&EPA
United States    .   Preyentiqn, Pesticides   EPA 738-R-99-S Olo
Environmental Protection  And Toxic Substances   November 1999
Agency	(7508C)	
Reregi strati on
Eligibility Decision (RED)

CAPTAN

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                 United States
                 Environmental Protection
                 Agency	
                      Prevention, Pesticides
                      And Toxic Substances
                      (7508C)
EPA-738-F99-015
September 1999
                 R.E.D.   FACTS
                CAPTAN
     Pesticide
Reregistration
   Use Profile
         All pesticides sold or distributed in the United States must
 be registered by EPA, based on scientific studies showing that they
 can be used without posing unreasonable risks to people or the
 environment. Because of advances in scientific knowledge, the law
 requires that pesticides which were first registered before November
 1, 1984, be reregistered to ensure that they meet today's more
 stringent standards.
     In evaluating pesticides for reregistration, EPA obtains and
 reviews a complete set of studies from pesticide producers,
 describing the human health and environmental effects of each
 pesticide. To implement provisions of the Food Quality Protection
 Act of 1996 (FQPA), EPA considers the special sensitivity of infants
 and children to pesticides, as well as aggregate exposure of the
 public to pesticide residues from all sources, and the cumulative
 effects of pesticides and other compounds with common
 mechanisms of toxicity. The Agency develops any mitigation
 measures or regulatory controls needed to effectively reduce each
 pesticide's risks.  EPA then reregisters pesticides that meet the
 safety standard of the FQPA and can be used without posing
 unreasonable risks to human health or the environment.
    When a pesticide is eligible for reregistration, EPA explains the
 basis for its decision in a Reregistration Eligibility Decision (RED)
 document. This fact sheet summarizes the information in the RED
 document for reregistration case 0120, captan.

    Captan is a fungicide used to control diseases on orchard
 crops, seed treatments, ornamentals, lawns and turf, and is also
 used as an in-can preservative  in adhesives and paint. Formulations
 include dust, emulsifiable concentrate, flowable concentrate, water
dispersible granules, wettable powder, and a variety of others.
    Captan is applied by sprayers, chemigation equipment, power
duster, liquid seed treater, paintbrush, tank-type sprayers, and other
application methods. Captan is also applied as a post-harvest dip to
apples, cherries and pears.

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               Regulatory
                   History
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           Human Health
             Assessment
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                       Captan was first registered as a pesticide in the U.S. in 1951.
                  EPA published the August 18, 1980 Notice of Rebuttable
                  Presumption Against Reregistration (RPAR) because it had
                  determined that captan exceeded certain risk criteria.  The RPAR
                  Notice was triggered by the Agency's receipt of data demonstrating
                  that captan could induce oncogenic effects in experimental mammals
                  (mice and rats).
                       Th§ Agency issued a Registration Standard for captan in March
                  1986. The captan Registration Standard identified the data gaps
                  required to be satisfied in order to continue the existing registration.
                  AJ988 Data Call-in Notice required the^submission of additional
                  toxicity data.
                       EPA published the Position Document (PD4) "Captan; Intent To
                  Cancel Registrations; Conclusion of Special Review" (54FR8116) on
                  February 24, 1989. This notice announced the conclusion of EPA's
                  Special Review and risk/benefit analysis of captan  registrations.
                  EPA evaluated  additional data received and issues raised received
                  during the Special Review process and decided to  allow the
                  continued registration of the following uses: all non-food uses, seed
                  treatments, and certain food uses listed in the PD4 ^almonds, apples,
                  apricots, blackberries, blueberries, celery plant-beds, cherries,
                  dewberries, eggplant plant-beds, grapes, green onions, lettuce,
                  mangoes, nectarines, peaches, post-harvest pears, pepper plant-
                  beds, pimento plant-beds, plums/prunes, raspberries, spinach piant-
                  beds, strawberries, taro and tomato plant-bedsj.  The Notice
                  canceled all other uses.       ' 	^  '  ""/,,"	,  '	'.      .  ^       .,,,",'..,.
                       Currently, 158 captan products are registered, of which nine are
                  jrianufacturing-use products.  Two technical registrants, Tomen Agro,
                  Inc. and Makhteshim-Agan of North America, are members of the
                  Captan Stewardship Task Force.
Toxicity            i       "  '     i      ^        ^        '' ^
     The human health risk assessment evaluated toxicological and
exposure data to develop dietary, drinking water, residential,
aggregate and occupational exposure analyses, and to assess the
adequacy of existing tolerances. Because the available studies
demonstrated no indication of increased sensitivity of animals to in
uteroor postnatal exposure to captan and the "database is complete,
the Agency determined that there is no evidence of special sensitivity
to infants and children. Therefore, the FQPA Safety Factor was
remdvM (reduced to 1X) for captan and the RfD equals the PAD.
     The developmental endpoint in rabbits, with a NOAEL of 10
mg/kg/day, was selected for the acute Reference Dose and the
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 short- and intermediate-term dermal risk assessments.  A three-
 generation reproduction study in rats is the basis for the chronic RfD.
 The NOAEL in the study was 12.5 mg/kg/day.  Captan is severely
 irritating to the eyes and is classified in the Toxicity Category I.
      Captan is severely irritating to the eyes, and classified in
 Toxicity Category I based on corneal opacity in a rabbit study.
 Captan has been classified as a B2 probable human carcinogen,
 based on increased incidence of intestinal tumors in mice and rats.
 To estimate human cancer risks, the Agency used a linear, low dose
 extrapolation approach for captan. Based on intestinal tumors in
 mice, a Q1 * of 2.4x10'3 (mg/kg/day)-1 was calculated.

 Dietary Exposure
     EPA has assessed the acute and chronic dietary risk posed by
 captan, considering food and water sources of potential residues.
 Residues of captan plus the metabolite THPI were included in the
 anticipated residues for chronic (non-cancer) exposure and acute
 exposure in meat and milk.
     To determine the risk from captan in foods, the Agency
 conducted acute, chronic (non-cancer) and chronic (cancer) dietary
 analyses. The acute analysis used a probabilistic dietary  risk
 assessment estimated and the chronic dietary exposure was
 assessed using refinements such as anticipated residues and
 percent crop treated information.  Since THPI is not considered
 carcinogenic, the cancer risk assessment considered only the
 residues of captan perse.
     The Agency has reassessed captan food and feed tolerances
 under the standards of FQPA. Crop group tolerances are being
 established for various groups of related vegetables. Many of these
 tolerances support seed treatment only, as the foliar applications
 have not been  permitted since the PD4 was issued in 1989. The
 crop subgroup tolerance for caneberries (raspberries and
 blackberries) is being established to support Special Local Needs
 registrations in Oregon, Ohio,  Pennsylvania, South Carolina, and
 Washington.

 Occupational  and  Residential Exposure
     For occupational risk,  different routes of exposures are
 considered.  As mentioned  previously, captan is severely irritating to
the eyes, and for dermal exposure, a dermal absorption rate of
 0.4%/hour was selected. The assessments also assume that captan
 is taken up through the inhalation pathway to the same degree as
oral ingestion.

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                   Residential exposure to captan residues can occur by dermal
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              and inhalation roufes.  Also, postapplication residential dermal
              exposure is expected from gardening and lawn activities on captan
              treated areas. The Agency is concerned about postapplication
              exposure to toddlers hand-to-mouth activity on treated lawns. The
              registrant has agreed to voluntarily cancel this use. Captan is also
              incorporated in paints and adhesives. Homeowner use of captan
              containing paints and adhesives do not result in a risk concern to the
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       TJie human health risk assessment evaluated toxicological and
  residue data, and included dietary, drinking water, aggregate,
 '^sjdeiitia^ and occupational  exposure^ as required by FQPA. The
  FQPASafety Factor was removed as there Is rio evidence that there
  is increased sensitivity to infants and children from exposure to
  captan, and the database is complete for evaluating FQPA concerns.
       An gcute probabilistic dietary risk assessment estimated that
  acute dietary exposure to be  36% of the acute population adjusted
  dose (aPAD) at the 99.9th percentile. The chronic non-cancer
  dietary risk from exposure to  captan is  <2% of the chronic population
  adjusted dose (cPAD). The upper bound dietary cancer risk for the
  USS. population is 1.3 x 10"7, which is below the Agency's level of
  concern for lifetime excess cancer risk. The Agency has also
  determined that there is no risk concerp frprri the consumption of
  captan residues in drinking water.
       The Agency has also examined aggregate risk.  These
  assessments take into account available information concerning
  exposures from the pesticide  residue in food and all other exposures
  for which  there is reliablei information including pesticide residues in
  drinking water, exposure from pesticides uses in and around the
  hqme, and exposure in non-residential  settings such as, parks and
'' schools.  _ ., /    j i	 115    ,     . 	„   ,A	|,iu. .
       Residential exposure to captan may occur either during or after
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  a captan application to home  gardens,  ornamental flowers, shrubs, or
  seeds. 'Exposure may also occur to golfers from treated golf
  courses.  Because of concern about toddlers exposed to treated
  lawns, the technical registrants have agreed to voluntarily cancel
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  these uses.  For all other residential uses, exposure and risks do not
  exceed the Agency's level of  concern^
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       T^he Agency has determined that acute and chronic dietary
  "(food and water) and cancer aggregate risks are hot of concern
  Residential exposure from the use of captan around the home does
  not exceed the Agency's level of concern when aggregated with  food
  and drinking water exposure.

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Environmental
  Assessment
                        For occupational scenarios, most risk estimates were well
                   above 100 (values below 100 are a concern for captan) with cancer
                   risks ranging from 1.3 x 10'5 to 1.7 x 10'9.  No additional mitigation is
                   required to address occupational cancer risks. There is a concern
                   for mixers and loaders of wettable powder for the aerial application of
                   captan.  The Agency believes that this risk will be adequately
                   mitigated by requiring water soluble bags or a suitable reduction in
                   application rate. Reentry Intervals were also reevaluated during the
                   RED process and new REIs are being established ranging from 12-
                   hours for seed treatment uses to 4-days for ornamentals.
                        The Agency is aware of a proposed common mechanism of
                   carcinogenicity between captan and folpet, which implicates their
                   common metabolite, thiophosgene.  Because thiophosgene is so
                   highly reactive in animal systems, its residues cannot be scientifically
                   quantified.  Without measurable residues of the common metabolite,
                   it is difficult to relate exposures of captan to those of folpet since the
                   rate of thiophosgene formation may be different for both compounds.
                   The Agency has conducted a conservative aggregate assessment
                   for thiophosgene, assuming that it may cause cancer through both
                   captan and folpet, and has determined that this conservative risk is
                   not of concern.
                        The FQPA also directed the Agency to develop an Endocrine
                   Disrupter Screening Program, which was published in the Federal
                   Register of December 28, 1998 (63 FR 71541).  The Program uses
                   a tiered approach and anticipates issuing a Priority List of chemicals
                   and mixtures for Tier 1 screening in the year 2000. As the Agency
                   proceeds with implementation of this program, further testing of
                   captan and end-use products for endocrine effects may be required.
Environmental Fate
Captan dissipates rapidly in the environment, with a half-life of less
than 1 day, based on the results of hydrolysis and aerobic soil
studies. Parent captan is slightly mobile to relatively immobile in
various soils.  The major degradates, THPI and THPAm, appear to
be mobile in soil. Though these degradates have the potential to
reach ground  and surface water, they are not expected to be
persistent.
                  Ecological Effects
                       For ecological risk, only acute toxicity to freshwater fish is of
                  concern. There are no reported fish kills. Additionally, the Agency
                  has determined that captan is:  practically nontoxic to avian species,
                  both on an acute and subacute basis; not acutely toxic to mammals,

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                        and relatively nontoxic to insects. Terrestrial and aquatic plant
                        toxicity is not a concern.  Both THPI and THPArn were found to be
                        non-toxic to fish species tested.  The Agency is requiring a 96-hour
                        oyster shell deposition study, However, these data are considered
                        confirmatory and are not expected to change the conclusions of this
                        risk assessment.
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                             To  reduce the risks posed by captan, the Agency is requiring
                        the fo|lowing mitigation measures for captan-containing products:
                             f    Voluntary cancellation' of the residential turf use;
                                  Water-soluble packaging for the wettable powder
                                  formulation used aerially
                                  Various Personal  Protective Equipment, including
                                  chemical-resistant gloves, aprons/coveralls, eye
                                  protection,  and dust/mist respirators;
                                  Revised labeling to reduce the risks to non-target aquatic
                        . ,	 . •.	|.  . organisms;
                                  Eye wash stations for  occupational field workers; and
                             -    Double notificatipn for workers entering treated fields.
          Additional .Data,
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                                   EPA is requiring the following additional generic studies for
                              captan to confirm its regulatory assessments and conclusions: the
                                   '	  "  ' shelfjdepositioji"studyi72-3(bjj Acute	'	'
                                                      - Mpllusk; 81-1 Acute Oral Toxicity (rat);
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                                  ^	8752400 Dermal Exposure; 875.2500 Inhalation Exposure;
                              pVoduct-specific data including ^rpd^uct'chemjstry,'revised
                              Confidential Statements of Formula (CSFs), and revised labeling for
                              reregistration. These data are considered to be confirmatory and are
                              not expected to change the conclusions of this RED.
        Product Labeling
      Changes Required
                                   All captan end-use products must comply with EPA's current
                              pesticide product labeling requirements and with the following. For a
                              comprehensive list of labeling requirements, please see Section V of
                              the captan RED document.
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                       EPA has determined that products containing captan are
                  eligible for reregislration, except for those with uses on turf and
                  aerially-applied wettable powder formulations. Products applied to
                  turf at soc! farms or golf courses are eligible for reregistration; uses at"
                  all other turf sites are being voluntarily canceled.  Wettable powder
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   For More
Information
               formulations that are applied aerially are eligible for reregistration,
               provided either: 1) the products are packaged in water soluble
               packaging; or 2) the application rates are reduced to a level that is no
               higher than 1.2 Ib ai/A. The use of eligible captan products in
               accordance with labeling specified in this RED will not pose
               unreasonable adverse effects to humans or the environment.  These
               products will be reregistered once the required confirmatory generic
               data, product specific data, CSFs, and revised labeling are received
               and accepted by EPA. Products which contain active ingredients in
               addition to captan will be reregistered when all of their other active
               ingredients also are eligible for reregistration.
     EPA is requesting public comments on the Reregistration
 Eligibility Decision (RED) document for captan during a 60-day time
 period, as announced in a Notice of Availability published in the
 Federal Register. To obtain a copy of the RED document or to
 submit written comments, please contact the Pesticide Docket,
 Public Information and Records Integrity Branch, Information
 Resources and Services Division (7502C), Office of Pesticide
 Programs (OPP), US EPA, Washington, DC 20460, telephone
 703-305-5805.
     Electronic copies of the RED and this fact sheet are available
 on the Internet. See http://www.epa.gov/REDs.
     Printed copies of the RED and fact sheet can be obtained from
 EPA's  National Center for Environmental Publications and
 Information (EPA/NCEPI), PO Box 42419, Cincinnati, OH  45242-
 2419, telephone1-800-490-9198; fax 513-489-8695.
     Following the comment period, the captan RED document also
 will be available from the National Technical Information Service
 (NTIS), 5285 Port Royal Road, Springfield, VA22161, telephone
 703-605-6000.
     For more information about EPA's pesticide reregistration
 program, the captan RED, or reregistration of individual products
 containing captan, please contact the Special Review and
 Reregistration Division (7508C), OPP, US EPA, Washington, DC
 20460, telephone 703-308-8000.
     For information about the health effects of pesticides, or for
 assistance in recognizing and managing pesticide poisoning
 symptoms, please contact the National Pesticide
Telecommunications Network (NPTN) toll-free at 1-800-858-7378.
Their Internet address is ace.orst.edu/info/nptn.

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   SB.
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                WASHINGTON, D.C. 20460
                                                                    OFFICE OF
                                                          PREVENTION, PESTICIDES
                                                           AND TOXIC SUBSTANCES
 CERTIFIED MAIL
                                                               NOV - 2 1999
Dear Registrant:

       I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case #0120 which includes
the active ingredient captan. The enclosed Reregistration Eligibility Decision (RED), which was
approved on September 30,1999, and contains the Agency's evaluation of the data base of these
chemicals, its conclusions of the potential human health and environmental risks of the current
product uses, and its decisions and conditions under which these uses and products will be eligible
for reregistration. The RED includes the data and labeling requirements for products for
reregistration. It may also include requirements for additional data (generic) on the active
ingredients to confirm the risk assessments.

       To assist you with a proper response, read the enclosed document entitled "Summary of
Instructions for Responding to the RED." This summary also refers to other enclosed documents
which include further instructions. You must follow all instructions and submit complete and
timely responses. The first set of required responses is due 90 days from the receipt of this
letter.  The second set of required responses is due 8 months from the date of this letter.
Complete and timely responses will avoid the Agency taking the enforcement action of suspension
against your products.

       Please note that the Food Quality Protection Act of 1996 (FQPA) became effective on
August 3,1996, amending portions of both pesticide law (FIFRA) and the food and drug law
(FFDCA). This RED takes into account, to the extent currently possible, the new safety standard
set by FQPA for establishing and reassessing tolerances. However, it should be noted that in
continuing to make reregistration determinations during the early stages of FQPA implementation,
EPA recognizes that it will be necessary to make decisions relating to FQPA before the
implementation process is complete. In making these early case-by-case decisions, EPA does not
intend to set broad precedents for the application of FQPA.  Rather, these early determinations
will be made on a case-by-case basis and will not bind EPA as it proceeds with further policy
development and any rulemaking that may be required.

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                      If EPA determines, as a result of this later implementation process, that any of the
               determinations described in this RED are no longer appropriate, the Agency will pursue whatever
               ac|ipr| may be appropriate, including but not limited to reconsideration of any portion of this
             1  RED.	"	:   " "'	'	'	    	"   '	
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                      If you have questions on the required generic data requirements or wish to meet with the
               Agency on specific decisions made in the RED, please contact the Special Review and
               Reregistration Division representative Kylle Rothwell at 703-308-8055. Address any questions
               on product specific data requirements or specific changes required to the Special Review and
               Reregistration Division representative Karen Jones at 703-308-8047.
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                                                                       Special Review anc
                                                                        Reregistration Division
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               SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
               THE REREGISTRATION ELIGIBILITY DECISION
 1 •  DATA CALL-IN (PCD OR "90-DAY RESPQNSE"-If generic data are required for
 reregistration, a DCI letter will be enclosed describing such data. If product specific data are
 required, a DCI letter will be enclosed listing such requirements. If both generic and product
 specific data are required, a combined Generic and Product Specific DCI letter will be enclosed
 describing such data.  However, if you are an end-use product registrant only and have been
 granted a generic data exemption (GDE) by EPA, you are being sent only the product specific
 response forms (2 forms) with the RED. Registrants responsible for generic data are being sent
 response forms for both generic and product specific data requirements (4 forms). You must
 submit the appropriate response forms (following the instructions provided) within 90 days
 of the receipt of this RED/DCI letter; otherwise, your product may be suspended.

 2._  TIME EXTENSIONS AND DATA WAIVER REOUESTS-No time extension requests
 will be granted for the 90-day response. Time extension requests may be submitted only with
 respect to  actual data submissions. Requests for time extensions for product specific data should
 be submitted in the 90-day response. Requests for data waivers must be submitted as part of the
 90-day response. All data waiver and time extension requests must be accompanied by a full
justification. All waivers and time extensions must be granted by EPA in order to go into effect.

 3 APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
 submit the following items for each product within eight months of the date of this letter
 (RED issuance date).

       a-  Application for Reregistration (EPA Form 8570-1). Use only an original application
 form. Mark it "Application for Reregistration." Send your Application for Reregistration (along
 with the other forms listed in b-e below) to the address listed hi item 5.
       b- Five copies of draft labeling which cnmpHftg with the T?FP>
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregistration. For further labeling
guidance, refer to the labeling section of the EPA publication "General Information on Applying
for Registration in the U.S., Second Edition, August 1992" (available from the National Technical
Information Service, publication #PB92-22 1811; telephone number 703-605-6000).

       c. Generic or Product Specific Data. Submit all data in a format which complies with
PR Notice 86-5, and/or submit citations of data already submitted and give the EPA identifier
(MRID) numbers. Before citing these studies, you must make sure that they meet the
Agency's acceptance criteria (attached to  the DCI).

       d. Two copies of the Confidential Statement of Formula (CSF> for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must

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3!
 comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
 You have two options for submitting a CSF: (1) accept the standard certified limits (see 40 CFR
 § 158.175) or (2) provide certified limits that are supported by the analysis of five batches. If you
 choose the gecond option, you must submit or cite the data for the five batches along with a
 cei--tijfipatioa                                        A copy of the CSF is enclosed;
 follow the instructions on its back.
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      "& CJertLfication With Respect to Citation of Data. Complete and sign EPA form 8570-
 34 and 8570-35 for each product.

,,4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments  	  "' ^'
 pertaining to the content of me RED may be submitted to the address shown in the Federal
 Register Notice which announces the availability of this RED.
|'{!i "":	; !ff. ,'l!^l  ,S\,.''  .;, ,•! ,	,'	•;*'•.', I'1   ;: "I",  if"!  /	  ;J:  ;•*,  .;|1.' ,i"'.l" '  "
 51 'WBDERE TO 'SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
 APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES^

 BvU.S.Maii:

      Document Processing Desk (RED-SRRD-PRB)
      Office of Pesticide Programs (7504C)
      EPA, 401 M St. S.W.
      Washington, D.C. 20460-006l

 By express;
                  Offiee QfPesticide Programs (7504C)
                  Room 266A, Crystal Mall 2
                                    '
            :•;. > ...... Arlipgton,VA 22202

            |, ..... EPA'S ii^VJEWS--EPA will screen all submissions for completeness; those which are not
            complete will be returned with a request for corrections. EPA will try to respond to data waiver
            and time extension requests within 60 days. EPA will also try to respond to all 8-month
            submissions with a final reregistration determination within 1 4 months after the RED has been
            issued.

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REREGISTRATION ELIGIBILITY DECISION




              CAPTAN



               LIST A



              CASE 120

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                           TABLE OF CONTENTS
CAPTAN REREGISTRATION ELIGIBILITY DECISION TEAM	i

EXECUTIVE SUMMARY	v

I.     INTRODUCTION	 	!

H.    CASE OVERVIEW	              2
      A-    Chemical Overview	     2
      B.    Use Profile	..2
      C.    Estimated Usage of Pesticide	3
      D.    Data Requirements	4
      E.    Regulatory History	5

m.   SCIENCE ASSESSMENT	6
      A.    Physical Chemistry Assessment	6
            1.     Identification of the Active Ingredient	6
            2.     Manufacturing-Use Products	        7
      B.    Human Health Assessment	7
            1.     Toxicology Assessment	7
                  a.     Toxicology Endpoint Selection	8
                        (1)    Reference and Population Adjusted Doses	9
                        (2)    Studies Used to Support the Endpoint Selection	10
                  b.     Acute Toxicity	13
                  c.     Chronic Toxicity/Carcinogenicity	13
                  d.     Metabolism	14
            2.     Dose Response Assessment	14
                  a.     Special Sensitivity of Infants and Children (FQPA Safety
                        Factor)	14
            3.     Dietary Risk and Exposure From Food	16
                  a.     Summary of Residue Data Requirements 	16
                  b.     Summary of Risks from Food		17
                  c.     Dietary Exposure from Drinking Water	18
                  d.    .Occupational Handlers Risk and Exposure	21
                        (1)   Scenarios/Assumptions in Occupational Assessment
                         •••	21
                        (2)   Occupational Handlers Risk Conclusions		25
                        (3)   Occupational Incidents	25
                  e.     Occupational Post-Application Exposure and Risk	26
                       (1)   Assumptions for Occupational Post-Application  .... 26
                       (2)   Occupational Postapplication Risk Conclusions  	27

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             f.      Residential Exposure and Risk	27
                    (1)    Residential Handler Risk		28
                    (2)    Residential Post-application Risk '".	28
             g.      Aggregate Risk  	29
C. ..    Environmental Assessment ,„.._...,	.......	.„..„.....,...,.'.v...,.... .,...,,„....... .,33 i
             EcologicalToxicity Data	'."'.	'..'?'.."."_'...."..'	'.'. '.'"...'.'.'.. 33"
             a.      Toxicity to Terrestrial Animals	33
             b.      Toxicity to Aquatic Animals	35
             c.      Toxicity to Plants ."...".'.......		37
             Environmental Fate '......' ..„ '. ^._.,..,)	.."...,....,_'...'.,.:. v ". .'3$
             a.      Environmental Fate Assessment „.	,,	38
                    Environmental Fate and Transport	39
                    Degradation	'".".	.'.......".	 39
                    Mobility	.41
                    Accumulation ,'...,	.!.'",„„..",..,...",	,,'	 42
                    Field Dissipation	42
                    Spray Drift	.".."		42
                    Water Resources	43
                    (1)    Ground Water	43
             % ^.•.'^•..(2)  '"  SurfaceWater "".._.' .,,.„;',.,;,,.,..,. • •[•:".. r/ :M.	/. -,".45^
             Ecological Exposure and Risk Characterization ................ 47
             a.      Risk Quotient (RQ) and the Level of Concern (LOC) ..... .47
             b.      Exposure and Risk to Nontarget Terrestrial Animals	48
                    (1)    Birds	48
                    (2)    Mammals	52
             ",* ,"  '',.:, (3)    Terrestrial Insects  ..".	"!	"."............... .""55
                    (5)    Freshwater fish	56
                    (6)    Freshwater Invertebrates  	57
                    (7)    Estuarine and Marine Animals	57
             c.      Ecological Risk Due to Seed Treatments  	57
             d.      Endangered Species  	58
             e.      Risk Characterization Summary 	58
                                                                                                   '"It t;
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g.
h.
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                     ; •	;	v
            TV.'   RISI: MANAGEMENT AND REREGISTRATION DECISION ...........;. 61
                   A.     Determination of Eligibility	61
                          1.     Eligibility Decision  	62
            1 ," '."'  ' '".' '.'.„  2:  '_ i" Eligible and Ineligible Uses	i	^		 ..62
            !'"„'',,!:, '':''B. ,"'"  Regulatory Position  ..'.."..."".. '.'.	'."...'.'...	"	'.	"..'. .".'62'"
                          J,...
                          2.

                          3,

                          "4".
                                 Food Quality Protection Act Findings	63
                                 Tolerance Reassessment	66
                                       Human Health Risk Mitigation  	72
             a.
                                 Occupational (both Worker Protection Standard and non-WPS)
                                 Labeling Rationale	81
                                 Other Labeling Requirements	83
                                 a.     Endangered Species Statement	83

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                   b.
Spray Drift Management	83
V.    ACTIONS REQUIRED OF REGISTRANTS	.84
      A.     Manufacturing-Use Products	84
             1.     Additional Generic Data Requirements	84
             2.     Labeling Requirements for Manufacturing-Use Products  	84
      B.     End-Use Products	85
             1.     Additional Product-Specific Data Requirements	 85
             2.     Labeling Requirements for End-Use Products  	85
             3.     Required Labeling Changes Summary Table	 85
      C.     Existing Stocks	         109

VI.   APPENDICES		ln
      A.     Table of Use Patterns Subject to Reregistration	113
      B.     Table of the Generic Data Requirements and Studies Used to Make the
             Reregistration Decision	115
      C.     Citations Considered to be Part of the Data Base Supporting the
             Reregistration Decision	129
      D.     Generic Data Call-In	 163
             1.     Generic Data Call-In Chemical Status Sheet	181
             2.     Generic DCI Response Forms Inserts (Insert A) plus Instructions  182
             3.     Requirements Status and Registrants' Response Forms (Insert B) plus
                   Instructions	185
      E.     Product Specific Data Call-In	191
             1.     Product Specific Chemical Status Sheets	204
            2.     Data Call-in Response Form for the Product Specific Data(Form A
                   inserts) Plus Instructions 	205
            3.     Product Specific Requirement Status and Registrant's Response
                   Forms (Form B inserts) and Instructions 	207
            4.     EPA Batching of End-Use Products for Meeting Data Requirements
                   for Reregistration	215
            5.     List of All Registrants Sent This Data Call-In (insert) Notice 	226
      F.    List of Available Related Documents and Electronically Available Forms. 227

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            CAPTAN REREGISTRATION ELIGIBILITY DECISION TEAM

 Office of Pesticide Programs:

 Biological and Economic Analysis
 John Faulkner
 Steve Jarboe
 RichMichell

 Environmental Fate and Effects Assessment

 Iwona Mayer
 Kevin Costello
 Harry Craven
 Richard Mahler
 Norman Birchfield

 Health Effects Risk Assessment

 David Hrdy
 Thurston Morton
 Sanju Diwan
 Paula Deschamp
 Shiela Piper

 Registration Support

 Cynthia Giles-Parker

Risk Management

Kylie Rothwell
Kathryn Boyle
Susan Jennings
 Economic Analysis Branch
 Biological Analysis Branch
 Biological Analysis Branch
Environmental Risk Branch I
Environmental Risk Branch I
Environmental Risk Branch III
EnvironmentalRisk Branch I
Environmental Risk Branch I
Reregistration Branch IV
Reregistration Branch IV
Reregistration Branch IV
Reregistration Branch II
Chemistry and Exposure Branch I
Fungicide Herbicide Branch
Reregistration Branch III
Reregistration Branch III
Reregistration Branch III

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                GLOSSARY OF TERMS AND ABBREVIATIONS
 ADI
 a.i.
 ARC
 CAS
 CNS
 CSF
 DEEM
 DFR
 ORES
 DWLOC
 EEC

 EP
 EPA
 FAO/WHO
 FDA
 FIFRA
 FFDCA
 FQPA
 FOB
 GLC
 GM
 GRAS
 LC50
LD,
LEL
LOG
LOD
LOAEL
LOEL
MATC
MCLG
mg/L
MOE
MP
MRID
N/A
NOEC
NPDES
NOEL
 Acceptable Daily Intake. A now defunct term for reference dose (RfD).
 Active Ingredient
 Anticipated Residue Contribution
 Chemical Abstracts Service
 Central Nervous System
 Confidential Statement of Formula
 Dietary Exposure Evaluation Model
 Dislodgeable Foliar Residue
 Dietary Risk Evaluation System
 Drinking Water Level of Comparison
 Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
 such as a terrestrial ecosystem.
 End-Use Product
 U.S. Environmental Protection Agency
 Food and Agriculture Organization/World Health Organization
 Food and Drug Administration
 Federal Insecticide, Fungicide, and Rodenticide Act
 Federal Food, Drug, and Cosmetic Act
 Food Quality Protection Act
 Functional Observational Battery
 Gas Liquid Chromatography
 Geometric Mean
 Generally Recognized as Safe as Designated by FDA
 Median Lethal Concentration.  A statistically  derived concentration of a substance that can be
 expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
 per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
 of the test animals when administered by the route  indicated (oral, dermal, inhalation).  It is
 expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
 Lowest Effect Level
 Level of Concern
 Limit of Detection
 Lowest Observed Adverse Effect Level
 Lowest Observed Effect Level
 Maximum Acceptable Toxicant Concentration
 Maximum Contaminant Level Goal (MCLG)  The MCLG  is used by the Agency to regulate
 contaminants hi drinking water under the Safe Drinking Water Act.
 Micrograms Per Gram
 Micrograms per liter
 Milligrams Per Liter
 Margin of Exposure
 Manufacturing-Use Product
 Master Record Identification (number). EPA's system of recording and tracking studies submitted.
Not Applicable
No Observable Effect Concentration
National Pollutant Discharge Elimination System
No Observed Effect Level
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             PHI
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             FPE
             ppm
             PRN
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             WPS
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          GLOSSARY OF TERMS AND ABBREVIATIONS

   No Observed Adverse Effect Level
   Office of Pesticide Programs
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 EXECUTIVE SUMMARY

        The US Environmental Protection Agency has completed its reregistration eligibility
 decision for the pesticide captan (N-trichloromethylthio-4-cyclohexene-l,2-dicarboxunide).The
 Agency has considered generic data to support the reregistration of captan and determined that
 these data are sufficient to support reregistration of products containing captan, except for those
 with uses on turf and aerially-applied wettable powder formulations. Products applied to turf at
 sod farms or golf courses are eligible for reregistration; uses at all other turf sites are being
 voluntarily canceled. Wettable powder formulations that are applied aerially are eligible for
 reregistration, provided either:  1) the products are packaged in water soluble packaging; or 2) the
 application rates are reduced to a level that is no higher than 1.2 Ib ai/A.

        This reregistration decision also considered the requirements of the "Food Quality
 Protection Act of 1996" (FQPA) which amended the Federal Food Drug and Cosmetic Act and
 the Federal Insecticide Fungicide and Rodenticide Act, the two Federal statutes that provide the
 framework for pesticide regulation hi the United States. FQPA became effective immediately
 upon enactment on August 3, 1996 and the new REDs are being evaluated under the new
 standards imposed by FPQA. The Act directs EPA to consider the potential for increased
 susceptibility of infants and children, to evaluate the toxic effects of pesticide residues, and to
 develop a screening program to determine whether pesticides produce endocrine disrupting
 effects.

        Captan is a non-systemic fungicide used to control diseases hi orchard crops, berries,
 seeds, turf, and ornamentals. Captan is also incorporated into paint and adhesives as an in-can
 preservative. The pesticide has several formulations and is applied by various methods, including
 aerial, airblast, and groundboom. Captan is also  applied as a postharvest dip to apples, cherries
 and pears. Captan's technical registrants are Tomen Agro, Incorporated, and Makhteshim-Agan
 of North America, who are both members of the  Captan Stewardship Task Force.

 Reregistration Eligibility

       The Agency has concluded, under the Federal Insecticide, Fungicide, and Rodenticide Act
 (FIFRA), that captan products, when labeled and used as specified in this document, will not
 cause unreasonable adverse effects on human health or the environment and are, therefore, eligible
 for reregistration.  The Agency has conducted both human health and ecological risk assessments
 for captan, and has also evaluated data on its major degradates, THPI and THPAm. The Agency
has determined that THPAm has no toxicological significance. However, THPI does have
toxicological significance and was included in the dietary risk assessment.  For captan, the
carcinogenic process is thought to be triggered by the highly reactive but short-lived metabolite
thiophosgene.  The Agency has classified parent captan as a B2 (probable human) carcinogen.  •
Since THPI is not believed to contribute to the carcinogenicity of captan, it is not factored into
the cancer risk assessment.

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             Human Health Bfiects
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      ','fine human health risk assessment evaluated toxicological and exposure data to develop
	 '; .  »?E	Sit.iiiiiii:  ''alii	i!1;:;	v..",» .   ,'>:< ;>;;," ;•  ,(  '	 -	r	 *;• a '•<,•• i"  •.	  w ,.	 ,• . ,-f	.	 •.	 . •  ,.  r  ,.
d|etary, drinking water, residential, aggregate and occupational exposure analyses, and to assess
|Łe''adequacy of existing tolerances. Because the available studies demonstrated no indication of
increased sensitivity of animals to in utero or postnatal exposure to captan and the database is
complete, the Agency determined that there is no evidence of special sensitivity to infants and
children, Therefore, the FQPA Safety Factor was removed (reduced to IX) for captan and the
RfD equals the PAD.

       The developmental endpoint in rabbits, with a NOAEL of 10 mg/kg/day, was selected for
the acute Reference Dose and the short- and intermediate-term dermal risk assessments. A three-
geheration reproduction study hi rats is the basis for the chronic RfD.  The NOAEL in the study
Iras; 12,5 rng/kg/day.  Captan is severely irritating to the eyes and is classified in the Toxicity
Category I.	      '		

       TheA^
j&Jpfeari and fplpet^ whichi implicates their common metabolite, to           Because
Jtuophosgene is so highly reactive in animal systems, its residues cannot be scientifically
quantified. Without measurable residues of the common metabolite, it is difficult to relate
|xpostires of captan to those of fblpet since the rate of thiophosgene formation may be different
for both compounds.  The Agency  has conducted a conservative aggregate assessment for
thipphpsgene, assuming that it may cause cancer through both captan and folpet, and has
4eterminei'  >  .'>:•  "i"
          I	iii"?!1  '  <;	.:•'.-+	IS!  Slit '";> lj'"   ,:  '"*;•   '  •>.i^-:f,t •',.''•'"••'.•: .;<*'';; :'>llii"  .(..,';• ,;'...f; .!'!; "": "Hi;	.«;   M^^T^i
                 The Agency has determined that acute and chronic dietary (food and water) and cancer
          aggregate risks are not of concern.  Residential exposure from the use of captan around the home
.Tit: :.iH:  ;"""
                                                         VI

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 does not exceed the Agency's level of concern when aggregated with food and drinking water
 exposure.

        For occupational scenarios, most risk estimates were well above 100 (values below 100
 are a concern for captan) with cancer risks ranging from 1.3 x 10'5 to 1.7 x 10'9. There is a
 concern for mixers and loaders of wettable powder for the aerial application of captan. The
 Agency believes that this risk will be adequately mitigated by requiring water soluble bags or a
 suitable reduction in application rate. Reentry Intervals were also reevaluated during the RED
 process and new REIs are being established ranging from 12- hours for seed treatment uses to 4-
 days for ornamentals.

        The Agency has reassessed captan food and feed tolerances under the standards of FQPA.
 Because THPI was detected in plant metabolism studies at less than 10% of total residues, the
 tolerance expression for plant commodities should remain as captanper se. Because captan is
 extensively metabolized to THPI in animal tissues, the tolerance expression for captan residues in
 animal commodities should include THPI as well as captan. Crop group tolerances are being
 established for various groups of related vegetables. Many of these tolerances support seed
 treatment only, as the foliar applications have not been permitted since the  PD4 was issued in
 1989.  The crop subgroup tolerance for caneberries (raspberries and blackberries) is being
 established to support Special Local Needs registrations in Oregon, Ohio, Pennsylvania, South
 Carolina, and Washington.

 Ecological Risks

       For ecological risk, only acute toxicity to freshwater fish is of concern. The Agency is
 requiring label modifications, including updated spray drift language, that are expected to mitigate
 this risk. There are no reported fish kills. Additionally, the Agency has determined that captan is:
 practically nontoxic to avian species, both on an acute and subacute basis; not acutely toxic to
 mammals, and relatively nontoxic to insects. Terrestrial and aquatic plant toxicity is not a
 concern. Both THPI and THPAm were found to be non-toxic to fish species tested. The Agency
 is requiring a 96 - hour oyster shell  deposition study, however, these data are considered
 confirmatory and are not expected to change the conclusions of this risk assessment.

       For environmental fate concerns, captan dissipates rapidly, with a half-life of less than 1
 day, determined by hydrolysis and soil aerobic studies. THPI and THPAm are not expected to
persist in ground and surface water.

Risk Mitigation

       To reduce the risks posed by captan, the Agency is requiring the following mitigation
measures for captan-containing products:

             Voluntary cancellation of the residential turf use;
                                           vn

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St.. '",«{, ;:  ' i •    i*!1'   •  ;:.i..   •',!•   ijK , ;'    ,	„  "i  '.,•• •; -v !         1!        *   • f   ,  ' •  V •,.*  '!i   |i'  	' '   !'!  .'.     '  !'  V| k .i 'jil!-
    :"  , "''"I]!   ' : fa I!!: , ' "   ' '   i',1   J1 ,, i",   ''  ' '  "l"1  :	i,i, «'     'i,;i        ,„ ,       ,  ' ,lih '1,1  " '   '  , ililr, ,,  '    '" 	j|  :              '„"','  ,  ,!lr': »: rwiliiji,
  ''. •.::.;,	',,;    ' 'jl|,'': ,:„,„ ,1	, .p,  • J.   .SJater-sphible packagmg^for the wettable powder formulation used aerially
                      •?       Various Personal Protective Equipment, including chemical-resistant gloves,
                              aprons/coveralls, eye protection, and dust/mist respirators;
                      ,-r       Revised labeling to reduce the risks to non-target aquatic organisms;
                      •^       Eye wash stations for occupational field workers; and
                              b'oubie notification for workers entering treated fields.
  -"•'V;;:' ,	:~   '  :f "    ;'"';'  --;:;.  _;"=;  '''  ' :::;	;.; '"''"-  ;. _  ' ;':.  "^ :  , '	'  ;  :-  ..I' ' .;;;;: ^ „'  ;  ;:'..].:  / ••' ;'  ;..:•}•:. " ^'.
                      Before  reregistering me products containing captan, the Agency is requiring that product
              specific data, revised Confidential Statements of Formula (CSF) and revised labeling be submitted
              Within eight months of the issuance of this document. These data include product chemistry for
              each registration and  acute toxicity testing. After reviewing these data and any revised labels and
gf 1;", ,||; ;!!:l  ;||admg them^acceptabie in accordance with Section 3(c)(5) of FIFRA, the Agency will reregister a
              product TEose products which contain other active ingredients will be eligible for reregistration
              only when the other active ingredients are determinedito be eligible for reregistration.
                                                                                                                  '.•'ll	i.  I
                                                                                                                  •t	:•;•;•	1
nil< 1111'! ' ' I"1!!1 "' • in ,,ii     lit:!11   ' „
„ ; iH'li > "'il 
-------
 I.
INTRODUCTION
       In 1988, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) was amended to
 accelerate the reregistration of products with active ingredients registered prior to November 1,
 1984. There are five phases to the reregistration process. The first four phases of the process
 focus on identification of data requirements to support the reregistration of an active ingredient
 and the generation and the submission of data to fulfill the requirements.  The fifth phase is a
 review by the U.S. Environmental Protection Agency (referred to as "The Agency") of all data
 submitted to support reregistration.

       FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
 whether pesticides containing such active ingredients are eligible for reregistration" before calling
 in data on products and either reregistering products or taking "other appropriate regulatory
 action." Thus, reregistration involves a thorough review of the scientific data base underlying a
 pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
 arising from the currently registered uses of the pesticide; to determine the need for additional
 data on health and environmental effects; and to determine whether the pesticide meets the "no
 unreasonable adverse effects" criterion of FIFRA.

       On August 3,1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-
 170) was signed into law.  FQPA amends both the Federal Food, Drug, and Cosmetic Act
 (FFDCA), 21 U.S.C. 301 etseq., and the Federal Insecticide, Fungicide, and Rodenticide Act
 (FIFRA), 7 U.S.C. 136 et seq. The FQPA amendments went into effect immediately and EPA
 initiated an intensive process, including consultation with registrants, States, and other interested
 stakeholders, to make decisions on the new policies and procedures that will be appropriate as a
 result of enactment of FQPA.  This process will include a more in depth analysis of the new safety
 standard and how it should be applied to both food and non-food use pesticides. The FQPA does
 not, however, amend any of the existing reregistration deadlines set forth in §4 of FIFRA.
 Therefore, in light of the unaffected statutory deadlines with respect to reregistration, the Agency
 will continue its ongoing reregistration program while it continues to determine how best to
 implement FQPA.

       This document presents the Agency's decision regarding the reregistration eligibility of the
 registered uses of captan including the risk to infants and children for any potential dietary,
 drinking water, dermal or oral exposures, and cumulative effects as stipulated under the FQPA.
 The document consists of six sections.  Section I is the introduction. Section II describes captan,
 its uses, data requirements and regulatory history.  Section III discusses the human health and
 environmental assessment based on the data available to the Agency.  Section IV presents the
reregistration decision for captan. Section V discusses the reregistration requirements for captan.
Finally, Section VI contains the Appendices that support this Reregistration Eligibility Decision.
Additional details concerning the Agency's review of applicable data are available upon request.

-------
                           • ir."t ....  '    !   •
                            !;i:i}/'  '••*• J:,  ,  t"-,.
                   "Ml,''"I	: ..siir   "i,,'.;'  '' •••/*.    '  An
                   ., .'    '-iii1,;,  'iii ,  '  :"„
                     CASE OVERVIEW
                     A.     Chemical Overview

                     The following active ingredient is covered by this Reregistration Eligibility Decision:

                 ,  «	•	„,„,CommonNamej   .      ,   Captan
                        I' "Iiii1  Tijijii , i j: "',„	.i;i,   	I'l "i' ,,|i" i
                                  ical Namie: 	   „  N-McUorpmethyKhio-4-cyciohexene-l,2-
                                     '   ''''"
                                                                                                        -.:	i
                  (:
       Chemical Family:          Dicarboximides

       CAS Registry Number:     133-06-2

    .'.  ^JPP' Chemical Code:   ' 	"  081301   '"  "  ""'_  """"''''"""""''  ' ""  	'	'  ''''

       Empirical Formula:        C^gCySK^S

       Trade and Other Names:   Merpan, Orthocide, Vondcaptan, Vancide-89, SR-
(.if I	"	[;.  , f
Si!	ill ••» ,
             t, ;
             I	Li i
                            Basic Manufacturer:
                                   Gustafson, LLC; Makhteshim-Agan of North
                                   America; Drexel Chemical Co.; and Tomen Agro,
                                   Inc.
                     B.     Use Profile
                                                                ..if".....11   . !!",;i,iiir.' .in. .mi.:
       The following is information on the currently registered uses with an overview of
use'sites and application methods.
       	  	     ,,,	 ....   .	'" '  il
       Type of Pesticide:   Fungicide or antimicrobial pesticide
                            Use Sites:
                            Variety of terrestrial food/feed crops, greenhouse food
                            crops, indoor food (fruit dips), indoor non-food (e.g.,
                            paints, adhesives, etc.), seed treatments and ornamental sites
                      	.; "...fit,
                     "0	, ii	I'",
       Target Pests:        Numerous fungi and microbials
        I'l                     I   II  ,,i,;  "jij ' . "; i,'1:!" '< :,,;.:  ' •'	i" ' : .'"' "	!l»'I'111   '""',;''  M'i -,1"1-  .,',.. ..hill,"1	'H, ' ill*

       Formulation Types: Dust (5 to 75%), emulsifiable concentrate (6 to 29%),
                            flowable concentrate (10 to 75%), ready-to-use liquid (14
                            to 30%), liquid soluble concentrate (12%), solid (62 to

             ',  •'   '  	,    "' ,'     ''•• „   '     " '":i,i;   ,"' ! ":'i" • I'i	'" .  , ."'• ' I  ' ,.','•"   '""'I, '' '  .   .' I  i
             il-
                                                    ,,,,!:'', iii
                                                    ." .iii'- •"
                                                                                                     .,;,(! .-i IS
  EiiiEiaj	i.	•iiii  	>-.i;:,:!i
                         IE Ii; IlllllE , ...... III! ...... „!'!!" 'Si! ...... Ilitti ..... ill ..... llliii.l; ..... , 1* i ......... ... i ..... H ..... IBI ........ i,i;:,:, ....... •• ..... !.l ........... ' ...... iti...!:..!!.'!.), ...... i t"li.', i1:1.!. .J i ..... i!"
                                                                              'Jialb,: nil: in] ..... ..... !!' ........ !:> .......... J. ', . : iiii ..... iiin. : i)ii.: .......... i,,- In ...... 1 1 ......... !!! .'111

-------
                                   90%), water dispersible granules (75%), wettable powder
                                   (6 to 80%), wettable powder/dust (5 to 50%)

              Application Techniques: Applied at all phases of crop growth including: seed,
              foliage, blossom, soil, fruit, dormant, dip, and post-harvest commodity treatment.
              Also used in industrial applications as a bacteriostat.

                     Methods:      Broadcast treatment, chemigation, dust, dip, and seed
                                   treatment to soil and spot treatments

                     Equipment:    Aerial equipment; airblast; chemigation equipment; dip tank;
                                   drill box; duster; hand held duster; liquid seed treater;
                                   paintbrush; paper bag; planter/seed box; power duster; seed
                                   treater; slurry-type seed treater; spray-dip machine;
                                   sprayers; squeeze applicator; tank; and tank-type sprayer

       C.     Estimated Usage of Pesticide

       The table below summarizes the best available estimates for the pesticide uses of captan.
These estimates are derived from a variety of published and proprietary sources available to the
Agency.  The data, reported on an aggregate and site (crop) basis, reflect annual fluctuations in
use patterns as well as the variability hi using data from various information sources.
Domestic Foliar Usage of Captan
Site
"" Ł * i
Aimonds
Apples
Apricots
Blackberries
Blueberries
(huckleberries)
Cherries, Sweet
Cherries, Tart
Dewberries
Grapes
Nectarines
Peaches
Plums
Acres'
Grown.
(000)
429
572
19
N/A
59
64
64
N/A
825
29
212
64
Acres
Treated,(000)
Wtd
Avg
80
270
4
N/A
36
8
18
N/A
40
3
86
8
• Est
Max
112
376
8
N/A
41
12
28
N/A
100
8
118
16
%,ofCrop
Treated^
Wtd
Avg*
19%
47%
18%
N/A
61%
12%
28%
N/A
5%
10%
41%
13%
~E
-------
ill	ll  	
Site
Prunes
Raspberries
Strawberries
Total
Post Harvest
Apples
Cherries
Pears
Acres
Grown
(000)
80
11
50

Acres
Treated (000)
Wtd
Avg
25
7
31
616

-
N/A
-
-
N/A
-
Est
Max
44
8
45
915

-
N/A
-
% of Crop
Treated
Wtd
Avg
31%
62%
63%


11%
N/A
20%
Est
Max
55%
68%
89%

LBAI Applied
(000)
Wtd
Avg
93
36
540
4006
Est
Max
164
53
1,086
7000
Avg Rate of
Application
#app
/yr
1.2
3.1
8.2

Ibai/
A/app
3.2
1.6
2.1

States of Most Usage
(state and % ai used)
CA 100%
WAOR93%
FLCAPA83%


22%
N/A
40%
3
N/A
0.2
-
N/A
-
-
N/A
-
-
N/A
-



                SOURCES; EPA data (1987-97), USDA (1990-97), and National Center for Food and Agricultural Policy (1992 data)Tables exclude all uses that
                have been cancelled as a result of the 1989 Special Review Decision.

               :COUJMN HEADINGS:	         	[
                       Weighted average is based on the most recent years, with more reliable data weighted more heavily
                       Estimated Maximum is estimated from available data.
                       Average application rates are calculated from the weighted averages.

                NOTES ON TABLE DATA - Calculated numbers may not agree due to rounding to nearest 1000 for acres treated (0 acres =< 500) and to nearest
                whole percentage for % of crop treated (0% = < 0.5%). Dash (-) indicates NOT available or insufficient data in EPA sources.
                                                                                   , „ |          j;

                                           Seed Treatment - Usage of Captan in  1990
Seed Treated
Corn
Sweet com
Beans
Pets
Potatoes
Soybeans
Sorghum
Peanuts
Cotton
Wee
Totnl Seed
% Seeds
Treated
100%
80%
80%
90%
11%
5%
100%
60%
50%
0%

Seed Treated
(million Ibs)
1,020
18
144
99
290
141
77
106
147

2.042
App Rate
Ibai/1 000 Ib seed
0.7
1.0
1.0
1.0
0.8
0.7
1.6
1.6
1.4


Applied
lbai(000)
714
18
144
99
246
98
123
170
206
.
1.818
Seeding Rate
Lb seed/Acre
14
16
60
220
2,000
60
7
102
24
.

Ibaf/Acre:
on Seeds
0.01
0.02
, 0.06
0.22
1.70
0.04
0.01
0.16
0.03
0.00

Acres Planted
(000)
72,85"
1,10(
2,384
451
145
2,342
10,694
1,04(
6,133
_
97,14'y
               SOURCES: EPAdata(1991)
                                          l ir   Si, 	Ill	,.
                       D.     Data Requirements
                       "I j,||' ,11,1111; ..... i| ,.„;.; ...... ..... , ji,, i , ,||| , ........ ~ i '" . JL
                              '        '     1 "
                     ,, ,,,  ,  ,       ,       ,  ,,    ,,,,              ,       ,    ,             ,, ,,,,,,  ,   „  .   .  ,       ,,  .  ,    ,
                       The Agency required the registrants to submit studies as specified hi 40 CFR Section 158.
               • Data. :&Qm.^se.|tU:dies.axe suJSIcient to characterize the risks associated with the uses described
               in this document.  Appendix B includes all data requirements identified by the Agency for
               currently registered uses needed to support reregistration.

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        E.     Regulatory History

        Captan was first registered as a pesticide under the Federal Insecticide, Fungicide and
 Rodenticide Act in 1951 for the control of fungal diseases of fruit crops. Prior to 1980, there
 were many use-patterns registered and tolerances established for this broad spectrum fungicide.
 Currently, there are 159 registered products (including 17 State and Local Needs) containing
 captan.

        In 1980, EPA published a Notice of Rebuttable Presumption because it had concluded that
 there were adequate data to determine that captan could induce oncogenic effects in experimental
 mammals (mice and rats). In addition, mutagenicity studies demonstrated that captan could cause
 gene mutations in bacteria, in eukaryotic microorganisms and in mammalian cells in culture. The
 public notice requested that registrants and other interested persons submit rebuttals and other
 information on the presumption and to submit any other data on the risks and benefits of captan.

        A DCI issued April 29,1985 required the submission of residue chemistry and toxicology
 studies. Subsequently, a proposed-decision was published (50 FR 25884), which was quickly
 followed by a supporting document entitled, "Captan Special Review Position Document 2/3."
 Based on cancer risks, it was proposed that all food-uses of captan be canceled and that all seed
 treatments be retained.  The proposal allowed time for additional residue chemistry data to be
 submitted to refine the amount of residues used hi the dietary assessments.  The proposal also:
 allowed the continued feeding of detreated corn seed to cattle and hogs, if fed at least fourteen
 days prior to slaughter; required workers to wear dust masks and impermeable gloves when
 applying, mixing or loading captan formulations; and required harvesters and weedpickers to wear
 water-resistant gloves when working in fields or nurseries in which ornamentals have been treated
 with captan formulations. For non-agricultural uses of captan, the Agency proposed that:
 persons incorporating captan into products such as adhesives, plastics and paints wear
 impermeable gloves, respirators and protective clothing; and labels be amended to require
 impermeable gloves when applying oil-based paints for home or professional use.

       In March, 1986, the Agency issued a Registration Standard for captan.  The Registration
 Standard summarized the data that had been submitted in support of the captan registration and
 identified data gaps that needed to be addressed in order to reregister all captan pesticide
 products.  A 1988 Data Call-In Notice required the submission of a 90-day rat inhalation study
 and a 90-day dermal study in rats.

       In 1989, the Agency published the Position Document (PD4) to conclude the Special
 Review of captan (54 FR 8116). This notice announced the conclusion of the Agency's Special
 Review and risk/benefit analysis of captan registrations. EPA evaluated the issues raised hi the
 PD 2/3 and additional data received during the Special Review process.  With this notice, the
Agency determined that the following uses of captan could remain: all non-food uses, seed
treatments, and a subset of the existing food uses (almonds, apples, apricots, blackberries,
blueberries, plant-bed for celery, cherries, dewberries, plant-bed for eggplant, grapes, lettuce,

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'•Ill  t	mil, I'  'li  i,, ' ., Iii^ „;,;',„ V 	 ,:« '^fili:  wffl| v *  , ,1'!;,"' Y»	, "  V
                                                                                                     !k.,r ^feW'! !(	I,1'!' :,. til
                                                                                       iilill,/ ' • ,,|iv 11 •,, 	»'",   , 'I  TIM", i! ,  1,1 nil
HIT ,'  1 ,iH', < II i ,,i,
li^	.1 J!"i' <"'  V*	:' ,,,!r:i'!""
   I"!	' i "  I1, T  i   '
   »t(. is  "
Lif !;H "i,
LJIIII i;	 V,
 at  >t	1,,  i v! iii	,'L
 mangoes, nectarines, green onions, peaches, post-harvest on pears, plant-bed for peppers, plant-
 bec| f» .\"' •'.''	:5	'"f ;  "   <'•   '''	  . * -ti;   • i5'::''.''  .,   .' J;',":''',!,  . i'?;::'  . •• T,,: ;  ', /..;' ;;/;
               1.    Identification of the Active Ingredient

        Captan [^-tricMorpmethyltWo-4-cyclohexene-l,2-dicarboximide)(trade names: Merpan,
 Orthocide, ^onScaptan, Vancide-89 and SR-46)] belongs to the chemical class of dicarboximides
 or chlorinated ojganosulfur compounds.
             !
              iiiiiii
                                                                     i,	i ,
                                                                     • i,	, ,<
             T '    IE,

-------
                           \
                            CCI3
       Captan
       Empirical Fonnula:
       Molecular Weight:
       CAS Registry No.:
       PC Code:
       lUPACName:
                           THPI (Captan metabolite)
C9H8C13NO2S               Molecular Weight:    151.16
300.61                     Empirical Formula:    C8N9O,
133-06-2
081301
l,2,3,6-tetrahydro-N-(trichloromethylthio)phthalimide
       Pure captan is a colorless crystalline solid with a melting point of 178 °C; a vapor pressure
 of<1.3 mPaat25°C; and an octanol/water partition coefficient of 61 Oat 25 °C.
 Solubility of captan in water is 3.3 mg/1 at 25 °C and it is soluble hi acetone, ethyl alcohol,
 kerosene, xylene, chloroform, and benzene.

              2.     Manufacturing-Use Products

       There are nine manufacturing-use products registered at this tune: an 88% formulation
 intermediate and an 88% technical (19713-258,19713-500) registered to Drexel Chemical
 Company; an 88% technical registered to Gustafson, Inc. (7501-24); an 88% technical registered
 to Makhteshim-Agan of North America Inc. (11678-1); three 88% technicals and an 87%
 formulation intermediate registered to Tomen Agro, Inc. (66330-31, 66330-32, 66330-33 and
 66330-34, respectively), and an 88% formulation intermediate registered to Sostram (72304-3).
 Both Tomen Agro, Inc. and Makhteshim-Agan are members of the Captan Stewardship Task
 Force.

       B.     Human Health Assessment

              1.     Toxicology Assessment

       The toxicology database is adequate to assess health hazards resulting from exposure to
captan. In acute toxicity studies, captan is not toxic via the oral route, and has low toxiciry via
the dermal and inhalation routes. Captan is severely irritating to the eyes. Repeated dose toxicity
studies (e.g. 21-day dermal, 90-day subchronic inhalation and chronic oral) indicate that
thiophosgene causes local irritation of the skin, larynx or lining of the gastrointestinal (GI) tract
depending upon the site where it is generated.

-------
               I'1'"]!""!! "'Ilil	II!	C,f
                                          	si!1"'. 'I:	">u:	IIHE:	t	:;	litres
                                                                          "i"v"!"l; • ,'lii';:	 4"'I,1' 'LMii -I'' 	»!J
                                                                                            J	'"i'!' "L ;, •;. Hill
viiilK::1 ll|! ,' jiiili «: fill
                     At doses that are maternaliy toxic, captan causes developmental effects in experimental
             |!" '"'lA'.'!.'!	IIIIIIK^     '	Ill	I illlr 'dwr"-J'	i'	**t -.1 i  '	 Ł•	• .• •	•	.'. ~-	••.	,,	 •:•  •	...jJu		•	 ..- «
              Animals producing delayed ossification and post-implantation loss in hamsters, and increases in
              skeletal defects in rabbits. At doses that are toxic to the parent, captan causes decreased pup
              litter weights in a reproduction study.

             	' •  "'  '   '"	":|:   '  a.,"  ; Toxicology Endpoint Selection
                                                                                 'i
                     The Agency has established toxicological endpoints for acute and chronic dietary, as well
              as occupational and residential (dermal and inhalation) exposure risk assessments for captan. The
              selection of these toxicological endpoints is based on a comprehensive evaluation of the available
              toxicology data as well as the use pattern/exposure profile for captan.

                     For deriving the acute Reference Dose (RfD), the Agency selected the developmental
              NOAEL of 10 mg/kg/day from the prenatal developmental toxicity study in rabbits. This
              endpoint was selected because it is  thought that the observed developmental effects could occur
              following a single exposure, however, since these effects can occur only in utero, they are
              applicable only to the acute risk assessment for females (ages 13-50). Following a review of the
              available toxicology database, the Agency did not identify any other ex utero toxicological
              endpoint that could be attributed to a single exposure of captan. This review included
              consideration of the maternal effects noted in the developmental toxicity studies; however, the
              maternal effects noted in these studies (mortality, decreased body weight and food consumption)
              were not attributed to a single dose of captan. Therefore, no separate acute endpoint was
              selected for the general population, which includes infants and children. Thus, a risk assessment
              was conducted only for the females (13 - 50).
              111      I   Illllll III   IIIIIIIII I         III   ,  '  SHIS J ,   " '•  h.ii*..  ti.  ':	'i' It ••"'"  't'ii1;   : ii	"'Hi:,	'.• .i , "  ,11	IV'1 	 "' 1'; - "J I11:1:1 lit"
                     The developmental endpoint in rabbits, with a NOAEL of 10 mg/kg/day, was also selected
              for the short- and intermediate-term dermal risk assessments. The 21-day dermal toxicity study in
              rabbits was not selected for these risk assessments, even though if is the most appropriate route of
              exposure.  In this study, repeated dermal application of captan caused dermal irritation, but only
                                                                                                           il	;",
                                                          8

-------
 minimal systemic effects (reductions in body weight, body weight gain, and food consumption) at
 a dermal dose of 1000 mg/kg/day, with a systemic NOAEL of 110 mg/kg/day. However, effects
 on fetuses are not investigated in a guideline 21 -day dermal toxicity study. Thus, because of the
 potential for occupational or residential dermal exposure to pregnant women, the more
 conservative NOAEL from the oral developmental toxicity study in rabbits was considered
 appropriate for the short- and intermediate-term dermal risk assessments.
Summary of Doses and Endpoints Selected for Captan Risk Assessments
Exposure ! -v<,
Scenario
Acute Dietary
Female 13+
Chronic Dietary
, Dose
(nig/kg/day)
NOAEL=10
UF = 100
FQPA=1
' , Endpoint „ J
30 mg/kg/day based on increased
skeletal defects (27 pre-sacral
vertebrae) in fetuses. Applies to
females 13+ only; no appropriate
endpoint for general population.
Study
Developmental
Toxicity Study in
Rabbits
Acute RfD=aPAD = 0.1 mg/kg/day
NOAEL=12.5
UF=100
FQPA=1
25 mg/kg/day based on decreased pup
body weight
One- and three-
generation repro
Studies-Rat
Chronic RfD = cPAD = 0.13 mg/kg/day
Correction for oral to dermal exposure necessary (0.4% per hour; dermal absorption factor)
Short- and
Intermediate-Term
(Dermal)
Long-Term (Dermal)
Oral
NOAEL=10
UF=100
None
30 mg/kg/day based on increased
skeletal defects (27 pre-sacral
vertebrae)
Use pattern and exposure indicate no
need for long-term risk assessment
Developmental
Toxicity Study in
Rabbits

Use 100% lung absorption relative to oral absorption
All Durations
(Inhalation)
Q.'
Oral
NOAEL=10
UF=100
2.4 x lO'3
30 mg/kg/day based on increased
skeletal defects (27 pre-sacral
vertebrae)
Based on findings of intestinal tumors
in mice
Developmental
Toxicity Study in
Rabbits
Mouse
Oncogenicity
                           (1)    Reference and Population Adjusted Doses

       As indicated earlier, the Agency is establishing an acute Reference Dose (RfD) of 0.1
mg/kg/day, based on a NOAEL of 10 mg/kg/day from a developmental study hi rabbits. In this
study, post-implantation loss, reduced mean fetal weight, and increased skeletal defects in fetuses
were observed at 30 mg/kg/day. This dose reflects application to the NOAEL of an uncertainty
factor of lOOx to account for interspecies extrapolation and intraspecies variability. The acute

-------
Tl	" j, ,,i:"i,i;" ;'	K'
"»: J jlii^'n
 V 111	iE" I . l'l
  11 "H' ill'111 „ I < IP'1'!1


  lliPF !'!'!!,!, ''''p',"!'!1 IP ,„/'

IB'W J I "I'1  ij
HBI ! ""(i,  ...... -I1
  If I, III
                                                                       II
 RfJC) is, appropriate for assessing acute dietary risk for females 13-50 years only. No acute RfD is
 needed to assess dietary risks for other population subgroups, as no other acute dosing toxicity
 Study showed any other effects
	IIIT: "Hi ;", tin'ii	- ,'	 'nil',:-i", itiii •  if	'.	 ft	;\; •    i  '•.   , !. ;, '      ' ''i : :: : : ,i  • it	-iiii ' , :  ••• vjii	•:*.   , y	 	i -ii" cr..1
                            11   II	."»	'	 IP   '	 ...    ' i	, i	,,,1".. ,„, ' nil1 "I11!1.  I1!"".' "Hi '  , '"III: . '""I. ""  .. ' j, ' .1; "i I. "  Ir '      liil	
                       MI reproduction study in rats is the basis for the chronic RfD. The
               I	•	•	;:
             UOAEL ,in &e ftudy was 12.5 mg/kg/day, based on decreased mean litter weights at the next              |
             higher''dose level of 25 mg/kg/day. The chronic RfD of 6.13 m'g/k^/day is obtained by application
             of an uncertainty factor of 100 for interspecies and intraspecies variability.
                 ,,."| :,'!:i	 •  ..mn SIT1 	il"!!	I	' "!•,
        Although the NOAEL chosen for the chronic RfD is slightly greater than the NOAEL
 Chosen for the acute RfD; the endpoints are similar when considering the spacing of the dosages
 of the two studies and the fact that the two studies used different species. For practical purposes,
 nil;, I  ,,,|'>I> f' .111	,,t,'  Ili'TiFJ'''.'.!!./^!"!!!!!!!!!  ' 	fi'il "iMIimii.1 uliii	I, t ,11	"|i,ii!!'i "" ,,	11,'iliii'"! '"• '!' ",  • .'I1 ' ' 	 •'• '••', ', ,„ !,,|',|,''» ,||||l , pgf ,,«["' i  ,i " i	i	, 1,1 "i	,	 1,11 	', An	   	   rT ,,,-T  	 ,	
 the numb^s Ł10 versus 12.5 rng/kg/day) are considered numericallyequivalent; therefore, no
 attempt was iriade to adjust either the acute or chronic RfD to accommodate differences in
 exposure duration.
 I	f!	   •'	 .ti*;.™  •	ft.I,,';	; | ;;,!",,;;; ' ;  '; J'  ,  • , ;'' ] • '• .   "  „  ;,  !/ ,1   ,' .i,  '.  '"'..'• '^ i'':.'"•'	ll,, ii!.'	''   „  "	Illli' ', 2= . "2,
        The population adjusted dose (PAD) refers to an RfD which has been adjusted to take into
 account the FQPA safety factor.  The RfD is calculated by dividing the NOAEL by the
 uncertainty factors. Numerically, the PAD is defined as the RfD divided by the FQPA safety
 factor. For captan, the RfD equals the PAD, since the safety factor is IX.
 	   	   		 , 	    !  	      h  	f M 	jj	    	          n ,;al ;	J! n
        To estimate human cancer risks, the Agency recommended a linear, low dose
 extrapolation approach for captan. Based on intestinal tumors in mice and using a (body
 weight)3"4 scaling factor, a Ql* of 2.4x10'3 (mg/kg/day)'1 was calculated.

                            (2)    Studies Used to Support the Endpoint Selection

        DevelopmentalToxicitv in Rabbits (MRID 4182690D

        In a developmental toxicity study, 20 New Zealand White rabbits per dose group received
        either 10,30, or 100 mg captan/kg/day by oral gavage from gestation days 7 through 19.
        Maternal NOAEL/LOAEL were considered to be 10 and 30 mg/kg/day, based upon
        reduced body weight gain, decreased food consumption and anorexia. Developmental
        NOAEL/LpAEL were considered to be 10 and 30 mg/kg/day, based upon increased
        skeletal defects (27 pre-sacral vertebrae) in fetuses at 30 mg/kg/day. There was  increased
        post-implantation loss, reduced mean fetal weight, and altered growth at 100 mg/kg/day.
        	                                                             I
        The endpoints selected are based on the developmental toxicity NOAEL of 10 mg/kg/day
        W^
 ri!', ••   , •'	r "inn   •,,1,'iiiin  ' i  	;•„•• -	"vi/i'	(	  ,t.  >,'  '•»  •. ,,   '  «. .°;  ,i .r	  	   ,        •  •	•	
                                                                                                             III,: ''ii .,/„.,
                                                                                                            ^'> " '	'
                                                             -i I;!"1; i1' "    ( ',   , ii1   ':!'   '<• V! '( "I1"!!1:1!"1 i'.W Sit	'
                                                              ' '. i •    '. wl11 ' ,'"• ''"',   ,' .  ;	 ;	f' Mfj'Pi'i- ''.;>j fii	
                                                             ,„::•;	!;"' ;..  VK' r.;i'. • •  ' :,,..'!  '• ' •	'"'  ! r. ':llll, ii«''l<-	"•
                                                          10
                                                                                                       i,." I1' i> "'nJIIII1 < ' ;|;i	if "II,1


-------
 One- and Three-generation Reproductive Studies in Rats (MRIDs 00120315 and
 00125293')

 In both studies, captan was tested in COBS CD rats. In the one-generation study, captan
 was tested at 6,12.5 or 25 mg/kg/day.  This study showed no effects on parents or pups
 at 6, 12.5 or 25 mg/kg/day. The NOAEL for pups was determined to be 12.5 mg/kg/day
 as a more protective endpoint for pups.

 In the three-generation study, captan was tested at 25, 100, 250 or 500 mg/kg/day. The
 maternal toxicity NOAEL and LOAEL were considered to be 12.5 and 25 mg/kg/day,
 respectively, based on decreased body weight gain and food consumption. The offspring
 toxicity NOAEL and LOAEL were considered to be 12.5 and 25 mg/kg/day, respectively,
 based on decreased pup and litter weights. Pup survival was reduced at 250 mg/kg/day
 and higher dose levels. Parental toxicity was observed at 100, 250 and 500 mg/kg/day,
 which indicated a NOAEL of 25 mg/kg/day.

 The endpoints selected are based on the NOAEL of 12.5 mg/kg/day with decreased mean
 litter weights observed at the next higher dose level of 25 mg/kg/day. The one- and three-
 generation studies are  acceptable together and the two studies also show that pups and
 parents are equally sensitive.

 Oncogenicitv Rat (TVIRIDs 00120316. 00129157. 00129163. 00129164. 00153207)

 Two carcinogenicity studies were performed on rats. In the first study, Charles River CD
 strain rats were fed diets containing 0, 25, 100 or 250 mg/kg/day of captan for 2 years.
 The NOAEL for systemic effects was 25 mg/kg/day. At the LOAEL of 100 mg/kg/day,
 males displayed: hepatocellular hypertrophy; increased relative organ weight for kidneys
 (males and females); increased relative organ weight for heart, brain, liver and
 thyroid/parathyroid (males) and decreased body weight.  At the same dosage, females
 displayed: increased relative organ weight for kidneys and decreased body weight.  There
 was a significant increasing trend in males for the combined adenomas and carcinomas of
the kidney in male rats. There was no increased incidence of renal cortical/tubular cell
 neoplasia in females.

In another carcinogenicity feeding study, Wistar rats were fed diets containing 0, 6.25,24
or 98 mg/kg/day of captan for 30 months. The NOAEL/LOAEL for systemic toxicity
were at least 98 mg/kg/day. There was no increase in the incidence of renal
cortical/tubular cell neoplasms. There was a slight but statistically significant increase in
uterine sarcomas in the high dose group.
                                    11

-------
                                                                         i,1"*!!1!	X,	/ml' 1IM1 'Hi 'Will I
                                                                            J./	F
iiiiiii
 liillli I     Mill
 Oncogenicitv Mouse fMRIDs None and 00068076')
                                                            I

 Three carcinogenicity studies were performed on mice. In the first study, B6C3F1 mice
 were fed diets containing 0, 900, an'3 2,406 mg/kg/day of captan for 80 weeks followed by
 jio treatment for 33 weeks. The NOAEL for systemic toxicity was 900 mg/kg/day and the
 LOAEL for systemic toxicity was 2400 mg/kg/day based on decreased mean body weight.
 Male and female mice had an increased incidence of combined duoclenal adenoma/polyps
 or adenqcarcinomas at 2466  mg/kg/day, with the first reported tumor at 91 weeks. There
II I   III 111  _  	[I'll	Ill" Jill;1"	 "	i'SIJ "I, 	lilCM	Ml ! "i-	>K	 >„.<.'	 ,. ••	 ',,	• •	ill	 .•	Ł	,•	::,'	]	 ,	,	, • I.J, 	  	,!!.',	•	
 was a minimal increase in hyperplasia of the duodenal mucosa noted in the high dose
 rna|es (National Cancer Institute, 1977. Bioassay of Captan for Possible Carcinogenicity.
 Technical Report Series No. 15).
                    In a second study, ICR derived CD-I Charles River mice were initially fed diets containing
                    0,2000,6000 or 10000 ppm of captan for 4 weeks.  Subsequently captan concentrations
                    we^ln^'a|s'e/i'Ip'0,'	6000,10000 or "16000 ppm (900," 1500 or"24dO"mg^cg?day for	
                    females and 900,1000 or 2460 mg/kg/day for males) for the remainder of the study. The
                    NO AEL for systemic toxicity was not established. The LOAEL for systemic toxicity was
                    6666 ppm, the lowest dose tested, based on decreased body weight gain and food
                    consumptiOfi (no quantitative information was available). There was an increased
                    incidenge of small intestinal (primarily duodenal) adenomas/polyps and carcinomas at all
                    dose levels. A positive dose-related trend for an increased incidence of duodenal tumors
                    in both sexes was also observed.  Proliferative duodenal changes appeared to occur earlier
                    in the high-dose males. There was also a statistically significant increase in gastric and
                    duodenal hyperplasia in both sexes and in jejuna! hyperplasia in females. This study
                    satisfies the tpxicplogical data requirement for a carcinogenicity study [83-2 (b)] in mice.

                    In a third study, Charles River CD-I mice were fed diets containing 0,15, 60,120, or 900
                    mg/kg/day and the study was terminated at 22 months due to increased mortality in the
                    high-dose males.  The NO AEL for systemic toxicity was 120 mg/kg/day and the LOAEL
                    for systemic toxicity was 900 mg/kg/day based on increased mortality in males and
                    reduced weight gain throughout the study hi both sexes. There was a small increase hi
                    small intestinal tumors (benign and malignant) in the male and female high-dose groups.
                    The results of an Agency audit of this study suggested that there was a problem with
                    achieving and mahitainingthe appropriate dose levels throughout the study. (MRID
                    00126845)                 "'"	'	"  "	'	"	"	  '	
            I  |        | ||    11 '                "'ii	  ,	<  "	 • • in ii' 	,  	', >,,:  J ,   '",,  ';„„ 'JLi'i,,  , V	 	II, ,

                    Using Oral Studies to Approximate Dermal and Inhalation Dosing

                    Oral endpoints are used for all risk assessments. These assessments assume that captan is
             absorbed through the skin at 0.4% per hour of the dosage that would be absorbed orally during
             the same time period. The assessments also assume that captan is taken up through the inhalation
             pathway to the same degree as oral ingestion; i.e., this standard assumption indicates that
             absorption by the inhalation and oral routes are considered to be equivalent.
Ill" !,:•!   	!!'

 :!!"1	';!' It
                                                                               I •	"
                   •1'I'ir
                                     12

-------
                      b.     Acute Toxicify

        Acute toxicity values and categories for captan are summarized in the following table:

        Overview of Acute Toxicity
Guideline
81-1
81-2
81-3
81-4*
81-5*
81-6*
'Test \ - >
Oral LD50 - rat
Dermal LD50 - rat
Inhalation LC50 - rat
Eye Irritation - rabbit
Dermal Irritation -
rabbit
Dermal Sensitization -
sodnea pig
i
MRID
00054789**
40021401**
00148070**
00128621
40021401
00054791
Results
LD50 = 9 g/kg (M)
LDSO > 2 g/kg
LC50 = 0.72 mg/L (M)
LC50 = 0.87mg/L(F)
Irreversible corneal opacity
at 21 days in unwashed eyes
Not an irritant at 3 days
Moderate skin sensitizer
Category
IV
III
m
i
IV
N/A
               Data pertaining to acute eye irritation, dermal irritation, and dermal sensitization are not
               required to support reregistration of the active ingredient. Data are presented for information
               purposes.

               The acute toxicity endpoints, listed above, are for informational purposes only. The data
               supporting these endpoints do not meet current acceptability criteria. The acceptability status of
               these data may be reassessed during product reregistration.

                     c.      Chronic Toxicity/Carcinogenicity

       For human cancer risk assessment, the Agency recommended a linear, low dose
extrapolation approach for captan. Based on intestinal tumors in mice, a Q/ of 2.4xlO'3
(mg/kg/day)"1 was calculated.

       The Agency has classified captan as a B2 (probable human) carcinogen based on an
increased incidence of intestinal tumors hi mice.  Captan was also found to have caused an
increased incidence of renal neoplasms in male Charles River CD rats and an increased incidence
of uterine sarcomas in Wistar rats.

       The Captan Task Force has submitted several mechanism studies for captan. The Agency
has reviewed these studies and determined that they do not contribute any additional information
to the mode of action nor have any bearing on the cancer risk assessment. Similar mechanistic
type studies have been reviewed and considered by the Agency for folpet which has a common
metabolite, thiophosgene, with captan.  Following review of these data, the Agency reaffirmed its
decision and that the linear low dose extrapolation model should continue to be used for risk
                                            13

-------
          i	i	;i;,	11	j	LI
                                                 	]',	ifi,"'"4» • • , , 	ii1 ! ";'" '„ 	  "'•'" •" ' 'hi
                                                 •'•*:$*•	n;:;1: ,	^'\<	"	[<;'	',';•..:  -,
''•••v	•*;;;!	It;
	?;'.;	i!;
           assessment. Therefore, a reconsideration for captan according to the 1996 Draft Cancer Risk
           Assessment guidelines was not required.
                                         Metabolism
   .in;;!, 	•	fit
                 ThgAgency evaluated the metabolism of captan based on several studies. A rat
          metabolism study evaluated the breakdown of captan in mammalian species. Two plant, one
          lettuce and one tomato, metabolism studies determined how parent captan is metabolized by
                      '  	I'!	"i»	ill	i	.'"•'•' •'.',•.-   .•. '•   •?
             |||||||||l||l i i |||||ll III	I  OHk' 	»	II	'"!'	•	I	•'•"	9	•'•	'*' •	' •	'	I	»	•ly-Ml'..	i	.5	!A/'il	"'•	'.'	•:	1~	• '•; inn»	,vs	•	 ™> '.	• 	; . "  j.
              crops. In addition, two animal metabolism studies, one poultry and one ruminant, determined
              what metabolites may be present in animals that have consumed captan-treated forage and feed
              products.
                                                                                I
                    The first step in Hie metabolism of captan is the cleavage of captan's N-S bond to form
              fefrahydVopSmalmiide(THPI) and a derivative of the trfchlorometEylthioside chain. This
              cleavage frequently occurs in the GI tract, though it may also occur in the blood. THPI and the
              trichloromethylthio side chain are each further metabolized through independent pathways.
                                                                                i	
                    For the pathway involving the trichloromethylthio side chain group, four metabolites are
              formed, including the highly reactive species thiophosgene. Although much of the toxicity of
              captan is attributed to thiophosgene, this moiety is not likely to be found in tissues due to its short
              half-life, and therefore, captan is regulated as the parent compound itself.
              TII	ill' '''in;	'Haiti /iliiiiT.iiiiiiii; nv.!':'!!!!]1!,,!)-
                                                                                                !!' Jl 'HIII.III11  •illtillTl  I
                 For the THPI pathway, a total of 7 metabolites are formed.  Unlike thiophosgene, THPI is
          stable enough to be found hi total captan residues. Heretofore, the tolerance expression for
          captan for all commodities has included only the parent compound.  Because captan is extensively
          metabolized to THPI in animal tissues, the tolerance expression for captan residues in animal
          Commodities should include THPI as well as captan. Since THPI comprises less than 10% of the
          total captan residue for plants (based on metabolism studies), the tolerance expression in plant
          RACs and processed commodities should remain as capta&per se.
                 For purposes of non-cancer dietary risk assessment, the combined residues of captan and
                        2. ....... Dose Response Assessment

                        siijii r •'••. :,-a.     Special Sensitiviiy of Infants and Children (FQPA Safety
                       11/! ....... u ,1:11 ....... ui:1, ...... : '
..... iii'" i*1!;! \«
ill ..... to.
                          , ..... ......... ^(         .....  ....... .-• .......     ;.!,r... ...... * ........ -i .....  .......  ........          ..... -^ .....
                 FQPA directs the Agency to "ensure that there is a reasonable certainty that no harm will
          result to infants and children" from aggregate exposure to a pesticide chemical residue in setting
          and reassessing tolerances. The law further states that in the case of threshold effects, for
                                                      14

-------
 purposes of providing this reasonable certainty of no harm, "an additional tenfold margin of safety
 for the pesticide chemical residue and other sources of exposure shall be applied for infants and
 children to take into account potential pre- and post-natal toxicity and completeness of the data
 with respect to exposure and toxicity to infants and children. Notwithstanding such requirement
 for an additional margin of safety, the Administrator may use a different margin of safety for the
 pesticide residue only if, on the basis of reliable data, such margin will be safe for infants and
 children."

       In determining what safety factor is appropriate for assessing risks to infants and children,
 EPA considers all available reliable data and makes a decision using a weight-of-evidence
 approach. This approach takes into account the completeness and adequacy of the toxicity and
 exposure data bases, the nature and severity of the  effects observed in pre- and post-natal studies,
 and other information such as epidemiological data.

       There are no data gaps for the assessment of the effects of captan following in utero
 and/or postnatal exposure. Prenatal developmental toxicity studies hi hamsters and rabbits, and
 two reproduction studies in rats (a one-generation and a three-generation study considered
 together) were submitted in support of captan reregistration and were judged to be acceptable.
 The Agency has determined, based on a weight-of-the-evidence review of the available data, a
 developmental neurotoxicity study is not required for captan.

       The available studies demonstrated no indication of increased quantitative or qualitative
 sensitivity of rats, rabbits or hamsters to hi utero and/or postnatal exposure to captan. In the
 prenatal developmental toxicity study in hamsters, delayed ossification and postimplantationloss
 occurred at 400 mg/kg/day (the developmental LOAEL), while hi dams, decreased body weight
 and mortality were observed at a LOAEL of 200 mg/kg/day. The developmental NOAELs for
 maternal and developmental toxicity in the prenatal developmental hamster study were 50 and 200
 mg/kg/day, respectively. In the prenatal developmental toxicity study in rabbits, the maternal and
 developmental NOAELs were equivalent (10 mg/kg/day). Fetal findings (an increase hi 27th
 presacral vertebrae, a skeletal variation) were observed at the same dose level (30 mg/kg/day)
 which caused maternal anorexia and decreased food consumption and a decrease of over 128g hi
 mean maternal body weight.  In combined results of the one- and three-generation reproduction
 studies hi rats, both parental and offspring LOAELs were established based upon decreased body
 weight at 25 mg/kg/day.

       The selection of a developmental endpoint for risk assessment, has no bearing on the
 conclusion that captain does not cause an increased susceptibility in the developmental studies.
Assessment of increased susceptibility is based on the evaluation of both the quantitative and
qualitative aspects of the effects seen hi the fetuses  in relation to those seen hi the dams (i.e.,
whether the developmental findings were seen in the presence or absence of maternal toxicity, and
whether the observations hi dams and fetuses indicate, for example, differential severity of toxicity
or the potential for long-term consequences).  The acute nature of developmental effects observed
                                           15

-------
i	i? :>
i nil IP, •	liny!1
  , , ,H  ,
 Ilki	a
 ;B;i::ii	i  'I	j;	
 j-illllllllili ''f,."."'"	IP
lit 1" Ji	 ! 1 	i!. Ill III
          	r	I,''I	F
               toxic dose are attributable to the	life stage of the organism; i.e., that the fetus is
                    period of rapid cellular differentiation, proliferation, and organization.
                                                                     •f i- J
                                                                    ,.| I1'.' <"',;  ', 	   •"••. ';	' ^.'W
        In summary, the results of these studies demonstrated that toxicity to the offspring
 Occurred at equivalent or higher doses than parental toxicity, indicating that there is no
 quantitative susceptibility. Additionally, a comparison of the treatment-related findings in the
^Htanimals.anH'in their offspring, as described, did not indicate a qualitative difference in the
 relative severity of the response to treatment by the offspring following perinatal exposure at the
 LQAELs. Tjierefore? the Agency has determined that the 10X factor for enhanced sensitivity to
 infants and children (as required by FQPA) for captan should be removed (reduced to IX).
 ..         ,, .,   ,...     ,             .    ,,       -'
ijii!!|!:;  ' i',  :"", i,,!:'  ail „«?.;,: , f. >... ?,,  "   ' i; j j. •"	lii;f	i	:	• j;, ii. / '.Si )llli:,:. • r,;,  ." s ,	m »•  "	i n f (••••,.. •;>	dfc •,.  •:" • •; •... •.	.•'..,  ...i • •;•' .. ••! a	;
        Exposure methodologies were not found to indicate a concern for potential risk to infants
 and children. This determination was based on the following information: 1) the dietary exposure
 assessment for captan is a refined, realistic estimate of what is likely to be consumed; 2) captan
 residues are primarily surface residues and are likely to be removed by peeling, washing, and
 cooking; 3) the models used to assess drinking water exposure to captan are considered to
 pfbvide fealistic"but somewhat conservative estimates; and 4) although some assumptions used in
 the residential exposure models are modified to better reflect the use patterns of captan in the
 home, the result is likely an over-estimate of exposure.
i""!1 , ••  ';/'".!'!  ''.	f"!1'  '''''dt ,'''.  .in,1"!;	V u	:	'•, " 	•,   i ;;,  ''  -' n.ii:	™.	'.ii,.	;>\ i.ji1'1 T»"'iijf": - '•.. 'jiii,,, i-jiii1! " ":'t" '• /•!•  v	• •'''.*•'• r'.Tji'.ik'it
              3.     Dietary Risk and Exposure From Food

                     a.     Summary of Residue Data Requirements

        All data requkements for magnitude of the residue hi plants have been evaluated.  All data
 are adequate to reassess captan tolerances in light of canceled and revised uses. Field data on
 fruit and nut orchard crops and grapes are available reflecting multiple foliar applications of
 wettable powder, flowable concentrate, or dry flowable formulations with appropriate PHIs and
il|i!l||i!ll'1Pi''',!' ill  '  '" .III t
                                                 I inn i in I ill I  ill nli ih nil ill n
                                                                                                       111111II11  HI I	||

-------
        Adequate methodology is available for enforcement of tolerance residues of captan per se
 in/on plant commodities. A GC/electron capture detection (EC) method included in PAM, Vol. II
 as Method I is the preferred enforcement method. Other methods in PAM Vol. II that use
 colorimetry to analyze surface residues from plant tissues are not acceptable. THPI is completely
 recovered through Protocol D, but not through Protocol E (PESTDATA, PAM, Vol. 1,
 Appendix, 8/93).

                     b.     Summary of Risks from Food

        The Agency has conducted three separate dietary analyses to determine the risk from
 captan in foods on an acute, chronic (non-cancer), and chronic (cancer) basis.  Commodities with
 canceled registrations or for registrations for which tolerances have been recommended for
 revocation were not included hi any of the analyses.  Residues of captan plus the metabolite THPI
 were included in the anticipated residues for chronic (non-cancer) exposure and acute exposure in
 meat and milk. Because the metabolite THPI is not considered carcinogenic, the cancer risk
 assessment was conducted using only the residues of captan per se.

       To assess acute dietary exposure, the Agency conducted an acute probabilistic dietary
 (food) exposure analysis using the Dietary Exposure Evaluation Model (DEEM™). Residues in
 food items were estimated using residue field trials, USDA/PDP and FDA pesticide monitoring
 data, and reduction/concentration factors when available. The acute analysis evaluated the dietary
 exposure based on individual consumption data from USDA's 1989-1992 Nationwide Continuing
 Surveys for Food Intake by  Individuals (CSFII). For acute assessment, exposure was compared
 to the acute population adjusted dose (aPAD). The acute probabilistic dietary risk for captan is
 below the Agency's level of concern. Dietary exposure for females 13-50 years at the 99.9th
 percentile is 36% of the aPAD.

       To assess chronic dietary exposure, a DEEM™ chronic exposure analysis was performed
 using anticipated residues and percent of crop treated information to estimate the anticipated
 residue contribution (ARC)  for the general U.S. population and 22 subgroups.  For the chronic
 (non-cancer) assessment, exposure was compared to  the chronic population adjusted dose
 (cPAD). The chronic non-cancer dietary risk from exposure to captan does not exceed the
 Agency's level of concern, with all population subgroups having exposure values <2% of the
 cPAD. To the extent that this analysis uses anticipated residues, percent-crop-treated information
 and not published (recommended) tolerances, it is not a "worst-case" picture of the chronic
 dietary exposure to captan.

       The dietary cancer risk does not exceed the Agency's level of concern.  The upper bound
 dietary cancer risk for the U.S. population was estimated to be 1.3 x 10'7 from all food uses of
captan supported for reregistration. The upper bound cancer risk from captan is below the level
that the Agency generally considers a concern for excess lifetime cancer risk.
                                          17

-------
  I!,: i f	!•;*
           :;i iiiu	,"i
                                                                                                    II 111 II 11(11
              Summary of Dietary Risks
ih;,»,»!"  'MI ir
 i"	 	'il; i
Mil, 'il!
'I1'1*"•'" "lii'ii!
i	f;irv	
m M
/u,
+'!	'
j><	
 ft
	Ill, i i"
Risk Type
Chronic
Cancer1
Acute
Population
Anticipated Residue
Contribution
U.S. Population
Infants
U.S. Population
Females 13-50 (99.9th percentile)
Exposure;1
(mg/kg/day)
0.000664
0.001629
0.00005
0.036
% PAD or
cancer risk
0.5%ofcPAD
1.3%ofcPAD
l.SxlO'7
36% aPAD
Iff ,=1;. ;,,!	$fr ; asf	I	I]»l« • •,;:•;,«; f f	„   $/  |:S ;„;> ,, ;;, ,;;,.; :•• ,:„ : |.i(, ;  ; 	>* • ;i;|J;} Ł |.;	(j	•; 4 :,>::> ,;' •;»
                                                                                              .''.""l    *
iii"! 4 i;	l!l ,  	• iS
       , i „: •	;,' 3!H^ til •f	iTf • -I.'	s,, •	1" Mi	*	, '	i! ii'	(*il •• ;	•, •;. "" • :s;.   • • - ?.;. • 'Ł,'»*••• •«, i	:ri i i ^:. • * t-Ht-- • r. ;•  ,:;'.	•  • i • \ •. •" >«'' i:;
       The acute dietary risk assessment for captan used the latest percent crop treated, revised
anticipated residues, average residues from field trial data and/or monitoring data, and residue
reduction/concentration upon processing. The acute probabilistic dietary risk for captan is below
the Agency's level of concern (% Population Adjusted Dose <1QO%) for the Females 13-50
subgroups at the 99.9th percentile of exposure.

                     c.      Dietary Exposure from Drinking Water

       To asseis the risk posed to human health from consumption of water containing captan
ffesidues, the Agency conducted three separate risk assessments to account for acute, chronic
(non-cancer) and chronic (cancer) exposure.  Each of these assessments used identical estimates
|orthie expected concentration of captan in drinking water from both surface and groundwater
dljiirc^  IBased on these assessments, the Agency has 3etermine3 that the consumption of
drinking water containing residues of captan is not a concern.
                    Groundwater
                       ill llll»:"!!!lilili III! 'Illlllvii
                                                                   "I" Hi1! ' .«„. "' llillir.il.:.!'
                    The Agency has modeled groundwater resources using SCI-GROW.  SCI-GROW is
             based on the fate properties of the pesticide, the application rate, and the existing body of data
             from small-scale ground water monitoring studies. Since the model assumes that the pesticide is
             applied at its maximum rate in areas where the ground-water is particularly vulnerable to
             contamination, the estimated maximum concentration derived using SCI-GROW should be
             considered a high-end to bounding the estimate of acute exposure.

                    The SCI-GRQW model (ver. 2.0) predicts that groundwater concentrations of captan and
             TBPl residues are not Ipcely to exceed 3.4 ug/L. The SCl-CrR'iDW estimate was based on the
             maximum captan application rate of 32 Ibs ai/A per year (8 applications of 4 Ibs ai/A, 8
             applications of 2.26 Ib ai/A for THPI), aerobic soil metabolism half life of 1.3 days (an average
             half life of 10.7 days for THPI), and a K^ value of 200 mL/g (2.2 mL/g for THPI).
 I!:,:! . in;,.,,;; tr; «  „  IIP:	,'
 iili,!l,,,> lil	,1 ' ,	IIIIIIH.!.1- ,, ' I	i
  r9	1"  ;i!i	, •  Ma* " /-•	',..  jfli, ,$F.
                                                         18
                                                                                                  M^l	i	i!!^;!!*,,, ,1111	1
                                                                                                  	I	J'"1 III' I'lllllilll ""' p  'I
                                                                                                   11 y.!.,, •: •iiiiaiiipi!1'!!,, iiniM"

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        Surface Water

        Due to the range of field dissipation half-lives (2.5 to 24 days), substantial amounts of
 captan could be available for runoff to surface waters for a few days to several weeks post-
 application. Most captan runoff is expected to occur via dissolution in runoff water as opposed to
 adsorption to eroding soil. Based on its environmental fate properties, captan should not persist
 in surface waters under most hydrological or chemical conditions.

        The major captan degradate of toxicological concern, THPI, exhibits low soil/water
 partitioning (K^, values < 1), indicating that most runoff will occur via dissolutionin runoff water
 as opposed to adsorption to eroding soil. THPI degrades at rates comparable to those of captan
 (relatively rapidly) under aerobic conditions.

       The State of Illinois (Moyer and Cross 1990) sampled 30 surface water sites for pesticides
 at various times from October 1985 through October 1988. Captan was included in the analyses
 because of its substantial use in Illinois. Total (dissolved and adsorbed to suspended sediment)
 captan was not detected above a detection limit of 0.05 ug/L in any of 580 samples collected from
 the 30 sites sampled.

       The Agency also used computer modeling (PRZM-EXAMS) to estimate captan residues
 at a single surface water site over multiple years. Based on the model predictions and the
 environmental fate characteristics of THPI, the Agency predicts that THPI will reach drinking
 water from the current use pattern. Each site represents reasonably high exposure and was
 simulated over 36 years. The Agency recommends that 668 ppb be considered as a conservative
 estimate for acute surface drinking water levels of THPI.  The average chronic level for 365 days
 (1 year) is 10.8 ppb.

       The Tier 2 estimated environmental concentration (EEC) for captan is 4 ppb for peaches
 90-days after application. Since THPI is not considered a carcinogen, surface and ground water
 EECs (4 ppb and 0.02 ppb, respectively) for captan per se will be compared to the cancer
 DWLOC for captan.

       DWLOCs for Acute Exposure

       Acute DWLOCs were calculated based on acute dietary (food) exposure and standard
body weights and water consumption figures. These standard values are: 70kg/2L/day (adult
male), 60 kg/2L/day (adult female), and 10 kg/L/day (child). To calculate the DWLOC, the acute
dietary food exposure was subtracted from the acute PAD using the equation:

       DWLOCacutt Cwg/L) = Tacute water exposure (mg/kg/dav) x body weightfeg)].
                           [consumption (L/day) x 10'3 mg/wg]

       where acute water exposure (mg/kg/day) = [aPAD - acute food (nig/kg/day)].
                                           19

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12 ...... ii ....... rift: ""life  -.'•«: ^•.'^••<«T
                               •)«' '-'. ..... i; -I ',: ...... I!" ....... '
-:,« ..... ,-fi ...... t'lv"'' ;• ..... .»,
/n ,,;,.. ft ........ si1 .";    ii >' ..... -• :* ..... ["•:. '-i.
Iii	II	 , '!'! . T	Ill, 111  ,, .,.• ill! , ,; 	'I1	'J*.|.
   A	  Hi' ,	:.  I	[!	""'ii,:'1, '	V	 i	lU'	"W:'•!'',," ". • '   :'  . "   ,«":*:„,	 ,,,,|	I* •	.,'.  ;  /ti	-1;  ,!
                     These cjalculations resulted in the following values:
                                                                                 F 	II"
              Acute Exposure and DWLOC
   ii ''I:|1  !'"' II,
  1!1 JJ1,!'!',, I1 •  ' I11'lii
                     The acute DWLOC of 1920 jWg/L is a far greater value than the conservative numbers that
                 , _. _-culated	for ^the	^c^e^^b^ddng^ water exposure through modeling (668 /2g/L for surface
                    and 3.40 /ig/L for ground water). Therefore, acute drinking water exposure added to the
              acute dietary exposure does not result in a risk concern.
                     Chronic faon-cancer) Drinking Water Levels of Comparison (DWLOCs)

                     Chronic DWLOCs were calculated usmg the same inputs and similar equations as in the
              acute DWLOCs.  These calculations resulted in the following values:
                                                     ,'!;	 ;' "'!„	,| 111'
              Chronic (non-cancer) Exposure and DWLOC
            , {iii
'!!,'' 	 I "' „" ,» 	 IP, 	 ;, 	 ii ' ",,'i
Population
Subgroup
US Population
Infants <1 yr
Chronic
PAD
(mg/kg/day)
0.13
0.13
Food
Exposure
(mg/kg/day)
0.00
0.00
Max. Water
Exposure
(ing^kg/day)
0.13
0.13
»WLOCchroi
^/•:,;<^g/L); ; : :•
4550
1300
VKZM*
.EXA3MS, .
-.; (^g/L)
10.8
10.8
'•f-SGi-;;:'-:.
GRdW
";:(ft^.
3.40
3.40
                                                                        111,'!" I1 'Ml1 'if ' ''I ifl" till':' ,
                                                                                       ,/. ,'. JiliL !' lli;!,,1,!!!!!,,1!,!!;!/ ,,,,,' :,,  It,1!!; ', ........ ij:",:;!1'!11' fl ..... iapl1" ' "i ..... iiiiii.1 ' JlfMi
                     Since these results (4550 and 1300 ^ug/L) are much greater for both populations than the
              |rpurid water and surface water (10-8 ppb and 3.4 ppb, respectivelv) model numbers, chronic
             "^ ' '"'	; w"a"|er with chronic Sietary exposure is not	of concern. "  '	'"  "	

                     DWLOCs for Chronic (Cancer) Exposure
                     To calculate the chronic (cancer) DWLOC, the cancer dietary food exposure was
              subtracted from the upper bound dietary cancer value using the equation

                     PWLOC,.^ fagfL)  =F1 xlQ-6 - food risk^^l  x 70kg/2L/day x 103 Mg'mg,
                                          2.4 xlO'3 (mg/kg/day)-1
             I      It '  "  I1, S , If  JlliJlllll "'I,,,	"  'Ihifll  	    	Illl *  'I* ,  •  ' I	I	„ ',,1 t! ,,,«i:	", ' "'I1:1!,'1!'!1:"1 ,!!t "III  i,'"!|,,,  III1 i,,*11	 i, «i,;,,' ''I'l'"!,1,""' | " „  " ',"	"', |IVl ,.,!•  ii   ,  ,  »,' i ', ,
                                                                          	i 	   	 	
                     where cancer water exposure (mg/kg/day) = [negligible risk for cancer = 1 x 10'6 - upper
                     bound cancer value (mg/kg/day) as Qj* = 2.4 x 16'3 (mg/kg/day)"1.
                         	I"  ,1
                                                          20
                                                                 in!",, :i' ',"!• , 'in,,,   ,','!'	li1,'

-------
        rixlO'6  - 1.3 xlO-7]  x 70kg/2L/day x 103 ug'mg = 13 = DWLOC^
         2.4 x 10'3 (mg/kg/day)-1

        Using conservative dietary exposure values and a conservative equation (male
 consumption is greatest among the three, hence the greatest exposure is expected) a resulting 13
 ppb drinking level of comparison is greater than all the model drinking number values generated
 for chronic scenarios for both ground and surface water (0.02 ppb and 4.0 ppb respectively.).
 Drinking water with dietary consumption is not a concern for purposes of this risk assessment.

                     d.      Occupational Handlers Risk and Exposure

        Occupational exposure to captan residues via dermal and inhalation routes can occur
 during handling, mixing, loading, and applying activities. Postapplication occupational dermal
 exposure is expected during harvesting and scouting activities.

        Based on the toxicological criteria and potential for exposure, the Agency has conducted
 dermal and inhalation exposure assessments for the occupational handler. In addition, the Agency
 has conducted a postapplication dermal exposure assessment for occupational uses.

                           (1)    Scenarios/Assumptions in Occupational Assessment

        The Agency has identified 14 exposure scenarios to represent occupational handler
 exposure during mixing, loading, and applying captan to agricultural crops and non-agricultural
 use sites. These occupational scenarios reflect a broad range of application equipment,
 application methods, and use sites.  The scenarios were classified as short-term (1-7 days) and
 intermediate-term (1 week to several months) based primarily on the frequency of exposure.  A
 long-term exposure duration is not expected.

       The Agency's first step in performing a handler exposure assessment is to complete a
 baseline exposure assessment. The baseline scenario generally represents a handler wearing long
 pants, a long-sleeved shirt, shoes, socks and no chemical-resistant gloves. If the level of concern
 is met or exceeded, then increasing levels of risk mitigation, such as PPE (personal protective
 equipment) and engineering controls, are used to recalculate the MOEs until exposure is
 sufficiently reduced to achieve an appropriate margin of exposure.

       Exposure for all captan use  scenarios (except for potato seed piece treatment and potato
planting) was developed using the Pesticide Handlers Exposure Database (PHED) Version 1.1.
The PHED  was developed by Health Canada, The American Crop Protection Association, and
EPA. PHED was initially released for public use in 1992. PHED is a generic/surrogate exposure
database containing a large number of measured values of dermal and inhalation exposure for
pesticide workers (e.g., mixers, loaders, and applicators) involved in handling and applying
pesticides.  The database currently contains data for over 2000 monitored exposure events. Use
of surrogate or generic data is appropriate since it is generally believed that the physical
                                          21

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                                                	>	i.
                                                                                                      1	11 liliilli !'!' -JI
 I            ll   111|   i I   i    HI    i'llli'li,',;,!
              parameters of the handling and application process (e.g., the type of formulation used, the method
              of application, and the type of clothing worn), not the chemical properties of the pesticide, control
              the amount of dermal and inhalation exposure.  Thus, PHED typically allows exposure and risk
              assessments to be conducted with a much larger number of observations than are normally
              available from a single exposure study.

                     The dermal unit exposures from PHED are reported as the best fit mean to simulate
              Corkers wearing long pants, long-sleeved shirts, shoes, socks and chemical-resistant gloves,
 I    I  II     111 111     I  III 11111   ?   - • 	 •'	 	iff 	-	'i	 •• 	 i-	-,	'	,	, «;	 -  		••

              geometric mean for Ipgnprmal distributed aata, arithmetic mean for normal distributed data, and
              uie median for all other distnbutipn types. The inhalation exposure values are reported as
              geometric means (lognormal distributions), unless otherwise noted. For mixer/loaders of wettable
              powder formulations, an 80% protection factor was included to account for use of dust/mist
              respirators.



                     The Agency is addressing two occupational exposure scenarios associated with the seed
	and seed-piece treatment use:
,	,,,	|	,,, ,|,l  ,' 1|. , 	  hi.	•!'	,11;  ,	,	 .,	,	i	 ,	,	,	|, ,;;	,,,„	,	, , „,!	<;:|lji  ,j|	|.,,,;,.  < ;;„;	 , , 5 , , „ 	|||' 	,,,, ,,	,,,,,„ j,,, 	,,, | 4 |, ,,, „ >,. ,,r <  	",,	 ,  ,  M, |, , ,I;;H ;„„,,„ ,, 	
                     1.     l|u|lc Seed Treatoent:  Tp address occupational exposures while operating
                           commercial or smaller on-farm bulk seed treatment equipment, the Agency has
                           considered a special study conducted in 1980 to assess the potential exposure of
                           workers during seed potato treatment. In that study, the investigators monitored
                           handlers pouring captan into seed hoppers of potato seed-piece dusting machines,
                           handlers  cutting and sorting the treated potato seed-pieces, operators of potato
                           seed-piece planters, and observers involved in the planting operations.

                     2.     Seed Treatment, Planter Box: There are no activity-specific data to address the
                           use of captan as a planter-box seed treatment, at planting time.  To address this
                           scenario, the mixer/loader data for wettable powder formulations available in the
                           Agency's Pesticide Handlers Exposure Database (PHED V1.1) were used. The
                           A'gency determined that soybeans were the crop mo'sf'iikdyforeqiiire'planter-b'ox
                           seed treatment, as most other crop seeds are normally pretreated.  The activity
                           consists of adding a small quantity of captan to soybean seed after it has been
                           loaded into the soybean planter seed hoppers. Captan is either mixed into the top
j:;:,j j^i.1'  . j,'     ii >.      ' •  .f NW	.• |ew mchesof seed to help disperse the captan dust or left alone to be mixed by
                           nonnal shaking of the hopper as it moves through the field. The assumptions used
                           for this scenario include the treatment of enough soybean seed to plant  100
                           acres/day (six-row planter with 30 inch rows planted at 4 mph), and a treatment
                           rate of 0.066 Ib ai/bushel at 1.13 bushels planted per acre. Individuals are
                           estimated to use captan 5 days per year as planter box treatment.



[Mr- [ •"'	r r;.  ,' ilia, -, <. „  * "i m'. i	it	t .;. •	>	•	',;. •,	\	T•.:-i ,•.	;, v • *' *. *" '•• ,97 "	•";	j '":	'  • ";11 • •	•"	"' •' * •'	•	• • •'-'	;;  :;!" -ir	•"	• I
	  	    . 	    , .,,i,  i, ,i	, i  •	ii,   	' ,    „ M    H,	  ,, , • ,i'" , ,  ,  Ł*Ł*                                                   I
nil1!.!"  '.ii mi," i," L ,»' ,i 'W     IIF'.. '      'i'",  	.1'"' liiiiii	 ;;	ll" "V " H, '	ii '  ' 'i '»	     „:• i>   .i,"11.1 n  !•„  'in ,V" 'ii, i"",,;;1 - 'iip1'.1"1!1!1!" ,. , ' s • • mi,  *;:'Hi H " lit, if ii1 •" i' ," |l',,  • "'	iiijni'"! nMn in.*1! • ' ''itlfni i» ,11: f11!!!!1'1'1'! ,•' • •' i, ••' 1
                                        •    .    ..„..,,.,.   ,,     -            \

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        Spray Treatments

        Captan is applied via sprayer to almonds, apples, apricots, blueberries, cherries, grapes,
 plums, strawberries, caneberries, nectarines, peaches, and ornamentals. Captan is applied via
 airblast, groundboom, aerial and chemigation.

        Surrogate exposure data to address handler exposure for these applications are available in
 the Agency's PHED VI. 1.  Handlers are assumed to use captan 7 days per season for strawberries
 and 3 days per season for the remaining fruit crops.

        Almonds and strawberries were considered the crops most likely to be treated by aircraft
 because strawberries are grown in rows and almonds occasionally need emergency treatments
 during periods of extensive rain when ground equipment cannot be used. Although the registrant
 has indicated that treating 350 acres of strawberries by aircraft is unrealistic, the assessment for
 strawberry fields is representative of mixing/loading for all aircraft applications. The Agency has
 determined that, though such strawberry acreage is rare, it is possible to treat 350 acres in a day.
 In addition, almonds are routinely treated in 350 acre increments. Furthermore, the 1994 USDA
 Agricultural Chemical Usage data do not refute the 350 acre estimate. Strawberries are also
 likely to be treated by groundboom equipment and orchard and trellis crops are assumed to be
 treated by airblast equipment. Surrogate data are available to distinguish handler exposure for
 individuals treating dwarf fruit trees and trellis crops, such as grapes, from those individuals
 treating traditionally cultivated orchards.

       The risk assessment for groundboom applications to strawberries is assumed to be a
 reasonable worst-case surrogate for applications to field-grown ornamentals. An exposure
 assessment for greenhouse ornamentals will be conducted only for the hand-held equipment
 scenarios, such as high pressure and backpack sprayers.

       For the high pressure exposure scenario in greenhouses, the Agency assumes one hour per
 day for mixing/loading and applying the pesticide 26 days per year. Although it is unlikely that a
 backpack sprayer could deliver 100 gallons per hour, the Agency assumes one pound ai handled
 per day for 26 days per year.

       Greenhouse soil treatments are similar to the greenhouse foliar treatments. The only
 exception is when the application is directed to the soil around the plants rather than the foliage.
 Therefore, the exposure and risk assessment for applications to greenhouse ornamentals using
 hand-held equipment is a reasonable worse-case surrogate for greenhouse soil treatments.

       Application to Golf Courses

       There are surrogate data available to address application of captan to golf courses. For
this use, the Agency has assumed the use of groundboom equipment, and that a typical golf
course consists of 40 acres  of fairways.  The golf course is assumed to be treated 10 times a year.
                                           23

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                   Ill II
                        ill
•,-,' "1'"
{M'.Iili;
        In-Plant Additives for Paints, Plastics. Rubber, and Adhesives

     !'4R.*Data are available in PHED VI. 1 to address worker exposure to captan used as a
 iigreservative/fungicide^in.paints, vinyl, plastics, rubber, and adhesives. Mixer/loader data available
^glp.^HEip were	used to aHd^ss workeE^adding captan during the manufacturing of these
 industrial products, since these uses appear to be similar to those of an agricultural mixer/loader.
 Captan is weighed then added to the various products which are typically made hi batches (e.g.,
 paint). Although plastic and vinyl are relatively inert, captan is used to control molds attacking
 plasticizers (such as ethylene glycol), which are added to enhance the properties of plastics such
 as toughness and flexibility.
                                                                -::.:	1:,,
        According to information available:"af the time of thePD2/3, capstan's use as an additive to
 industrial products was very limited. It was anticipated that an even lower market share could* be
 expected in the future.  Exposure scenarios addressing the addition of captan into specialty paints
 having pesticidal claims and into adhesives to promote longer shelf-life were selected as
 representative scenarios for the industrial uses.

        jpor, captan formulated into paint products, a rate of 12 Ibs ai/100 gallons paint was used,
?"'fidith a totalof 36 Ibs ai/day ad3ed.  The use of captan 'inthese products is reportedly limited; mus,
lliIllH" *	Illlillin^^^^^	IICIIII 11.'.	1.SW.1T	 	 	K	r	 -T 	 J.	 '	  '
 EPA estimates that workers will be exposed 10 days per year.

        Commercial painter exposures while applying paints containing captan were also
 estimated,  The commercial exposure assessments were conducted using PHED Vl.l.  EPA
 estimates that commercial painters are exposed 15 days per year for 70 years. The painter
 assessment is used as a reasonable worse-case surrogate for other secondary handler exposures to
 products such as adhesives.

        Post-Harvest Fruit Dip Applications for Apples. Cherries, and Pears

        There are no activity-specific data to address the use of captan as a postharvest dip
 treatment for apples, cherries, and pears to control spoilage during storage and transit.  The main
 activity is the mixing/loading of captan into the dip/drench tank.  Most of the application is
 mechanized and involves relatively low exposure potential. These activities include overseeing
 the apples being conveyed in and out of the dip/drench area, and operating forklifts to convey
 field boxes or bulk bins of fruit for dipping or storage. Dipping the fruit by hand involves
 relatively high exposure potential. Although EPA has no data to assess ^e exposures and risks
 from hand  dipping, these data are being c"^le^ m with this RŁ?fj.  xhe only data available in pfjgJD
 VI .1 to address this scenario are those for the mixer/loader handling a wettable powder. This
 activity is assumed to result in the highest exposure.  In the PD 2/3, it was determined that a
 mixer/loader wquld prepare four batches per day for a period of 6 weeks (in West Virginia) to 32
 weeks (in Washington state).  The dip tank sizes are assumed to range from 1000 to 3000 gallons,
 which amounts to 30-160 days exposed per year.
                                                         24
             H'!	

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                            (2)    Occupational Handlers Risk Conclusions

        A single non-cancer endpoint effect was identified for both dermal and inhalation
 exposures. For certain handler activities, dermal exposure was assumed to occur once daily and
 subsequent absorption was assumed to result from a single exposure event where residues remain
 on the skin for 8 hours and are absorbed at 0.4% per hour. For other handler activities, dermal
 absorption at 0.4% per hour was assumed to result from continuous exposure for 8 hours during a
 single day. MOEs below 100 for combined dermal and inhalation exposure represent a risk
 concern for the Agency.

        Most short- and intermediate-term risks to handlers using captan are above 100. MOEs
 that are above 100 range from 240 to 43,000. Of the risk estimates for the 14 scenarios, only
 three were below 100:  mixing/loading wettable powders for aerial applications and chemigation,
 use by professional lawn care operators, and handlers loading wettable powders for seed-piece
 treatment.

        For mixing/loading to support aerial applications and chemigation, the Agency has
 determined that inhalation exposure is a large component of the combined dermal and inhalation
 exposure estimate. These risks can be mitigated with the use of water-soluble packaging, in
 which case the MOE of 41 becomes 1000. Alternatively, application rates could be reduced to
 1.21bsai/Aorless.

        To estimate cancer risk, inhalation exposure was combined with dermal exposure to
 provide an equivalent oral dose for comparison against the Qj* 2.4 x 10'3 (mg/kg/day)-1. No
 handler risk exceeded 5.9 x 10'6.  Most handler scenarios have cancer risks in the 10'7 and 10'8
 range, which do not exceed the Agency's level of concern for occupational handlers.

                           (3)    Occupational Incidents

       Captan is in Toxicity Category I for primary eye irritation and is a moderate skin
 sensitizer. According to the information provided in incident reports reviewed by the California
Pesticide Illness Surveillance Program between 1982 and 1990, there were 14 eye/skin incidents
reported for reentry workers, 14 eye/skin incidents reported for mixer/loader/applicators, and 10
eye/skin incidents reported for other activities such as dipping flowers, preparing root and bulb
dips, moving recently treated seed with forklifts, and exposure to spray drift.

      There are many uncertainties associated with eye/skin incidence reporting and the
Agency's ability to mitigate these adverse effects. Some of the uncertainties include:

      The majority of incident reports are associated with pesticide applications that are applied
      as tank mixes. These tank mixes often involve other active ingredients which may also be
      irritants or sensitizers;
                                          25

-------
, 1'il;,,l,;1"  ,1'	i,!	!'!
	 ••• ;,,,,,ii	W 'tfilliii:
lUlll'L 	IT I"' iilllU'J I,!
                                                                             SIMi :|	I,!1 ,„  "iT,"!i II, '"'H
                     Symptoms such as conjunctivitis and irritation can be caused by soil, sweat, and foreign
                     Objects such as plant material irrespective of any pesticide used;

                     Eye incidents are typically under-reported for reasons such as fear of employer reprisal,
                     migrant workers not wanting to attract attention to themselves, and the cost of medical
                     treatment; and
liiiK'";::,	i 	iiiKiii'iiii	  I/it i  i M^.	j?..^«ff	"." ,,, ' ' , n1 «„ fi   >     '* i,,, "»  ,•,  'j,, ,•   	H'VI i,, '."rUf' i|:;,,| '  i '.Ifilii, : ,; ' ,   'i 'i .11, "I I"'11 . ,'!!' ,'   ,,'"i,, ,  ;|. 	I'l  ".i[. jl,,,1 i! !;' 	IIJIP Jli,1' .U,1

                     Average work day interval represents an 8 hour workday.

                     Average body weight of an adult postapplication worker is 60 kg (non-cancer risk
                     concerns) or 70 kg (cancer risk concerns).

                     Dislodgeable foliar residues (DFRs) represent combined captan and THPI residues; the
                     combined values were used for exposure assessment for short-and intermediate-term risk;
                     THPI was not included in the exposure for cancer risk.
	)|'	Mi	11" Tiili:'" t,  , I;,.!' "' ' <"
                            ' ' "IJI
                                                           26
lllllli'l'i'il'Ji,:!	Jll	I
                 ui
                                   ,'li'lllll.i1 II

-------
                            (2)    Occupational Postapplication Risk Conclusions

     .  To estimate non-cancer risks, MOEs for various REIs were derived by a comparison of
 dermal exposure estimates against a NOAEL of 10 mg/kg/day for intermediate exposure.

       To estimate cancer risk for harvesters, the Agency assumed 80 days (national use) and 120
 days (California) for the number of days exposed per year, and 35 years of exposure over a 70
 year lifetime. The Ch* of 2.4x10'3 (mg/kg/day)'1 was used to calculate risk.  The assessment
 shows risks ranging from 1.8 x 10'5 to 7.7 x 10'6. The assumption of 80 to 120 days of exposure
 to 24-hour post application residues is conservative. The risks presented are considered a worst-
 case scenario because they do not address percent crop treated or typical rates. Actual risks are
 expected to be much lower.

       The REIs that will be established are:  12- hours for seed treatment uses; 24-hours for
 strawberries, almonds, apples, apricots, cherries, nectarines, plums/fresh prunes, and peaches; 3-
 days (72-hours) for blueberries, raspberries, blackberries, and grapes; 4-days (96-hours) for
 ornamentals, and 24-hours for soil treatments.

                    f.     Residential Exposure and Risk

       Residential exposure to captan residues via dermal and inhalation routes can occur during
 handling, mixing, loading, and applying activities.  Postapplication residential dermal exposure is
 expected during gardening or other recreational activities. Based on toxicological criteria and
 potential for exposure, the Agency has conducted dermal and inhalation exposure assessments for
 the occupational and residential handler, and for occupational and residential postapplication
 dermal and inadvertent oral ingestion exposure to adults and/or children.

       Potential captan residential use sites may include lawns, ornamentals, fruit trees, and
 strawberries. According to the National Home and Garden Pesticide Use Survey Final Report,
 Volume 1  (March, 1992), the major use of captan in the home garden is on edible food crops
 (about 65%), followed by roses and other ornamentals (about 26%), and lawns (about 8%).  It is
 available to the home gardener as dust (D), wettable powder (WP) and emulsifiable concentration
 (EC) formulations containing captan at 6 - 50% active ingredient. Captan is also incorporated   •
into paints and adhesives as an industrial preservative.

       Equipment for residential uses include low-pressure handwand, hose-end sprayer,
backpack sprayer, and shaker can.  In addition, powders or dusts may be mixed dry with
vegetable seeds hi a bag or jar prior to planting, or mixed with water to form a solution for
dipping root cuttings, bulbs, and corms to prevent seed rot or damping off.
                                          27

-------
       i.: ii'1!,, "  •»"••!	iiiilK • iijl1'!!!1!!1	ili|. /'I'M!;; ' ii'lli I  'diiiiiiH ' li, ( M	"  ' i f rtj	 "'   • ^i:"!!'" ,'in, , ; 	i,,,     '  '• ":  „..',«•   Ji1 J'"!:!1',,,, "!|!,i , 'iiiiiik, i i  ''"iiP!:, 'i,:;1               -I1  I    I
       	   ,  	   	 	jn h	 , , ,  	     ,  	   , ,     ,   ,n  	   , , ,,..	i   , „.  I
, lira,,i'.. n	u ' F. ' ,11111111  '„ ,,  Hi'.;, i HI JIM" ii'uiny" 'Hi.;",i i  : inHiii i,'i • j;  "mir >    r	'HI, .	i iii. •   „   •i||i|i»iii   \  'v^y'i" '  	,i,   ,.  i	• »t mi1 ,, ,r« • .«i iim1"" • I               •"
! IE:;! iii 11 ri'j".. jiiiisi  vi •!!  nil1'! r jiiiwji1 , T": mil1: '•• „ ..Bin  :; wi! mi: i,:1 »•  i '..ii	•  .yimr111! -• 'I,,.;!..'!.' »i	n,  , ii •  "i1 ,  ni|i H,*'1 ,,''" n*" •  /'i'"1,,:1"1"  "'.i ,!•,,, i'*", '11.	*• ., 	i,,!>i':	i
                             	liiiil! 	ililiin ;i. ;;'.,• .||	'",    • :, '  ':,,. Tun, ' i1 ," , I,,,,   ,  • i  , '''ii'1,,!!"!  ,J
                              "iii ' mi"! ""','!." nil,'„ 'i','i ,ii,,,!,ii.,,, ii, ' » !„ ,:• •'!!',!,. in™ liknlriifi »'•:  in,.!!' 1>\ ,.;i,,, ' ,'"ii'iiiiiiii1 ''iiiJi'"''""iiii'i1.:,,,.i, b'viii	i'!i.iii< „ .,"1'1'iiii'iiw'',',1               n.
                             ", •;',,"':; •„,:;-.'';' ;•:':,'" i,;:i:: ,(1)     Residential Handler Risk

                      Captan may be applied at 7- to 14-day intervals throughout the growing season; however,
               the duration of exposure is expected to be short-term (1-7 days) for residential handlers because it
               is unlikely that home gardens would require continuous daily applications for a period of time
               greater than one week. Short-term risks to residential handlers dp not exceed the Agency's level
               of conceml MOEs range from 240 to over 100,000.
                                                          ii
                      Cancer risk estimates to residential handlers do not exceed the Agency's level of concern.
               The results of the cancer risk assessment indicate that risks for all residential handler scenarios are
               jn the 10'7 and 10'8 range.
           	' 7..!J	,	",I	~...' ™,I  ! ,	  '..',..'	 ',	!,!	,,"11^ 	'  ,'.",  , ,'	'".  "'	",.'..'	".'	~Z	'."	"|	'	'. '.  . 	!,.	,'.'."	!.
                                           (2)    Residential Post-application Risk

                      Although captan may be absorbed through the skin or respiratory tract,  postapplication
               inhalation exposure is expected to be minimal for all. residential scenarios, including applying
               captal-Sealed paint Only dermal exposure is expected for postapplication harvesting activities.
               Based on the half-life of captan residues on leaf surfaces (10 to 43 days), the duration of
               postapplication dermal exposure is expected to  be either short-term (1-7 days) or mtermediate-
               term'(i"week"to	several'"months").

                      The Agency is concerned about toddlers exposed to captan Ihrough residential uses on
               lawns.  The MOE for  toddlers' hand-to-mouth contact from residues on  low-growing plants is
               approximately 11.  The MOE for toddlers' hand-to-mouth contact from residues on turf is 2.  To
               mitigate this use, thei technical registrants have agreed to voluntarily cancel the use of captan on
               all turf, except at sod farms and golf courses. To ensure toddlers are not exposed to residues of
               captan on treated sod, the Agency is establishing a 48-hour harvesting prohibition interval.
                                                                                     i
                      Based on the currently registered maximum application rate to turf, MOEs are 20 and 25
               for adults and toddlers, respectively., However, when the application rates to turf are reduced,
               these risks are effectively mitigated and MOEs  for both groups are above 100.  MOEs for dermal
               exposure hi treated gardens ranged from 2,000  to 45,500.

                      Derrnal postapplication exposures and risk to youths and adults playing  golf at golf
               Bourses diiilpt exceed the Agency's level of concern.  The Agency determined that the MOEs are
               110,000 and180,000 for youth and adult golfers, respectively. This assessment assumed 4 hours
               of play for 18 holes of golf.

                      Cancer risk estimates from postapplication exposure do not exceed the Agency's level of
               concern. The results of the cancer risk assessment indicate that risks for all assessed residential
               postapplication scenarios are in the 10"7 and  10"8 range.
                                                           28

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                     g.     Aggregate Risk

       In examining aggregate risk, FQPA directs EPA to take into account available information
 concerning exposures from the pesticide residue in food and all other exposures for which there is
 reliable information. These other sources of exposure can include pesticide residues in drinking
 water, exposure from pesticides uses in and around the home, and exposure in non-residential
 settings, such as, parks, schools, etc.

       Acute Aggregate Risk

       An acute aggregate assessment estimates risk from one day's exposure to food and water.
 Acute exposure (food only) to captan was 36% of the aPAD for females 13-5Q years of age (the
 only population of concern for acute exposure), which does not exceed the Agency's level of
 concern. Since drinking water monitoring data for captan were not available, drinking water levels
 of comparison (DWLOCs) were calculated and compared to estimated environmental
 concentrations (EECs) that were generated by the PRZM-EXAMS and SCI-GROW models. The
 EECs for surface and ground water were less than the acute DWLOCs, indicating that acute
 aggregate exposure to captan does not exceed the Agency's level of concern.

       Short-Term Aggregate Risk

       Aggregate short-term risk assessments provide estimates resulting from residential
 exposures of 1 -7 days duration, plus food and water exposures. Typically, high-end residential
 exposure estimates are added to estimates of food and water exposure for comparison to an
 appropriate NOAEL from a toxicity study. For captan, the developmental and maternal toxicity
 endpoint of 10 mg/kg/day from a developmental toxicity study is used for short-term assessments.
 Three major aggregate short-term exposure scenarios were considered reflecting the turf,
 ornamentals/fruit trees, and paint additives uses of captan.  Exposures to golfers was not included
 in the aggregate assessment because the risks posed by this scenario is expected to be negligible.

       Use of captan on turf results in postapplication exposures to children which exceed the
 Agency's level of concern, based on hand-to-mouth exposure. Because any additional exposure
 via food or drinking water would only cause risk estimates to further exceed the level of concern,
the Agency concludes that aggregate short-term exposures resulting from use of captan on turf
 exceeds the level of concern.  These uses are being voluntarily canceled to mitigate this risk.

       Residential exposure from use of captan on fruit trees/ornamentals or from painting does
not exceed the Agency's level of concern when aggregated with food and drinking water
exposure. Aggregate exposure scenarios include application residential scenarios. The painting
scenario is calculated for adults only and assumes that children do not paint.
                                          29

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                                              11 •:; .< iFirvafii.; if'1.a
            ^Aggregate !^ho'rt-Term kiskis'for Captain
 '	lii ) BBS..

                Scenario
              Ornamental/
              Fruit Tree
              Airless Paint
              Sprayer
                             Mixer/Loader/Applicator
 Exposure
(mg/kg/day)
        0.029
        0.025
MOE*
   345
   400
                                Food
 Exposure
(mg/kg/day)
     0.0007
     0.0007
MOE
14,300
 14300
                                       Total
 Exposure
(mg/kg/day)
       0.03
      0.026
MOE
  330
  390
                                                                                                   DWLOC
2,100
2,220
            ^Exposures compared to NOAEL of 10 mg/kg/day from Developmental Toxicity Study in Rabbits.
                                                                                     ii
                           Allowable short-term water exposure (mg/kg/day) x body weight (kg)
                                  water consumption (L/day) x 10'3 (
       i   i  lllllll ill  l i      i lil i  I i i           ill          i      l i    ii    1 1    l in hi (  1 1
            where Allowable short-term water exposure =NOAEL/UF - chronic food exposure - residential exposure
            ji$ OMI example, exposure to adults who are mixing/loading/applying to ornamentals:
       i     i  in      i i i    n i   i i               n     i       i          in i  in    i i n     i
            Allowable short-term waterexposure = (10/100) - 0.001 - 0.029 = 0.07 mg/kg/day
 II ....... "Ill     I Hi IT    '    I! .......... I ...... *         "      i       .......      iiii      ..................
            0.07 rng/kg/day * 60 kg - 2.100 ppb DWLOCCT adult females
 i  "  'I I"     0.001(mg/|ig)2L/day                                                                          ..................
                                                                                     j
                    Chronic (Non-cancer) Aggregate Risk
                                    ..................... ............................. .........  , h     ..................................... ......................  .....   I i , •, , .......................
                   A chronic aggregate assessment estimates risk from long term exposure to food and water
            and also includes residential exposure if any long term scenarios are identified. No chronic non-
            cancer exposure scenarios are expected from residential uses of captan.

                   DWLOCs for chronic dietary exposure were discussed earlier in this document. The
            calculations indicate that DWLOCs greatly exceed estimated environmental concentrations and
            therefore there is no concern for chronic aggregate food and water exposure.

                   Chronic ("Cancer) Aggregate Risk

                   Aggregate cancer assessments estimate risk from lifetime exposures to food and water
            plus residential exposure. Multiple residential exposure scenarios may be included in aggregate
            cancer assessments if they have a reasonable probability of occurrence over a lifetime. As hi the
            previous aggregate assessments, exposures to golfers was not included because the risks are
            expected to be negligible. Risks of 10"6 or less are considered to be of negligible risk concern for
  1      ''"  "ffie general population. ................................
            !»""   '"•   i  in    mi i    i i  n   in        ,' i'  ;  ..fw  ,n' -, ' L ,•'"',' 1 1  ,„ ' '..,"'• «•,»'' , ' l'ii'  • ' ".'"!, ''lii IM f 'i'! 'SB 'i 4'. "• '"'r ..... h M " "«!•>'• !,;,"' 'i  ': "' '''iivii r • „  "'"""
                   The following table illustrates aggregate cancer risks associated with some residential
            exposure scenarios. It should be noted that use on turf is not included in the table because
 1  |      r "  Ii}] lii  f, "ir ...... ", ,;, , .............. , ..... :ll .......... ....... ......... >'  ..... „' ............... ................... Ill ........... ............ ', ..... ..... »  ,;„ ............ ........................ »   , ..... ......... „  ..... " ...... "I,; II ....... "i ..... ,11,.' ...... ..nr, "... ..................... ll ........ ..... Ii:, ...... ,,i,  ', 'I", 'I   i  ,   , , ....... II
            goncancer risks .were npt acceptable by themselves for turf uses of captan.
                                                                           ihltl illii'l il111111!!;!!!! .idl'nl"11!'1" NI||I|II|||| I
                                                                       illll! , ri 111,	IIHIlllilii,       I
                                                           30
hi,;	lit,,,,,!:!;1!! •, €!  n.'r **:•:i;ifii
                                                                              .If
	i	

-------
 Aggregate Cancer Risks for Captan
? * Residential Exposure Activity
Primary handler - Mixing/loading/applying
wettable powders to fruit trees
Secondary handler - Painting with a brush
Postapplication - Ornamentals
Residential
Cancer, '
Risk
6.5x1 0-7
8.5 x ID'8
4.2 x ID'8
.Food
Cancer >
Risk
1.3 x 1C'7
1.3 xlO'7
1.3 xlO'7
Aggregate
.Food and
Residential
7.8 x lO'7
2.2 x lO'7
1.7 xlO'7
.DWLOC^
PPb
3.2
11
12
 DWLOCC!mCCT=  Allowable water risk x body weight (kg)
           Q," (rag/kg/day)'1 x water consumption (IVday) x 10'3 mgig
 Allowable water risk =10-*- Food risk - Residential risk
 Example: Painting-with a brush
 Allowable water risk = 10* - 1.3xlO'7 -8.5x1 ff8 = 7.8 x 1O'7
 	7.8xlO-7*  70kg	 = 11 ppb  DWLOCto^
  2.4 x ID'3 (mg/kg/day)-' * 0.001 mg/jig * 2 L/day

       Water models predict environmental concentrations of captan in ground and surface water
 of 0.02 ppb and 4.0 ppb respectively. A DWLOC ^^ greater than 4.0 ppb is obtained for any
 residential scenario (or combination of plausible scenarios) with a risk estimate of less than
 2.3x10'7.  Although mixing/loading/applying wettable powders to fruit trees is associated with a
 cancer risk of 6.5 x 10'7, this risk level still only yields an aggregate risk of 1.05 x 10'6. Therefore,
 no residential aggregate scenario is of a concern to the Agency for cancer.

       Captan and folpet share a common metabolite, thiophosgene, which is believed to be
 responsible for the carcinogenic effects of these compounds.  Thiophosgene is a highly reactive,
 short-lived species. Studies indicate that thiophosgene causes local irritation of the site with
 which it comes in contact, and is believed to cause tumors through the irritation of the duodenum.
 Because they are so short-lived, thiophosgene residues cannot be quantified. Without measurable
 residues of the common metabolite, it is difficult to relate exposures of captan to those of folpet
 since the rate of formation of thiophosgene may be different for both compounds. However,
 assuming that the carcinogenic effects observed in both pesticides are due solely to the metabolite
 thiophosgene, the Agency believes it is reasonable to add the estimated cancer risks from the
 individual aggregate risks from both folpet and captan to obtain a worst case estimate. For
 captan, the dietary cancer risk estimate for the US population from exposure to residues in/on
 food is 1.3 x 10-7. For folpet, the dietary cancer risk estimate for the US population from
 exposure to residues in/on food is 9.8 x 10'8. If these two risks are added together the total risk
is 2.3 x 10'7  The aggregate cancer Drinking Water Level of Comparison (DWLOC,^ ) based
on this total cancer risk estimate is 11 ppb, using the captan Qj* of 2.4 x 10"3. The estimated
environmental concentration (EECs) for folpet are 1 ppb (sw) and less than 1 ppb (gw). The
EECs for captan are 4 ppb (sw) and less than 1 ppb (gw). The largest EEC of 4 ppb is less than
the DWLOC, the Agency's level of concern. This aggregate assessment is for dietary exposure
                                            31

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 only. The tumor of concern occurs in the GI tract (duodenum/jejunum-ileum)as a result of oral
 dfising- The relevance of dermal exposure to a GI tract tumor is unknown at this time.  Thus, the
 Agency concludes that an aggregate cancer risk estimate considering dietary (food and water)
 exposure only for captan and folpet based on their common metabolite thiophosgene is
 appropriate.
 HiliiiiiiihJ'l"!;, jii,"'1!!!!:!!. ,i" "IHijli
iijllhf'	L, ill , 	11 i'i'i,',»i,!  	'
Kill	ill!	71. „, Jill!!? I, 'ill
              e.
                                 Cumulative Effects

       Section 408(b)(2)(D)(v) of the Food Quality Protection Act requires that, when
considering whether to establish, modify, or revoke a tolerance, the Agency consider "available
information" concerning the cumulative effects of a particular pesticide's residues and "other
substances that have ^common mechanism of toxicity." The Agency believes that "available
information" in this context rnight include not only toxicity, chemistry, and exposure data, but also
Scientific policies 'and methodologies for understanding; common mechanisms of toxicity and
conducting cumulaSye rislc assessments.  For most pesticides, although the Agency has some
information in its files that may turn out to be helpful in eventually determining whether a
pesticide shares a common mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues concerning common
mechanism of toxicity in a meaningful way. EPA has begun a pilot process to study this issue
."forther'through the examination of particular classes of pesticides. The Agency hopes that the
results of this pilot process will increase the Agency's scientific understanding of this question,
such that EPA will be able to develop and apply scientific principles for better determining which
chemicals have a common mechamsmp         and evaluating the cumulative effects of such
chemicals. The Agency anticipates, however, that even as its imderstandingof the science of
common mechanisms increases, decisions on specific classes of chemicals will be heavily
dependent on chemical specific data, much of which may not be available at present.
       At this time, the Agency does not know how to apply the information hi its files
concerning common mechanism issues to most risk assessments; however, there are pesticides for
which the common mechanism issues can be resolved.  An example of this would be pesticides
that are toxicologically dissimilar to existing chemical substances (in which case the Agency can
conclude that it is unlikely that a pesticide shares a common mechanism of activity with other
substances) and pesticides that produce a common toxic metabolite (in which case common
mechanism of activity will be assumed).
       FQPA requires the Agency to consider the cumulative exposure to pesticides operating by
a common mechanism of toxicity.  Policy to permit the estimation of cumulative exposure is
c(urren,tly under development but is not yet complete. At such time as policy defining how to
conduct a cumulative ^assess^aent has, beenfealized, 'the risk assessments of captan (and folpet)
will be revisited to determine whether a common mechanism is operative with any other pesticide
and, if so, whether a cumulative risk assessment is warranted.
                                           32

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        C.     Environmental Assessment

               1.     Ecological Toxicity Data

        In addition to estimating risk to human health, the Agency also assesses risks to terrestrial
 species and aquatic organisms, including avian species, mammals, and fish. The exposure and risk
 estimates that follow represent major agricultural use sites and reflect both the range of terrestrial
 and of aquatic non-target exposure scenarios expected with the use of captan on terrestrial plants.

                     a.     Toxicity to Terrestrial Animals

                            (1)     Birds, Acute and Subacute

       In order to establish the toxicity of captan to avian species, the Agency required an avian
 single-dose oral (LD50) study on one species (preferably mallard or bobwhite quail); two subacute
 dietary studies (LC50) on one species of waterfowl (preferably the mallard duck) and one species
 of upland game bird (preferably bobwhite quail).

       The results reported in the following tables indicate that captan is practically non-toxic to
 the Northern bobwhite quail and mallard, on both an acute and subacute dietary basis.
Avian Acute Oral Toxicity Findings
Species
Northern bobwhite
Mallard Duck
•i
%aa.
Tech
Tech
LDSO mg/kg
> 2,150
>2000
Citation
GSO 120-045
GS9999-001
* * i
Toxicity Category
practically nontoxic
practically nontoxic
Satisfies'
- Guideline
Yes
Yes
Avian Subacute Dietary Toxicity Findings
• - Species
Northern Bobwhite
Mallard
Mallard
Northern Bobwhite
Northern Bobwhite
% a.i.
Tech
Tech
90%
90%
Tech
*AO
ppm
> 2,400
>5000
>5200
>5200
>4640
Citation

00022923
00022923
43869803
43869802
00104686
'„, Toxicity Catego'ry * >, ","
t _* ^
slightly toxic or practically non-toxic
practically non-toxic
practically non- toxic
practically non- toxic ,
slightly toxic or practically non-toxic
Satisfies
Guideline
Yes
Yes
Yes
Yes
No
The studies are acceptable and fulfill guideline requirements. (MRIDs 43869802,43869803
GS0120045, GS9999001, 00022923, 00104686).
                                           33

-------
                                          (2)    Birds, Chronic

                     Since captan has repeated exposure through multiple applications, avian reproduction
              studies are required. The avian reproduction studies for captan indicate ttjat exposure up to 1000
              ppm in the diet does not affect reproduction. Multiple foliar applications of captan result in peak
              maximum predicteS residues slightly above Iob"6" ppm, however, wnen th'eexposure and risk are
              further refined to consider concentrations and methods of application, the resulting predicted
     iiii i ii ii    , ill 11,11  in Him ill	liiiiii i lit •	iii	i	i	in ii	i"ii iii i iii	i	n	i  ii1  ' 	i	4X	'	.,	,, °,f,	,,.,,	,	
              residues are below this concentration- Therefore, no further data are needed and the guideline
              requirement is fulfilled. This issue is further discussed in the Exposure and Risk to Nontarget
              Terrestrial Ajiimals; section. (MRIDs 00098295,00098296).
                                                                                   !
     i         	      	       I,   i (3)    Mammals, Acute and Chronic
     i   i ii     1 11          ii 1111  i ii i 1 ii  in  nil    i ii      i  ii  1 i i ii inn        ill  1111 i ii   inn 111       i i  ii i    i       i   ii  i nil
                     Mammal testing was not required by the Agency's Ecological Effects Division since
              captan is not acutely toxic.  Mammalian data are reported in the following table.

                     Mammalian Toxicity Findings	

                            Speeds          Tes.Type         ^         LOBLppm    ''ggg

 | liK^f:	' il:! I'"',  : f ij|j||!;J.i: .1r v '11  Rat	Acute oral	LDsp 9g/kg	00054789
                       Rabbit              Developmental         330              990         41826901
 iiiSt ,11,. 1C	ill!'1!!!	'  ' ""!„  if;. ,„ !'!!'„-	|	
                       Hamster	Developmental	2000	4000 incr. resorption  00086803
                       Rat	One generation	>500	>500	00120315
                       Rat                Three generation        250       500 reduced pup wt   00125293
           j _,*,;!;ji•;; 'i,,,.;'4|ib,j^^     ijsi	:»^^        t,,	;	nf'», "''	i";,v"I*':^:itMf ,•'	M^KiliE!'.u";'f' J*: JHfl:':f'^ls'&tfi":^! W"i 11 ill?I	!::'I'J?
                     TJie acute oral LD50 was used to determine toxicity. The mammalian data indicate that
              captan is practically non-toxic to the rat on an acute oral basis (jyfjyjj QQQ^J^
           	   '                                                                  I                	" '	

 •ill	.'Ki	E!	Ill	•».' 11,!,!.	1	1	 Ill	II  "il'll 	lull	V '       n^i|S         II        ill i       I    i	,y.,.,.	i,,,:,

                     A lisaey bee acute contact LD50 study is required when the proposed use will result in
              Jipjiey bee exposure. Studies on the honeybee using technical captan indicate that the LD50 is
              greater than 10/zg a.i./bee, and that there is 9.8% mortality at 215 /^g a.i./bee.  There is sufficient
            r  ^utfprmation to characterize cagtan as relatively nontpxic to honeybees. The guideline requirement
WEIM..I	i	::*»:; i!iii:;y as	jj^fg ^««^ ^QQ ^ ^	
                                                                          II1
                                                          34
In,"!   it	

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                     b.     Toxicity to Aquatic Animals

                            (1)    Freshwater Fish

       In order to establish the acute toxicity of captan to freshwater fish, the Agency required
 two freshwater fish toxicity studies. Both a coldwater species (preferably the rainbow trout), and
 a warmwater species (preferably the bluegill sunfish) should be used.
Freshwater Fish Acute Toxicity Findings
., Species
Bluegill sunfish
Bluegill sunfish
Fathead minnow
Brook trout
Coho salmon
Harlequin fish
Brown trout
% a.i.
90
88.4
88.4
88.4
90
89
90
96-hr IAo
ppb ai
310
72
65
34
137
300
26.2
Citation "
(MRID)
GSO 120042
00057846
00057846
00057846
40098001
05020144
40098001
Toxicity.Cate'gory
highly toxic
very highly toxic
very highly toxic
very highly toxic
highly toxic
highly toxic
very highly toxic
Satisfies'
Guideline
Yes
Yes
Yes
Yes
Yes
No
Yes
       The results of the 96-hour acute toxicity studies indicate that captan is highly to very
highly toxic to fish.  The guideline requirements are fulfilled for testing with technical material
(MRID GS0120042, 00057846, 40098001, 05020144).

       The Agency waived the acute formulated product testing with a 50% wettable powder
(WP) formulation since the confidential statement of composition for the captan 50 WP and 80
WP end use products showed that the major and minor inerts are not likely to enhance the toxicity
of captan.

       Degradate testing was required because captan is short-lived (hydrolyzes at pH 7 hi about
6 hrs) and the major degradate(s) are believed to be stable and exist at concentrations greater than
10%. The following data were submitted on the major degradates of captan, THPI and THPAm.

Freshwater Fish Acute Toxicity Findings
* \
Species
Rainbow trout
Rainbow trout
% a.i.
96% THPI
95% THPAm
96-hr.LQo
v (ppb)
>120,000
> 126,000
„ Citation
(MRID)
43869806
44738801
~*~ liSr-
Toxicity'Category
" $ , * *
practically non toxic
practically non toxic
Satisfies
Guideline
Yes
Yes
                                          35

-------
  ' I	IIP!	!H!	IB!	I'"
                               I"11;1 :"! ............. ill!!;- '" : f .)MF.W 'Irtli'!' ........ b .......... • ..... • vniiii1 I"1'1 ....... If. ..... ! .......... •'* ....... I!]-11" • iS! ........ !!; ..... .IJtW. .IrK- iC,MI*i' I'" •iB ....... ''•Rlllt UH" , ilsV!
                                                                                           i ..... 'il':!*' ...... ' ..... I1 I1* fW Will ..... t ....... iii ..... !"" iWli':"
III ..... 11
                        IK  ' ..... I
li 11

Hill
11 III
       1 iiiiii
      P	
Illl  11 I  II
                    'J'here is sufficient information to characterize THPI and THPAm as practically non-toxic
             to fresh water fish. Considering these results, bluegill studies will not be required. The guideline
                                    and THPAm are fulfilled (MRIDs 43869806, MRID 44738801).
       A fish full life cycle on parent captan has been submitted, therefore the fish early life stage
study will not be required. The results from this study indicate that fathead minnow growth and
Survival is affected between 16.5 and 39.5 ppb. The jsjQEL is 1S.5 ppb, ariS lie Ii(5ŁL is 39.5
             ppb. The guideline requirement for the fish full life cycle testing is fulfilled (jyiRiD 00057846).
                                        (2)
                                  Freshwater Invertebrates
                    The minimum testing required to assess the hazard of a pesticide to freshwater
             invertebrates is a freshwater aquatic invertebrate toxicity test, preferably using first instar
             Daphnia magna or early instar amphipods, stoneflies, mayflies, or midges. The results from a test
using first instar Dapnia magna are shown hi the following table:
 'ill"    i    H iii    n      iiii                     1 1  i  i in  i  i
       Freshwater Invertebrate Toxicity Findings
::
	 Species
Daphnia magna
Daphnia magna
Daphnia magna
Daphnia magna
%a.i.
Tech
93%
90%
Tech
48-hr. ECso
(ppm)
>7.1
>3.25
8.4
1.3 (26 hr.)
Citation
(MRID)
00070751
43869807
GS0120041
00002875
i
Toxicity Category
moderately toxic or less
moderately toxic or less
moderately toxic
moderately toxic
Satisfies
Guideline
No
No
Yes
No
                    There is sufficient urformatipn to characterize captan as moderately toxic to Daphnia
             'magna. The g^dejŁer~q^—^-g ^
             43869807).
       Since degradate testing is required, data were submitted on 96% THPI (%a.i.) using
Daphnia magna. Results indicated that the 48-hr LC^ is greater than 113 ppm a.i. There is
sufficient information to characterize trie captan degraclate xflpi as practically non-toxic to
Daphnia magna. (MRID 43869808). The guideline requirement is fulfilled. The results of the
rainbow trout study with THPAm demonstrate that the 96-hour LCso was greater than 126 ppm,
and"iie""BCEi was" l2#ppm.'	From these resultsj the Agency	^^^"3 m'at"f HPAm' is  '	
practically non-toxic to the rainbow trout (MRID 44738801), and there will be no requirement to
l^st Ł>gg/zma magna with THPAm.

       Aquatic invertebrate life-cycle testing was required because captan is applied repeatedly by
air blast or aerial equipment and may contaminate waterways via drift and runoff.  Results from a
submitted study using parent captan indicate reproductive effects in Daphnia magna occur at
Rprninal concentrations between 0.56 and 1.0 ppm. This study was conducted as a static renewal;
                    I.	1 •fllllllilli	•IIIIKIiiililil
                                      ,j	Ill  	Illllr,	''T "Ir'l'iMl1
                                                                                                 ,i: 'f!	 , i'L'Ci":1*'!!;
                                                        36

-------
 neither the concentrations of parent captan nor THPI were measured in the test solutions. The
 reduced length and decreased number of young seen at 1.0 ppm are attributed to captan since
 THPI appears to be lOOx less toxic acutely than parental captan. Although continuous exposure
 to parental captan would yield a lower NOEL, static renewal is more representative of aquatic
 organism exposure to captan under field conditions.  Subsequent applications of captan would
 mimic the repeated dosing of the static renewal study. In light of these factors and the greater
 sensitivity of fish, the value added of repeating this study is low. The Agency is not requiring
 additional data at this time. (MRID 44148801)

                            (3)    Estuarine and Marine Animals, Acute

       The foliar use of captan on turf, lawns, and golf courses could result in exposure to
 estuaries and marine environments, and therefore acute toxicity testing with estuarine and marine
 organisms was required.

       The requirements under this category include a 96-hour LC50 for an estuarine fish, a 96-
 hour LC50 for shrimp, and either a 48-hour embryo-larvae study or a 96-hour shell deposition
 study with oysters, using technical captan. The registrant has recently submitted two 96-hour
 acute toxicity studies, one using sheepshead minnow and another using saltwater mysid. (MRIDs
 44806504,44806503), and these studies are in review. A 96-hour shell deposition study is still
 required, as an earlier study (MRID 00127865) was conducted using the dungeness crab, which is
 not a preferred test species. This study showed captan to be moderately toxic to  dungeness crab.
 The Agency is not requiring testing using formulated products at this time, pending submission
 and evaluation of technical testing.

                     c.     Toxicity to Plants

                           (1)    Terrestrial
                                              •
        Tier 1 terrestrial plant testing (seedling emergence and vegetative vigor) would normally
 be required for captan due to phytotoxicity label statements (the captan 50WP label indicates that
 necrotic spotting of immature leaves of some orchard crops may occur under certain conditions).
 However, based on captan's use as a seed treatment, and since captan is non-systemic, the
 Agency is not requiring a Tier II emergence study.  In addition, the vegetative vigor study would
 not likely demonstrate the occurrence of spotting on the usual non-woody species. Therefore, the
 vegetative vigor study is also waived.

                           (2)    Aquatic

       Aquatic plant testing is required for captan since it has outdoor non-residential terrestrial
uses and it may move off-site during application by drift.  Testing on the following five species
was required due to effects seen in tests with several algal species using captan: Selenastrum
                                           37

-------

Ill 111  ill
 capricornutum, Lemna gibba, Skeletonema costatum, Anabaena flosaquae, and a freshwater
 diatom. Tier 2 toxicity data on technical captan are listed below:
ill nun mi1      " iiiiiiiiiiii iiiiiii|iiiii "  i J	    r       	     	     	       in
 Nontarget Aquatic Plant Toxicity Findings
==":'"::	—  :,"•"„,:  Lemna gibba
                         Species
                Selenastrum capricornutum
                Skeletonema costatum
                Pavlova lutheri
                Isochrysis galbana
                Scenedesmus subspicatus
                Anabaena flosaque
                               90
                              99.8
                               99
                               99
                              92.7
                              99.8
                                       EC50 ppm
1.77
0.18
0.55
0.21
0.32
 1.2
                                            99.8     12.7 (7-day)
           Citation (MR1P)
                                                                      43869809
                                                                      44806502
                                                                      40228401
                                                                      40228401
                                                                       252586
                                                                      44806501
                                                        44806503
                                                                                        Satisfies Guideline
Yes
Yes
No
No
No
Yes
                                       Yes
                                                                                      II                        '.!
                      The results indicate that several algae species experienced a 50% inhibition in growth at
              Jess ithan 1 ppm (MMD 49228401). Species other than those tested previously are required. The
              registrant has submitted studies with three other aquatic species: Lemna gibba, Anabaena
              Josaquae, and Skeletonemema costatum. (MRIDs 44806501,44806502, 44806503). The
              Agency has sufficient inform       use for me risk assessment, and additional data is not
              required at this time.

                      Though not required by the Agency, the registrant submitted a study with THPI on the
              alga Selenastrum capricornutum. The results indicate that aquatic concentrations of THPI up to
              180 ppm are not toxic to Selenastrum capricornutum. ^MRID 433693 Jo).

                                     Environmental Fate
                                    i    ,,,' ,|i  'i ' ,  	"li • ii Kl!1    " ,•  ' ,    '   •, •   ' i,,  ii||i| 'I  ' In,'1 Hill," '  ,, 'r,:,: ,',,: || "i' •    ,||   "Bliii! " ; i   , •   •„ ,,.»!; 	i. ii ! ""lilllfn,, "ll'ii i"!".	 ."
                                     in || >i> ,; ii!	 HIM' li.'liii' Hull   ' J i ,1" 1, i hi	In,	I,,, |;|l In',11'	lllilil	yi1  , ,., i,|"',,,l"':i!   ''	I'	Mill	l< '<, 111IM|, J'i| ' I 	l":,,, r'  ;" i,:' - M};	7' S'',, |i>;,;" a.'   '  Environmental Fate Assessment
    1 liln:, I  I  ,   1111"",!!, i, ,|'"  ."in,   "li,  ,,' i "I" Illllllllu,,,  ELI m" nil,,!, '"'illi IB"	'"us""",,' ni i','ii, "i"'"	ni'ii"',,, p  "  , ' 4 yi i'"'!•,!"..  ,,'"• *•* ,;,,>   'v*  K: '--ii  ;•".',,':	ra •,,,•.•/• sii,:  , i ;•!••,   ,., ;•,* :i(i*;t.(i,:t!ft; ,:ii,	"".'.sl
                      (Japtan degrades rapidly in the environment'with a half-life of less than one day.
   f iiiiji,'i""'" if I;, :,	|;,	: jiHy drolysis and aerobic soil metabolism appear to be the maj or routes of captan dissipation in the
              envifonment In water and soil, the sulfur-nitrogen bond cleaves, separating the trichloro-
              methylthio (TCMT) and tetrahydrophthalimide (THPI) moieties of the molecule.  The TCMT
              !!|&,,,    , ?•'": '	         I 11  ill1

                                                                                      li
             ,„ llhli'linl;: ILITIillil'III'"',,,,li!"li,''"l,l|ll«i:'i'l	I! I'lillllillllllln, "i  Itll'IIT ',l|i,	Lllliiili," Hill: il""l	Ill ,,,,  < .'III  ',;  , ' ' ; 	,1,1,   	 1,|,  ',", ,'"  ", ,:,'llll	  ,   ,"",,,|llll	.I'll!   , "'I'1',;!, ,  '  m,l,   ,|""l,,	,„:,,",

              	    	    	t	

-------
        Captan photodegradation on soil also occurs, but is secondary to hydrolysis and aerobic
 soil metabolism. Evidence indicates that residues of THPI may be present in soil several months
 following captan application. THPI is potentially mobile and may leach in the soil profile.
 Freundlich.Kd values for THPI ranged from 0.01 to 0.17 mL/g in six soils. THPI may move with
 surface runoff.

                     b.     Environmental Fate and Transport

       Parent captan degrades relatively rapidly. However, there is a potential for the degradate
 THPI to reach ground and surface water due to application rates and multiple applications of
 captan.

                     c.     Degradation

 Hydrolysis:  14C-trichloromethyl captan hydrolyzed in sterile aqueous buffer solutions at pH 5, 7,
 and 9, with half-lives of 18.8 hr, 4.9 hr, and 8.3 min, respectively. Two unidentified degradates,
 both of which degraded rapidly to 14CO2, were detected in the study (MRID 41176301).

       Two other hydrolysis studies were also reviewed.  One study (MRID 00096974) provided
 information on the hydrolysis of 14C-carbonyl captan, and described the fate of the ring portion of
 the molecule in sterile aqueous solutions at a pH range of 2-9.  Another study (MRID 40208101)
 provided acceptable information on the hydrolysis of 14C-trichloromethyl captan at pH 9. Taken
 together, these three studies fulfill the data requirement. (MRIDs 00096974 40208101
 41176301).

 Photodegradation In Water: Because hydrolysis, not photolysis, was responsible for captan
 degradation in an aqueous photolysis study reviewed previously, the Agency concluded that the
 photodegradation in water data requirement for captan would be fulfilled upon submission of
 acceptable hydrolysis data for pH 5. The Agency concluded that captan is stable to photolysis hi
 aqueous  solution at pH 5. No additional data on the photodegradation of captan in water are
 required at this tune (MRIDs 40208102 and 41176301).

 Photodegradation on Soil: In studies where 14C-captan labeled in the cyclohexene and trichloro-
 methyl positions was applied to moist sandy loam soil and irradiated with natural sunlight, captan
 degraded with half-lives of 5 and 15 days, respectively. The half-lives for dark controls were 10
 and 21 days, respectively. After 5 days of irradiation of 14C-cyclohexene captan, 21.3% of the
 applied radioactivity was present as tetrahydrophthalamide (THPI) and 9.4% was present as
 cyclohex-4-ene-2-cyano-l-carboxylicacid (THCY). No other single degradate contained more
than 3.2% of the applied radioactivity. For 14C-trichloromethyl captan, the only reported
degradate was 14CO2, which comprised 41.7% of the applied radioactivity after 16 days of
irradiation.
                                           39

-------
'•Kill "1111, , I T!	P'li'l'ili,', HIILilllili
        The sgll photolysis data submitted are acceptable and fulfill the data requirement. No
  additional data, for captan photodegradation on soil are required at this time (MRID 40658009,
  40658010).
i IIKi'UKUiilUI1 :., ''ij'.'PH '"I ,,'iii! 	I'1 li'l •!!!•',,,, liMiiHil • I* I ,' MM!;" JH !	I Ilillli!1 IIM1,"	' ::•'!!!''":,„"".• "".nil,'•''!,'•• «	'. '!" Illn'll „• If1 Ik » ,,iii.'l Jjljjjjjj!!!jjj,Ljjjjjjjjjj!!"!IVl|:'Ji. lj!lljjjjjjjiljjlll'U|1, "i'ljjj'jj	 |	'W'll'*' '' ' "' I"'Wii'in!"!' 'l:''!li.iL|!!l' M I'1 JS''"''jl: I	W Vl'	L 'PI •' •!'» '!' 'F'lJjWMj'ii , f y	jjjjjjjji ; ; "< »	ri 	unnpi	 111511 ;|n ||||||ii|||« 'i||i||n ft ' 	'i ; i, • ,n r»' ||M ' • T	L   i	n  ijiji	,	•»• t ,i<"i, 	i.,	

	~*•'"*lil ~  '•'•' ""*'";	'!!!'""'•""'In'anotner anaerobic soil'rrietabolism stiidV, carbonyl-fabeled [^]C captan was completely
              degraded after one week of anaerobic soil conditions.  Qualitative reporting of results indicated
            -•that four metabolites, including THPI and THPAm, were detected with very little 14CO2 evolved,
	' -;	''-''-'" :	- ^miplyin'g mat me" degradates formed wer^
              00098881).
                                                        40

-------
 Aerobic Aquatic Metabolism: This study determined the fate of captan and degradates in
 water-sediment systems with two contrasting types of sediment. The Old Basing water system, a
 method for extracting test sediment, included clay loam at a pH of 8.0 with 12.5 % organic
 carbon, and the Virginia water system included a loamy sand at a pH of 6.2 with 3.1  % organic
 carbon. The application rate was chosen to simulate accidental spraying into a water body during
 normal agricultural practices.

       The study provides acceptable information that shows captan degrades in the aerobic
 aquatic environment with a half-life of less than 24 hours in soil and water. This study fulfills the
 guideline requirement.  Maximum concentrations of degradates detected, as a percentage of
 parent captan applied, were: 81.2% THPI at Day 0, 27% THPAm at Day 7, 10.8% THPAI at
 Day 14, and 9.4% THPI epoxide at Day 1. (MRIDs 00096974,40114502).

       The Agency calculated the half-life of THPI in the Old Basing system to be 7 days. THPI
 concentrations in the Virginia water system decreased from 51.1% of applied at Day 30 to less
 than 0.1 % by Day 60.

       The Agency concluded that once captan reaches surface water and hydrolyses (within 24
 hours), the degradates (THPI, THPAm, THPAI, and THPI epoxide) probably will not persist in
 surface water longer than 60 days (MRID 43868905).

                    d.     Mobility

 Leaching, Adsorption/Desorption;  Soil thin layer chromotography (TLC) data indicate that
 captan is slightly mobile to relatively immobile in various soils. These data, combined with the
 hydrolysis, soil metabolism, and terrestrial field data (see below) indicate that captan is labile, and
 demonstrate that the parent compound is not likely to leach significantly in soil.

       Two of captan's degradates, THPI and THPAm, appear to have the potential to be mobile
 in the soil and to reach surface water via runoff and/or erosion during periods of precipitation
 and/or irrigation. (MRID 43868911). As further confirmatory data, laboratory data submitted for
 captafol, a pesticide with a chemical structure similar to captan, also indicate that the degradates
 THPI and THPAm are mobile.  (MRID 40658011).

 Laboratory Volatility: Volatility does not appear to be an important route of dissipation for
parent captan. Over a 9-day period, approximately 0.003% of ring-labeled captan volatilized
 from a sand soil treated at a rate of 1 Ib a.i./A. Approximately 3.9% of the applied radioactivity
volatilized from TCM-labeled captan. None of the labeled volatiles were parent captan (MRID
 00160301).
                                          41

-------
 	f'lli'Mf IliK   	


  .ilii1' t'l ilii .lii'llii", > llll	
   1	lllih.rlil. „ i1! ill hliill  : ,


   "Illlllllllllli Jill Jill1"1, llll . F1	
Jill i;,,,'	i:(:•:•„	- raiiiii ir iiiiaii, >IMI|.	, ,,t .j ,c^'-j	t	:!»i|!t!i;-i' •	ii-rj, fir!
 1114	.1H"1?''1!1'  l:li:l;iiiiii 'HIM;1"""'" •'* .;
           ;:;iirii!  .an,	ss !in
               ! jiiV»	i
••'"' t ;iii!.1 ;••:!;: i	;'. i,	«	;	•• ::>* :';i
&$>	Sfii''..fil'ifc.	sllil:	;J'*.V?r;.
                      e.     Accumulation
              : v si iiiii	iiic-iiiiF ,;::: * ,! iiiiiFLi:	Nir nil	'' :«B::I ~"< -u iiijii	iufi-	o  ;	
 'i»r Jiiir; i.t'it!-:,:-a;	'i.-vti >\ •> '•  i**';	irTu,.:1 , :*i •.hiiihii	isu	lib 11* y	
i -, s l *' ;•; • •'" f' IliiVi ";ir:; TO 'f;',, /i „, -i;" :i: Ibii...., , iii'iif ^! J^"'fflMiBI!!S	$ SI I
	ii ill ;F,,: iiiiiinii1''	i" .,'ii';),';:!!;: rv,."; :\.n"~".'   , ',,'ii'"1',,'  •' ii •.! ii1 'Sil11	i	  I

iis, 'i'-'vi'tsi	'^ti^tii&	!"	r! W"- 'K	'r'TMJ	ft^llFi^l

                            .:':. ' 	i	, ' 'i^lliilllrfilill'ljllllllll'- iKf/i */;"::«
                on in ..... Aquatic Organisms;  Two studies, one each for cyclohexene-labeled and
......                  a,' waelreviewed 'and in' dicate that residues 3q "'not ^accumulate substantially in"
 IMegill sunfish. When exposed to a nominal concentration of 5 ug?L of ring-labeled MC-captan
 for 28 days, bluegill sunfish had 14C bioaccumulation factors of Jo2X, 126X, and 1 13X for edible,
 non-edible, and whole fish tissue, respectively. After a 14-day depuration period,  14C-residues in
 edible tissue, non-edible tissue, and whole fish declined by 94%, 96%, and 95%, respectively.
 Degradates in exposure water and fish metabolites were not identified. Accumulated residues
 were largely elimmated during the depuration period.  The data requirement is satisfied and the
 Agency is not requiring additional fish accumulation data for captan at this time. (MRID
 40756601, 40756602, '40225661,  ''         [[[ ""  " .................... ' .......... "'" ........... " ""' ' ...... " ' ................ ..........................
                      f.      Field Dissipation

 Terrestrial Field Dissipation; Six studies were submitted, all of which provide supplemental
 Information.

        Parent captan degraded with half-lives of 2.5 to 24 days and was relatively immobile to
 slightly mobile at six sites. The maximum depth at which captan was detected was 6-12 inches.
 The degradate THPI was detected at all sites and'decirneSto'Iess tnan detectable (070T ppni)
 levels between 14 and 184 days after the final captan treatment. THPI was relatively immobile to
 slightly mobile in the study soils.  Its maximum depth of detection was 6-12 inches.
                                                                      !|
 III IIIII  I     I  I Illlllllll  I 111 111 I II   I II    I    I     I         I  II I    I IIIII  II  I    II I I II      j II     I    I       II 111   I III
        The field studies provide relatively consistent estimates of the parent compound's half-life
 and the rates of formation and decline of THPI. It is unlikely that any further studies of this type
 will change the overall assessment of the dissipation, degradation, mobility, or accumulation of
 captan residues in the environment. Therefore, the Agency is not requiring additional terrestrial
 field dissipation data at this time (MRID 40823901, 40893601, 40893602, 40893603, 40932201,
 40932202).
                      g.     Spray Drift
        No captan-specific studies were reviewed. Droplet size spectrum and drift field evaluation
 Studies (guidlines 201-1 and 202-1) were required since the captan products may be applied by
 aircraft and orchard airblast and due to the concern for potential risk to nontarget aquatic
 organisms. However, to satisfy these requirements, the registrant, in conjunction with other
 registrants, formed the Spray Drift Task Force (SDTF).  The SDTF has completed and submitted
 to the Agency its series of studies which are intended to characterize spray droplet dlift potential.
 Factors whicii appear to affect drift potential and considered in the studies of similiarly applied
 pesticides include application methods, application equipment^ ing|eoroJQg^ca| conditions, crop

-------
       The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and
 State Lead Agencies for pesticide regulation and other parties to develop the best spray drift
 management practices. The Agency is now requiring interim mitigation measures for aerial
 applications that must be placed on product labels/labeling as specified in Section V . The Agency
 has completed its evaluation of the new data base submitted by the Spray Drift Task Force, a
 membership of U.S. pesticide registrants, and is developing a policy on how to appropriately
 apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by
 air, orchard airblast and ground hydraulic methods.  After the policy is in place, the Agency may
 impose further refinements in spray drift management practices to reduce off-target drift and risks
 associated with aerial as well as other application types where appropriate. In the interim, the
 following spray drift related language is required on product labels that are applied outdoors in
 liquid sprays (except mosquito adulticides), regardless of application method:  "Do not allow this
 product to drift."

                     h.     Water Resources

                           (1)     Ground Water

 Modeling

       SCI-GROW (Screening Concentrations in Groundwater) is a model for estimating
 concentrations of pesticides in groundwater and is based on the fate properties of the pesticide,
 the application rate, and the existing body of data from small-scale groundwater monitoring
 studies. The model assumes that the pesticide is applied at its maximum rate in areas where the
 groundwater is particularly vulnerable to contamination. Usually a considerable portion of any
 use area will have groundwater that is less vulnerable to contamination than the areas used to
 derive the SCI-GROW estimates. The model is based on permeable (sandy) soils that are
 vulnerable to leaching and that overlie shallow (10 to 30 feet deep) groundwater. The estimated
 maximum concentration derived using SCI-GROW should be considered an upper-bound estimate
 of acute exposure. If the risk associated with this estimate is exceeded either at the acute or
 chronic endpoints, refinement of the exposure estimate will be necessary to better characterize
 actual exposures.

       The screening estimate was made based on a maximum application rate of 32 Ibs ai/A per
year for captan and calculated maximum application rate of 21.36 Ib ai/A for THPI. The THPI
application rate was derived by multiplying the maximum annual rate of 32 Ib ai/A of captan by
0.66, which is the maximum amount of THPI detected in the aerobic soil metabolism study as a
percentage of applied captan.  The Agency used the aerobic soil metabolism half-life of 1.3 days
for captan (an average half-life of 10.7 days for THPI) and a K^ value for captan of 200 mL/g
(2.2 mL/g for THPI).  The SCI-GROW screening model (ver. 2.0) predicts captan residues of
0.02 yUg/L hi groundwater and cumulative captan residue (captan and THPI) of 3.4
                                          43

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  Ill	Illllllill 'I	Ill	
              Monitoring
       The information from the Pesticides in Ground Water Database (PGWD) provides only a
limited picture of captaris leaching potential.  The PGWD provides the largest compilation of
captan ground water data, detailing results of analyses performed no later than 1990. There are
few data that suggest that captan will leach to ground water as a result of normal agricultural use.
The California.summary in the PGWD does not detail whether the samples taken were from
known captan use areas, or were part of large-scale survey studies.
Captan was not detected in the National Pesticide Survey.  The greatest number of samples were
taken in California between 1984 and 1989. Four samples had detections of captan out of 1158
analyzed with a range of concentrations from 0.1 to 0.5 ppb.
 ill
       1 l ll  	ill1 llPilili:'
                                                               , •  ii	
                                                                                                      sail*1!	       I
Hill	
       The PC|Wl3|ej)orts|hat no captan was detected in 670 samples taken from 7 other states
between 1983 and 1990. However, the study summaries indicate! that the majority were not
specifically designed to sample captan use areas. Survey studies in Illinois, Indiana, Texas and
Virginia were designed to characterize regional ground-water or drinking-water quality. Specific
use of captan was not investigated in Maine, Rhode Island and Oregon.
                     As discussed earlier, the environmental fate data for captan suggests that it would not
              pose a risk for leaching to .ground water. At a pH level of 7.0, captan degrades to THPI by
              hydrolysis with a Half-life of 5 fO g hours. At a pH of 9.6, the half-life is only 3.6 to 8 minutes.
              Thereforef degradation of captan to THPI would begin with mixing of the fungicide with water
              for application.
             iiiiiii     11 in i iiiiiiiiiiiii Mini ii    n    i  lull in  ii       ii   i i   i nil i n iiiiiiiii MI   in i   i i i  1 in  111 n   in in  in  i  |i  in  in
                     Captan applied to foliage will not be immediately available for infiltration into the soil.
              Studies from the• mid-1 ^SO's; addressed the dissipation of captan from foliage, and derived a range
             iSO^,fd!iyesj)f|3	.to 13	days. A further study done on strawberries in California led to a foliar
              dislodgeable residue j^f-life estimate of 9 days. Previous Agency calculations used a foliar half-
               _	ii	H	,	    	r  	S,	J	.	
              life of 10 days. Any captan that reaches the soil surface after application would be subject to an
                  .      . ,			Ł	'IT	-il:,	•	•Ł&		 		•	
              aerobic soil metabolism half-life of less than a day. Therefore, parent captan is unlikely to pose a
             i «llliin, • ".wSniiiiiiiiTnii'rHi n'li1 ~ii'i«lii»Sliii|i5pii	uiiiiiiiii|iiini n, iiiiiiuiiiiiiiuiiiiiin:1 »iip '!iiiiiiiiiiiniiiiiiiiiiiii!liii!''i'liii!3ii iiiiiiiiiiiiiiJiiiniiiiiniiiiiiii	niPiiPiiiiiir.ni ii'r;,,,: i
-------
        Captan is applied foliarly, and has a reported foliar dissipation rate of 9 or 10 days (Willis
 and McDowell, 1987). It also degrades almost completely by hydrolysis in less than a day.
 Therefore, unless significant amounts of captan are inadvertently applied to the soil by drift, or a
 significant rainstorm washes all applied captan from foliage soon after application, all THPl'
 formed will not be uniformly made available for leaching by a single effective application to the
 soil. It is not clear from our data what percentage of parent captan is converted to THPI by
 hydrolysis. However, THPI formed through aerobic soil degradation of captan accounted for a
 maximum 66% of the parent compound in laboratory studies.

        Furthermore, a very small portion of crops (orchard fruit trees) to which captan is applied
 will be grown on sandy soils with very low organic matter. In addition, most crops on the captan
 label have fewer than half of their total acreage treated with captan. The one exception to both
 statements is strawberries, which are grown predominantly on such soils, and which are almost
 universally treated with captan. The potential for leaching is reduced for strawberries by the use of
 plastic sheeting mulch and subsoil drip irrigation. In Florida, one of the major states where
 strawberries are grown, the very shallow depth to ground water makes it very likely that THPI
 concentrations could be found in ground water.

                            (2)     Surface Water

        Due to the range of field dissipation half-lives (2.5 to 24 days), substantial amounts of
 captan could be available for runoff to surface water for a few days to several weeks post-
 application. The relatively low soil/water partitioning of captan for 4 soils indicates that most
 captan runoff will be via dissolution in runoff water as opposed to adsorption to eroding soil.

       Captan is susceptible to rapid abiotic hydrolysis and to fairly rapid microbiological
 degradation under both aerobic and anaerobic conditions. Consequently, it is not expected to
 persist hi surface waters under most hydrological or chemical conditions. Its relatively low
 soil/water partitioning indicates that most of the captan in surface waters will be dissolved in the
 water column as opposed to adsorbed to suspended and bottom sediment.  As discussed earlier,
 the bioaccumulation potential for captan is relatively low.

       The State of Illinois (Moyer and Cross 1990) sampled 30 surface water sites for pesticides
 at various times from October 1985 through October 1988. Substantial use in Illinois was a
 criterion for pesticides being included hi the analyses. Total (dissolved and adsorbed to
 suspended sediment) captan was not detected above a detection limit of 0.05 ug/L in any of 580
 samples collected from the 30 sites sampled.

       The major degradates, THPI and THPAm, exhibit low soil/water partitioning indicating
that most of their runoff will be via dissolution hi runoff water as opposed to adsorption to
eroding soil. Both degrade at rates comparable to those of captan (relatively rapidly) under
aerobic conditions.
                                           45

-------
 Illlllllllllllllllll 11   111 II
                                                                                     II
                       Based on fate characteristics and model predictions, the Agency believes THPI could
               reagli Serfage, djinking water sources. Surface water concentrations were modeled with PRZM2
               and EXAMS using the Georgia peach scenario that produced the highest 90-day aquatic pesticide
               level for captan. Chemical-specific inputs, standard model parameters and the PRZM2 input file
               are available. The results of the PRZM2-EXAMS simulation of THPI concentrations resulting
               from maximum label use-rate of captan on peaches are shown below.
                                                                        "	"T
Avei
rage THPI Concentration d
Frequency (years)
1/10
•Peak'' :
668
jpb)
96-Hour
385
21-Day
123
66-Day
50.9
'" '.•90-l^ay'::/:"
34.1
'^T'S'Searly ;-':•'.
10.8
                                                                                   	I	:;,:	:	:;;: ••	,	;	:;:;;:
                      The Agency recommends that 668 ppb be considered as a highly conservative estimate for
               acute surface drinking water levels of THPI. Average chronic levels for 90 and 365 days are 34.1
               and 10.8 ppb, respectively.
                            ^
                           :"1 i' liBliiii "iiiiiiup ,
                                                               ,'; ....... t U'ii
                                                               "li t '" j'5 /
                                                                           ,.      ,
                                                                         ^
                       Tier 2 surface water modeling used the following data for input into the PRZM-EXAMS
               modeling. The following shows the scenarios used:
  niiii,,! I lir'y1"11,,',,*!* 11
                                     Parameter
                               ........ 'v°a'lue .................................................
                                   200 L/g
      Aerobic soil half-life            1.25 days
      Anaerobic soil half-life          1.85 days
      Photolysis half-life (pH 7) 0.42 days
      Hydrolysis (pH 5, 7 and 9)0.8, 0.25,"6:666 days
      Water Solubility                3.3 mg/L
      Vapor Pressure                 8.0 E-8 Ton-
      Henry's Law Constant           9.59 E-10 Atm. M'Mol'1
     	tw-lt " ".?.,
 UlK!	I'Tllilili	II,, ir.ll ,
  ':  iiwiii:'1 ,,,':" i1"1 "," '."'
 'I	H	:!	I'll	pi ,,"'i'
 iiillllliJ	I'W	'	Ill	'  	„
 IPlli	Illlift 	:' '"""!
"'
1
i
IIP
ill
,,11
T
PRZMrEXAMS Modeling Input Scenarios
;; •;"';" iiiii.Crop
Almonds
Apple
Peaches
Prunes
Cherries
Blueberries
•:"'
Location
Los Angeles, CA
Columbia, NY
Spartanburg, SC
Los Angeles, CA
San Joaquin, CA
Van Burn, MI
Weather
(MLRA)
C-20
R-144B
P-136
C-20
C-17
L-97
SoU
Rincon Silty clay loam
Lehigh Silt loam
Cecil Sandy loam
Rincon Silty clay loam
Chino Silt loam
Rimer Loamy sand
Soil Taxonomy
Mollic Haploxeralf
Aquic Hapludalf
Typic Hapludult
Mollic Haploxeralf
Aquic Haploxeroll
Arenic Hapludalf
                 1!	!»«	,,::ai.	'^i
                          i!!!1"!111'1 liUillll 'i1,,,, , :'i',,i il
                                                            46
                                                                                f,'  Ml1
I
    ,i'ni!i!,:iiiiiii;, 'i1'!'!'1 vii,;
                     '	::!,	'I,,1111!,:11!,
it;,'	IF «	i> '',
•I',, iiuiii	•"	n jiii

-------
              3.     Ecological Exposure and Risk Characterization

                    a.     Risk Quotient (RQ) and the Level of Concern (LOC)

       The Levels of Concern are criteria to indicate potential risk to nontarget organisms. The
 criteria indicate whether a chemical, when used as directed, has the potential to cause undesirable
 effects on nontarget organisms. There are two general categories of LOC (acute and chronic) for
 each of the four nontarget fauna! groups and one category (acute) for each of two nontarget floral
 groups. To determine whether an LOC has been exceeded, a risk quotient must be derived and
 compared to the LOC's. A risk quotient is calculated by dividing an appropriate exposure
 estimate, e.g. the estimated environmental concentration, (EEC) by an appropriate toxicity test
 effect level, e.g. the LC50.  Acute effect levels are as follows:

                    -EC25 (terrestrial plants),
                    -EC50 (aquatic plants and invertebrates),
                    -LC50 (fish and birds), and
                    -LD50 (birds and mammals)

       Chronic effect levels are as follows:

              -NOEL (sometimes referred to as the NOEC) for avian and mammal reproduction
              studies, and either
              -The NOEL for chronic aquatic studies, or
              -The Maximum Allowable Toxicant Concentration (MATC), the geometric mean
              of the NOEL  and the LOEL (sometimes referred to as the LOEC) for chronic
              aquatic studies.

       When the risk quotient exceeds the LOC for a particular category, the Agency presumes a
risk of concern to that particular category. Risk presumptions are presented along with the
corresponding LOC's.
                                          47

-------
              Levels of Concern (LOG) and associated Risk Presumption
      111 III
iiiHIIIl'lllllll   I	I" l" in

'111	(	FIMitll'
 iiii I1)	p|i	
 iiii 11 Hi  " mi
"lililllll IIIIIIIH lllliill
nc 	 : 	 : 	 ' 	 ' 	 : 	 : 	 : 	 :' 	 	 .'"v1":1:"1
THEN the Agency presumes...
Mammals and Birds
mi
The acute RQ > LOG of 0.5,

The acute RQ >LOC of 0.2,
The acute RQ > LOG of 0.1,
The chronic RQ > LOG of 1
High acute risk
Risk that may be mitigated through restricted use
Acute effects may occur in Endangered species
Chronic risk and
Chronic effects may occur in Endangered species
Fish and Aquatic Invertebrates
The acute RQ > LOG of 0.5
The acute RQ > LOG of 0.1
The acute RQ >LOC of 0.05
The chronic RQ > LOG of 1
High acute risk
Risk that may be mitigated through restricted use
Acute effects may occur in Endangered species
Chronic risk and
Chronic effects may occur in Endangered species
Plants
TheRQ>LOCofl
TheRQ>LOCofl
High risk
Endangered plants may be affected
              No separate criteria exist for restricted use or chronic effects for plants.
                                   b.     Exposure and Risk to Nontarget Terrestrial Animals
                                   'III''1' ;,ii i'H it'"/ "i'1"'1'! •" ",'i, .iiiiilll .'|i, ' I!' N ""lldillll,1"
                       " 'Him:	i lit;: I'm
                       '"	liiiw ••	,'1	I
                                                 Birds
             iii..
             ill	i
      piiLi	mm;i	r,	w&wMi	i;	&	R	M	w,	WA	;&*i$	w	«	L	.ma-.a	row	^MI	,i>i	s^y	it	ar	;i:-i|
        Residues found on dietary food items following captan application are compared to LC50
 11	'	M:	I	I	I!1	• llllil1 *a	'	f	>"	i	-/	.•	..-	'.	• •	•	s	«	jr-	j"«s-Ł«	x	- •	'	J	s	•,*•	4	•""	• •"'	
 Values to predict hazard. The maximum concentrations of residues of captan which may be

 expected to occur on selected avian or mammalian dietary food items following both single and

 multiple foliar application rates are provided in the tables below.  Residues per Ib ai applied for'

^the	four.foodllltypeFare'Seveiop'eS' from Hoerger and" Kenaga (1972) an3 Kenaga (19*73), with
              modifications suggested by Fletcher et. al. (1994); the "broadleaf plants" category includes forage

              and is considered applicable to small insects while the "fruits" category includes seeds and is

             	considered applicable to large insects'". 	
             ijiiiii       i                     n     	    	  i	      	ii	i	

                     There are no definitive risk quotients for avian acute risk since definitive LC50s are not

              available (3 deaths occurred at 5200 ppm in the bobwhite quail study --MRID 43869802, but no

              mortality was reported at 4640 ppm in MRID 00104686). The following terrestrial exposure
              table for a single application shows that no
II!11!	I""11!!!!	   ,",!'	i	,i ' i  lit  1	i   	i  >	  -,
                                                       acute avian LOCs are exceeded for any use pattern.
                                                                (I	in' ill i
                                                                    'ml
ill
ill III
                                                          48

-------
Terrestrial EECs - Single Application*
1~ Use Site „ ' - \'
Almonds
Apples
Peaches
Nectarines Turf
Pears
Plums/fresh prunes
Strawberries
Apricots
Blueberries
Cherries
Grapes
Applic. rate
4.5
4
3
2.5
2
' Food item :.* „-
short grass
long grass
broadleaf plants/ insects
seeds
short grass
long grass
broadleaf plants/ insects
seeds
short grass
long grass
broadleaf plants/ insects
fruits/seeds
short grass
long grass
broadleaf plants/ bisects
fruits/seeds
short grass
long grass
broadleaf plants/ insects
fruits/seeds
maxEEC(ppm)
1,260
578
709
79
960
440
540
60
720
330
405
45
600
275
338
38
480
220
270
30
       Maximum residues from a single application are below the no-mortality levels for all
species tested and are thus unlikely to result in avian mortality from dietary exposure.

       For multiple applications, a terrestrial exposure model called FATE is used to estimate
residues based on accumulation from repeat applications at a given interval and degradation rate
due to estimated foliar dissipation. Since actual foliar half-life data are not available, the
dissipation half-life (9 days) was estimated, based partly on dislodgeable residue information
available to the Agency. Where maximum residue values are used, captan concentrations are
expressed as EEC maximum (max) and average maximum (avg. max.).  When mean values are
used captan concentrations are expressed as EEC average mean.
                                           49

-------
                                                                                                                              nil Hill 111 in inn nil   iiiiiiiiiilliiiiii iiiiiiiiiiiiiii in iiiliiiiiiiiiiiiiii mi iii|iiniliiiiiiii  i,  I  iiiiiinii iiiiiiiiiini nil in mi     I in inn in   n  inn mini in mi


                                                                                                                                                                                      II
     i	nrn	ii'iii,  ''Tiin .it |.  ...it* .mi ,.i,n, i
	||	
!:«^^^^
MEMF"	it!"
HMffvlil* ,im*
	 Ih'l" In, I
<   ;i	ill, 1

i	;-j'ii;iv
 I|||I	I	»"	!	I" iir

  :.,;	 •;	; .;:;i;;;;;l;	t1:11 '
  I	•    ill!,    i: LI1*;!1
 ,MI: I' iiiii>!'I*
Ter
niiH "iiiiinn:
1 11. ill

m"::':
III i."'1:"
'!'; ; tl
•L:..'
nfl 	 '
III
K1"

±i r!;,::,,,!,,,!!1
iii:!!" i" !;iis
:=,:' '"

•', »« Hi1"
iiiii:.;'!
n"! , ;.iifi'
liill','1 !'!,
II:
restrial EECs - Multiple Ap
Use Site
Almonds
Turf-
Apples
Peaches
Nectarines

Pears
prunes
Strawberries
Apricots
Blueberries

App. rate
(Ibs ai/A)
4.5
4
4
4
3
3
2.5
No. of
apps.
5
8
7
8
9
7
14
plications*
Applic.
interval
(days)
5
7
7
3
7
7
7
Food item :
short grass
long grass
broadleaf
plants/insects
seeds
short grass
long grass
broadleaf
plants/insects
seeds
short grass
long grass
broadleaf
plants/insects
seeds
short grass
long grass
broadleaf
plants/insects
seeds
short grass
long grass
broadleaf
plants/insects
fruits/seeds
short grass
long grass
broadleaf
plants/insects
fruits/seeds
short grass
long grass
broadleaf plants
fruits/seeds
. EEC,,
(ppro)
max.
3,368
1,545
1,895
211
2,272

1278
142
2,250
1,161
1266
159
3,921
1,797
2205
245
1714
786
964
107
1688

949
105
1439
660
811
91
EEC
(ppm)
; avg.
max.
2168

1220

1572

859
95
1485

835

2589
1187
1456

1170

658

1113

626
70
1038

585

EEC
(ppm)
max.
mean
1192

630





797

422

1388
588
735

607

321

598

316

510

271

EEC
(ppm)
avg.
mean
767

406

N/A
N/A
N/A
N/A
526

278

917
388
486

415

220

394

208

368

196

                                                                                                                                50


-------
JJseSite
Cherries
Grapes
App. rate
(Ibsai/A)
2
No. of
apps. ;
7
Applic.
interval
^ (days) „
3
'i
Food item -
-'V,.
short grass
long grass
broadleaf
plants/insects
flouts/ seeds
EEC
(ppm)
'•max.-
1,865
855
1,049
117
. EEC
(ppm)
avg. ->,
max.*
1219

686

EEC ,
(ppm)
max. \
mean
660

350

1EC4J
(pprn)*
avg.
mean r
432

229

       Each of the above crop groupings has a similar use pattern. The number of applications (based on
       maximum seasonal rates) and application intervals for underlined crops are considered representative.
       Foliar half-life used is 9 days.

       For the sites evaluated, estimated maximum residues resulting from multiple applications
at the maximum rates and minimum intervals are below the no-mortality level in all avian LC50
tests. Thus, it appears unlikely that these dietary residues would result in avian mortality.

       Avian reproduction testing was conducted at up to 1000 ppm, with no effects reported.
An evaluation of all foliar uses at the maximum label rates; multiple applications and minimum
intervals would potentially result in maximum residues greater than 1000 ppm on most avian food
items. However, without data for higher concentrations, the Agency cannot determine if higher
residues could cause adverse reproductive effects. A refinement of the exposure assumptions for
orchards suggests lower residues and therefore less likelihood for chronic risk.  The refined
exposure assessment is based on the following assumptions:

       1) Maximum residues were outliers resulting from a direct application. Note that in the
       case of short grass the maximum (240 ppm) vs. the mean value (85 ppm) differ by 3X.

       2) To be consistent with the assumption in aquatic exposure models for aerial or mist
       blowers, only a portion (<100%) of the application rate is assumed to hit or be retained hi
       the target area at the time of or shortly after application.

       3) The duration of a bird's exposure to the specific dose level should be considered.

       Assuming a direct application of 100% of the applied rate reaches the orchard floor to
contarninate short grass (as contrasted with a bare floor, long grass or even an intermediate
substrate such as broadleaf vegetation) these average residues for short grass in almond orchards
could range from 767 to 2168 ppm (based on mean and maximum values respectively). Given the
previously mentioned assumptions for orchard uses, chronic risks to both birds and small ground-
dwelling mammals will be based on average mean values unless stated otherwise. Since none  of
the average mean values exceed the NOEL of 1000 ppm, there does not appear to a chronic risk
to birds from captan's use in orchards.
                                           51

-------
                            .............. Jill
                                    i. 55" ::w '"i" liiif'ii Jiiiiii I at; ' t ...... t • * . •' I'
                                                                                     	!-
                                                                                       II
                       Captan's use on crops such as strawberries and turf results in a direct application to avian
               food items; consequently the average maximum value was compared to the NOEL for a
               preliminary chronic risk assessment resulting in risk quotients are between 1 and 2.2.  Repeating
               the avian reproduction study would reduce the uncertainty, but the value added would be low. In
               the case of turf, residues could be reduced as result of increased biomass as the grass grows and
               the subsequent cutting and potential removal of clippings (especially on the intensively cared-for
               turf— greens, tees and lawns).  Strawberries grown commercially (where direct application of
               captan use is likely to occur) will have little if any competing vegetation — especially if the
               strawberries aye grown using plastic mulches, since captan residues are below1006 ppm for
              JIIIFiMSects, fruit and the strawberry plants, no chronic risk is anticipated.
                                                •.'*•*	fc'Bfe*	'
                                            ,(2)     Mammals
                                                                                       I

                                                                                     /alt
     li!i> ""iiii 'H" in
   "j^l1!1^	IB

jiiiiir       	i*
       Small mammal exposure is addressed using the acute oral LD50 values converted to
estimate a LC50 value for dietary exposure. The estimated LC50 uses the following formula:
                                                                        I
                              LC50 = LD?0 x body weight Cg^
                       :•::	,™ r;i:, •	;,.;,,•;• food cons. VQT dav (e)
   i	ll	Jill!	i	.Jill	i	.M!	if	!	1	l&	i	i	Ml	I!	ii;	P&'Mftii	«	•	i	«	,-,:
                                                                             -F.I ...... ..... rii fw.c ..... , ............. .•;• ........ .......... • ....... i .......... •'".
                                                                                 i
      " ii^ "u ..... i,;;:!;! ir, mi ..... iiiiiii, • ! iiiiu^ ' isii1:.,,; .a ;. ...... HI,:" ft a «ira t ' ....... maita ..... i; i- i :i< T ....... >', i " i sxtmnat ..... iiL'iiiiiiiii* ijŁia^^^^  :JBK^^^^^^^^^^ ..... ihi: ...... CHI ........ t'liii1 ;:! ...... •:• ..... k • m ^v
       SB^SSviffi Small Mammal Food Consumption in PPMs (Based on an LD«, = 9 gm/kg)
       ' invillEll' < ! i!,,i: ...... - ........................... • [[[ " ....................... • ....................... • ............................. '-' ..................... Miini^ ...................................... ni ............................................... r _ i _ 2XŁ _ S. _ ZSZ
                                                                                                      - ....... , ...... , ........... « ........... .. ..... .............. ..................... • ........................ ,, ........ t ......... I
Small Mammal
Meadow Vole
Adult Field Mouse
Least Shrew
Body Weight
fem)
46gms
13 gms
5gms
% Weight
Eaten/Day
61%
16%
110%
Food/Day (gm)
;. - ,., - ,.;.:.'• ^ ;•. :. :_,;..
28.1 gms
2.1 gms
5.5 gms
EstXQo/Day;;;';
(ppm) :.:':'y
14733 ppm
557 14 ppm
8181 ppm
      '	IB,;
    jftii1:	i«i
        The above table is based on information contained in Principles of Mammology by D. E. Davis and F. Golly,
       liiill11 MI, L "Ui jjfiiih!*	iiiiwiiiii	iiillinillllliliiiLi, :n|.:illlll,ll,iilllllllli|i .'hWlillll:;1'!!! lin	Ill, HI	if	i,liililllllllllT!lllllK'	ini1 IL illl1,*;, ,'ti »'!llll'!|!"ili!1'ii: 'lli'»* H	'iiirmiriiiij,,	ii	" •iiiii'iiiiiiii l^iimii	ii	/	,	,,	 ,',:	liiiinij" 111,1iu",,!!iin v,	ir.	„• ,ii '»	•"	•	i; 	i, 'i  » if,
       I'jpubhshed by Reinhpld Corporation, 1963.
                      The estimated LC50 is then compared to the residues listed above to calculate a risk
              II It jljy {>, jlllilL |	I HI	IIIIIM^^^^^^^^      illlllilll	'iliilti, ->U		,	T. •,	,	 :,	'  	1  II	-	,	'	,	, I,	,.,	!• 	'		 		
               Quotient (EEC/LCjso). The estimated LC50 in these calculations can be considered as the
                              Itoxicant in a day's diet, lethal to 50% of a test population.
                            ',	Illlllf 'Jii!IW^^^^^^^     	I «•	>;.>I! J J'' ti '"<, ":/":, 'iiiL,	I	JIF K	I;
                                                                            "} 'liEiililiit'	»«i9^	4l!l
                                                                                                    iiii,. it,ii  '.ij	i	',[";
                                                                                                                   	   I
                             apjpfica'dons of captan to almonds, apples, peaches, nectarines, turf, plums/fresh
               prunes, strawberries, apricots, blueberries, cherries and grapes with single application rates
  r : 'iihii i	:	r ilium
IlllliJi:1!:,!);!	t''r",.l\"  1 i«
lliilllii" ililiilliri'i: TDII!  < !.
'"Hinii iiiBiriiiiiin!	aural •
                  om 2 - 4.5 Ibs a.i/A result in risk ^quotients (RQ) less^ than 0.1 . The exposure estimates
        use3 for terrestrial risk assessment are based on the work of Hoerger and Kenaga (1972) as
       illillii'l |i~ ::i|,|"iii|"|!i: ; , ''''lii'iiiiiiiii.i'r'tiii^iiiiiiHiiii1 ''jiiiiiiiiiiiiiiiiiiiiiiiiiiini iiiiiiiiiiiiiir '"luiiihiiiiiiiiiiiiriiHiuifiiiMiiiiiiiiiii:1 niiiiiiiiMjiiiii:, ..... nininii niniiiiiiniE ..... M;i riiiinv1 < ILIH, :"" iiiiinii!1'!!1 '"OLiiiii; nji,;, v ...... « ,,ri| :,in ..... iiiiiiiiiii^'iai''*,,/!!11 > uLuiiiiiiiiiiiii! ...... : , ............. llln »,«„ ........... •, ................ , , ......... wm, ..... ..... m ,
-------
 extracted from mammalian reproduction and developmental studies. The following table indicates
 that the acute restricted and endangered species LOCs are exceeded for almonds and peaches, and
 that the acute endangered species LOG is exceeded for all other sites. Chronic risk to small
 mammals is predicted to occur for all foliar uses when residues are based on maximum estimated
 exposure values.
Quotients — Multiple Ap
Use Site ' '
Turf
Almonds
Apples
Peaches
Nectarines
Pears
Plums/flesh prunes

Strawberries
Apricots
Blueberries
Cherries
Grapes
App. rate
4
4.5
4
4
3
3
2.5
2
plications, Maximum EEC*
# Apps. *"
8
5
7
8
9
7
14
7
„ *•
App. mterval5{days) -
7
5
7
3
7
7
7
3

1 ?
Small mammal
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
. least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
Acute RQ
0.15
<0.1
0.16
0.23
<0.1
0.23
0.17
<0.1
0.17
0.27
<0.1
0.27
0.12
<0.1
0.12
0.11
<0.1
0.11
0.1
<0.1
0.1
0.13
<0.1
0.13
Chronic RQ
1.14-9.1
0.07-0.6
0.64-5.1
1.7-13.5
0.11-0.84
0.95-7.6
1.3-10.1
0.1-0.64
0.71-5.7
2.0-15.7
0.12-9.8
1.1-8.8
0.9-6.9
0.05-0.43
0.5-3.9
o;s-6.8
0.5-3.8
0.1-0.6
0.7-5.8
0.1-0.36
0.4-3.2
0.9-7.5
0.1-0.47
0.5-4.2
.bach ot the above crop groupings has a similar use pattern. The number of applications (based on maximum seasonal rates) and application intervals
for underlined crops are considered representative. Foliar half-life used is 9 days. The current standardized models are as follows: -meadow vole
consuming short grass; -adult field mouse consuming seeds; -least shrew consuming forage and small insects

        Multiple application risk quotients have been calculated based on the following
assumptions:
                                                53

-------
                                      ii'i l/liillf WM "'i!!•	!'!	IIP:" I ° i,,' i.' i JIiuE JIllUi'Hfll 'iJ' I'"'' 'iVflPi • IA. •!:•'	', !i:>,l"i:,'»W'luii I III  II  IIP III II
                                                                                                  II  III11 IIP III III I 111 III I III I

                      1. The turf use is a direct application to food of the following: short grass for the
                                   meadow vole) and the insects for the insectiyore (the shrew) and the seeds
                      of the granivore (field mouse). Acute risk will be based on maximum Fletcher residues and
                      chronic risk will be compared to the average maximum Fletcher residue values.
                             [[[ * .........................................  °                          •             . •
                                                                                                   eaters
         :''4:«''	!	^^4. ^a neroiypres^ (see above). Acute and ichronic risk is,,based on |the same principle as turf

                     3, Most other crops are orchard crops with indirect application to non-target plant
                          iaJ,  Cover on orchard floors could vary from bare ground to short grass, long grass
                         S^ilg^g!??*8: ........ •^,,Md^?!°ŁyiiWouldi5olihes^^
                                         e
                                                                                    fidd mouse
                                        seeds and insects on tre floor that have not been sprayed directly.
             :Mammal	Risk	Quotients*
   ^     ' '
    ^     ..... i1! ....... Iiiiiiii!
  iRiW     N iiiihi! !,«l:
1111!	lllilli HP	   (
	 	 	 	 : 	 - 	 Use Site 	 	 1 	

Turf


Almonds


Apples


	 Peaches


Penis
Plimis/ftesh pnines


Strawberries


Apricots
Blueberries

App. rate

4


4.5


4


4


3


3


2.5

#Apps.

8


5


7


8


9

•
7


14

App. interval (days)

7


5


7


3


7


7


7

Small mammal
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
meadow vole
field mouse
least shrew
Acute ROV
0.17**
<0.1
0.17**
<0.1
<0.1
<0.1
<0.1
<0.1
<0.1
<0.1
<0.1
<0.1
<0.1
<0.1
<0.1
0.11**
<0.1
0.11**
<0.1
<0.1
<0.1
Chronic RQ'::
0.8-6.3***
<0.3
0.4-3.4***
<0.3-1.6
<0.3
<0 .3-1.6
<0.3-1.1
<0.3
<03-1.1
<0.3-1.9
<0.3
<0.3-1.9
<0.3-0.9
<0.3
O.3-0.9
0.5-4.4***
<0.3
0.3-2.5***
<0.3-0.8
<0.3
<0.3-0.8
                                                          54
ill 11 in   II
iiiiiiH	:	.1   it	;	i
 11
i"	

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      Use Site
App. rate
                            SApps.
App. interval (dayjX
Small mammal
                                                    Acute RQ
                                                                                   Chronic RQ
                                                       meadow vole
                                                                                    <0.3-0.9
      Cherries
       Grapes
                                     field mouse
                                                                  <0.3
                                                        least shrew
                                                        IWUOL oiuk/w         ^*u.l         ^«U.i3~U.7
 Note: number of applications (based on maximum seasonal rates) and application intervals for underlined crops are representative of crop groupings
 Estimated foliar "half-life" used is 9 days. The current standardized models are as follows: -meadow vole consuming short grass; -adult field mouse
 consuming seeds; -least shrew consuming forage and small insects. Broadleaf plants value is used to calculate meadow vole risk quotients in orchard
 crops.
 * Multiple Applications: Mean maximum EEC for acute risk (except as noted); Average Mean EEC for chronic risk(except as noted)
 ** Maximum Fletcher residue value
 *** Average maximum Fletcher residue value

       With multiple applications, the acute endangered species LOG is exceeded for turf use, as
 is the chronic risk for herbivores and insectivores. The magnitude of this risk may be small if this
 use is for spot treatment on sod farms, golf greens, or even home lawns. Strawberries potentially
 exceed endangered species concern for small insectivores and herbivores. No other sites exceed
 any of the acute LOCs. The multiple applications of uses of captan for almonds, apples and
 peaches exceed the chronic LOG for herbivores by slightly over 1.0. The actual risk could be
 lower as the residues (even though they were the average mean value over the application period)
 were based on the understory being directly sprayed. The indirect spray values are likely less than
 those predicted for a direct spray. Consequently, the chronic risk would be further reduced. The
 acute and chronic risk from captan's use on strawberries is uncertain depending upon the use of
 maximum (some risk) or mean Fletcher residue values (minimal risk).

                             (3)    Terrestrial Insects

       Ecological toxicity data on honey bees indicate that captan does not appear to pose a risk
 to insects. No further risk assessment will be conducted.

                             (4)    Nontarget Aquatic Animals

 Expected Aquatic Concentrations: The Agency uses the GENeric Expected Environmental
 Concentration program (GENEEC) to calculate screening level EECs in water based on drift and
 runoff from a 10 hectare field to a 1 hectare x 2 meter deep water body. These EEC's take into
 account degradation in the field prior to a rain event as well as degradation and partitioning in the
 pond. Since the Agency does not have a refined exposure scenario for turf, the GENEEC
 program was used. GENEEC was also used to estimate the exposure from typical use  rates  for
 the following sites: almonds, apples, peaches, prunes, and cherries.

       A refined EEC is included for those use sites that the Agency modeled using the Pesticide
Root Zone Model  (PRZM2) to simulate pesticide movement off site via drift and field runoff, and
the Exposure Analysis Modeling System (EXAMS II) to simulate pesticide fate and transport in
an aquatic environment (one hectare x 2 meter deep).
                                             55

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                 Estimated Environmental Concentrations (EECs) for Captan*
    mill  ill1 in
111 1 II lllllllllllllllllllll 1
Crop
• h j |
m 1 I
Turf
Almonds
Apples
Patches
Prunes
Cherries
Blaeberries
Application
Method
foliar
spray blast
spray blast
spray blast
spray blast
spray blast
spray blast
Application
RateinIbsa.i./A
(No. of applies.)
4.0(8)
4.5(5)
4.0(8)
4.0 (8)
3.0(9)
2.0(7)
2.5(14)
Initial
EEC
(ppb)
43.4
91.7
49.6
104.8
57.9
6.9
36.8
4-day
EEC
(ppb)
11.6
19.8
10.6
19.5
13.1
2.0
6.7
21-day
EEC
(ppb)
2.2
5.5
3.3
6.9
3.8
1.1
1.7
60-day
EEC, ,
(ppb)
0.8**
3.3
2.9
6.0
3.5
0.97
1.6
90-day
EEC
(ppb)

2.6
2.0
4.0
2.6
0.65
1.5
	i	,•	,	,	T	-,;	.,,,1-	SSfi^teijUBsfcess
;	,	,	,	;; ..  ., , „ ; , „ ;; *'tVCragC 56-^ EEC
                              except turfc from Agency review using PKZM2 (version 2.3) and EXAMS II. Turf EECs from GENEEC model.
                                                                                              II
                                                 "(5)     Freshwater Fish
^^
 ill lli'l .......... llll
      i ...... Jlirfil"
                             : acute and chronic risk quotients are reported below:
                             in              i
                                Quotients (RQ) for Freshwater Fish
•fjrjf
' : ::!
* 	 i,;,1"!,!,;;*1"!!:


	 1 	 hi 1

mm,
Crop/appl. rate (Ib ai/A)/# of appls.
Turf(4.0)/8
Almonds (4.5)/ 5
Apples (4.0)/ 8
Peaches (4.0)/ 8
Prunes (3.0)/ 9
Cherries (2.0)/ 7
Blueberries (2.5)7 14
Acute RQ
1.6
3.5
1.9
4.0
2.2
0.3
1.4
Chronic RQ ;
0.03
0.10
0.08
0.16
0.10
0.03
0.05
                         Acute RQ = initial EEC/LC50 (LC50 for brown trout, most sensitive species, = 26.2 ppb); Chronic RQ =
                         PCMipy EEC*/geometric mean offish full life-cycle NOEL and LOEL (= 25.5 ppb, fathead minnow)
                :;!,	-:	;::	:::; *M:day EEC for turf (GENEEC model)
                                   Mi'iinn1,:"'!!  jsinriiii',,	i:"" li^iiiuiiiiiiiii in,hi 'iii!1'ii 	H,,:;"!!'!!,!	PMiii'!1:1!",!''11 L,;;1;,„i,11	n,  riii'ii	',,,1	ic jiniLiiii,' 'iiiiniiiLii''	„-! ', s	ii'TCiniillu''!!!^ 'i:1!;1 Biiii'.'.'iiiiiiijliiini,,!''	1'w i'i: 	a 'n'	iiiii''iiii,in' inn n
            'Mil'ii " iiiiiiljh,i,,!i\ii,,i,;iiil<<' in f,:!:!,1', J1 "	i u	,	r i	, «' 	„	',	i1 U" >' ' ' ,<,' in,<,<	
-------
        Chronic risk to fish is not expected based on the MATC (geometric mean of the NOEL
 and LOEL) derived from fathead minnow fish full life when compared to the EEC averaged over
 90 days. A lower MATC can be estimated for the most sensitive fish, brown trout, by dividing an
 application factor of 5.3 into 26.2 ppb (the brown trout 96 hour LC50). The middle value was
 selected simply to strike a balance between the other values. Utilizing the application of 5.3
 results in a MATC of 4.8 ppb for the brown trout  Since this value is not exceeded by the highest
 90 day EEC (3.0 ppb) there does not appear to be a chronic risk to fish.

                           (6)    Freshwater Invertebrates

        The acute and chronic risk quotients are reported below:

       Risk Quotients (RQ) for Freshwater Invertebrates
"Crop/application rate (Ib
ai/A)
Turf (4.0)
Almonds (4.5)
Apples (4.0)
Peaches (4.0)
Prunes (3.0)
Cherries (2.0)
Blueberries (2.5)
•• Acute RQ
0.03
0.08
0.04
0.08
0.04
0.01
0.03
Chronic RQ~
<002
<002
<0.02
<0.02
<0.02
<0.02
<0.02
       lowest LC50 for D. magna = 1300 ppb; acute RQ = initial EEC/LC50; chronic NOEL < 560 ppb.

        The endangered species acute LOG is exceeded for the following modeled sites: turf,
almonds, and peaches. There does not appear to be a chronic risk to aquatic invertebrates for any
use. It is not likely that the daphnia chronic NOEL would be lower than the highest 21 day EEC,
much less the next highest 21 day EEC of 6.9 ppb for peaches.

                           (7)     Estuarine and Marine Animals

       In order to assess the risk to estuarine organisms from the turf use the Agency requires a
96-hour LC50 study for an estuarine fish, shrimp, and a 48-hour embryo larvae study OR a 96-
hour shell deposition study with oysters. The registrant recently submitted a 96-hour LC50 study
with the sheepshead minnow and a static toxicity study with the saltwater mysid, and must submit
a 96-hour shell deposition study.

                    c.      Ecological Risk Due to Seed Treatments

       Foliar treatments of captan would generally be expected to pose a  greater risk to aquatic
life because of repeat applications, runoff, and drift. Also, foliar treatments are not soil-

                                          57

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                                                                                 II  II                    I
              incorporated whereas seed treatments would be to varying degrees. The Agency does not
              currently have the capacity to estimate runoff resulting from seed treatments.

                     In general, seed treatments Have the potential to pose risks to birds since seeds could be
              attractive as a food item.  In the case of captan, however, the chemical is generally in the
              practically nontoxic category for birds, implying low risk.  The highest exposure, and thus risk,
              would appear to be with grass seed. That use is at the highest labeled application rate (9 oz.
i in	i^^filfe^^sSSirP:, ^E*?? !s ^I°^—l>.—°IS,?sŁd to_ kŁ!nl, ,2,™??!!?. •^H?'2W,?;, ™ ,$„ *?, ?PPl!^ 1°
              lightly cover the seeds, allowing for germination. This rate translates into approximately 5625
              pprn on the seeds. If a bird's diet were composed entirely of treated seeds, the residues would be
              slightly higher than the highest test level in most dietary studies, where no mortality was seen.
              Since a bird's diet does not consist entirely of seeds, there is expected to be no risk.

                                   d.      Endangered Species

                     The Agency has concerns about the exposure of threatened and endangered  animal and
              fish species to captan. With multiple applications, the acute endangered species LOG has been
              exceeded on turf.  Additionally, LQCs are exceeded for endangered species of freshwater fish for
              all foliar? turf" and spray blast applications including almonds, apples, peaches, prunes, cherries and
              blueberries.  LOCs are exceeded for endangered species of freshwater invertebrates for turf,
              almonds and peaches.
                      liillllllllllllllllllllllllllll',,, .,"lliilill	"Ivl	JIB,'1 :,1,1 III	i  «'!'	INI"!: Jill' ,;!!!!': 4K III! " <	illlllllll	lllil.l'ii'KliJIIlin"'!	*'!' "'Blll'llll'li'li'''^'!!'.'!!!!!!1'!!!!!, I	iJin ,1' ill1,,I'll'1'!1,,,, '!!• I	II :i";«^ilii^llBillllll",!!!	HI.! 	ML , iilil'l'!"" ( I :|iir'„""„!,Till '"IIII, :  jiiM:!11!!'!!"1 r Jill1 , II milllll'i! "iiinlilllllllllllllllliiiilli1 "TilillliVjillllllllllllL1!
                     The Agency is developing a crop-based program - the Endangered Species Protection
              program to identify all pesticides whose use may cause adverse impacts on endangered and
              threatened species, and to implement mitigation measures that will eliminate the adverse impacts.
              The program would require use restrictions to protect endangered and threatened species at the
^*" |"1'	'_;"" '    '""" cou5gileyel.	p Cp^uj^tio^wi^&e^^Mi ^dJ^dUfe^ervioem^ be necessary to assess risks to
              newly fisted* species Or from proposed new uses. In the gl^e, the Agency plans to publish a
             l^e^csfjptionof the Endangered Species Program in the Federal Register and have available
              f 51untary county-specific bulletins. Because the Agency is taking this approach for protecting
              endangered and threatened species, it is not imposing label modifications at this time through the
              RED. R"atEer, j^y requirements for product use modifications will occur in the fu^e under the
              gndaiigered Species Protection Program.
         "ii »:; 'iiirii' i: it i1 i,; ,>' ",' iiii"" !^jiJMMiii1'' ;!:::i" '•', ? ; > •;: '!*"•" ih,' • i i"'+ i;i; - "'Of'tt,	iiiiK      "»iiriii:' >ji;, ••- if i '&«. • i 11-' ">!  ';. pii	i; TV.  ' i ,•.:,	tf !-j	r alf iiii iw:!:, •IIB I
             	e.	Risk Characterization Summary


              lerreslTial environments. Persistence of the parent in ground or surface water is not expected.
   	,,„ 
-------
 avian species is uncertain because test animals were not dosed at levels sufficient to cause an
 effect. Although risk quotients were therefore not established for avian species, mulitple
 applications of captan at the minimum application interval would potentially result in maximum
 residues greater than the 1000 ppm NOEL for most avian food items.

       A refinement of the exposure assumptions for orchards suggests lower residues and
 therefore less likelihood for chronic risk. The refined exposure assessment is based on the
 following:

       1) Maximum residues were outliers resulting from a direct application. Note that in the
       case of short grass the maximum (240 ppm) vs. the mean value (85 ppm) differ by 3X.

       2) Direct application to avian food items will only occur in the cases of turf, strawberries
       and insects and fruits in the orchard canopy.

       3) To be consistent with the assumption hi aquatic exposure models for aerial or mist
       blowers, only a portion (<100%) of the application rate is assumed to hit or be retained in
       the target area at the time of or shortly after application.

       4) The duration of a bird's exposure to the specific dose level should be considered.

       Assuming a direct application of 100% of the applied rate reaches the orchard floor to
 contaminate short grass (as contrasted with a bare floor, long grass or even an intermediate
 substrate such as broadleaf vegetation) these average residues for short grass in almond orchards
 could range from 767 to 2168 ppm (based on mean and maximum values respectively). Only the
 higher value exceeds the NOEL by 2. Given the previously mentioned assumptions for orchard
 uses, chronic risks to birds will be based on average mean values unless stated otherwise.  Since
 none of the average mean values exceed the NOEL of 1000 ppm there does not appear to a
 chronic risk to birds from captan's use in orchards.

       Captan's use on strawberries and turf results in a direct application to avian food items;
 consequently the average maximum value was compared to the NOEL for a preliminary chronic
risk assessment.  The NOEL (>1000 ppm) is exceeded in some instances; the risk quotients are
between 1 and 2.2. Repeating the avian reproduction study would reduce the uncertainty, but the
value added would be low. In the case of turf, residues could be reduced as result of increased
biomass as Hie grass grows and the subsequent cutting and potential removal of clippings
(especially on the intensively cared-for turf— greens, tees  and lawns). Strawberries grown
commercially (where direct application of captan use is likely to occur) will have little if any
competing vegetation — especially if the strawberries are grown using plastic mulches.  Since
captan residues are below 1000 ppm for insects, fruit and the strawberry plants, no chronic risk is
anticipated.

       Acute risk to mammals is not expected from the use of captan according to label
directions. However, there is chronic risk to mammals predicted for all foliar uses at the

                                           59

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                                                        lit" ..... • !,*
                                                                               ^ ..... l!::an^^      ...... K::I ...... ui^^^          ..... iiiiiilliiB
nil ii
Hlllllhil	
 nniiinji ii in
(I I'll* III
               maximum predicted EECs. Captan was considered non-toxic to the required insect test species,
               the honeybee.

                      Captan is acutely toxic to fish and predicted EEC's exceed levels of concern for acute risk
               to freshwater fish for mostcrops simulated. Chronic risk to fish is not anticipated at any of the
               single or multiple use rates. The EECs used for these assessments are based on the maximum
               application rates and minimum application intervals allowed on the captan label.

                      Typic^l^^^^^u^y^^s^tiianttie maximum label rates. The following tables show
               |Jia| although ttiie resulting EECs are less than those for maximum application rates, acute levels of
               concern for freshwater fish are still exceeded when captan is applied at typical rates.
               Estimated Environmental Concentrations (EECs) for Captan
                      *Mantz report of 1991 (EPA)
                      **Higherthan maximum label rate
Crop
Turf
Almonds
Almonds
Apples
Peaches
Prunes
Cherries
Blueberries
Application
Method
foliar
spray blast
spray blast
spray blast
spray blast
spray blast
spray blast
spray blast
Typical Appl.
No. of applies, x
(rate)


1 x (2.7)
2 x (2.7)
3 x (2.3)
3x1.6
1 x (2.7)
2 x (2.3)**


Initial
EEC (ppb)


27.5
28.1
23.9
16.6
27.5
23.9 '


21-day
EEC
(ppb)


1.4
1.4
1.2
0.9
1.4
1.2
—
56-day
EEC
(ppb)

_
0.5
0.5
0.4
0.3
0.5
0.4


       Briii, "*::, jiiiiiiinpiiiK t	• 'isii! *	iiiiiiiiiiL;!>.iKiK, ..... iSiiSix ...... i ....... ifi'VSdi ..... IliiilB^^^^^^ ...... I ...... iA^SK     ..... id:

-------
Risk Quotients (RQ) for Freshwater Fish
Total seasonal application
rateObai/A)
Turf —
Almonds (3.1)
Apples (8.0)
Peaches (4.3)
Prunes (3.7)
Cherries (5.0)
Blueberries 	
,' - ,- , AcuteRQ ,: *, - '""':"/ ^ \ ',
....
1.0 *
0.8 *
0.6 *
1.0 *
0.8 *
—
  Acute RQ = initial EEC/LC50 (LC50 for brown trout, most sensitive species, = 26.2 ppb)
       * exceeds high acute, restricted use and endangered species LOC's
IV.    RISK MANAGEMENT AND REREGISTRATION DECISION

       A.     Determination of Eligibility

       Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether products containing an active ingredient
are eligible for reregistration. The Agency has previously identified and required the submission
of data to support reregistration of products containing captan.  The Agency has completed its
review of these data. Appendix B identifies the generic data that the Agency reviewed as part of
its determination of reregistration eligibility of captan and lists those studies that the Agency
found acceptable.

       These data were also sufficient to allow the Agency to determine that captan, labeled and
used as specified in this Reregistration Eligibility Decision, can be used without resulting in
unreasonable adverse effects to humans and the environment. The Agency therefore finds that
products registered for these specific uses containing captan as the sole active ingredient are
eligible for reregistration, provided actions are taken as specified in this document.  Actions
needed to reregister particular products are addressed in Section V of this document.

       The Agency made its reregistration eligibility determination based upon the review and
evaluation of the data required for reregistration, the current guidelines for conducting acceptable
studies to generate these data, and published scientific literature. Although the Agency has found
most uses of captan are eligible for reregistration, it should be understood that the Agency may
take appropriate  regulatory action, and/or require the submission of additional data to support the
registration of products containing captan, if new information comes to the Agency's attention or
if the data requirements for registration (or the guidelines for generating such data) change.
                                            61

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I•ll I!	I)'I	i
                              1.      Eligibility Decision

                      Based on the reviews of the generic data for the active ingredient captan, the Agency has
               sufficient information on the ke^g effects of captan and on its potential for causing adverse
               effects in fish, wildlife, and the environment. The Agency has determined that captan products,
               labeled and used as specified in this Reregistration Eligibility Decision, will not pose unreasonable
               risks of adverse effects to humans or the environment. Therefore, the Agency concludes that
               products containing captan are eligible for reregistration, subject to the terms and conditions of
               this RED, except for mosewjthus^
               Products applied to turf at sod farms or golf courses are eligible for reregistration; uses at all
               other turf sites are being voluntarily cancelled.  Wettable powder formulations that are applied
               aerially are eligible for reregistration, provided either: 1) the products are packaged in water
               soluble packaging; or 2) the application rates are reduced to a level that is no higher than 1 .2 Ib
               ai/A.
                2.      Eligible and Ineligible Uses
'2'1 ..... " '/'" | ....... "™ '  'I ..... ™  "  ...................
illinium muni n mi i in i«"_» imn "mi   «««»    '                                                      ll
        The Agency has determined that some uses of captan are eligible for reregistration under
Ihe, conditions specified in this Reregistration Eligibility Decision. The uses of captan on turf,
other than sod farms and golf courses, and the aerial use of the wettable powder formulations
require changes before they may be eligible for reregistration.
                                                                           ii
        B.      Regulatory Position
  •i^1'?'"	;~» '"••' '"• ™vJ^l!'™T_o,lessen_ti3s	risks posed by captan, EPA is requiring the following mitigation measures
               for captan-contaming products:
  |i|'!l,  'PM ,!'"|| !HI!|,||,;,;" ; .i.;; Illllllllll JIIPIK: " "'Ji.'"I1 ''''-llil/i'iiilll11111!	'Illiliiillll1 '" I'"'1:!!1'!!,!1: Vis I!1!11'1'1111!"I1 I'l'IfinK1'', yiP llllll „. ' I:  ''il,,,"": J   ''"'"III, il	 T' jjlli, 'I'I'liflW.,;• , jriS!!; 'll,:"^*!!,;"1!^'11"!!!1^                   'ji'T"','1'!,:,,, ;' '  „!'' HI"1 '  I II   HUH  Illllllll  I II
  	, iiiin               .                  •'' i.'.fffisiiii'.i j^'i	«>& <	iatii4Xiiirtii>i:i'M>aiiti ',.	ii	Kii.(Kii«ii1'iiTS!t\ i	'Hii'titi', •;;:I>":  i ii i HP  iini  ii
  :;!,:::. ~ •  ••.  ±1 r;',„,:„:,, i" ^j.^l]Hlt^..5.^9?l}^,on,,9f.^ t^H8,6,??, o,!!1^,, JtHS,J!°sź,,.§t	s°d f31™3 °J golf
  ::;;:'' ;;•;:,,.;; :=",	"  %?\ •„;;,. tŁ;: -:::	i^rv courses, to	lessen^ the hand^o-mouth ingestion risk to toddlers.
(	~;;;;;	;;;;;;	" ^;;;;;;"^;;;; _;;;	;	;;;;;;;;; _ ;^;_;;;;	;;;  ;;;;_;;;~;	;~ -	;  ' ;	;;	;;;	;	"	v;;	;;;;	!_ ~r;	;;;_;T••;_;;;;;;;	;;	j"~:_	;;;;";:  ~	;	;	;  ;;L  ';;;;;;;" ~  "7"; ^'
                              Various combinations of chemical-resistant gloves, chemical resistant
                              aprons/coveralls, eye protection, water soluble packaging for wettable powders,
                              and dust/mist respirators to lessen the risks to workers
                                                                                         i
                              Labeling changes to lessen risks to nontarget aquatic organisms. Specific label
i	  lang^e"is~providedrn'Sec^^                     	'	

              1'':	'	' p	r	'	The following is	a	summary of the Agency's reg^atory pqsjtkm and rationale for
              mariaging risks associated with the use of captan. Where labeling revisions are imposed, specific
              language is set forth in Section V of this document.

                                                                                         I!     •      ,   .'           '''



igggiil,K      	f '•.,, lin^^ Jfc;U	•'"ICit1" ^.Tir	**>'	'.MT^J	•'»	"1| *,t-t\ tc^- 	,»' i i'"1 "^ .W-M.''^^* It -^ *rt&. f.	>.>•#: ' jlWIf ^ 1JiAI ^m	W V * •'• >&:$"  ^'' '' ' IT1-!*' filiil	'faM'.MS*- " ••
                II I'jHiii'liaillW liillllJ''1 1,1 il1!:, '"KFJIIIIII  MlllllIlllllli|i",;;ii!IT  i	'» 'If i""	'I 	T	MiT	\ J" lIU""  'SIWlH "" TIIIA III1 Q^

ilH	,	iff1' iiif  ' t iJ ms"&:!"»i!!,;,,,;?!*! \ liii •. BE • !•;»,	, f i,,. "li •'	, ij; 1^1'; •;	;•:	i •	\. iffii %  ;M ..«;; s*	i,; 'i • j'»»,!!;«, • • -;„, iiL,;1! : i „;; ,,b:;(, i;;  t':,	,•;,. - • v •»' *!«,	•  i	:•;: :i: • "S!-, >mam • VKi,
              1 IIIHiUlllP'	Ill11' 	:i,:i;,i ,,,' ' ,il	nilUl!! lllllillllllilH  IM	 l< >;« 'I « ,,,'H I'linn,:!,,.1!, >,  V 	 ' „ " « !V .1 .TIIii'lK1"!"!" 'iVIIiy ,i n if ,," s"l";.«i,, ' ..lisJIi''!!	 TV'!,;!''/ili'iiiii il III,, "'"'''>"I" mi*,, A	.i:,l|,l." '',
-------
              1.     Food Quality Protection Act Findings

                     a.     Determination of Safety for U.S. Population

       EPA has determined that the established tolerances for captan, with the amendments and
changes specified in this document, meet the safety standards under the FQPA amendments to
section 408(b)(2)(D) of the FFDCA, that there is a reasonable certainty of no harm for the general
population. In reaching this determination, EPA has considered the available information on the
aggregate exposures (both acute and chronic) from non-occupational sources, food and drinking
water. Section 408(b)(2)(D)(v) of the Food Quality Protection Act requires that, when
considering whether to establish, modify, or revoke a tolerance, the Agency consider "available
information" concerning the cumulative effects of a particular pesticide's residues and "other
substances that have a common mechanism of toxicity." The Agency believes that "available
information" in this context might include not only toxicity, chemistry, and exposure data, but also
scientific policies and methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although the Agency has some
information in its files that may turn out to be helpful in eventually determining whether a
pesticide shares a common mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues concerning common
mechanism of toxicity in a meaningful way.

       EPA has begun a pilot process to study this issue further through the examination of
particular classes of pesticides.  The Agency hopes that the results of this pilot process will
increase the Agency's scientific understanding of this question such that EPA will be able to
develop and apply scientific principles for better determining which chemicals have a common
mechanism of toxicity and evaluating the cumulative effects of such chemicals. The Agency
anticipates, however, that even as its understanding of the science of common mechanisms
increases, decisions on specific classes of chemicals will be heavily dependent on chemical specific
data, much of which may not be available at present.

       At this time, the Agency does not know how to  apply the information in its files
concerning common mechanism issues to most risk assessments; however, there are pesticides for
which the common mechanism issues can be resolved.  For example, pesticides that are
toxicologically dissimilar to existing chemical substances (in which case the Agency can conclude
that it is unlikely that a pesticide shares a common mechanism of activity with other substances)
and pesticides that produce a common toxic metabolite (in which case common mechanism of
activity will be assumed).

       Captan and folpet share a common metabolite, thiophosgene, which is believed to be
responsible for the carcinogenic effects of these compounds. Thiophosgene is a highly reactive,
short-lived species. Studies indicate that thiophosgene causes local irritation of the site with which
it comes in contact, and is believed to cause tumors through the irritation of the duodenum.
Because they are so short-lived, thiophosgene residues cannot be quantified. Without measurable
residues of the common metabolite, it is difficult to relate exposures of captan to those of folpet

                                           63

-------
             since the rate of formation of thiophosgene may be different for both compounds. However,
             assuming that the carcinogenic effects observed in both pesticides are due solely to the metabolite
         ' ,ii' T »\ff\ hiii, ,1 r i|||||||||| 1 1| •lllllllll ill III I IlllllllllHliiillllllhSSi .............................. mi ............ ' ........................ , [[[ iBS .................................... HI ............................... , , i,,.h , , ........................ .............. i' ....................... ....... ' ........... ............... . ................................... , ........................ A [[[ ........................................ a, [[[
         ''^ySntmopnosgene, the Agency believes it is reasonable to add the estimated cancer risks from the
!T	ei"S™BSis	"j individud aggregate risks |rom both folpet and captan to
     J!n i!'"!!!!!!! li,,^ , , .Hl"!1!1^; 4 i
                      .....                                                 Worst case estimate,   or
             3g)tan, the dietary cancer ..... nsestimate foj_tibeiUS population from exposure to residues in/on
         ::= i: irfood is 1.3 x 10"7.  For folpet, the dietary cancer risk estimate for the US population from
         Ł~ :,; rexgosure ..... to ..... residues ..... in/onfood ...... is 9.8 _x_ 1 0'8 n. ......... If these ...... two risks ...... are ...... added together the total risk
                       ............... 2Jjeiiaggregate ..... cancer Drird^g Water Level of Comparison (JOWLOC,^^ ) based
             onjhis total cancer risk estimate is 11 ppb, ushig the captan Qj* of 2.4 x 10"3 .  The estimated
             erivifonrnental concentration (EECs) for folpet are 1 ppb (sw) and less than  1 ppb (gw).  The
             EECs for captan are 4 ppb (sw) and less than 1 ppb (gw). The largest EEC of 4 ppb is less than
             jhg DWLQD, the Agency's level of concern. This aggregate assessment is for dietary exposure
         '^ ||l|ly: ........... The tumor ..... of concern occurs in ..... the ..... GI tract (djaodenun^ejumjm^l        a result of oral
             dosing. Trie relevance of dermal exposure to a GI tract tumor is unknown at this tune.  Thus, the
             Agency Concludes that an aggregate cancer risk estimate considering dietary (food and water)
             exposure only for captan and folpet based on their common metabolite thiophosgene is
         ........... :::"" ' ..... appropriate.

                   In assessing acute aggregate dietary risk, EPA used a NO AEL of 1 0  mg/kg/day from a
             developmental study in rabbits. Because the NO AEL is from a developmental study the sub-
             population of females 13-50 years, is the subgroup of interest. The acute dietary risk assessment
             was a highly refined, and therefore reasonably realistic, probabilistic (Monte Carlo) assessment
             that used anticipated residues and percent crop treated data. EPA estimates that residues of
             captan in diets of females 13 - 50 years accounts for 36% of the acute PAD. This leaves 64% of
                .....          '            .....    .............                          ''  .......    "     .....          .....  ..............................................
             the acute PAD for aggregate risk.  The:
 r:zsi^:'"J;1;":.,4tpproximately 1900 ppb. Because the predicted ground water concentration is only 3.40 ppb and
 ^.^f	Zf ,.	l^^jilllfti^diptedjeak surface water	concentration	is 668 ppb, aggregate acute exposure and risk are
       !|1!|  ,«iji	irp^flj
         •t'ii!fMH!M	iiilThe chronic (non-cancer) aggregate assessment was performed using percent crop treated
             dataj and anticipated residues which considered USDA and FDA pesticide monitoring data and
         'iE i!;;;|E3uction/coj^centration factors. The drinking water assessment used modeling, as above, to
         ^.^ 'predict ground and surface water concentrations of captan. Chronic dietary exposure to the US
             population accounts for less than 1% of the chronic pAlX This "leave's99% "offfiechronic PAD
             for aggregate risk. For the general population, the DWLOC corresponding to 99% of the chronic
             PAD is approximately 4500 ppb, which is far greater than the predicted groundwater
             concentration of 3-4 ppb and the predicted surface water concentration of 10.8 ppb.  Therefore,
             tiie Agency concludes that the aggregate chronic exposure and risk are not of concern.
         	I	y
n	mm	!s	ill!	ij;:;>!^Ł!;iM^^^^^^^^^^^^^^    	IŁ:H^^^^^^^^^^^^^^^  	m,Mm	miK>"?i	
	Determination of Safety for Infants and Children
                                                                                                         11
IIIIH^
                             |I«H^          	!M                                                           	 |
                                                               ^lerancesfor captan, with amendments
S^3=2:' '1'ii :'-';'iil	iliiPgcs as specified in this document, meet the safety standards under the FQPA amendments
:=      	•JSE.te'oaSmn	IM^^vrrV'^Se'F^                                       	ofno'harm'for	'
               se
	llill	!!J!i	ili^^^^^^^^^
                                         	'n*	
                                                                                     ii1!"11 Hi!:1!	mi i-	,t ii
                                                           '"I'lll'lil /SIJ"''!!™'!^^!''!!!!!.'™™!;!!!!!'111'''!!!!!11!	Hi,, ,,<|'<, .'iillPI'T E 1 I,,

-------
 infants and children.  The safety determination for infants and children considers the factors noted
 above for the general population, but also takes into account the possibility of increased dietary
 exposure due to the specific consumption patterns of infants and children, as well as the possibility
 of increased susceptibility to the toxic effects of captan residues in this population subgroup.

        In determining whether or not infants and children are particularly susceptible to toxic
 effects from captan residues, EPA considered the completeness of the database for developmental
 and reproductive effects, the nature of the effects observed, and other information. Based on the
 current data requirements, captan has a complete database for developmental and reproductive
 toxicity. Reliable studies cited earlier in this document demonstrated no increased sensitivity of
 rats, rabbits or hamsters to in utero and or post-natal exposure to captan.  The Agency has
 determined that the Safety Factor can be removed (reduced to IX) based on the developmental
 and reproductive toxicity studies available for captan, as described previously in Section
 III(B)2(a) of this document. Therefore, the Agency has concluded that a total uncertainty factor
 of 100 (10X for interspecies extrapolation, i.e. using animal data for humans, 10X for intraspecies
 variability, i.e. differences in how humans react to a pesticide, and IX for the FQPA safety factor
 for protection of infants and children) is adequate to protect infants and children.

       EPA estimates that the residues of captan in the diets of infants and children, specifically
 the sub-population infants less than 1-year,  account for approximately 1.5% of the chronic PAD.
 As discussed earlier, at this level of contribution from food the drinking water  dietary contribution
 is far below the predicted concentration. Therefore, aggregate chronic exposure and risk to
 infants and children are not of concern.

       The Agency has not yet made a final decision concerning the possible common mechanism
 of toxicity and the potential for cumulative effects of captan and other compounds.  Also, the
 Agency is in the process of formulating guidance for conducting cumulative risk assessment.
 When the guidance is completed, peer reviewed, and finalized, captan will be revisited to assess
 cumulative effects, if warranted.  Therefore, for the purposes of the tolerance reassessments in
 this RED document, EPA has considered the risks of captan only.

       During the early stages of the FQPA implementation process, the Agency recognizes that
 some decisions will be made as if FQPA were fully hi place. These early case-by case decisions
 are not intended to set broad precedent regarding the application of FQPA to other Agency
 regulatory determinations nor are these meant to constrain the Agency as it proceeds with further
 policy development and future rulemaking. Therefore, the Agency may, at a later date, reconsider
 actions or decisions as described in this RED.

                    c.     Endocrine Disrupter Effects

       FQPA requires EPA to develop a screening program to determine whether certain
 substances (including all pesticides and inerts) "may have an effect in humans that is similar to an
 effect produced by a naturally occurring estrogen, or such other endocrine effect..."  EPA has
been working with interested stakeholders, including other government agencies, public interest

                                           65

-------
i 1111! i il ill  11
   groups, industry and research scientists to develop a screening and testing program as well as a
   priority setting scheme to implement this program. The Agency's proposed Endocrine Disrupter
   Screening Program was published in the Federal Register of December 28,1998 (63 FR 71541).
   The Program uses a tiered approach and anticipates issuing a Priority List of chemicals and
   mixtures for Tier 1 screening in the year 2000. As the Agency proceeds to implement this
 in inn mini  ill	^n	ninwuiiiiiiniR i, iiiiniiiniini	l^lllln^lilllll•lllnllllillll3llllllllllllllnlJlllh>llll 1:111	S	^	               c?   J ^         „    r
   program, further testing of captan and end-use products for endocrine effects may be required.

                 2.	Tolerance Reassessment
  II!!'I ,!l	inilD!:': VI"

  I'1',! In1 .JiiP'iiL '' "
          Tolerances for plant and animal commodities currently listed in 40 CFR § 180.103(a) are
   for residues of'captan per se.  This tolerance definition is to be retained for plant commodities;
 !!llMM§ver, the tolerance expression for residues in livestock commodities should be "the combined
 Effsiduos of captan and its metabolite THPI...". Section 180.103 snou|^ i,"e subdivided as follows:
... 2"@J"6eneral -	for ^^commodities, (a2]i General - for animal commodities, (b) Section i 8
         enc^Ex^rnptipr^ - reserve^ (c) Regional Registrations - reserved, and (d) Indirect or
      ivertent Residues - reserved.
  iiinKiiE.	mmm>,'
  IliiiiiiS  innwlii '"
                 iiiiHiv t" i:
                 	Ill 111 I "t Ii, i,»	
  IlilllL • ," Ulili: l: ill"'..
              ll'r!,iiiiiiin                 iii	iiLi's	iiiii	ii"'.}	;.l;l „:'::,!,	n.itJlKtfi<'1Btv  i   iiil'ii  n  i ii i      i   ill HI     in i in  i in  in
       ..nil,,!,.!!	"	iiiMHintni:;., .iiiiiniiiinin	in;iiii'iniiir,n,i«ii«iignn"Hiiiiiiii:i .in.. pnijiiiiiniiniiiiri iinin: ,,11111111	:,,;ii i,,,, inn, ,i	i, ' 1111,11, niinnnii.: ,,i;.	sun IB	i	,. j, ',111	in1",.:	.'.inniiin,,. i    in n n in     n i     n i  niininin      i iiiii inni niiiini ni
 	|  	iir	,,,,,,	A Federal^ Register Notice was pubhshed on February 5, 1998, proposing to revoke the
;,; ll^llgwjng tolerances: avocados, garlic, leeks, stialkrts, taro, and pimentos. The final revocation
   notice was published in the Federal Register on October 26, 1998, and became effective on
 | ^J^HiSy'25,1999.  Captan is not applied directly on pears, as a foliar spray, but may be applied as
 ^'posfrJiarv'est application. All applications of captan to caneberries (raspberries and blackberries)
   are 24(c) registrations, that is, Special Local Needs (SLNs) in Oregon, Washington, Ohio,
   Pennsylvania, and South Carolina. The reassessed tolerances are presented below.
                                  '! c	1R..II,:.', is:11; mr.fi	' ' : ni	me:
               Tolerance Reassessment Summary for Captan
Ililn 	 Eiifeli,,, Hi, i1!;; 	 ;ill
^
•sir:: 	 i; 	 i 	 !i 	 K'X 	 i 	
iiijiii'iitiii 	 &*Ł&, iii 	 ;;, '•<
mficm 	 '!?';;!
ill! 	 IIIIIIHI! 	 1 	 !!!ti, K;,:!'!!, 	 Ill
iM 	 1'tfiiiPi
••liSi, 	 tIT .itil 	 ,i«i
	 i« 	 i 	 	 iii; 	 egiip
""
'"HIlillllllilM'lllllB liin 111 , iiiii , ' n, "ill1 ill
i illlllllllIPP''':^..!^^^!!!'!!!'''!^'!!!!''!!!"!''.!!!! 	 IILIIinil, IIHII1 Mil:
	 niiiiiii^i^fjiniinifni^iijiiiiiiij^ i; HIIPI 	 "ii
^^ 	 :l
'•lIlllllllillM^^^^^^^^^^^ 	 If, I 	 .'••il'.lllll
	 lllilBE^^^^^^^^^^^^^^ 	 •IE: , liM!" IIIII 	
Commodity
Current
Toleranc
e
(ppm)
Tolerance
Reassessmen
t(ppm)
Comment/Correct Commodity Definition
Tolerances listed under 40 CFR §180.103 (al)
Almonds
Almond hulls
Apples
Apricots
Beans, dry
2
100
25
50
25
0.25
75
25
10
Reassign
Formerly interim tolerance in 40 CFR §180.103 (b); re-
establish permanent; data indicate tolerance can be
lower
Formerly interim tolerance in 40 CFR §180.103 (b); re-
establish permanent; data indicate tolerance can be
lower

Available data indicate tolerance can be lowered
Formerly interim tolerance under 40 CFR §180.103 (b);
Crop Group Tolerance to be established for legume
vegetables
                                                                             ir ::>t\ i1  >, ' , ..... F ' !ii " n : "i, •; ilh ' ,,:i ..... ;' : ;  ," , < •  iii9i'"'< >-< „ 'v,,; , i < ..... " ii i,,,, »i, , n1 :'i • • ||" , « ;m ; i
                                                              < ln'h i.;. T ' .J! :i\'f 9 iiJIIUi "IflSSk < l!l 41 ..... <:il» < illlliiP1' J • ' < ' ?W>!" > HI! Piu'll "' in,, ' jl ' '>v J1!!' Ii JNi1" . '' " I1!! :i: "Jl*' ' ; .>' .,'".',  ' 1 ..... lit •' ,|| 14., ; ; IB ;l''i|!l „, IF HUfl>l '

-------
s ' * *
Commodity
, •- -?>!
Beans, succulent
. Beet, greens
Beet (roots)
Blackberries
Blueberries (huckleberries)
Brassica (cole) Leafy Vegetables
(Seed treatment only)
Broccoli
Brussels sprouts
Bulb Vegetables
(Seed treatment only)
Cabbage
Caneberries
Cantaloupes
Carrots
Cauliflower
Celery
Cereal Grains
(Seed treatment only)
Cereal Grain (Forage, Fodder,
and Straw)
(Seed treatment only)
Cherries
Current
''Toleranc
0
(ppm)
25
100
2
25
25
None
2
2
None
2
None
25
2
2
50
None
None
100
Tolerance
Reassessmen
.t -
,<'*-'-' *<•'*:,' ' >
.Comment/Correct Commodity Definition
Formerly interim tolerance under 40 CFR §180.103 (b);
Crop Group Tolerance to be established for legume
vegetables
Crop Group Tolerance to be established for leaves of
root and tuber vegetables
Crop Group Tolerance to be established for root and
tuber vegetables
Crop Subgroup Tolerance to be established for
caneberries
The available data indicate the tolerance can be
lowered; tolerance of 20 is also compatible with
CODEX
Crop Group Tolerance; represents non-detectable
residues of captan.
Crop Group Tolerance to be established for Brassica
(cole) leafy vegetables
Crop Group Tolerance to be established for Brassica
(cole) leafy vegetables
Crop Group Tolerance; represents non-detectable
residues of captan
Crop Group Tolerance to be established for Brassica
(cole) leafy vegetables
Crop Subgroup Tolerance
Crop Group Tolerance to be established for cucurbit
vegetables
Crop Group Tolerance to be established for root and
tuber vegetables
Crop Group Tolerance to be established for Brassica
(cole) leafy vegetables
Crop Group Tolerance to be established for leafy
vegetables (except Brassica)
Crop Group Tolerance; represents non-detectable
residues of captan
Crop Group Tolerance; represents non-detectable
residues of captan
Available data indicate tolerance can be lowered
67

-------
11 II
ll
III 1
(""
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I'll1
••IIP PIIIIIIIIIPIPIII 	 lip Illlllplplllllllplllp I'll, '111 1 Illlllllll
^^^^^^^^^ B^^^^^^^^^^^^ 'PI 1
iipiiiiinniiiii • i ""ii in iipi'ii iiiiiiiii iiiipiii MI n niiiiii
	
.ZZZZ
lll"l!IF'iil>lll,|i:r'lillilllillilllll! , iJJIIIIL , IIIL ''Hi'1' '"Hi illlllliii 'IIIIIIIII
iniiiiiiiiiiiiiiiiinXiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiriiiiir'uii,,': IIL A"iiiiiiii
i
i
.•gar B, ||||||||||||i|||||| ,; ,•: ||||||, ||i|,; ;,,; ,„,! 	 Hi,,,, , ' i ,i iF'illiiji
i Ili'illlE'Hili' 1 'iilUilh'" 'hi'i''!!!!!!! 'llllLlllillill'Jil
I'll III'"!1"'! II , i'llliiP'"' 'il1,, I. Jllll IP' 'I1 i 'J
illllllllilliiiLillWoiil,"!1,' illllli'iiiili'Hlllllllill,1',"!!! 'SI, "< 1! IIIIIIIII
lin^ : jiiii 	 ijgii
!9H^^^^ ,' 	 ililllli
	 USES'SB!; i!!:11..;!;"
	 i 	 ", 	 	 " 	 i
j^:::^;;; ;;==,• :,;;;:;,::,i;;;
'lilSB^IS^&jl
	 B^^^^^^^^^^^^^^^^^^^^^^^^^^
'^^^^ 	 ' Tlii^il'l
^i5ii§r*:^i
[S5;ip5i,f;i^S5i'"iirnirs!
^i^^^^^^^^^^^^^^^^^^w
Ii»^^
;
""I,: 	
i,
mi
IP hPJ ^ HUM^hl hi 4 ( ^H Pj ton'P « 4 n
fill 	 Ill "ll • - • - • - 11 l||ll fflllll <> III -
Iii'" 1' vi" ' " "'" il''1,,!'1! ''"I 'hi PS " "'I' 	 '"lliiii"11"""" "' '" 1!" ""„ 	 (""' '"
Collards
Corn, sweet (K+ CWHR)
Cottonseed (seed treatment only)
Cucurbit Vegetables
(Seed treatment only)
Cucumbers
Dewberries
Dill, seed (Seed treatment only)
Eggplants
Flax, seed (Seed treatment only)
Flax, straw (Seed treatment
only)
Foliage of Legume Vegetables
(Seed treatment only)
Fruiting Vegetables (except
cucurbits) (Seed treatment only)
Grapes
Grasses (Forage and Hay)
Honeydew melons
Kale
Leafy Vegetables (except
Brassica) (Seed treatment only)
Leaves of Root and Tuber
Vegetables (Seed treatment
only)
Legume Vegetables (succulent or
dried) (Seed treatment only)
Current
Toleranc
e
(ppm)
2
2
2
None
25
25
None
25
None
None
None
None
50
None
25
2
None
None
None
Tolerance
Reassessmen
t(ppm)
Reassign
Reassign
0.05
0.05
Reassign
Reassign
0.05
Reassign
0.05
0.05
0.05
0.05
25
0.05
Reassign
Reassign
0.05
0.05
0.05
Comment/Correct Commodity Definition
Crop Group Tolerance to be established for Brassica
(cole) leafy vegetables
Crop Group Tolerance to be established for cereal
grains
Cotton, seed. Non-detectable residues of captan
Crop Group Tolerance; represents non-detectable
residues of captan
Crop Group Tolerance to be established for cucurbit
vegetables
Crop Subgroup Tolerance to be established for
caneberries
Represents non-detectable residues of captan.
Crop Group Tolerance to be established for fruiting
vegetables (except cucurbit)
Represents non-detectable residues of captan.
Represents non-detectable residues of captan.
Crop Group Tolerance; represents non-detectable
residues of captan
Crop Group Tolerance; represents non-detectable
residues of captan
Available data indicate tolerance can be lowered
Represents non-detectable residues of captan
Crop Group Tolerance to be established for fruiting
vegetables (except cucurbit)
Crop Group Tolerance to be established for Brassica
(cole) leafy vegetables
Crop Group Tolerance; represents non-detectable
residues of captan
Crop Group Tolerance; represents non-detectable
residues of captan
Crop Group Tolerance; represents non-detectable
residues of captan
1,

	 " '' ' '" 	 ' •• 	 	 ;: 	 •• 	 ; 	 " • 	 " ' ' """ 	 	 	 ' ; 	 " 	 	 ' 	 •"• 	 	 	 	 	 "" 	 	 	 ' 	 	 " 	 	 	 ' "" 	 	 	 	 { ' 	 ' 	 '• " 	 ' " ' 	 ' 	 	 	 	 ••' 	 	 	 ": 	 	 	
	
[liiilllllllllii iiiipiiiiiiiii 'iiii'iiElii iliilip1 nil 	 IIPM^ ililirw iiiiiiiii ,; w^ «: 	 piiiiliiiiili H jiilin 	 1; 	 " > "ip.!;*1 ilp"1) 	 mpi: ir I'lpili"!11"": " imp1 i \
'
""'i1' ii1" 	 ip'i'Miiii1?!:" iiiii'iilfi"
	 : 	 68
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iiK 	 s iiv ii ':•! , "' ' iiiiiK iiLii •''• ! wii w^^^^^^^^ 	 Hiiia^^^^^^^^^^^^^ •. ''. ' , 	 i'l'iii 	 i iiiiiiiii it, " 	 i;1.' " '"' /• ;; iiif 	 s ""K ,!< 	 i' '>" n 	 » e''iiiK''iiii'Ti»^^ .' *». "i, :• 	 i •irviiiK 	 aif'.1 ; . -\ J'1^ m 	 i;: m "iiii ; nt , i'iii 	 i' . ,11,' "in 	 is w iK^ m
I 	 ijiip ii,:: liiniii 	 11111":, ,,,i!t: :" 	 • • 	 ii|iiiiiiiiiiijiiii»^^^^^^^^^^^ TiiiiiiiiLi, <: 'Eiii'ii :;>ii 	 : a: , 	 	 	 ' iio1? JIIHI!' ;i 	 ' , 	 11, "ill •: 	 	 ivi 	 iii.;!: ,: ; :. ii:11: 	 141 < i:11:11' 'iii, ini'in'i 	 iiiir-i!: , 	 iiiiU 	 'tiiiiii'i » > i iiiiiiiiiiii 	 iiiau ii,',,;i:7iiiK^^^ .i ,• , •' I-ICMIS ,; .iiiiiii; 	 :v iiiFKi ! 	 .; 	 :• itipii 	 i:: 	 ttiiiniiiii 	 ,, ir'niiiiiiiii; •iiiiiiiiiiii 	 , •iiiiE

i i ' ' ,
1 	 i 	 •'•" 	 • 	 ' 	 •" 	 ' 	 '• 	 "" 	 ' 	 '''! 	
iiiiiiE1 , iinii! 	 » i,i,r,
	 ,hl ,,, 	 , 	 j| 	 	 llln|1 	 ,, 	 , 	 , 	 	 Hl 	 p|1 	 , 	 , 	 , 	 , 	 	 ,„ 	 „ 	 	 I ,,, ,,, 	 	 	 	 ; 	 1|lr
"" ' . '. '. "'

-------
,•• . Commodity ' * ',
•*!o
Lettuce
Mangoes
Muskmelons
Mustard greens
Nectarines
Non-Grass Animal Feeds
(Forage, Fodder, Straw, and
Hay)
(Seed treatment only)
Onions, dry bulb
Onions, green
Okra (Seed treatment only)
Peaches
Peanuts (Seed treatment only)
Peanut hay (Seed treatment only)
Pears (post-harvest only)
Peas, dry
Peas, succulent
Plums (fresh prunes)
Peppers
Potatoes
Pumpkins
Rape, seed (Seed treatment only)
Current
Toleranc
e .
:(ppm)
100
50
25
2
50
None
25
50
None
50
None
None
25
2
2
100
25
25
25
None
, •*
Tolerance
Reassessmen
,t(ppm)
Reassign
Revoke
Reassign
Reassign
25
0.05
Reassign
Reassign
0.05
15
0.05
0.05
25
Reassign
Reassign
10
Reassign
Reassign
Reassign
0.05
x, * &•
* f «rf /
' f Comment/Correct Commodity Definition
- , '"' 1% ' " f
To establish crop group tolerance for leafy vegetables
(except Brassica)
No registered products for this use
Crop Group Tolerance to be established for fruiting
vegetables (except cucurbit)
Crop Group Tolerance to be established for Brassica
(cole) leafy vegetables
Available data indicate tolerance can be lowered
Crop Group Tolerance; represents non-detectable
residues of captan
Crop Group Tolerance to be established for bulb
vegetables
Crop Group Tolerance to be established for bulb
vegetables
Represents non-detectable residues of captan.
Available data indicate tolerance can be lowered;
tolerance of 15 also compatible with CODEX
Represents non-detectable residues of captan.
Represents non-detectable residues of captan.
Represents non-detectable residues of captan.
Crop Group Tol. to be established for legume
vegetables
Crop Group Tol. to be established for legume
vegetables
Available data indicate tolerance can be lowered
Crop Group Tolerance to be established for fruiting
vegetables (except cucurbit)
Formerly interim tolerance established under 40 CFR
§180.103 (b); Crop Group Tolerance to be established
for root and tuber vegetables
To establish crop group tolerance for cucurbit
vegetables
Represents non-detectable residues of captan
69

-------
::E:i!
	 i 	 '• 	 	 	 '. 	 ' 	 ;• 	 ""•""" 	 ' 	 -7
	 t
' "' nil II ' |"" in M 1 n"" ill 1 1
' 	 ' 	
111,11 	 ™ 	 I~I~p, 	 ~7 «-J
M^^^^^^^^ 	 i 	 t
mR 	 Hf'1 	 UViBlLfl
ilinillliilll! 'h.'illllllllillllllliiiilr'ii BiiillE!'! 	 ffl'IF I'll, !|J!
"' ,
jjniijlj 	 	 	 	 I
me, 	 Hi; 	 IIIIIK
	 ! 	

1 fSilllllPllSF^iil!!!!!!!!!!!!!!1'!!!!!:!!!!1"1111?!!!!'1 '"'"I!!!1!11!!!" ui *i!! ,
llllllllllllllllli1'1 liiinium IJI Ml L IT III'*1' i < Mill '
lliB^^^^^^^^^^^^^^^ 	 1 	 1'ft ': ""'111
IllliiniliJIli 11! it, !!':!! 111! 	 11!" A:,, 	 I
llllllU 	 KHIlll," 	 Illlllti , 	 llf
siisvrs'U'^
jEillilllllf1 	 Hill, ; I?,,, IHIE 	 :. 	 I:1!!! ' ill)
-^^=^,-==^ ; 	 -;;;„;;
«.™ 	 ":'::;' 	 ;

	 • 	 '• 	 • 	 	 - 	 • 	 ;
	 1
:—=—,~:^, 	 "::::, :'T
„ , ,„ , I , , •' , ,n
Commodity
i=
Rape, forage
(Seed treatment only)
Raspberries
Root and Tuber Vegetables
(Seed treatment only)
Rutabagas (roots)
Safflower seed
(Seed treatment only)
Sesame seed
(Seed treatment only)
Soybeans, dry
Soybeans, succulent
Spinach
Squash, summer
Squash, winter
Strawberries
Sunflower, seeds
(Seed treatment only)
Sunflower, forage
(Seed treatment only)
Tomatoes
Turnip, greens
Turnips, roots
Watermelons
Current
Toleranc
e
(ppm)
None
25
None
2
None
None
2
2
100
25
25
25
None
None
25
2
2
25
Tolerance
Reassessmen
t (ppm)
0.05
Reassign
0.05
Reassign
0.05
0.05
Reassign
Reassign
Reassign
Reassign
Reassign
20
0.05
0.05
Reassign
Reassign
Reassign
Reassign
. Comment/Correct Commodity Definition • ,
. ' • ' • ' .
Represents non-detectable residues of captan
Crop Subgroup Tol. to be established for caneberries
Crop Group Tolerance; represents non-detectable
residues of captan.
Crop Group Tol. to be est. for root and tuber vegetables
Represents non-detectable residues of captan.
Represents non-detectable residues of captan.
Crop Group Tol. to be est. for legume vegetables
Crop Group Tol. to be est. for legume vegetables
Crop Group Tolerance to be established for leafy
vegetables (except Brassica)
Crop Group Tolerance to be established for fruiting
vegetables (except cucurbit)
Crop Group Tolerance to be established for fruiting
vegetables (except cucurbit)
Available data indicate tolerance can be lowered;
tolerance of 20 is also compatible with CODEX
Represents non-detectable residues of captan.
Represents non-detectable residues of captan.
Crop Group Tolerance to be established for fruiting
vegetable (except cucurbit)
Crop Group Tolerance to be established for leaves of
root and tuber vegetables
Crop Group Tol. to be est. for root and tuber vegetables
Crop Group Tolerance to be established for fruiting
vegetables (except cucurbit)
Tolerances required under 40 CFR §180.103 (a2)
Cattle, fat
Cattle. mbvD
0.05
0.05
0.15
0.30
Tolerance increase to include THPI in expression
Tolerance increase to include THPI in expression
     .
i'ii! ..... !"
                                                                                            ..... ............... >7 A
                                                                                      ;   ...... '  ...... ,„;„,,"  ,/u
                                                                                     :;,:* , ......   s   « ...... ;ii( ;y., ' v;   ! ..... ,:    ;
                                                                                                                                                                                                          HK * -4
:!iai!I, IIHlillFII:!!1!,
                                                                       ,! ill..!!!'';,  i1,.!:: i:,i,,:	Ill	''Hill ^l

-------
*
Commodity
//
Cattle, meat
Goats, fat
Goats, mbyp
Goats, meat
Hogs, fat
Hogs, mbyp
Hogs, meat
Horses, fat
Horses, mbyp
Horses, meat
Milk
Sheep, fat
Sheep, mbyp
Sheep, meat
Current
Toleranc
re
fppm)
0.05
None
None
None
0.05
0.05
0.05
None
None
None
None
None
None
None
Tolerance
Reassessment
*
-------
•llMllll I lull III iiillllll1  II•III' II
II III 111 II III 1 III II 1111111 1 II II 111111 II Illl II II 111 II I 1 II 111 II III 111
Commodity
Strawberry
Tomato
MRL (rag/kg)1
20
15
i mil mi ill n inn i i i in mi n i nn in iniiiii i in in in i in i in
US Tolerance (ppm)
25
0.05
in 1 1 1 i n i ill M n i ii n n in in ii
Recommendation
US tolerance to be decreased to 20 ppm
US tolerance to be revoked; to establish crop
group tolerance for Fruiting Vegetables
(except cucurbits); seed treatment only
                       All captan MRLs are final (CXL).
                       JMPR 1990 had proposed to withdraw the CXL in view of no expected uses.
                                     ,         .
                                    concusions can be made regarding eforts to harmonize the_ U.S. tolerances
                                     ..._. ..... _. ..... ,,.,.,.-_._-_..  ._,_™^_^._.__,...._^^,,,.. ....... ,,„,,,,,  _
SEiiJSKSiE , fir"' K^'^LirtSffipatibility between U.S. tolerances and Codex MRLs exists for apples and pears.

  ~^;	^^riS'i."	ii^JNP.	questions of compatibility exist with respect to commodities where: (1) no Codex
                      MRLs.have	been,	establishedbut	U.S.	tolerances exist; or (2) Codex MRLs have been
                      established but U.S. tolerances do not exist.
[[[

                             a.     Human Health Risk Mitigation

                                    (1)  .......... Acute Dietary Mitigation

                      Acute dietary exposure is below the Agency's level of concern for the population of
               concern (females 13.50 years of age).  The 99.9th percentile of acute exposure through food to
               females ll-SO, years occupies 36% of the acute PAD. No additional mitigation is required.
                                                                                    "i
                                    (2)    Chronic (non-cancer) Dietary Mitigation
                                                                                  I
|||U |i ill mi i in ill,! 11 i  |^ |i i II	KKJJjJg	chronic dietary risk from cagtan is below fee Agency's level of concern. The most
111	I IB ' 11J I exjpose'd groug is iSante less jSan 1-year old. The exposure to Siiis group occugies less than 1.3%
™'"'ll'" ''ll"1 |l"	'"' 'ofthechroniclAD.	No	a33ffionaimiti^Bbn"is	required	
 [[[

                                    (3)    Chronic (cancer) Dietary Mitigation
                      The dietary cancer risk for captan is below the Agency's level of concern. The upper
               bound dietary cancer risk was calculated to be 1.3 x 10"7 for all registered uses of captan,
               including refinements such as processing factors and percent crop treated data.  No additional
                   __,,_,__,,,_, [[[
                                    (4)    Worker Mitigation
                                    M' [[[ (I [[[ ;
                      Agricultural uses of captan must have MOEs (Margins of Exposure) greater than or equal
               ^o 1,00 when considering short-term and intermediate-term scenarios, for both dermal and
                                                           "72
                                                           ' "   "
                                    > " JLV '.idnHMiiiKi,, ' ...... ', ..... 1111:1,9 ........ ir1"!:1 ..... imp ...... .iinnriiLr ...... :n ...... '' ....... :" >:,:"' 'iiii|iiin* lll;i;>'l
-------
 inhalation exposures. Additionally, since captan has been classified as a carcinogen, the
 occupational cancer risk considers both dermal and inhalation exposures. As a general rule,
 occupational cancer risks should be in the range of 10"4 to 10~6 or lower. For captan, carcinogenic
 risks vary from 1.3 x 10'5 to 1.7 x lO'9.  Thus, no additional mitigation to address occupational
 carcinogenic risks is required.

 For Mixer/Loaders

       Wettable powder (aerial application): The total margin of exposure (MOE) for workers
 mixing/loading a wettable powder formulation for aerial application is 41 even with the use of
 chemical-resistant gloves and a dust/mist respirator. The Agency will require water soluble
 pouches, and chemical-resistant gloves to mitigate the risks when mixing/loading wettable
 powders for aerial applications. With this mitigation the MOE becomes 1000. A chemical-
 resistant apron is not required since the high inhalation exposure is the primary factor in requiring
 the use of water  soluble pouches.

       Wettable powder (chemigation application):  The aerial application scenario will be
 used as the surrogate for chemigation. The Agency will require the use of an engineering control
 (water soluble pouches), and chemical-resistant gloves to mitigate the risks when mixing/loading
 wettable powders for chemigation.

       Wettable powder (airblast application):  The total MOEs for workers mixing/loading a
 wettable powder formulation for airblast application of captan range from 270 to 530 with the use
 of chemical-resistant gloves and a dust/mist respirator. The Agency will require the use of
 chemical-resistant gloves and a dust/mist respirator when mixing/loading wettable powders for
 airblast applications.

       Wettable Powder (groundboom application): The total MOE for workers
 mixing/loading a wettable powder formulation for groundboom application of captan is 710 with
 the use of chemical-resistant gloves and a dust/mist respirator. The Agency will require the use of
 chemical-resistant gloves and a dust/mist respirator when mixing/loading wettable powders for
 groundboom applications.

       Wettable Powder (greenhouse - high pressure spray): The total MOE for workers
 mixing/loading a wettable powder formulation for a high pressure spray hi a greenhouse is
 approximately 43,000 with the  use of chemical-resistant gloves and a dust/mist respirator. The   -
Agency will require the use of chemical-resistant gloves and a dust/mist respirator when using a
high pressure spray.

       Wettable Powder (golf course - ground equipment): The total MOE for workers
rnixing/loading a wettable powder formulation for applying by ground equipment on a golf course
is 240 with the use of chemical-resistant gloves and dust/mist respirator.  The Agency will require
the use of chemical-resistant gloves and a dust/mist respirator for applying by ground equipment
on a golf course.

                                           73

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                             ie Powder padding to paints or adhesives - industrial use): The total MOEs
                                 " Ład!ng a |wettable powder formulation for adding to gainis and adhesives in a
                                           from	1,400	to	5,400 wj5 tiie_ use	of chemicS-resistaS gloves and
               I dust/mist respkator. The Agency will requkethe use of chemical-resistant gloves and a
               dust/mist respkator for adding captan to paints and adhesives.
                                                                                                          	!	i
        :SaJle
                                       .Cseed treatment): The total MOEs for | workers mixing/loading a
             [[[ : ............ : ...........                  .                                    |
     ' ..... . .................... : ............. :::: i ........ ....... ^gggglg ppW3er formulation for a seed treatment such as use in a hopper box range from 78 with
                                                  12,000 with the use of chemical-resistant gloves and a
                               r. The Agency will require the use ^chemical-resistant gloves and a dust/mist
            ..... j!![resp irator for handers who are treating seeds.
    ll-iiWIIlUllliilliil!
    iifiiACinriiinw!111!
                                               • used as the surrogate for the use of a dust
  formulation for soil and greenhouse bench treatments. The Agency will require the use of
  chemical-resistant gloves and a dust/mist respkator for handlers working a captan end-use
;Łproduct: into tEe soil and for handlers seeding and transplanting into the treated soil immediately at
   ie'tlrie of application.
        	MVEOT	'mi	     	;	m	r	ram	Kiftiiii!	u	wwKi'i*i3Mtfi	111	>	iiir	"	i	iii	wm.	            I
   o
         :"i r f'" " \ liiiiini , jpigF         ' ''i'*"i» iii:H     «* «* ' .iiSiiHuniF ...... i*u, ' m aiii ^ji*"; •,' ji'w  dtt\i <\   ,, :   vi ,; M'' § lit :  iiiiiiiiLii i ii"1! ,,i "! j: !f :!':'• iiiHH iiiiinu , jiii jumiiii:: LRhH  iii lii
         ''IfS^                             ...... dips): The total MOE for workers mixing/loadmg a wettable
                owder formulation for preparing a solution for dipping apples, pears, or cherries is 1,200 with
               li IIHIIIIIIIHIS1 llii!!!:<;illlliiiiiillllllligilllliliilli Illllllllllllllllllllllllllllll UlillllilllilllllllllllllllHi:* ...... IIIIIIIIIHIIIIIIII'liUiii ..... ................... nii ........................... „. .............. Mil ..... ......... ....... V\. ........... ,1 ............ "Ilium ........ I ............ ' ...... mill ................... ' II1:" ............... ,r ..... fS,i,,i, nil ..... .................. fcm .............. Aimii .............................. \, ..... in ............... , ........................... •, < ................. „ ........... I ......................... , ..... ..... ................ i .............. . ........................................ JH ...... ................................... ............... .......................
                                            v^ and a du^mist respiratOT. Thus ttie Agency will reguire the
                                             ) :  The total MOE for | workers mbdngAoa^ng a liguid
                                                                                                  e*
                            ii  -    .-™—™ ™       -         ,   -    ,, ,
                       Agency will requke tEe use of chemical-resistant gloves when rnixingTioading
SLZTrr"-^ ;; ..... " ....... .1,1HJi>!!' I!! Illllil! i ,,i:t7' IP
          a	;	a

-------
 used on seed potatoes, which can then require cutting and sorting. The Agency will require that
 handlers using open bags of treated seed wear a dust/mist respirator, chemical-resistant gloves
 and eye-protection.  Captan end-use products that can be used to treat seed potatoes will require
 the use of a dust/mist respirator, chemical-resistant gloves and eye-protection when cutting and
 sorting treated seed potatoes.

 For Applicators

        Aerial: At baseline, the total MOE for workers applying captan using aerial equipment is
 2,500. No additional mitigation is required.
       V
       Airblast: At baseline, the total MOEs for workers applying captan using airblast
 equipment vary from 240 to 1,100.  No additional mitigation is required.

       Groundboom:  At baseline, the total MOE for workers applying captan using
 groundboom equipment is 11,000. No additional mitigation is required.

       Planting of Treated Seeds (including potato seed pieces): At baseline, using captan
 specific data the total MOE for the observer riding on the rear of the planter was 2083. No
 additional mitigation is required.

       Golf courses (ground equipment): At baseline, the total MOE for workers applying
 captan to golf courses using ground equipment is 3,600.  No additional mitigation is required.

       Paints (brush): At baseline, the total MOE for commercial painters applying captan
 containing paint using brushes is 690.  No additional mitigation is required.

       Paints (sprayer): The total MOE for commercial painters applying captan containing
 paint using a sprayer with the use of a dust/mist respirator is 72.  The Agency will require the use
 of a dust/mist respirator and waterproof gloves when applying captan-containing paint with a
 sprayer, which results in an MOE of 160.

       Paints (roller): Although no data were available to assess the exposure from this
 scenario, the Agency does not expect the risk to be significantly higher than that of the paint brush
 scenario. No additional mitigation is required. However, the Agency will require submission of
 data to assess this scenario.

       High Pressure Spray: The total MOE for workers applying captan using high pressure
 spray equipment is 5,300 with the use of chemical-resistant gloves. The Agency will require the
use of chemical-resistant gloves.

       Post-Harvest Fruit Dip: There are no activity specific data to address the use of a
solution of captan as a dip for apples, cherries, and pears. Once the solution has been mixed,
most of the application is mechanized (such as operating fork lifts) and the potential for exposure

                                           75


-------
       Seed Treatments: The Agency is establishing a 12-hour REI for seed treatment uses.
 Exception: Once the seeds are planted in soil or other planting media, the Worker Protection
 Standard allows workers to enter the treated area without restriction if there will be no contact
 with the soil/media subsurface.

       Strawberries, Almonds, Apples, Apricots, Cherries, Nectarines, Plums/fresh Prunes,
 and Peaches: Based on the risks that were calculated from the submitted strawberry and peach
 data, the Agency is establishing a 24-hour REI for strawberries, almonds, apples, apricots,
 cherries, nectarines, and peaches.

       Blueberries, caneberries, and grapes: The risks that were calculated from the submitted
 grape data were MOEs of 60 on Day 2 and 170 on Day 5.  Since the target MOE of 100 would
 be achieved between Day 2 and Day 5, the Agency is establishing a 3-day (72-hour) REI for
 blueberries, caneberries, and grapes.

       Ornamentals:  The risks that were calculated from the submitted strawberry data, as well
 as data from other sources, considered that ornamental workers could work with captan-treated
 plants from three to six hours per day. Working three hours the MOE was 400 on Day 1.
 Working six hours the MOE was 100 on Day 5. Due to the uncertainties in the number of hours
 that workers would be in contact with captan-treated soils and plants, the Agency is establishing a
 4-day REI for ornamentals, which is the REI that is on the  current labels. The current labels
 allow early entry for an unlimited length of time during the last 48 hours of the REI, provided
 early-entry PPE is worn.  For ornamental uses only, this will be maintained.

       Soil Treatments: Based on the interim WPS REI policy, the Agency is establishing a 48-
 hour REI for soil and greenhouse bench treatments. Once  the treatment, and immediately
 following seeding and transplanting activities are complete, the surface of the soil cannot be
 disturbed for 48 hours.

       Sod Farms: Based on the interim WPS REI policy, the Agency is establishing a 48-hour
REI for sod farms.  The Agency is also establishing an additional harvesting prohibition interval of
48 hours.

       Early-Entry PPE: The following early entry PPE is required: long-sleeved shut, long
pants, coveralls, shoes and socks, chemical-resistant gloves, and protective eyewear. Double
notification is not required. Protective eyewear is required because captan is classified as toxicity
category I for eye irritation potential.

       Eye-Protection: In addition to the entry restrictions discussed above, the Agency is
establishing additional post-application requirements due to eye irritation concerns. Under the
Worker Protection Standard a 48-hour REI would be established for captan. However, by the
end of the 48-hour interval, the residues from captan would not necessarily have dissipated to a
level where eye irritation is no longer a concern. The information available to the Agency
indicates re-entry incidents can occur 5 to 8 days after application.  Due to the uncertainties in

                                          77

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                                                                I
               determining a set time interval when eye irritation from residues are no longer a concern, the
               Agency sought an alternative to an REI as the only means of adequately mitigating eye irritation
               Concerns,.  To mitigate eye irritation concerns from post-application exposures, the Agency is
               fe'cfuiring that, for at least seven days following the application of captan:

                       — At least one container designed specifically for flushing eyes is available in operating
                           Jition at the WPS-required decontamination site for workers entering the area treated
                      ldthcaptan, and
"'
'sriJ™ • ~= ..... ":,•;•:: =?v-!t*~-!~-Worlcej:s are uiformed orally, in a manner they can understand:
........ , ................ , ........................... „ , ........................... , , ,.j ..... ............ ;, ......... , ...... , ........ . ....... , ................ , ....... , ................. . ....................... ij ............. ,- ..... jBiBiil ........................... ,,, ........... that residues in the treated area may be |2gg|y irritating to their eyes,
!=lBSiiias! ..... „ ........ us =i3ifi>=™*=; '•.*».• ........... j .................... i ............ tihatjhey should take precautions, such as refraining from rubbing their
              KS^&fjSBB;, ^l?SSi"jyes, ...... and to keep the residues out of their eyes,    [
                             =     that if they do get residues in their eyes, they should immediately flush their
                                     eyes with the eyeflush container that is located at the decontamination site,

                                          ,to. ..... operate the eyeflush container.
             ' B' IIIIKl'LillilillililUT!: 1

                                                                                                 .nlllllllt'lllilh'llll i 	„!, l|"!B'li(I|;,

                                                                                                    are
               For each use scenario of captan.  These PPE are required either to mitigate a risk that was
             ..i^^tlG.ed durjing the reregistration process, or because the risk assessment supporting
          	, TI i	«m	in1' iiii
VW'iif'iMStimP	"Ill
H^rlw'iibiiyKi	iJiiirvi
iit'i1!;!!!'"tiKiiiii	IIIIH^^^  iiiiiii  .'ill1;,: i • • :iiLi;x:!:i;'ii[;ittito^^^^^^^^^^	iiiiii: ";iiir	i!'!,*:!1!"1!1 :i! .if:1:1 a	b <  !• ma	• ::i'>,
iM'fmmm>m	'4	w.	HK>miiiif/E	i"	i;sr	ms	to; &&;'>»!,•	M.	i	M
siiiu^''?.;:•.*>-•	r;	;	-.lasri.^	riiii	iau	-a	s^Mc^r
                                 IW' %» . "!
                                                                                               1;,	w
                                                                                                      :^:;t	'Hi;!,!	lillHIl
                                                                                                      iiii:	             I
                                                                                                     ,i"i< i,' '5'"! J '""SKSr
                   	K:	,'i	MJJII	;:iiii	SIEXJIH	liiiii
                               ,i»


           111	 lllllllllllllllllllllllll|l||il|i|  I 111"'In I  III Nil 111 ili I 111 111  II  111  111 II

-------
Summary of Required Worker Personal Protective Equipment
Exposure Scenario f~
i " y- "*"
Mixing/Loading WP for aerial or
chemigation
Mixing/Loading WP for airblast,
groundboom, high pressure sprayer, golf
courses
Adding WP to paint at manufacturer
Mixing /Loading WP for seed treatment
Mixing/Loading post-harvest fruit dips
Mixing/Loading wettable powder or dust
for soil and greenhouse bench treatment
Mixing/Loading liq./flowables for aerial,
airblast or groundboom
Handling treated seeds
Aerial, airblast, groundboom application
Planting of treated seed
Application to golf courses (ground
equip.)
Applying ready-to-use paint with brush
or roller
Applying ready-to-use paint w/ sprayer
Applying High Pressure Spray
Operation of fruit dip process
Mixing/Loading WP or liquid flowables
then applying w/ low pressure handwand
Mixing/Loading then applying w/
backpack/knapsack
Mixing/Loading then applying as root-
dip
Flagger
Baseline
PPE ,
Required
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
Additional PPE
~ J Required J *
Chemical-resistant gloves
Chemical-resistant gloves,
dust/mist respirator
Chemical-resistant gloves,
dust/mist respirator
Chemical-resistant gloves,
dust/mist respirator
Chemical-resistant gloves,
dust/mist respirator
Chemical-resistant gloves,
dust/mist respirator
Chemical-resistant gloves
Chemical-resistant gloves,
dust/mist respirator,
eye protection
no
no
no
no
Water-proof gloves,
Dust/mist respirator
Chemical-resistant gloves
Chemical-resistant gloves,
Chemical-resistant apron
Chemical-resistant gloves
Chemical-resistant gloves
Chemical-resistant gloves,
Chemical-resistant apron
no
Engineering
Controls
water soluble pouch
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
restricted to
mechanical
operations only
n/a
n/a
n/a
n/a
79

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IIIIK  	Illi'i il III	V^fi ilnl	In'(111	Hi 111 III'l  I	lull	
                                 	,  "I1 III
                                                          11	Ill L I  < I ill' ii  Dili I	
"iili'il'j	In    n'l	' I1 ,1	FlitH LIN	I	Il
                                    (5)    Residential Mitigation
                                          Ill 111 II III   III hi I1 III II  111 111 111
                                                            iii iimn i i	in nil iiiiiiiiiii i	iiiiiiiiiiiiiiiii  i	il it
                                                                                                   1 lull HI I m1 i HI! Ill lHliill  lllllinii
             	Handler
                      Residents (homeowners) may purchase captan formulated as a wettable powder, dust or
               liquid or in a ready-to-use paint. Thus, residential exposure can occur when applying paints
               So'nfauiing captan with a brush, a sprayer, or a roller.  Other exposures can occur when
               homeowners mix and then use a captan-containing solution to treat their fruit trees and
               ornamentals. Data were not available to assess applying paint with a paint roller,
               mixing/loading/applyinga solution of captan as a dip treatment, or loading/apply ing a dust
               formulation with a shaker can or in a bag. The Agency is requiring the submission of exposure
               data to assess these scenarios (see Section V). The MOEs for all other scenarios are greater than
               100, therefore, no additional mitigation is required.
          	I   Illiiiillllil
           Post-Application
          11	IH	.;,••	IIIIIIIH	ill	ftK iPVtflft : \ • liiilt	i^	i:	i 'i*'»	I	" lilKt	,l!i	":",:••:; iiilllill:	!	i :ni II'	,	m"f "f I'lllli	IMS	11
                                                                         	I: ,
llllf'IIJ'ii '.111! I I 'I'"
  lib'UK III I If fi II	ill 11
                    jostapplication exposures and risk to youths and adults playing golf at golf
    courses did not exceed the Agency's level of concern. The Agency determined that the MOEs are
    over 100?000 for youth and adult golfers, respectively. Therefore, no mitigation is necessary.
   mini ii ii  i  ii inn mi ii  iii iii   n i ill n  mi  in i  i i  i in  i n n    MM   n n  i n      mi   in i n   i in ii ill  iii i  mi nil  i inn i  nil    MM      in  n nun mini in  in mini  HIM
   III 111 I III I  III I Hill  II11II 111!  Ill 111  III  I  III  I I ll| III  I!  II   I  Illllllll I  I III   III   I   I III II Illl  I  II III!! Mill    I   I    I               II I     II
           Around the home both adults and children can be exposed to residues of captan that
                      nation, is complete. Based on the available data both dermal and inhalation post-
    application exposure from captan-containing paints is expected to  be negligible. All MOEs for
    both adults  and children were greater than 100; no additional mitigation is required.

   	      (6)    Drinking Water Mitigation
   1 n  iiiiiiin i  i   in 11 n n linn n  mi iiiinni linn     n nn i i  n n nil   i  in HI     in   nil      in n i iq i  i in nun     i  |i        n M i      inn i i  nil in  iiiiiiiipiiiiiini  i i

           The Agency's upper bound estimates of acute, chronic, and carcinogenic drinking water
    exposure  are below the appropriate Drinking Water Level of Comparison (DWLOC).  Therefore,
  •;; JhejiskJram^drinkinjg water is below the Agency's level of concern. No additional mitigation is

                     •;;	 ~ ;;	; , 	;;;;  • -_  	_; -	•;;	;	; -\ "  ; -;-;;• 	~  "•_	 j1;:	-. ,  •;	 ;  t ;; ;:;;:":":,, '.;	;..;	'',;,
                          (7)    Aggregate Mitigation

                     led earlier, aggregate acute or chronic (non-cancer) food and  drinking water
    	,	I,	•	•	I,,	,	,;, •	urttfiiittlHM	«•	"«	=	=	- •" ~—:	-	•'	•	>	- •	•	;	•	Ł " ™	;	••	*? - - • 	
    exposures are not expected to exceed 100% of the acute or chronic PAD, respectively. No
    additional mitigation is required.
™ •  ,;                                                                                              i
i'11,"!,! • i ii nil HI  i iiiiiiiiiiiiiiiii  n iiiiinin i inn iiiiiiiiiiiiiiiii niininn ininini   inn  in    nil in  n in  n i     in in i i      i in   inn  in in  nn n 11   n in i inn I  inn in in i  n    i   n  i  i in in nip in  nnninni i n |
           Generally, an aggregate carcinogenic assessment considers dietary (food and water) and
    residential (handler and post-application) exposures.  The Agency considers residential post-
    ipplicationexposure to captan from its use hi paints to be negligible because dermal and
    inhalation exposures are likely to  be minimal. Therefore, the Agency has considered only
    residential handler exposure together with dietary and drinking water exposure in its aggregate
    risk assessment- The aggregate cancer risk, including drinking water and residential handler
   ',                                                           '
   I                                                                i       i
   1111111   i   1111   1 ill   111 ii!in    i nil  inn i n n   in     n i   n  n    Qf\


   !                                                                       i
   4                                                                       II                      I
   i                                                      I                 I
      liillil (	II 111 11 Ililill  tlift II IIIIIIIH III Illllllll HI 11 Illl	llilliHillill 111 llillll  111 iilllli Hill iliiilillll I	                                                   	I	

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 exposure, as previously explained, is less than the Agency's level of concern. No additional
 mitigation is required.

        A short-term aggregate risk assessment considers consumption of food and water and
 short-term residential exposures. Residential exposure from use of captan on fruit trees and
 ornamentals does not exceed the Agency's level of concern when aggregated with food and
 drinking water exposures. Exposure to adults from painting aggregated with exposures from
 food and drinking water also does not exceed the Agency's level of concern.

        However, the use of captan results in post-application hand-to-mouth exposures to
 children which do exceed the Agency's level of concern. Since these post-application exposures
 alone exceed the Agency's level of concern, an aggregate assessment which would only further
 exceed the level of concern was not performed.

                     (8)   Ecological Risk Mitigation

                     Mammalian and Avian Mitigation

        There is a chronic risk to small herbivorous mammals following multiple applications at
 application rates greater than 4 Ib ai/acre. Only reducing the label application rates can reduce
 these risks.  However, the Agency does not expect chronic risk to occur since application rates
 are generally less than label maximums and the only uses with rates greater than 4 Ib ai/A are
 almonds (at  4.5 Ib ai/acre) and turf at sod farms and golf courses (to be reduced to 4.3 Ib ai/acre).

                    Aquatic Species Mitigation

        Captan is acutely toxic to fish and exceeds acute high risk for  fish for all application rates,
 except cherries. Chronic risk to fish is not anticipated at any of the single or multiple use rates.
 The Agency will require protective measures for foliar applications similar to those for aerial
 applications to minimize exposure due to drift and run-off to aquatic sites near the crop treatment
 area. Additional data are needed for a complete risk assessment to further assess risks to
 estuarine and marine organisms.

              3.     Occupational (both Worker Protection Standard and non-WPS)
                    Labeling Rationale

       During the reregistration process, EPA considers all relevant generic and product-specific
information to decide what protections and risk mitigation are needed for all products. Products
may be used in various occupational settings, which may or may not be covered by the Worker
Protection Standard (WPS).

       The 1992 Worker Protection Standard for Agricultural Pesticides (WPS) established
certain worker-protection requirements (personal protective equipment, restricted-entry intervals,
etc.) to be specified on the label of all products that contain uses covered by the WPS. Uses

                                           81

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                           •Ill, i:V!< !• liilllllitri lilL1 iiiii/lSIIIIH liliili ,!>:ii >	, ,3; Ilii;	;, '':3Him:im ', ii.I:!IU«!!Jl'.! : "<••	• 5, f.; t	lai1'!! •11	Xil if 111 :«	H	l;>	Ill'!!',:: '«	!> Ill :'
              covered by the WPS include all cornmercial_andm research uses on farms, Jorests2i nurseries2 and in
              gre'enhouses to produce agricultural plants (including food, feed, and fiber plants, trees, turf grass,
              flowers, shTubs, ornamentals, and seedlings), the WPS covers not only uses on plants, but also
              uses on fee soil or planting medium fee plants are (or will be) grown in. The WPS labeling
              requirements pertaining to personal protective equipment (PPE), restricted-entry intervals (REI),
              and notification are interim. These requirements are to be reviewed and revised, as appropriate,
              during reregistration and other Agency review processes.
                          ,SŁS.]^py products that contain captan.  Some products containing captan are
             -|n|e|||ed, primarily for occugatipnal use and some are intended primarily for homeowner use.
             ;:Most of fee occupational uses are covered under the

                     Personal Protective Equipment for Handlers (Mixers. Loaders, Applicators, etc.)
    BJIL! ill!!!!! a"i s Ili
                                i;^:j||«^^^       	ll'ill: Jill	uWK!	EI«^^
                                                                                                       „ «•	ii.,	' ii;
                                tective equipment requirements usually are set by specifying one or more pre-
                            ; units — sets of j|erp§J|i|t are,	ajmo,sj; a|w9y_s required together. For example, if
                              " -*~~res are^^f^^^>^^'^j^^^^'^^''^^.P^^t?9'9^? a^shoes are"	
   linillllilllllli'l^ilUlni	Ill	
                                 ..           ,,,,,,, ,.,
              of body profecSon (coveralls over a long- or short-sleeve shirt and long or short pants), the
              minimum must also include (for all handlers) chemical-resistant footwear and chemical-resistant
              headgear for overhead exposures and (for mixers, loaders, and persons cleaning equipment)
                    For eacJi end-use product, PPE requirements for pesticide handlers will be determined by
gmgpp ..ijiii,,, y,' liiS^illSJS^r^^ fee PPE requirements based on fee toxicity of fee active iingredient, as listed in ^the           I
	liiiMM^ii'''.^^^	^iJierlableTwiSi'ffie'	PW're^uireS''b"ase3	oatiie'acute	toxicity	oYl^lllle'n"3:u^'prQgu-cŁ
              stringent choice _for each type of PPE (i.e., bodywear, hand protection, footwear, eyewear, etc.)
                          :o the end-use product. As discussed in fee risk mitigation section above, fee
                    ' ....... Post-Application/Entrv Restrictions

                L1;:; ...... DUnder fee Worker Protection Standard (WPS), interim restricted-entry intervals (REIs)
              for all uses covered by fee WPS are based on fee acute toxicity of fee active ingredient. The
            '.Itcedcity categories of fee active ingredient for acute dermal toxicity, eye irritation potential, and
              skin irritation potential are used to determine fee interim WPS REI. If one or more of fee three
              acute toxicity effects are in toxicity category I, fee interim WPS REI is established at 48 hours. If

             .....           M11ll     „—                  ,      ™™
         ''''"'"..f !!|a1egory ICfeT'interim WPS REI is established at 24 hours. If none of fee iSree acute toxicity
          """ ..... ........ ! ........ ggfects are m category I ..... or 'it fie ...... mterim ..... ^§""^Ł1 is ...... established at ..... 12'hbursT A 4»5ioiJr'REI is
           "^increased to 72 hours when an organophosphate pesticide is applied outdoors in arid areas. In
             addition, fee WPS specifically retains two types of REI's established by fee Agency prior to fee
         •;,!„•: !;;:;j,i: pjramulgation of fee WPS : (1 ) product-specific REI's established on fee basis of adeqiiate data,
                                 feat are longer fean those that would be established under fee WPS.

-------
        The WPS prohibits routine entry to perform hand labor tasks during the REI and requires
 PPE to be worn for other early-entry tasks that require contact with treated surfaces. Under the
 WPS, these personal protective equipment requirements for persons who must enter areas that
 remain under a restricted-entry interval are based on the acute toxicity category of the active
 ingredient.

        For captan, the Agency has determined that no regulatory action is needed as the result of
 acute or other adverse effects of the active ingredient.  The early-entry PPE requirements will be
 established on the basis of the acute dermal toxicity category, skin irritation potential category,
 and eye irritation potential category of the end-use products.

              4.     Other Labeling Requirements

        The Agency is also requiring other use and safety information to be placed on the labeling
 of all end-use products containing captan.  For the specific labeling statements, refer to Section V
 of this document.

                     a.     Endangered Species Statement

        Currently, the Agency is developing a program ("The Endangered Species Protection
 Program") to identify all pesticides whose use may cause adverse impacts on endangered and
 threatened species and to implement mitigation measures that will eliminate the adverse impacts.
 The program would require use restrictions to protect endangered and threatened species at the
 county level. Consultations with the Fish and Wildlife Service may be necessary to assess risks to
 newly listed species or from proposed new uses.  In the future, the Agency plans to publish a
 description of the Endangered Species Program in the Federal Register and have available
 voluntary county-specific bulletins. Because the Agency is taking this approach for protecting
 endangered and threatened species, it is not imposing label modifications at this time through the
 RED.

       In the future, the Agency plans to publish a description of the Endangered Species
 Program in the Federal Register. EPA is in the process of developing county-specific bulletins
 that specify measures to protect endangered and threatened species. Although bulletins have not
 yet been developed for all counties where they will be needed, EPA has completed and distributed
 over 300 county bulletins.

                    b.     Spray Drift Management

       The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and
 State Lead Agencies for pesticide regulation to develop the best spray drift management practices.
The Agency is now requiring interim measures that must be placed on product labels/labeling as
specified in Section V. The Agency has completed its evaluation of the new data base submitted
by the Spray Drift Task Force, a membership of U.S. pesticide registrants, and is developing a
policy on how to apply the data and the AgDRIFT computer model to its risk assessments. After

                                           83

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i«iiui	ill  i  i mil mtft 'iiiiiiifiiiiii"!	i IB i iii'iiiitiii	iiiiiiiniiiiii'i	i	PI i11 •"ill  ni ini  '("	
                                                                                        'Ill If I	l|ni
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                                                                                                                                111iiill1 (I
                                                                                               K^	!	1!!
                                                                                                 I
               |he policyisi5L.J6^BS.?»_'^5.^Ł?SJ5?y. i?1?086 further refinements in. spray drift management
               practices to reduce off-target drift and risk associated with aerial as well as other application types
                      	appropriate.
                                                                          •ll'lililiH^^^	1IIIIIK	IIIM^^^^	lllilKI
                                                                  i»^^^^^^	EilIB    	IM^^^	IIP:
                         istration of both manufacturing-use and end-use products.
                       "A,     Manufacturing-Use Products
                                                    1 Ilili'i!	II,'! jIIIBB'Itllilil!1!!;!jlinRiiilililfiJi'':	II' iif'iWIlllllllB ill; il, ,IK;! Vjlliil'"JiJiHilJII v
                                                             i "Hiii'iis ''ii: qnik •; 'ii::: iir in, innibiii ill1: A\ JIPKI „, j nin «TK "iiiiiiiiiiiiii:! .iiiniiiiiiiiiiiiiiiiiliiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiyiiiiiiii; iiii
                                                             	,!	i:••• iiiiin':? iiiiiiiiiin	• i,,", rr\ >q f, m: fat	NK y^m* fwrnnv'"> •
                                                                                                   JlllllllllABilll'pC'iliiIji "iji»i '|i T|i||ii||ijp !'l'i|l; , ;I|MI|;I j, [jnliilH > J|

                                                                                                   iiiiiiaitJ!1''!'!:!:,,;!1'1 liiiiHihiii':,! j'lSiHSiii'iiili'	;,,l>l!!!ll!,|:!!ii|||!iil|||| Ifi	!!i, inHi'ilil! ''I'lini!,'!,!;:	ii"i,|,,; ;»||i|||||||||||h,, ::; „„ "f	"S,'
   'M	9	Illilllllllllllllllliii1 >,i,i,!!!l!!l"i;ilhllil<'l
                                               iiii.i.iiiiLiii1,!;!!!"1:,„:.ni!;;1"",i! .i,,!*.'.?. •: ":i':!i|!!iulgi:iiiiLLiiiiiiiiJfgikijiiiiiigiiiiiiii,1!!:;;1'!;!:;' "i •,;;<
                                1.       Additional Generic Data Requirements
                                                                                         ii' i!;,,!;1!!!;!;1, pJfttfl 'diJiiillliUFIiirjiii,''!;', 'l'1'; ^'m	liillii, ;:"!!|i';nF', MIL'.	„ '>!, Jllllllii'lillliyl'llligfiedlllllllllll1, \ i\iKW^	lll'liill11

                                                               '"'''. ^::/i™:!""-ir:~^"!r:^^.:i:j'i*
                       :The, ..... generic ...... d_ata base supporting the rerejistetion of cagtan for the eligible uses has been
                                                                                               ,       ,     ,,
                                                 active ingredients and the formuation intermediates.  These
               requirements will be specified by registration number in the Data Call In Additionally, the
          .......................... ;" following guideline data requirements must be provided to suggort the continuing registration:
[[[ - [[[ 81-1,
                                        Acute Estuarine/Marine Toxicity - Mollusk
                                        Acute Oral Toxicity (rat)
                                        Acute . D,ennal,Toxicity (rat/rabbit)
IIi. ,ili .i'lniin Ti1 !iii. I IIF I' , iln ' ,i* I ...... !'« I ' ,  Illliliillil! i ' INIIII !!' llllillili ' r» ' ..... ilnJ lijiiiin' ''
                                   )	„,„	Inhalation Exposure
                                   nir:!'	,,r!,,,, iiih'iiiJiis'^i^jiiiij^Jr^^iiiiiii    iii^irAiiiTi/,,	ru,	,	,i,	u • 'i<<<	"	,	•	i
                :;,, 	      	   •'   	  	     i      	     	   	    ,, ' B| •	, ii	,' I' 	 i  	   	 ' ' 	  ,	I

  M' '..ll'i ihiiillliillllllllilllli .jilliUiiil,,,,  Illifl" i i!!lli!lluni i1;'14 lull Ilillirilillinnilllllli.!111 Jliillllliiii''''^^!!!!!!!!,,,: jillliilllllllllllllL/lllllllllllllllllllllllllllllilllhHIli jlllH »,ii,iii 	 i>,'llll|||,'iflll!|i i,ill!i:,i,,,, >",!	11	H'llillliU'/'iJlllHllli'T'lii1 I/,  illll!""illll|"ill1,llllllLllll|iil'i|l||"|liil lllllllllllllllilWlLMHIIliiu 'lllllllllllhiliii:, 'I'jIiLI'iliJlllllllillilii'lllllll, I ,  	 "	    	
	'	'	'	I	'	"!!	!	""2»
                                          Labeling Requirements for Manufacturing-Use Products
                                     ,                     .
                            co
                                                                                                                ,
                                                                                                          icies! ........ Tne"P" .....
              .abeing must bear the labeling contained in the table at the end of this section.

                                 llllliClllilllililiiii'lnilillliilllllliiili''''!!'!!,,.!! ""illHiliililll'i "':	iflllim '	 il|ii," lillllti'HIB'1 lii'i'illiliLLllliniliUii, 'mlliili-li1!
                     ia^^^^^^^^^^^^^^^^^^^^^                 	*mm	m	mm	mM«	x,m
                               iiii!	         	JIM        	Hiiiiiii	         	iiiiiia^^^^^^^^^^^^^^^	IB^^^^^^^^^^^^^^^^^^^^^^     	i	iiiiiLJa	id^^^^^^^^^^^^^^^^        	H!	w        	ii|
                               Required for root dip treatments - Conduct studies concurrently in indoor and outdoor sites. The
                               studies must be sufficient to account for both the occupational (peach pre-plant) and the residential
                          iio=i scenarios.	
       	,, „:	_	,	,,„ „,	;|1 , .Required for |application of gaint by roller - See note above.
                               Required for residential appScation of dusts by s^ker can and in a bag.  Studies must be conducted
                          	Sclfllitly .for outdoor sites.
  I1H     	ill	^'MSS»	fftlti	!>'»                    	IE!,, in
:^^       	:t:	iiiK^^^^                          	imai*'	""

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       B.    End-Use Products

             1.     Additional Product-Specific Data Requirements

       Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. Registrants must
review previous data submissions to ensure that they meet current EPA acceptance criteria and if
not, commit to conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then study MRID numbers should be cited according to the instructions
in the Requirement Status and Registrants Response Form provided for each product.

             2.     Labeling Requirements for End-Use Products

       Label changes are necessary to implement mitigation measures outlined in Section IV
above. These changes include updated PPE restrictions, and ecological restrictions.  Specific
language to implement these changes is specified in the following table.

             3.     Required Labeling Changes Summary Table
                                          85

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ponds, estuaries, oceans or other waters unless in accordance with the requirem
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notified in writing prior to discharge. Do not discharge effluent containing this
systems without previously notifying the local sewage treatment plant authority
contact your state Water Board or Regional Office of the EPA."

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resistant material). If you want more options, follow the instructions for categc
E, F, G, or H] on an EPA chemical-resistance category selection chart."
All mixers, loaders, applicators, flaggers, and other handlers (including handlei
transplanting as part of root dip treatments) must wear:
- long-sleeved shirt and long pants,
- shoes plus socks.
- chemical resistant gloves (except for flaggers, pilots, and applicators driving i
- chemical resistant apron when participating in dip treatments.

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resistant material). If you want more options, follow the instructions for categc
A,B,C,D,E,F,G,orH]on
an EPA chemical-resistance category selection chart."
"All mixers, loaders, applicators, and other handlers (including handlers partici
transplanting as part of root-dip or greenhouse-soil treatments and persons hanc
treated potato seed pieces) must wear :
- long-sleeved shirt and long pants,
- shoes plus socks.
- chemical resistant gloves (except applicators driving motorized equipment),
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esistant apron when participating in dip treatments.
i NIOSH-approved dust mist filtering respirator with MSfL
C or a NIOSH-approved respirator with any N2, R, P, or H
ept (1) applicators driving motorized equipment and (2) m
in backpack, low-pressure handwand/handgun, and dip trc
•a igSt
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1 3 «S i f
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tective Equipment (PPE)
als that are chemical-resistant to this product are (registran
erial). If you want more options, follow the instructions fc
,G,or H] on
nical-resistance category selection chart."
oaders, applicators, flaggers, and other handlers (including
as part of root dip treatments) must wear:
ed shirt and long pants,
socks.
esistant gloves (except for flaggers, pilots, and applicators
esistant apron when participating in dip treatments.
O'CtSP-^ "" "" > »i *-i ,— ^ "-1
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otective Equipment (PPE)
als that are chemical-resistant to this product are (registran
If you want more options, follow the instructions for categc
\ chemical-resistance category selection chart."
oaders, applicators and other handlers(including handlers {
as part of greenhouse-soil treatments) must wear:
d shirt and long pants
sistant gloves
socks
Itering respirator with MSHA/NIOSH approval number pre
pirator with any N2, R, P, or HE filter
*i^g -jf S|iS2
fits IS -f 11-11
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Summary of Required Labeling Changes for














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"Follow manufacturer's instructions for cleaning/maintaining PPE. 1
washables exist, use detergent and hot water. Keep and wash PPE se
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"Engineering Controls"
"IMPORTANT: Water-soluble packets when used correctly qualify a
the WPS. Mixers and loaders using water-soluble packets (1) must w
mixers and loaders and (2) must be provided a NIOSH-approved dus
below), and (3) must have the respirator immediately available for us
broken package, spill, or equipment breakdown. The resph-ator must
respirator with MSHA/NIOSH approval number prefix TC-21C or a
with any N2, R, P, or HE filter."

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"Environmental Hazards"
"This chemical is toxic to fish. Do not contaminate water when dispi
or rinsate."

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"Environmental Hazards"
"This chemical is toxic to fish. Do not apply directly to water, or to
present or to intertidal areas below the mean high water mark. Drift
may be hazardous to aquatic organisms in neighboring areas. Do nol
cleaning equipment or disposmg of equipment washwaters or rinsate.

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"Do not enter or allow worker entry into treated areas during the restricted
entry interval (REI) of:"
"12 hours for planter box-type or hopper-box seed treatment uses. Exception: Once the s<
planted in soil or other planting media, the Worker Protection Standard allows workers to
treated area without restriction if there will be no contact with the soil/media subsurface."
"24 hours for strawberries, almonds, apples, apricots, cherries, nectarines, plums/fresh prii
peaches"
t
"48 hours for soil treatments and root dips: For soil and greenhouse bench treatments and
once the treatment and any seeding or transplanting tasks done as part of the treatment are
the 48-hour REI begins. Exception, once the seeds or transplants are planted in the soil, tl
Protection Standard allows workers to enter the treated area without restriction if there wil
contact with the soil subsurface."
"48 hours for sod farms"
"72 hours for blueberries, raspberries, blackberries, dewberries, and grapes"
" 96 hours for ornamentals. Exception: For the last 48 hours of the REI, workers may enl
treated area to perform hand labor or other tasks involving contact with anything that has
treated, such as plants, soil or water, without time limit, if they wear the early-entry PPE 1
below.
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the WPS-required decontamination site for workers entering the area treated wi
2. workers are informed orally, in a manner they can understand:
~ that residues in the treated area may be highly irritating to their eyes,
~ that they should take precautions, such as refrahling from rubbing their eye;
residues out of their eyes,
~ that if they do get residues in their eyes, they should immediately flush their
eyeflush container that is located at the decontamination site, and
-- how to operate the eyeflush container.










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Double Notification: Notify workers of the application by warning them orally
warning signs at entrances to freated areas."


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"Do not allow this product to drift."
"Do not apply this product in a way that will contact workers or other persons, e
through drift. Only protected handlers may be in the area during application."
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"Aerial Spray Drift Management"
"Avoiding spray drift at the application site is the responsibility of the applicator
many equipment-and-weather-related factors determine the potential for spray d
and the grower are responsible for considering all these factors when making de<
*- >,
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"The following drift management requirements must be followed to
from aerial applications to agricultural field crops. These requiremf
using dry formulations.
1. The distance of the outer most nozzles on the boom must not exci
wingspan or rotor.
2. Nozzles must always point backward parallel with the air stream
more than 45 degrees.
Where states have more stringent regulations, they should be observ
The applicator should be familiar with and take into account the inf
Drift Reduction Advisory Information."
t
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                                                                                           11	1!	!	!	1	5"'"11'!	h	'	II 'M|l	'	I	'	

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"CONTROLLING DROPLET SIZE "
"Volume - Use high flow rate nozzles to apply the highest practical
higher rated flows produce larger droplets.
Pressure - Do not exceed the nozzle manufacturer's recommended p
lower pressure produces larger droplets. When higher flow rates ar<
nozzles instead of increasing pressure.
S
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Number of nozzles - Use the minimum number of nozzles that prov:
Nozzle Orientation - Orienting nozzles so that the spray is released
larger droplets than other orientations and is the recommended prac
horizontal will reduce droplet size and increase drift potential.
Nozzle Type - Use a nozzle type that is designed for the intended ap
types, narrower spray angles produce larger droplets. Consider usin
nozzles oriented straight back produce the largest droplets and the 1<
Is
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"BOOM LENGTH"
"For some use patterns, reducing the effective boom length to less th
length may further reduce drift without reducing swath width."
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"APPLICATION HEIGHT"
"Applications should not be made at a height greater than 10 feet ab
unless a greater height is required for aircraft safety. Making applic
safe reduces exposure of droplets to evaporation and wind."
Is
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"SWATH ADJUSTMENT'
"When applications are made with a crosswind, the swath will be displaced downward. Therefore,
on the up and downwind edges of the field, the applicator must compensate for this displacement b
adjustuig the path of the aircraft upwind. Swath adjustment distance should increase, with
uicreasing drift potential (higher wind, smaller drops, etc.)"
"3
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"TEMPERATURE AND HUMIDITY "
"When making applications in low relative humidity, set up equipment to produce larger droplets t
compensate for evaporation. Droplet evaporation is most severe when conditions are both hot and
dry."
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Summary of Required Labeling Changes f










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"SENSITIVE AREAS"
"The pesticide should only be applied when the potential for drift t
residential areas, bodies of water, known habitat for threatened or i
crops) is minimal (e.g. when wind is blowing away from the sensit
^
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"Do not apply this product with aerial or chemigation equipment"
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"Do not apply this product to seeds or seed pieces."
S « §>
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For foliar applications:
"The maximum application rate for almonds is 4.5 Ib ai/acre, with
rate of 20 Ib ai/acre per crop cycle*. Preharvest interval (PHI) = 3(
Interval is 24 hours. Almond hulls may be fed to livestock."
"The maximum application rate for apples is 4 Ib ai/acre, with a m
of 32 Ib ai/acre per crop cycle*. Preharvest interval (PHI) = 0 days
Interval is 24 hours"
"The maximum application rate for apricots is 2.5 Ib ai/acre, with i
rate of 12.5 Ib ai/acre per crop cycle*. Preharvest interval (PHI) = I
Interval is 24 hours"
"The maximum application rate for blueberries is 2.5 Ib ai/acre, wi
application rate of 35 Ib ai/acre per crop cycle*. Preharvest interva
Restricted Entry Interval is 72 hours"
"The maximum application rate for cherries is 2 Ib ai/acre, with a r
rateof!41b ai/acre per crop cycle*. Preharvest interval (PHI) = 0
Interval is 24 hours"

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Summary of Required Labeling











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seed treatments:
Ifa, clover, lespedeza, or trefoil seeds
Si
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r slurry seed treatments use 4 ounce ai/100 Ib seed."
r dust seed treatments use 6 ounce ai/100 Ib seed."
r planter box seed treatments use 0.25 ounce ai/100 1
o o o
























Ł
ey seeds
r slurry seed treatments use 1.5 ounce ai/100 Ib seed.
!Ł






















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r dust seed treatments use 1.5 ounce ai/100 Ib seed."
r planter box seed treatments use 0.8 ounce ai/100 Ib
o o
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i seeds
r slurry seed treatments use 1.3 ounce ai/100 Ib seed.
: dust seed treatments use 1.9 ounce ai/100 Ib seed."
• planter box seed treatments use 0.25 ounce ai/100 1
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s (table) seeds
• slurry seed treatments use 6 ounce ai/100 Ib seed."
• dust seed treatments use 9 ounce ai/100 Ib seed."
o o o
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„
grass seeds
• slurry seed treatments use 4.1 ounce ai/100 Ib seed;
• dust seed treatments use 6 ounce ai/100 Ib seed."
S s s
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coli, Brussel sprouts, cabbage, and cauliflower seeds
slurry seed treatments use 1.1 ounce ai/100 Ib seed.'
dust seed treatments use 1.1 ounce ai/100 Ib seed."
planter box seed treatments use 0.25 ounce ai/100 11
CJ »•* t-» J-t
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n
)t seeds
slurry seed treatments use 4.4 ounce ai/100 Ib seed.'
dust seed treatments use 6.75 ounce ai/100 Ib seed."
ESS
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seeds
6 ounce ai/100 Ib seed."
5 ounce ai/100 Ib seed."
use 0.5 ounce ai/100 Ib s
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cantaloupe, cucumber, or tomal
"For slurry seed treatments use
"For dust seed treatments use 2
"For planter box seed treatmen











Sounceai/lOOlbseed."
o
collards or kale seeds
"For slurry seed treatments use











1 ounce ai/100 Ib seed."
ounce ai/100 Ib seed."
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corn (field) seeds
"For slurry seed treatments use
"For dust seed treatments use 1









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ounce ai/100 Ib seed."
unce ai/100 Ib seed."
use 1 ounce ai/100 Ib see
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corn (sweet) seeds
"For slurry seed treatments use
"For dust seed treatments use 2
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5 ounce ai/100 Ib seed."
ounce ai/100 Ib seed."
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cottonseeds (acid delinted)
"For slurry seed treatments use
"For dust seed treatments use 1










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25 ounce ai/100 Ib seed.
5 ounce ai/100 Ib seed."
CS «N
cottonseeds (machine delinted)
"For slurry seed treatments use
"For dust seed treatments use 2











5 ounce ai/100 Ib seed."
5 ounce ai/100 Ib seed."
m c^
cottonseeds (fuzzy)
"For slurry seed treatments use
"For dust seed treatments use 2











13
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cowpeas
"For slurry seed treatments use 1.5 ounce ai/100 Ib seed."
"For dust seed treatments use 2.25 ounce ai/100 Ib seed."
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eggplant seeds
"For slurry seed treatments use 2.7 ounce ai/100 Ib seed."
"For dust seed treatments use 4.5 ounce ai/100 Ib seed."








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flax seeds
"For slurry seed treatments use 2 ounce ai/100 Ib seed."
"For dust seed treatments use 2.6 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.25 ounce ai/100 Ib sc
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"For dust seed treatments use 9 ounce ai/1 00 Ib seed."
















mustard or rape seeds
"For slurry seed treatments use O.Sounce ai/100 Ib seed."















"d
oat seeds
"For slurry seed treatments use 2ounce ai/100 Ib seed."
"For dust seed treatments use 2 ounce ai/100 Ib seed."
"For planter box seed treatments use 0.8 ounce ai/100 Ib see















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okra seeds
"For planter box seed treatments use 0.5 ounce ai/100 Ib see<















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onion seeds
"For pelleting, use 0.8 pound ai/ Ib seed."
"For seeder box seed treatments use 0.75 pound ai/3 Ib seed.
















peanut seeds
"For slurry seed treatments use 3 ounce ai/100 Ib seed."









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pea seeds
"For slurry seed treatments use 1,


„
1
ounce ai/100 Ib seed."
use 0.5 ounce ai/100 Ib s
"For dust seed treatments use 1 .9
"For planter box seed treatments




.5 ounce ai/100 Ib seed."
5 ounce ai/100 Ib seed."
pepper seeds
"For slurry seed treatments use 1,
For dust seed treatments use 2.2!



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potato seed pieces
"For dust seed piece treatments u




.1 ounce ai/100 Ib seed."
radish seeds
"For slurry seed treatments use 1


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"For planter box seed treatments




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ounce ai/100 Ib seed."
rutabaga seeds
"For slurry seed treatments use 2
"For dust seed treatments use 3.4
-

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"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are (registrant inserts conect c
resistant materials). If you want more options, follow the insfructions for category [insei
A,B,C,D,E,F,G,or H] on an EPA chemical-resistance category selection chart."
All mixers, loaders, applicators, and other handlers (including handlers participating in
transplanting as part of root dip treatments) must wear:
- long-sleeved shirt and long pants,
- shoes plus socks.
- chemical resistant gloves (except for applicators driving motorized equipment)
- chemical resistant apron when participating in dip treatments.
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"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are
materials). If you want more options, follow the instructions
H] on an EPA chemical-resistance category selection chart."
All mixers, loaders, applicators and other handlers (including
transplanting as part of greenhouse-soil treatments) must wea
- long-sleeved shirt and long pants
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approved respirator with any N2, R, P, or HE filter


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Some materials that are chemical-resistant to this product are
you want more options, follow the instructions for category [ii
EPA chemical-resistance category selection chart."
"All mixers, loaders, applicators and other handlers must wea
- Long-sleeved shirt and long pants,
- chemical resistant gloves,
- shoes plus socks,
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approved respirator with any N2, R, P, or HE filter."
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"User Safety Recommendations"
"Users should wash hands before eating, drinking, chewing gum, usi:
"Users should remove clothing/PPE immediately if pesticide gets ins
put on clean clothing."
"Users should remove PPE immediately after handling this product.
before removing. As soon as possible, wash thoroughly and change i


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"Post-Application/Entry Restrictions:
~ For applications to ornamentals at non-commercial sites and golf-c
allow others to enter until sprays have dried."
~ For applications to seeds: All persons handling unbagged treated s
personal protective equipment required on this labeling for handlers.
~ For post-application fruit dips: Do not contact or allow others to co
sprays have dried."
&
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protective equipment required on this it


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"Seed that has been treated with this pn
distribution must contain the following
This bag contains seed treated with capl
this bag to load the treated seed, wear It
resistant gloves, NIOSH-approved dust-
MSHA/NIOSH approval number prefix
or HE filter) and eye protection."
"Labels attached to treated bags of seed
Purposes'."

CO
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protection."
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plus socks, chemical-resistant gloves, N
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"Do not apply this product in a way tha
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ator with any N2, R, P,
S^ rn ,*^
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45 ^ to ±:
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"This product cannot be added to paint or adhesive ]
label contains the following statements:"
"When using this product, wear long-sleeved shirt a
sprayer, water-proof gloves and a NIOSH-approved
approval number prefix TC-21C) or a NIOSH appro
must also be used."
CO
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For seed treatment rates: see Occupational Use (WP!
For application rates also see Products Intended Prin
section


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drift. Keep people and pets out of the area during ap


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Application R
for products a]
liquid sprays (
equipment)

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use on ornamentals as a root dip:
lea, carnation, chrysanthemum: 0.3 ounce ai/gallon
use on gladiolus corms: 0.3 ounce ai/gallon
use on tuberous begonia: 1 .2 ounce ai/gallon
use on azalea, carnation, chrysanthemum, and roses:
use as a seed treatment:
is, cabbage, com, melons, peas, squash: 0.02 ounce ai/pi
s, Swiss chard: 0.08 ounce ai/pound seeds
ach: 0.04 ounce ai/pound seeds
post-harvest use on apple and peach trees and grapes
t. C3 fc. I. t, i. = •Ł C b.i
o J3 ,o o o o S S •§, o :
fc. < fe b to tojaj^Lo toi.

Ł3 •
o ;;

n '
_O 1

1 '
P i1
S t
.S tn
II i
                                                                                                                                            	II	I	
                                ',:!'{	R  !ii	!•	III.)	l«	11	lill'i	nil	I1:-'	lilt	1	li.;	^
                               	Ill	Ill	II	llilllilli  iilifll	I	I	Ill	I"!	I	I	    Ill	
 ii"	il'i'ii	'A!	i'!	!	llli	.ill	'!	             	i	1!!!!M	1 Bfl	Sii	i:'n	I!	t	I1!:1!!1}

iHI	Ill	li'll	    	Ilii!  i'              	li,li( illp  	Ill	I	Ill I lilillil	Pi"!	I'lii'l1  	Iliilliil',1  IIJ " ml'  I   Jiil1	lllllllllliiilllll	llll|jil i	Ill  ill'liill11!!
 	l	i	
 m  ii  ,1  ii   til 111 ii iiiiiiiiii  in    i iii  i	i ii iiiiiiii 11 iiiiiliiiii in ii i  i iiiiiiiiiiiiiiiiiiiiii ii PI iiiiiiiiiiiiiiiii iiiiiiiii	in»in iiiii iiiiiiii	in  iiiiiii   iiiiiiiiiiiiiiiiiii i •
                                                                                                                                                                  iiiiiviiiiivi U ii in i ii i

-------
       C.     Existing Stocks

       Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Reregistration Eligibility Decision (RED). Persons
other than the registrant may generally distribute or sell such products for 50 months from the
date of the issuance of this RED. However, existing stocks time frames will be established
case-by-case, depending on the number of products involved, the number of label changes, and
other factors. Refer to."Existing Stocks of Pesticide Products; Statement of Policy"; Federal
Register. Volume 56, No. 123, June 26, 1991.

  The Agency has determined that registrants may distribute and sell captan products bearing old
labels/labeling for 26 months from the date of issuance of this RED. Persons other than the
registrant may  distribute or sell such products for 50 months from the date of the issuance of this
RED. Registrants and persons other than registrants remain obligated to meet pre-existing
Agency imposed label changes and existing stocks requirements applicable to products they sell or
distribute.
                                          109


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VL  APPENDICES
       111

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                                                                                                                                                                  :iliIIIW   	I!1'!,,,1"! "liPJ'llii.iilillllUlllllllP1 'ii*!'  :ili!IIIHIPi:"l|i||||||||iilF!PPF1!:!' I  "	Mil I'll'iiiPFIJIIilliPiiiilliililillPF.iaPLIfFillllllllllllilU IllllllllllllllllilllllPlliiiikillll,"11"!!1
               l:f!<*i!'HFi!Łi§l^l!iL!'J!if:  il!!!!!'1^
Bii	B^^^^^^^^^^^^^^^^^^^^^^^^^^	H                                              	jSi"<	*»	KM	-	-	*	-i:-	'
                                                                                                                                                                                                  	I!	^^^
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                                                                                                                                                                                                                              i	liii I

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                                                                       lllllllill|ii'rii|||||llllllillllllllkiii!|lillllllllllllLi .'"i iBi'llllF ...'"PI1,,	I:  !  ii!  I, 	lllilPI'll1 jllliTllhillllll!: lii  IIIIPliiIlP111'11 LllJi: i	ililml	llllLllfit'.H^JIPWlill IIIJllllllPlllilV"' in 1llllllllll|!llllliii ir Ulliiiifliliiili ,i  nlKllllllni f"  "LWiml '.I'jilW'1 i.il!•'!".,111


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                                                                                    /siiiiEiii ' '•'' IK : .r11 'ill11 '"'fii ii iiLi|l:'iiiii:[ n'n
                                                                                                                                                                               liiiiiiiiiiliinir ' iK'iH
1,	
                                                                                                                                                 iH^^
                                                     'i'ltM^                                                                    	liEiljii	JJB^^^^^^^^^^^^                                IHflJjf MiK"1*	'i'-'	i!!i|l>:VS^^                      1
ligiiiiiiin^^^^^^^^^^      	''Lii	1'iiiiv                                                               	iiiiiiira^                                                                              	9?!;,:^
                                                                                      	•	,	i	'	
                                                                                                                                                                     ,  ,|i :

-------
             APPENDIX A - Table of Use Patterns Subject to Reregistration

  Appendix is over 80 pages long and is not being included in the RED. Copies of Appendix A
are available upon request as per the instructions in Appendix E.
                                       113

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                   i"!>ii::ii:iii|!iii!iiPiil«iilP!li|pPPP!!:iP!l!:iiMP;!;!i:i|i' ISillillilPPIIIPPPIilillillili'iPPIIillPPPIIIIPlllIPP!11 "IjilPDl'PPPII	J'liUIPPPPPPPli;'!	t	1!IPPIlPPPjiiiijPlli^PI111,! JUVRJi:," TOMEIjllVfliiJIiilNiiii!!,HH'i	!!!""lllilli	i	Hi	PuiimP1'Ł'IP 'MXAniiljiPPlPltiPPPPUPPPSl! ,<' iPPPllPPII'liiiN'1 fVllllIPPIOPIPPPlliiiliiXii.i'liPlliPlllPPPPiiPII • IVIvtiii!ill':Sillllil!	«" Hit	I'illliifTOflDf Ililll	I"!!	k'.JillUK!!PPIliPPPiiPii«iiliP«PPI«PPPI!hll!i!ln«i]:Pllli,ii!: i,!:!,P



                                                                                                                                           ;, ,ip^                                                                 	i
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                            j^^                                 	IIH^^^^^	jiiK                                  	%iiimiwfc&	mmut	ii	^m'ftiMa	                                             I

                                                   1/lilllH^^	l1tf,l!IklI![I''!.ll|Tirjj|H';, -i hfjMiratilifM	:j^'!liiii|W^                       	                                      I
                                                                                                                                          "	'""	' 2 ."""I, I'."' "1 !„""","	,	I"""""!	'. I'"!,! 1!" J""'!'™!-'"	'!"'"'
                                                               ijiiiiiiiiilii11 '"ijiiii1! iiiiiii,.fliiiiiiiiiiiiiiii .fiiiiiiiiiiniii1:"iiiiiiiiiiiiiinii 'i"i iiiiiiii'i'iiiii'ii •'"  r iiiiiiiiiinii IPiiiiiiin:flimn „ iniiiiuinNniiiiiiiiiiiiiiiiiiiniiiiiiiiliiiiik,,,'iihHiii,':nimi>"   ' 

DIHM^^ ' iiiiin : in ,,!iiiiiii;:iSiH \ HiiiiiiiiuMiiiiiiyii, iiiiiiiiiiiiH 'a i:iiiiiiiiiiiiiiiiF!iii:iiii ^^ iB^^^^^^^^^^^^^^ 'iillli: iii1^^^ ilin^^^^^^^^^^


-------
                                GUIDE TO APPENDIX B
 Appendix B contains listings of data requirements which support the reregistration for active
 ingredients within the case number 0120 covered by this Reregistration Eligibility Decision
 Document. It contains generic data requirements that apply to captan in all products, including
 data requirements for which a "typical formulation" is the test substance.

  The data table is organized in the following format:

  1. Data Requirement fColumn 1). The data requirements are listed in the order in which they
 appear in 40 CFR Part 158. the reference numbers  accompanying each test refer to the test
 protocols set in the Pesticide Assessment Guidelines, which are available from the National
 Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 605-6000.

  2. Use Pattern (Column 2).  This column indicates the use patterns for which the data
 requirements apply. The following letter designations are used for the given use patterns:
  A     Terrestrial food
  B     Terrestrial feed
  C     Terrestrial non-food
  D     Aquatic food
  E     Aquatic non-food outdoor
  F      Aquatic non-food industrial
  G     Aquatic non-food residential
  H     Greenhouse food
  I       Greenhouse non-food
  J       Forestry
  K     Residential
  L      Indoor food
  M     Indoor non-food
  N     Indoor medical
  O     Indoor residential

  3- Bibliographic citation CColumn 3). If the Agency has acceptable data in its files, this column
lists the identifying number of each study. This normally is the Master Record Identification
(MRID) number, but may be a "GS" number if no MRID number has been assigned.  Refer to the
Bibliography appendix for a complete citation of the study
                                          115

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            :  p"    "  ;'  J- •,.*:,!.    !  : t   ,;:'  :.
                                                                         iiii iiniJiii , a^. ..... ', :f in. iiui lij'iiifi ..... "'jiiiiiiiiliyf iiiiiiiiiiiiin i; I ;i ,;' JT";-:;* • .i1'1 i a; • wr , n,!, , ..... J: < iM . tnu- w iiniii1 I, i rl'iviiiiiiiiiiiiil'iL iiiiilllii::': liiiiiiiiiiikn :
                             ii jiiiinii • 'JaiiiFfci1!1 1 'll >:
                           . ' ....... ' If 'I ' ; ;i
iiii!, i'liiiiiiin ..... ijiiiiiiB^^^^^^^        ii aiiiiii ..... iiiiiiOiiiiii ..... i1 jiii • j< "iisiHtr iir" "i n ..... air. 'iiniiinii.!] iii'!!"' •' K», '>' in .......... !< i,i  i :, ....... IK!1 < ...... < , ;,iiiiwK^^ ..... iii> ...... 'i:::!! ...... tiiiiiaiiiij ....... nil v^^   "awni ........ >!:!»> fif
                , aillllt1 1 ' liilllll iHIF : ....... L ^V?. "' " life: iiJlill ' It,; if , !i ! ...... •; illlKi'.:!' : ' ji ..... i! ' > I ..... It I'vU) ...... 1 ..... iliiii-fillll K11»^^^^^^^^^         3' H1;
                                                                                                   iii ..... pi, ;,i ....... , li1 ], v
                                                                          ..... > ...... ' i Jtniin
                                                                            t\ <;at

                                                                                                                          ..........
                                                                                                                        sf;aii |
IllW^^^^^^^^^    	illxi'd^      	'	:%^^^^^           	::!liill!!i:|lp!lllW	illin^^^^^^^^^^^^^^  	it	l^il^CK^^^^            •'	"ill	IIIIR^^^                             	flilW^^
                                     ijiiiiK li	liiH^^                	iiiiiiiM^^^^^^^                   	iai^^

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Data Supporting Guideline Requirements for the Reregistration of Caotan
REQUIREMENT USE
PATTERN
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Vapor Pressure N/A
Dissociation Constant N/A
Octanol/Water Partition All
pH All
Stability All
Oxidizing/Reducing/Action All
Flammability N/A
Explodability All
Storage Stability All
Viscosity N/A
Miscibility N/A
Corrosion Characteristics All
Makhteshim-Agan of North America
11678-1
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
Chemical Identity All
Start, Mat, & Mnfg. Process All
Formation of Impurities All
Preliminary Analysis All
Certification of limits All
Analytical Method All
Color N/A
Physical State N/A
Odor N/A
Melting Point All
Boiling Point N/A
Density All
CITATION(S)
N/A
N/A
40021201
40021202,40231801
40021202,40231801
DATA GAP FOR MUP
N/A
DATA GAP FOR MUP ONLY
DATA GAP FOR MUP ONLY
N/A
N/A
DATA GAP FOR MUP ONLY
CSF
40121701,40231301
40121701
40021201
CSF
40021201
N/A
N/A
N/A
40231201
N/A
40231201
                              117

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               Data Supporting Guideline Requirements for the Reregistration of Captan
                                            USE
                                          PATTERN
                                                                                CITATION(S)
   ::	:	:.	:.	.::	:	63-8
              Solubility
           , ............................ Vapor Pressure
                                      1! lifmOi'l ..... lull' ..... I: JlilllH^^^ '
                             All
                             	ma
                             N/A
                                                                       	I!	
                                                              1'<;i!l!^!!lllllllllillllll!!!il!;j:l!ii;;i lilli;!.;^^             "
                                                                                     40231201
                                                                                         N/A
                                        T11 thMJIn'llll:!:1'! fllllll ..... jiyililfllliilP'iJe'lluiillUi"'11; ^iiliriLailil
                                                                                       illihiliUlikllBIIB^JllPlililllllllllli!1!,!
                                                                                         N/A
              Dissociation	Constant	
              1H                           	1M^^^	timtiliS	«B,"ftl»n	iiX^^^^^^^	H	!	liPI	i	
              Octanol/Water Partition         AU                           40021202

i=^^   	'	'	j>iT"''	"ji^	""""'T"'..."~."'	""	,J^,,!""	II"	I	""'	"	ll,",,,°T"	7,1"',^	I	11"^?^'

                                          	A!'	"'	""	'	'	46231251"'
                                          	;	;	;	|	;	;	j	;	[	;	    	    ,,
                                          	AU	  DATA GAP
                                    I:'1!!!	illlllH	F •hiYrilliUNN	ill1:!, f!H\	)
"i	•' II
     	;	i;	:	163-16
              Ixplodability
                -18
	mm	i	IIH^^^^            	in^^^^^^^^^^^^^             	I^.IJIIK
lammabUity                   N/A

                	""	'	'	"""	AU	"	''	'	'"

                             AU

                             N/A

                        	N/A	
                                                                                           A
             	Storage Stability
              ' ,f!li|'         ' '''  '!"
             	Viscosity

              Miscibility
                                                                   DATA GAP FOR MUP ONLY

                                                                   DATA GAP FOR MUP ONLY
                                                                                         N/A
              63-20      Corrosion Characteristics
                                            AU

                                                                   DATA GAP FOR MUP ONLY
              Drexel Chemical Company
              19713-258


              REFS lists this as a formulation intermediate, will be
              addressed in Product DCI


                    '''I^IImm,,, Dietary	-	Quail
                                         ABCHIKL
                                            M
                                                                                 ,01,00020560,


                                                                  00022923,00104686,43869802
i^SSSS ...... ^ ..... ;;::;l=::f 1-2B     ..Avian Dietary - Duck
                                         ABCHIKL
                                                                            00022923, 43869803

                                             .!n:!liR^^^^^^^^^^^^^

           i	
iiiiiiv^^^^^^^  	iiuiiiiiiiii1: iniiiiiiiiniB^^^	,	II;M	IIIK
                                       ..... I* >• ....... l
                                                                                        ....... iw: .....        I
                    ,	t	"I

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  Data Supporting Guideline Requirements for the Reregistration of Captan
 REQUIREMENT                        USE                     CITATION(S)
                             USE
                           PATTERN
 71-4A
 71-4B
 72-1A

 72-1B
 72-1C
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicity BluegiU
Fish Toxicity Rainbow
Trout
  ABCK
  ABCK
ABCfflKL
   M
Fish Toxicity BluegiU (TEP)    ABCK
ABCfflKL
   M
                    00098295
           00098296, 00104083
GS0120042, 05020144, 00057846

                    WAIVED
                    00057846
72-1D      Fish Toxicity Rainbow
           Trout (TEP)
           Fish Toxicty Rainbow Trout
           (THPI)
           Fish Toxicity Rainbow
           Trout (THPAm)

72-2 A      Invertebrate Toxicity

72-3A      Estuarine/Marine Toxicity -
           Fish
72-3B      Estuarine/Marine Toxicity -
           Mollusk
72-3C      Estuarine/Marine Toxicity -
           Shrimp
72-4A      Early Life Stage Fish
72-4B      Life Cycle Invertebrate
72-5       Life Cycle Fish
122-1A     Seed Germination/Seedling
           Emergence
122-1B     Vegetative Vigor
                           ABCK                        WAIVED
                           ABCK                        43869806
                                                         44738801
                         ABCHIKL    00070751, GS0120041, 00002875,
                             M              '            43869807
                           ABCK

                           ABCK

                           ABCK

                           ABCK
                           ABCK
                           ABCK
                           ABCK

                           ABCK
                               44806504

                             DATA GAP

                               44806503

                               00057846
                               44148801
                               00057846
                               WAIVED

                               WAIVED
                                   119

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                                                                                             	i	I	Ill
               Data Supporting Guideline Requirements for the Reregistration of Captan
        !	':'1I	illiilliii
I         '''i	tf
                                                          USE
                                                 	i	,,	,	PATTERN
                                                          —
                                                                                    CITATION(S)
            	,	141=1,
                """	Xqna&cTiant	Srowth	'	'""	'	ABC"K	
                "Honey Bee'Acute	Contact	^g^g	
                                                                               •IIU    H\ rill111
                                                                                          05001991	
     i	••-'.	:'i	'•	TOXICOLOGY
                                                                             :!'	ol^^CTA^A1	GAP'1'
                         .Acute,Oral Tpxicity - Rat
      ilffl
   i	'81-3	

     81-4

     81-5

     81-6
     I	Ill11,1	
Acute Inhalation Toxicity -
Rat

Primary Eye Irritation -
Rabbit

Primary Dermal Irritation -
Rabbit

Dermal Sensitization -
Guinea Pig
(• 'iii1'!1 (	uiii1 ii iiiiii  ii I in 11  I   M nn i
                                                        ACHIL	55148375"	50086588,'DATA'TjAP	
                                                        ACHIL
                                                        ACHIL
                                                        ACHIL
                                                                                         00128621
                                                                                         40021401
                                                                                         00054791
                                                                   iillllllillllililil I II in Hi II
                                                                                    	nil i  ji
      i iii in in  III
                           Acute Neurotoxicity - rat

               82-1A      90-Day Feeding - Rodent
       iiiiiii	i iliiiiiiiii"wiiifiili[iiiiiii i iiiiiii in ii  iiiiiii in i  \\J       °
   „•„!!!	"I,	•!!	!,„82-1B   „;   90-Day Feeding - Non-
   •"	•	••	i	••	'	-	- •	rbdent
                                                         AH


                                                         AH
                          21-Day Dermal - Rabbit/Rat    ACHIL
                                                                                44041501

                                                             00120316, 00129163, 00129164,
                                                                                00129157

                                                                                40893604
                                                                                          40273201
                                 Inhalation - Rat
                                  iiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiii ..... i in i   iiiiiiii
                 90-Day
                       J	
      82-7       Subchronic Neurotoxicity -
"iniii	:nsiH	•	"	
	i	:	:	rat
                                  :>'': i!iii|M,'i i inn nn linn n n inn nn n n
                              ACHIL                           41234402
                               i in i "i iii in in i in i ill (iii hi i ,i 1,1 in i in,	n i „ i ii, i iii    11 i  in	),i^
                                                                44041502
                               w MniivinnniUiii1	iiiiiniiiiiii'iiiiiiiiFiiiiiihii.'iiriiiriiiiiiiiiiriiiiiijliiiiiiiiiiiiiiiiiiiiiiiiMn v 'tff <:.iiiii»in|igioin||[iiiinni,i...i' III«HII	:":•». n1 inniiin inn 11   n iniiinnn  innninniinn nn nn inniiiinnnnnni
                                                                                                     in in |
            III,	ChronicFeeding Toxicity -
            ^S	Rodent
=ssrar:s;;j!	I1=I1;T	,	  Chronic Feeding Toxicity -
^!!                        Non-Rodent

                       '   Oncogenicity - Rat
                                AH


                                AH


                                AH
                                                                     00120316,00129163,00129164,
                                                                                         00129157
                                                                                                 I
                                                                                          40893604
                                                                      00120316, 00129163, 00129164,
                                                                                00153207, 00129157
                                                     120

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  Data Supporting Guideline Requirements for the Reregistration of Captan
 REQUIREMENT
                                         USE
                                      PATTERN
                                                      CITATION(S)
 83-2B      Oncogenicity - Mouse

 83-3A      Developmental Toxicity -
           Hamster
83-3B

83-4

84-2A
84-2B

84-4
85-1

85-2
           Developmental Toxicity -
           Rabbit
           2-Generation Reproduction
           -Rat
                              AH

                              AH

                              AH

                              AH
           Gene Mutation (Ames Test)    ACHIL
                                       ACHIL
Structural Chromosomal
Aberration
Other Genotoxic Effects
General Metabolism

Dermal Penetration
                                       ACHIL
                                        AH

                                       ACHIL
  1977 NCI STUDY, 00068076,
                   00126845
         00078623, 00086803

         00093883,41826901

         00120315, 00125293

 00087805, 00131715, 00114210
         00131725,00131727

        00058608, 00098897
41505401, 41505402, 41505403,
                  41505404
                  00117083
OCCUPATIONAL/RESIDENTIAL EXPOSURE
132-1A     Foliar Residue Dissipation
 132-1B     Soil Residue Dissipation

133-3

133-4
           Dermal Passive Dosimetry
           Exposure
           Inhalation Passive
           Dosimetry Exposure
ENVIRONMENTAL FATE
161-1      Hydrolysis

161-2      Photodegradation - Water
161-3      Photodegradation - Soil
                             AC        40823902, 40966502, 40988601,
                                        40988602, 40988603, 40988604,
                                               43012903, DATA GAP
                             AC        40988601, 40988602, 40988603,
                                                 40988604, 40966502
                             AC        40988601, 40985601, 40966501,
                                               40966502, DATA GAP
                             AC        40988601, 40985601, 40966501,
                                                          40966502
                                     ABCDEFH     00096974, 40208101,41176301
                                         I
                                       ABC                 40208102,41176301
                                        A                  40658009,40658010
                                    121

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  I II ill IIIIII llllii  Illlllllllllllllllllll
                  Data Supporting Guideline Requirements for the Reregistration of Captan

              '"  REQXJIRliMENT                                 USE                  '	OTATKJNJS)'
                                                                      USE

                                                                   PATTERN
•    .....
                 "162-2
                              Aerobic Soil Metabolism         ABEFH

                              Anaerobic Soil Metabolism         A
                                                                                   ~ | ..... '," 00070414^ .......           ....... ' .................... ' .....

                  163-1
               11111111 111 III I ill III 111 11 I INI
                                                                                        00098881, 40658008

                                                                                                   40658011
                              Leaching/Adsorption/Desor     ABCEFH

                              ption

                  nyin iiliiiiini i nil in liiiiiini iiiiiiU^     niiiiiiiiiiiiiiiniiini ininlii n i nil i  ill i in nn in i  in in nn  in i i   nil              II
                  63-2        Volatility-Lab                     AE
                  Mi	I!" 411^^^    ill lilllli     ilKiill	Ilillllilil	hi	ll|	1	1	IK	i< I  ill '('( ' liliil "Bill ii 11"	I 'I! I! I!1!1 "I, i II	'III!" ,! llnllnlTBfi l,!li :i"l',' I	lil'lllllii
                164-1        Terrestrial Field Dissipation      ABH           40823901,40893601,40893602,

             ••in  i ! n '  linn1 iniiiiniiiiiii  ii iiliiii i i   inn 11 nil 111 iiiiinn  n i linn i in nil i  in  i   nn  in iiiinii ii n inn n  mi in nil n  n   11 nn n i in  iiiiininin ill  1111 BIB nil n in nil nn  in in i iiiiiiiiiiiinnii n iiiiini 40893o03«
                                                                                                             40231001
                                                                                                             lilllli  iiiiniiiiiiiiiiiinniiiiiiiiiiiiiniiiiiiiiiiini Illlllllllllllllllllll iiiii I
                                                                                                        111 ii  i  iiiiiii  11 ii ii i iiiiiiiiiii 1 ii iiiiiii liiiiiiiiiii inn I
                                                   111  i  nn 1 iiiiii 11 ii inn n  iiiiii nil n n   ii nn n i in iiinnin ii
                                                    in i n i  innii nnini iiiiiii I 11    iii n i nn inn nn  n inn Bin i i in i in in i
                  165-4
                              Accumulation in Fish
                                                                           40756601, 40756602, 40225601,

                                                                                       40225602,00160301
                     |-|	Drgglet Size Spectrum                     '     Satisfied by Spray | Drift Task Force
  B^^^^^^^	til
IB^^^^^	liJIIH	
  llllii	Illin^   •!;!"	Ill	lul!
                   Z-l	Drift	Fiejd	gvafuation,	,,;,	,_	;	,	(	,	„	gat:

                                          ilS^	                                                                            I
                                          STRY
                                              •IIIIW^^^^^	lipiMJVIIH^^	l||||llll	                          I

             I	:	lIMAIIi:	Nature	of Residue,,-, Plants	ABCH	;	00058941, 00083100, 00096978, _

                           i!^^                                                                00098831,00128355,

                                                                              	Mi.20=pJ)L	40658005,	40658006,	'	

                 ;;121r4B       Natureof Residue -               ABCH        00058940,00096901,00096908,

                                Livestock                                         00098786, 00128355,  00162723,

                                             M
                                             |^                                             	«Ł«MMM	«mi~—H
                                                                                        	IgfggyOi"	432-6g7-0~2
                                                                                                   •„? Z;
                              ',< 'niiiiiniiiiii'Miiinn.;!!'':,!!	iiniKiniAi/^^ 	11:1:11	iif pnn:	/'i,,' ,ir w^ippi' p	IFIIIPP; ' /UK ,'':: n	h,;",:!!
            ,
ng       iiiiiiR
                     ^^^^^^^^^    ii'iiiiiiiiiH:: iiiiiii'Tiiira^^^^^^^ iiiiiiiiiiiiu^^^^^^^^^^^^ ..... ii]iiEiiii>i«ii4 "! .it ."! ........ ..... i ...... ..... ' uiuiiiiiiiiiiiu'' : v -in { > ..... i ..... i> ..i!:"!, ' tiinti ..... IM, iiiwwiiJiiiiB^^^^^^^^^^^^^     jiijiliiiliiiri^^^^^^^^^^^^^^    n ...... in! /iiiiiiiiiiilLi'' ........ , jfti; ;»< > iiii'ii .....
                    ..... iiiiiiH^^^^^^^^^^      ...... iitiiiiiiiiii ...... BsiiiiW^^^^^^^^         ..... i ..... iij ..... , ..... 'ii inn ........ iii ....... iiftgiiviiL           ...... liiiJHi: ...... wviiiiii1'! ..... •iiiiH^  ..... B: ..... iii!^               ..... fti, iti ij.

                                  'riii'iiiiiiiLiiiiiiiiiiiiiiiiiiiiiniliiiiHr:!!
                                                             nni	ft /iiuin, rin11' 'iin Jiii!l!'TBih injiiiiiiiiiw 1
:,«!!•	:;ii	IIIIIIIIIIH^   	;
        nnwiiiip1
        iinp'ppi IP
        IB1!:!'11
                               Nil ..... illlH^^^^   ,I,,1II1|1|IK ,!l::i> 'illili1 „! «B ........ ..... Ii ..... „ '.Ili ........ llflllllllLill ilillllllllll,',; IIP ''I "Illlll- ' I' I, '* I ..... I IBIIll ..... UK ...... Iiill
                                                 ..... ly E; • , :> 'jriiiit fi™^                   ..... i
                                                                                                   'Jlillni!' liJPi'fJIlliliK	1	IIIihlfllHIipll	II
                                                                                             llllTlit.!:'!'!! Ł ....... I!' iliiilP!:1 ,::',i,,il,!lll:l I ' '!!• ill 1'
                                                                                         ^  ..... 11111 :ninn,iH         ..... NJI, ,
                                                                                	MH               	'iaiiiiHjii:v:i,,^^^^^^^         	
                                                                                                          	,HHI»^^^           	
         ••	IIS


         'IlllM     	JI!I0^^^^
                                 liaiKiW^^^^^^^^^^^^^^^^^       	fM	1V«^^^^^       	ir
                                                                                         ^^^^           	nriipiiiiiiniii1 will': L	n: iniiiiiiiiiiiiiiiiiiiii:'. u viiniiiiiini iv iiiiiiiiiiiinnii	in iiiiiiiih, ii<	i "ii
                                                               Si	                  '               	i.'''-:-'!^!!!!:!?:!:.!,;::::":
                              ]i rilllllllB^^^^	^iilllnyri ^  	plliplpllllll i'1 ^l!lnlini^
     IIH^^^^
                                 Illllli	IKS^^^^^^^^^^^^^^^^^^             	iiK^^^^^     	I	!iM^^^^                   	IliK^^^^^^^^^^^^^^^^^^^                   	m	JIIIM^^      	Wll-

-------
  Data Supporting Guideline Requirements for the Reregistration of Captan

 REQUIREMENT                         USE                      CITATIONfS)
  USE
PATTERN
 171-4C/D  Residue Analytical Method -    ABCH
           Plants and Animals
             00002927, 00002928, 00003025,
             00025123, 00025125, 00025129,
             00035246, 00035248, 00042645,
             00042646, 00045174, 00045175,
             00045176, 00045179, 00045182,
             00045183, 00045184, 00045188,
             00045189, 00053324, 00054015,
             00054016, 00070201, 00071790,
             00083393, 00085525, 00085526,
             00090988, 00090989, 00096910,
             00098726, 00098731, 00098747,
             00098751, 00098784, 00098789,
             00098804, 00098810, 00098811,
             00098817, 00098818, 00098894,
            00117087, 00128355, GS120-008,
            GS120-011,41393001,41386501,
                      41406901, 43548601
171-4E     Storage Stability


171-4 J     Magnitude of Residues -
           Meat/Milk/Poultry/Egg
171-4K     Crop Field Trials

           Root and Tuber Gronn
ABCH


ABCH
40752301, 41039101, 41557601,
         42803901, 43875603

00025125, 00035246, 00035248,
00045178, 00096910, 00098751,
00098808, 00098810, 00104753,
         40010501, 42296002
ABCH
           Beet roots
           Carrots
          Potatoes
            40189806, 41149104, 41306101,
                     41306102, 41468401

            40189806, 41149104, 41306101,
                     41306102, 41468401

            00098716, 00098894, 00054016,
            40189806,41149104,41306101,
                     41306102, 41468401
                                    123

-------
         Ill I  111 11
                                    i iiiiM i  nil ill in i in in in 11    i    i iiiiiii i
                                                                          nil in iiiiiii ill iiiiiii
                                                                                            1111  1 111 111 III i  l| 111 III III llli II III 111
jfijJSi	!!!•	        Data Supporting Guideline Requirements for the Reregistration of Captan
                                                                                            .                       ,

                  1IQUIREMENT                              _.^5__.                          CITATION(S)
                                                                      USE

                                                                   PATTERN
           llli	IIIIMIIB
                                        111	111	1 llli Mlllllii
                                                          111	(I IlllilNKiilliiil IIIIIIH
Iiiiiiiiiiiiiiiiiiiii ••	mm\M
   	                             Rutabagas
  ii in ill ill in iiii   1  iiiiiiliii •iiiiiiiii i iiiiiii i iiiiiiiiiiH Taro
 •III	I1IIIIH	ill ii i H     	1111|(l          	Ill IN	II	11


                                Turnip roots
                                                           lill
                                                                         iiiiiiiin	ii
Iilllllllllilllllllil

ii	11	ii in	
 40189806,41149104,41306101,

             41306102,41468401

 40189806,41149104, 41306101,

        lli'il'il'l'	 41306102, 41468401

                                                                                    40189806,41149104,41306101,

                                                                                                41306102, 41468401
 IIIIIIIIIIIII 111 IIIIIIIIIIIII  IIIIII II lilllll
lilllll IIII lilllll 11 III IIIIIIIII   llllllllll||lllllllllllll|ll

  Biiiiiiiiiniiiii||ini	i	iii'iii	iiiiiii iii	iiiiii
  in	iiiiiiliii	
                                Leaves of root and tuber         ABCH
                                iiii iiii^                 in iiii MI ii in 1111 iiiiiiiii  in i  iiiiiii in iiii 11  iiiiiiiiiiiiiiiiii    iiiiiii 11 ii  i iiiii   iiiiii iiiii i  iinii iiiiiiiiiiiiiiiiiiiii iiiiiiii
                                group
             	llli	iiiiiiiii'ii ii       in in	IK iiiiii 11	ii "i1 ii 
                                                                                     in iiiii iii i iM       iiiiiiiii  in iiiii ii HI iiiiiiiiiiiii iiiii n
                                                                                     40189806, 41149104, 41306101,
J41306102, 41468401
                                                                                                  flM
                                                                                     40189806, 41149104, 41306101,

                                                    II	I'111 I'll	I	I"	I	II!	Hlllllill	llli	IIIIIII	11111111	1	lii'illiUp	I  41306102, 41468401
                                                                    ABCH
                                                                                    00070201, 00159599, 40189821,

                                                                                    41149102, 41306101,41306102,

                                                                                                           41468401
  11111 in i ii iiiiiiiiiiiiiii i iiiiiiii
                                     iiiiiiiiiiiii i iiiiiiiiiiiiiiiiiiiii ill
                                                                        •iii 11 iii MI  11 iiiiiii
                                                                                                 •i n   iiiiiii ii iiiiiiii iiii i mi ii iiiii iiiiiiiiiiiii in in iiiii
Iilllllllllilllllllil IIIII
                 iiiiiiiiiiiiiii iiiiii i iiiiiiiii iiiiiiiiiiiiiiiiiiiii  iiiiiiiiiiiii  iiiiii iiiii 11 niiiiii iiiii    i  inn  iiiiiiliii iiiiiiiiiiiii i iiiii iiiiiiiii 11 1 ii iiiiiiiiiiiiiiiiii  11 iiiiiiiii iiiiiii iiiiiiiiiiiiiii iiiiiiiiiiiii 111 iiiiiiiiiiiiiiiiiiiii iiiiiiiiiiiii iii iiiiiiiiiiiiiiiiii   11 iiiiiiiii
                                I                                        II    t               "
 III III IIIIII IIII  IIIIIIIIIIIIIIIIII 1111  ililllH    	•lilllll	IIIIIIII     lilllll 11	Illlilllill^   i llll|i||||
 Iilllllllllilllllllil IIIIIIIIIIIIIIIIIIIII  I I  IIIIIIIIIIIIIIIB    IIIIIIIIIIIIIII I IIIIIIIIIIIIIII  I IIIIIIIIIIIII I IIIIIIII  IIIIIIIIIIIIIII IIIIIIII 11111111II III
                                                      lliillllllll iiiiiiiii IIII 1 111 III
                                                      11  i iiii in n in in in
                                                                                                    ii iiiiiiiii n  ni n in
                                                                                            i




                                                      	I''I	i	,	'	I	F	I'"'I	iiiTliii""'"i	1	1	11	'	i	I	"'	'"'i	"	1'I'iil	I	
                                                                         , ,        	 ill ,'  llli   n 111	     I"  		'I1	    "i

-------
 Data Supporting Guideline Requirements for the Reregistration of Captan

REQUIREMENT                          USE                      CITATION(S)
  USE
PATTERN
           Lettuce
           Spinach
           Brassica Leafy Vegetables      ABCH
           Group

           Broccoli
           Brussels sprouts


           Cabbage


           Cauliflower

           Collards


           Kale


           Mustard greens


           Legume Vegetables Group      ABCH
           Beans, dry



           Beans, succulent



           Peas, dry
             00070201, 00159605, 40189821,
             41149102, 41306101,41306102,
                               41468401
             00070201, 00159606,40189821,
             41149102, 41149103, 41306101,
                       41306102,41468401
             40189821, 41149102, 41306101,
                      41306102,41468401
             40189821, 41149102, 41306101,
                       41306102,41468401

             40189821, 41149102, 41306101,
                       41306102, 41468401

             40189821, 41149102,41306101,
                       41306102, 41468401
             40189821, 41149102, 41306101,
                       41306102, 41468401

             40189821, 41149102, 41306101,
                       41306102, 41468401

             40189821, 41149102, 41306101,
                       41306102, 41468401
             00046914, 00070201,
             40189820,41149101,
                      41306102,

             00046914, 00070201,
             40189820,41149101,
                      41306102,

             40189820,41149101,
                      41306102,
00098710,
41306101,
41468401
00098710,
41306101,
41468401
41306101,
41468401
                                    125


-------
 Data Supporting Guideline Requirements for the Reresistration of Cantan
REQUIREMENT
  USE
PATTERN
CITATION(S)
           Squash, winter


           Watermelons


           Pome fruits Group

           Apples
 ABCH
           Pears


           Stone fruits Group

           Apricots
           Cherries

           Nectarines
           Peaches


           Plums (fresh prunes)
           Small fruits and berries
           group

           Blackberries

           Blueberries


           Dewberries
           Grapes
          Raspberries
 ABCH
 ABCH
             00098818,40189820,41149101,
              41306101, 41306102,41468401
             OQ128355,40189820, 41149101,
             41306101,41306102,41468401
             00085526, 00098711, 00098722,
             00098789, 00106602, 00128355,
             00159597, 40189803, 40745403,
                      42252201, 42252202

             00070201, 00085526, 00098722,
             00106602, 00128355,40189815
                      00128355, 40189805

                      00128355,40189808

                      00128355,40189813

             00128355, 40189814, 40745406,
                               40745407

                      00128355, 40189816
             00046914, 00070201,
                      00128355,
             00046914, 00070201,
             00098726, 00128355,
             00162037,40189811,
                      40745405,
    42712801

   00090988,
   41039101
    42712801
   00090988,
   00159601,
   40189812,
   42254202
             00070201, 42712801, 4422201
                                   127

-------



               Data Supporting Guideline Requirements for the Reregistration of Captan
	gEQUlREMENT
                                                         USE
                                                      PATTERN
                                                          CITATION(S)
         jilji'fjiiii
                         Strawberries                              , 00046914, 00070201, 00090988,
         uii in  ipiiiiH  i  i ill 1 1 1" iiiiiii iiiiiib ii iiiiiiiii iiiiiiiiiiiiiiiiliiiiiiiiiiiiiiiiiiiiiiiii ....... ii'iiiiiiiiiiii ..... in11 mill .......... iiiiiii iiiiiii i ii ii i' 1 1 in in ii ill   ii'iiii ..... i        00117088  00128355 00159607
                                                               .....  [[[ ...................... '! 40745408*

[[[ Tree nuts group               ABCH

                         Almonds                                   00070201,00090988,00098804,
                                                                    00098811,00128355,00159596,
                                                                             ...... 401 89802, 40745402
                                                                    OQ070201, 00090988, 00098804,
                                                                      098811, 00128355, 00159596,
                                                                    00162037, 40|89802, 40745402
'iS^E?!^1' ..... !:™       ..... !:!: ..... !!™^^^^^^
!tC_ojrn2 sweet
                                                                    00003025, 00045176, 00070201,
                                                                    	~
                                 !i:"iiii[»i;iir ....... 1111111' f inn ..... • t ...... f iiit,, : »'''!', ri., jr.'1: ' w/iiii
                                                       ; ...... „ ..... •!."• j^m ...... \m,
                       RaffiH^jR;|Et«l[M,jJl	^M;|MHg^ll^^'a|BiJ451p3.,	41306101,	41306102,	
                       	™	F.	i^^          	iiiiiiiii^
                                      commodities
                                                                     '0002928, 00003025, 00070201,
                                                                   |OJ128355, GS120-039, 40189820,
                                                            :;i::::::^^^                   	^susio^	
                                                                                       41468401
J?!:o,Łe,S§Łd	Food
                                                       ABCH
                                           00098789, 00159597,42296003,

                                           oo"i28355"	SbTs^SoTir^fe^SB^
                                     uiii' aininiH" i	mi m: mam i i
             111 il	K1 ailll" IlliU'l" illli!
                                    	i IIIIU'T ".!!i w Jiimni"',, ,111, .ii
                                                                                        40189817
	.	»iiin	'	"	•••	•	'• •	in	••	'	MKHravra^	™=	

	!	'"	'	i!	S	!l	'!!!	!	,	'	'	II	I	 	I1'	I	"	I	I	I	I	!	I	I	"""	»	'•	I	I
!'	-	:	"	i	I	'Igg-1	!	Rotational	Crops	(Confined)	ABCH
                                                     41404001, 42378401
                                 M^^                  	Jlfc
                                 	'	
                                                                                     	NliiiiirB^^^

-------
3.
4.
                        GUIDE TO APPENDIX C

 CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
 considered relevant by EPA hi arriving at the positions and conclusions stated elsewhere
 in the Reregistration Eligibility Document. Primary sources for studies hi this
 bibliography have been the body of data submitted to EPA and its predecessor agencies
 in support of past regulatory decisions. Selections from other sources including the
 published literature, hi those instances where they have been considered, are included.

 UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
 case of published materials, this corresponds closely to an article. In the case of
 unpublished materials submitted to the Agency, the Agency has sought to identify
 documents at a level parallel to the published article from within the typically larger.
 volumes in which they were submitted. The resulting "studies" generally have a distinct
 title (or at least a single subject), can stand alone for purposes of review and can be
 described with a conventional bibliographic citation. The Agency has also attempted to
 unite basic documents and commentaries upon them, treating them as a single study.

 IDENTIFICATION OF ENTRIES.  The entries in this bibliography are sorted
 numerically by Master Record Identifier, or "MRID number". This  number is unique to
 the citation, and should be used whenever a specific reference is required. It is not
 related to the six-digit "Accession Number" which has been used to  identify volumes of
 submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases,
 entries added to the bibliography late hi the review may be preceded by a nine character
 temporary identifier.  These entries are listed after all MRID entries. This temporary
 identifying number is also to be used whenever specific reference is needed.

 FORM OF ENTRY.  In addition to the Master Record Identifier (MRID), each entry
 consists of a citation containing standard elements followed, hi the case of material
 submitted to EPA, by a description of the earliest known submission. Bibliographic
 conventions used reflect the standard of the American National Standards Institute
 (ANSI), expanded to provide for certain special needs.

 Author. Whenever the author could confidently be identified, the Agency has chosen to
 show a personal author. When no individual was identified, the Agency has shown an
 identifiable laboratory or testing facility as the author. When no author or laboratory
 could be identified, the Agency has shown the first submitter as the author.

Document date. The date of the study is taken directly from the document.  When the
date is followed by a question mark, the bibliographer has deduced the date from the
evidence contained in the document. When the date appears as (19??), the Agency was
unable to determine or estimate the date of the document.
                                         129

-------
	j	I!	

               •••ill II III I III IlllllllllllllllllllllllllllllmillIIIIIIliilliIIIIII

                 i n n nil iiiiiiiiiiiiiiiiii iiiiiiiiiiiini n n n i iiiiiiiiiiiiiiini n n i inniii|jgi iii ill 1 1 in ......  1 1 1 in i u i ,i 1 1 1 P i i inini!ii ••  i n PI n 11 1 1111 « in 111 wiiiiiiiiiiiiiiiiini iiiiiiinnpii i in 111 iiiiiiiiiiiiini 1 1 1 1 1 1 in 1 1, 111 1  i , iiiiiiiiiiiinini n n 1 1 11 iiiiiiiiiiini ill iiinii 1 1 1 1 1 1 ill n i iinn n i n i » iinniini »n ...... 1 1 1 1 iiiinnn 1 1 in • i  i , n 1 111111 i 1 1 in In in iiiinni 1 1 igiiii||n i in inn i in in n 1
                                                                                           11II 111 P 'I11111 II Hill il »l lllllii W^^   I1 I 11 I ill 'III 11 'III IIIIIIIIIIIIIIH^^   I Illlllllllllllllll

                                                                                           ,!"!	i "iBii"!	SViiiSB^  iiiiNKlB       ii!1,!1!!

                                                                                           • II Illlllllii ill IIII I II I illlllllliili Illlillli Mi  ill III IlillllPlI llllllliiUllillllllllllllllllllllll il|lli|i|ii
rr
           i5rkfii tŁ [[[ "Title. In some cases, it has been necessary for the Agency bibliographers to create or
           i mini i IP nnnnninii iiin in in m n iiiiiiiiiiiiiiii 1 1 inn iiiiiiin in niiiiiiiiniiiniiiHi: iiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiijiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiniin!, iiiiiiiiiiiiiriiiiiiiiiiiiiEiiiiiiiiiiiniiLiiiiiiPiiiiii ...... HP" .;„» iiiii!niiiiiii!iiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiii««        ...... A ...... i ........................................... , ................................................. &• ..... , ............................ s ............ .................... , ............. i ................. n,« .................. A ............... i ............................................. ................................... ....... ......................... ,»
                         enhance a document title.  Any such editorial insertions are contained between square
                         brackets.
       d.
                          .,.      ,   ...........   ,  ,            ,,   ,,      ., ..     ..  ,       , ,.
                          Trailing parentheses. For studies submitted to the Agency in the past, the trailing
                       ^^^^^^^                     ..... Łg ..... addffionto ...... any ..... self-explanatory text) me following elements
                          dgscribing the earliest known submission:
                            	Iiiiii                                                                            ilfilllH           I
           m	|:|"!"':""	*•* wfl"Frn	SublmiissibnclSel	The""date of the earliest known sutemssjon iappears
                                 ASministrative number. The next element .immediately following the word
       **,^i"!',5!!™-™** *5'*i!*^^r,"	OT^raeraduustotiyenumer_asspciatedwiie eariest known
                                 JEfulimiftter!^e'tlurcl e|ement is the submitter. When authorship is 3efault<
                                                    efeHenlis'
                                                                                                  "'•i|n s	ii"'	ui	u""'1'	a	'.	"	'	;;	
                                 Volume Idejitification Accession Numbers).  The final element in the trailing
                                 jpafenEeses identifies 3ie EP A accession number of Sie volume in which tlie
                                 original submission of the study appears.  The six-digit accession number follows
                                                   -,,	—gj^ gfan^s for "Company Data Library."	This accession

                                         is	in turn	followed^by an alphabetic suffix which shows the relative
                                                 study within'ffie	"	"	
                                                  "l
                  ^                         	ISH                                                          	                   I


                                                  ''     "	III" ",ll	I,* ,':IllftIliilllllllilTIl' illllllllillllpll	IWIIIIIIIIWilnll^^^^                	WllllllHIIII 1:V;:,;i:»^^^^      .........
                                                                           : Hi IIIIIIPPIIllllll!<,l,ll,"lll n !'i, UliiP"*!
                                                                                          • ..... I ......... •
                                                                                        , , | Hi " ' : ' :,|||, Pii[|i r
                                        ....... i ........ -inn^^^^^^^^^^^^^^^^   ...... < ...... m§m, ...... : .......... •
                                                                                                                        .......   I
                                                                        ,_	IIM	_r	i	,i:	i	i	'	



-------
                                 BIBLIOGRAPHY
 MRID
                   CITATION
 00002875
00002927
00002928
00003025
00020560
00022923
00025123
 Frear, D.E.H.; Boyd, J.E. (1967) Use of Daphnia magna for the microbioassay
 of pesticides: I. Development of standardized techniques for rearing Daphnia and
 preparation of dosage-mortality curves for pesticides. Journal of Economic
 Entomology. 60(5):1228-1236. (Also in unpublished submission received May
 11,1977 under 239-2458; submitted by Chevron Chemical Co., Richmond,
 Calif.; CDL:230225-A)

 Devine, J.M.; Morton, W.E. (1972) Determination of Captan
 N-Trichloromethyhnercapto-4-cyclohexene-l,2,-dicarboximidein Cottonseed:
 Report No. 120. (Unpublished study received on unknown date under OF0939;
 prepared by State Univ. College-Oswego, Lake Ontario Environmental
 Laboratory, submitted by Uniroyal Chemical, Bethany, Conn.; CDL:094582-A)

 Uniroyal Chemical (1972) Residues in PPM: Vitavax. (Unpublished study
 received on unknown date under OF0939; CDL:094582-B)

 Chevron Chemical Company (1977) Residue Chemistry Data to Support the
 Label Registration of Orthocide-Vitavax 20-20 Seed Protectant. Includes
 method RM-IF-1 dated Jun 25,1976 entitled: Determination of Captan residues
 in crops. (Unpublished study received May 11,1977 under 239-2458-
 CDL:230222-A)

 Schafer, E.W. (1972) The acute oral toxicity of 369 pesticidal, pharmaceutical
 and other chemicals to wild birds. Toxicology and Applied Pharmacology 21(?)
 :315-330.  (Also In unpublished submission received Apr 25, 1978 under 476-
 2180; submitted by Stauffer Chemical Co., Richmond, Calif.; CDL:233577-C)

 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary Toxicities of
 Environmental Pollutants to Birds: Special Scientific Report-Wildlife No. 191.
 (U.S. Dept. of the Interior, Fish and Wildlife Service, Patuxent Wildlife
 Research Center; unpublished report)

 Chevron Chemical Company (1979) Determination of Captafol, Captan, THPI,
 and 3-OH THPI in Tissues and Eggs and Determination of Captan, THPI, 3-OH
 THPI, and 5-OH THPI in Milk and Cream. Undated method nos. RM-6-G-2,
RM-1G-1 and RRC-75-32. (Unpublished study received Jan 2,1980 under
239-2211; prepared in cooperation with Stauffer Chemical Co.; CDL:099190-F)

                          131

-------
                                  inn in iiiiiiini i iiinnii ill nil in inn inn in n i in iiiiinn HI ill i HI in nun in iininnnnnni i ninnnnii ninnnninnnn niilinnn inn iiiiinin i iiiiiiiiiiiiiiiiiniii mi in in mi in in mi
         ill IIIIIIIIIIIIillli ll«           nil	Ill	Ill iilllililllliii i nil III ill III
                                             BIBLIOGRAPHY
            MRID
                                               CITATION
,,„,	_	^
	lillH in!	II
             	OggSgS	|eary» J-B-; Lai> J-c- (1976) Captan-Lactating Dairy Cow Feeding
             IB F'l'l	IH     tUi Study—Residues in Meat.  (Unpublished study received Jan 2,1980 under
                             239-2211; submitted by Chevron Chemical Co., Richmond, Calif.;
                             CDL:099190-H)

              00025129      Cheng, H.M. (1976) Metabolism of Carbonyl-14C-difolatan in Young Tomato
                             and Corn Plants. (Unpublished study received Jan 2,1980 under 239-2211;
                             submitted by Chevron Chemical Co., Richmond, Calif.; CDL: 099190-L)   •
                            	Pack,	D.E.	(1979) The Anaerobic Soil Metabolism	pŁCarbŁnjl-14C Cagtafpl.	|
                            	-j~p~5gs5egs|^12yreceivedJan2,1980'undier239-2211; submittedby'"'
^^
j||B^^^^^^^^^^	|(H
      -,-:-.; I=;00026453	
    iii	liiiii
                                                                              	m^:t
            00035246
                             HaumschildjD. •Wingender, TLJ. (1972) Report to American Seed Trade
                             Association, fnc.: Tissue Residue T  "  -   -        -^
                        I ^Crossbred Steers Fed Technical Captan: IBT No. J1255. Includes methods
                           entitled: Determination of Captan and Determinati
                           (THPI). (Unpublished study received Jun 27, 1977 under 3E1367; prepared by
                                                                                 Qiemical Co.,
                                                         s, Inc.,
                             Richmond, Calif; CDL:096174-A)
                           Taylor, R.E.; Brunhouse, E. (1972) Captan Study for American Seed Trade
                                                                       __.  __
                        -« .............. If1 including letter dated Feb 1, 1973 from J.C. Calandrato Ron Harris, received
                        •l^       1977 under 3E1367; prepared by Harris Laboratories, Inc., submitted by
                                 [[[ ninfn ............ n> .................................................. [[[ ....................... [[[ rm ............
            00042645
                             Rappaport, S.H.; Katague, D.B. (1978) Determination of Captan Residues in
                   1^^^^^^^^^^^   	•Łlpps by Gas |CjŁomatpgŁaphy. Metibpd RRC-76-3OR dated Mar 27,' 1978.
                   	sEed	stu3y	recelveH	Sep	25^	1980	
                                                                                          stauffer
                           Chemical Co., submitted by New Zealand, Ministry of Agriculture and Fisheries,
                          JW^
                                                                          il'IIL lililiL >!!,!!illllllllhl'iiilFliiiiilllllllfellllllllll 'I .iPli'JIlkillllli!!1! ill1', IfillB, IIV, i,lllP<'iliil III ''illlllilllllll'llllilllllilllllliKllli'lilllilllllllliiio ''llllllillllliilh.iilll
                                                                                                         I

-------
                                 BIBLIOGRAPHY
 MRID
                  CITATION
 00045174
 00045175
00045176
00045178
00045179
00045182
00045183
00045184
 Haumschild, D.; Wingender, R.J. (1972) Report to American Seed Trade
 Association, Inc.: Tissue Residue Study for Captan and Tetrahydrophthalimidein
 Crossbred Steers Fed Technical Captan: IBT No. J1255. Includes undated
 methods entitled: Determination of Captan and Determination of
 Tetrahydrophthalimide (THPI). Prepared by Industrial Bio-Test Laboratories,
 Inc. Unpublished study; 142 p.

 American Seed Trade Association, Incorporated (19??) Analytical Method Used
 for Residue Analysis of Captan. (Unpublished study received Mar 9,1967 under
 3E1367; CDL:096507-B)

 Wilson, M. (1973) Captan Residue Report: Field Corn Seed. (Unpublished
 study received on unknown date under 3E1367; submitted by American Seed
 Trade Association, Inc., Kalamazoo, Mich.; CDL: 096507-C)

 American Seed Trade Association, Incorporated (1973) Supplement to
 American Seed Trade Association, Inc. Petition # 3F1367 for a Captan
 Tolerance on Detreated Corn Seed Intended as Feed for Beef Cattle and Swine.
 (Unpublished study including letter dated Apr 25,1973 from J.C. McKay to
 Harold Wright, received on unknown date under 3E1367; CDL:096507-E)

 Patchett, G.G. (1973) Determination of Tetrahydrophthalamic acid Residues in
 Cattle and Hog Tissues.  Method no. WRC 73-38 dated May 17, 1973.
 (Unpublished study received on unknown date under 3E1367; prepared by
 Stauffer Chemical Co., submitted by American Seed Trade Association, Inc.,
 Kalamazoo, Mich.; CDL:096507-F)

 American Seed Trade Association, Incorporated (19??) Determination of Captan
 Residues on Treated Seed Corn. Undated method. (Unpublished study received
 Mar 9,  1967 under 3E1367; CDL:096507-J)

 American Seed Trade Association, Incorporated (19??) Method for
 Determination of Captan Residue on Corn. (Unpublished study received Mar 9,
 1967 under 3E1367; CDL:096507-K)

Kilgore, W.W.; Winterlin, W.; White, R. (1967) Gas chromatographic
determination of Captan residues.  Journal of Agricultural and Food Chemistry
 15(6):1035-1037. (Also In unpublished submission received on unknown date
                                        133

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                                                                            liii'iSTIJ1*
                           	:	:	BIBLIOGRAPHY

                                               CITATION
                                            SnutteH &^ American Seed Trade Association, Inc.,
            -iOp_04518_8       CJie;rcoji CJtemical Company (1972) Determination of Captan Residues in
                            r^^^^^ra^JM^P^^OE^^Miy	26j	1972!	'	^nj^tishecriEJdy	
                           	i received on unknown, date under 3_Elj367Ł submitted fey_ American Seed Trade
                                          	";	CDL:
                            D2043. (UnpublishedstudyreceivedMar•"9,1973
  •——^^':^^^;T-—-i-^-:T^:'^^dus1^alBio-Te^ Lab.oratories. Inc., submitted by American Seed Trade
;^~^HZ",'	Ill 111^
                                                                   iiIfliH^
                                                                   '
              00046914
                                                                                            ...... riiiiniiiliiH^        I
                                                                                                      illilllllllllll'llILiliiillill1 I
                  HensiU, G.S. (1957) Phaltan Research Report 1957. (Unpublished study
                            received pet 28,1957 under unknown admin, no.; submitted by Chevron
                       ,,	|	.j;CJ^m|caliiCo:2	Richmond,	Calif; CDL:! i9324-A)
                               ^^^jg^^y-Cnemicd Corjporation (1957) Methods of Residue Analysis of
                            '"Captan or pg1^^_  (DnpuDTlshed sm"5y received" Feb 11," 1958 under unknown
                            jadmin.no.; submitted by Chevron Chemical Co., Richmond, Calif ;
                           '                                   '       '        "
                                               ,               .        r   ,     |;,
                                        ^ Chemical Corporation (1 960) The Analysis ^Residues of            |
                                              .........                        ........     ......                 [[[
iliilililil'lllllllllllllilJlilllilll'l'nllnJllllll
                                   andPhtan
                                    ..... Ill, ...... |3, 1972 un3er 2^1215; submitted by Interregional Research
                                      ...... "4, ..... ISfew ..... B~runswick,'~NJ.;             "
                                                    ^^^^^^^^^^^^
                            UniYersity of Hawaii (1969) Captan-Taro Residue Study. (Unpublished study
                    =-^=^Ł=ieceiyed Jul	14,1972 under 2E1215; prepared by Agricultural Biochemistry
                    "•E'iiiE-I^Dept, Pesticide Laboratory in cooperation with Chevron Chemical Co.,
                            submitted by Interregional Research Project No. 4, New Brunswick, N.J.;
   00054789
l"]^^Zil^I~!!Il!!^ZZ."H	I~,~I~1~~~^~^",,~—II~Z,-L,	il.i -!~III	IJL	UlLZ'^iZ!!	~~~,1~~~~~^..
                        sliminary iToxicologicaiii |Study_ of S]Rr406, a iFungicide.
                        	'	'	*	"	I'l	T%5	!	'	'	
                            NelsonN.
                                             ^ Beievue jjejca Center, Laboratory of industrial
                                                                           "''   'i'  ':"'''      '  'i,,
        IliliiiilK
I
                 filMtm	IIH^^^^^^       	!!H^^                               lilH^^^^^^

-------
                                BIBLIOGRAPHY
 MRID
                  CITATION
               Toxicology, submitted by Chevron Chemical Co., Richmond, Calif.;
               CDL:001148-A)
00054791
00057846
00058608
00058940
00058941
00068076
 New York University (1951) Progress Report No. 2: Continuation Studies on
 SR-406. (Unpublished study received Jun 1,1965 under unknown admin, no.;
 prepared by Bellevue Medical Center, Laboratory of Industrial Toxicology,
 submitted by Chevron Chemical Co., Richmond, Calif.; CDLrOOl 148-C)

 Hermanutz, R.O.; Mueller, L.H.; Kempfert, K.D. (1973) Captan toxicity to
 fathead minnows (Pimephalespromelas), bluegills (Lepomis macrochirus), and
 brook trout (Salvelinus forntinalis). Journal of the Fisheries Research Board of
 Canada 30(12):1811-1817. (Also in unpublished submission received Jan 21,
 1977 under 239-533; submitted by Chevron Chemical Co., Richmond, Calif.;
 CDL:230401-C)

 Mitchell, A.D.; Robinson, D.E.; Beck, J.C. (1980) An Evaluation of the Effect of
 Captan on Unscheduled DNA Synthesis in Diploid Human Fibroblasts: Contract
 Nos. 68-01-2458  and 68-02-2947; SRI Projects LSU-3493 and LSU-7558.
 Final rept (SRI International for U.S. Environmental Protection Agency;
 unpublished study; CDL:244432-A)

 Cheng, H.M. (1980) Metabolism of Carbonyl-14C-Captanin a Lactating Goat:
 File No. 721.14/Captan. (Unpublished study received Oct 30, 1980 under
 239-533; submitted by Chevron Chemical Co., Richmond, Calif;
 CDL:243629-B)

 Cheng, H.M. (1980) Degradation Products of Carbonyl-14C-Captan hi Apple
 and Orange Processed Parts: File No. 721.14/Captan. (Unpublished study
 received Oct 30,1980 under 239-533; submitted by Chevron Chemical Co.,
 Richmond, Calif; CDL:243629-D)

 Wong, Z.A.; Bradfield, L.G.; Akins, B.J.; et al. (1981) Socal 1150: Lifetime
 Oncogenic Feeding Study of Captan Technical (SX-944) in CD-I Mice (ICR
 Derived).  (Unpublished study received Jan 29,1981 under 239-533; submitted
by Chevron Chemical Co., Richmond, Calif; CDL:244220-A; 244221; 244222;
244223; 244224; 244225;244226)
                                        135

-------
                           lEJ!!,1,lllllllllllllll!„ "illlllilini,llHi>'' 'IIIIIIUililiiIllllirll'iiilll'lillliifilill'IPIIlii ''•	III! Hill'!!!• V'lliini!,,,.''l!ll!'Jlillllliimllllil1'lib .."li"1!':!!, ml 'IMIAJll!II!!'!1!'" Ullllllllilllllllllll lilil^iiiill!11!11!1!!!11!'1'1'Illilli!,..i ........
                               	CaBforniaJpray Chemical Corporation (1957) Captan Residues-Various Crops.
                  )70414
™5(Reports by various sources; unpublished study received Feb 25,1957 under
    PP0124; CDL:090426-J)
   11 II I'l'PI 111 1 111 III IIII 111 III 111 111 111 11II   nil  II  HI In II ii in i  i iinini ii n i i n iniii 11111 n in in nnnnniii|ii nil  in in n i |i  pi in i n i  i iiii nil in in   ill n 11 iiiiiiiiiiiiiigii
     
     'ack, D.E. (1974) The Soil Metabolism of Carbonyl-14 C-Captan: File
                      |™^^^^^^                             	-___v—g	——-	——	-•—	___	™____	
':	i:	:	,	::;:::;	'	:	:	,::::|;	:	;	":;:::	:	;	:   by Chevron Chemical Co., CDL 120648-B)
          !Łi:&fififiZfiZ5j	Boudreau, P.; Forbis, A.D.; Cranor, W.; et al. (1980) Static Acute Toxicity of
                                                                                    i	Report	#	26633.  .
                                                       ived Jan 12,198111 under 239-1246: prepare^ by
                                                                              	"
  EiiiGIJIiWJilllfiQOiiiifi	ilaife.ChgncuS	Company (1980) Residue Data of Various Chemicals,
                               Including Captan, on Soybeans. (Compilation; unpublished study received Dec
                               12,1980 under AR 80/24; submitted by state of Arkansas for Stauffer;
                               CDL:243877-A)
                               i ni vi in iiiininnniiiinnnniinnninnniinnin 111111111 i inn in iiii nil r                                                        \
               00078623
    Chevron Chemical Company (1979) Teratology Study in Hamsters: IRDC No.
    415-005.  (Compilation; unpublished study, including IRDC no. 999-015,
    received Jun 20? 1979 under 239-1246; CDL: 238658-C)
               00083100      Pack; D.E. (1980) Analysis of Soybeans Grown from Seed Treated with
              IH^	iSl4C-Captan—Greenhouse Study: File 721.14.  (Unpublished study received Mar
                                                 ^~2^7^submitted^by Chevron Chemical Co., gigg^Q^

                                                 iiiipiiiii I. iiiiiiiiiii:iiinii|i TI< lit iiiiiiiii'iiiiiiiiniiiiiniiiiiiii !m nn n i  n n n n n  i in mini nun ml niiiiiiilniinnn n nun iillnninnlnnniniinni nil inn in	in in iiiPiiiiiiiiiiiliiP'MiiiiiiPiPiiiiiii PI niiiiipiniiinnlnipiiiiin in PI  nipiiiiinp i piinin iiiiiinnii in n i
                                                 ,T	„„<	              	||l|||	|lll	I	|	I	I	
                                               icaj	Company (196!}_ The ^termination of and Differentiation
                                                   . .....   ngubished stady received on uitoownd^
               00085525      Petrino, L.M. (1955) Colorimetric Estimation of Captan Surface Residue on
                               Fruit Samples: (Adaptation of Method Published in Analytical Chemistry, July,
                                           1173). Method dated Mar 21,1955. (Unpublished study received
                               May 1, 1955 under PP0015; prepared by Steuer Chemical Co., submittedby
                               S^^S^^l^^^aiai^lCo., ..... Richmond, ..... Calif ŁCDL:090983-q)
	(H
      ^^ rivniiini'	fnn .
                                                       iiiiiiuK];iiii:i'i< 'JIM
                                                                                    	Ii' Hin	II'I'II	illJl|||l(llB/ii|l|||;l<1•l^

             	I!	:	

-------
                                BIBLIOGRAPHY
MRID
CITATION
00085526      California Spray-Chemical Company (1954) Determination of Captan Residues.
               (Unpublished study received May 1,1955 under PP0015; CDL:090983-P)

00086288      Gregory, L.K.; Narcisse, J.K. (1974) The Acute Inhalation Toxicity of Orthocide
               83: SOCAL 5897X111:129 (S-647). (Unpublished study received Sep 24,1975
               under 239-729; submitted by Chevron Chemical Co., Richmond, Calif.;
               CDL:140140-F)

00086803      Rodwell, D.E. (1979) Teratology Study hi Hamsters: 415-005. Amendment to
               the final rept.  (Unpublished study received Sep 28,1981 under 239-1246;
               prepared by International Research and Development Corp., submitted by
               Chevron Chemical Co., Richmond, Calif.; CDL:246246-A)

00087805      Brusick, D.J.; Nguyen, T.D.; McGowan, J. (1981) Mutagenicity Evaluation of
               Captan in the Somatic Cell Mutation Assay: LBI Project No. 20951. Final rept.,
               rev. Includes method dated Apr  10,1978. (Unpublished study received Sep 28,
               1981 under 239-1246; prepared by Litton Bionetics, Inc., submitted by Chevron
               Chemical Co., Richmond, Calif.; CDL:246244-A; 246245)

00009694      Brittain, J. (1964) Preliminary Tests-Delayed Treatments: Alar. (Unpublished
               study received Jun 1,1970 under 400-EX-37; submitted by Uniroyal Chemical,
               Bethany, Conn.; CDL:123446-T)

00090988      California Spray-Chemical Corporation (1957) The Results of Tests on the
               Amount of Residue Remaining, Including a Description of the Analytical Method
               Used: Captan.  (Compilation; unpublished study received on unknown date
               under PP0124;  CDL:090432-D)

00090989      Curtis & Tomkins, Limited (1955) Letter sent to L.W. Hazleton dated Mar 30,
               1955: Determination of captan and tetrahydrophthalimide residues on apples,
               concerning lab. no. 55d40.  (Incomplete; unpublished study received Apr 18,
               1957 under PP0124; submitted by California Spray-Chemical Corp., Richmond,
               Calif.; CDL:090432-E)

00096901       Crossley, J. (1970) The Fate of Difolatan in a Lactating Ruminant (Goat); File
              No. 721.14. (Unpublished study received Jun 9,1977 under 239-2211;
               submitted by Chevron Chemical Co., Richmond, Calif.; CDL: 096157-C)
                                        137

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             (*•:••
                                                                                          •:	,:::	::::	:	:.	i	:::
                                               BIBLIOGRAPHY
              MRID
                                               CITATION
                                                            mM,.\	IIIB	EIIV,
                                                              KIIJII^                              ..... Hini
                                                                             ......... ""
                                                                                  iSK^^
                                                                                                    ..... i
        tililll!-
                                               Mtobojism of Carbonyl 14C Cagtafol in a Lariating Goat:

                                                                           ....... 1 980under 239-221 1; [[[

                                                                             " .....           '
                                       ,,,
                                  ..... Cattel
                                                                              idue ...... Study ..... mLactating
                                                                         1980239211;
                             prepared by Stauffer Chemical Co.,

                	, Calif; CDL:59Sl5T-r)
      'i=S7~~; ES2Q2S274	,	„	Wolfa	NX,;	Zepp, R.G.;Doster, J.C. et al (1976) Captan hydrolysis. Journal of
                                                              j: 10411045. (Also m unpublished
        1 'iirf'in:;!1 : i1;

        '" 'i'uiJ'ri'ii,1
               s^^^^^^^^^^^^^^^^^^     	H,CJi§mical	Co., Richmond, Calif.; CDL:234046-Q

     iiii^^^^^^^^^^^              ......... '. ..... '. ............................ '. ........... , ....... Abell,, J-; Moore, J.E. (1967) Attempjs ...... To Demonstrate tibe ;Translocation of

                                                                               ""
, , =, ...............
                            ''""'1""
                          	^Chevron	Chemical	Company (1979) Residue Data Sheet: Soybeans: Test No.
                                =2369; CDL:237912-
                                                                   11^^^^^	K^tH 1	lililil	!^^^^
               	IH^^^^	    .      	IIK^^^
               10098295      Chevron Chemical Company (1980) One Generation Reproduction1.Studies with

        	•	•	•.<<	;	ill	i	•	i	i	i	Capton' ^g^_|ggg^  (Compilation; unpublished gl^dy received A^pr 5,1982 under
                                                                                        nn  i i i HI iiiniii|ii
^^^
                           ll,.Reproduction Studies, Incmding Diet Analyses. Includes method dated Jun 15,
      	'rjm,M' ^y^^':':^Sl']S'l.Wf^> ^|Compilation; unpublished study received Apr 5,1982 under 239-1246;
      ss^isss	:-SLSSs;S:'^L":23f7i47-D)
  i=^^^^^^^^^^^^^^                 	C^yjE!!	Łh.S2!!?§l	Congj^x..^^	Residue	Sjudies^ofOrtfipc^
  	i'^^^^^omatoes,	(Cpjn^ilatipn; u^ubUshed istudy received Mar 21, j 951 under
                                                     	;	,	;	|(	,,

                                                     	'	7"	:"	'.	!	 	i	!	i	I
j^       ii:,:;! '^'JjjW           ;|l||j|JV^^^^              	!|IW^      	Jill


                           	;	1 «5 o
                           7'	-'	:	:T;	:;	::	'  ;	'	Uo f



     |JH                       	IB^^^^^^^^^^^^^^^^^^^^^^^^^^^     	:.,v:|:!:|S^^^^^^^^^^^^^^^          	
                                                                        JIN                ..iflviiJiV^lg^^^^^^^^^^^^^^^^^
                                                                    liiiiiihilib^
                                                                                               niii iiniriiiiiniiiiinniiiiniiiiiiiniijiiiiEi JiiiiicisiiriB'Sfnnif I
                                                                                  m	

-------
                                BIBLIOGRAPHY
 MRID
                  CITATION
00098709
00098710
00098711
00098716
00098722
00098726
00098731
00098747
00098751
 Chevron Chemical Company (1950) Residue Studies of Orthocide 406 on
 Various Vegetables. (Compilation; unpublished study received Mar 21, 1951
 under 239-533; CDL:001157-C)

 Davis, D.-L. (1950) Residue Analysis~SR-406: Snap Beans. (Unpublished study
 received Mar 21,1951 under 239-533; submitted by Chevron Chemical Co.,
 Richmond, Calif.; CDLrOOl 157-D)

 Davis, D.L. (1950) Residue Analysis-SR-406: Apples. (Unpublished study
 received Mar 21,1951 under 239-533; submitted by Chevron Chemical Co.,
 Richmond, Calif.; CDL:001157-E)

 Kohn; G.K. (1954) Captan Residues on Potatoes. (Unpublished study received
 Jun 2,1954 under 239-533; submitted by Chevron Chemical Co., Richmond,
 Calif.; CDL:001163-A)

 Kohn, G.K. (1958) Letter sent to G.S. Hensill dated May 21,1958: Captan
 residues: postharvest treatment.  (Unpublished study received Jun 20, 1958
 under 239-533; submitted by Chevron Chemical Co., Richmond, Calif.;
 CDL:001194-A)

 Chevron Chemical Company (1950) SR-406: Residues in Various Crops.
 (Compilation; unpublished study received Oct 10,1951 under 23 9-1102;
 CDL:001257-B)

 Kittleson, A.R. (1952) Colorimetric determination of
N-tricUorometMotetrahydrophmalimide. Analytical Chemistry 24:1173-1174.
 (Also In unpublished submission received Feb 21,1973 under 1486-20;
 submitted by Ferro Corp., Bedford, Ohio; CDL:006427-C)

Makhteshim Chemical Works Limited (1969) Merpan: Residue Analysis: DS
 13.51.11. (Unpublished study received Apr 17, 1972 under 11678-1;
CDL:026318-B)

Chevron Chemical Company (1954) Captan Residues in Meat.  (Unpublished
study received May 5,1954 under 239-656; CDL:027009-B)
                                       139

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                                           "'I;	i, iniiB IE ji!1; 'liiiiiPiiiiiii'iiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiliiiiiiiiiiiiiiii'iiiiiiiiiiiiiLin: iiiinii imit atmn, 111111111111 'iiiiiiliiliB: r\ iNiiininF	i i
               ^^^^                                             ..... ;:1K^    ..... Illl
                                                                ..... j1:                           mi
                       iiijH                                      	iiiiiijN^	"p? *is!f' iK!HRttU'iw>i'|iNmHHiitBi
                                                                           :;>•'• C'iMiiMra.	Hiiiiit::!	\	i
>	   h              	
                                                                                            .M^^^^^^       	Ill	I	II
              00098881
    Pack, P.E. (1979) The Anaerobic Soil Metabolism of Carbonyl 14 C-Captan:
                              Ellg Mfl.22JU4.(Unpublished study received Aug. 27,1979 under 239-2457;
                                          ChevronChenucalCq.,Richmond, Calif;;CDL:240891-B)
         l^'	'!	1:"00098784,
                              Pegticiden or on Taro	Leaves,. (Compilation; unpubished study received Jul
                              Mitoma, C  (1972) pilot Study to Determine the Nature and Magnitude of the
                              Residues from Ingestion of Captan in a Ruminating Animal: SRI Project
                              LSC-1697.  (Unpublished study received Mar 7,1977 under 239-2457; prepared
                              by Stanford Research Institute, submitted by Chevron Chemical Co., Richmond,
        !	™-Ł?	•"'	~~^'^	Calif.; CDL:096129-B)
                              Chevron Chemical Company (1976) Captan Residue Analyses-Apples.
                              (Compilation; unpublished study, including test nos. T-3513 andT-3514,
                              received Mar 7,1977 under 239-2457; CDL:096129-H)
              00098790      DeBaun, J.R.; Gruwell, L.A.; Menn, JJ. (1975) The Fate of Captan
                             Carbonyl-14C on Field-grown Apple Trees: MRC-B-44. Rev. (Unpublished
ill	i	i	iiii j	i	i	i (	(Hi	|	  j	I	i	I	i study received Mar 7,1977 under 239-2457; prepared by SjauffeŁCJiemical Co.,
1 *" •'"" M "I  	!'"	Ill	i. I""!11	• 'll"!	I •I	Illllll "'Iffimitted by Chevron Chemical Co., Richmond, Calif!";" a>L:59Sl2$-l5	
              00098804
              00098808
    	:	1	00098810
                                                      i     i
   California Spray-Chemical Corporation (1961) Residue Data Sheet: Almonds:
   Test No. T-239. (Unpublished study received Jan 24, 1962 under 239-533;
   submitted by Chevron Chemical Co., Richmond, Calif.; CDL:121209-A)
  •ill n nil n in n inn 11 in i n ii i ii ii in •• ill n i n inn mi mi in in inii iiiiiiiiii|iii n in  nil i ill  iiiiiiniiiiiiiiiiiiiiii  iiiiiiiiiiiiiiiiiini iiiiiiii mini IIIIIIIIIIIH   up inn 11 iiii i • in  i in mini i mini i   in  i in i ininii
  I            I           ll ' I 1        III  I i  III      I      I I  I       ll             i
   Chevron Chemical Company (1957) Captan: Residues in Cattle. (Compilation;
   unpublished study, including cattle progress report 247, received May 9,1961
   under unknown admin, no.; CDL: 121212-C)

  i              '     ''            i  ;"  fill        ' '(..  ••   '  	
   Cripps, J.M..(1957) Letter sent to California Spray-Chemical Corporation dated
   .EfihJJ?,	1957:	Captan residues--chicken eggs, .breasts, thighs ancl livers.

                                 ^^^^^^^^^^^^^^^^^^^^^^         	II	Ill	II	E	  140
                 '.	#', Mill In	.iiLiliillllllilillliilllijmililP'iilllillLil'il i "i

           iyii',mI:A"^,,M	Ii;iIIi	!;;;<Ł:!;!!lriii!	1
                                                                                       ^^      	i^
 H^^^^^                 	:H^^^^^^
             t"Ii	!	I	i	!"'"]	I"	sir	!	IIj"	"-	I"	"'tli	i	ii	T"	""""	""'	",	!Z	ii	i!	3	'ii	!i

-------
                                 BIBLIOGRAPHY
 MRID
                  CITATION
 00098811
 00098817
00098818
00098831
00098894
00098897
00104083
00104686
 Chevron Chemical Company (1957) Captan Residues in Almonds. (Compilation;
 unpublished study received May 9,1961 under unknown admin, no.;
 CDL:121212-H)

 Chevron Chemical Company (1957) Residue Studies of Captan on Raisins.
 (Compilation; unpublished study received Jun 25,1957 under 239-104;
 CDL:121282-A)

 Pennwalt Corporation (19??) Captan Residue on Cantaloupes Treated with
 Decco Salt No. 10. (Unpublished study received Aug 5,1957 under unknown
 admin, no.; CDL:121594-A)

 Tagawa, H.; Yamaguchi, Y. (1970) Persistence of Captan and Difolatan in Soil
 and Their Absorption by Tobacco Plants from Soil. A translation of: Without
 Title. Bulletin of the Hatano Tobacco Experiment Station, Yokohama,
 Kangagwa, Japan 73:353. (Unpublished study received Jan 4, 1978 under
 239-1246; submitted by Chevron Chemical Co., Richmond, Calif.;
 CDL:232569-H)

 Chevron Chemical Company (1979) Analyses for Orthocide Plus in Potatoes.
 (Compilation; unpublished study received Sep 18,1979 under 239-2474-
 CDL:241047-A)

 Mitchell, A.D.; Robinson, D.E.; Beck, J.C. (1981) An Evaluation of the Effect of
 Captan on Unscheduled DNA Synthesis in Diploid Human Fibroblasts: SRI
 Projects LSU-3493 andLSU-7558; Contract Nos. 68-01-2458 and 68-02-2947.
 Final rept. (SRI International for U.S. Environmental Protection Agency;
 unpublished study; CDL:244432-A)

 Stromberg, K. (1975) Sub-lethal Effects of Seed Treatment Pesticides on
Breeding Hen Pheasants. Doctoral Dissertation, Michigan State Univ., Dept. of
Fisheries and Wildlife. (Unpublished study received Mar 5,1979 under 239-579;
submitted by Chevron Chemical Co., Richmond, CA; CDL:237966-A)

Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1980) Final Report: Subacute
Feeding—Reproduction Screening Bioassay-Bobwhite Quail: Captan Technical
(SX-1086): Project No. 162-123. (Unpublished study received Apr 5, 1982
                                        141

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   iRjiihill	
   i>	•	fsisnr^
     •nil!
                       iij!(H^^                            |[x                tMI^^I^JffSMIKM'itBSfi^i.iUIISS-
                                        TiHHSB^St^fif""'7'
                       IPJiJIin^	1*11 jjlllii, I!N.yiK            !!||i||K
                                          	<5frŁiiaN'
                                       is?!,	mi	
   "i1™ ?• j^Si'ISSSKfSSTIn'der.. 239-1246; preparecl by Wildlife International, Ltd., submitted by Chevron
   	S"	RTaJmonH;	Calif;	CDL:24714733)	
                                       IllhiUllij"!!:!!''!!	iiiCViillllliilQlElliliiiiiillllii:1!!!!
                                                                             ?lil,llll|i!!IWilllilli;ii'!,!!lll|lll!l,ii;,iailllllllll!!1"illl
                                                                                     '''unj;!	liUiii;
                        iiiininiiiiiiiiiiiiiiiniiii^iiiiiiiiiiiiniiijiiniiiiiiiiiiiiiipiiiiiiiiiiiiiiiiiiiiiiiiin
                        |cKay_,	J:C;|1973)	Letter	sent to	Harold	Wright	dated	Mar 2,	1?_73	
                       petenoiiiiations for residues of telrahydrpphthalamic acid-Captan. (Unpublished
                       Igidy received Mar 9'1' 1973 'under 3ET367;	~~p~e" J'g~	g—^j—	chemical1 Co"	
                       subm|ttedby	American	Seed	Trade .Asso^atiqn^Lac^	Kalamazop^Mich.;	
                                                                                                 Ill 1111IIIII Illllll
                                                                                                 iiilllto IIIIIIIIII I
                       Stauffer Chemical Company (1975) Summary of Crop Residue Data Supporting
                       lll "IlillllillllllllllllllllllllllJIIIiSBIIIIIIIIIIIIIIllllll     iiiiilllpiililiiiJilillilllllllllll!;!   	A	, >	I,	,«!,	,	,K,	,	,CH_	Is? 	,	
                                           : Imidan 16:12-WP. (Compilation; unpublished study
                                   2X	1975	unHer^T^SITS;	CDL:	028453-D")	'	
                       Atkins, E.; Greywood, E.; Macdonald, R. (1972) Effect of Pesticides on
                                          0- 1499. Annual rept, 1972.
	r	"	•	I	;	|	-j^ar 28,1975 under 5F1608; prepared by Univ. of C^ifonua--EvŁrside, Dept.
                       o|:gn|omo|O. g-v. Of ^ononuc Entomolo'submitted b  ICI United States
 	I	
     "100114210	Simmon,	V.; Mitchell, A.;	Jprgenson,T. (1977) Evaluation of Selected
                       Pesticides? 355
                                            Mutagens in vitro and in vivo Studies:
............................................ ...... .. ....... .................... j .................... - .......................... • ...... • [[[ i.i.: ................ ................. 1 028; Contract No. 68-01-2458jOHn 3554. (S
[[[ ' [[[    ^^r^nme^j^^otgc^pjiAgency, og|ce of Research and Development, f|
                        Effects
                                     h Laboratory; unpublished study; CDL 248284-E
        00117083
                        Adir, J.; Chin, T.; Ruch, G.; et al. (1982) Captan 50-WP: A Dermal Absorption
                             ^inTRats: T-l 1008. (Unpublished study received Sep 3,1982 under
                        476^-2099; submitted by Stauffer Chemical Co., Richmond, CA; CDL:248429-A)
                       Maddy, K.; Kahn, C.; Riddle, L.; et al. (1977) A Breakdown Study of Captan on
                       Strawberry Foliage and Fruit hi Ventura County, California: ACF 59-372.
      T™^^^^^     ™^^^^^^^^^^^^^^^^^^^             Dept of Food and Agriculture^ Agricultural Chemicals and Feed;
      	DL:	248429^1)	
                                             	m	
                       Maddy, K.; Edmiston, S.; Kahn, C.; et al. (1977) A Study of the Decay of
            	-	!	"	I	f	•	• Captan on the Foliage and Fruit^ of Strawberries in Santa Cruz County,
                                                                         I	|M
              N                              	,;!	iS^^^^
                                                                                         \f't':Vm 'fsvi, Ij'ijljff,	ilili'i1!1!?!!!!	

                                                                   iiii: i Ji Hi'Sif1 'I i"illlhi:iliiii !i iliif iiiiillilhiiiiillilliil, "f"'"' '%Sva' ff~C'/ v •, ti',"»ill;"'"' iiiiiiiiii: I'SiiiEiiiiaiii"1!

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                                BIBLIOGRAPHY
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CITATION
               California: ACF 59-376. (California, Dept. of Food and Agriculture,
               Agricultural Chemicals and Feed; unpublished study; CDL:248429-F)

 00120315      Schardein, J.; Aldridge, D. (1982) One Generation Reproduction Study in Rats
               with Captan: 153-190; T-10486. (Unpublished study received Nov 18,1982
               under 476-2099; prepared by International Research and Development Corp.,
               submitted by Stauffer Chemical Co., Richmond, CA; CDL:249019-A)

 00120316      Goldenthal, E.; Warner, M.; Rajasekaran, D.; et al. (1982) 2-year Oral
               Toxicity/Carcinogenicity Study of Captan in Rats: 153-097. (Unpublished study
               received Nov 18,1982 under 476-2099; prepared by International Research and
               Development Corp., submitted by Stauffer Chemical Co., Richmond, CA;
               CDL:249020-A; 249021; 249022; 249023; 249731)

 00125293      Schardein, J.; Schwartz, C.; Thorstenson, J. (1982) Three Generation
               Reproduction Study in Rats: 153-096.  (Unpublished study received Jan 20,
               1983 under 239-1246; prepared by International Research and Development
               Corp., submitted by Chevron Chemical Co., Richmond, CA; CDL:249334-A)

 00126845      Daly, L; Knezevich, A. (1983) A Lifetime Oral Oncogenicity Study of Captan in
               Mice: Project No. 80-2491. Final rept. (Unpublished study received Apr  14,
               1983 under 239-1246; prepared by Bio/dynamics, Inc., submitted by Chevron
               Chemical Co., Richmond, CA; CDL:249943-A; 249942; 249948; 249944;
               249945; 249946; 249947)

 00127865      Armstrong, D.; Buchanan, D.; Caldwell, R. (1976) A mycosis caused by
               lagenidium sp. in laboratory-reared larvae of the dungeness crab, cancer
               magister, and possible chemical treatments. Journal of Invertebrate Pathology
               28:329-336. (Also In unpublished submission received Apr 21,1983  under
               677-313; submitted by Diamond Shamrock Agricultural Chemicals, Cleveland,
               OH; CDL: 071552-D)

00128355      Chevron Chemical Co. (1982) Residue Chemistry Data: Captan. (Compilation;
               unpublished study received May 19,1983 under 3F2898; CDL:071624-A;
               071625; 071626)

00128621       Bullock, C. (1982) The Eye Irritation Potential of Chevron Captan 90
               Concentrate: Socal 1919 (S-2086). (Unpublished study received May 25,1983

                                        143

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                                                  BIBLIOGRAPHY
               MRID
                       CITATION
                              under 239-2137; submitted by Chevron Chemical Co., Richmond, CA;
                              CDL:250381-A)

               00129157      Saunders, D. (1983) Letter sent to M. Sauahoff dated Jiin 9, L^S^ffistwical
                              data: T-l 0002. (Unpublished[_study received[Jun 15, 1983 under 476-2099;
 	i	i	j	              liiilill	submitted by Stauffer Chemical Co., Richmond, CA; CDL:250668-A)

               00129163      Stauffer Chemical Co. (1982) Revisedj>ages of ^year Oral
                              Toxicity/Carcinogenicity Study bTCaptan in Rate with Caplan Technicaij
 I	I	i	SX944:	153-097.,,	(ynpublishedstady received Jun 15,1983 under 476-2099;
 	'	I"	"	' CDL:25y667-A)

               00129164
                                                                aptan in Rats with Captan Technical,
                              8X944:153-097. (Unpublished study received Jun 15, 1983 under 476-2099;
                              CDL:250667-B)
 liil|i|liniin i n iinniiini iiiiinn i ill in in inn n nnnnnnn 1 1 nnnnnnnn inn n in i inn inn n 1 1 iiinini iniiiii 1 1 iiiiin|iiili i in 1 1 linn iiiiinn in in n i iinillliiininn i n iiiinnn in i n i iinnnlnni iiiiiii iniiini in iiiini ill n P ' n i n i nn i iiiiini i in i n in » iiiiini 1 1 » i inn 1 1 iniiini n n i iinniiiiiiiii inn n in nil 1 1 iiiiiinni « i \\ if iilnnnn illilli i
                                                  i HI ii i inn1! 11 iiniiiiiin ill11!1 iiiiiniiiiniiiiwiiiiiin liniiiiinii nni iiiiniiiiiiiiviiiiiiiliiliniiliiiiiiPiiiiinii iiiiiilinii iiiiiiiiiinniiiii  in I
               00131715
              l|llllllllli III I Illliliillllliillllllillllll
    Ficsor, G.; Bordas, S.; Wade, S.; et al. (1977)
                                                                            stre^tozotodnin sdmonella
              00131725
        	100131727
                                               so In unpublished submission
   receivedJsfov2§, 1980 under unknown admin, no.; submitted by Stauffer
   Chemical Co., Richmond, CA; CDL: 251563-E)
   i    	ill	i	i	||	
   I    	i	                              !|	!	I	I	I	
   Tezuka, H.; Teramoto, S.; Kaneda, M.; et al. (1978) Cytogenetic and dominant
   lethal studies on captan.  Mutation Research 57:201207. (Also In unpublished
   submission received Nov 28,1980 under unknown admin, no.; submitted by
   Stauffer Chemical Co., Richmond, CA; CDL:251563-S)
iiiiiii iiiiiiiiiiliiiiniiillllli ii inn in iiiiinn ill nil i iiiiiiiiiiiiii nn iiiiiiiiiiiiiiiiiiini ii||i||ii|gnin iiiini iniiini in i nl iiiini in i ni iiiini iiiiini in iiiiiillliillllniiiiiliiii i iiiiini in in i 11 iiiiiiiiiiii|iiiiiiiii|iiiiiiiiiiliiiinniiii iiiiiiiiii innnigiinnnnnnnnnnnnninn iiiiini i iiiiiiiilli iiiiiiiiiiiii nil pi in nil nil innini|nni|innin i in iiiiini i iinninninnnnn nn i in i linn ill
   Tezuka, H.; Ando, N.; Suzuki, R.; et al. (1980) Sister-chromated exchanges and
                I aberrations in cultured Chinese hamster cells treated with pesticides
   Jositive in microbial reversion assay's. Mutation Research 78:177-191. (Also In
                                        _^ _.___ ^r^ ujjjjjjQyyjj admin. nO-;
                                 Co., Richmond, CA; CDL: 251563-U)
                                        .,?.; Zwicker, G. (1985)
                         3L._^3L^	,,,—---—^
                                            	I!H^^^
                                       IIB^^^^^^^^^^^^^
                                                     ion Study with Captan
  .gfechpcalj	Fina];ii;||eport: Report No. T-l 1933.  Unpublished, study prepared by
         	[CoTSS	p.	
iiiL\L  ;	!":,,,;  Id  ,
                         "!!-ir- ;•;•
                                                                        	It          ,,.
                     lIlliJEVIliJliiaillllllilliitiiiliiilltieillllilililiiiiiK^                                                         I

                                            ••• ,  , '    , -";' " ,' ii ',  • ,„    ",L|
                                                    J" '•"  " 11    , '.l!" .  "  . 1! .              . ,|   ,,„ 1
                                     	i!:].	'„!'';.	n,M\, ,,J"..J	I	i... ';',•. ..	 ,   • .	L. '	'     i

-------
                                 BIBLIOGRAPHY
 MRID
CITATION
 00151236      Beavers, J. (1978) Acute Oral LD50 Bobwhite Quail: Orthocide Technical: Final
               Report: Project No. 162-102. Unpublished study prepared by Wildlife
               International, Inc. 15 p.

 00153207      Bruyntjes, J. (1984) Incidence of Tumours in CPB: WU Wistar Random Rats:
               Data of Control Animals from Long-term Studies: Report No. V 84/132.
               Unpublished study prepared by Netherlands Org. for Apl. Sci. Res. (TNO). 12
               P-

 00159595      Captan Task Force (1986) Determination of Captan and THPI Residues in
               Crops. Unpublished compilation of methods.  53 p.

 00159596      Captan Task Force (1985) Summary of Residue Data: Orthocide 50W in
               Almonds: Test No. T-6268.  Unpublished compilation prepared in cooperation
               with Morse Labs. 6 p.

 00159597      Captan Task Force (1985) Summary of Residue Data: Orthocide SOW in Red
               Delicious Apples: Test No. T-6649. Unpublished compilation prepared in
               cooperation with Morse Labs. 18 p.

 00159599      Captan Task Force (1985) Summary of Residue Data: Orthocide 50WP in
               Celery: Test No. T-6269. Unpublished compilation prepared in cooperation with
               Morse Labs. 35 p.

 00159601      Captan Task Force (1985) Orthocide SOW Residues in Grapes. Unpublished
               compilation prepared in cooperation with Morse Labs. 29 p.

 00159605      Captan Task Force (1985) Summary of Residue Data: Orthocide SOW in Leaf
               Lettuce: TestNos. T-6276 and T-6285. Unpublished compilation prepared in
               cooperation with Morse Labs. 20 p.

00159606      Captan Task Force (1986) Summary of Residue Data: Orthocide SOW in
               Spinach: Test No. T-6280. Unpublished compilation prepared in cooperation
               with Morse Labs. 12 p.
                                 A
00159607      Captan Task Force (1985) Summary of Residue Data: Orthocide SOW in
               Strawberries. Unpublished compilation prepared in cooperation with Morse
               Labs. 20 p.
                                        145

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                                                Hi	llil'i'"'!i I' ,, Illllllllllll' "illJliillliLl1!1! .1 „!' illllimilllllllllllllL; 'Ik, lll|i|||i''H'lll'!i| nil fl	I	' jillUllllilllllllllilhr ! '"Sh ilnlnllllilliil'lllllllil.llllllilllill,, '^liriiilllillliliillPl.iillilliiilhll ,,E JHi
                                                  ji	 liini1;!!!, 'hi 'I'lLll I,»», :|iii||||||||lll'H||||r .i, 'ifl!'	•lOU'i'I11"1 * lillliliiiliiilllllilliriil.WllilllllllliilP1!,:;:! llllllllllinillllllllilllllllllHIIliiJllillllllllI'llilPlllllllllllilillillllillllllilJiJ'piiilllil,
                                III11II1 hi nil II Hiillll iS'li ill	(ill	IIUl'l	it	illi:' ii '.^OKStilM	9O>k"	9115 *:!	m''fllli, W^^^^^^^^^
                                 111 llll|l|i| 111 I III I ilK^^   	lilt]	!iii<«^     	Hf^nW illlM^^
                                                     CITATION
                                                	ffl^^^^^^^^^^^^^^^^^	iH^^^^^^^^^^^^^      	
                                 ill •• Illilili '.I IM^^^	3
^^^       in „ p
llillll I llillll 111 I II Illlllllllllll  I llillll lIlllllll
  111 Illlllllllllll  Illlllllllllll III
  IIIIIIIII llillll 111 III I llillll
                                               pesticides and other chemicals. Ecotoxicology and Environ.
                                              iiiiiii ..... ii 'i , ..................... • .................................... ' ................. , .................................. " ...... , ............ in» „ ............. ' ....................... , i ......................... , ............. , '" ..................................... n» ......... i .............................. ,' ........ « <:'i ..... ......... ..... ' " ....... 'i. ................ -in''. ........ mtm ................... ,, ......... , ....... ............................. i .............. , .............. ' ........ Hi' .......... ........
  IIIIIIIH^^       llllll llllllH   Illlllllllllll  Illlllllllllll
(Illlllh      	n^mm	I'llilH^^^^^^^^^^^^^^^^^^^^
               00162037      Breault, G. (1986) Addendum to Residue Reduction of Captan and THPI on
                               Crops: Data Call In: R-218.  Unpublished compilation prepared by Chevron
                                            'i	112 ft,,,,	
      	!•   	mi	iiii	ii	i	         	i1	
               00162723       DeBaun, J.; Miaullis, J.;
   •iiiiiii iiiiiiiiiii  ii i  iiiiiiiiiiiiii 11 iii iiiiiiii i ii	           	
     "	•	Ill	tllil'll	i
             11 pur-
                50
•   	ill1:1	v\h	inn	ii	nil	iv	iii	iii
                                                          in-14)in the Rat:ARC/ B-34. Unpublished study
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                           llllll	               TT       ,                                                     	
                               Stevenson, J.H. (1978) The acute toxicity of unformulated pesticides to worker
mu ..... ! ....... ™ ..... " ..... " ............. 1 05020144       Tooby, T.E.; Hursey, PA.; Alabaster, J.S. (1975J The acute toxicity of 102
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III     ....... II ...... Flu! .......
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               40010501
 iiiiii  ii in i iiiiiiiiiii iii  11	140021201
 	1	140021202
          ,liii 11 ii  40021301
          ^^	i	I	liii	I!
               40021401
                               Graham, D. (1986) Captan—Magnitude of the Residues: Poultry and Eggs
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                                                                              ,  '       "    «
                               Chevron Chemical Co. (1986) Analysis and Certification of Product Ingredients:
                               Project ID. 8615386.  Unpublished compilation! 73 p!
                                                                                 iiii i  in  in 111 in  i in
                               Chevron Chemical Co. (1986) Physical and Chemical Characteristics: Project
                               I.D. 8615387. Unpublished compilation. 57 p.
                                                                           11   i1         I     „
                               Chevron Chemical Co. (1986) Product Identity and Composition: Laboratory
                               II 111 III 1111 111 III III I llllll I llllll    I iiilll mill  ill*     J               J          r              ,    J
                               Project ID. 8615385. Unpublished compilation.  127 p.
                                                                                       I                        |

                               Morgan, R. (1986) Acute Dermal Toxicity and Skin Irritation of Captan 90 Dust
                               Base: Lab. Proj. ID T-12526. Unpublished study prepafecl by Stauffer Chemical
                               Co. 14, p.
   ll'I'iM^   i| i ill I'll l|lllllliil llillll l|i I 	llll il'lilliilllp     'II	Iin	111 III ii 11III iiiiiii i '1 iilll|i||||||||| i '111 111	I llillll Hllil11  I "I i'(llli I in ! i|  nil"!  'I illiill i,,l'l llllll 'II i ill III iilllH I iil|i|i"i|il|i 'nlil|i||

                                                             146
                                                                                                iliill'l iiiiiiiiiii ii I iil|ii'i|i|i ' fl	Iiiiiiiiii I II

                             	    	ii	in	
                             Illlllllllllll  I i PI Inllili illliiillllil i I ill II llli i 111 In nl llllll1 lllllllllPilllPI lIlllllll lIlllllll i Illlllllllllll II 111 III I nil illllll I Iiiiiiiiiiiiii iPi I ill Illlllllllllll IP iiilll 111 111 i i ill i 111 Pi llllll II 11 I HP ill

                              	ii  ,           '      'IP   i             " pH'iiii	fhi	IP hi  	i	 i mi

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                                 BIBLIOGRAPHY
 MRID
CITATION
40098001      Mayer,F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Interpretation and
               Data Base for 410 Chemicals and 66 Species of Freshwater Animals. U.S. Fish
               and Wildlife Service; Resource Publication 160: 579 p.

40121701      Makhteshim Chemical Works Ltd. (1987) Product Chemistry: Translation from
               French to English Merpan Captan Technical: MCW 10002. Unpublished study
               15 p.

40189802      Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
               Field Trials: Almond: Chevron Study No. 056131-B. Unpublished study.
               prepared in cooperation with Morse Laboratories.  246 p.

40189803      Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
               Field Trials: Apples: Chevron Study No. 056131-C. Unpublished study prepared
               in cooperation with Morse Laboratories. 454 p.

40189804      Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue:
               Processed Food/Feed Study: Apples: Chevron Study No. 056131-D.
               Unpublished study prepared in cooperation with Morse Laboratories. 82 p.

40189805      Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
               Field Trials: Apricot: Chevron Study No. 056131 -E. Unpublished study
               prepared in cooperation with Morse Laboratories. 163 p.

40189806      Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
               Field Trials: Beet: Chevron Study No. 056131 -F. Unpublished study prepared in
               cooperation with Morse Laboratories.  97 p.

40189808      Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
               Field Trials: Cherry: Chevron Study No. 056131-H. Unpublished study prepared
               in cooperation with Morse Laboratories. 210 p.

40189809      Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
               Field Trials: Corn: Chevron Study No. 056131-1. Unpublished study prepared in
               cooperation with-Morse Laboratories. 187 p.
                                         147

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                                            »Jt»'M	!'1H^^^     	iiji^^^

	ii	:;	=.	i.	;;.!	,:	,	-*,	,	•.*	,;:«	,	;	•:	'='	s	i	••	BIBLIOGRAPHY
                                                  CITATION
                                                                               ii'iiLniiin 'iiiiniiiiLjiiiiPii
               40189811	Reed	D.	Smith Associatejjjtna	Ł1987}	Cagtan: Magnitude of Residue: Crop
                               in cooperation with Morse Laboratories. 378 p.
                                                                         ,  i1       i'
                        ,.                ',              •	:'•'"»',.'  .   V       II                   •:
               40189812       Reed Ł>.Smith Associates, Inc. (1987) Captan: Magnitude of Residue:
  	:	|,	:	,	Processed	Food/Feed	Study: Grapes: Chevron Study 045131-L. Unpublished
i^^                                                                               154 p.
                         '";   '         '                '     ;  	;::;	:	rr:	?	:	:	i	!	!	;	'	•	
               40189813       Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
                               Field Trials: Nectarine: Chevron Study No. 056131 -M. Unpublished study
  •ill i in i  iiii!
  iiiiiiii in ill  lull
                              prepared in cooperation with Morse Laboratories. 151 p.
          i PI iiii iiiiiiiH   iiiiii 111 ii i iiiiiiiii iiiH^ i iiiiiiiiii iln ii in i iiiiiiiiiiiiii i ii iiiiiiiiiiin iiii iiiiii iiiiii ii ii ii 111 iiii i iiiii iiiiiiiiiiiiii iiii iiiiiiiiii iiiiiiiii niiiiiiiiiip       iiiii i in i| n i iiiiiniii|ini iiiiiiiiiii i i in ii
           •ill iiiiiiiii ii i i ii IB  n niiliiini ill iiiiiiiiii inn in iiii iiiiii iiiiiiM i lull    ii     i iiiiiiiiiiiiii i inn in ii iiiiini i niiiiiniH^^          in n Iiiii in in iiiii i iiiiiiiiiiiiii 11 ii i inn
               40189814
,ii^^^        	in	ii     	im	fitifl	ffiifefiflfci a^a^^
                 iiiiiiiiiiiiniiiiiiii m^rni iiiiiiiiii in cooperation with Morse Laboratories.
iiiiiiiiiii i ^m  11 in iiiiiiiii

IlIH
           ii	i
               jjLO J89815
               40 1 898 1 6
                               Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop

                               in cooperation with Morse Laboratories. 339 p.

                               Reed D. Smith Associates, Inc. (1987) Magnitude of Residue: Crop Field Trials:
                               Pear: Chevron Study No. 056131-O. Unpublished study prepared in
                               cooperation with Morse Laboratories.  3 1 6 p.
                              Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
                              Field Trials: Plum: Chevron Study No. 056131 -P. Unpublished study prepared
                                 c,S°Peration wj& Morse Laboratories. 217 p.
                              Reed D. SmiAsciasfac. ........ [l9J7}Cap1an:MagnimdeofResjdue:
                                                         ^raies^hevron Study No" ...... OSSTSMJT'
                              JJnpublished study prepared in cooperation with Morse Laboratories. 77 p.
                                                                                  I!
                              ReedD. Smithy Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
                              Field Trials: Soybean: Chevron Study No. 056131-T. Unpublished study
     IWHCTiwaiisyBBiiBBiHipreparedm cooperation with Morse Laboratories. 174 p.
                                 ii iiii iiii ii ii 111 IK i iiiiiiH iiiiiiiii iiii 111	in iiii in 11 iiii 11	ii im in i iiiii	i iiiiiii|ii 11	iiiiiiiiii1 mmu nil iii' i nil in	i i 1111 iiiii i in ni i  INI	1111 i n	ii i ii P i iiiii i
                                 iiii inn iiiiiiiii ill ill in iiiiiiiii iniiliiiiiii  inuiiiiu             in iiiiiiiii iiiiini  n i iiiiiiiiiiiiii iiii 1111111111111111111111111 ill i in iiiii i i iiiiiiniiiiin in in nil 11 iiiiiiiiii i  MM iiiiii niininn in in niiiiiiiiiin
         left-
             "[35.189821	Reed	D.	Smith	Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
             fElzr^qf^z^il-^Fieid	Trials:	SpSacH:	Chevron Study No. 056131-U. Unpublished snidy	
                            ^•prepared in cooperation with Morse Laboratories. 121 p.
                                               	IIIH^^^^^                         	IIIH^^^          	mw*. is1
      	:	:	:	I	
       ,i,"'HI,',,,,  " •, •'  ilinniiln :,,, ',


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                                BIBLIOGRAPHY
 MRID
CITATION
 40189822      Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
               Field Trials: Strawberries: Chevron Study No. 056131-V. Unpublished study
               prepared in cooperation with Morse Laboratories.  262 p.

 40189823      Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue: Crop
               Field Trials: Tomato: Chevron Study No. 056131-W. Unpublished study
               prepared hi cooperation with Morse Laboratories. 217 p.

 40189824      Reed D. Smith Associates, Inc. (1987) Captan: Magnitude of Residue:
               Processed Food/Feed Study: Tomatoes: Chevron Study No. 056131-X.
               Unpublished study prepared in cooperation with Morse Laboratories.  123 p.

 40208101      Pack, D. (1987) Trichloromethyl Carbo 14 Captan Hydrolysis Products:
               Laboratory Project ID: MEF-0002, 8702383. Unpublished study prepared by
               Chevron Chemical Co. 28 p.

 40208102      Pack, D. (1986) Photolysis of Caaaptan in Sterile Aqueous Solution: Laboratory
               Project ID: MEF-0001. Unpublished study prepared by Chevron Chemical Co.
               13 p.

 40231001      Kuzdas, C.; Frinch, R.(1980) Ames-Samionella/MicrosomeMutagenicity Test:
               Chlorhexidine Diacetate: Laboratory Project No.: 728366: 748579. Unpublished
               study prepared by Raltech Scientific Service.  18 p.

 40231201      Makhteshim Chemical Works Ltd. (1987) Additional Product Chemistry Data:
               Merpan Captan Technical: Makhteshim-Agan Project ID: MCW 10001.
               Unpublished study. 10 p.

40231301      Makhteshim Chemical Works Ltd. (1987) Additional Product Chemistry Data:
               Merpan Captan Technical: Makhteshim-Agan Project ID: MCW 10001.
               Unpublished study. 16 p.

40231801      Thornberry,N. (1987) Physical and Chemical Characteristics: Captan Technical:
               Laboratory Project ID: 8709737. Unpublished study prepared by Chevron
               Chemical Co. 4 p.
                                        149

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                                                 BIBLIOGRAPHY
                                                                         i iiiiiiiH  n ill nil n n in n in i inn  n n ii|iiiiiinnnn i
                                                 CITATION
         liilllii: lin^^^^
         'flfgl.it ]j|IIH^^
           '
                                                 111 III 111" ill 111 111 I Illllllll IIIIIIIIIIIIIIIIIIIIII Illllllllllllll
                                                                                    1 II illllll HI 1 II III III Illllllll  1 1 n 111 111
                                                      1|1 Illllll 1II1II||I|I|1IB III Illllllllllllll llllllll||ll|llllllll
              Johnson, D. (1987) Twenty-one Day Dermal Toxicity Study hi Rabbits with
                                                                           .  153 x
                                                                                 x
0658002
                              Daun, R.
                                                                    14Cap_tan: Nature of tte
                                                                             ......     ......
                                                                          _
1^^^^^^^^                                                                        ...... HLA ...... 6183^105! [[[ [
                           *5»]Qnpublished study prepared by Hazleton Laboratories, Inc. 67 p.
                                             ..... iaijir;jiEfliB             ..... IJIIBH^^                     ...... ivii'U^
                                                                                                            .....  |
        Sj* ..... W^                                                ProectED: HLA 6183106
JJII^IIII I ........ II , -III ..... II IIIIIII ' II spdy prepared by Hazleton Laboratories America, Inc. 62 p.
^^^^^^	& kj4Q658004	:	Daun, R. (1988) Cyclohexene-l,2-Carbon 14Captan: Nature of the Residue hi
                                      "fcLaying Hens: Laboratory Project ID: HLA 6183-104. Unpublished
                                                                                             llllllllll Illllllll llliilllllllllllH
                                                                                             1 4-Captan:
                              Chevron Chemical Co.  37 p.
                                                                      - ........... Unpublished ..... study ..... prepared by
                      56	.Chen,	Y.	(1988)	HantMeteboHsm	Study of Cyclohexene-l,2-Carbon
,	•	"-'^^ ~lT-C§>ten:	I^araSo^"^^"ecJt ID:	MEF-0010/8805420. Unpublished study
         	•	-I	,	••	•	iiii	•	,	i	prepared by
                                   D-; Verrips, I. (1988) Anaerobic Soil Metabolism of Trichhloromethyl- '
Illllll!" lillllf |!P!i||<||" 'Hlllllll'liil' llB 'I 'If Ifflll! i!,!] i T Illilllllllli1 1 'illlililliP'11 
-------
                                 BIBLIOGRAPHY
MRID
CITATION
40658011      Pack, D. (1987) Estimation of Soil Adsorption Coefficient of Captan from TLC
               Data: Laboratory Project ID: MEF-0073/8726836. Unpublished study prepared
               by Chevron Chemical Co.  39 p.

40745400      Captan Task Force (1988) Residue Data submitted for the support of the
               reregistration of Captan Use on crops with a comparison of Air vs Ground
               Concentrate and Dilute Application Methods. Transmittal of 9 studies.

40745402      Reed D. Smith Associates, Inc. (1988) Captan... Magnitude of Residue, Crop
               Field Trials: Almond: Project ID. 87-718. Unpublished compilation prepared in
               cooperation with Morse Laboratories. 125 p.

40745403      Reed D. Smith Associates, Inc. (1988) Captan... Magnitude of Residue, Crop
               Field Trials: Apple: Project ID. 87-304. Unpublished compilation prepared in
               cooperation with Morse Laboratories. 86 p.

40745405      Reed D. Smith Associates, Inc. (1988) Captan... Magnitude of Residue, Crop
               Field Trials: Grape: Project ID. 87-167. Unpublished compilation prepared in
               cooperation with Morse Laboratories. 88 p.

40745406      Reed D. Smith Associates, Inc. (1988) Captan ... Magnitude of Residue, Crop
               Field Trials: Peach: Project ID. 87-984. Unpublished compliation prepared in
               cooperation with Morse Laboratories. 110 p.

40745407      Reed D. Smith Associates, Inc. (1988) Captan ... Magnitude of Residue, Crop
               Field Trials: Peach (WA): Project ID. 87-916. Unpublished compilation
               prepared hi cooperation with Morse Laboratories. 89 p.

40745408      Reed D. Smith Associates, Inc. (1988) Captan... Magnitude of Residue, Crop
               Field Trials: Strawberry: Project ID. 87-722. Unpublished compilation prepared
               in cooperation with Morse Laboratories. 107 p.

40752301      McKay, J. (1988) Captan and THPI-Storage Stability Study: Various Crops:
               Interim Report: Laboratory Project ID RRC-88-35. Unpublished study prepared
               by Chevron Environmental Center in cooperation with Morse Laboratories, Inc.
               and Hazleton Laboratories America, Inc. 247 p.
                                         151


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                                BIBLIOGRAPHY
MRID
CITATION
               Pan-Agricultural Laboratories, Inc., in cooperation with McKenzie Laboratories,
               Inc. 240 p.

41039101      Biehn, W. (1989) Captan: Magnitude of Residue on Blueberry: IR-4 PR No.
               3458. Unpublished study prepared by Morse Laboratories, Inc. 237 p.

41149101      Curry, K. (1989) Captan Magnitude of the Residue Study in Soybeans Grown
               from CAPTAN-treated Seed: Project ID WRC 89-31. Unpublished study   '
               prepared by Morse Laboratories, Inc.  125 p.

41149102      Curry, K. (1989) Captan Magnitudes of the Residue Study in Spinach Grown
               from CAPTAN-treated Seed: Project ID WRC 89-32. Unpublished study
               prepared by Morse Laboratories, Inc.  152 p.

41149103      Curry, K. (1989) Captan Magnitude of the Residue Study in Corn Grown from
               CAPTAN-treated Seed: Project ID WRC 89-33. Unpublished study prepared by
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41149104      Curry, K. (1989) Captan Magnitudes of the Residue Study in Beets Grown from
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41176301      Lee, K. (1989) Trichloromethyl-carbon 14 Captan- Hydrolyisis at 25
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               Unpublished study prepared by ICI Americas Inc.  3 7 p.

41234402      Hext, P. (1989) Captan: 90-Day Preliminary Inhalation Toxicity Study in the
               Rat: Project ID's: Report No. CTL/P/2534; CTL Ref. No. Y01716/011/001.
               Unpublished study prepared by ICI Central Toxicology Laboratory.  718 p.

41306101      Curry, K. (1989) Captan: Magnitude of the Residue Study on Winter Wheat
               Grown from Captan-Treated Seed: Lab Project Number: RR/89/053B.
               Unpublished study prepared by Morse Laboratories, Inc. 188 p.

41306102      Curry, K. (1989) Captan: Magnitude of the Residue Study on Soybean Forage
               Grown from Captan-Treated Seed: Lab Project Number: RR/89/062B.
               Unpublished study prepared by Morse Laboratories, Inc. 104 p.
                                        153

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                                             BIBLIOGRAPHY
           	MRID
	CITATION	;	

->	HI	
                                                                                     . 166: The
                       ; ...................  ......... DetemMnatioBofEesiduesof
                            Tetrahydrophthalimideand 5-Hydroxy Tetrahydrophthaiimidein Milk and
                           FMethod'Usjng External Standardization. Unpublished study prepared by ICI
                                      "Is. 38 p.
                          "I Laboratory-West. 124 p.
                    	:	,;	,;,	'.	_	Sjation.	30 p.
                                                                152	^Readi^^n^SjIlydiOTjj;
                                                    hi Eggs: Lab Rrc^eiBtNumber:	Np967-0701:	ICI	'	
                               ;ocgl NO. G^fflrGLrAMrOi/Unpublished study prepared by Battelle. 27
                                                     	_	
                                ;-carbon 14 and TricHoromethyl-carbon
                               leat: Lab Project Number: PTRL-EAST 241: PTRL-WEST 137W.
                            Davy, G.; Atreya, N. (1989) The Determination of Residues of
                                                                        imideand 5-Hydroxy
                                          midein Eggs: A Gas Liguid Chromato§raphic Mass-selective
                            Detector	MeJioAUsJng	External	StandarSsation.	...Metiio^No.	152.	
                        3^jys.puDlisned study prepared by ICI Agrochemicals, Jealotts Hill flesearch
                                 'K- O ?90) ?:esidue Data Review for Soybean and Wheat Seed Treatments
                                                    Residue Data Review for Corn, Soybeans, Beet and
                            Spinach Seed Treatments with Captan, DEB No. 5589, EPA No. 239-124;
                        ,_.	I	MBJD	Mg§=	I11491-Q1	||ffiuigh-p4.^1^ublished study prepared by Captan f ask	
                           .Trivedi, S, (1990) Captan: Excretion and Tissue Retention of a Single Oral Dose
                                    	~	-	:	URQ282T	
                            study prepared by ICI Central Toxicology Laboratory. 37 p.
                                                                                               •	i	:I?"	
                                                                                	-	:	:	:	:	L	:	1

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                                 BIBLIOGRAPHY
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                  CITATION
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41505404
41557601
41746001
41826901
42109601
42254201
 Trivedi, S. (1990) Captan, Excretion and Tissue Retention of a Single Oral Dose
 (500 mg/kg) in the Rat: Lab Project Number: CTL-862: UR0283. Unpublished
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 Lappin, G.; Havell, M. (1990) Captan: Biotransformation Study in the Rat: Lab
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 Bratt, H. (1990) Captan: Repeat Dose Study (lOmg/kg) in the Rat: Lab Project
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 McKay, J. (1990) Captan and THPI-Storage Stability Study: Various Crops.
 Storage Stability Validation for Captan (N(trichlorometh ylthio)
 cyclohex-4-ene-l,2-dicarboximideand THPI (tetrahydrophtalimide)in Raw and
 Processed Agricultural Commodities: Lab Project Number: RR90-368B.
 Unpublished study prepared by Chevron Environmental Ctr. in coop, with Morse
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 Chen, Y. (1988) Plant Metabolism Study of (trichloromethyl-carbon
 14Cyclohexene-l,2-carbon 14)-Captan: Lab Project Number:
 MEF0010/8805420:MEF-0009/8808900. Unpublished study prepared by
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 Tinston, D. (1991) Captan: Teratogenicity Study in the Rabbit: Lab Project
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 Toxicology Lab. 3 65 p.

Yeh, S. (1988) Addendum to  Carbon-14 Captan Plant Metabolism Studies: Lab
Project Number: MEF-009: MEF-010: RR 91-091B. Unpublished study
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McKay, J. (1990) Captan 50-WP: Magnitude-of-the-Residue Study on Apples:
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Inc. and Morse Laboratories, Inc.  145 p.
                                        155


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                                BIBLIOGRAPHY
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42756401      Renwick, R.; Skidmore, M. (1993) Captan: Metabolism in Hens Following
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42803901      Rhodes, M. (1993) An Addendum to MRIDs 40752301,41557601, and
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43012903      Krieger, R.; Ross, J.; Thongsinthusak,; T. (1987) Assessing human exposure to
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43266701      Mathis, S.; Skidmore, M. (1994) ((Carbon 14)~Trichbromethyl) Captan:
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               RJ1639B.  Unpublished study prepared by ICI Agrochemicals, Jealott's Hill
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43266702      Powell, S.; Miles, P.; Skidmore, M. (1994) ((Carbon 14)~Trichbromethyl)
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43393501      Provan, W.; Eyton-Jones, H.; Green, T. (1993) First Revision to The Potential of
               Captan to React with DNA: Lab Project Number: CTL/R/1131: HR2172.
               Unpublished study prepared by Zeneca Central Toxicology Lab. 30 p.

43393502      Robinson, M. (1994) Captan: A CTL Re-examination of Duodenal Sections
               from a Lifetime Oral Oncogenicity Study in Mice (Bio/Dynamics Project No.
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43393503      Allen, S. (1994) Captan: Investigation of Duodenal Hyperplasia in Mice: Lab   ,
               Project Number: CTL/L/5674. Unpublished study prepared by Zeneca Central
               Toxicology Lab.  12 p.
                                        157

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                                                                        	;,	1	,	
                                                                        :i'.;;«:: ;!!:L;!iiinjijjjiji|iii
                                             OTAIION
                                 ,„,''!          i  ' i      .         i    i'1!	 ',n  '	 I I
                                                : Second Investigation pJJJupdenal Hyperpasia in Mice:
                                                                                                '
                             neca .....  gntr, Toxicfiogy Lab.
                                    arJ.. UbcottCo.
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                                                                                        ..... i'liia,!!^
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                              Edition; p. 1151-1157. Philidelphia: W.B. SaundersCo.
                              llVlllllliihIlJlllllllllllliilnlLilUllhllllllllllllllll                      liilliliiihlilllilllilliilililliiill
           23393507	LŁiningerLJ.;	JoMnen,	M.	(1990)	27.	Ovidj^t?iiiiUterus,	and	Vagina, p. 443-459
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     ^-";\	43405101	;	Gprdpn,	E.;	Foster,	J.;	Bernard,	B.	et	aLjl99Ł)	Response to 59	FR 33941	'	
                        ni^ummanang Data Concluding^ Captan is Not a ^Human^ Carcinogen: Lab Project
                          =;Humbe"r-:	:
                          jPritchard, IX; Lapp, G. et al. (1991) Captan: DNA Binding; Study in theMouse:
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                                                     EaviionmenteMutagenesis9(1987):297-O06"
           [4340J104
Haseman,	J:;	iWinbush,i	J. •	O^onnell,	M.	(1986) Captan: Use of Dual Control
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Fundamental and Applied Tox. 7(1986):573-584
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                                                                            	1	
                          Amsimpv/V.;	Alexandroy,"V.;	pe§o^	^	et	al'Jl^'iinF)^
                                             .in;	Single Admhiistrationto Female' Rats.  Carcinogenesis

                          liiIIIEiiflK                                   ..... jiEJlM^^
                                                                                                      ..... ' ....... •Ill

EilIB^      	MIW                     	IIK^^^^^^^^^^^              >Hi	m

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                                 BIBLIOGRAPHY
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43405109
43548601
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 Wiebe, L.; Westberg, G.; Clark, S. (1992) Captan: Determination of Residues of
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 Meyers, T.; Wiebe, L. (1995) Captan: Stabilities of Captan in Milk and Five
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 Stewart, K.M.; Tapp, S.A.; Stanley, S.A.; Stanley, R.D. (1991) Captan: Chronic
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 Biehn,W.  (1997) Captan: Magnitude of Residue on Raspberries - 1995 Trials:
 Lab Project Number: B3953: B3953.95 -NDR04: B3953.95 - MI21.
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 Hour Toxicity Test with the Freshwater Alga (Anabaena flos-aquae)" Wildlife
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April 14, 1999.

Drottar, K.R., and Krueger, H.O. (1999e). Unpublished Report: "Captan: A 96-
Hour Acute Toxicity Testwth the Marine Diatom (Skeletonema costatum)"

                          159

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                                  	iiiiiw^^^                           iiiiiii«^	iiliiR     	IIIIIH^^^        '	                       |

'	'	
                               Wildlife International Ltd., Easton, MD, 493 A-102, Stewardship Task Force.
                               April. 14,1999.
               ^SUODUJJ       Drottar, K.R., and Krueger, H.O. (1999a). Unpublished Report: "Captan: A 7-
  	I	!	i Day Toxicity Test with Duckweed (Lemna gibba G3)." Wildlife International
                               Ltd., Easton, MD, 493A-103, Stewardship Task Force. April 14,1999.
......... ................... I ....................... ,
                           ..... ...........................        , ......   ^and ..... Krueger, H.O. (1999c). Unpublished Report: "Captan: ....... A ...... 96:
                           ! ........................ Hour TToxicity Test with the Sheepshead Minnow (Cyprinodon variegatusj
                               International Ltd., Easton, MD, 493A-103, Stewardship Task Force. April 14,
  [[[ 1999
               44806505       Drottar, K.R., and Krueger, H.O. (1999b). Unpublished Report: "Captan: A 96-
  	i	,	_	i	^	HourniStatic	Acute,	toxicity Test with the Saltwater Mysid (Mysidopsis bahia)."
           ir'i!''	^^^^LUd^'Es^m^'MD,493A-lQ3t stewardship	*
                                       ;	1599:	
HffijEHjSSS SEJL |GS 120-001	Lukens, R;	Sisler,	H.	Ł195 8]_ Qiemical reactions involved in the fungitoxicity of

                               captan. Phytopathology 48:23 5:244. Published study.
                              	i                                              i         i
                               Hoffman, L.; Debaun, J.; Knarr, J.; Menn, J. (1973) Metabolism of N-
                      ==
                               Report No. ARC-B-36. Submitted by Stauffer Chemical Co.
                                lllliiil iifNli 11111111111111111 ill in 111 iiiii  111 iiiii lllllllllllll  1 11 iiiii i run 111 iiiiiii iiiiiiiiiiiiiiii mmm 11 iiiiiiiiiiiiiiiiiiiiii ill iiiiiiiiiiii iiiiiiiiiiiiiiii 11 i  iiiiiiiiiiii  nil iiiiiiiiiiii iiiiiiiiiiii iiiiiiiiiiii
                                iiiii iiiiiiiiiiiiiiiiiiiiii in i iiiiiiiiiiii inn iiiiiiiiiiiiiiiiii in iiiiiii iiiii iiiii iiiiiiiiiiiiiiii in iiiiiiiiiiii  in iiiiiiiiiiii in iiiiiiiiiiii iiiii iiiii 111 iiiiiiiiiiii iiiii iiiii iiiiiiiiiiii iiiii i il i |i iiiii 11 in in iiilili iiiii   iiiiiiiiiiii  in  iiiii  iiiiiii iiiiiiiiiiiiiiii iiiii iiiii i

         	-•	i ii	SSi2P-OQ8	Chevron Chemical Co. (1978) Determination of captan residues in crops: RM-
         	i'.nr,;' Illlin^           '^illllll iiiuiiiii i niiii iiiiiiiiiiii iiiiiiiiiiiiiiiiii 11 nil! iiiiiiiiiiii in     '                    c                  r
                               1 ^-2. Unpublished method dated June 5,1978.
                                 •        11 111 11 111 11 ilil||||||i|||li 111 Illii I il|l|i |l| P 111 lliilill i IP i II 111 11	Ill ill|||||i||||||||||i pi Illli Iiilili i Illlll illlliiill i |l llli|i|||llll|||llillilll|iiH	Ill	II	II Hill (I Illllll 111^ •llil|i||||l  11
               GJOJ22-1I     Pomerantz,I.(1968) Residue method for captan, folpet, and difolatan.
                               1^          sent to Petitions Review Branch, September 9. 1968.
                                                                                                        fish
                            H^SSEifguatic invetebrates. U.S. Fish and Wildlife service Publication No. 137
                            	:on, D.C	
                                                       in   in  MI  ii iiiiiiiiiiiiiiii iiiiiiiiiiiiiiii i iiiiiiiiiiiiiiii i ipti iiiii | in iiiiiiiii in   i iiiii   i

       ii='	=i^i^Ql^3l^	~~.^
                                                                                                        •I iiiii i iii iiiii i ii i iiiii 11 nil
                               submitted by American Seed Trade Association under Petition 3E1357.
                                                            160
                                                                                                                 IE-:;;	  I
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                                BIBLIOGRAPHY
MRID
CITATION
GS0120-41     U.S. EPA (1979) 48-hr EC50 study of technical captan to Daphnia magna.
               Laboratory of Terrestrial and Aquatic Biology, Chemical and Biological
               Investigations Branch, Beltsville* MD.

GS0120-42     U.S. EPA (1979) 96-hr LC50 study of technical captan to bluegill. Laboratory of
               Terrestrial and Aquatic Biology, Chemical and Biological Investigations Branch,
               Beltsville, MD.

GS999-001     Hudson, R,; Tucker, R.; Heagle, M. (1984) Handbook of Toxicity of Pesticides
               to Wildlife. U.S. D.I. Publication 153, Washington, D.C.
                                        161

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$
                   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                       WASHINGTON, D.C. 20460
 GENERIC DATA CALL-IN NOTICE
                                                                            OFFICE OF
                                                                       PREVENTION, PESTICIDES
                                                                       AND TOXIC SUBSTANCES
 CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active ingredient(s)
identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to submit certain
data as noted herein to the U.S. Environmental Protection Agency (EPA, the Agency). These data are
necessary to maintain the continued registration of your product(s) containing this active ingredient(s).
Within 90 days after you receive this Notice you must respond as set forth in Section III below. Your
response must state:

Lhow you will comply with the requirements set forth in this Notice and its Attachments 1 through
  4; or,

2.why you believe you are exempt from the requirements  listed in this Notice and in Attachment 3,
  Requirements Status and Registrant's Response Form, (see section III-B); or,

3.why you believe EPA should not require your submission of data in the manner specified by this
  Notice (see section III-D).

  If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with its
requirements or should be exempt or excused from doing so, then the registration of your product(s)
subject to this Notice will be subject to suspension. We have provided a list of all of your products
subject to this Notice in Attachment 2, Data Call-In Response Form, as well as a list of all registrants
who were sent this Notice (Attachment 4).
                                          163

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            	Hi1
                                         	I	
                                                                	 iiiKiiiiiiiii I! lin
  The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
 Rodenticide AcJ as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this information
 is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107 and 2070-0057
 (expiration date 3-31-99).
                                                           >i
      This Nptice is divided into six sections and five Attachments.  The Notice itself contains
 information and instructions applicable to all Data Call-In Notices.  The Attachments contain specific
 chemical information and instructions. The six sections of the Notice are:
  Section I
  Section II
  Section III
  Section iy
  Section V
  Section VI
                          Why You Are Receiving This Notice
                          Data Required By This Notice
                          Compliance With Requirements Of This Notice
                          Consequences Of Failure To Comply With This Notice
                          Registrants' Obligation To Report Possible Unreasonable Adverse Effects
                          Inquiries And Responses To This Notice
      The Attachments to this Notice are:
111 1H llllllH Iiililllllll 1H^^      	illllll^  'I iiililllllll^  llllllllllllll lllll|i|lllllliil illiii^^ III (in l\m 11 lilll 1IH 111 | iiililllllll I1 i 111 11111H^^ 111 Hi ' 1111 II Illiilijlinii 111 iiililllllll	Hill1 I	
     Attachment 1  -      Data Call-In Chemical Status Sheet
     Attachment 2  -      Data Call-In Response Form (Insert A)
     Attachment 3  -      Requirements Status And Registrant's Response Form (Insert B)
     Attachment 
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         You are required to submit the data or otherwise satisfy the data requirements specified in
  Attachment 3, Requirements Status and Registrant's Response Form (Insert B), within the time
  frames provided.

  C.     TESTING PROTOCOL

         All studies required under this Notice must be conducted in accordance with test standards
  outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
  established.

         These EPA Guidelines are available from the National Technical Information  Service
  (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-605-6000).

         Protocols approved  by the Organization for Economic  Cooperation and Development
  (OECD) are also acceptable  if the OECD-recommended test standards conform to those specified
  in the Pesticide Data Requirements regulation  (40  CFR  §  158.70).  When  using the OECD
  protocols, they should be modified as appropriate so that the data generated by the study will satisfy
  the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for complying
  with data requirements when the studies were  not  conducted in accordance with acceptable
  standards. The OECD protocols are available from 2001 L Street, N.W., Washington, D.C. 20036
  (Telephone number 202-785-6323; Fax telephone number 202-785-0350).

        All new studies and proposed protocols submitted in response to this Data Call-In Notice
  must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].

  D.    REGISTRANTS RECEIVING PREVIOUS SECTION 3(cY2)(B} NOTICES ISSUED BY
        THE AGENCY

        Unless otherwise noted herein, this Data Call-In does not in any way supersede or change
  the requirements of any previous Data Call-InfsX or any other agreements entered into with the
  Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
  Notices to avoid issuance of a Notice of Intent to Suspend their affected products.

SECTION IH.  COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

  A.    SCHEDULE FOR RESPONDING TO THE AGENCY

        The appropriate responses initially required by this Notice must be submitted to the Agency
  within 90 days after your receipt of this Notice. Failure to adequately respond to this Notice within
  90 days of your receipt will be a basis for issuing a Notice of Intent to Suspend (NOIS) affecting
  your products. This and other bases for issuance of NOIS due to failure to comply with this Notice
  are presented in Section IV-A and IV-B.
                                         165

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         vsm	IB.
                     OPTIONS FOR RESPONDING TO THE AGENCY
  IliH
f                cl
                5
                       .e options for responding to this Notice are: 1) voluntary cancellation, 2) delete use(s), (3)
              cjaim generic data exemption, (4) agree to satisfy the data requirements imposed by this Notice or
              (5) request a date waiver(s).
                                           I HIM 1 1 1 1 III Hill 111 1 1 III 1 1 1 1
                                           iinili|i|i iinniiiiliiii mini n
      iiiii iiii i ii
      11 iiiiii
                       A discussion of how to respond if you chose the Voluntary Cancellation option, the Delete        I
              llllll 111 I • 111 IH^^                         ..... m ..................................... „ ............................... m [[[ ' [[[ ' ............... - ...................... [[[ ........ FE ............. ......................... ,,m ..................... , ....................... ...... ;' ................. [[[ |
                Use(s) option or the Generic Data Exemption option is presented below. A discussion of the various
                options available for satisfying the data requirements of this Notice is contained in Section III-C.
                A discussion of options relating to requests for data waivers is contained in Section III-D.

                       There are two forms that accompany this Notice of which, depending upon your response,
                one or both must be used in your response to the Agency.  These forms are the Date-Call-in
^^™™	' -	-	|-	Response Form (Insert A) and the Requirements status and Registrant's' Response Form (Insert B).
                The Date Call-tn Response Form (Insert A) must be submitted as part of every response to this
                Notice. Please note that |he company's authorized representative is required to sign the first page
                of the Date Call-In Response Form (Insert A) and Requirements Status and Registrant's Response
                Form (Insert B) and initial any subsequent pages. The forms contain separate detailed instructions
                on the response options. Dp not alter the printed material. If you have questions or need assistance
                in preparing your response, call or write the contact person identified in Attachment 1.
                                                                             ,„,''""               '
                       1,     Voluntary Cancellation -  You may avoid the requirements of this Notice by
                       requesting voluntary cancellation of your product(s) containing the active ingredient(s) that
                       is the subject of mis Notice. If you wish to voluntarily cancel your product, you must submit
                       a completed Date Call-In Response Form (Insert A), indicating your election of this option.
                       Voluntary cancellation is item number 5 on the Date Call-in Response Form (InsertA). If"
                       you choose this opSon, mis is the only form that you are required to complete.
                               	;	:	•	i	;	,	[	
                              if you cnoose to voluntarily cancel your product, further sale and distribution of your
                       product after tEe effective date of cancellation must be in accordance with the Existing
                       Stocks provisions of this Notice which are contained in Section IV-C.
                                                                       11'   " i     '   11      i ' 11 i
                          III  II Illlllllllllllllllllllil i 111 III lllllllll 111 IIIIIIIB^^       Illllll I lllllllll 11 Illllllilllllllllllllllllllllllllllllil lllllllll 111 lllllllll lllllllll 111 il 111 llllliillllllllllilliH   llllilllllilllll Illllll lllllllll 11 illllll III If 111 lllllllll I 111 111 II lllllllll lllllllll lllllllll lllllllll lllllllll I 111 lllllllll lllllllll
                             	Use Deletion-	Youjna^	avoid	Ae^eguirements of this Notice by eliminating the
                          s of your product to which the  requirements  apply.  If you wish to amend your
                          .station to delete uses, you must submit the Retirements  Status and  Registrant's
              I	' .Resr»rise'Torm7!nsert
                       amended labeling, and all other information required for processing the application.  Use
11A       iillllin i||iiii|| 111 lllllllll deletion,	is	option number 7 on the Requirements Status and Regisfrant's Response Form
™^^^™    H^^
  i	i	i	certification item number 8. Application forms for amending registrations may be obtained
  •Hi1"*11 mi  ^l""	IIBI!llfiom the Registration §upport and Emergency Response  Branch,  Registration Division,
                       (703):
i ill iiii ii i
              iiiiiii PI iiiiiii

                                                                                   1
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        If you choose to delete the use(s) subject to this Notice or uses subject to specific
 data requirements, further sale, distribution, or use of your product after one year from the
 due date of your 90 day response, must bear an amended label.

 3-      Generic Data Exemption - Under section 3(c)(2)(D) of FIFRA, an applicant for
 registration of a product is exempt from the requirement to submit or cite generic data
 concerning an active ingredients) if the active ingredient(s) in the product is derived
 exclusively from purchased, registered pesticide products containingthe active ingredient(s).
 EPA has concluded, as an exercise of its discretion, that it normally will not suspend the
 registration of a product which would qualify and continue to qualify for the generic data
 exemption in section 3(c)(2)(D) of FIFRA. To qualify, all of the following requirements
 must be met:

        a.      The active ingredient(s) in your registered product must be present solely
        because of incorporation of another registered product which contains the subject
        active ingredient(s) and is purchased from a source not connected with you; and,

        b.      every registrant who is the ultimate source of the active ingredient(s) in your
        product subject to this DCI must be in compliance with the requirements of this
        Notice and must remain in compliance; and

        c.     you must have provided  to EPA an accurate and current "Confidential
        Statement of Formula" for each of your products to which this Notice applies.

        To apply for the Generic Data Exemption you must submit a completed Data Call-In
 Response Form (Insert A), and all supporting documentation. The Generic Data Exemption
 is item number 6a on the Data Call-In Response Form (Insert A). If you claim a generic data
 exemption  you are not  required to complete the Requirements Status and Registrant's
 Response Form (Insert B).  Generic Data Exemption cannot be selected as an option for
 product specific data.

        If you are granted a Generic Data Exemption, you rely on the efforts of other persons
 to provide the Agency with the required data.  If the registrants) who have committed to
 generate and submit the required data fail to take appropriate steps to meet the requirements
 or are no longer hi compliance with this Data Call-In Notice, the Agency will consider that
 both they and you are not in compliance and will normally initiate proceedings  to suspend
the registrations of both your and their product(s), unless you commit to submit and do
 submit the required data within the specified time. In such cases the Agency generally will
not grant a tune extension for submitting the data.

4-     Satisfying the Data Requirements of this Notice - There are various options available
to satisfy the data requirements of this Notice. These options are discussed in Section III-C
of this Notice and comprise options 1 through 6 on the Requirements Status and Registrant's
Response Form (Insert B) and option 6b and 7 on the Data Call-InResponseFormdnsert A).

                                  167

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                        ijlf	vou^ choose ogtion  6b or  7,  vou  must  submit  both forms as well  as any  other
                          foimation/data pertaining to the option chosen to address the data requirement
                                           	iiiilliliSiflllJlB1 lilNIIIilllllllllllllll'i11 S	
                                Request for pafa Waivers.  >a|a waivers are discussed in Section in'-D of this Notice
                                Covered	by^	options 8 and 9 on the Recjuirements Status and Registrant's Response
                               Insert B).  If you choose one of these options, you must submit both forms as well as        I
                        any other information/data pertaining to the option chosen to address the data requirement.
                 C.
SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
           	I	If you ackno wjedge on the Date Call-in Response Form (Insert A) that you agree to satisfy
                 tiiie] jjg^j^ujjrcnjenfcs (i.e. you select ogtion 6b and/or 7), Siien vou must select one of the six options
           '	"	|	i'on the Requirements Status and ItegistiS's Response Form f Insert A) rejated to date production
                 for each data requirement.   Your option selection sh"ou|5  b"e entered under item number 9,
                 "Registrant Response." The six options related to data production are the first six options discussed
                 under item 9 in the instructions for completing the Requirements Status and Registrant's Response
=	2	'=	;"	i	s;	~	"	••	* to guide registrants to additional instructions provided in this Section.  The options are:
                sBiKiisrli	Liidll generate and submit data within the specified tune frame (Developing Data),
                                                         •merit with pne or more registrants to develop data jointly
                                                                  uiin^^^^

                        ?.     I am gjgggg^g gjj existing s^jy gat has not been submitted previously to te
                             I2Asency ^ anyone (Submrttrng an Existhig Study),

                       	,	 ;	,i   ,    ,, , iin  »             	      ;       ,    "i;    ,  ,i  '   '   . I                 i, • »'i '  	p»
                        5:     I am submitting or citing data to upgrade a study classified by EPA as partially
                       	"	"e	anH'j^pglriHeabTs1	^jpg^g-—	~	"	
                               I am citing an existing study that EPA has classified as acceptable or an existing
                                                               : not reviewed by the Agency (Citing an Existing
                               Study).
jiiinnininnnnnnniiii^^     111 nil mi iliiilinn nil inn 11 iiiiini in n iiiiiiiniini iinniinninnniiiiiiiwipii innnnnnnnnniiiniinnni 111 iiiiwiininiiiiiiiiiniiniiiiiii iiniinin niinwiiniiiiiiiniiiiiiiiiii iiw liiiiiiiwiiiiiMiniNiiiiiiiin niiiinnniiiiiiiiiiiiiiiiii i iiiinni ninni i i mil n nil 11 iiiiiiiini wiiniii i in nw iiiilniiiiiw n iiniiiiiiinininini i niiiiiiipiiiii inn  n  n win iiiiiiiiiiiiiiini ill iiipiniiiiiiinnni iniiiinillii iiiiiiiiini I

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 studies for which a protocol must be submitted have been identified in the Requirements
 Status and Registrant's Response Form (Insert B) and/or footnotes to the form.  If you wish
 to use a protocol which differs from the options discussed in Section II-C of this Notice, you
 must submit a detailed description of the proposed protocol and your reason for wishing to
 use it. The Agency may choose to reject a protocol not specified in Section II-C.  If the
 Agency rejects your protocol you will be notified in writing, however, you should be aware
 that rejection  of a proposed protocol will not be a basis for extending the deadline for
 submission of data.

       A progress report must be submitted for each study within 90 days from the date you
 are required to commit to generate or undertake some other means to address that study
 requirement, such as making an offer  to cost-share or agreeing to share in the cost of
 developing that study. A 90-day progress report must be submitted for all studies. This 90-
 day progress report must include the date the study was or will be initiated and, for studies
 to be started within 12 months of commitment, the name and address of the laboratory(ies)
 or individuals who are or will be conducting the study.

       In addition, if the time frame for submission of a final report is more than 1 year,
 interim reports must be submitted at 12 month intervals from the date you are required to
 commit to generate or otherwise  address the requirement for the study. In addition to the
 other information specified in the preceding paragraph, at a minimum, a brief description
 of current activity  on and the status of the study must be included  as well as a full
 description of any problems encountered since the last progress report.

       The time frames in the Requirements Status and Registrant's Response Form (Insert
 B) are the time frames that the Agency is allowing for the submission of completed study
 reports or protocols. The noted deadlines run from the date of the.receipt of this Notice by
 the registrant.  If the data are not submitted by the deadline, each registrant is subject to
 receipt of a Notice of Intent to Suspend the affected registrations).

       If you cannot submit the  data/reports to the Agency in'the time required by this
Notice and intend to seek additional time to meet the requirements), you must submit a
request to the Agency which includes: (1) a detailed description of the expected difficulty
and (2) a proposed schedule including alternative dates for meeting such requirements on
a step-by-step basis. You must explain any technical or laboratory difficulties and provide
documentation from the laboratory performing the testing. While EPA is considering your
request, the original deadline remains. The Agency will respond to your request in writing.
If EPA does not grant your request, the original deadline remains. Normally, extensions can
be requested only in cases of extraordinary testing problems beyond the expectation or
control of the registrant.  Extensions will not be given in submitting the 90-day responses.
Extensions will not be considered if the request for extension is not made in a timely
fashion; in no event shall an extension request be considered if it is submitted at or after the
lapse of the subject deadline.
                                   169

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                                                                                   ililiJIlKIl
liJIIll^        Hill Ilil	ill llil ii'lillliiiilllllll	••   	Ill	II	ll1 I ' I III lill III	nil II 111	I III III Illllli (I'111 II'I1 II llllllllll'llll	Ill
    iiiii in i illiiinn in  iiiii n in in i iiiiiiiiinnnii nil iiiii mi nnnnini  nil  n  n   n in ill niiiiini n n in n i in inn in nil i  in nil mi nil i iniiiiiiiinninn iiiiiiiinii n i i p iniinnnni

   Option 2, Agreement to Share in Cost to Develop Data —
                                                                     Illlllllllili11 iMllllliill iiillNllIM       	Ill I1 hi
                                                                     .LiiiijinliiiiLii	iiuliiil' •„!	IILI iiiiiiiiiiiiiLiiiiinu ,,i nnnliiiu	1111,11
                              If you choose to enter into an agreement to share in the cost of producing the
            III JW      required data but will not be submitting the data yourself, you must provide the name of the
                                 who will be submitting the data. You must also provide EPA with documentary
                    	ft	                    	«	•	a	,	i	.	'	Si	
                       evidence that an agreement has been formed. Such evidence may be your letter offering to
                    j^foin in an agreement and the other  registrar's acceptance of your offer,  or a written
          	i!,	.i	in	statement by the parties that an agreement exists. The agreement to produce 'the data need
                       not specify all of the terms of the final arrangement between the parties or the mechanism
                                           Section 3 (c)(2)(B) provides that if the parties cannot resolve the terms
!1H^
                       of the agreement they may resolve their differences through binding arbitration.
                          i ll  in n   i                                  ii
                       Option 3. Offer to Share in the Cost of Data Development —
       If you have made an offer to pay in an attempt to enter into an agreement or amend
an" existing agreement to,Ł^Łtjie^re^uirements of this Notice and have been unsuccessful,
 bu may request EPA (by selecting this option) to exercise its discretion not to suspend your
             i, although you do not comply with'the data submission requirements of this
                 determmed that as a general policy, absent other relevant considerations,
              :nd the registration of a product of a registrant who has in good faith sought
                     to	ente,r,	into	a joint data development/cost sharing program, but the
                                                                   "To	qualify	:
                          ion, you must submit documentation to the Agency proving that you have made an of
                     __^o .«g!|j--r jggjkfjajjj ^wgQ jj^ an obligation to submit data) to share in the burden of
                       developing that data. You must also submit to the Agency a completed EPA Form 8570-325
                       Certification of Offer to Cost Share in the Development of Data. In addition, you must
                       demonstrate that the other registrant to whom the offer was made has not accepted your offer
                       to" enter into a cost sharing agreement by including a copy of your offer and proof of the
                       other registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in
                                           else, offer to share in the burden of producing the data upon terms to
                       pe. agreed or failing agreement to be bound by binding arbitration as provided by FIFRA
                            fi,its  econgto d       andsubmit the data required bis Noticeby
                        IjiBmjtting a Data. Sall-in Response Form (Insert  A) and a Requirements Status and
                        .egistrant's Response Form (Insert B) committing to develop and submit the data required
                       by this Notice.

                            —In. order for you to avoid suspension under this option, you may not withdraw your
                       offer to share in the burdens of developing the data.  In addition, the other registrant must
              —"JITHZfuJfill its commitment to develop and submit the data as required by this Notice. If the other
                       registrant fails to develop the data or for some other reason is subject to suspension, your
                       registration as well as that of me other registrant will normally Be subject to initiation of
                       suspension proceedings, unless you commit to submit, and do submit the required data in
                                ilillll'n^^^^^^^^^^^             	„m	    }<7Q	
                       ,,
        fjilil!!!:!' 'Pllllliiif''1^!!!!!!!!!1!?, ".IliiRiilJ II :iil! 111 ..... IlkH, i: '•• , ...... I, nHIVI JII'lII illlMn'L ::i:ii.;::,l;ii!,ll!,||!>ii:lllji|i|!1li;!'!i>,! .1
     [[[ [[[        , .          ,  ,       ,,,>,                          , ,, ..      ,



                                               TV
                                                                           iiii< i i I Ii' ii i<| <<< i «  i in i |i| «r  u'iiii i   i  iiilllllllll ..... i linlllln Illllll 'lililllllll'- lilllllllllMlliilllllllllpllpllllllll i Illllilpllllllililln ' nil'

-------
the specified time frame. In such cases, the Agency generally will not grant a time extension
for submitting the data.

Option 4. Submitting an Existing Study -

       If you choose to submit an existing study  in response to this Notice, you must
determine that the study satisfies the requirements imposed by this Notice. You may only
submit a study that has not been previously submitted to the Agency or previously cited by
anyone. Existing studies are studies which predate issuance of this Notice. Do not use this
option if you are submitting data to upgrade a study. (See Option 5).

       You should be aware that if the Agency determines that the study is not acceptable,
the Agency will require you to comply with this Notice, normally without an extension of
the required date of submission.  The Agency may determine at any time that a study is not
valid and needs to be repeated.

       To meet the requirements of the DCI Notice  for submitting an existing study, all of
the following three criteria must be clearly met:

       a.     You must certify at the time that the existing study is submitted that the raw
       data and specimens from the study are available for audit and review and you must
       identify where they are available.  This must be done  in accordance with the
       requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160.
       As stated  in 40 CFR 160.3(7) " raw data means any laboratory worksheets, records,
       memoranda, notes, or exact copies thereof, that are the result of original observations
       and activities of a study and are necessary for the reconstruction and evaluation of
       the report of that study.  In the event that exact transcripts of raw data have been
       prepared  (e.g., tapes which have been transcribed verbatim, dated,  and verified
       accurate by signature), the exact copy or exact transcript may be substituted for the
       original source as raw data.  Raw data may include  photographs, microfilm or
       microfiche  copies, computer printouts, magnetic media, including  dictated
       observations,  and  recorded  data from  automated  instruments."    The term
       "specimens", according to 40 CFR 160.3(7), means "any material derived from a test
       system for examination or analysis."

       b.     Health and safety studies completed  after May 1984 must also contain all
       GLP-required quality  assurance and quality control information, pursuant to the
       requirements of 40 CFR Part  160.  Registrants must also certify at the time of
       submitting the existing study that such GLP information is available for post-May
       1984 studies by including an appropriate statement on or attached  to the study
       signed by an authorized official or representative of the registrant.

       c.     You must certify that each study fulfills the  acceptance criteria for the
       Guideline relevant to the study provided in the FIFRA Accelerated Reregistration

                                  171

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                          I	Ill	I	I	I	I	I	I	I	                      I	IIIIIIIIIIIIII	Illlllllll	
                                                                                    	I	Ill	niiiii|H|ii||l	|ji	II	


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• 	IIIIIIIIIIIIII^     	!(•    	)•
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                                                           tidtnattne	study h'as	Ee'e^'cOT^rteiS'accordi'n'g'to'tiGle	
                                                     Guidelines (PAG) or meets  the purpose of the PAG (both
                             •ii	available	from	iNTIS).  A study "not	condTicte?	according	to	lie"	p'XS' may	be	
                               submitted to tfie"A"gency	for	consTdera^oli	IFtKe	reglitraijt	Believes	tKat'fEe	study	
                               clearly meets the purpose of the PAG. The registrant is referred to 40 CFR 158170
                               which states the Agency's policy regarding acceptable protocols. If you wish to
                               submit the study, you must^ in addition to certifying that the purposes oFthe FSG"
                             maregjetby the stu^j'clearly"articulate tHe rationale wjiy you believe the study meets
                               the purpose of the PAG, Chiding'copies of any supporting information or data. It
                               has been the Agency's experience that sfudies completed prior to January 1970 rarely
                               satisfied the purpose of the PAG and that necessary raw data are usually not available
                               for such studies.
                                      lf^ you submit an existing study, you must certify that the study meets all
                               requirements of the criteria outlined above.
lip  ..... i
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                               as part of your certification, the manner in which all Agency comments, concerns,
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                               or issues were addressed in the final protocol and study.
                             IIIIIIIIIIIIII 'ii!ll•
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                                      If you know of a study pertaining to any requirement in this Notice which
                               does not meet the criteria outlined above but does contain factual information
                               regarding unreasonable adverse effects, you must notify the Agency of such a sgJ3y.
                               If such a study is hi the Agency's files, you need only cite  it along with the
                               ^OufJllggjjggj	IŁssiiJSt,l!iSiii»iI™S'2 ,™e,2z, Z°,u, 2!™!i 5H™,™ SMH^^Sf f3^ C°P™, —
                               required by PR Notice 86-5.
                        Option 5, Upgrading a Study
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                               If a study has been classified as partially acceptable and upgrade able", youmay submit
                        data to upgrade th^FstudyTThe Agency willlrevievrme"dalasuraEutted and determine if the
                        requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still
                        be required to submit new data normally  without any time extension.  Deficient, but
                        upgradeable	studies	wiff normally	b^e'classilieS'as supplemental	However,	if is important
                        to note that noTalTstudTes	class^^^'suppieniiental	areupgraSeaBle!	If you have q-^e"s|jio^
                        regarding the classification of a study or whether a study may be upgraded, call or write the
                        CQnlacf person listed in Attachment 1.  if you submit data to upgrade an existing study you
                                               •ly articulated rationale of how the deficiencies have been remedied
                ^^^^._^_j_g_^j ^^ wj^y ^ ^^y shouid be rated as acceptable to EPA. Your submission must
                        also specify the MRID number(s) of the study wliich you are attempting to upgrade and must
                        be in conformance with PR Notice 86-5.
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              Do not submit additional data for the purpose of upgrading a study classified as
       unacceptable and determined by the Agency as not capable of being upgraded.

              This option should also be used to cite data that has been previously submitted to
       upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID
       number of the data submission as well as the MRID number of the study being upgraded.

              The criteria for submitting an existing study, as specified in Option 4 above, apply
       to all data submissions intended to upgrade studies. Additionally your submission of data
       intended to upgrade studies must be accompanied by a certification that you comply with
       each of those criteria as well as a certification regarding protocol compliance with Agency
       requirements.

       Option 6. Citing Existing Studies —

              If you choose to cite a study that has been previously submitted to EPA, that study
       must have been previously classified by EPA as acceptable or it must be a study which has
       not yet been reviewed by the Agency. Acceptable toxicology studies generally will have
       been classified as "core-guideline" or "core minimum." For ecological effects studies, the
       classification generally  would be  a rating of "core."   For  all  other disciplines the
       classification would be  "acceptable."  With respect to any studies for which you wish to
       select this option you must provide the MRID number of the study you are citing and, if the
       study has been reviewed by the Agency, you must provide the Agency's classification of the
       study.

              If you are citing  a study of which you are not the original data submitter, you must
       submit a completed copy of Certification with Respect to Citations of Data (in PR Notice
       98-5) EPA Form 8570-34 .

D.     REQUESTS FOR DATA WAIVERS

       There are two types of data waiver responses to this Notice.  The first is a request for a low
volume/minor use waiver and the second is a waiver request based on your belief that the data
requirements) are inapplicable and do not apply to your product.

       !•     Low Volume/Minor Use Waiver -  Option 8 on the Requirements Status and
    .   Registrant's Response Form (Insert B).  Section 3(c)(2)(A) of FIFRA requires EPA to
       consider the appropriateness of requiring data for low volume, minor use pesticides.  In
       implementing this provision EPA considers as low volume pesticides only those active
       ingredient(s) whose  total production  volume for all pesticide registrants is small.   In
       determining whether to grant a low volume, minor use waiver the Agency will consider the
       extent, pattern and volume of use, the economic incentive to conduct  the testing, the
       importance of the pesticide, and the exposure and risk from use of the pesticide. If an active
       ingredient(s) is used for both high volume and low volume uses, a low volume exemption

                                         173

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                            	'	""" ™	I	"•	!	"	'	|	"'"	"|	'	'""	'	"	!	'	"	"	'"	|	"! "'i'"1'"
                  .  If all uses of an active ingredient(s) are low volume and the combined
 B^urne^	laral!	uses.	are	also,	low^Jhen	an exemption may be granted, depending on review
  ^oiŁei,,,,ir3o,rmationi	2u|flie3|5elow.	Jnexenjption will not be grante3 if any registrant of
               !ent(s)	elects'to'	conSuctthetestingT	AnyTegTstoantreceiv'ing a low volume	
                                        i figures in their forecast supporting the waiver
request in order to remain qualified for such waiver.  If granted a waiver, a registrant will be
required, as a condition of the waiver, to submit annual sales reports.  The Agency will
     rid to requests for waivers in writing.
       To apply for a low
;	infQimation2iias	ap|
                                ^	minor use"	wHverj	you	must	suBmit	fhe	foflowmg	
                                       , a,s.Ł?!? °f       "a  e°nse *° ^s Notice:
    I?T9'foreign sales for those products that are not registered in this country but are applied
    IlSjJo	sugar "(cane or beel^'colfee, bananas, cocoa, and other "such crops.  Present the
       above information by year for each of the past five years.
     ~i:b.	Provide	an,	estimate	of	the	sales	(pounds and dollars) of the active
                   jor eac^ m^or use s}te_ p'resent'the above information by year for each
       c'.     Total direct production cost of product(s) containing the active ingredient(s)
   *'iH.by year for the past five years. Include information on raw material cost, direct labor
   	adVertising, Sales an3 marketing, an3 any otEer  significant costs  lis
            lely:	
                                     cost(egpantovernead
       past five years. Exclude all non-recurring costs that were directly relate3 to the
     ^active|ngredient(s), such as costs of initial registration and any data development.
      "5	
    'Ss^^^^^^^ss^^^^ssi^^^^°]L'^^^.y2u?ef^i
       8f	waiver sought and the estimated cost to you (listed separately for each data
            •ement i
ri~^f'	A JisJ^of each data requirement for which you are not seeking any waiver and
       the estimated cost to you (listed separately for each data requirement and associated
       test:) of conducting the testing needed to fulfill each of these data requirements.
 	i	U
                                                               "f     "•        ,, 	  ••'Ł• ;'
                                                               	::	::	-	™	W	?	:	ft"	*	:	
              For each of the next ten years, a .y.ej^'^y'ye^, ^S1,6,™* ,2^ c?mŁanX sa^es
                           ^^.^^»^._^^^^^^«^^^^««.^,^y«^--^^

    :-rcontaining the active ingcedlent(s5	^foTIowTog	!5e	parameters	in	'item	c

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              indirect production costs of produces) containing the active ingredient(s) (following
              the parameters in item d above), and costs of data development pertaining to the
              active ingredient(s).

              h.     A description  of the importance  and unique  benefits  of the active
              ingredient(s) to users. Discuss the use patterns and the effectiveness of the active
              ingredients) relative to registered alternative chemicals and non-chemical control
              strategies.   Focus on benefits  unique to the active ingredient(s), providing
              information that is as quantitative as possible.  If you do not have quantitative data
              upon which to base your estimates, then present the reasoning used to derive your
              estimates.  To assist the Agency in determining the degree of importance of the
              active ingredient(s) in terms of its benefits, you should provide information on any
              of the following factors, as applicable to your product(s):

                     (1)     documentation of the  usefulness of the active ingredient(s)  in
              Integrated Pest Management, (b) description of the beneficial impacts on the
              environment of use  of the active  ingredient(s),  as opposed to its registered
              alternatives, (c) information on the breakdown of the active ingredient(s) after use
              and on its persistence hi the  environment, and (d) description of its usefulness
              against a pest(s) of public health significance.

       Failure to submit sufficient information for the Agency to make a determination regarding
a request for a low volume minor use waiver will result in denial of the request for a waiver.

       2-     Request for Waiver of Data -Option 9 on the Requirements Status and Registrant's
       Response Form (Insert B). This option may be used if you believe that a particular data
       requirement should not apply because the corresponding use is no longer registered or the
       requirement is inappropriate.  You must submit a rationale explaining why you believe the
       data requirements should not apply.  You must also submit the current label(s) of your
       produces) and, if a current copy of your Confidential Statement of Formula is not already
       on file you must submit a current copy.

             You will be informed of the Agency's decision hi writing. If the Agency determines
       that the data requirements of this Notice do not apply to your product(s), you will not be
       required to supply the data pursuant to section 3(c)(2)(B). If EPA determines that the data
       are required for your productfsX you must choose a method of meeting the requirements of
       this Notice within the time frame provided by this Notice. Within 30 days of your receipt
       of the Agency's written decision,  you must submit a revised Requirements Status  and
       Registrant's Response Form (Insert B) indicating the option chosen.
                                         175

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                                                                                   T"
               IV.
                        CONSEQUENCES OFFAILURE TO COMPLY WITH THIS NOTICE
                        NOTICE OF INTENT TO SUSPEND
                             liinnninnniniiiiiiiiii'ijriiiiiiiH                                                                 	liiiuit iiij^iiiiiiiEiiiiiiiiwiii
                             Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
                 failure by a registrant to comply with the requirements of this Data Call-in.Notice, pursuant to
                 FJFJRA sggtion,3(c)(2)(B)  Events which may be the basis for issuance of a Notice of Intent to
                 Suspend include, but are not limited to, the following:
             IIIIIIM^^
                                                                                                    jii"' jiiiiuii	iniii
                                	111::!!^ 	tllin^^^ 	< lilllll	
                                j ailure, torespond as required by this Notice within 90 days of your receipt of this
                                 lotice.
                                                                      ,,,,_,
                                                                                 "                  ""

                              :	-when such is required to be submitted to the Agency for review.
  ......... ; ........... :l .......................... . .............. : ........................................... i: ......... : .......................... ;;; ......................................... gi ....................................... , ....... Fjlliise Ja, ..... ^^itŁaAe_^f^uired schedule an adequate progress report on" a study        I
         ' ..... '! ..... ii ...... 'J      '                                      "
                                                                  schedule acceptable data as required by this

                        5.      failure to take a required action or submit adequate information pertaining to any
                                option chosen to address  the  data requirements  (e.g., any  required action or
                                illformation pertaining to submission or citation  of existing studies or offers,
                                             	OT arSSraEorf on" the	"^^ng oFcosts b'rtfie formation of Taslc Forces,
            	i
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                            I~MJmetftŁ2mply with the terms of an agreement or arbitration concerning joint data
                            |;^Ł'^gJ(^gpiD^t or failure to comply with any terms of a data waiver).
                       	§:
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                                7ailure to submit supportable certifications as to the conditions of submitted studies,
              j,                 5" required*	By	Sec5on"nPC	oFtnis Notice!	
s	'	!	;	'	'	li;i"!l	"'	'	:	!	!	:;:	'	Ł;	:	"	"'	:	:	:::	:	•	;	'"	:	:	;	~	;	r	"	:	:	•	:	;;	:	"••	:	;	-	"="'":	-	'	
±	:	,	:	',:	:
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              c.     otherwise take appropriate steps to meet the requirements stated in this
              Notice, unless you commit to submit and do submit the required data in the specified
              time frame.

       9.     Failure to take any required or appropriate steps, not mentioned above, at any time
       following the issuance of this Notice.
B.     BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS UNACCEPTABLE

       The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any of the following:

       1.     EPA requirements specified in the Data Call-In Notice or other documents
       incorporated by reference (including, as applicable, EPA Pesticide Assessment Guidelines,
       Data Reporting Guidelines, and  GeneTox Health Effects Test Guidelines) regarding the
       design, conduct, and reporting of required studies.  Such requirements include, but are not
       limited to, those relating to test material, test procedures, selection of species, number of
       animals, sex and distribution of animals, dose and effect levels to be tested or attained,
       duration of test, and, as applicable, Good Laboratory Practices.

       2.     EPA requirements regarding the submission of protocols, including the incorporation
       of any changes required by the Agency following review.

       3.     EPA requirements regarding the reporting of data, including the manner of reporting,
       the  completeness of results, and the adequacy of any required supporting  (or raw) data,
       including, but not limited to, requirements referenced or included in this Notice or contained
       in PR 86-5. All studies must be submitted in the form of a final report; a preliminary report
       will not be considered to fulfill the submission requirement.

C.     EXISTING STOCKS OF SUSPENDED OR CANCELED PRODUCTS

       EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide  product which has been suspended or canceled if doing so would be consistent with
the purposes of the Federal Insecticide, Fungicide, and Rodenticide Act.

       The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not
be consistent  with the Act's  purposes. Accordingly, the Agency anticipates granting registrants
permission  to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of clearly
demonstrating to EPA that granting such permission would be consistent with the Act. You must

                                        177

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                                                                                  i
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                 also	explain why an "existing stocks" provision is necessary, including a statement of the quantity
   ™" ™''' ^' of existing stocks and your estimate of the time required for their sale, distribution, and use. Unless
                 you meet this burden the Agency will not consider any request pertaining to the continued sale,
                 distribution, or use of your existing stocks after suspension.
                        If you request a voluntary cancellation of your product(s) as a response to this Notice and
  	i	your" product ""is in' full compliance with all Agency requirements, you will have, under most
	|	|	'"' circumstances, one year from the date your 90 day response to this Notice is due, to" sell, distribute,
                or use existing stocks. Normally, the Agency will allow persons other than the registrant such as
             ^Kindppendent distributors, retailers and end users to sell, distribute or use such existing stocks until
  	j	the	stocks	are	exhausted.	Any sale, distnbution or use of stocks of voluntarily canceled pjroducts
                           an active mgredieat(s) for which the Agency has particular risk concerns will be
                  etermined on case-by-case basis.

                       Requests for voluntary cancellation received after the 90 day response period required by
                this Notice will not result in the Agency granting any additional time to sell, distribute, or use
                exsting stocks beyond a year from the date the 90 day response was due unless you demonstrate to
             S^the Agency that you are in full compliance with all Agency requirements, including the requirements
                              Egrexample, ..... ifyoudecide ..... toyŁluntarilv_ ..... cancel ..... yo^rejistratiniOTittis^fore
                a  year study is scheduled to be submitted, all progress reports and other nformation necessary to
                esiaWishJgatyou have been conducting the study in an acceptable and good faith manner must have
                been submitted to the Agency, before EPA will consider granting an existing stocks provision.
                              REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
                              AD VERSE EFFECTS
                                          III          i                     	'                     	)!	
                  figistrants are reminded that FIFRA section 6(a)(2) states that if at any time after a pesticide is
                  ; Jstered" a registrant has additional factual information regarding unreasonable adverse effects on the
                  Ifonment by tEe pesticide, the registrant shall submit the information to the Agency. Registrants
              must notify the Agency of any factual information they have, from whatever source, including but not
             * limited tointerimor preliminary results of studies, regarding unreasonable adverse effects on man or
              the environment This requirement continues as long as the products are registered by the Agency.
             „ i	;;;;,;	;	;	|;	;;	;	;	;	]	; j	;	;;, ,;	;	;	j	;	«	;,;,,;	
             	:	:	•	:	n... ...s	:	:	:	,	 	.:...
              SECTION VI.   INQUIRIES AND RESPONSES TO THIS NOTICE
                If you have any questions regarding the requirements and procedures established by this Notice, call
              the contact person listed in Attachment 1, the Data Call-In Chemical Status Sheet.
                                                                i	
                ^^ _„.„__ _ _^ j|o--ce ^pQjer gjgjj voluntary cancellation requests and generic data exemption
              filajms) must include a completed  Data Call-In Response Form (Insert A) and a  completed
              Requirements Status and Registrant's Response Form (Insert B) and any other documents required by
                                             ed to the, contact person j^en^ge^ jn ^^cfonent i. if the voluntary
^Si^Hi^i,iiTMa^^Usaal	a2-Hiis»-'S1S4-8JulH.W>i	sSs a.mWMJfisrScr J~ H™ ~MM™~~ JJCJLOVJII lucuuncu 111 f\wa»MUKU.i i. ii ill
*• "  ' y ,,,  	| '1  ',''",',, '",	,':u "'	:	 	j	'"	  \	"..'"	-	'	~.	•	              ',.,.,..  .     !
                                             	
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cancellation or generic data exemption option is chosen, only the Data Call-in Response Form (Insert
A) need be submitted.

  The Office of Compliance (OC) of the Office of Enforcement and Compliance Assurance (OECA),
EPA, will be monitoring the data being generated in response to this Notice.
                                          Sincerely yo
                                          Special Review
                                           Reregistration
Division
                                         179

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-------
 CAPTAN DATA CALL-IN CHEMICAL STATUS SHEET

 INTRODUCTION

  You have been sent this Generic Data Call-In Notice because you have product(s) containing
 captan.
      Generic Data Call-in Chemical Status Sheet, contains an overview of data required by this
notice, and point of contact for inquiries pertaining to the reregistration of captan. This attachment
is to be used in conjunction with (1) the Generic Data Call-In Notice, (2) the Generic Data Call-In
Response Form (Attachment 2), (3) the Requirements Status and Registrant's Form (Attachment 2),
(4) a list of registrants receiving this DCI (Attachment 4),  (5) the EPA Acceptance Criteria
(Attachment 5), and (6) the Cost Share and Data Compensation Forms in replying to this Captan
Generic Data Call In (Attachment F). Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE
  The additional data requirements needed to complete the generic database for captan are contained
i*1 me Requirements Status and Registrant's Response. Attachment C. The Agency has concluded
that additional product chemistry data on captan are needed. These data are needed to fully complete
the reregistration of all eligible captan products.

INQUIRIES AND RESPONSES TO THIS NOTICE

  If you have any questions regarding the generic data requirements and procedures established by
this Notice, please contact Kylie Rothwell at (703) 308-8055.

  All responses to this Notice for the generic data requirements should be submitted to:

        Kylie Rothwell, Chemical Review Manager
        Special Review and Registration Division (7508C)
        Office of Pesticide Programs
        U.S. Environmental Protection Agency
        Washington, D.C. 20460
        RE: Captan
                                        181

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                                         iivn iiiii1	»	in iiiiiiiiiiiii' iiiiiiiii iiiiiiiiiin iiiiini, iiiiiiiiiiiiiiiiin'	i	iiiiiiiiiiiiii	iiiiiiiiif'iini'iiii in iiiiiii'iiiiiiiiiiiiiiiii piiiiiin 11 iiiiiiuf IH ,iii'. n nuiim i111, 'yiiiiiiin iii'i11 111  'ni	in;	miii!11 iiiiiiiiiiiiwi iiiiilliliiiiii'i iiiiii'ii	in!« ii" I
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                             	FORTHE GENERIC	DATA CALL-IN ^RESPONSE FORM  , |


                This Form is designed to be used to respond to call-ins for generic and product specific data for the
                1	'	'	:	'	'	:	'	'	!	"	'	!	'	!	•	"	*	=	s	'	=	"	!	rf	"	°	L	=	'	:F!I	
                  	this	form each time you are responding to a data call-m for WI3CE' 'EPA has sent you the form
         [™:^Mtied	"Requirements Status and Registrant's Response."
                                                                                              I'1"!!1!	!!'"' mS"'111!!1'!!!1!	I!'1'" „ .'n1!!11!!!!1!!!!.',!'!' l!lli"!llll;!"'ll'!!lH!
                                                                                              iiiS^
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                Items1-4 will have been preprinted on the form Items 5 tErbugE 7"'must be completed'b~ythe
                   istanTas'"appropriate'Items	? mrougETTmust be mpTetec[ gy me" JŁgiŁtrant ^g^g su|5mitting
                                         'IIIIH^^^                 lin^^^^	JIIIIIH^^^^	IlilllllU	          . |,!UI 'illlH^^
                                         collection of information is estimated to average 15 minutes per
                     ;c reporting burden for
              p—1||:	'IgJu^Jg'lJjjJg	gjj. reviewing instructions, searching existing data sources, gathering and
              Maintaining the data needed, and completing and reviewing the collection of information.  Send
              .'coTnments	"***garc!ing  tEe b"ur3en estimate or any otner aspect of this collection of information,
              including suggesting for reducing this burden, to Chief, Information Policy Branch, PM-223, U S
                                                , 401 M St, S W, Washington, D C 20460; and to the Office of
              Management and Budget, Paperwork Reduction Project 2070-0107, Washington, D C 20503.
                          is item identifies your company name, number and address
                          !•              	i •iii' i in inn  < n	iii 11 nil inn iiiiiii* p i	tmm\ iiiiiiiii • ii1 iiH  11 iii
                                      i        I                                in
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	,	 	iinniiH^              in inn nil n inn i in in iiiniiiiiiiiiiiiiiiw in in inn in niiiniiiiiniiiiiiiiiiiiinniii iilliiiinniinnn in niiiiiiiiiiiiinn inn iiiiiiiiiinnni 1111 inn iiiiiiiiiiiiiiiiiiiniiiiiiiniiiiiiiiiiiii|iiiiiiinln in iniiiniiliiiiiiiiinn nn in iiiiinn mi in linn nn in
          Item 2. This item identifies the ease number, ease name, EPA chemical number and chemical name.
i iiiii ii i ii
„._,_.„ ™-_ p |—m ^'jjjjs jtem identifies the date and type of data call-in.
                                                                                               up"!
                Item 4/This
                                                  luct registrations relevant to the data call-in. Please note
                      z :,|ha|iyou are also responsible for irrforming the Agency of your response regarding any
                       product that you believe may be covered by this data call-in but that is not listed by the
                                Ia Item 4. You must bring any such apparent omission to the Agency's attention
                                            uired' ?or submission of t

             	1	•	•
                 registration number is listed for a product for which* you previously requested^ voluntary
                 canceSation, indicate in Item 5 the date 01 tEat request  You do not need to complete any
  |^^^^^^^^   iili IsiisSiESesQi	QIJ ,,the	Requirements status an3 SJegistonFs	g^p"o'n"s"e"	p™—	^ g^y pr~ ^^ |ggj ^
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-------
 Item 6b.
 Item 6a.       Check this item if this data call-in is for generic data as indicated in Item 3 and if
               you are eligible for a Generic Data Exemption for the chemical listed in Item 2 and
               used in the subject product. By electing this exemption, you agree to the terms and
               conditions of a Generic Data Exemption as explained in the Data Call-in Notice.

               If you  are eligible for or claim a Generic  Data Exemption, enter the EPA
               registration Number of each registered source of that active ingredient that you use
               in your product.

               Typically, if you purchase an EPA-registered product from one or more other
               producers (who, with respect to the incorporated product, are in compliance with
               this and-any other outstanding Data Call-in Notice), and incorporate that product
               into  all your products, you may complete this item for all products listed on this
               form If, however,  you produce the  active  ingredient yourself, or  use  any
               unregistered product (regardless of the fact that some of your sources are
               registered), you may not claim a Generic Data Exemption and you may not select
               this item.

               Check this Item if the data call-in is a generic data call-in as indicated in Item 3 and
               if you are agreeing to satisfy the generic data requirements of this data call-in.
              Attach the Requirements Status and Registrant's Response Form (Insert A) that
              indicates how you will satisfy those requirements.

              Check this item if this call-in if a data call-in as indicated in Item 3 fora
              manufacturing use product (MUP), and if your product is a manufacturing use
              product for which  you agree  to  supply  product-specific data.  Attach  the
              Requirements Status and Registrants' Response Form (Insert A) that indicates how
              you will satisfy those requirements.

              Check this item if this call-in is a data call-in for an end use product (EUP) as
              indicated in Item 3 and if your product is an end use product for which you agree
              to supply product-specific data. Attach the Requirements Status and Registrant's
              Response Form (Insert A) that indicates how you will satisfy those requirements.

Item 8. Thiscertificationstatementmustbe signed by an authorizedrepresentative of your company
       and the person signing must include his/her title. Additional pages used in your response
       must be initialed and dated in the space provided for the certification.

Item 9. Enter the date of signature.
 Item 7a.
Item 7b.
Item 10.
             Enter the name of the person EPA should contact with questions regarding your
             response.
Item 11.       Enter the phone number of your company contact.
                                         183

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-------
 SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
 REGISTRANTS RESPONSE FORM (INSERT B)

 Generic Data

 This form is designed to be used for registrants to respond to call-in- for generic and product-specific
 data as part of EPA's reregistrationprogram under the Federal Insecticide Fungicide and Rodenticide
 Act. Although the form is the same for both product specific and generic data, instructions for
 completing the forms differ slightly.  Specifically, options for satisfying product specific  data
 requirements do not include (1) deletion of uses or (2) request for a low volume/minor use waiver.
 These instructions are for completion of generic data requirements.

 EPA has developed this form individually for each data call-in addressed to each registrant, and has
 preprinted this form with a number of items. DO NOT use this form for any other active ingredient.

 Items 1 through 8 (inclusive) will have been preprinted on the form. You must complete all other
 items on this form by typing or printing legibly.

 Public reporting burden for this collection of information is estimated to average 30 minutes per
 response, including time for reviewing instructions, searching existing data sources, gathering and
 maintaining the data needed, and completing and reviewing the collection of information. Send
 comments regarding the burden estimate or any  other aspect of this collection of information,
 including suggesting for reducing this burden, to Chief, Information Policy Branch, PM-223, U.S.
 Environmental Protection Agency, 401 M St., SW., Washington, D.C. 20460; and to the Office of
 Management and Budget, Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.

 INSTRUCTIONS

 Item 1.  This item identifies your company name, number, and address.

 Item 2.  This item identifies the case number, case name, EPA chemical number and chemical name.

 Item 3.  This item identifies the date and type of data call-in.
Item 4.
Item 5.
This item identifies the guideline reference numbers of studies required to support the
produces) being reregistered. These guidelines, in addition to requirements specifiedin the
Data Call-in Notice, govern the conduct of the required studies.

This item identifies the study title associated with the guideline reference number and
whether protocols and 1, 2, or 3-year progress reports are required to be submitted in
connection with the study.  As noted in Section III of the Data Call-In Notice, 90-day
progress reports are required for all studies.
                                         185

-------
                             If an asterisk appears in Item 5, EPA has attached information relevant to this
                             guideline reference number to the Requirements Status and Registrant's Response
                             Form (Insert B).
              Item 6.   This item identifies the code associated with the use pattern of the pesticide. A brief
                         I    |   	|||;	I	I'm.. .A	 J-
                       description of each code follows:
                                                                                        smi*	                 I
                                                  Terrestrial non-food

                 tmmm
	I	
                             B.
                             C.
                             D.
                             E.
                             F.
                            	G.
                             H.
                             I.
                             J.
                             K.
                            ,„ L.
                             M.
                             N.
                             O.
Aquatic non-food outdoor
Aquatic non-food industrial
Aquatic non-food residential
Greenhouse food
Greenhouse non-food crop
Forestry
Residential
Indoor food
Indoor non-food
Indoor medical
Indoor residential
             Item 7.  This item identifies the code assigned to the substance that must be used for testing. A brief
                  13E description of each code follows.
                                  HIM^^	Illllll ill III11111 111 111 1111 III III Ililllllll I Illllll IIIIIIIIII ill III ill 11 III  111 111 III Illllll Illllll II 	llil 111  I  III Illlliilllllllillllllilllllllllllllllllil
      	•'	:	'"	<:	"	""'	'""	'	'	•	!•	:	'^3	       End-Use Product
                                                                                                          iiii iiiiii
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                                                  Pure Active Ingredient and Metabolites
                                                  Pure  Active  Ingredient  or  Pure  Active  Ingredient
                                                  ™	" "*	
	:	•	,	•	:	:	,::::	:,:::	,	:	,	•	:	:	::	TEP	*	
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                                                  Pure Active Ingredient Radiolabelled and Metabolites
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                                                  Typical End-Use Product
                                                  Typical  End-Use  Product,  Percent Active Ingredient
                                                  Specified
                                                  Typical End-Use Product or Pure Active Ingjedient and
                                                  Metabolites
                                                        	,	iiiiiinii ••	'i

-------
               TGAI/PAIRA

               TGAI
               TGAI/TEP

               TGAI/PAI
               MET
               IMP
               DEGR
               *See: guideline comment
                     Technical Grade Active Ingredient or Pure Active Ingredient
                     Radiolabelled
                     Technical Grade Active Ingredient
                     Technical Grade Active Ingredient or Typical End-Use
                     Product
                     Technical Grade Active Ingredient or Pure Active Ingredient
                     Metabolites
                     Impurities
                     Degradates
Item 8.   This item identifiesthe time frame allowed for submission of the study or protocol identified
         in item 2. The time frame runs from the date of your receipt of the Data Call-In Notice.

Item 9.   Enter the appropriate Response Code or Codes to show how you intend to comply with
         each data requirement. Brief descriptions of each code follow. The Data Call-In Notice
         contains a fuller description of each of these options.
         1.
        2.
        4.
 (Developing Data) I will conduct a new study and submit it within the time frames
 specified in item 8 above. By indicating that I have chosen this option, I certify that
 I will comply with all the requirements pertaining to the conditions for submittal of
 this study as outlined in the Data Call-in Notice and that I will provide the protocol
 and progress reports required in item 5 above.

 (Agreement to Cost Share)  I have entered into an agreement with one or more
 registrants to develop data jointly. By indicating that I have chosen this option, I
 certify that I will comply with all the requirements pertaining to sharing in the cost
 of developing data as outlined in the Data Call-In Notice.

 (Offer to Cost Share) I have made an offer to enter into an agreement with one or
 more registrants to develop data jointly.  I am submitting a copy of the form
 "Certification of Offer to Cost Share in the Development of Data" that describes this
 offer/agreement. By indicating that I have chosen this option, I certify that I will
 comply with all the requirements pertaining to making an offer to share in the cost
 of developing data as outlined in the Data Call-In Notice.

 (Submitting Existing Data) I am submitting an existing study that has never before
been submitted to EPA. By indicating that I have chosen this option, I certify that
this study meets all the requirements pertaining to the conditions for submittal of
existing data outlined in the Data Call-In Notice and I have attached the needed
supporting information along with this response.

(Upgrading a Study) I am submitting or citing data to upgrade a study that EPA has
classified as partially acceptable and potentially upgradeable. By indicating that I
                                         187

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ivi' ii ill ill ill iii|iiiiiiiii|iiiiih 11 ill iiii iv v iiiiiiiii in viiiiiiiiiiiiiiViiiiiiiivvvivii 111111
        ••i
1^                    	11111 IIIIIII	lilH     	Ill	•illlllH    	1	till	1^         	lllllli llllllilllll         	Ill	ll»^^^^^        	1111
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                           have chosen this option, I certify that I have met all the requirements pertaining to

                           the 9onditions for submitting or citing existing data to upgrade a study described in

                              :	Date	Call-in	Notice.	I	am	indicating on atgcgeg correspondence the Master
                                                                                         data that I am
                                 ; as well as the MRID of the study I am attempting to upgrade.

                               lllllll lllllIB                          	IIIIH^^^^^^^^^          lllllllH
                                                                                             II i ii||llll llllllilllll III Illll
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                           (Citing a Study) I am citing an existing study that has been previously classified by
                                                                                                        ii Ililliilli i 1 II Ii
                                '. as aj.pgptgjig^ core^ cOre niinimum, or a study that has not yet been reviewed

             WIWffmBHB^Y^:?^!ź^^?	^^^i^S^^^^^^?^^^*^0^0^6 ^^y-
in^^^^^^^^	iin               _            .^	,    ^     ,     ,    .     s    .^   r	,	i:	  ;	„
                    7.     (Deleting tJses)_ I am attaching an application for amendment to my registration
                                      i	uses for w|jc|^ggiiiga|a'	arereqTureH.
                    8.
                (Low Volume/Minor'Use^Waiver Request) I have read the statements concerning
                ;=Iow volume-minor	use	3ata	waivers in the J5ata C'aTI-In.^pfice an3 I request a
                '•low-VQlume minor use waiyer of the data requirement. ^ I am attaching a >"
                                       to support this waiver request including, among other things, all
                                       required to support "the request. I understand that, unless modified by
       ^•S^SHSS^SSsthe Agency hi ^g^ y^	^^ requirement as stated in the Notice governs.
=^^^^^^      ^ I^^^^S'  •   I. S?Ł3HŁ5!, l°Ł 5^iYŁŁ .Sll?2*3) ^ ^EZH, ŁŁ^t, ,!^Ł fl^*6™^!^, ,?oncźFn?nl1 ^a wa^vers
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                           oasis for S
                                              s, among other things, all information required to "support the
                           feguirement as stated in the Notice governs.


            Item 10. This item must be signed b'y'aii autitiorized representative of your company. The person
                      —__j                  ^ gjjj mus| iniSil and date all otfier pages of this form.
                      	iiiil
           Jltejni 11. Jgnter me date of signature.
                                  '
               i    ••     • •  •  .      ,     -.:.•,      ,        ,, ..... . .
      1 1. En^er the name of the person EPA should contact with questions regarding your response.
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  v**v
    It PBOtfc°
      UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                          WASHINGTON, D.C. 20460
                                                                             OFFICE OF
                                                                       PREVENTION, PESTICIDES
                                                                       AND TOXIC SUBSTANCES
                               DATA CALL-IN NOTICE
 CERTIFIED MAIL
 Dear Sir or Madam:
 This Notice requires you and other registrants of pesticide products containing the active
 ingredient identified in Attachment 1 of this Notice, the Data Call-in Chemical Status Sheet, to
 submit certain product specific data as noted herein to the U.S. Environmental Protection Agency
 (EPA, the Agency).  These data are necessary to maintain the continued registration ofyour
 product(s) containing this active ingredient.  Within 90 days after you receive this Notice you must
 respond as set forth in Section III below. Your response must state:
       1.
       2.
       3.
How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 5; or

Why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Requirements Status and Registrant's Response Form, (see section
m-B); or

Why you believe EPA should not require your submission of product specific data
in the manner specified by this Notice (see section III-D).
       If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with
its requirements or should be exempt or excused from doing so, then the registration of your
produces) subject to this Notice will be subject to suspension.  We have provided a list of all of
your products subject to this Notice in Attachment 2, Data Call-in Response Form, as well as a list
of all registrants who were sent this Notice (Attachment 5).

       The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
                                          191

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         	Ill	
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                                                                     i         I                      il
                    g|iiiniiiiiiiiiiiiiiiniiiiiiiiiii|iiiiini               ni ill iiiiiii mi ill ii ii iiinniiiiiivunnniinnigninniiiiinnnnni mil ii|i  nin inn ininiin in iiiiiii||iiiiin||iinn||ninn iiiiiiiiiiiiiiiiiniiigniii iniiiwi||iii 11 inn i  in nil i inn nil in in « MM iiini niiiiiniiiiniiiiiiiiiiiini
                    ij	authorized	underthe	Paperwork Reduction Act by OMB Approval No. 2070-0107
             S^HBiffl7Sp™^°™	^	5551-99).

                This Notice is divided into six sections and six Attachments.  The Notice itself contains
         information and instructions applicable to all Data Call-In Notices. The Attachments contain
         Specific chemical information and instructions. The six sections of the Notice are:

                Section 1  -   Why You Are Receiving This Notice
                Section II -    Data Required By This Notice
                Section III-    Compliance With Requirements Of This Notice
                Section IV -   Consequences Of Failure To Comply With This Notice
                Section V -    Registrants' Obligation To Report Possible Unreasonable Adverse
 nil   	Ill	IIIH^^^^^^	IB 	II	I	Effects                                          (
                Section VI -   Inquiries And Responses To This Notice

	!	I	The Attachments to this Notice are:
                                                                                                            ii|l||llllll||||illlillliillinilll
              i        *  -
                     2-
    	|	3  _
    	4  -
                     5  -
                       Data Call-In Chemical Status Sheet
                       Product-Specific Data Call-In Response Form (Insert A)
                       Requirements Status and Registrant's Response Form (Insert B)
                       EPA Batching of End-Use Products for Meeting Acute Toxicology Data
                       Requirements for Reregistration
                       List of Registrants Receiving This Notice

              SECTION I.  WHY YOU ARE RECEIVING THIS NOTICE
              I              r   •""""     : """ "               ""

                     The Agency has reviewed existing data for this active ingredient and reevaluated the data
              needed to support continued registration of the subject active ingredient. The Agency has
              concluded that the only additional data necessary are product specific data. No additional generic
              data requirements are being imposed.  You have been sent this Notice because you have product(s)
              containing the subject active ingredient.

              SECTION n. DATA REQUIRED BY THIS NOTICE
                         i"  —i	i—              i    i         T

                     H-A.  DATA REQUIRED
                         product specific data required by this Notice are specified in Attachment 3, Requirements
              Status and Registrant's Response Form (Insert B). Depending on the results of the studies required in
              this Notice, additional testing may be required.
                            1  I ......
                     H-B,  SCHEDULE FOR SUBMISSION OF DATA
     iiiiiiiiiiiiii iiiiiiiiiiiiii
                are required to submit the data or otherwise satisfy the data requirements specified in Insert B,
         Requirements Status and Registrant's Response Form (Insert BX within the time frames provided.
         iWII!^
I
                                       iriw^               	in
                                    	109
                                    IIM^^^     	        17^
                                                                                   .If'Si
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-------
       H-C.  TESTING PROTOCOL

          All studies required under this Notice must be conducted in accordance with test standards
       outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have
       been established.

              These EPA Guidelines are available from the National Technical Information Service
       (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-605-6000).

              Protocols approved by the Organization for Economic Cooperation and Development
       (OECD) are also acceptable if the OECD-recommended test standards conform to those
       specified in the Pesticide Data Requirements regulation (40 CFR § 158.70).  When using the
       OECD protocols, they should be modified as appropriate so that the data generated by the
       study will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend
       deadlines for complying with data requirements when the studies were not conducted in
       accordance with acceptable standards. The OECD protocols are available from OECD, 2001
       L Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone
       number 202-785-0350).

              All new studies and proposed protocols submitted in response to this Data Call-in
       Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
       H-D.
REGISTRANTS RECEIVING PREVIOUS SECTION 3(cV2)(B) NOTICES
ISSUED BY THE AGENCY
           Unless otherwise noted herein, this Data Call-In does not in anv way supersede or change
       the requirements of anv previous Data Call-InfsX or any other agreements entered into with
       the Agency pertaining to such prior Notice.  Registrants must comply with the requirements of
       all Notices to avoid issuance of a Notice of Intent to Suspend their affected products.

SECTION III.       COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

       DI-A. SCHEDULE FOR RESPONDING TO THE AGENCY

              The appropriate responses initially required by this Notice for product specific data
       must be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
       adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
       Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance
       of NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.


       m-B.  OPTIONS FOR RESPONDING TO THE AGENCY
                                              >i
             The options for responding to this Notice for product specific data are: (a) voluntary
       cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice
       or (c) request a data waiver(s).
                                           193

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                               Illllllltll Pill (111 111
                                                                                iiiiiiiiiii|iiii|iiv     iiiiiiiifiiiiiiii mill	iiiiiiiP'iiiiiiiiii

         ill	!•     	I
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                     uŁsipn	ofhowto	respond if you chose the Voluntary Cancellation option is
         presented below. A discussion of the various options available for satisfying the product
         specific data requirements of this Notice is contained in Section HI-C. A discussion of
         options relating to requests for data waivers is contained in Section III-D.
            I                   '   i                                   L
                There are two forms that accompany this Notice of which, depending upon your
         response, one or both must be used in your response to the Agency.  These forms are the Data-
         Call-in Response Form (Insert A), and the Requirements Status and Registrant's Response
           >rm (Insert B). The Data Call-In Response Form must be submitted as part of every response
         fo tihjs Notige,Xq, addition, one copy of the Requirements  Status and Registrant's Response
         Form (Insert B) must be submitted for each product listed  on the Data Call-In Response Form
         (Insert A)  unless the voluntary cancellation option is selected or unless the product is
         identical to another (refer to the instructions for completing the Data Call-In Response
      ,_ F^prmdnsert A]. Please note that the comgany's authorized representative is required to sign
        I lg*ll!^ ^__	-f"^1	g'gg	'gg||-|g	gg—-gg	I-——	-.|.-.———i	™-|	——y-—-——	———	—|
I
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         Registrant's Response Form (Insert B), initial any subsequent pages. The forms contain
         separate detailed instructions on the response options. Do not alter the printed material. If
         you have questions or need assistance in preparing your response, call or write the contact
         person(s) identified in Attachment 1.

         1.      Voluntary Cancellation - You "may avoid the requirements oFfhls is|o-f}ce by
         requesting voluntary cancellation of your product(s) containing the active ingredient that is
        "" 'me subject	oFtEs	Notice!	IFyjoiTwiIElo1 voluntarily	ci5c"e!	your	product)	you	must	submit a
         completed Data Call-in Response Form (Insert AX indicating your election of this option.
         Voluntary cancellation is item number 5 on the Data Call-in Response Form (Insert B). If you
         choose this option, this is the only  form that you are required to complete.
                     F  I                                     ii                       i,
                 i                                                    i                       n  f
                                                    i                ill                    i
                j(f you chose to voluntarily  cancel your product, further sale and distribution of your
         product after the effective date of cancellation must be in accordance with the Existing Stocks
         provisions of this Notice which are contained in Section IV-C.

         2.      Satisfying the Product Specific Data Requirements of this Notice There are various
         options available to satisfy the product specific data requirements of this Notice.  These
         options are discussed in Section III-C of this Notice and comprise options 1 through 5 on the
         Requirements Status and Registrant's Response Formdnsert A) and item numbers 7a and 7b
         53 trie Data Call-In Response Formdnsert B). Deletion of a use(s) and the low volume/minor
         use option are not valid options for fulfilling product specific data requirements.
                                                                                     	i	ii	
  llilllH
ml	
	1	3.     . Request for Product Specific Data Waivers. Waivers for product specific data are
U         discussed in Section III-D of this Notice and are covered by option 7 on the Requirements
    ii'liiiiillilil Status and Registrant's Response Form (Insert B). If you choose one of these options, you
         must submit both forms as well as any other information/data pertaining to the option chosen
         to address the data requirement.
                                                           194

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 HI-C  SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

        If you acknowledge on the Data Call-in Response Form (Insert A) that you agree to
 satisfy the product specific data requirements (i.e. you select item number 7a or 7b), then you
 must select one of the six options on the Requirements Status and Registrant's Response Form
 (Insert A) related to data production for each data requirement. Your option selection should
 be entered under item number 9, "Registrant Response."  The six options related to data
 production are the first six options discussed under item 9 in the instructions for completing
 the Requirements Status and Registrant's Response Formrinsert AY  These six options are
 listed immediately below with information in parentheses to guide registrants to  additional
 instructions provided in this Section. The options are:

 (1)     I will generate and submit data within the specified time frame (Developing Data)
 (2)     I have entered into an agreement with one or more registrants to develop  data iointlv
        (Cost Sharing)
 (3)     I have made offers to cost-share (Offers to Cost Share)
 (4)     I am submitting an existing study that has not been submitted previously to the
        Agency by anyone (Submitting an Existing Study)
 (5)     I am submitting or citing data to upgrade a study classified by EPA as partially
        acceptable and upgradeable (Upgrading a Study)
 (6)     I am citing an existing study that EPA has classified as acceptable or an existing study
        that has been submitted but not reviewed by the Agency (Citing an Existing Study)

 Option 1, Developing Data - If you choose to develop the required data it must  be in
 conformance with Agency deadlines and with other Agency requirements as referenced here
 in and in the attachments.  All data generated and submitted must comply with the Good
 Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide
 Assessment Guidelines(PAG), and be in conformance with the requirements of PR Notice 86-


       The time frames in the Requirements Status and Registrant's Response Form (Insert A)
 are the time frames that the Agency is allowing for the submission of completed study reports.
 The noted deadlines run from the date of the receipt of this Notice by the registrant. If the
 data are not submitted by the deadline, each registrant is subject to receipt of a Notice of
 Intent to Suspend the affected registration(s).

       If you cannot submit the data/reports to the Agency in the time required by this Notice
 and intend to seek additional time to meet the requirements(s), you must submit a request to
 the Agency which includes: (1) a detailed  description of the expected difficulty and (2) a
 proposed schedule including alternative  dates for meeting such requirements on a step-by-step
 basis. You must explain any technical or laboratory difficulties and provide documentation
 from the laboratory performing the testing. While EPA is considering your request, the
 original deadline remains. The Agency will respond to your request in writing.  If EPA does
 not grant your request, the original deadline remains. Normally, extensions can be requested
 only in cases of extraordinary testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting the 90-day responses. Extensions will
                                     195

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                                                                                    ,      ,,             i
                     not be considered if the request for extension is not made in a timely fashion; in no event shall
                    	an extension request be considered if it is submitted at or after the lapse of the subject
                     deadline.

                     Option 2, Agreement to Sljarem	C"o"st to Develop Data — Registrants'may	only	c"fjo-"0"se	'tEis
,	j	I	' option for acute toxicity data'aHcf	certain efficacy data and only if EPA has indicated	ih'TKe	
                     attached data tables that your product and at least one other product are similar for purposes of
L                     depending on the same data^  If this is the case, data may be generated for just one of the
                     products in the group. The registration number of the product for which data will be
                     submitted must be noted in the agreement to cost share by the registrant selecting this option.
                     If you choose to enter into an agreement to share in the cost of producing the required data but
11 iiiiiiiiiiii i nil in
   ;™;^^::;:'^r^:;:::::S&II	pot	be	submitting the data yourself, you must provide the name of the registrant who will
                     be submitting the data.  You must also provide EPA with documentary evidence that an
                               has been formed.  Such evidence 'may be your letter offering to join in an
                                     '^^S'registranFs	acceptance'	oTyouroBerl	or	a	written	statem eht by the
                        les tEat an agreement exists. The agreement to produce the data need not specify all of the
                         s of the final arrangement between the parties or the mechanism to resolve the terms.
                        •jtipn i^(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they
         mSf.'^SsiSS^	resolve their differences through binding arbitration.
                                                                                             I'll n iinii i iiiiruilii in mini
                     Option 3, Offer to Share in the Cost of Data Development — This option only applies to
            !Ł S3SRSEiŁ|P	toxicity and certain efficacy data as described in option 2 above. If you have made an
                     o,ffer to pay in an attempt to enter into an agreement or amend an existing agreement to meet
                     ~"^requuemente of this Notice and have been unsuccessful, you may request EPA (by
                       lecjing this option) to exercise its discretion not to suspend your registration(s), although
                     ybii donotcomply with the data submission requirements of this Notice. EPA has determined
                     |hat ag a general policy, absent other relevant considerations, it will not suspend the
^^^^^-..'iE^Kjs^^gistration' of a product of a registrant who has in good faith sought and continues to seek to
                     gnl^i:into a joint data development/cost sharing program, but the other registrants)
                     developing the data has refused to accept your offer. To qualify for this option, you must
     ^^^^^j^^suhgjit 'documentation tqjhe Agency proving that you have made an offer to another registrant
            	'	"Iw|o^has an obligation to submit data) to share in tte bjjrden of developing that data. You
                      (Iff also submit to the	Agency a	colnpletecl	EPA"	Fo"rm	8570-32, Certification of Offer to
l^^T^." ..... "^nri==5ijo]st]§hare in the Development of Data, Attachment' 7.  In addition, you must demonstrate that
                    ...... the other registrant to whom the offer was made has not accepted your offer to enter into a
                    [co^shanng agreement by mcludmg a copy of your offer' and proof oFtfie Oth"er registrants
                     receipt of that offer (such as a cerŁgeg maj| receipt).  Your 0|fer must, in a33itibh to
                 ^^Msj^| offer to share in the burden of producing the data upon terms to be agreed or failing
                     agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii)
                         must not qualify this offer.  The other registrant must also inform EPA of its election of
                                       .....   .....
                          'lion to develop	and	submit the	data required "by this Notice by submitting a Data Call-In
                      .esponse Form (Insert A) an9 a Requirements Status and Registrant's Response Form (jnser|
                      ;) committing to develop and submit the data required by Sis ]sjogce
                           	I	ii	,;	;	,	,	.	,	i	,i	i,	i	,i,;i	I.	,	||,,	,	
                            In order for you to avoid suspension under this option, you may not withdraw your
                i===offer to share in the burdens of developing the data. In addition, the other registrant must

-------
 fulfill its commitment to develop and submit the data as required by this Notice.  If the other
 registrant fails to develop the data or for some other reason is subject to suspension, your
 registration as well as that of the other registrant will normally be subject to initiation of
 suspension proceedings, unless you commit to submit, and do submit the required data in the
 specified time frame. In such cases, the Agency generally will not grant a time extension for
 submitting the data.

 Option 4, Submitting an Existing Study - If you choose to submit an existing study in
 response to this Notice, you must determine that the study satisfies the requirements imposed
 by this Notice. You may only submit a study that has not been previously submitted to the
 Agency or previously cited by anyone.  Existing studies are studies which predate issuance of
 this Notice. Do not use this option if you are submitting data to upgrade a study.  (See Option


        You should be aware that if the Agency determines that the study is not acceptable, the
 Agency will require you to comply with this Notice, normally without an extension of the
 required date of submission. The Agency may determine at any time that a study  is not valid
 and needs to be repeated.

        To meet the requirements of the DCI Notice for submitting an existing study, all of
 the following three criteria must be clearly met:
 a.
c.
 You must certify at the time that the existing study is submitted that the raw data and
 specimens from the study are available for audit and review and you must identify
 where they are available. This must be done in accordance with the requirements of
 the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in 40 CFR
 160.3Q) " 'raw data' means any laboratory worksheets, records, memoranda, notes, or
 exact copies thereof, that are the result of original observations and activities of a
 study and are necessary for the reconstruction and evaluation of the report of that
 study. In the event that exact transcripts of raw data have been prepared (e.g., tapes
 which have been transcribed verbatim, dated, and verified accurate by signature), the
 exact copy or exact transcript may be substituted for the original source as raw data.
 'Raw data1 may include photographs, microfilm or microfiche copies, computer
 printouts, magnetic media, including dictated observations, and recorded data from
 automated instruments."  The term "specimens", according to 40 CFR 160.3(k), means
 "any material derived from a test system for examination or analysis."

 Health and safety studies completed after May 1984 must also contain all GLP-
 required quality assurance and quality control information, pursuant to the
 requirements of 40 CFR Part 160.  Registrants must also certify at the time of
 submitting the existing study that such GLP information is available for post-May
 1984 studies by including an appropriate statement on or attached to the study signed
by an authorized official or representative of the registrant.

You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
                                      197

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                             Technical Guidance and that the study has been conducted according to the Pesticide
                             Assessment Guidelines	ŁPAG) ŁŁ meets the gurpose of the PAG (both available from
IS^^^       if iji iji iH^^       nSl i NT? §)"	Asfiidy najj	^orJgucteH	a^c7>n!ing'to	|fj~	p^g may j-,e Sub"mitte3 to tEe Agency
(•^       I1 I'1 I I^HnNHnBll WIGPWM	I*	!	"	  .. j	i	5	-	=	--	—	-a	-	-j	—	3	 J   J  	-	-s	-s-
                             for consideration if the registrant believes that the study clearly meets the purpose of
                             the PAG- The registrant is referred to 40 CFR' 158.70 which stetes'tiwAgency's policy
                             regarSing	acceptable	protocols!	IF you wish to submit the stu3y, you must, in addition
                             to <»r^^mg tf^fteŁU^p^s of^|Pj^'are rnet%^ stady, clearly  articulate the"""
              	|	rationale	:	
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                             any" supporting information or data. It has been the Agency's
                             completed prior to January 1970 rarely satisfied the purpose of the PAG and that
                             necessary raw data are usually not available'for such studies.'
             i • ill1 ii lli1 1 i^^ I
             ....... of the
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                            criteria ..... O"u"gm-e3'
                                         i

                  ............. Jfvou know of a study ^rjaining to any requirement in this Notice which does not
                    ' 'nibetthe c1rj!tBH4 .outlinecl ab"ove"'But ..... Hoes ...... Contain ..... factual information regarHing unreasonable
                      adverse effects, you must notify the Agency of such a study. If such study is in the Agency's
                      files, you need only cite it along with the notification. If not in the Agency's files, you must
                      submit a summary and copies as required by PR Notice 86-5.

                      Option 5, Upgrading a Study — If a study has been classified as partially acceptable and
                          58eab"Ie^ ..... ySumay ...... sublnrt ..... gat5""|0" ...... upgraZeTEat ..... stu3yl ............. TEe ^ggj^y ...... ^gf ^vfgw' the data
                      submitted and determine if the reqiurement is satisfied. If the Agency decides the requirement
                    ................. s     satisfiek you may still be reuired to submit new date normally without any time
                                                           stiiilies will normally be classified as ^supplemental.
          illilillll'il
    iiiiiii i in inn iii
    iiiiiiii
         IIII II IIIIIIII I
         ill	i (h
                      However, it is important to note that not all studies classified as supplemental are
                      upgfideable.  If you have questions regarding the classification of a study or whether a study
                      may be upgraded, call or write the contact person listed in Attachment 1.  If you submit data to
                      upgrade an existing study you must satisfy or supply information to correct all deficiencies in
                      the study identified by EPA.  You must provide a clearly articulated rationale of how the
                      deficiencies have been remedied or corrected and why the study should be rated as acceptable
                      to EPA. Your submission must also specify the ftfRID number(s) ofthe study which you are
                      attempting to upgrade and must be hi conformance with PR Notice 86-5.

                              E)o not submit additional data for the purpose of upgrading a study classified as
                      unacceptable and determined by the Agency as not capable of being upgraded.

                              This option should also be used to cite data that has been previously submitted to
                      upgrade a study,  but has not yet been reviewed by the Agency.  You must provide the MRID
                      number ofthe data submission as well as theMRJDn~^jffifa^^ "fjemg 'upgraded".
              Iiiiiiiiiiii i iiiiiii i nil ii iiiii ill i iiiii in
               111 iiiiiiii iiiiiiiiiiigii ii 111 ii nnnnniiiniiiiiiiii i ii i n n ii n in • ii 111 n ii iiiiiii in in nnllnnniiiiiiii ill ii n • ii ill i in ill ii n in ii i n ill i p i ii ii Hi* i iini Hi iiiiililnil 11 iiiiiii ii iniinni|ii iiiii i iii n iiiiiiiiiii i ii 111  iiiiiiii i iin iiiiiiiiiiii n n n 11111111 in i iiii iii 1111  ii 1111 n in i ill iiiiiiii i HI'
               iiiiliinliini iiiiiiiiiiiiiiii in iiii n n nil in iin iiii n in iiiiiiii in n iii in i iin in i nil n nil iiiiiii i iiiiiiiiiiiiiiiiiiiiiiii iiiini in INI n inn inn iiiiiiiiiiii iin 11111111 iniliiininniiini iiiiiiiiiiiiiiiiiiiiiiiiniiiiiiiiiiiiiiiiiiiiiiiiiiiiiniiiiiiiiliiiiiiiiii ii iii niiiliiiiiiiliiiiiiniiiiiiiiiiifii  iii mi mi nun inn in inn iim ' n iin
               •Willie criteria for submitting  an existing study, as specified in Option 4 above,
            all data submissions intended to upgrade studies. Additionally your submission of data
            intended to  upgrade studies must be accompanied by a certification that you comply with each
                                                              198
              I	M_^^__^_^^_^^^^______


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 of those criteria as well as a certification regarding protocol compliance with Agency
 requirements.

 Option 6. Citing Existing Studies - If you choose to cite a study that has been previously
 submitted to EPA, that study must have been previously classified by EPA as acceptable or it
 must be a study which has not yet been reviewed by the Agency. Acceptable toxicology
 studies generally will have been classified as "core-guideline" or "core minimum."  For all
 other disciplines the classification would be "acceptable." With respect to any studies for
 which you wish to select this option you must provide the MRID number of the study you are
 citing and, if the study has been reviewed by the Agency, you must provide the Agency's
 classification of the study.

        If you are citing a study of which you are not the original data submitter, you must
 submit a completed copy of EPA Form 8570-34, Certification with Respect to Citations of
 Data (in PR Notice 98-5V

        Registrants who select one of the above 6 options must meet all of the requirements
 described in the instructions for completing the Data Call-in Response Form (Insert A) and
 1316 Requirements Status and Registrant's Response Form (Insert B),  as appropriate.

 III-D.  REQUESTS FOR DATA WAIVERS

        If you request a waiver for product specific data because you believe it is
 inappropriate, you must attach a complete justification for the request, including technical
 reasons, data and references to relevant EPA regulations, guidelines or policies.  (Note: any
 supplemental data must be submitted in the format required by PR Notice 86-5).  This will be
 the only, opportunity to state the reasons or provide information in support of your request. If
 the Agency approves your waiver request, you will not be required to supply the data pursuant
 to section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an
 option for meeting the data requirements of this Notice within 30 days of the receipt of the
 Agency's decision. You must indicate and submit the option chosen on the Requirements
 Status and Registrant's Response Form. Product specific data requirements for product
 chemistry, acute toxicity and efficacy (where appropriate) are required for all products and the
 Agency would grant a waiver only under extraordinary circumstances. You should also be
 aware that submitting a waiver request will not automatically extend the due date for the study
 in question. Waiver requests submitted without adequate supporting rationale will be denied
 and the original due date will remain in force.
CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE

IV-A  NOTICE OF INTENT TO SUSPEND
due
   The Agency may issue a Notice of Intent to Suspend products subject to this Notice
to failure by a registrant to comply with the requirements of this Data Call-Tn Notice
                                     199

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  11      I      I	II	I   	I     ill
l,l	I	I	"	I	»	I	I	
                                                       Ill 111 II  I III 11 111  1 111111 111
                      pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice
                                 Suspend include, but are not limited to, the following:
                                                              illEil'liii'iillilllllllll'iiiqiii1!1'!!!!!:!!!!!
                      1.     failure to respond as required by this Notice within 90 days of your receipt of this
                  !!=^^^^^^  	|«^^^^^^^^	'	
                                                                                  	IT	

                  !fiH^^^^^^^^^^^^^
                             	Failure'to	iuB'mTE	ontne	require3	sc^edTHe	an""accepte.B"ie proposed or final protocol
                                                  to Be	suBmitteH	to"tne"Ageney	for review.
                      3.     Failure to submit on the required schedule an adequate progress report on a study as
                             required by this Notice.
                             acceptae
                                                                                              By
                             Łai|ure|o take a required action or submit adequate information pertaining to any
                            5gp_tion chosen to address the data requirements (e.g._, any required action or
                             i|tforrnaBon pertaining to submission or citation of existing studies or offers,
                                           or arbitration on the sharing of costs or the formation of Task Forces,
                                    to comply with the terms of an agreement or arbitration concerning joint data
                             development or failure to comply with any terms of a data waiver).
	issrjsss^ri™1,™	ss; 6.     Failure to submit supportable certifications as to the conditions of submitted studies,
|                  	IIIIIJII	"	,;	in	m	!	«	f	™	w,*3:,__	_	_,_,	_,	,	I	
  •^•MPurjijpyiiHiiif	•!i/i«^^^^^^^	 as required by Section III-C of this Notice.
                      7.     Withdrawal of an offer to share in the cost of developing required data.
                      8.  '"  '"' Failure of the registrant to whom you have tendereS	an 'offer to sEare in tEe cost of
                                                                                             ol^ForJSiIure ...... of ...............................
 on whom you rely for a generic data exemption either to:
  . ........ ;
 rmi
ata' .....
                                     ........ .............................. ........ ............ ............ ............... ..... ; .............. ................................... ................... ............................................. ...... ................ ....... ...................  ....... , ......... ............ ............ .................. ..... ........ ..... ........ ................... ................ .............. ............. ..... ............. ............. ............................. ............ ............................................ ..................................... ............................
                                     ft|brmEiPA of intent to3evelop an"3 suBmit ffie iata^required By this Notice on
                                                           foTmCtnsert^ ...... 553 ..... a"'Riq'uir'e'm'e'nts' ........ status ...... and'
                                    1^         Response Formdnsert B):
                             b.     fulfill the commitment to develop and submit the data as required by this
                                    , T ........... "t ............ i .......... [[[ i  •         •             •  '         <•
                                                                                    i
                             gs     otherwise take appropriate steps to meet the requirements stated in this Notice,
                                   !luriless you commit to submit and do submit the required data hi the specified

-------
 IV-B.  BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
        UNACCEPTABLE

        The Agency may determine that a study (even if submitted within the required time) is
 unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The
 grounds for suspension include, but are not limited to, failure to meet any of the following:

 1.  EPA requirements specified in the Data Call-In Notice or other documents incorporated by
 reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data Reporting
 Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design, conduct, and
 reporting of required studies.  Such requirements include, but are not limited to, those relating
 to test material, test procedures, selection of species, number of animals, sex and distribution
 of animals, dose and effect levels to be tested or attained, duration of test, and, as applicable,
 Good Laboratory Practices.

 2.  EPA requirements regarding the submission of protocols, including the incorporation of
 any changes required by the Agency following review.

 3. EPA requirements regarding the reporting of data, including the manner of reporting, the
 completeness of results, and the adequacy of any required supporting (or raw) data, including,
 but not limited to, requirements referenced or included in this Notice or contained in PR 86-5.
 All studies must be submitted in the form of a final report; a preliminary report will not be
 considered to fulfill the submission requirement.

 r^-C   EXISTING STOCKS OF SUSPENDED OR CANCELED PRODUCTS

        EPA has statutory authority to permit continued sale, distribution and use of existing
 stocks of a pesticide product which has been suspended or canceled if doing so would be
 consistent with the purposes of the Act.

        The Agency has determined that such disposition by registrants of existing stocks for a
 suspended registration when a section 3(c)(2)(B) data request is outstanding would generally
 not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
 registrants permission to sell, distribute, or use existing stocks of suspended product(s) only in
 exceptional circumstances.  If you believe such disposition of existing stocks of your
 product(s) which may be suspended for failure to comply with this Notice should be
 permitted, you have the burden of clearly demonstrating to EPA that granting such permission
 would be consistent with the Act. You must also explain why an "existing stocks" provision is
 necessary, including a statement of the quantity of existing stocks and your estimate of the
 time required for their sale, distribution, and use. Unless you meet this burden the Agency
 will not consider any request pertaining to the continued sale, distribution, or use of your
 existing stocks after suspension.

       If you request a voluntary cancellation of your produces) as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have, under
most circumstances, one year from the date your 90 day response to this Notice is due, to sell,
                                     201

-------
              1                 'II                                          III
          ill 1111111 iiiiiiiiiiiiiiii iiiiiiiiiiiiiiiiii  illiiiiiiiii iiiiiih iiiiiiiiiiiiiiiiiilllliiiiiiiiiiiiiiiiiiiiiiiiiiii in iiiiiiiiiiiiiiiiiii i in ill iiiiiiiiiiiiiiiiiiiiiiiiliiiiii i i in iiiiiiiiiiiiiiiiiiii 1IIII1I1II11 iiiiiiiiiiiiilliiiiiiiiiiliH^           i ill  iiiiiiiii in ni
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 111 IIIIIII 111  ..   .            11MIHIB IIIIIIIIIIIIIIIIIII  Illllllll 111 1111 llllllllllllll Illlllllllllllllllpllllllll 111 llllllllllllll Illllllll Illlllllllllllllllllllll      .      Ill I IIIIIII III II llllllllllllll Illllllll I 111 llllllllllllll IIIIIIIH
        distribute, or use existing stocks. Normally, the Agency will allow persons other than the
        registrant such as independent distributors, retailers and end users to sell, distribute or use
        such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
        Voluntarily canceled products containing an active ingredient for which the Agency has
        particular risk concerns will be determined on case-by-case basis.

                 .equests for voluntary cancellation received after the 90 day response period required
        by this Notice will not result in the Agency granting any additional time to sell, distribute, or
        use existing stocks Beyond a year from the date the 90 day response was due unless you
        demonstrate to the Agency that you are in full compliance with all Agency requirements,
        including the requirements of this Notice. For example, if you decide to voluntarily  cancel
        your registration six months before a 3 year study is scheduled to be submitted, all progress
        reports and other information necessary to establish that you have been conducting the study
        in an  acceptable and good faith manner must have been submitted to the Agency, before EPA
        Vvill consider granting an existing stocks provision.

SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSmLEUNREASONABtE
               ADVERSE EFFECTS
liiij	•	•,	:	j.,111111,1  fl  I            I                Jl                   ,i,                               l!  ,
                  i are reminded that FIFRA section 6(a)(2) states that if at any time after a pesticide
     |istered a registrant has additional factual formation regarding unreasonable adverse effects on
   I	gayjronmenl	By the pesticide, the registrant sh'al| submit th'e inTormaBon to Hie Agency.
                                      1!	II	Ill
                                      i:	'in
               Registrants must notify the Agency of any factual information they have, from whatever source,
               including but not limiteS to interim or preliminary results of studies, regar9ing unreasonable adverse
               effects oilman or the environment.  This requirement continues as long as the products are registered
               "Sy'the Agency.
            	1	
                                mi minium iiliiiiiiiiiiiiiiini in nnnnnninnnlin linn in in nnnnnnnnnnnnnnnnnnnnnninn iiiiipiiiiiiiiiiiiiii i nnnnninn minium i niiiinn nn inn i nn nnnnnnn nnnnnninn i nnnnnnninn iniiiii i inlninn nn illilnnnnnn linn i inn i nnnnnnnnn iniiiii inn linn n nn niiiiniiiiiiiiiiininn i mini i nnnnnnninn 1111111111111 mini i in ininiii i n nnnnnnnnnn i nilnninn linn i mini n i n linn i in i i mini i mini i nlli In i in
                                	                                                  	 i
          -=:	rj	SECTION VLINOUIRIES AND RESPONSES TO THIS NOTICE
                           '
                              All responses to this Notice (other than voluntary cancellation requests and generic
                      data exemption claims) must include a completed Data Call-In Response Form (Insert A) and
                      a completed Requirements Status and Registrant's Response Form (Insert B) for product
                      specific data) and any_ other documents required by this Notice, and should be submitted to
                      the contapt person(s) j^engge^ jn ^^^^^ ^  If the voluntary cancellation or generic data
                      exemption option is chosen, only the Data Call-In Response Form (insert A) need be
                      submitted.
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            in   i
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                                                                        4
            111 'ill	i iii i iiiii1 in	1111 •	1111111

-------
              The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
       Substances (OPTS), EPA, will be monitoring the data being generated in response to this
       Notice.
                                        Sincerely yours,
                                          )is A. Rossi^Director |
                                         Special Review and
                                         Reregistration Division
Attachments
       2 -
       3 _
       4 -

       5 _
Data Call-In Chemical Status Sheet
Product-Specific Data Call-in Response Form (Insert A)
Requirements Status and Registrant's Response Form (Insert B)
EPA Batching of End-Use Products for Meeting Acute Toxicology Data Requirements
for Reregistration
List of Registrants Receiving This Notice
                                          203

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             , .        	"i     •     r  •• -;    • • .  •,,      •. .    v  • .•   •.  1,1,1,.,  •;• -i] 'hi;-1 •           • •   '•:•':;  '' ->•.
                You have been sent this Product Specific Data Call-in Notice because you have product(s) containing
         [""caplll'I	
K'
                 This PlocfiiGt gpecific Data Call-in Chemical Status Sheet contains an overview of data required by
          |H| gfitice, and point of contact lor inquiries pertaining to me reregistration of captan. This attachment is to
          be used in conjunction with (1) the Product Specific Data Call-in Notice, (2) the Product Specific Data Call-in
          T?ftc^nc^Fnrrn f Attachment 7*1^Tthe Requirements Status and Registrant's Form (Attachment3), (4) EPA's
        	>ceplance	^tena^AttecTm^tB^	'(&)	aTisTofliglstrantereci^	'anB"(7jlfieC!ost	
          Share and Data CompensationForms in replying to this Captan Product Specific Data Call-In (Attachment 7).
          Instructions and guidance accompany each form.
         lillllilM^    IIIIIIIIIIIIIIIIH                             III                 III           I    II     I
                                                  iiiiiiiiiiiiiiiii ill iiiiiiiiiiiiiiiiiiiii II i ill ill iiiiiiiiiiiiiiiiiii n IIIIIIIIII1 inn iiii iiiiiiiiiii ill iiiiii i
                                                            	          i      i 	
                                               needTdto	complete' "3ie" datS^e'fpr captan are eontained' in the
        ••^IbBMllTic additional
          Requirements StafasWdR^dstrant'sResponse^ Attachment 3. The Agency has concluded that additional data
 	   .,,_	| ori'ckp'tan are ^^^^'^'^^Si^'p^^^!	TOe^3^aare^req^red" to be submitted to the Agency within the
       	time framelist^T	TEese	dataare'ne'eHed^to	fully~a>mpletetne	^eglsfrationoFIIl eligiblecapf^products.
 ""            i     ,    "'.K. •;:	,:     ••        •       •  'V '    '  ,  • » J    y::;  ' V ' • ;'  :'    ":'"    "     •••'••* ,    'J1' |:!' ;
          INQUIRIES AND RESPONSES TO THIS NOTICE
   I ,                        -                                   II         I                 '                II

                 If you have any questions regarding this product specific data requirements and procedures established
          by mis Notice, please contact Karen Jones at (703) 308-8047.

                 All responses to this Notice for the Product Specific data requirements should be submitted to:
                            i                         »               ,    	i    'j                  «,      ""
                     ''""	chemical R"^ew^5anager Team 81
                        Product Reregistration Branch
      	I1'	Special Review and Reregistration Branch 7508C
    	'"	pffice of Pesticide Programs
                        U.S. Environmental Protection Agency
                        Washington, D.C. 20460

                       ^RELCaptan
                                                                   .
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                             	"	'''	'	"'	'	'	'	'	'	'	'	iiKi.JB^




                                                                                            iiiiia	iiimn
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                                                                                      Ijlllllllllllljlt^^^^^^^^^^^^^^	               I
                .  ,      "•   .,     •...•,..•             ••          .     ^     	|, •   ^	    ,.",'.    >'!'
             i!fc: J«:,	:;

-------
     INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
                                 PRODUCT SPECIFIC DATA
Item 1-4.

Item 5.
Item 6.
Item 7a.
Item7b.
Items 8-11.

NOTE:
 Already completed by EPA.

 If you wish to voluntarily cancel your product, answer "yes." If you choose this option, you
 will not have to provide the data required by the Data Call-In Notice and you will not have to
 complete any other forms. Further sale and distribution of your product after the effective date
 of cancellation must be in accordance with the Existing Stocks provision of the Data Call-In
 Notice (Section IV-C).

 Not applicable since this form calls in product specific data only. However, if your product is
 identical to  another product and you qualify for a data exemption, you must respond with
 "yes" to Item 7a (MUP) or  7B (EUP) on this form, provide the EPA registration numbers
 of your source(s);  you would not complete the "Requirements Status and Registrant's
 Response" form. Examples of such products include repackaged products and Special Local
 Needs (Section 24c) products which are identical to federally registered products.

 For each manufacturing use product (MUP) for which you wish to maintain registration, you
 must agree to satisfy the data requirements by responding "yes."

 For each end use product (EUP) for which you wish to maintain registration, you must agree
 to satisfy the data requirements by responding "yes." If you are requesting a data waiver,
 answer "yes" here; in addition, on the "Requirements Status and Registrant's Response" form
 under Item 9, you must respond with Option 7 (Waiver Request) for each study for which you
 are requesting a waiver. See Item 6 with regard to identical products and data exemptions.

 Self-explanatory.

 You may provide additional information that does not fit on this form in a signed letter that
accompanies this form. For example, you may wish to report that your product has already
been transferred to another company or that you have already voluntarily canceled this product.
For these cases, please supply all relevant details so that EPA can ensure that its records are
correct.
                                             205

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Item 1-3
Item 4.
Item 5.

Item 6.
Item 7.
Item 8.
Item 9  .
INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
  REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA

   Completed by EPA. Note the unique identifier number assigned by EPA in Item 3. This
   number must be used in the transmittal document for any data submissions in response
   to this Data Call-In Notice.

   The guideline reference numbers of studies  required to support the product's continued
   registration are identified. These guidelines, in addition to the requirements specified in the
   Notice, govern the conduct of the required studies. Note that series 61 and 62 in product
   chemistry are now listed under 40 CFR 158.155 through 158.180, Subpart C.

   The study title associated with the guideline reference number is identified.

   The use pattern(s) of the pesticide associated with the product specific requirements is (are)
   identified. For most product specific data requirements, all use patterns are covered by the data
   requirements. In the case of efficacy data, the required studies only pertain to products which
   have the use sites and/or pests indicated.

   The substance to be tested is identified by EPA.  For product specific data, the product as
   formulated for sale and distribution is the test substance, except in rare cases.

   The due date for submission of each study is identified. It is normally based on 8 months after
   issuance of the Reregistration Eligibility Document unless EPA determines that a longer
   tune period is necessary.

  Enter only one of the following response codes for each data requirement to show how
  you intend to comply with the data requirements listed in this table. Fuller descriptions
  of each option are contained in the Data Call-In Notice.

  I will generate and submit data by the specified due date (Developing Data). By indicatingthat
  I have chosen this option, I certify that I will comply with all the requirements pertaining to the
  conditions for submittal of this study as outlined in the Data Call-In Notice. By the specified
  due date, I will also submit: (1) a completed "Certification with Respect to Citations of Data
  (in PR Notice 98-5)" form (EPA Form 8570-34) and (2) two completed and signed copies
  of the Confidential Statement of Formula (EPA Form 8570-4).

  I have entered into an agreement  with one or more registrants to develop data jointly (Cost
  Sharing). I am submitting a copy of this agreement. I understand that this option is available
  only for acute toxicity or certain efficacy data and only if EPA indicates in an attachment to this
  Notice that my product is similar enough to another product to  qualify for this option. I certify
  that another party hi the agreement is committing to submit or provide the required data; if the
  required study is not submitted on time, my product may be subject to suspension. By the
  specified due date, I will also submit:  (1) a completed "Certification with Respect to
                                            207

-------

                      ata(in PR Notice 98-5)" form
                                                                  2) two completed
                                                                                          in iii ill
        ~'^d'''signed:Jcopies	offhe	Confidentiar'StatemeiEt	of^olriEuIa	(EPA	Form	8570:4)"
        i;;; liilii^^   "IliSlSL	_,	t;	:	in	s	i	:„:	i	:	LIII	;;L!	i:	:	;	IEJ:	:	:	u:	1:
                                                                           I	|iil:>:	(I	MI
         I have made offers to share in the cost to dsyelqp data (Offers to Cost ^are) . I understand
                       is available ojnly for acute toxicity or certain efficacy data and only if i ERA
                                                           '
                                                                                      i
            icates in an att^phgLent to this. .Data jCalI;-ln ^fotice th'at my product is similar enough to
                 product to qualify for this option.  I am submitting evidence that I have'made an
         ^flferto another registrant (who has an obligation to submit data) to share in the cost of that
        Idata.  i .am	also	submitting a completed "Certification of Attempt to Enter 'into" an
         Agreement with other Restraints for Development of Data " (EPA Form 8570-32). I am
            [uding a copy of my offer and proof of the other registrant's receipt of that offer. I am
         identifying the party which is committing to submit or provide the required data; if the required
               is not submitted on time, my product may be subject to suspension. I understand that

         Bther terms under Option 3 in the Data CaH-in Notice (Section III-C. 1.) apply as well.  By the
              ^ _^ Łk_^ | ^_ j ^so submit: (1) a complete3 "Certification with Respect To j>ata
         Compensation Requirements" form (EPAForm 8570-34) and (2) two completedand signed
     	copies	of'the	Qrafidenti7d]§tatemeiit	oTF'ormuia	(EFA"	fo"r"jj	jjSTTPfi	
                                                                                          i	iiiiiiiii
 	"41	
 By the specified due date, I will submit an existing study that has not been submitted previously
        :l|giiii;||}e	Agency_by anyone (Submitting an Existing Study). I certify that this study will meet
        . al	ffig Requirements for submittal of existing data outlined in Option 4 in the Data Call-in
  Ipjisp, (Section HI-C.1.) and will meet the attached acceptance criteria (for acute toxicity and
 product chemistry data).  I will attach the needed supporting information along witfi this
     5fi§e" I also certify that I have determined that this study will fill the data requirement for
       ..... jiaye ..... j^jjgatgS^jg ..... choice. ..... .Bv^fe specifiecl Sue Hate, I'wiU 3so submit a coinpjeted
  gg|||15ca,||o:ii ..... Witij ....... Rj^pect To Data"'" Compensation ..... 'Requirements" ....... form .......
=-
 Iwil
                    show wnat data compensation option I have chosen. By the specified due
               also submit:  1 a completed "Certification With Respect To Data Compensation
         Requirements" form (EPA Form 8570-34) and (2) two completed and signed copies of the
             ^|^^,§^|en2^ti^Ł'o^^ai'^PAFoinm'8570-4).'   '"  '  "      	"
                       i	    ,	liiiliiiilli	Ilii 111	IB	!1«          	(illlll|i|	Ill	IlllllB	Ill	ill	               j
              .e ^specified due date, I will submit or icite data to upgrade a study classified by the Agency
               .ally acceptable an3 upgradable {OpgraHing a Study).  I will submit evidence of the
                   eview in3ica5ng that th'e stuHy may be upgra3e3 an3 wEat information is require3
         lo dp"'so.  I will provide the MRID or Accession number of the study at the due date.  I
         understand that the conditions for this option outline3 Option 5 in the Data Call-in Notice
         (Section IH-Cl.)  apply.  By the specified due date, I  will also submit: (1) a completed
"	'	;	'''gertjificatign,With,Respect 'To Data Compensation Requirements" form (EPA Form
      	ill!	i;:^EPAForm;'8570-4).
                                                           in I nil II liiiliiiilli in inn II nil I liiiiiiiiliiiiiiini nil»inn I»I nil»I in nil nil
                                                           III •illlilllllllH^^^^^     	ililllM^
         IIIIIIIIH                                   illlllllllllllllllIM^^^^^^                	ililllM^
         By uie specified due date, I will cite an existing study that the Agency has classified as
                            If I am citing another registrant's study, I understand that this option is
                     y for acute toxicity or certain efficacy data' ancf only if the cited study was


-------
       7.
 conducted on my product, an identical product or a product which EPA has "grouped" with one
 or more other products for purposes of depending on the same data. I may also choose this
 option if I am citing my own data. In either case, I will provide the MRID or Accession
 number(s) for the cited data on a "Product Specific Data Report" form or in a similar format.
 By the specified due date, I will also submit: (1) a completed "Certification With Respect To
 Data Compensation Requirements" form (EPA Form 8570-34) and (2) two completed and
 signed copies of the Confidential Statement of Formula (EPA Form 8570-4).

 I request a waiver for this study because it is inappropriate for my product (Waiver Request).
 I am attaching a complete justification for this request, including technical reasons, data and
 references to relevant EPA regulations, guidelines or policies. [Note: any supplemental data
 must be submitted in the format required by P.R. Notice 86-5]. I understand that this is my
 only opportunity to state the reasons or provide information hi support of my request. If the
 Agency approves my waiver request, I will not be required to supply the data pursuant to
 Section 3(c)(2)(B) of FIFRA. If the Agency denies my waiver request, I must choose a
 method of meeting the data requirements of this Notice by the due date stated by this Notice.
 In this case,  I must, within 30  days of my receipt of the Agency's written decision, submit a
 revised "Requirements Status and Registrant's Response" Form indicating the option chosen.
 I also understand that the deadline for submission of data as specified by the original data call-in
 notice^will not  change.  By the specified due date, I will also submit: (1) a completed
 "Certification With  Respect  To Data Compensation Requirements" form (EPA Form
 8570-34) and (2) two completedand signed copies of the Confidential Statement of Formula
 (EPA Form 8570-4).
Items 10-13. Self-explanatory.
NOTE:
You may provide additional information that does not fit on this form in a signed letter that
accompanies this form.  For example, you may wish to report that your product has already
been transferred to another company or that you have already voluntarily canceled this product.
For these cases, please supply all relevant details so that EPA can ensure that its records are
correct.
                                             209

-------

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-------

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                  EPA'S BATCHING OF CAPTAN PRODUCTS FOR MEETING
             ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION

        In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity data
 requirements for reregistration of products containing the active ingredient Captan the Agency has batched
 products which can be considered similar for purposes of acute toxicity. Factors considered in the sorting
 process include each product's active and inert ingredients (identity, percent composition and biological
 activity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and
 labeling (e.g., signal word, use classification, precautionary labeling, etc.).  Note that the Agency is not
 describing batched products as "substantially similar" since some products within a batch may not be considered
 chemically similar or have identical use patterns.

        Using availableinformation,batching has been accomplishedby the process described in the preceding
 paragraph. Notwithstanding the batching process, the Agency reserves the right to require, at any time, acute
 toxicity data for an individual product should the need arise.

        Registrants of products within a batch may choose to cooperatively generate, submit or cite a single
 battery of six acute toxicological studies to represent all the products within that batch. It is the registrants'
 option to participate in the process with all other registrants, only some of the other registrants, or only their
 own products within a batch, or to generate all the required acute toxicological studies for each of their own
 products. If a registrant chooses to generate the data for a batch, he/she must use one of the products within
 the batch as the test  material.  If a registrant chooses to rely upon previously submitted acute toxicity data,
 he/she may do so provided that the data base is complete and valid by today's standards (see acceptance criteria
 attached), the formulationtested is considered by EPA to be similar for acute toxicity, and the formulation has
 not been significantly altered since submissionand acceptance of the acute toxicity data. Regardless of whether
 new data is generated or existing data is referenced, registrants must clearly identify the test material by EPA
 Registration Number.  If more than one confidential statement of formula  (CSF) exists  for a product, the
 registrant must indicate the  formulation actually tested by identifying the corresponding CSF.

       In deciding how to meet the product specific data requirements, registrants must follow the directions
 given m the Data Call-in Notice and its attachments appended to the RED. The DCI Notice contains two
 response forms which are to be completed and submitted to the Agency within 90 days of receipt.  The first
 form, "Data Call-In Response," asks whether the registrant will meet the data requirements for each product.
 The second form, "Requirements Status and Registrant's Response," lists the product specific data required
 for each product, including  the standard six acute toxicity tests. A registrant who wishes to participate in a
 batch must decide whether he/she will provide the data or depend on someone else to do so. If a registrant
 supplies the data to support a batch of products, he/she must select one of the following options: Developing
 Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing
 an Existing Study (Option 6).  If a registrant depends on another's data, he/she must choose among:  Cost
 Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant
 does not want to participate in  a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should
know that choosing not to participate in a batch, does not preclude other registrants in the batch from citing
his/her studies and offering to cost share (Option 3) those studies.

      All of theseproductscontainthe active ingredientcaptan(cis-N-trichloromethylthio-4-cyclohexene-1,2-
dicarboximide). Several labels report containing related derivatives as well. Some batches also contain other

                                              215

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                                                                                        I	'•	
           active ingredients. Batches 1 through 7B have only captan as an active ingredient and are listed first.  Batch
         ....... , ...... 2 pay cite Batch 1 . Batch 7B may cite the products in Batcfi 7A. The following batches, 8 through 1 6, have
         .......      '1          " .....           ............       .....      1       ...... -                    ...... ' ..... "" .....        " [[[
                      one
         	!:
                           "I'
                          gredent  xose
                                                                           jjatcne(i    ...... |n ..... th"e" ..... gg ftabe"
             	i"
      l	:	A dermal sensi^zadonstud^ is not required. Captan is known to cause dermal sensiti^tionin humans,
       "  s? all products will automatically Ee KaHeleS as such, {unless an acceptable 9ermal sensitizationtest on
                                                                               of captan, waivers will be accepted for
          [the product is negative.

•in^H1^^ e,Y,e. .in^tionunderthe condition that the guideline will be classified as category I. In addition, batches   |
                  Ei22BSIi"iitiŁisE55'5 need'to	'a'ggjfess th'e eye:
  
-------
BATCH
NO.

EPA REG. NO.
34704-430
34704-431
51036-168
66330-1
66330-3
66330-13
66330-25
66330-28
66330-29
66330-30
% of Active Ingredients
80
80
80.1
75
80.1
75
75
80.1
79.6
75
Formulation Type
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
BATCH
  NO.
EPA REG. NO.
                 16-151
                239-729
                270-289
                769-540
                2935-470
               19713-235
               19713-261
               19713-268
               34704-676
                42056-3
               51036-166
                66222-1
               66330-21
% of Active Ingredients
                                          50
                            50
                            50
                            50
                                         50
                            50
                            50
                            50
                            50
                            50
                           48.9
                            50
                            50
                                                 Formulation Type
                                                                   Solid
                                                                   Solid
                                                                   Solid
                                                                   Solid
                                                      Solid
                                                                   Solid
                                                                   Solid
                                                                   Solid
                                                                   Solid
                                                                   Solid
                                                                   Solid
                                                                   Solid
                                                                   Solid
                                              217

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                                                                                                                                                                       Ii

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            ill  iiiiii ill1'
                                                                                                                                                       BIS^^^^^^                                         	,,  1!^    	I,!,1!!!!!!1!!	ISItt^^^
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66330-26
66330-27
48.9
50
Solid
Solid



i
	 ~i 	 | 	 fi 	 ;i 	 =
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BATCH
NO.
4**
EPA REG. NO.
2935-484
7501-26
19713-156
19713-161
51036-167
51035-171
51036-181
66330-23
7501-27
66330-24
% of Active Ingredients
38.52
38.25
38.5
38.5
39.6
39.6
38.2
39.6
38.25
37.66
Formulation Type
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
Liquid
                                                                                                                                                                                                                	|	|	|llll|ll||l|||l| 	II	II  ;

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	I	|	II	ill

	I	:	I:	:"
                                                                                                                                                                                                                                 	Ill	1	Ill	(Ill	II	Ill	I	'lllllll1	
BATCH
NO.
5
EPA REG. NO.
7501-8
34704-649
34704-659
% of Active Ingredients
29.35
30
30
Formulation Type
Liquid
Liquid
Liquid
i <
i
	 1
1
BATCH
NO.
6
EPA REG. NO.
400-225
7501-116
% of Active Ingredients
24.4
25.5
Formulation Type
Solid
Solid
"tfii"
                                                                                                                          218
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                                                                                                                                                                                                                                             	Illlllll

-------
 9779-98
19713-197
34704-567
66330-12
66330-20
25.0
 25
 25
25.1
 25
                                                     Solid
                                                     Solid
                                                     Solid
                                                     Solid
                                                     Solid
BATCH
NO.
7A**


EPA REG. NO.
829-215
5481-250
10107-97
34704-22
34704-149
34704-654
62575-6
66330-10
66330-1 1
66330-15
66330-16
66330-18
% of Active Ingredients
7.5
7.5
7.5
7.5
7.5
7.5
10.1
9\9
7.4
10
7.5
10
Formulation Type
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
Solid
BATCH
NO.
7B**'
EPA REG. NO.
34704-668
66330-14
66330-17
% of Active Ingredients
5.0
5.0
5.0
Formulation Type
Solid
Solid
Solid
                               219

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    IIIIIIH^^^
                                 S^BJSS^^^^'iS^^HSi^^^^^^yf^^'^E'^^^^^^S^I^	xlie'SrstEatclies

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                                                    g_J_,g^_g._.,g__g_-. -—-^^^^^^-^^—^^-^-~.-.^.^-	_^^g_g.



                                                                                                              document if not.
                    I	
BATCH
NO.
8
EPA REG. NO.
4-355
572-62
829-236
% of Active Ingredients
Captan - 6.03
Malathion - 6.00
Methoxychlor - 10.00
Sulfur - 25.00
Captan - 6.0
Malathion - 6.00
Methoxychlor - 1 0.00
Sulfur - 25.00
Captan - 6.0
Malathion - 6.0
Methoxychlor - 9.0
Sulfur -25.0
Formulation Type
Solid
Solid
Solid
                     ii MI                p    ii n   ii      in         ii      in      i  i    I                  	i    ii||||||i i» HI   n   11  n                             ni i   i iiiiii  i        I
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                     iiiiiin inn i luiiiiiiini iiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiii|iiiiiiiin iiiiiiiini inn iiiiiiiiiiiiiiiliiiiiiiiiiiiiiiini inn iiiiiiiiiiiiiiiiii||giii in gn iiiiiiiiini i iiiiiiiiiiiiiiiiiiiiini iiiinn iiiiiiiiiiiiiini n n ininiii i nun iiiiiiiiiiiiiiiini n in iiiiiiiiiiiiiiiiiiiiini  i in mini ininiii iiiiiiiiiiiiiiiiiini iiiiiiiini in iiiiiiiiiiiiiiiiiini 11 n inn i n 11 nun i n i iiniiini iiiiiiiiini iiiinn nn i  iilliiiiiiiiiiiiiiiliiiiiii iniiiii n iiiiiiiiiiiiiini 11 iiiinn in ininiii n nn iiiiiiiiiiiiiiiiiiiiippipiiiiiiii inn in ininiii i iiiiiiiiiiiiiiiiiiiiiini ininiii n n i ininiii 111 u        i        i i     i ' '   '   I n  n        I

                        H Below  are batches that include products  with  captan and other active  ingredients not previously
                                             tmm	IB^^^^	iiiB^^^^^^^^^^^^^^^^^^^^^^^	iira^^^^^^^     	iiiiL!	
iilH^^^^^^^^^^^	|i	I	"Ill	Ill I "in	
BATCH
NO.
9
EPA REG. NO.
68119-14
42056-14
% Active Ingredients
Captan - 32.76
Lindane - 16.60
Captan - 33.5
Lindane - 16.60
Formulation Type
Solid
Solid
BATCH
NO.
10
EPA REG. NO.
7501-38
34704-653
66330-19
IW^^^ 	 114 	 	 11^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
% of Active Ingredients
Captan - 12.24
Lindane - 25.00
Captan - 12.5
Lindane - 25.00
Captan - 12.5
Lindane - 25.0
Formulation Type
Solid
Solid
Solid
ii If J^ j ii, 	 liiiJlii " .i ' 'ii 	 ill i 	 iiMjit J'l 	 'lllii1 ' l"! i 	 i 	 ii 	 i 	 i
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                                                                                                                                                                    •Ill	Illlill
                                                                                        220
                                                                                                                                                                            I

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                                    Ii     i  "i               11     I                         I      '                       I     I	

-------
BATCH
NO.
11
EPA REG. NO.
7501-36
66330-22
% of Active Ingredients
Captan - 19.6
Carboxin - 20.0
Captan - 20.0
Carboxin - 20.0
Formulation Type
Solid
Solid
BATCH
NO.
12
EPA REG. NO.
5905-252
34704-652
66330-4
66330-6
66330-7
% of Active .Ingredients
Captan - 70.0
Methoxychlor - 3.0
Captan - 75.4
Methoxychlor - 3.00
Captan - 73.9
Methoxychlor - 5.0
Captan - 75
Methoxychlor - 3
Captan - 72.5
Methoxychlor - 5.0
Formulation Type
Solid
Solid
Solid
Solid
Solid
BATCH
NO.
13
EPA REG. NO.
68119-10
42056-18
% of Active Ingredients
Captan - 37.5
Diazinon - 25.0
Captan - 37.5
Diazinon - 25.00
Formulation Type
Solid
Solid
BATCH
  NO.
EPA REG. NO.
% of Active Ingredients
                                                Formulation Type
  14
    4-122
                                     Captan - 12.0
                                    Carbaryl - 0.30
                                   Malathion - 6.00
                                 Methoxvchlor - 12.00
                                                     Liquid
                                              221

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                                                                                                                                                                 I'!	 'II	I
'	I	
                                                                                                                            '    '"  'ilnlt
                                                                                                      1"'!	I	i!	i1'"'	I	I	  i
      Illllllll
|::i! 	 : 	 1: 	 II 	
BATCH
NO.
15
5887-162
Ii 	 1 	 • 	 : 	 : 	 Ill 	 , 	 1 	 j:i!: 	 "fi:: 	
EPA REG. NO.
68119-11
42056-11
Captan - 12.0
Carbaryl - 0.30
Malathion - 6.00
Methoxychlor - 12.00
::: 	 „::: 	 I 	 • 	 i: 	 1 	 i 	 ill 	 : 	 : 	 : 	 :::: 	 II 	
% of Active Ingredients
Captan - 15.0
Diazinon - 15.0
Lindane - 25.0
Captan - 15.0
Diazinon - 15.00
Lindane - 25.00
Liquid
Til: 	 	 	 1 	 ::!-!:!! 	 !: 	 "1 	 51:- 	 :li::::: 	 1: 	 I!::!!:! 	 !:! 	 i 	 ;: 	 :::
Formulation Type
Solid
Solid

	I	
BATCH
NO.
16
EPA REG. NO.
7501-111
7501-153
% of Active Ingredients
Captan- 18.4
Etridiazol Terrazole - 2.5
Maneb- 18.75
PCNB - 10.0
Captan- 18.4
Etridiazol - 2.5
Maneb -18.75
PCNB - 10.0
Formulation Type
Solid
Solid
                            The  following products would not fit in a batch.   Therefore testing must be  performed on these
                independently unless indicated by an asterisk.  See acceptable batching for products with asterisk following
        	table,
      ••^^^        111II IIIIIIIIIIIII I Illlllllllllllll I 111 llllllllllllllM  111
            111       1                  II
                                                                •11 11) ill imp ill ii 11 ill i ii  ii i	ill ill nil 1111 in |ii|i|iiiiiiiiiiiiiiiiiiiiiiiiiiii in i iiiiiiH^^^ iiiiiiiii 11 iiiii(iiiiii|
                                                                                                                                  i iiiiiiiiiiiiiiiiliii iiiiiiiii in i iiiiiiiii iiiiiiiii 1
                                                                                                                                                              Illllll 111 Illlili llillliillH        Illllllll
EPA REG. NO.
4-59
70-179*
70-190
% of Active Ingredients
Captan - 6.0
Carbaryl - 0.5
Malathion - 3.0
Methoxychlor - 6.0
Captan - 10.0
Diazinon - 30.0
Captan - 7.0
Malathion - 5.00
Methoxychlor- 10.00
Formulation Type
Solid
Solid
Solid
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EPA REG. NO.
239-568
400-93
400-136*
572-185*
769-645
769-901
802-235
2935-522
7401-355
7401-438
7501-9
7501-43*
7501-77
7501-129
7501-130
7501-131
% of Active Ingredients
Captan- 15.0
Malathion - 7.5
Methoxychlor - 15.0
Captan - 36.7
Carboxin - 37.5
Captan - 12.3
Carboxin - 12.5
Captan - 7.0
Malathion - 4.0
Methoxychlor - 5.0
. Captan - 20.0
PCNB - 14.00
Thiram - 19.00
Captan - 15.0
Malathion - 7.50
Methoxychlor- 19.75
5.1
Captan - 30.0
Maneb - 30%
Captan 6.4
Malathion - 8.07
Methoxychlor - 9.60
Captan- 10.0
Malathion - 7.50
29.35
Captan - 24.4
Carboxin - 12.5
29.35
Captan - 29.0
Thiabendazole - 0.55
Captan - 29.0
Thiabendazole - 0.55
Captan - 20.25
PCNB - 8.4
Thiabendazole - 1.0
Formulation Type
Solid
Solid
Liquid
Solid
Solid
Solid
Solid
Solid
Liquid
Liquid
Solid
Liquid
Liquid
Liquid
Liquid
Liquid
223

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EPA REG. NO.
7501-139

7501-150


10107-94


10163-194


19713-126*
19713- 145*

19713-260*

19713-362
19713-405*

29664-2

33955-408


'SA'inA ^A

34704-342

34704-427
34704-650

34704-651*

34704-655*


34704-681
34704-760




42056-1
% of Active Ingredients
Captan - 45.0
Carboxin - 10.0
PCNB - 15.0

Captan - 12.78
Baytan - 6.25


Captan - 7.5
Streptomycin sulfate - 0.01

Captan - 30.0
2,6-Dichloro-4-nitroaniline - 30.0


18.86
Captan - 25 0
Diazinon - 25.00
75

80.0
78.3

37.3

Captan - 12.0
Malathion - 6.00
Methoxychlor - 12.00
5n
.U
10.0

50.0
Captan - 30.0
Methoxychlor - 2.00

70.0

30.0


15.0
Captan -10.0
Malathion - 10.00
A/fpthnwrfilnr - 1 0 00


18.86
Formulation Type
Solid

Solid


Solid


Solid "


Liquid

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EPA REG. NO.
66330-2*
66330-5
66330-8
66330-9
66330-16
68119-6
68119-7
68119-12
% of Active Ingredients
65.0
62.9
Captan - 65.0
Methoxychlor - 10.0
62.9
7.5
Captan - 25.0
Thiabendazole - 0.68
Captan - 30.0
Thiabendazole - 0.53
Captan - 15%
Lindane - 25%
Diazinon- 15.52%
Metalaxyl- 1.0%
Formulation Type
Solid
Solid
Solid
Liquid
Solid
Solid
Liquid
Solid
*the following batching schemes are acceptable:
70-179 may cite batch 13
400-136 may cite batch 11
572-185 may cite 34704-760
7501-43 may cite batch 11
19713-126 may cite 42056-1
19713-145 may cite batch 13
19713-260 may cite batch 2
19713-405 may cite batch 2
34704-651 may cite batch 2
34704-655 may cite batch 4A
                                            225

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Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprdOO I/forms/.

Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)

Instructions

    1.  Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on
       your computer then printed.)
    2.  The completed form(s) should be submitted in hardcopy in accord with the existing policy.
    3.  Mail  the forms, along with any additional documents necessary to comply with EPA
       regulations covering your request, to the address below for the Document Processing Desk.
       DO NOT fax or e-mail any form containing 'Confidential Business Information1
       or 'Sensitive Information.1

  If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551
or by e-mail at wilk'ams.nicole@epamail.epagov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide
Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of
Distribution of a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State
Registration of a Pesticide To Meet a Special
Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an
Agreement with other Registrants for
Development of Data
Certification with Respect to Citations of Data
(in PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties
(in PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR Notice
98-1)
http://www.epa.gov/opprd001/forms/8570-l.pdf.

http://www.epa.eov/opprd001/forms/8570-4.rjdf.
http://www.epa.gov/opprd001/forms/8570-5.pdf.

http://www.epa.eov/opprd001/fornis/8570-l 7.pdf.
http://www.epa.gov/opprd001/forms/8570-25.pdf.

http://www.eDa.eov/opprd001/forms/8570-27.pdf.
http://www.epa.eov/opprd001/forms/8570-28.pdf.

http://www.epa.gov/oDDrd001/forms/8570-30.pdf.
http://www.epa.eov/opprdOO 1 /forms/8570-32.pdf.

http://www.eDa.eov/opppmsdl/PR Notices/pr98-5.pdf.

http ://www.epa.gov/opppmsd l/PR_Notices/pr98-5 .pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-l .pdf.

http://www.epa.eov/opppmsdl/PR Notices/pr98-l .pdf.

                                          227

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Pesticide	Registration Kit
                                              www.epa.gov/pesticides/registrationkit/.
       E*=^:^^ Dear Registrant:
        our convenience, we have assembled an online
                                                                                       	iiitli
                                                                                 contains fee
                         is and information needed to register a pesticide product with fee U.S. Environmental
l—^^^^stPjotection^gattQyJs Office of Pesticide Programs (OPP):
                             al Insecticide, Fungicide, and Rodenticide Act (FIFRA) and fee Federal Food, Drug
                                                                                             of 1996.

                E—a.      $3-3 Label Improvement Program-Storage and Disposal Statements
                    b,     8^-1 Clarification of Label Improvement Program
                    c.     86-5 Standard Format for Date!
        1^,1	E^^SJi	|,	I2=i	Lifesl	toProvement Program for Pesticides Applied through Irrigation Systems
                          |Chemigation)
                    1111,13	'',	,,	|2-6	iggg	Ingredients	in	Pesticide	Products	Policy Statement
                    !•Ł	„	90-1	liieAlngredients hi pesgc^e products; Revised Policy Statement
                                              i-notifications^and	Minor ^rmulatioiiAniendments	
                             PDF format and requires the Acrobat reader.)
                                         foundat
                  |.	Peslicide,,	Product	Registration Apjrtcation Forms (These forms are in PDF format and will
                  	rreqHrefeeA^rob"at	
                    r  1>" i" i v 	          -                               . •  •     	     i	
             EPA Form No. 8570-4,
                                                          Somet  Formula
                         I,gPA	Fonn.No.	8570=27?	Forrnulatpr's Exemption Statement
                               Fo^No.	jjSTO^j	Certification^with	Respect to Citations of Date
                            ?A Form No. 8570-i3f
                                                    ^ of these forms are in PDF format and will require fee_
                  =	Ł	'	\	"	^eglsSaBon Division Personnel QQJJ^I j^^
                  	!	"i"!!""!!	 T^ if	—j.* _ ? J	Jl' "T\ — 11	i_T	TTfc	tf_ . TPXT • . •   s~r\T*
         ^^j^^e^cidŁs^S^oI^^Ke^^^Dmara^F^^
                                              [ Structure/Contact List
                          53 RR. l59522 Pesticide Registration Procedures; Pesticide Data Requirements (PDF
                          format)
                            ;	CFRPart	156j LabejingRequirements for Pestiddes and Devices ,,(PDF foin^^

   HHB5BBSHH Baasf.   , 	5Q F.R.. 48833, Disclosure of Reviews of Pesticide Data .(November 27,1985)
          iiiS^

   iil   he
                                      lication for registration, you may wish to consult some additional sources
                                                 Web Site
               Ilr2>	The,,	booklet	"General	Informatipn_on	Allying ,for .Registration .of Pesticides in .fee United,
               	§tetes"^	PS92^2T8lX	i^ailable	gjough	the	|^go"ni|	Tediiu^aTEi^mation^rvice	(NTTS)	
                        '"	" '' "     "" 2ss:
                        tionp 'fecnnical Information Service (j^j-jg^

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         5285 Port Royal Road
         Springfield, VA 22161

       The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in the
process of updating this booklet to reflect the changes in the registration program resulting from the
passage of the FQPA and the reorganizationof the Office of Pesticide Programs. We anticipate that this
publication will become available during the Fall of 1998.
   3.  The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center for
       Environmental and Regulatory Information Systems. This service does charge a fee for
       subscriptions and custom searches. You can contact NPIRS by telephone at (765) 494-6614 or
       through their Web site.
  4.   The NationalPesticideTelecommunications Network (NPTN) can provide information on active
       ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by telephone
       at 1-800-858-7378 or through their Web site: ace.orst.edu/info/nptn.

  The Agency will return a notice of receipt of an application for registration or amended registration,
experimental use permit, or amendment to a petition if the applicant or petitioner encloses with his
submission a stamped, self-addressed postcard. The postcard must contain the following entries to be
completed by OPP:

      Date of receipt
      EPA identifying number
      the Product Manager assignment

  Other identifying information may be included by the applicant to link the acknowledgmentof receipt
to the specific applicationsubmitted. EPA will stamp the date of receipt and provide the EPA identifying
File Symbol or petition number for the new submission. The identifying number should be used
whenever you contact the Agency concerning an application for registration, experimental use permit,
or tolerance petition.

   To  assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names, company
experimental codes, and other names which identify the chemical (including "blind" codes used when
a sample was submitted for testing by commercial or academic facilities). Please provide a CAS number
if one has been assigned.

                       Documents Associated with this RED

       The following documents are part of the AdministrativeRecord for this RED document and may
included in the EPA's Office of Pesticide Programs Public Docket.  Copies of these documents are not
available electronically, but may be obtained by contacting the person listed on the respective Chemical
Status Sheet.

       1. Health and Environmental Effects Science Chapters.

       2. Detailed Label Usage Information System (LUIS) Report.
                                          229

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