[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 [www.gpo.gov]
[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 
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. 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 https://www.epa.gov/dockets.

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 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-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: 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.
    <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 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 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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    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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