2 Introduction:

This is the Environmental Protection Agency’s (EPA or the Agency) Final Work Plan (FWP) for the registration review of flumiclo rac-pentyl. The FWP includes the expected registration review time line. The FWP also addresses public comments received concerning initial docke t postings, including the Preliminary Work Plan (PWP) in the Summary Document . The comments are posted in th e flumiclorac-pentyl registration review docket (EPA-HQ-OPP-2009-0084). The Summary Document provides information on what EPA knows about the pest icide and what additional risk analyses and data or information the Agency believes are needed to make a registration review

decision.

The Agency is implementing the registra tion review program and will review each registered pesticide every 15 years to determin e whether it continues to meet the Federal Insecticide, Fungicide, and Rode nticide Act (FIFRA) standard for registration. Changes in science, public policy, and pesticide use practices will 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, al l registered pesticides continue to meet that statutory standard. The public phase of registration review begins when the initial docket is opened for each case. Informati on on this program is provided at: http://www.epa.gov/oppsrr d1/registration_review/

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Flumiclorac-pentyl is a post-emergence light -dependent peroxidizing herbicide (LDPH) registered for use on field corn, soybeans, cotton, and a variety of non-cropped areas.

There are no labeled residential homeown er uses, but there is potential for nonoccupational exposure from use on public recreational areas.

Since flumiclorac-pentyl wa s first registered in 1994, it was not subject to a Reregistration Eligibility D ecision, but a tolerance reasse ssment was required under the 1996 Food Quality Protection Act (FQPA). Flum iclorac-pentyl was the subject of an August 2005, “Report of the Food Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision (TRED),” (available at http://www.epa.gov/oppsrrd1/REDs/flumiclorac_tred.pdf ).

Updates Since the Summary Document:

• As required under FFDCA section 408(p) , EPA has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain substances (including pesticide active and other ingredie nts) may have an effect in humans or

wildlife similar to an eff ect produced by a “naturally occurring estrogen, or other

such endocrine effects as the Administ rator may designate.” The EDSP employs a two-tiered approach to making the stat utorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estroge n, androgen, or thyroid (E, A, or T)3 hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will de termine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine relate d effects caused by th e substance, and establish a quantitative relationship betw een the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA is issuing test orders/data call-ins for the first group of 67 chemicals, whic h contains 58 pesticide active ingredients and 9 inert ingredients. This list of chemicals was selected based on the potential for human exposure through pathways such as food and water, residential activity, and certain post-application agricultural scenarios. This list should not be

construed as a list of known or likely endocrine disruptors.

Flumiclorac-pentyl is not among the group of 58 pesticide active ingredients on

the initial list to be screened under th e EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide chemicals. Accordingly, EPA anticipates issuing future EDSP orders/data call-i ns for all registration review cases, including those for which EPA has alrea dy opened a registra tion review docket for a pesticide active ingredient.

For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, please

visit our website: http://www.epa.gov/endo /

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• In January 2006, a data call-in (DCI) wa s issued to a group of registrants who hold technical registrations for the LD PHs requiring submission of Guideline number 850.1400, fish early life- stage toxicity test, to measure how different wavelengths of light affect the toxicity of the LDPHs on aquatic organisms. Valent USA, the technical registrant fo r flumiclorac-pentyl, has joined a work group which submitted a modified protocol for Guideline 850.1400, as required by EPA, to detect phototoxicity in fish in the presence of the LDPHs. The protocol has been reviewed and approve d by EPA, and pilot testing for the study

was initiated in November 2009 with subm ission of the data expected in late

2010.

Comments Received on the Preliminary Work Plan:

The Agency received one comment during the 60-day public comment period on the initial flumiclorac-pentyl docket, which opened on September 23, 2009, and closed on November 23, 2009. A description of the comm ent and EPA’s response is provided in the “Summary of Comments and Agency Re sponse” section of this document. The comment did not change the data and risk asse ssment needs or the timeline detailed in the PWP. Therefore, this document finalizes the work plan for the flumiclorac-pentyl registration review process.4 Additionally in the PWP, EPA solicited comments on the specific topics of environmental justice, water body impairment, a nd trade irritants, in addition to questions specific to flumiclorac-pentyl concerning use, usage, benefits, and available alternatives.

No comments or information were receive d during the comment period concerning these

issues.

Risk Assessment and Data Needs:

The Agency will conduct a comprehensive ecol ogical risk assessment for flumicloracpentyl, including an endangere d species assessment, using da ta generated from the newly required studies. A revised human health ri sk assessment will be required if indicated by the newly required studies. Below is a summary of the issues relevant to the registration review of flumiclorac-pentyl.

Ecological Risk:

• The most recent ecological risk assessment was completed in October 2005 to support the proposed (and subsequently regi stered) use of flumiclorac-pentyl on

cotton.

• The Agency has not conducted a risk assessment that supports a complete endangered species determination. The eco logical risk assessment planned during registration review will allow the Agen cy to determine whether flumicloracpentyl’s use has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critical habitats. When an

assessment concludes that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.

• The Agency will conduct a new drinking water assessment during registration review pending the receipt and review of new data.

• Gaps exist in the environmental fate and environmental toxicity databases for flumiclorac-pentyl and its primary degr adate of toxicological concern, IMCA. EPA will require the following guideline st udies in order to conduct a complete ecological risk assessment for the regist ration review of flumiclorac-pentyl. Some of the studies are requi red for the parent flumiclor ac-pentyl while others are required for IMCA.

835.4300 – Aerobic aquatic metabolism (parent) 835.6100 (7) – Environmental chemistry analytical method in soil (independent laborato ry validation only, parent and IMCA) 835.6200 (7) – Environmental chemistry analytical method in water (parent and IMCA) 850.1300 – Aquatic invertebrate life-cycl e, freshwater (IMCA degradate)5 850.1350 – Aquatic invertebrate life-cycl e, saltwater (IMCA degradate) 850.2100 – Avian acute oral toxicity (passerine species, parent) 850.4225 – Seedling emergence, Tier II (IMCA degradate for 10 species of terrestrial plants) 850.5400 – Acute non-vascular aquatic plant growth, Tier II (IMCA degradate for three species of non-vascular aquatic plants)

• Please refer to the July 10, 2009 document “Registration Review – Preliminary Problem Formulation for the Ecological Risk Assessmen t of Flumiclorac-pentyl” in the registration review docket (EPA-HQ-OPP-2009-0084) for a detailed

discussion of risk assessment needs.

Human Health Risk:

• The most recent human health risk a ssessment was conducted in June 2005 to support the TRED and included assessmen ts for the pending (and subsequently registered) new use on cotton.

• Since the previous assessment, the percen t of cotton gin byproducts assumed to be

in the diets of ruminants has been lo wered from 25% to 5%. A new dietary exposure assessment will be conducted during registration review and would reassess the dietary burden to livestock and incorporate any updates to toxicity endpoints, safety factors, and residue levels.

• There are no currently registered reside ntial uses of flumiclorac-pentyl, but adults and children could potentially be exposed through its use in public recreational areas. A new non-occupati onal exposure assessment will be conducted during registration review to incorporate new data, methods, and modeling parameters. Additionally, curre nt maximum application rates, which are below those previously modeled, would be used.

• A new aggregate assessment, comb ining food, drinking water, and nonoccupational exposures, will be cond ucted during registration review.

• A new occupational handler exposure assessment will be conducted during registration review to in corporate new data, methods, and modeling parameters and would include rights-of-way and low/high pressure handwand equipment

scenarios.

• The tolerance expression in 40 CFR §180.477 will be revised during registration review to ensure that it appropriately addresses the metabolites and degradates of flumiclorac-pentyl. The proposed revisions are to the chemical description rather

than the individual tolerance levels.

• The toxicity database for flumiclorac-pentyl is largely complete except for new studies required under the revised 40 CF R Part 158. EPA will be requiring the6 following guideline studies in order to conduct a complete human health risk assessment for the registration review of flumiclorac-pentyl:

870.6200 – Neurotoxicity battery ( acute and subchronic studies) 870.7800 – Immunotoxicity study

• Please refer to the August 28, 2009 document “Flumiclorac-pentyl. Revised Human Health Assessment Scoping Docume nt in Support of Registration Review” in the registration review docket (EPA-HQ-OPP-2009-0084) for a detailed

discussion of the risk assessment needs.

Timeline:

EPA has created the following estimated timeline for the completion of the flumicloracpentyl registration review.

Registration Review for Flumiclorac-pentyl – Projected Registra tion Review Timeline

Activities Estimated Date Opening the docket Open Docket and Public Comment Period 2009 – Sept.

Close Public Comment 2009 – Nov. Case Development

Final Work Plan 2010 – Jan.

Issue DCI 2010 – Oct. - Dec.

Data Submission 2012 – Oct. - Dec. Open Public Comment Period for Preliminary Risk Assessments 2014 – April – June Close Public Comment Period 2014 – July - Sept. Registration Review Decision Open Public Comment Period for Proposed Registration Review

Decision 2014 – Oct. - Dec.

Close Public Comment Period 2015 – Jan. - March Final Registration Review Deci sion and Begin Post-Decision Follow-up 2015

Total (years) 6

Summary of Comments and Agency Responses:

The Agency received one comment during the 60-day public comment period on the PWP from the FIFRA Endangered Species Ta sk Force (FESTF). The comment and EPA’s response is presented below.

Comment: FESTF stated that its data on endang ered species proximity contained in the FESTF Information Management System (FESTF IMS) and NatureServe data submissions to the Agency (MRIDs 46325901, 46486301, and 47260101) “fulfill the data7 requirements... and provide the best available data necessary for the proximity analysis of flumiclorac-pentyl use and listed species locations.” FESTF stat ed that Valent USA Corporation is a current member of FESTF, and as such, is entitled to the FESTF data on federally-listed threatened and endangered species.

Response: The Agency is aware of the informati on and will consider the information contained in the FESTF IMS, as may be appl icable to flumiclorac-pentyl. However, preliminary reviews of the FESTF IMS indicate that these data do not satisfy all of the outstanding data gaps regarding the envir onmental fate and ecological effects of flumiclorac-pentyl identified in the Summary Document . The Agency will conduct a more thorough review during the development of the risk assessments, which will include addressing the status of the outstanding da ta requirements at that time, and the appropriateness of the submitted data to fulfill these requirements.

Next Steps

• The Agency plans to issue a DCI in la te 2010 requiring the flumiclorac-pentyl studies needed to complete both th e ecological and human health risk

assessments.

• The Agency will conduct an ecological risk assessment, an endangered species assessment, and a human health risk assessment for flumiclorac-pentyl.