[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 [www.gpo.gov]
[FR Doc No: 2024-15376]


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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.

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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 
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 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 https://www.epa.gov/dockets.

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: 
[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-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 https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf. 
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 https://yosemite.epa.gov/OA/EAB/EAC-ALJ_upload.nsf.
    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:
     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://

[[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 https://www.epa.gov/dockets.

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 https://www.regulations.gov. 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