United States         Pesiksdes and
             Environmental Protection    Toxic Substances   ;  .Washington, DC
             Agency           EnforcememDivision    20460 :>
&EPA
*"-rin     Federal Insecticide^ Fungicide?
                            •' '. '*.'•  . * ;-;          ,
             and Rodenticide Act
             Compliance/Enforcement
             Guidance Manual
             Policy Compendium
             Volume 3:  FIFRA Compliance
             Monitoring Strategies

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Table of Contents
Volume 3 of the FIFRA Compliance Enforcement Guidance Manual Policy Compendium contains the
enforcement strategies issued by the Office of Compliance Monitoring that are currently in effect.  The
Table of Contents of the remaining volumes, FIFRA miscellaneous sources, and a list of obsolete
documents are contained in the Appendices.

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

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

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

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

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

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

Strategy for the Enforcement of the Good Laboratory                                   01/15/85
Practice Regulations Under TSCA and FIFRA
FIFRA Compliance/Enforcement                                           Guidance Manual
Policy Compendium                          i                             September 1992

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Volume 3
Compliance Monitoring Strategy for Enforcement of   Pesticide
Registration Cancellations Due to Non-Payment Fees
                             Table of Contents
                        Volume 3:  Enforcement Strategies (continued)

                TITLE

Compliance Strategy for FIFRA §3(c)(2)(B) Suspensions
                                       DATE

                                      09/03/85

                                      08/21/90
Aldicarb

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

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

Compliance Strategy for the Cancellation of Non-Wood
Uses of the Inorganic Arsenicals

Request (Hickerson) for Modification of the Consumer
Information Sheet for Inorganic Arsenicals
                                      06/06/89


                                      03/01/90
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
n
Guidance Manual
  September 1992

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Volume 3
                             Table of Contents
                        Volume 3:  Enforcement Strategies (continued)

                TITLE

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
                                       DATE



                                      01/15/76


                                      01/22/76

                                      02/19/76

                                      03/23/76

                                      08/27/76


                                      11/23/76


                                      04/13/88
Chlordimeform

Chlordimeform Strategy

Final Compliance Strategy for the Cancellation of Chlordimeform
                                      02/09/89

                                      06/19/89
Compound  1080

Compliance Monitoring Strategy for Compound 1080
Livestock Protection Collars
                                      07/25/86
Daminozide (Alar)

Final Compliance Monitoring Strategy for Daminozide (Alar)

Compliance Strategy for the Agreement to Voluntarily
Halt Sales of Food-use Pesticides Containing Daminozide
                                       10/20/86

                                       06/14/89
FIFRA Compliance/Enforcement
Policy Compendium
in
Guidance Manual
  September 1992

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Volume 3
                             Table of Contents
                       Volume 3:  Enforcement Strategies (continued)
                TITLE
                                      DATE
Dinoseb

Compliance Strategy for the Emergency Suspension
of Dinoseb

Amendment to the Compliance Strategy for the Emergency
Suspension of Dinoseb

OCM Memorandum: Dinoseb

OCM Memorandum: FIFRA Section 18 for Dinoseb

OCM Memorandum: Dinoseb Stipulated Order

Compliance Monitoring Strategy for Final Cancellation
of Dinoseb

Compliance Monitoring Strategy of the June 9, 1988
Dinoseb Cancellation Order for the 1989 Growing Season
                                     10/07/86


                                     04/02/87


                                     04/17/87

                                     03/14/88

                                     03/28/88

                                     06/15/88


                                     03/03/89
DBCP
DBCP Suspension Order Enforcement Strategy
                                     11/07/79
EBDC Compliance Monitoring Strategy

Compliance Strategy for the Cancellation
and Registration Amendments for Pesticide Products
Containing Ethylene Bisdithiocarbamate (EBDC)
                                   03/12/90(a)

                                   03/12/90(b)
FIFRA Compliance/Enforcement
Policy Compendium
IV
Guidance Manual
  September 1992

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Volume 3
Table of Contents
                       Volume 3: Enforcement Strategies (continued)
                TITLE
         DATE
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)
         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

Compliance Strategy for Conditional Registration and
Voluntary Cancellation of Certain Mercury Biocides

Compliance Strategy Addendum for the Cancellation of
Phenylmercuric Acetate Pesticides
         10/28/76

         01/06/77

        09/12/90


        12/20/90
F1FRA Compliance/Enforcement
Policy Compendium
Guidance Manual
  September 1992

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 Volume 3
                              Table of Contents
                        Volume 3: Enforcement Strategies (continued)
                                                                                    DATE
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
Toxaphene

Toxaphene Cancellation Compliance Strategy
                                      01/01/83
Wood Preservatives

Compliance Monitoring Strategy for the Wood Preservative
Uses of Creosote, Pentachlorophenol, Inorganic Arsenicals

Compliance Monitoring Strategy for Non-Wood Preservative
Uses of Creosote
                                       10/23/86
                                      06/09/87
FIFRA Compliance/Enforcement
Policy Compendium
VI
Guidance Manual
  September 1992

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     ENFORCEMENT PACTS
       AND STRATEGY

        COMPLIANCE
   MONITORING PROCEDURES
WATER PURIFICATION DEVICES


       October 1980
              Pesticides &  Toxic  Substances
                   Enforcement Division
                   Office  of Enforcement
           U.  3.  Environmental Protection Agency
                  Washington, D.  C.   20460

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STRATEGY OVERVIEW -	1

BACKGROUND	2

?.I:--;LATSD INDUSTRY- - - ;	?

APPLICATION OF FIFRA	4
   Requirements of PI?RA
   PIPRA Snforcenent Authorities

HE-ZDIZS	6
   General
   Misbranding Purifier Claims
   Ineffective Water Purifiers
   Recall
   Other Violations of PIFRA
   Criminal Citations

COMPLIANCE MONITORING 	 9
   Program Development Overview
   Guidelines for*3election of Devices To Be Tested
   Inspection
   Post Inspection
   Testing
   Pesticide Enforcement Management System (PEMS)
   Outreach

CASE DEVELOPMENT	U

ALLOCATION OF RESPONSIBILITIES	,-15

ENFORCEMENT FACTS AND STRATEGY	19

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

	T_he .jtesting programjwill examine the purifier claim used by
many products.  If" a product" 'claim's" '"to be~~"a pur if re~r'~Wt""it 'doesi"~"
not remove test organisms in the efficacy test, the product is
deemed to be misbranded and subject to enforcement action under
?I7RA, including Stop Sale Orders to remove the product from the
marketplace.  The testing scheme designed for this program consists
of two"phases.  Phase I tests the ability of the products to
remove environmental coliforms.  Phase II tests specific bacterial,
viral and protozoan pathogens likely to be found in water such
as Pseudomonas aerogenosa, Poliovirus and Giardia lamblia.  To
substantiate a purifier claim, a product must pass both phases.
      if it fails Phase I, enforcement actions will be taken,
        spending time and money on the Phase II tests.
     The goal of the program is to remove from the market those
products which do not*purify water to protect the health of persons
who might rely on the products for safe drinking water.

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

     Because purification of  water involves the killing of micro-
 organisms,  which are  defined  as pests  in Section 2  of FIFRA, these
 products are regulated by the Environmental Protection  Agency.
 There  are two kinds of water  purifiers:  Those which employ a chemical
 means  to purify water, and  those  which use a  physical method.  While
 both types  are  subject to the provisions of FIFRA,  including but  not
 limited"to,  Sections 7, 8,  and 12 as well as  Section 2(p)  and (q), '
 only purifiers  utilizing  a  chemical  must obtain product registration
~a3''"pTe'scr ibeI"b"y"*Sec"fio'fl "5 ~0'f the" Act.	'Under- Sect Ion- 25-fe-n4-)~of		-
 ?I??.A  the Adainistrator 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 5*065, November  19,
 1976).

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

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

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

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Producers must register their establishments,
there.'may be some
producers who have not done
     Almost any available physical method that night kill a micro-
organism is employed in at least one product.   The most popular are
ultraviolet (UV) light, micropore filtration,  chlorine generators,
and ozone generators.  Ultrasound, reverse osmosis, electrolysis,
and distillation are other known methods used  by purification
devices (See Appendix I).  These types of devices are called "point-
of-use" treatment products,  since the water is treated immediately
before use.  "Small systems" treatment products treat water intended
bution 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 to enforcement actions under FIFRA.

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Application of FIFRA
     %

     FIFRA and  its  isple.-er.ting regulations clearly apply  to  devices
The requirements  of these regulations are outlined below.   State
lavs are often  ambiguous where devices are concerned.

     Since it is  desirable that Stop Sale Use or Removal Orders
have nation-wide  applicability, this policy is  to be  administered
as a federal program.  State  inspectors who 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
f-3?r.A-r--^h^- a-p-pli-eabl-e- •se-etl-on-s--- include- but- -are. no-t-lj. ait. ed-Jbo-.^^.u). ....
and (q), 7, 8* and 12 of FIFRA (see 40 CFR 162.10 and  41  Federal
Register 51065, November 19,  1976).  Based on these sections,  the
water purification  devices are subject to the following  requirements

     "Establishment Registration  (Section 7)
        -Registration of all  producer establishments;  establishment
            registration number on all products
        -Annual reporting of  products

     "Books and Records (Section  3)
        -Must keep  records of brand name of device
        -Vast keep  records of production data
        -Must keep  records of distribution
        -Must allow an authorized Inspector to  examine
            these records
                                                                    !
     'Product must be properly labeled (Section 2 (p); 4
        -Must bear the Establishment Registration Number
        -Must include warning and caution statements
        -Must not be an imitation of other products
                                                       40  CPR  162.10)
     "
      Product must not be misbranded (Section 2 (a)).  A product
        may be misbranded if its label:
        -Lacks adequate directions for use
        -Lacks adequate warning or caution statements
        -Bears a statement which is false or misleading in any
            particular
        -Bears a false or misleading statement concerning the
            effectiveness of a product
        -Bears a statement which directly or indirectly implies that  the
            device is recommended or endorsed by any agency of the
            Pederal frovernment
                               —l—

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     For greater detail, consult 41 Fede. -1 Register 5*065,
"oveaber fg,  1976.  All req.uireaents of device producers described
in that document apply to producers of water purification devices.
     «

FIFRA Enforcement Authorities

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

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

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.-.erne lies	

C-er.eral

     FIFRA provides several remedies for violations of..its provi-
sions.  If the purifier efficacy claims are found to lie  false, a
serious public health hazard can exist, and a Stop Sale, Use, or
Removal Order will be issued immediately to limit the availability
of the product.  Penalties for other violations are to be determined
through*application of the general FIFRA penalty policy and matrix
(39 Federal Register 2771, July 31,  1974).   Civil penalties for
misbranding violations, which are applied in addition to Stop Sale
Orders, are to be determined by consulting the penalty matrix for
Ineffective Water Purifiers, below.   If there are severely misleading
claims, particularly in advertising material, the case may be
referred to the Federal Trade Commission through headquarters.
Xisbranding Purifier Claims
                                                      by te continue-
sale or use of the product, and will not be lifted until the product
comes into compliance with the Act.

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

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

Ineffective Water Purifiers
1.  Category A

2.  Category 3
                           I

                         5000

                         1000
                                II

                               5000

                               1750
 III

5000

2500
 IV

5000

3200
5000

4500
        See A. S.  Cor.roy's Memorandum of September 12,
.nal~Regulation Section  13, FIFRA."
                                                        1930, "Interim
                               -6-

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Category A - Products  in this category failed Phase l' 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 wit-h a potentially
             severe health hazard.

Category 3 - 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
         ......... vbuld "bring the product" ""int'0''c'omsl*iatiTrg''wi^h-
             A Stop Sale Order would be issued in such cases, but it
             may be lifted when the manufacturer agrees that he will
             immediately incorporate those changes which appear to
             have a reasonable likelihood of remedying the problem.
             The "modified'1 device is, of course, subject to
                                                             testing.
Recall
     Another remedy that  is used either as an alternative  to  a  civil
proceeding or in addition to one is a  recall action.  Recalls may
be voluntary or compulsory.  If this remedy is employed, the  guidance
in Section 12 of the Case Proceeding Manual should be followed.
    2]  For example, UV light kills viruses and bacteria but may
permit G. lamblia cysts to persist in water.  Since the cysts are
relatively large, a pre-filter on the system could predictably
remove them.  Another example would be a chlorine generator whose
directions do not explicitly indicate "'--  	-_-,.-•-- .-^
time that are necessary for chlorine
                                      the concentration and contact
                                      o effectively disinfect water
                               -7-

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     Other  Violations  of  FIFHA

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

         If  enforcement  actions  based  on violations of FIFRA which
     do not include  the efficacy  of  the product  are taken before the
     efficacy tests  are complete, the  complaint  or warning should
     clearly  state that additional action nay be taken if the results
     of the efficacy test should  prove  to be  unsatisfactory.  We recom-
     mend that all civil  actions  be  initiated at the same time.
	  Ori-i-na-1—G-i--tsrbion-s—
          Willful  violations  of  FIFRA may  justify the filing of
     criminal  charges  against  a  manufacturer.   PTSZD  concurrence
     would be  reauired for  criminal  actions.
                                   -3-

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z.cLi2-T.c9 Mc*i" t criru?
   •Sfven below are procedures for the compliance monitoring aspects of the
ogram with description of responsibilities and data flow


   T-ui ielir.es for Selection of Devices To Be Tested

   0   CM3-PT5Z) will select the devices to be tested and determine the
      order cf testing based on criteria noted below.

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

   0   Two categories will be established to help determine the order
 _ 	 g£. ^e^^^-r.
      -  The first category,  which will be given the highest
         priority, will contain those products  for vhich
         there is reason to believe that a violation
         has occured.  This will be determined  by consumer
         or competitor 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 crioeria as the number produced and dis-
         tributed, and the availability of testing space.   If
         production data is not available for all -devices,  the
         order of testing will be determined by random selection.

   0   CMB-PTS3D will prepare the sample request forms and  forward
      them to the aotroiriate Region for collection.
   Inspection

   *   At the opening conference:

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

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

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        Inspection of books and  records  will be  performed  in  accordance
        with the Pesticides Inspection Manual for  the purpose  of  deter-
        mining compliance with the record keeping  requirements (§3).
          *
        AT. 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
           form.

        -  Because many of these devices are very  expensive, the .
       	ins.pectar...shauld-i£2ke.,2A...a^^		
           donate the device, "any manufacturers  have already
           indicated a desire to have their devices tested, and
           a willingness to donate them  for this purpose.

        -  If the mamfacturer 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 rsarufacturer requests  to  install  the device himself,
        arrangements with the testing laboratory should  be made
        through C!-3-?TSED.
        If
entry is denied:

The inspector should follow established procedures
for denied entry. £'

If a distributor of the product can be located
through reviewing-the advertising or contacting a
local trade association, then a marketplace sample
can be obtained.
     £/   Barlow's  Decision:   Guidance  to Re.'rional  Personnel:  Conduct
:f Inspections  after the Baric/.-'3 Decision (April  11,  1979)
                                       -10-

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        -  If a product sample obtained fron the marketplace
           fails the efficacy tests, a warrant to conduct an
           in-depth bocks and records inspection may be
           obtained.  This will be necessary if production
           and distribution data is needed.
III. ?cst Ir.srection
        When the requested, sample has been collected,  the "PRD
        Acknowledgment" copy of the sample request form will be
        forwarded to CX3-PTS3D with the "Sample Identification"
        section completed.

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

        -  A second copy of the device's labeling  is to be assembled
           by the inspector and forwarded to CH3-PTSH) for contract
           nsnagement purposes.
IV.   Testins
     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 any possible defects resulting fron shipment.

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

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

        -  date the official sample was received

        -  date testing was initiated and completed

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

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

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

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


V.   Pesticide Enforcement Kanasrement Svstem (PS*S)
     The Regions --all keep PTSSD informed as to the enforcement status of
the device by entering relevant information, such as the date they issued
a particular order or penalty, the results of the enforcement action, etc.
  to the PE'S Computer system.
VI.  Outreach
     y.arr/ manufacturers of water purification devices do not appear to be
aware cf Section 7 establishment registration requirements.  To help notify
industry of these requirements, a letter to potential manufacturers and
their trade associations has been prepared (Appendix II
     The responses free this letter will allow the Agency to compile an
accurate list of manufacturers, their products, and production and distri-
bution data.

     A press release has also been prepared announcing the program to the
sub lie and notifying industry of the establishment registration requirements
(Appendix g&A

     As a result of this outreach program, it is anticipated that the
public and the industry will report the existence of various companies
which they suspect are not in compliance with the Act (establishments not
registsred,  products are ineffective, etc.).  All information obtained by
the Regions should be forwarded to CM2-PTSED, Compliance Monitoring
Coordinator.
                                       -12-

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     Microbiological data generated "by this prograa will be submitted tc the
Journal of Applied and Environmental Microbiology for publication after the
enforceaent cases are completed.  The results of the tests may also be
^resented at the '932 Annual Meetings of the American Society for Microbiology.
 ^v The results of this program are also of interest to the National
Sanitation Foundation and D-19, Coaaittee on Water Microbiology of the
American Society for Testing Materials.  It is pssible that presentations
     be na.de to these groups.
     Regions may release information concerning individual cases in the sane
namer that such information is handled in other civil proceedings.

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           PTSED

o reviews test results and
  labeling
o maintains a file of test
  results, labeling, and action
  taken
              notification of
              action taken
          • Region
o-reviews lab's report, labeling
  arid any records collected to'
  determine possible violations
o defamines enforcement response
  and initiates action
o maintains official enforcement
  file en devices
                     test results &
                  enforcement jacket
                                                         PTSED

                                            o requests samples
                                            o monitors program
                sample
                request
             Region
o sets up enforcement jacket
o collects sanples, performs
  inspections
o sends PRD Acknowledgment to
  CMB-PTSED
o sends copy of labeling to
  CMB-PTSED                r
                sample &
                enforceaent jacket
           test results
                              -13-a-

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     Case development will proceed in accordance with the Case
••rcoeedi-nss Manual.  The Regions are ai vised to avail themselves
 f the option of Enforcement Review through headquarters.   The
*abel review will be done by the Registration Division using"
the product performance criteria developed for evaluating b'oth
chenieal and physical water purifiers and the data on produtt
performance from the efficacy test.

     Please note that a civil complaint should be issued along with
the Stop Sale, Use or Removal Order when the product fails the
efficacy tests.
                               -11-

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                          -r ~\n « CTr^*" ^" OTPC3^••"••'••^
                          ^O^rtilu.* Of rLrx:r^..iir!
This cr.art is a guide to the responaibilities for the different tasks in the water
riuriiication device enforcement rrogram.
           Headquarters (PTSrD)
                                                             Regions
1.    Identification of Purifier Devices

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

                                                 *  Regions submit information on
                                                    nerf products they becooe aware
                                                    of to Compliance Monitoring
                                                    Branch
2.   Selection of Devices to be Tested

     *  Cocpliance Mor.itorir,g Branch
        updates list of known devices
        and selects devices.

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

0  Compliance "onitoring Branch deter-
   mines nazies and locations of device
   •oroducer establishments; assigns
   inspections to appropriate Regions;
   orepares sample request forss and
          hen to Regions.
        sends
                                                 4.   Inspections and Sample Collection

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

                                                      0  Inspector performs inspection
                                                         according to FI?RA procedures
                                                         and guidance;  special instruc-
                                                         tions may appear on the sample
                                                         request form.
                                      -15-

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       Headquarters  (FTZZD)
            Region
                                                    Inspector ships sample(s) and
                                                    one set  of documentary
                                                    to testing laboratory, se
                                                    copy of  documentary sample to
                                                    headquarters.,
 Testing of Devices

 *   Laboratory (Environmental Health
    Center,  State of New York, Depart-
    oent of Health,  Albany, N.Y.)*
    performs efficacy  test according
    to PTSED approved  protocol;  furnishes
    results etc.  to PISSD  and the
	-Region.  -(S.ee-*I,3..-.below..) The ...lab  	
    will keep the device until  litigation
    is completed.
 Determination of Violations

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

"  Region revie*^ inspection data
   and its set of documentary
   material to determine existence
   of violations under PIFRA
   Sections 7, 8, or 1 2 as wel
   as well as Section 2(q)
   branding violations.

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

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            Headquarters (PTS3D)
                 Regions
                                                          Based on the laboratory's
                                                          determination,  the Regions
                                                          may initiate action on the
                                                          purifier claim.  This should
                                                          not preclude discussion of
                                                          the case with headquarters.
 7.   Determination of Appropriate                 7
     Enforcement Response

     *   If misbranding violation based on
        the purifier c la in has occurred,
        headquarters may provide additional
        information based on historical files.
	-.-i^T-rccr-i-ate-.records and. recomniendat.iQ.ns	
        •will be forwarded to the Regions.   If
        advertising is seriously misleading,  a
        referral to the Federal Trade Commission
        will also be made.
     Determination of Appropriate
     Enforcement Response

     e  A Stop Sale, Use or Removal
        Order (SSUHO) will be issued
        for all products which fail
        efficacy test.  A civil penalty
     	is...also_as_3es
        Region applies general FIFRA
        civil penally policy and
        matrix to determine appropria-'-
        level of actions for all .
        violations.
 8.    Znforcement Actions,  Litigation,
      Settlement

      8   ?TSH>  may,  under exceptional
         circumstances, initiate
         enforcement actions.

      0   Sections of the agreements
         which  involve label or product
         improvements to bring the product
         into compliance are to be sent to
         FT3ZD  for concurrence.
8.   pjiforcement Actions. Litigation,
     Settlement
        Regions will initiate
        enforcensnt actions
        (warning letters, civil
        complaints, SSURO's).

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

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

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

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

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                                                                  Regions
10.  Publicity
10.  Publicity
     *  Start of Program
        - Press Release
        - Letters to manufacturers and
             trade associations.

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

     0  Consumer Information determined as
      . .~_a...result. of_.thfi_whole_..prQgram.t	
        - nunber distributed
        - type of use/risk factor
        - conclusion to be drawn from the
          program.
        Release of information abc
        individual cases in the saW
        manner as' other pesticide civil
        cases.
                                      -18-

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Er.foreesgnt Facts and Strategy
     iix I:    Types of Purifier Products                       20
 ppendix II:   Leal Definitions,   "Purifier" and  "Device"      22
Appendix III:  Publicity and Outreach                           33
                                      -19-

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                                                                  Apendix I
     Water purification devices  employ a variety of  techniques  to purify water.
"ne most  common techniques are:

     e  Ultraviolet  light - Light  of wavelengths around 260nn damages  the KIA
       of exposes organisms.  If  the exposure time  is sufficient, the organisms
       are no longer viable.  Light may also be absorbed by the bonds of certain
       complex organic nclecules  which could result in photolysis of  those role-
       cules.  Efficacy 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 US  EPA Water Purification Device Testing Protocol.
       Duplicative  verification of results on the same types of products used
       to develop the protocol  is useful to the U.S. and Canadian Enforcement
       Programs.

     0  3u'cmicron Filtration - Some products filter  water through "sieves" whose
       pores  are about 0.4 micron.  Since a typical bacterium  is 1 micron in
       diameter, these products frequently make purifier claims.  Unfortunately,
       a very large virus would be only 0.1 micron  in diameter and sos 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 mac r molecules and cellular organelles.
       Whether it would be efficent on the scale necessary to  purify  water is un-
       known.

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

     0  Ozone  generators - Oxygen  from air is electrically ionized to  form ozone, a
       powerful oxidizing agpnt and disinfectant.   Unlike chlorine, ozone1' does not
       persist (it  rapidly decomposes to oxygsn) and cannot be easily measured.  It
       is difficult for consumers to know if the device is actually working or if
       so~e minor product failure has resulted in lower levels of osone production.
       Installation is complex  -  often done by the  seller - and cheaper products
       -ay be 'unsafe electrically.

     "  "Electric current -  Presumably the microorganisms are electrocuted by  the
            a=p of an electric current throu^i a water reservoir.
       Distillers -  These  products condense  stesm from boiled water.

                                      -20-

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        y.ic reorganises are killed by boiling.  Distillation can concentrate
        certain organic compounds.

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

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

     e  Potable water "rurifers" - These products use the term purifier on
        their labeling but are clearly intended for use on water that •
        is already potable (i.e., faucet "purifiers" for use on municipally
        treated water).  Manufacturers of these products should be warned
        that use of the term "purifier" is for products which process
        untreated water.  (See 41 Federal Register 32778, August 5, 19.76)
        Other enforcese.it actions may also be necessary. •

     0  Large purifiers which treat water for groups of twenty-five, persons_
        or more.  These products are regulated by ?I7?A.  However, the quality
        of the water is remulated 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.)
                                      -21-

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                                                             Appendix II
                   Legal Definitions.  "Purifier" and  "Device


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

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

""  ' "  2'.'" Guideli nes' for Registering - Pesticide-Products -i-n -the  Un-i-ted•••••States-	
          Section  G:   Product Performance Standards for  Water Purification
          Devices.

       3.  EPA ruling In re  Contact Industries, Inc.,  I.P.  & R.  Docket No.  II-?36
          (1973) pg. 5~:

 3.     Devices

       Pest  Ccntol  Devices and Device Producers: Consolidation and Clarification
       of Hequiresents.  Federal Register, vol.  41.  no. 22?  Ul/19/1976).
                                        -22-

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                          IN THE'MATTER OF •

          ••SIECO PRODUCTS  COMPLY, INC.,ET. AL.

   ORDEB, OPINION, ETC., IN BECABD TO THE ALLEGED VIOLATION OP
   '                %FEDE£AL TBADE COMMISSION ACT       '  *
  brder' requiring  a'Vcw  Jersey manufacturer' 6r water Vilha ton to ceaa*
     "miepr^"ba'  the «K«*ver.eM ar.d capability of ite water filtration
          -and deceptjvely guaranteeing the performance of auch unita. *
                                                 f   •      -i217

                            t Opinion
..^.  Implied .  . ;:r.er.ts and sales literature as to
the purifying qualities  of tlui:  unit.

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--•-:~?;  r.rc.7, jr>::  er iucoar: u:  Guidelines  fcr Recistraticn-of  Pesticides •;•
live L'r.itas States:  rrccuct  Perfor  jnca Stancards (pg*  14.5-146).   (Full  taxt
a'vaiUiie frcr, he-idquartsrs.)             •''             '   -  '          +
          elements: representative levels of organic-and inorganic soil


          contamination; various water temperatures; the specific dosage
                       * «
          and exposure period recommended for the proposed product; a


          variety of test microorganisms representative of the target pests

                                                              ,f
          Co be controlled; and quantitative detersination of the level of


          microbial contamination of the vater before and after treatment.


            (ii)  Performance standard.  The treatment oust eliainate all

          test cicroorganis^s frca the vater.


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


          intended for the treataenc of rav water to elininate the potential


         ' health hazard posed by nicroorganisas is identified as a water


          purifier.  The unit nay .rely on physical filtration4 (pesticidal


          device), or chemical treatment (pesticide), or a combination thereof,


          to achieve the intended purpose of purifying aicrobioiogicaliy ncn-


          potable vater by eliminating watar-bome pathogens in the vater


          itself.  Those units, such as subaicron nesbranes and absolute filters,
                                                         9

          vhich rely solely en a physical reans for removal of sicroorganisas


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


          to regulation but not registration.  The test requireaents indicated

          below are for the units containing an antimicrobial agent.


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


          vater purifier ur.ir aust be conducted under conditions representing


          actual use employing a defined raw vater source containing a high


          level of microbiological polluzicn.  The test design wil  vary
                                        145

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


such basic elements as: representative levels of organic an/i in-
              * •

organic soil contamination; various water temperatures; documen-


tation of the antimicrobial concentration found in the test system;


and quantitative determinations of the nicrobial conCanination


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 oust be documented.


  (B)  Performance standard*  The treatment oust eliminate the


cicrobial pollution in the rav vater*


  (il)  Potable varer'treatment unit.  Any unit intended for phys^


ical and/or chemical traaaent of aicrobiologically potable water


from a municipal treatment facilit7 to remove undesirable tastes


odors, chemicals, or other aesthetically objectionable properties


is identified as a pocable vacer treatment unit.  A substrate such


as activated charcoal (with or without a bactaripstatic agent) is


incorporated into the unit for this terminal processing treatment


of potable vater prior to consumption.  Since the requirements of


the Safe Drinking Water Aic do permit municipally-treated drinking


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


which are coxaonly recognised contaminants of vater, an antimicrobial


agent is sometimes incorporated in a potable water treatment unic


to provide bactarioscatic activity against these contaminants.  Only


pocable vater treacment units containing a bacteriostatic agent are


urder the purview of  the Act.
                                146'

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' .'-xerpt fror, In  re  Contact Industries.  Inc.  (pg. 6-8).  (Full  text  of document
 •.available from  headquarters.)
                        ENVIROi{".r.:ttAL  PROTECTION  AGENCY
                       BEFORE  THE  REGIONAL  ADMINISTRATOR
                                               *

       In  re                                  ) .                 '
          •    Contact Industries,  Inc.,       )    l.F.  & R.  Docket No.  II-1S6C
                           Respondent        )     '    Initial  Decision
            The  term  purifier connotes  a  product  which  eliminates  impurities
       and  polluting  natter.  We  are  in agreement with  the conclusion of
       Complainant's  export witness that  the "word ourifier is suffir.i~:r!+>\v
       broad to  include  ridding the air of nb.iectionables, includinq  riirrn-
       organisr.ij as they would exist."  An air purifier would  therefore
       cleanse the air of air-borne b?.cteria,  virus,  and fungi particles.   If
       Respondent had intended for the  product to be  understood to be merely
       an air freshener  or deodorizer,  the label  could  have contained the
       term air  freshener (cf. Respondent's Ex. 7) or been limited to the
       claim that the product was an  industrial odor  absorbent and not also
       a glycolix.ed air  purifier.  In fact, the latter  phrase  would be
       somewhat  redundant in the  context  in which it  is employed on the
       label if  all that was intended thereby  was to  inform the consumer
       that the  product  functions as  an air freshener.   As indicated  by
       •Complainant's  expert witness,  the  term  air purifier especially when

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                          .   - 7 -

taken together with the word "Sanicidc" on the label would indicate
that tlvj prO'Jjcl is intended to rid the air of genus, that is,
bacteria or viruses.
     "Sanicide" is printed in bold-face, conspicuous type on the front
of the label.  The word also appears at the top of the back of the
label in type which is in Urger and bolder print than all other words
on that side of the label.  It is clear that the word "Sanicide" is
meant to provide the ir.ost conspicuous reference to the product.
     "Sanicide" implies both a sanitizing and a killing action or, at
the least, a killing action.  Sanitize means to free from dirt, germs,
etc., as by cleaning or sterilizing.-  The suffix -_cjde means killer
or killing.  So* lobster's Third Hew International Dictionary  (1255).
A consuinsr would, we believe, recognize the meaning of the suffix
-cide as is evidenced by the common usage of words such as homicide,
pesticide, and insecticide.
     In interpreting broad remedial legislation, the consumer  is not
assumed to be an expert or one possessing special knov/led^e or
ability, and includes "the ignorant, the unthinking, and the credulous."
United States v. An Article. . .Consisting of 216 Ortonsd Cottles,
supra at p. 740 and cases cited therein1, United States v. An Article
of Drug. . .47 Shipping Cartons. . .. 331 F.Supp. 912, 917 (0. Md.
1971).  Nor can 1:2 assume that the buying public will exercise great
selectivity and caution in what they choose to believe: of what they

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read.  UnitLCJ States v. Articles of Drug, Etc.. 263 F.Supp. 212 (0.
Neb. l?f>7).  Cf. Holliros fetch Company v. Federal Trade Ccvrm'r.sicn.
310 F.2d 863, , 859 (D.C. Cir. H>52), cert, denied 372 IKS. 976
                                                          *
(1952), rehearing denied 374 U.S. 857 (1963), 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 microorganisms present in the area sprayed.  This  is especially
so when the term "Sanicide"  is read in conjunction with representations
that the product is an air purifier or a glycolized air purifier.
Certainly, the use of the prefix sani- with the suffix -cide has
greater significance than the use of that prefix in other  contexts
disclosed  in the record.
     Antimicrobial agents are specifically included as one of the
classes.of sanitizers or pesticides subject to registration under  the
The claim that the product  Superior  Sam'cide Air  Purifier  is  an  air
purifier when read in conjunction  with  the  word "Sanicide"  would indi-
cate that the product is  indeed an antimicrobial  agent  "intended to
reduce the number of living bacteria or viable virus  particles on
inanimate surfaces, in water,  or  in  air", in this case.  See  40  CFR
                                        I/
162.3(ff)(2)(i)(B) (Emphasis  supplied).     Thus,  representations made

     T7  Hicroorg;t:)i::ii3, "inr.li'ding but  not  limited to algoc,  fungi,
and bacteria, and viruses have bc«n  declared by the Administrator to
be posts \;;-.cn tl:oy oxist  under circi.'::;staiiccs that i.iiikc  ther. deleterious
to man or tho onvircraent (Sec 40  CKR 162.14(b)(4) and  (5)).

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        UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                      WASHINGTON. D.C. 20450
                          JUN   8 198!
                                                OFFICE OF ENFORCEMENT
MEMORANDUM

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


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

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

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

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

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                           - 2 -

     I am also attaching an amendment to the Guidelines for
Assessing C1v11 Penalties pursuant to FIFRA.  This amendment
adds violations of the CRP regulation to the C1v1l 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, D/rector
                            Pesticides and Toxl^/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 CONS IDE-RAT IONS

     Program Management and Allocation of Responsibilities
     Program Integration

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i
 _J_ for_the _E_nforcement of_ the Chi ld_R_es 1 stant
ra_ck'aging""ReguTa'tiori""UndTr" FTTRA"                  "
 Overview
     On March 9, 1979, the Environmental Protection Agency
 published a final  rule at 44 Federal Register 13019 (40
 CFR 162.16) which  requires chil'd rel'lstant 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 Jt\as not
 been classified for restricted use, and (3) it meets certain
 toxicity criteria.  Exemptions may be granted for products
 for which special  packaging is not technically feasible or
 where the toxicity criteria are not indicative of hazard to
 humans.

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

 Requirements of the Rule
 Applicability

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

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                           -2-


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

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

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

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

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

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

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


    0   "Residential use" - A pesticide meets this criterion if
        it is applied (other than by a commercial applicator)
        directly to humans or pets or is applied in, on or
        around all structures, vehicles, or areas associated with
        the household or homellfe 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   "Toxidty criteria"  are defined in 44  Federal  Register
        13019 (March 9,  1979) and at 40 CFR 162.1 6(C)(2).	

Exceptions to CRP

    0   "Dormant" Product Registration

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

    0   Toxicity Data

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

    0   Products for Residential Use by a  Serviceperson

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

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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 .orosecutorial discretion and
        not take enforcement action if a subject product is
        not specially packaged but is labeled or sticker-labeled
        with a statement restricting the product's sale, use,
        and storage to servicepersons, e.g., "Only for Sale
        to, Use, and Storage by Servicepersons."  The statement
        must appear in type size at least as large as the
        child hazard warning statement.  Labels need not be
        submitted to the Agency for approval but must be submitted
        for the official label file used to determine compliance
        with FIFRA.

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

Exemptions to CRP

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

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

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

    0   Develop and test special packaging

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

    0   Amend registration - Cert, i f i rat 1 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 the requirement must be in child
resistant packaging if released for shipment  after
March 9, 1981 .

ILecordkeeoi ncL
Certain records must be retained by the applicant or
registrant for as long as the registration 1s valid.
These records shall be available, upon request, for
inspection and copying purposes or for submission
to EPA.  The records which must be kept are:

(1) A full description of the package including:

    (i)  A full description of the container including

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

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

         (A)  The name of its manufacturer,

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

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

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

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

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

Regulated  Industry
    The regulated community consists of registrants of those
products subject to these regulations.   Estimates  suggest  that
approximately 9000 products may be involved.

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

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

Enforcement
Objectives

    The objective is to assure compliance with this regulation
so as to minimize or eliminate accidental exposures to highly
poisonous pesticides used in and around residential areas.

Outreach

    Registrants should be aware of the 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

        Hjsbranding - §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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                     -7-
 to  §25(c)(3)."  Failure to have  special packaging
 for those products released for  shipment after March
 9,  1981, would make the product  misbranded  if it is
 subject to the special packaging requirement.

     There are three variations of this violation:

          (1)  No special packaging, although required.

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

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


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

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

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

 Failure to Maintain Reports Rpginpprf.- §12(a)(2)(B) of FIFRA

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

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                            -8-


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

                      of Application/Report or of Records
        ^ntaine
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                              -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-
  e 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 canceUation
        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

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                            -10-
st a t u s or the validit.' of t li o d a t 
-------

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

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

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

Product

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-

5.
6.
7.
8.
9.
10.
11.
triazinetrione
Hydrochloric acid
Phosphroric acid
Chlorophenolics
Sulfamic Acid
Quaternary Ammonium
Compounds 	
Parafomaldehyde
Formaldehyde
99%
8%
17%
6%
20%
105
95%
37%
Use
swimming pool
                                             Swimming pool

                                             Toilet bowl

                                             n       ii

                                             Disinfectant

                                             Toilet bowl


                                             General disinfectant

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2.
and Rdenticide
Pesticide Chemical

1. Carbophenothion


2. Chlordane


3. Chlorpyrifos (Dursban)


4. Cryolite

5. Oiazinon



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


          28.0


          9.0


          15.0

          7.0



          17.0

          0.4



          1.2

          3.5


          10.0

          6.5


          20.0


          2.0


          18.0

          6.2

          1.1
                                           Remarks

                                      Some lawn use
                                      products

                                      Termite control
                                      products

                                      Sprays for outdoor
                                      Ornamentals

                                      Plant dusts

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

                                      Slug and snail
                                      control

                                      Insect, slug and
                                      Snail control
                                      Rodenticide

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3. Hprhicidgs and Fungicidfis

Chemical                 Formulation / % A.I.

                              Above 0.5%

                              any %

                              above 88%

                              above 40%

                              above 5%
Bis (tributyltin) oxide

Paraquat

Pentachlorophenol

Chlorothalonil

Copper-8-quinolinolate
  bo Engler, (thief/'
Disinfectants Branch
Registration Division  (TS-767)


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

                                                  Wood Presenvative

                                                  Homeowner  herbicide

                                                  Wood preservative

                                                  Homeowner  fungicide

                                                  Wood preservative

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

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

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

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

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

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                              - 3 -

must be limited to changes required by the letter in order to

maintain the exemption from compensation requirements.

Combined Application in Response to Multiple Label  Improvement
Noti ces

     Applicants receiving multiple notices requiring LIP labeling

amendments for the same product may combine responses into one

application for amended registration provided the relevant LIP

Notices are clearly referenced.  Applications that  are  non-compen-

sable under FIFRA section 3(c)(l)(D) may not be combined with
     /
applications that are compensable.  The submission  deadline for

combined applications for amended registration is the later of

the deadlines established in the LIP Notices.

Time Frames for Compliance	

     Any product released for shipment 180 calendar days after the

registrant receives RD's acceptance of amended labeling must bear

that accepted label.  Registrants are responsible for compliance

by their sub-registrants (distributors).

     Products that have been released for shipment  and  are in

retail  channels of trade prior to the 180 day deadline  may continue

to be distributed in commerce, sold and used until  supplies are

exhausted.


Enforcement Objectives                                          ~


     The objective of LIP compliance program is to  ensure that

product labeling is in compliance with the requirements of the

various Label  Improvement Program Notices.   This  will  be accom-

plished through producer establishment inspections.

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

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     4) Salt Water Erne sis - 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	^	
                                                          • V

     The Registration Division, OPP is responsible for compiling

lists for each LIP Notice consisting of:

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

These lists, which the Compliance Monitoring Staff will forward  to

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

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.

-------
to respond to the.LIP Notice; and b) label amendments RO has

approved.  Inspection priorities will not include registrants

whose products have label amendments pending with RD. -Priority
                                                       «
for inspection should then be as'signed on the following basis:

     1) Registrants of products subject to cancellation for failure
        to respond to the LIP Notice.  These registrants should
        be ranked based on the number of their products subject to
        the LIP Notices in the following order: Fumigants,  Termi-
        ticides, Antifouling Paints and Salt Water Emesis.

     2) Registrants with the most number of products with accepted
        amended labels subject to any LIP Notices in the following
        order: -Fumigants, Termi t i'cTd'e'sy "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.


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 conpliance with any LIP

Notice will be issued a Stop Sale Use or Removal  Order (SSURO) by

-------
                                - 7 -

the State or EPA in addition to any enforcement action taken by
   «
the State or EPA.  The SSURO will be removed only:after the registrant

brings th-e product into compliance.  SSURO's will  not be lifted for
                                                       »

cancelled products sold in violation of a cancellation order.

Issuance of a SSURO is an appropriate response to  non-compliance

as the LIP is designed to mitigate the risks of handling pesticides

through labeling changes and the registrant is given ample time

to make and incorporate these changes on the label.


Allocation of Responsibilities

Headquarters Responsi bi1ity	

a) Provide Regions with a compliance strategy for  Label
   Improvement Program,
                                                '            •   v,
b) Provide Regions with copies of each LIP Notice,

c) Provide list of registrants affected by a Notice,
   status of the products affected and date of accep-
   tance of final printed labeling for each product
   i n compli ance.


Regional Responsibility	

a) Provide copies of all pertinent materials to the States.

b) Provide guidance and assistance for State enforcement
   efforts.

c) Assist in issuance  of SSURO's.


State Responsibility	

a) Schedule and conduct inspections of affected registrants.

b) Issue SSURO's to non-complying registrants.

c) Take enforcement actions where appropriate.

-------
                      UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                  WASHINGTON. D.C. 20460
                                                                   AMO TOXIC SUBCTAMCCS
         MEMORANDUM

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

         TO:        Al vi n L. Aim
                   Deputy Administrator


              Attached is the Compliance/Enforcement Strategy for the
         Federal  Insecticide, Fungicide, and Rodenticide Act.  The
         strategy  was  developed by a work group composed of Headquarters,
         Regional,  and State pesticides personnel, and reflects the vi-ews
         of al 1  parti cipants.

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

              The  strategy is based on the  assumption that adequate resources
         would  be  available to support a balanced credible program.  Because
         of actual  resource constraints, however, our primary goals through
         FY35 are  1)  to  maintain th-e present monitoring/compliance  level in
         States  with  cooperative enforcement agreements, 2) to negotiate
         cooperative  agreements with the remaining States, 3) to refine
         the  program  management and oversight activities and 4) to  further
         develop  and  expand the data audit/Good Laboratory Practices  inspection
         program.   To  meet, these goals, we  will perform the following activities
         through  FY85:

_       o  Write  FY35 Cooperative Agreement Guidance.

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

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

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                               - 2 -
o  Finalize enforcement response policy far data auaits/GL? inso^^B
   ti ons.

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

o  Provide technical and legal  support to States.

o  Provide training for State inspectors and chemists.

o  Prepare additional policies  for the FTTRA Policy Compendium,  as
   needed.

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

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

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

o  Along with States, continue  to certify new applicators,

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

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

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

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

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

o  Support all ruleaaking by the Office of Pesticide Programs.

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

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                               - 3 -

o  Update the Pesticides Inspection Manual.

o  Consolidate FIFRA £nforc£mfint Response Policies.
                              *
o  Revise FIFRA §7 establishment registration rule and reporting
   form to improve the usefulness of data in the system.

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

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

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                    FIFRA COMPLIANCE /£;trO«C£MEN7 STRATiG:
1
           Introduction                                           1
           FIFRA  Compliance  Program Overview                      1
           Previous Compl i ance/Enf orcamerrt Strategies             3
           Present State  of  Compliance                           12
           Goals  and Priorities                                  13
           Plans  for Achieving Program Goals                     15
            Compliance Monitoring Plan                          16
            Compliance Promotion Plan                           21
            Noncompliance Response Plan                         23
            Headq.uarters/Regi cnal Coordination                  2?
            Federal/State Relationship                          29
            Cooperative  Certification and ~ri: -.-,?•:
              Program              .                             31
            Cross Program Elements              ^               3t
           Program Evaluation                                    3.6
           Future Guidance                                       38
           Appendix                                              39
            Figure I -   FIFRA Case Flow
            Table I -    Enforcement Actions Resulting
                         from Grant Inspections FY81
            Table II -'Enforcement Actions Resulting
                         from Grant Inspections FY82
            Table III -  Federal Pesticide Compliance
                         Inspections
            Table IV -   Federal Pesticide Enforcement Actions

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                 FIFRA Compliance/Enforcement Strstecy
I ntroducn on
     T'nis document contains EPA's strategy for acrreving
taining compliance witn-tne requirements of the Federal .
Fungicide, and Rodenticide Act (FIFRA) as anendea and i m;
regulations.  The document provides an overview of tne ?'.
     T'nis document contains EPA's strategy for acrveving and main-
                                                        Insecti ci :e,
                                                         1enent in5
                                                        'IFRA com-
pliance/enforcement program, a summary of prior strategies, tne
existing state of compliance, the current goals and priorities of
the program, recommended strategies for attaining these goals, a
discussion of the roles of the Federal and State governments in
implementing strategy elements, a discussion of cross program
elements, and a description of the system for program evaluation.

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

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

FIFRA Compliance Pro gran Over view

St atutory / R e cu 1 a 13 ry Requirements	

     FIFRA, as amended, currently has a variety or ..idc/iar. i s.r.s -3  r~3-
tect health and the environment from unreasonable risks from pesticides
It contains the following requirements:

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

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                               - 2 -
o FIFRA §24(c) State registration for additional uses o •' i ~-r:5
  pesticide within a Stata to rceet special local naeas.
o Cancellation/suspension by EPA of pesticides *nich ;=.ie «.n-2iiop-
  aole adverse effects.
o Federal  registration of pesticide or device producing est 20 1 i 3 .Tier'
o Submisson of annual reports to E?A and maintenance of aooks am
  records  by each registered estao 1 i snment .
o Establishment inspections.
o Certification and training for users of restricted use pesticides
  by the States with- plans or EPA.  (Pesticides classified for
  restricted use may only be applied by or under the direct super-
  vision of a certified duplicator.)
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.

Imp! ersentati on

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

     Traditionally, primary responsibility for enforcing tne require-
ments of FIFRA has re-sided with the Federal  government.  I «. '?~2
however, Congress saved tne way to srsift resoons i oi 1 i ty t: ~ "e ^
by amending FIFRA to provide for "adara 1 / S '. ate cooperative .:--::-;~s
governing  pesticides enforcement and applicator training ana certi-
fication.   Congress furtne-r strengcnenaa cne raipons i j i '. i cy or" c.is
States in  the 1978 FIFRA amendments which establish the presumption
that States, under certain circumstances,, shall have primary respon-
sibility for bringing enforcement actions against  violators of
pesticide  use requirements (primacy).

     Most  States who enter into a cooperative enforcement  agreement
with EPA und.er §23 automatically obtain primacy as do States which
have an approved pesticide applicator certification plan (§4)
whicn also meets the criteria under §Z6(a) for adequate pesticide
use laws and implementing- procedures.  A State which has neither a
cooperative agreement nor an approved plan can also obtain primacy
if it has  adequate laws and procedures governing pesticide misuse as
required by §26 (i).

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

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               The  1972  amendments  to  FIFRA  require  the  certification  of
          applicators  to  apply  or  supervise  tie  application  o~  : e:: •':i les
          classified  for  restricted use.   Congress exoected  States  to  certify
          applicators  and  authorized funding  support.  The State  Cocoerative
          Extension  Services  were  to be  utilized  for  the  training  of  pesti-
          cide  applicators  *ith  EPA funding  support.

               As of  October  1983,  all  but 4.  States  have  funded  coooerative
          enforcement  agreements;  all  but  3  States have  been  granted  use
          enforcement  primacy;  and  all  but 2  States  have  aporoved  certification
          plans.  As  th-ese  figures  indicate,  most FIFRA  enforcement  and  certi-
          fication  and training  responsibilities  rest  with the  States.   EPA
          activities  include  oversight  of  States  with  agreements,  talcing
          enforcement  action  for cases  referred  by the States,  conducting
          enforcement  and  certification  and  training  activities  in  States
          without cooperative agreements,  and  conducting  national  compliance/
          enforcement  programs  in  areas  where  States  have  limited  jurisdiction
          or capability such  as  data audits/laboratory inspections,  import
          and export  surveillance,  and  rodenticide/device  testing,  and  regulation
          development  support.


          Previous Compliance/  enforcement Strategies

          Pre-1980  Program  Reassessment	

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

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

i              The  1972 amendments to FIFRA 1)  provided  for administrative
!         dvU 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-tiddes 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.  Th« 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
                        from €PA.

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                               - 4 -


     In 1974, EPA entered into pilot cooperative a : - e a -. e ~: : 3 * i t r ^A
5 States.  Prior to this ti.ne, tne States and tna  Faca.-al gjvarn,^^
had separate programs with  little interaction.  7-.e initial emonasis
of the cooperative program was joint enforcement •v:t~  continuec
Federal presence in those States with agreements.

     The Feaeral enforcement program became nore decentralizes i?
February 1375 when Headquarters announced a program to waive con-
currence for routine civil cases, excluding use cases.  3y .November
1978, all Regions were granted 1) full relaxation  of the requirement
for Headquarters concurrence in actions related to stop sales
and civil cases other than misuse cases, and 2) partial relaxation
oT HeaTtqu art firs c-OTrcurrance rn fh-e en for cam en t of  misuse cases.

     The 1978 amendments, under certain circumstances, gave primary
responsibility for use enforcement (primacy) to States.  As more
State programs became operational under cooperative agreements
and received primacy, Federal activities shifted to enforcement
programs in States without cooperative- agreements  and  primacy,
program oversight, training of State personnel, disinfectant/device
tasting, import/export surveillance, and data audits.

     Guidance for the cooperative agreement program was issued
annually.  Until 1930, strategies empnasizaa a graauai shift from
activities related to product compliance to t.iose  non'itoring use.^
Guidance documents assigned percentages to various acti/:tit5
including agricultural, n c n i ~. r • c u 1 ". u r ; 1 a .?•: =*.: e " i 'i e n t i'  ; • »
inspections; producer establishment, marketplace,  import, certified
dpp'.icdccr r e c o r a j inspection:*; d n u rsscr'iwCcu u i c p d j c i c i ^ e ^ c a ', c r
inspections.  The percentages correlated to the amount of total  '
workyears EPA expected the States to spend on the  various activities
Percentages were assigned based on prior violation trends and new
regulatory requirements.

Federal and State Certification and Training

     Prior to FY81, the C & T program was operated by  the Office
of Pesticide Programs (OPP) Independently of the compliance program.

1980 Program Reassessment

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

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

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 o Ensure  tnat  eligiDle  States  receive primacy and adaq-..ata*y
  the  public.  This goal was to oe  acniaved cy :  a) pro-u" :ating an
  interpretive rule on  primacy standards; b) promulgating a regula-
  tion  governing hearings for  rescission of privacy; c) issuing
  guidance on  incentives and sanctions to encourage adequate State
  programs; and d) evaluating  all State use enforcement programs.

 o Ensure  effective compliance  monitoring and enforcement  activities
  by assessing trending programs and revising training materials.

 o Ensure  adequacy of the certification and training program by: a)
  reviewing State plans and certi f i.ca±ion and recerti fi cation proce-
  dures and Extension Service  program materials; and b) revising
  training materials as appropriate.

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

 Implementation of Strategies	
     The Compliance Monitoring Staff designed and began implementing
strategies for achieving ties a goal 3 ii l?3l.  A 3 u-nary -:f t:i = 53
stratagi as fal1ows:

Improve nanajeme.it

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 in conducting FIFRA compliance programs in Colorado,
Nebraska, Wyoming, 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  wtiich 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 Federal- Programs 1n States without Cooperative Agreements.

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     Application of the model results in four products:

1.  A list 3f pesticide use problems ranked by their .-a: it:
    contribution to harm from pesticide use/misuse
2.  A- listing of pesticides ranked by their relative con:ributi :~
    to harm from pesticide ase/nvisuse incidents.

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

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

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

     The FY82 Cooperative Agreement guidance crave general directions
for setting non-use priorities but contained no specific model.
Upon request of the States, such a model was developed for the
FYS-i guidance.  Because narm is likely to be greater for use-ralatea
activities and the compliance rate is generally hign for non-use
related activities, ~~* ranking o r o •: e d 'j r e suggests that 25* of
available inspection .- 3 3 ? 'j.- c e s b a a 1 ; ; c 21 e a to r.jr.-uss relates
activities.  Under the ranking procedures suggested for non-use
pr*cr*t*sj, ii * •"»£ i i d ii C e tiiu /i 11 ij r 'i /i £ priori cy <.» 
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 o  Pesticide  establishment  registration and production -eoorting
 o  Inspections  and sampling
 o  Case  management
 o  Grants  information
 o  Contract inspections

 After a feasibility study  in 1979, a system design phase was
 initiatea in I960.  Development and Implementation was b-egun in
 early 1981,  and by October 1981 FAT£S was operational.  Regional
 system  installation and ussr training was accomplished in 1982,
 and system validation was  completed in 1983.  However, major FATZS
 data base system updates and enhancements are required to maintain
 data for  new program activities such as the FIFRA Child Resistant
 Packaging and  Label Improvement programs, and to provide compretieTi-
 sive information for the Administrator's Management Accountability
 System.   Additional ADP contract, resources are required to provide
 these system enhancements  and to maintain the additional data the
 new programs generate.  When fully operational, FATES should facili-
 tate priority  setting.

 Uni form Standards.  In 1982, an evaluation. protocol was included in
 the FY83  cooperative agreement guidance.  The protocol was developed
 1) to ensure that all State cooperative enforcement and C & T programs
 would be  evaluated, annually by the Regions according to uniform stan-
 dards;  and 2)  to en-sure that appropriate pesticide use problems would
 be addressed in State pesticide applicator training and certiri;a-ion
 materials.  This protocol was developed for a 5 e In ~ Y 3 3 a.~. i -,v • ; ;  D e
 modified  as appropriate based on experience with its use.

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

 Primacy

     At the request of the States, EPA developed a rule interpreting
 several key provisions in  §26 and §27 of FIFRA.  The Interpretive
 Rule promulgated on January 5, 1933 aJ-dreused 1) when a State will
 be deemed to have adequate pesticide use laws and enforcement proce-
 dures,  2) criteria used by EPA to determine whether a State is
 adequately carrying out primacy. 3) EPA procedures for referring
 misuse  allegations to tne State and tracking State responses, 4)
 the meaning of appropriate enforcement action, and 5) factors con-
 stituting an emergency and circumstances under which EPA will defer
 to the  State for enforcement.  Generally, tne Agency determines
 whether a State should be  granted primacy or whether its use program
 Is adequate based on a review of the State's entire program rather
 than a  case by case review.  EPA evaluates a State's primacy program
 during  the end of the year grant review for those States with coopera-
 tive enforcement programs.

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                               - a -


     On May 11, 1981 EPA promulgated a rule (45 FR 25j53v govami
procedures to be followed by the Aaministrator in rescinding
primacy.  Under these procedures, whenever the Administrator makes
a determination that a State is^iot adequately discharging its
use enforcement responsibilities', ne must send a notice to the
State specifying the deficiencies in the State's use enforcement
program.  If after ninety days from receipt of a nstica by a Stata,
the Administrator finds that the otate has not corrected the
deficiencies set forth In the notice,  the Administrator may rescind,
in whole or in part, the Stata'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 resolve the problem prior
to formal rescission procedures.  Generally, few problems have arisen,
and those were satisifactorily resolved.

Trai ni ng/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 through
having experienced EPA pesticide insoectors assist State inspectors
in the field.  In addition the National Enforcement Investigations
Canter (?iEIC), in cooperation with tha Compliance Monitoring Staff
(CMS) and the Regions, conducts us e/mi S'jse investigation wo^snoo'
for Stata pesticide inspectors.  T'nase .vcrk shops cover sta:a oj
the art pesticide drift monitoring technia-jes  and basic use/nisuse
investigation techniques.  The worxsnops induce 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-slte reviews of State pesticide
laboratories to evaluate sufficiency and recommend improvements,
and conducts a check sample quality control program.  These
activities will continue 1n the future.

     To ensure tlrat corap.llance/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 the 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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Certi f1cation and
Training Program

      In FY81, OMB transferred tne program to tne comsli>nce/
enforcement program.  This transfer provided an opportunity to
better  coordinate the two programs.

     FIF3A provides that certification of pesticide applicators
be accomplished under State Certif'c»tion Plans anproved by
EPA with training presided by the State Cooperativ-e Extension
Services (SCES's).  This objective has been largely accomplished.
Only Colorado and Nebraska lack approved certification plans and
only the Colorado* S££S fail.s to provide applicator training.  In
each of these States, EPA has established programs In tne absence
of State activity.

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

     Sased on operational  experience, tne re has been a need for i:me
changes, and  certification plans nave been 2 mended in res pens 2 t:
these needs.

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

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

Additional  Activities - Federal  Program'	

iTtput tnto Development of Me* Regulations

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

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General	

     As mentioned previously, the Federal ro'e srii'taa, as rcc^e
States received grants, to the oversight of the ccooerative program,
enforcement response for State referrals, enforcement programs in
States without cooperative programs or primacy, ana a compliance
monitoring and enforcement program consisting of data audits,
import and export surveillance and efficacy testing.  With the
exception of the data audit program, which is managed at Headquarters,
the Regions have primary responsibility for the Federal Program.
CMS provides guidance documents, policy interpretations, technical
support, and oversight for Regional activities.

Data Audits
     The data audit program for studies submitted in support of
pesticide registration was instituted in 1975 after the Food and
Drug Administration (FDA) found that studies submitted to it had
serious deficiencies.  The strategy has been to audit studies at
pro.blem laboratories, audit studies of special significance to"
regulatory decisions, and conduct routine audits at all pesticide
laboratories.  Under an Interagency Agreement originating in 1973,
FDA conducts inspections at laboratories which conduct haaltn
effect studies.  £°A inspectors primarily conduct audits of environ
mental studies.  EPA scientists participate on audits as aooroo
A Data Audit Panel within Office of Pesticides and Toxic S J b s t a .1 c
(OPTS) targets inspections, reviews reports, and recom-
 : 3 r. „ 3 2 p;
FIFRA Imoort Surveillance
                                     ort provisions of FIFRA is
                                       f..--— e	-'--.  Customs
                                                      roducts
                                                       States.
                                                        Customs
it a peatitiae appears to oe in viuiatiun 01 rirt\M, tne uusuum^
inspector stops the entry of the pesticide Into the Customs
Territory of ttie 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 Ntrtices of Arrival hav« be-en received and 670
inspections of imported products have be«n conducted for the past
few years.
Efficacy Testing
Disinfectant Testing

     The Federal program for disinfectant testing, which is no
longer active, inj/olvexl eff1.ca.cy testing of hospital disinfectant
Sucti testing 1s Important considering that failure of hospital

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 di s i nf set ants can contribute to the incidence of i n* ?--. i ens
 vulnerable patients and result in unnecessary and u r. •;-.:* i ? g ex::su-2
 of  hosoital staff to pathogenic organisms.  0?D's Saltiville
 laboratory formerly performed efficacy testing on aoout 200 sa-ioles
 per  year.  The failure rate ranged from 45% of 111 sa-ales in 1530
 to  72% of 40 samples in 1982.  T.he Beltsville laboratory suspencea
 testing of disinfectants, sanitizsrs, sterilizers, ana ger-nciaes
 in  Octaoer 1932 due to competing higher-priority needs, altnougi
 the  capability to perform such tests remains.  CMS proposed an"
 efficacy testing program for FY85; however, it was not included in
 the  priority listing of.OPTS programs.

 Ultrasonic Device Testing Program

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

Electromagnetic Device  Tasting ?roc ran

     A program similar  to the ultrasonic program was conducted
for  devices which purport to control pests utilizing the principle
 of electromagnetism.  The Bureau of Standards, through an Interagenc
Agreement with CMS, conducted the electronic analysis of  eighteen
 different devices.  University and USDA personnel conducted efficacy
tests on rodents and insects for CMS and determined that  electro-
magnetic devices were Ineffective for these pests.  Appropriate
 regulatory actions were taken by CMS which resulted in the ban of
these types of devices  from the consumer marketplace.
Rodenticide Efficacy Testing
     The Office of Pesticide Programs funded an Interagency Agree-
ment with the Denver Wildlife Research Center in FY83 to conduct
a national prograa to test rodenticides for efficacy.  CMS is
participating 1n tills program by coordinating the sampling,
chemistry testing, efficacy reviews, and enforcement response, if
any, for the rodenticides.

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                               - 12 -

Monitoring of radars'! Ssray Programs	

     Ths EPA through tne Federal enforcement program or :.-.e
cooperative State programs routinely monitors spray pr^raas
funded by Federal agencies.  For instance, application 5~3y
for-hirs applicators during the Grasshopper Control Program nav»
been monitored by the States of New Mexico, Texas, and Oklahoma,
and by EPA in Nebraska and Colorado.  The E?A and tne States
may also conduct use investigations for smaller scale programs
Including aquatic weed control, forest p-est control,  and pre-
dator control programs.
Present State of compliance	

Regulated Community	

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

o Number of Registarad Establishments                     1-1,000

o Number of Applicators Trained and Certified

  Private                                              1,500,000
  Commercial                                          -   496,000

o Numsar of Laboratories Conducting FIFKA Studies            -03

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

o Number of Export Notices received annually (approximate)    75

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

o Number of §18 Exemptions issued in 1932          *         373

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

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

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                               - 13 -

InsDecticns and Actions
     The shift from a Federal  to a  State  program has  resj'ted  i-  an
increased number of inspections and increased  field  orasence.   ;
complete data oase on enforcement actions wnich  induces  State
activities only exists for FY31 and FY82.  In  FY31,  a  total  of
50,104- State inspections was conducted.   The  percen-  of  insoections
resulting in action was 17.4.   In FY32,  a total  of  59,317 State
inspections was conducted.  The percent  insoections  resulting  in
actions was 13.1.  Violations  figures for specific  types  of
inspections indicate a higher  rate  of noncompliar.ee  ~'ir  use  related
requirements than for non-use  related requirements.

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

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

GoaIs ana Priorities

Long Term Goals

     Long term goals for the FIFRA  Compliance/Enforcement Program
are listed in order of priority below:

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

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

Near Term Priorities

     Priorities for the FIFRA compliance/enforcement program through
FY85 fall into the following management,  compliance monitoring
enforcement respons-e and certification areas:

Management
o Write FY85 Cooperative Agreement Guidance.
o Develop formal procedure for and provide support to OP? for most
  new regulations, suspensions/cancellations and other actions tor
  ensure that the documents are enforceable.  In order to do this
  effectively, it is mandatory that compliance/enforcement program
  staff be involved early in the development of such documents.
  This has oeen a problem in the past.  Therefore, a forma'  system1
  of communication between OPP, Office of General  Counsel, anc CMS
  should be developed.
o Finalize strategy for conducting data audits and Good Laboratory
  Practices (GLP) inspections.
o Finalize enforcement response policy for data audits/GLP
  inspections.
o Develop compliance monitoring strategies and enforcement response
  policies for most new regulations and suspensions, as appropriate.
o Ensure that all States and Regions conducting Federal
  enforcement programs have fully implemented the  most effec-
  tive/flexible system for allocating resources to priority
  pesticide problems.
o Provide technical and legal support to State*
o Provide training for State Inspectors and chemists.
o Prepare additional policies for the FIFRA Policy Compendium, as
  needed.
o Promulgate final FIFRA §4 rule requiring dealers to keep records
  of their restricted use pesticide sales and clarifying where
  commercial applicators must keep their records on their applica-
  tions of restricted use pesticides.

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                               -  15 -

Compliance Monitoring	

     Program  guidance  indicates tnat generally 75"  c-  ; -:: •= ;t •> :-:
resources should be directed at use proble-ns and 23*  at  :-:cuct
related priority problems.  The priority setting g'ji:2."!ce ;3 desi
to be flexible, allowing a shift  in inspection targets -rorn year to
year based sn shifts in State specific problems ana new  rI-3A
regulati ons.

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

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

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

o Violations 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.
o Submission of false data to EPA in conjunction with ?eit::;.:a
  regi strati on.
o Sale of Restricted Use Pesticides to uncertified applicators in
  Statas with Federal  Programs.
o Label or formulation violations likely to result in harm to
  health or the environment.
o Violations of Child Resistant Packaging regulation.
o Pesticide enforcement registration and reporting violations.

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

Plans for Achieving Program Goals

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

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Comoliance Monitorina Plan
Objecti ves
     The basic objectives of the compliance monitoring clan ire:
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 compliance oy
the regulated community (FATES) and to use this information to
identify persons likely to be in noncompliance; and 4) to discover
problem areas requiring resolution through re-gulatory initiatives
by OPP.

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

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

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

     On-site inspections are the major method through which E?A
monitors compliance witi. 7TF3A.  Ti'.cas i "spacii c~; i"3 csnijcts.!
1n response to complaints and on the basis of target selection
under a neutral administrative inspection scheme (NAIS).

Inspections Based on Referrals/Complaints

     Both the Agency and the States place a high priority on
response to complaints or referrals regarding violations.
Referrals, tips, and complaints are particularly important to
EPA compliance monitoring for misuse.  This is because FIFRA §9
gives "EPA 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 1s occurring.
Probable cause can be based upon a detailed allegation from a
reliable source Hnfc-fng specific action with a specific misuse.

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

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                               -  17  -
     Misuse  is difficult to detect unless an inspect:"  • 3 o • -e s e n t
during  actual use or soon a.rter t.ie use of the pest^;:^=.   ~-iere-
fore, use inspections are conducted in resoonsa to a ::-.^", »:nt
referral or  during tne actual application of tha q-JSf'f'-e.  -eci-
timate  compl ai nts/referral 3 regarding pesticide rnsuse  ^ay  32
ineffective  if tney are-not made and investigated oromotly  oecause
tne evidence, especially in the case of highly totic organoonosonates
will no longer be there at tiie time of tne investigation.

     Even if there were no limitations on entry authority,  evidence
of pesticide misuse may be difficult to detect during a planned use
observation.  Because inspectors would not generally otherwise know
when and wtiera 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 Inspections
     EPA and the States can use on-sita 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-el-ea, or whether scientific
data submitted in support of a pesticide registrati on correctly
reflects the testing which -.fas conducted and trse results.

     Since most States have regulations requiring dealers of
Slip's to keep records of Cfieir aa'ies, i: is rel at i «c"i> ejj>  "or
States to determine whether the requirement is being met.  In
addition States can follow-up the records and inspect the applicator
to determine whether he is certified.  Based on records which
commercial applicators are required to keep, it-is often possible
for the States to determine whether the RUP was used'in accordance
with its label instructions.

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

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                               -  1 8  -

Ta rgett1ng	

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

     The  current  use/misuse priority setting system  is based-
primarily on data  in  case  files and  incident files.   It  thus
yields priorities  which  are responsive  to  previously  existing
problems  which posed  actual harm.  This  system should  be  com-
plemented by one  aimed at  predicting potent i a 1  f or  ha rm  based
on trends in the  quantities and types  of pesti ci des  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
Uithin the Agency	

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

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                                           - 19 -


            Expand Referral Systems
            With Other Agencies	

                 While the Agency has referral  systems  fo." specific tyoas  of
            products or violations witn FDA, Consumer Product Safety Commissio-
            (CPSC),  Occupational  Safety and Health Administration (QSHA),  ana'
i            Federal  Trade Commission (FTC), it  should expand the systems.   EPA
i            should encourage States to set up similar systems.

            Improve  Referral System
            Retween  the Regions and States
i                           	
;                 FJFRA §27 requires EPA to refer all  significant allegations
I            of pesticide misuse to the States.   The Interpretive rule provides
'.            specific procedures for the referral  and  tracking of such cases.
!            Although all Regions  have implemented informal referral  and  trackin
:            systems, some systems are better developed  than  others.   All the
i      •      Regions  need to implement a formal  system.

            Expand Work with the  Press
            and Special Interest  Groups

                 Botn EPA and the States periodically encourage  the  national
            and local trade press to write articles on  new and  existing  pesti-
            cide control '•equi rements.  Knowledge of  FIF3A and  State pestici-e
            I j'.vs have consistently resulted in  discovery  of  violations  of  both
            laws.  Because evidence of pesticide  misuse'may  rapidly  disappear,
            ic is  particularly  important that EPA and the S:dtes expand  :.-si'r
 ;           efforts  to work with  such groups as  farmworkers  to educate  them
            about  basic evidentiary requirements  and  the  'need to contact the
            government as soon  as possible after  occurrence  of the  alleged
            misuse.   Efforts made in this  area  continue to be restricted by
 •           resource levels.  CMS has issued a  Complaint  Form, which was
            sent out as an update to the FIFRA  Inspection Manual, to facilitate
 j           the reporting of complaints or referrals.

 '           Integration of Inspections	

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

 i              EPA will also  continue its program of  integrating FTFRA and
 j          TSCA data audit/laboratory inspections.

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

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                               - 20 -

away from requiring a specific frequency in its guidance.  ".•.3:32:,
trie Agency suggests that frequency oe estaoiisned tire;::"1 : ne
priority setting system.  This is true for misuse as *e'! 2i
establishment inspections.

     Laboratories are expected fo oe inspected under -.-:e data aucit/
laboratory inspection program every 2-3 years.

    Inspections at device producing establishments should be oart
of the routine inspections of establishments manufacturing general
use pesticides.  When the Agency is conducting a major testing
program for specific devices, samples are collected at Headquarters'
request or in response to complaints.  Types of devices for which
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 separate program for disinfectants.

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

Follow-uc Insoections
     Follow-up inspections are conducted when more informati
is needed for a possible enforcement case or when violations
h2Y2 been fo'j~i i?d the R'^iorv'State d°te''**?'' ?°s t^'t aiT*hai"
inspection is necessary in order to assure compliance.  The
frequency is determined on a case-by-case basis depending on
the need for a follow-up inspection to assure compliance.

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

     In addition to providing training and basic guidance, EPA
reviews State inspection reports to ensure that inspections are
conducted properly, appropriate inspection procedures are followed,
and sufficient evidence is collected to support enforcement actions.
This review 1s normally conducted as part of EPA's routine oversight
of the cooperative prog-raw during raid-year and end-of-year reviews.
T-his revvew activity *M 11 continue.

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      In accordance with the Agency's Quality Assjranca ' I; ;  require
ments, States receiving grant money through tne coooerative  enforce
ment  p'rogram must develop QA Plans covering botn corns 1 i d" ce  ;ncn i - or-:
and sample analysis.  These QA Plans must be submittec to tne .^egio
Quality Assurance Officers annually for review and apsroval.  Tne
Compliance Monitoring Staff, with the approval of the EPA Quality
Assurance Management Staff of ORD, has provided guidance  to  the
S-egions and States on the development of QA Plans.

Compliance Promotion Plans

Objecti ve	
     Compliance promotion is an important component of any
successful compliance program.  The objective of compliance pro-
motion 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 ta
inspect every member of the community regulated under FIFRA, both
must depend largely on voluntary compliance.

Tools
     EPA and the States promote voluntary compliance wi
through tne following mechanisms.

Educational Proarams
Certification and Training.  Perhaps the most widespread compliance
promotion tool is tne pestici de 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 others) are  not
only aware of pesticide use requirements and generally competent
to apply pesticides but competent in particular to apply restricted
use pesticides.  Training materials are frequently revised,  and
EPA will issue further guidance in FY85 directing that information
from the priority setting process be Incorporated into certification
and training materials and examinations as appropriate.  Implemen-
tation of this guidance will be dependent on available resources.

Other education programs.  These programs are designed to promote
safe pesticide use.  An example is Project SAFE,  which is sponsored
by the National Aerial Applicators Association and the Extension
Service and is supported 1n part through cooperative agreement funds
During the first phase of project SAFE, trainers  were trained  to

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                             - 22 -


conduct fly-ins' to teacn aerial  applicators better ca'::-it::-
techniques to minimize pesticide  drift and to obtain octi.^a'  pss:
control with the minimum amount of pesticide.  The" r.ava ree'1
three trainer fly-ins which involved approximately  -3 States.
During the next phase of the program, these trained specialists,
mostly cooperative extension staff, will  be conducting fly-ins for
aerial applicators in their States to help the applicators calibrate
and apply pesticides in the most  environmentally effective manner.

Farmworkers Program

     Several ye-ar« *go, tke Agency initiated a .pro-gram to ev.aljj.atj3
the specific problems of pesticide misuse related to farmworkers,
especially the migrant farmworker.

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

     Language for ase on outdoor  ajri ;-!tjral prcd-ct3 tc ~3rt
the standards is being developed  under OPP's Label Improvement
Program.  OPP is also considering a dual  language requirement,
English and Spanish, for highly toxic products labeled for agricul
tural use to help assure compliance.

     The Agency continues to hold meeting with farmworker groups
to discuss farmworker problems and seek solutions.  CMS included
in the annual cooperative enforcement agreement guidance a request
that States consider Farmworker exposu-e  in setting priorities.

Publications

Compliance Policy Compendium.  The Agency has developed and will
continue to expand its compendium of FIFRA Compliance  Policies,
These policies Interpreting compliance requirements are available
to the regulated community as well as the Regions and  the  States.
   *
    Fly-1ns are programs in which aerial  applicators actually  fly
their airplanes to the training- site.   They then fly over a
designated area and apply water containing a dye.  The  spray
pattern 1s titen

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                                -  23  -

Suspended  and Cancelled  Pesticides Booklet.   This  boc.s'et  *is  '"'-st
prepared  by  CMS  in  1977.   It  was  compiled  to  suma-i za  i~:  :lir--"y
Agency  actions on pestici-as  which nave  been  suspend:,  t'i.ica! 1 ec",
or  otherwise  restricted.   It  was  designed  as  a  ;'ji-t<  re'e-a^ca  r:--:a
for use by pesticide  inspectors but  is available to  fa  c-bl'-t.

Publication  of Results of  Major Testing  Programs.   In Octooer  133C,
CMS issued a  puolication called ihe_Investigat1on  or  Efficacy  anc
Enforcement  Activities Pel, at Ing to elect re lacr't::  ?a5t  Control
Devi ces"   rhe results of the  ultrasonic  testing program  will also
be  published  in  the future.   These types of publications  ara useful
to  other  Federal regulatory  agencies, consumer  groups,  foreign •
•countries, prospective producers  of  such devices,  and to  the public.

Notices of Judgment.  Under Section  16(d)  of  FTF3A, EPA  p-jblisnes
enforcement  act.ions taken  against violators.   It is  believed tnat
the Notices  of Judgment  have  some deterrent effect.

Press Releases.  Thssa ara ganarally issued when major  violations
occur or  if  puolic  attention  has  basn focusad on. a  casa.     • *

'Perso.nal  Contacts

Compliance Inspections.  Discussions of  regulatory  requirements
during  inspections  a", so  provide a system for  educating  t.ie  reguiatec
community  concerning  saectfic FIFSA -reqiii renents and  tne  rae1:  to
comply.      •                         •           .•  '
participate  in  pa-e1  i: icus:: :rs  zt  -r.ius       -   --

Pub!ic Presentations.  EPA personnel give presentations and
p 2"t i tl pata in p a.? a1  i: i t -
and other public meetings.

Noncompllance Response Plan
   s  The objectives of  a  program for  responding to instances of
 noncorapHance  are  1) to ensure that violations and resulting pro-
 blems  are promptly corrected; 2) to quickly and effectively take
 equitable enforcement action  against  violators; and  3) to deter
 similar noncompl1anca In  the  future.

     A broad range of enforcement  responses 1s available under
 FIFRA. Including advertisement letters  (I.e., letters to registrants
 regarding advertising claims), warning  letters, stop sale, use and
 removal orders,  request for voluntary recalls, seizure, Injunctions,
 administrative  civil penalties, criminal penalties,  suspension or
 revocation  of  certification,  refusal  to accept data  from labs
 refusing inspection, suspension/cancellation of the  registration.
 and revocation  of the establishment number.

     Detailed  guidance  for selecting  the appropriate response is
 available to the Regions  and  States in  the 1983 FIFRA Compliance/
 Enforcement Guidance Manual and 1n the  Civil Penalty Policies
 listed on page 25 under the Administrative Civil Actions Section.
 Inspections will continue to  be conducted with increased frequency
 at those establishments with  a violation history.

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                            - 2* -
     States also have a broad range of enforcement
including fines, revocation of licenses .and permits.  'J-:;- I?Vs
interpretive rule for primacy, c?A considers a State's i::':n
to be adequate if the State takes tie most stringent j::^- avail-
able which is comparable to the available FIFRA response.

     A description of the FIF3A enforcement responses foMows:'

Advertising letters	

     An advertising letter is a letter issued by EPA as notice
to the company that collateral literature concerning a product
(i.e., literature or advertising that does not accompany the
product) bears unacceptable pesticide statements or pesticide
or d-evice xl.ai.ms-  Ttxe letter may be issued on receipt of or
knowledge of such literature.  The letter requests a written
response from the recipient informing the Agency of what action
the company plans to take to correct the situation.  Receipt of an
advertising letter does not mean the recipient has been- found in
violation.
                                                             *.
Notices of Warning - FIFRA §9(c)(3) or SU(a)(2)            -*

     For minor violations, a written Notice of Warning may be issued.
Also, Notices of Warning are issued for first time violators which
are private applicators or other persons not covered by Section }-{i]
(1).  Section l*(a)(l) covers registrants, commercial applicators,
for hire applicators, wholesalers, dealers, retailers, !•">•: srne'-
di stri butors .                                                 •

Notices 3f Dats't* :*: - -!f?.A **"*    	

     Section 17 authorizes EPA to refuse admission of a pesticide
or device being imported Into the United States if EPA determines
that such pesticide or device violates any provisions of the Act.
This refusal is known as a Notice of Detention and Hearing.

Stop Sale. Use, or Removal Order - FIFRA 513	

     The Administrator may Issue a Stop Sale, Use, or Removal  Order
(SSURO) when: 1) based on Inspection or tests, there is reason to
believe thxt a pesticide or device 1s in violation of the Act or
will be sold or distributed in violation of the Act, or 2) the regis-
tration of a. pesticide has been cancelled or suspended.

Request for Voluntary Recall	____

     No expUct authority exists 1n FIFRA for the recall of pro-
ducts.  The effectiveness of a recall action depends on the
cooperation of the Involved company.  Recalls are considered for
products which are likely to result in adverse effects to the
user or environment, physical or economic Injury due to ineffec-
tiveness or presence of residues.  There are two types of recalls
foraal and Informal.  The level of recall also varies, I.e.,
wholesale point of distribution, retail, or user level.  The scope
•ay also vary, e.g.. one batch or all of the product.

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                               - 25 -


Seizure - FIF3A SI 3	

     Section 13(b)  gives £?A tne authority to initiate in rgm
condemnation proceedings in district court.  Seizure :s generally
used if a Stoo Sale,  Use, or Removal Order is not being obeyed,
or for extremely hazardous pesticides that require removal  from
tne marketplace or  place of use, or if a' company does not comply
with .a Recall Request, or to dispose of products being held unce-
a Stop Sale, Use, or  Removal Order, if appropriate.

Injunctions - FIFRA §16(4)	

     EPA has fie authority to Initiate injunctive actions before
district courts.  This is to be used 1) when all other remedies
would be inadequate to restrain a violation or to prevent unrea-
sonable risic, 2) all  other remedies have been used but the  vio-
lation continues, or  3) irreparable injury, loss, or damage will
result If relief is not granted.                              „
                                                             •  s
Penalties - FIFRA §14(a) and (b)	

     Any registrant,  commercial applicator, wholesaler, dealer,
re.tailer, or other  distributor who violates any provision of
tne Act may be assessed a civil penalty of up to 55,000 per
offense.  Should any  of the above-mentioned parties 'Knowingly
or willfully vidla-te  tne Act, a criminal p3-ial:y of '.ip to §25,000
ani/or imprisonment for up to one year may 5s :^oos*1.  A 3'v-
vate applicator or  other person not included above who violates
the Ait aftar receiving a *ar.v!r.s l-ettsr or cl ;i:; cr, for a  pri:,-
violation may receive a 51,000 civil penalty for each subsequent
offense.  "For hire"  applicators may be fined S500 for the  first
offense and $1,000  for each subsequent offense.  Criminal penalties
for private applicators and "for hire" applicators may be a fine
of "up to $1,000, 30 days' imprisonment, or both.

     Civil  Penalties  are Issued by the Agency and criminal  cases
are handled by the  Department of Justice.

Civil Administrative  Penalties - FIFRA §14(a)

     A civil penalty, as authorized by FIFRA §14(a), is the remedy
of choice for most  violations.  Figure 1 in the Appendix contains
a  flow chart for FIFRA cases.  A civil penalty should be proposed
where-'"the violation presents (a real but not an extreme and unreason-
able) risk to humans  or the environment; 1s likely to be an isolated
occurrence; was apparently committed as a  result of ordinary negli-
gence*- inadvertence,  or mistake; and either:

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                                -  26  -


 a  Involves  a  first  offense  under  the Act  by  any  registrar;:,
   commercial  applicator,  "for  hire'1  aaolicator,  wnoiesa'a.-,
   dealer,  retailer,  or  other distributor  (no  prior  waning
   is -required  by  FIFRA  for  violators in this  category);  or

 o  Involves  a  private  appl i cator'or other  person,  other  than
   any  party specified  in  the first category,  who  has  received
   a prior  warning or  citation  for a  violation  of  FIF3A.   (The
   prior warning or  cltat'ion may nave ieen  for  tiie same  or a
   different FIFRA violation.)

     Under FIFRA  §14,  the Agency  may issue  administrative'
 civil  complaints  to  persons who violate FIFRA  §12.  The  Agency
 •rnurt e-strtllsh by proper -evidence each element  of the violation
 charged.   Generally,  the Region issues the  Civil  Complaint.   (The
 Regional Administrator  is delegated  the authority to  issue
 administrative complaints and  negotiate and  sign  consent  agree-
 ments) .
                                                             K
     The fol low-ing  factors  are used  to determine  the  penalty *
 amount: 1)  the size  of  the  business  of the  person charged, 2)
 the effect on  the defendant's  ability to  continue in  business,
 and 3) the gravity  or  the violation.  The  penalty assessment  system
 initially  determines  a  penalty amount based  on  the  nature and extent
 of violation  and  then  adjusts  this amount  in  consideration of
 mitigating or  exacerbating  factors.  Th-e  guidelines for  assessing
 civil  penalties are  proviaed in the  following  documents:

 o  Guidelines  for  Assessing  Civil  Penalties  Under  Section  14(a)
   and  Citation Cwarges  *or  Viol at4 o^s of  FIF'.A  '-jubl i sn
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                                - 27 -


         Proceed"! ngs  - FIF3A  §!•*!)
     The Agency may  initiate  criminal  proceedings  in  eva.-y  :as-»  :n
which £?A can meet the stringent-  requirements  of  evidence  *r,*  p-oc-
leading to  a conviction.  However, Agency  polity,  as  well  as 3-2:-
matic resource considerations, argue against the  use  of  crimiiil"
sanctions in any but the most  serious  instances of  environmental
misconduct, as determined by the  nature  of tne  violation,  tne  .1: story
of compliance on t.ie part af  the  responsible person,  or  the  s.erious.ie
of the environmental consequences.

     Criminal action 1s appropriate for  knowing and willful  violation:
which actually or potentially  result In  serious harm  £o  health or the
environment.  EPA will follow  the guidance contained  in  the  Criminal
Enforcement Priorities 'for the Agency  set  forth in  Robert  E. Perry's
memorandum  :f October 12, 1982.   EPA will  identify  cases for crim'inal
action as early in the case development  process as  possible  to ensure
that the potential defendant's rights  are  protected and  to  ensure :.Hs
integrity of the criminal enforcement  process.  When  a Regton  receives
information indicating potential  criminal  activity, it wilixrefer
the matter to the Criminal Enforcement Division at  Headquarters  for
further i nvestigation and prosecution.

Use of Criminal Proceedings

     T .T 5 A g e n cy has  identified a  nj n b e r  of s o e c i f i c s i t •-' a t* : .1 3
for which criminal orosecut i on is particularly  aoprooriate.  ~i
list ti"2se  situations, however, should ?ot ^e  viewed  as  pre-
cluding criminal prosecuti on.  in circumstances  not  included  below:

o Failure to report  Information on the unreasonable .adverse
  effects of a register*: pesticide;
o Falsification of records;
o Violation of an order suspe-^ng or  cancelling  a product
v  registration;
6 Violation of an SSURO;.
o Unlawful  uses of pesticides; and
o Illegal distribution of unregistered pesticides.

Denials, Suspensions, Modifications, or  Revocations
.  of Applicator Certification

     The regulations relating  to  the certification  of pesticide
applicators (40 CFR  Part 171)  authorize  EPA to  deny,  suspend,
modify, or  revoke Federally Issued applicator  certifications
if the certificate holder violates FIFRA or Its regulations.   EPA
considers this a strong measure,  to be taken only  when public
health-, Interest-- or  welfare warrants Immediate  action.  Therefore,
EPA will deny, suspend, modify, or revoke  a certification  only in
response to serious  violations or against persons  with a history
of no-n compliance.

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                               - 28 -
Refusal to Acceat Cata f-om Laboratories Refusing
                                                        -
     This policy is statad in the final FIFRA Good laboratory
Practice Regulations (GLP's) which are to be prorrrj ' ;a :aa in FY'3-i.

Siisoensi on/Cancel lati on of Reaistration
     This is an action xnich may be considered if the statement
of compliance or noncompliance with the GLP's that is to be
submitted along with any data under FIFRA §3 is falsified.  This
action 1s discussed in the  final FIFRA GLP's.

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

Federal  Facilities	

     Generally, if Fadaral  Agencies are fsuni :.? ' vi :1 »v en of -'•
the EPA does not issue penalties.  This is in accordance with Exe
Order 12088, Federal Comoliance With Pollution Control  Standarss,
which established a government wide program for ensuring Federal
facility ..compliance, with pollutl on''control requirements.  Instead of
assessing penalties, EPA tries to resolve the problem.   First, a
l^otice of Warning is issued to notify facility managers of violations,
aqd the EPA works with the  violative agency to establish a remedial
plan.  If the problem cannot be resolved between agencies, the matter
is referred to OMB.

     With regard to criminal action, the Department  of  Justice
has indicated 1t would not  allow EPA to file suit against another
Executive Agency.  In FY 1983, EPA Issued a warning  l«tter to the
F1sh and Wildlife Service for failure to comply with the pro-
visions of an EUP.

     The EPA Office of Federal Activities has developed-a Federal
Facilities Compliance Program Strategy which outlines how EPA
Headquarters and Regional offices will handle Federal facility
compliance activities.  This strategy covers:

o  Tee-nfil ca 1 Ass1 st a n ce - to ensure cost effect1v« and  timely
   compliance.

o  Compliance Monitoring - to -monitor actual compliance.
         *
o  Fiscal Planning Assistance - to assist OMB 1n evaluating budget
   "raquest* Tir ?».-£.» to ccsply with pollution csirtrcl  rsqyl rers
   and monitor use of funds.

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                               - 29 -

o  Resolution of Npn-Como1iance Disputes - to notify *>:- :•'•:_.•
   managers of violations ana estao 11 sn renedi a 1 plais.

o  Exemoti ons - to advise' the President,' through O.V3 ,  'ct -a sera:
   Agency FeTonrmendati ons for exemptions'.

He a d g u a rt e r s / R e a. i o n a 1  Coordination 	

     To ensure implementation of the  nations' -'.-t.- coc-lfance/
enforcement strategy,  Headquarters and the Regions will communicata
through the following  mechanisms:

o Policy and Guidance  documents
o Reporting and tracking ttrrougn FATES
o Technical assistance and  review for inspections and  casework
o Evaluation of State  and Regional Programs

The following is a brief discussion of each of these mechanisms.
                                                             \
Policy and Guidance Documents	                        .  s
                                                       *
 . :   Policy and guidance documents currently exist for all  phases
of the program.  These documents will  be revised and supplemented
as necessary.  Plans for revisions and new guidance are discussed
on page 37.  Both  Regions and States  will continue to  be included
in the review of all major  policy and guidance documents.

Reporting and Tracking
     7^a FATES systam iascri iai pra ,-i j-sly is an in:agral ::o" fjr
inspection targetting program evaluation, responses to the Hill,
OMB, and budget development.   Headquarters plans to revise the
FIFRA §7 establishment registration rule and report form to improve
the usefulness- of data in the system.

Technical Assistance
     Headquarters will continue to provide the Regions guidance in
performing Inspections and developing cases.  CMS will also continue
to- coordinate technical assistance for the Regions through NEIC.
Evaluation
     Headquarters will continue to advise the Regions regarding the
effectiveness of their Federal programs and oversight of State
programs through the Regional Reviews and through written and verbal
communication with the CMS.

Federal/State- Re-Tat1onshi p	

     Most .St-atss sou Itavfi entered into cospfirative .agreements with
EPA for compliance/enforcement and C i T programs.  However, EPA
st111 retains distinct rtsponsltoi Htles under both programs.  Ttve
relationship under the C & T program is discussed on page 32.

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                               - 30 -
                                  i


Cooperative Enforcement Program

     As the cooperative enforcement program has avol •/?•:, .:?e S.
with agreements have accepted increasing responsiblity  2nd now
fully in all phasas of the program *i:h EPA.

Comoli a nee/Enforcement Acti viti es
     The States with cooperative agreements conduct all FIFRA
compliance monitoring activities related to pesticide production
sale and use.  Federal  Inspections are limited to those related to
data audit, Imports, and assistance upon State request in major
spray programs in the Stat«.  (Th-es-e major spray programs are
usually funded by Federal agencies.) In addition, EPA through'
NEIC provides technical assistance including:

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

     Under the terms of the cooperative agreements, States will
take all enforcement actions on violations of only State law and
will re^er all violation* of only Federal law product and establish-
ment registration requirements to EPA for enforcement action.
Where tnere is a violation of both State and Federal law, a Stat*1
may take enforcement action itself or refer the case to EPA if it
is unwilling :r unable to do so.

     All States with cooperative agreements also have primary
use enforcement responsibility (primacy).  Under the terms of FIFRA
§526 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.

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

Program Guidance and
Compl1 ance/Enforcement Priorities

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

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                               - 31 -
tneir own annual program priorities.  Specific outputs  : ; " c:~-
pliance/ enforcement activities are negotiate*! on t-e  ? j : : 3  of  tie
State priorities and productivity factors in tne  guica-'-cs.

Program Evaluation

     Major elements of the Regional evaluation of State  programs
i ncl ude :

o Semiannual reports by the States of their accomplishments  compared
  to the  types and numbers of inspections projected in  the  grant
  agreement .

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

o Training and close informal review of the quality of  State  •
  activities.

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

Feceral  Program in Non -Co opera ti ve Agreement 'States

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

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

Cooperative Certification and Training Program

Certification and Training Activities

     Currently all States but two have approved  and operating State
pesticide applicator certification plans.  All States with the
exception of Colorado  have applicator training programs  administered
by their  State Cooperative Extension Service in  accordance with
FIFRA §23.  Ten Indian tribes have received EPA  funds to develop
Certification Program*,  Under rh» C 4 T  program, over  1.6 million
private  applicators and 496,000 commercial applicators  have been
certified and trained.  As of September 1982,  there were over
600,000 private applicators and over 266,000 commercial  applicators
recertified.

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                               - 32 -


     EPA will ccntinue to conduct  cart 1*1 cation  ?r~--i-i  •?  5t;t
without ca "ti •": cati on plans.  3cth  EPA  and 3:at23  ^ :c=-.i  :-aini-^
material and information to ensure  trtat applicators  : —  a.vare  o"'
changing technology.  EPA and States will  continue  ~:  certify  ne*
app1i cators.

Program Guidance  and C & T Priorities

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

     In response  to  the recent GAO  report, EPA intends:   1)  to
ensure that  enforcement problems identified in the  oriority  setting
process are  addressed as appropriate in certification  and training
materials; 2) to  ensure t.*:at Stata  programs require  applicators  t:
meet  Federal standards of competency; and  3) to  review  and  revise
training materials as appropriate.

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

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

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

Coordination  with Enforcement	
     Stronger emphasis will  be placed on transferring Information
from the enforcement priority setting process to the  certification
and train-frig program for Inclusion in training and certification
aa-tartaLs.  T.o Accomplish this. EPA will include in Its  annual
Cooperative Agreement Guidance a request that States  establish
a management mechanism which will assure that information on
priority pesticide problems  *re Included in the State's  certifi-
cation and training programs, as appropriate.

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                               - 33 -

 Update  of V 21 e r i a 1 s

     The core manual and various ca:agory manuals *e"s racantlv
 updated to reflect changing needs and technology.  Co::as of cine
 manuals will se printed by the State Cooperative Extension Services
 (SCES).  These and other training materials will 3e cataloged at
 the USDA 3eltsville library using EPA funding.  T'->e problem continues
 to be future availability of copies.  Neither the Government Print:-^
 Office  or the Department of Commerce will maintain copies of these
 publications for distribution and sale.  Therefore, while copies
 can be  reviewed at the Beltsville library, a user can only print
 his own copies from a camera ready copy, or if the timing is correct,
 order from a SCES which is aioojt tja make a printing run.   SCES's
 do not  usually maintain an inventory of copies for sale.   Therefore,
 the problem is not so much updating training material, but making
 it available when requested to groups other than the SCES's.

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

Review Plans

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

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

Federal Facilities	
       Federal agencies can have their employees certified under
State or EPA administered certification programs.  Most  Federal
agencies chose this option, even though it imposes geographic
limitations am w.ti«re tfce applicator can apply pesticides,  I.e.,
the State Issuing the certificate or States with reciprocal
agreements.  However, because some Federal applicators must  work
1ft several States* often on stiort notice, EPA allows Federal

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                                         -  34  -
          agencies  to  develop  certification  plans  for their e-so/eas.
          Applicators  certified  under  Federal  agency plans can  irciy
          pesticides  anywhere,  but this  certification is  limite*:  :o official
          auty  functions.  To  date, three Federal  agencies, 003,  USOA anc
          DOI,  have  approved Federal agency  certification plans.
          Cross  Program  Elements
               The  pesticide  program  impacts  regulations  and  enforcement of
          other State  and  Federal  environmental  statutes.  There  is  a need
I          to  1)  establish  a better and  more formal  referral program, and 2)
          to  develop a  mechanism  to educate inspectors  on  the  various pro-
i          gram  r*equir«m€nts in order  for them to effectively  make  referrals
          to  other  programs.
|
:          I ntraAgency _
         Toxic  Substances Control Act  (TSCA)

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

         PCS's  (Polychlgrinated Biphenyls)  in Pesticides.   Use  of oil con-
         taining  any  ?C3's  as  a pesticide carrier  has  b~e~e n  prohibited under
         TSCA.  Additional  TSCA regulation  of chemicals may  Have a  sini
         impact on pesticide  registration and use  which require monito"
         under  both Acts.
              icide  Precursor?  and  Intermediates.  Hazardous pesticide ore-
          cursors, and  intermediates wnich are not directly regulated under
          FIFRA  are  regulated under TSCA.

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

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

-------
                                - 35 -
 Hazardous  'Vast a  Program

      Pesticides  are  a major constituent of the -vai:2S at a large
 number  of  hazardous  waste sites and information on registrants
 and producers is  needed for clean-up cost recovery and associate
 enforcement actions.' Information on oesticide manufacturers .113
 been  provided to  the Office of Waste Programs in-'orcament as part
 of the  Agency's  dioxin monitoring orogram.

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

 Water Program

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

 I nterAgeney
Data Audits/Good Laboratory
Practice Inspections

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

Soray Programs

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

Efficacy Testing

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

-------
                               - JO -
     EPA worxs witn other "ede.-al Agencies of tne'~ ~2juest :i
the aeve; opinent and implementation of C i 7 prp^rans.   Currently
DOD, USDA, and DOI's Sureau of "Land Management nave approved C *J *
programs.

Food C :.-rt2,r1 iat i an

     USDA  an-d FDA monitor pesticide residues in food.   3otn
agencies forward reports on food contamination oy pesticides
to EPA for followup investigation, if appropriate.

Referrals  and Information Exchange

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

Program Eva 1uation

     A system for evaluating the effectiveness of the  FIFRA com-
pliance/enforcement program must define specific areas for evaluatio
measures of program success and mechanisms for performing the
evaluation.  The Agency can best measure its success in achievi^
compliance whan it has developed i) an adequate aata oasa for
identifying members of the regulated community and 2}  predict:
models designed to select those -nenoers most likely to be in
At that stage, the Agency can consider its program a succass if only
13i of those persons inspected under a neutral scheme  are violators
•% ~ ? T ? O ^
^ •  i • • . * .~\ «

Evaluation Areas

     Areas for evaluation include 1} adherence by EPA  and the
States to  quantitative and qualitative performance commitments; and
2) the extent of compliance with FIFflA by the regulated community.

Measures of Success

Adherence  to Commitment

     The adherence by EPA and the States to performance commitments
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 actions
o Accuracy and timeliness of compliance data entry and retrieval^

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

-------
                                          -  J /  -

           Compliance  by  the  Regulated  Community	

                The  axtant  of conp':aica  for  tia  '•agu'atec  :: --rj -i: :/  -iay 33
           •neasured  to a  limited  degree  by tie  fallowing  fact o-s:

           o  Number  of applicators  trained and  certified.
           o  Proportionate  number of  estaolisnments  known  to  2e  in  como'iince.
           o  Proportionate  nunoer of  applicators  known  to  oe  in  corco1ianca.
           o  Proportionate  number of  laboratories  known to  ae in  compliance.
           o  Trends  in major  types  of  violations.

           Evaluation  Mechanisms	___

                Th-e  awjor mechanisms  to  txe used in program  evaluation  are
           the  following:

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

           o  Mid-year  and and of  year  Stats  program  reviews.  As  discussed
             on  page 31,  these  reviews/evaluations are  bases  on  a  uniforii
             evaluation protocol  whic-  contains iot.i quantitative  anc.
             qualitative  evaluation  factors.

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

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

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

-------
                                        -  33  -


           Pro oram  Modification	
                  EPA  uses  data  from  FATiS,  State  Program  3 a vi ew 3,  3 a g 13,12,
           reviews  and the  overall  program  review^  to  modify  '">•*  coro 1 ; 2 ica '
           enforcement program  as  necasary  and  to  give input  to  OP°  concern *->~
           regulatory  changes necessary  to  facilitate  comoliance  monitoring,
           enforcement,  or  compliance.

           Future  5u1 la nee

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

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

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

           o FIFRA  Inspection Manual  provides information  on  conducting  in(
            t i o n s,  c: i 1 ecti ng  samp" es ,  cna1! n-of-custody  procedures,  p.-2:
            suooort  documents,  and other indorsation  necessary  to cona
            FIFRA  inspections.-  This  document  snould  be  revised  if  resources
            are avai1 able.
             originalpenalty  policy  have  been  developed  over  the  years  to
::             reflect  amendments  to  the  law.   These  will all  be combined  into
             one  comprehensive document.

           o. FTFRA  Comoliance  Strategies.  The  FIFRA  Compliance Strategies  are
             developed for  all rules  promulgated  under FIFRA.   A compliance
             strategy  identifies the  (a)  requirements of  the regulation,  (b)
             the  type  of  act-Ions 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 QuaTity Assura-nce 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 the N£IC in developing  a model Quality
             Assurance Plan for  use by  the States in  developing individual
             Quality Assurance Plans.  States receiving Federal funds  for
             compliance monitoring  must submit  Quality Assurance Plans  to  EPA
             annually.


             * A  comprehensive 11st of  existing compliance/enforcement  guidance
               docym«nts  1s Included  1n the  Appendix  of tne  FIFRA  Cowplisacs/
               Enforcement  Guidance.

-------
- 39 -
   APPENDIX

-------
                                                                 FLOW
                                           NEUTRAL |
                                                IFOR  CAUSE)
  NO
ACTION
                                                        I INSPECTION!
                                                             J. ' '     (30 days to deteytilne compl lance/noncompl lance)
                                                        .   -if       .               .-  1    .IJ	,
                                                        (COMPLIANCE]               | HON-COMPUAIJTE. J
                                          (60 days  to prepare action)
                             _—	y  ,., ,,..  ,     —*
                             | ADMINISTRATIVE ACTIONS)
                                                                    |  JUDICIAL ACTIONS)
                 ADVERTISIN
                   UTTER

3
           TERNI NATION
           ESTAB. REQ.

                              1	,
                          ACTION TAKEN
                          ON APPLICAIOK
                          CFRTIFK ATIKI
                                                                                                     1
1
lit
Hi


(RFC



^
AlLSJ




STOP SALE
USE OR
REMOVAL
ORDER
1





CIVIL
PENA1




T
t-


ADM.
|E$
	 1
1

IIN.IUNC
1
1 — j

/
]buii!tt£j

r 	 J


               CRIMINAL
               PROCEEDING
             REMEDIAL
             ACT
9N
                                CACENI:Y
                                (iMpiAirn
                                                    |U.S.  ATTOHNEy'l
                                                                  UEPT
                                                                  JUSTICE
            (DEFAULT)
           NO
         ACTION
                                                 [ALJ
             DEFAULT
              ORDER
                                                      AI.U H tir NT)
                                                     —. — ~_—_._J
                                                                         HEARING]
                                                                                                i
   ToFV-
   ICE  I
   !*• ••—-—*  *
-4 NO ACflOU |
r- - "*
t
INITIAL
DECISION

                                                                        | U.S.  I) I ST. COUUT|—JNOT GUILTY J
                                              FINAL
                                              ORDER

                                     I  NOT   L
                                     I (.mi (y f
                                                                iii'HEt n(t —
                                                     APPEAL  TO
                                                    ADMINISTRATOR
                                             PENAL TY
U.S. COURT
 Ol: APPEAL
                                                                UPHELDi
                                                                                                               HOT
                                                                             U.S. SUJ'REMf
                                                                                 COURT
1                                                                                               r,u 11 ry JIIDHMFU
                                                                                              JJfjyNCJJON/SU/
                                                                                   JIIIK-MIIIF
                                                                                         /IIIU
'Determinations of compl lance/noncanpl lance are  deponent  upon  receipt of all documentation and completion of all
 Simple analyses.   Action  preparation  Is  dependent  upon resolutIon of any new policy Issues |.ti.-si;nlcv tin*
 Thif time frames are based  on the Ideal  situation.

-------
i I^Sl
                            i
ENFORCFMIW  ACllOrlli Rsill TING  FROM GRANT INSPECTIONS
               FYIM  ACCOfUM-ISIIMENTS
                lUTfHMI     National

ENFORCEMENT
ACCOMPLI SI HEMTS
i
Inspections
i
Civil Actions
Criminal Actions
Administrative
Hearings
Llconse/Cortlhcate
Suspension '
L 1 cense/Cert I I Icate
Revocation
L 1 cense/Cert 1 1 lea to
Conditioning or
Mod (Meat Ion
Number of Cases
Isfcued Warnings
Stop-|Sale, Seizure,
Quarantine or Embaryo
Cases Forwarded to
EPA for Action
Other Enforcement
Actions ,
Total Number of
Actionable Inspections
Percent of Inspections
Result Inp In Action
Percent ot total
Actions (8712)
Numbqr ol Cases
Assessed Finos
AGfllCU
Use
2,923
19
2
16
1
14
B
366
24
	 H
s
0
15.4
5.2
12
TURAL
Misuse
3.675
70
47
76
33
126
17
	 366
17
22
43
	 017
22.2
9.4
59
IIONAGRICIIUIRA!
Hsu
1,631
7
20
21
II
10
24
694
62
4
25
870
16.9
10. 1
9
Mis.lM,
I4OOJ
Kill
II
!>••
li
It

412
27
2'..
5,
U4<>
46. U
9.7
t a - a 3 -.. ;: :: :
IXP llr,F
INSP
Ml 4
20
0
0
0
0
0
	 16
3
3
0
42
1(1.9
0.5
14
PRODUCE
ES1AU
2,653
30
5
25
0
3
2
402
77
119
"~ 117
750
20.3
0.6
•3I»
MARKET-
PLACE
12,522
142
1
57
3
0
3
620
1032
163
970
2991
23.9
34.4
IM-
PORTS
523
6
0
2
0
0
0
1
0
0
10
19
3.6
0.2
CERTIFIED
API 'LICK
RECORDS
II, 175
159
90
67
502
2d

701

7
2
1561
13.9
17.9
H6 15 *,
KIT, IMC III)
USI PI SI
1)1 AUKS
9,1111
44
0
14
2
1
0
219
5U
0
9
VI /
>.'.
'1.0
•ft
IOTA!
50,104
665
242
343
565
IB6
t
57
3U02
J30I
354
1197
(1712
I/. 4
100
424


-------
                                                   1AHIE  I"
                             ENFORCEMENT ACTIONS KESOLllNli EKOH GRANT INSPECTIONS
                                            FY02  ACCOMPUSIIIOrs
                                                       HA 11 (illAl
FHFOitCEMENT
ACCOMPLISHMENTS
Inspection!
Civil Actions
Criminal Actions
Administrative
Hearings
License/Certificate
Suspension
License/Certificate
((evocation
License/Certificate
"and t Honing or
lidh (cation
Yiiniliefr of Cases
Issued Uarhtngs
Stop-Sale, Seizure,
[)uarant1ne or Embargo
r.?•••• a i
254
5.2
3.3
10
Misbse
2,401
26
15
59
29
5
13
471
12
10
17
657
27.4
0.5
25
NONAGR
Use
4,962
20
41
43
7
in
3
666
311
10
173
i a as a a ai
1 .027
20.7
13,2
5
CUTURAL
Misuse
1,792
27
152
175
21
35
3
406
54
5
52
IBB tfSBBC i
930
51.9
12.0
105
VXF HSt
INSP
313






1

311
31
9.')
0.1
(•Homier
ISIAII
2,339
2
1
14



237
116
69
14
4/3
20.2
6.1
Trarr-
PI.ACE
15.932
10
5
57


1
505
1.024
m
940
2,706
17.0
34. H
£ J 6
IM-
PORTS
174






3
1
4
: _ a ^ a a s =
0
4.6
O.I
0
CEHTIFlEn
APPLICR
RECORDS
l4,;nii
. 7
5
27
1411
'I
2
742
5
2
102
1,041
7.1
13.4
25
USE I'EST
DEALEKS
11.779
5

11
11


210
119

12/
491
4.2
6.3
II
miirir
76




1






7
124
1
3
Mr.
1
1,
9
lOTAr
59.317
120
221
406
216
60
30
3,469
1.531
224
1,479
7,764
13.1
10(1
W I'-"'
Inrliirlnc  1C\  nlhpr I ncunr t I «»n< .»ml  i
                                                                                                            .I I.

-------
                              -o - ;
FEDERAL PESTICIDE COMPLIANCE INSPECTIONS

Producer Establishment
I nspect i ons
Use Investigations
Marketplace Inspections
Import Inspections
Dealer Inspection's
Laboratory Audits/
Inspecti ons
CY70
443
482
1115
332
359
17
= Y30
234
559
320
494
955
3
r v a •
257
435
291
241
946
4
r / - ?
235
< • i
•* ; •»
233
306
719
" 13
r v : 2 '
15:
124
210
301
0
25
TOTALS                     2303     2621    2254      2021       821
2nc Quarter rYS3 Totals

-------
p-QERAL PESTICIDE ENFORCEMENT ACTIONS
                           rv79     " v 3 0    - y ~'
CivilCo™D'i3ints                 *
  Initiated                 252      175

Criminal  Referrals
  Initiate!:                   2        A

Stop Sale, Use, Removal
                                               0
Orders
Notices of Warning
Import Detentions
TOTALS
479 Ij
507
91
1332
113
831
70
1194
105
429
71
755
50
855
53
1137
42
1270
11
1545
I/ Second Quarter FY83 Totals
T/ An additional 24,000 Stop Sale Orders were issued to firms t£
   held SLisoended 2,4,5-" and Silvex products.

-------
1532,
             UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

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

SUBJECT:  Final GLP Compliance Strategy

FROM:     A. E. Conroy II, Director
          Office of Compliance Monitoring£fEN-342)

TO:       Addressees
     Attached for your information is the final compliance
strategy for the Good Laboratory Practice (GLP) regulations (also  .
attached) published on November 29, 1983 (48 £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, in the section for storage and retrieval of records
and data, that there shall  be archives for  orderly storage and
expedient retrieval of all  raw data and documentation.  Persons
will be in violation of the GLP regulations when not complying
with this provision.  Two days has generally been  accepted as
adequate notification by the other commentors and  OCM staff.

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

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

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

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

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

Response-  Same response as for comment 3.

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

Addressees

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

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

Applicabi1ity

     The GLP regulations apply to any study conducted, initiated,
or supported on or after the effective dates of the rules that
relate to health effects, environmental  effects, and chemical
fate testing under TSCA and 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 relited to TSCA Section 4 Test Rules, under
FIFRA to Section 3 'applications for registration), Section 5
(experimental use permits), Section 18 (emergency exemptions),
and Section 24(c) (registrations for special local needs), and
under FFDCA to Section 408 (tolerances for pesticide residues  on
raw agricultural commodities) and Section 409 (food additive
regulations).

-------
                               -2-                    -

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

Specific Requirements of the GLP Regulations

     The requirements of the GLP regulations  are contained in
40 CFR Part 160 (48 F£ 53946, November 29, 1983) and 40 CFR
Part 792 (48 FJR 53922, November 29, 1983).  Generally, the rules
contain proviTfons relating to:

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


     (1) General Provisions (Subpart A).

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

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

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

     (b) A statement describing in detail all differences  between
the practices used  .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 ci.vil 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
and control substances and test systems.
792.31).
                                                  test


(b)  Testing Facility Management  (Sections  160.31  and
     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 t'irection and conduct of that study.

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

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                               -4-         .         -   .

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


     (3) Facilities (Subpart C).

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

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


     (4) Equipment (Subpart D).

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


     (5) Testing Facilities Operation (Subpart E).

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


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

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

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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).
                                                  t
     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


Objecti ve

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


Violations

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

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

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


Inspection Scheme

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

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                               -7-                    '

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

     The GLP regulations require testing facilities to permit
EPA inspections at reasonable times and in a reasonable manner.
EPA believes that the possibility of unannounced inspections
motivates compliance and efficiently uses resources.  Generally,
however, EPA will notify laboratories up to two days before
an inspection in order to ensure the availability of appropriate
personnel and records.  Once EPA notifies a laboratory, it will
not change the date of the inspection unless the laboratory
demonstrates unusual  circumstances and good cause.  EPA will
coordinate with FDA and NTP 1:0 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 witli 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 stt'-jy-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 accomplished by examining raw data and other records
generated during the study and comparing them with results provided
in the study report.  Data audits will be scheduled and carried
out by OCM, with necessary assistance provided by FDA, NTP,
Program Offices, and the Regions.

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                               -8-

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


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

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

     OCM will  have the lead in directing the program by (1)
coordinating all laboratory inspections and data audits with
OPP, OTS, and the Regions, and by (2) acting as a liaison with
other agencies, such as FDA and NTP, which cooperate with EPA in
conducting laboratory inspections and data audits.  OCM will be
the Agency contact for scheduling FDA and EPA laboratory inspec-
tions and study audits, as well as for receiving and disseminating
audit and inspection reports to both OPP and OTS.  OCM will
monitor the status of each inspection and audit.
                            /'
     The Regional Offices will provide support for inspection
and enforcement activities as needed.  Regional  responsibilities
will include the conduct of and case development for most GLP
inspections.

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

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                        INTERAGENCY AGREEMENT
                              BETWEEN
               THE  U.S.  ENVIRONMENTAL PROTECTION AGENCY •
             OFFICE OF  PESTICIDES AND TOXIC SUBSTANCES
                                AND
          THE  U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
                    NATIONAL TOXICOLOGY PROGRAM
1.  PURPOSE
     This  agreement provides for cooperation between the National
Toxicology Program  (NTP) and the Environmental Protection Agency
(EPA) in the areas  of inspector training, inspection operations,
data audits and information exchange.  This cooperation will
enhance the EPA's mandated activities designed to determine
whether laboratory  testing was performed properly and in compliance
with Good Laboratory Practice (GLP) regulations and whether the
test report can be  fully validated through audits of the raw data
generated during the testing phase.
     The primary purpose of this cooperation is to utlize NTP's
experience in conducting and reporting laboratory GLP inspections
and data audits to  enhance the training and capabilities of EPA
personnel in these  activities.
2.  SCOPE OF WORK
     The Environmental Protection Agency (EPA) is responsible
for setting tolerances for pesticide residues  in  or on raw
agricultural commodities 2nd 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 Rodenticide Act  (FIFRA)(7 U.S.C. 136 et sec).  In addition,
EPA has- the mandated task under the Toxic Substances Control Act
(TSCA) (15 U.S.C.  2601) to assure that no chemical will present
an unreasonable risk of injury to health or the environment.
EPA regulatory decisions on such matters are based in part on the
results of toxicological testing performed by or for registration
applicants, tolerance petitioners, and chemical manufacturers
or processors.
     This agreement, which provides for cooperation in the
training of EPA laboratory inspectors and auditors, in providing
specific scientific expertise as required for laboratory inspec-
tions and data audit as well  as in the sharing of information on
laboratory GLP  compliance monitoring will enable EPA to
determine (1) whether the testing was performed in accordance
with specified methodology, (2) whether any reported deviations
may have affected the reliability of the test results, (3) whether
the test results as reported  can be fully supported by the raw
data generated during the study and (4) whether the testing was
carried out in compliance with EPA's GLP regulations.  The
authority for FIFRA GLP regulations is 4U CFR Part 160 and for
TSCA is 40 CFR 792.  For studies conducted prior to this, "GLP
regulations" refers to the Food and Drug Administration's GLP
Regulations (43 FR 59986).

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                                -3-





      Laboratories"inspected may  be  facilities  in  which  both  EPA



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



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



 cannot  inspect  due  the  to  the  lack  of  specific  expertise.



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



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



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



 in progress  or  completed.





 3.   EXCHANGE OF  INFORMATION



      Each agency  will  exchancie 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  t
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                                          -4-

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

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                                -5-

 NTP  personnel  In this  situation  will  be  advisory  to  the CMS
 inspector, who  has the  responsibility  for conducting  the
 inspection  or  audit  and  preparing the  report  of the  inspection
 or  audit.   The NTP  personnel's  advisory  report of  findings will
 be  incorporated into the EPA  inspector's  report.   Wherever
 possible  such  inspections will  be at  no  cost  to NTP  other than
 s a 1 a ry.
      e.   Confi denti ality - Under various  provisions  of FIFRA
 and TSCA, toxicology data submitted to EPA may be  considered
 trade  secrets  entitled to protection  from unauthorized public
 disclosure.  Such information will not be furnished.to NTP
 personnel in advance of  a laboratory  inspection or a study audit.
 Any requests for  further disclosure of such information received
 by the NTP  under  the Freedom  of  Information Act will be referred
 to the EPA  for  processing.  NTP personnel will not prepare any
 reports utilizing data which  may be confidential.
 5.  EPA'S RESPONSIBILITIES
     a.  List  of Laboratories for Coverage - EPA will provide NTP
with a quarterly  listing of labortories to be visited.   This
 listing is  to  be provided to  NTP at least 30 days   in advance  of
a given quarter and will  include the name(s) of the facility(ies )
to be inspected, the dates of the inspections and  the EPA
scientific  personnel who will participate in the inspection
or audit.   This information will be classified as   "For  Official
Use  Only" and should not  be disclosed except on a  need-to-know
basi s.

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                                    -b-
     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 FIFrtA and
TSCA, to maintain confidentiality of certain test-related infor-
mation.  EPA will not provide NTP any material classified as
FIFRA or TSCA  "Confidential Business Information."  EPA may
furnish NTP with material classified as "For Official Use Only"
which is not to be disclosed by recipient NTP personnel to others
except on a need-to-know basis.
     e.  NTP Requests - EPA will respond to all requests for
information received by NTP under the Freedom of Information Act
which relate to visits performed for EPA by NTP.

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                                 -7-
      f.   Delegation  of  Authority  - As  necessary-EPA will  provide
 to  NTP  personnel  a  letter  containing  appropriate  delegation of
 authority.   This  letter will  then be  furnished  to the management
 of  the  laboratory  at  the beginning of  the  visit.
      g.   Notification of Sponsor  - Contracts may  exist between
 laboratory  and  sponsor  prohibiting disclosure of  raw data by the
 laboratory  without the  permission of the sponsor.  In order to
 ensure  that raw data  are available to  EPA  and NTP personnel
 conducting  a  data  audit, EPA's Compliance  Monitoring Staff will
 notify  the  sponsor of the  study of the intent to  audit one or two
 working  days  preceding  the  scheduled visit.  CMS will exercise its
 own discretion  regarding advance  notification to  the laboratory
 of the  scheduled  visit.
      h.   Evaluation of  Reports - EPA will  determine whether
 discrepancies listed in  the: compliance inspection reports submitted
 by NTP  personnel  or study  iiudit 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 the
 content  and scheduling  of  training courses and workshops and will
 jointly  determine the faculty for such courses and workshops.
Both  EPA  and  NTP  staff  will be invited to  attend such courses  and
workships as  appropriate.

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                               -8-     '

 6.  DURATION OF AGREEMENT
     This  agreement will .become effective on the date of the last
 signature  and shall continue in effect until September 3U,. 1984,
 unless modified by mutual written consent of both parties or
 terminated by either party upon a ninety (90) day advance written
 notice to  the other.  This agreement may be reviewed by written
 consent of both parties on a fiscal year basis.
 7.  PROJECT OFFICERS
     For EPA:  Dr. Dexter S. Goldman (EN 342)
               Head, Laboratory Data Integrity Program
               Compliance Monitoring Staff
               Environmental Protection Agency
               401 M Street, S. W.
               Washington, DC  20460
     For NTP:  Dr. Bernard A. Schwetz
               Chief, Systemic Toxicology Branch
               National Toxicology Program
               National Institute of Environmental  Health Sciences
               P.O. Box 12233
               Research Triangle Park,  NC  27709
8.  FUNDING
     No transfer of funr!s is necessary  under this agreement.   Each
agency  will fund its part of cooperative actions.  EPA will  fund
travel  and travel  associated expenses of NTP personnel requested
to participate in  EPA activities described above.

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

    BY
       0Dhn  A.  Moore, DVM
    TITLE:   Assistant Administrator
             for  Pesticides and
             Toxic Substances
    DATE:
-£/
APPROVED AND ACCEPTED  FOR '
T.HE NATIONAL TOXICOLOGY
PROGRAM
   David P. Rail ,  MD,  Ph.D
TITLE:   Director
DATE:

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

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                               -2-




2.  PROGRAM ABSTRACT





     CMS will establish and chair the .Laboratory Data Integrity  -



Program Panel (the Panel) which will  also include members  from



OPP and OTS.  The Panel will serve as the conduit for the  flow



of information between participating  Offices and will periodically



review LDIP policies, procedures, and operations and advise  the



Director, CMS, who has full responsibility for implementing  the



program, of recommended program improvement and changes.   The  Panel



will  serve as a steering committee to ensure that Agency commit-



ments and objectives of the LDIP are  fully implemented and



met.



     The CMS will have the lead in directing the program by  (1)



coordinating all FIFRA- and TSCA-related laboratory inspections



and study audit activities with OPP and OTS as well as by  (2)



liaison with other agencies, such as  the Food and Drug Administra-



tion  (FDA) and the National Toxicology Program (NTP), which


cooperate with the EPA in laboratory  inspections and data  auditing.



LDIP  will be the Agency contact for scheduling FDA and EPA labora-



tory  inspections and study audit activities, as well as for  receiv-



ing and disseminating audit and inspection reports to both OPP and



OTS.   LDIP will monitor the status of each inspection and  audit.



     It is the goal of LDIP to (1) ensure full compliance  with



FIFRA and TSCA Good Laboratory Practice (GLP) regulations, as


applicable, a.*; all testing facilities performing studies  to  be
                  i


presented to the EPA to meet requirements of both FIFRA and



TSCA  and (2) to audit fully all data supporting the  results  of

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                               -3-

these studies.  Both the CMS iind the OPTS Program Offices  are
responsible for.recommending studies for audit  and laboratories
for inspection.
     The OPTS Program Offices will provide the  scientific  review
of laboratory GLP inspection reports and data  audit   reports of
studies within their respective program areas  to  LDIP.   Program
Office scientists will participate in inspections and  study
audits at laboratories, as appropriate and as  resources  permit.
     A detailed description of the responsibilities  of CMS,  LDIP,
OPP, OTS and the Panel is given in Section 3 of this document.
     A detailed definition of terms used in this  document  is given
in Section 5 of this document.

3.  DIVISION OF RESPONSIBILITIES

     a.  Compliance Monitoring Staff
          (1) Appoints the Chairperson of the  Panel.
          (2) Establishes inspection procedures and  specific audit
procedures, with necessary technical input and  review from OPP
and OTS.
          (3) Establishes neutral  administrative  inspection  schemes
for routine selection of laboratories for inspection and,  based
on recommendations from 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 duplicative efforts and to achieve maximum efficiency in

auditing studies used for government decision  making.

         (2) Trains EPA inspectors and auditors  in the conduct  of

laboratory inspections and audits with technical assistance from

OPP, OTS, FDA, NTP and contractors as needed.

         (3) Establishes and maintains an accessible  data  file  o^

studies submitted to or required by the EPA under  TSCA Section  4

Test Rule or Negotiated Testing Agreement, TSCA  Section  5  Signifi-

cant New Use Rule, Section 5(e) Order, FIFRA Sections 3, 5, 8,  18

and 24(c) as well as FFDCA Sections 408 and 409.  This data file

will be maintained and updated by LDIP staff and will  permit  the

tracking of both CMS-directed activities on studies as well as

OPP- or OTS-negotiated study milestone dates starting with  the

date of agreement betwe'.-n OPP or OTS and Sponsor and  ending with

the final study data audit report.

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

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                               -6-

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

sentative will  also be the focal  point for all  information  exchange
between  OPP, OTS and CMS and will  serve  as technical  program  repre-
sentative.
          (2)  Provide LDIP with information needed  to track  studies
submitted to or required by the EPA under TSCA  Section 4 Test
Rule or  Negotiated Testing Agreement, TSCA Section  5  Signifi-
cant New Use Rule, Section 5(e) Order, FIFRA Sections 3, 5,  8,  18
and 24(c) as well as FFDCA Sections 408 and 409.
          (3)  Maintain a current  awareness of LDIP-set laboratory
GLP inspection and study audit schedules from the LDIP data  file.
Recommend to LDIP changes in these schedules when problems  are
noted that may jeopardize a study.  Such requests will contain
an assessment  of the need for the inspection or audit based  on
OPP or OTS review, pending regulatory decisions and other estab-
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  room 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) Serves as a steering committee  to oversee  the  manner
              *     s
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:
             -5    /
             (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 (FIFRA).  A GLP inspection is an  inspection of  a  test
facility or laboratory where EPA-related test  data are  generated.
The purpose of such an inspection is to ensure full  compliance  with
GLP's (as regulations).  GLP inspections may be  carried out  by  EPA
inspectors or by inspectors or other designees of  other government
agencies under interagency agreements.  At present such an inter-
agency agreement exists between EPA and FDA.
     Other definitions pertaining to studies  and to  GLP are  con-
tained within the GLP regulations.

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                              -10-
6.   CONCURRENCES
    V /Tr*-*^^
        Moore,  D.V.M.
Assistant  Administrator
for Pesticides
and Toxic  Substances
                                      Date
                                               O
                 •LS
Don R.  Clay,  Dired
Office  of Toxic  Substances
Date
Edwin L.  Johnson,  Director
Office of Pesticide  Programs
                                        Date
A. E. Conroy/11 ,| Di rector
Compliance Mbnitbring  Staff
Office of Pesticides  and  Toxic
 Substances
                                         Date

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X,
              UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                          WASHINGTON, D.C. 20460
                              SEP 3  1985
MEMORANDUM


SUBJECT:


FROM:


TO:
                                                            OFFICE OF
                                                    PESTICIDES AND TOXIC SUBSTANCE!
        Compliance  Strategy  for  FIFRA  §3(c)(2)(B)
        Suspensi ons
        A.  E.  Conroy  II,  Director
        Office of  Compliance  Monitoring

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

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

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

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

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

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

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

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

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

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

Attachments

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                                                        SGP  3665
        COMPLIANCE STRATEGY FOR FIFRA §3(c)(2)(B) SUSPENSIONS
OVERVIEW	

     Section 3(c)(2)(B) of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) authorizes the Administrator to
require registrants to develop arid 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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o
                                -2-

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

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

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

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 und 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.

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

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

PENALTIES                  ~                                   ~

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

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       3     UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

      f    '             WASHINGTON, D.C. 20460
                                                          OFFICE OF
                                                  PESTICIDES AND TOXIC SUBSTANCL
MEMORANDUM
SUBJECT:  Compliance Monitoring Strategy for Pesticide
          Registration Cancellations Due to Nonpayment of Fees

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

TO:       Addressees


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

     The effective date of cancellation for the first fee period
was October 10, 1989, the date of the letter informing                 I
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             i
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        c
cancelled for nonpayment of fees under FIFRA section 3 and             y
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.               t
                                                                       H
     Please provide copies to the State pesticide control              z
officials in your Region as soon as possible.  If you have any         ft
questions regarding the Strategy, please contact Beverly Updike
of my staff at FTS 475-9438  (EN-342).


Attachments
                                                            Printgd on Recydij Paper

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                   ADDRESSEES
           l'    Louis F. Gitto, Director
                Air, Pest. & Toxics Mangt. Div.

           II   Eiarbara Metzger, Director
                Environmental Services Div.

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

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

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

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

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

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

           IX   David P. Howekamp, Director
                Air Management Div.

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

-------
     Douglas D. Canpt
     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)
                                it
                                it
                                n
                                it
                                n
                                n
                                ii
                                n
                                n
                                n
     Jake Mackenzie
     Western Regional Compliance Director
II
     Marvin Rosenstein, Chief
     Air, Pest. & Toxics Mangt. Div.
     Pest. & Toxic Substances Br.

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

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

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

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

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

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

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

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   RESPONSE TO COMMENTS OM PESTICIDE CANCELLATION STRATEGY


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

Existing Stocks

COMMENT 1

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

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

RESPONSE 1

We have incorporated that sstatement into the Summary.
COMMENT 2                                                              I
- -                                                               \
A commenter reported that the proposed existing stocks provision       ;
presents a problem for those States in which pesticide products        i
must have a current EPA registration to be offered for sale.           'r

RESPONSE 2

State inspectors should take their direction from the State laws       ^
in those States which have more stringent laws regarding the           £
distribution and sale of existing stocks of pesticide products no      £
longer registered by the EPA.                                          ;
Enforcement Response
                                                                       t
COMMENT 3                                                              J
                                                                       i-
One commenter asked what would be the appropriate enforcement          ?
action if the inspectors discovered pesticides on the                  p
cancellation list in the marketplace.                                  £

RESPONSE 3                                                             1
                                                                       §
If an inspector finds existing stocks at the user and dealer           £
level which have been produced, packaged or labeled after October
10, 1989 (effective date of cancellation) , those stocks are in
violation of the Cancellation Order. Registrants had until March
1, 1990, to dispose of existing stocks of cancelled products.  A
Stop Sale, Use or Removal Order (SSURO) should be issued for
violative acts and penalties! assessed as needed.

-------
Cancellation Information

COMMENT 4

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

RESPONSE 4

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

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

RESPONSE 5

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

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                        SUMMARY
      COMPLIANCE MONITORING STRATEGY FOR PESTICIDE
  REGISTRATION CANCELLATIONS DOB  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 FIFR& states that the Administrator may
cancel the unpaid registrations without a hearing.  Accordingly,
Cancellation Orders were issued to cancel the majority of the
unpaid registrations.  This group includes approximately 13,500
products registered under section 3 of FIFRA and about 6,000
under section 24(c) of FIFRA.  The Notice of Cancellation was
published in the Federal Register on October 18, 1989 (54 FR
42936).  However, the effective date of cancellation was October
10, 1989, the date of the cancellation letter.  As new
cancellations go into effect for subsequent fee periods, OCM will
provide an amendment to Appendix II which will inform the Regions
of the products cancelled, the date of the cancellation, and any
existing stock provisions.

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

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

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


REQUIREMENTS

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

     In the case of exports, any products exported after the             r
effective date of cancellation must comply with section 17 of            k
FIFRA, which includes citations for other applicable FIFRA               2
requirements. Under section 17, prior to export, a foreign               £
purchaser must sign a purchaser acknowledgement statement and a          ^
copy of that statement must be submitted by the exporter to EPA.         £
In addition, note that unregistered pesticides intended for              ^
export must conform with labeling requirements pursuant to               £
section 17, including section 2(q)(l)(H) (i.e., the label must           5
say in a conspicuous manner "Not Registered for Use in the United        g
States of America").                                                     ^
                                                                         N
                                                                         ^
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             P
producing establishment after March 1, 1990, Stop Sale, Use or           g
Removal Orders (SSUROs) should be issued.  Prior to establishment        $
inspections, States should check the list of producing
establishments to determine if an establishment has produced one
or more of the products since 1984.  Appropriate enforcement is
also to be taken for violative products.

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

Office of Pesticide Programs (OPP)	

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

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

Office of Compliance Monitoring (OCM)	

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

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

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

Regions	
r  i*

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.

-------
States	

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

Will take enforcement action and issue Stop Sale, Use or  Removal
Orders (SSUROs), as appropriate.
                                                                         w
                                                                         •
                                                                         c
                                                                         (D
                                                                         vo
                                                                         £>
                                                                         U>
                                                                         CO
                                                                         p.
                                                                         I

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                            APPENDIX Z
The following registrants for the pesticide products listed
below, which were previously included among the 189 deferred
products, are now in compliance with the 1989 maintenance fee
requirements of FIFRA.
          Registrant &
Reg.No.   Product No.

#47319    Savanah Co.
          047319-00001
          047319-00002
          047319-00004

#11275    Guth Corp.
          011275-00002
#01457    Hexcel Corp.
          001457-00015

#08730    Hercon Environ-
          mental Co.
          008730-00035
Product Name
  Sevana Bird Repellent
  Sevana Bird Repellent
  Agrigard Insect Repellent
  Lithate 2,4 D - Broadleaf Weed Killer
  Non-Volatile
  Bromat
  Lure N Kill Roach and Ant Killer
  Insecticidal Baits With Sex Lure

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                                               APPENDIX II

                                      SUMMARY OF CANCELLATIONS
FEDERAL
REGISTER
NOTICE
MAINTENANCE
FEE PERIOD,
MARCH 1
NUMBER OF
PRODUCTS
CANCELLED
EFFECTIVE
DATE OF
CANCELLATION
EXISTING STOCKS AT
REGISTRANT, DEALER &
USER LEVEL
10-18-89
 88-89
                 13,500 sec. 3
                  6,000 sec. 24(c)
                      10-10-89
                  Registrant can continue to sell and
                  distribute stocks until 3-1-90. Dealer
                  and user can use existing stocks until
                  exhausted.  Existing stocks are defined
                  as those products produced, packaged or
                  labeled by 10-10-89.

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                                    APR 30 1.990
                                                    i " : - -. i .•• • '1 " ;X!'J SUBSTANCES

MEMORANDUM

SUBJECT:  Strategy for Aldicarb

FROM:     John J. Neylan III, Director 7$^-^
          Policy and Grants Division
          Office of Compliance Monitoring (EN-342)

TO:       Addressees

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

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

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

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

Attachments

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 Addresses:

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

Jake Mackenzie
Western Regional Coordinator

Louis Gitto, Director
Air Management Division, Region I

Barbara Metzger, Director
Environmental Services Division, Region II

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

Winston A. Smith, Director
Air, Pesticides & Toxics Management Division
Region IV
0
William H. Sanders III, Director
Environmental Sciences Division, Region V

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

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

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Irw.in L Diskstein, Director
Air and Toxics Division, Region VIII

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

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

BRANCH CHIEFS:

Marvin Rosenstein, Chief
Pesticides & Toxic Substances Branch
Region I

Ernest Regna, Chief
Pesticides & Toxic Substances Branch
Region II

Larry Miller, Chief
Toxic & Pesticides Branch
Region III

Richard Stonebraker, Chief
Pesticides & Toxic Substances Branch
Region IV

Phyllis Reed, Chief
Pesticides & Toxic Substances Branch
Region V

Robert Murphy, Chief
Pesticides & Toxic Substances Branch
Region VI

Leo Alderman, Chief
Pesticides & Toxic Substances Branch
Region VII

Alvin Yorke, Chief
Toxic Substances Branch
Region VIII

Davis Bernstein, Chief
Pesticides & Toxic Substances Branch
Region IX

Kenneth Feigner, Chief
Pesticides & Toxic Substances Branch
Region X

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

COMPLIANCE ACTIVITIES

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

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

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

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

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

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

                             JOINT SATEMENT BY

                      ENVIRONMENTAL PROTECTION AGENCY

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

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

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

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

       EPA will continue to review and monitor this situation and t.ike i:.y
   further action if necessary.
   -52

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• V/;'/ i"    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
r, ,.,,.'..^>'                     WASHINGTON. D.C.  2CM60

                                           JAN 1 o 1975
 To:        Regionj,lJUlministrators

                 Qtt-rrs.f-s £.  X^-C'Cr
                 uvt Administrator* lor water
          and Hazardous. Materials (WH-556)

          Assistant Administrator for Eiifbrcemen'/V
          and General Counsel (EG-329)

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

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

     Accordingly, our joint staffs are preparing a Federal Recastor notice,
 v/hich, upon  publication, vn.ll formally assert Fed"^r"al~3urisdiction over
 non-Fcclorally  registered products  containing  Atfi'rin and Dieldrin by
 impl^'iv.cntinrj Scct-lcvi 3. of the Federal insecticide; Fun^Lcid^ and
 Rcdsr.Ucide Act (FIFRA), as amended (7 U.S. C. 136 et seo.). Attached
 is a strategy paper \vhich explains the background of this matter in greater
 detail and  provides an explanation of ho'.v these Aldrin and Dieldrin pro-
 •ducts should be treated upon the activation of Section 3.  In addition,
 proposed enforcement activities by the Agency, anticipated in cooperation
 \sith involved States, is discussed.

     We shall expedite publication of this notice in the Federal Register.
 Pending  formal publication, you should  proceed v.ith  confidence in the
 proposed substance of the notice as outlined above and in the attached
 paper to inform affected States in your Region of  these developments.,
 Further, \vetrustyou v.ili encourage their support and cooperation in our
 effort to achieve orderly and equitable disposition of existing State-reg-
 istered products together v.ith  even-handsd ?.ud comprehensive enforce-
 ment' of the  Aldrin-Dieldrin cancellation and  suspension  orders.  The
 Enforcement Division o:  each  region v.ill be contacted by th-3 Pesticides
 Enforcement Division in Washington v/hich v.ill provide  additional doiails
 and support,  v/hcrc needed, to achieve Federal-State cooperation in  pro-
 viding notice of  these  developments and in  proceeding v.it.h enforcement
 of the Administrator's orders relating to cancellation and suspension of
 Aldrin and Dieldrin.

 Enclosure:
                 •*•

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         UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                        WASHINGTON. D.C. 20460
Strategy Paper:

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


Background;

    Late in  December, 1974 Headquarters was informed by Region IX
and the State  of California that products containing Aldrin and Dieldrin
were being.registered by the State in possible contravention of  the intent
of the Administrator's Order of December 7, 1972 (37 F.R. 26463, 25463).
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 registr?.tions. " 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 State.-;) have revealed that many State-
re«ist."ved Alck-Ln-Dieldrin products were:   1) formulated from technical
material held prior to December 7, 1972  and  therefore not subject to  the
restrictive  labeling requirement,  2) formulated from so-called "end-
use" or finished Aldrin-Dicldrin products bearing State or Federal
rcgistx-ations and lacking any stated restrictions concerning refor-
mulation, 3) formulated from technical mete rial sold after December 2,
1972 which failed to bear  the required restriction,  4) formulated from
technical material restrict!vely labeled and ignored  by the forrnulator.
Stales,  having lately become aware, of the intent of the Decemoer, 1972
order, are faced with a dilemma: pressure to reregister for continued
shipment, sale and use products formerly approved by them and the
likelihood that such registration  contravenes at least the spirit,  and- in
some cases possibly the letter,  of a Federal  cancellation order.

Action;

   In order to clarify existing ambiguities concerning the legal status of
these non-Federally registered  products  with respect to Federal  junc'Hc-
tion over their production, shipment,  sale, and use, and to insure -jven-
hanclod enforcement of the Aldrin and Dieldrin cancellation and  suspf'pion
orders, ihe Agency will formally implement Section  3 of the Federal Insec-
ticide, Fun'gicide, and Rodcnlicide Act, as amended  (7-U. S. C.  136 ct seq.)
by notice in the Federal Register.  This notice will contain an exemption,

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                                -2-

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

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

    The Agency's pesticides enforcement personnel will enlist State coope-
ration in continuing its on-going investigation of the formulation since
December  7, 1972, o:  products containing  Aldrin or  Dieldrin for State
         D'.IO  Should it be the case that Federal registrants of technical
A.ldrin c
-Dieklrin have not r«^i.~belc<") their orocv.cts in conl'ormancc with
the Adr.vnistrcJ.or's Order of December 7, 1972, or that pesticide pro-
ducers have  formulated products  containing Aldrin  or  Dieldrin in con-
travention of labeling prohibitions against xise in non-FcderaUy registered
products,  such viclr.ticns will be prosecuted in accordance with the apprc-
priaue provisions of the Act.

-------
      UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                     WASHINGTON. D.C. 20460
To:      [Enforcement Division Directors]
From:   A. E. Conroy II, Director
         Pesticides Enforcement Division
                                         H-ZC-JL^
                                         /* •         x^\

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-Federally registered products containing Aldrin and Dieldrin
could subject such products to stop sale and their producers to liability
under Sections l2(a)(2)(G) and (K) of  the Act.

   Subsequent to  the Director's memorandum, it has come to the
Agency's stter>tion that numerous products containing Aldrin and DLeldrin
r-'.a^' have be~n produced since December 7. 1972 and ppcristPt-AH v>y .^fot^a
under circumstances not strictly contravening the  December,  1972 Order.
Details concerning this production and questions relating to the scone of
Federal jurisdiction over such production under the Dscember, 1972
Ord**'* are elaborated in the attached memorandum and strategy paper,
which »vere sent to all Regional Administrators on January 10, 1975.

Action;

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

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

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

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

         5) EPA regional  personnel are to continue  their investigations
            of production since December 7,  1972 of products contain-
            ing Aldrin and Dieldrin for 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 regarn to any
of these matters,  please notify the appropriate Regional Coordinator.


Attachments:

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                                         Attachment I

                   Aldrin - Dieldrin Strategy

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

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

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

4.  PEP sends Administrator's order to Regions

5.  HDQ sends Administrator's order to States

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

7.  Regions  follow-up at each State registrant.

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                                     Attachment  II SAMPLE LETTER
State Registrant
(Address)
Gentlemen:

    On (date), the Administrator of the United States Environmental
Protection Agency issued an Order asserting Federal jurisdiction over
all non-Fedcrally registered Aldrin-Dieldrin products in intrastate
commerce by invoking Section 3 of the Federal Insecticide Fungicide,
and Rodenticide Act (FIFRA),  as amended (7 U.S.C. 136 ct seq.).
As a result of this Order,  the  shipment,  sale,  and use of non-Feder-
ally registered Aldrin-Dieldrin products, produced after the effective
-d^rte-of-the-Qrd-cr~\y-iHr-be-prohibited-.- At^ct3rdingiyr^he-5tatg-of--(TraTn-e)
can register or continue registrations only of non-Federally registered
Aldrin-Dieldrin products \vhich were produced on or before the date
of the Order. Such  registrations are being permitted to allo\v the
orderly disposition of non-Federally registered products through
shipment,  sale, and use in the registering State.

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

                                       Sincerely,

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                                             Attachment III

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

1.  Failure of a Federal registrant to place a statement such as "For
    use only in formulating products bearing EPA-approved F1FRA
    registrations" on manufacturing use only labels.

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

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

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

3.   Sale of a non-Federally registered Aldrin - Dieldrin product pro-
    duced after the effective  dale of the Order, but before violations
   are actionable (GO clays after  publication in the Federal Register).

         Action:    Slop SaL-

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

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

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            UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                        WASHINGTON, DC 20460
                        JUN   6 1989                        a™**
                                                         PESTICIDES AND
                                                         TOXIC SUBSTANCES
MEMORANDUM

SUBJECT:  Compliance Strategy  for the Cance
          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 herblcldal  use of  the flowable  formulation  of
calcium arsenate, the  grapefruit growth regulator  use  of  lead
arsenate, the grape fungicidal use of sodium  arsenlte,  and  the
deslccant uses of arsenic acid on cotton  and  okra  grown for
seed, i.e., the major  uses,  are  still under special  review
awaiting food crop residue data  from registrants  as  requested
under FIFRA §3(c)(2)(B) .

     Compliance with the  NOIC will be determined  by  Inspection
of registrants and producers of  cancelled products  to  determine
If production and sale for distribution within the  U.S. has
ceased and that distributors have been notified of  the  action
as required by the Notice.   Inspections of dealers  and  users
will  be conducted to ensure  that cancelled products  are no
longer being sold or used.   Tips and complaints are  to  be
Investigated as received.

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

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

     Barbara Metzger, Director
     Environmental Services Division

III  Stephen R. Wassersug, Director
     Hazardous Waste Management Div

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

V    WilliamH. Sanders III, Director
     Environmental Services Division

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

VII  William  A. Spratlln, Director
     Air and Toxics Division

VIM Irwln L. Dlcksteln, Director
     Air and Toxics Division

IX   David P. Howekamp, Director
     Air Management Division

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

                                   Ernest Regna, Chief
                                   Pesticides 4 Toxic Substances Br

                                   Larry Mi Iler, Chief
                                   Toxic 4 Pesticides Branch

                                   Richard DuBcse, Chief
                                   Pesticides 4 Toxic Substances Br

                                   Phyllis Reed, Chief
                                   Pesticides 4 Toxic Substances Br

                                   Robert Murphy, Chief
                                   Pesticides 4 Toxic Substances Br

                                   Carl Walters, Acting Chief
                                   Pesticides 4 Toxic Substances Br

                                   Alvln Yorke, Chief
                                   Toxic Substances Branch

                                   Davis Bernstein, Chief
                                   Pesticides 4 Toxics Branch

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

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

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

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

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

Regulated Industry	

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

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                             -2-


Existlng Stocks	
     As of August 8,  1988,  no existing stock  of  any  cancelled
product may be distributed,  sold,  offered  for sale,  held  for
sale, shipped, delivered for shipment, or  received  and  (having
so received)  delivered or offered  to deliver, or used.  This
includes products voluntarily cancelled which would  otherwise
still be allowed to be sold  under  the terms of the  voluntary
cancellation.  Persons holding existing stocks of cancelled
products must dispose of them In accordance with the applicable
requirements  of the Resource Conservation  and Recovery  Act
(RCRA).  NoncompI Iance with  the cancellation  order  Is a
violation of  FIFRA  §§12(a)(1)
-------
                             -3-
WIII 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.

WIN conduct Inspections In States without Cooperative
Enforcement Agreements as part of their routine inspectional
scheduIe.

Will take enforcement actions as appropriate.

States	

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

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

Will take enforcement actions as appropriate.

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

-------
     INORGANIC ARSENICALS NON-WOOD PRESERVATIVE USES
               NOTICE OF INTENT TO CANCEL
All non-wood preservative uses of inorganic arsenical pesticide
products are cancelled effective August 8, 1988, with the
exception of the following uses.


The following registrations will be retained without change;

1.  Arsenic trioxide insecticide use (solid formulation
    manufactured in a sealed metal container only) for:

    Domestic outdoor - domestic dwellings
    Domestic indoor - domestic dwellings

2.  Arsenic trioxide mole, gopher, and pocket gopher killer use
    (solid formulation only) for:

    Domestic outdoor - domestic dwellings
    Terrestrial non-food crops - golf courses, ornamental
    plants and lawns, non-crop areas


Registrations not considered in this action;

1.  Lead arsenate plant growth regulator use on grapefruit.

2.  Sodium arsenite fungicide use on grapes.

3.  The desiccant uses of arsenic acid on okra (grown for seed)
    and cotton.

4.  The flowable formulation of calcium arsenate for use on
    turf.

Decisions on these uses are deferred pending the Agency's Risk
Assessment Council's reassessment of the carcinogenic potency
of inorganic arsenic for dermal exposure and the receipt of
dietary exposure data the Agency has requested.


Effective Dates

As of August 8, 1988, no existing stock of any cancelled
product may be distributed, sold, offered for sale, held for
sale, shipped, delivered for shipment, or received and (having
so received) delivered or offered to deliver, or used.  This
includes products voluntarily cancelled which would otherwise
still be allowed to be sold under the terms of the voluntary
cancellation.

Registrants were required to notify their distributors of
cancelled inorganic arsenical products by July 25, 1988, to
inform them of the time limitations on distribution and sale of
existing stocks in the hands of the distributor.

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                PARTIES REQUESTING A HEARING
Jones Products Company
Box 204
Middleton, WI  53562

Jones Ant Killer   EPA Reg. No. 29-4
Senoret Chemical Company
566 Leffingwell Ave.
Kirkwood, MO  63122

Terro Ant Killer   EPA Reg. No. 149-2
General Pest Service Co.
1819 Goldfield Street #B
North Las Vegas, NV  89030

Ant 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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l»
: PBoLt0
          UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                      WASHINGTON, D.C. 20460
                          JUL  6
                                                       OFFICE OP
                                                PESTICIDES AND TOXIC SUBSTA
MEMORANDUM

SUBJECT:  Compliance Strategy for the Conditional Registration
          and- Cancellation of Certairfi\$romoWni IxPToducts
                                      X,. X X  , i ^
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
      Douglas D. Campt    (H7501C)
      Edwin F. Tlnsworth  (H7505C)
      Anne Lindsay        (H7505C)
      Frederick F. Stlehl  (LE-134A)
      Mark Greenwood   ,   (LE-132A)
      A.  E'. Conroy I I      (EN-342)
      Conn is Musgrove         "
      Mike Wood              "
      Jerry Stubbs           "
      Sherry Sterling         "    .
      David DulI              "
      Ken Kanagalingam       "
      Bob Zisa  .             "
      John J. 'Neyian  III      "
      PhylI is  E.  Flaherty     "
      Maureen  Lydon           "

      Jake Mackenzie
      Western  Regional  Compliance Director
VI I
VI I I
IX
Louis F. Gi.tto, Director
Air Management Division

Barbara Metzge'r, Director '
Environmental Services Division

Stephen R. Wassersug, Director
Hazardous Waste Management DIv

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

William H. Sanders  III, Director
Environmental Services Division

William B. Hathaway, Director
Air, Pesticides 4 Toxic Division.

William  A. Spratlln, Director
Air and Toxics Division

Irwln L. DIcksteIn, Director
Air and Toxics Division

David P. Howekamp, Director
Air Management Division

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

Ernest Regna, Chief
Pesticides 4 Toxjc Substances Br

Larry Mi Iler, Chief
Toxic 4 Pesticides Branch

Richard DuBose, Chief
Pesticides 4 Toxic Substances Br

PhylI is Reed, Chief
Pesticides 4 Toxic Substances Br

Robert Murphy, Chief
Pesticides 4 Toxic Substances Br

Carl Walter, Acting Chief
Pesticides 4 Toxic Substances Br

Alvin Yorke, Chief  '
Toxic Substances Branch

Davis Bernstein, Chief
Pesticides 4 Toxics Branch

Kenneth Feigner, Chief
Pesticides 4 Toxic Substances Br
cc:  Michael Walker      (LE-134P)
     Jim Roeloffs        (TS-788)
     John TIce           (TS-769C)
     Al Heier            (A-107)

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    SROMOXYNIL CONDITIONAL  REGISTRATION AND  VOLUNTARY CANCELLATION

              COMPLIANCE MONITORING  STRATEGY  SUMMARY  SHEET
  1.    Conditional  Registration  of products containing  Buctril,
        Bronate,  and Buctril +  Atrazine.
TARGET DATE FOR
INSPECTION
by 9/6/89*
          CONDITIONS OF REGISTRATION TO BE MONITORED BY
          INSPECTION             .
          5/25/89;  Point-of-purchase communication carried
          out by registrant per schedule in conditions of
          registration.

          Used only by certified applicators according to
          conditions of registration.
                                                      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
)
Registr
Produce
Distrib
                                                    User
between 10/1/89
and 11/1/89
between 10/1/89
and Spring, 1990
growing season
Revised Labelling on all products by 10/1/89; all
bulk containers have correct transfer mechanism by
10/1/89.
Compliance with EPA-approved user training plan.
Plan must be implemented prior to 1990 Spring
growing season.
• Registr,
Produce:
Registr£
User
' Interfac
  2.
Vo 1 untary Cancellation  of Broiiioxynil.  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

                                                    Distribut

                                                    User
*    As part of routine inspections.

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

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

     Bromoxynil is 'a selective, postemergence herbicide used to
control broadleaf weeds primarily in field corn, wheat, garlic,
barley, oats, rye, sorghum, onions and flax.  Most use occurs
between February and June on small grains and corn.

     On May 5, 1989 the Agency approved an Agreement with Rhone-
Pou,lenc to conditionally amend the registrations of three
bromoxynil pesticide products (buctril, bronate, and buctril +
atrazine), pursuant to FIFRA section 3(c)(7)(A).

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

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

     Under FIFRA Section 3(c)(7)(A), EPA.has imposed certain
conditions for the continued registration of three bromoxynil
octanoate products (buctril, bronate, and buctril + atrazine).
These conditions include adding warning statements to the
product labels stating that exposure during pregnancy causes
birth defects in laboratory animals, restricting its use to
certified .applicators, and requiring additional protective
clothing for mixers, loaders and applicators.

     The registrant is also required to conduct an extensive
notification and educational program for bromoxynil users to
inform them of the potential birth defect risks for mixing,
loading and applying bromoxynil as well as the importance of
following the new risk reduction measures.

     The registrant is also required to provide extensive
data within specified time frames and interim reports to enable

-------
                                     -2-

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

 Stocks  of Products  With Amended  Stickerina/Labeling	
      By May  6,  1989  the  registrant was  required to halt shipment
 of  all bromoxynil  products  until  approved  amended stickers are
 affixed to each container within  the company's possession.

      By May  15, 1989,  the registrant was required to provide
 each  distributor holding inventory of bromoxynil products
 sufficient stickers  for  such  inventory.

      By' May  25, 1989 the registrant was required to provide each
 reseller  and retailer holding inventory of bromoxynil products
 sufficient, stickers  for  such  inventory.

      The  registrant  was  also  required to provide each
 distributor, reseller, and  retailer with instructions concerning
 the manner in which  the  sticker must be affixed to each
 container, and  to  implement the attached labeling communication
 plan  by the  dates  described therein.

      The  registrant  is also required to assume responsibility
 for insuring that  each distributor, reseller or retailer
 attaches  the sticker to  each  container  which is sold or
 distributed  by  the distributor, reseller or retailer after the
 date  the  stickers  are received.

      After October 1, 1989, revised labeling, which deletes all
 claims, references,  and  use directions  pertaining to the
.previously permissible uses for turf and non-crop areas,  and
 which includes  all new label  provisions as required by the
 agreement, must be attached to the containers of all bromoxynil •
 products  released  for shipment by the registrant.

 Additional Requirements	_____	

      By October 1, 1989, the  registrant must develop and  submit
 to  EPA a  proposed  program to  provide additional training  to
 users of  bromoxynil  products  prior to the  1990 spring use season
 and will  implement the program once it  has been approved  by EPA.

      By October 1, 1989, the  registrant is also required  to
 establish a  program  to provide assistance  to users who do not
 own a mechanical transfer system  which  terminates  in a drop-
 free  hard coupling and who  wish to obtain  such a system or  to
 modify their present system.

      After October 1, 1989, the  registrant is required to insure
 that  all  bulk containers released for shipment  include a
 mechanical transfer  mechanism which terminates  in  a drip-free
 hard  coupling which  may  be  used only with  a spray  or mix  tank
 which has been  fitted with  a  compatible coupling.

-------
                                    -3-
     By January  l,  1990, the registrant is required to have
 investigated and reported to EPA, the feasibility of packaging
 bromoxynil products  in containers which are smaller than 30
 gallons and which include a hard coupling designed for use with
 a specific closed mixing and loading system.

     By  specified dates, the registrant is required to develop
 and submit rabbit dermal teratology, male reproduction effects
 and worker exposure  studies to EPA.  The agreement requires the
 registrant to submit one-line, status reports on each required
 study on at least a  quarterly basis to EPA.
CONDITIONS OF CANCELLATION
     All pesticide products containing bromoxynil butyrate were
automatically canceled, effective the day following publication
of the Cancellation Order in the Federal Register.

Recall     _

     in their request for voluntarily cancellation, the Company
stated that it would institute a plan to recover remaining
stocks of these products from distributors, dealers, and users.

Existing Stocks _

     Sale, distribution and use of existing stocks of bromoxynil
butyrate product now in the possession of distributors, retailers
and end-users is not permitted after the date of publication of
the Cancellation Order in the Federal Register.  The registrant
also .indicated that they will accept for disposal any stocks of
bromoxynil butyrate products turned in by distributors, dealers
and end-users.  Persons holding existing stocks of cancelled
bromoxynil butyrate products must dispose of them in accordance
with the applicable requirements of the Resource Conservation and
Recovery Act (RCRA).  Noncompliance with the cancellation order
or its terms is a violation of FIFRA sections l2(a)(l)(A) and/or
COMPLIANCE MONITORING
Reional/State Activities
     Inspections will.be conducted by the States and EPA (in
non-grant states) to monitor compliance with the Conditional
Registration' Agreement and the Cancellation 'Order.  This will be
accomplished through registrant; producer establishment, and
marketplace inspections.  Enforcement actions regarding the
Cancellation Order will be 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

-------
                                    -4-      .          ' '

and Regions, with reports of such actions and/or potential
violations made to EPA headquarters.   States and Regions win
also report to EPA headquarters all violations or potential
violations of the conditions of registration of bromoxynil
octanoate products.

Registrant/Producer Level	
     Within 30 days of the date of this strategy, the
Regions/States will schedule and conduct inspections of Rhone-
Poulenc's producer establishments to obtain assurance that the
company has complied with the requirements of the May 5, 1989
Agreement "by not having released products for shipment without
the amended stickers, and the June 5, 1989 Cancellation Order
to determine if production and sale for distribution of
cancelled bromoxynil products within the U.S. has ceased.
Information obtained during inspections of registrants records
regarding disposition of stocks of conditionally registered and
cancelled products should be forwarded to other Regions for
their use in scheduling inspections.

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

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

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

Distributor/Reseller/Retail Level

     Within 60 days of the date of this strategy, the
Regions/States will inspect, during routine scheduled
inspections, distributors, resellers, and retailers to assure
that the registrant has adhered to the time frames and
requirements listed above under "Requirements of Conditional
Registration," and the June 5, 1989 Cancellation Order to
determine if sale and distribution of cancelled bromoxynil
butyrate products within the U.S. has ceased.

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                                    -5-            .  .

User L,evel	

     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.

Realons	
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.        "                                       0

Will distribute a list of products, and producing establishments
to the States.

Will conduct inspections in States without Cooperative
Enforcement Agreements as specified in this Strategy.

Will take enforcement action as appropriate.

-------
                                    -6-

noncompliance with the requirements of the Agreement, including
information on tips and complaints received.

Will report to the Director of the Compliance Division, OCM
regarding violations of the conditions of registrations
immediately upon receiving such information.
                  «
States	

Will conduct inspections as specified in this Strategy.

Will make quarterly reports to.the Regions detailing the number
and dates-of inspections related to this Strategy, for one year
after the date of this Strategy.

Will take enforcement action as appropriate provided they have
the authority.

Will report to the Regions on potential violations of the
bromoxynil conditional registration agreement, including
whether training and assistance activities are conducted, and
enforcement actions for violations of'the Cancellation Order.
Reports will be submitted within two weeks of Knowledge of
violation or enforcement action.

Will investigate tips and complaints as received.  If States
receive information which indicates possible noncompliance 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  12014  2  T.W.  Alexander  Drive
Research  Triangle Park, NC  27709
Product Name
~~1
Buc'tril*
EPA Reg. No.

  264-437
Broot 15GX  (Bronate)*    264-438
Buctril + Atrazine*      264-477

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

  264-OR-001



  264-OR-001

  264-IA-001
Estab. Address

Rhone-Poulenc AG Company
6200 NW St. Helens Rd.
Portland, OR  97210
                                                             Rhone-Poulenc AG Co
                                                             2100  S  21st St.
                                                             Clinton,  IA 52732
                     No USA Production Records for 1985-88
                     264-MO-001
                  Rhone-Poulenc
                  PO Box 367
                  317 West Florence Rd
                  St. Joseph, MO  64502
Buctril 4 EC'**

Certrol**
  264-474

  264-421
  264-NC-001      Rhone-Poulenc AG Company
                  T.W. Alexander Or
                  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-
Dragonmate Broad!eaf
 Herbicide**
264-339
264-MO-001
Rhone-Poulenc
PO Box 367
317 West Florence Rd
St. Joseph, MO  64502
* uonaitionai ly registereo 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.  =>4,  \'o. ill  / Monday. June  12.  1989  /  Notices
                                                                                                   24949
    Name Of KX*C«M
                             Locjuon
                                Proieo desuuvon
                                           Reviewing agency
Osteof line*
  action
Long tattnd Ughbng Co. '
! West Babylon. NY.
Nassau Oistrict Energy Corp..) unondale. NY	
Karmne Carmage Cogerwa-  j Carthage. NY	
  lion Co.. Inc.            I
Momlt Pfess Co	i Purm NY		

Kamir.e Soutn Glens FJMS   Socin Gtens FaJs.
  Cogeneration Co.. Inc.     ;  NY.

  ces. Inc.
Soise Cascade Corp	: Seever r*!s, NY....
Hoffmann La Rocfw Inc	' Setvidera, NJ	
        Inc ........................ ' Par1'?.. NJ ..„ ...... ___

Long island bglnng Co .......... S-Torenam. NY ______

Life Severs. Ice ................. : ...... ! Las Piedras. P3 .....


Aooon Laooratsriss ................. ' Sarcetoneta, PH.. ..

Mecan-aacme. Assoctites. ; Carton. NY ............
  Inc.             .     :
United Cevetocmcnt Gtouo- j Niagara Fstia,  NY...
  Niag&ra. inc.
Town of North Hempstead ; Port Was^ngton.
  SoM  Waste Managemen^j   NY.
  Aumcnry.              \
       f7/ Systems. Inc ....... kowvi;.*. NY ............
Construction of a 220 MW gas lurtxne y»ie»aliori
  factty.
Cortrucoon ol a 57 MW cogeneraton Facility	
Conjtrucaon of a So MW jaa turbine, steam gener-
  ator.
Construction of an 11 station rotogravure press and
  modricstion of an 8 smon rotogravure press.
Corsmxaon at a 50 NW gas (ureme/steam gener-
  al.
Construction of a 53 MW jat turBme.'steam gener-
  a;or.
Herxaccment of an eusdng oil-fired baler win a
  new oil-fired ooiier.

Revision of me nitrogen oxide emission limit piew
  pusly  permitted  tor a  23.3 MW cogeneraticn

Revfeon of tns  partcutsM matter emission  Urnfl
          permined for mree ooaMved balers.
           of a  220 MW gas turbine generation
  facing
ConBtrucrier of a  new steam boHerand •  new
             corwersun ot an mti"*j genere-
  tor and OoAer to standby operation.
Re-..*on of m\PM emission limit previously permit-
  ted for a ZC 2Vw cogenerawn facility.
Construction of a\l9 MW gas turbme/ steam gener-
  sior.
Construction of a coaj fired cogeneration system....
FennsajKen  Solid  A«te  PerVsr-'kei. NJ
  Managamem Autronty '.  j     \
Construction of a 990 i
  resource* recovery I

Construction of a 49 MW i
  ator.
Construction of f-»o  250
  s-M waste incirerattrs.
                                        I" ^ rnunicipal waste
                                          > turbine/steam genef-

                                             per day muniopal
NYSCEC 	
NYSCEC
NYSDEC . _ 	
NYSOEC 	 —
NYSDEC 	
NYSDEC
NYSDEC 	 - 	
SPA region II 	 _....
EPA fegion II
NYSCECs 	
EPA region 11 	
EPA region II 	 \_..
NYSCEC 	 .ii
NYSDEC 	 	
NYSDEC 	
NYSCEC.... 	 	
NJOEP 	 ..._...
PSO permit

do . 	 .
	 00 	 ,.._ 	
_"* '
PSO non-
applicability
determination.
PSD perm* revision .
da
PSD permit
approval.
PSO non-
appiicability
PSO pcnrM rwo»w.-
PSOpermil
\ approval.
\ do 	
X'™*
PSOyptatttty
dftklDnffliiMsX
PSO permit
_ do 	 J\.'.
7/18/88
10/07/88
10/19/88
I2/05/8S
12/05/88
1/09/89
1/11/39
1/17/99
1 / 1 " • 89
1/23/89
3/01/89
3/06/89
3/06.89
3/10/39
3/1S/89
. 3/20/89
4/20/89
                                                                                               i
    ' On M*y 18. '9ae. me Lo-g is^rnj L^rmng Comoar.y (LiLCO) was issued a PSD pymrl by trie New York State Department of Environmental
120 veqawan 'MWl gas 0:0 ne cocer->)Q9on ^~(^ tor "i Ae«t Barjy.on pom. The penk was not considered elective and thereiore was not :nct
Us Nov-jTioer C5. 1988 F£r?o«L P^c-.sTtn ronce on fi-n PSO acnr^s because ao-ssu6d a °iJ permiMn February 10, 1989 by tne Mew Jersey Department of
Protecti:n This .-^rmn wcoid "ave becc^v «nec'.:ve on Vi'cn 13, '939 if no pec'jon for aarrmjiratrve review was tiled wnrt tne EPA Aarmmstraior •«
C-C. Hcwcver. a oemion for review wis '*ta Syve Tawrinip ot Cinnarpmsoa tne 9orougft of Painyra and tne Bvougn of Rrverton on Marcn 7. 1989. On
198». '.19 EPA Aomk-Hstratar oectcec  d".er careful revie* of \f~9 appeal  not to grant 'urtr^r rev>«\ ttt try; petition. Therefore, me PSWMS PSO permit 3 effect
ol Apr,l 20.  198J.
                                                                                                                              lor a
    us notice lists or.iy the sources that
      received finai PSD determinations.
Anyone who wishes  to review these
detcrnWiaiior.s and related materials
should \ntact tl.s following offices:

EPA  Actions
I'nitod Stat-jj-Envirormentai Protection
   Atency. V- ,-gion il Oifice. Permits
   AJiriir.istrition Branch—Roc.r. 505. 26
   Fsci'.-.-al Pl^zd.j^'ew Yoiic. New York
NYSDEC Acuons
New York Sta!" Dppar^inent of
  Environmental CcrserVation. Division
  of Air Resources. sourc\Rev:ew and
  Re-.v«nal Siippcrt SfctionVso Wolf
 . Posd. Alb'jny. New York :\L:33-0(Xn.
        Actions
.'•'ei%  I'Tsey IK-njrtment of
  Environrr.i ntul Protection. D.\.aiNn nf
  Fnyironmcr.ieii Qisfliity. D:;reju of
  F:r.;.-.nser;nc; A Techno'lt TV 401 Er-sO
   jtate Street Trenton. New Jersey
     525.
      iLavailabie pursuant to the
   Consolidated Permit Regulations (40
   CFR P\rt 124). j'idicial review of these
   rletermitutiors under section 307(b)(l)
   of the Cle\n Air Act [the Act) ziay be
   sought or.lyyby the f:::r.g of a peti'ion for
   review in the\L'nited States Court cf
   Appeals for tnW appropriate circuit
   within 60 days ftam the date on which
   these determinatitins are published in
   the Federal Registek Under section
   307(b)(2) of ihe Act. fhcse
   determinations shall n\t be suhjcct to
   later judicial review in c\v:I or c:l.~ir.al
   proceedings for cn:orcerr\i:.

     Dated: )une 1, 1969.

   William |. Mu'iynsla,
   \'.~R Doc. S')-1.I349 Filed 6-9-38: 8 4S .ir-.f
   B:LLIKC CCCE i^co-so-u
                                                                 10PP-661M; FRL-3600-4]

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

                                                                 NUMMARY: This no ace announces EPA's
                                                                 decision to cancel all registrations
                                                                 issued under the Federal Insecticide.
                                                                 Fungicide, and Rodenticide Act (F1FRA)
                                                                 for pesticide products containing the
                                                                 butyric acid esMr of bromoxynil (3.3-
                                                                 dibromo-t-hydroxybenzoniL'-i'.e). The
                                                                 registnnt Rhone-Poulenc AC Company
                                                                 has requested voluntary cancellation of
                                                                 these products. Because of the
                                                                 developmental risks  associated with
                                                                 exposure to these products. EPA will not
                                                                 permit and the cancellation order will
                                                                 explicitly prohibit the sale, distribution.
                                                                 iuid use of existing stocks of affected
                                                                 products.

-------
24'J."0
Fedorjl  Register
             ..Ill  ,  Mor.i!,.v. L:r.
DATE: The cancellation order
incorporated in this notice will become
effective June 13. 1989.
FOR FURTHER INFORMATION CONTACT:
[u-:o Andreasen. Special Review/
  [^registration Division (H7j08C).
  Office of Pesticide Programs.
  r-;.:-. inr.mental Protection Agency. 41)1
  M Sir-ret SW . Washington. DC 20400
Offire iucatiun and telephone number:
  F>~. inooF. CM =:. l?:i Jeffprson
  D,iv;s riigh'.vay.  Arlington. VA. (70rO
  jj"-1170.
SUPPLEMENTAHY INFORMATION:

I. Request for Voluntary Cancellation
  On May 1.1989.    Rhone-
                   Po-jler.c.

                   ill. Cancellation Order

                     Effective June 1.1, I3B9. the
                   registrations for all pesticide products
                   containing the butyric acid e.^te; cf
                   bromoxynil (3.5-Jib:omo-4-
                   hydroxybenzonitrilf) are canceled
                   pursuant to section 6(f)(l) of FIFRA. 7
                   U.S.C. 136d(f)(l). Effective June 13. 1989,
                   it shall be unlawful under FIFRA section
                   12(;0(1)(A) and/or FiFRA section
                   l2(a)(2)(K). 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:
                                              Product
                                           '.. Kinjr.i 10325  !.-.:.Ti-stcJ c '•
                                         i;iy submit ccT.r'.i.T.ts t-n r:T.~.
                                         Iroomer.: to I!IP S
  EPA
registration I registration '
No.
264-339
264-340
264-340
264-340
264-3SM
264431
264.474
HO. '.
	 • QragonmatA
ME 4 Srcminal
• Torch Twin Pafc
i 3-»-3 Qfominflti
	 	 	 ; Sromoynd Sutyrate
! Technical
Certrot
3£0-'i6 Buetnl 4 EC.
I
                     This Order does not prohibit any
                   shipments of canceled products
                   containing the butyric acid ester of
                   bromoxynil which are associated with
                   the program to recover stocks of such
                   products established by Rhone-Poulenc
                   AC Company, or which  are otherwise
                   necessary to facilitate proper storage or
                   disposal of such products.
                     Dated: June S. 1969.
                   Douglai D. Caoipt,
                   Director. Office of Pesticide Programs.
                   [FR Doc. 89-13648 Filed 6-9-89: 8:45 air.)
                             MARITIME COMMISSION

                                 Filed
                     The FedcraVMaritime Commission
                   hereby gives nomeof the filing of the
                   following agreemenHfiJ pursuant to
                   section 5 of the ShippirtiAct of 1984.
                     Interested parties may inspect and
                   obtain a copy of each agreement at the
                   Washington. DC Office of the Federal
                   Maritime Commission. 1100 L Sti
                                              within 10 days jfter 'he .:
                                            pderal Register :n u;::rh :h
                                               . The reqtiin'ms.'T.ts for
                                               ,'a are four.J ;n 5 5~J.!'i'
                                               i Code of Ft:-:oral R-- -
                                                  persons should Co.'.s-
                                                    i cunirr..:",»:;!i:r.: '••>
                                                        ii:r.-' a pprni1".!
                                                   yVcJ.: 202-
                                          TYr.'i.'. Su::th\Eurcpe. l.'.S.A.
                                       Conference ("i
                                                            v.cii Esrar.
  Achille Lauro
  Compania Trasi
    S.A.
  Ccsta Container L\ne (a Divis
    Contship Containeriines Lir.;
  d'Amico Societa di .\avigaz:o:u
    S.P.A.  •          \
  Evergreen Marine Corporation
    (Taiwan) Ltd.
  Farrell Lines. Inc.
  "Italia" di N'avigazione S.^
  Jogolinija
  Jugooceanija              \
  Lykes Lines (Lykes Bros. Steiim'
    Co.. Ltd.)                 \
  A.P. Moller-Maersk Line      \
  Nedlloyd Lines (N'edllcyd Lijr.cn
  Sea-Land Service. Inc.
  P 4 O Containers (TFL). Ltd.
  Zim Israel Navigation Company.
  \nopsis: The proposed mod:fkc
would permit any member !o
disassociate itself from any Confer
actionVi a rate or service item tha
would mult in a reduction in the o
cost per cargo unit to the shipper b\
giving wrinen notice to the other
members prwr to the time the rate c
service item lias been filed with the
FMC and become effective.
  Agreement No.: 217-010738-003.
  Title: Barber Blue Sea/Open Bulk
Carriers Chartering Agreement.
  Parties:
  Wilheimsen LinesNA/S
  Open Bulk CarriersvLimited
  Synopsis: The proposed modificat
would authorize the parties to discu:
and agree upon rates, charges and a
competitive matters regarding
intermodal movements. It would alsc
permit the parties to agree upon saili
schedules, service frequency.\nd po
to be  served by each party. It would
further make other non-substantVye
administrative changes.
  Agreement No.: 232-011184-002.>
  Title: Evergreen Marine Corpora ti\
(Taiwan) Ltd. Italia di Navigazionc S

-------
            UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                        WASHINGTON. D.C. 20460
                                                          OFFICE OF
  	   •   •                                    "  FCSTICIOeS AND TOXIC SUBST.

Mr.- Nick Somma.
Rhone-Poulenc Ag. Company                                 ... _  •
P.O.- Box 12014
2 T.w. Alexander Drive
Research-Triangle Park, NC 27709

Dear Mr. Somma:

Subject:  Application for Conditional Amendment - Revised
         .Labeling/Restricted Use Classification/Data
          Requirements/Additional Conditions.
          Buctril Herbicide
          EPA Registration No. 264-437
          Bronate Herbicide
          EPA Registration No. 264-438          .     ...
          Buctril + Atrazine Herbicide
          EPA Registration No. 264-477
          Your Submission Dated May 1,  1989

     Your application dated May 1, 1989 to conditionally amend the
subject pesticide registrations to incorporate  revised  labeling,
a new classification for restricted use, additional  claims-,-and
specific conditions for continued registration  is granted,
effective immediately.  -Continued registration  of these
pesticides 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,
                                  Robert  J*:  Taylor
                                  Product Manager  (25.)
                                  Fungicide-Herbicide  Branch
                                  Registration Division (H7505C1

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DAT£i   MfiY  '  f't-L  TIM£: .  //•C«A*\  TOTAL NO,  OF PAGES
                                           (INCLUDING COVER PAGE)   75"

TD»     ejU'^   7/vsc/j-t/V	  LOCATION:  _^/» - 4'tc_/vg_/^


FAX N0»        7^J.  55-?  ^3/^>6	  SENDER)
PLEASE  ADVISE BY FACSIMILE OR PHONE IF MESSAGE  IS  NOT LEGIBLE OR ALL  PAGES
ARE NOT RECEIVED.

FACSIMILE NO, ISi
DIRECT  LINE TO TELECOMMUNICATIONS  OPERATOR IS


                                     M£SSAfi£
    TO:  Edwin  Tinsworth
        EPA
   . Attached Is the AflpJJ.catlon for Amended Registration of bromoxynll products,
"•"''It should contain  all the revisions discussed.   A copy is also being sent overnight
    mall.  If there are any questions, please let me know.
    Sincerely,

    Nick Somma
'513A
                         • <

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 RHON£-POULENC
RH6NE-POULENC AO COMPANY

                                                          May  1.  1989
     Robert  Taylor  .
     Environmental  Protection  Agency
     Office of Pesticide Programs
     Crystal  Mall, Building 2
     Arlington,  Virginia   22202
     Dear Mr. Taylor:
           SUBJECT   Buctril  (264-437),  Bronatc (264-438)
                       Buctril  4 Atrazine  (264-477)

           Rh6ne-Poulenc  Ag  Company  hereby applies to conditionally
     amend pursuant to FIFRA §3 (c) (7) (a)  the  pesticide product
     referenced above  to  incorporate the  revised  labeling, new
     classification  for  restricted  use,  additional claims, and  specific
     conditions for continued registration set  forth below.   Rh6ne Poulcnc
     hereby claims in  connection  with  this application for alienee:.
     registration  that it will.conform  to  the following  conditions as cart of
     its distribution  and sale of these products.

           The  text  for stickers which incorporates new language  adding  a
     classification  for  restricted  use,  a new  label  warning concerning .
     developmental toxicity, and specific  use directions requiring
     additional  protective  clothing and  equipment and new use practices
     is appended to  this Application  as Attachment A.. Rhone  Poulcnc
     agrees as a condition of  registration that it will •attach  the stickers
     appended  to this  Application  as  Attachment  A to- all  containers  of
     these  products  that are  released  for shipment  by Rhone-Poulenc
     after the date of approval  of this amendment by  EPA.   Rh6ne
     Poulenc further agrees as  a condition of  registration  that  it will
AC6CARCM TRIAK.CLC »•<. * C 377M

•NTERNATlOhAL TELEX NUM8E" '9903?l ANSWERBACK APC RTP
INTERNATIONAL OlSmie J'ON StBviCCC TClCX NUMOCn «8W377-ANSWe"BACK APC IOC

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                     CONDITIONAL  REGISTRATION


I.Revised Labeling
     A.What
          1.Classification
          2.Warning Label
          3.New use pracices
     B.How
          1.Stickers
               a.All stocks leaving RP after 5/5/89
               b.All stocks leaving distributors after 5/15/89
                    (1)instructions
                    '(2)enougn for all inventory by 5/25/89
          2.New permanent labels
               a.Plan by 5/22/89
               b.On products by 10/1/89
               c.states:
                    (l)deletes claims for turf and non-crop uses
                    (2)all restickering provisions
                    (3)equipment needs

11.User Training
     A.Training of users
          1.prior to 1990 spring use
          2.pending EPA  approval
     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 bulk (>30 gal) by 10/1/89
     B.Feasibility study for small  containers by 1/1/90

IV.Safety assessment data
     A.Rabbit dermal Tox--5/l/90
     B.Male repro--6/l/90
     C.Worker exposure--12/31/90

-------
 RHONE-POULENC
RHdNE-POULENC AO COMPANY
     provide  to  each distributor  holding  inventory of  these  products
     quantities of  these  stickers  sufficient  for  such inventory within  ten
     days after the date  of approval of this amendment by EPA, and  that
     Rhdne Poulenc  will  assume  responsibility  for insuring  that  each
     distributor attaches  the sticker  to  each container  of  these  products
     which  are sold or distributed  by the  distributor after the date (he
     stickers are received.   Rhdne Poulenc  further agrees as  a condition of
     registration  that  it will provide  to each reseller and  retailer holding
     inventory of  these products  quantities of  this sticker  sufficient  for
     such inventory  within  twenty days  after the  date  of  approval of  this
     amendment  by EPA. and  that  Rhdne Poulenc  will assume
     responsibility  for insuring that each  such  reseller or  retailer  attaches
     the  slicker to each  container which  is sold or distributed by the
     reseller or retailer after the  date the stickers are  received.   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-Pouienc further  agrees as a  condition of registration  that
     it will submit by May 22, 1989 a complete  copy of revised labeling
     for  subject  products  which (1)  deletes all  claims,  references, and  use
     directions pertaining to the  previously permissible uses for turf and
     nOn-crop areas,  (2)   includes all the  new  label provisions included in
     the  sticker which is appended to this  application  as  Attachment  A,
     and (3)  incorporates  the  additional  revised  labeling concerning  the
     equipment .which must be  used for mixing and loading as set forth in
     Attachment  D.  Rhone-Poulenc  -agrees as  a condition of registration
     that, after review and  approval by EPA of  the complete revised
     labeling  to  be submitted by  May 22,  1989,  such revised labeling  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
        :. TELEX NUMStM «W937»- ANKWfcM*A(.K A&C DTP
          'STH'B'J'tO*. 3£«VlC£S TClCX NJMQCB «9W3»- ANOWCnOACK APC 103

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RHONE-POULENC
RHONE POUUENC AQ COMPANY
     program  to  provide additional  training to users of  bromoxynil
     products  prior  to  the- 1990 spring use  season,  and  will  upon  approval
     by EPA  implement such a training  program.   Rhonc-Poulcnc  further
     agrees  us a  condition  of registration  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 mixing
     and loading system, and will provide to EPA a detailed  report  of its
     findings  and  conclusions no later than  January  1.  1990.  For  products
     sold  in  bulk containers;   Rhone-Poulenc  hereby applies  to  amend its
     registration for these  products  to provide, and  agrees as a  condition
     of registration, that all  bulk  containers of these products  which  are
     released  for shipment by Rlionc-Poulenc  after  October  1, 1989 will
     include  a mechanical transfer  mechanism which terminates in a drip-
     free  hard coupling which may  be  used only with a  spray or mix tank
     which has  been fitted  with  a compatible coupling.

          For each of the specific  data requirements described  below,
     Rh6ne  Poulenc agrees as a condition of registration  that it  will
     develop  and  submit the  specified  data according to  the specified
     schedule.  Rhine  Poulenc  agrees  that  failure to submit the required
     data, or  to adhere to  any element of  the  specified  schedule for
     development  and  submission  of the data, will  constitute grounds for
     cancellation  of Uiis registration  under  FIFRA $  6(e), unless  Rhdne
     Poulenc  demonstrates  that it  has undertaken in  good faith  and in  a
     timely  manner all steps necessary  to  develop  and  submit  the  data
     according 10 the  specified schedule  and that its failure to  submit the
     data  or to  adhere  to the schedule  was  due to  factors that could not
     reasonably have been  within  its control.
     Rabbit Dermal Teratology  Study
          . *•**(«* HC *

            NUMe£P«0
            JUT.CN SEBvCCS TCtCx M'jMOCf *M9W- ANCWcnaxCK xrc IDS

-------
 RH6NE-POULBNC
 RH6NE-POULENC AQ COMPANY

     Pilot:
           Submit Protocol-May 8,  1989
           EPA  Approval of Protocol by--May 23,  1989
           Study Initiation-May 31, 1989
           Study Completed-September 1,  1989
           Final  Report-October 16, 1989

     Full:
           Submit Protocol-June 1,  1989  (without dose  selection)
           EPA  Approval of Protocol by-July  15,  1989
           Discussion of Dose Selection-October  2, 1989
           EPA  Approval of Dose Selection by-October 23,  1989
           Study Initiation—November  1,  1989
           Study Completed-March  1,  1990   •
           Final Report--May 1.  1990
     Male  Reproduction  Effects Study

     Pilot:
           Submit Protocol  -June  IS,  1989
           EPA  Approval of Protocorby-July 3, 1989
           Study Initiation-July  14,  1989
           Study Completed-September 1, 1989
           Final Report-October  2,  1989

     Full:
           Submit Protocol-July  3,  1989 (without  dose  selection)
           EPA  Approval of Protocol by-August 4, 1989
           Discussion of Dose Selection-October 2, 1989
           EPA  Approval of Dose Selection-October 14, 1989
           Study Initiation--November  1,  1989
           In-Life Completed-February  1,  1.990
          Final report-June 1.  1990


     Worker  Exposure  Study

     Submit Protocol—June  15,  1989
PO SOX 12014 2TW4LFI*NnPRnHIVE
              NC 37700
iNTCRNtflOMAV UkCx NUMKR 
-------
ff RHONE-POULENC
    RHdNE-POULENC AQ COMPANY

         (Protocol  is to be  based  on scope of  study as presented in Attachment
         E)
         EPA Approval of  Protocol -August 18,  1989
         Draft Report  (Non- QA'd)--November  15,  1990
         Final Report-December  31,  1990
         The  schedules  given above are based  on  Rhone-Poulenc's expectation
         that  EPA  will respond  to the protocols  and dose selection in a timely
         manner.   If EPA does  not  provide a  full response  to a  proposed
         protocol or  proposed dose  selection by  the  date  specified for  EPA
         approval,  the  agreed schedule  may be  adjusted  to  permit an equal
         delay in  completion of subsequent steps.   However,  if EPA responds
         in  o  timely manner but is  unable  to  approve a proposed protocol or
         proposed  dose  selection by the specified date due to  substantive
         concerns  regarding  the content of  the  proposal, Rhonc-Poulcnc  agrees
         that  it will  adhere  to the  established schedule unless EPA  approves
         an extension.

         Rhone Poulenc  will  submit one-line  status reports  on each  of the
         required studies on  at  least'a quarterly basis.   The  proposed protocol
         for the  Worker  Exposure Study, will  also  describe and  require
         submission  of  appropriate  interim  reports.   In  addition  to  submission
         of these reports, Rlione-Poulenc will  immediately notify  EPA  if  any
         problems  arise which might  prevent  the  timely  completion or
         submission  of any of the  required  studies.

               Rhone Poulenc acknowledges that this ..pplic .tion f«.r
         conditional  amendment  is  based on  the Agency's  assessment  of  the
         data  concerning the risks and benefits  of  bromoxynil use available to
         EPA  as  of the  dale  of this  application.  Rhone Poulenc declares that it
         is Rhdne  Poulenc's  present intention  not  to request additional
         amendments of  this  registration during the  time required to develop
         and submit  the  data described  above.   Rhdne  Poulenc specifically
         agrees that  EPA may deny without hearing any  additional  application
         to amend  this  registration  which Rh6ne Poulenc  may  submit during
         the time  required  to develop and  submit the data required  above,  if:
         (1) EPA  determines  that Rhone-Poulenc has not submitted
         substantial new evidence which materially changes  the Agency's
    "O BO* i»u 2 TW AlEMNPS* CM'VE
    nCSCAUCH TRIANGLE P*B< NC 37709
    Old) S*9 JOOO
    INTERNATIONA^ TCICX NUM3CB 49003'! ANSWERBACK *P? DTP
    INTERNATIONAL P'STaoUWON SC/WlCES ?6»E« NJMfl£P 49003V-AKgWfcuOX* **: IOC

-------
 RH&NE-POULENC
RHdNE-POULENC AQ COMPANY

     assessment  of the  risks and benefits of use of  bromoxynil  and which
     was not available  10 cither EPA or Rhone-Poulcnc  at  the time this
     application  was  submitted and   (2) EPA  provides  a  written
     explanation of  the  basis for its determination.
     Sincerely,.
     Nick Somma
     Registration  Manager


     COPY: Mr. Edwin  Tinsworth
(9*9) $497000
INUfttMJIONAl 'tkCX NUMBED 4«Q»)?8 ANSWtBBACn 4PC ATP
                       ..C* NJMOCP *v»n ANCWCTOATK APC os

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  P/EPA
                                        0*
                                                 DC »4«fl
 Application for P«sticld«:     Registration
_ __       L& Amendment
                                                     102852
 iCompany/Produci Number
       364*477
   . Oitt
                                            fitctlon
       May  1.  1989
S Nam* «nfl Add'tu of Appi-c*fll (incite* ZIP OoSOT
                                M«n«gtr
                            Robert Taylor
4 Pfopo»«o tun ''Ci:
n
                              Rhone-Poulenc Ag Company
                              P. 0. Box  12014. 2 T. W. Alexander Drive
                              Researcn Triangle Park, NC  27709
 f*"l ChfOi K thli l»
              Bucirll  <*• Atrazme Herbicide
                                 Saetlon H - Am«ndm«nt Information
             A^^ .-..,
                                         ^ •*,
                                                                            Dei* of Letter
                                                                                  1,  1989
          Label modification to Include  Restricted Use. Classification and  additional
          label restrictions.
                                            •ectlon Ml
i. Location of Net Content* tofo'maQonjf
 nut**
n
                              r*
                            pMk«Q« wgt No.
                                 wolgM   No por eentolnor
                                                                            2 ' yp* Of CenUln«r
                                                         M*U!
                                                         PtWtic
5 locaoon of UMI Ouoeitoni

    gOnUMt
    On m«t«f/«t •coomponytng product
              •. Mannor in VVhiefl UMIM Affixed To Product
                   U*oarapl»
                                                  fV
        Nick Somna
       Registration Manager
                              919-549-2372
   I o»rtify Vt«t ««• •uiomwtd I h*«« m«d* on Alt tomt «M« *0 «iueAm«(«» ft«r«to an trw«.
   eompM*. l •oknewi*0g« tfut any knowingly falat or miaiMding »uurtw»t may b« puftiaKabia by flno or
   tmpritonmont or ooffi gndaf appKoapl* law.
CTypOdNarw
            Nick Sonina
                                                   9. TiUo
                                                     Registration Manager
                           0 Daw Signed
                             May  1.  1989
 A roiM asro-i («•». «••*) Pr»*
-------
RHOAJE— £»OLrr*EXJC
BROMOXYNIL SPECIAL LABELING COMMUNICATION PLAN
09:20;38A
Nay 1, 1989
COMMUNICATION
MEDIA
PAX
DIRECT MAIL
PERSONAL CONTACTS
STICKER PERSONAL
DELIVERY
DATA -LINE
RADIO
POINT OF PURCHASE
INFORMATION
DISSEMINATED
RESTRICTIONS/
USE DIRECTIONS
RESTRICTIONS/
USE DIRECTIONS
V
RESTRICTIONS/
USE DIRECTIONS
V
PACKAGE STICKERS
RESTRICTIONS/
USB DIRECTIONS
RESTRICTIONS
(SEE DEALER FOR
FURTHER INFORMATION)
RESTRICTIONS/
USB DIRECTIONS
TARGET
AUDIENCE
DISTRIBUTORS/
RPAC SALES/FD
DISTRIBUTORS
RESELLER/CUST APPLTR
UNIVERSITY EXTENSION
GROWERS < RESELLER MAIL)
UNIVERSITY EXTENSION -
NEED SCIENTISTS
RESELLERS
CONSULTANTS /FARM MGRS
DISTRIBUTORS
RESELLERS
GROWERS
GROWERS
GROWERS (VI A RESELLERS
PLACE OF BUSINESS)
ESTIMATED NO.
INDIVIDUALS
160
169
50
6,000
4,000
5,000
100
3,000
100
160
2,000
35,000
143,000
40,000
DELIVERY
TIME FRAME
DAY 2
DAY 5
1
V
WEEK 3
WEEK 1
WEEK 1 - 1,500
WEEK 2 - 1.500
WEEK 2
WEEK 1-2
WEEK 2-3
WEEK 3
WEEK 3
WEEK 2-3
TOTAL NUMBER CONTACTS: 23d, 739

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                                                         ONw* ol PtHiciiJ*
                                                                      -ii4, Oot»c:.s-
                                                                         sxao
^V FRtV      Application for Pesticide: U Registration
\rl-t  *m       rr	LL'Amendment
                                                                                                      10285:
                   1 . Company/Product NumOO*
                          264-438
                           Q«t
                                                                 JUfillon
                              May 1, 1989
               Applicant jlnciuo* Z/f Qo5ij
     3~ Product M»nag«r
         Robert Taylor
                   5 Ntmt «nO
                                                  Rhone-Poulenc Ag Company
                                                  P.  0. Box  12014, 2 T.  W. Alexander Drive
                                                  Research Triangle Park. NC  27709
                                  Bronate  Herbicide
                                                      flacllon It. Amandmant
n
                          P~nftn«l pi
                          '  lin"..^
                                                                                                   0«t« of L*t1«r
                                                                                                    May 1.  l?89
                             LaDel modification  to Include Restricted Use Classification  and .additional
                             label restrictions.
                                                                 ^•etlon III
                   1. M«l»fl»l TMl PfOOuCI A'lll 8* P«eK«8»fl In
                   DV   O*
                        tion o N»l Content* kife<«naiion 4.
                   i Location o» U6«i Oi'tcnoni
                                              Unit PtouQinp
                                                      TU
                         Unit popfcag* wyt  No. por o»nujn«r
                                                                               a Typ« o( Cenuif
                                                                                   Mtul
                                                                                   PUrte
                                                                                      No.
                                                                                                       Otfi.i Qf»clty)
                       On m«Mrl» •ocompanyfnQ protfu«t
                                       «. Mannor In WHich UMIM AWiatd To Product
                                                                 Stctlon IV
                     t. Contact Point »»«M«*o<>nM«yp«*>iv4»rtf*/Tt*feWbno/MtfM0t««/»o*

                                                 J2JUBBUUUU
                         Wick SOOIM
                    ^
                         Registration Manager
                     OOTipMi* I •cfcnowtodgw lh«t «ny
                     (mpntonmtnt
          t or both undtr ipp«e«M« low.
                                  M* fomi «nd
                                  («lM or
                                                    T«l«pnorw No. f*»o/«o» Xn>« Coo*»>
                                                      919-549-2372
tUt*m*nt m*y p* puni«i»«W« by fin* or
                    »8"«iu»»
                    Typ*d NvnT
                               Mick Sonnu
                                                    3 . TIM
                                                      Registration Manager
                                                     . C«M
                                                       May 1.  1989
                                              oowoni •/• oo«oi«i*

-------
.  j»'O'»
United Sl*'«l Cn»'io**^ feqo/a/n ae aetow (tor MvtHrlf ettoA o/ MdM«««a/
Nlma
N1ck Sonma
Registration Managtr
too*

Telcphon* No. (toctvd* ATM CooV/
919-549-2372
1 oortfry that th« otatamorm 1 ha*o mad* on thi» form and ad anaenmantt ftereto aro triio, aoeurata. and
oompiet*. 1 aokno««odo* tftat any knowingly falM or mldaading Matamant may bo pwnlihabl* by Una or
ImprlMnmont or both wndtt applicable law
"""" ^^^^
4. Typed Name S /
N1ck Sonma
PA f e»* e»»0-i («e». 4-aaj Pie**oy» edition* a>e obMtow.
3* *'U9
Registration Manager
5. Oat* ftioned
May 1. 1989



-------
ATTACHMENT A

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            RESTRICTED  USE  PESTICIDE
                              durs » poisons di*ajy unb** ttwir scporvison and ooty tor then* uaon o*«jr«d by t
                                                    faaaans tf IB product a cUafad Racrtaad Uta
     r-or rojuJ Mt» a and u«« only by
                  Ao*atyi ortKfcattoo
 BUCTRIL*  HERBICIDE
     THE CONTROL Or C&HTAJN 0HOAlA.CAr VYCCAV9 lr» 9MAU. UnAirQ, oCXIAJrtU ALT AUTA, VASrVl, WJWVinUM, FLAX. UARUC.
                                                    '
                                                _
                of far«jrno«yn<* (3,8 dtn'omo 4 fry i>ou'|>^*)fgoriRrl>^.
                                                                                        .33.4%
 •Bromezynll oeteneito •qu^*l*rrt to KJTk of bromoiynll or not toM th*Vt
 it) pound* ef bfomorynll per gallon. __ •      _
                          KEEP OUT OF REACH OF CHILDREN
                                   AVISO    WARNING
 PRECAUTION AL USUAHIO: Si U»t»d no 1
                                 , no u»» •«• pf oqucto h«»a quo » •Uqu>u i\iy» »Mo •Kpltc+oo
C.P.*. Bog. No. ZS4-437
                                        ^•f PBQOUCT L«E l»l«m»lla»l Cll 1 JOfl ill
                                    tUKMBMeY intomoilo* ONLY C»l»« Haul A Q«y
N*{AHM TO HUMAN* ANO DOMCino AMMACi
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                                              i* W*
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-------
                                                                                          erf
                    RESTRICTED USE  PESTICIDE
    For r«uj Mb b and u—> orly by G*tf«d AppMBas or
                                                                   n *cf only kit Doa» u»«s cowwd I*
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 BUCTRIL** Atrazine Herbicide
POSTEMERGENT HERBICIDE  FOR  CONTROL  OF CERTAIN BROAOLEAF WEEDS  IN CORN AND
SORGHUM.   _ _____
ACTIVE INOflED»6WT
  OoUnoto «oW
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-------
tor
                      RESTRICTED  USE  PESTICIDE
    For r«jj MM to «/KJ u*# only Dy C«rtff«3 Apptc o> p».-x»<» drocty v«3ox tN»» n^jojrvaon and only foi res* uMa covovoo b, ih«
                                     Sw« yirjcaolunary ttdlamen^ fe' ma^cris ihe. praOcO a
 BRONATE* Herbicide
run CONTROL Or CfeMTAJN UHUAULuir Wt_bl/3 In wnu> 1, BAH!_e~. UAT9, AMU HYfe.
ACTIVE INGREDIENT
    Ocunolc acid ••»«f ryniactana«*«
" Equ»v«i<*t to 2 V9% 2ep»Xic aod or nq tea tMn 2 0 pounds MCPA arid p»' paten _

                          KEEP OUT OF REACH OF CHILDREN

                                              WARNING
fcPA H>g. No.
                                                              EPA E«t No.
                                    for PRODUCT USE Information C«IM«eOO-W4-9745
For EMERGENCY Information
r>0>CCAUTIOHANV •TATCMfMTO

HAIAQOI TO HUMAN* AND OOMtoTIC ANHUU
wAftmNo  •toTmcTto uoi
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ATTACHMJNT B

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                  BROMOXYNIL COHTAINCR RCLABCLiNG SCHEDULE.
 FOLLOWING IS  A DETAILED  PLAN  DESIGNED  70  APPROPRIATELY RELABEL ALL BROMOXYNIL
 PRODUCT CONTAINERS  EXISTING WITHIN  THE CHANNELS Or TRADE,  INCLUDING
 RHONE-POULENC,  DISTRIBUTOR. AND  DEALER  INVENTORIES, IN A TIMLFRAME CONSISTENT
 WITH  THE APPLICATION  FOR  AMENDED  REGISTRATION.  UPON FINAL EPA APPROVAL
 THESE STEPS WILL  IMMEDIATELY  BE IMPLEMENTED:
 DAY  1  FOLLOWING. EPA AMENDED REGISTRATION APPROVAL

 RHONE-POULENC WILL INITIATE THE PRINTING OF APPROVED AMENDED LABELS
 FOR  BUCTRIL*. BUCTRIL* * ATRAZINE AND BRONATE* HERBICIDES IN SUFFICIENT
 QUANTITIES TO RELABEL ALL EXISTING BROMOXYNIL CONTAINERS HELD BY RPAC,
 DISTRIBUTORS AND RETAILERS, .AS HELL AS FUTURE PRODUCTION QUANTITIES
 SCHEDULED FOR THE REMAINDER OF 1969 USE SEASON.

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

REVISED LABELS HILL BE DELIVERED AND STICKERING OF RPAC INVENTORIES
AT PLANTS AND WAREHOUSES HILL BEGIN.  NEWLY L .) E H  IKtU '  H 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 WILL BE DIRECTLY MAILED TO DISTRIBUTOR LOCATIONS.
APPROPRIATE COMPENSATION FEES WILL BE PAID TO DISTRIBUTOR FOR RELABELING.
AND VERIFICATION OF LABEL DELIVERY HILL BE MADE BY DISTRIBUTOR SIGNING
THE "RP LABELING COMPENSATION" FORM.  MONITORING BY RPAC FIELD REPS
HILL BE PERFORMED TO INSURE COMPLIANCE.  DISTRIBUTORS HILL BE INFORMED
THAT NO BROMOXYNIL PRODUCTS MAY BE SHIPPED PRIOR TO RELABELLING ONCE
LABELS ARE RECEIVED.

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                BRONATE'/BUClRkVBUCTRJL* * ATRAZ1NE
                   RELABELING COMPENSATION PROGRAM

 THIS PROGRAM  JS DESIGNED  TO  COMPENSATE THE DISTRIBUTOR AND RESELLER
 FOR RELABELING HIS CURRENT  INVENTORIES OF BRONA1E*, BUCTRIL* AND/OR
 BUCTRJL** ATRAZINE BROADLEAF HERBICIDES  TO COMPLY WITH EPA REQUIREMENT:

 TO PERFORM THIS TASK  IN ACCORDANCE WITH SPECIFIED 'RELABELING DIRECTIONS,
 DISTRIBUTOR/RESELLER  WILL BE COMPENSATED  AT A RATE OF $0.50 PER
 CARTON, 30-GALLON DRUM, OR 1JO-GALLON MIN-I-BULK CONTAINER.

 CURRENT PHYSICAL INVENTORY AS OF 	
                                        (ITATET

               BRONATE'*    BUCTRIL*    BUCTRIL* * ATRAZINE
CASES
DRUMS
MINI'S
I HEREIN CITIFY THAT AS OF DATE SPECIFIED ABOVE, WE HAD IN OUR
INVENTORY THE QUANTITIES OF RHONE-POULENC BROMOXYNIL PRODUCTS
AS LISTED AiiOVE, AND HAVE RECEIVED ADEQUATE QUANTITIES OF REVISED
LABELS FOR RELABELING ABOVE INVENTORIES.
BUSINESS NAME:

STREET ADDRESS:
CITY:	 COUNTY:      -       STATE: 	 ZIP;
OWNER/MANAGER: 	^WTWrTW^	 PHONE:
                       (SJoNAlURE)
RHONE-POULENC REPRESENTATIVE:
                                    (SIGNATURE;          TtRR.  H

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DAY 11-20 FOLLOWING EPA AMENDED REGISTRATION APPROVAL

FIELD REPRESENTATIVES WILL INITIATE DELIVERY OF APPROPRIATE LABELS TO
EACH ACTIVELY SELLING BROMOXYNIL RESELLER, BEGINNING FIRST WITH PRIORITY
ACCOUNTS WHERE LARGE INVENTORIES ARE KNOWN TO EXIST. INSTRUCTIONS FOR
PROPER RELABELING WILL BE1 PROVIDED AND COMPENSATION MADE TO INSURE COMPLIANCE.
RESELLS WILL BE INFORMED THAT NO BROMOXYNIL 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
WILL BE MADE BY RESELLER SIGNING THE "RELABELING COMPENSATION" FORM.   •

EFFORTS TO HAND DELIVER NEW LABELS TO ALL RETAILERS WITH BROMOXYNIL
INVENTORIES WILL BE MADE, HOWEVER, MAILINGS TO MINOR BUSINESSES MAY
OCCUR TO INSURE DELIVERY IN TIMELY MANNER.  THESE MAILINGS WILL BE DONE
USING REGISTERED MAIL TO VERIFY LABEL DELIVERY.
DAT 20 FOLLOWING EPA AMENDED REGISTRATION APPROVAL

LABEL DELIVERY FOR BROMOXYNIL FIELD INVENTORIES WILL BE COMPLETE AND
MONITORING BY RPAC FIELD REPRESENTATIVES WILL CONTINUE, TO.INSURE ALL
CONTAINERS PROPERLY LABELED FOR SALE.

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                                ATTACHMENT A

                   0UCTRIL*.  BUCTRIl* « ATRAZ1NE. BRONATE*
                            RELABELING PROCEDURE
 2*-GALLO* JUG

 1.  DEPALLETI2E 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.

 6.  PEEL BACKING FROM NEW PRODUCT LABEL AND PLACE NEW LABEL COMPLETELY
    OVER EXISTING LABEL ON THE JUG.                                   •
                                                  o

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

 6.  FOLD DOWN THE TWO SMALL FLAPS OF CARTON AND FOLLOW WITH TWO LARGE
    /LAPS.

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

10. REPALLETIZE CARTONS IF NECESSARY INCLUDING RESTRETCH WRAPPING IF
    AVAILABLE.
       c

3O-6ALLO*  DRUM AND MO-GALLON MINI-BULK

PEIL BACKING FROM NEW PRODUCT LABEL AND POSITION NEW LABEL OVER THE
EXISTING LABEL ON CITHER THE 30-GALLOW DRUM OR 1)0 MINI-BULK CONTAINER.

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ATTACHMENT C

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ff RH&NE-POULENC
                   AO COMPANY


    OFFICE MEMORANDUM


     TO:     Nick Somjna      .              DATE:   May J, 1989

     FROM:   Dave Downing


         Please find attached the Bromoxynil  Label Amendment Communication
     Plan.  Our goal '1$ to reach all  persons  who sell, apply or recommend
     bromoxyntl products within the agricultural community in an orderly,
     logical and timely manner.  With this  1n 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 Information
     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 EPA approval.  Resellers
     will be contacted on a priority  basis  according to their past sales
     volumes as recorded by Rh6ne-Poulenc.

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

         Rhone-Poulenc feels that this 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.
     DPO:vwg
     Attachment
     cc:     J.N. Harton
             S.A. Schmotzer

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                BROHOXYNIl LABEL AMENDMENT COMMUNICATION  PLAN
 UPON RECEIVING FINAL APPROVAL FROM THE  EPA  OF  1989  LABCL AMENDMENTS
 FOR  COMMERCIAL BROMOXYNJL  OCTANOATE FORMULATIONS, AND APPROVED COPY
 OF INTENDED INDUSTRY COMMUNICATIONS.  RPAC WILL IMMEDIATELY INITIATE
 A COMPREHENSIVE PLAN TO DISSEMINATE NEW PRODUCT PRECAUTIONS AND RESTRICTIONS
 TO APPROPRIATE AUDIENCES WITHIN  THE PESTICIDE  CUSTOMER/USER NETWORK.
 FOLLOWING  IS-A DETAILED DESCRIPTION AND TIMETABLE OF HOW THAT PLAN WILL
 UNFOLD:
PAY  1 FOLLOWING  EPA  APPROVAL  OF COPY

COMPLETE LABEL AMENDMENTS. WITH A COVER  LETTER HIGHLIGHTING EACH PRECAUTION
AND  RESTRICTION  OF THE BROMOXYNIL LABEL, AS WELL AS A DESCRIPTION OF
THE  PRODUCT RELABELING PLAN,  WILL BE TELEFAXED TO EACH DISTRICT AND
REGIONAL OFFICE.  WITHIN RHON£-POULENC AG  COMPANY.

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

ANNOUNCEMENT OF THE BROMOXYNIL LABEL CHANGES AND THE PRODUCT RELABELING
PLAN WILL BE SENT. VIA OVERNIGHT MAIL TO ALL BROMOXYNIL DISTRIBUTORS.

RPAC FIELD SALES PERSONNEL WILL BEGIN MAKING PERSONAL CONTACT CALLS
ON BROMOXYNIL DISTRIBUTORS AND RESELLERS GIVING CONTACT PRIORITY TO
THOSE RETAILERS REPRESENTING THE MAJORITY OF BROMOXYNIL SALES TO GROWERS.
IN ADDITION RPAC FIELD DEVELOPMENT REPRESENTATIVES WILL BEGIN CONTACTING
UNIVERSITY EXTENSION PERSONNEL AND WEED SCIENTISTS.  AN ESTIMATED 3.000
TOTAL CONTACTS CAN BE MADE WITHIN TWO WEEKS.

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DAY 5 FOLLOWING EPA APPROVAL OP COPY

DIRECT MAJL LETTERS OUTLINING THE 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.
DAY 14 FOLLOWING EPA APPROVAL OF COPY

"RESTRICTED-USE" CLASSIFICATION OF BROMOXYNIL HERBICIDES WILL BE COMMUNICATED
TO SOME 35,000 GROWERS THROUGHOUT HIGH INTENSITY USE-AREAS, VIA DATA-LINE,
A COMPUTERIZED INFORMATIONAL SYSTEM, WITH COPY THAT INSTRUCTS GROWER
TO SEEK DETAILED LABEL USE AND HANDLING PRECAUTIONARY INFORMATION THROUGH
THEIR AG CHEMICAL SUPPLIER.

DIRECT MAIL LETTERS OUTLINING THE LABEL AMENDMENTS AND NEW RESTRICTIONS
WILL BE SENT TO FARM MANAGERS AND CROP CONSULTANTS.

PRINTING OF POINT-OF-PURCHASE POSTERS WILL BE COMPLETED AND SENT TO
RESELLERS. TO BE DISPLAYED AT THE RETAILER LOCATION TO ALERT GROWERS .
HHO'PURCHASE BUCTRIL*. BUCTRlL* «• 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* + ATRAZINE AND BRONATE* AND VO  Ni'.Ul . U
-------
                            DEALER/DISTRIBUTOR LETTER
 ATTCKTIOK - LABEL CHANGES FOR BRONATE*.  BUCTRJL* AND BUCTRIL* * ATRAZINE
 This  1s to  Inform  you  that  BRONATE*.  BUCTRJL*  end  BUCTRJL* * Atrazlne
 broadleaf herbicides  have  recently  been  reclasslfled  as "RESTRICTED USE
 PESTICIDES"   and  that  the  labels   have  been amended   to  Include  new
 precautionary statements, additional protective clothing  requirements, and
 new handling  and application restrictions.

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

 Enclosed you will .find copies of  each  new label for your review.   Please
 take  time to  become'familiar with this Information In order that you are 1n
 full   compliance with each  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 In
 a single day; 4) Use  of  enclosed cabs when applying  180 or more acres 1n a
 single day; and  5) New chemlgellon and aerial application  restrictions.

 In  an effort to  assure .that  all  Inventories  of  BRONATE*.  BUCTRIl* and
 BUCTR2L* + Atrazlne are  stlckered with these changes,  a  relabelling-program
 1s  being Implemented  by  RhSne-Poulenc and within the  next  several days your
 RP   Field  Representative   will   be  delivering  adequate  quantities  of
 self-adhesive  labels   with  Instructions  for  relabelling  your  current
 Inventories.    To  perform  this  task  Rhfine-Poulenc will  compensate  your
 efforts  at  a  rate  of SO.SO/case. 30-gallon drum or no-gallon  mini-bulk
 unit,  and will verify  your participation with  an enrollment form at time of
 label  delivery.   In addition, your  RPAC Field Rep  will provide  Resellers
with  a  polnt-of-purchase  poster  for  hanging,  and   grower handouts,  both
alerting him to  the label  changes  of  which he mist comply.

Once  you have received  revised labels,  no product  may  be shipped  or sold
until  stlckered  with  the  new label.  If for any reason distributors.don't
receive  labels  within  7  days  of receipt of  this  letter  (14 days  for
Retailers),   please   call   tne   toll   free   Rhfine-Poulence   Hot-Line  at
l-BOO-334-9745.  and labels will be  lowedlately shipped to you.

Thank  you  for  your   continued   support  and  help  In  communicating  this
information.   Please  contact your  RPAC Field Representative 1f you  have
Questions or  specific  Issues relating to this matter  that  you would like to
discuss.

                                       Sincerely,

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                        UNIVERSITY/CROP CONSULTANT LETTER
ATTENTION - LABEL CHANGES FOR BRONATE*-, BUCTRIL* AND BUCTRll* * ATRAZINE
Th1i  1*  to  Inform you  that  BRONATC«,  BUCTRIl*  and BUCTRR*- * Atrazlne
broadleaf  herbicides  have  recently  been reclasslfied as  'RESTRICTED  USE
PESTICIDES"   and   that  the  labels  have  been  amended  to  Include  new
precautionary  statements, additional  protective clothing  requirements,  and
MM handling and application restrictions.

These  changes have  been  implemented because  recent  tests  have shown that
exposure  to  the  active  ingredient  in  these products  has  caused  birth
defects in laboratory  animals.  The new label  amendments have been added to
substantially  reduce  the  exposure   to  these  products when  handling  or
•pplying.

Enclosed you  will  find copies  of each new label for your  review.   Please
take time to become familiar with  this information  in order that you are 1n
full  compliance  with  tach  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 mechanical  transfer systems when  handling  30 gallons or more product In
a single day;  4}  Use of enclosed  cabs when applying 180 or more acres 1n a
single day; and 5)  New chemigation and aerial application restrictions.

Thank  you  for  your  continued support  and  help  in communicating  this
Information.   Please  contact  your RPAC  Field Representative 1f you have
questions or specific  issues relating to  this  matter that you would like to
discuss.
           i
                                       SI ace-rely.

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             GROWER LETTER TO BE AVAILABLE AT RESELLER LOCATION

 RH6NE-POULENC    _^_____
f f£mf^^^m*m*mmf**t*^*t**f**^f*^*^*j*f***^^****^*^^^i^fmil**'**********^*^^**m^^f^*m^mm^^m


 HM6NI.POULINC AQ COMPANY



               TO: BUCTRIL»/BUCTRIL« «•  Atrazine/BRONATE*  Users
   BUCTRIL*.  BUCTRJL*  +  Atrazine  and  BRONATE*  herbicides  have  been
   reclassified  "Restricted   Use  Pesticides",   and   additional   label
   restrictions  and  precautions  have   been  added  to  minimize  user
   exposure.   " '-'

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

      *    Warning  Statement: This product has  been shown to  cause  birth
          defects   \r\  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,
          co.tton   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  Rhone-Poulenc  Ag
  Company.
03 BOX 190U ? TW A>,.ri(AMXR DRIVE
BtKABCwt«iANSi.E»AB* NC 27706
(919) 149-MOO
MTEflSATiONAl. TElEX NUM««»4»W3»»-
                                               °c IOS

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               RADIO/DATA-LINE COPY
ATTENTION GROWERS!
                             i

BUCTRll*,  BUCTRIL* «•  ATRAZINE  AND BRONATE* HERBICIDES/
USED  FOR PO£T-EMCRGENCE  BROADLEAF  WEED CONTROL/  HAVE
               *
BEEN RE-CLASSIFIED AS RESTRICTED USE PESTICIDES.
FOR COMPLETE  DETAILS  AND INFORMATION/ CONTACT YOUR FARH
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.

-------
       POS1ER FOR RESELLER
      BUCTRIL'
     BRONATE •
              1
 BUCTRIL* + ATRAZINE
       ARE NOW
RESTRICTED USE PESTICIDES
 ASK HERE FOR COMPLETE
 DETAILS AND INFORMATION,
 RHONE-POULENC AQ COMPANY

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                          ATTACHMENT D
In lieu of the sentence which states, "If this product is
packaged in a 30 gallon drum or you will hor.-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 ox, mor« of this produce 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, ycu 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 compatible coupling.  If
you do not presently own or have access to a mechanical transfer
system with this type of coupling, contact your dealer for
information on how.to obtain such a system or to modify your
present system."

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ATTACHMENT  E

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                                                         APR 2 5


     DRAFT   PROPOSED PROTOCOL:   BROMOXYNIL  EXPOSURE STUDY



 1.0   INTRODUCTION '

       A passive  doeinetry  study shall be  conducted to ••seas th«
 dermal and inhalation exposure  occurring  during routina  uaa of
 broooxynil.   The atudy •hall  be designed  so that the
 Environmental Protection Agency may be able to:  (1) quantify the
 exposure occurring during  nixing/loading, application, and clean-
 up when brcBoxynil is applied by ground boom to field crops
 employing rigs where boom  lengths typically exceed 50';  (2)
 quantify the  exposure occurring during mixing/loading,
 application,  and clean-up  when  broaoxynil is applied by  ground
 boon  to crops where  rigs of 20'  to 40' predominate? (3)  within
 each  subgroup estimate the total potential  dermal exposure and
 the actual deposition ta the  skin under the clothing worn by each
 study participant.   As an  additional objective, this study or a
 seperate study will  quantify  the potential  dermal exposure and
 •Kin  deposition  occurring  during open pour  aixing and loading
 with  the new  Rhone-Poulenc 2.5  gallon container and a
 conventional  2.5 gallon container.

 2.0   MATERIALS AND METHODS

       2.1 Sits  Selection

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

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

2.2  Cooperator  Selection             		 ._

       Cooperators used in  the study are to be individuals
intending to  apply a post  emergent herbicide independent of
possible participation in  the study.  The candidates are to be
•elected  in a  Banner identical  to that employed in the May 6
 Baker  canada/Rhone-Poulenc Study with the exception that a
ainimua  number of participants  with enclosed tractor cabs shall
be required.   The questionnaire  used should be similar to that
used  in  the Canadian study.   Selected cooperator* will receive

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                             -  a  -

broaoxynil  in  a  Banner  identical to a non-cooparator who vould b«
obtaining bromoxynil  for  bi»/her use except that broaoxynil aav
ba providad in a non-standard  containar aa necaatary to
effectuate  the study.   Rhona-Poulanc say provide elaan coveralls
and  nitrila gloves  to study  participants.  Tha atudy participants
will initially ba instructed to  follow label direction*.  Should
tha participant  attampt to handla broaoxynil with last than tha
label required prottctive clothing, Rhona-Poulenc will record
such deviation froa the label  directions and then require the
participant to .utilize  all required clothing.  The normal and
typical work routines of  the participants are not to be altered
once the-study participant has begun handling broaoxynil during
the aonitoring portion  of the  study.

2.3  Application Details

      Information collected  for each application of bronoxynil
shall include  target  crop, data  involving cultivar, growth stage,
date of planting, and row spacing.  Equipment information shall
include sprayer  aodel snd make, tractor model snd make, procedure
and time required to  mix  and load the -sprayer and the date and
method of aprayer calibration.  Alterations to the equipment such
as shielding of  booas and opening of windows in closed cab
tractors will  be recorded.   Application rate and amount of active
ingredient  handled  shall  be  recorded as will the actual tiae of
application.

      Field conditions  including wind speed and direction,
relative humidity,  rainfall, temperature, and cloud cover shall
be recorded at each aonitoring site for the duration of each
monitoring  period.  A description of each tast site will ba
recorded.

2.4  Deraal  Exposure

      Dermal exposure to  ell body areas with the exception of the
hands will  ba  monitored in a manner that will permit the
estiaation  of  potential damal exposure and dermal exposure to
the skin.   Potential  dermal  exposure will be monitored by the
Durham-Wolfe patch  method (Measurement of Exposure of Workers to
Pesticides,  lull. Hid Hlth Or?., 1962, 26:75-91).  Patches shall
ba placed in a manner specified in Subdivision U of the Agency's
Pesticide Assessment  Guidelines on tha outside of the
cooperator'• clothing.  Dermal exposure to body areas covered by
clothing shall ba monitored  using either whole body dosimeters
composed of a  long  sleeve cotton T-shirt and long legged cotton
underpants  or  by a  fluorescent tracer technique.  The whole body
dosimeters,  if selected,  vill  be provided to each cooperator by
Rhona-Poulenc  at laast  ena day prior to the study and shall be
placed en each eeoperator, by  the cooperator, at the time that
tha cooperator gets dressed  to perform the day's work routine.
The) whole body dosimeters are  to ba worn under all clothing

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                             - 3  -

 normally worn by the coeperators.   Facial  exposure nay b«
 monitored by the use of facial swabbing  in lieu  of dosimeter*.
 Hand exposure will be aonitbred  by  use of  hand rinses.

       The monitoring period will consist of the  handling of  not
 less than 19 lb» ac.tive ingredient  with the exception that
 external patchea will be changed and hand  rinses will be
 conducted at the end of each six/load cycle and  each application
 cycle.

 2.5   Inhalation Exposure

       Inhalation exposure will be aonitored by use of personal
 •lr  samplers.   The air saaplers  will be turned off during each
 break in the work routine likely to exceed 30 minutes.  The
 duration of  the sampling period  should be  the entire day's work
 routine; however,  caution oust be taken to prevent breakthrough
 from saturation of the collection aedia.   The duration of
 sampling and calibration of air  flow will  be conducted for each
 •ample period.

 3,6   REPLICATIONS

      A  replicate is defined as  one aonitoring period consisting
 of the handling of at least 15 Ibs  active  ingredient.  The
 residue  levels  of external patches  for each body area and hand
 rinses will  be  combined in the calculation  of total potential
 daily exposure  for each job function and the combined nixing,
 loading,  and application functions.  For each crop grouping a
 minimum  of ten  sites are to be selected.   For each erop grouping
 • •minimum of 20 replicates shall be monitored.   Per each set of
 20 replicates,  a minimum of 7, but  no more  than  13 replicates,
 •hall involve application from enclosed tractor  cabs.  A total of
 at least 40  mixer/loader/applicator replications will be
 conducted for the  study.   Monitoring of the exposure resulting
 from the use of the new 2.5 gallon  container may be conducted
 either as an ancillary portion of the study or as a separate
 study and must  consist of a minimum of 15 replications of the new
 2.5 gallon container .and 15 replications involving a conventional
 2.5 gallon container.   Each set of  15 replications will involve a
minimum  of fiva individuals at three different sites.  A
 raplicata for this portion of  the study is defined as one
mix/load cycle  in  vhicfc • spray tank is filled to capacity.
3.7  QUALITY A£SU*AKCZ

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

3.0  DATA ANALYSIS

      The purpose* of this study are to quantify the exposure

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                            • 4 -

received during the use of broaoxynil and the identification of
regulatory option* that »ay be required to reduce expoeure.

      The data will b« presented a* a aean exposure and « rang*.
The standard deviation will also be determined.  Non-parametric
or other appropriate statistics say be employed to determine the
statistical significance of different variables in determining
exposure.  Major emphasis will be placed on tractor type, bo.os
size, and tank site.  Post priori analyses Bay be conducted on
other variables depending on observed patterns in the data.   A
priori statistical tests will.be defined in the protocol by the
Agency.
A priori statistical method* will test the following null
hypotheses: 1) Exposure during nixing/loading with standard 2.5
gallon containers is the same as with the new 2.5 gallon
containers; 2) Exposure during application involving snail rigs
is the same as those involving large rigs; and 3) Exposure during
application from open tractors is the ease as froo enclosed
tractor cabs.  Any post priori statistical analysis will be
determined upon receipt and assessment'of the data.  The Ageney
fully recognizes the fact that sxposurs data is inherently highly
variable (C.v. > 100%) and that identification of variables
having statistical significance at p < 0.05 say not occur without
requiring an even greater number of replications.  Such an
undertaking would be prohibitive in cost.  Trend analysis of the
data aay bs conducted in the absence of statistical significance.

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             UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

      •                  WASHINGTON. D.C. 20460
     ^
                                                           OFFICE OF
                                                   PESTICIDES AND TOXIC SUBSTANCE
                          JUL I  3 198T


MEMORANDUM

SUBJECT:  Compliance Strategy for the Cancellatio
          of Carbon Tetrachloride

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

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

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

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

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


Attachments

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                            ADDRESSEES
I


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

Jake Mackenzie
Western Regional Compliance Director

A. Charles Lincoln
Eastern Regional Compliance Director

Louis F. Git to, Director
Air Management Division

Barbara Metzger, Director
Environmental  Services Div.
Ill  Stephen R.  Wassersug, Director
     Hazardous Waste Management Div.

IV   Winston A.  Smith, Director
     Air, Pest.  & Toxic Mgmt Div.

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

VI   William B.  Hathaway,  Director
     Air, Pesticides & Toxics Div.

VII  William A.  Spratlin,  Director
     Ai r & Toxics Division

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

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

X    Gary O'Neal, Director
     Ai r & Toxic Hi vi sion
Gerald M.  Levy, Chief
Office of  Pesticides & Toxic Sub,
Ernest Regna, Chief
Pesticides & Toxics Sub.  Bra

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 & Toxics Branch

                                    Anita Frankel, Chief
                                    Pesticides X Toxic Subs.  Branch
cc:  Jim Lamb
               (TS-788)

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

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

     Carbon tetrachloride was present as an active  ingredient
in pesticide products  registered for use as fumigants on  stored
grain, in flour  milling and grain processing plants,  as  well  as
on encased  museum specimens in storage.   All registrations  for
pesticide products containing carbon tetrachloride  as an  active
ingredient, except for  use on encased museum specimens,  have
now been cancel 1ed.

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

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

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                              -2-
REQUIREMENTS OF THE RULE
     All  pesticide products  containing  carbon  tetrachloride,
except for use on encased museum  specimens,  were  cancelled
thirty days after publication  of  the  NOIC  or the  date  of
receipt of the Notice by the registrant,  whichever  date was
1ater.

Regulated Industry	

     All  registrants, producers,  distributors,  and  users  of
carbon tetrachloride other than  those with products  registered
for use on encased museum specimens.   At  the time of the  ori-
ginal  Data Call-in, there were 52 registrants  and 114  registra-
tions.  Vulcan Formula 72 (EPA Registration  Number  5382-2)  is
the only  product registered  for  use on  encased museum  specimens.

     Carbon tetrachloride is also known as perch!oromethane
and tetrachloromethane.

Existing  Stocks	

     Previous regulatory action  has already  prohibited regis-
trants and retailers from distributing, selling,  offering for
sale,  holding for sale,  shipping, delivering shipment, or
receiving and (having so received)  delivering  or  offering to
deliver carbon tetrachloride after  December  31, 1985.
Additionally, all provisions for  use, except use  on  encased
museum specimens, have been  prohibited since June 30,  1986.
Therefore, the November  12,  1986  NOIC provides for  no  additional
existing  stocks or use provisions.   Noncompliance with the
carbon tetrachloride cancellation order is a violation of FIFRA
§§12(a)(l)(A) and 12(a)(2)(K).
COMPLIANCE MONITORING	

     Compliance with the Cancellation Order will  be determined
by inspection of registrants and producers of cancelled products,
inspections of dealers and users, and investigation of tips and
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 Compii a nee Monitoring
0 Will develop and transmit the Compliance Monitoring Strategy
  to the Regions.

0 Will transmit the list of those products which have been
  cancelled to the Regions.

0 Will transmit the list of registrants and producing establish'
  ments of carbon tetrachloride.
Regi ons
0 Will  provide copies of the Compliance Monitoring Strategy to
  States.

0 Will  distribute a list of products,  registrants and producing•
  establishments to the States.

0 Will  conduct inspections in States without Cooperative
  Enforcement Agreements as part of their routine inspectional
  schedule.

0 Will  take enforcement action as appropriate.


States	

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

0 Will  take enfocement action as appropriate provided they have
  the authority.

0 Will  report to the Regions on  actions taken under the carbon
  tetrachloride cancellation.

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                            ATTACHMENT


          CARBON TETRACHLORIDE REGISTRANTS AND PRODUCTS


                           REGION I (1)

Uniroyal Chem. Co.
74 Amity Rd.
Bethany, CT 06525
EPA Reg. No.  : 400-192,-193,-197,-200,-203,-268
                          REGION II (3)
Rochester Midland
Box 1515
Rochester, NY 14603
EPA Reg. No. :  527-11

Prentiss Drug & Chem. Co.
21 Vernon St. C.B. 2000
Floral Park, NY 11001
EPA Reg. No. :  655-624

Bernard Sirotta Co., Inc.
67 35th St.
Brooklyn, NY 11232
EPA Reg. No. :  2826-1

                          REGION III (0)

                          REGION IV (11)

Lester Labs
2370 Lawrence St.
Atlanta, GA 30344
EPA Reg. No. :  337-16

Hil.l 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.
Orexel  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,DC38000100

Big F Insecticides, Inc.
Box 3346
Jackson, TN 38303
EPA Reg. No. :  33161-2

Mid America Chem.  Co.
P. 0. Box 490
Montrose, AL 36559
EPA Reg. No. :  36480-47,-48,-49,-50,-51

                           REGION V (5)

Riverdale Chem. Co.
220 E.  17th St.
Chic. Heights,  IL  60411
EPA Reg. No. :  228-8

Dow Chemical USA
P. 0. Box 1706
Midland, MI 48640
EPA Reg. No. :  464-32,-34,-97,-171,-181,-188,-193 ,-216 ,-227

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                               -3-
Walter Haertel Co.
8719 Lyndale Ave So.
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

Weevil-Cide Co. a subs,  of  Research  Products  Co.
411 N. 7th  St.- Box 1057
Salina, KS  67401
EPA Reg. No. :  1629-1

Knox Chem.  Co.
7625 Page Blvd.
St. Louis,  MO 63133
EPA Reg. No. :  1645-12

Farmland Industries Inc.
P. 0.  Box 7305
Kansas City, MO 64116
EPA Reg. No. :  1990-116,-184,-392,KS-83000400

Patterson Green-Up Co.  Div  of  Curry  Cartwright,  Inc
1400 Union  Ave.
Kansas City, MO 64101
EPA Reg. No. :  2169-92

PBI/Gordon  Corporation
1217 W. 12th St.- P. 0.  Box  4090
Kansas City, MO 64101
EPA Reg. No. :  2217-108

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                               • J "•

The Huge Company, Inc.
7625 Page Ave.
St. Louis, MO 63133
EPA Reg. No.  : 2270-5

Research Products Co.
Box 1057
Salina, KS 67401
EPA Reg. No.  : 2548-3,-13,-22,-30,-48

Chemi.  Sol Chem. and Sales Co.
P. 0. Box 1485
Hutchison, KS
EPA Reg. No.  : 2618-2

Brayton Chem. Inc.
P. 0. Box 437
West Burlington, IA 52655
EPA Reg. No.  : 2993-7,-14,-23

Ferguson Fumigants, Inc.
93 Ford Lane
Hazlewood, MO 63042
EPA Reg. No.  : 3886-13,-18,-136

Stewart Sanitary Supply  Co., Ltd
P. 0. Box 15061
St. Louis, MO 63110
EPA Reg. No.  : 43954-6

Kaw Valley, Inc.
1801 S. 2nd St.
Leavenworth, KS 66048
EPA Reg. No.  : 44215-58,-59,-60 ,-61,-62

                         REGION VIII  (3)

Lystad  Inc.
Box 1718
Grand Forks, ND 58201
EPA Reg. No.  : 2881-21

FalIs Chemi cals Inc.
P. 0. Box 2345
Great Falls, MT 59403
EPA Reg. No.  : 40831-21

Morgro  Chen, 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-

                          REGIQN  IX  (5)

Stauffer Chem.  Co.
1200 S. 47th St.
Richmond, CA 94804
EPA Reg. No. :  476-537,-1112,-1113,-1543

Hockwald Chem., Div.  of Oxford  Chem.
275 Valley Dr.
Bri sbane, CA 94005
EPA Reg. No. :  1111-132

Coyne Chem.  Co.
999 Anderson Dr., Suite 140
San Rafael ,  CA  94901
EPA Reg. No. :  3050-23

Cardinal Chem.  Co.
Green and Sansome Streets
San Francisco,  CA 94111
EPA Reg. No. :  5440-6,-20,-22

Siskiyou County Dept. of Agriculture
525 S. 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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        UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                       WASHINGTON. D.C.  20460
                            JAN 15 1976
                                                    OFFICE OF ENFORCEMENT
SUBJECT:  Enforcement of Administrator's Decision and
            Order Suspending Most Uses of Hep.tachlor 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 Velsi-col
Chemical Corporation, et al., FIFRA Docket No.  384) ordered the
suspension or 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'consLL'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
*  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.
                                                       •

 II.  CURRENT AGENCY ACTIVITY    		.._..!...._..

       The office of the Hearing Clerk is preparing to serve by :
 certified mail copies of the Final Order on all parties to the suspen-
 sion proceeding.  In addition, the Registration Division is preparing /
 to notify all registrants by letter of their status under the Order and
 of what label amendments,  if any,  are necessary for  them to continue
 the registration of their products in accordance with the Order.

 III.  ENFORCEMENT
       The Pesticides Enforcement Division is preparing a general
 strategy to enforce the Administrator's Order.  This strategy will
 provide status of registrants vis a vis the cancellation and suspension
 proceedings,  lists of formulatorjand distributors of chlordane and
 heptachlor products, and status of product uses as clarified by any
'subsequent Orders.

       Pending the completion of this strategy, regions should pro-
 ceed with normal surveillance and inspection activities relating to
 chlordane  and heptachlor products. Enforcement actions should await
 official notice of ^suspension to subject registrants.  •

       Until that time you may find it helpful to deal with general
 inquiries as follows.

             1) So far as FED is  able to determine at this time, stoc
 of prodiigi-S— intgadgfj jQE_sn£ngiirig^3— ILS&S v/hich were formulated after
         975. are illegal for  furt^v gh-j^^c,^*| g,.i^ ^r,,ejj.
            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 vdth directions
provided by the Office of Solid Waste Management.   Disposal questions
may be referred to Ray Kreuger in Washington at (202) 755-8050. Regional
offices should cooperate in every way possible with responsible efforts to
dispose of suspended chlordane /heptachlor stocks.

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

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

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



                             jAfi-re.1976
                                                        «
                                                    OFFICE OF ENFORCEMENT
SUBJECT: Clurl'lcr.!.:..:: of Heptachlor/Chlordane
           Suspension Order

TO:       Enforcement Division Directors
           Pesticide Branch Chiefs

FROM:    A. E. Conroyn,  Director                ii/ (
           Pesticides Enforcement Division (EN-342) ff^1^


    Please find attached a copy of the Administrator's "Clarification
of Order of December 24, 1975 (In re Velsicol Chemical Corooration
et al., FIFRA Docket No. 384), " dated January 19, 1975. Although   •
the Administrator did not adopt per se Respondent EPA's proposed
order and table for clarification (see my January 15th memorandum
and enclosures), this document makes patent that all registrations
(Federal and State) of pesticide products containing heptachlor and
chlordane for uses not specifically continued (as set forth in paragraph
4 of the Conclusion to the December 24th Decision) were suspended.
For purposes of  enforcement,  "Attachment A" will be used as the
list of uses not suspended.

    Should questions  arise concerning the Clarification, or any other
matter relating to the heptachlor/chlordane proceedings, please con-
tact the appropriate regional coordinator.

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                " UNITED  STATES  OF AMERICA
               ENVIRONMENTAL  PROTECTION AGENCY
                  BEFORE  THE  ADMINISTRATOR
i«itKi>1  Chemical Corporation
  c ^ jtjj.*
                Rfiqistrants.
                              .FIFRA  Docket No.  384
             CLARIFICATION OF .
        ORDER OF DECEMBER 24, 1975
                                  ....
Chemical  Corporation; counsel for the Pineapple Growers
   of Hawaii  and the Attorney General and Department  of
                                                                                  ^* *'.
                                                                                  *v>
                                                                                  t*'r.
     C*> January 7, 1975, Respondent  EPA filed-a Suggestion for — ----   '•
purification of the Order of  December  24, 1975, in the above-
                     •                        *     "          •
u,-f. i".cd proceeding, seeking  clarification of  the uses of
•rt-i.-cts containing heptachlor and chlordane for which
                                                                                  fV.-r'
**•:' Order.  Respondent also submitted a Proposed Order, including
i-\ «'.ucfvr,cnt setting forth a  proposed  list of  uses not suspended,
'i-;?:f.cr with certain explanatory notes.                     '
   .  On January 13, 1976, I 'issued a notice of  the filing of
''••scnJcnt's Suggestion for Clarification  and Proposed Order
••••* f^isstcd  written- conments from the parties, thereby
                                                                                ' •••>»*.
          my intention to consider the possible need for      "                 fe"
                                                                          £/.•
             of the December 24. Decision and  Order.*  Oi   . "                      .-
                                                                                 U*-% -
       15( 1976, 'written comments were received  from counsel  for                C-V-.
                                                                                 f.-.
                                                                                 r

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                               2                   '  ••                   ••
 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
 Environmental  Defense Fund, oppose Respondent's suggested
                                   •                              •          • •
 clarification  of the December 24 Order, both on grounds that the
               •         '                                  '   •       '              F
 Administrator  lacks jurisdiction or authority to clarify, modify,                {•
                                                              '-.'•••     •   f
 or alter the .Order .ajid. .that. .the.. Order Js_f inal.-and. ca.nnot.now-.be. . - —'.  ,  ..    r
                                                    .-•'•-.                -I
 chanced .in the canner proposed by Respondent.       •         •    .'               j
      Even though not expressly provided for in the Rules of
 Practice governing expedited hearings under the FIFP»A, I have
.determined that authority does exist to clarify the Decesnber 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 atbuhdance of caution and concern,"therefore,
 I believe proper administration of the Decision and Order vniV.be
    •                                                     ?       *  - "
 served and facilitated by the following clarification of the..
                         •  •••     •          ••-      .    ••..«•    'v.
 December 24 Order.           .        .                 •     •„£...  "

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               .  '  -               3-                                 .           '   •   '
         In reviewing the Decision and Order and the possible need              .
  '.for'clarification, I-have not considered any new eviu'eiiCis or       •   .   v
    argumentation.   I have sought only to discern any possible"source'       .     '.   .
    or sources of any lack of clarity in the expression of my         . . •      '.  .    j
  •                         m                                       .         • *         i
    intentions at the tima I  issued the Decision and Order.  Comments          .       !
    received from the parties have been most helpful- in determining            •     i
    •whether or not  my intentions v.-ore 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 Decision   •                !
           .                        -                                *'..••'
    and Order.     •        -.    •   '    •    '      ..         '••*•'•.             !
                                "        '        *                •      ".'•''     i
         The December 24  Order, by its terms, provides that all                  .     ;
 '.  pesticide products containing heptachlor or chlordane for use         • '   .  .   ,
    (1) on corn pests, (2) on household, garden, lawn, and turf pests                 j
    (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                 i
    further provides  that any stocks of technical grade heptachlor  ...      ..     |
             "         .                    '              •              :•'"'.  V.I
    or* chlordane formulated into products intended for such uses            .    .     [
    [after July 29, 1975] may not be placed in commerce, sold, or used    '            I
    for such purposes or  any  other purpose not specifically     '  •      .       .     J
  • ;exempted [in the  November'^18; 1974, cancellation order] or_              -'       ;*
    specifically permitted in •accordance v/ith the Decision of the  •      •            •
                 1                   .    .                               •     •  .       •»
  •'  Administrator attached thereto. .                      . »                          i
                                                                                     t
                                                                                    -—
                                                                                  •• I
                                                                                   • I
                                                                                 •'• -r— —

-------
     .Ths uses specifically permitted or continued by the
 Decision accompanying 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
 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 hcptachlor or chlordass are  •
 suspended.  Because th-2 words "intended for such uses" in line 12
 of the Order might be interpreted as limiting the suspended, uses
 to the four uses enumerated in the first sentence of the Order,
 the v/ords "intended for such uses" are hereby deleted from the
 Dec.eir.ber 24 Order.      .        •  ''  '                 •
      The reasons for the specific enumeration of four uses   •
'suspended in the first sentence of the Order, while suspending uses
 for "any other purpose" in blanket form in the second sentence, are
 twofold:  (1) other than an occasional reference to certain
 fruits and vegetables and other miscellaneous crops, the record
•(including the Recommended Decision.of the Administrative Law
 Judge) does not adequately address many other (presumably minor).
 uses of heptachlor and-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
    Uccision of the Administrator, p. 76
                     -.  •  .    •...••'-•:«-. •.•  •'  .• i\-.. .;•••.• ;••;•'    •..-:'    •  •       •        ,i

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



Order nro ?.ino;ir t1' usos ns to which  sufficient benefits evidence

                 .           '        •

was presented at the hearing to permit a risk-benefit asse§sr,iont.
                                •                              •


Itlankot suspension of uses as to which there  was  little or no



evidence on benefits was necessary because the evidence on



carcinogenicUy risk v/as applicable to all uses.   In view  of the



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

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



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

                •   •               '         '     •

indicated above) they could not bs enumerated specifically in the



Order. . '    '      .     -        '.- "        .       "            •  •

 •

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



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



Conclusions in the  Decision], it was my intention, that the 	
                     •                        •         •  •     •


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



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



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



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



on  benefits  was insufficient to permit the kind of discussion of



the risk-benefit assessment which I had used for better documented
                    •      .                                    •
            •  .                 ^*-             *

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



    tame ultimate conclusion as discussed above concerning uses for.
      •-.  •        ..     ••'  •.•.•-.-...•.•• •.- «•..    •      ••. • •  •••      •••
          •*• •        .        •'•-.''

           of the  Administrator, p. 76.

-------
 "any other  purpose"  generally, i.e. that, in vicv/ of'the        %

 evidence on carcinogenicity risk, and in the absence  of  sufficient

 benefits evidence, these uses are suspended, even though they "
      •                               •    •                        •
 could not be enumerated specifically in the Order.  Thus, there is

 no inconsistency bstv/aen paragraph  5 of the Conclusions in the
                                  •                             "
•Decision and the provisions of the,Order.
      In view of the foregoing, I do not find  it. necessary to
     «                               •              •
 either-adopt or- peaect .-the .Proposed-JOities. subnu±tfiil_b^.R£S.patiKldnt*
                                                                                   \"
                                 B
                                 t
                                               .1
Russell i. Train
 Dated:  January 19,  1976
                                                                                   t.t
                                                                                   • •"•
                                                                                     l
                                                                                   •  t
                         '/.: ' ' •'"• ' '.  • '
                         ' '•""*'*:• .'•."'.':•*• '  ' •

-------
                                  ATTACHMENT A
                     •"•'  '                 1
                         SPECIFIC USES   or cm.onnANv: ^ m:PTAcni.on
                     NOT SUSPENDED UY AUMIWSTHATOU'S OUDlill OF 12/24/75
  COMPOUND^)
                   USEle)
                                                                   -STATUS OF USE(s)
             •            .                                         .
  chlordnne &         Subsurface ground insertion for termite control       continued
,  heptachlor •
•  chlordane &
  hcptachlor
                     Dipping of roots or tops of non food plants
                                                            2
                                                   continued
I
  chlordane &
         '4
  hcptachlor
 Control of cutworms on corn (both pfe and post

 emergence)                  '            '
                                                                      continued until

                                                                      8/1 /7G only
  heptachlor
 Control of narcissus bulb fly
                                                                      continued
'.hcptachlor
                     Seed treatment
                                                           .
                                                   continued
.- heptachlor—
           »'
• Ant control lb ach'ieVe pineapple" mealy bug"
                  5
 control in Hawaii
                                                                       continued
                                                                         »•.
 t
  chlordane
 In Federal /State quarantine programs for
                6                .5.6
 Japanese Beetle  and imported fire ant
                                                                       continued
  »
  i
  dilordane
 Control of black vine weevil on Japanese Yew
 in Michigan
                                                                       continued
  chlordanc
 Control of Texas harvester ant in Oklahoma
                                                                       continued
  chlordane
 Control of imported fire ant by private
            5.7
 individuals
                                                                       continued
. . chlordane
' Control of white fringed beetle attacking food

 crops   In 8S.E. States CAL.FL.GA.LA.MS.NC.
 SC, TN)
                                                                       continued
 .[.
.•I
                                                                                                •r
  dilordane
 Control of soil insects  attacking Florida citrus
                                                                      continued
  'chlordane
 Control of strawberry root pests by pre-plant        continued
 treatments
  chlordane
 Control of white trrubs in Michigan
                                                                       continued
  1*  All registrations (Federal and state) 01 pcsucioe products containing hcpiaclilor ana
      chlordane for uses not specifically continued are suspended by the Administrator's
      Decision and Order on the Suspension of Hcptachlor-Chlordanc.. The effect of the
      Order is'to further prohibit the manufacture, formulation or reformulation of products
  :  ' . containing Heptachlor or Chlordane -for any purpose other than for those registered
     • uses which have been exempted in the Order and for manufacturing uses as an
    . Interim step in the. ullimate.formulalion for. such registered uses. Sale and use of .
 '.     existing stocks'ofrcgistcrcd''products which \vcrc formulated prior to July 30, 1975
      arc permitted' for both continued and suspended uses. ...... ------ ™ :"      •
 •2.'  PR Notice 74-11  (39 FR 41296) exempted this, use from cancellation.  Such use
      was similarly exempted from the Notice of Intention to Suspend. 40 FR 344SC
      (7/29/75).               .                                   ...
  3.  Clarified at 40 FR 30522 (7/21/75) to apply to the use of emulsifiablc or oil
      concentrate formulations  for controlling subterranean termites on-structural
     .cites such as buildings, houses, barns, and sheds, using current control
      practices.    t                            .                         .r
  4*  Velsicol has represented  that it would voluntarily suspend domestic shipments
      of hcptnchlor for this use pending resolution of the cancellation proceedings.
  5.  On the assumption that Mi rex is not available.  •'
  0.  To include treatments required to certify to pest. free conditions aa well as for
  -  •  use in suppression and control programs.    .-• •        •  —• -----  ___
  ?•  To include use on both public and private property by cither owner, agent.
      employee. .or contractor.        .    "  .    v '•'•-. ;.'•. ••-.•'   '".,       •
  8.  Not intended to preclude use on cotton* However;, uco oh 'tobacco is suspended.
  9.  Restricted to citrus root weevils. •    ':  -!".          "' .
                                                                             ^
                                                                             f€
                                                                             r-

                                                                            f
                                                                             r;
                                                                            i
                                                                             !.
                                                                             \:
                                                                             k

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 •» »-» «£
 ^i/7 ?   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                         WASHINGTON. D.C. 20460
                                   9 1976

                                                     • -OFttfiE OF ENFORCEMENT
SUBJECT:   Strips Report on tne Hcptachlor/Chlordane Suspension

TO:         Enforcement Division Directors
             Pesticides Branch Chiefs

FROM:      A.  E. Conroy n.  Director         f\G
             Pesticides Enforcement Division   I/V  /
    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_be 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.                       '  .-                           •      •
                            •* •:•'<„•" »•  '.^ -••  •
                 ..••"••  •   • • • •'••**"'• "''.j.-  ..'•. :•-.• ..

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                 \
i'^V^ ?   UHITEO STATES ENVIRONMENTAL PROTECTION AGENCY

        r                      WASHINGTON. D.C.  20460
     CERTIFIED MAIL
     Gentlemen:

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

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   7 ?   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.  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 haveibeen^Mocked^outv"- 'The'granting by-the Agency of such
  a petition will pieralt^ypu^p^c&ntinue^fpnwlation and/or sale of Hepta-
  chlor and/or Chiofdaner-fpr'exempte'd usesV" 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:
            »•—   .   • •  -.- • •  •    -f ~ -.-••• -. .--
            .  • .-•    .  .' -• -" • ••«"••" • : ** **"*i.'"C '* •• '
          •  • '   ."*- •• • ..".; *.• • •« - r-»'*'-:- .-'^T.V**»-.rr~ •'•- •"*-' •• :
     > • . •** • ' •.- .*•. -    -• . * .-••"••.-.., ^ .»-. . ;*^iv» «.-..•! *«.-..-•
      .-'  . ;-..-. •:•.,. ':• &:: #''-~ '?
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               A""
               1 1  .
           UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                   .                                         •  . .
                            WASHINGTON. D.C. 20450  " '
  ' CERTIFIED MAIL

   Gentlemen:       .  •           •

   Subject   :  Notice of Suspension for:
   This  is to notify you that on December 24,  1975,  the Administrator
   issued his- Decision and Order on the suspension of Chlordane and
   Heptachlor.            '    ••  .       ,.:  •     .   .  •  •.    ^ •  •

   This  document provides that all uses of Chlordane and Heptachlor are
  .. suspended except those set forth on the enclosure. Your subject regis-
 .  tration was suspended effective December 24,  1975.                    '

   As stipulated in the Administrator's Notice of Intent to Suspend, issued
•'  on July 29, 1975, the product under this registration may  not be formu-
  • lated, shipped, sold orjused after July 29; 1975..     ••        :

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


   Sihcerely'yours, :
    John B.  Ritch, Jr.  •.   -  =..
    Director
    Registration Division (^1-567).

    Enclosure  ,    .      "
                         *

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              It is  sufficient to send a cover letter with  an  air-sr.ded  label or  lab
              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 must be received
              within 30 days of receipt of this letter at the  following address:  .

                                     Mr; Timothy A. Gardner
                                     Product Manager (15)           •     •.-•••
                                  •   Registration Division  (WH-567)
                                   .  Environmental Protection  Agency
                                     Washington, O.C.  20460.
              The amendment^wJlljiQt Abxc^a£e_y^
             "nonsuspended uses in the continuing cancellation proceeding.
              Existing stocks of EPA registered pesticides containing Heptachlor or
              Chlordane may be distributed and sold for suspended uses only if the
              stocks were formulated prior to July 30, 1975.  This date was stipulated
              in the Administrator's Notice of Intent to Suspend, issued on July 29,
              1975.  Stocks of Heptachlor or Chlordane formulated after July 29, 1975,
              may only be distributed and sold for those exempted uses included in tha
              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 epp
              of your amended label.                                  .
                   *

              The Administrator's Decision and Order will be published in the Federal
              Register in the near future.
              *                                                  *    *

              Sincerely yours,              '..'.•       '•'••*      '"
              John B. Ritch, Jr.
              Director
              Registration Division (WH-5677

              Enclosure  •           •
— .r ...... — •.-.-•>- ••••  •   ••••  ••   »-.•       •  • •  •••.*  ••••.- v ..... •"••'!•»•"
  .V   ••   .'.'  :•' ..    .••     . .   '...      ••-«.   . .*   ••'••« • •• ' ••
                                       . t  r ' '  *           .
                                                                                     ,.er.

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                        SPECIFIC USES  OF CIILORDANK / I!rTTACl
                \ '  NOT SUSt'EKDED BY ADMINISTRATOR1:: Oi'.iJlJil OF 12/2-1/75
COMrOUND(s)
Chlordane &
• heptachlor
chlordane k
heplachlor
chlortianc &
4
heplachlor
4
hcptachlor
•' heptachlor
. beptachlor
USE(s)
Subsurface ground insertion for tcrmile control
z
Dipping of roots or tops of non food plants
Control of cutv.-orzns on corn (both pre and post
emergence)
Control of narcissus bulb fly
Seed treatment* *
Ant control to achieve pineapple mealy bug
control in Hawaii
STATUS OK USE(s)
Z.3
continued
•
«. .*
continued
•
. continued until
8/1/76 only
continued
continued
continued
•
chlordane
                In Federal/State quarantine programs for
                               6                     5.6
                Japanese Beetle  and imported fire ant
continued
chlordane
                Control of black vine weevil on Japanese Yew        continued
                in Michigan	'    	
chlordane
               'Control of Texas harvester ant in Oklahoma
continued
chlordane
                Control of imported fire ant by private
                           5.7
                Individuals
continued
chlordane
                Control of white fringed beetle attacking food
                      8                              •
                crops   in 6 S.E. States (AL.FL.GA.LA.MS.NC.
                SC. TN)
continued
chloi-dane
                Control of soil insects  attacking Florida citrus     continued
chlordane
                Control of strawberry root pests by pre-plant     .   continued
                treatments
chlortianc
                Control of white grubs "in Michiean
continued
 All registrations licocrai anc Mate) oj pesticide products containing ncpiacnlor and
 chlordane for uses not specifically continued arc suspended by the Administrator's
 Decision and Order on the Suspension of Heptachlor-Chlordane.  The effect of the
 Order is to further prohibit the manufacture* formulation or reformulation of products
 containing Heptachlor or Chlordane for any purpose other than for those registered
 uses which have been exempted in the Order and for manufacturing uses as an
 Interim step in the ultimate formulation for such registered uses. Sale and use of
 existing stocks of registered products which v/erc formulated prior to July 30,  1975
 are permitted for both continued and suspended uses.                 '  •
 PR Notice 74-11 (39  FR 412?3) exempted this use from cancellation.  Such use'  -
,was similarly exempted from the Notice of intention to Suspend, 40 FR 34456
 "(7/29/75)..'   -.  ---.v:  .   .                                                    '  '
 Clarified at 40 FR 30522 (7/21/75) to apply to the use of cmulsifiable or oil
 concentrate formulations for controlling subterranean termites on structural
 filtco such as buildings, houses, barns, and sheds, using current control        .
 practices.                                                 !.
 Velaicol has represented lliat it would voluntarily su.-.pcnd domestic shipments
4.
    of heptachlor for this use. pending resolution of the cancellation proceedings.
 5.  On the assumption that Mir ex is not available.
 6.  To include treatments required to certify to pest free conditions as well as for
    use in suppression and control programs.  '"
 7.  To include use on both public and private property by cither owner,  agent.
    employee, or contractor.'     .                      .                      •
 8. • Not intended to preclude use on cotton.  However, use on tobacco is suspended. •
 9.  Jtestrictcd tojcilrus root weevils. ,.                    ..             .-••;.    :

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                      '

                                              "li  '.  ..
                                                .•.    • «••:
           '.'  •     •   -Mr.  Timothy A. Gardner            •*'•.'
   .     ..:    ... '       Product Manager (15)             ' %   '. "•': ' '   '
              .;        Registration Division (WH-567)         '   '   .  •'
         . •    ."   '•     Environmental Protection Agency       .
                        Vteshington, D.C.  20460.      •        ]     •

The  amendment v/ill  not abrogate your right to defend both suspended or
nonsuspendsd uses. in the continuing cancellation proceeding.

Existing  stocks of EPA registered pesti-cides containing Heptachlor or
..Chlordane jiia., .b£_ distrJ buted,
 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  the
 enclosure and under labels containing no suspended uses-  Stocks which
 you may presently have on hand, if manufactured or formulated after
 July- 29, 1975, may not be shipped or sold until you receive  EPA approval
 of your amended label.       ..  '            ...     '      . ...: _______ '-•  -

 The Administrator's Decision and Order will be published in  the Federal
 Register in the near future.  . •  -•      ••
                            •                           •

 Sincerely yours »    '  '   .     ,'.?. . ' ;V ,
 John B. Ritch, Jr.      '  .  .
 Director         .    .''.'''•
 Registration Division (WH-567)
                       >   .
 _  , •            .'..'••-.   ...*.
 Enclosure             • • *     •
        .  •   •  • . • %   . •  . ;   .
      •*••.:••• .;.'• A:*-. »-.•=. v.  „
      .   : •- ••'.••!;"••' «i.rv--.-  .'
       «     .-.     .
                                                                1
          , . ; _ •:;'    . •'• •'.
         •" '  • • . • '• .•-••" ••''

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kS22 *   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
\^   4/          .;        WASHINGTON. D.C.  20460
                 \*


                              2 3 MAR 1976
                                                     OFFICE OF ENFORCEMENT
    SUBJECT: Heptachlor/Chlordane Suspension Order
               Enforcement Strategy

    TO:.    - , Enforcement Division-Dir^ctors-—.'-.-	
               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 12/24/73TT"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 heptr.cMor or chlordane products formulated
         g/ter July 20,  1975 may be sold, distributed, or used
         only for exempted uses, as per "Attachment A".


 n.  CATEGORIES OF HEPTACHLOR /CHLORDANE PRODUCTS '     _ •_..-v±LI

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

     (A) Federally registered products, all uses of which have been     -~   _
 susp'ehded. The Registration Division/Office of Pesticide Programs
 has notified, by certified mail, all affected registrants that their prod-  .'  .
 ucts have been finally suspended by the December 24th Order. 1 /  An
 example of a product in this category would be a product register ed    	
 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/chlor dane products have been pro- .
 duced.
                      *
     (B) Federally registered products, some uses of which have been	
 suspended As noted in the introduction and in previous memoranda,   r
 there is a large category of registered products whose uses were sus-
 pended in part by the December 24th Order, but whose sale and distri-
 bution may continue upon ["provisional"] 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
 i/ see my * ebruary 19, 1976 memorandum entitled "Status Report on the
"TTeptachlor / Chlor dane Suspension. " and its attachments.

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                            -3-
 registrants of 140 "intrastate11 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 •ca.teTgoryof~r egvstrants~c«> Lu ~tl.ic.u~ pi-uduuly'••-it'atusr™"~
 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 29th--those
that chose to continue formulation despite the Notice of Intent
to Suspend did so at their own risk.  The Agency wants to ensure
that the pesticide producing industry does not interpret a Notice
of Intent to Suspend as a signal to increase production of the subject
product during the pendency of the suspension proceeding.

    It has been the general policy of the Agency to request national
recall where product registrations have been suspended in order
to prevent an imminent hazard to man or.his environment.  That
policy will be applied in the instant case.r As the initial step in  ....
implementing this  policy, EPA has requested the recall,  down to
and including the retail level, of all heptachlor/chlordane products
for which all uses  were suspended and which were formulated
after  July 29, 1975 [category A products].  In addition, the Agency
intends  to request  the recall—in some instances fox* relabeling--of
all heptachlor/chlordane products formulated after July 29, 1975

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                            -4-
 whose labels contain both suspended and non-suspended uses [category
 B products].  "Intrastate" products [category C products] will be treated
 in a manner consistent with similarily situated Federally registered
 products.


 IV.  ENFORCEMENT ACTIONS.                	•

     As has been the established policy in such matters, enforcement  "
 actions will be taken, in accordance with normal procedures and at
 levels consistent jwith 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 .-.L-.U:
 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   ~r—••
 resources which would be involved in-conducting a formal recall, -the-••-••
 Agency feels that the procedures outlined in the Case Proceedings      |
 Manual,  Chapter 12, for informal recalls would be more appropriate
 in this matter.  Information and guidance with respect to  specific en-
 forcement related actions which may be directed toward each of the
 aforementioned categories of heptachlor/chlordane products follows: .:..-

     (A) Federally registered products, all uses of which were sus-
 pended and which were formulated alter July 29, 1975.  As per recall ~~"
 initiation procedures, the Pesticide Enforcement Division has notified
 by certified mail those registrants who had all uses of their heptachlor/
 chlordane product(s) suspended by the December 24th Order, that EPA
 is requesting that all subject products formulated after July 29, 1975;.
•be recalled immediately.  This letter,-..a.copy of which is attached to-
 this memorandum, refers the addressee, to the Registration Division
 suspension letter  informing the registrant of the registration status of
 his product(s), and continues by specifically requesting that (a) the .,.-.
 company initiate procedures to determine the locations of all quantities-
 of their finally suspended product and the amount of such product at
 each such product location, (b) that the product be returned to the
 registrant from all locations, and (c) that the named regional  contact
 person be informed of all actions taken in connection with the recall.

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

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

            (i)  disposed of the product.

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                               -5-


            (11)   exported product in accordance with section 17, or  2/

            (ill)  sought new registration for continued uses;

        (3) stop sale any such product found in consumer channels
            under section 13; and

        (4) where appropriate, initiate enforcement action under
            section 14.  3/              ........
                       M^M  f

    (B) Federally registered products with both suspended and con-
'tihu'e'd uses and which were "formulated after July 29,  1975.  As soon
as these products can be  identified as to their registration status,  FED
•-win- request ^a^h-registrttnt-toncotttaclraH, kuowTrdtstrltruturtf;' whoTg-—
salers, and retailers that the subject product  should not be sold or
otherwise distributed.  Registrants will be instructed that they should .
recall from retail level as set forth above for category A products.

When following-up to determine compliance with the recall of these pro-
ducts, you should:

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

            (i)   disposed of product if amendment to labeling is not
                 made,

            (ii)   exported product in accordance with section 17,

            (ill)  relabeled product with amended label deleting sus-
                 pended uses,  or      --	          .

            (iv)  in accordance with EPA approved instructions,
                 overlaid product  with approved sticker labels.
                 masked  out suspended uses,  or used other means to
                 delete suspended uses from the labels;
 Z/  Registrants: should be informed -thafthe Agency would interpose
 no objection to the export of products affected .by. the suspension order,
 but wishes to caution, registrants concerning the recent stipulation
 signed by the Department of State concerning the utilization of US funds
 for USAID procurements of such products.  See USAID regulation entitled
 "Pest Management Program,  Interim Pesticide Procedures, " published
 in the Federal Register on January 7, 1976.

 3/  Those persons who distribute or sell a suspended heptachlor/
 chlordane product in violation of the terms of the December 24th
 Suspension Order will be in violation of section 12(a)(l)(A) for non-
 registration, as well as section 12(a)(2)(J) for violation of a section
 6 suspension, order.                        .       " ~-  k  •
                                                                        t —
                                                                       .. rr

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                               -6-
        (2) stop sale any such product found in consumer channels
            under section 13; and

        (3) where appropriate,  will initiate enforcement action under
            section 14.  3/

     (C) Intrastate products.  The policies outlined above will also
 apply,  as appropriate, to intrastate products as they become identified.
 At present, the 48 products thus far identified will be treated the same-
,as JE^erally,j,e^^ieeed.pcod««tSr-'aili^
 [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,- inspectionsy-enf-orcement actions,--and	i
 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 apprisedvthat they may arrange with the appropriate regions
•to ship the product :for disposal, including return to a supplier, for
 export, or in. accordance with directions provided by.the Office of
 Solid Waste Management. Disposal questions may be referred to
 Mr. Ray Kreugeri Operations Divison, Office of Pesticide' Programs
 [(202) 755-8050]. Regional offices are encouraged to cooperate in every
 way possible with responsible efforts to dispose of suspended heptachlor/
 chlordane stocks.

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                                            - 7 -
               •

             VI.  INDEMNITIES

                 The Office of Enforcement has been advised by th-? -Office of
             General Counsel that the registrants of heptachlor/chlordane products
             suspended by the December 24th Order are not eligible for indemni-
             fication under section 15 of the amended FIFRA.


             VIE.  INQUIRES

                 Should you have any questions concerning any facet of this memor-
             andum and the heptachlor/chlordane suspension order, please contact. .
             the appropriate regional coordinator. -Questions relating to registration
             and label status should be referred to Mr. Tim Gardner, Registration -
             Vm. ATTACHMENTS           ________ -._-..-.•
.71
                 Please find attached the following:

 !                   (1)  "Attachment A — Specific Uses of Chlordane and
                       -. Heptachlor Not Suspended by Administrator ' s Order  —
 |                       of 12 724/75 .""""

 I                   (2)  Copies of recall request-letters sent-to registrants by
 I                       FED.

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

 i                   (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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  -at*"*'**1.
 S"   f*.
1
 *~~  i
Ss5g? i=    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
     ^                   WASHINGTON, D.C. 20460
                        27AUG1976
                                                       OFFICE OF ENFORCEMENT
   TO:     Enforcement Division Directors
           Pesticides Branch Chiefs

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

   RE:     Heptachlor/Chlordane Suspension Or\ier
           Enforcement Strategy — CORN USE


        Some confusion  has arisen concerning the enforcement response
   to certain heptachlor/chlordane products 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-
   Chlordanej,  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 required to implement alternative
        cutworm control methods,  the use of heptachlor and chlordane
        to control cutworm on corn crops should be permitted during
        the 1976 corn growing season.  Accordingly, I have concluded
        that the registration for use of heptachlor and chlordane to
        control cutworms on corn crops  should be suspended effective
        August 1, 1976. j*/

        As you are aware, the Administrator's heptachlor/chlordane orders
   provide the following concerning the legal status of the various products:
        */  See also, "Clarification of Order of December 24, 1975," 41
   Fed."Keg. 7552 (February 19,  1976).

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                             -2-

      1.  With the exception of the corn use. all registrations of pesticide
 products containing heptachlor and chlordane for uses not specifically
 continued (e. g., chlordane to control black vine weevil on Japanese yew
 in Michigan), were suspended as of December 24, 1975. *»/

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

      3.  Stocks of heptachlor or chlordane products formulated after     ..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 violatingthe December 24
 suspension order until this product became finally suspended on August 1,
 1976.

     You will remember that prior to our request for the recall of violative
 heptachlor/chlordane products. Registration Division, Office of Pesticide
 Programs advised affected registrants that if amended labeling which deleted
 all reference to suspended uses was  submitted and approved by EPA, the
 relabeled product could  continue in commerce.  To accomodate those pro-
 ducers of agricultural products listing  corn uses, a decision was made to
 allow the registrant to continue to display the directions for use on corn,
 provided the following disclaimer was inserted immediately after the crop
 designation: "USE SUSPENDED EFFECTIVE AUGUST 1, 1976. " Ten com-
 panies exercised their option to relabel accordingly; the 19  products are as
 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 th"e 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    A7.DEX CrlLORDANE 8E
2&35-131    RED TCP CHLORDANE 8 SPRAY
9859-51     CHLORDANE 10 GRANULAR
9859-53    CHLORDANE 5 GRANULAR
9859-55    CHLORDANE 25 GRANULAR
'14775       CHLORDANE-TOXAPHENE BAIT NO. 11 (Florida "intrastate"
            —Asgrow Florida Company,  P. O. Drawer D, Plant City, FL)

     Therefore, after Jjecember 24, 1975, no product produced after July 29,
1975 for corn use could be legally distributed or sold without the  above men-
tioned disclaimer.  The detection of such violative product will continue to
receive Agency response  in the form of a FIFRA section 13(a) Stop Sale,  Use
or Removal Order and section  14 action, as appropriate.  It is the Office of
Enforcement view that enforcement action,  including SSURO's, should not be
taken against the sale and distribution  after August 1, 1976  of products bearing
the disclaimer.  The use  of such product on corn after August 1, 1976 is in vio-
lation of the suspension order [§12(a)(2)(J)J, as well as a misuse [§12(a)(2)(G)J.

    • To summarize:  (1) products formulated  prior to July 30, 1975, includ-
ing those with directions for use on corn, may continue to be sold, distributed,
and used;  (2) products formulated after July 29, 1975, m?/  ne sold, distri-
buted,  and used only with labeling amended to include only continued uses;
and (3) products formulated after July  29, 1975, with directions for use on
corn, must bear the following disclaimer immediately after the corn use
directions: "USE SUSPENDED  EFFECTIVE AUGUST 1, 1976."

     The Agency is not  contemplating at this time the recall of the above
products for relabeling  to delete reference to  corn uses.  At the  conclusion
of the cancellation proceeding,  heptachlor/chlordane labels will be revised
to conform with the Administrator's final order.

     All inquiries in this  matter should be referred to the appropriate regional
coordinator.

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>,t\.:  T   l.T'i': .~.J 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 1C76 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 Defense
     Fund v.  EPA, No. 76-1247 (D.C. Cir., decided Nov. 10,  197b)). 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 bo routine except in the erne of firms revising to rr.-cnll.
Additional visits to producers and/or distributors may ,5e necessary
to assure compliance in these situations.  Regarding enforcement
actions,  pending a final outcome on the issue of the remand, the fol-
lowing should be pursued.  Any suspended hcptachlor/chlordane pro-
duct produced after July 29,  1975,  and remaining in commerce should
be stop saled.  Additionally, since all but retail distributors should .
have been notified to. return the violative products, any suspended  - '
products found in channels of trade above the retail level should be
sampled  and civil penalty actions issued to the distributor and/or the
producer, as appropriate. Civil penalty actions should also be issued
for any violative samples previously collected above the retail level.
Beyond stop sale,-decisions on-t-he level«of'action'to-"berapplieid"'atthe-^	
retail level are left,io 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 ENVIROrifJlcNTAL PROTECTION .'••'".'. • ;CY
'v ' /;f') tr<" *"•''. ''•'
     * •    . £
Y
                                      120CT  1976
          Mr.
          Executive Director
        x  Chemical 3p.?ciiilti3C?
            Asaocifition; Incorporated
       v  10'Jl  Connecticut Avenue,  N.
        .  Suite 1120
        •  Washington, •;. C.  20036

          Deer  Hr. Ur.qel:

               Your letter of 7»uguct  30,  1976, hsu boon  referrad. to
        •'•  this  office £or rev-ly*-  ^.eco.use of. tue Adr:.inistrator' s
          OMooin-j  rule in the chlordan -r/heyuscnlor prccesciinus,  it  (
          would *:2'improper under the Agency's rules of  practice
          for him  to respond to your  inquiry.
                     *                •                  •             •*
          •t    Your letter asks that  the  Acnsiniotratof invoke the '. .
          "special rult"/untter ^15(b)(n), in orcier to allow inven-
          tories of chloro'ane products  foraiulstod bctvrc-^n  July 29,. ;
          1<.'75,  and DucemUer 24, 197!>,  end currently on  asalor
          shelves, to be eold until such  fctocks- ore exhausted.
                                      *                            »•  .
       /•••'•                                                 '•
        .       Your  request would-necessitato' wo.Jlif iciticn o£ the
          order  issued by the Administrator on !)ceei?.oer  24> 1975.
          Requests for such wcdifications must be wade in  cont'ornancc
          with  the roles of practice  set  forth in 40 CFR Part 164.
          S«"f especially 40 Ci'K Io4.6(b), concerning 'enlarcieiT,cnt o£
        •fillno oeriotlsj 40'.CFU Iti4,31,  concerninq intervention;
        .anJS 40 CT»v IG^'.llO, concerning  wo.cicns for reconsideration
        •'of orders.             •      .
  ,v
                                    CONCURRENCES
 S.1XAMI ^  /

 DAH
                                                                OFFICIAL i-lLE COF

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    t
                             - 2 -
      Finally,  candor requires that I infant) you  that -the
Aqency  statf  would oppose any cucn .notion  to  itiotJify trie* .
.suspension  order,  snould one in fact.be filed.   Essentially,
t.his  is because  the suspension order in a  temporary order,
which ultimately will be sucerceded. l.-y an  order  qt the
termination of the cancellation proceeCinq. .The question
of  the  extent' to which distrionticn ol! existing  stocks ot
cJn''f>i'onr,-2 protects should be allowed can and  should bo
a'Jc.rossed  in  the cancellation proc^eui'rxj,  and resolved in
the order at  ths conclusion of that proceeding.   Sound  •
• considerations of  procedural nian&goratsnt militate against
interruption  of  the cancellation proceeding to consider •
this  question  at this time.      t

  :                      • •*  '   Sincerel'/r-^..
                               G. William Prick
                               General 'Counsel   (A-130)
                                V
                                                                •• i

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                        / pru|im^
                        I IxfvNLiuLiO
                         VJ/J..X*'' inmnxo nu
CHEMICAL SPrCIALTIES MANUFACTURERS ASSOCIATION. INCORPORATED
        CXCGUJr.1 w'i r.r • SIP'E HSU • «UCICOHNtCTlCUtAV£..N.W.WAS»«NClON. D.C. ?003C • (?02)«rMM10
      August 30, 1976
      Hr. R;:ssell E. Train
      Administrator, EPA            .    •  •   .  :      '   .
      •401 M Street, S.W. .  Room W1200                   .
      Washington, D.C. 20460        .          .'
                                    •
      Dear Mr. Train:         _      -   -         *.''"'

      On August 16, CSMA counsel Robert Ackerly and  Roger
      Copland of my staff met with several Agency  officials,
      including those from the Enforcement Division  and  the
      Office of General Counsel, to discuss the situation
      pertaining to products containing chlordane.

      Pursuant to that meeting,-I hereby  request that you"
      invoice the Special Rule of §15 (b) (2)  and-allow inven-
      tories of chiordane products formulated between July 29,.1975
      and December 24, 1975 and currently-on dealer  shelves to
      be sold until'such stocks are exhausted.
                                              •  .     *  *    * *
      There are several reasons for this  request:

           1) Recall is in most cases a practical  impossibility
              and constitutes an economic hardship,  particularly
              to smaller forraulators.   There are literally thou-
              sands of small retailers  who may have  a few units
              of chlordane products in  stock.  It  is not always
              possible for the formulator to ascertain where
              such products are being sold.   If stocks are dis-
              covered, compliance with" Department of Transpor-
              tation regulations governing the shipment  of
              hazardous materials becomes  a major problem,
              especially in view of the fact that substantial
              numbers of retailers will have only a  few  units
      ,    '   of various brands.
      •  •  m
           2)  Invocation of the  Special Rule will not create a
              health hazard.   Use of the products as directed
              may be the safest  way of  disposing of  remaining
              stocks.   The remaining supply  of chlordnne pro-
        i     ducts does not,  in relative  terms, constitute a
              large amount.   We  estimate that between 1,800,000

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                      -2-
   to. 3,600,000 units re.-n^in on the shc.lves of some
   75,000 retail dealers.  While the recall or stop-
   sale of these units would have an adverse economic
 '  impact on many formulators, their normal, generally
   outdoor use would not significantly exacerbate a
   situation that has been ongoing for some 26 years.
   Furthermore, we have heard that some dealers are/'
 .  simply flushing unmarketable units away, thereby
   pocsibly 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^e been"invoked.  By
   letter dated September 23, 19.75, the Office of
   General Counsel indicated that the sale of pro-
   ducts formulated after July 29th was legal until
   final suspension decision was made.  On December 24,
   you suspended most registrations and stated that.
   products formulated after July 29th could not be
   sold.   On March 23, 1976 the Enforcement Division
   requested formulators to undertake a voluntary
   recall of products formulated after July 29th.
   The net effect of these actions has been to en-
   gender confusion-in many people over the mandatory
   nature of a ban on sales.  While perhaps not de-
   cisive, we believe this factor should in good faith
   be considered.           ,.-      .                •
                          '                        *
4)  Harassment of dealers by some Enforcement officials,
   especially in the Northeast,  has fostered resent-
   ment of the Agency as a- whole and,  in some cases,
   strained relations along the distribution chain.
   The orderly sale of remaining inventories would-. • . .
   reverse these counterproductive tensions.         :


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                           -3-
Of course, should you  invoke  the  Special  Rule,  it would
alleviate indemnification problems  that will arj.so with
.respect  to products  formulated  prior to the Suspension
Order.          .                  .      •

I look forward to hearing from  you  concerning this impor-«
tant matter.•                         .
Ralph/Cngel
Executive Director
RErkas
cc:  A.E. Conroy

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 o*v
USB,
    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                WASHINGTON, D.C. 20460
                             APR  I 3
                                                 OFFICE 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
                                                 ides
      On February 23, 1987, in the case of the National Coalition
 Against the Misuse of Pesticides vs. EPA, the U.S. District Court
 ruled  that  the Agency's allowance of the continued sale and use
 of all cancelled chlordane and heptachlor products was void,
 and  ordered EPA to take "whatever action is necessary ... so
 that on and after April 15, 1988, sales, commercial use, and
 commercial  application of existing stocks of chlordane and
 heptachlor  which have been the subject of voluntary cancellation
 shall  cease..."  Since sale, distribution, and use of Velsicol's
 chlordane and heptachlor products are already prohibited after
 April  15, 1988, the District Court Decision effectively only
 applies to  the non-Vels1col chlordane and heptachlor products
 which  have  been voluntarily cancelled.
      In
order to
     ii i
Implement that Court Decision
                                                on April  5,  1988,
EPA issued a "Chlordane/Heptachlor Termlticides;  Notification
of Cancellation and Amendment of Existing Stocks  Determination."
That Notice Informed the public that the  registrations of the
products listed 1n that Notice are cancelled (see Appendix C for
this 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."Chiordane/
Heptachlor Termiticides; Notice of Intent to Suspend Registrations
and to Place Limitations on Sale and Use of Existing Stocks".
All of the chlordane/heptachlor termiticides affected  by this
April  5, 1988 Suspension Notice were previously suspended and
issued Stop Sale, Use, or Removal  Orders (SSUROs)  for  failure
to respond to the FIFRA §3(c)(2)(B) Data Call-in.   However, the
limitations on  sale and distribution of the previous suspension
and SSUROs only affected the registrants.  The recent  April 5,
1988  Suspension Notice includes prohibitions on the sale,
distribution, and use of existing  stocks of the suspended products
which are similar to  those imposed by the U.S. District Court
Order and the resulting Notification of Cancellation described
above.  That is, after the April  5, 1988 Notice of Intent to
Suspend becomes final and effective, no person may distribute,
sell, offer for sale, hold for 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 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 :;ays  after the date of publication in     ,
the Federal Register, or vf'ter completion of the suspension
heari ngs, whi che ver i s later.   OCM will inform the Regions when
the April 5, 1988 chlordane/heptachlor suspension  notice becomes
effective.

     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  app  nations
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.  Effectively,  this means that the only
non-Velsicol chlordane and heptachlor termiticides that may be
used  after April 14,  1988 are  homeowner products used  on  property
owned  and occupied by the individual user.

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                               -3-


     The  attached Revised Compliance Monitoring Strategy for the
Cancellation and Suspension of Chiordane/Heptachlor Termiticides
is  identical to the January 29, 1988 strategy in regard to the
Velsicol  products.  However, this revised strategy calls for
inspections of producing establishments, distributors/dealers/
retailers, and commercial users to assure that non-Velsicol
chlordane and heptachlor termiticides (i.e., both suspended  and
cancelled) are not sold, distributed, or used in violation of
the April 5, 1988 Cancellation Notice and Suspension Order.
Inspections of distributors, dealers, retailers, and commercial
users to  assure compliance with the chlordane/heptachlor suspension
and cancellation will  be conducted by States with Cooperative
Enforcement Agreements, and by EPA 1n States without Cooperative
Enforcement Agreements, as part of their routine inspections.

     The  attached revised strategy also calls for a books and
records inspection of registrants of the suspended chlordane and
heptachlor termiticides to determine the first-line distributors
of those  products.  The books and records inspection are to  be
conducted by States, or Regions in States without Cooperative
Enforcement Agreements, within 60 days of the date of this strategy.
States conducting the books and records Inspections are to transmit
information on the first-line distributors to the Regions where
Stop Sale, Use, or Removal Orders (SSUROs) are to be issued  to
those persons.  Regions are to transmit information on  first-line
distributors located in other Regions to those Regions.  Additionally,
States and Regions are to Issue SSUROs to distributors, dealers,
retailers, and users of suspended chlordane/heptachlor products
as it is  found during the course of routine inspections.  Please
note, registrants of the suspended products have already received
SSUROs in response to the previous FIFRA §3(c)(2)(B) suspension
action.  Therefore, sale and distribution of these products  by
the registrant would be a violation of FIFRA §12(a) (2) (I).  Sale,
distribution, commercial use and commercial application of cancelled
chlordane and heptachlor termiticides is a violation of FIFRA
§12(a)(2)(K).

    The attached revised strategy is effective Immediately and
replaces the January 29, 1988 strategy.  Please transmit a copy
of this strategy to the States within your Region immediately.
If you have any questions regarding the revised strategy, please
contact Dan Helfgott of my staff at FTS 382-7825.


Attachments

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                                 ADDRESSEES
II
III
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
IV    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
4-jgust 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 termltlcldes 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 1f air monitoring tests
reveal zero exposure from each use,  anT~provi ded certain  uses,
such  as use Inside the home and high pressure  injection,  remain
deleted from the label ("deleted uses",  see Appendix A for deleted
and retained uses).  Regions and States  will  be notified  if and
when  Velsicol has met the terms of the  conditional  registration,
and therefore, when Velslcol may resume  Its sale  of  chlordane
and heptachlor products.

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                               -2-


     On October 1, 1987, Velsicol  agreed  to  voluntarily cancel
its chl ordane/heptachl or termiticide  products  which  were not
conditionally registered pursuant  to  the  MOU.   The October 1, 198
Cancellation Order was  published in the Federal  Regi ster on
November 3, 1987 {52 FR 42145).   Under  the Cancellation Order,
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 chlordane/heptachlor termiticides by persons
other  than Velsicol.  Between December  1, 1987 and April 15,  1988,
stocks of Velsicol's chlordane/heptachlor termiticides  may be
sold,  distributed, and  used by  persons  other than Velsicol as a
Restricted Use Pesticide (RUP),  and only  in  accordance  with
the use directions found in the  Cancellation Order.   No  sale,
distribution, or use is to be permitted after April  15,  1988.

     On April 5, 1988,  EPA issued  a "Chlordane/Heptachlor
Termiticides; Notification of Cancellation and Amendment of
Existing Stocks Determination".   That notice informed the  public
that, after April  14, 1988, no  person may distribute, sell,  offer
for sale, hold for sale, deliver for shipment, receive  (and  having
so received) deliver or offer to deliver  to  any person,  or to
make commercial use or  commercial  application any non-Velslcol
chlordane or heptachlor product  which has been cancelled  (see
Appendix C for a list of these products).

     Also on April 5, 1988, EPA  issued  a  "Chlordane/Heptachlor
Termiticides; Notice of Intent to Suspend Registrations and  to
Place Limitations  on Sale and Use  of Existing Stocks".   All  of
the chlordane/heptachlor termiticides affected by that Notice were
previously suspended and issued  Stop Sale,  Use, or Removal Orders
(SSUROs) for failure to respond  to the FIFRA section 3(c)(2)(B)
Data Call-In.  However, the limitations on  sale and  distribution
of the previous suspension and SSUROs only  affected  the registrants.
The April 5, 1988  Suspension Notice includes prohibitions  on the
sale, distribution, and use of existing stocks of the suspended
products which are similar to those Imposed  by the U.S. District
Court Order and resulting Notification of Cancellation described
above.  That 1s, after  the April 5, 1988  Suspension  Notice becomes
final and effective, no person may distribute, sell, offer for
sale, hold for sale, deliver for shipment,  receive (and having
so received) deliver or offer to deliver  to any person, or to
make commercial use or  commercial  application of suspended chlordane
or heptachlor products   (see Appendix D).

     Please note that while the  original  Suspension Orders which
affected only registrants remains in effect, all persons adversely
affected by the April 5, 1988 suspension  notice may  request  a
hearing within 30  days   of publication of  that notice.  The existing
stocks provisions  of the April  5, 1988 Suspension Notice which
affect persons other than registrants will only take affect  30
days after the date of  publication in the Federal Register,  or
after completion of the suspension hearings,  whichever is later.
OCM will inform the Regions when the April  5,  1988 chlordane/
heptachlor Suspension Notice becomes effective.

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                               -3-
 REGULATED  INDUSTRY
     The sole producer of technical  chlordane and heptachlor  in  the
 United States is Velsicol Chemical Corporation.   The October  1,  1987
 cancellation order affects registrants [i.e., Velsicol  and  its
 supplemental registrants (see FIFRA Compliance Program Policy'
 No. 3.9)], distributors/dealers/retailers, and users of Velsicol 's
 chlordane/heptachlor.  The October 1, 1987 cancellation order
 does not affect non-Velsicol  chlordane and heptachlor termiticides.

     The April  5, 1988 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
 Cal1-In (see Appendix D).

     Please note that for purposes of the April  5, 1988 chlordane
 and heptachlor suspension and cancellation notices, the prohibition
 on sale, commercial use and commercial application applies to
 sales of chlordane and heptachlor termiticides in any situation,
 and to all use and application of such products with the exception
 of use and application in accordance with label  directions by
 individuals (as opposed to organizations, government agencies,
 corporations, etc.) on property owned by those individuals.
 However, this exception for individuals  shall not apply to use
 or application  by individuals on property which is owned by them
 but which is rented or leased to others  and is occupied or intended
 to be occupied  by human beings, nor will it apply to new structures
 under construction for sale or lease.  In short,  this means  that
 the only non-Velsicol chlordane and heptachlor termiticides  that
may be used after April 14, 1988, are homeowner products used on
 property owned  and occupied by the individual user.
            >

REQUIREMENTS OF THE AUGUST 11, 1987 MEMORANDUM OF UNDERSTANDING

     As per the August 11, 1987 MOU, Velsicol may not  sell or
 distribute any  of its chlordane/heptachlor termiticides after
August 11, 1987.  Products that remain conditionally  registered
may only be sold and distributed by Velsicol  when the  terms  of
 the conditional  registration are met (OCM will Inform  the Regions
when  this occurs).  Other persons (i.e., distributors/dealers/
 retailers,  users, and non-Vels1col registrants) were  not affected
by this agreement.

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    ! !H
Register /  Voi  52  N'o. 2"2  '  Tufsdny. N'ovc-i'pr 3. 196"  /  Notices
    ;;  ..  '  -.^ si j!l bi-n«iilo with
    •• ••• .ri j ,!••••, !t..i:; 50 p s i  d! the
    • .•/.'• .I*.-; .1 coj'Sf- spray nozzle
    • •' •;. r-vur.-iisS-.n;: hor;7onta! bcirrn?:s
    i.'.r.r.rr•'.<• sijos cannot be poured
    ••i: i.j.i UK- virr.c day it has been
    i.-uii-ii .1 v\j!rr-proof cover, such as
    olyethylene shec;:r.g. should bu
    ijccd o-.cr the soil to prevent
    r&$;cr.. Th:s is not necessary' if
    .urd.itiun walls have been msi.illcd
    round  the treated soil.
Vrr'.K.iii Barriers
  Afvr the fourri,it;on walls have been
pouroJ cr buiit but before slabs are
poured, vertical barriers may be
est  il.'l.shrd ir. soil which will be under
the perimeters of  floating or supported
slj.is. around utilities which w;ll
pp"t!r.i:«!  the slab and in other critical
;ii':;is which will be covered by
r;:n; r-.-io. After the final exterior grading
is i  -rrpletcd. vertical barriers may be
crcaifd in bflck-fil!°d soil against
foundation walls or against the outside
of rncnohth:c slab. To produce a vertical
darner, apply ihe emulsion at the ra'.e of
4 c.'llrns per linear fret per foot of depth
from cr.TtJi: tn ihe  top of the footir-. For
r<--:-..-!i!htr. shhs  apply to :he bottom of
Ihi1  uirjrflr.
— I  .A\ rrrssurr rrJdinc and/or
  ;•• r ••:::::» .ir plications  she'jld nc'. be
  -.  :.  bflow the :op of the fcciinj
  txcpp1. whrn the footing is expos?d  j;
  or dlcvr grade. Spend care should
  b^ tdkcn to avoid soil washout around
— When redding, use only low pressure
  (less thar. 25 p.s.i. at the nozzle). I; is
  important that emulsion reaches the
  focti-g. Rod holes should be spaced to
  prcvsde a continuous barrier.
—Trenches need not be wider than 6
  inches.
—Emulsion should be mixed with the
  soil as  it is being replaced in the
  trench. Cover treated soil with
  approximately 2 inches of untreated
  soil.

C.~cw! Space Foundations
  For crawl space foundation* vertical
barriers may be established in the soil
on the outside perimeter of the
foundation using a rate of 4 gallons of
emulsion per 10 linear feet per foot of
depth from grade to the top of the
footing. Application may  be made by
low pressure rodding and/or trenching
to the footing. If the footing is exposed
at or above grade, application should be
nude with special care to avoid wash-
out around the footing
— Do not treat the footing through
  hollow masonry voids.
             — Rod h.iii:» srv.uld I'- 
               inches  nor below thr f^ot.np Thn
               emulsion should be mixed w;ih thr
               soil as  it is being replaced in the
               trench. Cover the treated  soil with
               approximjteiy 2 inches of untreated
               soil.
             —A complete termite barrier may
               require treatment with another EPA-
               registered product to the inside
               perimeter of the foundations and to
               other interior  critical areas.

             Basement Foundations

             Horizontal Barriers
               After exterior grading is completed
             and prior to the  pouring of concrete
             slabs. hor:zoru! barriers may be
             established or. soil which will be
             covered by concrete entrance platforms.
             and in other exterior critical areas
             which w:li be covered by concrete slabs.
             To produce a /.onzontal barrier, apply
             the ermlston at  the rate of 1 gallrr. per
             10 square feet to fill dirt. If fill is washed
             pravul or otiicr coarse material, apply at
             1'/: gallons per 10 square fee'..
             —It 15 IJT-T rtant that the emjision
               reHch.es '.he so:i
             —Applications shj!! be made (with
               pressures less than 50 p.s.i. £'. the
               nozzle) us;ri£  a course spray nozzle
               when establishing horizontal barriers.
             —If concrete slabs cannot be poured
               over soil the same day it has been
               treated, a water-proof cover, such as
               polyethylene sheeting, should be
               placed over the soil to prevent
               erosion.
             —Do not apply to any area  inside the
               foundation wall.

             Vertical Barriers
               After the final exterior grading is
             completed, vertical barriers may be
             created in back-filled soil against
             foundation walls. To produce a vertical
             barrier, apply the emulsion by low-
             pressure  rodding or trenching at the rate
             of 4 gallons per linear feet per foot of
             depth from grade to the top of the
             footing.
             —Low pressure rodding and/or
               trenching applications should not be
               made below the top of the footing
               except when the footing is exposed at
               or above grade. Special care should
               be taken to avoid soil washout around
               the footing.
             —When  rodding. use low pressure (less
               Ihnn 25 p.s.i at the nozzle), it is
               important thtfi emulson roaches the
               footing. Rod holes should be sp;i(,p.tl to
               provide a continuous
— Trenches need not be w.Jcr thjr. C
  inches.
— Emulsion should bo m:\cd w:th '.!•.<'
  soil as it is facing replaced in ttv
  tr^nr.h. Cover irejit-d sell with
  approx;nidtely 2 inches of untreaird
  soil.
Pcs!co:is:rjc:ion

Dilution Instruction fcr Gold Crest
Termide

  Use a .75"* water emulsion for
subterranean termites other than
Coptoier.T.cs spp. Mix 1 gallon of Gold
Crest Tcrmide in 99 gallons of water to
produce at 075ri water emulsion. Uie a
0.75-1.5% wdter emulsion for
Coptoterrr.es spp. where necessary. Mix
1-2 gallons of Gold Crest Terrmde in 90
gallons of water to produce a 0.75-1.5%
water emulsion.

Dilution Instructions for Gold Crest ClOO
and Chlordane 8EC/Termite

  Use a 1% water emulsion for
subterranean termites other than
Copto'.ermes spp. Mix 1 gallon of
product in 95 gallons of water to
produce a 1% water emulsion. Use  a 1-
2^ water emulsion  for Coptote.-mes spp.
where necessary. Mix 1-2 gallons of
product in 95 gallons to produce a 1-2^
emulsion.

Dilution Instruction for Gold C.-est  H-60

  Use a .5"« water emulsion for
subterranean termites  other than
Crptotermes spp. Mix  1 gallon of
product in 59 gallons of water to
prodcuc a .5% water emulsion. Use a 1%
water emulsion for Coptoterir.es spp.
where necessary'- Mix  2 gallons of
product in 59 gallons of water to
produce a 1% water emulsion

Dilution Instruction for Gold Crest C-50

  Use a 1% water emulsion for
subterranean termites other than
Coptotermes spp. Mix 1 gallon of
product in 47 gallons of water to
produce a 1% water emulsion. Use a  2%
water emulsion for Coptotermes spp.
where necessary. Mix 2 gallons of
product in 47 gallons of water to
produce a 2% water emulsion.
   Do not apply this produce into hollow
masonry voids.
   Do not apply this product to soil
beneath the interior of the structure. Do
not apply to the soil beneath a plenum
air space.
   Do not apply emulsion until location
of pipes, water and sewer lines and
 electrical conduits arc known und
 identified.
\
5

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                                      Vnl
                                                                                                              42I4H
S.::' C ":<:!: (jrlmr
 • V . r'i  ,,; h.iriir.-b m.v. !«• i-si,, ',.',, In J
.li'iii^ in-' u>.t.,i(if of Ihc fniiii.jjlion bv
I in pri-s ..;:•• mddmg and/or irrnchm;
,ii the rjh- of 4 R.iilons of emulsion per
in iim-.ir frrt Low  pressjic roddiny
•..••nulJ no! extend beyond '.lie lups of
i:;r  fn.i'ir.cs
— When jodding. use only low pressure
  (Irss ;han 25 p s.i. at the no:zie).
— ijr;!l holes in ou!s:de slabs (palios.
  side\\a!ks. etc ! nhout 12 to 30 inchoi
  up.i.'t  io pro'.ice  a continuous
  rhcnrr, .1! bnmer.
— ! or sr.iiiow founiiatior.s. 1 foot or
  less. d;£ a narrow treich
  ;:pprcx;mate!y six inr.hes wide along
  the cutsidc of  the foundation walls.
  Do ret t.'ench  below the bottom of the
  foundation The  emulsior. should be
  iipp'ied Iti the  trench and tlie soil at 4
  ^aliens per TO  linear feet as the  soil is
  replaced m the trench. Cover the
  lrc;i'-d soil with approximately 2
  inches of untreated soil.
— For foundations  deeper than 1 foot
  npply 4 gallons per 10 linear feet per
  foot of depth.
  For basement foundations, outside
perimeter barriers may be applied only
by trcT.chir.c or the excavation
tc-hn:que below ct a rn!e of 4 gallons of
rrr.u'sion per 10 linear feet per foot of
depth to he treated. Where exterior
sijlis arc adjacent to the foundation
wall, drill through the slab along the
outside of the wall at a spacing '.hat
provides application of a continuous
b.irrcr and apply the emulsion just
under the slab.  After drilling, emulsion
may be applied. Apply only at the
lowest pressure that will start  the floxv
of emulsion from an unobstructed rod.
Apply up to 4 gallons of emulsion per 10
linear feet.
  A complete termite barrier may
require application of another  EPA-
registered product under interior slabs.
through hollow masonry voids to the
footing, and to other interior critical
areas.
E\covation Technique
  If treatment i* to be made in difficult
situations such at near wdl* or cisterns.
along faulty foundation  walls,  and
around pipes and utility lines which lead
downward from the structure.
application must be made in the
following manner to avoid intrusion of
termiticidc into water supplies or the
interior of the structure.
— Trench and remove the scil to be
  treated only heavy plastic sheeting or
  similar liner.
—Treat the soil at the rate of 4 gallons
  of emulsion per 10 linear feet per foot
  r.f ilc;i;h nf ld«- 'rrrT-h. M;v the
  C'iMiUi.in MorT.ichly i"'" 'lie *•"•!
  l.if..:1!. i. .ut1 i.  ; 'i vi/ni li^uij fi,>in
  run::. iv uff t.' •• hr.i r.
— Aficr the Jre.r.ed s.i:i hjs lirn. d
  .•idcvjii.ile'v. ri-fldfr t!.e .ml .n il.p
  trench and cover wi:h .•ipi'roxi-i..iely
  2 inches of untreated soil.
         n: Ri.-ftrit.tions
  Rplreatmcnt for subterranean termites
should only be made when there is
evidence of reinfcstation subsequent to
the initial treatment, or there has been
disruption of the chemical barrier in the
soil due to construction, excavation.
l;ir.dscaping. etc. Retreatment shojld be
made as a spot appiicHlion tc these
areas.
  Re'.rentmcnt? may be made to critical
ureas in accordance w-ith 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 bz obtained from the
person listed under FOR MORE
INFORMATION CONTACT:
  Daitfd: Ocli:bcr23. lacr.
Douglas D. Carr.pl.
Director. Oef,cg of P "SUciJe Prvgrcm:.
|FR Doc. 87-25383 Filed 11-2-67. e.J5 am;
BILUHO COM
| OPP- 180747; FRL-3286-5)

California Department of Food and
Agriculture; Receipt of Application for
Emergency Exemption To Use
Hydrogen Cyanamlde; Solicitation of
Public Comment
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice.

SUMMARY: EPA has received a request
for an emergency exemption from the
California Department of Food and
Agriculture (hereafter referred to as the
"Applicant") to use the active ingredient
hydrogen cyanamide ("Dormex") to
promote uniform bud break in 18.600
acres of table grapes grown in the
Coachella Valley in Riverside County.
California. Dormex contains an
unregistered active ingredient and.
therefore, in acordance with 40 CFR
166.24. EPA is soliciting comment before
making the decision whether or not to
grant the exemption.
DATE: Comments must be received on or
before November 10. 1987.
ADDRESSES: Three copies of written
comments, bearing the identification
ni'i.i1:.,:  OIT.i.iir.j-." v|. • .;

S.-r\;> , s S. ,.!.,.•; I'rir ... M

(if IVslu	• Pmri jn:>  K..I >:.•


  In pei son. bn:ig comrr.ei'.U U. R:n  2.io.
Cr\st.il MJ|! =2. 1921 Jefferson U.IMS
Highway. Arlington. VA.
  Inform.ilion submitted in nr.y
common! concerning tins notice .i'..iy l>e '
rluimed confidential by  marking jny
part or all of that information ns
"Confidential  Business Information
(CBI)." Information so marked wiii not
be disclosed except in -iccordjnce with
procedures set forth in 40 CFR Part 2. A
copy of the comment th.it docs contain
C13I must be submitted far incl-sior. :r.
the public record. Information not
marked confidential may be disclosed
publicly by EPA without prior nctico tt;
the submitter. All written comments will
be available for inspection in Rm. 230 at
the address given above from 8 a.m. to 4
p.m.. Monday through Friday, excluding
legal holidays.
FOR FURTHER  INFORMATION CONTACT:
By mail. Libuy Pemberton. Rig:stralior.
Division (TS-767C). Office of Pesticide
Programs. Environmental Protccticr.
Agency. 401 M Street. SVV.. \Vash:np:o.-..
DC 20460.
   Office location and telephone number
Rm. 716. Crystal Mall =2. 192:
Davis Highway. Arlington. VA.
557-1800).
SUPPLEMENTARY INFORMATION: Pur.uar.t
 to section 18 of the Federal Insec.tic.Je.
Fungicide, and Roden!:cide Act (F1FRA)
{7 U.S.C. 136p). the Administrator may,
at his discretion, exempt a State agency
 from any provisions of FIFRA if he
determines that emergency conditions
 exist which require such exemption.
   The Applicant has requested the
 Administrator to issue a specific
 exemption to permit the use of an
 unregistered plant regulator, hydrogen
 cyanamide (CAS 420-04-2).
 manufactured as Dormex. by SK'A'
 Trostberg Aktiengesellschaft. tc promote
 uniform bud-break in table grapes
 grown in the  Coachella Valley in
 Riverside County. California.
 Information in accordance with 40 CFR
 Part 166 was  submitted as part of this
 request.
   Approximately 18.800 acres of table
 grupes.  Vitis  spp.. are grown in the
 Coachella Valley. The Applicant
 indicates that California growers rf  ;
 early market  table grapes are f.'icir.g
 economic losses due to increasing
 competition from  foreipr. irr.pcrts.
 particularly from Mcx'co. The Apj^-^r'.:

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                              -4-


 REQUIREMENTS OF THE OCTOBER 1. 1987 CANCELLATION ORDER

      The  registrations of Gold Crest Termide, Gold  Crest  C100,
 and  Chlordane SEC Termite were amended by splitting each  registration
 into  two  separate registrations.   A new EPA registration  number
 was  assigned for each of the above End Use products for the  uses
 described in Appendix A as "retained uses".  The remaining  uses
 for  each  of the above products maintained their current EPA
 registration numbers of 876-233,  876-63, and 876-104 respectively.

      The  registrations of .Gold Crest Termide, Gold  Crest  C100,
 and  Chlordane SEC Termite, which  have maintained their  current
 EPA  registration numbers of 876-233, 876-63, and 876-104  have
 been  voluntarily cancelled effective September 30,  1987 along
 with  the  following Velsicol products: Gold Crest C-50 (876-86),
 Gold  Crest H-60 (876-S5), California SLN for crawlspace perimeter
 spray  (Termide) (CA-810012), California SLN for crawlspace
 perimeter spray (C-100) (CA-810012), and Hawaii SLN for crawl-
 space  perimeter spray (C-100) (HI-850003).  The cancellation
 order  also affects Velsicol's supplementally distributed  products
 (the  list of supplemental registrations are in Appendix B).

      The  Gold Crest Termide, Gold Crest C100, and Chlordane
 SEC  Termite products which bear the "retained uses" and have
 been  assigned new EPA registration numbers are not  cancelled.
 These  products continue to be conditionally registered  with
 EPA  but may not be sold and distributed by Velsicol until the
 terms  of  the conditional  registration, as outlined  in the
 August 11, 1987 MOD, are met.  Additionally, the cancellation
 does  not  affect the following Velsicol Chlordane and heptachlor
 products:  Technical Chlordane/ Export (876-280); Technical
 Heptachlor/Export (876-288); and  Technical Heptachlor/Formulation
 of Fire Ant Granular for Cable Closure Only (876-330).   Please
 note, as  per the MOU, except for the Technical Heptachlor/Formulation
 of Fire Ant Granular for Cable Closure, none of the above products
may be sold or distributed by Velsicol in the United States even
though they have not been cancelled.

 Existing  Stocks for Velsicol's Chiordane/Heptachl or Termiticides

     As per the October 1, 1987 cancellation order, persons
other than Velsicol [and its supplemental  registrants(see 40 CFR
 162.6(b)i(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.

-------
                               -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 S12(a)(2) (F).

 REQUIREMENTS OF THE APRIL 5. 1988 NOTIFICATION OF CANCELLATION

     The April  5, 1988 Notice of Cancellation announces the
 cancellation of the chlordane and heptachlor products listed
 in Appendix C,  and establishes limitations on the sale and  use
 of existing stocks of these products.  Please note, the products
 affected by this notice were previously voluntarily cancelled at
 the  request of the registrant.

 Existing Stocks	

     It is unlawful for any person to distribute, sell, offer
 for  sale, hold for sale, deliver for shipment, or receive (and
 having so received) deliver or offer to deliver to any person,
 or to  make commercial use or commercial application, cancelled
 chlordane and heptachlor termiticides after April 14, 1988.

 REQUIREMENTS OF THE APRIL 5. 1988 NOTICE OF INTENT TO SUSPEND   ~

     The April  5, 1988 Notice of Intent to Suspend will suspend
 the products listed 1n Appendix D of this strategy for continued
 failure to submit data within the time periods required by  the
chlordane and heptachlor Data Call-in, as contained in the  December
31, 1986 Chlordane and Heptachlor Registration Standards.  All
products affected by this Notice have previously been suspended
for failure to  commit to comply with the terms of that Data Call-in.
However, the previous chlordane/heptachlor suspensions did  not
place  prohibitions of the sale or use of existing stocks of
suspended products by persons other than the registrant.  Any
suspensions resulting from the April 5, 1988 Notice of  Intent to
Suspend will Include prohibitions on the sale and use of existing
stocks of suspended chlordane and heptachlor termiticides.

-------
                               -6-
Existing Stocks
     When the April 5, 1988 Notice of  Intent  to  Suspend  becomes
final and effective for a particular  product  listed  in Appendix D
(either 30 days after publication in  the Federal  Register  or
upon completion of a suspension hearing) no  person may distribute,
sell, offer for sale, hold for sale,  deliver  for shipment,  or
receive (and having so received) deliver or  offer to deliver to
any person, or to make commercial use  or commercial  application,
suspended chlordane and heptachlor termiticides.

COMPLIANCE MONITORING

     Conformance with the August 11,  1987 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 is a violation  of FIFRA sections  12(a)(l)(A)
and 12(a)(2)(K).

     The Agency, and States with authority,  are to issue Stop  Sale,
Use, or Removal Orders (SSURO) to any  person  who distributes,  sells,
offers for sale, holds for sale, ships, delivers for shipment, or
receives and (having so received) delivers or offers to  deliver
chlordane and heptachlor termiticides  other than in  accordance
with the October 1, 1987 Cancellation  Order  and the  April  5,  1988
Notice of Cancellation and Notice of  Intent to Suspend.

Neutral  Administrative Inspection Scheme (NAIS)	

     Except for the initial inspections of Velsicol's establish-
ments, all Inspections for violations  of the October 1,  1987
Cancellation Order will take place as part of the Regions' and
States'  routine Inspections.  Inspections of Velsicol's  producing
establisments to assure conformance with the MOU and compliance
with the October 1, 1988 Cancellation Order are to take  place by
April  29, 1988.

-------
                               -7-
      Inspections of distributors/dealers/retailers,  and commercial
 users  to assure compliance with the April  5, 1988 Notice of  Intent
 to  Suspend will also  take place as part of the Regions and States
 routine inspections.  However, within  60 days of the date of
 this  strategy, States, or Regions in States without Cooperative
 Enforcement Agreements, are to also conduct a books and records
 inspection of registrants of the suspended chlordane and heptachlor
 termiticides to determine the first-line distributors of those
 products.  States conducting the books and records inspections  are
 to  transmit information regarding the  first-line distributors  to
 the Regions.  Upon receipt of this information,  Regions are  to
 issue  SSUROs to those persons identified as first-line distributors
 in  their Region.  Regions are to transmit information on first-line
 distributors located  in other Regions  to those Regions, where  the
 SSUROs are to be issued.  Additionally, States and Regions are  to
 issue  SSUROs to distributors, dealers, retailers, and commercial
 users  of suspended chlordane/heptachlor products as they are
 found  during the course of routine inspections.   Compliance  with
 the SSUROs will be monitored in accordance with the Pesticides
 Inspector1s Manual.

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

     Please note, registrants of the suspended products have already
 received SSURO's in response to the previous FIFRA §3(c)(2)(B)
 suspension action.   Therefore, sale and distribution of these
 products by the registrant would be a  violation of FIFRA §12(a)(2)(I)
 Sale,  distribution, commercial use and commercial application  of
 cancelled chlordane and heptachlor termiticides is a violation
 of FIFRA §12(a)(2)(K).

 Registrant/Producer Level	

     By April  29, 1988, the Agency/States will schedule and
conduct inspections of Velsicol's establishments to obtain
assurance that Yelslcol 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
	 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
f c 11 n n -
will
have
i n v
SSUROs.

-------
                               -8-


Distributor/Dealer/Retail  Level

     After November 30, 1987,  when  conducting  routine  inspections
at the d1stributor/dealer/retail  level,  inspectors  will  check  to
determine whether Velsicol's chlordane and  heptachlor  termiticide
products are being sold and distributed  in  accordance  with  the
October 1, 1987 Cancellation Order.

     After April 15,  1988, when Agency/States  conduct  routine
inspections at the distributor/dealer/retail  level, they will
assure that remaining stocks of cancelled chlordane and  heptachlor
termitic ides are not  being sold.

     After the effective date of  the suspension order,  the  Agency/
States will conduct routine inspections  at  the distributor/dealer/
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  the
user level, Agency/States will  assure that any remaining  stocks
of Velsicol chlordane and heptachlor are not being  used,  and
remaining stocks of non-Velslcol cancelled chlordane and  heptachlor
products are not being used for purposes of commercial  use or
commercial application.

     After the effective date of the suspension order,  and during
routine inspections at the user level, the Agency/States  will
assure that remaining stocks of suspended chlordane and heptachlor
are not being used for commercial use or commercial application.
ALLOCATION OP RESPONSIBILITIES	

Office of Pesticide Programs	

0 Will develop and provide OCM with a 11st of those products
  which have been cancelled/suspended.

0 Will notify OCM when registrants of suspended chlordane and
  heptachlor products agree to voluntarily cancel their products.

0 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  S3(c)(2)(B).

0 Will transmit to the Regions the list of  those  products
  which have been cancelled pursuant  to the October  1,  1987
  Cancellation Order,  cancelled as specified in  the  April  5,
  1988 notification,  or suspended pursuant  to  the  April  5,
  1988 Notice of Intent to Suspend.

0 Will transmit a list of establishments  producing Velsicol's
  chlordane and heptachlor termiticides to  the Regions.

0 Will notify the Regions if and when Velsicol  has met the  terms
  of the conditional  registrations of Gold  Crest  Termite,  Gold
  Crest C100, and Chlordane SEC Termite,  and therefore when  these
  products may be sold and distributed.

0 Will notify Regions  of the effective date of the April  5,  1988
  Notice of Intent to  Suspend Chlordane and Heptachlor Termiticides

Regions	

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

8 Will distribute lists of products  to the  States.

0 Will  conduct distributor/dealer/retailer  and user inspections
  in States without Cooperative Enforcement Agreements as part
  of their routine 1nspect1onal program.

0 Will conduct a books and records inspection, in States without
  Cooperative Enforcement Agreements, of non-Velsicol  chlordane/
  heptachlor registrants to determine the first-line distributors
  of those products.

0 Will Issue SSUROs to first-line distributors,  of non-Yelsicol
  chlordane and heptachlor products,  located in their Region.

0 Will transmit Information on first-line distributors located
  in other Regions to  those Regions.

0 Will monitor SSUROs  as per the Pesticides Inspectors' Manual.

0 Will  take enforcement action, Including Issuing SSUROs, as
  appropriate.

-------
                              -10-
0 Will report to OCM quarterly for one  year  on  any  enforcement
  actions taken within their Region,  including  State  actions,
  under the cancellation  and suroension actions.  This  report
  should include any occurrence of non-conformance  with the
  terms of the MOU by Velsicol.  As stipulated  in the January  29,
  1988 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.

8 Will notify the States  of the effective date  of the chlordane/
  heptachlor suspension.

States	

0 Will conduct inspections by April 29, i988, of  Velsicol's
  establishments that produced chlordane and heptachlor within
  the past 2 years.

0 Will inspect for compliance during routine distributor/dealer/
  retailer and user inspections.
o
  Will conduct a books and records inspection of non-Velsicol
  chlordane/heptachlor registrants to determine the first-line
  distributors of those products.

0 Upon identification from the books and records inspections,
  States will transmit information on the identity of first-line
  distributors to the Regions.

0 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 stipultaed 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  Termiticides
                   00876-IL-001
          Velsicol  Chemical  Corporation
              Box  39A  II linois  HWY  1
                Marshal 1 ,  IL 62441
                   00876-TN-001
          Velsicol  Chemical  Corporation
               1199 Warford  Street
                Memphi s ,  TN  38108

-------
                      APPENDIX A

 (           Retained ana Deleted Uses of
 r       V e 1 s i c o 1 ' s Chlordane/Heptachlor Products
i
       Velsicol  classified  the  following uses of

       ics  end-use  termiticide  produces as

       "deleted  uses":

         a.    post-construction application of
              material  trom within a  structure
              frequented  by humans ("structure");

         b.    post-construction application of
              material  from outside a structure
              to inside or  underneath a structure;

         c.    the use of  pressure rodding for post-
              construction  application of material
              to a  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 of  voids and  spaces in
              masonry or  block  walls  or areas
              behind veneers;

         f.    applications  by non-certified
              applicators;

         g.    soil-injection pressure rodding at
              pressures greater than  25 psi.


            The  agreement further classified  the

       following uses of  end-use  temiticide

       products  as  "retained uses":

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

-------
                  -2-

               APPENDIX  A
  b.    applications by the excavation
       technique to the exterior  of  any
       structure (i.e.. by removing  soil
       next to the foundation,  placing
       on a carp,  treating with
       cerraiticide, and placing back in
       trench after soil dries);

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

  d.    post-construction low-pressure
       (maximum 25 psi) vertical  rodding
       (with the application rod  equipped
       with a pressure control  device  to
       prevent higher pressures)  outside
       slab and post and pier type
       structures;

  e.    pre-construction coarse  spray
       surface treatment (maximum 50 psi)
       and low-pressure (maximum 25  psi)
       vertical rodding (with the
       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, iater alia, the

rollowing provisions:

0  The retained uses were converted to
   restricted uses as provided  for in
   Sections 3(d) and 4 of F1FRA;

-------
            - J-

        A?3£NOIX A
The registrations of the retained
uses were amended to conditional
registrations, with no sale or
distribution by Velsicol allowed
until certain conditions set forth
in the Conditions of Registration
are met.

No further sale or distribution by
Velsicol of end-use products labeled
for deleted uses was allowed.

Velsicol amended the label of its
manufacturing-use products to provide
that such products could not be used to
manufacture any end-use product (other
than Velsicol products) for sale and
distribution in the United States that
is labeled for use as a subterranean
teraiticide.

-------
                           APPENDIX B

             Supplenental Registrants of Velsicol
               Chlordane/Heptachlor Termiticides
 ;d76-G3053-000192)

 376-00063-000430)
(376-
(376.
(876-
(876-
(376-
(376.
(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)
•00:387)
(876-00036-005887)

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

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

(376-00104-004876)
(876-00104-006723)
(376-00104-025030)
(376-00104-042761)
(876-00233-001927)
(876-00233-006754)
Drexol Chlordane 72. Termite Spray  for
Professional  Termite Use
Durham's Cnlordane Emu Isifiable 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 45% Termite  Spray (Prof./Termite Use
AG Chlordane 4-EC Termite  Control
Black Leaf 45J Chlordane Termite Killer
Black Leaf 45% Chlordane
Around Bui 1di ngs
Black Leaf 45% Chlordane
Insect icide
Red Wi ng Chiorda ne 4 EC
Ford ' s Chlordane 4 EC
K Mart 45% Chlordane Termite
K Mart 45% Chlordane Termite
Bu i1di ngs
Pro-Chlordane 4-E
Dexol Chlordane Termite Spray
Durham's Chlordane SEC Emulsifiable
Pee Gee 8 1 bs. per gallon  Chlordane
Concentrate
Chlordane-8 Termite Control
Red Wing Chlordane SEC
Red Panther Chlordane
Red Panther Chlordane SEC
Terminix C-H
Orkil 2X
Termite Killer For Use

Emulsifiable Consentrate
                                            Killer
                                            Killer
                                             for Use Around
                                                   Concent rat e
                                                   Emuls i fi a&le

-------
P»B« I:.      \
01/06/88
         s:;?  SALIS ISJ:ZD AS .-.
                                       of  Products  Containing
                                      rdane  and Heptachlor
                                        i si::::*
                                        :••  ?!FEA
COSPAST
WVA: CEEF.ICAL COEP.
4100 HAST  HAS-IH3TOI BLVD
LOS ANGELES    CA 90023

AHVAC C-a:CiL CC2?.
41CC EAST  BASEIH70S 5lVj
LOS HGELES    CA 90023

&KVAC CRHCAI COB?.
41CC EAST  W.S-1SCT08 BtA'D
LOS ASGELES    CA 9C023
IIC'J ERST  »AS-!S;*0)i r'.v?
LOS ABGELES    CA 90C23
A2 CHZC.IC.'.:  COE?.
1514 ELEViSTc  "
METSC.03TH     OH
AS CE-ITiCAL C"5?.
!5:4 ELEVESTr  ST
K-STS«:Tii    OE  456^2

AS C;!-::AL CO-P.
1514 ILEVEST:  S!
tC-STSKITB    OH  45cc2

B 4 G CC-BPM!
1C539 tJCitm  H BOX 20372
DALLAS        TX  75220

BLAC? LEA? PSOtTCTS CO.
66? I STATE ST
ELGI5         11  60128

BLACK LEA? PSODCCTS CO.
667 I STATE ST
              IL  60120
BOSDIB CHSKiCAl CO., HC.
2 mi AVE.
TOEJVILLE     NY  13495
  Ht'IE CHZSICAL  CO., ISC.
2 HI;RZ AVE.
KOS«VILIE     SK  13495

EOHDIJ CSEC.ICAL  CO., ISC.
i «:3I AV:.
TOsfViLLE     NK
                              ??*:::-.!   F£J:I;:T k CEHICAI
                             546!  223
                             548^  226
                             5481  315
                              546!   50
                             7122  12!
                              7122  3
                              ?;::
                              86:2  66
                              5i6?   127
                               ««?  6';
                              4      274
                              4      2?5
                                         CHLCSDASE
                                         CELORDASE
                                         CHLOBDA8E
                                         C£LO?.:'A*i:
                                         CHW3DAS!
                                         CHLOF.DMS
                                         CHLORDA8E
                                         CslOSDASE
                                         CHLOSLANE
ss iss:-:  LI?::A:E ?•;::!<  ?:••


01/06/66     /  /   OS     CA



01/06/88     /   .'   09     CA



01/06/88     /   /   09     CA



01/06/88     /   /   09     CA



01/06/88     /   /   05     OR



01/06/58     /   /  ' 05     OE



Ol/Ob/68     '   /   05     0:



01/06/88     /   /   G6     !X



01/06/88    /   /    05     :L



01/06/88    /   /    C5     IL



01/06/88    /   /    ;2     V.



31/06/83    /   '    <.i     Si
                                                                                      U1/06/S8
                   U     S:

-------
                           APPENDIX B

             Supplemental  Registrants of Velsicol's
               Chlordane/Heptachlor Termi tic ides
(876-00063-000192)

(876-00063-000430)
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
00063
00063
00063
00063
00063
00063
00085
00086
00086
00086
00086
00086
-002935)
-005887)
-010370)
-025030)
-034704)
-043227)
•035034)
-000016)
-000192)
-004876
•005887)
-005887)
(876-00086-005887)

(876-00086-006723)
(876-00086-010370)
(876-00086-012000)
(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% Chiordane
Around Buildings
Black Leaf 45% Chiordane
Insecti ci de
Red Wi ng Chi ordane 4 EC
Ford's Chiordane 4 EC
K Mart 45% Chlordane Termite Killer
K Mart 45% Chlordane Termite Killer
Bui 1di ngs
Pro-Chlordane 4-E
Dexol Chlordane Termite Spray
Durham's Chlordane 8E3 Emulsifiable Concentrate
Pee Gee 8  Ibs. per gallon Chlordane Emulsifiable
Concentrate
Chlordane-8 Termite Control
Red Wing Chlordane SEC
Red Panther Chiordane
Red Panther Chlordane SEC
Termi nix C-H
Orkil 2X
Termite Killer For Use

Emulsifiable Consentrate
                                                   for Use Around

-------
 COMPAI7Y

 Bonide Chemical
Dragon  Cneiuical
Corporation
Rigo Company
Incorporated

Thompson-Hayward
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
EFFECTIVE r

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
                              4/27/8'
                                                  6/01/87

-------
                        -a-
       Industries
Tobacco States Chemical
Company


Chevron Chemical
Company


FI-iC Corporation
143-139

1911-42
192-43
192-132
192-133
226-177
226-184
239-478
239-1232

279-383
279-538
C.J. I-'artin Company      299-171

Residex Corporation    . 373-26
3/ 30. Sc
3/20/85
3 / 3 0 / 8 S
3/30/88
4/27/87
4/27/67
3/25/87
3/25/87

3/07/87
11/01/86

3/25/87

3/25/87
 Imperial  Incorporated
Boy1e-Mi dvay  Inc.

Rocklar.a Chemical
Company Incorporated

Haviland 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'
Mr A Oil Coir.par.y
Security Lawn and
Garden Products Co.
Faesy i, Besthoff
Incorporated

Chas. H. Lilly Co.

Green Light Company


Velsicol Chemical Co
Miller Chemical &
Fertilizer Corporation
Cre-0-Tox Chemica!
Products Company
Seacoast Labortories
Incorporated


Cotton states Chemical
Company
Land 0'Lakes
Universal Cooperatives
Incorporated
746-53
746-76
746-i 19
769-90
769-511
779-82
802-71
                                                  3.15/87
3/25/87
3/25/87
6/02/87
9. 11/67
869-14
869-188
876-63
876-86
876-100
876-104
876-233
876-281
876-303
876-304
876-305
876-306
876-308
876-309
876-310
904-135
904-223
1066-26
1066-28
1066-29
1159-102
1159-178
1339-74
1339-87
1381-51
1381-83
3/25/87
3/25/87
11/04/87
3/25/87
3/25/87
11/04/87
11/04/87
9/28/87
9/28/87
9/28/87
9/28/87
9/28/87
9/28/87
4/28/87
4/27/87
3/25/87
3/25/87
7/01/87
7/01/87
3/19/88
7/01/87
7/01/87
8/20/87
8/20/87
3/25/87
3/25/87
 1386-26
 3/25/87

-------
Dr.--:t iebach Chemical
Corporat i on
PCX, Incorporated
Griffin Corporation
Triangle Chemical
Co.-,par.y
Terrr.inix Division
of Cook Industries
Incorporated
ELCO Manufacturing Co,

Farmland Industries
Incorporated
'.•.'.R. Grace & Company

FBI-Gordon
Corporation
Hopkins Agricultural
Chemical

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

Stephenson Chemical
Company Incorporate
13i6-324
1386-353

1421-23
1598-145
1598-244

1812-242
1812-243
1S42-41
1842-42
1927-5
1927-20
1927-21
1927-49

1941-66
1990-178
1990-179

2124-742
2217-34
2217-98
2393-350
3314-73
3314-74
3442-747
3442-816
3442-846
3442-847

3772-8
4887-19
4887-48
4887-183
     d / 2 0.' 8 ~
     8/20/67

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

     7/01/87
     7/01 /8T
     5/14/S7
     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

-------
        Chemical ,
Incorporated
Coastal Chemical
Corporation

Chacon Chemical
Corporation

GRO Chemical
Company

Helena Chemical
Company
Octagon Process
Incorported

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

Sunniland Corporation

Nationwide Chemical
Products, Inc.


Ross-Daniels, Inc.

Cornbelt Chemical
Company
4931-5
' f~\ *"• i  "

-------
 ?'•::'d's Cac~ical  L
 w~> e r v i c e  inccrporsced
Hac:e:;ca Enterprises

?u.~a Chemical Company

Lre.xei Chemical Company


Flatte Chemical
Cc-pany

Falls Chemical
Cor.p£.ny


Kaw Valley, Inc.


VJilson Laboratories


Cameron M. Bairc

F-'icro-Flo Company
Garden Care  by
Farmingdale,  Ltd.
     10370-40
     10370-116
     10370-144
     10370-145

     11037-7

     11611-4

     19713-214
     19713-215


     34704-1
                          40831-5
                          40631-24

                          44215-7
                          44215-20

                          50383-20
                          50383-29

                          £0415-27

                          51036-30
                          51036-31
     53127-1
     53127-10
                         3, 28/38
                         3 • 2 fa  S £
                         3/23/83
                         3/ 28,63

                         4/27/S7

                         7/17/87

                         3/24,. SS
                         3/24/83


                         4/27/87
                        3/24/88
                        3/24/88

                        9/08/87
                        12/12/87

                        3/24/88
                        3/24/88

                        7/01/87

                        11/13/87
                        11/13/87
                         3/22/88
                         3/22/88
HEPTACHLOR
                                     ^ .T .T^TT n
COMPANY

Thompson-Hayward
Chemical Co.

Velsicol Chemical
Corporation
EPA REGISTRATION NO.
     148-964
     876-101
     876-85
     876-233
     876-308
     876-309
     876-310
                        EFFECTIVE DATE
                         6/01/87
                         4/27/87
                         9/28/87
                         11/04/87
                         9/28/87
                         4/27/87
                         4/27/87

-------
                        -7-
Cre-O-Tox Chemical
Products Corr.pany
Griffin Corporation

Triangle Chemical Co.

Terninix Division of
Cook Industries, Inc.

Stephenson Chemical
Company Incorporate


Redvood Chemical, Inc.

Red Wing Chemical
Ccrpany
                       •
.".r.'hem Corpcraticr.

Forshaw Chemical Company
Chem-Nut, Inc.

Farmco Industries
Incorporated

Micro-Flo Company
1066-28
1066-29
1066-30

1812-77

1342-183


1927-50


4887-59
4387-85

4981-17


6723-8

7122-6

7234-27
7234-31
7234-89

37686-27


46778-1

51036-50
7/01/87
3/19/8 8
7/01/87

7/01/87

5/14/87


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

 7/08/63
6/07/84

3/17/88

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

5/08/87


5/12/87

4/27/87

-------
                         APPENDIX  D
                                      N 5 ior; s
 Var.  Waters  &  Rogers,  Inc.
Chapman Chemical
Comipany

Vaccinol Chemical Company
Incorported

AJ-r.7»c Chemical Corporation
          550-106
          550-107
                              1022-502
          1353-4

          5481-223
          5481-226
          5481-50
          5481-315
                                                 EFFECTIVE  DATE

                                                 7/18/87
                                                 7/18/87
                               7/15/87
                                                  7/15/87

                                                  7/17/87
                                                  7/17/87
                                                  7/17/87
                                                  7/17/87
Carolina Chemical
Corporation

'E:ac>: Leaf Products
          5797-88
                                                   7/15/37
Company

U.S. Marketing Distributors
Southern Mill Creek
Products Company






Dettleisach Pesticide
Corporation



5837-67
5687-127
6409-13

6720-2
6720-71
6720-133
6720-176
6720-260
6720-361
6720-363

6754-9
675-3-11
6754-40
6754-64
7/16/87
7/16/67
10/21/87

7/15/87
7/15/87
7/15/G7
7/15/87
7/15/87
7/15/87
7/15/87

7/15/37
7/15/87
7/15/87
7/15/87
Mystic  Chemical  Products
          36272-3
                                                  7/15/87
 COMPANY

 Southern  Mill  Creek
 Products  Company
 Dett]ebach  Pesticide
 Corporation
                      HEPTACHLOR  SUSPDJSIONS
EPA REGISTRATION NO.
     6720-279
     6754-5
     6754-40
     6754-54
     6754-64
                                                  EFFECTIVE DATE
                                                  7/12/87
                                                  7/15/87
                                                  7/15/67
                                                  7/15/87
                                                  7/15/87

-------
P»9< Ic.
01/04/11
        STOP sii's ISS:ZD us
COSWII
          of Products Cbntainiivg
        Tdane and Heptachlor
:r  .. '  :  01 SK:ICB )ic)i2i(B)           -
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4100 HAST HASEIICTOI  BlVD
U)S ASG'LES   Cl 9002J


AHVAC CE!HlCtL COEP.
4100 EAST W.SEIRGTOH  BW
LOS &9?El!S   CA SCC2)

iHVAC C5UUC1L COIP.
4100 EAST USEI!IS?OI  Bt.TD
LOS AUGELES   CA 90023

ABVAC CHEMICAL COEP.
4100 EIST USHmroi  3179
LOS UGEUS   Ci 9002)


A! C«H!C!C COS?.
1514 ELSVEITH £7
NB?SRO!)TI    01 15(62

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fOETSSOOT!    OB (5(62
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 MIIAS   —  Tl 75220-

 BUCK LElf nOMCTS CO.
 6671 rrm ST
 ttGIl         II (0120

 BUO UIP PMOOCTS CO.
 66? i ran ST
 IKO	    1140128

 Bonn cmicu co., lie.
 2 mt in.
 mmui     n iunv

 BOIDIB.cmiCiLCO., IIC.
 2 mu m.
 10IKVILLE     B! U495

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5461  226
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5481  50
7122  121
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 58«?  67
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                                                    Cl/06/66   /  /   OS    CA
                                                    01/06/S8    /  /   09     CA
                                                    01/06/88    /  /   09     CA
                                                    01/06/88    /  /   09     CA
                                                    01/06/88    /  /   05     OE
                                                    01/06/88    /   / • 05     OE
                                                    01/Ob/8(    /   /   05    OH
                                                    ll/M/M    /  /   06    T!
                                                     01/06/18    /  /   05    I!
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                                                     11/06/68   /  /   02    5
                                                     91/06/86   /  '   02   I S
                                                    01/06/88    /  /

-------
PlQ* 10.     2
         STOP SALES ISSUED AS THE HSC1T OR SECTIOI  3(cl(2Ml
                         !js::>55 ISSUE? WE-  F:F?.A
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•:A?OLISA CEE»:CAL COB?.        5'?7  86
P... K'i. "i                                CSMBW.SE
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rC! r.V                                   C-LOSMSE


COASTAL CEEf.ICAl CO?.?.         55-49  41
r.v. VY K^                               CaLOBDME
C--:-SV:LLE     NC ^?S34


f-.-:. •:•!( 41-:                               CHLOP.:ASE


COEH S:LT CEERICAL CO.         10107 8
F.-:,e-»4ii'                               CHL03DAS-
*C:?0.t         SE 69(K'l

CBE-0-TOI CHHCtt P50D. CO.   1066  29
BOX 12598                                  CELOGDARE
ffiSPBIS        TB 38112

CP.2-0-TOX COIICii PBOD. CO.   1066  29
BOI 12598                                  HBPTACH108
HE!(?!IS        Tl 38112

DETTEL SAC! PESTICIDE COBP.    6754  11
P.O. BO! 9986                              CSLOBDASE
ATLASTA        GA 30319

DiiTTiL SACE PESTICIDE CORP.    6754  40
••.:. BOX 99:r                              CKL08DANE
ATLANTA        GA 3031?

JETTEL EACH PESTICIDi CORP.    6754  40
P.O. rOX 9986                              SEPTACELOF.
ALTAHTA        GA 30319
                                                                                         91/06/3B     '   '    1-2     R>'
                                                                                         l)i/fl6/3S     /   /    C4     SC
                                                                                                            64     T8
                                                                                         Ol/Ofc/38     /   /    04     SC
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                                                                                         fli/06/86    /  /   04     TN
                                                                                         01/06/88    /  /   C4     GA
                                                                                         'j;/Q6/8S    /  /   04     :-A
                                                                                         0: '06/85    '  /   -4

-------
Pifl* 10.     )
Oi'Oi/88
         STOP SALES ISS't'J AS Ts! USCLT 0$ SECTIOI J(clUHB)
                         isiops ISS?E: WSZE PIFSA
                              EPA MS.I   P80DOCT & CEsRICAL
7CB-AH
DETTEl 5AC:i PESTICIDE  CCE?.    6754  5
?.0. SOX 9?d?                              8KPTAC5LOR
A1TASTA        GA  ::-19

?TTT!1 EACH ?ES?I"IDi  CO?.?.    l.7?4  54
?'.0. JO? ?9tf                              CELC'RDASE
ATLAS:?.        GA  wi8

DETTEL BACE PESTICIDE  CORF.    6754  54
F.O. :?! f1?**                              EEPTACHLOR
ALTASTA        GA  iO?19

riTT-1 ?ACE PESTICIDE'CORP.    6754  64
r.C. 5C-X 99«t                              CSl-OEDMS
ATLANTA        GA  30319

:-?T:L -A": PESTICIDE  CC3P.    6"54  64
?.:.:::• --«•                              EEPTACSLOR
ALTASTA        GA  iv<19


?.C. :•:» *?ct                              CaCBMSE
ATLASTA        3A  J3il»

DE7TEL5ACK CSEKCALS CORP.     14^1  23
j*7e AFPl: VALLEY  ED.                      CEW5DMS
ATLASTA        GA  JCiiJ

:••!•:: ISTIVETRIZS              1=2   132
i45i K. 22bT:i  ST.                          C-LCSDASE
?::?.?.ASCS       CA  9e5ei
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i45i N. 228TH ST.
TC-aaiCE       CA  9C501

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T3RSA1CE       CA  90SC1

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TCP.RASCE       CA  9C5C;

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C-A-IITTE      .1'.' i*2'::

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*5'. STATE STREET                           EEPTACELCE
C-ARLOTTE      SC 2*208

FCP.SEAK CHEKIAL CO.           "24:  *9
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CHARLOTTE      SC 2*20!!

FOP.SEAK CIOICAL CO.           7234  100
t50 STATE SWEET                           CHLOKASE
CHARLOTTE      1C 28208

POasSM CH2HICAL CO.           7234  101
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«:^:I5        TS ::.:5

VAX W.TISS & P.CGSP.S             550   ..-
225t JDNCTIOS AV-S^E                       CEIOEJAS:
SAS JOSE       CA 95:31

VAS WTEHS & ROGERS             55i   ;-.'
2256 JWCTIOT AV!!i:i                       «:::F:?.S:
SAS JOS!       CA 95131

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P.O.30! 2"7 100  P MIH  ST.                  'T.:?.:AS:
H9?s:s        TS 18103

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                              Federal  Register / Vol. 52. No.  212 / Tuesday.  November 3. 1IUT  /  Nonce*
                                                                                                               4214'
I"
\
            h'-.i'i'i'i.Trli-rs buil'liiiy .il 401 V Si root
            SV\  . VV.iKhinsinn. L)C.
              The purpose of the mi-ciinj; is to
            ri \a-w th* first draft of the Risk
            !;;in;< ;r..il risk reduction
              Tin.- mi.-cinty is opi:n lo the public. Any
            mcrr.her of the public wishing to attend.
            n:jke brief or.il comments, or submit
            written comments to the Croup should
            notify Mrs. Kathleen Conw&y. Executive
            Secretary, or Mrs.  Dorothy Clark. Staff
            Secretary. (A101-F)  Science Advisory
            Board, by the close of business on
            Friday. November 20.1987. The
            telephone number is (202) 382-2552
            Terry F. Yosie.
            Dirc-J'.fr. Science Advisory Board.
              U.ite: Ocioti-r »3. 19,77.
            |FR Doc. 87-15383 F.lpd 11-1-87; 8 45 nm]
            BIUJNC CODE
1,
IFPL-32B6-1]

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

  Under Pub. L S2-463. notice is hereby
given that the Sources. Transport and
Fate SubRroup of the Science Advisory'
Do.ird's Rescnrrh Strategies
Sjbcnmmittee wi!) met I from 9:00 a.m.
to 4 00 p.m. on December 8lh at the
Hyatt Regency Hotel. International
Parkway (inside the Dallas Fort Worth
Airport), in the Conference Room. The
purpose of the Research Strategies
Subcommittee is to advise the
Administrator of the Environmental
Protection Agency on the development
of research strategies needed to enhance
the Agency's ability 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 basic.
  The meeting ii 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.
1987.
  Date: October 26.1987.
Terry F. Voile.
Director. Science Advisory Board.
|FR Doc. 87-25391 Filed 11-2-87; 8:45 tm|
BIUJMO COOt tMO-IO-N
IOPP-60011; FRL-3286-t I

Chlordane and Heptachlor
Termiticides; Cancellation Order

AGENCY: tnvironir.i-nt.il Protection
ARoncy (El'A).
ACTION: Order.

SUMMARY: Or, October 1.19B7. EPA
issued an Order accepting the voluntary
cancellation of certain chlordane and
hcptachlor tcrmiticide registrations held
by Velsicol Chemical Corporation, end
limiting the use of existing slocks of
Velsicol's chlordane and heptachlor
termiticide products outside the
company's control on August 11.1987.
Under the terms of the Order, such
stocks may be sold, distributed or used
according to their current labels until
November 30.1987. From December 1.
1967 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 April 15.1988.
FOR FURTHER INFORMATION CONTACT
By mail: George LaRocr.a. Registration
  Division (TS-767C), Office of Pesticide
  Programs. Environmental Protection
  Agency, 401 M Street SW..
  Washington. DC 204«0.
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 Velsicol's
registrations of chlordane and
heptachlor termiticide products [except
for a registration involving underground
cable treatments). Under the terms of
the agreement, certain uses of Velsicol's
tcrmiticide products were deleted from
the label and the remainder of the
registrations were converted into
conditional registrations. Under the
terms of the conditional registrations, no
further sale or distribution by Velsicol of
its affected chlordane and heptachlor
termiticide products was allowed unless
and until Velsicol satisfied air
monitoring requirements specified in the
conditional registrations. The August
llth agreement did not affect existing
stocks of Velsicol's termiticide products
outside of Velslcol's control on or before
that date (which EPA estimated at the
time to be a volume equal to
approximately 2 months average use. or
about 110.000 gallons).
  Portions of the August llth agreement
were challenged by a number of
environmental groups in a federd court
action.
  Til*- (."irt in tiiH' ,i< imn <-\\it••**> .!
i:nnt.'Tn ih.it l-'.i'O, r.i^iii h.ixr
I'niirrL'Strr.i'i'rt tin- .nr. >utv >-i i-v:,  ;:_:
aUii.k* in llut US': •>:' tlii- i-xisiir.^ :'.«. t-*
might r.onlinuL- •.i.ui-lnnlrly VYIu'.r I'.i'A
continues to bci.i.-ve lh.it its rM:n-..i'L
v.;is an uccur.itu one. Li'A .ind Yrisicui
iigrcL-d to supplement the Auuust 11 ih
up content in order lo Hlli'vuito thi:
court's concerns.
  Under the terms of the Supplement.
i.-itifiud on October 1.1967, Velsicol's
r.hlnrdnnc and heptndilor turmiticidc
registrations worn split into product
registrations containing the dc'letctl uses
and product registrations containing the
retained uses. Those registrations
containing the deleted uses were
voluntarily canceled. EPA issued ,m
Order on October 1.1937, accepting tru-
voluntary cancellation and plncing a
two-tiered cap on the use  of existing
stocks of V'elsicol's chlordane anil
heptachlor termiticide products outside
of Velsicol's control on August 11.1907.
These stocks may be sold, distributed
and used in any manner consistent with
their labeling  until November 3U. 1987.
From December 1. MS" until April 15.
1988.  these stocks 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 will be  permitted
afier April 15.1960.
   The text of the October 1st Order and
the attached Directions for Use arc set
forth  below:
   In the Mutter of The Voluntary
Cancellation of Certain Pesticide Product
Registrations Held by the Velsicol Chemical
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 11.1987. Velsicol and EPA
entered  into an agreement affecting
Velsicol's registrations of chlordane and
heptachlor products. The  agreement is
memorialized in a Memorandum of  :
Understanding and accompanying
Conditions of Registration and
Monitoring Protocol. Under the terns of
the August 11 agreement. Velsicoi
classified the following uses of its end-

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                  Federal Rcj-istnr  / Vol. 52. No.  212 / TiicsJ.iy.  \'n\u:i!., r 3. 1007  /  \olit.i-s
US'- 'i T..:'.. :iic prod.:..is JS
i. ji
   ,i  I•( sl-rr,:,<;tr:iriion ;ip|'hcjtion of
ni  .;. •: ,. f'un. vvi'h;r. .1 strut.lure
(:••-. :> :!:••;] \,\  huffirt's ('structure"):
   I,  ('fist construction apjjiu:.it:on of
rr..!1- :;j! from outside H structure 10
ir.siJc n: underneath a structure:
  c The use of pressure roddir.e for
pos!-to:is'.ruction application of material
In  :i bosen^nl-iype or crawl-space type
sln.'Cturr:
  ri. Pre- or post-construction treatment
of  the area underneath crawl-space and
post and pier type structures:
  e. Tre.i'rr.cnt of voids and spaces in
masonry cr block wahs or areas behind
venders:
  f. Applications by non-certified
er>j..iicdto:s;
  g Soil-injection pressure roddir.g at
pnissurrs greater than 25 psi.
  Thr agreement  further classified the
following USPS of end-use termiticide
products as "retained uses":
  a. Application to the outside perimeter
of any structure by trenching, or drilling
through sidewalks, patios, or other
urvT.closi'd slabs, and applying maierial
in :'.u' si):i without pressure [e.g.. flow or
gr.ivity  ffinli.
   b  App!icat:ons by the excavation
trchr.^ue !o the cxier.j: of any
<.tru:!nrp [i.e.. by  rerr."1. :ng soil next to
i"o foundation, placing on a tarp.
tre..:.r!g vv:!h tcrrrr.tiude. and placing
back :r. trench after soil dries):
   c. Piv-ror.s'.ructior. low-pressure
|n-..i.\imi:rr. 25 psi) vertical rodding (with
the dpp'::a!;on rod equipped with a
pressure control device to prevent
higher pressures) of the perimeter
outside any structure:
   d. Post-construction low-pressure
(maximum 25 psi) vertical rodding (with
the application rod equipped with a
pressure control device to prevent
higher pressures) outside slab and post
enil pier type structures:
   t. 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 pre'sures) under the
slab of slab type structures.
  The agreement classified one use. the
protection of underground cables, as an
"unaffected use".
   In addition to this classification of the
uses of Velsicol's termiticide products.
the agreement included, inter c!:a. the
following provisions:
   • The retained uses were converted to
restricted uses as provided for in
sections 3(d) and 4 of F1FRA:
   • The registrations of the retained
usi'S were amended to conditional
rujjist.Mtions. with no suit: or distribution
by Vi-Uicol ;il!:mi;d until crrt.un
conditions set fort!: in the Conations of
Rcyist'ation are net
  • No fiirthrr salt: s:r dir.lriliuli'v; In
VclsiLol of end-use products l.i!» L-d foi
deleted usi.-s w.is aiiuwrd
  • Vclsico! amended the label of its
manufacturing-use products to provide
that such products could not be used to
manufacture any end-use product (other
than Velsicol products) for sale and
distribution in the United States that is
labeled for use as a subterranean
termiticide.
  The agreemcnl became effective
immediately on August IV 1987. In
return for the conditions accepted by
Velsicol, EPA agreed, inter alia, that it
would take no action against existing
stocks  of Velsicol's products then in the
hands of applicators and distributors.
EPA estimated that a volume equal to
opproximately two-months average use
of chlordane  and hep'.achlor termiticides
(or approximately 110.COO gallons) was
in the hands of applicators and
distributors as of August 11th.
  Portions of the agreement between
Velsicol and  EPA have been challenged
in a federal court action brought by a
number of environmental groups
(MCAMP v. EPA. Civil Action No. 67-
1089-LFO. D.D.C.). The court in that
action  has expressed concerns '.hat EPA
may have substantially underestimated
the amount of existing stocks as of
August llth or that some individuals
may have large stockpiles of chlordane
products. While EPA continues to
believe that its earlier estimate of
existing stock was an accurate one. EPA
contacted Velsicol (as well as the
plaintiffs in the federal litigation) to
discuss possible amendments to the
August 11 agreement in order to resolve
the court's concern. Velsicol agreed to
amend the agreement, and on October 1,
1987. Velsicol and EAP ratified a
Supplement to the Memorandum of
Understanding (a copy of which is
attached hereto).
   Under the terms of this Supplement.
VeUicol's chloradane termiticide
registrations have been split into
product registrations containing the
dei: sd uses and product registrations
cor  ming the retained uses. Velsicol
anc ZPA have agreed to the voluntary
cancellation  of certain product
registrations, including those containing
the deleted uses (but not those
containing the retained uses), and have
further agreed to the placement of a
two-tiered cap on  the use of existing
stocks of Velsicol's products outside of
its control before August 11. These
existing stocks may be sold, distributed,
and used in any manner consistent with
their labeling until November 30,1087.
15.
l'ro:n DeC'Tiili.-r 1. 10R* tinlil Apri
V'Ull. thrsf stoics :::;iy IK- so'.;!.
distributed, arul i...i'd only in iKcnrJ.imr
•.M!,LI il;c LOl)(l;!;ni-,.s rf use prosri ihej ill
Appciiiiix A u! this Or.lcr. No use will
be prrmitlcd after April 15.  1908.
  FII'A believes the turms of this
Supplement will allow for an orderly
and efficinnt phase-out of chloridane
use. The Supplement provides sufficient
time for the use of the volume of existing
stocks estimated by EPA to exist in
August of 1907. but will prevent
unlimited use of such  stocks if EPA w;is
substantially incorrect in its estimate or
if individuals possess large stockpiles.
EPA favors a two-tiered approach
because it encourag"c the use of
application methods that are believed to
pose less potential for misapplication
and are believed less  likely to result in
indooT exposure than the uses that will
be discontinued aftjr November 30.  •
19C7.
  EPA finds that implementation  of this
Supplement is consistent with the
purposes of FIFRA and will not have
unreasonable adverse effects on the
environment. EPA has previously
determined that the agreement entered
into on August n, 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;m that which the
Agency has already found to be
acceptable.
  The Agency considers the dates set
forth herein, which were the product of
an agreement between Velsicol and
EPA. to be appropriate for several
reasons. First, the Agency believes the
dates chosen satisfy the concerns that
the Agency may have substantially
underestimated the amount of stocks in
the possession of applicators and
distributors as of Augus' 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 dales allow
for an orderly transition awoy from the
deleted uses (with such uses not  being
permitted after November 30.1937). and
eventually from all other uses (after
April 15.1988). In particular,  they
provide EPA. Velsicol. and the  National
Pest Control Association with an
adequate opportunity to notify
applicators and state enforcement
agencies  of the terms of this Order; the
dates  will not encourage a hurried use of
existing stocks which could lead to
misapplication and greater indoor
exposures: and they will allow for (he
certification of applicators (use of the

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                  Federal Register / Vol  52. No. 212 / Tui-"'!••>-.  Novpm'.K-r 3.  IfltT / N'n'.iccs
t-\ -iiin'o slocks vvil! be fl restricted usn
H« set Ic.rth in F1FRA sections 3id) and 4
.if'.-r November 30. 1987). Finally, the
(J.iius reflect iniurmution provided lo
KI'A ih;ii. even though (here may well
hint- I)'-i n only 110.000 gallons of
t-vis'ir.e stocks in the hands of
up;-.lica!nrs and distributors on August
11.1907.  the r.-tte of chlordane use has
decreased sinre ihdt date, and will of
necessity dccrnaso even further after
November 30.1907 when certain uses
wii! no longer be permitted.
  Based  on all the foregoing, pursuant to
riFKA section 6(a)(l):
  1. The  following registrations of
Velsicol's End Use Producls are hereby
cancelled:
  A. The F.nd Use Product described in
Section II.A.2 of the attnched
Supplement (that product currently
assigned EPA Registration Number 876-
233 bearing all uses of Cold Crest
Termide  other than the retained uses).
  D. The End Use Product described in
Section 11.B.2 of the attached
Supplement (that product currently
assigned EPA Registration Number 876-
63 bearing all uses of Cold Crest C-100
other than the reta-.ned uses).
  C. The End Use Product described in
Suction I1.C.2 of the attached
Supplement (that product currently
assigned EPA Registration Number 876-
104 bearing all uses of Chlordane 8EC
Termite other than the retained uses).
  D. Gold Crest C-50 (EPA Reg. No. 876-
G6).
  E. Cold Crest H-60 (EPA Reg. No. 876-
85).
  F. California SLN for crawlspace
perimeter spray (Termide) (CA-810012).
  C. California SLN for crawlspace
perimeter spray (C-100) (CA-810011).
  H. Hawaii SLN for crawlspace
perimeter spray (C-100) (HI-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 Numbers 876-63.
876-S5. 876-86. 876-104. 876-233, CA-
810011. CA-810012, or HI-650003 is
subject to the following conditions:
  A. Such product! may be sold.
distributed, and used in any manner
consistent with their labeling until
November 30.1987.
  B. Such products may be sold.
distributed, and used from December 1.
1967 until April 15.1988 only in
accordance with the provisions
contained in Appendix 1 to this Order.
  C. Such products may not be sold.
distributed, or used after April 15.1988.
  D. Any such products that have not
been uf.ed on or before April 15.1988
must be disposed of in accordance with
applicable federal, state and local laws.
  It is so ordered this> 1st d.iy of
October. 198?.
t)n:ic!.is U. Campl.
Appendix I — Voluntarily Cancelled
Subterranean Termite Control Products
Directions for Use Between December 1.
1987. and April 15. 1988
Restricted use Pesticide
For Retail Sale to and use Only by
Certified Applicators or Persons Under
Their Direct Supervision
  It is a violation of Federal law to use
this product in a manner inconsistent
with these Directions. This product may
not be used against any pests not named
in these Directions. Apply only to
establish subsurface termite control
barriers specified in these Directions.
  Contamination of public and private
water supplies must be avoided by
following these precautions: Use anti-
backflow equipment or procedures to
prevent siphonage of pesticide back into
water supplies. Do not treat soil beneath
structures that contain cisterns or wells.
Do not treat soil that is water saturated
or frozen. Consult state and local
specifications for recommended
distances of treatment areas from wells.
and refer to Federal Housing
Administration Specifications on new
construction for further guidance.
Preconstruction Subterranean Ternite
Treatment
  Effective preconstruction
subterranean termite control squires
the establishment of an unbroken
vertical and/or horizontal chemical
barrier between wood in the structure
and the potential or existing  termite
colonies in the soil. To meet FHA
termite proofing requirements, follow
the latest edition of the Housing and
Urban Development (HUD) Minimum
Property Standards.
Dilution Instructions for Cold Crest
Termide
  Use a .75% water emulsion lot
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. Use a
0.75-1.5% water emulsion for
Coptotermes spp. where necessary. Mix
1-2 gallons of Gold Crest Termide in 99
gallons of water to produce a 0.75-1.5%
water emulsion.
Dilution Instructions for Gold Crest CM 00
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 n 1-  vv.i'.er ?nu:Ui'T.  '.'>,• .\ 1-
Z o wator emulsion fur C'/'''•'•'''""-> *pl;
uhiTL1 nfcr«;:>nry Mix 1-- c.i'.i-T.s >>f
product in 93 potions uf water to
produce a 1-21. w.itrr oR>ul>..in.

Dilution Instructions for GoK! Crrst II-
00
  Use a .5% water emuUion fur
subterranean termites other lhan
Coptotermes spp. Mix 1 gallon of
product in 59 gallons of water to
produce a .5% water emulsion. Use a 1v:
water emulsion for Coptoturnit'.t spp.
where necessary. Mix 2 gallons ol
product in 59 gallons of water to
produce a le-i water emulsion.

Dilution Instructions for Cold CmM C-5U
  Use a 1% iv.iler emulsion for
subterranean termites other than
Coptotermes spp. Mix 1 gallon of
product in 47 gallons of water to
produce a 1% water emulsion. Use a 2**
water emulsion for Coptotermes spp.
where necessary. Mix 2 gallons of
product in 47 gallons of water to
produce a 27i water emulsion.
  Do not apply to soil beneath
structures which will contain subsUb or
intra-slab air ducts. Do not apply to any
area intended as a plenum air space.
Check with builder or contractor or
determine if the design of  the structure
includes these ducts or a plenum.
  Do not apply to any area inside the
foundation wall which will not be
covered by a concrete slab (e.R . bath
traps, inside surfaces of concrete or
block walls above the level of the slab).
Cover these areas during application
with polyethylene or similar material.
Do not treat into or through hollow
masonry voids.

Slab Construction

Horizontal Barriers
  Before footings are poured, horizontal
barriers may be established in footing
trenches. Treatment of the footings
through hollow- masonry voids is
prohibited. Then, after interior grading is
completed and prior to the pouring of
concrete slabs, horizontal  barriers may
be established on soil which will be
covered by concrete floor, entrance
platforms, and in other critical areas
which will be covered by concrete slabs.
  In the case of a single-pour.
monolithic slab which does not have a
separate foundation or footing, an
overall horizontal barrier would be
created before the concrete is poured.
  To produce a horizontal barrier, apply'
the emulsion at the  rate of 1 gallon per
10 square feet to fill dirt. If fill is w;ished
gravel or other coarse materitil. apply at
1'/; gallons per 10 square fret.

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             UNITED STATES ENVIRONMENTAi

                         WASHINGTON, D.C
                                                          OFFICE OF
                           CCD  Q IQQO              PESTICIDES AND TOXIC SUBSTANCES
                           ruu  & laoij

MEMORANDUM

SUBJECT:  Chlordimef orm - Stocks at Dealer/Distributor Level

                                    £•
FROM:     Phyllis E. Flaherty
          Acting Director
          Policy and Grants Division
          Office of Compliance Monitoring

TO:       Addressees
     Recently, I received a question regarding chlordimeform.
The question was:  "Would a dealer/distributor be in violation
of the Cancellation Order for Chlordimeform if a farmer pays
for chlordimeform prior to February 19 but does not physically
receive the product until after February 19,  1989?"

     Based on discussions with the Office of  General Counsel
and 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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          UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                      WASHINGTON. D.C. 20460
                           JUN I 91989
                                                       OFFICE or
                                                PISTICIDCI AND TOXIC •U«ITANCll
MEMORANDUM

SUBJECT:  Final Compliance Strategy for the Cancellation of
          Chlordimeform

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

TO:       Addressees

     Attached is the Final Compliance Strategy for the
Cancellation of Chlordimeform.  The Cancellation Order became
effective on February 19, 1989.

     This strategy is effective immediately and calls for
compliance monitoring of the cancellation order through
inspection of producing establishments, distributors,
dealers/retailers, and users of Chlordimeform products.
Inspections of distributors, dealers, and users will  be conducted
by States with Cooperative Enforcement Agreements, as part of
their routine inspections.  In those States in which  the
producing establishments are located, inspections are to be
conducted in order to monitor the recall provision of the
Cancellation Order.  Also, in Regions/States where substantial
use has occurred, States are to specifically target and conduct
inspections at the distributor/dealer level for purposes of
assuring compliance with the Cancellation Order.

     We appreciate the comments submitted on the February 15,
1989 draft of this strategy.  We have incorporated most of these
comments Into the final document.  Attached is a summary of these
comments and OCM's responses.  For your Information,  we have also
attached • copy of the February 8, 1989 FEDERAL REGISTER Notice
entitled, "Final Decision Not to Initiate a Special Review and
Decision and Order of Cancellation.*  Included as appendices to
the Strategy are a list of Chlordimeform pesticide registrants,
products, and producing establishments and a. summary of the
Chlordimeform actions.

     If you have any questions regarding the attached strategy,
please  contact Steve Howie of my staff at FTS 475-7786.

Attachments

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                                 ADDRESSEES
II
     Douglas D. Campt
     Edwin F. Tlnsworth
     Anne Lindsay
     Frederick F. Stlehl
     Mark Greenwood
     A. E. Conroy II
     Connie Musgrove
     Mike Wood
     Jerry Stubbs
     Sherry SterlIng
     David DulI
     Ken KanagalIngam
     Bob Zlsa
     John J. Neylan III
     Phyllis E. Flaherty
     Maureen Lydon
                    (H7501C)
                    (H7505C)
                    (H7505C)
                    (LE-134A)
                    (LE-132A)
                    (EN-342)
                       n
                       n
                       n
                       it
                       it
                       it
                       it
                       n
                       it
                       it
     Jake Mackenzie
     Western Regional Compliance Director
Louis F. Gltto, Director
Air Management Division

Barbara Metzger, Director
Environmental Services Division
Ill  Stephen R. Wassersug, Director  .
     Hazardous Waste Management Dlv

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

V    WIlltamH. Sanders III, Director
     Environmental Services Division

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

VII  William  A. Sprat I In, Director
     Air and Toxics Division

VIM Irwln L. Dlcksteln, Director
     Air and Toxics Division

IX   David P. Howekaap, Director
     Air Management Division-

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

Ernest Regna, Chief
Pesticides & Toxic Substances Br

Larry Miller, Chief
Toxic & Pesticides Branch

Richard DuBose, Chief
Pesticides & Toxic Substances Br

Phyllis Reed, Chief
Pesticides & Toxic Substances Br

Robert Murphy, Chief
Pesticides & Toxic Substances Br

Carl Walter, Acting Chief
Pesticides & Toxic Substances Br

Alvtn Yorke, Chief
Toxic Substances Branch

Davis Bernstein, .Chief
Pesticides & Toxics Branch

Kenneth Feigner, Chief
Pesticides 4 Toxic Substances Br
cc:  Michael Walker      (LE-134P)
     Jim Roeloffs        (TS-788)
     John Tlce           (TS-769C)
     Al Heler            (A-107)

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 RESPONSE TO ^Q^ff^TS RECEIVED RELATED TO CHr.nRDIMEFORM STRATEGY
COMMENT I;  one Region was concerned how the cancellation order-
treats the end-user who wants to "give away" a small quantity of
chlordimeform to another end-user.

     Another Region wanted to know if a dealer/distributor would
be in violation of the Cancellation Order if a farmer paid for
the chlordimeform prior to February 19, 1989 but did not receive
the product until after that date.

RESPONSE 1;  The Cancellation Order states that no one may sell
or distribute chlordimeform after February 19, 1989.  Under the
FIFRA 88 amendments, the term "sell or distribute" includes
"deliver."  Therefore, such a transfer without exchange of monies
or a prior payment and subsequent distribution would both be
considered a "delivery" and are prohibited by the Cancellation
Order.  Please refer to the memorandum sent to the Regions on
February 9, 1989 from Phyllis E. Flaherty entitled,
"Chlordimeform - stocks at Dealer/Distributor Level," for further
discussion on this subject.


COMMENT 2;  One Region suggested that OCM develop a "Compliance
Monitoring Summary" which would present all EPA cancellations,
etc, in a concise booklet which would list cancellation dates,
effective dates for discontinuation of sales, final date for use
of existing stocks, and any other pertinent facts.

RESPONSE 2:  We have added a summary (see Appendix B) for
chlordimeform which addresses this issue.
COMMENT 3;  One Region felt that the strategy should require
chlordimeform inspections to be targeted instead of allowing the
states to set their own priorities in relation to ongoing state
work.  .The commenters suggested that specific reporting of
inspections or findings should be required to be submitted to
EPA.  The commenter suggested that more responsibility be placed
on the states for some reporting response since inspections,
except for tips and complaints, are routine.

RESPONSE 3s  we have incorporated this suggestion into the
strategy by adding requirements for producing establishment
inspections and affirmative inspections in States with a history
of substantial use of chlordimeform.

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COMMENT 4!  One commenter suggested that the States be required
to check the recall provision of the Order at the registrants
production facilities and distributors, and to conduct random
inspections at a specified number of RUP dealers/distributors.

RESPONSE 4:  We have incorporated this into the strategy.  Since
the two registrants are required to conduct a recall down to the
dealer/distributor level, the States should monitor the recall
provision of the cancellation order according to Section 14 of
the Pesticides Inspection Manual (dated August 1987).
Furthermore, the recall action is to be followed up by a visit  to
the companies to check their records to determine if the recall
was successful.
      \

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               FINAL COMPLIANCE STRATEGY FOR THE CANCELLATION
                            •  OF CHLORDIMEFORM
OVERVIEW	

     Chlordimeform is present as the active ingredient in
pesticide products registered for use to control the egg and
larvae stage of Heliothis sop, on cotton.  Chlordimeform
products are also registered as yield enhancers for all cotton
growing areas based on increased cotton yields above that
expected from insect control alone.

     In 1985, the two Chlordimeform registrants, Ciba-Geigy
Corporation (Ciba-Geigy) and Nor-Am Chemical Company (Nor-Am)
were notified of the Agency's intention to commence a Special
Review of pesticide products containing Chlordimeform.  In
January 1986, the draft Registration Standard, which was made
available for public comment, stated that the Agency intended  to
put Chlordimeform in the Special Review process.  Studies with
the unmetabolized parent Chlordimeform indicated that the
compound was not mutagenic; however, metabolism of the parent
compound produced one metabolite considered moderately mutagenic
and another one considered to be strongly mutagenic.

     On January 6, 1989, the Acting Assistant Administrator for
the Office of Pesticides and Toxic Substances signed a FEDERAL
REGISTER Notice entitled:  "Chlordimeform:  Final Decision Not
to Initiate a Special Review and Decision and Order of
Cancellation."  The Agency's decision is based on the proposal,
in February 1988, by Ciba-Geigy and Nor-Am, to voluntarily
cancel all Chlordimeform registrations effective February 19,
1989.  The registrants indicated that they intended to terminate
sale and distribution after the 1988 cotton-growing season.
Furthermore, the Order cancels all registrations of pesticide
products containing Chlordimeform as .the active ingredient and
prohibits allxsale and distribution of existing stocks of
Chlordimeform in the possession of registrants, retailers, and
distributors after February 19, 1989.  Additionally, the
registrants are required, by the Order of Cancellation, to recall
all existing stocks down to the dealer/distributor level,
consistent with theii earlier proposal to the Agency.

     The Agency conducted a short term risk/benefit analysis of
the use of existing stocks of Chlordimeform in the hands of end-
users and has concluded that the benefits of one additional year
of limited use outweigh the risks of such use.  Therefore, the
Order allows use of existing stocks in the possession of end
users until October 1, 1989.

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                                    -2-
     Compliance with the Cancellation Order will be determined
through inspections of registrants, distributors, dealers,  and
users of canceled products.   Inspections are to be conducted by
States with Cooperative Enforcement Agreements and EPA in States
without Cooperative Enforcement Agreements, as part of their
current routine inspections.   In Regions/States where
substantial use of chlordimeform has occurred, States will
specifically target and conduct inspections at the distributor/
dealer level for purposes of assuring compliance with the
Cancellation Order.  If States receive tips, complaints,  or other
information indicating that use is occurring after October  1,
1989, they should target specific inspections at the user level.
REGULATED INDUSTRY	

     All registrants, producers, distributors, and users of
chlordimeform are subject to the Cancellation Order.   At the
time of the voluntary cancellation, there were two registrants,
eight registrations, and two producer establishments.   A list of
these can be found in Appendix A.

CONDITIONS OF CANCELLATION

     All pesticide products containing chlordimeform were
automatically canceled on February 19, 1989.

Recall	

     The Order requires the two registrants to conduct a recall   .
down to the dealer/distributor level consistent with their
earlier proposal to the Agency, in order to ensure that no
further quantities of chlordimeform become available to end
users.
           \
Existing Stocks	s	

   Sale and distribution of existing stocks now in the
possession of retailers and distributors is not permitted.  Such
sale and distribution was prohibited as of February 19, 1989.
Please note that section 2(gg) of the FIFRA 88 Amendments defines
the term "to distribute or sell" to mean: to distribute, sell,
offer for sale, hold for distribution, hold for sale, hold for
shipment, ship, deliver for shipment, release for shipment, or
receive and (having so received) deliver or offer to deliver.

     Ciba-Geigy and Nor-Am have indicated that they have not
marketed chlordimeform after the 1988 cotton growing season.
Both registrants are required to recall all existing stocks of
chlordiaeforai down to the dealer/distributor level.  The

-------
                                    -3-
 registrants have  also  indicated that they will accept for
 disposal  any  stocks of chlordimeform turned in by end users.
 Persons holding existing stocks of canceled 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 12(a)(2)(K).

     The  use  of chlordimeform stocks in the possession of end
 users will be allowed  until October 1, 1989;  however, such use
 must be in accordance  with the terms of the cancellation order
 and any label restrictions.

 COMPLIANCE MONITORING

     Producing establishments will be asked to verify by mail
 that production and sale for distribution within the U.S. has
 ceased,   compliance with the Cancellation Order will be
 determined during inspections at producing establishments.

     During routine inspections of dealers and users, inspectors
 are to ensure that the canceled products are no longer being sold
 or distributed or, if  after October 1, 1989, used.  Tips and
 complaints are to be investigated as appropriate.  If a State/EPA
 has reason to suspect  violations, then inspections should be
 specifically  targeted  and conducted to address any potential
 violations.

     Producer establishments are located in Regions 3 and 4;
 therefore Regions 3 and 4 have their lead responsibility for
 monitoring the efforts of Nor-Am and Ciba-Geigy, respectively, to
 recall all existing stocks and to ensure that the results of the
 recall are forwarded to EPA Headquarters.  Recall monitoring of
 existing  stocks will also be performed by Regions working in
 conjunction with the States, with priority placed on areas where
 substantial use has occurred.

 ALLOCATION OF RESPONSIBILITIES

 Office of Pesticide Programs	

Will develop  and provide OCM with a list of products affected by
 the Notice and their registration status.

Office of Compliance Monitoring	'   	

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

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

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                                    -4-
Regions	.  	

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

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

will conduct inspections in states without Cooperative
Enforcement Agreements as specified in this Strategy.

Will take enforcement actions as appropriate.

Will report information to States which indicates possible non-
compliance with the Cancellation Order, including information on
tips and complaints received.

Will specify recall monitoring provisions to the States.

Will report results of the recall and any violations to EPA
headquarters as where specified in this strategy.

states	,	"

Will conduct inspections and submit reports as agreed upon with
the Regions.

Will monitor the recall provisions of the Cancellation Order as
required by the Strategy.

Will investigate tips and complaints as received.  If States
receive information which indicates possible noncompliance with
the Cancellation Order, they, should investigate to ensure
compliance.,

will take enforcement actions, as appropriate.

In addition, States should address the chlordimeform cancellation
Order in their priority setting process for FY 90, as
appropriate.                               "

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                                     APPENDIX B
             COMPLIANCE STRATEGY SUMMARY FOR CHLORDIMEFORM CANCELLATION
AFFECTED ENTITY
Registrants/Retailers/
Distributors
Registrants
Registrants
Users
Users
REQUIREMENTS
Existing Stocks
(Sale and Distribution)
Recall
Disposal
Existing Stocks
(Use)
Disposal
EFFECTIVE
DATE
2/19/89
*
*
10/1/89
10/1/89***
. AUTHORITY
Order
Order
**
Order
**
* No effective date mentioned in the FR  Notice.
** Applicable Federal,  State, and Local  laws
    Must be disposed of after this date  but no time frame in FR Notice.

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 6242
Federal Regfrtar / Voi K N0.'s>' WtdnM
 registrants of technical chlordimebm   -
 and chiordimeform hydrochlorlda,
 ChJordimefonn. an Insecticide, is aeed
 on cotton to control Htliothit ipp.   .  '
 & Legal Background         '  .^^,.
   A pesticide product may be sold or
 distributed in the United State* only tf it
 to registered or exempt from registration
 under the Federal Insecticide. Fungicide
 and Rodenticide Act (rTFRAJ. at
 amended (7 U.S.C 138 * wo.). Before a*
 product can be registered it must he-
 shown thst il can o* used without
 "unreasonable adverse effects oo •*
 environment" (FIFRA section 3(c)(5)J.
 The term "unreasonable adverse effect*
• oa th* environment" Is defined m FIFRA
 section 2(bb) as "any unreasonable riak
 to man or the eavtnnmenU taking mte
 eccount th* economic social, and
 environmental costs and benefit of th*
 us* of any pestidde."The burden of
 proving that a pesticide meets this
 standard for registration is. it all ttmee,
 oo the proponent of initial or continued
 registntion. If at any time the Agency
 determines taat a pesticide no longer
 meets this standard, the Administrator
 may cancel this registration under .
 section Oof FIFRA.             :"....
   The Special Review process provide*
 a mechanism to permit public
 particrpetfoa m EPA's deliberation*
 prior to issuance of any Notice of Final
 Determination describing the regulatory
 action which the Administrator ha*
 selected. The Special Review procesa,
 which wet previously called th*
 Rabuttable Presumption Against
 Registration (RPAR) process, I*
 described in 40 CFR Part 154. published
 a the Federal Register of November if.
 1985 (50 FR 49015).
   The Special Review process I*
 commenced by the Issuance of a
 preliminary notification to  registrant*
 aad applicants for registration pursuant
 to 40 CFR 154.21 that the Agency la
, considering commencing t Special
 Review. If the Agency determine*, after
 Issuance of a notification pursuant to 40
 CFR 154-21. that It will not conduct a
 Special Review, it It required under 49
 CFR 154.23 to issue a proposed decision
 to be published la the Federal Register.
                                                                     tfoa require* that a period of
                                                                  man 30 days be provided for
                                                           .  .   comment on the proposed
                                                           eJsdaioo act to conduct a Special
                                                           l**jaw. Subsequent to receipt aad
                                                          • erefaaUon of comments oa the proposed
                                                          . decMua not to conduct a Special
                                                           Rvrirw, the Administrator is required
                                                           ay 4$ CFR 154.29 to publish in the
                                                           Federal Register his final decision
                                                           regarding, whether or not a Special
                                                           Review will be conducted.

                                                           C Sigulalory Hiiteiy

                                                            CMordimeform was first registered in
                                                               for use on apples. Between 1988
                                                              1978 us* on several more crips was
                                                                     including cotton. In 1978 the
                                                           registrants voluntarily withdrew
                                                           chiordimeform from the market based
                                                           aa results of a chronic mouse study
                                                           showing that chiordimeform caused
                                                           aaafignant humors,
                                                            CUordimeform was reintroduced to
                                                           ID* market in 1978 with only the cotton
                                                           es* on the label At mat time, extensive
                                                           protective clothing measures wen
                                                           reqmJred a* well as requirements for
                                                           arfidng and loading in closed systems,
                                                           redaced application rates, restricted ate
                                                           cleasiflcatioa and mining for workers.
                                                           Registrants were also required to
                                                           Implement a worker urine monitoring
                                                           program. Following th* reintroduction of
                                                           chiordimeform. the Agency received
                                                           additional positive mouse cancer studies
                                                           aa chiordiaeform and its metabolites.
                                                            Oo September 15.1985. the Agency
                                                           issued a preliminary notification to the
                                                           registrants of chiordimeform. pursuant
                                                           to 49 CFR 154.21. based on evidence that
                                                           chiordimeform caused rumors in
                                                           laboratory animals. On January IS. 1986.
                                                           a draft Registration Standard for
                                                           ddordimeform was issued for public
                                                           comment This document notified the
                                                           pabac that the Agency would initiate a
                                                           Special Review and invited comment*
                                                           from registrants and other Interested
                                                           parties. Public comment on the draft
                                                           Registration Standard was initiated
                                                           because then was a substantially
                                                           eooplete chronic health and teratology
                                                           data  base for chiordimeform (40 CFR
                                                           153J4). The Agency decided not to issue
                                                           a Federal Register notice merely
                                                           anaeundng initiation of a Special
                                                           Review but to proceed directly to a
                                                           combined Notice of Initiation of Special
                                                           Review aad Preliminary Determination.
                                                           A Notice of Preliminary Determination
                                                           eats forth both the risks and the benefits
                                                           of (he chemciaL analyze*, the risks and
                                                           benefits, discusses regulatory  options
                                                           for redadaf risk, aad proposes a
                                                           regulatory action. The Agency was
                                                           preparing a combined Notice of
                                                           taitiattoo of Special Review and

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                  Federal leggier / Vol 54.  Ho. g I Wednesday. February 8, 1989 / NoHcW
                                                                                                           1243
 Preliminary Determination whan, prler
 to fonnal initiation of • Special Review,
 on Febn^l* 198ft, aba-Cetfy and
 Nor-Am. tht only registrants «f    .::  *:
 chJordimeform, requested vohmtary
 cancellation of All ifpuifn'its rnnts.lnlrsj
 chlordimeform, effective February it,
 1969. Both companies announced their
 intent to discontinue sale tad
 diitrbution after the 1900 cotaaav
 growing ictton. about October 1. 1909;
 they indicated that they expected
 existing stocks, (boat die same amount
 tf they told in 1967, to be used up in the
 1988 growing tenon. Both companies
 also stated that they would recall any
 uauied itockj  down to the uaer level
 and would ditpose of these recalled
 «tock*. Both companies requettad
 immediate withdrawal of all tofermact*
 except for cotton: they requested ihe
 withdrawal of the cotton related
 toieranccf effective December 91. HBO.
 The Agency ha* approved aaeodmeaai
 lubnu'tted by both companies which
 place a termination daU o/Febrsory tt,
 I960 on  their chlordimafom
 registrations.
  The Agency ha* alao discussed wtTk
 the National Institute of Occupational
 Safety and Health (N1OSH] and various)
 State health agencies, a possible
 program to contact agricultural and
 factory workers expoeed to sigBifieat
 level* of chlordimeform in the pad The
 purpose of ntch notification woold be to
 inform worker* of their increased risk of
 bladder cancer, and to encourage fan
 to *eek medical attention, rach aa
 cancer screening testa,  which would
 allow early detection and treatment. Me
 deciiion haa been made yet to ponae •
 notification program.
  thi* Notice announce* that for to
 reaton* explained m the September tt\
 1988, Federal Refiater Notice (S3 FR
 36422) and summarized la Unit IV of this
 Notice, the Agency will not tnidata the
 Special Review bated on the companies'
 voluntary cancellations. The Agency ha*
 cancelled Cibs-Geigy's and Nor-Aa's
 chlordimeform registration*, effacd**
 February 19,1989. The September If,
 1888. proposed notice rantasnad a
 prohibition against the safe. dfaMbejttoa
 and use of existing stocks after February
 19.1969. Thij notice amoancn fPA"»
 decision to prohibit salt aad dUtribottoa
 after Pebraary 19. 1SB9. tnrt to allow the
use of existing stoeka m the po* session
of end users, ontil October t,1Ma\
based on comments and mforauttoa
received from asea. sUte eCBdala, asai
researchwa. which the Afeacy oa«d to •
risk/benefit analymi* of the snort  taaai
use of chlofdimeform •»«*! Ocaobar t»  ''
19a0. The raaaocs Cw gnntinf tfck
provision are also discnsaed m Uiet IV.
 A. Cbeoguuc Kill   '.'•  •    -•    '
  A prrrale sjoHficatfoa. issaed pursuant
 to 40 CFR U42L whJch begu the pn»
 Special Reriew procesa, was seat to
 chlordaaeform reglftrants because of
 Agency concerns that chlordimefarai
 exceeded the risk criterion far
 oncogenicity now specified in 40 CPR  '
 !M.7(aX2). This concern was
 specifically based on four eao«w '
 oncoMaitity studies which demonstrate
 significant dose-felalad increases to
 tumor rates in male and female mice.
 These studies are discussed at lengv n.
 the draft Chlordimeform Registration
 Standard, which can be obtained from
 the eddres* given above for
  After the private aolfllcation to     -  •
registrant* the Agency received  •
preliminary findings from •  '
retrospective mortality study of German
production workers which snugs its 4-
cblor-o-tolaidiae (S-CAT). • nMtaooRto
of chlordimeform which has beta
detected in the orina of exposed  •'
agricultural workers, may todvet
baiddar cancer in humans. The
metabolite S-CAT belongs to a class of
organic chemkale, the substituted
                tbers of which have.
been isVntified as <
  Based on animal data. fcTA and
previoajly ooochided that there •
surBdent experioeoul evidence to
classify chlordimefonn as a Bt or
probable human carcinogen, porsoant to
Agency eardnogeB assessment
gsideliaes. The rnnaan data from 
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 6244
               -.         .
/ Vol 54, No. » /  Wednesday. February * 1909 / Noffcrt
 then an significant stocks of  .. •', . >>; ,-•
 chlordimeform (thought to ba withtn % ^
 range of 10 to 25 percent of a normal   ,
 year's supply; that Is, 100.000 to 280000
 pounds) remaining ia the hands of end
 users. Thenrore. In light of the larger
 than expected stocks of chlordimeform
 in the hands of end users and tn hght of
 the comments of State pestidde offidals
 and user groups, the Agency has
 conducted s risk/benefit analysis of
 allowing the use of sxiiting stocks of
 chlordimefonn in 1989. This risk/benefit
 analysis appears In the following Unit
 QLB.
 A. Agtncy'i Retponu to Comments
  Comments wera received bom the
 following organizations and stats
 regulatory agendes:
 Arizona Agricultural Chemical
  Assodstion (1)
 Arizona Commission of Agriculture and
  Horticulture (2)
 Arizona Cotton Growers Assodstion (3)
 Arizona Farm Bureau Federation (4)
 Agricultural Council of Arkansas (5)
 Arkansas Stats Plant Board (6)
 Assodation of America Pastidda
  Control Offidals (7)
 Georgia Agricultural Chemical ' "
  Assodation (8)
 Georgia Cooperative Extension Service
  (•)
 Georgia Department of Agriculrun (10)
 Helens Chemical Corporation (11)
 Louisiana Agricultural Aviation
  Assodstion (12)
 Louisiana Cooperative Extension
  Service (13)
 Louisiana Farm Bureau Federation (14)
 Mississippi Cooperative Extension
  Service (15)
 Mississippi Department of Agricultun
  and Commerce (16)
 National Agricultural Aviation
  Assodation (17)       '     •
 National Cotton Council (18)
 North Carolina Faun Bureau Federation
  (19)                     \ .
Sundance Farms (20)
Trans-Peco* Cotton Assodation (21).
  In addition, numerous comments wara
 received from individual cotton gfowan
 and pestidde applicator*. Thaaa latter
comments an substantially tha same aa  •
those comments made by state
regulatory offldala, and an uswand to
the responses to the state regulatory
officials.              .            .  ••
  1. Comment One commenter (!) states
that the Agency doas not have legal
authority to prohibit use of a voluntarily
canceled pestidde, and that tha
Agency's proposal to not allow osa of
existing stocks Is not consistent with an
earlier proposal to allow use with
restriction*.             -     •• -    -
      X|wnc7> AasponM: b determining, j
   ,6s suras of stocks of periddea.    .  .
    voluntarily canceled pursuant to section
    •(ft. to Administrator may or may not
    permit the sale and use of existing  •••>•;
    stocks. Tha Agency is not prevented -   '
    from changing its position on use of
    existing stocks, where such can be
    Justified under FIFRA. especially when
    new conditions become relevant
    .  2, Comment Several commenten (6.7.
    0, 9.14. and 17) stated that it would be
    difficult to locate any remaining stocks
    of chlordimeform, especially if these
    stocks ara in the hands of end users,
      Agtncy't Ruponiv Tha Agency doaa
    not agree that It will be particularly
    difficult to locate existing stocks of
    chlordimeform. Both registrants have
    already contacted their dealer/  .
    distributor networks about the recall of
    chlordimeform. and have agreed to
    publicize the recall in appropriate
    newspapers and agricultural Journals la
    order to reach end users. la addition, tha
    Agency notes that chlordimeform is a
    restricted use pesticide, and that
    therefore records of chlordimeform salsa
    have been required to be kept
      X Comment Several commenten (12.
    J. 8, a, 7,10, U111117,1ft, and 21)
    stated that then is no means by which
    to dispoee of chlordimeform. or that uaa
    of existing stocks of chlordimeform
    would pose lass risk than transportation
    and disposal or that allowing use of
    chlordimeform would allow it to remain
    fat the hands of people trained in proper
    safety procedures.
      Agency '$ Retfoni* The Agency
    agrees that disposal of existing stocks of
    chlordimeform is a serious matter.
    however, tha Agency does not agree that
    then is no method available to dispose .
    of chlordimeform. It is possible to
    ioc!aarate chlordimeform. and it is this
    method of disposal that registrants have
    agreed to use, not burial in landfills. Tha
    Agency also does not believe that
    allowing personnel employed by tha
    registrants to ship and handle
    chlordimeform la order to dispose of It is
    Intrinsically riskier than allowing it to
    ba used OR through many years of
    registered use. personnel trained ia
    proper safety procedures have shipped
    •tw< handled chlordimeform la Quantities
    larger  than those expected to ba
    tavohrad la tha recall Appropriate
    protective clothing and other safety
    measures can ba employed to mitigate
    risks.         .          .. •     •    '
      4. Comment One commenter (11)
    states that then an no funds sat asida
    to Indemnify users who hav* remaining
    stocks of chlordlmefomv
      Agency'i Response: Section 18
    indemnification provisions an not
    involved ia this situation. A voluntary
                                                                            caocauation occurred hen- Than was
                                                                            us tauniaant hazard suspension as la
                                                                            required as one of the prerequisite* for
                                                                            •action 18 to ba triggered.
                                                                              8. Cematat Some commenten (41
                                                                            10k 14. and 18] expressed concern that
                                                                            stocks of chlordimeform remaining ia
                                                                            the hands of end usen an not likely to
                                                                            be turned in for disposal: aa a result
                                                                            then will be illegal use of
                                                                            chJordimefora. probably by ground
                                                                            application, which poses higher risks
                                                                            than the serial applications that would
                                                                            occur" if existing stocks of chlordimeform
                                                                            wen to be used up. Furtbermon. they
                                                                            comment that aerial applicators will
                                                                            have to turn away customers who want
                                                                            to have chlordimeform applied aerially.
                                                                              Agency's Respcnie: The Agency is
                                                                            aware of the possibility that not all
                                                                            remaining stocks of chlordimeform may
                                                                            ba nturned. and then, in the absence of
                                                                            an existing stocks provision, these
                                                                            stocks may be diverted to riskier ground
                                                                            application. However, the Agency
                                                                            believes that the efforts of the
                                                                            registrants to publicize the recall would
                                                                            result in at leaat some stocks being
                                                                            Nturned by users. If use sfter the date of
                                                                            cancellation wera illegal, the Agency
                                                                            would expect states to vigorously
                                                                            enforce tha prohibition against use of
                                                                            existing stocks. The Agency agree* with
                                                                            tha commenten that aerial applicator*.
                                                                            because of their extensive licensing
                                                                            proceduns. ara more likely to comply   .
                                                                            with the prohibition against continued
                                                                            use of chlordimeform. and that this
would possibly lead to less business for
affected aerial applicaton during 1969.
If tha aerial applicators wen not to
refuse such business snd undertook
illegal application*, in addition to
possible penalties, such illegal activity
would jeopardize such aerial
applicator's license and certification.
  «. Comment Several comments (2.3.
4. IX14,16.17.18. and 20) concerned
tha benefits of chlordimeform. arguing
that then an no alternative pesticide*
with which to replace chlordimeform, or .
that use of chlordimeform will delay
development of resistance to tha
pynthrpid insecticides.
  Agency'» Responu: The Agency
agrees that chlordimeform does have
benefits, and that these benefits will be
foregone if use of existing stocks is not
permitted. However, the Agency notes
that than an alternative pestiddes
registered for oviddal control of
Htliothit app. (methomyl and
thlodkarb). The Agency further notes
that ao data have bean provided to
show that chlordimeform delays
resistance to tha pyrathroid Insecticides.
  7. Summary of Goaumatr Comments
generally concerned tha practicality of

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                 Faderd
Voi K~No.'lB /Wednesday, February 8, 1989  / rotten
                                                                                                          •245
 retrieving and disposing of remalnm*  *
 stocks of ehJoidimefbm me rtsksof  J'
 ditpoMl and of minM of &SM stock*
 •nd the benefits of theM stocks. The
 Ageftcy don not find ay of ma
 comment* to bt compeflmg to aDowtasj
 or disallowing the OM of remaining  -
 stocks. However, in oonskfcretion of fee
 concern for the UM or BOBBM of
 remaining stocks ai expressed la  theM
 comments, EPA has conductedu
 analysis of the short-term risks ad
 benefit* regarding the possible UM of
 existing stock* of chJordimetorm in T9B9.

 B. Risk/Benefit Ajialytii of Allowing
 Uie ofExJiting Sloelu
 \. Risk* of UM of Existing Stock*  of
 ChJordimetorm
   to order for the Agency to aDow the
 use of exiiting stock* of products
 cancelled as • result of • risk/benefit
 finding. EPA most determine thai  tot
 benefit* of the UM of any existing stocks
 outweigh the risk* of such UM for the)
 period of nse. Chlordimefono
 registration* were not cancelled M •
 result of an Agency risk/benefit finding,
 but instead were cancelled TotaBtanljr
 by the registrant*. Nevertheless, tht
 Agency believe* a risk/benefit analysis
 for existing stocks 1* appropriate la this
 case because the Agency had iMoed •
 Preliminary Notification to At
 registrant* and w»s to the piaona of
 preparing a Notice of Initiation «f
 Special Review and • Preliminary
 Determination at the tine the voluntary
 cancellation was filed. Tbe Incremental
 risk of allowing an additional ye«r of   •
 DM of the existing stock* of
 chlordimefonn is calculated by drvidtag
 the lifetime risk by 70, and by dividing
 this result by tome factor renreaenHaf
 the reduced amount of chlordimefonn to
 be used The Ufetfme risk already
include* an adjustment for IS yean «f
exposure during an assumed Itfsspaa of
70 year*, because occupatioaal
exposure* are assumed to be V yearv
This  calculation assumes mat risk Is
directly proportional to the total <
of pesticida handled over tiaa. ..

                   "   .    "  T«aul-
    n a typfca! year, start 1 afflfoa to t  *
  mifiton poonda of chlcrdlmeform an
  reportedly used Based on tpedfle
  information received through the puMhu
  comments, (be Agency belieres that
  from 10 to 25 percent of mis amount of
  chlordimefonn remains available for as*
  In 1988. The»e assumptions are based on
  a limited survey of Alabama pesticide
  distributors, which confirm earlier
  estimates by State regulatory officials
  and the registrants. However, comments
  and other Information available to lha
  Agency Indicate that there may be much
  larger stocks of chlordimefonn  .
  remaining In the hands of end users; the •
  Agency cannot fully evaluate the
  accuracy of any of theM estimates.
  because insufficient Information has
  been submitted on the design of ma
  surveys used to reach these estimates.
  Therefore, tha Agency has calculated
 •risks and benefits not only for the If
  percent and 25 percent •"••i"<"g stocks
  assumption, but also on the wont case
  assumption, that la. (hat there is an
  entire typical year's supply af
  chlordlmcfann *•'"•''"'"• Jn «x
  cad UMTS. Tha Agency has reoaiwed
  little Specific 
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 !BenefiUofUseofExi*(lntStodc*Qff; 4
 Chlordimefoni.   .-..,. r  ••'."*•'o<.;-«
   The possible benefit* froea  -  >s-r.o
 chlordimeform eocrae indirectly from *»
 contribution to reducing Insect    •  f ••»
 Rsistonca^to the pyrethroid insecticide*,
 and directly from It* affect* on cotton
 yields, through it* cootroi of Av/fotDJ*
 tpp. The svailable data do not allow a
 definitive estimate of the magnitude of
 yield losses that could result from not  .
 using cnlordimefonn in 1908. Limited   .
 data indicate possible yield reduction*  -
 of 5 to 10 percent, or an average of ?&
 percent on treated acres, about the same
 as the loss estimate developed by USDA
 in its preliminary  benefits assessment, If
 other pesticide* are used In place of
 chlordimefonn.
   Using a range of 0 to 7 percent IOM on
 28 percent of the harvested cotton
 acreage (that Is. 100 percent of th*
 annual usage before cancellation), th*
 loss in benefits range* from SlO to $220
 million. Using a range of 0 to 7 percent
 yield toe* on 7 percent of die harvested
 cotton acreage (that la. 29 percent of th*
 annual usage before cancellation), tb*
 loss in benefits ranges from S3 million to
 SS4 million. Using a range of 0 to 7
 percent yield loss  on 2.0 percent of th*
 harvested cotton acreage (that is. 10
 percent of the prior annual uagejrtb*
 loss to benefit* ranges from Si million to
 $22 million. The low end of the rang*
 reflect* the greater coat of alternative
 pesticides, most likely to be methonyi
or thiodicarb in this case. The upper end
 of the range reflect* th* possible greater
efficacy of chlordimeform over
 alternative*. These benefit estimate* are
based on the small amount of data on
yield losses, and may
underestimate actual
                    over or
                   benefits.
. 3. Risk/Benefit Analysis of Use of
 Existing Stocks of Chlordimefonn
   Making the wont case assumption
 that 100 percent of a normal year**
 supply of chlordimeform remain* in the;
 hands of users, that la, 1 million pound*.
 th* incremental risk from one additional
 year1* use of chlordimeform to mixer/
 loaders is in th* 10~4 to 10"• range, and
 to applicators i* 10~*. A* shown In Table
 2. individual risk* from on* more year of _
 use under any of th* probabl* as*
 scenarios are low. The Incidence of  •__
 cancer in the exposed group, a*   .  *'_
 predicted by this assessment would b*
 negligible, because of the small number
 of applicators and mixer/loaders who •
 handle chlordimeform. Benefits under
 the various scenario* range from SI to
 S220 million. Given the minimal risk and
 ma possible substantial benefit*, th*	
 Agency conclude* that the 0*0 of
 existing stock* of chlordimefonn In th*
                                            growing MUOB doe* oof MOT ^ '.-
                                           ••enabled*!*. However, because; ^
                                              nek from M year* of   .,<, ^..^
                                       occupational exposure I* high, estimated
                                       to be l to a ion, and becaua*    -;..-,£
                                       epidemJoJoftcal data suggest •     .-  ,1
                                       correlation between exposure to the V
                                       CAT metabolite of chJordimefonn and
                                       excess incidence of bladder cancer, the
                                       Agency believes long term risks would
                                       be unacceptable.               ;.,.'.
                                         The Agency la requiring th*'   •' '•''
                                       registrant*, Qba-Ceigy and Nor-Am, to
                                       conduct their recall program* down to
                                       th* dealer/distributor level In order to
                                       be sure that no further quantities of
                                       chlordimefonn become available to and'.
                                         A* mentioned previously, the EPA ha*
                                       held discussions with other Federal and
                                       Slate agencies regarding the possibility
                                       of notifying factory and agricultural
                                       workers who were exposed to
                                       significant levels of chlordimeform over
                                       long periods of time of their elevated
                                       risk of bladder cancer. EPA believe*
                                       that factory workers' level of exposure
                                       to chlordimefonn was substantially
                                       higher than mat to mixer/loaders or
                                       applicator*, possibly resulting in a*
                                       much a* two orders of mconi tad*
greater risk Thus. EPA believes H a?
reasonable to aOow limited exposure of
mixer/loader* and applicators for aa
additional year. Nevertheless, EPA
support* the voluntary urine monitoring
program offered by the registrant* to •
mixer/loaders and applicator*.
IV. Agency'* final Dedsioo Regarding
Special Review
  All cUordimefonn registration* have
been amended so that they terminate
February 10. 1980, The Agency received
no comment* objecting to It* proposed
decision not to initiate a Special Review
of chlordimeform. Therefore, ihe Agency
will not initiate a Special Review of the
use of chlordimeform oo cotton. The
only (MO* resulting from the Agency**
proposal we* the objection to the
prohibition of the use of existing stock*
IB torn    .       ..      .    ......
  The agency ha* conducted a short
(arm risk/benefit analysis of thc.use of
        f Infirm gf chlordlfflefomi to *fat
                                       hand* of end users and concluded that
                                       tfkt benefit* of one additional year of  -
                                       Halted o*e outweigh the risk* of such
                                       ••a. Therefore, the use of chlordlmefomi
                                       •ttcfca En die possession of end user*
                                       will be permitted until October 1 1008.
                                       Such u*e must be in accordance win all
                                       label restrictions. Any further sal* or
                                       distribution of existing stock* or    ? .""
                                       recalled stock* by registrant*.     ;•"•''   -:
                                       distributors, or retailers Is prohibited
                                       after February 10. 1880. AD use of
                                       chlordimeform after October 1 1080, fa)  '"
ffoUbNed, Boa njUtrut* indicated
•Of hr*oot marketed chlordimsform
after the IOM cotton season, around th*
beginning of October 1908. Both
registrant* also Indicated that dtty wifl
recall afl existing stocks of
chlordimeform down to the dealer/
distributor Wvel and will accept for
dUposal any stocks of chlordimefonn
turned in by end user*.
  While the Agency has serious
concents about the long-term risk*
associated with chlordimeform us* on
cotton, it will not Initial* • Special
Review of chlordimefonn because all
use. and therefore exposure, will end at
die end of the 19M cotton-growing
season. Th* cancellation* will become
effective automatically on February 10.
1009. The Agency has acted In reliance
on the voluntary cancellation by
proposing revocation of non-cotton
tolerance* and by not initiating  a
Special Review.
  Th* Agency haa other tools that may
be available to it under FIFRA to take
regulatory action regarding
chjordimefonn, Including initiation of
Special Review and subsequent
initiation of cancellation proceeding*.
immediate Initiation of cancellation  . .
promfdingSi suspension, and emergency
suspension. A* compared with initiation
of Special Review followed by initiation
of cancellation proceedings, or
Immediate initiation of cancellation
proceeding*, the action  announced here
reduce* risks faster than would occur
under those other more  time-consuming
approaches. Finally, th* Agency doe*
not believe that th* appropriate test* for
either suspension or emergency
suspension have been met

V.fttbhc Record

  Th* Agency ha* established a public
record (public docket *30000/32J for the
chlordimeform Special Review. Thi*
public record includes:
  l.Tm* Notice,
  2. The draft Registration Standard.
  1 Any other notice* pertinent to the
chlordimefonn Special Review.
  4 Documents and copies of written
oomnMints submitted to th* Agency in
response to the pre-Special Review
registrant notification, the draft
Registration Standard, this Notice, and
any other notice regarding
chlordimeform submitted at any time
during the chlordimeform Special
Review process by any person outside
                                                                             1   I, Analysis of comments received m
                                                                              response to me draft Registration
                                                                              Staadard and the preliminary
                                                                              notification to regJstruts.

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Fed«f»J
                                  / Vol
                  , , r^a^.f--
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 jr—"t,

i f±  *i
      "J    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

       ^                WASHINGTON, DC. 20460
                                                          or net Of
                                                   PBtTICIDCS *NO TOXIC iU«»TANCt%
 MEMORANDUM


 SUBJECT:  Final Compliance Monitoring
           Strategy for Compound 1080 Livestock
           Protection Collars

 FROM:     A. E. Conroy II, Director
           Office of Compliance Monitoring (EN-342)

 TO:       Addressees

      Attached is the final Compliance Monitoring Strategy for
 Compound 1080 Livestock Protection (LP)  Collars.  This
 document reflects the strategy for monitoring compliance with
 the provisions of the labeling for registered Compound 1080
 LP Collars.

      Note that only one federal pesticide registration has been
 issued (EPA Registration Number 6704-85) for Compound 1080 LP
 Collars, that being to the U. S. Department of the Interior,
 Fish and Wildlife Service (FWS).  The registration was issued
 conditionally under section 3(c)(7) of the Federal Insecticide,
 Fungicide and Rodenticide Act.  To date, FWS does not intend  to
 train or certify LP Collar applicators,  or to distribute LP
 Collars to rancher applicators.  The FWS will assist in State
 training programs, but expects most LP Collar use to proceed.
 without FWS Involvement.  Wyoming is currently seeking a separate
 registration for the LP Collars.  Copies of the Cancellation
 Order and the subsequent documents are available upon request.

      The Office of Compliance Monitoring (OCM) received the
 following comments on the draft strategy.
 —     m
      One Regional Office suggested that  when state governmental
 agencies are the registrants of LP Collars, EPA should maintain
 the responsibility for producing establishment and agent
 Inspection? so the States are not placed in a position of
 having to regulate themselves.  OCM agrees with this and has
 modified the strategy accordingly.

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                              -2-
     One Regional Office ..requested that the Regions submit annual
rather than quarterly Inspection/violation reports to OCM because
quarterly reports are not necessary.  OCM has considered this
comment and has retained the quarterly Regional  reporting.  This
reporting 1s needed due to the. sensitivity of the issue and the
new approach to pesticide use imposed by the courts.  Therefore,
we need to closely monitor the use of the LP Collars during the
period of conditional registration.

     One Regional Office requested that each appropriate group
notify OCM/Regions/States when any registrations change including
changes in the registrants and agents thereof.  OCM has
considered this comment and has  modified the strategy
accordingly.

     One Regional Office suggested that the strategy Include a
statement for States to develop  amendments to State plans to
Include LP Collar certification  and coordinate the activity with
the Regional Office.  OCM agrees with this comment and has
modified the strategy so that States shall develop such
amendments when it 1s appropriate.

     Thank you for your comments on the draft strategy.   If you
have any questions concerning this strategy, please call Richard
Green of my staff at (FTS) 382-5567.

Attachment

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Addressees
Douglas Campt    (TS-766C)
Phil Gray        (TS-767C)
Jim Lamb         (TS-788)
Terrell Hunt     (LE-134A)
Stan Abramson    (LE-132A)
Ken Shiroishi    (EN-342)
John J. Neylan III  "
Dexter Goldman      "
Phyllis Flaherty
John Martin
Ralph Turpin        "
Mike Wood

Dr. John Mackenzie
Western Regional  Compliance Director

A. Charles Lincoln
Eastern Regional  Compliance Director

Louis F. Gitto, Director
Air Management Division, Region I

Barbara Metzger,  Director
Environmental Services Division,  Region  II

Stephen R. Wassersug, Director
Hazardous Waste Management  Division, Region  III

Winston A. Smith, Director
Air, Pesticides and Toxics  Management Division,  Region  IV

William,H. Sanders III, Director
Environmental Services Division,  Region  V

William B. Hathaway, Director
Air, Pesticides and Toxics  Division, Region  VI

William A. SpratUn, Director
Air and Topics Division, Region VII

Irwln L. D1ckste1n, Director
Air and Toxics Division, Region VIII

Harry SeraydaHan, Director
Toxics and Waste Management Division, Region IX

Gary 0'Neal, Director
Air and Toxics Division, Region X

cc:  Regional Pesticides and Toxic Substances Branch Chiefs

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   FIFRA COMPLIANCE MONITORING STRATEGY



                   FOR



COMPOUND 1080 LIVESTOCK PROTECTION COLLARS
     ENVIRONMENTAL PROTECTION AGENCY





OFFICE OF PESTICIDES AND TOXIC SUBSTANCES





     OFF'ICE OF COMPLIANCE MONITORING

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            FIFRA COMPLIANCE MONITORING  STRATEGY  FOR
           COMPOUND  1080,. LIVESTOCK  PROTECTION  COLLARS
 Office  of  Pesticide  Programs
 Office  of  Compliance Monitoring
 Regional  Offices
 Office  of  Training and Technical Support
  States
                                                             PAGE
REGULATED INDUSTRY
MFIITO&I AUHINIStRATlVE I_NbPE
 7
 6
8-9
 9
 9 '

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             FIFRA COMPLIANCE MONITORING STRATEGY FOR
             COMPOUND 1080 LIVESTOCK PROTECTION COLLARS
 OVERVIEW
      The  following points highlight the inspection activities  and
 major  new  requirements.

 0     State/EPA inspectors will conduct annual inspections of
      producing establishments, registrants, and agents thereof
      as long as registrations are conditional and thereafter
      according to the routine pesticide inspection scheme.

 0     State/EPA inspectors will conduct use and records
      inspections of applicators according to the schedule herein.

 0     Specific certification is required to use Compound 1080  LP
      Collars.  States must amend their State plans to include
      specific Compound 1080 LP Collar certification in order  for
      the LP Collars to be used within the State.

 0     Applicators are required to keep records and report certain
      information.  Applicators are required to inspect each LP
      Collar in use on a weekly basis.

 0     Warning signs are required to be posted.

 0     Registrants and agents thereof are required to keep records.

 BACKGROUND

      The Livestock Protection (LP) Collar (also called the "toxic
 collar") for protecting sheep (Ovls spp.) and goats (Ca'pra spp.)
 from  depredating coyotes consists of a flat rubber container
 holding a  liquid toxicant which 1s attached with straps around
 the throat of a sheep or goat.  Sodium Monof1uoroacetate,
 commonly called Compound 1080, 1s the only pesticide registered.
 in the United States (U.S.) for use in LP Collars.  Compound
 1080, once Ingested (or absorbed through open wounds) in lethal
 doses, causes loss of cardiac or respiratory function and
eventually, death.

     On March 18, 1972 (37 FR 5718) the use of Compound 1080
 for pcedator control was cancelled and suspended.

     Administrative Law Judge Spencer T. Nlssen, in a 1982
 decision a/id Lee M. Thomas, who was designated by the
 Administrator to rule on his behalf in a 1983 decision/1,
 allowed for applications for registration of Compound 1080 in LP
Collars subject to certain restrictions described herein.  These
 decisions constitute modifications of the terms and conditions
of the 1972 Cancellation Order.

 /I  Initial (FIFRA Docket No. 502, October 22, 1982) and final
    decision (49 FR 4830, February 4, 1984) in the matter of
    "Notice of Hearing on the Applications to Use Sodium
    Fluoroacetate (Compound 1080) to Control Predators."

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                               -2-
     On July 11, 1985 the Office of Pesticide Programs  (OPP)
issued the first registration (EPA Registration  Number  6704-85)
for Compound 1080 LP Collars to the Fish and Wildlife  Service.
Federal Registration Requirements under FIFRA Section  3

     The requirements listed below (numbers  1-18)  appear  verbatim
in the technical bulletin which are part of  the  accepted
labeling.  Only the numbers with asterisks  appear  in Judge
Nissen's initial decision which are part of  the  Cancellation
Order.  In comparing attachment C of the initial  decision
(affirmed by the final  decision) with the asterisked numbers
below, note that some of the language in the initial decision  is
less restrictive.  However, Judge Nissen indicated that  to  effect
a practical program, EPA could use its discretion  to  impose more
stringent modifications to his requirements  if it  was  deemed
appropriate.  Please note that these requirements  reflect  the
label on the one registered product and that other products
registered for this use in the future may not have the same
requi rements.

1.*  Use of Livestock Protection (LP) Collars shall conform to
all applicable Federal, State and local regulations.

2.*  LP Collars shall be sold or transferred only  by  registrants
or their agents/2, and  only to certified LP Collar
applicators.  LP Collars may be used only by specifically
certified LP Collar applicators or persons  under their direct
supervision.

The certified applicator 1s responsible for assuring  compliance
with all restrictions.   The certified applicator will  determine,
in accordance with label directions, when and under what
circumstances LP Collars will be used.  The certified  applicator
will either apply LP Collars or be physically present  where
collarsxare applied by  a noncertified person.  However,  the
noncertified person who has received instructions  from the
certified applicator may store LP Collars,  check LP Collars in
the field, remove LP Collars, repair or dispose of damaged LP
Collars In accordance with use restrictions, retrieve  LP Collar;,
lying In the field, and properly dispose of contaminated material
and animal carcasses.
12  As a condition of registration, the registrant must submit to
    OPP the names of agents.

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                               -3-


 3.*   Certification of applicators shall be performed by
 appropriate  regulatory agencies.  Prior to certification, each
 applicator shall receive training which will  include, but not
 limited  to:

 (a)   training in safe handling and placement  of LP Collars;
 (b)   training in disposal of punctured LP Collars, contaminated
      animal  remains, and contaminated vegetation and soil;
 (c)   instructions for practical treatment of  Compound 1080
      poisoning in humans and domestic animals;
 (d)   instructions 1n recordkeeping.

 4.*   At  their address of record, registrants  or their agents
 shall  keep records of all LP Collars sold or  transferred.
 Records  shall include name, address, and state where LP Collar
 certification was issued, certification number of each recipient,
 and dates and numbers of LP Collars sold or transferred.

 5.*   Each certified applicator shall keep records of use and the
 results  of use in accordance with State and Federal regulations
 for a  period of not less than two years following disposal or
 loss  of  LP Collars.  The records shall Include, but are not
 limited  to:

 (a)   the number of LP Collars attached on livestock;
 (b)   the pasture(s) where collared livestock  were placed;-
 (c)   the dates of each inspection, attachment, and removal;
 (d)   the number and locations of livestock found with
      ruptured or punctured LP Collars and the apparent cause
      of  damage;
 (e)   the number, dates, and approximate location of LP
      Col lars 1 ost;
 (f)   the species, locations, and dates of all suspected
      poisonings of humans, domestic animals or nontarget wild
      animals resulting from LP Collar use.
          \             '
 6.*   Any suspected poisoning of threatened or endangered species
 must  be  reported within 3 days to EPA as must each accident  or
 injury to humans, domestic animals, or nontarget wild animals
 from  LP Collar use.

 7.*   Only the registrant or the manufacturer 1s permitted to
 fill  LP Collars with Compound 1080 solution.   Compound 1080
 solution m»y not be removed from LP Collars and used for any
 other purpose..

 8.* LP Collars shall only be used to take coyotes within fenced
 pastures no  larger than 2,560 acres (4 square miles).  But where
 average  annual precipitation does not exceed  20 Inches and
 vegetation 1s sparse, consisting only of short to mid-height
 grasses  and  scattered shrubs, collars may be used up to a
maximum  of 10,000 acres (16 square miles) in  size.

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                               -4-
     Fenced pastures Include the grazing land that  1s  enclosed  by
livestock fencing.  This" 1ncludes wire or other man-made  fences
such as rock walls, and natural  barriers such as escarpments,     '
lakes, and large rivers that will prevent escape of livestock.
Collars shall not be used on unfenced, open range.

     In no case shall the applicator place collared livestock  in
any pasture where compliance with other use restrictions  such  as
monitoring is impossible; in fenced pastures larger than  10.UOO
acres; or unfenced open range.

9.  IP Collars shall be used only where losses of  sheep or  goats
due to predation by coyotes are  occurring or, based upon
experience, where coyote predation can reasonably  be expected  to
occur.

10.* Where LP Collars are in use, each logical point of
access (i.e., roads, gates, and  trails) shall be conspicuously
posted with a bilingual (English/Spanish) warning  sign not  less
than 8" x 10" in size.  Such signs shall be inspected  weekly  to
insure their continued presence  and legibility, and will  be
removed when LP Collars are removed.  The signs will have a
minimum type size for DANGER-POISON of 24 point (1/4 inch)  with
remaining text at least 18 point (3/16 Inch).

11.* Each LP Collar 1n use shall be inspected by the applicator
at least once every seven days and LP Collars adjusted if
needed.

If any collared animal 1s not  located in two consecutive
checks, an Intensive search for  the animal 1s required.

In addition, if more than three  collared animals cannot  be
located during any one check,  an Intensive search for  the
animals is required.

If more than nine collared animals cannot be located during
any 60\day period, remove all  LP Collars from animals  and
terminate use of collars.  Do  not resume use until  adequate steps
are taken to prevent further excessive loss of LP Collars.

12.* Damaged, punctured, or leaking LP Collars shall be removed
from the field fop repair or proper disposal.  Damaged LP Collars
shall  be placed Individually in  leakproof containers while
awaiting repair or proper disposal.  Authorized LP Collar repairs
are limited to minor repairs of  straps or fastenings.   Leaking
or punctured LP Collars must be  properly disposed.

-------
                               -5-
 13.* Dispose of Compound 1080 wastes (punctured, leaking,  or
 otherwise irreparable, damaged IP Collars; contaminated leatner
 clothing, animal remains, wool, hair, vegetation, water, and
 soil) under three feet of soil, at a safe location,  preferably
 on  property owned or managed by the applicator and at least  1/2
 mile from human habitations and water supplies.  No  more than  10
 LP  Collars may be buried in any one hole.  If buried in a  trench,
 each group of 10 LP Collars must be at least 10 feet apart.

 Alternatively, contact your State Pesticide or Environmental
 Control Agency or the Hazardous Waste representative at the
 nearest EPA Regional Office for guidance in disposing of wastes
 at  approved hazardous waste disposal facilities.

 When snow or frozen ground make on site disposal impractical,  up
 to  one cubic foot of wastes may be stored in a leakproof
 container, in a dry, locked place for up to 90 days.

 Triple rinse metal  and plastic containers with water.  Then
 puncture and dispose of container and rinsate as above.

 14.* All persons authorized to possess and use LP Collars
 shall store them under lock and key 1n a dry place away from
 food, feed, domestic animals, and corrosive chemicals and  in
 outbuildings or outdoor storage areas attached to, but separate
 from, human living quarters.

 15.  The number of LP Collars used shall be the minimum,necessary
 for effective livestock protection.  For pastures of the
 following size classes, do not use more LP Collars than the
 number indicated:

                Size (acres)    Number of Collars

                  up to  100             20
                 101 to  640             50
                 641 to  10,000         100

 16.  Each applicator shall have a 1-ounce bottle of  syrup  of
 Ipecac available when attaching, inspecting, removing, or
disposing of LP Collars.

 17.  No contaminated animal shall be used for food or feed.

 18.  The tse of 1080 LP Collars may not be used in the following
areas due to potential adverse effects to endangered species.

        Counties

        Fresno, Kern, King, Los Angeles, Monterey, San Benito,
        San Luis Obispo, Santa Barbara, Tulare, and Ventura

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                               -6-
The 1080 LP Collar may not be used in the following areas  without
written approval from the nearest U.S. F1sh and Wildlife  Service
(FWS) Office (Endangered Species Specialists).  If the FWS or  the
user determines that the- use of the LP Collar may adversely
impact an endangered species in the specific areas requested,
the collar may not be used in these areas.  Written approval
must be obtained annually.
State   Counties
CA      Alameda, Contra Costa, Merced,
        San Joaquin, Santa Clara, and
        Stani slaus

ID      Bonner, Boise (north of State
        Highway 21), Boundary, Clearwater,
        Custer (north of local road
        running from Sun Valley to Chilly
        and a corresponding line running
        northeast from Chilly to
        Patterson), Fremont, Idaho,
        Lemhi, Shoshone, and Valley

MT      Beaverhead, Carbon, Flathead,
        Gallatin, Glacier, Lake, Lewis
        and Clark, Lincoln, Madison,
        Missoula, Park, Pondera, Powell,
        Sanders, Stillwater, Sweet Grass,
        and Teton

WA      Pend Orellle, Okanogan, (Nat'l
        Park and Forest Land), Skagit,
        and Whatcom

WY      Fremont, Hot Springs, Park, Sublette,
        Teton and Yellowstone Nat'l Park
                                       Nearest FWS  Office
                                       and Phone  Number

                                        Sacramento,  CA
                                        916-484-4935
                                        Boise,  ID
                                        208-334-1806
                                        Helena, MT
                                        406-449-5225
                                        Boise,' ID
                                        208-334-1806
                                        Helena, MT
                                        406-449-5225
Because of possible adverse. Impacts on the Eastern Timber Wolf,
the nearest FWS Endangered Species Office must be notified before
LP Collars are used 1n these areas.
MI


MN
WI
Keweenaw (Isle Royal) and
entire upper peninsula

A>tkin, Becker, Beltrami,
Carlton, Cass, Clearwater,
Cook, Crow W1ng, Hubbard, Itasca,
Kittson, Koochiching, Lake,
Lake of the Woods, Mahnomen,
Marshall, Pennlngton, P1ne,
Roseau, and St. Louis

Douglas, Florence, Lincoln,
Oneida , and Price
Twin Cities
612-725-3576

Twin Cities
612-725-3576
Twin Cities
612-725-3576

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                               -7-

REGULAtEi)  INDUSTRY         ~~~I
 0    Registrants of federally registered LP Collars
     containing Compound 1080.

 0    Agents under the control of registrants described
     above which sell or transfer Compound 1080 LP Collars  -
     (registrants are required to submit names and addresses  of
     their agents to OPP after registration's issued).

 0    Certified applicators and persons under their direct
     supervi sion.

 NTUTRTl'ADMINISTRATIVE INSPECTION SCHEME

     For each Compound 1080 Collar registration issued,  State/EPA
 inspectors will inspect annually all  producing establishments,
 registrants, and agents thereof which distribute, sell,  offer
 for sale, ship, deliver for shipment, or receive and (having  so
 received) deliver or offer to deliver the products.

     In States where Compound 1080 LP Collars certification is
 issued, State/EPA inspectors will conduct use and records
 inspections of applicators who have received certification  for
 Compound 1080 LP Collars during that  year and who have also
 purchased LP Collars.  State/EPA inspectors can obtain
 information regarding applicators' purchases from registrants or
 their agents.  These inspections should cover as many applicators
 as possible so long as the annual number of Inspections  does  not
 exceed a maximum of 10% of the annual resources allocated  for
 use inspections.  Any applicators which were not inspected  during
 the year they were certified shall be targetted for inspection
 the following year until all applicators are eventually
 inspected.  Use on federal property shall be Incorporated  into
 the targetting scheme.

     These inspections shall continue annually as long as  any
 registrations remain conditional for  the submission of data
 described 1n the original  registration notice.  Thereafter,
 Inspections will be performed upon request from OPP and  as  part
of the Region/State routine pesticide Inspection scheme.  Tips
and complaints will receive highest priority for Inspections.

 PROGRAM MANAGEMENT & ALLOCATION OF RESPONSIBILITY

Office offPestldde Programs (OPP)	

 OPP's Registration Division (RD) shall:

o    Provide OCM with copies of labels for each Compound 1080 LP
     Collar registration and names and addresses of registrants
     and agents thereof.  Also, OPP will provide OCM a copy of
     the original registration notice Including any conditions
     of registration and will provide OCM with any changes in
     registrations changes in registrants or agents thereof.

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                               • 8-


Office of Compliance Monitoring (OCH)
OCM wi 11 :
     Provide copies of labels for each Compound  1080  IP  Collar
     registration, registration notices,  and  names  and addresses
     of registrants and agents thereof to the Regions  for
     distribution to the States.

     Notify Regions when any Compound 1080 IP Collar
     registrations change including changes in registrants  and
     agents thereof.
Regions
The EPA Regions will:

0    Assure that States participating in the F1FRA Cooperative
     Enforcement Agreement Program conduct producing
     establishment, agent, and use inspections for compliance
     with the labeling 'requirements.

0    When State governmental  agencies are the registrants  of
     Compound 1080 LP Collars, EPA will  conduct establishment
     and agent inspections for those  products (I.e.,  Wyoming).

0    Conduct use and records  Inspections of certified applicators
     (who have received Compo'und 1080 LP Collars), registrants,
     and agents thereof for compliance with the labeling
     requirements in States without primacy.

0    Provide copies of labels for each Compound 1080  LP Collar
     registration, registration notices, and names and addresses
     of registrants and agents thereof for distribution to the
     States or field inspection offices.

0    Distribute 11st of establishments which produce  Compound
     1080 LP Collars to the States.

0    Conduct Import Inspections (1f appropriate).

0    Develop a 11st of registered Compound 1080 LP Collar
     producing establishments and distribute to the States.

0    Report lists of EPA/State Inspections/violations for
     Compound 1080 LP Collars to OCM quarterly.

0    Take appropriate enforcement action for violations in States
     without primacy and in response to State referrals.

-------
                               -9-
0    Submit to OPP any reports of suspected poisoning of
     threatened or endangered species immediately after the
     report is received.

0    Take the lead in the development of the EPA programs  to
     certify Compound 1080 LP Collar applicators.

0    Refer any Compound 1080 LP Collar Incident reports to the
     States for followup action.  Allegations or indications  of
     Compound 1080 LP Collar misuse shall  be tracked  as
     significant cases under F1FRA §27.

0    Review any changes 1n State plans to  Include Compound 1080
     LP Collars and solicit assistance as  needed from OPTS.

Office of Training and Technical Support (in OPTS)	

0    Provide assistance to Regions in amending State  plans to
     include certification of Compound 1080 LP Collar applicators.

States	;	:	

Participating States Mill:

0    Develop amendment to State plans to Include certification  of
     Compound 1080 LP Collar applications  in coordination  with
     the EPA Regional office, as appropriate.

•    Conduct certification and training for LP Collar
     applicators provided State plan for certification 1s
     approved, as appropriate.

0    Develop a training program for LP Collar applicators
     coordinated with U.S. Department of Agriculture, Science and
     Education Administration (SEA), and the Regional EPA  Offices.

0    Conduct use and records Inspections of agents* of
     registrants and certified applicators (who have  received
     Compound 1080 LP Collars) for compliance with the labeling
     requirements and any SSURO Issued within the State.

0    Conduct producing establishment Inspections*.

0    Takt enforcement actions for violations or refer violations
     to EPA.

0    Conduct Import inspections as requested by the Regional  EPA
     office.
     EPA will conduct producing establishment and agent
     Inspections for Compound 1080 LP Collar registrations when
     State governmental agencies are the registrants.

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          UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                      WASHINGTON, D.C. 20460

                            OCT 20
                                                        OFFICE OF
                                                 PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM

SUBJECT:  Final Compliance Monitoring Strategy
          for Daminozide

FROM:     A. E. Conroy II, Director
          Office of Compliance Monitoring (EN-342)

TO:       Addressees
     Attached is the final Compliance Monitoring
for the plant growth regulator daminozide (ALAR)
preliminary strategy was transmitted for comment
1985.  This final strategy reflects data call-in
modification requirements but does not include a
intent to cancel as was originally described in
strategy.
 Strategy
   The
 in November
 and label
 notice of
the preliminary
     The Assistant Administrator for the Office of Pesticides
and Toxic Substances stated on January 22, 1986 that the
continued use of daminozide would be permitted provided the
registrant (Uniroyal) submitted certain data, modified the
labeling for one product, and agreed to a production limit for a
newly registered product for use on grapes only.

     Uniroyal has submitted and the Agency has accepted the
revised labeling (attached).  The Agency has also registered a
new product for grapes.  Uniroyal has agreed to provide data
which are based upon an established schedule which is tracked by
the Office of Compliance Monitoring (OCM).
     Thank you for your comments on the preliminary
If you have any questions concerning this strategy,
Richard Green of my staff at (202) 382-5567.
    strategy.
    please call
Attachments

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                      DATA CALL-IN SCHEDULE


DATA TYPE                                     SCHEDULED DUE DATE

Plant Metabolism Study                              08/31/87

Livestock Metabolism Study                          08/31/87

Livestock Feeding Study                             08/31/87

Crop Feeding Trials                                 05/31/87

Storage Stability Study                             08/31/87

Degradation of UDMH to Daminozide                   08/31/87

Isotope Dilution Method for UDMH                    08/31/86

UDMH Analytical Method                              11/30/86*
 * 4 months extra time provided to Uniroyal if
   data cannot be evaluated by the round robin method

Daminozide Analytical  Method                        11/30/86

Comparison of UDMH Methods of Analysis              05/31/86

Market Basket Surveys                                07/15/86,
                                                    10/15/85,
                                                    02/15/87

Greenhouse Worker Exposure Study                    12/31/86

Dislogable Residue Study                            12/31/86

Glove Permeability Study                            12/31/86

Metabolism Study                                    02/14/87

Dermal Absorption Study                             12/15/86

Mammalian Cell Gene Mutation Study                  12/15/86

Mammalian Cell Chromosomal Aberration Study         12/15/86

Bacteria DNA Repair Study                           12/15/86

UDMH Rat 12 Month Sacrifice Data                    01/15/88
         Final Report                                05/15/89

     Mouse 8 Month Sacrifice Data                   07/15/87
     Mouse 12 Month Interim Report                  01/15/88
     Mouse Final Report                             05/15/89


NOTE: Dates may change due to OPP/OCM approved requests for
      schedule modification

-------
Addressees

James Lamb       (TS-788)
Terrell  Hunt     (LE-134A)
Deeohn Ferris    (LE-134P)
Stan Abramson    (LE-132A)
Ken Shiroishi    (EN-342)
John J.  Neylan III   "
Dexter Goldman      "
Phyllis  Flaherty
John Martin
Ralph Turpin        "
Mike Wood

John Mackenzie
Western  Regional Compliance Director

A. Charles Lincoln
Eastern  Regional Compliance Director

Lou's F. Gitto, Director
Air Management Division, Region I

Barbara  Metzger, Director
Environmental Services Division,  Region  II

Stephen  R. Wassersug,  Director
Hazardous Waste Management  Division, Region  III

Winston  A. Smith, Director
Air, Pesticides and Toxics  Management Division,  Region  IV

William  H. Sanders  III, Director
Environmental Services Division,  Region  V

William  B. Hathaway, Director
Air, Pesticides, and Toxics Division, Region  VI

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

Irwin L. Dickstein, Director
Air and  Toxics Division, Region VIII

Harry Seraydarian,  Director
Toxics and Waste Management Division, Region  IX

Gary 0'Neal , Di rector
Air and  Toxics Division, Region X

Regional Pesticides and Toxic Substances Branch  Chiefs

-------
     FIFRA COMPLIANCE MONITORING STRATEGY






                     FOR






              DAMINOZIDE (ALAR)
       OFFICE OF COMPLIANCE MONITORING





  OFFICE OF PESTICIDES AND TOXIC SUBSTANCES





UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

-------
    FIFRA COMPLIANCE MONITORING STRATEGY FOR DAMINOZIDE (ALAR)
REQUIREMENTS
FEDERAL REGISTRATIONS UNDER FIFRA §3
EPA required the Uniroyal  Chemical  Company to:

0   Delete grapes from the ALAR 85 product label (EPA
    Registration Number (Reg. #) 400-79, amended label  accepted
    February 24, 1986).  A new product with a production volume
    limit was registered on January 30, 1986, for use only on
    Concord like grapes (grapes not intended for raisins)  under
    EPA Reg. # 400-430.

0   Amend EPA Reg. # 400-79 to reduce the application rate on
    apples from 8 Ibs/acre to 4 Ibs/acre for spring treatment
    and 3 Ibs/acre for later treatment.  However, the 8 Ibs/acre
    rate was permitted for trees not expected to bear fruit that
    year provided apples produced from the treated trees are not
    harvested (included in February 24, 1986 EPA approval).

0   Amend EPA Reg. # 400-79 to contain an advisory cautioning
    against the use of daminoztde treated apples in apple  sauce
    (advisory accepted by  OPP as part of labeling on 2/24/86).

0   Comply with FIFRA §3(c)(2)(B) data requirements or  have its
    products subject to suspension/cancellation.  Uniroyal  is
    the sole registrant of the active FIFRA §3 registrations
    (see attached data call-in schedule).

EXISTING STOCKS PROVISIONS FOR THE  REGISTRANT AND OTHER PERSONS

Uniroyal 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 product containers bearing
EPA Reg. # 400-79 which are-owned by, controlled by, or in the
custody of Uniroyal  after  February  24, 1986, unless the product
bears  the EPA approved amended label accepted on that date with
grapes deleted  and apple dosages amended.  Noncompl i ance with
this provision  is considered a violation of FIFRA §12(a)(l)(B)  or
§12(a)(l)(E).

Other  persons may legally  distribute, sell, offer for sale, hold
for sale, ship, deliver for shipment, or receive and (having so
received) deliver or offer to deliver product containers bearing
EPA Reg. # 400-79 which conform to  the last label accepted by
EPA (with apples and grapes) prior to the February 24,  1986
amended label until  supplies are exhausted.


*    Butanedioic acid mono 2 ,2-dimethylhydrazide is commonly
called daminozide and also recognized under the trade name ALAR.

-------
                               -2-


IfETuTFTTo^lTDuTfRY
Number of federal  registrants with active daminozide products - 1
(Uniroyal Chemical  Co.)

Number of Producer Establishments - 1 (1984 FIFRA §7 reporting
i nfo rmation)

   EPA Establishment Number 7874-LA-001
   Uniroyal  Chemical Co.
   Geismar,  LA  70734

Number of products affected by this regulatory action - 2

   Product Name       EPA Registration Number

   ALAR 85                 400-79
   ALAR for  Grapes         400-430

NEUTRAL ADMINTSTRATIVE INSPECTION SCHEME

     The Region will negotiate with the  the State of Louisiana
to conduct in FY 87 an establishment inspection for EPA
Registration Number 400-430.  Thereafter, they will conduct  an
establishment inspection every two years for EPA Reg. No. 400-430
until  the production volume limitation is removed from the
registration requirements.   Because Louisiana will  not know  the
production volume  limitation, information obtained  on quantities
produced/distributed is  to  be forwarded  to the Regional office
for review.   EPA will review the FIFRA §7 annual reporting
information  and FIFRA §8 data regarding  movement of pesticides
to assure compliance with this limitation.  If needed for CBI
reasons, EPA inspectors  will conduct establishment  inspections
upon request to verify compliance with this limitation.  OPP
will notify  OCM when the production volume limitation is removed.
OCM will inform Region 6 who will in turn notify the State of the
same information.

     Note: A production  volume limit has been imposed on EPA
Registration Number 400-430 (ALAR 85 for Grapes) as a condition
of registration.  This limitation appears in the FIFRA §3(c)(7)
registration notice for  the product.  Such information is
considered confidential  under FIFRA §7.

     For EPA Reg.  No. 400-79, the Region will  negotiate with the
State of Louisiana to conduct an establishment inspection once
in FY 87 and thereafter  according to the routine pesticide
inspection scheme.
                                        .-
     EPA/State inspectors will conduct use inspections according
to the routine pesticide inspection targetting scheme.

     Tips and complaints will receive highest priority for
i ns pections.

-------
              SUPPLEMENTARY ALAR PRODUCT INFORMATION


0  Number of active FIFRA §3 registrations  for daminozide - 7

   Product Name                    EPA Registration Number

   B-Nine                                  400-069
   ALAR 85                                 400-079
   ALAR a Plant Growth Regulator           400-099
   KYLAR 85 a Plant Growth Regulator       400-103
   B-Nine SP                               400-110
   ALAR Technical                           400-117
   ALAR for Grapes                         400-430

   NOTE:  SAD 85 a Plant Growth Regulator,  EPA Registration
          Number 2749-191 (Aceto Chemical  Co., suspended
          5/18/84)

0  Number of FIFRA §24(c) registrations for daminozide -  1

   ALAR 85 (FIFRA §24(c) SLN Number CA-800035 using EPA
   Registration Number 400-79)

   The FIFRA §24 (c) registration i s> subject to suspension or
   cancellation if the FIFRA §3 registration is suspended or
   cancelled.  The only FIFRA §24(c) registration uses a  FIFRA
   §3 product registered under  Uniroyal.

0  Intrastate Products - 3

   Product Name   EPA Intrastate
                  Registration  Number

   ALAR 85        400-6461
   ALAR 85        400-6466
   KYLAR 85       400-6533

   The intrastate  products are  subject to  denial  if Uniroyal
   fails to comply with the FIFRA §3(c)(2)(B) data requirements.
   Uniroyal  is the sole submitter of the intrastate applications
   for FIFRA §3 registration.

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         UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                     WASHINGTON, D.C. 20460
                            14
MEMORANDUM
                                                       OFFICE OF
                                                PESTICIDES AND TOXIC SUBSTANCES
SUBJECT:
FROM:
TO:
Compliance
Halt Sales
Daminozide
           Strategy for the Agreement to Voluntarily
           of Food-Use Pesticides Containing
John J. Neylan III, Director
Policy and Grants Division           _
Office of Compliance Monitoring (EhK342)

Addressees
     Attached is the Compliance Strategy for the Agreement to
Voluntarily Halt Sales of Food-Use Pesticides Containing
Daminozide signed on June 2, 1989, by Uniroyal, Inc. and EPA.
The strategy sets forth the terms of the agreement, the dates
by which certain activities must be carried out by Uniroyal and
the Agency, and how the Agency Intends to monitor compliance
with the terms of the agreement.  Compliance monitoring will be
directed at Uniroyal to determine compliance with the terms of
the agreement and at distributors and dealers to ensure that
amended labeling has been placed on those products which may be
relabeled.  Growers may be visited in order to determine If
they are aware of the recall and their rights under the recall
and reimbursement program.

     If you have any questions concerning the strategy, please
contact David Stangel of my staff at 382-3477.
Attachment

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                                  ADDRESSEES
ft
 IV
 VI


 VII


 VIM


 IX


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

Barbara Metzger, Director
Environmental Services Division

Stephen R. Wassersug, Director
Hazardous Waste Management Div

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

William H. Sanders  III, Director
Environmental Services Division

William B. Hathaway, Director
Air, Pesticides 4 Toxic Division

William  A. Sprat!In, Director
Air and Toxics Division

Irwin L. Dlcksteln, Director
Air and Toxl'ca Division

David P. Howekamp, Director
Air Management Division

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

Ernest Regna, Chief
Pesticides 4 Toxic Substances Br

Larry Mi Iler, Chief
Toxic 4 Pesticides Branch

Richard DuBose, Chief
Pesticides 4 Toxic Substances Br

PhylI is Reed, Chief
Pesticides 4 Toxic Substances Br

Robert Murphy, Chief
Pesticides 4 Toxic Substances Br

Carl Walters, Acting Chief
Pesticides 4 Toxic Substances Br

Alvin Yorke, Chief
Toxic Substances Branch

Davis Bernstein, Chief
Pesticides 4 Toxics Branch  .

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

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   COMPLIANCE  STRATEGY  FOR  THE  AGREEMENT  TO  VOLUNTARILY  HALT
       SALES OF  FOOD-USE  PESTICIDES  CONTAINING  DAMINOZIDE
                                                        JUN I 4 1989
OVERVIEW
     Daminozide is the active ingredient of Alar, a product
produced by Uniroyal Chemical Company, Inc.  The chemical  is a
plant growth regulator and affects vegetative growth, flower
bud initiation, fruit set and maturity, preharvest fruit drop
and market quality of fruit at harvest and during storage.  The
main use for Alar is on apples.  However, it is also registered
for use on pears, peaches, nectarines, prunes,  sweet and sour
cherries, grapes , brussels sprouts, cantaloupes, tomato
transplants, peanuts and non-food uses.  Uniroyal is the sole
registrant for daminozide and holds 6 registrations.

     Daminozide is under Special  Review by EPA  because certain
oncogenicity studies indicated that the chemical and its
breakdown product UDMH (unsymmetricaI  dimethyIhydrazine) may
pose a carcinogenic risk.

     On June 2, 1989, Uniroyal and EPA entered  into an
agreement whereby Uniroyal agreed in writing to voluntarily
halt sales of food-use products and conduct a recall of all
products down to the user level.   Uniroyal will submit an
application for amended registration of all products.  The
amendment will place a condition  on the registration that  until
there is a final determination on daminozide, Uniroyal  will
sell no daminozide food-use products and will conduct a
voluntary recall of all daminozide products.  EPA will  Issue an
export notification describing the status of daminozide
registrations.  EPA agreed to postpone the Science Advisory
Panel's consideration of the Agency's draft Notice of Intent to
Cancel in July 1989, until the Panel's next meeting in
December, 1989, in part, in order to assess an  interim report
on the studies Uniroyal is conducting.  The agreement is in
effect until a final determination on daminozide has been  made
and any hearings requested have been completed.
REQUIREMENTS OF THE AGREEMENT	

   - On Joi»e 2, 1989, Uniroyal  will  halt all  sales of
     daminozide products bearing food uses.

   - By June 7, 1989, Uniroyal  will  submit an application for
     the amendment of all  daminozide registrations. Uniroyal
     will  amend both its B-Nine daminoz.ide labels to delete the
     tomato transplant use, thereby  making it a non-food use
     product and to relabel all B-Nine stocks in its posse-
     ssion.

-------
                               -2-
     By June 9, 1989,  Uniroyal  will  notify all  dealers and dis-
     tributors of the  recall  and reimbursement  program.

     By June 21,  1989,  EPA will  approve Uniroyal's application
     to amend its B-Nine and  B-Nine  SP labels.

     EPA will issue a  Stop Sale, Use or Removal  Order (SSURO)  to
     Uniroyal, pursuant to the  agreement,  for all  registrations
     with food uses.

     By June 16,  1989,  Uniroyal  will notify all  persons  on their
     grower mailing list of the  recall and reimbursement
     program•

     By July 12,  1989,  Uniroyal  will provide labeling stickers
     for B-Nine and B-Nine SP products to  dealers  and
     distributors.  Uniroyal  will  instruct dealers and
     distributors to relabel  all stocks by August  20, 1989.

     Uniroyal will provide to EPA,  pursuant to  FIFRA §3(c)(2)(B),
     records demonstrating compliance with the  provisions  and
     schedule of  the recall and  reimbursement program.
COMPLIANCE MONITORING	

Inspect ions

   - Compliance monitoring of  this agreement will  be directed
     mainly at Uniroyal  and its efforts to comply  with  the terms
     of the agreement.

   - The Office of  Pesticide Programs (OPP), OCM,  and Region  I
     will  monitor the recall and reimbursement program  and
     Uniroyal's adherence to the terms of  the program.

   - States are to  inspect, within 4 months after  the date this
     strategy Is issued,  any establishment which  produced
     Daminoztde within  the past 3 years.  Followup inspections
     are to be conducted  upon  request.

   - As parrot routine comprehensive Inspections, Regions and
     States^Jshou I d  assure compliance with  the terms of  the
     agreeiwfnt and  monitor .the relabeling  of the  B-Nine products.

   - In those States where Daminozide has  been used in  the past,
     inspections will be  specifically targeted for the  purpose  of
     determining If relabeling of B-Nine products  has occurred.
     These inspections  may also be comprehensive  In nature to
     address compliance with other sections of FIFRA.  The number
     of inspections to  assure  compliance with the  agreement will
     be determined  by the States and Regions.  When lists  of
     Uniroyal distributors and dealers become available,  these
     will  be provided to  the Regions and States.

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                              -3-
   - The Compliance Division of  OCM will  be requesting
     inspections at sites where  the product is being
     consolidated as a result of the recall.   The number  and
     frequency of inspections will  be determined  from
     information the Agency receives related  to the recall.
     Inspections at sites where  Daminozide has been
     consolidated should verify  compliance with FIFRA section
     17(a)(1)  regarding export labeling requirements, storage
     conditions, and FIFRA section  8 records.   Inspectors
     should document the destination and  amount of  exports.
     States are to report this information to  the Regional
     Office.

   - States may conduct inspections of  growers to determine  if
     they are  holding any daminozide products, and  if they  are,
     whether they had been contacted by Uniroyal  and made  aware
     of their  options for recall  and reimbursement  of the
     stocks they are holding.

   - Tips and  complaints will be priority inspections.

CompIi ance

   - The Office of Compliance Monitoring  (OCM) will issue  a
     Stop Sale, Use or Removal Order (SSURO)  to Uniroyal
     pursuant  to the agreement.   The SSURO will allow Uniroyal
     to move stocks of daminozide products only for the
     purposes  of recalling or relabeling  them.

   - After August 20, 1989, Regions and States will issue
     SSURO's for those B-Nine and B-Nine  SP products which  do
     not bear  amended labeling and  take action against those
     distributors selling such misbranded products.  In
     addition, States and Regions will  notify  Region I when
     this occurs so that they may take  appropriate  action
     agaInst UnIroyaI .

   - The name  and address and telephone number of any grower
     who has not been contacted  by  Uniroyal  should  be forwarded
     to Ukfroyal and the Chief,  Compliance Branch,  OCM so  that
     Un(royal  can contact the grower and  OCM  can  followup.

   - When Regions and States encounter  a  distributor or  dealer
     who has continued to sell products rather than participate
     in the recall and reimbursement program,  the Inspector
     should determine the reason why they are  continuing  to
     sell and  the Region will forward this information to  the
     Chief, Compliance Branch, OCM  for  consideration in
     evaluating the effectiveness of the  recall program.

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                              -4-
Reports
   - States are to report within two weeks  of  discovering  any
     violations of the agreement to the Regional  Office.
States are
Daminozide
                to include Information  on  the number  of
                inspections and  violations found  as  part  of
     their quarterly reports to  the Regions.
     Regions are to send information  on  inspections  and
     violations to the Director of  the Compliance  Division
     quarterly.  Violations of  the  agreement should  be reported
     immediately along with supporting documentation.

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             LIST OF UN I ROYAL DAMINOZIDE PRODUCTS
EPA Reg. No.

400-69

400-79

400-99

400-103

400-110

400-117



Intrastates

400-06461

400-06466

400-06533

CA 800035
 Name

B-Nine

Alar 85

Alar

Kylar 85

B-Nine SP

A Iar Techn icaI
- Not affected by the
  Agreement
Alar 85

Alar 85

Kylar 85

California State Registration
Uniroyal  intends to relabel  both B-NIne and B-Nine SP products.

OPP believes that all  the Intrastates are now cancelled.

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 fc
 w
       'o
       5     UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

       /                    WASHINGTON, D.C. 20460

V   "
                      STOP  SALE, USE, OR  REMOVAL ORDER           JUN I  3 1989


 CERTIFIED MAIL                                                         OFF.CF. OF
 RLIURN  RL-CL-lrM  REQUESTED                                      P«T,C,DES ANDTOX.CSU,

 Mr.  James A.  Wylie,  Jr.
 Vice President  and
   General Manager
 Crop Protection Division
 Uniroyal  Chemical  Co.,  Inc.
 74 Amity  Rd.
 Bethany,  CT  06525

 Reference:  DAMINOZIDE - Food Use  Products  Including But Not Limited To
            EPA  Reg.  Nos. 400-69,-79,-99,-103, and -110

      By the authority vested in me  pursuant  to Section 13(a) of the Federal
 Insecticide,  Fungicide, and  Rodenticide  Act  (FIFRA), as amended (7 U.S.C.
 §136k(a)),  and  in accordance with the  enclosed June 2, 1989, "Agreement Between
JJniroyal  Chemical  Company, Inc.,  and the United States Environmental Protection
wency  For Voluntary Halt  of Sales  of  Food-Use Pesticides Containing Daminozide",
hereinafter referred to as the "Agreement",  you are hereby ordered not to
 distribute, sell,  offer for  sale,  hold for sale, ship, deliver for shipment,
 receive and (having  so  received)  deliver or  offer to deliver, remove, or use
 the pesticide(s)  listed above, or any  other  pesticides under your control,
 ownership,  or custody that are subject to  the "Agreement".

      This order pertains to  all quantities of the above-mentioned pesticide(s)
 within  the  control,  ownership, or custody  of your company, wherever located,
 and thus  prohibits the  sale  of daminozide  registered for food uses in the
 United  States by  Uniroyal  and any Uniroyal subregistrant.  The pesticide(s)
 may not be sold,  offered for sale,  held  for  sale, shipped, delivered for ship-
 ment, received  and (having so received)  delivered or offered for delivery,
 removed or used other than in accordance with the provisions of this order o,r
 of further  Stop Sale, Use, of Removal  Orders as may be issued in connection
 with the  pesticide(s).

      Notwithstanding the, provi sions of this  Stop Sale, Use, or Removal  Order,
 you may distribute,  sell,  offer for sale,  hold for sale, ship, deliver for
 shipment, receive  and (having so  received) deliver or offer to deliver, remove,
 or use  the  pesticide(s) affected  by this order which are under your control,
 ownership,  or custody provided it is for purposes of consolidation in one or
 more locations, in order to  implement  a  product recall.  Specifically,  in
 accordance with the  aforementioned  June  2, 1989 "Agreement", Uniroyal will
 recall  from all  distributors, dealers  and  subregistrants all stocks and
^nventories of  daminozide  products  registered for food uses, including stocks
Returned  by growers.

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                                   - 2 -
     In addition, the information cited on page  5,  paragraph 4,  Review of  Records,
of the "Agreement" must be reported in writing to the EPA  Representative listed
below beginning on July 1, 1989 and quarterly thereafter until  such  time as
Uniroyal  has demonstrated to the Agency that the recall  has  been completed or
the "Agreement" terminates as stated on page 8,  paragraph  8, Duration  of Agreement.


EPA Representative:  Ms. Sherell A. Sterling (EN-342)
                     U.S. Environmental Protection  Agency
                     Office of Compliance Monitoring
                     401 M Street,  S.W.
                     Washington, DC  20460
                     Phone # 382-7835


     Any  person violating the terms or provisions of this  order shall  be
subject to the civil  or criminal penalties prescribed in Section 14  of the
Act (7 U.S.C.§1361).
                                        Michael  F.  Wood,  Director
                                        Compliance  Division (EN-342)
Enclosure

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        AGREEMfiTTt1 BETWEEN UNIROYAL CHEMICAL COMPANY,  INC.
                      AND THE UNITED STATES
                 ENVIRONMENTAL PROTECTION AGENCY
                  FOR VOLUNTARY HALT OF SALES OF
            FOOD-USE PESTICIDES CONTAINING DAMINOZIDE
      WHEREAS, on May 12, 1989, the U.S. Environmental Protection
          ^
Agency ("EPA") issued a Notice announcing the Agency's

preliminary determination pursuant to the Federal Insecticide,

Fungicide and .Rodenticide Act  ("FIFRA") to cancel all food-use

registrations for daroinozide, and indicating that a draft Notice

of Intent to Cancel had been forwarded with appropriate

supporting documents to the FIFRA Scientific Advisory Panel
                                                              JM.
("SAP") for its review; and


      WHEREAS, following the SAP's review and the evaluation  of

comments on the Notice of Intent to Cancel by the U.S. Department

of Agriculture and public comments, the Agency will issue a Final

Determination whether the registration should be cancelled; and


      WHEREAS, the SAP Ls tentatively scheduled to review such

matters at its July, 1989 meeting; and


      WHEREAS, the SAP is to consider at such meeting, among

other materials* interim results of a two-year drinking water

oncogenicity study of the daminozide metabolite UDMH on mice  and

rats which EPA required Uniroyal Chemical Company, Inc.

( "Uniroyal"f "to perform "pursuant to a FIFRA § 3(c)(2)(B) Data

Call-in Notice issued in 1986  the final report of which is due in

September, 1989, and interim results of an additional

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                              - 2 -
oncogenicity study on mice which EPA required Uniroyal to perform


on March, 1.987, the final report on which is due in January,


1990; and



      WHEREFORE, in order to allay public confusion and concern


regarding the safety of daminozide food-use products and the


consumption of apples and other foodstuffs caused by publicity


related to daminozide and this regulatory action,. Uniroyal hereby


voluntarily agrees, on the terms described below,- to halt the


sale of food-use pesticides containing daminozide, and to treat


such food-use registrations as "suspended" within the meaning of


FIFRA § 12(a)(l)(A), pending the full review of the matter by the
                                                               x-

SAP and the completion of the Agency's Special Review process,


including any FIFRA § 6 cancellation hearing.



                        Terms  of Agreement



      1.   Immediate Halt to Sales.  Uniroyal agrees voluntarily


to halt all sales of all its products containing daminozide for


all food uses.  In order to implement this Agreement, Uniroyal


and EPA agree that all food-use registrations of pesticides


containing daminozide shall be treated as "suspended" for


purposes of FIFRA S 12(a)(l)(A).  To accomplish this, Uniroyal


will submit,-within five-days of the execution of this Agreement,


an application for an amendment to all such registrations.  The


amendment will place a condition on the registrations requiring

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                              - 3 -
that from the date on which the application is granted until the
date on which EPA issues a Notice of Final Determination of
Intent to Cancel the Daminozide Registrations, or the termination
of any FIFRA § 6 cancellation hearing challenging such action,
whichever occurs later: (1) no daminozide food-use products will
be sold by Uniroyal for use in the United States; and
(2) Uniroyal will conduct a voluntary recall, as described in
paragraph 2 below, of all such daminozide products.  Simultaneous
to its issuance of the amended .conditional registration, EPA will
issue a "Stop-Sale, Use or Removal" Order to Uniroyal regarding
all food-use registrations of daminozide, and Uniroyal agrees not
to challenge the validity of such "Stop Sale, Use or Removal" "
Order.

      It is the understanding of EPA and Uniroyal that the above
measures will prohibit the sale of daminozide registered for food
uses in the United States by Uniroyal and any Uniroyal
subregistrants.
      2.   Voluntary Product Recall.  Uniroyal voluntarily wi^
recall from all""distributors, dealers and subregistrants all
stocks and inventories of daminozide products registered for food
uses, including stocks returned by growers.   (See paragraph 5.)
Uniroyal specifically agrees as part of its voluntary recall
effort to notify by letter, to be mailed within one week of the
execution of this Agreement, all distributors and dealers known

-------
by Uniroyal to be direct Unir*byal damlnozide customers, and any
subregistrants .•  Uniroyal agrees in such letters to indicate that
Uniroyal has agreed voluntarily to halt all food-use sales of
daminozide," and to recall all outstanding stocks and inventories
from any source through distributors and dealers and to reimburse
the owners of such products at the invoice price or, if no
invoice is available, the prevailing price at time of purchase.
In addition, Uniroyal agrees to mail to all persons on its grower
mailing list (to be provided to EPA pursuant to paragraph 4
below), within two weeks of the execution of this Agreement,  —•
letters indicating that Uniroyal has agreed voluntarily to halt
all food-use sales of daminozide, and that Uniroyal has agreed^
voluntarily to recall all outstanding stocks and inventories from
any source through distributors and dealers and to reimburse the
owners of such products at the invoice price or, if no invoice is
available, the prevailing price at the time of purchase.      .
Uniroyal agrees to allow EPA to review and approve the text of
these letters prior to their release.  Uniroyal also agrees as
part of such recall to pay all reasonable costs of transporting
the stocks and Inventories to a site or sites, to be designated_
later, where the product will be repackaged and/or relabeled for
subsequent sale (or storage for subsequent sale) for non-food
uses, or for export as otherwise permitted by law.  Uniroyal
agrees to implement the recall and reimbursement program
described in this Agreement as expeditiously as possible.

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                              - 5 -
      3.   Amendment of Uniro'yal's "B-Nine" Label.  In
conjunction with the provisions of paragraph 2 above, Uniroyai
agrees to amend its B-Nine daminozide label, which is primarily a
non-food-use product, to delete the tomato transplant use from
the label, and to relabel (with a sticker or other means) any
B-Nine stocks in Uniroyai's possession to delete the tomato
transplant use.  With respect to any stocks or inventories in the
possession of distributors or dealers, Uniroyai agrees to issue
to such distributors and dealers within three weeks of EPA's
approval of the amendment appropriate labeling stickers for the
deletion of the tomato transplant use, and agrees to inform the
distributors and dealers that such labels should be affixed to
                                                              *•
all B-Nine products within the channels of trade no later than 60
days after EPA's approval of the amendment.  EPA agrees that it
will act promptly on Uniroyai's application to so amend the
registration, and in any event to grant permission to delete the
use no less than three business days from EPA's receipt of
Uniroyai's application.

      4.   Review of Records.  In recognition of the needs and
benefits of EPA's ability to monitor progress of Uniroyai's
voluntary recall efforts, Uniroyai agrees that, for purposes of
this matter, the following are "data" within the meaning of FIFRA
§ 3(c)(2)(B) and are subject to call-in by EPA pursuant to that-
provision:  records demonstrating daminozide sales by Uniroyai

-------
                              - 6 -
directly to distributors, dealers and subregistrants in  1988 and
1989, including'such records as necessary to determine the
identity of all purchases and the amounts purchased; records
demonstrating compliance with the provisions and schedule of the
recall and reimbursement program, including details of the recall
of such products from all direct Uniroyal customers (which may
include distributors, dealers and subregistrants) and such
records as necessary to determine the identity of all parties
returning daminozide products to Uniroyal and the amounts
returned; records indicating the amounts of daminozide product's
relabeled as B-Nine; and records regardi/v.y all sales of  B-Nine
products, including quarterly reports of current and future
B-Nine sales, records demonstrating historical sales for B-Nine
products and the approximate levels of B-Nine stocks and
inventories presently available in the distribution chain in
June, - 1-989, as well as such prospective records as necessary to
demonstrate the identities of all Uniroyal direct cu  :omers
purchasing B-Nine and the amounts purchased.  The quarterly
reports are being provided to allow EPA to monitor B-Nine sales
in order to ensure that persons not a party to this Agreement do
not divert B-Nine unlawfully to food use.
      Uniroya-i further agrees that all records indicating
satisfaction of the recall requirements under this Agreement

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                              - 7 -
shall be considered "reports" within the meaning of FIFRA
§ 12(a)(2)(N).

      5.   Us.er. Notification.  In addition to the notification
described in paragraph 2 above, Uniroyal agrees within two weeks
of the execution of this Agreement, to send to the organizations
listed below a letter, for distribution to their members,
indicating that Uniroyal has agreed with EPA voluntarily to halt
all food-use sales of daminozide and to recall all outstanding
stocks and inventories from any source through distributors and
dealers and to reimburse the owners of such products at the
invoice price or, if no invoice is available, the prevailing
price at the time of purchase.  The letters will explain the
reasons for this action and urge the growers to cease using the
product immediately.

      The associations to which Uniroyal agrees to send this
letter will include at least the following:  (1) International
Apple Institute; (2) New York - New England Apple Institute;
(3)  Processed Apple Institute; (4) National Food Processors •
Association; (5T Washington State Apple Commission; and (6) the
National Peanut Council.  In addition, Uniroyal agrees to send
the. same or a similar letter to the lead land grant university in
each major apple-growing state within the same two-rweek period.	
Uniroyal agrees to allow EPA to review and approve the text of

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                              - 8 -
                           *
the letters required by this paragraph or to use the same letter


described in paragraph 2.




      6.   ^Export Notification.  EPA will issue an export


notification regarding the status of daminozide registrations.


The export notifications will explain that Uniroyal has agreed


voluntarily to halt sales, and that in order to implement this


Agreement, EPA and Uniroyal have agreed to treat -the food-use


registrations as "suspended" for enforcement purposes.  EPA


agrees to provide Uniroyal by telecopy with the text of such


notifications, after they have been finalized and cleared for


issuance, but five days prior to their issuance, in order that
                                                              s~

Uniroyal may notify affected customers.  This is expressly


understood not to imply a right to edit or change the text of


such notifications, which will be drafted independently by the


Agency.




      7.   SAP Review.  EPA agrees to postpone the SAP's


consideration of the Agency's Draft Notice of Intent to Cancel


until the SAP's December, 1989 meeting.  EPA further agrees to


suspend the "five-minute rule" which ordinarily limits to five


minutes a registrant's opportunity to make oral presentations to


the SAP.  Instead, both EPA and Uniroyal shall receive thirty


minutes to make oral presentations, as supplemented by written


materials, with the further understanding that the decision to


extend the period for oral presentations is in the sole

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                               -  9  -
 discretion of  the  SAP.   In  addition,  the  Agency agrees  to  reserve
 at least  one  full  day for the  SAP's  consideration  of  daminozide.

       8.    Duration of  Agreement.  This Agreement  shall  not
 expire and will  remain  enforceable until  the  completion  of the
 SAP review and EPA's issuance  of  a Final  Notice of Determination
 to Cancel the  Daminozide Registrations, and any FIFRA §  6
 cancellation  hearing initiated as a  challenge thereto,  or  a
 decision  by the  Agency  upon its review of the SAP  comments to
 withdraw  its  Draft Notice of Intent  to Cancel,  except that    _
 Uniroyal  and  EPA hereby agree  that either party can request
 reconsideration  of this matter upon  the completion of the  SAP  ,
 review and as  a  result  of any  such reconsideration may  mutually
 agree  to  terminate the  Agreement  earlier.  EPA and Uniroyal
 anticipate that  the SAP review and the decision whether to issue
 a  Final Notice of  Determination to Cancel or  to withdraw the
 Draft  Notice of  Intent  to Cancel  will be  accomplished by the
 Agency no later  than March,  1990, and that any FIFRA §  6
 cancellation  hearing initiated by Uniroyal as a challenge  thereto
 will be completed  by September, 1991,  and that the Agency will
 use its best efforts to accomplish these  goals within the  spirit
 and intent of  this Agreement.

~      9"."    Limited Purpose  of  Agreement.   Uniroyal by this
 Agreement does not admit or concede  that  daminozide or  its
 metabolities  present a  significant risk of cancer, or an

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                              -  10  -
                             *

unreasonable adverse risk to health or the environment within the
meaning of FIFRA § 3(c)(5), or that any tolerances for daminozide
established" under the Federal Food, Drug and Cosmetic Act are
inappropriate or should be reduced or revoked.

      EPA by this Agreement does not modify or in any way recant
its preliminary determinations concerning daminozide or its
metabolities as expressed in the Preliminary Determination to
Cancel Certain Daminozide Product Registrations published at
54 Fed. Reg. 22,558 (May 24, 1989).  In, addition, EPA
specifically reserves the right to take any appropriate action
under the Federal Food, Drug and Cosmetic Act.

      10.  Change in Circumstances.  Uniroyal agrees that nothing
in this Agreement limits EPA's authority to take appropriate
regulatory action against daminozide or its metabolites under any
of its statutory or regulatory authority if, in EPA's judgment,
changed circumstances or new information indicate that such
additional measures are necessary.   EPA agrees that nothing in
this Agreement limits the rights of Uniroyal to challenge such
additional actions.

      11..- Enforceability.  Uniroyal acknowledges the
enforceability of this Agreement pursuant to FIFRA §§ 3(c)(2)(B),
12(a)(l)(A), 12(a)(l)(I) and 12(a)(2)(N), and agrees that it will

-------
                            .  -  11  -
                            *


not challenge or encourage or assist any party to challenge the

validity of this Agreement in any forum.
James A.  Wylie, Jr,
vice President and
  General, Manager
Crop Protection Division
Uniroyal  Chemical Co., Inc
Victor J/yKimm
Acting Assistant Administrator
  for Pesticides & Toxic
  Substances
United States Environmental
  Protection Agency
       (Date)
                                                    2,
               (Date)

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              UW I CL-» 3 J M I C.3 C.NVlKVJINIVItlN I ML. t'HU I tC I lOlN

                               WASHINGTON. O.C.  20460
                                   NQV   7  879
                                                              OFFICE OF ENFORCEMENT
  MEMORANDUM

  SUBJECT:  CBCP Suspension Order Enforcement Strategy

  TO:       Enforcement Division Directors
            Pesticides Branch Chiefs

Background

       On September ^f-d^77/-^e-Administrator--announced'his--«tent-ion-to--take ••••-
  two separate suspension actions with respect to pesticide products containing
  dibromochloropropane (DBCP).  These actions were taken pursuant to his autho-
  rity under Section 6(c) of the Federal Insecticide, Fungicide  and Rodenticide
  Act, as amended (FIFRA).  On October 21, 1977, because no registrants invoked
  their right to a hearing pursuant to Section 6(c)(2), the Administrator
  issued a Suspension Order concerning DBCP products.  The order was based on
  the findings that DBCP is carcinogenic and also found to damage human repro-
  ductive functions and may cause sterility in males.  The October 27,  1977,
  Suspension Order therefore proposed two separate actions: (1)  the
  "Unconditional" or "Specific Food Use" Suspension of all products registered
  for use on nineteen (19) specific food crops in which DBCP  residues-occurredy-
  or appeared likely to occur in the edible portion of the treated crop; and
  (2) A "Conditional" Suspension of DBCP products registered  for all other end
  uses.  The conditionally suspended uses were:  cotton, soybeans, citrus, grapes,
  pineapples, peaches, nectarines, plums, almonds, commercial okra, commercial
  lira beans, commercial snap beans, commercial southern peas, berries  (black-
  berries, blueberries, loganberries, dewberries, boysenberries, raspberries),
  strawberry nursery stock, apricots, cherries, figs, walnuts, bananas, turf
  (commercial and residential) and ornamentals (commercial and residential).   For
  the conditionally registered uses it was thought that risks to applicators
  could be sufficiently reduced on an interim basis by placing restrictions on
  the product, such as, limiting use to certified applicators using respirators
  and protective clothing.

       On July 18, 1979, the Administrator announced his intention to suspend
  all remaining uses of pesticide products containing dibromochloropropane
  (DBCP).  This Notice of Intent to Suspend is based on additional information
  showing that the conditional suspension is not adequate to  reduce the risks
  associated with continued use of DBCP, and in turn prevent  an  imminent hazard
  during the time required to complete full scale cancellation proceedings which
  are now pending pursuant to Section 6(b) of FIFRA.  The new findings  reveal
  that DBCP residues may occur even in crops which are not grown in contact with
  or in close proximity to treated soil; that treatment with  DBCP may result  in
  contamination of water supplies, including drinking water sources; and that
  application of DBCP may result in ambient air levels of DBCP at sites outside
  the application area and may result in ambient air levels of DBCP at  the site
  of application several days after application.

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                                -2-
    Pursuant to Section 6(c)(2) of ETFRA, each  registrant of a DBCP product
was given the opportunity to request an expedited  hearing on the question
of vhether an imminent hazard existed.  Three registrants requested such a
hearing and following these proceedings the Administrative Law Judge presiding
on the issuef ruled that an imminent hazard did in fact exist and recommended
to the Administrator that all remaining uses of pesticide products containing
dibromochloropropane be suspended.

     On October 29, 1979, the Administrator issued a Suspension Order suspend-
ing all products containing dibromochloropropane with  the exception of those
products bearing directions for use on pineapples.   This usage was strictly
limited to the State of Hawaii.

     A copy of the Notice of Intent to Suspend, the Recommended Decision by
Administrative Law Judge, Gerald Harwood, the Suspension Order, a copy of
the recall letters sent to registrants of DBCP  products, and a list of reg-
istrants and registered DBCP products are enclosed.

     This memorandum represents EPA's Enforcement  Strategy to be used in
relation to this Suspension Action.

Enforcement Policy                                   	. .    ...  ..

     The Agency intends to ensure that the Administrator's Order is strictly
complied with by all affected persons, including manufacturers, foemulators,
registrants, wholesalers,,.retailers and..users,..-	,

         On November 5, 1979, the Pesticides and Toxic Substances Enforce-
         ment Division notified by certified mail  all  registrants and/or
         producers of products containing DBCP  requesting that they:

            a. remove from sale down to and including  the retail level
               all existing stocks of products  bearing suspended uses;

            b. recall those products which do not  bear  directions for use
               on pineapple;

            c. relabel with interim or amended  labeling those products
               bearing directions for use on pineapple.

         The interim labeling we proposed would bear the statement "For
         Sale for Use on Pineapples in Hawaii Only".  No product may
         be legally shipped after March 1, 1980, without approved amended
         labeling.  Those products in the state of  Hawaii bearing directions
         for use on pineapples shall be removed from sale until they have
         been relabeled with interim or approved amended labeling.  Under
         no circumstances shall relabeled products  be  sold at the retail
         level in any state other than Hawaii.

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                                -3-
ElRrcement Procedures

     1.  After initial contact with  the  registrant,  an inspector from the
   ~    Regional Office or State  should visit affected registrants to
         discnan the recall action and monitor the steps taken to comply
         with the recall.  Proper  storage of recalled products should
         be stressed.  See Section 14 of the Pesticides Inspection Manual
         for information on procedures to be followed in monitoring the
         reran.

     2.  If a firm refuses to recall its products, the Regional Office in
         cooperation with the States shall issue Stop Sale, Use or Removal
         Orders and/or seizures  to effect removal of the products from the
         channels of trade.

     3.  When necessary the Regional Offices and States will take
         appropriate enforcement action  against those persons found
         in violation of the DBCP  Suspension Order.

     Regional Offices shall request  States to identify and recall products
bearing intrastate labels since  intrastate products  represent a major share
of those registrations which are currently active.  The Regions should also
inform the States that only products bearing federal registrations were
     recall letters by PTSED.  Those Hawaiian intrastate products bearing
           for use on pineapples may be  relabeled if the state so wishes.
Use of Existing Stocks and Disposal                   .  ___    . ...... ______

     As stated in the Administrator's  Suspension Order,  the use of existing
stocks of DBCP (except those products  bearing directions for use on pineapples
in Hawaii) is prohibited and would be  in  violation of the Suspension Order and
subject to enforceaient action.  Persons desiring to dispose of stocks of DBCP
products should be apprised that  they  may arrange with the appropriate regions
to ship their products for disposal.   This may include returning the product
to the supplier, or disposal in accordance with directions provided by the
Office of Solid Waste.  Disposal  questions may be referred to Mr. Ray Krueger
(202-472-9403).

Export '

     DBCP products may be exported.  Exportation must be in accordance with
FIFRA Section 17 (a) which includes a requirement that the product must      .  /
bear specific labeling.  Registrants exporting DBCP products affected "
by the Suspension Order should also be cautioned in relation to the
stipulation signed by the Department of State concerning the utilization
of U.S. funds for O.S. AID regulation  entitled "Pest Management Program,
Interim Pesticides Procedures" , published in  the Federal Register on
January 7f 1976.  The notice states that  AID  will not provide assistance
    the procurement or use of a pesticide which has been finally suspended
   'cancelled by EPA.

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 Indemnification
      The Office of Enforcement has been advised by the Office of* General Counsel
 that registrants of DBCP products would not be eligible to make any claim for
 an  indeminity payment until the registration of their pesticide is canceled,
 (See section 15(a) of FIFRA).   Any questions concerning indemnities should '
 be  directed  to Mr. Mitchell Bernstein, Office of General Counsel (202-426-9448).
 Inquiries
    .  Should  you have any questions concerning any facet of this memorandum and
J±e- DBCP Suspension.£rder,-pleas^^
                                       A.  E.  Conroy EC,
                                    Pesticides and Toxic substances
                                          Enforcement Division
Enclosures

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             UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                         WASHINGTON, D.C. 20460
                           OCT  7
       OFFICE OF
PKSTICIUES AND TOXIC SUBSTANCES
MEMORANDUM

SUBJECT:  Compliance Strategy for the
          Emergency Suspension of Dinoseb

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

TO:       Addressees
     On October 7, 1986, the Administrator of the Environmental
Protection Agency (EPA) sighed an Emergency Suspension Order
immediately suspending the registrations of pesticide products
containing dinoseb or any of its four salts.  This Emergency
Suspension Order prohibits the continued sale, distribution and
use of all dinoseb products after October 7, 1986.  On the same
day, the Administrator signed a Notice o* Intent to Cancel and
Notice of Intent to Deny the registrations of all dinoseb products

     Attached is the Final Compliance Strategy for the Emergency
Suspension and Cancellation of Dinoseb.  Please transmit a copy
of this Strategy 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 Dan Helfgott (EN-342, FTS 382-7847) of my
staff.

     Thank you for your cooperation.
Attachment

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                            ADDRESSEES
II
IV


V


VI
Douglas D. Campt (TS-766C)
Victor Kimm      (TS-788)
Jim Lamb         (TS-788)
Terrell Hunt     (LE-134A)
Stanley Abramson (LE-132A)
John Seitz  :.  ,   (EN-342)
Ken Shiroishi
Phyl1i s Flaherty
John Martin
John J. Neylan III
Ralph  Turpin
Mike Wood
Dexter Goldman      "

Jake Mackenzie
Western Regional  Compliance Director

A. Charles Lincoln
Eastern Regional  Compliance Director

Louis  F. Gitto, Director
Air Management Division

Barbara Metzger, Director
Environmental  Services Div.

Stephen R. Wassersug, Director
Hazardous Waste Management Div.

Winston A. Smith, Director
Air, Pest. & Toxic Mgmt Div.

William H. Sanders III, Director
Environmental  Services Div.

William B. Hathaway, Director
Air, Pesticides & Toxics Div.
VII  William A.  Spratlin, Director
     Air & Toxics Division

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

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

X    Gary 0'Neal , Di rector
     Ai r & Toxi c Division
Gerald M. Levy, Chief
Office of Pesticides & Toxic Sub

Ernest Regna, Chief
Pesticides & Toxics Sub.  Branch

Larry Miller, Chief
Toxic & Pesticides Branch

H. Kirk Lucius, Chief
Pesticides & Toxic Subs.  Branch

Phyllis Reed, Chief
Pesticides & Toxic Subs.  Branch
Norman E. Dyer, Chief
Pesticides 4 Toxics Subs. Branch

Leo Alderman, Chief
Toxics & Pesticides Branch

Alvi n Yorke , Chief
Toxic Substances Branch

Richard Vaille, Chief
Pesticides & Toxics Branch

Anita Frankel , Chief
Pesticides & Toxic Subs. Branch
     Sue Vogt       (TS-788)
     Deeohn Ferris  (LE-134P)

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                  COMPLIANCE STRATEGY FOR THE
       T 1985     EMERGENCY SUSPENSION OF DINOSEB
OVERVIEW
     On October 7, 1986, -the Administrator of the Environmental
Protection Agency (EPA) signed an Emergency Suspension Order
immediately suspending the registrations of pesticide products
containing dinoseb (2 sec-butyl-4,6-dinitrophenol ) or any of
its four salts.  This Emergency Suspension Order prohibits the
continued sale, distribution and use of all dinoseb products
after October 7, 1986.  At the same time, the Agency also
issued a Notice of Intent to Cancel and Notice of Intent to
Deny all registrations of pesticide products containing dinoseb.
These actions are also applicable to intrastate products for
which an application for federal registration has been submitted
and FIFRA §24(c) Special Local Needs Registrations.

     Both of the October 7, 1986 regulatory actions are based
on data which shows that dinoseb exposure causes developmental
toxicity (including frank teratogenic effects), reproductive
toxicity, acute toxicity, cataractogenic potential, immunotoxicity
and oncogenicity (from parent compound  and nitrosamine contaminants).
The developmental toxicity effects are  the largest concern since
data indicate an immediate risk potential for fetuses of pregnant
women exposed to dinoseb.

     The Agency and States will  assure  compliance with the
Emergency Suspension Order and Cancellation Order by issuing
and monitoring Stop Sale, Use or Removal Orders (SSURO) and
Formal Recall requests, conducting inspections at the producer,
retail and user levels as well as investigating tips and complaints.
The inspections are to assure that suspended or cancelled
products are not being used or moved in commerce.

REQUIREMENTS

     The October 7, 1986 Emergency Suspension Order states that,
effective immediately, no person in any State may distribute,
sell, offer for sale, hold for sale, ship, deliver for shipment,
or receive and (having so received) deliver, offer to deliver,
or use all dinoseb products.

     The Emergency Suspension of dinoseb products is effective
immediately regardless of whether or not the registrant requests
an expedited hearing.  The Order will remain in effect until
completion of the hearing and issuance  of a final order on the
i 3sue of suspension .

     If the Agency does not receive a timely and valid request
for a hearing concerning the Agency's determination that an
imminent hazard exists, the suspension  of a dinoseb product
will become final by operation of law,  will not be reviewable
by any court, and will remain in effect until a final order is
issued concerning the proposed cancellation of that product.

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                              -2-
     The Agency also issued on October 7, 1986, a Notice of
 Intent to Cancel the registrations of all pesticide products
containing dinoseb.  The Notice allowed affected registrants
 30 days to request a hearing on the proposed cancellation or
 have their dinoseb product cancelled.  Submission of a request
 for an expedited hearing concerning the emergency suspension
 of a particular dinoseb product will not prevent cancellation
 of that product in the event no cancellation hearing is requested
 by the registrant.

 Regulated Industry
     The Emergency Suspension Order affects all pesticide products
containing dinoseb or any of its four salts, including those in
the possession of registrants, distributors, and users.  There
are 64 registrants located in 25 States, including one importer.
There are 181 products (100 federally registered products, 81
intra-state products), made from 6 formulations of dinoseb.
Current FIFRA and TSCA Enforcement System (FATES) data indicate
there are 15 establishments which produced a pesticide product
containing dinoseb in 1985.  Appendix I contains a list of
registrants and producers.  Appendix II contains a list of
producer establishments.

     Dinoseb (including the four salts of dinoseb: al kanol ami ne,
triethanolamine , ammonium and sodium) is registered as a herbicide,
desiccant, fungicide, and insecticide.  The principal use is
to control broadleaf weeds as a contact herbicide at preemergence
and postemergence.

     The major use sites by volume include: soybeans (40 percent),
cotton (15 percent), potatoes (16 percent), peanuts (2 percent),
alfalfa (4 percent), snap beans (2 percent), peas (2 percent),
grapes (2 percent), and almonds (1 percent).  Other use sites
include: forage legumes, small grains, fruit and nut orchards,
berries, cucurbits, hops, onions, garlic, ornamentals, conifers,
and noncrops (such as rights-of-way and aquatic drainage ditches).

     The common trade names of dinoseb are: DNBP, ONOSBP, "dinitro",
dinoseb (F-ISO),  Caldon, Sinox, Vertac General  and Selective
Weed Killer, Basanite, Chemox General and PE, Chemsect, Dinitrex,
Dinitro-3, Dinitro General, Drexel Dynamite 3,  Dynamite,
Elgetol  318, Gebutox, Hel-Fire, Kiloseb, Nitropone C, Subitex,
Unicrop DNBP, Vertac Dinitro Weed Killer 5, Dynanap, Premerge Plus
with Dinitro, and Klean Krop.
WTRTTTCir
     The Office of Pesticide Programs will contact affected
groups as outlined in the attached Communication Strategy.

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                              -3-
COMPL IANCE' "MON ffOR ING"
     The Agency sent each registrant a package, by certified
mail, containing the Emergency Suspension Order, Notice of
Intent to Cancel, SSURO, and a Formal  Recall letter.  The Formal
Recall letter requested the registrants to determine the locations
of affected products and amount at each location, effect the
return of the recalled products to their company and inform
the Agency of their inventory of all dinoseb products.  In the
event that the certified mailing is returned to the Agency
and subsequent attempts to deliver the package are unsuccessful,
OCM will  ask the Regions to locate the registrant and deliver
the package.

Neutral Administrative Inspection Scheme (NAIS)	
     Regions/States will  conduct inspections of registrants
and producer establishments within 30 days of the suspension
action.  Producer establishment inspections (PEI's)  are conducted
to assure that producers  and registrants are not using, distributing,
selling, offering for sale, holding for sale, shipping, delivering
for shipment, or receiving and (having so received), delivering
or offering to deliver, to any person suspended or cancelled
dinoseb products.  During PEI's, inspectors are to collect
information from the producers on the names and addresses  of
all consignees of their product within the last 18 months,
if this information has not already been obtained as part  of
the response to the Recall.  Information on the names and
locations of dinoseb dealers may also be obtained by contacting
the registrant's main business office.  Regions should provide
States with a list of dealers based on the information obtained
through the response to the Formal  Recalls and the PEI's.

     Regions/States will  also conduct dealer and user inspections
in order to determine compliance with the emergency  suspension
order, cancellation order, and SSURO's.  Assuring geographic
distribution, Regions/States are to randomly inspect 10 percent
of the dealers.  These inspections should be completed within
90 days of the suspension.  States should issue SSURO's under
State authority, or have  Regions issue SSURO's, to dealers
found holding or selling  suspended products as well  as taking
enforcement actions as appropriate.

     Users of dinoseb may be identified through the  major  uses
of dinoseb as outlined in the Regulated Industry section of
this Strategy.  Inspectors should examine records of sale,  if
they are available, in order to further identify users.  Regions/
States will conduct use inspections based on this information.

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                              -4-
     Regions/States should respond to all tips and complaints
regarding possible violations of the dinoseb suspension/cancell-
ation order as soon as possible.

     Regions will follow-up and track the Formal  Recall following
the procedures outlined in section 14 of the Pesticides Inspection
Manual .
Office of Pesticide Programs/Registration Division (OPP/RD)   "

0 Will mail  copies of the Emergency Suspension Order and
  Notice of Intent to Cancel  to trade associations, and other
  Federal and State Agencies.

0 Will maintain a list of registrants affected by the Emergency
  Suspension Order and provide this information to OCM.

0 Will send copies of certified mail  receipts, or a list of
  the dates they were received by the registrants, to OCM and OGC.

0 Will contact OCM regarding  undel i verabl e or missing certified
  mail receipts within 15 working days from the date of the mailing

Office of Compliance Monitoring (OCM)	

0 Will prepare Stop Sale, Use or Removal  Orders (SSURO).

0 Will prepare Formal Recall  letters.

0 Will send by certified mail a package to each affected registrant
  containi ng :

      1) A  copy of the Emergency Suspension Order.

      2) A  copy of the Notice of Intent to Cancel.

      3) A  SSURO for the products covered by the October 7, 1986
         Emergency Suspension Order.

      4) A  Formal  Recall letter.

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                               -5-
0 Will prepare and transmit the Compliance Monitoring  Strategy
  to the Regions.

0 Will notify the Regions regarding undeliverable or missing
  certified mail  receipts.

0 Will provide a list of all registrants and  user groups  affected
  by the Emergency Suspension Order, those persons issued
  SSUROs, those registrants with cancelled dinoseb products,
  and additional  pertinent  information to  the Regions.

0 Will keep the Assistant Administrator of OPTS informed  on
  the status of the Formal  Recall, inspections, and enforcement
  actions for one year.  These reports will  be based on monthly
  status reports  from the Regions for the  first three  months,
  and quarterly reports for the next three quarters.

Regions              		
0 Will  provide to OCM the name of a Regional  Contact  person.

0 Will  coordinate with States in the implementation  of this
  Strategy.

0 Will  provide a list of producer establishments of  dinoseb
  products to the States.

0 Will  provide States with copies of materials  received from  OCM.

0 Will  conduct inspections in States without  Cooperative
  Enforcement Agreements.

0 Will  issue SSURO's for any suspended  stocks found.

0 Will  take enforcement action as appropriate.

0 Will  follow-up and track the Formal  Recall.

0 Will  report to OCM for one year on the status  of the Formal
  Recall, the number and type of inspections, and the number
  and type of violations found by the Regions/States.  This
  reporting will be monthly for the first three  months and
  quarterly for the remaining three quarters.

0 Will  attempt to deliver the Emergency Suspension Order to
  those registrants that Headquarters was unable to  notify  by
  certi f i ed ma il .

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                              -6-
0 Will  conduct inspections.

0 Will  issue SSURO's under State authority,  or have  Regions
  issue SSURO's,  for any  suspended  or  cancelled  stocks  found.

0 Will  take enforcement action,  as  appropriate,  provided  they
  have  the authority.

0 Will  report to  the Regions  on  actions  taken  under  the
  emergency suspension.

0 Will  report to  the Regions  for one year on the number  and
  type  of inspections  and violations found  by  the State.   This
  reporting will  be monthly  for  the first three  months  and
  quarterly for the remaining three quarters.

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                           APPENDIX 1


                DINOSEB REGISTRANTS AND PRODUCTS

                          REGION I (2)


Staples C W Inc.'
PO Box 328
Presque Isle, Me  04769
EPA Reg. No: 1345-004

Uni royal Chemi cal
Division of Uni royal, Inc.
74 Amity Rd.
Bethany, Ct  06525
EPA Reg. No: 400-075 ,-100 ,-138 ,-139,-140,-147,-153,-158,-174,-190,-235,
-302,-327


                         REGION II (6)


Agway, Inc.-Crop Services
Chemical Division
PO Box 4741
Syracuse, NY  13221
EPA Reg. No: 8590-026

American Hoechst Corporation
Rt. 202-206 N.
Summerville, NJ  08879
EPA Reg. No: 8340-010

Blue Spruce Company
50DivisionAvenue
Millington, NJ   07946
EPA Reg. No: 1439-175 ,-190,-231,-235

N.Y.S. College  of  Agriculture and Life Science
Cornell University
Attn.-Dr. Dewey
Ithaca, NY  14853
EPA Intrastate  Accession No: 38655-10431

Trans Chemical  Industries, Inc.
150 Meadowlands Parkway
Secaucus, NJ  07094
EPA Reg. No: 9618-013

White House Company
8 Kingstand Ave.
Harrison, NJ  07027
EPA Reg. No: 3951-112

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                              -2-


                         REGION  III (4)
BFC Chemicals
PO Box 7495 ...
3509 Sil verside -Rd.
Wilmington, De  19803
EPA Reg.  No: 45639-118

FMC Corp.
Agricultural Chemical Group
2000 Market St.
Philadelphia, Pa  19103
EPA Reg.  No: 279-1841 ,-1854, -1855 ,-1859 ,-2836,
EPA Interstate Accession No: 279-3898, -4037

Royster Company
PO Drawer 1940
Norfolk,  Va  23501
EPA Reg.  No: 4904-334

S.N.P.E.  Stevens Et Al
1911 Jefferson Davis Hwy.
Suite 600, Crystal Mall  #1
Arlington, Va  22202
EPA Reg.  No: 35134-001
                         REGION IV  (17)
Cedar Chemical
Suite 2414 Clark Tower
5100 Poplar Ave.
Memphis, Tn  38137
EPA Reg. No: 56077-003 ,-004 ,-005, -Oil ,-012, -013 ,-014 ,-015 ,-016
-021, -023, -024, -025
                             v •
Cleveland Chemical Company
PO Box 820
Cleveland, Miss.  38732
EPA Reg. No: 8867-025

Drexel  Chemical Company
2487 Pennsylvania St.
PO Box 9306
Memphis, Tn  38109
EPA Reg. No: 19713-023 ,-028 ,-033, -078, -082, -1 10, -203

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                              -3-
Griffin Corporation
Attn.-Linda C. Elliot
PO Box 1847
Valdosta, Ga  31601
EPA Reg. No: 1812-118

Helena Chemical  Company
Clark Tower Suite
5100 Poplar Ave.
Memphis, Tn  38137
EPA Reg. No: 5905-217,
EPA Intrastate Accession No:-7584 ,-7585,-7586,-7587 ,  -7588,
-7593,-7599,-7600,-7601,-7602,-7887,-7888,-7889,-7890, -7891,
-7892,-7893,-7894,-7895

IDA, Inc.
PO Box 9483
2487 Pennsylvania St.
Memphis, Tn  38109
EPA Reg. No: 45115-028,-047,-052

Landia Chemical  Company
P.O. Drawer AO
Lakeland, Fl  33802
EPA Intrastate Accession No: 9859-5637

Laroche Inc.
1100 Johnson Ferry Rd. NE
Atlanta, Ga  30342
EPA Keg. No: 3442-669

Micro-Flo Company
Rt. 1-Box 190
Sparks, Ga  31647
EPA Reg. No: 51036-054,-068

Riverside Chemical Company
Riverside Terra  Corp.
PO Box 171376
Memphis, Tn  38117
EPA Reg. No: 9779-001,-186

Security Chemical  Company
PO Box 938
Fort Valley, Ga   31030
EPA Reg. No: 769-365

Southern Agricultural- Insecticides Inc.
PO Box 218
Palmetto, Fl  33561
EPA Reg. No: 829-197

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                              -4-
Stevens Industrial Inc.
N. Main St.
PO Box 272
Dawson, Ga  31742
EPA Reg. No: 2459-213

Superior Fertilizer and Chemical Company
PO Box 1021
Tampa, Fl   33601
EPA Intrastate Accession No: 3122-7195

Union Carbide Agricultural Products Co.
Office of  Regulatory Affairs
PO Box 12014
T. W. Alexander Dr.
Research Triangle Park, NC  27709
EPA No: 264-363
Valley Chemical Company
PO Box 1317
Greenville, Ms  38702
EPA Intrastate Accession
            No: 1063-3299
Vertac Chemical Company
Suite 2414 Clark Tower
5100 Poplar Ave.
Memphis, Tn  38137
EPA Intrastate Accession No: 39511 -6817,-6818,-6819,-r820,-6821,
-6822,-6823, -6824,-6825,-6826,-6827,-6828,-6829,-6830 ,-6831 ,-6832 ,
-6833, -6834,-6835,-6836,-6837,-6838,-6839,-6849,-6850,-6851,-6853
                          REGION V  (1)
Universal Cooperatives Inc.
Farm Chemical Division
PO Box 460
7801 Metro Parkway
Minneapolis, Mn  55440
EPA Reg. No: 1386-478,-582
                         REGION VI  (7)
Ag-Chemical  Services, Inc
PO Box 1263
McAllen, Tx
EPA Reg. No:
78501
37790-8343

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                               -5-
 Ansul  Chemical  Company
 P.O. Drawer  1165
 Weslaco,  Tx   78596
 EPA  Intrastate  Accession  No:  6308-3010,-3011,-3012 ,-3013 ,-3014

 Apollo  Enterprises  Inc.
 Route  1
 Alteimer, Ar    72004
 EPA  Reg.  No:  13166-013

 DH  Industrial Supply Company
 PO  Box  472
to wie,  Tx  76230
 EPA  Reg.  No:  3797-004

 Micro  Chemical  Company
 PO  Box  711
 Winnsboro, La   71295
 EPA  Reg.  No:  4841-050

 Retzloff  Chemical Company
 PO  Box  45296
 Houston,  Tx   77045
 EPA  Reg.  No:  7472-007

 Wi1  son  Lee &  Company
 Wilson, Ar   72395
 EPA  Reg.  No:  9220-001
                         REGION VII  (4)
The Cropmate Company
320 Embassy Plaza
Omaha, Ne  68114
EPA Reg. No: 1145-095

Hi-Plains Sprayers, Inc.
710 S. Smokey Hill
Oakley, Ks  67748
EPA Accession Number No: 35965-3007

Kaw Val1ey , Inc .
18.01 South 2nd St.
Leavenworth, Ks  66048
EPA Reg. No: 44215-087,-088,-089,-90,-1 25

Platte Chemical Company
150 South Main
Fremont, Ne  68025
EPA Reg. No: 34704-176,-244,-245,-246,-253
EPA Intrastate Accession No: 34704-3860

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                              -6-


                    REGION VIII  (1)
Schall Chemical Inc.
120 N.' '^r oadway
Montevista, Co  81144
EPA Reg. No: 3468-010
                         REGION IX  (18)
AFC Company
PO Box 207
Edison, Ca   93220
EPA Intrastate Accession No: 37177-8221

Arizona Agrochemical Company
ChemicalDistributors
PO Box 21537
Phoenix, Az  85036
EPA Reg. to:  1526-480,-494

Bakersfield Ag Chemical  Inc.
Rt. #1 Box 858
Bakersfield, Ca.  93308
EPA Intrastate Accession No: 11369-8775,-8793

B r i t z Inc.
PO Box 9050
Fresno, Ca  93790
EPA Intrsstate Accession No: 10951-9810

Brown & Bryant Inc.
PO Bin T
Shafter, Ca  93263
EPA Intrastate Accession No: 11373-6981

Gowan Company
PO Box 5696
Yuma, Az  85364
EPA Reg. No: 10163-028
EPA Intrastate Accession No: 10163-6122

J.R. Simplot Co.
Agriculture Chemical Dept.
PO Box 198
Lathrop, Ca  95330
EPA Reg. No: 7001-077,-327
EPA Intrastate Accession No: 7001-4378,-7746

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                              -7-
Newell Chemical Company
1BA Brea Agricultural Service
1905 N. Broadway
Stockton, Ca  95205
EPA Intrastate Accession No: 36998-4464

Puregro Company
1276 Halyard Drive
West Sacramento, Ca  95691
EPA Reg. No: 1202-205,-244

Rockwood Chemical  Company
PO Box 34
Brawley, Ca  92227
EPA Intrastate Accession No: 10226-3751

Russell Chemical Company
PO Box 939
Brawley, Ca  92227
EPA Intrastate Accession No: 11159-7329
Di noseb

Santa  Paula Chemical Company
18115  E. Telegraph Rd.
Santa  Paula, Ca  93060
EPA Intrastate Accession No: 43906-7330

Simplot, J.R. Company
Minerals and Chemical Division
PO Box 198
Lathrop, Ca  95330
EPA Reg. No: 11682-011 ,-012

Soil  Service, Inc.
PO Box 1817
Salinas, Ca  93901
EPA Intrastate Accession No: 6973-3597

Stauffer Chemical  Company
1200 S. 47th St.
Richmond, Ca  94804
EPA Reg. No: 476-1971

Van Waters & Rogers
Agricultural Dept. (Namco)
2256 Junction Ave.
San Jose, Ca  95131
EPA Reg. No: 550-070

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                              -8-
Western Farm Services,  Inc.
C/0 Shell Chemical Co.
3075 Citrus Circle, Suite  195
Walnut Creek, Ca  94598
EPA Reg. No: 11656-00.1
EPA Intrastate Accession No: 11656-5767

Wi1 bur Ellis Company
191 W. Shaw Ave. , Suite 107
Fresno, Ca  937U4
EPA Keg. No: 2935-353,
EPA Intrastate Accession No: 2935-6592,-6593,-6594,-6636,-6661
                          REGION X  (3)
Feed Services Inc.
PO Box 430
Caldwell, Id  83605
EPA Intrastate Accession No: 10914-9304,-9326

Pacific Supply Cooperative
1200 SW Main
Portland, Or  97205
EPA Reg. No: 483-142

Wood Industries
PO Box 1016
Yakima, Wa  98907
EPA Intrastate Accession No: 682-5596
                    FOREIGN PRODUCERS   (1)
Marks & Company Ltd. A H
Wyice Bradford Rd. 12-9EJ
Yorkshire, England
EPA Reg. No: 15440-001

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                              -9-


                          APPENDIX II

                DINOSEB PRODUCER ESTABLISHMENTS*
REGION I  (0)

REGION II  (0)

REGION III  (0)

REGION IV  (4)

Drexel Chemical Co
Tunica Industrial  Park
Tunica, MS   38676
Produces: Sodium dinoseb, Triethanolamine dinoseb,  Dinoseb

Platte Chemical Company, Inc.
North Raceway Road
Greenville, MS   38701
Produces: Alkanolamine dinoseb, Dinoseb

Uniroyal  Chemical
214 Hest Ruby Ave.
Gastonia, NC   28053
Produces: Sodium Dinoseb

Vertac, Inc., Vicksburg Plant
PU Box 3, Rifle Range Road
Vicksburg, MS   39180
Produces: Alkanolamine dinoseb, Ammonium dinoseb,  Dinoseb

REGION V  (3)

ADI Distributors Inc.
430 West Carmel Drive
Carmel , IN   46032
Produces: Sodium dinoseb

ADI Distributors Inc.
8558 Industry Park Drive
Piqua, OH   45356
Produces: Sodium dinoseb

Sweetser Service Cr., Inc.
215 W. Franklinn St., PO Box 188
Sweetser, IN   46987
Produces: Sodium dinoseb
* According to 1985 FATES data.

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                              -10-
REGION V  (0)

REGION VI  (0)

REGION VII  (2)

Macon Exchange Bulk Pert Plant
Highway 63 North
Macon, MO   63552
Produces: Sodium dinoseb

SCF, Inc.
PO Box 101
Levasy, MO   64066
Produces: Sodium dinoseb

REGION VIII  (0)


REGION IX  (5)

Arizona Agrichem - Kyrene Prod. Plant
6751 W. Galveston
Chandler, AZ   85224
Produces : Di noseb

FMC Corp., ACG, Attn.: Delia D. McGoey
Box 1669 2501 Sunland Ave.
Fresno, CA   93717
Produces: Ammonium dinoseb

Helena Chemical Company
1075 S. Vineland (PO Box 305)
Kerman, CA   93630
Produces: Dinoseb

Occidental Chemical Company
16777 S. Howland Avenue
Lathrop, CA   95330
Produces: Dinoseb

United Agri  Products
PO Box 2357 (3173 So. Chestnut)
Fresno, CA   93745
Pr'oduces:L)inoseb

REGION X  (1)

J.R. Simplot Company DBA Sim-Chem
E of Boise,  Exit 74, Simco Rd.
Mountain Home, ID   83647
Produces: Dinoseb

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                    COMMUNICATIONS STRATEGY
                          FOR DINOSEB
 BACKGROUND;

     The Agency has been reviewing  all  available dinoseb  data  as
 part of the  reregistration  process.  In conjunction  with this
 review, a Data Call In Notice  (DCI)  requesting ground  water and
 toxicology studies was issued  on June  13, 1984.   In  response
 to this DCI,  two teratogenicity studies were submitted  in May,
 1986 which demonstrated that dinoseb causes developmental
 toxicity in  laboratory animals and may pose a risk of  birth
 defects in pregnant women.  This risk  is greatest for  those
 women exposed at the dinoseb application site.

     EPA has'  also reviewed reproduction studies which indicate
 that dinoseb  has the potential to cause male sterility.

     Dinoseb  is a contact herbicide widely used to control broad-
 leaf weeds.   Cotton, potatoes, and soybeans comprise 71% of the
 chemical use.   Additional uses include: alfalfa, almonds,
 grapes, peanuts, peas, snap beans, and ornamentals.
"ACTION  BEING  TAKEN;

     After  considering  a range of regulatory options to mitigate
 exposure  to dinoseb,  the Agency has decided to emergency suspend
 all  registrations.   In conjunction with this action, a Notice
 of  Intent  to  Cancel  all dinoseb registrations is being issued.

     The Administrator  has determined that continued registration
 of  dinoseb poses an  imminent hazard during the period in which
 administrative hearings could delay the effectiveness of the
 cancellation  of these  registrations.
                     * /,
 MESSAGE;

     The Agency has determined that use of products containing
 dinoseb is an imminent hazard to human health due to significant
 exposure  to applicators, particularly pregnant women.  This
 regulatory decision  will eliminate all risks to applicators,
 bystanders, and field  workers.  There is no dietary exposure
 of  concern.         "  .                 •                 .

     Numerous  alternatives exist for most use sites of dinoseb.
 Paraquat  and  diquat  are considered to be the two major
 alternatves.   ICI Plant Protection Division (Great Britian) is
 the major  producer of  these two chemicals. _.^.

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                           Dinoseb
                 Telephone Notification List
  RESPONSIBLE PARTY
   Mike McDavit
  Jill Collins
 Cathleen Mclnerney
  PERSON TO BE CALLED         PHONE*

  WITHIN EPA

  Jim Lamb (OPTS)             382-2892
  Jan Peck (OPTS)             382-2906
  Cathleen Mclnerney (OPP)    557-7102
  Jill Collins (OPA)          382-4355
  Larry Cook  (OGC)            382-7505
  Al Jennings (OPPE)          382-4005
  Gus Conroy  (OCM)            382-3807
  Joy Wilson  (AA/OEA)         382-5654
  Alan Seilen (OIA)           382-4875
  Richard Longmire  (OPP)      557-9351

  Bill Prendergast  (OCL)      382-5200
  Al Heier (OPA)              382-4374
  Andy Robart (OPPSL)         382-4454
  Priscilla Flattery (OPA)    382-4387

  Phil Gray (OPP)             557-7096
  John Ulfelder  (OA)          382-7960
                         EPA REGIONS
        (to be called two days prior to announcement)
Susan Wayland


Priscilla Flattery
 Regional Division Directors
 (conference call; OCM to attend)
'f
 Regional Public Affairs Officers
 Cathleen Mclnerney
   .- ,0MB

 Carlos Tellez, OMB
395-7340

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                                -2-  ' "
RESPONSIBLE PARTY          PERSON  TO BE  CALLED             PHONE »


                            CONGRESS

Bill Prendergast            Gary Mitchell,                 225-2342
                            Tim Galvin,                    225-4452
     "         '•.•'•-."         Skip Stiles,                   	
                            House  Agriculture
                            Subcommittee Staff

                            Mario  Castillo,                225-2171
                            House  Agriculture
                            Committee Staff

                            Chuck  Connor,                  224-6901
                            Senate Agriculture
                            Committee Staff

                            Ron Outen,                     224-7814
                            Senate Environment &
                            Public Works Committee
                            Staff
                               STATES
            (to be  called one day  prior  to  announcement)
   Phil Gray            .    L.O.  Nelson,
                            SFIREG/AAPCO
                            Indiana
                            Bob Ehart,                     	
                            Wisconsin

                            Rodney Awe,                (208) 334-3243
                            Idaho
                            Robert McCarty,                	
                            Mississippi                    •  .
                        »/,
      "t                    . Art Losey,                     	
                            Washington


  Mike McDavit             Clare Berryhill,           (916) 322-6315
       "•                     CA Dept.  of  Food & Agriculture

      "     '          ''     Bob Batteese
                   ; .      .  Maine                     (207) 289-2731

                            Kay Evans                 (207) 289-3871
                            Maine  .

                            Jeffrey Carlson,   >£      (617) 727-2863
                            Massachusetts

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                                -3-
R2SPONSIBLE  PARTY

   Mike McDavit


 Region I
 Region  II
 Region  III
 Region  IV
 Region V
 Region VI
 Region VTI
 Region VIII
  Region IX
PERSON TO BE CALLED

 Van Kozak,
 Texas,Dept. of Ag.

 Vermont
 New Hampshire
 Connecticut
 Rhode Island

 New York
 New Jersey
 Puerto Rico

 Pennsylvania
 West Virginia
 Virginia
 Maryland • •
 Delaware

 North Carolina __
 South Carolina
 Georgia
 Florida
 Alabama
 Tennessee
 Kentucky

 Ohio
 Michigan
 Illinois
 Minnesota

 Arkansas
 Louisiana
 Oklahoma
 New Mexico

 Iowa
 '•Missouri
 Kansas
 Nebraska

 North Dakota
 South Dakota
 Montana
 Wyoming   .
 Colorado
 Utah

 Arizona
 Nevada
 Hawaii
TELEPHONE S

(512)463-7545
  Region X
  Oregon
  Alaska

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                               -4-
RESPONSIBLE" PARTY
  Andy Robart
  PERSON TO BE CALLED

        ' STATES

 .   .  J.B.  Grant,  NASDA

      Bob Jackson,  ASTHO

      Jim Solyst,  NGA
TELEPHONE
         628-1566
  Mike McDavit
      .11-
INDUSTRY and USER GROUPS

     John Baize,
     American Soybean
     Association

     Dr.  James Brown,
     National Cotton Council
                  _!•
     Harold Collins,
     National Agriculture
     Aviation Association

     Jack Early,
     National Agriculture
     Chemicals Association

     Ralph Engle,
     Chemical Specialties
     Manufacturers Association

     Tom Ford,
     National Potato Council

     David Hamilton
     American Association of
  . ..  Nurserymen

     Robert Keeney
     United Fruit and
     Vegetable Association

     Robert Kirshner
     National Forest Products
     Association

     Dave Lambert
     American Seed Trade
     Association
         554-7804


     901/274-9030




           546-5722




         •  296-1585




           872-8110




       303/589-4787
            /

           789-2900




           836-3410


              *

           797-5800

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  SPONSIBLE PARTY
                             -5-
  PERSON TO BE CALLED
                           INDUSTRY
  Mike McDavit
  Denise Larr,
  Pesticide Producers
  Association

  Mark Maslyn,
  American Farm  Bureau
     429-8405
                                                          484-2268
      FARMWORKER/LABOR/AGRICULTURE/ENVIRONMENTAL GROUPS
Richard Longmire
  Andy Robart
 Fernando Cuevas,
 Farm Labor Organizing
 Committee
305/887-2949
                        Rebecca Harrington,          512/474
                        United Farm Workers (AFL-CIO)
                        Chip Hughes,
                        East Coast Farm Worker
                        Support Network
                                      5010


                              919/682-3818
 Ralph Lightstone,
 California Rural Legal
 Assistance

 Dr. Marion Moses,
 United Farm Workers  (AFL-CIO)

 Baldemar Velasquez,
 Farm Labor Organizing
 Committee

 David Cavenaugh,
"National Association of
 Community Health Centers

 Maureen Hinckle,
 National Audubon Society

 Diane Baxter/
 National Coalition Against
 the Misuse of Pesticides
916/446-1416



415/731-6569


419/243-3456



    833-9280



    547-9009


    543-5450

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 RESPONSIBLE PARTY
     -6-

  ' PERSON TO BE CALLED
       .: AGRICULTURE /ENVIRONMENTAL GROUPS
Andy Robart
Lawrie Mott,
Natural Resources
Defense Council/ SF

Ellen Silbergeld,
Environmental Defense
Fund

Norm Dean,
National Wildlife
Federation

Neil Fitzpatrick,
Audubon Naturalist
Society of the Central
Atlantic States, Inc.

Shirley A. Brigge,
Rachel Carson
Council, Inc.
                     National Parks and
                     Conservation Assn.

                     Geoffrey Webb,
                     Friends of the Earth

                     Michael Clark,
                     Environmental Policy
                     Institute

                     Lucky Wentworth,
                     Izaak Walton League
                     of America

                     "Douglas Wheeler,
                     Sierra Club

                     Bob Fredrick,
                     National Grange

                     Paul Sacia,
                     National Farmers Union

                     Pat Quinn,
                     National Council of
                     Agricultural Employers
     PHONE #
415/421-6561
                                                       387-3500
                                                        797-6800
                                                        652-9198
                                                       652-1877
                                 547-5330



                                 528-1818






                                 628-3507


                             554-1600


                             554-6400

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                              -7-


1CESPONSIBLE  PARTY        PERSON TO BE CALLED           PHONE 3


                   AGRICULTURE/ENVIRONMENTAL GROUPS

 Andy Robart   '     '     Randy Jones,                  659-1525
                          National Council of
                          Farmer Cooperatives

     t "                    Larry Silverman,              	
                          American Clean Water
                          Association

     "                    Lois Ellison,                 	
                          American Lung Assn.

     "                    Katherine McCarter,           	
                          American Public Health
                          Association
                           •

     "          •          Bambi Young,    _              	
                          Center for Science in
                          the Public Interest
                          Consumer Federation of
                          America

                          Rose Audette,
                          Environmental Action

                          Phillip Reed,
                          Environmental Law
                          Institute

                          Sydney Wolf,
                          Health Research Group

                          Nancy Neuman,
                          League of Women Voters
                          Migrant Legal Action
                          Program

                          Nat Williams,
                          Nature Conservancy

                          Joan Claybrook,
                          Public Citizen

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                             -8-
RESPONSIBLE PARTY
  Andy' Robart
PERSON TO BE CALLED

Dianne Barzman,
Public Voice for Food
•and Health Policy

Paul Portney,
Resources for the
Future

Larry Jahn,
Wildlife Management
Institute

Debbie Berkowitz,
Food and Allied Services
Union

George Koch,
Grocery Manufacturers
Association    -*

Charlie Mack,
Food Industry Assoc.
Executives

Harry Sullivan,
Food Marketing Institute

Robert Fersh,
Food Research and Action
Center

Melanie Miller,
National Peanut Council

Robert Keaney,
United Fruit Growers
 TELEPHONE *
                        Florida Fruit &
                        Vegetable Assn.
                                              (305
                        Jack Cooper,
                        National Food Processors
                        Association

                        Erik Jansson,
                        National Network to
                        Prevent Birth Defects
  737-7200



  337-9400



  296-8951



  452-8444


  393-5060



  775-0450


  836-3410


)  984-1351



  639-5900



  543-5450

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RESPONSIBLE PARTY
                              -9-
PERSON TO BE CALLED
                        OTHER'FEDERAL AGENCIES
 TELEPHONE *
  Phil Gray
 Cathleen Mclnerney
 Charles Smith,
 Pesticide Assessment
 Program/USDA

 Jim Parochetti,
 Cooperative Extension
 Service/USDA

 Ken Williams,
 Office of Migratory
 Birds,  Fish and
 Wildlife Service,

 John Wessel,
 FDA
 USDI

 Larry Kline,
 Office of Endangered
 Species, UDSI

 Sanford Miller,
 Bureau of Foods/HHS

 John Wood,
 APHIS/USDA
    447-4751
                                                       447-6506
    235-2760



    245-8850


    436-8896
        INTERNATIONAL AGENCIES and FOREIGN GOVERNMENTS
 Alan Seilen
Cathleen Mclnerney
 Pep Fuller,
 U.S. Trade Representative
 St
 Tom Wilson,
 U.S. State Department

 Carroll Collier,
 Agency for International
 Development

 Wayne Ormrod,
 Plant Products -and
 Quarantive Directorate,
 Agriculture Canada

 Pierre Mineau,       .,.-
 Canadian Wildlife
 Service
613-995-7900
                                                   819-997-6121

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                             -10-
MAILINGS;

     The Registration Division (RD) will mail copies of the
document to pesticide registrants (the FR notices will be
mailed prior to publication).  RD will also mail the document
to trade organizations, EPA Regions, other Federal agencies,
State officials and key EPA employees.  The Office of External
Affairs will send copies to Congress, environmental groups,
and intergovernmental groups, as appropriate.

-------
Friday
February 17, 1989
Part IV
Environmental

Protection Agency

Dinoseb Pesticide Products; Procedures
for Submission of Claims for
Indemnification and Requests for
Disposal; Amended and Final Notice

-------
 7372
Federal Register / Vol. 54.  No. 32 / Friday. February 17, 1989 / Notices
ENVIRONMENTAL PROTECTION
AGENCY

[OPP-150003A; FRL-3523-3!

Dinoseb Pesticide Products,         •:
Procedures for Submission of Claims
for Indemnification and Requests for
Disposal; Amended and Final Notice

AGENCY: Environir.ent.-il Protection
Agency.
ACTION: Final notice; procedures for
requesting indemnification and disposal
for pesticide products containing
Dinoseb.

SUMMARY: This Notice amends an April
15  19U7. Fe^-ral Register Notice by
announcin   ml EPA :s again accepting
claims for *.j t«mnification and/or
requests fo.  disposal for all suspended
and cancelled dinoseb-containing
pesticides under sections 15 and 19 of
the Federal Insecticide. Fungicide, and
Rodenticide Act (FIFRA), 7 U.S.C. 136 m
and q (prior to the FIF11A amendments
of 1988). On June 9. 3.938. the EPA
Administrator issued a Final Order
which concluded the cancellation
hearing on dinoseb, cancelled the
registrations of all remaining dinoseb
products, and provided for limited use of
existing stocks under certain specified
conditions. This Notice provides
information on eligibility and
procedures to owners of dinoseb stocks
who may wish to seek indemnification
for losses suffered as a result of
regulatory actions taken by EPA and/or
Federal disposal assistance.
DATES: Claims and requests filed in
response to this Notice for products
which may not be used on caneberries
in Washington and/or Oregon, must be
submitted by June 19,1969. to be
considered  bairns end requests for
products wt ;:.ii may be used on
caneberries in Washington and/or
Oregon should not be submitted until
after June 15,1989. These latter claims/
requests must be submitted before
August 15,1983, to be considered.
ADDRESS: All claims and requests filed
in response to this Notice should be
mailed to: Resource Management and
Evaluation Branch (TS-757C), Office  of
Pesticide Programs, Environmental
Protection Agency, 401 M Street SW..
Washington. DC 20400, Attpntion:
Stanley Cook.
FOR FURTHER INFORMATION CONTACT:
By mail: Stanley Cook. Resource
  Management r.nd Evaluation Branch
  (TS-757C). Office of Pesticide
  Programs, Environmental Protection
  Agency. 401 M Street SW..
  Washington, DC 204GO
                    Office location and telephone number:
                      Room 1002, CM*2.1921 Jefftrson
                      Davis Highway. Arlington. VA, 1-000-
                      DIN-OSEB {in"Maryland call 1-800-
                      331-3704).
                    SUPPLEMENTARY INFORMATION: EPA is
                    issuing this amended Notice because uil
                    suspended dinoseb registrations have
                    now been cancelled, and holders of
                    stocks of these products may be eligible
                    for indemnification and/or Federal
                    disposal assistance. This Notice
                    discusses how claims for
                    indemnification and requests fur Fr.uura!
                    disposal should be prepared and
                    submitted to EPA. It also instructs
                    persons who responded to the April 15.
                    19G7, Notice how to affirm, amend, or
                    withdraw a previously submitted claim
                    and/or request, or to submit a claim for
                    indemnification and/or request for
                    disposal assistance for previously
                    ineligible products.
                      This Notice establishes two time
                    periods with separate deadlines for
                    owners to submit claims for
                    indemnification and/or requests for
                    disposal. Owners of products which
                    may not be used in 1989 on caneberries
                    must file claims/requests during the first
                    time period. Owners of products which
                    may be used on caneberries must file
                    claims/requests during the second time
                    period. Procedures for filing claims/
                    requests are discussed in Unit II. of this
                    Notice. Unit II. B. lists products for
                    which claims/requests may be
                    submitted during one of these two time
                    periods.
                      This Notice also discusses the interim
                    storage, transportation, and disposal of
                    dinoseb stocks. EPA has awarded
                    contracts to two waste management
                    firms for the disposal of dinoseb. It is
                    the responsibility of the holder to store
                    the dinoseb safely and transport it to
                    EPA's designated facility when EPA is
                    ready to receive the stocks.

                    I. Background
                    A. Legal Standard
                      Section 6 of FIFRA authorizes the EPA
                    Administrator to take certain actions .to
                    prohibit sale, distribution, and use of
                    pesticide products that pose
                    unreasonable adverse effects to human
                    health or the environment. If use of a
                    pesticide poses a risk that outweighs the
                    benefits of continued use, the pesticide's
                    registration may be cancelled and/or
                    suspended. If action is necessary to
                    prevent an imminent hazard to human
                    health or the environment, the
                    Administrator may announce his intent
                    to suspend a pesticide registration at the
                    some time he issues a Notice of Intent to
                    Cancel. If an emergency exists which
                    does not permit the Administrator to
hold a hearing before suspending a
pesticide registration, he may issue |
Emergency Suspension Order which'
immediately halts ail use, Sole, and
distribution of the pesticide. Adversely
affected persons may request, within
certain time frames, a hearing to
challenge EPA's suspension. After an
opportunity for a expedited hearing, a
Final Suspension Order can be issued.
Abo in accordance with section 6 of
FIFRA, a Notice of Intent to Cancel urui
deny registrations provides that a
pesticide product would be cancelled 30
days after publication of the
cancellation notice or its receipt by the
registrant unless the registrant or other
adversely effected  s:son requests a
hearing to contest the cancellation of
that registration.
  Prior to its amendment in December
1988. section 15 of FIFRA required the
Administrator to make indemnity
payments to owners of pesticides
suspended and cancelled under section
6 who suffered losses by reason of the
Agency's actions. The statute provided
that indemnification is payable to any
person under the following conditions:
  1. The Administrator suspended the
registration to prevent an imminent
hazard.
  2. The registration was subsequent
cancelled.
  3. The person owned some quunti?
the pesticide immediately before the
suspension.
  4. The person suffered losses by
reason of the  suspension or cancellation.
Under section 15(b), the amount of
indemnity payment was to be
determined on the basis of the cost of
the pesticide owned by the person
immediately before thr suspension, but
could not exceed the pesticide's fair
market value at that time.
  Also prior to the 1S88 amendment;,.
section 19[a) of FIFRA and the.
regulations promulgated pursuant to it «t
40 CFR Part 165 required Administrator
to accept at convenient locations for
safe disposal  these pesticides the
registrations of which have been
suspended and cancelled as specified in
section 6(c), if requested by the owner of
the pesticide. However, before the
owner of a pesticide requests such
acceptance, he/she must make every
reasonable effort to return the material
to the manufacturer, distributor, or other
agents capable of relabeling, recovering.
recycling, or reprocessing the muterin.l
(See 40 CFR 135.4).
  Both sections 15 and 19 of FIFRA were
substantially  amended by Pub. L.'
532. the FIFRA Amendments of 198
which was given into law by the
President on October 25,1988. EPA docs

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                    Federal Register /  Vol.  54, No. 32 / Friday,  February 17.  1989 / Notices
                                                                                                               7373
are
in
 not believe that the 1988 amendments
       iicable to its current dinoseb
         cation and disposal program.
          y. all references in this Notice
 !o sections 15 and 19 of F1FRA refer to
 the law as it existed prior to the 1938
 ;!inendmer.;3.
   B;ised en information about the
 adverse human health an:i
 environmental risks pose- by Jinr.st b-
 cnntuir.in.™ pesticide prod;: J.s, on
 October 7. 19;;6. the Admi;;;.,;rator
 issued an Emergency Suspension Ordor
 for all registrations of pesticides
 containing the active ingredient dincseb.
 it immediately prohibited all further
 sale, distribution, and use of dinoseb
 products. Notice of this action was
 published in the Federal Register of
 Gclober 14, 1086 (51 FR 3663-i). Although
 four registrants requested e hearing
 concerrir.g whether the suspension of
 dinoseb products should remain in
 effect, these requests were withdrawn
 on October 30, 1986, resulting in
 immediate entry of a Final Suspension
 Order.
.   Also on October 7, 1986, the
 Administrator issued a Notice of Intent
 to Cancel and deny registrations of all
 dinoseb-containing pesticide products,
 published in the Federal Register of
         4, 1986 (51 FR 3G650). Upon the
         n of the applicable 30-day
             dinoscb registrations were
 cancelled by operation of law. However.
 several registrants requested hearings
 contesting the EPA's cancellation an'ion.
 These registrations were suspended, but
 not cancelled, pending  the outcome of
 an administrative hearing.
   Prior to issuance of a Final
 Cancellation Order, certain actions were
 taken which resulted in modification of
 the Suspension Order on dinosob. First,
 EPA was petitioned under Subpart D of
 40 CFR Part 154 to modify the Final
 Suspension Order to permit use of
 dinoseb on certain crnps. Following an
 administrative hearing, on March 30,
 1{|.37.  the Administrator issued a
 Decision and Final Order Modifying the
 Final Suspension of Pesticide Products
 which Contain Dinoseb. This order and
 the FIFRA section 18 emergency
 exemptions which implemented it
 allowed limited use of FIFRA during the
 1987 and 1S80 growing  seasons on dry
 peas, lentils, and  chickpeas in
 Washington and Idnho. A subsequent
 order pmmitted use on the same crops in
 certain counties of Oregon.
   So.'ionJ, following a complaint filed in
 tli./ U.S. District Court for ths District of
           a number of user groups, the
          :-! Order on dinoseb w;;s
         on April 15, 1U37, with respect
to certain crops in the Pacific Northwest.
Love v. Thomas. 6G8 F. Supp. 1143 (D.
Oregon 1987). affirmed in part 833 F. Zd
1039 (9th Cir. 1S38). In particular, the
District Court ruling enjoined the
Suspension Order as it applied to
dinoseb use on cur.cberrios, cucurbits.
green peas, and snrs? beans in th? Stales
of Iddho, Ore^-n, and Washing:on.
  Cn ;-jne 9 1533, the Adminisirator
issued a Fincii Cancellation Order on
dinoseb. cancelling all remaining
registrations. However, the Order
provided for limited use of existing
stocks of dinusob on specific crops in
the Pacific Northwest during the 1988
and 1009 growing seasons. The Order
permitted existing stocks of all
cancelled dinoseb products which were
previously labeled for use on peas,
lentils, or chickpeas to be sold.
distributed, and u.icd for weed control in
dry peas, Icr.tils. chickpeas, and green
peas in the States of Idaho. Oregon, and
Washington during the 1968 use season.
In addition, the Order permitted existing
stocks of ai! cancelled dinoseb products
previously labeled for use on
cancberries (blackberries,
boysenberries, loganberries, and
raspberries) to be sold, distributed, and
used for cane control in these crops in
the States of Oregon and Washington
for  the 1983 and 198? use s£asons. The
1939 caneberry use in Washington end
Oregon is the only allowable use
remaining ai this time.
  The Final Cancellation Order was
challenged in the same District Court of
Oregon, which initially issued a
preliminary injunction partially staying
the Order. However, the Court
ultimately concluded it did not have
jurisdiction to review the Order and. in
the alternative, entered judgment
sustaining the Administrator's decision.
Northwest Food Processors v. Thomas,
N-88-641-RE (D. Oregon Sept. 25,1988).
The Northwest Food Processors
Association previously filed a petition  in
the Ninth Circuit Court of Appeals
seeking review of the cancellation order
and has also appealed the  Federal
District Court decision to the Ninth
Circuit Court.
C. April 15.1987 Federal Register Notice
  EPA issued a notice, published.in the
Federal Register on April 15.1937 (52 FR
12352), announcing that pursuant to
sections 15 and 19 of FIFRA it was
accepting claims for indemnification
and/or requests for disposal assistance
for  dinoseb pesticide products that were
suspended and cancelled. The April 15,
19137 Notice described procedures and
set a deadline of July 14,1987 for filing
claims and/or requests for eligible
products. As described in the April 15,
1987 Notice, eligibility did not extend to
suspended dinoseb registrations which
h.\d not been cancelled (i.e., those
registrations for which registrants had
requested a cancellation hearing).
Although such products were not
eligible for indemnification and disposal
assistance at that time, EPA requested
holders of these ineligible products to
provide the Agency with certain basic
information, such as location and
quantity of their stock. EPA requested
this information to be able to estimate
the total quantity and location of all
dinoseb products which could become
eligible for indsmiiificutiOE and disposal
assistance if the registrations of such
products were eventually cancelled.
  In response to  the April 15,1987
Notice, EPA received over 1200
submissions. About one-third of these
were for products eligible at that time
for indemnification and disposal
assistance, and the others were for
products that were not eligible. All
submissions were assigned claim or file
numbers and information from the
aggregate was used to estimate the total
amount and location of dinoseb stocks.
EPA has been reviewing these
submissions and has contacted some
people regarding their claims/requests.
EPA has made a  number of offers to pay
indemnification to owners, and is
processing these  claims as the
acceptance agreements are returned  by
the owners. The Agency will be
contracting all other people who
responded to the April 15,1987 Notice
regardless of whether their products
were eligible or ineligible for
indemnification or disposal at the time
of their initial submission. EPA
appreciates the cooperation of holders
of suspended-only products who
responded to the April 15,1987  Notice.
The information helped expedite the
dinoseb indemnification and disposal
program.
  After the publication of the April 15,
1937 Notice, and  prior to issuance of a
Final Cancellation Order, several
registrants who had requested a
cancellation hearing withdrew their
requests and, in so doing, their dinoseb
registrations were cancelled by
operation of law. Once cancelled,
owners of such products were eligible to
seek indemnification and disposal
assistance. For example, the
registrations of L'niroyal Chemical
Company dinoseb products were
cancellations on  June 19. 1987 when
Uniroy.il withdrew from the hearing. At
that point, dinoseb products registered
by Uniroyal became eligible for
indemnification and disposal assistance.
However, many owners of Uniroyal

-------
7374
Federal  Register / Vol. 54, No. 32 / Friday. February 17, 19N9  /  Notices'
products may not have been aware of
the cancellation and their subsequent
eligibility. This Notice serves, in part, to
announce that owners of Uniroyal
products registered by other companies
who withdrew from the hearing after the
April 15.1987 Notice was issued art'
now eligible to file claims for
indemnification ar.J requests for
disposal and nur-l file claims/requests
as outline J in Unit II. of this Notice.

ii. Requirement? for Indemnification and
Disposal

.'{. Who is Eiis-i>!e to File Claims fur
Indemnification ar.ct Requests fur
Disposal?

I. General

  All federally registered dinoieb
products, including products with
Special Local Need registrations (under
section 24{c] of FIFRA), have been
suspended and cancelled. Accordingly.
owners of these cancelled dinoscb
products including registrants,
manufacturers, distributors, retailers,
and users may submit claims for
indemnification and requests for
disposal, provided that the cancellation
occurred after the October 7,1986
Emergency Suspension Order end the
other conditions specified in this Un.it
are met.

2. E'.iect of Intrastate Registration

  At the time of the October 7, IQIiO
Emergency Suspension Order, certain
product.1; containing dinoseb were being
marketed under State pesticide
registrations with applications for
Federal registrations pending before
EPA in accordance with EPA regulations
at 40 CFR 162.17. Applications for these
intrastate products were pending on
October 7,1906, when EPA issued a
concurrent Notice of Intent to Deny all
pending applications for Federal
registration of these products.
  The denial of Federal registration for
these intrastate products was analogous
to cancellation. A U.S. Claims Court
decision in Gro-Green Products, Inc. vs.
United States.  3 Cl. Ct. 639 (1983), held
that in similar circumstances a claimant
who held stocks of an intrastate
pesticide product containing silvex was
entitled to indemnification. Accordingly,
persons with dinoscb products that were
previously marketed under pending
intrnstate applications may also be
eligible for indemnification and
disposal, and must cubrr.it any claim
during the first time period established
in Unit II. E.
                    3. Effect of Section 18 Emergency
                    Exemptions, the District Court Rulings
                    and li:<: Fin;.l Cancellation Order
                      The Final Cancellation Order
                    fuptrccdeu ali sale, distribution, and
                    use of dinc-fi'b v.ndnr ihc section 18
                    emergency i x; mptiuns or the District
                    CoLrt rulings. However, as discussed
                    above, the Final Cancellation Order
                    P?r:r.iMcJ the sale-, distribution, and use
                    of dinoseb for certain crops in 1900 and
                    19o9.1'ersons who used dinoseb under
                    the section 18 emergency exemptions,
                    thn District Court rulings, or the existing
                    stoc! s provision (for uses other than on
                    cancbc-rrics) in the Cancellation Order,
                    end who have not cubmitted a ciaim for
                    inc'.emnification. must now do so.
                    Further, if ihry have previously
                    submitted a claim/request or
                    information they must now affirm,
                    amend, or withdraw it. Such amended
                    claims/requests must reflect any
                    product that was used or sold for one of
                    these uses. However, if a dinoseb
                    product may be used on caneberries
                    during the 1989 use season, they should
                    not submit a claim or emend a claim
                    until the second time period as
                    discussed in Unit II. E.
                      Owners/holders of dinoseb should
                    remember that products for which
                    existing stocks may still lawfully be sold
                    or used under the Cancellation Order
                    include any products labeled for
                    caneberry uses, whether or not they
                    were cancelled prior to issuance of the
                    Order. Such products must be used only
                    in full compliance with all of the
                    stringent use restrictions required under
                    the Order, and supplemental labeling
                    containing all of the use restrictions
                    must accompany the product when it is
                    sold or distributed. Holders of these
                    products may use, sell, or distribute
                    their dinoseb stocks in Oregon and/or
                    Washington during the 1989 caneberry
                    use season in conformity with  the
                    Cancellation Order. Owners/holders
                    who previously submitted claims/
                    requests on these products and whc
                    subsequently use, sell, or distribute
                    some or all of their stock must amend
                    their claim accordingly and notify EPA
                    during the second time period as
                    discussed in Unit II. E.
                    4. Ownership requirement
                      Any person who owned some quantity
                    of a registered dinoseb pesticide product
                    immediately before the registration of
                    that product was suspended, or who
                    subsequently received a permissible
                    assignment of the original owner's claim
                    or a power of attorney from the original
                    owner to file the claim, may ciaim
                    indemnification for the product. Claims/
                    requests rr.ay be filed by persons
repn-senting. in some legal
product owners at the time of
suspension or cancellation.
  A "pov.'(-r of attorney" is a don.'.mcn;
whicli appoints someone other than the
actual product owner (the registrant, for
exan-j-.h.J as an n?>cnt of the product
ownt.-r. In this in&lance, uuch a docu/ne'it
merely givjs an ayent the a;itiiori!\ to
submit an indemnification claim and
receive payment on the owner's behalf.
The claim remains that of the pesticide
owner.
  EFA encouraged regisiraiUs to rcciili
their products from distributor and
retailers, so that ihe dinoscb products
would be consolidated. If a registrant
recalled its products,  the registrant
could obtcin assignment of the original
owner's claim. The document of
assignment transfers the pesticide
owner's right of indemnification to the
other person. The pesticide owner
thereafter has no legal interest in the
claim. Samples of a "power of attorney"
end assignment documents are provided
in an Appendix to the Dinoseb Claim
Form. Forms are available from the
regional offices listed in Unit II. D. of
this Notice.
  The Federal Anti-Assignment of
Claims Act would ordinarily bar an
assignment of a claim that occurred
before the claim was  allowed. As
in the April 15,1987 Notice. EPA p
to waive this prohibition against "esirly"
assignments with regard to otherwise
valid claims for indemnification under
section 15 of FIFRA. However, EPA
intends to waive this  prohibition only
with respect to an assignee who took
back the product as part of a recall or u
seller who subsequently accepted
relumed stocks from purchasers.
  Owners such as end-users and
dealers/distributors who have acquired
stocks of dinoseb products since
October 7,198G, will not be eligible for
indemnification for such stocks even if
the products were acqiu'red  in a lawful
manner because these people did not
own the product on the date of
suspension. EPA will not waive the
Anti-Assignment of Claims Act
prohibition against assignment of
indemnification claims for these
products because waiver of this
prohibition would not be consistent with
the purposes of the Act. Claims for
indemnification belong only to the
person v/no owned such stcdcs on
October 7,1965 and may not be assigned
to anyone else unless such assignment is
part of a recall or return cf stocks to
suppliers.
  EPA suggests that any dealer or u
who acquired stocks of dinoseb
products after October 7,1986, which

-------
                    Federal Register  / Vol. 54. No.  32 / Friday. February 17.  1989 / Notices
                                                                         7375
 he/she cannot or does not intend to •
           l or use should attempt to
           stocks to the party who
            on October 7,1986. Only
 that party is eligible to receive any
 indemnity payment for remaining
 stocks. Likewise, any person who
 intends to acquire dinoseb for the lawful
 •,!se permitted under the Final
 Cancellation Order should be cautioned
 that he/she would not be eligible for
 inde.iinitication for that particular stock.
 if any is unused at the end of the 10D9
 use siuson, because he/she was not its
 o-.vnor or. October 7,1936. However.
 ever, if it is not possible to return
 r«;:iainirig stocks of a cancelled
 pesticide product to the  original own:.;?.
 '.he new holder may submit a request far
 Fcdeni disposal assistance if the storks
 nre -./Jierwise eligibla.
  hi-A rs^uires information from the
 claimant on the current ownership end!
 ior.atic;i of the product, as well as the
 ownership at the time of suspension. For
 purposes of rietsrmining who owned the
 product at the time of suspension,  the
 operative date is October 7,1080.
 5. Loss Requirement
  Tr.o amount of indemnity payment is
 to be determined on the  basis of the cost
 of the pesticide owned by the person
 immediately before suspension, but car.
 n.-.t^j^d the pesticide's fair r.-.arket
 \ :il^HEh3t time. Owners can recover
 ir.d-jrSfilieation only for losses suffered.
Therefore, anyone who legally sold or
 used any dinoseb products after Oc'ober
7.1986 (e.g., as legally permitted under
section 18, the District Court injunctions.
 or the Final Cancellation Order) must
 rr.ake appropriate adjustments en  his/
 her claim. The total amount of "loss"
 sustained by the owner for a given
 amount of a dinoseb product mast be
 reduced by the proceeds of any sale or
distribution of that product. Any owner
 who uses a giver, amount of a dinoseb
 product has eliminated those "losses"
 th.-;t might otherwise have been
 sustained as a result of suspension and
cancellation cf the aiiount of product.  A
claimant is not entitled to an indemnity
payment for any amount of dinoseb
product for whi'jh losses were recovered
 through sale or use.
K. Wt:a! Products Are Eligible for
indemnification and Disposal?
  The following lists include all dinoseb
 products that arc now eligible for
 !iiderr.,".iirication and Federal dispoiiul
.•issis'j.HCH. List A contains products for
 which no cunebOiTy uses are permiitcd.
  d for which EPA is now accepting
        ,'qut!s!s. Claims/requests  for
        in List A must be submitted
        e first time period specified in
Unit II. E. List B contains products which
may be used on caneberries in
Washington and/or Oregon during the
1989 caneburry season. Claims/requests
for products on List 5 should not be
submitted to EPA until the occoid time
period specified in Unit II. E.
  Most pesticide product labels contain
an EPA registration number (usually
designated as "EPA Rc«. No. 999909-
99<:D"J and an EPA establishment
nu.-n.bfr (usually designated as "EPA
Est. No. 99999"). The owner should
locate the EPA registration number and
use that for identifying his/her
produr.'(s) and for completing the form.
The owner should not use the EPA
establishment number for identifying
his/her prodact(s). Th:it nur/.jer is not
sufficiently specific 'c be useful for the
dir.nseb indemr.if'sution and disposal
program. Some pro Jjct labc's list a
nvjistra'.ion number thai begins with the
letters "SLN" and i'-.cn c iwo letter State
abbreviation, fciiaw?::.! by 3 6-J;git
number. Thsse are c.iiJed scr.tirvi 2t(c)
or L-pecial Local Ner.-_ •egislrations and
are legitimate EPA rcjis'.ntion numbers.
In rare cases, pesticide product labels
do not contain an EPA registration
number. Theae are probably "intrastate"
products that have never received a
FedDral registraticn number. For thpse,
the owner should uja tho State
registration r.nrr.ber provided en th«
label  to identify :he prcductU) and Tioto
on the form that no EPA rogistration
number is present on the l.ihel.

LIST A—PRODUCTS THAT MAY NOT  BE
  USED ON CANEBERRIES IN  WASHING-
  TON AND/OR OREGON
   Company Name/
   Registration No.
     Produc; Name
AFC Company;
  037177-6221.
A3-Chcm:
  037730-C343....
Agway:
  008590-Jo	
 AFC Contact Wood
  Killer.
I
! Salvo.
!
I Agw3> Taxi-F-.im
•  Prsmei ^o.
A.H. Marks and        ;
  Company, Ltd.:       .
  015440-1	i
Ansul:               i
  006308-3010	\
  006308-3011	|
  006308-3012	'
  006308-3013	\
  C06308-3914	'
Apollc Enterprises:      I
  013165-13	1
S2irdaRdMcGuir3.fr:.:
  SLN NV-«10005	:
BakerVicId AG:
  0113C9-?775	
  011363-8793	
  SLN CA-780171.
BFC Chemicals:
  045639-113	
 Tecrnical DNS?.

 AncracK Herbia3e
 Ancrick Hertiride
 AncracK Herbrcnie.
 Ancreck Kerj:c,i'e.
 AncracK He.^i~.;:;a.

 Dinitro 3.

 BaWs Con;a:t Weed
   Killer.

 Bic Dir.iiro Wee-j "•' '••:.•.
 Bac Contact V
-------
7376
Federal Roaster  / Vol. 54, No. 32 / Friciny. February 17. 19U9 / Notices
LIST A—PRODUCTS THAT MAY  NOT BE
  USED ON CANEBERRIES IN WASHING-
  TON AND/OR OREGON—Continued
                 LIST A—PRODUCTS THAT MAY NOT BE
                   USED ON CAIOEBERRIES IN  WASHING-
                   TON AN • /OR OREGON—Continued
LIST A—PRODUCTS THAT MAY NOT BE
  USED ON CANEBERRIES IN  WASHING^
  TON AND/OR OREGON—Continued   ™
Cc.rr.caov Nc^o/ ! p ^ , ft
Pi'-..-.. station Nn. i
SLN TM-C-'.CCOI 	
SIM WA-830'.-l5 	
Fc-rrl So.-/:C3:
0'CU1'1-S';C'- 	

F-'i.'C Cs-;isra'.:S!v
c:^::s IE;-! 	
C "J'-i'll-ie59
000273 3SS9 	
"Lf*' VV"i-77Cv-*J 	
010'33-ZS 	
GrilLn:
001812-1 1E 	 - 	
Helena;


CC5905-7W7 	
035905-7588 	
003905-7593
005905-7593 	 - 	
005905-7603 	
005305-7601 	
005^05-7602 	
00=905-7867 	
005905-7888 	 .....
C-35905-7889 	
005905-7890 	
0059C5-7891 	
C3J905-7BG2 	
"'JC3C5-73S3 	
00!:9C5-7S94 	
00!irO=-~on5 	
Hi-Plains:
C3ri965-3007 	
Iu3 Incorporated:
045115-47 	 _ 	
J.R. Simplest Company:
0070C1-4378 	
007CC1-774S 	
01"C02-11
Kaw Valley.
044215-68 	
044215-89 	
044215-90 	
04421 5-125 	
CLN CA-79C013
Landia Chemical
Company:
00&3S9-5G37 	
Larcrhf Incorporated:
OT^i4^-660 	 _ 	
U.r-o Chrm Cor.ipany:
004841-50
M'.cro-Flo:
051035-68 	
A:icr3Ci< ^ll"blClio.
r-.. ;--•-; 0>'- iT./ion
H-lS "-..c.-.-in
R-'fi ^iiii.^.;n.
N'T::.- .Vw-W Coie C.
S !•"•-. G ",CO.
f'r.r va Si-.'.-« P£ Cod-!
16.
S.rrC' rtL3.
rjitc-ra S.r.o» Pi1.:? i^ie
3~1213
Pro'.l G.;r:.-;l WS Pr-->-
m3:go
PICK.! Genera! Weea
Kilier.
PreTierge Cini'jo Weed
Killer.
Spark.
Sp^rk.
Spark.
SporK.
Spark.
Spark.
Spark.
Spark
Spark.
Spark.
Spark.
Spark.
Spark.
Spark.
Spark.
Spark.
Spa'k.
Surge Growth Stimulant
Spa'k.
Spur 440.
Dira'ro 3 Dinitro Weed
Killer.
Contact Weed Killer.
Contact Weed Kiiler.
Sim-Chcm Dinitro Weed
Killer.
Miner Dinitro Weed Killer
Cherrcx General Weed
Killer.
Tide Weed Pre-merge
Type.
Baird's N-D Herbicide.
AGSCO Skin-Set A
Herbicide for Potato
Vine Killing.
Tidn Woed-Asiio Pro-
Emsrge Typo.
Scathe Peanut
Hc.-r.cide.
USS Premergo DiniUo.
Fremerge Dinhro Wc:d
K'Hsr.
Premerge Dinitro W&ed
Killer.
Cc-'-.paiy 'Jarre/
f-TQ'Sfni-or NO
,
(/..ci .Vnrnca ClKm.cal
C-rr.r;any ii1:.:
SLN CA-790227 	
SLNCA-7:02Z3 	
P,i:!lic S.;\"!Y:
OCt '•«-•. 4? 	
Platte Cr.srr.ical:
CV 704-1 76 	

m.i-'"i4-?i1^
03«~04-i45 	
C34704-253
C34704-3860 ...-„ 	
Puregn:
CH1 202-244 	 	 	
SLN CA-?800i3 	 	
SLND-C40013 	
R«t:loff:
0074 ~ 'J-7 	
Rrverside/Teta:
009779-1 	
C09779-188 	
Rockwood:
010226-3751 	 	
Rcyslef Company:
004004-334 	
RusseM Chemical:
011159-7329 	
Santa Paula:
043906-7330 	
SLNCA-760016 	
Schail:
prj34gg_10 . ......
Socurity Lawn:
OOC769-3G5 	 _ 	
S.N.P.E.:
035134-1 	 _ 	
011682-12 	 _ 	
Soil Service:
006973-3597 	
Southern Agric. Ins.:
000829-197 	 _ 	
Staples CW
Incorporated:
001345-4 	 _...„ 	
Stautler
000476-1971 	
Steven Industries:
002459-2 i 3 	
Superior:
003122-7195 	 	
Thempson-Hayward
Chamical Company:
SLN CA-700177 	
Tc\0 Spray DusL Inc.:
SLN CA-790209 	
ProrJi'Ct Name '
Diaitro Cpntsct W*<*1
KiliCi.
Fire^il Dmi; o \Vosa
Killtr.
Oinitrc P E.
Clean Crop DiX:o-GS 3
•Aucd Killer.
Clean Croc Din,;.c ">-B
Herbicide.
C^an Crop Dinr.;o 5--!?
He.-bicioc.
Ciean Crcp Technical
DNi'P.
Clean Crop Contact
Werd Killar.
Qear. Crop Top-Kill.
Puregro Preharves'.
DcsiccanL
Purecro Contact Weed
Kiifer.
Puregro Preharvest
Desiccant.
DNBP-Ss Horbi&de.
Dinitrol.
Brand Prert,ergo.
Rockwood Brand
Dcsic:an;.
Cnem-Pest Diniuo Wesd
Killar.
D>'nr;ox 300.
Russell Chemical
Contact WK.
Santa Paula Chemical
Contact.
Schall Contact Weed
Killer.
Premerge Ointtro Weed
Killer.
Dinoseb.
Sim-Chem Vint Killer.
Super Contact Weed
Kiiler.
Dinitro General Weed
Killer.
Premerge Dinitro.
Dinitro P.E. Weed Killar.
Master Brand Promcrgo
Superior Yellow Top.
Contact Weed Killer.
Toxo Contact Weed
Kilier.
SSa i Pro**,*™
"rans Chomc:
CC'J6lB-13
U'nroyat Ciicrr.ical
Cor,- -an/. Inc.:
*.ri4 00-75 	
•JUO-iCO-103 	
OC«'*/"OC- 133 	
Ot040C-12S 	
OOO-Cv-147 	
CC, 1400- 1 53 	
CCU <00-130
OOP-'-C'J-C -'5 	
(KCMpo-Jos 	
OrjtWu-' >T
SLN AL-E'0026 	
SLN AR-800016.. 	
S' N AR-e40004.
SLN iD-6juoio 	
SLN 1D-63G013 	 	 	
SLN iD-840003 	
SLN ID-040006 	
SLr,' LA-600034 	
SLNMS-8CWM5 	
SLN wo-610021 	
SLN OR-630002 	
SLN OR~e40004 	
SLN 1N-810014



SLN WA-64034S 	 - 	
SLNWA-840046 	
Universal Cooperative:

Valiey Cnemical:
Van Waters and Rojers:
000550-70 	 	
Vartac Chemical:
0395*1-10 	 	 	

03951 i-8" .._ 	
03951 1-C8
039511-89 	
03S511-9" . . ..
03G511-112 	

02^511-115 	 	
C39S11-116 	
039511-6817
039511-6018 	 _.....
039511-6919 	 „ 	
039511-6620 .. . .
C3951 1-6821 	
03351 1 -6822 	 _. 	
03951 1-€923 	
0^95 11 -6824 	

0395 11-602'- 	
03951 1-6B"17
03051 1-6S28 	
039511-6829 	 „ 	
03"51 1-6830 	
03P51 1-6831 	
032511-6832 	
03551 1 -6833 	 	
03951 1-6834 	
039511-6835 	 	
TCI-DN3P
Dyanap.
Dory; (H.W.).
Uni'iyai Dnowb-i.
Un;r:va! Di"os,is-3.
EMy" CNb?.
CMS?.
~H !T"iit-c Technical.
DC Pest:: C .'• !-,•> Vvccii
!'.:!'sr
K "an Krc?
S*iW~A Oi^'TO W'ar."'
Ktl'et.
l,'n;rrya! O'nostb 3.
Un>ro;a: Dir.oseb 3.
Uniroyal Dmoi
-------
Federal Register / Vol. 54,  No. 32 /  Friday, February 17, 19B9 / Notices
7377
LIST A— PRODUCTS THAT MAY NOT BE
«ON CANEBERRIES IN WASHING-
ND/OR OREGON — Continued
^cgSonNo' Pr0dUCt Nam°
035C1 1-6336 	
03D5" 1-6337
fl-a -,•-, -{ja 38

C39511-68.19 	
G3~511-C9':0 	
C;~5l 1-6851 	
Cj';i!i-G3E3 	
.SLN <-L-82D004


SLN CA-82010V
3LN IL-82C020 	
SLN, iri-6"5 0005
SLN VO-820007 	
SLN NC-820004 	
SLN NC-820017 	
SLN VA-620007 	
CLN VA-82n026
\v?slern Farm Service:
0116^6-5767
SLNCA-70C094 	
Wlw-137
White House:
WiiS'jr E.l:3:
002935-353 	
00'935-65°2
C02G35-6593 	
i'02Q3S-45c34
"iD2'535-6636 	
C0'j35-6661 	
SLN CA-7CC004 	
S' N lD-770024
SLN ID-020CC4 	
SLN MT-810021 	
=)LN CR-76C012 . ..
SLN OR-780048

SLN OR-810C44 	
SLN VYA-760013
S1 N WA-770043
cl N WA-800068
SLN V. A-B30025
y.-'l?on Lac and
•any:
0-1
	
Prenerge.
Preme'gc.
Prcmerge.
Premerge.
General Weed K.llcr
Gorvrral Weed K-'-'-x
Gencia! Weed *.:!er.
General Weed Ki'.iii
P'emerge 3 Dinitro
Amino Herb.
Prumerge 3 Dinitro
Amme Herb.
Premerge 3 Dinitro
Amine Herb.
Fremefge 3 Dinitro
Amine Hero.
Premerge 3 Dir..tro
Amine Herb.
Premerge 3 Din:t;o
Amine Hero.
Premerge 3 Dintro
Amine Herb.
Prerr.orge 3 Dinitro
Amine Herb.
Prcmerrje 3 Dinitro
Amine Herb.
Premergo 3 Dinitrg
Amine Hero.
Prcn\erge 3 Dinuro
Amine Horb.
Contact Weed Killer.
Ccr.;act NCS.
WcsWn Fum Soiree
Ccr.tact Wooo S.:i
1 Dow. Gererai Weed
'• K.SIi-r.
: DO.
Dinitro Weoa K'i'v 5
; Do.
1
1 Contact Weed K:i!ef.
1 Owners of dinoseb products previously regis-
tered under FIFRA section 24(c) for use in only one
Slate on any crop other than canebemcs may or
may not be permitted to submit claims/rcqiiosts
dutmi; the first period discussed in Unit II. E., de-
pending on wnetnor tho product also boats gersral
labeling lor use 0:1 one or more caneberry crops. If a
product is registered undsr section 24(c) and doos
not bear any labeling for use on a caneberry crop.
the owrwr may submit a claim during the first tint-
period.
Using th«!se lists, the person filing the
claim should find the productfs) for

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Federal  Register  / Vol. M. No. 32  /  Friday. February 17,
                                                                                       /  Notices
whi..h he/she is claiming .
indemnification und/or requesting
iiisp"sal assislance, and complete the
claim form (including the product
registration number) as described in
Unit II. C.  If the registration number on
thp product label is not present on this
list, and the owner is sure he/she has a
ilinoseb product, he/she should file the
r.ihiir. or request using whatever number
is present  on the lubel. The absence of a
product registration number may be
explained  by a registration transfer from
•jne company to another. In such a case.
the new registration legally
encompasses ail forracr :vgist rations
tind, as long as the- registration was
transferred to another company and was
subsequently suspended and cancelled
under section C(c) cf FIFKA, tlie owner
may be  entitled to an indemnity
payment and/or disposal assistance
with respect to that product even though
the product now goes by another EPA
registration number.
C. What Information Must be
Submitted?
1. Claim Form and Supporting
Documentation
  EPA has prepared an updated form for
filing claims/requests ond  an instruction
sheet to accompany it. The form and
instructions distributed in conjunction
with the April 15,1987 Notice have been
revised  to  reflect chan«( s in the
eligibility and labeling of certain
products that have occurred since tlie
April 15,1937 Notice. The revised
materials can be obtained  from the EPA
regional offices listed in Unit n. D. of
this Notice.
  It is the  responsibility of the person
submitting an indemnity claim to submit
the required documentation to support
the claim. The insr  • ions
accompanying the -j.-i-n form indicate
what type  of supporting documentation
is acceptable for each element of the
claim. For  example, all individuals filing
claims must subm:1 evidence of the cost
to the claimant in either producing or
acquiring the product. The  cost is .
limited to the direct cost of the product
and does not include such  incidental
items as transport or storage costs. For
registrants/manufacturers  holding
inventorir.- of a labeled and packaged
product ti.at could not be sold,
production records showing cost of
production, or invoices showing the
purchase cost will be acceptable.
Distribute:::., wholesaijrs, retailers, and
users should submit purchase invoices.
tjurchasp receipts, or notarized
r.ffiviavits.
  If disposal or reprocessing has elrnady
occi'p-ed. evidence of legal dirposal is
                    also required. Records to be used as
                    such evidence should be kept in
                    sufficient detail so tlint EPA could track
                    the history of indiviriu:;! dinoseb
                    products for which indemnification is
                    being sought. Such evidence must
                    include invrices or waste manifests
                    from facilities permitted to handle
                    dinosc'b wastes. In such a case,
                    indemnity payments may be granted for
                    the cost of the product but not for the
                    cost of disposal or reprocessing.
                      The form also provides a way to
                    request disposal of a product, whether
                    or not indemnification is requested. All
                    information requested on the form
                    regarding quantity, unit number and
                    size, and Oihur facts pertinent to
                    disposing of excess product must be
                    submitted in order for the product to be
                    eligible for Federal disposal.
                      A claimant is not entitled to an
                    indemnity payment for a dinoacb
                    product for which he/she has already
                    recovered losses through sale or use. If
                    an owner of a dinoseb product has  sold
                    or used any existing stocks (for
                    example, for use consistent with the
                    Final Cancellation Order, for other
                    lawful uses during past use seasons, for
                    a non-pesticidal purpose, for use in
                    another country, or other purposes), the
                    owner must reflect the effect of this sale
                    or use in completing the claim form,
                    since it will lower the amount of
                    indemnification for which he/she is
                    eligible. Any claim against the Federal
                    government must be offset by the
                    amount received from sale or use of the
                    dinoseb product because tlie owner has
                    eliminated those "losses" he/she might
                    otherwise have sustained as a result of
                    suspension and cancellation of that
                    amount of product.
                      Any person submitting a claim as a
                    legal representative of another person
                    must submit evidence which establishes
                    his/her authority to file the claim and
                    receive payment in satisfaction of the
                    claim on behalf of the owner of the
                    product. A person submitting a claim as
                    an assignee must submit evidence of
                    assignment of the claim  and
                    demonstrate that such assignment
                    occurred as part of a recall of the
                    products in question.
                      If at any time a claimant decides  to
                    withdraw a claim and/or request, he/
                    she must certify in writing that the
                    product has been properly disposed of;
                    lawfully sold, distributed, or used in
                    accordance with the  Cancellation Order.
                    emergency exemptions, or the
                    injunctions by the District Court of
                    Oregon; recycled; or exported.
                    2. Business Records Verification
                      Manufacturers, registrants,
                    distributors, end any other claimants
tilr
that normally maintain business records
are permitted to consolidate the
supporting information required to
accompany the claim form and to x <
the contents of the claim by submitti^
an auditor's report or a schedule
supported by an independent certified
accountant's statement verifying the
validity of the schedule. Each clement of
the claim, sucli as cost per unit of
product or quantity of product owned at
the time of suspension, musl bo
reviewed and verified by the
independent auditor if verification fur
the complete contents of the claim is
being provided throuph the report or
statement. If the independent review is
being conducted for only one clement uf
the claim, such as a manufacturer's cust
of production per unit of product.
supporting documentation must be
submitted for all other elemnnts of the
claim. EPA retains the right to request
submission of the information that
formed the basis for the audits or
reports in  order to verify the validity of
the information submitted.

3. Composite Claim Lists

  Registrants or suppliers who have
recalled a product from their customers
and who are assignees or
representatives of those customers may
submit composite lists for separate
elements of the claim form identifyi
the product, product owner, qu:intiti
-------
                Federal Register /  Vol.  54,  No. 32  /  tnaay,
  .1 h assertions of cor.fidenttalily of
  :,s information must be supported
   .mentation of the reasons why
  ure of^^nformation is likely to
  .-jbstH^Kiarm to the
  •:i?ive pBPlon of the business.
  formation covered by the
  j.-i will be disclosed by EPA only
  •-.'xr.t allowed by FIFRA section
  ; I-Y means of the procedures set
  -. 4.".. CFR Part 2. If no such
  o;; and supports documentation
  •::any the information when it is
  .d by EPA, il T.UV be made
 .•j'.o 10 the public by EPA without
  • notice to the business (S«e 40
 :.2C.?(.'.}(2)). EPA has determined
  \-.:-\\ not aiford confidential
 :•';:.: to certain information
 •^ti'd on the claim form because it
 ju disclosed to contractors to
 .•;e for disposal of the dinosfib
  :Jcs. Confidentiality claims should
 • applied to: th: type, composition.
 •jdr.lily of pesticide product, the
 i::e cf containers, and the product's
 , jn. If EPA receives any
 :.:niiality clain:s for this
  .:!ion. the claim for
 ::r.;fication and/or request for
 •sjl will not be considered and will
       to the claimant.
'.'. Investigations
\\ rvlans to conduct randurti
         of clairns/reoupats
          e purpose of
          :ir veracity. In verifying
          s, EPA mny seek to enter
 iif:s lo examine any dinosub
 •"iiiu products being stored pending
 -sa! to asiiii': tiiat they are being
 ! appropriatniv [i.e.. in
 •.,-.;:. .nee wi;h tb.o regulations and
 'lines described in Unit III.), to
 line records rili-vunl to the claim,
 convict whatever other
 .:.:::itio:is are nncrssary to audit the
 - ! ;..iirr.unt or authorized
••-i'.'.ijlive must s>ia:i the claim form.
  .-j :hn iorn\ constuutes agreement

 ! ;..;•. ail s'u't.'.nier'.ls made and
••:. :'.ion provided in the claim arc
 -. id  cnrieut to the best of the
-. 
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 7380
Federal  Register /"Vol. 54, No. 32  / Friday. February 17, 1989 /  Notices
  EPA is not accepting claims/requests
for products that can be used on
canebcrries until after the 1989 season
because it would be unable to compute
the losses suffered by owners until these
opportunities for sale and use of the
products have expired. Therefore,
UWIILTS of products that can legally be
used on cancberrii/s should not submit
claims and/or requests for disposal until
the beginning of ihe second time period.
  The first time period extends from
February 17,1939 to June 19,1939.
O'.vnera of ilinoseb products which may
rot be used on caneberries in
Washington and Oregon must submit
chnr.'s for indemnification and requests
for cl.'spissiil assistance during this
period. The second time period extends
from June 15,1989 to August 15,1909.
and owners of dinoseb products which
may be used on caneberries in
Washington and Oregon daring the 1989
use season must submit claims for
indemnification and requests for
disposal assistance during this second
time period. Unit II. B. of this Notice lists
productr, according to whether or not
they are labeled for use on canebcrrins.
  Claims submitted by owners of
products that were eligible for
indemnification at the time of the April
15,1967 Notice but which may be used
on caneberries in Washington and/or
Oregon will not be processed until after
June 15,1939.
  As explained previously, EPA will be
contacting all people who submitted
information on their dinoseb products,
but whose products were ineligible at
the time of the April 15,1987 Notice. If
none of the information has changed, the
owners will be able to affirm the
information in their prior submission
and formally submit their claims/
requests by returning a signed summary
claim sheet and certification form during
the first cr second time period,
depending on whether their products
may be used on caneberries.
  In addition, EPA has decided to afford
owners of products eligible at the time
of the April 15,1987 Notice but who
failed to submit a claim and/or request
for disposal assistance in response to
the April 15,1987 Notice, a second
opportunity to do so now. These people
should determine whether their product
may be used on caneberries, and thus
whether to respond during the first or
second period. All claims/requests must
be submitted by August 15,19G9. All
claims/requests received after August
15,1939 will be denied. EPA does not
plan to provide another opportunity to
file or submit claims for indemnification
or requests for disposal assistance for
dinoseb stocks.
                      If a ckiim/rnqucst is filed within the
                    prescribfid time period, but EPA
                    requests supporting documentation not
                    included with the original claim/request.
                    an appntyrialc pi;riod will be allowed
                    for ::!bmis:;ion of the additional
                    inform.-ition required for consideration
                    of the claim/request.
                      A cldim/requcst may be amended at
                    any time before final action by EPA. Ali
                    amendments must be submitted in
                    writing and signed by the claimant or
                    his/her authorized agent or legal
                    representative.
                      Further, in order to expedite the
                    disposal of dinoseb products. EPA
                    requests persons who will be submitting
                    requests for disposal assistance during
                    the time period June 15,1939 through
                    August 15,1989, but who have not yet
                    submitted information or a request for
                    disposal assistance to so notify EPA
                    Headquarters disposal staff immediately
                    by telephone (1-800-DIN-OSEB (in
                    Maryland call 1-800-331-3704)).

                    F. How Will Claims be Processed?
                      Upon receipt of a claim, EPA will
                    assign it a claim number and all
                    correspondence regarding the claim will
                    reference that number. All claimants
                    will be notified of any additional
                    information or verification required for
                    consideration of the claim. If a claimant
                    is unable to provide the documentation
                    required for consideration of his/her
                    claim within the prescribed lime period,
                    the claim will be denied. EPA plans to
                    conduct random audits of claims,
                    including field inspections, and may
                    reject claims if investigators are not
                    permitted to enter the claimant's
                    premises or are otherwise impeded in
                    conducting an audit.
                      EPA's determinations regarding
                    eligibility of claims and amounts of
                    indemnity payable shall be
                    administratively final.
                    HI. Interim Storage, Transportation And
                    Disposal of Dinoseb Stocks
                      EPA encourages all registrants and
                    manufacturers that are capable of
                    recalling or reprocessing their dinoseb
                    pesticide products to do so. However, if
                    the product is reprocessed, the amount
                    of indemnity to which that person is
                    entitled may be effected.
                      EPA has awarded contracts to two
                    waste management firms for the
                    disposal of dinoseb. It is the
                    responsibility of the holders to handle
                    and store the material safely. Th?
                    conditions required for proper handling
                    of dinoseb pesticides may be governed
                    by FIFRA or the Resource Conservation
                    and Recovery Act (RCRA), as well as by
                    pertinent state and local laws end
                    requirements. The determination of
whether FIFRA or RCRA applies
depends on the intent of the holdor (i|
40 CFR 2(31.^(H)!2)(i) and 261.33, 40
U37 (Jan. 24.1985)). Simply stated, if
unused dinoseb pesticide  storks ure
being held with the intnnt of legally
using, recycling, selling, or distribute.;.:
them, then thoy may still be considered
pesticide products  and should be stored
in accordance with FIFRA. However.
cnce the stocks are being  held with the
clear intent of disposing of them, then
they may be considered solid or
hazardous wastes and must be stored
transported, and disposed of in
accordance with RCRA and any other
applicable laws and regulations
governing wastes. The procedures for
handling, storing, and disposing 01
dinoseb under FIFRA and RCRA are
described in more detail in the following
units.

A. Interim Storage

  In general, the FIFRA procedures for
storage described in 40 CFR 165.10
recommend that the material be stored
on pallets or similar raised platforms in
a dry, well-ventilated, and separate
room, building, or covered area with a
concrete floor, where fire protection is
provided. Movement or handling should
be kept to an absolute minimum.
  Containers should be stored with tl
label plainly visible. Containers shuul?
be checked regularly for corrosion and
leaks. If a dinoseb container is found to
be leaking or damaged, the container
should be transferred to a sound,
suitable, larger container (preferably a
steel salvage drum) and the overpack
container should be properly relabeled.
Alternately, the contents of the damaged
container may be transferred to e new
container (i.e., repackaged) and then
properly labeled. Before repackaging
however, the owner/holder should
contact the appropriate EPA regional
office to learn of any applicable St.iti? or
local requirements. Over-packing or
repackaging will not generally
jeopardize the award of a claimant's
indemnity payment, provided that the
claimant or holder adequately
documents such repackaging and the
outside of the package is clearly marked
with information to identify the
contents. Additional guidance is
provided in a short document on
overpacking and repackaging dinos«b,
available from the pesticide disposal
staff at EPA headquarters (I-BOO-DIX-
OSEB (in Maryland call 1-800-331-
3704)).
  However, if a person is  holding
unused stocks  with the clear intent
disposing of the stocks, he/she must
comply with the requirements under
DU1U





U^

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                    Federal Register  /  Vol. 54, No.  32 / Friday,  February 17, 1909  /  Notices
                                                                                                                 73G1
CFR
          jf RCRA as specified in 40
             ' 261 through 266, and 270.
          urements may differ from the
•iiorage requirements of F1FRA.
Additionally, a storage permit may be
•r.q-ir-c! (See -:0 CFR 270.13 through
r.v. is).
  In ;.:an-.-;'al, the dinosub storage are. a;::ho:izj!ion Act of 1985 (SARA).
  El'1 A may perform inspections of
::-.ii;:ri.i!s in  storage to determine if the
above conditions have been n:et. Further
ifchnic;ii advice may be obtained from
•.'-.c JIPA regional office contacts listed in
; >i!t ". D of this Notice. In addition,
:.-'";/r:r,ii'.inn on tha storage provisions
_:::i:ir FiFSA are available from the
•j.isticiue disposal staff at EPA
•|<;:.rh;u:'.n-?n; st 1-800-DIN-OSEB (in
M;'.:-v!;:rid  rail l-COO-331-3704). and on
•.•.(.: r.'->r;!.c;c requirements under RCRA
!rj::i '.':>.•! RCRA Hotline at 1-600-424-
 340 or !:'.P2) 3.12-3000.
B, Disposal
  Disposal of certain unused n jstici Je
products may be subject to regula!::)ii as
hazardous  waste under RCRA. Ur.dnr
the existing hazardous waste rules.
unused dinoseb. product that has
become a "waste" is regulaioJ w!ii-n
dii.-arded in commercial gradu,
trJ-nical grade, or off-spucificiitiun fo:-:'
f,r if dinoi-'ab is the sole active ingredient
in the furrnulation (hazardous wcsie
designation "Po:o") (Sec 40 CFR
2C1.33(e)). Discarded formulations
containing dinoseb as one of ft number
of a:tive ingredients are presently not
considered to be hazardous wastes
unless they exhibit a characteristic of
hazardous waste. A formulation is
considered hazardous if it has one or
more cf the following characteristics:
  1. It is  easily combustible.
  2. It dissolves metals or other
materials, or burns the skin.
  3. It shows Extraction Procedure
to.\icity (coniains hi^h concentrations of
heavy metals or specific pesticides that
could be released into ground waier).
  4. It is  unstable or undergoes rapid or
violent chemical reaction with water or
ether materials. (See 40 CFR 201.20
through 201.24 for additional information
about these characteristics).
  Persons accumulating or possusbirifj
dinostib in  less than the quantities
specified in thsse regulations (1
kilogram or about 2 pounds per  munth)
may be conditionally exempt frcrr.
RCRA regulation. However, State
hazardous waste storage and disposal
requirements may still  apply.
  Under the hazardous waste rules,
empty containers with  minimal  dincseb
residues as defined in 40 CFR 201.7 are
exempt from regulation under RCRA.
Specifically, containers that once
contained dinoseb are considered to be
empty if they are triple-rinsed with an
appropriate solvent (or cleaned by a
method of equivalent effectiveness) nr
the container's inner liner has been
removed [See 40 CFR 261.7(b)(3)l.
However, the rinsate that  is generated
from this operation may be considered a
hazardous  waste under RCRA and must
be managed in accordance with the
appropriate management standards
unless the person conducting the
operation is a farmer. Specifically, a    j'
 farnif-r disposing of such rinsate fmm a
 (Jinusub container that was used on his/
 linr (nvn farm is not subject to regulation
 under RCRA for those wastes provided
 he/she triple rinbjs each emptied
 din;;.;cb -ju.'itainnr t;nd disposes of the
 cki.-. .-;'.• residues on his/her own farm in
 a ma::r> Assiilunt Administrate?, Officu uf
 Pv"iti\:i{li'S unri. Toxic Suhstancns.
 |FR Doc. 8sr-?017 Filed 2-1fr-89: B:45 am|
i BILLING CODE 6560-SO-M

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                Federal  Register  /  Vol. 54,  No. 30 / Wednesday,  February 15. 1989 /  Notices
                                                                                                            7027
3iotec,
in Re
 OPTS-00049D; FRL-3522-2]

          B9V; Request (or Comment /
          |ry Approach           • '
 \GENCY: Environmental Protection
 Agency (EPA).
 \CTICN: Notice.

 SUMMARY: EPA is soliciting comments
 in the direction of its program under the
 Toxic Substances Control Act (TSCA) to
 insure  that products of biotechnology
 ire tested, manufactured, processed,
 '.nd used in a manner that docs not
 Dresent an unreasonable risk of injury to
 >.uman health and the environment. This
 • otice does not change the Policy which
 was published in the JUT.G 26, 1989
 Federal Register (51 FR 23313). EPA has
 jeen developing a proposed rule to
 address matters discussed in that policy
 •tateir.ent of the regulations of certain
 products of biotechnology under TSCA.
 Juring  this process comments have been
 received from cur own  science advisory
 committees and ether Federal agencies.
A number of issues have arisen and EPA
is requesting comment  on several issues.
Commenters are requested to review the
 issues in this notice and provide their
comments.
OATES: Written comments should be
 submitted by May 16. 1989.
 AODRM^Commer.ts en issues raised in
 ihis n^BBmust bear the docket control
 nunblTOPTS-000''OC, and must be
 submitted to the following address:
TSCA Document Processing Center (TS-
 790), Office of Toxic Substances,
 Environmental Protection Agency, Room
 L-100. 401 M Street SW., Washington,
 DC, 204SO.
  A docket will be available for public
 inspection in the TSCA Public Docket
 Office, Room NE-G304, at EPA
 Headquarters. 401 M Street SW..
 Washington, DC, from  6:00 a.m. to 4
 p.m., Monday through Friday, except
 legal holidays. The docket includes all
 documents relevant to  the issues raised
 in this Notice and will  contain all public
 comments that are received. These
 thicv.ments containing confidential
 business information will be placed in a
 separate, confidential file.
 FCR FURTHER INFORMATION CONTACT:
 Michael M. Stahl, Director, TSCA
 Assistance Office (TS-799), Office of
 Toxic Substances, Environmental
 Protection Agency, Room ED-44, 401 M
 Slreut SW., Washington. DC.. 20400. In
 ihr USA: (202) 554-1404. TDD: (202) 554-
               INFORMATION:
I. Background
        tcmber 31. 1984. the 'White
House Office of Science and Technology
Policy issued in the Federal Register a
"Proposal for a Coordinated Framework
for Regulation of Biotechnology" (49 FR
50880, December 31.1984). In that
proposal, EPA stated that the definition
of "chemical substance" under section
3(2) of TSCA includes all
microorganisms except those excluded
from TSCA jurisdiction (i.e., those
microorganisms manufactured,
processed or distributed in commerce
for use as pesticides, foods, food
additives, drugs, cosmetics, or other
related items are excluded).
  After rRviexving comments on the 1384
Proposal, ETA issued in 1986, as part of
the "Coordinated Framework for
Regulation of Biotechnology" (51 FR
23313, June 26.1986), a "Statement of
Policy" describing how EPA was
addressing certain microbial products of
biotechnology under TSCA. In the 1986
Policy, EPA interpreted the new
chemical substance premanufacture
notification (PMN) provisions of TSCA
section 5 to cover new (inter-generic)
microorganisms used for commercial
purposes. This  interpretation became
effective immediately. EPA also
requested voluntary submission of other
information until final rules were in
place, and described its intentions to
develop, under TSCA, a significant new
use rule for pathogenic microorganisms;
a rule modifying \hs PMN research and
development exemption so that small
scale field testing of microorganisms for
TSCA purposes is subject  to PMN; a
section 8(a) reporting rule  for other
microorganisms prior to release in the
environment; and section 5(h)(4)
exemptions as  appropriate.
  In developing a regulatory framework
to implement the 1986 policy statement,
EPA received advice and a "concept
paper" from other federal  agencies, as
well as unsolicited suggestions from
some nongovernmental organizations.
EPA discussed proposals with the
interagency biotechnology Science
Coordinating Committee (BSCC) and
received its comments. On December 21,
1988, EPA convened a public meeting of
the Subcommittee on the Proposed
Biotechnology  Rule under TSCA of the
EPA Biotechnology Science Advisory
Committee (BSAC), EPA's independent
science advisory group. A draft
proposed rule was provided to the
Subcommittee. This group was asked to
examine scientific issues associated
wilh EPA's approach, as well as the
utility of using groups of independent
exports to determine whether research
and development (R&D) proposals
should be exempt from the
premanufacture notification
requirements of section 5 of TSCA.
Several members of the public requested
and received permission to address the
Subcommittee. Included among the
commenters was the Chairperson of the
BSCC who described inter-agency
discussions over the  proposed TSCA
ru'cmaking.
  A number of basic issues have arisen
during the course of the development of
a proposed rule which EPA has
concluded need to be addressed before
a specific rule is developed and
proposed.
  These include:
  1. What should be  the scope yf the
microorganisms subject to EPA's
review?
  2. What should be  the scope of EPA's
review of R&D activities involving
release of microorganisms to the
environment?
  3. Since TSCA only allows EPA to
review those microorganisms developed
for "commercial purposes", how broadly
or narrowly thould EPA define
"commercial purposes" in the context of
research conducted at educational and
research facilities?
  4. If the definitions of "release to the
environment" and "contained facility"
are to be used to determine whether
there is EPA review of specific uses of
microorganisms, how should these terms
be defined? To what extent should EPA
rely on the definition of "con.teintd
facility" fcund in the guidelines of ths
National Instates of Health [X1HJ?
  5. To what extent should EPA
establish independent expert review
groups (i.e.. Environmental Bios:ifety
Committees (EECs)). similar to the N!U
Institutional Eiosafety Committees
(IBCs), to assist in the review of
potential environmental releases of
microorganisms? What should be the
scope of review by those groups?
  To aid EPA in addressing thess  issues,
this notice requests comment on them
from all interested persons. For
commenteni who wish additional
information txncerning the background
for these issues, m&iorials in th^ public
docket are available on request from the
address in FOR FURTHGH INFORMATION
CONTACT. These include: letters from
other Federal agencios commrr.tmg on
the draft approach, the
recommendations of the BSAC
Subcommittee on the Proposed
Biotechnology Rule under TSCA
following their December 21.1SP.8
meeting, the draft proposed rule they
discussed at that meeting, and the
comments of the members of ih'j public
and the BSCC chairperson at the BSAC

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7020            Federal  Register / Vol. 54, No.  30 / Wednesday. February 15. 1969  / Notices

Subcommittee meeting. All other          comments on a proposed regulatory         Dated: February 3,1909.           ~~
information in the docket is available in    approach for the products of              John A. Moore,
the TSCA public docket Office at the       biotechnology under the Federal          Acting Administrator.
address in ADDRESSES.                   Insecticide. Fungicide, and Rodenticide    [pg Doc- 89-3820 Filed 2-14-89: 8.45 am]
  Elsewhere in this Federal Register a      Act.                                    BILLING CODE txo-to-u
similar notice appears soliciting

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 7025
Federal Register  /  Vol.  54, No. 30 / Wednesday,  February  15. 1909 / Notices
^ENVIRONMENTAL PROTECTION
•VGENCY                        j

 IOPP-50663; FRL-3522-3]

 Microbial Pest'cides; Request for
 Comment on Regulatory Approach

 AGENCY: Environmental Protection
 A;:ency (EPA).

 ACTION: Notice.
 SUMMARY: EPA is soliciting comments
 on issues that have arisen in the
 development of an amendment to its
 Experimental Use Permit (EUP)
 regulations under the Federal
 Insecticide. Fungicide, and Rodenticide
 Act (Fir RA). The amendment would
 require notification before initiation of
 small-scale testing of certain genetically
 modified rr.icrobial pesticides. Each
 notification will be reviewed by EPA
 and a determination made as to whether
 en EUP will be required. This
 notification scheme is intended  to
 provide sufficient oversight of the early
 testing of these microbial pesticides to
 mitigate any adverse human health or
 environmental effects. During the
 development of a draft proposed
 regulation, comments have been
 received  from EPA science advisory
 committees and other Federal agencies.
 Comments are now being solicited from
 all interested persons on issues arising
 during the course of development of the
 proposed regulation.
 DATE: Comments identified by the
 docket control number (OPP-50668]
 must be received on or before May 16.
 1989.
 ADDRESS:
 Written comments by mail to: Public
   Information Branch, Field Operations
   Division (TS-787C). Environmental
   Protection Agency. 401 M Street SW..
   Washington, DC 20460
 In person, bring comments to: Room 246,
   CM £2,1921 Jefferson Davis Highway
   Arlington, VA 22202.
 FOR  FURTHER INFORMATION CONTACT:
 Frederick Betz, Science Integration and
 Policy Staff. Environmental Fate and
 Effects Division (TS-769C),
 Environmental Protection Agency, 401M
 Street SW., Washington, DC 20460. (703-
 557-9307).
    A public docket has been established
 and will be available for public
 inspection at the Virginia address given
 above from 8 a.m. to 4 p.m., Monday
 through Friday, except legal holidays.
 Comments received in response to this
 Notice, except those containing
 confidential business information, will
 be included in the  public docket.
                      SUPPLEMENTARY INFORMATION:
                      I. Introduction
                        Section 5 of FiFRA, 7 U.S.C. 136 et
                      siq.. and 40 CFR 172.2 provide for
                      issuance by EPA of EUPs for the testing
                      of new pesticides or new uses of
                      existing pesticides. Such permits are
                      generally issued for large-scale testing
                      of pesticides involving terrestrial
                      application to more than ten acres of
                      aquatic application to more than one
                      acre. It has been generally presumed
                      that smaller experiments would not
                      require EUPs. However, EPA recognizes
                      that small-scale studies with some
                      microbial pesticides that have been
                      genetically modified may raise many of
                      the same concerns as more extensive
                      uses of conventional pesticides.
                      Accordingly, EPA is in the process of
                      modifying its existing regulatory
                      program to address these concerns.

                      II. Background
                        Based on the conclusion that there is a
                      need to evaluate small-scale testa of
                      certain microbial pesticides prior  to
                      their release in the environment, EPA
                      issued its "Interim Policy on Small-Scale
                      Field Testing of Genetically Altered and
                      Nonindigenous Microbial Pesticides" (49
                      FR 40659, October 17,1984). This policy
                      staled that the 40 CFR Part 172
                      presumption would not automatically
                      apply for certain.microbial pesticide
                      products and that EPA should be
                      notified before initiation of any such
                      small-scale testing in order to determine
                      whether an EUP would be required. The
                      Interim Policy was subsequently
                      republished for review and comment in
                      December 1984 in conjunction wiLh the
                      "Proposal for a Coordinated Framework
                      for Regulation of Biotechnology" (49 FR
                      50880, December 31,1984) issued by the
                      Office of Science and Technology
                      Policy.
                        After reviewing the public comments
                      on the 1984 Proposal, in June 1983. EPA
                      published a final policy statement
                      entitled "Applicability of the Federal
                      Insecticide, Fungicide, and Rodenn'cide
                      Act (FIFRA) to Microbial Products" as
                      part of the Office of Science and
                      Technology Policy's Coordinated
                      Framework for Regulation of
                      Biotechnology (51 FR 23313, June  26.
                      1986). The 1986 Policy stated EPA's
                      concern about the potential risks
                      associated with small-scale testing of
                      certain microbial pesticides. To address
                      these potential risks, the Policy specified
                      that EPA be notified  prior to initiation of
                      small-scale testing of all nonindigenous
                      and genetically modified microbial
                      pesticides. The notification allows EPA
                      to make a determination as to whether
                      the test should be carried out under an
EUP. In addition, the 1986 Policy set
forth EPA's plan for future rulemaking to
codify the interpretation set out in the
Policy Statement.
  EPA received public comment on the
1986 Policy and began to revise the
existing Part 172 EUP rule to incorporate
the major elements of the Policy. In the
summer of 1988, the Agency provided a
draft of the proposed rule to Congress,
the U.S. Department of Agriculture
(USDA) and the U.S. Food and Drug
Administration. In November 100R. a
revised draft was reviewed and
commented on at a public meeting of a
Subpanel of the FIFRA Scientific "
Advisory Panel (SAP Subpanel). The
SAP Subpanel and Federal agencies
provided written comments.
  A number of issues have arisen during
the course of the development of this
regulation which EPA has concluded
need to be addressed before a rule is
proposed, including: (1) Scope of
genetically modified microbial
pesticides subject to notification; (2)
Review of nonindigenous microbial
pesticides at small-scale; (3)
Establishment of independent expert
review groups (Environmental Biosafety
Committees) patterned after the
National Institutes of Health's
Institutional Biosafety Committees. To
aid EPA in addressing these issues, this
Notice requests comment on them from
all interested parties to help facilitate
development of the rule.
   For commenters who wish additional
information concerning the background
for these issues, materials in the public
docket arc available on the request,
including the recommendations of the
SAP Subpanel following their November
22,19B8  meeting, the draft regulation
discussed at that meeting, comments
received from the public and ether
Federal  agencies on the draft proposed
regulation, the transcript from the EPA
Biotechnology Scientific Advisory
Committee's January 12,1989 meeting
where a recommendation regarding the
FIFRA proposal was adopted, and EPA's
most recent draft which includes
responses to the SAP Subpanel
recommendations and many of the
 comments received to date.
   Elsewhere in this Federal Register, a
 notice appears soliciting comments on
 regulatory approaches being considered
 for products of biotechnology under the
 Toxic Substances Control Act.
   Dated: February 3,1989.
 John A. Moore,
 Acting Administrator.
 [FR Doc. 89-3619 Filed 2-14-89; 8:45 am]
 BILLING CODE 
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691S    Federal Register / Vol. 54, No.  30 / Wednesday,  February 15.  1989 / Rules and  Regulations
         Commodities
Pcctspef
 million
Cabbage..
     1.0
jrR Dnc. GC-31C2 Filed 2-14-C9; E:45 am]
e:—me core tsso-so-M


40 CFR PART 180

tPP 7E34C4/R100S; FRL-3318-7J

Pesticide Tolerance for Prometryn

AGENCY: Environmental Protection
Agency (EPA).
ACTION: Find rule.

SUMMARY: Tnis rule establishes a
tolerance for residues of the herbicide
prometryn in or on the raw agricultural
commodity dill. The Interregional
Research Project No. 4 (IR-4) petitioned
for this tolerance.
EFFECTIVE DATE: February 15,1989.
ADDRESS: Written objections, identified
by the document control number, [PP
7E3454/R1005], may be submitted to:
Hearing Clerk (A-110), Environmental
Protection Agency, Rm. 3708,401 M
Street S\V., Washington, DC 20460.
FOR FURTHER INFORMATION CONTACT By
mail:
Hoyt Jamerson, Emergency Response
  and Minor Use Section (TS-767C),
  Registration Division (TS-767C),
  Environmental Protection Agency, 401
  M Street SW.. Washington, DC 20450.
Office location end talephone number:
  Rm. 716, CM *2.1921 Jefferson Davis
  Highway. Arlington, VA 22202. (703)-
  557-2310.
SUPPLEMENTARY INFORMATION: EPA
issued a proposed rule, published in the
Federal Register of December 12,1988
(53 FR 50262), in which it was
announced that the Interregional
Research Project No. 4 (IR-4), New
Jersey Agricultural Experiment Station.
P.O. Box 231. Rutgers University, New
Brunswick, N] 08903, had submitted
pesticide petition 7E3464 to EPA on
behalf of Dr. Robert H. Kupelian,
National Director, IR-4 Project, and the
Agricultural Experiment Station of
Californi3.
  The petition requested that the
Administrator, pursuant to section
40B(e) of the Federal Food, Drug, and
Cosmetic Act, propose the
establishment of a tolerance for the
residues of the herbicide prometiyn (2.4-
bir(isopropylamino)-6-methylthio-s-
triazine) in or on the raw agricultural
commodity dill at 0.25 part per million
(ppm). The petition was later amended
to propose c tolerance of 0.3 ppm.
  The petitioner proposed that this use
of prometryn on dill be limited to use in
California base on the geographical
'representation of the residue data
submitted. Additional residue data will
be required to expand the area of usage.
Persons seeking geographically broader
registration should contact the Agency's
Registration Division at the address
provided abcve.
  There were no comments or requests
for referral to an advisory committee
received in response to the proposed
rule.
  The data submitted in the petition and
all other relevant material have been
evaluated and discussed in the proposed
rule. Based on the data and information
considered, the Agency concludes that
the tolerance will protect the public
health. Therefore, the tolerance is
established as set forth below.
  Any person adversely affected by this
regulation may, within 30 days after
publication cf this document in the
Federal Register, file written objections
with the Hearing Clerk, at the address
given above. Such objections should
specify the provisions of the regulation
deemed objectionable and the grounds
for the objections. A hearing will be
granted if the objections are supported
by grounds legally sufficient to justify
the relief sought.
  The Office of Management and Budget
has exempted this rale from the
requirements of section 3 of Executive
Order 12201.
  Pursuant to the requirements of the
Regidatory Flexibility Act (Pub. L 96-
354.94 Slat. 1164. 5 L'.S.C. 601-512). the
Administrator has determined that
regulations establishing new tolerances
or raising tolerance levels or
establishing exemptions from tolerance
requirements do not have a significant
economic impact on a substantial
number cf small entities. A certification
statement 10 tiiis effect was published in
the Federal Register of May 4,1981 (46
FR 24550).
List of Subjects in 40 CFR Part 180
   Administrative practice and
procedure. Agricultural commodities.
Pesticides and pests, Reporting and
recorckeeping requirements.
  Dated: January 27.19£0.
Douglas D. Carapt,
Director. Office of Pesticide Prr-rams.
   Therefore. 40 CFR Part 180 is
emended as follows:

PART 130—[AMENDED]

   1. The authority citation for Part 180
continues to read as follows:
  Authority: 21 U.S.C. 34Ga.

  2. Section 180.222 is amended by
dusiyr.-.ting the current paragraph and
list of tolerances as paragraph (n) and
by adding new paragraph (b), to read as
follows:

§ 180.222  Prometryn; tolerances for
residues.
•    *    *     «   *

  (b) Tolerances with regional
repi^lvation, as defined in § l?n.i[n], arc-
established for residues of the hc.bicidr>
promctryn (2,4-bis(isopropy!arnino-G-
methylthio-s-triazinc) in or on the
following raw agricultural community:
                                                           Commodity
                             Parti per
                              million
                                                  Dill	
                                                                                    0.3
                                                  [FR Doc. 89-3193 Filed 2-14-89: 8:45 am]
                                                  BILLING CODE 6560-50-11                    f
                                                  	i

                                                  40 CFR Part 704                     1

                                                  [OPTS-62013D; FRL-3520-5]

                                                  Comprehensive Assessment
                                                  Information Rule; Extension of
                                                  Notification and Reporting Deadlines

                                                  AGENCY: Environmental Protection
                                                  Agency (EPA).
                                                  ACTION: Final rule; extension of
                                                  notification and reporting deadlines.

                                                  SUMMARY: EPA has received two
                                                  requests for a 60-day extension of either
                                                  the effective date of the Comprehensive
                                                  Assecsment Information Rule (CAIR),
                                                  or, in the alternative, an extension of all
                                                  notification and reporting deadlines for
                                                  the CAIR. EPA has evaluated these
                                                  requests, and has decided to g"">t a 30-
                                                  day extension for all CAIR notification
                                                  and reporting deadlines for the 19
                                                  substances to the CAIR.
                                                  DATES: Tne notification and reporting
                                                  deadlines are extended to the following
                                                  dates:
                                                    1. Submission of a CAIR reporting
                                                  form by manufacturers, importers, and
                                                  processors under § 704.223(a) is
                                                  extended to June 7,1GS9.
                                                    2. Submission of a CAIR reporting
                                                  form by persons %vho process e CAIJl
                                                  listed substance under e tradenamc
                                                  under § 704.223(b) is extended to July 0.
                                                  1989.
                                                    3. Notification of customers who
                                                  process a CAIR listed substance under a
                                                  tradename  under § 704.208(a)(3) is
                                                  extended to April  7,1989.
                                                    4. Submission to EPA of a list of
                                                  tradenames under which a person

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         Federal Register / Vol. 54. No. 30 / Wednesday, February 15. 1989 / Rules and Regulations-    6919
          a CAIR listed substance
                   is extended to
FOR FURTHER INFORMATION CONTACT:
Michael M. Stahl. Director. TSCA
A-jr,:r,tar:ce Office (TS-7S9). Office of
Tc:.ic Suiisiar.ces, Environmental
?ro!?c'.-ic- Aj^r.cy. R.T.. EE-14, 401 M
,'j::ect SW.. VVjihirgtcn, DC :3460.
T.jliphcr:-: (202) 5S4-14P-;, TDD f::)2)
SUPPLEMENTARY W'ORMAT'.CN: EPA
.•isucd .he CAIR (40 CFR Part 704] in the
Federal ?>?gji'.:r of December 22,1S83
(53 FR 51390), iL'dor section 8(3) of the
Toxic Substances Control Act (TSCA).
EPA received tv.-o requests fcr a CO-day
•jx'.cnsion of cither the effective date of
the CAIR, or. i.i ihe alternative, an
extension of all notification and
~eport:ng deadlines To? the CAIR. These
requests were received from the
Na-icna! Point and Coatings Association
(NPCA) and The Society of the Plastics
Ind'jauy (SPI). EFA has ?valuated thesa
requests, and has decided to grant a 30-
cay extension for nil CAIR notification
•••r.d reporting deadlines for the 19
substances subject to the CAIR to the
above  .hies.
  EPA realizes that the extension
t;"r,'gd for the remission of
           i under which a person
          i r. CAIR listed substance
       '704.2C8(a)(l) is extended to a
da;.'; lhat is more than 30 days filter the
orisir.ai r.Mtificatbn dsadlin2 of
Fi-bruary 7,1983. This was necesssry
bcc.:us? the extension requests
subn:itt.:d by NPCA and SPI wers
g:-i-:.nd r.n February 7,1989, and the
public.'.; .ir. uf the Federal Register
^oc-'.rncnt announcing these extensions
v;?.a  rot possible until after February 7.
Therefore, F?A extended this deadline
<.o L'O d.iys after EPA's expected
publication date of this Federal Register
document. Note that the new
poih'icjiion deadline will be March 20,
1^9. even if this date  is more than 30
days ;;f;cr ihe publication date of this
Fetter:-; Rp; istc-r document.
  IndividMii companies may request a
rr-;:;ro:i:i;;lu extension beyond these new
lisjy.l^iis on a substance-by-substance
basis through the mechanisms set forth
in the CAIR. Failure to comply with the
new cx'c-nsion deadline;, or any further
•.?xt!?i:sion deadlines granted by F.PA to
ir'.'i-. i J:;;;! c'jiipa.nies, will constitute a
violation of TSCA section  15(3), and
if.,iy 5:i;,;^ct Ihe violjtcr to the penalties
d.--ii;rii;r.J in TSCA section 16.
           jauts ill 40 CFR Part 704
        ic.'.'s. Environmental protection.
           materials, Reporting «ind
           :ig rjq'jiremeiits.
  Dated: February 8,1989.
Joseph ]. Morenda,
Director. Existing Chesiica! Assessm
Division, Office of Toxic Substances.
[FR Doc. 89-3530 Filed 2-14-39; 3 -45 am]
8IUJNG CODE CHO-50-H
DEPARTMENT OF THE INTERIOR

Bureau of Land Management

43 CFR Public Land Oroer 3708

[03-943-09-4214-10; GP9-064; Ofl-
1M73(WASH), OR-I9854(WASH)]

Partial Revocation of Powersitc
Classifications No. 349 and No. 400:
Washington

AGENCY: Bureau of Land Management,
Interior.
ACTION: Public Land Order.

SUMMARY: This order revokes one
Secretarial order and one U.S.
Geological Survey order insofar as they
affect 153.43 acres of lands withdrawn
for Bureau of Land Management's
powersite purposes. This action will
remove restrictions cr open the lands to
surface entry on 145 acres. Of the
balance which is within Power Project
No. 2145, 3.40 acres remain open subject
to section 24 of the Federal Power  Act
and 5 acres remain closed to surface
entry and mining. All the lands have
been and will remain open to mineral
leasing.
EFFECTIVE DATE: March 10,1989.
FOR FURTHER INFORMATION CONTACT:
Champ Vaughan,  BLM Oregon State
Office, P.O. Box 2965. Portland, Oregon
C7208. 503-231-6905.
  By virtue of the authority vested in the
Secretary of the Interior it is ordered as
follows:
  1. The Secretarial Order dated June
22,1944, which established Powersite
Classification No. 349, is hereby revoked
insofar as it affects the following
described lands:
Willamette Meridian
T. 23 N., R. 23 E.;
  Sec. 26, lots 7 and 8. and MW'ASE'.i.
  The areas described aggregate 113.40 acres
in Chelan and Douglas Counties.
   2. The U.S. Geological Survey Order
dated February 15.1949, which
established Powersite Classification No.
400. is hereby revoked insofar as it
affects the following described land:
Willamette Meridian
T. 23 N.. R. 23 E.:
  SfiC.20. SWUNE'A.
  The area described contains 40 seres in
Douglas County.
  3. The State of Washington has
waived its preference right for public
highway rights-cf-way or material sites
as provided by the Federal Power Act of
June 10.1320, as amended. 16 U.S.C. 818,
  4. That portion of lot 7 inside* the
boundary of Po-.var Project No. 2115
remains cicii-d ,o operation of the
public land laws, including the mining
laws.
  5. That portion cf lot 3 inside the
boundary of Power Project No. 2145 has
been and continues to be open to
operation of the public land laws,
including the mir.irg laws, subject to the
previsions of section 24 of the Federal
Power Act of June 10,1920.
  6. That portion of Lot 8 outside the
boundary of Power Project No. 2145 has
been open to operation of the public
land L=;vs, including the mining laws,
subject to the provisions of section 24 of
the Federal Power Act of June 10,1320,
snd will be relieved of the section 24
restriction at C:00 a.m., on March 10,
1959.
  7. At 8:30 a.m., on March 10,1089, the
land described in paragraphs 1 and 2.
except as provided in paragraphs 4, 5,
end 6. will be open to operation of the
public land laws generally, subject to
valid existing rights, the provisions of
existing withdrawals and reservations,
and to requirements of applicable lav/.
All valid applications received at or
prior to 8:30 a.m., on March 10,1989,
shall be considered as simultaneously
filed at that time. The land has'been and
continues to be open to the mining and
mineral leasing laws.
Rick Ventura,
Assistant Secretary of the Intsrior.
February 3,19E9.
IFR Doc. 83-3489 riled 2-24-89: 8:45 En-,]
EiLUNQ CODE 4310-33-M
                                                                               43 CFR Publis Land Order 6700

                                                                               [AK-932-09-4214-10; F-025943]

                                                                               Modification of Public Land Order No.
                                                                               3708; Transfer of Administrative
                                                                               Jurisdiction From the National
                                                                               Aeronautics and Space Administration
                                                                               to the National Ocsanic and
                                                                               Atmospheric Administration; Alaska

                                                                               AGENCY: Bureau of Land Management,
                                                                               Interior.
                                                                               ACTION: Public Land Order.

                                                                               SUMMARY: This order modifies Public
                                                                               Land Order No. 3708 to transfer
                                                                               jurisdiction of 9.500 acres of land
                                                                               withdrawn for a tracking station near
                                                                               Fairbanks, Alaska, from the National
                                                                               Aeronautics and Space Administration
                                                                               to the National Oceanic and

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^
     c*
       3     UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
       »
      $                 WASHINGTON, D.C. 20460
                                                          OFFICE OF
                                                   PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM

SUBJECT:  Amendment to the Compliance Strategy
          for the Emergency Suspension of Dinoseb

FROM:     A. E. Conroy II, Director         ^>o  /}     .s?
          Office of Compliance Monitoring   Z/^7' fM^rU^^
                                           f] Is V"   \S
TO:       Addressees                      /J
      On March 30, 1987, the Administrator of the Environmental
Protection Agency (EPA) signed a decision to modify his October
7, 1986 Emergency Suspension Order of pesticide products
containing dinoseb.  Pursuant to this decision, on April 1,
1987, the Agency issued a FIFRA Section 18 Emergency Exemption
which granted a specific exemption to the States of Washington
and Idaho for the use of dinoseb to control broadleaf weeds
in dry peas, chickpeas and lentils.

     Attached is an amendment to the October 7, 1986 Compliance
Strategy for the Emergency Suspension of Dinoseb, pursuant to
the April 1, 1987 Agency actions.  Please transmit a copy of
this document to the States.  Please note that because of the
nature of this action, this amendment is immediately effective.
If you have any questions or comments regarding this amended
strategy, please contact Dan Helfgott of my staff at FTS 382-7825
(EN-342).
Attachment

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                            ADDRESSEES
     Douglas D. Campt
     Frederick F. Stiehl
     Stanley Abramson
     Ken Shiroishi
     Phyllis Flaherty
     John Martin
     John J. Neylan III
     Ralph Turpi n
     Jerry Stubbs
     Mike Wood
     Dexter Goldman
                           (TS-766C)
                           (LE-134A)
                           (LE-132A)
      Jake Mackenzie
      Western  Regional Compliance Director

      A. Charles  Lincoln
      Eastern  Regional Compliance Director

 I     Louis  F. Gitto,  Director
      Air Management Division

 II    Barbara  Metzger, Director
      Environmental Services Div.

•I I   Stephen  R.  Wassersug, Director
^    Hazardous Waste  Management Div.

 IV    Winston  A.  Smith, Director
      Air, Pest.  & Toxic Mgmt Div.

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

 VI    William  B.  Hathaway, Director
      Air, Pesticides  & Toxics Div.

 VII   William  A.  Spratlin, Director
      Ai r &  Toxi cs Divi sion
VIII  Irwin L. Dickstein,  Director
     Air & Toxic Subs.  Division

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

X    Gary O'Neal , Director
     Ai r & Toxi c Divi si on
                                         Gerald  M.  Levy,  Chief
                                         Office  of  Pesticides &  Toxic  Sub,

                                         Ernest  Regna,  Chief
                                         Pesticides  &  Toxics Sub.  Branch

                                         Larry Miller,  Chief
                                         Toxic & Pesticides Branch
H. Kirk Lucius,  Chief
Pesticides & Toxic Subs.  Branch

Phyllis Reed, Chief
Pesticides & Toxic Subs.  Branch

Norman E. Dyer,  Chief
Pesticides & Toxics Subs. Branch

Leo Alderman, Chief
Toxics & Pesticides Branch

Alvin Yorke, Chief
Toxic Substances Branch

Richard Vaille,  Chief
Pesticides & Toxics Branch

Anita Frankel , Chief
Pesticides & Toxic Subs.  Branch
     Jim Lamb
                     (TS-788)

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                         AMENDMENT TO THE
                   COMPLIANCE STRATEGY FOR THE
                 EMERGENCY SUSPENSION OF DINOSEB
OVERVIEW
    On March 30, 1987, the Administrator of the Environmental
Protection Agency (EPA) signed the Decision and Final  Order
Modifying Final Suspension of Pesticide Products Which Contain
Dinoseb.  In this document, the Administrator modified his
October 7, 1986 Emergency Suspension Order of Dinoseb  to allow
emergency exemptions to be granted under FIFRA Section 18 to
the States of Washington and Idaho during 1987.  Pursuant to
the Administrator's decision, the Agency issued the FIFRA
Section 18 Emergency Exemption on April 1, 1987, which granted
a specific exemption to the Washington and Idaho Departments
of Agriculture for the use of dinoseb to control broadleaf
weeds in dry peas, chickpeas and lentils.

     Under the Section 18 Notice, the Washington and Idaho
Departments of Agriculture are responsible for ensuring that
all  the provisions of the Emergency Exemption are met  within
their States.  These States are responsible for conducting
inspections at the dealer and user levels to assure compliance
with the terms and conditions of the April 1, 1987 Emergency
Exemption.  Regions will monitor compliance with the amended
federal  SSURO in accordance with the Pesticides Inspection
Manual .
REQUIREMENTS	

     The April 1, 1987 FIFRA Section 18 Emergency Exemption
permits dinoseb pesticide products which were federally registered
for use on peas, chickpeas or lentils prior to October 7,  1986,
to be shipped, sold and used (this includes dinoseb products
which were cancelled as a result of the October 7, 1986 Notice
of Intent to Cancel).  Shipment is allowed under the previously
federally-registered product label, and under the terms and
conditions specified in the Section 18 Emergency Exemption and
the Amendment to the SSURO (see attached).  Sale and use is
allowed only under the terms of the Section 18 Exemption.
COMPLIANCE           	

     The Agency will modify, upon request by the registrant,
the October 7, 1986 Stop Sale, Use or Removal  Order (SSURO)
to permit registrants to distribute, sell, offer for sale,
hold for sale, ship, deliver for shipment, receive and (having
so received) deliver or offer to deliver, remove, or use pesticide
products containing dinoseb pursuant to the terms and  conditions
of the April 1, 1987 FIFRA Section 18 Emergency Exemption for
dinoseb pesticide products.  Registrants who have not  requested
and been granted an amended federal  SSURO may  not sell or
distribute their dinoseb products.

-------
                              -2-


     Reglstrants are required to submit to EPA Regional
representatives listed in the amended SSURO the following
information within five working days of transporting affected
dinoseb products: 1) the product name and registration number
of transported product(s);  2) the date, name and location from
where the product(s) were transported as well as the name and
location of state-licensed  dealer(s) in Washington or Idaho to
whom the product(s) were shipped; and 3) the quantity of product(s),
by registration number, being transported.  The EPA Regional
representative will transmit this information to Region  X
within five working days.  Region X will further transmit this
same information to the States of Washington and Idaho,  within
five working days, for use  by the States in targetting inspections.
The Regions will report monthly to the Office of Compliance
Monitoring (OCM) on the location and quantities of dinoseb stocks
transported to and from their Regions until August 31, 1987.
OCM will compile a summary  of dinoseb movement between Regions
and transmit monthly reports to the Regions.

     EPA Region X and the States of Washington and Idaho are
directed to amend any SSUROs issued at the dealer and user
levels to permit sale and use of pesticide products containing
dinoseb pursuant to the terms and conditions specified in the
April 1, 1987 FIFRA Section 18 Emergency Exemption.

     Under the Section 18 Exemption, the Washington and  Idaho
Departments of Agriculture  are responsible for ensuring  that
all the provisions of the Emergency Exemption are met within
their States.  These States are responsible for conducting
inspections at the dealer and user levels to assure compliance
with the terms of the April 1, 1987 Exemption.  The specific
number of inspections will  be negotiated by EPA Region X with
the States of Idaho and Washington.  Regions will  monitor
compliance with the amended federal SSUROs according to  the
Pesticide Inspection Manual.

     Any distribution or use of pesticide products containing
dinoseb not in accordance with the FIFRA Section 18 Exemption
is considered a violation of the FIFRA Section 6 Suspension/
Cancellation Order, as modified by the Administrator on  March
30, 1987.

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EPA1H51
B. Prendergast

EPA9401
Jon Heller

WA/DOA
EPX5675
ATTN:  Mr. C. Alan Pettibone, Director

/ZIP
Regional Director HPR-01
Pood and Drug Administration
909 1st Avenue Room 5009
Seattle WA  9817H,
/ZIP
Branch Chief HFF-3U
PDA/CFSAN
200 C Street S.W.
Washington DC  2020*1,
/ZIP
John A. Beare M.D.
Health Services Division
Mail Stop LJ-18
Olympia WA  9850H+

Washington Department of Agriculture

Attention: Mr. C. Alan Pettibone - Director

The Environmental Protection Agency hereby grants a specific
exemption, in accordance with the Administrator's Decision
and Final Order Modifying Final Suspension of Pesticides
which Contain Dinoseb and section 18 of the Federal Insecticide,
Fungicide and Rodenticide Act, as amended, to the Washington
Department of Agriculture for use of dinoseb to control
broadleaf weeds in dry peas, chickpeas and lentils.  The
Washington Department of Agriculture is responsible for ensuring
that all provisions of this specific exemption are met.  It
is also responsible for providing information in accordance
with *»0 CFR 166.32.  This specific exemption is subject to
the following conditions, restrictions, and warnings:

FORMULATION

1.  This specific exemption authorizes the use of any
3 Ib. a.i. per gallon formulation of dinoseb which was
federally-registered for use on peas, chickpeas, or lentils
prior to October 7, 1986, subject to the terms and conditions
set forth below.

2.  Only that product which was formulated prior to October 7,
1986, is permitted to be shipped and used under this exemption.
Shipment is allowed under previously federally-registered product

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                             -2-
LABELING TO USED UNDER THE SPECIFIC EXEMPTION

     The provisions of this specific exemption constitute
supplemental labeling to the labels of previously registered
dinoseb products which are authorized for use under this
exemption.  Therefore, the state must ensure that this supple-
mental labeling accompanies the dinoseb product at the time
of sale.  The state must also ensure that growers with dinoseb
supplies already in  their possession be supplied a copy of
this supplemental labeling prior to use.  All appropriate
precautions and restrictions of the registered product labels
must be observed.  The following precautions and restrictions
take precedence over  those contained on the registered labeling.

1.   Due to developmental toxic effects in laboratory animals/
resulting from exposure to dinoseb, the following precautions
will be observed:

     Women of childbearing age may not use the product;
     all reasonable efforts should be made to minimize
     indirect exposures to women of child-bearing age;
     the product also poses risks to male reproduction;
     is acutely toxic and the product may be applied only
     by certified applicators.

2.   All use must be  made by certified applicators; other
persons, even if they are operating under the direct supervision
of  a certified applicator, may not use dinoseb.

3.   Women of childbearing age, i.e., under the age of 45,
may not be  involved  in mixing, loading, or any  aspect  of
dinoseb application.

4.   Mixing and  loading of dinoseb must be carried out in  a
closed system.

5.   Mixer/loaders and applicators must wear chemical  resistant
disposable coveralls  (Tyvek® suits) and chemically resistant
gloves  when mixing or loading dinoseb.  Applicators or other
personnel must remove such protective clothing  immediately before
entering the  tractor cab  to avoid  cab contamination, but must
carry an unused set  of gloves and coveralls in  their cabs, to
be  used in  the event of spraying equipment malfunction and
repair during application.

6.   Aerial application is prohibited.

7.   Ground application is prohibited except by the "barrel
sucker"/ground boom/tractor system.   Ground  application
is  restricted to a closed-cab tractor with a positive  pressure
ventilation system.

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                             -3-
8.   Ground application is prohibited when wind  conditions
exceed ten miles per hour.

9.   Application is limited to a maximum of 80 acres treatment
per day per certified applicator.

10.  One preemergent or early post emergent application of
dinoseb at a maximum application rate of 1.5 Ib. a.i. per
acre on lentils and 3.0 Ib. a.i. per acre on dry peas or
chickpeas is authorized.

11.  EPA recommends that growers should make every reasonable
effort to return unused dinoseb product to the manufacturer,
distributor, or  other  agents  capable of relabeling, recovering,
recycling, or reprocessing the pesticide.  Product which is
not  returned should be stored in accordance with recommended
procedures described in 40 CFR 165.10. In short, these proce-
dures  for  storage  recommend  that the material be stored  on
pallets or similar raised platforms  in a dry, well-ventilated,
and  separate  room, building  or  covered  area with a  concrete
floor, where  fire  protection  is  provided.

SPECIFIC  EXEMPTION REQUIREMENTS

 1.   Dinoseb  may only be  sold to growers  of dry peas,  lentils
 and/or chickpeas  in the state of Washington.

 2.   Growers  may purchase in a quantity not  to  exceed that
 required to treat his dry pea, chickpea,  and/or lentil
 acreage at the maximum application rates  specified in this
 authorization.  All stocks of dinoseb already in a grower's
 possession must be taken  into account when determining this
 quantity.

 3.   Only state-li\censed dealers are authorized to sell or
 ditribute dinoseb under this specific exemption.

 4.   Dealers authorized to sell or distribute dinoseb under
 this specific exemption must obtain and report  the following
 information from  growers prior to sale or distribution:
       a)   grower's name,  address,  and grower's license number,
       b)  number  of acres and type(s) of pulse crop to be treated,
       c)  the product name(s) and registration number(s),
       d)  the quantity of dinoseb sold or distributed,
       e   quantity of dinoseb previously in grower's possession, and
       f)  the name, address  and certification  number  of  the
           certified applicator to apply dinoseb.

  This  information  will be forwarded  by  the dealer  to  the Washington
  Department of Agriculture and the EPA Region X Office within
  five  days of sale or  distribution.

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                             -4-
5.   Certified applicators applying dinoseb under  this  specific
exemption will record and report the following information:
      a)  name, address and. certification number,
      b)  name and address of dry pea, lentil and/or chickpea
      grower,
      c)  date of application,
      d)  type of pulse  crop  and  number  of acres treated,
      e)  number of gallons applied,
      f)  registration number(s)  of  product(s) applied, and
      g)  sex of certified applicator  (if female, specify age).

This  information will  be forwarded to  the certified applicator
within  five days of use  to the Washington Department of Agriculture
and the EPA  Region X Office.

6.  The Washington  Department of Agriculture will  conduct a
monitoring  program of  use of  dinoseb under the specific exemp-
 tion  to insure compliance with the conditions and  restrictions
set forth in this exemption.   The specifics  concerning this
monitoring  are to determined  by the  Washington Department of
Agriculture and  EPA  Region X.

 7.   A final report summarizing the results of this exemption
must  be submitted  by January  15,  1988.  If  use of  dinoseb is
 required again for the  1988 growing season,  an interim report
 containing  all information available at  time of  filing, must
 be submitted with the new specific exemption request.

 8.  The Washington Department of Agriculture will  immediately
 report any adverse effects resulting  from the use of dinoseb
 under  this specific exemption to the EPA, Office of Pesticide
 Programs.

 9.  This specific exemption  expires on  July  15, 1987.

      The Agency will  not consider any emergency exemption
 application for the 1988 use season unless  the  Idaho or
 Washington Department of Agriculture, the American Frozen
 Food Institute, or  the American  Dry Pea and Lentil Association
 conduct  or  sponsor  adequate  tests on  alternative pesticides
 during the 1987 season.  EPA's consideration of any  emergency
 exemption  application for the 1988  use  season will be influenced
 by evidence of the extent to which there is good  faith compliance
  with the conditions and restrictions herein.
   ouglaS
  Office
  Date
 D. Campt,
of Pesticide Programs
   §§§

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                UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                              WASHINGTON, D.C. 20460

                                  AMENnMENT
                        TO THF SSDPO OF  OCTOBER 7, 1986
     ADR   I  |Qp7
              WO1
         ..  .	
PESTICIDES AND TOXIC SUBSTANCES
CERTIFIED MAIL
RETURN RECTlPT REQUESTED

Cedar Chemical
Suite 2414 Clark Tower
5100 Poplar Ave.
Memphis, TN  38137

Reference: DINOSEB

     By the authority vested in  me  pursuant to Section 13(a) of the Federal
Insecticide, Fungicide, and Rodenticide  Act (FIFRA), as amended (7 U.S.C.
§136k(a)), you are hereby ordered not  to distribute, sell, offer for sale,
hold for sale, ship, deliver for shipment, receive and (having so received)
deliver or offer to deliver, remove, or  use the pesticide(s) listed above,
or any other pesticides under your  control, ownership, or custody that were
suspended by the Administrator's Emergency Suspension Order of October 7, 1986.

     This order pertains to all  quantities of the above-mentioned pesticide(s)
within the control, ownership, or custody of your company, wherever located.
The pesticide(s) may not be sold, offered for sale, held for sale, shipped,
delivered for shipment, received and  (having so received) delivered or offered
for delivery, removed or used other than in accordance with the provisions of
this order or of further Stop Sale, Use, of Removal Orders as may be issued in
connection with the pesticide(s).

     Notwithstanding the provisions of this Stop Sale, Use, or Removal Order,
you may distribute, sell, offer  for sale, hold for sale, ship, deliver for
shipment, receive and (having so received) deliver or offer to deliver, remove,
or use the pesticide(s) affected by this order which are under your control,
ownership,.or custody provided it is for purposes of consolidation in one or
more locations, e. g., implementing a  product recall and/or it meets all the
requirements of the enclosed Section 18  Emergency Exemption Order and that it is
being shipped to a licensed, authorized  dealer in the States of Washington or Idaho,

     In addition, the following  information must be reported in writing to the EPA
representative listed below within  five  working days of transporting this material:
1) the product name and registration number of the transported products(s); 2) the
date, name and location from where  the product(s) were transported as well as the
name and location of distributors in Washington or Idaho to whom the product(s)
were shipped; and 3) the quantity of product(s) by registration number being
transported.

                     Mr. Kirk Lucius,  Chief
                      Pesticides and Toxic
                      Substances Branch
                     FPA Region  IV
                     345 Court!and  Street, NE
                     Atlanta, GA 30365
                     404-257-3621

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                                   - 2 -
     Any person violating the terms or provisions  of  this  order  shall  be
subject to the civil or criminal  penalties  prescribed in Section 14  of the
Act (7 U.S.C.§1361_).
                                         alph M.  Turpirt/Acting  Director
                                        Compliance  Division  (EN-342)
Enclosure

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'«<
           UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                       WASHINGTON, D.C. 20460
                           APR I 7 1987
       OFFICE OF
PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM

SUBJECT:  Dinoseb

FROM: n   A. E. Conroy II, Director    (^
      !/y  Office of Compliance Monitoring

TO:       Regional Division Directors


     On April 16, 1987, District Court Judge Redden of the
District of Oregon granted a preliminary induction which stayed
the dinoseb Suspension Order, in the States of Idaho, Oregon, and
Washington, pending EPA's final decision with respect to the
cancellation of dinoseb.  Further, Judge Redden's order permits
the use of dinoseb on green peas, snap beans, cucurbits (cucumbers,
squash and zucchini) and caneberry crops in these States.

     The above uses are only permitted under certain restrictions
set out in the Judge's order, provided that the aforementioned
States will agree to enforce these restrictions.  The Court Order
has been magnafaxed to you separately.

     While the Court's decision is not abundantly clear, it is
OCM's opinion that the scope of the decision is limited to the
States of Idaho, Oregon and Washington only.  Therefore, the
following guidance should apply to enforcing the October 14, 1986
dinoseb suspension order:

          1)  The Section 18 Emergency Exemption is not affected
              by the Court's decision.

          2)  The Court Order applies only to the States of
              Idaho, Oregon and Washington, and permits the use
              of dinoseb only on the crops listed above.  In
              these three States, the Court Order shall take
              precedence over the Agency's suspension order, and
              the Agency's Stop Sale Orders (SSURO) should not be
              enforced in those States.

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                     -2-


3)  Any sale, distribution and use of dinoseb,  in the
    three States, not in accordance with the restric-
    tions found in the Court Order or the Section 18
    Emergency Exemption is a violation of the suspension
    order.

4)  The Suspension Order is still  in effect outside of
    the three States.

5)  OCM has amended five SSURO's,  previously issued to
    registrants with stocks of dinoseb,  solely  for
    permitting these five registrants to ship dinoseb
    to Washington and Idaho for use under the Section 18
    Emergency Exemption.  No product can be shipped
    lawfully unless the product is registered for use
    on peas, lentils or chickpeas, and labelled accord-
    ingly.  The recent  section 18 Emergency Exemption
    extended allowable uses to Oregon and the five
    SSURO's are hereby amended to  Include this  State.

6)  No other shipments of dinoseb  (other than from the
    five registrants that received amended SSURO's) to
    the three States from outside  of the three  States
    are lawful.  Shipments of dinoseb by anyone other
    than the five registrants would be in violation of
    the Suspension Order (Section  12(a)(2)(J).

7)  We have contacted the States of Oregon, Washington,
    and Idaho concerning this matter.  If additional
    stocks of dinoseb are needed in these States for
    uses covered by the Court Order, EPA will expedite
    vacation of SSURO's using the  following procedure:

         o Registrants must contact the appropriate
           state department of agriculture and obtain
           agreement that the product may be shipped
           into the subject state  for an allowable use.
           Registrants should obtain an agreement from
           the state regarding the quantity of dinoseb
           product that may be shipped into the state.

         o Contact EPA [telephone  1) Charles Auer at
           202-382-3807; Dr. Jake  Mackenzie  at 415-974-7279;
           or call 202-382-3807 and request dinoseb
           coordinator] with the following information:

                - State contact and amount approved
                  for shipment.

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                             -3-

                - Registration number of product(s)  and
                  1abeled uses.

                - name and location of where product(s)
                  are shipped from and name and  location
                  of person receiving the product(s)

                - Date of shipment or proposed shipment
                  and quantities of product in each  shi
3 II I pine II I
each shipment.
                - Name, title, address,  and phone  number  of
                  company contact.

     EPA will verbally vacate SSURO's using the above procedure.
Companies should follow-up with EPA in writing.  EPA Headquarters
will provide information regarding vacation of SSURO's to the
appropriate regions.

     You should immediately discuss this matter with your State
counterparts to inform them of the Agency's position concerning the
Court decision.  In addition, the appropriate Regions should
contact the five registrants with amended SSURO's  to inform them
of this position.  The five registrants are:

          1.  Uniroyal Chemical            Region  1
              Bethany, CY

          2.  Cedar Chemical               Region  4
              Memphis, TN

          3.  Drexel Chemical              Region  4
              Memphis, TN

          4.  Platte Chemical              Region  8
              Greeley, CO

          5.  Wilbur Ellis Company         Region  9
              Fresno, CA

     We will keep you informed of further developments in this
matter and we will  discuss this during the April 22 OPP conference
call.  If you have any questions, please call Jack Neylan or Dan
Helfgott at FTS 382-7835.

cc:  Dr. John Moore, OPTS
     Jim Lamb, OPTS
     Doug Campt, OPP
     Stan Abramson, OGC
     Jake Mackenzie
     Chuck Lincoln
     Regional Branch Chiefs

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             UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                         WASHINGTON, D.C. 20460
                           MAR I  4  'OPQ
                                                           orr.ctor
                                                   'MTICIDCS AND TOXIC SUBSTANCES
MEMORANDUM
SUBJECT:  FIFRA Section 18 for Dinoseb

FROM:      John J.  Neylan III, J)1 recto r
          Policy and Grants Division
          Office of Compliance Monitoring
TO:
                                                       cT?
          Addressees
     On March 14, 1988, the Agency issued FIFRA Section 18
Emergency Exemptions which granted a specific exemption to the
States of Washington, Idaho, and Oregon to allow the use of
all  dinoseb products labeled for use on dry peas, lentils,
and  chickpeas to control broadleaf weeds on these crops (this
includes dinoseb products which were cancelled as a result
of the October 7, 1986 Notice of Intent to Cancel).  Sale,
distribution, and use of these dinoseb products are only
allowed under the terms and conditions specified in the attached
Section 18.  Additionally, the April 16, 1987 District Court
Order which permitted the use of dinoseb on green peas, snap
beans, cucurbits (cucumbers, squash and zucchini) and caneberries,
pursuant to the terms and conditions specified in that order,
is still in effect.    The States of Washington, Idaho, and Oregon
have promulgated emergency regulations which implement the 1987
Oistri ct Court Order.

    Under existing Stop Sale, Use, or Removal Orders (SSUROs),
Cedar Chemical and Orexel Chemical Company were permitted to
ship dinoseb products for purposes of consolidating stocks for
the  formal  recall.  Additionally, after notifying EPA and
obtaining approval from the State of Washington, Idaho or Oregon,
Cedar and Drexel were permitted to sell and distribute dinoseb
for  the uses allowed under the District Court Order (green peas,
snap beans, cucurbits, and caneberry crops).  Under existing
SSUROs, other registrants were permitted to ship dinoseb only
for  purposes of consolidating stocks for formal recall.
Registrants may no longer sell or distribute dinoseb pursuant
to last year's Section 18 Exemptions because these exemptions
expired on July 15,  1987.

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                              -2-
     In order to Implement  the new FIFRA  Section  18  Emergency
Exemptions and continue  to  implement  the  District  Court  Order,
the Agency will  amend  existing dinoseb  SSUROs  to  permit  the
sale,  distribution,  and  uses  specified  in  the  Section  18
Exemptions and the State regulations  which implement  the 1987
District Court Order,  using the following  procedures:

     0  Registrants  must contact the  appropriate  State
        Departments  of Agriculture and  obtain  agreement
        that the product may  be shipped  into  the  subject
        State for an allowable use.   Registrants  must  obtain
        an agreement from the State  regarding  the  quantity
        of dinoseb product  that may  be  shipped into  the  State.

     0  Registrants  must contact EPA  by  telephone  [  1) John Mason
        at 202-382-7835; 2) Jake Mackenzie at  415-974-7279; or
        (3)  call  202-382-3807 and request  the  dinoseb  coordi-
        nator] and provide  the following  information:

             - State contact  and amount  approved  for
               shipment.

             - Registration number of product(s)  and
               labeled uses.

             - Name  and  location of  product(s)  to  be
               shipped and  name and  location  of person
               receiving the  product(s).
                                                     and
             - Date of shipment or proposed shipment a
               quantities of product in each shipment.

             - Name, title, address, and phone number of
               company contact.


     Companies must also provide the above information to the
EPA Office of Compliance Monitoring (OCM) in writing subsequent
to their Initial  phone call which requested the amendment to
the SSURO.  OCM will provide those registrants that request
permission to ship dinoseb with a written amended SSURO.  OCM
will  also provide Information regarding the amended SSUROs to
the appropriate Regions and EPA personnel involved in handling
dinoseb indemnification claims.  Registrants who have not requested
and been granted  an amended federal SSURO may not move or ship
their dinoseb products, except for purposes of consolidating stocks
for the formal recal1 .

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                              -3-
     The following  guidance will apply for enforcing  the  October
7,  1986 dinoseb-'suspension order and  subsequent  cancellations:


     1) Any   saje-,  distribution,  and  use  of dinoseb,  in  the
        three States,  not in  accordance  with the restrictions
        found in  the 1988  FIFRA section 18 Emergency  Exemptions,
        or the 1987 District  Court  Order,  as  implemented  by
        the  regulations  of  the  States  of  Washington,   Idaho,
        and  Oregon,  is  a  violation   of  the  FIFRA   section  6
        Suspension/Cancellation  Order.

     2) No  product  can  be shipped lawfully  for  use under  the
        Section  18  unless:  (1)  the  product  was   registered,
        packaged, and  labeled  on  October  7,  1986,  or  (2)  the
        product  was  manufactured  from  stocks of  a   registered
        technical dinoseb  product  which were  packaged  and
        labeled,  and  in  the   possession  of  the  manufacturer,
        on or before October 7,  1986.

     3) No   product  can   be   shipped  lawfully  for   use  under
        the  State   regulations  which   implement  the  District
        Court Order  unless:  (1)  the  product  was   registered,
        packaged, and  labeled  on  October  7,  1986,  or  (2)  the
        product  was  manufactured  from  stocks of  a   registered
        technical dinoseb  product  which were  packaged  and
        labeled,  and  in  the   possession  of  the  manufacturer,
        on or before  October   7,  1986,  and  (3)  has  not  yet
        been  cancelled  pursuant  to the  October 7, 1986
        Cancellation Order.

     4) No dinoseb  product may  be distributed  or sold  for  use
        on dry peas, lentils,  chickpeas,  green peas,  cucurbits,
        snap  beans,  or  caneberries,  unless  the product  was
        previously  labeled for these  uses.

     5) Registrants  that  did   not  receive  an  amended   SSURO,
        who  ship  dinoseb  to  the  three   States,  will   be  in
        violation of the FIFRA Section 6 Suspension/Cancellation
        Order and  in  violation of the SSURO  issued  under  FIFRA
        Section  13.

     6) Only  pesticide  dealers licensed by  the  State  of
        Washington,  Idaho, and  Oregon  may  sell  or  distribute
        dinoseb  products  for  use under the FIFRA Section  18 or
        the  State regulations  which  implement the 1987 District
        Court Order.

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                              -4-
     7) Distributors, dealers, and retailers located in other
        States may ship'di noseb. stock s to licensed, authorized
        dealers in the State of Washington, Idaho, and Oregon
        for use consistent with the FIFRA Section 18 Emergency
        Exemptions or the State regulations which implement the
        1987 District Court Order, provided the distributor,
        dealer, retailer has obtained approval  from the State.
        Distributors, dealers, retailers who have previously
        been issued a State or Federal  SSURQ must have that
        SSURO amended before such shipment may  occur.   Further,
        such shipment must be in  accordance with U.S.  Department
        of Transportation regulations.

     8) Use of dinoseb product in the three States for broadleaf
        control of dry peas, lentils, and chickpeas must be in
        accordance with the use limitations specified  in the
        attached March 14, 1988 FIFRA section 18.

     9) Use of dinoseb product in the three States on  green -peas,
        snap beans, cucurbits, and caneberry crops must be in"
        accordance with the use limitations specified  in the
        State regulations implementing the April  16, 1987,
        District Court Order.

    10) Use of dinoseb in the three States not  in accordance
        with the Section 18 or State regulations implementing
        the District Court Order  is a violation of the FIFRA
        section 6 Suspension/Cancellation Order.

    11) No dinoseb products may be used outside the three
        States.  Use of dinoseb outside the three States is a
        violation of the FIFRA section 6 Suspension/Cancellation
        Order.


     EPA Region X and the States  of Washington, Idaho, and
Oregon are directed to amend any  SSUROs issued  at the  dealer
and user levels to permit sale and use of pesticide products
containing dinoseb pursuant to the terms and conditions specified
in the March 14, 1988 FIFRA Section 18 Emergency Exemptions and
the State  regulations implementing the 1987 District Court
Order, if this has not already been done.

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                              -5-
     Under the -Section 18 Exemptions and the District Court Order
the States of Washington,- Idaho, and Oregon are responsible for
ensuring that all the provisions of the Emergency Exemptions and
District Court Order are met within their States.  These States
are responsible for conducting inspections at the distributor,
dealer, retailor and user levels to assure compliance with the
terms of the March 14, 1988 FIFRA Section 18 Emergency Exemptions
and the State regulations implementing the 1987 District Court
Order.  These States are also responsible for assuring that
products sold and distributed for use under the FIFRA Section 18
Exemption are not used for the uses allowed under the State
regulations which implement the 1987 District Court Order (only
Cedar and Drexel's dinoseb products will be allowed for use
on green peas, snap beans, cucurbits, and caneberry crops).
The specific number of inspections will be negotiated by EPA
Region X with the States of Washington, Idado, and Oregon.
Regions will monitor compliance with the amended federal  SSUROs
according to the Pesticides Inspection Manual.

     Please note, the FIFRA Section 18 Emergency Exemptions "  .
issued on March 14, 1988 will  expire upon issuance of the final
dinoseb cancellation order (which is expected shortly), or
July 15, 1988, whichever comes first.  Further, use under the
1987 District Court Order and State regulations must also
cease after issuance of the final  dinoseb cancellation order.
Therefore, upon issuance of the final dinoseb cancellation
order, sale, distribution, and use of dinoseb products will
only be permitted consistent with the terms and conditions
specified in that order.

     You should immediately transmit a copy of this memorandum
to the States and discuss these dinoseb actions with them.  If
you have any questions regarding this memorandum, please contact
nan Helfgott at FTS 382-7825.
Attachment

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                            ADDRESSEES
II
      John A. Moore        (TS-788)
      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 FXaherty       "
      Mike Wood              "
      Jerry Stubbs           "
      Dexter Goldman         "
      Jan Auerbach         (TS-767C)
      Jane Hopkins         (TS-788)
      Phil Gray            (TS-766C)

      Jake Mackenzie
      Western Regional Compliance Director
      Louis F. Gitto, Director
      Air Management Division

      Barbara Metzger, Director
      Environmental Services Div
III   Stephen R. Wassersug, Director
      Hazardous Waste Management Div

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

V     William H. Sanders III, Dir
      Environmental Services Div

VI    William B. Hathaway, Dir
      Air, Pesticides & toxic Div

VII   William  A. Spratlin, Director
      Air and Toxics Division

VIII  Irwin L. Dickstein, Director
      Air and Toxics Division

IX    Jeffrey Zelickson, Director
      Toxics and Waste Management Div

X     Gary O'Neal, Director
      Air and Toxics Division

      Chris Kirby
      Oregon Dept. of Agriculture

      Art Losey
      Washington Dept. of Agriculture
Marvin Rosenstein, Chief
Pesticides & Toxic Substances Br

Ernest Regna, Chief
Pesticides & Toxic Substances Br

Larry Miller, Chief
Toxic & Pesticides Branch

Richard DuBose, Chief
Pesticides & Toxic Substances Br

Phyllis Reed, Chief
Pesticides & Toxic Substances Br

Robert Murphy, Acting Chief
Pesticides & Toxic Substances Br

Leo Alderman, Chief
Pesticides & Toxic Substances Br

Alvin Yorke, Chief
Toxic Substances Branch

Davis Bernstein, Chief
Pesticides & Toxics Branch

Anita Frankel, Chief
Pesticides & Toxic Substances Br

Rod Awe
Idaho Dept. of Agriculture

Vivan Jennings
U.S. Dept. of Agriculture

-------
             UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                         WASHINGTON, D.C. 20460
                              MAR 2 8 1988
                                                           OFFICE OF
                                                   PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM

SUBJECT:
FROM:
TO:
           Dinoseb Stipulated Order
                                       r
           John J. Neylan III, Director'^
           Policy and Grants Division
           Office of Compliance Monitori

           Addressees
     On March 24, 1988, the counsel for the Environmental
Protection Agency and the plaintiffs in Love V. Thomas,  filed
the enclosed stipulation in that case, which describes those
activities which are lawfully permitted by the April 15, 1987
District Court Order and the State regulations implementing
that Order.  From the Agency's perspective, this stipulation
merely reaffirms the situation as it existed prior to the
filing of the stipulation.

     To prevent any misunderstanding, I have also attached
(1) a list of dinoseb products which are not cancelled and are
labeled for uses subject to the April 15, 1987 District  Court
Order, and (2) a copy of the March 14, 1988 memorandum which
provides information concerning the Agency's enforcement policy
for dinoseb.  If you have any questions regarding this letter,
please contact Dan Helfgott of my staff at FTS 382-7825.
Attachments

-------
  1    Susan K. Eggum
      McEWEN, GISVOLD,  RANKIN & STEWART
  2    1408 Standard Plaza
      1100 SW Sixth Avenue
  3    Portland, OR 97204
      Telephone:  (503) 226-7321
  4
      Phillip D. Chadsey
  6    STOEL, RIVES, BOLEY,  JONES & GREY
      900 SW Fifth Avenue
  6    Portland, OR 97204
      Telephone:  (503) 294-9376
  7
           Attorneys for Plaintiffs
  8

  9                    UNITED  STATES DISTRICT COURT

10                          DISTRICT OF OREGON

11    JAMES M. LOVE, NORTHWEST FOOD      )
      PROCESSORS ASSOCIATION,  a          )
12    non-profit association,  and        )
      TUALATIN VALLEY FRUIT              )
13    MARKETING, INC.,  an Oregon         )
      corporation,                        )
14                                        )
                     Plaintiffs,          )     Civil No.  87-343-RE
15                                        )
      DAVE FROHNMAYER,  Attorney          )
16    General for the State of           )
      Oregon, on behalf of  the         .  )
17    people of the State of  Oregon      )
                                          )
18                   Intervenor,          )
                                          )
19                   v.                   )     STIPULATED ORDER
                                          )
20    LEE M. THOMAS, Administrator       )
      Environmental Protection           )
21    Agency,                             )
                                          )
22                        Defendant.      )

23         On March 11, 1988,  plaintiffs filed a Motion  For  Order To

04    Show Cause Why The Defendant Should Not Be Held  In Contempt For

25    Violation Of This Court's Preliminary Injunction and Setting

26    Hearing.   In response to plaintiffs'  motion, counsel for plaintiffs

Page  1  -  STIPULATED ORDER

                            McEWEN, GISVOID. RANKIN & STEWART
                                  Anomm of Law
                             1408 Standard Plaza. IIOOS. W. Sixth
                                Portland. Oitqon 97204
                                Tel.phoo. {5031 226-7321

-------
 1    and for defendant have agreed  to  the  following terras of a stipullBId



 2    order:



 3       •  1.   All dinoseb products which  are  not cancelled (including



 4    but not limited to products manufactured  by Cedar and Drexel and



 5    their respective predecessors  and affiliates)  and which are the



 6    subject of this Court's April  15,  1987  injunction ("the injunction")



 7    may be  shipped into the states of Washington,  Idaho, and Oregon



 8    and sold,  distributed, and used  in  those  states for those crops



 9    (green  peas,  snap beans, cucurbits  and  caneberries) in accordance



10    with  the injunction and the state regulations implementing the



11    injunction.



12         2.   This stipulated order  shall remain in effect throughout



13    the 1988 growing season for the  crops which are the subject of



14    the injunction, or until the defendant  issues a final order in



15    the dinoseb cancellation proceeding,  FIFRA Docket No. 590, et



16    al.,  whichever occurs sooner.



17         3.   EPA has notified the manufacturers of affected products



18    of  these facts and will provide  the manufacturers, EPA regional



19    offices, and state agencies responsible for enforcement of FIFRA



20    with  notice of this stipulation  and a copy of this stipulated



21    order.



22         4.   Plaintiffs' Motion For  Order  To Show Cause Why



23    Defendant  Should Not Be Held In  Contempt  For Violation Of This



24    Court's Preliminary Injunction is hereby  withdrawn.



25         5.   Each party shall bear  its own costs and attorney fees




26    / / /



Page  2 -   STIPULATED ORDER




                            McEWEN. GISVOIO, RANKIN & STEWART
                                 Attorney* ot Low
                             1408 Standard Plaza. 1100 S W. Sixth
                                Portland. Oregon 97204
                               Telephone (5031 226-732)

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 1

 2

 3

 4

 5

 6

 7

 8

 9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

Page
incurred  in connection with the withdrawn  motion.
March  18,  1988.
3 -  STIPULATED ORDER
                                ROGER J. MARZULLA
                                Acting Assistant Attorney  General
                                Land & Natural  Resources Division
                                             L
                                SUSAN L. SMITH,  Assistant  Chief
                                Environmental  Defense Section Land
                                & Natural Resources Division U.S.
                                Department  of  Justice

                                Counsel  for Administrator  Thomas
                                SUSAN K. EGGUM,  McEwen, Gisvold,
                                Rankin & Stewart, Of Attorneys for
                                Plaintiffs
Is /
                                                9
                                PftlLLIP D.  CKADSEY, Stoel,  Rives,
                                Boley, Jones,  & Grey, Of Attorneys
                                for Plaintiffs
                             Me EWE N, GISVOID. RANKIN & STEWART
                                   Anomtyi ar low
                              1408 Standard Plata. 1100 S. W. Siith
                                  Portland, Oregon 97204
                                 Teltohont (5031 226-7321

-------
           DINOSEB PRODUCTS WHICH ARE NOT CANCELLED
           AND ARE LABELED FOR USES SUBJECT TO THE
           APRIL 15, 1987 DISTRICT COURT INJUNCTION

     This list consists of registered pesticide products
containing dinoseb which are 1) not cancelled, and 2) labeled
for use on crops which are subject to the April 15, 1987
injunction by the United States District Court in Oregon.  As
confirmed by the enclosed stipulation, these products may be
shipped into the states of Washington, Idaho, and Oregon, and
sold, distributed and used in those states in accordance with
the April 15, 1987 injunction and the state regulations
implementing the injunction.  To the extent that any stop
sale, use, or removal order previously issued by EPA represents
an impediment to such activities, EPA will modify that order
in accordance with the procedures set forth in the enclosed
March 14, 1988 memorandum.

     As of March 21, 1988, Cedar Chemical Corporation and
Drexel Chemical Company were the only companies whose dinoseb
registrations had not been cancelled.  However, many of the
registrations for dinoseb products currently held by Cedar
and Drexel were previously held by one or more other companies,
and then transferred to Cedar or Drexel.  Remaining stocks of
these transferred products which are labeled with the prior
brand names and registration numbers are not cancelled.  In
addition, a number of additional companies have obtained
supplemental registrations which permit them to distribute
Drexel products under other brand names.  These supplemental
registrations are also not cancelled.

-------
                                - 2 -
I.  Cedar Chemical Corporation

  A.  Current Cedar Chemical Corporation Registrations
     Transferred From Vertac Chemical Corporation

                                    Vertac        Cedar
                                   Chemical      Chemical
                                  Corporation   Corporation
  Product Name                      Reg. No.       Reg.  No.
  Dinitro Weed Killer               39511-10      56077-4

  Dinitro Weed Killer 5             39511-11      56077-5

  Selective Weed Killer             39511-85      56077-11

  General Weed Killer               39511-86      56077-12

  Premerge 3                        39511-87      56077-13

  Premerge                          39511-88      56077-14

  Dinitro 3 Weed Killer             39511-89      56077-15

  Dinitro General                   39511-91      56077-17

  B. Current Cedar Chemical Corporation Registrations
     Previously Transferred from Other Companies

                                    Former        Current
  Product Name (company)            Reg. No.      Reg. No.
  Selective Weed Killer (Dow)       464-10        56077-11

  Dow General Weed Killer (Dow)     464-98        56077-12

  Premerge (Dow)                    464-146       56077-14

  Premerge 3 Dinitro Amine          464-490       56077-13
    Herbicide (Dow)

  Helena Brand Dinitro Weed         5905-194      56077-5
    Killer 5 (Helena)

  Dinitro - 3 Weed Killer           9663-11       56077-15
    (Crystal)

  Dinitro General Herbicide         9663-18       56077-17
    (Crystal)

-------
                                - 3 -
II.  Drexel Chemical Company

  A. Current Drexel Chemical Company Registrations

       Product Name          Reg.  No.
       Dynamyte T

       Dynamyte 2.5

       Dynamyte 3

       Dynamyte 300

       Dynamyte 5

       Premerge Dinitro
       Weed Killer
19713-33

19713-78

19713-82

19713-28

19713-29

19713-203
  B. Registrations Transferred To Drexel
     Chemical Company from Other Companies

       Former Product          Former
       Name (Company)          Reg. No.
                  Current
                  Reg. No.
       Dynamyte T Dinitro      6308-89
         Weed Killer (Ansul)

       Trounce 3 Dinitro       6308-79
         Weed Killer (Ansul)

       Dynamyte 5 Dinitro      6308-80
         Weed Killer (Ansul)

       Dinoseb Dinitro Weed    1022-442
         Killer (Chapman)
                  19713-33


                  19713-28


                  19713-29


                  19713-203

-------
                              - 4 -
C. Supplemental Registrations for Drexel
   Chemical Company Products
     Product Name


     Hopkins Dinitro 3

     Dinitro 5

     Pure Gro Dinoseb 5

     Hopkins Dinitro 5

     Dino - 5 Dinitro Weed Killer

     Dinitro 5 Weed Killer

     Terra Dinitro-5

     Dinitro General

     Schall Contact Weed Killer

     Dinitro Contact Weed Killer

     Valco Brand-Beanweda

     Pure Gro Dinomerge 3

     Dino - 3

     USS Dinitro 3 Pre-Emergence
     Weed Killer

     Riverside Dinitrol 3

     Red Panther Dinitro 3

     Dinitro PE
Reg. No.
19713-

19713-

19713-

19713-

19713-

19713-

19713-

19713-

19713-

19713-

19713-

19713-

19713-

19713-
28-2393

29-635

29-1202

29-1063

29-2935

•29-3442

•29-14774

•29-44215

•78-3468

•78-44215

•82-1063

•82-1202

•82-2935

•82-3442
19713-82-9779

19713-82-42761

19713-82-44215

-------
            UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                        WASHINGTON, D.C. 20460
                            JUU5B66
                                                           OPPICB OP
                                                   PKSTICIDBS AND TOXIC SUBSTANCES
MEMORANDUM

SUBJECT:  Compliance Monitoring Strategy for
          Cancellation of Dinoseb
FROM:     John J. Neylan III, Director
          Policy and Grants Division
          Office of Compliance MonitorinA  J

TO:       Addressees
     On June 9, 1988, the Administrator of the Environmental
Protection Agency (EPA) signed the final Dinoseb Cancellation
Order.  This Order, which is effective June 10, 1988, cancels
all pesticide products containing dinoseb, or any of its salts,
which have not already been cancelled pursuant to the Notice of
Intent to Cancel (NOIC) issued on October 7, 1986 (51 FR 36650:
October 14, 1986).

     Pursuant to this Order, the Agency has authorized sale,
distribution, and use of dinoseb for certain crops for the 1988
and 1989 growing seasons in the States of Washington, Idaho,
and Oregon.  Also pursuant to the Cancellation Order, the State
Departments of Agriculture of Washington, Idaho, and Oregon
have agreed to enforce all the provisions of the June 10, 1988
final Dinoseb Cancellation Order.  Finally, please note that
all sale, distribution, and use of dinoseb permitted under the
1988 FIFRA section 18 emergency exemptions, the 1987 U.S.
District Court Order, and amended federal Stop Sale, Use, or
Removal Orders, are now prohibited.  All sale, distribution, and
use of dinc^pb must now be in accordance with the final Dinoseb
CancellattfJifFOrder.  Therefore, use of dinoseb on snap beans
and cucurbiwSfis now prohibited.  Further, sale and
distribution of dinoseb for use on snap beans and cucurbits is
also prohibited.

-------
                              -2-
     Attached is the Compliance Monitoring Strategy for the
Final Cancellation of Dinoseb.  This Strategy calls for the
State Departments of Agriculture of Washington, Idaho, and
Oregon to conduct.inspections at the distributor, dealer,
retailer, and user levels to assure compliance with the final
Dinoseb Cancellation Order.  Further, the Office of Compliance
Monitoring, the Regions, and the States are to amend Stop Sale,
Use, or Removal Orders (SSUROs), as necessary, to allow sale,
distribution, and use only in accordance with the final
Cancellation Order.  Procedures for amending SSUROs will be
identical to those procedures outlined on page 2 of the
attached March 14, 1988 memorandum from John J. Neylan III,
entitled FIFRA Section 18»s for Dinoseb.  Regions are to
monitor compliance with the amended Stop Sale, Use, or Removal
Orders in accordance with Section 13 of the Pesticides
Inspection Manual.

     This attached Strategy is effective immediately, and
supersedes previous Agency guidance on the enforcement of
dinoseb actions, including the October 7, 1986 Compliance
Strategy for the Emergency Suspension of Dinoseb.  Please
transmit a copy of this Strategy, and the attached June 10,
1988 final Dinoseb Cancellation Order to the States within
your Region as soon as possible.  If you have any questions
regarding the attached Strategy, please contact Dan Helfgott of
my Staff (EN-342; FTS 382-7825).
Attachments

-------
                              3— /OOv_;
       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^      "
       Mike Wood       ~      "
       Jerry Stubbs           "
       Maureen Lydon          "
       Dexter Goldman         "
       Jan Auerbach         (TS-767C)
       Jane Hopkins         (TS-788)
       Phil Gray            (TS-766C)

       Jake Mackenzie
       Western Regional Compliance Director

I      Louis F. Gitto, Director         Marvin Rosenstein, Chief
       Air Management Division          Pesticides & Toxic Substances Br

II     Barbara Metzger, Director        Ernest Regna, Chief
       Environmental Services Division  Pesticides & Toxic Substances Br

III    Stephen R. Wassersug, Director   Larry Miller, Chief
       Hazardous Waste Management Div   Toxic & Pesticides Branch

IV     Winston A. Smith, Director       Richard DuBose, Chief
       Air, Pest. & Toxics Mangt. Div   Pesticides & Toxic Substances Br

       William H. Sanders III, pir      Phyllis Reed, Chief
       Environmental Services Division  Pesticides & Toxic Substances Br

VI     William B. Hathaway, Director    Robert Murphy, Acting Chief
       Air, Pesticides & Toxic Div      Pesticides & Toxic Substances Br

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

VIII   Irwin L. Dickstein, Director     Alvin Yorke, Chief
       Air and Toxics Division          Toxic Substances Branch

Dt     Jeffrey Zelickson, Director      Davis Bernstein, Chief
       Toxics and Waste Management Div  Pesticides & Toxics Branch

X      Gary O'Nea&s Director            Anita Frankel, Chief
       Air and Toxics Division          Pesticides & Toxic Substances Br

       Chris Kirby                      Rod Awe
       Oregon Dept. of Agriculture      Idaho Dept. of Agriculture

       Art Losey                        Vivan Jennings
       Washington Dept. of Agriculture  U.S. Dept. of Agriculture

-------
                 COMPLIANCE MONITORING STRATEGY FOR THE
                      FINAL CANCELLATION OF DINOSEB
   OVERVIEW
        On June 9, 1988, the Administrator of the Environmental
   Protection Agency- (EPA) signed the final Dinoseb Cancellation
   Order.   This Order, which was effective on June 10,  1988,  cancels
   pesticide products containing dinoseb,  or any of its salts,  which
   have not already been cancelled pursuant to the Notice of  Intent to
   Cancel  (NOIC) issued on October 7, 1986 (51 FR 36650; October 14,
   1986).   .--       V 3
        Pursuant to the terms of the Cancellation Order,  the Agency
   has authorized the sale, distribution,  and use of existing stocks
  /of dinoseb products for certain crops in the States of Washington,
/  Idaho, and Oregon.  Also pursuant to the Cancellation  Order,  the
   State Departments of Agriculture of Washington, Idaho, and Oregon
   have agreed to enforce all the procedures, terms, and  conditions of
   the June 10, 1988 Cancellation Order.  Therefore, the  States  of
   Washington, Idaho, and Oregon are responsible for conducting
   inspections at the distributor, dealer, retailer, and  user levels
   to assure compliance with the terms and conditions of  the June 10,
   1988 Cancellation Order in their States.

        All other Regions/States will conduct inspections at the
   registrant, producer, dealer, distributor, retailer, and user
   level, as part of their routine inspectional program,  to assure
   that no dinoseb stocks are being sold,  distributed, or used in
   violation of the final Dinoseb Cancellation Order.

  x/j   Please note that all sale, distribution, and use  permitted
   under the 1987 and 1988 FIFRA section 18 emergency exemptions,
   the 1987 District Court Order, and amended federal Stop Sale, Use,
   or Removal Orders (SSUROs) are now prohibited.  All sale,
   distribution, and use of pesticide products containing dinoseb must
   now be in accordance with the final Dinoseb Cancellation Order. 4 i
   ThereforeT-sale , -dist^ibution-.-and-tre^^f-dinoseb .qn,_snap beans
   and cucurbits (cucumbers, squash and zucchini) are ho  longer
   permitted.  The Office of Compliance Monitoring (OCM)  may amend
   federal SSUROs upon request of the dinoseb registrant  to permit
   sale, distribution, and yse^in accordance with the final Dinoseb
   Cancellation Order .*Hme procedures for amending these SSUROs will
   be the same aa those outlined on page 2 of the attached March 14,
   1988 memorandum from John J. Neylan, entitled FIFRA Section 18 fs
   for Dinosebtfu. The Agency will monitor compliance with  the amended
   federal Stop Sale, Use or Removal Orders (SSUROs) in accordance
   with section 13 of the Pesticides Inspection Manual.

-------
     Additionally, OCM may authorize the sale, distribution, or
shipment of existing stocks of cancelled dinoseb products by
registrants, distributors, dealers, or users located in States
other than Washington, Idaho, and Oregon to licensed dealers in
these States, when sale of existing stocks by the recipient dealer
is permitted pursuant to the Cancellation Order.  Such
authorization is contingent upon the registrant, distributor,
dealer, or user obtaining permission from the State Department of
Agriculture of the State to which the cancelled product is being
shipped.

     This Compliance Monitoring Strategy for the Final Cancellation
of Dinoseb is effective immediately, and supersedes previous
Agency guidance on the enforcement of dinoseb actions, including
the October 7, 1986 Compliance Strategy for the Emergency
Suspension of Dinoseb.
     The June 10, 1988 final Dinoseb Cancellation Order permits
the sale, distribution, and use of existing stocks of dinoseb
pesticide products: (1) for weed control on dry peas, lentils,
chickpeas, and green peas in the States of Washington, Idaho, and
Oregon during the 1988 growing season, and (2) for vegetative cane
control in caneberries (blackberries, boysenberries,  loganberries,
and raspberries) in Washington, and Oregon during the 1988 and 1989
growing seasons.

Regulated Industry	

     The June 10, 1988 final Cancellation Order specifically
cancels the dinoseb pesticide products of cedar Chemical
Corporation (formerly registered under Vertac Chemical) and Drexel
Chemical Company.

     The existing stocks provisions of the final Cancellation
Order affect:  (1) all registrants of dinoseb products, including
those registrants of products cancelled pursuant to the October 7,
1986 NOIC; (2) growers that use dinoseb on dry peas,  lentils,
chickpeas, green peas, and caneberries in the States of
Washington, Idaho, and Oregon; (3) dealers who are licensed by the
States of Washington, Idaho, and Oregon to sell cancelled dinoseb
pesticide pjroducts; and (4) registrants, distributors, dealers, or
users who sell, distribute, or ship cancelled dinoseb products to
licensed dealers in Washington, Idaho, and Oregon.

-------
                                -3-
Existina Stocks
     Cancelled dinoseb products may only be sold, distributed, and
used if: (1) the product was federally registered, packaged, and
labeled on October 7, 1986, or (2) the end-use product was
manufactured front stocks of a registered technical dinoseb product
which was packaged and labeled and in the possession of the
manufacturer, on or before October 7, 1986.  Cancelled dinoseb
products may only be sold and distributed for use on dry peas,
lentils, chickpeas, green peas, or caneberries if the product was
previously labeled for these crops.  Pesticide dealers in
Washington, Idaho, and Oregon must be licensed by their State in
order to sell or distribute cancelled dinoseb products.  These
dealers must record and submit dinoseb sales information to the
State Department of Agriculture and EPA Region X Office within 5
days of sale, distribution, or delivery of the cancelled dinoseb
product to a grower in Washington, Idaho, or Oregon.  The dinoseb
products may be sold and distributed only when accompanied by
supplemental labeling which includes the use restrictions and
warning statements contained in the June 10, 1988 final Dinoseb
Cancellation Order.  Further, use of all dinoseb pesticide products
may only be in accordance with the terms and conditions outlined in
the supplemental labeling.

     Please note that existing dinoseb Stop Sale, Use, or Removal
Orders (SSUROs), including those that were previously amended
pursuant to the 1987 and 1988 dinoseb FIFRA section 18 emergency
exemptions and Judge Redden's 1987 District Court Order, will not
permit registrants to legally sell, distribute, ship, etc., any
dinoseb products upon issuance of the final Dinoseb Cancellation
Order.  Therefore, the Agency must amend any existing dinoseb
SSUROs before a registrant may sell, offer for sale, hold for sale,
ship, deliver for shipment, receive and (having so received)
deliver or offer to deliver, or remove pesticide products
containing dinoseb for uses permitted by the final Dinoseb
Cancellation Order during the 1988 and 1989 growing season.

     Upon request by the dinoseb registrant, the Agency may modify
any existing SSUROs to permit the registrant to sell, offer for
sale, hold for sale, ship, deliver for shipment, receive and
(having so received) deliver or offer to deliver, and remove
pesticide products containing dinoseb which meet the conditions of
the final D4poseb Cancellation Order.  The exact procedures that
will be usedTta amend federal SSUROs is identical to those
procedures outlined on page 2 of the attached March 14, 1988
memorandum from John J. Neylan III, entitled FIFRA Section 18's for
Dinoseb.  Registrants who have not requested and been granted an
amended federal SSURO may not sell or distribute their dinoseb
products.

-------
     EPA Region X and the  States of Washington, Idaho, and Oregon
are directed to amend any  SSUROs issued at the distributor,
dealer, retailer, and user levels to permit sale and use of
pesticide product containing dinoseb pursuant to the terms and
conditions specified in  the final Dinoseb Cancellation Order.

     Other Regions and States are directed to amend any SSUROs at
the distributor, dealer, retailer, and user level to permit the
sale, distribution, and  shipment of dinoseb to licensed dealers in
the States of Washington,  Idaho, and Oregon, provided the person
has received permission  from the subject State.

     Finally, registrants,  distributors, dealers, retailers, or
users located in States  other than Washington, Idaho, and Oregon
must obtain authorization  from the Office of Compliance Monitoring
before they may ship existing stocks of cancelled dinoseb products
to Washington, Idaho, and  Oregon.   Such authorization is contingent
upon the registrant, distributor,  dealer, retailer, or user
obtaining permission from  the State Department of Agriculture of
the State to which the cancelled product is being shipped.

     Any sale, distribution,  or use of pesticide products
containing dinoseb not in  accordance with the final Dinoseb
Cancellation Order is a  violation of FIFRA sections 12(a)(2)(K) and
COMPLIANCE MONITORING
     Pursuant to the terms and  conditions of the final Dinoseb
Cancellation Order, the Departments  of Agriculture of the States of
Washington, Idaho, and Oregon are  responsible for ensuring that
all the provisions of the Cancellation Order are met within their
State.  These States are responsible for conducting inspections at
the dealer, distributor, retailer, and user levels to assure
compliance with the terms of the June 10, 1988 final Dinoseb
Cancellation Order.  These States  are also responsible for
responding to tips and complaints  of violations of the Cancellation
Order.

     All Regions/States are to  perform inspections at the
registrant, producer, dealer, distributor, retailer, and user
levels, as part of their routine inspections, to assure that no
person is distributing, selling, offering for sale, holding for
sale, delivering for shipment,  receiving (and having so received)
delivering, offering to deliver, or  using pesticide products
containing dinoseb in violation of the June 10, 1988 final Dinoseb
Cancellation Order.*  Regions will monitor compliance with the
amended federal SSUROs in accordance with Section 13 of the
Pesticides Inspection Manual.
  Please note that pursuant to the October 7, 1986 Compliance Strategy for the Emergency Suspension of
  Dinoseb, Regions/States were to have conducted inspections of registrants and producer establishments

  by November 7, 1986.

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Neutral Administrative Inspection Scheme (MAIS)	;	

     Inspections by the States of Washington, Idaho, and Oregon are
to be conducted at a minimum of 15 percent of the pesticide dealers
licensed to sell dinoseb and 15 percent of the growers who are
legally permitted-to use dinoseb.  In addition, Washington, Idaho,
and Oregon should ensure that growers who were previously permitted
to use dinoseb on snap beans and cucurbits are aware of the final
Dinoseb Cancellation Order and that they may no longer lawfully use
dinoseb on those crops.

ALLOCATION OF RESPONSIBILITIES

Office of Pesticide Programs (OPP)	

Will develop and provide to OCM a list of dinoseb pesticide
products that are registered for use on dry peas, lentils,
chickpeas, green peas, and caneberries.

Office of Compliance Monitoring (OCM)	

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

Will transmit the list of dinoseb products registered for use on
dry peas, lentils, chickpeas, green peas, and caneberries to the
Regions.

Will amend federal SSUROs, upon request by the registrants to
allow the sale, distribution, use, etc., of dinoseb products
registered for use on dry peas, lentils, chickpeas, green peas, and
caneberries in the States of Washington, Idaho, and Oregon.

Will authorize the sale, distribution, or shipment of dinoseb by
registrants, distributors, dealers, and users located in States
other than Washington, Idaho, and Oregon to licensed dealers in
those States.  Such authorization is contingent upon the
registrant, distributor, dealer, or user obtaining permission from
Washington, Idaho, or Oregon for shipment to their State.

Will notify the Regions of the registrants, distributors, dealer,
retailers, and users that have been given authorization to ship
dinoseb to Washington, Idaho, and Oregon.
           "2T*-»:- "
Will notify^EJj&gions of all SSUROs that have been amended by OCM.

Regions	.	

Will transmit the compliance Monitoring Strategy to the States.

Will transmit the list of dinoseb products to the States.

Will amend federal SSUROs in Washington, Idaho, Oregon, and other
States to allow sale, distribution, shipment, use, etc.,
consistent with the terms of the final Dinoseb Cancellation Order.

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                                -6-
Will inform States as to which dinoseb products have amended
federal SSUROs.

Will inform States of which registrants, distributors, dealers,
retailers, and users have been given authorization to ship dinoseb
to Washington, Idaho, and Oregon.

Will monitor compliance with the amended federal SSUROs in
accordance with section 13 of the Pesticides Inspection Manual.

Will report to OCM any enforcement actions taken by the Regions and
States in response to violations of the final Dinoseb Cancellation
Order, quarterly through FY 1990.

Will conduct inspections to assure compliance with the final
Dinoseb Cancellation Order at the registrant, producer, dealer,
distributor, retailer, and user levels, in States without
Cooperative Enforcement Agreements, as part of their routine
inspectional program.

Will take enforcement action, including issuing SSUROs, as
appropriate for violations of the Cancellation Order.

States	.	:	

Washington, Idaho, and Oregon will conduct inspections and respond
to reasonable tips and complaints to assure compliance with the
final Dinoseb Cancellation Order.

Washington, Idaho, and Oregon will take enforcement action as
appropriate.

Washington, Idaho, and Oregon will report to Region X on
enforcement actions taken in response to violations of the final
Dinoseb Cancellation Order, quarterly through FY 1990.

Washington, Idaho, and Oregon will amend any SSUROs, as necessary,
issued on their authority to distributors, dealers, retailers, and
users to permit the sale, distribution, and use of dinoseb products
pursuant to the terms and conditions of the final Dinoseb
Cancellation Order.

Washington, Idaho, and Oregon will provide permission, at their
discretion^£a registrants, distributors, dealers, retailers, and
users locate^in other States to ship dinoseb to licensed dealers
in their State for further sale, distribution, and use pursuant to
the final Dinoseb Cancellation Order.

States other than Washington, Idaho, and Oregon are to amend State
SSUROs, as necessary, at the distributor, dealer, retailer, and
user level to permit the sale, distribution and shipment of
dinoseb to licensed dealers in the States of Washington, Idaho, and
Oregon.

-------
States other than Washington, Idaho, and Oregon will conduct
inspections to assure compliance with the final Dinoseb
Cancellation Order at the registrant, producer, dealer,
distributor, retailer, and user levels, as part of their routine
inspectional program.
                         i
States other than Washington, Idaho, and Oregon will take
enforcement action, including issuing SSUROs,  as appropriate and
provided they have the authority, for violations of the
Cancellation Order.

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                    BEFORE THE ADMINISTRATOR            ^
              U.S. ENVIRONMENTAL PROTECTION AGENCY         \£.
                        WASHINGTON, D.C.                    * Q
                                                               \j
In the Matter of:                 )

Cedar Chemical Company et. al.     ) FIFRA Docket Nos. 590 et al.
                       CANCELLATION ORDER

     Pursuant to FIFRA section 6( b), 7 U.S.C. §136d(b), and 40

C.F.R. §§164.91 and 164.103, I hereby cancel all registrations

for pesticide products containing dinoseb (2-sec-butyl-4,6-

dinitrophenol) or any of its salts which have not already been

cancelled pursuant to the Notice of Intent to cancel which I

issued on October 7, 1986, and which was published at 51 FR

36650, October 14, 1986.  Except as provided below, it shall be

unlawful under FIFRA sections 12(a)(l)(A) and 12(a)(2)(K), 7

U.S.C. §§136j(a)(1)(A) and (a)(2)(K), for any person in any

State to distribute, sell, offer for sale, hold for sale,  ship,

deliver for shipment, or receive and (having so received)

deliver or offer to deliver to any person any pesticide product

containing dinoseb or any of its salts.

     Pursuant to FIFRA section 6(a)(l), 7 U.S.C. §136d(a)(l),

I have decided to permit distribution,  sale, and use of stocks

of cancelled dinoseb products: (1) for weed control in dry

peas, lentils, chickpeas, and green peas in the States of

Washington, Idaho, and Oregon during the 1988 use season,  and

(2) for vegetative cane control in caneberries (blackberries,

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                              -2-

boysenberries, loganberries, and raspberries) in the States of
Washington and Oregon during the 1988 and 1989 use seasons.
Such distribution, sale, and use will only be permitted in
accordance with the following procedures, terms, and conditions.
No cancelled dinoseb product shall be distributed, sold, or
used for any crop in any State without express written authoriza-
tion from the Assistant Administrator for Pesticides and Toxic
Substances (or his delegate).  The Assistant Administrator
shall authorize distribution, sale, and use of existing stocks
of dinoseb products for a particular crop in a particular State
only if the State Department of Agriculture expressly requests
in writing that such distribution, sale, and use be permitted,
and agrees to accept and enforce all procedures, terms, and
conditions set forth in, or adopted pursuant to, this Order.
     The following mandatory use restrictions shall be observed
by all persons using any cancelled dinoseb product pursuant to
this Order, shall constitute supplemental labeling for all
cancelled dinoseb products which may be used pursuant to this
Order, and shall take precedence over any inconsistent restrictions
or provisions on the prior labeling for such products:
     (1) Dinoseb shall not be applied at an application rate
         exceeding three pounds of active (a.i.) per acre for
         dry peas, chickpeas, and green peas/ one and one-half
         pound a.i. per acre for lentils, and two and one-half
         pounds a.i. per acre for caneberries.
     (2) Dinoseb shall not be applied by any one individual on
         any single day to more than a total of eighty (80)
         acres of dry peas, lentils, chickpeas, and green peas,
         or to more than twenty (20) acres of caneberries.

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                          -3-
 (3) No individual shall mix and/or load in one day more
     than the quantity of dinoseb required to treat the
     maximum permissible daily acreage for one crop at the
     maximum permissible application rate.

 (4) Only certified applicators may mix, load, or apply
     dinoseb; other persons, even if they are operating
     under the direct supervision of a certified applicator,
     shall not mix, load, or apply dinoseb.

 (5) All mixing and loadi-ng of dinoseb products must be
     done utilizing a closed system.

 (6) All persons must wear chemically resistant disposable
     coveralls and chemically resistant gloves and boots
     during mixing and loading of dinoseb,  while adjusting
     or repairing dinoseb application equipment, and during
     application of dinoseb to caneberries.

 (7) Closed tractor cabs equipped with positive pressure
     ventilization must be used for application of dinoseb
     to dry peas,  lentils, chickpeas, and green peas.
     Applicators must remove protective coveralls and gloves
     worn during mixing and loading immediately before
     entering a closed tractor cab in order to avoid cab
     contamination, and must carry an unused set of coveralls
     and gloves in the cab, for use in the  event in-field
     repair,  maintenance, or adjustment of  equipment is required,

 (8) Aerial application of dinoseb is prohibited.   Dinoseb
     may only be applied utilizing tractor  drawn equipment.

 (9) Dinoseb may only be applied to caneberries as a low-
     pressure directed spray for vegetative cane (primocane)
     control.

(10) Application of dinoseb is prohibited when wind conditions
     exceed ten miles per hour.

(11) No person shall re-enter any field treated with dinoseb
     for any purpose within one week of application unless
     that person is within a closed cab,  or is wearing
     chemically resistant disposable coveralls and chemically
     resistant gloves and boots.   Any person required to re-
     enter a field treated with dinoseb within one week of
     application shall be notified that the field was
     treated with dinoseb and advised to avoid dermal
     contact with treated foliage and soil.

-------
                              -4-

     The following mandatory restrictions shall govern any

distribution or sale of cancelled dinoseb products pursuant to

this Order:

     (1) No cancelled dinoseb product may be distributed or
         sold for use on any crop unless: (1)  the product
         was registered, packaged,  and labeled on October 7,
         1986,  or (2) the product was manufactured from stocks
         of  a registered technical  dinoseb product which were
         packaged and labeled,  and  in the possession of the
         manufacturer,  on or before October 7, 1986.

     (2) No cancelled dinoseb product may be distributed or
         sold for use on dry peas,  lentils, chickpeas, or green
         peas unless the product was previously labeled for use
         on  peas, lentils, or chickpeas.   No cancelled dinoseb
         product may be distributed or sold for use on caneberries
         (blackberries, boysenberries, loganberries, and
         raspberries) unless the product  was previously labeled
         for use on one or more of  these  crops.

     (3) Only pesticide dealers licensed  by the State in question
         may distribute or sell cancelled dinoseb products,

     (4) Each container of a cancelled dinoseb product which is
         distributed or sold must be accompanied by supplemental
         labeling including all of  the use restrictions set
         forth above, and a warning stating (1) that the product
         poses a hazard to unborn children and that all reasonable
         efforts should be made to  prevent exposure of women of
         child-bearing age, (2) that the  product also poses
         hazards to male reproduction, (3) that the product is
         acutely toxic, and (4) that the  product may only be
         applied by certified applicators.

     (5) Dealers may sell dinoseb only to growers who may
         legally use the product pursuant to this Order, and
         no  grower shall be permitted to  purchase a quantity
         greater than that required to treat the grower's
         eligible crop acreage  at the maximum permissible
         application rate.  All stocks of dinoseb already in a
         grower's possession must be taken into account when
         determining the quantity of dinoseb a grower may law-
         fully purchase.

     (6) Dealers must obtain and record the following information
         prior to selling, distributing,  or delivering any
         dinoseb product:

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                              -5-
          (a) The grower's name, address, and certification
              number (if any),
          (b) The type of crop and number of acres to be
              treated,
          (c) The name, address, and certification number of
              the person(s) who will mix, load, and apply the
              dinoseb,
          (d) The quantity of dinoseb already in the grower's
              possession,
          (e) The product name(s) and registration number(s) of
              the dinoseb product(s),
          (f) The quantity of the dinoseb product(s) to be
              sold, distributed, or delivered.

     All such information shall be forwarded by the dealer to
     the State Department of Agriculture and the EPA regional
     office within five days following sale, distribution, or
     delivery.

     The Assistant Administrator for Pesticides and Toxic

Substances,  in consultation with the Regional Administrator

and the Departments of Agriculture of the States of Washington,

Oregon, and Idaho, shall establish procedures for monitoring

and enforcement by the States of the restrictions on sale,

distribution, and use imposed pursuant to this Order.   The

Assistant Administrator (or his delegate) may also authorize

(1) sale, distribution, or shipment of existing stocks of

cancelled dinoseb products by registrants,  distributors, dealers,

or end-users located in other States to dealers in the States

of Washington, Oregon,  and Idaho, when sale of existing stocks

by the recipient dealer is permitted pursuant to this Order,

and (2) any shipments of any cancelled dinoseb product which

are necessary to facilitate proper storage or disposal of such

products.  This Order constitutes final Agency action in the

-------
                              -6-


above-captioned proceeding under FIFRA sections 6(b) and 16(b),

7 U.S.C. SSl36d(b) and 136n(b), and is a final cancellation

order under 40 C.F.R. S164.130.
                                      Lee M. Thomas
                                      Administrator
Dated:
                  ^

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            UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                        WASHINGTON. 0 Z. 20460
                            MAR   3 1989
                                                  -> -: s r. c o E s -»,-. a T 3 x • c i 'j 9 •=
MEMORANDUM

SUBJECT



FROM:
           Compliance Monitoring of the June 9, 1933 Dinoseb
           Cancellation Order for the 1989 Growing Season

           Michael F. Wood, Qirector\\^JLvjtJ>\-(*J
           Compliance Division
TO:
          Phylli s E.  Flaherty •}
          Acting  Director
          Policy  and  Grants  Division

          Addressees
     The purpose of this memorandum is to clarify that the
June 9, 1983 Final Dinoseb Cancellation Order and the June 15,
1938 Compliance Monitoring Strategy for the Final Cancellation
of Dinoseb are in effect, and to provide you with the procedures
for amending Stop Sale, Use, or Removal Orders  (SSUROs).

     The Office of Compliance Monitoring (OCM)  issued a Compliance
Monitoring Strategy for the Final Cancellation  of Dinoseb on
June 15, 1988.  However, on June 17, 1988, the  U.S. District
Court Judge of Oregon, Judge Redden, issued an  order which
temporarily stayed the effectiveness of the June 9, 1988 Final
Dinoseb Cancellation Order.  As a result, OCM issued a memorandum
on June 21, 1988 which instructed the Regions not to implement
the June 15, 1988 Compliance Monitoring Strategy.  On October 4,
1988,  Judge Redden granted EPA's motion for a summary judgement
and reversed his previous decision.  The result of this ruling
is that the June 9, 1983 Final Dinoseb Cancellation Order was
reinstated.  The Office of Compliance Monitoring will inform
the Regions of any additional rulings that may  affect the status
of dinoseb products.   However, since the June 9, 1988 Final
Dinoseb Cancellation Order is currently in effect, Regions and
States are to assure compliance with that order in accordance
with applicable provisions of the June 15, 1988 Compliance
Monitoring Strategy for the Final Cancellation  of Dinoseb.

-------
                              -2-
     The June 9, 1988 Final Dinoseb Cancellation Order permits
the sale, distribution, and use of existing stocks of dinoseb
for vegetative control in  caneberries (blackberries, boysenberries,
loganberries, and raspberries) in the States of Washington and
Oregon during the 1939 growing season.  As stated in the June 15,
1933 strategy, the procedures for amending Stop Sale, Use, or
Removal Orders (SSUROs) to allow sale, distribution, and use
of cancelled dinoseb products in accordance with the cancellation
order are found on page 2  of  the March 14, 1938 memorandum from
John J. Neylan III regarding  FIFRA Section 13's for Dinoseb
(attached).  The procedures set out in the March 14, 1988
.Tiemorandum, that were used in the 1983 growing season, will be
used this year as well (see Attachment A).

     If you have any questions regarding this memorandum, or
the attached June 15, 1988 Compliance Monitoring Strategy for
the Final  Cancellation of  Dinoseb, please contact Dan Helfgott
in the Policy and Grants Division at FTS 382-7825.  Questions
on the procedures for amending SSUROs may be directed to
John Mason of the Compliance  Division at FTS 382-7835.


Attachments

-------
 II
 III
fcrv
 v
 VI
 VII
 VIII
 IX
 x
 CC:
         Douglas  D. Campt
         Edwin F. Tinsworth
         Anne  Lindsay
         Frederick F. Stiehl
         Mark  Greenwood
         A.E.  Conroy II
         Connie Musgrove
         Ken Shiroishi
         Jack  Neylan
         Phyllis  Flaherty
         Mike  Wood
         Jerry Stuhbs
         Maureen  Lydon
         Jan Bearden
         Bob Zisa
         Ken Kanagalingam
                     (TS-766C)
                     (TS-767C)
                     (TS-767C)
                     (LE-134A)
                     (LE-132A)
                     (EN-342)
        Jake Mackenzie
        Western Regional Compliance Director
Louis F. Gitto, Director
Air Management Division

Barbara Metzger, Director
Environmental Services Division
            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      Phyllis Reed, Chief
Environmental Services Division  Pesticides & Toxic Substances Br
William B. Hathaway, Director
Air, Pesticides & Toxic Div

William  A. Spratlin, Director
Air and Toxics Division

Irvin L. Dickstein, Director
Air and Toxics Division

David P. Howekamp, Director
Air Management Division

Gary O'Neal, Director
Air and Toxics Division

Chris Kirby
Oregon Dept. of Agriculture

Art Losey
Washington Dept. of Agriculture
             Robert Murphy,  Chief
             Pesticides  & Toxic  Substances  Br

             Leo Alderman, Chief
             Pesticides  & Toxic  Substances  Br

             Alvin Yorke, Chief
             Toxic Substances Branch

             Davis Bernstein, Chief
             Pesticides  & Toxics Branch

             Kenneth Feigner, Chief
             Pesticides  & Toxic  Substances Br

             Rod Awe
             Idaho Dept. of Agriculture

             Vivan Jennings
             U.S.  Dept.  of Agriculture
Michael Walker
Jim Roeloffs
John Tice
(LE-134P)
(TS-788)
(TS-766C)

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           UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                       WASHINGTON, D.C. 20460
                            flAR  I Z 1990
                                                  PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM
SUBJECT:  EBDC Compliance Monitoring Strategy
TO:
                                                  n
                                        '
                                                  »I  i
FROM:     John J. Neylan  III, D i recto r\L\M>^^^}fy()*s**^'
          Policy and Grants Division   X       (j  vJ
          Office of Compliance MonitorlYig  (EN-J32)
          Addressees
     Attached is the Compliance Monitoring Strategy for the
Cancellation and Registration Amendments for Pesticide Products
Containing EBDCs.  We appreciate the comments submitted on the
December 18, 1989 draft of this strategy.  We have  incorporated
most of these comments into the attached strategy.  We have also
incorporated the additional EBDC actions that have been requested
by the registrants and accepted by the Agency since the draft
strategy was sent out for comment.
     The EBDC
compliance in
that affected
in violation
strategy also
with the EBDC
inspections.
also included
products, the
              strategy calls for Regions/States to conduct
             spections at EBDC producing establishments to assure
              EBDC fungicides are not being sold or distributed
             of the cancellations and amended registrations.  The
              calls for Regions/States to check for compliance
              actions  in the marketplace as part of their routine
              A summary of the strategy  is attached.  We have
              an appendix which  lists all of the affected
              actions taken, and the existing stocks deadlines.
     Please transmit the strategy and summary to the States
within your Region.  If you have any questions on the attached
EBDC strategy, please contact Dan Helfgott of my staff at FTS
475-7376.
Attachments

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                           ADDRESSEES
 Douglas D. Campt
 Edwin F. Tinsworth
    e Lindsay
  rederick F. Stiehl
 Mark Greenwood
 A. E. Conroy II
 Connie Musgrove
 John J.  Neylan III
 David Dull
 Mike Wood      :
 Phyllis Flaherty   •
 Jerry Stubbs
 Maureen Lydon
 Ken Kanagalingam
 Bob Zisa
 Sherry Sterling
 Jan Bearden
(TS-766C)
(TS-767C)
(TS-767C)
(LE-134A)
(LE-132A)
(EN-342)
   it
   it
   ii
   ii
   ii
   it
   it
   ii
   ii
 Jake Mackenzie
 Western Regional Compliance Director

I     Marvin Rosenstein, Chief
      Pesticides & Toxic Substances Br

II    Ernest Regna, Chief
      Pesticides & Toxic Substances Br

III   Larry Miller, Chief
      Toxic & Pesticides Branch

IV    Richard D. Stonebraker,  Acting Chief
      Pesticides & Toxic Substances Br

V     Phyllis Reed, Chief
      Pesticides & Toxic Substances Br

VI    Robert Murphy, Chief
      Pesticides & Toxic Substances Br
VII   Leo Alderman, Chief
      Pesticides & Toxic Substances Br

VIII  Alvin Yorke, Chief
      Toxic Substances Branch

IX    Davis Bernstein, Chief
      Pesticides & Toxics Branch

X     Kenneth Feigner, Chief
      Pesticides & Toxic Substances Br
                         ; 8.
cc:   Michael Walker
      John Fleuchaus
      John Tice
      Artie Williams
      Phil Ross
     (LE-134P)
     (TS-788)
     (TS-769C)
     (H-7508C)
     (LE-132A)

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               SUMMARY OF THE  EBDC  COMPLIANCE MONITORING STRATEGY
o      Ethylene bisdithiocarbamates  (EBDCs) are a group  of pesticides used  to control fungi  on a
       wide variety of fruits, vegetables, ornamental plants, turf grasses, and industrial  sites.  The
       EBDC fungicides include  mancozeb, maneb,  metiram,  nabam, and  zineb.

MANEB.  METIRAM. AND MANCOZEB

o      The  four technical registrants of EBDCs (DuPont, Pennwalt, Rohm  & Haas,  and BASF)  have
       amended the registrations for their maneb, metiram, and mancozeb  products to delete  42 food
       crops from most  of  their  technical and  end-use labels.  Thirteen crop sites will remain.

           In separate actions, Rohm and Haas has cancelled its  maneb  registrations,  and  three other
           registrants have  amended their EBDC registrations consistent with the actions taken  by the
           four technical registrants.

o      As of January 1990, the four technical  registrants must relabel all of  their affected  technical
       and end-use maneb, metiram, and mancozeb products  not  in the possession of  the  growers to
       reflect  the  deletion of the 42 crops.

           However, due to an error in  the  Federal Register Notice,  EPA will not enforce label
           changes required on Pennwalt's  maneb and mancozeb  products  until after the effective  date
           of the  revised Federal Register  Notice.
o      Rohm and Haas  (the sole registrant  holding nabam  agricultural food uses)  has amended the
       registrations of their nabam product registrations to  delete agricultural food uses.   Remaining
       uses  on nabam labels are  for use on ornamental plants  and industrial sites.

ZINEB

o      Micro-Flo Company, the sole  registrant of zineb technical product,  has  cancelled its zineb
       registrations.   Sixteen other registrants have voluntarily cancelled their zineb products  as  well.
       Two  other registrants have deleted zineb as an active ingredient.  The effective dates for the
       zineb registration amendments and cancellations are  listed in Appendix  A of the strategy.

INSPECTIONS

o      Regions/States are to conduct inspections at the EBDC pesticide producing establishments to
       assure compliance with  the cancellations and to  assure that the affected EBDC fungicides are
       being sold  and distributed  with  the revised labeling required by the amended registrations.

o      Inspections at the EBDC registrants'  producing establishments are to be completed by June 1,
       1990.  Regions/States must report to  HQ  on registrant violations discovered.

       Regions/States are to check for compliance in the marketplace as part  of their routine
       inspection targeting to assure  compliance with the cancellations  and amended registrations.

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  50020
Federal Register / Vol. 64. No. 291 / Monday. December  4. 1989  / Notices
  viewing at all EPA Libraries and in the  *
 ^PA RCRA Docket (M2427). U.S.
 Environmental Protection Agency, 401 M
 Rtreet SW., Washington. DC 20460 from
  9:00 a jn. to 4:00 p.nu Monday thru
  Friday, excluding Federal Holidays, by
  appointment only. Appoi