40736 Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Rules and Regulations 

[FR Doc. 2010–17156 Filed 7–13–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0561;FRL–8833–8] 

Acetic Acid; Exemption from the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

existing tolerance exemption for acetic 

acid by establishing an exemption from 

the requirement of a tolerance for 

residues of acetic acid, also known as 

vinegar in or on all food crops resulting 

from unintentional spray and drift to 

non-target vegetation including nonfood, food and feed crops when used as 

a non-selective contact herbicide spray. 

SummerSet Products c/o SciReg, Inc. 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of acetic acid, also known 

as vinegar. 

DATES: This regulation is effective July 

14, 2010. Objections and requests for 

hearings must be received on or before 

September 13, 2010, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0561. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Cheryl Greene, Biopesticides and 

Pollution Prevention Division (7511P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–0352; e-mail address: 

greene.cheryl@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a(g), any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0561 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before September 13, 2010. Addresses 

for mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2010–0561, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of November 

19, 2008, (FR 69635) (FRL–8389–6), 

EPA issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 8F7319) 

by SummerSet Products c/o SciReg, 

Inc., 130 Columbia Court, Chaska, MN 

55318. The petition requested that 40 

CFR part 180 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of acetic acid. This notice referenced a 

summary of the petition prepared by the 

petitioner SummerSet Products, which 

is available in the docket, http:// 

www.regulations.gov. One anonymous 

comment was received on the notice of 

filing. However, EPA was unable to 

address the comment because it was not 

specific to this action, focusing instead 

on the registration of pesticides 

generally, and therefore was not a 

significant comment. 


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Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Pursuant to 

section 408(c)(2)(B) of FFDCA, in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in section 

408(b)(2)(C) of FFDCA, which require 

EPA to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue. . . .’’ 

Additionally, section 408(b)(2)(D) of 

FFDCA requires that the Agency 

consider ‘‘available information 

concerning the cumulative effects of a 

particular pesticide’s residues and other 

substances that have a common 

mechanism of toxicity’s. 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness, and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. 

Acetic acid is a substance found or 

produced naturally in most plants and 

animals, including primates and 

humans. It is also naturally produced 

during the fermentation process in a 

wide range of foods. In plants and 

animals, it is generally produced 

biologically by bacteria from the genus 

Acetobacter. Acetic acid has a 

fundamental role in cellular 

metabolism, particularly in the 

tricarboxylic acid cycle, also known as 

the citric acid (Ref. 1.) or krebs cycle 

(Ref. 2.), which is the chemical activity 

in all cells that utilize oxygen as part of 

their respiration process. The krebs 

cycle is carried out in the mitochondria 

of the cells of plants and animals 

including humans. Acetic acid plays a 

key role in the production of carbon 

dioxide and is a chemical rich in 

adenosine triphosphate (ATP). Acetic 

acid occurs naturally in many 

commonly consumed food items such as 

coffee, chick peas, edible plants, brown 

sugar, fruits, and vegetables where it 

forms during post-harvest fermentation. 

As an organic chemical, acetic acid is 

readily metabolized by the tissues of the 

body and is used in plants and animals 

to synthesize proteins, carbohydrates 

and fatty acids. In animals, including 

humans, acetic acid is produced 

naturally as consumed sugars and 

alcohol containing foods or liquids such 

as alcoholic beverage undergo 

fermentation. 

Acetic acid has been used as a food 

additive in most cultures throughout 

recorded history. Historical reports 

suggest that the first dietary 

consumption of acetic acid was in wine, 

beer and similar brewed beverages and 

fermented food items such as 

sauerkraut. Acetic acid also has a long 

history of use as a food additive. Acetic 

acid is a component of white distilled 

vinegar at 4%. In the form of vinegar, it 

is historically consumed in a wide range 

of commonly used condiments such as 

food seasonings, pickled food items, 

dried, preserved, canned and processed 

fruits and vegetables. It is also added to 

or found naturally in many dairy based 

foods including yogurt, chocolate milk 

and eggnog. It is included as an additive 

in many contemporary common foods 

including breakfast cereals, processed 

meats, prepared table top sweeteners, 

sports and energy drinks (CODEX 

GSFA, 2009) (Ref. 3.) and is used in 

pharmaceutical products such as 

antibiotics, antibacterials and 

antimicrobials. Acetic acid is also the 

main acid in vinegars, and it is the acid 

in vinegar that gives vinegar its 

characteristic odor. In commonly 

consumed vinegars such as white 

(distilled), cider, balsamic, malt, red 

wine, white wine, rice and sherry the 

percentage of acetic acid generally 

ranges between 3% and 8%. The Food 

and Drug Administration (FDA) 

classifies acetic acid as ‘‘Generally 

Recognized as Safe (GRAS)’’ under 21 

CFR 184.1005 as a direct food substance 

and under 21 CFR 582.1005 as a general 

purpose food additive. 

As a pesticide, acetic acid is 

registered for use as a non-selective 

contact herbicide for combating a wide 

range of weeds and some grasses. Upon 

contact with targeted weed and weed 

grasses, acetic acid destroys or damages 

the cell membrane of the plants which 

causes rapid dehydration of the plant 

tissues. This process is called ‘‘burnout’’ 

or ‘‘burndown’’ and can result in the 

death of the targeted plant or injury 

sufficient to slow the growth and 

reproduction of the targeted plant. 

In a final rule dated August 3, 2005, 

(70 FR 44483) (FRL–7717–2), EPA 

established an exemption from the 

requirement of a tolerance for residues 

of acetic acid when used as an active 

ingredient as a preservative on postharvest agricultural commodities 

intended for animal feed, including 

alfalfa, barley grain, bermuda grass; 

bluegrass, brome grass, clover, corn 

grain, cowpea hay, fescue, lespedeza, 

lupines, oat grain, orchard grass, peanut 

grass, Timothy, vetch, and wheat grain, 

or commodities described as grain or 

hay. Acetic acid is also approved for use 

on growing crops or raw agricultural 

commodities after harvest as an inert 

ingredient in pesticide products under 

40 CFR 180.1258. 

In support of the request to amend the 

existing exemption from the 

requirement of a tolerance, the Agency 

has reviewed all information submitted 

in support of this action. This petition 

is supported by information from open 

scientific literature and cited studies 

which are discussed in detail in this 

unit. When used as an indirect spray to 

control weeds and weed grasses 

according to the required label 

instructions, significant dietary residues 

of acetic acid are unlikely because direct 

exposure to food plants would be 

accidental or due to spray drift. 

Additionally, acetic acid rapidly 

biodegrades in the environment; it is 

non-toxic at pesticidal use 

concentrations; it is readily metabolized 

in the body; it is ubiquitous in food and 

the environment. Moreover, pesticidal 

uses of acetic acid are not expected to 

contribute significantly to the overall 

exposure of the general population, and 

information from the open literature 

indicates that acetic acid has little or no 

toxicity from an acute oral perspective 

(toxicity category III; median lethal dose 

(LD50 3,310 milligrams/kilogram (mg/ 

kg). (Ref. 4.) 

A. Acute Toxicity 

Acute toxicity information submitted 

to support the exemption from the 

requirement of a tolerance for acetic 


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acid confirms a low toxicity profile and 

reflects the Agency’s findings that acetic 

acid poses no significant human health 

risk with regard to food commodities. 

As a biochemical pesticide, products 

containing acetic acid would be used to 

control herbaceous broadleaf weeds and 

weed grasses that may damage or 

otherwise compromise the production 

of food crops. Products containing 

acetic acid are not intended for direct 

use on food crops. Moreover, any food 

crops exposed to acetic acid when used 

as a biochemical pesticide would be 

destroyed or significantly damaged. 

Such exposure would most likely be 

accidental or from spray drift and would 

render the plant unsuitable or less 

suitable for marketing. The low 

toxicological profile of acetic acid when 

used as an herbicide provides additional 

justification for this exemption from the 

requirement of a tolerance. Further, 

published literature (discussed in this 

unit) concerning low toxicity and the 

extensive history of acetic acid used in 

foods supports this exemption from the 

requirement of a tolerance. 

The primary routes of exposure to the 

general population have been 

determined to be through consumption 

of food and inhalation of air in 

workplaces. (Ref. 5.) 

1. Acute oral toxicity. The acute oral 

median LD50 for acetic acid in rats was 

greater than 3,310 mg/kg in rats and 

4,960 mg/kg in mice, which confirmed 

negligible toxicity through oral 

exposure. (Ref. 6.) The lowest observed 

adverse effect level (LOAEL) was 

determined to be 390 mg/kg and the no 

observed adverse effect level (NOAEL) 

was determined to be 195 mg/kg (Ref. 

7.) Acedic acid is a toxicity category III 

for acute oral toxicity. 

2. Acute dermal toxicity.The acute 

dermal LD50 for acetic acid in rats was 

1,060 mg/kg, (MRID 47330503) which 

confirmed moderate dermal toxicity, 

(MRID 47330503) the requirement of 

sub-acute toxicity data was waived 

because the use pattern and personal 

protection equipment (PPE) 

requirements of products containing 

acetic acid mitigate any risk from 

dermal exposure. Specifically, acetic 

acid as a biopesticide is only intended 

for use in spray products formulated for 

use as contact herbicides on broadleaf 

weeds and grasses; the Agency requires 

appropriate signal word (DANGER) and 

corresponding precautionary language 

on all labels containing acetic acid as a 

biochemical pesticide; and the Agency 

requires all applicators and handlers of 

such products to wear PPE that includes 

protective eyewear, long-sleeved shirt, 

long pants, socks and shoes. Given these 

considerations, the Agency believes that 

repeated dermal and inhalation 

exposure is not expected to occur. 

Acetic acid is a toxicity category II for 

acute dermal toxicity. 

3. Acute inhalation toxicity. The acute 

inhalation median LC50 was greater than 

11.4 milligrams per liter (mg/L) in rats 

and showed little to no inhalation 

toxicity or irritation (MRID 47330503). 

Acetic acid is toxicity category IV for 

acute inhalation toxicity. 

4. Primary eye irritation. A primary 

eye study showed significant potential 

for eye irritation. Eye corneal damage 

can occur from exposure to acetic acid 

and clarity of vision is not reversed 

within seven days (MRID 47330503). As 

such, the Agency has determined that 

acetic acid is Toxicity Category I for 

acute eye irritation. (PPE requirements 

of products containing acetic acid will 

mitigate any risk associated with the 

products). 

5. Acute dermal/skin sensitization. 

An acute dermal irritation/skin 

sensitization study showed that acetic 

acid is corrosive at very high (60%) 

concentrations (MRIDs 47330503) and 

(47330504). However, due to the use 

pattern and PPE requirements of 

biopesticidal products containing acetic 

acid (see Unit III.A.2., in this unit, 

regarding the use pattern and PPE 

requirements), and a required default 

restricted-entry interval (REI) of 48 

hours following application of products 

containing acetic acid, exposure risks 

associated with products containing 

acetic acid will be mitigated. Acetic acid 

is a Toxicity category I for acute dermal 

irritation/skin sensitization. 

B. Subchronic Toxicity 

Based on its acute toxicity profile, use 

pattern and biodegradation properties, 

residues of acetic acid are not expected 

to result in significant dietary exposure 

beyond the levels expected in 

background dietary exposures. 

Nonetheless, a subchronic oral, dermal 

and inhalation toxicity study satisfied 

the data requirements for subchronic 

toxicity and indicated that acetic acid 

has no subchronic toxicological effect. 

1. 90–day oral toxicity. A 90–day oral 

toxicity study (Ref. 8.) found no 

toxicological effects regarding mortality, 

clinical observations, neurotoxicity 

assessment, hematology, clinical 

chemistry, organ weights, and 

macroscopic or microscopic 

observations. Weight loss was observed 

in test subjects administered up to 390 

mg/kg body weight (bw/day) acetic acid 

in drinking water for 2-4 months. The 

reduction in weight gain is likely 

attributed to reduced appetite and food 

consumption observed in the study. No 

other effects were reported. The LOAEL 

was determined to be 390 mg/kg bw/ 

day, and the NOAEL was determined to 

be 195 mg/kg bw/day. 

2. 90–day dermal toxicity. 

Requirement of a 90–day dermal 

toxicity study has been waived. 

Considering the use pattern and PPE 

requirements of pesticide products 

containing acetic acid (see Unit III.A.2., 

in this unit, regarding the use pattern 

and PPE requirements), repeated dermal 

and inhalation exposure is not expected 

to occur. Additionally, the Agency does 

not expect significant dermal exposure 

since uses of acetic acid as a contact 

biopesticide will not involve purposeful 

application to the skin, nor will it result 

in prolonged dermal exposure to the 

product when label directions are 

followed. Moreover, acute toxicity 

testing of the two proposed end-use 

products in which acetic acid will be 

used as an herbicide have indicated that 

the products are non-irritating to 

slightly-irritating to the skin. 

Applicators are required to wear 

protective eye-wear, long-sleeved shirts, 

long pants, socks and shoes. 

Additionally, a REI of 48 hours has been 

added to these labels. 

3. 90–day inhalation toxicity. 

Requirements for a 90–day inhalation 

toxicity study have also been waived. 

Herbicide products containing acetic 

acid are liquids and it is therefore, 

unlikely that significant levels of 

repeated inhalation will occur from the 

use of these products. Based on the 

results of toxicity testing cited above, 

proposed herbicide products containing 

acetic acid are placed into Toxicity 

Category IV for acute inhalation toxicity 

and to further mitigate exposure, a REI 

of 48 hours has been added to these 

labels. 

C. Developmental Toxicity 

Developmental toxicity data 

submitted to the Agency demonstrate a 

clear lack of developmental toxicity for 

acetic acid and supports the Agency’s 

conclusion that there is no risk of 

developmental toxicity associated with 

new food uses for acetic acid. 

A prenatal developmental toxicity 

study (MRID 47330503) found no 

significant treatment-related 

reproductive effects. The study showed 

abnormalities of soft or skeletal tissue of 

the test group, but the abnormalities did 

not differ from those found in the 

control group. The study established a 

LOAEL of 1,600 mg/kg bw/day. The 

NOAEL is equal to 1,600 mg/kg bw/day. 

A second prenatal developmental 

toxicity study (MRID 47330503) also, 

found no significant treatment related to 

reproductive effects or fetal 

abnormalities. Based on this 


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information, the Agency believes that 

there is no risk of developmental 

toxicity associated with new food uses 

for acetic acid. 

D. Mutagenicity 

A mutagenicity study using acetic 

acid as the test substance was 

conducted. The reverse mutation assays 

performed (MRID 47330503) were 

negative for mutagenicity to bacteria 

exposed to concentrations of acetic acid 

from 0 micrograms per plate to 10,000 

micrograms per plate with and without 

metabolic activation. In the in-vitro 

Chinese hamster tests (MRID 47330503), 

results were also negative for 

mutagenicity. Results showed that 

acetic acid is not mutagenic at levels 

less than or equal to 16 micromoles. The 

Agency has determined that these data 

are sufficient to confirm that there are 

no expected dietary or non-occupational 

risks of mutagenicity with regard to new 

food uses of acetic acid. 

E. Endocrine Effects 

There is no available evidence 

demonstrating that acetic acid is an 

endocrine disruptor in humans. As a 

result, the Agency is not requiring 

information on the endocrine effects of 

acetic acid at this time. However, the 

Endocrine Disruption Screening 

Program (EDSP) has established a 

protocol, which guides the Agency in 

selecting suspect ingredients for review, 

and the Agency reserves the right to 

require new information should the 

program require it. Presently, based on 

the lack of exposure and the negligible 

toxicity profile of acetic acid, no adverse 

effects to the endocrine system are 

known or expected. Overall, the lack of 

evidence of endocrine disruption is 

consistent with the low toxicity profile 

of acetic acid and supports this 

exemption from the requirement of a 

tolerance. 

IV. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of FFDCA directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). The Agency has determined that 

there is reasonable certainty that no 

harm to the U.S. population will result 

from aggregate exposure to residues of 

acetic acid. This includes all exposures 

for which there is reliable information. 

The Agency arrived at this conclusion 

based on the low level of toxicity of the 

chemical, low anticipated dietary and 

non-dietary exposures, worker 

protection requirements on the label 

(PPE and REI requirements) and the 

already widespread exposure without 

any reported adverse effects on human 

health. The risks from aggregate 

exposure via oral, dermal and inhalation 

exposure are negligible. 

A. Dietary Exposure 

The use of acetic acid as a pesticide 

is not intended as a direct spray to food 

commodities and will not be directly 

applied to food commodities intended 

for human consumption. Therefore, the 

Agency anticipates negligible to no 

residues present at the time of 

consumption. 

1. Food. The Agency expects that food 

commodities will only be exposed to 

acetic acid by accidental application or 

spray drift. The Agency believes that 

any unintentional application or drift of 

products containing acetic acid would 

kill or substantially damage food crops, 

making them undesirable for human 

consumption. However, even in the 

event of indirect spray to food crops, the 

Agency is not concerned with potential 

residues due to low toxicity of acetic 

acid and the fact that acetic acid is a 

weak acid that rapidly degrades into a 

base composed of an acetate ion and 

hydrogen. Finally, the Agency believes 

that because acetic acid biodegrades 

rapidly under both anaerobic and 

aerobic conditions in the environment, 

residues of toxicological concern are not 

expected. 

2. Drinking water exposure. Pesticide 

products containing acetic acid are not 

applied directly to water; applications 

are made directly to terrestrial non food 

crops, and as such, drinking water 

exposure of humans to acetic acid from 

pesticidal use is unlikely. Moreover, the 

Agency believes that any potential 

exposure to surface water would be 

negligible because of the low 

application rates and rapid 

biodegradation of acetic acid. Therefore, 

drinking water exposure is not expected 

to pose any quantifiable risk due to a 

lack of residues of toxicological 

concern. 

B. Other Non-Occupational Exposure— 

Non-Dietary Exposure-Dermal and 

Inhalation Exposure 

The potential for non-dietary 

exposure of the general population, 

including infants and children, is 

limited based on the use patterns of 

acetic acid (see Unit III.A.2., in this unit, 

regarding the use pattern and PPE 

requirements) and REI requirements (48 

hours) on product labels, and the lack 

of anticipated residues of toxicological 

concern. Non-dietary exposures would 

not be expected to pose any quantifiable 

risk to the general population. 

1. Dermal exposure. Nonoccupational dermal exposures to acetic 

acid when used as an indirect nonselective herbicide are expected to be 

negligible based on the use patterns of 

acetic acid (see Unit III.A.2., in this unit, 

regarding the use patterns). 

2. Inhalation exposure. Non 

occupational exposures to acetic acid 

when used as a selective herbicide are 

expected to be negligible because acetic 

acid products are limited to targeted 

weeds and grasses in proximity to food 

crops. 

V. Cumulative Effects from Substances 

with a Common Mechanism of Toxicity 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found acetic acid to share 

a common mechanism of toxicity with 

any other substances, and acetic acid 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that acetic acid does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

The Agency has considered acetic 

acid in light of the relevant safety 

factors in FQPA and FIFRA. A 

determination has been made that no 

unreasonable adverse effects to the U.S. 

population in general, and to infants 

and children in particular, will result 

from the use of acetic acid when label 

instructions are followed. 

A. U.S. Population 

A determination has been made that 

no unreasonable adverse effects to the 

U.S. population in general will result 

from the use of acetic acid when used 

as an indirect spray to control weeds 

and weed grasses when label 

instructions are followed. This 

conclusion is based on the unlikelihood 

of significant dietary residues of acetic 

acid because direct exposure to food 


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plants would be accidental or due to 

spray drift. Additionally, acetic acid 

rapidly biodegrades in the environment; 

it is non-toxic at pesticidal use 

concentrations; it is readily metabolized 

in the body; and, it is ubiquitous in food 

and the environment. Moreover, 

pesticidal uses of acetic acid are not 

expected to contribute significantly to 

the overall exposure of the general 

population, and information from the 

open literature indicates that acetic acid 

has little or no toxicity from an acute 

oral perspective (toxicity category III; 

median LD50 3,310 mg/kg). 

The Agency is reasonably certain that 

there will be no harm to residential and/ 

or commercial workers and applicators 

using herbicide products containing 

acetic acid based on the low application 

rates of end-use products, the low 

toxicity of acetic acid, and the rapid 

biodegradation of acetic acid in the 

environment. Precautionary labeling 

language, personal protective equipment 

and a 48 hour rentry interval for contact 

herbicides containing acetic acid adds 

an additional level of assurance of no 

harm to residential and commercial 

workers using such pesticide products. 

B. Infants and Children 

In examining exposures to sensitive 

subpopulations, FFDCA section 408 

directs EPA to apply an additional 

tenfold margin of exposure (MOE) 

(safety) for infants and children in the 

case of threshold effects to account for 

pre- and post-natal toxicity and the 

completeness of the database, unless 

EPA determines that a different MOE 

will be protective for infants and 

children. MOE are often referred to as 

uncertainty or safety factors. For the 

proposed pesticidal uses, based on all 

the available information, the Agency 

concludes that acetic acid is practically 

non-toxic (with the exception of severe 

eye irritation) to mammals, including 

infants and children. Acetic acid is 

found in many foods already consumed 

by infants and children, and there is no 

information available indicating an 

appreciable difference in risk between 

adults and infants and children from 

exposure to acetic acid when used as a 

contact herbicide. As a result, EPA has 

not used a MOE approach to assess the 

safety of acetic acid. When used as 

proposed, EPA expects that the contact 

herbicides containing acetic acid as an 

active ingredient would not result in 

residue levels that are of toxicological 

concern. Thus, there are no threshold 

effects of concern. As such, an 

additional margin of safety is not 

necessary. 

VII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

internal standards whenever possible, 

consistent with U.S. food safety 

standards and agricultural practices. 

EPA considers the international 

maximum residue limits (MRLs) 

established by the Codex Alimentarius 

Commission (Codes), as required by 

FFDCA section 408(b)(4). The Codex is 

a joint U.N. Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex Level. The Codex has 

not established a MRL for acetic acid. 

VIII. Conclusions 

The Agency concludes that there is a 

reasonable certainty that no harm will 

result to the U.S. population, including 

infants and children, from aggregate 

exposure to residues of acetic acid when 

used as an herbicide to control broadleaf 

weeds and grasses. Therefore, an 

exemption is established for residues of 

the biochemical acetic acid when used 

as a non selective, indirect contact 

herbicide spray for broadleaf weeds and 

weed grasses on all food crops. 

IX. References 

1. MRIDs 47350604 through 

47350609). 

2. MRIDs 47330501, 47330505, 

47330510–47330512 and 47775901). 

3. ‘‘Acetic Acid’’. Codex General 

Standards for Food Additives Online 

Database. 2010. GSFA Online. January 

13, 2010 http:// 

www.codexalimentarius.net/gsfaonline/ 

additives/details.html?id=170. 

4. MRIDs 47350601 through 47350603 

and 47776001. 

5. ‘‘Acetic Acid’’. Hazardous 

Substances Data Base. 2010. National 

Library of Medicine January 13, 2010 

http://www.toxnet.nlm.nih.gov/cgibin/ 

sis/search/f?./temp/~SWRBRt:1. 

6. MRIDs 47330503, 47330504, 

47330507, 47330508 and 47330513- 

47330518). 

7. Joint FAO/WHO Expert Committee 

on Food Additives. ‘‘Toxicological 

Evaluation of Some Microbials, 

Antioxidants, Emulsifiers, Stabilizers, 

Flour-Treatment Agents, Acids and 

Bases.’’ 1967. WHO/Food Add. January 

13, 2010 http://www.inchem.org/ 

documents/jecfa/jecmono/ 

40abcj37.htm. 

8. EPA Memorandum R.S. Jones to D. 

Benmhend. ‘‘Science Review in Support 

of the Registration of Eastman Acetic 

Acid® P Grain and Hay Preservative. . 

. .’’. April 12, 2004. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Rules and Regulations 40741 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

XI. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 30, 2010. 

W. Michael McDavit, 

Acting Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In subpart D, revise §180.1258 to 

read as follows: 

§ 180.1258 Acetic acid; exemption from 

the requirement of a tolerance. 

(a) An exemption from the 

requirement of a tolerance is established 

for residues of the biochemical pesticide 

acetic acid when used as a preservative 

on post-harvest agricultural 

commodities intended for animal feed, 

including Alfalfa, seed; alfalfa, hay; 

barley, grain; bermudagrass, hay; 

bluegrass, hay; bromegrass, hay; clover, 

hay; corn, field, grain; corn, pop, grain; 

cowpea, hay; fescue, hay; lespedeza, 

hay; lupin; oat, grain; orchardgrass, hay; 

peanut, hay; timothy, hay; vetch, hay; 

and wheat, grain, or commodities 

described as grain or hay. 

(b) An exemption from the 

requirement of a tolerance is established 

for residues of acetic acid in or on all 

food crops resulting from unintentional 

spray and drift to non-target vegetation 

including non-food, food and feed crops 

when used as a non-selective contact 

herbicide spray. 

[FR Doc. 2010–17163 Filed 7–13–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0325; FRL–8833–6] 

Hexythiazox; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation revises 

tolerances for combined residues of 

hexythiazox in or on stone fruit. Gowan 

Company requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective July 

14, 2010. Objections and requests for 

hearings must be received on or before 

September 13, 2010, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0325. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: Olga 

Odiott, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9369; e-mail address: 

odiott.olga@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.gpoaccess.gov/ecfr. 

C. How Can I File an Objection or 

Hearing Request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1