Document ID: EPA-HQ-OPP-2022-0273-0005
Agency: epa
Document Type: Rule
Title: Amendment to an Exemption from the Requirement of a Tolerance: Streptomyces sp. strain K61
Posted Date: 2022-08-24T04:00Z

[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 [www.gpo.gov]
[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 
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 and the OPP Docket is (202) 566-1744. For the latest 
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Office of the Federal Register's e-CFR site at 
https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-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), 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-2022-0273, 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.
    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 https://www.regulations.gov. 
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 https://www.epa.gov/pesticides/cumulative.

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