Saccharomyces cerevisiae Strain LAS02; Exemption From the Requirement of a Tolerance, 5709-5711 [2022-02099]
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Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Rules and Regulations
FOR FURTHER INFORMATION CONTACT:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2021–0139; FRL–9253–01–
OCSPP]
Saccharomyces cerevisiae Strain
LAS02; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
I. General Information
AGENCY:
A. Does this action apply to me?
This regulation establishes an
exemption from the requirement of a
tolerance for residues of Saccharomyces
cerevisiae strain LAS02 in or on all food
commodities when used in accordance
with label directions and good
agricultural practices. Lesaffre Yeast
Corporation (c/o Wagner Regulatory
Associates, Inc.) submitted a petition to
EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting an
exemption from the requirement of a
tolerance. This regulation eliminates the
need to establish a maximum
permissible level for residues of
Saccharomyces cerevisiae strain LAS02
under FFDCA when used in accordance
with this exemption.
DATES: This regulation is effective
February 2, 2022. Objections and
requests for hearings must be received
on or before April 4, 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).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2021–0139, 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 (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.
jspears on DSK121TN23PROD with RULES1
ADDRESSES:
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16:37 Feb 01, 2022
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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:
BPPDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
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 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(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–2021–0139 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 April
4, 2022. Addresses for mail and hand
delivery of objections and hearing
requests are provided in 40 CFR
178.25(b), although EPA strongly
encourages those interested in
submitting objections or a hearing
request, to submit objections and
hearing requests electronically. See
Order Urging Electronic Service and
Filing (April 10, 2020), https://
www.epa.gov/sites/production/files/
PO 00000
Frm 00055
Fmt 4700
Sfmt 4700
5709
2020-05/documents/2020-04-10_-_
order_urging_electronic_service_and_
filing.pdf. At this time, because of the
COVID–19 pandemic, the judges and
staff of the Office of Administrative Law
Judges are working remotely and not
able to accept filings or correspondence
by courier, personal delivery, or
commercial delivery, and the ability to
receive filings or correspondence by
U.S. Mail is similarly limited. When
submitting documents to the U.S. EPA
Office of Administrative Law Judges
(OALJ), a person should utilize the
OALJ e-filing system, at https://
yosemite.epa.gov/OA/EAB/EAB-ALJ_
upload.nsf.
Although EPA’s regulations require
submission via U.S. Mail or hand
delivery, EPA intends to treat
submissions filed via electronic means
as properly filed submissions during
this time that the Agency continues to
maximize telework due to the
pandemic; therefore, EPA believes the
preference for submission via electronic
means will not be prejudicial. If it is
impossible for a person to submit
documents electronically or receive
service electronically, e.g., the person
does not have any access to a computer,
the person shall so advise OALJ by
contacting the Hearing Clerk at (202)
564–6281. If a person is without access
to a computer and must file documents
by U.S. Mail, the person shall notify the
Hearing Clerk every time it files a
document in such a manner. The
address for mailing documents is U.S.
Environmental Protection Agency,
Office of Administrative Law Judges,
Mail Code 1900R, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
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–
2021–0139 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\02FER1.SGM
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5710
Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / 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/where-sendcomments-epa-dockets.
II. Background
In the Federal Register of September
22, 2021 (86 FR 52624) (FRL–8792–03),
EPA issued a notice pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
tolerance exemption petition (PP
0F8841) by Lesaffre Yeast Corporation
(c/o Wagner Regulatory Associates,
Inc.,) P.O. Box 640, 7217 Lancaster Pike,
Suite A, Hockessin, DE 19707. The
petition requested that 40 CFR part 180
be amended by establishing an
exemption from the requirement of a
tolerance for residues of the bactericide
and fungicide Saccharomyces cerevisiae
strain LAS02 in or on all food
commodities. That notice referenced a
summary of the petition prepared by the
petitioner Lesaffre Yeast Corporation
and available in the docket via https://
www.regulations.gov. No comments
were received on the notice of filing.
III. Final Rule
jspears on DSK121TN23PROD with RULES1
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
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16:37 Feb 01, 2022
Jkt 256001
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
Saccharomyces cerevisiae strain LAS02
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 and its risk
assessment based on those data can be
found within the document entitled
‘‘Human Health Risk Assessment of the
New Active Ingredient Saccharomyces
cerevisiae strain LAS02 in the Proposed
End-use Product EPA File Symbol
91810–G with an Associated Tolerance
Exemption Petition’’ (Saccharomyces
cerevisiae strain LAS02 Human Health
Assessment). This document, as well as
other relevant information, is available
in the docket for this action as described
under ADDRESSES.
The available data and rationale
supported by existing scientific
literature on Saccharomyces cerevisiae
strain LAS02 and related
Saccharomyces cerevisiae species
demonstrate that, with regard to
humans, Saccharomyces cerevisiae
strain LAS02 is not toxic, pathogenic, or
infective via any reasonably foreseeable
route of exposure. Humans, including
infants and children, are naturally
exposed to Saccharomyces cerevisiae as
this microorganism is commonly found
in many habitats including soil, water,
and plant surfaces. Furthermore,
humans, including infants and children,
have a long history of safe dietary
exposure to strains of Saccharomyces
cerevisiae through their use in food
production, nutritional supplements,
and bio-therapeutics. Saccharomyces
cerevisiae strain LAS02 is expected to
be non-toxic, non-pathogenic, and noninfective based on its genetic similarity
to other food-use Saccharomyces
cerevisiae strains and its lack of genetic
modification.
Although there may be some dietary
and non-occupational exposures to
pesticide residues of Saccharomyces
cerevisiae strain LAS02 when used in
accordance with label directions and
good agricultural practices, there is not
a concern due to the lack of potential for
adverse effects. Humans have a long
history of dietary exposure of
Saccharomyces cerevisiae through its
use in food and supplement products
and natural exposure through its
PO 00000
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Fmt 4700
Sfmt 4700
presence in the environment with no
reported significant adverse effects
attributable to dietary or nonoccupational exposure based on the
proposed pesticide uses. Because there
are no threshold levels of concern with
the toxicity, pathogenicity, or infectivity
of Saccharomyces cerevisiae strain
LAS02, EPA determined that no
additional margin of safety is necessary
to protect infants and children as part of
the qualitative assessment conducted.
Based upon its evaluation in the
Saccharomyces cerevisiae strain LAS02
Human Health Assessment, which
concludes that there are no risks of
concern from aggregate exposure to
Saccharomyces cerevisiae strain LAS02,
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 Saccharomyces cerevisiae
strain LAS02.
B. Analytical Enforcement Methodology
An analytical method is not required
for Saccharomyces cerevisiae strain
LAS02 because EPA is establishing an
exemption from the requirement of a
tolerance without any numerical
limitation.
C. Conclusion
Therefore, an exemption from the
requirement of a tolerance is established
for residues of Saccharomyces
cerevisiae strain LAS02 in or on all food
commodities when used in accordance
with label directions and good
agricultural practices.
IV. Statutory and Executive Order
Reviews
This action establishes a tolerance
exemption 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). 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
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Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Rules and Regulations
jspears on DSK121TN23PROD with RULES1
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 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 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, EPA 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 (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).
V. 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.
VerDate Sep<11>2014
16:37 Feb 01, 2022
Jkt 256001
Dated: January 14, 2022.
Edward Messina,
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 § 180.1391 to subpart D to read
as follows:
■
§ 180.1391 Saccharomyces cerevisiae
strain LAS02; exemption from the
requirement of a tolerance.
An exemption from the requirement
of a tolerance is established for residues
of Saccharomyces cerevisiae strain
LAS02 in or on all food commodities
when used in accordance with label
directions and good agricultural
practices.
[FR Doc. 2022–02099 Filed 2–1–22; 8:45 am]
BILLING CODE 6560–50–P
GENERAL SERVICES
ADMINISTRATION
41 CFR Part 102–77
[FMR Case 2021–02; Docket No. GSA–FMR–
2021–0024, Sequence No. 1]
RIN 3090–AK47
Federal Management Regulation; Art in
Architecture
Office of Government-wide
Policy (OGP), General Services
Administration (GSA).
ACTION: Final rule with 60-day comment
period.
AGENCIES:
GSA is issuing a final rule
amending the Federal Management
Regulation (FMR) to update certain
provisions of the Art in Architecture
program. These revisions clarify the
policies to collect, manage, fund, and
commission visual art in Federal
buildings. The rule updates policies
consistent with the requirements of the
Executive Order (E.O.) issued May 14,
2021, titled ‘‘Revocation of Certain
Presidential Actions and Technical
Amendment.’’ The rule also supports
the goals of the E.O. issued January 20,
2021, titled ‘‘Advancing Racial Equity
and Support for Underserved
Communities Through the Federal
Government.’’
SUMMARY:
DATES:
PO 00000
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5711
Effective date: January 31, 2022.
Comments due date: Please submit
comments by the method listed in the
ADDRESSES section by April 4, 2022 for
consideration in future rulemaking.
ADDRESSES: Submit comments in
response to FMR Case 2021–02 to:
Regulations.gov: https://
www.regulations.gov. Submit comments
via the Federal eRulemaking portal by
searching for ‘‘FMR Case 2021–02.’’
Select the link ‘‘Comment Now’’ that
corresponds with FMR Case 2021–02.
Follow the instructions provided at the
‘‘Comment Now’’ screen. Please include
your name, company name (if any), and
‘‘FMR Case 2021–02’’ on your attached
document. If your comment cannot be
submitted using https://
www.regulations.gov, call or email the
points of contact in the FOR FURTHER
INFORMATION CONTACT section of this
document for alternative instructions.
Instructions: Please submit comments
only and cite FMR Case 2021–02 in all
correspondence related to this case.
Comments received generally will be
posted without change to https://
www.regulations.gov, including any
personal or business confidential
information, or both, provided. To
confirm receipt of your comment(s),
please check www.regulations.gov
approximately two to three days after
submission to verify posting.
FOR FURTHER INFORMATION CONTACT: For
clarification of content, contact Mr.
Chris Coneeney, Director, Real Property
Policy Division, Office of Governmentwide Policy, at 202–208–2956 or
chris.coneeney@gsa.gov. For
information pertaining to status or
publication schedules, contact the
Regulatory Secretariat Division at 202–
501–4755 or GSARegSec@gsa.gov.
Please cite FMR Case 2021–02.
SUPPLEMENTARY INFORMATION:
I. History of the Program
Art in U.S. public buildings has a long
history, beginning in the 1850s in the
U.S. Custom House in New Orleans and
continuing at the U.S. Capitol and
through the Beaux-Arts era when
courthouses and custom houses
throughout the Nation were embellished
with works of art. In the 1930s, the
Great Depression saw the creation of
relief programs of the New Deal,
including four art programs: The Public
Works of Art, which employed artists to
create artworks; the Section of Fine Arts
(the Section), a Treasury Department
effort that awarded commissions to
artists through competitions to secure
the best quality artwork for installation
in public buildings, including Federal
buildings, courthouses and post offices;
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Agencies
[Federal Register Volume 87, Number 22 (Wednesday, February 2, 2022)]
[Rules and Regulations]
[Pages 5709-5711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02099]
[[Page 5709]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0139; FRL-9253-01-OCSPP]
Saccharomyces cerevisiae Strain LAS02; Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Saccharomyces cerevisiae strain LAS02 in
or on all food commodities when used in accordance with label
directions and good agricultural practices. Lesaffre Yeast Corporation
(c/o Wagner Regulatory Associates, Inc.) submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of Saccharomyces cerevisiae strain LAS02 under FFDCA when used
in accordance with this exemption.
DATES: This regulation is effective February 2, 2022. Objections and
requests for hearings must be received on or before April 4, 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-2021-0139, 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 (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: 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:
[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 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(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-2021-0139 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
April 4, 2022. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b), although EPA
strongly encourages those interested in submitting objections or a
hearing request, to submit objections and hearing requests
electronically. See Order Urging Electronic Service and Filing (April
10, 2020), https://www.epa.gov/sites/production/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.
At this time, because of the COVID-19 pandemic, the judges and staff of
the Office of Administrative Law Judges are working remotely and not
able to accept filings or correspondence by courier, personal delivery,
or commercial delivery, and the ability to receive filings or
correspondence by U.S. Mail is similarly limited. When submitting
documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a
person should utilize the OALJ e-filing system, at https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf.
Although EPA's regulations require submission via U.S. Mail or hand
delivery, EPA intends to treat submissions filed via electronic means
as properly filed submissions during this time that the Agency
continues to maximize telework due to the pandemic; therefore, EPA
believes the preference for submission via electronic means will not be
prejudicial. If it is impossible for a person to submit documents
electronically or receive service electronically, e.g., the person does
not have any access to a computer, the person shall so advise OALJ by
contacting the Hearing Clerk at (202) 564-6281. If a person is without
access to a computer and must file documents by U.S. Mail, the person
shall notify the Hearing Clerk every time it files a document in such a
manner. The address for mailing documents is U.S. Environmental
Protection Agency, Office of Administrative Law Judges, Mail Code
1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
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-2021-0139 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 5710]]
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/where-send-comments-epa-dockets.
II. Background
In the Federal Register of September 22, 2021 (86 FR 52624) (FRL-
8792-03), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
exemption petition (PP 0F8841) by Lesaffre Yeast Corporation (c/o
Wagner Regulatory Associates, Inc.,) P.O. Box 640, 7217 Lancaster Pike,
Suite A, Hockessin, DE 19707. The petition requested that 40 CFR part
180 be amended by establishing an exemption from the requirement of a
tolerance for residues of the bactericide and fungicide Saccharomyces
cerevisiae strain LAS02 in or on all food commodities. That notice
referenced a summary of the petition prepared by the petitioner
Lesaffre Yeast Corporation and available in the docket via https://www.regulations.gov. No comments were received on the 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
Saccharomyces cerevisiae strain LAS02 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 and its risk assessment based on those data can be found
within the document entitled ``Human Health Risk Assessment of the New
Active Ingredient Saccharomyces cerevisiae strain LAS02 in the Proposed
End-use Product EPA File Symbol 91810-G with an Associated Tolerance
Exemption Petition'' (Saccharomyces cerevisiae strain LAS02 Human
Health Assessment). This document, as well as other relevant
information, is available in the docket for this action as described
under ADDRESSES.
The available data and rationale supported by existing scientific
literature on Saccharomyces cerevisiae strain LAS02 and related
Saccharomyces cerevisiae species demonstrate that, with regard to
humans, Saccharomyces cerevisiae strain LAS02 is not toxic, pathogenic,
or infective via any reasonably foreseeable route of exposure. Humans,
including infants and children, are naturally exposed to Saccharomyces
cerevisiae as this microorganism is commonly found in many habitats
including soil, water, and plant surfaces. Furthermore, humans,
including infants and children, have a long history of safe dietary
exposure to strains of Saccharomyces cerevisiae through their use in
food production, nutritional supplements, and bio-therapeutics.
Saccharomyces cerevisiae strain LAS02 is expected to be non-toxic, non-
pathogenic, and non-infective based on its genetic similarity to other
food-use Saccharomyces cerevisiae strains and its lack of genetic
modification.
Although there may be some dietary and non-occupational exposures
to pesticide residues of Saccharomyces cerevisiae strain LAS02 when
used in accordance with label directions and good agricultural
practices, there is not a concern due to the lack of potential for
adverse effects. Humans have a long history of dietary exposure of
Saccharomyces cerevisiae through its use in food and supplement
products and natural exposure through its presence in the environment
with no reported significant adverse effects attributable to dietary or
non-occupational exposure based on the proposed pesticide uses. Because
there are no threshold levels of concern with the toxicity,
pathogenicity, or infectivity of Saccharomyces cerevisiae strain LAS02,
EPA determined that no additional margin of safety is necessary to
protect infants and children as part of the qualitative assessment
conducted. Based upon its evaluation in the Saccharomyces cerevisiae
strain LAS02 Human Health Assessment, which concludes that there are no
risks of concern from aggregate exposure to Saccharomyces cerevisiae
strain LAS02, 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 Saccharomyces
cerevisiae strain LAS02.
B. Analytical Enforcement Methodology
An analytical method is not required for Saccharomyces cerevisiae
strain LAS02 because EPA is establishing an exemption from the
requirement of a tolerance without any numerical limitation.
C. Conclusion
Therefore, an exemption from the requirement of a tolerance is
established for residues of Saccharomyces cerevisiae strain LAS02 in or
on all food commodities when used in accordance with label directions
and good agricultural practices.
IV. Statutory and Executive Order Reviews
This action establishes a tolerance exemption 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). 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
[[Page 5711]]
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
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 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, EPA 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 (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).
V. 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 14, 2022.
Edward Messina,
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
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. Add Sec. 180.1391 to subpart D to read as follows:
Sec. 180.1391 Saccharomyces cerevisiae strain LAS02; exemption from
the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Saccharomyces cerevisiae strain LAS02 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.
[FR Doc. 2022-02099 Filed 2-1-22; 8:45 am]
BILLING CODE 6560-50-P