Document ID: EPA-HQ-OPP-2012-0264-0005
Agency: epa
Document Type: Rule
Title: Exemptions from Requirement of a Tolerance: Bacillus pumilus strain BU F-33
Posted Date: 2013-06-12T04:00Z

[Federal Register Volume 78, Number 113 (Wednesday, June 12, 2013)]
[Rules and Regulations]
[Pages 35147-35149]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13821]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0264; FRL-9389-2]

Bacillus pumilus Strain BU F-33; Exemption From the Requirement 
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of Bacillus pumilus strain BU F-33 in or on 
all food commodities when applied to elicit induced systemic resistance 
in plants and used in accordance with label directions and good 
agricultural practices. Becker Underwood, Inc., submitted a petition to 
the 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 pumilus strain BU F-33 under the FFDCA.

DATES: This regulation is effective June 12, 2013. Objections and 
requests for hearings must be received on or before August 12, 2013, 
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-2012-0264, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency

[[Page 35148]]

Docket Center (EPA/DC), EPA West 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: Jeannine Kausch, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 347-8920; email 
address: kausch.jeannine@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 the EPA, you must 
identify docket ID number EPA-HQ-OPP-2012-0264 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 12, 2013. 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 the EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0264, 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.htm.
    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 September 28, 2012 (77 FR 59578) (FRL-
9364-6), the 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 2F7978) by Becker Underwood, Inc., 801 Dayton Ave., P.O. 
Box 667, Ames, IA 50010. The petition requested that 40 CFR part 180 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of Bacillus pumilus strain BU F-33. The notice 
referenced a summary of the petition prepared by the petitioner, Becker 
Underwood, Inc., which is available in the docket via http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

III. Final Rule

A. The EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows the 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 the 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.'' Pursuant to FFDCA 
section 408(c)(2)(B), in establishing or maintaining in effect an 
exemption from the requirement of a tolerance, the EPA must take into 
account the factors set forth in FFDCA section 408(b)(2)(C), which 
require the EPA to give special consideration to exposure of infants 
and children to the pesticide chemical residue in establishing a 
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 the 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 EPA evaluated the available toxicity and exposure data on 
Bacillus pumilus strain BU F-33 and considered its validity, 
completeness, and reliability, as well as the relationship of this 
information to human risk. Based upon that evaluation, the 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 pumilus strain BU F-33. Therefore, an 
exemption from the requirement of a tolerance is established for 
residues of Bacillus pumilus strain BU F-33 in or on all food 
commodities when applied to elicit induced systemic resistance in 
plants and used in accordance with label directions and good 
agricultural practices. A full explanation of the data upon which the 
EPA relied and its risk assessment based on that data can be found 
within the May 22, 2013 document entitled ``Federal Food, Drug, and 
Cosmetic Act (FFDCA) Considerations for Bacillus pumilus strain BU F-
33.'' This document, as well as other relevant information, is 
available in the docket

[[Page 35149]]

for this action as described under ADDRESSES.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes for 
the reasons stated above and in the document entitled ``Federal Food, 
Drug, and Cosmetic Act (FFDCA) Considerations for Bacillus pumilus 
strain BU F-33,'' and because the EPA is establishing an exemption from 
the requirement of a tolerance without any numerical limitation.

C. International Residue Limits

    In making its tolerance decisions, the EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. In this 
context, the EPA considers the international maximum residue limits 
(MRLs) established by the Codex Alimentarius Commission (Codex), as 
required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint 
United Nations Food and Agriculture Organization/World Health 
Organization food standards program, and it is recognized as an 
international food safety standards-setting organization in trade 
agreements to which the United States is a party. The EPA may establish 
a tolerance that is different from a Codex MRL; however, FFDCA section 
408(b)(4) requires that the EPA explain the reasons for departing from 
the Codex level.
    The Codex has not established a MRL for Bacillus pumilus strain BU 
F-33.

IV. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption under FFDCA 
section 408(d) in response to a petition submitted to the 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 
final rule has been exempted from review under Executive Order 12866, 
this final rule 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 final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA) (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 final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) do not apply.
    This final rule 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, the 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, the 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 final rule. In addition, this final rule 
does not impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require the EPA's consideration of voluntary consensus standards 
pursuant to section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the 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: May 31, 2013.
Steven Bradbury,
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.  180.1322 to subpart D to read as follows:

Sec.  180.1322  Bacillus pumilus strain BU F-33; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Bacillus pumilus strain BU F-33 in or on all food 
commodities when applied to elicit induced systemic resistance in 
plants and used in accordance with label directions and good 
agricultural practices.

[FR Doc. 2013-13821 Filed 6-11-13; 8:45 am]
BILLING CODE 6560-50-P