Docket Number EPA-HQ-OPP-2011-0910 www.regulations.gov



## Undecylenic Acid Final Work Plan Registration Review May 20123 Undecylenic Acid Final Work Plan

Introduction

This is the Environmental Protection Agency’s (EPA or the Agency) Final Work Plan (FWP) for the registration review of undecylenic acid. The FWP includes the expected registration review timeline. The FWP also addresses any public comments received on the Preliminary Work Plan (PWP) in the Summary Document, which was posted in the undecyle nic acid registration review docket (EPA-HQ-OPP-2011-0910). The Summary Document, dated December 15, 2011, provided information on what EPA knows about the pesticide a nd what additional risk analyses and data or information the Agency believes are needed to make a registration review decision.

The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rode nticide Act (FIFRA), and will re view each registered pesticide every 15 years to determine whether it continues to meet the FIFRA 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 that statutory standard. The public phase of registration review begins when the initial do cket is opened for each case. Information on this program is provided at http://www.epa.gov/oppsrrd1/registration_review/

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Undecylenic acid is an insecticide and miticide register ed for use to kill fleas and mites on pets. It is an active ingredient in pet shampoos and pet spra y products, which are regi stered in combination with dioctyl sodium sulfosuccinate (DSS). As a pesticidal active ingredie nt, there are no food uses and no tolerances established for undecylenic acid. In addition to its pesticidal uses registered by EPA, undecylenic has other uses in products unre lated to the EPA registered uses on pets. Undecylenic acid has antifungal properties and is approved by the U.S. Food and Drug Administration (FDA) as an over-the-counter drug to treat various skin conditions in humans. It can also be used as a flavoring ingred ient, and is classified as “Gener ally Recognized as Safe” (GRAS). Undecylenic acid is an organic unsaturated fatty acid that has structural similarities to fatty acids

found in the diet.

Pesticide products containing undecylenic acid as an act ive ingredient were first registered in 1986. Therefore, it was not subject to the reregistra tion requirements of FIFR A and a Reregistration Eligibility Decision (RED) document was not co mpleted for undecylenic acid. For registration review, only the use of undecylenic acid as a pest icide active ingredient (in pet shampoos and pet sprays) will be considered.

Comments Received on the Summary Document

No comments were received dur ing the 60-day public comment pe riod on the planned ecological assessment and human health scoping document discussed in the Preliminary Work Plan . In the Preliminary Work Plan , EPA also solicited comments on three specific topics: environmental4 justice, water body impairment, and trade irritants. No comments or information were received during the comment period concer ning these three topics.

Anticipated Risk Assessment and Data Needs

The Agency does not intend to require additional data on undecylenic acid. The Agency plans to conduct a comprehensive ecological risk assessm ent, including an endangered species risk assessment, for the pesticidal uses of undecylenic aci d. Below is a summary of the issues relevant to the registration review of undecylenic acid.

Ecological Risk:

 No ecological risk assessment has been comple ted for undecylenic acid as a pesticidal active ingredient.

 The Agency has not conducted an ecological risk assessment that supports a complete endangered species determination for undecyle nic acid. The ecological risk assessment planned during registration review will allow th e Agency to determine whether undecylenic acid’s use has “no effect” or “may affect” fede rally listed threatened or endangered species (listed species) or their designated critical ha bitats. 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 Se rvice (FWS) and/or National Marine Fisheries Service (NMFS) (the Serv ices), as appropriate.

 Due to the nature of undecylenic acid as a shampoo use on pets (mammals and reptiles), no additional data on terrestrial animals (birds, re ptiles, and terrestrial- phase amphibians) are anticipated as being needed for this regist ration review. In addition, because undecylenic acid is registered for indoor uses, it is anti cipated that no additional ecological data will be required for this registration review.

 Please refer to the Registration Review – Preliminary Problem Formulation for the Ecological Risk and Drinking Water Expos ure Assessments for Undecylenic Acid , dated August 9, 2011, located in docket EPA-HQ-OP P-2011-0910 at www.regulations.gov, for a

more detailed discussion of the an ticipated ecological risk assessment.

Human Health Risk:

 No human health risk assessment has been co mpleted for undecylenic acid as a pesticidal active ingredient.

 Because of the extensive literature data av ailable on undecylenic ac id, its low toxicity, FDA’s approval of the chemical as a drug fo r use at much higher doses than would be experienced as a result of pest icide-related uses, and the chemical’s classification by FDA as5 Generally Recognized as Sa fe (GRAS) (21 CFR 178.3400), th e Agency concludes that additional toxicity data will not be needed for this registration review.

 A quantitative human health risk assessment is not required under registration review for the existing uses of undecylenic acid. There are no risks of concern associated with undecylenic acid. No dietary or residentia l exposure assessment or aggregate risk assessment is required.

 There are no tolerances established for undecylenic acid.

 Please refer to the Undecylenic acid. Human Health Assessment Scoping Document in Support of Registration Review , dated December 14, 2011, located in docket EPA-HQ-OPP2011-0910 at www.regulations.gov, for a detailed discussion of the human health risk

assessment status.

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 endpoints which may be susceptible to endocrine influen ce, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fert ility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessme nts, EPA evaluates acute tests and chronic studies that assess growth, developmental an d reproductive effects in different taxonomic groups. As part of its most recent registration decision for undecylenic acid, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessme nt scenarios from the existing hazard database. However, as required by FFDCA section 408(p), undecylenic acid is subject to the endocrine screening part of the Endocrine Di sruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (inc luding pesticide active and other ingredients) may have an effect in humans or wildlife si milar to an effect produced by a “naturally occurring estrogen, or ot her such endocrine effects as th e Administrator may designate.” The EDSP employs a two-tiered approach to making th e statutorily required de terminations. Tier 1 consists of a battery of 11 scr eening assays to identify the poten tial of a chemical substance to interact with the estrogen, androge n, or thyroid (E, A, or T) horm onal systems. Chemicals that go through Tier 1 screening and are foun d to have the potential to inte ract with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 te sting is designed to identify any

adverse endocrine-related effects caused by the substance, and estab lish a dose-response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency may screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/dat a call-ins for the first group of 67 chemicals,6 which contains 58 pesticide active ingredients and 9 inert ingredients. Undecylenic acid is not among the group of 58 pesticide active ingredients on th e initial list to be scr eened under the EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data call-ins, requiring the submission of EDSP screening assays for undecylenic acid. For further information on the status of the EDSP, the policie s and procedures, the lis t of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/

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Timeline

The projected timeline for the completion of the und ecylenic acid registration review is presented in

Table 1.

Table 1. Projected Undecylenic Ac id Registration Review Timeline Activity Estimated Date Opening the Docket Open Docket and Open Public Comment Period 2011: December Close Public Comment Period 2012: February Case Development Develop Final Work Plan (FWP) 2012: May Open Public Comment Period for Draft Risk Assessment 2012: July – Sept.

Close Public Comment Period 2012: Oct. – Dec. Registration Review Decision Develop Proposed Registration Revi ew Decision and Open Public

Comment Period 2013: Jan.–March

Close Public Comment Period 2013: April –June Issue Registration Review Decision a nd Begin Post-Decision Follow-up 2013 Total (years) 3

Next Steps

The Agency plans to conduct a comprehensive ecol ogical risk assessment, including an endangered species risk assessment, for the pesticide uses of undecylenic acid. The draft of that risk assessment is scheduled to be available for public comment in 2012.