Kosakonia cowanii strain SYM00028; Exemption From the Requirement of a Tolerance, 70980-70982 [2021-26846]
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70980
Federal Register / Vol. 86, No. 237 / Tuesday, December 14, 2021 / Rules and Regulations
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: December 6, 2021.
Edward Messina,
Director, Office of Pesticide Programs.
jspears on DSK121TN23PROD with RULES1
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.
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2. Add § 180.1390 to subpart D to read
as follows:
■
§ 180.1390 Trichoderma harzianum strain
T-78; exemption from the requirement of a
tolerance.
An exemption from the requirement
of a tolerance is established for residues
of Trichoderma harzianum strain T-78
in or on all food commodities when
used in accordance with label directions
and good agricultural practices.
[FR Doc. 2021–26844 Filed 12–13–21; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2020–0577; FRL–9216–01–
OCSPP]
Kosakonia cowanii strain SYM00028;
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of Kosakonia
cowanii strain SYM00028 in or on all
food commodities when used in
accordance with label directions and
good agricultural practices. Indigo Ag,
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 Kosakonia cowanii strain
SYM00028 under FFDCA when used in
accordance with this exemption.
DATES: This regulation is effective
December 14, 2021. Objections and
requests for hearings must be received
on or before February 14, 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–2020–0577, 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
SUMMARY:
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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 are
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:
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 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–2020–0577 in the subject line on
the first page of your submission. All
objections and requests for a hearing
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Federal Register / Vol. 86, No. 237 / Tuesday, December 14, 2021 / Rules and Regulations
must be in writing and must be received
by the Hearing Clerk on or before
February 14, 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–
2020–0577, by one of the following
methods:
VerDate Sep<11>2014
16:20 Dec 13, 2021
Jkt 256001
• 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-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.
II. Background
In the Federal Register of February
24, 2021 (86 FR 11215) (FRL–10019–68),
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
0F8845) by Indigo Ag, Inc., 500
Rutherford Ave., Ste. 201, Boston, MA
02129. The petition requested that 40
CFR part 180 be amended by
establishing an exemption from the
requirement of a tolerance for residues
of the fungicide Kosakonia cowanii
strain SYM00028 in or on all food
commodities. That notice referenced a
summary of the petition prepared by the
petitioner Indigo Ag, Inc., 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
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70981
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
Kosakonia cowanii strain SYM00028
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
‘‘Product Chemistry Review and Human
Health Risk Assessment for the Section
3 Registration Submitted by Indigo Ag
Inc., (EP Indigo 229 FP/WD) Containing
the New Active Ingredient Kosakonia
cowanii strain SYM00028’’ (Kosakonia
cowanii strain SYM00028 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 demonstrated that,
with regard to humans, Kosakonia
cowanii strain SYM00028 is not toxic
via the pulmonary (LC50 > 5.21 mg/L),
oral (LD50 > 5,000 mg/kg bodyweight),
or dermal (LD50 > 5,050 mg/kg
bodyweight) routes of exposure; is not
toxic, pathogenic, or infective via the
injection route of exposure when
administered intravenously at a nominal
dose of 2.43 × 107 colony-forming units
per test animal; is not anticipated to be
pathogenic or infective via the oral or
pulmonary routes of exposure; and is
slightly irritating via the dermal route of
exposure. Additionally, the acute
injection toxicity/pathogenicity study
demonstrated a pattern of clearance of
Kosakonia cowanii strain SYM00028
from the blood and organs of the test
animals. Significant dietary and nonoccupational exposures to residues of
Kosakonia cowanii strain SYM00028 are
not anticipated because it will be used
only as a seed treatment and it is not
expected to remain at high levels on
plant surfaces or readily percolate
through soil. Even if dietary and nonoccupational exposures to residues of
Kosakonia cowanii strain SYM00028
were to occur, there is not a concern due
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Federal Register / Vol. 86, No. 237 / Tuesday, December 14, 2021 / Rules and Regulations
to the lack of potential for adverse
effects. Because there are no threshold
levels of concern with the toxicity,
pathogenicity, or infectivity of
Kosakonia cowanii strain SYM00028,
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 Kosakonia
cowanii strain SYM00028 Human
Health Assessment, which concludes
that there are no risks of concern from
aggregate exposure to Kosakonia
cowanii strain SYM00028, 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 Kosakonia cowanii strain
SYM00028.
B. Analytical Enforcement Methodology
An analytical method is not required
for Kosakonia cowanii strain SYM00028
because EPA is establishing an
exemption from the requirement of a
tolerance without any numerical
limitation.
jspears on DSK121TN23PROD with RULES1
C. Conclusion
Therefore, an exemption from the
requirement of a tolerance is established
for residues of Kosakonia cowanii strain
SYM00028 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
Order 12898, entitled ‘‘Federal Actions
to Address Environmental Justice in
Minority Populations and Low-Income
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16:20 Dec 13, 2021
Jkt 256001
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.
PO 00000
Frm 00038
Fmt 4700
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Dated: December 6, 2021.
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 § 180.1387 to subpart D to read
as follows:
■
§ 180.1387 Kosakonia cowanii strain
SYM00028; exemption from the requirement
of a tolerance.
An exemption from the requirement
of a tolerance is established for residues
of Kosakonia cowanii strain SYM00028
in or on all food commodities when
used in accordance with label directions
and good agricultural practices.
[FR Doc. 2021–26846 Filed 12–13–21; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 413 and 512
[CMS–1749–CN]
RIN 0938–AU39
Medicare Program; End-Stage Renal
Disease Prospective Payment System,
Payment for Renal Dialysis Services
Furnished to Individuals With Acute
Kidney Injury, End-Stage Renal
Disease Quality Incentive Program,
and End-Stage Renal Disease
Treatment Choices Model; Correction
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule; correction.
AGENCY:
This document corrects a
typographic error that appeared in the
final rule published in the Federal
Register on November 8, 2021 entitled
‘‘Medicare Program; End-Stage Renal
Disease Prospective Payment System,
Payment for Renal Dialysis Services
Furnished to Individuals With Acute
Kidney Injury, End-Stage Renal Disease
Quality Incentive Program, and EndStage Renal Disease Treatment Choices
Model.’’
DATES: This correction is effective
January 1, 2022.
SUMMARY:
E:\FR\FM\14DER1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 237 (Tuesday, December 14, 2021)]
[Rules and Regulations]
[Pages 70980-70982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26846]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0577; FRL-9216-01-OCSPP]
Kosakonia cowanii strain SYM00028; 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 Kosakonia cowanii strain SYM00028 in or
on all food commodities when used in accordance with label directions
and good agricultural practices. Indigo Ag, 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 Kosakonia cowanii strain SYM00028 under FFDCA when used
in accordance with this exemption.
DATES: This regulation is effective December 14, 2021. Objections and
requests for hearings must be received on or before February 14, 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-2020-0577, 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 are 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-2020-0577 in the subject line on the first
page of your submission. All objections and requests for a hearing
[[Page 70981]]
must be in writing and must be received by the Hearing Clerk on or
before February 14, 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-2020-0577, 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 dockets generally, is available at https://www.epa.gov/dockets.
II. Background
In the Federal Register of February 24, 2021 (86 FR 11215) (FRL-
10019-68), 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 0F8845) by Indigo Ag, Inc., 500 Rutherford Ave.,
Ste. 201, Boston, MA 02129. The petition requested that 40 CFR part 180
be amended by establishing an exemption from the requirement of a
tolerance for residues of the fungicide Kosakonia cowanii strain
SYM00028 in or on all food commodities. That notice referenced a
summary of the petition prepared by the petitioner Indigo Ag, Inc., 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
Kosakonia cowanii strain SYM00028 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 ``Product Chemistry Review and Human
Health Risk Assessment for the Section 3 Registration Submitted by
Indigo Ag Inc., (EP Indigo 229 FP/WD) Containing the New Active
Ingredient Kosakonia cowanii strain SYM00028'' (Kosakonia cowanii
strain SYM00028 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 demonstrated that, with regard to humans,
Kosakonia cowanii strain SYM00028 is not toxic via the pulmonary
(LC50 > 5.21 mg/L), oral (LD50 > 5,000 mg/kg
bodyweight), or dermal (LD50 > 5,050 mg/kg bodyweight)
routes of exposure; is not toxic, pathogenic, or infective via the
injection route of exposure when administered intravenously at a
nominal dose of 2.43 x 10\7\ colony-forming units per test animal; is
not anticipated to be pathogenic or infective via the oral or pulmonary
routes of exposure; and is slightly irritating via the dermal route of
exposure. Additionally, the acute injection toxicity/pathogenicity
study demonstrated a pattern of clearance of Kosakonia cowanii strain
SYM00028 from the blood and organs of the test animals. Significant
dietary and non-occupational exposures to residues of Kosakonia cowanii
strain SYM00028 are not anticipated because it will be used only as a
seed treatment and it is not expected to remain at high levels on plant
surfaces or readily percolate through soil. Even if dietary and non-
occupational exposures to residues of Kosakonia cowanii strain SYM00028
were to occur, there is not a concern due
[[Page 70982]]
to the lack of potential for adverse effects. Because there are no
threshold levels of concern with the toxicity, pathogenicity, or
infectivity of Kosakonia cowanii strain SYM00028, 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 Kosakonia cowanii strain SYM00028 Human Health
Assessment, which concludes that there are no risks of concern from
aggregate exposure to Kosakonia cowanii strain SYM00028, 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 Kosakonia cowanii strain SYM00028.
B. Analytical Enforcement Methodology
An analytical method is not required for Kosakonia cowanii strain
SYM00028 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 Kosakonia cowanii strain SYM00028 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 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: December 6, 2021.
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. 180.1387 to subpart D to read as follows:
Sec. 180.1387 Kosakonia cowanii strain SYM00028; exemption from the
requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Kosakonia cowanii strain SYM00028 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.
[FR Doc. 2021-26846 Filed 12-13-21; 8:45 am]
BILLING CODE 6560-50-P
