Methylorubrum populi Strain NLS0089; Exemption From the Requirement of a Tolerance, 62925-62928 [2021-24794]
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Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Rules and Regulations
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or Tribal Governments, on the
relationship between the National
Government and the States or Tribal
Governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
Tribes. Thus, the Agency has
determined that Executive Order 13132,
entitled ‘‘Federalism’’ (64 FR 43255,
August 10, 1999) and Executive Order
13175, entitled ‘‘Consultation and
Coordination with Indian Tribal
Governments’’ (65 FR 67249, November
9, 2000) do not apply to this action. In
addition, this action does not impose
any enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et
seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
■
VIII. 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).
40 CFR Part 180
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
SUMMARY:
Dated: November 5, 2021.
Catherine Aubee,
Acting Director, Registration Division, Office
of Pesticide Programs.
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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. In § 180.510, designate the table in
paragraph (a)(1) as ‘‘Table 1 to
Paragraph (a)(1) and amend it by adding
in alphabetical order the following
commodities ‘‘Egg’’; ‘‘Poultry, fat’’;
‘‘Poultry, meat’’; and ‘‘Poultry, meat
byproducts’’ to read as follows:
§ 180.510 Pyriproxyfen; tolerances for
residues.
(a) * * *
(1) * * *
TABLE 1 TO PARAGRAPH (a)(1)
Parts per
million
Commodity
*
*
*
Egg .......................................
*
*
*
*
Poultry, fat ............................
Poultry, meat ........................
Poultry, meat byproducts ......
*
*
*
*
*
*
*
*
*
0.1
*
0.1
0.1
0.1
*
*
*
[FR Doc. 2021–24793 Filed 11–12–21; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2020–0481; FRL–8918–01–
OCSPP]
Methylorubrum populi Strain NLS0089;
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 Methylorubrum
populi strain NLS0089 in or on all food
commodities when used in accordance
with label directions and good
agricultural practices. NewLeaf
Symbiotics 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
Methylorubrum populi strain NLS0089
under FFDCA when used in accordance
with this exemption.
DATES: This regulation is effective
November 15, 2021. Objections and
requests for hearings must be received
on or before January 14, 2022 and must
be filed in accordance with the
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62925
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–2020–0481, 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 Public 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
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Register’s e-CFR site at https://
ecfr.federalregister.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–2020–0481 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
January 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.
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16:01 Nov 12, 2021
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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–
2020–0481, 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-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 March 22,
2021 (86 FR 15162) (FRL–10021–44),
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
0F8823) by NewLeaf Symbiotics, 1005
North Warson Rd., Ste. 102, St. Louis,
MO 63132. 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 Methylorubrum populi
strain NLS0089 in or on all food
commodities. That notice referenced a
summary of the petition prepared by the
petitioner NewLeaf Symbiotics 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
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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
Methylorubrum populi strain NLS0089
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
‘‘Revised Human Health Risk
Assessment of Methylorubrum populi
strain NLS0089, a New Active
Ingredient, in TS601, a new End-Use
Product Proposed for Registration, and
an Associated Petition Requesting a
Tolerance Exemption’’ (Methylorubrum
populi strain NLS0089 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, Methylorubrum
populi strain NLS0089 is not anticipated
to be toxic, pathogenic, or infective via
any reasonably foreseeable route of
exposure.
In an acute pulmonary toxicity/
pathogenicity study, four test animals
(one male rat and three female rats)
treated with Methylorubrum populi
strain NLS0089 died on days 2 or 3.
Three of four of these test animals
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exhibited irregular respiration before
death, and, upon necropsy, were found
to have red mottled lungs and/or fluidfilled intestines. Further, several of the
surviving test animals treated with
Methylorubrum populi strain NLS0089
exhibited abnormal clinical signs
through day 4 (e.g., irregular respiration
or pale color) and/or had abnormal gross
findings upon necropsy up to day 23
(e.g., red mottled lungs and/or enlarged
lymph nodes). Body weight and body
weight gain were not adversely affected
by treatment, and no abnormal clinical
signs, mortalities, or gross necropsy
findings were seen in the control
animals (not treated or treated with
inactivated Methylorubrum populi
strain NLS0089). The abnormal clinical
observations, mortalities, and abnormal
necropsy findings are likely consistent
with and attributed to factors such as
anesthesia administration and test
substance administration, which was
higher than the recommended
maximum hazard dose, via the
intratracheal route. As a result, these
findings are likely attributed to a
combination of anesthesia effects and
overdosing, which are not indicative of
toxicity or relevant to pesticide
exposure concerns when used according
to label directions and good agricultural
practices. Overall, this study established
that Methylorubrum populi strain
NLS0089 is not pathogenic or infective
when administered intratracheally at a
single dose of 2.93 × 109 colony-forming
units (CFU) per test animal and
demonstrated a pattern of clearance of
Methylorubrum populi strain NLS0089
from the blood, cecum contents, and
organs of the test animals.
In an acute injection toxicity/
pathogenicity study, numerous test
animals treated with Methylorubrum
populi strain NLS0089 and one test
animal treated with inactivated
Methylorubrum populi strain NLS0089
had enlarged spleens upon necropsy up
to day 22. There were no adverse effects
of mortality, clinical signs, body weight,
or body weight gain in any of the test
groups. The abnormal necropsy findings
likely reflect a physiological response to
a blood-borne antigen rather than a toxic
effect on the spleen due to the spleen’s
function of filtering blood of infectious
agents. The assay was testing an
artificial infection and most likely
indicated lymphocytes producing
antibodies reacting to the infection,
which were filtered by the spleen
causing an enlargement. It should be
noted that signs of infection, i.e., the
spread of the microbial pest control
agents (MPCA) across the blood/brain
barrier or to other organs not involved
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with an immune response, were not
noted, and there were no other signs of
toxin production during exposure.
Overall, this study established that
Methylorubrum populi strain NLS0089
is not pathogenic or infective when
administered intravenously at a single
dose of 1.21 × 107 CFU per test animal
and demonstrated a pattern of clearance
of Methylorubrum populi strain
NLS0089 from the blood, cecum
contents, and organs of the test animals.
There may be some dietary and nonoccupational exposures to residues of
Methylorubrum populi strain NLS0089
when used in accordance with label
directions and good agricultural
practices, which exposures are only
slightly more than environmental
background levels for a short period of
time after application. However, there is
not a concern due to the lack of
potential for adverse effects. Because
there are no threshold levels of concern
with the toxicity, pathogenicity, or
infectivity of Methylorubrum populi
strain NLS0089, 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 Methylorubrum populi
strain NLS0089 Human Health
Assessment, which concludes that there
are no risks of concern from aggregate
exposure to Methylorubrum populi
strain NLS0089, 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
Methylorubrum populi strain NLS0089.
B. Analytical Enforcement Methodology
An analytical method is not required
for Methylorubrum populi strain
NLS0089 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 Methylorubrum populi
strain NLS0089 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
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62927
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).
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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
Dated: October 26, 2021.
Edward Messina,
Director, Office of Pesticide Programs.
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
2. Add § 180.1385 to subpart D to read
as follows:
■
§ 180.1385 Methylorubrum populi strain
NLS0089; exemption from the requirement
of a tolerance.
An exemption from the requirement
of a tolerance is established for residues
of Methylorubrum populi strain
NLS0089 in or on all food commodities
when used in accordance with label
directions and good agricultural
practices.
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Jkt 256001
42 CFR Parts 402, 403, 411, 412, 422,
423, 460, 483, 488, and 493
42 CFR Part 1003
Office of the Secretary
45 CFR Parts 79, 93, 102, 147, 150, 155,
156, 158, and 160
45 CFR Part 303
RIN 0991–AC0
Office of the Assistant
Secretary for Financial Resources,
Department of Health and Human
Services (HHS).
ACTION: Final rule.
AGENCY:
Authority: 21 U.S.C. 321(q), 346a and 371.
16:01 Nov 12, 2021
Centers for Medicare & Medicaid
Services
Adjustment of Civil Monetary Penalties
for Inflation and the Annual Civil
Monetary Penalties Inflation
Adjustment for 2021
■
VerDate Sep<11>2014
42 CFR Part 3
Administration for Children and
Families
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
BILLING CODE 6560–50–P
Office of the Secretary
Office of the Inspector General
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
[FR Doc. 2021–24794 Filed 11–12–21; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
This final rule finalizes the
provisions of the September 6, 2016
interim final rule that adjusts for
inflation the maximum civil monetary
penalty (CMP) amounts for all agencies
within the Department of Health and
Human Services (HHS) and updates
certain agency-specific regulations. It
also updates our required annual
inflation-related increases to the CMP
amounts in our regulations, under the
Federal Civil Penalties Inflation
Adjustment Act Improvements Act of
2015; adds references to new penalty
authorities; and reflects technical
changes to correct errors.
DATES:
Effective date: This final rule is
effective November 15, 2021.
Applicability date: The adjusted civil
monetary penalty amounts apply to
penalties assessed on or after November
15, 2021, if the violation occurred on or
after November 2, 2015.
FOR FURTHER INFORMATION CONTACT:
David Dasher, Deputy Assistant
Secretary, Office of Acquisitions, Office
of the Assistant Secretary for Financial
Resources, Room 536–H, Hubert
SUMMARY:
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Humphrey Building, 200 Independence
Avenue SW, Washington DC 20201;
202–205–0706.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Civil Penalties Inflation
Adjustment Act Improvements Act of
2015 (section 701 of Pub. L. 114–74)
(the ‘‘2015 Act’’) amended the Federal
Civil Penalties Inflation Adjustment Act
of 1990 (Pub. L. 101–410, 104 Stat. 890
(1990)), which is intended to improve
the effectiveness of civil monetary
penalties (CMPs) and to maintain the
deterrent effect of such penalties,
requires agencies to adjust the civil
monetary penalties for inflation
annually.
The Department of Health and Human
Services (HHS) lists the CMP authorities
and the amounts administered by all of
its agencies in tabular form in 45 CFR
102.3, which was issued in an interim
final rule published in the September 6,
2016, Federal Register (81 FR 61538).
Annual adjustments were subsequently
published on February 3, 2017 (82 FR
9175), October 11, 2018 (83 FR 51369),
November 5, 2019 (84 FR 59549), and
January 17, 2020 (85 FR 2869).
II. Provisions of the Final Rule
A. Finalization of the September 6, 2016
Interim Final Rule
In the September 6, 2016 Federal
Register (81 FR 61538), HHS issued a
department-wide interim final rule (IFR)
titled ‘‘Adjustment of Civil Monetary
Penalties for Inflation’’ that established
new regulations at 45 CFR part 102 to
adjust for inflation the maximum CMP
amounts for the various CMP authorities
for all agencies within the Department.
HHS took this action to comply with the
Federal Civil Penalties Inflation
Adjustment Act of 1990 (the Inflation
Adjustment Act) (28 U.S.C. 2461 note
2(a)), as amended by the Federal Civil
Penalties Inflation Adjustment Act
Improvements Act of 2015 (section 701
of the Bipartisan Budget Act of 2015,
(Pub. L.114–74), enacted on November
2, 2015). In addition, the September
2016 IFR included updates to certain
agency-specific regulations to reflect the
new provisions governing the
adjustment of civil monetary penalties
for inflation in 45 CFR part 102.
One of the purposes of the Inflation
Adjustment Act was to create a
mechanism to allow for regular
inflationary adjustments to federal civil
monetary penalties. Section 2(b)(1) of
the Inflation Adjustment Act. The 2015
amendments removed an inflation
update exclusion that previously
applied to the Social Security Act as
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]]>Agencies
[Federal Register Volume 86, Number 217 (Monday, November 15, 2021)]
[Rules and Regulations]
[Pages 62925-62928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24794]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0481; FRL-8918-01-OCSPP]
Methylorubrum populi Strain NLS0089; Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Methylorubrum populi strain NLS0089 in
or on all food commodities when used in accordance with label
directions and good agricultural practices. NewLeaf Symbiotics
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 Methylorubrum populi strain NLS0089
under FFDCA when used in accordance with this exemption.
DATES: This regulation is effective November 15, 2021. Objections and
requests for hearings must be received on or before January 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-2020-0481, 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 Public 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
[[Page 62926]]
Register's e-CFR site at https://ecfr.federalregister.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-2020-0481 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
January 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-2020-0481, 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 March 22, 2021 (86 FR 15162) (FRL-10021-
44), 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 0F8823) by NewLeaf Symbiotics, 1005 North Warson Rd., Ste.
102, St. Louis, MO 63132. 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 Methylorubrum populi strain
NLS0089 in or on all food commodities. That notice referenced a summary
of the petition prepared by the petitioner NewLeaf Symbiotics 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
Methylorubrum populi strain NLS0089 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 ``Revised Human Health Risk Assessment of
Methylorubrum populi strain NLS0089, a New Active Ingredient, in TS601,
a new End-Use Product Proposed for Registration, and an Associated
Petition Requesting a Tolerance Exemption'' (Methylorubrum populi
strain NLS0089 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,
Methylorubrum populi strain NLS0089 is not anticipated to be toxic,
pathogenic, or infective via any reasonably foreseeable route of
exposure.
In an acute pulmonary toxicity/pathogenicity study, four test
animals (one male rat and three female rats) treated with Methylorubrum
populi strain NLS0089 died on days 2 or 3. Three of four of these test
animals
[[Page 62927]]
exhibited irregular respiration before death, and, upon necropsy, were
found to have red mottled lungs and/or fluid-filled intestines.
Further, several of the surviving test animals treated with
Methylorubrum populi strain NLS0089 exhibited abnormal clinical signs
through day 4 (e.g., irregular respiration or pale color) and/or had
abnormal gross findings upon necropsy up to day 23 (e.g., red mottled
lungs and/or enlarged lymph nodes). Body weight and body weight gain
were not adversely affected by treatment, and no abnormal clinical
signs, mortalities, or gross necropsy findings were seen in the control
animals (not treated or treated with inactivated Methylorubrum populi
strain NLS0089). The abnormal clinical observations, mortalities, and
abnormal necropsy findings are likely consistent with and attributed to
factors such as anesthesia administration and test substance
administration, which was higher than the recommended maximum hazard
dose, via the intratracheal route. As a result, these findings are
likely attributed to a combination of anesthesia effects and
overdosing, which are not indicative of toxicity or relevant to
pesticide exposure concerns when used according to label directions and
good agricultural practices. Overall, this study established that
Methylorubrum populi strain NLS0089 is not pathogenic or infective when
administered intratracheally at a single dose of 2.93 x 10\9\ colony-
forming units (CFU) per test animal and demonstrated a pattern of
clearance of Methylorubrum populi strain NLS0089 from the blood, cecum
contents, and organs of the test animals.
In an acute injection toxicity/pathogenicity study, numerous test
animals treated with Methylorubrum populi strain NLS0089 and one test
animal treated with inactivated Methylorubrum populi strain NLS0089 had
enlarged spleens upon necropsy up to day 22. There were no adverse
effects of mortality, clinical signs, body weight, or body weight gain
in any of the test groups. The abnormal necropsy findings likely
reflect a physiological response to a blood-borne antigen rather than a
toxic effect on the spleen due to the spleen's function of filtering
blood of infectious agents. The assay was testing an artificial
infection and most likely indicated lymphocytes producing antibodies
reacting to the infection, which were filtered by the spleen causing an
enlargement. It should be noted that signs of infection, i.e., the
spread of the microbial pest control agents (MPCA) across the blood/
brain barrier or to other organs not involved with an immune response,
were not noted, and there were no other signs of toxin production
during exposure. Overall, this study established that Methylorubrum
populi strain NLS0089 is not pathogenic or infective when administered
intravenously at a single dose of 1.21 x 10\7\ CFU per test animal and
demonstrated a pattern of clearance of Methylorubrum populi strain
NLS0089 from the blood, cecum contents, and organs of the test animals.
There may be some dietary and non-occupational exposures to
residues of Methylorubrum populi strain NLS0089 when used in accordance
with label directions and good agricultural practices, which exposures
are only slightly more than environmental background levels for a short
period of time after application. However, there is not a concern due
to the lack of potential for adverse effects. Because there are no
threshold levels of concern with the toxicity, pathogenicity, or
infectivity of Methylorubrum populi strain NLS0089, 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 Methylorubrum populi strain NLS0089 Human Health
Assessment, which concludes that there are no risks of concern from
aggregate exposure to Methylorubrum populi strain NLS0089, 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 Methylorubrum populi strain NLS0089.
B. Analytical Enforcement Methodology
An analytical method is not required for Methylorubrum populi
strain NLS0089 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 Methylorubrum populi strain NLS0089 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).
[[Page 62928]]
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: October 26, 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. 180.1385 to subpart D to read as follows:
Sec. 180.1385 Methylorubrum populi strain NLS0089; exemption from the
requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Methylorubrum populi strain NLS0089 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.
[FR Doc. 2021-24794 Filed 11-12-21; 8:45 am]
BILLING CODE 6560-50-P
