Document ID: EPA-HQ-OPP-2011-0012-0003
Agency: epa
Document Type: Rule
Title: Tolerance Requirements; Exemptions: Heat-killed Burkholderia spp. Strain A396 Cells and Spent Fermentation Media
Posted Date: 2014-03-21T04:00Z

[Federal Register Volume 79, Number 55 (Friday, March 21, 2014)]
[Rules and Regulations]
[Pages 15702-15704]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06228]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0012; FRL-9907-41]

Heat-killed Burkholderia spp. Strain A396 Cells and Spent 
Fermentation Media; 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 heat-killed Burkholderia spp. strain 
A396 cells and spent fermentation media in or on all food commodities 
when applied as a biological insecticide to agricultural crops and used 
in accordance with label directions and good agricultural practices. 
Marrone Bio Innovations, 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 heat-killed Burkholderia spp. strain A396 cells and spent 
fermentation media under FFDCA.

DATES: This regulation is effective March 21, 2014. Objections and 
requests for hearings must be received on or before May 20, 2014, 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-2011-0012, is available at http://www.regulations.gov or at the Office of Pesticide Programs

[[Page 15703]]

Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency 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: Michael Glikes, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 305-6231; email 
address: glikes.michael@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-2011-0012 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 May 20, 2014. 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-2011-0012, 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 February 25, 2011 (76 FR 10587) (FRL-
8863-4), 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 0F7778) by Marrone Bio Innovations, Inc. 2121 Second 
Street, Suite B-107, Davis, CA 95618. The petition requested that 40 
CFR part 180 be amended by establishing an exemption from the 
requirement of a tolerance for residues of Burkholderia spp. strain 
A396. Subsequently, the applicant modified its manufacturing process 
and changed the active ingredient from a live microbe to one that is 
inactivated by applying high temperatures during the production of the 
manufacturing product. Hence, the active ingredient in the end-use 
product applied to crops is ``heat-killed.'' The notice referenced a 
summary of the petition prepared by the petitioner, Marrone Bio 
Innovations 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 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 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, 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 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 heat-
killed Burkholderia spp. strain A396 cells and spent fermentation media 
and considered its validity, completeness, and reliability, as well as 
the relationship of this information to human risk. Based upon that 
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 heat-killed 
Burkholderia spp. strain A396 cells and spent fermentation media. 
Therefore, an exemption from the requirement of a tolerance is 
established for residues of heat-killed Burkholderia spp. strain A396 
cells and spent fermentation media 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 EPA

[[Page 15704]]

relied and its risk assessment based on that data can be found within 
the February 28, 2014 document entitled ``Federal Food, Drug, and 
Cosmetic Act (FFDCA) Considerations for Heat-killed Burkholderia spp. 
strain A396 cells and spent fermentation media.'' This document, as 
well as other relevant information, is available in the docket 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 aforementioned February 28, 2014 
document, and because EPA is establishing an exemption from the 
requirement of a tolerance without any numerical limitation.

C. International Residue Limits

    In making its tolerance decisions, 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, 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. EPA may establish a tolerance that is 
different from a Codex MRL; however, FFDCA section 408(b)(4) requires 
that EPA explain the reasons for departing from the Codex level.
    The Codex has not established a MRL for heat-killed Burkholderia 
spp. strain A396 cells and spent fermentation media.

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 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, 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 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 EPA 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.), 
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: February 28, 2014.
Steve 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.  180.1325 to subpart D to read as follows:

Sec.  180.1325  Heat-killed Burkholderia spp. strain A396 cells and 
spent fermentation media exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of heat-killed Burkholderia spp. strain A396 cells and spent 
fermentation media in or on all food commodities when applied as a 
biological insecticide to agricultural crops and used in accordance 
with label directions and good agricultural practices.

[FR Doc. 2014-06228 Filed 3-20-14; 8:45 am]
BILLING CODE 6560-50-P