Proposed Rule2024-04958
Tetraacetylethylenediamine (TAED), and Its Metabolite Diacetylethylenediamine (DAED); Exemption From the Requirement of a Pesticide Tolerance
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Published
March 8, 2024
Issuing agencies
Environmental Protection Agency
Abstract
EPA is proposing to exempt residues of the antimicrobial pesticide ingredient Tetraacetylethylenediamine (TAED), including its metabolites and degradates, from the requirement of a tolerance when used on or applied to food contact surfaces in public eating places, dairy processing equipment, and food processing equipment and utensils. This rulemaking is proposed 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 these chemicals as part of the Agency's registration review program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Full Text
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<title>Federal Register, Volume 89 Issue 47 (Friday, March 8, 2024)</title>
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[Federal Register Volume 89, Number 47 (Friday, March 8, 2024)]
[Proposed Rules]
[Pages 16714-16717]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-04958]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0208; FRL-11678-01-OCSPP]
RIN 2070-ZA16
Tetraacetylethylenediamine (TAED), and Its Metabolite
Diacetylethylenediamine (DAED); Exemption From the Requirement of a
Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to exempt residues of the antimicrobial
pesticide ingredient Tetraacetylethylenediamine (TAED), including its
metabolites and degradates, from the requirement of a tolerance when
used on or applied to food contact surfaces in public eating places,
dairy processing equipment, and food processing equipment and utensils.
This rulemaking is proposed 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 these chemicals
as part of the Agency's registration review program under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA).
DATES: Comments must be received on or before May 7, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2023-0208, 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 Confidential Business
Information (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
[[Page 16715]]
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>.
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#4030252133256e212e293421002530216e272f36"><span class="__cf_email__" data-cfemail="78081d190b1d561916110c19381d0819561f170e">[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 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:
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
<bullet> Restaurant kitchen cleaning services (NAICS code 561720).
<bullet> Milk production, dairy cattle (NAICS code 112120).
<bullet> Food processing machinery and equipment merchant
wholesalers (NAICS code 423830).
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
<a href="http://regulations.gov">regulations.gov</a> or email. Clearly mark the part or all of the
information that you claim to be CBI. In addition to one complete
version of the comment that includes information claimed as CBI, a copy
of the comment that does not contain the information claimed as CBI
must be submitted for inclusion in the public docket. 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>.
II. Background
A. What action is the Agency taking?
EPA is proposing to establish an exemption from the requirement of
a tolerance for residues of the antimicrobial pesticide
tetraacetylethylenediamine (TAED) and its metabolites and degradates on
food-contact surfaces in public eating places, dairy-processing
equipment, and food-processing equipment and utensils.
EPA is proposing this tolerance action to implement the tolerance
changes identified as necessary during the registration review
processes to cover these pesticide chemical residues when used in
antimicrobial formulations consistent with current label use
directions. Registration review documents, such as the draft risk
assessment, typically identify certain tolerance actions, including
modifications to reflect current use patterns, meet safety findings,
and change commodity names and groupings that may be necessary or
appropriate to cover pesticide chemical residues or reflect current EPA
policy.
For the pesticide chemicals at issue in this rulemaking, EPA issued
the TAED Interim Registration Review Decision (TAED ID) in April 2020.
Electronic copies of the TAED ID and other documents are available in
EPA docket number EPA-HQ-OPP-2013-0608, which can be found on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. EPA's risk assessment for TAED contains the
Agency's assessment of the potential risk associated with current
product uses, and based on the findings of that risk assessment, the
TAED ID identified the need to establish exemptions from the
requirement of a tolerance for residues of tetraacetylethylenediamine
(TAED) when used on or applied to food contact surfaces in public
eating places, dairy processing equipment, and food processing
equipment and utensils.
B. What is the Agency's authority for taking this action?
Section 408(e) of the FFDCA authorizes EPA to establish exemptions
from the requirement of a tolerance. 21 U.S.C. 346a(e)(1)(B). Before
issuing the final exemption, EPA is required to issue a proposed
rulemaking and provide a comment period of ``not less than 60 days''.
Id. at 346a(e)(2).
A ``tolerance'' represents the maximum level for residues of
pesticide chemicals legally allowed in or on raw agricultural
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a,
authorizes the establishment, modification, and revocation of
tolerances and exemptions from the requirement of a tolerance for
residues of pesticide chemicals in or on raw agricultural commodities
and processed foods. Residues of pesticides in or on food that are not
covered by a tolerance or exemption are deemed unsafe, 21 U.S.C.
408(a), and any food containing unsafe residues is considered
``adulterated'' under FFDCA section 402(a), 21 U.S.C. 342(a). Such food
may not be distributed in interstate commerce, 21 U.S.C. 331(a). For a
food-use pesticide to be sold and distributed in the United States, the
pesticide must not only have appropriate tolerances under the FFDCA,
but also must be registered under FIFRA, 7 U.S.C. 136 et seq. Moreover,
residues of food-use pesticides not registered in the United States
must also be covered by a U.S. tolerance or exemption in order for
commodities treated with those pesticides to be imported into the
United States.
Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of the 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.'' 21 U.S.C.
346a(c)(2)(A)(ii). This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(c)(2)(B) of the FFDCA requires EPA, when making a safety
determination concerning an exemption, to take into account, among
other relevant considerations, the considerations listed in section
408(b)(2)(C) and (D) of the FFDCA. Section 408(b)(2)(C) of the FFDCA
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. . . .'' Section 408(b)(2)(D) identifies various
factors, including available information on aggregate and cumulative
exposure, for EPA consideration in making a safety determination.
C. When do these actions become effective?
EPA is proposing that these tolerance actions become effective on
the date of publication of the final rule in the Federal Register.
III. Proposed Rule
EPA is proposing this rule to implement the tolerance actions
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identified in the TAED ID. EPA, on its own initiative, is proposing to
establish the necessary exemption under 40 CFR 180.940(a), which would
cover all food-contact uses of tetraacetylethylenediamine (TAED), from
the requirement of a tolerance when used on or applied to food-contact
surfaces in public eating places, dairy-processing equipment, and food-
processing equipment and utensils.
In order to establish tolerances or exemptions from the requirement
of a tolerance, EPA is required to determine that each tolerance or
exemption meets the safety standard of FFDCA. In its risk assessment
supporting the TAED ID, EPA considered the potential risks from
exposure to tetraacetylethylenediamine (TAED) from registered uses and
concluded that those uses did not present risks of concern. See U.S.
EPA, Registration Review Draft Risk Assessment for: TAED, available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> in docket ID number EPA-HQ-OPP-2013-0608.
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with FFDCA section 408(b)(2)(D), 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 to support the establishment
of an exemption from the requirement of a tolerance for residues of
tetraacetylethylenediamine (TAED) and its metabolites and degradates.
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime.
EPA's risk assessment for tetraacetylethylenediamine (TAED), can be
found in full at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in docket ID number EPA-
HQ-OPP-2013-0608. That risk assessment explains EPA's analysis of the
toxicity of the pesticide chemicals as well as the selection of
toxicological points of departure and levels of concern for use in
evaluating the risk posed by human exposure to the pesticide.
TAED exhibits low hazard via the oral route of exposure. The Agency
anticipates exposures to negligible levels of TAED residues from food
transfer based on the chemical properties and the rapid degradation of
the chemical to form peroxyacetic acid (PAA). TAED is a bleach
activator and reacts with an oxygen activator (e.g., sodium
percarbonate) and undergoes rapid hydrolysis under alkaline conditions
to yield PAA, hydrogen peroxide, and diacetylethylenediamine (DAED). A
short-lived, intermediate tri-acetyl ethylene diamine (triAED) is
formed prior to DAED. The remaining acetyl groups on DAED cannot be
further displaced by peroxide. TAED is essentially a carrier molecule
for PAA, the active moiety. When formed, PAA and hydrogen peroxide are
extremely powerful oxidizers and are the active components that will
exhibit pesticidal activity.
In addition, EPA's risk assessment considered exposure to TAED
based on the maximum label rate for commercial use of TAED as an
antimicrobial or biochemical product.
Based on the Agency's risk assessment, no dietary or aggregate
risks of concern were identified for tetraacetylethylenediamine (TAED)
or its metabolites or degradates. The physical-chemical properties of
both TAED and DAED are very similar and TAED largely metabolizes to
DAED in vivo. DAED is expected to be of similar or less toxicity than
TAED and will be present in reduced quantities compared to TAED.
Although TAED use may result in indirect dietary food contact, based on
its chemical properties, TAED is expected to rapidly form peracetic
acid to impart antimicrobial action needed to disinfect or sanitize
surfaces. Residues of peracetic acid have been determined to be safe,
as confirmed by the Peroxy Compounds Registration Review Case.
Information regarding the Peroxy Compounds Registration Review Case can
be found using docket ID EPA-HQ-OPP-2009-0546 at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Therefore, the Agency anticipates negligible
residues to be available for transfer to food and a quantitative
chronic dietary exposure and risk assessment was not conducted.
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, including its metabolites and degradates, is safe, i.e., there is
a reasonable certainty that no harm will result from aggregate
exposures to TAED, when used in accordance with the terms of the
respective exemptions. In addition, due to the lack of toxicity, 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).
V. Conclusion
Therefore, EPA is proposing to establish an exemption in 40 CFR
180.940(a) for residues of the antimicrobial pesticide ingredient TAED,
including its metabolites and degradates, from the requirement of a
tolerance when used on or applied to food-contact surfaces in public
eating places, dairy-processing equipment, and food-processing
equipment and utensils.
VI. Statutory and Executive Order Reviews
In this proposed rule, EPA is proposing to exempt residues of the
antimicrobial pesticide ingredient TAED, including its metabolites and
degradates, from the requirement of a tolerance under FFDCA section
408(e). The Office of Management and Budget (OMB) has exempted these
types of actions (e.g., establishment and modification of a tolerance
and tolerance revocation for which extraordinary circumstances do not
exist) from review under Executive Order 12866, entitled ``Regulatory
Planning and Review'' (58 FR 51735, October 4, 1993). Because this
proposed rule has been exempted from review under Executive Order 12866
due to its lack of significance, this proposed rule 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). This proposed rule does not contain any
information
[[Page 16717]]
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.) or 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.). Nor does
it require any special considerations as required by Executive Order
12898, entitled ``Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations'' (59 FR 7629, February
16, 1994); or OMB review or any other Agency action under Executive
Order 13045, entitled ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This
proposed rule 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). Pursuant to the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously
assessed whether establishment of tolerances, exemptions from
tolerances, raising of tolerance levels, expansion of exemptions, or
revocations might significantly impact a substantial number of small
entities and concluded that, as a general matter, these actions do not
impose a significant economic impact on a substantial number of small
entities. These analyses for tolerance establishments and
modifications, and for tolerance revocations were published in the
Federal Register of May 4, 1981 (46 FR 24950) and December 17, 1997 (62
FR 66020) (FRL-5753-1), respectively, and were provided to the Chief
Counsel for Advocacy of the Small Business Administration. Taking into
account this analysis, and available information concerning the
pesticides listed in this proposed rule, the Agency hereby certifies
that this proposed rule will not have a significant negative economic
impact on a substantial number of small entities. Furthermore, for the
pesticide named in this proposed rule, the Agency knows of no
extraordinary circumstances that exist as to the present proposed rule
that would change EPA's previous analysis. Any comments about the
Agency's determination should be submitted to the EPA along with
comments on the proposed rule and will be addressed prior to issuing a
final rule. In addition, the Agency has determined that this proposed
rule will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999). Executive Order 13132,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that 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.'' This proposed rule directly regulates
growers, food processors, food handlers, and food retailers, not
States. This proposed rule does not alter the relationships or
distribution of power and responsibilities established by Congress in
the preemption provisions of FFDCA section 408(n)(4). For these same
reasons, the Agency has determined that this proposed rule does not
have any ``tribal implications'' as described in Executive Order 13175
entitled ``Consultation and Coordination with Indian Tribal
Governments'' (65 FR 67249, November 9, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on one or more Indian tribes, 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.'' This proposed rule will not
have substantial direct effects on tribal governments, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175, does not apply to this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 29, 2024.
Michael Goodis,
Deputy Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended 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:
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
* * * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Pesticide chemical CAS reg. No. Limits
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* * * * * * *
Tetraacetylethylenediamine 10543-57-4 None.
(TAED).
* * * * * * *
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* * * * *
[FR Doc. 2024-04958 Filed 3-7-24; 8:45 am]
BILLING CODE 6560-50-P
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