Rule2021-24794
Methylorubrum populi Strain NLS0089; Exemption From the Requirement of a Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 15, 2021
Effective
November 15, 2021
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 217 (Monday, November 15, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#450715150103170b2a312c262036052035246b222a33"><span class="__cf_email__" data-cfemail="0d4f5d5d494b5f436279646e687e4d687d6c236a627b">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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 <a href="https://ecfr.federalregister.gov/current/title-40">https://ecfr.federalregister.gov/current/title-40</a>.
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), <a href="https://www.epa.gov/sites/production/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf">https://www.epa.gov/sites/production/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf</a>.
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 <a href="https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf">https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf</a>.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
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