Proposed Rule2024-20078
Pesticide Tolerances; Implementing Registration Review Decisions for Certain Pesticides (Capric (Decanoic) Acid, Caprylic (Octanoic) Acid, and Pelargonic (Nonanoic) Acid)
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 6, 2024
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or Agency) is proposing to implement several tolerance actions under the Federal Food, Drug, and Cosmetic Act (FFDCA) that the Agency determined were necessary or appropriate during the registration review conducted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). During registration review, EPA reviews all aspects of a pesticide case, including existing tolerances, to ensure that the pesticide continues to meet the standard for registration under FIFRA. The pesticide tolerances and active ingredients addressed in this rulemaking are identified and discussed in detail in Unit III. of this document.
Full Text
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<title>Federal Register, Volume 89 Issue 173 (Friday, September 6, 2024)</title>
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[Federal Register Volume 89, Number 173 (Friday, September 6, 2024)]
[Proposed Rules]
[Pages 72775-72780]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-20078]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0454; FRL-12177-01-OCSPP]
RIN 2070-ZA16
Pesticide Tolerances; Implementing Registration Review Decisions
for Certain Pesticides (Capric (Decanoic) Acid, Caprylic (Octanoic)
Acid, and Pelargonic (Nonanoic) Acid)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The Environmental Protection Agency (EPA or Agency) is
proposing to implement several tolerance actions under the Federal
Food, Drug, and Cosmetic Act (FFDCA) that the Agency determined were
necessary or appropriate during the registration review conducted under
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). During
registration review, EPA reviews all aspects of a pesticide case,
including existing tolerances, to ensure that the pesticide continues
to meet the standard for registration under FIFRA. The pesticide
tolerances and active ingredients addressed in this rulemaking are
identified and discussed in detail in Unit III. of this document.
DATES: Comments must be received on or before November 5, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2023-0454, through <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 Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. 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>.
FOR FURTHER INFORMATION CONTACT: Anita Pease, Antimicrobials Division
(7510M), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 566-0736; email address: <a href="/cdn-cgi/l/email-protection#2050454153450e414e495441604550410e474f56"><span class="__cf_email__" data-cfemail="becedbdfcddb90dfd0d7cadffedbcedf90d9d1c8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural
[[Page 72776]]
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 might apply to them:
<bullet> Restaurant kitchen cleaning service (NAICS code 561720);
<bullet> Milk production, dairy cattle (NAICS code 112120);
<bullet> Food manufacturing (NAICS code 311);
<bullet> Pesticide manufacturing (NAICS code 32532); and
<bullet> Food processing machinery and equipment merchant
wholesalers (NAICS code 423830).
If you have any questions regarding the applicability of this
proposed action to a particular entity, consult the person listed under
FOR FURTHER INFORMATION CONTACT.
B. What action is the Agency taking?
EPA is proposing several tolerance actions that the Agency
previously determined were necessary or appropriate during registration
review for the pesticide active ingredients identified in Unit III. The
tolerance actions for each pesticide active ingredient are described in
Unit III. and may include but are not limited to the following types of
actions:
<bullet> Revising tolerance expressions;
<bullet> Modifying commodity definitions;
<bullet> Updating crop groupings;
<bullet> Removing expired tolerances;
<bullet> Revoking tolerances that are no longer needed; and
<bullet> Harmonizing tolerances with the Codex Alimentarius
Commission (Codex) Maximum Residue Levels (MRLs).
Although it may not have been identified in the registration review
of a particular pesticide, this rule may include proposals to reflect
the Agency's 2019 adoption of the Organization of Economic Cooperation
and Development (OECD) Rounding Class Practice. Where applicable, these
adjustments are proposed for specific pesticides as reflected in the
proposed regulatory text.
C. What is EPA's authority for taking this action?
Pursuant to section 408(e) of the Federal Food, Drug and Cosmetic
Act (FFDCA), 21 U.S.C. 346a(e), EPA is proposing the tolerance actions
in this rulemaking that the Agency previously determined were necessary
or appropriate during the registration review conducted under FIFRA, 7
U.S.C. 136 et seq. FFDCA section 408(e) authorizes EPA to establish,
modify, or revoke tolerances or exemptions from the requirement of a
tolerance on its own initiative. Prior to issuing the final regulation,
FFDCA section 408(e)(2) requires EPA to issue a notice of proposed
rulemaking for a 60-day public comment period, unless the Administrator
for good cause finds that it would be in the public interest to have a
shorter period and states the reasons in the rulemaking.
D. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit CBI to EPA through email or
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. If you wish to include CBI in your
comment, please follow the applicable instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly mark the
information that you claim to be CBI. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.
E. What can I do if I want the Agency to maintain a tolerance that the
Agency proposes to revoke?
This proposed rule provides a 60-day public comment period that
allows any person to state an interest in retaining a tolerance
proposed for revocation. If EPA receives such a comment within the 60-
day period, EPA will not proceed to revoke the tolerance immediately.
However, EPA will take steps to ensure the submission of any needed
supporting data and will issue an order in the Federal Register under
FFDCA section 408(f), if needed. The order would specify data needed
and the timeframes for submission of the data and would require that
within 90 days, some person or persons, notify EPA that they will
submit the data. If the data are not submitted as required in the
order, EPA will take appropriate action under FFDCA.
After considering comments that are received in response to this
proposed rule, EPA will issue a final rule. At the time of the final
rule, you may file an objection or request a hearing on the action
taken in the final rule. If you fail to file an objection to the final
rule within the time period specified in the final rule, you will have
waived the right to raise any issues resolved in the final rule. After
the filing deadline specified in the final rule, issues resolved in the
final rule cannot be raised again in any subsequent proceedings.
II. Background
A. What is a tolerance?
A ``tolerance'' represents the maximum level for residues of a
pesticide chemical legally allowed in or on food, which includes raw
agricultural commodities and processed foods and feed for animals.
Under the FFDCA, residues of a pesticide chemical that are not covered
by a tolerance or exemption from the requirement of a tolerance are
considered unsafe. See 21 U.S.C. 346a(a)(1). Foods containing unsafe
residues are deemed adulterated and may not be distributed in
interstate commerce. See 21 U.S.C. 331(a) and 342(a)(2)(B).
Consequently, for a food-use pesticide (i.e., a pesticide use that is
likely to result in residues in or on food) to be sold and distributed,
the pesticide must not only have appropriate tolerances or exemptions
under the FFDCA, but also must be registered under FIFRA. Food-use
pesticides not registered in the United States must have tolerances or
exemptions in order for commodities treated with those pesticides to be
imported into the United States. For additional information about
tolerances, go to <a href="https://www.epa.gov/pesticide-tolerances/about-pesticide-tolerances">https://www.epa.gov/pesticide-tolerances/about-pesticide-tolerances</a>.
B. Why does EPA consider international residue limits?
When establishing a tolerance for residues of a pesticide, EPA must
determine whether Codex has established a MRL for that pesticide. See
21 U.S.C. 346a(b)(4). Additionally, as part of the registration review
of a pesticide (see Unit II.C.), EPA determines whether international
MRLs exist for commodities and chemicals for which U.S. tolerances have
been established. Where appropriate, EPA's
[[Page 72777]]
intention is to harmonize U.S. tolerances with those international MRLs
to facilitate trade. EPA's effort to harmonize with international MRLs
is summarized in the tolerance reassessment section of the individual
Human Health Draft Risk Assessments that support the pesticide
registration review.
C. What is registration review?
Under FIFRA section 3(g), 7 U.S.C. 136a(g), EPA is required to
periodically review all registered pesticides and determine if those
pesticides continue to meet the standard for registration under FIFRA.
See also 40 CFR 155.40(a). The registration review program is intended
to make sure that, as the ability to assess risk evolves and as
policies and practices change, all registered pesticides can continue
to be used without causing unreasonable adverse effects on human health
and the environment. As part of the registration review of a pesticide,
EPA also evaluates whether existing tolerances are safe, whether any
changes to existing tolerances are necessary or appropriate, and
whether any new tolerances are necessary to cover residues from
registered pesticides. In addition, any tolerance changes identified as
necessary or appropriate during registration review of a pesticide are
summarized in the registration review decision documents for each
pesticide active ingredient or registration review case (e.g., in the
Proposed Interim Decision (PID), Proposed Final Decision (PFD), Interim
Decision (ID) and Final Decision (FD)). These documents can be found in
the public docket that has been opened for each pesticide, which is
available online at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, using the docket ID
number listed in Unit III. for each pesticide active ingredient
included in this proposed action. Additional information about
pesticide registration review is available at <a href="https://www.epa.gov/pesticide-reevaluation">https://www.epa.gov/pesticide-reevaluation</a>.
D. What are ``Safety Findings''?
EPA has assessed the individual risks from exposure to the
pesticide active ingredients identified and discussed in Unit III.,
taking into consideration all reliable data on toxicity and exposure,
including for infants and children, and has included a safety finding
under FFDCA section 408(b) for the proposed tolerance actions. Based on
the supporting risk assessments and registration review documents,
which demonstrate that the aggregate exposure for each individual
chemical is below the Agency's level of concern, EPA concludes there is
a reasonable certainty that no harm will result to the general
population, or specifically to infants and children, from aggregate
exposure to residues of the pesticide active ingredients identified and
discussed in Unit III. Thus, EPA has determined that the proposed
tolerances for residues of the pesticide active ingredients identified
and discussed in Unit III. are safe.
Adequate enforcement methodology as described in the supporting
documents is available to enforce the tolerance expressions. Chemical
specific safety findings are discussed in detail in the human health
risk assessments conducted to support the registration review of each
specific pesticide active ingredient or registration review case. The
human health risk assessments can be found in the public docket that
has been opened for each pesticide, which is available online at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> using the docket ID number listed in Unit
III.
E. How does EPA's policy on children's health apply to tolerance
actions?
EPA's Policy on Children's Health (October 5, 2021) requires EPA to
protect children from environmental exposures by consistently and
explicitly considering early life exposures (from conception, infancy,
early childhood and through adolescence until 21 years of age) and
lifelong health in all human health decisions through identifying and
integrating children's health data and information when conducting risk
assessments. <a href="https://www.epa.gov/system/files/documents/2021-10/2021-policy-on-childrens-health.pdf">https://www.epa.gov/system/files/documents/2021-10/2021-policy-on-childrens-health.pdf</a>.
FFDCA section 408(b)(2)(C) requires 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 . .
.'' (FFDCA 408(b)(2)(C)). Consistent with FFDCA section 408(b)(2)(D),
and the factors specified therein, EPA has reviewed the available
scientific data and other relevant information in support of these
proposed tolerance actions. The Agency's consideration is documented in
the pesticide specific registration review decision documents. See the
pesticide specific discussions in Unit III. and the chemical specific
registration review documents that are available in the pesticide
specific docket as identified in Unit III.
III. Proposed Tolerance Actions
EPA is proposing to take the specific tolerance actions identified
in this unit and as described in the March 2022 Combined PWP/PID.
Capric (decanoic) acid, caprylic (octanoic) acid, and pelargonic
(nonanoic) acid are registered for antimicrobial use as a sanitizer on
food processing and dairy equipment. As a result of those uses,
residues of these chemicals may be found in food that come into contact
with treated surfaces; thus, that use is categorized as an ``indirect
food use'' that requires a tolerance or exemption. Absent information
supporting a conclusion that no residues would be available for
transfer to food, a tolerance or tolerance exemption is required for
capric (decanoic) acid, caprylic (octanoic) acid, and pelargonic
(nonanoic) acid.
However, the Agency is now proposing to amend these established
tolerance exemptions because they include outdated application rate
limits. Because the latest evaluations of these pesticides determined
that there are no dietary risks of concern, the application rate limits
on the tolerance exemptions are no longer necessary. Additionally, the
Agency is proposing to remove several duplicative tolerance exemptions
that were not initially identified in the combined PWP/PID but are
justified by the same science rationale as described in the combined
PWP/PID.
A. 40 CFR 180.940; Capric (Decanoic) Acid
As noted in the March 2022 PWP/PID, there are exemptions from the
requirement of a tolerance under 40 CFR 180.940 (b) and (c) for
residues of capric (decanoic) acid when applied to dairy-processing
equipment and food processing equipment and utensils, with the
limitation that the end-use concentration of capric (decanoic) acid
does not exceed 90 ppm (section b), and 234 ppm (section c). After the
issuance of the PWP/PID, it was found that an exemption from the
requirement of a tolerance for capric (decanoic acid) exists in section
(a) as well with the limitation that the end-use concentration of
caprylic (octanoic) acid is not to exceed 100 ppm. EPA, on its own
initiative is therefore proposing to remove the redundant exemptions
and limits for capric (decanoic) acid under 40 CFR 180.940 (b) and (c)
entirely, and to remove the 100 ppm limit for capric (decanoic) acid
from 180.940(a). As discussed in Unit II.D., EPA concludes there is a
reasonable certainty that no harm will result to the general
[[Page 72778]]
population, or specifically to infants and children, from aggregate
exposure to capric (decanoic acid) residues. The proposed tolerance
changes are considered safe and adequate enforcement methodology is
available.
B. 40 CFR 180.940; Caprylic (Octanoic) Acid
As noted in the March 2022 PWP/PID, there are exemptions from the
requirement of a tolerance under 40 CFR 180.940 (b), and (c) for
residues of caprylic (octanoic) acid when applied to dairy-processing
equipment and food processing equipment and utensils, with the
limitation that the end-use concentration of caprylic (octanoic) acid
does not exceed 176 ppm (section b), and 234 ppm (section c). After the
issuance of the PWP/PID, it was found that two exemptions from the
requirement of a tolerance for caprylic (octanoic acid) exist in
section (a) as well with limitations that the end-use concentration of
caprylic (octanoic) acid is not to exceed 52 ppm and 100 ppm. EPA, on
its own initiative is therefore proposing to remove the redundant
exemptions and limits for caprylic (octanoic) acid from 40 CFR 180.940
(b) and (c) entirely, and to remove the 100 ppm limits for caprylic
(octanoic) acid from 180.940(a). As discussed in Unit II.D., EPA
concludes there is a reasonable certainty that no harm will result to
the general population, or specifically to infants and children, from
aggregate exposure to caprylic (octanoic) acid residues. The proposed
tolerance changes are considered safe and adequate enforcement
methodology is available.
C. 40 CFR 180.940; Pelargonic (Nonanoic) Acid
As noted in the March 2022 PWP/PID, there are exemptions from the
requirement of a tolerance under 40 CFR 180.940(a), (b), and (c) for
residues of pelargonic (nonanoic) acid when applied to dairy-processing
equipment and food processing equipment and utensils, with the
limitation that the end-use concentration of pelargonic (nonanoic) acid
does not exceed 100 ppm (section a) and 90 ppm (sections b and c). EPA,
on its own initiative is therefore proposing to remove the redundant
exemptions and limits for pelargonic (nonanoic) acid from 40 CFR
180.940 (b) and (c) entirely, and to remove the 100 ppm limit for
pelargonic (nonanoic) acid from 180.940(a). As discussed in Unit II.D.,
EPA concludes there is a reasonable certainty that no harm will result
to the general population, or specifically to infants and children,
from aggregate exposure to pelargonic (nonanoic) acid residues. The
proposed tolerance changes are considered safe and adequate enforcement
methodology is available.
D. 40 CFR 180.1159(c); Pelargonic (Nonanoic Acid)
Also outlined in the March 2022 PWP/PID, there is an exemption from
the requirement of a tolerance for residues of pelargonic (nonanoic)
acid in or on all raw agricultural commodities and in processed
commodities, when such residues result from the use of pelargonic
(nonanoic) acid as an antimicrobial treatment in solutions containing a
diluted end-use concentration of pelargonic (nonanoic) acid on food
contact surfaces such as equipment, pipelines, tanks, vats, fillers,
evaporators, pasteurizers and aseptic equipment in restaurants, food
service operations, dairies, breweries, wineries, beverage and food
processing plants, with a limitation of 170 ppm. EPA, on its own
initiative, is therefore proposing to remove the limit of 170 ppm under
40 CFR 180.1159(c) for pelargonic (nonanoic) acid. As discussed in Unit
II.D., EPA concludes there is a reasonable certainty that no harm will
result to the general population, or specifically to infants and
children, from aggregate exposure to pelargonic (nonanoic) acid
residues. The proposed tolerance changes are considered safe and
adequate enforcement methodology is available.
E. 40 CFR 180.1225; Capric (Decanoic) Acid
As outlined in the March 2022 PWP/PID, there is an exemption from
the requirement of a tolerance for residues of capric (decanoic) acid
in or on all raw agricultural commodities and in processed commodities,
when such residues result from the use of capric (decanoic) acid as an
antimicrobial treatment in solutions containing a diluted end-use
concentration of capric (decanoic) acid on food contact surfaces such
as equipment, pipelines, tanks, vats, fillers, evaporators,
pasteurizers, and aseptic equipment in restaurants, food service
operations, dairies, breweries, wineries, beverage and food processing
plants, with the limitation of 170 ppm. EPA, on its own initiative, is
therefore proposing to remove the limit of 170 ppm under 40 CFR
180.1225 for capric (decanoic) acid. As discussed in Unit II.D., EPA
concludes there is a reasonable certainty that no harm will result to
the general population, or specifically to infants and children, from
aggregate exposure to capric (decanoic) acid residues. The proposed
tolerance changes are considered safe and adequate enforcement
methodology is available.
IV. Proposed Effective and Expiration Date(s)
EPA is proposing that these tolerance actions would be effective on
the date of publication of the final rule in the Federal Register.
However, for actions in the final rule that lower or revoke existing
tolerances, EPA is proposing an expiration date for the existing
tolerance of six months after the date of publication of the final rule
in the Federal Register, to allow a reasonable interval for producers
in exporting members of the World Trade Organization's (WTO's) Sanitary
and Phytosanitary (SPS) Measures Agreement to adapt to the
requirements.
V. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at <a href="https://www.epa.gov/regulations/and-executive-orders">https://www.epa.gov/regulations/and-executive-orders</a>.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 14094: Modernizing Regulatory Review
This action is exempt from review under Executive Order 12866 (58
FR 51735, October 4, 1993), as amended by Executive Order 14094 (88 FR
21879, April 11, 2023), because it proposes to establish or modify a
pesticide tolerance or a tolerance exemption under FFDCA section 408.
This exemption also applies to tolerance revocations for which
extraordinary circumstances do not exist. As such, this exemption
applies to the tolerance revocations in this proposed rule because the
Agency knows of no extraordinary circumstances that warrant
reconsideration of this exemption for those proposed tolerance
revocations.
B. Paperwork Reduction Act (PRA)
This action does not impose an information collection burden under
the PRA 44 U.S.C. 3501 et seq., because it does not contain any
information collection activities.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. In making this determination, EPA concludes that the
impact of concern for this action is any significant adverse economic
impact on small entities and that the Agency is certifying that this
action will not have a significant economic impact on a substantial
[[Page 72779]]
number of small entities because the action has no net burden on small
entities subject to this rulemaking. This determination takes into
account an EPA analysis for tolerance establishments and modifications
that published in the Federal Register of May 4, 1981 (46 FR 24950)
(FRL-1809-5), and for tolerance revocations on December 17, 1997 (62 FR
66020) (FRL-5753-1). Additionally, in a 2001 memorandum, EPA determined
that eight conditions must all be satisfied in order for an import
tolerance or tolerance exemption revocation to adversely affect a
significant number of small entity importers, and that there is a
negligible joint probability of all eight conditions holding
simultaneously with respect to any particular revocation. See
Memorandum from Denise Keehner, Division Director, Biological and
Economic Analysis Division, Office of Pesticide Programs, entitled
``RFA/SBREFA Certification for Import Tolerance Revocation'' and dated
May 25, 2001, which is available in docket ID No. EPA-HQ-OPP-2005-0322
at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
For the pesticides named in this rulemaking, EPA concludes that
there is no reasonable expectation that residues of the pesticides for
tolerances listed in this rulemaking for revocation will be found on
the commodities discussed in this rulemaking, and the Agency knows of
no extraordinary circumstances that exist as to the present proposed
rule that would change EPA's previous analyses.
Any comments about the Agency's determination for this rulemaking
should be submitted to EPA along with comments on the proposed rule and
will be addressed in the final rule.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more (in 1995 dollars and adjusted annually for inflation) as described
in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely
affect small governments. The action imposes no enforceable duty on any
state, local or tribal governments or the private sector.
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on tribal governments, on the
relationship between the Federal government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
government and Indian tribes.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it is not a significant regulatory action under
section 3(f)(1) of Executive Order 12866 (See Unit V.A.), and because
EPA does not believe the environmental health or safety risks addressed
by this action present a disproportionate risk to children. However,
EPA's 2021 Policy on Children's Health applies to this action as
discussed in Unit II.D. generally, and in Unit III. in the context of
the individual chemicals addressed in this action.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not subject to Executive Order 13211 (66 FR 28355)
(May 22, 2001) because it is not a significant regulatory action under
Executive Order 12866.
I. National Technology Transfer Advancement Act (NTTAA)
This action does not involve technical standards that would require
Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All
EPA believes that the human health and environmental conditions
that exist prior to this action do not result in disproportionate and
adverse effects on communities with EJ concerns as described in
Executive Orders 12898 (59 FR 7629, February 16, 1994), and 14096 (88
FR 25251, April 26, 2023). Furthermore, EPA believes that this action
is not likely to result in new disproportionate and adverse effects on
communities with environmental justice concerns. As discussed in more
detail in the pesticide specific risk assessments conducted as part of
the registration review for each pesticide identified in Unit III., EPA
has considered the safety risks for the pesticides subject to this
rulemaking and in the context of the tolerance actions set out in this
rulemaking. See also Unit I.D.3.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 28, 2024.
Edward Messina,
Director, Office of Pesticide Programs.
Therefore, the EPA proposes to amend 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. Amend Sec. 180.940 by:
0
a. In table 1 in paragraph (a):
0
i. Removing the entries for ``Decanoic acid''; Nonanoic acid''; and
``Octanoic acid'';
0
ii. Adding in alphabetical order the entries ``Capric (decanoic)
acid''; ``Caprylic (octanoic) acid''; and ``Pelargonic (nonanoic)
acid'';
0
b. In the table in paragraph (b) removing the entries for ``Decanoic
acid''; ``Nonanoic acid''; and ``Octanoic acid''; and
0
c. In the table in paragraph (c) removing the entries in paragraph (c)
for ``Decanoic acid''; ``Nonanoic acid''; and ``Octanoic acid''.
The additions read as follows:
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
* * * * *
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
CAS Reg.
Pesticide chemical No. Limits
------------------------------------------------------------------------
* * * * *
Capric (decanoic) acid.................. 334-48-5 None.
Caprylic (octanoic) acid................ 124-07-2 None.
* * * * *
Pelargonic (nonanoic) acid.............. 112-05-0 None.
* * * * *
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[[Page 72780]]
* * * * *
0
3. Amend Sec. 180.1159 by revising the section heading and revising
and republishing paragraph (c) to read as follows:
Sec. 180.1159 Pelargonic (nonanoic) acid; exemption from the
requirement of tolerances.
* * * * *
(c) An exemption from the requirement of a tolerance is established
for residues of pelargonic (nonanoic) acid in or on all raw
agricultural commodities and in processed commodities, when such
residues result from the use of pelargonic (nonanoic) acid as an
antimicrobial treatment for application on food contact surfaces such
as equipment, pipelines, tanks, vats, fillers, evaporators,
pasteurizers and aseptic equipment in restaurants, food service
operations, dairies, breweries, wineries, beverage and food processing
plants.
0
4. Revise and republish Sec. 180.1225 to read as follows:
Sec. 180.1225 Capric (decanoic) acid; exemption from the requirement
of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of capric (decanoic) acid in or on all raw agricultural
commodities and in processed commodities, when such residues result
from the use of capric (decanoic) acid as an antimicrobial treatment in
solutions containing a diluted end-use concentration of capric
(decanoic) acid on food contact surfaces such as equipment, pipelines,
tanks, vats, fillers, evaporators, pasteurizers and aseptic equipment
in restaurants, food service operations, dairies, breweries, wineries,
beverage and food processing plants.
[FR Doc. 2024-20078 Filed 9-5-24; 8:45 am]
BILLING CODE 6560-50-P
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</html>Indexed from Federal Register on September 6, 2024.
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