United States Chemical Safety May 2011 Environmental Protection and Pollution Prevention Agency (7510P)



# Benzoic Acid Registration Review : Final Work Plan May 2011Docket 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 l y

irector, Antimicrobials Division

Date:

20f9Docket Number: EPA

- HQ

- OPP

- 2010

- 0692

www.regulations.gov

3 of 9 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

________________________________________ S upporting 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

.Docket Number: EPA

- HQ

- OPP

- 2010

- 0692

www.regulations.gov

4 of 9 Introduction

This is the Final Work Plan (FWP) of the Environmental Protection Agency (EPA o r “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 rev iew 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 m ake 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. I nformation 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 6 0

- day comment period ended on February 22, 2011 . The Preliminary Work Plan document is available on www.regulations.gov docket number EPA

- HQ

OPP

- 2010

- 0692

. The first product containing benzoic acid (PC Code 009101 ) as an active ingredient was registered in the U nited 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 commen t period on the initial docket. In the PWP, the Agency solicited comments on specifi c 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 need s , 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.

Ris k 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.Docket Number: EPA

- HQ

- OPP

- 2010

- 0692

www.regulations.gov

5 of 9 Ecological Risk Assessment Status and Data Needs

No ecological risk assessme nt 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 lubrican ts 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 regis tration review at this time.

The Agency does not anticipate the need to require additional environmental fate data for the registration review at this time.

F or 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 Integrat ed 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) r isk 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 f

or 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 foo d

- grade industrial lubricants.Docket Number: EPA

- HQ

- OPP

- 2010

- 0692

www.regulations.gov

6 of 9 Occupational dermal risk is not recommended for assessment because of the low dermal hazard, the label requirement that gloves be worn, a nd 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 stud y 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 Ben zoic acid Registration Review.

Modeling will be used to estimate worker inhalation exposure once the product use and human activity studies and particle size di stribution have been received.

Label instructions requiring that handlers wear protective eye covering are sufficient to protect workers fro m 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.

Aggr egate 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. A n 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 th is 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 activityDocket Number: EPA

- HQ

- OPP

- 2010

- 0692

www.regulations.gov

7 of 9 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

F or 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 re ported 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) Nati onal 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.

Endocri ne 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, es trus 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 d ifferent 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 Endo crine Disruptor Screening Program (EDSP).Docket Number: EPA

- HQ

- OPP

- 2010

- 0692

www.regulations.gov

8 of 9 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 occurrin g 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

c hemical 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 relation ship 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 5 8 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 orde rs/data call

ins, 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 batt ery, 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) 5Docket Number: EPA

- HQ

- OPP

- 2010

- 0692

www.regulations.gov

9 of 9 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

.