Rule2022-09621
Trans-Anethole; Tolerance Exemption
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 5, 2022
Effective
May 5, 2022
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of trans-anethole (CAS No. 4180-23-8) when used as a fragrance inert ingredient in pesticide formulations at a concentration of 3% 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 trans- anethole (CAS No. 4180-23-8) on food or feed commodities when used in accordance with this exemption.
Full Text
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<title>Federal Register, Volume 87 Issue 87 (Thursday, May 5, 2022)</title>
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[Federal Register Volume 87, Number 87 (Thursday, May 5, 2022)]
[Rules and Regulations]
[Pages 26684-26687]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09621]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2018-0090; FRL-9763-01-OCSPP]
Trans-Anethole; Tolerance Exemption
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-anethole (CAS No. 4180-23-8) when
used as a fragrance inert ingredient in pesticide formulations at a
concentration of 3% 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 trans-
anethole (CAS No. 4180-23-8) on food or feed commodities when used in
accordance with this exemption.
DATES: This regulation is effective May 5, 2022. Objections and
requests for hearings must be received on or before July 5, 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-2018-0090, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 and OPP Docket is (202) 566-1744.
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 services and docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#a0f2e4e6f2eecfd4c9c3c5d3e0c5d0c18ec7cfd6"><span class="__cf_email__" data-cfemail="a2f0e6e4f0eccdd6cbc1c7d1e2c7d2c38cc5cdd4">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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 Federal Register's e-CFR site at <a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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-2018-0090 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
July 5, 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-2018-0090, by one of
the following methods.
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/contacts.html">https://www.epa.gov/dockets/contacts.html</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Petition for Exemption
In the Federal Register of April 11, 2018 (83 FR 15528) (FRL-9975-
57), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (PP IN-11093)
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 trans-
anethole (CAS No. 4180-23-8) when used as a fragrance inert ingredient
in pesticide formulations at a concentration of 3% 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
[[Page 26685]]
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 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 trans-anethole,
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with trans-
anethole follows.
A. Toxicological Profile
Trans-anethole has low acute toxicity via the oral, dermal, and
inhalation routes, and it is not an eye or dermal irritant, nor a skin
sensitizer. In repeated-dose toxicity studies, the liver was the major
target organ, with non-specific effects such as changes in body weight
and food consumption also observed in multiple studies. There is no
evidence of offspring susceptibility in the available developmental
toxicity study or in the 2-generation reproductive toxicity study. The
offspring effects observed in the developmental toxicity study occurred
at doses higher than those in which maternal toxicity was observed. The
uterine findings described in the 90-day oral study occurred only at
the highest dose tested and have a clear no observed adverse effect
level (NOAEL). No effects on reproductive parameters were observed in
the 2-generation reproductive toxicity study. Concern for
carcinogenicity is low, based on negative results in mutagenicity and
genotoxicity studies and lack of biological significance of the
neoplastic effects observed in females only at the highest dose tested
in the chronic/carcinogenicity study. There is no evidence of
neurotoxicity or immunotoxicity in the available studies.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern (LOCs) to use in evaluating the risk posed by human exposure to
the pesticide. For hazards that have a threshold below which there is
no appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see <a href="https://www.epa.gov/pesticides/factsheets/riskassess.htm">https://www.epa.gov/pesticides/factsheets/riskassess.htm</a>.
An acute dietary endpoint was not selected because no effect
attributable to a single dose was identified in the database. The
chronic dietary, incidental oral, dermal and inhalation endpoints are
all selected from the developmental toxicity study in rats, with a
NOAEL of 35 mg/kg/day and a LOAEL of 175 mg/kg/day, based on decreases
in maternal body weight and food consumption.
C. Exposure Assessment
1. Dietary exposure. Dietary exposure (food and drinking water) may
occur from the existing (non-food) and proposed uses of trans-anethole
(e.g., eating foods treated with pesticide formulations containing
trans-anethole, and drinking water exposures). There is also potential
for non-pesticide dietary exposure since trans-anethole is a natural
constituent of several food commodities (anise, fennel, thyme,
cinnamon, clove bud, nutmeg, pepper, coriander seed, and dill seed) and
is also used as a food additive (flavoring agent). An acute dietary
assessment was not performed due to the lack of adverse effects
attributed to a single dietary exposure. The chronic dietary exposure
for food and drinking water utilized 14.6% of the chronic PAD (cPAD)
for the U.S. population and 43.4% of the cPAD for children 1 to 2 years
old, the most highly exposed population. Therefore, chronic dietary
risks are not of concern, because they are less than 100% of the cPAD.
2. Residential exposure. The proposed pre-harvest use of trans-
anethole in crops is not anticipated to result in residential exposure.
Residential exposure to trans-anethole may occur from existing non-food
pesticide uses as
[[Page 26686]]
well as from non-pesticide products that may be used in and around the
home, such as toiletries. For residential handler short-term exposure
scenarios, MOEs ranged from 540 to 4,900,000, which are greater than
the LOC of 100 and therefore are not of concern. Residential handler
intermediate-term and long-term exposures are not expected because
applications are not expected to occur daily or for more than 30 days.
For residential post-application exposure scenarios (short- and
intermediate-term), MOEs ranged from 1,100 to 16,000,000, which are
greater than the LOC of 100 and therefore are not of concern.
3. Cumulative effects from substances with a common mechanism of
toxicity. Unlike pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to trans-anethole and any
other substances, and trans-anethole does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
action, therefore, EPA has assumed that trans-anethole does not have a
common mechanism of toxicity with other substances.
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.
Based on the evaluation of available toxicity studies, there is low
concern for pre- and postnatal susceptibility for infants and children
from exposure to trans-anethole. The FQPA safety factor has been
reduced to 1X because: (1) The toxicity database is adequate to
characterize potential pre- and postnatal risk for infants and
children; (2) no effects on reproductive organs or reproductive
parameters were observed in the available reproduction toxicity study;
(3) the developmental effects observed occurred at doses above which
maternal effects were seen, with clear NOAELs; (4) no evidence of
neurotoxicity was observed in the database; and (5) the assumptions for
the exposure assessment are unlikely to underestimate risk.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and cPAD. For linear cancer risks, EPA calculates the
lifetime probability of acquiring cancer given the estimated aggregate
exposure. Short-, intermediate-, and chronic-term risks are evaluated
by comparing the estimated aggregate food, water, and residential
exposure to the appropriate PODs to ensure that an adequate MOE exists.
1. Acute aggregate risk. An acute aggregate risk assessment takes
into account exposure estimates from acute dietary consumption of food
and drinking water. However, there was no hazard attributable to a
single exposure seen in the toxicity database for trans-anethole.
Therefore, trans-anethole is not expected to pose an acute aggregate
risk.
2. Short-term aggregate risk. Short-term aggregate exposure takes
into account short-term residential (dermal and inhalation) exposure
plus chronic dietary exposure (food and drinking water). The short-term
aggregate MOE is 490 for adults and 190 for children, which are greater
than the LOC of 100 and therefore are not of concern.
3. Intermediate-term aggregate risk. Intermediate-term aggregate
exposure takes into account intermediate-term residential (dermal and
inhalation) exposure plus chronic dietary exposure (food and drinking
water). The intermediate-term aggregate MOE is 710 for adults and 190
for children, which are greater than the LOC of 100 and therefore are
not of concern.
4. Chronic aggregate risk. A chronic aggregate risk assessment
takes into account exposure estimates from chronic dietary consumption
of food and drinking water. The chronic aggregate risk is equal to the
chronic dietary risk and is not of concern.
5. Aggregate cancer risk for U.S. population. EPA has not
identified any concerns for carcinogenicity relating to trans-anethole.
Therefore, a cancer aggregate assessment was not conducted.
6. Determination of safety. Taking into consideration all available
information on trans-anethole, 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 trans-anethole residues. Therefore, the
establishment of an exemption from the requirement of a tolerance under
40 CFR 180.920 for residues of trans-anethole when used as a fragrance
inert ingredient in pesticide formulations applied pre-harvest to crops
at a concentration of 3% of the formulation can be considered assessed
as safe under section 408 of the FFDCA.
VII. 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
trans-anethole in or on any food commodities. EPA is establishing a
limitation on the amount of trans-anethole 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 3% trans-anethole 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 trans-anethole.
VIII. Conclusion
Taking into consideration all available information on trans-
anethole, 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 trans-
anethole residues. Therefore, an exemption from the requirement of a
tolerance is established under 40 CFR 180.920 for trans-anethole when
used as an inert ingredient at no more than 3% of the total pesticide
formulation.
IX. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance
[[Page 26687]]
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).
X. 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: April 29, 2022.
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 Table 1 to 180.920 by adding in alphabetical
order an entry for ``Trans-anethole (CAS Reg. No. 4180-23-8)'' 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
------------------------------------------------------------------------
* * * * * * *
Trans-anethole (CAS Reg. No. Not to exceed 3% in Fragrance.
4180-23-8). pesticide
formulations.
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2022-09621 Filed 5-4-22; 8:45 am]
BILLING CODE 6560-50-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.