Aspergillus flavus NRRL 21882; Amendment to an Exemption From the Requirement of a Tolerance, 60368-60370 [2020-21107]
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60368
Federal Register / Vol. 85, No. 187 / Friday, September 25, 2020 / Rules and Regulations
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 2, 2020.
Edward Messina,
Acting Director, 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
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1379 to subpart D to read
as follows:
■
§ 180.1379 Trichoderma asperellum, strain
T34; exemption from the requirement of a
tolerance.
An exemption from the requirement
of a tolerance is established for residues
of Trichoderma asperellum, strain T34
in or on all food commodities when
used in accordance with label directions
and good agricultural practices.
[FR Doc. 2020–20653 Filed 9–24–20; 8:45 am]
BILLING CODE 6560–50–P
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
Environmental Protection
Agency (EPA).
ACTION: Final rule.
I. General Information
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
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:
AGENCY:
SUMMARY:
khammond on DSKJM1Z7X2PROD with RULES
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:
VerDate Sep<11>2014
16:28 Sep 24, 2020
Jkt 250001
A. Does this action apply to me?
PO 00000
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• 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/textidx?&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.
E:\FR\FM\25SER1.SGM
25SER1
Federal Register / Vol. 85, No. 187 / Friday, September 25, 2020 / Rules and Regulations
• 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-sendcomments-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-epadockets.
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
khammond on DSKJM1Z7X2PROD with RULES
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
VerDate Sep<11>2014
16:28 Sep 24, 2020
Jkt 250001
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;
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60369
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
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60370
Federal Register / Vol. 85, No. 187 / Friday, September 25, 2020 / Rules and Regulations
‘‘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).
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
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Revise § 180.1254 to read as
follows:
khammond on DSKJM1Z7X2PROD with RULES
■
§ 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
16:28 Sep 24, 2020
Jkt 250001
[FR Doc. 2020–21107 Filed 9–24–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 228
[EPA–R01–OW–2019–0521; FRL–10014–99–
Region 1]
Ocean Disposal; Designation of an
Ocean Dredged Material Disposal Site
for the Southern Maine, New
Hampshire, and Northern
Massachusetts Coastal Region
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
VI. Congressional Review Act
VerDate Sep<11>2014
label directions and good agricultural
practices.
With the publication of this
Final Rule, the Environmental
Protection Agency (EPA) is designating
one ocean dredged material disposal site
(ODMDS), the Isles of Shoals North
Disposal Site (IOSN), located in the Gulf
of Maine off the coast of southern Maine
and New Hampshire, pursuant to the
Marine Protection, Research, and
Sanctuaries Act (MPRSA). This action is
necessary to serve the long-term need
for an ODMDS for the possible future
disposal of suitable dredged material
from harbors and navigation channels in
southern Maine, New Hampshire, and
northern Massachusetts. The basis for
this action is described herein and in
the Final Environmental Assessment
(FEA). The FEA identifies designation of
the IOSN as the preferred alternative
from the range of options considered.
The Site Management and Monitoring
Plan (SMMP) is provided as Appendix
G of the FEA.
DATES: The Final rule is effective on
October 26, 2020.
ADDRESSES: EPA has established a
docket for this action under Docket
Identification No. EPA–R01–OW–2019–
0521, through the Federal eRulemaking
Portal: https://www.regulations.gov.
Docket: Publicly available docket
materials are available either
electronically at regulations.gov or on
the EPA Region 1 Ocean Dumping web
page at https://www.epa.gov/oceandumping/isles-shoals-north-disposalsite. They are also available in hard
copy during normal business hours at
the EPA Region 1 Library, 5 Post Office
Square, Boston, MA 02109.
The supporting document for this site
designation is the Final Environmental
Assessment for Designation of an Ocean
Dredged Material Disposal Site for the
SUMMARY:
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Southern Maine, New Hampshire, and
Northern Massachusetts Coastal Region.
FOR FURTHER INFORMATION CONTACT: Ms.
Regina Lyons, U.S. Environmental
Protection Agency, Region 1, 5 Post
Office Square, Suite 100, Mail Code: 06–
1, Boston, MA 02109–3912, telephone:
(617) 918–1557; fax: (617) 918–0557;
email address: lyons.regina@epa.gov.
SUPPLEMENTARY INFORMATION:
Organization of this document. The
following outline is provided to aid in
locating information in this preamble.
I. Final Action
II. Background
III. Purpose and Need
IV. Disposal Site Description
V. Potentially Affected Entities
VI. Summary of Public Comments and EPA’s
Response
VII. Compliance With Statutory and
Regulatory Authorities
A. Marine Protection, Research, and
Sanctuaries Act
B. National Environmental Policy Act
C. Coastal Zone Management Act
D. Endangered Species Act
E. Magnuson-Stevens Fishery Conservation
and Management Act
VIII. Supporting Documents
IX. Statutory and Executive Order Reviews
I. Final Action
EPA is publishing this Final Rule to
designate the IOSN for the purpose of
providing an ocean disposal option for
possible use in managing dredged
material from harbors and navigation
channels in the southern Maine, New
Hampshire, and northern Massachusetts
coastal region. The site designation is
effective for an indefinite period of time.
Without designation of this ODMDS,
there will not be an ocean disposal site
available to serve this region after
December 31, 2021, when the current
Congressionally-authorized term of use
for the Cape Arundel Disposal Site
(CADS) expires. Use of the IOSN is
subject to any restrictions and
procedures included in the site
designation and the approved SMMP.
These restrictions are based on a
thorough evaluation of the site pursuant
to the Ocean Dumping Regulations,
potential disposal activity expected at
the site, and consideration of public
review and comment. Additional
restrictions may be placed on any
permit or authorization to use the site.
The site designation process has been
conducted pursuant to the requirements
of the MPRSA, Coastal Zone
Management Act (CZMA), and other
applicable federal and state statutes and
regulations. Compliance with these
requirements is described in detail in
Section VII (‘‘Compliance with Statutory
and Regulatory Requirements’’). The
basis for this federal action is further
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
[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 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
