[Federal Register Volume 83, Number 144 (Thursday, July 26, 2018)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15997]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
1,1-Difluoroethane; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation amends an exemption from the requirement of a
tolerance to allow for residues of 1,1-difluoroethane (CAS Reg. No. 75-
37-6) when used as an inert ingredient (aerosol propellant) in bird
repellent pesticide products applied to growing crops and raw
agricultural commodities after harvest and to animals. Pyxis Regulatory
Consulting, on behalf of Avian Enterprises Limited LLC, submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting an amendment to an existing requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of 1,1-difluoroethane when used in accordance with the
terms of the exemption.
DATES: This regulation is effective July 26, 2018. Objections and
requests for hearings must be received on or before September 24, 2018,
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-2018-0036, 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: Michael L. Goodis, 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:
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-2018-0036 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
September 24, 2018. 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-2018-0036, 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
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 21, 2018 (82 FR 12311) (FRL-9974-
76), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (IN-11082) by Pyxis
Regulatory Consulting (4110 136TH ST CT NW, Gig Harbor, WA 98332) on
behalf of Avian Enterprises Limited LLC (2000 Pontiac Drive, Sylvan
Lake, MI 48320). The petition requested that 40 CFR 180.910 and 40 CFR
180.930 be amended by modifying the current exemptions from the
requirement of a tolerance for residues of 1,1-difluoroethane (CAS Reg.
No. 75-37-6) when used as an inert ingredient (propellant) in pesticide
formulations applied to growing crops and to raw agricultural
commodities after harvest and to animals to allow for the additional
use in bird repellant pesticide formulations applied to growing crops,
raw agricultural commodities after harvest, and animals. That document
referenced a summary of the petition prepared by Pyxis Regulatory
Consulting on behalf of Avian Enterprises Limited LLC, the petitioner,
which is available in the docket, http://www.regulations.gov. No
relevant 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
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 1,1-difluoroethane including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with 1,1-difluoroethane
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 1,1-difluoroethane 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
In an acute inhalation toxicity study in rats for 1,1-
difluoroethane, the lethal concentration, LC50 is >475,500
parts per million (ppm) (oral equivalent approximately 235,399
No adverse toxic effects are observed in rats treated via
inhalation with 1,1-difluoroethane following subchronic exposure up to
100,000 ppm (oral equivalent approximately 82,600 mg/kg/day), chronic
exposure up to 25,000 ppm (oral equivalent approximately 20,649 mg/kg/
day) or developmental toxicity studies at doses up to 50,000 ppm (oral
equivalent approximately 41,300 mg/kg/day), the highest dose tested in
each exposure scenario.
Although reproduction toxicity studies are not available with 1,1-
difluoroethane, EPA does not expect 1,1-difluoroethane to cause any
reproductive toxicity effects. Fetal susceptibility was not observed in
the developmental toxicity study via inhalation with rats treated with
1,1-difluoroethane as neither maternal nor developmental toxicity is
observed up to 50,000 ppm (oral equivalent approximately 41,300 mg/kg/
day), the highest dose tested. Additionally, no signs of systemic
toxicity or reproduction organ toxicity are observed following
subchronic and chronic exposures at 100,000 ppm (oral equivalent
approximately 82,600 mg/kg/day) and 25,000 ppm (oral equivalent
approximately 20,649 mg/kg/day), the highest doses tested,
Toxicity is not observed in the carcinogenicity/chronic toxicity
study via inhalation with rats treated with 1,1-difluoroethane up to
25,000 ppm (oral equivalent approximately 20,649 mg/kg/day), the
highest dose tested. Therefore, 1,1-difluoroethane is not expected to
Mutagenicity studies are available with 1,1-difluoroethane. The
bacterial reverse mutation test and the micronucleus test were
negative. The mammalian chromosomal aberration test in human
lymphocytes gave a weak positive response and the sex-linked recessive
lethal test in Drosophila melanogaster gave a positive response.
Based on the submitted studies the mutagenic potential of 1,1-
difluoroethane is equivocal.
Neurotoxicity and immunotoxicity studies are not available for
review. However, evidence of neurotoxicity and immunotoxicity is not
observed in the submitted studies.
The metabolism study was conducted with difluoromethane which is
structurally similar to 1,1-difluoroethane. Difluoromethane differs
only by a carbon atom and is considered a suitable surrogate chemical
as it would be expected to be metabolized in a fashion similar to1,1-
difluoroethane. Therefore, data from the metabolism study conducted
with difluoromethane are used to describe 1,1-difluoroethane
metabolism. Based on the metabolism study in rats treated with
difluoromethane, 1,1-difluoroethane is expected to be poorly absorbed
and rapidly metabolized. Of the absorbed dose, most is expected to be
metabolized and excreted via exhaled carbon dioxide and organics
followed by excretion in the urine and feces.
B. Toxicological Points of Departure/Levels of Concern
The available toxicity studies indicate that 1,1-difluoroethane has
a very low overall toxicity. The lowest NOAEL in the database was
25,000 ppm (approximately 20,649 mg/kg/day human equivalent oral dose)
observed in a chronic/carcinogenicity toxicity study in rats via the
inhalation route of exposure. Since signs of toxicity were not observed
at levels well above the limit dose (1,000 mg/kg/day) an endpoint of
concern for risk assessment purposes was not identified. Therefore,
since no endpoint of concern was identified for the acute and chronic
dietary exposure assessment as well as for short- and intermediate-term
dermal and inhalation exposure, a qualitative risk assessment for 1,1-
difluoroethane was conducted.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to 1,1-difluoroethane, EPA considered exposure under the
proposed exemptions from the requirement of a tolerance, as well as the
existing exemptions and from other dietary sources of exposure. EPA
assessed dietary exposures from 1,1-difluoroethane in food as follows:
Dietary exposure (food) to 1,1-difluoroethane can occur following
ingestion of foods with residues from treated crops or animals or from
the use of 1,1-difluoroethane as an aerosol propellent in consumer
products used in or on food. However, a dietary exposure assessment was
not conducted since no endpoint of concern was identified in the
2. Dietary exposure from drinking water. Since a hazard endpoint of
concern was not identified for the acute and chronic dietary
assessment, a quantitative dietary exposure risk assessment for
drinking water was not conducted, although exposures may be expected
from use on food crops and runoff in the ground water.
3. 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).
1,1-Difluoroethane may be used in pesticide products and non-
pesticide products that may be used in and around the home. Based on
the discussion above, a quantitative residential exposure assessment
for 1,1-difluoroethane was not conducted.
4. 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.''
Based on the available data, 1,1-difluoroethane does not have a
toxic mechanism; therefore, section 408(b)(2)(D)(v) does not apply.
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 1,1-difluoroethane, 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 the exemptions from the requirement of a tolerance to
residues of 1,1-difluoroethane are safe, i.e., there is a reasonable
certainty that no harm will result to the general population, or to
infants and children, from aggregate exposure to 1,1-difluoroethane
V. 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.
Therefore, the exemptions from the requirement of a tolerance for
residues of 1,1-difluoroethane (CAS Reg. No. 75-37-6) contained in 40
CFR 180.910 and 180.930 are amended to add the use of 1,1-
difluoroethane in bird repellent pesticide formulations.
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), nor is
it considered a regulatory action subject to Executive Order 13771,
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82
FR 9339, February 3, 2017). 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
Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are amended on the basis of a
petition under FFDCA section 408(d), such as the tolerance 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
Dated: July 11, 2018.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.910, revise the inert ingredient ``1,1-Difluoroethane
(CAS Reg. No. 75-37-6)'' in 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
* * * * * * *
1,1-Difluoroethane (CAS Reg. In pesticide Aerosol
No. 75-37-6). formulations used for propellant.
insect control in
food- and feed-
animals; in bird
* * * * * * *
3. In Sec. 180.930, revise the inert ingredient 1,1-Difluoroethane
(CAS Reg. No. 75-37-6) in the table to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
Inert ingredients Limits Uses
* * * * * * *
1,1-Difluoroethane (CAS Reg. In pesticide Aerosol
No. 75-37-6). formulations used for propellant.
insect control in
food- and feed-
animals; in bird
* * * * * * *
[FR Doc. 2018-15997 Filed 7-25-18; 8:45 am]
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