80 FR 61118 - Trans-1,3,3,3-tetrafluoroprop-1-ene; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 196 (October 9, 2015)

Page Range		61118-61122
FR Document		2015-25690

This regulation establishes an exemption from the requirement of a tolerance for residues of trans-1,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No. 29118-24-9) when used as an inert ingredient (propellant) in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, and animals, and when used as an inert ingredient in antimicrobial pesticide formulations for food-contact surface sanitizing solutions. The Acta Group, L.L.C. on behalf of Honeywell International, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of trans-1,3,3,3-tetrafluoroprop-1-ene.

Federal Register, Volume 80 Issue 196 (Friday, October 9, 2015)

[Federal Register Volume 80, Number 196 (Friday, October 9, 2015)]
[Rules and Regulations]
[Pages 61118-61122]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-25690]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0043; FRL-9934-74]

Trans-1,3,3,3-tetrafluoroprop-1-ene; Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of trans-1,3,3,3-tetrafluoroprop-1-ene (CAS
Reg. No. 29118-24-9) when used as an inert ingredient (propellant) in
pesticide formulations applied to growing crops, raw agricultural
commodities after harvest, and animals, and when used as an inert
ingredient in antimicrobial pesticide formulations for food-contact
surface sanitizing solutions. The Acta Group, L.L.C. on behalf of
Honeywell International, Inc. submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment
of an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of trans-1,3,3,3-tetrafluoroprop-1-ene.

DATES: This regulation is effective October 9, 2015. Objections and
requests for hearings must be received on or before December 8, 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-2012-0043, 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.,

[[Page 61119]]

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-2012-0043 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
December 8, 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 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-2012-0043, 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 April 4, 2012 (77 FR 20334) (FRL-9340-
4), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 1E7938) by The
Acta Group, L.L.C. (2200 Pennsylvania Avenue NW., Suite 100W,
Washington, DC 20037) on behalf of Honeywell International, Inc., 101
Columbia Road, Morristown, NJ 07962. The petition requested that 40 CFR
180.910, 180.930 and 180.940(a) be amended by establishing an exemption
from the requirement of a tolerance for residues of trans-1,3,3,3-
tetrafluoroprop-1-ene (CAS Reg. No. 29118-24-9) when used as an inert
ingredient (propellant) in pesticide formulations applied to growing
crops, raw agricultural commodities after harvest, and animals, and
when used as an inert ingredient in antimicrobial pesticide
formulations for food-contact surface sanitizing solutions,
respectively. That document referenced a summary of the petition
prepared by The Acta Group, L.L.C. on behalf of Honeywell
International, Inc., the petitioner, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to 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

[[Page 61120]]

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 trans-1,3,3,3-tetrafluoroprop-
1-ene including exposure resulting from the exemption established by
this action. EPA's assessment of exposures and risks associated with
trans-1,3,3,3-tetrafluoroprop-1-ene 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 trans-1,3,3,3-tetrafluoroprop-1-ene 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.
Acute inhalation toxicity is low for trans-1,3,3,3-tetrafluoroprop-
1-ene. Acute inhalation LD50s are >101,850 parts per million
(ppm); approximately 713 milligram/kilogram (mg/kg) in rats and mice.
Trans-1,3,3,3-tetrafluoroprop-1-ene is not a dermal irritant in rabbits
or a sensitizer in humans.
Two subchronic toxicity studies via the inhalation route of
exposure are available for trans-1,3,3,3-tetrafluoroprop-1-ene in
rodents. Toxicity is not observed in rats or mice at doses as high as
5,000 ppm (approximately equivalent to 7,800 milligram/kilogram/day
(mg/kg/day) human equivalent dose) following 13 weeks and 90 days of
exposure, respectively. The 90-day inhalation toxicity study in mice
also evaluated the carcinogenic potential of trans-1,3,3,3-
tetrafluoroprop-1-ene by conducting a toxicogenomic assessment. Trans-
1,3,3,3-tetrafluoroprop-1-ene is classified as non-carcinogenic by the
toxicogenomic assessment at 10,000 ppm (approximately equivalent to
15,600 mg/kg/day human equivalent dose), the highest dose tested (HDT).
Developmental toxicity studies via the inhalation route are
available in rats and rabbits. Neither maternal nor developmental
toxicity is observed in either study up to 15,000 ppm (approximately
equivalent to 23,400 mg/kg/day human equivalent dose), the HDT.
Two Ames Tests via gas exposure are available for review with
trans-1,3,3,3-tetrafluoroprop-1-ene. The mouse micronucleus assay was
performed via inhalation exposure. These tests are negative.
A chronic study with trans-1,3,3,3-tetrafluoroprop-1-ene is not
available for review. Although a chronic toxicity study is not
available, there is no concern for the lack of it because toxicity is
not seen following up to 13 weeks of exposure to trans-1,3,3,3-
tetrafluoroprop-1-ene at excessive doses (7,800 and 15,600 mg/kg/day).
Also, toxicity is not seen in the developmental study at an excessive
dose of 23,400 mg/kg/day. Therefore, the likelihood that chronic
exposure to doses below the limit dose will result in toxic effects is
highly unlikely.
Neurotoxicity studies are not available for review. However,
evidence of neurotoxicity is not observed in the submitted inhalation
studies.
Immunotoxicity studies are not available for review. However, very
slight mononuclear cell infiltrates in the heart are observed in only
females (3/5) at the LOAEL of =5,000 ppm (approximately
7,800 mg/kg/day human equivalent dose lowest dose tested) following 10
days of exposure via inhalation in Sprague Dawley rats. This effect is
not dose dependent with regard to either incidence or severity. Similar
effects along with increased monocyte count are observed in the heart
at 15,000 ppm (approximately 23,400 mg/kg/day human equivalent dose;
HDT) in a 13-week study via inhalation in Sprague Dawley rats. The
NOAEL is 5,000 ppm (equivalent to 7,800 mg/kg/day human equivalent
dose). This study included more rats, is conducted in the same species
of rats that underwent the same route of exposure and was of longer
duration (13 weeks vs 10 days). Mononuclear cell infiltrates in the
heart are not observed at 5,000 ppm (equivalent to 7,800 mg/kg/day
human equivalent dose) in either the male or female rat as was observed
in the 10-day study. Therefore, since the incidence and severity of
these effects are not dose-dependent in the 10-day study, the 13-week
study is considered more reflective of toxicity resulting from exposure
to trans-1,3,3,3-tetrafluoroprop-1-ene. However, the Agency is not
concerned about these effects since they occur well above the limit
dose and exposure above that is highly unlikely and unrealistic.
Two studies are available for trans-1,3,3,3-tetrafluoroprop-1-ene
on male rats and mice metabolism and pharmacokinetics. In rats and
mice, trans-1,3,3,3-tetrafluoroprop-1-ene via the inhalation route of
exposure is rapidly absorbed, metabolized and excreted. The urine is
the major route of excretion. In rats, the major metabolite is S-
(3,3,3-trifluoro-trans-propenyl)-mercaptolactic acid. In mice, the
major metabolite is a presumed amino acid conjugate of 3, 3, 3-
trifluoropropionic acid. Other identified metabolites are S-(3, 3, 3-
trifluoro-transpropenyl)-L-cysteine, N-acetyl-S-(3,3,3-trifluoro-trans-
propenyl)-L-cysteine and 3,3,3-trifluoropropionic acid.
Specific information on the studies received on trans-1,3,3,3-
tetrafluoroprop-1-ene 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, ``Trans-1,3,3,3-tetrafluoroprop-1-ene; 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-
2012-0043.

B. Toxicological Points of Departure/Levels of Concern

The available toxicity studies indicate that trans-1,3,3,3-
tetrafluoroprop-1-ene has very low overall toxicity. The lowest NOAEL
in the database was 5,000 ppm (approximately 7,800 mg/kg/day human
equivalent dose) observed in a 13 week toxicity study in rats via the
inhalation route of exposure. Since signs of toxicity were not observed
at well above the limit dose an endpoint of concern for risk assessment
purposes was not identified.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to trans-1,3,3,3-tetrafluoroprop-1-ene, EPA considered
exposure under the proposed exemption from the requirement of a
tolerance. EPA assessed dietary exposures from trans-1,3,3,3-
tetrafluoroprop-1-ene in food as follows:

[[Page 61121]]

The general population may be exposed via the diet to trans-
1,3,3,3-tetrafluoroprop-1-ene as a result of eating foods containing
residues of trans-1,3,3,3-tetrafluoroprop-1-ene. However, since a
hazard endpoint of concern was not identified for the acute and chronic
dietary assessment (food and drinking water), a dietary exposure risk
assessment was not conducted.
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).
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). Trans-1,3,3,3-tetrafluoroprop-1-ene may be used
as an inert ingredient in pesticide products that could result in
short- and intermediate-term residential exposure. However, based on
the lack of toxicity, a quantitative exposure assessment from
residential exposures was not performed.
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 trans-1,3,3,3-tetrafluoroprop-1-ene to share a
common mechanism of toxicity with any other substances, and trans-
1,3,3,3-tetrafluoroprop-1-ene does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that trans-1,3,3,3-
tetrafluoroprop-1-ene 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

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 the lack of
effects in subchronic and developmental toxicity studies, and an
assessment of trans-1,3,3,3-tetrafluoroprop-1-ene, 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 trans-1,3,3,3-
tetrafluoroprop-1-ene 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 trans-1,3,3,3-
tetrafluoroprop-1-ene 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 without any numerical limitation.

VI. Conclusions

Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910, 180.930 and 180.940(a) for trans-
1,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No. 29118-24-9) when used as an
inert ingredient (propellant) in pesticide formulations applied to
formulations applied to growing crops, raw agricultural commodities
after harvest, and animals, and when used as an inert ingredient in
antimicrobial pesticide formulations for food-contact surface
sanitizing solutions, respectively.

VII. Statutory and Executive Order Reviews

This action establishes 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 exemptions 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

[[Page 61122]]

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: October 1, 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. 180.910, add alphabetically the inert ingredient to the
table to read as follows:

Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

----------------------------------------------------------------------------------------------------------------
Inert ingredients Limits Uses
----------------------------------------------------------------------------------------------------------------

* * * * * * *
Trans-1,3,3,3-tetrafluoroprop-1-ene (CAS Reg. .................. Propellant.
No. 29118-24-9).

* * * * * * *
----------------------------------------------------------------------------------------------------------------

0
3. In Sec. 180.930 add alphabetically the inert ingredient to the
table to read as follows:

Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.

* * * * * * *
Trans-1,3,3,3-tetrafluoroprop-1-ene (CAS Reg. .................. Propellant.
No. 29118-24-9).

* * * * * * *
----------------------------------------------------------------------------------------------------------------

0
4. In Sec. 180.940(a), add alphabetically the inert ingredient to the
table to read as follows:

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

(a) * * *

----------------------------------------------------------------------------------------------------------------
Pesticide chemical CAS Reg. No. Limits
----------------------------------------------------------------------------------------------------------------

* * * * * * *
Trans-1,3,3,3-tetrafluoroprop-1-ene........... 29118-24-9 None.

* * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-25690 Filed 10-8-15; 8:45 am]
BILLING CODE 6560-50-P

61118 Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations

comment in response to the parallel Incorporation by reference, PART 52—[AMENDED]
notice of proposed rulemaking for this Intergovernmental relations, Lead,
action published in the proposed rules Nitrogen dioxide, Ozone, Particulate ■ 1. The authority citation for part 52
section of today’s Federal Register, matter, Reporting and recordkeeping continues to read as follows:
rather than file an immediate petition requirements, Sulfur oxides, Volatile Authority: 42 U.S.C. 7401 et seq.
for judicial review of this direct final organic compounds.
rule, so that EPA can withdraw this Subpart U—Maine
Dated: September 21, 2015.
direct final rule and address the
comment in the proposed rulemaking.
H. Curtis Spalding, ■ 2. In § 52.1020(c), the table is
This action may not be challenged later Regional Administrator, EPA New England. amended by adding new state citations
for Chapter 149 and Chapter 164 in
in proceedings to enforce its Part 52 of chapter I, title 40 of the numerical order and revising footnote 1
requirements. (See section 307(b)(2)) Code of Federal Regulations is amended to read as follows:
List of Subjects in 40 CFR Part 52 as follows:
§ 52.1020 Identification of plan.
Environmental protection, Air * * * * *
pollution control, Carbon monoxide, (c) * * *

EPA-APPROVED MAINE REGULATIONS
EPA approval date EPA
State effective
State citation Title/subject approval date Explanations
date and citation 1

* * * * * * *
Chapter 149 ............ General Permit Regulation for 04/27/2014 10/9/2015, [Insert Federal All of Chapter 149 is approved with the
Nonmetallic Mineral Proc- Register citation]. exception of the ‘‘director discretion’’
essing Plants. provisions in sections 5(A)(8),
5(A)(9)(a), and 5(A)(9)(b), and the
opacity provisions in sections
5(A)(15), 5(C)(7), and 5(E), which
were formally withdrawn from consid-
eration as part of the SIP.

* * * * * * *
Chapter 164 ............ General Permit Regulation for 04/27/2014 10/9/2015, [Insert Federal All of Chapter 164 is approved with the
Concrete Batch Plants. Register citation]. exception of the ‘‘director discretion’’
provisions in sections 5(C)(2),
5(C)(3)(a), and 5(C)(3)(b), and the
opacity provisions in sections
5(A)(10), 5(B)(3), 5(B)(4), 5(E),
5(F)(5) and 5(G)(4), which were for-
mally withdrawn from consideration
as part of the SIP.

* * * * * * *
1 In
order to determine the EPA effective date for a specific provision listed in this table, consult the Federal Register notice cited in this col-
umn for the particular provision.

[FR Doc. 2015–25446 Filed 10–8–15; 8:45 am] tetrafluoroprop-1-ene (CAS Reg. No. DATES: This regulation is effective
BILLING CODE 6560–50–P 29118–24–9) when used as an inert October 9, 2015. Objections and
ingredient (propellant) in pesticide requests for hearings must be received
formulations applied to growing crops, on or before December 8, 2015, and
ENVIRONMENTAL PROTECTION raw agricultural commodities after must be filed in accordance with the
AGENCY harvest, and animals, and when used as instructions provided in 40 CFR part
an inert ingredient in antimicrobial 178 (see also Unit I.C. of the
40 CFR Part 180 SUPPLEMENTARY INFORMATION).
pesticide formulations for food-contact
[EPA–HQ–OPP–2012–0043; FRL–9934–74] surface sanitizing solutions. The Acta ADDRESSES: The docket for this action,
Group, L.L.C. on behalf of Honeywell identified by docket identification (ID)
Trans-1,3,3,3-tetrafluoroprop-1-ene; International, Inc. submitted a petition number EPA–HQ–OPP–2012–0043, is
Exemption From the Requirement of a to EPA under the Federal Food, Drug, available at http://www.regulations.gov
Tolerance and Cosmetic Act (FFDCA), requesting or at the Office of Pesticide Programs
establishment of an exemption from the Regulatory Public Docket (OPP Docket)
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AGENCY: Environmental Protection
Agency (EPA). requirement of a tolerance. This in the Environmental Protection Agency
ACTION: Final rule.
regulation eliminates the need to Docket Center (EPA/DC), West William
establish a maximum permissible level Jefferson Clinton Bldg., Rm. 3334, 1301
SUMMARY: This regulation establishes an for residues of trans-1,3,3,3- Constitution Ave. NW., Washington, DC
exemption from the requirement of a tetrafluoroprop-1-ene. 20460–0001. The Public Reading Room
tolerance for residues of trans-1,3,3,3- is open from 8:30 a.m. to 4:30 p.m.,

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Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations 61119

Monday through Friday, excluding legal and hearing requests are provided in 40 There were no comments received in
holidays. The telephone number for the CFR 178.25(b). response to the notice of filing.
Public Reading Room is (202) 566–1744, In addition to filing an objection or III. Inert Ingredient Definition
and the telephone number for the OPP hearing request with the Hearing Clerk
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please Inert ingredients are all ingredients
the visitor instructions and additional submit a copy of the filing (excluding that are not active ingredients as defined
information about the docket available any Confidential Business Information in 40 CFR 153.125 and include, but are
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. not limited to, the following types of
FOR FURTHER INFORMATION CONTACT: Information not marked confidential ingredients (except when they have a
Susan Lewis, Registration Division pursuant to 40 CFR part 2 may be pesticidal efficacy of their own):
(7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior Solvents such as alcohols and
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your hydrocarbons; surfactants such as
Pennsylvania Ave. NW., Washington, objection or hearing request, identified polyoxyethylene polymers and fatty
by docket ID number EPA–HQ–OPP– acids; carriers such as clay and
DC 20460–0001; main telephone
2012–0043, by one of the following diatomaceous earth; thickeners such as
number: (703) 305–7090; email address:
methods: carrageenan and modified cellulose;
RDFRNotices@epa.gov.
• Federal eRulemaking Portal: http:// wetting, spreading, and dispersing
SUPPLEMENTARY INFORMATION: agents; propellants in aerosol
www.regulations.gov. Follow the online
I. General Information dispensers; microencapsulating agents;
instructions for submitting comments.
and emulsifiers. The term ‘‘inert’’ is not
A. Does this action apply to me? Do not submit electronically any
intended to imply nontoxicity; the
information you consider to be CBI or
You may be potentially affected by ingredient may or may not be
other information whose disclosure is
this action if you are an agricultural chemically active. Generally, EPA has
restricted by statute.
producer, food manufacturer, or exempted inert ingredients from the
• Mail: OPP Docket, Environmental requirement of a tolerance based on the
pesticide manufacturer. The following
Protection Agency Docket Center (EPA/ low toxicity of the individual inert
list of North American Industrial
DC), (28221T), 1200 Pennsylvania Ave. ingredients.
Classification System (NAICS) codes is
NW., Washington, DC 20460–0001.
not intended to be exhaustive, but rather
• Hand Delivery: To make special IV. Aggregate Risk Assessment and
provides a guide to help readers Determination of Safety
arrangements for hand delivery or
determine whether this document
delivery of boxed information, please Section 408(c)(2)(A)(i) of FFDCA
applies to them. Potentially affected
follow the instructions at http:// allows EPA to establish an exemption
entities may include:
• Crop production (NAICS code 111). www.epa.gov/dockets/contacts.html. from the requirement for a tolerance (the
• Animal production (NAICS code Additional instructions on legal limit for a pesticide chemical
112). commenting or visiting the docket, residue in or on a food) only if EPA
• Food manufacturing (NAICS code along with more information about determines that the tolerance is ‘‘safe.’’
311). dockets generally, is available at http:// Section 408(b)(2)(A)(ii) of FFDCA
• Pesticide manufacturing (NAICS www.epa.gov/dockets. defines ‘‘safe’’ to mean that ‘‘there is a
code 32532). reasonable certainty that no harm will
II. Petition for Exemption
result from aggregate exposure to the
B. How can I get electronic access to In the Federal Register of April 4, pesticide chemical residue, including
other related information? 2012 (77 FR 20334) (FRL–9340–4), EPA all anticipated dietary exposures and all
You may access a frequently updated issued a document pursuant to FFDCA other exposures for which there is
electronic version of 40 CFR part 180 section 408, 21 U.S.C. 346a, announcing reliable information.’’ This includes
through the Government Printing the filing of a pesticide petition (PP exposure through drinking water and in
Office’s e-CFR site at http:// 1E7938) by The Acta Group, L.L.C. residential settings, but does not include
www.ecfr.gov/cgi-bin/text- (2200 Pennsylvania Avenue NW., Suite occupational exposure. Section
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 100W, Washington, DC 20037) on behalf 408(b)(2)(C) of FFDCA requires EPA to
40tab_02.tpl. of Honeywell International, Inc., 101 give special consideration to exposure
Columbia Road, Morristown, NJ 07962. of infants and children to the pesticide
C. How can I file an objection or hearing The petition requested that 40 CFR chemical residue in establishing a
request? 180.910, 180.930 and 180.940(a) be tolerance and to ‘‘ensure that there is a
Under FFDCA section 408(g), 21 amended by establishing an exemption reasonable certainty that no harm will
U.S.C. 346a, any person may file an from the requirement of a tolerance for result to infants and children from
objection to any aspect of this regulation residues of trans-1,3,3,3-tetrafluoroprop- aggregate exposure to the pesticide
and may also request a hearing on those 1-ene (CAS Reg. No. 29118–24–9) when chemical residue. . . .’’
objections. You must file your objection used as an inert ingredient (propellant) EPA establishes exemptions from the
or request a hearing on this regulation in pesticide formulations applied to requirement of a tolerance only in those
in accordance with the instructions growing crops, raw agricultural cases where it can be clearly
provided in 40 CFR part 178. To ensure commodities after harvest, and animals, demonstrated that the risks from
proper receipt by EPA, you must and when used as an inert ingredient in aggregate exposure to pesticide
identify docket ID number EPA–HQ– antimicrobial pesticide formulations for chemical residues under reasonably
OPP–2012–0043 in the subject line on food-contact surface sanitizing foreseeable circumstances will pose no
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the first page of your submission. All solutions, respectively. That document appreciable risks to human health. In
objections and requests for a hearing referenced a summary of the petition order to determine the risks from
must be in writing, and must be prepared by The Acta Group, L.L.C. on aggregate exposure to pesticide inert
received by the Hearing Clerk on or behalf of Honeywell International, Inc., ingredients, the Agency considers the
before December 8, 2015. Addresses for the petitioner, which is available in the toxicity of the inert in conjunction with
mail and hand delivery of objections docket, http://www.regulations.gov. possible exposure to residues of the

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61122 Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations

contain any unfunded mandate as Representatives, and the Comptroller PART 180—[AMENDED]
described under Title II of the Unfunded General of the United States prior to
Mandates Reform Act (UMRA) (2 U.S.C. publication of the rule in the Federal ■ 1. The authority citation for part 180
1501 et seq.). Register. This action is not a ‘‘major continues to read as follows:
This action does not involve any rule’’ as defined by 5 U.S.C. 804(2).
Authority: 21 U.S.C. 321(q), 346a and 371.
technical standards that would require List of Subjects in 40 CFR Part 180
Agency consideration of voluntary ■ 2. In § 180.910, add alphabetically the
consensus standards pursuant to section Environmental protection, inert ingredient to the table to read as
Administrative practice and procedure,
12(d) of the National Technology follows:
Agricultural commodities, Pesticides
Transfer and Advancement Act
and pests, Reporting and recordkeeping § 180.910 Inert ingredients used pre- and
(NTTAA) (15 U.S.C. 272 note).
requirements. post-harvest; exemptions from the
VIII. Congressional Review Act Dated: October 1, 2015. requirement of a tolerance.
Pursuant to the Congressional Review Susan Lewis,
Act (5 U.S.C. 801 et seq.), EPA will Director, Registration Division, Office of
submit a report containing this rule and Pesticide Programs.
other required information to the U.S. Therefore, 40 CFR chapter I is
Senate, the U.S. House of amended as follows:

Inert ingredients Limits Uses

* * * * * * *
Trans-1,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No. 29118–24–9) ....................................................... .............................. Propellant.

* * * * * * *

■ 3. In § 180.930 add alphabetically the § 180.930 Inert ingredients applied to
inert ingredient to the table to read as animals; exemptions from the requirement
follows: of a tolerance.

Inert ingredients Limits Uses

* * * * * * *
Trans-1,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No. 29118–24–9) ....................................................... .............................. Propellant.

* * * * * * *

■ 4. In § 180.940(a), add alphabetically § 180.940 Tolerance exemptions for active
the inert ingredient to the table to read and inert ingredients for use in
antimicrobial formulations (Food-contact
as follows:
surface sanitizing solution).
(a) * * *

Pesticide chemical CAS Reg. No. Limits

* * * * * * *
Trans-1,3,3,3-tetrafluoroprop-1-ene ....................................................................................................... 29118–24–9 None.

* * * * * * *

* * * * * ENVIRONMENTAL PROTECTION SUMMARY: This regulation establishes an
[FR Doc. 2015–25690 Filed 10–8–15; 8:45 am] AGENCY exemption from the requirement of a
BILLING CODE 6560–50–P tolerance for residues of cellulose
40 CFR Part 180 carboxymethyl ether, potassium salt;
when used as an inert ingredient in a
[EPA–HQ–OPP–2015–0482; FRL–9934–45] pesticide chemical formulation. Spring
Trading Company on behalf of Lamberti
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Cellulose Carboxymethyl Ether, USA, Incorporated submitted a petition
Potassium Salt; Tolerance Exemption to EPA under the Federal Food, Drug,
AGENCY: Environmental Protection and Cosmetic Act (FFDCA), requesting
Agency (EPA). an exemption from the requirement of a
tolerance. This regulation eliminates the
ACTION: Final rule.
need to establish a maximum

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Document Created: 2015-12-15 08:34:19
Document Modified: 2015-12-15 08:34:19

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective October 9, 2015. Objections and requests for hearings must be received on or before December 8, 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).
Contact		Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		80 FR 61118
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements