&EPA
        United States
        Environmental Protection
        Agency	
           Prevention, Pesticides
           And Toxic Substances
           (7508W)
EPA 738-R-95-036
September 1995
Re registration
Eligibility Decision (RED)
Propamocarb
Hydrochloride

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                   UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                     WASHINGTON, D.C.  20460
                                       APR   3  J996
                                                                           OFFICE OF
                                                                       PREVENTION, PESTICIDES
                                                                       AND TOXIC SUBSTANCES
CERTIFIED MAIL
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 propamocarb
hydrochloride which includes the active ingredient propamocarb hydrochloride. The enclosed
Reregistration Eligibility Decision (RED) 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 are due  90 days from
the date of this letter. The second set of required responses are 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.

       If you have questions on the product specific data  requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Edward Setren at (703) 308-8166.  Address any  questions on required generic data to the
Special Review and Reregistration Division representative Paul Lewis at (703) 308-8018.
                                                      Sincerely yours,
                                                      Lois A. Rossi, Director
                                                       Special Review
                                                       and Reregistration Division
 Enclosures

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              SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
             THE REREGISTRATIQN ELIGIBILITY DECISION (RED)

1.  DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, another DCI letter will be enclosed listing such requirements.  If both generic
and product specific data are required, a combined Generic and Product Specific letter will
be enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.

2.  TIME EXTENSIONS AND DATA WAIVER REQUESTS-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 data waivers must be submitted as part of the
90-day response.  Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date.  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 in item 5.

       b.  Five copies of draft labeling which complies with the RED and current regulations
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  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 #PB92-221811; telephone number 703-487-4650).

       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
 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

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 limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
 of five batches.  If you choose the second option, you must submit or cite the data for the five
 batches along with a certification statement as described in 40 CFR §158.175(e).  A copy of
 the CSF is enclosed; follow the instructions on its back.

       e. Certification With Respect to Data Compensation Requirements. Complete and
 sign EPA form 8570-31 for each product.

 4.  COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
 pertaining to the content of the RED may be  submitted to the address shown in the Federal
 Register Notice which announces the availability of this RED.

 5.  WHERE TO SEND PRODUCT SPECIFIC DCI RESPONSES (90-DAY) AND
 APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)

 By  U.S. Mail:

       Document Processing Desk (RED-SRRD-PRB)
       Office of Pesticide Programs (7504C)
       EPA, 401 M St. S.W.
       Washington, D.C.  20460-0001

 By  express:

    Document Processing Desk (RED-SRRD-PRB)
       Office of Pesticide Programs (7504C)
       Room 266A, Crystal Mall 2
       1921 Jefferson Davis Hwy.
      Arlington, VA 22202

 6. EPA'S REVIEWS-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 14 months after the RED
has  been issued.

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                United States,
                Environmental Protection
                Agency	
                    Prevention, Pesticides
                    And Toxic Substances
                    (7508W)   	
EPA-738-F-95-031
September 1995
                 R.E.D.   FACTS
                Propamocarb
                 Hydrochloride
     Pesticide       AH pesticides, sold or distributed in the.United States must be
Rereqistration   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.  The Agency develops
                 mitigation measures or any regulatory controls needed to effectively manage
                 each pesticide's risks. EPA then reregisters pesticides that 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 3124, propamocarb hydrochloride.
    Use Profile
    Propamocarb hydrochloride is a fungicide used to control Pythium
spp. and Phytophihora spp. on turf, outdoor woody and herbaceous
ornamentals. The fungicide is formulated as a soluble concentrate/liquid.
Propamocarb hydrochloride is applied as a bare-root dip, drench and foliar
application.  Propamocarb hydrochloride cannot be applied through any type
of irrigation system. For terrestrial uses, it cannot be applied directly to
water or to areas where water is present or to intertidal areas below the
mean high water mark. Propamocarb hydrochloride treated clippings
cannot be fed to animals or animals allowed to graze in treated areas.
Finally, propamocarb hydrochloride cannot be used in California or on sod
farms in Arizona.

     Almost all usage of propamocarb hydrochloride in the United States is
concentrated on golf courses with approximately 100,000 to 200,000 pounds
of active ingredient applied per year.

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     Regulatory         Propamocarb hydrochloride was first registered as a pesticide in the
         History   u-s-  in 1984- Currently, one product, Banol (EPA Reg. No. 45639-88), is
                     registered. Three Data Call-in notices (DCIs) have been issued for
                     propamocarb hydrochloride.  The first DCI was issued on September 30,
                     1991, under Phase IV of the reregistration program.  It required submission
                     . of acute avian, invertebrate toxicity, hydrolysis, photodegradation, and
                     neurotoxicity data due to associated use patterns and the fungicide being a
                     carbamate. On March 10, 1995, a second DCI was issued for propamocarb
                     hydrochloride and other pesticide active ingredients registered for
                     applications on residential turf.  Under this DCI, submission of foliar
                     residue dissipation, post-application dermal passive exposure and post-
                     application inhalation dosimetry exposure data were required. The post-
                     application dermal passive exposure and post-application inhalation
                     dosimetry exposure studies may be waived pending completion of the
                     database on agricultural and residential post-application/reentry exposure
                     currently being developed by the Agricultural Reentry Task Force and
                     Outdoor Exposure Task Force, provided the registrant is a member of both
                     Task Forces.  A third DCI was issued on October 11, 1995, requiring avian
                     reproduction, fish life cycle, aquatic plant growth, and seedling
                     germination/seedling emergence studies due to use patterns associated with
                     the fungicide.  In addition, foliar residue dissipation, dermal passive
                     dosimetry exposure, inhalation passive dosimetry exposure, honey bee acute
                     contact, estimation of dermal exposure and estimation of inhalation exposure
                     data were required for uses that were not addressed in the March 10 1995
                     DCI.
Human Health
  Assessment
Toxicity
      In studies using mammalian laboratory animals, propamocarb
hydrochloride generally has been shown to be practically non-toxic to
slightly toxic in terms of acute toxicity.  Propamocarb hydrochloride was
classified as slightly toxic for oral, dermal and eye irritation in terms of
acute toxicity and practically non-toxic in terms of acute inhalation and
dermal irritation. The  fungicide was also observed not to be a dermal
sensitizer. In terms of systemic effects, a NOEL of 150 mg/kg/day was
established.
                          Maternal and developmental toxicity studies were conducted.
                    However, due to the high dose at which fetal toxicity was observed, no
                    definite conclusion can be made regarding developmental toxicity.

                          No evidence of mutagenicity or neurotoxicity was associated with the
                    fungicide.  Propamocarb hydrochloride is classified a Group D carcinogen,
                    not classifiable as to human carcinogenicity.  This classification is used for

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                    materials with inadequate human and animal evidence of carcinqgeniqity due
                    to a lack adequate data, as in the case of propamoearb hydrochloride.

                         The reference dose (RfD)  for propamocarb hydrochloride was
                    calculated to be 0.11 mg/kg/day. The RfD is an estimate of the acceptable
                    daily intake of a pesticide taking into account uncertainty factors of the
                    estimation. This RfD was based on a LOEL of 1000 ppm (33.3 mg/kg/day)
                    of a  2-year feeding study in beagle dogs.

                    Dietary Exposure

                         As uses of propamocarb hydrochloride are currently limited to
                    applications to ornamentals  and  turf, no dietary exposure is expected.
                      - "v       " - _•' .         •    "                                   ,

                    Occupational and Residential Exposure

                          There is potential exposure to occupational handlers during
                    mixing/loading/application  of propamocarb hydrochloride products using
                    groundboom  sprayers, high volume/low-pressure sprayers,  low pressure
                    handwand sprayers, high pressure handwand sprayers, backpack sprayers,
                    hose-end  sprayers, hand-held sprinkler cans, and transplant dip by hand.
                    There is also potential exposure to persons entering treated sites after
                    application is complete.

                     Human  Risk Assessment

                          The Agency is concerned  that the risks from post-application •.. ,. ••
                    exposures to treated turf grown for sod and to ornamentals (greenhouse and
                     nursery) grown for sale may be unacceptable based on the risk endpoints
                     identified above for entry immediately following applications.  However, no
                   ,  estimate can be made .for the high volume/low pressure sprayer (commercial
                     turfgrass sprayer) use and the hand-dip use due to the absence of sufficient
                     exposure data at this time.
Environmental
   Assessment
Environmental  Fate
     Propamocarb hydrochloride is relatively non-persistent, is stable to
photodegradation in water, is photodegradable on soil with a half-life of 35
days, degrades fairly rapidly by microbial-mediated metabolism, is
persistent to anaerobic metabolism, dissipates rapidly under field conditions.
has limited hydrolytic potential and bioconcentration in fish, and has

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                       variable mobility from mobile to relatively immobile. Volatilization is not
                       considered a probable route of dissipation. Abiotic hydrolysis is not a
                       significant dissipation process.  However,  base-catalyzed hydrolysis may
                       occur at extremely slow rates.

                       Ecological Effects

                            Propamocarb hydrochloride was observed to be practically nontoxic in
                       terms of avian acute oral toxicity, avian subacute dietary toxicity,
                       freshwater fish acute toxicity, freshwater invertebrate acute toxicity, and
                       slightly to practically non-toxic in terms of mammalian acute oral toxicity.
                       Estuarine/marine acute toxicity ranged from practically non-toxic for mysid
                       shrimp and sheepshead minnow to  slightly toxic for eastern oyster.  No
                       estimate can be provided in terms of terrestrial plant or chronic avian
                       toxicity due to the absence of sufficient data at this  time.

                       Environmental Risk Assessment

                            The LOCs for acute and chronic toxicity for freshwater fish are not
                       exceeded for any current use nor for freshwater invertebrates.  The use of
                       propamocarb hydrochloride on field-grown ornamentals exceeds the Level
                       of Concern (LOG) for birds, mammals and estuarine and marine  mammals.
                       In addition, the lack of data on chronic freshwater fish and honey-bee.
                       exposure does not allow the Agency to conduct the corresponding risk
                       assessments. However, the registrant has proposed  to amend their label to
                       eliminate the field-grown ornamental use.  Thus,  the Agency believes this
                       action will mitigate the LOG exceedance for birds, mammals and estuarine
                       and marine mammals plus requirements for a chronic freshwater fish and
                       honey-bee exposure studies.
Risk  Mitigation
      As mentioned above, the Agency has required avian reproduction to
evaluate chronic risks to birds.  Additional data are also being required
concerning terrestrial and semi-aquatic and aquatic plant toxicity to perform
the corresponding plant risk assessments.

      To lessen the risks of human exposure posed by propamocarb
hydrochloride, EPA is requiring the following risk mitigation measures:

°  For uses within the scope of the WPS, the Agency is requiring persons
entering treated areas before a 24-hour restricted-entry interval has expired
to wear early-entry personal protective equipment consisting of coveralls
over short-sleeve shirt and short pants, chemical-resistant footwear plus

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                        socks, chemical resistant headgear for overhead exposures, and chemical-
                        resistant gloves.

                        o For occupational uses outside the scope of the WPS, EPA is restricting
                        entry into treated areas until sprays have dried.
  Additional  Data        EPA has required the following additional generic studies for
          Required   propamocarb hydrochloride to confirm its regulatory assessments and
                        conclusions:

                        o confirmatory data for post-application exposures for uses on turfgrass at
                        residential sites and at sod-farm sites and for uses on ornamentals in
                        greenhouses.

                        o exposure data for handler activities associated with high volume/low
                        pressure spray and hand-dipping applications.

                        o chronic avian and aquatic invertebrate data and additional terrestrial plant
                        phytotoxicity data.

                              The Agency also is requiring product-specific data including product
                        chemistry and acute toxicity studies, revised Confidential Statements of
                        Formula (CSFs), and revised labeling for reregistration.

Product Labeling         All propamocarb hydrochloride end-use products must comply with
Changes Required   EPA'S current pesticide product labeling requirements and with the
                        following.

                              To remain in compliance  with FIFRA, manufacturing use-product
                        (MP) labeling must be revised to comply with all current EPA regulations,
                        PR Notices and applicable policies.  The MP  labeling must bear the
                        following statement under Directions For Use:

                              "Only for formulation into a fungicide for the following use(s):
                              ornamental sod farms (turf), ornamental lawns and turf, and cutting
                              beds and seedling areas for ornamental herbaceous plants, ornamental
                              woody shrubs and vines."
                              An MP registrant may, at his/her discretion, add one of the following
                         statements to an MP label under "Directions for Use" to permit the

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 reformulation of the product for a specific use or all additional uses
 supported by a formulator or user group:

      (a)    "This product may be used to formulate products for
            specific use(s) not listed on the MP label if the formulator,
            user group, or grower has complied with U.S.EPA
            submission requirements regarding the support of such
            use(s)."

      (b)    "This product may be used to formulate products for any
            additional use(s) not listed on the MP label if the
            formulator, user group, or grower has complied with U.S.
            EPA submission requirements regarding the support of
            such use(s)."

Personal Protective Equipment  (PPE) Requirements for Pesticide
Handlers

      Sole active ingredient end-use products that contain propamocarb
hydrochloride must be revised to adopt the handler PPE requirements set
forth in this section.  Any conflicting PPE requirements on the current
labeling must be removed.

      Multiple active ingredient end-use products that contain propamocarb
hydrochloride must compare the handler personal protective equipment
requirements set forth in this section to the PPE requirements on the current
labeling and retain the more protective. For guidance on  which PPE is
considered more protective, refer to PR Notice 93-7.

Products Intended for Occupational Use


     Minimum PPE requirements (WPS and nonWPS uses): The
     minimum PPE for all WPS  and nonWPS  uses for which groundboom
     applications can be employed is:

           "For groundboom applications, mixers and  loaders must
          wear long-sleeved shirt and long pants, chemical-resistant
          gloves, and shoes plus socks".
          PPE requirements for all other WPS and nonWPS uses: The
          PPE for all other WPS and nonWPS uses will be based on the
          acute toxicity of the end-use product.  This PPE must be

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     compared to the minimum (baseline) (PPE). The more
     protective PPE must be placed on the product labeling. For
     guidance on which PPE is considered more protective, see PR
     Notice 93-7.

     Placement in labeling: The PPE must be placed on the end-use
     product labeling in the location specified in PR Notice 93-7 and
     the format and language of the PPE requirements must be the
     same as is specified in PR Notice 93-7.
Reentry Requirements

     Reentry Interval (REI for WPS uses): A 24-hour REI is
     required for uses within the scope of the WPS (see PR Notice
     93-7) on all end-use products (see tests in PR Notices 93-7 and
     93-11).  This REI must be inserted into the standardized REI
     statement required by Supplement Three of PR Notice 93-7.

     Early reentry PPE requirements: The PPE label language
     required for early entry into WPS treated sites is:

      "For early entry, wear coveralls over short-sleeve shirt and
     short pants, chemical-resistant gloves, chemical-resistant
     footwear plus socks,  and chemical-resistant headgear for
     overhead exposures."

     WPS Notification Statement (WPS uses): The following
      statement must be added to all end-use product labeling that
     contain directions  for one  or more WPS uses:

      "Notify workers of the application by warning them orally and
      by posting warning signs at entrances to treated areas."
      Placement in labeling: The REI must be inserted into the
      standardized REI statement required by Supplement Three of PR
      Notice 93-7. The PPE required for early entry must be inserted
      into the standardized early entry PPE statement required by
      Supplement Three of PR Notice 93-7. The double notification
      statement must be inserted into the Agricultural Use
      Requirements box in the location required by Supplement Three
      of PR Notice 93-7.                                      .

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      Entry restrictions for NonWPS uses: The Agency is
      establishing the following entry restrictions for all nonWPS
      occupational uses of propamocarb hydrochloride end-use
      products:

      "Do not enter or allow others to enter the treated area until
      sprays have dried."

      Placement in labeling:

      If WPS uses are also on label, then follow the instructions in PR
      Notice 93-7 for establishing a Non-Agricultural Use
      Requirements box and place the appropriate nonWPS entry
      restriction in that box.  If no WPS uses are on label, then add
      the appropriate nonWPS entry restriction to the labels of all end-
      use products, except products primarily intended for homeowner
      use, in a section in the Directions For Use with the heading:

      "Entry Restrictions:"

Engineering controls

      The following engineering control statement is required on
      product labeling:

      "When handlers use closed systems, enclosed cabs, or aircraft in
      a manner that meets the requirements listed in the Worker
      Protection Standard (WPS) for agricultural pesticides (40 CFR
      170.240(d)(4-6), the handler PPE requirements may be reduced
      or modified as specified in the WPS."

Application restrictions
     These additional use restrictions are required for
     propamocarb hydrochloride labels:

     "Do not apply this product in a way that will contact workers,
     other people or pets, either directly or from drift. Keep people
     and pets out of the area during application.  Only protected
     handlers may be in the area during application"

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          "Do not apply more than a total of 12 fl. oz. (equivalent to 0.57
          Ib/ai) of propamocarb hydrochloride per 1000 sq. ft. (25 Ibs
          ai/acre/year) of turfgrass per year."

          "Do not use for field-grown ornamentals."

     User safety requirements

          Add the following user safety requirement to the end-use
          product labeling ONLY if PPE (other than long-sleeve shirt,
          long pants, shoes, and socks)  are required on the label due to the
          acute toxicity of the end-use product:

          "Follow manufacturer's instructions for cleaning/maintaining
          protective clothing and equipment. If there are no such
          instructions for washables, use detergent and hot water.  Keep
          and wash protective clothing and equipment separate from other
          laundry."

     User safety recommendations

          "Users should wash hands before eating, drinking,
          chewing gum, using tobacco, or using the toilet."

          "Users should remove clothing immediately if
          pesticide gets inside.  Then wash thoroughly and put
          on clean clothing."
           Add the following user safety recommendation to the end-use
           product labeling ONLY if PPE (other than long-sleeve shirt,
           long pants, shoes, and socks) are required on the label due to the
           acute toxicity of the end-use product:

          . "Users should remove protective clothing and equipment immediately aft
handling this product. Wash the outside of gloves before removing. As soon
as possible, wash thoroughly and change into clean clothing."

Regulatory Conclusion
     The Agency has determined that all uses of propamocarb
hydrochloride, with the exception of the use on field-grown  ornamental
plants plus the high volume/low pressure and hand dipping application
scenarios, are eligible for reregistration. A decision on the  field-grown

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   For More
Information
 ornamentals use plus the high volume/low pressure and hand dipping
 application scenarios cannot be made at this time because insufficient data
 are available to conduct a risk assessment for chronic effects to the
 environment or to characterize the risk to handlers of propamocarb
 hydrochloride via high volume/low pressure and hand-dip uses.  The
 registrant has proposed voluntarily deleting the use for field-grown
 ornamentals from the product registration and is amending their label to
 reduce the maximum application rate for turf.
      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 propamocarb hydrochloride 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 propamocarb hydrochloride 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 Response and
 Program Resources Branch, Field Operations Division  (7506C), Office of
 Pesticide Programs  (OPP),  US EPA,  Washington, DC 20460, telephone
 703-305-5805.
      Electronic copies of the RED and this fact sheet can be downloaded
 from the Pesticide Special Review and Reregistration Information System at
 703-308-7224.  They also are available on the Internet on EPA's gopher
 server,  GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using
 WWW (World Wide Web) on WWW.EPA.GOV.
      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  45242-0419, telephone
 513-489-8190, fax 513-489-8695.
     Following the comment period, the [name] RED document also will
 be available from the National Technical Information Service (NTIS), 5285
 Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
     For more information about EPA's pesticide reregistration program,
 the propamocarb hydrochloride RED, or reregistration of the individual
 product containing propamocarb hydrochloride, please contact the Special
 Review and Reregistration Division (7508W), 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 Pesticides Telecommunications Network (NPTN).  Call toll-
free  1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.
                                       10

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REREGISTRATION ELIGIBILITY DECISION

    PROPAMOCARB HYDROCHLORIDE

                  LIST C

                CASE 3124
           ENVIRONMENTAL PROTECTION AGENCY
             OFFICE OF PESTICIDE PROGRAMS
         SPECIAL REVIEW AND REREGISTRATION DIVISION

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                         TABLE OF CONTENTS
PROPAMOCARB HYDROCHLORIDE REREGISTRATION ELIGIBILITY DECISION
      TEAM	i

EXECUTIVE SUMMARY	v

I.     INTRODUCTION	       1

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	 4

m.   SCIENCE ASSESSMENT	4
            A.    Physical Chemistry Assessment	4
            B.    Human Health Assessment	5
                        •1.    Toxicology Assessment 	5
                                   a.    Acute Toxicity  	6
                                   b.    Subchronic Toxicity	6
                                   c.    Chronic Toxicity and Carcinogenicity
                                           	7
                                   d.    Carcinogenicity Classification	8
                                   e.    Developmental Toxicity  	8
                                   f.    Mutagenicity  	9
                                   g.    Neurotoxicity  . . .	9
                                   h.    Toxicity Endpoints of Concern  .... 10
                  -------2.    Exposure Assessment 	11
                                   a.    Dietary Exposure	11
                                   b.    Occupational Exposure  	11
                        3.    Risk Assessment	14
                                   a.    Dietary 	14
                                   b.    Occupational and Residential  	14
            C.    Environmental Assessment	• 17
                        1.    Ecological Toxicity Data	17
                                   a.    Toxicity to Terrestrial Animals .... 18
                                   b.    Toxicity to Aquatic Animals	19
                                   c.    Toxicity to Plants  	22

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                         2.     Environmental Fate	23
                                     a.     Environmental Fate Summary  .... 24
                                     b.     Environmental Fate and Transport  . 25
                                     c.     Water Resources	31
                         3.     Exposure and Risk Characterization	31
                                     a.     Ecological    Exposure   and    Risk
                                           Characterization	31

 IV.    RISK MANAGEMENT AND REREGISTRATION DECISION	40
            A.    Determination of Eligibility 	40
                         1.     Uses Eligible or Not Eligible at This Time  	41
            B.    Regulatory Position	41
                         1.     Use Deletion; Application Rate Reduction  	41
                         2.     Generic Data Gaps	42
                         3.     Endangered Species 	42
                         4.     Labeling Rationale	43

 V.          ACTIONS REQUIRED OF REGISTRANTS  	47
            A.           Manufacturing-Use Products	47
                         1-          Additional Generic Data Requirements  ... 47
                         2.     Labeling Requirements for Manufactured Use Products
                                                                            48
            B.           End-Use Products	48
                         1.     Additional Product-Specific Data Requirements  . . 48
                         2-          Labeling Requirements for End-Use Products
                               	48
            C.          Existing Stocks	52

VI.         APPENDICES	53
      APPENDIX  A.          Table of Use Patterns Subject to Reregistration  ...  54
      APPENDIX  B.          Table of the Generic Data Requirements and  Studies
                        Used to Make the Reregistration Decision 	57
      APPENDIX  C.          Citations Considered to be Part of the Data Base
                        Supporting the Reregistration of Propamocarb Hydrochloride
                          	64
      APPENDIX  D.          Product Specific Data Call-in	79
            Attachment        1.    Chemical Status Sheets   	91
            Attachment        2.    Product Specific Data Call-in Response Forms
                                    (Form  A inserts) Plus Instructions 	94
            Attachment        3.    Product Specific   Requirement  Status  and
                                    Registrant's Response Forms  (Form B inserts)
                                    and Instructions	99
            Attachment        4.    EPA  Batching of End-Use Products for Meeting
                                    Data  Requirements for Reregistration  . . . 102

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Attachment

Attachment
5.    List of All Registrants Sent This Data Call-In
      (insert) Notice .	  103
6.    Cost  Share,  Data   Compensation   Forms,
      Confidential Statement of Formula Form  and
      Instructions	  104

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PROPAMOCARB HYDROCHLORIDE REREGISTRATION ELIGIBILITY DECISION
TEAM
Office of Pesticide Programs:

Biological and Economic Analysis Division

Gail Tomimatsu
Steve Jarboe
Jihad  Alsadek
Harry Gaede

Environmental Fate and Effects Division

Harry Craven
William R. Effland
Mary Powell
Linda Kutney

Health Effects Division

Alberto Protzel
Winston Dang
Mary Clock
Olga Odiott

Registration Division

Sidney Jackson
Al Smith

Special Review and Reregistration Division

Paul Lewis
Mark Wilhite
Kathleen Depukat

Office of Enforcement and Compliance:

Beverly Updike
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Economic Analysis Branch
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Science Analysis and Coordination Staff
Science Analysis and Coordination Staff
Toxicology Branch II
Occupational and Residential Exposure Branch
Risk Characterization and Analysis Branch
Rish Characterization and Analysis Branch
Fungicide-Herbicide Branch, Team 21
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch

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            GLOSSARY OF TERMS AND ABBREVIATIONS

ADI            Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE            Acid Equivalent
a.i.            Active Ingredient
ARC           Anticipated Residue Contribution
CAS           Chemical Abstracts Service
CI             Cation
CNS           Central Nervous System
CSF           Confidential Statement of Formula
DFR           Dislodgeable Foliar Residue
ORES   ,       Dietary Risk Evaluation System                    ;
D WEL         Drinking Water Equivalent Level (DWEL)  The DWEL represents a medium specific (i.e. drinking
               water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
               occur.
EEC           Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
               such as a terrestrial ecosystem.
EP            End-Use Product
EPA           U.S. Environmental Protection Agency
FDA           Food and Drug Administration
FIFRA         Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA        Federal Food, Drug, and Cosmetic Act
FOB           Functional Observation Battery
GLC           Gas Liquid Chromatography
GM           Geometric Mean
GRAS         Generally Recognized as Safe as Designated by FDA
HA            Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
               organizations when emergency spills or contamination situations occur.       •   .   •   -
HDT           Highest Dose Tested
LC50           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.
LD50           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.
LDlo           Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL           Lowest Effect Level
LOG           Level of Concern                                .     ..  •
LOD           Limit of Detection                .                    .      .
LOEL         Lowest Observed Effect Level                                      .
MATC         Maximum Acceptable Toxicant Concentration
MCLG         Maximum  Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
               contaminants in drinking water under the Safe Drinking Water Act.
jig/g           Micrograms Per Gram
mg/L          Milligrams Per Liter
MOE          Margin of Exposure
MP            Manufacturing-Use Product
MPI           Maximum Permissible Intake
MRID         Master Record Identification (number).  EPA's system of recording and tracking studies submitted.
N/A           Not Applicable
NOEC         No effect concentration
NPDES        National Pollutant Discharge Elimination System
                                                 111

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            GLOSSARY OF TERMS AND ABBREVIATIONS

NOEL         No Observed Effect Level
NOAEL        No Observed Adverse Effect Level
OP            Organophosphate
OPP           Office of Pesticide Programs
PADI          Provisional Acceptable Daily Intake
PAG           Pesticide Assessment Guideline
PAM          Pesticide Analytical Method
PHED         Pesticide Handler's Exposure Data
PHI           Preharvest Interval
ppb            Parts Per Billion
PPE           Personal Protective Equipment
ppm           Parts Per Million
PRN           Pesticide Registration Notice
Q*!            The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC           Red Blood Cell
RED           Reregistration Eligibility Decision
REI           Restricted Entry Interval
RfD           Reference Dose
RS            Registration Standard
SLN           Special Local Need  (Registrations Under Section 24 (c) of FIFRA)
TC            Toxic Concentration. The concentration  at which a substance produces a toxic effect.
TD            Toxic Dose. The dose at which a substance produces a toxic effect.
TEP           Typical End-Use Product
TGAI          Technical Grade Active Ingredient
TLC           Thin Layer Chromatography
TMRC         Theoretical Maximum Residue Contribution
torr            A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
FAO/WHO     Food and Agriculture Organization/World Health Organization
WP            Wettable Powder
WPS           Worker Protection Standard
                                               IV

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EXECUTIVE SUMMARY

       As required under the Federal Insecticide, Fungicide and Rodenticide Act, as amended in
1988,  the U.S.  Environmental Protection Agency (hereafter  referred to  as the "Agency" or
"EPA")  has completed  its  reregistration eligibility decision  (RED) for  the pesticide active
ingredient propamocarb hydrochloride. This decision includes a comprehensive reassessment of
the required target data base and use patterns of the currently registered products.  The Agency
compared its risk assessment to current science and regulatory policies.  Where appropriate, it has
imposed changes to the  terms for continued registration in order to reduce human health and
environmental risks.

       The Agency has determined that all uses of propamocarb hydrochloride, with the exception
of the field-grown ornamental use plus the high volume/low pressure and hand dipping application
scenarios, are eligible for  reregistration.  A decision on the field-grown ornamentals  use plus the
high volume/low pressure and hand dipping application  scenarios cannot be made at this time
because  insufficient data are available to conduct a risk assessment for chronic effects to the
environment or to  characterize the  risk to handlers of  propamocarb hydrochloride via high
volume/low pressure and hand-dip uses.  The registrant has proposed voluntarily deleting the use
for field-grown ornamentals from the product registration and amending their label to reduce the
maximum application rate for turf.

       Because the Agency has identified lexicological endpoints for short and intermediate term
exposure, it is imposing reentry restrictions of 24 hours for uses within the  scope of the Worker
Protection Standard (WPS) for agricultural pesticides or  until after sprays  have dried for other
uses.  Personal protective equipment (PPE) are being required for mixers and loaders for ground
boom applications and for early reentry to certain sites.  The Agency also is requiring exposure-
related data to  confirm the exposure assessments  and adequacies of the PPE  and  reentry
restrictions, as well as, confirmatory data for the assessment of the ecotoxicity and environmental
fate of propamocarb hydrochloride.

Uses

       Propamocarb hydrochloride is used to control the plant disease "damping-off" and has
fungicidal  activity against  Pythium spp.  and  Phytophthora spp.   Current use sites  include
ornamental lawns and  turf, ornamental sod farms (turf), ornamental herbaceous plants, ornamental
woody shrubs and vines.

Human Health Risk

       From its review  of the toxicology data, the Agency concluded that the technical grade
active propamocarb hydrochloride is slightly toxic to practically non-toxtc when administrated by
inhalation, dermal or oral routes of acute exposure.  In addition, the chemical was determined not
to be a dermal sensitizer.

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       A battery of mutagenicity studies were negative for mutagenic effects.  Propamocarb
hydrochloride is classified a Group  D  carcinogen,  that is not classifiable  as  to human
carcinogenicity.

       The  lexicological  endpoint selected  by  the  Agency for both  the  short-term  and
intermediate-term occupational/residential exposure is  a NOEL of 150 mg/kg/day. This is the
maternal NOEL in rabbits for reduced body weight gain during days  6-18 of gestation and the
developmental NOEL for increased post-implantation loss as demonstrated in a developmental
toxicology study.  It is also the NOEL from a 21-day dermal toxicology study with rabbits in
which there was decreased body weight gain in females.

       Based on the fact that the NOEL for systemic effects was 150 mg/kg/day by both the oral
and the dermal routes and in the absence of dermal absorption measurements, the Agency assumes
100% dermal absorption for its occupational/residential exposure assessments.

       The Agency has determined that the Reference Dose (RfD) for propamocarb hydrochloride
should be 0.11 mg/kg/day based on a 2-year feeding study in dogs.  This decision is based on the
threshold LOEL of 1000 ppm (33.3 mg/kg/day in males and females), the lowest dose  tested in
that study.  Body weight gain depression, decreased food efficiency and gastritis were observed
in males of this dose group. The Agency applied  an uncertainty factor (UF) of 100 to account
for both interspecies extrapolation and  intraspecies variability.  An additional UF of 3 was used
to account for the lack of a NOEL.  The Agency believes that the  NOEL is slightly lower than
the lowest dose tested as explained in the summary of the 2-year chronic feeding study with dogs.

       For short and intermediate term occupational exposures, the Agency calculated margins
of exposure (MOE =  NOEL/exposure) for propamocarb hydrochloride product  handlers
(mixer/loaders/applicators).  These  indicated  acceptable margins of exposure  (MOEs^ 100),
where MOEs could be calculated.  However, the Agency is requiring exposure  data for handler
activities associated with high volume/low pressure  spray and hand-dipping applications since
exposure data are unavailable for these use practices.  For uses within the scope  of the WPS, the
Agency is also requiring persons entering treated areas before a 24-hour restricted-entry interval
has expired to wear early-entry personal protective equipment consisting of coveralls over short-
sleeve shirt and short pants, chemical-resistant footwear plus socks, chemical resistant headgear
for overhead exposures, and chemical-resistant gloves.  For occupational uses outside the scope
of the WPS, EPA is restricting entry into treated areas until sprays have dried.  In addition, the
Agency is requiring  confirmatory  post-application exposure data  for uses  on turfgrass at
residential sites and at sod-farm sites and for uses on ornamentals in  greenhouses.  The requested
information has been required through issuance of a Data-Call In (DCI) prior to publication of
this document.

Environmental Risk Assessment

       Adequate data are  available to assess the acute ecological  hazard of propamocarb
hydrochloride, but the Agency does not have sufficient data to assess chronic avian and aquatic
                                           VI

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 invertebrate hazards or adequately characterize the risk to terrestrial or aquatic plant growth and
 terrestrial plant emergence.  Available data indicate propamocarb hydrochloride is slightly toxic
 to  practically  nontoxic to  birds, small mammals, freshwater and estuarine/marine  fish and
 invertebrates.   Based upon the developmental and reproductive effects demonstrated in rats
 (including fetal death at low doses in developmental lexicological studies), chronic effects in avian
 organisms may be expected.  From limited phytotoxicity data, the fungicide was observed to be
 toxic to plants.  The Agency also has concerns that the use oil field-grown ornamentals would
 exceed the acute Levels of Concern (LOG) for non-endangered and endangered birds, mammals,
 estuarine and marine animals.  However, the registrant has proposed to amend their propamocarb
 hydrochloride product registration to eliminate the field-grown ornamental use from the label,
 thereby mitigating these concerns. Because of these remaining ecotoxicological concerns and data
 gaps,  the Agency has required, through a DCI issued prior to  publication of this document,
 submission of chronic avian and  aquatic invertebrate  data and additional terrestrial  plant
 phytotoxicity data to confirm its conclusions about propamocarb hydrochloride's risks to the
 environment.

 Product Reregistration                                        •        ' -   , :

        Before reregistering the products containing propamocarb hydrochloride, 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 finding them acceptable in accordance with Section 3(c)(5)  of
 FIFRA,  the Agency  will  reregister a product. Those  products  which contain other active
' ingredients will be eligible for reregistration only when the other active ingredients are determined
 to be eligible for reregistration.
                                            Vll

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L
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. The amended Act provides a schedule for the reregistration process to be completed in
nine years. 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 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 ingredient 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.

       This document presents the  Agency's decision regarding the reregistration eligibility of
the registered uses of propamocarb hydrochloride. The document consists of six sections. Section
I is the introduction. Section n describes propamocarb hydrochloride, its uses,  data requirements
and regulatory history. Section HI discusses the human health and environmental assessment based
on  the data available to  the Agency.  Section IV presents the reregistration decision for
propamocarb hydrochloride.  Section V discusses the reregistration  requirements for propamocarb
hydrochloride.  Finally, Section VI is the Appendices which support this Reregistration Eligibility
Decision. Additional details concerning the Agency's review of applicable data are available on
request.

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CASE OVERVIEW

A.    Chemical Overview

      The following  active ingredient is  covered  by this Reregistration  Eligibility
Decision:
       Common Name:
propamocarb hydrochloride
       Chemical Name:
propyl[3-(dimethylamino)propyl]carbamate
monohydrochloride
•      CAS Registry Number:     25606-41-1
       OPP Chemical Code:
119302
       Empirical Formula:
C9H21C1N2O2
       Basic Manufacturer:
AgrEvo
B.     Use Profile

       The following is information on the currently registered uses  of propamocarb
hydrochloride with an overview of use sites and application methods. A detailed table of
these uses is provided in Appendix A.  Please note that recently proposed changes are not
presented here.

       Type of Pesticide: fungicide

       Use Sites:

       terrestrial nonfood crop: ornamental lawns and turf, ornamental sod farms (turf)

       terrestrial + greenhouse non-food crop: ornamental herbaceous plants, ornamental
       woody shrubs and vines,  cutting beds, and seedling areas

       Note: the registrant has applied to eliminate the field-grown ornamental use.  This

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       will result in the terrestrial ornamental herbaceous plants, terrestrial ornamental
       woody shrubs and vines, terrestrial cutting beds, and terrestrial seedling areas uses
       being deleted.

       Target Pests: Pythium spp. and Phytophthora spp..

       Formulation  Types  Registered:  soluble  concentrate/liquid  of  66.5%  of
       propamocarb hydrochloride

       Method, Rate and Timing of Application:

              herbaceous ornamentals - at potted stage, dip bare-rooted plants at 0.01 Ib
              ai/gal.  After potted stage or at containerized stage, drench at 0.0003 Ib
              ai/4-in.  pot  or 0.015  Ib ai/10 sq. ft., respectively.  At seed bed  or
;              transplant stage, apply at 0.01 to 0.02 Ib ai/10 sq, ft.  Apply at weekly
              intervals.

              woody  ornamentals -  drench  at  0.12 Ib  ai/10  gallons water.  Repeat
              applications at  three to four month intervals.

              turf - as a preventive treatment, apply O.QfS.to 0.09.Ib ai/1000 sq. ft. As
              a curative treatment, apply 0.14 to 0.19 Ib ai per 1000 sq. ft.  Applications
              are made immediately after germination or at 7 to 21 day intervals. The
              lower and higher rates are used  for, the shorter and longer application
              intervals, respectively.

       Use Practice Limitations:
                      '        '                             '  - .;    ' 1
              Do not  apply through  any type of irrigation system. For terrestrial uses,
       do not apply directly  to water or to areas where surface water is present or to
       intertidal areas below the mean high water mark. Do not feed treated clippings to
       animals  or graze treated  areas.   Do  not use in California or on sod farms in
       Arizona.                                                        .

 C.    Estimated Usage of Pesticide

       Almost all usage of propamocarb hydrochloride in the United States is concentrated
 on golf courses with  approximately 100,000 to 200,000  Ib/ai  applied per year.  This
 estimate is 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 in using data from various information
 sources.

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       D.    Data Requirements

             The Agency issued three Data Call-Ins  (DCIs)  to registrants for propamocarb
       hydrochloride products. The first DCI was issued on September 30, 1991, under Phase
       IV of the reregistration program.  It required submission of acute avian, invertebrate
       toxicity,  hydrolysis, photodegradation,  and neurotoxicity data due to  associated use
       patterns and the fungicide being a carbamate. On March 10, 1995, a second DCI was
       issued for propamocarb hydrochloride and other pesticide  active ingredients registered for
       applications on residential turf.  Under this DCI, submission of foliar residue dissipation,
       post-application dermal passive exposure and post-application inhalation  dosimetry
       exposure data were required. The post-application  dermal passive exposure and post-
       application inhalation dosimetry exposure studies may be waived pending completion of
       the database on agricultural and residential post-application/reentry exposure currently
       being developed by the Agricultural Reentry Task Force and Outdoor Exposure Task
       Force, provided the registrant is a member of both Task Forces.  A third DCI was issued
       on October 11, 1995, requiring avian reproduction, fish life cycle, aquatic plant growth,
       and seedling germination/seedling emergence studies due to use patterns associated with
       the fungicide.  In addition, foliar residue dissipation, dermal passive dosimetry exposure,
       inhalation passive dosimetry exposure, honey bee acute contact, estimation of dermal
       exposure and estimation of inhalation exposure data were required for uses that were not
       addressed in the March 10, 1995,  DCI.

       E.    Regulatory History

             Pesticide products containing propamocarb hydrochloride were first registered in
       the United States  to  Nor-Am Chemical Company in  1984 for use as  a  fungicide.
       Currently, one product, Banol, (EPA 45639-88) is registered.  The formulation  of the
       product is an aqueous solution at 66.5% A.I. Appendix B includes all data requirements
       identified by the Agency for currently registered uses needed to support reregistration.

HI.    SCIENCE ASSESSMENT

       A.    Physical Chemistry Assessment

             Chemical name:     propyl[3-(dimethylamino)propyl]carbamate
                                 monohydrochloride

             Common name:     propamocarb hydrochloride

             Chemical formula:   C9H21C1N2O2

             Molecular weight:    224.73

             Color:              colorless to yellow

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 Physical state:


 Odor:

 Melting point:

 Density:

.Solubility:,.
 Solubility in
 water:,

 Vapor pressure:

 pH:

 Stability:

 Oxidizing or
 reducing action:

 Storage stability:

 Viscosity:

 Corrosion
 characteristics:
                           pure active ingredient - solid
                           technical grade active ingredient - liquid

                           odorless
                           64.2° C

                          . 1.083 g/mL

                           Solvent
                     Hexane
                     Methanol
                     Dichloromethane
                     Toluene
                     Acetone
                     Ethyl acetate
g/L
<0.01
>656
>256
0.14
560.3
4.34
                           >700g/L

                           8 x 10'5 Pa (Pascals) at 25°C

                           4.70

                           stable at room and elevated temperatures (30 to 150° C)


                           oxidizing agent

                           stable stored below 28° C for >  11 years

                           34.23 mpa at 20° C
                           corrosive to iron, copper and brass

B.     Human Health Assessment

       1.     Toxicology Assessment

              The toxicological data base for propamocarb hydrochlbride adequately
       characterizes the potential toxicological effects from the active ingredient as it
       relates to the current registered  use patterns.  The Agency's assessment of the

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              relevant studies are discussed and summarized below.

                     a.     Acute Toxicity

                            A  variety of acute  toxicity tests  have been performed with
                     propamocarb hydrochloride (as 66.5% - 70.0% aqueous solutions).  The
                     acute toxicity values for propamocarb hydrochloride are summarized in
                     Table 1 below.
Table 1; Acute Toxicity
Test
Oral LD50 - rat
Dermal LD50 - rat
Acute inhalation LC30 - rat
Eye irritation - rabbit *
Dermal irritation - rabbit *
Dermal sensitization -
guinea pig *
MRID number
41278115
41278116
93193044
41278117
41278118
00083808
Results
2900 mg/kg (M); 2000 mg/kg
(F)
> 3000 mg/kg
> 7.9 mg/1
Irritation cleared by 72 hours
No erythema after 24 hours
Non-sensitizer
Category
III
III
IV
III
IV
Not applicable
* This study is a requirement for manufacturing-use and end-use products (40 CFR Section 158). For propamocarb
hydrochloride, data have been generated on the TGAI and are presented here for informational purposes.

                     b.     Subchronic Toxicity

                            A 90-day  feeding study was performed in specific pathogen free
                     albino rats at concentrations of propamocarb hydrochloride of 0, 20, 50,
                     100 or 500/1000  ppm in the diet (approximately 0, 1, 2.5, 5 or 25/50
                     mg/kg/day, using a food factor of 0.05) (MRID 00100723). This study by
                     itself does not satisfy the reregistration requirements for a subchronic study
                     in rodents.  However, the reregistration requirement was satisfied when
                     this study was considered together with a 2-year feeding carcinogenicity
                     study in rats (MRID 00101638), as discussed below.

                            A  90-day  feeding study was performed  in  beagle dogs at
                     propamocarb  hydrochloride  concentrations of 0, 50,  100,  500  or
                     1000/2000 ppm in  the diet (approximately 0, 1.25, 2.5, 12.5 or 25/50
                     mg/kg/day,  using a food factor of 0.025).  This study was  classified as

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invalid (MRID 41278119).  As with the rat study above, this study by itself
does not satisfy the reregistration requirement for a subchronic study in
non-rodents. However, .this requirement was .satisfied when this study was
considered  together with  the  2-year feeding study in  dogs (MRID
43044201), as discussed below.

       A 21-day dermal toxicity study was performed with propamocarb.
hydrochloride in Sprague  Dawley  rats at doses  0, 100,  500  or  1000
mg/kg/day, 6  hours/day, 5 days/week  over a 21-day period (total of 15
doses), The NOEL was equal to or greater than 1000 mg/kg/day for both
sexes.  The LOEL was not defined by this study (MRID 42421201).

       A 21-day dermal toxicity study was performed with propamocarb
hydrochloride in New Zealand white rabbits at doses 0, 150, 525 or 1500
mg/kg/day, 6  hours/day, 5 days/week,over a 21-day period (total of 15
doses).   The  LOEL was  525  mg/kg/day based  on  dose-related skin
irritation and depressed body weight gain in mid-dose females.  The NOEL
was equal or greater than 150 mg/kg/day for both sexes (MRID 00071526).
c.     Chronic Toxicity and Carcinogenicity

       Chronic toxicity and Carcinogenicity studies are not required for
reregistration of propamocarb hydrochloride due to its status as a non-food
use pesticide. However, the Agency is using the available chronic toxicity
and Carcinogenicity studies of propamocarb hydrochloride in rats and dogs,
summarized below, to supplement the respective subchronic toxicity studies
in rodents and non-rodents.

       A 2-year feeding/carcinogenicity study was performed in Sprague-
Dawley caesarean  derived rats  with  propamocarb  hydrochloride at
concentrations of 0, 40, 200 or 1000 ppm (0, 1.4, 7.3 or 36.5 mg/kg/day
in males and 0, 1.8, 9.3, or 45.4 mg/kg/day in females).  No significant
lexicological effect was observed at me highest dose (1000 ppm).  The
study was classified as core supplementary because the dose levels tested
were not high enough for Carcinogenicity testing and data on the stability
of the compound in  the test  diet were  not available  for examination.
Although the study was considered by the Agency to be unsatisfactory to
fulfill data requirements for Carcinogenicity testing in rats, the study was
considered to be suitable for  satisfying  chronic toxicity testing in rats
(MRID 00101638).  This study, considered together with the above rat
subchronic study, satisfies the 90-day rodent feeding study requirement.

       A  2-year feeding  study was performed  in beagle dogs  with

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 propamocarb hydrochloride at concentrations of 0, 1000, 3000 or 10000
 ppm (0, 33.3, 103.7, or 356.3 mg/kg/day in males and 0, 33.3,  106.8, or
 334.3 mg/kg/day in females).  This study defined a LOEL of 1000 ppm
 (33.3  mg/kg/day) based on the finding  of body weight gain depression,
 decreased food efficiency and of focal or  multi-focal chronic erosive
 gastritis and/or acute erosions in males.  No NOEL was defined by this
 study.  However, the absence of such gastric lesions in the dog subchronic
 study (MRID 41278119), indicates that the LOEL of 1000 ppm should be
 considered a threshold effect level and  the NOEL for the above effects
 should be only slightly lower than the threshold level.  This study (MRID
 43044201), considered together with the  above dog subchronic study,
 satisfies the 90-day non-rodent feeding study requirement.

 d.     Carcinogenicity Classification

       The  Agency  has  assigned  propamocarb  hydrochloride  a
 carcinogenicity classification of Group  D, not classifiable as to human
 carcinogenicity.  This classification is  generally used for  agents  with
 inadequate human and animal evidence of carcinogenicity or for which no
 adequate data are available, as in the case of propamocarb hydrochloride.

 e.     Developmental Toxicity

       New  Zealand white  rabbits  were  given  gavage  doses  of
 propamocarb hydrochloride of 0, 15, 45, 150, 300, or 600 mg/kg/day on
 GD 6-18.  The maternal toxicity NOEL was  150 mg/kg/day and the LOEL
 was 300 mg/kg/day, based on decreased body weight gains for GD 6-18.
 The developmental toxicity NOEL was 150 mg/kg/day and the LOEL was
 300 mg/kg/day based on increased post-implantation loss (early resorptions
 and fetal death at 300 mg/kg/day, and early and late resorptions at 600
 mg/kg/day).  (MRID 93193043 reformat of MRID 00072574).

       Wistar rats were given gavage doses of propamocarb hydrochloride
 of 0, 74, 221, 740 or 2210 mg/kg/day on gestation days (GD) 6-19.  The
 maternal  toxicity NOEL was 740 mg/kg/day and the LOEL was  2210
 mg/kg/day, based on mortality,  clinical observations (spastic gait, bloody
 snout, bloody vaginal discharge), and decreased body weight gains on GD
.6-20.  The developmental toxicity NOEL was 221 mg/kg/day and the
 LOEL was 740 mg/kg/day, based on increased GD 20 fetal death and
 increased incidence of minor skeletal anomalies (incomplete ossification of
 some sternebrae and vertebrae).  It is noted that the developmental toxicity
 NOEL is less than the maternal toxicity NOEL. Due to the high dose at

-------
 which fetal toxicity was observed, no definite conclusion can be made
 regarding  developmental toxicity  (MRID 93193042 reformat of MRID
 00101641).      "

 f.     Mutagenicity

       Propamocarb hydrochloride was negative (at concentrations of up
 to  5000 /zg/plate) in a Salmonella and E.  coli assay  for gene mutation.
 However, the Agency has classified the test as not acceptable because in the
 absence of cytotoxicity and/or mutagenic;activity, analytical verification of
 the top dosing solution was not-reported. As submitted, this study (MRID
 41278121)  does  not  satisfy gene  mutation-ames  requirements and
 constitutes a data gap for this data requirement.  The Agency has required
 the registrant to upgrade this study by submitting acceptable verification of
 the top dosing solution by October 31, 1995.
                 "   •   "    '          '                 •              ff
        Propamocarb  hydrochloride  was   negative   in   two  mouse
 micronucleus assays (MRIDs 00101642. and 00101643) at doses 5 and 2.5
 mg/kg,  respectively.   The Agency initially classified each study  as
 unacceptable.  However, the Agency has decided that these two studies,
 considered together, are upgraded to acceptable.

        Propamocarb hydrochloride was negative with (at concentrations of
: up to 1100  /u/ml)  and without (at concentrations  of up to  4700 A^g/ml)
 metabolic activation in an acceptable in vitro mammalian cytogenetics assay
 in cultured human lymphocytes (MRID 41278122). The Agency concluded
 that  mutagenicity  data on propamocarb  hydrochloride are adequate to
 satisfy the requirement for structural chromosome aberrations tests.

        Propamocarb  hydrochloride  was  negative in  a  mitotic  gene
. conversion assay with (at concentrations  of up to 24.6  mg/ml in a
 suspension assay, MRID 41278124) and without (at concentrations of up
 to 10 mg/plate in  a plate assay,  MRID 00101645) metabolic activation
 using Saccharomyces cerevisiae strain D4.  Additionally, propamocarb
 hydrochloride was  negative in'a mitotic recombination assay with and
 without (at concentrations of up to 10 mg/plate in a plate assay, MRID
 00101645) metabolic activation using Saccharomyces cerevisiae strain D5.
 When considered together, these studies satisfy the requirement for other
 genotoxic effects (e.g., mitotic recombination in eucaryotes).

 g.    Neurotoxicity

        An oral acute  neurotoxicity study was performed in Sprague-
  Dawley rats at dose levels of 0, 20, 200 or 2000 mg of propamocarb

-------
 hydrochloride/kg. The overall LOEL (combined neurotoxicity/systemic
 toxicity) was 2000 mg/kg for both sexes, .based on soiled fur coat and
 decreased body weight gain in males and  soiled fur coat and  decreased
 motor  activity   in   females.     The   overall  .NOEL   (combined
 neurotoxicity/systemic toxicity) was 200 mg/kg in both sexes (MRIDs
 43062301 and 43013101).

       A 90-day feeding subchronic neurotoxicity study was performed in
 Sprague-Dawley rats with propamocarb hydrochloride concentrations of 0,
 200, 2000, or 20000 ppm (0, 18.2,  189, or 1858 mg/kg/day in males and
 0, 20, 209, or 2089 mg/kg/day in females). Neurobehavioral evaluation
 did  not reveal any treatment-related  functional  observational battery
 findings or changes in motor activity.  Plasma, red blood cells and brain
 cholinesterase activities were comparable to control values.  There were no
 treatment-related gross or neuropathological findings. The overall LOEL
 (combined neurotoxicity/systemic toxicity) was 1858 mg/kg/day in males
 and 2089 mg/kg/day in females (based on decreased body weights and body
 weight gains).  The  overall NOEL (combined  neurotoxicity/systemic
 toxicity) was  189 mg/kg/day  in males and 209  mg/kg/day in females
 (MRIDs 43013102, 43440902, 43440903, and 43440904).

 h.     Toxicity Endpoints of Concern

       The lexicological endpoint  selected by the Agency  for both the
 short-term and intermediate-term occupational/residential exposure is a
 NOEL of 150 mg/kg/day.  This is the maternal NOEL in New Zealand
 white rabbits for reduced body weight gain during days 6-18 of gestation
 and  the developmental  NOEL for increased post-implantation  loss as
 demonstrated in the developmental toxicology study (MRID 93193043)
 summarized  above.   It is also the NOEL  from the 21-day  dermal
 toxicology study with New  Zealand white rabbits (MRID 00071526) in
 which decreased body weight gain in females was demonstrated.

       Based on  the fact that the  NOEL for systemic effects was  150
 mg/kg/day by both the oral and the dermal routes and in the absence of
 dermal absorption measurements,  the  Agency assumes 100%  dermal
 absorption for the occupational/residential exposure assessment.

       The Agency has determined that the Reference Dose (RfD) for
propamocarb hydrochloride should be 0.11 mg/kg/day based on the 2-year
feeding study in beagle dogs (MRID  43044201), as discussed above.  This
decision is based on the threshold LOEL of 1000 ppm (33.3 mg/kg/day in
males and females), the lowest dose tested in that study.  Body weight gain
depression, decreased food efficiency and gastritis were observed in males
                      10

-------
-,-.   . . of this dose group.  The Agency applied an uncertainty factor (UF) of 100
    .to account for both interspecies extrapolation and intraspecies variability.
      An additional UF of 3 was used to account for,the lack of a NOEL. The
  '    Agency believes that the NOEL is slightly lower than the lowest dose tested
      as explained in the  summary of the 2ryear chronic feeding study with
      beagle dogs.                     ,

      RfD = (33.3 mg/kg/day)/(100UF x 3UF) = 0.11 mg/kg/day

.    	,.,.,	The Food and Agriculture Organization/World Health Organization
,    ;  Joint Committee on Pesticide Residues (JMPR) established an Acceptable
      Daily Intake (ADI)  for this chemical of 0.1  mg/kg body weight/day in
      1986,  Two studies were considered  to  be important  in the JMPR
      assessment: a chronic toxicity study in rats with a NOEL of 200 ppm in the
     , diet (equivalent to 10 mg/kg/day), and a chronic toxicity study in dogs with
      a NOEL of 1000 ppm (equivalent to 25 mg/kg/day, apparently using the
      standard conversion factor and not the actual  food intake values  as in the
      Agency'.s evaluation of the same study).

             As propamocarb hydrochloride is not a food use chemical,  a dietary
      analysis  is  not needed.    However,  if  the  status  of propamocarb
      hydrochloride as a non-food chemical changes, the feto toxic NOEL of 150
      mg/kg/day  should be  used as the toxicological endpoint for  the acute
      dietary assessment.

2.    Exposure Assessment

      a.      Dietary Exposure

              As uses of propamocarb hydrochloride are currently limited to
      applications, to ornamentals and turf only, no dietary exposure to residues
      in food/feed commodities are expected.

      b.     Occupational Exposure
              Use patterns

                    Propamocarb  hydrochloride  is  likely to be applied by
              occupational, pesticide handlers,.'rather than homeowners,  with
              tractor-drawn groundboom sprayers,- backpack sprayers,  high-
             ;volume/low-pressure sprayers, (commercial-lawn),  low-pressure
              hand-wand sprayers, high-pressure hand-wand sprayers, hose-end
              sprayersj hand-held sprinkler cans, and as a hand-dip application to
              transplants. Applications can be made as often as every seven days.
                             11

-------
Handler (Mixer/Loader/Applicators) Exposure

       The Agency believes  there  is  potential  exposure  to
occupational  handlers   during  mixing/loading/application   of
propamocarb hydrochloride products using groundboom sprayers,
high  volume/low-pressure  sprayers,  low  pressure  handwand
sprayers, high pressure handwand  sprayers, backpack sprayers,
water-hose-end sprayers, hand-held sprinkler cans, and transplant
dip by hand.

       The current  product  registration  is   used   solely  by
occupational pesticide handlers.  However, since there are no label
restrictions limiting the product's use in this manner, the Agency
included  homeowner applications  in  its  exposure  and risk
assessments.

       The generic  data  from the Agency's  Pesticide Handler
Exposure Database  (PHED) is used to  determine  the potential
exposure   values  for  the  specified  uses   of  propamocarb
hydrochloride.  PHED  is a  compilation of acceptable exposure
studies conducted by registrants with different pesticide chemicals
and for a  variety of mixing, loading  and application  scenarios.
Thus,  the  Agency can apply this  data  base as a  surrogate, if
necessary.   The data base provides the Agency with low to high
confidence in the estimates using the different application methods
depending  upon  the number  of  replicates  available for each
application method.  However,  for certain uses, the Agency lacks
data in PHED or from other sources to estimate exposures. These
uses are high volume/low pressure sprays, hand-held sprinkler can,
and transplant dips (by hand).

       Exposure scenarios for mixer/loader/applicators using  the
different application methods  are presented in Table 2 below.
                12

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                           The  Agency  calculated  estimates  for dermal  and  inhalation
                    exposures using the following formulae:
Daily Dermal Exposure
= Dermal Unit Exposure {
                                          lb AI
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                   Post-Application Exposure

                          The Agency believes there is potential exposure to persons entering
                   treated sites after application is complete.  Post-application exposure may
                   occur: (1) to agricultural workers entering areas of treated turfgrass being
                   grown for sod or ornamentals grown in commercial or research nurseries
                   and greenhouses; (2) to employees and the public in treated recreational
                   areas  (especially  golf courses,  the  primary  use  of  propamocarb
                   hydrochloride); and (3) to homeowners following applications to turfgrass
                   or ornamentals at residential sites.

                          The Agency does  not have chemical-specific  data available to
                   address post application exposure for persons reentering areas treated with
                   propamocarb hydrochloride.

     3.     Risk Assessment

            a.     Dietary

                   EPA  did  not conduct a  dietary  risk assessment for  propamocarb
            hydrochloride since it is currently registered for non-food uses.

            b.     Occupational and Residential

            Risk to Handlers (M/L/A)

                   To assess  potential risks from the use of propamocarb hydrochloride, the
            Agency compared its estimates of dermal exposure in Table 2 (converted to mg/kg
                                          14

-------
body weight/day for a 60 kg person) to the toxicological endpoint NOEL of 150
mg/kg/day for intermediate term and short term exposure.  These exposure
estimates  and this NOEL are described  above.  The ratio of the NOEL to the
estimated exposure level is called the Margin of Exposure (MOE).  MOE values
of 100 or higher indicate to the Agency that the human health risks are low and are
not generally a concern (when the NOELs are based on animal data).

       MOEs were not calculated for the application scenarios of high volume/low
pressure sprayer, handheld sprinkler can and transplant dip (by hand) due to the
lack of exposure data. Also, EPA did not calculate MOEs for the inhalation
exposure  estimates because these values  were considerably less than the dermal
exposure  estimates for all  exposure scenarios  and there  was no  identified
toxicological inhalation endpoints of concern.

       Table 3  below summarizes the corresponding risk assessment for the
occupational uses of propamocarb hydrochloride.
                              15

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                  Based on the estimate for dermal exposure, the MOE is greater than 100
           for the occupational exposure scenario of mixing/loading the liquid formulation for
           groundboom applications. This use scenario is based on mixers/loaders wearing
           long sleeved shirts, long pants, and chemical resistant gloves.  For all the other
           occupational  and homeowner exposure  scenarios for which  MOEs could be
           calculated, the MOEs are greater than 100 without personal protective equipment
           other than long-sleeve shirt, long pants, and shoes and socks.  As noted before, the
           Agency lacks exposure data for high volume/low pressure sprayer, sprinkler can
           and transplant dip (by hand) applications.  The Agency is particularly concerned
           about the potential risk associated  with  the high volume/low pressure  sprayer
           (commercial turfgrass sprayer) use and the hand-dip use, since these application
           methods  may represent  the greatest potential  for propamocarb hydrochloride
           exposure. Details of these requirements are provided in Sections IV and V below.

           Risk From Post-Application Exposures

                  There are no propamocarb hydrochloride chemical specific data available
           to the Agency  to address  post-application  exposures for occupational and
           residential uses.  However, the Agency believes that the risks from post-application
           exposures to treated turf  (other than sod-farm  turf)  appear  to be marginally
           acceptable.  Since contact with the soil subsurface is unlikely at these sites, post-
           application risks should be adequately mitigated by restricting  entry until the sprays
           have  dried.  Also, the risk to people from post-application exposures to treated
           ornamentals not being grown for research or  commercial use (ornamentals in
           parks, ornamental gardens,  interior plantscapes, etc.) should be adequately
           minimized by restricting entry .until the treated surface has dried, since the degree
           of exposure of the people  to residues remaining  on such ornamentals should be
           relatively infrequent and generally of short duration.                 .

                  The Agency also believes that the risks from post-application exposures to
           treated turf grown for sod  and ornamentals (greenhouse and nursery) grown for
           sale may be unacceptable  for entry immediately following applications.   EPA
           assumes that post-application exposures will not pose an  unreasonable risk to
           persons entering these treated areas, as long as entry is .prohibited until 24 hours
           after application, as required  under the Worker Protection Standard (WPS) and
           personal protective equipment is  worn by workers who enter these treated areas
           before the REI has expired.  Details of these requirements are provided in  Sections
           IV and V below.                                    .
C.   Environmental Assessment

     1.     Ecological Toxicity Data
                                    ,	17.,

-------
             The  Agency has adequate  data to assess  the acute hazard of  propamocarb
      hydrochloride to nontarget terrestrial  and aquatic organisms, but lacks data to assess
      chronic avian and aquatic invertebrate  hazards. Available ecotoxicology studies suggest
      propamocarb hydrochloride  is practically nontoxic to  slightly toxic to  birds,  small
      mammals, freshwater and estuarine/marine fish and invertebrates.  However,  propamocarb
      hydrochloride is toxic to plants based on the limited terrestrial and aquatic  plant studies.

             a.     Toxicity to Terrestrial Animals

                   (1)   . Birds, Acute and Subacute

                          To establish the toxicity of propamocarb hydrochloride to birds, the
                   following tests are required: one avian  single-dose oral study (LD50) on
                   one species, preferably mallard or bobwhite quail; and two subacute dietary
                   studies (LC50).  One study should use one species of waterfowl, preferably
                   the mallard duck, and the other study should use one species of upland
                   game bird, preferably bobwhite quail. Tables 4 and 5 present these study
                   results.

Table 4: Avian Acute Oral Toxicity Findings (LDsn)
Species
Ring-necked pheasant
Northern Bobwhite
% A.I.
70.0
71.7
LD,n mg/kg
2,998
> 2,770
Toxicity Category
Practically nontoxic
Practically nontoxic
Fulfills Guideline Requirement
Partially
Yes
Table 5; Avian Subacute Dietary Toxicity Findings
[Species
Northern Bobwhite
Mallard
% A.I.
72.2
72.2
LC5n ppm
> 5,200
> 5,200
Toxicity Category
Practically nontoxic
Practically nontoxic
Fulfills Guideline Requirement
Partially
Partially
                          These results suggest that propamocarb hydrochloride is practically
                   nontoxic to avian species on an acute oral and subacute dietary basis (based
                   on maximum dosage of 5,200 ppm).  The guideline requirement for the
                   acute oral study (LD50) is fulfilled. However, the guideline requirement
                   for the avian subacute dietary study (LC50) is not fulfilled.  This study is
                   supplemental because  the test material was unstable in avian test feed.
                   Additional dietary toxicity testing with bobwhite and mallard duck may be
                   required, pending  the results of avian  reproduction studies as described
                   below. (MRIDs 93193007, 42567901, 42567902 and 42567903)
                                          18

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

                         Avian reproduction studies are required when birds may be exposed
                  repeatedly or continuously through persistence or multiple applications.
                  Use of propamocarb hydrochloride can result in several applications of the
                  end-use product per growing season.  Based on propamocarb hydrochloride
                  use patterns, avian reproduction studies are being required. These studies
                  are to be conducted at concentration levels reflecting maximum expected
                  residue levels on turf following multiple applications (see terrestrial EEC
                  calculations in the Exposure and Risk Characterization section).
                  (3)
Mammals
                         Wild mammal testing is required on a case-by-case basis, depending
                  on  several factors: • results of the lower-tier studies, such as acute and
                  subacute testing; the intended use pattern; and pertinent environmental fate
                  characteristics. In most cases, however, an acute oral LD50 study is used
                  to determine toxicity to mammals.  Table 6 shows the lowest LD50 value
                  for laboratory rats  (66.5% - 70%  aqueous solution) used  in  studies
                  described above in the Human Health Assessment. (MRID 41278115)
Table 6: Mammalian Acute Oral Toxicity Findings
Species
Rat (male)
Rat (female)
LD5n mg/kg
2,900
2,000
Toxicity Category
m
m
                      :   The  available  mammalian  data  indicate  that  propamocarb
                  hydrochloride is practically nontoxic to small mammals on an acute oral
                  basis;      '	:,-,.•.,,
                   (4)
Insects
                         A honey bee acute contact LD50 study is required if the use pattern
                   results in honey bee exposure.   No  data are available to characterize
                  .propamocarb hydrochloride toxicity to bees. These data are being required
                   because applications to field-grown ornamentals may result in honey bee
                   exposure.  However, if this use is deleted, from the label, this study will not
                 .  be required.

            b.     Toxicity to Aquatic Animals
                                          19

-------
                   (1)    Freshwater Fish
                          To establish the toxicity  of a pesticide to freshwater fish,  the
                   minimum data required are two freshwater fish toxicity studies.  One study
                   should use a coldwater species, preferably the rainbow trout, and the other
                   should use a warmwater species, preferably the bluegill sunfish.  Table 7
                   shows these  test  results  from  studies conducted with  propamocarb
                   hydrochloride.
Table 7; Freshwater Fish Acute Toxicity Findings
1 Species
Rainbow trout
Bluegill sunfish
% A.I.
72
72
LCqn ppm a.i.
>99
>92
Toxicity Category
Practically nontoxic
Practically nontoxic
Fulfills Guideline Requirement
Yes
Yes
                          The results of  the  96-hour acute toxicity  studies indicate  that
                   propamocarb hydrochloride is practically nontoxic to fish.  The maximum
                   dosage for the rainbow trout and bluegill sunfish was 99 ppm and 92 ppm,
                   respectively.  The guideline requirement is fulfilled. (MRIDs 42083103,
                   42083102)

                   (2)     Freshwater Fish — Chronic

                          Fish early life-stage tests are  required if the product is expected to
                   be transported to water from the intended use site, and when the pesticide
                   is intended for use such that its presence in water is likely to be continuous
                   or recurrent regardless of toxicity. Fish early life-stage tests also may be
                   required if the actual or estimated environmental concentration in water
                   resulting from pesticide use is less than 0.01 of any acute EC50 or LQ0
                   value and the pesticide is persistent in water.  Available data suggest  that
                   propamocarb  hydrochloride is stable to hydrolysis. Based on the results of
                   the fish early life-stage study,  the corresponding guideline requirement is
                   satisfied.   Table 8 shows the  results  of  the fish  early life-stage tests
                   conducted with propamocarb  hydrochloride. (MRID 42083105)
Table 8; Fish Early Life-Stage Toxicity Findings


Species
Freshwater:
Fathead minnow
% A.I.


72

NOEC
(ppm) A.I.

6.3

LOEC
(ppm)
A.I.
13.0

MATC
(ppm) A.I.

9.0 ppm

Endpoints
Affected

dry weight

Fulfills Guideline
Requirements

yes

                                          20

-------
                         A fish life-cycle test is required when  an end-use product  is
                  expected to be transported to water from the intended use site, and/or when
                  the EEC is equal to or greater than one-tenth of the NOEL in the fish early
                  life-stage test.  The EECs  for turf (following three or more applications)
                  and ornamentals (based on a single 64 Ib ai/A rate) are greater than one
                  tenth of the NOEL in the fish early life stage (6.3 ppm).   The study is
                  required since the use of propamocarb hydrochloride is allowed for three
                  or more applications to turf and ornamentals grown in fields of 10 acres or
                  more.  Thus, this guideline requirement has not been fulfilled under the
                  current allowable use conditions.                    •    .'  •

                  (3)    Freshwater Invertebrates

                         The minimum testing required to assess the hazard of a pesticide to
                  freshwater invertebrates is  a freshwater aquatic invertebrate acute toxicity
                  test, preferably using first instar Daphnia magna or early instar amphipods,
                  Stoneflies, mayflies, or midges.  Table 9 shows the results  of these tests.
                  These data characterize propamocarb, hydrochloride as practically nontoxic
                  to  aquatic invertebrates, on an acute basis.  This guideline is fulfilled.
                  (MRIDs 42567904, 93193013)
Table 9: Freshwater Invertebrate Acute Toxicity Findings
Species
Daphnia magna
Daphnia magna
% A.I.
72%
70%
EC,0 (ppm)
> 106 ppm
423 ppm
Toxicity Category
Practically nontoxic
Practically nontoxic
Fulfills Guideline Requirement
Yes
Partially
                          Aquatic invertebrate life-cycle tests are required if the product is
                   expected to be transported to water from the intended use site,  and when
                   the pesticide is intended for use such that its presence in water is likely to
                   be continuous or recurrent, regardless of toxicity. These tests also may be
                   required if the  actual or estimated environmental concentration in water
                   resulting from use is less than 0.01 of any acute EC50 or LC50 value and the
                   pesticide is sufficiently persistent to affect aquatic invertebrates in water
                   (for  example,  if the  t1/2 is  > 4  days).   Available data suggest that
                   propamocarb hydrochloride is stable to hydrolysis.

                          One study was  conducted with Daphnia magna; however, several
                   discrepancies were  observed  in the  study which  rendered  the  study
                   unacceptable.  These discrepancies include: 1) not all test concentrations
                   were measured;  2) only  half of  the  test animals were retained  per
                   concentration after day 6  (unhealthy or damaged-ones were discarded); 3)
                                          21

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                   growth of the Fl daphnids was not measured and; 4) temperature was not
                   monitored during the test. Therefore, a new invertebrate life-cycle study
                   is needed.

                   (4)     Estuarine and Marine Animals

                          Acute toxicity testing  with  estuarine and  marine  organisms is
                   required when an end-use product is expected to reach the marine/estuarine
                   environment in significant concentrations.  The terrestrial non-food use of
                   propamocarb hydrochloride on turf may result in exposure to the estuarine
                   environment.  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.
                   Table 10 presents  these test results. (MRIDs 42083104, 41834604 and
                   41834603)
Table 10; Estuarine/Marlne Acute Toxicity
Species
Eastern oyster, Shell Deposition
Mysid shrimp
Sheepshead minnow
% A.I.
72%
72%
72%
LCSO/EC50
(ppm)
39.2
> 104.7
>96.8
Toxicity Category
Slightly toxic
Practically nontoxic
Practically nontoxic
Fulfills Guideline
Requirement
Yes
Partially
Yes
                         There is sufficient information to characterize the acute toxicity of
                  propamocarb hydrochloride to estuarine/marine organisms as slightly toxic
                  to practically nontoxic.  The guideline requirement for acute toxicity to
                  mysid shrimp is not fulfilled because 3-day-old shrimp were used rather
                  than ^24-hour old shrimp. However, the value of repeating the study is
                  low in terms of the information to be gained.  Therefore, the acute LC50
                  study with mysid shrimp does not need to be repeated.

           c.     Toxicity to Plants

                  (1)    Terrestrial

                         Terrestrial plant testing  (seedling emergence) is required  for
                  fungicides with terrestrial non-residential outdoor use patterns and/or those
                  which may have endangered or threatened plant species associated with the
                  application site.  Tier 1 toxicity data on  the typical end  product  (TEP)
                  material (73.8%  a.i.  at  the maximum application rate of 8.19 Ib ai/A)
                  indicate  that propamocarb hydrochloride is  toxic to terrestrial  plants
                  (MRID 41834606 and 41834607).  Seedling emergence was affected in
                                         22

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                  45% of the wheat plants and 31.2% of the cucumber plants tested. Tier 1
                  testing  is used  as a coarse  screen  to  determine whether a pesticide
                  potentially poses sufficient risk to warrant higher level modelling. Tier 2
                  testing may be required when Tier 1 tests result in an effect.  Subsequently,
                  Tier 2 testing will provide an ECSO determination.  The Tier 1 guideline
                  requirements for terrestrial plants are fulfilled; however, because of the
                  toxicity shown in the tests,  Tier II emergence studies with  wheat and
                  cucumbers are required.

                  (2)    Aquatic

                         Aquatic plant testing is required for any fungicide with outdoor non-
                  residential terrestrial uses that may result  in off-site movement  through
                  runoff (solubility  > 10 ppm in water). No Tier 1 aquatic plant data are
                  available.  Table  11 presents results from Tier II toxicity testing  using
                  Scenedesmus quadricauda (green alga) and the TEP as the test material.
                  Scenedesmus quadricauda is not a recommended  species for Tier II testing;
                  therefore, the guideline requirement is not fulfilled.  The results  indicate
                  that at 70% ai, the 93-hour EC50 value is 301 mg ai/L. (MRID 41684302)
Table 11: Nontarget Aquatic Plant Toxicity
Species
Scenedesmus quadricauda
%A.I. '
70
Fr1
"'-'SO ras-hcmrt
301 mg ai/L
     2.
         'A  Tier I aquatic  plant study with  Lemna gibba is also being
       required.  If the Tier. 1 study shows effects, a Tier n study with Lemna
       gibba may be required to determine an EC50.

Environmental Fate
            The Agency has reviewed data from environmental fate studies of the persistence
     and mobility of propamocarb hydrochloride under laboratory and field conditions.  The
     environmental fate data base for propamocarb hydrochloride for Terrestrial Nonfood Crop
     and  Greenhouse Nonfood Crop  use patterns is essentially  complete.   However, the.
     environmental fate studies of hydrolysis, anaerobic aquatic metabolism and terrestrial field
     dissipation are of only supplemental quality due to deficiencies described below.  The
     Agency has required the registrant under a separate letter to provide clarifications for these
     studies to confirm the findings and conclusions expressed in this document.  The following
     environmental fate assessment is not expected to change appreciably with the confirmatory
     data.                                                                     ...
                                         23

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 a.     Environmental Fate Summary

        Persistence and  mobility studies  of propamocarb hydrochloride under
 laboratory and field conditions were reviewed and found to be either acceptable,
 partially acceptable and  supplemental.   The  studies determining  laboratory
 persistence  (degradation  and  metabolism  processes)  indicate  propamocarb
 hydrochloride  is  relatively  non-persistent  [half-life  (t1/2)  «14  days],  with
 degradation  primarily through  biotic processes  such  as  microbial-mediated
 metabolism.  Based on marginally acceptable information, abiotic hydrolysis is not
 a significant dissipation process; however, base-catalyzed hydrolysis may occur at
 extremely slow rates.   From acceptable information  on aqueous photolysis,
 propamocarb hydrochloride was reportedly stable to photodegradation in water.
 In an acceptable soil photolysis study, propamocarb hydrochloride was shown  to
 photodegrade on  soil with a t1/2 of *35  days.   Information provided by four
 acceptable aerobic soil metabolism studies suggests propamocarb hydrochloride
 degrades fairly rapidly by microbial-mediated metabolism, with a modal t1/2 of 14
 days and a range of seven to 30 days. Results of the anaerobic soil metabolism
 study suggest propamocarb hydrochloride is persistent to anaerobic metabolism
 with a  tI/2 of  459  days  under- the  study's experimental  conditions.   In  a
 supplemental anaerobic aquatic metabolism study, propamocarb hydrochloride was
 moderately persistent, with an experimentally determined t1/2 of 55 days for a
 German sand sediment.

       The mobility  of propamocarb hydrochloride varies from mobile  to
 relatively immobile.  Propamocarb hydrochloride mobility appears to be a function
 of the pH and clay content (i.e., cation exchange capacity, or CEC) of the treated
 soil.  According to the registrant, propamocarb hydrochloride is an organic base
 (pK.^9.1) that can be protonated in certain soil environments; therefore, increased
 adsorption may  be observed with increasing clay content or CEC and decreasing
 soil  Ph.  Utilizing  information in the submitted studies,  no relationship  with
 adsorption of propamocarb hydrochloride and soil organic matter  content was
 observed. Information provided by the registrant indicate that the vapor pressure
 of propamocarb hydrochloride is 6.0 x  10'7 mm Hg (8.1 x 16  Pa; estimated
 Henry's Law Constant of 2.6  x 10"13); therefore,  volatilization is not considered
 a probable route of dissipation.  Results of supplemental field dissipation studies
 in California and New York suggest propamocarb hydrochloride dissipates rapidly
 under field conditions with a DT50 (dissipation  time of 50%  of the material)
 ranging from 10-15 days.  The bioaccumulation  in fish study indicated limited
potential for bioconcentration in sunfish, with BCFs of 1.5X and  3.OX for edible
 and nonedible tissues, respectively.  Rapid, nearly complete depuration (seven to
 10 days) was also observed in  the bioaccumulation in fish study.
                             24

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b.     Environmental Fate and Transport

       (1)    Degradation

       Abiotic Hydrolysis

      :       The submitted study provides marginally acceptable data on the
       abiotic hydrolysis of propamocarb hydrochloride. Hydrolysis studies of
       [propyl-l-14C]propamocarb hydrochloride suggest it is stable to abiotic
       hydrolytic degradation under elevated temperatures (50-90°  C) and pH
       extremes (pHs of 1, 12, 13 and 14). Although hydrolysis may occur under
       extremely alkaline conditions (pH 14), the rate of hydrolysis appears to be
       limited at ambient temperatures.  Additional information using an OECD
       screening procedure to assess the potential for abiotic hydrolysis supports
       the researchers' assertion that propamocarb hydrochloride is resistant to
       abiotic hydrolysis in the pH 5-9 range at 25° G.

             The experimentally determined half-lives at pH 14 were 6,784 min
       (4.71 days) at 25° C,  124 min at 70°  C, and 34 min at 90° C.  For the pH
       13 test conditions, experimentally derived half-lives were 2,766 min (1.92
       days) at 70° C and 496 min (8.3 hours)  at 90  C.  The experimentally
       determined  half-life  at pH 12  (90° C)  was  4,127  min (2.87  days).
       Calculated half-lives for pH 5, 7, and 9 conditions at 25° C were  1.26 x
       107, 1.26 x 105, and 1.26 x  103 years, respectively.  [NOTE: Information
       on the accuracy of these theoretically determined half-lives is not available.
       Based on the experimentally determined half-life of 4.71 days for pH 14 at
       25° C, alkaline hydrolysis (i.e., at pH 9)  may occur at a faster rate than
       indicated by the theoretical value.] The extrapolated half-life values were
       calculated using the experimentally derived  activation energy and assuming
       "pure base catalysis" for propamocarb hydrochloride. The experiment
       conducted  under extremely acidic conditions (pH 1)  at 70° C suggests
       propamocarb  hydrochloride is stable in acidic environments. (MRID
       00071297)

       Photodegradation in Water

              Propamocarb  hydrochloride did  not  photodegrade  in   "heat
       sterilized"  aqueous solutions  maintained at «24° C  when  exposed to
       artificial sunlight for a maximum of «22 days.  No evidence of degradation
       by abiotic hydrolysis was reported for the dark controls.  In a supplemental
       OECD,  Guideline  study  on the "Phototransformation of Chemicals in
       Water," propamocarb hydrochloride was presumed to be photolytically
       stable because measurements of the  molar decadic absorption coefficients
       were < 3  1 mol"1 cm"1 at wavelengths £295 nm  in pH 4, 7, and 9 buffer
                              25

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 solutions. (MRID 00071296)

 Photodegradation in Soil

       Propamocarb hydrochloride photodegraded with a half-life of 35.4
 days  on  loamy sand  soil that was  irradiated on a  16-hour  daylight
 photoperiod with a dual-filtered xenon arc light for up to  31 days at 17-23°
 C.  In contrast, propamocarb hydrochloride did not significantly degrade
 during 31  days of incubation in the dark. Only propamocarb hydrochloride
 was identified in the irradiated soil; three minor degradates were detected,
 each  at ^8.7%  of  the applied radioactivity.   Material balances in the
 irradiated and dark control soil ranged from 82.7 to 98.7% and 93.3 to
 97.5% of the applied, respectively. (MRID 41834608)

 Aerobic Soil Metabolism

       Propamocarb hydrochloride degraded with a graphically estimated
 half-life of 14 days in loamy sand soil treated at 200 mg/kg and incubated
 in the dark at 25° C and 75% of maximum water-holding capacity.  Only
 propamocarb hydrochloride was identified in the soil; 14CO2 was the major
 degradate  which totaled >70% of the applied at day 30 and 88.6% of the
 applied at 1 year post-treatment. Three minor degradates that comprised
 up to 1.3% (2.6 ppm), 0.4% (0.8 ppm), and 0.3% (0.6 ppm) of the applied
 were   not identified.   Unextracted  [14C]residues,  plus14[  C]residues
 associated with the fulvic acid and humic acid soil fractions, increased to
 a maximum of 20.2%  of  the  applied at 30  days post-treatment,  then
 decreased  to 11.9% at 12 months.  Material balances ranged from 92.6 to
 100.6% of the applied. (MRID 41278125)

      . Propamocarb hydrochloride degraded with an observed half-life of
 14-30 days in a California loamy sand soil that was incubated in the dark
 at 25° C and 75% of maximum water-holding capacity.  Only propamocarb
 hydrochloride was identified in the soil; 14CO2 was the major degradate and
 totaled 88.5% of the applied at 1  year post-treatment.   Three minor
 degradates that comprised up to 0.9%  (1.8 ppm), 0.8% (1.6 ppm), and
 0,2%   (0.4 ppm)  of the  applied were not  identified.    Unextracted
 [14C]residues, plus [14C]residues  associated with the fulvic acid  and humic
 acid soil fractions,  increased to a maximum 37.5% of the  applied at 14
days post-treatment, then decreased to 11.3% at  12 months.  Material
balances ranged from 88.4 to 99.8% of the applied. (MRID 41278126)

       Propamocarb hydrochloride degraded with a half-life of seven to 13
days in loamy sand soil that was treated at 200 mg/kg and incubated in the
dark at 25° C and 75%  of maximum water-holding  capacity.   Only
                      26

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propamocarb hydrochloride was identified in the soil; I4C02 was the major
degradate and totaled  80.0%  of the  applied at 46 days.   Six  minor
degradates that comprised up to 1.40% (2.8 ppm), 1.10% (2.2  ppm),
0.86% (1.72 ppm), 0.78%  (1.56 ppm), 0.37% (0.74 ppm), and 0.20%
(0.4 ppm) of the applied were not identified. Unextracted  [14C]residues
increased to a maximum 23.4%  of the  applied at 13 days post-treatment,
then decreased to 14.55% at 46 days.  Material balances ranged from 93.2
to 102.7% of the applied. (MRID 41278127)    ,

       Propamocarb hydrochloride degraded with a graphically estimated
half-life of 12-13 days in loamy sand soil treated twice at 200 mg/kg (total
application of 400 mg/kg) and incubated in the dark at 25° G and 75% of
maximum water-holding capacity.  Only  Propamocarb was identified in the
soil; 14CO2 was the major degradate, which totaled «55%  of the applied at
day 31 and 66% of the applied at 87 days post-treatment.  Material
balances declined from 89.3% of the applied at three days post-treatment
to 76.2% at 56 days. (MRID 41278128)

Anaerobic Soil Metabolism

       Propamocarb hydrochloride degraded with a half-life of 459 days
in anaerobic (flooded with water plus nitrogen atmosphere) loamy sand soil
that was incubated in the dark at 25° C. The major degradation products
were unextracted residues and evolved 14CO2; three unidentified  degradates
were isolated, each  at £2.0% of the applied.  Unextracted  [l4C]residues
plus NaOH-extracted  [14C]residues ranged from  4.3%  to  8.1%  of the
applied during the study.  Material balances decreased from 96.5% of the
applied at seven days post-treatment  to  84.3%  at 180 days. (MRID
41278129)                           ;

Anaerobic Aquatic Metabolism

       [Propyl-l-14C]propamocarb  hydrochloride (radiochemical  purity
>95%),  at 200 ppm, degraded with a  half-life of 54.8 days in anaerobic
(flooding plus nitrogen atmosphere) sand sediment that was incubated in the
dark at 25° C for 180 days. Propamocarb hydrochloride comprised 87.3%
of the applied radioactivity (sediment plus flood water) at three days post-
treatment (first sampling interval), 66.5%  at 32  days, 44.8% at 60 days,
22.6%  at 102 days, and 2.6%  at 180 days.  Four  unknowns, I, II, III, and
IV, were  isolated.   Unknowns I and II were detected at maximums  of
0.80%  (1.60 ppm) and 0.72% (1.44 ppm) of the applied, respectively. At
180 days post-treatment, unknowns II, HI,  and IV  were a combined
11.22% of the applied (22.44 ppm).
                      27

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       Evolved 14CO2 was the major degradate, totaling 33.1% of the
applied radioactivity at 180 days post-treatment.  Unextracted [14C]residues
plus NaOH-extracted [14C]residues increased to a maximum 3.46% of the
applied at 102 days post-treatment, then decreased to 2.36% at 180 days.
Material balances were 91.8-95.1% of the applied at three to 14 days post-
treatment, decreased to 83.2% by 60 days, and were 51.0% at 180 days.
(MRID 00071465)

       The  study  was determined to be unacceptable for the following
reasons:  1)  the material  balances were incomplete; up to 49.0% of the
applied radioactivity was  unaccounted; 2) no information was provided to
ascertain if the experiment was conducted under anaerobic conditions (e.g.
Eh-pH measurements, Eh is the oxidation reduction potential measured in
millivolts);  and 3)  the limited information  provided  suggests  the
experimental  conditions  were aerobic at the  onset  of the study.   The
guideline requirement is not fulfilled.

Photodegradation in Air

      No  studies  were  reviewed.   The reported  vapor pressure  of
propamocarb hydrochloride is 6.0 x 10"7  mm Hg (8.1  x 10"5 Pa; estimated
Henry's  Law Constant of 2.6 x 10"13).  Therefore,  volatilization and
subsequent photolysis in the atmosphere are not considered probable routes
of dissipation.

(2)   Mobility

Mobility (Batch Equilibrium)

      Propamocarb hydrochloride is  mobile to relatively immobile in
sand, loamy sand,  and sandy loam soils with Freundlich Kads values of
0.67-5.20.  Freundlich Kads values were 0.67 for the sand soil (German
standard soil 2.1), 0.85 for the loamy sand soil (German standard soil 2.2),
and 5.20 for the sandy loam soil (Schering soil 170); respective Koc values
were 140, 41, and 359.  The K^ values were 0.084-1.73 for the sand soil,
0.216-1.35 for the loamy sand  soil, and 0.447-7.96 for the sandy loam soil.
Material balances ranged from  91.5 to 100.3% of the applied radioactivity.
According to the study authors, propamocarb hydrochloride is protonated
in soil environments to form a positively charged (i.e., cationic) species.
Therefore, adsorption increased with increasing soil clay content and CEC,
and decreasing  pH.  No relationship  with adsorption of propamocarb
hydrochloride and  soil organic matter was observed. (MRID 41278130)

Mobility  (Soil Column Leaching)
                       28

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       Based on column leaching studies, [14C]propamocarb hydrochloride
was very mobile (51.9-60.5% of applied radioactivity in leachates) in 30-
cm columns of German "Speyer"  sand soil (soil 2.1) treated with 21 mg
(107 kg ai/ha) of [propyl-l-14C]propamocarb hydrochloride and leached
with 60  cm of water.   [14C] Propamocarb hydrochloride  was relatively
immobile (<0.07% in leachates and 85.8-88.0% throughout the upper 20
cm of columns) in German  loamy sand soil, (soil 2.2) and (
-------
aged (30 days) residues of [14C]propamocarb hydrochloride appeared to be
relatively immobile (0.39-1.96% of the recovered radioactivity in leachates
and 8.1-10.9% in upper 4-5 cm of columns). Material balances were 10.4-
15.1% of the applied radioactivity following leaching.

       This study is supplemental because the experimental methodology
was not sufficiently described; it was not specified if the aged samples were
analyzed for propamocarb hydrochloride and degradates; and it  was not
clear if the material balances were calculated based  on the radioactivity
applied to the soil prior to aging, or based on the radioactivity remaining
on the aged material that was applied to the columns.

Volatility - Laboratory and Field

       No  studies  were  reviewed.    The reported  vapor  pressure of
propamocarb hydrochloride is 6.0 x 10"7 mm Hg (8.1 x 10"5 Pa (Pascals);
estimated Henry's Law Constant of 2.6 x 10"13); therefore, volatilization is
not considered a probable route of dissipation.

(3)     Bioaccumulation in Fish

       Propamocarb  hydrochloride   residues  did   not   significantly
accumulate in bluegill sunfish exposed to propamocarb hydrochloride at 1.0
ppm for 28 days. Maximum bioconcentration factors  were  1.5X in edible
tissues and 3.OX in nonedible tissues. During the exposure period, mean
total  [14C]residues  in the treated water ranged from 1.06 to 1.14 ppm.
Depuration was rapid; propamocarb  hydrochloride residues were not
detected in the fish tissues by days seven to 10 of the depuration period.
(MRID 41278114)

(4)     Field Dissipation

       Propamocarb hydrochloride dissipated with half-lives of 10.2 and
15.2 days in the upper 8 cm of turf plots (80 x 80 feet) of sandy loam soil
in New York and  California,  respectively,  following four applications
(seven-day intervals) of propamocarb hydrochloride  (Banol SC/L; 722 g
ai/L) at 8.97 kg ai/ha/application (36 kg ai/ha  total) in early August 1990.
Limited detections of propamocarb hydrochloride were observed to  >91
cm  at  the New York site  and up  to  46  cm at  the California  site.
Propamocarb hydrochloride was detected in several subsurface soil  samples
at various concentrations during different sampling times, which  suggests
sample contamination from improper sampling techniques.  However, no
soil sampling information was given to help evaluate this potential problem.
                       30

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       c.
       This study is supplemental because the soil at the New York site
was  not sampled deep enough to define the potential for propamocarb
hydrochloride to leach under field  conditions;  thus, the  corresponding
guideline requirement is not satisfied. Therefore,  the problems with the
portion of this study conducted in New York cannot be resolved with the
submission of additional data. To be able to use the portion of this study
conducted  at the California site toward fulfilling  the terrestrial  field
dissipation data requirement, the registrant must submit acceptable freezer
storage stability data demonstrating  that propamocarb hydrochloride is
stable  in soil during the maximum  storage interval that  the field  soil
samples were stored from sampling to analysis.  Also, the registrant should
describe the soil sampling procedures and provide the missing field test
data.  This information has been  requested'of the registrant.  (MRID
42421202)

(5)     Spray Drift

       These  studies  may  be  required  when  human  or ecological
lexicological considerations are indicated.  The registrant is,a participating
member of the  Spray Drift Task Force- (SDTF)."  Information regarding
spray  drift of propamocarb hydrochloride should be provided upon
completion  of  the  SDTF data  base.   Information  on spray drift of
propamocarb hydrochloride  from ground application may be estimated
from the forthcoming results of the SDTF studies.

Water Resources
             Based on the environmental fate assessment for propamocarb hydrochloride
       with consideration of the product formulation and application rates, the Agency
       believes use of propamocarb hydrochloride will not pose serious concerns for
       either groundwater or surface water media.      •

3.     Exposure and Risk Characterization

       a.     Ecological Exposure and Risk Characterization

       Explanation of the Risk Quotient (RQ) and the Level of Concern (LOC): The
       Agency uses the Levels of Concern (LOG) as criteria to indicate potential risk to
       nontarget organisms.  The criteria indicate that 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
       faunal groups and one category (acute) for each of two nontarget floral groups.
       To, determine  if an LOC  has been exceeded, a risk quotient is derived and
       compared to the LOCs. A risk quotient is calculated by dividing an appropriate
                                    31

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            exposure estimate by an appropriate toxicity test effect level, such as the LC50 for
            acute effects or NOEL for subchronic or chronic effects .

            Typical acute effect levels are:
                 for terrestrial plants,
            EC50 for aquatic plants and invertebrates,
            LC50 for fish and birds, and
            LD50 for birds and mammals.

            Chronic test results are:

                  for avian and mammalian reproduction studies, the no observed effect level
                  (NOEL) or concentration (NOEC); and

                  for chronic aquatic studies, either the NOEC or the maximum allowable
                  toxicant concentration (MATC).  The MATC is the geometric mean of the
                  NOEC and the lowest observable effect concentration (LOEC).

            When .the risk quotient exceeds the LOG, the Agency presumes there is potential
            risk to that category.  The Agency's risk presumptions  and the corresponding
            LOCs are shown in Tables 12, 13 and 14.

Table 12; Levels of Concern (LOG) and Associated Risk Presumption; Mammals and Birds
If the
acute RQ>
acute RQ>
acute RQ>
chronic RQ>
LOC
0.5
0.2
0.1
1
Presumption
High acute risk
Risk that may be mitigated through restricted use
Endangered species may be acutely affected
Chronic risk - Endangered species and other non-target
affected
species may be chronically
Table 13; Levels of Concern (LOG) and Associated Risk Presumption; Fish and Aquatic Invertebrates
If the
acute RQ>
acute RQ>
acute RQ>
chronic RQ >
LOC
0.5
0.1
0.05
1
Presumption
High acute risk
Risk that may be mitigated through restricted use
Endangered species may be acutely affected
Chronic risk - Endangered species and other non-target species may be
affected
                                        32

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  Table 14; Levels of Concern (LOG) and Associated Risk Presumption; Plants
If the
RQ>
LOG
1
Presumption ||
High risk - Endangered plants
and other non-target plants
'
may be affected |
                           Currently, no separate criteria exist for restricted use or chronic
                    effects to plants.            •

                    (1)    Exposure and Risk to Nontarget Terrestrial Animals

                           (a)    Birds-Turf

                                  Residues   found   on  dietary  food  items  following
                           propamocarb hydrochloride application may be compared to LC50
                           values to predict hazard.  The table below demonstrates for the turf
          • .-•••          use, the maximum concentration of propamocarb hydrochloride
                           residues that may be expected on selected avian and mammalian
                           dietary food items following both single and multiple  applications.
                           The resulting avian risk quotients are shown in Table 15.

 Table 15: Estimated Environmental Concentrations (EEC) for Avian and Mammalian Dietary Food Items in ppm
and Avian Risk Quotients (RQ) based on the EECs for turf/the highest test concentration in the LC50 studies, 5,200
 pm
, Food items
Short grass
Long grass
Broadleaf/'
Insects
Fruit/Seeds
EEC (ppm)
(1 application of
8.19 Ibs ai/acre)
1,966
901
1,106
123
EEC (ppm)
(3 appls. of 8.19 Ibs ai/acre
or 6 appls. of 4.1 Ibs ai/acre
with no degradation)
5,898
2,703
3,318
369
RQ
(single 8.19 Ib
ai/acre appl.)
; <0.38
<0.17
<0.21
<0.02
RQ
(multiple
applications)
<1.1
<0.5
<6.6
<0.06
                                  Precise LC50 values were not determined in the avian dietary
                            studies summarized in Table 15  because concentrations were not
                            high enough to  cause 50%  mortality.  The highest concentration
                            tested (5,200 ppm)  was used in the risk quotient calculations.
                            Propamocarb hydrochloride may be applied to turf at a maximum
                            rate of 4 fluid  oz per 1000 sq ft.  This is equivalent to 8.2 Ibs
                            ai/acre. The EECs following three applications at 8.19 Ibs ai/acre
                                            33

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or 6 applications at 4.1  Ibs ai/acre to turf (no  degradation) are
calculated to reach a maximum of 5,898 ppm. This residue level
exceeds the highest test concentration in the avian dietary studies.
However, the risk is uncertain because of several factors, including:

       although LC50  values were not determined in the avian
       dietary toxicity studies, they were higher than the values
       used in the risk quotients;

       the  test material was unstable in avian test feed; and

       available residues  on turf in the environment may be lower
       than the maximum calculated EECs because of dissipation
       and mowing.

       No  avian  reproduction  studies  are available.   However,
based upon developmental and reproductive effects demonstrated in
rats   (including  fetal  death  at  low  doses  in  developmental
lexicological studies),  chronic effects  in avian organism may be
expected. Therefore, the effects of propamocarb hydrochloride on
avian reproduction needs to be evaluated  for the turf use which may
involve multiple applications. The avian reproduction  studies will
enable the Agency to evaluate chronic risks to birds to better clarify
the acute risk for birds.

(b)    Birds — Ornamentals

       The use of propamocarb hydrochloride on ornamentals
grown in greenhouses and pots within nurseries does not pose a risk
to birds  since  there is  no  expected  exposure.    However,
propamocarb  hydrochloride  may be applied  to  field-grown
ornamentals at a maximum rate of 0.0147 Ibs ai/10 sq ft.  This is
equivalent to 64 Ibs ai/acre.

       Table   16  shows   the  maximum  concentrations  of
propamocarb hydrochloride residues  that may be expected  on
selected avian or mammalian dietary food items following a single
application of 64  Ib ai/acre to ornamentals and the resulting avian
risk quotients.  The risk quotients exceed high risk LOCs for birds.
However, the registrant has proposed to amend their propamocarb
hydrochloride  label to eliminate the field-grown ornamental use.
Thus,  the  Agency believes this action  will mitigate the LOG
exceedance for birds.
                34

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  Table 16: Estimated Environmental Concentrations (EEC) for Avian or Mammalian Dietary Food Items in ppm
and Risk Quotients (RQ) based on the EECs for ornamentals/the highest test concentration in the LCSO studies,
5,200 ppm
Food items
Short grasses
Long grasses
Broadleaves/insects
Fruits/seeds
EEC (single application) (64 Ibs ai/A)
15,360
7,040
8,640
960
RQ
<3.0
<1.4
<1.7
<0.2
                            (c)    Mammals

                                  Risk to small mammals is assessed using the acute oral LD50
                            value of 2,000 mg/kg, the body weight of the animal in grams and
                            the food  consumption in grams per day.  The estimated LC50 is
                            derived using the following formula, and approximates the dietary
                            toxicity for the animal:

                            LC50 =LD50 x body weight (g)
                                  food consumption per day (g)

                                  Table 17 lists the estimated LC50s.

  Table 17; Small Mammal Food Consumption in ppm based on a laboratory rat LDSO value of 2,000 mg/kg '
Small Mammal
Meadow vole
Oldfield mouse
Least shrew
Body Weight
(grams)
46 -
13
• •• 5
% of Weight
Eaten/Day
61%
16%
110%
Food Consumed/
Day (grams)
28.1
2.1
5.5
Estimated LC50/ Day
(ppm)
3,274
12,381
1,818
                      D. E. Davis and F. Golly. Principles of Mammology. Reinhold Corporation, 1963.

                           The estimated LC50 is then compared  to the residues (EECs)  to
                     calculate the mammalian risk quotient (EEC/LC50).  Table 18 indicates the
                     mammalian risk quotients  for the turf (8.19 Ib a.i./A) and field-grown
                     ornamental uses (64 Ib a.i./A).
                                            35

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  Table 18: Mammalian Dietary Risk Quotients
Small Mammal
Meadow
Oldfield
vole consuming range grasses
mouse consuming seeds
Least shrew consuming forage and insects
Dietary RQ *
8. 19 single
application
(Ibs. a.i./A)
0.6
0.01
0.3
64 single application
(Ibs. a.i./A)
4.7
0.06
2.0
* Dietary RQ = EEC/lowest estimated LC50
                                  Small mammals are potentially at high acute risk for use of
                           propamocarb hydrochloride on both turf and ornamentals.   For
                           mice, the marginally exceeded LOCs calculated assume maximum
                           use and that propamocarb hydrochloride does not break down.  The
                           use of propamocarb  hydrochloride on  ornamentals  grown in
                           greenhouses and pots within nurseries does not pose a high risk to
                           mammals.

                           (d)    Insects

                                  No  data are available to assess the risk of propamocarb
                           hydrochloride to non-target insects.

                    (2)    Exposure and Risk to Nontarget Aquatic Animals

                    Expected Aquatic Concentrations

                           Propamocarb hydrochloride  is slightly toxic to practically nontoxic
                    to the aquatic organisms tested to date.  Table 19 lists the EECs calculated
                    using  the Generic  Expected  Environmental  Concentration  Program
                    (GENEEC).  GENEEC is a program to calculate both acute and chronic
                    generic expected environmental concentration values. It considers reduction
                    in dissolved pesticide concentration due to adsorption of pesticide to soil or
                    sediment, incorporation,  degradation  in soil before washoff to a water
                    body, direct deposition of spray drift into the water body,  and degradation
                    of pesticide within the water body.  For turf and field-grown ornamental
                    uses, the estimates were based on runoff from a  10 hectare field to a one
                    hectare x two meter deep pond.  These generic  EECs take into account
                    degradation in the field prior to a rain event.  The following environmental
                    fate parameters were used in the model:  soil KOC,  50.0; solubility, 50,000
                    ppm; aerobic soil metabolism half-life, 14 days; hydrolysis,  0; photolysis
                                           36

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                  in water, 0; aquatic metabolism, 0.  EECs for the turf use were calculated
                  for one application and three applications seven days apart.
Table 19: Estimated Environmental Concentrations (EECs) using GENEEC
Crop


Turf: one

Turf: three

Ornamentals:

Application
Method

ground

ground

ground

Application
Rate (Ibs
a.i./A)
8.19

8.19

64

Initial
EEC
(ppb)
353

862

2,760

4-day
EEC
(ppb)
352

861

2,750

21-day
EEC
(ppb)
351

857

2,740

56-day
EEC
(ppb)
347

849

2,710

                         (a)    Freshwater Fish

                                As presented above in Table 13 (Levels of Concern [LOG]
                         Associated Risk Presumption: Fish and Aquatic Invertebrates), the
                         Agency's acute and chronic LOG for freshwater fish are met or
                         exceeded if the RQ >^ 0.5 to 1.0, respectively. For propamocarb
                         hydrochloride, the acute and chronic LOCs for freshwater fish are
                         not exceeded  for any  current  use.    For reasons previously
                         discussed, the precise LC50 values for freshwater fish were not
                         determined in the studies; therefore, the highest test concentrations
                         in the acute fish studies were used in the risk quotient calculations.
                         These were 92.0 and 99.0 ppm for bluegill sunfish and rainbow
                         trout, respectively. The chronic MATC is 9.0  ppm.  Table 20
                         provides the acute and chronic risk quotients for freshwater fish.
                                          37

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Table 20; Risk Quotients (RQ) for Freshwater Fish
Crop/application rate
Turf/8. 19 Ibsai/A
(one application)
Turf/8. 19 Ibsai/A
(three applications)
Ornamentals/64 Ibs ai/A
(one application)
Species
Bluegill
Rainbow trout
Fathead minnow
Bluegill
Rainbow trout
Fathead minnow
Bluegill
Rainbow trout
Fathead minnow
Acute RQ (96-hr)
(EEC/highest test
concentration)
< 0.004
< 0.004
<0.01
< 0.005
<0.03
<0.03
Chronic RQ (60-day)
(EEC/MATC)
0.04
0.07
0 31
                         (b)    Freshwater Invertebrates

                               The use of propamocarb hydrochloride does not exceed the
                         acute endangered species LOCs for freshwater invertebrates (RQ >
                         0.05), as shown in Table 21 below.  No chronic toxicity data for
                         freshwater invertebrates are available for use in a risk assessment.
Table 21: Risk Quotients (RQ) for Freshwater Invertebrates (48 hr. ECSO = 106 ppm)
Crop/application rate
Turf/8. 19 Ibs ai/A
(one application)
Turf/8. 19 Ibs ai/A
(three applications)
Ornamentals/64 Ibs ai/A
(one application)
Species
Daphnia magna
Daphnia magna
Daphnia magna
Acute RQ (48-hr)
(EEC/highest test
concentration)
0.003
0.005
0.03
Chronic RQ (21 -day)
(EEC/MATC)
N/A
N/A
N/A
                        (c)     Estuarine and Marine Animals

                               For the turf use, the acute LOCs for estuarine and marine
                        animals are not  exceeded.   However, following propamocarb
                        hydrochloride applications  to  10-acre  plots  of field  grown
                        ornamentals, the high risk LOG (Acute RQ for oyster = 0.70) is
                        exceeded.   The precise LC50 values for sheepshead minnow and
                        mysid shrimp were not determined in the studies.  Therefore, the
                        highest test concentrations in  the studies  were used  in the risk
                                       38

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                          quotient calculations.-   These  were  96.8  and  104.7  ppm for
                          sheepshead minnow and mysid shrimp, respectively.  The EC50
                          value for the eastern oyster is 39.2 ppm.

                                 Table 22 presents the acute risk quotients.   '

Table 22: Risk Quotients (RQ) for Estuarine and Marine Organisms
Crop/application rate
Turf/8. l'91bsai/A
(one application)
Turf/8. 19 Ibsai/A
(three applications)
Ornamentals/64 Ibs ai/A
(one application)
Species
Sheepshead minnow
Oyster j
Mysid
Sheepshead minnow
Oyster
Mysid
Sheepshead minnow
Oyster
Mysid
Acute RQ (96-hr)
<0.004
0.009
< 0.003
<0..005 .
0.015
< 0.005
<0.03
0.70
<0.03
                    (3)    Exposure and Risk to Nontarget Plants

                           (a)     Terrestrial and Semi-Aquatic

                                  Tier  1 toxicity data on  the typical end product (TEP)
                           material (73.8% a.i. at the maximum application rate of 8.19 Ib
                           ai/A) indicate that propamocarb hydrochloride is toxic to terrestrial
                           plants.   Seedling emergence was affected in 45%  of the wheat
                           plants  and 31.2% of the cucumber plants tested.  Based on these
                           results, movement of propamocarb hydrochloride  off-target via
                           runoff or spray drift may be  expected to adversely affect non-target
                           plants.  However, risk quotients cannot be calculated for seedling
                           emergence until Tier II studies are submitted.  Such information
                           will provide EC25 values to perform a plant risk assessment.

                           (b)    Aquatic

                                  Exposure to non-target aquatic plants may occur through
                           runoff and drift. The Agency estimated EECs using the GENEEC
                           program and estimated the toxicity using the 93-hour EC50 301 ppm
                           from the study with Scenedesmus  quadricauda summarized above.
                           Table 23 shows the resulting risk quotients for aquatic plants.
                                           39

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 Table 23; EECs and RQ for Aquatic Plant Species
Use Site
Turf
Turf
Ornamentals
Maximum
Application Rate
8.191bsai/A
(1 application)
8.191bsai/A
(3 application)
64 Ibs ai/A
(1 application)
Type of Plant
Algae
Algae
Algae
Type of EEC
(GENEEC)
runoff and 1 %
spray drift
runoff and 1 %
spray drift
runoff and 1 %
spray drift
EEC
(ppb)
353
862
2,760
Risk Quotient
(EEC/ECJ
0.001
0.003
0.009
                                  An algae risk assessment is a useful indicator to determine
                           impact  to food  sources for  fish, aquatic invertebrates, and
                           waterfowl. Based on these risk quotients, there appears to be low
                           risk to organisms relying on algae as a source of food.  However,
                           an additional Tier I aquatic plant test for Lemna gibba has been
                           required (see section on toxicity to aquatic plants).

                     (4)    Endangered Species

                           Endangered species LOCs  have been  exceeded  for birds and
                     mammals for the use of propamocarb hydrochloride on turf and field
                     ornamentals.   In addition, the LOCs  for endangered marine  animals
                     (mollusks) have been exceeded for field-grown ornamentals. Application
                     to  woody ornamentals  may  also  exceed endangered  species LOCs
                     depending on the application rate used.

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 the active ingredients
  are eligible for reregistration.  The Agency has  previously identified and required the
  submission of the generic (i.e. active ingredient specific) data required to support reregistration
  of products containing  propamocarb hydrochloride active ingredients.  The Agency has
  completed its review of these generic data, and has determined that the data are sufficient to
  support reregistration of all products containing propamocarb hydrochloride, with modifications
  as  specified in this document,  and that the  fungicide  can  be  used  without resulting  in
  unreasonable adverse effects to humans and the environment. Therefore, the Agency concludes
  that products containing propamocarb hydrochloride for all uses, except the field-grown
  ornamental use plus the high volume/low pressure and hand dipping application scenarios, are
  eligible for reregistration.  A reregistration decision  cannot  be made on the field-grown
  ornamental use plus  the high volume/low pressure and hand dipping  application scenarios due
                                           40

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to data deficiencies.  Appendix B identifies  the generic data requirements that .the Agency
reviewed as part of its determination of reregistration eligibility of propamocarb hydrochloride,
and lists the submitted studies that the Agency found acceptable.

     The Agency made its reregistration eligibility determination based upon the target data
base required for reregistration,  the current  guidelines for conducting acceptable studies to
generate such data,  published scientific literature, etc. and the data identified in Appendix B.
Although the Agency has found  that all uses of propamocarb hydrochloride are eligible for
reregistration, with  modifications as specified in this document, and with the exception of the
field-grown ornamental use, 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 propamocarb hydrochloride, if new information comes to the Agency's
attention, including the  additional,  required confirmatory  generic  data  mentioned in this
document, or if the data requirements  for registration (or the guidelines for generating  such
data) change.   ..;,,.'            .    .  •

     1.     Uses Eligible or Not Eligible at This Time

            The Agency has  determined that all uses of propamocarb hydrochloride,  with
     modifications specified herein, and with  the exception of the field-grown ornamental use
     plus the high volume/low pressure and hand dipping application scenarios, are eligible for
     reregistration.  A decision on the field-grown ornamental use plus the high volume/low
     pressure and hand dipping application scenarios  cannot be made at this time due to data
     deficiencies.   The registrant has  requested  the Agency  to remove  the field-grown
     ornamental use from its registration.

B.  Regulatory Position

     The Agency conducted its risk assessment of propamocarb hydrochloride based on the
currently registered use patterns and  available data.  The  following is  a summary of the
regulatory positions and rationales for propamocarb hydrochloride. Where labeling revisions
are imposed, specific language is set, forth in  Section V of this document.   ..  .

     1.    Use Deletion; Application Rate Reduction

            During the drafting of this document, the registrant had submitted to EPA a
     proposal to amend their label by deleting the use  of propamocarb hydrochloride for field
     grown ornamentals and limiting  the use  of the fungicide to  0.57 Ib  ai/1000 sq.  ft.
     (equivalent to  25 Ib ai/acre/year) of turfgrass per year.   These modifications will reduce
     ecological exposures and risks. They also eliminate the  requirements for a fish-life cycle
     ,and honey bee toxicity. studies.  The Agency will not require these studies for the
     remaining uses.  However, if the propamocarb hydrochloride registration changes in the
     future, the Agency may impose these data requirements.    .
                                          41

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 2.     Generic Data Gaps

       As discussed in Section III.B,  the Agency sees  a need  for  additional  data.
 Requirements for mixer/loader/applicator (i.e., handler) exposure studies are addressed
 in Subdivision U of the Pesticide Assessment Guidelines.  Review of available exposure
 data for other pesticides indicates that these data still are not warranted for most scenarios.
 However, there are several scenarios for which there  are no exposure data available,
 including application by high volume/low-pressure sprayers, by hand-dipping, and by
 sprinkling can.  Therefore, EPA is requiring exposure data for the high volume/low-
 pressure spray equipment and for hand-dipping.  For application by sprinkling can, the
 Agency anticipates that the amount of product handled using this technique would be less
 than that in the garden-hose-end scenario.  Therefore, data are not required for  application
 using a sprinkling can.

       The available data  on post-application exposure from  pesticides are limited.
 Additional post-application/reentry exposure studies on propamocarb hydrochloride are
 required  as  confirmatory  data to  determine  definitive  REIs  for  sod-farm  and
 greenhouse/nursery use sites.  The interim REI established in the document (24 hours) will
 be  adjusted, if necessary,  upon Agency review  of the additional  data.  In addition,
 confirmatory studies are required to determine the post-application  exposure following
 applications to turfgrass at residential sites. Requirements for post-applications/reentry
 exposure studies are addressed by Subdivision K of the Pesticide Assessment Guidelines.

       Although gaps in the database as described above  preclude the Agency  from
 quantifying risk  estimates for these scenarios, the Agency does not believe there are
 unreasonable risks during the time interval required to obtain these additional data. These
 data will be used to confirm its assumption of no unreasonable risks to handlers and those
 to enter treated sites.  Data are not required for the  other post-application exposure
 scenarios because it is anticipated that the exposure levels from these uses are lower than
 those in the greenhouse/nursery ornamental and two turfgrass scenarios.

       Likewise, as noted in Section m.C, the missing data addressing potential chronic
 hazard  to birds,  aquatic invertebrates, plants  and the environmental fate  studies'
 deficiencies preclude conducting definitive chronic risk assessments for these  non-target
 organisms.   To  address  this, the Agency has directed the registrant to submit the
 appropriate  studies. Although the Agency is anxious to address the potential  for risk to
 these organisms,   the Agency  has  decided   that in  consideration of propamocarb
 hydrochloride's known environmental fate and use characteristics, a finding of no
 unreasonable risk may be made at this time in the belief that when the missing information
 is evaluated it is not likely to be of a magnitude to change the basic  regulatory findings
 expressed in this document.

3.     Endangered Species
                                    42

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       The LOCs have been exceeded for birds and mammals for the use of propamocarb
hydrochloride on turf and field grown ornamentals. In addition, the LOCs for endangered
marine animals (mollusks) have been exceeded for field-grown ornamentals. Application
to woody ornamentals may also exceed endangered species LOC's depending on the
application rate used. The registrant's proposed use deletion for field grown ornamentals
and limiting the use of the fungicide to 0.57 Ib  ai/100 sq. ft. of turfgrass. per year will
mitigate these ecological exposures and risks.               .

4.     Labeling Rationale

Scope of the Worker Protection Standards

       The 1992  Worker  Protection  Standard for Agricultural  Pesticides  (WPS)
established certain worker-protection requirements (personal protective equipment [PPE],
restricted entry intervals  [REI], etc.) to be specified on the label of all products that
contain .uses .within the scope of the WPS.  Uses within the scope of the WPS include all
commercial (non-homeowner)  and  research uses  on farms,  forests,  nurseries, and
greenhouses to produce agricultural plants  (including food, feed, and fiber plants, trees,
turf grass,  flowers, shrubs, ornamentals, and  seedlings).. Uses within scope include not
only uses on plants, but also uses on the soil or planting medium the plants are (or will be)
grown in.                ..                ,                       ......

       At this time, some of the registered uses of propamocarb hydrochloride are within
the scope of the WPS and some uses are  outside the scope of the WPS.  Propamocarb
hydrochloride uses  within the WPS include:

       • plants grown for commercial or  research purposes, .
 :      / • turf grown for commercial (sod  farms) or  research purposes.

Those that are outside the scope of the WPS include:                       ,  :

       •      plants grown for other than  commercial or research purposes, which may
              include plants  in habitations, and home greenhouses,

       «      plants, including turf, that are in. ornamental gardens, parks, golf courses,
              and  public or private lawns and grounds and that  are intended  only  for
              decorative or environmental benefit.

Compliance With  The WPS

              Any product whose labeling  reasonably permits use in the production of an
       agricultural plant on any farm, forest, nursery, or greenhouse must comply with
       the labeling requirements of PR Notice 93-7, "Labeling Revisions  Required by the
       Worker Protection  Standard (WPS),  and  PR  Notice 93-11,  "Supplemental
                                     43

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       Guidance for PR Notice 93-7, which reflect the requirements of EPA's labeling
       regulations for worker protection statements (40 CFR part 156, subpart K).  These
       labeling revisions are necessary to implement the Worker Protection Standard for
       Agricultural Pesticides (40 CFR part 170) and must be completed in accordance
       with, and within the deadlines specified in, PR Notices 93-7 and  93-11. Unless
       otherwise specifically directed in this RED, all statements required by PR Notices
       93-7 and 93-11 are to be on the product label exactly as instructed in those notices.

       •      except as otherwise provided in PR Notices 93-7 and 93-11, all products
              within the scope of those notices must bear WPS PR Notice complying
              labeling when they are distributed or sold by the primary registrant or any
              supplementary registered distributor.

       •      After October 23, 1995, except as otherwise provided in PR Notices 93-7
              and 93-11, all products within the scope of those notices must bear WPS
              PR Notice complying labeling when they are distributed or sold by any
              person.

Personal Protective Equipment/Engineering Controls for Handlers

       At this time, there are no engineering control requirements, such as closed systems,
currently   required  on labeling  of the  end-use  product  containing  propamocarb
hydrochloride.  However, current labeling requires workers to wear long-sleeved shirt and
long pants, waterproof gloves and shoes plus socks.

Occupational-Use Products

       For each end-use product, personal protective equipment/engineering control
requirements for pesticide handlers will be set during reregistration in one of two  ways:

       1.  If EPA has no special concerns about the acute or other adverse effects of an
       active ingredient, the personal protective equipment (PPE) for pesticide handlers
       will be based on the acute toxicity of the end-use product.  For occupational-use
       products, PPE will be established using the process described in PR Notice 93-7
       or  more recent EPA guidelines.

       2.  If EPA has special concerns about an active ingredient due to very high acute
       toxicity or to certain other adverse effects,  such as allergic effects or delayed
       effects (cancer, developmental toxicity, reproductive effects, etc):

       •      In the RED for that active  ingredient,  EPA may establish minimum or
              "baseline" handler PPE or engineering-control requirements that pertain to
              all or most occupational end-use products containing that active ingredient.
                                    44

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       •      These minimum PPE requirements must be compared with the PPE that
              would be designated on the basis  of the acute toxicity of each end-use
              product.

       •      The more stringent choice for each  type of PPE (i.e., bodywear,  hand
              protection., footwear, eyewear, etc.) must be placed on the label of the end-
           .   use product.

        Because the Agency has concluded there is a toxicity end-point for short and
intermediate term occupational/residential exposure, which is beyond the acute toxicity of
propamocarb hydrochloride, it is prudent to establish  an- active ingredient based minimum
PPE/engineering control requirements for occupational handlers.  Mixers/loaders for
groundboom applications must wear chemical-resistant gloves in addition to long-sleeve
shirts, long pants, shoes plus socks.  For all other  handler scenarios, PPE/engineering
control requirements will be based on the acute toxicity of the end-use product.

Post-Application/Entry Restrictions

Occupational-Use Products (WPS Uses)

Restricted-Entry Interval:

        EPA  has no basis at  this  time  to establish a product-specific restricted-entry
interval due to the lack of foliar dislodgeable residue dissipation, dermal passive dosimetry
exposure,  and inhalation passive dosimetry exposure data for residential or commercial
use sites.  These data are necessary for the Agency  to definitively calculate the REIs for
all use sites for which interim REIs have been established under the WPS.

       Under the WPS, interim REI for all uses  within the  scope of the WPS are based
on the acute  toxicity of the  active ingredient.  The toxicity categories of the active
ingredient for acute dermal toxicity, eye irritation potential, and skin irritation potential
are used to determine the interim WPS REI.  If one or more of the three acute toxicity
effects are in toxicity category I, the interim WPS  REI is established at 48 hours. If none
of the acute toxicity effects are in  category I, but one or more of the three is classified as
category II, the interim WPS REI is established at  24 hours.  If none of the three acute
toxicity effects are in category I or II, the interim WPS REI is established at 12 hours. A
48-hour REI  is increased to 72 hours  when an organophosphate pesticide is applied
outdoors in arid areas.   In addition,  the WPS specifically retains two types  of REI's
established by the Agency prior to the  promulgation of the WPS: (1) product-specific
REI's established on the basis of adequate data, and (2) interim REI's that are longer than
those that would be established under the WPS.

        For propamocarb hydrochloride, the Agency believes it is appropriate to set the
interim REI for a longer period than that based on the acute toxicity of the chemical (12
                                     45

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 hours).  Since the Agency has identified toxicological endpoints of concern for short term
 and intermediated term occupational/residential exposure and post-application exposure
 data are not available, EPA is establishing a 24-hour REI and requiring data to confirm
 that the 24-hour REI will not result in unacceptable post-application exposure to persons
 reentering areas treated with propamocarb hydrochloride.

 Early-Entry PPE:

       The WPS establishes very specific restrictions on entry by workers to areas that
 remain under a restricted-entry interval if the entry involves contact with treated surfaces.
 Among the restrictions for workers entering treated areas is a prohibition of routine entry
 to perform hand labor tasks and requirement that personal protective equipment be worn.
 Personal protective equipment requirements for persons who must enter areas that remain
 under a restricted-entry interval are based  on the toxicity concerns about the active
 ingredient. The requirements are set in one of two ways.

       1.     If EPA has no special concerns about the acute or other adverse effects of
              an active ingredient, it establishes the early-entry PPE requirements based
              on the acute  dermal toxicity,  skin irritation potential, and eye irritation
              potential of the active ingredient.

       2.     If EPA  has special concerns about an  active  ingredient due to very high
              acute toxicity or to certain  other adverse effects, such as allergic effects,
              cancer,  developmental toxicity,  or reproductive effects, it  may establish
              early-entry  PPE requirements that  are more  stringent  than would  be
              established otherwise.

       Since  EPA has identified toxicological endpoints of  concern for short term and
 intermediate term occupational/residential  exposure for propamocarb hydrochloride, the
 Agency is establishing PPE for dermal protection that is more stringent than the PPE that
 would otherwise be established based on the acute toxicity of the active ingredient. The
 PPE  required for early entry is:   coveralls over short-sleeve shirt and short pants,
 chemical-resistant footwear  plus  socks,   chemical  resistant  headgear  for overhead
 exposures,  and chemical-resistant gloves. Since  propamocarb hydrochloride is classified
 as toxicity category in for eye irritation potential, no protective eyewear is required.

 NonWPS Uses

        Since EPA  has concerns about  immediate  (before sprays have dried) post-
 application exposures to persons from occupational uses outside the scope of WPS (turf,
 golf courses,  residential lawns,  and other recreational areas) it  is establishing entry
 restrictions for all nonWPS uses of propamocarb hydrochloride end-use products.  The
Agency is requiring that such treated sites be dry before reentry. The Agency believes a
24-hour restriction, as it is imposing for the  other uses,  is not  practical or feasible for the
                                     46

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V.
sites of golf courses, other recreational areas and home lawns.  When the Agency reviews
the required confirmatory data specified above, it will adjust this REI as appropriate.

5.     Additional Labeling Requirements

       The Agency is requiring additional labeling statements to be located on all end-use
products containing propamocarb hydrochloride. For the specific labeling statements, refer
to Section V of this document.

       ACTIONS REQUIRED OF REGISTRANTS
  This section specifies additional data requirements, label changes, and any other modifications
necessary for the reregistration of both manufacturing-use and end-use products.
       A.
              Manufacturing-Use Products
                    1.
                           Additional Generic Data Requirements
             As noted throughout this document, the Agency has identified studies for which
       additional information is needed and identified new studies which must be conducted.
       EPA believes these additional data are important for it to have a more comprehensive
       characterization of the potential hazards and exposures from propamocarb hydrochloride
       uses. In addition, the Agency will use these data to confirm the above estimated risks and
       its regulatory decision.   Outstanding data have been  required of the propamocarb
       hydrochloride registrant.   The  two  required studies necessary  to provide data on
       applicators during ground applications using high volume/low pressure spray equipment
       (commercial turfgrass)  and for  hand-dipping (ornamental) applications are-a dermal
       exposure  study, and an inhalation exposure study.  These studies should be conducted
       concurrently; i.e., dermal  and inhalation  samples  should be  collected  from the same
       worker and at the same site during each trial.   Foliar residue dissipation, post-application
       dermal passive dosimetry exposure and post-application inhalation dosimetry exposure are
       required.  However, the post-application dermal passive dosimetry exposure and post-
       application inhalation dosimetry exposure studies for residential turf may be reserved at
       this time  pending completion of the databases on  agricultural and residential post-
       application/reentry exposure currently being developed by the Agricultural Reentry Task
       Force and Outdoor Exposure Task Force, provided the registrant is a member of both
       Task Forces.  In addition, the Agency has required avian reproduction,  chronic aquatic
       invertebrate toxicity, aquatic plant growth, and seedling emergence.

              The Agency has  also identified deficiencies in studies addressing gene mutation,
       avian dietary, aquatic  invertebrate life-cycle, hydrolysis, anaerobic metabolism, and
       terrestrial field dissipation.  The registrant has been notified under a separate letter to
       upgrade these studies or to submit new studies.
                                           47

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              2.     Labeling Requirements for Manufactured Use Products

       To remain in compliance with FIFRA, manufacturing use-product (MP) labeling
must be revised to comply with all current EPA regulations, PR Notices and applicable
policies.  The MP labeling must bear the following statement under Directions For Use:

       "Only for formulation into a fungicide for the following use(s): ornamental sod
       farms (turf), ornamental lawns and turf, ornamental herbaceous plants,  ornamental
       woody shrubs and vines, cutting beds, and seedling areas."

       An MP registrant may, at his/her discretion, add one of the following statements
to an MP label under "Directions for Use" to permit the reformulation of the product for
a specific use or all additional uses supported by a formulator or user group:

       (a)     "This product may be used to formulate products for specific use(s)
              not listed on the MP label if the formulator,  user group, or grower
              has complied with U.S.EPA submission requirements regarding the
              support of such use(s)."

       (b)     "This product may be used to formulate products for any additional
              use(s) not listed on the MP label if the formulator, user group, or
              grower  has complied with U.S.  EPA  submission requirements
              regarding the support of such use(s)."

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.
The product specific data requirements are listed in Appendix F, the Product Specific Data
Call-in Notice.

       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
                    a.     PPE Requirements for Pesticide Handlers

             Sole  active  ingredient  end-use  products  that  contain  propamocarb
                                    48

-------
hydrochloride must be revised to adopt the handler PPE requirements set forth in
this section. Any conflicting PPE .requirements on the current labeling must be
removed.                         .      .

       Multiple active  ingredient end-use products that contain propamocarb
hydrochloride  must compare  the handler  personal  protective equipment
requirements set forth in this section to the PPE requirements  on the current
labeling and retain the more protective. For guidance on which PPE is considered
more protective, see PR Notice 93-7.                                •

       Products Intended for Occupational Use

       Minimum PPE requirements (WPS and nonWPS uses): The minimum
PPE for all WPS and nonWPS uses for which groundboom applications can be
employed is:

       ."For groundboom applications, mixers and loaders must wear long-
       sleeved shirt and long pants, chemical-resistant gloves, and shoes
       plus socks".

       The  glove requirement for propamocarb hydrochloride is the statement
established through the instructions  in Supplement Three of PR Notice 93-7.

       PPE requirements for all other WPS and nonWPS uses: The PPE for
all other WPS and nonWPS uses will be based on the acute toxicity of the end-use
product.  This PPE must be compared to the minimum (baseline) (PPE).  The
more protective PPE must be placed on the product labeling. For guidance on
which PPE is considered more protective, see PR Notice 93-7.

       Placement in labeling: The PPE must be placed on the end-use product
labeling in the location  specified in  PR Notice 93-7 and the format and language
of the PPE requirements must be the same as is specified in PR Notice 93-7.

b.     Reentry Requirements

       Reentry Interval (REI for WPS uses): A 24-hour REI is required for uses
within the scope  of the WPS  (see PR Notice 93-7) on all end-use products (see
tests  in  PR Notices 93-7  and  93-11).  This  REI must be inserted  into the
standardized REI statement required by Supplement Three of PR Notice 93-7.

       Early reentry PPE requirements: The PPE label language required for
early entry into WPS treated sites is:
                             49

-------
        "For early entry, wear coveralls over short-sleeve shirt and short
        pants, chemical-resistant gloves, chemical-resistant footwear plus
        socks, and chemical-resistant headgear for overhead exposures."

        WPS Notification Statement (WPS uses): The following statement must
 be added to all end-use product labeling that contain directions for one or more
 WPS uses:

        "Notify workers of the application by warning them orally and by
        posting warning signs at entrances to treated areas."

        Placement in labeling: The REI must be inserted into the standardized REI
 statement required by Supplement Three of PR Notice 93-7. The PPE required for
 early entry must be  inserted into the standardized early entry  PPE  statement
 required  by Supplement Three  of  PR Notice 93-7. The  double  notification
 statement must be inserted  into the  Agricultural Use Requirements box in  the
 location required by Supplement Three of PR Notice 93-7.

       Entry restrictions for NonWPS uses: The Agency is establishing  the
 following entry restrictions  for all nonWPS occupational uses of propamocarb
 hydrochloride end-use products:

        "Do not enter or allow others  to enter the treated area until sprays
       have dried."

       Placement in labeling:

       If WPS uses are also on label, then follow the instructions in PR Notice 93-
7  for establishing a  Non-Agricultural Use  Requirements box  and place the
appropriate nonWPS entry restriction in that box. If no WPS  uses are on label
then add  the appropriate nonWPS entry restriction to the labels of all end-use
products, except products primarily intended for homeowner use, in a section in
the Directions For Use with  the heading:

       "Entry Restrictions:"
c.
Engineering controls
       The  following  engineering  control  statement  is required on  product
labeling:

       "When handlers  use closed systems, enclosed cabs, or aircraft in a
       manner that meets the requirements listed in the Worker Protection
       Standard (WPS)  for agricultural pesticides (40 CFR 170.240(d)(4-
                             50

-------
       6), the handler PPE requirements may be reduced or modified as
      • specified in the WPS."

d.     Application restrictions

       These additional use  restrictions are required  for propamocarb
hydrochloride labels:               .

       "Do not apply this product in a way that will contact workers, other
       people or pets, either directly or from drift.  Keep people and pets
       out of the area during application. Only protected handlers may be
       in the area during application"

     .  "Do  not apply more than a total of 12 fl. oz. (equivalent to 0.57
       Ib/ai) of propamocarb hydrochloride per  1000 sq. ft.  (25  Ibs
    .  , ai/acre/year) of turfgrass per year."

       "Do  not use for field-grown ornamentals."

e.     User safety requirements

       Add  the following user safety requirement to the end-use product labeling
ONLY if PPE (other than long-sleeve shirt, long pants, shoes,  and socks) are
required on  the label due to the acute toxicity of the end-use product:

       "Follow  manufacturer's  instructions  for cleaning/maintaining
       protective clothing and equipment.  If there are  no such instructions
       for washables, use detergent and  hot  water.   Keep  and wash
       protective clothing and equipment separate from other laundry."

f. .-   User safety recommendations

•     "Users should wash hands before eating, drinking, chewing gum,
       using tobacco, or using the toilet."

•     "Users  should remove clothing immediately if pesticide  gets
       inside.  Then wash thoroughly and put on clean clothing."

       Add the following user  safety recommendation to the end-use product
labeling ONLY if PPE (other than long-sleeve shirt, long pants,  shoes, and socks)
are required on the label due to the  acute toxicity of the end-use product:

•     : "Users. should  remove  protective -clothing  and  equipment
       immediately after handling  this product.  Wash the  outside of
                              51

-------
     c.
gloves before removing. As soon as possible, wash thoroughly
and change into clean clothing."

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  propamocarb
hydrochloride 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.
                                         52

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VI. APPENDICES

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                                        GUIDE TO APPENDIX B
 Appendix B contains listings of data requirements which support the reregistration for active ingredients within the case
 3ropamocarb Hydrochloride covered by this Reregistration Eligibility Decision Document. It contains generic data
[requirements that apply to Propamocarb Hydrochloride 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 (Column 1).  The data requirements are listed in the order in which they appear in 40 CFR
 art 158.  the reference numbers accompanying each test refer to the test protocols set in the Pesticide Assessment
  uidelines, which are available from the National Technical Information Service, 5285 Port Royal Road,  Springfield,
  A 22161 (703)  487-4650.

  2.  Use  Pattern (Column 2). This column indicates the use patterns for which the data requirements apply. The
 ollowing 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 (Column 3).  If the Agency has acceptable data in its files, this column lists the identifying
 umber of each study. This normally is the Master Record Identification (MRID) number, but may be a  "GS" number
 f no MRID number has been assigned.  Refer to the Bibliography appendix for a complete citation of the study.
                                                    57

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                               GUIDE TO APPENDIX C

1.     CONTENTS OF BIBLIOGRAPHY.  This bibliography contains citations of all studies
       considered relevant by EPA in arriving at the positions and conclusions stated
       elsewhere in the Reregistration Eligibility Document.  Primary sources for studies in
       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, in those instances where they have been considered,
       are included.

2.     UNITS OF ENTRY. The unit of entry in this biblipgraphy 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.

3.     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 in 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.

4.     FORM OF. ENTRY.  In addition to the Master Record Identifier (MRID), each entry
       consists of a citation containing standard elements followed, in 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.

  a    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.

  b.    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.

  c.    Title.  In some cases, it has been necessary for the Agency bibliographers to create or
       enhance a document title. Any such editorial insertions are contained between square
       brackets.
                                          65

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d.   Trailing parentheses. For studies submitted to the Agency in the past, the trailing
     parentheses include (in addition to any self-explanatory text) the following elements
     describing the earliest known submission:

     (1)     Submission date.  The date of the earliest known submission appears
            immediately following the word "received."

     (2)     Administrative number. The next element immediately following the word
            "under" is the registration number, experimental use permit number, petition
            number, or other administrative number associated with the earliest known
            submission.

     (3)     Submitter. The third element is the submitter.  When authorship is defaulted to
            the submitter, this element is omitted.

     (4)     Volume Identification (Accession Numbers). The final element in the trailing
            parentheses identifies the EPA accession number of the volume in which the
            original submission of the study appears. The six-digit accession number
            follows the symbol  "CDL," which  stands for "Company Data Library."  This
            accession number is in turn followed by an alphabetic suffix which shows the
            relative position of  the study within the volume.
                                         66

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                                BIBLIOGRAPHY
 MRID
CITATION
00101637    Allen, P. (1982) Effect of Previcur N on Reproductive Function of Multiple
             Generations in the Rat: Reprotox Order No.  126.  Final rept.  (Unpublished
             study received May 18,  1982 under 2139-121; prepared by Huntingdon
             Research Centre, W. Ger., submitted by  Nor-Am Agricultural Products, Inc.,
             Naperville, IL; CDL: 247524-A)

00101638    Hunter, B.; Jones, D.; Heywood, R.; et aL (1981) Previcur N (SN66 752):
             Toxicity and Potential Tumorigenicity in  Dietary Administration to Rats for 104
             Weeks:  HRC Report No. SHG/165-G/801056.  Final rept. (Unpublished study
             received May 18, 1982 under 2139-121; prepared by Huntingdon Research
             Centre,  Eng., submitted by Nor-Am Agricultural Products, Inc.,  Naperville,
             IL;CDL:247526-A; 247527)

00101639    Nor-Am Agricultural Products, Inc.  (1982) Toxicology: Propamocarb
             hydrochloride: Teratology and Mutagenicity-Summary. Summary of studies
             247529-C through 247529-F. (Unpublished study received May 18, 1982 under
             2139-121; CDL:247529-A)

00101640    Kuhne, G.; Aner, B.; Klawa, D.; et al. (1978) Pharmacokinetics  of
             Propamocarb-hydrochloride on Single and Repeated Oral Administration of 0.5
             mg/kg in Rats: Report No. SN 66752-9/5. (Unpublished study received May
             18, 1982 under 2139-121; prepared by Schering AG, W. Ger., submitted by
             Nor-Am Agricultural Products, Inc., Naperville, IL; CDL:247529-B)

00101641    Poggel,  H. (1981) Previcur N (CP 604)~Embryotoxicity Including
             Teratogenicity Study in Rats after Daily Intragastric Administration from 6 to
             Day 19 of Gestation: Report No.  PF 62/87. (Unpublished study received May
             18, 1982 under 2139-121; prepared by Schering AG, W. Ger., submitted by
             Nor-Am Agricultural Products, Inc., Naperville, IL; CDL:247529-C)

00101642    Hossack, D.; Richold, M.; Richardson, J. (1980) Micronucleus Test on CP 604
             (SN 66752, Previcur N): SHG 182/79183. (Unpublished study received May
             18, 1982 under 2139-121; prepared by Huntingdon Research Center,  Eng.,
             submitted by Nor-Am Agricultural Products,  Inc., Naperville, IL;
             CDL:247529-D)

00101643    Hossack, D.; Richold, M.; Richardson, J. (1980) Micronucleus Test on CP 604
             (SN66752, Previcur N):  SHG 191/79737.  (Unpublished study received May
             18, 1982 under 2139-121; prepared by Huntingdon Research Center, Eng.,

                           .             67

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                               BIBLIOGRAPHY
MRID
CITATION
             submitted by Nor-Am Agricultural Products, Inc., Naperville, IL;
             CDL:247529-E)

00101644    Rushbrook, C.; Jorgenson, T.; Spanggord, R.; et al. (1979) Dominant Lethal
             Study of Previcur N: SRI Project LSC-8516.  Final rept. (Unpublished study
             received May 18, 1982 under 2139-121; prepared by SRI International,
             submitted by Nor-Am Agricultural Products, Inc., Naperville, IL;
             CDL:247529-F)

00101645    Jagannath, D.; Hoorn, A.; Goode, S. (1980) Previcur N: Mutagenicity
             Evaluation in Yeast.  (Unpublished study received May 18, 1982 under
             2139-121; prepared by Schering AG, W. Ger., submitted by Nor-Am
             Agricultural Products, Inc., Naperville, IL; CDL:247529-G)

00109212    Hunter, B.; Watson, M.; Read, R.; et al. (1981) Previcur N (SN 66752):
             Potential Tumorigenicity to Mice in Dietary Administration for 104 Weeks:
             HRC Report No. SHG 164/80965.  Final rept. (Unpublished study received
             May 18, 1982 under 2139-121; prepared by Huntingdon Research Centre,
             Eng., submitted by Nor-Am Agricultural Products,  Inc., Naperville, IL;
             CDL:247525-A; 247528)

00109540    Riemann, J.; Hoyer, G.; Klehr, M.; et al.  (1980) Qualitative and Quantitative
             Analysis of ... NDMA in Some Batches of Previcur N (70% Aqueous Solution
             of Propamocarb.HCl, SN 66752) and the Precursor Compound ...  Diamine:
             APC 25/80, SPQ 24/80.  Unpublished  study; 29 p.

00118416    Frank,  G. (1978) Determinations of Cholinesterase  Activity in Plasma,
             Erythrocytes, and Brain of Experimental Animals with a Centrifugal Analyzer.
             (Presented at the X International Congress of Clinical Chemistry; Mar 2, 1978;
             Mexico City, Mex.;  unpublished study received Nov 16, 1982 under 2139-121;
             prepared by Bayer, AG, submitted by Nor-Am Agricultural Products, Inc.,
             Naperville, IL; CDL:248884-A)

00125237    Nor-Am Agricultural Products, Inc. (1983) Toxicology-Propamocarb
             Hydrochloride: Dogs, Rats.  (Compilation; unpublished study received Jan 13,
             1983 under 2139-121; CDL:249252-A)

00125238    Kojima, K.; Enomoto, M.; Okamura, T.; et al. (1982) Three-month
             Subchronic Oral Toxicity Study in Rats: Report No. 217.  (Unpublished study

                                         68

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                               BIBLIOGRAPHY
MRID
CITATION
             received Jan 13, 1983 under 2139-121; prepared by Biosafety Research Center,
             Japan, submitted by Nor-Am Agricultural Products, Inc., Naperville, IL;
             CDL:249253-A)

00130267     Bhargava, A.; Kopp, R.; Gunzel, P.; et al. (1981) Influence upon the
             Acetylcholinesterase Activity in vitro (Dog and Rat) and in vivo (Dog) after
             Single Oral Administration: Previcur N: Prot. No. TX 81.060: Report No. PF
             39/81.  (Translation; unpublished study received Sep 20,  1982 under 2139-121;
             prepared by Schering AG, W. Ger., submitted by Nor-Am Agricultural
             Products, Naperville, IL; CDL:248355-A)

41278100     Nor-Am Chemical Co. (1989) Submission of Chemistry, Toxicity, Residue,
             Metabolism and Phytotoxicity Data in Support of Propamocarb HCL.
             Transmittal of 32 studies.

41278101     Baude, G.; Klehr, M. (1979) C6 Propamocarb HCL: Qualitative and
             Quantitative Analysis of N- nitrosodimethylamine (NDMA) in Previcur N
             (aqueous solution of Propamocarb HCL, SN 66  752): Lab Project Number:
             SPQ/22/79/APC/23/79.  Unpublished study prepared by  Schering AG  15 p.

41278102     Klehr, M.; Schneider, P. (1980) C8 Propamocarb HCL: Synthesis of Possible
             Non-Volatile N-Nitroso Compounds Derived from Propamocarb HCL (66 752)
             and Analysis of These Compounds in Previcur N (70% Aqueous Solution of
             Propamocarb):  Lab Project Number: APC/43/80.  Unpublished study
             prepared by Schering AG 20 p.

41278103     Muller, T. (1988) C39 Solubility of Propamocarb-Hydrochloride in Water at 20
             Degree C:  Lab Project Number: 88/102.  Unpublished study prepared by
             Schering AG 47 p.

41278104     Miklautz, H. (1985) C5-Propamocarb HCL: The Determination of the Vapour
             Pressure of SN 66 752: Propyl3-(Dimethylamino)propyl-carbamate
             Hydrochloride: Lab Project Number: APC/37A/77.  Unpublished study
             prepared by Schering AG. 7 p.

41278105     Miklautz, H. (1980) C14-Propamocarb: The Temprature Dependence of the
             Vapor Pressure of SN 66 752;  Lab Project Number: APC/03/80.  Unpublished
             study prepared by Schering AG.  8 p.
                                        69

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                               BIBLIOGRAPHY
MRID
CITATION
41834600    NOR-AM Chemical Co. (1991) Submission of Data To Support Propamocarb
            HCL Reregistration: Product Chemistry and Toxicology Studies. Transmittal
            of 8 studies.

41834601    Muller, T.; Lehne, V.; Steib, C.; et al. (1990) Propamocarb HCL:Product
            Chemistry Study: Lab Project Number: 90/193/1: 89/050/1: 90/077/2.
            Unpublished study prepared by Schering Ag. 292 p.

41834602    Wuthric, V. (1990) Previcur N Propamocarb-HCL Techn: 21-Day Prolonged
            Toxicity Study Rainbow Trout Under Flow-through Conditions: Lab Project
            Number: 223086: TB 88032.  Unpublished study prepared by RCC
            Umweltchemie Ag.  49 p.

41834603    Schnupner, J. (1991) The Static Acute Toxicity of Propamocarb-HCL to the
            Sheepshead Minnow, Cyprinodon variegatus: Lab Project No:504AV.
            Unpublished study prepared by NOR-AM Chemical Co., Research Center. 43
            P-

41834604    Schupner, J. (1991) The Static Acute Toxicity of Propamocarb-HCL to the
            Mysid Shrimp, Mysidopsis bahia: Lab Project Number: 500AV. Unpublished
            study prepared by NOR-AM Chemical Co., Research Center.  39 p.

41834605     Downey,  S. (1991) Investigation into the Phytotoxic Effects of
             Propamocarb.HCL on Seed Germination (Tier 1): Lab Project No: 505 AV.
             Unpublished study prepared by NOR-AM Chemical Co. 45 p.

41834606     Downey,  S. (1991) Investigation into the Phytotoxic Effects of
             Propamocarb.HCL on Seedling Emergence (Tier 1):  Lab Project No:506/AV.
             Unpublished study prepared by NOR-AM Chemical Co. 62 p.

41834607     Downey,  S. (1991) Investigation into the Phytotoxic Effects of
             Propamocarb.HCL on Vegetative Vigor (Tier 1): Lab Project No: 507/AV.
             Unpublished study prepared by NOR-AM Chemical Co. 90 p.

41834608     Tschampel, M. (1990) W78 Propamocarb: The Photodegradation of
             Propamocarb Hydrochloride (Schering Code ZK 66 752) on Soil Surfaces: Lab
             Project Number: APC/87/90.  Unpublished study prepared by Schering Ag.  44
             P-
                                        70

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                               BIBLIOGRAPHY
MRID
CITATION
42145000     Nor-Am Chemical Co. (1990) Submission of New Study Which Was Part of
             Phase 3 Package: Propamocarb HCL: Acute Inhalation Toxicity. Transmittal of
             1 study.

42145001     Schuh, W. (1990) Propamocarb HCL: Previcur N (CP 604; ZK 6752): Acute
             Inhalation Toxicity Study in the Rat (M+F, 4 h Exposure): Revised Final
             Report: Lab Project ID: TX 76.159; T7/2.  Unpublished study prepared by
             Schering AG Experimental Toxicology.  19 p.

42421200     Nor-Am Chemical Co. (1992) Submission of toxicity and environmental fate
             data to support the reregistration of Propamocarb HCL. Transmittal of 2
             studies.

42421201     Healing, G.  (1992) T80 Propamocarb HCL: Previcur N (Propamocarb
             Hcl)—Rat  21-Day Dermal Repeat Dose Study: Lab Project
             Number:TOX/92/186-16: 91235. Unpublished study prepared by Schering Ag.
             Ltd. 128  p.

42421202     Wrede-Rucker, A. (1992) W115 Propamocarb HCL: Dissipation of
             Propamocarb X HCL in Soil Following Application of Banol—USA 1990: Lab
             Project Number: UPSR 57/91: PF-R 89093. Unpublished study prepared by
             Schering Ag, Berlin.  83 p.

42567900     NOR-AM Chemical Co. (1992) Submission of toxicity data to support
             reregistration of Propamocarb. Transmittal of 4 studies.

42567901     Hakin, B. (1992) Previcur N SL: Bobwite Quail Acute Oral Toxicity (LD50)
             Study: Lab Project Number: SMS 406/921159.  Unpublished study prepared by
             Huntingdon  Research Centre Ltd.  25 p.

42567902     Hakin, B. (1992) Previcur N SL: Mallard Duck Subacute Dietary Toxicity
             (LC50) Study:  Lab Project Number: SMS 407/921085. Unpublished study
             prepared by Huntingdon Research Centre Ltd.

42567903     Hakin, B. (1992) Previcur N SL: Bobwhite Quail Subacute Dietary Toxicity
             (LC50) Study:  Lab Project Number: SMS 408/921086. Unpublished study
             prepared by Huntingdon Research Centre Ltd.  21 p.
                                        71

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                               BIBLIOGRAPHY
MRID
CITATION
42567904     Schupner, J.; Stachura, B. (1992) Propamocarb/Wl 11: The Acute Toxicity
             Propamocarb-HCl to Daphnia magna in a Static System: Lab Project Number:
             512AV.  Unpublished study prepared by Nor-AM Chemical Co.  41 p.

43013100     Nor-Am Chemical Co. (1993) Submission of Neurotoxicity Data in Support of
             Propamocarb-HCL Phase 4 Data Call-in. Transmittal of 2 Studies.

43013101     Ponnock, K. (1993) T86 Propamocarb: Rat Acute Oral Neurotoxicity Study:
             Range-finding Study: Lab Project Number: TOX/93/186-29: 92-4503:
             TOX/92271.  Unpublished study prepared by Pharmaco LSR Inc.  32 p.

43013102     Ponnock, K. (1993) T88 Propamocarb: Rat Subchronic (3-month)Dietary
             Neurotoxicity Study: Lab Project Number: TOX/93/186-31:92-4505:
             TOX/92006.  Unpublished study prepared by Pharmaco LSR Inc.  630 p.

43044200     Nor-Am Chemical Co. (1993) Submission of Toxicology Data in Supportof
             FIFRA 6(a)(2) for Propamocarb-HCL. Transmittal of 2 Studies.

43044201     Bathe, R.; Frei, T.; Luetkemeier, H.; et al. (1985) T-66 Propamocarb: 24
             Month Oral (Feeding) Study with Previcur N in Beagle Dogs: Lab Project
             Number: PF-81.812: 003688: 018617. Unpublished study prepared by Research
             & Consulting Co. AG. 784 p.

43044202     Jackson, C. (1993) T-66, Addendum 1: Propamocarb: Dog Two Year Dietary
             Toxicity "Relevance for Humans of Ocular Changes in Dogs". Unpublished
             study prepared by Schering Agrochemicals Ltd. 7 p.

43062300     Nor-Am Chemical Co. (1993) Submission of Acute Toxicology Data in Support
             of Propamocarb-HCl Reregistration. Transmittal of 1 Study.

43062301     Ponnock, K. (1993) T87 Propamocarb: Rat Acute Oral Neurotoxicity Study:
             Lab Project Number: TOX/93/186-30:92-4504. Unpublished study prepared
             by Pharmaco LSR Inc.  441 p.

43440900     AgrEvo USA Co. (1994) Submittal of Toxicity Data in Support of
             Reregistration of Propamocarb (BANOL).  Transmittal of 4 Studies.
                                        72

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                               BIBLIOGRAPHY
MRID
CITATION
43440901    Chisholm, K. (1994) Addendum 1 to T87 Propamocarb Rat Acute Oral
            Neurotoxicity: Lab Project Number: TOX/93/186-31. Unpublished study
            prepared by Pharmaco LSR Inc. 5 p.

43440902    Bright, J. (1994) Addendum 1 to T88 Propamocarb Rat Subchronic (3 Month)
            Dietary Neurotoxicity Study: Lab Project Number: TOX 92006.  Unpublished
            study prepared by AgrEvo UK Limited.  13 p.

43440903    Bright, J. (1994) Addendum 2 to T88 Propamocarb C113 Propamocarb:
            Propamocarb HC1 Aqueous Solution 71.1% Active Ingredient; Analytical
            Method for Rodent Diet: Lab Project Number: 067/01/001.  Unpublished study
            prepared by AgrEvo UK Limited.  29 p.

43440904    Auletta, C. (1994) Addendum 3 to T88 Propamocarb: Positive Control Data for
            Neurotoxicity Studies: Lab Project Number: TOX 92005/TOX 92006.
            Unpublished study prepared by Pharmaco LSR Inc.  51 p.

43619600    AgrEvo USA Co. (1995) Submission of toxicology data in support of
            propamocarb reregistration. Transmittal of 1 study.

43619601    Kojima, K.; Enomoto, M. (1982) T46 Propamocarb HC1 Previcur N: Three
            Month Sub-Chronic Oral Toxicity Study in Rats: Lab Project Number: 217.
            Unpublished study prepared by Biosafety Research Center (AN-PYO Center)
            and Schering AG. 582 p.

93193000    Nor-Am Chemical Company (1990) Reregistration Phase 3 Response:
            Propamocarb propyl 3-(dirnethylamino)propylcarbamate.

93193002    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 00071300. Qualitative and Quantitative Analysis of NDMA in Some
            Batches of Previcur N: APC 25/80; APC 24/80. 14 p.

93193003    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278102. Synthesis of Possible Non-volatile n-nitroso Compounds
            Derived from Propamocarb-HCL and Their Analysis in Previcur N (Banol):
            APC 43/80. 13 p.
                                        73

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                              BIBLIOGRAPHY
MRID
CITATION
93193004    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278101.  Qualitative and Quantitative Analysis of
            N-nitrosodimethylamine (NDMA) in Previcur N: SPQ 22/79; SPQ 23/79.  11
            P-

93193005    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278103 and Related MRIDs 41278107.  Physical and Chemical
            Characteristics of Propamocarb HC1 (Solubility in Water and Octanol/Water
            Partition Coefficient: C39 88/102; C2 APC05/76. 9 p.

93193006    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278108.  The Acute Toxicity (LD50) of ZK66752 to the Mallard
            Duck: Laboratory ID. No. SHG 153 - LW/77 833; (Wl).  Prepared by
            Huntingdon Research Centre. 10 p.

93193007    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278109.  Acute Oral (LD50) of ZK66752 to the Ring-Necked
            Pheasant: Laboratory I.D. No. SHG 153 - WL/77831; (W2). Prepared by
            Huntingdon Research Centre, lip.

93193008    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278111.  The Subacute Toxicity (LC50) of ZK66752 to the
            Ring-Necked Pheasant: Laboratory I.D. No. SHG -153 - WL/77741; (W4).
            Prepared by Huntingdon Research Centre, lip.

93193009    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278123 and Related MRIDs 41278124. Mutagenicity Evaluation of
            Previcur N in Yeast: Laboratory ID No. E9409. Prepared by Litton Bionetics.
            12 p.

93193010    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278110.  The Subacute Toxicity (LC50) of ZK66752 to the Mallard
            Duck: Laboratory I.D. No. SHG 155 - WL/77611; (W3).  Prepared by
            Huntingdon Research Centre. 16 p.

93193011    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278112.  Acute Toxicity of SN 66752 to Carp and Rainbow Trout:
            Laboratory I.D. No. SHG 156/77919; (W37). Prepared by Huntingdon
            Research Centre. 12 p.

                                       74

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                              BIBLIOGRAPHY
MRID
CITATION
93193012    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278113.  Acute Toxicity of SN 66752 to Bluegill and Rainbow
            Trout: Laboratory I.D. No. SHG/157/77754;(W38). Prepared by Huntingdon
            Research Centre. 13 p.

93193013    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 00047370.  The Acute Toxicity of SN 66752 (Previcur N) to the
            Water Flea; Laboratory I.D. No. 11506-74-05;(W41).  Prepared by UNION
            CARBIDE CORP. lip.

93193016    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278115.  Previcur N: Acute Oral Toxicity Study in Rats:
            Laboratory I.D. No. 226; (T53). Prepared by An-Pyo Center. 12 p.

93193017    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278116.  PROPAMOCARB HCL - Acute Percutaneous Toxicity
            Study in Rats: Laboratory I.D. No. 229; (T56).  Prepared by An-Pyo Center.
            lip.

93193018    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 93193044.  Acute Inhalation Toxicity to the Rat of Aqueous ZK
            66.752 Following Single 4 Hr. Continous Exposure (LC50): Laboratory I.D.
            Nos. PF 1/90 and TX 76.159; (T7/2). Prepared by Schering AG, Dept. of
            Experimental Toxicology. 14 p.

93193019    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278117.  PROPAMOCARB-HCI - Primary Eye Irritation after
            Single Application with Previcur N in the Rabbit: Laboratory I.D. No. 024333;
            (T47). Prepared by Research & Consulting Co. Ltd. 7 p.

93193020    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278118.  Propamocarb HCL - Primary Skin Irritation Following A
            Single 4-Hour Occlusive Application with Previcur N in the Rabbit: Laboratory
            I.D. 018393; (T48). Prepared by Research & Consulting Co.  Ltd. 7 p.

93193021    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 00083808.  Investigation of a Potential Sensitizing Effect of CP604 in
            Guinea Pigs: Laboratory I.D. 266/77;  (T29/2).  Prepared by Schering AG,

                                       75

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                              BIBLIOGRAPHY
MRID
CITATION
            Dept. of Experimental Toxicology. 10 p.

93193022    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 00125238. Three Month Subchronic Oral Toxicity Study in Rats:
            Laboratory I.D. 217; (T46). Prepared by An-Pyo Center. 11 p.

93193023    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278119. Subchronic (90-Day) Feeding Study with ZK17.296 in
            Dogs: Laboratory I.D. No.  R5178; (T32). Prepared by TNO, Central Institute
            for Nutrition and Food Research. 9 p.

93193024    Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary of MRID
            00101641.  Embryotoxicity Including Teratogenicity Study in Rats after Daily
            Intragastrical Administration from Day 6 to Day 19 of Gestation - Revised Final
            Report: Laboratory Project I.D. No. PF 24/90 (TX 80348 (T41/2).  Prepared
            by Schering AG. 9 p.

93193025    Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary of MRID
            00072574.  Embryotoxicity Including Teratogenicity Study in Rabbits After
            Daily Intragastrical Administration From Day 6 to Day 18 of Gestation -
            Revised Final Report: Laboratory Project I.D. PF 9/90 (TX 80122);  (T36/2).
            Prepared by Schering AG. 12 p.

93193026    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278120. PROPAMOCARB - PREVICUR N: Effect of
            Administration during Organogenesis on Fetuses of the Rabbit:Laboratory I.D.
            No. 143/A; (T35/2). Prepared by Huntingdon Research Centre. 14 p.

93193027    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278121. Microbial Metabolic Activation Test to Assess Mutagenic
            Potential: Laboratory I.D. Nos. TOX 87250;TOX/87/186-14; SMS 53/87627;
            (T70).  Prepared by Huntingdon Research Centre. 10 p.

93193028    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278122. Propamocarb-HCL: Metaphase  Chromosome Analysis of
            Human Lymphocytes Cultures in vitro: Laboratory I.D.  No. TOX 87249;
            TOX/87/186-13; SMS  54/87808; (T69).  Prepared by Huntingdon Research
            Centre. 11 p.
                                       76

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                              BIBLIOGRAPHY
MRID
CITATION
93193029    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 00071297. Determination of Rates of Hydrolysis of Propamacarb
            Base at pH 5,7, and 9 at 25 Degrees C:Laboratory I.D. No. APC 26/76 with.
            Addendum; W6. Prepared by Schering AG. 16 p.

93193030    Chow, N.; Stevens, N. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 00071296. Photolysis Experiment with Propamocarb HCL in Heat
            Sterilized Aqueous Solutions: (W8). Prepared by Schering AG. 23 p.

93193031    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278126. Degradation of Propamocarb-HCL in a California Loamy
            Sand: Laboratory I.D. No. R+S 29/79; (W13). Prepared by Schering AG. 15
            P-

93193032    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278127. PROPAMOCARB HCL - Degradation of Propamocarb
            HCL in a Loamy Sand: R+S 71/80 PA6752 71/6; (W15). Prepared by
            Schering AG. 16 p.

93193033    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278128. Degradation of Propamocarb - HCL in a Loamy Sand
            After Repeated Application: Laboratory I.D. No. UPSR1/86; PA66752.71;
            (W58). Prepared by Schering AG. 25 p.

93193034    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278125. Degradation of SN66752 in a Loamy Sand: Laboratory
            I.D. No. PA66752 71/6; (W12). Prepared by Schering AG. 23 p.

93193035    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
          .  of MRID 41278129. Degradation of SN66752 in a Loamy Sand under
            Anaerobic  Conditions: Laboratory I.D. No. PA 66752.71/6; W20.  Prepared
            by Schering AG. 22 p.

93193036    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 00071465. Anaerobic Degradation of Propamocarb Hydrochloride in
            River Sediment:  Laboratory I.D. No. R+S 60/80; PA66752 71/6; (W21).
            Prepared by Schering AG. 22 p.

93193037    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary

                                       77

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                               BIBLIOGRAPHY
MRID
CITATION
            of MRID 41278130. Adsorption to and Desorption from Soil: Laboratory I.D.
            No. UPSR 19/88; (W59).  Prepared by Schering AG. 28 p.

93193038    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278131. The Mobility of Propamocarb-HCL in Four Soils as
            Determined by Soil TLC: Laboratory I.D. No. UPSR 88/68; (W69).  Prepared
            by Schering AG. 22 p.

93193039    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 41278132. Mobility of Propamocarb-HCL in Four Soils: Laboratory
            I.D. No. PA66752 71/6; (W29). Prepared by Schering AG. 26 p.

93193040    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 00071472. Mobility of SN66752 in Two Soils after Aging:
            Laboratory I.D. No. R+S 28/79; PA66752 71/6; (W30). Prepared by Schering
            AG. 27 p.

93193041    Chow, N.; Stevens, R. (1990) Nor-Am Chemical Company Phase 3 Summary
            of MRID 00071476 and Related MRIDs 41278114.  Uptake, Metabolic Fate
            and Tissue Residues of Propamocarb in Bluegills and Channel Catfish:
            Chemosphere 10(5): 469-478; (W35) and (W34).  Prepared by University of
            Missouri. 23 p.

93193042    Poggel, H. (1990) Nor-Am Chemical Company Phase 3 Reformat of MRID
            00101641. Propamocarb HCL: Previcur N (CP 604) Embryotoxicity Including
            Teratogenicity Study in Rats after Daily Intragastrical Administration from Day
            6 to Day 19 of Gestation -  Revised Final Report: PF 24/90; Study No. TX
            80.348. Prepared by Schering AG. Ill p.

93193043    Poggel, H. (1990) Nor-Am Chemical Company Phase 3 Reformat of MRID
            00072574. Propamocarb HCL: Previcur N (CP 604) Embryotoxicity Including
            Teratogenicity Study in Rabbits after Daily Intragastrical Administration from
            Day 6 to Day 18 of Gestation - Revised Final Report: T36/2; Study No. TX
            80.122; PF 9/90. Prepared by Schering AG. 69 p.

93193999    Nor-Am Chemical Company (1990) Reregistration Phase 3 Response:
            Propamocarb propyl 3-(dimethylamino)propylcarbamate. Correspondence and
            Supporting Material.
                                       78

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                 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 of
your product(s) containing this active ingredient.  Within 90 days after you receive this Notice
you must respond as set forth in Section in below. Your response must state:

       1.     How you will comply with the requirements set forth in this Notice and its
             Attachments 1  through 6;  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 ni-B);  or

       3.     Why you believe EPA should not require your submission of product specific
             data in the manner specified by this Notice (see section ni-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
                                          79

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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 6).

       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
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 and 2070-0057 (expiration date 03-31-96).

       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 I  -  Why You Are Receiving This Notice
       Section n  -   Data Required By This Notice
       Section in -   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
                    Effects
       Section VI -   Inquiries And Responses To This Notice

The Attachments to  this Notice are:

       1  -   Data  Call-In Chemical Status Sheet
       2  -   Product-Specific Data Call-In Response Form
       3  -   Requirements Status and Registrant's Response Form
       4  -   EPA Batching of End-Use Products for Meeting Acute Toxicology Data
             Requirements for Reregistration
       5  -   List of Registrants Receiving This Notice
       6  -   Cost  Share and Data Compensation Forms
SECTION I.  WHY YOU ARE RECEIVING THIS NOTICE

       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 II.  DATA REQUIRED BY THIS NOTICE

E-A. DATA REQUIRED

       The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form.  Depending on the results of the studies
required in this Notice, additional testing may be required.

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H-B. SCHEDULE FOR SUBMISSION OF DATA

   You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.

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: 703-487-4650).

       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)].

E-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(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-In(s), 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 HI.  COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE

m-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

                                          81.

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       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).

       A discussion of how to 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 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 Data-Call-in
Response Form, and the Requirements  Status and Registrant's Response Form, Attachment 2 and
Attachment 3. The Data Call-In Response Form must be submitted as part of every response to
this Notice.  In addition, one copy of the Requirements Status and Registrant's Response Form
must be submitted for each product listed on the  Data Call-in Response Form 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 Form in Attachment 2). Please note that the company's
authorized representative is required to sign the first page of the Data Call-in Response Form and
Requirements  Status and Registrant's Response Form (if this form is required) and 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 of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-In
Response Form, indicating your election of this option.  Voluntary cancellation is item number 5
on the Data Call-in Response Form. If you choose this  option, this is the only form that you are
required to complete.

       If 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 6 on the
Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-in Response Form. Deletion of a use(s) and the low volume/minor use  option are not valid
options for fulfilling product specific data requirements.

       3. Request for Product Specific Data Waivers.  Waivers for product  specific data are
discussed in Section ni-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. 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

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requirement.

m7C  SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE

       If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number la. or 7b)', then you must select
one of the six options on the Requirements Status and Registrant's Response Form 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 Form.  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
             jointly (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 herein 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 th'e requirements of PR Notice 86-5.

       The time frames in the Requirements Status and Registrant's Response Form 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

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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.

       Option 2, Agreement to Share in Cost to Develop Data — Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
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 will not 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 agreement has been formed. Such
evidence may be your letter offering  to join in an agreement and the other registrant's acceptance
of your offer, or a written 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  to resolve the terms.  Section 3(c)(2)(B) provides that if the parties cannot resolve
the terms  of the agreement they may  resolve their differences through binding arbitration.

       Option 3, Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above.  If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and  continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the data has refused to
accept your offer.  To qualify for this option,  you must submit documentation to the Agency
proving that you have made an offer  to another registrant (who has 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 8570-32, Certification of  Offer to Cost Share 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 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 addition to anything  else, 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) and must not qualify this offer.   The other registrant must also inform EPA
of its election of an option to develop and submit the data required by this Notice by submitting a
Data Call-in Response Form and a Requirements Status and Registrant's Response Form
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 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

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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 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:

              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 apcordance with the
              requirements of the Good Laboratory Practice (GLP)  regulation, 40 CFR Part 160.
              As stated in 40 CFR 160.3(j)  " 'raw data1 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(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 statem'ent 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
               Technical Guidance and that the study has been conducted according to the
               Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
               available from NTIS).  A study not conducted according to the PAG may be
               submitted to the Agency 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

                                              85

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               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 of the PAG
               are met by the study, clearly articulate the rationale why you believe the study
               meets the purpose of the PAG, including copies of any supporting information or
               data.  It has been the Agency's experience that studies completed prior to January
               1970 rarely satisfied the purpose of the PAG and that necessary raw data are
               usually not available for such studies.
        If you submit an existing study, you must certify that the study meets all requirements of
 the criteria outlined above.

      ^  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 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
 upgradeable, you may submit data to upgrade that study.  The Agency will review the data
 submitted 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 will normally be classified as supplemental.   However, it is
 important to note that not  all  studies classified as supplemental are upgradeable.  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 MRID  number(s)  of the study which you are attempting to upgrade and must be in
 conformance with  PR Notice  86-5.

       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

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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 8570-31, Certification with Respect to Data Compensation
Requirements.

       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 and the Requirements
Status and Registrant's Response Form, as.appropriate.

m-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.                                               .                   .

IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE

IV-A NOTICE OF INTENT TO SUSPEND

       The 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   -
FIFRA'section 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:              ........

        1.     Failure to respond as required by this Notice within 90 days of your receipt of this
              Notice.

        2.     Failure to submit on the required schedule an acceptable proposed or final protocol
              when such-is required to be submitted to the Agency for review.
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       3.     Failure to submit on the required schedule an adequate progress report on a study
              as required by this Notice.

       4.     Failure to submit on the required schedule acceptable data as required by this
              Notice.

       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
              information pertaining to submission or citation of existing studies or offers,
              arrangements, or arbitration on the sharing of costs or the formation of Task
              Forces, failure 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).

       6.     Failure to submit supportable  certifications as to the conditions of submitted
              studies, as required by Section ni-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 tendered an offer to share in the cost of
              developing data and provided  proof of the registrant's receipt of such offer or
              failure of a registrant on whom you rely for a generic data exemption either to:

              a.      inform EPA of intent to develop and submit the data required by this Notice
                     on a Data Call-in Response Form and a Requirements Status and
                     Registrant's Response  Form;

              b.      fulfill the commitment to develop and submit the data as required by this
                     Notice; or

              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.

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

                                            88

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      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.

IV-C  EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS

       EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled 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 product(s) 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,
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 cancelled products containing an active ingredient for which the Agency has particular
risk concerns will be determined on case-by-case basis.
                                              89

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       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
 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 will consider granting an
 existing stocks provision.

 SECTION V.  REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
 UNREASONABLE ADVERSE EFFECTS

       Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after  a
 pesticide is registered a registrant has additional factual information regarding unreasonable
 adverse effects on the environment by the 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 to interim or 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.

 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(s)  listed in Attachment 1, the Data Call-In Chemical Status Sheet.
                                           90

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       All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-in Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by this Notice, and should be submitted to the
contact person(s) identified in Attachment 1.  If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-in Response Form need be submitted.

       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,
                   \
                                        Lois Rossi, Division Director
                                        Special Review and
                                          Reregistration Division
 Attachments

       1  -
       2  -
       3  -
       4  -

       5  -
       6  -
Data Call-in Chemical Status Sheet
Product-Specific Data Call-In Response Form
Requirements Status and Registrant's Response Form
EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
List of Registrants Receiving This Notice
Cost Share and  Data Compensation Forms  and the Confidential Statement of
Formula Form
                                             91

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PROPAMOCARB HYDROCHLORIDE DATA CALL-IN CHEMICAL STATUS SHEET

INTRODUCTION

       You have been sent this Product Specific Data Call-in Notice because you have product(s)
containing Propamocarb Hydrochloride.

       This  Product Specific 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
Propamocarb Hydrochloride.  This attachment is to be used in conjunction with (1) the Product
Specific Data Call-In Notice, (2) the Product Specific Data Call-in Response Form (Attachment 2),
(3) the Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for  Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA Acceptance
Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6) and (7) the Cost
Share and Data Compensation Forms in  replying to  this Propamocarb Hydrochloride Product
Specific Data Call-In (Attachment 7).  Instructions and guidance accompany each form.

DATA REQUIRED BY THIS NOTICE

       The  additional data requirements needed  to  complete the  database for Propamocarb
Hydrochloride are contained in the Requirements Status and Registrant's Response, Attachment 3.
The Agency has concluded that additional data On Propamocarb Hydrochloride are  needed for
specific products. These data are required to be submitted to the Agency within the time frame listed.
These data are needed to fully complete the reregistration of all eligible Propamocarb Hydrochloride
products.                                                                '

INQUIRIES AND RESPONSES TO THIS NOTICE


        If you have any questions regarding this product specific data requirements and procedures
established by this Notice, please contact Ed Setren at (703) 308-8166.

        All responses to this Notice for the Product Specific data requirements should be submitted
        to:
              Ed Setren
              Chemical Review Manager Team 81
              Product Reregistration Branch
              Special Review and Reregistration Branch 7508W
              Office of Pesticide Programs
              U.S. Environmental Protection Agency
              Washington, D.C. 20460

              RE: Propamocarb Hydrochloride
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  INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
                             PRODUCT SPECIFIC DATA
Item 1-4.

Item 5.
Item 6.
            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.

Items 8-11.  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.
 Item 7a.
 Item 7b.
                                            95

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        INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
          REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
 Item 1-3
 Item 4.
 Item 5.

 Item 6.
Item 7.
Item 8.
Item 9.
  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, SubpartC.

 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 time 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
 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.  By the specified due date, I will also submit: (1) a completed
 "Certification With Respect To Data Compensation Requirements" form (EPA
 Form 8570-29) 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 in the agreement is
                                          96

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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 Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two completed
and signed copies of the Confidential Statement of Formula (EPA Form 8570-4).

I have made offers to share in the cost to develop data (Offers to Cost Share).  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 Data Call-in Notice that  my product
is similar enough to another product to qualify for this option.  I am submitting
evidence that I have made an offer to another registrant (who has  an obligation to
submit data) to share in the cost of that data.  I am also submitting a completed
"Certification of Offer to Cost Share in the Development Data" form.  I  am
including 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 study is  not  submitted  on time, my product may be subject to
suspension.  I understand that other terms under Option 3 in the Data Call-in Notice
(Section ffl-C. 1.) apply as well.  By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form  8570-29)  and  (2) two  completed and signed copies of  the
Confidential Statement of Formula (EPA Form 8570-4).

By the specified due date, I will submit an existing study that has not been submitted
previously to the Agency by anyone (Submitting an Existing Study).  I certify that
this study will meet all the requirements for submittal of existing data outlined in
Option 4 in the Data Call-In  Notice (Section III-C.l.) and will meet the  attached
acceptance criteria (for acute toxicity and product chemistry data). I will attach the
needed supporting information along with this response.  I also certify that I have
determined that this study will fill the data requirement for which I have indicated this
choice. By the specified due date, I will also submit a completed "Certification With
Respect  To Data Compensation Requirements" form (EPA Form 8570-29) to
show  what data compensation option I have chosen. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
of the Confidential  Statement of Formula (EPA Form 8570-4).

By the specified due date, I will submit or cite data to upgrade a study classified by
the Agency as  partially acceptable and  upgradable  (Upgrading a Study). I will
submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so.  I will provide the MRID or Accession
number of the study  at the due date. I understand that the  conditions for this option
outlined Option 5 in the Data  Call-in  Notice (Section III-C.l.)  apply.  By  the
specified due date, I  will also submit: (1) a completed "Certification With  Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
                              97

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              completed and signed copies of the Confidential Statement of Formula (EPA Form
              8570-4).

       6.      By the specified due date, I will cite an existing study that the Agency has classified
              as acceptable or an existing study that has been submitted but not reviewed by the
              Agency (Citing an Existing Study).  If I am citing another registrant's study, I
              understand that this option is available  only for acute toxicity or certain efficacy data
              and only if the cited study was 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 8570-29) and (2) two
              completed and signed copies of the Confidential Statement of Formula (EPA Form
              8570-4).

       7.      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 in 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 8570-29) and  (2)  two completed and 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.
                                           98

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INSTRUCTIONS  FOR   COMPLETING   THE   "REQUIREMENTS  STATUS  AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA

Item 1-3.     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.                 ?

Item 4.       The guidelines  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,  Subpartc.       •

Item 5.       The study title associated with, the guideline reference number is identified.

Item 6.       The use patters (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.

Item?.       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.           :

Item 8.   •    The due date for submission of each  study is identified. It is normally based  on  8
             months  after issuance of the Reregistration  Eligibility Documents  unless  EPA
             determines that a longer time period is necessary.     ,

Item 9.       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.

              1.     I will generate and submit data by the specified due date (Developing Data).
             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.

              2.     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 on 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 in the  agreement  is
              committing  to submit or provide the required data;  if the required study is not
              submitted on time, my product my be subject to suspension.
                                            99

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 3.     I have made offers to share in the cost to develop data (Offers to Cost Share).
 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 Data Call-in Notice that my product
 is similar enough to another product to qualify for  this option.  I am submitting
 evidence that I have made an offer to another registrant (who has an obligation to
 submit data) to share in the cost of that data.  I am also submitting a completed "
 Certification of offer to Cost Share in the Development Data" form.  I am including
 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 require data; if the
 required study is  not submitted on time, my product may be subject to suspension.
 I understand that other terms under Option 3 in the Data Call-In Notice (Section III-
 C.l.) apply as well.

 4.     By the specified due date, I  will submit an existing study that has not been
 submitted previously to the Agency by anyone (submitting an Existing Study).  I
 certify that this study will meet all  the requirements  for submittal of existing data
 outlined in option 4 in the Data Call-In Notice (Section ni-C.l.) and will meet the
 attached acceptance criteria (for acute toxicity and product chemistry data).  I will
 attach the needed supporting information along with this response.  I also certify that
 I have determined that this study will fill the data requirement for which I  have
 indicated this  choice.

 5.      By the specified due date,  I will submit or  cite data to  upgrade a study
 classified by the Agency as partially acceptable and upgrade (upgrading a study).  I
 will submit evidence of the  Agency's  review indicating that the  study  may. be
 upgraded and what information is required to do so.   I will provide the MRID or
 Accession  number of the study at the due date. I understand that the conditions for
 this Option outlined Option 5 in the Data Call-in  Notice (Section III-C.l.) apply.

 6.     By  the specified due date, I will  cite -an existing study that the Agency has
 classified as acceptable or an existing  study that has been submitted but not reviewed
 by the Agency (Citing an Existing Study). If I am citing another registrant's study,
 I understand that this option is available only for acute toxicity or certain efficacy data
 and only if the cited study was 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) number (s) for
 the cited data on a "Product Specific  Data Report" form or in a similar format. If I
 cite another registratrant's data, I will submit a completed "Certification With Respect
 To Data Compensation  Requirements" form.

 7.     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

                               100

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             or provide information in support of my request.  If the Ageney approves my waiver
             request, I will not be require to supply the data pursuant to Section 3(c) (2) (B) of
             FEFRA.  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 chosen.   I  also understand that the deadline for
             submission  of data as specified by the original data cal-in notice will not change.

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 cancelled this product. For
these cases, please supply all relevant details so that EPA can ensure that its records are correct.
                                            101

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No toxicology batching is required.
                         102

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Instructions for Completing the Confidential Statement of Formula

The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required.  Following are basic instructions:

      a. All the blocks on the form must be filled in and answered completely.

      b.     If any block is not applicable, mark it N/A.
       c.


       d.


       e.


       f.

       g-


       h.


       i.

       j-



       k.

       1.


       m.



       n.
The CSF must be signed, dated and the telephone number of the responsible party
must be provided.

All applicable information which is on the product specific data submission must also
be reported on the CSF.

All weights reported under item 7 must be in pounds per gallon for liquids and pounds
per cubic feet for solids.

Flashpoint must be in degrees Fahrenheit and flame extension in inches.

For all active ingredients, the EPA Registration Numbers for the currently registered
source products must be reported under column 12.

The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and  ail
common names for the trade names must be reported.

For the active ingredients, the percent purity of the source products must be reported
under column 10 and must be exactly the same as on the source product's label.
All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams.
In no case will volumes be  accepted. Do not mix English and metric system  units
(i.e., pounds  and kilograms).

All the items  under column 13.b. must  total 100 percent.

All items under columns 14.a.  and 14.b. for the active ingredients must represent
pure active form.

The upper and lower certified limits for ail active and inert ingredients must follow
the 40 CFR 158.175 instructions. An explanation must be provided if the proposed
limits are different than standard certified limits.

When new CSFs are submitted and approved, all previously submitted CSFs become
obsolete for that specific formulation.
                                          104

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                           United  States Environmental  Protection  Agency
                                        Washington,  DC  20460
                              CERTIFICATION OF OFFER  TO  COST
                           SHARE IN THE DEVELOPMENT OF  DATA
 Form Approved

 OMB No. 2070-0106
          2070-0057
 Approval  Expires 3-31-96
 Public reporting burden for this collection of information is estimated to average 15 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 suggestions for reducing this burden, to Chief. Information Policy
 Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
 of Management and Budget, Paperwork Reduction Project (2070-0106), Washington,  DC 20503.

 Please fill In blanks below.
  Company Name •
Company Number
  Product Name
                                                                               EPA Reg. No.
 I Certify that:

 My company is willing to develop and submit the data required by EPA under the authority of the Federal
 Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
 enter into ah agreement with one or more registrants to develop jointly or share in the cost of developing
 data.

 My firm has offered in writing to enter into such an agreement.  That offer was irrevocable and included an
 offer to be bound  by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
 terms could not be reached otherwise.  This offer was made to  the following firm(s) on the  following
 date(s):
  Nam a of Flrm(s)
 Date of Offer
Certification:
I certify that I am duly authorized to represent the company.named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
 EPA Form 8570-32 (5/91)    Replaces EPA Form 8580, which is obsolete

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