Document ID: EPA-HQ-OPP-2017-0526-0009
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: Purpureocillium lilacinum strain 251
Posted Date: 2019-12-20T05:00Z

[Federal Register Volume 84, Number 245 (Friday, December 20, 2019)]
[Rules and Regulations]
[Pages 70021-70023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27378]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0526; FRL-10002-01]

Purpureocillium lilacinum Strain 251; Amendment to the 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 tolerance exemption for 
residues of Paecilomyces lilacinus strain 251 in or on all food 
commodities due to a scientific reclassification of the substance as 
Purpureocillium lilacinum. Bayer CropScience LP submitted a petition to 
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting 
this amendment. This regulation eliminates the need to establish a 
maximum permissible level for residues of Purpureocillium lilacinum 
strain 251 under FFDCA.

DATES: This regulation is effective December 20, 2019. Objections and 
requests for hearings must be received on or before February 18, 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-2017-0526, is available at http://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 is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, 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 
http://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-2017-0526 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 
February 18, 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-2017-0526, by one of 
the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of December 15, 2017 (82 FR 59604) (FRL-
9970-50), 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 
petition (PP 7F8547) by Bayer CropScience, LP, 2 TW Alexander Drive, 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
180.1257 be amended by changing the name of the microbial from 
Paecilomyces lilacinus strain 251 to Purpureocillium lilacinum strain 
251. That document referenced a summary of the petition prepared by the 
petitioner Bayer CropScience LP, which is available in the docket via 
http://www.regulations.gov. Although comments submitted to the docket 
for this notice of filing, none were relevant to this tolerance 
rulemaking.

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 for 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

[[Page 70022]]

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.''
    The species lilacinus, formerly considered within the genus 
Paecilomyces, has been moved to the genus Purpureocillium and renamed 
lilacinum. The new taxonomy is presented in a 2011 scientific paper 
discussed and referenced in EPA's supporting document mentioned later 
in this paragraph. The strain-specific features and properties, 
including toxicological aspects of Paecilomyces lilacinus strain 251, 
have not changed due to the name change. Therefore, the risk 
assessments and tolerance exemption rationale for Paecilomyces 
lilacinus strain 251 apply to the new taxonomic classification, 
Purpureocillium lilacinum strain 251.
    EPA evaluated the available toxicity and exposure data on 
Purpureocillium lilacinum strain 251 and considered its 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 that data can be found 
within the document entitled ``Federal Food, Drug, and Cosmetic Act 
(FFDCA) Safety Determination for Purpureocillium lilacinum strain 
251.'' 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 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 
Purpureocillium lilacinum strain 251. Therefore, the existing tolerance 
exemption for Paecilomyces lilacinus strain 251 is amended by updating 
the name of the exempt substance from Paecilomyces lilacinus strain 251 
to Purpureocillium lilacinum strain 251.

B. Analytical Enforcement Methodology

    An analytical method is not required for Purpureocillium lilacinum 
strain 251 because EPA is amending 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 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: November 20, 2019.
Robert McNally,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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.  180.1257 to read as follows:

Sec.  180.1257  Purpureocillium lilacinum strain 251; exemption from 
the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues

[[Page 70023]]

of Purpureocillium lilacinum strain 251 in or on all food commodities 
when applied/used in accordance with label directions and good 
agricultural practices.

[FR Doc. 2019-27378 Filed 12-19-19; 8:45 am]
BILLING CODE 6560-50-P