[Federal Register Volume 84, Number 117 (Tuesday, June 18, 2019)]
[Rules and Regulations]
[Pages 28235-28237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12748]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0560; FRL-9994-90]


Bacillus amyloliquefaciens subspecies plantarum strain FZB42; 
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 Bacillus amyloliquefaciens subspecies 
plantarum strain FZB42 in or on all food commodities when used in 
accordance with label directions and good agricultural practices. 
Andermatt Biocontrol AG (c/o SciReg, Inc.) 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 permissible level for 
residues of Bacillus amyloliquefaciens subspecies plantarum strain 
FZB42 in or on all food commodities under FFDCA.

DATES: This regulation is effective June 18, 2019. Objections and 
requests for hearings must be received on or before August 19, 2019 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-2014-0560, 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 Printing 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-2014-0560 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 
August 19, 2019. 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

[[Page 28236]]

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-2014-
0560, 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 May 18, 2018 (83 FR 23247) (FRL-9976-
87), 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 petition (PP 
7F8620) by Andermatt Biocontrol AG, Stahlermatten 6, CH-6146 
Grossdietwil, Switzerland (c/o SciReg, Inc., 12733 Director's Loop, 
Woodbridge, VA 22192). The petition requested that 40 CFR part 180 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of the fungicide Bacillus amyloliquefaciens 
subspecies plantarum strain FZB42 in or on all food commodities. That 
Notice referenced a summary of the petition prepared by the petitioner 
Andermatt Biocontrol AG and available in the docket via http://www.regulations.gov. Comments were received on the notice of filing. 
EPA's response to these comments is discussed 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 toxicity and exposure data on Bacillus 
amyloliquefaciens subspecies plantarum strain FZB42 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 ``Federal Food, Drug, 
and Cosmetic Act (FFDCA) Safety Determination for Bacillus 
amyloliquefaciens subspecies plantarum strain FZB42'' (Safety 
Determination). This document, as well as other relevant information, 
is available in the docket for this action as described under 
ADDRESSES.
    The available data demonstrated that, with regard to humans, 
Bacillus amyloliquefaciens subspecies plantarum strain FZB42 is not 
toxic, pathogenic, or infective via any route of exposure. Although 
there may be some exposure to residues when Bacillus amyloliquefaciens 
subspecies plantarum strain FZB42 is used on food commodities in 
accordance with label directions and good agricultural practices, 
dietary exposure to such residues presents no concern for adverse 
effects. EPA also determined that a Food Quality Protection Act (FQPA) 
safety factor was not necessary as part of the qualitative assessment 
conducted for Bacillus amyloliquefaciens subspecies plantarum strain 
FZB42. These findings are discussed in more detail in the Safety 
Determination.
    Based upon its evaluation in the Safety Determination, 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 Bacillus amyloliquefaciens subspecies plantarum 
strain FZB42. Therefore, an exemption from the requirement of a 
tolerance is established for residues of Bacillus amyloliquefaciens 
subspecies plantarum strain FZB42 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.

C. Response to Comments

    Three comments were received in response to the notice of filing. 
EPA reviewed the comments and determined that they are irrelevant to 
the tolerance exemption in this action.

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

[[Page 28237]]

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 10, 2019.
Richard Keigwin,
Director, 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. Add Sec.  180.1367 to subpart D to read as follows:


Sec.  180.1367  Bacillus amyloliquefaciens subspecies plantarum strain 
FZB42; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Bacillus amyloliquefaciens subspecies plantarum strain 
FZB42 in or on all food commodities when used in accordance with label 
directions and good agricultural practices.

[FR Doc. 2019-12748 Filed 6-17-19; 8:45 am]
BILLING CODE 6560-50-P


