Document ID: EPA-HQ-OPP-2013-0704-0004
Agency: epa
Document Type: Rule
Title: Exemptions from Requirement of a Tolerance: Bacillus thuringiensis Cry1F Protein in Soybean
Posted Date: 2014-02-12T05:00Z

[Federal Register Volume 79, Number 29 (Wednesday, February 12, 2014)]
[Rules and Regulations]
[Pages 8293-8295]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02932]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2013-0704; FRL-9905-59]

Bacillus thuringiensis Cry1F Protein in Soybean; 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 the plant-incorporated protectant (PIP), 
Bacillus thuringiensis Cry1F protein, in or on the food commodity 
soybean. Dow AgroSciences LLC 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 
thuringiensis Cry1F protein in soybean under the FFDCA.

DATES: This regulation is effective February 12, 2014. Objections and 
requests for hearings must be received on or before April 14, 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-2013-0704, 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), 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

[[Page 8294]]

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: Denise Greenway, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8263; email 
address: greenway.denise@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 174 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, 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-2013-0704 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 
April 14, 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-2013-0704, 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 and Statutory Findings

    In the Federal Register of November 22, 2013 (78 FR 70007) (FRL-
9902-96), 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 2F8066) by Dow AgroSciences LLC, 9330 Zionsville Road, 
Indianapolis, IN 46268. The petition requested that 40 CFR part 174 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of Bacillus thuringiensis Cry1F protein in or on 
the food commodity soybean. That document referenced a summary of the 
petition prepared by the petitioner, Dow AgroSciences LLC, which is 
available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    Exemptions from the requirement of a tolerance currently exist for 
residues of Bacillus thuringiensis Cry1F protein in cotton (40 CFR 
174.504) and corn (40 CFR 174.520). EPA is establishing an exemption 
for residues of Bacillus thuringiensis Cry1F protein in soybean by 
amending the existing exemption in Sec.  174.504 to add soybean 
commodities. In addition, as a housekeeping measure, EPA is 
consolidating the existing exemptions for Bacillus thuringiensis Cry1F 
protein into one regulatory provision without making any substantive 
alterations in the existing exemptions.

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.'' 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 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 Agency 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 
thuringiensis Cry1F protein 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 
Bacillus thuringiensis Cry1F protein. Therefore, an exemption from the 
requirement of a tolerance is established for residues of Bacillus 
thuringiensis Cry1F protein in or on the food commodity soybean, when 
used as a PIP in soybean and in accordance with label directions and 
good agricultural practices. A full explanation of the data upon which 
EPA relied and its risk assessment based on those data can be found in 
a January 13, 2014 document entitled, ``Federal Food, Drug, and

[[Page 8295]]

Cosmetic Act (FFDCA) Considerations for Bacillus thuringiensis Cry1F 
Protein.'' This document, as well as other relevant information, is 
available in the docket for this action as described under ADDRESSES.

B. Analytical Enforcement Methodology

    EPA is establishing an exemption from the requirement of a 
tolerance without any numerical limitation. An analytical method for 
enforcement purposes was, however, submitted by Dow AgroSciences LLC 
and determined by the Agency to be suitable for quantitative 
measurements of the Cry1F protein in soybean tissue. The Dow 
AgroSciences LLC Cry1F Enzyme-Linked Immunosorbent Assay (ELISA) method 
is fully discussed in the January 13, 2014 document entitled, ``Federal 
Food, Drug and Cosmetic Act (FFDCA) Considerations for Bacillus 
thuringiensis Cry1F Protein.''

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 Agency. 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, nor does this 
action 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 Agency 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, the Agency 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 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 Agency 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 174

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: January 30, 2014.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 174--[AMENDED]

0
1. The authority citation for part 174 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Revise Sec.  174.504 to read as follows:

Sec.  174.504  Bacillus thuringiensis Cry1F protein; exemption from the 
requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry1F protein in the food and 
feed commodities of corn, field; corn, sweet; corn, pop; cotton; and 
soybean are exempt from the requirement of a tolerance when used as a 
plant-incorporated protectant in corn, field; corn, sweet; corn, pop; 
cotton, and soybean.

Sec.  174.520  [Removed]

0
3. Remove Sec.  174.520.
[FR Doc. 2014-02932 Filed 2-11-14; 8:45 am]
BILLING CODE 6560-50-P