Acetic Acid; Exemption from the Requirement of a Tolerance, 40736-40741 [2010-17163]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 75, Number 134 (Wednesday, July 14, 2010)]
[Rules and Regulations]
[Pages 40736-40741]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17163]


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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.

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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 non-food, 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 https://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 https://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 https://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: https://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, https://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.

[[Page 40737]]

    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 post-harvest 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

[[Page 40738]]

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

[[Page 40739]]

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 non-occupational 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. Non-occupational dermal exposures to acetic 
acid when used as an indirect non-selective 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 https://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

[[Page 40740]]

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  https://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 https://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 https://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[reg] 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

[[Page 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.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. In subpart D, revise Sec. 180.1258 to read as follows:


Sec.  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