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### Mecoprop-p (MCPP-p) Preliminary Wo rk Plan – Table of Contents

OVERVIEW ...................................................................................................................... ............. 4

ANTICIPATED DATA NEEDS .................................................................................................... 5

STATUTORY AND REGULATORY AUTHORITY ................................................................... 5

CHEMICAL FACTS ................................................................................................................ ...... 6

USE AND USAGE INFORMATION ............................................................................................ 6

RECENT ACTIONS ................................................................................................................ ....... 8

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW ................................ 8

TIMELINE ...................................................................................................................... .............. 10

NEXT STEPS .................................................................................................................... ........... 10

Appendix – Additional Areas Considered in the MCPP-p Registration Review ..................... 11

References:

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

1. Problem Formulation for th e Environmental Fate and Ecological Risk, Endangered Species, and Drinking Water Assessments in Support of the Regi stration Review of Mecoprop-p (MCPP-p)

. Carey, Steve and Adbel-Saheb, Ibrahim. June 2, 2014.

2. MCPP, MCPP-p (Acid), MCPP-p DMAS, and MCPP-p potassium salt Human Health Assessment Scoping Document in Support of Registration Review. Tadayon, Seyed, Taylor, Linda, and Savoia, Peter. February 28, 2014.

3. MCPP (Mecoprop): Tier I Review of Human Incidents. Recore, Shanna, and Evans, Elizabeth. February 4, 2014.

4. BEAD Chemical Profile (BCP) for Registration Re view of Mecoprop Chemical Case [Includes Mecoprop (03150 1 ); Mecoprop-potassium ( 031503 ); Mecoprop dimethylamine salt (031519);

MCPP-P

, DMA salt (031520); Mecoprop-P potas s i um (1 19046 ); and MCPP-p (1290 46)]

. Hill, Elizabeth, Prieto, Rafael, and Yourman, Leonard. May 23, 2014.3 5. Mecoprop (MCPP) Screening Level Usage Analysis . May 8, 2013

6. Environmental Fate and Effects Divi sion Spreadsheet: PC Codes: 031402, 031403, 031416, 031464, and 031465 . May 5, 2014.

7. Health Effects Division Master Labe l Spreadsheet: PC Codes: 031402, 031403, 031416, 031464, and 031465. May 5, 2014.

These and other supporting documents for the MC PP-p registration review case may be found in the docket EPA-HQ-OPP- EPA-HQ-OPP-2014-0361 at http://www.regulations.gov

.4 OVERVIEW

The docket for the MCPP-p case is now open, initia ting the first public comment period for this registration review (docket num ber EPA-HQ-OPP-2014-0361). This case includes the following active ingredients: mecoprop-p acid (MCPP-p) , MCPP-p dimethylamine salt (MCPP-p DMAS), and MCPP-p potassium salt. The PC codes included in this case are: 129046, 031520, and 119046. These compounds are collectively referred to as MCPP-p. Products containing racemic mecoprop (MCPP) and its salts have been reform ulated to the enriched isomer formulation MCPP-p. Therefore, registration review will focu s solely on MCPP-p and its salts. MCPP-p is a

non-selective herbicide in the chlorophenoxy class of herbicides that is registered for nonagricultural use to control a variety of weeds on co mmercial and residential lawns; turfgrass; golf courses; sod farms; and outdoor residential areas. It is registered for noxious weed and brush control use on uncultivated, non-agricultural areas such as rights -of-way, roadsides, and airports. There are no registered food or feed uses, and MC PP-p products are used primarily in residential, commercial, institutional, and industrial areas. This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticid e Programs knows about MCPP-p, highlighting anticipated data and assessment needs, identify ing the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing the registration review for MCPP-p.

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 MCPP-p and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on MCPPp. The Agency encourages all interested stakeh olders to review the PWP and Appendix and to provide comments and additional information that will help the Agency’s decision-making process for this chemical. In addition to gene ral areas on which persons may wish to comment,

there are some areas identified in the PWP a nd Appendix about which the Agency specifically

seeks comments and information. Interested st akeholders could include : environmental nonprofit or interest groups; pesticide manufacturer s; agricultural labor or commodity groups; commercial, institutional, reside ntial, and other users of pestic ides; or the public at large.

The Preliminary Work Plan begins by listing th e anticipated data need s for MCPP-p. Next, it discusses the statutory and regul atory authority for Registration Review. Then the document provides chemical facts, use and usage info rmation, recent actions, the anticipated risk assessments, and a projected registration review timeline for MCPP-p. Finally, the Appendix to

this document includes identification and discussion of some areas that ar e considered generally in Registration Review along with some a dditional chemical case-specific information.5 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data need s for MCPP-p. For additional discussion of the anticipated data needs, see the Problem Formulation for the Envi ronmental Fate and Ecological Risk, Endangered Species, and Drinking Water Assessments in Support of the Registration Review of Mecoprop-p (MCPP-p) and MCPP, MCPP-p (Acid), MCPP-p DMAS, and MCPP-p potassium salt Human Health Assessment Scopi ng Document in Support of Registration Review.

Table 1: Anticipated Data Needs for the MCPP-p Registration Review

Guideline

Number 1 Study Title 1 Test Material 2 Estimated

Timeframe

(Months from receipt of DCI)

850.2100 Avian oral toxicity (passerine species) TGAI 12
850.2300 Avian reproduction (waterfowl species) TGAI 24

870.3465 3 90-day inhalation toxicity TGAI 12

NONGDLN Pollinator Acute Oral Toxicity (honeybee larvae) TGAI 12

NONGDLN Pollinator Acute Oral Toxicity (honeybee adult) TGAI 12

NONGDLN Pollinator Chronic Oral Toxicity (honeybee adult) TGAI 12

TGAI = technical grade active ingredient;

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. 4

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-2009-0154-0028

2 Data are anticipated to be required on either the acid or DMAS formulation.

3 For the inhalation toxicity study, an acceptable test of 28 days duration woul d be expected to be sufficient to satisfy this anticipated data requirement.

4 http://www.epa.gov/oppsrrd1/registration_review/6 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 MCPP-p.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for MCPP-p.

Table 2: Chemical Facts for MCPP-p

PC code 031520, 119046, and 129046

Case Number 0377 CAS Number 66423-09-4, 16484-77-8, 66423-05-0 Year first registered MCPP:1968; MCPP-p:1996 Pesticide Type Chlo rophenoxy herbicide Chemical class Not applicable. Reregistration Eligibility Decision (RED) 2007

Tolerance Reassessment Eligibility Decision (TRED) Not applicable. There are no food or feed uses of MCPP-p.

Cumulative group Not applicable. MCPP-p has not been identified as a member of a cumulative group that shares a common mechanism of toxicity. 40 CFR Citation There are no established tolerances for MCPP-p. Dual-use MCPP-p is registered for c onventional pesticidal uses only and has no registered antimicrobial or biopesticidal uses. Non-pesticidal uses There are no identi fied non-pesticidal uses of MCPP-p.

Pesticide Re-evaluation Division, Chemical Review Manager Kaitlin Keller, keller.kaitlin@epa.gov , (703) 308-8172

Registration Division, Product Manager Kathryn Montague, montague.kathryn@epa.gov , (703) 305-1243

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage in formation for MCPP-p. Please see the BEAD Chemical Profile (BCP) for Registration Re view of Mecoprop Chemical Case in the registration review

docket for more details.7 Table 3: MCPP-p Use and Usage Information

Summary of Use MCPP-p is a non-selective chlorophenoxy herbicide registered for post-emergent use to control broadleaf and noxious weeds and brush in non-agricultural resident ial, commercial, and industrial areas such as rights-of-way, road sides, golf courses, sod farms,

and residential and commercial lawns. MCPP-p products are commonly co-formulated with othe r herbicides as ready-to-use turfgrass products. MCPP-p is not currently registered for food or agricultural uses. Use Sites Non-agricultural use sites include commercial/industrial areas, turfgrass (commercial/industrial, residential, recreational, golf course, sod farms), uncultivated areas, fencerows/hedgerows, rights-of-way, paths/patios, r ecreational areas, airport landing fields, and grasses grown for seed. Summary of Usage EPA has very limited usage data for MCPP-p due to its nonagricultural and diffuse types of us e patterns. The vast majority of MCPP-p use is primarily for residential lawns, with smaller uses for commercial turf, such as for golf courses. From 2004- 20012, a relatively small amount of MCPP-p was reported on pasture/rangelands; however, it ha s not been reported since 2007. In 2012, approximately 800,000 pounds of MCPP-p formulations

were used on turf and ornamentals. Formulation Type(s) Granules, pressurized liquids, ready-to-use liquids, soluble liquids, wettable powders, pr essurized liquids, flowable concentrates, emulsifiable c oncentrates, and liquid soluble

concentrates. Application Method(s) Products can be applied by granul ar spreaders, handheld/backpack sprayers, gr ound sprayers, trigger spray bottles, mechanical sprays, and aerosol cans. Technical Registrant(s) Nufarm Am ericas, Inc. and PBI/Gordon Corp. No. of Registrations 278 Section 3 products 5

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.

 Certain MCPP-p labels are unclear with respect to application parameters such as the size of the treated area, the extent of a treated “spot,” retreat ment intervals, or maximum annual application rates. Without further in formation, EPA expects to use conservative assumptions to approximate these parameters in order to conduc t a quantitative risk assessment. However, the Agency will work with registrants to clarify information on MCPP-p product labels, especially the ma ximum annual application rates for nonagricultural uses including golf courses, turf , ornamentals, and residential lawns.

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

(http://oaspub.epa.gov/pestlabl/ppls.home).8  Confirmation of the following label information: sites of application; formulations; application methods and equipment; maxi mum application rates; frequency of 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.

 Typical application timing (date of first applic ation and application in tervals) – national, state, and county.

 Usage/use information for non-agricultural us es (total pounds active ingredient applied annually on residential, ornamental, tu rf, rights-of-way, and pastureland).

 Percent crop/site treated.

 Application rates: typical and maximum.

 Frequency of application.

 Typical application interval (days).

 Methods of application.

 Target or niche pests.

 Efficacy information/product performance.

 State or local use restrictions.

 Foreign technical registrants not listed above who supply te chnical MCPP-p to the US

market.

RECENT ACTIONS

There are no recent actions for MCPP-p.

ANTICIPATED RISK ASSESSMENT S FOR REGISTRATION REVIEW

The most recent comprehensive human health risk assessment for MCPP-p was completed on July 26, 2007 in preparation for the 2007 Reregist ration Eligibility Decision. The most recent ecological and environmental fate risk asse ssment was completed August 28, 2007 for the same purpose. Findings and conclusions from thes e risk assessments are summarized in the Problem Formulation for the Environmental Fate and Ecological Risk, Endangered Species, and Drinking Water Assessments in Support of the Registration Review of Mecoprop-p (MCPP-p)

and MCPP, MCPP-p (Acid), MCPP-p DMAS, and MCPP-p potassium salt 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 endangere d species assessment, for all uses of MCPP-p. For human health, EPA anticipates the need to conduct revised dietar y (drinking water only), residential, and occupational risk assessments during registration review . If toxicological endpoints or points of departure ar e revised based on the data that are anticipated to be required for registration review, they will be considered in the new assessments, as well as any changes to the standard operating procedures 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.9 Table 4: Anticipated Risk Assessments for the MCPP-p 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

Incidents Will check for updates For a discussion of reporte d ecological incidents for MCPP-p, see page 16 and Appendix B of the Problem

Formulation.

Human Health Dietary Food N MCPP-p is not currently registered for use on food or

feed. Drinking water Y Updated dietar y (drinking water only) risk assessments may be needed during registration review to consider newly esti mated drinking water

concentrations and/or cha nges in the toxicological endpoints. Occupational Handlers (mixers, loaders, applicators) Y Updated occupational expos ure assessments may be needed during registration review to consider new exposure estimates based on current science policies or if there are changes in the toxicological endpoints. Post-application N There is no evidence of systemic toxicity from dermal exposure. Appropriate re-e ntry intervals (REIs) are currently on product labels, thus significant dermal exposure from recently treated areas is not anticipated.

Residential Handlers Y Updated residential exposure assessments may be needed during registration review to consider new exposure estimates based on current science policies or if there are changes in the toxicological endpoints. Post-application Y

Other Aggregate Y Evaluates the combin ed risk from dietary (drinking water only) and residential exposures. Cumulative N MCPP-p has not been identified as a member of a cumulative group that shares a common mechanism of toxicity.

Tolerances N Tolerances are not established for MCPP-p since it is not registered for use on food or feed at this time.10 Incidents Will check for updates For a discussion of reported human incidents for MCPP-p, see page 9 of the Scoping Document and

the MCPP (Mecoprop): Tier 1 Review of Human

Incidents

.

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 timeline for the completion of the MCPP-p registration

review in Table 5 below.

Table 5: Projected MCPP-p Re gistration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period 2014 – June Close Public Comment 2014 – August Case Development

Final Work Plan 2014 – November

Issue DCI 2015 – Jan.- March

Data Submission 2017 – Jan.- March 60-day Public Comment Period for Draft Risk

Assessments 6 2018 – July - Sept.

Registration Review Decision 60-day Public Comment Period for Proposed Registration Review Decision 2019 – April - June

Registration Review Decisi on and Begin Post-Decision Follow-up 2020

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 MCPP-p.

6 The regulations governing Registration Review generally require the Agency to provide a public comment period

of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pesticides, the Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments.11 

### Appendix – Additional Areas Considered in the MCPP-p 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. Because MCPP-p is not registered for food/feed uses in the U.S., it has no U.S. tolerances; therefore, the Agency does not anticipate any trade irritant issues for it.

Water Quality:

MCPP-p is not identified as a cause of impairment for any water bod ies listed as impaired under section 303(d) of the Clean Water Act. 7 In addition, no Total Maximum Daily Loads (TMDL) have been developed for MCPP-p. 8 More information on impaired water bodies and TMDLs can be found at the Agency’s website. 9 The Agency invites submission of water quality data for this pesticide. To the extent possible, submissions shoul d include the key data elements noted in

the OPP Guidance for Submission of State and Tribal Water Quality Monitoring Data 10 in order to ensure they can be used 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 MCPP- p 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.

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

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

group_name=PESTICIDES

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

10 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm12 ENDANGERED SPECIES:

A risk assessment that supports a complete endangered species determination has not been conducted for MCPP-p. The ecological risk asse ssment planned during registration review will allow the Agency to determine whether use of MCPP-p has “no effect” or “may affect” federally listed threatened or endangered species (listed sp ecies) or their designate d critical habitats. When an assessment concludes that a pesticid e’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.

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 reregistrati on decision for MCPP-p, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), MCPP-p is subject to the endocrine screening part of the Endocrine Disruptor Screenin g 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. Between 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 ingredient s and 9 inert ingredients. A second list

of chemicals identified for EDSP sc reening was published on June 14, 2013 11 and includes some pesticides scheduled for registration review and chemicals found in water

. Neither of these lists

should be construed as a list of know n or likely endocri ne disruptors.

11 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of

chemicals.13 For further information on the status of the ED SP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening ba ttery, please visit our

website. 12

HUMAN STUDIES:

Occupational and Residential

Past MCPP-p risk assessments rely in part on da ta from studies in which adult human subjects were intentionally exposed to a pesticide to de termine their dermal and inhalation exposure. Many such studies, involving exposur e to many different pesticides, comprise generic pesticide exposure databases such as the Pesticide Handl ers Exposure Database (PHED), the Agricultural Reentry Task Force (ARTF) Database, and th e Outdoor Residential Exposure Task Force (ORETF) Database. EPA has reviewed all the studies supporting these multi-pesticide generic exposure databases, and has found no clear and c onvincing evidence that the conduct of any of them was either fundamentally unethical or si gnificantly deficient relative to the ethical standards prevailing at the time the research wa s conducted. All applicab le requirements of EPA’s Rule for the Protection of Human Subject s of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barri er to continued reliance on these studies.

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