[Federal Register Volume 87, Number 15 (Monday, January 24, 2022)]
[Rules and Regulations]
[Pages 3446-3449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01248]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0352; FRL-9419-01-OCSPP]
Nitrapyrin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
nitrapyrin in or on cottonseed, crop subgroup 20C; cotton, gin
byproducts; cotton, meal; rice, grain; and rice, straw. Corteva
Agrosciences requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective January 24, 2022. Objections and
requests for hearings must be received on or before March 25, 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-2021-0352, 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 is (202) 566-1744, and the telephone number for the OPP
Docket is (202) 566-0294.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is open to visitors by
appointment only. For the latest status information on EPA/DC services
and access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Anita Pease, Antimicrobials Division
(7510P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number: (703) 305-7090; 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 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:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
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 EPA's
tolerance regulations at 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-2021-0352 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
March 25, 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-2021-0352, 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/where-send-comments-epa-dockets.
Additional instructions on commenting or visiting the docket, along
with more information about
[[Page 3447]]
dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of August 24, 2021 86 FR 47275 (FRL-8792-
02-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 petition (PP
0F8875) by Corteva Agrosciences, 9330 Zionsville Rd., Indianapolis, IN
46268. The petition requested that 40 CFR 180.350 be amended by
establishing a tolerance for combined residues or residues of the
nitrification inhibitor nitrapyrin and its metabolite, 6-
chloropicolinic acid (6-CPA), in or on cottonseed crop subgroup 20C;
cotton, gin byproducts; cotton, meal; rice, grain; and rice, straw at
4.0, 0.6, 6.0, 0.03 and 0.15 parts per million (ppm), respectively.
That document referenced a summary of the petition prepared by Corteva
Agrosciences, the registrant, which is included in the docket. There
were no comments received in response to the notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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(b)(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.
Section 408(b)(2)(C) of 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 . .
. .''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in 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 for a tolerance for combined
residues or residues of nitrapyrin and its metabolite, 6-
chloropicolinic acid (6-CPA), in or on cottonseed crop subgroup 20C;
cotton, gin byproducts; cotton, meal; rice, grain; and rice, straw at
4.0, 0.6, 6.0, 0.03 and 0.15 parts per million (ppm), respectively.
EPA's assessment of exposures and risks associated with establishing
the tolerance follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemaking of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemaking and republishing the same sections is unnecessary.
EPA considers referral back to those sections as sufficient to provide
an explanation of the information EPA considered in making its safety
determination for the new rulemaking.
EPA has previously published a number of tolerance rulemakings for
nitrapyrin, in which EPA concluded, based on the available information,
that there is a reasonable certainty that no harm would result from
aggregate exposure to nitrapyrin and established tolerances for
residues of that chemical. EPA is incorporating previously published
sections from those rulemakings as described further in this
rulemaking, as they remain unchanged. On August 27, 2019, EPA published
in the Federal Register a final rule establishing tolerances for
residues of nitrapyrin in or on sugar beet molasses, sugar beet roots,
sugar beet tops, rapeseed seed, and the vegetable, tuberous and corm,
crop subgroup 1C. See (85 FR 48651) (FRL-10009-42). That document
contains a summary of the toxicological profile, assumptions for
dietary exposure assessment, cumulative risk, and the safety factor for
children, which have not changed. More detailed information on the
subject action to establish a tolerance in or on cotton and rice can be
found in the document titled, ``Nitrapyrin. Human Health Risk
Assessment for New Uses in/on Cotton and Rice,'' dated December 8, 2021
by going to https://www.regulations.gov. The referenced document is
available in the docket EPA-HQ-OPP-2021-0352.
Toxicological profile. For a discussion of the Toxicological
Profile of nitrapyrin, see Unit III of the August 12, 2020 rulemaking
(85 FR 48651) (FRL-10009-42). There have been no changes to the
toxicological endpoints since the last risk assessment.
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for
nitrapyrin, see the document titled: ``Nitrapyrin. Human Health Risk
Assessment for New Uses in/on Cotton and Rice,'' dated December 8,
2021, in docket number EPA-HQ-OPP-2021-0352.
Exposure assessment. EPA's dietary exposure assessments have been
updated to include the additional exposure from the new uses of
nitrapyrin on cotton and rice. The assessment used the same assumptions
as the August 12, 2020 final rule concerning tolerance-level residues,
default processing factors for all processed commodities, and 100
percent crop treated.
Drinking water exposure. EPA has revised the nitrapyrin drinking
water assessment since the August 12, 2020 final rule. Surface water
and groundwater modeling were simulated using the Pesticide in Water
Calculator (PWC version 2.0; Sep. 18, 2020) for use on cotton. The
Pesticides in Flooded Applications Model (PFAM; version 2.0; Sep. 27,
2016) was also used in surface water modeling for use on rice. The
highest estimated drinking water concentrations (EDWCs) are 124 [mu]g/L
for acute exposure and 111 [micro]g/L for chronic exposure from ground
water sources based on the Florida (FL) central ridge model scenarios.
Non-occupational exposure. There are no currently registered or
proposed residential uses for nitrapyrin; therefore, residential
handler and post-application exposure and risks were not assessed.
Cumulative exposures. Unlike other pesticides for which EPA has
followed a cumulative risk approach based on a common mechanism of
toxicity, EPA has not made a common mechanism of toxicity finding as to
nitrapyrin and any other substances and nitrapyrin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this action, therefore, EPA has not assumed that nitrapyrin
has a common mechanism of toxicity with other substances.
Safety factor for infants and children. EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor. See Unit III of the August
12, 2020 final rule for a discussion of the Agency's rationale for that
determination.
Aggregate risk and determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
aggregate exposure estimates to the acute population adjusted dose
(aPAD) and the chronic population adjusted dose (cPAD). Short-,
intermediate-, and chronic term risks are evaluated by
[[Page 3448]]
comparing the estimated aggregate food, water, and residential exposure
to the appropriate points of departure to ensure that an adequate
margin of exposure (MOE) exists. For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure.
The acute dietary (food and water) risk estimates are below EPA's
level of concern for all population subgroups (<100% of the acute
population adjusted dose (aPAD)). The population subgroup with the
highest acute risk estimate is all-infants (<1 year-old), at 14% of the
aPAD. The chronic dietary (food and water) risk estimates are below
HED's level of concern for all population subgroups (<100% of the
chronic adjusted population dose (cPAD)). The population subgroup with
the highest chronic risk estimate is children (1 to 2 years old) at 26%
of the cPAD.
Since there are no registered residential uses, the acute and
chronic aggregate exposure and risk assessment are equivalent to the
dietary (food and drinking water) exposure and risk estimates and are
below EPA's level of concern (<26% of the cPAD). Nitrapyrin is
classified as ``not likely to be carcinogenic to humans at doses that
do not result in constitutive androstane receptor (CAR) activation as
indicated by Cyp2b10 expression''. Therefore, the chronic dietary
endpoint and assessment are protective of all chronic risks, including
potential carcinogenic effects. More detailed information can be found
at https://www.regulations.gov in the document titled ``Nitrapyrin.
Human Health Risk Assessment for the Section 3 Registration Action for
New Uses on in/on Cotton and Rice,'' dated December 8, 2021 by going to
https://www.regulations.gov. The referenced document is available in
the docket EPA-HQ-OPP-2021-0352.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography with electron
capture detection) is available to enforce the tolerance expression.
Seven analytical methods are available in Volume II of the Pesticide
Analytical Manual (PAM II--Pesticide Reg. Sec. 180.350) for tolerance
enforcement for nitrapyrin and/or for metabolite 6-CPA.
B. International Residue Limits
Codex and Canada have not established maximum residue limits (MRLs)
for residues of nitrapyrin. Therefore, there are no issues related to
international harmonization. A summary of the MRLs can be found in
Appendix D of the document titled ``Nitrapyrin. Human Health Risk
Assessment for the Section 3 Registration Action for New Uses on in/on
Cotton and Rice,'' dated December 8, 2021 by going to https://www.regulations.gov. The referenced document is available in the docket
EPA-HQ-OPP-2021-0352.
C. Revisions to Petitioned-For Tolerances
Rice straw is no longer considered a significant livestock feed
item and a tolerance is therefore unnecessary. Additionally, tolerance
values for cottonseed crop subgroup 20C, cotton, gin byproducts and
cotton meal are being established consistent with the Agency's rounding
class practice.
V. Conclusion
Therefore, tolerances are established for the residues of
nitrapyrin in or on cottonseed crop subgroup 20C at 4 parts per million
(ppm); cotton, gin byproducts at 0.6 ppm; cotton, meal at 6 ppm; and
rice, grain at 0.03 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances 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 tolerances 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).
VII. 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.
Dated: January 19, 2022.
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:
[[Page 3449]]
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. 180.350, amend the table in paragraph (a) by adding a table
heading and, in alphabetical order, the entries ``Cottonseed subgroup
20C''; ``Cotton, gin byproduct''; ``Cotton, meal''; and ``Rice, grain''
to read as follows:
Sec. 180.350 Nitrapyrin; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Cottonseed subgroup 20C................................. 4
Cotton, gin byproduct................................... 0.6
Cotton, meal............................................ 6
* * * * *
Rice, grain............................................. 0.03
* * * * *
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[FR Doc. 2022-01248 Filed 1-21-22; 8:45 am]
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