Document ID: EPA-HQ-OPP-2019-0097-0003
Agency: epa
Document Type: Rule
Title: Tolerance Exemption: Bacillus thuringiensis Cry14Ab-1 Protein in Soybean
Posted Date: 2020-06-08T04:00Z

[Federal Register Volume 85, Number 110 (Monday, June 8, 2020)]
[Rules and Regulations]
[Pages 34646-34648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11676]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2019-0097; FRL-10008-72]

Bacillus thuringiensis Cry14Ab-1 Protein in Soybean; 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 the Bacillus thuringiensis Cry14Ab-1 
protein (hereafter referred to as Cry14Ab-1) in or on soybean when used 
as a Plant-Incorporated Protectant (PIP). BASF Corporation 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 Cry14Ab-1.

DATES: This regulation is effective June 8, 2020. Objections and 
requests for hearings must be received on or before August 7, 2020, 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-2019-0097, 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 Publishing 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-2019-0097 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 7, 2020. 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-2019-0097, 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,

[[Page 34647]]

along with more information about dockets generally, is available at 
http://www.epa.gov/dockets.

II. Background

    In the Federal Register of June 28, 2019 (84 FR 30976) (FRL-9995-
27), 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 8F8722) by BASF Corporation, 26 Davis Drive, Research 
Triangle Park, NC 27709. The petition requested that 40 CFR part 174 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of the plant-incorporated protectant Cry14Ab-1 
protein in soybean. That document referenced a summary of the petition 
prepared by the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    A temporary exemption from the requirement of a tolerance (40 CFR 
174.538) was previously granted (82 FR 57137) for Cry14Ab-1 protein in 
soybean as part of an Experimental Use Permit (EPA Registration Number 
264-EUP-151). This temporary exemption expired on April 1, 2020.

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 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 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 Cry14Ab-1 
and considered their validity, completeness, and reliability, as well 
as the relationship of this information to human risk. A summary 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 Cry14Ab-1 Protein'' 
(Safety Determination). This document, as well as other relevant 
information, is available in the docket for this action EPA-HQ-OPP-
2019-0097.
    The available data demonstrated that, with regard to humans, 
Cry14Ab-1 is not toxic or allergenic via any route of exposure. 
Although there may be some exposure to residues when Cry14Ab-1 is used 
in soybeans as a plant-incorporated protectant, exposure to such 
residues presents no concern for adverse effects. Non-dietary exposure 
via inhalation is not likely since Cry14Ab-1 is contained within plant 
cells, which essentially eliminates this exposure route or reduces it 
to negligible levels. Non-dietary exposure via the skin is somewhat 
more likely via contact with soybean products which might have been 
processed in a way that disrupts cellular structure. However, there are 
no risks associated with this exposure route to the Cry14Ab-1 protein 
itself, because it would be present in the plant at low levels, and is 
not toxic or allergenic. EPA also determined that a Food Quality 
Protection Act (FQPA) safety factor was not necessary as part of the 
qualitative assessment conducted for Cry14Ab-1, due to the low risk of 
this pesticide. 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 Cry14Ab-1. Therefore, an exemption from the 
requirement of a tolerance is established for residues of Cry14Ab-1 in 
or on soybeans when used in accordance with label directions and good 
agricultural practices. In addition, EPA is removing the temporary 
exemption for Cry14Ab-1 (40 CFR 174.538) that was established for an 
Experimental Use Permit (EPA Registration Number 264-EUP-151) as that 
exemption expired on April 1, 2020.

B. Analytical Enforcement Methodology

    EPA has determined that an analytical method is not required for 
enforcement purposes since the Agency is establishing an exemption from 
the requirement of a tolerance without any numerical limitation. 
Nonetheless, an Enzyme-Linked Immunosorbent Assay (ELISA) that detects 
Cry14Ab-1 protein in soybean seed was submitted by the petitioner as an 
analytical method. The analytical method is available as a test kit 
(EnviroLogix QualiPlateTM Cry14Ab ELISA kit number AP 052). 
An independent laboratory validation of the analytical method showed 
that the test kit was accurate for the detection of Cry14Ab-1 protein 
in grain composites containing Cry14Ab-1 soybean grain at 1 in 200 and 
1 in 800 levels. Therefore, the limit of detection for Cry14Ab-1 
protein in ground soybean grain was confirmed as one Cry14Ab-1 soybean 
seed in 800 total seeds.

IV. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of 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 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

[[Page 34648]]

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 174

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

    Dated: May 14, 2020.
Richard Keigwin,
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.

Sec.  174.538  [Removed]

0
2. Remove Sec.  174.538.

0
3. Add Sec.  174.540 to subpart W to read as follows:

Sec.  174.540  Bacillus thuringiensis Cry14Ab-1 protein; exemption from 
the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry14Ab-1 protein in or on 
soybean food and feed commodities are exempt from the requirement of a 
tolerance when used as a plant-incorporated protectant in soybean.

[FR Doc. 2020-11676 Filed 6-5-20; 8:45 am]
 BILLING CODE 6560-50-P