Tetraacetylethylenediamine (TAED), and Its Metabolite Diacetylethylenediamine (DAED); Exemption From the Requirement of a Pesticide Tolerance, 70103-70106 [2024-19448]
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Federal Register / Vol. 89, No. 168 / Thursday, August 29, 2024 / Rules and Regulations
Department of Homeland Security Delegation
No. 00170.1, Revision No. 01.3.
ENVIRONMENTAL PROTECTION
AGENCY
2. Add § 165.T01–0559 to read as
follows:
40 CFR Part 180
■
§ 165.T01–0559 Safety Zone; West
Passage Narragansett Bay, Jamestown, RI.
(a) Location. The following area is a
safety zone: All waters within a 250yard radius of the MARMAC 306 cable
laying barge and J.F. Brennan
construction barge #4132 while
operating in West Passage Narraganset
Bay, Jamestown, RI, between Jamestown
Verrazzano Bridge (41°31′43.7″ N
71°24′18.2″ W) and Dutch Island
(41°29′47.3″ N, 71°24′16.5″ W).
(b) Definitions. As used in this
section, Designated Representative
means a Coast Guard Patrol
Commander, including a Coast Guard
coxswain, petty officer, or other officer
operating a Coast Guard vessel and a
Federal, State, and local officer
designated by or assisting the Captain of
the Port Sector Southeastern New
England (COTP) in the enforcement of
the safety zone.
(c) Regulations. (1) Under the general
safety zone regulations in subpart C of
this part, you may not enter the safety
zone described in paragraph (a) of this
section unless authorized by the COTP
or the COTP’s designated representative.
(2) To seek permission to enter,
contact the COTP or the COTP’s
representative by VHF–FM radio
channel 16 or phone at 866–819–9128.
Those in the safety zone must comply
with all lawful orders or directions
given to them by the COTP or the
COTP’s designated representative.
(d) Enforcement period. This section
is effective from 12:01 a.m. on Sunday,
September 1, 2024, through 11:59 p.m.
on Tuesday, December 31, 2024. The
safety zone described in paragraph (a) of
this section will only be subject to
enforcement while the MARMAC 306
cable laying barge and J.F. Brennan
construction barge #4132 are engaged in
cable laying operations.
Y. Moon,
Captain, U.S. Coast Guard, Captain of the
Port Sector Southeastern New England.
[FR Doc. 2024–19576 Filed 8–28–24; 8:45 am]
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[EPA–HQ–OPP–2023–0208; FRL–12187–01–
OCSPP]
Tetraacetylethylenediamine (TAED),
and Its Metabolite
Diacetylethylenediamine (DAED);
Exemption From the Requirement of a
Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of
tetraacetylethylenediamine (TAED),
including its metabolites and
degradates, on or applied to food
contact surfaces in public eating places,
dairy processing equipment, and food
processing equipment and utensils. This
tolerance exemption is established on
the Agency’s own initiative under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), in order to implement the
tolerance actions EPA identified during
its review of this chemical as part of the
Agency’s registration review program
under the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA).
SUMMARY:
This regulation is effective
August 29, 2024. Objections and
requests for hearings must be received
on or before October 28, 2024 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–2023–0208, 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 the OPP
docket is (202) 566–1744. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Anita Pease, Antimicrobials Division
(7510M), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
DATES:
PO 00000
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70103
20460–0001; telephone number: (202)
566–0736; email address: pease.anita@
epa.gov or ADFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are a 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:
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
• Restaurant kitchen cleaning
services (NAICS code 561720).
• Milk production, dairy cattle
(NAICS code 112120).
• Food processing machinery and
equipment merchant wholesalers
(NAICS code 423830).
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. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, 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–2023–0208 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 in the Office of the
Administrative Law Judges on or before
October 28, 2024. Notwithstanding the
procedural requirements of 40 CFR
178.25(b), the Office of the
Administrative Law Judges has issued
an order urging parties to file and serve
documents with the Tribunal by
electronic means only. See Revised
Order Urging Electronic Filing and
Service (dated June 22, 2023), https://
www.epa.gov/system/files/documents/
2023-06/2023-06-22%20%20revised%20order%20
urging%20electronic%20filing%20and
%20service.pdf.
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Federal Register / Vol. 89, No. 168 / Thursday, August 29, 2024 / Rules and Regulations
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–
2023–0208, 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.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
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II. Background
A. Proposed Rule
In the Federal Register of March 8,
2024 (89 FR 16714) (FRL–11678–01–
OCSPP), EPA issued a document
pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing
of an Agency initiated exemption from
the requirement of a tolerance for TAED,
and its metabolites and degradates. The
action proposed that 40 CFR 180.940(a)
be amended by establishing an
exemption from the requirement of a
tolerance with no limit in end-use
solutions eligible for tolerance
exemption. The Agency had identified
the need for the exemption as part of the
registration review process under the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), 7 U.S.C.
136a(g), and published a proposed
rulemaking under its authority to
initiate tolerance rulemakings under the
FFDCA section 408(e), 21 U.S.C.
346a(e).
As noted in the proposal, the TAED
Interim Registration Review Decision
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(TAED ID), identified the need for this
exemption based on existing registered
pesticide uses, and the underlying risk
assessment concluded that there were
no risks of concern associated with
these uses. Electronic copies of the
TAED ID and other documents are
available in EPA docket number EPA–
HQ–OPP–2013–0608 at https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
B. What is the Agency’s authority for
taking this action?
Under section 408(e) of the FFDCA,
EPA can establish an exemption from
the requirement of a tolerance for
residues of a pesticide chemical after
publishing a proposed rule and
providing 60-day period for public
comment, 21 U.S.C. 346a(e). EPA
published the proposed rule on March
8, 2024, and provided 60 days for public
comment (until May 7, 2024).
III. Final Rule
A. Comments
No comments were submitted in
response to the proposed rule.
B. 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 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. . . .’’
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As noted in the proposed rule, EPA
reviewed the available scientific data
and other relevant information as part of
registration review and in support of
this action. Based on that review, EPA’s
proposed rule concluded that the
exemptions would be safe.
Since no comments were filed, EPA’s
assessment of the potential for risks
from exposure to these pesticide
chemicals and conclusions about the
safety of this exemption remains
unchanged. Therefore, based on the lack
of any aggregate risks of concern, EPA
concludes that this exemption from the
requirement of a tolerance for residues
of TAED, and its metabolites and
degradates, is safe, i.e., there is a
reasonable certainty that no harm will
result from aggregate exposures to
TAED, and its metabolites and
degradates, when used in accordance
with the terms of the respective
exemption. In addition, EPA has
determined that there is a reasonable
certainty that no harm will result to
infants and children from aggregate
exposure to the pesticide chemical
residues, in accordance with FFDCA
section 408(b)(2)(C).
IV. Conclusion
Therefore, an exemption from the
requirement of a tolerance is established
for residues of TAED, and its
metabolites and degradates, when used
on or applied to food contact surfaces in
public eating places, dairy processing
equipment, and food processing
equipment and utensils, with no
limitation.
V. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive orders can be
found at https://www.epa.gov/lawsregulations/laws-and-executiveorders#influence.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulations
and Regulatory Review
This action is exempt from review by
the Office of Management and Budget
(OMB) under Executive Orders 12866
(58 FR 51735, October 4, 1993), and
13563 (76 FR 3821, January 21, 2011)
because it establishes tolerance
exemptions under FFDCA section 408.
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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 rule is any significant adverse
economic impact on small entities and
that the Agency is certifying that this
rule will not have a significant
economic impact on a substantial
number of small entities because the
rule has no net burden on small entities
subject to the rule. As discussed in the
proposed rule, this takes into account
the EPA analysis for the establishment
and modification of tolerances.
Furthermore, the Agency did not receive
any comments on these conclusions as
presented in the proposed rule.
D. Unfunded Mandates Reform Act
(UMRA)
This action does not contain any
unfunded mandate 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, August 10, 1999 (64 FR
43255). 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.
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F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have Tribal
implications as specified in Executive
Order 13175, November 9, 2000 (65 FR
67249), 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.
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G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
Executive Order 13045 (62 FR 19885,
April 23, 1997) directs Federal agencies
to include an evaluation of health and
safety effects of the planned regulation
on children in Federal health and safety
standards and explain why the
regulation is preferable to potential
effective and reasonably feasible
alternatives. This action is also not
subject to Executive Order 13045,
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 Policy on Children’s
Health applies to this action.
This rule finalizes tolerance actions
under the FFDCA, which 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 and
other data and other relevant
information in support of these final
tolerance actions. The Agency’s
consideration is documented in the
pesticide specific registration review
decision documents. See the discussion
in Unit III. and access the chemical
specific registration review documents
in each chemical docket at https://
www.regulations.gov.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution or Use
This action is not a 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 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
Executive Order 12898 (59 FR 7629,
February 16, 1994) directs Federal
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70105
agencies, to the greatest extent
practicable and permitted by law, to
make environmental justice part of their
mission by identifying and addressing,
as appropriate, disproportionately high
and adverse human health or
environmental effects of their programs,
policies, and activities on minority
populations (people of color and/or
indigenous peoples) and low-income
populations. As discussed in more
detail in the pesticide specific risk
assessments conducted as part of the
registration review for the pesticides
identified in Unit II., 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. EPA
believes that the human health and
environmental conditions that exist
prior to this action do not result in
disproportionate and adverse effects on
people of color, low-income
populations, and/or indigenous peoples.
Furthermore, EPA believes that this
action is not likely to result in new
disproportionate and adverse effects on
people of color, low-income
populations, and/or indigenous peoples.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5
U.S.C. 801 et seq., and EPA will submit
a rule report to each House of the
Congress and to the Comptroller General
of the United States. 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: August 21, 2024.
Anita Pease,
Director, Antimicrobials 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
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.940, amend table 1 to
paragraph (a) by adding, in alphabetical
order, an entry for
‘‘Tetraacetylethylenediamine (TAED)’’
to read as follows:
■
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Federal Register / Vol. 89, No. 168 / Thursday, August 29, 2024 / Rules and Regulations
§ 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)
Pesticide chemical
CAS Reg. No.
*
*
*
*
*
Tetraacetylethylenediamine (TAED) ........................................................................................................
*
*
*
*
*
*
*
*
*
under the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA).
*
[FR Doc. 2024–19448 Filed 8–28–24; 8:45 am]
BILLING CODE 6560–50–P
This regulation is effective
August 29, 2024. Objections and
requests for hearings must be received
on or before October 28, 2024, 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–2023–0455, 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 for the OPP
Docket is (202) 566–1744. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Anita Pease, Antimicrobials Division
(7510M), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(202) 566–0736; email address:
pease.anita@epa.gov or ADFRNotices@
epa.gov.
DATES:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2023–0455; FRL–12194–01–
OCSPP]
Lactic Acid and L-Lactic Acid;
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation removes the
duplicative exemption from the
requirement of a tolerance for residues
of lactic acid and l-lactic acid, herein
referred to as l-lactic acid, when
applied/used in dairy processing
equipment and food processing
equipment and utensils. In addition, the
Agency is amending an existing
exemption from the requirement of a
tolerance for lactic acid to also include
l-lactic acid. The Agency is also
establishing exemptions from the
requirement of a tolerance for residues
of l-lactic acid when used as a fruit and
vegetable wash in or on all raw
agricultural commodities, and for
indirect or inadvertent residues of llactic acid in or on all livestock
commodities, when residues are present
therein as a result of animal drinking
water coming into contact with hard
non-porous surfaces treated with l-lactic
acid (i.e., troughs). These tolerance
exemptions are established on the
Agency’s own initiative under the
Federal, Food, Drug, and Cosmetic Act
(FFDCA), in order to implement the
tolerance actions EPA identified during
its review of this chemical as part of the
Agency’s registration review program
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SUMMARY:
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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
PO 00000
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*
10543–57–4
Sfmt 4700
*
Limits
*
None.
*
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:
• Food manufacturing (NAICS code
311),
• Pesticide manufacturing (NAICS
code 32532),
• Restaurant kitchen cleaning
services (NAICS code 561720),
• Milk production, dairy cattle
(NAICS code 112120),
• Food processing machinery and
equipment wholesalers (NAICS code
423830).
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. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, 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–2023–0455 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
October 28, 2024. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b). Notwithstanding the
procedural requirements of 40 CFR
178.25(b), the Office of the
Administrative Law Judges has issued
an order urging parties to file and serve
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]]>Agencies
[Federal Register Volume 89, Number 168 (Thursday, August 29, 2024)]
[Rules and Regulations]
[Pages 70103-70106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19448]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0208; FRL-12187-01-OCSPP]
Tetraacetylethylenediamine (TAED), and Its Metabolite
Diacetylethylenediamine (DAED); Exemption From the Requirement of a
Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of tetraacetylethylenediamine (TAED),
including its metabolites and degradates, on or applied to food contact
surfaces in public eating places, dairy processing equipment, and food
processing equipment and utensils. This tolerance exemption is
established on the Agency's own initiative under the Federal Food,
Drug, and Cosmetic Act (FFDCA), in order to implement the tolerance
actions EPA identified during its review of this chemical as part of
the Agency's registration review program under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA).
DATES: This regulation is effective August 29, 2024. Objections and
requests for hearings must be received on or before October 28, 2024
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-2023-0208, 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 the OPP docket is (202) 566-1744. Please review the
visitor instructions and additional information about the docket
available at https://www.epa.gov/dockets.
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: [email protected] or
[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 a
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:
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
Restaurant kitchen cleaning services (NAICS code 561720).
Milk production, dairy cattle (NAICS code 112120).
Food processing machinery and equipment merchant
wholesalers (NAICS code 423830).
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. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2023-0208 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 in the Office
of the Administrative Law Judges on or before October 28, 2024.
Notwithstanding the procedural requirements of 40 CFR 178.25(b), the
Office of the Administrative Law Judges has issued an order urging
parties to file and serve documents with the Tribunal by electronic
means only. See Revised Order Urging Electronic Filing and Service
(dated June 22, 2023), https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf.
[[Page 70104]]
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-2023-0208, 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.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Background
A. Proposed Rule
In the Federal Register of March 8, 2024 (89 FR 16714) (FRL-11678-
01-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of an Agency initiated
exemption from the requirement of a tolerance for TAED, and its
metabolites and degradates. The action proposed that 40 CFR 180.940(a)
be amended by establishing an exemption from the requirement of a
tolerance with no limit in end-use solutions eligible for tolerance
exemption. The Agency had identified the need for the exemption as part
of the registration review process under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136a(g), and published
a proposed rulemaking under its authority to initiate tolerance
rulemakings under the FFDCA section 408(e), 21 U.S.C. 346a(e).
As noted in the proposal, the TAED Interim Registration Review
Decision (TAED ID), identified the need for this exemption based on
existing registered pesticide uses, and the underlying risk assessment
concluded that there were no risks of concern associated with these
uses. Electronic copies of the TAED ID and other documents are
available in EPA docket number EPA-HQ-OPP-2013-0608 at https://www.regulations.gov. There were no comments received in response to the
notice of filing.
B. What is the Agency's authority for taking this action?
Under section 408(e) of the FFDCA, EPA can establish an exemption
from the requirement of a tolerance for residues of a pesticide
chemical after publishing a proposed rule and providing 60-day period
for public comment, 21 U.S.C. 346a(e). EPA published the proposed rule
on March 8, 2024, and provided 60 days for public comment (until May 7,
2024).
III. Final Rule
A. Comments
No comments were submitted in response to the proposed rule.
B. 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 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. . .
.''
As noted in the proposed rule, EPA reviewed the available
scientific data and other relevant information as part of registration
review and in support of this action. Based on that review, EPA's
proposed rule concluded that the exemptions would be safe.
Since no comments were filed, EPA's assessment of the potential for
risks from exposure to these pesticide chemicals and conclusions about
the safety of this exemption remains unchanged. Therefore, based on the
lack of any aggregate risks of concern, EPA concludes that this
exemption from the requirement of a tolerance for residues of TAED, and
its metabolites and degradates, is safe, i.e., there is a reasonable
certainty that no harm will result from aggregate exposures to TAED,
and its metabolites and degradates, when used in accordance with the
terms of the respective exemption. In addition, EPA has determined that
there is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residues, in
accordance with FFDCA section 408(b)(2)(C).
IV. Conclusion
Therefore, an exemption from the requirement of a tolerance is
established for residues of TAED, and its metabolites and degradates,
when used on or applied to food contact surfaces in public eating
places, dairy processing equipment, and food processing equipment and
utensils, with no limitation.
V. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders#influence.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
This action is exempt from review by the Office of Management and
Budget (OMB) under Executive Orders 12866 (58 FR 51735, October 4,
1993), and 13563 (76 FR 3821, January 21, 2011) because it establishes
tolerance exemptions under FFDCA section 408.
[[Page 70105]]
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 rule is any significant adverse economic
impact on small entities and that the Agency is certifying that this
rule will not have a significant economic impact on a substantial
number of small entities because the rule has no net burden on small
entities subject to the rule. As discussed in the proposed rule, this
takes into account the EPA analysis for the establishment and
modification of tolerances. Furthermore, the Agency did not receive any
comments on these conclusions as presented in the proposed rule.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain any unfunded mandate 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, August 10, 1999 (64 FR 43255). 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, November 9, 2000 (65 FR 67249), 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
Executive Order 13045 (62 FR 19885, April 23, 1997) directs Federal
agencies to include an evaluation of health and safety effects of the
planned regulation on children in Federal health and safety standards
and explain why the regulation is preferable to potential effective and
reasonably feasible alternatives. This action is also not subject to
Executive Order 13045, 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 Policy on Children's Health applies to this
action.
This rule finalizes tolerance actions under the FFDCA, which
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 and other data and other relevant
information in support of these final tolerance actions. The Agency's
consideration is documented in the pesticide specific registration
review decision documents. See the discussion in Unit III. and access
the chemical specific registration review documents in each chemical
docket at https://www.regulations.gov.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not a 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 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
Executive Order 12898 (59 FR 7629, February 16, 1994) directs
Federal agencies, to the greatest extent practicable and permitted by
law, to make environmental justice part of their mission by identifying
and addressing, as appropriate, disproportionately high and adverse
human health or environmental effects of their programs, policies, and
activities on minority populations (people of color and/or indigenous
peoples) and low-income populations. As discussed in more detail in the
pesticide specific risk assessments conducted as part of the
registration review for the pesticides identified in Unit II., 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. EPA believes that the human health and environmental
conditions that exist prior to this action do not result in
disproportionate and adverse effects on people of color, low-income
populations, and/or indigenous peoples. Furthermore, EPA believes that
this action is not likely to result in new disproportionate and adverse
effects on people of color, low-income populations, and/or indigenous
peoples.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. 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: August 21, 2024.
Anita Pease,
Director, Antimicrobials 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. 180.940, amend table 1 to paragraph (a) by adding, in
alphabetical order, an entry for ``Tetraacetylethylenediamine (TAED)''
to read as follows:
[[Page 70106]]
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)
------------------------------------------------------------------------
Pesticide chemical CAS Reg. No. Limits
------------------------------------------------------------------------
* * * * * * *
Tetraacetylethylenediamine (TAED). 10543-57-4 None.
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2024-19448 Filed 8-28-24; 8:45 am]
BILLING CODE 6560-50-P
