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 2010 

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

TABLE OF CONTENTS

Pelargonic Acid, Esters, and Salts Registration Review Team................................................. 4 

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

II. SUMMARY OF COMMENTS RECEIVED ON PRELIMINARY WORK PLAN .. 5 

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

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

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

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

Pelargonic Acid, Esters, and Salts 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 

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Docket 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 timeline. 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 Salts registration review docket, and any other 

comments concerning the initial docket postings. The Summary Document 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 Rodenticide Act (FIFRA) and will review 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 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, all registered pesticides continue to meet that 

statutory standard. The public phase of registration review begins when the initial docket is 

opened for each case. Information on this program is provided at: 

http://www.epa.gov/oppsrrd1/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 (PC Code 089053). Ammonium nonanoate has only 

biochemical products registered, while NOBS has only antimicrobial products registered; 

pelargonic acid has both biochemical and antimicrobial products registered. The Preliminary 

Work Plan for this case was entered into the docket 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 RECEIVED ON PRELIMINARY WORK PLAN

 The Agency received one comment from the Physicians Committee for Responsible 

Medicine (PCRM) during the comment period on the initial docket as described below. In 

addition, the Agency received comments from the 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 impairment; 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 upgraded, and describe the steps required to upgrade 

those studies. EPA provided this information and Procter & Gamble indicated its preliminary 

intent to supply the additional information once the registration review data call-in is issued. A 

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Docket 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 Medicine requested that the Agency accept 

studies previously considered unacceptable where possible in order to prevent the “unnecessary” 

use of more animals in a repeat study. The Agency thanks PCRM for its comment and agrees 

with the goal of only requiring animal studies when necessary. The Agency has determined that 

some studies must be upgraded. Upgrading certain of these studies will not require use of 

animals.

In the Preliminary Work Plan, the Agency solicited comments on three specific topics: 

environmental justice, water body impairment, and trade irritants. No comments or information 

were received during the comment period concerning these issues. This document makes final 

the work plan for the Pelargonic Acids, Esters and Salts registration 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 Review of these two chemicals due to their low toxicity and general 

low probability of human or environmental exposure 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 section deals solely with 

NOBS. 

Nonanoic acid, sulfophenyl ester, sodium salt (NOBS)

Human Health Risk Assessment Status and Anticipated Data Needs 

 The Agency has reviewed the hazard and exposure databases for NOBS and anticipates 

that additional toxicity and exposure data will be needed for the registration 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 support this registration 

(U.S.EPA 1998 and U.S.EPA 2002). Some studies were classified as unacceptable and may need 

to be either replaced or upgraded using additional 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. 

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Toxicology

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

characterize NOBS’ effect on mammals. 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 triggers the development of toxicological endpoints for these 

particular exposure scenarios. The toxicological dataset is inadequate at this point to select 

toxicological endpoints. Product use information 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 Agency. 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 and to develop toxicological 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 reverse 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 Monitoring 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 Review Decision Document”, dated 

May 19, 2010. 

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

Product Chemistry Risk Assessment Status and Anticipated Data Needs 

The data submitted pertaining to the physical and chemical characteristics of the active 

ingredient NOBS are adequate. All product chemistry 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 the Agency memorandum “Product Chemistry, 

Environmental Fate, and Ecotoxicity Data for Nonanoic Acid, sulfophenyl ester, sodium salt, 

dated Registration Review Decision Document”, dated April 29, 2010. 

Environmental Fate and Ecotoxicity Risk Assessment Status and Anticipated Data Needs 

NOBS is an antimicrobial registered for use 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 classified 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 ecological risk assessments have not been conducted for NOBS. 

The Agency needs to conduct environmental fate and ecological risk assessments for household 

laundry sanitizers that potentially pass through waste water treatment plants (WWTPs) and may 

be discharged into terrestrial and aquatic environments. Therefore, the Agency anticipates 

needing environmental fate and ecotoxicity data for NOBS. The following environmental fate 

and ecotoxicity data are 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 sludge sorption isotherm 

• Ecotoxicity

o (GLN 850.5400) algal toxicity (Tier 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 Chemistry, Environmental Fate, and Ecotoxicity 

Data for Nonanoic Acid, sulfophenyl ester, sodium salt Registration Review Decision 

Document”, dated April 29, 2010. 

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

Endocrine Disruptor Screening Program 

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 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 approach 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 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 related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 

Between October 2009 and February 2010, EPA issued 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 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. 

Pelargonic Acid; Ammonium Nonanoate; and Nonanoic acid, sulfophenyl ester, sodium 

salt are not among the group of 58 pesticide active ingredients on the initial list to be screened 

under the EDSP. Under FFDCA sec. 408(p) the Agency 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 procedures, the list of 

67 chemicals, the test guidelines and the Tier 1 screening battery, please 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 pelargonic acid as the sole active ingredient are used as labeled. 

The Agency has made a “no effect” finding for the use patterns of pelargonic acid. Thus, no 

labeling is expected to be needed for endangered or threatened species at this time for products in 

which pelargonic acid is the sole active ingredient. 

Based on indoor use patterns for antimicrobial end-use products (as a food-contact 

surface sanitizer), outdoor use patterns for biopesticide end-use products (as a burn-down 

herbicide and fly/tick repellent for cattle/horses), low exposure levels, the chemical's natural 

occurrence in the environment and living organisms, lack of reported adverse effects 

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

information, very low/non-toxicity potential of pelargonic acid, and rapid microbial degradation 

of the active ingredient, the Agency expects that the registered uses of pelargonic acid, where it 

is the sole active ingredient, will have "no effect" (NE) on endangered or threatened terrestrial or 

aquatic species, or their designated 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 cattle and horses to repel 

flies, ticks and lice because ecotoxicity test on honeybees, revealed little 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 information 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 assessment 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 threatened or endangered species (listed species) or 

their designed 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 Services (the Services), as 

appropriate. 

 Further information is available in the Agency memorandum “Preliminary Assessment 

for the Registration Review of Ammonium Nonanoate”, dated May 17, 2010. 

NOBS 

The Agency has not conducted a risk assessment that supports a complete endangered 

species determination for NOBS. The ecological risk assessment planned during registration 

review will allow the Agency to determine whether NOBS use has “no effect or “may affect” 

federally listed threatened or endangered species (listed species) or their designed 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 Services (the Services), as appropriate. 

Further information is available in the Agency memorandum “Summary of Product 

Chemistry, Environmental Fate, and Ecotoxicity Data for the Nonanoic acid, sulfophenyl ester, 

sodium salt Registration Review Decision Document”, dated April 29, 2010. 

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Docket 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 Proposed 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 regarding the data gaps listed under the “Risk 

Assessment and Data Needs” section. Also, human health and ecological risk assessments will 

be conducted for the uses indicated in this document. 

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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 

LC50 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. 

LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause 

death in 50% of the test animals when administered by the route indicated (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 Identification (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 

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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 

Q1* 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