Rule2022-05530
Tetraacetylethylenediamine (TAED) and Its Metabolite Diacetylethylenediamine (DAED); Exemption From the Requirement of a Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 17, 2022
Effective
March 17, 2022
Issuing agencies
Environmental Protection Agency
Abstract
This regulation amends an exemption from the requirement of a tolerance for residues of tetraacetylethylenediamine (TAED) and its metabolite diacetylethylenediamine (DAED) by expanding its use in or on all food commodities, when used as a fungicide and bactericide in accordance with label directions and good agricultural practices. The Lubrizol Corporation, 29400 Lakeland Blvd., Wickliffe, OH 44092, submitted a petition, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR 180.1327. 40 CFR 180.1327 currently provides for an exemption from the requirement of a tolerance for residues of the pesticide, tetraacetylethylenediamine (TAED), and its metabolite diacetylethylenediamine (DAED), in or on rice and strawberries, when used as a fungicide and bactericide in accordance with label directions and good agricultural practices. This regulation eliminates the need to establish a maximum permissible level for residues of tetraacetylethylenediamine (TAED) or its metabolite diacetylethylenediamine (DAED) when used in accordance with this exemption.
Full Text
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<title>Federal Register, Volume 87 Issue 52 (Thursday, March 17, 2022)</title>
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[Federal Register Volume 87, Number 52 (Thursday, March 17, 2022)]
[Rules and Regulations]
[Pages 15097-15100]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-05530]
[[Page 15097]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0551; FRL-9348-01-OCSPP]
Tetraacetylethylenediamine (TAED) and Its Metabolite
Diacetylethylenediamine (DAED); Exemption From the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation amends an exemption from the requirement of a
tolerance for residues of tetraacetylethylenediamine (TAED) and its
metabolite diacetylethylenediamine (DAED) by expanding its use in or on
all food commodities, when used as a fungicide and bactericide in
accordance with label directions and good agricultural practices. The
Lubrizol Corporation, 29400 Lakeland Blvd., Wickliffe, OH 44092,
submitted a petition, pursuant to section 408(d) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR
180.1327. 40 CFR 180.1327 currently provides for an exemption from the
requirement of a tolerance for residues of the pesticide,
tetraacetylethylenediamine (TAED), and its metabolite
diacetylethylenediamine (DAED), in or on rice and strawberries, when
used as a fungicide and bactericide in accordance with label directions
and good agricultural practices. This regulation eliminates the need to
establish a maximum permissible level for residues of
tetraacetylethylenediamine (TAED) or its metabolite
diacetylethylenediamine (DAED) when used in accordance with this
exemption.
DATES: This regulation is effective March 17, 2022. Objections and
requests for hearings must be received on or before May 16, 2022 and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0551, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (703) 305-7090; email address:
<a href="/cdn-cgi/l/email-protection#470517170301150928332e2422340722372669202831"><span class="__cf_email__" data-cfemail="6d2f3d3d292b3f230219040e081e2d081d0c430a021b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
<a href="https://www.ecfr.gov/current/title40">https://www.ecfr.gov/current/title40</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0551 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
May 16, 2022. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0551, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/contacts.html">https://www.epa.gov/dockets/contacts.html</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Background and Statutory Findings
In the Federal Register of September 22, 2021 (86 FR 52624) (FRL-
8792-03-OCSPP), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
tolerance petition (PP 9F8781) by The Lubrizol Corporation, 29400
Lakeland Blvd., Wickliffe, OH, 44092. The petition requested that 40
CFR 180.1327 be amended by amending the existing exemption from the
requirement of a tolerance for residues of tetraacetylethylenediamine
(TAED) and its metabolite diacetylethylenediamine (DAED) by expanding
it to in or on all food commodities, when used as a fungicide and
bactericide in accordance with label directions and good agricultural
practices. That document referenced a
[[Page 15098]]
summary of the petition prepared by the petitioner, The Lubrizol
Corporation, which is available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no comments received in response to the
notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.'' Additionally, FFDCA section 408(b)(2)(D) requires that the Agency
consider ``available information concerning the cumulative effects of a
particular pesticide's residues'' and ``other substances that have a
common mechanism of toxicity.''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm to human health. If EPA is
able to determine that a tolerance is not necessary to ensure that
there is a reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemical residue, an exemption from the
requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for TAED and DAED including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with TAED and DAED
follows.
A. Toxicological Profile
TAED is an analiphatic amide that is approved as a pesticide active
ingredient for food and non-food uses. It is also is listed by the Food
and Drug Administration (FDA) for use as a bleaching agent in the
manufacture of food-contact paper and paperboard products (21 CFR
176.170).
TAED rapidly degrades to form diacetylethylenediamine (DAED),
peroxyacetic acid (PAA), and hydrogen peroxide when exposed to water.
DAED is considered to be of similar or less toxicity than TAED.
Hydrogen peroxide and peroxyacetic acid are exempt from the requirement
of a tolerance under 40 CFR 180.1197 and 180.1196(c), respectively.
Food uses for TAED in or on rice and strawberries are supported by 40
CFR 180.1327, which currently provides for an exemption from the
requirement of a tolerance for residues TAED and DAED in or on rice and
strawberries, when used as a fungicide and bactericide in accordance
with label directions and good agricultural practices. As a non-food
pesticidal use, TAED is used on various non-bearing fruit trees,
ornamentals and grasses. For all uses, dietary exposure to TAED is
expected to be minimal due to TAED's physical and chemical properties
and ready biodegradation in the environment.
With regard to the overall toxicological profile, TAED is of
minimal toxicity. Based on acute studies, TAED is of low acute oral
toxicity and acute inhalation toxicity (Toxicity Category IV), low
acute dermal toxicity (Toxicity Category III) and is non-irritating to
the skin and eye (Toxicity Category IV). The chemical is not a skin
sensitizer. DAED is considered to be of similar or less toxicity than
TAED. All data requirements were satisfied by guideline studies for
subchronic toxicity (90-day oral, 90-day inhalation and 90-day dermal),
developmental toxicity, reproductive toxicity and mutagenicity data
requirements. There were no adverse subchronic effects for any oral or
dermal routes of exposure. The active ingredient was determined to be
non-mutagenic, and no adverse effects were identified relative to
either developmental toxicity or reproductive toxicity. Based on this
toxicological profile, EPA did not identify any toxicological endpoints
of concern for TAED.
B. Toxicological Points of Departure/Levels of Concern
No toxicological endpoint of concern has been identified for TAED
or DAED.
C. Exposure Assessment
1. Dietary exposure from food, feed uses, and drinking water. As
part of its qualitative risk assessment for TAED, the Agency considered
the potential for dietary exposure to residues of TAED and its
degradate, DAED. EPA concludes that dietary (food and drinking water)
exposures are likely to be negligible, due to the short half-life and
biodegradable nature of TAED and DAED. Further, biodegradation of TAED
and DAED yields the products water, nitrate, and ammonia, which are all
found naturally in the environment and readily metabolized by
microorganisms.
2. From non-dietary exposure. A revaluation of the risk of
occupational and residential (non-dietary) exposure to TAED and DAED
was not conducted at this time. Previous EPA risk assessments support
the uses on currently approved TAED product labels.
3. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' EPA has not found that TAED
or DAED share a common mechanism of toxicity with any other substances,
and they do not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed TAED and DAED do not have a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's website at
<a href="https://www.epa.gov/pesticides/cumulative">https://www.epa.gov/pesticides/cumulative</a>.
D. Safety Factor for Infants and Children
FFDCA Section 408(b)(2)(C) provides that EPA shall retain an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
[[Page 15099]]
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA safety factor (SF). In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor. An FQPA
safety factor is not required at this time for TAED and its metabolite,
DAED, because EPA has conducted a qualitative dietary assessment based
on low toxicity and anticipated negligible exposure to the active
ingredient.
E. Aggregate Risk
Based on the available data and information, the EPA has concluded
that a qualitative aggregate risk assessment is appropriate to support
the pesticidal use of TAED and its metabolite, DAED, and that risks of
concern are not anticipated from aggregate exposure to the substance or
its metabolite, DAED. This conclusion is based on the low toxicity of
the active ingredient and expected rapid degradation of TAED and DAED
in the environment.
A full explanation of the data upon which EPA relied and its risk
assessment based on those data can be found within the July 22, 2021,
document entitled ``Human Health Dietary Risk Assessment to Support a
Tolerance Exemption Amendment for Warwick AG610 (EPA Reg. No. 59825-6),
Containing 92% Tetraacetylethylenediamine as its Active Ingredient.''
This document, as well as other relevant information, is available in
the docket for this action as described under ADDRESSES.
IV. Determination of Safety for U.S. Population, Infants and Children
Based on the Agency's assessment, EPA concludes that there is
reasonable certainty that no harm will result to the U.S. population,
including infants and children, from aggregate exposure to residues of
TAED.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established an MRL for tetraacetylethylenediamine
(TAED) or its metabolite diacetylethylenediamine (DAED).
VI. Conclusions
Therefore, EPA is amending the currently established exemption for
residues of tetraacetylethylenediamine (TAED) and its metabolite
diacetylethylenediamine (DAED) to include use in or on all food
commodities--no longer limiting food use to strawberries and rice, when
used as a fungicide and bactericide in accordance with label directions
and good agricultural practices.
VII. Statutory and Executive Order Reviews
This action amends an exemption from the requirement of a tolerance
under FFDCA section 408(d) in response to a petition submitted to the
Agency. The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993).
Because this action has been exempted from review under Executive Order
12866, this action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive
Order 13045, entitled ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This
action does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
[[Page 15100]]
Dated: March 10, 2022.
Charles Smith,
Director, Biopesticides and Pollution Prevention 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. Revise Sec. 180.1327 to read as follows:
Sec. 180.1327 Tetraacetylethylenediamine (TAED) and its metabolite
Diacetylethylenediamine (DAED); Exemption from the Requirement of a
Tolerance.
An exemption from the requirement of a tolerance is established for
residues of the pesticide, tetraacetylethylenediamine (TAED), and its
metabolite diacetylethylenediamine (DAED), in or on all food
commodities, when used as a fungicide and bactericide in accordance
with label directions and good agricultural practices.
[FR Doc. 2022-05530 Filed 3-16-22; 8:45 am]
BILLING CODE 6560-50-P
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