a-Terpineol (CAS No. 98-55-5); Tolerance Exemption, 71388-71391 [2021-27179]
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Federal Register / Vol. 86, No. 239 / Thursday, December 16, 2021 / Rules and Regulations
sections 172 and 182 of the CAA, and/
or the OTR requirements under section
184 of the CAA. No tribe is subject to
the requirement to submit an
implementation plan under section 172
or under subpart 2 of part D of Title I
of the CAA. Thus, Executive Order
13175 does not apply to this action.
G. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
The EPA interprets Executive Order
13045 as applying only to those
regulatory actions that concern health or
safety risks that the EPA has reason to
believe may disproportionately affect
children, per the definition of ‘‘covered
regulatory action’’ in section 2–202 of
the Executive Order. This action is not
subject to Executive Order 13045
because it is a finding that several states
failed to submit SIP revisions that
satisfy the nonattainment area planning
requirements under sections 172 and
182 of the CAA, and/or the OTR
requirements under Section 184, and
does not directly or disproportionately
affect children.
HI. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution or Use
This action is not subject to Executive
Order 13211, because it is not a
significant regulatory action under
Executive Order 12866.
IJ. National Technology Transfer and
Advancement Act (NTTAA)
This rulemaking does not involve
technical standards.
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J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
The EPA believes the human health or
environmental risk addressed by this
action will not have potential
disproportionately high and adverse
human health or environmental effects
on minority, low-income, or indigenous
populations. In finding that two states
have failed to submit SIP revisions that
satisfy the nonattainment area planning
requirements under sections 172 and
182 of the CAA, and/or the OTR
requirements under section 184 of the
CAA, this action does not directly affect
the level of protection provided to
human health or the environment.
K. Congressional Review Act (CRA)
This action is subject to the CRA, and
the EPA will submit a rule report to
each House of the Congress and to the
Comptroller General of the United
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States. This action is not a ‘‘major rule’’
as defined by 5 U.S.C. 804(2).
Reporting and recordkeeping
requirements.
L. Judicial Review
Section 307(b)(1) of the CAA indicates
which Federal Courts of Appeal have
venue for petitions of review of final
actions by the EPA under the CAA. This
section provides, in part, that petitions
for review must be filed in the United
States Court of Appeals for the District
of Columbia Circuit if (i) the agency
action consists of ‘‘nationally applicable
regulations promulgated, or final actions
taken, by the Administrator,’’ or (ii)
such action is locally or regionally
applicable, but ‘‘such action is based on
a determination of nationwide scope or
effect and if in taking such action the
Administrator finds and publishes that
such action is based on such a
determination.’’
This final action is nationally
applicable. To the extent a court finds
this final action to be locally or
regionally applicable, the EPA finds that
this action is based on a determination
of ‘‘nationwide scope or effect’’ within
the meaning of CAA section 307(b)(1).
This final action consists of findings of
failure to submit required SIPs from two
states in the OTR, one with a Moderate
nonattainment area, located in two of
the ten EPA Regions, and in two
different federal judicial circuits. This
final action is also based on a common
core of factual findings concerning the
receipt and completeness of the relevant
SIP submittals. For these reasons, this
final action is nationally applicable or,
alternatively, to the extent a court finds
this action to be locally or regionally
applicable, the Administrator has
determined that this final action is
based on a determination of nationwide
scope or effect for purposes of CAA
section 307(b)(1).
Under section 307(b)(1) of the CAA,
petitions for judicial review of this
action must be filed in the United States
Court of Appeals for the District of
Columbia Circuit within 60 days from
the date this final action is published in
the Federal Register. Filing a petition
for reconsideration by the Administrator
of this final action does not affect the
finality of the action for the purposes of
judicial review, nor does it extend the
time within which a petition for judicial
review must be filed, and shall not
postpone the effectiveness of such rule
or action.
Michael S. Regan,
Administrator.
List of Subjects in 40 CFR Part 52
Environmental protection,
Administrative practice and procedures,
Air pollution control, Approval and
promulgation of implementation plans,
Intergovernmental relations, and
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[FR Doc. 2021–27213 Filed 12–15–21; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2021–0659; FRL–9322–01–
OCSPP]
α-Terpineol (CAS No. 98–55–5);
Tolerance Exemption
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of a-terpineol
(CAS No. 98–55–5) when used as a
solvent inert ingredient in pesticide
formulations at rates of 5% of the
formulation in pre-harvest applications
to crops. Landis International, Inc., on
behalf of Morse Enterprises Limited,
Inc. d/b/a KeyPlex submitted a petition
to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), requesting
an exemption from the requirement of a
tolerance. This regulation eliminates the
need to establish a maximum
permissible level for residues of aterpineol (CAS No. 98–55–5) on food or
feed commodities when used in
accordance with this exemption.
DATES: This regulation is effective
December 16, 2021. Objections and
requests for hearings must be received
on or before February 14, 2022, 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–2021–0659, is
available at https://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.
Due to the public health concerns
related to COVID–19, the EPA Docket
Center (EPA/DC) and Reading Room is
closed to visitors with limited
exceptions. The staff continues to
provide remote customer service via
email, phone, and webform. For the
latest status information on EPA/DC
SUMMARY:
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services and docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael 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:
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 Office of the Federal
Register’s e-CFR site at https://
www.ecfr.gov/current/title-40.
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C. Can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a(g), any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. 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–2021–0659 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 February 14, 2022. 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.
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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–
2021–0659, by one of the following
methods.
• Federal eRulemaking Portal:
https://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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of October 21,
2021 (86 FR 58239) (FRL–8792–04),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the receipt of a pesticide
petition (PP IN–11083) filed by Landis
International, Inc., on behalf of Morse
Enterprises Limited, Inc. d/b/a KeyPlex
(P.O. Box 2515, Winter Park, FL 32790).
The petition requested that 40 CFR
180.920 be amended by establishing an
exemption from the requirement of a
tolerance for residues of a-terpineol
(CAS No. 98–55–5) when used as a
solvent inert ingredient in pesticide
formulations at rates not exceeding 5%
of the formulation when applied preharvest to crops. That document
included a summary of the petition
prepared by the petitioner and solicited
comments on the petitioner’s request.
The Agency did not receive any public
comments.
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
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71389
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 the FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the exemption is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of the FFDCA
defines ‘‘safe’’ to mean that EPA has
determined 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 it 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 an
exemption 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 shown that the
risks from aggregate exposure to
pesticide chemical residues under
reasonably foreseeable circumstances
will pose no harm 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 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 and considered its
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validity, completeness and reliability
and the relationship of this information
to human risk. EPA has also considered
available information concerning the
variability of the sensitivities of major
identifiable subgroups of consumers,
including infants and children. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure to a-terpineol,
including exposure resulting from the
exemption established by this action.
EPA’s assessment of exposures and risks
associated with a-terpineol follows.
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A. Toxicological Profile
The acute oral and dermal toxicity of
a-terpineol and related compounds is
low. The acute oral LD50 (lethal dose) in
rats is 2,830 milligrams/kilogram (mg/
kg) for a-terpineol and 4,300 mg/kg for
an a-terpineol/b-terpineol mixture. The
dermal LD50 in rabbits for terpineol is
>3,000 mg/kg. No acute inhalation,
primary eye irritation or dermal
sensitization studies are available in the
database.
The repeated-dose toxicity for aterpineol and related compounds is low.
The only effects observed (decreased
food intake, increased cholesterol and
increased triacylglycerol) occurred at
the limit dose following treatment with
a-terpineol for 14 days. No adverse
effects were observed in a 20-week rat
study with a-terpenyl acetate or in a
combined repeated dose with
reproduction/developmental screening
study in rats with terpineol.
No oral chronic or carcinogenicity
studies are available for a-terpineol.
However, there are no structural alerts
for carcinogenicity for a-terpineol and
there was no evidence of increased lung
tumor incidence in mice treated
intraperitoneally with a-terpineol for 20
weeks, when compared to controls.
There is also low concern for
genotoxicity or mutagenicity, based on
negative results in mammalian
genotoxicity tests and most Ames tests.
Neurotoxicity and immunotoxicity
toxicity studies are not available for
review. However, no evidence of
neurotoxicity or immunotoxicity is seen
in the available studies.
B. Toxicological Points of Departure/
Levels of Concern
No toxicological endpoint of concern
for a-terpineol has been identified in the
database.
C. Exposure Assessment
1. Dietary exposure. Dietary exposure
(food and drinking water) may occur
from the proposed uses of a-terpineol
(e.g., eating foods treated with pesticide
formulations containing a-terpineol,
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and drinking water exposures). There is
also potential for non-pesticide dietary
exposure since a-terpineol is a natural
constituent of orange juice and is also
used as a food additive. However, no
endpoint of concern was identified.
Therefore, an acute or chronic dietary
exposure assessment is not necessary for
a-terpineol.
2. Residential exposure. The proposed
pre-harvest use of a-terpineol in crops is
not anticipated to result in residential
exposure. Residential exposure to aterpineol may occur from existing
pesticide uses as well as from nonpesticide products that may be used in
and around the home, such as
cosmetics, perfumes, toiletries, and
cleaning products. However, based on
the absence of a toxicological endpoint
of concern, a quantitative assessment for
residential exposure 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 or exemption, 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 made a common
mechanism of toxicity finding as to aterpineol and any other substances and
a-terpineol does not appear to produce
a toxic metabolite produced by other
substances. For the purposes of this
action, therefore, EPA has not assumed
that a-terpineol has a common
mechanism of toxicity with other
substances. For information regarding
EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
Section 408(b)(2)(C) of FFDCA
provides that EPA shall apply an
additional tenfold 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 unless
EPA concludes that a different margin of
safety will be safe for infants and
children. 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 low toxicity of a-terpineol
in the available studies, EPA has
concluded that there are no
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toxicological endpoints of concern for
the U.S. population, including infants
and children.
E. Aggregate Risks and Determination of
Safety
Taking into consideration all available
information on a-terpineol, EPA has
determined that there is a reasonable
certainty that no harm to the general
population or any population subgroup,
including infants and children, will
result from aggregate exposure to aterpineol residues. Therefore, the
establishment of an exemption from the
requirement of a tolerance under 40 CFR
180.920 for residues of a-terpineol when
used as a solvent inert ingredient in
pesticide formulations at rates of 5% of
the formulation in pre-harvest
applications to crops is safe under
FFDCA section 408.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is not establishing a numerical
tolerance for residues of a-terpineol in
or on any food commodities. EPA is
establishing a limitation on the amount
of a-terpineol that may be used in
pesticide formulations applied preharvest. This 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 pesticide formulation
for food use that exceeds 5% a-terpineol
in the final pesticide formulation.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
Codex is a joint United Nations Food
and Agriculture Organization/World
Health Organization food standards
program, and it is recognized as an
international food safety standardssetting organization in trade agreements
to which the United States is a party.
EPA may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for a-terpineol.
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VI. Conclusion
Taking into consideration all available
information on a-terpineol, EPA has
determined that there is a reasonable
certainty that no harm to the general
population or any population subgroup,
including infants and children, will
result from aggregate exposure to aterpineol residues. Therefore, an
exemption from the requirement of a
tolerance is established under 40 CFR
180.920 for a-terpineol when used as an
inert ingredient at no more than 5% of
the total pesticide formulation.
VII. Statutory and Executive Order
Reviews
This action establishes an exemption
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 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 recordkeeping
requirements.
Dated: December 10, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.920, amend the table by
adding a table heading and in
alphabetical order the inert ingredient
‘‘a-terpineol (CAS Reg. No. 98–55–5)’’ to
read as follows:
■
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
*
*
*
*
*
TABLE 1 TO 180.920
Inert ingredients
Limits
*
*
*
a-terpineol (CAS Reg. No. 98–55–5) ..........................................
*
*
*
Not to exceed 5% in pesticide formulations ................................
*
*
*
*
Uses
*
*
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*
Solvent.
*
]]>Agencies
[Federal Register Volume 86, Number 239 (Thursday, December 16, 2021)]
[Rules and Regulations]
[Pages 71388-71391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27179]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0659; FRL-9322-01-OCSPP]
a-Terpineol (CAS No. 98-55-5); Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of [alpha]-terpineol (CAS No. 98-55-5) when
used as a solvent inert ingredient in pesticide formulations at rates
of 5% of the formulation in pre-harvest applications to crops. Landis
International, Inc., on behalf of Morse Enterprises Limited, Inc. d/b/a
KeyPlex submitted a petition to EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of [alpha]-terpineol (CAS No. 98-55-5)
on food or feed commodities when used in accordance with this
exemption.
DATES: This regulation is effective December 16, 2021. Objections and
requests for hearings must be received on or before February 14, 2022,
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-2021-0659, is available at
https://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.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC
[[Page 71389]]
services and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael 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: [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 Office of the Federal Register's e-CFR site at
https://www.ecfr.gov/current/title-40.
C. Can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. 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-2021-0659 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
February 14, 2022. 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-2021-0659, by one of
the following methods.
Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of October 21, 2021 (86 FR 58239) (FRL-
8792-04), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-
11083) filed by Landis International, Inc., on behalf of Morse
Enterprises Limited, Inc. d/b/a KeyPlex (P.O. Box 2515, Winter Park, FL
32790). The petition requested that 40 CFR 180.920 be amended by
establishing an exemption from the requirement of a tolerance for
residues of [alpha]-terpineol (CAS No. 98-55-5) when used as a solvent
inert ingredient in pesticide formulations at rates not exceeding 5% of
the formulation when applied pre-harvest to crops. That document
included a summary of the petition prepared by the petitioner and
solicited comments on the petitioner's request. The Agency did not
receive any public comments.
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 the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA
defines ``safe'' to mean that EPA has determined 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 it 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 an exemption 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 shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no harm 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
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 and considered its
[[Page 71390]]
validity, completeness and reliability and the relationship of this
information to human risk. EPA has also considered available
information concerning the variability of the sensitivities of major
identifiable subgroups of consumers, including infants and children.
EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure to [alpha]-terpineol, including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with [alpha]-terpineol
follows.
A. Toxicological Profile
The acute oral and dermal toxicity of [alpha]-terpineol and related
compounds is low. The acute oral LD50 (lethal dose) in rats
is 2,830 milligrams/kilogram (mg/kg) for [alpha]-terpineol and 4,300
mg/kg for an [alpha]-terpineol/[beta]-terpineol mixture. The dermal
LD50 in rabbits for terpineol is >3,000 mg/kg. No acute
inhalation, primary eye irritation or dermal sensitization studies are
available in the database.
The repeated-dose toxicity for [alpha]-terpineol and related
compounds is low. The only effects observed (decreased food intake,
increased cholesterol and increased triacylglycerol) occurred at the
limit dose following treatment with [alpha]-terpineol for 14 days. No
adverse effects were observed in a 20-week rat study with [alpha]-
terpenyl acetate or in a combined repeated dose with reproduction/
developmental screening study in rats with terpineol.
No oral chronic or carcinogenicity studies are available for
[alpha]-terpineol. However, there are no structural alerts for
carcinogenicity for [alpha]-terpineol and there was no evidence of
increased lung tumor incidence in mice treated intraperitoneally with
[alpha]-terpineol for 20 weeks, when compared to controls. There is
also low concern for genotoxicity or mutagenicity, based on negative
results in mammalian genotoxicity tests and most Ames tests.
Neurotoxicity and immunotoxicity toxicity studies are not available
for review. However, no evidence of neurotoxicity or immunotoxicity is
seen in the available studies.
B. Toxicological Points of Departure/Levels of Concern
No toxicological endpoint of concern for [alpha]-terpineol has been
identified in the database.
C. Exposure Assessment
1. Dietary exposure. Dietary exposure (food and drinking water) may
occur from the proposed uses of [alpha]-terpineol (e.g., eating foods
treated with pesticide formulations containing [alpha]-terpineol, and
drinking water exposures). There is also potential for non-pesticide
dietary exposure since [alpha]-terpineol is a natural constituent of
orange juice and is also used as a food additive. However, no endpoint
of concern was identified. Therefore, an acute or chronic dietary
exposure assessment is not necessary for [alpha]-terpineol.
2. Residential exposure. The proposed pre-harvest use of [alpha]-
terpineol in crops is not anticipated to result in residential
exposure. Residential exposure to [alpha]-terpineol may occur from
existing pesticide uses as well as from non-pesticide products that may
be used in and around the home, such as cosmetics, perfumes,
toiletries, and cleaning products. However, based on the absence of a
toxicological endpoint of concern, a quantitative assessment for
residential exposure 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 or
exemption, 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 made a common mechanism of toxicity finding as to
[alpha]-terpineol and any other substances and [alpha]-terpineol does
not appear to produce a toxic metabolite produced by other substances.
For the purposes of this action, therefore, EPA has not assumed that
[alpha]-terpineol has a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold 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 unless EPA concludes that
a different margin of safety will be safe for infants and children. 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 low toxicity
of [alpha]-terpineol in the available studies, 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
Taking into consideration all available information on [alpha]-
terpineol, EPA has determined that there is a reasonable certainty that
no harm to the general population or any population subgroup, including
infants and children, will result from aggregate exposure to [alpha]-
terpineol residues. Therefore, the establishment of an exemption from
the requirement of a tolerance under 40 CFR 180.920 for residues of
[alpha]-terpineol when used as a solvent inert ingredient in pesticide
formulations at rates of 5% of the formulation in pre-harvest
applications to crops is safe under FFDCA section 408.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
[alpha]-terpineol in or on any food commodities. EPA is establishing a
limitation on the amount of [alpha]-terpineol that may be used in
pesticide formulations applied pre-harvest. This 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 pesticide formulation for food use
that exceeds 5% [alpha]-terpineol in the final pesticide formulation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). Codex is a joint United Nations Food and Agriculture
Organization/World Health Organization food standards program, and it
is recognized as an international food safety standards-setting
organization in trade agreements to which the United States is a party.
EPA may establish a tolerance that is different from a Codex MRL;
however, FFDCA section 408(b)(4) requires that EPA explain the reasons
for departing from the Codex level.
The Codex has not established a MRL for [alpha]-terpineol.
[[Page 71391]]
VI. Conclusion
Taking into consideration all available information on [alpha]-
terpineol, EPA has determined that there is a reasonable certainty that
no harm to the general population or any population subgroup, including
infants and children, will result from aggregate exposure to [alpha]-
terpineol residues. Therefore, an exemption from the requirement of a
tolerance is established under 40 CFR 180.920 for [alpha]-terpineol
when used as an inert ingredient at no more than 5% of the total
pesticide formulation.
VII. Statutory and Executive Order Reviews
This action establishes an exemption 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 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
recordkeeping requirements.
Dated: December 10, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
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. 180.920, amend the table by adding a table heading and in
alphabetical order the inert ingredient ``[alpha]-terpineol (CAS Reg.
No. 98-55-5)'' to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
Table 1 to 180.920
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
[alpha]-terpineol (CAS Reg. Not to exceed 5% in Solvent.
No. 98-55-5). pesticide
formulations.
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2021-27179 Filed 12-15-21; 8:45 am]
BILLING CODE 6560-50-P
