[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 [www.gpo.gov]
[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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
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.
     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

[[Page 16715]]

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.

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].

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. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov 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 https://www.epa.gov/dockets/commenting-epa-dockets.

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 https://www.regulations.gov. 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 
https://www.regulations.gov 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 https://www.regulations.gov 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 https://www.regulations.gov. 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

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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).

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                        Table 1 to Paragraph (a)
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       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