Docket ID: EPA-HQ-OPP-2010-0424 www.regulations.gov

United States Chemical Safety December 2010

Environmental Protection and Pollution Prevention Agency (7510P)



# Pelargonic Acid, Salts, and Esters

Final Work Plan Registration Review

December 2010Docket ID: EPA-HQ-OPP-2010-0424 www.regulations.gov



### TABLE OF CONTENTS

Pelargonic Acid, Esters, and Sa lts Registration Review Team ................................................. 4

I. INTRODUCTION ................................................................................................................. 5

II. SUMMARY OF COMMENTS RECEIV ED ON PRELIMINARY WORK PLAN .. 5

III. RISK ASSESSMENT AND DATA NEEDS ................................................................... 6

IV. TIMELINE ...................................................................................................................... 10

V. GLOSSARY of TERMS & ABBREVIATIONS ................................................................. 12

3Docket ID: EPA-HQ-OPP-2010-0424 www.regulations.gov

Pelargonic Acid, Esters, and Sa lts Registration Review Team

Human Health Nathan Mottl (AD) Colin Walsh (BPPD)

Environmental Effects Srinivas Gowda (AD) Colin Walsh (BPPD) Russell Jones (BPPD)

Chemistry Srinivas Gowda (AD) Colin Walsh (BPPD) Russell Jones (BPPD)

Risk Management Andrew Bryceland (BPPD) Eliza Blair (AD) Lance Wormell (AD)

Office of General Counsel Philip Ross

4Docket ID: EPA-HQ-OPP-2010-0424 www.regulations.gov

I. INTRODUCTION

This is the Environmental Protection Agency’s (EPA or “the Agency”) Final Work Plan (FWP) for the registration review of Pelargonic Acids, Esters and Salts (Case 6077). The FWP includes the expected registration review time line. The work plan also addresses public comments received concerning the Preliminary Work Plan in the Summary Document that was posted in the Pelargonic Acids, Esters and Sa lts registration review docket, and any other comments concerning the initial docket postings. The Summary Do cument provided information on what EPA knows about the pesticide 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 Registration Review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and R odenticide Act (FIFRA) and will review each registered pesticide every 15 years to determine wh ether it continues to m eet the FIFRA standard for registration. Changes in scie nce, 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 practi ces change, all registered pestic ides continue to meet that statutory standard. The public pha se of registration review begins when the initial docket is opened for each case. Information on this program is provided at: http://www.epa.gov/oppsrr d1/registration_review/

.

The Pelargonic Acids, Esters and Salts case includes three active ingredients: pelargonic acid (PC Code 217500); ammonium nonanoate (PC Code 031802); and nonanoic acid, sulfophenyl ester (NOBS), sodium salt (P C Code 089053). Ammonium nonanoate has only biochemical products registere d, while NOBS has only antimicr obial products registered; pelargonic acid has both biochemical and antim icrobial products regist ered. The Preliminary

Work Plan for this case was entered into the doc ket for this registration review on June 30, 2010. The 60-day comment period ended on August 31, 2010. The Preliminary Work Plan document is

available on www.regulations.gov , docket number EPA-HQ-OPP-2010-0424.

II. SUMMARY OF COMMENTS RECEIV ED ON PRELIMINARY WORK PLAN

The Agency received one comment from the Physicians Committee for Responsible Medicine (PCRM) during the comment period on th e initial docket as de scribed below. In addition, the Agency received comments from th e registrant Procter & Gamble specifically regarding NOBS; their comments requested more information on why some previously submitted studies had been considered unacceptable by the Agency and what could be done to upgrade them to “acceptable.” In the PWP, EPA also solicited comments on three specific topics: environmental justice; water body im pairment; and trade irritants. No comments or information were received during the public comment period concerning those three topics.

At Procter & Gamble’s request, EPA hosted a November 30, 2010 meeting to discuss its submission, identify studies that could be upgrad ed, and describe the st eps required to upgrade those studies. EPA provided this information and Procter & Gamble indicated its preliminary intent to supply the additional information once th e registration review data call-in is issued. A

5Docket ID: EPA-HQ-OPP-2010-0424 www.regulations.gov

full summary of the meeting is available on www.regulations.gov, docket number EPA-HQOPP-2010-0424.

The Physicians Committee for Responsible Me dicine requested that the Agency accept studies previously considered unacceptable wher e possible in order to prevent the “unnecessary” use of more animals in a repeat study. The Ag ency thanks PCRM for its comment and agrees with the goal of only requiring animal studies wh en necessary. The Agency has determined that some studies must be upgraded. Upgrading cert ain of these studies wi ll not require use of

animals.

In the Preliminary Work Plan, the Agency solicited comments on three specific topics: environmental justice, water body impairment, and tr ade irritants. No comments or information were received during the comment period concer ning these issues. This document makes final the work plan for the Pelargonic Acids, Este rs and Salts registra tion review process.

III. RISK ASSESSMENT AND DATA NEEDS

In the Preliminary Work Plan, the Agency stated that it considers the database for pelargonic acid and ammonium nonanoate to be complete, and does not anticipate needing any further data for Registration Revi ew of these two chemicals due to their low toxicity and general low probability of human or environmental expos ure when used according to label directions. Further information can be found in “Pelargonic Acid, Salts and Esters Summary Document”, dated June 21, 2010. The following risk assessment and data needs sectio n deals solely with

NOBS.

Nonanoic acid, sulfophenyl ester, sodium salt (NOBS)

Human Health Risk Assessment St atus and Anticipated Data Needs

The Agency has reviewed the hazard and exposure databases for NOBS and anticipates that additional toxicity and exposur e data will be needed for the re gistration review of this case. The Agency completed an initial review of the supporting toxicity database of NOBS in July 1998 (U.S. EPA 1998), and later received additional toxicity data to supp ort this registration (U.S.EPA 1998 and U.S.EPA 2002). Some studies we re classified as unacceptable and may need to be either replaced or upgraded using additi onal information submitted by registrants. It is possible that upgrading a study may only require the submission of additional information and may not require any further testing on the registrant’s part.

Based on its reviews, the Agency believes risk assessments are needed to ensure that the NOBS registration review case meets the FIFRA and FFDCA standards. The Agency will complete the human health risk assessments presented below.

• Toxicological Endpoint Selection using the data submitted in response to the Agency’s anticipated data call-in for this chemical.

• Residential and Occupational Exposure Risk Assessment via mixing/loading powder (e.g. dry flowable powders) for laundry machines at commercial laundromats, laundry machines and hand-washing of clothes.

6Docket ID: EPA-HQ-OPP-2010-0424 www.regulations.gov

Toxicology

Toxicological data provided to the Agency in the past is at this time insufficient to

characterize NOBS’ effect on ma mmals. The Agency has identified deficiencies in several previously submitted studies that make them inadequate for use in a human health risk assessment. The Agency anticipates requiring the data identified below in order to complete a risk assessment. Some of the listed studies have been previously submitted to the Agency and found to be unacceptable. Some of these are upgradeable with the submission of further

information.

Occupational and Residential Exposure

Dermal and inhalation risk assessments may be needed depending on whether dermal and inhalation toxicological data tr iggers the development of t oxicological endpoints for these particular exposure scenarios. The toxicological da taset is inadequate at this point to select toxicological endpoints. Product use informati on was provided to the Agency in 2001 (MRID 45436203), which will aid the Agency in developing use and usage for occupational and residential handler exposures. The risk assessment will be conducted when appropriate toxicological endpoints are selected by the Agenc y. Based on data anticipated to be required for the registration review, the Agency will assess the product as a dry, flowable powder and will review the submitted product use data to develop exposure assumptions.

The Agency anticipates the need for the following studies to complete risk assessments for the registration review of NOBS a nd to develop toxico logical endpoints:

Toxicology

• (GLN 870.1200) Acute dermal toxicity

• (GLN 870.1300) Acute inhalation toxicity

• (GLN 870.2600) Dermal sensitization

• (GLN 870.3250) 90-day Dermal Toxicity

• (GLN 870.3465) 90-day Inhalation Toxicity

• (GLN 870.5100) Bacterial re verse mutation test

• (GLN 870.5385) Mammalian bone marrow chromosome aberration test

• (GLN 870.2600) Dermal sensitization

Occupational and Residential Exposure

• (GLN 875.1200) Dermal exposure indoor

• (GLN 875.1400) Inhalation exposure indoor

• (GLN 875.1600) Applicator Mo nitoring Data Reporting

Further information and detailed justifications for the studies expected to be needed are available in the Agency memorandum “Summary of Human Health Effects Data for the Nonanoic Acid, sulfophenyl ester, sodium salt Registration Revi ew Decision Document”, dated May 19, 2010.

7Docket ID: EPA-HQ-OPP-2010-0424 www.regulations.gov

Product Chemistry Risk Assessment St atus and Anticipated Data Needs

The data submitted pertaining to the physical and chemical characteristics of the active ingredient NOBS are adequate. All product chem istry data requirements have been fulfilled for the active ingredient NOBS. Therefore, the Agency does not anticipate needing additional product chemistry data for NOBS at this time.

Further information is available in th e Agency memorandum “Product Chemistry, Environmental Fate, and Ecotoxic ity Data for Nonanoic Acid, su lfophenyl ester, sodium salt, dated Registration Review Decisi on Document”, dated April 29, 2010.

Environmental Fate and Ecotox icity Risk Assessment Status and Anticipated Data Needs

NOBS is an antimicrobial registered for us e as a household laundry sanitizer. The Agency has reviewed four environmental fate studies, a hydrolysis study (abiotic) and three biodegrability studies (biotic). The hydrolysis study was classifi ed as supplemental and a new hydrolysis study is needed to address this data area. The three biodegradability studies were found to be acceptable.

Environmental fate and ecologi cal risk assessments have no t been conducted for NOBS. The Agency needs to conduct environmental fate and ecological risk assessments for household laundry sanitizers that potentially pass through wa ste water treatment plants (WWTPs) and may be discharged into terrestrial and aquatic envi ronments. Therefore, the Agency anticipates needing environmental fate and ecotoxicity data for NOBS. The following environmental fate and ecotoxicity data ar e anticipated as being needed to conduct an environmental fate and ecological risk assessment:

• Environmental Fate

o (GLN 835.2120) hydrolysis

o (GLN 835.2240) photodegradation in water

o (GLN 850.6800) modified activated sludge respiration inhibition

o (GLN 835.1110) activated sl udge sorption isotherm

• Ecotoxicity

o (GLN 850.5400) algal toxicity (Tie r II) using freshwater green alga, Selenastrum capricornutum

Further information and detailed justifications for the studies expected to be needed are available in the Agency memorandum “Product Ch emistry, Environmental Fate, and Ecotoxicity Data for Nonanoic Acid, sulfophenyl ester, sodium salt Registration Review Decision Document”, dated April 29, 2010.

8Docket ID: EPA-HQ-OPP-2010-0424 www.regulations.gov

Endocrine Disruptor Screening Program

As required under FFDCA section 408(p), EP A has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether 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 other such endocrine effects as the Administrator may designate.” The EDSP employs a two-tiered ap proach to making the 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 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 a ny adverse endocrine related eff ects caused by the substance, and establish a dose-response rela tionship between the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issu ed test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. This list of chemicals was sele cted based on the potential for human exposure through pathways such as food and water, resi dential activity, and cer tain post-application agricultural scenarios. This li st should not be construed as a list of known or likely endocrine disruptors.

Pelargonic Acid; Ammonium Nonanoate; and Nonanoic acid, sulfophenyl ester, sodium salt are not among the group of 58 pe sticide active ingredie nts on the initial list to be screened under the EDSP. Under FFDCA sec. 408(p) the Agen cy must screen all pesticide chemicals. Accordingly, EPA anticipates issuing future EDSP test orders/data call-ins for all pesticide active ingredients.

For further information on the status of the EDSP, the policies and pr ocedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, plea se visit our website: http://www.epa.gov/endo/

.

Endangered Species

Pelargonic Acid

The Agency has no evidence that any endangered or threatened species will be adversely affected if products containing pe largonic acid as the sole active ingredient are used as labeled. The Agency has made a “no effect” finding for th e use patterns of pelargonic acid. Thus, no labeling is expected to be needed for endangered or threatened speci es at this time for products in which pelargonic acid is th e sole active ingredient.

Based on indoor use patterns for antimicr obial end-use products (as a food-contact surface sanitizer), outdoor use patterns for bi opesticide end-use products (as a burn-down herbicide and fly/tick repellent for cattle/horse s), low exposure levels, the chemical's natural occurrence in the environment and living orga nisms, lack of reported adverse effects

9Docket ID: EPA-HQ-OPP-2010-0424 www.regulations.gov

information, very low/non-toxicity potential of pelargonic acid, and rapi d microbial degradation of the active ingredient, the Agen cy expects that the registered uses of pelargonic acid, where it is the sole active ingredient, will have "no effect" (NE) on endangere d or threatened terrestrial or aquatic species, or their designa ted critical habitats, as listed by the U.S. Fish and Wildlife Service (USFWS) and the National Marine Fisheries Service (NMFS). There are no concerns for non-target insects with regards to outdoor uses of pelargonic acid on cat tle and horses to repel flies, ticks and lice because ecotoxicity test on honeybees, revealed lit tle or no toxicity. However, EPA will review any comments made by the public on this document and will conduct an environmental risk assessment, if new in formation provided during the public comment period warrants such action.

Further information is available in the Agency memorandum “Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the Pelargonic Acid Registration Review Document”, dated April 29, 2010.

Ammonium Nonanoate

The Agency has not conducted a risk asse ssment that supports a complete endangered species determination for ammonium nonanoate. The ecological risk assessment planned during registration review will allow the Agency to determine whether ammonium nonanoate’s use has “no effect or “may affect” federally listed threat ened or endangered species (listed species) or their designed critical habitats. When an a ssessment 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 Mari ne Fisheries Services (the Services), as appropriate.

Further information is available in the Agency memorandum “Preliminary Assessment for the Registration Review of Am monium Nonanoate”, dated May 17, 2010.

NOBS

The Agency has not conducted a risk asse ssment that supports a complete endangered species determination for NOBS. The ecological risk assessment plan ned during registration review will allow the Agency to determine wh ether NOBS use has “no effect or “may affect” federally listed threatened or endangered spec ies (listed species) or their designed critical habitats. When an assessment concludes that a pe sticide’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 Fi sheries Services (the Services), as appropriate.

Further information is available in th e Agency memorandum “Summary of Product Chemistry, Environmental Fate, an d Ecotoxicity Data for the N onanoic acid, sulfophenyl ester, sodium salt Registration Review Deci sion Document”, dated April 29, 2010.

10Docket ID: EPA-HQ-OPP-2010-0424 www.regulations.gov

IV. TIMELINE

The projected timeline for the Pelargonic acid, Salts and Esters registration review appears in the table below.

Activities Estimated Month/Year

Phase 1: Opening the docket
Open Public Comment Period for Pelargonic Acid, Salts & Esters

Docket Completed June 2010

Close Public Comment Period Completed August 2010
Phase 2: Case Development

Develop Final Work Plan (FWP) Completed December 2010

Issue DCI December 2011

Data Submission December 2013
Open Public Comment Period for Preliminary Risk Assessments June 2015

Close Public Comment Period September 2015

Phase 3: Registration Review Decision
Open Public Comment Period for Propos ed Reg. Review Decision December 2015

Close Public Comment Period March 2016 Final Decision and Begin Post-Decision Follow-up 2016 Total (years) 6

Next Steps

A Data Call-In (DCI) will be developed re garding the data gaps listed under the “Risk Assessment and Data Needs” section. Also, hum an health and ecological risk assessments will

be conducted for the uses indicated in this document.

11Docket ID: EPA-HQ-OPP-2010-0424 www.regulations.gov

V. GLOSSARY of TERMS & ABBREVIATIONS

ai Active Ingredient AR Anticipated Residue ASTM American Society for Testing and Materials

AWPA American Wood Preserver’s Association

CFR Code of Federal Regulations cPAD Chronic Population Adjusted Dose

CSF Confidential Statement of Formula CSFII USDA Continuing Surveys for Food Intake by Individuals

DCI Data Call-In DEEM Dietary Exposure Evaluation Model DFR Dislodgeable Foliar Residue DNT Developmental Neurotoxicity DWLOC Drinking Water Level of Comparison

EC Emulsifiable Concentrate Formulation EDWC Estimated Drinking Water Concentration

EEC Estimated Environmental Concentration EPA Environmental Protection Agency

EUP End-Use Product FDA Food and Drug Administration FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FFDCA Federal Food, Drug, and Cosmetic Act FQPA Food Quality Protection Act FOB Functional Observation Battery GENEEC Tier I Surface Water Computer Model

IR Index Reservoir

LC 50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or volume of water, air or feed, e.g., mg/l, mg/kg or ppm.

LD 50 Median Lethal Dose. A statistically derive d single dose that can be expected to cause

death in 50% of the test animals when admini stered by the route i ndicated (oral, dermal, inhalation). It is expressed as a weight of substance per unit weight of animal, e.g., mg/kg.

LOC Level of Concern

LOAEL Lowest Observed Adverse Effect Level μg/g Micrograms Per Gram μg/L Micrograms Per Liter mg/kg/day Milligram Per Kilogram Per Day mg/L Milligrams Per Liter MOE Margin of Exposure

MRID Master Record Identifi cation (number). EPA's system of recording and tracking

submitted studies. MUP Manufacturing-Use Product

NA Not Applicable NAWQA USGS National Ambient Water Quality Assessment NPDES National Pollutant Discharge Elimination System

NR Not Required

NOAEL No Observed Adverse Effect Level

OPP EPA Office of Pesticide Programs OCSPP EPA Office of Chemical Safety and Pollution Prevention PAD Population Adjusted Dose PAIRA Pure Active Ingredient Radiolabelled PCA Percent Crop Area

12Docket ID: EPA-HQ-OPP-2010-0424 www.regulations.gov

13 PDP USDA Pesticide Data Program PHED Pesticide Handler's Exposure Data

PHI Preharvest Interval ppb Parts Per Billion

PPE Personal Protective Equipment

ppm Parts Per Million PRZM/EXAMS Tier II Surface Water Computer Model Q 1 * The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model RAC Raw Agriculture Commodity RED Reregistration Eligibility Decision

REI Restricted Entry Interval

RfD Reference Dose RQ Risk Quotient SCI-GROW Tier I Ground Water Computer Model

SAP Science Advisory Panel SF Safety Factor

SLN Special Local Need (Registrations Under Section 24(c)) of FIFRA) TGAI Technical Grade Active Ingredient

TEP Typical End-Use Product USDA United States Department of Agriculture UF Uncertainty Factor

WPS Worker Protection Standard