Docket Number EPA

- HQ

- OPP

- 2011

- 091 0 www.regulations.gov



## Undecylenic Acid Summary Document Registration Review: Initial Docket

Dec ember 20113 TABLE OF CONTENTS

Page #

I. Preliminary Wo rk Plan (PWP) 4

II. Fact Sheet 9

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency’s current position based on the following documents:

1. Registration Review

– Preliminary Problem Formulation for the Ecolo gical Risk and Drinking Water Exposure Assessments for Undecylenic Acid

. August 9, 2011.

2. Undecylenic a cid

. Human Health Assessment Scoping Document in Support of Registration Review

. December 14, 2011.

3. BEAD Chemical Profile for Registration Review: U ndecylenic acid

. July 13, 2011.

S upporting documen ts for the registration review of undecylenic acid are located in docket EPA

HQ

- OPP

- 2011

- 0910 at www.regulations.gov.4 I. PRELIMINARY WORK PLAN

Introduction

The Food Quality Protection Act (FQPA) of 1 996 mandated a registration review program. All pesticides distributed or sold in the United States (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Agency), based on scientific data showing that they

will not cause u nreasonable risks to human health or the environment when used as directed on product labeling. 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 pesti cides continue to meet the statutory standard of no unreasonable 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 program, the Agency periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely. Information on this program is provided at: http://www.epa.gov/oppsrrd1/r egistration_review/

.

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 FIFRA standard for registration. 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 docket d uring this initial comment period, the Agency will develop and commit to a final work plan and schedule for the registration

review of undecylenic acid

.

Undecylenic acid is an insecticide and miticide registered for use to kill fleas and mites on pets. I t is

an active ingredient in pet shampoos and pet spray products , which are registered in c ombination

with dioctyl sodium sulfosuccinate (DSS)

. As a pesticidal active ingredient, 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 unrelated 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 ingredient, and is classified as “ Generally Recognized as Safe” (GRAS). Undecylenic acid is an organic unsaturated fatty acid that has structural similaritie s to fatty acids

found in the diet.

Pesticide products containing u ndecylenic acid as an active ingredient were first registered in 19 86

. Therefore, it was not subject to the reregistration requirements of FIFRA and a Reregistration Eligibility Decision (RED) document was not completed for undecylenic acid . For registration

review

, only the use of undecylenic acid as a pesticide active ingredient (in pet shampoos and pet

sprays ) will be considered.5 Anticipated Risk Assessment and Data Needs

The Agenc y does not intend to require additional data on undecylenic acid

. The Agency plans to

conduct a comprehensive ecological risk assessment

, including an end angered species risk

assessment

, for the pesticidal uses of undecylenic acid

. Below is a summary of the issues relevant to the registration review of undecylenic acid

.

Ecological Risk:

**•** No ecological risk assessment has been c omplet ed for undecylenic acid as a pesticidal active ingredient

.

**•** The Agency has not conducted an ecological risk assessment th at supports a complete endangered species determination for undecylenic acid

. The ecological risk assessment planned during registration review will allow the Agency to determine whether undecylenic

acid ’s use has “no effect” or “may affect” federally lis ted 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, th e Agency will

consult with the U.S. Fish a nd Wildlife Service ( FWS ) and/or National Marine Fisheries

Service (NMFS) (the Services), as appropriate.

**•** D ue to the nature of undecylenic acid as a shampoo use on pets (mammals and reptiles )

, no additional data on terrestrial animals (birds, reptiles, an d terrestrial

- phase amphibians) are anticipated as being needed for this registration review

. In addition, because undecylenic

acid is registered for indoor uses, it is anticipated 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 Exposure Assessments for Undecylenic Acid

, dated August 9, 2011 , located in docket EPA

- HQ

- OPP

- 2011

- 0910 at www.regulations.gov

, fo r a more detailed discussion of the anticip ated ecological risk assessment

.

Human Health Risk:

**•** No human health risk assessment has been completed for undecylenic acid as a pest icidal active ingredient.

**•** Because of the extensi ve literature data available on undecylenic acid , its low toxicity, FDA’s approval of the chemical as a drug for use at much higher doses than would be experienced as a result of pesticide

- related uses, and the chemical’s classification by FDA as Generally Recognized as Safe (GRAS) (2 1 CFR 178.3400), the Agency concludes that additional toxicity data will not be needed for this registration review

.6 **•** 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 residential exposure assessment or aggregate risk assessment is required.

**•** There are no tolerance s 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

- OPP

2011

- 0910 at www.regulations.gov

, for a detailed discussion of the human health risk

assessment status.

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neuroto xicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual mat uration, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and 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 assessment 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 Disruptor Screening Program (EDSP). Endocrine Disruptor Screening Prog ram

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect i n humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required determinations. Tier 1

c onsists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) 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 determine 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

- re lated effects 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 may screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued t est orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients

. Undecylenic acid is not among the group of 58 pesticide active ingredients on the initial list to be screened under the E DSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data call

- ins,7 requiring the submission of EDSP screening assays for undecylenic acid

. For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, f uture lists, the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/

.

Timeline

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

Table 1.

Table 1. Projected Undecylenic Acid Registration Review Timeline Activity Estimated Date Opening the D ocket Open Docket and Open Public Comment Period 2011

– December

Close Public Comment Period 201 2

– February Case Development Develop Final Work Plan (FWP) 2012

– May Open Public Comment Period for Draft Risk Assessments 201 2

– July

– Sept.

Close Public Comment Period 201 2

– Oct.

– Dec. Registration Review Decision Develop Proposed Registrat ion Review D ecision and Open Public

Comment Period 201 3

– Jan.

– March

Close Public C omment P eriod 201 3

– April

– June

Issue Registration Review D ecision and Begin P ost

- D ecision F ollow

- up 201 3 Total ( years ) 3

Guidance for Commenters

The public i s invited to comment on EPA’s preliminary w ork plan and rationale s . The Agency will carefully consider all comments, as well as any additional information or data provided in a timely manner, prior to issuing a final work plan for the undecylenic acid cas e.

Trade Irritants :

Through the registration review process, the Agency intends to solicit information on trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution. Growers and other

stakeholders are asked to commen t on any trade irritant issues resulting from lack of Maximum Residue Limits (MRLs) or disparities between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the nature of the concern.

Environmental Justice :

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation,8 and enforcement of environmental laws, regulations, and p olicies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical, unusually high exposure to undecylenic acid c ompared 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.

Water Quality :

Undecylenic acid is not identified as a ca use of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act 1

. In addition, n o Total Maximum Daily Load s (TMDLs) have been developed for undecylenic acid 2 . More information on impaired water bodies

and TMDLs can b e found at the Agency’s website 3

. The Agency invites submission of water quality

data for th is pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired Wa ter Body and

Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management

Process 4 in order to ensure they can be used quantitatively or qualitatively in pesticide risk

assessments.

Next Steps

After the 6 0

- day comment period close s, the Agency will consider and respond to any comments

re ceive d in a timely manner. The Agency expects to issue a Final Work Plan for undecylenic acid in May 2012

.

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

2 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_group_name=PEST ICIDES

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

4 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm9 II. FACT SHEET

Background Information

**•** Registration R eview Case N umber: 4095

**•** P esticide C hemical (PC) Code : 085501

**•** Chemical Abs tracts Service (CAS) Number: 112

- 38

- 9

**•** Undecylenic acid was first registered in the U.S. in 19 8 6

.

**•** Since pesticide products containing undecylenic acid w ere first registered after 198 4

, undecylenic acid was not subject to the reregistration requirements of FIFRA; therefore,

there is no Reregistration Eli gibility Decision (RED ) document for undecylenic acid

.

**•** T echnical registrant : Natural Chemistry, Inc.

**•** Currently , t here are two only two products containing un decylenic acid as an active ingredient for conven tional pes ticide uses.

**•** EPA Registration N umbers : 45729

- 2 and 45729

- 4

**•** Pesticide Re

- evaluation Division (PRD) Contact : Tom Myers ( myers.tom @epa.gov)

**•** Registration Division (RD) C ontact: Richard Gebken ( ge bken.r ichard @epa.gov).

Use and Usage Information

**•** No usage information is available.

Pending Actions

**•** There are no recent or pending action s for undecylenic acid

.

Ecological Risk Assessment Status

The following are key findings

, from both open litera ture and from studies submitted by the technical registrant, regarding the environmental fate

, ecological effects and risks of undecylenic

acid

. Please refer to the Registration Review

– Preliminary Problem Formulation for the Ecological

Risk and Drinkin g Water Exposure Assessments for Undecylenic Aci d

, dated August 9, 2011

, located

in docket EPA

- HQ

- OPP

- 2011

- 0910 at www.regulations.gov , for a d etailed discussion of the ecological risk assessment

.10 Ecological Risks :

**•** No ecological risk assessment has been co mpleted for undecylenic acid as a pesticidal active ingredient.

Human Health Risk Assessment Status

The following are key findings

, from both open literature and from studies submitted by the technical registrant, regarding the human health effects and r isks of undecylenic acid . Please refer to

the Undecylenic acid. Human Health Assessment Scoping Document in Support of Registration

Review

, dated December 14 , 2011, located in dock et EPA

- HQ

- OPP

- 2011

- 0910 at

www. regulations.gov

, for a detailed discussion o f the human health risk assessment status.

Hazard Characterization :

**•** Undecylenic acid has low acute oral, dermal and inhalation toxicity. It is neither a skin sensitizer nor a skin or eye irritant. Results of long

- term toxicity and reproduction studies in the literature did not demonstrate any significant toxicity of undecylenic acid.

Di etary E xposure :

**•** As an active ingredient, there are no food uses for undecylenic acid and there are no

tolerance s established for undecylenic acid

.

**•** B ased on the low t oxicity of undecylenic acid , a quantitative dietary risk assessment is not required. The Agency believe s that there are no dietary risks of concern associated with the

established uses of undecylenic acid

.

Residential E xposure :

**•** There are residential us es for the active ingredient undecylenic acid in shamp oo and spray pet products

. D ue on the low toxicity of undecylenic acid

, the Agency believes that there are no residential risk of concern.

A ggregate Risk :

**•** Since quantitative dietary and residential exposure assessments are not required for undecylenic acid , a quantitative aggregate assessment is not required either. Based on the

low hazard associated with undecylenic acid , the Agency believes that aggregate risks are not

of concern.11 Occupational Risk :

**•** Due to the low toxicity of undecylenic acid , t he Agency believe s there are no occupational

risks of concern.

Cumulative A ssessment :

**•** The Agency has not determined that undecylenic acid shares a common mechanism of toxicity with other chemical su bstances ; therefore, at this time, a cumulative risk assessment to support registration review is not required.

Incident s

Ecologica l Incidents :

**•** Based on the use of undecylenic acid as a pet shampoo and low toxicity , no ecological incidents are expected. The Agency will search the incident database before the issuance of the final work plan.

Human Health Incidents :

**•** Both the OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and H ealth (CDC/NIOSH) Sentinel Event Notification System for Occupational Risk

- Pesticides (SENSOR) database s were consulted.

**•** No incident involving undecylenic acid w as reported between 1998

– 2007, the period

covered in incident database for undecylenic acid

.

Tolerances and International Harmonization

**•** There are no tolerance s established for undecylenic acid

.

Data Call

- In Status

**•** There have been no data call

- ins associated with undecylenic acid

.

L abels

**•** Active Section 3 labels for undecylenic acid can b e obtained from the Pesticide Product Label System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home

.