80_FR_48906 80 FR 48749 - Acetic Acid; Exemption From the Requirement of a Tolerance

80 FR 48749 - Acetic Acid; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 157 (August 14, 2015)

Page Range48749-48752
FR Document2015-20001

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.

Federal Register, Volume 80 Issue 157 (Friday, August 14, 2015)
[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Rules and Regulations]
[Pages 48749-48752]
From the Federal Register Online  [www.thefederalregister.org]
[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: [email protected].

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



                                                               Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Rules and Regulations                                          48749

                                            Agency consideration of voluntary                                                                 Parts per    information about the docket available
                                                                                                               Commodity
                                            consensus standards pursuant to section                                                            million     at http://www.epa.gov/dockets.
                                            12(d) of the National Technology                                                                               FOR FURTHER INFORMATION CONTACT:
                                            Transfer and Advancement Act                                                                                   Susan Lewis, Registration Division
                                            (NTTAA) (15 U.S.C. 272 note).                           *          *           *          *           *
                                                                                                                                                           (7505P), Office of Pesticide Programs,
                                            VII. Congressional Review Act                                                                                  Environmental Protection Agency, 1200
                                                                                                    *      *       *      *       *                        Pennsylvania Ave. NW., Washington,
                                              Pursuant to the Congressional Review                                                                         DC 20460–0001; main telephone
                                                                                                    [FR Doc. 2015–20019 Filed 8–13–15; 8:45 am]
                                            Act (5 U.S.C. 801 et seq.), EPA will                                                                           number: (703) 305–7090; email address:
                                                                                                    BILLING CODE 6560–50–P
                                            submit a report containing this rule and                                                                       RDFRNotices@epa.gov.
                                            other required information to the U.S.                                                                         SUPPLEMENTARY INFORMATION:
                                            Senate, the U.S. House of                               ENVIRONMENTAL PROTECTION
                                            Representatives, and the Comptroller                                                                           I. General Information
                                                                                                    AGENCY
                                            General of the United States prior to                                                                          A. Does this action apply to me?
                                            publication of the rule in the Federal                  40 CFR Part 180
                                            Register. This action is not a ‘‘major                                                                            You may be potentially affected by
                                            rule’’ as defined by 5 U.S.C. 804(2).                   [EPA–HQ–OPP–2014–0793; FRL–9930–20]                    this action if you are an agricultural
                                                                                                                                                           producer, food manufacturer, or
                                            List of Subjects in 40 CFR Part 180                     Acetic Acid; Exemption From the                        pesticide manufacturer. The following
                                              Environmental protection,                             Requirement of a Tolerance                             list of North American Industrial
                                            Administrative practice and procedure,                  AGENCY:  Environmental Protection                      Classification System (NAICS) codes is
                                            Agricultural commodities, Pesticides                    Agency (EPA).                                          not intended to be exhaustive, but rather
                                            and pests, Reporting and recordkeeping                  ACTION: Final rule.
                                                                                                                                                           provides a guide to help readers
                                            requirements.                                                                                                  determine whether this document
                                              Dated: August 6, 2015.                                SUMMARY:     This regulation amends the                applies to them. Potentially affected
                                                                                                      exemption from the requirement of a                  entities may include:
                                            Susan Lewis,
                                                                                                      tolerance for residues of acetic acid                   • Crop production (NAICS code 111).
                                            Director, Registration Division, Office of                                                                        • Animal production (NAICS code
                                            Pesticide Programs.                                       (CAS Reg. No. 64–19–7) when used as
                                                                                                      an inert ingredient in antimicrobial                 112).
                                               Therefore, 40 CFR chapter I is                                                                                 • Food manufacturing (NAICS code
                                            amended as follows:                                       pesticide formulations used on dairy
                                                                                                      and food-processing equipment and                    311).
                                                                                                      utensils, to allow for a limitation of                  • Pesticide manufacturing (NAICS
                                            PART 180—[AMENDED]
                                                                                                      1200 ppm. Technology Sciences Group,                 code 32532).
                                            ■ 1. The authority citation for part 180                  Inc. on behalf of West Agro, Inc.                    B. How can I get electronic access to
                                            continues to read as follows:                             submitted a petition to EPA under the                other related information?
                                               Authority: 21 U.S.C. 321(q), 346a and 371.             Federal Food, Drug, and Cosmetic Act
                                                                                                      (FFDCA), requesting an amendment to                    You may access a frequently updated
                                            ■ 2. In § 180.516:                                                                                             electronic version of 40 CFR part 180
                                                                                                      the existing exemption from the
                                            ■ a. Remove the entry in the table in                                                                          through the Government Printing
                                                                                                      requirement of a tolerance. This
                                            paragraph (a) for ‘‘Rapeseed, seed’’.                                                                          Office’s e-CFR site at http://
                                                                                                      regulation eliminates the need to
                                            ■ b. Add alphabetically the entries for                                                                        www.ecfr.gov/cgi-bin/text-
                                                                                                      establish a maximum permissible level
                                            ‘‘Carrots’’ and ‘‘Rapeseed subgroup 20A,                                                                       idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                                                                                      for residues of acetic acid.
                                            except flax seed’’ to the table in                                                                             40tab_02.tpl.
                                            paragraph (a).                                            DATES  : This regulation is effective
                                            ■ c. Revise the entry for ‘‘Fruit, stone,                 August 14, 2015. Objections and                      C. How can I file an objection or hearing
                                            group 12’’ to read ‘‘Fruit, stone, group                  requests for hearings must be received               request?
                                            12–12’’ in the table in paragraph (a).                    on or before October 13, 2015, and must                Under FFDCA section 408(g), 21
                                               The additions and revisions read as                    be filed in accordance with the                      U.S.C. 346a, any person may file an
                                            follows:                                                  instructions provided in 40 CFR part                 objection to any aspect of this regulation
                                                                                                      178 (see also Unit I.C. of the                       and may also request a hearing on those
                                            § 180.516 Fludioxonil; tolerances for                     SUPPLEMENTARY INFORMATION).                          objections. You must file your objection
                                            residues.
                                                                                                      ADDRESSES: The docket for this action,               or request a hearing on this regulation
                                               (a) * * *                                              identified by docket identification (ID)             in accordance with the instructions
                                               (1) * * *                                              number EPA–HQ–OPP–2014–0793, is                      provided in 40 CFR part 178. To ensure
                                                                                                      available at http://www.regulations.gov              proper receipt by EPA, you must
                                                                                        Parts per     or at the Office of Pesticide Programs
                                                       Commodity                         million                                                           identify docket ID number EPA–HQ–
                                                                                                      Regulatory Public Docket (OPP Docket)                OPP–2014–0793 in the subject line on
                                                                                                      in the Environmental Protection Agency               the first page of your submission. All
                                            *          *              *               *     *         Docket Center (EPA/DC), West William                 objections and requests for a hearing
                                                                                                      Jefferson Clinton Bldg., Rm. 3334, 1301              must be in writing, and must be
                                            Carrots ..................................            7.0 Constitution Ave. NW., Washington, DC                received by the Hearing Clerk on or
                                                                                                      20460–0001. The Public Reading Room                  before October 13, 2015. Addresses for
                                            *          *              *               *     *         is open from 8:30 a.m. to 4:30 p.m.,                 mail and hand delivery of objections
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                                                                                                      Monday through Friday, excluding legal               and hearing requests are provided in 40
                                            Fruit, stone, group 12–12 .....                       5.0
                                                                                                      holidays. The telephone number for the               CFR 178.25(b).
                                            *          *              *               *     *         Public Reading Room is (202) 566–1744,                 In addition to filing an objection or
                                                                                                      and the telephone number for the OPP                 hearing request with the Hearing Clerk
                                            Rapeseed subgroup 20A, ex-                                Docket is (703) 305–5805. Please review              as described in 40 CFR part 178, please
                                               cept flax seed ....................               0.01 the visitor instructions and additional              submit a copy of the filing (excluding


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                                            48750              Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Rules and Regulations

                                            any Confidential Business Information                   pesticidal efficacy of their own):                    requirement of a tolerance may be
                                            (CBI)) for inclusion in the public docket.              Solvents such as alcohols and                         established.
                                            Information not marked confidential                     hydrocarbons; surfactants such as                       Consistent with FFDCA section
                                            pursuant to 40 CFR part 2 may be                        polyoxyethylene polymers and fatty                    408(c)(2)(A), and the factors specified in
                                            disclosed publicly by EPA without prior                 acids; carriers such as clay and                      FFDCA section 408(c)(2)(B), EPA has
                                            notice. Submit the non-CBI copy of your                 diatomaceous earth; thickeners such as                reviewed the available scientific data
                                            objection or hearing request, identified                carrageenan and modified cellulose;                   and other relevant information in
                                            by docket ID number EPA–HQ–OPP–                         wetting, spreading, and dispersing                    support of this action. EPA has
                                            2014–0793, by one of the following                      agents; propellants in aerosol                        sufficient data to assess the hazards of
                                            methods:                                                dispensers; microencapsulating agents;                and to make a determination on
                                              • Federal eRulemaking Portal: http://                 and emulsifiers. The term ‘‘inert’’ is not            aggregate exposure for acetic acid
                                            www.regulations.gov. Follow the online                  intended to imply nontoxicity; the                    including exposure resulting from the
                                            instructions for submitting comments.                   ingredient may or may not be                          exemption established by this action.
                                            Do not submit electronically any                        chemically active. Generally, EPA has                 EPA’s assessment of exposures and risks
                                            information you consider to be CBI or                   exempted inert ingredients from the                   associated with acetic acid follows.
                                            other information whose disclosure is                   requirement of a tolerance based on the               A. Toxicological Profile
                                            restricted by statute.                                  low toxicity of the individual inert
                                              • Mail: OPP Docket, Environmental                     ingredients.                                             EPA has evaluated the available
                                            Protection Agency Docket Center (EPA/                                                                         toxicity data and considered their
                                                                                                    IV. Aggregate Risk Assessment and                     validity, completeness, and reliability as
                                            DC), (28221T), 1200 Pennsylvania Ave.
                                                                                                    Determination of Safety                               well as the relationship of the results of
                                            NW., Washington, DC 20460–0001.
                                              • Hand Delivery: To make special                         Section 408(c)(2)(A)(i) of FFDCA                   the studies to human risk. EPA has also
                                            arrangements for hand delivery or                       allows EPA to establish an exemption                  considered available information
                                            delivery of boxed information, please                   from the requirement for a tolerance (the             concerning the variability of the
                                            follow the instructions at http://                      legal limit for a pesticide chemical                  sensitivities of major identifiable
                                            www.epa.gov/dockets/contacts.html.                      residue in or on a food) only if EPA                  subgroups of consumers, including
                                              Additional instructions on                            determines that the tolerance is ‘‘safe.’’            infants and children. Specific
                                            commenting or visiting the docket,                      Section 408(b)(2)(A)(ii) of FFDCA                     information on the studies received and
                                            along with more information about                       defines ‘‘safe’’ to mean that ‘‘there is a            the nature of the adverse effects caused
                                            dockets generally, is available at                      reasonable certainty that no harm will                by acetic acid as well as the no-
                                            http://www.epa.gov/dockets.                             result from aggregate exposure to the                 observed-adverse-effect-level (NOAEL)
                                                                                                    pesticide chemical residue, including                 and the lowest-observed-adverse-effect-
                                            II. Petition for Exemption                              all anticipated dietary exposures and all             level (LOAEL) from the toxicity studies
                                               In the Federal Register of March 4,                  other exposures for which there is                    are discussed in this unit.
                                            2015 (80 FR 11611) (FRL–9922–68),                       reliable information.’’ This includes                    Acetic acid is of low acute dermal and
                                            EPA issued a document pursuant to                       exposure through drinking water and in                inhalation toxicity in rats. It causes
                                            FFDCA section 408, 21 U.S.C. 346a,                      residential settings, but does not include            dermal irritation in mice and is
                                            announcing the filing of a pesticide                    occupational exposure. Section                        corrosive in rabbits. It was also irritating
                                            petition inert ingredient (IN–10766) by                 408(b)(2)(C) of FFDCA requires EPA to                 in the eyes of rabbits. Although, reduced
                                            Technology Sciences Group, Inc. (1150                   give special consideration to exposure                body weight was observed at 390
                                            18th Street, Suite 1000 Washington, DC                  of infants and children to the pesticide              milligrams/kilograms/day (mg/kg/day)
                                            20036), on behalf of West Agro, Inc.                    chemical residue in establishing a                    in a 90-day oral toxicity study in the rat,
                                            (11100 Congress Ave., Kansas City, MO                   tolerance and to ‘‘ensure that there is a             the reduction in weight gain was likely
                                            64153). The petition requested that 40                  reasonable certainty that no harm will                attributed to reduced appetite and food
                                            CFR 180.940(b) and (c) be amended by                    result to infants and children from                   consumption observed in the study.
                                            modifying an exemption from the                         aggregate exposure to the pesticide                   Therefore, this is not considered an
                                            requirement of a tolerance for residues                 chemical residue. . . .’’                             adverse effect. Fetal susceptibility was
                                            of acetic acid (CAS Reg No. 64–19–7)                       EPA establishes exemptions from the                not observed in developmental studies
                                            when used as an inert ingredient to                     requirement of a tolerance only in those              in rats, mice and rabbits. It is not
                                            promote the active ingredient in                        cases where it can be clearly                         genotoxic, mutagenic, carcinogenic or
                                            antimicrobial pesticide formulations                    demonstrated that the risks from                      neurotoxic. Although, increased spleen
                                            applied to dairy-processing equipment,                  aggregate exposure to pesticide                       weight and increased levels of iron
                                            food-processing equipment, and utensils                 chemical residues under reasonably                    stored in the spleen were observed in a
                                            to increase the use limitation from 686                 foreseeable circumstances will pose no                toxicity study via inhalation in rats,
                                            parts per million (ppm) to 1,200 ppm.                   appreciable risks to human health. In                 these effects are not considered an
                                            That document referenced a summary of                   order to determine the risks from                     immunotoxic response, but are due to
                                            the petition prepared by Technology                     aggregate exposure to pesticide inert                 the destruction of red blood cells;
                                            Sciences Group, Inc. on behalf of West                  ingredients, the Agency considers the                 therefore, there is no concern for
                                            Agro, Inc., the petitioner, which is                    toxicity of the inert in conjunction with             potential immunotoxicity.
                                            available in the docket, http://                        possible exposure to residues of the                     Acetic acid undergoes dissociation to
                                            www.regulations.gov. No comments                        inert ingredient through food, drinking               the acetate anion and the H+ cations in
                                            were received on the notice of filing.                  water, and through other exposures that               aqueous media at pHs commonly found
                                                                                                    occur as a result of pesticide use in                 in the environment. Also, it is a
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                                            III. Inert Ingredient Definition                        residential settings. If EPA is able to               naturally-occurring substance in plants
                                               Inert ingredients are all ingredients                determine that a finite tolerance is not              and animals. In aerobic metabolism,
                                            that are not active ingredients as defined              necessary to ensure that there is a                   acetic acid (as acetate) is a metabolite
                                            in 40 CFR 153.125 and include, but are                  reasonable certainty that no harm will                that combines with Co-enzyme A to
                                            not limited to, the following types of                  result from aggregate exposure to the                 form acetyl Co-A which subsequently
                                            ingredients (except when they have a                    inert ingredient, an exemption from the               enters into the Citric Acid Cycle, a


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                                                               Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Rules and Regulations                                         48751

                                            common metabolic pathway in which                       acetic acid. Thus, due to its low                     mechanism of toxicity and to evaluate
                                            food molecules are broken down to form                  potential hazard and lack of hazard                   the cumulative effects of such
                                            energy. A major function of the Citric                  endpoint, the Agency has determined                   chemicals, see EPA’s Web site at
                                            Acid Cycle is the oxidation of acetate.                 that a quantitative risk assessment using             http://www.epa.gov/pesticides/
                                            In animals, acetate is obtained from the                safety factors applied to a point of                  cumulative.
                                            breakdown of glucose molecules.                         departure protective of an identified
                                               Specific information on the studies                  hazard endpoint is not appropriate.                   D. Safety Factor for Infants and
                                            received and the nature of the adverse                  Instead, the Agency’s assessment of the               Children
                                            effects caused by acetic acid as well as                risk from acetic acid is qualitative.                   1. In general. Section 408(b)(2)(C) of
                                            the no observed adverse effect level                                                                          FFDCA provides that EPA shall apply
                                            (NOAEL) and the lowest observed                         C. Exposure Assessment
                                                                                                                                                          an additional tenfold (10X) margin of
                                            adverse effect level (LOAEL) from the                      1. Dietary exposure from food and                  safety for infants and children in the
                                            toxicity studies can be found at http://                feed uses and drinking water. In                      case of threshold effects to account for
                                            www.regulations.gov in the document                     evaluating dietary exposure to acetic                 prenatal and postnatal toxicity and the
                                            ‘‘Acetic Acid; Human Health Risk                        acid, EPA considered exposure under                   completeness of the database on toxicity
                                            Assessment and Ecological Effects                       the proposed exemption from the                       and exposure unless EPA determines
                                            Assessment to Support Proposed                          requirement of a tolerance. EPA                       based on reliable data that a different
                                            Exemption from the Requirement of a                     assessed dietary exposures from acetic                margin of safety will be safe for infants
                                            Tolerance When Used as Inert                            acid in food as follows:                              and children. This additional margin of
                                            Ingredients in Pesticide Formulations’’                    Acetic acid is currently used as a                 safety is commonly referred to as the
                                            in docket ID number EPA–HQ–OPP–                         biochemical pesticide post-harvest on                 Food Quality Protection Act Safety
                                            2014–0793.                                              grains, hays for animal feed, and as a                Factor (FQPA SF). In applying this
                                                                                                    herbicide. Under this exemption from                  provision, EPA either retains the default
                                            B. Toxicological Points of Departure/                   the requirement of a tolerance, residues
                                            Levels of Concern                                                                                             value of 10X, or uses a different
                                                                                                    of this chemical also may be found on                 additional safety factor when reliable
                                               Once a pesticide’s toxicological                     foods that come in contact with treated               data available to EPA support the choice
                                            profile is determined, EPA identifies                   dairy and food-processing equipment                   of a different factor.
                                            toxicological points of departure (POD)                 and utensils. However, a quantitative                   As part of its qualitative assessment,
                                            and levels of concern to use in                         dietary exposure assessment was not                   the Agency did not use safety factors for
                                            evaluating the risk posed by human                      conducted since an endpoint for risk                  assessing risk, and no additional safety
                                            exposure to the pesticide. For hazards                  assessment was not identified.                        factor is needed for assessing risk to
                                            that have a threshold below which there                    2. From non-dietary exposure. The
                                                                                                                                                          infants and children. Based on an
                                            is no appreciable risk, the toxicological               term ‘‘residential exposure’’ is used in
                                                                                                                                                          assessment of acetic acid and its
                                            POD is used as the basis for derivation                 this document to refer to non-
                                                                                                                                                          chemical properties, EPA has concluded
                                            of reference values for risk assessment.                occupational, non-dietary exposure
                                                                                                                                                          that there are no toxicological endpoints
                                            PODs are developed based on a careful                   (e.g., textiles (clothing and diapers),
                                                                                                                                                          of concern for the U.S. population,
                                            analysis of the doses in each                           carpets, swimming pools, and hard
                                                                                                                                                          including infants and children.
                                            toxicological study to determine the                    surface disinfection on walls, floors,
                                            dose at which no adverse effects are                    tables).                                              E. Aggregate Risks and Determination of
                                            observed (the NOAEL) and the lowest                        Acetic acid may be used in pesticide               Safety
                                            dose at which adverse effects of concern                products and nonpesticide products that                 Because no toxicological endpoints of
                                            are identified (the LOAEL). Uncertainty/                may be used around the home. Since an                 concern were identified, EPA concludes
                                            safety factors are used in conjunction                  endpoint for risk assessment was not                  that aggregate exposure to residues of
                                            with the POD to calculate a safe                        identified, a quantitative residential                acetic acid will not pose a risk to the
                                            exposure level—generally referred to as                 exposure assessment for acetic acid was               U.S. population, including infants and
                                            a population-adjusted dose (PAD) or a                   not conducted.                                        children, and that there is a reasonable
                                            reference dose (RfD)—and a safe margin                     3. Cumulative effects from substances
                                                                                                                                                          certainty that no harm will result to the
                                            of exposure (MOE). For non-threshold                    with a common mechanism of toxicity.
                                                                                                                                                          general population, or to infants and
                                            risks, the Agency assumes that any                      Section 408(b)(2)(D)(v) of FFDCA
                                                                                                                                                          children from aggregate exposure to
                                            amount of exposure will lead to some                    requires that, when considering whether
                                                                                                                                                          acetic acid residues.
                                            degree of risk. Thus, the Agency                        to establish, modify, or revoke a
                                            estimates risk in terms of the probability              tolerance, the Agency consider                        V. Other Considerations
                                            of an occurrence of the adverse effect                  ‘‘available information’’ concerning the
                                                                                                                                                          A. Analytical Enforcement Methodology
                                            expected in a lifetime. For more                        cumulative effects of a particular
                                            information on the general principles                   pesticide’s residues and ‘‘other                         An analytical method is not required
                                            EPA uses in risk characterization and a                 substances that have a common                         for enforcement purposes since the
                                            complete description of the risk                        mechanism of toxicity.’’                              Agency is establishing an exemption
                                            assessment process, see http://                            EPA has not found acetic acid to share             from the requirement of a tolerance.
                                            www.epa.gov/pesticides/factsheets/                      a common mechanism of toxicity with                   EPA is establishing a limitation on the
                                            riskassess.htm.                                         any other substances, and acetic acid                 amount of acetic acid that may be used
                                               Based on the widespread presence of                  does not appear to produce a toxic                    in pesticide formulations.
                                            acetic acid in human foods, and the fact                metabolite produced by other                             The limitation will be enforced
                                            that acetic acid is a normal metabolite                 substances. For the purposes of this                  through the pesticide registration
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                                            in humans and animals and its status as                 tolerance action, therefore, EPA has                  process under the Federal Insecticide,
                                            a substance that is considered Generally                assumed that acetic acid does not have                Fungicide, and Rodenticide Act
                                            Recognized as Safe (GRAS) by the Food                   a common mechanism of toxicity with                   (FIFRA), 7 U.S.C. 136 et seq. EPA will
                                            and Drug Administration, toxicological                  other substances. For information                     not register any antimicrobial pesticide
                                            endpoints of concern relevant to human                  regarding EPA’s efforts to determine                  formulation used on dairy processing
                                            exposures have not been identified for                  which chemicals have a common                         equipment or food-processing


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                                            48752                    Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Rules and Regulations

                                            equipment and utensils for sale or                                   Environmental Justice in Minority                     12(d) of the National Technology
                                            distribution containing acetic acid at                               Populations and Low-Income                            Transfer and Advancement Act
                                            ready for use end-use concentrations                                 Populations’’ (59 FR 7629, February 16,               (NTTAA) (15 U.S.C. 272 note).
                                            exceeding 1,200 parts per million.                                   1994).
                                                                                                                    Since tolerances and exemptions that               VIII. Congressional Review Act
                                            VI. Conclusions                                                      are established on the basis of a petition              Pursuant to the Congressional Review
                                              Therefore, the exemption from the                                  under FFDCA section 408(d), such as                   Act (5 U.S.C. 801 et seq.), EPA will
                                            requirement of a tolerance for acetic                                the exemption in this final rule, do not              submit a report containing this rule and
                                            acid when used as an inert ingredient in                             require the issuance of a proposed rule,              other required information to the U.S.
                                            antimicrobial pesticide formulations                                 the requirements of the Regulatory                    Senate, the U.S. House of
                                            used on dairy-processing equipment,                                  Flexibility Act (RFA) (5 U.S.C. 601 et                Representatives, and the Comptroller
                                            food-processing equipment, and utensils                              seq.), do not apply.                                  General of the United States prior to
                                            under 40 CFR 180.940(b) and (c) are                                     This action directly regulates growers,            publication of the rule in the Federal
                                            amended by an increase in the use                                    food processors, food handlers, and food              Register. This action is not a ‘‘major
                                            limitation from 686 ppm to 1,200 ppm.                                retailers, not States or tribes, nor does             rule’’ as defined by 5 U.S.C. 804(2).
                                                                                                                 this action alter the relationships or
                                            VII. Statutory and Executive Order                                                                                         List of Subjects in 40 CFR Part 180
                                                                                                                 distribution of power and
                                            Reviews
                                                                                                                 responsibilities established by Congress                Environmental protection,
                                               This action amends exemptions from                                in the preemption provisions of FFDCA
                                            the requirement of a tolerance under                                                                                       Administrative practice and procedure,
                                                                                                                 section 408(n)(4). As such, the Agency                Agricultural commodities, Pesticides
                                            FFDCA section 408(d) in response to a                                has determined that this action will not
                                            petition submitted to the Agency. The                                                                                      and pests, Reporting and recordkeeping
                                                                                                                 have a substantial direct effect on States
                                            Office of Management and Budget                                                                                            requirements.
                                                                                                                 or tribal governments, on the
                                            (OMB) has exempted these types of                                    relationship between the national                       Dated: July 30, 2015.
                                            actions from review under Executive                                  government and the States or tribal                   Susan Lewis,
                                            Order 12866, entitled ‘‘Regulatory                                   governments, or on the distribution of                Director, Registration Division, Office of
                                            Planning and Review’’ (58 FR 51735,                                  power and responsibilities among the                  Pesticide Programs.
                                            October 4, 1993). Because this action                                various levels of government or between                 Therefore, 40 CFR chapter I is
                                            has been exempted from review under                                  the Federal Government and Indian                     amended as follows:
                                            Executive Order 12866, this action is                                tribes. Thus, the Agency has determined
                                            not subject to Executive Order 13211,                                that Executive Order 13132, entitled                  PART 180—[AMENDED]
                                            entitled ‘‘Actions Concerning                                        ‘‘Federalism’’ (64 FR 43255, August 10,
                                            Regulations That Significantly Affect                                1999) and Executive Order 13175,                      ■ 1. The authority citation for part 180
                                            Energy Supply, Distribution, or Use’’ (66                            entitled ‘‘Consultation and Coordination              continues to read as follows:
                                            FR 28355, May 22, 2001) or Executive                                 with Indian Tribal Governments’’ (65 FR
                                                                                                                                                                           Authority: 21 U.S.C. 321(q), 346a and 371.
                                            Order 13045, entitled ‘‘Protection of                                67249, November 9, 2000) do not apply
                                            Children from Environmental Health                                   to this action. In addition, this action              ■ 2. In § 180.940(b) and (c), revise the
                                            Risks and Safety Risks’’ (62 FR 19885,                               does not impose any enforceable duty or               entry for ‘‘Acetic acid’’ to read as
                                            April 23, 1997). This action does not                                contain any unfunded mandate as                       follows:
                                            contain any information collections                                  described under Title II of the Unfunded
                                            subject to OMB approval under the                                    Mandates Reform Act (UMRA) (2 U.S.C.                  § 180.940 Tolerance exemptions for active
                                            Paperwork Reduction Act (PRA) (44                                    1501 et seq.).                                        and inert ingredients for use in
                                            U.S.C. 3501 et seq.), nor does it require                               This action does not involve any                   antimicrobial formulations (Food-contact
                                            any special considerations under                                     technical standards that would require                surface sanitizing solutions).
                                            Executive Order 12898, entitled                                      Agency consideration of voluntary                     *       *    *        *   *
                                            ‘‘Federal Actions to Address                                         consensus standards pursuant to section                   (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.

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




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Document Created: 2018-02-23 10:59:07
Document Modified: 2018-02-23 10:59:07
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactSusan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation80 FR 48749 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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