Rule2022-20041
Eugenol; Exemption From the Requirement of a Tolerance
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
September 16, 2022
Effective
September 16, 2022
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of eugenol (2-methoxy-4-(-2- propenyl)phenol) in or on all food commodities when used in accordance with good agricultural practices. SciReg, Inc., on behalf of Eden Research PLC, 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 eugenol when used in accordance with this exemption.
Full Text
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<title>Federal Register, Volume 87 Issue 179 (Friday, September 16, 2022)</title>
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[Federal Register Volume 87, Number 179 (Friday, September 16, 2022)]
[Rules and Regulations]
[Pages 56895-56898]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-20041]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2018-0522; FRL-10130-01-OCSPP]
Eugenol; Exemption From the Requirement of a Tolerance
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 eugenol (2-methoxy-4-(-2-
propenyl)phenol) in or on all food commodities when used in accordance
with good agricultural practices. SciReg, Inc., on behalf of Eden
Research PLC, 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 eugenol when used in
accordance with this exemption.
DATES: This regulation is effective September 16, 2022. Objections and
requests for hearings must be received on or before November 15, 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-2018-0522, 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 the OPP Docket is (202) 566-1744. For the latest
status information on EPA/DC services, docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (703) 305-7090; email address:
<a href="/cdn-cgi/l/email-protection#561406061210041839223f3533251633263778313920"><span class="__cf_email__" data-cfemail="cc8e9c9c888a9e82a3b8a5afa9bf8ca9bcade2aba3ba">[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).
[[Page 56896]]
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
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. How 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-2018-0522 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
November 15, 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-2018-0522, 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">https://www.epa.gov/dockets</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. Background and Statutory Findings
In the Federal Register of August 24, 2018 (83 FR 42818) (FRL-9982-
37), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP8F8681) by Eden Research PLC, 6 Priory Ct., Priory Court
Business Park, Poulton, Cirencester, GL7 5JB, United Kingdom (c/o
SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192). The
petition requested that 40 CFR part 180 be amended by establishing an
exemption from the requirement of a tolerance for residues of eugenol
(2-methoxy-4-(-2-propenyl)phenol) in or on raw agricultural commodities
and processed foods when used in accordance with good agricultural
practices. That document referenced a summary of the petition prepared
by the petitioner Eden Research plc, c/o SciReg Inc., which is
available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no
substantive comments received in response to the notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.'' Additionally, FFDCA section 408(b)(2)(D) requires that 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 establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm to human health. 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 pesticide chemical residue, an exemption from the
requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for, including exposure resulting
from the exemption established by this action. EPA's assessment of
exposures and risks associated with eugenol follows.
IV. Toxicological Profile
Eugenol is a naturally occurring allyl chain-substituted guaiacol
and a member of the phenylpropanoid class of chemicals. Eugenol is also
the main constituent of clove bud oil (80 to 90%) and clove leaf oil
(82 to 88%), and is also found in cinnamon bark and leaves, Tulsi
leaves, turmeric, pepper, ginger, oregano and thyme and various other
herbs. As such, eugenol has long been part of the normal human diet. It
is currently approved by the U.S. Food and Drug Administration (FDA)
for use as a food additive and generally recognized as safe (GRAS) by
the FDA (21 CFR 184.1257).
In conducting its hazard assessment for eugenol, EPA relied on data
from the open scientific literature which includes (1) a 19-week
dietary study in rates, (2) a 13-week dietary study in rates, (3) five
prenatal developmental toxicity studies, and (4) several mutagenicity
studies. In these data, no adverse effects were seen at the highest
dose test of 300 mg/kg/day. For guideline studies, EPA generally
recommends testing at a limit dose of 1000 mg/kg/day. However, based on
the data reviewed from the open literature along with a body of
knowledge regarding eugenol such as its low toxicity; rapid degradation
into the environment; natural occurrence and widespread use in herbs
and a part of the human diet; EPA would not expect to see adverse
effects at higher doses.
With regard to the overall toxicological profile of eugenol, the
active ingredient is of minimal toxicity. Where data was not available
on eugenol for acute inhalation and primary eye irritation toxicity, it
was provided on isoeugenol. Isoeugenol is structurally and
physiochemically
[[Page 56897]]
similar to eugenol. Based on data provided for eugenol and isoeugenol,
eugenol is of low acute oral toxicity (Toxicity Category III) and
inhalation toxicity (Toxicity Category III). The active ingredient
shows moderate dermal toxicity (Toxicity Category II). It is a mild eye
(Toxicity Category III), a severe dermal irritant (Toxicity Category
II), and a weak dermal sensitizer.
With regard to subchronic toxicity, developmental toxicity,
reproductive toxicity and mutagenicity data requirements for the active
ingredient eugenol, all data requirements were satisfied by a
combination of guideline and non-guideline studies, data waivers, and
citations to studies from the Agency database as well as to the open
literature. For the 90-day oral data requirement, data was provided on
isoeugenol. There were no adverse subchronic effects for any oral or
dermal routes of exposure. Regarding subchronic dermal and subchronic
inhalation, EPA granted waivers for these data requirements based on
weight of evidence approach (WOE). Specific to subchronic dermal,
eugenol is the main constituent of clove bud oil and clove leaf oil. It
is used extensively in dentistry for its analgesic and anti-
inflammatory activities. In addition, the dermal margin of exposure
(MOE) is based on a 300 mg/kg/day point of departure (POD) range from
460-33,000. This is well above the Agency's Level of Concern (LOC) of
100.
In terms of subchronic inhalation toxicity, eugenol has low
inhalation toxicity. Eugenol is used in spray perfumes up to a
concentration of 10%, in air fresheners up to 5%, and oil of clove in
massage products and perfumes up to 30%. Despite its broad usage in
cosmetics and air fresheners, no or few adverse incidents have been
reported. Lastly, the occupational handler inhalation MOEs are more
than ten times the LOC of 100, ranging from 550,000 to 12,000,000.
In terms of mutagenicity, the active ingredient was determined to
be non-mutagenic, and no adverse effects were identified relative to
either developmental toxicity or reproductive toxicity.
In conclusion, there were no adverse subchronic effects for any
oral, dermal, inhalation, or developmental routes of exposure and as
stated previously, EPA has granted a waiver of these data requirements
based on a WOE approach for the subchronic toxicity testing considering
all the available eugenol hazard and exposure data. This WOE approach
includes the following rationale:
1. Exposure from all routes and in all scenarios is considered to
be negligible due to the following reasons: (1) eugenol is moderately
volatile with a vapor pressure of 2.7 Pa @25oC; volatilization from
both moist and dry soil surfaces is expected due to thymol's Henry's
Law Constant of 1.92 x 10-6 atm-cu m/mol and vapor pressure; eugenol is
expected to exist solely as a vapor in the ambient atmosphere, which
would be readily degraded in the atmosphere by reaction with
photochemically-produced hydroxyl radicals; the half-life for this
reaction in the air is estimated to be 5.9 hours; vapor phase eugenol
is also degraded in the atmosphere by reaction with ozone, the half-
life for this reaction is estimated to be 23 hours; Eugenol also
absorbs UV light and therefore is likely susceptible to direct
photolysis by sunlight; and (2) eugenol is expected to readily
biodegrade as demonstrated in guideline ready biodegradability studies.
2. Eugenol is naturally occurring and has long been part of the
normal human diet. It is currently FDA-approved for use as a food
additive (21 CFR 175.105). FDA also considers eugenol as GRAS (21 CFR
184.1257). Eugenol is commonly used in foods, air fresheners,
cosmetics, and perfumes.
3. Eugenol demonstrates low toxicity throughout its toxicity
database. No adverse effects were observed to highest dose tested (300
mg/kg/day) (exception is one eugenol study with no-observed-adverse-
effect level (NOAEL) of 300 mg/kg/day and lowest-observed-adverse-
effect-level (LOAEL) of 625 mg/kg/day based on decreased body weight)
in the eugenol toxicity database. The database includes a 19-week
dietary study in rats, a 13-week dietary study in rats, five prenatal
developmental toxicity studies, and several genotoxicity studies. Data
from the open literature indicates that eugenol is rapidly metabolized
as well as rapidly excreted.
A. Toxicological Points of Departure/Levels of Concern
Based on the toxicological profile, EPA did not identify any
toxicological endpoints of concern for eugenol.
B. Exposure Assessment
1. Dietary exposure from food, feed uses, and drinking water.
Eugenol is naturally occurring and has long been part of the normal
human diet. As part of its qualitative risk assessment for eugenol, the
Agency considered the potential for any additional dietary exposure to
residues of eugenol from its proposed use as a fungicide and nematicide
on agricultural use sites. EPA expects dietary (food and drinking
water) exposures from the proposed use of eugenol to be negligible due
to its short half-life and biodegradable nature. A quantitative dietary
exposure assessment was not conducted since a toxicological endpoint
for risk assessment was not identified.
2. Residential exposure. The term ``residential exposure'' is used
in this document to refer to non-occupational, non-dietary exposure.
Eugenol is not proposed to be registered for any pesticidal uses that
would result in residential exposure. Residential exposure may occur
from non-pesticidal uses such as air fresheners, cosmetics, and
perfumes. However, a quantitative residential exposure assessment was
not conducted since a toxicological endpoint for risk assessment was
not identified.
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 a tolerance 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 found that eugenol shares a
common mechanism of toxicity with any other substances, and eugenol
does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed eugenol does not have 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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
C. Safety Factor for Infants and Children
FFDCA Section 408(b)(2)(C) provides that EPA shall retain an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the Food Quality Protection Act
(FQPA) safety factor. In applying this provision, EPA either retains
the default value of 10X, or uses a different additional safety factor
when reliable data available to EPA support the choice of a different
factor. The Agency has determined that
[[Page 56898]]
a qualitative risk assessment rather than a quantitative risk
assessment would be most appropriate for the proposed use based on the
toxicity profiles of eugenol along with its long history of human
exposure. For this reason, a FQPA safety factor is not required at this
time. EPA has concluded there are no toxicological endpoints of concern
for the U.S. population, including infants and children.
D. Aggregate Risks
Based on the available data and information, EPA has concluded that
a qualitative aggregate risk assessment is appropriate to support this
action, and that risks of concern are not anticipated from aggregate
exposure to eugenol. This conclusion is based on the low toxicity of
eugenol, long history of human exposure to eugenol via the normal human
diet and expected rapid degradation of eugenol in the environment.
A full explanation of the data upon which EPA relied and its risk
assessment based on those data can be found in the December 15, 2021,
document entitled ``Risk Assessment for FIFRA Section 3 Registrations
of Eugenol Technical Containing 99.62% Eugenol as an Active Ingredient,
Mevalone, Containing 3.21% Eugenol as an Active Ingredient. Tolerance
Exemption Petition for Eugenol''. This document, as well as other
relevant information, is available in the docket for this action as
described under ADDRESSES.
V. Determination of Safety for U.S. Population, Infants and Children
Based on the Agency's assessment, EPA concludes that there is
reasonable certainty that no harm will result to the U.S. population,
including infants and children, from aggregate exposure to residues of
eugenol. Therefore, the establishment of an exemption from the
requirement of a tolerance for residues of eugenol (2-methoxy-4-(-2-
propenyl)phenol) in or on all food commodities when used in accordance
with good agricultural practices is safe under FFDCA section 408.
VI. Other Considerations
Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
VII. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established for residues of eugenol (2-methoxy-4-(-2-propenyl)phenol)
in or on all food commodities when used in accordance with good
agricultural practices.
VIII. 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).
IX. 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: September 12, 2022.
Edward Messina,
Director, 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. Add Sec. 180.1395 to subpart D to read as follows:
Sec. 180.1395 Eugenol; exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
eugenol (2-methoxy-4-(-2-propenyl)phenol) in or on all food commodities
when used in accordance with good agricultural practices.
[FR Doc. 2022-20041 Filed 9-15-22; 8:45 am]
BILLING CODE 6560-50-P
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