United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA738-R-00-017
September 2000
 Reregistration Eligibility
 Decision (RED)
 Diclofop-Methyl

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                  United States
                  Environmental Protection
                  Agency
                       Prevention, Pesticides
                       And Toxic Substances
                       (7508C)	
EPA-738-F-00-007
September, 2000
                  R.E.D.   FACTS
      Pesticide
Reregistration
Diclofop-Methyl
     All pesticides sold or distributed in the United States must be registered by
EPA, based on scientific studies showing that they can be used without posing
unreasonable risks to people or the environment.  Because of advances in scientific
knowledge, the law requires that pesticides which were first registered before
November 1,1984, be reregistered to ensure that they meet today's more stringent
standards.
     In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers,  describing the human health and
environmental effects of each pesticide. To implement provisions of the Food
Quality Protection Act of 1996, EPA considers the special sensitivity of infants and
children to pesticides, as well as aggregate exposure of the public to pesticide
residues from all sources, and the cumulative effects of pesticides and other
compounds with common mechanisms of toxicity. The Agency develops any
mitigation measures or regulatory controls needed to effectively reduce each
pesticide's risks. EPA then reregisters pesticides that meet the safety standard of
the FQPA and can be used without posing unreasonable risks to human health or
the environment
     When a pesticide is eligible for reregistration, EPA explains the basis for its
decision in a Reregistration Eligibility Decision (RED) document This fact sheet
summarizes the information in the RED document for reregistration case 2160,
Diclofop-Methyl.
     Use Profile       Diclofop-methyl is a restricted use herbicide used on wheat, barley, and golf
                  courses (turf). Diclofop-methyl controls or suppresses various grass weed species.
                  The total annual domestic usage of diclofop-methyl is approximately 750,000
                  pounds of active ingredient (ai.).

     Regulatory       Diclofop-methyl was first registered in the United States in 1982 for the
         History  control or suppression of wild oats and annual grasses in wheat and barley. It is
                  currently also registered for goose grass control on established golf courses.  The
                  use of diclofop-methyl on golf courses is authorized under Section 24(c) of FIFRA
                  in 11 states.

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Human Health
    Assessment
Toxicity
      Toxicity Categories, which range from 1 (most toxic) to 4 (least toxic),
placed diclofop-methyl in toxicity category II for the oral route of exposure, III by
the dermal route, and IV via the inhalation route. In primary irritation studies,
diclofop-methyl produced moderate eye irritation (toxicity category III) and slight
dermal irritation (toxicity category IV).
      Diclofop-methyl is classified as a likely human carcinogen based on
laboratory studies in the rat and the mouse. The Agency used a linear low-dose
approach (Q*) to assess cancer risk to diclofop-methyl.
                    Dietary Exposure (food and water)
                          EPA's human health risk assessment for diclofop-methyl indicates few risk
                    concerns. Food risks, as measured by both an acute and chronic Population
                    Adjusted Doses (PAD), are well below the Agency's level of concern. When
                    considering the carcinogenic potential of diclofop-methyl, the dietary (food) risk
                    appears to be slightly above the level of concern
                    (1.2x 10"6). Even though this cancer risk is slightly over the level of concern (10~6),
                    the Agency believes this overestimates the actual carcinogenic exposure to
                    diclofop-methyl in the food supply. Drinking water risk estimates are based on
                    surface and groundwater screening models. Limited monitoring data and a small
                    scale prospective ground water (PGW) study also support the conclusion that
                    diclofop-methyl is not likely to be found in drinking water  Drinking water risks are,
                    therefore, not of concern to the Agency.
                    Non-Occupational Risks (Golfers)
                          The only non-occupational source of exposure to diclofop-methyl is residues
                    on treated golf courses. Cancer risk for golfers is 2.2 x 10"6. The Agency believes
                    that the cancer risks associated with golfers on diclofop-methyl treated turf is an
                    upper-bound estimate since the post-application risk assessment is based on
                    protective assumptions related to golfer behavior and diclofop-methyl use practices.
                    The risk is overestimated because the Agency assumes the golfer is exposed
                    continuously during a round of golf (four hours, assuming the entire course is
                    treated), two days per year, for 50 years. But because diclofop-methyl is usually
                    applied as a spot treatment covering less than the entire course, the golfer would be
                    exposed for a much shorter duration.  A more likely duration of exposure is
                    probably 1A hour rather than four hours.  With Vz hour of exposure, the resulting
                    cancer risk would be 2.7x10'7 and would not be of concern to the Agency.  The
                    odds of a golfer encountering diclofop-methyl treatment twice a year for a lifetime is
                    also unlikely. The Agency is therefore not concerned with cancer risks to golfers
                    exposed to residues of diclofop-methyl on treated turf.

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Aggregate Risk
      Under the Food Quality Protection Act, the Agency considers contributions
to risk from various exposure sources, specifically food, drinking water, and non-
occupational sources (e.g., golfers playing on treated courses).  Four aggregate risk
assessments were calculated for diclofop-methyl.
      The short-and intermediate term as well as the chronic (non-cancer)
aggregate are not of concern to the Agency  Although the cancer aggregate risk
appears to be of concern, the Agency does not believe that exposure to residues of
diclofop-methyl in food and drinking water contribute to an aggregate risk of
concern for the general population.  The food cancer risk is based on a number of
protective exposure assumptions and the water cancer risk is based on screening
level modeling estimates.
      Golfers who play on diclofop-methyl treated courses may be at a greater
aggregate cancer risk because the carcinogenic risk to golfers is
2.2 x 10"6.  Any aggregation of carcinogenic exposure to golfers with carcinogenic
exposure from food and drinking water would ordinarily increase the risk further
above the level of concern. In this case, golfer exposure to diclofop-methyl is
probably much less than the assessment indicates. Because the cancer risk estimate
to golfers is based on high-end assumptions and may possibly overestimate risk,
aggregation with food and drinking water estimates does not result in a meaningful
estimate of aggregate carcinogenic risk. Overall, the Agency concludes that there is
neither an aggregate carcinogenic concern for the general population nor for golfers
who play on diclofop-methyl treated courses.
Tolerances
      Tolerances (refer to 40#CFR §180.385) or maximum residue limits are
summarized below.
•     Revoke 2 tolerances for lentils and dry peas.  The registrant no longer
      supports these commodities.
•     Establish 23 tolerances for the following: Barley hay, wheat forage, and
      wheat hay.  Tolerances will also be established for Ihe following: cattle fat,
      cattle meat, cattle meat byproducts (excluding kidney), cattle kidney, goat
      fat, goat meat, goat meat byproducts (excluding kidney), goat kidney, hog
      fat, hog meat byproducts (excluding kidney), hog kidney, horse fat, horse
      meat, horse meat byproducts (excluding kidney), horse kidney, milk, sheep
      fat, sheep meat, sheep meat byproducts (excluding kidney), and sheep
      kidney.

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                     Occupational and Residential Exposure
                           The most significant human risk concern relates to handlers who mix, load,
                     and apply diclofop-methyl to agricultural sites. Non-cancer risks do not exceed the
                     Agency's level of concern. However, cancer risks associated with the use of
                     diclofop-methyl are of concern to Hie Agency Cancer risk for handlers
                     incorporating both dermal and inhalation exposure range from 1.4x10"2 to 5.1x10'6
                     without the use of personal protective equipment, 8.4x10'5 to 6.0x10'7 with PPE,
                     and 5.8x10'5 to 1.4x10'6 at tiie engineering controls level. The Agency's goal is to
                     reduce worker cancer risks to 10~6 or less, although risks somewhat higher than 10"
                     6 may be considered acceptable if measures to mitigate these risks are not available
                     and benefits of continuing use are demonstrated. Thus, for risks that are greater
                     than 10~6 and less than 10"4, the Agency carefully examines risks in this range
                     including the benefits of use, availability of alternatives, number of workers at risk,
                     and will seek ways to further mitigate these risks. Because all of the worker
                     scenarios described in Section III have cancer risk estimates in the range of 10"6 to
                     10"4, the Agency considered whether additional worker mitigation measures were
                     available.

                     FQPA Considerations
                           The FQPA Safety  Factor is intended to provide up to an additional 10-fold
                     safety factor (10X), to protect for special sensitivity in infants and children to
                     specific pesticide residues in food or to compensate for an incomplete database.
                     The Agency reduced the FQPA Safety Factor to IX after evaluating the hazard
                     and exposure data for diclofop-methyl. The FQPA Safety Factor was reduced to
                     IX for the following reasons:
                     1.     The toxicology database is complete for the assessment of the effects
                           following in utero and/or postnatal exposure to diclofop-methyl;
                     2.     There is no indication of quantitative or qualitative increased susceptibility of
                           rats or rabbits to in utero and/or postnatal exposure to diclofop-methyl in the
                           available toxicity data;
                     3.     The Agency determined that a developmental neurotoxicity study is not
                           required  for diclofop-methyl; and
                     4.     Adequate monitoring.data, surrogate data, and/or modeling outputs are
                           available to satisfactorily assess dietary  and non-occupational sources of
                           exposure and to provide a screening level drinking water exposure
                           assessment. The assumptions and models used in the assessments do not
                           underestimate the potential risk for infants and children.

Environmental   Environmental Fate
    Assessm ent         Diclofop-methyl is not persistent in soil under aerobic conditions and has
                     very low persistence in anaerobic soil or water. The residues that do reach surface

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                        waters will likely be rapidly degraded by microbial metabolism. To better
                        understand the environmental fate and transport of diclofop-methyl and its free acid
                        metabolite in soil, soil water, and groundwater, a small scale prospective
                        groundwater (PGW) study was undertaken by the registrant The results of the
                        PGW study indicated that neither diclofop-methyl or its acid degradate migrated to
                        the ground water during the two- plus- year study in a worst case scenario
                        application. When considering the existing environmental fate data, the Agency
                        concludes that diclofop-methyl is unlikely to reach surface and ground water
   Risk Mitigation
   Additional Data
           Required
Ecological Effects
      The Agency has identified certain ecological risks of potential concern.
Although there are remaining uncertainties, diclofop-methyl poses a risk of
reproductive toxicity to mammals on an acute basis and may also pose a chronic
risk to mammals.  Runoff and spray drift from diclofop-melhyl pose a high risk to
nontarget grasses and sedges. Toxicity data are lacking for risks to aquatic plant
species and the Agency is requiring further studies to better characterize these risks.
Revised label' language on reducing spray drift will help to reduce exposure to non-
target organisms.

      The Agency found that exposure to wheat and barley handlers could be
substantially reduced by employing appropriate engineering controls, such as closed
mixing/loading systems and enclosed application equipment To minimize the
occupational cancer risk to such handlers, the registrant has agreed to implement
engineering controls to reduce exposure to all agricultural handlers.

      In addition to certain chemistry data requirements, EPA is requiring the
following additional generic studies for diclofop-methyl to confirm its regulatory
assessments and conclusions:
      Dermal Exposure (§ 875.2400)
•     Foliar Dislodgeable Residue Dissipation (§ 875.2100)
      Bioaccumulation Study in Fish (§ 850.1730)
      Aquatic Plant Toxicity (§ 850.4400 and 850.5400)
      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 diclofop-methyl end-use products must comply with EPA's current
Changes Req uired   pesticide product labeling requirements and with the specifications outlined in the
                         RED. For a comprehensive list of labeling requirements, please see Table 11 the
                         diclofop-methyl RED document.

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 Regulatory
 Conclusion
  For More
Information
      The Agency finds that the currently registered uses of diclofop-methyl are
eligible for reregistration, provided engineering controls for both aerial and
groundboom handlers are required for diclofop-methyl containing products and
reflected in product labeling,

      The use of currently registered products containing diclofop-methyl in
accordance with approved labeling will not pose unreasonable risks or adverse
effects to humans or the environment. Therefore, all uses of these products are
eligible for reregistration.
      Diclofop-methyl products will be reregistered once the required product-
specific data, revised Confidential Statements of Formula, and revised labeling are
received and accepted by EPA.

      EPA is requesting public comments on Hie Reregistration Eligibility Decision
(RED) document for diclofop-methyl during a 60-day time period, as announced in
a Notice of Availability published in the Federal Register.  To obtain a copy of the
RED document or to submit written comments, please contact the Pesticide
Docket, Public Information and Records Integrity Branch, Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP), US EPA,
Washington, DC 20460, telephone 703-305-5805.
      Electronic copies of the RED and this fact sheet are available on the Internet
See http://www.epa.gov/REDs.
      Printed copies of the RED and fact sheet can be obtained from EPA's
National Service Center for Environmental Publications (EPA/NSCEP), PO Box
42419, Cincinnati, OH 45242-2419, telephone 1-800-490-9198; fax 513-489-
8695.
      Following the comment period, the diclofop-methyl RED document also will
be available from the National Technical Information Service (NTIS), 5285 Port
Royal Road, Springfield, VA 22161, telephone 1-800-553-6847, or 703-605-
6000.
      For more information about EPA's pesticide reregistration program, the
diclofop-methyl RED, or reregistration of individual products containing diclofop-
methyl, please contact the Special Review and Reregistration Division (7508C),
OPP, US EPA, Washington, DC 20460, telephone 703-308-8000.
      For information about the health effects of pesticides, or for assistance in
recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticide Telecommunications Network (NPTN). Call toll-free 1-800-
858-7378, from 6:30 am to 4:30 pm Pacific Time, or 9:30 am to 7:30 pm Eastern
Standard Time, seven days a week. Their internet address is
ace.orst.edu/info/nptn.

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          \
                       UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                                     WASHINGTON, D.C.  20460
CERTIFIED MAIL
Dear Registrant:
OCT24
                                                                           OFFICE OF
                                                                      PREVENTION, PESTICIDES
                                                                      AND TOXIC SUBSTANCES
                                                                   September 29,2000
     This is to inform you that the Environmental Protection Agency (hereafter referred to as
EPA or the Agency) has completed its review of the available data and comments received
related to the preliminary and revised risk assessments for the herbicide diclofop-methyl. Based
on comments received during the registrant error correction period, the Agency revised the
human health and environmental effects risk assessments and made them available to the public
on August 28,2000. During this comment phase, all interested parties were invited to participate
and provide comments and suggestions on ways the Agency might mitigate the estimated risks
presented in the revised risk assessments. The Agency is now publishing its reregistration
eligibility, risk management, and tolerance reassessment decision for the current uses of
diclofop-methyl and its associated human health and environmental risks.

     Based on its review, EPA has identified risk mitigation measures that the Agency believes
are necessary to address the human health and environmental risks associated with the current
use of diclofop-methyl. The EPA is now publishing its decision on the reregistration eligibility
of and risk management decision for the current uses of diclofop-methyl and its associated
human health and environmental risks. The Agency's decision on the chemical diclofop-methyl
can be found in the attached document entitled, "Reregistration Eligibility Decision for Diclofop-
Methyl" which was approved on September 29,2000.

     A Notice of Availability for this Reregistration Eligibility Decision for  diclofop-methyl is
being published in the Federal Register. To obtain a copy of the RED document, please contact
the OPP Public Regulatory Docket (7502C), US EPA, Ariel Rios Building, 1200 Pennsylvania
Avenue NW, Washington, DC 20460, telephone (703) 305-5805. Electronic copies of the RED
and all supporting documents are available on the website:
http:www.epa.gov/pesticides/reregistration/diclofop-methyl.

     The RED is based on the updated technical information found in the diclofop-methyl public
docket. The docket not only includes  background information and comments on the Agency's
preliminary risk assessments, it also now includes the Agency's revised risk assessments for
diclofop-methyl (revised as of August 10,2000), and documents summarizing the Agency's
Response to Comments. The Response to Comments documents address corrections to the

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 preliminary risk assessments submitted by chemical registrants.

      This document and the process used to develop it are the result of a pilot process to
 facilitate greater public involvement and participation in the reregistration and/or tolerance
 reassessment decisions on pesticides. As part of the Agency's effort to involve the public in the
 implementation of the Food Quality Protection Act of 1996 (FQPA), the Agency is undertaking a
 special effort to maintain open public dockets on pesticides and to engage the public in the
 reregistration and tolerance reassessment processes for these chemicals. This open process
 follows the guidance developed by the Tolerance Reassessment Advisory Committee (TRAC), a
 large multi-stakeholder advisory body that advised the Agency on implementing the new
 provisions of the FQPA.

      This document contains a generic and/or a product-specific Data Call-In(s) (DCI) that
 outline(s) further data requirements for this chemical. Note that registrants of diclofop-methyl
 must respond to DCIs issued by the Agency within 90 days of receipt of this letter.

      In this RED, the Agency has determined that diclofop-methyl will be eligible for
 reregistration provided that all the conditions identified in this document are satisfied, including
 implementation of the risk mitigation measures outlined in Section IV of the document.  The
 Agency believes that current uses of diclofop-methyl may pose unreasonable adverse effects to
 human health and the environment, and that such effects can be mitigated with the risk
 mitigation measures identified in this RED. Accordingly, the  Agency recommends that
 registrants implement these risk mitigation measures immediately. Section IV of this RED
 describes labeling amendments for end-use products and data requirements necessary to
 implement these mitigation measures. Instructions for registrants on submitting revised labeling
 and the time frame established to do so can be found in Section V of this document.

     Should a registrant fail to implement any of the risk mitigation measures outlined in this
 document, the Agency will continue to have concerns about the risks posed by diclofop-methyl.
 Where the Agency has identified any unreasonable adverse effect to human health and the
 environment, the Agency may at any time initiate appropriate regulatory action to address this
 concern. At that time, any affected person(s) may challenge the Agency's action.

     If you have questions on this document or the label changes necessary for reregistration,
 please contact the Chemical  Review Manager, Anne Overstreet at (703)308-8068.  For questions
 about product reregistration and/or the Product DCI that accompanies this document, please
 contact Veronica Dutch at*(703) 308-8585.
Attachment
                                         ois A. Rossi, Director
                                        Special Review and
                                         Reregistration Division

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Reregistration Eligibility Decision
               for
        Diclofop-Methyl
         Case No. 2160

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                        TABLE OF CONTENTS
Diclofop Methyl Team	i

Glossary of Terms and Abbreviations  	 iii

Executive Summary  	1

I.    Introduction	7

II.   Chemical Overview	9

     A.   Regulatory History 	9
     B.   Chemical Identification	9
     C.   Estimated Usage of Pesticide	11

IDE.  Summary of Diclofop-Methyl Risk Assessment	12

     A.   Human Health Risk Assessment 	12
          1.    Dietary Risk from Food 	12
                a.   Toxicity	12
                b.   FQPA Safety Factor	12
                c.   Population Adjusted Dose (PAD)	13
                d.   Summary of Toxicological Endpoints  	13
                e.   Exposure Assumptions  	15
                    i.    Residue Estimates for Acute Dietary (food) Risk: 	16
                    ii.    Residue Estimates for Chronic and Carcinogenic
                          Dietary (Food) Risks: 	18
          2.    Food Risk Characterization 	19
                a.   Acute Dietary (food) Risk: 	19
                b.   Chronic Dietary (food) Risk:	20
                c.   Carcinogenic Dietary (food) Risk	20
          3.    Dietary Risk from Drinking Water	20
                a.   Surface Water	21
                b.   Ground Water	22
                c.   Drinking Water Levels of Comparison (DWLOC's)	22
                    i.    DWLOC's for Acute Exposure	22
                    ii.    DWLOC's for Short-Term Exposure	23
                    iii.   DWLOC's for Chronic Exposure  	23
                    iv.   DWLOC's for Cancer 	24

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           4.    Residential Handler and Non-Occupational Risk	24
                a.   Residential Handler Risk	...24
                b.   Non-Occupational Post-Application Risk	24
                     i.     Non-Cancer Risk	25
                     ii.    Cancer Risk	25
           5.    Aggregate Risk	26
                a.   Acute Aggregate Risk	26
                b.   Short-Term Aggregate Risk	26
                c.   Chronic (Non-Cancer) Aggregate Risk	27
                d.   Cancer Aggregate Risk	27
           4.    Occupational Risk	28
                a.   Toxicity	28
                b.   Occupational Risk Assessment Exposure 	29
                     i.    Occupational Handler Risks	.29
                     ii.    Non-Cancer Handler Risk	32
                     iii.   Cancer Handler Risk	32
           5.    Occupational Post-Application	34
                a.   Occupational Non-Cancer Post-Application Risk	34
                b.   Occupational Cancer Post-Application Risk	35
     D.    Environmental Risk Assessment	35
           1.    Environmental Fate and Transport	36
           2.    Risk to Bird and Mammal Species	37
                a.   Acute Risk To Birds  	37
                b.   Chronic Risks To Birds	37
                c.    Acute Risks to Mammals	3g
                d.   Chronic Risks To Mammals	38
           3.    Risk to Aquatic Animal Species	39
           4.    Risk To Terrestrial and Aquatic Plant Species	39
                a.    Acute and Chronic Risks Non-target Terrestrial Plants	39
                b.    Acute and Chronic Risks to Aquatic Plants	40

IV.  Risk Management, Reregistration and Tolerance Reassessment Decision	40

     A.    Determination of Reregistration Eligibility	40
     B.    Summary of Comments and Responses	41
     C.    Tolerance Reassessment 	   42
     D.    Regulatory Position	42
           1.    FQPA Assessment	42
                a.    "Risk Cup" Determination	42
                b.    Enforcement Method	42

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          2.    Tolerance Summary	42
               a.    Tolerances To Be Listed Under 40 CFR §180.385(a)(l)	43
               b.    Tolerances Needed Under 40 CFR §180.385(a)(l)	43
               c.    Tolerances Needed Under 40 CFR §180.385(a)(2)	43
          3.    Endocrine Disrupter Effects	45
     E.    Human Health Risk Mitigation 	46
          1.    Dietary Mitigation	46
               a.    Acute Dietary (Food)	46
               b.    Chronic Dietary (Food) 	47
               c.    Carcinogenic Dietary (Food)	47
               d.    Drinking Water	.48
                    i.    DWLOC's for Acute Risks	48
                    ii.    DWLOC's for Chronic Risks  	49
                    in.   DWLOC's for Cancer Risks	49
          2.    Non-Occupational Risk Mitigation	49
               a.    Non-Occupational Non-Cancer Risk Mitigation	49
               b.    Non-Occupational Cancer Risk Mitigation	49
          3.    Aggregate Risk Mitigation	50
               a.    Acute Aggregate Risk Mitigation	50
               b.    Short-Term Aggregate Risk Mitigation	50
               c.    Chronic (Non-Cancer) Aggregate Risk Mitigation	50
               d.    Chronic (Cancer) Aggregate Risk Mitigation	50
          4.    Occupational Risk Mitigation	51
               a.    Agricultural Handler Risk Mitigation	51
                    i.    Handler Non-Cancer Risk Mitigation 	51
                    ii.    Handler Cancer Risk Mitigation	51
               b.    Post-Application Worker Risk Mitigation	52
                    i.    Workers Who Mow and Maintain Golf Courses	52
                    ii.    Workers Who Scout Wheat and Barley Fields	52
          5.    Environmental Risk Mitigation	53
     F.    Other Labeling Modifications	53
          1.    Endangered Species Statement  	54
          2.    Spray Drift Management 	54

V.   What Registrants Need To Do	55

     A.   Manufacturing Use Products  	55
          1.    Additional Generic Data Requirements	55
          2.    Labeling for Manufacturing Use Products	55
     B.   End-Use Products 	56
          1.    Additional Generic Data Requirements	56
          2.    Labeling for End-Use Products	56
     C.   Existing Stocks	56

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     D.    Labeling Changes Summary Table	57

VI.  Related Documents and How to Access Them	67

VII.  Appendices	59

     A:   Use Patterns Eligible For Reregistration	71
     B.   Table Of Generic Data Requirements And Studies Used To
          Make The Reregistration Eligibility Decision	73
     C:   Technical Support Documents  	81
     D.   Citations Considered To Be Part Of The Database Supporting the Interim
          Reregistration Eligibility Decision (Bibliography)	83
     E:   Generic Data Call-In	97
     F:   Product Specific Data Call-In	99
     G:   List of Registrants Sent this Data Call-in	101
     H:   List of Available Related Documents and Electronically Available Forms	103

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Diclofop Methyl Team

Office of Pesticide Programs:

Health Effects Risk Assessment

Christina Jarvis
Bob Fricke
Al Nielsen
Seyed Tadayon
Sheila Piper
Richard Griffin

Environmental Fate Risk Assessment

Subijoy Dutta
Nicholas Mastrota

Use and Usage Analysis

Arnold Aspelin
Virginia Dietrich
Alan Halvorson

Registration Support

Eugene Wilson

Risk Management
Anne Overstreet
Michael McDavit

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Glossary of Terms and Abbreviations

AE          Acid Equivalent
a.i.           Active Ingredient
AGDCI      Agricultural Data Call-In
ai           Active Ingredient
aPAD        Acute Population Adjusted Dose
AR          Anticipated Residue
ARC         Anticipated Residue Contribution
BCF         Bioconcentration Factor
CAS         Chemical Abstracts Service
CI           Cation
CNS         Central Nervous System
cPAD        Chronic Population Adjusted Dose
CSF         Confidential Statement of Formula
CFR         Code of Federal Regulations
CSFII        USDA Continuing Surveys for Food Intake by Individuals
DCI         Data Call-In
DEEM       Dietary Exposure Evaluation Model
DFR         Dislodgeable Foliar Residue
DRES        Dietary Risk Evaluation System
DWEL       Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific
             (i.e., drinking water) lifetime exposure at which adverse, noncarcinogenic health effects
             are not anticipated to occur.
DWLOC     Drinking Water Level of Comparison..
EC          Emulsifiable Concentrate Formulation
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
FAO         Food and Agriculture Organization
FDA         Food and Drug Administration
FIFRA       Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA     Federal Food, Drug, and Cosmetic Act
FQPA       Food Quality Protection Act
FOB         Functional Observation Battery
G           Granular Formulation
GENEEC    Tier I Surface Water Computer Model
GLC         Gas Liquid Chromatography
GLN         Guideline Number
GM         Geometric Mean
GRAS       Generally Recognized as Safe as Designated by FDA

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 Glossary of Terms and Abbreviations

 HA         Health Advisory (HA). The HA values are used as informal guidance to municipalities
             and other organizations when emergency spills or contamination situations occur.
 HAFT       Highest Average Field Trial
 HOT        Highest Dose Tested
 IR          Index Reservoir
 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.
 LDSO        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.
 LEL         Lowest Effect Level
 LOG        Level of Concern
 LOD        Limit of Detection
 LOAEL      Lowest Observed Adverse 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.
 mg/kg/day    Milligram Per Kilogram Per Day
 mg/L        Milligrams Per Liter
 MOE        Margin of Exposure
 MP         Manufecturing-Use Product
 MPI         Maximum Permissible Intake
 MRID       Master Record Identification (number). EPA's system of recording and tracking
             studies submitted.
NA         Not Applicable
N/A         Not Applicable
NAWQA    USGS National Water Quality Assessment
NOEC       No Observable Effect Concentration
NOEL       No Observed Effect Level
NOAEL      No Observed Adverse Effect Level
NPDES      National Pollutant Discharge Elimination System
NR         Not Required
 OP          Organophosphate
 OPP         EPA Office of Pesticide Programs
 OPPTS       EPA Office of Prevention, Pesticides and Toxic Substances
                                          rv

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Glossary of Terms and Abbreviations
 Pa

PAD
PADI
PAG
PAM
PCA
PDP
PHED
Pffl
ppb
PPE
ppm
PRN
PRZM/
EXAMS
Qi*

RAC
RBC
RED
REI
RiD
RQ
RS
RUP
SAP
SCI-GROW
SF
SLC
SLN
STORET
TC
TD
TEP
TGAI
TLC
TMRC
pascal, the pressure exerted by a force of one newton acting on an area of one square
meter.
Population Adjusted Dose
Provisional Acceptable Daily Intake
Pesticide Assessment Guideline
Pesticide Analytical Method
Percent Crop Area
USDA Pesticide Data Program
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Pesticide Registration Notice

Tier II Surface Wate'r Computer Model
The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
Raw Agriculture Commodity
Red Blood Cell
Reregistration Eligibility Decision
Restricted Entry Interval
Reference Dose
Risk Quotient
Registration Standard
Restricted Use Pesticide
Science Advisory Panel
Tier I Ground Water Computer Model
Safety Factor
Single Layer Clothing
Special Local Need (Registrations Under Section 24(c) of FIFRA)
STOrage and RETrieval (USER A repository of water quality data)
Toxic Concentration. The concentration at which a substance produces a toxic effect.
Toxic Dose. The dose at which a substance produces a toxic effect.
Typical End-Use Product
Technical Grade Active Ingredient
Thin Layer Chromatography
Theoretical Maximum Residue Contribution

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Glossary of Terms and Abbreviations

torr          A unit of pressure needed to support a column of mercury 1 mm high under standard
             conditions.
TRR         Total Radioactive Residue
UF          Uncertainty Factor
/ig/g         Mcrograms Per Gram
H g/L         Micrograms Per Liter
USDA       United States Department of Agriculture
USGS        United States Geological Survey
UV          Ultraviolet
WHO        World Health Organization
WP          Wettable Powder
WPS         Worker Protection Standard
                                          VI

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Executive Summary

       EPA has completed its review of public comments on the revised risk assessments and is
issuing its risk management decisions for diclofop-methyl. This document also presents the Agency's
tolerance reassessment for diclofop-methyl, which includes the consideration of risk to infants and
children for any potential dietary, drinking water, dermal, inhalation, or oral exposures. The Agency
made its reregistration eligibility determination and tolerance reassessment decisions based on the data
required for reregistration, the current guidelines for conducting acceptable studies to generate such
data, and published scientific literature. The Agency has found that currently registered uses of
diclofop-methyl are eligible for reregistration, provided specific changes are made to the label.

       The revised risk assessments are based on review of the required target database supporting
the use patterns of currently registered products. To strengthen stakeholder involvement and help
ensure decisions made under Food Quality Protection Act (FQPA) are transparent and based on the
best available information, the Agency opened a public docket during the development of this
Reregistration Eligibility Decision (RED) and invited stakeholders to provide comments on the
Agency's risk assessments before issuing its risk mitigation decision on diclofop-methyl. After
considering the revised risks and comments from Aventis Crop Science, the technical registrant of
diclofop-methyl,  EPA developed its risk management decision for uses of diclofop-methyl that pose
risks of concern.  This decision is discussed fully in this document In this document, existing tolerances
have been reassessed and new tolerances established for the combined residues of diclofop-methyl and
diclofop-acid (free and conjugated), determined as diclofop-methyl, in milk and livestock (cattle, goats,
horses, and sheep) commodities.

       Diclofop-methyl is a restricted use herbicide used on wheat, barley, and golf courses (turf).
Diclofop-methyl, first registered in 1982, controls or suppresses various grass weed species. The total
annual domestic usage of diclofop-methyl is approximately 750,000 pounds of active ingredient (a,i.).

Overall Risk Summary

       EPA's human health risk assessment for diclofop-methyl indicates  few risk concerns. Food
risks, as measured by both an acute and chronic Population Adjusted Doses (PAD), are well below the
Agency's level of concern.  However, when considering the carcinogenic potential of diclofop-methyl,
the dietary (food) risk appears to be over the level of concern (1.2 x 10"6).  Even though the dietary
(food) cancer risk is slightly over the level of concern (10~6), the Agency believes this may be an
overestimate of actual carcinogenic exposure to diclofop-methyl in the food supply. Drinking water risk
estimates based on surface and goundwater screening models (after considering limited monitoring data
and a small scale prospective ground water (PGW) study) are less than the  level of concern for all
populations.

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       The Agency estimates that golfers who regularly play on treated courses over a lifetime may
face a cancer risk of concern (2.2 x 10"6). Furthermore, when golfer exposure is aggregated with
dietary exposure, a higher cancer risk for such golfers would result These risk estimates, however, are
believed to overstate the actual risk to golfers who play on treated courses. Therefore, the Agency finds
that mitigation is unnecessary for post-application exposure to golfers.

       The most significant human risk concern relates to cancer risk for handlers who mix, load, and
apply diclofop-methyl to agricultural sites. To a large extent, this concern can be mitigated by handlers
using appropriate engineering controls, such as closed systems and enclosed application equipment

       In addition, EPA has identified a potential acute risk to small herbivorous mammals when
repeated spot applications of diclofop-methyl are applied to turf. The Agency has also identified a risk
to non-target terrestrial plants.

       To mitigate the few risks of concern associated with diclofop-methyl as part of making the
decision to reregister this pesticide, EPA finds a number of label amendments are necessary.  Results of
the risk assessments, and required label amendments to mitigate those risks, are presented in this RED.
       The Agency has concluded that the tolerances for diclofop-methyl meet the Food Quality
Protection Act (FQPA) safety standards.  Existing tolerances on plant commodities have been
reassessed and new tolerances on plants and animals will be established.

Dietary Risk flFood and Water!

       The acute and chronic dietary exposure assessments for diclofop-methyl are analyses that
incorporate percent crop treated information and anticipated residues. The acute dietary risk estimate
for females (13-50 years old) is less than 8% of the acute population adjusted dose at the 99.9th
percentile. The chronic dietary analysis indicates no risk of concern for any population subgroup, with
an estimate of less than 1% of the chronic population adjusted dose for the highest exposed population
subgroup (children 1-6 years old). Using modeling estimates, acute and chronic drinking water levels
of comparison (DWLOC's) find that food and drinking water exposures do not exceed the Agency's
level of concern; therefore, no specific mitigation is warranted.

       The carcinogenic dietary risk for diclofop-methyl is estimated to be 1.2 x 10~6, which is
nearly equivalent to the level (lO"6) generally considered negligible by the Agency. This estimate is
based on the estimated average dietary exposure of the general U.S. population, multiplied by the
upper-bound potency factor (Ch*) of 2.3 x I0~l (mg/kg/day)'1.  Diclofop-methyl is classified as a likely
human carcinogen based on laboratory studies in the rate and the mouse. The dietary carcinogenic risk
estimate appears above the level of concern because various input parameters to the assessment such
as the estimate for the percentage (15%) of dairy cattle grazing in diclofop-methyl treated wheat fields,

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express protective assumptions. A DWLOC for cancer was not calculated. Based on the Agency's
knowledge of environmental fate properties and limited monitoring data on diclofop-methyl, there is no
concern for carcinogenic exposure in food and water.

Non-Occupational Post-Application Risk (Golfers)

       The non-cancer risk estimate is not of concern for post-application exposure to golfers who
play on a course treated with diclofop-methyl. Non-cancer risk estimates indicate that entry by golfers
to a treated golf course results in a margin of exposure (MOE) well over 100 on the day of application,
as soon as the spray has dried.

       Cancer risk for golfers is 2.2 x 10"6 based on exposure on the day of application at the typical
application rate of 1 Ib active ingredient/acre (ai/A). The Agency believes that the cancer risks
associated with golfers on diclofop treated turf is an upper-bound estimate since the post-application
risk assessment is based on protective assumptions related to golfer behavior and diclofop-methyl use
practices.  The risk is overestimated because the Agency assumes the golfer is exposed continuously
during a round of golf (four hours, assuming the entire course is treated), two days per year, for 50
years.  But because diclofop-methyl is usually applied as a spot treatment covering less than the entire
course, the golfer would be exposed for a much shorter duration (probably Vz hour rather than four
hours). The odds of a golfer encountering diclofop-methyl treatment twice a year for a lifetime is also a
remote probability. The Agency is therefore not concerned with cancer risks to goffers exposed to
residues of diclofop-methyl on treated turf.

Aggregate Risk

       Under the Food Quality Protection Act, the Agency considers contributions to risk from
various exposure sources, specifically food, drinking water, and non-occupational sources  (e.g., golfers
on treated courses).  Four aggregate risk assessments were calculated for diclofop-methyl.

       The acute aggregate risk estimate for diclofop-methyl addresses exposure from  food and
drinking water on a single day. Acute dietary food risks for females  13-50 years old are below the
Agency's level of concern (<100% aPAD). The modeled concentrations of diclofop-methyl in
groundwater and surface water are also below the Agency's level of concern for exposure to diclofop-
methyl in drinking water.  Based on the available information, the Agency concludes that residues of
diclofop-methyl in drinking water (when considered along with exposures from food uses) would not
result in an acute aggregate human health risk of concern.

       The short-term aggregate risk assessment considers exposure from food, water, and non-
occupational sources of exposure to a pesticide.  Non-occupational, dermal short-term exposure (one
to seven days) is likely to occur on golf courses, where diclofop-methyl may be applied within a few
hours prior to golfer play. Calculated short-term DWLOC's do not exceed the Agency's level of

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 concern as a contribution to short-term aggregate exposure. Based on available information, the
 Agency concludes that aggregate residues of diclofop-methyl in food and drinking water, combined
 with golfer exposure do not result in a short-term risk estimate of concern.

        Chronic (non-cancer) aggregate risk estimates for diclofop-methyl addresses long-term
 exposure from food, drinking water, and non-occupational sources of exposure. No chronic non-
 occupational sources of exposure were identified for diclofop-methyl. Therefore, the chronic aggregate
 exposure assessment addresses exposure from food and drinking water only. Chronic dietary food
 risks are below the Agency's level of concern (<100% cPAD) for all population subgroups. The
 modeled concentration of diclofop-methyl in groundwater and surface water is also below the Agency's
 level of concern for exposure to diclofop-methyl in drinking water as a contribution to chronic
 aggregate risk.

        The cancer aggregate risk estimate to diclofop-methyl addresses the combined carcinogenic
 exposure from food, drinking water, and non-occupational sources of exposure (in this case, exposure
 to golfers). The Agency does not believe that exposure to residues of diclofop-methyl in food and
 drinking water contribute to an aggregate risk of concern for the general population. The food cancer
 risk is based on certain protective exposure assumptions and the water cancer risk is based on
 screening level modeling estimates.  When considering the existing environmental fate data, the Agency
 also concludes that diclofop-methyl is unlikely to reach surface and groundwater.

        As part of the cancer aggregate risk, the carcinogenic risk to golfers is 2.2 x 10"6. Any
 aggregation of carcinogenic exposure to golfers with carcinogenic exposure from food and drinking
 water would ordinarily increase the risk further above the level of concern. In this case, golfer exposure
 to diclofop-methyl is probably much less than the assessment indicates.  Because the cancer risk
 estimate to golfers is based on high-end assumptions and may possibly overestimate risk, aggregation
 with food and drinking water estimates does not result in a meaningful estimate of aggregate
 carcinogenic exposure. The Agency concludes that there is neither an aggregate carcinogenic concern
 for the general population nor for golfers who play on diclofop-methyl treated courses.

 Occupational Risk -  and Risk Management

        The Agency evaluated seven potential exposure scenarios for mixers, loaders, applicators, and
 other handlers associated with diclofop-methyl use patterns. The assessment includes handlers involved
 in mixing/loading and applying liquids for hand gun sprayer, groundboom and aerial applications.

        Non-cancer handler risk is based on combined dermal and inhalation exposures for short-
 and intermediate term exposure durations. The assessment indicates that MOEs are generally not of
 concern, except for handlers involved in aerial application. Assuming handlers only wear personal
protective equipment (PPE), the handlers supporting aerial application have MOEs of concern (MOE

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of 60 for the mixer/loader). However, when assuming the use of engineering controls, the MOEs are
greater than 100 for all handlers.

       Cancer handler risk for dermal and inhalation exposure range from 1.4xlO"2 to S.lxlO"6 at
the baseline level, 8.4xlO"5 to 6.0xlO"7 with personal protective equipment (PPE), and 5.8x10"5 to
1.4x10"6 at the engineering controls level. The Agency is generally concerned when cancer risk
estimates are greater than 1 x 10"6.  The Agency found that exposure to wheat and barley handlers
could be substantially reduced by .employing appropriate engineering controls, such as closed
mixing/loading systems and enclosed application equipment To minimize the occupational cancer risk
to such handlers, the registrant has agreed to implement engineering controls to reduce exposure to all
handlers.

Occupational Post-Application Risks

       Several occupational post-application exposure scenarios were evaluated by the Agency. Post-
application risk scenarios include workers who mow and maintain golf course turf grass and workers .
who scout in wheat and barley fields.

       Non-cancer post-application risk estimates for workers indicate that entry by golf course
workers to mow/maintain turf grass is not of concern on the day of application as soon as the sprays
have dried. Similarly, the MOE for reentry by workers into wheat or barley fields for scouting is also
not of concern on the day of application.

       Cancer risk for post-application exposure to workers mowing/maintaining golf course turf is
6.1xlO"6 on the day of application at a rate of 1.0 Ibs. ai/A. Because the label discourages mowing for
36 hours for efficacy reasons, the actual risk to mowers is less than the Agency's risk estimate. The
calculation of cancer risk for workers scouting wheat and barley is 2.3x10"5 on the day of application.
The  Agency does not anticipate the need for wheat and barley scouts to reenter a treated field prior to
the end of the REI. For these reasons, the Agency is not concerned about the post-application cancer
risk to workers associated with diclofop-methyl use. The restricted entry interval (REI) for wheat and
barley, 24 hours, should be maintained based on the carcinogenicity of the active ingredient.

Ecological Risk

       Most risk quotient estimates show low risk to various non-target organisms.  The Agency has,
however, identified certain ecological risks of potential concern. Although there are remaining
uncertainties, diclofop-methyl poses a risk of reproductive toxicity to mammals on an acute basis and
may also pose a chronic risk to mammals.  Runoff and spray drift from diclofop-methyl poses a high
risk  to nontarget grasses and sedges, and in the absence of appropriate toxicity data on nontarget
aquatic plants, may pose high risk for these species. Revised label language on reducing spray drift will

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               help to reduce exposure to non-target organisms. Additional information will also be provided by the
               registrant to confirm that there is no chronic risk to mammalian species.

                      The Agency is issuing this RED for diclofop-methyl, as announced in a Notice of Availability
               published in the Federal Register. A sixty day public comment period will be provided. This RED
               document includes guidance and time frames for complying with any required label changes for
               products containing diclofop-methyl.
_

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I.      Introduction

       The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregistration of products with active ingredients registered prior to November 1,1984.
The amended Act calls for the development and submission of data to support the reregistration of an
active ingredient, as well as a review of all submitted data by the U.S. Environmental Protection Agency
(referred to as EPA or "the Agency").  Reregistration involves a thorough review of the scientific
database 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" criteria of FIFRA.

       On August 3,1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law.
This Act amends FIFRA to require tolerance reassessment of all existing tolerances.  The Agency had
decided that, for those chemicals that have tolerances and are undergoing reregistration, the tolerance
reassessment will be initiated through this reregistration process. It also requires that by 2006, EPA
must review all tolerances in effect on the day before the date of the enactment of the FQPA, which
was August 3,1996. FQPA also amends the FFDCA to require a safety finding in tolerance
reassessment based on factors including an assessment of cumulative effects of chemicals with a
common mechanism of toxicity. Although FQPA significantly affects the Agency's reregistration
process, it does not amend any of the existing reregistration deadlines. Therefore, the Agency is
continuing its reregistration program while it resolves the remaining issues associated with the
implementation of  FQPA.

        The implementation of FQPA has required the Agency to revisit some of its existing policies
relating to the determination and regulation of dietary risk, and has also raised a number of new issues
for which policies need to be created. These issues were refined and developed through collaboration
between the Agency and the Tolerance Reassessment Advisory Committee (TRAC), which was
composed of representatives from industry, environmental groups, and other interested parties. The
TRAC identified the following science policy issues it believed were key to the implementation of
FQPA and tolerance reassessment:

               Applying the FQPA 10-Fold Safety Factor                                :
        •       Whether and How to Use "Monte Carlo" Analyses in Dietary Exposure Assessments
        •       How to Interpret "No Detectable Residues" in Dietary Exposure Assessments
               Refining Dietary (Food) Exposure Estimates
        •       Refining Dietary (Drinking Water) Exposure Estimates
        •       Assessing Residential Exposure
        •       Aggregating Exposure from all Non-Occupational Sources
        •.       Whether and How to  Use Data Derived from Human Studies

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       The process developed by the TRAC calls for EPA to provide one or more documents for
public comment on each of the policy issues described above. Each of these issues is evolving and in a
different stage of refinement. Some issue papers have already been published for comment in the
Federal Register and others will be published shortly.

       This document consists of six sections.  Section I contains the regulatory framework for
reregislration/tolerance reassessment. Section II provides a profile of the use and usage of the
chemical.  Section III gives an overview of the revised human health and environmental effects risk
assessments resulting from public comments and other information.  Section IV presents the Agency's
reregistration eligibility and risk management decisions.  Section V summarizes the label changes
necessary to implement the risk mitigation measures outlined in Section IV. Section VI provides
information on how to access related documents. Finally, the Appendices lists Data Call-In (DCI)
information. The revised risk assessments and related addenda are not included in this document, but
are available on the Agency's web page at www.epa.gov/pesticides/diclofop-methyl and in the Public
Docket

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II.
Chemical Overview
       A.    Regulatory History

             Diclofop-methyl was first registered in the United States in 1982 for the control or
       suppression of wild oats and annual grasses in wheat and barley. It is currently also registered
       for weed control on established bermuda grass on golf courses. The use of diclofop-methyl on
       golf courses is authorized under Section 24(c) of FIFRA in the states of AL, AR, FL, GA, LA,
       MS, NC, OK, SC, TN, and TX.
       B.
       Chemical Identification
           Chemical Name:
                           Methyl 2-(4-(2,4-dichlorophenoxy)phenoxy)-propanoate
                                              •**  r'
       •   Common Name:

       •   Chemical Family:

       •   Case Number:

       •   CAS Registry Number:

       •   OPP Chemical Code:

       •   Empirical Formula:

       •   Molecular Weight:
                                  Diclofop-methyl

                                  Aryloxyphenoxy propionate

                                  2160

                                  51338-27-3

                                  110902
                                  341.2

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       •   Trade & Other Names:

       •   Basic Manufacturer:
Hoelon® andllloxan®

Aventis Crop Science
       Diclofop-methyl is a colorless, crystalline solid with a melting point of 39-41° C; density of
1.30±0.05 g/cm3 at 40°C; octanol/water partition coefficient (Pow) of 37,800; and vapor pressure of
1.9 x 1Q-6 mm Hg at 20° C.  Diclofop-methyl is practically insoluble in water (0.3 mg/100 mL), and is
soluble in xylene (253 g/100 mL), acetone (249 g/100 mL), and ethanol (11 g/100 mL).

       •    Use Profile

            The following information is based on the currently registered uses of diclofop-methyl:

            Type of Pesticide:  Herbicide

            Summary of Use Sites:

            Food: Wheat and Barley

            Residential: None

            Public Health:  None.

            Other Nonfood: Golf Course (Turf).  (Of the existing turf-related uses on current Special
           Local Need or Section 24(c) product registrations, the registrant is only supporting the turf
           use on golf courses.)

           Target Pests: Controls wild oats and annual grassy weeds in wheat and barley, as
                     well as goosegrass in established bermudagrass turfs on golf courses.
                     Specifically, diclofop-methyl is used for the control of annual rye grass,
                     broadleaf signal grass, crab grass, fall panicum, barnyard grass, water grass,
                     foxtail grasses, goose grass, wild oats, itch grass, raoul grass, persian darnel,
                     volunteer corn, witch grass (suppression), smallseed canary grass, and spring
                     millet grass.

           Formulation Types Registered: Formulated as a manufacturing product (93% active
                     ingredient (ai)) and as an emulsifiable concentrate (34.7% ai)
                                             10

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           Method and Rates of Application:
                     Equipment - Applied by fixed-wing aircraft, tractor-drawn equipment,
                     hand held equipment
and
                     Method and Rate - Broadcast; soil incorporated treatment; spray. The current
                     maximum label rate is 1.0 Ib ai/A for use on wheat and barley. In addition, the
                     registrant is supporting the golf course turf use at a maximum rate of 1 Ib ai/A
                     (per treatment) and a seasonal maximum of 1.5 Ib ai/A (per year). There is a
                     maximum of one application per growing season on wheat and barley and a
                     maximum of two applications on golf course turf (not to exceed the golf course
                     turf seasonal maximum of 1.5 Ib ai/A/year).

                     Timing - May be applied pre-plant, pre-emergent, or post-emergent (over 90%
                     of diclofop-methy 1 usage is post-emergent)

           Use Classification: Restricted Use Pesticide (due to carcinogenicity in mice)

       C.  Estimated Usage of Pesticide

       This section summarizes the best usage estimates available for diclofop-methyl. A full listing of
all uses of diclofop-methyl, with the corresponding use and usage data for each site, has been
completed and is in the "Quantitative Use Assessment" document, which is available in the public
docket. The data, reported on an aggregate and site (crop) basis, reflect annual fluctuations in use
patterns as well as variability in using data from various information sources. Approximately 750,000
Ibs al of diclofop-methyl are used annually, according to Agency and registrant estimates. The use of
diclofop-methyl has been decreasing due to the introduction of other herbicides.

Table 1. Diclofop-Methyl Estimated Usage for Representative Sites
Crop/Site
Wheat
Barley
Golf Course
Lbs. Active Ingredient'
', ^Applied (WfcAvg.)'
610,000
130,000
16,000
Percent Crop Treated
(Likely Maximum)
2%
4%
2%
JPercent Crop Treated
. (WtAvg.)
1%
1%
1%
'Weighted Average is based on data for 1987 -1996; the most recent years and more reliable data are weighted more heavily.
                                             11

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 ffl.    Summary of Diclofop-Methyl Risk Assessment

        Following is a summary of EPA's revised human health and ecological risk findings and
 conclusions for diclofop-methyl, as fully presented in the documents, "The BED Chapter of the
 Reregistration Eligibility Decision Document (RED)," dated August 10,2000, and "EFED RED
 Chapter for Diclofop-Methyl," dated July 26,2000. The purpose of this summary is to assist the
 reader by identifying the key features and findings of these risk assessments, and to better understand
 the conclusions reached in the assessments.

        A.     Human Health Risk Assessment

        EPA provided a copy of the preliminary risk assessment for diclofop-methyl to the registrant in
 May of 2000 for identifying any errors in the Agency's analysis.  In response to registrant comments,
 the risk assessments were updated and refined.  Revisions to the human health risk assessment are
 listed below:

 •       Revised the short-term inhalation endpoint from a chronic feeding study in the rat to the more
        appropriate 90-day feeding study in the rat.

 •       Updated the dietary risk assessment to incorporate the percentage that cattle forage in
        diclofop-methyl treated fields.

        Revised the conclusion on endocrine disruptor effects of diclofop-methyl, clarifying that the
        mammalian toxicity data does not provide evidence that diclofop-methyl causes effects related
        to disruption of the endocrine system.

               1.     Dietary Risk from Food

                     a.     Toxicity

        The Agency has reviewed all toxicity studies submitted and has determined that the toxicity
database is complete.  The reregistration eligibility determination is therefore supported for all currently
registered uses.

                     b.     FQPA Safety Factor

       The FQPA Safety Factor is intended to provide up to an additional 10-fold safety factor
(10X), to safeguard against a special sensitivity in infants and children to specific pesticide residues in
food or to compensate for an incomplete database. The Agency reduced the FQPA Safety Factor to
IX after evaluating the hazard and exposure data for diclofop-methyl. The FQPA Safely Factor was
reduced to IX for the following reasons:
                                             12

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1.     The toxicology database is complete for the assessment of the effects following in utero and/or
       postnatal exposure to diclofop-methyl;

2.     There is no indication of quantitative or qualitative increased susceptibility of rats or rabbits to
       in utero and/or postnatal exposure to diclofop-methyl in the available toxicity data;

3.     The Agency determined that a developmental neurotoxicity study is not required for diclofop-
       methyl;

4.     Adequate monitoring data, surrogate data, and/or modeling outputs are available to
       satisfactorily assess dietary and non-occupational sources of exposure and to provide a
       screening level drinking water exposure assessment  The assumptions and models used in the
       assessments do not underestimate the potential risk for infants and children.

                     c.      Population Adjusted Dose (PAD)

       The PAD is a term that characterizes the dietary risk of a chemical, and reflects the Reference
Dose (RfD), either acute or chronic, that has been adjusted to account for the FQPA safety factor (i.e.,
RfD/FQPA safety factor). In the case of diclofop-methyl, the FQPA safety factor is 1; therefore, the
acute or chronic RfD equals the acute or chronic PAD.  A risk estimate that is less than 100% of the
acute or chronic PAD  is not of concern.

                     d.     Summary of Toxicological Endpoints

       Three toxicological endpoints from animal studies were selected for evaluating the dietary risk
to diclofop-methyl, corresponding to the acute dietary risk, chronic dietary risk (non-cancer), and
chronic dietary risk (carcinogenicity) assessments. In addition to considering the FQPA Safety Factor
discussed above, the Agency applied the conventional uncertainty factor (UF) of 100 to account for
both for interspecies extrapolation (10X) and for intraspecies variability (10X).

       The acute RfD of 0.1 mg/kg/day for females (13-50 years old) is derived from the
developmental toxicity study in the rat.  The acute endpoint was based on significant decreases in fetal
body weight and crown-rump length, distended ureters, and skeletal abnormalities at the Lowest-
Observed-Adverse-Effect-Level (LOAEL) of 32 mg/kg/day. The no-observed-adeverse-effect-level
(NOAEL) for the pups was established at 10 mg/kg/day. The study and endpoint selected are
considered appropriate since it is assumed that the fetal effects could have resulted from a single
exposure in utero.  The LOAEL for maternal systemic toxicity was established at 10 mg/kg/day. A
NOAEL for maternal  toxicity was not established. No appropriate endpoint was identified for the U.S.
general population, including infants and children. There were no effects observed in oral toxicology
studies (including maternal toxicity in the developmental toxicity studies in rats and rabbits) that are
                                              13

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 attributable to a single exposure (dose) and applicable to the general population and other sub-
 populations.

        The chronic RfD of 0.0023 mg/kg/day is derived from a combined chronic
 feeding/carcinogenicity study in the rat, and was calculated as the NOAEL (0.23 mg/kg/day) divided
 by an UF of 100X (10X for interspecies extrapolation and 10X for intraspecies variability).  The
 chronic endpoint was based on increased absolute and relative liver and kidney weights, increased ALT
 (alanine arninotransferase), AST (aspartate aminolransferase), and AlkP (alkaline phosphatase)
 activities, impaired lipid and protein metabolism, and histopathology (hypertrophy, Hpofuscin storage) in
 males and females at the LOAEL of 2.3 mg/kg/day.

        For the cancer risk assessment, the Agency used a positive carcinogenicity study in mice which
 found a NOAEL of 0.24 mg/kg/day in males and 0.25 mg/kg/day in females. The LOAEL for systemic
 toxicity was established at 0.76 mg/kg/day and was based on clinical chemistry findings of relative
 organ weights in males and females. Electron-micrographs revealed peroxisome proliferation in the
 livers of high-dose animals.  Based on the results of the mouse study, as well as a carcinogencity study
 in the rat (MRID 43927302) which also exhibited adenomas and carcinomas, diclofop-methyl was
 classified as a likely human carcinogen with a Qj* of 2.3 x lO'^mg/kg/day)'1.

       Diclofop-methyl is classified as a likely human carcinogen based on laboratory studies in the rat
 and the mouse. However, the registrant believes that a linear low dose approach based on liver tumors
 in mice should not be used for the cancer risk assessments.  The Agency has discussed the mode of
 action of liver carcinogenicity of diclofop-methyl and determined that data demonstrating peroxizome
proliferation were very limited and consisted of high-dose animals from a mouse oncogenicity study and
 a 90-day feeding study in the rat Control or intermediate dose animals were not examined, which
makes evaluation of possible dose-response relationships impossible to determine. Also, peroxizome
measurements did not substantiate what the Agency believes is the most sensitive indicator of
peroxizome proliferation, catalase activity in the mouse. Therefore, the Agency is using a linear low-
dose approach (Q*) to assess chronic cancer risk to diclofop-methyl. The Agency's detailed analysis
on the toxiciry of diclofop-methyl can be found in the August 10,2000 Human Health Risk Assessment
as well as the "HED Response To Comments" document A brief overview of the studies used for the
dietary risk assessment is outlined in Table 2 in this document
                                             14

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Table 2: Human Dietary Risk Assessment of Diclofop-Methyl
Assessment ^
^
Acute Dietary
(females 13-50)
Acute Dietary
(General
Population,
including infants
and children)
Chronic Dietary
(Non-cancer)
Chronic Dietary
(Carcinogenic)
Dose
(rag/kg/day)
> *" '
NOAEL=10
None
NOAEL=0.23
Q,*=2.3 x 10-'
(mg/kg/day)r1
• Endppint ;
< -f ' , - •*
Decreased fetal body
weights, extendedureters,
skeletal abnormalities.
Effects attributed to a
single dose
No endpoint selected
Increased relative liver
andkidney weights, liver
histopathology
(hypertrophy lipofuscin
storage).
Liver Adenomas and
Carcinomas with
significant pair-wise
comparisons.
• Study .
••*
Developmental
Toxicity Study in the
Rat
(MRID 92036042)
None
Chronic Toxicity
Study in the Rat
(MRID 43927302)
Carcinogenicity Study
in the Mouse
(MRID 92036058)
UF
*~s7
100

100
N/A
FQPA
'Safety
Factor
1

1

PAD - *
(mf/kg/day)
0.1

0.0023

                     e.     Exposure Assumptions (Food)

       Dietary risk assessment for diclofop-methyl is based on estimates of diclofop-methyl and/or its
metabolites that may occur in barley grain and wheat grain. The assessment also includes the possible
occurrence of diclofop-methyl residues in milk or animal tissues due to the feeding of treated grain, hay,
or forage to dairy and beef cattle.

Submitted Data;  Dietary risk assessment for diclofop-methyl is based, in part, on magnitude of the
residue (field trial data) and processing studies submitted by the registrant in support of the
reregistration of diclofop-methyl on wheat and barley grain, hay, and forage. The dietary risk
assessment for diclofop-methyl is also based on submitted niminant and poultry feeding studies that
established the level of residue transfer to animal tissue, milk, and eggs.

Monitoring Data: Under the Pesticide Data Program (POP), the USDA sampled wheat grain for
diclofop-methyl in 1995 (600 samples), 1996 (340 samples), and 1997 (623 samples).  Of these
samples, there are two detections reported at 0.009 ppm and 0.01 ppm. The Limit of Detection
(LOD) was described as 0.006 ppm for all samples.

       FDA domestic surveillance data (years 1992-1998) is also available for diclofop-methyl
residue in whole grain barley, whole grain wheat, processed wheat commodities, whole milk, and milk
                                             15

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 products including cream and cheese. There are no reported detections of diclofop-methyl in any
 samples. Data indicate the Limit of Quantitation (LOQ) for FDA milk samples does not exceed 0.01
 ppm. In addition, the analytical method employed by FDA may not include all of the pertinent
 metabolites of diclofop-methyl and as a result, the FDA data are not fully usable for risk assessment
 purposes. There are also no FDA surveillance data for diclofop-methyl residues in animal tissue.

 Metabolites of Diclofop-Methyl;  Diclofop-methyl metabolizes in plants and animals, and degrades
 in the environment to form various chemical species.  For the tolerance expression of diclofop-methyl,
 the Agency has determined the residues of concern for plants are diclofop-methyl and its metabolites,
 2-[4-(2,4-dichlorophenoxy)phenoxy]propanoic acid (hereafter referred to as "diclofop acid") and 2-
 [4-(2,4-dichloro-5-hydroxyphenoxy)phenoxy] - propanoic acid (hereafter referred to as "hydroxy
 diclofop") and hydroxy conjugates. For animals, the residues of concern are diclofop-methyl and its
 metabolite, diclofop acid.

 Usage Data; Annual usage of diclofop-methyl has been estimated by the EPA using information from
 USDA's National Agricultural Statistics Service, The National Center for Agricultural Food and Policy,
 and other data sources. Estimates have been made, per commodity, of the weighted average yearly
 use and the estimated maximum yearly use.

       Diclofop-methyl is estimated to be currently used on less than 1% of the total U.S. barley crop.
 Diclofop-methyl usage on wheat varies somewhat according to variety, with an estimated use of 1.2%
 used on winter wheat (winter wheat accounts for approximately 50% of total wheat produced), 0.4%
 use on spring wheat, and an estimated 12% use on durum wheat (durum wheat accounts for <4% of
 total wheat production). Total usage on wheat is estimated to be less than 2% of all wheat grown in the
 U.S.

       Most diclofop-methyl usage is post-emergence (>90%), which suggests the potential
 importance of livestock exposure via foraging of treated wheat. The chronic risk assessment assumes,
 at most, 15% of dairy cattle consume  wheat forage, a practice resulting in possible residues in milk.
 Data indicate that barley is not a significant forage item.

                            i.      Residue Estimates for Acute Dietary (food) Risk:

       The Dietary Exposure Evaluation Model (DEEM™) program for acute dietary exposure is
 based on each individual record of consumption from USDA's Continuing Survey of Food Intake by
 Individuals (CSFII). The program produces a distribution (from the 10th to the 99.9th exposure
percentile) of daily exposures for individuals comprising the U.S. population and/or population
 subgroups (for this assessment, females 13-50 years of age). Acute dietary exposure (as calculated
through DEEM™) is compared to the acute population adjusted dose (aPAD), which is the dose at
which an individual could be exposed on any given day and no adverse health effects would be
                                             16

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expected, accounting for the FQPA safety factor. Acute dietary exposure that is less than 100% of the
aPAD is not of concern.

Wheat/Barley Grain; The combined residues of diclofop-methyl and its metabolites, diclofop acid
and hydroxy diclofop were non-detectable (< 0.10 ppm) in field trial studies in/on wheat and barley
grain. Wheat and barley processing data demonstrate that residues of diclofop-methyl and its
metabolites, diclofop acid and hydroxy diclofop, do not concentrate in bran, flour, or other processed
fractions following post-emergence foliar application at five times the label rate.

       Because wheat and barley grain are blended commodities, the residue estimate for risk
assessment is based on a number of key  assumptions, including 1A the LOQ (0.05 ppm in field trial
studies), a (reduction) factor of 0.2 based on processing data at five times the label rate, and the
percent of total crop treated (2% for wheat and 4% for barley). On this basis, the residue estimates for
acute risk assessment are 0.2 ppb for wheat and 0.4 ppb for barley.

       The extrapolated values  are considered to be of higher confidence than the PDP/FDA
monitoring samples taken from the whole grain. As mentioned previously, the analytical methyl
employed by FDA may not have included all of the pertinent metabolites of diclofop-methyl and as a
result, the FDA data are not fully useable for risk assessment purposes. Thus, the extrapolated values
were selected for the risk assessment and the monitoring data helps to confirm the estimates used.

Animal Tissues; Metabolism studies have demonstrated a transfer of diclofop-methyl and diclofop
acid to animal tissue (rneats/fat/intemal organs). Lacking monitoring data for these commodities, this
aspect of the acute dietary risk assessment relies solely on extrapolated residue levels, based on an
estimate of the possible exposure, or burden, to livestock from treated items, and transfer factors
derived from ruminant and poultry feeding studies.  Data from the poultry feeding study and an estimate
of a low dietary residue burden for poultry led to a decision that a tolerance is not required for eggs or
other poultry products. On the same basis,  poultry products were not a factor in the dietary risk
assessment.

       A dietary burden reflecting a theoretical maximum exposure to diclofop-methyl for beef cattle
(extrapolated to goats and sheep) and swine, is based on the feed items of wheat grain, wheat forage,
and barley hay (and for acute assessment assumes 100% treatment of each item). Residue estimates
for wheat forage (the most significant contribution to the diclofop-methyl dietary burden) are based on
field trial measurements at day 26 following postemergence treatment  Although residue measurements
for forage at day 10 following application were used to establish tolerances, the 26-day interval from
application to foraging is considered a better estimate of actual agricultural practices and more suitable
for risk assessment (the registrant has agreed to modify the current restriction on the diclofop-methyl
label to preclude grazing for 28  days). From these data, a dietary burden of 1.86 ppm was established
for beef cattle and a dietary burden of 45 ppm established for swine, based on wheat grain only.
                                              17

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        Ruminant feeding data were used to derive estimates of residue transfer from plant feed items to
liver, kidney, fat, and muscle of beef cattle, and swine tissue.  Since the assessment is for acute, or
maximum exposure, the highest measured residue from the feeding study dose level most closely
corresponding to the estimated dietary burden (1.86 ppm) was used to calculate the final transfer factor
for each of the above tissues.

        Based on the data outlined above (residue burden x transfer factor), the residue estimates for
acute dietary risk from ruminant tissues are: 46 ppb in meal/byproducts,  130 ppb in fat, 840 ppb in
kidneys, and 220 ppb in liver. Swine tissue residue estimates, which are based on wheat grain only, are
assessed at:  1 ppb in meat/byproducts, 3 ppb in fat, 20 ppb in kidney, and 5.4 ppb in liver.

Milk: Although extensive FDA surveillance monitoring data is listed for diclofop-methyl in milk and
milk products (with no detections of diclofop-methyl or metabolites), the Agency decided not to use the
FDA data in the risk assessment.  This decision was made because it could not be determined if the
FDA multi-residue method (The Pesticide Analytical Manual (PAM)- Volume II) identified the
diclofop-methyl metabolites expected in milk.

        The dietary burden for dairy cattle was estimated as above, except averaged residues from field
trial studies were used instead of maximum residues to account for the blending that occurs in milk
processing.  Transfer factors were based on residues measured from the feeding study dose level most
closely corresponding to the estimated dietary burden of 3.04 ppm.

        Based on the data outlined above (residue burden x transfer factor), the residue estimates for
acute dietary risk from dairy products are: 0.31 ppm in whole milk, 0.015 ppm in skim milk, and 0.79
ppm in cream (milk fat).

                             ii.     Residue Estimates for Chronic and Carcinogenic Dietary
                                    (Food) Risks:

        Chronic dietary exposure estimates are based on averaged consumption data for the entire
U.S. population, and within population subgroups such as "all infants." For this  assessment, the
averaged consumption estimate of each population group is multiplied by residue estimates for
wheat/barley grain, livestock tissue, and milk. Chronic dietary exposure estimates are calculated by the
DEEM™ program, and chronic dietary risk is calculated as a percent of the cPAD.

       No appropriate endpoint was identified for the U.S. general population, including infants and
children. There were no effects observed in oral toxicology studies (including maternal toxicity in the
developmental toxicity studies in rats and rabbits) that are attributable to a single exposure (dose).

Wheat/Barley Grain; The combined residues of diclofop-methyl and its metabolites, diclofop acid
and hydroxy diclofop were non-detectable (O.10 ppm) in/on wheat and barley grain in field trial

                                              18

-------
studies. Wheat and barley processing data demonstrate that residues of diclofop-methyl and its
metabolites, diclofop acid and hydroxy diclofop, do not concentrate in bran, flour, etc. following post-
emergence foliar application at 5x the label rate. Because wheat and barley grain are blended
commodities, the residue estimate for risk assessment is based on Vz the LOD (0.05 ppm in field trial
studies), a reduction factor of 0.2 based on processing data at 5x label rate, and factored for the
percent of total crop treated (2% for wheat and 0.5% for barley).  On this basis, the residue estimates
for chronic risk assessment are 0.05 ppb for barley grain (and processed commodities) and 0.2 ppb for
wheat grain (and processed commodities).

Animal Tissues; Residue estimates for chronic risk assessment for ruminant meats (and pork) were
derived from the estimates summarized above for acute risk assessment.  However, each chronic
residue estimate has been factored for percent crop treated data, with the intent to more accurately
reflect the variations of exposure expected over the long-term (cancer risk is based on the assumed
lifetime exposure).

        Based on the data outlined above (residue burden x transfer factor x percent crop treated) the
residue estimates for chronic dietary risk from residues in ruminant tissues are: 0.9 ppb in
meat/byproducts, 2.5 ppb in fat, 17 ppb in kidney, and 4 ppb in liver.  Swine tissues are estimated at:
0.02 ppb in meat/meat byproducts, 0.04 ppb in fat, 0.4 ppb in kidney, and 0.09 ppb in liver.

Milk;  Residue estimates for the chronic risk assessment for milk (and milk products) were derived
from the residue estimates summarized above for the acute assessment. However, estimates for
chronic risk assessment were adjusted for percent crop treated (1.6% for wheat forage) and for the
estimated percent of total dairy cattle that may forage spring or winter wheat The estimate for dairy
cattle foraging, believed to be an upper-bound estimate, is 15% of total dairy cattle.

        Based on the data outlined above (average residue burden x average transfer factor x percent
crop treated x percent forage), the residue estimate for chronic dietary risk from milk and milk products
is: 0.5 ppb (0.5 ppb is entered for each milk category in the DEEM program: non-fat solids, fat solids,
sugar, and water).

              2.      Food Risk Characterization

                      a.     Acute Dietary (food) Risk:

        Generally, a dietary risk estimate that is less than 100% of the acute or chronic Population
Adjusted Dose is not of concern. The diclofop-methyl acute dietary risk from food is well below the
Agency's level of concern; that is, less than 100% of the acute PAD is utilized for females 13-50 years
old. The results indicate that females (ages 13-50) are acutely exposed to diclofop-methyl at 8% of the
aPAD (at the 99.9th exposure percentile). Table 3 below presents a summary  of acute dietary risk to
diclofop-methyl.
                                              19

-------
                      b.     Chronic Dietary (food) Risk:

        As previously mentioned, the DEEM™ model was used to calculate chronic dietary exposure
 estimates based on average consumption data for the U.S. population and U.S. population subgroups
 including infants and children.  Based on the residue and percent crop treated data outlined above, the
 DEEM™ model estimates that all population subgroups, including infants and children, are chronically
 exposed to diclofop-methyl at a level less than, or equal to, 1% of the respective cPAD. Table 3
 below presents a summary of chronic dietary risks to diclofop-methyl.

 Table 3; Refined Acute and  Chronic Dietary Risk Estimates
Population
U.S. General Population
Children (1-6 years)
AH infants (< 1 year)
Females (13-50)
Acute Dietary (99.9th percentile)
Exposure (mg/kg/d)
n/a
n/a
n/a
0.007558
%aPAD
n/a
n/a
n/a
<8%
Chronic Dietary
Exposure (mg/kg/d)
0.000005
0.000016
0.000007
0.000003
•.,-..>%*J»;AJ).
<1%
<1%
<1%
<1%
                      c.      Carcinogenic Dietary (food) Risk

       As previously discussed, a carcinogenic risk for diclofop-methyl is quantified, based on the
estimated average dietary exposure of the general U.S. population (0.000005 mg/kg bw/day) multiplied
by the upper-bound potency factor (Q,*) of 2.3 xlO'1 (mg/kg/day)-1. On this basis, the upper-bound
carcinogenic risk estimate for diclofop-methyl is calculated to be 1.2 x 10'6, which is the level generally
considered negligible by the Agency (10"6).

              3.      Dietary Risk from Drinking Water

       Drinking water exposure to pesticides can occur through ground water and surface water
contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks and
uses either modeling or actual monitoring data, if available, to estimate those risks. Modeling is
considered to be. an unrefined assessment and provides a high-end estimate of exposure.

       Limited domestic surface and ground water monitoring data were available in the STORET
data base (from 1989-1992) for diclofop-methyl and diclofop acid.  All of the data were from ambient
waters in Minnesota, Idaho, and Colorado. Reported concentrations in the monitoring data ranged
from 0 to 0.1 ppb; the reported data represent values for the limits of detection in most cases.

       The risk of contaminating surface or ground water by diclofop-methyl was evaluated by
assessing the estimated environmental concentrations (EEC) for both surface and ground water for
                                             20

-------
parent diclofop-methyl (and its acid degradate) and the potential maximum population exposed through
drinking water.  The Agency considered the existing STORET monitoring data and a small scale
prospective groundwater study (MRID 44532501) to characterize the potential for diclofop-methyl to
contaminate ground water sources of drinking water. EEC's of diclofop-methyl in drinking water were
calculated using PRZM/EXAMS (Tier 2 surface water) and SCI-GROW2 (Tier 1 groundwater).
Because of the lack of adequate monitoring data from across the country, the Agency has conducted a
surface water analysis and a Tier 1 groundwater analysis for diclofop-methyl using computer modeling.

        Diclofop-methyl is not expected to reach ground or surface water in significant quantities under
most conditions. If it were to reach surface water, it is expected to degrade rapidly by microbial
metabolism. If diclofop-methyl were to reach ground water, it could possibly persist due to potentially
low microbial activity. Biodegradation is the only apparent means of diclofop-methyl dissipation.
Parent diclofop-methyl degrades rapidly in aerobic soil (Tm * 1 day) to its acid metabolite, diclofop
acid. Diclofop-methyl and its acid metabolite degraded with an estimated half life of 21 to 51.3 days in
four aerobically incubated soils.  Under anaerobic conditions, diclofop-methyl also degrades rapidly to
diclofop acid. Diclofop acid was persistent under anaerobic conditions with a half life of greater than
60 days. Under almost all conditions, degradation is expected to be so rapid that diclofop-methyl will
not have time to move in soil. Its low solubility in water (3 mg/L) also causes it to be less mobile in soil.

        The residues of concern for drinking water are diclofop-methyl and its degradate, diclofop acid.
PRZM/EXAMS and SCI-GROW modeling estimates, as well as monitoring data from the prospective
groundwater study, include both the parent diclofop-methyl and its acid degradate. For the purposes of
this risk assessment, the Agency assumes that the degradate is as toxic as the parent.  The models were
run assuming the parameters (i.e., application rate, frequency of application, etc.) associated with
diclofop-methyl use on wheat and barley.
                      a.
                             Surface Water
        The Agency considered the existing STORET surface water monitoring data but decided the
 data were not suitable for predicting a drinking water estimate. Because the data values were all below
 the limit of detection (<0.1 ppb), the Agency decided that surface water modeling would provide more
 appropriate values for drinking water risk calculations.

        For drinking water derived from surface water bodies, an acute concentration of 1.47 ppb was
 used to evaluate the risk to human health. This value is based on the maximum (upper 90th) percentile
 concentration calculated using PRZM-EXAMS. A chronic value of 0.097 ppb was used to evaluate
 the chronic and cancer risk to human health. This value is based on the 10 year annual mean
 concentration calculated using PRZM-EXAMS.
                                              21

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                      b.
Ground Water
        For drinking water derived from groundwater, a value of 0.067 ppb was used to evaluate
 acute, chronic, and cancer risks to human health.  This value is based on the SCI-GROW2 model and
 assumes one application per season of 1 Ib ai/acre.

        A small scale prospective groundwater study found lhat diclofop-methyl does not leach to
 groundwater. In this study at 48 days after treatment, researchers detected bromide tracers in the
 shallow groundwater wells, indicating recharge of aquifer, yet neither diclofop-methyl nor its acid
 metabolites were detected in groundwater or soil water samples.

        Because the predicted concentration (0.067 ppb) of diclofop-methyl in groundwater is below
 the limit of quantitation (1 ppb) from the prospective groundwater study, the Agency cannot predict
 with certainty whether diclofop-methyl will or will not reach groundwater at some level between 0 and
 1 ppb. However, when taking all available information into consideration, particularly the environmental
 fate properties, the results  of the prospective groundwater study, and the limited STORET ground
 water monitoring data, the Agency concludes that neither diclofop-methyl nor its acid metabolite are
 expected to reach groundwater. Nonetheless, the Agency used the modeled estimates to quantify
 exposure to potential diclofop-methyl residues in drinking water.

                     c.       Drinking Water Levels of Comparison (DWLOC's)

        To determine the maximum allowable contribution of pesticide residues from drinking water in
 the diet, EPA first looks at how much of the overall risk is contributed by food (and if appropriate,
 residential uses or other non-occupational sources of exposures), and then calculates a "drinking water
 level of comparison" (DWLOC) to determine whether modeled values exceed this level. The Agency
 uses the DWLOC as a surrogate to capture risk associated with exposure from pesticides in drinking
 water. The DWLOC is the maximum concentration in drinking water which, when considered together
 with dietary (food) exposure, does not exceed a level of concern. Acute exposure to residues of
 diclofop-methyl is considered to be exposure in a one-day time period via the oral route of exposure
 (i.e, through food and/or drinking water only).

        The results of the Agency's drinking water analysis for acute (one-day), short-term, and
 chronic  (lifetime) exposure are summarized below.  Details of this analysis, which used screening
models, actual monitoring  data, and a small scale prospective ground water study are found in the HED
Revised Human Health Risk Assessment, dated August 10,2000.

                            i.      DWLOC's for Acute Exposure

       For acute risk, the  potential drinking water exposure derived from either ground or surface
water is not of concern. The DWLOC for the sub-population of females aged 13 to 50 is 3000 ppb.

                                            22

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Because the EEC is less than the DWLOC, the Agency has no concern for acute exposure to diclofop
residues in water. The table below presents the values for the acute drinking water assessment

Table 4. Summary of DWLOC Values for Acute Dietary Risk


Population',
Subgroup
Females
13-50


.Acute PAD
(mg/kg/day)
0.1

*

Food Exposure
>g/kg/dayX
0.007558


Allowable "*
<- Water"
4 Exposure
(njg/kg/day)
0.092442

•< Ground

Water
(nnb)
WrHJ
(SCI-
GRQW) >
0.067

V~ 	 ,;
^
Surface Water -
(PRZM-EXAMS)
1.47

,

DWLOC -
)
3000

                            ii.     DWLOC's for Short-Term Exposure

       For short-term risk, the potential drinking water exposure derived from either ground or surface
water is not of concern. Since the EECs are less than the DWLOC's for short-term exposure for all
population subgroups (refer to Table 5), the Agency has no concern for short-term exposure to
residues of diclofop-methyl in drinking water. Short-term risk applies only to a golfer who receives a
combined exposure from dietary and non-occupational (i.e., golfing on a treated course) sources.

TableS. Summary of DWLOC Values for Short-Term Dietary Risk
" < -
Population
Subgroup
.

U.S. Population
Children (1-6)
Females (13-50)
Surface
- Water _
fcpb) .
(PRZM- ,
EXAMS)'
0.097
0.097
0.097
Ground'"'
Water
- 
-------
 Table 6. Summary of DWLOC Values for Chronic (Non-Cancer) Risk
Population
Subgroup
U.S. Population
Children 1-6
Females 13-50
Chronic PAD
(mg/kg/day)
0.0023
0.0023
0.0023
Food
Exposure
(mg/kg/day)
0.000005
0.000016
0.000003
Allowable
Water
Exposure
(mg/kg/day)
0.002295
0.002284
0.002297
Ground-
Water

-------
has not completed this policy so the quantitative risk values for diclofop-methyl have not been
calculated for younger children.

       The following assumptions were used in estimating non-occupational post-application exposure
to golfers on the day of application:

       1)     Dislodgeable foliar residue (DFR) values are assumed to be five percent (5%) of the
              application rate at day zero for turf-grass application, and transfer coefficients are
              assumed to be 500 cnf/hour,

       2)     Continuous exposure is assumed to occur for 4 hours per day (assuming the entire 18-
              hole course is treated);

       3)     Average adult body weight is 70 kg;

       4)     Estimated exposure frequency to the highest residue level is 2 days/year (based on the
              assumption that a golfer would play up to four times on a course where diclofop-methyl
              is used, two times of which were on the day of treatment), and

       5)     Exposure duration is 50 years; and lifetime is assumed to be 70 years.

                             i.      Non-Cancer Risk

       Non-cancer risk estimates (a short-term scenario) for diclofop-methyl indicate that entry by
golfers is not of concern on the day of application, as soon as the spray is dry. The Agency evaluated
the non-occupational post application (golfer) non-cancer risk at both the 1 Ib ai/A and at the 1.5 Ib
ai/A rate even though the registrant is not supporting use at this higher rate. The resulting MOE for this
scenario is 310 at the typical application rate of 1.0 Ibs. ai/A. This MOE is therefore not of concern to
the Agency.
                             11.
                                    Cancer Risk
        The cancer risk for non-occupational exposure on a treated golf course (on the day of
 application) is 2.2 x 10"6. Such long-term exposure assessments are conventionally based on the
 typical rate, which in this case is 1.0 Ibs ai/A. The Agency is relying upon the supported, typical rate of
 1 Ib ai/A as the appropriate rate for assessing the post application non-occupational (golfer) cancer
 risk. For non-occupational exposure to a pesticide, the Agency considers a cancer risk probability of
 10"6 or less to be negligible.

        As mentioned above, the assumptions used in the cancer assessment for golfers are based on
 surrogate data and factors related to the behavior and environmental fate of the chemical in the

                                              25

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 environment (e.g., dissipation of transferable residues).  Due to a lack of chemical specific exposure
 data, and better information on actual use practices and golfer behavior, assumptions used to calculate
 post-application risks (e.g., hours exposure per day) are based on the professional judgement of
 Agency scientists and tend to be conservative.

              5.     Aggregate Risk

       An aggregate risk assessment considers the combined risk from dietary exposure (food and
 drinking water) and residential risk or other non-occupational exposures, when appropriate. In this
 case, the Agency evaluated four types of aggregate exposures. Results of the aggregate risk
 assessment are summarized here, and are discussed extensively in the "Revised HED Chapter of the
 Reregistration Eligibility Decision Document" This document is available on the Agency's web page at
 www.epa.gov/pesticides/ diclofop-methyl and in the Public Docket

       The Food Quality Protection Act amendments to the Federal Food, Drug, and Cosmetic Act
 (FFDCA, Section 408(b)(2)(A)(ii)) require that for establishing a pesticide tolerance "that there is
 reasonable certainty that no harm will result from aggregate exposure to pesticide chemical residue,
 including all anticipated dietary exposures and other exposures for which there are reliable information."
 Aggregate exposure will typically include exposures from food, drinking water, and residential uses of a
 pesticide, and other non-occupational sources of exposure. When appropriate, aggregate risk
 assessments are conducted for acute (one day), short-term (one to seven days), intermediate-term
 (seven days to several months), and chronic (lifetime) exposure.  Occupational exposure is not
 considered in any aggregate exposure assessment.

                     a.     Acute Aggregate Risk

       The acute aggregate risk estimate for diclofop-methyl addresses exposure from food and
 drinking water. Acute exposure is considered to occur in a one-day time frame via the oral route of
 exposure (i.e. through food and drinking water).  Acute dietary food risk for females 13-50 is below the
Agency's level of concern (<100% aPAD). The estimated concentrations of diclofop-methyl in
 groundwater and surface water are below the Agency's level of concern for exposure to  diclofop-methyl
in drinking water as a contribution to acute aggregate risk.

       Based on the available information, the Agency  concludes that residues of diclofop-methyl in
 drinking water (when considered along with exposures from food uses) would not result in an acute
aggregate human health risk of concern.

                     b.     Short-Term Aggregate Risk

       A short-term aggregate risk assessment considers exposure from food, water, and non-
occupational sources of exposure to a pesticide for a period of 1 to 7 days. For diclofop-methyl,

                                             26

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dermal short-term exposure is likely to golfers who play on a course that has been treated within a few
hours of use. At the registrant supported rate for use on golf courses, 1 Ib ai/A, the MOE is 310 for
non-occupational exposure.

       Calculated short-term DWLOCs do not exceed the Agency's level of concern as a contribution
to short-term aggregate exposure. The DWLOC for the most highly exposed sub-population, children
1-6 years old, is 100 ppb and the EEC is 0.097 ppb. Based on these estimates, the Agency concludes
that residues of diclofop-methyl in drinking water when considered along with exposures from food uses
and the short-term non-occupational exposure to golfers, would not result in a short-term aggregate
human health risk of concern.

                      c.      Chronic (Non-Cancer) Aggregate Risk

       The chronic (non-cancer) aggregate risk estimate for diclofop-methyl addresses exposure from
food, drinking water, and non-occupational sources of exposure.  No chronic residential scenarios were
identified for diclofop-methyl.. Risk to golfers is a non-occupational source of potential exposure,
however, golfers are only assumed to be exposed to the highest residues of diclofop for two days per
year. Golfers were, therefore, included only in the short-term assessment (1-7 days). For this reason,
the chronic aggregate exposure assessment addresses exposure from food and drinking water only.

       Chronic dietary food risks are below the Agency's level of concern (<100% cPAD) for all
population subgroups.  The estimated concentration of diclofop-methyl in groundwater and surface
water is below the Agency's level of concern for exposure to diclofop-methyl in drinking water as a
contribution to chronic aggregate risk Based on available information, the Agency concludes that
residues of diclofop-methyl in drinking water (when considered along with exposures from food uses)
would not result in a chronic aggregate human health risk estimate of concern.

                      d.     Cancer Aggregate Risk

       The cancer aggregate risk estimate to diclofop-methyl addresses carcinogenic (lifetime)
exposure from food, drinking water, and residential sources of exposure (in the case of diclofop-methyl,
long-term exposure to golfers).  For the general population, the Agency does not believe that exposure
to residues of diclofop-methyl in food and drinking water will significantly contribute to aggregate cancer
risk.

       The carcinogenic exposure to golfers (2.2 x 10'6) is of concern; therefore, any aggregation of
carcinogenic exposure to golfers with carcinogenic exposure from food and drinking water will only
increase the risk further above the Agency's level of concern. However, as previously mentioned, the
Agency believes that the cancer risk estimate for golfers is based on conservative assumptions and
overestimates risk.
                                             27

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               4.      Occupational Risk

       Occupational workers can be exposed to a pesticide through mixing, loading, and/or application,
or re-entering treated sites. Occupational handlers of diclofop-methyl include: individual farmers or
growers who mix, load, and/or apply pesticides, professional or custom agricultural applicators, and golf
course management professionals. Risk for all of these potentially exposed populations is measured by a
MOE, which determines how close the occupational exposure comes to a NOAEL. Generally, MOEs
greater than 100 are not of concern.  In certain cases, the Agency also calculated a lifetime cancer risk

                      a.     Toxicity

       By the oral route of exposure, diclofop-methyl is a toxicily category II and by the dermal route,
it is placed in acute Toxicity Category IE.  Diclofop-methyl is placed in toxicity category IV via the
inhalation route. Regarding the eye irritation potential of diclofop-methyl, test results place it in Toxicity
Category ffl. In primary irritation studies, diclofop-methyl produced moderate eye irritation (toxicity
category HI) and slight dermal irritation (toxicity category IV).  Refer to Table 7b below for a summary
of the acute toxicily of diclofop-methyl.

Table 7b. Acute Toxicity Profile
Study Type
81-1(870.1100): Acute Oral
(LD30)
81-2(870.1200): Acute Dermal
(LD30)
81-3 (870.1300): Acute
Inhalation (LC;0)
81-4(870.2400): Primary Eye
Irritation
81-5 (870.2500): Primary
Dermal Irritation
81-6 (870.2600): Dermal
Sensitization
Animal
Rat
Rat
Rat
Rabbit
Rabbit
Guinea
Pig
Resu Its r- Category Basis - -
Combined LD50=512 (428-636) mg/kg
Male and Female LD50 > 2000 mg/kg
Male and female LC50> 3.83 mg/L
Slight ocular irritant, Conjunctival
redness and discharge at 24 hr, clean
by 72hr
Slight irritant, PII = 0.8 (0 to 72 hr)
Buehler: Negative
Maximization: Moderate to severe
sensitizer
Toxicity Cat
II
III
IV
d III
IV
NA
NA
MRJD Nq."v ; /
41476001
92036052
00071522
92036013
00032595
42428601
40213506
41476003
92036047
41476002
41476003
92036046
       All occupational risk calculations are based on the most current toxicity information available for
diclofop-methyl, including a 21-day dermal toxicily study in the rat. The uncertainty factor (UF) of 100
was applied to the risk assessment: 10X to account for interspecies extrapolation and 10X to account
for intraspecies variability.
                                              28

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       The short- and intermediate-term dermal NOAEL of 5 mg/kg/day is derived from a 21-day
dermal toxicity study in the rat, and is based on increased liver enzymes, proteins, and absolute and
relative liver weights at the LOAEL of 25 mg/kg/day. Diclofop-methyl is not expected to be used on a
continuous long-term basis (i.e., greater than six months per year) resulting in chronic exposure to
workers or handlers. Therefore, the Agency only conducted short-, intermediate-term, and cancer
occupational risk assessments.

       A dermal absorption factor (after 10 hours of exposure) of 15% is used to convert the dermal
dose to an equivalent oral dose for the cancer risk assessment only.  This factor is based on the results
from the dermal absorption study, which measured two formulations of diclofop-methyl (Hoelon SEW
and SEC).

       The subchronic feeding study in the rat is appropriate for short- and intermediate-term inhalation
risk assessment since the effect (liver toxicity) is consistent with the other studies in both rats and mice.
The current use pattern for diclofop-methyl does not indicate a concern for long-term inhalation or
dermal exposure. The toxicological endpoints, and other factors used in the occupational and residential
risk assessments for diclofop-methyl are listed below.

Table 7a. Summary of Toxicological Endpoints and Other Factors Used in the Human
Occupational Risk Assessments for Diclofop-Methyl
Assessment
Short-Term and
Intermediate-
Dermal
Inhalation (Short-
and Intermediate-
Term)
Long-term Non-
cancer(Dermaland
Inhalation)
Cancer
(Dermal and
Inhalation)
Dose
NOAEL=5mg/kg/day
QralNOAEL=1.6
mg/kg/day
* <• Endpoint
Increased liver enzymes,
proteins, and absolute and
relative liver weights
Based on increased liver
en2ymes,proteins,andabsolute
and relative liver weights.
100% inhalation is assumed
- Study
21-Day Dermal Toxicity
Study in the Rat
(MRID 41476004)
Sub-Chronic Oral Toxicity
Study in the Rat
(MRID 42573301)
Based on the use pattern, this risk assessment was not conducted
Q,* of 2.3x 10-'
(mg/kg/day)7
Based on Liver adenomas and
carcinomas withsignificanttrend
and pair-wise comparisons.
Mouse Carcinogenicity
Study
(MRID 92036058)
UF*
100
100
N/A
100
* UF includes a 10X for interspecies variability and a 10X for intraspecies variability.

                     b.     Occupational Risk Assessment Exposure Assumptions

                            i.      Occupational Handler Risks

       Anticipated use patterns, application methods, and application rates were derived from current
end use product labeling. Application rates specified on diclofop-methyl labels range from 1 Ib ai/A in
                                             29

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agricultural settings to 1.5 Ib ai/A on golf course turf.  The registrant is only supporting the 1.0 Ib ai/A for
golf course turf.  However, the risk assessment considered the higher rate on golf courses for some
assessments.

       Occupational handler exposure assessments are conducted by the Agency using different levels
of personal protective. The Agency typically evaluates all exposures with minimal protection and then
adds additional protective measures using a tiered approach to obtain an MOE or cancer risk (i.e., going
from minimal to maximum levels of protection) that is no longer of concern to the Agency. The lowest
level of personal protective equipment (PPE) is baseline PPE. If required (i.e., MOEs are less than
100), increasing levels of risk mitigation PPE are applied. If MOEs are still less than 100, engineering
controls (EC) are applied. In some cases, EPA will conduct an assessment using PPE or ECs taken
from a current label. The levels of protection that formed the basis for calculations of exposure from
diclofop-methyl activities include:
       Baseline:
       Minimum PPE:
       Maximum PPE:
                             Long-sleeved shirt and long pants, shoes and socks.
                             Baseline + chemical resistant gloves and a respirator.
                             Coveralls over long-sleeved shirt and long pants, chemical     resistant
                             gloves, chemical resistant footwear plus socks, chemical resistant
                             headgear for overhead exposures, and a respirator if risk is driven by
                             inhalation.
•      Engineering controls: Engineering controls such as a closed cab tractor for application
       scenarios, or a closed mixing/loading system, such as a closed mechanical transfer system for
       liquids or a packaged based system (e.g., Lock-N-Load for granulars or water soluble
       packaging for wettable powders).

       The Agency has determined that occupational exposure to diclofop-methyl residues via the
dermal and inhalation routes of exposure may occur during mixing, loading, applying, and other handler-
use activities. Based on registered use patterns, seven major exposure scenarios have been identified for
diclofop-methyl:

       (1) mixing/loading liquids for groundboom application;
       (2) mixing/loading liquids for aerial application;
       (3) mixing/loading liquids for hand gun sprayer application;
       (4) applying liquids with a groundboom sprayer,
       (5) applying liquids with a fixed-wing aircraft;
       (6) applying liquids with a hand gun sprayer; and
       (7) flagging for liquid applications.

       The exposure scenarios are of short-term (1-7 days) and intermediate-term (one week to
several months) duration only.  No chronic occupational handler exposure scenarios have been identified
for diclofop-methyl. However, the Agency also evaluated the cancer risk for handlers of diclofop-
                                              30

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methyl. The estimated exposures consider baseline protection (long pants; long sleeved shirt; no gloves;
open mixing/loading; and open cab tractor), additional PPE (double layer of clothing; chemical resistant
gloves; and a dust mist respirator), and engineering controls (closed mixing/loading; enclosed cab,
cockpit, and truck; and water soluble packaging).

       Chemical-specific exposure data for assessing human exposures during pesticide handling
activities were not submitted to the Agency in the support of the reregistration of diclofop-methyl. It is
Agency policy to use data from the Pesticide Handlers Exposure Database (PHED) Version 1.1 to
assess handler exposures for regulatory actions when chemical specific monitoring data are not available.
PHED is a software system consisting of two parts — a database of measured exposure values for
workers involved in the handling of pesticides under actual field conditions and a set of computer
algorithms used to subset and statistically summarize the selected data. Currently, the database contains
values for over 1,700 monitored individuals (i.e., replicates).  While data from PHED provide the best
available information on handler exposures, it should be noted that some aspects of the included studies
(e.g., duration, acres treated, pounds of active ingredient handled) may not accurately represent labeled
uses in all cases.

       General assumptions used in the occupational handler exposure assessment include an average
body weight of an adult handler as 70 kg and an average work day interval of eight hours.  Each
exposure scenario includes the allowable maximum application rate that was identified on available
product labels. In addition, a range of application rates was used for golf courses. The daily acres
treated are Agency standard values; deviations from Agency standard values include the use of 40 acres
per day for groundboom application to golf courses.  The Agency believes that most users of diclofop-
methyl on golf courses are handlers employed by the golf course rather than professional or custom
applicators. Such users typically only spot treat about 5 acres at a time, rarely treating the whole golf
course. Nonetheless, the Agency assumed handlers would treat the entire course because the label does
not limit the user from treating an entire golf course (which is assumed to be 40 acres).  Also, the
Agency typically uses a value of 1,200 acres for aerial treatment to wheat and barley.  In the case of
diclofop-methyl, the Agency has determined that 350 acres is more representative of current diclofop
use practices.  Therefore, risk to workers who handle diclofop-methyl supporting aerial applications was
assessed at 350 acres per day.

       Several issues should be considered when interpreting the occupational exposure risk
assessment. These include: the quality of the PHED data set; the use of several  generic protection
factors for calculating handler exposures (e.g., 80 percent protection factor over baseline for inhalation
unit exposure to account for the use of a dust/mist respirator); and the use of standard assumptions (e.g.,
acres treated per day, square feet applied, and gallons of liquid applied) that are based on the Agency's
best professional judgement. Estimates of acres treated per day were provided by the registrant and,
while the registrant's estimates are generally lower than Agency estimates, the magnitude of the
differences are not considered sufficient to significantiy impact the results of the assessment
                                              31

-------
       The PHED task force has evaluated all data within the system and developed a set of grading
criteria to characterize the quality of the original study. Mixing/loading/applying liquids by groundboom
scenario has a high quality grade; mixing/loading liquid for a hand gun sprayer has a high quality grade;
applying liquid with a hand gun sprayer has a low quality grade; mixing/loading liquid for fixed-wing
aircraft has a high quality grade; applying with a fixed wing aircraft has a low.quality grade; and flagging
for liquid application has a high quality grade.
                             11.
Non-Cancer Handler Risk
       Dermal and inhalation NOAELs for diclofop-methyl were based on a common endpoint;
therefore, the dermal and inhalation MOEs were combined to determine a total short-term MOE and a
total intermediate-term MOE. Short-term MOEs represent exposure scenarios that are one to seven
days in duration. Intermediate-term MOEs represent exposure scenarios that are one week to several
months in duration. A MOE greater than or equal to 100 is not of concern.
                             m.
                                    Cancer Handler Risk
       General assumptions used in the occupational cancer risk assessment include an average body
weight of 70 kg, a career duration of 35 years which represents a typical working lifetime, a lifetime of
70 years, 15% dermal absorption and 100% inhalation absorption, a Qj* of 2.3 x 10"1 (mg/kg/day)'1,
and PPE (baseline plus coveralls and a dust/mist respirator). Two exposure frequency scenarios were
used for wheat and barley in the calculations: the first represents the maximum number of applications
per site per year for private use (10 days), and the second represents commercial handlers making
multiple applications per site per year (20 days).  For golf courses, an exposure frequency of 10 days
per year is assumed.

        The cancer risk assessment for handlers uses a baseline exposure scenario and, as needed,
increasing levels of risk mitigation (PPE and engineering controls) to achieve cancer risks that are not of
concern. The Agency's goal is to mitigate occupational cancer risk estimates to 1 x 10"6 or less. For
diclofop-methyl, cancer risk for occupational dermal and inhalation exposure range from 1.4x10"2 to
5.1x1 Q-6 at the baseline level, 8.4x10's to 6.0xlO'7 with PPE, and 5.8x10'5 to 1.4x10'6 at the engineering
control level.
                                              32

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              5.      Occupational Post-Application

       The post-application occupational risk assessment considered exposures to workers entering
treated sites in agriculture as well as exposures that can occur as a result of turf management activities
on golf courses. The Agency has determined that there are potential post-application exposures to
occupational workers in the following scenarios: mowing/maintaining golf course turfgrass; and scouting
of wheat and barley fields.  Because harvesting wheat and barley is fully mechanized, there is low
potential for post-application exposure. Therefore, a quantitative risk assessment was not conducted
for this scenario. Fully mechanized is defined as activities that eliminate the potential for pesticide
exposure by physically  separating the worker from anything that has been treated with the pesticide to
which the restricted-entry interval applies. This includes, but is not limited to, soil, water, air, or
surfaces of plants.  These mechanized processes must meet the criteria described in the Worker
Protection Standard for  entry during a restricted entry interval (REI) for activities with "no contact."
The current REI for diclofop-methyl is 24 hours.

       No chemical specific post-application exposure studies were conducted by the registrant.
Therefore, post-application exposures to occupational workers were estimated using assumptions for a
surrogate post-application assessment presented in the Standard Operating Procedures (SOPs) for
Residential Exposure Assessments (12/18/97). These data were used in conjunction with Agency
standard values for transfer coefficients to assess potential exposures to workers reentering treated
sites.

       The following assumptions were used in the calculations of occupational post-application risk:
dislodgeable foliar residue (DFR) values are assumed to be five percent of the application rate at day
zero for turfgrass application; transfer coefficients are assumed to be 500 crrf/hour for mowing and
maintaining golf course turf and 1000 cnf/hour for scouting of wheat and barley; daily exposure is
assumed to occur for eight hours per day for mowing and maintaining golf course turf and scouting
wheat and barley; the average adult body weight is assumed to be 70 kg; exposure frequency is
assumed to be four days/year for golf course mowing and 10 days/year for wheat and barley scouting
(based on best professional judgement); exposure duration is assumed to be 35 years (a typical
working lifetime); and lifetime is assumed to be 70 years.

                      a.      Occupational Non-Cancer Post-Application Risk

       Entry by golf course workers to mow and maintain golf course turf is acceptable on the day of
application, as soon as the spray is dry.  MOEs are based on a dermal NOAEL of
5 mg/kg/day. The MOEs for this scenario are 155 for workers who mow and/or maintain golf course
turf at the 1.0 Ibs ai/A rate and 105 for these workers at the higher, spot application rate of 1.5 Ibs ai/A
(this latter rate is not supported by the registrant). The MOE for the scout who reenters a wheat or
                                             34

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barley field is 195 at the typical application rate of 1.0 Ib ai/A. A MOE greater IhanlOO is not of
concern.

                      b.     Occupational Cancer Post-Application Risk

       The calculation of cancer risk for workers scouting in treated wheat and barley fields is 2.3x10"
5 on the day of application. The Agency estimated the cancer risk for workers who mow and maintain
golf courses to be 6.1xlO~6, at the typical rate of 1.0 Ibs ai/A.  The Agency is relying upon the
supported, typical rate of 1 Ib ai/A as the appropriate use rate for assessing the occupational post
application cancer risk on golf courses.

       D.     Environmental Risk Assessment

       A summary of the Agency's environmental risk assessment is presented below. For detailed
discussions of all aspects of the environmental risk assessment, see the Environmental Fate and Effects
Division chapter, dated July 26,2000 available in the public docket or at
www.epa.gov/pesticides/reregistration/diclofop-methyl.

       The Agency's ecological risk assessment compares toxicity endpoints from ecological toxicity
studies to estimated environmental concentrations based on environmental fate characteristics, pesticide
use, and/or monitoring data. To evaluate the potential risk to nontarget organisms from the use of
diclofop-methyl products, EPA calculates a Risk Quotient (RQ), which is the ratio of the estimated
exposure concentration to the toxicity endpoint values, such as LD50 (the median lethal dose at which
50% of the test animals die) or LC50 (the median concentration of a substance which causes death to
50% of the test animals).  The RQ, a non-probabilistic expression of risk, is simply a means  of
integrating the results of ecological exposure and ecological toxicity. These RQ values are compared to
levels of concern (LOCs), which provide an indication of the risk that a particular pesticide and/or use
may pose for nontarget organisms. If the RQ does not exceed the LOG, it is unlikely that the pesticide
will pose a significant risk. Similarly, when RQs are equal to or greater than the LOG, additional
refinements or mitigation are usually undertaken. Use, toxicity, fate, and exposure are considered to
characterize the risk as well as the level of certainty and uncertainty in the assessment

       Terrestrial and aquatic risks were assessed for a single broadcast application of diclofop-methyl
at the rate of 1 Ib ai/A.  Risk to terrestrial organisms were also assessed for multiple spot-treatment
applications. For spot treatments, the maximum application rate for spot treatments is 1.0 fl oz per
1000 ft2, or approximately 1.0 Ib ai/A, the same as for broadcast applications. The maximum per
season or annual rate for spot treatment is 1.5 fl oz per 1000 ft2, or 1.53 Ib ai/A. Therefore, to assess
the worst case use pattern, the assessment was based on a single application at 1.0 Ib ai/A followed by
a second application of 0.53 Ib ai/A. The application interval was assumed to be 7 days. Risk to
aquatic organisms was not assessed for repeated spot-treatment applications because there were no
risks identified for a single broadcast application. For aquatic exposure, the single broadcast
                                             35

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 application represents the worst-case use pattern because of significantly higher quantity of application
 and the area treated as compared to spot treatments.

               1.     Environmental Fate and Transport

        Biodegradation is the predominant means of dissipation of diclofop-methyl.  Parent diclofop-
 methyl rapidly degrades in aerobic soil (Tl/2 <. 1 day) to its acid metabolite, diclofop acid.  Diclofop-
 methyl and its acid metabolite degraded with an estimated half life of 21 to 51.3 days in four aerobically
 incubated soils. Under anaerobic conditions diclofop-methyl degraded rapidly to diclofop acid. The
 diclofop-acid was extremely persistent under anaerobic conditions with a half life of greater than 60
 days. Under almost all uses, the degradation is expected to be so rapid that diclofop-methyl will not
 have time to move in soil.  Its low solubility in water (0.8 mg/L at pH 7.0) also causes it to be immobile.
        Diclofop-methyl is stable to hydrolysis at pH 5 with a reported half-life of 363 days.  Under
alkaline conditions diclofop-methyl is unstable with a half-life of 12.5 hours at pH 9. In pH 7 buffer
solution, diclofop-methyl is moderately stable with a half-life of approximately 32 days. Diclofop acid
was the only degradate detected in any of the solutions, and it did not undergo any further hydrolytic
degradation at any pH in a study performed at 25° C. (MRID 41573309)

        In another hydrolysis study (Ace. No. 244-465) performed at 21° C, it was demonstrated that
diclofop-methyl hydrolyzed rapidly at pH 9 with a half-life of 1.85 days, slowly at pH 7 with a half-life
of 21.4 days, and at pH 5 the half-life was 2650 days.  Diclofop acid was the only degradate detected
in any of the solutions, and it did not undergo any further hydrolytic degradation at any pH.

        Diclofop-methyl plus diclofop acid, the primary degradate, degraded with estimated half-lives
of 21 to 51.3 days in four aerobically incubated soils. Parent diclofop-methyl was rapidly degraded to
diclofop acid.  Except for the sterilized soils, all the parent had been degraded by the 4th day of
sampling to mainly diclofop acid. The concentration of the primary degradate reached it highest
concentration at 1 or 2 days (77.7% of applied radioactivity, 1.17 ppm) and then decreased to an
average 13.1% (0.2 ppm) of the applied radioactivity after 100 days of incubation. Diclofop acid
degraded to diclofop phenol (4-(2,4-dichloro phenoxy)-phenol, but never was greater than 4% of
applied radioactivity (0.06 ppm). Extractable residues accounted for  14-40% of the applied
radioactivity by the termination of the study; while bound residues were 25-42% of applied
radioactivity. (MRID 41573311).

        To better understand the environmental fate and transport of diclofop-methyl and its free acid
metabolite in soil, soil water, and groundwater, a small scale prospective groundwater (PGW) study
was undertaken by the registrant in Minnesota (MRID 44532501).  The study site selected represented
wheat production in a cold climate where diclofop-methyl usage is relatively high.  Study results up to 2
years after the initial application of diclofop-methyl show that no residues leached into ground water.

                                              36

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 Based upon the modeling, monitoring, and the PGW study, diclofop-methyl is not expected to reach
 either ground water or surface water in significant quantities.

        Diclofop-methyl is not persistent in soil under aerobic conditions (T < 1 day) and has very low
 persistence in anaerobic soil or water. The residues that do reach surface waters will likely be rapidly
 degraded by microbial metabolism. The results of the PGW study indicated that neither diclofop-
 methyl or its acid degradate migrated to the ground water during the two- plus- year study in a worst
 case scenario application.

              2.      Risk to Bird and Mammal Species

                      a.      Acute Risk To Birds

        Results of acute oral toxiciry testing with an upland game bird, using technical grade diclofop-
 methyl, found LD50 values  greater than 2000 mg/kg. Diclofop-methyl is practically nontoxic to avian
 species on an acute oral basis. In addition, the results of subacute dietary testing with an upland game
 bird (the northern bobwhite) and a waterfowl (the mallard) using technical grade diclofop-methyl
 yielded LC50's which exceeded 5000 ppm. Therefore, diclofop-methyl is practically nontoxic to birds
 on an acute and a subacute dietary basis.  (MRID's 40072901 and 40072902).

       For all use sites and application methods of diclofop-methyl, acute risk quotients for birds are
 less than the Agency's  level of concern. The RQs range from 0.01 to 0.03.  Because all acute RQs are
 less than the LOG for acute high risk (0.5) and risk to endangered species (0.1), all uses of diclofop-
 methyl are predicted to pose no risk to birds on an acute basis.  The Agency, therefore, has no concern
 for acute and subacute risks to birds.
                      b.
Chronic Risks To Birds
       Results of avian reproductive studies with technical grade diclofop-methyl found no significant
effect of reproduction or parental toxiciry at dietary concentrations up to 200 ppm.  The studies are
supplemental because the test levels were not high enough to determine the NOAEL and LOAEL, and
the highest test concentration was less than the maximum expected environmental concentration (EEC).
With a maximum application rate of 1 Ib ai/A, the maximum EEC is 240 ppm. Because the available
data is sufficient to conclude a low risk of chronic effects to birds, the registrant's request to waiver
new avian reproduction studies to fulfill this guideline has been approved by the Agency.

       For single broadcast applications to wheat, barley, and turf, chronic avian risk quotients for
reproductive effects range from 0.08 (seeds) to 1.2 (short grass).  Because the short grass RQ slightly
exceeds the chronic risk LOG of 1, chronic risk is not ruled out.  However, avian reproduction studies
have shown that diclofop-methyl caused no reproductive effects at 200 ppm, the highest concentration
tested, Therefore, chronic risks to bird species are probably not high, even for birds eating short grass

                                             37

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(chronic RQ of 1.66). The Agency therefore, has little concern for chronic risks to both endangered as
well as non-endangered birds.

                     c.     Acute Risks to Mammals

       Wild mammal testing is not required for diclofop-methyl because a rat toxiciry test submitted to
the Agency provided adequate information on toxicity to mammals. The geometric mean of the LD50
for male and female rats is 568 mg/kg. This indicates that diclofop-methyl is moderately toxic to small
mammals on an acute oral basis.

       A limited amount of information on the subchronic toxicity of diclofop acid, the primary
degradation product of'diclofop-methyl, is provided by a subchronic study with the rat This study
found tiaat a dietary concentration of 500 ppm of diclofop acid caused increased kidney weight in
males. The NOAEL was 100 ppm. For comparison, a 30-day feeding study with the rat testing
diclofop-methyl found increased organ weights in males at a dietary concentration of 80 ppm.  This
study did not determine the NOAEL.  These results indicate that diclofop acid is less toxic to mammals
than the parent compound, diclofop-methyl.

       For use of diclofop-methyl on wheat, barley, and turf, acute risk quotients for mammals are
below the LOG for high risk and thus do not pose a high risk to non-endangered species. For small
herbivorous mammals feeding on short grass, the RQ (0.55) slightly exceeds the high acute risk LOG
(0.5). This indicates that repeated spot applications of diclofop-methyl on turf may pose an acute risk
to small herbivorous mammals. Risk Quotients for other types of mammals are below the LOG for high
risk. Therefore, with the exception of the border-line risk finding for small herbivorous mammals, the
Agency does not have a concern for acute risks to both endangered and non-endangered mammals.
                     d.
Chronic Risks To Mammals
       Based on the results of some chronic and sub-chronic mammalian studies, the NOAEL and
LOAEL for ecologically significant effects in mammals are established at 30 ppm and 100 ppm,
respectively, based on pup mortality observed in the 3-generation reproduction test.  It is noteworthy
that a short-term (15-week) developmental study showed fetotoxic effects with an oral dose of 32
mg/kg body weight, which is approximately equivalent to an dietary dose of 640 ppm. This indicates
that short-term exposure to diclofop-methyl can impair reproduction of mammals, although somewhat
higher doses are required than for long-term exposures.

       Chronic risk quotients for mammals range from 0.50 to 8.0.  Because RQs for all food types
(with the exception of seeds) exceeds the chronic LOG (1.0), all uses of diclofop-methyl may pose
chronic risk to mammals, and may pose a risk to threatened as well as endangered mammalian species.
                                             38

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       Since the Agency's risk assessment screen indicates that there may be a chronic risk, risk could
be further evaluated and refined if additional existing fate data were provided by the registrant The
registrant has agreed to provide additional data which may support a conclusion that diclofop-methyl
has a shorter half life on foliage that is shorter than that assumed by the Agency in the risk assessment.
If the Agency confirms the shorter half-life, then the chronic risk to mammals would not be of concern.

              3.     Risk to Aquatic Animal Species

       Results of acute toxiciry testing with freshwater fish using technical grade diclofop-methyl and a
formulated product indicate that LC50 values for both a cold water test species (the rainbow trout) and
a warm water test species (the bluegill sunfish) falls in the range of 0.1 to 1 ppm. (MRIDs 41573302,
41606301, and 00098297) for the technical grade; and MRIDs 41606302 and 41606303  for
formulated product).

       A study with the rainbow trout provides information on the free acid metabolite of diclofop-
methyl. The 96-hr LC50 was determined to be 21.9 ppm. This indicates that the acid metabolite of
diclofop-methyl is less toxic to fish than the parent by almost two orders of magnitude (MRID
00098297).

       Acute and chronic RQs for fish and aquatic invertebrates range from less than 0.01 to .02. No
RQ exceeds the LOG for high risk or risk to threatened or endangered species. For both the
broadcast applications to turf and spot treatments on golf courses, the Agency is not concerned with
acute or chronic risks to freshwater or marine fish and invertebrates.

              4.     Risk To Terrestrial and Aquatic Plant Species

                     a.     Acute and Chronic Risks Non-target Terrestrial Plants

       Tier 2 terrestrial plant testing was required and submitted for diclofop-methyl because it is an
herbicide that has terrestrial non-residential outdoor use patterns, could move off the application site via
runoff and spray drift (for aerial applications), and might affect endangered or threatened plant species
associated with the application sites. The required testing consists of seedling emergence and
vegetative vigor tests with ten crop species.

       Results of tier 2 seedling emergence testing show ryegrass is the most sensitive monocotyledon
and the most sensitive species overall, with an EC25 of 0.012 Ib ai/A and an NOAEC of 0.0063 Ib
ai/A. Lettuce was the most sensitive dicotyledon. These data indicate that monocotyledons are much
more sensitive to diclofop-methyl than are dicotyledons. (MRID 41606306).

       Results of tier 2 vegetative vigor were similar to the seedling emergence test in showing that
monocotyledons are much more sensitive to diclofop-methyl than are dicotyledons.  Ryegrass is the

                                             39

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most sensitive monocotyledon and the most sensitive species overall, with an EC25 of 0.10 Ib ai/A and
anNOAEC of 0.0625 Ib ai/A. Lettuce was the most sensitive dicotyledon. (MRID 41606306).

       RQ values for the acute and chronic risks to non-target terrestrial plants range from 0.10 to
17.46. Because these RQs exceed the LOG of 1, use of diclofop-methyl on wheat, barley, and turf is
predicted to pose high risk to non-target terrestrial plants. Threatened and endangered species would
also be at risk if exposed to runoff and/or spray drift.  Risks generally stem from effects on seedling
emergence and growth from soil exposure. Effects on vegetative vigor from spray drift alone are
predicted to be minimal.

                      b.     Acute and Chronic Risks to Aquatic Plants

       Exposure to non target aquatic plants may occur through runoff and spray drift from treated
sites. No aquatic plant testing has been submitted for diclofop-methyl or diclofop acid. The test
guideline requirements (850.4400 and 850.5400) have not been fulfilled.

       In section V of this document, additional data will be required to allow the Agency to determine
risk to aquatic plants.  Because the Agency does not have data to adequately assess risk to aquatic
plants, high risk to aquatic plants is assumed.
IV.    Risk Management, Reregistration and Tolerance Reassessment Decision

       A.     Determination of Reregistration Eligibility

       Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of relevant
data concerning an active ingredient, whether or not products containing the active ingredient diclofop-
methyl 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 diclofop-methyl as an active ingredient 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 diclofop-methyl.  Appendix A lists the uses eligible for reregistration.  Appendix B identifies
the generic data requirements that the Agency reviewed as part of its determination of reregistration
eligibility of diclofop-methyl.

       These data were sufficient to allow the Agency to determine that diclofop-methyl can be used
without resulting in unreasonable adverse effects to humans and the environment. The Agency,
therefore, finds that all products containing diclofop-methyl as the active ingredient are eligible for
reregistration, provided specified changes are  made to the label. Actions needed to reregister particular
products are addressed in Section V of this document The Agency believes that these label changes
                                             40

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address the current risk estimates and reflect the use of all acceptable data available at this time
together with uncertainty factors and where data gaps exist.

       The Agency may take appropriate regulatory action if new information comes to the Agency's
attention regarding the reregistration of diclofop-methyl.  The Agency may also require the submission
of additional data (1) to support the registration of products containing diclofop-methyl, (2) if the data
requirements for registration change, or (3) if the guidelines for generating such data change.

       B.      Summary of Comments and Responses

       When making this reregistration decision, the Agency took into account comments received
during the registrant error correction and public docket phases of the RED development process. The
registrant was given 30 days to review the preliminary risk assessments for errors and the public was
also provided an opportunity to comment on the revised risk assessments. The registrant provided
general comments and technical correction type comments, most of which have been incorporated into
the revised assessments. The comments and Agency responses are available in their entirety in the
OPP public docket.

       Among the comments provided by the registrant several are noteworthy.  The registrant
commented that the endpoint based on a chronic feeding/carcinogenicity study in rats is inappropriate to
assess single exposures or intermittent exposures of less than one week to several months, when
toxicity studies of more relevant dosing duration are available. The registrant felt that the 90-day
feeding study in rats was more appropriate for the short-term inhalation risk assessment endpoint than
the chronic feeding/carcinogenicity study in rats. The Agency concurs with the registrant's basic
position and has changed the endpoint for acute and chronic intermediate-term inhalation exposure.
These endpoints are now established using a NOAEL of 1.6 mg/kg/day from a sub-chronic feeding
study in the rat

       In addition, the registrant believes that the default turf transferable residue (TTR) value of 5% of
the application rate used in the Agency's post application risk assessment should be replaced with a
TTR value of 0.30% of the application rate (Day 0) based on some of the newly submitted Outdoor
Residential Exposure Task Force (ORETF) data. In the registrant's view, the use of ORETF data in
place of the default assumptions used by the Agency would refine the golfer cancer risk to a level that is
traditionally acceptable to the Agency.

       The Agency does not believe that the 0.30% value is adequately supported by the ORETF data
in the case of diclofop-methyl, nor did ORETF develop chemical specific data for diclofop-methyl use
on golf courses to replace default values.  In the past few months, the Agency has in fact updated the
assumptions used in such risk assessments and adjusted parts of the Residential Exposure SOPs, such
as using a Turf Transferrable Residue (TTR) based on 5% of application rate on the day of application.
The former default TTR value was 20%.
                                              41

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       C.     Tolerance Reassessment

       Based on the review of the generic data for diclofop-methyl, the Agency has sufficient
information to reassess tolerances for diclofop-methyl. Specific findings are discussed in the following
section.

       D.     Regulatory Position

               1.     FQPA Assessment

                     a.     "Risk Cup" Determination

       As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with
this pesticide. EPA has determined that risk from exposure to diclofop-methyl is within its own "risk
cup." In other words, because at this time diclofop-methyl has not been found to share a common
mechanism of toxicity with other chemicals, EPA is able to conclude that the tolerances for diclofop-
methyl meet the FQPA safely standards. In reaching this determination EPA has considered the
available information on the special sensitivity of infants and children, as well as the chronic and acute
food exposure.  An aggregate assessment was conducted for exposures through food, drinking water,
and non-occupational (golfers) sources of exposure. Results of this aggregate assessment indicate that
the human health risks from these combined exposures are considered to be within acceptable levels;
that is, combined risks from all exposures to diclofop-methyl "fit" within the risk cup. Although the
aggregate assessment suggests that the combined exposure slightly exceeds the Agency's level of
concern for carcinogenic risk, the Agency concludes that such variance is within an acceptable range,
given the upper bound assumptions and variables involved in calculating exposure.
                     b.
Enforcement Method
       The current FDA enforcement method for diclofop-methyl is the Pesticide Analytical Manual
(PAM)-Volume II. This method, however, fails to detect a metabolite of concern, diclofop acid, which
is part of the tolerance expression.  In support of tolerance reassessment, the registrant developed a
new enforcement method. The new method, HRAV-14 (GLC/ECD), has been independently
validated by the registrant which successfully subjected a ruminant metabolism study to independent
laboratory validation. Based on detailed discussions with the registrant and technical supporting
evidence, the Agency expects that the HRAV-14 method will be fully validated. The reassessed
tolerances reflect this more sensitive enforcement method.

              2.     Tolerance  Summary

       Tolerances for residues of diclofop-methyl are established under 40 CFR §180.385(a). Only
tolerances for plant commodities are presently established, and none have been established for animal
                                             42

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commodities. Plant commodity tolerances are expressed in terms of the combined residues of the
herbicide diclofop-methyl [methyl-2-(4-(2,4-dichlorophenoxy)phenoxy) propanoate] and its
metabolites 2-[4-(2,4-dichlorophenoxy)phenoxy] propanoic acid and 2-[4-(2,4-dichloro-5-
hydroxyphenoxy)phenoxy] propanoic acid and its conjugates.

       The nature of the residue in plants is based on an acceptable wheat metabolism study. The
Agency reviews of the submitted study concluded that the plant residues of concern requiring regulation
should remain the parent, diclofop acid, and hydroxy diclofop and its conjugates, provided that
food/feed uses of diclofop-methyl are limited to barley and wheat.

       The nature of the residue in animals is based on an acceptable ruminant and poultry metabolism
studies. The residues of concern for both ruminants and poultry are diclofop-methyl and diclofop acid,
free and conjugated. Regulation of hydroxy diclofop in animal matrices is not necessary since its
concentration in animal tissues is relatively low.

                      a.      Tolerances To Be Listed Under 40 CFR §180.385(a)(l)

       Sufficient field residue data were submitted to reassess the established tolerances for barley
grain, barley straw, wheat grain, and wheat straw. There are no registered uses on lentils and peas, and
no registrants have committed to support diclofop-methyl uses on these crops; therefore, the
established tolerances for these crop commodities will be revoked.

       The available barley and wheat processing studies indicate that diclofop-methyl residues of
concern do not concentrate in the crop's respective processed fractions.  Therefore, tolerances are not
required for the processed fractions of barley and wheat. The Agency will further divide 40 CFR
§180.385(a) into 40 CFR §180.385(a)(l) and 40 CFR §180.385(a)(2) for separate designations of
diclofop residues of concern in plants and animals, respectively.

                      b.      Tolerances Needed  Under 40 CFR §180.385(a)(l)

       Tolerances are required and must be proposed for barley hay, wheat forage, and wheat hay.
Based on the maximum combined residues from the field trials, the Agency will establish tolerance
levels of 6.0 ppm for barley hay, 12.0 ppm for wheat forage, and 1.0 ppm for wheat hay. Adequate
aspirated wheat grain fractions (grain dust) are  available; however, based on the use pattern and
submitted residue data, a tolerance is not necessary.

                      c.      Tolerances Needed  Under 40 CFR §180.385(a)(2)

       The available ruminant feeding study suggests that tolerances should be established for the
combined residues of diclofop-methyl and diclofop acid (free and conjugated), determined as diclofop-
methyl, in milk and livestock (cattle, goats, horses, and sheep) commodities. The Agency notes that the
                                             43

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submitted ruminant feeding study (MRID 44178001) did not consider the reasssessed tolerances for
barley hay and wheat forage when calculating ruminant dietary burdens, as such, the test animals were
dosed at levels significantly lower than the Ix, 3x, and lOx levels recommended by Agency's guidelines
(860.1480).  However, since Hie submitted study clearly demonstrates transfer of residue to livestock
commodities at all fortification levels (0.11 ppm, 0.33 ppm, and 1.1 ppm) and the highest dose (25
ppm) approximates the Ix dietary burden (29.5 ppm), the Agency used this study and determined that
livestock tolerances be determined by extrapolation to the Ix dietary burden. Based on the maximum
combined residues observed in milk and tissues of dairy cattle orally administered with the test
substance at 25.0 ppm (0.85x maximum dietary burden) and extrapolating to Ix, the Agency
recommends tolerance levels of 4.0 ppm in milk, 7.0 ppm in meat-by-products (excluding kidney),
25.0 ppm in kidney, and 1.0 ppm in meat and fat of cattle, goat, horses, and sheep.

       A feeding study on swine is not available. However, translating the residue data from the
ruminant feeding study and using the 0.09 ppm maximum theoretical dietary burden for swine, the
Agency concludes that tolerances should be established for diclofop-methyl residues in fat and meat-
by-products (mbyp) of hogs. Tolerances at the LOQ (0.05 ppm) should be established for residues in
hog fat and mbyp (excluding kidney), and a separate tolerance should be established at 0.1 ppm for
residues in hog kidney.  Tolerances are not required for the meat of hogs as residues were 
-------
If •-' t
~ Commodity ~ "^
s j, «
-Current
Tolerance
(PPM)
Tolerance
Reassessment /
(PPM)
, Commmt/CarrectCommodity
f -', ' " / *
Definition
1 Tolerances Needed Under 40 CFR §180385(a)(2):
Cattle, fat
Cattle, meat
Cattle, mbyp (excluding kidney)
Cattle, kidney
Goat, fat
Goat, meat
Goat, mbyp (excluding kidney)
Goat, kidney
Hog, fat
Hog, mbyp (excluding kidney)
Hog, kidney
Horse, fat
Horse, meat
Horse, mbyp (excluding kidney)
Horse, kidney
Milk
Sheep, fat
Sheep, meat
Sheep, mbyp (excluding kidney)
Sheep, kidney
None
None
None
None
None
None
1.0
1.0
7.0
25.0
1.0
1.0
7.0
25.0
0.05
0.05
0.1
1.0
1.0
7.0
25.0
4.0
1.0
1.0
7.0
25.0




















              3.     Endocrine Disrupter Effects

       EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to
determine whether certain substances (including all pesticide active and other ingredients) "may have an
effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such
endocrine effects as the Administrator may designate." Following the recommendations of its
Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined that
there was scientific bases for including, as part of the program, the androgen and thyroid hormone
systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation
that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will
use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have
                                            45

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an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and
resources allow, screening of additional hormone systems may be added to the Endocrine Disrupter
Screening Program (EDSP).

       When the appropriate screening and/or testing protocols being considered under the Agency's
EDSP have been developed, diclofop-methyl may be subjected to additional screening
and/or testing to better characterize effects related to endocrine disruption.

       E.     Human Health Risk Mitigation
              1.
Dietary Mitigation
       The following discussion addresses risk mitigation measures pertaining to dietary exposure to
residues of diclofop-methyl in food and water. Among the specific mitigation measures discussed
below, the Agency has also determined that a number of general restrictions were needed or
reaffirmed

       To address rotational crop concerns, a suitable plant-back interval (PBI) has been established
for crops commonly rotated into fields treated with diclofop-methyl.  The registrant has agreed to
establish a 30-day PBI for barley forage, lettuce, root and tuber vegetables, leafy vegetables, and small
grains rotated into diclofop-methyl treated soils.

       In addition, the existing database supports different pre-harvest intervals (PHI) for both wheat
and barley. For barley, the PHI is 66 days. For wheat, the PHI is 77 days.

       The Agency is also maintaining a grazing restriction on wheat and barley.  This will provide a
mechanism to rninimize the potential transfer of diclofop-methyl residues to meat and milk commodities
(discussed more fully in the carcinogenic dietary risk section below).  The label will specify the need for
a time dependent (28 day) grazing restriction.

                     a.     Acute Dietary (Food)

       Acute dietary exposure that is less than 100% of the aPAD does not exceed the Agency's risk
concern. The results indicate that the population subgroup of U.S. females (ages 13-50) are acutely
exposed to diclofop-methyl at 8% of the aPAD. The acute dietary risk (food) of diclofop-methyl is
below the Agency's level of concern at the 99.9th percentile.  Because no appropriate endpoint was
identified for the U.S. general population, including infants and children, diclofop-methyl does not pose
an acute dietary (food) risk to other sub-populations. No mitigation is necessary.
                                             46

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                      b.      Chronic Dietary (Food)

       The chronic dietary risk for diclofop-methyl does not exceed the Agency's level of concern
(i.e., is less than 100% of the cPAD) for all sub-populations.  The most exposed subgroup is children
(1-6 years), whose dietary exposure is less than 1% of the cPAD. Therefore, no mitigation is
necessary.

                      c.      Carcinogenic Dietary (Food)

       The upper-bound carcinogenic risk estimate for diclofop-methyl is calculated to be
1.2xlO'6, slightly exceeding the Agency's level of concern (10"6). Although the Agency has some
concern for a dietary (food) cancer risk in this range, the Agency believes the actual exposure to
residues of diclofop-methyl and the concomitant risk is less than the quantified estimate suggests for the
following reasons:

       1)     The dietary cancer risk is based on the assumption that an individual would be exposed
              to a constant carcinogenic level of diclofop-methyl residues over a lifetime, a condition
              that is not likely in this case because of declining use. Although a relatively small
              percentage of national wheat and barley crop is currently treated (estimated to be less
              than 2% of U.S. wheat and less than 1% of U.S. barley crops), the level of exposure in
              future years will probably be even lower. Overall use of diclofop-methyl is decreasing
              due to the introduction of other herbicides; the downward trend is expected to
              continue.

       2)     The greatest potential contributor to dietary risk is milk from cows as a result of
              foraging on treated wheat. Lactating cows may graze diclofop-treated wheat fields,
              transferring residues into their milk. The extent of this potential exposure is difficult to
              measure. In the preliminary assessment, sixty percent of lactating dairy cattle were
              assumed to be grazing on diclofop-methyl treated forage.  However, after reviewing
              information about dairy and wheat cultural practices, the Agency has revised this
              estimate to 15%, based on an estimate of producing dairy cattle that may be feeding on
              wheat forage, nationwide (whether or not the grower used diclofop-methyl). In
              addition, less than two percent of the U.S. wheat is treated with diclofop-methyl. For
              these reasons, the Agency has reduced its estimates of the dietary burden from milk
              containing diclofop-methyl. It is not common practice among cattle farmers who use
              diclofop-methyl to allow cattle to forage in wheat and barley fields.  According to
              expert opinion within as well as outside of the Agency, farmers inclined to allow cattle
              to graze in treated fields would not be expected to go the expense of treating a field
              with diclofop-methyl for grassy weeds which the cattle would otherwise find palatable.
                                              47

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       In addition, there are remaining uncertainties on the carcinogenic potential of diclofop-methyl
which influence the Agency's position on managing the carcinogenic dietary risk. As a peroxisome
proliferator in certain laboratory animals, diclofop-methyl's cancer classification and the appropriate
method for quantifying the cancer risk are more indefinite than the Agency would prefer. The scientific
community remains uncertain whether such a mechanism of cancer in test species is predictive of cancer
in humans. At a minimum, the Agency is mindful that absent other evidence of carcinogenicity, the
uncertainty associated with pesticides that exhibit only peroxisome proliferation in tested species, like
diclofop-methyl, bears on how the Agency chooses to regulate such pesticides.

       The Agency is, therefore, not generally concerned with the current cancer dietary risk estimate
resulting from exposure to diclofop-methyl residues in food.  However, the Agency still recognizes the
sensitivity of the dietary analysis and the enduring need for a grazing restriction in this particular case.
The Agency's diclofop-methyl findings are highly dependent upon the relatively low percentage of crop
treated and the assumption that the national trend for diclofop-methyl use is declining. If the percent of
crop treated were to increase on wheat and barley, then the dietary (food) risk would be higher and the
Agency would have a much greater concern.

       The dietary risk assessment found that the main component of the dietary exposure estimate is
diclofop-methyl residues in milk, as a result of livestock foraging and grazing in treated fields. Diclofop-
methyl shows a high ability to transfer residues to livestock animals. To minimize the potential for
livestock feeding on treated crops when residues are still present, it is necessary to maintain a grazing
restriction on the label.  The registrant has agreed to modify the current restriction on diclofop-methyl
labels to preclude grazing for 28-days post treatment. While this measure to reduce the occurrence of
residues in milk is difficult to enforce, the establishment of tolerances on meat and milk commodities is
enforceable.

                      d.      Drinking Water

       Diclofop-methyl is not expected to reach ground or surface water under most conditions.
Degradation is expected to be so rapid that diclofop-methyl will not have time to move in soil. Its low
solubility also causes it to be immobile in soil. In a controlled field experiment, diclofop-methyl was
shown not to  leach into groundwater in any appreciable quantity.

                             i.      DWLOC's for Acute Risks

       The acute DWLOC for females ages 13-50 is 3000 ppb.  Because the DWLOC exceeds the
EECs (1.47 for surface water concerns, and 0.067 for ground water concerns), acute risks for both
surface and ground water are not of concern to the Agency and therefore do not require mitigation.
                                              48

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                             II.
DWLOC's for Chronic Risks
       The chronic DWLOCs for the U.S. population (80 ppb), children 1 to 6 years of age (20 ppb),
and females 13 to 50 years of age (70 ppb), are all greater than the chronic EECs (0.097 for surface
water and 0.067 for ground water) and therefore are not of concern to the Agency. No mitigation is
required.
                             m.
DWLOC's for Cancer Risks
       As discussed previously, the Agency was unable to calculate a DWUDQ..^,. because the
DWLOC represents availability in the "risk cup." Nonetheless, based on environmental fate properties
and limited monitoring data, diclofop-methyl is not expected to reach surface and ground water in
significant quantities. The water exposure estimates are based on ecological models, which may not
reflect actual residue concentrations in drinking water. Taken together, these considerations lead the
Agency to conclude that there is not a cancer risk resulting from exposure to diclofop-methyl residues
in either surface or ground water.

              2.     Non-Occupational Risk Mitigation

                     a.     Non-Occupational Non-Cancer Risk Mitigation

       Non-cancer risk estimates for diclofop-methyl indicate that entry by golfers is not of concern on
the day of application as soon as the spray is dry. The MOE for this scenario is 310. This risk is
therefore not of concern to the Agency and does not warrant mitigation.

                     b.     Non-Occupational Cancer Risk Mitigation

       The Agency has determined that the non-occupational cancer risk to golfers is 2.2x10"6, yet has
also concluded that some of the assumptions in the assessment are conservative. For example,
diclofop-methyl is applied to less than 1% of all golf courses nationally. However, the Agency assumed
that an individual may come into contact with diclofop-methyl residues for four hours per day, two days
per year. The golfer would need to be on the course during both of those treatment days. Also, the
analysis assumes that an individual is  exposed to the highest residues for four hours per episode.
Diclofop is not usually applied to an entire golf course and is more commonly applied to five acres or
less at any given time. As a result, approximately l/8th of the course would have residues rather than
the whole course.

       As illustrated above, the Agency believes that a golfer is more likely to be exposed for much
less than 4 hours. A more realistic assumption for exposure duration is 1/2 hour per round of golf.  The
resulting cancer risk is 2.7x10'7. The Agency believes that this is a more realistic exposure scenario in
                                             49

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accordance with current use practices. Thus, the Agency is not requiring any mitigation measures for
non-occupational cancer risks.

              3.     Aggregate Risk Mitigation

                     a.     Acute Aggregate Risk Mitigation

       Based on the available information, the Agency concludes that residues of diclofop-methyl in
drinking water (when considered along with exposures from food uses) would not result in an acute
aggregate human health risk of concern.  No mitigation measures are required.

                     b.     Short-Term Aggregate Risk Mitigation

       Calculated short-term DWLOCs do not exceed the Agency's level of concern as a
contribution to short-term aggregate exposure. Based on available information, the Agency concludes
that residues of diclofop-methyl in drinking water (when considered along with exposures from food
uses and short-term non-occupational exposure) would not result in a short-term aggregate human
health risk estimate of concern. No mitigation is required.

                     c.     Chronic (Non-Cancer) Aggregate Risk Mitigation

       Chronic dietary food risks are below the Agency's level of concern (<100% cPAD) for all
population subgroups.  The estimated concentration of diclofop-methyl in groundwater and surface
water is below the Agency's level of concern for exposure to diclofop-methyl in drinking water as a
contribution to chronic aggregate risk.

       Based on the available information, the Agency concludes that residues of diclofop-methyl in
drinking water (when considered along with exposures from food uses) would not result in a chronic
aggregate human health risk estimate of concern. No mitigation is required.

                     d.     Chronic (Cancer) Aggregate Risk Mitigation

       The carcinogenic exposure to golfers (2.2 x 10~6) is of concern; therefore, any aggregation of
carcinogenic exposure to golfers with carcinogenic exposure from food and drinking water would only
increase the risk further above the Agency's level of concern. However,  for reasons mentioned earlier,
the Agency has determined that the three components of the aggregate cancer risk provide marginal
concern.  The food exposure is predicated on constant diclofop-methyl use (which the Agency believes
is declining) and a theoretical assumption on the number of diclofop-methyl growers who allow cattle to
graze in treated fields.  This assumption may not reflect actual grazing practices on diclofop-methyl
fields.
                                             50

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       Moreover, the golfer exposure component is based on high end assumptions which may
overestimate risk. The circumstances required for an individual golfer to receive such regular, lifetime
exposures to diclofop-methyl are unlikely. The drinking water exposure component is based on
modeling estimates, despite the Agency's conclusion that diclofop-methyl is not likely to be found in
drinking water. Coupling the uncertainty of golfer exposure with the combined dietary exposure from
residues in food and water in this case represents an even more unlikely event. Thus, the Agency does
not believe mitigation measures are warranted to address the aggregate cancer risk.

              4.      Occupational Risk Mitigation

                      a.      Agricultural Handler Risk Mitigation

                             i.      Handler Non-Cancer Risk Mitigation

       Total short- and intermediate-term MOEs for non-cancer handler risk are not of concern
(MOE ;> 100) at the highest level of risk mitigation (PPE or engineering controls) for all scenarios.
MOEs range from <1 to 535 at baseline; 60 to 2615 at PPE;  and 110-760 at the engineering control
level. The value used for daily acres treated (350  acres) for scenarios (2) and (5) is based on the
Agency's estimate of acreage that would be reasonably expected to be treated in a single day. Current
agronomic practices are believed to exclude whole field treatments. If farmers were treating their entire
crop with diclofop-methyl, the Agency would have used a larger acreage estimate (e.g., 1,200 acres)
except for the handler risks associated with aerial applications. The Agency is generally not concerned
with non-cancer handler risks of diclofop-methyl.  To address the aerial handler risk, the Agency finds
the use of engineering controls necessary. The registrant has agreed to implement engineering controls
to mitigate the handler risks associated with the use of diclofop-methyl.

                             ii.      Handler Cancer Risk Mitigation

       The Agency's goal is to reduce worker cancer risks to 10"6 or less, although risks somewhat
higher than 10~6 may be considered acceptable if measures to mitigate these risks are not available and
benefits of continuing use are demonstrated.  Thus, for risks that are greater than 10"6 and less than  10'
4, the Agency carefully examines risks in this range including tiie benefits of use, availability of
alternatives, number of workers at risk, and will seek ways to further mitigate these risks. Because all
of the worker scenarios described in Section III have cancer risk estimates in the range of 10"6 to 10"4,
the Agency considered whether additional worker mitigation measures were available.

       The Agency is concerned with cancer handler risks associated with the use of diclofop-methyl
on wheat and barley.  Even though the cancer handler risks associated with diclofop-methyl which
incorporate engineering controls, range from 2.6xlQ-5 (applying liquids by air) to 4.9xlO"6 (mixing and
loading for groundboom application), the risks'are higher with the use of PPE only. To minimize
handler exposure to diclofop-methyl, the registrant has agreed to modify diclofop-methyl labels for

                                             51

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wheat and barley vises to include the use of engineering controls. Although the registrant has not
specified how this is to be accomplished, the Agency has been assured by the registrant that they will
provide an equivalent protection to closed mixing/loading systems and enclosed application equipment
For the purposes of reregistration, the Agency assumes the adoption of closed mixing/loading systems
and the use of enclosed cabs/cockpits for diclofop-methyl use on barley and wheat.  Based on current
agronomic practices, the Agency anticipates that wheat and barley growers will not have significant
difficulty converting to the use of engineering controls.

                      b.      Post-Application Worker Risk Mitigation

                             i.      Workers Who Mow and Maintain Golf Courses

       The acute reentry risk for workers who mow and maintain golf courses is not of concern to the
Agency on the day of treatment after the spray is dry. Application rates specified on diclofop-methyl
labels range  from 1.0 Ib ai/A in agricultural settings to 1.5 Ib ai/A on golf course turf even though the
registrant is only supporting the 1.0 Ib ai/A for golf course turf.  The MOE is 155 at the maximum
supported application rate of 1.0 Ibs ai/A.  To ensure such workers do not reenter before the spray is
dry, the Agency will maintain the current restriction stating, "Do not enter or allow workers entry into
treated areas until spray is dry."

       The post-application chronic (cancer) risk estimate for mowers, however, is estimated to be
6-lxlO"6, which exceeds the Agency's level of concern for such workers. However this estimate may
overestimate the risk, considering current use directions. A use practice associated with diclofop-
methyl use on golf course turf effectively mitigates this cancer risk concern.  Current diclofop-methyl
products labeled for golf course turf use prescribe, for efficacy reasons, that the course not be mowed
within 36 hours of treatment  Because diclofop-methyl is a contact herbicide, users must be careful not
to mow or otherwise disturb the action of the herbicide on the target grass weeds within the first few
days of application. As a result, mowers who follow label instructions are not likely to receive the level
of exposure that the post-application cancer risk assessment predicts.  To ensure protection of
workers who mow treated golf courses, diclofop-methyl labels need to retain language that precludes
mowing within 36 hours of treatment

                             ii.     Workers Who Scout Wheat and Barley Fields

       For scouts entering a treated wheat or barley field (at the 1.0 Ib ai/A rate), the MOE is 195 and
the cancer risk is 2.3x10"5 for lifetime exposure.  While Hie former risk is not of concern, the latter
cancer risk is of concern to the Agency. Because the exposures are assumed to occur on the day of
treatment, maintaining the current REI of 24 hours will mitigate some of the potential cancer risk.
Moreover, as a practical matter, scouts are not expected to regularly reenter treated fields as early as
the REI, and when they do reenter a treated field, it is expected to be many days post treatment In
addition, the Agency will maintain the early entry PPE currently on the label, for the reasons stated
                                              52

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above. As a consequence, wheat and barley scouts are probably at little cancer risk with the existing
mitigation measures in place. Diclofop-methyl labels do not need further mitigation for this concern.

       5.      Environmental Risk Mitigation

       For all use sites and application methods of diclofop-methyl, acute and chronic risk quotients
for birds and aquatic animals are generally not of concern.  The Agency, therefore, finds little basis for
risk mitigation.

       In regards to acute risks to both endangered and non-endangered mammals, with the exception
of small herbivorous mammals, the Agency does not have a concern.  Since the Agency's risk
assessment screen indicates that there may be a chronic risk to mammals, risk could further be
evaluated and refined if additional information were provided on an existing study. The Agency is
aware of a study that may show that diclofop-methyl has a foliar half life that is shorter than that
assumed by the Agency. The registrant has agreed to submit this information to the Agency for further
consideration.  If this shorter half life is confirmed, the chronic risk to mammals would be of no concern
to the Agency.

       The use of diclofop-methyl on wheat, barley, and golf course turf is predicted to pose high risk
to non-target terrestrial plants. Threatened and endangered plant species would also be at risk if
exposed to runoff and/or spray drift  Risks generally stem from effects on seedling emergence and
growth from soil exposure.  The Agency is, therefore, concerned with risk to non-target terrestrial
plants.  However,  diclofop-methyl is relatively less toxic than many other commonly used herbicides on
wheat, barley, and golf courses.  Furthermore, the current spray drift language, as set forth by this
document, will reduce the potential exposure to non-target terrestrial plant species.

       The Agency does not have data to adequately assess risk to aquatic plants. In section V of this
document, additional data will be required to allow the Agency to determine risk to aquatic plants.  The
Agency only recently determined that such testing would be required.  Notwithstanding the conclusions
of this RED, the Agency may revisit the need for risk mitigation after reviewing the required data on the
toxicity to aquatic plants.

       F.      Other Labeling Modifications

       Label amendments are necessary such as use and safety information which needs to be placed
on the labeling of all end-use products containing diclofop-methyl.  For the specific labeling statements,
refer to Section V of this document

       Provided the following risk mitigation measures are incorporated in their entirety into labels for
diclofop-methyl-containing products, the Agency finds that all currently registered uses of diclofop-
methyl would be eligible for reregistration.
                                              53

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              1.     Endangered Species Statement

       The Agency has developed the Endangered Species Protection Program to identify pesticides
whose use may cause adverse impacts on endangered and threatened species, and to implement
mitigation measures that will eliminate the adverse impacts.  At present, the program is being
implemented on an interim basis as described in a Federal Register notice (54 FR 27984-28008, July
3,1989), and is providing information to pesticide users to help them protect these species on a
voluntary basis. As currently planned, but subject to change as the final program is developed, the final
program will call for label modifications referring to required limitations on pesticide uses, typically as
depicted in county-specific bulletins or by other site-specific mechanisms as specified by state partners.
A final program, which may be altered from the interim program, will be described in a future Federal
Register notice. The Agency is not imposing label modifications at this time through the RED. Rather,
any requirements for product use modifications will occur in the future under the Endangered Species
Protection Program.

              2.     Spray Drift Management

       The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and
State Lead Agencies for pesticide regulation and other parties to develop the best spray drift
management practices. The Agency is proposing interim mitigation measures for aerial applications that
should be placed on product labels/labeling as specified in section V of Ihis document The Agency has
completed its evaluation of the new data base submitted by the Spray Drift Task Force, a membership
of U.S. pesticide registrants, and is developing a policy on how to appropriately apply the data and the
AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard air-blast and
ground hydraulic methods. After the policy is in place, the Agency may impose further refinements in
spray drift management practices to reduce off-target drift and risks associated with aerial as well as
other application types where appropriate. In the interim, labels should be amended to include the
following spray drift related language.

       For products that are applied outdoors in liquid sprays, regardless of application method, the
following must be added to the labels:

                             "Do not allow this product to drift"

       For outdoor liquid or granular products that are applied aerially, further label language is
necessary for spray drift management Specific label language is outlined in Table 11, "Summary of
Labeling Changes for diclofop-methyr  of this document.
                                             54

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V.     What Registrants Need To Do

       A.     Manufacturing Use Products

              1.     Additional Generic Data Requirements

       The generic data base supporting the reregistration of diclofop-methyl for the above eligible
uses has been reviewed and determined to be substantially complete.  The following data gaps remain:

       •      pH (§ 830.7000) - an aqueous suspension must be tested

              UV/Visible Absorption (§ 830.7050) - product properties

              Dermal Exposure (§ 875.2400)

              Foliar Dislodgeable Residue Dissipation (§ 875.2100)

              Bioaccumulation Study in Fish (§ 850.1730)

              Aquatic Plant Toxicity (§ 850.4400 and 850.5400) - see below

       To fulfill the aquatic/algal plant toxicity guidelines, the following species must be tested at Tier I:
Pseudokirchneria subcapitata and Lemna gibba. Aquatic Tier II studies are required for all low
dose herbicides (those with the maximum use rate of 0.5 Ibs ai/A or less) and any pesticide showing a
negative response equal to or greater than 50% in Tier I tests.  The following species must be tested at
Tier II: Pseudokirchneria subcapitata, Lemna gibba, Skeletonema costatum, Anabaenaflos-
aquae, and a freshwater diatom.

              2.     Labeling for Manufacturing Use Products

       To remain in compliance with FIFRA, manufacturing use product (MUP) labeling must be
revised to comply with all current EPA regulations, PR Notices and applicable policies.

        All registrants must submit applications for amended registration.  This application should
include the following items: completed EPA application form 8570-1, five copies of the draft label with
all required label amendments outlined in Table 11 of this document incorporated, and a description on
the application, such as, "Responding to The Reregistration Eligibility Decision" document. All
amended labels must be submitted within 8 months of signature of this document The Reregistration
Division contact is Veronica Dutch at (703) 308-8585.
                                            55

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       B.
End-Use Products
              1.     Additional Generic Data Requirements

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

              2.     Labeling for End-Use Products

       Labeling changes are necessary to implement measures outlined in Section IV above. Specific
language to implement these changes is specified in the Table 11.  Registrants must submit applications
for amended registratioa This application should include the following items: completed EPA
application form 8570-1, five copies of the draft label with all required label amendments outlined in
Table 11 of this document incorporated, and a description on the application, such as, "Responding to
The Reregistration Eligibility Decision" document  All amended labels must be submitted within 8
months of signature of this document  The Reregistration Division contact is Veronica Dutch at (703)
308-8585.

       C.     Existing Stocks

       Registrants may generally distribute and sell products bearing old labels/labeling for 12 months
from the date of the issuance of this Reregistration Eligibility Decision document. Persons other than the
registrant may generally distribute or sell such products for 24 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 registrant may distribute and sell diclofop-methyl products
bearing old labels/labeling for 12 months from the date of issuance of this RED.  Persons other than the
registrant may distribute or sell such products for 24 months from the date of the issuance of this RED.
Registrants and persons other than the registrant remain obligated to meet pre-existing Agency imposed
label changes and existing stocks requirements applicable to products they sell or distribute.
                                             56

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VI.    Related Documents and How to Access Them

       This Reregistration Eligibility Document is supported by documents that are presently maintained
in the OPP docket. The OPP docket is located in Room 119, Crystal Mall #2,1921 Jefferson Davis
Highway, Arlington, VA. It is open Monday through Friday, excluding legal holidays from 8:30 am to 4
pm.

       All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or
viewed via the Internet at the following site: 'http://www.epa.gov/pesticides/op."
                                            67

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VII.  Appendices
        69

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72

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       Appendix B.  Table Of Generic Data Requirements And Studies Used To Make The
                     Reregistration Eligibility Decision

GUIDE TO APPENDIX B

       Appendix B contains listing of data requirements which support the reregistration for active
ingredients within case #2160 (diclofop-methyl) covered by this RED.  It contains generic data
requirements that apply to diclofop-methyl in all products, including data requirements for which a "typical
formulation" is the test substance.

       The data table is organized in the following formats:

       1 •     Data Requirement (Column 1).  The data requirements are listed in the order in which
              they appear in 40 CFR part 158. the reference numbers accompanying each test refer to
              the test protocols set in the Pesticide Assessment Guidance, which are available from the
              National technical Information Service, 5285 Port Royal Road, Springfield, VA 22161
              (703) 487-4650.

       2.     Use Pattern (Column 2). This column indicates the use patterns for which the data
              requirements apply. The following letter designations are used for the given use patterns.

                     A.     Terrestrial food
                     B.     Terrestrial feed
                     C.     Terrestrial non-food
                     D.     Aquatic food
                     E.     Aquatic non-food outdoor
                     F.     Aquatic non-food industrial
                     G.     Aquatic non-food residential
                     H.     Greenhouse food
                     I.      Greenhouse non-food
                     J.      Forestry
                     K.     Residential
                     L.     Indoor food
                     M.     Indoor non-food
                     N.     Indoor medical
                     O.     Indoor residential
                                             73

-------
3.     Bibliographic Citation (Column 3). If the Agency has acceptable data in its files, this
       column list the identify number of each study. This normally is the Master Record
       Identification (MIRD) number, but may be a "GS" number if no MRID number has been
       assigned. Refer to the Bibliography appendix for a complete citation of the study.
                                      74

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       Appendix C:  Technical Support Documents

       Additional documentation in support of this RED is maintained in the OPP docket, located in
Room 119, Crystal Mall #2,1921 Jefferson Davis Highway, Arlington, VA. It is open Monday through
Friday, excluding legal holidays, from 8:30 am to 4 pm.

       The docket initially contained the risk assessments and related documents as of August 28,2000.
The Agency considered comments on the revised risk assessments and added the formal "Response to
Comments" documents to the docket.

       All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or
viewed via the Internet at the following site:

              www.epa.gov/pesticides/reregistration/diclofop-methyl
                                            81

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82

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       Appendix D.  Citations Considered To Be Part Of The Database Supporting the Interim
                     Reregistration Eligibility Decision (Bibliography)

GUIDE TO APPENDIX D


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

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 Hie
       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
                                             83

-------
       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 (1999), 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.

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.
                                       84

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DICLOFOP METHYL BIBLIOGRAPHY
MRID
CITATION
00003405    Schrader, J.W.; Haskins, W.F. (1974) Experiment: H-183-The Preliminary Evaluation
             of Herbicides for Use in Soybean Production: Project No. 3378. (Unpublished study
             received Oct 8,1976 under 2224-50; prepared by [North Carolina State Univ.],
             Agricultural Experiment Station, Tidewater Research Station, submitted by Mobil
             Chemical Co., Industrial Chemicals, Richmond, Va.; CDL:

00032595    Thackara, J.W.; Rinehart, W.E. (1976) Acute Inhalation Study in Rats: Compound:
             HOE-23408: Project No. 76-1529. (Unpublished study received May 28,1980 under
             8340-12; prepared by Bio/dynamics, Inc., submitted by American Hoechst Corp.,
             SomerviUe,NJ.; CDL:242741-A)

00070615    Hollander, H.; Weigand, W. (1978) Combined Chronic Toxicity and Tumorigenicity
             Study with HOE 23408 O H AT003 in Rats after Dietary Administration for Two Years:
             Report No. 449/78.  (Unpublished study received Aug 17,1978 under 8340-11;
             prepared by Hoechst AG, submitted by American Hoechst Corp., Somerville, N.J.;
             CDL:097282-A; 097281; 097283)

00071522    Mayer, Weigand, (1980) Acute Percutaneous Toxicity Study Conducted with HOE
             23408—Active Ingredient on the Scarified Skin of Male and Female Rats in Compliance
             with EPA-guidelines: Report No. 502/80; A20365. (Translation of doc. no. A20304;
             unpublished study received Dec 19,1980 under 8340-12; prepared by Hoechst AG,
             submitted by American Hoechst Corp., Somerville, N.J.; CDL:244056-A)

00071870    Hollander, H.; Weigand, W. (1978) Toxicity and Tumorigenicity of HOE 23408 O H
             AT003 in Mice during Administration for Two Years: Bericht Nr. 448/78; A14014.
             (Unpublished study received Aug 17,1978 under 8340-11; prepared by Hoechst AG,
             West Germany, submitted by American Hoechst Corp., Somerville, N.J.; CDL:
             097284-A;  097285)

00071904    Gericke, D., Wagner, W.H. (1977)  Test for Mutagenicity in Bacteria Strains in the
             Absence and Presence of a Liver Preparation: A09834. (Unpublished study received
             May 26,1978 under 8340-11; prepared by Hoechst AG, West Germany, submitted by
             American Hoechst Corp., Somerville, N.J.; CDL:097111-B)
                                           85

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DICLOFOP METHYL BIBLIOGRAPHY
MRID
CITATION
00071908    Baeder,Weigand; Kramer, (1975) Test Report on the Embryotoxic Effect of HOE 23
             408 O H on WIstar-rats after Oral Administration: A03604.  (Translation; unpublished
             study received May 26,1978 under 8340-11; prepared by Hoechst AG, West
             Germany, submitted by American Hoechst Corp., Somerville, N.J.; CDL:  097109-A)

00071913    Brunk, Weigand, Kramer, et al. (1977) Report on a Repeated-dose (15 Months) Oral
             Toxicity Study of HOE 23408 O H AT003 in Beagle Dogs: Report No. 809/77;
             A11202.  (Translation; unpublished study received May 26,1978 under 8340-11;
             prepared by Hoechst AG, West Germany, submitted by American Hoechst Corp.,
             Somerville, NJ.; CDL:097109-F)

00076867    LeBlanc, G.A.; Mastone, J.D.; Wilson, B.F. (1981) The Toxicity of Hoelon to Fathead
             Minnow (Pimephales promelas) Embryos and Larvae: Report #BW-81-4-853.
             (Unpublished study received May 21,1981 under 8340-11; prepared by EG & G
             Bionomics, submitted by American Hoechst Corp., Somerville, N.J.; CDL: 245123-G)

00087816    Myhr, B.C.; McKeon, M. (1981) Evaluation of Hoe 23408 O H AS204 in the Primary
             Rat Hepatocyte Unscheduled DNA Synthesis Assay: Genetics Assay No. 5590;
             A21734. Final rept (Unpublished study, including letters dated Jul 14,1980 from H.
             Kelker to Dr. Rochling and Dec 17,1981 from B.I. Doerr to DJ. Lawatsch, received
             Dec 30,1981 under 8340-11; prepared by Litton Bionetics, Inc., submitted by
             American Hoechst Corp., Somerville, N.J.; CDL: 246512-B

00087820    Fumero, S.; Mondino, A.; Peano, S.; et al. (1980) Study of the Mutagenic Activity of the
             Compound Hoe 23408 \vith~Saccharomyces~n~cerevisiae~n: [Submitter] A19671.
             (Translation; unpublished study, including letters  dated Nov 29,1979 from H. Kelker to
             Dr. Rochling and Dec 17,1981 from B.J. Doerr to DJ. Lawatsch, received Dec 30,
             1981 under 8340-11; prepared by Istituto di Ricerche Biomediche, Antoine Marxer,
             S.p.A., Italy, submitted by American Hoechst Corp., Somerville, N.J.; CDL:246512-F)

00098297    Petrocci, A. (1980) Letter sent to D. Greene dated Sep 12,1980: Confirmatory testing
             of customer's products similar to Onyx NP 9.0 prototype: LC 58288.  (Unpublished
             study received Feb 12,1981 under 4170-30; prepared by Onyx Chemical Co.,
             submitted by Betco Corp., Toledo, Ohio; CDL:244740-A)
                                          86

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DICLOFOP METHYL BIBLIOGRAPHY
MRID
CITATION
00123982    Scholz; Weigand (1973) HOE 23408 O H: 2-(4-(2,4-DicWorophenoxy>
             phenoxy)-methyl-propionate: Acute Oral Toxicity Determined with Male SPF Wistar
             Rats: A02158. (Translation; unpublished study received Aug 22,1975 under 6G1664;
             prepared by Hoechst Aktiengesellschaft, W. Ger., submitted by American Hoechst
             Corp., Somerville, NJ; CDL:094678-B)

00123983    Scholz; Weigand (1974) Acute Oral Toxicity of 2-(4-(2.4-Dichloro-
             phenoxy)-phenoxy)-methyl-propionate (HOE 23408 O H) in Female SPF-wistar-rats
             (Carrier Substance: Sesame Oil): A02062. (Translation; unpublished study received Aug
             22,1975 under 6G1664; prepared by Hoechst Aktiengesellschaft, W. Ger., submitted
             by American Hoechst Corp., Somerville, NJ; CDL:094678-C)

00139613    Baeder; Horstmann; Weigand; et al. (1978) Effect of Hoe 23408 O H AT003 on
             Pregnancy of the Rabbit-Strain Hoe:fflMK (SPFWiga)-after Oral Administration:
             Bericht-Nr. 296/78; A17691.  (Translation; unpublished study received Jan 18,1984
             under 8340-11, prepared by Hoechst AG, W. Ger., submitted by American Hoechst
             Corp., Somerville, NJ; CDL:072294-A)

40072901    Hinken, C.; Grimes, I; Jaber, M. (1986) Diclofop-Methyl Technical: (Code: HOE
             023408 OH ZD95 0003): A Dietary LC50 Study with the Bobwhite: Laboratory
             Project ID No. 125-138. Unpublished study prepared by Wildlife International Ltd. in
             cooperation with Analytical Development Corp. 38 p.

40072902    Hinken, C.; Grimes, I; Jaber, M. (1986) Diclofop-Methyl Technical: (Code: HOE
             023408 OH ZD95 0003): A Dietary LC50 Study with the Mallard: Laboratory Project
             ID No. 125-139. Unpublished study prepared by Wildlife International Ltd. in
             cooperation with Analytical Development Corp. 36 p.

40072903    Hinken, C.; Grimes, J.; Jaber, M. (1986) Diclofop-Methyl Technical: (Code: HOE
             023408 OH ZD95 0003): An Acute Oral Toxicity Study with the Bobwhite: Laboratory
             Project ID No. 125-140. Unpublished study prepared by Wildlife International Ltd. 27
             P-
                                           87

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DICLOFOP METHYL BIBLIOGRAPHY
MDRJD
CITATION
40213506     Diehl, K-H.; Last, K-H. (1986) Diclofop-Methyl-OU in Water Emulsion 369
              (g/L)...Testing for Primary Dermal Irritation in Rabbits: Lab Project No.: 86.0404.
              Unpublished study prepared by Hoechst AG.  16 p.

40440901     Beavers, I; Frank, P.; Jaber, M. (1987) Diclofop-Methyl Technical Substance: (Code:
              HOE 023408 OH ZD95 0003): A One-generation Reproduction Study with the
              Bobwhite (CoHnus virginianus): Laboratory Project No.: 125-135. Unpublished study
              prepared by Wildlife International Ltd. 220 p.

40440902     Beavers, J.; Frank, P.; Jaber, M. (1987) Diclofop-Methyl Technical Substance: (Code:
              HOE 023408 OH ZD95 0003): A One-generation Reproduction Study with the
              Bobwhite (Colinus virginianus): Laboratory Project No.: 125-135. Unpublished study
              prepared by Wildlife International Ltd. 220 p.

40520301     Gildermeister, H. (1986) HOE 023408-[Carbon 14] (Diclofop-methyl~[Carbon 14]:
              Leaching Study: Laboratory Project ID CB016/85. Unpublished study prepared
              Hoechst Celanese Corp. Substance: (Code: HOE 023408 OH ZD95 0003): A
              One-generation Re-production Study with the Mallard (Anas plalyrhynchos): Laboratory
              Project No.:  125-136.  Unpublished study prepared by Wild-life International Ltd. 220
              P-

40806302     Koch (1979) Diclofop Free Acid (HOE 21079) - Solubility in Water: Project ID
              A16372. Unpublished study prepared by Hoeschst Ag. 4p.

40806303     Goerlitz, G. (1987) Diclofop-methyl (HOE 023408) - Solubility in Water: Project  ID.
              CP 093/87: Hoechst Report No. A37745. Unpublished study prepared by Hoechst Ag.
              24 p.

40806307     Ellgehausen, H. (1986) Degradation of Diclofop-methyl (HOE 023408) in an Anaerobic
              Aquatic System: Project ID. 056654.  Unpublished study prepared by Research
              Consulting Co. 43 p.
                                           88

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DICLOFOP METHYL BIBLIOGRAPHY
MRID
CITATION
40806308     Goerlitz, G.; Eyrich, U. (1987) Diclofop-methyl (HOE 023408) -Adsorption/Desorption
              in the System Soil/Water: Project ID. A37726. Unpublished study prepared by Hoechst
              AG. 72 p.

41476001     Schollmeister, U.; Leist, K. (1989) Diclofop-methyl, Technical: Lab Project Number:
              A41830/STUDY 89.0664: REPORT 89.1252. Unpublished study prepared by Pharma
              Research Toxicology and Pathology, Hoechst Aktiengesellschaft.  46 p.

41476002     Diehl, K,; Leist, K. (1987) Diclofop-methyl Active Ingredient Technical: Testing for
              Sensitizing Properties in the Pirbright-White Guinea Pig in a Maximization Test: Lab
              Project Number A39087: 87.0763: 88.1229.  Unpublished study prepared by Research
              Toxicology, Hoechst Aktiengesellschaft. 24 p.

41476003     Diehl, K.; Liest, K. (1986) Diclofop-methyl, Active Ingredient Technical: Testing for
              Sensitizing Properties in the Pir bright-White Guinea Pig According to the Technique of
              Buehler: Lab Project Number: A39088: 86. 5034: 88.1228. Unpublished study
              prepared by Pharma Research Toxicology and Pathology, Hoechst Aktiengesellschaft.
              22 p.

41476004     Diehl, K.; Liest, K. (1988) Diclofop-methyl, Active Ingredient Technical: Subacute
              Dermal Toxicity in the Wistar Rat: Lab Project Number: A39230: 86.0539: 88.1262.
              Unpublished study prepared by Pharma Research Toxicology and Pathology, Hoechst
              Aktiengesellschaft.  683 p.

41573302     Franks, T.; Smith, G.; Wilson, R, (1990) Static Acute 96-Hour Toxicity of
              Diclofop-methyl (HOE 023408 00 ZD93 0002) to Rainbow Trout: Lab Project Number:
              A 42731: 89-0162.  Unpublished study prepared by Battelle Columbus Div.  57 p.

41573303     Franks, T.; Smith, G.; Switzer, K.; et al. (1989) Static Acute 48-Hour Toxicity of
              Diclofop-methyl (HOE 023408 00 ZD93 0002) to Daphnia magna: Lab Project
              Number: A/42732: SC890024. Unpublished study prepared by Battelle Columbus Div.
              57 p.
                                           89

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DICLOFOP METHYL BIBLIOGRAPHY
MRTO
CITATION
41573304    Hofman, T.; Jung, R. (1990) Testing for Acute Aerosol Inhalation Toxicily in the Male
             and Female SPF Wistar Rat 4-Hour LC50: Diclofop-methyl Technical (HOE 23408 00
             ZD93 0002) and Addendum to this Report: Lab Project Number: 89/1092: A 42740.
             Unpubblished dy prepared by Hoechst Ag. 32 p.

41573305    Muller, W. (1987) Diclofop-methyl, Substance Technical (Code: HOE 023408 OH
             ZD95 0003): Detection of Gene Mutations in Somatic Cells in Culture HGPRT-Test with
             V79 Cells: Lab Project Number: A 36569. Unpublished study prepared by Hoechst Ag.
             27 p.

41573306    VanDijk, A. (1988) Carbon 14-HOE 023408: Absorption, Distribution, Excretion and
             Metabolism after Single Oral and Repeated Oral Administration to the Rat: Lab Project
             Number: 071910: A 39183. Unpublished study prepared by RCC Umweltchemie Ag.
             183 p.

41573307    Gildemeister, H. (1990) HOE 023408-[carbon 14], Photodegradation in Water: Lab
             Project Number: A 43058: CB89/160. Unpublished study prepared by Hoechst Ag. 61
             P-

41573308    Gildemeister, H. (1990) HOE 023408-[carbon 14]: Photodegradation on Soil: Lab
             Project Number: CB89/161: A 42994. Unpublished study prepared by Hoechst Ag. 49
             p.27. p.

41573309    Gorlitz, G. (1990) HOE 023408, Diclofop-methyul Abiotic Hydrolysis as a Function of
             pH: Lab Project Number: A 42623: CP035/88. Unpublished study prepared by
             Hoechst Ag.  37 p.

41606301    Smith, G.; Schweitzer, M. (1990) Flow-through Acute 96-Hour Toxicity of
             Diclofop-methyl to Bluegill Sunfish: Lab Project Number: SC900064. Unpublished study
             prepared by Battelle, Columbus Div.  61 p.
                                          90

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 DICLOFOP METHYL BIBLIOGRAPHY
 MRID
 CITATION
 41606302
 41606303
41606304
41606305
41606306
41737902
41996902
41996903
 Smith, G.; Schweitzer, M. (1990) Flow-through Acute 96-Hour Toxicity of
 Diclofop-methyl Emulsifiable Concentrate (3 EC Formulation) to Bluegffl Sunfish: Lab
 Project Number: SC900065. Unpublished study prepared by Battelle, Columbus Div
 63 p.

 Smith, G.; Schweitzer, M. (1990) Static Acute 96-Hour Toxicity of Diclofop-methyl
 Emulsifiable Concentrate (3 EC Formulation) to Rainbow Trout: Lab Project Number:
 SC900066. Unpublished study prepared by Battelle, Columbus Div.  61 p.

 Smith, G.; Schweitzer, M. (1990) Static Acute 48-Hour Toxicity of Diclofop-methyl
 Emulsifiable Concentrate (3 EC Formulation) to Daphnia magna: Lab Project Number:
 SC900067. Unpublished study prepared by Battelle, Columbus Div.  67 p.

 Chetram, R. (1990) Tier 2 Vegetative Vigor Nontarget Phytotoxicity Study using
 Technical Diclofop-methyl: Lab Project Number: LR89-42A: 89-0148. Unpublished
 study prepared by Pan-Agricultural Laboratories, Inc. 138 p.

 Chetram, R. (1990) Tier 2 Seed Germination/Seedling Emergence Nontarget
 Phytotoxiciry Study using Technical Diclofop-methyl: Project Number: LR89-42B;
 89-0147. Unpublished study prepared by Pan-Agricultural Laboratories, Inc.  183 p.

 Smith, G. (1990) Static-Renewal Chronic 21-Day Toxicity of Diclofop-methyl to
 Daphnia magna: Lab Project Number: SC900115:  90-0107. Unpublished study
 prepared by Battelle Columbus Div.  8 p.

 Muller, W. (1990) Evaluation of Hoe 023408: Substance Technical in the Unscheduled
 DNA Synthesis Test in Mammalian Cells in Vitro. Unpublished study prepared by
 HoechstAktiengesell-schaft. 21 p.

 Gildemeister, H. (1991) Hoe 023408-Carbon 14: Flow-Through Bioaccumulation and
Metabolism Study with Bluegill Sunfish (Lepomis macrochirus).  Unpublished study
prepared by Hoechst Aktiengese-llschaft. 57 p.
                                           91

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DICLOFOP METHYL BIBLIOGRAPHY
MRID
CITATION
42060501    Osterburg, I. (1991) Diclofop-methyl; Substance Technical: Two Generation Oral
             (Dietary Administration) Reproduction Toxicity Study in the Rat (One Litter per
             Generation): Lab Project No: 927-169-023: A 46373. Unpublished study prepared by
             Hoechst Aktiengesellschaft  1159 p.

42252101    Hey, M.; CzarnecM, J.; and Miller, M (1992) Determination of the Combined Residues
             of Diclofop-methyl and its Metabolite Diclofop (Free Acid) in Soil: Lab Project Number:
             1127:1157. Unpublished study prepared by Colorado Analytical Research and
             Development Corp. and Pan-Agricultural Laboratories, Inc. 557 p.

42347801    Reynolds, J. (1992) Adsorption and Desorption of [carbon 14]-Diclofop-methyl in Four
             Soils: Lab Project Number: XBL 92021: RPT0092. Unpublished study prepared by
             XenoBiotic Laboratories, Inc. 116 p.

42364601    Till, C. (1992) Dermal Absorption in Rat Following Topical Application at Dose Levels  '
             of 0.1,1 and 10 mg Per Animal in Formulation A (Hoelon 3 EW) and Formulation B
             (Hoelon 3 EC): Lab Project Number: M91015: M91026. Unpublished study prepared
             by Hoechst Pharmaceutical Research Laboratories. 343 p.

42428601    Hack, R; Leist, K. (1992) Diclofop-methyl; Substance, Technical: Testing for Primary
             Eye Irritation in the Rabbit:  Lab Project Number: A 47472: 91.0396: 92.0074.
             Unpublished study prepared by Hoechst Aktiengesellschaft.  28 p.

 42461501   Weidenauer, M.; Mollard, L. (1992) Determination of the Dissociation Constant of
             Diclofop (Hoe 021079) According to the OECD Guideline for Testing of Chemicals Nr.
              112, Adopted on 12 May, 1981: Lab Project Number: BE-P-1-92-PK-01-BG.
             Unpublished study prepared by Battelle Europe. 22 p.

42437801     Stammberger, I. (1990) Evaluation of HOE 023408-Substance, Technical: Unscheduled
              DNA Analysis Test in Mamalian Cells in vitro: Lab Project Number: 90. 0527: A 47657.
             Unpublished study prepared by Hoechst Aktiengesellschaft.  8 p.
                                            92

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DICLOFOP METHYL BIBLIOGRAPHY
MRID
CITATION
42543101    Osterburg, I. (1992) Diclofop-methyl: Substance Technical (Code: HOE 023408 OH
             ZD93 0002) Two Generation Oral (Dietary Administration): Reproduction Toxicity
             Study in the Rat: (One Litter Per Generation): Revised Final Report: Lab Project
             Number: A 48800: HLD 169-023. Unpublished study prepared by Hazleton
             Deutschland GmbH. 1193 p.

42573301    Schollmeier, U.; Leist, K. (1992) Subchronic Oral Toxicity (13-week Feeding Study) in
             the Wistar Rat: Diclofop-methyl Technical: Amendment to Report No. 91.1216;
             Doc-No. A 46984:  Lab Project Number: 90.0815: A 47902. Unpublished study
             prepared by Hoechst Aktiengesellschaft 178 p.

42573302    Dulak, L. (1992) Weight of the Evidence Assessment of Diclofop-methyl.  Unpublished
             study prepared by Hoechst-Roussel Agri-Vet Compnay.  32 p.

42796401    Pesselman, R.  (1993) Series 63 Product Chemistry Determinations of Diclofop-methyl
             (Solubility and Stability): Lab Project Number: HWI 6187-135. Unpublished study
             prepared by Hazleton Wisconsin, Inc. 71 p.

43284601    Dionne, E. (1994) Diclofop-methyl: The Chronic Toxicity to the Fathead Minnow
             (Pimephales promelas) During a Full Life-cycle Exposure: Lab Project Number:
            • 1719.0692.6199.122: 94-3-5180. Unpublished study prepared by Springbom Labs,
             Inc.  705 p.

43927302    Ehling, G.; Donaubauer, H. (1996) HOE-023408-Substance Technical (Code: Hoe
             023408 00 ZD95 0004): Combined Chronic Toxicity (12 and 24 Months) and
             Carcinogenicity (24 Months) Study in Rats: Lab Project Number: 92.0475: 95.0691: A
             55998. Unpublished study prepared by Hoechst Aktiengesellschaft. 8320 p.

44158300    AgrEvo USA Co. (1996) Submission of Environmental Fate and Residues Data in
             Support of the  Registration of Diclofop-methyl. Transmittal of 1 Study.
                                           93

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DICLOFOP METHYL BIBLIOGRAPHY
MQRID
CITATION
44532501     Kelly, L; Singer, S.; Johnson, L. et al. (1998) A Small-Scale Prospective Ground-Water
             Monitoring Study for Diclofop-Methyl (Hoelon SEC): Final Report: Lab Project Number:
             BL-94R-01: A59908: 622.02. Unpublished study prepared by Waterborne
             Environmental, Inc., Agvise Labs., Inc. and AgrEvo USA Co.  424 p.

92036013     Leist, K.; Schollmeier, U. (1990) Hoechst Celanese Corporation Phase 3 Summary of
             MRID 00071522. HOE 23408 Technical (Code: HOE 23408 OH AS204) Testing for
             Acute Percutaneous Toxicity on the Abraded Skin of Male and Female Rats in
             Compliance -with EPA Guidelines: Project ID. Nos. A 42814;  80.0502. Prepared by
             HOECHST AKTIENGESELLSCHAFT. 7 p.

92036039     Brunk, R.; Langer, K.; Weigand (1990) Hoechst Celanese Corporation Phase 3
             Reformat of MRID 00071913. Testing of HOE 023408 - Substance Technical (Code:
             HOE 023408 00 ZC98 0002) for Toxicity by Repeated Oral Administration (15 Month
             Feeding Study) to Beagle Dogs: Project ID. No. A 42775; Study Nos. 539, A 34238;
             Report Nos. 809/77, A 34224 and A 36009. Prepared by Hoechst Aktiengesellschaft.
             537 p.

92036042     Albrecht, M.; Baeder, C.; Langer, K.; et al. (1990) Hoechst Celanese Corporation
             Phase 3 Reformat of MRID 00071908. HOE 23408 - Substance Technical (Code:
             HOE 23408 OH AT003) Testing for Embryotoxiciry in the Wistar Rat after Oral
             Administration: AG No. A 42861; Project ID No. G2R0107.  Prepared by Hoechst
             Aktiengesellschaft 376 p.

92036043     Albrecht, M.; Baeder, C.; Langer, K.; et al. (1990) Hoechst Celanese Corporation
             Phase 3 Reformat of MRID 00139613. HOE 23408 - Substance Technical (Code:
             HOE 23408 OH AT003) Testing for Embryotoxicity in the Himalayan Rabbit  after Oral
             Administration: AG No. A 42859; G2K0207. Prepared by Hoechst Aktiengesellschaft.
             256 p.
                                          94

-------
 DICLOFOP METHYL BIBLIOGRAPHY
 MRID
 CITATION
92036046
92036048
 92036052
92036057
 Diehl, K.; Leist, K. (1990) Hoechst Celanese Corporation Phase 3 Summary of MRID
 41476002. Diclofop-methyl, Substance Technical (Code: HOE 023408 00 ZD93
 0002) Testing for Sensitising Properties in the Pirbright-White Guinea Pig in a
 Maximization Test: Project ID. Nos. A 42848; 90.0297. Prepared by HOECHST
 AKTIENGESELLSCHAFT. lip.

 Leist, K.; Schollmeier, U. (1990) Hoechst Celanese Corporation Phase 3 Summary of
 MRID 41476005. Diclofop-methyl, Substance Technical (Code: HOE 023408 00
 ZD95 0003) Subacute Dermal Toxicity (21 Treatments in 30 Days) in the Wistar Rat
 Prepared by HOECHST AKTIENGESELLSCHAFT. 11 p.

 Leist, K.; Schollmeier, U. (1990) Hoechst Celanese Corporation Phase 3 Summary of
 MRID 41476001. Diclofop-methyl, Substance Technical (Code: HOE 023408 00
 ZD93 0002) Testing for Acute Oral Toxicity in the Male and Female Wistar Rat: Project
 ID. Nos. A 42783; 90.0064.  Prepared by HOECHST AKTIENGESELLSCHAFT. 8
 P-

 Hollander, H. (1990) Hoechst Celanese Corporation Phase 3 Reformat of MRID
 00070615.  Testing of HOE 23408 - Substance Technical (Code: HOE 23408 OH
 AT003) Toxicity and Tumorigenicity Study in Rats during Dietary Administration for 2
 Years Including a 3-month Post Treatment Period: Project ID Nos. 538, A32839,
 449/78, A 35833, A 36011, and A 42176.  Prepared by Hoechst Aktiengesellschaft
 4859 p.
92036058
Hollander, H.; Weigand, W. (1990) Hoechst Celanese Corporation Phase 3 Reformat of
MRID 00071870. Testing of HOE 23408 - Substance Technical (Code: HOE 23408
OH AT003) Toxicity and Tumorigenicity Study in Mice during Dietary Administration for
2 Years with Interim Sacrifice after 88 Weeks:Project ID. Nos. 543, A 22103,448/78,
A 21248, A 19622, A 36010, A 33133, A 33158, A 21016, A17684, A 41080.
Prepared by Hoechst Aktiengesellschaft. 5675 p.
                                         95

-------
96

-------
       Appendix E:   Generic Data Call-In


       See attached table for a list of generic data requirements. Note that a complete Data Call-in
(DCI), with all pertinent instructions, is being sent to registrant under separate cover.
                                             97

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       Appendix F:  Product Specific Data Call-in


       See attached table for a list of product-specific data requirements. Note that a complete Data
Call-in (DCI), with all pertinent instructions, is being sent to registrant under separate cover.
                                            101

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                                  107

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       Appendix H:  List of Available Related Documents and Electronically Available Forms

       Pesticide Registration Forms are available at the following EPA internet site:
              http://www.epa.gov/opprd001/forms/.

Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)

Instructions

       1.      Print out and complete the forms. (Note: Form numbers that are bolded can be filled out
              on your computer then printed.)

       2.      The completed form(s) should be submitted in hardcopy in accord with the existing
              policy.

       3.      Mail the forms, along with any additional documents necessary to comply with EPA
              regulations covering your request, to the address below for the Document Processing
              Desk.

              DO NOT  fax or e-mail any form containing 'Confidential Business Information' or
              'Sensitive Information.'

              If you have any problems accessing these forms, please contact Nicole Williams at (703)
              308-5551 or by e-mail at williams.nicole@epamail.epa.gov.

The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
Application for Pesticide Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution of a
Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
http://www.epa.aov/opprd001/forms/8570-l.Ddf.
http://www.eDa.aov/orjord001/forms/8570-4.Ddf.
httD://www.epa.aov/oDDrd001/forms/8570-5.pdf.

http://www.eoa.aov/ODDrd001/forms/8570-17.Ddf.
httD://www.epa.sov/ODDrdOO] /forms/8570-25, pdf.

httD://www.eDa.aov/opprd001/forms/8570-27.pdf.
                                              109

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8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Certification of Compliance with Data Gap Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an Agreement with
other Registrants for Development of Data
Certification with Respect to Citations of Data (in PR Noti
98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties (in PR Notic
98-1)
Self-Certification Statement for the Physical/Chemical
Properties (in PR Notice 98-1)
http://www.epa.aov/opprd001/forms/8570-28.pdf.

httt>://www.eDa.sov/oonrd001/forms/8570-30.pdf
htto://www.epa.2Ov/opprd001/forms/8570-32.pdf.

:&ttp://www.eDa.eov/oDDDrnsdl/PR Notices/pr98-
pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-
pdf.
5 http://www.epa.gov/opppmsdl/PR Notices/pr98-
pdf.
httrj://www.eDa.20v/ot>t>Dmsdl /PR Notices/pr98-
pdf.
Pesticide Registration Kit

Dear Registrant:
              www.epa.gov/pesticides/registrationkit/.
       For your convenience, we have assembled an online registration kit which contains the following
pertinent forms and information needed to register a pesticide product with the U.S. Environmental
Protection Agency's Office of Pesticide Programs (OPP):

       1.     The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food,
             Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act
             (FQPA)ofl996.

       2.     Pesticide Registration (PR) Notices
              a.
              b.
              c.
              d.

              e.
              f
              g-
              h.
83-3 Label Improvement Program-Storage and Disposal Statements
84-1 Clarification of Label Improvement Program
86-5 Standard Format for Data Submitted under FIFRA
87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems
(Chemigation)
87-6 Inert Ingredients in Pesticide Products Policy Statement
90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
95-2 Notifications, Non-notifications, and Minor Formulation Amendments
98-1 Self Certification of Product Chemistry Data with Attachments  (This
document is in PDF format and requires the Acrobat reader.)
                                            110

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 Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR Notices.
 3.      Pesticide Product Registration Application Forms (These forms are in PDF format and will
        require the Acrobat reader.)
 4.
       a.
       b.
       c.
       d.
       e.
        EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
        EPA Form No. 8570-4, Confidential Statement of Formula
        EPA Form No. 8570-27, Formulator's Exemption Statement
        EPA Form No. 8570-34, Certification with Respect to Citations of Data
        EPA Form No. 8570-35, Data Matrix
 General Pesticide Information (Some of these forms are in PDF format and will require fee
 Acrobat reader.)
       a.
       B.
       C.
       d.

       e.
       f.
       g»
        Registration Division Personnel Contact List
        Biopesticides and Pollution Prevention Division (BPPD) Contacts
        Antimicrobials Division Organizational Structure/Contact List
        53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements
        (PDF format)
        40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
        40 CFR Part 158, Data Requirements for Registration (PDF format)
        50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,1985)
Before submitting your application for registration, you may wish to consult some additional sources
of information.  These include:
1.

2.
The Office of Pesticide Programs' Web Site

The booklet "General Information on Applying for Registration of Pesticides in the United
States," PB92-221811, available through the National Technical Information Service
(NITS) at the following address:

              National Technical Information Service (NTIS)
              5285 Port Royal Road
              Springfield, VA 22161

The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in the
process of updating this booklet to reflect the changes in the registration program resulting
from the passage of the FOJPA and the reorganization of the Office of Pesticide Programs.
We anticipate that this publication will become available during the Fall of 1998.
                                      Ill

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      3.     The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center
             for Environmental and Regulatory Information Systems. This service does charge a fee for
             subscriptions and custom searches. You can contact NPIRS by telephone at (765)
             494-6614 or through their Web site.

      4.     The National Pesticide Telecommunications Network (NPTN) can provide information on
             active ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by
             telephone at (800) 858-7378 or through their Web site: ace.orst.edu/info/nptn.

             The Agency will return a notice of receipt of an application for registration or amended
             registration, experimental use permit, or amendment to a petition if the applicant or petitioner
             encloses with his submission a stamped, self-addressed postcard. The postcard must
             contain the following entries to be completed by OPP:

                           Date of receipt
                           EPA identifying number
                           Product Manager assignment

             Other identifying information may be included by the applicant to link the acknowledgment
             of receipt to the specific application submitted. EPA will stamp the date of receipt and
             provide the EPA identifying File Symbol or petition number for the new submissioa The
             identifying number should be used whenever you contact the Agency concerning an
             application for registration, experimental use permit, or tolerance petition.

             To assist us in ensuring that all data you have submitted for the chemical are properly coded
             and assigned to your company, please include a list of all synonyms, common and trade
             names, company experimental codes, and other names which identify the chemical (including
             "blind" codes used when a sample was submitted for testing by commercial or academic
             facilities). Please provide a CAS number if one has been assigned.


                             Documents Associated with this RED


       The following documents are part of the Administrative Record for this RED document and may
included in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents are not
available electronically, but may be obtained by contacting the person listed on the respective Chemical
Status Sheet

       A.     Health and Environmental Effects Science Chapters.
       B.     Detailed Label Usage Information System (LUIS) Report.
                                              112

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