Document ID: EPA-HQ-OPP-2017-0113-0004
Agency: epa
Document Type: Rule
Title: Temporary Tolerance Exemptions: Bacillus thuringiensis Cry14Ab-1 Protein in or on Soybean
Posted Date: 2017-12-04T05:00Z

[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Rules and Regulations]
[Pages 57135-57137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26080]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2017-0113; FRL-9970-43]

Bacillus thuringiensis Cry14Ab-1 Protein in or on Soybean; 
Temporary Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a temporary exemption from the 
requirement of a tolerance for residues of the Bacillus thuringiensis 
Cry14Ab-1 protein in or on soybean, when used as a plant-incorporated 
protectant (PIP) in soybean plants, in accordance with the terms of 
Experimental Use Permit (EUP) No. 264-EUP-151. Bayer CropScience LP., 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting the temporary tolerance exemption. This 
regulation eliminates the need under FFDCA to establish a maximum 
permissible level for residues of Cry14Ab-1 protein. The temporary 
tolerance exemption expires on April 1, 2020.

DATES: This regulation is effective December 4, 2017. Objections and 
requests for hearings must be received on or before February 2, 2018, 
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-2017-0113, 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

[[Page 57136]]

number: (703) 305-7090; email address: [email protected].

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(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-2017-0113 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 2, 2018. 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-2017-0113, 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 June 8, 2017 (82 FR 26641) (FRL-9961-
14), 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 6F8541) by Bayer CropScience LP., 2 T.W. Alexander Dr., 
Research Triangle Park, NC 27709. The petitioner requested that 40 CFR 
part 180 be amended by establishing a temporary exemption from the 
requirement of a tolerance for residues of the plant-pesticide Bacillus 
thuringiensis Cry14Ab-1 in or on soybean. 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. 
There were no comments received in response to the Notice of Filing.
    EPA is establishing a temporary exemption that varies slightly from 
the request, as explained in Unit III.C.

III. Final Rule

A. EPA's Safety Determination

    Section 408(r) of FFDCA authorizes EPA to establish a temporary 
exemption from the requirement of a tolerance for residues covered by 
an experimental use permit issued under the Federal Insecticide, 
Fungicide, and Rodenticide Act. That section states that the provisions 
of section 408(c)(2) of FFDCA apply to exemptions issued under FFDCA 
section 408(r). 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 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 
thuringiensis Cry14Ab-1 and considered its validity, completeness, and 
reliability, as well as the relationship of this information to human 
risk. In summary, the available data does not indicate any adverse 
effects due to toxicity or allergenicity of the Cry14Ab-1 protein. A 
full explanation of the data upon which EPA relied and its risk 
assessments based on that data can be found within the document 
entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations 
for the Plant-Incorporated Protectant Pesticide Bacillus thuringiensis 
Cry14Ab-1.'' This document, as well as other relevant information, is 
available in the docket for this action as described under ADDRESSES.
    There is likely to be exposure to Cry14Ab-1 through consumption of 
soybean plants containing the pesticide, and there is potential for 
exposure in drinking water. There is unlikely to be residential or non-
occupational exposure due to incorporation within the plant and the 
lack of availability at this time of the plant for residential uses.
    Although FFDCA section 408(b)(2)(C) provides for an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects, EPA has determined that there are no such

[[Page 57137]]

effects due to the lack of toxicity and allergenicity for this PIP. As 
a result, an additional margin of safety for the protection of infants 
and children is unnecessary.
    Based upon its evaluation, EPA concludes that there is reasonable 
certainty that no harm will result to the U.S. population, including 
infants and children, from aggregate exposure to residues of the 
Cry14Ab-1 protein in or on soybean. This includes all anticipated 
dietary exposures and all other exposures for which there is reliable 
information. The Agency has arrived at this conclusion based on the 
lack of toxicity and allergenicity for the Bacillus thuringiensis 
Cry14Ab-1 protein. Therefore, a temporary exemption is established for 
residues of this plant-incorporated protectant Bacillus thuringiensis 
Cry14Ab-1 protein in or on soybean.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes 
because EPA is establishing a temporary exemption from the requirement 
of a tolerance without any numerical limitation for which enforcement 
is unnecessary.

C. Revisions to the Requested Tolerance Exemption

    EPA's final rule revises the request from ``plant-pesticide'' to 
``plant-incorporated protectant'' to align with the Agency's language 
published in 40 CFR 174.3; adds the term ``temporary'' to reflect that 
this exemption is linked to the pending experimental use permit action, 
and is published in part 174 rather than part 180, since PIP tolerance 
exemptions are published in part 174.

IV. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a 
tolerance 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); Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997); or 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 (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 action, 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 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 (UMRA) (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 (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: November 13, 2017.
Richard P. Keigwin, Jr.,
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: 7 U.S.C. 136-136y; 21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  174.538 to subpart W to read as follows:

Sec.  174.538  Bacillus thuringiensis Cry14Ab-1 protein in soybean; 
temporary exemption from the requirement of a tolerance.

    Residues of the protein Cry14Ab-1 in or on soybean are temporarily 
exempt from the requirement of a tolerance when used as a plant-
incorporated protectant in soybean plants in accordance with the terms 
of Experimental Use Permit No. 264-EUP-151. This temporary exemption 
from the requirement of a tolerance expires on April 1, 2020.

[FR Doc. 2017-26080 Filed 12-1-17; 8:45 am]
 BILLING CODE 6560-50-P