER TARGET DATE
by 8/7/89


by 9/6/89*

by 9/6/89*
          No shipments  intended for sale/use  after 6/12/89


          No sale after 6/12/89

          No use after  6/12/89
                                                     Registrar
                                                     Producer

                                                     Distribui

                                                     User
*    As part of routine inspections.

**   Includes the following products: Dragonmate, ME 4 Bromfnal, Torch Twin  Pak, 3+3
     Brominal, Bromoxynil Butyrate  Technical, Certrol, and  Buctril 4 EC.

-------
            COMPLIANCE STRATEGY FOR THE CONDITIONAL  REGISTRATION
              AND CANCELLATION OF CERTAIN BROMOXYNIL PRODUCTS
OVERVIEW	:	

     Bromoxynil is 'a  selective, postemergence herbicide used to
control broadleaf weeds primarily in field corn, wheat, garlic,
barley, oats, rye, sorghum, onions and flax.  Most use occurs
between February and  June on small grains and corn.

     On May 5, 1989 the Agency approved an Agreement with Rhone-
Pou,lenc to conditionally amend the registrations of three
bromoxynil pesticide  products (buctril, bronate, and buctril +
atrazine), pursuant to FIFRA section 3(c)(7)(A).

     On June 5, 1989  the Director of the Office of Pesticide
Programs, Office of Pesticides and Toxic Substances, signed a
FEDERAL REGISTER Notice entitled: "Order Cancelling Registrations
For Pesticide Products Containing Bromoxynil Butyrate."  The
registrant requested  voluntarily cancellation of bromoxynil
butyrate products and proposed to condu'ct a recall of the
cancelled products down to the user level.
REGULATED COMMUNITY	

     Rhone-Poulenc, the only registrant, producers,
distributors, and users of bromoxynil are affected by the
Agreement and the Cancellation Order, although responsibility
for meeting the terms of the conditional registration Agreement
is on the registrant.  At the time of the Agreement and
Cancellation Order there were 8 registrations and 6 producer
establishments.  A list of these can be found in the Appendix.
REQUIREMENTS QF CONDITIONAL REGISTRATION	

     Under FIFRA Section 3(c)(7)(A), EPA.has imposed certain
conditions for the continued registration of three bromoxynil
octanoate products (buctril, bronate, and buctril + atrazine).
These conditions include adding warning statements to the
product labels stating that exposure during pregnancy causes
birth defects in laboratory animals, restricting its use to
certified .applicators, and requiring additional protective
clothing for mixers, loaders and applicators.

     The registrant is also required to conduct an extensive
notification and educational program for bromoxynil users to
inform them of the potential birth defect risks for mixing,
loading and applying bromoxynil as well as the importance of
following the new risk reduction measures.

     The registrant is also required to provide extensive
data within specified time frames and interim reports to enable

-------
                                     -2-

 the  Agency to better estimate the magnitude  of  risk  to exposed
 workers.

 Stocks  of Products with Amended Sticker ina/Labelincr	
      By May 6,  1989 the registrant was  required  to halt  shipment
 of  all  bromoxynil products until approved amended stickers are
 affixed to each container within the company's possession.

      By May 15, 1989,  the registrant was  required to provide
 each distributor holding inventory of bromoxynil products
 sufficient stickers for such inventory.

      By" May 25, 1989 the registrant was required to provide each
 reseller and retailer holding inventory of bromoxynil products
 sufficient stickers for such inventory.
            >
      The registrant was also required to  provide each
 distributor, reseller, and retailer with  instructions concerning
 the manner in which the sticker must be affixed  to each
 container, and to implement the attached  labeling communication
 plan by the dates described therein.

      The registrant is also required to assume responsibility
 for insuring that each distributor, reseller or  retailer
 attaches the sticker to each container  which is  sold or
 distributed by the distributor, reseller  or retailer after the
 date the stickers are received.

      After October 1,  1989, revised labeling, which deletes all
 claims, references, and use directions  pertaining to the
.previously permissible uses for turf and  non-crop areas, and
 which includes all new label provisions as required by the
 agreement, must be attached to the containers of all bromoxynil 
 products released for shipment by the registrant.

 Additional Requirements	

      By October 1, 1989, the registrant must develop and submit
 to  EPA  a proposed program to provide additional  training to
 users of bromoxynil products prior to the 1990 spring use season
 and will implement the program once it  has been  approved by EPA.

      By October 1, 1989, the registrant  is also  required to
 establish a. program to provide assistance to users who do not
 own a mechanical transfer system which  terminates  in a drop-
 free hard coupling and who wish to obtain such a system  or to
 modify  their present system.

      After October l, 1989, the registrant is required to  insure
 that all bulk containers released for shipment  include a
 mechanical transfer mechanism which terminates  in a drip-free
 hard coupling which may be used only with a spray or mix tank
 which has been fitted with a compatible coupling.

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                                    -3-


     By January 1, 1990, the registrant is required to have
 investigated and reported to EPA, the feasibility of packaging
 bromoxynil products  in containers which are smaller than 30
 gallons and which  include a hard coupling designed for use with
 a specific closed  mixing and loading system.

     By  specified dates, the registrant is required to develop
 and submit rabbit  dermal teratology, male reproduction effects
 and worker exposure  studies to EPA.  The agreement requires the
 registrant to submit one- line, status reports on each required
 study on at least  a  quarterly basis to EPA.


 CONDITIONS OF CANCELLATION

     All pesticide products containing bromoxynil butyrate were
 automatically canceled, effective the day following publication
 of the Cancellation  Order in the Federal Register.

 Recall    _ : _

     In their request for voluntarily cancellation, the Company
 stated that it would institute a plan to recover remaining
 stocks of these products from distributors, dealers, and users.

 Existing Stocks _

     Sale, distribution and use of existing stocks of bromoxynil
 butyrate product now in the possession of distributors, retailers
 and end-users is not permitted after the date of publication of
 the Cancellation Order in the Federal Register.  The registrant
 also .indicated that  they will accept for disposal any stocks of
 bromoxynil butyrate  products turned in by distributors, dealers
 and end-users.  Persons holding existing stocks of cancelled
 bromoxynil butyrate  products must dispose of them in accordance
 with the applicable  requirements of the Resource Conservation and
 Recovery Act (RCRA) .  Noncompliance with the cancellation order
 or its terms is a  violation of FIFRA sections 12(a)(l)(A) and/or
COMPLIANCE MONITORING
Regional/State Activities
     Inspections will.be conducted by the States and EPA  (in
non-grant states) to monitor complitance with the Conditional
Registration" Agreement and the Canc'e Hat ion 'Order.  This will be
accomplished through registrant; producer establishment, and
marketplace inspections.  Enforcement actions regarding the
Cancellation Order will be taken, as appropriate, by the States
and Regions, with reports of such actions and/or potential
violations made to EPA headquarters.  States and Regions will
also report to EPA headquarters all violations or potential

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                                     -4-

 and  Regions,  with reports  of  such actions and/or potential
 violations  made to EPA headquarters.  States and Regions win
 also report to EPA headquarters  all  violations or potential
 violations  of the conditions  of  registration of bromoxynil
 octanoate products.

 Registrant/Producer Level	

      Within 30 days of the date  of this strategy, the
 Regions/States will schedule  and conduct inspections of Rhone-
 Poulenc's producer establishments to obtain assurance that the
 company has complied with  the requirements of the May 5, 1989
 Agreement "by  not having released products for shipment without
 the  amended stickers,  and  the June 5, 1989 Cancellation Order
 to determine  if production and sale  for distribution of
 cancelled bromoxynil products within the U.S. has ceased.
 Information obtained during inspections of registrants records
 regarding disposition of stocks  of conditionally registered and
 cancelled products should  be  forwarded to other Regions for
 their use in  scheduling inspections.

      After  October 1,  1989 inspections at producer
 establishments will assure that  all  products released for
 shipment by the registrant have  the  required revised labelling,
 and  that all  bulk containers  released for shipment include the
 required mechanical transfer  mechanism with a drip-free hard
 coupling.

      After  October 1,  1989, and  before the Spring 1990 planting
 season, inspections will be conducted to determine registrant
 compliance  with the EPA-apprbved plan for user training and
 assistance.   This plan will be sent  to the States and Regions
 following its approval.  The  inspections will be appropriately
 directed at the registrant-user  interface and may, for example,
 include monitoring or  inspection of  training sessions/materials
 by Regions  or States.

      within 60 days of the date  of this strategy, the
 Regions/States will follow-up and track the recall of the
 cancelled bromoxynil butyrate products, that the registrant is
 undertaking,  following the outlines  in section 14 of the
 Pesticides  Inspection  Manual.

Distributor/Reseller/Retail Level

      Within 60 days of the date  of this strategy, the
Regions/States will inspect,  during  routine scheduled
 inspections,  distributors,  resellers, and retailers to assure
 that  the registrant has adhered  to the time frames and
 requirements  listed above  under  "Requirements of Conditional
Registration," and the June 5, 1989  Cancellation Order to
determine if  sale and  distribution of cancelled bromoxynil
butyrate products within the  U.S. has ceased.

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                                    -5-            .  .

User Level	

     Within 60 days of the date of this strategy, inspectors
will assure, during routine scheduled inspections, that non-
cancelled bromoxyni.l products are being used only by certified
applicators and in accordance with the use directions and
protective clothing requirements on the amended sticker/label,
and that cancelled bromoxynil butyrate products are not being
used.
ALLOCATION OF RESPONSIBILITIES
       of Pesticide
Will develop and provide OCM with a list of all products
affected by the Conditional Registration Agreement and the
Cancellation Order.

Office of Compliance Monitoring _  _
Will develop and transmit the Compliance Monitoring Strategy to
the Regions.

Will receive quarterly reports from Regions for one year
following the date of this Strategy.

Will transmit to the Regions a list of those affected products
and a list of producing establishments.

Will transmit to OPP any information regarding violation of the
conditions of registration.

Regions	
Will provide copies of the Compliance Monitoring Strategy to
States.

Will report quarterly to the Director of the Compliance
Division, OCM detailing State inspection activities per their
quarterly reports, for one year following the date of trhis
Strategy.

Will distribute a list of products, and producing establishments
to the States.

Will conduct inspections in States without Cooperative
Enforcement Agreements as specified in this Strategy.

Will take enforcement action as appropriate.

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                                    -6-

noncompliance with  the requirements of the Agreement,.including
information on tips and complaints received.

Will report to the  Director of the Compliance Division, OCM
regarding violations of the conditions of registrations
immediately upon receiving such information.

Spates	'.	

Will conduct inspections as specified in this Strategy.

Will make quarterly reports to.the Regions detailing the number
and dates-of inspections related to this Strategy, for one year
after the date of this Strategy.

Will take enforcement action as appropriate provided they have
the authority.

Will report to the  Regions on potential violations of the
bromoxynil conditional registration agreement, including
whether training and assistance activities are conducted, and
enforcement actions for violations of'the Cancellation Order.
Reports will be submitted within two weeks of knowledge of
violation or enforcement action.

Will investigate tips and complaints as received.  If States
receive information which indicates possible noncdmpiiance with
the .Agreement , they should-investigate to ensure compliance.

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                                            APPENDIX

                 BRQMOXYNIL REGISTRANT, PRODUCTS, AND PRODUCING ESTABLISHMENTS  (1985-87)
Rhone-Poulenc AG Company
P.O. Box 12014 2 T.W. Alexander Drive
Research Triangle Park, NC 27709
Product Name

Buctril*
EPA Reg. No.

  264-437
Broot 15GX (Bronate)*    264-438
  il    II
Buctril + Atrazine*

ME 4 Brominal
(Buctril ME 4)**
(Also produced as
3+3 Brominal
and Torch Twin Pack)
  264-477


  264-340
 Estab. No.

 264-OR-001



 264-OR-001

 264-IA-001
Estab. Address

Rhone-Poulenc AG Company
6200 W St. Helens Rd.
Portland, OR  97210
                                                            Rhone-Poulenc AG Co
                                                            2100 S 21st St.
                                                            Clinton,  IA  52732
 No USA Production Records for 1985-88
 264-MO-001
Rhone-Poulenc
PO Box 367
317 West Florence Rd
St. Joseph, MO  64502
Buctril 4 EC'**

Certrol**
  264-474

  264-421
                                            264-NC-001
                                          55259-IL-001
                                           2393-IL-003
                                     Rhone-Poulenc AG Company
                                     T.W. Alexander Dr
                                     Research Triangle Pk, NC  27709

                                     Bradford Ag Service Inc.
                                     401 Phoenix Ave
                                     Bradford, IL  61421

                                     Hopkins Agri. Chemical Co.
                                     303 SU Arch St.
                                     Atlanta, IL  61723
 No USA Production Records for 1965-88

 264-MO-001      Rhone-Poulenc AG Company
                 PO Box 367
                 317 West Florence Road
                 St. Joseph, MO  64502

2393-IL-003      Hopkins Agricultural Chemical Co
                 303 SW Arch St.
                 Atlanta, IL  61723

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                                              -2-
Dragormate Broadleaf     264-339
 Herbicide**
264-MO-001
Rhone-Poulenc
PO Box 367
317 West Florence Rd
St. Joseph, MO  64502
* conditionally registered products.

** Registrant has requested voluntary cancellation of these registered products and they are
cancelled by the cancellation order published in the FEDERAL REGISTER (54 FR 24948).

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                       Federal  Register / Vol. =14.  No.  Ill /  Monday.  June  12. 1989 /  Notices
                                                                                  24949
    Name o4 aoohcarM
                             Locauon
                                                       Protect dcscnnon
                                             Reviewing agency
                                                                                                                       Dmeot imel
                                                                                                                         action
Long latand lighting Co. >	' Weet Babylon. NY.

Naaaau Ciatnet Energy Cars.., unondale. NY	
Karrane Cirthage Cogenera- ' driftage. NY	
  don Co . Inc.           I
Momll Press Co	I Fultan, NY		

Kam.re Sou* Glens  Fi.a  Soctn Glens FaJa.
  Co5enrat.'cn Co., Inc.    .   NY
inaeck-vertm energy Sarv-  Tjnawarwa. MY- ....
  cea. Inc
Hoise Cascade Corp	; 3ee-ei ri.'s, NY
        La Pocfe Inc	 Betvidero. NJ
         c	; PaCT!. NJ ..-	

Long island Ugntmp Co	 Snor.in.irn. NY	

Ufe Severs. lr-c	! Las Piedrms. Pa	


Aooon Laboratories	_... Sarcetoneta, PB..

Mec^n-^acine.  Assesses. ' Carson. NY	
  inc.                   :
United Development Gtotav j Niagara Faiia. NY..
  Niagara, inc.            i
Town of Norm Kempstead  Por: V/asrvngton.
  Solid waste Management]   NY.
  Autncrr/.              \
L4J Energy Systems. Inc	 howw;*. NY	

Pennsautien  Solid  W.te  PeV:i- an 11 station rotograwe press and
    modrtcaton of an a stamen rotogravure press.
  CornruOJOn at a 50 NW gas tureme/ steam gener-
    S'-X.
  Co'-Jtrjctjon of a S3 MW jas turome.'steam gcner-
    a;or.
  Rec-accrrnt of  an  existing oiMired 6o*ar mn a
    now oil-fired  ooiter.

  Revision ol me mregsn oude errussnn tout piew
         permitted tor  a 23.3 MW coganeraticn
      item.
         ol tne sarocusae maner  emawen (bin
            perrmned tar trvaw ooaHved DoMra.
            ol a 220 MW gas turbine gcneraeon
    facdtyS
 ' ConstrucaVn of a new  stesm bpaar and  new
 >   gtmermiorV^nd cenoeisMn of an emng generav
 !   tor and boner to standoy operaoon.
 : Re'.,s:on ol tn\PM emission Omit previously permrt-
 ;   ted lor a 20 ?"WW  cogeneratci laolrty.
 , Construction ol \19 MW gas turom*/steam gener-
    ator.
 : Construction ol a cdy fired cogeneration system.
  Construction of a 990 i
    resources recovery I

  Construction ol a 49 MW (
    ator.
  Corstruction ol fio 250
    3.M waste niui.aaxis.
                                                              i per day municipal waste
                                                                 i airdme/steam janer-

                                                                    per day muntopai
NYSCeC 	
NYSCEC
.NYSOEC 	
NYSDEC
NYSDEC. 	
NYSDEC .
NYSDEC .
SPA region II....
EPAImonU....
NYSCECs
\
EPA region 11 
\
EPA region H ...
NYSDEC 	
NYSDEC
uvencr*
NYSCEC 	
NJOEP 	






V"
..J

	
PSO pern*
do
do
do
do
Ml
PSO norv
epptocabtifty
determination.
PSO perm* rei*on...
	 do 	 ___. 	 '.
PSD penurt
approval. |
PSOnorv ,
applicability {
deterrranaoon. {
PSO perm HKUMI..J
PSOperrart
\ approval.
\oo ,.. 	
\
aporov*\
	 go 	 .\..' 	
 7/18/88

10/07/88
10/19/88

'2/05/88

12/09/88

 t/09/89

 1/11/99


 1/17/89


 I/17;89

 1/23/89

 3/01/89


 3/06/89

 3/06,89

 3/10/39

 3/1S/89


 3/20/89

 4/20/89
>ssues were rsv>^ea during an >ssu envvonmerral
   tecticn  This ?*:mt ni'M "ave beccn'v 'toc!ve on M.rcn 13. '9i9 rt no pes'jon for aomsmsirasve review was filed wnft tne EPA Adrmrtisffaior ?n Waspinaion.
CC. Hcxwver.  a oetmon tor revww rjs *< ? TT>e Tawrinip 51 Cinnarr.mson, tfe Sorougn at Palmyra, and tne Borougn ot Rivenon on Marcn 7. 1989. On  AwH 20.
1989. "19  EPA AarruTHstratar oacEC  a".ei ca.-e^i revie of tfe appeal not to grant fu.-r^r revic\ c-t tt>o oetmon. Therefore, me PSWMS PSO permn s erlec^ei s
ol.AD.il 20. 198J.
    us notico lists oniy the sources that
     i received finai PSD dete^ninatior.-s.
Anyone who wishes to review these
           ions and related materials
should Contact tl.s following offices:

EPA Actions
I'nitod Stat>js.Env:ror.rr.entai Protection
  Agency, r -^on II Oi::^e. Permits
  AJ:nin:stra;ion Branchtvocrri 505. 26
  Fsr.-.Tdl P;..2d.\'ew Yoik. New York
  li.'2'3.

NYSDEC Acuons
N'ew York State Dppnr^rient of
  Environmkiita'i Ccrseryatton. Division
  of Air Resources. ourc\Rev:aw and
  Re-.vunil Support Section\5n Wolf
  Road. AIL-jny. New York '\23J-OOCn.

NID'EP Actions
.''ei% Jersey n-.-p^rrment of
  Er.vjronrr.i ntul Protection. D.v.iiJyi of
  ^n\ironme!:.di QiM::;y. D'.ireju of
  F:r.i.-:neer;n^ A Technoii  ;y 401 Er:st>
                                             jtate Street Trenton. New Jersey
                                               825.
                                                Available pursuant to the
                                             ConsolidatEd Permit Regulations (40
                                             CFR P\rt 124). j'ldicial review of these
                                             cletermiKations under section 307(b)(l)
                                             of the Clefcn Air Act (the Act) aiay be
                                             souaht or.ly\by the f:;:r.g of a peti'ion for
                                             review in thai'nited States Court cf
                                             Appeals for ths. appropriate circuit
                                             within 60 days Item the date on which
                                             these de'erminatrdns are published in
                                             the Federal Register. Under section
                                             307(b)(2) of ihe Act. Jhcae
                                             determinations shall nSt be subject to
                                             later judicial review in cvv:l or i:ri."ir.al
                                             proceedings for cr.fo

                                               Dated:  [une 1.1969.

                                             William |. Mui}-nskJ,
                                             ;:H Doc. 3^-1.1349 Filed 6-9-38: 8 4S .i-.f

                                             8XLIKG C=CE ISCO-SO-M
                                                 IOPP-66131; FW.-3600-4J

                                                 Order Canceling Registration for
                                                 Pesticide Product* Containing
                                                 Bromoxynil Butyrate
                                                 AGENCY: En^rynmental Protection
                                                 Agency (EPA).
                                                 ACTION: Cancellation notice and order.

                                                 CUMMAKY: This no ace announces EPA's
                                                 decision to cancel all registrations
                                                 i-.-sued under the Federal Insecticide.
                                                 Fungicide, and Rodenticicie Act (F1FRA)
                                                 for pesticide products containing the
                                                 butyric acid ester of bromoxynil (3.3-
                                                 dibromo-i-hydroxybenzontLrile). The
                                                 Mgistrmt Rhone-Poulenc AC Company
                                                 has requested voluntary cancellation of
                                                 these products. Because of the
                                                 ucvclcpmental  risks associated wiih
                                                 exposure to these products, EPA will noi
                                                 permit and the  cancellation order will
                                                 explicitly prohibit the sale, distribution.
                                                 a,id use of existing stocks of affected
                                                 products.

-------
24-J.-0
Federal  Register
Mor.ci.i
                                                             inrt'.i .   \\
DATE: The carccildtion order
incorporated in this notice will become
effective June 13. 1989.
FOR FURTHER INFORMATION CONTACT:
|ui<.' Andreasen. Special Review/
  Rnrcjjistration Division {H"08Q.
  Office of Pesticide Progr.ims.
  !!.:. :mr.rp(?ntal Protection Awcncy. -Jiil
  M S(r-L't SW.. Washington. DC 20400
Office location and telephone number
  F.~. lOOtjF CM =:. 1CU1 Jefferson
  D.iv:s Hijjh'.vriy.  Arlington. VA. ("0"!
  5j--ll"0.
SUPPLEMENTARY INFORMATION:

I. Request for Voluntary Cancellation
  On May 1.1989.  js a result of
discussfon  between EPA and Rhone-
PG.:! JP.C AC Company concerning
measures to minimize potential risk of
developmental toxicity associated  with
exposure to bromoxynil. Rhone-Poulcnc
requested voluntary cancellation of its
registered pesticide products containing
bromoxynil butyrate (the butyric acid
ester of 3.5-dibromo-4-
hydroxybenzonitrile). Rhone-Poulenc
stated in its request that it would
institute a plan to recover remaining
stocks of these products from
distributors, dealers, and users. Under
this plan. Rhone-Poulenc will replace
these products with an equal quantity of
a corresponding product containing
bromoxynil octanoate. and will pay
shipping and handling costs.
Distributors and dealers holding  stocks
of affected products should contact
Rhjne-Poulenc customer service. Users
holding stocks of affected products
should return them to the dealer.
  Rhone-Poulenc had previously
requested voluntary cancellation of a
number of registered bromoxynil
products, including some but not all of
its products containing bromoxynil
butyrate. on October 27.1988. EPA
canceled certain bromoxynil products
pursuant to this request, but was
unwilling to accept the remaining
requests for voluntary cancellation
because those requests were made
contingent on the Agency's permission
to sell and use existing stocks of
affected products.  Given the unresolved
concerns regarding the developmental
toxicity of bromoxyiuL EPA considered
it inappropriate to  issue an existing
stocks order for such products.

n. Existing Stock*
  In its May 1.1988 letter. Rhone-
Poulenc did not request that EPA permit
the sale, distribution, or use of existing
stocks of canceled products containing
bromoxynil butyrate. EPA has
determined that continued use of
products containing bromoxynil
                   butyriite would present d.n un;icci'pt.:i'ii;
                   r:sk of developmental toxicity :n persons
                   handhra sur.h products. Acccrdinyly.
                   EPA will nnt permit the continued s.ile.
                   distribution or tr.e of any cancc!r>J
                   product cnnt.-i:r:nt: h-orr.otyr.i! ru-tyr^L1.
                   EPA enrouraui'S ail pers.-r.s holding
                   stocks of c.-injelt-'d prod--ic;s cont.i;;::na
                   bromoxynii nutvrate to p;i:-.n;:pjte in the
                   recovery prog-am e?t.-,l>iishcd by Rhcne-
                   Pouler.c.

                   III. Cancellation Order

                     Effective June 1.1. :?fi9. the
                   registrations for jl! pesticide products
                   containing the butyr-c aci J ester cf
                   bromoxynil (3.5-Jibromo-4-
                   hydroxyber.zonitrile) are canceled
                   pursuant to section 6(f)[l) of FIFRA, 7
                   U.S.C. 136d(f](l). Effective June 13. 1989.
                   it shall be unlawful under FIFRA section
                   12fa)(l)(A) and/or FiFRA section
                   12(a)(;)fK). 7 U.S.C 136j(a)(l)(A).
                   i36j(a)(2)(K). for any person to distribute
                   or sell, or to use for any pesticidal
                   purpose, any of the following canceled
                   products containing the butyric acid
                   ester of bromoxynil:

                      EPA    1 . Previous   I
                    registration I  registration  !      Product
                      No.    ;    NO.     !	

                      264-339 :	' Oragonmat*
                      264-340 (	 ME 4 arcminal.
                      264-340 '	 Torcn Twin Pa*.
                      264-340 	j 3-3 Srominal
                      264-3JM I	; Bromovntf Bulyrale
                             I
                                          Technical
                      264.421 	Certrot
                      264.474     33-7!6 Suctnl 4 EC.
                     This Order docs not prohibit any
                   shipments of canceled products
                   containing the butyric acid ester of
                   bromoxynil which are associated with
                   the program to recover stocks of such
                   products established by Rhone-Poulcnc
                   AC Company, or which are otherwise
                   necessary to facilitate proper storage or
                   disposal of such products.
                     Dated: June S. 1989.
                   Douglas O. Campt
                   Director. Office of Pesticide Progress.
                   (FR Doc 89-13646 Filed 6-9-89: 8:45 air.J
                   MLUNO COOC IMO-W-M
                         RAL MARITIME COMMISSION

                   AgreernfeqUs) Filed
                     The FederaXMaritime Commission
                   hereby gives nomeof the filing of the
                   following agreements! pursuant to
                   section 5 of the Shippiflg^ct of 1984.
                     Interested parties may ihoect and
                   obtain a copy of each agreement at the
                   Washington. DC Office of the Federal
                   Maritime  Commission. 1100 L Stree
                  \\w . Kn,j!:i ;ir,25  ;.-.:,-.-MLJ :
                    i;iy submit ci'T.jvi.-r-.ts c'.'i r."-~.
                  ^roomer.: -1' ^A(" ?' ' '''''  F, ..

                      (3. tviihin 10 d.iys ^f'er 'he
                       udcrul Register :.-. -.:. ^ "
                  appe\fs. The rerju.-r-'rnLT/s fcr
                          'j ;ire four.J in  5 ".;. 
                  r, of th\ Code of Fi-ioral R. 
                  Iiiierts.oCi persons --houiii c-..:.--
                               i ciiR:rr...i"!i;i'!.r j >
                              .'!"' Firti:."!^ d pfrc'~:
  Ti.-ft.: Su;:ln\
Conference ("t
                                     e  I' S.A.
                     Achille Lauro
                     Compania TrasA;!an::ca Esrar.
                       S.A.
                     Ccsta Container L\ne (a Du is:
                       Contship Contairierlines Lir-
                     d'Amico Societa di .Nav:gaz:cr.
                       S.P.A.            \
                     Evergreen Marine Corporation
                       (Taiwan) Ltd.       \
                     Farrell Lines. Inc.       \
                     "Italia" di N'avigazione S/p.A.
                     Jogolinija                \
                     Jugooceanija             \
                     Lykes Lines (Lykes Bros. Steam
                       Co.. Ltd.)
                     A.P. Mcller-Maersk Line
                     Nedlloyd Lir.es (N'edlloyd Lijr.c.
                     Sea-Land Service. Inc.
                     P 4 O Containers (TrLl Ltd.
                     Zim Israel Navigation Co Tip-any
                     \nopsis: The proposed moc:fic
                   would permit any member to
                   disassociate itself from any Cor.fe;
                   actionVi a rate or service item tha
                   would rqsult in a reduction in the c
                   cost per oargo unit to the  shipper b
                   giving written notice to the other
                   members pmir to the time the rate
                   service item lias been filed with th<
                   FMC and become effective.
                     Agreement No.: 217-010738-003.
                     Title: Barber Blue Sea/Open dull
                   Carriers Chartering Agreement.
                     Parties:
                     Wilhelmsen LinesV-t/S
                     Open Bulk CarrienSLimited
                     Synopsis: The proposed modifies
                   would authorize the pariies to disci.
                   and agree upon rates, charges and c
                   competitive matters regarding
                   intermodal movements. It would als
                   permit the parties to agree upon sai.
                   schedules, service frequency. nd p<
                   to be served by each party. It would
                   further make other non-substantvve
                   administrative changes.        \
                     Agreement No.: 232-Olll84-002.\
                     Title: Evergreen Marine Corpora:i
                   (Taiwan) Ltd. Italia di Navigaziortc .'

-------
    <>.

     \      UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
      "i
      '                  WASHINGTON. D.C. 20460
                                                             e or
  -- -                                           '  'CSTICIOBS ANO TOXIC SUBST/

Mr.- Nick Somma.
Rhone-Poulenc Ag. Company                                 ... _
P.O.- BOX 12014
2 T.w.  Alexander Drive
Research -Triangle Park, NC 27709

Dear Mr. Somma:

Subject:  Application for Conditional Amendment - Revised
         .Labeling/Restricted Use Classification/Data
          Requirements/Additional Conditions .
          Buctril Herbicide
          EPA Registration No. 264-437
          Bronate Herbicide '
          EPA Registration No. 264-438
          Buctril + Atrazine Herbicide
          EPA Registration No. 264-477
          Your Submission Dated May 1,  1989

     Your application dated May 1, 1989 to conditionally amend  the
subject pesticide registrations to incorporate  revised  labeling,
a new classification for restricted use, additional claims-, and
specific conditions for continued registration  is granted,
effective immediately.  -Continued registration  of these
pesticides win be contingent on satisfaction of each of the
conditions set forth in the approved amendment.  Please submit
for each of the subject registrations five  (5)  copies of the
final printed stickers incorporating this amendment.  A stamper
copy of the approved text for these stickers is enclosed for  your
records.
                                  Sincerely  yours,
                                            Taylor
                                  Product  Manager  (25.)
                                  Fungicide-Herbicide  Branch
                                  Registration  Division (H7505C1

-------
        /fl/*y  I  _ ~li&	  SENDER'
PLEASE ADVISE BY FACSIMILE OR PHONE IF MESSAGE  IS  NOT LEGIBLE OR  ALL  PAGES
ARE NOT  RECEIVED.


FACSIMILE NO,  ISi
DIRECT  LINE TO TELECOMMUNICATIONS  OPERATOR IS 919-5
-------
 RHONE-POULENC
BHdNE-POULENC AQ COMPANY

                                                          May 1. 1989
     Robert  Taylor  .
     Environmental  Protection  Agency
     Office of Pesticide  Programs
     Crystal  Mall,  Building  2
     Arlington,  Virginia    22202
     Dear Mr.  Taylor:
           SUBJECT.    Buctril  (264-437),  Bronatc  (264-438)
                       Buctnl  +  Atrazine  (264-477)

           Rh6ne-Poulenc Ag  Company hereby applies  to  conditionally
     amend pursuant to FIFRA 3 (c) (7) (a)  the pesticide product
     referenced  above  to incorporate the  revised labeling, new
     classification for  restricted use,  additional claims,  and specific
     conditions  for continued registration set forth below.  Rh6ne  Poulcnc
     hereby claims in  connection with  this application  for a-nencc.
     registration that it will .conform  to the following conditions  as  cart  of
     its distribution and sale of these products.

           The  text for stickers  which incorporates  new language adding a
     classification for  restricted use,  a  new label warning  concerning. .
     developmental  toxicity, and  specific use  directions requiring
     additional  protective clothing and  equipment  and  new  use practices
     is appended to this Application  as Attachment  A. . Rhone Poulcnc
     agrees as a condition of  registration  that  it will 'attach the  stickers
     appended to  this  Application as  Attachment A  to- all  containers of
     these  products that are  released for shipment   by  Rhone-Poulenc
     after the date of approval of this amendment by  EPA.    Rhdne
     Poulenc further  agrees  as a condition of  registration  that  it will
                  97700

NTEW*TiO*Al. TELEX NUMBEB B*CX *PC IOC

-------
                     CONDITIONAL  REGISTRATION


I.Revised Labeling
     A. Wh a t
          1. Classification
          2.Warning Label
          3.New use pracices
     B.How
          1.Stickers
               a.All  stocks leaving RP after 5/5/89
               b.All  stocks leaving distributors after 5/15/89
                    (1) ins-tructions
                    '(2)enough for all  inventory by 5/25/89
          2.New permanent  labels
               a.Plan by 5/22/89
               b.On products by 10/1/89
               c.states:
                    (l)deletes claims  for turf and non-crop uses
                    (2)all restickering provisions
                    (3)equipment needs

11.User  Training
     A.Training of users
          1.prior  to  1990  spring use
          2.pending EPA  approval
     8.Hard-coup!ing  transfer systems
          1.program to assist users not owning such system
          2.plan by 10/1/89

III .Repackagi ng
     A.Hard-coupling  for all bulk (>30 gal) by 10/1/89
     B.Feasibi1ity study for small  containers by 1/1/90

IV.Safety assessment  data
     A.Rabbit  dermal  Tox--5/l/90
     B.Male repro--6/l/90
     C.Worker  exposure--12/31/90

-------
RHONE-POULENC
RH6NE-POULENC AQ COMPANY
     provide  to  each distributor holding  inventory of  these  products
     quantities of  these  stickers sufficient for  such inventory  within  ten
     days after the date  of approval of this  amendment by EPA,  and that
     Rhdne Poulenc  will  assume  responsibility  for insuring  that  each
     distributor attaches  the sticker  to  each container  of  these products
     which  are sold or distributed  by the distributor after the date  the
     stickers are received.   Rhdne Poulenc further agrees as  a  condition of
     registration  that  it will provide  to each reseller and  retailer holding
     inventory of  these products  quantities of  this sticker  sufficient for
     such inventory  within  twenty days  after the  date  of  approval  of  this
     amendment  by EPA, and that  Rhdne Poulenc  will  assume
     responsibility  for insuring that  each  such  reseller  or  retailer attaches
     the slicker  to each  container  which  is sold or distributed  by the
     reseller or retailer after  the  date the stickers are  received.   Rhone
     Poulenc  further agrees as  a condition of registration  that  it  will
     provide to  each  distributor, reseller, and  retailer along  with such
     stickers  the information  package and  the  instructions concerning  the
     manner in which  the  sticker must  be affixed to each container  of
     these  products which  are  appended  to  this  application  as Attachment
     B.  Rhdne  Poulenc  further agrees as a  condition of registration that it
     will  implement the communication plan appended to this application
     as Attachment C  in  the  manner and by the  dates  described  therein.

           Rhone-Poulenc further agrees  as  a  condition of registration  that
     it  will submit by  May 22, 1989 a complete  copy of revised labeling
     for subject  products  which (1)  deletes all  claims,  references, and  use
     directions pertaining to  the  previously  permissible uses for  turf and
     nOn-crop  areas,  (2)   includes  all the  new  label provisions included in
     the sticker  which is appended to this  application  as  Attachment  A,
     and (3)  incorporates  the  additiona!  revised  labeling  concerning the
     equipment. which must be  used  for mixing and loading as set forth in
     Attachment  D. . Rhone-Poulenc  -agrees  as  a condition of registration
     that, after review and  approval by EPA of  the complete revised
     labeling  to  be submitted by  May 22, 1989,  such revised labeling  will
     be attached  to each  container of these  products which  are  released
     for shipment  by Rhone-Poulenc  after October 1, 1989.

           Rhdne Poulenc  further agrees  as  a  condition of registration that
     it  will develop and  submit to EPA by October 1,  1989  a proposed
   S0 2030
        - TELE* NUMB^M 4W937H-
               IO*. 9VICS TClCX NJMOCD 9W3- AMCWCP3ACK APC IDS

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ff RHONE-POULENC
    RH6NE POULENC AO COMPANY
          program  to  provide additional  training to users of  bromoxynil
          products  prior to  the-1990 spring use  season,  and  will  upon  approval
          by EPA  implement such a training  program.   Rhone-Poulcnc  further
          agrees us a  condition  of  registration  thai  it will by  October  1,  1989
          establish  a  program to provide assistance to users  who do not  own a
          mechanical   transfer system  which  terminates  in a  drip-free hard
          coupling  (the  type required for  30 gallon drums in  the  labeling which
          must appear on  containers  after October  1,  1989)  and  who  wish
          either to obtain  such  a  system  or to  modify their present system.
          Rhone-Poulenc further agrees  as a condition of registration  that  it
          will  thoroughly  investigate the  feasibility of packaging these
          products  in  containers which   are smaller than  30  gallons  and  which
          include a hard coupling  designed for use with  a specific closed  mixing
          and loading  system, and  will  provide to EPA a detailed  report of its
          findings and conclusions  no later than  January  1, 1990.  For products
          sold  in bulk containers:  Rhone-Poulenc  hereby applies  to  amend  its
          registration  for these  products  to provide, and  agrees as a  condition
          of registration, that all bulk  containers of  these products  which are
          released for shipment by Rhone-Poulenc  after  October  1.  1989  will
          include a. mechanical  transfer  mechanism which terminates  in a drip-
          free hard coupling which may  be  used only with a  spray or mix tank
          which has been  fitted with a compatible coupling.

               For each of the specific data requirements described  below,
          Rhdne Poulenc agrees as a condition of registration  that it will
          develop  and submit' the  specified  data according to  the specified
          schedule.  Rhdne  Poulenc agrees that  failure to submit the  required
          data, or to  adhere  to  any element of  the specified schedule  for
          development and  submission  of the data, will  constitute grounds  for
          cancellation  of this registration under  FIFRA $  6(e),  unless  Rhdne
          Poulenc  demonstrates  that it  has undertaken in  good faith and in  a
          timely manner all  steps  necessary to  develop  and  submit the  data
          according to Uie  specified schedule  and that its failure to submit  the
          data or to adhere  to  the  schedule  was  due  to factors that could not
          reasonably have been within  its control.
         Rabbit  Dermal Teratology  Study
     *O BO* 1JOM J *
     aiSIABCMlRH
     (010) 540-333S
             . TG.EXN
                  K.CS 9ERVICC3

-------
f[  RH6NE-POULENC
    RH6NE-POULENC AQ COMPANY

         Pilot:
              Submit  Protocol-May 8,  1989
              EPA  Approval of Protocol by--May 23, 1989
              Study InitiationMay 31,  1989
              Study Completed-September  1,  1989
              Final Report-October 16, 1989

         Full:
              Submit  Protocol-June 1,  1989 (without dose  selection)
              EPA  Approval of Protocol by-July 15,  1989
              Discussion of Dose Selection-October 2,  1989
              EPA  Approval of Dose Selection by-October 23,  1989
              Study InitiationNovember  1, 1989
              Study Completed-March  I,  1990   '
              Final Report -May 1.  1990
         Male Reproduction  Effects Study

         Pilot:
              Submit  Protocol  -June  15,  1989
              EPA Approval of Protocol "by-July  3, 1989
              Study  Initiation-July  14, 1989
              Study  Completed-September  1,  1989
              Final  Report-October  2,  1989

         Full:
              Submit  Protocol-July  3,  1989 (without  dose selection)
              EPA Approval of Protocol by-August 4, 1989
              Discussion of Dose  Selection-October 2,  1989
              EPA Approval of Dose Selection-October 14,  1989
              Study  Initiation--November  1,  1989
              In-Life  CompletedFebruary  1,  1990
              Final  report-June I.  1990


         Worker Exposure  Study

         Submit ProtocolJune  15, 1989
    RESE *O TB.ANGie BkAK MC 27700
    INTERNATIONAL UL* NUM8f C IDS

-------
ff RHONE-POULENC
    RHONE-POUtiNC AQ COMPANY

         (Protocol  is to be  based on scope  of  study  as  presented in Attachment
         E)
         EPA Approval of  Protocol -August  18,  1989
         Draft Report  (Non- QA'd.)--November  15, 1990
         Final Report-December  31.  1990
         The  schedules given above are based  on Rhone Poulenc's  expectation
         that  EPA will respond  to  the protocols  and dose selection in a  timely
         manner.   If EPA does  not provide a  full response  to  a  proposed
         protocol  or  proposed dose  selection by  the date  specified for EPA
         approval, the  agreed schedule  may be  adjusted  to permit an equal
         delay in  completion of subsequent steps.  However,  if  EPA  responds
         in a timely manner but is unable  to  approve a proposed protocol  or
         proposed  dose selection by the specified  date due to  substantive
         concerns  regarding  the content  of  the  proposal,  Rhonc-Poulcnc agrees
         that  it will  adhere  to the  established schedule unless EPA  approves
         an  extension.

         Rhone-Poulenc will submit one-line  status reports on each  of the
         required  studies on at  least'a quarterly basis.  The  proposed protocol
         for the  Worker  Exposure  Study- will  also describe and  require
         submission  of appropriate  interim reports.   In  addition to  submission
         of these  reports, Rhone-Poulenc will  immediately notify EPA if any
         problems  arise which might  prevent  the timely  completion  or
         submission  of any of the  required  studies.

               Rhone Poulenc acknowledges that  this  ..pplic .tion fir
         conditional  amendment is  based on  the Agency's  assessment of the
         data  concerning the risks  and  benefits  of bromoxynil use available  to
         EPA as of the dale of  this application.   Rhone Poulenc  declares  that  it
         is  Rhdne Poulenc's present intention  not  to  request additional
         amendments of  this  registration during the  time  required  to develop
         and submit  the  data described  above.  Rhdne Poulenc  specifically
         agrees that  EPA may deny without  hearing  any  additional  application
         to  amend this registration  which Rhdne  Poulenc  may  submit during
         the time  required  to develop and  submit  the data required  above, if:
         (1) EPA   determines  that  Rhone-Poulenc has  not  submitted
         substantial new evidence  which materially changes  the  Agency's
     cs:*nCM TRIANGLE WX NC 37709
    (9l9lS4?000
         IONAL TELEX NUM3CB 40M3?I ANSWERBACK PC OTP
              OTH-OUTJON SCrtVlCCS T6k* NjMBtBaOOOS.'J-AKBlMiMQtt.* "C IOC

-------
//?r RHONE-POULENC
      RHdNE-POULENC AO COMPANY

           assessment of the risks and benefits  of use of bromoxynil  and which
           was not  available to cither EPA  or Rhone-Poulcnc at the time this
           application was  submitted and   (2)  EPA provides a written
           explanation  of the  basis for its  determination.
           Sincerely,.
           Nick Somma
           Registration  Manager
           COPY; Mr. Edwin Tinswonh
      AE6CABCMTOlANGl.rataK.NC 27700
      <9tl59-?000
      INTe^NATlONAC O'STBlS JTION SC^VlCCS ?t..C* NJMOCP *VHV> ANSWCnOATK APC O3

-------
                                  Unuc $(*
                                                 9lOO-rr> (TS
                                                  OC 2040
                         Application for Psticid0: U Registration
                           Kr	LxAmendment
                                                                                102852
t Company/Product Number
       364-477
                       12. Daw
                                             Section
                             May  1.  1989
Product Mnag*r
  Robert Taylor
4. PropOMO Qtll <

     ...* FT!,'
S N*m* artI Aa<3
-------
RHONE-fOUL,ENC  AG  COMPANY




BROMOXYKIL SPECIAL LABELING COMMUNICATION PLAN
09:20;38A
Nay 1, 1989
COMMUNICATION
MEDIA
FAX
DIRECT MAIL
PERSONAL CONTACTS
STICKER PBRSONAL
DELIVERY
DATA-LINE
RADIO
POINT OP PURCHASE
INFORMATION
DI 66 EMI MATED
RESTRICTIONS/
USE DIRECTIONS
RESTRICTIONS/
USE DIRECTIONS
V
RESTRICTIONS/
USE DIRECTIONS
V
PACKAGE STICKERS
RESTRICTIONS/
USB DIRECTIONS
RESTRICTIONS
(SEE DEALER FOR
FURTHER INFORMATION)
RESTRICTIONS/
USB DIRECTIONS
TARGET
AUDIENCE
DISTRIBUTORS/
RPAC SALES/FD
DISTRIBUTORS
RESELLER/CUST APPLTR
UNIVERSITY EXTENSION
GROWERS { RESELLER HAIL)
UNIVERSITY EXTENSION -
NEED SCIENTISTS
RESELLERS
CONSULTANTS/FARM NGRS
DISTRIBUTORS
RESELLERS
GRONERS
GROWERS
GROWERS (VI A RESELLERS
PLACE OF BUSINESS)
ESTIMATED NO.
INDIVIDUALS
160
169
50
6,000
4,000
5,000
100
3,000
100
160
2,000
35,000
143,000
40,000
DELIVERY
TINE FRANK
DAY 2
DAY 5
1
V
WEEK 3
WEEK 1
WEEK 1 - 1,500
WEEK 2 - 1,500
WEEK 2
WEBK 1-2
WEEK 2-3
WEEK 3
WEEK 3
WEBK 2-3
TOTAL NUMBER CONTACTS: 238,739

-------
                                               -it*. B,3|.C:.= - ,
                                       WaahinglO". DC
Application for Pesticide:
                                                     _  Registration
                                                     J Amendment
                                                    10283
i Cofipany/*odu0i
      Z64-438
2 Oatt
                                           flaeilon
    May 1,  1989
S Nam* ana JkJO'tw o< Applicant (ineiuot Z/f Cew;
'Product Managar
   Robert Taylor
                                                   j  i
|  | Qh
                             Rhone-Poulenc Ag Company
                             P. 0. Box 12014. Z T. W. Alexander  Drive
                             Research Triangle Park. NC  27709
             Bronate Herbiddt
                                Section II - Amndmnt Information
                                                                           May 1. 1?89
         LaDel modification to Include Restricted Use Classification and additional
         label restrictions.
S.dlon III
i . Malarial Tnii Product win 0a Pac*a0ed in
C'u'd-Aoaiiiani Packaging, unit Packaging
riv*. 'PINO
(JJve, QNO V.-
Unit pariiaj* wgt No. per oantaJnar
Watai -Soluble Pacoaging
riv*. riNo
 tea.'
Paohag* w*flhi NO. per eontainar
J Location of Nat Content* lrfo
-------
                                           o> P*tie.d Pr
                                            WaaMngion.
                                                    i Ptotc*'On
                                                    'Ti (TS 767
                                                     2O*0
   __  ^^ _
   1^ FR/X      Application for Pesticide:     Registration
    .T LB!  r\       KK                            ULJ Amendment
                                                                                    102850
1 Company/Product NumOor
         264-437
                         2 Daw
                          May  1. 1989
                                               jLaaifln
iy_
37<
Piodud Mangt
 Robert Taylor
4rzT"c
5 Nam* and Addcw of Applicant (Inch** ZIP GOd*J
                                Rhont-Poulenc Ag  Company
                                P.  0. Box  12014,  2 T.  W. Alexander  Drive
                                Research Triangle Park.  NC  27709
             it  nw
                                    Sod Ion II - AfT^ondfnant fln^qfrpatlon
  8wbj*et

            i Aamna*
                          f"| Final pHntod labl
                          1   llnraiDani* uTAaa
                                             nev IMMr
                           Data of v*mr

                           Mav  1.  1989
         Label  modification to  Include  Restricted Use Classification and additional
         label  restrictions.
                                               Section ML
v MatnaiTni Product win 90 Paeafl*d m
 Location of Not Conttnt* mformation
                            Unit Paokaglng
                            HToa.*
                            UnH paokago gi  No. p*> oontalnoi
                                                     Watof*8o((s) of ftoUH  enuinar
                                                                                   2. Typo of Contain*!
                                                                                        Motal
                               Qiaa*
                               Papor
                               Oth* (Specify)
 . Location of Ubi
                                       6 Mannor In \n*teh lab*! to Affixed To Product
_ ,
   J
~
   | On matrlal oaompny1ng product
                                      f^J'*
                                      J    ] dM
                                               ftaailan IV
      N1ck Somma
      Registration  Manager
                                                     Taiapnona No. (toclvd* A/o Cod*/'
                                                       919-549-2372
I oartffy that the Maiamentt I ha*o mad* en tni form and an naehmonta tftoroto an true, aoaura
oempioto. I aoknowiodge tftti any knowingly falaa or misleading Matamonl may b* pwnlthabi* by
Imprlaonmant o both undo' applicable law
                                                                           Una or
                                                        9. Tltto
4. T
          /-     / '
          Nick   Somna
                                                          Registration Manager
. Oat* Signod
  May  1. 1989
                                                                                     Dai*
 PA f **m

-------
ATTACHMENT  A

-------
                                                                          - CJ '
                   RESTRICTED  USE  PESTICIDE
    for r*jul Mfe to nd UM anty by
                                                        wo scc'vc,on and ony far thos* U
                                S* precautionary tm"nnu tor ta*tofu tfm product  cUst/iad Racrtaad Uta
 BUCTRIL*  HERBICIDE
                Or
           tar e( brereayn
NERTNQFED&JTBc. ........ ...... .
                           dte
                                   hyt
.33.4%
 80.8%
Bramexynll actenoat* *jqu>vtooi to 22% of bromoiynll or not b)M than
 ID pounds ef bramorynll p*r gallon.               	
                       KEEP OUT OF REACH OF CHILDREN
                              AVISO   WARNING
PRECAUTION AL U5UAHIO: S uta no
                                      , no u* * pfoqucte n
                                                               Uqu>u txy Mo xpltexx> rnp>m)nt+
C.F.A. H*>q. No. 264-437
                                                I*HB*,II* ci i .jce in ?.
                                         *m*tl*n OILY Oil t Miu'V A 0y 1-4O
M(CAUT10MAT
      TO NUMANt AMO OOMtiTJO
WAIIMHQ . IITNCttO utl
                         AMMAU
                                                    OUKIHO AIWAL
*** HtUB

      Ml
     AMM
 i M*te>t MANOXINQ Twic oowcs ixmrt MUSI otatnvt
M IMC Th* oBonoHi MI la " on
(VO*. * K^II '(Afl > |*
oowvrmgt. or eooa   iwv yM  *CI*IMI (lot
                          !>< *KM W icng atnt Wow OMW
                                   im.il *>IM*M > *
                                   lor rt mttJna, on* loM|
 M B'M.a k ii*ai In  30 9*0* *vr* a>  > nM  MUI *f M fMtov > - >

      m*i wtxf 1 "er^rie*' imltt iftm. ao net 
AU. C*ONft A^^irMQ THia M*OOUCT. OH IMINC OB CUAMINQ
USC3 WITH TUB PflOOuCT. UUI OVKA
                                       CIMT i* I*
                 ft* 9f P*W*WB ^*)flp*^*j ^ 4
                nrafi *ii.ina  CJP i
                                                                      (K.)
                                                                                rt  rofeM JTW.. in nOo.o
                                                                                 !  ira*nili M( i.g . norm*
                                                    OCNUUk
                                                        TAjm MI
                                                                        v >, t * 
                                                                                          in** ' auuii* e<
                                                                         0* Ml
                                                                        *en u*
                                                         rwT 0* MAOKOAl TUCAfMtMt

                                                    If rAllOWOi Oft MMHAi M*nu*  O*  UM>
                                                    dilUaMi 0* Na g*> vMn

                                                    W ON MM: W*>n > pftjrty al * in* ** 0*1 rrvdUu n*rix> I Mrwn p*nu

                                                    V III ffTtt: Ru* M  W It mm/N a* m**Kl MUflMH

                                                    tVIOHMMTAl MAT A HO*
                                                    TMi pBMCJO*  VIC   tM fB"  CM* * OB)* Ml*x BfXfl > MM* l'*8u"t Of
                                                    HMD* > MlMaj"! 10 f7 D0*> * '. DO HOI pn; 9I* W **' PO net (BBIp *"
                                                    **Mffi aandUan* )** <1 (>m tfrg*i /* Oe nei ORH umnal* wi*< Or oninj a
                                                    M4VSICAI 1MO CMtHCAL NAZAWt
                                                    0* *> MM > ! > N**l o> on*n Itan*
                                                            roa utc -te* imciMtf MI
                                                    IT IS A MOIATIOH 0 nOHAt CAW TO U IMS rPJOOUCT IM A MAHHCR
                                                    MCOMI1(NT WITH IT UkHUNC.
                mi  *jf r *

                   < to don* by <<
                                                     IOHAOE AND
                                                    Do *a
                                                                      <* bv dortg* or
                                                    W*1M* 'Munnf Mm tta  IMi tntfua ma to oo* al *n  >
      alia
        . 1 T W N*M*

-------
                   RESTRICTED  USE  PESTICIDE
 BUCTRIL** Atrazine Herbicide
 POSTEMERCENT HERBICIDE FOR CONTROL OF CERTAIN  BROADLEAF WEEDS IN CORN AND
 90RGHUM.	
 ACTIVE INOED1B*T
   OoUnob otd
  gallon.
  "Pradua oorttJnt ZO pounofc of oftsina par gafan
                                           erT*y^
                                                                                           T5.74%
                                                                                           Si.er*.
                                                                                          ..62.04%
                       KEEP OUT OF REACH OF CHILDREN
                                         CAUTION
                      	SHAKE WELL BEFORE  USING	
 EPA Hg. No.
                                                                                     No.
                               ror PRODUCT uoe inwrmaiwn ecu i ra
                           EMf RCNCY totomMtton ONLY Ckll 24 Hour* A Dcy 140O494-7577
           TATfMMr

HAJAMO* TO MUMAM AMD oontnc AMMAL*
WAHMMO  MSTftCTtO Utt
U  M WMliM! mr 0 Mt>4*tf> M
lloo OMB IKOOT lo
                                                    OUMIHO AXMAI.
                      ol*t* Mi lofcoroiory tn
                                        I* M*
                                           Wi
OCMCMAI. MOUMfM(NT fOd AU UM
     If Ml
     Awl

UMn  > o/o*wc< AM
AMMK
Mute
                   (Mggh ln or
                     10
                  AW UAO 0> IMi
                                   com*  . r* cr
                                                         WONR.
                                                                                             ji cio? (
                                                                                    Mr
                                                    TMi
                                                            tOBC I*
* * 0>Wuei 
* praouci pv
              m * a gwon um  f w
              "wtt UM
                                  ul  
                4M * OM > Of* **>
                      0* "" *M>r di>*a% u> . 0 ' . IMM

         I A MMC HAH A I
                 10 1M
                MAMMA twa
                M)lnf tram A
          MMUMkOVI
                              m m mm* MJABJIII A>
                              to A o. To om COTAI
 MM1 Of AMh; IM *Mci Ah * 4A*r " **" W * "" H> V *
                                           tN
 HAW at* (irnxn Wm* "I1 H
   ill ) '
                                                   TOIU01	

                                                   0* ow 'ooiilon >ooo*. *  IOJTWOJOUMO oio l?"r. * o^ooa 10 ('otmg
                                                   I01HJOIOXOA. N l*fll>MO> aM AS* ' (  hOUtl  VMi<
                                                    rtvncmt oitOMi
                                                             torn  WM ot Mi
                                                    Moiol
                                                                                            * AM OOM*
                                                                       o> I AIBIM* or 6u **> Local wihoil
JO Mf
KlM)0
         .Tw
                                                    I
                                                          A
             NMk CAMAM

-------
                    RESTRICTED USE  PESTICIDE"
    Por ruJ
                                              iUlemots fc-
                                                                            tnos* u*s covoroo by
                                                                                'UaiJ Us*.
 B RON ATE" Herbicide
rOH CONTROL Or CEHTAJN oMvjAUUbAr
ACTIVE INGREDIENT
    Oewnole c*d *ur of bromoiynll* O.S-dlbromo I hydf
    booctyl***

INERT NQREOIENTS;
                    aton>  ?1 9% of taemcuynl or *oc IMC ih*n 2.0 pound* d
            VQ% 2-rntf>U*BjiaJi ij> aortic acd o> ntf laaajtw 2 3om.ndB MCPA add p*
                        KEEP OUT OF REACH OF CHILDREN
                                         WARNING
EPA Rag. No.
                                                                                fePA Ut NO.
                                POT PHOOUCT USE information cii
                         EOT BmgftCENCY Information Qf^L,Y Call 2* Hours A Day 1 -800-334.7877
            T4TCIMMT*
                          AMMftlt
HAZAMOI TO MUUAMt AMD w_..... _^._v>                      .,..
WABMIMB . CITBICTtQ UM                                   OVIWIHa
U .. . rc.uci m.;  ".^.. IB , HBBltt..  CWBIU^ t. M. p^luc.   ^T J^t SIrJLf "I?,""1 ""*' *" '" * **"*' *" w 
tttt kBn B I* (BUB*  Bli  BICCU Ml MB'*IB'T nlinl.  WBIHBA    <.HBIBW. t"BB( ). BI
         **   pMIvlnr wl * !> 0* A* < V '  MXU>^^*) f'9>
                                                                   i ii tAi <*> IA* *'0i*cii> aotning

                                                      TATCHIKT Of MACnCAL TOC4TMCHT

                                                      If (WAUOWCO:  4*i "' !(. 0* ' !<
                                                      ^ul*w Oe na |k 4y to v KMcftoaeu* pw
                                                      V ON tWI*: *i win ouniv    '  0 "WOC* tncnian i niiiian
                                                      If I" ITU: *V   !>
m aradua px Mf. ru
                           . r. KWMM  nut oi 10 |ion > rrmn 
                                                                            Ui oix CM*
                                                                            Oa >w e*r "
                                                                 !> dfll' (torn urgpi vMi OB "*
*>>*> 14Mb
                TMIJ OOUCT


        UUI Odurl Iram 
                                                                                              0* 
                                       minnnin 
                                  Mr. T
                                i to tram >*" *  e* >
        r (Ml
                                                      ITOBAQI AND WI'OIAL
                                                      TOMOt
                                                      OB * dM
                                                      f. iBMMI
                                                                    tew e>
                                                                                                   r
                                                          fB*jHg Dem o* UBB el Mi oratfwa mey  * * en * o>  in
                                                                        i 
                                                      COMTAIMH Ol0Al
                                                          tat ** < 
                                                                                              0 Owning 
                     i  * By  i
MMBMMk> I KM
-------
ATTACHMENT  

-------
                  BROHOXYNIL CONTAINER RCLABCL'NG SCHCDULL
FOLLOWING  IS A DETAILED PLAN DESIGNED 70 APPROPRIATELY RELABEL ALL BROMOXYNIL
PRODUCT CONTAINERS EXISTING WITHIN THE CHANNELS Op TRADE. INCLUDING
RHONE-POULENC, DISTRIBUTOR- AND DEALER INVENTORIES, IN A TIMCFRAME CONSISTENT
WITH THE APPLICATION FOR AMENDED REGISTRATION.  UPON FINAL EPA APPROVAL
THESE STEPS WILL IMMEDIATELY BE IMPLEMENTED:
DAY 1 FOLLOWING. EPA AMENDED REGISTRATION APPROVAL

RHONE-POULENC WILL INITIATE THE PRINTING OF APPROVED AMENDED LABELS
FOR BUCTRIL*. BUCTRIL* * ATRAZINE AND BRONATE* HERBICIDES IN SUFFICIENT
QUANTITIES TO RELABEL ALL EXISTING BROMOXYNIL CONTAINERS HELD BY RPAC,
DISTRIBUTORS AND RETAILERS, .AS HELL AS FUTURE PRODUCTION QUANTITIES
SCHEDULED FOR THE REMAINDER OF 1969 USE SEASON.

RPAC HILL IMMEDIATELY HALT SHIPMENT OF ALL BROMOXYNIL PRODUCTS UNTIL
APPROVED AMENDED LABELS CAN BE PRINTED AND AFFIXED TO EACH CONTAINER
HITHIN RPAC POSSESSION/IN A MANNER CONSISTENT HITH THE "RELABELING
PROCEDURES" OUTLINED IK ATTACHMENT A.
DAY 4-10 FOLLOWING EPA AMENDED REGISTRATION APPROVAL

REVISED LABELS HILL BE DELIVERED AND STICKERING OF RPAC INVENTORIES
AT PLANTS AND WAREHOUSES HILL BEGIN.  NEWLY L .* E 11  IKIU '  W II BE
RELEASED FOR SHIPMENT TO DISTRIBUTORS.

ADEQUATE QUANTITIES OF EACH APPROPRIATE LABEL, ACCOMPANIED HITH "RELABELING
PROCEDURES", WILL BE SHIPPED TO RPAC FIELD SALES REPRESENTATIVES FOR
IMMEDIATE DELIVERY TO DISTRIBUTOR WAREHOUSE LOCATIONS WHERE BROMOXYNIL
INVENTORIES EXIST OR HILL BE DIRECTLY MAILED TO DISTRIBUTOR LOCATIONS.
APPROPRIATE COMPENSATION FEES HILL BE PAID TO DISTRIBUTOR FOR RELABELING.
AND VERIFICATION OF LABEL DELIVERY WILL BE MADE BY DISTRIBUTOR SIGNING
THE "RP LABELING COMPENSATION" FORM.  MONITORING BY RPAC FIELD REPS
HILL BE PERFORMED TO INSURE COMPLIANCE.  DISTRIBUTORS WILL BE INFORMED
THAT NO BROMOXYNIL PRODUCTS MAY BE SHIPPED PRIOR TO RELABELLING ONCE
LABELS ARE RECEIVED.

-------
                BRONATE*/BUCTRIL*/BUCTRIL* * ATRAZ1NE
                   RELABELING COMPENSATION PROGRAM

 THIS PROGRAM  IS  DESIGNED  TO  COMPENSATE THE DISTRIBUTOR AND RESELLER
 FOR RELABELING' HIS CURRENT  INVENTORIES OF BRONATE*, BUCTRIL* AND/OR
 BUCTRJL** ATRAZINE  BROADLEAF HERBICIDES TO COMPLY WITH EPA REQUIREMENT!

 TO PERFORM THIS  TASK  IN ACCORDANCE WITH SPECIFIED 'RELABELING DIRECTIONS,
 DISTRIBUTOR/RESELLER  WILL BE COMPENSATED AT A RATE OF $0.50 PER
 CARTON, 30-GALLON DRUM, OR  110-GALLON fllN-I-BULK CONTAINER.

 CURRENT PHYSICAL INVENTORY  AS OF 	
                                        (DATE)

               BRONATE'*   BUCTRIL*    BUCTRlL* * ATRA7JNE
CASES
DRUMS
MINI'S
I HEREIN CITIFY THAT AS OF DATE SPECIFIED ABOVE, WE HAD IN OUR
INVENTORY THE QUANTITIES OF RHONE-POULENC BROMOXYNIL PRODUCTS
AS LISTED Au'OVE, AND HAVE RECEIVED ADEQUATE QUANTITIES OF REVISED
LABELS FOR RELABELING ABOVE INVENTORIES.
BUSINESS NAME:

STREET ADDRESS:
CITY: 	 COUNTY: _____ STATE: 	 ZIP
OWNER/MANAGER:         	                  PHONE:
                       tSJoNAlURfc)
RHONE-POULENC REPRESENTATIVE:
                                    (SIGNATURE;          TtRR

-------
DAY 11-20 FOLLOWING  EPA  AMENDED REGISTRATION APPROVAL

FIELD REPRESENTATIVES WILL  INITIATE DELIVERY OF APPROPRIATE LABELS TO
EACH ACTIVELY SELLING BROMOXYNIL RESELLER. BEGINNING FIRST WITH PRIORITY
ACCOUNTS WHERE  LARGE INVENTORIES ARE KNOWN TO EXIST. INSTRUCTIONS FOR
PROPER RELABELING WILL BE" PROVIDED AND COMPENSATION MADE TO INSURE COMPLIANCE,
RESEl-uRS WILL  BE INFORMED  THAT NO BROMOXYNIL MAYBE SOLD PRIOR TO RELABELLING
ONCE uABELS ARE RECEIVED.   RETAILERS WILL BE SUPPLIED WITH ADEQUATE
NUMBER OF LABELS TO  PROVIDE TO GROWERS.  VERIFICATION OF LABEL DELIVERY
WILL BE MADE BY RESELLER SIGNING THE "RELABELING COMPENSATION" FORM.

EFFORTS TO HAND DELIVER  NEW LABELS TO ALL RETAILERS WITH BROMOXYNIL
INVENTORIES WILL BE MADE. HOWEVER. MAILINGS TO MINOR BUSINESSES MAY
OCCUR TO INSURE DELIVERY IN TIMELY MANNER.  THESE MAILINGS WILL BE DONE
USING REGISTERED MAIL TO VERIFY LABEL DELIVERY.
DAT 20 FOLLOWING EPA AMENDED REGISTRATION APPROVAL

LABEL DELIVERY FOR BROMOXYNIL FIELD INVENTORIES WILL BE COMPLETE AND
MONITORING BY RPAC FIELD REPRESENTATIVES WILL CONTINUE, TO.INSURE ALL
CONTAINERS PROPERLY LABELED FOR SALE.

-------
                                ATTACHMENT A

                  BUCTRIL*. BUCTRIL*  ATRAZ1NE. BROHATE*
                            RE LAB CLING PRXLDURE
2*-6ALLOH JUG

1.  DEPALLETIZE CARTONS (36 PER PALLET).

2.  USING THIN. FLAT METAL BAR. OPEN THE CARTON BY SLIDING BAR UNDER
    TOP FLAPS FROM MIDDLE OF CARTON TOWARDS END OF CARTON.  USE BAR
    TO BREAK CLUE SEALANT ON BOTH FLAPS BEING CARFUL NOT TO DAMAGE FLAPS.

3.  REMOVE HI TRUE GLOVES AND SET ASIDE.

4.  REMOVE BOTH JUGS FROM CARTON.

5.  REMOVE THE PRODUCT BOOKLET FROM THE LABEL ON SIDE OF JUG. ROLL BOOKLET
    AND PLACE INTO HANDLE HOLE OF JUG.

6.  PEEL BACKING FROM NEW PRODUCT LABEL AND PLACE NEW LABEL COMPLETELY
    OVER EXISTING LABEL ON THE JUG.

7.  RETURN JUGS TO CARTON AND REPLACE GLOVES ON TOP OF JUGS.

6.  FOLD DOWN THE TWO SMALL FLAPS OF CARTON AND FOLLOW WITH TWO LARGE
    i-LAPS.

9.  TAPE CARTON CLOSED WITH COLORED PACKING TAPE CENTERING ALONG THE
    CARTON OPENING AND EXTENDED DOWN BOTH SIDES 2-3 INCHES.

10. REPALLET1ZE CARTONS IF NECESSARY INCLUDING RESTRETCH WRAPPING IF
    AVAILABLE.


30-6ALLOM DRUM AMD 110-GALLOH MINI-BULK

PEEL BACKING FROM NEW PRODUCT LABEL AND POSITION NEW LABEL OVER THE
EXISTING LABEL ON EITHER THE 30-GALLON DRUM OR 110 MINI-BULK CONTAINER.

-------
ATTACHMENT  C

-------
ff RH<5NE-POULENC
    HdNi.POULENC AO COMPANY


    OFFICE MEMORANDUM


     TO:     Nick Somma                    DATE:    M*y J.  i9B9

     FROM:   Dave Downing


         Please find attached the Bromoxynll  Label  Amendment Communication
     Plan.  Our goal'1s to reach all persons  who sell* apply or  recommend
     bromoxynll products within the agricultural community  In an orderly,
     logical and timely manner.  With this In mind, we plan to first  communicate
     new restrictions the day following EPA approval to all RPAC Field  and
     Office Personnel  involved with the sale, promotion,  development, field
     testing and distribution of bromoxynll products.  By the second  day
     all bromoxynll product distributors will be contacted  with  this  Information
     via overnight mall.  All resellers, university extension personnel and
     weed scientists will have bromoxynll label  restrictions direct mailed
     to them within the first week  following  EPA approval of copy.

         In addition to written communication, distributors, resellers, university
     extension personnel and weed scientists  will be personally  contacted
     by our field representatives within 2 weeks of EPA approval.  Resellers
     will be contacted on a priority basis according to their past sales
     volumes as recorded by RhSne-Poulenc.

         Following these written and personal contacts, with those who will
     be called upon to provide Information, mass communication to growers,
     crop consultants  and farm managers will  begin  via radio spots, data-line
     Information system, and point  of purchase posters.. Informing them of
     the new "Restricted Use" classification  for bromoxynil  products  and
     to contact their local reseller for detailed information.

         Rhone-Poulenc feels that this coranunication plan will serve  the
     Intended need to  alert the agricultural  Industry of  the proper manner
     to handle and apply bromoxynil  products  with minimal risk during the
     1989 use season.
     DPD:vwg
     Attachment
     cc:      J.N.  Harton
             S.A.  Schmotzer

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                BROHOXYNIL  LABEL AMENDMENT COMMUNICATION PLAN
UPON RECEIVING FINAL APPR'OVAL FROM THE EPA OF 1989 LABEL AMENDMENTS
FOR COMMERCIAL BROMOXYNJL OCTANOATE FORMULATIONS, AND APPROVED COPY
OF INTENDED INDUSTRY COMMUNICATIONS. RPAC WILL IMMEDIATELY INITIATE
A COMPREHENSIVE PLAN TO DISSEMINATE NEW PRODUCT PRECAUTIONS AND RESTRICTIONS
TO APPROPRIATE AUDIENCES WITHIN THE PESTICIDE CUSTOMER/USER NETWORK.
FOLLOWING IS A DETAILED DESCRIPTION AND TIMETABLE OF HOW THAT PLAN WILL
UNFOLD:
PAY 1 FOLLOWING CPA APPROVAL OP COPY

COMPLETE LABEL AMENDMENTS, WITH A COVER LETTER HIGHLIGHTING EACH PRECAUTION
AND RESTRICTION OF THE BROMOXYNIL LABEL. AS WELL AS A DESCRIPTION OF
THE PRODUCT RELABELING PLAN, WILL BE TELEFAXED TO EACH DISTRICT AND
REGIONAL OFFICE. WITHIN RHONf-POULENC AG COMPANY.

OVERNIGHT MAIL, INCLUSIVE OF IDENTICAL INFORMATION, WILL BE SENT TO
EACH FIELD REPRESENTATIVE WITHIN THE COMPANY, AS WELL AS APPROPRIATE
RPAC ADMINISTRATIVE AND PLANT PERSONNEL.
DAY 2 FOLLOWING EPA APPROVAL OF COPY

ANNOUNCEMENT OF THE BROMOXYNIL LABEL CHANGES AND THE PRODUCT RELABELING
PLAN WILL BE SENT. VIA OVERNIGHT MAIL TO ALL BROMOXYNIL DISTRIBUTORS.

RPAC FIELD SALES PERSONNEL WILL BEGIN MAKING PERSONAL CONTACT CALLS
ON BROMOXYNIL DISTRIBUTORS AND RESELLERS GIVING CONTACT PRIORITY TO
THOSE RETAILERS REPRESENTING THE MAJORITY OF BROMOXYNIL SALES TO GROWERS.
IN ADDITION RPAC FIELD DEVELOPMENT REPRESENTATIVES WILL BEGIN CONTACTING
UNIVERSITY EXTENSION PERSONNEL AND WEED SCIENTISTS.  AN ESTIMATED 3,000
TOTAL CONTACTS CAN BE MADE WITHIN TWO WEEKS.

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 DAY  5  FOLLOWING  EPA APPROVAL OF  COPY

 DIRECT MAIL  LETTERS OUTLINING THE  LABEL AMENDMENTS AND NEW RESTRICTIONS
 WILL BE SENT TO  DISTRIBUTORS. DEALERS. CUSTOM APPLICATORS AND UNIVERSITY
 EXTENSION PERSONNEL -  AN  ESTIMATED 12.000  INDIVIDUALS.  THIS WILL REINFORCE
 PERSONAL CONTACTS  BY RPAC FIELD  PERSONNEL.
DAY 14 FOLLOWING  EPA  APPROVAL OF COPY

"RESTRICTED-USE"  CLASSIFICATION OF BROMOXYNIL HERBICIDES WILL BE COMMUNICATED
TO SOME 35.000 GROWERS  THROUGHOUT HIGH INTENSITY USE-AREAS. VIA DATA-LINE.
A COMPUTERIZED INFORMATIONAL  SYSTEM, WITH COPY THAT INSTRUCTS GROWER
TO SEEK DETAILED  LABEL  USE AND HANDLING PRECAUTIONARY INFORMATION THROUGH
THEIR AG CHEMICAL SUPPLIER.

DIRECT MAIL LETTERS OUTLINING THE LABEL AMENDMENTS AND NEW RESTRICTIONS
WILL BE SENT TO FARM  MANAGERS AND CROP CONSULTANTS.

PRINTING OF POINT-OF-PURCHASE POSTERS WILL BE COMPLETED AND SENT TO
RESELLERS. TO BE  DISPLAYED AT THE RETAILER LOCATION TO ALERT GROWERS
WHO'PURCHASE BUCTRIL*.  BUCTRIL* + ATRAZINE OR BRONATE* HERBICIDES OF
THEIR "RESTRICTED USE"  CLASSIFICATION.

A RADIO CAMPAIGN, TARGETED AT GROWERS WITHIN BROMOXYNIL USE-AREAS WILL
KICK-OFF ON DAY 14 TO COMMUNICATE THE "RESTRICTED-USE" CLASSIFICATION
OP BUCTRIL*. BUCTRIL* + ATRAZINE AND BRONATE* AND  0  Ni'.Ut  
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                            DEALER/DISTRIBUTOR  LETTER
 ATTEXTIO* -  LABEL CHANGES  FOR  BRONATE*. BUCTRIL* AND BUCTRIL* * ATRAT1NE
 This Is  to  Inform  you that  BRONATE*. BUCTRJl*  ana BUCTRIL* * Atrazlne
 broadleaf herbicides  have  recently  been reclasslfled as  "RESTRICTED USE
 PESTICIDES"   and  that  the  labels  have  been  amended  to  Include  new
 precautionary  statements,  additional  protective clothing requirements, and
 new handling and application  restrictions.

 These  changes have  been Implemented because  recent tests  have shown that
 exposure  to  the  active Ingredient  1n  these products  has  caused  birth
 defects  1n  laboratory animals.   The new  label  amendments have been added to
 substantially  reduce  the  exposure   to   these  products when  handling  or
 applying.                                        .  

 Enclosed  you will .find copies  of each new label for your  review.   Please
 take time to become'familiar  with this Information 1n order that you are 1n
 fu*l  compliance with  each  Important  amendment.    Significant  additions
 Include:   1}  New warning  statements; 2) Specific use directions requiring
 additional  protective clothing  and clean-up procedures; 3) The requirement
 of  mechanical  transfer  systems  when  handling  30 gallons or more product 1n
 a single  day;  4) Use of enclosed cabs when applying  180 or more acres In a
 single day; and  5) New  chemlgatlon and aerial application restrictions.

 In  an effort  to  assure .that  all Inventories  of  BRONATE*.  BUCTRIL* and
 BUCTRII*  + Atrazlne  are stlckered with these changes,  a relabelling-program
 Is  being  Implemented by  Rh5ne-Pou1enc and within the  next several days your
 RP   Field  Representative  will   be   delivering   adequate   quantities  of
 self-adhesive  labels  with  Instructions  for  relabelling  your  current
 Inventories.    To perform  this  task Rhdne-Poulenc will   compensate  your
 efforts  at  a  rate  of  JO.SO/case.  30-gallon drum or UO-gallon mini-bulk
 unit, and will verify your  participation  with  an enrollment form at time of
 label  delivery.   In  addition, your RPAC  Field Rep  will  provide Resellers
 with a polnt-of-purchase  poster  for hanging,  and   grower  handouts,  both
 alerting him to  the  label changes of  which he mist comply.

 Once you  have received revised labels,  no product  may  be  shipped  or sold
 until stlckered  with the  new label. If  for  any  reason distributors.don't
 receive  labels  within  7   days  of  receipt of  this  letter  (14 days for
Retailers),  pleast   call   the   toll  free   Rh6ne-Poulence   Hot-Line  at
 1-800-334-9745,  and  labels will be Immediately shipped to you.

Thank  you  for  your  continued   support  and  help  1n communicating  this
 information.   Please  contact your RPAC  Field Representative  1f you  have
 questions or specific Issues  relating to  this matter  that you would like to
 discuss.

                                      Sincerely,

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                        UNIVERSITY/CROP CONSULTANT  LETTER
ATTENTION -  LABEL CHANGES FOR BRONATE*.  BUCTRIL* AND BUCTRIL* * ATRA2INE
TMt  Is  to  Inform  you  that BRONATE*.  BUCTRJl*  tnd BUCTRIl*  Atrazine
broadleaf  herbicides  htve  recently  been  reclasslfied as  "RE5TRJCTED  USE
PESTICIDES"   end  tha-t  the  Ubels   have  ben amended  to  Include  new
precautionary statements,  additional protective clothing  requirements,  and
new handling  and application restrictions.

These  changes have  been  Implemented  because  recent tests  have shown that
exposure  to  the  active  ingredient  in  these  products  has  caused  birth
defects  In  laboratory animals.  The new label  amendments have been added to
substantially reduce  the exposure  to  these products when  Handling  or
tpplylng.

Enclosed you will  find copies of each  new label for your  review.   Please
take time to become familiar with this Information  In order that you are In
full  compliance with  each Important  amendment.    Significant  additions
Include:   1)  Mew warning statements;  2) Specific  use directions requiring
additional  protective clothing  and clean-up procedures; 3) The requirement
of mechanical transfer  systems  when handling  30 gallons or more product 1n
a single day; 4} Use  of enclosed cabs when applying 180 or more acres 1n a
single day; and  5)  New chemigation and aerial  application restrictions.

Thank  you  for  your  continued  support  and  help  1n communicating  this
Information.   Please  contact your  RPAC  field  Representative If you have
questions or  specific  Issues relating to this  matter that you would like to
discuss.

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*
f  RH6NE-POULENC
                GROWER  LETTER  TO  BE  AVAILABLE  AT RESELLER  LOCATION
   RHONE-POOLING AO COMPANY


                 TO: BUCTRIL/BUCTRIL * Atrazlne/BRONATE* Users


     BUCTRIL*.  BUCTRIL*  *  Atrazine  and  BRONATE*  herbicides  have  been
     reclassified   "Restricted  Use  Pesticides",   and  additional   label
     restrictions   and   precautions  have  been  added   to  minimize  user
     exposure.

     Please  note  when  review  the revised  product labels  the following
     changes have been made:

        *    Warning Statement:  This  product has been  shown to cause birth
             defects  in  laboratory  animals.  Women  of  chlldbearlng age
             should  be  particularly careful  when handling this product to
             avoid  ingestion and skin contact.

        *    Protective  clothing   requirements  such   as  nitrile   gloves,
             cotton  coveralls,  chemical   resistant shoes,   and   chemical
             resistant  apron  for   mixer/loaders  have  been  added.  Please
             review the label  for full details.

        *    Mechanical  transfer   systems  are  required  to  be  used 'for
             loading-of 30 or  more  gallons of product are used per day.

        *    Enclosed cabs  are  required  for  ground applications If  180 or
             more acres are treated per day.

        *    New  chemigatlon and aerial  application restrictions have  been
             added. Please review the label for details.

     Please thoroughly  familiarize  yourself with  and strictly  adhere to the
     label  requirements  because  the  safety  of you,  the  user,   is our
     foremost concern.  Please contact your local chemical supplier  if you
     have questions or require further Information.

     BUCTRIL  and  BRONATC  are registered  .trademarks   of  RhSne-Poulenc Ag
     Company.
           ?T A^
   UAOeT*lAW6.ES"
            BdTMiBUliCSEAv:CES TELE* NUMOC& M93". A>4CWCnQACH *C IDS

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               RADIO/DATA-LINE COPY
ATTENTION 6ROWERS!

BUCTR1L*/  BUCTRIL* * ATRAZINE  AND  BRONATE* HERBICIDES/
USED  FOR  POT-EMCRGENCE  BROADLEAF  WEED CONTROL/  HAVE
               *
BEEN HE-CLASSIFIED AS RESTRICTED USE PESTICIDES.
FOR COMPLETE  DETAILS  AND INFORMATION/ CONTACT YOUR FARM
CHEMICALS SUPPLIER.  AND REMEMBER ... YOUR SAFETY IS OUR
TOP  PRIORITY.     SO/   AS   WITH  ANY  CROP  PROTECTION
CHEMICALS.  ALWAYS READ  AND FOLLOW  INSTRUCTIONS  ON THE
LABEL.

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       POSTER FOR RESELLER
      BUCTRIL 
     BRONATE  
              l
 BUCTRIL* + ATRAZINE
       ARE NOW
RESTRICTED USE PESTICIDES
 ASK HERE FOR COMPLETE
 DETAILS AND INFORMATION,
 RHONE-POULENC AQ COMPANY

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                          ATTACHMENT  D
In lieu of the sentence which states, "If this product is
packaged in a 30 gallon drum or you will har.-iie a total of 30
gallons or more of this product per day/ you must use a
mechanical transfer system for all mixing arid loading
operations," the complete revised labeling will state, "If you
will handle a total of 3C gallons OL more of this product per
day, you must use a mechanical transfer system for all mixing and
loading operations.  If t-his product is packaged in a 30 gallon
drum, you must use a mechanical transfer system which terminates
in a drip-free hard coupling which may be used only with a spray
or mix tank which has beon.fitted with a compatible coupling.  If
you do not presently own or have access to a mechanical transfer-
system with this type of coupling, contact your dealer for
information on how.to obtain such a system or to modify your
present system."

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ATTACHMENT  B

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                                                        APR 2 5


     DRAFT    PROPOSED PROTOCOL:   DROMOXYNJL tXPOSURZ STUDY



 1.0   INTRODUCTION

      A passive doeiaetry study  shall be conducted to  the
 dermal and  inhalation exposure occurring during routina uaa of
 broooxynil.  The study shall ba  designed so that the
 Environmental Protection Agency  aay be able to:  (1) quantify the
 exposure occurring during nixing/loading, application, and clean-
 up when bromoxynil is applied by ground boon to field crops
 employing rigs where boon lengths typically exceed 30'; (2)
 quantify the exposure occurring  during nixing/loading,
 application, and clean-up when bromoxynil is applied by ground
 boon to crops where  rigs of 20'  to 40* predominate; (3) within
 each subgroup estimate the total potential dermal exposure and
 the  actual  deposition to the skin under the clothing worn by each
 study participant.   As an additional objective, this study or a
 seperate study will  quantify the potential dermal exposure and
 Kin deposition occurring during open pour aixing and loading
 with the new Rhone-Poulenc 2.5 gallon container and a
 conventional 2.5 gallon container*

 2.0   MATERIALS AND METHODS

      2.1   Sits Selection

      The study will address two sain crop groupings.   The first
 grouping shall be crops to which daily treataents of 150 acres or
 nore art typical and boom sices  ef 50' or gr'eater are the norm.
 The  usual application speed i* expected to be approximately 0.5
 acres/minute.  The second grouping shall be crops to which daily
 treatment of 50 to 120 acres is  standard and boom sizes average
 20*  to 40*.  The usual application speed is expected to be
 approximately 0.25 to 0.35 acres/ainute.

      within each grouping tha sites shall be selected based on
 routine use ef bromoxynil or other early post'emergent herbicides
 in that arsa.  A minimum, of tan  sites are to ba used within each
 grouping.

2.2  Cooper at or felection             .   .    .   .	 ...

      Cooperators used in the study are to be individuals
 intending to apply a pott emergent herbicide independent ef
possible participation in the study.  The candidates are te be
 alactad in a manner identical to that employed in the May 4
 Baker Canada/Rhone-Poulenc Study with the exception that a
minimum number ef participants with enclosed tractor cabs shall
 ba required.  The questionnaire  used should be similar to that
used in the Canadian study.  Selected cooperators will receive

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                              2  -

broaoxynil  in a  manner identical to * non-cooparator who would be
obtaining breaoxynil for bia/her uae exeapt that bromoxynil may
 ; providad in a non-atandard containar aa necaasary to
.effectuate  tha study.   Rhone-Poulane may provida elaan coveralls
and nitrila glovas  to study partieipanta.  Tha study participants
will initially be inatructad to  follow label diractions.  Should
tha participant  attempt to handla bromoxynil with lass than tha
labal required protective clothing, Rhona-Poulanc will racord
such deviation froa the label diractions and then require the
participant to utilize ell required clothing.  The normal and
typical wcrfc routines of the participants are not to be altered
once the-study participant has begun handling bro&oxynil during
the aonitoring portion of the study.

2.3  Application Detail*

      Information collected for  each application of broaoxynil
shall include target crop,  data  involving cultivar, growth stage,
date of planting, and row spacing.  Equipment information shall
include sprayer  model and sake,  tractor aodel and make, procedure
and tine required to aix and load the -sprayer and the date and
method of sprayer calibration.   Alterations to the equipment such
as shielding of  booas and opening of windows in closed cab
tractors will be recorded.   Application rate and amount of active
ingredient  handled  shall be recorded as will the actual tiae of
application.

      Field conditions including wind speed and direction,
relative humidity,  rainfall,  temperature, and cloud cover shall
be recorded at each aonitoring site for the duration of each
aonitoring  period.   A description of each test site will be
recorded.

2.4  Dermal  Exposure

      Dermal exposure to all bcdy araaa with the exception of the
hands vill  be aonitored in a Banner that will permit the
estiaation  of potential dermal exposure and dermal exposure to
the skin.   Potential dermal exposure vill be 'monitored by the
Our ham-Wolfe patch  aathod (Measurement of Exposure of Workers to
Pesticides,  Bull. Wld Kith Org., 1962, 26:75-91).  Patches shall
be placed in a manner specified  in Subdivision U of the Agency's
Pesticide Assessment Guidelines  on the outside of the
cooperator's clothing.   Dermal exposure to body areas covered by
clothing shall be monitored using either whole body dosimeters
composed of a long  sleeve cotton T-shirt and long legged cotton
underpants  or by a  fluorescent tracer technique.  The whole body
dosiaeters,  if selected,  will be provided to each cooperator by
Rhone-Poulenc at least one day prior to the study and shall be
placed on each cooperator,  by the cooperator, at the time that
tha cooperator gets dressed to perform the day's worX routine.
Tha whole body dosimeters are to be worn under all clothing

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                            - 3 -

 normally worn  by  the  eoeperators.  racial exposure may be
 monitored  by the  use  of  facial swabbing in liau of doaiaeter*.
 Hand  exposure  will  be monitored by u* of hand rinses.

      The  monitoring  paried vill oonsist of the handling of not
 less  than  IS Iba  ac.tive  ingredient with the exception that
 external patches  will be changed and hand rinses will be
 conducted  at the  end  of  each mix/load cycle and each application
 cycle.

 2.5   Inhalation Exposure

      Inhalation  exposure will be monitored by use of personal
 air samplers.  The  air saaplers will be turned off during each
 break in the work routine likely to exceed 30 minutes.  The
 duration of the sampling period should be the entire day's work
 routine; however* caution must be taken to prevent breakthrough
 from  saturation of  the collection oedia.  The duration of
 sampling and calibration of air flov vill be conducted for each
 eaaple period.

 3.6   REPLICATIONS

      A replicate is  defined as one monitoring period consisting
 of the handling of  at least IS Ibs active ingredient.  The
 residue levels of external patches for each body area and hand
 rinses will be combined  in the calculation of total potential
 dally exposure for  each  job function and the combined nixing,
 loading, and application functions.  For each crop grouping a
 minimus of ten sites  are to be selected.  For each crop grouping
 a -minimum of 20 replicates shall be monitored.  For each set of
 20 replicates, a  minimum of 7, but no more than 13 replicates,
 hall involve application from enclosed tractor cab*.  A total of
 at least 40 mixer/loader/applicator replications will be
 conducted for the study.  Monitoring of the exposure resulting
 from  the ure of the new  2.5 gallon container may be conducted
 either as an ancillary portion of the study or as a separate
 study and must consist of a minimum of 15 replications of the new
 2.5 gallon container .and IS replications involving a conventional
 2.5 gallon container.  lach set of 15 replications vill involve a
minimum of five individuals at three different sites.  A
replicate for this  portion of the study is defined as one
mix/load cycle, in. vhicft  a spray tank is filled to capacity.
2.7  QUALITY ASSURANCE

      All quality assurance as defined in Subdivision U of the
SFA's Pesticide Assessment Guidelines will be required.

3.0  DATA ANALYSIS

      The purposes of this study are to quantify the exposure

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                            - 4 -

received during the  use of broaoxynil end the identification of
regulatory option* that aay be required to reduce exposure.

      The data will  be presented as a mean exposure and  range.
The standard deviation will also be determined.  Non-parametric
or other appropriate statistics may be ecployed to determine the
statistical significance of different variables in determining
exposure.  Major  emphasis will be placed on tractor type, boom
size, and tank site. Post priori analyses nay be conducted on
other variables depending on observed patterns in the data.   A
priori statistical tests will.be defined in the protocol by the
Agency.
A priori statistical aethods will test the following null
hypotheses: 1) Exposure during mixing/loading with standard 2.5
gallon containers is the same as with the new 2.5 gallon
containers; 2) Exposure during application involving snail rigs
is the saae as those involving large rigs; and 3) Exposure during
application froa  open tractors is the sane as from enclosed
tractor cabs.  Any post priori statistical analysis will be
determined upon receipt and assessaenfof the data.  The Agency
fully recognizes  the fact that exposure data is inherently highly
variable (C.v. >  100%) and that identification of variables
having statistical significance at p < 0.05 aay not occur without
requiring an even greater nuaber of replications.  Such an
undertaking would be prohibitive in cost.  Trend analysis of the
data aay be conducted in the absence of statistical significance

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  	      UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
^
 */
       *                  WASHINGTON, D.C. 20460
                                                          OFFICE OF
                                                   PESTICIDES AND TOXIC SUBSTANCES
                          JUL I  3 1987


MEMORANDUM

SUBJECT:  Compliance Strategy for the Cancellatio
          of Carbon Tetrachloride

FROM:     John J. Neylan III, Director
          Policy and Grants Division
          Office of Compliance  Monitorin

TO:       Addressees
     Attached is the Compliance Strategy for the Cancellation
of Carbon Tetrachloride.  The attached strategy provides
guidance for the enforcement of the November 12, 1986 order
which cancelled all pesticide products containing carbon
tetrachloride, except those registered for use on encased
museum specimens.

     This strategy is effective immediately and calls for
compliance monitoring of the cancellation order through
inspections of registrants, producers, dealers and users of
cancelled products.  Inspections will  be conducted by States
with Cooperative Enforcement Agreements, and EPA in States
without Cooperative Enforcement Agreements, as part of their
current routine inspections.

     We appreciate.the comments offered on the May 5, 1987
draft of this strategy.-  Most of the comments  were editorial
and have been incorporated into the final document.  However,
one commenter suggested that the strategy should also
address the disposal  of any carbon tetrachl oride products.
OCM does not believe  that this issue should be addressed
in the strategy.  OCM recommends that the disposal of any
remaining stocks of carbon tetrachloride should be in
accordance with the label directions.

     If you have any  questions concerning the  attached strategy,
please contact Dan Helfgott of my staff at FTS 382-7825.


Attachments

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                            ADDRESSEES
     Douglas D. Campt     (TS-766C)
     Frederick F. Stiehl  (LE-134A)
     Stanley Abramson     (LE-132A)
     Peg Anthony          (EN-342)
     Ken Shiroishi
     Davi d Hannemann         "
     John  Martin
     John  J. Neylan III
     Jerry Stubbs            "
     Mike  Wood
     Dexter Goldman          "

     Jake  Mackenzie
     Western Regional Compliance Director

     A. Charles Li ncoln
     Eastern Regional Compliance Director

I     Louis F.  Gitto, Director
     Air Management Division

II   Barbara Metzger, Director
     Environmental Services Div.

Ill  Stephen R. Wassersug, Director
     Hazardous Waste Management Div.

IV   Winston A. Smith, Director
     Air,  Pest. & Toxic Mgmt Div.

V     William H. Sanders III, Director
     Environmental Services Div.

VI   William B. Hathaway, Director
     Air,  Pesticides & Toxics Div.

VII  William A. Spratlin, Director
     Air & Toxics Division
VIII Irwin L. Dickstein, Director
     Air & Toxic Subs. Division

IX   Jeffrey Zelikson, Acting Director
     Toxics & Waste Management Oiv.

X    Gary 0'Meal, Di rector
     Air & Toxic Hivision
                    Gerald M. Levy, Chief
                    Office of Pesticides & Toxic Sub

                    Ernest Regna, Chief
                    Pesticides & Toxics Sub. Br

                    Larry Miller, Chief
                    Toxic & Pesticides Branch

                    H. Kirk Lucius, Chief
                    Pesticides & Toxic Subs. Branch

                    Phyllis Reed, Chief
                    Pesticides & Toxic Subs. Branch
                     Norman E. Dyer, Chief
                     Pesticides & Toxics Subs. Branch

                     Leo Alderman, Chief
                     Toxics & Pesticides Branch

                     Alvin Yorke, Chief
                     Toxic Substances Branch

                     Richard Vaille, Chief
                     Pesticides & Toxics Branch

                     Anita Frankel, Chief
                     Pesticides & Toxic Subs. Branch
cc:  Jim Lamb
(TS-788)

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                .  COMPLIANCE  STRATEGY  FOR  THE
              CANCELLATION OF CARBON TETRACHLORIDE
OVERVIEW
     In 1984,  the Agency suspended all  registrations  of
pesticide products containing carbon tetrachloride,  except
those products registered for use on encased museum  specimens,
after registrants failed to respond to  a FIFRA 3(c)(2)(B)  Data
Call-In.   On July 23, 1985, the Agency  issued a Stop  Sale,  Use,
or Removal  Order (SSURO) to all registrants covered  by the
suspension  order.  This SSURO stated that registrants may  not
legally distribute, sell, offer for sale, hold for  sale,  ship,
deliver for shipment, or receive and (having so received)
deliver or  offer to deliver pesticide products containing
carbon tetrachloride after the date of  receipt of the SSURO.
Registrants who  later agreed to voluntarily cancel  their
registrations, as well  as all persons who sell or distribute
pesticide products containing carbon tetrachloride,  were
allowed to  distribute,  sell, offer for  sale, hold for sale,
ship, deliver for shipment, or receive  and (having  so received)
deliver or  offer to deliver carbon tetrachloride until December
31, 1985.  Stocks were  allowed to be used until June  30,  1986.

     On November 12, 1986 (51 FR 41004), the Agency  issued a
Notice of Intent to Cancel (NOIC) for all remaining  suspended
registrations of pesticide products containing carbon tetra-
chloride except  those products registered for use on  encased
museum specimens.

     Carbon tetrachloride was present as an active  ingredient
in pesticide products registered for use as fumigants on  stored
grain, in flour  milling and grain processing plants,  as  well  as
on encased museum specimens in storage.  All registrations for
pesticide products containing carbon tetrachloride  as an  active
ingredient, except for use on encased museum specimens,  have
now been cancelled.

     Carbon tetrachloride poses significant toxicological
risks, and may contribute to the breakdown of the atmosphere's
ozone layer.  The use on encased museum specimens will  be
allowed to continue because the current label  instructions are
sufficient  to reduce applicator exposure so that the benefits
outweigh the risks.

     Compliance  with the Cancellation Order will  be determined
through inspections of registrants, producers, dealers,  and
users of cancelled products.   Inspections will be conducted by
States with Cooperative Enforcement Agreements, and EPA  in
States without Cooperative Enforcement Agreements,  as part of
their current routine inspections.

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                              -2-
REQUIREMENTS OF THE RULE
     All  pesticide products containing carbon  tetrachloride,
except for use on encased museum specimens,  were  cancelled
thirty days after publication of the NOIC  or the  date  of
receipt of the Notice by the registrant,  whichever  date was
later.

Regulated Industry	

     All  registrants, producers, distributors, and  users  of
carbon tetrachloride other than those with products registered
for use on encased museum specimens.  At  the time of the  ori-
ginal  Data Call-in, there were 52 registrants  and 114  registra-
tions.  Vulcan Formula 72 (EPA Registration  Number  5382-2)  is
the only  product registered for use on encased museum  specimens.

     Carbon tetrachloride is also known as perchloromethane
and tetrachloromethane.

Existing  Stocks	

     Previous regulatory action has already  prohibited regis-
trants and retailers from distributing, selling,  offering for
sale,  holding for sale, shipping, delivering shipment, or
receiving and (having so received) delivering  or  offering to
deliver carbon tetrachl oride after December  31, 1985.
Additionally, all provisions for use, except use  on encased
museum specimens, have been prohibited since June 30,  1986.
Therefore, the November 12, 1986 NOIC provides for  no  additional
existing  stocks or use provisions.  Noncompliance with the
carbon tetrachloride cancellation order is a violation of FIFRA
12(a)(l)(A) and 12(a)(2)(K).


COMPLIANCE MONITORING

     Compliance with the Cancellation Order  will  be determined
by inspection of registrants and producers of cancelled products,
inspections of dealers and users, and investigation of tips  and
complaints.

Neutral Administrative Inspection Scheme	

     Since the issuance of the Cancellation  Order is an admini-
strative action which cancels all carbon tetrachloride pesticide
products suspended for noncompliance with the FIFRA 3(c)(2)(B)
Data Call-In, inspections for violations of  this  cancellation
order will take place within the existing compliance monitoring
framework.

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                              -3-
ALLOCATION OF RESPONSIBILITIES
Office of Pesticide Programs
0 Will  develop and provide OCM with a list of those products
  which have been cancelled.
Office of Compliance Monitoring
0 Will develop and transmit the Compliance Monitoring Strategy
  to the Regions.

0 Will transmit the list  of those products which have been
  cancelled to the Regions.

0 Will transmit the list  of registrants and producing establish-
  ments of carbon  tetrachloride.


Regions	

0 Will provide copies of  the Compliance Monitoring Strategy to
  States.

"Will distribute  a list  of products, registrants and producing.
  establishments to the States.

0 Will conduct inspections  in  States without Cooperative
  Enforcement Agreements  as part  of their routine inspectional
  schedule.

0 Will take enforcement action as appropriate.


States	

0 Will conduct inspections  as  part of their routine inspectional
  schedule.

0 Will take enfocement action  as  appropriate provided they  have
  the authority.

0 Will report to the Regions on actions taken under the carbon
  tetrachloride cancellation.

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                            ATTACHMENT


          CARBON TETRACHLORIDE REGISTRANTS AND PRODUCTS


                           REGION I (1)

Uniroyal Chem. Co.
74 Ami ty Rd.
Bethany, CT 06525
EPA Reg. No.  : 400-192,-193,-197 ,-200 ,-203 ,-268
                          REGION II (3)
Rochester Midland
Box 1515
Rochester, NY 14603
EPA Reg. No. :  527-11

Prentiss Drug & Chem. Co.
21 Vernon St. C.B. 2000
Floral Park, NY 11001
EPA Reg. No. :  655-624

Bernard Sirotta Co., Inc.
67 35th St.
Brooklyn, NY 11232
EPA Reg. No. :  2826-1

                          REGION III (0)

                          REGION IV (11)

Lester Labs
2370 Lawrence St.
Atlanta, GA 30344
EPA Reg. No. :  337-16

Hill Manufacturing, Inc.
1500 Jonesboro Rd., SE
Atlanta, GA 30315
EPA Reg No. : 402-54

Quinn Drug & Chem. Co.
Box 847
Greenwood, MS 38930
EPA Reg. No. :  416-48

Selig Chem. Industries, The
840 Selig Dr.,  SW
Atlanta, GA 30373
EPA Reg. No. :  491-2,-47,-82,-154,-190

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                               -2-

Southland Pearson and Co..
Drexel Chem. Co.
Box 9306
Memphis, TN 38109
EPA Reg. No. :  723-19

Peach County Property Inc.
Sureco
E. Main St. Box 938
Fort Valley, GA 31030
EPA Reg. No. :  769-70

Oxford Chemicals
P. 0. Box 80202
Atlanta, GA 30366
EPA Reg. No. :  3635-136

Stephenson Chem. Co. Inc.
Box 87188
College Park, GA 30337
EPA Reg. No. :  4887-57,-127

Vulcan Materials Co. Chem.  Div.
P. 0. Box 7689
Birmingham, AL  35253
EPA Reg. No. :  5382-1,-2,-4,-6 ,-7 ,-9,-11,-31,DC38000100

Big F Insecticides, Inc.
Box 3346
Jackson, TN 38303
EPA Reg. No. :  33161-2

Mid America Chem. Co.
P. 0. Box 490
Montrose, AL 36559
EPA Reg. No. :  36480-47,-48,-49,-50,-51

                           REGION V  (5)

Riverdale Chem. Co.
220 E. 17th St.
Chic. Heights,  IL 60411
EPA Reg. No. :  228-8

Dow Chemical USA
P. 0. Box 1706
Midland, MI 48640
EPA Reg. No. :  464-32,-34,-97,-171,-181,-188,-193 ,-216,-227

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                               -3-
Walter Haertel  Co.
8719 Lyndale Ave So.
Minneapolis, MN 55420
EPA Reg. No. :  821-2

E. H. Leitte Co.
Box 180
Lake Elmo, MN 55042
EPA Reg. No. :  939-25

Universal  Cooperatives Inc
7801 Metro Parkway  P. 0.  Box 460
Minneapolis, MN 55440
EPA Reg. No. :  1386-463

                          REGION VI (6)

Main Pro.  Inc.
P. 0. Box  153249
Irving, TX 75015
EPA Reg. No. :  1325-22,-51

Staffel
ESCO Distributor Inc.
301 1/2 Staples St.
Corpus Christi, TX  78411
EPA Reg. No. :  3286-8098

Voluntary  Purchasing  Group, Inc.
P. 0. Box  460
Bonham, TX 75418
EPA Reg. No. :  7401-82

Grain Conditioners , Inc.
2622 Poydras St.
New Orleans, LA 70119
EPA Reg. No. :  10203-1

Soweco, Inc.
411 So. Parker'St.
Amarillo,  TX 79106
EPA Reg. No. :  21327-8145

J. Chem. a division of Fumigators Inc.
P. 0. Box  5421
Houston, TX  77012
EPA Reg. No. :  36301-5

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                               -4-

                         REGION VII  (17)

Bartels and Shore Chem.  Co.
1400-02 St. Loui s Ave.
Kansas City, MO 63110
EPA Reg. No. :  413-51

Industrial  Fumigant Co.
601 E. 159th St.
Olathe, KS 66061
EPA Reg. No. :  485-7,-9,-13,-15 ,-16,-17

MFA Oil CO.
Box 423
Shenandoah, IA  51601
EPA Reg. No. :  746-93

Douglas Chem. Co.
P. 0. Box 297
Liberty, MO 64068
EPA Reg. No. :  1015-10,-20,-22,-27,-29,-33,-36 ,-53

Warren Dougas Chem Co.,  Inc.
3002 F St.
Omaha, NE 68107
EPA Reg. No. 1616-4

Weevil-Cide Co. a subs,  of Research  Products  Co.
411 N. 7th St.- Box 1057
Salina, KS 67401
EPA Reg. No. :  1629-1

Knox Chem.  Co.
7625 Page Blvd.
St. Louis,  MO 63133
EPA Reg. No. :  1645-12

Farmland Industries Inc.
P. 0. Box 7305
Kansas City, MO 64116
EPA Reg. No. :  1990-116,-184,-392,KS-83000400

Patterson Green-Up Co.  Div of  Curry  Cartwright,  Inc.
1400 Union Ave.
Kansas City, MO 64101
EPA Reg. No. :  2169-92

PBI/Gordon Corporation
1217 W. 12th St.- P. 0.  Box 4090
Kansas City, MO 64101
EPA Reg. No. :  2217-108

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                               -5-

The Huge Company,  Inc.
7625 Page Ave.
St. Louis, MO 63133
EPA Reg. No.  :  2270-5

Research Products  Co.
Box 1057
Salina, KS 67401
EPA Reg. No.  :  2548-3,-13,-22,-30,-48

Chemi.  Sol Chem. and Sales  Co.
P. 0.  Box 1485
Hutchison, KS
EPA Reg. No.  :  2618-2

Brayton Chem. Inc.
P. 0.  Box 437
West Burlington, IA  52655
EPA Reg. No.  :  2993-7,-14,-23

Ferguson Fumigants,  Inc.
93 Ford Lane
Hazlewood, MO 63042
EPA Reg. No.  :  3886-13,-18,-136

Stewart Sanitary Supply  Co.,  Ltd
P. 0.  Box 15061
St. Louis, MO 63110
EPA Reg. No.  :  43954-6

Kaw Val1ey, Inc.
1801 S. 2nd St.
Leavenworth, KS 66048
EPA Reg. No.  :  44215-58,-59,-60,-61,-62

                         REGION VIII  (3)

Lystad Inc.
Box 1718
Grand Forks,  ND 58201
EPA Reg. No.  :  2881-21

Falls  Chemi cals Inc.
P. 0.  Box 2345
Great Falls, MT 59403
EPA Reg. No.  :  40831-21

Morgro Chem. and Energy  Corp.
145 W. Central  Ave.- P.  0.  Box  151048
Salt Lake City, UT 84115
EPA Reg. No.  :  42057-98

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                               -6-

                          REGION IX (5)

Stauffer Chem. Co.
1200 S. 47th St.
Richmond, CA 94804
EPA Reg. No. : 476-537,-1112,-1113,-1543

Hockwald Chem., Div. of Oxford Chem.
275 Valley Dr.
Bri sbane, CA 94005
EPA Re-g. No. : 1111-132

Coyne Chem. Co.
999 Anderson Dr., Suite 140
San Rafael , CA 94901
EPA Reg. No. : 3050-23

Cardinal Chem. Co.
'Green and Sansome Streets
San Francisco, CA 94111
EPA Reg. No. : 5440-6,-20,-22

Siskiyou County Dept. of Agriculture
525 S.  Foothill Dr.
Yreka,  CA 96097
EPA Reg. No. : CA79027400
                           REGION X (1)
Atomic Chem. Co.
Box  1111
Spokane, WA 91210
EPA  Reg. No. : 6152-5,-6

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i ii  ;j
     3   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                         WASHINGTON. D.C. 20460


                             JAN 15 1976
                                                     OFFICE OF ENFORCEMENT
 SUBJECT:  Enforcement of Administrator's Decision and
             Order Suspending Most Uses of Heptachlor and
             Chlordane '
 TO:         Enforcement Division Directors
             Pesticide Branch Chiefs

 FROM:      A. E. Conroy U.. Director
             Pesticides Enforcement Division (EN-342)
 I.  LEGAL DEVELOPMENTS
 istrator on the Suspension of Heptachlor-Chlordane (In re Velsicol
 Chemical Corporation, et al. , FEFRA Docket No.  384) ordered the
 suspension 01 "registrations of all pesticide products containing hepta-
 chlor or  chlordane for use on corn, household, garden, lav/n, and
 turf pests,  use against ticks  and chiggers, and use as a'conslituent
 in shelf paper.  This Final Order reversed the December 12, 1975,
 "Recommended Decision" of  Chief Administrative Law Judge Herbert L.
 Perlman dismissing the Administrator's July 29, 1975,  "Notice of
 Intent to  Suspend. "*

    On January 8, 1976, the Agency filed a "Suggestion for Clarifcation"
 (attached) requesting the Administrator to adopt the Agencyrs interpre-
 tation of  the meaning and limitations of  the Final Order.  The Admin-
 istrator has requested briefs on the issue of the appropriateness of a
 clarification.

    Finally, appeals have been filed by the Environmental Defense
 Fund (in  the Court of Appeals for the District of Columbia Circuit)
 and by Velsicol (in the Court of Appeals for the Sixth Circuit). The
 Velsicol  appeal of the District Court's denial of its motion for pre-
 liminary injunction against the Administrator's issuance of the July
 " Copies of the Administrator's "Conclusions" and the "Order" are
 attached.

-------
                              -2-

 29. 1975, "Notice of Intent to Suspend" remains in abeyance in the
 Sixth Circuit as well.

 II.  CURRENT AGENCY ACTIVITY
        The office of the Hearing Clerk is preparing to serve by  :
certified mail copies of the Final Order  on all parties to the suspen-
sion proceeding.  In addition, the Registration Division  is preparing ,
to notify all registrants by letter of their status under the  Order and
of what label  amendments, if any, are necessary for them to continue
the registration of their products in accordance with the Order.

HI.  ENFORCEMENT

        The Pesticides Enforcement Division is  preparing a general
strategy to enforce the Administrator's Order.   This strategy will
provide status of registrants vis a vis the cancellation and suspension
proceedings,  lists of formulatorjand distributors of chlordane and
heptachlor products, and status of product uses as clarified by any
'subsequent Orders.

        Pending the completion of this  strategy,  regions  should pro-
ceed with normal surveillance and inspection  activities relating to
chlordane  and heptachlor products.  Enforcement actions should await
official notice of ^suspension to subject registrants.

        Until that time you  may find it helpful  to deal with general
inquiries as follows.

             1) So far as PED is able to determine at this time, stoc
                                        which were formulated after
               are illegal for further gh-jr^o.-*  ^-i^ ~r ,IC_A.

             2) Persons desiring to dispose of illegal stocks may arrange
with involved regions to ship the products for assorted disposal, includ-
ing for return to a supplier, for export, or in accordance vith directions
provided by the Office of Solid Waste Management.  Disposal" questions
may be referred to Ray Kreuger in Washington at (202) 755-8050. Regional
offices should cooperate in every way possible with responsible efforts to
dispose of suspended chlordane /heptachlor  stocks.

             3) Questions relating to label status should be referred  to
Tim Gardner of the Registration Division,  Washington. (202) 426-9425.
As soon as firm policy exists as to this issue you will be informed of
its substance.

             Should you have questions concerning any facet of the
chlordane /heptachlor suspension,  please contact the appropriate regional
coordinator.

-------
   '>,
         UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                        WASHINGTON. D.C.  20460
                              JA?J r

                                                     OFFICE OF ENFORCEMENT
SUBJECT: Cltr-icr.tl^r. of Heptachlor/Chlordane
           Suspension Order

TO:        Enforcement Division Directors
           Pesticide Branch Chiefs

FROM:    A. E. Conroyll, Director
           Pesticides Enforcement Division (EN-342)


   Please find attached a copy of the Administrator's "Clarification
of Order of December 24, 1975 (In re Velsicol Chemical Corporation
et al., FIFRA Docket No. 384), " dateci January 19, iy75.Although   -
the Administrator did not adopt per se Respondent EPA's proposed
order and table for  clarification (see  my January 15th memorandum
and enclosures), this document makes patent that all registrations
(Federal and State)  of pesticide products containing heptachlor and
chlordane for uses not specifically continued (as set forth in paragraph
4 of the Conclusion  to the December 24th Decision) were suspended.
For purposes of enforcement, "Attachment A" will be used as the
list of uses not suspended.

   Should questions arise concerning the Clarification, or any other
matter relating to the heptachlor/chlordane proceedings, please con-
tact the appropriate regional coordinator.

-------
                  UNITED  STATES  OF Af.rRICA
               niVlRO.'WENTAL  PROTECTION AGENCY
                  BEFORE  THE  ADMINISTRATOR
 iuui>1 Chemical  Corporation
                .FIFRA Docket  Mo. 384
                 Reqistrants.
                      CLARIFICATION- OF .
                ORDER OF  DECEMBER 24, 1975

     C* January 7,  197S, Respondent EPA filed-a Suggestion for
 purification of the  Order of December 24, 1975, in the above-
                                            *     "        f  
 <*?*. irr.cd proceeding, seeking clarification of the uses of
 r-r-i.-cts containing heptachlor and chlordane for which
 TjJ'.lratior.s are not suspended by the December 24 Decision
 *,: Crdcr.  Respondent also submitted a Proposed Order, including
 *A 4*.uctopnt setting forth a proposed list of uses not suspended,
 i-;.?:f.cr with certain explanatory notes.                 .   '
   .  On January 13, 1976,  I "issued a notice of the filing of
 >*-.;>:ftJent's Suggestion for Clarification and Proposed Order
 ' fasted  written  comments. from the parties, thereby
touting my intention to consider the possible need for
 :*'iJc*lion of the  December 24. Decision and Order.*  On
 *v*ry 15, 1 976 ,' written  comments were received from counsel for
 fon v.vre  submitted  by  counsel  for Vclsicol  Chemica
-c'-'rc'  r"?n Oanua>'y 1J^.  19?6,  but not sufficiently in adv
       .uraiiori of  the January 13 notice to be considered th

-------
                               2



 Agriculture of the State of Hawaii; counsel  for some 300



 registrants of various products containing hsptachlor or chlordane;

                                             

 the Environmental Defense Fund; the U.S. Department of Agriculture;



 and Respondent EPA.  All of the foregoing parties, except the



 Environmental Defense Fund, oppose Respondent's suggested



 clarification of the December 24 Order, both on grounds that the

                                                             

 Administrator lacks jurisdiction or authority to clarify, modify,
                                             "                     


 or al ter the .Order .and ..that. the. Order.-is_f inal.^and .cannot. nov/_be. - -



 chanced .ir. the manner proposed by Respondent.



      Even though not expressly provided for in the Rules of



 Practice governing expedited hearings under the FIFRA, I have



.determined that authority does exist to clarify the December 24



 Order and that some clarification is warranted, in view of the



 apparent possibility that its provisions may be unclear.  In my



 view.,  the December 24 Decision and Order are clear and specific



 in their terms and should not require any further elaboration.



 Implicit in Respondent's suggested clarification, however, is the



 notion that proper administration of the Decision and Order by



 the Agency and explicit understanding thereof by all the parties



 require a clear statement of the uses of products containing



 heptachlor and chlordane for which registrations have not been
                                                


 suspended.  In an abundance of caution and concern,"therefore,



 I believe proper administration of the Decision and Order wflV.be



 served and facilitated by the following clarification of the..

 -.*

 December 24 Order.

-------
                                3

       In reviewing the Decision and Order and the possible need  .
   
  for clarification. I have not considered any new evi-JciiCt or
                                                                   /
  argumentation.  I have sought only to discern any possible source
                                      i*
  or sources of any lack of clarity in the expression of my

  intentions at the tims I issued the Decision and Order.  Cc-r.nnsnts

  received from the parties have been roost helpful- in determining
                                                        *
  whether or not my intentions were clearly expressed.  The sole
           . .                                                   '  
  purpose of this clarification is to add clarity to the expression

  of my intentions at ths time I issued tha Decaniber 24 Decision . '

  and Order.

       The December 24 Order, by its terms, provides that all
  *                                                           

.  pesticide products containing heptachlor or chlordane for use
                                                                    

  (1) on corn pests, (2) on household, garden, lav/n, and turf pests

  (both by private homeowners and by pesticide control operators),

  (3) against ticks and chiggers, and (4) as a constituent in

  shelf paper, are suspended [the suspension of products for use on

  corn having a post-effective date of August 1, 1976].  The Order

  further provides that any stocks of technical grade heptachlor

  or chlordane formulated into products intended for such uses

  [after July 29, 19753 nay not be placed in commerce, sold, or used 

  for such purposes or any other purpose not specifically

 :exempted [in the Novemberv.18; 1974, cancellation order] or_
             '   *  '  *"'    '.   *' f
  specifically permitted in'accordance with the Decision of the

  Administrator attached thereto.  .

-------
     Ths uses  specifically  permitted or continued by the
Desision accompanying  the December 24 Ordar  include or.ly those set
forth  in paragraph 4 of  the Conclusions contained in the Decision*
                                                                
and, therefore,  these  uses  (together with  the exempted uses for
subsurface ground injection for  termite control and dipping of
roots  or tops  of nonfood plants) are the only uses not suspended
by  the December  24 Decision and  Order.  All  other registrations
                  "                                          
for uses "of  products ^containing  heptachlor or chlordasie are  
                                                        *
suspended.   Because  th-2  x*ords  "intended for  such uses" in  line 12
of  the Order might be  interpreted as limiting the suspended, uses
to  the four  uses enumerated in the first sentence of the Order,
the words  "intended  for  such uses" are hereby deleted from the
December 24  Order.
     The reasons for the specific enumeration of four uses  
'suspended  in the first sentence  of the Order, while suspending uses
for "any other purpose"  in  blanket form in the  second sentence, are
twofold:   (1)  other  than an occasional reference to certain
fruits and vegetables  and other  miscellaneous crops, the record
(including the Recommended  Decision.of the Administrative  Law
                                        
Judge) does  not  adequately  address many other  (presumably  minor)
uses of heptachlor and-chlordarie, as to-which-little or-'no benefits
evidence was presented at the  hearing, and,  indeed, because'the
record was so  inadequate in this regard, the Administrative  Law
Judge  reconunendcd that such other uses not be continued, and
 *uccision  of  the  Administrator, p.  76

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                              5



(2) the four uses enumerated specifically in the December 24 .



Order nro ainon; t';"  vses as to v;hich sufficient benefits evidence

                                    

was presented at the haariny to permit a risk-benefit assessment.
                           .                                  *
                         .           

Ulanket suspension of uses as to which there was little or no



evidence on benefits was necessary because the* evidence on



care*nogenicity risk v/as applicable to all uses.  In view of the



risk so established, and in the absence of.sufficient benefits



evidence.as to uses  for "any other purpose," it was'of course*



necessary to suspend such other uses, even though (for the reasons

                                '               .            '

indicated above) they could not bs enumerated specifically in the



Order.  .



     As to the grouping of uses on "certain fruits and vegetables



and other miscellaneous crops" [referred to in paragraph 5 of the



Conclusions in the Decision], it was my intention, that the 	
                                                             


provision in the Order applicable to uses for "any other purpose"



apply as well to this grouping of uses.  In stating that "the



record in this proceeding is not sufficient to reach a conclusion"



regarding this grouping of uses,* I stated only that the evidence



on benefits was insufficient to permit the kind of discussion of
          ...                                         "


the risk-benefit assessment which I had used for better documented
                          .                                   
              .                 w.             "

wsos.   Therefore, with respect to this grouping of uses, I reached


    ' "     * "
    same ultimate conclusion as d.iscussed above concerning uses for
          ^-

   f"?eision of the  Administrator* p.  76.

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                              6


"any other purpose" generally, i.e. that, in vicv/ of'the


evidence on carcinogenic!ty risk, and in the absence of sufficient


benefits evidence, these uses are suspended, evsn though  they"
                                                              

could not be enumerated specifically in the Order.  Thus, there is


no inconsistency between paragraph 5 of the Conclusions in the
                                 

Decision and the provisions of the,Order.
*              *                                         
     In view of the foregoing, I do not find it necessary to
                                                

either --adopt or-pcject -the .Proposed-
                                                Russel   E.  Train
                         '              .".''
Dated:  January 19, 1976       "

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                                ATTACHMENT A
                                        1
                        SPECIFIC usns   or cm.onnANi* *. ILKPTACTILOII
                   NOT SUSPENDED 1Y ADMINISTUATOJI'S OUDUU OF 12/24/75
COMPOUNDS) USE(a) * -STATUS OF USC(s)
ehlordane &
heptachlor 
ehlordane &
heptachlor
ehlordane &
' 4
heptachlor
 4
heptachlor
heptachlor
heptachlor 	
ehlordane
eldordane
ehlordane
.' ehlordane
i
Subsurface ground insertion for termite control
Dipping of roots or tops of non food plants
Control of cutworms on corn (both pfe and post
emergence)
Control of narcissus bulb fly
 " *
Seed treatment
.
	 Ant control to achieve pineapple mealy bug
control in Hawaii ' '
la Federal /Slate quarantine programs for
6 .5.6
Japanese Beetle and Imported fire ant
Control of black vine weevil on Japanese Yew
in Michigan
Control of Texas harvester ant in Oklahoma '
Control of inn ported fire ant by private ^
5.7 - * .f
individuals
continued
continued
continued until
8 H /7G only
continued
 continued
continued 	 ""
 . ;
continued  ,
 "  ?
continued
continued
continued
 ehlordane
Control of white fringed beetle attacking food
      8
crops   in 8 S.E. States (AL.FL.GA.LA.MS.NC,
SC. TN)
continued
 ehlordane
Control of soil insects   attacking Florida citrus
continued
"ehlordane
Control of strawberry root pests by pro-plant        continued
treatments
 ehlordane
Control of white grubs in Michican
continued
 1.   All registrations (r edcrai and biaio) 01 pesuciae products containing hcpiacnlor ana
     ehlordane for uses not specifically continued are suspended by the Administrator's
     Decision and Order on the Suspension of Hcptachlor-Chlordanc.. The effect of the
     Order is1 to further prohibit the manufacture, formulation or reformulation of products
 :'. containing Heptachlor or Chlordane for any purpose other than for those registered
     uses which have been exempted in the Order and for manufacturing uses as an
   .  interim step in the. ultimate.formulaUon for.such registered uses. Sale and use of  .
'.     existing stocks-ofrcgistcrcd''products  which were formulated prior to July 30,  1975
     are permitted'for both continued and suspended uses. '  	'~~ :' "~~~~-
2*  PR No lice.74-11  (39 FR 41298) exempted thisiuse from cancellation. Such use
     was similarly exempted from the Notice of Intention to Suspend. 40 FR 34456
     (7/29/75).        '-.-                        '.    -.              .
 3.   Clarified at 40 FR 30522 (7/21/75) to apply to Ute use of emulsifiable or oil
     concentrate formulations  for controlling subterranean termites on.structural
    .sites such as buildings, houses, barns, and sheds, using current control
     practices.   t                            .                          *
 4.   Velsicol has represented  that it would  voluntarily suspend domestic shipments
     of heptachlor for this use ponding resolution of the cancellation proceedings.
 5.   On tlic assumption that Mirc.x is not available.  '
 0.   To include treatments required to certify to pest.free conditions as well as for
 -  .  use in suppression and control programs.     .-           -^	   .	
 7.   To include use on both public and private property by either owner, agent,
     employee..or contractor.        .    ;  .    .        ;'-;'   '".,     '  
 8.   Not intended to preclude use on cotton. However;  uco oh'tobacco is suspended.
 9.   Restricted to citrus root weevils.    .:.!'       "" .

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 5p7 ?   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY -
   
-------
 f &&
'I \j7

     ~'
          ilTED STATES ENVIRONMENTAL PROTECTION AGENCY

                          WASHINGTON. D.C, 20460
CERTIFIED MAIL
Gentlemen:

Subject   :  Notice  of Suspension  for:
 On December 24,  1975,  the Administrator issued his Decision and Order
 on--the. suspension of Heptachlor and Chlordane.  Most federal and state
 registrations  of Heptachlor and Chlordane  were suspended although
 certain uses were specifically exempted, (Refer to the enclosure).  Any
 registration v/hich included a suspended use was suspended effective
 December 24, 1975.  This letter is  to notify you that your above
 registration contained a use suspended-by  the Order and therefore has
 been suspended effective December 24, 1975.
         *                         .
                              
 If you wish to be permitted to continue your registration, you have two
'alternatives.  First,  you may dimply discontinue the use of CMordane
 or Heptachlor  in the formulation of your product.  If.you select this
 approach you will not  be required to submit -a petition for an amendment
 if your product  contains no other insecticides and all insecticide claims
 are eliminated.   If other insecticides are contained you must apply for
 an amended label which in certain instances jnay require new efficacy
 data.  If you  wish to  continue to formulate your product with either
 Heptachlor or  Chlordane you may continue to do s,o only for uses not
 'suspended and  only after you have submitted a petition for a label
 amendment in v/hich all references to suspended uses have been deleted.

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*'*"*,
     tj
          UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
     /                      WASHINGTON. O.C. 20460




  CERTIFIED HAIL
  Gentlemen:

  Subject   :  Notice of Suspension  for:
  -On December 24, 1975,  the Administrator issued his  Decision  and Order
   on the suspension of Heptachlor and Chlordane.  Most  federal  and  state
   registrations of Heptachlor and Chlordane were suspended  although
   certain uses were specifically exempted (Refer to the enclosure).  -Any
   registration which included-a suspended use was suspended effective
   December 24, 1975.  This letter is to notify you that your subject
   registration contained a use suspended by the Order and therefore has.
   been suspended effective December 24, 1975.

   If you wish to be permitted to continue to formulate and/or sell  Hepta-
   chlor and/or Chlordane for uses not suspended, you will be required to
   petition for a provisional amandment of registration.  Such petition 
   should request the "elimination fro'm-your labels of any reference  to
   suspended uses.  It is sufficient to. send a cover-letter  with an  amended
   label or label in which the suspended uses including any  claims referring
   to these^uses haveibeen>blocked^out^ The "granting by-the Agency  of such
   a petition will peroit.-youj^                     and/or sale of Hepta-
   chlor and/or Chlofdane'-for^ex^mpfed us.esV" Petitions for a provisional
   labeling amendment/in accordance.with the enclosure must  be received
   within 30 days of receipt of this letter at the following address:

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       5   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

\   l&*                     WASHINGTON. D.C. 20450
 'no**-0
   ' CERTIFIED
    Gentlemen:

    Subject  :  Notice of Suspension for:
    This is to notify you that on December 24,  1975,  the Administrator
    issued his- Decision and Order on the suspension of Chlordane  and
    Heptachlor.

    This document provides that all  uses of Chlordane and Heptachlor  are
    suspended except those set Yorth on the enclosure.  Your subject  regis-
    tration was suspended effective  December 24,  1975.

    As stipulated in the Administrator's Notice of Intent to Suspend, issued
    on July 29, 1975, the product under this registration may not be  formu-
    lated, shipped, sold or .used after July_ 29; 1975..

    The'Administrator's Decision and Order yriU be published'in the Federal
    Register..in/the^riear'future^    *    ''"'  ''"   '

    Sincerely'yours,
    John B. Pitch, Jr.
    Director
    Registration Division (WH-567)

    Enclosure

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                                    -2-

 It  is  sufficient to send  a  cover letter with an airsr.ded label or
 '1n  which  the  suspended  uses including any  claims referring to these
 uses have been blocked  out.  The granting  by the Agency of such a
 petition  will  permit you  to continue formulation and/pr sale of Hepta-
 chlor  and/or  Chlordane  for  exempted uses.   Petitions for a provisional
 labeling  amendment in accordance v/ith the  enclosure mubt be received
 within 30 days of receipt of this letter at the following address:  .

                        Mr:  Timothy A. Gardner
                        Product Manager  (15)
                        Registration Division (WH-567)
                        Environmental Protection Agency
                        Washington, O.C.  20460.

 The amendment_ wi.ll_not. aferaga.te_yaur-..cighi-to-def end-beth- suspended -or  --
"nonsuspended  uses in the  continuing cancellation proceeding.

 Existing  stocks of EPA registered pesticides containing Heptachlor  or
 Chlordane may be distributed and sold for  suspended uses only if the
 stocks were formulated prior to July 30, 1975.  This date was stipulated
 in the Administrator's Notice of Intent to Suspend, issued on July  29,
 1975.   Stocks of Heptachlor or Chlordane formulated after July 29,  1975,
 may only  be distributed and sold for those exempted uses included in  ths
 enclosure and under labels  containing no  suspended uses.  Stocks which
 you may presently have on hand, if-manufactured or formulated after
 July 29,  1975, may not be shipped or sold  until you receive EPA appr1
 of your amended label.
      *

 The Administrator's Decision and Order  will be published in the Federal
 Register  in the near future.    .                               '      -

 Sincerely yours,
 John B. Ritch, Jr.
 Director
 Registration Division (WH-567T

 Enclosure  

-------
                        srr.ciFic USES   or CHL.ORDANK t- i;r:rTAan.orc
                    NpTSUSJ'tlf.'DED BY ADMINISTRATOR'S O;:i.i:;i OF 12/2-1/75
COMPC)UND(s)
chlordane &
heptachlor
chlordane U
heptachlor
chlordane &
4
heptachlor
4
heptachlor
heptachlor
heptaehlor

US(s)
Subsurface ground insertion for termite control
Dipping of roots or tops of non food plants
Control of cutworms on corn (both pre and post
emergence)
Control of narcissus bulb fly
Seed treatment* *
Ant control to achieve pineapple mealy bug
S
control in Hawaii

STATUS OF USE(s)
continued
continued
. continued until
8/1/76 only
continued
continued
continued
^ *  

 chlordace
In Federal/State quarantine programs for
                6                     5.6
Japanese Beetle  and imported fire ant
continued
 chlordane
Control of black vine weevil on Japanese Yew
in Michigan	
continued
 chlordane
'Control of Texas harvester ant in Oklahoma
continued
 chlordane
Control of imported fire ant by private
            5.7
individuals
continued
 chlordane
 Control of white fringed beetle attacking food
       8                              
 crops  in 8 S.E. States CAL.FL,,GA.LA.MS.NC.
 SC. TN)	
continued
 chlordiuie
 Control of soil insects   attacking Florida citrus
continued
 chlordane
 Control of strawberry root pests by pre-plant     .   continued
 treatments
 chlordane
 Control of white erubs'in Michigan
continued
 j.  All registrations U'cocrai anc state) 01 pesucioe products containing ncpt^cmor and
     chlordane for uses not specifically continued arc suspended by the Administrator's
     Decision and Order on the Suspension of Heptachlor-Chlordane.  The effect of the
     Order is to further prohibit the manufacture, formulation or reformulation of products
     containing Heptachlor or Chlordane for any purpose other than for those registered
~    uses which have been exempted in the Order and for manufacturing uses as an
    interim step in the ultimate formulation for such registered uses.  Sale and use of
     existing stocks of registered products which were formulated prior to July 30. 1975
  *.  are permitted for both continued and suspended uses.                 '  
 3.  PR Notice 74-11 (39 FR 4127?) exempted this use from cancellation. Such use'
    ..was similarly exempted from the Notice of Intention to Suspend.  40 FR 34456
     (7/29/75).."     --- :.--  .                                                "   '
 3.:  Clarified at 40 FR 30522 (7/21/75) to apply to the use of emulsifiable or oil
     concentrate formulations for controlling Mibtcrrancan termites on structural
  /  sites such as buildings, houses, barns, and sheds,  using current control
  .  practices.                                                  '.
 4.  Velaicol has represented that ft would voluntarily suspend domestic shipments
     of heptachlor for this use. pending resolution of .the cancellation proceedings.
 5.  On the assumption that Aiircx is not available.       '     .              
 6.  To include treatments required to certify to pest free conditions  as well as for
     use in suppression  and control  programs.  '*
 7.  To Include use on bath public and private property by cither owner,  agent.
     employee,  or contractor.'
 8.  Not intended to preclude use on cotton. However, use on tobacco is suspended. 
 9.  Jtcstrictcd tojcitrus root weevils. 

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                                   -2-

                       Mr. Timothy A. Gardner
                       Product Manager (15)
                       Registration Division (WH-567)
                       Environmental Protection Agency
                       Washington, D.C.  20460.

The amendment will not abrogate your right to defend both suspended or
nonsuspendec! uses in the continuing cancellation proceeding.

Existing stocks of EPA registered pesticides containing Heptachlor or
hlordane_may. .b_ dis trj bul^d,nd^sjD.ld--ai^^uspgndedaise^-on3jM4-.4Ae	
stocks- v/ere formulated prior to July 30, 1975.  This date v/as stipulated
1n the Administrator's Notice of Intent to Suspend, issued on July 29,
1975.  Stocks of Heptachlor or Chlordane formulated after July 29, 1975,
foay only be distributed and sold for those exempted uses included in the
enclosure and under labels containing no suspended uses.  Stocks which
you may presently have on hand, if manufactured or formulated after
July-29, 1975, may not be shipped or sold until you receive EPA approval
of your amended label.       . .                     '                "

The Administrator's Decision and Order will be published in the Federal
Register in the near future.      ..      -

Sincerely yours,
John  B.  Ritch,  Jr.
Director
Registration Division (WH-567)

Enclosure

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   8   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

   f                   WASHINGTON. D.C. 20460
                           2 3 MAR 1976
                                                  OFFICE OF ENFORCEMENT
SUBJECT: Heptachlor/Chlordane Suspension Order
           Enforcement Strategy

TO:.    , ., Enforcement Division-Dir.ector.s-~	
           Pesticide Branch Chiefs            ^~\

FROM:    A. E.  Conroy II, Director
           Pesticides Enforcement Division
     In my memorandum of February 19, 1976 regarding the status
of Agency activity jon_the Administrator's December 24th Order sus-
pending most heptachlor and chlordane product registrations, I alerted
the appropriate Regional personnel that a more specific strategy for
ensuring compliance would be forthcoming.  This memorandum pre-
sents EPA's enforcement strategy concerning the three categories
of these products: (A) Federally registered products,  all uses of which
have been suspended} (B) Federally registered products, some uses
of which were suspended, but which may continue to be sold and dis-
tributed for continued uses upon amendment of the product's registration
and labeling to delete any suspended uses; and (C) intrastate products
afforded the opportunity to  continue in intrastate commerce until the
completion of the cancellation proceedings.


I.  SUSPENSION ORDER PROVISIONS            -  .__._-

     In previous memoranda,  the terms of the Administrator's Sus-
pension Order have been discussed. To recap, the December 24th Order
and January 19th Clarification provide the following:

     (1) All registrations of pesticide/products containing
        heptachlor and chlordane for uses not specifically
        continued [see "Attachment A  Specific Uses of
        Chlordane and Heptachlor Not Suspended by Admin-
        istrator's Order of 12/24/75TT"for the list of uses
        exempted] were suspended as of December 24, 1975.

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                               -2-

      (2) By invoking the "Special Rule" provision of section
         15(b)(2), the Administrator has provided that stocks of
         EPA registered pesticides containing heptachlor or
         chlordane formulated prior to July 30, 1975,  maybe sold,
         distributed, or used for suspended uses.

      (3) Stocks of heptncMor or chlordane products formulated
         after July 20, 1975 may be sold, distributed, or used
         only for exempted uses,  as per "Attachment Al:.


 H.  CATEGORIES OF HEPTACHLOR/CHLORDANE PRODUCTS '     _ r~vj

      As stated above, there are three categories of heptachlor/chlor-   ..  .
 dane products:

     (A) Federally registered products, all uses of which have been     -~
 susp'e'ndeHI  The Registration Di vision /Office 01" Pesticide Programs
 has notified, by certified mail, all affected registrants that their prod-
 ucts have been finally suspended by the December 24th Order.  1 /  An
 example of a product in this category would be a product regisieced    - -
 for use only on ticks and chiggers.  There are approximately 644 prod-
 ucts registered by over 300 registrants which have been so suspended.  .
 You will find attached to this memorandum a list of suspended product
 registration numbers,  product names, registrant names, and the names
 and addresses where such heptachlor/chlordane products have been pro- .
 duced.
                       *
     (B) Federally registered products, some uses of which have been	
 suspended^  As noted in the introduction and in previous memoranda,  r
 there is a large category of registered products whose uses were sus-
 pended in part by the December 24th Order, but whose sale and distri-
 bution may continue upon [ "provisional"J amendment of the produces
 registration and labeling to delete all suspended uses. A typical product
 in this category would be one registered and labeled for indoor roach con-
 trol and for subterranean termite uses (the former being a suspended use,
 while the latter is a permitted use).  Pending the decisions by the regis- 
 trants to amend or not [such decision- must be made within 30 days of   -
 receipt of the notice of suspension], it is not-possible to determine
 the registration status of products in this category.  Upon RD's comple--
 tion of the necessary registration, review, a region specific list will
 be forwarded to you noting the.status of individual products in this  category.

     (C) Intrastate products.  Although this third category is comprised
 of products similarly situated to those in above categories (A) and (B),
 for purposes of this enforcement strategy,  "intrastate products" are
.being-treated separately.  The Registration Division has notified the
  I/ see myjf eoruary 19.  1976 memorandum entitled "Status Report on the
 fieptachlor/Chlordane Suspension. " and its attachments.

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                            -3-


 registrants of 140 "intrastate" products as to the impact of the
 December 24th Order on their heptachlor/chlordane products.
 These products were being sold only in intrastate commerce when
 they became subject to the FEPCA registration requirements by
 the accelerated activation of section 3 in November 1974. Sub-  
 sequently, all applications for Federal registration were denied
 and the  applicants who timely requested a hearing were made
 parties  to the  cancellation proceeding and the subsequent suspen-
 sion hearings.  Accordingly; these products were equally affected
 by the December 24th Order in that to continue marketing them.
 registrants must delete suspended uses from their labeling.  Please
 note the attached three Registration Division form letters used to
 sppn s e~ thli 9
 You will find an attached list of forty-eight-products in this cate-
 gory whose sale,  distribution, and use was prohibited as of Decem-
 ber 24. 1975. for formulations made after July 29.  1975.  As soon as
 the suspension  status of the remaining products in this category is
. available, you will be advised.           .........  .


 HI. ENFORCEMENT POLICY       -

     The Agency intends to ensure that-the-Administrator's Order
 of December 24th -is strictly complied with by all affected persons,
 including manufacturers, formulators, registrants, wholesalers,
 retailers, and users. The Administrator,  in his December 24th
 Order, provided that products formulated prior to July 29, 1975,
 should be permitted distribution and use through normal channels
 of trade until the stocks are exhaused.  Affected persons were
 informed of the consequences of formulating after July 29th  those
 that chose to continue formulation despite the Notice of Intent
 to Suspend did so  at their own risk.  The Agency wants to ensure
 that the pesticide  producing industry does not interpret a Notice
 of Intent to Suspend as a signal to increase production of the subject
 product during the pendency of the suspension proceeding.

    It has been the general policy of the Agency to request national
 recall where  product registrations have been suspended in order
 to prevent an imminent hazard to man or. his  environment. That
 policy will be applied in the instant case;.r As the initial step in  ....
 implementing this policy, EPA has requested the recall, down to
 and including the retail level, of all heptachlor/chlordane products
 for which all uses were suspended and  which  were formulated
 after July 29, 1975 [category A products].  In addition, the Agency
 intends to request the recall  in some  instances for1 relabeling  of
 all heptachlor/chlordane products formulated after July 29, 1975

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                            -4-


 whose labels contain both suspended and non-suspended uses [category
 B products].  "Intrastate" products [category C products] will be treated
 in a manner consistent with similarily situated Federally registered
 products.


 IV.  ENFORCEMENT ACTIONS.

    As has been the established policy in such matters, enforcement
 actions will be taken, in accordance with normal procedures and at
 levels consistent _with those provided for in the Pesticides Enforcement
 Division Case Proceedings Manual,"against all persons found in viola-
 tion of the heptachlor/chlordane suspension order.                "  

   There exist a number of enforcement action options available .to . :.~i
 ensure compliance with the Administrator's Suspension Order.  As - -^
 previously stated, the Agency has determined that a national recall	
 of violative products would be the most effective and efficient means "  -
 .of ensuring compliance  with the suspension-order.  Because of. the ..._._
 -extra-ordinary number  of products and-firms which are affected by~~-'
 the December 24th Order and the commensurate amount of Agency  -?-
 resources which would be involved in-conducting a formal recall, -the- 
 Agency feels that the procedures  outlined in the Case Proceedings
 Manual,  Chapter 12, for informal recalls would be more appropriate
 in this matter.  Information and guidance with respect to specific en-
 forcement related actions which may be directed toward each of the
 aforementioned categories of heptachlor/chlordane products follows: .:.;

    (A) Federally registered products, all uses of which were sus-
 pended and which were formulated after July 29, 1975.  As per recall'"
 initiation procedures, the Pesticide Enforcement Division has notified
 by certified mail those registrants who had all uses of their heptachlor/
 chlordane product(s) suspended by the December 24th Order, that EPA
 is requesting that all subject products formulated after July 29; 1975>.
be recalled immediately. This letter,- A.copy of which is attached to
 this memorandum, refers the addressee, to the Registration Division
 suspension letter informing the registrant of the registration status of
 his product(s), and continues by specifically requesting that (a) the 	
 company initiate procedures to determine the locations of all quantities-
 of their finally suspended product and the amount of such product at
 each such product location,  (b) that the product be returned to the
 registrant from all locations,  and (c) that the named regional contact
 person be informed of all actions taken in connection with the recall.
                                    
 In your follow-up to determine compliance with the recall request, you
 should:

        (1) be assured that the registrant has recalled the product
            from the retail level,  and either

            (i)   disposed of the product.

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                               -5-


            (ii)  exported product in accordance with section 17, or 2/

            (iii)  sought new registration for continued uses;

        (3) stop sale any such product found in consumer channels
            under section 13;  and

        (4) where appropriate, initiate enforcement action under
            section 14.  3/              ........
                       mmm^  *

    (B) Federally registered  products with both suspended  and con-
 ti'nue'd uses and which were lormuiated alter July 29, IS7a.  As soon
 as these products can be  identified as to their registration status, FED
wgl request eacfa-regigtrarnt'to'trontacL all kauwu distributors; wholg-	
 salers, and retailers that the subject product should not be sold or
 otherwise distributed.  Registrants will be instructed that they should .
 recall from retail level as set forth above for category A products.

 When following-up to determine compliance with the recall  of these pro-
 ducts, you should:

       (1) be assured that the registrant has recalled the  product
            from the retail level, and either

            (i)   disposed of product if amendment to labeling is not
                 made,

            (ii)  exported product in accordance with section 17,

            (iii)  relabeled product with amended label deleting sus-
                 pended uses, or       *	           .

            (iv)  in accordance with EPA approved instructions,
                 overlaid product with approved sticker labels.
                 masked  out suspended uses, or used other means to
          -._     delete suspended uses from the labels;
 21  Registrants: should be informed tfaafthe Agency would interpose
no objection to the export of products affected .by. the suspension order,
but wishes to caution, registrants concerning the recent stipulation
signed by the Department of State concerning the utilization of US funds
for USAID procurements of such products.  See USAID regulation entitled
"Pest Management Program,  Interim Pesticide Procedures," published
in the Federal Register on January 7, 1976.

 3/  Those persons who distribute or sell a suspended heptachlor/
chlordane product in violation of the terms of the December 24th
Suspension Order will be in violation of section 12(a)(l)(A) for non-
registration, as well as section 12(a)(2)(J) for violation of a section
6 suspension,order.                          .  "   "~

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                                -6-


        (2) stop sale any such product found in consumer channels
            under section 13; and

        (3) where appropriate, will initiate enforcement action under
            section 14.  3/
                            *
     (C) Intrastate products. The policies outlined above will also
 apply,  as appropriate,  to intrastate products as they become identified.
 At present, the 48 products  thus far identified will be treated the same-
                                    ^
 [category A products].

     Now that all parties affected by-the Administrator's Decision and
 Order in the heptachlor/chlordane suspension proceedings have been - - 
 duly notified of this action and of their obligations attendant thereto,
 the Agency places the highest priority- on assuring full and immediate -'
 compliance.  The initiation and follow-up of the heptachlor/chlordane
 recall herein authorized will represent a significant addition to" exist-
 ing regional enforcement burdens. It is anticipated that regions will
 exercise initiative and energy in performing,, in addition to program---;. .
 med outputs,  the surveillance^ inspections,- -enforcement actions, -and
 routine follow-up necessary to implement this recall.

     The region should report the. following information to the appro-
 priate regional coordinator as soon as available:

      (1)  the number of firms subject to-recall;       -

      (2) the amount of each product recalled; and

      (3) the  methods of actual or planned disposal
          of recalled material.


 V.  DISPOSAL OF HEPTACHLOR/CHLORDANE PRODUCTS

     Persons desiring to dispose of stocks of heptachlor/chlordane
 should be apprised that they may arrange with the appropriate regions
to ship the product ;for disposal, including return to a supplier, for
 export, or in accordance with directions provided by. the Office of
 Solid Waste Management.  Disposal questions may be referred to
 Mr. Ray Kreugeri Operations Divison, Office of Pesticide' Programs
 [(202) 755-8050], Regional offices are encouraged to cooperate in every
 way possible  with responsible efforts to dispose of suspended heptachlor/
 chlordane stocks.

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                               r 7 -


VI. INDEMNITIES

     The Office of Enforcement has been advised by th? Office of
General Counsel that the registrants of heptachlor/chlordane products
suspended by the December 24th Order are not eligible for indemni-
fication under section 15  of the amended FIFRA.


VH.  INQUIRES

     Should you have any questions concerning any facet of this memor-
andum and  the heptachlor/chlordane  suspension order, please contact .
the appropriate regional  coordinator. -Questions relating to registration
and label status should be referred to Mr. Tim Gardner, Registration -
      ATTACHMENTS            _____ .-._..-.

     Please find attached the following:

        (1)  "Attachment A  Specific Uses of Chlordane and
          -.Heptachlor Not Suspended by Administrator's Order
            of 12/24 /VS.""""             .

        (2)  Copies  of recall request-letters sent-to registrants by
            PED.

        (3)  Three form letters sent by RD/OPP  to "intrastate"
         .:  heptachlor/chlordane registrants.

        (4)  41 FR 7552 (February 19. 1976)  "Velsicol Chemical
      --------- Co. et al. , Consolidated Heptachlor/Chlordane Hearing. ".

        (5)  List of Federally registered heptachlor/chlordane pro-
            ducts, all uses of which have. been suspended [category
          --A products] was mailed by PED to the regional pesticide .
         .  branch  chiefs under separate cover March 17, 1976.

        (6)  List of  the 48 "intrastate". heptachlor/chlordane products,
           .all use  of which were suspended [category C products].

-------
        UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                        WASHINGTON, o.c. 20460
                     27AUG1976
                                                    OFFICE OF ENFORCEMENT
TO:     Enforcement Division Directors
         Pesticides Branch Chiefs

FROM: A. E. Conroy II. Director
         Pesticides and Toxic Substances
         Enforcement Division (EN-342)

RE:     Heptachlor/Chlordane Suspension Or\der
         Enforcement Strategy  CORN USE


     Some confusion has arisen concerning the enforcement response
to certain heptachlor/chlordane product* now on the market which are
labeled for use on corn pests. The Administrator concluded in In re
Velsicol  Chemical Corporation, et al. (Expedited Hearing On Heptachlor-
Chlordane;, 41 Fed. Reg. 7552 (February 19, 1976)  that

      the benefits of continued use of heptachlor and chlordane to
      control cutworms on corn crops during the time which may
      be  required to reach a final decision in the cancellation
      proceeding are not sufficient to outweigh the human health
      risks identified;  provided,  however that particularly in view
      of the difficult transition require? to implement alternative
      cutworm control methods,  the use of heptachlor and chlordane
      to control cutworm on corn crops should be permitted during
      the 1976 corn growing season.  Accordingly,  I have concluded
      that the registration for use of heptachlor and chlordane to
      control cutworms on corn crops should be suspended effective
      August 1, 1976.   */

     As you are aware, the Administrator's heptachlor/chlordane orders
provide the following concerning the legal status of  the various  products:
      */  See also, "Clarification of Order of December 24, 1975, " 41
Fed.TTeg.  7552 (February 19. 1976).

-------
                              -2-

      1.  With the exception of the corn use. all registrations of pesticide
products containing heptachlor and chlordane for uses not specifically
continued (e. g. . chlordane to control black vine weevil on Japanese yew
in Michigan), were suspended as of December 24, 1975.  **/

      2.  By invoking the "Special Rule" provision of FIFRA section 15(b)
(2). the Administrator has provided that stocks of EPA registered pesti-
cides containing heptachlor/chlordane formulated prior to July 30, 1975,
may be sold, distributed,  or used for suspended uses, including use on
corn.

      3.  Stocks of heptachlor or chlordane products formulated after
July 29, 1975, may be sold, distributed,  or used only for  exempted uses
see "Attachment A," enclosed].  Thus, for example, a chlordane product
whose sole registered use was for cutworm control on corn could legally be
produced, distributed, sold, and used without violatingthe December 24
suspension order until this product became finally suspended on August 1,
1976.

     You will remember that prior to our request for the recall of violative
heptachlor/chlordane products, Registration Division,  Office of Pesticide
Programs advised affected registrants that if amended labeling which deleted
all reference to suspended uses was submitted and approved by EPA, the
relabeled product could continue in commerce. To accomodate those pro-
ducers of agricultural products listing corn uses, a decision was made to
allow the registrant to continue to display the directions for use on corn,
provided the following disclaimer was inserted immediately after the crop
designation:  "USE SUSPENDED EFFECTIVE AUGUST  1, 1976. "  Ten com-
panies exercised their option to relabel accordingly; the 19 products areas
follows:

279-2656   NIAGARA CHLORDANE 5 COATED GRANULES
279-2904   CHLOR KIL 10 DUST INSECTICIDE
449-123     SURE DEATH BRAND HEPTACHLOR 3E
449-74     SURE DEATH BRAND HEPTACHLOR 2E
876-55     VELSICOL CHLORDANE 72EC SOIL INSECTICIDE
876-89     VELSICOL BELT 72 ECF
876-99     VELSICOL BELT 33. 3 G AGRICULTURAL INSECTICIDE
            GRANULARS FOR SOIL INSECT CONTROL
876-102     VELSICOL BELT 72 EC AGRICULTURAL INSECTICIDE .
876-172     BELT 40% WP AGRICULTURAL INSECTICIDE'
148-139     CHLORDANE E-8
226-178     TASCO BRAND CHLORDANE 20 GRANULAR
226-219     TOBACCO STATES 50% CHLORDANE WETTABLE POWDER
228-92     RIVERDALE 25% CHLORDANE GRANULES
    .  ^*7  To arrive.at a result consistent with the Administrator's intent to
suspend all use of chlordane/heptachioj; on corn, regardless of target pest,
the use of these pesticides to control the white fringed beetle attacking corn
crops in eight southeastern states (AL, FL, GA,  LA. MS, NC,  SC, and TN)
and to control white grubs on corn in Michigan is also precluded.

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1029-77     AIHGX CrlLORDANt: 8E
2&35-131    RiiD TOP CHLORDANE 8 SPRAY
9C59-51     CIILORDANE 10 GRANULAR
9859-53     CHLORDANE 5 GRANULAR
9859-55     CHLORDANE 25 GRANULAR
'14775       CHLORDANE-TOXAPHENE BAIT NO. 11 (Florida "intrastate"
            Asgrow Florida Company,  P. O.  Drawer D.  Plant City, FL)

     Therefore, after December 24, 1975, no product produced after July 29,
1975 for corn use could be legally distributed  or sold without the above men-
tioned  disclaimer.  The detection of such violative product will continue to
receive Agency response  in the form of a FIFRA section 13(a) Stop Sale, Use
or Removal Order and section  14 action, as appropriate.  It is the Office of
Enforcement view that enforcement  action,  including SSURO's, should not be
taken against the sale and distribution after August 1, 1976 of products bearing
the disclaimer.  The use  of such product on corn after August 1,  1976 is in vio-
lation of the suspension order [12(a)(2)(J)j,  as well as a misuse [12(a)(2)(G)].

    ' To summarize:  (1) products formulated prior to July 30, 1975,  includ-
ing those with directions for use  on  corn, may continue to be sold, distributed,
and used;  (2) products formulated after July 29, 1975, m?/ ne sold,  distri-
buted,  and used only with labeling amended to include only continued uses;
and (3) products formulated after July 29, 1975, with directions for use on
corn, must bear the following disclaimer immediately after the corn use
directions: "USE SUSPENDED  EFFECTIVE AUGUST 1. 1976."

     The Agency is not contemplating at this time 'the recall of the above
products for relabeling to delete  reference to corn uses.   At the conclusion
of the cancellation proceeding, heptachlor/chlordane labels will be revised
to conform with the Administrator's final order.

     All inquiries in this  matter  should be referred to the appropriate regional
coordinator.

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.-.t" :..
         ur;r: .\j STATES ENVIRONMENTAL PROTECTION AGENCY
                         WASHINGTON. D.C. 20*60



                            25NGV W8

                                                      OFFICE OF ENFORCEMENT
   To:     Enforceine.it Division Directors
           and Pesticide Branch Chiefs

   From:  A.  E. Conroy n. Director
           Pesticides and Toxic Substances.
              Enforcement Division

   Re:     Continued Enforcement of the Suspension of Registration
           for Certain Products Containing Chlordane and Heptachlor


      On August 1, 1976, the suspension of existing registrations of
   heptachlor/chlordane products for use on corn was effective as to
   all products formulated-after July 29, 1975.  Thus, the Admini-
   strator's suspension order of December .24, 1975-became completely
   effective as to all subject products formulated after August  29, 1975
   and not  already cancelled.  The  recall of subject products initiated in
   March 1C76 is now essentially coinplete and a final report should be
   submitted to PTSED for inclusion in the heptachlor/chlordane file.
   Therefore,  each region should prepare a Recall Final Report  (Exhibit
   14-E, Pesticides Inspection Manual) for each product subject to our
   recall request which was produced after July 29, 1975.  This report
   should be submitted to the appropriate Regional Coordinator no later
   than December 31, 1976.

      Recently the Court of Appeals for the D. C. Circuit  sxistained the
   Administrator's decision to suspend certain uses of chlordane and
   heptachlor  in all but one important respect.  (Environmental Defense
   Fund v.  EPA, No. 76-1247 (D.C. Cir., decided Nov. 10,  197ti)). With
   respect  to the Administrator's decision to allow use of existing stocks,
   the court remanded for reconsideration of sxich issues as amounts of
   existing stocks and the problems involved in their return or disposal.
   How the Agency will proceed in meeting the requirements of the
   remand  has not been determined.

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                              -2-

    Future surveillance for compliance with the Administrator's
order should bo routine except in the c^rsc of firms refusing to roc nil.
Additional visits to producers and/or distributors miry Je necessary
to assure compliance in these situations. Regarding enforcement
actions,  pending a final outcome on the issue of the remand, the fol-
lowing should be pursued. Any suspended hcptachlor/chlordane pro-
duct produced after July 29. 1975, and remaining in commerce  should
be stop saled.  Additionally,  since all but retail distributors should ,
have been notified to. return the violative products, any suspended
products found in channels of trade above the retail level should be
sampled and civil penalty actions issued to the distributor and/or the
producer, as appropriate. Civil penalty actions should also be.issued
for any violative samples  previously collected  above the retail level.
Beyond stop sale,-decisions on-the Ievel>*of'action'to"berapplied~a1rthe'^	
retail level are left-to regional discretion, though any repetition of
violation or evidence of bad faith should warrant civil penalty action.
This policy is reiterated now because a period of grace was previously
allowed for return or disposal of violative stocks.  Now that the recall
is complete and the suspension order close to a year old, such  leniency
is no longer appropriate.

    Finally,  in several instances recently, questions have aris'en con-
cerning indemnities.  The Agency's  position has been that such requests
pursuant to section 15 of the Act are inappropriate in the  absence-of a
final order of cancellation.  (See letter attached).

Enclosures:   ^

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          UNITED STATES ENVir.OriAflSNTAL PROTECTION /.".: :.;
                                                               /       /
                             120CT 1976
 Mr.  Kalpii Lii.i& 1'     ,  '
 executive Director
 Chemical  3p.-?ciii'i.ti2C r-ia
   Association; Incorporated
 1001 Connecticut Avenue, N.::.
 Suite 1120        
 Washington, . C.  '20036

 Doer Mr.  Cr.qel:

      Your letter of -August  30,  19"/G, hsc boon  reCerras  to
 this office vor re^ly..  because of. ttic .\irr.lnistrator' s
 OMooin-.T rwle  in tlie chlordan-r/heytacnlor prccesrtimis,  it  ,
 would }:2  ' inproocr under the  Agency's rules of  practice
 for  i'iinj to respond  to your  inquiry.
               "           "         *"            .  9 
            *'                                  
 f    Your letter asks that'ths  Ad^iniutratof  invokR  the '. .
 "special  rult"/unjter 515(b)(2), in order to allow  inv-an-
 tcries of chlor3ane products forsiulatoci between  July 29,-. ;
 1975, ana Dvscemier  2^, 19?r>, end currently on  dealer
 shelves,  to be sold until such. fctoc's: ore exhausted.
                                                        v  .
."     Vour request would-necessitate KO.Jificaticn o  the   
 order issued by the Administrator'on Oocewoer  24>  1975.
 Requests  tor such modifications must be wads  in  cont'orsancc
 v/ith the  roles of practice  set  forth in 40 CFR Part  164.
 be?*  especially 40 CFr< Io4.6(b), concerning 'enlargement of
 filing perioilsj 40 \CFU 164.31,  concerninq  intervention?
 cnJi  40 CTK IG/r.llO,' concernin-T po.ticns for reconsideration^
'of orders.        '                                 .
CONCURRENCES
id r
S.7NAM1 J>
turn {>
/i r>2-

1/7^/-)K
/A-*)^1-
t > ^/
ror^

^^ / 1 1*** i 










-,
.






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                             - 2 -


     finally,  candor  requires that I inform you that -the
Aqsncy statf woulci  oppose any suc:> .notion to modify tue* .
suspension order, snould one in fact.be filetf.  Essentially,
this is because  the suspension order is a temporary order,
which ultimately will be sneerceded, l.-y an order at the
termination of the  cancellation proceeding. .The question
of the extent' to which distriouticn 01! existing stocks ot
c.h .soi'a a no or octets  should be allowed can and should be
a'Jcrsssed in th cancellation procjetii'nc;, and resolved in
the order at tns conclusion of that proceeding.  Sound
considerations of procedure! man&qen'jnt militate against
interruption of  the cancellation proceeding to consider 
this question  at this time.      t
                               G.  '.fillLam Prick
                               General 'Counsel  (A-130)

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CHEMICAL SPECIALTIES MANUFACTURERS ASSOCIATION. INCORPORATED
            .t O'i C'..~  SIT.'C M2J  OCI COHNtCTlCUTAVE.. N.W.. WASHINGTON. D.C.2003C  (?02) 172-0110
      August 30, 197


      lir. RUE sell E. Train
      Administrator, EPA
      401 M Street, S.W. , Room W1200
      Washington, D.C. 20460

      Dear Mr. Train:

      On August 16, CSMA counsel Robert Ackerly and Roger
      Copland of my staff met with several Agency officials,
      including those from the Enforcement Division and the
      Office of General Counsel, to discuss the situation
      pertaining to products containing chlordane.

      Pursuant to that meeting,-I hereby request that you"
      invoke the Special Rule of 15(b)(2)  and allow inven-
      tories of chiordane products formulated between July 29,.1975
      and December 24, 1975 and currently- on dealer shelves to
      be sold until- such stocks are exhausted.

      There are several reasons for this request:

           1) Recall is in most cases a practical impossibility
              and constitutes an economic hardship, particularly
              to smaller forraulators.   There are literally thou-
              sands of small retailers who may have a few units
              of chlordane products in stock.  It is not always
              possible for the formulator to ascertain where
              such products are being sold.  If stocks are dis-
              covered, compliance with-' Department of Transpor-
              tation regulations governing the shipment of
              hazardous materials becomes a major problem,
              especially in view of the fact that substantial
              numbers of retailers will have only a few units
              of various brands.

           2)  Invocation of the Special Rule will not create a
              health hazard.   Use .of the products as directed
              may be the safest way of disposing of remaining
              stocks.   The remaining supply of chlordnne pro-
              ducts does not,  in relative terms, constitute a
              large amount.   We estimate that between 1,800,000

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                       -2-
   to.3,600,000  units  remain on the shelves of some
   75,000  retail dealers.  While the recall or stop-
   sale  of these units would have an adverse economic
   impact  on many  formulators, their normal, generally
   outdoor use would not significantly exacerbate a
   situation that  has  been ongoing for some 26 years.
   Furthermore,  we have heard that some dealers are.'
   simply  flushing unmarketable units away, thereby
   possibly creating a potential hazard more pro-
   nounced than  that created by accepted uses before
   suspension.   Indeed, safe disposal remains a pro-
   blem  for the  formulator.

3) There has been  some ambiguity concerning the sale
   of chlordane  that has left a number of formulators
   confused and  uncertain.  On July 29, 1975 you, in
   your Notice of  Intent to Suspend, announced that
   you were invoking the Special Rule for those pro-
   ducts formulated as of the date of the notice.
   We believe that this action should have been, taken
   when the registrations of chlordane for most uses
   was suspended on December 24, 1975.  Had you is-
   sued an  emergency'suspension order on July 29th,
   the Special Rule could ha~ve been" invoked.  By
   letter dated  September 23, 1975, the Office of
   General  Counsel indicated that the sale of pro-
   ducts formulated after July 29th was legal until
   final suspension decision was made.  On December 24,
   you suspended most  registrations and stated that
   products formulated after July 29th could not be
   sold.  On March 23, 1976 the Enforcement Division
   requested formulators to undertake a voluntary
   recall of products  formulated after July 29th.
   The net  effect of these actions has been to en-
   gender confusion-in many people over the mandatory
   nature of a ban on  sales.  While perhaps not de-
   cisive, xve believe  this factor should in good faith
   be considered.          ..-'.                     

4) Harassment of dealers by some Enforcement officials,
   especially in the Northeast,  has fostered resent-
   ment of the Agency  as a- whole and,  in some cases,
   strained relations along the distribution chain.
   The orderly sale of remaining inventories would-.
   reverse these counterproductive tensions.

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                           -3-
Of course, should you invoke the Special Rule, it would
alleviate indemnification problems that will "arj.se with
respect to products formulated prior to the Suspension
Order.                                 

I look forward to hearing from you concerning this impor^
tant matter.
Executive Director
KEtkas
cc:  A.E. Conroy

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            UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                        WASHINGTON. D.C. 20460
                                                  PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM

SUBJECT:  Revised Compliance Strategy for the Cancellation and
          Suspension of Chlordane and Heptachlor lern^ticides
FROM:     John J. Neylan III,  Director
          Policy and Grants Division
          Office of Compliance Monitoring

TO:       Addressees


     On February 23, 1987,  in  the case of the National  Coalition
Against the Misuse of Pesticides vs. EPA, the U.S.  District Court
ruled that the Agency's allowance of the continued  sale and use
of al1 cancelled chlordane  and heptachlor products  was  void,
and ordered EPA to take "whatever action is necessary  ...  so
that on and after April 15, 1988, sales, commercial  use,  and
commercial application of existing stocks of chlordane  and
heptachlor which have been  the subject of voluntary cancellation
shall cease..."  Since sale, distribution, and use  of  Velsicol's
chlordane and heptachlor products are already prohibited  after
April 15, 1988, the District Court Decision effectively only
applies to the non-Velsicol chlordane and heptachlor products
which have been voluntarily cancelled.

     In order to Implement  that Court Decision, on  April  5, 1988,
EPA issued a "Chi ordane/Heptachl or Termi tiddes; Notification
of Cancellation and Amendment  of Existing Stocks Determination."
That Notice informed the public that the registrations  of the
products listed 1n that Notice are cancelled (see Appendix C  for
this list), and that It is  a violation of the cancellation order
for any person to distribute,  sell, offer for sale, hold for  sale
deliver for shipment, receive  (and having so received)  deliver
or offer to deliver to any  person, or to make commercial  use  or
commercial application of those products after April 14,  1988.

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                               -2-
      In the spirit  of the  February 23, 1988 U.S. District
Court Order, on April 5, 1988, EPA also issued a "Chlordene/
Heptachlor Termiticides; Notice of Intent to Suspend Registrations
and to Place Limitations on Sale and Use of Existing Stocks".
All of the chl ordane/heptachl or termiticides affected by this
April  5, 1988 Suspension Notice were previously suspended and
issued Stop Sale, Use, or  Removal Orders (SSUROs) for failure
to respond to the FIFRA 3(c)(2)(B) Data Call-in.  However, the
limitations on sale and distribution of the previous suspension
and SSUROs only affected the registrants.  The recent April 5,
1988  Suspension Notice includes prohibitions on the sale,
distribution, and use of existing stocks of the suspended products
which  are similar to those imposed by the U.S. District Court
Order and the resulting Notification of Cancellation described
above.  That is, after the April  5, 1988 Notice of Intent to
Suspend becomes final and  effective, no person may distribute,
sell,  offer for sale, hold for s.-. 1 e, deliver for shipment,
receive (and having so received)  deliver or offer to deliver
to any person, or to make  commercial use or commercial  application
of suspended chlordane or  heptachlor products (see Appendix D).

      Please note that all  persons adversely affected by the April  i
1988  Suspension Notice may request a hearing within 30 days of
publication of the  notice.  The existing stocks provisions of
this  suspension notice which affect persons other than registrants
will  only take effect 30 days after the date of publication in
the Federal Reg i ster, or after completion of the suspension
hea rings, whi chever i s later.  OCM will inform the Regions when
the April 5, 1988 chl ordane/heptachl or suspension notice becomes
effect i ve.

     As stated in the April 5, 1988 Cancellation and Suspension
Notices, the prohibition on sale, commercial use and commercial
application applies to sales of chlordane and heptachlor
termiticides in any situation, and to all use and application
of such products in any situation, and to all use and applications
of such products with the  exception of use and application in
accordance with label directions by individuals (as opposed
to organizations, government agencies, corporations, etc.) on
property owned by tnose individuals.  However, this exception  for
individuals shall not apply to use or application by individuals
on property which is owned by them but which is rented or  leased
to others and is occupied  or intended to be occupied by human
beings, nor will it apply  to new structures under construction
for sale or lease.  Effectively, this means that the only
non-Velsicol chlordane and heptachlor termiticides that may  be
used  after April 14, 1988  are homeowner products used on  property
owned  and occupied  by the  individual user.

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                               -3-


     The attached Revised Compliance Monitoring Strategy for the
Cancellation and Suspension of Chiordane/Heptachlor Termiticides
is  identical to the January 29, 1988 strategy in regard to the
Velsicol products.  However, this revised strategy calls for
inspections of producing establishments, distributors/dealers/
retailers, and commercial users to assure that non-Velsicol
chlordane and heptachlor termiticides (i.e., both suspended and
cancelled) are not sold, distributed, or used in violation of
the April 5, 1988 Cancellation Notice and Suspension Order.
Inspections of distributors, dealers, retailers, and commercial
users to assure compliance with the chlordane/heptachlor suspension
and cancellation will  be conducted by States with Cooperative
Enforcement Agreements, and by EPA 1n States without Cooperative
Enforcement Agreements, as part of their routine inspections.

     The attached revised strategy also calls for a books and
records inspection of registrants of the suspended chlordane and
heptachlor termiticides to determine the first-line distributors
of those products.  The books and records inspection are to be
conducted by States, or Regions in States without Cooperative
Enforcement Agreements, within 60 days of the date of this strategy.
States conducting the books and records Inspections are to transmit
information on the first-line distributors to the Regions where
Stop Sale, Use, or Removal Orders (SSUROs) are to be issued to
those persons.  Regions are to transmit information on  first-line
distributors located in other Regions to those Regions.  Additionally
States and Regions are to Issue SSUROs to distributors, dealers,
retailers, and users of suspended chlordane/heptachlor products
as it is found during the course of routine inspections.  Please
note, registrants of the suspended products have already received
SSUROs in response to the previous FIFRA 3(c)(2)(B) suspension
action.  Therefore, sale and distribution of these products by
the registrant would be a violation of FIFRA 12(a)(2) (I).  Sale,
distribution, commercial use and commercial application of cancelled
chlordane and heptachlor termiticides is a violation of FIFRA
12(a)(2)(K).

    The attached revised strategy is effective Immediately and
replaces the January 29, 1988 strategy.  Please transmit a copy
of this strategy to the States within your Region immediately.
If you have any questions regarding the revised strategy, please
contact Dan Helfgott of my staff at FTS 382-7825.


Attachments

-------
                                 ADORES
       Douglas D. Campt
       Edwin  F. Tinsworth
       Frederick F. Stiehl
       Mark Greenwood
       A.E. Conroy II
       Connie Musgrove
       Ken Shiroishi
       Phyllis Flaherty
       John J. Neylan III
       Mike Wood
       Jerry  Stubbs
       Dexter Goldman
                     (TS-766C)
                     (TS-767C)
                     (LE-134A)
                     (LE-132A)
                     (EN-342)
      Jake Mackenzie
      Western Regional Compliance Director
I     Louis F. Gitto, Director
      Air Management Division

II    Barbara Metzger, Director
      Environmental Services Div

III   Stephen R. Wassersug, Director
      Hazardous Waste Management Div

IV    Winston A. Smith, Director
      Air, Pest. & Toxics Mangt. Div

V     William H. Sanders III, Dir
      Environmental Services Div

VI    William B. Hathaway, Dir
      Air, Pesticides & toxic Div

VII   William  A. Spratlin, Director
      Air and Toxics Division

VIII  Irwin L. Dickstein, Director
      Air and Toxics Division

IX    Jeffrey Zelickson, Director
cc:
                                 Marvin Rosenstein, Chief
                                 Pesticides & Toxic Substances  Br

                                 Ernest Regna, Chief
                                 Pesticides & Toxic Substances  Br

                                 Larry Miller, Chief
                                 Toxic & Pesticides Branch

                                 Richard DuBose, Chief
                                 Pesticides & Toxic Substances  Br

                                 Phyllis Reed, Chief
                                 Pesticides & Toxic Substances  Br

                                 Robert Murphy, Acting Chief
                                 Pesticides & Toxic Substances  Br

                                 Leo Alderman, Chief
                                 Pesticides & Toxic Substances  Br

                                 Alvin Yorke, Chief
                                 Toxic Substances Branch

                                 Davis Bernstein, Chief
      Toxics and Waste Management Div  Pesticides  &  Toxics  Branch
      Gary O'Neal, Director
      Air and Toxics Division
                                 Anita Frankel, Chief
                                 Pesticides  &  Toxic Substances Br
Michael Walker
Jane Hopkins
Margaret Rostker
Phil Gray
(LE-134P)
(TS-788)
(TS-788)
(TS-766C)

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                                                                3 ;g&
                             REVISED
      COMPLIANCE STRATEGY FOR THE CANCELLATION AND  SUSPENSION    3
               OF CHLORDANE/HEPTACHLOR TERMITICIDES

 OVERVIEW

      This Strategy calls for monitoring compliance with  the
 August  11,  1987 Memorandum of Understanding (MOU)  between the
 agency  and  Velslcol Chemical Corporation, the October 1,  1987
 cancellation of Velsicol's chlordane and heptachlor termiticides,
 the April 5, 1988 "Chiordane/Heptachlor Termiticides; Notification
 of Cancellation and Amendment of Existing Stocks Determination",
 and the April 5, 1988 "Chiordane/Heptachlor Termiticides; Notice
 of Intent to Suspend Registrations and to Place Limitations on
 the Sale and Use of Existing Stocks."

      Inspections will be conducted by  States with  Cooperative
 Enforcement Agreements, and by EPA Regions in States without
 these agreements, at the registrant, distributor/dealer/retailer,
 and user level in accordance with the  neutral administrative
 inspection  scheme outlined in this Strategy.  Stop Sale,  Use, or
 Removal Orders (SSUROs) are to be issued to any person who sells,
 distributes, or makes commercial use or commercial application
 of suspended chlordane or heptachlor products after the  effective
 date  of the April 5, 1988 suspension notice (see Appendix D for
 the list of these products).  Civil penalties are  to be  assessed
 against registrants, who have already  received a SSURO,  and who
 sell   or distribute suspended chlordane/heptachlor  products (see
 Appendix E  for the 11st of registrants who have received SSUROs).
 Finally, SSUROs will be Issued, and civil penalties will  be
 assessed to any person who sells, distributes, or makes  commercial
 use or commercial application of any chlordane/heptachlor termiticide
 in violation of the October 1, 1987 or April 5, 1988 cancellation
 orders  (see Appendix C for 11st of cancelled products).

 BACKGROUND

     On August 11, 1987, the EPA and Velslcol Chemical Corporation
entered into a Memorandum of Understanding (MOU) in which Velsicol
agreed to Immediately discontinue the  sale and distribution of all
 of its termiticide products containing chlordane or heptachlor.
Persons other than Velslcol were not affected by this agreement, and
were  therefore not prohibited from sale, distribution, or use of
existing stocks of Velslcol's termitlddes under existing labeling.

    Under the terms of the MOU, EPA also granted Yelslcol a
conditional  registration for certain uses of some of Velsicol's
 chlordane and heptachlor products.  Velslcol may only distribute
 these conditionally registered chlordane/heptachlor  pesticide
 products as Restricted Use Pesticides  1f air monitoring  tests
 reveal zero exposure from each use, an"3~provi ded certain  uses,
 such  as use Inside the home and high pressure injection,  remain
deleted from the label ("deleted uses",  see Appendix A for deleted
and retained uses).  Regions and States will be notified  if  and
when  Yelsicol has met the terms of the conditional  registration,
and therefore, when Velslcol may resume Its sale of  chlordane
and heptachlor products.

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                               -2-


     On October  1,  1987, Velsicol agreed to voluntarily  cancel
 its  chl ordane/heptachlor termiticide products which  were not
 conditionally registered pursuant to the MOU.  The  October  1,  198
 Cancellation Order  was  published in the Federal  R *i stej" o n
 November 3, 1987  (52 FR 42145).  Under the Cancel .tion  Order,
 Velsicol was still  prohibited from the SG e and distribution  of
 its  chlordane/heptachlor termiticides; hooever,  existing stocks
 provisions were  established which phased cut sale,  distribution,
 and  use of Velsicol's chlordane/heptachlor termiticides  by  persons
 other  than Velsicol.  Between December 1, 1387 and  April 15,  1988,
 stocks of Velsicol's chlordane/heptachlor termiticides may  be
 ;,ld,  distributed,  and  used by persons other than Velsicol  as a
 Restricted Use Pesticide (RUP), and only in accordance with
 the  use directions  found in the Cancellation Order.   No  sale,
 distribution, or  use is to be permitted after April  15,  1988.

     On April 5,  1988,  EPA issued a "Chlordane/Heptachlor
 Termiticides; Notification of Cancellation and Amendment of
 Existing Stocks  Determination".  That notice informed the public
 that,  after April 14, 1988, no person may distribute, sell,  offer
 for  sale, hold for  sale, deliver for shipment, receive (and having
 so received) deliver or offer to deliver to any person,  or  to
 make commercial  use or  commercial application any non-Velsicol
 chlordane or heptachlor product which has been cancelled (see
 Appendix C for a  list of these products).

     Also on April  5, 1988, EPA issued a "Chlordane/Heptachl or
 Termiticides; Notice of Intent to Suspend Registrations  and to
 Place  Limitations on Sale and Use of Existing Stocks".  All  of
 the  chlordane/heptachlor termiticides affected by that Notice were
 previously suspended and issued Stop Sale, Use, or Removal  Orders
 (SSUROs) for failure to respond to the FIFRA section 3(c)(2)(B)
 Data Call-In.  However, the limitations on sale and distribution
 of the previous  suspension and SSUROs only affected the registrants.
 The April 5, 1988 Suspension Notice includes prohibitions on the
 sale,  distribution, and use of existing stocks of the suspended
 products which are  similar to those imposed  by the U.S.  District
Court  Order and  resulting Notification  of Cancellation  described
above.   That 1s,  after  the April 5, 1988 Suspension Notice  becomes
final  and effective, no person may distribute, sell, offer for
sale,  hold for sale, deliver for shipment, receive (and having
 so received) deliver or offer to deliver to  any  person, or to
make commercial  use or  commercial application of suspended chlordane
or heptachlor products  (see Appendix D).

     Please note  that while the original Suspension Orders which
 affected only registrants remains in effect, all persons adversely
affected by the April 5, 1988 suspension notice  may request  a
hearing within 30 days  of publication of that notice.   The   xisting
 stocks  provisions of the April 5, 1988  Suspension Notice wh  ^h
affect  persons other than registrants will only  take  affect  30
days after the date of  publication 1n the Federal Register,  or
after  completion  of the suspension hearings, whichever  is later.
OCM will  inform  the Regions when the April 5,  1988 chlordane/
heptachlor Suspension Notice becomes  effective.

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                               -3-
 REGULATtD  INDUSTRY
     The  sole producer of technical chlordane and heptachlor  in  the
 United  States 1s Velsicol Chemical Corporation.   The October  1,  1987
 cancellation order affects registrants [i.e., Velsicol  and its
 supplemental registrants (see FIFRA Compliance Program Policy
 No. 3.9)],  distributors/dealers/retailers, and users of Velsicol's
 chlordane/heptachlor.  The October 1, 1987 cancellation order
 does not  affect non-Velsicol chlordane and heptachlor termiticides.

     The  April 5, 1988 chlordane/heptachlor cancellation notice
 affects registrants (effectively, only the non-Velsicol registrants
 of  chlordane and heptachlor termiticides), distributors/dealers/
 retailers,  and commercial users and commercial applicators of
 cancelled chlordane and heptachlor products (see Appendix C).
 The April 5, 1988 chl ordane/heptachl or suspension notice affects
 all registrants (again, the non-Velsicol registrants), distributors/
 dealers/retailers, commercial users and commercial applicators
 of  chlordane and heptachlor products which have already been
 previously  suspended because the registrant failed to submit
 data to the Agency pursuant to the FIFRA section 3(c)(2)(B)  Data
 Call-In (see Appendix D).

     Please note that for purposes of the April 5, 1988 chlordane
 and heptachlor suspension and cancellation notices, the prohibition
 on  sale,  commercial use and commercial application applies to
 sales of  chlordane and heptachlor termiticides in any situation,
 and to  all  use and application of such products with the exception
 of use  and  application in accordance with label directions by
 individuals (as opposed to organizations, government agencies,
 corporations, etc.) on property owned by those individuals.
 However,  this exception for individuals  shall not apply to use
 or application by individuals on property which is owned by them
 but which is rented or leased to others  and is occupied or intended
 to be occupied by human beings, nor will it apply to new structures
 under construction for sale or lease.  In short, this means  that
 the only non-Velsicol chlordane and heptachlor termiticides  that
may be  used after April 14, 1988, are homeowner products used on
 property owned and occupied by the individual user.


 REQUIREMENTS OF THE AUGUST 11, 1987 MEMORANDUM OF UNDERSTANDING

     As per the August 11, 1987 MOU, Velsicol may not  sell or
 distribute any of its chlordane/heptachlor termiticides after
August  11,  1987.   Products that remain conditionally registered
may only be sold and distributed by Velsicol  when the  terms  of
 the conditional  registration are met (OCM will Inform  the Regions
when this occurs).  Other persons (i.e., distributors/dealers/
 retailers,  users,  and non-Velsicol registrants) were not  affected
by this agreement.

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::^ IH
Register /  Voi  52  No. 2:2  '  Tupsd.i>. N'ov.'-.!>pr  3.  196?  / Noiir.rs
 -:  -  -   T.t :!-.! the en;..:
       . - :'-:. s  :
  ' : ;   ..  '  -<<,: all bi- mncc \\ith
   ;.' y ., ti..i:-. 50 p s ; at the
   :'- .''.' .i -.2 i rca-sf spray nozzle
    '   : ''.u*,i;.,'-.r.;; horizontal b.irruvs
 '.: i '  '.rrt v sij^s cannot be poured
   t!J;.-.2 'he ..utr.io. jM'vrruivr.
                                         USP low pri *VJ:P (ii s.5 I"-..-IT: Tj p s.i L!
                                         the ncrrit!
                                       Trenches nerd not lip \vi ier tri..n f>
                                         inches nor below thi- foot.rg  Thn
                                         emulsion should be mixed w;th thr
                                         soil as it is being repluced in  the
                                         trench. Cover the treated soil with
                                         approximate^ 2 inches of untreated
                                         soil.
                                       A complete termite barrier may
                                         require treatment with another EPA-
                                         registered product to the inside
                                         perimeter of the foundations  and to
                                         other in:.nor critical areas.
                                       Basement Fourdjlions
                                       Horizontal Darners
                                         After exterior grading is completed
                                       and prior to the pouring of concrete
                                       slabs, horzor.u! barriers may be
                                       estaLlibhed or. soil whic.'i will be
                                       covered by concrete entrance platforms.
                                       and in othr: exterior critical areas
                                       which w-.'n be covered by concrete slabs.
                                       To produce a .-.onzontal barrier, apply
                                       the emulsion at the rate of 1 gal!" per
                                       10 square fee! to fill dirt. If fill is washed
                                       pruvcl or other coarse me'.crial. apply at
                                       1'/: gallons per 10 square feet.
                                       It is irrpr -tj.-.t that the emulsion
                                         renchcs  :L.c son
                                       Applications shall be made (w.'.h
                                         pressures less than 50 p.s.i. c! the
                                         nozzle) us;n; a course spray  nczzic
                                         when establishing horizontal barriers.
                                       If concrete slabs cannot be poured
                                         over soil the same day it has been
                                         treated,  a water-proof cover, such as
                                         polyethylene sheeting, should be
                                         placed over  the soil to prevent
                                         erosion.
                                       Do not apply to any area inside the
                                         foundation wall.
                                       Vertical Barriers
                                         After the final exterior grading is
                                       completed, vertical barriers nav be
                                       created in back-filled soil against
                                       foundation walls. To produce a vertical
                                       barrier, apply the emulsion by  low
                                       pressure roddmg or trenching at the rate
                                       of 4 gallons per linear feet per foot of
                                       depth from grade to the top of the
                                       footing.
                                       Low pressure rodding and/or
                                          trenching applications should not be
                                          made below the top of the footing
                                          except when the footing is exposed at
                                          or above grade. Special care should
                                          be taken to avoid soil washout around
                                          the  footing
                                       When rodding.  use low pressure (less
                                          thnn 25  p.si at the nozzle). It is
                                          important tht enulson roaches the
                                          footing.  Rod holes should be sp;it.nd to
                                          provide a continuous bhrrier.
                                                      Trenches need nc! be w.Jcr than C
                                                       inches.
                                                      Emulsion should bo m:\cd w:;h, :!-c
                                                       soil as it is b^ing repinccd in thr
                                                       trench. Cover treated se;l wiih
                                                       approx.nidtcly 2 inches of
                                                       soil.
                                                     Dilution Instruction fcr Gold Crest
                                                     Termale

                                                       Use a .75rt xvater emulsion for
                                                     subterranean termites other than
                                                     Cop'.aterrr.cs spp. Mix 1 gallon of Gold
                                                     Crest Tcrmide in 99 gallons of water to
                                                     produce at 0.75"i water emulsion. Uce a
                                                     0.75-1.5% water emulsion for
                                                     Coptoterrr.es spp. where necessary. Mix
                                                     1-2 gallons of Gold Crest Terrnide in 90
                                                     gallons of water to produce a 0.75-1.5%
                                                     water emulsion.

                                                     Dilution Instructions for Gold Crest ClOO
                                                     and Chlordane 8EC/Termite

                                                       Use a 1% water emulsion for
                                                     subterranean termites other than
                                                     Coptc'.emes spp. Mix l gallon of
                                                     product in 95 gallons of water to
                                                     produce a 1% water emulsion. Use a 1-
                                                     21 water emulsion for  Coptote.-mes spp.
                                                     where necessary. Mix 1-2 gallons of
                                                     product in 95 gallons to produce a 1-2%
                                                     emulsion.

                                                     Dilution Instruction for Gold Crest H-60

                                                       Use a .5" water emulsion for
                                                     subterranean termites  other than
                                                     Crptotermes spp. Mix  1 gallon of
                                                     product in 59 gallons of water to
                                                     prodcue a .5% water emulsion. Use a 1%
                                                     water emulsion for Coptoterrr.es spp.
                                                     where necessary. Mix  2 gallons of
                                                     product in 59 gallons of water to
                                                     produce a 1% water emulsion

                                                     Dilution Instruction for Gold Crest C-50

                                                        Use a 1% water emulsion for
                                                     subterranean termites other than
                                                     Coptotermes spp. Mix 1 gallon of
                                                     product in 47 gallons of water to
                                                     produce a 1% water emulsion. Use a 2%
                                                     water emulsion for Coptotermes spp.
                                                     where necessary. Mix 2 gallons of
                                                     product in 47 gallons of water to
                                                     produce a 2% water emulsion.
                                                        Do not  apply this produce into hollow
                                                     masonry  voids.
                                                        Do not  apply this product to soil
                                                      beneath the interior of the structure. Do
                                                      not apply to the soil beneath a plenum
                                                      air space.
                                                        Do not  apply emulsion until location
                                                      of pipes,  water and sewer lines and
                                                      electrical conduits arc known and
                                                      identified.

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                                       Vn!.  52
                   Tt;.
                                                                                                               421-1 <"!
.i:*!:i.-rl,.>n
  V.f. .,: l..ir::rr:, rr..v. V' , vi.,1.1.,11, J
.ii.ii;a :r>i' o'.ijidf of Ihc fi'.ni.ljlion bv
I iv (jri-s .;: ruUiiniR Jiul/or irr.nchin,;
.it ihi- rjii- of 4 g.iilon-. of emulsion per
in urn .1: fprl  I .cm press, no rncljir.^
 .".iv,;!J nut cxicnd beyond Sin.- Icpr. nf
I.M- f,...-:r.cs
 V, i. en loddmg. use on!> low pressure
  (Irss ;nan 25 p.s.i at the nurzie).
 IJriil holes m ou'.s:de slabs (patios.
  sidc-\\a!ks. etc ) nbout 12 to 30 inchns
  up.iri iu prov :eie a  continuous
  <:hcm-< ,\', bnrncr.
 ! 'or sr.iiiow foundations. 1 fool or
  less. d:p a narrow  trench
  ;:pp.-cx:mate!y six inches wide along
  the outside of the foundation walls.
  Do not trench brlow the bottom of the
  foundation The emulsion should be
  Jipp'ieJ to the Irene!, and t!ie soil at 4
  gallons per TO linear feet as the soil is
  replaced in the trench. Cover the
  trc.it-d soil with approximately 2
  inches of  untreated soil.
 For foundations deeper than 1 foot
  npply 4 gallons per 10 linear feet per
  foot  of depth.
U.:. be applied only
by triT.chir.B or the exravation
technique below ct a rn!e of 4 gallons of
r.-p.u'sion per 10 hnt^r feet per foot of
depth to he treated. Where exterior
s,.,!is arc odjacent to the foundation
wall, drill through the slab along the
outside of the wall at a spacing that
provides application of a  continuous
b.irrrr and apply the emulsion just
under the slab. After drilling, emulsion
may be applied. Apply only at the
lowest pressure that will start the flow
of emulsion from an unobstructed rod.
Apply up to 4 gallons of emulsion per 10
linear feet.
  A ccrr.plete termite barrier may
require application of another EPA-
registered product under interior slabs.
through hollow masonry voids to the
footing, and to other interior critical
areas.
Excavation Technique
  If treatment is to be made in difficult
situations such as near weJls or cisterns.
along faulty foundation walls, and
around pipes and utility lines which lead
downward from the structure.
application must be made in the
following manner to avoid intrusion of
termiticidc into water supplies or the
interior of the structure.
 Trench and remove the scil to be
  treated only heavy plastic sheeting or
  similar liner.
 Treat the soil at the rate of 4 gallons
  of emulsion per 10 linear feet per foot
  of ilc;';h :if |S- tr^n'-i;. Mix l!ic
  C'J'iiUmii imrT.ijjHy irvo ;he *"!
  l.iK.:'i. i .ite '.. ;  i v i:nt li^LiiJ f..in
  rnr.:-..:-.!; ,,-ff i;  lir.i r.
After i'ii' '.riM'.Ld so:: hjs ciru d
  .iJotjii.ili-';..  ri'cljo- li.t .ml ,n ll.r
  triT.i.h and tuver w;:h ;ipi'roMn..ii:ly
  2 :nchrs of ontrcalcd soil.
fiL-t.-catmrn: Restrictions
  Retreatmcnt for subterranean termites
should onk be made when there is
evidence of reinfcstation suh.scqvient to
thu initial treatment, or thcrp has been
disruption of the chemical barru.-r in the
soi! due to construction, excavation.
landscaping, etc. Keireatment should be
made as a spot appiicntion tc these
areas.
  Re'.rentmcnts may be made to critical
ureas in accordance with the application
techniques described above. This
application should be made as a spot
treatment to these areas. Do not
annually retreat entire  premises.
  Copies of the August 11.1987.
agreement and the October 1.198".
supplementary agreement between EPA
and Vclsicol. can bo obtained from the
person listed under FOR MORE
INFORMATION CONTACT:
  Dated: Ociuber 23. 1SGT.
Douglas D. Campl.
Director. Or?:Ce ofF?slicnlrPrvgrcm:.
|FR Doc. 8r-25383 Fiic-d n-2-8T. 6.45 amj
ILUHC COOC IMO-90-U

IOPP-180747; FRL-3286-S)

California Department of Food and
Agriculture; Receipt of Application for
Emergency Exemption To Use
Hydrogen Cyanamlde; Solicitation of
Public Comment

AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice.	

SUMMARY: EPA has received a request
for an emergency exemption from the
California Department of Food and
Agriculture (hereafter referred to as the
"Applicant") to use the active ingredient
hydrogen cyanamide ("Dormex") to
promote uniform bud break in 18.800
acres of table grapes grown in the
Coachella Valley in Riverside County.
California. Dormex contains an
unregistered active ingredient and.
therefore, in acordance with 40 CFR
166.24. EPA is soliciting comment before
making ' "e decision whether or not to
grant the exemption.
DATE: Comments must be received on or
 before November 10.198?.
ADDRESSES: Three  copies of written
comments, bearing the identification
ni-l.i!:,.:  OIT. 1 111-4-. ' o.  .:.!
Mi!. Pi.;-. ,! .;\  r;.i . :.  I: :  : i-
S.TV.. . , S. >.: ..... I'r.if ... M .-
unJ S,.; ; -i\\ U.\ :.i.ir i lv>-"d"v.
of IVMn ..... lri..-i_n-.> K..\I:.-I.
W.is!;;!i'.-.-.i.. H.C ^
  In pcion. bnrig corrirr.i-i'.ts lJ. R:n l.io
Cr\st.il Mai! =2. 19C1 jpffcr^in U..MS
Hiyhwdy. Arlington. VA.
  Inform. ition submitted in ;i.-.y
commnnt TDncerning ilns notice r.-..iy i'C
rluimed confidential by m;irking any
part or all of that informal ;on as
"Confidential  Business l.-.farrr.utio^
(CBI)." Information so marked wiii r.oi
be disclosed except in accordance v.::h
procedures  set forth in 40 CFR Part ". A
copy of the  comment thnt dors contain
CBI mus! bo subn-.i!!ed for ::%.cLs;o:: ~.
the public record. Information not
marked confidential may be disclosed
publicly by  EPA without prior nc:;co tc;
the submitter. All written comments w:ll
be available for inspection in Rm. 230 d'.
the address given above from 8 a.m. to 4
p.m.. Monday through Friday, excluding
lega! holidays.
FOR FURTHER INFORMATION CONTACT:
By mail: Litiuy Pemberton. Rig:stratior.
Division (TS-767C). Office of Pesticide
Programs. Environmental Protccticr.
Agency. 401 M Street. SW.. VVashinpio.-..
DC 20460.
  Office location end telephone P.LT.I
Rm. 716. Crystal Mull ~2. 192:
Davis Highway. Arlington. VA.
557-1806).    "
SUPPLEMENTARY INFORMATION: Pur.-.uar.t
to section 18 of the Federal Insectir.Je.
Fungicide, and Rodcnt:cide Act (FIFRAJ
(7 U.S.C. 136p). the Administrator may.
at his discretion, exempt a State agency
from any provisions of F1FRA if he
determines that emergency conditions
exist which require such exemption.
   The Applicant has requested the
Administrator to issue a specific
 exemption  to permit the use of an
 unregistered plant regulator, hydrogen
 cyanamide (CAS 420-04-2).
 manufactured as Dormex. by SK'.V
 Trostberg Aktiengesellschaft. tc prsrncte
 uniform bud-break in table grapes
 grown in the Coachella Valley in
 Riverside County.  California.
 Information in accordance with 40 CFR
 Part 166 was submitted as part of this
 request.
   Approximately 18.800 acres  of tobie
 grupes. Vitts spp..  are grown in the
 Coachella Valley.  The Applicant
 indicates thai California growers rf   '
 early market table grapes are f:ic:r;
 economic losses due to increasing
 competition from fore:pn irrpcrts.
 particularly from Me.vco. The

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                              -4-


 REQUIREMENTS OF THE OCTOBER 1. 1987 CANCELLATION ORDER

      The registrations of Gold Crest Termide, Gold Crest  C100,
 and  Chlordane SEC Termite were amended by splitting each  registration
 into  two separate registrations.   A new EPA registration  number
 was  assigned for each of the above End Use products for the uses
 described in Appendix A as "retained uses".  The remaining uses
 for  each of the above products maintained their current EPA
 registration numbers of 876-233,  876-63, and 876-104 respectively.

      The registrations of Gold Crest Termide, Gold Crest  C100,
 and  Chlordane 8EC Termite, which  have maintained their  current
 EPA  registration numbers of 876-233, 876-63, and 876-104  have
 been  voluntarily cancelled effective September 30, 1987 along
 with  the following Velsicol products: Gold Crest C-50 (876-86),
 Gold  Crest H-60 (876-85), California SLN for crawlspace perimeter
 spray  (Termide) (CA-810012), California SLN for crawlspace
 perimeter spray (C-100) (CA-810012), and Hawaii SLN for crawl-
 space  perimeter spray (C-100) (HI-850003).  The cancellation
 order  also affects Velsicol 's supplementally distributed  products
 (the  list of supplemental registrations are in Appendix B).

      The Gold Crest Termide, Gold Crest C100, and Chlordane
 SEC  Termite products which bear the "retained uses" and have
 been  assigned new EPA registration numbers are not cancelled.
 These  products continue to be conditionally registered  with
 EPA  but may not be sold and distributed by Velsicol until the
 terms  of the conditional registration, as outlined in the
 August 11, 1987 MOU, are met.  Additionally, the cancellation
 does  not affect the following Velsicol Chlordane and heptachlor
 products:  Technical Chlordane/ Export (876-280); Technical
 Heptachlor/Export (876-288); and  Technical Heptachlor/Formulation
 of Fire Ant Granular for Cable Closure Only (876-330).   Please
 note,  as per the MOU, except for the Technical Heptachlor/Formulation
 of Fire Ant Granular for Cable Closure, none of the above products
may be sold or distributed by Velsicol in the United States even
though they have not been cancelled.

Existing Stocks for Velsicol 's Chiordane/Heptachlor Termiticides

     As per the October 1, 1987 cancellation order, persons
other  than Velsicol [and its supplemental  registrants(see 40 CFR
 162.6(b)(4)(1 i 1)] may sell, distribute, and use existing  stocks
of Velsicol's Chlordane and heptachlor products in any manner
consistent with the existing labeling until November 30,  1987.
From December 1, 1987 until April 15, 1988, Velsicol's Chlordane
and heptachlor termiticide products will  be restricted use  pesticides
for retail  sale to and use only by certified  applicators  or
persons under their direct supervision.   Between December  1, 1987
and April  15, 1988, certified applicators, or  persons  under
their  direct supervision, are required to  use  Velsicol's  Chlordane
and heptachlor products in accordance with the  use directions
found  in the cancellation order (52 FR 42145;  November 3,  1987).
Sale,  distribution, and use of such Chlordane  and  heptachlor
products will  not  be permitted after April 15,  1988.

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                               -5-


      Please note, the directions for use found in the cancellation
 order cannot be considered "labeling" unless they accompany  the
 product.  There 1s no requirement in the cancellation order  that
 these directions for use accompany the product.   Therefore,  between
 December 1, 1987 and April 15, 1988, unless the  directions for
 use  found in the cancellation order accompanied  the product  at
 the  time of sale, use of Velsicol's chlordane and heptachlor
 products not in accordance with the revised use  directions must
 be considered a violation of the cancellation order and not
 "misuse."  Additionally, unless Velsicol's chlordane and heptachlor
 products have been sold with the revised use directions, sale to
 or use by uncertified persons will be a violation of the cancellation
 order and not a violation of FIFRA 12(a)(2 ) (F ).

 REQUIREMENTS OF THE APRIL 5, 1988 NOTIFICATION OF CANCELLATION

     The April  5, 1988 Notice of Cancellation announces the
 cancellation of the chlordane and heptachlor products listed
 in Appendix C,  and establishes limitations on the sale and use
 of existing stocks of these products.  Please note, the products
 affected by this notice were previously voluntarily cancelled at
 the  request of the registrant.

 Existing Stocks	

     It is unlawful for any person to distribute, sell, offer
 for  sale, hold for sale, deliver for shipment, or receive (and
 having so received) deliver or offer to deliver  to any person,
 or to make commercial use or commercial application, cancelled
 chlordane and heptachlor termiticides after April 14, 1988.

 REQUIREMENTS OF THE APRIL 5, 1988 NOTICE OF INTENT TO SUSPEND

     The April  5, 1988 Notice of Intent to Suspend will suspend
 the products listed 1n Appendix D of this  strategy for continued
 failure to submit data within the time periods required by the
 chlordane and heptachlor Data Call-In, as  contained in the December
31, 1986 Chlordane and Heptachlor Registration Standards.  All
products affected by this Notice have previously been suspended
for failure to  commit to comply with the terms of that Data Call-In.
However, the previous chlordane/heptachlor suspensions did not
place prohibitions of the sale or use of existing stocks  of
suspended products by persons other than the registrant.  Any
suspensions resulting from the April 5, 1988 Notice of Intent to
Suspend will  include prohibitions on the sale and use of  existing
stocks of suspended chlordane and heptachlor termiticides.

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                               -6-
Exi sting Stocks
     When  the April 5, 1988 Notice of Intent to Suspend  becomes
final and  effective for a particular product listed  in Appendix D
(either 30 days after publication in the Federal  Register  or
upon completion of a suspension hearing) no personmaydTstribute,
sell, offer for sale, hold for sale, deliver for shipment,  or
receive (and having so received) deliver or offer to deliver to
any person, or to make commercial use or commercial  application,
suspended  chlordane and heptachlor termiticides.

COMPLIANCE MONITORING

     Conformance with the August 11, 1987 MOU will  be determined
through inspections of Velsicol's establishments to  determine
whether any stocks of chlordane or heptachlor were  sold  or
distributed after August 11, 1987.  Please note, there is  no
violation  under FIFRA for not conforming with the terms  of an
MOU, however, the Agency would like assurance that  the terms of
the MOU have been met.

     Compliance with the October 1, 1987 Cancellation Order
and the April 5, 1988 Notice of Cancellation and Notice  of
Intent to  Suspend will be determined through inspections of
producing  establishments, distributors/dealers/retallers,  and
users of chlordane and heptachlor termiticides.  Noncompliance
with the October 1, 1987 Cancellation Order or the  April 5, 1988
Notice of  Cancellation is a violation of FIFRA sections  12(a)(l)(A)
and 12(a)(2)(K).

     The Agency, and States with authority, are to  issue Stop  Sale,
Use, or Removal Orders (SSURO) to any person who distributes,  sells
offers for sale, holds for sale, ships, delivers for shipment, or
receives and (having so received) delivers or offers to  deliver
chlordane  and heptachlor termiticides other than in accordance
with the October 1, 1987 Cancellation Order and the April  5,  1988
Notice of Cancellation and Notice of Intent to Suspend.

Neutral  Administrative Inspection Scheme (NAIS)	

     Except for the Initial inspections of Velsicol's establish-
ments, all  Inspections for violations of the October 1,  1987
Cancellation Order will take place as part of  the Regions' and
States'  routine Inspections.  Inspections  of Velsicol's  producing
establisments to assure conformance with the MOU and compliance
with the October 1, 1988 Cancellation Order are to take  place by
April  29,  1988.

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                               -7-
      Inspections of distributors/dealers/retailers,  and commercial
 users  to assure compliance with the April  5, 1988 Notice of Intent
 to  Suspend will also  take place as part of the Regions and States
 routine inspections.  However, within 60 days of the date of
 this  strategy, States, or Regions in States without  Cooperative
 Enforcement Agreements, are to also conduct a books  and records
 inspection of  registrants of the suspended chlordane and heptachlor
 termiticides to determine the first-line distributors of those
 products.  States conducting the books and records inspections are
 to  transmit information regarding the first-line distributors to
 the Regions.   Upon receipt of this information,  Regions are to
 issue  SSUROs to those persons identified as first-line distributors
 in  their Region.  Regions are to transmit information on first-line
 distributors located  in other Regions to those Regions, where the
 SSUROs are to  be issued.  Additionally, States and Regions are to
 issue  SSUROs to distributors, dealers, retailers, and commercial
 users  of suspended chlordane/heptachlor products as  they are
 found  during the course of routine inspections.   Compliance with
 the SSUROs will be monitored in accordance with the  Pesticides
 Inspector's Manual .
as
  Regions/States will  also investigate all  tips  and  complaints,
appropriate.
     Please note, registrants of the suspended products have already
received SSURO's in response to the previous FIFRA S3(c)(2)(B)
suspension action.  Therefore, sale and distribution of these
products by the registrant would be a violation of FIFRA 12(a)(2)(I)
Sale, distribution, commercial use and coir.mercial  application of
cancelled chlordane and heptachlor termiticides is a violation
of FIFRA 12(a)(2)(K).

Registrant/Producer Level	

     By April  29, 1988, the Agency/States will schedule and
conduct Inspections of Velsicol's establishments to obtain
assurance that Velsicol has complied with the October 1, 1987
Cancellation Order by not having released products for shipment
after October 1, 1987.  At this inspection the Agency/States
will  also obtain assurance that Velsicol has abided by the
terms of the August 11, 1987 MOU by not having released the
affected products for shipment after August 11, 1987.

     Within 60 days of the date of this strategy, the Agency/
States will  conduct a books and records Inspection of the non-
Velsicol chlordane/heptachlor registrants to determine the  first-
line  distributors of those products.

     During the course of routine inspections, the Agency/States
will  obtain assurance that non-Velsicol registrants/producers
have  not sold or distributed their chlordane/heptachlor products
in violation of the cancellation orders, suspension orders,  or
SSUROs.

-------
                               -8-
Di:tributor/Dealer/Retall Level

     After November 30,  1987, when conducting routine inspections
at  the distributor/dealer/retail level, inspectors  will  check  to
determine whether Velsicol's chlordane and heptachlor termiticide
proc :ts are being sold  and distributed in accordance with  the
Octooer 1, 1987 Cancellation Order.

     After April 15, 1988, when Agency/States conduct routine
inspections at  the distributor/dealer/retail  level, they will
assure that remaining stocks of cancelled chlordane and  heptachlor
termitic ides are not being sold.

     After the  effective date of the suspension order, the  Agency/
States will conduct routine inspections at the distributor/dealer/
re-ailer level  to assure that remaining stocks of suspended chlordane
ana heptachlor  termiticides have not been moved and are  not being
sold.

User Level
     During routine use inspections prior to April  15,  1988,
inspectors will assure that Velsfcol's chlordane and heptachlor
is being used only by certified applicators and in accordance
with the use directions found 1n the Cancellation Order.

     After April 15, 1988, during routine inspections at the
user level, Agency/States will assure that any remaining stocks
of Velsicol chlordane and heptachlor are not being used,  and
remaining stocks of non-Velslcol cancelled chlordane and heptachlor
products are not being used for purposes of commercial  use or
commercial application.

     After the effective  date of the suspension order,  and during
routine inspections at the user level, the Agency/States will
assure that remaining stocks  of suspended chlordane and heptachlor
are not being used for commercial use or commercial appUca:  on.
ALLOCATION OF RESPONSIBILITIES
Office of Pesticide Programs
  Will develop and provide OCM with a list of those products
  which have been cancelled/suspended.

  Will notify OCM when registrants of suspended chlordane :nd
  heptachlor products  agree to voluntarily cancel their  , oducts.

  Will notify OCM 1f and when Velsicol has met the terms  of the
  conditional registrations of Gold Crest Termite, Gold  Crest C100,
  and Chlordane *EC Termite, and  therefore when these  products
  may be sold and distributed.

-------
                              -9-


Office of Compliance Monitoring
 0 Will develop and transmit the Compliance Monitoring  Strategy
  to the Regions.

 0 Will issue SSUROs for non-Velsicol  chlordane/heptachlor
  termiticides suspended under FIFRA  3(c)(2)(B).

 0 Will transmit to the Regions the list of those  products
  which have been cancelled pursuant  to the October  1,  1987
  Cancellation Order,  cancelled as specified in  the  April  5,
  1988 notification, or suspended pursuant to the  April  5,
  1988 Notice of Intent to Suspend.

 0 Will transmit a list of establishments  producing Velsicol's
  chlordane and heptachlor termiticides to the Regions.

 0 Will notify the Regions if and when Velsicol  has met the  terms
  of the conditional registrations of Gold Crest  Termite,  Gold
  Crest C100, and Chlordane SEC Termite,  and therefore when  these
  products may be sold and distributed.

 0 Will notify Regions  of the effective date of the April  5,  1988
  Notice of Intent to  Suspend Chlordane and Heptachlor Termiticides

 Regions	

 0 Will provide copies  of the Compliance Monitoring Strategy  to
  States.

 8 Will distribute lists of products  to the States.

 0 Will  conduct distrlbutor/dealer/retailer and user  inspections
  in States without Cooperative Enforcement Agreements as part
  of their routine inspectional program.

0 Will  conduct a books and records inspection, in States without
  Cooperative Enforcement Agreements, of non-Velsicol  chlordane/
  heptachlor registrants to determine the first-line distributors
  of those products.

0 Will  issue SSUROs to first-line distributors,  of non-Yelsicol
  chlordane and heptachlor products,  located in their Region.

0 Will  transmit Information on first-line distributors located
  in other Regions to  those Regions.

0 Will  monitor SSUROs  as per the Pesticides  Inspectors' Manual.

0 Will  take enforcement action, including issuing SSUROs, as
  appropri ate.

-------
                              -10-
  Will report to OCM quarterly for one year  on  any  enforcement
  actions taken within their Region, including  State  actions,
  under the cancellation and suspension actions.  This  report
  should include any occurrence of non-con^ormance  with the
  terms of the MOU by Velsicol.  As stipulated  in the  January  29,
  1988 Chi ordane/Heptachlor Compliance Monitoring Strategy,  the
  first report is due April 15, 1988.

  Will notify the States when Velsicol has met  the  terms of
  the conditional registration, and therefore when  Velsicol
  may sell the conditionally registered products.

  Will notify the States of the effective date  of the  chlordane/
  heptachlor suspension.

States	

0 Will conduct inspections by April 29, 1988, of Velsicol's
  establishments that produced chlordane and heptachlor within
  the past 2 years.

0 Will inspect for compliance during routine distributor/dealer/
  retailer and user inspections.
o
o
o
  Will conduct a books and records inspection of non-Velsicol
  chl ordane/heptachlor registrants to determine the first-line
  distributors of those products.

  Upon identification from the books and records inspections,
  States will transmit information on the identity of first-line
  distributors to the Regions.

  Will take enforcement action, Including issuing SSUROs,  as
  appropriate, provided they have the authority.

  Will report to the Regions quarterly for one year on enforcement
  actions taken for violations of the cancellation order.   This
  report should include any occurrence of nonconformance with the
  terms  of the MOU by Velsicol.  As stlpultaed in the January 29,
  1988 Chl ordane/Heptachlor Compliance Monitoring Strategy, the
  first  report 1s due April 7, 1988.

-------
Establishments  Producing  Velsicol's  Chlordane  and
             Heptachlor  Termiticides
                   00876-IL-001
          Velsicol  Chemical  Corporation
              Box  39A  II 1 i noi s  HWY  1
                Ma rshal1 ,  IL 62441
                   00876-TN-001
          Velsicol  Chemical  Corporation
               1199 Warford  Street
                Memphi s ,  TN  38108

-------
                APPENDIX  A

       Retained  ana  Deleted  Uses  of
 V e1s i c ol's  Cnloraane/Heptacnlor  Products
Velsicol classified che following uses  of

ics end-use termiticiae products as

"deleted uses":

  a.   post-construction application of
       material trom within a structure
       frequented by humans ("structure");

  b.   post-construction application of
       material from outside a structure
       to inside or underneath a structure;

  c.   the use of pressure rodding for post-
       construction application of material
       to a baseraenc-type or crawl-space type
       structure;

  d.   pre- or postrconstruction treatment
       of the area underneath crawl-space
       and post and pier type structures;

  e.   treatment of voids and spaces in
       masonry or block walls or areas
       behind veneers;

  f.   applications by non-certified
       applicators;

  g.   soil-injection pressure rodding at
       pressures greater than 25 psi.


     The agreement further classified the

following uses of end-use terroiticide

products as "retained uses":

  a.   application to the outside
       perimeter of any structure  by
       trenching, or  drilling ,through
       sidewalks, patios, gr other
       unenclosed slabs, and applying
       material to the soil without
       pressure (e.g. , How or gravity
       feed);

-------
                  -2-

               APPENDIX  A
                 
  b.   applications by the excavation
       technique to the exterior of any
       structure (i.e. . by removing soil
       next to che  foundation,  placing
       on a tarp, creacing wich
       cerraicicide, and placing back in
       trench after soil dries);

  c.   pre-construction low-pressure
       (maximum "!5  psi) vertical rodding
       (with the application rod equipped
       with a pressure control  device co
       prevenc higher pressures) of che
       perimecer oucside any scruccure;

  d.   post-construction low-pressure
       (maximum 25  psi) vertical rodding
       (with the application rod equipped
       with a pressure control  device to
       prevent higher pressures) outside
       slab and post and pier type
       structures;

  e.   pre-construction coarse spray
       surface treatment (maximum 50 psi)
       and low-pressure (maximum 25 psi)
       vertical rodding (with the
       applicacion rod equipped wich a
       pressure control device  co prevenc
       higher pressures) under  the slab of
       slab type structures.
     The agreement classified one use, the

procecclon of underground cables, as an

"unaffected use".

     In addition  to  this classification  of

che uses of Veisicol's  cermiticide  products.

the agreement  included,  later" alia,  the

rollowing provisions:

0  The retained uses were converted to
   restricted  uses as  provided  for  in
   Sections 3(d)  and 4  of F1FRA;

-------
        A?=END IX A
The registrations or the retained
uses were amended to conditional
registrations, with no sale or
distribution by Velsicol allowed
until certain conditions set forth
in the Conditions of Registration
are met.

No further sale or distribution by
Velsicol of end-use products labeled
for deleted uses was allowed.

Velsicol amended the label of its
manufacturing-use produces to provide
that such products could not be used to
manufacture any end-use product  (other
than Velsicol products) for sale and
distribution  in the United States that
is labeled for use as a subterranean
termiticide.

-------
                           APPENDIX B

             Supplengntal Registrants of Velsicol's
               Chlordane/Heptachlor Termiticides
 (375-03053-000192)

 (376-00053-000430)
(376
(376
(376
 376
 276
 376
(376
(876
(876
(376
(876
(876
-00053-
-00063-
-00063-
-00063-
-00053-
-00063-
-00035-
-00086-
-00086-
-00086-
-00036-
-00086-
 002935}
 005887)
 010370)
 025030)
 034704)
 043227)
 035034)
 000016)
 000192)
 004376)
 005887)
 OC;387)
 876-00036-005887)
 876-
 876-
 376'
 375-
 00085
 00086
 00036
 00036
006723)
010370)
012000)
012000)
(375-00036-034704)
(376-00100-000192 )
(376-00104-000430)
(376-00104-001812)

(376-J0104-004876)
(876-00104-006723)
(376-00104-025030)
(376-00104-042761)
(376-00233-001927)
(876-00233-006754)
Drexol Chlordane 721 Termite Spray for
Professional Termite Use
Durham's Chlordane Emulsifiaole Consentrate
Insecticide for Use Only By Professionals
Red-Top Chlordane 8 Spray
Black Leaf 72X Chlordane Emulsifiable Concentrate
Ford's Chlordane SEC
Red Panther Chlordane SEC
Pro-Chlordane 8-E
Chloro-800 Emulsifiable Consentrate Insecticide
Diversey 2.5 H
Dragon 451 Chlordane Spray
Dexol Chlordane 45% Termite Spray (Prof,
AG Chlordane 4-EC Termite Control
Black Leaf 45X Chlordane Termite Killer
Black Leaf 45% Chlordane
Around Buildings
Black Leaf 451 Chlordane
Insect i cide
Red Wing Chlordane 4 EC
Ford ' s Chiordane 4 EC
K Mart 45* Chlordane Termite
K Mart 45t Chlordane Termite
Build1! ngs
Pro-Chlordane 4-E
Dexol Chlordane Termite Spray
Durham's Chlordane SEC Emulsifiable Concentrate
Pee Gee 8 1bs. per gallon Chlordane Emulsifiaole
Concentrate
Chlordane-8 Termite Control
Red Wi ng Chiordane SEC
Red Panther Chlordane
Red Panther Chlordane SEC
Termi nix C-H
Orkil 2X
               /Termite Use
       1
        Killer
Termite Killer For Use

Emulsifiable Consentrate
    Killer
    Killer
for Use Around

-------
Pio* I:.
01/06/18
         ST;?  SALES iss:i: >.s :v
                                       of  Products Containing
                                      rdane and Heptachlor
COSPA5!
                                .*.
CEiSICAL
ss iss
WVA! CEEKICAL CCEP.           548:  223
4100 iAST  HASEINGTCI BLVD
LOS AS-'-LES    CA 90023

AKVAC C-iHICiL CCS?.           546.  226
415C EAST  HASEU'/OJi SIV:
LOS W;:LS    CA 50223

WT;AC CSIIUCAL CORP.           5481  H5
4 ICC EAST  WSEIHrOS BT.V?
LOS ASGiLES    CA 9CJ23

AHVAC c?j:c!.: :?s?.           5461  so
4K: Ef.SI  ASi:!S;*jli rlVD
LOS MGELES    CA 90C2J
A3 C-'SICM  C3E?.
1514 ELEViSTK  "
POETSC.G3TE    OE 45662
                                         CHLCSDASE
                                         CELORDASE
                                         CELOHDASE
                              7122  121
AS CE-KICAL COST.              7122  !
!5:4 ElIVESTr ST
PrH'S^;"::     OE  45662

A- CHZ!::A: cos?.              ?;:.'  34
1514 L1EVESTE ST
FCETS0;*S     QE  456:2
                                                                                     Ol/Ob/BB    /   /    OS     CA
                                                                                      01/06/88    /  /    09     CA
                                                                                      01/06/88    /  /   OS     CA
                                                                                      01/05/88    /  /   09     CA
 01/06/88    /  /   05      OE
                                                                                      01/06/58    /  / '  0!     OE
                                                                                      Ol/Os/58     '  /   05     OE
B & G CCHFABK
10539 SAl-BASS  DH  BOX 20372
DALLAS         ?X 75220
                              86:2  66
                                          CHW3DAS:
BLAC? LEA? PSODrCTS  CO.        5i8?  127
667 D STATE ST                            CELOF.DASE
ELGI5          11 6012;

BLACK LEAP ?80D5CTS  CO.        58!?  67
667 I STATE ST                            C8LORMJE
8LGIN          II 60120

BORBIB CEEf.iCAL CO.,  IK.      4     274
2 mi AVE.                               C--.Q5DASE
IOESV.LLE      HK 13495

BOFDI! CH-ICAL CD.,  ISC.      4     21?
I mi AVE.                               CHLC'Sl.'.SE
JOP.'VILLE      *1 13495
EOS:!  CSEf.ICAL CO.,  INC.
i M.'SZ AVE.
KO-ltVlLLE      SY 1*495
 01/06/88    /  /    16     TX
                                                                                      01/06/88     /   /   cs
                                                                                      01/Ob.'8B
                                                                                      01/06/88    /   /    C2     SY
                                                                                      11/06-'BE    /   '    ..'     S:
                                                                                                         (.1
                                          CELORIANE

-------
                           APPENDIX B

             Supplemental  Registrants of Velsicol's
               Chiordane/Heptachlor Termi tic ides
(876-00063-000192)

(876-00063-000430)
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
00063
00063
00063
00063
00063
00063
00085
00086
00086
00086
00086
00086
002935)
005887)
010370)
025030)
034704)
-043227)
035034)
000016)
000192)
-004876
005887)
-005887)
(876-00086-005887)
(876-
(876-
(876-
(876-

(876-
(876-
(876-
(876-

(876-
(876-
(876-
(876-
(876-
(875-
00086
on o.s 6
00086
00086

00086.
00100
00104.
00104

00104
00104.
00104.
00104.
00233-
00233.
-006723)
-010370)
-012000)
012000)

-034704)
-000192)
000430)
001812)

-004876)
006723)
025030)
042761)
001927)
006754)
Orexol Chlordane 72% Termite Spray for
Professional Termite Use
Durham's Chlordane Emulsifiable Consentrate
Insecticide for Use Only By Professionals
Red-Top Chlordane 8 Spray
Black Leaf 72% Chlordane Emulsifiable Concentrate
Ford's Chlordane SEC
Red Panther Chlordane SEC
Pro-Chlordane 8-E
Chloro-800 Emulsifiable Consentrate  Insecticide
Diversey 2.5 H
Dragon 45% Chlordane Spray
Dexol Chlordane 45% Termite Spray  (Prof./Termite  Use)
AG Chlordane 4-EC Termite Control
Black Leaf 45% Chlordane Termite Killer
Black Leaf 45% Chlordane Termite Killer  For  Use
Around Bui 1di ngs
Black Leaf 45% Chlordane Emulsifiable Consentrate
Insecti ci de
Red Wing Chlordane 4 EC
Ford ' s Chiordane 4 EC
K Mart 45% Chlordane Termite Killer
K Mart 45% Chlordane Termite Killer
B u i 1 d i ngs
Pro-Chlordane 4-E
Dexol Chlordane Termite Spray
Durham's Chlordane 8E3 Emulsifiable
Pee Gee 8 1bs. per gallon Chlordane
Concentrate
Chlordane-8 Termite Control
Red Wing Chlordane SEC
Red Panther Chlordane
Red Panther Chlordane SEC
Terminix C-H
Orkil 2X
for Use Around
Concent rat e
Emu!s i fi able

-------
                          APPENDIX C
                     CHLORDANE CANCELLATIONS

COHPM7Y             EPA REGISTRATION NO.          EFFECTIVE  I

Bonide Chemical          4-96                     3/17/83
                         4-218                    3/17/88
                         4-274                    3/17/88
                         4-275                    3/17/88
                         4-287                    3/17/88

Dragon Chemical
Corporation              16-96                    4/27/87
                         16-116                   4/27/87
                         16-122                   4/27/87
                         16-124                   4/27/87

Rigo Company
Incorporated             70-119                   4/27/87

Thompson-Hayward
Chemical Company         148-27                   6/01/87

-------
      Industries
Tobacco States Chemical
Company
Chevron Chemical
Company
FI-'C Corporation
                         191-42
                         192-43
                         192-132
                         192-133
                         226-177
                         226-184
                         239-478
                         239-1232

                         279-383
                         279-538
C.J. Martin Company      299-171

Res id-ex Corporation    . 373-26
                                                  3/20.- 83
                                                  3 / 3 0 / 8 S
                                                  3/30/88
4/27/87
4/27/S7
3/25/87
3/25/87

3/07/87
11/01/86

3/25/87

3/25/87
Imperial Incorporated
Boyle-Hidvay Inc.

Rockland Chemical
Company Incorporated

Haviiand Agricultural
Chemical Compajiy
Federal Chemical
Company Incorporated
Prentiss Drug &
Chemical Company

Perk Products '&
Chemical Company

Southland Pearson &
Company
                         407-269
                         407-400

                         475-192
                         572-65
                         595-129
                         595-321
                         654-12
                         654-19
                         654-67
                         654-110
                         655-516


                         690-53
                         728-45
                         728-47
3/25/87
3/25/87

3/25/87


3/25/S7
3/25/87
3/25/87
6/01/87
7/01/87
7/01/87
6/01/87
3/25/87


7/01/87
3/24/88
3/24/88

-------
MFA Oil Corr.par.y
Security Lav.Ti and
Garden Products Co.
Faesy i Besthoff
Incorporated

Cl~.as. H. Lilly Co.

Green Light Company


Velsicol Cher.ical Co
Miller Che-ical &
Fertilizer Corporation
Cre-O-Tox Chemical
Products Company
Seacoast Labortories
Incorporated


Cotton States Chemical
Company


Land 0'Lakes
Universal Cooperatives
Incorporated
746-53
746-76
746-119
769-90
769-511
779-82
802-71
3 15
315
3
3/25/87
3/25/87
6/02/87


9. il/7
869-14
869-188
876-63
876-86
876-100
876-104
876-233
876-281
876-303
876-304
876-305
876-306
876-308
876-309
876-310
904-135
904-223
1066-26
1066-28
1066-29
1159-102
1159-178
1339-74
1339-87
1381-51
1381-83
3/25/87
3/25/87
11/04/87
3/25/37
3/25/87
11/04/87
11/04/87
9/28/87
9/28/87
9/28/87
9/28/87
9/28/87
9/28/87
4/28/87
4/27/87
3/25/87
3/25/87
7/01/87
7/01/87
3/19/88
7/01/87
7/01/87
8/20/87
8/20/87
3/25/87
3/25/87
1386-26
 3/25/87

-------
                        7"
u<-.-: tiebach Chemical
Co: porat i on
PCX, Incorporated
Griffin Corporation
1336-324
1386-353

1421-23
1598-145
1598-244

1812-242
1812-243
     d ,. 2 0 . 8 -
     8/20,67

     3/21. SS
     4/27/37
     4/27/87

     7/01,-'8 7
     7/01 /87
Triangle Chemical
Cor.par.y
1S42-41
1842-42
                                                  5/14/87
Terir.inix Division
cf Cook Industries
Incorporated
ELCO I'!anuiacturir.c Co

Farmland  Industries
Incorporated
v;.R. Grace  & Company

PEI-Gordon
Corporation
Hopkins Agricultural
Chemical

Colonial Products
Incorporated
LaRocne Industries
Earl May Seed  & Nursery
L.P.

Stephenson Chemical
Company Incorporate
1927-5
1927-20
1927-21
1927-49

1941-66
1990-178
1990-179

2124-742
2217-34
2217-98
2393-350
3314-73
3314-74
3442-747
3442-816
3442-846
3442-847

3772-8
4887-19
4887-48
4887-183
     2/19/87
     2/19/87
     2/19/87
     2/19/87

     7/01/87
     3/25/87
     3/25/87

     3/28/88
     5/01/87
     5/01/87
     3/25/87
7/01/87
7/01/87
3/25/87
3/25/87
3/25/87
3/25/87

3/25/87
3/22/88
3/22/88
3/22/88

-------
:-=:!wood Chemical,
Incorporated
Coastal Chemical
Corporation

Chacon Chemical
Corporation

GRO Chemical
Company

Helena Chep.ical
Company
Octagon Process
Incorported

     rn Corporation
4931-5
Forshav Chemical
Company
Voluntary Puchasing
Group, Inc.
B & G Company

Sunniland Corporation

Nationwide Chemical
Products, Inc.


Ross-Daniels, Inc.

Cornbelt Chemical
Company
5549-41
5719-24
5778-33
5905-97
5905-102
5830-15

7122-3
7122-34
7122-121
7234-5
7234-6
7234-10
7234-100
7234-101
7234-20
7401-78
7401-348

8612-86

9404-6
9591-6
9591-7

9649-2
10107-7
10107-8
6/29, 8'
6/29/3'
3/17/88
7/01/87
6/11/87
3/25/87
3/25/87
7/01/87

3/17/88
3/17/38
3/17/88
3/17/83
3/17/88
3/18/88
3/17/E8
3/17/88
3/18/88
 6/18/87
 6/18/87

 3/21/88

 3/23/88
 10/01/87
 10/01/87

 6/12/87
 3/21/88
 3/21/8E

-------
:-;rd's Cae-iral  i,
Service  Incorporated
Hacienda  Enterprises

?u.~a Chemical  Company

Lrexel Chemical  Ccrcanv
Flatte Chemical
Cc-pany

Falls Chemical
Kaw Valley,  Inc.


Wilson Laboratories


Caterer. I-:. Bairc

r-'icro-Flo  Company
Garden Care  by
Farmingdale,  Ltd.
10370-40
1 0 3 T 0 - 11 6
10370-144
10370-145

11037-7

11611-4

19713-214
19713-215


34704-1
40831-5
40631-24

44215-7
44215-20

50383-20
50383-29

50415-27

51036-30
51036-31
53127-1
53127-10
                        3,28-83
                        3.- 2 b 35
                        3/23/83
                        3/ 23,53

                        4/27/S7

                        7/17/8 7

                        3/24.. SS
                        3/24/38


                        4/27/87
                         3/24/88
                         3/24/88

                         9/08/87
                         12/12/87

                         3/24/88
                         3/24/88

                         7/01/87

                         11/13/87
                         11/13/87
                         3/22/88
                         3/22/88
                     HEPTACHLOR
COMPANY

Thompson-Hayward
Chemical Co.

Velsicol Cnemical
Corporation
EPA REGISTRATION NO.
148-964
876-101
876-85
876-233
876-308
876-309
876-310
                    EFFECTIVE DATE
                         6/01/87
                         4/27/87
                         9/28/87
                         11/04/87
                         9/28/87
                         4/27/87
                         4/27/87

-------
                        -7-
Cre-O-Tox Chemical
Products Company
Griffin Corporation

Triangle Che-deal Co.

Terr.inix Division of
Cook Industries, Inc.

Stephenson Chemical
Company Incorporate


Rocv:ood Chemical, Inc.

Red V,Ting Chenicai
Icrpany
                       
;-.r;~heir; Corporaticr.

Forsh.w Chemical Company



Chem-Nut, Inc.

Farmco Industries
Incorporated

Micro-Flo Company
1066-28
1066-29
1066-30

1812-77

1342-183


1927-50
4887-59
4387-85

4981-17
6723-8

7122-6

7234-27
7234-31
7234-89

37686-27


46778-1

51036-50
7/01/87
3/19/88
7/01/87

7/01/87

5/14/87


4/21/87
3/22/88
3/22/88

 7/08/63
6/07/84

3/17/8 8

3/13/83
3/18/88
3/18/88

5/08/87


5/12/87

4/27/87

-------
     APPENDIX  D
   CHLOR n7Ji?>
                                       i .? ION 5
                         EPA_P F.G.I_STRAT
Var. Wdt.ers  &  Rogers,  Inc.
Cl'.apr.an Cheir.ical
Con.pany

Vaccinol Chemical  Company
Incorported

A-'-r.T^C Cher.ical  Corporation
          550-106
          550-107
          1022-502
          1353-4

          5481-223
          5461-226
          5461-50
          5481-315
EFFECTTJVE DATE

7/18/87
7/18/87
 7/15/87
7/15/87

7/17/87
7/17/87
7/17/87
7/17/87
Carolina Cher.ical
Corporar ion

EIa:>: Leaf Products
Cor.pany
S-ut-hern Kill  Creek
Products
Dettlebach  Pesticide
Corporation
Mystic Chemical Products
          5797-88
          5857-67
          5587-127
U.S. Marketing  Distributors  6409-13
          6720-2
          6720-71
          6720-133
          6720-176
          6720-260
          6720-361
          6720-363
          6754-9
          6754-11
          5754-40
          6754-64

          36272-3
 7/15/37
7/16/87
7/16/67

10/21/87
7/15/87
7/15/87
7/15/67
7/15/87
7/15/87
7/15/87
7/15/87
7/15/37
7/15/87
7/15/87
7/15/87

7/15/87
COMPANY

Southern  Mill Creek
Products  Cor.pany
 Pett ] er-acri Pesticide
 Corporal ion
   REPTACHLOR SUSPENSIONS

EPA REGISTRATION  NO.
     6720-279
     6754-5
     6754-40
     6754-54
     6754-64
 EFFECTIVE DATE
 7/12/87
 7/15/37
 7/15/67
 7/15/87
 7/15/87

-------
P9 *c-         ]                     of  Products  Containing
01/06/88         I                    rdanc and Heptachlor
        STOP SALK ISS:ZD AS :i   .    : ci s:t:o
                           ^  isi.-..  :EI HFIA
COTPAIT
f?A ?.:'.-.I   PSOXCT i CEL1ICAL
ss
AKVAC CHEMICAL CORP.
4100 UST HASIIIGTOI BLVD
LOS ANGELES    Ci 9002]

AC.VAC CEMICAL C08P.
4100 EAST VASEIKTOS SIVJ
LOS ASGELES    CA 9CC23

AKVAC CB1M1CAL COIP.
4100 EAST WSIU7TOI VM
LOS AUGELES    CA 90023

AHVAC C5EHICAL COEP.
4100 EAST MASHl)i::oii !ITO
LOS AJGEU5    CA 9002)

A! CS!C!C COB?.
1514 ELSVEITE ST
              01 45f62
 Al CE!*.ICAL COS?.
 1514 ElEVHTH ST
 POBTSXOOTH    01 4S662

 A3 CSZR1CAL COSP.
 1514 ELJVEIT! S7
 rCBTSROOTI    0! 5f62

 BIGCOVAI!
 10539 UlWl N BOI 20372
 MllM    --  H 75220-

 BUC! UIP PtDMCK CO.
 667 I STATE ST
 ELCI1         IL 10120

 ma uu PIOOOCTS co.
 667 1 nm ST
 ncn     i
 BOWII cmicu co., lie.
 2 NU m.
 ntimu     n IM^

 KPDIE CE2MCAL CO., 1 1C.
 2 Mil ATE.
 TOtmiLE     II 13495

 BWOIB C1BICAL CO.. C.
 2 M-'li AV!.
 TOftlVILLE     IT 1)4*5
54bi  223
5461  226
5481  J15
5481  50
7122  121
 7122  3
 7122  34-
           CHLOBDAHE
           CELORDASE
           CILOBDAI!
           CSLR?A!S
           CBLCRLASH
           CllOSDAJE
 0(12  If
 5887  127
 5817  67
 4    274
 4    275
           CIUlDAi!
           C1IABDAIE
           CBLOBDAJE
            CHIOSDU!
            CHIOS!***
C1/06/6B    /   /   OS     CA
01/06/88    /  /    09
01/06/88   /  /   09     CA
 01/06/88   /  /   09     CA
 01/C6/U   /  /   05     OE
 81/06/88    /  / ' 05     OE
 01/06/8(    /  /   05    05
 01/K/N    /  /   06    T!
 61/06/n    /   /   05     ::
 01/06/88    /  /   OS     I
 01/06/88    /  /   02
 01/06/88    /  '   02     !i
                                                     01/06/88    /   /   vi    .>

-------
Pio* lo.     2
  
         STOP SALES ISSUED AS TB! RESULT OS  SECTIOI  KcH2)t3>
                        F!is::'55 ISSUE? r-Mi?  F:F?.

                               m sE'.-.i  ?F.::UC' i :?:.::AL
                                                                                        ?? :SS?EJ LIPTDATS  ::;
mill CSMICAL CO.. IK.      4     287
I fr.-RL MS.                                CEWSDASE
                                                                                                           02
 or.iE CH.:CAI co.. :s:.      4
BON::- :=.WICA: co., me.      4
:A?.OIISA CEEHICAL cos?.        5"?i  86
               SC 2?S^
                                                                                                           E2
                                           CSLOSDMe
                                           CSMEDASE
                                           C-13RD.W:
                                                                                        Ot, JO/85    /  /   !!4     DO
                                                                                                    /  .'   64     TS
COAST'.'. CH!*I'?.l.l CO?.?.
.'.'. >J 5t
3r--SV::i:     SC i?i)4

":-..' BELT THE SI ?A1 CO.
?.:. -:x <:'.
SCCJOX         S! *9GC1
CCi!< ?Eir CESRICIL CO.
':.:. g.JS- 410
?.:::-0!!         SE 69fl!:i
                               5549  41
                                1:107 /
                                1010? 8
                                           C:LOHDiE
CBE-O-TOI CEZSICAI, PSOD. CO.   1066  29
BOX 12598
KSHP8IS        TS M112

C52-0-TOI CIBICAi PSOD. CO.   10t6  29
BOI 12598
HSPHIS        T 38112

D!TTE1 SACS PESTICIDE CORP.    6754  11
P.O. BOI 9986
AT:I:A        GA 30119

D:TT:L ?ACE PESTICIDE COSP.    6714  40
r.:. BOX 99-:r
iTliSTA        GA 3031?
DETTsi AC? ?EST:CIDL CORP.     67?  40
P.O. ri'X 998*
AL7ASTA        GA  3';319
                                           CEL43DANE
                                           CELOEDAHE
                                           5EPT4CEI05
                                           CELOKAS!
                                           CHLORDAHE
                                           SEPTACELOF.
Oi/Ct/SS    /   /    04     SC
Cl/56/88     /   /    07
01/St/!8    /   /    07     SS
                                                                                         01/06/88     /   /   04     T5
                                                                                         01/C6/88     /   /    C4     T
                                                                                         01/06/58    /   /    C4     GA
                                                                                         ')..'06/88    /   /    Q4      :-A
                                                                                                            '4

-------
Pi lo.      3
         STOP SALES  ISS--ED AS TEE 1ESILT OS SSCTIOI
                    ?:SPEISI01IS ISS?: MDES FIP8A
:e*.?AY
                              ErA !K.I   PSOMCT i CEERICAI,
ss issvED LI?TDA:E  RE^
DETTE', 5*C1:  PESTICIDE  COB?
?.0. -OX 99i?
?TTTE'  EA.Cii ?E5?IIIDi  CORP.
i'.O. sOS ?9e
i::js:i        '-A  K-JI*
rETT:" B.'.CE PESTICIDE COSP.
?.c. BCX wet
ATLASTA        GA 30319

:ir.-.; nr- PESTICIDE ccap.
:... '.} -
A'.TASTA         Jv.!19

%? sice :pe-("*,r "?3
..>.. ..!. .^^to . %... .
?.C. :C!f *
AT1ASTA        3A J331J

DETTELEA.CF. CS2SICA1S COSP.
,'*7t APP1: VALLEK SE.
ATLANTA        GA JCii9
                              6754  5
                              '.7!4  54
DETTSL SACS PESTICIDE  CORP.    b754  54

ALTASTA        GA  W19
                              6754  64
                               t'54  64
:45i a. 22bT:: ST.
T:?.?.ASCS       CA  9t5ti

MIC! I^STEIES
i45i . 223TH ST.
TCiiUCE       CA  90501

:-KL IIDOSTSIES
145v K. 22m R.
T3RRAHCE       CA  905G1

PEXCl ISDDSTRIES
1450 N. 228TS ST.
TCP.JASCE       CA  9C501

DRSIEL CaiSICAL CORPASY
i4J7 PJSSS1LMIA ST. ?J! H
*.i*?HIS        TS  J8;v5
D?.!XL CHSHICIL COBIW
i4S' JESSSYIASIA ST. 50! 9}0b
!.*.? HIS        TS i^li'6
                               1*^1   2J
                               :?2   132
                               192   133
                               192   42
                               192   43
                               ;?7i3 214
                               19713 215
                                          KPTACSLOH
                                          CELC-BDASE
                                          EEPTACB108
                                          CtieMLM
                                          EZPTACHLOS
                                          CELCiDASE
                                          CEWS3AS!
                                           CHLCSDASE
                                           CHMEDA5E
                                           CHW5W.SB
                                           CHLOBDME
                                           CHLOBDASE
                                           CHIORDASE
            .'   /   (4
01/06/86    /  /   '4
                                                                                        fll/Ot/S8
01/06/88    /  /   G4     GA
01/06/88    /  /   :<     '.-A
                                                                                        01/06/83    /   '   04
                                                                                        01/05/88     ;   /   ro     CA
                                                                                        U1/C6/B8
             /   /
                                                                                                                  CA

-------
 C* !K     4
         STOP SAHS  us:*: AS ?  RESULT rs SE:TIOI
                      si'SrEisiois us!-'-  *:-?  ?:?.
                                !?A .-.   ?-OJ!;C? 4 CsS'ICAL
                                                                                          5    SVED
FALLS ."ICALS. IRC.
i-.C. SOJ *S45
.:?.EAT -A1L5    *T' '4v
                                            CEL02M.SZ
-;.::? -rsEsiCsLs.  :sc.
i.v. -;T ^:4^
:?.E?.7 -ALL?    *
::?.:?  :::-:cfeL   SERVICE IK.   iuiic ::
J.T ?I.>A.:-SI 5LVL'.
;A5A:iSS       TX  "502

?:-?.:s c-isicuL   SZP.VICE INC.   103?: .44
'OPTS  "ii'ICAL i SE-VICE  I!EC.   .C:T  .4;
*Tj? FA5AJESA Sl'vT.                         'J-LO-rASE
PAS.O-SA       TI  775C2

"?.:?  rHiSTCAL i 5E-.VKE  ISC.   10?/? 40
."jy PASADENA SVv'L.                         T-'.vP.DASE


:'.-.j-Aii :H-y.CIAl CO.            :<43  ^*
Jr: STATE STr.:ET                            EE-TACEL::


r'RSEASi CHEftCiAL CO.            7243  3:
E". STATE STREET                            E:?"J.CELC-
CHARLOTTE      5C  28208

FCRSEA* CHMCIAL- CO.            T24J  *
t-5i STATE STREET                            5EPTAC5LOH
CHARLOTTE      5C  282?!<

FORSEAK CHffllCAL CO.            7234  ISO
t5fl STATE S11MT                            CHLORjASE
CHARMTTE      1C  28208

F'TiSEAK CHttlCAL CO.            7234  101
?:i STATS STREET                            CELOBDASi
wiAr._-...;      SC  2KJG8

FC:.S-AW C-HJ'.ICAL CO.            "224  5
?:. ?"ATE STP.EE"                            CELOP.DASE
CHA.'ICTTE      SC  2S21.'?


"E. STATE STREET                            CHLORDAN!
':!?.?!:TTE      HC  iOJL'S
                                                                                          ::/Ob/et    /   /    56
                                                                                          1/66/88    /  /   06     TI
                                                                                          Oi/fl{;/b    /  /   C4     .-.'c
                                                                                          1)1/06/58    /  /   C4
                                                                                           01/06/88     /   .'    C4     SC
                                                                                           01/06/38
                                                                                           01/06/88     /   /    04      NT
                                                                                                       .'   /    4      S-T
                                                                                                       '   .'

-------
STC? 5AL2S IJSVi: AS Trit  SiSvLT  OS  5ZC?IO!i j.r;
            srsr'ssioss :??'.!  .?:?  -ir-A
                       .-.  ?;.!    ;;>:? * c-2r.::Ai

* t-'  -:' I   ^  " '  i  S  **"-'











':.';. ?.! l(r-r::4  S  *:!                  :?7A.~LC?
Tr.'lrA           FL !':-ru

5'"'.'T'-E.:S "ILL  CEEi.' ?8C'?:. CO.  i'lO  ^80
?.C. BOX lc  5:14  S  stTii                  C?.jjEDAS


?"ii?.!i BILL  C5i;S P5.CD. CO.  *''t\>  ti'.
P,C. 301 1096  5514  li  5?E                  CEIO-DME
TAA           FL 3W01

SC'JTHEHS SILL  ?.:  PS?!). CO.  6720  J63
I-.;. JCX ICVt  ??.4  S  5t:::                  CELOR3AS
>".?*.           Fl 'jbCl
                                                                                  'l.-CS/t
                                                                                  Cl'Ct'B?
                                                                                                      C4
?""??$
                  CO.
                             45

-------
         ST.; 5A.'.-? iss'-i  ?  *;  ?  '.'   ' fi.i;.
                     SCJriSf". >.c l?f :.  >.:.- ''.:':
ST-'rH'?"?:!* Cr.1*. CC..  IS1?.      48:"   '.-
:-Y ;-                                   'Hlir-j
c::::-:- ???   :A  :;;"

r:?::1*?'.!! C5:.".. CC'.,  ISC.      4::"   :
BOX 5'ic:                                   C:-:LI?.:.
COLLEG- PftR?   GA  JOJi1

?T-?HiS=:S I":!1. TO..  ISC.      4S:'1   :*
!0i' v'.:*                                   HE??.V!
CC::E-:E -A?r   ;?.  .  :;"

?TI?:ESMS CHi*. "I..  IM.      4::"   ::
?I'NSI1A!I'  COr.PIrATIIR          -4.4
     ;.- AV;:,.:   ?.I.E?!? .""
VACCIS:L  CHI:AL co..  INC.    i-s:  4
1:2?- SI":  HII-:-:iAS--
VAN WTZ8S  i  P.OGEP.S            550
225t JDHCTMS  AVES'JE
SA* JOSE        CA 95:51

VAN MATERS  &  BOGEP.S            550
2256 JMCTIOJ  AVESI!
SAS JOS!        CA 95131

M ?. C-SAC! i CORPARY            2124
P.0.30! 27? 10? H RAM ST.
HES?s:S         TS 3B10.'
 HI".SOS  1A-S.  INC.
 ;.:.  MJ  ;!:"
 5?rISC-:A'.E     "T
 I15I!i  1AE5,  IS?.              5G;;:-

-------
                  Federal RexiMor /  Vol.  5U. No. 212  / Tuosilny.  November 3. ll8"  / Notice*
                                                                       42
h',iiln-:.iriiTS litnlititiK id 4111 V Slrtvl
S\\ . V. '.ifchmstnn. L)C.
  The purpose of the mrvimg is In
n \ icw (ho first Jraft of the Risk
leiJi.i;tion Croup's stralcKN on
i-nv ii<::in:c:i::il risk reduction
  Tl. meeting is opt:n to the public. Any
mcir.ber of thf public wishing to attend.
n:jke brief or4il comments, or submit
written comments to the Croup should
notify Mrs  Kathleen Conv.-ay. Executive
Secretary, or Mrs. Dorothy Clark. Staff
Secretary. (A101-F) Sciencn Advisory
Board, by the close- of business on
Friday. November 20.1987. The
telephone number is {202} 382-2552
Terry F. Yosie.
Director. Science Advisory Board.
  D.ile  October 23. 19,".
|FR Doc. 87-25383 Filod 11-2-67: 8 45 nm)
BILLING CODE eSGO-SO-U
tFPL-3266-1)

Science Advisory Board Research
Strategy Subcommittee Sources,
Transport and Fate Group; Open
Meeting

  Under Pub. L S2-463. notice is hereby
Riven that the Sources. Transport and
Fate Subgroup of the Science Advisory
Board's Rescarrh Strategies
Subcommittee will met I from 9:00 a.m.
to 4:00 p.m. on December 8th at the
Hyatt Regency Hotel. International
Parkway (inside the Dallas Fort Worth
Airport), in the Conference Room. The
purpose of the Research Strategies
Subcommittee is to advise the
Administrator of the Environmental
Protection Agency on the dex-elopment
of research strategies needed to enhance
the Agency's ability to acquire scientific
and technical information to support
regulatory decision making, and to
identify emerging environmental issues.
The Sources. Transport and Fate
Subgroup will evaluate environmental
contaminants from both a media-
specific and a multi-media basis.
  The meeting M open to the public. Any
member of the public wishing to attend
or submit written comment* should
notify Dr. Terry F. Yosie. Director.
Science Advisory Board, at 202-382-
4126 or Joanna  Foellmer by December 4.
1907.
  Dale: October 23.1987.
Terry F.Yoiie.
Director. Science Advisory Board.
(FR Doc. 87-25391 Filed 11-2-67; 8:45 m|
      coot MW-SO-N
IOPP-60011; FRL-3286-a I

Chlordane and Heptachlor
Termiticides; Cancellation Order
AGENCY: Environmental Protection
Aponcy (EPA).
ACTION; Order.

SUMMARY: Or. October i. 19B7. EPA
issued an Order accepting the voluntary
cancellation of certain chlorcane and
hcptachlor tcrmiticide registrations held
by Velsicol Chemical Corporation, and
limiting the use of existing stocks of
Velsicol's chlordane and heptachlor
termiticide products outside the
company's control on August 11.1987.
Under the terms of the Order, such
stocks may be sold, distributed or used
according to their current labels until
November 30.1987. Frcm December 1.
19C7 until April 15.19ft6. such stocks
may onl> be sold, distributed or used in
accordance with the Directions for  Use
accompanying the Order. No sale.
distribution or use of such stocks will be
permitted after April IS. 1988.
FOR FURTHER INFORMATION CONTACT:
By mail: George LaRocr.a. Registration
  Division (TS-767C). Office of Pesticide
  Programs. Environmental Protection
  Agency. 401 M Street SW..
  Washington. DC 20480.
Office location and telephone number:
  Rm. 204. Crystal Mail Building *2.
  1921 Jefferson Davis Highway.
  Arlington. VA. (703) 557-2400.
SUPPLEMENTARY INFORMATION: On
August 11.1987. EPA and ' 'elsicol
Chemical Corporation (Velsicol) entered
into an agreement affecting Velsicol's
registrations of chlordane and
heptachlor termiticide products [except
for a registration involving underground
cable treatments). Under the terms of
the agreement, certain uses of Velsicol's
tcrmiticide products were deleted from
the label and the remainder of the
registrations were converted into
conditional registrations. Under the
terms of the conditional registrations, no
further tale or distribution by Velsicol of
its affected chlordane and heptachior
termiticide products was allowed unless
and until Velsicol satisfied air
monitoring requirements specified  in the
conditional registrations. The August
llth agreement did not affect existing
stocks of Velsicol's termiticide products
outside of Veisicol's control on or faatore
 that date (which EPA estimated at  the
 time to be a volume equal to
 approximately 2 months average use. or
 about 110.000 gallons).
  Portions of the August llth agreement
 were challenged by a number of
 environmental groups \o a fedend court
 action.
  Tl"p (.I'irt in !iiH< .i. nun r\|ir >> .!
i:iiiii.-Tn iti.it Ki'.\ ".'.^nl n.iv
!nt|i-rc
-------
42141,
Fod.Tjl  Register  /  Vol. 52. No.  2\2 ; Ttifsd.iy.  \n
                                \ci:i!.r  3. inn? /
us.- 'i T.:1.. :iii; pr:.tU:irii(in ;ir>;>lic;jtlon of
m  ;. -; i. f^nn. vvi'h:r. .1 strm.lure
fr- .  ; :i!i-;j !,\ humans (' structure"):
   I-  l':i\: c;jr.s:r;:ction ap^iica(:on of
rr.  ;  r:j; frorr. outbid1.1 n structure IO
ir.s.Jc n; underneath a structure:
   c The use of pressure roddine for
post-construction application of mjterial
tn  ;i boseri.^nt-type or crax-. l-space type
stn.'Cturr:
  ri. Pre- or post-ccnstrvictior. treatment
of  :hc area underneath crawi-space and
post  und pier type structures:
  e. Tren'rr.cnt of voids and spaces in
masonry cr block wal:s or areas behind
venders:
  f Applications by non-certified
applicators;
  ;> Soil-injection pressure roddir.g at
prrssuros greater than 25 psi.
  Yhr agreement further classified the
following USPS of end-use termiticide
products as "retained uses":
  a. Application to the outside perimeter
of any structure by trenching, or drilling
through sidewalks, patios, or other
ur'T.f!o>
VelsiLul of cnd-u:e products l.i! h-d fui
deleted usi:s w.is jiiowrd
   Velsicol amended the label uf its
manufacturing-use products to provide
that such products could not be used to
manufacture any end-use product (ether
than Velsicol products) for sale and
distribution in the United States that is
labeled for use as a sublerrancnn
termiticide.
  The agreement became effective
immediately on August 11.7987. In
return for the conditions accepted by
Velsicol. EPA agreed, inter alia, that it
would  take no action against existing
stocks  of Velsicol's products then in the
hands of applicators and distributors.
EPA estimated that a volume equal to
approximately two-months average use
of chlordane  and hep'.achlor termiticides
(or approximately  110.COO gallons) was
in the hands of applicators and
distributors as ct August llth.
  Portions of the agreement between
Velsicol and  EPA have been challenged
in a federal court action brought by a
number of environmental groups
[NCAMP v. EPA. Civil Action No. 87-
1089-LFO. D.D.C.) The court in that
action  has expressed concerns '.hat EPA
may have substantially  underestimated
the amount of existing stocks as of
August llth or that some individuals
may have large stockpiles of chlordane
products. While EPA continues Io
believe that its earlier estimate of
existing stock was an accurate one. Er \
contacted Velsicol (as well as the
plaintiffs in the federal litigation) to
discuss possible amendments to the
August 11 agreement in order to resolve
the court's corrern. Velsicol agreed to
amend the agreement, and on October 1.
1987. Velsicol and EAP ratified a
Supplement to the Memorandum of
Understanding (a copy of which is
attached hereto}.
   Under the  terms of this Supplement.
Velaicol's chloradane termiticide
registrations have been split into
product registrations containing the
deleted uses and product registrations
containing the retained uses. Velsicol
and EPA have agreed to the voluntary
cancellation of certain product
registrations, including  those containing
the deleted uses (but not those
containing the retained uses),  and  have
further agreed to the placement of a
two-tiered cap on the use of existing
stocks of Velsicol's products outside of
its control before  August 11. These
existing stocks may be  sold, distributed.
and used in any manner consistent wild
their labeling until November 30.1987.
                                                              l'rn:n Dcfnil'.-r 1. TOP" unlil April 15.
                                                              1'iiill. Ihcsf s>tiicks r.Niy lit- so!;l.
                                                              distributed, ar.il i...i-d only in lire  J.imr
                                                              .\ ilh ihc n>nH:!-."r.N rf use  prr-sr:.  --J in
                                                              Appendix A o! this Or-.irr. No use will
                                                              be prrmittcd after April 15. 19U8.
                                                                FI'A believes the ti;rms of this
                                                              Supplement will allow fur an orderly
                                                              and  efficient phase-out of chloridane
                                                              use.  The Supplement provides sufficient
                                                              lime for the use of the volume of existing
                                                              stocks estimated by EPA to exist in
                                                              August of 1907. but will prevent
                                                              unlimited use of such slocks if EPA was
                                                              substantially incorrect in its estimate or
                                                              if individuals possess large stor*piles.
                                                              EPA favors a two-tiered appro ..n
                                                              because it cncouragne 'he use of
                                                              application methods that are believed to
                                                              pose less potential for misapplication
                                                              and  are believed less likely to result in
                                                              indoor exposure than the USPS that will
                                                              be discontinued a fur November 30.
                                                              13C7.
                                                                EPA finds '.hat implementation  of this
                                                              Supplement is consistent with the
                                                              purposes of FIFRA and will not have
                                                              unreasonable adverse effects on the
                                                              environment. EPA has previously
                                                              determined that the agreement entered
                                                              into on August 11.198". which contained
                                                              no limitations on the use of existing
                                                              stocks, was consistent with the purposes
                                                              of the Act. The limitations contained in
                                                              this  Order will not permit any greater
                                                              use  of stocks than that w     the
                                                              Agency has already foun,. -> be
                                                              acceptable.
                                                                The Agency considers the dates set
                                                              forth herein, which  were the product of
                                                              an agreement between Velsicol and
                                                              EPA. to be appropriate for several
                                                              reasons. First, the Agency believes the
                                                              dates chosen satisfy the concerns that
                                                              the Agency may have substantially
                                                              underestimated the amour    stocks in
                                                              the  possession of applicatir  ind
                                                              distributors as of August 11.1987 or that
                                                              individuals may have large stockpiles.
                                                              by establishing a cap on use that would
                                                              prevent the use of significantly larger
                                                              quantities than the amount estimated to
                                                              exist by EPA. Second, these dates allow
                                                               for an orderly transition away from the
                                                               deleted uses (with such uses not  being
                                                               permitted after November 30,1937). and
                                                               eventually from all other uses (after
                                                               April 15,1988). In particular, they
                                                               provide EPA, Velsicol. and the National
                                                               Pest Control Association with an
                                                               adequate  opportunity to notify
                                                               applicators and state enforcement
                                                               agencies of the terms of this Order, the
                                                               dates will not encourage  a hurried use of
                                                               existing stocks which could lead to
                                                               misapplication and greater indoor
                                                               exposures: and they  will allow far the
                                                               ccrtifu.jtion of applicators (use of the

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                  Federal  Register / Vnl  52. No.  212 / Tui""! -y.  Novr-mbiT 3.  TOfT /
                                                                      -12 UT
rx Mine slocks will be B restricted USP
H<: set Ir.r'.h in FIFRA sections 3!d) and 4
.if'-T November 30. 1987). Finally, the
d.itcs reflect iin'urmation provided to
KPA tKit. even though there may well
h.uc I), , n only 110.000 gallons of
i-vis'ir.e Mucks m the hands of
up;.hectors und distributors on August
11 1907. the rr.te of chlordane use has
decreased sinre Ihdl date, and will of
necessity decrease even further after
November 30.1907 when certain uses
will no longer be permitted.
  Based on all thp foregoing, pursuant to
riKRA section 6(a)(l):
  1. The following registrations of
Velsicol's End Use Products arc hereby
cancelled:
  A. The F.nd Use Product described in
Section I1.A.2 of the  attached
Supplement (that product currently
assigned EPA Registration Number 876-
233 bearing all uses  of Gold Crest
Termide other than the retained uses}.
  B. The End Use Product described in
Section II.E.2 of the attached
Supplement (that product currently
assigned EPA Registration Number 076-
63 bearing all uses of Cold Crest C-100
othrr than the reta.ned uses).
  C. The End Use Product described in
Section I1.C.2 of the  attached
Supplement (thai product currently
assigned EPA Registration Number 876-
104 bearing all uses  of Chlordane SEC
Termite other than the  retained uses).
  D. Cold Crest C-50 (EPA Reg. No.  878-
G6).
  E. Cold Crest H-60 (EPA Reg. No.  876-
65).
  F.  California SLN  for crawlspace
perimeter spray (Temide) (CA-810012).
  C. California SLN for crawlspace
perimeter spray (C-100) (CA-810011).
  H. Hawaii SLN for crawlspace
perimeter spray (C-100) (HI-850003).
  2. The sale, distribution, and use of
existing stocks of any products in the
possession of persons other than
Velsicol on or after August 11.1987
bearing Registration Numbers 876-63.
876-85. 876-86. 876-104. 876-233. CA-
810011. CA-810012, or HI-650003 is
subject to the following conditions:
  A. Such products may be sold.
distributed, and used in any manner
consistent with their labeling until
November 30.1987.
  B.  Such products may be sold.
distributed, and used from December 1.
1967 until April 15.1988 only in
accordance with the provisions
contained in Appendix 1  to this Order.
  C. Such products may not be sold.
distributed, or used  after April 15,1988.
  D. Any such products that have not
been u?.ed on or before April 15. I960
must be disposed of in  accordance with
applicable federal, state and local laws.
  It is s<< ordered this 1st rf.iy of
Octnl>er. W.
l)u:ic!.is 0 Cimpt.
D.re: tur. O;f.e o/''''''""-  >p|.
where npr.rss.iry Mix 1-J c./i.ir.s .if
product in 93 potions  (if wafer to
produce a 1-2'^ water enuU.on.
Dilution Instructions  for CoU! Cri->t 11-
00
  Use a .5% water emulsion for
subterranean termites other tlinn
Coptotermes spp. Mix 1 gallon of
product in 59 gallons of water to
produce a .5%  water  emulsion. Use  a l"'-
water emulsion for Copto/vrmi-* spp.
where necessary. Mix 2 gallons ot
product in 59 pailons of water to
produce a lc-o water emulsion.

Dilution Instructions for Cold Crost C-5U
  Use a 1% w.iter emulsion for
subterranean termites other than
Coptotermes spp. Mix 1 gallon of
product in 47 gallons of water to
produce a 1% water emulsion. Use  a 2aJ
water emulsion for Coptotermes spp.
where necessary. Mix 2 gallons of
product in 47 gallons of water to
produce a 2% water emulsion.
  Do not apply to soil beneath
structures which will contain subslab or
intra-s!ab air ducts. Do not apply to any
area intended as a plenum air space.
Check with builder or contractor or
determine if the design of the structure
includes these ducts or a plenum.
  Do not apply to any area inside the
foundation wall which will not be
covered by a concrete slab (e.p . bath
traps, inside surfaces of concrete or
block walls above the level of the sldb).
Cover these areas during application
with polyethylene or similar material.
Do not treat into or through hollow
masonry voids.

Slab Construction

Horizontal Barriers
  Before footings are poured, horizontal
barriers may be established in footing
 trenches. Treatment of the footings
 through hollow masonry voids is
prohibited. Then, after interior grading is
 completed and prior to the pouring of
concrete slabs, horizontal barriers  may
 be  established on soil which will be
 covered by concrete floor, entrance
 platforms,  and in other critical areas
 which will be covered by concrete  slabs.
  In the case of a single-pour.
monolithic slab which does not have a
 separate foundation or footing, an
 overall horizontal barrier would be
 created before the concrete is poured.
  To produce a horizontal barrier,  apply
 the emulsion at the rate of 1 gallon per
 10  square fent to fill  dirt. If fill is washed
 gravel or other coarse materinl. apply at
 l'/i gallons per 10 square feet.

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       1     UNITED STATES ENVIRONMENTAi

       /                WASHINGTON. D.C.
                                                          OFFICE OF
                                                          ur- I- i<_t u>-
                           CCD   Q JODO              PESTICIDES ANO TOXIC SUBSTANCES


MEMORANDUM


SUBJECT:  Chlordimef orm - Stocks at Dealer/Distributor Level
FROM:     Phyllis E. Flaherty
          Acting Director
          Policy and Grants Division
          Office of Compliance Monitoring

TO:       Addressees


     Recently, I received a question regarding chlordimeform.
The question was:  "Would a dealer/distributor be  in violation
of the Cancellation Order for Chlordimeform  if a farmer pays
for chlordimeform prior to February 19 but does not physically
receive the product until after February 19,  1989?"

     Based on discussions with the Office of General Counsel
 ind the Office of Pesticide Programs, this action  would be  a
violation of the Cancellation Order.  The Cancellation Order
states that no one may sell or distribute chlordimeform after
February 19.  Under the FIFRA 88 amendments,  the definition of
the term "sell or distribute" includes "deliver".  In addition,
the intent of the Order was to require the recall  of all  stocks
in the possession of distributors and retailers.

     Please forward a copy of this memorandum to States within
your Region in order to make sure everyone understands that
this is the Aaencv's position.

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