Document ID: EPA-HQ-OPP-2019-0692-0005
Agency: epa
Document Type: Rule
Title: Amendment to an Exemption from the Requirement of a Tolerance: Aspergillus flavus NRRL 21882
Posted Date: 2020-09-25T04:00Z

[Federal Register Volume 85, Number 187 (Friday, September 25, 2020)]
[Rules and Regulations]
[Pages 60368-60370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21107]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0692; FRL-10014-38]

Aspergillus flavus NRRL 21882; Amendment to an Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the existing tolerance exemptions for 
residues of Aspergillus flavus NRRL 21882 in or on corn and peanut 
commodities by clarifying that the exemption covers all food and feed 
commodities of these crops and by establishing an exemption for all 
food and feed commodities of almond and pistachio. Syngenta Crop 
Protection, LLC submitted a petition to EPA under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), requesting that EPA amend the existing 
tolerance exemption for Aspergillus flavus NRRL 21882. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of Aspergillus flavus NRRL 21882 on these crops.

DATES: This regulation is effective September 25, 2020. Objections and 
requests for hearings must be received on or before November 24, 2020 
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-2019-0692, is available at 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the EPA 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 https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Anne Overstreet, 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: 
BPPDFRNotices@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 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 40 CFR 
part 180 through the Government Publishing Office's e-CFR site at 
https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2019-0692 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 
November 24, 2020. 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-2019-0692, 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.

[[Page 60369]]

     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 dockets generally, is available at https://www.epa.gov/dockets/about-epa-dockets.

II. Background

    In the Federal Register of February 10, 2020 (85 FR 7499) (FRL-
10004-54), 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 
exemption petition (PP 9F8780) by Syngenta Crop Protection, LLC, 410 
South Swing Rd., Greensboro, NC 27409. The petition requested that 40 
CFR 180.1254 be amended by establishing an exemption from the 
requirement of a tolerance for residues of the fungicide Aspergillus 
flavus NRRL 21882 in or on almond and pistachio. That document 
referenced a summary of the petition prepared by the petitioner 
Syngenta Crop Protection, LLC and is available in the docket via 
https://www.regulations.gov. No comments were received on the notice of 
filing.
    Since the time the original notice of filing was published, the 
petitioner provided a revised petition requesting a revision to the 
existing tolerance exemption to include all food and feed commodities 
of almond; corn, field; corn, pop; corn, sweet; peanut; and pistachio. 
In order to give the public an opportunity to comment on this new 
information, EPA published its receipt of this revised petition in the 
Federal Register of June 1, 2020 (85 FR 33059) (FRL-10009-29) and 
placed a revised petition from Syngenta Crop Protection, LLC into the 
docket. No comments were received in response to the republished notice 
of filing.

III. Final Rule

A. EPA's safety determination

    Section 408(c)(2)(A)(i) of 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 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 or tolerance exemption 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 EPA consider ``available information concerning the 
cumulative effects of [a particular pesticide's] . . . residues and 
other substances that have a common mechanism of toxicity.''
    EPA evaluated the available toxicological and exposure data on 
Aspergillus flavus NRRL 21882 and considered their validity, 
completeness, and reliability, as well as the relationship of this 
information to human risk. A full explanation of the data upon which 
EPA relied can be found in the preamble to the 2004 tolerance exemption 
in the Federal Register of June 30, 2004 (69 FR 39341) (FRL-7364-2) and 
in its risk assessment entitled ``Federal Food, Drug, and Cosmetic Act 
(FFDCA) Safety Determination for Aspergillus flavus NRRL 21882'' 
(Safety Determination Document). The Safety Determination Document, as 
well as other relevant information, is available in the docket for this 
action as described under ADDRESSES. Based upon its evaluation in the 
Safety Determination Document, EPA concludes that there is a reasonable 
certainty that no harm will result to the U.S. population, including 
infants and children, from aggregate exposure to residues of 
Aspergillus flavus NRRL 21882.

B. Analytical Enforcement Methodology

    An analytical method is not required for Aspergillus flavus NRRL 
21882 because EPA is amending an exemption from the requirement of a 
tolerance without any numerical limitation.

IV. Conclusion

    Therefore, the existing tolerance exemption for Aspergillus flavus 
NRRL 21882 is amended by establishing an exemption from the requirement 
of tolerance for residues of Aspergillus flavus NRRL 21882 in or on all 
food and feed commodities of almond; corn, field; corn, pop; corn, 
sweet; peanut; and pistachio when used in accordance with label 
directions and good agricultural practices.

V. Statutory and Executive Order Reviews

    This action modifies and establishes tolerance exemptions under 
FFDCA section 408(d) in response to a petition submitted to EPA. 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), nor is it 
considered a regulatory action under Executive Order 13771, entitled 
``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, 
February 3, 2017). This action does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act, 
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 modified on the basis of a 
petition under FFDCA section 408(d), such as the tolerance exemption in 
this action, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (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. As a result, this 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, EPA 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, EPA determined that 
Executive Order 13132, entitled

[[Page 60370]]

``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 (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require EPA's consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (15 U.S.C. 272 note).

VI. 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: September 17, 2020.
Jean Overstreet,
Acting 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.  180.1254 to read as follows:

Sec.  180.1254  Aspergillus flavus NRRL 21882; exemption from the 
requirement of a tolerance.

    Residues of Aspergillus flavus NRRL 21882 are exempt from the 
requirement of a tolerance in or on all food and feed commodities of 
almond; corn, field; corn, pop; corn, sweet; peanut; and pistachio when 
used in accordance with label directions and good agricultural 
practices.

[FR Doc. 2020-21107 Filed 9-24-20; 8:45 am]
BILLING CODE 6560-50-P