[Federal Register Volume 85, Number 188 (Monday, September 28, 2020)]
[Rules and Regulations]
[Pages 60716-60718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20622]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0335; FRL-10013-27]


Pseudomonas fluorescens Strain ACK55; Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of Pseudomonas fluorescens strain ACK55 in 
or on all food commodities when used in accordance with label 
directions and good agricultural practices. The IR-4 Project 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

[[Page 60717]]

permissible level for residues of Pseudomonas fluorescens strain ACK55 
under FFDCA.

DATES: This regulation is effective September 28, 2020. Objections and 
requests for hearings must be received on or before November 27, 2020 
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-2017-0335, is available at 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the EPA 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 Reading Room is 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 https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Anne Overstreet, 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: 
BPPDFRNotices@epa.gov.

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 Government Publishing Office's e-CFR site at 
https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2017-0335 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 
November 27, 2020. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    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-2017-0335, 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/about-epa-dockets.

II. Background

    In the Federal Register of October 28, 2019 (84 FR 57685) (FRL-
10001-11), EPA issued a document pursuant to FFDCA section 408(d)(3), 
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
exemption petition (PP 9E8784) by the IR-4 Project, Rutgers, The State 
University of New Jersey, 500 College Rd. East, Suite 201W, Princeton, 
NJ 08540. The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of the herbicide Pseudomonas fluorescens strain ACK55 in or on 
all food commodities. That document referenced a summary of the 
petition prepared by the petitioner, the IR-4 Project, and is available 
in the docket via https://www.regulations.gov. There were no comments 
received in response to 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.''

[[Page 60718]]

    EPA evaluated the available toxicological and exposure data on 
Pseudomonas fluorescens strain ACK55 and considered their validity, 
completeness, and reliability, as well as the relationship of this 
information to human risk. An explanation of the data upon which EPA 
relied and its risk assessment based on those data can be found within 
the document entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) 
Safety Determination for Pseudomonas fluorescens strain ACK55.'' This 
document, as well as other relevant information, is available in the 
docket for this action as described under ADDRESSES. In sum, the 
available data indicate a lack of toxicity, infectivity, and 
pathogenicity from exposure to Pseudomonas fluorescens strain ACK55. 
Due primarily to the lack of any toxicity and adverse effects, 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 Pseudomonas fluorescens strain ACK55. 
Therefore, an exemption from the requirement of a tolerance is 
established for residues of Pseudomonas fluorescens strain ACK55 in or 
on all food commodities when used in accordance with label directions 
and good agricultural practices.

B. Analytical Enforcement Methodology

    An analytical method is not required because EPA is establishing an 
exemption from the requirement of a tolerance without any numerical 
limitation.

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), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). 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 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 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: September 4, 2020.
Edward Messina,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended 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.  180.1379 to subpart D to read as follows:


Sec.  180.1379  Pseudomonas fluorescens strain ACK55; exemption from 
the requirement of a tolerance.

    Residues of Pseudomonas fluorescens strain ACK55 are exempt from 
the requirement of a tolerance in or on all food commodities when used 
in accordance with label directions and good agricultural practices.

[FR Doc. 2020-20622 Filed 9-25-20; 8:45 am]
BILLING CODE 6560-50-P


