JN1TED STATES ENVIRONMENTAL PROTECTION.

                         WASHINGTON. O.C. 20460
MEMORANDUM

^SUBJECT:  Compliance/Enforcement Strategy  for  the  Federal
          Insecticide, Fungicide, and Rodenticide  Act  (FIF3A)

JO:       Al vi n L. Aim
i          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  all parti cipants.

     The pesticides program is a well established  program that has
evolved  over the years in which States  have a  .Tiajor enforcement
role.

     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
FY8.5 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.

o   Finalize  strategy for conducting data audit and  Good Laboratory
    Practices  (GLP's) inspections.

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                               - 2 -


o  Finalize enforcement response policy for data auaits/GL?  inspe
   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 FIFRA 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 ruleaaklng 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 1f you  have questions  or  would  like  to  further
discuss our plans  for implementing  the  FIFRA  Strategy.
                                  Don  R.  Clay"
                                  Acting  Assistant  Administrator
                                    for Pesti ci des  and
                                    Toxic Substances
Attachment

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         FIFRA COMPLIANCE/ENFORCEMENT STRA71G .

Introduction                                           1
FIFRA Compliance Program Overview                      1
Previous Compl i ance/Enf orcsmerrt 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
  Headq-uarters/Regi cnal Coordination                  2?
  Federal/State Relationship                          29
  Cooperative Certification and ~" r 2 i 11 r •:
    Program              .                             31
  Cross Program Elements              __               34
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
              Inspectloos
  Table IV. -  Federal Pesticide Enforcement Actions

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                 FIFRA Compl i ance/Enf orcamen'1
Int roduc.ion
|^«4MIUM<««i*^«  • > • ^ *•*««•«• i'«^ii«* f* * w * • ™> «• « • ' •  «« v te I * I \w r* w •  w i i w i * i i % 1 » WWI'4
pl iance/enforcement program, a summary  of  prior strategies, the
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 numb-er 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.
r i r 3 A C o mo i 1 a n c a ? r o o r a m 0 v e r
S ~atu t o ry/Recu la vary Requirements
     FIFRA, as amenoea, cjrrenw'iy hai a variety o r .nee." an i s~3 :o P*3-
t.ect 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
  or 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 Child Resistant Packaging 1f 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 orr a food or feed crop.
o Experimental Use Permits (EUP's) for limited field testing prior
  to registration.
o FIFRA  §18 Emergency Use Exemptions by the Administrator upon
  application froa a State 1f certain criteria are met.

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o FIFRA §24(c) State registration for additional uses o •' i -e;;s
  pesticide within a State to meet special local nseas.
o Cancellation/suspension by £?A of pesticiaes *nicn ca.ie ^.T-eason-
  aole adverse effects.
o Federal  registration of pesticide or device producing est aa 1 i s me?t 3
o Submisson of annual reports to E?A and maintenance of books ana
  records  by each registered estan1isnment.
o Establishment inspections.
o Certification and training for users of restricted use pesticides
  by the States with plans or EPA.  (Pesticides classified for
  restricted use may only be applied by or under the direct super-
  vision of a certified applicator.)
o Use in accordance with the label.
o Efficacy requirement for pesticides.
o Prohibitions of statements or graphic representations on the label
  which are false or misleading.

Impl_e-nent3ti on

     FIFRA was first enacted as the Federal Insecticide Act in 1.910.
Since then, it has undergone major revisions which have resulted in
changes in the compliance/enforcement program.

     Traditionally, primary responsibility for enforcing tne require-
ments of FIFRA has re-sided with the Federal government.  I*. 1972
however, Congress paved tne way to sr, ift resoonsi311ity t: tie 3
by amending FIFRA to provide for F edaral / 5 : •: a cooperative ,:--::-5-3T
governing  pesticides enforcement and applicator training ana certi-
fication.   Congress furtne-r strengtnenea tne respons i o i ". i ;y or" c.-.e
States in  the 1978 FIFRA amendments which establish  the presumption
that States, under certain circumstances,, shall have primary respon-
sibility for bringing enforcement actions against violators of
pesticide use requirements (primacy).

     Most  States who enter into a cooperative enforcement agreement
with EPA und.er §23 automatically obtain primacy as do States which
have an approved pesticide applicator certification  plan (§4)
which also meets the criteria under §26{a) for adequate pesticide
use  laws and Implementing- procedures.  A State which has neither a
cooperative agreement nor an approved plan can also  obtain primacy
if it has adequate laws and procedures governing pesticide misuse as
requ-ired by §26(»).

     Section 27 of FIFRA provides for:  1) an EPA response to a
complaint alleging a significant violation of the pesticide use
provisions when a State does not commence appropriate enforcement
action within 30 days of a referral from EPA; 2) rescission of primacy
1f the Administrator determines thit a State is not  carrying out its
enforcement responsibility; and 3) action by EPA during emergency
conditi ons.

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     The 1972 amendments to FIFRA require the certification of
applicators to apply or supervise tne application o* :es;:;:iies
classified for restricted use.  Congress exoected States to certify
applicators and autnorized funding support.  The State -cooerative"
Extension Services were to be utilized for the t r a 1n i - g of pesti-
cide applicators * i t n EPA funding support.

     As of October 1983, all  but 4. States have funaed cooperative
enforcement agreements; all but 3 States have been granted use
enforcement primacy; and all  but 2 States have aporoved 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, talcing
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 regulatio;
development support.


Previous Compliance/ enforcement Strategies                    *~

Pre-1980 Program Reassessment	

General Enforcement of FIFRA
     While the F I F \ A a n f o r c e m e r. t p r z , .- a m * a s located i i t .-. = 'J • : t 2 j
States Department  of Agriculture (USDA), the enforcement orogram 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 was 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,
c-heraical deficiencies, nonregistration.  There was no authority  to
take enforcement action against improper use.  Criminal action was
    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 pesticides along with provisions for certification
and training (C i T) of pesticide applicators.  As a result, the
Federal program shifted to Include enforcement of the label use
directions.  The use of civil penalties became th-e backbone of
the enforcement effort.  States were responsible for developing
C & T programs based on EPA regulations and obtaining approval for
               from €PA.

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                                -  4  -


     In  1974, £?A  entered  into  pilot cooperative  a:ree-e.-. :s *'t:
5 States.   Prior to  this  ti.ne,  tne  States and t n e F e •: =.- a i •; o v e r n ,
had separate  programs  with  little interaction.  7-. e :-, itial e mo .1 = 3:5
of the cooperative program  «as  joint enforcement  .vitn  tontinusc
Federal  presence in  those  States  with  agreements.

    . The Federal enforcement  program became nore  Decentralizes i-
February 1975 when Headquarters announced a program to  waive con-
currence for  routine civil  cases, excluding use cases.   By 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
trf Hea-rfquaTteT-s c-onxurrence rn tire  enforcement of misuse  cases.

     The 1973 amendments,  under certain  circumstances,  gave primary
responsibility for use  enforcement  (primacy) to States.   As more
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 State personnel, disinfectant/device
testing, import/export  surveillance, and data audits.

     Guidance for  the  cooperative agreement program was  issued
annually.   Until 1930,  strategies empnasizaa a graaual  shifc from
activities  related to  product compliance to tnosa non'itoring use.
Guidance documents assigned percentages  to various a c t i / i tits
including agricultural, n o n a ~. r: c u 1 ' u r = 1  2.". •: e *..: e - i -n e n t *"  '•> '--
inspections;  producer  establishment, marketplace, import, certified
applicator  r e c o r u j inspection:*; anu rsscriwCsu us<= p d j c i c i u e Dealer
inspections.  The  percentages correlated to the amount  of total
workyears 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  Programs  (OPP) independently of the  compliance program.

1980 Program  Reassessment	

     In June  1980. the  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; anjl
  b) improving program  evaluation through a better information
  retrieval system, unlfoT-m evaluation  standards, periodic progral
  evaluations, and appropriate program  modifications.

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o Ensure tnat eligiDla States receive primacy and adequately
  the public.  This goal was to ae achieved by: a) pro~u" :atiig an
  interpretive rule on primacy standards; b) p ro
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                                -  0  -
     Application  of  the model results in four products:

1.  A  list  of  pesticide use problems ranked by thei
    contribution  to  h a r rn from pesticide use/misuse i rvc i : 2 .n 1 3 .

2.  A-  listing  of  pesticides ranked by their relative c on: ri but '• :-
    to harm from  pesticide use/ misuse incidents.

3.  A  list  of  program  activities to be carried out to deal wi-'-i
    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 ttie 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
F Y 3 4 guidance.  Because narm is likely to oe greater for use-ralatea
activities and the compliance rate is generally hign for non-use
related activities,  t~e ranking 3 r o •: e d j r e suggests that 25* of
available inspection .- 3 3 o 'j r c a s be ali:c2t2J to non-use r a 1 a t e a
activities.  Under the ranking procedures suggested for non-use
pr'wP't'cS, teO m£ i  I d ,~i c c lii j i\ i to j r ~, ,T g p i* i o r i cy i j a j j i 9 ii - G ; n \, \\ <&
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
retrieval 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) tfte Establishment Regis-
tration Support System (FRSS) which contained "FIFRA §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 (FIFKA and TSCA Enforcement System).  FATES con-
sists of five  subsystems which operate independently with cross
referetic*

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o Pesticide establish men* registration and production -aborting
o Inspections and sampling
o Case management
o Grants information
o Contract inspections

After a feasibility study in 1979, a system design phase was
initiatea in 1980.  Development and implementation *as b-egun in
early 1981, and by October 1981 FATES was operational.  Regional
system installation and ussr training was accompl i si.ed 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 cotnpretieTi-
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 FYS3 cooperative agreement guidance.  The protocol was developed
1) to ensure that all State cooperative enforcement and C 4 T programs
woula be evaluated, annually by tin a Regions according to uniform stan-
dards; and 2) to ensure that appropriate pesticida usa problems woull
ba addressed in State pesticide applicator training and certification
materials.  This protocol was developed for u 5 a in ~ Y 3 3 a.-: a *:' 1 oe
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 ths 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 iddreused 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, ttie Agency determines
whether a State should be granted primacy or wh-ether its use program
1s 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 enforcenent programs.

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                               - 3 -


     On May 11, 1981 EPA promulgated a pule (4.5 FR 25353' govam
procedures to be followed by the Aaministrator in rescinding
ppiraacy.  'Jndep these ppocedures, whenevep the Administrator makes
a determination that a State is^iot adequately discharging its
use enfopcement pesponsibi1itias, ne nust send a notice to the
State specifying the deficiencies in the State's use enfopcement
program.  If aftar ninety days from peceipt of a notice by a Stats,
the Administpatop finds that the itate has not coppected the
deficiencies set forth in the notice, the Administpatop may pescind,
in whole OP in papt. the State's ppimapy enfopcement pesponsibi1ity
fop pesticide use violations.  In practice, if someone complains OP
deficiencies ape discoveped duping an evaluation, the Regional
office will contact the State and try to resolve the problem prior
to fopnal pescisslon ppocedupes.  Genepally, few ppoblems have apisen,
and those wepe satisifactopily pesolved.

Tpaining/Guidance

     Throughout the development of the cooperative agreement- PPO-
gpam, EPA has placed a majop emphasis on training state pesticide
inspectops.  State inspector tpaining has been accomplished ppilnapily
by the Regional offices through fopmal training sessions and thpougn
having exp«pienced EPA pesticide insoectops assist State inspectops
in the field.  In addition the National Enfopcement Investigations
Centep ("EIC), in coopepation with the Co-plianca Monitoring Staff
(CMS) and the Regions, conducts use/mi s-jss "iivesftgation wo~:
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Certi fi cat ion and
Training Program

     In FY81, OMB transferred the program to the cone 1iance/
enforcement program.  This transfer provided an opportunity to
better coordinate the two programs.

     FIFRA provides that certification of pesticide applicators
be accomplished under State Certification Plans aoproved 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 Color&da* SLE2 fails to provide applicator training.  In
each of these States, £?A has established programs in the absence
of State activity.

     Three Federal agencies, the Department of Defense  (DOD ) ,
the Department of Interior (DOI), and USDA, 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.

     3 a s e d on operational experience, there has been a  need for s:me
changes, and certification plans have been amended in response to
these needs .

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

     EPA has worked with USDA to develop training material.  There
is need to periodically update the material in order to  incorporate
information on new technology.  Existing training material  is
cataloged at the USDA BeltsvUle library.

Additional Activities - Federal Program	

I-n-put tnto Devel opirerrt of Me*- ftegul atlons

     To ensure that new regulations are enforceable, CMS participates
and assists in the development of regulations or other  regulatory
actions such as suspension/cancellation orders for which the Office
of Pesticide Programs (OPP) has the lead role.
   *Col-ora.d.o has 1n.d1c.ated an Interest in establishing a program,
which will initially cover only commercial applicators.

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General	

     As mentioned previously, the Federal ro"!e sni'tac:, as ^c~e
States received grants, to the oversight of the coooerative progr*.?,,
enforcement response  for State referrals, enforcement 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.

Oata 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 haa
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,
FDA conducts inspections at laboratories whiah conduct haaltn
effect studies.  £°A inspectors primarily condjct audits of environ
mental studies.  E?A sc.i <=nt i sts participate on audits as aoorcp
A Data Audit Panel within Office of Pesticides and Toxic Substai
(OPTS) targets inspections, reviews reports, and r'ecom-
— a « J - ,^^^n^«4a-3  , ,.» ^ „ ., r
,..»..-j -r r> • - r ' • « - =  .«.«.„...».

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 tfie 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
averrag* of 4375 Notices of Arrival fcar« be-en received and 670
inspections of imported products have b««n conducted for the past
few years.

Efficacy Testing	

Disinfectant Testing

     The Federal program for disinfectant testing, which is no
longer active, ia-v-olved eff1.ca.cy testing of hospital disinfectan
Suctj testing is Important considering that failure of hospital

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disinfectants can contribute to the incidence of in-^-tions a HO rig
vulnerable patients and result in unnecessary and u -•;-.: w •>-:; exrcsu-e
of hosoital staff to pathogenic organisms.  b?3's 3alt3vilfe
laboratory formerly performed efficacy testing on aoout 200 sables
per year.  The failure rate ranged from 45% of 111  sa.-oles in  'i 530
to 72% of 40 samples in 1982.  the Seltsville laboratory suspencea
tasting of disinfectants,  sanitizers,  sterilizers,  and germicides
in Octcoer 1932 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 Canter 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._  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 el ectromagneti sm.  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 marketplace.
Rodentlelde 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 1n ttils program by coordinating the sampling,
chemistry testing, efficacy reviews, and enforcement response, if
any, for the rodenticides.

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                               - 12 -

Monitoring of radar2! Srray Programs	

     The EPA through trie Federal enforcement program or t.-.e
cooperativ-e State programs routinely monitors spray pngra.os
funded by Federal agencies.  For instance, applications"^/
for-hire 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 tna 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 ipmpnance	

Regulated Community	

The following is a list of known members of the regulated cosrsuni ty :

a Number of Registarad Establ ishrssnts                     11,000

o Number of Applicators Trained and Certified

  Private                                              1,500,000
  Commercial                                          -   435,000

o Numter of Laboratories Conducting FIFHA Studies            -03]

o Number of Notice of Arrivals Received in 1982 (imports)  5,01-

o Number of Export Notices received annually (approximate)    75

o Number of Experimental Jsa Permits Issued in 1982          441

o Number of §18 Exemptions issued in 1982          "         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
perMc-itfe 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 or farmers.  Although the unknown
categories represent a large number of persons, "The overall impact
of violations by this group which go undetected 1s 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 or product type violations which impact a large number
of people If left undetected.  Violations by private users who a.<-
uncertified generally affect a more limited population.  In addi
violations by users wnlcfr result 1n serious harm are likely to S>
reported to the Agency.

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                               -  13  -

Inspections and  Actions
     The shift  from a  Federal  to  a  Stats  program  has  resj'ted  i •*.  21
increased number  of Inspections and  increased  field  Dr=sen;e.   A
coinpleta data  oase  on  enforcement  actions  wnicn  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  inspections  resulting  in
actions was  13.1.   Violations  figures  for  specific  types  of
inspections  indicate  a higher  rate  of  noncompliar.ee  fir  use  related
requirements  than  for  non-use  related  requirements.

     The number of  Federal  inspections  for FY81  and  FY82  was  2254
and 2021 respectively.  In  FY81 ,  the  number of enforcement  actions
was 755 and  in  FY82 the  number was  1139.   These  figures  include
actions oased  on  referrals  from the  States.  A detailed  breakdown
of the numbers  of  inspections  and  actions  can  be  found in Tables  I,
II, III, and  IV.   (See Appendix.)

     Soth SPA  and  the  States  ara  collecting a  large  body  of  data
related to specific types of  violations.   The  Agency  will inc'luae
this data in  the  FATES system  and  then  use the system to  better .
define major  violations  and specific causes of violations if
funding is available  for system modification.

Goa 1 s and P.-i ori ti e s

Long Te rm Goa1s

     Long term goals  for the  FIF.RA Compl i ance/Enforcement Program
are listed in  order of priority below:

o Expand FATES to  include State data and  assure  completeness  of data.
o Develop a  predictive model  to set  priorities.
o Ensure that  all  States participate in cooperative  enforcement
  agreements  and  the  C 4 T Program.
o Improve EPA-State commuirt cation  systems  through the use of state  of
  the art technology,  e.g., use of electronic mail.
o Provide guidance  and training to the  Regions for  data  audits/
  laboratory  inspections and case  preparation.
o Conduct periodic surveys of pesticide use to improve priority
  setting system.
o Continue refinement of program, management for th«  cooperative
  enforcement  program, the C S T  program and Federal  program.
o Improve program evaluation.
o Ensure the  adequacy of the C 4  T program.
o Review certification and training materials.
o Ensure adequacy of Federal  Compliance/Enforcement Program.
o Promote programs to prevent violations of FIFRA.
o Provide technical and legal  support to States.
o Continue to provide training for State inspectors and chemists.
o Continue cooperative relationship with States.

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                               - 14 -

o Develop compliance monitoring strategies and enforcement
  response policies for new regulations and susaensions'
  cancellations as appropriate.
o Update the Pesticides Inspection Manual.
o Consolidate FIFRA enforcement reoonse policies.
o Revise FIFRA §7 establishment "registration rule ana reporting fern
  to improve tne usefulness of data in the system.
o Expand formal referral systems within the Agency.
o Expand formal referral systems with other Agencies.
o Improve referral system between the Regions and States.
o Expand work with the press and special  Interest groups.
o Continue integration of inspections.

Near Term Priorities	

     Priorities for the FIFRA compliance/enforcement program through
FY85 fall .into the following management,  compliance monitoring
enforcement respons.e 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 tor
  ensure that the documents are enforceable.  It 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 dsvel's^^d.
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 State-
o Provide training for State Inspectors and chemists.
o Prepare additional policies for the FIFRA Policy Compendium, as
  needed.
o Promulgate 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 applica-
  tions of restricted use pesticides.

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                               - 1 5 -

Compliance Monitoring	

     Program guidance indicates that generally 75* z~ : ~:: ecti :n
resources should be directed at use problems and 25v, =-.  :~ocu:t
related priority problems.  The priority setting g'j i :a-i c? 13  desi^nec:
to be flexible, allowing a shift in inspection targets -rom year to
year based an shifts i r, State specific problems ana  ne^  r!-3A
regulations.

     In addition,  the Federal program will  emphasize the 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
     The Agency attaches the highest priority to responding to the
following instances of noncomp1iance:

o Violations related to those priority use problems which
  EPA and the State have agreed  to track under primacy and
  for which the State does not take approp-riate action.
o Violations related to other priority use probla.-s est ai 1 : shed
  by the States or EPA.
o Submission of false data to EPA in conjunction with pest:;:.:*
  regi strati on .
o Sale of Restricted Use Pesticides to uncertified applicators in
  Statas with Federal Prcgrams.
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
  ckan-gin-g  technology.
o EPA and States will continue to certify new applicators.
o EPA will  prepare guidance to encourage States to address major use
  problems  in C 5 T materials.
o EPA will  prepare guidance which ensures that State C 4 T 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 noncompliance,
certification and training, Headquarters/Regional coordination,
Federal/State relationship, and cross program effects.

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                               -10-
Comoliance .Monitoring Plan
Obi acti ves
     T.he basic objectives of the compliance moni tor:-ig c'an jre:
1) to provide a visible enforcement presence which wi'"; encourage
voluntary compliance; 2) to collect evidence to support enforcemen-
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 noncompliance; and 4) to discover
problem areas requiring resolution fhrxjugti 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 wnetner
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 «ff«ctive.  They are generally ussa wnen
purposeful noncompliance is not suspected and the likelihood of
response is good.

     On-site inspections are the major method through which £?A
monitors compliance wit!*. FTrSA.  Ti-.ass i nzpacti z~z ±r* cc.-djcta-
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 high 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 T?A 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
1) consent of the owner or hts agent* or 2) with a warrant based
on probable cause that a violation has occurred, or is occurring.
Probable cause can be based upon a detailed allegation from a
reliable source  11nt1ng 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 * o detect unless an inspect:" -3
during actual  use or soon a.Ttar t.ie use of the ? e s t ; c : .: = .
fore, use inspections are conducted in resaonse to a  cc-:::
referral  or during tne actual  application of trie p -2 3t ' ;• -e .   '-egi-
timate complaints/referrals regarding pesticide Disuse .-nay 32
ineffective if they are-not made and investigated oromotly oecause
the evidence,  especially in the case of highly toxic  organ oonosonates
will no longer be there at trie, time of tne 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 ctrmmercial or private applicator is  going to make
a pesticide application, they  make appointments to conduct the
observations.   It is, therefore, not as likely that instances of
knowing and willful misuse will be detected on a planned inspection,
as on an investigation conducted in response to a complaint.

Routine Inspections _
     EPA and the States can use on-site inspection to determine"
with relative ease and at reasonable cost whether an establishment
has met its establishment registration or reporting requirements,
whether a product is appropriately lao-elea,  or wnather scientific
data submitted in support of a pesticide registration correctly
reflects the testing which was conducted and t>.2 results.

     Since most States have regulations requiring dealers of
KU? ' s to keep records of tneir idles, i: is  relatively eaiy fjr
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
problems 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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Targettinq
     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 persons 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 potenti a 1 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 p roduct/f a ci 1 i ty 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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                                -  19  -


expand Referral Systems
With Other Age_nci es	

     While trie Agency Has referral systems  for  sseci'ic  tyses of
products or violations witn FDA,  Consumer Product Safety Commiss::;-
(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 systems.

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 Soecial_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 req'J i rements .  Kncwled'ge of FIF3A  and State pest.ci.e
1 2.vs have consistently resulted in discovery o* violations of both
laws.  Because evidence of pesticide misuse may rapidly  disappear,
ic is particularly  important that £?A and the S;d:es expand t.-sir
efforts to work with such groups  as farmworkers to educate them
about basic evidentiary requirements and the -need to contact the
government as soon  as possible  after occurrence of the alleged
misuse.  Efforts made 1n this area continue to  be restricted by
resource levels.  CMS has issued  a Complaint Form, which was
sent out as an update to the FIFRA Inspection Manual, to facilitate
the reporting of complaints or  referrals.

Integration of Inspections

     To make the most effective use of resources,  both EPA and the
States currently conduct inspections based  in part on geographic
proximity of the targets.  Both will continue this approach.

     EPA wm also  continue Its program of integrating FTFRA and
TSCA data audit/laboratory inspections.

Inspection Frequency
     In the past EPA and the States were to inspect establishments
manufacturing general use pesticides every 5 years and those manu-
facturing RUP's every 3 years.  In practice, this has varied based
on the number of establishments existing in a State.  EPA has moved

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                               - 20 -

away from requiring  a  specific frequency in its guidance.  Iistaac,
trie Agency suggests  that frequency foe estaoiisnea tirou:? :-ie
priority setting system.  This is true far misuse as •*•*''. =£
estab 1 is nne.it  inspections.

     Laboratories are  expected fo oe inspected under i.-.e data auait/
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 more information
is needed for a possible enforcement case or when violations
h 2 v e baan fo'j"J i *? d t h a ^anion'S*s*a da*3'*"'T!'?os * *? * * a n o * n 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.

Inspecti on Qua!Ity	
     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 SPA
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
will 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 program durl-n^ raid-year and end-of-year reviews.
This revvew activity «wi 13 continue.

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     In accordance with the Agency's Quality Ass-jranca   I ^,'  raqu-p
ments, States receiving grant money through tne  coooe r-» c i ve  enforc
ment program must develop QA Plarcs covering botn coma 1 1 a^ce  incm: c o
and sample analysis.  These QA Plans must be sub^lttec  to  tne  Segi
Quality Assurance Officers annually for review and approval.  Tie
Compliance Monitoring Staff, with the approval of the  EPA  Quality
Assurance Management Staff of ORD, has provided  guidance  to  the
S-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 is to ensure that the regulated community is aware of
the requirements of FIFRA and related State pesticide laws and
understands what it must do to  comply.

     Since neither EPA nor the  States have sufficent resources ta
inspect every member of the community regulated under FIFRA, both
must depend largely on voluntary compliance.

Tool 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 tne pesticide 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 available resources.

Other education programs.  These programs are designed to promote
safe pesticide use.  An example is Project SAFE, 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 taac.n aerial applicators better ci'::-2t
tecnniques to minimize  pesticide drift and to obtain o:ti:~=*
control with the minimum amount of pesticide.  The~ = r.av? tee'1
three trainer fly-ins which involved approximately  3 States.
During the next phase of the program, these trainee specialists,
mostly cooperative extension staff, will be conducting fly-ins for
aerial applicators in their States to help the applicators calisrata
and apply pesticides in the most environmentally effective manner.

Farmworkers Program

     Several y-e-ars -ago, th-e Agency initiated a .pro-gram to ev.al-u.atJ5
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 .vorxgrouo nas : e a.".
formed to revise the Worker Protection Standards at 40 CF-3 i'C.

     Language for use on outdoor a jri ;-l tj ra 1  ,;"«----- -- ~a = t
the standards is being  developed under OPP's Label Improvement
Program.  OPP is also considering a aual language requirement,
English and Spanish, for highly toxic products labeled for agricul-
tural use to help assure compliance.
                                                     •
     The Agency continues to hold meeting with farmworker groups
to discuss farmworker problems and seek solutions.  CMS included
in the annual cooperative enforcement agreement guidance a request
that States consider Farmworker exposu-e in setting priorities.

Publ1cat1ons
Compliance Policy Compendium.  The Agency has developed and will
continue to expand itscompendium of FIFRA Compliance Policies,
These policies Interpreting compliance requirements are available
to the regulated community as well as the Regions and the States.
   *
    F1y-1ns are programs 1n which aerial applicators actually fly
their airplanes to the training site.  They then fly over a
designated area and apply water containing a dye.  The spray
pattern 1s •**»»« •w»iw»«»4

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                               - 23 -

   sanded and Cancalled 3 a s t i c i 2 a s Booklet.  7 '-i •; 3 boo
    arad oy CMS in 1977.  It was compiiai to sunna ••; 2 a a-: -' »r- -•/
       actions on pasticiias which nave bean suspense c, :i-:cal'ac',
or otherwise restricted.  It was aesigned as a q-j:-:< -e'e-e-ca  •:':-: a
for use by pesticide inspectors but is available to t.-a pubVt.

Publication of Results of ttajor Testing Programs.   *n Octooer  1 93C ,
CMS issued a puolication called ihelnvestigation of Efficacy  a ? c
Enforcement Activities Gelatins to c i ectrc^icrat : :  .^ast Control
Devices.  The" resul ts 37 tFi u f t rasoni c test i ng program will  also
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 FIFRA, EPA publisnes
enforcement actions taicen against violators.  It is believed that
the Notices of Judgment have some deterrent effect.

Press Rel eases .  Thasa ara ganarally issued whan major violations
occur or if puslic attantlcn has baan  focusad en a  casa.

Personal Contacts

Compliance Inspect ions.  Discussions of regulatory  requirements
during i nspect i ons aTTT provide a system for educating trie ragulatec
   munity concerning specific FIF3A requirements an.^ tne rae-:  to
Public Presentations.  EPA personnel give presentations and
3 j »•" i c" pata in p a ? a '  diiCuttior. 2 it i r. i u 2 1 ™ " c o ~ f 3 ~ 3 ~ c = 3  ^ s .n i * ^ r j
and other public meetings.

Noncompl i ance Response Plan _

     The objectives of a program for responding to instances of
noncorapl 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 noncoopl 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 res-ponse is
«   liable to the Regions and States in the 1983 FIFRA Compliance/
   orcement Suidance Manual and in the Civil P-malty Policies
   ted on page 25 under the Administrative Civil Actions Section.
Inspections will continue to be conducted with increased frequency
at those establishments with a violation history.

-------
                               - 28 -
^s^'jsal  to Acteat  Data  f-om Laboratories 3ef'jsi"j '. •*;;?••.' o? s

     This policy is  stated in the final  FIFRA Good Laboratory
Practice Regulations (GLP's) which are to be pro^u ' ga tea in FY3-i.

Susoensi on/Cancal lati on of Real strati on
     This is an action which may be • consi c!e red if the statement
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 §157.3) 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 Federal  Agencies are fcun- in viclat'cn of -
the EPA does not issue penalties.  This is in accordance with txe-utiv-
Order 12038, Federal  Comoliance With Pollution Control Standards,
which established a government wide program for ensuring Federal
facility compliance with pol1ution '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 1-etter 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:

             Assistance - to ensure cost effective and timely
         ance.

o  Compliance Monitoring - to -monitor actual compliance

o  Fiscal* Plamrtnq Assistance - to assist OMB 1n evaluating budget
       TT^^^"^^^!"'^^^"'"^""""""•^"^r^—-^ .. ,..4*t» •* M!
       6a fa ^  t ui IMIIMA »»•« «.Otup >j «•!••• |« w t
       mnoitor use of funds.

-------
                                -  30  -


 Cooperative  Enforcement  Program	

      As  the  cooperative  enforcement  program has ev: ;/?•:,  t'ie  S:itas
 with  agreements  have  accepted  increasing  responsiblity  ina  now  snare
 fully  in  all  phases  of the  program with  EPA.

 C o mo 1 i a n c e /E n f o r c e me n t 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
 spray  programs  in  ttie  Stat«.   (Th-e^e major  spray  programs  are
 usually  funded  by  Federal  agencies.) In  addition, EPA through
 iNEIC  provio.es  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  reefer  all  violation's  of  only Federal  law  product and  establish-
 ment  registration  requirements  to EPA for enforcement action.
 Where  tnere  is  a  violation  of  both  State  and Federal  law,  a Staze
 may take  enforcement  action  itself  or refer  the case  to  EPA if  it
 is  unv/illing cr  unable 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 interpreting  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.

 StatB  Program  Oversight	
     EPA  has  primary  responsibility  for  cooperative  enforcement
 programs  oversight;  however,  the  States  are closely  involved  in
 this process.

 Program Guidance  and
 Compli ance/Enforcement  Pri orlties

     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,
 th-ese  are  only for consideration  by  the  States  as they develop

-------
                               - 31  -


tneir own annual  program priorities.   Specific  outputs  * : -  c;~-
pliance/ enforcement  activities  ar*  negotiatea  on  t-a  0:3:3  zf tie
Stats priorities  and  productivity  factors  in  the  guidance.

Program Evaluation

     Major elements  of the  3 e g tonal evaluation  of  State  programs
1nclude:

o Semiannual  reports  by the States  of  their  accomplishments  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.

Feaeral Program in  Non-cooperative  Asree^ent ' States

     In Colorado, Nebraska, and  Wyoming, E?A  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  1n  accordance  with
FIFRA' §23.  Ten Indian tribes have  received  EPA  funds  to  develop
Certification Program*,  Under ftre  C 4 T prograa.  over  1.6 ail!ion
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 ccntinue to conduct ce rt i *i :at * on pro 3-2-3 • ".  States
without c e " t i • i c a t i o n plans.  Both EPA a n •• j States -: c = : i : -»i n-; -; g
material and  -information to ensure tnat  applicators';-:  a.vare  c~3
changing technology.  EPA and States will  continue t ? ce-tify  new
appli cators.

Proaram Guidance and C 4 T Priorities
       In the past priorities for the C & T program have been the
approval  and, when necessary,the amendment of State certification
plans along with the maintenance of training programs.  Two studies
of aation-al scope were performe-d-  Ons Involved pre and post  testing
of applicators in North Carolina; the other consisted of a  comprehen-
sive telephone survey of attitudes and practices of private applica-
tors in five States.  On-site evaluation of State program effective-
ness has  been performed by Regional personnel without specific
guidance  from Headquarters.  Headquarters personnel accompanied  by
Regional  personnel have visited States and reviewed certification
files.  However, there has been no requirement that EPA monitor
certification and training sessions and evaluate content, presentation,
and effectiveness.  A recent GAO study found in two States  that'
enforcement misuse information was not incorporated in C 4  T  sessions
and that  commercial applicators were not fully tested against the
EPA standards of competency.

     In response to the recent GAO report, EPA intends:  \] to
ensure that enforcement problems identified in tne oriority settin
process are addressed as appropriate in certification and training
materials; 2) to ensure t?:at State programs require appli caters  tc
meet Federal standards of competency; and 3) to review and  revise
training  materials as appropriate.

Program Evaluation	
    .Major elements of ttie Regional  evaluation  of State  programs
i rrclude:

o Semiannual reports by the States of their accomplishments
  compared to the types and numbers  of activities projected
  1n the grant agreement.

o Midyear and end of year evaluations based on  uniform evaluation
  protocol which contains botfc quantitative and qualitative  evalu-
  ation factors.

Coordination with Enforcement	
     Stronger emphasis will be placed on transferring information
from the enforcement priority setting process to the  certification
and training program for Inclusion in training and certification
naiertaLs..  To accomplish this, EPA will include in Its  annual
Cooperative Agreement Guidance a request that States  establish
a management mechanism which will assure that Information on
priority pesticide problems *re Included In tne State's  certifi-
cation and training programs, as appropriate.

-------
                               - 33 -

U3-d219 of Materials	

     The core manual  and various category manuals we~a .~ec;
updated to reflect changing needs and technology.  Cor:es
manuals *ill  oe printed by the State Cooperative Extension
puuiications ror a i 5 u n OUT; i on ana 5aie.  inererare, wm le 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  1s a.bo.ut t.o 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.

Indian Tribes	

     Ten Indian tribes have received EPA  funding assistance to
develop certification plans and some draft  Indian plans  are no.w
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 £?A must establish Indian cartification
programs.  There is also the possibility  of some split  options,
such as, States issuing  certificates and  EPA 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  these States
develop and submit certification plans.   Colorado has recently
indicated its interest 1n 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 am where the applicator can apply pesticides, I.e..
the State Issuing the certificate or States with reciprocal
agreements.  However, because some Federal applicators must work
in several States, ofte-n on snort notice. EPA allows Federal

-------
agencies to develoo  certification plans for their e-so/ees.
Applicators certified under* Federal agency plans cai izo'-j
pesticides anywhere, but this certification is limite'i to of
auty functions.  To  date, three Federal agencies, 003, USDA anc
DOI, have approved Federal agency certification plans.

Cross Program Elements		

     The pesticide program impacts regulations and enforcement of
other State and Federal environmental  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 effertively maice referrals
to other programs.

IntraAgency	
Toxic Substances Control Act (TSCA)

     Since CMS is responsible for both FIFRA and TSCA compliance/
enforcement, activities under both programs are closely coordinated,

PCB's (Polychlgrinated Biphenyls) in Pesticides.  Use of oil con-
t a i n i n g any FC3's a! a pesticide carrier has 5Te n prohibited under
TSCA.  Additional TSCA regulation of chemicals may have a sinil
impact on pesticide registration and use which require monitor
under both Acts.

P_9Stiefde Precursors and Intermediates.  Hazardous pesticide ore-
cursors, and intermediates wnicn are not directly regulated under
FIFRA are regulated under TSCA.

Pesticide Wastes.  The TSCA §6 Oioxin Rule regulates waste from
the manufacture of 2,4.,5-Tri cnl orophenol and its pesticide deriva-
tives*  TSCA Dioxin Rule inspection targets were derived primarily
from information collected under FIFRA Section 7.

Data Audit/Laboratory Inspections,  The FIFRA Data Audit Laboratory
Inspection program directly complements the TSCA program in that
information is shared and inspections under FIFRA and TSCA are
coordinated and conducted in conjunction with one another whenever
possible.  The programs are formally coordinated through an OPTS
Data Audit Panel which has representatives from OPP, OTS, and CMS.
The Panel deals w-fth targetting inspections, cas-e evaluation, and
enforcement or regulatory responses.

-------
                               - 35 -

  azardous Waste
     Pestle-ides are a major constituent of the -.vast as at a large
number of hazardous waste sites and information en  registrants
ana producers is needed for clean-'jp cost recovery  and associates
enforcement actions.  Information on oesticiae manu f act j rers ", = 3
been provided to the Office of Waste Programs En -or cement as part
of the Agency's dioxin monitoring orogram.

     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
InterAgenev
Data Audits/Good Laboratory
Practice Inspections

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

So ray Programs

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

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  -
     EPA worxs with  other "edaral Agencies  of  tnei-  -euu
the aevel opment  and  i~s 1 ementat i on  of C  i 7 prscra-s.  C
DGQ, USDA, and 001 's Bureau  of -Land Management  -^ave  approver C 4 "
programs .

Food C : .T t a r^*' .1 a t :' 3 n

     USDA an-d FDA monitor pesticide residues  in food.  3otn
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.

P rogram  t va Tuat i on

     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 achievi
compliance when  it- has  developed  1) an ac equate aata oase for
Identifying .Tiemoers  of  the regulated community  and 2} predictivl
models designed  to select those  members  most  li
-------
Compliance by th.e Regulated C
      he extent of compliance for tie "eguiatec : : --yj i
         to a limited degree by  tne fallowing f actors:
o Number of aoplicators trained and certified.
o Proportionate number of estaol i snments '
-------
                              -  33 -
Program Modification
       c ? A  uses  a a t a  from  FATES,  State  Program 3 2 v: e * s, 3 a •: i 3 r, a ;
reviews and  the  overall  program  review, to (nodi";'  t ~> e  ^o^oVjica'
enforcement  program  as  necasary  and to  give  input  to  OP° concs-^'-i
regulatory  cnanges  necessary to  facilitate comoliaice  monitoring,
enforcement,  or  compliance.

F U t U r e 3 u i ia n c e  "

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

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

o FIFRA C o mp 1J an ce fro g.r arc..P..Q 1 icy C omo e n d i u tn further  defines the
  requirements of FIFRA  regulations.  Currently there  ars twenty
  such policies  in the  compendium and three  under  review by  the
  Regions,  the States  (through SFIREG), and  the program office.

o FjF_R_A_ Inspection Manual  provides information on  conducting inspeC'
  tllTns",coil act i rig  sampl as , cha*n-of-custody procedures, p-ep
  suooort documents,  and other Indorsation necessary  to coiduc
  FIFRA inspections..   This  document snould be revised  if resources
  are available.

o g_! FR A _S_n/ o r*: STTTQ nt  R ?s o on s a _P o 1 \ ; y.  Several additions f5 the
  ori gfnal  p en a 1 typo 1i cy  h a ve bee n developed over the years to
  reflect amendments  to  the law.  These will all  be combined into
  one comprehensive  document.

g FTFRA Compliance Strategies.   The FIFRA Compliance  Strategies are
  developed  for  all  rules  promulgated under FIFKA.  A  compliance
  strategy  identifies  the  (a) requirements of the  regulation, (b)
  the type  of act-fons  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 QuaTlty Assurance  Plan Development Suldance  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  N€IC  1n developing a model  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 Is Included 1n fhe Appendix of tne FIFRA Cswpliasca/
    Enforcement Guidance.

-------
- 39 -
   APPENDIX

-------
                                                      I IIMCASE  FLOU
                                          I NEUTRAL
                                                  (FOR CAUSE
    NO
  ACTION
                                                        fTWcTTMl
                                                             J.       (30 days  to determine couipT iance/noncompl lance)

                                                       (COMPLIANCE)               I  uoN-coMPUAijTi; I
                                          (60 days  to prepare action)
                             | ADMINISTRATIVE ACTIONS")
                     I
                                           L
                    JUDICIAL AC HUMS [
                               3-
rice on
IKtIOHl

NOTICE OF
WARNING
^

ADVERTISING! [TERMINATION
tETTER IIESTAH, REG.
,"1 T
ACTION TAKEN
ON APPLICATOR
CERTIFICATION
I
IlllCAllsl
_ .3

STOP SALE
USE OK
REMOVAL
OROER
	 I

CIVIL ADM.
PENAITJES

l-
~i

llfllUMC.ih
u,
^
/
r
nzuKfJ
J

                                                                                                             CRIMINAL
REMEDIAL
             ACT
ON
                                     COMPIAlNT
                                                                      I U.S.  ATTOHMEy
                        UEPT. OF
                        JUSf1CI
                      ( DEFAULT)
  NO
ACTION
DEFAULT
 ORDER
                                                                                             NO ACTION]
                                                                    |ALJ HEARING]         |u.s.  i>isT. _'coyijH~-t| NOT GUiLry |
                                                       	^
                                                       CONSENT
                                                       «.iaiMj.iN
                                                         T
                                                   INITIAL
                                                   DECISION
                                              FINAL
                                              OROER
                                             PENALTY^-
                                         NOT   I
                                       | (JUILTy f
             | UPHELD K—
 APPEAL TO
ADMINISTRATOR
                                                                                U.S.  COUNT
                                                                                 OF  APPEAL
                                                                | UPIIELD
NOT GUILTY
                         U.S. bUI'REMF
                             COURT
                                                                                               Ir.nij.TY junrjoT  |
                                                                                              jNJUNCTION/Sll/IIKFj
»Deterrolnations of compl lance/noncanpllance are depondiMil  upon  receipt of all  documentation and completion of  all
 Sdniple analyses.   Action preparation Is dependent upon resolution of any new policy Issues  |»f usiMih'd hy the i .<'-<•
 thi> time frames are based on the Ideal  situation.

-------
s nisi
                                                         •  j
                       hu  i
ENFORCEMENT  ACTIONS TJISIII TING FHOM cnANr INSPECTIONS
               FYlll   AHiOtlPLlSIIMENTS
                HI fit Oil     National

ENFORCEMENT
ACCOMPLI SI tMENTS
i
Inspections
i
Civil Actions
Criminal Actions
Administrative
Hear Inns
License/Cert 1 1 Icate
Suspension '
License/Certificate
Revocation
License/Cert Mica to
Conditioning or
Modification
Number of Cases
Is&ued Warnings
Stop-^Sale, Seizure,
Quarantine or Embaryo
Cases ForMariled to
EPA for Action
Other Enforcement
Actions ,
Total Number of
Actionable Inspections
Percent of Inspections
Resulting In Action
Percent of total
Actions IB7I2)
Ntimbqr of Cases
Assessed Fines
AGfllCU
Use
2,923
19
2
16
1
14
a
366
24
	 M
0

15.4
5.2
12
TURAL
Misuse
3.675
70
47
76
33
126
17
366
17
	 22
43
• aaa B acaa
BI7
22.2
9.4
•3K tf xani
59
imNAGRICIIlURAI
11*0
4.631
7
20
21
II
10
24
694
62
4
25
B7B
IB. 9
10. 1
9
Mis,,.,,
It00/
IdH
II
,-,.,
li
(i
2
412
21
~J:
4|».U
9.7
i xir iisr
INSP
.MM
20
0
0
P
0
0
	 16
3
3
0
42
I (I. ,9
14

PRODUCE
ESVAU
2,653
30
5
25
0
3
2
402
77
119
""" H7
750
20.3
6.6
•3H
MARKET-
PLACE
12,522
142
1
57
3
0
3
620
1032
163
970
2991
23.9
34.4
IM-
PORTS
523
6
0
2
0
0
0
1
0
0
10
19
3.6
0.2
CERTIFIED
APPLICR
RECORDS
11,1/5
159
90
67
502
'24

70(

7
2
1561
13.9
17. 9
116 1 I*] ^
RES1RJCIID
IISI PI SI
DIAILRS
9,1)11
44
0
14
2
1
0
219
•>u
0
9
VI /
-1.0
. ... . '**
101 Al
50,104
665
242
343
565
IB6
i
57
3002
J30I
354
1197
JI/J2
|/: 4
Kit)
424

-------
                                    1AIUE  U
               ENFORCEMENT ACTIONS RESULTING I HUM GRANT  INSPECTIONS
                              FV02  ACCOMPl I SI IIII MIS
                                        IIAI IdllAI
NiroitctHENT
ACCOMPLISHMENTS
Inspection!
4
Civil Actions
Criminal Actions
Administrative
M jar ings
license/Certificate
Suspension
License/Certificate
Evocation
License/Certificate
Conditioning or
tidhlcatlon
Viiqilifr of bases
Is sued Warnings
Stop-Sale, Seizure,
[fuarantlne or Embargo
r.ases Forwarded to
r.PA for Action
Hticr Enforcement
\ctlons
AGRICULTURAL
lisa
4,641
22
2
20

1
n
l?3
in
9
51
Hisbse
2,401
26
15
59
29
5
13
471
12
10
17
liOMATtt
Use
4,962
20
41
43
7
in
3
666
30
10
173
CUTURAL
-- •ri'i^^~" 	 "-
Misuse
1,792
27
152
175
21
35
3
406
54
5
52
I W ITSL
INSP
313






1

3(1

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-------
FEDERAL PESTICIDE COMPLIANCE  INSPECTIONS

Produce^ Establishment
Inspect! ons
Use Investigations
Marketplace Inspections
Import Inspections
Dealer Inspection's
Laboratory Audits/
Inspections
r V7 o
443
482
1115
332
359
17
"V3C
234
559
320
494
956
8
r v a •
257
435
291
241
945
4
r / - ?
2So
41 4
233
306
719
13
"Y53 _
i 51
124
210
301
0
25
TOTALS                     2803     2621    2254      2021       321
2nc Quarter FY3.3

-------
riDESAL  ?;S"i:i3£  ENFORCEMENT ACTIONS


                           r v 7 3     •rvSO    ~ Y 3'

Civil Conotaints
  Initiated                 252      175     151
CP-; ml na 1 ^e^srra 1 5
   Ini ti atec

Stop Sale, Use, Removal
Initiates                   2*3
Orders
Notices of Warning
Import Detentions
TOTALS
479 2J
507
91
1332
113
831
70
1194
105
429
71
755
50
855
53
1137
42
1270
11
1 545
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.

-------
i
S     UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
*
f                 WASHINGTON, D.C. 20460
                                                    OFFICE OF
                                            PESTICIDES AND TOXIC SUBSTANCES
                             JAN 151985


MEMORANDUM

SUBJECT:  Final GLP Compliance Strategy

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

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, in 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 Williams     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 Bell
Jim McCormick

-------
   Strategy for the Enforcement of the Good Laboratory Practice
                 Regulations Under TSCA and FIFRA
Overview

     On November 29, 1983, the Environmental  Protection Agency
(EPA)  published final  rules establishing Good Laboratory Prac-
tice (6LP) 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, environmental  effects, and chemical
fate testing under TSCA assd 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 rrgulated by EPA.  By their terms the rules
apply  to studies rel ited 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).

-------
                               -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 £R 53946, November 29, 1983) and 40 CFR
Part 792 (48 FR 53922, November 29, 1983).  Generally, the rules
contain provisTons relating to:

          (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 iised  .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.

-------
                               -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
in a previous submission.


     (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,

-------
                               -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 charactsri r.tics 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,  or
derivation of the test and control substances and must determin^

-------
                               -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
evaluati on 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)

-------
                               -6-

Enforcement


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   t
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

-------
                               -7-

that are subject to the 6LP 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 facility.

     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-oM 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 dur*ng 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.

-------
                               -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.

-------
                               -9-


Administrative Consideration?

     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 and audit.

     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.

-------
                       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,

-------
                               -2-

and Rodenticide 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  will  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 the testing
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  reque?.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 datss 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 sncjld not be disclosed except on a need-to-know
basis.

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                                    -b-
     EPA will  identify  for NTP those inspections where assistant
is  requested  from.NTP and provide NTP with a clear definition b
i
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.   Reporting  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 ality - 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.  Training Schedules - CMS will  consult with NTP on tne
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 30, 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  fun^s 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
       0-ohn  A. Moore, DVM
    TITLE:  Assistant Administrator
             for Pesticides and
             Toxic Substances
    DATE:
?-:>*-£/
APPROVED AND  ACCEPTED FOK '
T.HE NATIONAL  TOXICOLOGY
PROGRAM
BY:
   David P.  Ral1, MD, Ph.D
TITLE:   Director
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 cooperatively to assure an  effective laboratory



inspection 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 LDIP 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, ac 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 inspection.
     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
                 t
Sponsors to EPA Froduct 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.  Office 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 roonsor 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  LOIP.   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 tracks 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:
             (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  are  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  rule  or
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  (6LP)  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

JohnMV.  Moore,  D.V.M.
Assistant Administrator
for Pesticides
and Toxic Substances
                     Date
                                                O
Don R.
Office
ftfr
       Clay, Direc
       of Toxic Substances
Date
Edwin L. Johnson, Director
Office of Pesticide Programs
                       Date
                                           go
A. E. ConroyII, Director
Compliance Monitoring Staff
Office of Pesticides 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

-------
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

-------
Volume 3
                             Table of Contents
               Volume 3: F1FRA 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

-------
Volume 3
                             Table of Contents
               Volume 3:  FIFRA Compliance Monitoring Strategies (continued)
                                                                                   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
111
                              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 Suspension Order Enforcement Strategy


Dinoseb

Compliance Strategy for the Emergency Suspension of Dinoseb

Amendment to the Compliance Strategy for the Emergency Suspension of Dinoseb

OCM Memorandum:  Dinoseb

OCM Memorandum:  FIFRA Section 18 for Dinoseb

OCM Memorandum:  Dinoseb Stipulated Order

Compliance Monitoring Strategy for Final Cancellation of Dinoseb

Compliance Monitoring Strategy of the June 9, 1988 Dionseb Cancellation Order
for the  1989 Growing Season


EBDC

Compliance Strategy for the Cancellation and Registration Amendments for Pesticide
Products Containing Ethylene Bisdithiocarbamate (EBDC)
                                     11/07/79
                                     10/07/86

                                     04/02/87

                                     04/17/87

                                     03/14/88

                                     03/28/88

                                     06/15/88

                                     03/03/89
                                     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)
                       TITLE
EDB
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.S-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: FIFRA 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 1980
              Pesticides & Toxic Substances
                   Enforcement Division
                   Office of Enforcement
           U.  3.  Environmental Protection Agency
                  Washington,  D. C.   20460

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STRATEGY OVERVIEW --- - --- --- -- -------- I
BACKGROUND ----------------------- 2
?.I:--;LATSD INDUSTRY — - • --- - ------------ 3
APPLICATION OP FIPRA ------------------ 4
   Requirements of FIPRA
   PIPRA Enforcement Authorities

REMEDIES- -----------------------'6
   General
   Misbranding Purifier Claims
   Ineffective Water Purifiers
   Recall
   Other Violations of PIPRA
   Criminal Citations
COMPLIANCE MONITORING - --- ----- - ------- 9
   Program Development Overview
   Guidelines for Selection of Devices To Be Tested
   Inspection
   Post Inspection
   Testing
   Pesticide Enforcement Management System (PEMS)
   Outreach

CASE DEVELOPMENT ------------- ------- U

ALLOCATION OP RESPONSIBILITIES ------------ ,-15

ENFORCEMENT PACTS AND STRATEGY- --- - --- --- --19

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Strate£v_0verview
     Water purifiers are products which are intended to render
      ^ter sa'fe to drink by removing pests (microorganisms) through
       chemical or physical means.  Water purification devices
        e 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 PIPRA, regulation of them falls entirely
on the Office of Enforcement, which must determine if they comply
with the other requirements of the Pederal 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 jtestiog program_will examine_the purifier _claiai used by
many products.  If a product cTalms to be"""a puri'fleTr b'ut""it'd'bes   "
not remove test organisms in the efficacy test, the product  is
deemed to be misbranded and subject to enforcement action under
PIPRA, 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 G-iardia lamblia.   To
substantiate a purifier claim, a product must pass both phases.
:h"«=, 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
products 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  may  be used
 in  hoses which  obtain water from  wells,  by backpackers  to treat laked
 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 say 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 PIPRA, these
 products are regulated by  the Environmental Protection  Agency.
 There are two kinds  of water purifiers:   Those vhich  employ a  chemical
 means to purify  water, and those  which use a  physical method.  While
 both types  are  subject to  the provisions of FIPRA,  including but  not
 limited'to, Sections 1, 8, and 12 as well as  Section  2(p) and  (q),~
_or.ly purifiers  utilizing a chemical  must obtain  product registration
 a3""pre"scribel""by""Sec*t'itfS ^ ~o£ "the Act.	Under- Section- 25-fev-{4-)--o-£-	
 ?I??.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 51065, 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-and misbrand-
 ing provisions  of  PIPRA 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  PIPRA 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 .--a re found to be  "false or misleading," the
 product is  misbranded as defined  in  PIPRA Section 2(q)  and subject
 to  enforcement  action.

      The 3PA cannot  require the manufacturer  to  substantiate the
 claims made for  the  product,  so to evaluate the  performance of such
 devices, SPA 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
 mis", sad ing  claims.

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      Water  purification device producers are generally  snail
 businesses,  although  a fev large companies are also  in  the narket.
 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 night kill a micro-
 organism ia  employed  in at least one product.  The most  popular are
 ultraviolet (UV)  light, nicropore 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
-far- u-s-e.  i.r. .-small. aom.mani±ie.3_.-_^£Ji3.C3-.l,..ly...^e..Y^.,r.al, ,tajps_..and_...a_.distjrj.-
 cution network  are  part of the system.  "Small systems"  treatment"	
 units are  also  regulated under FI7RA 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 ?IFHA.
                                -3-

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   Application or r i.- .-*.A	.	
       «

        FI7HA and its implementing regulations clearly apply to devices1
   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—-*h-e- ai>pli-eabl-s se-cti-on&--i-nc-Iu4e- bu-t--are-no.t,,..l-iait^ed-ixi.4-2-(-Ti)-.,
   and (q), lt  8*and 12 of FIFRA (see-40 CFR 152.10 and 41 Federal
   Register 51065, November 19, 1976).  Based on these sections, the
   water purification devices are subject to the following requirements.
        e —.
         Establishment Registration (Section 7)
           -Registration of all producer establishments; establishment  .
               registration number on all products
           -Annual reporting of products

        "Books and Records (Section 8)
           -Must keep records of brand name of device
           -Must keep records of production data
           -Must keep records of distribution
           -Must allow an authorized Inspector to examine
               these records

        "Product must be properly labeled (Section 2 (p); 40 C?R 152.10)
           -Must bear the Establishment Registration Number
           -Must include warning and caution statements
           -Must not be an imitation of other products

        "Product must not be migbranded (Section 2(q)).  A product
           may be misbranded if its label:
           -Lacks adequate directions for use
           -Lacks adequate warning or caution statements
           -Bears a statement which is false or misleading in any
               particular
           -Bears a false or misleading statement concerning the
               effectiveness of a product
           -Bears a statement which directly or indirectly implies that
               device is recommended or endorsed by any agency of the
               Federal Government

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     For greater detail,  consult 41  Fede. ^1 Register 5*065,
"ovenber 19,  1976.   All requirements of device producers described
in that document apply to producers  of water purification devices.
    %

FIFRA Enforcement Authorities

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

     "Failure to register the establishment [Section 12(a)(2)(X)]
     "Failure to keep books and records or to permit inspection cf
        books and records [Section 12 (a)(2)(B)]
     ••lisbranding [Section 12 (a)(l)(F)]
     "Failure to file production reports [Section 12 (a)(O(N)]
                               -o-

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-e-eiies	.    	

"er.eral

     FIFRA provides several remedies for violations of-.its provi-
sions.  If the purifier efficacy claims are  found to b£ 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
Orders, 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.

Xisbranding 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
comes 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. 5. Cor.roy's Memorandum of September 12, 1930, "Interim
  .nal 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 3 -
Products in this
Phase II.  Since
well as bacteria,
     _ _ _ _    ^  »  .
                 category passed Phase I but failed
                 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
             would "bring the product" ~lffto-*<*'ottsTia;TRre-"vl-t-h---tire--ATrlr.---^/-
             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" 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. lamblia 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 ?I??.A

       •As described in the section on the Application of FIFRA,
   the Agency has authority to take enforcement action when
   provisions of FIFRA are violate!.  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 may 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.
- -  G-r i ~ i-na-1— -G-i-t a-t i on-3	
        Willful violations of FIPRA may justify the filing of
   criminal charges against a manufacturer.  PTSED concurrence
   would be required for criminal actions.
                                  -3-

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 G.v=n below  are  procedures for the compliance monitoring aspects of the
 az with description  of responsibilities ani data flow


 T-ui ielir.es for Selection of Devices To Be Tested
 '  CM3-PT3ZD will select the devices to be tested and determine the
   order of testing based on criteria noted below.

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

 "  Two categories will be established to helti determine the  order
	 of-
   -  The  first  category, which will be given the highest
      priority,  will contain those products for vhich
      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 of  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.

 *  CMS-PISS)  will prepare the sample request forms and forward
   them to the aocrotriate  Region for collection.
 Inspection

 0  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 manufacturer that
       his/her  product  is not being singled out for attention.
       The  collection of his/her device  is part of a nationwide
       effort to  test water  purification devices.
                                  —9—

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        Inspection cf books and 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 official 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-f liter,  which
           is required for the quality of water the  laboratory
           will be using should also be collected.   Specific
           guidance will be provided on the sample request
           form.

        -  Because many of these devices are very expensive, the .
       	-ins.pe ctor... should-make., an... .afcfc.ej^t_:lLPJ^iJS.3il®.. .^.nufactur e r		
           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 3700.

        If the manufacturer requests to install the  device himself,
        arrangements with the testing laboratory should be made
        through CT'2-PTSED.

        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 advertising or contacting a
           local trade association, then a marketplace sample
           can be obtained.
     £/   Barlow's Decision:  Guidance to Re.^ional Personnel:   Conduct
:f Inspections after the Barlow's Decision {April 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 and records inspection nay be
           obtained.  This will be necessary if production
           and distribution data is needed.
III. PCS* Inspection
T
        When the requested.sample has been collected,  the "PRD
        Acknowledgment" copy of the sample request form will "be
        forwarded to CM5-PTSED with the "Sample Identification"
        section completed.

        All non-confidential information obtained by the inspector
        will be placed in the enforcement jacket and forwarded
        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 CT-I3-PTSED for contract
           management purposes.
        Efficacy testing will be performed by the State of New York,
        Department of Health, Division of Laboratories and Research.

        Each device will be examined when received by the laboratory
        for any possible defects resulting from shipment.

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

        The device will be subjected to a series of niicrobial challenges
        until it fails or e:
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        CMB-PTSID  is  to be kept  informed  of  the  testing status of the device.
        This information is to include:

        -  sate the official sample was received

        -  date testing was initiated and completed

        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 wiH go directly to the appropriate
           Region  from the testing laboratory for review to determine
           violations, and to initiate enforcement action.

        -  A copy  of  the test results will be forwarded to CMB-PTSED
           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 Znfcrcemer.t ".anagement System
     The Regions will keep ?TS3)  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 PE-S Computer system.
V +. .
     Oatreach
     y.any manufacturers of water purification devices do not appear to be
aware of Section 7 establishment registration requirements.  To help notify
industry of these requirements, a  letter  to potential manufacturers and
their trade associations has been  prepared (Appendix I !
     The responses from 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
oublic and notifying industry of  the establishment registration requirements
(Appendix
     As a result of this cutresch  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 OE-PTSID,  Comp" lance Monitoring
Coordinator.
                                       -12-

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      Microbiological  data generated  "by this program 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.
      The results  of  this program are also of interest to the National
 Sanitation Foundation  and D-19,  Conaittee on Water Microbiology of the
 American Society  for Testing Materials.   It is possible that presentations
 will be nade  to these  groups.

      Regions  may  release information concerning individual cases in the saae
     er that such  information is  handled  in other civil proceedings.

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  \
  "7
           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 cerermir.es 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
                              test results &
                           enforcement jacket
i
           test results
                                       -13-a-

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      Case  development will proceed  in accordance with  the  Case
-eroceedi«ng3  Manual.   The Regions  are  advised  to avail  themselves
  f  the  option of Enforcement Review through  headcuarters.   The
 ^.abel review will be  done by the  Registration Division using
 the  product  performance criteria  developed for evaluating  both
 chemical and physical water purifiers and the data  on  product
 performance  from the  efficacy test.
     Please note that a civil complaint should be issued along with
  e Stop Sale, Use or Removal Order when the product fails the
efficacy tests.
th
                               -11-

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                          •^r»«f7TP-** ^1T PT^CD^'"?TTxTT TmT'"">O
  ^	jVwrll lLg< Of ^L^io. ^.iC'^Jil/ill^O	

  • is chart is a eraiie to the responsibilities for the different tasks in the water
   iiication device enforcement rrogram.
                                                                  Regions
     Identification of Purifier Devices

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

     *  Regions submit info mat ion on
        ne*f products they becone aware
        of to Compliance Monitoring
        Branch
2.   Selection of Devices to be Tested

     *  Compliance Monitoring Branch
        updates list of known devices
        and selects devices.

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

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

                                                      *  Regions assign inspectors to
                                                         conduct establishment 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 FIFRA procedures
                                                         and guidance;  special instruc-
                                                         tions may appear on the sample
                                                         request form.
                                      -15-

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            Headquarters (FTSZD)
                                                             Region
                                                          Inspector ships saaple(s) and
                                                          one set  of documentary
                                                          to  testing laboratory, ser
                                                          copy of  documentary  sample
                                                          headquarters,,
 5.    Testing of Devices

      *   Laboratory (Environmental Health
         Center, State of New York, Depart-
         ment of Health, Albany,  N.Y.j*
         performs efficacy test according
         to ITS 3) approved protocol;  furnishes
         results etc.  to PTSED and'the
... 	•—-S-egisn-.--(See-S.3.- —below.) The ..lab 	
         will keep the device until litigation
         is completed.
 6,
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 well
   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 Enforcement Review.
   The reviewers compare testing
   results a^iinst 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 testin.g 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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           HeairjLarters (PT5ZD)
            Regions
                                                         Based on the laboratory's
                                                         determination, the Regions
                                                         may initiate action on the
                                                         purifier claim.  This should
                                                         not preclude discussion of
                                                         the case With headquarters.
7.  Determination of Appropriate
           ment Response
    *  If misb rand ing violation based on
       the purifier claim has occurred,
       headquarters may provide additional
       info neat ion based on historical files.
       .i-rrr-rccri-ate-. records and. recommendations ._ ......
       vill be forwarded to the Regions.  If
       advertising is seriously misleading, a
       referral to the Federal Trade Commission
       will also be made.
Determination of Appropriate
Enforcement Response

0  A Stop Sale, Use or Removal
   Order (SSURO) will be issued
   for all products which fail
   efficacy test.  A civil penalty
   is. ..£lsp._as3es_s_ed..._	
   Region applies general PIFRA
   civil penalty policy and
   matrix to determine appropria-"'
   level of actions for all .
   violations.
     Enforcement Actions, Litigation,
     Settlement

     0  PTS2D may, under exceptional
        circumstances, initiate
        enforcement actions.

     *  Sections of the agreensnts
        which involve label or product
        improvements to bring the product
        into compliance are to be sent to
        PT3ZD for concurrence.
Enforcement Actions. Litigation,
Settlement

0  Regions will initiate
   enforcement actions
   (warning letters, civil
   complaints, SSUROfs).

8  Region may obtain expert
   testimony from headquarters
   reviewers or laboratory
   scientists.
     Completed Case Files

     e  PTS3D will maintain a file
        of all test data results and
        copies of Final Orders for use
        in docu.-T.3nting the possible need
        for regulatory or legislative
        changes.
Completed Case Files

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

9  A copy of the Final Order
   should be sent to  PISS).
                                      -17-

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           Eeaisuarters (FTSZD)
                 Regions
10.  Publicitr
        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.

        Consumer Information determined as
       _a.-r.9sult.. .afL.the_whQle_.prQsr.gm.»
        - nuriber distributed
        - type of use/risk factor
        - conclusion to be drawn from the
          program.
10.  Publicity
        Release of information
        individual cases in the
        manner as' other pesticide civil
        cases.
                                       -18-

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Er.foreegent Facts and Strategy
       %

—jueniix I:   Types of Purifier Products                       20
Sppendix II:  Legal Definitions,  "Purifier" and "Device"      22

Appendix III: Publicity and Outreach                           >3
                                        -19-

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                                                                   Appendix I

                   TY"°JES CP PURIFIER PRODUCTS
      *               -- —   ' •   '  • '

     Water purification devices employ a variety of techniques to purify water.
The most common techniques are:

     e  Ultraviolet light - Light of wavelengths around 260nm damage's the DMA
        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 role-
        exiles.  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 sazg types of products used
        to develop the protocol is useful to the U.S. and Canadian Enforcement
        Programs.

     *  3ubmicron 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 30:22 bacteria  •
        are capable of changing shape.  The filter would consequently not work.

        Ultrasound. - High frequency sound causes pulse waves to for: 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 macrmolecules and cellular organelles.
        Whether it would be efficent on the scale necessary to purify water is un-
        known.

     8  Chlorine generators -  These devices electrolyse salt (NaCl) to fora chlorine.
        The chlorine acts 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
        fcr his own use and not for sale or distribution.  Unfortunately, since there
        has been virtually no regulation of these products, the label directions ma\-
        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 ionised to form ozone, a
        powerful oxidizing agent 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 rssulted in lower levels of ozone production.
        Installation is complex - often done by the seller - and cheaper products
        -ay be unsafe electrically.

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

        Distillers -  These products condense stesm from boiled water.

                                      -20-

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

        P.everge Osr.ogis -  High quality organic polymer membranes
        selectively filter water. This product is si.-nilar 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
        oolecular sieve.  Complex organic molecules are prevented fron *
        crossing over to the "pure water" side of the membrane. Virases,
        bacteria and protozoans would also be  retained on the "impure
        side".  Maintenance of these products  is important.  A damaged
        membrane would not purify water.  There is some 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:

     *  Potable vater "rurifers" - These products use the term purifier on
        their labeling cut are clearly intended for use on water that
        is already potable (i.e., faucet "purifiers" for use on municipally
        treated water). Mamfacturers 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.

        Large purifiers which treat water for  groups of twenty-five persons_
        or more.  These products are regulated by ?I?HA.  However, the quality
        of the water is requlatei by the Safe  Drinking Water Act.  Since
        the public is protected by another act and the resources of the Office
        of 2nforce!sent are limited, these products will not be included in this
        program.  (These are also known as "small systems" purifiers.)
                                      -21-

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                                                             Appendix II
                   Legal Definitions. "Purifier" and "Device


     Sines the enforcement strategy and penalty plicy 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).
              eli n'es ' 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-?36
          (1973) pg. 6~i

3.    Devices

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

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••~- •'«•>•-»  ••-•••   ' ^  '.  - i ww j
fren  Tpj^.o-^T^
I (CM /l63w«««*Ci.».j./
                                          IN THE'MATTER OF •

                           -'SIB CO PRODUCTS COMPANY^ IKC., ET. AL.

                   ORDEB, OPINION. ETC., IN BECABD TO THE ALLEGED VIOLATION OF
                   '                , FEDEEAL TSLVDE COMMISSION ACT         "
                        ,
                   .Orde/ requiring a* New Jersey manufacturer' 6f" water YjJtraton to  ceas*
                              "tla* the «tfectiver.eM ar.d  capability o/ its water CJtrsnoa
                               deceptively guanwtcaiag the perfonnanca or such, unita. .
                                                                           • iS17
                 - ^2.  ImplieU ., Represer.is.iian3'- -Respecting "^ic
                 •Viruses
                 • Complaint counsel charges that by the use of such words as '"pure/*
                 "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 .si*.
                 Jeged 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  remove 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.  We 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. Giant FoodSj
                 Inc. v. F.T.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' prospecti%-e customers  actually received  thi? pam-
                 phlet. Furthermore, this discl.-.irr.er was not inserted  until respond-
                 ents' precoraplaint negotiations with complaint counsel. Finally, the
                 presence of  this disclaimer '•.  ;-.o of reiponcicnLs' brochures does
                 not negate the contrary irr.:'   -:. :n in the r.frirmativc representa-
                 tions  contained  in their au\ i   . .— or.ts  and  sales literature  as to
                 the purifying qualities of  tlulr  unit.

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i--r-"'^  :--cr, jrirt  cr iusoart (j:  Guidelines  for Recistrar-fcn -of Pesticides •;•
7*3  Ur,';:as Staias:  rrccuct  Perron  ir.cs Stancards  (pg4  145-145).  (Full  text''
     lable frr.r, headquarters.)              ''f            '   -   '          .;.
                                                     . >
                                                     /
           elements: representative levels of organic-and inorganic soil

           contaaination; various water teaperaturas; the specific dosage
                       * •  '
           and exposure period  recocsended for the proposed product; a

           variety of  test nicroorganisss representative of the target pests
                                                              //
           to be controlled; and quantitative determination of the level of

           aicrcbial contaainacion of the vater before and after treatment.

            (ii)  Performance  standard.  The treatment taust eliainate all

           test cicroorganiscs  frca the water.

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

           intended for the treacaent of rav water to elininate the potential

          ' health hazard posed  by oicroorganisss is identified as a water

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

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

           to achieve  the intended purpose of purifying aicrobiologically non-

           potable vater by eliminating watar-bome pathogens in the vater

           itself.  Those units, such as subaicron se=branas and absolute filters,
                                                         •
           which rely  solely on a physical reans for resoval. of sicroorgsnisas

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

           to regulation but not registration.  The test requireaents indicated

           below are for the units containing an antimicrobial agent.

            (A)  Test standard.  Controlled si=ulated-use studies for the

           water purifier ur.ir  nusc be conducted under conditions representing

           actual use  employing a defined raw water source containing a high

           level of aicrabialogical pollution.  The test design wil  vary
                                        145

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vith different  types of units and patterns of use, but oust include


euch basic eleaenta as: representative levels of organic aiyi in-
              * •

organic soil contamination; various water tesperacures; doctaen-


tation of the antimicrobial concentration found in Che test system;


and quantitative detemiaations of Che oicrobial contamination


level of the vater  before and after passage through Che unit.  The


duration of effectiveness or effective capacity of Che unit before


a replacement is necessary oust be doct=aenced»


  (B)  Performance  standard.  The treatment oust eliminate the


cicrobial pollution in the rav vater.


  (ii)  Potable vater'treatment unit.  Any unit intended for ?hys7


ical and/or chemical treatment of aicrobiologically potable vater


froa a municipal treatment facility to remove undesirable tastes


odors, chemicals, or other aesthetically objectionable properties


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


as activated charcoal (vlch or without a bacteriostatic agent) is


incorporated into Che unit for this terminal processing treatment
                                                   *

of potable vater prior Co consumption.  Since the requirements of


Che Safe Drinking Vater Ast do peraie ausicipally-treated drinking


vater Co contain a  linitad number of harmless "saprophytic" bacteria


vhich are cozaonly  recognised contaainants of vater, an antiaicrobial


agent is scaetises  incorporated in a potable vater treatment unit


to provide bacteriostatic activity against these contaninants.  Only


potable vater treatment units containing a bacteriostatic agent are


urder the purview of "he Act.

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"•xerpt fror. In re  Contact Industries. Inc.  (pg. 6-8).  (Full  text of  document
Available from headquarters.)       "
                      ENVIRO.T.r.HTAL 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 mutter.   We are in agreement with the conclusion of
      Complainant's expert witness that the "word purifier is sufficiY^U'
      broad to include ridding the air of ob.icctionables, includinq mirrn-
      orgsnisnu as they would exist."  An air purifier would therefore
      cleanse the air of air-borne bacteria, 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

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                          .   - 7 -

taken together with the word "Sanicidc" on the label would indicate
that tlvj proJjct is intended to rid the air of germs, that is,
bacteria or virusss.
     "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 v;ords
on that side of the label.  It is clear that the word "Sanicide" is
meant to provide the rr.ost conspicuous reference to the product.
     "Scinicide" implies both 3 sanitizing and a killing action or, at
the least, a killing action.  Sanitize rceans to free from dirt, geras,
etc., as by cleaning or sterilizing.-  The suffix -cide means killer
or killing.  Se« lobster's Third Mew International Dictionary  (19(55).
A consumer would, we believe, recognize the meaning of the suffix.
-cide as is evidenced by the corr.;7ion usage of words such as homicide,
pesticide, and insecticide.
     In interpreting broad remedial legislation, the consumer  is not
assumed to be 
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                               - u -

rc?.d.  UnitLu States v. Article.1*, of Drug.  Etc., 263 F.Supp.  212  (D.
Mcb. 1CC.7).  Cf. Hclhros l-/.?.trh Company v.  Federal Trade Cc:mir.sicn.
310 F.2d 8GS, , 859  (D.C. Cir. 1952), cert, denied 372 t>.S.  976
                                                          «
(1952), rehearing denied 374 U.S. S57 (1963),  and cases 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 -cida 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
act.   (See section lC2.2(ff) of.the regulations  (40.Cm lCL.3(ff))J.
The claim  that  the product  Superior Sanicide Air  Purifier  is an air
purifier \/hun 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
                                       I/
162.3(ff)(2)(i)(B) (Er.iphasis supplied).     Thus,  representations ir.acie
      ]/  iM,icroorgr'.:ii:::i]3,  inr.li'dinp but not limited to algae, fungi,
and IncLcria,  and  viruses have been declared by the Administrator to
be pc!3ts '..-I'.en  ti;oy o;:iit  under circumstances that MU!;C thevi doletiirious
to man or  tho  cnvircivnc-nt (Sec 40 CFR I62.l<1,(b}(4) and (5)).

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        UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                      WASHINGTON. D.C. 20450
                         JM   8198!
                                                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 C1v1l 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, Director
                            Pesticides and Toxi^/Substances
                                 Enforcement Division
Attachments

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                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
     Violations
     Inspection Scheme
     Violation  Detection Priorities

ADMINISTRATIVE CONSIDERATIONS

     Program Management and Allocation of Responsibilities
     Program Integration

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  _La.!e_9.y_ f o r t h e Enf o r_c_e m e n_t o f_ the Ch i 1 d__R_e_s_1 s_t a n t
 a c k a g i n g"Rje g uTa't i o n "I) n dTr' HTRA~

Overvi ew
    On March 9, 1979, the Environmental Protection Agency
published a final  rule at 44 £ede_raj 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 is 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 fo presidential use.  (2)  it Jn a s  n o t
keen 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
 ecords, 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 PTSED 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 In packaging and certify that the packaging
complies with the CRP regulation.

    For your information certain terms used in the Strategy have
been defined below:
    o
       "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.


        "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   "Toxiclty criteria"  are  defined  in  44  Federal  Register
        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.

    0   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 jestricting  the  sale, use, and
        s t. n r a a e  t o se rv iceoersons ._

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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 .nrosecutori a 1 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.

        Am end 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

-------
                       -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 6162.16(d).  An applicant for
a new registration shall  also submit a certification
statement that the package meets the standards.

UtJLIIze special packaging

Products subject to the requirement must be In child
resistant packaging 1f released for shipment  after
March 9, 1981 .

Recordkeeoind

Certain records must be retained by the applicant or
registrant for as long as the registration 1s 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
         (8)  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 , relled
                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 to assure compliance with this regulation
so as to minimize or eliminate accidental exposures to highly
poisonous pesticides used in and around residential areas.
Outreach
    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.

Viol at ions

        Mjsbranding - §12(a)(l)(E) of FIFRA
            As defined in §2(q)(l)(B) of FIFRA, a pesticide is
        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 §25(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
              uti 1 ized) .

         (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 Rpgin'rpd - §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 PTSEO so that a request for the data can  be  sent  to
        the company's headquarters by OPP.

                      of Application/Report or of Records
        laintainedHar 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
        illegal.

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 following table 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
poli cy.

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
 cri ten" a.

 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-
Kle  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 tus or
requests.
the v a 1 i d 1 t ." of t h
M 11  r r> v i o w i n <)
Program Integration

    The Case Development and Legal Branch, PTSED, 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
  MEMORANDUM
                                                                     OFFICE OF
                                                            PESTICIDES AND TOXIC SUBSTANCES
  SUBJECT:  Enforcement Strategy Concerning  CViild-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.

fv  1.  Disinfectants

   Product             Concentration
   1.   Calcium
       hypochlorite
   2.
   3.
Lithium
hyprochlorite

Sodium dichloro
s- triazine trione
and Trichloro-s
triazine trione
                    65%
                            35%
                            98-100%
   5.

   6.

   1.

   8,

   9,
Mono (Trichloro
tetra (monopotassium
dichloro) penta-s-
triazinetrione      99%

Hydrochloric acid   8%

Phosphroric acid    17%

Chlorophenolics     6%

Sulfamic Acid       20%

Quaternary Ammonium
Compounds	    105
   10.   Parafomaldehyde      95%

   11.   Formaldehyde         37%
                                        Use
swimming pool
Swimming pool

Toilet bowl

n       n


Disinfectant

Toilet bowl


General disinfectant

-------
2.   Ips^c^pide and Rpdepticide

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


10.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 .
              and
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, (Jfiief/y
Disinfectants Brarich
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

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                                                                nr; .; <• ^
                                                            •  V ' " "


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



Q 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 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  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 (EPA Form 8570-11).


     2)  Five copies of draft labeling  incorporating required changes.

-------
                                - 2 -

     3) If necessary, a Statement of Confidential  Fornula  (EPA Form
        8570-4).
  «

     Registrants must normally submit applications within  60

calendar days of receipt of the LIP Notice.  The Agenqj 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)(D) may  not be combined with
     /
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 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.

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                                - 4 -
Typesof Violations
     Producers not complying with the requirements  of .the notices
                                                      m
issued under the Label Improvement Program are in violation  of
of FIFRA section 12(a)(l)(E) 1n 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) 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) Termi ti 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) Antifoulinq Paints - 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 Ernes is  - Issued 11-30-80 - This LIP Notice
  T
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 and the 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.

-------
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 Ernesis.

     2) Registrants with the most number of products with accepted
        amended labels subject to any LIP Notices in the following
        order: -Fumigants, Te~rm1 ti~cTd~e~sy "Anti fouTi rrg Paints and
        Salt Water Emesi 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.


Inspecti ons	


     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 Responsibility	

a) Provide Regions  with a  compliance strategy for Label
   Improvement Program,
                                                            V  V
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
Overview
     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  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.

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                                - 2 -
     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 with 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 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.

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                                - 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) 1n 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) 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) Termi ti 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) Antifoulinq Paints - Issued 3-9-82 - This LIP Notice required
registrants of all antifouling paints to make extensive revision
of their product's labeling.

-------
     4) Sal t 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 and the 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.

-------
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: Funn'gants, 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, Te~rm1 ti~c~fde"sv "Anti f ouTi n~g Paints and
        Salt Water Etnesi 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.

Inspect!ons	

     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

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                                -  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 Responsibility	

a) Provide Regions  with a  compliance strategy for Label
   Improvement Program,
                                                            .  s.
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
   in compliance.


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.

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              UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                          WASHINGTON, D.C. 20460
                              SEP 3  1985
                                                            OFFICE OF
                                                    PESTICIDES AND TOXIC SUBSTANCE;

MEMORANDUM
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-
     ° 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 NOTTS 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  31965
        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.

-------
                                -2-

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

     0  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.)

     0  Allows a registrant and other parties  adversely affected by
        the NOTTS to request a hearing within  thirty days of
        receipt of the NOITS 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 FIFRA
§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
          all the information which the Region has received from
          SSURO may only be vacated by OCM.   This  will  only be
          OPP is lifting the suspension because the  company has
          compliance with the data call-in request.   The  Regions
copies of
OCM.  The
done when
come into
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-
Is working with OPP to develop and implement a system for tracking
suspensions and SSURO's.

Regions	
Regions forward information on the suspensions and SSURO's to
the 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.
Regi ons
SSURO's

States
wi11  hand!e any
issued by OCM.
cases arising from violations of the
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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       i     UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

      f    '             WASHINGTON, D.C. 20*60
                                                         OFFICE OF
                                                  PESTICIDES AND TOXIC SUBSTANCt
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
                                                            Printed on Recyd;-J Paper

-------
                  ADDRESSEES
           l'    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)
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
I    Marvin Rosenstein, Chief
     Air, Pest. & Toxics Mangt. Div.
     Pest. & Toxic Substances Br.

II   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                                                   ;
                                                                       t
COMMENT 3                                                              J
                                                                       t-
One commenter asked what would be the appropriate enforcement          -
action if the inspectors discovered pesticides on the                  .-
cancellation list in the marketplace.                                  r

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.

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Cancellation Information

COMMENT 4

One commenter 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             t
nonpayment of the registration maintenance fees.  OCM will send        c
out periodic updates amending the list of products cancelled for       }
nonpayment of the fees.  In addition, in April, the Compliance         j
Division of OCM published a booklet, "Suspended, Cancelled, and        -
Restricted Pesticides", which summarizes the Agency's actions on       [
such pesticides.                                                       *
                                                                       c
                                                                        I
                                                                       L
                                                                       J.
                                                                        I
                                                                        C
                                                                        cr.
                                                                        ;*
                                                                       r
                                                                       o
                                                                       fD

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                        SUMMARY
      COMPLIANCE MONITORING STRATEGY FOR PESTICIDE
  REGISTRATION CANCELLATIONS DUE  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 shbw 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

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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.
REOUTREMENTS
     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.                                                            ?

Exports _       |j
                                                                        SB
     In the case of exports, any products exported after the            >
effective date of cancellation must comply with section 17 of           g
FIFRA, which includes citations for other applicable FIFRA              5
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          SJ
say in a conspicuous manner "Not Registered for Use in the United       E|
States of America") .                                                    ^
COMPLIANCE MONITORING
                                                                         N;
                                                                         CO
     Compliance inspections are to be conducted by the States and        *"
EPA (in States without Cooperative Enforcement Agreements) during        £
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,  OCM, 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	

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  I
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.
#47319
#11275



#01457


#08730
Registrant &
Product No.

Savanah Co.
047319-00001
047319-00002
047319-00004

Guth Corp.
011275-00002
Hexcel Corp.
001457-00015

Hercon Environ-
mental Co.
008730-00035
Product Name
                           Sevana Bird Repellent
                           Sevana Bird Repellent
                           Agrigard Insect Repellent
  Lithate 2,4 D - Broadleaf Weed Killer
  Non-Volatile
  Bromat
                           Lure N Kill Roach and Ant Killer
                           Insecticidal Baits With Sex Lure

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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 &
USER LEVEL
10-18-89
  3-89
                 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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             N I rE D -- ." '-,  -.:-.••<  - 1 .
                                    APR 30 1990

MEMORANDUM

SUBJECT:  Strategy for Aldicarb
'. ~^ ->?
~;X!'J SUBSTANCEb
FROM:     John J. Neylan III, Director
          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
0
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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Irw.in 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 VIIT

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 pn label:
EPA Registration No.     Brand Name
264-319                  Temik Brand TSX Granular Aldicarb
                           Pesticide (1)
264-417                  Teiiiik 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
      (THURSDAY, 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.

     E?/k will continue to review and r.onitor this  situation and t.ike i:.y
 further action if necessary.


*.»••".  '•         •
                it - Ji
                IT T TT

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...  .  . I  V
•j Vv/y ?    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
> v • •l ""* -t
 N ••i,.yAc>'                     WASHINGTON. D.C.  20460

                                             JAN 1 o 1975
   To:        Regionjil—^Administrators

   From:    AssTStatvi Auivumstrator* forvVater
             and Hazardous. Materials (WH-556)

             Assistant Administrator for Enforcemen//
             and General Counsel (EG-329)

   Subject:  Continuing State Registration of Products Containing
             Aldrin and Dieldrin for Which Uses Have Been Suspended

       Late in December, 1974, the Agency became av/arc of the existence of
   activity in the  above referenced  matter, first in the State of California,
   and subsequently in several other States in other Regionsa  Preliminary
   investigation into  the magnitude  of the problem suggests .that there may
   be significant continuing activity on a national scale,  that there is con-
   fusion as to the extent of Federal jurisdiction  over such activity by States,
   and that the  economic,  political  and regulatory considerations involved
   require additional  action by the Agency0

       Accordingly, our joint staffs  are preparing a Federal Register notice,
   v/hich,  upon publication, v/ill formally assert FedT.ral~3urisclicUon over
   non.-Fc:C;0!'aUy registered  products containing Atarin and  Dieldrin by
   iiiiplL'iv.cntinrj Section 3. of the Federal Insecticide; Fungicide  s.ucl
   Rcdenticide  Act (FIFRA), as amended (7 U.S. C.  'l36 et seo.).  Attached
   is a strategy paper v/hich explains the background of this matter in greater
   detail and provides an explanation of how those Aldrin and Dieldrin pro-
   •ducts should be  treated upon the  activation of Section  3.  In addition,
   proposed enforcement activities by 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 the
   proposed substance  of  the  notice as outlined  above and in the attached
   paper to  inform affected States  in your Region of these developments.
   Further, \vetrustyou \vili encourage their support and cooperation in our
   effort to achieve orderly and equitable  disposition of existing State-reg-
   istered products together \vith even-handsd and  comprehensive enforce-
   ment of the  Aldrin-Dieldrin cancellation  and  suspension orders.  The
   Enforcement Division o: each region \vill be contacted by the Pesticides
   Enforcement Division in Washington v/hich v:ill provide additional do tails
   and support, \vhcre needed, to achieve Federal-State cooperation, in pro-
   viding notice of these developments and in proceeding- \vith  enforcement
   of the Administrator's orders relating  to cancellation and  suspension of
   Aldrin and Dieldrin,

   Enclosure:

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 l;    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

«o"-°"                      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 IX
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 Dicldrin
must bear the label restriction: "For use only in  formulating products
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 provid-2 de facto Federal control of all products containing
Aldrin or Dieldrine Investigations by California  and Region IX (confirmed
now by several other Regions  and State.-;) have revealed that many. State-
re£istp;-ed AlciirLn-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-Dicldrin products bearing State or Federal
registrations  and lacking any stated restrictions concerning refor-
mulation, 3) formulated from technical mete rial sold after December 2,
1972 which failed to bear the required restriction,  4) formulated from
technical material restrict!vely labeled and ignored by the forrnulator.
States, having lately become aware,  of the intent of the Decemner,  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 juric'Uc-
tion over their production,  shipment,  sale,  and  use, and to insure -jven-
handod enforcement of the Aldrin and Dieldrin cancellation and suspt^pion
orders,  ihe Agency will formally implement Section 3 of the Federal Insec-
ticide, Fun'gicide,  and Rodcnlicide Act,  as amcndod (7 U.S. C8 13G ct scq.)
by notice in the Federal Register. Tiiis 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 for  orderly disposition through shipment, sale and
use in that  State, existing stocks of products containing Aldrin 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
productSo 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 must cease to register for shipment, sale and use
any but existing stocks of such products,,

    Regional offices should  arrange  to advise appropriate authorities in
State a 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.
Stales are  to be asked to  provide to the appropriate Regional Offices lists
of State registrants or persons v.'ith registration applications pending for
products containing Aldrin or Dioldrin. Information relating to location
and relative amounts of these State-registered products also is to be
sought.
   •to-
    The Agency's pesticides enforcenicnt personnel vrill enlist State coope-
ration in  continuing  its on-goir.c;  investigation of the  formulation since
December 7, 1972, o: products containing Aldrin or Dieldrin for State
re^istralion.  Should it be the case th::t Federal registrants of technical
Aldrin or DieJdi'in have not r^ir.bole^ their products in coni'ormancc \vitii
the Administrator's  Order of December  7,  1072,  or that pesticide pro-
ducers have formulated products containing Aldrin or Dieldrin in con-
travention of labeling prohibitions against xise in non-Fcderally registered
products,  such viclr.ticns vail be prosecuted in accordance v.ith the appro-
priate provisions of the Act,

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      «J"ITED STATES ENVIRONMENTAL PROTECTION AGENCY
                      WASHINGTON. D.C.  20460
To:      [Enforcement Division Directors]

From:   A. E.  Conroy II, Director         //  '£  C'7*-"-^/^' -~ ~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 -Federally 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<2r 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-Federally 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  stce^tion that numerous products containing Aldrin and Dieldrin
r-'.a*' have be--n produced since December 7. 1972 and rpaistpreH v>y SroT^s
under circumstances not strictly contravening the December,  1972 Order.
Details concerning this production and questions relating *o the scone of
Federal jurisdiction over such production under the December, 1972
Ord^** a»*e 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 Aldrin or Dieldrin in  s:\is -
            tence on the date of the signature by the Administrsc^ v of
            the order activating Section  3. After that date, all ^rod'-.c-
            tion of products containing Aldrin or Dieldrin  must cj-se,

-------
                                -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 -proof ing 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
            obtainin  for Federal use:

            -  lists of State registrants or persons with applications
               pending for Aldrin-Dieldrin product registration;
            -  information on location anrf relative amount? OT" such. f|
               ducts within the State;

            -  assistance of State enforcement authority to achieve com-
               pliance with the prodxiction, 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 StatvD 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 contain-
            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.

    Shovld you have questions or encounter difficulty  with regarn 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 follo\v-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^te-of-the-Ord-er-wili-be-p-rohibited-.- Accordingly^—the-5trtc-xrf-frram-e)—
can register or continue registrations only of non-Federally registered
Aldrin-Dieldrin products \vhich 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 F1FRA
   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)(2)(G)
         Action:    Civil /Criminal /Stop Use

3.  Sale of a non-Federall}' registered Aldrin - Dieldrin product pro-
   duced after the effective  dale of the Order,  but before violations
   are actionable  (60 clays after publication in the Federal Register).
         Action:    Stop Salv

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

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           UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                        WASHINGTON, DC 20460
                        JUN  6 1989                        OFncEOF
                                                         PESTICIDES AND
                                                         TOXIC SUBSTANCES
MEMORANDUM

SUBJECT:  Compliance Strategy for the Cance I I at Ion ^f  Non-wp
          Uses of the  Inorganic Arsenlcal's                  ""
                                        \ I       I J  //   — *^
FROM:     John J. Neylan  III, Director   W   \  A/J>l/*s~/^-
          Pollcy and Grants Division     rV/\^ )f^
          Office of Compliance MonltorlngJ   (\ *£/

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 trloxlde  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 herblcldal 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(c)(2)(B) .

     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.  Inspections  of dealers  and users
will be conducted to ensure that cancelled products are  no
longer being sold or used.  Tips and complaints are to be
Investigated as received.

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

[I   Barbara Metzger, Director
     Environmental  Services Division

I  I I   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 4 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

            Alvin 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)

-------
        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  arsenlcals 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 funglcidal 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 arsenicals 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.

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                             -2-


Existing 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 cancel led products are no longer being sold
or used.  Tips and complaints are to be investigated as
receIved .

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
trioxlde, 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	

Will develop and transmit the Compliance Monitoring Strategy to
the Regions.

-------
                             -3-
Will  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
schedu I e .

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.

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                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

    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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          UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                      WASHINGTON. D.C. 20460
                           JUL   6
                                                        OFFICE or
                                                 P6STICIDCS AND TOXIC SUBSTA
MEMORANDUM

SUBJECT:
FROM
TO:
Compliance Strategy for the Conditional Registration
and" Cancell ation of Certairf\IJromoWnil.xPirbl3ucts
                            \\\ x \\ ^
John J. Neylan III, Director
Policy and Grants Division
Office .of Compl iance Mo ni tori

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

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                                 ADDRESSEES
     Douglas D. Campt
     Edwin F. Tlnsworth
     Anne Lindsay
     Frederick F. Stlehl
     Mark Greenwood
     A. E. Conroy I I
     Connie Musgrove
     Mike Wood
     Jerry Stubbs
     Sherry Sterl ing
     David DulI
     Ken Kanagal ingarn
     Bob Zisa
     John J. 'Neylan  III
     PhylI is E. Flaherty
     Maureen Lydon
                     (H7501C)
                     (H7505C)
                     (H7505C)
                     (LE-134A)
                     (LE-132A)
                     (EN-342)
                       ti
                       it
                       it
                       it .
                       it
                       it
                       ii
                       it
                       it
                       it
     Jake Mackenzie
     Western Regional Compliance Director
VI


VI I


VI I I


IX


X
Louis F. GItto., Director
Air Management Division

Barbara Metzge'r, Director '
Environmental Services Division

Stephen R. Wassersug, Director
Hazardous Waste Management DIv

Winston A. Smith, Director
Air, Pest. 4 Toxics Mangt. Div

William H. Sanders III, Director
Environmental Services Division

WII Iiam B. Hathaway, Director
Air, Pesticides 4 Toxic Division.

William  A. Sprat I in, Director
Air and Toxics Division

Irwln L. Dlcksteln, Director
Air and Toxics Division

David P. Howekamp,  Director
AiP Management Division

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

Ernest Regna, Chief
Pesticides 4 Toxic Substances Br

Larry MI 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
Pesticides 4 Toxic Substances Br

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 Tlce           (TS-769C)
     Al Heier            (A-107)

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    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                  .
   LEV
by 8/7/89



by 9/6/89*




by 9/6/89*
between 10/1/89
and 11/1/89
between 10/1/89
and Spring,  1990
growing season
          Restickering of  products released for shipment         Registr
          after 5/5/89;  Stickers sent to dealers for             Produce
          relabeling by 5/15/89.

          Restickering of  dealer stocks  carried out by          Distrib
          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.       Registrc
          Plan must be implemented prior to 1990 Spring          User
          growing season.                             •       '   Interfac
  2.
Voluntary Cancellation of  Bromoxynil  Butyrate  Products**
TARGET DATE FOR
INSPECTION
          ACTIVITY TO BE MONITORED BY INSPECTION,
          PER TARGET DATE
LEVEL
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

Distribut

User
     As part of routine inspections.

     Includes  the following products:  Dragonmate, ME 4 Brominal, Torch Twin Pak,  3+3
     Brominal, Bromoxym'l 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 conduct 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 OF 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 Stickerina/Labelina	
      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 1,  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 nave
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 compliance with the conditional
Registration* Agreement and the Cancellation 'Order.  This will be
accomplished through registrant; producer establishment, and
marketplace inspections.  Enforcement actions regarding the
Cancellation Order will be taJcen, 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

-------
                                     -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 l,  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.

-------
                                    -5-           .   .

User Level	

     Within 60 days of the date of this strategy, inspectors
will assure, during routine scheduled inspections, that non-
cancelled bromoxyni.i 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	

Office of Pesticide Programs	

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 this
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.

-------
                                    -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.

States	;	

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 noncdmpliance with
the Agreement ,• they should-investigate to ensure compliance.

-------
                                            APPENDIX

                 BROMOXYNIL 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
Buctril + Atrazine*      264-477

ME 4 Brominal
(Buctril ME 4)**         264-340
(Also produced as
3+3 Brominal
and Torch Twin Pack)
                                            Estab. No.

                                            264-OR-001



                                            264-OR-001

                                            264-IA-001
Estab. Address

Rhone-Poulenc AG Company
6200 NW 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

-------
                                              -2-
Oragonuate Broad!eaf     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.  S4.  N'o.  Ill  / Monday. June  12.  1989 / Notices
                                                                                                                           24949
    Name ol applicani
                             Lccauon
                                                                                     Reviewing agency
                                                                                                          Rnel
                                                                                                                       ; Dale of fcnal
                                                                                                                          action
Long tttnd Lighting Co.
                       ! Weat Babylon. NY.
Nassau Cittnct Energy Corp..) Unondala. NY —
Kamne Carma^e Cogenera- : Caflnaga. NY—
  lion Co.. Inc.           I
Momli Press Co...	i Fuftan, NY	
Kamir.e Sou*  Glens  Fjia  Sot,m Glens FaJs.
  CogeneraMn Co.. Inc.    :   NV.
inaert-verttes energy Sarv- • Tjnawanda. MY-.	
  cea. Inc.
Soise Cascade Corp	i 3eevet ?*•», NY...
        LJ BccT.e Ire	' Barvidera, NJ
                                          Construction of • 220 MW gaa turbine
                                            tatty.
                                          Cortructton ol a 57 MW coganeraton facility	
                                          Construction ol a SO MW yu turoine.'sieant ganer-
                                            itor.
                                          Construction ol an 11 nation rotogravure press and
                                            muurfication of an 8 tlauun rotogravure press. '
                                                                                     NYSCeC.
HCfCLf»s Inc	; PafT.. MJ ..-	—

Long Island bgntmg Co	 Snorertam, NY._	

Life Seven. IPC	:	! Las Piedras. P3	


Aooort Laboratories	_... Barceioneta, PH....

Mecan-Paome. Associles. ' Carson. NY	
  Inc.                  :
United Development Group-  Niagara Fatis, NY...
  Niagara, inc.
Town o« Norm Kempstead  Port V/asr-ngton.
  Solid  Waste Management]   NY.
  Authonry.              V.
L&J Er.enjv Systems. Inc	 howviK, NY	
Fennsajken   Solid  W3«e  PerVsr-Aei. NJ..
  Maragament Autrorrty «.  j     \
                                        ',  Connection at a 50 NW gas tureme>«team gener-
                                        !   «:or.
                                        ,  Construction of a 53 MW jas turome.'steam gener •
                                        •   »;or.
                                          Rer, taccrrent of an  exisdng oiUired boiler won  a
                                        .   new on-fired ooiler.

                                          Revision of tne nitrogen oxide emisaon limit pavi-
                                           pusly  permitted tor  a  23.3 MW cogeneraticn
                                            vstem.
                                        !  Rev\on of we  panicunjaa manar amiaaien torn
                                                  r permitted tar three coaMved oaierm.
                                          Corttritaon o< a 220 MW gas turbine generation
                                        ;   factrty}
                                        '  Cor>«vuco»P  of a new steam boiler and a new
                                        I   gvnerator\arMW cogenerarcn facility.
                                        ,  Construction of «y9 MW gaa turome/steam gener
                                           ator.
                                        •  Construction of a coaJ fired coganeration system	1

                                        I  Construction of a 990 V» per day municipal wast*
                                          . resourcaa recovery I

                                        '  Construction of a 49 MW |
                                        i   ator.
                                        !  Construction  of two 250
                                           5-M waste iiioi.eiaicfs.
                                                                                     NYS06C	


                                                                                    XPA region II....
                                                                                     EPA>egion II
                                                                                     NYSCECs.... ............... I  PSD permit
                                                                 i tuit»na/steam genar-

                                                                    per day  municval
                                                                                    NYSCEC	
                                                                                    NYSOEC	_	
                                                                                    NYSOEC	
                                                                                                      PSOparmft
                                                                                                        ..do—
                                                                                                        ..do	
                                                                                                       .....do—
                                                                                     NYSCEC	_JO._

                                                                                                 	!	.dot..
                                                                                     NYSOEC.
                                                                                                      PSOnorv
                                                                                                        appkcabHity
                                                                                                        determination.
                                                                                                      PSD permt reviw
                                                                                                     I
                                                                                     EPA region>.	1 PSO non-

                                                                                     EPA region II .

                                                                                     NYSCEC	

                                                                                     NYSDEC	

                                                                                     NYSDEC	
                                                                                     NYSCEC	

                                                                                     NJDEP	-
                                                                                                        applicability
                                                                                                        determination.
                                                                                                       PSO parmt rexroton

                                                                                                       PSOperrm*
                                                                                                      \ approval.
                                                                                                       \..do	
                                                                                                                        i
 7/t8/88

10/07/88
10/19/88

<2/OS/Sfl

12/05/88

 1/09/89

 t/11/99


 1/17/89


 1 /17; 89

 1/23/89

 3.01/89


 3/06/89

 3/06.89

 3/10/39

 3/15/89


 3/20/89

 4/20/89
    1 On May '8. '9ae. tne Ls"g
Z20 Wegawan ?MW1 gas tuo ne c
us Nove-noer 25. 1988 FE;=
                                 Lqmnc; Comoar.y (LILCO) *33 issued a PSD
                                 aop tari'^y 'Of :•* We« 8ao>;on plant Tne
                             ^:-.sT^R nance on s-n PSD acrry«s_ because
                                                                          by the New York State Department of Environmental Conservation tor a
                                                                            not considered elective and tnereiore waa not inchxMon EPA Ffeqon
              .	   	   _  	    	   _	   __  ,   _  . wara received during !ne pubkc comment penooVltowevcr. a*
'ssues were resoweo during an njjim aprterence" ht-:a O NYSOcC. Furtn«Tiore. mikcomrnerrs »d not  result «i any change m me May ta. \988 permiL
Tiere'c'e  LILCO s PSD 3«rm.! tcr :*« vvesfajayicn c'ant n considerec ertecave as of Julv f8, 1988.                                         \
   : T-.e Pennsaukan $.ya wai'.^) Minacs-fier^ A.thon'y if-S'AMA) was issued a °SU perrr«t\)n Feoruary 10. 1989 by tne New Jersey Oeoanrxent ol env»onmer!al
Protecticn  Tr-Ts ?.vmt *o'iid ^ave beccnv e*lec!:ve on  Mjrcn 13. 1939 if no petition for adn                  ...  .   .^ .
C-C. Kwever.  a petnoo for i
                    for review «n$ ;-t<>c t?»V>e Towr imp of Cinnarrmson. tne 9orougn o«
1989. :ne EPA Aommstrator oqoceT  a-.ei cjre^l review ol lf« appeal not to grant furtr.^r tavn:.
oMpnl 20. 196J.
                                                                               	   ..   ..  .           ley I
                                                                              move review waa filed with tne EPA Aomimsiraior r
                                                                                rra, and the BCKOugn of Rrverton on Marcn 7. 1989. On ,
                                                                                i ^c petroon. Tnerefor*. trie PSWMS PSO permit 3 effect
   This notice lists only the sources that
have received finai PSD dete^ninations.
Anyone who wishes to review these
detcrrrVmaiions and related materials
should Tcntact tt.s following offices:

EPA Actions
I'nitod S!at>}s. Envirortr.entai Protection
   Agency. V- .-g(on il Cifice. Permits
   AjininistntiC
                 i Branch—Roc.-r. 505. 26
                       Yoik. New York
NYSDEC Actions
New York Slato Department of
  EnvTonmtntal Ccrseryation. Division
  Of Air Resources. sourc\Rev:5w and
  Revvonid Support SectionVsn Wolf
 . Road. All-jny. New York r^33-(XXn.

NjDEP Actions
.'•'ei% [nrsey I^.-pwr;ment of
  Environrr.i ntal Protection. D.\ .ii\n of
  Environmer.ai QiM'ity. O-.ireju of
  F:r.;.-:nt!eriP.c: A Technoli.cy 401 E.-s
                                             jtate Street Trenton. New Jersey
                                              H625.
                                                ^available pursuant to the
                                             Consolidated Permit Regulations (40
                                             CFR PVt 124). j'ldicial review of these
                                             c'.etermiHations under section 307(b)(l)
                                             of the Cle\n Air Act ;ihe Act) 3»ay be
                                             souaht or.lysby the r.iing of 3 petition for
                                             review in thad.'nited States Court cf
                                             Appeals for tnkappropriute circuit
                                             within 60 days item the date on which
                                             these determinatHjns are published in
                                             the Federal Hegistefc. Under section
                                             307(b)(2) of the Act. Jtjpe
                                             determinations shall nM  be subject to
                                             Liter judicial review in c\v:l or criminal
                                             proceedings for c

                                               Dated: June 1. 1969.

                                             \Yiliiam J. Mmxynskj,
                                             \'.~R Doc. 90-1.1849 Filed 6-9-38: 8 4S .m]
                                             B:LLIKC C=CE
                                                                                         IOPP-6613S; FRL-3600-4]

                                                                                         Order Canceling Registration for
                                                                                         Pesticide Products Containing
                                                                                         Bromoxynil Butyrate
                                                                                         AGENCY: En\irjrunental Protection
                                                                                         Agency (EPA).
                                                                                         ACTION: Cancellation notice and order.

                                                                                         SUMMARY: This notice announces EPA'a
                                                                                         decision to cancel all registrations
                                                                                         irsued under the Federal Insecticide.
                                                                                         Fungicide, and Rodenticide Act (F1FRA)
                                                                                         for pesticide products containing the
                                                                                         butyric acid ester of bromoxynil (3.3-
                                                                                         cJibromo-t-hydroxybenzoniLriie). The
                                                                                         r^gistrint Rhone-Poulenc AC Company
                                                                                         has requested voluntary cancellation of
                                                                                         these products. Because of the
                                                                                         developmental  risks associated wiih
                                                                                         exposure to these products. EPA will not
                                                                                         permit and  the  cancellation order will
                                                                                         explicitly prohibit the sale, distribution.
                                                                                         a ad use  of existing stocks of affectt J
                                                                                         products.

-------
24'J.IO
Register
.'i.'.. It i
Mor.i.'.tv. L:r.t:  ij.  l^W.)
DATE: The cancellation order
incorporated in this notice will become
effective June 13. 1989.
FOR FURTHER INFORMATION CONTACT:
luJi: Anureasen. Special Review/
  Registration Division (H7j08C).
  Office of Pesticide Programs.
  f-:.:-.inr.mental Protection Accncy, 4U1
  M Street SW.. Washington. DC 20400
Office location and telephone number:
  F.-. lOOtjF. CM =1 1021 Jeffprson
  n.ivis fiigh'.VH.v.  Arlington. VA. (70.1)
  jjr-liro.
SUPPLEMENTARY INFORMATION:
I. Request for Voluntary Cancellation
  On Mjy  1. 1989.  as a result of
ciiscussfon  between EPA and Rhone-
P'jLiijnc AC Company concerning
measures to minimize potential risk of
developmental toxicity associated with
exposure to bromoxynil. Rhone-Poulenc
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
Rhone-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 bromoxynil. EPA considered
it inappropriate to issue an existing
stocks order for such products.
n. Existing Stock*
  In its May 1.1989 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
          bi;tyr;ite would present an unaccept,:Ho
          r;sk of development*! toxicity in pi-rsnns
          handlira such products. Accordingly.
          EPA will not pprrr.it the continued s.iie.
          distribution or tnp of any canceled
          prodi!<:t cnnta:rin« h'orr.oxyni! hi.tyra'^.
          EPA encourages all pers^.T.s holdir.g
          storks of c.-injdt.'d p.-oducls cont.i::::ns
          bromoxynii hutvrute to participate in the
          recovery prog-am est.-.hiishcd b> Rhone-
          FVjler.c.
          HI. Cancellation Order
            Effective June 13. :0fi9. the
          reaistraiior.s for all pesticide  products
          containing the butyric acid ester cf
          bromoxynil (3.5-Jibromo-4-
          hydroxybenzonitrile) 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)(2)(K). 7 U.S.C. 136j(a)(l)(A).
          l36j(al(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    i . Previous
           registration I registration  !      Product
             No.    I    NO.     !
             264-339 :	'  Oragonmate.
             264-340 |	  ME 4 Brcmuial.
             264-340 !	  Torcri Twin Pad.
             264-340 i	j  3-r3 arominal
             264-394 i	:  BromoyrH Butyraie
                    I          [   Technical
             264.421 	Certrot
             264.474     3£3-7!6  Euctnl 4 EC.
            This Order does 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-Poulenc
           AC Company, or which are otherwise
           necessary to facilitate proper storage or
           disposal of such products.
            Dated: June 5. 1989.
           OouglM D. Campt.
           Director. Office of Pesticide Programs.
           [FR Doc. 89-13648 Filed 6-9-89: 8:45 arr.J
           •tUJNO COM
               =RAL MARITIME COMMISSION

           Agracmfcqtfs) Filed
             The FederaKMaritime Commission
           hereby gives nome of the Tiling of the
           following agreements)  pursuant to
           section 5 of the Shippirt^Act of 1984.
             Interested parties may ih*oect and
           obtain a copy of each agreement at the
           Washington. DC Office of the Fafcral
           Maritime Commission. 1100 L Str
                             ,NW.. K..OCI KV,:? .'.-.vr.-stcJ f
                               ay submit cor.rv.f.-r.ts on r.T".
                                     ;: to the S. . .-I-.:...!".. f-Y.,
                             M\r::imr? Cornrr.iis.ur: W.'>'-..r.
                             205TJ. within 10 days after the .:
                             the rk'derul Register :n wr.ii h :h
                             appeAfs. The requir>!rTit'r-.!s for
                                          four.J in  § ?"_.<•>.
                             4f> of th\ Code of Fe-ic-ral K. -
                                       per<
                                      /ore (

                             agreement."
                                 ..Tfp-.-e/.'VVi;..- 202-OKIG-6
                                                 . r.S.A. Frn
                             Cu-nforence ("6ur.ferrr.jo").

                               Achille Lauro
                               Compania Tras^:!ant:ca Espj.-.
                                 S.A.
                               Costa Container L\ne (a Divisi.
                                 Contship Containerlines Lirr
                               d'Amico Societa di .\av;gaz:on
                                 S.P.A.           \
                               Evergreen Marine Corporation
                                 (Tai-.van) Ltd.
                               Farrell Lines. Inc.
                               "Italia" di N'avigazione S.^.A.
                               Jogolinija
                               Jugooceanija
                               Lykes Lines (Lykes Bros. Stekm
                                 Co.. Ltd.)                  \
                               A.P. Mcller-Maersk Line      \
                               Nedlloyd Lines (Nedlloyd Lijr.cr
                               Sea-Land Service. Inc.
                               P 4 O Containers (TFL). Ltd.
                                Zim Israel Navigation Co-npany
                                \nopsis:Tbe proposed modific
                             would permit any member to
                             disassociate itself from any Confe;
                             actionYn a rate or service item the
                             would rasult in a reduction in the c
                             cost per cargo unit to the shipper b
                             giving written notice to the other
                             members prior to the time the rate
                             service item lias been filed with th<
                             FMC and beciyne effective.
                               Agreement No.: 217-010738-003.
                               Title: Barber Blue Sea/Open dull
                             Carriers Chartering Agreement.
                               Parties:
                               Wilheimsen UnesVv/S
                               Open Bulk CarriersVLimited
                               Synopsis: The proposed modifica
                             would authorize the parVies to disci.
                             and agree upon rates, charges and c
                             competitive matters regarding
                             intermodal movements. It would als
                             permit the parties to agree upon sail
                             schedules, service frequency.\nd p<
                             to be served by each party. It would
                             further make other non-substant\ve
                             administrative changes.
                               Agreement No.: 232-011184-002.A
                               Title: Evergreen Marine Corpora ti*
                             (Taiwan) Ltd. Italia di Navigazionc '

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            UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                        WASHINGTON. D.C. 20460
                                                          OFFICE OF
  -- -    •   •                                     ' Fesncioes AND TOXIC suasr/

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.,
                                  r
                                  Robert "jT:  Taylor
                                  Product Manager (25.)
                                  Fungicide-Herbicide Branch
                                  Registration Division (H7505C1

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DATEi    />V/  /  /?/_?_  TIME-'   I/' c«**\   TOTAL NO, OF  PAGES
                                            (INCLUDING  COVER PAC-E)
 TDi     eau.sJ    7/vsc/j-t/v _   LOCATION:

 FAX  NO i        7'J-  .rs-? -3/*6 _   SENDER'
PLEASE ADVISE BY  FACSIMILE OR PHONE IF MESSAGE IS NOT LEGIBLE OR ALL  PAGES
ARE NOT RECEIVED.


FACSIMILE NO, ISi  919-^9-9619
                                                        "*.

DIRECT LINE TO TELECOMMUNICATION.S OPERATOR  IS«


                                     M£SSAfi£
    TO:  Edwin Tinsworth
        EPA
   . Attached 1s the  AopJicatlon for Amended Registration  of bromoxynll products.
r"*4 'It should contain all  the revisions discussed.  A copy is also being sent overnight
    mail.  If there are any  questions, please let me know.
    Sincerely,

    Nick Somrna
'513A

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 RHONE-POULENC
RHC-NE-POUUENC AO COMPANY

                                                          May  1.  1989
     Robert  Taylor
     Environmental  Protection  Agency
     Office of Pesticide  Programs
     Crystal  Mall,  Building  2
     Arlington,  Virginia    22202
     Dear Mr.  Taylor:
           SUBJECT   Ductril  (264-437),  Bronatc  (264-438)
                       Buctril  * Atrazine  (264-477)

           Rh6ne-Poulenc  Ag  Company  hereby applies to  conditionally
     amend pursuant to PIFRA §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  Poulenc
     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 Poulenc
     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
AC6CABCM TAiAfcGLC P*«"<. M C 97TM
(»18) M9 2000
INTERNATIONAL TELEX NUM86O 4099371 ANSWCB8AC* APC RTP
INTERNATIONAL OlSTWBJtiON SC«VlCCC TClC* MJMOCH 4899377-ASSWHOBACK APC IOC

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                    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)instructions
                    '(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 Jeqiiipment needs

11.User  Training
     A.Training of users
          1.prior  to 1990  spring use
          2.pending EPA  approval
     B.Hard-coupling 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 AO 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.   Rhone 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 additional  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 wili
     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
Ae6CABCMTaiAN3.EMBir.NC 27700
        :. TELEX NUMBtn «*»37i»- ANtw%u*Ac* APC DTP
               tO». 3£flVlC« TClCX NJMQCB «9W3"- AUCWCP34CK APC IDS

-------
 ff  RHONE-POULENC
s	^S=====

     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.   Rhonc-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.   Rhone 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 Uiis 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 lo the  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
     PO BO* IJOM. }" w AL£«*N?€» PO've
     •fSfABCMlRIANv. *•»*(«. NC 'J/>Vi
     (019)349-333:
     INTEONA'iONA- TC.EXNuweEA 4W33'i-AN«w{aaM> AOC W»
     INT£«N*T
-------
(f( RH&NE-POULENC
      RH6NE-POULENC AQ COMPANY

           Pilot:
                Submit  Protocol-May  8,  1989
                EPA Approval of Protocol by--May  23,  1989
                Study  Initiation-May  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  Initiation-November 1, 1989
                Study  Completed-March  1,  1990   •
                Final  Report -May  1. 1990
          Male Reproduction Effects  Study

          Pilot-
                Submit  Protocol -June IS, 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  Completed— February  1,  1990
                Final  report -June  I,  1990
                  Exposure  Study
          Submit  Protocol-June 15.  1989
      PO (OX 12014 JT W ALf «ANfWa fMIVC
      AESEAACx TftANClE M4K NC 97700
     INTERNATIONAL ICkCk NUMKR 4M037* ANSWERBACK APC «TP
     INTMNATlOMAl O'SmiOUTlON CCHVCEC T£L£X NUMBER 40»3?7-ANSWCnO*Ct< ATC IDS

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(fP RHONE-POULENC	

      RHONE-POULENC 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 f«.r
          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 date 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 Rh6ne  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
      »O BO* iW 2 Tw AIEMKP6" CWve
      ncS:Af\£M TRIANGLE AM»< NC 27709
      (919) S«9 JOOO
          ION*t TSLB» NUM9CO 40W3TI

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 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 Rhonc-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 Tinsworth
BO iox taoM
"E6CABC* TBlANClf Ak«K. N C 37700

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                                                •  -*-'
                                                                    «r"» (T8
                    Application for Pasticicte: U Registration
                    -        	.	L&Arnendment
                                                                                                   102852
Company/Product Number

     264-477
                                         2 Daw
                                                             BtctJon
                                               May 1.  J989
                             of
                                                 3 Product Managar
                                                    Robert Taylor
4. PtopOUC O«ll «.C«
    n_
    g»n«
                                              Rhone-Poulenc Ag  Company
                                              P.  0. Box 12014.  2 T. H.  Alexander Drive
                                              Research  Triangle Park. NC  27709
               J   I Ch»e«i K mil u t
                             Buctrii  + Atrazlne Herbicide
                                                 Saetlon » . Am«ndm«nt Information
                                 l«tt«r
a
                                                      l«b«l
                                                                           0«1» of Untr

                                                                            May 1. 1989
                        Label modification  to Include  Restricted Use. Classification  and additional
                        label restrictions.
                                                            •ectlon III
                M«l».l«l ThU Product Mill 8* P«ek«a*0 In
                ^••-^ I  ^••••J—•-•• •!- - ^.^•^..^•^••^•^^•^^••^•^
               . tOCCtlon of N«t Contents Mo>m«Uon
                                         umt Packaging
                                                      No.
                                                W«wr.6otu04« Packaging"

                                                         PINO
                                                                         • walght   N» par eontalnar
                                                                             Typ« O« CenuM
    PlMtie

    0<«M
    p«p«>
                  OnUMt

                  On m>»fl«l wcompanytng product
                                                      e. Mannar m Which UMl to Aff.xad To P/oouei

                                                                          Flc»»af^
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ft HONE— FOUL. EXIC  A G   COMPA *TY



BROMOXYNIL SPECIAL LABELING COMMUNICATION PLAN
09:20:38A
May 1, 1989
COMMUNICATION
MEDIA
FAX
DIRECT MAIL
PERSONAL CONTACTS
STICKER PERSONAL
DELIVERY
DATA-LIMB
RADIO
POINT OP PURCHASE
INFORMATION
DISSEMINATED
RESTRICTIONS/
USE DIRECTIONS
RESTRICTIONS/
USE DIRECTIONS
V
RESTRICTIONS/
USE DIRECTIONS
V
PACKAGE STICKERS
RESTRICTIONS/
USB DIRECTIONS
RESTRICTIONS
(SEE DEALER POR
FURTHER INFORMATION)
RESTRICTIONS/
USB DIRECTIONS
TARGET
AUDIENCE
DISTRIBUTORS/
RPAC SALES/FD
DISTRIBUTORS
RESELLER/CUST APPLTR
UNIVERSITY EXTENSION
GROWERS (RESELLER MAIL)
UNIVERSITY EXTENSION -
WEED SCIENTISTS
RESELLERS
CONSULTANTS/FARM MGRS
DISTRIBUTORS
RESELLERS
GROWERS
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 PRANK
DAY 2
DAY 5
1
V
WEEK 3
W2BK 1
WEEK 1 - 1.500
WEEK 2 - 1,500
WEEK 2
WEEK 1-2
WEEK 2-3
WEEK 3
WEEK 3
WEEK 2-3
TOTAL NUMBER CONTACTS: 238.739

-------
                                         S:«i*t
                                                     . OC
Application for Pesticide:
                              Registration
                            .*J Amendment
                                                                                       10285:
 1 . Company/Produoi Numewr
        Z64-438
   Oat*
                                                 fioetlon
May  1, 1989
 i M»rn» «nO taO<»M Of Applicant (Y*c/w0* Z/^
3~ P*l to 0*
ffiamT
      Mick Somma
 IBT
      Registration Manager
                             Telephen* No. 0vo/v0* A*a Coe>*>>
                              919-549-2372
   1 ovrtfy that Mi* *t*«*m*nt* I hew m«d* en tfiJ*
   OOfiptot*  1 •oknowl^g* »i«t any knovingly <•)*• or
   Imp' laonment or both wnd*r ipplleaMa law.
                    aU
                               *t*f*<0 an «rw*. aaeuraia. an*
                        •utanwnt may p* puAJtfiaW* by fin* or
   ""
  Typotf Na/nf
            Nick Somna
                             3. T
                                                          Registration  Manager
                             $. Oam Stgnoa
                               May 1.  1989

-------
                                   ''*g fprm
                                        SlaKt En»ie^m*»ui Pioicdion Ag»r\ey
                                         iO* Of P»»t>e.d» Profl'tmt rrS-767)
                                            WMhinflten, OC 30*«0


                          Application for Pesticide: P Registration

                            Kr                            ULJ Amendment
                                                                        102850
 Company/Product Numoor

         264-437
            2 Oat*

             May 1 .  1989
                                               -ftftfiiifia
           Pioduot i

           Robert  Taylor
4 PropOMS C »M>i.;tt.e-

 J   ]o«n«-i« fX~|i«a*'
 Nam* «nd
of Applicant f'rtCJwO* 21P Coat)
                                Rhone-Poulenc Ag  Company
                                P. 0.  Box  12014,  2 T. W.  Alexander  Drive
                                Research Triangle Park,  NC  27709
1   | O*«fc K thli It • n»w «ddr*H
                  ^  .,  ,.  ^.  .  .
               BuctrH  Herbicide
                                    S*etlon II - Am»ndm«nt Information
 5*»b)»cl


            °
             (""I Final prinud iab«i
             I   1 In nnfianta tfi Aa«
                                             new IMMr
                                     Oatt of b*nti

                                      Mav  1. 1989
         Label  modification  to Include Restricted Use Classification and additional
         label  restrictions.                             '  -
                                               Itcilon 111
V M*l#n«l Tni* Product Will 8*
 Loetuofl of N»I Conttnts mtormaUon

I"™! Ub«i      I"™] Oonwww
                                     n
                         u-
                           UnK paofcaga *»1  No. pw eontainai
                   fl
                                                     No
                                        •as*«o« vwlght   He. p*i oontalnat
            4 8Ub*«

   \ On m«»«l«l •eoompanylng product
                          — '
                              |
dt«noil*d
                                               flooilan IV
      Nick Sonm
      Registration Managtr
                                        Talapftona Ne. (Inctud* A/»a CooV/
                                          919-549-2372
        that in* «at*m*fttt I hay* mad* on tni» form and at) attachment* tftanno am true, •oaurata. and
           aefcno^odQ* that any knowingly falaa or mlslaading Matemant may b* punishabla by «n* or
  ImpfMonmant or both und*f «pp»eabi« law	          	       	
 . TypMNWTW  /•     /" •
            Nick  Somna
                                                       3. Till*

                                                         Registration Manager
                                           May 1.  1989
                                        (Stvnprt)

-------
ATTACHMENT A

-------
                    RESTRICTED  USE  PESTICIDE
    Cor ratal Mto ts and ut* ont> by C*flfi«d Ap0cdors or p»Tcn3di«afy indt* ttvn scpkjrvoori and onty fcjr ihow os*s dto
•Bramezynll oetenocto «qu>v«l*nt to fci$% o( bromoiynll or not tea* Uwn
 2jO pound* of bromarynlt par gallon.	
                                                                                            .33.4%
                                                                                            oe.0%
                        KEEP OUT OF REACH OF CHILDREN
                                AVISO     WARNING
PRECAUTION AL U5UARIO: 9i uat*o no
                                        , no u«> •*(• pfoquclo »••» gut
                                                                           rv»y« >*3O •xpltaaoo >rnpli>rr»m*)
B.P.A. R»g. No. 264-437
                                     far PRODUCT LME I
                                                                    74».
NAIANM TO HUMAN* AMD OOMCCTIO AMHAU
WAHMMQ . •ItTNCKO UM
                                             M*
fcM teen »»i««w w MIM* Mr* «•!•«<• m l«k*>M»fr wloill*  W*n»n •!
         *|*
    <* IK*
•Mint M
                                         tai an in* eragr«m
                                     > 33* •'«»
                           MUSI OM*ivf
        no* (•• M^I) •>»*r*ll *•! ax~- *l tu                      .
•M >*r  Tiw qg»«ri% n«*i t» «am ««•• * teng M*»* ixn «n« tang pirn Wmi OBWI n*>*>
nu*
        k p«ai«gitf In • JO 9«Bn arum or « yaw n*na» • WMI
       dr
       iM»a»
                                                "*• *
                                          Th» punp a> P>«B»
AU. 'CMSONt «*nrma rnie »KOOUCT. on MI»A«INC OB CUAMINQ
uses WITH n t
                   to *M f mtr*
imionit ett or eadw*  *t«*< «pp*»<«t "*•> • w««*>'««>< «r aiUima a*,
   ntm* f laow "v»i M UBI MM* in* gift. «i< m»i tn «on vMn •ii.ing in* up n
•MlCATQN. »r CXMQATON KMI to dan* By tad Ot».
                   MM » uMA'» cturTIMKin. IN* «•• "** no) to I •><•>) In
                                                - .  .
                                                             AIMIAl APPUCAT1OM.
                                                             '
                                                                                «r 'MOMrt •• p>o
                                                                               w«tiln XX !•« •) ••>
                                                                                          p>o*t>M4 «
                                                        OCNUUi, MOvmtkBN't n»m AU UM

                                                            TANTI
                                                                ll> •*!
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-------
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                      RESTRICTED  USE  PESTICIDE
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 B UCTRIL* f Atrazine Herbicide
POSTEMERGENT  HERBICIDE  FOR CONTROL  OF  CERTAIN BROAOLEAF  WEEDS  IN CORN  AND
SORGHUM.
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-------
                     RESTRICTED  USE  PESTICIDE
    For ' «ttl M* to Aid u*» onry Oy
                                                         wnao»
                                    S«« u«CBLrti>'wy slalerneTs te
                                                                                      rUwJ US*
 B RON ATE  Herbicide
 FOR COrHTROu^r CEH T AIN
                                        L/9 i" »> "
ACTIVE INGREDIENT
    Octanote add ••w of bfe»mo«ynll' (3,5-dlbromo I hyd
                                                                                                   34.0*.
INCBT NOREOIEKTS;
                          KEEP OUT OF REACH OF CHILDREN
                                            WARNING
6PA R»fl. No.
                                                                                      EPAE01 No.
                                   POf PRODUCT USE Information Ctll
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ATTACHMINT  B

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                  BROMOXYNIL CONTAIHCR RELABELING  SCHEDULE.
FOLLOWING IS A DETAILED PLAN DESIGNED TO APPROPRIATELY RELABEL ALL BROMOXYNIL
PRODUCT CONTAINERS EXISTING WITHIN THE CHANNELS Or TRADE, INCLUDING
RHONE-POULENC, DISTRIBUTOR- AND DEALER INVENTORIES, IN A TIMLFRAMS1 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 WELL AS FUTURE PRODUCTION QUANTITIES
SCHEDULED FOR THE REMAINDER OF 1969 USE SEASON.

RPAC WILL IMMEDIATELY HALT SHIPMENT OF ALL BROMOXYNIL PRODUCTS UNTIL
APPROVED AMENDED LABELS CAN BE PRINTED AND AFFIXED TO EACH CONTAINER
WITHIN RPAC POSSESSION, IN A MANNER CONSISTENT WITH THE "RELABELING
PROCEDURES" OUTLINED IN ATTACHMENT A.
DAY 4-10 FOLLOWING EPA AMENDED REGISTRATION APPROVAL

REVISED LABELS WILL BE DELIVERED AND STICKER1NG OF RPAC INVENTORIES
AT PLANTS AND WAREHOUSES WILL BEGIN.  NEWLY L •> E H  IKIU '  W LL BE
RELEASED FOR SHIPMENT TO DISTRIBUTORS.

ADEQUATE QUANTITIES OF EACH APPROPRIATE LABEL, ACCOMPANIED WITH "RELABELING
PROCEDURES", WILL BE SHIPPED TO RPAC FIELD SALES REPRESENTATIVES FOR
IMMEDIATE DELIVERY TO DISTRIBUTOR WAREHOUSE LOCATIONS WHERE BROMOXYNIL
INVENTORIES EXIST OR WILL BE DIRECTLY MAILED TO DISTRIBUTOR LOCATIONS.
APPROPRIATE COMPENSATION FEES WILL 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
WILL BE PERFORMED TO INSURE COMPLIANCE.  DISTRIBUTORS WILL BE INFORMED
THAT NO BROMOXYNIL PRODUCTS MAY BE SHIPPED PRIOR TO RELABELLING ONCE
LABELS ARC RECEIVED.

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                BRONATEe/BUC1RIL'/BUCTRlL* * ATRAZ1NE
                   RELABELING COMPENSATION PROGRAM

 THIS PROGRAM  IS DESIGNED TO COMPENSATE THE DISTRIBUTOR AND RESELLER
 FOR RELABELING' HIS CURRENT INVENTORIES OF BRONAIE*, BUCTRIL* AND/OR
 BUCTRJL** ATRAZINE BROADLEAF HERBICIDES TO COMPLY WITH EPA REQUIREMENTS

 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 MlN-I-BULK CONTAINER.

 CURRENT PHYSICAL INVENTORY AS OF 	
                                        (DATE)

               BRONATE'*    BUCTRIL*    BUCTRIL* * ATRA71NF
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 LliTEiJ AiiOVE, AND HAVE RECEIVED ADEQUATE QUANTITIES OF REVISED
LABELS FOR RELABELING ABOVE INVENTORIES.
BUSINESS NAME:

STREET ADDRESS:
CITY: 	 COUNTY:      '       STATE: 	 ZIP
OWNER/MANAGER: 	 PHONE:
                       (SIGNATURE)
RHONE-POULENC REPRESENTATIVE:
                                    (SIGNATURE)          TtRR.lT

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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^RS WILL BE INFORMED  THAT NO BROMOXYNIL MAYBE SOLD PRIOR TO RELABELLING
ONCE cABELS 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 LA8CLS 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.

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                                ATTACHMENT  A

                  BUCTRll*, BUCTRIL* •» ATRAZINE. BRONATE«
                            RELABELING PROCEDURE
2J-GALLOII JUG

1.  DEPALLET1ZE 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 N1TR1LE 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.                                   *
                                                  o

7.  RETURN JUGS TO CARTON AND REPLACE GLOVES ON TOP OF JUGS.

8.  FOLD DOWN THE TWO SMALL FLAPS OF CARTON AND FOLLOW WITH TWO LARGE
    rLAPS.

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.
       o

30-GALLON DRW AMD 110-CALLON 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.

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ATTACHMENT  C

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 RH&NE-POULENC
«HdN£-POULENC AO COMPANY


OFFICE MSMORA NDUM


 TO:     N1ck Somma      .              DATE:    May J.  1989

 FROM:   Dave Downing


     Please find attached the Bromoxynll  Label  Amendment  Communication
 Plan.  Our goal'Is to reach all  persons  who sell, apply  or  recommend
 bromoxynll products within the agricultural community  1n 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 CPA approval.  Resellers
 w1Tl be contacted on a priority  basis  according to their past sales
 volumes as recorded by Rhdne-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 bromoxynll products  and
 to contact their local reseller  for detailed Information.

     Rhone-Poulenc feels that this communlcation plan will serve  the
 Intended need to alert the agricultural  Industry of  the  proper manner
 to handle  and apply bromoxynll products  with minimal risk during the
 1989 use season.
 DPD:vwg
 Attachment
 cc:      J.N.  Harton
         S.A.  Schmotzer

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                BROMOXYNIL LABEL AMENDMENT COMMUNICATION PLAN
UPON RECEIVING FINAL APPR'OVAL FROM THE EPA OF 1989 LABEL AMENDMENTS
FOR COMMERCIAL BROMOXYNIL OCTANOATE FORMULATIONS, ADD 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 OF 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 CACH DISTRICT AND
REGIONAL OFFICE. WITHIN RHONt-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 LABCL CHANGES AND THE PRODUCT RELABELING
PLAN HILL 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 OP 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 OP 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
 OF BUCTRlL«. OUCTRIL* + ATRAZINE  AND BRONATE* AND YO  Nf . Ut   < I < W
 TO SEEK DETAILED LABEL  AND  PRECAUTIONARY INFORMATION THROUGH THi IR AG
 CHEMICAL SUPPLIER.   APPROXIMATELY 143.000 GROWERS ARE EXPECTED TO BE
 REACHED OVER A  SEVEN DAY PERIOD WITH 30-SECOND RADIO SPOTS RUNNING TWICE
A DAY.

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                            DEALER/DlSTfUBUTOR  LETTER
 ATTCNTJO* -  LA8EL  CHANGES  FOR 8RONATE*. BUCTRIl* AND BUCTRIL» * ATRAZINE
 This  1s  to  Inform  you that  BRONATC*.  BUCTRIL*  and BUCTRIl* * Atrazlne
 broadleaf  herbicides  li»ve  recently  been reclasslfled as  "RESTRICTED USE
 PESTICIDES"   and  that  the  labels  have  been  amended  to  Include  new
 precautionary  statements, additional  protective clothing  requlrements, and
 ne* 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 wnen  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
 BUCTRIl* •*• Atrazine  are  stlckered with these changes,  a relabelling-program
 Is being implemented by  Rhfine-Poulenc 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 Rhfine-Poultnc  will   compensate  your
 efforts  at  a  rate  of SO.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 must 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
Retailer*),  please   call  the   toll  free   Rhfine-Poulence   Hot-Line  at
1-800-334-9745.  and  labels will be immediately shipped to you.

Thank  you  for  your  continued   support  and  help  in 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.

                                      Sincerely,

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                        UNIVERSITY/CROP CONSULTANT  LETTtR
 ATTENTION - LABEL CHANGES FOR BRONATE*.  BUCTRJL* AND BUCTRIL* «• ATRAZ1NE
 Th1f  1»  to  Inform  you  that  BRONATE*.  BUCTR1L*  and  BUCTRIL* * Atrezlne
 broadleaf herbicides  htve  recently  been  reclasslfied  as  "RESTRICTED USE
 PESTICIDES"   end  the-t  the  labels  have  teen emended  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
 •pplying.

 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 In
a single  day; 4) Use  of enclosed cabs  when applying 180 or more acres in a
 single day; and  5)  Mew chemigation and  aerial  application restrictions.

Thank  you  for  your  continued  support  and  help  in  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.

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             GROWER  LETTER  TO  BE  AVAILABLE AT-RESELLER LOCATION

 RH6NE-POULENC
f ^^•••••••••••••••^•^^•g^^"^Egg^^"^M^l*^^*IBM^^"l^^^****ll"™*B*****"**™^»*^^"»«*i^^"^"»"^"^»»»»»i^»^^^fcM

 RMONE-POUHNC AO COMPANY


              TO: BUCTRIL»/BUCTRIL« * Atrazine/BRONATE*  Users


   BUCTRIL*.  BUCTRIL*  *   Atrazine  and  BRONATE* .herbicides  have  been
   reclassiHed   "Restricted  Use  Pesticides",   and   additional  label
   restrictions   and  precautions  have  been  added  to  minimize  user
   exposure.

   Pleast  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  childbearing  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  chemigation  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  BRONATE  are registered  trademarks  of  RhSne-Poulenc Ag
   Company.
(9^9) W>-?000
                       -A»«SW£«9AO< APC ATP

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               RADIO/DATA-LINE COPY
ATTENTION GROWERS!

BUCTR1L*/  BUCTRIL* + ATRAZINE  AND BRONATE* HERBICIDES/
USED  FOR P05T-EMCRGENCE  BROADLEAF  WEED  CONTROL/  HAVE
               *
BEEN RE-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 •
              )
 BUCTRIL* + ATRAZINE
       ARE NOW
RESTRICTED USE PESTICIDES
 ASK HERE FOR COMPLETE
 DETAILS AND INFORMATION.
 RHONE-POULENC AG COMPANY

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                         ATTACHMENT O
In lieu of the sentence which states/ "If this product is
packaged in a 30 gallon drum or you will hankie a total of 30
gallons or more of this product per day/ you must use a
mechanical transfer system for all mixing and loading
operations," the complete revised labeling will state, "If you
will handle a total of 3C gallons 01 mor« of this product per
day, you must use a mechanical transfer system for all mixing and
loading operations.  If this 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 hasbeen.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  S

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                                                            rs


    DRAFT   PROPOSED PROTOCOL:  BROMOXYHXL EXPOSURE STUDY



1.0  IKTRODUCTION  '

      A passive dosiaetry study shall be conducted to »ss«ss th«
dermal and inhalation exposure occurring during routine use ef
bromoxynil.  The study shall be designed so that the
Environmental Protection Agency may be able to:  (1) quantify the
exposure occurring during mixing/loading, application, and clean-
up when bromoxynil is applied by ground booa to field crops
employing rigs where boon lengths typically exceed 50'; (2)
quantify the exposure occurring during mixing/loading,
application, and clean-up when bromoxynil is applied by ground
booa to crops where rigs of 20* to 40' predominate; (3} within
each subgroup estimate the total potential dermal exposure and
the actual deposition ta the skin under the clothing worn by each
etudy participant.  As an additional objective, this study or a
seperate study will quantify the potential dermal exposure and
•kin deposition occurring during open pour mixing 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  Site Selection

      The study will addr+ss two main crop groupings.   The first
grouping shall be crops to which daily treatments of 150 acres or
more erf typical and boom sizes cf 50* or greater are the norm.
The usual application speed it expected to be approximately 0.5
acres/minute.  The second grouping shall be crops to which daily
treatment of So to 120 acres is standard and booa sizes average
20* to 40'.  The usual application speed is expected to be
approximately 0.25 to 0.35 acres/minute.

      within each grouping the sites shall be eelected based on
routine use of bromoxynil or other early post'emergent herbicides
in that area.  A minimum ef ten sites are to be used within each
grouping.

2.2  Cooperator Selection             .       .   .	  _

      Cooperators used in the study are to be individuals
intending to apply a post emergent herbicide independent of
possible participation in the study.  The candidates are to be
•elected in a Banner 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
be required.  The questionnaire used should be similar to that
used in the Canadian study.  Selected cooperators will receive

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                             • a  -

 bromoxynil in a Banner identical to a non-cooperator vhe vould be
 obtaining bromoxynil for his/her use except that broBoxyrUl »ey
 be  provided in a non-standard container aa nacasaary to
 effectuate the study.   Rhone-Poulenc aay provide clean coveralls
 and nitrile gloves to study participants.  The study participants
 will  initially be inatructed to  follow label directions.  Should
 the participant attempt to handle broaoxynil with less than the
 label  required protective clothing, Rhone-Poulenc will record
 such  deviation from the label directions and then require the
 participant to utilize all required clothing.  The normal and
 typical work routines of the participants are not to be altered
 once  the-study participant has begun handling broaoxynil during
 the aonitoring portion of the study.

 2.3 Application Details

       Information collected for  each application of bromoxynil
 shall  include target crop,  data  involving cultivar, growth stage,
 date of planting,  and row spacing.  Equipnent information shall
 include sprayer aodel  and aake,  tractor aodel and sake, procedure
 and tiae  required to aix and load the -sprayer and the date and
 aethod of sprayer calibration.   Alterations to the equipaent such
 as  shielding of boons  and opening of windows in closed cab
 tractors  will be recorded.   Application rate and aaount 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 sits for the duration of each
 monitoring period.   A description of each teat sits will be
 recorded.

 2.4  Dermal  Exposure-

       Dermal exposure  to all bcdy areas with the exception of the
hands  will be aonitorsd in a manner that will permit the
estimation of potential dermal sxposurs and dermal exposure to
the skin.   Potential dermal exposure will ba 'monitored by the
Durham-Wolfe patch method (Measurement of Exposure of Workers to
Pesticides,  Bull.  Wld  Hlth Org., 1962, 26:75-91).  Patches shall
be placed in • manner  specified  in Subdivision U of the Agency's
Pesticide Assessment Guidelines  on the outside of the
cooperator's clothing.   Dermal exposure to body arsas covered by
clothing  shall be monitored using either whole body dosimeters
composed  of a long sleeve cotton T-shirt and long lagged cotton
underpants or by a fluorescent tracer technique.  The whole body
dosimeters,  if selected,  will be provided to each coop a rat or 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
 the cooperator gets dressed to perform the day's work routine.
The whole body dosimeter* are to be worn under all clothing

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                            - 3 -

 normally  worn  by  the  eoeperators.  racial exposure aay b«
 monitored by the  uee  of  facial swabbing in lieu of dosimeter*.
 Hand  exposure  will  ba monitored by use of hand rinaa».

      Tha monitoring  pariod vill consist of the handling of not
 less  than 13 Ibs  ac.tiva  ingredient with tha exception that
 external  patchee  will be changed and hand rinses will ba
 conducted at tha  end  of  «ach six/load cycle and each application
 cycle.

 2.5   Inhalation Exposure

      Inhalation  expoeure vill be monitored by use of personal
 •lr sampler*.  The  air samplers 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
 froa  saturation of  the collection media.  The duration of
 sampling  and calibration of air flow will be conducted for each
 eaaple period.

 2.6   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
 daily exposure for  each  job function and the combined nixing,
 loading,  and application functions.  For each crop grouping a
 minimum of ten sites  are to be selected.  For each crop grouping
 a.minimus 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 cabs.  A total of
 at least  40 mixer/loader/applicator replications will be
 conducted for the study.  Monitoring of the exposure resulting
 from the  u*e of the new  2.5 gallon container may be conducted
 either as  an ancillary portion of the study or as a seperate
 study and Bust consist of a minimum of 15 replications of the new
 2.5 gallon container .and 15 replications involving a conventional
 2.5 gallon container.  Each set of 15 replications vill involve a
minimum of five individuals at three different sites.  A
replicate Cor this  portion of the study is defined as one
mix/load  cycle, in which  a spray tank is filled to capacity.

2.7  QUALITY ASSURANCE
                                              •

      All quality assurance as defined in Subdivision U of the
EFA'e 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 *he  use of broaoxynil and the identification of
regulatory option* that say be required to reduce expoeure.

      The data wiil  be presented ae a mean exposur* and a rang*.
The standard deviation will alto be determined.  Non-parametric
or other appropriate statistics say be employed to determine the
statistical significance of different variables in determining
exposure.  Major •ophaiis will be placed on tractor type, boon
size, and tanJc size.  Poet priori analyses aay be conducted on
other variables depending on observed patterns in the data.   A
priori statistical tests vill.be defined in the protocol by the
Agency.                             '
A priori statistical aethode will test the following null
hypotheses: 1) Exposure during nixing/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 same as those involving large rigs; and 3} Exposure during
application from open tractors is the saae as froa enclosed
tractor cabs.  Any post priori statistical analysis will be
determined upon receipt and assessment'of the data.  The Agency
fully rtcognizas the fact that exposure data is inherently highly
variable (C.v. > 100%) and that identification of variables
having statistical significance at p < 0.05 Bay not occur without
requiring an even greater number of replications.  Such an
undertaking would b* prohibitive in cost.  Trend analysis of the
data aay bs 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 I98T


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 Tetrachl on" de.   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 tetrachloride 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
                          (TS-766C)
                          (LE-134A)
                          (LE-132A)
                          (EN-342)
Douglas D. Campt
Frederick F. Stiehl
Stanley Abramson
Peg Anthony
Ken Shi roi shi
David Hannemann
John Martin
John J. Neylan III
Jerry Stubbs
Mike Wood
Dexter Goldman
     Jake Mackenzi e
     Western Regional Compliance Director

     A. Charles Lincoln
     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 Div.

X    Gary 0'Meal, Di rector
     Air & Toxi c Division
                                    Gerald M.  Levy,  Chief
                                    Office of  Pesticides & Toxic  Sub,
                                    Ernest Regna,  Chief
                                    Pesticides & Toxics Sub.  Bran
                                    Larry Miller,  Chief
                                    Toxic & Pesticides Branch
n^3
w
                                    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)  Oata
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 cancel 1ed.

     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 perch!oromethane
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 tetrachloride 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
complai nts.

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.


Regi ons	

0 Will  provide copies of  the Compliance Monitoring Strategy to
  States.

0 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)

Uni royal Chem. Co.
74 Amity 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 30378
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 Valley, 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

FalIs 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 Reg. 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.  Foothil1 Dr.
Yreka,  CA 96097
EPA Reg. No. : CA79027400
                           REGION X (1)
Atomic Chem. Co.
Box 1111
Spokane, WA 91210
EPA Re.g. No. : 6152-5,-6

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        UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                       WASHINGTON. D.C.  20460
                                                      I/
                            JAN 15 1975
                                                    OFFICE OF ENFORCEMENT
SUBJECT:
TO:
FROM:
Enforcement of Administrator's Decision and
Order Suspending Most Uses of Heptachlor and
Chlordane '
Enforcement Division Directors
Pesticide Branch Chiefs

A. E. Conroy H, Director
Pesticides  Enforcement Division (EN-342)
I.  LEGAL DEVELOPMENTS
istrator on the Suspension of Heptachlor-Chlordane (In re Velsi-col
Chemical Corporation, et al. , FIFRA Docket No. 384) oraerea the
suspension 01 "registrations of  all pesticide products containing hepta-
chlor or  chlordane for use on corn, household, garden, lawn, and
turf pests, use against ticks and chiggers, and use  as a'consiituent
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 Agency's 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 heptachior 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, stocks
                                       v/hich were formulated after
         975. are illegal for furthe-r gb-jr^o.-.*  g~ia ^r ,1Cp.

            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 vath directions
provided by the Office of Solid Waste Management.  Disposal questions
maybe referred to RayKreuger 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       ^j
chlordane /heptachlor suspension, please contact the appropriate regiona^J
coordinator.

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.t*«"">,
  triti  *.
      5   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

      ;*                    WASHINGTON. D.C. 20460
                               JAN El


                                                       OFFICE OF ENFORCEMENT
  SUBJECT:  Cltr-icr.tiir. of Heptachlor/Chlordane
             Suspension Order

  TO:        Enforcement Division Directors
             Pesticide Branch Chiefs

  FROM:     A. E. Conroy II, 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., FEFRA Docket No. 384), " dateci January 19, 1975.  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.

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                " UNITED STATES OF Af.CRICA
              fNVlROfWEIITAL PROTECTION AGENCY
                 BEFORE THE ADMINISTRATOR
 I«ituo1  Chemical Corporation
                Reqistrants.
.FIFRA Docket  No.  384
                     CLARIFICATION- OF .
                ORDER OF DECEMBER  24, 1975
     C* January 7, 1975, Respondent EPA filed a Suggestion
purification of the Order of December 24, 1975,  in the above-
                     •                        *     '         +
t*-?\irr.cd  proceeding, seeking clarification of the uses of
•revets containing heptachlor and chlordane for  which
!•?;'.'.I rations are not suspended by the December 24 Decision
«.-..; Cr-Jcr.  Respondent also submitted a Proposed  Order, including
«A 4*.uch.T,cnt setting forth a proposed list of uses not suspended,
••i-;.?:/.cr with certain explanatory notes.      .           .   '
    . On January 13, 1976, Tissued a notice of the filing of
'•*-.;cftJent's Suggestion for Clarification and Proposed Order
«"•• rw.itstcd  written- comments from the parties, thereby
          my intention to consider the possible  need for
                                                         •  .      •
             of the December 24. Decision and Order.*  On   . "
        5, 1976,'v/ritten comments were received  from counsel for
J«Ui:ol Chemical Corporation; counsel for the Pineapple "Growers
'•.:xiitlon of Hawaii and the Attorney General and Department of
                                              considered  therein.

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 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;
                                   *        *   t
 and Respondent EPA.  All of the foregoing parties, except the

 Environ.r.ental  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 alter the .Order .and .that,the.Order Js_f inal...and.cannot, nov/Jie. - -
                                       •        •          *•
 chanced .in the manner proposed by Respondent.       •         •    .'
                    •                                      - • •  *
      Even though not expressly provided for in the Rules of

 Practice governing expedited hearings under the F1FRA, I have

.determined that authority does exist to clarify the Decenber 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 will'be

 served and facilitated by the following clarification of the..
                         •  -     •  .         •     .    •    .  ., •    '••*:
 December 24 Order.           .                         •      •«...""'

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                               3

      In reviewing  the  Decision and Order and the possible need
  *
                .     •               •                    •
 for clarification, I have not considered any new eviuiiuc.* or

 argumentation.   I  have sought only to discern any possible'source'
                                    »*
 or sources of any  lack of clarity in  the expression of my

 intentions at the  time I  issued the Decision and Order.  Comments
        V
 received fron the  parties have been most helpful- in dctern'.ining
                                 *                      *•
 •whether or not  my  intentions  \vcre clearly expressed.  The sole
      *   .  •
 purpose of this clarification is to add clarity to the expression
              *   •
                                 •                               —
 of my intentions at the tisue  I issued tha December 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, lawn, and turf pests

 (both by private hor.ieowners 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, 1976J.  The Order

 further provides that  any stocks of technical grade heptachlor

 oi* chlordane formulated into  products intended for such uses

 [after  July 29, 1975]  nay not be placed in commerce, sold, or used

 for such purposes  or any  other purpose not specifically

.exempted [in the November'J 8; 1974, cancellation order] or_
           .-:-..• ,  •-,.- '/v •>;;•;•  •••
 specifically permitted in'accordance  with the Decision of the  •

 Administrator attached thereto. .                     . «

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     .The  uses  specifically permitted  or  continued  by  the


 Decision  accompanying the December  24 Ordar  include or.ly  those set


 forth in  paragraph 4 of the Conclus'ions  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 the words  "intended  fnr  such uses"  in lino 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.     .           '                   •         r


      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-chlordane, 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 reconimendcd that such other uses not be  continued,  and
 *Uecision of  the  Administrator,  p.  76

-------
                       •  '   ' .5            '     •    •      '.•...

(2) the four uses enumerated specifically in the December 24  .'

Order nrc aironr t'"- <.'sos ns to v/hich sufficient benefits evidence
                 .         '          •
\us 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

carcinogenic tv 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 s'Jspend such other uses, even though  (for the .reasons
                •   •              ' •         '     •         '   '
indicated above) they could not ba enumerated specifically in the
     •                         *    •  • •      •                    «
Order.  . "    '      .     .        '.• '        .        "            •  •
 .
     As to the grouping of uses on "certain fruits and vegetables
                  •                              9                  «
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 v/hich I had used for better documented
                    •                                          •
            •  ,                 «••.             *
  05.   Therefore,  with respect to this grouping of uses, I reached
                     -         *                                •
    tame  ultimate  conclusion as discussed above concerning uses for.
       •-.  •        --     •••'  •-.-•••!.•-•• -.--. r.      •     ': • •  -••      ••
           '        •        "'*•'"
   f"?cision of the Administrator, p. 76.
         •**.-
          -:<**•

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                               .6


   •'a'ny other purpose"  generally,  i.e.  that,  in view of the


   evidence on carcinogenicity risk,  and  in the absence of sufficient


-  benefits evidence,  these uses are  suspended, even 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-peject -£h« .Proposed-.
                                                j  Russell t. Train


   Dated:   January 19,  1976       ".                '-.''-..

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             ATTACHMENT A
                                                                '\
                                                                 I
                                 c USF.S   or cm.onnANv: *. IUJPTACIILOR
                    NOT SUSPENDED 1JY ADMlKlSTHATOH'SOHDliROF 12/24/75
  COMPOUND^)
                  USE(e)
•STATUS OF USE(s)
chlordanc &
hcptachlor • '
chlordane &
hcptachlor
chlordane &
' 4
heptachlor
4
heptachlor
2,3
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
continued
continued
continued until
8/1 /7C only
continued
*
•
J
• .
  hcptachlor
Seed treatment
    continued
 heptachlor	Ant control To achieve pineapple'mealy bug
           t'     .  .                  S
 ,.                  control in Hawaii
                                                   continued
  ehlordane
In Federal/State quarantine programs for
               6                .5.6
Japanese Beetle  and imparted fire ant
    continued
  dilordane
Control of black vine weevil on Japanese Yew
in Michigan	
    continued
  ehlordanc
Control of Texas harvester ant in Oklahoma
    continued
  ehlordane
i
Control of imported fire ant by private
           5.7
individuals
    continued
  ehlordane
Control of white fringed beetle attacking food

crops   In 8 S.E. States (AL.FL.GA.LA.MS.NC.
SC, TN)	   	       	
    continued
  dilordane
Control of soil insects   attacking Florida citrus
    continued
 "ehlordane
Control of strawberry root pests by pro-plant
treatments
    continued
  ehlordane
Control of white srubs in Michiean
    continued
  1.   All registrations Ocderal and stale) 01 pesticide products containing hcpiacmor 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 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.fprmulation 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 Notice.74-11  (39 KR 4*1298} exempted thisiusc from cancellation.  Such use
      was similarly exempted from the Notice of Intention to Suspend.  40 FR 3445G
      (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 subterranean termites on.structural
     .sites such as buildings, houses, barns, and  sheds, using current control
      practices.    i                            .                         *
  4.   Velsicol has represented that it would voluntarily suspend domestic shipments
      of hcpinchlor for this use pending resolution of the cancellation proceedings.
  5.   On the assumption that Mircx 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; use oh'tobacco is suspended.
  9.   Restricted to citrus root weevils.  •   .':.:•'         "•" .

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  s£/7 ?   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY -

^^rMSt^                    WASHINGTON. D.C.  20460
                               «*19 J976
                                                            OF ENFORCEMENT
  SUBJECT:   Status Report on the Heptachlor/Chlordane Suspension

  TO:         Enforcement Division Directors
              Pesticides Branch Chiefs

  FROM:      A. E. Conroy n. Director          A^)
              Pesticides Enforcement Division    Lf /
     The purpose of this informational memorandum is to keep you
  abreast of Agency activity relating to the Administrator's suspension
  of most heptachlor/chlordane registrations.    •                  •    •

     The Office of the Hearing Clerk has completed an uncertified mail
  service of the final  order and the clarification in the heptachlor/chlor-
  dane proceeding to the approximately 42 5. parties  involved .....The Agency
  has sent to the Federal Register the "Notice of Intent to Suspend, " the
  "Initial Decision, " the "Administrator's Decision and  Order, " and the
  "Clarification" for publication.  An expedited publication is expected.

     The "Registration Division is currently in the process of serving'
  by certified mail a notice of suspension to all affected registrants of
  heptachlor/chlordane products.  Please find attached three form letters
  being used  to notify registrants of their products' status under the
  December 24 Order. These letters will apprise the particular registrant
  that it's products.registration (1) has been finally suspended, (2) was
  suspended, but by discontinuing the use of heptachlor and chlordane in
  the product's formulation,  continued registration  is permitted,  or (3)
  was. suspended,  but may continue to_be sold and distributed if the reg-    .
  istration is provisionally amended.         "                    • .  ~

     You will be receiving shortly a region specific.list of all suspended
  registi-ations on the basis of  which you may begin surveillance and
  enforcement activities" to "ensure compliance with  the Administrator's
  order.                    • • ';.                             :      •

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*•'  ^  \                                                        '
I \gtfj7 8   UM1TIZO STATES ENVIRONMENTAL PROTECTION AGENCY
     ~ '
                              WASHINGTON. D.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
     Deceiriber 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 S"imply discontinue the use of Ch-lordane
     or Heptachlor in the formulation of your product.  If.you select this
     approach you will not be required to submit ^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,may 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 which all references to suspended uses have been deleted.

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        UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

         1   '              WASHINGTON. O.C. 20460
CERTIFIED HAIL
                                                        ••r •..*-.-•- '••. ••-..  •
Gentlemen:      '  .-•"  '-.-•-' "•'•-  '*•  .'
                   *•   '   "    •

Subject   :  Notice of Suspension  for:.
                                           t V
•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 v/ere  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 amendment of registration.  Such petition •
 should  request the-'elimination from-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>Wocked>5out'.v:; The "granting by-the Agency of such
 a petition will  permit:y.pu^                      and/or sale of Hepta-
 chlor and/or Chlbf.cla'ne"';fp^                           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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         UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                  '     '     WASHINGTON. D.C.  20450  " '      •
'  CERTIFIED MAIL
•   i

      .' •'.
  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 _forth 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 orjused after July_ 29; 1975..     	    •

  .The^Administrator.'s Decision and Order? wilj be published'in the Federal

      •••"••.':•. :"". •',•';; i- *•.:'.•.:  ' '  ' .«-•••• .'   ' ••:•.. -,    .  "  •';"••" ; -''   '' •••
      ;;'. .  . .-' -•' /-.v. * i- ',';'.'."' '• •   ->'- ."'..-.. - I-.- - • •«.    ..." '•':**•' -.  '	'   '  '
  Sihcerelyryours, :    : ••:''";-;-'>ir;/^:^-:!--^''^-'^--fe r: ":••>..'•''' .-.."
  John B. Ritchi, Jr.  -.  •   -.  .. "
  Director                   '    .
  Registration Division  (WH-567)

  Enclosure  ;    .      *

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                                   -2-

It is sufficient to send a cover letter with an srr.ended label  or labd
'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 with the enclosure must 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. wjjl_not..abj:04}ate_y^                                  —
honsuspended  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 appr(
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-567J
                          •  ^^»
            •       •*
 Enclosure  •

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                        SPF.CIF1C USL-  _.  v..
               \'  NOT SUSl'EKDEP BY ADAUN'l
                                      or ciiLonoANK /• •• r:rTACin.oK
                                      DAltNISTIlATOK'r.OliijU'U OF 12/2-1/75
COMrC)UND(s)
Chlordane &
heptachlor
ehlordane t*
heptachlor
ehlordane &
4
heptachlor
4
hcptachlor
heptachlor
.beptachlor
USE(s)
Subsurface ground insertion for termite control
2
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
control in Hawaii
STATUS OF USE(s)
Z.3
continued
continued
. continued until
8/1 /7G only
continued
continued
continued
•
ehlordane
               In Federal/State quarantine programs for
                               6                     5.6
               Japanese Beetle  and imported fire ant
continued
ehlordane
ehlordane
ehlordane
Control of black vine weevil on Japanese Yew
In Michigan
'Control of Texas harvester ant in Oklahoma
Control of imported fire ant by private
5.7 •
individuals
continued
continued
•
continued
ehlordane
                Control of white fringed beetle attacking food
                      B  .                    '       •
                crops   in 6 S.E. States CAL.FL.GA.LA.MS.NC.
                SC. TN)
continued
chlordane
                Control of soil insects  attacking Florida citrus
continued
chlordane
                Control of strawberry root pests by pre-plarit     .   continued
                treatments
chlordane
                Control of white erubs'in Michigan
continued
•3.
 All registrations U'cocrai anc aiaiej ot pesucioe products containing ncpiicmor and
 ehlordane 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.                   •
 PR Notice 74-11 (39 PR 412?3) exempted this use from cancellation.  Such use'  -
,was similarly exempted from the Notice of Intention to Suspend. 40 FR 34456
 (7/29/75)..      •:-.- :».•.-.                       .                          -
 Clarified at 40 FR 30522 (7/21/75) to apply to the use of cmulsifiable or oil
 concentrate formulations for controlling Mibtcrrancan termites on structural
 sltea such as buildings* houses,  barns, and sheds, using current control
 practices.                                                 '.
 Veloicol has represented that it would voluntarily suspend domestic shipments
 of hcptachlor for this use pending resolution of the cancellation proceedings.
 On the assumption that .\iircx is  not available.      '    .              •
 To include treatments required to certify to pest free conditions as well as for
 use in suppression and control programs. ''
 To include use on both public  and private property by either owner, agent.
 employee, or contractor.'     .                      .                         • .
 Not intended to  preclude use on cotton.  However, use on tobacco is suspended. •
 Kcslriclcd t<> citrus root weevils. _                    .;
           r                  -  •   .-•'.:.   '         • .          ./•
 4.

 5.
 fi.

 7.

 8.
 8.
                                                                                            . rr

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                      '•'••'   '.: '  •  -2-

                      • Mr. Timothy A. Gardner
                       Product Manager (15)
                       Registration Division (WH-567)
                       Environmental Protection Agency
                          ihington, D.C.  20460.
The amendment will not abrogate your right to defend both suspended or
nonsuspendecl uses .in the continuing cancellation proceeding.
                                                             •
Existing stocks of EPA registered pesticides containing Heptachlor or
                      '
stocks- v/ere formulated prior to July 30, 1975.  This date v/as 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 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 v/i 11 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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   3   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

              •        WASHINGTON. D.C. 20460
                           2 3 MAR 1976
                                                  OFFICE OF ENFORCEMENT
SUBJECT: Heptachlor/Chlordane Suspension Order
           Enforcement Strategy

TO:.    - .,. Enforcement Division-Dir-ectoES—
           Pesticide Branch Chiefs
FROM:    A. E. Conroy II, Director
           Pesticides Enforcement Division
                                          r
     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 12/24/7Fprfor 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,  may be sold.
         distributed, or used for suspended uses.

      (3) Stocks of heptcxrhlor or chlordane products formulated
         gfter July 29, 1975 may be sold, distributed,  or used
         only for exempted uses, as per "Attachment A".


 H.  CATEGORIES OF HSPTACHLOR/CHLORDANE PRODUCTS '     _ 	•-•''

      As stated above, there are three categories of heptachlor/chlor-   ...    .
 dane products:

     (A) Federally registered products, all uses of which have been     -—__•_
 susp'ehdecEThe Registration Division/Office of 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 regisfeced    —•- -
 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	
 suspendecTAs noted in the introduction and in previous memoranda,  "
 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"] 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
  ij see myj? eoruary 19, 1976 memorandum entitled "Status Report on the
 Heptachlor/ Chlor dane 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
 apprise-this category^rf~r^gi-sti>aiits~asi'to''ttieii'''prDdgctg<''statti5:	
 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 for 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 similarity 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 jwith those provided for in the Pesticides Enforcement
 Division Ciase 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 ,~.~.~-
 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: .;.
 i
    (A)  Federally registered products, all uses of which were sus-
 lended and which were formulated alter July 29,  1975.  As per recall"
 nitiation 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,- •.&.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.
            ". • "'•'?.» -'•.•* : .:
               • •**.-• .J #• -  *
            •'••."•.•••'• ••''"-•  " •

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                               -5-


            (11)  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  f

    (B) Federally registered  products with both suspended  and con-
 tinued uses and which were formulated, after July 29, 1975.   As soon
 as these products can be  identified as to their registration status, FED
-wiH request ^a^h-regtgtraTit-'tO'^^nta^tnciJrkTrowtrdistritmtorsT' whole'-	
 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;
 z/  Registrants: should be informed-thafthe 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 utilizationof 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-
-flS Refter?"1?y r«?-gi-S^-r-
 [category A products J.

      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,r-enforcementactions,-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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                            •   - 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.


VIE.  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 12/24/75.-"""

        (2)  Copies of recall request-letters sentrto registrants by
            FED.

        (3)  Three form letters sent by RD/OPP  to "intrastate"
         .:  heptachlor/chlordane registrants.

        (4)  41 FR 7552 (February 19. 1976) — "Velsicol Chemical
      _________ Co. etal . , 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 pf the 48 "intrastate".heptachlor/chlordane products,
           .all use of which were suspended [category C products].    --

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        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 OrMer
        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 Uf ebruary 19, 1976) that

      the benefits of continued use of heptachlor and chlordane to
      coijtrol 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 required 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."Keg. 7552 (February 19, 1976).

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                              -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      . v
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 violating the 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
    •  »*/  To arrive, at a result consistent with the Administrator's intent to
suspend all use of chlordane/heptachip^. on corn, regardless of target pest,
the use of flies e 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     AIHEX CHLORDANT2 8E
2635-131    RED TCP CHLORDANE 8 SPPvAY
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 Jmecember 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 [§1 2(a)(2)(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?/ ^e 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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STATES ENVIRONMENTAL PROTECTION AGENCY

        WASHINGTON. D.C.  20^60
                                     OFFICE OF ENFORCEMENT
                             ..CC^^T*
To:     Enforceme.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-b.ecame completely
effective as to all subject products formulated after August 29, 1975
and not already cancelled.  The  recall of subject products initiated in
March 1276 is no\v essentially complete 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,  1S7U)). 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 v/ill 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 crrse of firms refusing to rr.-cnll.
Additional visits to producers and/or distributors may 3s 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-t-he level--ofjaction-"to"be~applied"'atthe	
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 ENVIROKMSNTAL PROTECTION /•.•". i ;. ;CY •   -v'« A< ,? t«..:./ .'.
                                    120CT  1976
        Mr.  Kalpii L11-1 siJ'  "  , •
        executive Director
       • Chemical Specialties- t-i&r,
          Association, Incorporated
        1001 Connecticut Avenue,  N.i;.
       , Suite 1120        '-i           •     '"*.'•
      •  Washington, ;-. C.   2003&          ':    .       .     '

        Dear Mr. Ur.qel:                ..                 •        "

             Vour itittcr of 7
        would >:2 ' improper under the Agency's rules  of practice
        for  him to respond  to your  inquiry.

        •f    your letter asks that  the Adsiniutratof invoke the ". .
        "special rult"/umier ^15{b)(2), in order  to allow inven-
        tories of clilor<3ane products t'oraiulatod bctwc-»n vTuly  29,. ;
        1975, ana ixscemuer  24, 197T», «nd currently  on asalor
        shelves, to be sold until such. f>tocks: i/re exhausted.

       .      Vour request would -necessitate nso-iificaticn o£ the    ;'
        order issued by the Administrator'on Dccewoer 24> 1975.
        Requests tor such Modifications must be r.iode in cont'oraance
        v/ith the rules of practice  set forth  in 40  CFR Part 164.
        So*  especially 40 CFV< Io4.6(b), concerning  'enlargement of
       'filing periods; 40'.CFU 164,31, corrcerninq intervention;
        anJ  40 CFK lu^'.ilO," conccrnin-T Wv-.cicns  for  reconsideration
       •'of orders.        '                   •                       "
  Ml

SUtNAJKI
                                                               OFFICIAL. I-ILE COi-

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                              -  2  -

                              •
      Finally, condor requires  that  I  infonn you that -the
Aqency statf would oppose  any  CUCD  motion to itioiiify trie* .
.suspension order, snould one in  fact, bo  filed.  Essentially*
this  is because the suspension order  is  a temporary order,
which ultimately will be st'cerceJed. t;y an order at the
termination of the cancellation  proceeding. .The question
of  thft extent- to v?hich distriouticn of existing stocks ot
c.h.'oraanc proi»v.cts should  be allowed  can and shoulc) be
aUcrossed in tho ccncella-tion  procjaui'rKj, an<3 resolved in
the order at tlis conclusion  of that proceeding.  Sound
:copsic5erations of proceaurcl n«an«qenont  militate against
interruption of the cancellation proceeding to consider •
this  question at "this time.      t
*      * *
   ••t  '•''*''   • *    •.".'•**     .          •
                                Sincerely,*-.
                               G. Williaa Prick
                               General 'Counsel  (A-13CJ)

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CHEMICAL SPF.CIALTIES MANUFACTURERS ASSOCIATION. INCORPORATED
        execute.* w«i c'.r • sus'E i»2J « ««#i COMNICTICUT AVE.. N.W« WASHIUGION. D.C. J003C • (?02)«?2-ono
      August 30, 1976


      llr. Russell E. Train
      Administrator, EPA            .                    .
      •401 M Street, S.W, , Room W1200
      Washington, D.C. 20460
                                         •                        *
                                    •                             •
      Dear Mr. Train:         ._         .  .          • -• '

      On August 16, CS14A 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 chlordane product-6 formulated between July 29,. 1975
      and December 24, 1975 and currently- on dealer shelves to
      be sold until-such stocks are exhausted.
                                              •   f     * •     • •
      There are several reasons for this request:

           1) Recall is in most cases a practical impossibility
              and constitutes an economic hardship, particularly
              to smaller formulators.   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 chlordane pro-
              ducts docs 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 shc?.ves 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 beerTinvoked.  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, we 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.so wJth
.respect to products formulated prior to the Suspension
Order.                                  •
                *                  *          »

I look forward to hearing from you  concerning this impori
tant matter. •                         .
 Ralph/Gngel
 Executive Director
 REtkas
 cc;  A.E. Conroy

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            UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                        WASHINGTON. D.C. 20460
                           APR I  3
                                                  OFFICE OF
                                          PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM

SUBJECT
FROM
TO:
  Revised Compliance Strategy for
  Suspension of Chlordane and Hep

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

  Addressees
                                      ion and
                                     'ticides
     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 a! 1 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
     u
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 In that Notice are cancelled (see Appendix C for
this list), and that 1t 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 "Chlordane/
 Heptachlor 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 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 Stle, 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  5,
 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 Register, or after completion of the suspension
 heari ngs, whi chever is later.   OCM will inform the Regions when
 the  April 5, 1988 chlordane/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 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.  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 Chi ordane/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 in 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 1n 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 chl ordane/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 1s  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

-------
                                 ADDRESSEES
cc:
      Douglas D. Campt     (TS-766C)
      Edwin F. Tinsworth   (TS-767C)
      Frederick F. Stiehl  (LE-134A)
      Mark Greenwood       (LE-132A)
      A.E. Conroy II       (EN-342)
      Connie Musgrove        "
      Ken Shiroishi          "
      Phyllis Flaherty       "
      John J. Neylan III     "
      Mike Wood              "
      Jerry Stubbs           "
      Dexter Goldman         "

      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
                                 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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                             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 Velsicol 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 Velsicol  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 Velsicol were not affected by this agreement, and
were  therefore not prohibited from sale, distribution, or use of
existing stocks of Velsicol's termiticldes under existing labeling.

    Under the terms of the MOU, EPA  also granted Velsicol a
conditional  registration for certain uses of  some  of Yelslcol's
chlordane and heptachlor products.  Velsicol may only distribute
these conditionally registered chlordane/heptachlor  pesticide
products as Restricted Use Pesticides 1f air monitoring  tests
 reveal  zero exposure from each use,  anT~provided 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  1f and
when  Velsicol has met the terms of  the  conditional  registration,
and therefore,  when Velsicol 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 Roister on
 November 3, 1987  (52 FR 42145).  Under the Cancel" atlon  Order,
 Velsicol was still  prohibited from the sale and distribution  of
 its  chl ordane/heptachlor termiticides; however, existing stocks
 provisions  were  established which phased out sale, distribution,
 and  use  of  Velsicol's chl ordane/heptachl or termiticides  by  persons
 other  than  Velsicol.  Between December 1, 1987 and April 15,  1988,
 stocks of Velsicol's chlordane/heptachlor termiticides may  be
 sold,  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-Yelsicol
 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/Heptachlor
 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 existing
stocks provisions of the April 5, 1988 Suspension  Notice which
affect persons other than registrants will only take  affect  30
days after the date of  publication in 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-
 REGULATED  INDUSTRY
     The sole producer of technical  chlordane and heptachlor  In  the
 United States is 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 chl ordane/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 chlordane/heptachlor 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-Vels1col registrants) were  not  affected
by this agreement.

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                  •Ffd»ra! Register  /  Voi  52  No. 2:2 ' Tur-sd.iy. Nov.-r-.l-pr 3.  196? / Noiir.cs
 - '.; ;   ..  '  "'• s: j!l be riddc vvith
  ;••••• .:, f ,,-•.., !!..,:-. 50 p s ;  at the
 |:-. .v." .ivr.;: .1 r.Ltj-Sf- spr<»y nozzle
  ••••• • :. <--<.!ut.-i:sri;r.;: horizontal barriers.
— 1: i '.-.rrc-'r S!JL/S cannot be  poured
   ;:s v.T.ich will be covered by
d:nr ri/tp. After the final exterior grading
is i c-rr.pletcd. vertical barriers may be
created in back-fiilsd soil against
foundation walls or against the outside
of mcnolith:c slab. To produce a vertical
harnpr. apply the emc!s:on at the ra'.e of
•4 Ci'lii'ns per linear fret per foot of depth
froir. pr.ide to the top of the foottr.-. For
r-"':;.-h!hir si.ihr  apply to the bottom of
— i .-\.\ pressure rriidinc and/ur
  :•• r.-:::r.K .ir. plications should net be
  ~.  :• bf!uw the top of the fcc-imp
  'except whrn the footing is exposed Jt
  or iiLc'vr grade. Specie! care should
  bf laia-n to avoid soi! washout around
  tS.  footing
— When redding, use cniy  low pressure
  (less than  25 p.s.i. at the nozzle). 1; is
  important  that emulsion reaches the
  footing. Rod holes should be spaced to
  provide a continuous barrier.
— Trenches need not be wider than 6
  inches.
— Emulsion should be mixed with the
  soil as it is being replaced in the
  trench. Cover treated soil with
  approximately 2 inches of untreated
  soil.

C.'cwl Space Foundations
  For crawl  space foundation*, vertical
barriers may be established in the soil
on the outside perimeter of the
foundation using a rate of 4 gallons of
emulsion per 10 linear feet per foot of
depth from grade  to the top of the
footing. Application may be made by
low pressure rodding and/or trenching
to the footing. If the footing is exposed
at or above grade, application should be
nude with special care to  avoid w;i«h-
o".\ around the footing.
— Do not treat the footing through
  hollow masonry voids.
•—Rod h.i'ics srould L' 
-------
                                       Vol.
                             N.
.:*::urt,.>r
   V.r1. ,i; li.irnr.-b rr..v. !«• i vl.,i.',,li( J
.ii.it:i tni- ti'.i->> be applied only
by tri-r.ch-.r.g or the excavation
technique below ct a rate of 4 gallons of
r.r.ulsion per 10 Imt^r feet per foot of
depth to he treated. Where exterior
sLilis arc adjacent to the foundation
wall, drill through the slab along the
outside of the wall  at a spacing that
provides application of a continuous
b.irrYr ard apply the emulsion jusl
tinder 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 complete 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.
E\cavation Technique
  If treatment is to be made in difficult
situations such as near well* or cisterns.
along faulty foundation walls, end
around pipes and utility lines which lead
downward from the structure.
application must be made in the
following manner to avoid intrusion of
termiticide 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 rale of 4 gallons
  of emulsion per 10 linear feet per foot
  of'lr;nh nftJ"- !rrnrl:. M:x t!ic
  c'l'iiNii'ii 'iinn:ii:l'!v' in:o the sn-1
  I.IK.:'I. i..lit t. ; M \t:nl liv,uij f4.)in
  nir::-..::,: jff t; •• !ir., r.
—After l he trc.itcd so::  l;js liru J
  .•iJi'tfii.ilr';. ri-j'ljci- i!.t .ml  .n tl.p
  ircr.i.h and cover with iiri'roxi-i..iL-ly
  2 :nchrs of untreated  soil.

fict.'catnirrn: Rt.-strictions
  Retreatment for subterranean  termites
should only be made when there is
evidence of reinfcstation subsequent to
the initial treatment, or there has been
disruption of the chemical barriur in the
soil due to construction, excavation.
landscaping, etc. Kctreatment should be
made as a spot appiictttion tc  these
areas.
  Re'.rentmcnt1; 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 1.1987.
supplementary agreement between EPA
and Vclsicol. can bj obtained from the
person listed under FOR MORE
INFORMATION CONTACT:
  Dated: October 23. 1SC7.
Douglat D. Campl.
Dircctur. O'f.ce off-isticiJf /'nj^rtfrni.
|FR Doc 87-15383 Fucd 11-2-87. e.-JS «m;
DILUNC COOC «S«0-5*-U
IOPP-180747; FRL-3286-51

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 cyanemide ("Dormex") to
promote uniform bud break in 18.600
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  S. !_'.!.T. I'r.it" ... M .-

of Pf.stii	• I'mri jn:> K..-* i:.-i.
PruliM.t.i'ii A^t-niv. 4U! M S::.-i
W.is!:ni-j'i!i.. D.C Jl>;oi>.
   in ucisnn. bn:ig comment* lo. Iv:n Z.iu.
Cr\st.il Mai! =2. 19C1 )rf.ror^(in D.IMS
Highway. Arlington. VA.
   Information submitted in ar.y
commnnt concerning tins notice r.i.iy lie '
rlaimed confidential by marking any
part or all of that information ns
"Confidential  business Information
(CBI)." Information so marked win rot
be disclosed except in accordance with
procedures set forth in 40 CFR Part 2. A
copy of the comment th.itdors contain
CO! must be submitted for incLsmr. :r.
the public  record. Information not
marked confidential may be disr.ioscd
publicly by EPA without prior ncticr to
the submitter. All written comments will
be available for inspection in Rm. 230 at
the address given above from 8 a.m. to 4
p.m.. Monday through Friday, excluding
legal holidays.
FOR FURTHER INFORMATION CONTACT:
By mail: Libuy Pemberton, Registration
Division (TS-767C).  Office of Pesticide
Programs.  Environmental Protccticr.
Agency. 401 M Street. SW.. \Vashingto.-..
DC 20460.
   Office location and telephone r/u-nbct"
Rm. 716. Crystal Mull =1 19:: Jfl
Davis Highway. Arlington. VA.f
557-1800).
SUPPLEMENTARY INFORMATION: Purr.uar.t
 to section  18 of  the Federa! Inscr.tir.de.
Fungicide, and Rodemicide Act (FIFRA!
 (7 U.S-C. 136p).  the Administrator may.
 at his discretion, exempt a State agency
 from any provisions of FIFRA if he
 determines that emergency conditions
 exist which require such exerr.pticr..
   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 SKU'
 Trostberg Aktiengesellschaft. to promote
 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 table
 grapes. Vitis  spp.. are grown in the
 Coachella Valley. The Applicant
 indicates  that California growers nf  ;
 early market  table grapes arc f.'ictr'g
 economic losses due to ir.creas.rg
 competition from fore:pn irrpcrts.
 particularly from Mo.vco. The .A

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 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 SEC 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)  (Hl-850003).  The cancellation
 order also affects Velsicol 's  supplementary 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)(111)] 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 is 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 in 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-
 Existing 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 person may 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,
 suspended  chlordane and heptachlor termiticides.

 COMPLIANCE MONITORING

     Conformance with the August 11, 1987 MOD 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/retailers,  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.

     Regions/States will also investigate all tips and complaints,
 as appropriate.

     Please note, registrants of the suspended products have already
 received SSURO's 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).

 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 chl ordane/heptachlor  products
in violation of the cancellation orders, suspension orders,  or
SSUROs.

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                               -8-


Dis tributor/Dealer/Retal1 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
products are being sold and distributed in accordance with  the
October 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/
retailer level to assure that remaining stocks of suspended chlordane
ana heptachlor termiticides have  not been moved and are  not being
sol d.

User Level
     During routine use inspections prior to April  15,  1988,
inspectors will assure that Velsicol's chlordane and heptachlor
is being used only by certified applicators and in  accordance
with the use directions found in 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-Velsicol 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 application.
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 and
  heptachlor products agree to voluntarily cancel their ?*oducts.

  Will notify OCM if 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.

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                              -9-


Office of Compliance Monitoring
0 Will develop and transmit the Compliance  Monitoring  Strategy
  to the Regions.

0 Will issue SSUROs for non-Velsicol  chl ordane/heptachl or
  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	

8 Will provide copies  of the Compliance Monitoring Strategy  to
  States.

0 Will distribute  lists of products  to the  States.

° Will  conduct distributor/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-Velsicol
  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-
0 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-conformance 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.

0 Will notify the States when Velsicol has met  the terms of
  the conditional registration, and therefore when Velsicol
  may sell the conditionally registered products.

0 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.

0 Will conduct a books and records inspection of non-Velsicol
  chl ordane/heptachlor registrants to  determine the first-line
  distributors of those products.

0  Upon identification from the books  and records inspections,
  States will transmit information on  the identity of first-line
  distributors to the Regions.
o
  Will take enforcement action, including issuing SSUROs, as
  appropriate, provided they have the authority.

0 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 Chlordane/Heptachlor Compliance Monitoring Strategy, the
  first report is due April 7, 1988.

-------
Establishments  Producing  Velsicol's  Chlordane  and
             Heptachlor  Termiticides
                   00876-IL-001
          Velsicol  Chemical  Corporation
              Box  39A  II 1 1 noi s HWY  1
                Marshal 1 ,  IL  62441
                   00876-TN-001
          Velsicol  Chemical  Corporation
               1199  Warford  Street
               Memphi s , TN  38108

-------
                APPENDIX  A

       Retained  ana  Deleted  Uses of
 V e 1 s i c o l ' s  Cnloraane/Heptachlor Products
Velsicol classified che following  uses  of

ics end-use termiticide produces  as

"deleced uses":

  a.   posc-conscruccion 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 basement-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 ot 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 termiticide

produces as "retained uses":

  a.   application to the outside
       perimeter of any structure by
       trenching, or drilling .through
       sidewalks, patios, o.r other
       unenclosed slabs, and applying
       material to the soil without
       pressure (e.g. , flow or gravity
       feed);

-------
                  -2-

               APPENOIX  A
  b.    applications by Che excavation
       technique to the exterior of any
       structure (i.e., by removing soil
       next to the foundation,  placing
       on a carp, creating with
       terraicicide, and placing back in
       crench after soil dries);

  c.    pre-construction low-pressure
       (maximum 25 psi) vertical rodding
       (with the application rod equipped
       with a pressure control  device to
       prevent higher pressures) of the
       perimeter outside any structure;

  d.    post-construction low-pressure
       (maximum 25 psi) vertical rodding
       (with the application rod equipped
       with a pressure control  device co
       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 che
       application rod equipped with a
       pressure control device  co prevent
       higher pressures) under  che slab of
       slab type structures.
     The agreement classified one use, che

proteccion of underground cables, as an

"unaffecced use".

     In addition co chis classificacion of

che uses of Veisicol's  cermicicide products

the agreement included,  iacer alia,  che

tollowing provisions:

0  The recained  uses were converced  to
   rescricted uses as  provided  tor  in
   Sections 3(d) and 4  of F1FRA;

-------
 /
ft
                      - J -

                   APPENDIX A
           The regiscracions of 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 products 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
           tensiticide.

-------
                           APPENDIX B

             Supplemental Registrants of Velsicol
               Chlordane/Heptachlor Termiticides
 (d?6-G3053-000192)

 (376-00053-000430)
(376-00063-
(376
(376
(876
(376
(376
(376
(876
(376
(876-
(876
•00063-
•00063-
•00063-
•00053-
•00063-
•00035-
•00086'
00086-
•00086-
00036-
•00086-
002935)
005887)
010370)
025030)
034704)
043227)
035034)
000016)
000192)
004876)
005887)
00:387)
(876-00036-005887)

(876-00086-006723)
(876-00086-010370)
( 376-00036-012000)
(376-00036-012000)

(375-00036-034704)
(376-00100-000192)
(876-00104-000430)
(376-00104-001812)

(876-00104-004876)
(876-00104-006723)
(376-00104-025030)
(876-00104-042761)
(876-00233-001927)
(876-00233-006754)
                                                            /Termi te Use
Termite Killer For Use
Drexol Chlordane 725 Termite Spray for
Professional  Termite Use
Durham's Cnlordane Emulsifiable Consentrate
Insecticide for Use Only By Professionals
Red-Top Cnlordane 8 Spray
Black Leaf 721 Chlordane Emulsifiable Concentrate
Ford ' s Chiordane 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,
AG Chlordane 4-EC Termite Control
Black Leaf 45X Chlordane Termite Killer
Black Leaf 45% Chlordane
Around Buildings
Black Leaf 45% Chlordane Emulsifiable Consentrate
Insecticide
Red Wi ng Chiordane 4 EC
Ford ' s Chlordane 4 EC                        •
K Mart 45% Chlordane Termite
K Mart 45% Chlordane Termite
Bui 1d in g s
Pro-C hiordane 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 Wing Chlordane SEC
Red Panther Chlordane
Red Panther Chlordane SEC
Terminix C-H
Orkil 2X
                                            Killer
                                            Killer
                                             for  Use Around

-------
Plot I:.
              Siiis isiTiu AS
COSPAR!
AKVA: CHEMICAL CCEP.
4100 MST  HAS5INSTC1 BLVD
LOS AS'iLES    CA 90023

AHVAC CESKICiL CCS?.
4100 EAST  HASEir/ON SLVO
LOS HGELES    CA 90023

1MVAC CRWCiL COB?.
410; EAST  W.SEISGTOH BT,V?
LOS ASG-LES    CA 9C":23

ASVAC CHEMICAL COS?.
41 Ci BUST  ttAS-lKr-jli BIVE'
LOS ABGELES    CA 90C2J

AS C-EKICA:  cos3.
1514 ELEVE5TE "
POE'SKOGTi    OE 45662

AS CE-».1CAL CCiF.
IV:4 EiEVES'r. ST
Pr-ETi*;:::    OE 456*2

AH CH^:.:AL COH?.
1514 ElEVIST: ST
tCHTSROCTH    OE 45662

B & G CCf.PASK
10539 tKWl M BOX 20372
DALLAS        ?X 75220

BLACF. LEA? PSODUCTS CO.
667 S STATE ST
ELGIS          11 6012!;

BLACK LEA? PRODUCTS CO.
667 I STATE ST
ELGIN          IL 60120

BOHDIE CHSiCW,  CO.. BC.
2 mi AVE.
WPJV.LLE      SK  13495

80S!':! CH:«ICAL  CO..  ISC.
2 i'Fi AVE.
KOS'VILLE      n  13495

EOHL'!2 CHEMICAL  CO.,  ISC.
i «:s: AV-.
KOSFViLLE      «  l.'4?5
          of  Products  Containing
        rdane  and Heptachlor
        :  ci SI:T::R JicitiiiB)-
        «:•• FIFEi

       .1   PE::L:T i CEHICAL
54bi   223
548.  226
5481  315
5461  50
7122  121
7122  3
           CHLCSDASE
           CELORL'ASS
            CHLOBDASE
            CHLORJAS:
 86:2  66
 5i6?  127
 58??
 4     274
 4      2?5
 4      286
            CHW5DAS:
            CHLOF.DASE
            CHLORDASE
            C-IORDASE
            CHLOSI-.'.SE
            CHLOSI-ASE
ss iss:i:  LI?::A:: ?•;::!«  ."r


01/06/88    /   /   OS     CA



01/06/88    /   .'   09     CA



01/06/88    /   /   09     CA



01/06/88    /   /   09     CA



01/06/88    /   /   05     OF.



01/06/88    /   /  • 05     OE



01/06/68    '   /   05     OE



01/06/88    /  /   E6     TI



 01/06/88    /  /   r:5      ".



 01/06/88     '  /   C5     IL



 01/06/88    /  /   C2     SY



 01/06/82     /   '   -.1     V.



 U!/0^'ifS     •   -   *.i     S':

-------
                           APPENDIX B

             Supplemental Registrants of Velsicol
               Chiordane/Heptachlor Termi ticides
(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)
•OOS887)
•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-
(876-
•00086
•00086.
•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)
Drexol 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% Chiordane
Around Bui 1di ngs
Black Leaf 45% Chiordane
I nsect i ci de
Red Wing Chlordane 4 EC
Ford ' s Chiordane 4 EC
K Mart 45% Chlordane Termite  Killer
K Mart 45% Chlordane Termite  Killer
Build i ngs
Pro-Chlordane 4-E
Dexol Chlordane Termite Spray
Durham's Chlordane 8E3 Emulsifiable
Pee Gee 8 Ibs. per gallon Chlordane
Concentrate
Chlordane-8 Termite Control
Red Wing Chlordane SEC
Red Panther Chlordane
Red Panther Chlordane SEC
T e rm i n i x C - H
Orkil 2X
Termi te Ki11er For Use

Emulsifiable Consentrate
           for Use Around
           Concentrat e
           Emu!si fi able

-------
                           APPENDIX C
                     CHLORDANE  CANCELLATIONS

COMPAITY             EPA REGISTRATION NO.           EFFECTIVE I

Bonide Chemical           4-96                      3/17/88
                          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

-------
ut.xol  Industries
Tobacco Stares Chemical
Company
Chevron Chemical
Company


FMC Corporation


C.J. Martin  Company

Residex Corporation
192-42
192-43
192-132
192-133
226-177
226-184
239-478
239-1232

279-383
279-538

299-171

373-26
                                                  j / 3 0 . S c
                                                  3/20/8S
                                                  3/30/85
                                                  3/30/88
4/27/87
4/27/87
3/25/87
3/25/87

3/07/87
'11/01/86

3/25/87

3/25/87
 Imperial  Incorporated
Boy1e-Hi dway  Inc.

Rocklar.c  Chemical
Company incorporated

Kaviland  Agricultural
Chemical  Company
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
 3/25/87
 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 Gil Company
Security Lawn and
Garden Products Co.
Faesy i Besthoff
Incorporated

Chas. H.  Lilly Co.

Green Light Company


Velsicol Chemical Co
Miller Chemical &
Fertilizer Corporation
Cre-O-Tox Chemical
Products Company
Seacoast Latoortories
Incorporated
Cotton States Chemical
Company


Land 0'Lakes
Universal Cooperatives
Incorporated
746-53
                          46-1 19
769-90
769-511
779-82
802-71
                         J  - D ' v •
                         3 • 25 • f
                         3/15/87
3/25/87
3/25/87
6/02/87
9, 11/8T
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
3/25/87
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

-------
L><-.-: tiebach cnemicai
Corporat i or.
FCX ,  Incorporated
Griffin Corporation


Tria.'igle Chemical
Cc.-.par.y
Terir.inix Division
of Cook Industries
Incorporated
ELCO Manufacturing Co,

Farmland Industries
Incorporated
r.-.'.R. Grace & Company

FBI-Gordon
Corporation
Hopkins Agricultural
Chemical

Colonial Products
Incorporated
LaRoche Industries
Earl May Seed & Nursery
L.P.

Stephenson Chemical
Company Incorporate
1336-324
1386-353

1421-23
1598-145
1598-244
1812-242
1812-243
1S42-41
1842-42
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
     d / 2 0.' 8 ~
     8/20/67

     3/21. SS
     4/27/37
     4/27/87

     7/01/87
     7/01 /87
     5/14/87
     5/14/87
     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

-------
                          'O -
H~dvood Chemical,
Incorporated
Coastal Chemical
Corporation

Chacon Chemical
Corporation

GRO Chemical
Company

Helena Chemical
Company


Octagon Process
Incorported

ArChem Corporation
Forshav Chemical
Company
Voluntary Puchasing
Group, Inc.
B & G Company

Sunniland Corporation

Nationwide Chemical
Products, Inc.

Ross-Daniels, Inc.

CornJbelt Chemical
Company
4931-5
49S1-5
                         5549-41
                         5719-24
                         5778-33
                         5905-97
                         5905-102
                         6830-15

                         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
                                             6/29/87
                                             6 / 2 9 / S 7
                    3/17/88
                    7/01/87
                    6/11/87
                    3/25/87
                    3/25/87
                    7/01/87

                    3/17/88
                    3/17/88
                    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
                                             3/21/88

-------
 :-'•: :'d "s  Cae-.T.i ral i.
 Service Incorporated
Hacie:;da  Enterprises

?u_~a Chemical  Company

Lrexei Chemical Ccnosnv
r-cite Chemical
Plat
Ccrr.pany
Falls Chemical



Kaw Valley,  Inc.


Wilson Laboratories


Caneron  I-'.  Bairc

Hicro-Flo  Company
Garden Care  by
Farmingdale,  Ltd.
     10370-40
     10370-116
     10370-144
     10370-145

     11037-7

     11611-4

     19713-214
     19713-215


     34704-1
COMPANY

Thompson-Hayward
Chemical Co.

Velsicol Chemical
Corporation
EPA REGISTRATION NO
                          148-964
                          876-101
                          876-85
                          876-233
                          876-308
                          876-309
                          876-310
                                             3, 28/88
                                             3.. 2 b S S
                                             3/23.'68
                                             3/ 28,53

                                             4/27/S7

                                             7/17/87

                                             3/24, SS
                                             3/24/33
                                              4/27/8"
40831-5
40831-24
. 44215-7
44215-20
50383-20
50383-29
50415-27
51036-30
51036-31
53127-1
53127-10
PJTOT'AC/HT.O'R CANC^T-T.J
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
                                             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 Coir.pany
Griffin Corporation

Triangle Che~ical Cc.

Terninix Division of
Cook Industries, Inc.

Stepl'.enson Chemical
Company Incorporate


Roiv:ood Chemical, Inc.

Red ".ving Chemical
Ccrpar.y
7-.r'"nem Corporaticr.

Forshaw 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
3/19/8 8
7/01/87

7/01/87

5/14/87


4/21/87
3/22/88
3/22/88

 7/08/63
6/07/84

3/17/88

3/18/88
3/18/88
3/18/88

5/08/87


5/12/87

4/27/87

-------
                         APPENDIX  D
                       CifLQ.R D7j,Tv:_siis rcr;.? ION s
Yar.  Waters  &  Rogers, Inc.
•PA_B ^LLSJTRTVLLQN.

    550-106
    550-107
Chapr-.an Chemical
Company                       1022-502

Vaccinol Cherr.ical  Company
Incorported                   1353-4

AJ-r.^C Chemical Corporation   5481-223
                              5461-226
                              5481-50
                              5481-315
                                                   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
Corporation

'Black Leaf  Products
Corr.pany
Southern  Kill  Cree):
Frod'jcts  Cor.pany
Dettlei3ach Pesticide
Corporation
Mystic  Cherr.ical Products
                              5797-88
                              5837-67
                              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
                              6754-40
                              6754-64

                              36272-3
                          7/15/37
                         7/16/87
                         7/16/67

                         10/21/87
                         7/15/87
                         7/15/87
                         7/15/87
                         7/15/87
                         7/15/87
                         7/15/87
                         7/15/87
                         7/15/87
                         7/15/87
                         7/15/87
                         7/15/87

                         7/15/87
 COMPANY

 Southern Mill Creek
 Products Company
 Dettleirach Pesticide
 Corporat ion
                      REPTACHLOR SUSPDJSIONS

                    EPA REGISTRATION NO.
                         6720-279
                         6754-5
                         6754-40
                         6754-54
                         6754-64
                         EFFECTIVE DATE
                         7/12/87
                         7/15/87
                         7/15/87
                         7/15/87
                         7/15/87

-------
P»9«  Ic.     \   -
01/06/88         I
        STOP SILK ISS:JD AS
COWAIT
         of Products Containing
       ^rdane  and Heptachlor
       : ci  s»:::c» 3ic)(2i(i) -----   -
      .  «:«
??A •••:. i   PSO:CCT i  CEHKAL
ss ISSCED UTTDATE ?.•;;:•:* ."A.:
AKVAC  CHEMICAL C05P.          54bl  11}
4100 KAST HASEIICTOI BLVD
LOS ASC'LES    Ci  9fi02J

AHVAC  CHMIC1L COBP.          5481  226
4100 EAST WSEIKTOH 5LVJ
LOS MGEL!S    CA  SOC23

UVAC  COUCH COEP.          54S1  JlS
4100 IAS? MASBISGTOI IlVD    ~
LOS AJGELES    CA  90023

AHVAC  CHEMICAL COEP.          5461  50
4100 EAST MASEDtfOI !l-7?
LOS UGELES    CA  9002)

A! C2JSICM COt?.             7122  121
i5i< ELEvari r
KI?SROSTI     0!  4Si62

Al CE!*.ICAL COSP.             7122  3
1514 ELIV!1!H ST
POBTSXODTB     OB 45662

A3 CS!>ICAL COBP.             7122  34-
1514 EL!VEIT! ST      •
FCBTSROOTE     OB (SC62

B16CWPU!          ~    1612  «
1953? RAIBA!! M BOX 20372
DALLAS   -- TI 75220-

BUCI LBAf PtOWCT! CO.       588?  127
(67 I STATE ST
OCII         IL (0120

BUCI UAT HODOCTS CO.       58«?  67
667 I «m ST
DCIl ------    IIM12J
            •
BOIVII CUSICAI CO.,  IIC.     4    274
2 MU AH.          ,  .
lotmui     n 13495^.

BOHHECH2HICALCO.,  IIC,     4    275
2 nn An.
TOIKVILLE     I! 13495

B09DIE CBE3ICAL CO.,  »C.      4     ^10
2 Ol AV£.
10-tlVILLE     IT H495
           CHLOEOADE
           CHLORDASE
           ML08DM!
           CSWRMHE
           CCCSDWS
           CIUBNI!
           CIWIW!?
           C1LOBDAIE
           CflLOSDWE
           CliOSDAJ!
            cfiLos:>A$£
                                                    C1/06/8B    /  /   09     CA
                                                     01/06/IS   /  /    OS     CA
                                                     01/06/88   /  /   09     CA
                                                     01/06/U    /  /   09    CA
                                                     01/06/81    /  /   05     OE
                                                     81/06/91    /  / - 05    OE
                                                     Ql/Ob/81'    ;  /   05    05
                                                     ll/K/N    /   /   06    TI
                                                     01/06/18    /  /   05     II
                                                     01/06/88    /  /   05     i:
                                                     01/06/88    /  /   02     5
                                                     91/06/88    /  '   U2   :  S
                                                      01/06/88    /   /

-------
Paa* lo.     2
         STOP SALES ISSUED AS TBE RESIL7 OS SECTIOI  3(e)(2)i3l
                        FMS::*? ISSUED WE-  F:F?.A

                               EPA £••;.!   ?F::U:T 4  •J-EKICAL
90*1 !E C3MICAL CO.. IIC.
i «;.'F.L AVE.
IjyviLLE      5: lJ4i5
                               4     287
                                           CELOsDASE
3C!«::£ CHEMICAL ;.'C.. IS!.      »     9*
* •:?.: AV-.                                -
!:?r::LLE      SY 1-495

BON: IE :=.2«icAL co., IK.      4     ill
. »:?.Z ivi.                                CSLOP.DASE
?:r.-'VILL2      NJ i<495

•lAiOLISli CEiRICftL COS?.        5"?7  86
t-.:. KX '(                                CSMP.DASE
BILS05         SC 2?Sy.<

 ••i.:««: •:.-:••::?.: •:•:.           i;/<  50^
sC; »:'t                                   C-DEDAS:
!•?•.?::?        ?«  WiC?

COA5TA1 CHESI'^AI CO?.?.         5549  41
r.v. KJ KH                               CiiLOSDAIlE
C-riiSV.llE     NC :/S)4

•: •?.> 3£i: :--*::A:  co.         i;iu? /
?-.•:. ::x 41':                               CH:O?.:ASE
«c;;oit         N? t'oo:

CO-N SILT CEERICiL  CO.         10107 8
?.•:. s-JX- 4iii                               CEI05DA.NE
«:::ox         SE 69oa

CBE-O-TOX CHESIC4L  PSOD.  CO.   1066  29
BOX 12598                                  CELORDANE
«E«HIS        N J8112

CS2-0-TOI CmiCAL  PSOD.  CO.   1966  29
BOX 12598                                  5EPTACELOB
«S«?E!S        Tl 38112

DETTE: BACH PESTICIDE CORP.    6754  n
P.O. BOX 9986                              CSLORSM!
ATIASTA        GA 30319

DiTTEl SACE PESTICIDE CORP.    6754  40
r.C. 20X 99»t                              CELORDANE
ATLASTA        GA  3031?
DETTEL  EACH  PESTICIDi  CORP.     e7!.<   40
P.O.  -OX 998*
AITANTA        GA  30319
02     NY
                                                                                         Ui/3b/8»     /   /    C4
                                                                                         C1/G5/88    /   /    07
                                                                                         '.':.'05/88    /  /   04
                                                                                                                  SY
                                                                                         91/06/58    '   '    02     BY
                                                                                                     /   .'    64     TS
                                                                                         Oi/Ofc/88    /   /    04      SC
                                                                                         0!/Jt/98    /  /    C7      SE
                                                                                         01/06/88    /  /   04     TS
                                                                                         01/06/88    /  /   C4     TK
                                                                                         01/06/88    /  /   C4     GA
                                                                                          0:'06/85     '   /   -4
                                           SEPTACELOF.

-------
P«» lo.     3
01'06/8I
         STOP SALES ISSUE'.' AS  TH!  8ESILT 05 SSCTIOI 3«OUMB)
                     ?:SPEISIOIIS ISS«: W2EE PIFSA

TC'PAIIV                        ErA REG.I   PROD9CT 4 CEERICAL
                                                                                        cc 'JQI'.JD *'?r>>i"j iSi.'fii <•»*:
                                                                                        ?« ••a****/ y*..*n*. IV.J.VP ?,n.M
DETTEl SAC'.! PESTICIDE COB?.     6754   5
P.O. -OX ?9d5                             8SPTW5LOR
                                                                                                           14     «]A
?TT?E"  EAC? PSSTIIIDi COP.P.
I'.O. rOl r96
ATLAS:*        '.;A K-iie
                               '.754   54
DETTEL BACH PESTICIDE CORF.     6754   54

ALTANTA        GA }OM9
lETTEL ?ACE PESTICIDE 'CORP.
P.O. SOX 99ft
ATLASTA        GA 30319
                               6754   64
                                          CELC-8DASE
                                           EEPTACH108
                                          CSLOF.DW!
:•?*•: IVr. ?ESTICIDE CCSP.     6*54   64

ALTASTA        CA iv.J19



AT1ASTA        ^A J3J19
DE7TELEACK CSESICALS C05P.
j*7e AFPI: VALLEK 8D.
ATLASTA        GA JCJ19

lilvl IS^ST-IZS
;45o U. i2!>T:; ST.
T;:?.?.ASCS       CA 9t5ti

DEKL ISI'CSTEIES
i45i N. 228TH ST.
TCiicASCE       CA 9C501

EIOL IIDCSTBIES
145t I. 22STB IT.
TOERAJCE       Ci 905C1

DEXCL ISDDSTSIES
1450 «. 228:5 ST.
TCP1A5CE       CA 9C50:

DSEIEL CaiSICAL COSPSSY
 4¥? PSSSSILASIA ST. rOJ S306
               TN J8if9
OREI'L CHHICIL OOf.PA^
i4U" J-SSiviASIA ST. 50! 9?0fc
                               14^1   2J
                               i?2   132
                               192   153
                               192   42
                               192   43
                               • « 4. « •> • *
                               .?7ij 2i4
                               19713 215
                                           CELCSW.SE
                                           CELOP.DASE
                                           CHLC5DASE
                                           CELOEDA5E
                                           CiMSDASB
                                           CBLOBDABE
                                           CHIC'RDWE
                                           CKMBDME
Ol/Ob/88    /   /    '4
                                                                                        fll/Ofc/88    i   I   v*     •:•»
01/56/88    /   /    C4      GA
                                                                                        01/06/88    /  /   04     '.'A
                                                                                        91/06/93    /  '   04     '.-A
Oi/S6/i!3    '
»i/05/88
                          CA
01 '06/88    /  '    '.'*     '!.*
ui/fi6/b8    '  /   09     •:=
01/06/98    /  /   :S     CA
 51/06/98    /  /   C4

-------
                     !?«:•:  AS  T«£  «S;IT  rs  5-:r;oi
                     5?s?E«siO!if ISSUE;-   S:E?  F:-?A
FA115 •.•••"ICr.S. IRC.
?-.•:. sol 2>45
                                           CHASMS'
:A:I? :E£»:ciis. :sc.           w.:  5
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••:=:•? :::•«:•;*.: i S-SVICE  isc.   iujjc  11*
i'-'r ?A5A:-S.i. SLVl'.
r.».5A:'-S?,       TX "502
•'.••I? CHi«:CAL * SERVICE  ISC.   1037:'  .44
i?.* FASAlESi Biv:-.
PASADMA       T! 775C2

?0?.:s  "f-r.ICAl 4 SERVICE  ISC.   ;C:T'  .4;
iTj? PASAI-ESS Sl-v..
       A       TX
?"?.I'S  ?-:*ICAl  i  SERVICE  ISC.   lO?/(!  4fl
i":^ PASADENA BYv'I.
?A?AIEVA        T!  77?Oi
 •'.-.::.&  :EE»::A:  cc.
ir: STATE STREET
      S CHiKCIAl CO.
*5'. STATE STREET
CHARLOTTE      5C  282C8

FCRSEA'rf CH!?.CIAL CO.
t-SO STATE STREET
CF.ASLO?!'      SC  2829*
FOP.SEAH cmiCIl  CO.
t» STATE 8!IE!T
CHAHWTTE      1C 28208

POaSEM CHttZCAL  CO.
t5i STATS STHEET
:HA=VTTE      sc 28:08

FC:.S?.AW C-'MICAl  TO.
t:;. STATE STP.EET
THA'LCTTE      SC 2820?

?o?.sHAVi •:-:*:-:AL  CT.
•f. 5TATE STSEE"
•:HA?I:TT»      sc 292(18
                                7243  31
                                "24:  «9
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                                7234  101
                                "224  5
                                7214  o
                                            EEPiACElCS
                                            5EPTACSL08
                                            C3LO?.:»K
                                            CELOSDASi
                                            CHLCSDA5E
                                            CHL03DAS!
                                                                                          il.vt(t;     '   '    01      *."
                                                                                          oi/os.'ss    /  •    •:.     ?.:
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                                                                                          •:;0*/st    /   /   06     Tl'
                                                                                          Cl/06/88    /  /   06     TX
                                                                                          Oi/0t/«b    /  /   C4
01/06/38    /  /   C4     SC
01/06/88    /  .'   C4     SC
01/06/38    /  ••   C4     S-:
01/06/88    /  /   04     ST
Gl/Cr^K    /  /   U     S-T

-------
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                                            CEl-OSDAS:
5"i«i»S SILL CSEiS  P5CD.  CO.  STid  361
P.C. 301 1096 5514 K  5tTr                   CEIO-DASE
TA«A          PL  J3601
SC'JTEE?* 5I1-L •.-••>  PP.OD.  CO.   6720
P.;. B:K ic9t ?5i4  s :t::;
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               -<:?rv  53"
                                ^«.   45
• .. • ;".X ^ '44
V.ZT'T

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         ST.!- SALE:  ISS'EI •? "-.: ••51"  '• fi.TI.H






-.:-. :i! "3*4                               ::-:i:"As-
*"." '          !'  J«.»! "

c»:::.vj;~ij  •••..•:«   '••    "V".     i--1  '••







STEPEiSSCS  CHE."..  CO.,  ISC.     4c:"  •:
BOX g/lc:                                   CKLlr.LANE
COLLEGE PAS*    GA JOJ31

5TEPEE!i5:S  Inl?.  TO..  ISC.     4!;:1  :c
50i' vl::                                   HEPTAC'r'.C-
CCLLE'T-E PART    GA .  :J:



'MLLEGE -Ar.'    GA :..'.-:

57NS1LAS?  CO?.?-I£ATirS          -4.4  :



VACCISCL CHEMICAL CO., ISC.    1253  4
1:2S S-I?.:;  Hi:-HLA5:'                         lEL'Ir.IASE
KE'-EIi         TS ::.;S

VAS WATERS  &  ROGERS             555   ..-
225t JDNCTIOS AVES3E                       CHLOSL'ASE
SAS JOSE        CA 95151

VAS KATEES  &  ROGERS             550   I'!'
2256 JWCTIOS AV!S:E                       CKLTFL?.?::
SAS JOS!        CA 95131

M ?. GRACE  & COHPAHK             2124  H^
P.O.30! 217 100 P RAW ST.                 •T.OP.I'AS-
KEB-'EIS         TS J8''0'

WILSON LABS.  ISC.

???ISG:ALE      c: -t-v?

VillS-TS LAES,  1ST.

-------
                  Federal Register  /  Vol.  5U.  No. 212  /  Tuesday. November  3.  1HH~ /
                                                                       4214:5
h"rtil«p::uliTS buiMiii;: at 401 V S
SU . W.iKhinsinn. L)C.
  The purpose of the mculiriR is lo
r< view th<> fifjil dr;«fl of the Risk.
Kciii.i:iion Croup's strali:K> on
i-ru irr.nn;i-;i'.;il risk reduction.
  Tin. mcetmy is open lo the public. Any
nicn-.her of thf public wishing to attend.
nuke brief or,il coinments. or submit
written cornrr.L-nts to the Croup should
notify Mrs. Kjthleen Conway. Executive
Secretary, or Mrs. Dorothy Clark. Staff
Secretary. (A101-F) Science Advisory
Board, by the close.- of business on
Friday. November 20. 7987. The
telephone number is (202) 382-2552
Terry F. Yosie.
Dirc'j'.or. Science Advisory Bi>arJ.
  D.itc: October 23. 19".
|rR Doc. 87-23383 Fjlod 11-2-87; 8 45 nm]
BIUJNC coot esco-so-M
IFPL-32B6-11

Science Advisory Board Research
Strategy Subcommittee Sources,
Transport and Fate Group; Open
Meeting

  Under Pub. L 92-463. notice is hereby
Riven that the Sources. Transport and
Fjtc Subproup of the Science Advisory
Conrd's Resciirch Strutepies
Subcommittee will met I from 9:00 a.m.
to 4:00 p.m. on December 8lh 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 development
of research strategies needed to enhance
the Agency's ability lo 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-madia basis.
  The meeting n 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 Foellmcr by December 4.
1907.
  Date: October 28.1987.
Terry F.Yoi IB.
Director. Science Advisory Board.
|FR Doc. 87-25391 Filed 11-2-67; 8:45 am]
BIUJNO COM IMO-SO-N
IOPP-60011; FRL-3286-61

Chlordane and Heptachlor
Termiticides; Cancellation Order

AGENCY: Knvironir.c-ni;il Proi-ciion
Aponcy (EPA).
ACTION: Order.
SUMMARY: On October 1.1907. EPA
issued an Order accepting the voluntary
cancellation of certain chlorcane and
heptachlor Icrmiticide registrations held
by Velsicol Chemical  Corporation, and
limiting the use of existing stocks of
Velsicol's chlordane and heptachlor
terrr.iticide 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 30.1907. From December 1.
19G7 until April 15.1968. 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 Apnl 15.1988.
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.
SUPPLfMENTARY 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
termiticide 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 sale or distribution by Velsicol of
its affected chlordane and heptachlor
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 Velsicol's control on or before
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 to a federal court
action.
  Tin- ( .virl in (JIM' ,|, Imp r\|>r--s-i .'.
i:mii."rn th.it Ki'.', ;-.:^iu H.IM'
\:ni)tTi.ist::r.:!fr! tin- .11:. >un: >•! rx:-  ;:j
.situ.)>« (if llul ii«if .j;" iht- r\isi;r;: :'.«. HH
might continue :i.iJv-imilrly W'm'.r I'.i'A
tonlmjcs lo l)oiii:vc '.h.il Us rst.m.i'i:
v.;is an ucciir.iti: one. Li'A nnJ Vri.sicui
       to supplement  the August 11 ih
         t in onier to  alli-vuite thi;
court's concerns.
  Under the terms of the Sjpplomt'nt.
r.itifiiMJ on October 1.  1967. Velsicoi's
chlnrdnnc and hept.iclilor turmiliciiic
registrations were split into product
rcytstrdtions cor.tuir:ir.g the dc-letciJ uses
and product registrations containing the
retained uses. Those registrations
containing the deleted uses were
voluntarily car.celnd.  EPA issued ,in
Order on October 1.1957. accepting tra
voluntary cancellation and plnr.ing a
two-tiered cap on the use  of existing
stocks of Velsicol's chlordane and
heptachlor termiticide products outside
of Velsicol's control on August 11.1907.
These stocks may be  sold, distributed
and used in any manner consistent with
their labeling until November 3U. 1987.
From December 1.19K7 until April 15.
1988. these stocks may be sold,
distributed and used only in accordance
with the specific directions for use
attached to the Ocluber 1st Order. No
use of existing stocks will be permitted
afler April 15.198fl.
  The text of the October 1st Order ar.d
the attached Directions for Use arc set
forth below:
  In the Mutter nf The Voluntary
Cancellation of Certain  Pesticide Prodjct
Registrations Held by the Velsicol Chcrr.Xdl
Corpora lion.

Order Accepting Voluntary' Cancellation
and Authorizing Use  of Existing Slocks
With Limitations

   As explained more fully below, this
order accepts the voluntary cancellation
of  the registrations of certain pesticide
products registered by the Velsicol
Chemical Corporation ("Velsicol") and
imposes limitations on the continued
sale, distribution, and use of existing
stocks of such products. This Order is
issued pursuant to the authority in
 section 6(a)(l) of the  Federal Insecticide.
 Fungicide and Rodenticide Act.
   On August 11.1987. Velsicol and EPA
 entered into an agreement affecting
 Velsicol's registrations of chlordane and
 heptachlor products.  The agreement is
 memorialized in a Memorandum of   :
 Understanding and accompunying
 Conditions of Registration and
 Monitoring Protocol.  Under the terms of
 the August 11 agreement. Velsicoi
 classified the following uses of its end-

-------
                            Register /  Vol. 52.  No. J12  / Tiit-sd.iy. \n\ri:il..T  3. 1007
us.- 'i T.,:'.. :iic pr-id.:..!s ;iS "drie'rd
1.1,'
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n. .:. •: ;. fr,m. vvi'h.r. .1 «irvic.ture
fr- .  •• :i!i-;j !;v hurnrtris ('structure"):
   h  I'us! turstr-.iction jjppiu:nl:on of
rr. ;•  r:j! from outbid'.1 H structure lo
ir.s.Jc or underneath a structure:
   c The use of pressure roddina for
post-construction application of material
in .-i base~]~nt-type or crawl-space type
slri.'durr:
  ri.  Pre- or post-ccns:rjctior. treatment
of :hc urea underneath crawi-space and
post  and pier type structures:
  e. Tren'rr.cnt of voids end spaces in
masonry or block walls or areas behind
vcpocrs:
  f. Applications by non-certified
  » Soil-injection pressure redding at
prt??surps greater than 25 psi.
  Thr agreement further classified the
following uses 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
urv-.-.clo'si'd slabs, and applying material
lu :lii' SG-.I without pressure (e.s;.. flow or
gr.ivity food).
  b Applicat:ons by the excavation
tr-chr.iijue to the cxte:!ur of any
^iructt'.iro (i.e.. hy rcrr."-. :n.s soil next to
i~r foundation, placing  on a tarp.
trc..!:nj; with tcrm:tic:ide. arcJ placing
back :r. trench after soil drips):
  c Prc-rorstructior. loiv-prcssure
[n-.ixim'irr. 25 psi] vertical roddmp (with
the app': ration rod equipped with a
pressure control device to prevent
higher pressures) of the perimeter
outside any structure:
  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
anil pier type structures:
  f . Post-construction coarse spray
surface treatment (maximum 50  psi) and
low-pressure (maximum 25 psi) vertical
rodding (with the application rod
equipped with a pressure control device
to prevent  higher pressures) under the
slab of slab type structures.
  The agreement classified one  use. the
protection  of underground cables, as an
"unaffected use".
  In addition to this classification of the
uses of Velsicol's termitiride products.
the agreement included, inter olio, the
following provisions:
   • The retained uses were converted to
restricted uses as provided for in
sections 3(d) and 4 of FIFRA:
   • The registrations of the retained
usrs were  amended lo conditional
registrations, with no sale or distribution
by VrUico! ;i!!:m«;d until cort.nn
conditions set forth in the Conu.iinns uf
Registration jre net.
  • Nn frr'.hrr <;;i!c ;:r di'.lr.'.jiiti-v; In
Velsicol of L-nd-usi; products l.i!» l.-d foi
deleted usi.-s W.TS uiiuwrd.
  • Velsicol amended the label of 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 us a subterranenn
termiticide.
  The agreement became effective
immediately on August 11.1987. 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 heptachlor termiticides
(or approximately 110.COO gallons) was
in the hands of applicators and
distributors as of August llth.
  Portions of the agreement between
Velsicol and EPA have been cholienped
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 that 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 to
believe that its earlier estimate of
existing stock was an accurate one.  EFA
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 concern. 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,
VeUicol's chloradane termiticide
registrations have been split in'.o
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  with
their labeling un'.il November 30,1907.
Ironi Dcffnili.T 1. 10P.- until April 15.
VUill. thesr- stocks :::;iy lie so!;).
riistnluitrd. and i...cd only in iirci : J.inci-
with il:c com):!-.'!!-..-, rf use prr-sn;  ^-J in
Appendix A u! this Onli-r. No use will
be permitted after April 15.  19U8.
  FPA believes the lurms of this
Supplement will iillow for an orderly
and efficient phase-out of chloridane
use. The Supplement provides sufficient
time 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 stocks if EPA was
substantially incorrect in its estimate or
if individuals possess large stockpiles.
EPA favors a two-tiered approach
because it encourap"c the 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 aftjr November 30.
19C7.
  EPA finds '.hat implsmentation 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 w:'.h  the purposes
of the Act. The limitations contained in
this Order will not permit any greater
use of stocks than that wh 'h tr,e
Agency has already founu 10 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 amount • ' stocks in
the possession of applicators and
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 15.1908). 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  mdnor
exposures: and they will allow for the
certification of applicators (use of Ilie

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                  Federal  Register / Vol  S2. No.  212 / Tui""! ••>-._ Noypmbi-r 3.  1WT / Notices
                                                                      •J2N7
r\ siinj? stocks will be « restricted uso
H* set Ir.nh in FIFRA sections 3!d) and -J
.if'-r November 30. 1987). Finally. Ihe
d.iits ri>ncct information provided to
KI'A thiii. even though, there may well
h.i\c \ii; n only 110.000 gallons of
cvis'ir.e Mucks in the hands of
up;;hcjiors and distributors on August
11 1907. the rate of chlordane use has
decreased sinre thdt date, and will of
necessity decrease even further after
Nuvembt-r 30.1907 when certain uses
will no longer be permitted.
  Based on all the foregoing, pursuant to
Fire A section 6(o)(l):
  1. The following registrations of
Velsicol's End Use Products are hereby
cancelled:
  A. The F.nd Use Product described in
Section II.A.2 of the  attached
Supplement (that product currently
assigned EPA Registration Number 876-
233 bearing all uses  of Cold 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 Gold Crest C-100
o'hor than the reta./ied uses).
  C. The End Use Product described in
Section 11.C.2 of the  attached
Supplement (tha! product currently
assigned EPA Registration Number 876-
104 bearing all uses  of Chlordane 8EC
Termite other than the retained uses).
  D. Gold Crest C-50 (EPA Reg.  No. 876-
G5).
  E. Cold Crest H-60 (EPA Reg.  No. 876-
85).
  F. California SLN  for crawlspace
perimeter spray (Termide) (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 11.1967
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 product* 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 uf.ed on or before April 15.1980
must be disposed of in accordance with
applicable federal, state and local laws.
  It is sc ordered this 1st ri.iy of
OiMnl.cr. 1987.
DIME!.is U Campt.
D.'rci i,jr. O;Y.ce of Fi-slit irit- rr^ni:im.
Appendix I—Voluntarily Cancelled
Subterranean Termite Control Products
Directions for Use Between December 1.
1987. and April 15.1986
Restricted use Pesticide
For Retail Sale to and use Only by
Certified Applicators or Persons Under
Their Direct Supervision
  It is a violation of Federal law to use
this product in a manner inconsistent
with these Directions. This product may
not be used against any pests not named
in these Directions- Apply only to
establish subsurface termite control
barriers specified in these Directions.
  Contamination of public and private
water supplies must be avoided by
following these precautions: Use anti-
backflow equipment or procedures to
prevent siphonage  of pesticide back into
water supplies. Do not treat soil beneath
structures that contain cisterns or wells.
Do not treat soil that is water saturated
or frozen. Consult state and local
specifications for recommended
distances of treatment areas from wells.
and refer to Federal Housing
Administration Specifications on new
construction for further guidance.
Preconstruction Subterranean Ternite
Treatment
  Effective preconsiruction
subterranean termite control 'equires
the establishment of an unbroken
vertical and/or horizontal chemical
barrier between wood in the structure
and the potential cr existing termite
colonies in the soil. To  meet FHA
termite  proofing requirements, follow
the latest edition of the Housing and
Urban Development (HUD) Minimum
Property Standards.
Dilution Instructions for Gold Crest
Termide
  Use a .75% water emulsion for
subterranean termites other than
Coptotermes spp. Mix 1 gallon of Gold
Crest Termide in 99 gallons of water to
produce a 0.75% water  emulsion. Use a
0.75-1.5% water emulsion for
Coptotermes spp. where necessary. Mix
1-2 gallons of Gold Crest Termide in 99
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
Coptotermes spp. Mix 1 gallon of
product in 95 gallons of water to
produces 1a  w •i!cr eniulsi'T-.  !'>r .1 1-
2 o water emulsion for C'/'•''\vni:.-> >pp
whrrc nprrss.iry  Mi\ 1-J c..'.i->r.s ,if
product in 93 gallons nf water to
produce a 1-2'v water eniul>.,m.

Dilution Instructions for GoK! Crrst II-
00
  Use a .5% water emulsion fur
subterranean termites other tlinn
Coptotermes spp. Mix 1 gallon of
product in 59 gallons of water to
produce a .5% water emulsion. Use a ln-
water emulsion for Coptoti'rmt'K spp.
where necessary. Mix 2 gallons ot
product in 59 gallons of water to
produce a ic-i water emulsion.

Dilution Instructions for Gold Crost C-5U

  Use a 1% w .itur emulsior. 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 to soil beneath
structures which will contain subslab or
intra-slab 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.g.. bath
 traps, inside surfaces of concrete or
block walls above the leve! of the slab).
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 T gallon per
 10 square feet to  fill dirt. If fill is  washed
 gravel or other coarse material, apply at
 1 '/r gallons per 10 square fret.

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             UNITED STATES ENVIRONMENTAi

                         WASHINGTON. D.t
                                                           OFFICE OF
                                                   PESTICIDES AND 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  chlordimef orm.
 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
Pand  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 Agency's position.

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