I ,

    1.
          I     UNITED STATES ENVIRONMENTAL PROTECTION AGE.NCV

    v>     ...                 WASHINGTON. 3.C. 20460
    (
                               22"SS3

                                                            t AMD TOXIC XUBCTAMCCS
^SUBJECT:  Compliance/Enforcement Strategy far the Federal
';'^           Insecticide, Fungicide, and Rodenticiie Act  (F IF 3 A )

 .TO:       Al vi n L . Aim
            Deputy Administrator
KV
       Attached  is  the Comp1iance/Enforcenent Strategy for the
,, Federal  Insecticide, Fungicide, and Sodenticide Act.  The
^strategy was  developed by a  woric group composed of Headquarters,
  Regional,  and  State pesticides personnel,  and reflects tne views
  of  al1  parti cipants.

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

       The strategy is based  on trie assumption that adequate resources
  would  be available to support a balanced crediale program.  Because
  of  actual  resource constraints, however, our primary goals through
  FY85  are 1)  to maintain th-e  present monitoring/compliance level in
  States  with  cooperative enforcement agreements, 2) to negotiate
  cooperative  agreements with  the remaining  States, 3) to refine
  the  program  management and  oversight activities and 4) to further
  develop  and  expand the data  audit/Good Laboratory Practices inspection
  program.  To  meet these goals, we will perform the following activities
  through  FY8S:

  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 snould 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
  55 Practices  (GLP's) Inspections.
   o>
   o                        HEADQUARTERS LIBRARY
                            ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C. 20460

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                               - 2 -
o  Finalize enforcement response policy far data auii t s.'GL?  insoe
   tions.

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.

0  Provide technical and legal  support to States.

o  Provide training for State Inspectors and chemists.

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

o  Promulgate a final FIFRA 4  rule requiring dealers to  keep
   records of their restricted  use pesticide sales and  clarifying
   where commercial applicators must Veep 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
   1n 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 Hanagement System
with projected completion schedules.  Due to anticipated  resource
limitations, we will be unable  to undertake the following activities
through FY85:

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

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

o  Support all ruleaaking by the Office of Pesticide Programs.

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

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                               - 3  -

o  Update the Pesticides Inspection  Manual.

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

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

     Please let me know 1f you have  questions  or  would  liice  to  further
discuss our plans for implementing  the FIFRA  Strategy.
                                  Don R.  Clay"
                                  Acting  Assistant Administrator
                                    for Pesticides and
                                    Toxic Substances
Attachment

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Introduction                                           1
FIFRA Compliance Program Overview                      1
Previous Compl i ance/Enforcamerrt Strategies             3
Present State of Compliance                           12
Goals and Priorities                                  13
Plans for Achieving Program Goals                     15
  Compliance Monitoring Plan                          16
  Cowoliance Promotion Plan                           21
  Noncomp1iance Response ?1an                         23
  Heaaquarters/^egicnal Coordination                  2?
  Federal/State Rel ati onsr;i p                          29
  Cosperativa Certification ani "ra: " .--
    Program              .                             31
  Cross i5rogram Elernencs                              2-r
Program Evaluation                                    S6
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
              Inspectioos
  Table IV -  Federal  Pesticide Enforcement Actions

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                 FIF3A Comoliance/nforcament
I nt raauct * on
         and ma:i-
         nsecti ci :
     Tills document contains EPA's strategy for acn-evi
taining compliance wltn tne requirements of the Faeral
Fungicide, an* Rodent i ci de Act (FIF3A) as a^enaed
regulations.  The document provides an overview of cne FIFRA ccm-
pl 1 ance/enforcemnt 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
comprehensive look at the program atid indicates
which should be taken to implement an effective
resource constraints, the actions which will be
to those indicated in the priorities for FY85.
strategy tak'es a
a numb-er of actions
program.  Based'on
taken are limited
 IF3A C jmp 1 ! a i ca J roc ran
Statu t o ry / 3 s c u 1 a t ary 3 ecu i r s m e n ~ 5
     FIFRA, as aienaea, currently hai a varis^y o .r .r.e-.-.
tect health and the environment from unreasonable risks
It contains the following requirements:
from
             pesti ci des
o Federal registration of pesticides.
o Submission of data to EPA by the registrant/applicant for registra-
  tion in support of registration, which shows that the product,
  when used as directed will not injure man, animals, crops, or
  the environment and will not result in illegal residues on food
  OP feed.
o Federal classification of pesticides for general  or restricted use.
o Specific labeling of pesticides, including the product's classifica-
  tion and proper use directions.
a Ctrllti Reststant Packaging if a product meets certain toxicity
  criteria and Its labl allows for residential us.
o Submission of a Notice of Arrival for all importations of
  pesticides or-devices.
o Certain labeling for all exported pesticides a-nd notification of
  EPA when unregistered pesticides are exported.
o Establishment by EPA of residue tolerance levels for products
  used on a food or feed. crop.
o Experimental Use Penrtts (EUP's) for limited field testing prior
  to registration.
o FIFRA 18 Emergency Use Exemptions by the Administrator upon
  applicition from a State if certain criteria are met.

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                               - 2 -
or a a a i t: o n a
special  1o c a
of
            *n
                                                 use:
                                                 n a a ;
                                                 :cn
                                                 ,nce or oooi
                                                 ted
                                                 las
                                                 the
                    us
                   sif
                    di
3 pestle
i ed
rect
                        for
                         sup
s.?-ie-1 s
 f*



'des

er-
o FIF3A 2A(c) State registration
  pesticide witnin a Stata to
o Cancellation/suspension Dy ?*
  ao le adverse effects.
o 'ederal registration of pesticide or device pro'
0 Submisson of annual reports to E?A and maintena>
  records oy each registered estao1isnment
o EstaDlishment inspections.
o Certification and training for users of restrict
  by the States with plans or EPA.  (Pesticides c
  restricted use may only be applied by or under
  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 5!sentati on

     FIFRA was first enacted as the Federal Insecticide Art in 1.910.
Since then, 1t has undergone major revisions which have resulted in
changes in the compliance/enforcement program.

     Traditionally, primary responsioi1ity for enforcing trie reqatra
ne.its of FIFSA has resided with the r**r\\ government.  "*
"vow ver, Congress oavsd trie way to snift rso ons i o* \ i ty ~2 ~,
by amending FIFRA to provide for radars'; / St 2t a cocparst: v .:
governing pesticides enforcement and applicator training ana
fixation.  Congress furtner strengtnenea :ne reipons i o i". i ;y
States in the 1978 FIFRA amendments which establish the pres
that States, under certain circumstances,, shall have primary
sibility for bringing enforcement actions against violators
pesticide use requirements (primacy).
                                                             oer- i -

                                                            umpt i on
                                                             respon-
                                                            of
     Most States Mho 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)
wnlcti 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
1f it has adequate laws and procedures governing pesticide misuse as
required by 26(a).

     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 ?A; 2) rescission of primacy
If the Adninistrator drtem1ns that a State 1s not carrying out its
enforcement responsibility; and 3) action by EPA during emergency
condlti otis.

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     The 1972 a/Tiendnients to FIF3A require the cart i fi ~i".  :r  of
aps'Mcato'-s to apply or supervise tie application  o -  ~*z~~z*~*s
classified for restricted use.  Congress exaectaa  States  to  certify
applicators ana authorized funding support.  The State -cooarative
Extension Services were to oe utilized  for trie t r a: T  g  of pasti-
cice apolicators *itn EPA funding sjooort.

     As of October 1983, all but 4 States have funded  coooerative
enforcement agreements; all out 3 States have been  granted use
enforcement primacy; and all but 2 States have approved  certification
plans.  As ttvese 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 jomp1iance/ Enforcement Strategies

Pre-1 980 Program Reassessment	

General Enforcement of FIFRA
     While trie FIF3A an forcaine-t prSg.-im *as 'Dcatai  : i :.:= 'J-.:ts:
States Department of Agriculture (USDA), the enforcement o^ogram 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,
chemical deficiencies,  nonregistration.  There was no authority to
take enforcement action against improper use.  Criminal action was
The only available response against violators.

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

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                                .  4  -
                          .     .
                          -:-j" e^
      In  1374,  ?A  entered  into  pilot  cooperative  a :-2
 5  States.   Prior to  this  ti.Tie,  ine  States  ana  tna  Fa-i
 had  separata  programs  witn  little  interaction.  ~-*  "
 of the  cooperative program  *as  joint  an'orcanent  vt-  cortinuec
 Fedaral  prasenca in  those States with  agreements.

      The Feaeral enforcement  program  became  none  aecentral i 233  : -
 February 1375  when Headquarters announced  a  program  to  waive  con-
 currence for  routine civil  cases,  excluding  use cases.   3y  NovemDer
 1978, all Regions were  granted  1)  full  relaxation  of the requi rene.i
 for  Headquarters concurrence  in actions  related to stop  sales
 and  civil cases other  than  misuse  cases, and 2) partial  relaxation
 tj-f HeaTiquartars CDTrcuTTBnce tn t-h-e  enforcement of misuse cases.

      The 1978  amendments, under certain  circumstances,  gave primary
 responsibility for use  enforcement  (primacy) to States.   As mere
 State programs became  operational  under  cooperative  agreements
 and  received primacy,  Federal activities shifted to  enforcement
 programs in States without  cooperative agreements  and primacy,
 program oversight, training of State personnel, disinfectant/device
 testing, import/export  surveillance, and data audits.
     Suidan
annually.
activities
Guidance cto
i^clLidiic a
inspections
dppiicdtcr
inspections
workyears E
Percentages
regulatory
           ce for the cooperative agreement program was issued
           Until 1930, strategies emphasized a graauai shi
           related to product conpliince to t.tosa non : to<":
           cuments assignee! oa"cantagas to various acti/'t
           gricultural, noni^r'C'jl". ^rj" a?-: ?.;-; -lent "  .
           ; producer establishment, marketplace, import,
           recoruj \ nsp^ct i *cia> ; anu rascr.Cwcu a^c pejcici
           .  The percentages correlated to the amount of
           PA expected the States to spend on the various
            were assigned based on prior violation trends
           requirements.
                                                           r;  rrsm
                                                           .1:  usi
                                                          certified
                              total
                              activiti
                              and new
                                                                  es

Federal and State Certification and Training
     Prior to FY81 , the C i
of Pesticide Programs (OPP)

1980 Program Reassessment
T program was
Independently
                                          operated by the Office
                                          of the compliance program
     In June 1980. th.e pesticides compliance/enforcement program
was reassessed.  The resultant strategy document, "Reassessment of
the Federal/State Pesticides Enforcement Program", has guided the
Federal/State cooperative pesticides program in recent years.  The
document was the basis for major changes in the compliance/enforce-
ment program and contained the following goals and priorities:

o Improve management of all State and Federal pesticides enforcement
  program elements by: a) developing a priority setting system; and
  b) improving program evaluation through a better information
  retrieval system, uniform evaluation standards, pr1od1c
  evaluations, and appropriate program modifications.

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                                   ana acsq
                                 by:  a
                                                     1 0 ~
tnsure tnat eligisie States receive primacy
tne puolic.  This goal  *as to se achieved
interpretive rule on privacy standards; b) p-o^ulca ^  .
tion governing hearings for r-sciss'on of pr-i^acy; c)  i s s
guidance on incentives  and sanctions to encourage adequate
                                                          s ! y 2 ~ ~ t 2 C t
                                                         ,7    r a -'
                                                               g
                                                             itate
  orograms; and d'i evaluating a1.! State use enforcement programs.

o Ensure effective compliance monitoring and enforcement  activities
  by  assessing tr-aitn'Tig programs and revising training rcacerials.

o Ensure adequacy of the certification and training program by: a)
  reviewing State plans and certi f i.caion and recerti f i cat i on proce-
  dures and Extension Service program materials; and b) revising
  training materials as appropriate.
  Increase public understanding
  enforcement activities.  This
  materials and sponsoring training activities
  minimize pesticide risks and to help persons
  in documenting misuse violations.

Implementation of Strategies	
                     of and participation in pesticides
                     goal  was to be achieved by preparing
                                    desi gned
                                    exposed i
                                                       :o help users
                                                      o pesticides
stra
     The Compliance Monitoring S:aff designed and began i-no'amen:i
    tegie
strat 2gi 2S
         for
    achie
f 3! 1 c-"S :
                      ng t-s^s* ;c
   r o v e i-i ana jam e n t
Priority Setting.  The largest portion of the Agency's pesticides
compliance and enforcement resources are directed at pesticide
product and use activities.  These resources are used primarily by
the States through the cooperative agreement program but also by
the Regions tn conducting FIFRA compliance programs in Colorado,
Nebraska, tfyomin-g, and Ohio and handling referrals from the States.

     In the past., EPA Headquarters directed that resources in both
the State and Federal programs be allocated to compliance activities
based solely on general national priorities.  As a result of the
reassessment 1n 1980, EPA required both the States and the Agency's
compliance program to identify priority pesticide problems and to
allocate resources to activities which most effectively deal with
these problems.  To assist the States in this activity, the Compliance
Monitoring Staff (CMS), in conjunction with the Office of Planning
and Resource Management (OPRM), developed a flexible priority setting
model designed to ensure that resources in both Federal and State
FIFRA compliance programs would be applied in a manner which would
most effectively address major pesticide use problems arising in
individual States.  This model was Included in the FY82 guidance for
Cooperative Enforcement Agreements and was referenced in the Guidance
for f
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      Application  of  the  model  results  in  four products:

 1.   A  list  sf  pesticide  use  problems  ran*ad by tnei   -*2t've
     ccatriaution  to  fiaru froa  pesticide use/misuse  iic*:ar:ts.

 2.   A- listing  of  pesticides  .-aniced  by  their relative  zznz ri ajt ^ :~
     to  ham  from  pesticide use/misuse  incidents.

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

 4.   An  allocation of program resources that maximizes  potential
     prosram  effectiveness by considering  1) the relative priority
     of  tne 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
 "Y34 guidance.  Because  narm is li c c o >"i \ t J *  ii 3 priori cy ~> j a  * '< y n  o < >i  c i 
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0

3
3
0

0
  ?3Sti;1da estas 1 i s^ent ragistrati an and productsn -
  "nspections ano sampling
   ase nanagenent
   rants information
   on tract inspections

After a feasibility study in 1979, a system design
initiates in 19j,  3<*v! apment and implementation
early 1981, and by October 1931 FATES was operational.
system installation and user training was accomplished
and system validation was completed in 1983.  However,
data base system updates and enhancements are required
data for new program activities such as the FIFRA Child
Packaging and Label Improvement programs, and to provide
sive information for the Administrator's Management Accountability
System.  Additional AOP 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.
                                                   pnasa was
                                                   was begun in
                                                        Regi onal
                                                       in 1932,
                                                       major FATES
                                                       to maintain
                                                        Resistant
Uni form Standards
                    In 1982, an evaluation protocol was included in
the FY83 cooperative agreement guidance.  The protocol was developed
1) to ensure that all State cooperative enforcement and C 4 T programs
would oe evaluated, annually by tha Regions according to u.Tlfarn stan-
dards; and 2) to en-sure that appropriate pesticide usa problems woul 1
is addressed ii State pesticids appHcatO'* tra'niig and cer-i f 1 cat: o*
materials.  This ,: r 3 1 o c c 1  * 3 3 aeveloDed for a 5 a ii ~ Y 3 3 s.:: i ,v
modified as appropriate based on experience with
                                                   "Y33 z::
                                                     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 th program an
element of flexibility which allows resources to be allocated each
year to those areas where they are most needed and can be aost
effectively used.

Primacy

     At the request of the States, EPA developed a rule Interpreting
several key provisions in 25 and 27 of FIFRA.  The Interpretive
Rule promulgated on January 5, 1933 addressed 1) when a State will
be deemed to have adequate pesticide use laws and enforcement proce-
dures, 2) criteria used by EPA to determine whether a State 1s
adequately carrying out primacy, 3) EPA procedures for referring
misuse allegations to t-he 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* the Agency determines
whether a State should be granted primacy or whether its use program
Is adequate based on a review of the State's entire program rather
than a case by case review.  EPA. evaluates a State's primacy program
during the end of the year grant review for those States with coopera
tiv enforcement programs.

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                               - 3 -


     On May 11, 1981 EPA promu1gated a rule (io PR 25352V gvsern
procedures to be followed by the Aami ni strator in rescinding
primacy.  Under these procedures, whenever the Adrsi n 1 st-ator ma*as
a detenni nati on that a State is^not adequately aiscnarglrsg its
use enforcement responsi ai 1 i ti ss'r ne nust send a notice to trie
State specifying the deficiencies in the State's usa enforcement
program.  If after ninety days from receipt of a notice by a State,
the Administrator finds tnat the Jtate has not corrected the
deficiencies set forth in the notice, the Administrator may rescind,
in whole or in part, the State's primary enforcement responsibility
for pesticide use violations.  In practice, if someone complains or
deficiencies are discovered during an evaluation, the Regional
office will contact the State and try To r*so1 the problem prior
to formal rescission procedures.  Generally, few problems have arisen,
and those were satisifactori1y resolved.

Training/Guidance

     Throughout the development of the cooperative agreement- pro-
gram, EPA has placed a major emphasis on training state pesticide
Inspectors.  State inspector training has been accomplished primarily
by the Regional offices through formal training sessions and througn
having experienced EPA oesticide insoectors assist State inspectors
in the field.  In addition the National Enforcement  Investigations
Canter (NEIC), in cooperation with the Co~a1i3nca Monitoring Staff
(CMS) and the Regions, conducts 'js/Tn S'jse ' i /st'* catl on *o"< s^oo, "
fGf State pesticide inspectors.  Tnase -vcrxsnops cover s:a:a a*
the art pesticide drift monitoring techniques and basic use/misuse
investigation techniques.  Tne worksnops include ootn classroom
and field training.  EPA Intends to continue both these training
programs in the future.

     In addition to inspector training, EPA has emphasized the
improvement of State pesticide laboratories and training of State
chemists to ensure the quality of State pesticide analytical data.
Under a Memorandum of Agreement between CMS and NEIC, the NEIC con-
ducts chemists training workshops, provides advice to the States on
analytical techniques, conducts on-s1te reviews of State pesticide
laboratories to evaluate sufficiency and recommend improvements,
and conducts a ctieck sample quality control program.  Thse
activities will continue 1n the future.

     To n$qr tlrat compliance/enforcement activities were properly
carried out, an inspection manual and case preparation manual
Including a FIFRA civil penalty policy was Issued to the States.
Additional strategies and penalty policies were developed for
new regulations.  In addition, guidance has been issued to the
Regions/States governing response to cancellations/suspensions.
CMS and th Office of Legal Enforcement Policy recently released a
revision of the Pesticide Case Preparation Manual as the FIFRA
Compliance/Enforcement Guidance Manual.

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Cert". ficatTon and
Tra-i n: na ^ro
      n FY31, OMB transferred tne program to
enforcement program.  This transfer
better coordinate the two programs.
                                    provided
    trie  con: ,
    an  opPoft.
to
                                        if pesticide applicators
                                          Plans an proved by
     FIFSA provides that certification
be accomplished under State Certi *' ct i on
EPA with training provided by the State Cooperatw-e Extension
Services (SCES's).  This objective has been largely accomplished.
Only Colorado and Nebraska lack approved certification plans and
only the Colorado* SCE.S fail
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                             -  10  -


 General        _____                      _____

     As mentioned  previously,  the Federal ro'e sii'te^, as Tic"a
 States received  grants, to the oversight of tne coooertive proa-*?.,
 enforcement  response  for State referrals, enforcement programs in
 States without coooerative programs or primacy, aic 3 compliance
 monitoring and enforcement program consisting*of data audits,
 import ana export  surveillance and efficacy testing.  With tne
 exception of the data audit  program, which is managed at Headquarters,
 the Regions  have primary responsibility for the Federal Program.
 CMS provides guidance documents,  policy interpretations, technical
 support, and oversight for Regional activities.

 Data Audits
     The data audit program for studies submitted in support of
pesticide registration was instituted in 1975 after the Food and
Drug Administration (FOA) found that studies submitted to it had
serious deficiencies.  The strategy has been to audit studies at
problem laboratories, audit studies of special significance to"
regulatory decisions, and conduct routine audits at all pesticide
laboratories.  Under an Interagency Agreement originating in 1973,      I
FGA conducts inspections at laboratories wnlcii conduct iiaaltn           I
effect studies.  EA inspectors primarily conduct audits of environ-
mental studies.  E?A scientists participate on audits as aoor'
A Data Audit Panel within Office of Pesticides and Toxic S-jbS'
(OPTS) targets inspections, reviews reports, and r'ecom-


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 the United Staes and refers the matter to the appro-
priate EPA Regional Office for resolution or enforcement action.
In addition, a Notice of Arrival form is required to be submitted
to' EPA for all Importations of pesticides and devices.  An annual
average of 4375 Notices of Arrival hav been received and 670
Inspections of Imported products hav been conducted for the past
few years.

Efficacy Testing

Disinfectant Testing

     The Federal program for disinfectant testing, which 1s no
longer active, involved afftcary testing of hospital dlsinfectan
Sucti testing 1s Important considering that failure of hospital

-------
                                            a o*
                                            v a in
                                            0?a's
                                            ng on
                                            of 1 1
                                            a la;
                                            i I a r 5
                                            r i t y
                                               "M
                                            i
                                               wa
 a -,-:,
 Be':;

1  sa-3

,  ana
needs ,
S  prop
s  not
 200
las i
y sjs
garmi
 altn
oseci
i nclu
                                                            Sams'!as
                                                            n 1530
                                                            3 a n c e c
                                                            ci aas
                                                            ou CT
                                                            an
                                                            aed 11
d: s i D fact ants can contribute to the incidanc
vultarab'a p at i ants and 'esj't i : jn.-ecassa
of nosnital staff to pathogenic organisms.
laboratory formerly performed efficacy tasti
Der year.  The failure rata ranged from 45%
to 721 of 40 samples in 1982.  I'ne Beltsvili
tasting of disinfectants, sanitisers, atari!
in Octcoer 7932 due to competing higner-prio
the capability to perform such tests remains
efficacy testing program for FYS5; however,
the priority listing of OPTS programs.

Ultrasonic Device Testing Program

     Under an Interagency Agreement between the FDA's Winchester
Engineering Analytical Center and EPA's CMS, the FDA tested the
acoustical  properties of a dozen different ultrasonic pest control
devices being manufactured in the United States.  This information
was used to select "representative" devices for testing the principl
of ultrasound on rodent control.  The efficacy testing is being
conducted under a separate Interagency Agreement with the Denver
Wildlife Research Center, Fish and Wildlife Service and CMS.,  A
final report on the first of six devices was recently received,
and the other tests and reports will be completed by February
1934.  CMS and OPP will use this information in the regulation
ultrasonic device labelling claims which are overstated.

E 1 act roma anat i c Device Tasting 3nc-a-i
                                                            on of
     A orogram similar to tha ultrasonic program was conducted
for devices which purport to control pests utilizing tne principle
of electromagnetism.  The Bureau of Standards, through an Interagenc
Agreement with CMS, conducted tne 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 o*f devices from the consumer marketplace.
Rodenticide Efficacy Testing
     The Office of Pesticide Programs funded an Interage-ncy Agree-
ment with the Denver Wildlife Research Center in FY83 to conduct
a national prograa to test rodenticides for efficacy.  CMS is
participating 1n this program by coordinating the sampling,
chemistry testing, efficacy reviews, and enforcement response,
any, for the rodenticides.
                                                               if

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                               - 12 -

Monitoring  of Federal S_s_ray Programs	

     The EPA tnrougn tne Federal enforcement program ^- v. 2
cooperativ-e State programs routinely monitors spray pr^raas
funded by Federal agancias.  For instance, app"! i ca-* its sy
for-hire applicators during the Grasshopper Control Program nave
been monitored by tne States of New Mexico, Texas, ana Oklahoma,
and oy EPA  in Nebraska and Colorado.  The EPA ana tne States
may also conduct use investigations far smaller scale programs
Including aquatic weed control, forest p-est control, and pre-
dator control programs.


Present State of Compliance                     _"."....._.

Regulated Community   	

The following is a list of known members of the regulated co-muni'ty:

o Number of Rsgistarad Establishments                     11,000

o Number of Applicators Trained and Certified

  Private                                              1,500,000
  Commercial                                             436,000

o Numser of laboratories Conducting FI"*A Studies            -33

o Number of Notice of Arrivals Received in 1982 (imoorts)  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 1932          "         373

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

     This list does not Include information on the total number of
pertlcltle users or pesticide d*lers of unrestricted pesticld-es.
Many users of pesticides only use general use pesticides and there-
fore are not certified.  This 1s especially true of homeowners who
a.re 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 is much less than
the effect of violations by nembers of the known regulated coimnunity
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 *r"
uncertified generally affect a more United population.  In addi"
violations by users whlcft result 1n serious hann are likely to to-
rt ported to tti Agency.

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                               -13-
SDe c
                Actions
     T^e shift from a Federal  to 3  State  p'-ocra
increased numoer 3* inspections and increased  f
complete aaca oase on enforcement actions wnicn
activities only exists far FY31 and FY82.  In  ~
50,104- 3tate inspections was conducted.  The  oe
resulting in action was 17.4.   In FYS2, a total
inspections was conducted.  The percent insoect
actions was 13.1.  Violations  figures for sped
inspections indicate a nigher  rate  of noncompli
requirements than for non-use  related requi reme
n has
i e 1 d
 i ncl
731 ,
rca 'it
 of  5
i ons
f i c  t
anca
its.
                                                  uce
                                                  2  t
                                                   0*
                                                  9,3
                                                  ras
                                                  y?e
                                                     se~ 12 .
                                                     s S:ate
                                                     o t a I  of
                                                      i isoec
                                                     17  Scat
                                                     u 11 i n g
                                                     s of
                                                      use  re
ti ans
a
1 n

latad
     The numoer of Federal  inspections for FY81  and FY82 was  225^
and 2021 respectively.  In  FY81 ,  the number of enforcement  actions
was 755 and in FYS2 the number was 1139.  These  figures  induce
actions oased on referrals  from tne States.  A detailed  breakdown
of the numbers of inspections and actions can be found in Tables I,
II, III, and IV.  (See Appendix.)

     Sotn. EPA and the States ara  collecting a large body of data
related to specific types of violations.  The Agency will inc'luaa
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.
boa ! s a " a
Long Term
J r ! o r i t i a s
Goals
     Long term goals for the FIF3A Compli anca /Enforcement  Program
are listed in order of priority below:
                                                           of
o
o.
o
o
o
o
o
o
Expand FATES to include State data and assure completeness
Develop a predictive model to set priorities.
Ensure fhat all States participate in cooperative  enforcement
agreements and the C & T Program.
Improve EPA-State communlcation systems through the use of  state
the art technology, eg.f  use of electronic mail.
Provide guidance and training to the Regions for data audits/
laboratory inspections and case preparation.
Conduct periodic surveys of pesticide use to improve priority
setting system.
Cotrtlnue reflnemetrt of program management for the  cooperative
enforcement program, the C 1 T program and Federal program.
Improve program evaluation.
Ensure the adequacy of the C & T program.
Review certification and training materials.
Ensure adequacy of Federal Compliance/Enforcement  Program.
Promote programs to prevent violations of FIFRA.
Provide technical and legal support to States.
Continue to provide training for State inspectors  and chemists.
Continue cooperative relationship with States.
                                                                data
                                                                   of

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o Develop compliance monitoring strategies and enforcement
  response policies for new regulations ani sjssans^ons
  cancellations as appropriate.
o Update the Pesticides Inspection Manua1.
o Consolidate FIF3A enforcement reoonse oolicies.
o Revise FIF3A 7 estaolishment "registration ru 1 a ana reporting fc--
  to improve tne usefulness of data in tne system.
o Expand formal referral systems within the Agency.
o Expand formal referral systems *itn other Agencies.
o Improve referral system between the Regions and States.
o Expand work with the press and special interns* groups.
o Continue Integration of inspections.

Near Term Priorities

     Priorities for the FIFRA compliance/enforcement program' throws;:
FY8S fall into the following management, compliance monitoring
enforcement response and certification areas:

Hanaoement
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 to
  ensure that the documents are enforceable.  In o"der to io 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.  Tnerefare, a formal  syst
  of communication between GPP, Office of General Counsel, anc CMS
              vld
o Finalize strategy for conducting data audits and Good Laboratory
  Practices (GLP) inspections.                                           I
o Finalize enforcement response policy for data audits/GLP               |
  1nspections.
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 St-ats.
o Provide training for Stats inspectors and chemists.


  Promulgate final FIFRA 4 rule requiring dealers to keep records       |
  of their restricted use pesticide sales and clarifying where
  comnercial applicators must keep their records on their applica-
  tions of restricted use pesticides.
o Prepare additional policies for the FIFRA Policy Compendium, as
  needed.

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     i aica ^on*tori no
rogram gulaance
                        i: c a t a s t nat
                                               75",
resources should be directed at use
 genera ; \j
problems  and 25*
related priority problems.  The priority setting g'ji:2"t? '3 -ec
to be flexible, allowing a snift in inspection targa-s --o^ yea
year based 2,-. shifts i r, State specific problems ais ^-j1^ -Ir3A
regulati ons.
                                                                 to
                                                   a t n e data
     In addition, the Federal program will emphas'i
audit/laboratory inspection program.

Enforcement Response

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

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

o Violations related to those priority use problems which
  EPA and the State have agreed to track under primacy ana
  for which the State does not take appropriate action.
o Violations related to other priority use probla-s established
  by the States or EPA.
3 Submission of false data to i?A in conjunction witn pes:i :': 3
  regi strati on.
o Sale of Restricted Use Pesticides to uncertified applicators in
  Statas with Fsdera": Programs.
o Label or formulation violations likely to result in harm to
  health or the environment.
o Violations of Child Resistant Packaging regulation.
o Pesticide enforcement registration and reporting violations.

Certification
o EPA will conduct Certification Programs 1n States without
  approved certification plans.
o EPA and States will ensure that applicators are made aware
  ciw-n-gin-g technology.
o EPA and States will continue to certify new applicators.
o EPA will prepare guidance to encourage States to address
  problems 1n C S T materials,
o EPA will prepare guidance which ensures
  meet Federal standards, as appropriate.
                                                             of
                                                           major use

                                          that State C 4 T materials
Plans for Achieving Program Goals
     This section discusses the compliance monitoring plan, the
compliance promotion plan, plans for responding to noncompl i ance ,
certification and training, Headquarters/Regional coordination,
federal/State relationship, and cross program effects.

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                               -10-
Conoliance HonitorinoPlan
Objectlves
     The basic objectives of ttie compliance monito-i 15 ^'jn -:
1) to provide a visible enforcement presence which wi ' ;  encourage
voluntary compliance; 2) to collect evidence to support  enforcement
actions; 3) to expand the data base for determining comoliance ay
the regulated community (FATES) and to use this information to
identify persons lilcely to be in noncompl i ance; and 4) to discover
problem areas requiring resolution fhnsugh re-gulatory initiatives
i_  . nnn
by OPP.

C omp Hance Hon 11or 1 ng Too 1 s
     Tools available to EPA and the States for monitoring compliance
with FIFRA include data review, letters, and on-site inspections.

     EPA can determine by reviewing available data whether an
establishment has met its 7 reporting requirements or wnetTer
there is some questionable registration data.
     On-site inspections are the major method through which E?A
monitors coitipl i a.ica with FI?3A.  T'.-.ass \ r.spsrfi :*; i.-a ic.-.i-ctsJ
in response to complaints and on the basis of target selection
under a neutral  administrative Inspection scheme (NAIS).

Inspections Based on Referrals/Complaints

     Both the Agency and the States place a hi g-h 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
pesticides 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 Unking specific action with a specific misuse.

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

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                               - 17 -
     Misuse is difficult to detect jn'ass an inspect:" -3 ;
during actual use or soon a.rtar c.ie use of tne aest ;::: = .
fore, use inspections are conducted in --esoonsa to 2 ::~:".j;i-
referral  or during tne actual aoolication of tne 3-;s.; c'-2 .  '-25'-
tlmate complaints/referrals regarding pesticide -.'sjse -:ay 02
ineffective if tney are not made and investigated oronot1./ sec a use
the evidence, especially in the case of *vgnly toxic organoanoso^ates
will no longer be there at the tiTie of the investigation.

     Even if there were no limitations on entry authority, evidence
of pesticide misuse may be difficult to detect during a  planned use
observation.  Because inspectors would not generally otherwise know
when and where a commercial 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 Inspecti ons	
     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-ela, or wnether scientific
S2ta submitted in support of a pesticide "e^1'st rj^i on correct':'
reflects the testing wnicn *as condu
     Since most States have regulations requiring dealers of
RiiP's to keep records or t.ieir ad^es, i; ii peict;c1> ejjj  ."j,-
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 1s 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 aust keep their records on  their
applications of RUP's.  This rule should appear 1n the Federal
Register early 1n FY84.

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Ta rge tt i n g
     As indicated on page  6,  EPA  and  the  States  use  the  priority
setting system for pesticide  use/misuse  to  cetermine  specific
categories 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  sased
on major existing or anticipated  problems.   Each neutral  scheme
includes a set of criteria designed  to  help the  Agency  and  States
achieve the best cost/benefit ratio  between the  use  of  compliance
monitoring resources and detection of violations.   The  criteria
applied to all facilities  under a neutral  scheme vary  based  on
individual priorities but  generally  include the  following:   viola-
tion history, production volume,  amount  of  specific  pesticides
used, inspection history,  and location.   Inspection  targets  are
selected at random based on available resources  from  the  facilities
identified through application of the NAIS  criteria.

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

     The priority setting  system  for  p roduct/f aci 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
Wi thi n 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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T
          Expand Referral Systems
          'A1t h 01 n t r A g e n c 1 a 5	
e tne Agency nas -5*2
or violations  "~~  ""
                                 a'  systems  *  -
                                 Consumer
                                                            r
          srgauCfcS or vioidiigns witn I-JM, ugnsumer .* r o C "j C t Safety Camr
          (CPSC), Occupational Safety ana Healtn Administration (OSnA),
          Federal Trade Commission (FTC), it should expand tne systems.
          should encourage States to set up similar systens.
          Improve Referral System
          Between the Regions and States
               FIFRA 27 requires EPA to refer all significant allegations
          of pesticide misuse to the States.  The Interpretive rule provides
          specific procedures for the referral and tracking of such cases.
          Although all Regions have imolemented 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 Grouos
               Botn EPA and the States perioaically encourage tne national
          and local trade oress to *ri'e articles on new and existing pesti-
          cide control  'equi renents.   Knowledge of FIF3A ana 5:2te pesv'iiis
          1 jws .nave co"sistantly results^ in discovery of v'olatijns of oot?
          laws.   Because evidence of  pesticide misuse'may rapidly disappear,
          ic  is  particularly  import an: trtdt EPA ana :ne Screes  expan,
          efforts to work with such groups as  farmworkers to educate them
          about basic evidentiary requirements and the 'need to contact tne
          government as soon as possible after occurrence of the alleged
          misuse.  Efforts made 1n this area continue to be restricted by
          resource levels.  CflS has Issued a Complaint Form, which was
          sent out is an update to the FIFRA Inspection  Manual,  to facilitate
          tti reporting of cotnplalnts or referrals.

          Integration of Inspections	
               To make the
          States currently
          proximity of the
                 most effective use of resources, both EPA and the
                 conduct inspections based in part on geographic
                 targets.  Both will continue this approach
     EPft will also continue Its program of Integrating FIFRA and
TSCA data audit/laboratory inspections.

Inspection Frequency
                  the past EPA and the States  were to Inspect  establishments
                  urlng general  use pesticides every  5 years  and  those  manu-
     In the past EPA and the States were t
manufacturing general use pesticides every
facturlng RUP's every 3 years.  In practic
on the number of establishments existing 1
                                  5  .
                                ce,  this  has
                                 n a State.
                                                                varied  based
                                                                EPA has moved

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                                - 20 -

 away  f-om  requiring  a  specific  frequency in its cuHance.  I-sta
 tne Agency  suggests  that  frequency fie astaailsiea f-c-:" :^s
 priority setting system.  This  is trua far jnisusa as 3*' is
 astao li snrsent  inspections.

      Laboratories are  axoectad  t*3 oe inspected an 33- t^e lata au:it.
 laboratory  inspection  program every 2-3 years.

    Inspections at device producing establishments snould 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
 testing 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 separata 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-uo Insoections
     rollaw-up insoections are conducted when more information
is needed for a possible enforcement case or when violations
hive ban fc'j~- i?j the ^3"io-'State iete***^'"as t^it jio*1?*"
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.

I nsipecti on Qua 1 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 EPA
are described under the training section on page 9.  Aside from
training, basic guidance on the conduct of pesticide inspections
1s contained in the Pesticides Inspection Manual.  This manual
will be up-dated and revised 1f resources for this activity are
available in the future.                                                 I

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

-------
     In accordance with tne Agency's Quality Ass-ranc*  I-'  -
ments, States receiving grant money througn trie coooe -2 : * ve  e
ment program flust develop QA Plans covering botn CD^Silatca  m
and sample analysis
                       hese QA Plans must be
                                                           ne
Quality Assurance Officers annually for review aid ajcrova1.
Compliance Monitoring Staff, with tne approval of v^e H?A Cui
Assurance Management Staff of QRO, has provided guidance to the
Regions and States on the development of QA Plans.

Compliance Promotion Plans   	

Qbjecti ve	
'arcs -

i e 3 i 2 n;
"is
ty
     Compliance promotion is an important component of any
successful compliance program.  The objective of compliance pro-
motion 1s to ensure that the regulated community is aware of
the requirements of FIFRA and related Scate pesticide laws and
understands what It must do to comply.

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

Educational Proarams
                                                           ;.-^A
Certi fi cati on and Trai ni ng.  Perhaps the most widespread compliance
promotion rool is the pesticide applicator training and certifi-
cation program.  This program is conducted by EPA in two States
and in other States by tne States themselves.  It ensures that both
private (farmers) and commercial applicators (all other*) 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 Bate Mais and xani nations 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 1n part through cooperative agreement funds
During the first phase of project SAFE, trainers were trained to

-------
                             - 22 -
conduct fly-ins* to taacn aeria'  applicators setter cj'::->:
techniques to minimize pesticide  drift ani to ootai^ ::-.:-2'
control with the minimum amount of pesticide,  The-* is :=  see^
three trainer fly-ins which involved aporoximately  3 States.
During the next phase of the program, these trainee specialists,
mostly cooperative extension staff, will  be conducting fly-ins  -"or
aerial applicators in tne'r States to help trie applicators calisrata
and apply pesticides in the most  environmentally  effective manner""'

Farmworkers Program

     Several y*-ar *go, the Agency initiated a .pro-gram to  evaluate
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 specific laoel language.  The  regulation is
enforced at the user label in tnat it is  illegal  to use  a  oesti :i *e
in a manner inconsistent with its labeling.  A ,vor
-------

-------
        to
                               - 23 -
                            Laboratories
     TV! s policy is stated in tne final FIF3A 3occ Laboratory
Practice Regulations (GLP's) which are to oe p rc~-j * gi ;a a in FY5-.

Sjjsaensi on/Cancel lati on of Registration

     This is an action whicn may De considered if tne statement
of compliance or noncompliance with the GLP's tnat 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 (0 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.

         aci 11 ties
     Senerally ,  i f Fed
the EPA does not issue
Drier 12038, Faderal C
wnich established a go
facility compliance wi
assessing penalties, E
Noti ce of Warning i s 1
and the EPA works with
plan.  If the problem
is referred to OMB.
                      sral  Agencies ar  fcu^.i : "  v1:lit"
                       penalties.   This  is  in accordance
                      omoliance With Pollution Control  S
                      vernment wide program for ensuring
                      th polluti on'control  requirements.
                      PA tries to  resolve  the problem.
                      ssued to notify facility managers
                       the  violative agency to establish
                      cannot be resolved between  agenda
    - z * r i i
 , < * . ~
  . - n te
tandars
 Federa
  Inste
Fi rst,
of vi ol
 a re me
s,  the
of
s,
1
ad
a
ati ons,
dial
matter
          regard to criminal  action,  the  Department  of Justice
has indicated it would not allow EPA  to file  suit  against  another
Executive Agency.  In FY 1983, EPA issued a warning  letter to  the
Fish and Wildlife Service for failure to  comply with the  pro-
vi si ons 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:

   Technical Assistance - to  ensure cost  effective and timely
    ompliance.

   Compliance Monitoring - to -monitor actual  compliance.

   Fiscal'Planning Assistance - to assist OMB 1n evaluating budget
                                                                         ie
               US Of funds.

-------

-------
                               -  30  -
Cooperative Enforcement
     As the cooperative enforcement program  has  a /: '/*
wt  agreements have accepted increasing raspons i 51 it/
fully in ail pnasas of the program wi-.h ?A.
                                                           now  snare
Cornp' i anca/Hnf o reagent Acti vi t i es

     The States with cooperative agreements conduct  all FIFSA
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 tiie State.  (Th-es-e major spray programs are
usually funded by Federal agencies.) In addition, EPA  through
NEIC proviaes 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
     all
         enforcement actions  on  violations of only State
     re-far all ylolrtiorvs  of  only Federal  law product  anc
             i* <
                                                          aw
taica
will
ne.nt registration requ i regents -0 i?A for enforcement acti
Where tnere is a violation of oo*h 3~ate ana Feceral law, a
may take enforcement action itself or refar the case to Z?A
is unv/i'ling 2r urable to io so.
                                                               it
     All States with cooperative agreements also have primary
use enforcement responsibility (primacy).  Under the terms of FIFRA
25 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.
Stare Program Oversight
                                        cooperati ve
                                        are closely
                                                    enforcement
                                                    involved in
     EPA has primary rspon-sibi 1 ity for
programs oversight; however, the States
this process.

Program Guidance and
Compliance/Enforcement Pri orities

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

-------

-------
own annual  program priorities
                                      Specific outputs
pijnra/ an'orceiient activities ar> negotiates on t*2  ?i:*s  if fe
Stats priorities and productivity factors in the  guica^ce.

Prog ram  va 1 uat i on

     *ajor elements of tne .Regional evaluation o* StJta  pro grans
include:

o Semiannual  reports by the States of their accomplishments  comoar
  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
  review evaluation reports before they become final.
                                                         to
o Training and close informal
  acti vi ties.
                        review  of  the  quality  of State
     The effectiveness of a State program is  judged primarily  on  .
the quality of its priority setting system,  its  adherence  to
negotiated n unite r of outputs,  the quality of  its inspections  aid
the adequacy of its enforcement responses.

Fa serai Program in Npn-Coooerative Agreement "States

     In Colorado, N
-------
                               - 32 -


      EPA will continue to conduct car*'*icat*-3n ^r---j-;
 dit^cut  cs-ti- cati on plans.  3cth E?; an: State's -:ci-.s
 material and  : of orinati on to ensure tnat a?p", i ca" 3-5  i-= 2,
-------
                               - 33 -
U p c a t e of
     The core manual and various category manuals *e-
updated to reflect cnanging neads ana tecnnolocj.  Ccr'es of trie
manuals *ill oa orintsd by the State Cooperative Exts^s'on Sarv-css
(SCES).  "nese and other training materials will :* cataloged a:
tne USDA Seltsville library using EPA funding.  "> Droalem csnt'-iua
to be future availability of copies.  Neither t.ie Government ?ri.?fi-.
Office or the Department of Commerce will maintain copies of :-?ese
publications for distribution and sale.  Therefore, wnile copies
can be reviewed at the Beltsville library, a user can only print
his own copies from a camera ready copy, or if the timing is correct
order from a SCES which is a-bo-ut t 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 matcing
it available when requested to groups other than the SCES's.

Indian Tribes
                                     EPA funding assistance to
                                     draft Indian plans are no.w
                                  some tribes will  probably ha've
                                  EPA must then urge these tribes
     Ten Indian tribes have received
develop certification plans and some
being reviewed.  Therefore, while
appro ved plans, others will not.  u.-n must, m^n u. d= unc^c  ^ < > w*
to enter into an arrangement with States to perform certification
on the reservations or ?A must establish Indian certification
programs.  There is also the possibility of sorce split  options,
such as, States issuing certificates and E?A enforcing  misuse  anc
denial, suspension or revocation of certification.

Review 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 iat*rst in developing a program which will  initially
address only commercial applicators.  The Nebraska State Cooperative
Extension Service has provided training since the program began,
and this should prove an asset in the effort to have the Nebraska
Department of Agriculture develop a certification program.

Federal Facilities	
       Federal agencies can have their employees certified under
State or EPA administered rt1f1 cation programs.  Most Federal
agencies chose this option, even though it imposes geographic
limitations on wlrer* tte applicator can apply pesticides*  I.e.,
the State Issuing the certificate or States with reciprocal
agreements.  However, because some Federal applicators must work
1ft sever*!  States, often on sfcort notice, EPA allows Federal

-------
 agencies  to devsloo certification plans for tneir e"'v"5
 Applicators carti'^ed under Federal agency plans C*"1 irvy
 pesticides anywhere, but tnis certification is limit*-: to* 0'
 duty  functions.  To data, three Federal agencies, DC3, USDA
00
     have approved Federal agency certification plans
Cross Program  laments
     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 1n order for them to effectively ma
-------
                                -  35 -
           'Vasta  >""3crn
      Pesticides  are  a major  constituent  of trie  .vasras  at  a  ;a-
number  of Hazardous  waste  sites ana  information  c?  regi st ran- s
ana  producers  is  needed  for  clean-uo  cost recsve"/  and  associa
enf orca-rtent actions.  Information on  oesticide  ,ianu f act j rars  1
aeen orovi iad to the Office r>f Waste Programs  T'T r ta
of the Agency's dioxin monitoring orogram.
                                                           as par
     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 RCSA regulated
pesticides identified under FIFRA or associated Stata enforcement
programs  requires close cooperation with State and Federal RCRA
personnel
on disposal
RCRA.
            Pesticide
            practices
i nvesti gati ons may
which point to tha
also provide information
need for regulation under
Water Program

     Use of pesticides resulting in drift into water
a FIFRA and State pesticide enforcement function havi
interface with Water Quality Criteria established t>y
Programs.  Pesticide contamination of grounawatsr "ss
pesticiae usa also requires coordination between t"*
and watar 3rggrjms.

InterAgency

Data Audits/Good Laboratory
Practice Inspections
                                                     is
                                                     ng
                                   rimari ly
                                    direct
                                                       t * n
                                                     pes:
     As discussed on page 10, FDA conducts inspections for EPA
at laboratories which conduct health effects studies.
Spray Programs

     As discussed on page 28 under Federal
have monitored spray programs conducted by

Efficacy Testing
                                           Facilities. EPA/States
                                           U50A and the DO I.
     As discussed on page 11, EPA has coordinated with FDA, USOA,
DQI, and the Bureau of Standards to have testing conducted on
ultrasonic devices, electromagnetic devices, and rodenticides.

-------
     EPA worses *:" t n otne" r e d e " a 1  Ageic'35 3 f '
tne development and i r,z 1 ementat: an of C S 7 2":
300, USDA, and 001's Sursau of-Land Management
programs.

Food C:rrt2rn1 naff an
                                                -save
     USOA arvd FDA monitor  pesticide  residues  in food.  3otr.
agencies forward reports on  food  contamination  by  pesticides
to EPA for  followup  investigation, if  appropriate.

Referrals and Information  Exchange

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

Program evaluation
pHa
me as
eval
mode
At t
131
-,* c
     A system for evaluating the effectiveness of the F1FRA com-
    nee/enforcement program must define specific areas for evaluatio
    ures of program success and mechanisms for performing the
    uation.  The Agency can best measure its success in achie*
    lianca *han it nas dsvelopea I) an a aequate sat a oase for
    t i f y i n g me?noe.'"S of the regulatad csnmuiity and 2} areilt"'
    Is designed ta select those -rra^oefs most l: ca-s*3er ^ts program a succass '- on';
    of tnose persons inspected under a neutral scneme are violators
Evaluation Areas
     Areas for evaluation Include 1) adherence by EPA and tne
States to quantitative and qualitative performance commitments; and
2) the extent of compliance with FIFRA by the regulated community.

Measures of Success

Adherence to Commitment

     The adherence by E?A and the States to performance cowmlfments
can be measured by the following factors:

o Implementation of a priority setting scheme.
o Adherence to output commitments as measured by the Administrator's
  Management Accountability System.
o Adherence to Inspection procedures required In guidance.
o Number, promptness, success and adequacy of enforcement act1ons_.
o Accuracy and timeliness of compliance data entry a-nd retrievaf

     These factors will allow a quantitative and qualitative
evaluation of the syste*.

-------
C o mo ! i a n c s by the Regulated
                                   ty
      'he extant of conD1 :" aice fi~ t'
      'd to a limited degree sy tie
                                      agu " a tec : :
                                       ]owng "5 :~
o Number af applicators trained and certified.
o ? rooort i ona t e numoer of estaDl i snrnents 
-------
                              -  33  -
 ?-3gram  Modification.
                a a t a from " A 7  5 , S s 2 1 2 3 - 3 g " 2 :i
                                                 3 v
       t?A uses
-27'ews and r^e overall program rav*ew, 13 nosi*.' 's C2""3
enforcement program as necasa^y and to g^v? iiput to O30 c:
"gulatory cnang5 necessary
enforcement,  or compliance.
                                  acilitate  comaHance monitoring,
.- utura  ju ' 33nee
     The  following  is  a  list  of  guidance documents  curren1
development  or  consideration.*
                                                          >y under
o FY85 Cooperative Agreement Suidance.  This document will modify
  C i T allocations,  specific  instructions on  transferring enforce-
  ment priorities to  the C  4 T programs, evaluation of the C it T
  program plans and training materials, and improved productivity
  factors for negotiating grant outputs.

o FIFRA Compllance Program  Pol 1cy Compendium further defines the
  requirements of F1FRA regulations.Currently there are twenty
  such policies in the compendium and three under review by the
  Regions, the States  (through SFIREG), and the program office.
o FIFR_A Inspection Manual provides information
                             cnai i-of-:ust3iy
   ions, coil acting samples,
  suooort documents,
  Flr^A inspections.
  are aval 1aole.
                     and other :'n*3rr:at:on necessary to
                      This document snould se revised i
                                               on conducting insseC'
                                               scedurss,  rra
    	                                           i-'O'l* 11 *j
  orig i ha 1  pena 1ty p o1i cy ha ve been developed over the years
  reflect  amendments to the law.  These will all be combined
  one  comprehensive document.
                                                             to
                                                             into
o. FIFRA COfflp_1 iance Strategies,  The FIFRA Compliance Strategies are
  developedfor al1 rules promulgated under FIFRA.  A compliance
  strategy Identifies the (a) requirements of the regulation, (b)
  the typ of act-Tons which are appropriate for the violation, (c)
  the Inspection scheme (from which the regulated community is
  targetted), and (d) allocation of responsibilities between Head-
  quarters and the Regions.

o Quality Assurance Plan Development Guidance  When manuals are
  updated, and as resources are available, CMS will coordinate
  with the Office of Research and Development's Quality Assurance
  Management Staff and tne NIC in developing a 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 E?A
  annually.
    A comprehensive 11st of existing compliance/enforcement guidance
    docyiaents 1s Included 1n the Appendix vf tne FIFRA Cowpliascs/
    Enforcement Suidance.

-------
- 39 -
   APPENDIX

-------

-------
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-------

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-------
                            * V "" "*
                            - v , 3
                                             r / a 
 Producer Estaolisn
   Inspections
 Usa  Investigations
 .Marketplace  Inspections
 Import  Inspections
 Sealer  Inspections
 Laboratory Audits/
  Inspections
TOTALS
143
182
1115
332
359
17
^-^ 
2303
23+
^  .-i
320
434
955
8 _
2621
257
435
291
241
945
4
     __ .
2254
235
i " 1
233
306
719
13
2021
1 v t
* 2-
210
301
0
	 25
^^^^^*^^^^
821
    Quarter  rt'Sj  Totals

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            :::3i ENFORCEMENT ACTIONS

CivM Co^O'aints
Ini t* atec
Criminal Deferrals
In* ti atad
Stop Sale, Use, Removal
Orders
Notices of Warning
Inport Detentions
TOTALS
r v 7 3 rv0 ~ v 3 '
*
252 175 15:
2 a :
479 y 113 105
507 831 429
91 70 71
1332 1194 755
r . ; ^ r / 5 "
*^ ^ ^
^
50 42
855 1270
53 11
1137 1545
I/ Second Quarter FY83 Totals
   An additional  24,000 Stop Sa:e Orders  were issued  to  firms  t
   neld susaended 2,4,5-r an
-------

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             UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                         WASHINGTON, D.C. 20460
                             JW 151985
                                                           OFFICE OF
                                                    PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM

SUBJECT:  Final GLP Compliance Strategy

FROM:
TO:
A. E. Conroy II, Director          _.  .
Office of Compliance Monitoring(/EM-342)

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 R_ 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 available.

Response-  The GLP regulations have provided adequate notice to
all persons, 1n the sectior 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 or 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.

-------
 Comment  2-
 have  stated
 OECD  GLPs).
 substances
 devi ations
 data  were  i
 reports  are
 compllance
 OCM."
                                -2-
 OTS has noted that "some data submi'tted with PMNs
 that studies were done according to GLPs (usually
  However, protocols are often missing, test
are inadequately defined, and there are other
from any known GLPs.  OTS recommends that claims  that
n accordance with GLPs not be allowed unless  the  data
 sufficiently detailed to support the claim.   As  a GLP
issue, this recommendation should be considered  by
Response-  OCM does not
from making claims such
this by amending the PMN
statements with PMNs ind
adhere to the GLPs and 2
detailed reports.  When
compliance with the GLPs
studies supporting PMNs
schedule inspections/aud
             have the authority  to
             as described  above.
              rule requiring  submi
             icating  whether  the  s
             )  support such  claims
             OTS has  concerns with
             ,  OTS should  provide
             and the  names of the
             its at the laboratory
                                               restrict persons
                                             OTS could remedy
                                             tters to 1) provide
                                             ubmitted studies
                                               with sufficiently
                                               specific data and
                                             OCM a list of
                                             labs.  OCM can then
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
Don Clay
Steven Schatzow
Terrell Hunt
Ruth Bel 1
Jim McCormick
         Air  and  Waste  Management  Division  Directors
         Environmental  Services Division  Directors
         Regional  Toxics and  Pesticides Branch Chiefs
         Office of Regional Counsel

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   Strategy for the Enforcement of the Good Laboratory Practice
                 Regulations Under T5CA and FIFRA
Overview

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

     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

Applicability

     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, pnvironmental  effects, and chemical
fate testing under TSCA a*id 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 related to TSCA Section 4 Test Rules, under
FIFRA to Section 3 'applications for registration), Section 5
(experimental use permits), Section 18 (emergency exemptions),
and Section 24{c) (registrations for special local needs), and
under FFDCA to Section 408 (tolerances for pesticide residues  on
raw agricultural commodities) and Section 409 (food additive
regulations).

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                               -2-                    .

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

Specific Requirements of the GLP Regulations

     The requirements of the GLP regulations are contained in
40 CFR Part 160 (48 F_R. 53946, November 29, 1983) and 40 CFR
Part 792 (48 FIR 53922, November 29, 1983).  Generally, the rules
contain proviTTons 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
with the GLP regulations;
the study was conducted in accordance
     (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.

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                               -3-                 .

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

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                               -4-         .         -

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


     (3) Facilities (Subpart C).

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

          (a) Animal care and supplies;
          (b) Handling test and control substances;
          (c) Laboratory operation;
          (d) Specimen and data storage; and
          (e) Administration and personnel.
     (4) Equipment (Subpart D).
     Any automatic, mechanical,
in the generation, measurement,
equipment used for
                                or electronic equipment used
                                or assessment of data, and
                   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 1s required to have standard operating
procedures (SOPs) in writing that set forth study methods
adequate to ensure the quality and integrity of the data generated
in the course of a study.  Any deviations must be authorized and
documented.  SOPs are required for most facets of a study.
     (6) Test and Control Substances (Subpart F).

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

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                               -5-                  -

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

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


     (7) Study Protocol  (Subpart G).

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


     (8) Records and Reports (Subpart J).

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


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

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

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

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                               -6-
Enforcement
Objective

     The objective of this strategy is to maximize compliance
with the 6LP 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.


Violations

     Generally, the failure to comply with any requirement of the
6LP regulations is a violation of those regulations (see Speci fie
Requirements of the GLP Regulations, above).  However, violations
are actionable Tna di fTerent manurer 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  J
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
or marketing permit, or denial  or disapproval  of an
for such a permit under Sections 3, 5, 6, 13,  or 24
   a research
application
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.
Inspectio n Scheme

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

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                               -7-                    '

that are subject to the 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.?y-oriented 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 accomplisherl  by examining raw data and other records
generated dur-ng tf*e  study and comparing them with results provided
in the study report.   Data audits will  be scheduled and carried
out by OCM, with necessary assistance provided by FDA, NTP,
Program Offices, and  the Regions.

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                               -8-                      

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


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

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

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


Violation Detection Priorities

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

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                               -9-                  


Administrative Considerati o n s

     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 1aborato-iest consistent
with resource allocations.  They will also serve as expert
witnesses in support of Agency litigation efforts.

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                        INTEKAGENCY AGREEMENT
                               BETWEEN
               THE U.S.  ENVIRONMENTAL  PROTECTION  AGENCY 
              OFFICE  OF  PESTICIDES AND  TOXIC SUBSTANCES
                                 AND   .                      '
           THE  U.S.  DEPARTMENT  OF HEALTH AND HUMAN SERVICES
                     NATIONAL TOXICOLOGY PROGRAM

 1.   PURPOSE
      This  agreement  provides for cooperation between the National
 Toxicology Program  (NTP)  and the Environmental Protection Agency
 (EPA)  in the  areas  of inspector  training, inspection operations,
 data  audits and  information exchange.  This cooperation will
 enhance the EPA's mandated activities designed to determine
 whether laboratory testing was performed properly and in compliance
 with  Good Laboratory Practice  {GLP)  regulations and whether the
 test  report can  be fully  validated through audits of the raw data
 generated during  the testing phase.
      The primary purpose  of this cooperation is to utlize NTP's
 experience in  conducting  and reporting laboratory GLP inspections
 and data audits  to enhance the training and capabilities  of EPA
 personnel  in these activities.
 2.  SCOPE  OF WORK
     The Environmental  Protection Agency (EPA)  is responsible
 for setting tolerances  for pesticide  residues  in  or  on  raw
 agricultural  commodities  and processed food under the Federal
Food, Drug, and Cosmetic Act {21  U.S.C.   346 and  348) and for
 registering pesticides  under the Federal  Insecticide, Fungicide,

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                               -2-
 and Rodentlcide 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 6LP  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 ';he 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.   Trai ning  -  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 ? -spect  a  testing laboratory  or complete a
 data  audit because of the lack of specific expertise.  CMS will
 provide  the  -equerted 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 La boratpries 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 da*ss of the inspections and  the  EPA
 scientific  personnel  who will participate in the inspection
 or audit.   Tris information will be classified  as  "For Official
Use Only" and shcjld  not  be disclosed except on a  need-to-know
 basi s.

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                                    -6-
      EPA  will  identify  for NTP those inspections where assistanc
 is  requested  from.NTP  and provide NTP with a clear definition b
 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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r
                                             -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,  19B4,
 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^i  is  necessary under this agreement.  Each
agency will fund its part of cooperative actions.   EPA  will fund
travel and travel associated expenses of NTP personnel  requested
to participate  in EPA activities described  above.

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                               -9-
9.  AUTHORITY
    APPROVED AND ACCEPTED FOR
    THE ENVIRONMENTAL PROTECTION
    AGENCY
    BY:
       77
       ih)hn A.  Moore,  DVM
    TITLE:   Assistant  Administrator
             for Pesticides  and
             Toxic  Substances
                                                                        1
APPROVED AND ACCEPTED FOK
THE NATIONAL TOXICOLOGY
PROGRAM
   David P. Rail ,  MD,  Ph.D
TITLE:   Director
    DATE:
DATE:

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                     MEMORANDUM OF AGREEMENT -
                             BETWEEN
                 THE COMPLIANCE MONITORING STAFF
                THE OFFICE OF TOXIC SUBSTANCES  AND
                 THE OFFICE OF PESTICIDE PROGRAMS
         IN THE OFFICE OF PESTICIDES AND TOXIC  SUBSTANCES
                    FOR A MANAGEMENT FRAMEWORK
                        FOR THE CONDUCT OF
              LABORATORY INSPECTIONS AND DATA AUDITS
1.  PURPOSE AND PRINCIPLES
     A Laboratory Data Integrity Program (LDIP)  has been  estab-
lished within the Compliance Monitoring Staff (CMS) of the Office
of Pesticides and Toxic Substances (OPTS).   LDIP is specifically
charged with developing and conducting laboratory inspection
and data audit programs to assure the reliability and  validity
of data reported to EPA under both the Federal  Insecticide,
Fungicide and Rodenticide Act (FIFRA) and the Toxic Substances
Control Act (TSCA) Sections 4 and 5.   This  Agreement establishes
the matrix management framework under which CMS, the Office  of
Pesticide Programs (OPP) and the Office of  Toxic Substances
(OTS) will work cooperati - 3ly to assure an  effective laboratory
inspection and data audit program.

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 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,  a: all  testing facilities performing studies to be
presented  to the EPA to  meet  requirements of both FIFRA  and
TSCA and (2) to audit fully  all data supporting the results of

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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 6LP 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.  Comp1iance Monitoring Staff
          (!) 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 OPP 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 dupllcative 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  o1
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 deliverables sent by  test
Sponsors to EPA Product Managers and enters dates  of  deliverables
into the data file.  The deliverables themselves are  directed
to OPP or OTS by the Sponsor,

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         .                      -5-
        (5) Notifies OPP or OTS Product Managers  of "schedule  devia-
tions and refers to CMS evaluations -by OPP or OTS scientists  of
deviations as well as recommendations for action.
        (6) Receives notices of sponsor-requested protocol  changes
and refers these requests to the  OPP or OTS Product  Manager for
evaluation and recommendations.  Refers these evaluations  and
recommendations to CMS for communication to the Sponsor.
        (7) Maintains security as needed on all reports,  schedules
and data files under its control.
        (8) Within the constraints of available resources  selects
laboratories for inspection and studies for audit based  on  the
neutral administrative schemes and selection criteria of CMS  along
with target lists and selection criteria supplied by OPP and  OTS.
        (9) Schedules data audits and laboratory GLP inspections
for health effects, for ecological effects and chemical  fate
studies.  Coordinates the audit and inspection schedule  with
FDA, EPA Regional Offices and with OPP or OTS scientific support
staff as necessa'ry.
        (10) Receives inspection and audit reports from  FOA 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 LOIP 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 LOIP 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-
lished criteria.
          (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 foon^or and the testing laboratory  before inspections
and audits are undertaken.

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                               -7-
          (5) Within resource constraints designate  appropriate
scientific staff to accompany FDA and EPA inspectors  on  GLP
inspections and study audits as requested by  LDIP.   Staff  scien-
tists may participate in routine inspections  and  audits  as recom-
mended by LDIP, and will participate in inspections  and  audits
where violations are suspected by CMS.
          (6) Provide LDIP in a timely  fashion  with  review and
assessment of Sponsor-initiated protocol  changes, test  laboratory
schedule changes and any other study-related  information from
either the Sponsor or the testing laboratory.
          (7) Provide LDIP in a timely  fashion  with  regulatory
significance reviews of GLP inspection  and data or  study audit
reports including an assessment of the  impact  of  inspectional
or audit findings on the study itself.
          (8) Recommend, to CMS and LDIP, specific  criteria  for
"for-cause" or "priority" GLP inspections or  study  data  audits.
          (9) Regulatory decisions (registrations,  cancellation,
suspension, rule-making, etc.) are the  responsibilities  of the
program offices; enforcement responses  (stop-sale,  civil complaints,
etc.) are the responsibility of CMS.
     d.  The Laboratory Data Integrity  Panel:
          (1) Serves as a steering committee  to ensure that  EPA
committments and objectives on LDIP are implemented and  met.
          (2) Serve? 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  (GLP)  Inspection - The authority
for GLP inspections is contained in 40 CFR Part  792 (TSCA) and 40
CFR Part 160  (F1FRA).  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 FOA.
     Other  definitions pertaining to  studies and to  GLP are con-
tained within the GLP  regulations.

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                               -10-
6.  CONCURRENCES
    V
                                               .V * V
    ^-A.
        Moore, D.V.M.
Assistant Administrator
for Pesticides
and Toxic Substances
Date
                                                O
Don R. Clay, Dired
Office of Toxic Substances
                                        Date
Edwin L. Johnson, Director
Office of Pesticide Programs

                                         Date
                                           go
A. E. Conroy/I I ,| Di rector
Compliance Mbnitbring 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
Fecjera| insecticide, Fungicide,
and Rodenticide Act
Compliance/Enforcement
Guidance Manual
Policy Compendium
Volume 3:   FIFRA Compliance
Monitoring Strategies

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

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

       Director, Policy and Grants Division
       Office of Compliance Monitoring (EN-342)
       Office of Pesticides and Toxic Substances
       U.S. Environmental Protection Agency
       401 M Street, S.W.
       Washington, D.C.  20460
                    Volume 3:  FIFRA Compliance Monitoring Strategies
                       TITLE                                                    DATE

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

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

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

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

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

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


                       TITLE

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)
         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
Guidance Manual
  November 1990

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

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

Clarification of Heptachlor/Chlordane Suspension Order

Status Report on the Heptachlor/Chlordane Suspension

Heptachlor/Chlordane Suspension Order Enforcement Strategy

Heptachlor/Chlordane Suspension Order Enforcement Strategy-CORN USE

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

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


Chlordimeform

Chlordimeforra Strategy

Final Compliance Strategy for the Cancellation of Chlordimeform


Compound 1080

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


                                      01/22/76

                                      02/19/76

                                      03/23/76

                                      08/27/76

                                      11/23/76


                                      04/13/88
                                      02/09/89

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

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Volume 3
                             Table of Contents
               Volume 3:  F1FRA Compliance Monitoring Strategies (continued)
                       TITLE

Daminozide (Alar)

Final Compliance Monitoring Strategy for Daminozide (Alar)

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


DBCP

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: FJFRA 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
                                      DATE



                                      10/20/86

                                     06/14/89
                                      11/07/79
                                     10/07/86

                                     04/02/87

                                     04/17/87

                                     03/14/88

                                     03/28/88

                                     06/15/88

                                     03/03/89
Compliance Strategy for the Cancellation and Registration Amendments for Pesticide
Products Containing Ethylene Bisdithiocarbamate (EBDC)
                                     03/12/90
FIFRA Compliance/Enforcement
Policy Compendium
iv
Guidance Manual
  November 1990

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Volume 3
Table of Contents
               Volume 3:  F1FRA 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
2.4.5-T and Silvex

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

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

Further Guidance on the Cancellation and Suspension of 2,4,5-T and Silvex
        03/07/79


        04/05/79


        08/20/79
FIFRA Compliance/Enforcement
Policy Compendium
Guidance Manual
  November 1990

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Volume 3
                            Table of Contents
               Volume 3: F1FRA Compliance Monitoring Strategies (continued)
Toxaphene

Toxaphene Cancellation Compliance Strategy
                                                                                DATE
                                     01/01/83
Wood Preservatives

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

                                          M
FIFRA Compliance/Enforcement
Policy Compendium
VI
                            Guidance Manual
                              November 1990

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     ENFORCEMENT ?AGTS
       AKD STRATEGY

        COMPLIANCE
   MONITORING PROCEDURES
WATER PURIFICATION DEVICES
       October 1930
              Pesticides &  Tcxic  Sucstances
                   Enforcement  Division
                   Office  of  Enforcement
           U.  3.  Environmental  Protection  Agency
                  Washington, D.  C.   20460

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     STRATEGY OVERVIEW -	1

     BACKGROUND	2

     ?.I:-V1ATSD INDUSTRY	;	3

     APPLICATION OF FIFRA	4
        Requirements of FIFRA
        FIFRA Snforoenent Authorities

     ?.2"EDIES	6
        General
        Mi soranding Purifier Claims
        Ineffective Water Purifiers
        Recall
        Other Violations of ?IFRA
        Crininal Citations

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

     CASE DEVELOPMENT	U

     ALLOCATION OF RESPONSIBILITIES	,-15

     ENFORCEMENT FACTS AND STRATEGY	19
c

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S tr?.r?*y Over view
_..,.-> 4
iis
vir
tra
on 
wit
and
       ter purifiers are products which are intended to render
       er s-ife to drink by removing pests (microorganisms) through
       chemical or physical means.  Water purification devices
       te peats (microorganisms) from water by using a physical
       such as ultraviolet light, filtration, or other non-chemical
        To qualify as a "purifier", the product oust remove all*
        causing microorganisms from the water, including bacteria,
         and cysts.  Since devices are not subject to the regis-
   *" a
   ..3 
   ease
   uses,
    ion requirements under PIFRA, regulation of them falls entirely
    he Office of Enforcement, which must determine if they comply
   h th
    Rod
   plia
       e other requirements of the Federal Insecticide, Fungicide,
       enticide Act to which they are subject.  The key to the
       nce determination will be verification of label claims
        a program of product testing.
 	_T_he ..testing program_will examine the purifier claim used by
~ar.r products.  If a product claims to be""a purifier b'uf'it does ~" "
not remove test organisms in the efficacy test, the product is
iee-ed to be misbranded and subject to enforcement action under
7I??.A, including Stop Sale Orders to remove the product from the
marketplace.  The testing scheme designed for this program consists
of two phases.  Phase I tests the ability of the products to
remove environmental coliforms.  Phase II tests specific bacterial,
viral and protozoan pathogens likely to be found in water such
as Pseudomonas aerogenosa, Poliovirus and Giardia lamblia.  To
substantiate a purifier claim, a product must
Th-"5, if it fails Phase I, enforcement actions
        spent ing time and money on the Phase
                                              pass both phases.
                                               will be taken,
                                             II tests.
     The goal of the program is to
prciucta which do not purify water
who night rely on tli
 - ** r- .3 i
                                   remove from the market those
                                   to protect the health of persons
                      products for safe drinking water.
 0

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

     Because purification of water involves the killing of micro-
 organisms, which are defined as pests in Section 2 of PIPRA, these
 products are regulated by the Environmental Protection Agency.
 There are two kinds of water purifiers:  Those which employ a chemical
 means to purify water, and those which use a physical method.  While
 both tyTjes are subject to the provisions of PI7RA, including but not
 limited'to, Sections 7, 8, and 12 as well as Section 2(p) and (q),"
 only ourifiers utilizing a chemical must obtain product registration
 a3"tTi'scribel" by "SectioS J Of the Act."- 'Jnder- Stlofl-25-ferU-)~of-	
 ?Ir?.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 red. 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 aopear on the label accepted by the Agency at the tine 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.

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

     The 2? A cannot require the manufacturer to substantiate tha
claims mad-2 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".eaci ng clainis.


                               -2-

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

     Almost any available physical  method that  eight kill a micro-
organism ia employed in  at  least  one  product.   The most popular are
ultraviolet (*JV) light,  aicropore filtration,  chlorine generators,
and ozone generators.  Ultrasound,  reverse  osmosis, electrolysis,
and distillation are other  known  methods  used  by purification
devices (See Appendix I).   These  types of devices are called "point-
of-use" treatment products,  since the water is  treated immediately
before use.  "Small systems" treatment products treat water intended
-for u.3-3 lr.-sma.ll. cjD.mmu,niJtj.fi.3-..--^2ji3.C3.;,ly_.^eyre,r_al taps__andr a_ dist_ri
cution network are part  of  the  system.   "Small  systems" treatment"
units are also regulated under  FIFRA  but  the quality of the water
produced is regulated by the Safe drinking  Water Act.   Since the
public is protected under another Act and the  resources of the Office
of Enforcement are limited,  these products  will not be tested as part.
cf this program.  However,  if such  products are found to be ineffective,
they may be subject
n fc->^'^o^^'
  ** W * \f v  v 
actions under FIFRA.
                               -3-

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                       r...-I
           FIFHA  and  its  implementing  regulations  clearly  apply to devices!
      The  requirements  of those  regulations  are  outlined below.  State
      laws  are  often  aabiguous 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 prograa.   State inspectors  who  nay 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
     ~FI??.A-r":th
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     For greater detail, consult 41  Pede. *1 Register 51055,
"oveaber 19, 1975.  nil requirenents of device producers described
in that document apply to producers  of water purification devices.
    *

FIFHA Enforcement Authoritieg

     Failure to adhere to any of the above requi renents .of FIFRA may
be an unlawful act under 12 of FIFHA as follows:

     'Failure to register the establishment [Section 12(a)(2)(X)]
     "Failure to keep books and records or to nernit inspection of
        books and records ("Section 12 (a)(2)(B)]
     Usbranding [Section 12 (a)(l)(F)]
     'Failure to file production reports [Section 12 (a)d)(H)]

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      C-gr.eral

           FITHA  provides  several remedies for violations of..its provi-
      sions.   If  the  purifier  efficacy claims are found to b.e 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 PIFRA 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 ?ederal  Trade Commission through headquarters.

      "isbranding Purifier Claims

           Water  Purification  Devices which  fail the purifier efficacy test
      are cisbranded.   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 continue'3
      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 Penaltv^must be assessed
      within fourteen days of  the Stop Sale  Order.  _

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

      Ineffective Water Purifiers


                                I      II      III      IV      7

      1.  Category A           5000    5000    5000     5000    5000

      2.  Category 3           1000    1750    2500     3200    4500
              See A. S. Cor.roy's Memorandum of September 12, 1930, "Interim
      'inal Regulation Section 13, ?I?HA."
c

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

Category  B  -  Products  in this category  passed  Phase I but failed
              Phase  II.   Since viruses and  cysts are pathogens as
              well as bacteria,  a health hasard 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"-ia'tO''c'Ott?l-laTnrer*trl-feh-th'-ATit-.
              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  "modified11 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
 sermit  G.  Iambiia cysts  to persist in water.   Since the cysts are
 relatively large, a ore-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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      Cther Violations of ?I??.A

          .As described in the section on the Application of PI?RA,
      the Agency has authority to take enforcement action when
      provisions of FIFFvA are violated.  Violations which do not
      involve the purification claim (e.g. violation of Sections 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 FIPRA which
      do not include the efficacy of the product are taken before  the
      efficacy tests are complete, the complaint or warning should
      clearly state that additional action nay be taken if the results
      of the efficacy test should prove to be unsatisfactory.  We  recom-
      mend that all civil actions be initiated at the sane time.


      Crisi-flal G-l-te-tion-g- -------- -- ........ -- --  .......    ....... -  ..........
           Willful violations of ?IFRA nay justify the filing of
      original charges against a nanufacturer.  PTSED concurrence
      would be required for criminal actions.
c
-3-

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           /fven. below are procedures for the compliance monitoring aspects of ths
         jgram with description of responsibilities and data flew
           7: delir.es for Selection of Devices To Be Tested
           *
               M3-?T3iD will select the devices to be tested and determine the
              order cf 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 helo determine the order
              of tsstirj:.

              -  The first category, vfcich 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 complaints, scientific judgment based
                 on the study cf product design, and failure of the
                 device in similar tests.

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

              C-3-PTS3) will prepare the sample request forms and  forward
              then to the appropriate Region" for collection.
           inspection

              At the opening conference:

              -  The inspector should request efficacy data fron the
                 manufacturer pertaining to his/her device(3).   The
                 manufacturer canr.ct however, be required  to submit
                 this data.

              -  The inspector should advise the raarufacturer that
                 his/her product is  not  being singled  out  for attention.
                 The collection cf his/her device is part  of a  nationwide
                 effort  to  test water rsurificatior.  devices.
c

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       *  Inspection of boots and records will be perforasd in accordance
          with the Pesticides Inspection Manual for the purpose of deter-
          aining compliance with the record keeping requirenents (3).
            *
 (      *  An official sample of the device will be collected at the producer
          establishment according to the Pesticides Inspection Maruai.   The
          official sa-ole will include labeling (including instructions 'for
          installation) and all other documentation as required (notice of
          Inspection, Receipt for Samples, etc.).

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

          -  Because many of these devices are very expansive, the .
 	 -	inspector... sliould.naks.,an.. atessrt;._.tP._.have. Jjie..mamf acturer
             donate the device,   y.any manufacturers have already
             indicated a desire to have their devices tested, and
             a willingness to donate then for this purpose.

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

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

       *  If the T^irufacturer requests to install the device himself,
          arrangements with the testing laboratory should be cade
          through CT-S-rTSE).

       "   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 sanple
             can be obtained.
      / Barlow's Decision:   Guidance to Re-*ional Personnel:   Conduct
  :f Inspsstiors  after the Sarlcw's Decision (April 11,  1979)
C
-10-

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           If a product spjsple obtained froa the zarketplace
           fails the efficacy tests, a warrant  to conduct  an
           in-depth bocks and records inspection may be
           obtained.  This will be necsssary if production
           and distribution data is needed,
III. Pest Inspection
        When the requested.aaaple has been collected,  the "PRD
        Ackr.owledgnent" copy of the saaple request form will be
        forwarded to CI-3-PTSHD with the "Sample Identification"
        section completed.

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

        -  A second copy of the device's labeling is to be assembled
           by the inspector and forwarded to CM3-PTS33 for contract
           raanage^ent purposes.
     Testing

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

     "  Zach device will be examined when received by the laboratory
        for arr,' possible defects resulting from shipment.

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

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

        -  All failures will be confirmed by a second test

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

        -  Enforcement action will not be initiated unless both
           samples fail

     '  The testing laboratory will be subjected to a Quality Assurance
        (QA) Performance Audit and a OA Systems Audit.  These audits
        will be initiated by ??S3D.

     *  The testing laboratory will submit to O3-PTSID  a QA Prcgraa
        and Project Plan.
                                       -11-

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        *   CM3-PTS3)  is  to  be kept  informed  of  the  testing status of the device.
           This  information is  to include:
  f """          i
 <         -   date  the official sample was received

           -   date  testir.g  was  initiated and completed

        *   V,"nen  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 jaclets will go directly to the appropriate
             Region  frcm the testing laboratory for review to determine
             violations, and to initiate enforcenent action.

       *  -  A copy of  the test results will be forwarded to CM3-PTSH)
              fron  the testing  laboratory to monitor the contract.

       *  The testing laboratory will retain all devices for which
          violatiors exist until enforcement action is completed
          or the case is placed in permanent abeyance.


  V.   Pesticide Zr-fcrceaer.t Management System (PS
       The Regions will keep PTS3D informed as to the enforcement statas 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 PEM3 Cccputer system.
  ^ ~
       Outreach
       v^rr/ .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                j
  their trade associatior^ has been prepared (Appendix IH-)C>                            v

       Ths responses free this letter will allow the Agsncy to cccpile an
  accurate list of carufacturers, their products, and production and distri-
  bution data.

       A press release has also been prepared announcing the program to the            ./
       c and notifying industry of the establishment registration requireisnts         "
  (Appendix ^A

       As a result of this oatresch pro^raa, 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 CT-S-PTS33, Cocp" lance Monitoring
  Coordinator.
c
-12-

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         Microbiological  data generated  by this prograa will be  submitted  tc  the
   Journal  of Applied  and  Environmental Microbiology for  pjblication after the
   enforcement cases are ccnpletei.   The results of  the tests may also  be
   -^resented  at  the \*2. 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.  Cocaittee on Water Microbiology of the
    American  Society  for Testing Materials.   It  is possible that presentations
    will  be nade  to these groups.

         Regions  nay  release information concerning individual  cases in the saae
    manner that such  information is  handled  in other civil proceedings.
c

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

                                                   o requests  samples
                                                   o monitors  program
                                                                  sample
                                                                  request
                     r.otification of
                     action taken
                  Region
       o reviews lab's report, labeling
         and any records collected to"
         determine possible violations
       o cerercir.es er.forcer.ent response
         and initiates action
       o maintains official enforcement
         file en devices
                                                        Region
                                           o sets up enforceaent jacket
                                           o collects samples, performs
                                             inspections
                                           o sends PSD Acknowledgment to
                                             CMB-PTSED
                                           o sends copy of labeling to
                                             CMB-PTSED                :
                                                           sample &
                                                           enforcement jacket
                            test results
                         enforcement jacket
                  test  results
                                     -13-a-

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      Case  development  will  proceed  in accordance with  the  Case
- ?rcc?-?dings  Manual.  The  Regions  are  aivised  to avail  themselves
  ;"  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  b'oth
 chemical and physical  water purifiers and the data on  produtt
 performance  from  the efficacy test.
     Please  note  that
the Stop Sale, Use  or
efficacy tests.
a civil complaint should be issued along with
Removal Order when the product fails the

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     rr.is_cr.art _is a_gaiie to the responsibilities _i or the different tasks ln_ta_e_vater_
     rurification device enforcement rroffras.
                Heajauarters (PTSZD)
                            Regions
          Identification of Purifier Devices

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

                *  Regions suinit inforcation on
                   ne*r products they bee one aware
                   of to Compliance Monitoring
                   Branch
     2.   Selection of Devices to be Tested

          '  Compliance t^onitoring Branch
             updates list of taown devices
             and selects devices.

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

          *  Caspliance Monitoring Branch deter-
             mines nazes and locations of device
             producer establishments:  assigns
             Inspections to appropriate Regions;
             prepares sazple request for^s and
             sends then to Regions.
G
           4.    Inspections and Saarile Collection

                0   Regions assign inspectors to
                   conduct establishes.it and/or
                   bocks and records inspections
                   and product  sample and docu-
                   mentary material collection.
                   (inspections aay be aade by
                   Federal or State inspectors.)

                e   Inspector performs inspection
                   according to PIFRA procedures
                   and guidance;  special instruc-
                   tions aay appear on the sanple
                   request fora.
-15-

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               Headrjiarte rs  (FT3ZD)
            Region
r
   Inspector ships saaple(s)  and
   one set of documentary ca
   to testing laboratory,  ser
   copy of documentary sszple
   headquarters,;
         Testing of Devices

         '  Laboratory  (Snvironnental Health
            Center, State of Mew York, Depart-
            ment of Health, Albany, N.Y.)
            performs efficacy test according
            to PTS2) approved protocol; furnishes
            results etc. to PTS2D and the
           SvegiOT-. (See *U3.-below..) The .lab  	
            will keep the device until litigation
            is
         Determination of Violations

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

"  Region reviews inspection data
   and its set of documentary
   material to determine existence
   of violations under PIFRA
   Sections 7, 8, or 12 as well
   as well as Section 2(q)
   branding violations.

*  The regions are strongly
   advised, particularly early  
   in the program: to send the
   jacket to headquarters for a
   pesticide Snforcersent Review.
   The reviewers ccopare testing
   results agiinst label and
   advertising claims to deter-
   mine if purifier claims are
   false and misleading (misbrand-
   ing violation).  N.B.  The
   enforceaent jacket acconcpanies
   the sample to the laboratory.
   The laboratory inserts the data
   from the testing program and
   forwards the jacket to P.egions
   which nsy for/ard then 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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        Healriartgrs (PT5ZD)
                 Regions
                                                      Based on the laboratory's
                                                      determination, the Regions
                                                      cay initiate action on the
                                                      purifier claim.  This should
                                                      not preclude discussion of
                                                      the case With headquarters.
 Determination of Appropriate
 Zr.forcemer.t Response

 *   If misbranding violation based on
    the purifier claim lias occurred,
    headquarters may provide additional
    information based on historical files.
	A-r~rcpriate- records and recoursendations
    will be forwarded to the Regions.  If
    advertising is seriously misleading, a
    referral to the Federal Trade Coamisaion
    will also be made.
7.   Deteraination of Appropriate
     Enforcement Response

     *  A Stop Sale, Use or Removal
        Order (SSUHO) will be issued
        for all products -which fail
        efficacy test.  A civil penalty
   	is. alspj
        Region applies general ?I?EA
        civil penally policy and
        satrix to deteraine appropria':
        level of actions for ail .
        violations.
  Zriforcerer.t Actiorys,  Litigation,
     FT SID  ^,-(  ur.de r exceptional
     circumstances, initiate
     enforcement actions.

     Sections of the agreements
     which  irr/olve label or product
     improvements to bring the product
     into conpliance are to be sent to
     PT3-D  for concurrence.
S.   Enforcement Actions. Litigation,
     Settlement
        Regions will initiate
        enforcecsnt actions
        (warning letters, civil
        complaints, SSURO's).

        Region may obtain expert
        testimony fro~ headquarters
        reviewers or laboratory
        scientists.
  Completed  Case Files

  *  PTS3D will caintain a file
    of  all  test data results and
    copies  of 7inal Orders for use
    in  dcc-a.tr,-?ntir.g the possible need
    for regulatory or legislative
    changes.
9.   Conpleted Case Piles

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

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

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                 Eeaisuarters
                                                                        Regions
       10.   Publicity.
r
                                          10.  Publicity
Sta
       of Program
 - Press Release
 - Letters to raanufacturers and
      trade associations.

 Release of data generated "by
 testing prograi.   (Laboratory and
 Compliance Monitoring Branch)
 - Publication of Scientific data
      in appropriate journals
 - Presentation in  proper foruas.

 Consumer Information detenained  as
._a ..result af_..ths-.wbale_..prQSPsp __________
 - number distributed
 - type of use/risk factor
 - conclusion to be drawn from the
   program.
Release of information
individual cases in the
manner as' other pesticide civil
cases.     *
                                              -18-

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    reesent Facts and Strategy
      *
^^..dix I:   Types of Purifier Products
ppendLx II:  Legal Definitions,  "Purifier" and "Device"
    niix III: Pub licit? and Outreach
20
22
33

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                                                              Aendix I
Water purification devices employ a variety of techniques to purify water.
ost cccasn techniques are:

*  Ultraviolet light - Light of wavelengths around 260tn danases the KIA
   of exposes organisms. ~If the exposure tine is sufficient, the orsnisrs
   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-
   coles.  Zfficacy of this cethod depends heavily on the engineering of the
   whole system.  The protocols used by the Canadians are the basis of the
   screening phase of the TJS SPA Water Purification Device Testing Protocol.
   Duplicate ve verification of results on the saz& types of products used
   to develop the protocol is useful to the U.S.  and Canadian Enforcement
   Programs.
   3ub-icron 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 zake purifier claims.  Unfortunately,
   a very large virus would be only 0.1 micron in diaaeter and soas bacteria
   are capable of changing shape.  The filter would consequently not work.

   Ultrasound - High frequency sound causes pulse waves to form in water.   The
   rapid changes in water pressure result in "shearing forces" which- cause
   bacterial cell walls to break.  This technique is used in a research setting
   to avoid chemical denaturing of macrcnolecules and cellular orsanelles.
   Whether it would be eff icent on the scale necessary to purify water is  un-
   known.                                                                    A

   Chlorine generators -  These devices electrolyse salt (NaCl) to fors chlorine.
   The chlorine acts as a disinfectant to purify water.  Tnese products are devices
   and not chssical pesticides because the product which enters channels of trade
   is not a chenical".  The consumer generates the pesticide at the site of use
   for his OV.T* use ani not for sale or distribution.  Unfortunately, since there
   has been virtually no regulation of these products, the label directions say
   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 miniaua contact time would ensure a reasonably-
   pure water.

   Csone generators - Oxygen from air is electrically ionized to fora ozone,  a
   powerful oxidizing a^nt and disinfectant.  Unlike chlorine, ozone* does  not
   persist (it rapidly decomposes to oxygen) and cannot be easily ceasured.  It
   is difficult for consuosrs to know if the device is actually working or  if
   sorse sinor product failure has resulted in lower levels of ozone production.
   Installation is complex - often done by the seller - and cheaper products
   -ay be unsafe electrically.

   ZLectric current -  Presumably the raic reorganises are electrocuted by the
       -a^ of an electric current throu.^. a water reservoir.
   Distillers -  These products ccnder.se stesm from boiled water.

                                 -20-

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

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

        Two tyres of products which are labeled as water nurifers will not be
   tested:

        *  Potable v*tr "rurifers" - Theso products use the term purifier on
           their labeling "OUT are clearly intended for use on water that
           is already potable (i.e., faucet "purifiers" for use on municipally
           treated water), "ariifacturers of these products should be warned
           that use of the term "purifier" is for products which process
           untreated water.  (See 4.1 Federal Register 32778, August 5, 1S75)
           Other enforcement actions may also be necessary.

        *  large Jgurifiers which treat water for groups of twenty-five persons_
           or sore.  These products are regulated by FI7EA.  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 Enforcement are limited, these products will not be included in this
           program.  (These are also known as "small systems" purifiers.)
I.
-21-

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                                                             Appendix II
                   Legal Definitions, "Purifier" and "Device


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

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

"  '"  2.  Guidelines for Registering 'Pesticide-Products-i-n-the United -States-  -
          Section 3:  Product Performance Standards for Water P-urification
          Devices.

      3.  EPA ruling In re Contact Industries, Inc., I.P. & H. Docket tlo. II-?36
          (1973) pg. r.

3.    Devices

      Pest Ccntol Devices and Device Producers; Consolidation and Clarification
      of Reouirersnts. rederal Register,~ vol..' 41, no. 225 Ul/19/1976).
                                       -22-

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           1 ; -v. J
    
 
.at   a 7.    (Fun  zszz available
                          IN THE "MATTER OF 

          SIECO PRODUCTS COMPANY) ixc., ET. AL.

   GROSS, OPINION, ETC., IN BECABD TO THE ALLC0 VIOLATION OE
                   ^ FEDERAL TBADE COMMISSION ACT       '  "
  *'" ^ * ?oe*el 5WS- Complaint. Juni d. f ^/fccuio/vATw. 22. IMS'
  .Order requirir.y a" N*w Jersey manufacturer' df" water" Yilba tor* to
  X,*.xm?repre?enfc3S the etivr- a-'d capability of itj water filtration
  i.- uutJ aad deceptively guiranuetag the perfonaajica of di unitt .
                                                 f  .      -317

      i                      -tOpiaion
      Implied ..Representeiiona -Respecting ~~Micro--organisins"*and
   Complaint counsel charges that by the use of such words as'"ptfre,"
 "purify" ajid "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 cade 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 at-
 Jeged in their answer  that  the  literature accompanying the  unit
 contains a specific disclaimer thit 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 lettersthat their  unit
 will/'purify and filter"  tvater, 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 supplyconstitute 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 Jby statements  of  the type  quoted above to believe
 that respondents' unit  will make  his water potable. _G/a/:_t_Foqa's,
 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' prospective  customers actually received  this pam-
 phlet. Furthermore, this difc!.-.:.T.er was  not inserted  until respond-
 ents' precoraplaint negotiations with complaint counsel. Finally, the
 presence of  this riiaciaitEcr  '.   ::o of respondents'  brochures does
 not negate the cor.::nry irr.r    :-:\  ir.  the affirmative representa-
 tions con wined  in  choir auv>  . .'Jior.to and sales literature as to
 the purifying  qualities  of  tlu:': unit.

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     -.-5
"  -avai
                                Guidelines  fcr Registration -of  Pesticides  ;
Ur,i:as  2:2:25: rrccuci Perron  snca  Stancartis (pg  145-146).   (Full  text
              elements:  representative  levels  of organic1 and Inorganic soil


              contaaination;  various  water  tesrperaturas; the specific dcsage
                          * *
              aad exposure  period  recocaended  for  the proposed produce; a


              variety of test oicroorganlsss representative of Che Cargec pests

                                                                  ,t
              to be controlled;  aad quantitative detersisation of the level of


              microbial  contssination of  the vater before aad after treacaent.


                (li)  Performance  stasdard.  The treataeac oust eliminate all


              test cicroorgaaiscs  frcs  the  water.


                (3)  Vater  treatreat  usit_s  (i)   Water  curifisr usits.  Asy unit


              intended for  the  treataent  of raw water to elinicate the potential


             ' health hazard posed  by  oicroorganisas  is identified as a eater


              purifier.   The unit  nay rely  on  physical filtration,* (pesticidal


              device), or cheslcal treac=eat (pesticida), or a coobinatica thereof,


              to achieve the intended purpose  of purifying nicrobiologically ncn-


              potable vater by  elininating  vatar-borre pathogens in the water


              itself. Those units, such  as subaiczon nesbranas and absolute filters,
                                                            

              which rely solely en a  phjsical  neans  for  resoval of =icreorganises


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


              to regulation but not registration.  The test rei^uireaents indicated

              below are  for the units containing an  antimicrobial agent.


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


              water purifier ur.it  cust  be conducted  under conditions representing


              actual use ezploylug a  defined raw water source containing a high


              level of aicrabialogical  pollution.  The tast design wil  vary
                                           145

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C
           with different  types of units and patterns of use, but oust include


           uch basic elesenta as: representative levels of organic an4 is*
                         * 

           organic soil contamination; various water tesperatures; docisen-


           tatioa of the antimicrobial concentration found in the test system;


           and quantitative deterainations of the oicrobial eoataaination


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


           duration of effectiveness or effective capacity of the unit before


           a replacement is necessary aust be doct=aented 


             (B)  Performance standard.  The treataest oust elisiaate the


           cicrobial pollution in the rav vater.


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


           ical and/or chesical traacnent of sicrobiologically potable vater


           fron a cusicipal treacsest facility to resove undesirable tastes


           odors, cheaicals, or other aesthetically objectionable properties


           id Identified as a potable vater treatment unit*  A substrate such


           as activated charcoal (vith or without a bacteripstatic agent) is


           incorporated into the unit for this terminal processing treatment


           of potable water prior to consumption.  Since the requirements of


           the Safe Drinking Vater Act do perait ausici?ally-treated drinking


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


           vhich are cosaonly recognized coccaaisants of vater, an antimicrobial


           a^enc is scaetines incorporated in a potable vater treatment unit


           to provide bactarioscatic activity against these contaninants.  Only


           potable vater treacsect units containing a bacterlostatic agent are


           urder the purviav of the Act.
                                           146*

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."Exerpt  fror, In re Contact Industries.  Inc. (pg. 6-8).   (Full  text of document
.available  from headquerters.)
                      ENViRO;j::r.;nAi. PROTECTION AGEKCY
                     BEFORE THE: REGIONAL ADMINISTRATOR
     In re
            Contact  Industries,  Inc.,
                          Respondent
I.F. & R.  Docket No. II-1S6C
 '   . Initial Decision
           The term purifier connotes a  product which  eliminates  impurities
      and polluting ratter.  We are  in agreement with  the  conclusion  of
      Complainant's export witness that  the  "word  purifier is  sufficici'-'Hv
      broad to include ridding the air of  nb.icctionables,  including nirrn-
      orgsnisr.15 as they would exist."  An  air  purifier would therefore
      clesnse the air of air-borne b?.cteria, virus,  and fungi  particles.   If
      Respondent had intended for the product  to b3  understood to be  merely
      an air freshener or deodorizer, the  label could  have contained  the
      terni air freshener (cf. Respondent's Ex. 7)  or been  limited to  the
      claim that the product was an  industrial odor  aLisorbant  and nbt also
      a glycolized air purifier.  In fact, the latter  phrase would bs
      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  en air freshener.   As  indicated  by
      Complainant's expert witness,  the  term air purifier  especially  when

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                          .   - 7 -
taken toother vvith the word "Sanicidc" on the label would indicate
that thu prc-Jjci is intended to rid the 
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                               - ti -

rc?.d.  Unit.Ld States v. Articles of Drug. Etc.. 263 F.Supp. 212 (0.
Neb. 1?G7).  Cf. He 1 hros totr|;i_ Co^p.iny v. Federal Trade Cnrrrnr.sicn,
310 F.2d 863, , 869 (D.C. Cir. 1952), cert, denied 372 IKS. 976
                                                          *
(1552), rehearing denied 374 U.S. 857 (1363), and cases cited therein.
A consumer would be justified  in believing that the product he purchased
had .ths capability of both cleansing tha area sprayed  (sanitizing) and
killing nicrcorgani^ms 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 glycolizecl air purifier.
Certainly, the use cf the prefix sani- with the suffix -cide has
greater significance than the  use of that prefix in other  contexts
disclosed  in the record.
     Antimicrobial agents are  specifically included as one of the
classes.of sanitizers or pesticides subject to registration under  the
act.   (See section !C2.3(ff) cf the regulations  (4G.C!Tv lC1.3(ff}}).
The claim  that the product Superior Saincide Air Purifier  is an air
purifier when read in conjunction with the word "Sanicide" would  indi-
cate that  the product is indeed an antimicrobial agent "intended  to
reduce ths number of living bacteria or  viable virus particles on
inanimate  surfaces, in water,  or in air", in  this case.  See 40 CFR
                                       J/
162.3{ff)(2)(i)(B) (Er.iphasis supplied).    Thus, representations made
     _!/  i'-Mcroorg'.:n::ii:,  inch-ding  but not  limited to a1g:.c,  fungi,
and bacteria, and viruses have  bcn declared  by  the Ad.iinis'Lratur  to
be posts \;!;cn tl-.cy '.::ist under  circumstances  that Make  tiiOii doletorious
to man or the cnvircracut (See  40 CKU 162.14(b)(4) and  (5)).


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        UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
 '                    WASHINGTON. D.C. 20450


                          JUN  8I9S!
                                                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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                           - Z .

     I am also attaching an amendment to the Guidelines for
Assessing C1v11 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,! Wrector
                            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

     Applicability
     Exceptions
     Exemptions
     Specific Requirements

REGULATED  INDUSTRY
ENFORCEMENT

     Objectives
     Voluntary Compliance
     Violations
     Inspection Scheme
     Violation Detection Priorities

ADMINISTRATIVE CONSIDERATIONS

     Program Management and Allocation of Responsibilities
     Program Integration

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        f o r_Jt n ?       --
lacjc a g t n g' Teg uTaTI on"Un d^ r' TTFfTA"
Overview
                                    c n * dRes
    On March 9, 1979, the Environmental Protection Agency
published a final  rule at 44 federal Register 13019 (40
CFR 162.16) which requires chifd reTistantT 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 for^residential use. (2) it Jias not
been classified for restricted use. a,nd (3) it meets certain
loxicity 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 PTSEO is required for enforce-
ment actions resulting from violations of the CRP regulation.
Headquarters support will be available for data review and to
answer questions on whether or not a product meets the criteria
that trigger the requirement for child resistant packaging.
In addition. PTSED will provide inspection targeting information.

Requi rements 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:

    0  "Released for shipment11 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 1s 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   "Toxicity criteria" are defined in 44 Federal  Register
        13019 (March 9,  1979) and at 40 CFR 162.16(C)(2).	
Exceptions toCRP
"Dormant" Product Registration

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

Toxicity Data

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

Products for Residential Use by a Serv iceperson

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 serv i cepersons .  To accomplish this, EPA will
allow products such as those listed above to be sold and
distributed without child resistant packaging if such
products bear a statement restricting the sale, use,
        t n
          n r a a e
                   ser v 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 Jirosecutorial  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.

     e    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 t^est  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.

     p    Amend reoistratinn  - Cep^: 1 f i r a t i on

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

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                       -5-
detailed Information demonstrating that the packaging
meets the requirements, the registrant shall include
with his application a certification that the package
meets the standards of 162.16(d).  An applicant for
a new registration shall also submit a certification
statement that the package meets the standards.
Utilize special packaging
Products subject to
resistant packaging
March 9, 1981.

Becordkeeoina
                    the requirement
                    if released for
must be in child
shipment after
Certain records must be retained by the applicant or
registrant for as long as the registration is valid.
These records shall be available, upon request, for
                              registration is
inese records snail  be available, upon request,  r
inspection and copying purposes or for submission
to EPA.  The records which must be kept are:

(1) A full description of the package including:

    (i)  A full  description of the container  including

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

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

         (A)  The name of its manufacturer,

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

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

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

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

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

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

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

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

Enforcement
Objectives

    The objective is
so as to minimize or
poisonous pesticides

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

Violations

        Misbranding - 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

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 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
              utilized).

         (3)  Company changes  packaging,  but it does
              not meet the child resistant  requirements
              because tests  were incorrectly done or  the
              tests were conducted on the incorrect
              container  size.
 Failure  to  File  Reports  Required  -  12(a)(2)(N) of FIFRA

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

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

Jiailure  to  Maintain  Reports Rp
-------
                            -8-


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

         ^j si f icatijon of Application/Report or of Records
         aintained^or 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
p o 1 i 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
criteria.

Priority 3 - Failure to File  Reports

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

Priority 4 - Falsification  of Data

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

ADMINISTRATIVE CONSIDERATIONS
PROGRAM  MANAGEMENT AND ALLOCATION  OF  RESPONSIBILITIES

     State  and  regional personnel  if  appropriate will be  responsi-
 ble  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

-------
                            -10-
status or the validit " of tho dat-i. dml r<>vifwin<] concurrent0
requests.

Program Integration

    The Case Development and Legal Branch, PTSF.D, 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 requ i percent s .

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           UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                          WASHINGTON, D.C. 20460
MEMORANDUM
                                                                  OFFICE OF
                                                          PESTICIDES AND TOXIC SUBSTANCES
SUBJECT:  Enforcement Strategy Concerning Child-Resistant Packaging of
          Pesticide Products.

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

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

Product

1.  Calcium
    hypochlorite
                    Concentration
                         65%
2.   Lithium
     hyprochlorite       35%

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

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

5.   Hydrochloric acid   8%

6.   Phosphroric acid    17%

     Chlorophenolics     61

     Sulfamic Acid       20%
7.

8.

9.
     Quaternary Ammonium
     Compounds
10.  Parafomaldehyde     95%

11.  Formaldehyde        37%
                                             Use
                                             swimming pool
                                             Swimming pool

                                             Toilet bowl

                                             R       n


                                             Disinfectant

                                             Toilet bowl


                                             General disinfectant

-------
2.
                 and Rodenticide
  Pesticide  Chemical

  1. Carbophenothion


  2. Chlordane


  3. Chlorpyrifos  (Dursban)


 4. Cryolite

 5. Diazinon



 6. Dimethoate (Cygon)

 7. Disulfoton (Disystox)



 8. Dyfonate

 9. Ethion


 lO.Imidan

 ll.Lindane


 12. Metaldenyde


 13. Mexacarbate  (Zectran)


 14. Naled

 15. Propoxur (Baygon)

16. Phosphorus (white)
                         % At and Above Requiring CRP
                                   1.4


                                   23.0


                                   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. Hejbieides and Fungisidfis

Che_mic_al                 Formulation / % A.I.

Bis  (tributyltin) oxide       Above 0.5%

Paraquat                      any %

Pentachlorophenol             above 88%

Chlorothalonil                above 40%

Copper-8-quinolinolate        above 5%
                                                        Use

                                                  Wood  Preservative

                                                  Homeowner  herbicide

                                                  Wood  preservative

                                                  Homeowner  fungicide

                                                  Hood  preservative
  to Engler,
Disinfectants Branch
Registration Division  (TS-767)


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

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

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

Requi rements7jg/Jlt_lie Ru 1 e                                            '
S u b n i s s j_o_n_o_f_ Ajs p 1 i c a t i p_n_s	
     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.

-------
             3)  If  necessary,  a  Statement of Confidential Formula  (EPA Form
                8570-4).
             Registrants must  normally  submit  applications within  60     ^P
        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 witli 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
mai'ntain the exemption from compensation requirements.
Combined Application in Response to MultlpieLabel Improvement
Notices
     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.

-------
       Types  of  Violations
            Producers  not complying  with  the  requirements of .the notices
                                                             tf
       issued  under  the  Label  Improvement  Program  are  in  violation of
       of  FIFRA  section  12.(a)(1)(E)  1n  that their  products are misbranded
       under  sections  2(q)(1)(F)  and (G).   Products  being sold in violation
       of  a  cancellation order  are  in  violation  of FIFRA  section l2(a)(2)(L)
       and subject to  the penalties  thereunder. -      -
      Ajjminisjtrat_1 ve  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) Termiticides  -  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.
c

-------
            4) Salt Water Emesi s  - Issued 11-30-80 - This LIP  Notice

       requires all registrants  to delete salt water emesis  statements

       from their labeling.   Since the revision was  a simple 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	^	


            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

       targetti ng.

             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
4
 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 RO.  Priority
                                                       d
for inspection should then be as'signed on the following basis:
     1) Registrants of products subject to cancellation for failure
        to respond to the LIP Notice.  These registrants should
        be ranked based on the number of their products subject to
        the LIP Notices in the following order:  Fumigants,  Termi-
        ticides, Antifouling Paints and Salt Water Emesis.
     2) Registrants with the most number of products with accepted
        amended labels subject to any LIP Notices in the following
        order: -Fumigants, Termi t fcTd'es"," "Anti fouTi rrg Paints  and
        Salt Water Emesis.
     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 Pesti ci des^T.
The highest priority in scheduling inspections should be given to
those producers which meet the largest number of these criteria.

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

-------
                                - 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,
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.

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-------

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

Dverview              	      '_      ....""        	     ''".  	    ~
     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 affect  all  registrants, while
others affect only registrants of certain products.

Requirements of the Rule'                                        .._._
Subm'ssion 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 nail  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 Formula (EPA Form
                8570-4).
                                                                        ^^k
             Registrants must normally submit applications within 60     ^r
        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 RO
        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 App11cation in Response to Multiple label Improvement
Notices
     Applicants receiving multiple notices requiring LIP labeling
amendments for the same product may combine responses into one
application for amended registration provided the relevant LIP
Notices are clearly referenced.  Applications that are non-compen-
sable under FIFRA section 3(c)(l)(0) may not be combined with
     /
applications that are compensable.  The submission deadline for
combined applications for amended registration is the later of
the deadlines established in the LIP Notices.
Time Frames for Compliance	
     Any product released for shipment 180 calendar days after the
registrant receives RO's acceptance of amended labeling must bear
that accepted label.   Registrants are responsible for compliance
by their sub-registrants (distributors).
     Products that have been released for shipment and are in
retail  channels of trade prior to the 180 day deadline may continue
to be distributed in  commerce, sold and used until supplies are
exhausted.

Enforcement Objectives                                           ~

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

-------
                                      . 4 -
      Type so f Viol at 1o n s
           Producers not complying with the requirements of .the notices
                                                            tf
       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)(1)(F) and  (G).  Products being sold in violation
       of a cancellation order are in violation of FIFRA section 12(a)(2)(L)
       and subject to the penalties thereunder. -       -     . -
                 x	
       Administrative Considerations	
           The Office of Pesticide Programs has issued four major label
       improvement notices  (See Attachments) which are  currently in effect
       with two more LIP Notices issued but not yet in  effect.  The four
       existing LIP Notices  are listed below in order of inspectional
       targetting priority  according  to their potential hazard.
           1) Fumigants -  Issued  12-4-80 - This LIP Notice  requires
       registrants of products containing certain active ingredients to
       add additional precautionary labeling, misuse statements and storage
       and disposal statements.
           2) Termiticides  -  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) Anti fouling  Paints  - Issued 3-9-82 - This LIP Notice required
       registrants of all antifouling paints to make extensive revision
       of their product's labeling.
c

-------
     4) Salt Water Emesi s - Issued 11-30-80 - This LIP Notice

requires all registrants to delete salt water emesis statements

from their  labeling.  Since the revision was a simple 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	^	
                                                          *

     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

targetti ng.

       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.

-------
                                - u-
to respond to the.LIP Notice; and b) label amendments RD has
approved.  Inspection priorities will not include registrants     ^B
whose products have label amendments pending with RD.  Priority
                                                       *
for inspection should then be as'signed on the following basis:
     1) Registrants of products subject to cancellation for failure
        to respond to the LIP Notice.  These registrants should
        be ranked based on the number of their products subject to
        the LIP Notices in the following order: Fumigants,  Termi-
        ticides, Antifouling Paints and Salt Water Emesis.
     2) Registrants with the most number of products with accepted
        amended labels subject to any LIP Notices in the following
        order: Futnigants, Terml ti~cTd~esy 'Anti fouTi n"g Paints  and
        Salt Water Emesis.
     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

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./-I
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 Respons i b iJities
       Headquarters Responsibility
        a)  Provide Regions with  a compliance strategy  for Label
           Improvement  Program,
        b)  Provide Regions with  copies  of each LIP Notice,
        c)  Provide list of registrants  affected  by a Notice,
           status of the products affected  and date of accep-
           tance of final printed labeling  for each product
           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.
t

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              UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                          WASHINGTON, D.C. 20460
                              SEP 3  1935
MEMORANDUM
                                                            OFFICE OF
                                                     PESTICIDES AND TOXIC SUBSTANCE*
SUBJECT:  Compliance Strategy for FIFRA 3(c)(2)(B)
          Suspenslons
FROM:     A. E. Conroy II, Director
          Office of Compliance Monitoring

TO:       Addressees
                                                     N,
     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
responses are
the draft compliance strategy and OCM's
f n 1 1 nui 
on
as follows:
     0 One Region requested that the three month period for
       conducting inspections for compliance with the Stop
       Sale, Use or Removal Order (SSURO) not begin until the
       States receive the information on the issuance of the
       SSURO.  The strategy has been amended to reflect this
       comment.

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

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

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

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

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

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

Attachments

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                                                        SEP  3666
        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
issued:

     0  chronic toxicological  data gaps,
     0  registration standards data gaps,
     0  special review data gaps, and
     0  others such as product chemistry data gaps, confidential
        statements of formula, or ground water data gaps.
REQUIREMENTS
     Section 3{c)(2){B) of FIFRA:

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

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                                 -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  NOITS 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
         requirements; 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
suspension order under FIFRA 6.  There is, howeve
unlawful act under section 12 for the violation of
3(c)(2)(B) suspension order.  Under section 13 of
Administrator may issue a SSURO when a product is
issuing a SSURO, EPA is able to enforce the suspen
violating a SSURO would be in violation of section
would be subject to the penalties thereunder.  It
each registrant of a suspended product be issued a
for the section 3(c)(2){B) suspension to have the
violati on of a
r , no speci fi c
 a section
FIFRA, the
suspended.  By
sion.  Any person
 12{a)(2)(I) and
is essential that
 SSURO in order
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 nspection.

"ADMINISTRATIVE CONSIDERATIONS

Program Management	

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

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

ALLOCATION OF RESPONSIBILITIES	

OPP
Issues data call-in notices and tracks responses.

Issues NOITS as appropriate and tracks responses.

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

Lifts suspensions when registrant fully complies.

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

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

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

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

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

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                             -5-
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.
                        cases arising from violations of the
Regions will  handle any
SSURO1s issued by OCM.

States
States will conduct follow-up inspections to ensure compliance
with the SSURO's and forward results of the inspections to the
Regions.  For situations involving a violation of the SSURO, the
State will  forward the case file to the Region for appropriate
enforcement action.
PENALTIES
     Violation of a SSURO is a violation under section 12(a)(2)(I)
and subject to the penalties found under section 14(a)(l)  and
section 14(b)(l).  Violation of a SSURO will  generally result in
an administrative civil complaint.  The FIFRA penalty policy
provides guidance on calculating the administrative civil
penalty for this violation.  Repeated or continued violations of
SSURO's will be considered for criminal referral.

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            UNJTED STATES ENVIRONMENTAL PROTECTION AGENCY

                        WASHINGTON, D.C. 2CM60
                                                          OFFICE OF
                                                  PESTICIDES AND TOXIC SUBSTANCl
MEMORANDUM

SUBJECT:  Compliance Monitoring Strategy for Pesticide
          Registration Cancellations Due to Nonpayment of Fees
FROM
TO:
          John J. Neylan III, Director
          Policy and Grants Division
          Office of Compliance Monitoring

          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
                                                            Pnntadon flecvdsJ Paper

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

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      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
                                ADDRESSEES
                              (TS-766C)
                              (TS-767C)
                              (TS-767C)
                              (H-7506C)
                              (LE-134P)
                              (LE-132A)
                              (EN-342)
                                 H

                                 H

                                 It

                                 II

                                 H

                                 It

                                 II

                                 II

                                 H
      Jake Mackenzie
      Western Regional Compliance Director
II
IV
     Marvin Rosenstein, Chief
     Air, Pest. & Toxics Mangt. Div.
     Pest. & Toxic Substances Br.

     Ernest Regna, Chief
     Environmental Services Div.
     Pest. & Toxic Substances Br.
Ill  Larry Miller, Chief
     Hazardous Waste Managt. Div.
     Toxic & Pest. Br.
     Richard D. Stonebraker, Chief
     Air,  Pest. & Toxics Mangt. Di.
     Pest.  & Toxic Substances Br.

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

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

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

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

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.
                      4
 Existing  Stocks

 COMMENT 1

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

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

 RESPONSE  1

 We have incorporated that  statement into the Summary.
COMMENT 2

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

RESPONSE 2

State inspectors should take their direction from the State laws
in those States which have more stringent laws regarding the
distribution and sale of existing stocks of pesticide products no
longer registered by the EPA.
Enforcement Response
COMMENT 3

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

RESPONSE 3

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

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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 S

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

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                                                                        I

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

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

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

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

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

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

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

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

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

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

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beyond those at producing establishments are not needed.  As the
Strategy is amended for future cancellations, Appendix It will be
updated to include Federal Register information on existing
stocks, dates of effective cancellation, etc.


REQUIREMENTS

     The Cancellation Order of October 18, 1989, allowed
registrants to continue to sell and distribute existing stocks of
the cancelled products until March 1, 1990, the due date for the
next annual registration fee.  Existing stocks are defined as
those stocks produced, packaged, and labeled on or before the
effective date of cancellation.  Existing stocks already in the
hands of dealers or users can be sold and used until they are
exhausted.  The exceptions to these provisions are cases where
more stringent restrictions on sale, distribution, or use of the
products have already been imposed through separate Agency
actions.  Dates regarding existing stocks provisions for products
cancelled after subsequent fee periods can be found in
Appendix II.

Exports

     In the case of exports, any products exported after the
effective date of cancellation must comply with section 17 of
FIFRA, which includes citations for other applicable FIFRA
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
say in a conspicuous manner "Hot Registered for Use in the United
States of America").
COMPLIANCE MONITORING	


     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
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 fOCM)	

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 Federa1 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.
     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.  '
Rea.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
ProductName
                           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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                                    APR 30 1990
                                                    .:..= ., - : *.._ SUBST
MEMORANDUM

SUBJECT:  Strategy  for Aldicarb

FROM:     John J. Neylan  III, Director ^f^^t^J//?
          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, 199& 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
f
William H. Sanders III, Director
Environmental Sciences Division, Region V

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

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

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

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

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

 BRANCH CHIEFS:

 Marvin Rosenstein,  Chief
 Pesticides &  Toxic  Substances Branch
 Region I

 Ernest Regna, Chief
 Pesticides &  Toxic  Substances Branch
 Region II

 Larry Miller, Chief
 Toxic & Pesticides  Branch
 Region III

 Richard Stonebraker, Chief
 Pesticides &  Toxic  Substances Branch
 Region IV

 Phyllis Reed, Chief
 Pesticides &  Toxic  Substances Branch
 Region V

 Robert Murphy,  Chief
 Pesticides &  Toxic  Substances Branch
 Region VI

 Leo Alderman, Chief
 Pesticides &  Toxic  Substances Branch
Region VII

Alvin  Yorke,  Chief
 Toxic  Substances Branch
Region VIII

 Davis  Bernstein, Chief
 Pesticides &  Toxic  Substances Branch
Region IX

Kenneth Feigner, Chief
Pesticides &  Toxic  Substances Branch
Region X

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                                                Atracr.r>er.c
         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


264-417

264-331
Temik Brand TSX Granular Aldicarb
  Pesticide (1)

Temik Brand 15G Aldicarb Pesticide (2)

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

                             JOINT SATEMENT BY

                      ENVIRONMENTAL PROTECTION AGENCY

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

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

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

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

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

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                                               (J
To:

From:
         UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                         WASHINGTON. D.C.  20-160

                                           -JAN i Q 1975
           Regip!i2,UL<.lministrators
                ^-.^<. X^-t^L,  4
                    vuinimstrator" lor water
          and Hazardous.Materials (WH-556)

          Assistant Administrator for Enf'orcemeny^'
          and General Counsel (EG-329)

Subject:  Continuing Slate Registration of Products  Containing
          Aldrin and DJeldrin 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 Regions,.  Prelim:.nary
investigation into  the magnitude  of the problem suggests that thore may
bo  significant  continuing activity on a national scale,  that there is con-
fusion as;toT.h-3 extent of Federal jxirisdiction over  such activity by States,
and that the economic,  political  and regulatory considerations  involved
require additional  action by the Agency.

    Accordingly, our joint sUcfs  are preparing a Federal Roister notice,
v.'hich,  upon publication, vail formally assort Fed~3.ral juris diet ion over
nop-Fc:cici'aUy registered products  cor.taining Atclrin and  Dieldrin by
impZoiv.cr/.iug See* Ion  3  of the Federal Insecticide, Fung^eid-? and
l-1ccler.llci-.ie  Ac: (FIFRA), as amended (7 U.S.C.  136 et seo.). Attached
is a strategy pc-p^r \vhich explains the background of this matter in greater
detail and provides an explanation of ho-.v thos-3 Aldrin and Dieldrin pro-
ducts shovdd be  treated upon the activation  of  Section  3.  In add-.tion,
proposed enforcement activities by 
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S'<2     UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
     '
                          WASHINGTON. D.C. 20460
  Strategy Paper:

           State Registration of Products Containing Aldrin and1 Dieldrin
           for Which Uses Have Been Suspended


  Background;

      Late in  December,  1974 Headquarters was informed by Region DC
  and the State  of California that products containing Aldrin and Dieldrin
  were being.registered by the State in possible contravention of  the intent
  of the Administrator's Order of December 7, 1972 (37 F.R, 26463, 26465).
  That order provided that henceforth all technical  Aldrin  and Dieldrin
  must bear the label restriction:  "For use only in formulating 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 provide de facto Federal control of all products containing
  Aldrin or Dieldrin. Investigations by California  and Region IX  (confirmed
  now by several other Regions  and S'tnte.-:) have revealed that many. State-
  rc-isti->;-ed Akii-In-Dieldrin products were:  1) formulated from  tfic.hnical
  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 AldVin-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,
  1072 which failed to bear the required restriction,  4) formulated from
  technical material restrictively labeled and ignored by the formulator.
  States, having lately become aware, of the intent of the December, 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 jurisdic-
  tion over their production,  shipment,  sale, and use, and to insure  uven-
  hancbd enforcement of the Aldrin  and  Dtcldrin cancellation and  suspt->?ion
  orders,  vhc Agency will formally  implement Section 3 of the Federal  Insec-
  ticide, Fungicide, "and Rodculicide Act,  as amctubd {7 U. S. C.  130  et scq.)
  by notice in the Federal Register. This notice will contain an exemption,

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                                         -2-

          nursuant to the provisions of Sections 6{a)(l) and 15(b)(2) of the Act. allow-
          inc States to register for orderly  disposition through shipment, sale and
          use in that State, existing stocks  of products containing Aldrm and
          Dieldrin produced on or before the date of signature by the Administrator
          of the order implementing Section 3 of the Act as to these State-registered
          products. Effective the day following signature of the order implementing
          Section 3 of the Act, production of products containing Aldrm 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
          Stat<^; in that Region, in advance,  of  the planned activation 01 Section 3
          and its attendant prohibitions,  and should request State authorities to _
          noti'v all State registrants and any other potentially affected parties 01
          the uctivalion of Section 3 and of the  effective date  of related prohibitions.
          Stai-s are to be asked to provide  to the appropriate Regional O:nces lists
          of  Sta'-G registrants  or persons with registration applications pending for
          products containing Alcirln or Dieldrin. Information relating  .o .ocaaon
          and relative amounts of these State-registered products also is to be
          sought.

             The -\*encv's pest*c:c!cs enforcement personnel will enlist Slate coope-
          ration in contir.-Jir.? its on-goir.:,- investigation  of  the  formulation since
          Dcc'-ir,b-r 7,  1972^ o: products cor.laimng  Aldrin  or Diclorin fo^ oCR-.e
          rc'rislraioi.   Should it be the case th:.t Federal registrants  o: tecniuca.
          ^1-i^-i o-D^l'-^n u^vc not r^l."bc-lcH their nroducts in coni'ormancc \vitii
          tlie Ad-r'nistr^.or's  Order of December 7, 1072, or  that posticids ?ro-
          duccs  have  fcrmulatec: products eontaiiung Aldrin or Dieldrin in con-
          travention of labeling prohibitions against use in non-Federally registcvcc.
          products, such Eolations vnll bo  prosecuted in accordance with the appro-
          priate pro\asicr.s of tlie Act.
c

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      UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
.<*                     WASHINGTON. D.C.  20460

                                                 . JAN U J23

To:      [Enforcement Division Directors]

From:   A.  E.  Conroyll, Director
         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<;r was to
restrict use  of technical Aldrin and Dieldrin to use in EPA-registered
products only. The Director's  memorandum continued that production
of non-Fedcrally registered products containing Aldrin and Dieidrin
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 Etce^tion that numerous  products containing Aldrin s.nu Dieldrin
r-'3^' have be~n produced since  December 7.  J972 and rpaistproH v,y .Qroi.a*
under circumstances not  svrictly contravening the  December,  1972 Order.
Details concerning this production and questions relating TO the scone of
Federal jurisdiction over such production under  the December, 1972
Ordi"* are  elaborated in the attached memorandum and strategy paper,
which vere sent to all Regional Administrators on January 10, 1975.

Action;

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

         1)  The Agency has determined to  implement Section 3 of the
             Act v/ith 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 Slate
             of stocks  of products containing Aldrin or Dieldrin in  3-ds-
             tence on the  date of the signature by the Administratev of
             the order activating Section 3.  After that date, all tj'-od: c-
             tion of products containing Aldrin or Dieldrin must cease.

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                             and States must cease to permit registration or to allo\v
                             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
                             obtaining for Federal use:

                             -  lists of State registrants or persons with applications
                                pending for Aldrin-Dieldrin product registration;
information on location
ducts within the State;
                                                          relative
such
                             -  assistance of State enforcement authority to achieve com-
                                pliance with the production,  registration,  and shipment,
                                sale and use  cut-off.

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

                     Shovld you have questions or encounter difficulty with rcgaro to any
                 of these matters, please notify  the appropriate Regional Coordinator.
                 Attachments:
c

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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-  FED sends Administrator's order  to Regions

5.  HDQ sends Administrator's order  to States

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

7.  Regions follow-up at each State registrant*

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        o
                                     Attachment II SAMPLE LETTER
State Registrant
(Address)
Gentlemen:

    On (date), the Administrator of the United States Environmental
Protection~"Agcncy 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 et seq.).
As a result of this Order,  the  shipment,  sale,  and use of non-Feder-
ally registered Aldrin-Dieldrin products, produced after the effective
-date-of-t^e-Ord-er-wiH-be-prohib-itedr A-ctx?rdingly7~the-5tatc--af---(Tra.Tni;)
can register or continue registrations only of non-Federally registered
Aldrin-Dieldrin products v/hich were produced on or before the date
of the Order. Such  registrations are being permitted to allow the
orderly disposition of non-Federally registered products through
shipment,  sale, and use in the registering State.

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

                                       Sincerely,

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                                                            Attachment III

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

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

                        Violation:  Misbranded,  inadequate directions
                                   Section !2{a)U)(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)(2MG)
                       Action:     Civil/Criminal/Stop Use

               3.  Sale of a non-Federally registered Aldr-in - Dieldrin product pro-
                  duced after  the efieciive dale of the Order, but before violations
                  are actionable (60 days after publication in the Federal Register).

                       Action:     Sf.op Sal./

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

j                        Violation:  Non registration Sec.  12(a)U)(A)
I                       Action:     Civil/Criminal/Stop Sale

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            UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                        WASHINGTON. DC 20460
                         JUN   6 1989
  OFFCEC*

 PESTCJDeS *ND

TOXIC SUBSTANCES
MEMORANDUM

SUBJECT:  Compliance  Strategy  for  the  Cancellation
          Uses  of  the Inorganic  Arsenlcal's

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

TO:       Addressees

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

     The turf herbicidal  use of the flowable  formulation of
calcium arsenate,  the grapefruit growth regulator use  of lead
arsenate, the grape fungicidal use of  sodium  arsentte, 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 f3(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
wilt  be conducted to  ensure that cancelled products are  no
longer being sold or  used.  Tips and complaints are to be
investigated as received.

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                           -2-
     The cancellation has been appealed and a list of  those
persons appealing the cancellation is attached.   If you have
any questions concerning this action please contact David
Stangel of my staff at 382-3477.
Attachments

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                                 ADDRESSEES
     Doug I as D. Campt
     Edwin F. TJnsworth
     Anne Lindsay
     Frederick F. Stiehl
     Mark Greenwood
     A. E. Conroy 11
     Connie Musgrove
     John J. Neylan Ml
     David Dull
     Mike Wood
     PhylI is Flaherty
     Jerry Stgbbs
     Maureen Lydon
     Ken Kanagalingam
     Bob Zisa
     Sherry SterlIng
     Jake Mackenzie
     Western Regional Compliance Director
(TS-766C)

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

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

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

     All minor uses of Inorganic arsenicals with the exception
of the  Insecticide use of arsenic trioxlde 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,
1968.  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	

     AM registrants, producers, distributors, and users of the
minor use products of Inorganic arsenicals with the exception
of arsenic trioxlde 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-
Exfstlng 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.  Thfs
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 (n accordance with the applicable
requirements of the Resource Conservation and Recovery Act
(RCRA).  NoncompI lance with the cancellation order Is a
violation of FIFRA 12(a)(1)(A) and 12Ca)(2)(K).
COMPLIANCE MONITORING	

     Compliance with the NOIC will be determined by Inspection
of registrants and producers of cancelled products to determine
if production and sale for distribution within the U.S. has
ceased and that distributors have been notified of the action
as required by the Notice.  These Inspections are to be carried
out within 6 months of receipt of this compliance strategy.
During routine inspections of dealers and users, inspectors
should ensure that cancelled products are no longer being sold
or used.  Tips and complaints are to be Investigated as
rece!ved .

Neutral Administrative Inspection Scheme

     Since the issuance of the Cancellation Order Is an
administrative action which cancels all minor non-wood
preservative uses of the inorganic arsenicals with the
exception of the two previously mentioned uses of arsenic
trioxide, Inspections for violations of this cancellation order
will take piece 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	

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

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                             -3-
WIM transmit the list of those products which have been
cancelled to the Regions.

Will transmit the list of registrants and producing
establishments of Inorganic arsenicals to the Regions.

Reg ions	

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

Will distribute a list of products, registrants and producing
establishments affected by this Notice to the States.

Will conduct inspections In States without Cooperative
Enforcement Agreements as part of their routine Inspectional
schedule.

Will take enforcement actions as appropriate.

States	

Will conduct Inspections of registrants within 6 months of
receipt of the compliance strategy.

Will conduct inspections of dealers as part of their routine
inspectional schedule.

Will take enforcement actions as appropriate.

Will report to the Regions on actions taken under this Notice,

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     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
  t 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
                           JU.  6
                                                 reiTiciois ANO TOXIC SU>STA
MEMORANDUM

SUBJECT:  Compliance  Strategy  for  the  Conditional  Registration
          and- Cancellation  of  CertaitfNlrom

FROM:     John J.  Neylan  III,  Director
          Policy  and  Grants  Division
          Office .of Compl iance Monitori

TO:       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
VI
VI
      Douglas 0.  Campt
      Edwin F. Tlnsworth
      Anne Lindsay
      Frederick F. Stlehl
      Mark Greenwood
      A.  E. Conroy I I
      Connie Musgrove
      Mike Wood
      Jerry Stubbs
      Sherry SterI ing
      Davi d Duli
      Ken Kanagal ingam
      Bob Zisa
      John J. 'Neylan  I I I
      Phyl Ms E.  Flaherty
      Maureen Lydon
                     (H7501C)
                     (H7505C)
                     CH7505C)
                     CLE-134A)
                     (LE-132A)
                     (EN-342)
                        tt
                        tt
                        it
                        tt
                        tt
                        tt
                        tt
                        n
                        tt
                        tt
      Jake Mackenzie
      Western Regional  Compliance  Director
IX
Loufs F. GItto, Director
Air Management Division

Barbara Metzger, Director 
Environmental Services Division

Stephen R. Wassersug, Director
Hazardous Waste Management DFv

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

William H. Sanders  III, Director
Environmental Services Division

W!iIiam 3. Hathaway, Director
Air,  Pesticides 4 Toxic Division

William  A. Spratlln, Director
Air and Toxics Division

Irwfn L. DIcksteIn, Director
Air and Toxics Division

David P. Howekamp, Director
Aic Management Division

Gary 0'NeaI, D i rector
Air and Toxics Division  '
Marvin Rosensteln, Chief
Pesticides 4 Toxic Substances Br

Ernest Regna, Chief
Pesticides 4 Toxic Substances Br

Larry Miller, 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

Carj 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 Roefoffs        (TS-788)
     John Tlce           (TS-769C)
     Al Hefer            (A-107)

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    8ROMOXYNIL  CONDITIONAL REGISTRATION AMD  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*
Restickering of products released for shipment
after 5/5/89; Stickers sent to dealers for
relabeling by 5/15/89.
Restickering of dealer stocks carried out by
Registf
Produce
Oistrifc
by 9/6/89*
between 10/1/89
and 11/1/89
between 10/1/89
and Spring,  1990
growing season
          5/25/89; Ppint-of-purchase communication carried
          out by registrant per schedule in conditions of
          registration.

          Used only by certified applicators according to        User
          conditions of registration.

          Revised Labelling on all products by 10/1/89; all     -Registr.
          bulk containers have correct transfer mechanism by     Produce
          10/1/89.

          Compliance with EPA-approved user training plan.       Registry
          Plan must be implemented prior to 1990  Spring          User
          growing season.                                   "   Interfac
  2.
Voluntary  Cancellation of  Broiiroxym'l. Butyrate  Products**

                                                               LEVEL
TARGET DATE FOR
INSPECTION
ACTIVITY TO BE MONITORED BY INSPECTION,
PER TARGET DATE
by 8/7/89


by 9/6/89*

by 9/6/89*
          No shipments intended for sale/use after 6/12/89


          No sale after 6/12/89

          No use after 6/12/89
                                                    Registrar
                                                    Producer

                                                    Distribul

                                                    User
*    As part of routine inspections.

**   Includes  the following products:  Dragonmate, ME 4 Brorainal, Torch Twin Pak, 3+3
     Brominal, Broraoxynil Butyrate Technical, Certrol, and Buctril 4 EC.

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            COMPLIANCE STRATEGY FOR THE CONDITIONAL  REGISTRATION
              AND CANCELLATION OF CERTAIN BROMOXYNIL PRODUCTS
OVERVIEW	:	

     Bromoxynil is 'a  selective, post emergence 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,ienc to conditionally amend the registrations of three
bromoxynil pesticide  products (buctril, bronate, and buctril +
atrazine), pursuant to FIFRA section 3(c)(7)(A).

     On June 5, 1989  the Director of the Office of Pesticide
Programs, Office of Pesticides and Toxic Substances, signed a
FEDERAL REGISTER Notice entitled: "Order Cancelling Registrations
For Pesticide Products Containing Bromoxynil Butyrate."  The
registrant requested  voluntarily cancellation of bromoxynil
butyrate products and proposed to condu'ct a recall of the
cancelled products down to the user level.
REGULATED COMMUNITY	

     Rhone-Poulenc, the only registrant, producers,
distributors, and users of bromoxynil are affected by the
Agreement and the Cancellation Order, although responsibility
for meeting the terms of the conditional registration Agreement
is on the registrant.  At the time of the Agreement and
Cancellation Order there were 8 registrations and 6 producer
establishments.  A list of these can be found in the Appendix.
REQUIREMENTS 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

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                                     -2-

 the Agency to better estimate the magnitude  of  risk  to  exposed
 workers.

 Stocks of Products With Amended Stickerina/Lahelinq	

      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.
            i
      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 l,  1990, the registrant is required to have
 investigated and  reported to EPA, the feasibility of packaging
 bromoxynil produces  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 MOMITQRING
Regional /State Activities
     Inspections wili.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 taken, as appropriate, by the States
and Regions, with reports of such actions and/or potential
violations made to EPA headquarters.  States and Regions will
also report to EPA headquarters all violations or potential

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                                    -4-      -          ' '

and Regions, with reports of such actions and/or potential
violations made to EPA headquarters.  States and Regions win
also report to EPA headquarters all violations or potential
violations of the conditions of registration of bromoxynii
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 bromoxynii products within the U.S. has ceased.
Information obtained during inspections of registrants records
regarding disposition of stocks of conditionally registered and
cancelled products should be forwarded to other Regions for
their use in scheduling inspections.

     After October 1, 1989 inspections at producer
establishments will assure that all products released for
shipment by the registrant have the required revised labelling,
and that all bulk containers released for shipment include the
required mechanical transfer mechanism with a drip-free hard
coupling.

     After October 1, 1989, and before the Spring 1990 planting
season, inspections will be conducted to determine registrant
compliance with the EPA-apprbved plan for user training and
assistance.  This plan will be sent to the States and Regions
following its approval.  The inspections will be appropriately
directed at the registrant-user interface and may, for example,
include monitoring or inspection of training sessions/materials
by Regions or States.

     Within 60 days of the date of this strategy, the
Regions/States will follow-up and track the recall of the
cancelled bromoxynii butyrate products, that the registrant is
undertaking, following the outlines in section 14 of the
Pesticides Inspection Manual.

pis, tr ibutpryftqsel J.er /Ret;a j. 1 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 bromoxynii
butyrate products within the U.S. has ceased.

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                                    -5-
User Level
     Within 60 days of the date of this strategy, inspectors
will assure, during routine scheduled inspections, that non-
cancelled bromoxyni.l products are being used only by certified
applicators and in accordance with the use directions and
protective clothing requirements on the amended sticker/label,
and that cancelled bromoxynil butyrate products are not being
used.
ALLOCATION OF RESPONSIBILITIES	

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.

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                                    -6-
 noncompliance with  the  requirements of the Agreement, includingI
 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 win 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.

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                                            APPENDIX

                 BROMOXYNIL REGISTRANT, PRODUCTS, AND PRODUCING ESTABLISHMENTS (1985-87)
Rhone-Poulenc AG Company
P.O. Box 12)14 2 T.W. Alexander Drive
Research Triangle Park, NC 27709
Product Name

Buctril*
EPA Reg. No.

  264-437
Broot 15GX (Bronate)*    264-438
  ii    H
Buctril + Atrazine*

ME 4 Brominal
{Buctril ME 4)**
(Also produced as
3+3 Brcminal
and Torch Twin Pack)
  264-477


  264-340
  Estab. No.

  264-OR-001



  264-OR-001

  264-IA-001
Estab. Address

Rhone-Poulenc AG Company
6200 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      Rhone-Poulenc AG Company
                  T.W.  Alexander Dr
                  Research Triangle Pk,  NC   27709

55259-IL-001      Bradford Ag Service Inc.
                  401 Phoenix Ave
                  Bradford, IL  61421

 2393-IL-003      Hopkins Agri. Chemical  Co.
                  303 SW Arch St.
                  Atlanta, IL  61723

  No USA Production Records for 1985-88

  264-MO-001      Rhone-Poulenc AG Company
                  PO Box 367
                  317 West Florence Road
                  St. Joseph, MO  64502

 2393-IL-003      Hopkins Agricultural Chemical  Co
                  303 SW Arch St.
                  Atlanta, IL  61723

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                                              -2-
Dragomate Broadleaf
 Herbicide**
264*339
264-MO-001
Rhone-Poulenc
PO Box 367
317 West Florence Rd
St. Joseph, MO  64502
  uoncntionany 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.  54.  No.  Ill /  Monday. |une 12. 1989 / Notices
                                                                                                                      24*49
    name ol applicant
                            locauon
tans M"W lighting Co. '	' we* taBytan. NY ....; Conduction of a 220 MW a** utra generation | NVSC6C	j PSD pun*
NMMU Catnet Energy Coo .., unondlM. NY
Kamne Carthage Cogenera-  ' Carthage, NY
  wjn Co . Inc.
                                               .
                                        ConnjctJon *  57 MW cogenennon faoMy	' NYSCEC		
                                       ! Conwucaon ol  50 MW jaa tunna. siMrn gener-
                                       !   itor.
Momli P'esi Co	i Fultan, NY		 Construction of an 11 ttanon rotaqravm
                                                                                                  _....do	
                                                                                                  	do	-	-.-
                                                                                 NYSDEC ...............  I   HO
       Sou* Glens e jus  Satin Stens Film.
              .. :nc       NY
           energy v- : TsnawerWa. !fY- ...
  CM. Inc.
SOIM Ciicad* Con? ............ 3r. Fi.-f. NY
        (j ccf. tnc	 3tv3env MJ
                                          "
                                         o'
                                          aior
                                                  of  50 NW gee wem,tiM>n flener- i NYSCEC ------------ _
                                                     a 53 MW ]*1 furDine.'Steam gener-  NYSDEC ................... | ..... Ml
                                                                                                 |
                                               -wtnt ot en aaang a^fircd  txM*r witn   NYSMC ...... -------- ..... | PSO no*
                                          vision of tne nitrogen oude emisaon lirml pawn-  Xf* region II....
                                               permmed  tor a 23.3  MW  eogenenucn   \
        Inc .............    . . . ;

     island Ughnng Co .........
                           '.. NJ	_..

                                NY	
        of int
          r permuted tor
Aooon
  inc.
United CMiO6oer 5. 1988 Pc~s_, o.-..sf_jn notice on f*n PSD tci"!"! oecauw JvVusffloBy!fln ;'ant n ciruiderte trecave aa of uiv T. 1988.                            	
    s T-:e Panrsauiiai SK'.v  YJI*. New York
NYSDEC Actions
New York Sla! Dop-jr^ieat of
   En-, :ronmciitnl Ccrser\a?ion. Division
   Of Air Resources, sourc\Rev:ew and
   Re-.vunal Support SfcttonVSO V.'oif
 . Road. Albany. New York. r^:33-0'jm.

N|DEP Actions
.'-'ew J-rsey IV f^r'ment of
   Er.'ronrr.i n!ai Protection. D,\ .aiNn of
   ^n\iranmer.i.: A Technoii cv 401 E"5t>
                                           jtate Street. Trenlon. New Jersey
                                             B25.
                                               L avail able pursuant to the
                                           Consolidated Permit Regulations (40
                                           CFR Part 124). jndicial review of these
                                                       urs under sectian 307(b)(lJ
                                           of the Clewi Air Act .the Act) 3iay be
                                           s^vaht or.ljKby the fiiiri! of a peti'ion for
                                           review ;n th^i'ni.'ed States Court cf
                                           Appeals for tM. appropriate circuit
                                           within 80 days hem the date on which
                                           these de'erminahtas are published in
                                           the Federal Register. Under sect'on
                                           307(b](2}of.heAct.f.c?e
                                           determinations shall iw be sui.pct to
                                           Liter judicial review ir. cii"l or or
                                           prcceedingj for

                                             Dated: June l. IS&J.

                                           WilUam). M
                                                                                      IOPP-4C1M; FRL-3600-4]
                                                                                      Ontor CancUng Registration for
                                                                                      Pmttaet*) Products Containing
                                                                                      Bromoxynil Butyratt*
                                                                                      AGEKCY: Environmental Protection
                                                                                      Agency [EPA).
                                                                                             : Cancellation notice and order.
                                            ;:n Doc. !')-l.ia;9 Filed fr-9-flfl 8  .in]

                                            BILLIKC CCCC 5SCO-SO-tl
                                                                                      CUWMASY: This noace announces EPA '
                                                                                      decision to cancel all registrations
                                                                                      i'-sued under the Federal Insecticide.
                                                                                      I'ur.gicide. and Rodenticide Act (F1FRA)
                                                                                      fur pesticide products containing the
                                                                                      L ut\ Tic acid esMr of bromonynil (13-
                                                                                      (Jibrorro-4-hydroxybenzonitri!e|. The
                                                                                      r.'gtsirint Rhone-Poulenc AC Compnny
                                                                                      has requested voluntary cancellation of
                                                                                      these products. Because cf the
                                                                                      u-:velcpr?.ental risks asior.tate J wiih
                                                                                      c.vposure to these product*. EPA will nut
                                                                                      permit and  the cnncellauon order will
                                                                                      explicitly prohibit the sale, distribution.
                                                                                      
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241^0
Fedurjl  Register
                     Mor.t;,iv.
DATE: The cancellation order
incorporated in this notice will become
effective fune 13.1989.
FOB FURTHER INFORMATION CONTACT:
fuJi; Andreasen. Special Re\. lew/
  Rr-egistration Division (H7j08C),
  Ofhce of Pesticide Programs.
  r-'..v. :mr.TTicntal Protection Agency. -4U1
  M Sir-ret SW.. Washington. DC 20400
Office location and telephone number
  F,-;.  lOOhF CM =:. 10:1 Jfrffprscm
  n.)v:s Highway,  Arlington. VA. (70"!
  jj'-nro."
SUPPLEMENTARY INFORMATION:

I. Request for Voluntary Cancellation
  On Mjy l'. 1989.  ^s a result of
discussion between EPA and Rhone-
Pc.:::-nc AC Company concerning
measures to minimize potential risk of
developmental toxicity associated  w.th
exposure to hromoxynil. Rhone-Pouienc
requested voluntary cancellation of its
registered pesticide products containing
bromoxynil butyrale (the butyric acid
ester of 3.5-dibromo-4-
hydroxybenzanitrile). 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
Ihsse 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 sen-ice. Users
holij.ng 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
i's products containing bromoxynil
butyrate. on October 27,1968. EPA
canceled certain bromoxynil products
pursuant to this request, but wa
unwilling to accept the remaining
requests for voluntary cancellation
because those request* were made
contingent on the Agency's permission
to sell and use existing stocks of
affected product*.  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
                   bt;tyr;ite Aouid present art una
                   nsk of development;*! toxicity :n
                   handling sur.h products. Accordingly.
                   EPA will not perm:! the continued s.ilc.-,
                   distribution  or ine of jr,y canrcltfJ
                   product contains h'orruxyr;;! hutyr'i'-v
                   EPA encour.i^t-s aiJ pers..'-s holdi-g
                   Mocks o[c.-t~jdt,>d produces cont.iu'.jns
                   bromoxynii bu'\rd!e to p.-i;p:ic'.pj!e in the
                   rcrovrry prog-am established b>  Rhone-
                   Po-jlenc.

                   111. Cancellation Order

                     Efiectivs June 1.1. !9fi9. tlie
                   registrations for j!l pesticide products
                   containing thfi t'jtyr-c aci j e;-ter of
                   bromoxynii (3.5-Jib-omo-4-
                   KyJroxybenzonitrilt) are canceled
                   pursuant to section 6ff)(l) of FIFRA, r
                   U.S.C. 136d(f)[l). Effective June 13. 1989.
                   it shall be  unlawful under FIFRA  section
                   :2f;i)(D(A) and/or FIFRA section
                   12faj(2)fK). 7 U.S.C. 136j(a)(l)(A).
                   136j(a|(2)(K). for any person to distribute
                   or sell, or to use for any pesticidal
                   purpose, any of the following canceled
                   products containing the butyric acid
                   ester of bromoxynil:
  EPA    I
registration i registration
  No.    ;    NO.
                                             Product
                      284-339 :
                      264-3 !	 M6 4 BrcmiinJ.
                      264-340 '	 Torch Twin Pak
                      264-340 	j 3*3 Sronnrw
                      264-3S4 I	 Sromovn* 9oyie
                                       '
                      264474
                                        Ctnroi
                                        Sustn(4C.
                     This Order docs not prohibit any
                   shipments of canceled products
                   containing the butyric acid ester of
                   bromoxynil which are associated with
                   the program to recover stocks of such
                   products established by Rhone-Poulenc
                   AC Company, or which are otherwise
                   necessary to facilitate proper storage or
                   disposal of such products.
                     Dated: June 5.1989.
                   Douglas 0. Caaipt,
                   Director, Office of Pesticide Fragrant.
                   [FR Doc. 89-13Wfl Filed 6--89:8:45 am)
                       gRAL MARITIME COMMISSION

                             :  F. ,.

                                       205TX vviihir, 10 days 
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     T4      UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                        WASHINGTON. D.C. 20460

                                                          ornei or
   - -                                           "  ^esTicioes AND TOXIC zucsr/

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 will be contingent on satisfaction of each of the
conditions set forth in the approved amendment.  Please submit
for each of the subject registrations five  (5)  copies of the
final printed stickers incorporating this amendment.  A stamper
copy of the approved text for these  stickers  is enclosed for your
records.
                                  Sincerely  yours,
                                         *:  Taylor
                                  Product Manager  <25)
                                  Fungicide-Herbicide  Branch
                                  Registration Division (H7505C1

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                                             (INCLUDING COVER PACE).
  FAX NO
  ATmS.FACS'WLE " PHON IF "*  T U..KE  AU PAGS
  FACSIMILE NO,
 DIRECT LINE TO TELECOMMUNICATIONS OPERATOR ISi 919-509-2395


                                      UPre*
                                     MESSAGg
     TO;  Edwfn  Tinsworth
         EPA
  ,.. Attached  1s the Apjjjjcation for Amended Registration of bromoxynil  products.
  3 'It should contain all the revisions discussed.  A copy is also being sent ove
    mafl.   If there are any questions, please let me know
overnight
    Sincerely,

    Nick  Sonrna
'513A

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RHpNE-POULENC
KHdNE-POULCNC AO COMPANY

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

          Rh6ne-Pouienc  Ag  Compony  hereby applies  to  conditionally
    amend  pursuant  to FIFRA $3 (c) (7)  (a)  the pesticide product
    referenced above to  incorporate the revised labeling, new
    classification  for restricted  use,  additional claims, and  specific
    conditions for continued registration  set forth  below.  Rh6ne  Poulcnc
    hereby  claims in connection  with  this application  for u-nencc..
    registration  that  it will.conform  to the following conditions as  oart 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  uie  practices
    is appended to  this Application  as  Attachment A..  Rhone Poulcnc
    agrees as a condition of registration that  it will 'attach the stickers
    appended to this Application  as  Attachment A  to- all containers of
    these products  that are  released for shipment  by  Rhonc-Poulenc
    after  the  date of approval of this amendment by EPA.    Rhdne
    Poulenc  further agrees as a condition of registration that it will
                      ANWCW*CK U*C RTP

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                     CONDITIONAL  REGISTRATION
  Revised Labeling
     A. Wh a t
          1.Classification
          2.Warning Label
          3.New use pracices
     B.How
          1.Stickers
               a.All stocks leaving
               b.All stocks leaving
                    (1)instruetions
                    '(2)enough for all
          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
                    (2)all restickering provisions
                    (3)equipment needs
       RP after 5/5/89
       distributors after 5/15/89

         inventory by 5/25/89
                      non-crop uses
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.Repackaging
     A.Hard-coupling for all
     B.Feasibility study for
bulk (>30 ga! ) by 10/1/89
small containers by 1/1/90
IV.Safety assessment data
     A.Rabbit dermal Tox--5/l/90
     B.Male repro 6/1/90
     C.Worker exposure--12/31/90

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ilk
    RHONE-POULENC
   RHONE-POUUENC AQ COMPANY
        provide  to each  distributor  holding inventory of  these  products
        quantities  of these slickers  sufficient  for  such inventory  within  ten
        days  after the date of approval  of  this amendment by EPA,  and that
        Rh6ne Poulenc will assume responsibility for insuring  that  each
        distributor attaches the sticker to each  container  of these products
        which are sold or distributed  by the  distributor after the date the
        stickers  are  received.  Rhdne  Poulenc  further agrees  as  a  condition of
        registration that  it  will provide  to  each reseller and retailer holding
        inventory  of these products quantities of  this sticker sufficient for
        such  inventory  within  twenty  days  after  the  date  of approval  of  this
        amendment by EPA, and that  Rhdne Poulenc  will assume
        responsibility for  insuring  that each  such reseller or retailer attaches
        the sucker to  each container which  is sold or distributed  by the
        reseller or retailer  after  the date the stickers are  received.   Rhdne
        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 P. . Rhone-Poulenc -agrees as a condition of registration
        that, after  review  and  approval by  EPA of the complete revised
        labeling  to be submitted by  May 22,  1989, such  revised labeling  will
        be Attached  to each container  of these products which  are  released
        for shipment  by  Rhone-Poulenc  after  October 1,  1989.

              Rhdne  Poulenc further agrees  as a condition of registration  that
        it  will develop and submit to EPA by  October 1, 1989 a proposed
   PO COX I  2 TW  F KAN.Y II ONifE
         Tticx suMiftx 49993?*.
(NTf ftNtf.ONAt. D<9TM
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if RHONE-POULENC
    r ^^'^I'^^g^"

     MH6NI POUU6NC AO COMPANY
         program to provide  additional training  to  users  of bromoxynil
         products prior to the* 1990 spring  use season, and  will upon approval
         by  EPA implement  such  a training program.  Rhone-Poulcnc  further
         agrees as a condition of registration that 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  mining
         and loading system,  and will  provide  to EPA a detailed report of iis
         findings  and conclusions no  later than January I,  1990.  For products
         sold in bulk  containers:  Rhone-Poulenc hereby  applies to amend  its
         registration  for  these products lo provide,  and agrees as  a condition
         of registration,  (hat  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  compatible  coupling.

               For each  of the  specific data  requirements described below,
         Rhdne Poulenc  agrees as  a condition  of registration (hat it wilt
         develop  and submit  the specified data  according to the specified
         schedule.  Rhdne  Poulenc agrees that failure to submit the  required
         data, or  to  adhere to any  element of the  specified  schedule  for
         development and submission  of  the  data,  will constitute  grounds  for
         cancellation of Uiis registration under F1FRA  $ 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 10  Uie  specified  schedule and that  its  failure  to submit  the
         data or to adhere  to the schedule was due  to  factors  that  could  not
         reasonably  have been within its control.
         Rabbit  Dermal  Teratology Study
     O 99* WM. >  w U *< PO've
     fSIAKHIAlANw.kMtlM HC 1\ft
            . .
    mTCftMTiONA.. D'STfl SU7.C* SEftVCCS TUCK N'JWOCn *W83"-*MCWCnaC ACT iQS

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      (ff RHQNE-POULENC
           WHdNf-POULENC AQ COMPANY

                Pilot:
                Full:
                     Submit Protocol--May 8, 1989
                     EPA Approval of Protocol by--May 23, 1989
                     Study InitiationMay 31. 1989
                     Study Completed-Septembcr  I,  1989
                     Final  Report-October 16, 1989
                     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:
               Full:
                     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
                     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  1.  1990
               Worker Exposure  Study

               Submit Protocol-June 15, 1989
           SA*OT.ANGlWAK
_

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tf  RHQNE-POULENC
    RH6NE-POULINC 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, Rhone-Poulenc  agrees
         that  it will  adhere to ihe 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 .lion ft.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
                                                Cioc

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  RH&NE-POULENC
 RH6N6-POULENC Ad COMPANY

      assessment  of the  risks  and benefits of use  of bromoxynil and which
      was not available to either EPA or Rhone-Poulenc 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 Tins worth
"O iOX 19014 9 TW *vCxM06B MVE
              NC
                                            OS

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j&EPA

264-477
i Nm and AOO'tM Of *tf pl-ci
QMicNt $f "v*t>ei4* ^fOflff^i n"9 ^8^1
Vt%4/\lngto, 00 JSCM4KS
Application for Pwtlcida: P Registration
(JsAmcndment
102852
- --. _ , SacHon
13. Di ftaft ) FrMwet Mvigtr "^
j May 1. 1989 Robert Taylor
4 PropOUC Cltt ' ;^
f\i(inekA*Vt 355*7 " ' 	 ' " 	 "  ' 	
Rhont -Poultnc Ag Company
P. 0. Box 12014, 2 T. W. Alexander Drive
Research Triangle Park, NC 27709
       Nam*
               Buctrll * Atrazlne Herbicide
                                                                              0tt of Utter

                                                                                    1.  1989
          Label  modification to Include  Restricted  Use Classification and additional
          laoel  restrictions.
                                             Bectton HI
m TH**
                  n 9* Pe
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-------

-------
Offic* o< *ti>c>dt PfoQ'*m
^^ ^HV M^fc ^B WMftinglen. DC 80*
Vy ERrX Application for Pesticide:

264-438

2 Oil* 3 A
May 1, 1989
irS-f^l")
I] Registration 10285i
JL1 Amendment

08eiMnfr  >ro'pO8 tM C.
Robert Taylor /"let-** fP-^
S *am n4'"'Ad0'tM e( Applicant (Wio* Z* COtf; " ' ' 	 "* '
Rhone* Poulenc Ag Company
P. 0. Box UOJ4. 2 T. W. Alexander Drive
Research Triangle Park, NC 27709
Bronate Herbicide
i  Swb^Mf
ofi
       iuMMM ui *;, tofttr
                                     lnt<>
                                                                        0i of un'

                                                                         May 1.
            LaOel modification to  Include Restricted Use Classification and  additional
            label restrictions.
                                               etlgn III
   Mtni
  ^i*a Hini PMfcaQin0
      W  QND
                              in
   L0*Uon p N> ContffnM M/(iaiion
                                                       MMke* MtOM   M. *r MMUiAM
                                                                          Tnwcf
                                                                         ~n*ui
                                                                                      Olhm ffpwiy;
                                         . Mtnntr M Which UM'  A..0 To Product
                                               ft*eilfln IV
 N4?
              aa^i^ii^ tr~*.m~ m, ^^e,,, /, ^.a.yfr.qj

       Nick  Somma
       Registration Manager
                                               9W-549-2372
  ' artwio'wodp* tfwt M^y
inwnl w ootri undf WDNM
                             riMd* on Ate fenn nd 0 i
                                                                       by CM 0r
 rTyp^rttW
             Nick
ssTSnpMrcHnfsswTsnr^'iSHi* *  oo*w*i*"
                                                        Registration Manager
                                                Hay 1.  1989

-------

-------
                                     $1*1*1
                                                Propr
                                                . OC
                                                    axoo
                        Application for Feticide:     Registration
                          KK                         H Amendment
                                                                             QOO
                                                                                 102850
              NumMr
        264-437
                          I OM*
                           Hay  1.  1989
Robert Taylor
                        4 Propo**a
                                       *'''C'
n~     fvT**!'
Q>n-< [X |,,a
                              Rhone~Poulenc Ag  Company
                              P.  0.  Box 12014,  2 T.  W. Alexander Drive
                              Research Triangle Park, NC  27709
I"] CM* w mit n  nw *0dru
                    .
             Buctrll  Herbicide
 Swojaot
                                 Saeilan II . Amandmant Information
                              anal printed label
                               ftiPPfiil B net
                                    lMtqjg>lW*ttl>r_
                        Data pf uafltr
                        **y  i-  i9S9
        Label modi ff cation to  Include Restricted  Use Classification and additional
        label restrictions.                          '  -
                                           tCt<00L
 Maiaftai THIJ Pfoflxa vwi fa Pacxaaao
Location ef Ubai Otraationa
                                      ND. pw
                                                    1  IYM  !""|NB
                                                    Paekaea wlgM   No. p
                            (*t P  vUl  ontainir
                                                                                  Haaue
                                                                                  OIM*
                                                                                 Othai
3

                                     ii
                                            *
 i OantaatPoini 
-------

-------
ATTACHMENT A

-------

-------
                             IICTED USE PESTICIDE
    for ratal *** ts and u only by Gfl*tad Appfaflora ot pTons diwsty urvhx ttwi M^nmon and only tor *ca UMS QDVWWJ by
 BUCTRIL* HERBICIDE
 WH IHk UUMWd Bf CEflAlN tfHCADLEAF WEEDS IN SMALL OIUJMS. SEEOUHq ALFALFA. OOPH SORCHUM. PLAX. SAHUC
 ONK5KAWUSSANO>iNT. -	'   	
 ACTIVE IMCftED4EWT.                                                 "                  "
                                                                          .33.4%
 Qremexynll eetna*te qwbclwfl to (24% e( bremorynll or not tow Ihwt
                    KEEP OUT OF REACH OF CHILDREN
                           AVISO   WARNING
                                 . no um * proaucto t>6 qu
NAJAHOf TO MUHAW *NO DOU(T10 AM
              UM
<
                                             OCNUtat MOtHMMturi torn au UN
                                                           * !>< *l ! < r
                                              M> tftt^f  IMP in MW. Q* Ml M* r i*->M
             Mf VMll>IVMva
             n0oywnc AflConMT

Mtei MAMM.IM tx oonc(im*Ti MUSI atttvt n FOUOWMQ
Ww <* W !' WM| OTrttttl U OMV  MX!
MlM! Til, CBW* l*l t 
                                           trATtHTMt Of MA6HOAI tniATUIMT
                                           NF tOAllOWfOi Ow mmrnttl Mvww 0* * iMn** nwniMf WMftfii o
                                           -    o(	
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                                             0 IK ITU; PUait HWI v^v 
                                                              M 0*  *W xk  *' 3 " B*t **"
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                                                        > 
MTAU.N* M
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-------

-------
   For rUI Mb to vd
               "RESTRICTED USE PESTICIDE
BUCTRIL** Atrazine Herbicide	
*6stlMEflGENT HERSICIOE FOR CONTROL OF CERTAIN BROAOLEAF WEEDS IN CORN AND
SOBGMUM.      	
ACTIVE INQflEDOJT
  Oetirtolo *oM **r of bromonynl
 gtien.
 "Pwdus certain* ZO poem* of
                   KEEP OUT OP REACH OF CHILDREN
                                  CAUTION
                             SHAKE WELL BEFORE USING	
EPA Hifl. NO. Z>477
                    Pbc BMCRGCNCY totomvtten ONLY QiH 24 Hwr A toy t^OCK4.7577
          T*TfMMT

      TO MVMAN* *
VMMMMO . HfSTMCTtO UM
Uw < M( vWvW M*r
MM * (hem l * tf *< I"
       ( *li*M to MrtUwlvif wife* *
          Ul MMML
                                            OUMWO
                                                       .*ci
                                                      red *u UM
                                                                          < f
                                                             0*   
                                            *>  r> fxm 
                                             IWAILOMO: 0*
                                                 0 "
                                                                Oe net

                             tor
**
                              I 9 
   mm <
44.1. cK>M vnvMQ n< wwouer on acfti*MO on cuMa ceumeNT
MR WlTM TM MtOOUCT. *JUT OttCMVf TUf *OLbOM*O NCQUM(MCMTf
                                         IMl PMEM*  MM U MIM M HI* UW  >> ^^
                                                                            OMn>i( ol
                                                                          IN i MAW**
                                         n w A wwn or
                                         MCOMIT|MT WITH IT*
                                                          u TO UK TIM
              ) WM I*
 up* tan  m*ir *  wn^KWIr WMM*     	
  (Ml **t*f  * O 1M W MM*  ta  *T. T 

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   mm***     '*"*   "^*  '
                                    ' mum 
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                 I I^M ^>^M MM^pMNrf ftl4 mk-MwOT IW* ^W* M^>MwM
                                         TOMjM

                                         0MJM*VlMlMr**M* *  lTmul (MM V ' POt

                                          HfMl. Hra  WWCIMB OPW '* f  MM>*
                                            mcnavt
                                                     M  0 Ml *  W *<* > . i CpflNV !
                                            COMTAMM
O Iti4.f T Mr iMii>Olii*

-------
            T> e
                                                          i T ~ r sc arrr.
                  RESTRICTED  USE PESTICIDE
    For rul MM to and u*t only By Ord Af*oo or p.-*am dcfly vrnr ih lpVrvon and only  ptaOmJ B aUr'd R*4'UJ \Jyu
 BRONATE* Herbicide
 FOR CONTROL OF CERTAIN B"U*UUe.Ar
 ACTIVE INGREDIENT
                           (3,
INERT NORICXINTS;
          no
          V9% 2i
                                                                                  34.0*.

                                                                                  1M.V*.
                                  d orngi i>a mar 2 0 ppndi MCPA aod pt
                     KEEP OUT OF REACH OF CHILDREN
                                     WARNING
                                                                       EPA tit. No.
                             POT PRODUCT USE Information CAN 1*OO-3S4-9745
                      gor IMgftCEHCY information fitlUC C*" 2* Hour< A P>y i <0v *nMwl.  WVMMI <
NIA**>H( *f ***** 

                                                                        3PP tt 0 **!. (rw> < 9  <.
                 *"WW^* BWW ft P^ftJH  ^BP ft^MAV )

                           MMB iM>ir* **t*+*tl tnflf*   ATTf  OML >ili ' * !><< *l tH. .*< *<

                                >'           aiMax M^BB^I iT.M, 7!7i'ia> M
         > (*t
                                                TATIHIKT Of MUenCAL

                                                IP
                                                                       0*  
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 I'm * k P*O4(*4.IA * ID |Mto * f  * IVUMMI*  MM > 10 f* nw
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                                                IPmfTtB; *ta"  Ipf itKMMt ai nM* Han



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                                                      *MD CMf IDCAl M4t*M*
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                                         MM.    rt i * woctnew o POVMI LAW TO  TMP OBUCT m 4
                                                MCOWWTCHT WITM Iff
                 I* <9 m MM *m *  Mr. T **H
    4*^ ipn& ** w><* H^MNM w^ wM'^9 vnnv h> 'ffw<0

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                                                            ' tP * *f >*  *PPI >! K^ K^* ^- >"
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                                                CMTMMI* OlSPOtU.
                                                      . mii
                                                      WH
P 0 M*
     Tni^Pwt.MmcM tnat

-------
ATTACHMINT S

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-------
                  6ROMOXYNIL CONTAINER 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 TIMtFRAME CONSISTENT
 WITH THE APPLICATION FOR AMENDED REGISTRATION.  UPON FINAL EPA APPROVAL
 THESE STEPS WILL  IMMEDIATELY BE IMPLEMENTED:
DAY  I 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 8E PRINTED AND AFFIXED TO EACH CONTAINER
WITHIN RPAC POSSESSION, IN A MANNER CONSISTENT WITH THE "RELABELING
PROCEDURES" OUTLINED IK ATTACHMENT A.
DAY 4-10 FOLLOWING EPA AMENDED REGISTRATION APPROVAL

REVISED LABELS WILL BE DELIVERED AND STICKERING OF RPAC INVENTORIES
AT PLANTS AND WAREHOUSES WILL BEGIN.  NEWLY L J E M  II. I U '  W LL BE
RELEASED FOR SHIPMENT TO DISTRIBUTORS.

ADEQUATE QUANTITIES OF EACH APPROPRIATE LABEL, ACCOMPANIED WITH "RELABELING
PROCEDURES", HILL BE SHIPPED TO RPAC FIELD SALES REPRESENTATIVES FOR
IMMEDIATE DELIVERY TO DISTRIBUTOR WAREHOUSE LOCATIONS WHERE BROMOXYNIL
INVENTORIES EXIST OR MILL 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 "ftP 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 ARE RECEIVED.

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                BRONATE*/BUCTRIL*/BUCTR1L* * ATRAZ1NE
                   RELABELING COMPENSATION PROGRAM

 THIS PROGRAM  IS DESIGNED  TO  COMPENSATE THE DISTRIBUTOR AND RESELLER
 FOR RELABELING' HIS CURRENT  INVENTORIES OF BRONA1E*, BUCTRIL* AND/OR
 BUCTR1L** ATRA2INE BROADLEAF HERBICIDES TO COMPLY KITH 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 J10-GALLON MIN-I-BULK CONTAINER.

 CURRENT PHYSICAL INVENTORY AS OF 	
CASES
DRUMS
MINI'S
                                        TDATD
                           BUC7R1L*    BUCTR1L* * ATRAZJNE
1 HEREIN CITIFY THAT AS OF DATE SPECIFIED ABOVE, WE HAD IN OUR
INVENTORY THE QUANTITIES OF RHONE-POULENC BROMOXYNR PRODUCTS
AS LIsTEiJ AiiOVE, AND HAVE RECEIVED ADEQUATE QUANTITIES OF REVISED
LABELS FOR RELABELING ABOVE INVENTORIES.
BUSINESS NAME:
STREET ADDRESS:
CJTYs
COUNTY:
STATE:
ZIP
OWNER/MANAGER:
                        PHONE:
                       (SIGNATURE)
RHONE-POULENC REPRESENTATIVE:
                                                         ItKK. 9

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 DAY  I1-20  FOLLOWING EPA AMENDED REGISTRATION APPROVAL

 FIELD REPRESENTATIVES WILL  INITIATE DELIVERY OF APPROPRIATE LABELS TO
 EACH ACTIVELY SELLING BROMOXYNlL 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.
 RESELLS  WILL BE INFORMED  THAT NO BROMOXYNlL MAYBE SOLD PRIOR TO RELABELLING
 ONCE lABELS ARE RECEIVED.   RETAILERS WILL BE SUPPLIED WITH ADEQUATE
 NUMBER OF  LABELS TO PROVIDE TO GROWERS.  VERIFICATION OF LABEL DELIVERY
 HILL BE MADE BY RESELLER SIGNING THE "RELABELING COMPENSATION" FORM,

 EFFORTS TO HAND DELIVER NEW LABELS TO ALL RETAILERS WITH BROMOXYNlL
 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 BROMOXYNlL 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

                    BUCTRIL*. BUCTRIL*   ATRAZINE.  BRONATE*
                             EUBELINC PROCEDURE
  2I-6ALLON JUG

  1.  DEPALLETIZE CARTONS  (36 PER PALLET}.

  2.  USING THIN, FLAT METAL BAR, OPEN THE CARTON BY SLIDING BAR UNDER
     TOP FLAPS FROM MIDDLE OF CARTON TOWARDS END Of CARTON.  USE BAR
     TO BREAK CLUE SEALANT ON BOTH FLAPS BEING CARFUL NOT TO DAMAGE  FLAPS.

  3.  REMOVE NITRILE 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.

 .  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
     i-LAPS.

 9.  TAPE CARTON  CLOSED WITH COLORED  PACKING TAPE CENTERING  ALONG THE
     CARTON OPENING AND EXTENDED  DOWN BOTH SIDES 2-3 INCHES.

 .  REPALLET1ZE CARTONS IF  NECESSARY INCLUDING  RESTRETCH WRAPPING IF
     AVAILABLE.
        6

 30-CAUON  DRUM AMD 110-CALLON MINI-BULK

 PEIL BACKING FROM NEW PRODUCT LABEL  AND POSITION NEW LABEL OVER THE
EXISTING LABEL ON EITHER THE 30-GALLOW  DRUM OR  110 MINI-BULK CONTAINER.

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ATTACHMENT  C

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 RH&NE-POULENC
ftMdNI-POULCNC AO COMPANY
OFFICE MEMORANDUM
 TO:     Nick Sowna

 FROM;   Dave Downing
OAT:   May J, 1989
     Please find attached the Sromoxynil  label Amendment Communication
 Plan.  Our goal 1s to reach all  persons  who  sell, apply or recommend
 brorooxynil products within the agricultural  community In an orderly,
 logical and timely manner.  With this  In mind, we plan to first communicate
 new restrictions the day following  EPA approval to all RPAC Field and
 Office Personnel Involved with the  sale, promotion, development, field
 testing and distribution of bromoxynil products.  By the second day
 all bromoxynil product distributors will be  contacted with this Informal(on
 via overnight mall.  All resellers, university extension personnel and
 weed scientists will have bromoxynil 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
 will be contacted on a priority  basis  according to their past sales
 volumes as recorded by fthne-Poulenc.

     Following these written and  personal contacts, with those who will
 be called upon to provide Information, mass  communication to growers,
 crop consultants and farm managers  will  begin via radio spots, data-line
 information system, and point of purchase posters., Informing them of
 the new "Restricted Use" classification  for  bromoxynil products and
 to contact their local reseller  for detailed Information.

     Rh6ne-Poulenc feels that this communication plan will serve the
 intended need to alert the agricultural  Industry of the proper manner
 to handle and apply bromoxynil products  with minimal risk during the
 1989 use season.
 OPOrvwg
 Attachment
 cc:      J.N.  Harton
         S.A.  Schmotzer

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                BROHOXYNIL LABU  AMENDMENT COMMUNICATION PLAN
 UPON  RECEIVING  FINAL  APPROVAL  FROM THE EPA OF 1989 LABEL AMENDMENTS
 FOR COMMERCIAL  BROMOXYNIL  OCTANOATE FORMULATIONS, AND APPROVED COPY
 OF INTENDED  INDUSTRY  COMMUNICATIONS. RPAC HILL IMMEDIATELY INITIATE
 A COMPREHENSIVE PUN  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 MILL
 UNFOLD:
DAY 1 FOLLOWING EPA APPROVAL OF COPY

COMPLETE LABEL AMENDMENTS, WITH A COVER LETTER HIGHLIGHTING EACH PRECAUTION
AND RESTRICTION OF THE BROMOXYNIL LABEL, AS HELL AS A DESCRIPTION OF
THE PRODUCT RELABELING PLAN, WILL BE TCLEFAXED TO EACH DISTRICT AND
REGIONAL OFFICE. WITHIN RHONE-POULtNC AG COMPANY.

OVERNIGHT MAIL. INCLUSIVE OF IDENTICAL INFORMATION, WILL BE SENT TO
EACH FIELD REPRESENTATIVE WITHIN THE COMPANY. AS WELL AS APPROPRIATE
RPAC ADMINISTRATIVE AND PLANT PERSONNEL.
DAY 2 FOLLOWING EPA APPROVAL OF COPY

ANNOUNCEMENT OF THE BROMOXYNIL LABEL CHANGES AND THE PRODUCT RELABELING
PLAN 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 HEED SCIENTISTS.  AN ESTIMATED 3,000
TOTAL CONTACTS CAN BE MADE WITHIN TWO WEEKS.

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 PAY S FOLLOWIMC EPA APPROVAL Of COPY


 DIRECT MAIL LETTERS OUTLINING THt LABEL AMENDMENTS AND NEW RESTRICTIONS
 HILL 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.
 OAT 14 rOLLOWING 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 BUCTRIL*. BUCTRIL* + ATRAZINC AND  BRONATE* AND  0  Ni*. Ul  < M W
 TO SEEK DETAILED LABEL  AND  PRECAUTIONARY INFORMATION THROUGH THiIR 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/DISTRIBUTOR LETTER
 ATTWTIOK - LABEL CHANGES FOR 0RONATE*.  BUCTRIL* AND 8UCTRIL * ATRAZINE
 ThU  1 to  Inform  you  that  BRONATE*.  BUCTRIL*  and BUCTRJL* * Atrazine
 broadleaf herbicides  have  recently  been  reclassifled is  "RESTRICTED USE
 PESTICIDES"   end  that  the  labels   have  been emended  to  Include  fie*
 precautionary statements, additional protective clothing requirements, and
 new handling  and application restriction*.

 These changes  have  been  Implemented  because  recent tests  have shown that
 exposure to  the  active  Ingredient  1n  these  products  has  caused birth
 defects  In  laboratory animals.   The new label  amendments have been added to
 substantially  reduce  the  exposure  to  these product*  when handling  or
 applying.

 Enclosed you will  find copies of  each  new label for your  review.   Please
 take time to  become'familiar with this Information  in order that you are In
 full   compliance  with tech  Important  amendment.    Significant  additions
 Include:   1)  New warning  statement*;  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 chemtgetion and aerial  application restrictions.

 In an effort  to  assure  that  all  Inventories  of  BRONATf.*.  BUCTRIL* and
 BUCTRlL* + Atrazlne 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  Rhflne-Poulenc  will compensate  your
 efforts  at  a  rate of  $0.50/case, 30-gallon  drum  or no-gatlon  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  point-of-purchase  poster  for  hanging,  and  grower  handouts,  both
 alerting him to the label  changes  of  which he  must comply.

 Onee  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  Utter  (14 days for
 Retailers),   please  call   the   toll   free   Rhfine-Poulence   Hot-Una  at
 i-tOO-334-i?4$.  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.

-------
                         UNIVERSITY/CROP CONSULTANT LETTER
  ATTEXT10X -  LABEL CHANGES  FOR BRONATE*. 8UCTRJL* AND BUCTRlL* * ATRAZ1NE



  TMs  Is  to  Inform you  that  BRONATt*.  0UCTRIL*  and  BUCTRII* * Alrailne
  broedleaf  herbicides have  recently  been  reclassified as  'RESTRICTED  USE
  PESTICIDES"  and  that   the  labels  htvt  been  amended  to  Include  new
  precautionary statements,  additional  protective  clothing  requirements,  and
  new handling and application restrictions.

 These changes  have  been Implemented  because recent tests have  shown that
 exposure  to  the  active  Ingredient  1n these  products  has caused  birth
 defects In laboratory animals.  The new label amendments have been added to
 substantially  reduce the  exposure  to  these products  when  handling   or
 tpplylnf.

 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
 full  compliance  with  tech  Important  amendment.   Significant  additions
 Include:    2}  New  warning  statements;  2) Specific use directions requiring
additional  protective clothing  and  clean-up procedures; 3) The requirement
of  nechanical transfer systems  when handling 30  gallons or tore  product In
a single day; 4)  Use of  enclosed cabs when applying 180 or more  acres 1n a
single day; and 5) New chemlgation and aerial  application restrictions.

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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             GROWER LETTER TO BE AVAlLAQlC  AT  REStllCR LOCATION

 RH6NE-POULENC	
f a^^^BBBiiiiiii^^

 RHdNE-AOULINC AQ COMPANY


              TO: BUCTRR/BUCTRIL * Atrazlne/BRONATC*  Users


   BUCTRIL*.   BUCTRIl*  *   Atraiine  and  BRONATE*  herbicides  have  been
   reclassified   "Restricted  Use   Pesticides",   and   additional  label
   restrictions   and  precautions  have  been  added  to  minimize  user
   exposure.   '

   Please note  when  review  the revised  product labels  the following
   changes have been made:

      *    Warning  Statement:  This  product  has been shown to cause birth
          defects   in  laboratory  animals.  Women  of  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  BRONATC are registered  trademarks  of  Rh6ne-Pou1enc  Ag
   Company.
                                     .AM8*CnQAC *"C IDS

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               RADIO/DATA-LINE COPY
ATTENTION GROWERS!

BUCTR1L**  BUCTR1L* * ATRAZINE  AND  BRONATE* HERBICIDES,
USED  FOR POST-EMERGENCE  BROADLEAF  WEED CONTROL*  HAVE
               
BEEN RE-CLASSIFIED AS RESTRICTED USE PESTICIDES.
    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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       HOSIER 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 0
In lieu of the sentence which states/ "If this product is
packaged in a 30 gallon drum or you will har.-ile 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 has been fitted with a coir^atible 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 ot to modify youi
present sytem."

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ATTACHMENT  I

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                                                              5


     DRAFT   PROPOSED PROTOCOL:   BROMOXYKXi, EXPOSURE STUDY



 1.0   INTRODUCTION '

      A paasiva  doaiaatry  study shall ba conducted to  * tha
 daraal and  inhalation axpoaurs  occurring during routina ua of
 broaoxynil.   Tha atudy shall  ba dasignad so that tha
 Bnvironaantal Protaction Agancy aay ba aJala to:  (1) quantify the
 xposurs  occurring during  aixing/loading, application, and claan-
 up whan brovoxynil ia appliad by ground booa to fiald  crops
 vploy ing rigs whsrs booa  langths typically axcaad 30'; (2)
 quantify  tha axposura occurring during mixing/loading,
 application,  and claan-up  whan  broaoxynil ia appliad by ground
 boom to crops whara  rig* of 20*  to 40f pradoainata ; (3) within
 aach subgroup astiaata tha total potantial daraal axpoaura and
 tha  actual  dspositien ta tha  akin undar tha clothing worn by aaeh
 tudy participant.  A* an  additional objsctiva, this study or a
 aparata  study will  quantify  tha potantial damal axpeaura and
 sKin dapoaitien  occurring  during opar pour aixing and  loading
 with tha  naw Rhona-Poulanc 2.5  gallon containar and a
 convantional 2.5 gallon eontainar.

 3.0   MATERIALS AHD METHODS

      2.1  Sit*  Sal act ion

      Tha study  will address  two sain crop groupings.  Tha first
 grouping  shall ba crops to which daily traataants of ISO acras or
 nora art  typical and boon  sizas of 50' or gr'aatar ara tha norm.
 Tha  usual application apaad is  axpactad to ba approxiaataly 0.5
 acras/ainuta .  Tha sacond  grouping shall ba crops to which daily
 traataant of SO  to 120 aeras  is standard and boom sizas avaraga
 20*  to 40'.   Tha usual application spaad is axpactad to ba
 approxinataly 0.25 to 0.95 acraa/ainuta .

      Within aach grouping tha  sitas shall ba salactad basad on
 routina us a  of broaoxynil  or  othar aarly post ' aaargant harbicidas
 in that araa.  A ainiaua of tan a it as ara to ba uaad within tach
 grouping.

2.2  Cooparator  f alaetion             .      .   . _______________ ._

      Cooparators usad in  tha study ara to b* individuals
 intanding to apply a post  anargant harbicida indapandant of
possible  participation in  tha study.  Tha candidatss ara to ba
 salactad  in    aannar idantieal  to that aaployad in tha May &
 BaXar Canada/Rhona-Poulanc Study with tha axoaption that 
Biniaua nuabar of participants  with anclosad tractor eabs shall
 ba raquirad.   Tha quastionnaira  usad should ba siailar to that
 usad  in tha  Canadian atudy.   Ssltctad eooptrators will racaiva

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                             . 2 -

 bromoxynil in a manner idantical to a  non-cooparator who would t
 obtaining bromoxynil for hia/har uaa axeapt that breaoxynil y
 ba providad in a non-atandard containar  aa nacaaaary to
 affactuata tha study.  Rhona-Poulane may provida claan coveralls
 and nitrila glovas to study participanta.  Tha atudy participant*
 will initially ba inatnictad to follow Iabal diraetions.  Should
 tha participant atteapt to handla bronoxynii with laas than tha
 Iabal raquirad protactiva clothing,  Rhona-Poulanc will racord
 such daviation from tha Iabal diraetions and than raquire tha
 participant to utiliza all raquirad clothing.  Tha normal and
 typical  work routinaa of tha participanta ara not to ba altarad
 onca tha-study participant has bagun handling broaoxynil during
 tha monitoring portion of tha study*

 2.3  Application Dataila

       Information collactad for aach application of broaoxynil
 shall includa targat crop, data involving cultivar, growth staga,
 data of  planting, and row spacing.   Equipmant information shall
 includa  sprayar modal and maka,  tractor  modal and maka, procadura
 and tima raquirad to mix and load tha -aprayar and tha data and
 mathod of sprayar calibration.   Altaratiens to tha aquipmant aueh
 as  ahialding of booms and opaning of windows in closad cab
 tractors will ba racordad.  Application  rate and amount of active
 ingradiant handlad shall ba racordad as  will tha actual tima of
 application.

       Fiald conditions including wind  spaad and diraetion,
 ralativa humidity,  rainfall,  tamparatura, and cloud eovar aha11
 ba  racordad at aach monitoring sits  for  tha duration of aach
 monitoring pariod.   A description of aach tast aita will ba
 racordad.                   A

 2.4   Darmal Exposure

       Darmal  axposura to all  bcdy araaa  with tha axeaption of tha
hands will ba monitorad in a  mannar  that will parait tha
 estimation of potantial darmal  axposura  and darmal axposura to
tha  skin.   Potantial darmal axposura will ba monitorad by tha
 Durham-Wolfe  patch method (Measurement of Exposura of Workers to
Pasticidas,  Bull.  Hid 81th Org.,  192, 26:75-91).  Patches shall
ba placad in a mannar specified in Subdivision U of the Agency'a
Pesticide  Assessment Guidelines on tha outside of tha
eooparator's  clothing.   Darmal  axposura  to body araas covered by
clothing  shall ba monitorad using either vhola body dosimeters
composed  of a long slaava cotton T-shirt and long lagged cotton
underpants or by a fluorascant  tracer technique.  The vhola body
dosimeters,  if selected,  will ba provided to aach cooparator by
Rhona-Poulanc at laast ona day  prior to  tha study and shall ba
placad on aach eooperator,  by tha cooperator, at tha time that
tha  cooperator gats dressed to  perform tha day's work routina.
Tha vhois  body dosimeters ara to ba worn under all clothing

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                              3 

 normally worn by the eoeperatox-s.  Facial  exposure may be
 nonitored by the uee of facial swabbing in liau of doai&eterf.
 Hand exposure will ba monitored by uaa of  hand rinaaa.

       Tha monitoring pariod will oonaiat of tha handling of not
 laaa than 13 Iba ac.tiva ingradiant vith tha excaption that
 external patches will be changed and hand  rinaaa will ba
 conducted at the end of each six/load cycla and each application
 cycle.

 2.5  Inhalation Exposure

       Inhalation exposure will be monitored by uaa of parsonal
 air samplers.  Tha air samplers will b* turnad off during aach
 break in the vorX routine likely to axcaad  30  minutes.   The
 duration of tha sampling period should be the  entire day's work
 routine; however, caution must be taken to  prevent breakthrough
 from saturation of the collection media.  The  duration of
 stapling end calibration of air flov will be conducted for each
 eaaple  period.

 3.6  REPLICATIONS

      A replicate is defined as one monitoring period consisting
 of  the  handling of at least 13 ibs active ingredient.   The
 residue levels  of external patches for each body area and hand
 rinses  will be  combined in the calculation  of  total  potential
 dally exposure  tor each job function and the combined mixing,
 loading,  and application functions.   For each  crop grouping a
 Biniaua of  ten  sites are to be selected.  For  each crop grouping
 a miniaun of 30 replicates shall  be monitored.   For  each  set of
 20  replicates,  a miniaun of 7,  but no more  than 13 replicates,
 hall involve application from enclosed tractor cabs.   A  total of
 at  least 40 mixer/loader/appllcator replications will be
 conducted for the study.   Monitoring of the  exposure  resulting
 from  the use of the new 2.5 gallon container nay 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.   Zach set of 15  replications vill involve a
minimum  of  five individuels at  three different  sites.   A
replicate for this portion of  the study is defined as one
mix/load cycle  in which a spray tank is filled  to  capacity.

3.7  QUALITY ASSURANCE

      All quality assurance as  defined in Subdivision U of the
EFA's Pesticide Assessment Guidelines will be  required.

3.0  DATA ANALYSIS

      The purposes of  this study  ere to quantify the exposure

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                            - 4 -
received during the use of bromoxynil and the identification  of
           otion* that may be required to reduce exposure.
regulatory option* that may
      The data will b prentad as a an xpo*ur and a ran?*.
Th standard deviation -ill aUo b datanain.d.  Non-parametric
er otft.r Ippropriatt ttati.tic. *y b wployad to dateline tha
Statistical .ignitleanc. ot diffarant variabl.a in datannining
!auri   Major aophasU -ill > placed on tractor typa, be.oo
!??!  IJd tanX 5iia.  Po.t priori analy.e. ay ba conducted on
SiSIr ISJiaSla. Standing o? observed patterns in the data.  A
priori Jta?ii"c.l test. *ill.be defined in the protocol by the
         statistical ethods will test the following null
                                                              -


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: ''.' '''^f^^'4f~-' ~^-     ;   -          "        
  ;.  "^g^?-"'^yJc^. .3,^..'>;.>;.' ...;^..v->^  "-ttf

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I XJB2 ?    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 \.   ^                 WASHINGTON, D.C. 20460
                                                          OFFICE OF
                                                   PESTICIDES AND TOXIC SUBSTANCES
                          JUL  I 3 1987


 MEMORANDUM

 SUBJECT:  Compliance Strategy  for the Cancellatio
          of Carbon Tetrachloride

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

 TO:       Addressees


     Attached is the Compliance Strategy for the Cancellation
 of Carbon Tetrachloride.  The attached strategy provides
 guidance for the enforcement of the November 12, 1986 order
 which cancelled all pesticide products containing carbon                  I
 tetrachloride, except those registered for use on encased                 |
 museum specimens.

     This strategy is effective immediately and calls for
compliance monitoring  of the cancellation order through
 inspections of registrants, producers, dealers and users of
 cancelled products.  Inspections will  be conducted by States
 with Cooperative Enforcement Agreements, and EPA in States
 without Cooperative Enforcement Agreements, as part of their
 current routine inspections.

     We appreciate the comments offered  on the May 5, 1987
draft of this strategy.   Most of the comments  were editorial
and have been incorporated into the final document.  However,
one commenter suggested  that the strategy should also
address the disposal  of  any carbon tetrachl oride products.
OCM does not believe  that this issue should be addressed
in the strategy.  OCM recommends that  the disposal  of any
remaining stocks of carbon tetrachloride should be in
accordance with the label directions.

     If you  have any  questions concerning the  attached strategy,
please contact Dan Helfgott of my staff  at FTS 382-7825.


Attachments

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I



II
                            ADDRESSEES
Douglas D. Campt     (TS-766C)
Frederick F. Stiehl  (LE-134A)
Stanley Abramson     (LE-132A)
Peg Anthony          (EN-342)
Ken Shiroishi
Davi d Hannemann         "
John Martin             "
John J. Neylan III      "
Jerry Stubbs            "
Mike Wood               "
Dexter Goldman          "

Jake Mackenzie
Western Regional Compliance Director

A. Charles Lincoln
Eastern Regional Compliance Director

Louis F. Qitto, Director
Air Management Division

Barbara Metzger, Director
Environmental Services Div.
                     Gerald M.  Levy, Chief
                     Office of  Pesticides & Toxic Sub
                     Ernest  Regna,  Chief
                     Pesticides  & Toxics  Sub. Bran
III  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 3 Toxics Div.

VII  William A.  Spratlin, Director
     Ai r & Toxics Di vi sion

VIII Irwin L. Dickstein, Director
     Air & Toxic Subs. Division

IX   Jeffrey Zelikson, Acting Director
     Toxics & Waste Management Div.

X    Gary O'Neal, Director
     Air & Toxic Oivision
                     Larry  Miller,  Chief
                     Toxic  &  Pesticides Branch
                                                                     n^i
                     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  
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                  COMPLIANCE  STRATEGY  FOR  THE
              CANCELLATION OF CARBON  TETRACHLORIDE
OVERVIEW
     In 1984,  the Agency suspended all  registrations  of
pesticide products containing carbon  tetrachloride,  except
those products registered for use on  encased museum  specimens,
after registrants failed to respond to  a  FIFRA 3(c)(2)(B)  Data
Call-In.   On July 23,  1985, the Agency  issued a Stop  Sale,  Use,
or Removal  Order (SSURO) to all registrants  covered  by the
suspension  order.  This SSURO stated  that registrants may  not
legally distribute, sell, offer for sale, hold for  sale,  ship,
deliver for shipment,  or receive and  (having so received)
deliver or  offer to deliver pesticide products containing
carbon tetrachloride after the date of  receipt of the SSURO.
Registrants who later  agreed to voluntarily  cancel  their
registrations, as well  as all persons who sell or distribute
pesticide products containing carbon  tetrachloride,  were
allowed to  distribute,  sell, offer for  sale, hold for sale,
ship, deliver  for shipment, or receive  and (having  so received)
deliver or  offer to deliver carbon tetrachloride  until December
31, 1985.  Stocks were  allowed to be  used until June  30,  1986.

     On November 12, 1986 (51 FR 41004),  the Agency  issued a
Notice of Intent to Cancel (NOIC) for all remaining  suspended
registrations  of pesticide products containing carbon tetra-
chloride  except those  products registered for use on  encased
museum specimens.

     Carbon tetrachloride was present as  an  active  ingredient
in pesticide products  registered for  use  as  fumigants on  stored
grain, in flour milling and grain processing plants,  as  well  as
on encased museum specimens in storage.   All registrations  for
pesticide products containing carbon  tetrachloride  as an  active
ingredient, except for  use on encased museum specimens,  have
now been  cancelled.

     Carbon tetrachloride poses significant  toxicological
risks, and may contribute to the breakdown of the atmosphere's
ozone layer.  The use  on encased museum specimens will  be
allowed to  continue because the current label  instructions are
sufficient  to  reduce applicator exposure  so  that  the  benefits
outweigh  the risks.

     Compliance with the Cancellation Order  will  be  determined
through inspections of  registrants, producers, dealers,  and
users of  cancelled products.  Inspections will be conducted by
States with Cooperative Enforcement Agreements, and EPA  in
States without Cooperative Enforcement  Agreements,  as part of
their current  routine  inspections.

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                              -2-
REQUIREMENTS OF THE RULE
     All pesticide products containing carbon tetrachloride,
except for use on encased museum specimens, were cancelled
thirty days after publication of the NOIC or the date of
receipt of the Notice by the registrant, whichever date was
1ater.
Regu1ated Indu s t ry
     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,
and
 Carbon tetrachloride is also known as perch!oromethane
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).
      ANCE MONITORING
     Compliance with the Cancellation Order will  be determined
by inspection of registrants and producers of cancelled products,
inspections of dealers and users,  and investigation of tips  and
complaints.

Neutral Administrative Inspection  Scheme	

     Since the issuance of the Cancellation Order is an admini-
strative action which cancels all  carbon tetrachloride pesticide
products suspended for noncompliance with the FIFRA 3(c)(2)(B)
Data Call-In, inspections for violations of this  cancellation
order will take place within the existing compliance monitoring
framework.

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                              -3-
ALLOCATION OF RESPONSIBILITIES
Office of Pesticide Programs
0 Will develop and provide OCM with a list of those products
  which have been cancelled.
Office of Compl iance Mom'tori ng
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)

Uniroyal  Chem.  Co.
74 Amity  Rd.
Bethany,  CT Q6525
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.8.  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,-l1,-31,DC3800010Q

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.
Minneapoli s, 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. Louis 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

 Weevll-Cide Co. a subs, of Research Products Co.
 411 N. 7th St.- Box 1057
 Sallna, 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. Oiv 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

Falls Chemicals  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.
 Brisbane, 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. Foothill Dr.
 Yreka, CA 96097
 EPA Reg. No. : CA79027400
                           REGION X (1)
Atomic Chem. Co.
Box 1111
Spokane, WA 91210
EPA Reg. No. :  6152-5.-6

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K* ;>*, 3

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                i
                it
                    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                    WASHINGTON. D.C. 20460
I/
                                         JAN 15 1976
                                                                OFFICE OF ENFORCEMENT
            SUBJECT:  Enforcement of Administrator's Decision and
                        Order Suspending Most Uses of Heptachlor and
                        Chlordane  '
            TO:        Enforcement Division Directors
                        Pesticide Branch Chiefs

            FROM:     A. E. Conroy H, Director
                        Pesticides Enforcement Division (EN-342)
            I.  LEGAL DEVELOPMENTS
            istrator on the Suspension of Heptachlor-Chlordane (In re Velsicol
            Chemical Corporation,  et al. , FIFRA Docket No.  384J ordered 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:'consii'cuent
            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
V,-
            *  Copies of the Administrator's "Conclusions" and the "Order" are
            attached.

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                             -2-
 29. 1975, "Notice of Intent to Suspend" remains in abeyance in the
 Sixth Circuit as well.
                                                       

 H.  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 formulatorj and 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 ^uspension to subject registrants.

       Until that tirr.e you may find it helpful to deal with general
inquiries as follows.
of
1) So far as FED is able to determine at this time,
                          *,vhich were formulated
                             """*  "^ "r "CLP-
          975. are illegal for
            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 \d,th directions
provided by the Office of Solid Waste Management.  Disposal questions
may be referred to Ray Kreuger in Washington at (202) 755-8050. Regional
offices should cooperate in every way possible with responsible efforts to
dispose of suspended chlordane /heptachlor stocks.

            3) Questions relating to label status should be referred  to
Tim Gardner of the Registration Division, Washington,  (202) 426-9425.
As soon as firm policy exists as to this issue you will be informed of
its substance.

            Should you have questions concerning any facet of the
chlordane /heptachlor suspension, please contact the appropriate
coordinator.

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     *   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

   .<                     WASHINGTON. D.C. 20460
   '
                             JAN
                                                        
                                                    OFFICE OF ENFORCEMENT
SUBJECT: Clfci'-iciJiir. of Ecptachlor/Chlordane
           Suspension Order

TO:        Enforcement Division Directors
           Pesticide Branch Chiefs

FROM:    A. E. Conroy n. Director         '       Jtf/ L
           Pesticides  Enforcement Division (EN-342) /S <*


   Please find attached a copy of the Administrator's "Clarification
of Order of December 24, 1975 (In re Velsicol Chemical Corporation
et al., FIFRA Docket No. 384), " dateu January 19, ia7b.  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 AMERICA
               niVIROKMEIITAL  PROTECTION ACEfJCY
                  UEFORE THE  ADMINISTRATOR
   
col  Chemical Corporation
           Registrants.    \
                                   ,   .FIFRA Docket Mo.  384
                      CLARIFICATION OF .
                ORDER OF  DECEMBER 24, 1975
     C* January 7,  1975,  Respondent  EPA filed--a  Suggestion for 
 {Unification of the Order  of  December  24,  1975, in  the above-
                                                  *       .  
 <*/-'.ur.od proceeding, seeking  clarification of the uses of
 jr^.-cts containing heptachlor and chlordane for which
 *r iterations are not suspended by the  December  24 Decision
 *: Cr-Jcr.  Respondent also submitted a Proposed Order, including
 4^ 4*.uctacnt setting forth a  proposed  list of uses  not suspended,
 'i-;?:/.cr with certain explanatory notes.                 .   
     On January 13, 1976 I'issued a notice of the filing of
 ''WftJent's Suggestion for Clarification and Proposed Order
               written consents from the parties,  thereby
              intention to  consider the possible need for
 :*'ticfqn of the December  24. Decision and Order.*  On  '. "
s4*ry lst  1976,'written comments were received from counsel for
*Hft9l  Chciaical Corporation;  counsel  for  the Pineapple Growers
            of Hawaii and the Attorney  General and Department of
                   -7
-;.r.^  ?-coraonts ^n response to Respondent's suggested
'-"- "r[t"t.    v>vre submitted by counsel for Velsicol Chemical
   ''" Oanuai%y 12 19?6 but not sufficiently in advance of
               of the January 13 notice to be considered  therein.
                                                                           r

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 Agriculture of the State of Hawaii; counsel  for  some  300
 registrants of various products containing  heptachlor or  chlordane;
 the Environmental  Defense Fund; the U.S.  Department of Agriculture;
 and Respondent EPA.  All of the foregoing parties, except the
 Environajental  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. OrderJ s_ final...and .caiwot.nov/,.he. - -
                                    -                      .
                                       *        '      '".'
 changed .in the manner proposed by Respondent.
      Even though not expressly provided  for in the Rules  of
 Practice governing expedited hearings under the  FIFRA,  I  have
.determined that authority does exist to  clarify  the  December 24
 Order and that some clarification is warranted,  in view  of the
 apparent possibility that its provisions may be  unclear.   In my
 view., the December 24 Decision and Order are clear and specific
 in their terms and should not require any further elaboration.
 Implicit in Respondent's suggested clarification, however, is  the
                                     *                              "
 notion that proper administration of the Decision and Order by
 the Agency and explicit understanding thereof by all  the  parties
 require a clear statement of the uses of products containing
 *      *                         _                            *     * * 
 heptachlor and chlordane for which registrations have not been
 suspended.  In an abundance of caution and  concern,  therefore,
 I  believe proper administration of the Decision  and  Order will'be
 served and facilitated by the following  clarification of  the..
 December 24 Order.           .                               -^
I
f.

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                               3                                  .

      In revievnng the Decision and Order and  the possible need               .
  

 for clarification, I have not considered any  new evftiuuc* or     "      .   v

 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 tims I issued the Dscisibn  and Order.  Cc-ransnts

 received from the parties have been most helpful- in determining
                           .                            *    "              *
 whether or not my intentions were clearly expressed.  The sole

 purpose of this clarification is to add clarity  to the expression  .


 of my intentions at the time I issued the December 24 Bccisieii    '


 and Order.             .           -    '       ..          *.'*"..  ""     '
                                .                                *.-*

      The December 24 Order, by its terns, 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 homeowners and by pesticide  control operators),

 (3) against ticks and chiggers, and (4) as a  constituent in         . 
                   '                                                     
 shelf paper, are suspended [the suspension of products  for  use on   .  ,.
.           '                                     .                                   i
 corn having a post-effective date of August 1, 1976].  The  Order                 ;


 further provides that any stocks of technical grade heptachlor   ...      .-     (

                                        '                            -             '--I
 or 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 ttovejnber/i.lSr 1974, cancellation order] or_         '     :*     '  ; >
           .-:.   ,  '-,. :---:.;'.;,    -                                                 j
 specifically permitted in1Accordance with the Decision of the                    |
                                                                                   
 Administrator attached thereto. .                      .  <     .                     t
  .                                  '-                    -                    'V
:-      .   .        ....'..-,      .   .    '          .                             J
                         . '       .. '    '             *                               
                                                                   .               t
                                                                                 .. r
                                                                                 . i
                                                                              if- r

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c
      .Ths uses specifIcaUy permitted or continued by the
  Decision accoiupanying the December 24 Order include or.ly those set
                                                                           
  forth in paragraph 4 of the Conclusions contained in the Decision*
                                                                 *   -
  and, therefore, these uses (together with the exempted uses for
  subsurface ground injection for termite control and dipping of           t       \
  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 hcplachlor or chlordans are  
                                                          **
  suspended.  Because  the words "intended for such uses"  in line  12
  of the Order might be interpreted as Halting 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                 "\
                                          *                            .            I
  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 recommended  that such  other  uses  not be  continued,  and
                                         *                       .
  ?Decision of  the Administrator,  p. 76	
                                                                                         t
                                 * .
                                *  *        - "*: ;.*-

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                                s                           -.-...



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



  Order are arco:ir tl-  vses  as to which sufficient benefits evidence

                                      *

  IMS presented at the haariny to permit a risk-benefit assessment.
                                                               


  Ulanket suspension of uses as to which there v/as little or no



  evidence on benefits was  necessary because the" evidence on



  carcinogenic*Ity risk v/as  applicable to all uses.  In view of the

                                    

  risk so established, and  in the absence of .sufficient benefits

            *                   * '

  evidence.as to uses  for "any other purpose," it was of course



  necessary to suspend such other uses, even though (for the reasons

                    -                         '

  indicated above) they could not bs enumerated specifically in the



  Order.  . "           .             "' '                "            ; '



       As to the grouping of uses on "certain fruits and vegetables



  and other miscellaneous crops" [referred to in paragraph 5 of the



  Conclusions in the Decision], it v/as my intention, that the 	
                                                        *  '     *


  provision in the Order applicable to uses for "any other purpose"



  apply as well to this grouping of uses.  In stating that "the



  record in this proceeding is not sufficient to reach a conclusion"



  regarding this grouping of uses,* I stated only that the evidence



  on benefits was insufficient to permit the kind of discussion of

           .        

  the risk-benefit assessment which I had used for better documented
                            *                                   "
                                  

      .  Therefore,  with respect to this grouping of uses, I reached



      tame ultimate  conclusion as discussed above concerning uses  for
  *  Vision of the Administrator, p.  76.
                                                         i  .
            **

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         "any other purpose" generally, jje..tliat, in view of the
       .evidence on carcinogen!city 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
                                          
                         *                                           .
         Dscision and the provisions of the,Order.                .      .
              In view of the foregoing,'! do not find it necessary to   '
       - either-nadopt oP-^cject-th -Proposed.JOwUai
                                                          Russell  E.  Train
          Datetl:   January 19, 1976
                                                                                         r

                                                                                         1..
                                                                                          '. 
                                                                                           t
                                                                                           I
C


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4  ?
V

"
* . 
 
*
*
COMPOUNDS)
chlordane It
heptaehlor 
chlordane &
heptaehlor
chlordane &
' 4
heptaehlor
- 4
heptaehlor
heptaehlor
heptaehlor 	
 * '
chlordane
cMordane
.
ehlordane
/ ATTACHMENT A -I
SPECIFIC USES OF Cm.OnDANI* f. m:PTACm.Oll - -.1
NOT SUSPENOOJ UV ALV.'IKlSTllATOU'S OUDEIl OF 12/24/75 j
1
US(S) -STATUS OF USE(s) [ i
Subsurface ground insertion for termite control
Dipping of roots or tops of non food plants
Control of cutworms on corn (both pfe and post
emergence)
Control of narcissus bulb fly
Seed treatment
"~ Ant control To achieve pineapple' mealy bug .'""
5
control in Hawaii
In Federal /Slate quarantine programs for
6 .5,6
Japanese Beetle and imported fire ant
Control of black vine weevil on Japanese Yew
in Michigan
Control of Texas harvester ant in Oklahoma '
continued . k
continued ' .;
continued until '
8/1/70 only . " '
continued
 continued
continued
 '
. 

continued  ,
. .i

continued
continued
*
t'
".
W
:

i
          chlordane
                    Control of imported fire ant by private
                               5.'
                    individuals
continued
          chlordane
                    Control of white fringed beetle attacking food

                  i crops   InSS.E. States (AL.FL.GA.LA.MS.NC,
                    SC, TN)
continued
          chlordane
                    Control of soil insects  attacking Florida citrus
continued
          'chlordane
                    Control of strawberry root pests by prc-plant        continued
                    treatments                                        '
          chlordane
                    Control of white crubs in Michigan
continued
                                                                                                       r .
 l   All registrations (Federal and s;ate) 01 pcsucioe products containing ticpiadilor ana
     chlordane for uses not specifically continued are suspended by the Administrator's
     Decision and Order on the Suspension of Hcptaehlor-Chlordano.. The effect of the
     Order is' to further prohibit the manufacture* formulation or reformulation of products
 ; ' . containing Heptaehlor 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 registcrcd''products which were formulated prior to July 30,  1975
     are permitted' for both continued and suspended uses. ...... ------  r"  " ~~.
2.'  PR No lice. 74 -11  (39 FR 4 r298) exempted thisiuse from cancellation.  Such use
     was similarly exempted front the Notice of Intention to Suspend.  40 FR 34456
     (7/29/75).           .-
 3.   Clarified at 40 FR 30522 (7/21/75) to apply to the use of tmulsifiable or oil
     concentrate formulations for controlling subterranean termites on-structural
    .sites such as buildings, houses, barns, and sheds, using current control
     practices.    >                            .                         *
 4*   Velsicol has represented that it would voluntarily suspend domestic shipments
     of hcptaclUor for this use ponding resolution of the cancellation proceedings.
 &.   On Urc assumption that f.Mrc.x is not available. . 
 0.   To Include treatments required to certify to pest-free conditions as well as for
 -  -  use in suppression and control programs.     .-            - ----  _, _.
 7   To include use oii both public  and private property by cither owner* agent.
     employee,. or contractor.        .    "       -        .". v'   '".,                 .
 8*   Not Intended to preclude use on cotton* However; uce oh 'tobacco is suspended.     ' .
 9.   Restricted to citrus root weevils*      ":>'        ''"','                          '*
                          b
                          "
                                                                                                          I    !

                                                                                                          I    ;
                                                                                                          I.
                                                                                                          ir


                                                                                                          I
                                                                                                         . \'

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         UNITED STATES ENVIRONMENTAL PROTECTION AGENCY -
                         WASHINGTON. D.C.  20460
                              -619 1976
                                                            ENFORCEMENT
SUBJECT:   St&Hts Report on the Hcptachlor/Chlordane Suspension

TO:         Enforcement Division Directors
            Pesticides Branch Chiefs

FROM:     A. E.  Conroy n. Director
            Pesticides Enforcement Division
    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 425 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_bc sold and distributed if the  reg-
istration is provisionally amended.         ~                 -  '    ~

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

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r
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                  WASHINGTON. D.C. 20460
                   CERTIFIED MAIL
                   Gentlemen:

                   Subject   :  Notice of Suspension for:
                  "On  December 24, 1975, the Administrator issued his Decision and Order
                   on  -the .suspension of Heptachlor and Chlordane.  Host federal  and state
                   registrations of Heptachlor and Chlordane were suspended although
                   certain uses were specifically exempted, (Refer to the enclosure).   Any
                   registration which  included a suspended use was suspended effective
                   December 24, 1975.  This letter is to notify you that your 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 fimply discontinue the use of Cfclordane
                  * or  Heptachlor in the formulation of your product.  If you select this
                   approach you will not be required to submit -a petition for an amendment
                   'if  your product contains no other insecticides and all insecticide claims
                   are eliminated.  If other insecticides are contained you must apply for
                   an  amended label which in certain instances jnay require new efficacy
                   data.  If you wish  to continue to formulate your product with either
                   Heptachlor or Chlordane you may continue to do s,o only for uses not
                   'suspended and only  after you have submitted a petition for a label
                   amendment in which  all references to suspended uses have been deleted.

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                    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                     '   '              WASHINGTON. D.C. 20460
	        CERTIFIED  MAIL
             "    '"*:..  *


  .:.      'i..   -X';- : ;

 "* ,.  "  ',  '  ."- ."..' ' . ;       
.       .-  ' .  ' .'    ..'...
                                                                            '; i 
                    	.  ...  -f- '.    .  .-.
               .1   .   .......     ...  ..  .
     .. -.-.  -.-.v,.*-.--.;....i
     % * -  t *     ," *   * *."*
            Gentlemen:   '      .'  '..  :-  *.'  '    -

            Subject  :   Notice of Suspension for:
           .'"'. \
             \   *..,-. -w.i .- w-^.
            c  +*.  *
                      <   ' *
            On  December 24, 1975, the Administrator issued his Decision and Order
            on  the suspension of Heptachlor and Chlordane.  Most federal and  state
            registrations of Heptachlor and Chlordane were suspended although
          ,  certain uses were specifically exempted (Refer to the enclosure).  -Any
            registration which included a suspended use was suspended effective
            December 24, 1975.  This letter is to notify you that your subject
            registration contained a use suspended by the Order and therefore has.
            been suspended effective December 24, 1975.              :

         *  If  you wish to be permitted to continue to formulate and/or sell  Hepta-
            chlor and/or Chlordane for uses not suspended, you will be required  to
            petition for a provisional 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 have;.been ^blocked'outv': The granting by-the Agency  of  such
            a petition will permit.ypujtp;c&ntinue.formulation and/or sale of Hepta-
            chlor and/or Chlofdane*'"forrexfeinptted 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:
         '_ *m                       
            

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                           -"       '        -':     C
                          .'I                   '       .  .     '              '        V-
                           \
7-         \SX\bL*   UNITED STATES ENVIRONMENTAL PROTCCTiON AGENCY

                                        WASHINGTON. D.C. 204SO   '       .'  "'
                 -                                              *

                  '              '     .*'.'         '      .        ."'..

                CERTIFIED MAIL     "         ""   '          "    .  .! .  .   '*   -'  -
             :.  Gentlemen:       .             .

            "  Subject  :   Notice of Suspension for:
                                                             .        

               This is to notify you that on Decenier 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  or, jwed after  July 29;  1975..               *
               .            '   *                   .                         *        ^
             *   *         .,"',"                 *

               The Admin1strat6r:.'s Decision and  Order wi 13  be pub!ished'1n the Federal
             /(tegister^in/the^riear^futur^    f     '   ^ .  ';


               Sincerely'yours," ':  /  '"" '-'"'"''*'''**"'.- '''':- '^3-';-^.j. !-.."l-;:_.

                ""        "'
              John B.  RitcK; Jr. '"/.''
              Director                  "
              Registration Division (tm-567)   "

              Enclosure

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       __	                      .                .2-
                       *                                    *
          ___;__     It is sufficient to send a cover letter with an amended label  or
(        ""         in 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 nrust 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.
         '  "                                                                         p
 	     	.    .  The amendment. wij.l_not .abTO^a.tc_yiujr^jdght_to~dofend--beth-5U5peflded-'-or
            	  "  nohsuspended 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
 s      '           July 29, 1975, may not be shipped or sold until you receive EPA
                   of your amended label.                                  .
 \                       m                                                          .

                   The Administrator's Decision and Order will be published in the Federal
                   Register in the near future.    .               .        .
     *        "    -  *                                                 *
                   Sincerely yours,                            "'-,*
                   John B.  Ritch, Jr.
                   Director
               7   Registration Division  (WH-5677

                   Enclosure      '        
            /                                   
                                                                                         '  i
  c

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                        siT.anc USES  or CIILORDANK t- nnr-
                \   NOT SUSJ'EN'DEO BY AD.\UN(STKATOK':: O;'.iJi:il OF 12/24/75
X
c
COMPOUND(s)
ehlordane &
hepfachlor
chlordane &
heptachlor
chlortiane &
4
heptachlor
4
heptachlor
heptachlor
oeptachlor

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
5
control In Hawaii

STATUS OK USE(s)
2.3
continued
continued
. continued until
e/I/76only
continued
continued
continued
f < *

chlordane
                                    In Federal/State quarantine programs for
                                                    6                    5.6
                                    Japanese Beetle  and imported fire ant
                                                                       continued
chlordaoe
chlordane
chlordanc
Control of black vine weevil on Japanese Yew
in Michigan
'Control of Texas harvester ant fn Oklahoma
Control ol imported fire ant by private
5,7
individuals
continued
continued
continued
chlordane
                                     Control of white fringed beetle attacking food
                                           8                             .
                                     crops  in & S.E. States (AL..FL,,GA.LA,MS.NC.
                                     SC, TN)
                                                                     continued
chlordano
                                     Control of soil insects   attacking Florida citrus
                                                                     continued
chlordane
                                     Control of strawberry root pests by pre-plant
                                     treatments
                                                                     continued
*. ehlordane
  *
                                     Control of white crubs in Michigan _ continued
                                      u cocral anc ataieJ ot pesucioc products containing ncpucnlor and
  4.

  5.
  6.

  7.

  8.-
  9.
    Ail registration
    chlordane for uses not specifically continued arc suspended by the Administrator's
    Decision and Order on the Suspension of HepUchlor-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
    axe permitted  for both continued and  suspended uses.                '   .
    PR Notice 74-11 (39 TR 4I2?3) exempted this use from cancellation. Such use
    was similarly  exempted from the Notice of Intention to Suspend. 40 FJl 34456
    (7/29/75).       -v. '.-.-                                                  -
    Clarified at 40 FR 30522 (7/21/75) to apply to the use of emulsifiabte or on
    concentrate formulations for controlling .subterranean  termites on structural
    Bltco such as buildings,  houses, barns, and sheds, using current control
    practices.                                                 
    Velsicol has. represented tliat it would voluntarily suspend domestic shipments
    of heptachlor for this use pending resolution of the cancellation proceedings.
    On the assumption that Mir ex is not available.  '    '               .
    To include treatments required to certify to pest free conditions as welt as for
    use in suppression and control programs.  ''
    To include use on both public and private property by cither owner, ancnt.
    employee, or contractor.'                           .                        -  '
    Not intended to preclude use on cotton.  However, use on tobacco is  suspended. -   *
    Jtcstrictctl tojcitnis root weevils. .     .                .                    :
           *   *^               .'.:           '  -            .        '



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                                                              J> .
            '/     "      Mr. Timothy A.  Gardner           ".'".
    .      . ;    .  -        Product  Manager (15)              '  ", ''.-"'
               .;        Registration Division (WH-567)         '      .   .'
          .     "    '    Envirorcnental Protection Agency
                         V,'iMngton, D.C.  20460.

 The amendment will not abrogate your right to defend both  suspended or
 nonsuspended uses in the continuing cancellation proceeding.

 Existing stocks of EPA registered pesticides containing Heptachlor or
1 .blordane jnay, .bfi_ <
 stocks-were 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,
 toay only be distributed and sold for those exempted uses included in the
 enclosure and under labels  containing no suspended uses.   Stocks which
 you may  presently have on hand, if manufactured or formulated after
 July-29, 1975, may not be shipped or sold until you receive EPA approval
 of your  amended label.       ..              ..."    '       -  ...'	"-   
          *                                                       *

 The Administrator's Decision and Order will be published 1n the Federal
 Register in the near future.  .                 .
 Sincerely yours,
 John B. Ritch,  Jr.         .  .
 Director          .    '.''.'"'
.Registration  Division (WH-567)
                            .  .
 _  ,             .."...
 Enclosure          ..   .
                                                               .-^  
         .         .                                           .
  . ... tv...  .-.     --." v .    ;:-'-*-.'.  .  .. :,.   -  ..-'.
  .. .  . . | .. ;   i.  ' < -  . i  :. f. ' j.~*    .  -  .      -         .      **   ,,
 '  ,  '  .! -. .. -.-i;'-.'i ;;:" V--.'  -^ &  ' -    ;  '    "' '' '    *'  ' * -  * '
    ''''   '
                            ...
          *. !-  ''.'. ''  ;*i:-V .*":
           ."-.."'   .  ''>.    -'.';'!' ^j-7'-^    .. i -...".';..-. ^'-;:.'./'  '..  ;--.
         ':-  ".;:..'; ^'il-.''""  .  . "-J. '-^Ift-:'.    '.''..'."'   *::'>'^''':.'""..	_.r..uJ	

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(* *ffc  \
 m
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

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

    TO:,    ,_ Enforcement Division-Uir^ctocs	....  .
               Pesticide Branch Chiefs            ^~*

    FROM:    A. E. Conroy II,  Director
               Pesticides Enforcement Division
         In my memorandum of February 19,  1976 regarding the status
    of Agency activity on .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 12/24/7T1"for the list of uses
           exempted] were suspended as of December 24, 1975.

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                               -2-

      (2) By invoking the "Special Rule" provision of section
         15(b)(2). the Administrator has provided that stocks of
         EPA registered pesticides containing heptachlor or
         chlordane formulated prior to July 30. 1975, may be sold,
         distributed, or used for suspended uses.

      (3) Stocks of heptcicMor  or chlordane products formulated
         rlter  July 29,  1975 may be sold, distributed, or used
         only for exempted uses, as per "Attachment At!.
 H.  CATEGORIES OF HEPTACHLOR/CHLORDANE PRODUCTS     _ -.-

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

     (A) Federally registered products, all uses of which have been 	-
 suspended.  The Registration Pi vision/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.  I / 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	
 suspended  As noted in the introduction and in previous memoranda,  ~
 to ere 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 product's
 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
 if see my* eoruary 19, 1976 memorandum entitled "Status Report on the
"Heptachlor/Chlordane Suspension. " and its attachments.

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                            -3-
 registrants of 140 "intrastate'1 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 uf-rgg'isU ants as to "thair* products' "status:
 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.              	
m.  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 29ththose
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.- 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 recallin some instances for1 relabelingof
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 F ederally registered
 products.


 IV.  ENFORCEMENT ACTIONS.

     As has been the established policy in such matters, enforcement   ~
 actions will be taken, in accordance with normal procedures and at
 levels consistent with those provided for in the Pesticides Enforcement
 Division Case Proceedings Manual, against all persons found in viola-
 tion of the heptachlor/chlordane suspension order.               - 

     There exist a number of enforcement action options available to - -*.-
 ensure compliance with the Administrator's Suspension Order.  As - --*--
 previously stated, the Agency has determined that a national recall	 -
 of violative products would be the most effective and efficient means "
..of ensuring compliance with the suspension-order. Because of, the _.,
-extra-ordinary number of products and-firms which are affected by- --- -
 the December 24th Order and the commensurate amount of Agency  .*
 resources which would be involved in-conducting a formal  recall, -the-
 Agency feels that the procedures outlined in the Case Proceedings
 Manual.  Chapter 12, for informal recalls would be more appropriate
 in this matter. Information and guidance with respect to specific en-
 forcement related actions which may be directed toward each of the
 aforementioned categories of heptachlor/chlordane products follows:...

     (A) Federally registered products, all uses of which were sus-
 pended and wmca were formulated alter July 29, ^75.  As per recall'"
 initiation procedures, the Pesticide Enforcement  Division has notified
 by certified mail those registrants who had all uses of their heptachlor/
 chlordane product(s) suspended by the December 24th Order* that EPA
 is requesting that all subject  products formulated after July  29, 1975v
 be recalled immediately.  This letter.-5t copy of which is attached to
 this memorandum, refers the addressee, to the Registration Division
 suspension letter informing the registrant of the registration status of
 his product(s), and-continues by specifically requesting that  (a) the	
 company initiate procedures to  determine the locations of all quantities-
 of their finally suspended product and the amount  of such product at
 each such product location, (b)  that the product be returned to the
 registrant from all locations, and (c) that the named regional contact
 person be informed of all actions taken in connection with the recall.

 In your follow-up to determine compliance with the recall request, you
 should:

       (1) be assured that the registrant has recalled the product
            from the retail level, and either

            (i)   disposed of the product.

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                               -5-


            
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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 /
                           t
     (C)  Intrastate  products.  The policies outlined above will also
apply, as appropriate, to intrastate products as they become identified.
At present,  the 48 products thus far identified will be treated the same-
 category A products].

     Now that all parties affected by-the Administrator 's Decision and
Order in the heptachlor/chlordane suspension proceedings have been - -
duly notified of this action and of their obligations attendant thereto,
the Agency places the highest priority on assuring full and immediate -'
compliance.  The initiation and follow-up of the heptachlor/chlordane
recall herein authorized will represent a significant addition to* exist-
ing regional enforcement burdens.  It is anticipated that regions will -
exercise initiative and energy in performing,. in addition to program--
med outputs, the surveillance,, inspections,- enforcement actions, -and
routine follow-up necessary to implement this recall.

     The region should report the. following information to the appro-
priate regional coordinator as soon as available:
                                                   *             
      (1) the number of firms subject to-recall;       -

      (2) the amount of each product recalled; and                   ~   *

      (3) the methods of actual or planned disposal
         of recalled material.


V.  DISPOSAL OF HEPTACHLOR/CHLORDANE PRODUCTS

     Persons desiring to dispose of stocks of heptachlor/chlordane
should be apprised vthat 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 Kreuger, 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.
                1 n.

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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,


VH.  INQUIRES

     Should you have any questions concerning any facet of this memor-
andum and  the heptachlor/chlordane suspension order, please  contact
the appropriate regional coordinator.-Questions relating to registration
and label status should be referred to Mr. Tim Gardner, Registration -
BtvistotrrOffice- of-Pesticlde-Pr ogr3ffls^t202} --SZ&z&ttSf.	 ------


VIE.  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.~TT~"             .

       (2)  Copies of recall request-letters senfrto 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. et al., Consolidated Heptachlor/Chlordane Hearing. "

       (5)  List of Federally registered heptachlor/chlordane pro-
           ducts,  all uses of which have.been suspended [category
          -.A products] was mailed by PED to the regional pesticide.
         .  branch chiefs under separate cover March 17, 1976.     " -

       (6)  List of the 48  "intrastate".heptachlor/chlordane products,
           .all use of which were suspended [category C products].   '---

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                                                                                1
        UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                        WASHINGTON, D.C. 20460
                     27AU61976
                                                    OFFICE Of ENFORCEMENT
TO:     Enforcement Division Directors
         Pesticides Branch Chiefs

FROM: A. E. Conroy II, Director
         Pesticides and Toxic Substances
         Enforcement Division (EN-342)

RE:     Heptachlor/Chlordane Suspension Or\ier
         Enforcement Strategy  CORN USE
     Some confusion has arisen concerning the enforcement response
to certain heptachlor/chlordane product* now on the market which are
labeled for use on corn pests. The Administrator concluded in In re
Velsicol  Chemical Corporation, et al. (Expedited Hearing On Heptachlor-
Chlordane;, 41 Fed. Reg. 7552 (february 19, 1976) that

      the benefits of continued use of heptachlor  and chlordane to
      control cutworms on corn crops during the time which may
      be  required to reach a final decision in the cancellation
    .  proceeding are not sufficient to outweigh the human health
      risks identified;  provided,  however that particularly in view
      of the difficult transition require'^ to implement alternative
      cutworm control methods, the use of heptachlor and chlordane
      to control cutworm on corn crops should be permitted during
      the 1976 corn  growing season.  Accordingly, I have concluded
      that the registration for use of heptachlor and chlordane  to
      control cutworms on corn crops should be  suspended effective
      August 1, 1976. _*/

     As you are aware, the Administrator's heptachlor/chlordane orders
provide the following concerning the legal status of the various products:
      */ See also, "Clarification of Order of December 24. 1975, " 41
Fed."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 15Cb)
 (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      . A
 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/heptachib^.on corn, regardless of target pest,
the use of these pesticides to control the white fringed beetle attacking corn
crops in eight southeastern states (AL, FL, GA,  LA. MS* NC,  SC, and TN)
and to control white grubs on corn in Michigan is also precluded.

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 1029-77    AinEX CrlLORDANE BE
 2&o5-l 31   RiiD TCP CHLORDANE 8 SPPvAY
 9859-51    CriLOnDANE 10 GRANULAR
 9850-53    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, aiter December 24, 1975, no product produced after July 29,
 1975 for corn use could be legally distributed  or sold without the above men-
 tioned disclaimer.  The detection of such violative product will continue to
 receive Agency response  in the form of  a FIFRA section I3(a) Stop Sale,  Use
 or Removal Order and section  14 action, as appropriate.  It is the Office of
 Enforcement view that enforcement action,  including SSURO's, should not be
 taken against the sale and distribution after August 1, 1976  of products bearing
 the disclaimer.  The use  of such product on corn after August 1, 1976 is in vio-
 lation of the suspension order [12(a)(2)(J)]( 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?/ r>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 fdr  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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            .-,1"...-.
           *'  .  '>
r
i'^Ni/? -r   ur;'": "^ STATES ENVIRONMENTAL PROTECTION AGENCY
%*."" '",>"                    WASHINGTON. D.C.  20*60
                                                                  OFFICE OF ENFORCEMENT
               To:     Enforcement Division Directors
                       and Pesticide Branch Chiefs

               From:  A. E. Conroy n.  Director
                       Pesticides and Toxic Substances
                          Enforcement Division

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


                  On August 1, 1976, the suspension of existing registrations of
               heptachlor /chlordane products for use on corn was effective as to
               all products formulated-after July 29, 1975.  Thus, the Admini-
               strator's suspension order of December.24, 1975-became completely
               effective as to all subject products formulated after August 29, 1975
               and not already cancelled. The recall of subject products initiated in
               March 1976 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 sustained the
               Administrator's decision  to suspend certain uses of chlordane and
               heptachlor in all but one important respect.  (Environmental Def ens c
               Fund v. EPA, ISo. 76-1247 (D.C.  Cir., decided Nov.  10,  1976)). With"
               respect to the Administrator's decision to allow use of existing stocks,
               the court remanded for reconsideration of such issues as amounts of
               existing stocks and the problems involved in their return  or disposal.
               How the Agency will proceed in meeting the requirements of the
               remand has not been determined.

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                             -2-

    Future surveillance for compliance with the Administrator's
order should be routine cxcc_pt_ in the c.-rsr: of firms refusing to rr.-cill.
Additional visits to producers and/or distributors  may .Se 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 en-t-he level-of jaction'to"berapplieti-at-the	
retail level are leftio 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 ENVIRONMENTAL PROTECTION /-". i;
                                     120CT 1976
      '  ' T '      '  ..      ., '.          *
        Mr. Kalp'i  Ln.-jal   "  ,  '                                '
        executive  Director  \                                  
      '> Chentical Sp.^ciiiltiac r-ianuCACturors    -        ' *
          Asaocicticn;  Incornor&ted
      s- 1001 Connecticut Avenue, ^.'.:.
       . Suite  1120         * ;                -   .
       Washington,  5.  C.  20036          ':    '.       .

        Deer Hr. Unoels                -.                         *

             Vour  latter of  August 30,  197C,  hsc boon referrad.  to
       v this office  icr  re^ly--  Because of. tus  Administrator' f:
        onnoin-3 rvle in  the  ctilc-rdanir/hev'-cnlor proceedinas, it
        would  :2'inoroper unoer the Agency's  rules of practic-a
        for dini to  respond to your inquiry.

         f    Your  letter asks tliat'tha  Adiciniotrotor invokes  tha
        "special Tult"/umier slO(h)(?.), in orcier to allow  invan-
        tcries of chlordane  products  foraiulstod between July  29,. ;
        1^75,  end December 2^, 197T>,  nci  currently on asaler
        shelve;:, to  be eold  until such  f>tochs: ore exhausted.
       .      Vour request would -necessitate' co.iiticiticn  o  the   v
        order isaueu  by the Administrator "on Doceipoer 24-,  1975.
        Rec/U'ists tor  such Modifications  must be r.ioda in confornancc
        with the rules  of practice set forth in 40 CPR Part  164.
        se?j especially  40 CFK Io4.(b),  concerning 'enlarcieit-.cnt oH
       'lilino oeriotisj  40'.CFU 1G4.31, corvcsrninq intervention?
       .anj 40 CTt\ lC/i',110," conccrnir.-y KV cicns for raconsidaration
       "of
  201

SUIHMU
JL

                                                               OFFICIAL. i-ILE COF

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       g
.
      finally,  candor  requires  that I inform you that the
Arjency  statt would  oppose  any  sucu Aotio.i to modify tne* .
suspension  order, snould one in  fact.be  filed.  Essentially,
this  is because  the suspension order is  a tennerary order,
which ultimately will  be sncercoJed Uy en order at the
termination of the  cancellation  nroccaclinq. .The question
of Urn  extent'  to which distriDUti.cn of existing stocks oi
c.hjarafinc j>roi-.:cts  should  be allowed csn and should be
aUrrossed in the cancellation  procoeui'ncj, and resolved in
the order at tha conclusion of that proceeding.  Sound  .
considerations of proceaurcl ntanecjenint  ;nilitate egainst
interruption of  the cancellation proceeding to consider 
this question nt this  time.       *
     * *
'."'  f"    ' .   '   -     - .           '
                        '      Sincere
                                      erely,^

                                      b/&c<
                                  G. Will Urn Frick
                                  General 'Counsel  (A-130)
C,

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/
  CHEMICAL SPfCIALTIES MANUFACTURERS ASSOCIATION. INCORPORATED
   *      cc.o!r. ,n c'.r- SU-.IE nw . icciccxrucTicuiAv^.Nw,wAS)"
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                       -2-
    to.3,600,000  units  remain on the  shelves of some
    75,000  retail dealers.  While  the recall or stop-
    sale  of these units would have an adverse economic
    impact  on many formulators, their normal, generally
    outdoor use would not significantly exacerbate a
    situation that has  been ongoing for sonic 26 years.
    Furthermore,  we have heard that some dealers are/'
  .  simply  flushing unmarketable units away, thereby
    possibly creating a potential  hazard more pro-
    nounced than  that created by accepted uses before
    suspension.   Indeed, safe disposal remains a pro-
    blem  for the  formulator.

3)  There has been some ambiguity  concerning the sale
    of chlordane  that has left a number of formulators
    confused and  uncertain.  On July  29, 1975 you, in
    your Notice of Intent to Suspend, announced that
    you were invoking the Special  Rule for those pro-
   .ducts formulated as of the date of the notice.
  .  We believe that this action should have been, taken
    when the registrations of chlordane for most uses
    was suspended  on December 24,  1975.  Had you is-
    sued an  emergency'suspension order on July 29th,
    the Special Rule could ha"Ve been"  invoked.  By
    letter dated  September 23, 1975,  the Office of
    General Counsel indicated that the sale of pro-
    ducts formulated after July 29th was legal until
  .final suspension decision was made.  On December 24,
   you suspended most  registrations and stated that
   products formulated after July 29th could not be
    sold.   On March 23, 1976 the Enforcement Division
   requested formulators to undertake a voluntary^
   recall of products  formulated after July 29th.
   The net effect of these actions has been to en-
   gender confusion-in many people over the mandatory
   nature of a ban on sales.   While perhaps not de-
   cisive,  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  invoice the Special Rule, it would
alleviate indemnification  problems that will'arj.so with
.respect  to  products  formulated prior to the Suspension
Order.
                *                            *

I look forward  to hearing  from you concerning this impor*
tant matter. -
 RalphX/Gngel
 Executive Director
 RErkas
 cc:  A.E. Conroy

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X
            UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                        WASHINGTON, O.C. 20460
                            APR  | 3
                                               orricc OF
                                        PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM

SUBJECT
Revised Compliance Strategy  for
Suspension of Chlordane  and  Hep
FROM:     John J. Neylan III, Director
          Policy and Grants Division
          Office of Compliance Monitoring

TO:       Addressees
              ion and
             tic ides
     On February 23, 1987, 1n the case of
Against the Misuse of Pesticides vs. EPA.
ruled that the Agency's allowance of the
of aV[ cancelled chlordane and heptachlor
and ordered EPA to take "whatever action
that on and after April 15, 1988, sales,
commercial application of existing stocks
heptachlor which have been the subject of
shall cease..."  Since sale, distribution
chlordane and heptachlor products are air
April 15, 1988, the District Court Decisl
applies to the non-Vels1col chlordane and
which have been voluntarily cancelled.
                                the
                                the
     National Coalition
     U.S. District Court
continued sale and use
 products was void,
is necessary ... so
commercial use, and
 of chlordane and
 voluntary cancellation
  and use of Velsicol's
eady prohibited after
on effectively only
 heptachlor products
     In order to Implement that Court Decision, on April 5, 1988,
EPA issued a "Chlordane/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 11st), and that 1t 1s a violation of the cancellation order
for any person to distribute, sell, offer for sale, hold for sale,
deliver for shipment, receive (and having so received) deliver
or offer to deliver to any person, or to make commercial use or
commercial application of those products after April 14, 1988.

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                               -2-
      In  the  spirit  of the  February 23,  1988 U.S. District
 Court  Order,  on  April 5, 1988, EPA also issued a "Chlordene/
 Heptachlor Termiticides; Notice of Intent to Suspend Registrations
 and  to  Place  Limitations on Sale and Use of Existing Stocks".
 All  of the chlordane/heptachl or termiticides affected by this
 April  5,  1988  Suspension Notice were previously suspended and
 issued Stop  Sale, Use, or  Removal Orders (SSUROs) for failure
 to  respond to  the FIFRA 3(c)(2)(B) Data Call-in.  However, the
 limitations on sale and distribution of the previous suspension
 and  SSUROs only  affected the registrants.  The recent April 5,
 1988 Suspension  Notice includes prohibitions on the sale,
 distribution,  and use of existing stocks of the suspended products
 which are similar to those imposed by the U.S. District Court
 Order and the  resulting Notification of Cancellation described
 above.  That is, after the April  5, 1988 Notice of Intent to
 Suspend becomes  final and  effective, no person may distribute,
 sell, offer for  sale, hold for s  le, deliver for shipment,
 receive (and having so received)  deliver or offer to de"Mver
 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
 hearings, whichever is later.  OCM will inform the Regions when
 the April 5, 1988 chlordane/heptachlor 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/Heptachl or Tertni ticides
 is  identical to the January 29, 1988 strategy in regard to the
 Velsico]  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 termlticides to determine  the first-line distributors
 of those products.   The books  and  records  Inspection  are to  be
 conducted  by States,  or Regions in States  without Cooperative
 Enforcement Agreements, within  60  days of  the date  of  this strategy.
 States conducting  the  books  and records  inspections  are  to transmit
 information  on  the  first-line  distributors  to the Regions where
 Stop Sale,  Use,  or  Removal  Orders  (SSUROs)  are to be  issued  to
 those  persons.   Regions are  to  transmit  information  on first-line
 distributors  located  in other  Regions  to those Regions.   Additionally,
 States and Regions  are  to Issue SSUROs to  distributors,  dealers,
 retailers,  and  users  of suspended  chlordane/heptachlor products
 as  it  is found  during the course of routine  inspections.  Please
 note,  registrants of  the suspended  products  have already  received
 SSUROs in  response  to the previous  FIFRA 3(c)(2)(B) suspension
 action.  Therefore, sale and distribution  of  these  products by
 the  registrant would be  a violation of FIFRA  12(a)(2)(I).  Sale,
 distribution, commercial  use and commercial  application  of cancelled
 chlordane  and heptachlor termlticides 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

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 II
 III
 IV
VI
       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
Louis F. Gitto, Director
Air Management Division

Barbara Metzger, Director
Environmental Services Div
Marvin Rosenstein, Chief
Pesticides & Toxic Substances Br

Ernest Regna, Chief
Pesticides & Toxic Substances Br
Stephen R. Wassersug, Director   Larry Miller, Chief
Hazardous Waste Management Div   Toxic & Pesticides Branch

Winston A. Smith, Director       Richard DuBose, Chief
Air, Pest. & Toxics Mangt. Div   Pesticides & Toxic Substances Br
William H. Sanders III, Dir
Environmental Services Div

William B. Hathaway, Dir
Air, Pesticides & toxic Div
Phyllis Reed, Chief
Pesticides & Toxic Substances Br

Robert Murphy, Acting Chief
Pesticides & Toxic Substances Br
VII   William  A. Spratlin, Director    Leo Alderman, Chief
      Air and Toxics Division

VIII  Irwin L. Dickstein, Director
      Air and Toxics Division

IX    Jeffrey Zelickson, Director
                                 Pesticides & Toxic Substances Br

                                 Alvin Yorke, Chief
                                 Toxic Substances Branch

                                 Davis Bernstein, Chief
      Toxics and Waste Management Div  Pesticides & Toxics  Branch
X     Gary O'Neal, Director
      Air and Toxics Division

cc:   Michael Walker       (LE-134P)
      Jane Hopkins         (TS-788)
      Margaret Rostker     (TS-788)
      Phil Gray            (TS-766C)
                                 Anita Frankel, Chief
                                 Pesticides & Toxic Substances Br

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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  Velslcol Chemical Corporation, the October 1, 1987
 cancellation  of Velsicol's chlordane and heptachlor termiticides,
 the April  5,  1988  "Chlordane/Heptachlor Termiticides; Notification
 of Cancellation and Amendment of Existing Stocks Determination",
 and the April 5, 1988 "Chlordane/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 list 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 list of cancelled products).

 BACKGROUND

     On August 11, 1987, the EPA and Velslcol Chemical Corporation
entered into  a Memorandum of Understanding (MOU) in which Velsicol
agreed to  immediately discontinue the sale and distribution of all
of its termiticide products containing chlordane or heptachlor.
Persons other than Velslcol were not affected by this agreement,  and
were therefore not prohibited from sale, distribution, or use of
existing stocks of Velsicol's termiticides under existing labeling.

    Under the terms of the MOU, EPA also granted Velslcol a
conditional registration for certain uses of  some of Velsicol's
chlordane and heptachlor products.  Velslcol may only  distribute
 these conditionally registered chlordane/heptachlor  pesticide
products as Restricted Use Pesticides if 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  if  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 chlordane/heptachlor  termiticide products which were not
conditionally registered  pursuant to the MOU.  The October 1,  198'
Cancellation Order  was  published  in the Federal R  ri ster on
November 3,  1987 (52  FR 42145).
                                 Under the Cancel  .tion
 Velsicol was  still prohibited from the sale and distribution  of
 its  chlordane/heptachlor termiticides; however, existing stocks
 provisions were established which phased out sale,  distribution,
 and  use of Velsicol's chl ordane/heptachl or termitlddes  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-Velsicol
 chlordane or heptachlor product which has been cancelled (see
 Appendix C for a list of these products).

     Also on April 5, 1988, EPA issued a "Chlordane/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 Votice 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 is, 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 1n the Federal Register,  or
after completion of the suspension hearings, whichever  Is  later.
OCM will  inform the Regions when the April 5,  1988 chlordane/
heptachlor Suspension Notice becomes effective.

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                               -3-
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 chlordane/heptachlor cancellation notice
affects registrants {effectively, only the non-Velsicol registrants
of chlordane and heptachlor termiticides), distributors/dealers/
retailers, and commercial users and commercial applicators  of
cancelled chlordane and heptachlor products (see Appendix C).
The April 5, 1988 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 1s 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 1?F THE AtTGUST 11. 1987 MEMORANDUM OF UNDERSTANDING

     As per the August 11, 1987 NOU, Velsicol may not sell or
distribute any of Its chlordane/heptachlor termiticides after
August 11, 1987.  Products that remain conditionally registered
may only be sold and distributed by Velsicol when the terms of
the conditional registration are met (OCM will Inform the Regions
when this occurs).  Other persons (i.e., distributors/dealers/
retailers, users, and non-Velsicol registrants) were not  affected
by this agreement.

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                           Ri-yister / Vo!  52  No  2",2  ' Tunsd.iv.  N'ow-.'.pr 3. 196?  /  Notir.rs
ii; c;r
-re cJ
          '   s: jjl b< nntjc v%iih
         -:..  < !(..i:-. 5H p S ;  u! the
           ".; i rt,j"Sf- spray nozzle
         > :.!,. -.?-. nj horizontal b.irni'is
         -( v sld-^s cannot be poured
         / ; IM- ..irr.e J^y ii has been
         : ,i \\utrr-proof cover, such as
         .;icnt' shec-ung.  should be
         0-. t-r  the soil to prevent
  r-ci.rn Tn  ^ is not necessary if
  fi.uTd.iticn wails have  been insuiied
  ..rr.jnd Ihe treated sc.il.

Vi-r'.jc .ii Barriers
  Afi.-r ihp fo'jrri.it.on wn!!s Have been
pujrrj cr buiii but before slabs are
poured, vertical barriers may be
es' iM.ihrd ir.  so;! which will be under
ihe perimeters of floating or supported
sij.i? around utilities which will
PF-:-.L ':):: the slab and in other crMit^l
,ir. ,:s '.-.rich w.JI be covered  by
r . r.' T'.-.r After the final exterior grading
iv i^rrpte:cd. vertical barriers may be
crtuifd in back-fi)!?d soil against
foundation wails or against the outside
of ncnulith.c slab. To produce a vortical
harper applv  !he emdiion at the rd'e of
4 Ccli.-r.s per linear fret per foot of depth
{nr-. cMtk- to the top of the foorir.s For
-'  :. i:!hir s; i:-;  apply to :he bottom of
 I ,-vv prrssurr rr
                   .ric
         -. .i;ji!:rat!-jr.s should nc' be
      .< b-, 'L>W rhe lop of ;hc fcc:;r.j;
     c^r' Khrn the footing ;s e\pos?d j:
  or ul:".r c'aiJe. Speci^.! care shct'J
  tr tdktn 10 avoid soil washout around
  ;S  fn&nrij
When reeding, use cn!y lew presyu.'e
  (less t.hdr. C5 p s i. ai the nozzit)  1; is
  iiriporiant that emulsion reaches the
  foctir.p  Rod holes should be spaced to
  prcvide a continuous barner.
 Trenches need not be wider ihdn G
  inchas.
 E^yision 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.-c:>/' Space Foundations
  For craw] space foundations, vertical
barriers ma> 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 redding and/or trenching
to the footing.  If the footing is exposed
at or above grade, application should be
nude with specid! care to avoid w;ih-
O':i around the footing
 Do not trciit the footing thru ugh
  hollow masonry voids.
 Rod h lie-. sK uld L.1 'Ourui to prir.itir
  .1 coniin-jous tKnir,i| barrirr
V.'hpn r't!J:r.z i.kf ..iririj. pi---ru:ii-r.
  u^r low jin 
-------
Vn!  3;
                                                                     \,
 5  C v prv*.,';r'  rodtlmg Jiui/or irrnthir,;
 .ii ih< r jn- uf 4 g.illons of emulsion pt>r
 in nni .1: frft Low press,if rmldir.y
  :;o-_!J ni;' cicnd beyond *h Inf. uf

  V. i.pn lodJing. use on!> low pressure
   {Irss ;har) 25 p si at the nicziu)-
 U,-,.J h be applied only
 by t;c r.chir.R or the exravation
 te,hr.:quc below ct a r*'.e of 4 gallons of
 rrru'sion per 10 hntvr feel per foot of
 depth to be treated. Where exterior
 s..i!is arc adjacent to the  foundation
 wall, drill throuph the sUb along the
 outside of the wdil at a spacing  that
 provides application of a continuous
 b.i.-r-i-r and apply the emulsion just
 i:rdpr the slab. After drilling, emulsion
 may be applied. Apply only at the
 lowest pressure that will  start the flow
 of emulsion from en  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
 fooling, and to other interior critical
 areas.

 E\cavation Technique
  If treatment la to be made in difficult
 situations such  near well* or citterns,
 along faulty foundation walls, and
around pipes and utility lines which lead
 downward front tha atructure.
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 rate of 4 gallons
  of emulsion per 10 linear feet  per foot
   r.f !i-;i:h .if I1'- tn-n*';  Mm t!ic
   C'!'uUi"is n'w.ujHy rrr'i \h\. -.n-l
   l.i* :,. i .ire !. ; -i n.Til li^t.tj .'i.un
   nir::-..:-^ ^ff I:  lir.i r
   Aficr i*u src.ittd so;: lus urud
   .idv^ii.iir'x. ri-;'Lrr  lit .ml .n il.f
   trtT.i. h and tover wi:h .ipi.'rt>Mr'i,.ii.ity
   2 :ncr>r$ of uniruatcri soil
net. i*:i.:
S.-r^ i

ofV.Vi'i
Pruti-i.:
 OIT
' ' -> r
; , .111 U-
(.... !*:<
as; A^f
1 ni-


n-t^r
HI \
 - - wi .  i
. \i : " >' '
.1^" . .. ,* i ' .i/
,r t|>>"-v ^
,, r...,,.-.'fl
4u: N:S.. . '^
   Retreatmcnt for subterranean lerrr.iics
 should onlv  be made when there is
 (nidenci- of reir.festation subsequent to
 the initial treatment, or thcrf has been
 disruption of the chemical barrier in the
 soil due to construction, excavation.
 liir.dscapmg. etc. Kctreatment shojld be
 rrade as a spot appiicntion tc these
 areas.
   Resentments may be made to critical
 ureas m 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 bo obtained from the
 person listed under FOR HOME
 INFORMATION CONTACT:
   Daitfd October :i ISfCr.
 Dou(la D Carrpl.
 Director. Orf.Cf otf-?s:iCitJrPiv$ivm:.
 |FR Doc 8r-!3J83 Fiicd ll-2-6r. 6 45 nmj
 ILUNC COOC J4--U


 IOPP-1B0747; FRL-32S6-5I

 California Department of Food and
 Agriculture; Receipt of Application for
 Emergency Exemption To Us*
 Hydrogen Cyanamlde; SollelUtion of
 Public Comment

 AGINCY: 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") lo use the active ingredient
 hydrogen cyanemide ("Dormex") to
 promote uniform bud break in 16.800
 acres of table grapes grown in the
 Coachella Valley in Riverside County.
 California. Dormex contains an
 unregistered active ingredient and.
  therefore, in acordance with 40 CFR
 166.24. EPA is soliciting comment before
 making '-e decision whether or not lo
 grant Uu  exemption.
  OATt: Comments must be received on or
  before November 10. 198".
 AOONCSSES: Three copies of written
 comments,  bearing the identification
\\.ishiiv.-..i. JVC :u
  In pt:ion. bring commtr.ti u. R:n I>u
Crssl.il Mall *2. 1921 Jefferson D.i\is
Highway. Arlington. VA.
  lnforni.it ion submit led in  .ir,\
commpr.t roncerninp this nonce n:.iy te '
rlaimed cnr.fiderttial hy marking jny
part or all of that informal.on  as
"Confidential Business InformJMC^
(CBI)." Information so marked wui ro(
be disclosed except in .icccrdjncc v.;'h
procedures set  forth m 40 CFR Port z. A
copy of the comment th.it docs ccr.tjm
GDI mus! be submtsted for -icLsiOr.  .r.
the public record. Information nut
marked confidential may be disriusci!
pubiicK by EPA wilhou! prior notice HJ
the subrr.itter. All written comments w::l
be available for inspection  in Rm. 230 <*:
the address given above from S a.m  to 4
p.m.. Monday through Friday, excluding
legal hohdays.
FOR FURTHER INFORMATION CONTACT:
By mail; b'.'by  Pemberton. Rig:stration
Division (TS-rerC). Office of Pesticide
Programs. Environmental Pro!cct;cr.
Agency. 401 M Street. SW.. Wasrunp-.o.-..
DC 20460
  Office location end telephone i
Rm. 716. Crystal Mo!! =2 19:: ||
Davis Highway. Arlington.  VA.
557-1606}
SUPPLEMENTARY INFORMATION: P'jr.ruar.t
to section 16 of the Federal Insrr.iir. Je.
Fungicide, and Rodenticide 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 condition?
exist which require such exerrpticr..
   The Applicant has requested the
Administrator  to issue a specific
exemption to permit the use of an
unregistered plant regulator,  hyijrogcn
cyanamide (CAS 420-04-2).
manufactured as Dormex. by SK'.V
Trostberg Aktiengesellschaft. to promote
uniform bud-break in table grapes
grown in the Coachella Valley m
 Riverside County. California.
Information in accordance with 40 CFR
Part 166 was submitted as  part of this
 request.
   Approximately 18.800 acres of labic
 grupes. Vitis spp.. are grown m the
 Coachella Valley. The Applicant
 indicates thut California growers rf
 early market table gnpes arc frir-.ra
 economic losses due to increas:rc
 competition from fore:?- impcris.
 particularly from Mcvco. The Ar

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                              -4-
 REQUIREMENTS OF  THE OCTOBER 1. 1987 CANCELLATION ORDER
      The  registrations of Gold Crest Termide, Gold Crest  C100,
 and  Chlordane SEC  Termite were amended by splitting each  registrati
 into  two  separate  registrations.  A new EPA registration  number
 was  assigned for each of the above End Use products for the uses
             Appendix A as "retained uses".  The remaining uses
                above products maintained their current EPA
                                                                  on
     two
    i s s i <,
described  in
for each of the
registration numbers of 876-233, 876-63, and 876-104 respectively.
      The  regi
and  Chi ordane
EPA  registrat
been  vo1untar
wi th  the  fo11
Gold  Crest  H-
spray  (Termid
perimeter spr
space  perimet
order  also  af
(the  list of
             strations  of  Gold  Crest  Termide, Gold Crest C100,
              SEC  Termite,  which  have  maintained their current
             ion  numbers  of 876-233,  876-63, and 876-104 have
             ily  cancelled  effective  September 30, 1987 along
             owing Velsicol  products:  Gold  Crest C-50 (876-86),
             60 (876-85),  California  SLN  for crawlspace perimeter
             e) (CA-810012),  California SLN for crawlspace
             ay (C-100)  (CA-810012),  and  Hawaii SLN  for crawl-
             er spray  (C-100)  (HI-850003).  The cancellation
             fects Velsicol 's  supplementally distributed products
             supplemental  registrations are in Appendix B).
     The Gold Crest Termide, Sold 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 MOD, are met.  Additionally, the cancellation
does not affect the following Velsicol chlordane and heptachlor
products:  Technical Chlordane/ Export (876-280); Technical
Neptachlor/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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r
                               -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.
                                  chlordane/heptachlor suspensions did  not
                                  the sale or use of existing  stocks of
                                  persons other than the registrant.  Any
                                  from the April 5, 1988 Notice of  Intent to
                                 prohibitions on the sale and use of existing
However, the previous
place prohibitions of
suspended products by
suspensions resulting
Suspend will Include
stocks of suspended chlordane and heptachlor termi ticides.


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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 maydistribute,
 sell,  offer for  sale, hold for sale, deliver for shipment, or
 receive (and having  so  received) deliver or offer to deliver to
 any  person,  or to make  commercial use or commercial application,
 suspended chlordane  and heptachlor termiticides.

 COMPLIANCE  MONITORING

      Conformance with the August 11, 1987 MOU will be determined
 through  inspections  of  Velsicol's establishments to determine
 whether any  stocks of chlordane or heptachlor were sold or
 distributed after August 11, 1987.  Please note, there is no
 violation under FIFRA for not conforming with the terms of an
 MOU,  however,  the Agency would like assurance that the terms of
 the MOU  have been met.

      Compliance with the October 1, 1987 Cancellation Order
 and the  April  5, 1988 Notice of Cancellation and Notice of
 Intent  to  Suspend will  be determined through inspections of
 producing  establishments, distributors/dealers/retailers, and
 users  of  chlordane and  heptachlor termiticides.  Noncompliance
 with  the  October 1,  1987 Cancellation Order or the April 5, 1988
 Notice  of Cancellation  1s a violation of FIFRA sections 12(a)(l)(A)
 and 12(a)(2HK).

     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 di stn'bu tors/deal ers/retail ers,  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.
      Regi ons/States wil1
 as appropriate.
also investigate all  tips and  complaints,
      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 S12(a)(2)(I)
 Sale,  distribution, commercial  use and  con.mercial  application of
 cancelled chlordane and heptachlor termiticides is  a  violation
 of FIFRA $12(a)(2)(K).

 Registrant/Producer Level	

      By  April  29,  1988, the Agency/States will  schedule  and
 conduct  inspections of  Velsicol's establishments to obtain
 assurance that Velslcol has complied with the October 1, 1987
 Cancellation  Order  by not  having released products  for shipment
 after October 1, 1987.   At this Inspection the  Agency/States
 will  also obtain assurance that Velsicol  has abided by the
 terms  of the  August 11, 1987 MOU by  not having  released  the
 affected products  for shipment after August 11, 1987.

      Within 60 days of  the date of this strategy,  the Agency/
 States will conduct a books and records Inspection  of the non-
 Velsicol chlordane/heptachlor registrants to determine the first-
 line  distributors  of those products.

      During the course  of  routine inspections,  the Agency/States
 will  obtain assurance that non-Velsicol registrants/producers
 have  not sold or distributed their chlordane/heptachlor products
|in violation  of the cancellation orders,  suspension orders, or
'SSUROs.

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                               -8-
 D Is  r 1 b u t o r / D e a 1 e r / R e t a 11 L e v e 1

     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 termiffcide
 proc  :ts are being sold  and distributed in accordance with  the
 Octooer 1, 1987 Cancellation Order.

     After April 15, 1988, when Agency/States conduct routine
 inspections at the distributor/dealer/retail  level, they will
 assure that remaining stocks of cancelled chlordane and heptachlor
 termitic ides are not being sold.

     After the effective date of the suspension order, the  Agency/
 States will conduct routine inspections at the distributor/dealer/
 re*ailer level to assure that remaining stocks of suspended chlordane
 ana heptachlor termiticides have not been moved and are not being
 sold.

 User Level
     During routine use Inspections prior to April 15, 1988,
inspectors will assure that 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
user level, Agency/States will assure that any remaining
of Velsicol chlordane and heptachlor are not being used,
remaining stocks of non-Velsicol cancelled chlordane and
products are not being used for purposes of commercial use or
commercial application.
the
stocks
and
heptachlor
     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 applica* on.
ALLOCATION OP KtSPONSTBTLTTlES
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 chlordan?  nd
  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.

-------
                                        -9-
          Office of Compliance Monitoring
          0 Will develop and transmit the Compliance Monitoring  Strategy
            to the Regions.

          0 Will issue SSUROs for non-Velsicol  chlordane/heptachlor
            termiticides suspended under FIFRA  3(c)(2)(B).

          0 Will transmit to the Regions the list of those  products
            which have been cancelled pursuant  to the October  1,  1987
            Cancellation Order,  cancelled as specified in the  April  5,
            1988 notification, or suspended pursuant to the April  5,
            1988 Notice of Intent to Suspend.

          8 Will transmit a list of establishments  producing Velsicol's
            chlordane and heptachlor termiticides to the Regions.

          e Will notify the Regions if and when Velsicol has met the  terms
            of the conditional registrations of Gold Crest  Termite,  Gold
            Crest C100, and Chlordane SEC Termite,  and therefore when  these
            products may be sold and distributed.

          0 Will notify Regions  of the effective date of the April  5,  1988
            Notice of Intent to  Suspend Chlordane and Heptachlor Termiticides.

          Regions	

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

          * 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.

          e 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 Hill 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-cor*ormance  with the
  terms of the MOU by Velsicol.  As stipulated  in the January  29,
  1988 Chiordane/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.

 * 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.
  Will conduct a books and records
  chlordane/heptachlor registrants
  distributors of those products.
inspection of non-Velsicol
to determine the first-line
0 Upon identification from the books and records inspections,
  States will transmit information on the identity of first-line
  distributors to the Regions.

e Will take enforcement action, Including Issuing SSUROs, as
  appropriate, provided they have the authority.

e 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 1s due April 7, 1988.

-------
Establishments  Producing  Velsicol's  Chlordane  and
             Heptachlor  Termi t i ci des
                   00876-11-001
          Velsicol  Chemical  Corporation
              Box  39A  II 1 i noi s HWY  1
                Marshal 1 ,  IL  62441
                   00876-TN-001
          Velsicol  Chemical  Corporation
               1199 Warford  Street
               Memphis, TN  38108

-------

-------
                APPENDIX  A

       Retained  and  Deleted  uses  of
 Velsicol's C il oMa ie 'Hept ach 1 or  Products
Velsicol classified the following uses of

its end-use termiticiae products as

"deleted uses":

  a.   post-construction application of
       material *rotn 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 redding 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
g
       applicators;

       soil-injection pressure rodding at
       pressures greater than 25 psi.
     The agreement further classified the

following uses of end-use termiticide

products as "retained uses":

  *.   application to the outside
       perimeter of any structure by
       trenching, or drilling .through
       sidewalks, patios, gr <5ther
       unenclosed slabs, and applying
       material to the soil without
       pressure (e.g., flow or gravity
       feed);

-------
d.
                  -2-

               APPENDIX A
  b.   applications by cne excavation
       technique co the exterior of any
       structure (i.e. , by removing soil
       next to the foundation, placing
       on a tarp, treating with
       terraiticide. and placing back in
       trench after soil dries);

  c.   pre-construct ion low-pressure
       (maximum 15 psi) vertical rodding
       (with the application rod equipped
       with a pressure control device to
       prevent higher pressures) of the
       perimeter outside any structure;
       pose-construction low-pressure
       (maximum 25 psi) vertical rodding
       (with the application rod equipped
       with a pressure control device to
       prevent higher pressures) outside
       slab ana 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 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 Veisicol's termiticide products.

the agreement included, inter' alia, the

rollowing provisions:

0  The retained uses were converted to
   restricted uses as provided  tor in
   Sections 3(d) and 4 of FIFRA;

-------
                                    A?=ENDIX
                            The registrations of Che 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 net.

                            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 noc 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
                            temiticide.
,11

-------

-------
                           APPENDIX B

              Supplenental Registrants of Velsicol's
               Chlordane ,'Heptacnlor Termiticides
 (d?S-C3053-000192)

 (875-00053-000430)
 (376-
 (376.
 (376-
 (376-
 (375-
 (376-
 (376-
 (876-
 (876-
 (376-
 (876-
 (876-
00063
00063
00063
00063-
00063
00063-
00035
00086
00086-
00086
00036-
00086-
002935}
005887)
-010370)
025030)
-034704)
043227)
035034)
000016)
000192)
004876)
005887)
00.387)
(376-00036-005887)

(876-00086-006723)
(876-00086-010370)
(376-00036-012000)
(375-00036-012000)

(375-00036-034704)
(376-00100-OU0192)
(876-00104-000430)
(376-00104-001812)

(376-UQ104-004876)
(876-00104-006723)
(376-00104-025030)
(876-00104-042761)
(376-00233-001927)
(876-00233-006754)
Drexol Chlordane 72* Termite Spray for
Professional  Termite Use
Durham's Cnlordane Emulsifiaole 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
Di versey 2.5  H
Dragon 451 Chlordane Spray
Dexol Chlordane 45X Termite Spray (Prof./Termite  Use
AG Chlordane  4-EC Termite Control
Black Leaf 451 Chlordane Termite Killer
                         Termite Killer For  Use

                         Emulsifiable Consentrate
                                                   for  Use  Around
Black Leaf 451 Chlordane
Around Buildings
Black Leaf 451 Chlordane
Insect icide
Red Wing Chlordane 4 EC
Ford ' s Chiordane 4 EC
K Mart 45X Chlordane Termite Killer
K Mart 451 Chlordane Termite Killer
Bu i1d^ ngs
Pro-Chlordane 4-E
Dexol Chlordane Termite Spray
Durham's Chlordane SEC Emulsifiable Concentrate
Pee Gee 8 IDs. per gallon Chlordane Emulsifiable
Concentrate
Chlordane-8 Termite Control
Red Wing Chlordane SEC
Red Panther Chlordane
Red Panther Chlordane SEC
Terminix C-H
Orkil 2X

-------

-------
G,
 C.
                    FIB* I:.     \    '
                    01/Ci/H          :
                            st;? SAL'S ISJTK AS :
                                     of Products Containing
                                    rdane  and Heptachlor
                    COWAM
                    WVA:  CEMICAL COEP.
                    41C3 MS: WSSIIISTCI  BLVD
                    105 A$::IES    H 90023
                    AVAC c-*::iL ccs?.
                    4100 !S:  MieHr/H EX
                    LOS 4S'!L!S    C. 50:23

                    MT;AC CRMCJIL COB?.
                    41 :c EAST  KASiisros BT.V:
                    MS ASGiLES    CA W.I}
                     IK; KST iAS-isr'jii :vr-
                     LOS AS;L!S   CA 90I2i
                     Ai CH::*: *3E?,
                     iSH ELEVtSTt ST
                     NZTSWtti     OE 45662

                     AP CE-V.CA: ::=?.
                     15:4 EL!V!!lrf ST
                     ?'-TS.;:::     OE  45e<;

                     A= CH*::A: co-j.
                     'li< i,".5Vt8r: 57
                     JCETS;:7E     CH  456*2

                     B 4 G  KMt
                     1D539  A5A!C!'. M  B5H  iC'<
                     DALLAS        ?!  1522C
                     8LAC?  L!A? PSODrCTS CO.
                     67 I  STATE ST
                                   II 6C12:
EUCI  l!F PRODUCTS CO.
fca7 I  STHE ST
ELGIN          II 60:20

80SCIE CBEHICAl CO., 1.
2 KUSl AVE.
MEJV.L1!      SK 13495

80SDI! CH-SIC4L CO., ISC.
i KZ AVE.
KCP.rviUE      I! 11*^5

E0i:! CH*!CAL CO., ISC.
2 n:s; AVE.
10-FVi;:!      UK !J45
                            5*b:  223
                            545.  226
                            5481  31
                                                 5461  50
                            7122  121
                            V ^  1
                            /** A
                                       CSLC2DARE
                                       CHLOS:ASS
                                       CSIOBDAH
                             .->;;
                             SiS"   127
                                                   i:  6?
                                                  4     274
                                                  4     21?
                                        CEWF.DASE
                                                             CHLOSDASE
                                                             CSiLOSIAS:
ss iss:-: L!?::A:- H:::" "*


Ol/Jfc/BB    /  /  OS     CA
                                                                                 01/C6/I8    /
                                                                                                                               CA
                                                                                  01/06/88    /  /   05     CA
                                                                                  01/06/88    /   /   09     Ci
                                                                                                       01/fl6/86    /  /    C5     OH
                                                                                  51/06'$$    /  t  ' K     OE
                                                                                                    !6     TI
                                                                                                        01/06/88    ,'   /   r:5     IL
                                                                                                        01/03/8B       '    i.;     I!
                                                                                                        01/06/86    /  /    C2

-------

-------
                           APPENDIX B

             Supplemental Registrants of Velsicol's
               Chlordane/Heptachlor Termiticides
(876-00053-000192)

(876-00063-000430)
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
00063
00063
00063
00063
00063
00063
00085
00086
00086
00086
00086
00086
002935}
005887)
 010370)
-025030)
034704)
043227)
-035034)
-000016)
000192)
-004876
005887)
-005887)
(876-00086-005887)

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

(876-00086-034704)
(876-00100-000192)
(876-00104-000430)
(876-00104-001812)
(876-00104-004876)
(876-00104-006723)
(876-00104-025030)
(876-00104-042761)
(876-00233-001927
(876-00233-006754
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
Oexol Chlordane 45% Termite Spray (Prof./Termite Use)
AG Chlordane 4-EC Termite Control
Black Leaf 45% Chlordane Termite Killer
Black Leaf 45% Chlordane Termite Killer For Use
Around Bui 1 di ngs
Black Leaf 45% Chlordane Emulsifiable Consentrate
I nsecti ci de
Red Wing Chlordane 4 EC
Ford ' s Chlordane 4 EC
K  Mart 45% Chlordane Termite Killer
K  Mart 45% Chlordane Termite Killer
Bu i 1 di ngs
Pro-Chlordane 4-E
Dexol Chlordane Termite Spray
                                                   for Use Around
               Durham's Chiordane
               Pee Gee 8 Ibs.  per
               Concentrate
               Chlordane-8 Termite Control
               Red Wing Chlordane SEC
               Red Panther Chlordane
               Red Panther Chlordane SEC
               Terminix C-H
               Orkil  2X
                             8EC  Emulsi fi able
                             gallon  Chlordane
                                    Concentrat e
                                    Emulsifiable

-------

-------
 COMPEJT?

 Bonide Chemical
Dragon  Che-deal
Corporation
Rico Company
Incorporated

Thompson-Hayvard
Chemical Company
      APPENDIX C
 CHLORDANE CANCELLATIONS

EPA REGISTRATION NO.

     4-96
     4-218
     4-274
     4-275
     4-287
     16-96
     16-116
     16-122
     16-124
    70-119
    148-27
EFFECTTVF 1

3/17/88
3/17/88
3/17/88
3/17/88
3/17/88
                                                   4/27/87
                                                   4/27/87
                                                   4/27/87
                                                   4/27/87
                             4/27/87
                                                  6/01/8'

-------

-------
 Litxt. 1  Industries
 Tobacco  Stages  Chemical
 Company


 Chevron  Chemical
 Cor.pany


 FMC  Corporation


 C.J. Martin  Conpany

 Residex  Corporation
191-42
192-43
192-132
192-133
226-177
226-184
239-478
239-1232

279-383
279-538

299-171

373-26
                                                  3/20  8S
                                                  3 / 3 0 / 8 S
                                                  3/30/88
4/27/87
4/27/S7
3/25/87
3/25/87

3/07/87
11/01/86

3/25/87

3/25/87
  .poritl  Incorporated
Boy1e-Mi dvay  Inc.

Rockland Cheinical
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

-------

-------
 -o
 MFA Ci 1 Cor.par.y


__ Security Lawn and
""" Garden Products Co.

Faesy i Besthcff
Incorporated
1 Chas. H. Lilly Co.
Green Light Ccmpany

Velsicol Chemical Co.












Miller Cherr.icai &
Fertilizer Corporation

Cre-0-Tox Chemical
Products Company


Seacoast Labortories
Incorporated
Cotton States Chemical
Company
Land 0' Lakes


746-53
746-76
746-119

769-90
769-511

779-82
802-71
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 15 ':
3 25  '
3 1 5 ,.  7

3/25/87
3/25/87 .

6/OZ/87
9, 11/ET
3/25/87
3/25/87
11/04/87
.-,,'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
3/19/86

7/01/87
7/01/87

8/20/87
8/20/87
3/25/87
3/25/87
Universal Cooperatives
Incorporated
1386-26
3/25/8"

-------

-------
 Or.--, tiebach Chemical
 Co: porat ior.
 FCX,  Incorporated
 Griffin Corporation
 Tria:.gle Chemical
 Teririnix Division
 cf  Ccok Industries
 Incorporated
 r.LCO  "ar.uf act'-ring Co

 Farmland Industries
 Incorporated
r.-:.R.  Grace & Coir.pajiy

PSI-C-ordon
Corporation
Hopkins Agricultural
Chemical

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

Stephenson Chemical
Company Incorporate
 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
     8, 2J - o~

     3/21 S3
     4/27/37
     4/27/87

     7/01/87
     7/0 i .'87
                          I< / ~ 4 ,  /
                          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

-------

-------
        Cherr.ical
Incorporated
Coastal Chemical
Corporation

Chacon Chemical
Corporation

GRO Chemical
C crip any

Helena Cher.icai
Coir.pany
Octagon Process
Incorported

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

Sunniland Corporation

Nationwide Chemical
Products, Inc.


Ross-Daniels, Inc.

Cornbelt Chemical
Company
4931-5
4 9 1 - 6
5549-41
5719-2-
5778-33
5905-97
5905-102
6830-15

7122-3
7122-34
7122-121
7234-5
7234-6
7234-10
7234-100
7234-101
723-1-20
7401-78
7401-348

8612-86

9404-6
9591-6
9591-7

9649-2
10107-7
10107-8
6/29, 8"
6/29/3'
3, 17/88


7 / 01 / S 7


6/11/87
3/25/87
3/25/87
7/01/87

3/17/88
3/17/38
3/17/88
3/17/83
3/17/88
3/18/88
3/17/E8
3/17/88
3/18/88
6/18/87
6/18/87

3/21/88

3/23/88
10/01/87
10/01/87

6/12/87
3/21/88
3/21/8E

-------
 ? ::" d ' s  C; ic * i r a 1 c.
Hr.cier.aa  Enterprises

rur.a  Chemical  Company

Lrexel  Chemical Ccr.par.y
?:atte  Chenzcal
Ccr.pany

Falls Chemical
Raw Valley,  ir.c.


V.'ilscr.  Lairoratories


Car.ercr. H.  Bairc

r-'icro-Flo  company
Garden Care by
Farmingdale, Ltd.
10370-4C
10370-116
10370-144
10370-145

11037-7

11611-4

19713-214
19713-215


34704-1
COMPANY

TIiompson-Hayvard
Chemical Co.

velsicol Chemical
Corporation
EPA REGISTRATION NO.
148-964
876-101
876-85
876-233
876-308
876-309
876-310
                         3,2S- 8S
                         3.- 2 b i c
                         3/2S, 63
                         3/ 28, 63

                         4/27/87

                         7/17/87

                         3/24, SS
                         3/24/33


                         4/27/87
40831-5
40631-24
. 44215-7
44215-20
50383-20
50383-29
50415-27
51036-30
51036-31
53127-1
53127-10
HEPrfyCHLQR CANC.FJ-T.I
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
^TIONS
                    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-Q-Tox Chemical
Products Company
Griffin Corporation

7r i angle Che-ical Cc .

r&rr.inix Divisicri of
Cock Industries, Inc.

Stepi-.enson Cher.ical
Ccr.pany Incorporate


Roiv.-ood CnciTiical, Inc.

Pe v;ing Chenical

                       *
.".rvher; Corpcraticr.

Forshaw cne-dcal Company
1066-28
1066-29
1066-30

1812-77

1342-183


1927-50
4887-59
43S7-85

4981-17
Cnerri-Nut , Inc .

Farmco Industries
Incorporated

Micro-Flo Company
37686-27


46778-1

51036-50
7/01/87
3,19/88
7/01/87

7/01/37

5/14/8"


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

 7/08/63
6723-8
7122-6
7234-27
7234-31
7234-89
6/07/84
3/17/68
3/18/88
3/18/88
3/18/88
5/08/87


5/12/87

4/27/87

-------

-------
                         APPEND:/:  D
                                   S rs
COMPAJfY

Var. Writers  &  Rogers,  Inc.
Chap-an Cheir.ical
Company
                              550-106
                              550-107
                              1022-502
Vaccine! Chemical Company
Incorported                   1353-4

AMVAC Chemical Corporation    5481-223
                              54B1-226
                              5481-50
                              5481-315
                                                  7/18/67
                                                  7/18/87
                                                   7/15/87
                                                  7/15/B7

                                                  7/17/87
                                                  7/17/87
                                                  7/17/87
                                                  7/17/87
Carolina Chemical
Corporation

Black Leaf Products
Ccr.par.y
Sr--jthcrr. Mill Cree):
Fro^jcts Cor.par.y
Dettle;ach Pesticide
Corporation
Mystic Cher.ical Products
                              5797-8B
                              5857-67
                              5687-127
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
                                                  7/16/87

                                                  10/21/87
                                                  7/15/87
                                                  7/15/67
                                                  7/15/87
                                                  7/15/87
                                                  7/15/87
                                                  7/15/87
                                                  7/15/87
                                                  7/15/S7
                                                  7/15/87
                                                  7/15/87
                                                  7/15/87

                                                  7/15/87
COMPANY

Southerr. Mi 11 Creek
Prcfucts Cor.pa.iy
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                  Federal Reuister  /  Vol. 52.  No. 212  / TursilrfV. Novrrnl>or 3. 1lH*
                                                                       42141
t
h'M fust Uraft of the Kik
Kir.ii.uiion Croup s sl rali:u\ on
i-nvii.:an;< n:.il risk reduction
  Thi mi-ciing is open  to the public. Any
men,her of lh* public wishing to attend.
rv.jke brief or.il comments, or submit
written comments to the Croup should
notify Mrs Kathleen Conv/ay. Executive
Setrot.iry. or Mrs. Dorothy Clark.  Staff
Scoffidry. (A101-F) Sciencr Advisnry
Daard. by the close of business on
Friday. November 20.1987. The
telephone number is {202} 382-2552
Terry F. Yocie.
Dirc-.'.or. Snera Advisor}- Board
  U-.lc  Oc:ol-Lf TS 19.""
JFR Doc. 87-:5383 Filed ll-:-e.*; 8 45 urn]
IUJMC cooc
Science Advisory Board Research
Strategy Subcommittee Sources,
Transport and Fate Group; Open
Meeting

  Under Pub. L B2-463. notice is hereby
given that the Sources. Transport and
Koic Subgroup  of the Science Advisory
Bo.ird's Research Strategies
Subcommittee wif) met I from 9:00 a.m
to 4 00 p.m. on December 81h at the
Hyati 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 to acquire scientific
and technical information to support
regulatory decision making, and to
identify emerging environmental issues.
The Sources. Transport and Fate
Subgroup will evaluate  environmental
contaminants from both a media-
specific and a multi-media basis.
  The meeting it open to the public. Any
member of the public wishing to attend
or submit written comments should
notify Dr. Terry F. Yosie, Director.
Science Advisory Board, at 202-382-
4126 or Joanna Foellmcr by December 4.
1907,
  Date October 2fl. 1087.
Terry F.Voi IB.
Director. Science Advisory Board,
|FR Doc. 87-25391 Filed 11-2-67; 8:45 m|
ILL1NO COM MW-M-N
IOPP-*0011;FRL-3JB6-SI

Chlordane and Heptachlor
Termiticides; Cancellation Order

AGENCY: tnvironir.cnl.il I'jo'-clion
Agency (LI'A)
ACTION: Order.
SUMMARY: On October 1.1987. El'A
issued an Order accepting the voluntary
cancellation of certain chlordane and
hcptachlor lermiticide registrations held
by Velsicol Chemical Corporation, and
hmilinf: the use of existing slocks of
Velsicol's chlordane and heptachlor
termiticide products oulside the
company's control on August 11.15*87.
Under the terms of (he Order, such
stocks may be sold, distributed or used
according to their current labels until
November 30.198". From December 1.
19E7 until April 15.1988, such stocks
may only 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 IS. 1988.
FOR FVRTMEft INFORMATION  CONTACT
By mail: George LaRocr.a. Registration
  Division (TS-767C). Office of Pesticide
  Programs. Environmental Protection
  Agency. 401 M Street SW..
  Washington. DC 20480
Office location and telephone number:
  Rm 204. Crystal Mail Building *2.
  1921 Jefferson Davis Highway.
  Arlington. VA. (703) 557-2400.
SUPPLEMENTARY INFORMATION: On
August  11,1967, EPA and ''elsicol
Chemical Corporation (Velsicol) entered
into an  agreement affecting Vetsicol'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 convertad 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
11 Ih agreement did not affect existing
stocks of Velstcot's termiticide products
outside of Velsicol's control on or faelore
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 io a federal court
action.
  Tit.- (."irt iti !im< ,i. linn r\|ir ->-i .!
i.mil Tr ih il t.i' \ ;- :^n| n.n r
<:Mi'fL'iti'r..!i-r! Mir .11;; v.iiv t ! rv >  ;:.:
sUie.ks in llut >!> if :i'i i \iSi.fk; .:>. .
niiph! rxTtdnui- t:.Ji insitrJy VVhi.r \'.\'\
ninlinjr-s ly bfi.i:vc Ti-it US rs!:n-, i'c
v..is nn jLcur.itL- one. Li'A nr.J \ i-isicoi
.lyetil lo suppli-ment  Ihe Auirust 11 sh
av;i rcniur! in orciur lo  Hlii-vi.iie tht-
court's coru cms.
  Under the terrr.s of the S^pplnmcr.!.
i.itififd on OcUfier 1.  lytr. Vebicol s
chlr.rrlnne ar.d heptnchlor tcrrniticidi:
rcpistriiticns worn split ir.tn produr?
ri'^istrdiionb cor.tjiring the dcSeied uses
ard product registrations containing the
retained uses. Those registrations
containing the deleted uses were
voluntarily canceled  EPA issuer! .in
Order on October 1.1957. accepting thu
voluntary cancellation and placing j
two-licred cap on the  use of existing
stocks of Velsicol's chlordane and
heptachlor termiticide products outside
of Velsico! s control on August 11.190".
These stocks may be sold, distributed
and used in any manner consistent with
thtir labeling  until November 30.198-
From December 1.1HK7 until Apnl 15.
1988. these slocks may be sold,
distributed and used only in accordance
with the specific directions for use
attached to the October 1st Order. No
use of existing stocks  uiil be permi;;cd
af'.tfr April 15. I960
  The text of  the October Isi Order and
the attached Directions for Use arc set
forth below:
  Ir the Mutter of The Vnluntsry
Cancellation of Certain Pestic;dt Procjct
Regis'.ritioni Held by the Vctsicol Chcrr.,cd!
Corporation

Order Accepting Voluntary Cancellation
and Authorizing Use of Existing Stocks
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  11.198'. 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 accompanying
Conditions of Registration and
 Monitoring Protocol. Under the terms of
 the August 11 agreement. Velsicoi
 classified the following use* of its end-

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 42141.
rVri.-rjl  Register / Vol.  52.  No  212  /  Tiii'sil.iy  \ovi
r 3.  TOOT
            \f>t'l CS
                          "d^ie'rj

                  on ;ip;>!icition of
                      bv VrNitC'l :il!:>ut?d iir.lii crrl.nn
                      rondiliuns set forth in thr Conu.iimis uf
 n. :. *  i  f'nn \v'h.r. .1
 !:   :>!.! i,v htfTirtr.s (' structure"):
   I.  t'us! construction up^ii(:Al:on of
 rr. .  :;j', from outbid'.  structure lo
 ir.s.kic o; underneath a siruclurc;
  c The use of pressure roddire for
 pusJ-ronstruction application of muterial
 to ;i baseri.-nt-type or cran l-spocc lype
  ri. Prp- or post-ccnsirjction treatment
of :he urea underneath crawi-spuce and
post and pier type structures:
  e Tro.VT.cm of voids end spaces in
masonry cr block walls or areas behind
venders:
  f Applications by non-certified
  i> Soil-injection pressure redding at
pn-^surrs greaier lhar. 25 psi.
  The agreement fur'her classified the
folldwmg USPS of end-use termiiic-.de
products as "retained uses";
  a. Application to the outside perimeter
of any structure bj trenching, or drilling
through sidewalks  pat;os. or other
u"'T.dorfi slabs. ard applying material
in :iu' so.! without pressure (t?... flow or
g'.iv.ty fri'ili,
  b Applications bv the excavation
technique ! the cxter or nf any
"truri'.irr \i e . by re .TV". :np soil next lt>
."e foundation. placing 01 a tarp.
t:t. i.nj; w:th lerrrutii.idp. aril piacinc
(j,!t^ ;r. trench after soil dries);
  c Pn-ror.i! ruction lev, -pressure
jrr,;M~v:rr 25 psi) vertical roddmp (with
the dpp!.;j!;on rod equipped with a
pressure control device to prevent
hiphur pressures) of the perimeter
outside any structure;
  (2 Post-construction low-pressure
(maximum 25 psi) vertical rodding (with
the application rod equipped with a
pressure control device to prevent
higher pressures) outside slab and post
and pier type structures:
  e. 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 Velsicot's termitinde products.
the agreement included, inter die. the
following provisions;
    The retained uses were converted  to
restricted uses as provided for in
sections 3(dl and 4 of F1FRA:
    The registrations of the retained
usi-s wure amended to conditional
regulations. with no sole or distribution
                         Nn fi'-jhi-r ia!t. ::: di'lr>l:i,ii'-, In
                      Vi.-isii.al of ctid-uii; products lii! l.-d fi
                      deleted usi: was jiuwrd
                         Vclsico! amended the !dl>6H. thrsf toi.ks :::iiy he so',)
 rt'Mrilnitrd. ;tr,.l i. .cd oniy in lire  J.im r
 witri il;c (.mul.vr.s rf use pw;.  -'J in
 Appendix A u! this OnU'r. No ust will
 be permitted 4fier April 15.1908.
   EI'A believes tht tt;rms of this
 Surpiomer.i will iillow for an orderly
 and efficinni phase-out of chlor.Jane
 use. The Supplement provides sufficient
 time for the use uf the volume of existing
 siocks estimated by EPA to exist in
 Aucust of WC7. but will prevent
 unlimited use of such stocks if EPA was
 substantially incorrect in its estimate or
 if individuals possess large stor*piles.
 EPA favors a two-tiered appro...h
 because it encourap"' the use of
 application methods that are believed to
 pose less potential for misapplication
 and are beheved less likely to result in
 indoor exposure than the USPS that will
 be discontinued afur November 30.
 19C7.
   EPA finds that implementation of this
 Supplement is consistent with the
 purposes of F1FRA and will not have
 unreasonable adverse effects on the
 environment. EPA has previously
 determined that the agrfeme.it entered
 into on August 11.198". which contained
 no limitations on  the use of existing
 slocks, was consistent w;th the purposes
 of the Act. The limitations contained in
 this Order will not permit any greater
 use of stocks lh;in that w     O.P
 Agency has already four..,  ^ 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 subst; ^tially
 underestimated the amoun    stocks in
 the possession of applicatc-  ind
 distributors as of August 11.1987 or that
 individuals may have large stockpiles.
 by establishing a cap on use that would
 prevent the use of significantly larger
 quantities than the  amount estimated to
 exist by EPA. Second, these dotes allow
 for an orderly transition away from the
 deleted uses (with such uses not being
 permitted after November  30,1937). and
 eventually from all other uses (after
  April 15.1988). In particular, they
 provide EPA. Velsicol. and the National
  Pest Control Association with an
  adequate opportunity lo notify
  applicators and state enforcement
  agencies  of the terms of this Order, the
  dates will not encourage a hurried use of
  existing stocks which could lead to
  misapplication and greater indoor
  exposures: and they will allow for the
  ccrt!.rn,jtion of appliLjtors {use of liie
4

-------
                  Federal Roister / Vol  52. No. 212 / Tui-"'-y  November 3.  19 fT  /  NVlccs
                                                                      4214:
i utirse stocks will be  restricted \jsr-
* scl fr.nh in FITRA sections 3/d) and 4
.if'.-r \o\mb>r 30. 1987J. Finally, the
d.itus reflect iniurmjtpon provided to
KK\ iKii even though there may well
h,u r b<  n only 1 50,000 g.illons of
txis'ir.s ,U)cks in the hands of
ur'',-nc.j!i)rs and distributor* on August
11 190". the rate of cKlordane use has
decreased sinrft that date, and will of
necessity decrease) even further after
NIM ember 30.1907 when certain uses
w-ii'i no longer be permitted.
  Dasrd on all the foregoing, pursuant to
riVRA section 6(a](l):
  1. The following registrations of
Velsicol's End Use Products arc hereby
cancelled:
  A The End Use Product described in
Section I1.A.2 of the attnched
Supplement (that product currently
assigned EPA Registration Number 876-
233 bearing all uses  of Gold Crest
Termide other than the retained uses).
  D. The End Use Product described in
Section II.B.2 of the attached
Supplement [that product currently
assigned EPA Registration Number 076-
63 bearing alt uses of Cold Crest C-100
other than the reta.aed uses).
  C. The End Use Product described in
Section II C.2 of the attached
Supplement (thai product currently
issipned EPA Registration Number 876-
1U4 bearing all uses of Chlordane 8EC
Termite other than the  retained uses)
  D. Cold Crest C-50 (EPA Reg. No.  876-
135)
  E Cold Crest H-60 (EPA Reg. No.  876-
135)
  F. California SLN  for crawlspace
perimeter spray (Termtde) (CA-810012).
  G. California SLN for crawlspace
perimeter spray (C-100) (CA-810011).
  H. Hawaii SLN for crawlspace
perimeter spray (C-100) (Hl-650003).
  2. The sale, distribution, and use of
existing stocks of any products in the
possession of persons other than
Velsicol on or after August 11,1987
bearing Registration Number* 875-63,
1376-65, 676-86. 876-104, 876-233. CA-
310011. CA-810012, or Hl-650003 is
iubject to the following conditions:
  A. Such products may be sold.
distributed, and ustd In any manner
Consistent with their labeling until
November 30.1987.
  B. Such products may be sold.
distributed, and used from December 1.
1987 until April 15.1968 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 IS. 1988.
  D Any such products that have not
been uf.ed on or before April IS, I960
must be disposed of in accordance with
applicable federal, state and local laws.
  It is sc ordered trm 1st ri.iy of
("kinder. 198?.
I)'>;ic!.i5 U Cimrii.
/) re: l>jr. O;'fn.e ofPi-nln idc Fr^,-?ii;ii
Appendix I Voluntarily Cancelled
Subterranean Termite Control Products
Directions (or Use Between December 1.
1987. and April IS, 1980
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 Temile
Treatment
  Effective preconstruction
subterranean termite control equire
the establishment of an unbroken
vertical and/or horizontal chemical
barner between  wood in the structure
and the potential or existing termite
colonies in the toil. To meet FHA
termite proofing  requirements, follow
the latest edition of the Housing and
Urban Development (HUD) Minimum
Property Standards.
Dilution Instructions for Cold Crest
Termide
  Use a .75% water emulsion for
subterranean termites other than
Coptotermes spp. Mix 1 gallon of Cold
Crest Termide in 99 gallons of water to
produce a 0.75%  water emulsion. Usa 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
produce a \~  nv.cr *nn:Ui'T.  '.'.. i 1-
2 a water emulsmo fur ('. v" ''rij: .-. >,pj
VkhlTi' nPrr^i.Tfy Mix 1-J c.i. :'!. .if
product in 93 
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       T>
        \     UNITED STATES ENVIRONMENTAi

                        WASHINGTON, D.C
                                                          OFFICE OF
                                Q IQPO              PESTICIDES AND TOXIC SUBSTANCES


MEMORANDUM

SUBJECT:  Chlordimeform - Stocks at Dealer/Distributor Level

FROM:     Phyllis E. Flaherty WVfWo
          Acting Director
          Policy and Grants Division
          Office of Compliance Monitoring

TO:       Addressees


     Recently, I received a question regarding chlordimeform.
The question was:   "Would a dealer/distributor be in violation
of the Cancellation Order for Chlordimeform if a farmer pays
for chlordimeform prior to February 19 but does not physically
receive the product until after February 19, 1989?"

     Based on discussions with the Office of General Counsel
 nd 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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