2 

### Dimethomorph Preliminary Work Plan – Table of Contents

Overview 3

Anticipated Data Needs 4

Statutory and Regulatory Authority 5

Chemical Facts 5

Use and Usage Information 6

Recent Actions 7

Anticipated Risk Assessments for Registration Review 7

Timeline 9

Next Steps 9

Appendix – Additional Areas Considered in Dimethomorph’s Registration Review 10

References:

This Preliminary Work Plan summarizes the En vironmental Protection Agency's current position based on the following documents:

1. Registration Review: Prelim inary Problem Formulation for Environmental Fate and Ecological Risk, Endangered Species, and Drin king Water Assessments for Dimethomorph

. S. Carey. January, 31, 2013.

2. Dimethomorph: Human Health Assessment Sc oping Document in Support of Registration

Review . S. Piper. January 31, 2013.

3. BEAD Chemical Profile for Registration Review: Dimethomorph. C. Chen. July 27, 2012.

4. Dimethomorph: Review of Human Incidents . S. Recore. November 8, 2012.

These and other supporting documents for the dime thomorph registration review case may be found in the docket EPA-HQ-OPP-2013-0045 at http://www.regulations.gov

.3 OVERVIEW

The docket for dimethomorph is now open, initia ting the first public comment period for this registration review (docket number EPA-HQ- OPP-2013-0045). Dimethomorph is a systemic morpholine fungicide developed to control downy mildews, late bli ghts, and crown and root rots on grapes, potatoes, tomatoes, and other vegetables . Dimethomorph is also registered for use on various non-agricultural sites, such as forest trees and orna mental plants, but there are no registered residential uses. This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about di methomorph, highlighting anticipated data and assessment needs, identifying the types of inform ation that would be especially useful to the Agency in conducting the review, and providi ng an anticipated timeline for completing dimethomorph’s review.

The registration review process was designed to include a publi c participation component to solicit input from interested stake holders. The Agency intends, by sharing this information in the docket, to inform the public of what it knows abou t dimethomorph and what types of new data or other information would be helpful for the Agen cy to receive as it moves toward a decision on dimethomorph. The Agency encourages all inte rested stakeholders to review the PWP and Appendix and to provide comments and addition al information that will help the Agency’s decision-making process for this chemical. In addition to general areas on which persons may wish to comment, there are some areas iden tified in the PWP and Appendix about which the Agency specifically seeks comments and informa tion. Interested stakeholders could include: environmental non-profit or interest groups; pe sticide manufacturers; agricultural labor or commodity groups; commercial, institutional, reside ntial, and other users of pesticides; or the public at large.

The Preliminary Work Plan begins by listing the anticipated data needs for dimethomorph. Next, it discusses the statutory and re gulatory authority for Registrati on Review. Then the document provides dimethomorph’s chemical facts, us e and usage information, recent actions, the anticipated risk assessments, and a projected registration review timeline. Finally, the Appendix

to this document includes identification and di scussion of some areas that are considered generally in Registration Review along with some additional chem ical case-specific information.4 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data n eeds for dimethomorph. For additional discussion of the anticipated data needs, see the Registration Review: Prelimi nary Problem Formulation for Environmental Fate and Ecological Risk, Endan gered Species, and Drinki ng Water Assessments for Dimethomorph and Dimethomorph: Human Health Assessment Scoping Document in Support of Registration Review

.

Table 1: Anticipated Data Needs for Dimethomorph’s Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.6100 Terrestrial field dissipation study (full study) TEP 24

850.1400 Fish early-life stage toxicity (freshwater fish, rainbow trout) TGAI 12

850.2100 Avian oral toxicity (passerine species) TGAI 12

850.6100 Environmental chemistry methods and associated independent laboratory validation for water TGAI 12

TGAI = technical grade active ingred ient; TEP = typical end-use product

1 On June 27, 2012, EPA announced certain revisions in harmonized guideline series 850 – Ecological Effects Tests

– including renumbering and other designations or changes for some guideline studies. See “Final Test Guidelines; OCSPP 850 Series; Notice of Av ailability” 77 FR 38282 , June 27, 2012. http://www.regulations.gov/#!documen tDetail;D=EPA-HQ-OPPT-2009-0154-00285 STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All pesticides distributed or sold in the United Stat es (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Ag ency), based on scientific data showing that they will not cause unreasonable ri sks to human health or the environment when used as directed on product labeling. The registration review program is intended to ma ke sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonabl e adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review prog ram, the Agency periodically r eevaluates pesticides to make sure that as change occurs, products in the mark etplace can be used safely. Information on this program is provided on EPA’s website 2

.

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a nd will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. The regulations governing regi stration review begin at 40 CFR 155.40. The Agency will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses

and data or information it believes are needed to make a registration review decision. After reviewing and responding to comments and data received in the docke t during this initial comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for the registration review of dimethomoprh.

CHEMICAL FACTS

Table 2 provides a summary of dimethomorph’s chemical facts.

Table 2: Dimethomorph Chemical Facts

PC code 268800

Case Number 7021

CAS Number 110488-70-5 Year first registered 1998 Pesticide Type Fungicide Chemical class Morpholine Reregistration Eligibility Decision (RED) Because it was registered after November 1984, dimethomorph was not subject to reregistration

Tolerance Reassessment Eligibility Decision (TRED) Not applicable

Cumulative group Dimethomorph is not part of a cumulative group.

2 http://www.epa.gov/oppsrrd1/registration_review/6 Table 2: Dimethomorph Chemical Facts

40 CFR Citation Tolerances for dimethom orph are established in 40 CFR Part

180.493. Dual-use Conventional pe sticidal uses only. Non-pesticidal uses None

Pesticide Re-evaluation Division, Chemical Review Manager Monica Wait, E-mail: Wait.monica@epa.gov, Phone: (703) 347-

8019

Registration Division, Product Manager 20 Driss Benmhend, E-mail: Benmhend.driss@epa.gov, Phone: (703)

308-9525

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage information for dimethomorph. Please see the BEAD Chemical Profile for Regist ration Review: Dimethomorph in the registration review docket for

more details.

Table 3: Dimethomorph Use and Usage Information

Summary of Use Dimethomorph is a systemic morpholine fungicide which is mainly used to control two important crop diseases, downy mildew and late blight Use Sites Agricultural use sites incl ude lettuce, onions, tobacco, potatoes, cucurbits, spinach, cabbage, peppe rs, grapes, and tomatoes. Nonagricultural use sites include fo rest trees, herbaceous plants, ornamentals, woody shrubs and vine s, and ferns. There are no registered residential uses. Summary of Usage Annual agricultural us age is approximately 35,000 pounds of active ingredient (a.i.) with lettuce acc ounting for approximately 60% of usage. In 2006 non-agricultural us age in nurseries was reported to be 9,800 pounds a.i. Formulation Type(s) Dispersibl e granules, wettable powder, a nd emulsifiable and soluble

concentrates. Application Method(s) Products can be a pplied by groundboom, aerially, or chemigation Technical Registrant(s) BASF Corporation No. of Registrations 11 Section 3 products 3

Restricted Use No

Guidance for Commenters: Additional areas of use and usage related information requested for this registration review, and of part icular interest to EPA, are described below.

 Confirmation of the following label information: sites of application; formulations; application methods and equipment; maxi mum application rates; frequency of

3 Section 3 product labels can be obtained from th e Pesticide Product Label System (PPLS) website

(http://oaspub.epa.gov/pestlabl/ppls.home).7 application, application intervals, and maxi mum number of applica tions per season; and geographic limitations on use.

 Use distribution ( e.g. , acreage and geographical distri bution of relevant use sites).

 Median and 90 th percentile reported use rates (lbs a i/A) from usage data – national, state, and county.

 Application timing (date of firs t application and application in tervals) – national, state, and county.

 Usage/use information for non-agricultural uses.

 Typical application interval (days).

 State or local use restrictions.

 Foreign technical registrants not listed above who supply te chnical dimethomorph to the

US market.

RECENT ACTIONS

Dimethomorph risk assessments were complete d in 2011 to support requests for new uses on grapes, brassica subgroups 5A a nd 5B, and green onions. The new uses were gran ted, tolerances were established, and other tolerances were re vised in a May 4, 2012 Federal Register Notice (77 FR 26462).

ANTICIPATED RISK ASSESSMENT S FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for dimethomorph was completed on September 15, 2011 for registration related ne w use requests, as described in “Recent Actions” above. The most recent ecological and environmental fate risk assessment was also completed in 2011 for the same purpose. Findings and conclusions from these risk assessments

are summarized in the Registration Review: Prelimi nary Problem Formulation for Environmental Fate and Ecological Risk, Endan gered Species, and Drinki ng Water Assessments for Dimethomorph and Dimethomorph: Human Health Assessment Scoping Document in Support of Registration Review.

During registration review, the Agency antici pates the need to conduct a comprehensive ecological risk assessment, including an enda ngered species assessment, for all uses of dimethomorph. For human health, EPA anticipat es the need to conduct revised dietary and occupational risk assessments. If toxicological endpoints or points of depa rture are revised based on the data that are anticipated to be required fo r registration review, they will be considered in the new assessments, as well as any changes to the standard operating pr ocedures or default exposure assumptions.

Table 4 below summarizes the anticipated regi stration review risk assessments based on the

EFED Problem Formulation and HED Scoping Document.8 Table 4: Anticipated Risk Assessments for Dimethomorph’s Registration Review

Type of Risk Assessment Conduct? Notes

Ecological and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms), including endangered species Y For terrestrial exposures, risk calculations will be for the parent dimethomorph alone. Due to an unidentified degradate at up to 16% of the applied radioactivity, for aquatic e xposures, risk calculations are anticipated to be base d on two approaches: 1) parent alone and 2) pare nt dimethomorph plus the unidentified degradate, assuming the degradate is stable and as toxic as the parent.

Incidents Will check for updates Currently, there are no repor ted ecological incidents for dimethomorph. For further information, see page

12 of the EFED Problem Formulation.

Human Health Dietary Food Y Only a chronic dietary exposure assessment is anticipated because no acute endpoint has been identified for dimethomorph. Drinking water Y The previous dr inking water assessment used a conservative Tier I approach and was conducted for the parent dimethomorph only. During registration review, the Agency will consider whether an unidentified degradate, r ecovered at up to 16% of applied radioactivity, sh ould be included in the anticipated drinking water assessment. Occupational Handlers (mixers, loaders, applicators) Y The anticipated occupational assessment will be for inhalation exposures only because no dermal endpoint

was identified in available studies. Post-application Y

Residential Handlers N There are no registered residential uses. Post-application N

Other Aggregate N Because there are no residential exposures, an aggregate assessment, which evaluates the combined risk from dietary and residential exposures, is not

needed. Cumulative N Dimethomorph is not part of a cumulative group.

Tolerances Y Current tolerances , established in 40 CFR Part 180.493, will be evaluated during registration review.9 Table 4: Anticipated Risk Assessments for Dimethomorph’s Registration Review

Type of Risk Assessment Conduct? Notes

Incidents Will check for updates At this time, there does no t appear to be a concern

that would warrant furt her investigation of dimethomorph human incidents. For a more detailed discussion, see Dimethomorph: Review of Human

Incidents in the docket or page 6 of the HED Scoping

Document.

Guidance for Commenters: Additional ecological information requested for this registration review, and of particular interest to EPA, is described below.

 Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and mammalian mortalities) not alr eady reported to the Agency.

 Water quality monitoring data (s ee Appendix for further details).

TIMELINE

EPA has created the following estimated ti meline for the completion of dimethomorph’s registration review in Table 5 below.

Table 5: Projected Regi stration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period 2013 – March Close Public Comment 2013 – May Case Development Final Work Plan 2013 – August Issue DCI 2014 – April - June Data Submission 2016 – April - June 60-day Public Comment Period for Draft Risk Assessments 2017 – Oct. - Dec. Registration Review Decision 60-day Public Comment Period fo r Proposed Registration Review

Decision 2018 – April - June

Registration Review Decision and Begin Post-Decision Follow-up 2019 Total (years) 6

NEXT STEPS

After the 60-day public comment period closes , the Agency will review and respond to any comments received in a timely manner and then i ssue a Final Work Plan for the registration review of dimethomorph.10 

### Appendix – Additional Areas Considere d in Dimethomorph’s Registration
Review

PUBLIC COMMENTS AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of special interest to the Agency where your comments, data submi ssions, or reference to sources of additional information could be of particular use.

Trade Irritants:

Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, take steps toward facilitating irritant resolution. The Agency will work to harmonize tolerances and international maximum residue limits (MRLs) and may modify tolerance levels to do so, when possible. Growers and other stakeholders are asked to

comment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. tolerances and MRLs in key export markets, provi ding as much specificity as possible regarding

the nature of the concern.

Water Quality:

Dimethomorph is not identified as a cause of impair ment for any water bodies listed as impaired under section 303(d) of the Clean Water Act 4 . In addition, no Tota l Maximum Daily Loads (TMDL) have been developed for dimethomorph 5 . More information on impaired water bodies and TMDLs can be found at the Agency’s website 6

. The Agency invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedur e: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Regist ration Review Risk Assessment and Management Process 7 in order to ensure they can be us ed quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to dimeth omorph compared to the general population. Please comment if you are aware of any sub-populations that may have atypical, unusually high exposure compared to the general population.

4 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

5 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl _pollutant_detail?p_pollutant_group_id=885&p_pollutant_ group_name=PESTICIDES

6 http://www.epa.gov/owow/tmdl/

7 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm11 ENDANGERED SPECIES:

A risk assessment that supports a complete endangered species determination has not been conducted for dimethomorph. The ecological risk assessment planned during registration review will allow the Agency to determine whether dimethomorph’s use has “no effect” or “may affect” federally listed threatened or endangered specie s (listed species) or their designated critical habitats. When an assessment concludes that a pe sticide’s use “may affect” a listed species or its designated critical habitat, the Agency will c onsult with the U.S. Fish and Wildlife Service

and/or National Marine Fisheries Service (the Se rvices), as appropriate.

On January 19, 2011, the Center for Biological Diversity and the Pesticide Action Network

North America filed a lawsuit in the United States District Court for the Northern District of California, against the Environmental Protecti on Agency (EPA) for allegedly failing to undergo

consultation with the United States Fish and W ildlife Service and the National Marine Fisheries Service regarding the effect s of over 350 pesticides, incl uding dimethomorph, on over 200 endangered and threatened species throughout the United States (C enter for Biological Diversity, et al. v. EPA, et al., No. C 11-00293 (N.D.Cal.)

.

ENDOCRINE DISRUPTOR SCREENING PROGRAM:

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include e ndpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. As part of its most rece nt registration decisi on for dimethomorph, EPA
reviewed these data and select ed the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), dimethomorph is subject to the endocrine screen ing part of the Endocri ne Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whet her certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e statutorily required

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between12 October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pest icide active ingredients and 9 inert ingredients. Dimethomorph is not among the group of 58 pesticide active ingred ients on the initial list to be screened under the EDSP. Accordingly, as part of registrati on review, EPA will issue future EDSP orders/data call-ins, requiring the submissi on of EDSP screening assays for dimethomorph. For further information on the status of the EDSP, the polic ies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website 8

.

HUMAN STUDIES:

Occupational

Past dimethomorph risk assessments rely in pa rt on data from studies in which adult human subjects were intentionally exposed to a pest icide to determine their dermal and inhalation exposure. Many such studies, i nvolving exposure to many different pesticides, comprise generic pesticide exposure databases such as the Pestic ide Handlers Exposure Database (PHED) and the Agricultural Reentry Task Force (ARTF) Databa se. EPA has reviewed all the studies supporting these multi-pesticide generic exposure databa ses, and has found no clear and convincing evidence that the conduct of any of them was either fundamentally unethical or significantly deficient relative to the ethical standards prevai ling at the time the research was conducted. All applicable requirements of EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on

these studies.

8 http://www.epa.gov/endo/