Rule2022-18012
Streptomyces sp. Strain K61; Exemption From the Requirement of a Tolerance
Primary source
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Published
August 24, 2022
Effective
August 24, 2022
Issuing agencies
Environmental Protection Agency
Abstract
This regulation amends the existing exemption from the requirement of a tolerance for residues of Streptomyces sp. strain K61 in or on all raw agricultural commodities when used as a fungicide for the treatment of seeds, cuttings, transplants, and plants of agricultural crops in accordance with good agricultural practices by removing the fungicidal use stipulation and clarifying that the exemption covers use in or on all food commodities when used in accordance with label directions and good agricultural practices. Danstar Ferment Ag/LALLEMAND PLANT CARE, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting that EPA amend the existing tolerance exemption for Streptomyces sp. strain K61. This regulation eliminates the need to establish a maximum permissible level for residues of Streptomyces sp. strain K61 under FFDCA.
Full Text
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<title>Federal Register, Volume 87 Issue 163 (Wednesday, August 24, 2022)</title>
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[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Rules and Regulations]
[Pages 51911-51915]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18012]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0273; FRL-9963-01-OCSPP]
Streptomyces sp. Strain K61; Exemption From the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation amends the existing exemption from the
requirement of a tolerance for residues
[[Page 51912]]
of Streptomyces sp. strain K61 in or on all raw agricultural
commodities when used as a fungicide for the treatment of seeds,
cuttings, transplants, and plants of agricultural crops in accordance
with good agricultural practices by removing the fungicidal use
stipulation and clarifying that the exemption covers use in or on all
food commodities when used in accordance with label directions and good
agricultural practices. Danstar Ferment Ag/LALLEMAND PLANT CARE,
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting that EPA amend the existing tolerance exemption
for Streptomyces sp. strain K61. This regulation eliminates the need to
establish a maximum permissible level for residues of Streptomyces sp.
strain K61 under FFDCA.
DATES: This regulation is effective August 24, 2022. Objections and
requests for hearings must be received on or before October 24, 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-2022-0273, 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 and the OPP Docket is (202) 566-1744. For the latest
status information on EPA/DC services, 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 (7511M), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (202) 566-1400; email address:
<a href="/cdn-cgi/l/email-protection#f9bba9a9bdbfabb7968d909a9c8ab99c8998d79e968f"><span class="__cf_email__" data-cfemail="82c0d2d2c6c4d0ccedf6ebe1e7f1c2e7f2e3ace5edf4">[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 Register's e-CFR site at
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.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-2022-0273 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
October 24, 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-2022-0273, 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>.
In the Federal Register of April 28, 2022 (87 FR 25178) (FRL-9410-
12-OCSPP), 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 1F8953) by Danstar Ferment Ag/LALLEMAND PLANT
CARE, Postsrasse 20, CH-6300 Zug, Switzerland (c/o Amy Plato Roberts,
P.O. Box 990, Hailey, ID 83333). The petition requested that 40
[[Page 51913]]
CFR part 180.1120 be amended by establishing an exemption from the
requirement of a tolerance for residues of Streptomyces sp. strain K61
in or on all food commodities. That notice referenced a summary of the
petition prepared by the petitioner Danstar Ferment Ag/LALLEMAND PLANT
CARE and is available in the docket via <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Two comments were received on the notice of filing. EPA's response to
these comments is discussed in Unit V.B.
III. Aggregate Risk Assessment and Determination of Safety
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 establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm to human health. If EPA is
able to determine that a tolerance is not necessary to ensure that
there is a reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemical residue, an exemption from the
requirement of a tolerance may be established. Consistent with FFDCA
section 408(c)(2)(A), and the factors specified in FFDCA section
408(c)(2)(B), EPA has reviewed the available scientific data and other
relevant information in support of this action. EPA has sufficient data
to assess the hazards of and to make a determination on aggregate
exposure for Streptomyces sp. strain K61 including exposure resulting
from the exemption established by this action. A full explanation of
the data upon which EPA relied and its risk assessment based on those
data can be found in the Streptomyces Strain K61 Registration Review
Final Decision available in docket EPA-HQ-OPP-2009-0509, Streptomyces
Strain K61 Biopesticides Registration Action Document available in
docket EPA-HQ-OPP-2009-0509, Review of Petition to Amend an Existing
Tolerance Exemption for Streptomyces sp. Strain K61 and in the document
entitled ``Risk Assessment for a FIFRA Section 3 Registration of
Streptomyces sp. Strain K61 Technical, Containing 100% of the Currently
Registered Active Ingredient Streptomyces sp. Strain K61'' (a.k.a.
Streptomyces sp. strain K61 Risk Assessment). Streptomyces sp. strain
K61 Risk Assessment, as well as other relevant information, is
available in the docket for this action as described under ADDRESSES.
A. Toxicological Profile
Streptomyces strain K61 is a naturally occurring microbe found in
soils throughout the world, and there are no known reports of any
deleterious effects associated with its consumption. Additionally, the
acute toxicity data on file with the Agency confirm its lack of acute
toxicity. There is also no evidence of adverse effects from oral
exposure to this microbial agent. Data on file with the Agency confirm
the lack of oral toxicity/pathogenicity of Streptomyces strain K61. For
the full discussion of the Toxicological Profile of Streptomyces sp.
strain K61, see the Streptomyces Strain K61 Registration Review Final
Decision and, the Streptomyces Strain K61 Biopesticides Registration
Action Document, both available in docket EPA-HQ-OPP-2009-0509.
B. Exposure Assessment
1. Dietary exposure from food, feed uses, and drinking water.
Streptomyces sp. strain K61 is found in soils throughout the world.
Dietary exposure to Streptomyces strain K61 is expected to be minimal.
As the mode of action of Streptomyces strain K61 is through root
colonization, the majority of applications are to seeds and soil.
Certain foliar applications are permitted for the purposes of
suppressing Botrytis infection and promoting growth; however, direct
applications to crops are highly diluted and residues are not expected
to persist.
Exposure to Streptomyces strain K61 via drinking water when the
pesticide is used is not likely to be greater than current/existing
exposures. Although Streptomyces strain K61 is found naturally, it does
not thrive in aquatic environments. There are no aquatic use sites for
the pesticide, so exposure in drinking water is not expected.
2. From non-dietary exposure. There are no residential uses for
Streptomyces strain K61. Non-occupational exposures are not expected;
in the event of accidental exposure, no non-occupational risks are
anticipated.
3. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance or
exemption, the Agency consider ``available information'' concerning the
cumulative effects of a particular pesticide's residues and ``other
substances that have a common mechanism of toxicity.'' EPA has not
found that Streptomyces sp. strain K61 shares a common mechanism of
toxicity with any other substances, and it does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed Streptomyces sp. strain
K61 does not have a common mechanism of toxicity with other substances.
For information regarding EPA's efforts to determine which chemicals
have a common mechanism of toxicity and to evaluate the cumulative
effects of such chemicals, see EPA's website at <a href="https://www.epa.gov/pesticides/cumulative">https://www.epa.gov/pesticides/cumulative</a>.
C. Safety Factor for Infants and Children
FFDCA Section 408(b)(2)(C) provides that EPA shall retain an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA safety factor (SF). In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor. Based on the
low toxicity of Streptomyces sp. strain K61 in the available studies,
EPA has concluded that there are no
[[Page 51914]]
toxicological endpoints of concern for the U.S. population, including
infants and children, and therefore conducted a qualitative assessment
of Streptomyces sp. strain K61. As part of its qualitative assessment,
the Agency did not use safety factors for assessing risk, and no
additional safety factor is needed for assessing risk to infants and
children.
D. Aggregate Risk
Based on the available data and information, the EPA has concluded
that a qualitative aggregate risk assessment is appropriate to support
the pesticidal use of Streptomyces sp. strain K61, and that risks of
concern are not anticipated from aggregate exposure to the substance.
This conclusion is based on the low toxicity of the active ingredient.
A full explanation of why the Agency is relying on prior 2011
Streptomyces sp. strain K61 registration review risk assessments for
addressing the amendment to the exemption of a tolerance can be found
within the Review of Petition to Amend an Existing Tolerance Exemption
for Streptomyces sp. Strain K61 document. This document, as well as
other relevant information, are available in the docket for this action
as described under ADDRESSES.
IV. Determination of Safety for U.S. Population, Infants and Children
Based on the Agency's assessment, EPA concludes that there is
reasonable certainty that no harm will result to the U.S. population,
including infants and children, from aggregate exposure to residues of
Streptomyces sp. strain K61.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for Streptomyces sp. strain
K61 because EPA is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. Response to Comments
One comment was received in response to the notice of filing. The
comment discusses potential risk to humans and nontarget organisms from
the use of products containing this active ingredient. Consistent with
FFDCA section 408(b)(2)(D), EPA reviews the available scientific data
and other relevant information and considers their validity,
completeness, and reliability, as well as the relationship of this
information to human risk. EPA also considers available information
concerning the variability of the sensitivities of major identifiable
subgroups of consumers, including infants and children. EPA relied on a
variety of data and information to conclude 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
Streptomyces sp. strain K61.
VI. Conclusions
Therefore, the existing tolerance exemption for Streptomyces sp.
strain K61 is amended by establishing an exemption from the requirement
of a tolerance for residues of Streptomyces sp. strain K61 in or on all
food commodities when used in accordance with label directions and good
agricultural practices.
VII. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance 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).
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).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 12, 2022.
Charles Smith,
Director, Biopesticides and Pollution Prevention Division.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Revise Sec. 180.1120 to read as follows:
[[Page 51915]]
Sec. 180.1120 Streptomyces sp. strain K61; exemption from the
requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Streptomyces sp. strain K61 in or on all food commodities
when used in accordance with label directions and good agricultural
practices.
[FR Doc. 2022-18012 Filed 8-23-22; 8:45 am]
BILLING CODE 6560-50-P
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