Rule2024-15376
Gluconobacter cerinus Strain BC18B and Hanseniaspora uvarum Strain BC18Y; Exemptions 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
July 16, 2024
Effective
July 16, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes exemptions from the requirement of a tolerance for residues of Gluconobacter cerinus strain BC18B and Hanseniaspora uvarum strain BC18Y in or on all food commodities when used in accordance with label directions and good agricultural practices. Danisco US Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting exemptions from the requirement of a tolerance. This regulation eliminates the need to establish maximum permissible levels for residues of Gluconobacter cerinus strain BC18B and Hanseniaspora uvarum strain BC18Y when used in accordance with this exemption.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 136 (Tuesday, July 16, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 136 (Tuesday, July 16, 2024)]
[Rules and Regulations]
[Pages 57773-57775]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-15376]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0008; FRL-10898-01-OCSPP]
Gluconobacter cerinus Strain BC18B and Hanseniaspora uvarum
Strain BC18Y; Exemptions From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of Gluconobacter cerinus strain BC18B and
Hanseniaspora uvarum strain BC18Y in or on all food commodities when
used in accordance with label directions and good agricultural
practices. Danisco US Inc. submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting exemptions
from the requirement of a tolerance. This regulation eliminates the
need to establish maximum permissible levels for residues of
Gluconobacter cerinus strain BC18B and Hanseniaspora uvarum strain
BC18Y when used in accordance with this exemption.
DATES: This regulation is effective July 16, 2024. Objections and
requests for hearings must be received on or before September 16, 2024
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-2023-0008, 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 20004. 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 OPP Docket is (202) 566-1744. Please review the
visitor instructions and additional information about the docket
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Madison H. Le, 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#89cbd9d9cdcfdbc7e6fde0eaecfac9ecf9e8a7eee6ff"><span class="__cf_email__" data-cfemail="c98b99998d8f9b87a6bda0aaacba89acb9a8e7aea6bf">[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-2023-0008 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
September 16, 2024. EPA's Office of Administrative Law Judges (OALJ),
in which the Hearing Clerk is housed, urges parties to file and serve
documents by electronic means only, notwithstanding any other
particular requirements set forth in other procedural rules governing
those proceedings. See ``Revised Order Urging Electronic Service and
Filing'', dated June 22, 2023, which can be found at <a href="https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf">https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf</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; therefore, EPA believes the preference
for submission via electronic means will not be prejudicial. When
submitting documents to the OALJ electronically, a person should
utilize the OALJ e-filing system at <a href="https://yosemite.epa.gov/OA/EAB/EAC-ALJ_upload.nsf">https://yosemite.epa.gov/OA/EAB/EAC-ALJ_upload.nsf</a>.
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-2023-0008, 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 https://
[[Page 57774]]
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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Background
In the Federal Register of March 24, 2023 (88 FR 17780) (FRL-10579-
02), 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 1F8927) by Danisco US Inc., 925 Page Mill Road, Palo Alto,
CA 94304. The petition requested that 40 CFR part 180 be amended by
establishing exemptions from the requirement of a tolerance for
residues of the microbial pesticides Gluconobacter cerinus strain BC18B
and Hanseniaspora uvarum strain BC18Y in or on all food commodities
(although not expressly stated in the petition, EPA interpreted the
petition as requesting an exemption covering all food commodities).
That notice referenced a summary of the petition prepared by the
petitioner Danisco US Inc. which is available in the docket via <a href="https://www.regulations.gov">https://www.regulations.gov</a>. EPA received no comments in response to the
notice of filing.
EPA revised the tolerance exemption expression to specifically
include the establishment of exemptions from the requirement of a
tolerance for residues of the microbial pesticides Gluconobacter
cerinus strain BC18B and Hanseniaspora uvarum strain BC18Y in or on all
food commodities. The reason for this change is explained in Unit
III.C.
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
Gluconobacter cerinus strain BC18B and Hanseniaspora uvarum strain
BC18Y 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 ``Human
Health Risk Assessment of Gluconobacter cerinus strain BC18B and
Hanseniaspora uvarum strain BC18Y, New Active Ingredients, in BC18-C
(Manufacturing-use Product) and BC18-WG (End-use Product) Proposed for
Registration with Associated Petitions Requesting Tolerance
Exemptions'' (Human Health Risk Assessment of Gluconobacter cerinus
strain BC18B and Hanseniaspora uvarum strain BC18Y). This document, as
well as other relevant information, is available in the docket for this
action as described under ADDRESSES.
Based upon its evaluation, EPA concludes that Gluconobacter cerinus
strain BC18B and Hanseniaspora uvarum strain BC18Y were not found to be
toxic, pathogenic, or infective in the present acute oral toxicity/
pathogenicity studies. Additionally, all presented studies demonstrated
a pattern of clearance of Gluconobacter cerinus strain BC18B and
Hanseniaspora uvarum strain BC18Y from the organs of test animals.
Based on lack of adverse effects seen in the available toxicity/
pathogenicity data, EPA does not expect any dietary exposure, drinking
water exposure, non-occupational and residential exposures resulting
from the use of these microbial pesticides to pose any quantifiable
risk. Additionally, Hanseniaspora uvarum and Gluconobacter cerinus
naturally occur on fruits, vegetables, and a variety of plant-based
foods. Therefore, while products containing that Gluconobacter cerinus
strain BC18B and Hanseniaspora uvarum strain BC18Y are intended for
application to agricultural commodities, and exposure may occur through
consumption of foods, exposure is not expected to be above the levels
at which humans are naturally exposed.
Based upon its evaluation in the Human Health Risk Assessment of
Gluconobacter cerinus strain BC18B and Hanseniaspora uvarum strain
BC18Y, which concludes that there are no risks of concern from
aggregate exposure to Gluconobacter cerinus strain BC18B and
Hanseniaspora uvarum strain BC18Y, 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
Gluconobacter cerinus strain BC18B and Hanseniaspora uvarum strain
BC18Y. Therefore, exemptions from the requirement of tolerances are
established for residues of Gluconobacter cerinus strain BC18B and
Hanseniaspora uvarum strain BC18Y in or on all food commodities when
used in accordance with label directions and good agricultural
practices.
B. Analytical Enforcement Methodology
Analytical methods are not required for Gluconobacter cerinus
strain BC18B or Hanseniaspora uvarum strain BC18Y because EPA is
establishing exemptions from the requirement of a tolerance without any
numerical limitation.
C. Revisions to the Requested Tolerance Exemption
EPA revised the tolerance exemption expression to specifically
include the establishment of the exemptions from the requirement of a
tolerance for residues of the microbial pesticides Gluconobacter
cerinus strain BC18B and Hanseniaspora uvarum strain BC18Y in or on all
food commodities. Although not expressly stated in the petition, EPA
interpreted the petition as requesting an exemption covering all food
commodities.
D. Conclusion
Therefore, exemptions from the requirement of tolerances are
established for residues of Gluconobacter cerinus strain BC18B and
Hanseniaspora uvarum strain BC18Y 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
[[Page 57775]]
of actions from review under Executive Order 12866, entitled
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993).
Because this action has been exempted from review under Executive Order
12866, this action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), or
Executive Order 13045, entitled ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et
seq., nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance
exemption in this action, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601
et seq.) do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, EPA has determined that this
action will not have a substantial direct effect on States or Tribal
Governments, on the relationship between the National Government and
the States or Tribal Governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian Tribes. Thus, EPA has determined that
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10,
1999), and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), do not apply to this action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (2 U.S.C.
1501 et seq.).
This action does not involve any technical standards that would
require EPA's consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (15 U.S.C. 272 note).
V. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 17, 2024.
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. 180.1407 to subpart D to read as follows:
Sec. 180.1407 Gluconobacter cerinus strain BC18B and Hanseniaspora
uvarum strain BC18Y; exemptions from the requirement of a tolerance.
Exemptions from the requirement of tolerances are established for
residues of Gluconobacter cerinus strain BC18B and Hanseniaspora uvarum
strain BC18Y in or on all food commodities when used in accordance with
label directions and good agricultural practices.
[FR Doc. 2024-15376 Filed 7-15-24; 8:45 am]
BILLING CODE 6560-50-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on July 16, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.