
[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Rules and Regulations]
[Pages 48749-48752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20001]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0793; FRL-9930-20]


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 exemption from the requirement of a 
tolerance for residues of acetic acid (CAS Reg. No. 64-19-7) when used 
as an inert ingredient in antimicrobial pesticide formulations used on 
dairy and food-processing equipment and utensils, to allow for a 
limitation of 1200 ppm. Technology Sciences Group, Inc. on behalf of 
West Agro, Inc. submitted a petition to EPA under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), requesting an amendment to the existing 
exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of acetic acid.

DATES: This regulation is effective August 14, 2015. Objections and 
requests for hearings must be received on or before October 13, 2015, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2014-0793, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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 provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2014-0793 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 
October 13, 2015. 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 (excluding

[[Page 48750]]

any Confidential Business Information (CBI)) for inclusion in the 
public docket. Information not marked confidential pursuant to 40 CFR 
part 2 may be disclosed publicly by EPA without prior notice. Submit 
the non-CBI copy of your objection or hearing request, identified by 
docket ID number EPA-HQ-OPP-2014-0793, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of March 4, 2015 (80 FR 11611) (FRL-9922-
68), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition inert ingredient 
(IN-10766) by Technology Sciences Group, Inc. (1150 18th Street, Suite 
1000 Washington, DC 20036), on behalf of West Agro, Inc. (11100 
Congress Ave., Kansas City, MO 64153). The petition requested that 40 
CFR 180.940(b) and (c) be amended by modifying an exemption from the 
requirement of a tolerance for residues of acetic acid (CAS Reg No. 64-
19-7) when used as an inert ingredient to promote the active ingredient 
in antimicrobial pesticide formulations applied to dairy-processing 
equipment, food-processing equipment, and utensils to increase the use 
limitation from 686 parts per million (ppm) to 1,200 ppm. That document 
referenced a summary of the petition prepared by Technology Sciences 
Group, Inc. on behalf of West Agro, Inc., the petitioner, which is 
available in the docket, http://www.regulations.gov. No comments were 
received on the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    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 tolerance is ``safe.'' Section 408(b)(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. Section 408(b)(2)(C) of FFDCA requires 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. . . .''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for acetic acid including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with acetic acid follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies 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. Specific information on the studies received and the nature 
of the adverse effects caused by acetic acid as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this 
unit.
    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. Although, reduced body weight 
was observed at 390 milligrams/kilograms/day (mg/kg/day) in a 90-day 
oral toxicity study in the rat, the reduction in weight gain was likely 
attributed to reduced appetite and food consumption observed in the 
study. Therefore, this is not considered an adverse effect. Fetal 
susceptibility was not observed in developmental studies in rats, mice 
and rabbits. It is not genotoxic, mutagenic, carcinogenic or 
neurotoxic. Although, increased spleen weight and increased levels of 
iron stored in the spleen were observed in a toxicity study via 
inhalation in rats, these effects are not considered an immunotoxic 
response, but are due to the destruction of red blood cells; therefore, 
there is no concern for potential immunotoxicity.
    Acetic acid undergoes 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. 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

[[Page 48751]]

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.
    Specific information on the studies received and the nature of the 
adverse effects caused by acetic acid as well as the no observed 
adverse effect level (NOAEL) and the lowest observed adverse effect 
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document ``Acetic Acid; Human Health Risk 
Assessment and Ecological Effects Assessment to Support Proposed 
Exemption from the Requirement of a Tolerance When Used as Inert 
Ingredients in Pesticide Formulations'' in docket ID number EPA-HQ-OPP-
2014-0793.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    Based on the widespread presence of acetic acid in human foods, and 
the fact that acetic acid is a normal metabolite in humans and animals 
and its status as a substance that is considered Generally Recognized 
as Safe (GRAS) by the Food and Drug Administration, toxicological 
endpoints of concern relevant to human exposures have not been 
identified for acetic acid. Thus, due to its low potential hazard and 
lack of hazard endpoint, the Agency has determined that a quantitative 
risk assessment using safety factors applied to a point of departure 
protective of an identified hazard endpoint is not appropriate. 
Instead, the Agency's assessment of the risk from acetic acid is 
qualitative.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses and drinking water. In 
evaluating dietary exposure to acetic acid, EPA considered exposure 
under the proposed exemption from the requirement of a tolerance. EPA 
assessed dietary exposures from acetic acid in food as follows:
    Acetic acid is currently used as a biochemical pesticide post-
harvest on grains, hays for animal feed, and as a herbicide. Under this 
exemption from the requirement of a tolerance, residues of this 
chemical also may be found on foods that come in contact with treated 
dairy and food-processing equipment and utensils. However, a 
quantitative dietary exposure assessment was not conducted since an 
endpoint for risk assessment was not identified.
    2. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    Acetic acid may be used in pesticide products and nonpesticide 
products that may be used around the home. Since an endpoint for risk 
assessment was not identified, a quantitative residential exposure 
assessment for acetic acid was not conducted.
    3. 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 Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    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 an 
assessment of acetic acid and its chemical properties, EPA has 
concluded that there are no toxicological endpoints of concern for the 
U.S. population, including infants and children.

E. Aggregate Risks and Determination of Safety

    Because no toxicological endpoints of concern were identified, EPA 
concludes that aggregate exposure to residues of acetic acid will not 
pose a risk to the U.S. population, including infants and children, and 
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 residues.

V. 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. EPA is establishing a limitation on the amount of acetic 
acid that may be used in pesticide formulations.
    The limitation will be enforced through the pesticide registration 
process under the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA), 7 U.S.C. 136 et seq. EPA will not register any antimicrobial 
pesticide formulation used on dairy processing equipment or food-
processing

[[Page 48752]]

equipment and utensils for sale or distribution containing acetic acid 
at ready for use end-use concentrations exceeding 1,200 parts per 
million.

VI. Conclusions

    Therefore, the exemption from the requirement of a tolerance for 
acetic acid when used as an inert ingredient in antimicrobial pesticide 
formulations used on dairy-processing equipment, food-processing 
equipment, and utensils under 40 CFR 180.940(b) and (c) are amended by 
an increase in the use limitation from 686 ppm to 1,200 ppm.

VII. Statutory and Executive Order Reviews

    This action amends exemptions from the requirement of a tolerance 
under FFDCA section 408(d) 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 action has been exempted from review under Executive Order 
12866, this action 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 
action 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 FFDCA section 408(d), such as the exemption 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 action 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 FFDCA section 408(n)(4). 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 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: July 30, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    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 Sec.  180.940(b) and (c), revise the entry for ``Acetic acid'' to 
read as follows:


Sec.  180.940  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food-contact surface sanitizing 
solutions).

* * * * *
    (b) * * *

------------------------------------------------------------------------
       Pesticide chemical          CAS Reg. No.           Limits
------------------------------------------------------------------------
Acetic acid....................         64-19-7   When ready for use,
                                                   the end-use
                                                   concentration is not
                                                   to exceed 1200 ppm.
 
                              * * * * * * *
------------------------------------------------------------------------

    (c) * * *

------------------------------------------------------------------------
       Pesticide chemical          CAS Reg. No.           Limits
------------------------------------------------------------------------
Acetic acid....................         64-19-7   When ready for use,
                                                   the end-use
                                                   concentration is not
                                                   to exceed 1,200 ppm.
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2015-20001 Filed 8-13-15; 8:45 am]
BILLING CODE 6560-50-P


