Document ID: EPA-HQ-OPP-2021-0659-0003
Agency: epa
Document Type: Rule
Title: Tolerance Exemption: a-Terpineol (CAS No. 98-55-5)
Posted Date: 2021-12-16T05:00Z

[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]

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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.

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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
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       Inert ingredients                Limits                Uses
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                              * * * * * * *
[alpha]-terpineol (CAS Reg.     Not to exceed 5% in    Solvent.
 No. 98-55-5).                   pesticide
                                 formulations.
 
                              * * * * * * *
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[FR Doc. 2021-27179 Filed 12-15-21; 8:45 am]
BILLING CODE 6560-50-P