United States Chemical Safety May 2011

Environmental Protection and Pollution Prevention

Agency (7510P)

Benzoic Acid

Registration Review:

Final Work Plan

May 2011
Docket Number: EPA-HQ-OPP-2010-0692 

www.regulations.gov 

Benzoic Acid 

Registration Review: 

Final Work Plan 

May 2011 

Case # 5107 

Approved By: 

J an Harrigan-Far ly 

irector, Antimicrobials Division 

Date: 

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Benzoic Acid Registration Review Team

Human Health & Environmental Effects

William Hazel

Srinivas Gowda

Risk Management

Seiichi Murasaki

Lance Wormell

Office of General Counsel

Philip Ross

________________________________________

Supporting documents for the Benzoic Acid Case may be found in the registration review docket

EPA-HQ-OPP-2010-0692 located on the internet at www.regulations.gov.
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Introduction

This is the Final Work Plan (FWP) of the Environmental Protection Agency (EPA or “the 

Agency”) for the registration review of benzoic acid (Case 5107). The work plan includes the

expected registration review timeline. The work plan also addresses public comments received 

concerning the Preliminary Work Plan (PWP) in the Summary Document which was posted in 

the benzoic acid 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 Benzoic Acid Preliminary Work Plan (PWP) (PC Code 009101) was published on

December 22, 2010 and the 60-day comment period ended on February 22, 2011. The 

Preliminary Work Plan document is available on www.regulations.gov docket number EPA-HQOPP-2010-0692.

The first product containing benzoic acid (PC Code 009101) as an active ingredient was 

registered in the United States in 1987. Currently, there is only one product registered with EPA. 

Antimicrobial use of Benzoic Acid is currently registered only as a preservative of food-grade 

lubricating oils in industrial facilities. EPA has granted exemptions from the requirement of a 

tolerance for use of benzoic acid as an inert ingredient (preservative) in pesticide formulations 

(40 CFR 180.910 and 40 CFR 180.930).

Comments Received on the Preliminary Work Plan

The Agency received no comments during the public comment period on the initial docket. In 

the PWP, the Agency solicited comments on specific topics: environmental justice, water body 

impairment, trade irritants, and structure activity relationships. No comments or information 

were received during the public comment period concerning these issues.

Therefore, the data needs, work plan, and timeline described in the PWP remain as they were 

presented initially. Further, this document makes final the work plan for the benzoic acid

registration review process.

Risk Assessments and Data Needs

The Agency will conduct a human health risk assessment. The Agency will require additional 

data to conduct the registration review for benzoic acid.
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Ecological Risk Assessment Status and Data Needs

No ecological risk assessment has been performed for benzoic acid. Based on available 

environmental fate and ecotoxicity data for benzoic acid, EPA believes that the currently 

registered use pattern of benzoic acid as a material preservative in the mineral oil component 

of lubricants will not cause unreasonable adverse effects on the environment, and is not 

anticipated to cause adverse effects on fish, invertebrates, plants or other wildlife.

The Agency does not anticipate the need to require additional ecological data for the 

registration review at this time.

The Agency does not anticipate the need to require additional environmental fate data for the 

registration review at this time.

For more information, please refer to Summary of Product Chemistry, Environmental Fate, 

and Ecotoxicity Data for the Benzoic acid Registration Review Decision Document, located 

in the docket.

Human Health Risk Assessment Status and Data Needs

The most recent human health risk assessments for benzoic acid were completed in 1993, for 

EPA’s Integrated Risk Information System (IRIS) report. Risk assessments were not 

conducted to support the 2007 RED because there were no registrations at the time the RED 

risk assessments were completed.

Dietary Assessment

A quantitative assessment of dietary (food) risk has not been deemed necessary as part of this 

Registration Review because human dietary exposure to residues of Benzoic acid from 

pesticidal sources will be minimal compared to direct food-additive uses, pharmaceutical use, 

cosmetic uses, and naturally-occurring residues (especially in fruits). 

A dietary (drinking water) risk assessment is not required because human dietary exposure to 

residues of Benzoic acid in drinking water is not expected. Benzoic acid is used to preserve 

food-grade lubricants for equipment in commercial food-handling establishments (an indoor 

use) and discharges or disposal of treated lubricant into aquatic environments is expected to 

be minimal.

Tolerances and International Harmonization

EPA has granted exemptions from the requirement of a tolerance for use of benzoic acid as 

an inert ingredient (preservative) in pesticide formulations (40 CFR 180.910 and 40 CFR 

180.930).

Occupational and Residential Assessment and Risk

Dermal and inhalation routes of occupational applicator exposure are likely to occur during 

open-pour loading and mixing of the product with food-grade industrial lubricants.
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Occupational dermal risk is not recommended for assessment because of the low dermal 

hazard, the label requirement that gloves be worn, and the rapid rate of excretion.

Quantitative occupational inhalation risk assessments are expected to be needed as Benzoic 

acid is a crystalline solid, is somewhat volatile, and may be loaded via the open-pour method.

A 28-day rat inhalation toxicity study is available that is expected to be considered adequate 

for occupational inhalation risk assessment. The Agency will have this study scientifically 

evaluated for use during the risk assessment stage of the Benzoic acid Registration Review.

Modeling will be used to estimate worker inhalation exposure once the product use and 

human activity studies and particle size distribution have been received.

Label instructions requiring that handlers wear protective eye covering are sufficient to 

protect workers from the eye irritation effects of exposure to Benzoic acid.

The product is for use only in industrial settings; residential exposure is not expected and 

assessment of residential risk is not planned for the Benzoic acid Registration Review at this 

time.

Aggregate and Cumulative Exposure and Risk

In examining aggregate exposure, EPA takes into account the available and reliable 

information concerning exposures to pesticide residues in food and drinking water, as well as 

non-occupational pesticide exposures. An aggregate risk assessment has not been deemed 

necessary for benzoic acid because any non-occupational exposure from pesticidal uses of 

benzoic acid (i.e., dietary food) is expected to be minimal compared to levels of benzoic acid 

that occur naturally in food. Additionally, the FDA has classified benzoic acid (21 CFR 

184.1021) as Generally Recognized as Safe (GRAS) for use as a food additive. Furthermore, 

following dietary exposure, benzoic acid is rapidly metabolized and excreted.

EPA does not have, at this time, available data to determine whether benzoic acid has a 

common mechanism of toxicity with other substances or how to include this pesticide in a 

cumulative risk assessment.

For the purposes of this Registration Review, EPA has assumed that benzoic acid does not 

have a common mechanism of toxicity with other substances when used as an antimicrobial 

as registered. 

Human Health Data Needs

The Agency anticipates the need to require the following additional human health data to 

conduct the registration review of benzoic acid.

875.2700 -- Product use information

875.2800 -- Description of human activity
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For more information, please refer to Benzoic acid. Human Health Effects Scoping 

Document for the Registration Review Decision, located in the docket.

Product Chemistry Data Needs

The Agency anticipates the need to require the following additional product chemistry data to 

conduct the registration review of benzoic acid.

830.7520 -- Particle size, fiber length, and diameter distribution

For more information, please refer to Summary of Product Chemistry, Environmental Fate, 

and Ecotoxicity Data for the Benzoic acid Registration Review Decision Document, located 

in the docket.

Incidents:

Ecological:

No benzoic acid ecological incidents have been reported in the OPP incident database.

Human Health:

No benzoic acid human poisoning incidents have been reported in the OPP incident database.

Endangered Species

Based on the low hazard and exposure, the Agency concludes that the registered uses of benzoic 

acid 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 Oceanic and Atmospheric Administration's (NOAA) National Marine Fisheries Service 

(NMFS). EPA anticipates conducting no further analysis of potential risks to endangered or 

threatened species unless public comment provides data or information that would otherwise 

inform the Agency's determination.

Endocrine Disruptor Screening Program

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, neurotoxicity, 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 maturation, 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, 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), benzoic acid is subject to the 

endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). 
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EPA has developed the 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.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. 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. Benzoic acid is 

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

EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data callins, requiring the submission of EDSP screening assays for benzoic acid. For further information 

on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the 

test guidelines and the Tier 1 screening battery, please visit our website: 

http://www.epa.gov/endo/.

Timeline

EPA has created the following estimated timeline for the completion of the benzoic acid

registration review:

Anticipated Schedule

Activities Estimated Month/Year

Phase 1: Opening the docket

Open Public Comment Period for Docket December 2010 – Complete

Close Public Comment Period for Docket February 2011 – Complete

Phase 2: Case Development

Develop Final Work Plan (FWP) May 2011 – Complete

Issue DCI June 2012

Data Submission June 2013

Open Public Comment Period for Preliminary Risk Assessments December 2014

Close Public Comment Period for Preliminary Risk Assessments March 2015

Phase 3: Registration Review Decision

Open Public Comment Period for Proposed Reg. Review Decision June 2015

Close Public Comment Period for Proposed Reg. Review Decision September 2015

Final Decision and Begin Post-Decision Follow-up December 2015

Total (years) 5
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Next Steps

A DCI will be developed regarding the data needs listed under the “Risk Assessments and Data 

Needs” section of this document. The Agency expects to issue the DCI in June 2012. Following 

submission of required data, a human health risk assessment will be conducted.