July 21 , 2015 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

MEMORANDUM 

SUBJECT: PC Code. 84400 I; Acetic Acid; Human Health Risk Assessment and 

Ecological Effects Assessment to Support Proposed Exemption from the 

Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide 

Formulations. 

All PC Code: 844001 DP Barcode: 

Decision No.: 

Regulatory Action: Inert 

Tolerance Exemption: 40 

CFR 180.940(b) 

Petition No: lN-1 0766 All CAS No: 64-19-7 

Inert Tracking No: N/A 

FROM: 

Through: 

TO: 

Chemistry, 

Lisa Austin, 

Jnert

Ph.D.

s and 

, Toxicol

Toxic

og

ology 

ist 

Assess

L 

ment Branch 

rA ~ (CIT AB) 

Registration Division (7505P) 

Kerry Leifer, Team Leader 

Chemistry, lnerts and Toxico 

Registration Division (7505P) 

PV Shah, Ph.D .. Branch Chief 

Chemistry, Inerts and Toxicology Assessment Branch (CIT AB) 

Registration Division (7505P) 
EXECUTIVE SUMMARY 

The EPA (Agency) received a petition (IN-1 0766) from Technology Sciences Group, fnc., 

(1 150 181

h Street, Suite 1000 Washington, DC 20036) on behalf of West Agro, Inc. (11100 North 

Congress Avenue. Kansas City, MO 64153) requesting that the Agency amend a tolerance 

exemption for usc of acetic acid (CAS Reg No. 64-19-7) as an inert ingredient to include use as 

an active ingredient promoter on dairy and food-processing equipment and utensils under 40 

CFR Part 180.940(b)(c) limited to 1200 ppm in end-use concentration. This request seeks to 

increase the current limit from 686 ppm to 1200 ppm for acetic acid under 40 CFR Part 

180.940(b). Acetic acid is currently approved as an inert ingredient under 40 CFR Part 

180.940(a) (limited to 290 ppm); l80.940(c) (limited to 686 ppm); 180.910 (no limitation); and 

180.930 (l imited to 0.5% of pesticide formulations). Also, it has an exemption from tolerance 

when used as a biochemical pesticide post-harvest on grains and hays for animal feed (40 CFR 

180.1258(a)) and when used as an herbicide. unintentional residues of acetic acid in non-target 

plants are also exempt from the requirement of a tolerance (40 CFR 180.1258(b)). lt is approved 

as an active ingredient for use on rights of ways, golf courses, open spaces, driveways and 

industrial sites at concentrations similar to that in vinegar to desiccate (dry out) plants. Further, 

it is considered Generally Recognized as Safe (GRAS) by the Food and Drug Administration. 

EPA published the notice of filing for this petition in the Federal Register on March 4, 2015 (80 

FR 11611 ). No substantial comments were received in response to this notice. 

In December 2014, the Agency issued a "Proposed Interim Registration Review Decision·· 

for acetic acid. This document determined that previous health assessments for acetic acid were 

sufficient for registration review and no human health risks of concern were identified. Since. 

new data were not submitted for acetic acid, this decision document re li es on the previous 

assessments conducted by the Agency. These assessments were included in the submitter's 

petition and were cited as such. They include: Acetic Acid and Salts Summary Document 

Registration Review (2007) and the American Chemical Council (ACC) Acetic Acid and Acetate 

Panels High Production Volume (HPV) Challenge Program (2001). 

Acetic acid is of low acute dermal and inhalation toxicity in rats. The acute dermal LDso was 

::: 1.060 mg!kg and the acute inhalation LCso was :::11.4 mg/L (equivalent to 2956 mg!kg). 

Dermal irritation was observed at > I 00 mg/kg in mice and was corrosive at > 60% in rabbits. It 

was also irritating in the eyes of rabbits. 

A 90-day oral toxicity study was available in rats administered acetic acid in drinking water. 

Although reduced body weight was observed at 390 mg/kg/day, the reduction in weight gain was 

likely attributed to reduced appetite and food consumption observed in the study. Therefore, this 

was not considered adverse effect. Rats treated for 8 months with 60 mg/kg bw/treatment (the 

only dose tested) of acetic acid (3 times/week) via gavage. exhibited hyperplasia in the 

esophagus and forestomach but did not have tumors. 

Several developmental toxicity studies were available with acetic acid. Fetal susceptibility 

was not observed in any of the studies. In rats, mice and rabbits maternal and developmental 

toxicity was not observed up to 1600 mg/kg/day. Reproduction toxicity studies were not 

available with acetic acid. 

2 
Tumors were not observed in rats treated for 8 months with 60 mg/kg bw/treatment of acetic 

acid in drinking water. 

Acetic acid was not mutagenic in an Ames test nor was it clastogenic in a cytogenetic assay 

with Chinese hamster ovary K I cells. 

In a toxicity study via the inhalation route of exposure, toxicity was manifested as decreased 

activity, behavioral changes and reduced work capacity following 22 days of treatment with 15 

ppm (equivalent to I 0 mg/kg/day) of acetic acid in rats and mice. The NOAEL vvas 11 ppm 

(equivalent to 7 mglkg/day). 

Neurotoxicity studies for acetic acid were not avail able for review. However, evidence of 

neurotoxicity was not observed in the submitted studies. 

Immunotoxicity studies for acetic acid were not available for review. However, increased 

spleen weight was observed at 23-3 1 ppm (equivalent to 15-19 mg/kg/day) of acetic acid in a 

toxicity study in rats via the inhalation route of exposure. However, these effects are not due to 

an immunotoxic response but due to red blood cell destruction. Therefore, there is no concern 

for potential immunotoxicity. ln addition, according to the American Conference of 

Governmental Industrial Hygenists, Inc. (ACGlH), the threshold limit value (TL V) for 

occupational exposure to acetic acid is I 0 ppm via inhalation. Based on the requested use 

pattern, occupational inhalation exposure is not expected. With regard to residential uses, 

inhalation exposure to acetic acid would be far less than the established TL V and is therefore not 

of concern. 

Acetic acid undergoes dissociation to the acetate anion and the 11+ cations in aqueous media 

at pHs commonly found in the environment. Also, it is a naturally-occurring substance in plants 

and animals. In aerobic metabolism, acetic acid (as acetate) is a metabolite that combines with 

Co-enzyme A to form acetyl Co-A which subsequently enters into the Citric Acid Cycle, a 

common metaboli c pathway in which food molecules are broken down to fonn energy. A major 

function ofthe Citric Acid Cycle is the oxidation of acetate. In animals. acetate is obtained from 

the breakdown of glucose molecules. 

Based on the widespread presence of acetic acid in human foods, the fact that it is a 

normal metabolite in humans and animals, its status as a substance that is considered Generally 

Recognized as Safe (GRAS) by the Food and Drug Administration, no toxicological endpoint of 

concern, its regulatory history and no new toxicological data to indicate concern regarding 

previous decisions a qualitative assessment was appropriate of all pathways of human exposure 

(food, drinking water, and residential). 

Occupational exposure was qualitatively assessed based on the regulatory history of acetic 

acid and no new toxicological data to indicate concern regarding previous decisions. 

Acetic acid is not expected to be toxic to aquatic organisms, terrestrial mammals and birds. 

It does not persist in the environment. 

3 
Taking into consideration all available infom1ation on acetic acid. EPA concludes that there 

is a reasonable certainty that no harm will result to the general population or to infants and 

children from aggregate exposure to acetic acid. Therefore, the amendment of an exemption 

from tolerance under 40 CFR 180.940(b) and (c)for residues of acetic acid as an inert ingredient 

in pesticide formulations used on dairy and food-processing equipment and utensils to allow for 

a limitation of 1200 ppm in the end-product formulation can be considered safe under section 

408 of the FFDCA. 

1. BACKGROUND 

The EPA received a petition (IN-I 0766) from TechJ1ology Sciences Group, Inc., (1150 18111 

Street. Suite 1000 Washington, DC 20036) on behalf of West Agro, Inc. ( 11100 North Congress 

Avenue, Kansas City, MO 64153) requesting a tolerance exemption for the use of acetic acid 

(CAS Reg No. 64-19-7) as an inert ingredient to include use as an active ingredient promoter on 

dairy and food-processing equipment and utensils under 40 CFR Part 180.940(b) and (c) limited 

to 1200 ppm in end-use concentration. This request seeks to increase the current limit from 686 

ppm to 1200 ppm for acetic acid under 40 CFR Part 180. 940(b ). EPA published the notice of 

filing for this petition in the Federal Register on March 4. 2015 (80 FR 11611). o substantial 

comments were received in response to this notice. 

Acetic acid is currently approved as an inert ingredient under 40 CFR Part 180.940(a), 

limited to 290 ppm and 180.910 and 180.930. limited to 0.5%. It has an exemption from 

tolerance when used post-harvest on grains and hays ( 40 CFR 180.1258(a)) and unintentional 

residues of acetic acid in non-target plants as a result of its herbicidal use are also exempt from 

the requirement of a tolerance (40 CFR 180.1258(b)). It is approved as an active ingredient for 

use on rights of ways, golf courses, open spaces, driveways and industrial sites at concentrations 

similar to that in vinegar to desiccate (dry out) plants. Jt is considered Generally Recognized as 

Safe (GRAS) by the Food and Drug Administration. Further, acetic acid can be found in 

numerous consumer products at concentrations of 3-8%. 

This document provides an assessment of the risk to human health and the environment for 

acetic acid when used as an inert ingredient in in pesticide formulations used on dairy and foodprocessing equipment and utensils at 1200 ppm. Information from the submitter's petition is 

reproduced and referenced in this assessment. They include EPA documents (2008. 20 I 0), 

American Chemical Council (ACC) Acetic Acid and Acetate Panels High Production Volume 

(HPV) Challenge Program (2001a and b). The Agency"s most recent document on acetic acid 

was also reproduced in this assessment (Proposed Interim Registration Review Decision). 

2. Inert Ingredient Profile 

Some of the physical and chemical characteristics of acetic acid along with its structure 

and nomenclature, are found in Table 1. 

Table 1. Physical and Chemical Properties of Acetic Acid 

4 
Parameter Value Source 0 

Structure A OH 

CAS # 64-19-7 

Molecular Weight {g/mol) 60.05 

Common Names Acetic Acid 

Physical State Liquid 

Melting Po MRID 49160501 int (0C) 16.7 

Boilin?, Point (0C) 118.1 

pH@.)0°C 2.5 for 50 giL solution 

Vapor Pressure (mm Hg @ 11.4 20°C) 

Partition Coefficient (Log Kow) -0.17 

Water Solubility (g/L at 23°C) 50 

3. Hazard Assessment 

The following studies were reproduced and referenced from the petition submitted by the 

registrant, EPA document, Acetic Acid and Salts Summary Document Registration Review 

(2007) and American Chemical Council (ACC) Acetic Acid and Acetate Panels High Production 

Volume (HPV) Challenge Program (200 1 ). 

Acute Toxicity Studies 

Table 2 Acute Toxicity Profile of Acetic Acid 

Guideline No. Study Type Results 

870.1000 Acute-Oral-rats LD50> 3.3 10 mglkg 

870. 1000 Acute-Oral-m icc LD50> 4.960 mg/kg 

870.1100 Acute-Dem1al-rats LD50> 1.060 mg/kg 

870.1 100 Acute-Dem1al-mice > I 00 mglkg in mice produced 

irritation 

870.1200 Acute-Inhalation-rats LC50> 11.4 mg/L(cquivalent to 2956 

mglkg) 

870.2400 Acute-Eye Irritation- Irritati ng rabbits 

870.2500 Acute-Dermal Corrosive at >60% 

Irritation-rabbits 

5 
Repeated Dose Toxicitv studies 

90-Dav oral-Drinking Water-Rat 

A 90-day feeding study in rats was conducted with acetic acid. Rats administered up to 390 mg 

acetic acid/kg/day in drinking water for 2 to 4 months had a LOAEL of 390 mg/kg/day (based on 

weight loss) and a NOAEL of 195 mg/kg/day. (Hummel, S .. 2/28/07. 0344771 ). The reduction in 

weight gain was likely attributed to reduced appetite and food consumption observed in the 

study. Therefore, this effect was not considered adverse and the NOAEL is 390 mglkg/day. 

Developmental Toxicitv Study- Rabbit 

In a developmental toxicity study in albino Wistar rats, mated female rats were administered 

acetic acid (5%) via gavage at 0, 16, 74,345 and 1600 mg/kg/day on gestation days 6-16. On 

day 20, Caesarean sections were performed. The number of implantation sites. resorption sites 

and live and dead fetuses were similar to the controls. Neither maternal nor fetal treatment 

related effects were observed up to 1600 mg/kg/day, the highest dose tested (HPV, 2001). 

In a developmental toxicity study in CO-l mice, mated female mice were administered acetic 

acid (5%) via gavage at 0, 16, 74. 345 and 1600 mglkg/day on gestation days 6-16. On day 17. 

Caesarean sections were perf01med. The number of implantation sites, resorption.sites and live 

and dead fetuses were similar to the controls. Neither maternal nor fetal treatment related effects 

were observed up to 1600 mg/kg/day, the highest dose tested (HPV. 200 I). 

In a developmental toxicity study in Dutch-belted rabbits, artificially inseminated female 

rabbits were administered acetic acid (5%) via gavage at 0, 16, 74, 345 and 1600 mg/kg/day on 

gestation days 6-19. On day 29, Caesarean sections were performed. The number of corpora 

lutea, implantation sites, resorption sites and live and dead fetuses were similar to the controls. 

Neither maternal nor fetal treatment related effects were observed up to 1600 mg/kg/day, the 

highest dose tested (HPV, 2001). 

8-Month-Oral Toxicitv/Carcinogenicity Studv-Rat 

In an 8-month oral toxicity study in rats, the carcinogenic potential of acetic acid was 

evaluated. In this study, nine outbred white male rats were administered 0.5ml of 3% water 

solution of acetic acid (equivalent to 60 mg/kg/treatment) via gavage three times per week for 

eight months. Rats were given N-nitrososarcosine ethyl ester (NSEE; a known carcinogen) alone 

and NSEE with an acetic acid solution, or the acetic acid solution alone. Rats treated with the 

carcinogen and NSEE had high incidences of pre-neoplastic lesions in the esophagus and 

forestomach as well as benign tumors, carcinomas and squamous cell cancer. Rats treated with 

acetic acid and NSEE had an increase in the number of benign and malignant tumors and 

6 
carcinomas in the esophagus. Rats treated with acetic acid alone had hyperplasia in the 

esophagus and forestomach but did not have tumors (HPV, 2001). 

Genotoxicitv Studies 

In a bacterial reverse mutation assay Salmonella typhimurium strains T A 98, T A I 00, T A 

1535, TA 97 and TA 1537 were treated with acetic acid at concentrations of 100, 333, 1000 

3333, 6666 and 10,000 !lg/plate with and without metabolic activation. No revertant colonies 

were observed (HPV, 2001). 

In a cytogenetic assay, Chinese hamster ovary K I cells were treated with acetic acid at 

concentrations up to l6mM. Acetic acid was not clastogenic (HPV, 2001). 

Inhalation Toxicity Studv 

Rats and mice were treated with 11-1 5 ppm (equivalent to7- 10 mg/kg/day) of acetic acid via 

the inhalation route of exposure for 3-35 days. Groups of I 0 rats and mice (sex unknown) were 

exposed to 15 ppm (equivalent tolO mg/kg/day) of acetic acid for 22 days or more exhibited 

decreased activity, behavioral changes and reduced work capacity. At 23-3 1 ppm (equivalent to 

15-19 mg/kg/day), animals exhibited growth, increased spleen weight. an increase of the level of 

iron stored in the spleen, signs of kidney damage and increased kidney weights. The LOAEL 

was 15 ppm (equivalent tolO mg/kg/day) based on decreased activity, behavioral changes and 

reduced work capacity. The NOAEL was II ppm (equivalent to7 mg/kg/day) (HPV. 2001). 

Metabolism 

Acetic acid undergoes dissociation to the acetate anion and the H+ cations in aq ueous media 

at pHs commonly found in the environment. Also, it is a naturally-occurring substance in plants 

and animals. In aerobic metabo lism, acetic acid (as acetate) is a metabolite that combines with 

Co-enzyme A to form acetyl Co-A which subsequently enters into the Citric Acid Cycle, a 

common metabolic pathway in which food molecules are broken down to form energy. A major 

function of the Citric Acid Cycle is the oxidation of acetate. In animals. acetate is obtained from 

the breakdown of glucose molecules. 

Table 3. Toxicology Profile for Acetic Acid 

Study Type Doses Results 

3-35 Day - inhalation -rat 11-35 ppm (equivalent to7- The OAEL = I I ppm (7 mg/kg/day) 

23 mglkg/day) The LOJ\EL = 15 ppm (equivalent to I 0 mg/kg/day) based 

on decreased activity, behavioral changes and reduced work 

capacity. 

7 
Table 3. Toxicology Profile fo r Acetic Acid 

Study Type Doses Results 

90 day oral - F344 rats- 195 and 390 mg/kg/day NOA EL = 390 mg/kg/day drinking water 

LOAEL was not established. 

8-MonthOral/ 60 mg/kg/treatment The NOAEL was not established. Carcinogenicity 

Toxicity Study-Rat-gavage LOAEL = 60 mg/kg/treatment based on hyperplasia in the 

(equivalent to96 days) esophagus and forestomach. 

No tumors were observed. 

Developmenta l toxicity-rat 0. 16, 74. 345 and 1600 The NOAEL = 1600 mglkg/day. 

mglkg bw/day The LOAEL was not established. 

Developmenta l toxicity- 0, 16, 74, 345 and 1600 The NOAEL = 1600 mg/kg/day. 

mouse rnglkg/day The LOAEL was not established. 

Developmental toxicity- 0, 16, 74, 345 and 1600 The NOAEL = 1600 mg/kg/day. 

rabbit mglkg/day The LOAEL was not established. 

Ames assay I 00. 333, I 000 3333, 6666 Negative 

and I 0,000 !Jg/plate 

Cytogenetic assay :;:16mM Negative 

5. Toxicity Endpoint Selection 

Based on the widespread presence of acetic acid in human foods, the fact that it is a 

normal metabolite in humans and animals, its status as a substance that is considered Generally 

Recognized as Safe (GRAS) by the Food and Drug Administration, no toxicological endpoint of 

concern, its regulatory history and no new toxicological data to indicate concern regarding 

previous decisions a qualitative assessment was appropriate of all pathways of human exposure 

(food, drinking water, and residential). 

6. Special Considerations for Infants and Children 

As part of its qualitative assessment, the Agency did not use safety factors for assessing risk, 

and no additional safety factor is needed for assessing risk to infants and children. Based on the 

lack of toxicity of acetic acid in the available studies and its chemical properties, EPA has 

concluded that there are no toxicological endpoints of concern for the U.S. population, including 

infants and children. 

8 
7. Exposure Assessment 

Dietary Exposure 

In evaluating dietary exposure to acetic acid. EPA considered exposure under the 

petitioned for exemptions from the requirement of a tolerance. Since no endpoint of concern was 

identified for the acute and chronic dietary exposure assessment and short and intermediate 

dermal and inhalation exposure, a quantitative risk assessment for acetic acid is not necessary. 

Cancer. Acetic acid is not expected to be carcinogenic since there was no evidence of 

carcinogenicity in an oral toxicity study in rats and there was a negative response for 

mutagenicity. Since the Agency has not identified any concerns for carcinogenicity relating to 

acetic acid a cancer dietary exposure assessment was not performed. 

8. Residential (Non-Occupational) Exposure/Risk Characterization 

Acetic acid may be used in pesticide and nonpesticide products that may be used around the 

home. It is registered as a 6% active ingredient liquid formulation for consumer use as a home 

garden non-selective herbicide in non-food crop areas. Also, the homeowner use product 

contains 6% acetic acid, which is approximately the same concentration as household vinegar. 

Therefore, based on the widespread presence of acetic acid in human foods, the fact that it is a 

normal metabolite in humans and animals, its status as a substance that is considered Generally 

Recognized as Safe (GRAS) by the Food and Drug Administration, no toxicological endpoint of 

concern, its regulatory history and no new toxicological data to indicate concern regarding 

previous decisions a qualitative assessment was conducted for residential exposure. 

9. Occupational Exposure/Risk Pathway 

The Agency believes that increasing the limit from 686 ppm to 1200 ppm for acetic acid 

under 40 CFR Part 180.940(b) and (c) wil l not significantly/measurably increase occupational 

exposure. In view of the regulatory history of acetic acid, i.e., approved use Lmder 40 CFR 

§ 180.940 (a), § 180.910 and § 180.930 and no new toxicological information to indicate 

otherwise, it is not necessary to quantitatively assess occupational exposure. 

10. Cumulative Exposure: 

Section 408(b)(2)(D)(v) ofFFDCA requires that when considering whether to establish. 

modify, or revoke a tolerance. the EPA consider "available information" concerning the 

cumulative effects of a particular pesticide's residues and "other substances that have a common 

mechanism of toxicity." Unlike other pesticides for which EP 1\ has followed a cumulative risk 

approach based on a common mechanism of toxicity. EPA has not made a common mechanism 

9 
of toxicity finding as to acetic acid and any other substances and, this material does not appear to 

produce a toxic metabolite produced by other substances. For the purposes of this tolerance 

action, therefore, EPA has not asswned that acetic acid has a common mechanism of toxicity 

with other substances. For information regardi ng EPA's efforts to determine which chemicals 

have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals. 

see the policy statements released by EPA's Office of Pesticide Programs concerning common 

mechanism determinations and procedures for cumulating effects from substances found to have 

a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/. 

11. Ecotoxicity and Environmental Fate 

Based on the "Acetic Acid and Sodium Diacetate Proposed Interim Registration Review 

Decision (Docket Nwnber EPA-HQ-OPP-2008-001 6), acetic acid is not expected to be toxic to 

aquatic organisms, terrestrial mammals and birds. It does not persist in the environment. 

12. Environmental Justice 

Potential areas of environmental justice concerns. to the extent possible, were considered in 

this human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal 

Actions to Address Environmental Justice in Minority Populations and Low-Income 

Populations," http://www.eh.doe.gov/oepa/guidance/justice/eo 12898.pdf). 

As a part of every pesticide risk assessment, OPP considers a large variety of consumer 

subgroups according to well-established procedures. In line with OPP policy, HED estimates 

risks to population subgroups from pesticide exposures that are based on patterns of that 

subgroup's food and water consumption, and activities in and around the home that involve 

pesticide use in a residential setting. Extensive data on food consumption patterns are compiled 

by the USDA under the Continuing Survey of Food Intake by Individuals (CSFU) and are used 

in pesticide risk assessments for all registered food uses of a pesticide. These data are analyzed 

and categorized by subgroups based on age, season of the year, ethnic group, and region of the 

country. Additionally, OPP is able to assess dietary exposure to smaller, specialized subgroups 

and exposure assessments are performed when conditions or circumstances warrant. Whenever 

appropriate, non-dietary exposures based on home use of pesticide products and associated risks 

for adult appli cators and for toddlers, youths, and adults entering or playing on treated areas 

postappli cation are evaluated. Further considerations are currently in development as OPP has 

committed resources and expertise to the development of specialized software and models that 

consider exposure to bystanders and farm workers as well as lifestyle and traditional dietary 

patterns an1ong specific subgroups. 

13. Risk Characterization 

The EPA (Agency) received a petition (TN-I 0766) from Technology Sciences Group, Inc., 

(1150 18111 Street, Suite 1000 Washington, DC 20036) on behalf of West Agro, Inc. (111 00 North 

Congress Avenue. Kansas City, MO 64153) requesting a tolerance exemption for use of acetic 

acid (CAS Reg No. 64-1 9-7) as an inert ingredient limited to 1200 ppm in pesticide formulations 

10 
used on dairy and food-processing equipment and utensils under 40 CFR Part 180.940(b) and (c). 

This request seeks to increase the current limit from 686 ppm to 1200 ppm for acetic acid under 

40 CFR Part 180.940(b)(c). Acetic acid is currently approved as an inert ingredient under 40 

CFRPart 180.940(a), 180.910, 180.930,40CFR 180.1258(aandb). Itisapprovedasanactive 

ingredient. Further, it is considered Generall y Recognized as Safe (GRAS) by the Food and 

Drug Administration. 

Acetic acid is of low acute dermal and inhalation toxicity in rats. It causes dermal irritation 

in mice and is corrosive in rabbits. It was also irritating in the eyes of rabbits. Toxicity was not 

observed up to 390 mglkg/day in a 90-day oral toxicity study. Fetal susceptibility was not 

observed in developmental studies in rats, mice and rabbits. It is not gcnotoxic or mutagenic. lt 

is not carcinogenic, neurotoxic or immunotoxic. 

Acetic acid Lmdergoes dissociation to the acetate anion and the H+ cations in aqueous media 

at pHs commonly found in the environment. Also, it is a naturally-occurring substance in plants 

and animals. 

Based on the widespread presence of acetic acid in human foods, the fact that it is a nom1al 

metabolite in humans and animals, its status as a substance that is considered Generally 

Recognized as Safe (GRAS) by the Food and Drug Administration, no toxicological endpoint of 

concern, its regulatory history and no new toxicological data to indicate concern regarding 

previous decisions a qualitative assessment was appropriate of all pathways of human exposure 

(food, drinking water, and residential). 

Neither aggregate exposure nor occupational exposure is of concern. 

Acetic acid is not expected to be toxic to aquatic organisms, terrestrial mammals and birds. 

It does not persist in the environment. 

Taking into consideration all available information on acetic acid, EPA concludes that there 

is a reasonable certainty that no harm will result to the general population or to infants and 

children from aggregate exposure to acetic acid. Therefore, the amendment of an exemption 

from tolerance under 40 CFR 180.940 (b) and (c) for residues of acetic acid as an inert ingredient 

in pesticide formulations used on dairy and food-processing equipment and utensils to allow for 

a limitation of 1200 ppm in the end-product formulation can be considered safe under section 

408 of the FFDCA. 

11 
REFERENCES 

American Chemistry Council Acetic Acid and Salts Panel. 20Q I, U.S. 

High Production Volume (HPV) Chemical Challenge Program: Robust summaries for 

Acetic acid and salts category. 

EPA. Hummel, S. (2007) Memorandum: Acetic Acid Registration Review Case No. 400 I.DP 

Barcode D344 771. November 28. 2007. 

U.S. Environmental Protection Agency (EPA), 2008. Acetic acid and salts summary document. 

Registration Review: Initial Docket, EPA-HQ-EPA- OPP-2008-00 16. Case #400 I. 

www.regu lations.gov. 

U.S. Environmental Protection Agency (EPA). 20 14. Acetic Acid and Sodium Diacetate Proposed 

Interim Registration Review Decision. Registration Review: Initial Docket, EPA-HQ-EPA- OPP2008-00 16. Case #400 I, 

www.regulations.gov. 

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