2

I NTRODUCTION

This is the Environm ental Protection Agency’s (EPA or the Agency ) Final Work Plan (FWP) for the registration review of MCPP

- p . This work plan addresses public comments received concerning the Preliminary Work Plan (PWP), which was posted in the MCPP

- p registration review docket (EPA

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- 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 reformulated to the enriched isomer formulation MCPP

- p. Therefore, registration review will focus solely on MCPP

- p and its salts. MCPP

- p is a non

selective herbicide in the chlorophenoxy class of herbicides that is registered for non

- agricultural use to control a variety o f weeds on commercial 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 MCPP

- p products are used primarily in residential, commercial, institutional, and industrial areas.
The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered pesticide every 15 years to determine whether it continues to meet the F IFRA standard for registration. Changes in science, public policy, and pesticide use practices occur over time. The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard. The public phase of registration review begins when the initial docket is opened for each case. Informatio n on this program is provided on the Agency’s website

. 1

The FWP begins with any update s since the PWP was issued. Next is a summary of substantive comments received during the public comment period for the PWP concerning anticipated data needs
, expected risk assessments, or the estimated timeline identified in the PWP
, and a summary of the Agency’s response s to th o se comments

. This section is followed by registration review planned data needs, risk assessments expected to be conducted , and the projected registration review timeline for MCPP

- p

. Lastly , there is a discussion of next ste ps.

UPDATES SINCE THE PWP WAS ISSUED
The honey bee larvae chronic oral toxicity study (non

- guideline) was identified as a data need in the Problem Formulation, but was inadvertently left out of the MCPP

- p PWP. Table 1: Planned Data Needs for the MCPP

- p Registration Review has been updated to include this data need.

SUMMARY OF COMMENTS AND AGENCY RESPONSES
During the 60

- day public comment period on the MCPP

- p Preliminary Work Plan , which opened

on June 25, 2014 and closed on August 25, 2014 , the Agency received 5 sets of public comments. Comments were submitted by the Center for Biological Diversity, the FIFRA

1 http://www.epa.gov/oppsrrd1/registration_review/3

Endangered Species Task Force, t he MCPP

- p Task Force, the San Francisco Bay Regional Water Quality Control Board , and the Central Va lley Regional Water Quality Control Board

. The comments do not address the timeline described in the PWP, but they do address the planned ecological and human health risk assessments and data requirements. In the PWP, EPA also solicited comments on the s pecific topics of environmental justice, water quality concerns , and trade irritants, but no comments or information were received on those issues.
This section does not capture every comment made about the PWP nor all of the Agency’s responses. Summariz ed below are public comments that are of a broader regulatory nature. Comments and Agency responses related to the anticipated ecological risk assessment or data needs are in the EFED R esponse to Public C omments the EFED Problem Formulation for the Enviro nmental Fate and Ecological Risk, Endangered Species, and Drinking Water Assessments (DP Barcode: 416759) in Support of the Registration Review of Mecoprop

- p (MCPP

-

p )

. Public comments and EPA responses in their entirety are located in the docket, EPA

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- 2014

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. Comment submitted by Brett Hartl, Endangered Species Policy Director, Center for Biologic Diversity in EPA

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Comment: The Center for Biological Diversity’s (CBD) comments focus on the EPA’s duty to consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) on the registration review of MCPP

- p in accordance with the Endangered Species Act (ESA). The CBD comments mention various aspects of the risk assessment process, including use of the best available data to develop endangered species risk assessments, and evaluation of effects on endangered and threatened species and their de signated critical habitat. CBD also expresses concern regarding the rigor of the Agency’s preliminary determinations regarding the effects of MCPP

- p on endangered and threatened (listed) species and their designated critical habitat for the MCPP

- p registr ation review.
Response: EPA has reviewed the comments from CBD on the registration review docket opening for MCPP

- p and plans to address many of the concerns raised by CBD as part of the implementation plan for assessing the risks of pesticides to listed species based on the recommendations of the April 2013 National Academy of Sciences (NAS) report. EPA will address concerns specific to MCPP

- p in connection with the development of its final registration review decision for MCPP

- p.
In November 2013, the EPA, along with the Services and the USDA, released a summary of their joint i nterim a pproaches for assessing risks to endangered and threatened (listed) species from pesticides in the white paper Interim Approaches for National

- Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report, dated November 1, 2013 . The Interim Approaches were developed jointly by the agencies in response to the National Academy of Sciences’ (NAS) recommendations and reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific differences between the EPA and the Services. The NAS report outlines recommendations on specific scientific and tech nical issues related to the development of pesticide risk assessments that EPA and the Services must conduct in connection with their obligations under the ESA and FIFRA.4

The joint Interim Approaches were released prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presented the joint Interim Approaches at the December 2013 Pesticide Program Dialogue Committee (PPDC) and State

- FIFRA Issues Research and Evaluation Group (SFIREG) meetings. The agencies also held a stakeholder

wo rkshops in April 2014 and October 2014, allowing additional opportunities for stakeholders to comment on the Interim Approaches . Additional workshops are planned to enhance stakeholder involvement. As part of a phased, iterative process for developing th e Interim Approaches , the agencies will also consider public comments on the Interim Approaches in connection with the development of upcoming Registration Review decisions.
Given that the agencies are continuing to develop and work toward implementatio n of the Interim Approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, the ecological problem formulation supporting this FWP for MCPP

- p does not describe the specific ESA analysis, including effect s determinations for specific listed species or designated critical habitat, to be conducted during registration review. In the ecological problem formulation document for MCPP

- p, EPA described the screening

- level risk assessment to determine the potenti al effects of MCPP

- p on all taxa of

non

- target wildlife and plants, which will assume that listed species and their designated critical habitats may be present in the vicinity of the application of MCPP

- p. This screening

- level assessment will allow EPA to focus its future evaluations on the types of species where the potential for effects exists once the scientific methods being developed by the agencies have been fully vetted. While the agencies continue to develop a common method for ESA analysis, the planned screening

- level risk assessment for the registration review of MCPP

- p will describe the level of ESA analysis completed for this particular registration review case. Once the agencies have fully developed and implemented the scientific methods nece ssary to complete risk assessments for endangered and threatened (listed) species and their designated critical habitats, these methods will be applied to subsequent analyses for MCPP

- p as part of completing this registration review.
Comment submitted by Dan Campbell, chair, Administrative Committees, Syngenta on behalf of FIFRA Endangered Species Task Force (FESTIF) in EPA

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Comment: The technical registrants for MCPP

- p, as identified on the fact sheet included in the PWP, are Nufar

m Americas, Inc

. , and PBI/Gordon Corp., which are FESTF members and are entitled to rely on FESTF data.
Response: EPA will consider this comment during registration review of MCPP

- p

.5

Comments submitted by C.M. Schofield, Chair, Technical Committee, M CPP

- p Task Force in EPA

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- 0 011 :

Comment: The MCPP

-

p Task Force makes several comments clarifying that the technical registrants are only supporting MCPP

- p (PC codes 031520, 119046, and 129046) for Registration Review.
Response: The Agency concurs that this Registration Review case includes only the active ingredients mecoprop

- p acid (MCPP

- p), MCPP

- p dimethylamine salt (MCPP

- p DMAS), and MCPP

- p potassium salt; collectively referred to as MCPP

- p. At the time of the PWP , certain MC PP

- p registrations were coded with incorrect PC codes, but have since been corrected. The PC Codes that are part of the MCPP

- p registration review are 031520, 119046, and 129046

.
Comment: The MCPP

-

p Task Force requests a number of DERs for studies cited w ithin Registration Review documents.
Response: The Agency will provide the available DERs for the requested studies to the MCPP

- p Task Force.

Comment: The MCPP

-

p Task Force comments that the Scoping D ocument and PWP state that there are no food uses or tolerances for MCPP

- p at this time, however Canadian MRLs have been established.
Response: The Agency acknowledges the MCPP

- p Task Force’s comment, and clarifies that there are no registered food or feed uses or established tolerances in the United States

.
Comment: The MCPP

-

p Task F orce provided several comments on the Bead Chemical Profile (BCP) and Screening Level Usage Analysis (SLUA) to clarify pasture application practices

. Response: The Agency acknowledges and thanks the Task Force for this information and will consider it during registration review

.
Comment: The MCPP

-

p T ask F orce comments that BEAD has requested updated usage information and that Task Force member registrants expect to develop updated use and usage information during Regis tration Review, but it is not currently available.
Response: The Agency will consider this information once received.6

PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for MCPP

- p based on 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, MCPP

- p (Acid), MCPP

-

p DMAS
, and MCPP

-

p Potassium Salt Human Health A ssessment Scoping Document in Support of Registrati on Review

. The honey bee larvae chronic oral toxicity study (non

- guideline) was identified as a data need in the Problem Formulation, but was inadvertently left out of the MCPP

- p PWP

. The table below has been updated to include this data need

.

Table 1: Planned D ata Needs for the MCPP

- p Registration Review

Guideline Number 2 Study Title 2 Test Material 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 90

- day inhalation toxicity TGAI 12 NON

GDLN Honey bee adult acute oral toxicity TGAI 12

NON

GDLN Honey bee larvae acute oral toxicity TGAI 12

NON

GDLN Honey bee adult chronic oral toxicity TGAI 12

NON

GDLN Honey bee larvae chronic oral toxicity TGAI 12

TGAI = technical grade active ingredient; TEP = typical end

- use product ;

RISK ASSESSMENTS FOR REGISTRATION REVIEW
During registration review, the Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of MCPP

- p. For human health, EPA anticipates the need to conduct revised dietary (drinking water only), residential, and occupational risk assessments during registration review. If tox icological endpoints or points of departure are 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 ex posure assumptions.

2 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 A vailability” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!documentDetail;D=EPA

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Table 2 below summarizes the planned registration review risk assessments based on the EFED Problem Formulation and HED Scoping Document . T he planned assessments have not changed from what was included in the PWP

.

Table 2: Planned 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 reported 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 dietary (drinking water only) risk assessments may be needed during registration review to consider newly estimated drinking water concentrations and/or changes in the toxicological endpoints. Occupational Handlers (mixers, loaders, applicator s) Y Updated occupational 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 N There is no evidence of systemic toxicity from dermal exposure. Appropriate re

- entry intervals (REIs) are currently on product labels, thus significant dermal exposure from recently treated areas is not anticipated. Residential Handlers Y Updated residential exposure assessme nts 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 combined 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 f

or use on food or feed in the U.S. at this time. 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.8

TIMELINE

EPA has created the following estimated timeline for the completion of the MCPP

- p registration review in Table 3 below

. The projected timeline has not changed since the PWP.

Table 3: Registration Review for MCPP

- p

– Projected Registration Review Timeline Activities Estimated Date Opening the D ocket Open Docket and 60

- day Public Comment Period June 2014

– Completed Close Public Comment June 2014

– Completed Case Development Final Work Plan December 2014

– Completed Issue DCI 2015

– Jan.

- March Data Submission 2017

– Jan.

- March 60

- day Public Comment Period for Draft Risk Assessments 3 2018

– July

- Sept. Registration Review Decision 60

- day Public Comment Period for Proposed Registration Review D ecision 2019

– April

- June
Registration Review D ecision and Begin P ost

- D ecision F ollow

- up 2020 Total ( years ) 6

NEXT STEPS
As noted previously, the Agency plans to require several environmental fate, ecological effects, and human health studies for MCPP

- p through a D ata C all

- I n Notice , expected to be issued in March 2015

.

3 The regulations governing Registration Review gen erally 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.