United States Chemical Safety December 2010 

Environmental Protection and Pollution Prevention 

Agency (7510P) 

 

Benzoic Acid 

Summary Document: 

Registration Review 

December 2010 

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

www.regulations.gov

Benzoic Acid

Registration Review: Initial Docket

December 2010

Case # 5107

Approved By:

Jo Harrigan-Farrelly

irector, Antimicrobials Division

Date:

7 I

(2 /;5'/,Uj!tJ

2 of 16
Docket Number: EPA-HQ-OPP-2010-0692 

www.regulations.gov

TABLE OF CONTENTS 

Benzoic Acid Registration Review Team ............................................................................4 

I. Preliminary Work Plan .....................................................................................................5

II. Fact Sheet ......................................................................................................................11 

III. Summary of Anticipated Data Requirements ..............................................................15 

IV. Appendix A ..................................................................................................................16

________________________________________ 

Please Note 

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency's 

current position based on the following documents: 

1. Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the 

Benzoic acid Registration Review Decision Document. November 3, 2010 

2. Benzoic acid. Human Health Effects Scoping Document for the Registration Review 

Decision. October 19, 2010 

Additional supporting documents for benzoic acid may be found in the registration review docket

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

3 of 16 
Docket Number: EPA-HQ-OPP-2010-0692 

www.regulations.gov

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 

4 of 16 
Docket Number: EPA-HQ-OPP-2010-0692 

www.regulations.gov

I. Preliminary Work Plan -- Benzoic Acid 

Introduction:

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States generally must be registered by the U.S. 

Environmental Protection Agency (USEPA, EPA, or the Agency) based on scientific data 

showing that they will not cause unreasonable 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 

pesticides 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/registration_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 during 

this initial comment period, the Agency will develop and commit to a final work plan and 

schedule for the Benzoic Acid Case. 

Benzoic acid (PC Code 009101) is registered as an antimicrobial pesticide in one end-use 

product (EP), MICROL Preservative, registered to Petro-Canada Lubricants (EPA Reg. No. 

82076-1). MICROL Preservative is a soluble concentrate/solid (SC/S) containing 99.98% 

benzoic acid. Currently, there are no registered conventional pesticide uses and the only 

registered antimicrobial use is for the preservation of food-grade lubricating oils used in 

commercial food-handling establishments. 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). Human dietary exposure to residues of benzoic acid 

from pesticidal sources, however, is expected to be minimal compared to naturally-occurring 

levels in food (especially in fruits), as well as the direct food-additive uses, pharmaceutical uses, 

and cosmetic uses regulated by the Food and Drug Administration (FDA). Between 1989 and 

December 2005, there were no registered uses for benzoic acid as a pesticide. Because the 

current product (used in lubricating oil) was registered after the risk assessments were completed 

for the Benzoic Acid and Derivatives (Case 4013) Reregistration Eligibility Decision (RED), 

uses for benzoic acid were assigned to be reevaluated under Registration Review Case 5107. 

Derivatives of benzoic acid will be reevaluated under Registration Review Case 4013. 

Documents associated with the registration review of benzoic acid can be viewed at 

www.regulations.gov in docket EPA-HQ-OPP-2010-0692. Below is a summary of the issues 

relevant to the registration review case. 

5 of 16 
Docket Number: EPA-HQ-OPP-2010-0692 

www.regulations.gov

Anticipated Risk Assessment and Data Needs:

The Agency does not anticipate the need to conduct an ecological risk assessment. The Agency 

anticipates the need to conduct a human health risk assessment. The Agency anticipates needing 

additional data to conduct the registration review for benzoic acid. 

Ecological Risk: 

• No ecological risk assessment has been performed for benzoic acid. 

• 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. 

• The Agency does not anticipate the need to require additional ecological data at this 

time. 

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

dated November 3, 2010. 

Human Health Risk: 

• 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. 

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

support an occupational inhalation risk assessment to be conducted during the registration 

review of benzoic acid. 

o 875.2700 -- Product use information 

o 875.2800 -- Description of human activity 

• For more information, please refer to Benzoic acid. Human Health Effects Scoping 

Document for the Registration Review Decision,” dated October 19, 2010. 

Product Chemistry: 

6 of 16 
Docket Number: EPA-HQ-OPP-2010-0692 

www.regulations.gov

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

data to support an occupational inhalation risk assessment to be conducted during the 

registration review of benzoic acid. 

o 830.7520 -- Particle size distribution 

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

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

dated November 3, 2010. 

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 quantitative 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. 

Benzoic acid was 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 orders/data call-ins for all 

Registration Review cases, including those for which EPA has already opened a Registration 

Review docket for a pesticide active ingredient. 

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/. 

Timeline

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

registration review: 

Anticipated Schedule

7 of 16 
Docket Number: EPA-HQ-OPP-2010-0692 

www.regulations.gov

Activities Estimated Month/Year

Phase 1: Opening the docket 

Open Public Comment Period for Benzoic Acid Docket December 2010

Close Public Comment Period for Benzoic Acid Docket February 2011 

Phase 2: Case Development 

Develop Final Work Plan (FWP) June 2011 

Issue DCI June 2012 

Data Submission June 2013 

Open Public Comment Period for Preliminary Risk Assessments September 2014 

Close Public Comment Period for Preliminary Risk Assessments December 2014 

Phase 3: Registration Review Decision 

Open Public Comment Period for Proposed Reg. Review Decision March 2016 

Close Public Comment Period for Proposed Reg. Review Decision June 2016 

Final Decision and Begin Post-Decision Follow-up 2016 

Total (years) 6 

Guidance for Commenters:

The public is invited to comment on EPA’s preliminary registration review work plan and 

rationale. 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 benzoic 

acid registration review case. 

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 comment 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. 

Water Quality:

Benzoic acid is not identified as a cause of impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act, based on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=88

5. In addition, no Total Maximum Daily Loads (TMDL) have been developed for benzoic acid, 

based on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id

=885&p_pollutant_group_name=PESTICIDES. 

More information on impaired water bodies and TMDLs can be found at 

http://www.epa.gov/owow/tmdl/. The Agency invites submission of water quality data for this 

8 of 16 
Docket Number: EPA-HQ-OPP-2010-0692 

www.regulations.gov

pesticide. To the extent possible, data should conform to the quality standards in Appendix A of 

the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water 

Quality Data in OPP’s Registration Review Risk Assessment and Management Process (see: 

http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm), in order to ensure the 

data can be used quantitatively or qualitatively in pesticide risk assessments. 

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, 

and enforcement of environmental laws, regulations, and policies. 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 benzoic acid compared 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. 

Structure Activity Relationships: 

EPA must rely upon information of appropriate quality and reliability for each decision made by 

the Agency. In the Office of Pesticide Programs (OPP), the evaluation process for a pesticide 

chemical traditionally begins with the applicant’s submission of a set of studies conducted with 

the specific pesticide chemical of interest. The use of the results of such testing (measured data) 

is a logical, scientifically rigorous process that identifies the physical, chemical, and 

environmental fate properties of the pesticide, as well as the dose and endpoints at which an 

adverse effect can occur in various animal species. 

Today, there is significant interest in alternative techniques, i.e., techniques other than data 

generation that could significantly inform the Agency’s decision-making process. Recently, 

OPP has made increasing use of structure activity relationship (SAR) as part of its regulatory 

decision-making process. In the SAR process, a chemical's molecular structure is compared to 

that of other chemicals for which data are available. These structural similarities are then used to 

make predictive judgments about a chemical’s physical, chemical, and biological properties. 

Thus, the chemical’s physical, chemical, and biological properties are a function of (or directly 

related to) the chemical’s molecular structure. Quantitative SAR is referred to as QSAR. To 

develop a QSAR, a selected set of measured data on a single physical, chemical, or biological 

property is used to derive a model (an equation) to predict the value of that property. 

Since SAR assessments and QSAR modeling are another set of tools that are available to Agency 

scientists, OPP has begun a process shift that envisions shifting from the current study-by-study 

approach to an approach in which the use of predicted data, generated using validated models, is 

considered along with information from open literature and studies specifically generated under 

Part 161 requirements. All relevant information would be considered as part of a weight-of-theevidence evaluation. 

9 of 16 
Docket Number: EPA-HQ-OPP-2010-0692 

www.regulations.gov

At this time, EPA believes that for certain endpoints, especially physical/chemical and fate 

properties, that SAR and QSAR might be effectively utilized to fulfill these data requirements 

for many antimicrobial pesticide chemicals. When considering biological properties, at this 

time, EPA believes that SAR and QSAR can be most effectively utilized in the evaluation of 

chemicals that exhibit lower toxicity for human health and/or ecotoxicity parameters. This is 

appropriate because the risk assessment for lower toxicity chemicals can be stream-lined, i.e., a 

screening-level assessment procedure rather than multiple tiers of assessments with progressively 

more data requirements. 

If stakeholders believe that submission of predicted data can fulfill one of the data needs for the 

Benzoic Acid Case, then the Agency invites submission of this information. The submitter 

would be expected to supply a rationale describing the utility of the information and provide 

documentation on the scientific validity of the information. The determination that the predicted 

data fulfills the data requirement would be at the sole discretion of the Agency. Pre-submission 

consultation with the Agency is encouraged. 

Additional Information:

Stakeholders are also specifically asked to provide available information and data that will assist 

the Agency in refining the risk assessments. The Agency is interested in receiving the following 

information: 

1. Confirmation on the following label information: 

a. Sites of application 

b. Formulations 

c. Application methods and equipment 

d. Maximum application rates 

e. Frequency of application, application intervals and maximum number of 

applications 

f. Geographic limitations on use 

2. Use or potential use distribution 

3. Use history 

4. Usage/use information for non-agricultural uses (e.g., materials preservation) 

5. Typical application interval 

6. State or local use restrictions 

7. Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian 

and mammalian mortalities) not already reported to the Agency 

8. Monitoring data 

9. Structure Activity Relationships

Next Steps:

After the 60-day comment period closes in February 2011, the Agency will review and 

respond to any comments received in a timely manner, and then issue a Final Work Plan for the 

Benzoic Acid Case. 

10 of 16 
Docket Number: EPA-HQ-OPP-2010-0692 

www.regulations.gov

II. Fact Sheet 

Background Information:

• Active Ingredient: benzoic acid 

• Registration review case number for benzoic acid: 5107 

• PC Code: 009101 

• CAS#: 65-85-0 

• Technical registrants: Petro-Canada Lubricants, Inc. 

• First approved for use in a registered product: 1987 

• 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). 

• A Reregistration Eligibility Decision (RED) was completed for Benzoic Acid and 

Derivatives (Case 4013) in June 2007. Because the current product (used in lubricating 

oil) was registered after the risk assessments were completed for the Benzoic Acid and 

Derivatives (Case 4013) Reregistration Eligibility Decision (RED), uses for benzoic acid 

were assigned to be reevaluated under Registration Review Case 5107. Derivatives of 

benzoic acid will be reevaluated under Registration Review Case 4013. 

• Antimicrobials Division Chemical Review Manager (CRM): Seiichi Murasaki, 

murasaki.seiichi@epa.gov

• Antimicrobials Division Product Manager (PM): Velma Noble, noble.velma@epa.gov

Use & Usage Information:

• Antimicrobial use of benzoic acid is currently registered only for use as a preservative of 

food-grade lubricating oils in industrial settings. 

Ecological Risk Assessment Status:

Please refer to Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for 

the Benzoic acid Registration Review Decision Document, located in the docket, for a detailed 

discussion of the ecological risk assessments. 

• 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. 

Human Health Risk Assessment Status:

The following are key findings of the recent human health risk assessments for benzoic acid. 

Please refer to Benzoic acid. Human Health Effects Scoping Document for the Registration 

Review Decision, located in the docket, for a detailed discussion of the human health risk 

assessment. 

11 of 16 
Docket Number: EPA-HQ-OPP-2010-0692 

www.regulations.gov

Hazard Characterization: 

• Benzoic acid exhibits low to moderate acute oral toxicity (toxicity category III and IV) 

based on acute oral, dermal, and inhalation studies in animals. The soluble 

concentrate/solid (SC/S) is a severe eye irritant (Category I). 

• The carcinogenic potential of benzoic acid has been classified as Group D, not 

classifiable as to human carcinogenicity. 

Dietary (Food and Water): 

• 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 naturally-occurring levels in food 

(especially in fruits), as well as the direct food-additive uses, pharmaceutical uses, and 

cosmetic uses regulated by the FDA. 

• 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 discharge or disposal of treated lubricant into aquatic 

environments is expected to be minimal. 

Residential: 

• The product is registered 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: 

• 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. 

Occupational: 

• 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. 

• 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. 

12 of 16 
Docket Number: EPA-HQ-OPP-2010-0692 

www.regulations.gov

• 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 openpour method. 

• A 28-day rat inhalation toxicity study is available. 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, 

description of human activity, and particle size distribution data anticipated as needed 

have been received. 

• Current label instructions requiring that handlers wear protective eye covering are 

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

Cumulative: 

• 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. 

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. 

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). 

Data Call-In Status:

• There are no outstanding data call-in (DCI) requirements for benzoic acid. 

13 of 16 
Docket Number: EPA-HQ-OPP-2010-0692 

www.regulations.gov

Labels: 

Registered active products, including EPA registration numbers are provided in Table 1 below. 

For future reference, during registration review a list of product registration numbers will be 

included in the docket. Product registration labels may be obtained from the Pesticide Product 

Label System (PPLS) website at: http://oaspub.epa.gov/pestlabl/ppls.home. 

Table 1. Registered Active Products – Benzoic Acid 

Registration # Registration Name Company Name Formulation Type % A.I.

82076-1 MICROL 

Preservative

Petro-Canada Lubricants 

Division End-use product 99.98

 

14 of 16 
Docket Number: EPA-HQ-OPP-2010-0692 

www.regulations.gov

III. Summary of Anticipated Data Requirements – Benzoic Acid 

The table below summarizes anticipated data needs for benzoic acid in Section I of this 

document (Preliminary Work Plan), Summary of Product Chemistry, Environmental Fate, and 

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

acid. Human Health Effects Scoping Document for the Registration Review Decision. 

Table 2. Summary of Anticipated Data Requirements – Benzoic Acid 

Guideline 

Number Anticipated Data Requirement Test Material

Est. 

Timeframe 

(months) 

(Measured 

from DCI 

Receipt)

830.7520 Particle size distribution TEP 12

875.2700 Product use information TEP 12

875.2800 Description of human activity TEP 12

15 of 16 
Docket Number: EPA-HQ-OPP-2010-0692 

www.regulations.gov

16 of 16 

IV. Appendix A: Use Patterns – Benzoic Acid 

Use Site Formulation/ 

EPA Reg. no. 

Method of 

Application 

Application Rate/ 

No. of applications 

Materials Preservative 

Food Grade Lubricating 

Oils 

 Food use mineral oils 

Ready-to-Use 

Solution / 82076-1 

Open Pour 1.0% maximum