Document ID: EPA-HQ-OPP-2018-0403-0006
Agency: epa
Document Type: Rule
Title: Tolerance Exemption: Bacillus Thuringiensis Cry1Ab/Cry2Aj Protein and G10-evo Enolpyruvylshikimate-3-Phosphate Synthase (G10evo-EPSPS) Protein
Posted Date: 2021-01-15T05:00Z

[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Rules and Regulations]
[Pages 3827-3830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28122]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2018-0403; FRL-10015-98]

Bacillus Thuringiensis Cry1Ab/Cry2Aj Protein and G10-evo 
Enolpyruvylshikimate-3-Phosphate Synthase (G10evo-EPSPS) Protein; 
Exemptions From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of the insecticide Bacillus thuringiensis 
Cry1Ab/Cry2Aj protein in or on the food and feed commodities of corn; 
corn, field; corn, sweet; and corn, pop, and for residues of the inert 
ingredient G10-evo Enolpyruvylshikimate-3-phosphate synthase (G10evo-
EPSPS) protein in or on the food and feed commodities of all crops when 
used in a plant-incorporated protectant. Hangzhou Ruifeng Biosciences 
Co., Ltd. submitted a petition to EPA under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), requesting exemptions from the requirement of a 
tolerance for these pesticide chemical residues. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of Bacillus thuringiensis Cry1Ab/Cry2Aj and G10evo-EPSPS 
proteins.

DATES: This regulation is effective January 15, 2021. Objections and 
requests for hearings must be received on or before March 16, 2021, 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-2018-0403, 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: Charles Smith, 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).

[[Page 3828]]

     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-2018-0403 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 
March 16, 2021. 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-2018-0403, 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.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of December 21, 2018 (83 FR 65660) (FRL-
9985-67) and March 18, 2019 (84 FR 9735) (FRL-9989-90), EPA issued 
documents pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), 
announcing the filing of pesticide tolerance petitions (PP 8E8669 and 
IN-11257) by Hangzhou Ruifeng Biosciences Co., Ltd., 1500 Wenyi Rd., 
Building 1, Room 103, Hangzhou, China (c/o GA Bannon Consulting LLC, 13 
Blue Flag Court, Dardenne Prairie, MO 63368). Petition 8E8669 requested 
that 40 CFR part 180 be amended by establishing an exemption from the 
requirement of a tolerance for residues of Bacillus thuringiensis 
fusion protein Cry1Ab/Cry2Aj in or on the food and feed commodities of 
corn, field; corn, sweet; and corn, pop when used as a plant-
incorporated protectant in corn; Petition IN-11257 requested that 40 
CFR part 180 be amended by establishing an exemption from the 
requirement of a tolerance for residues of Deinococcus radiodurans 5-
enolpyruvylshikimate-3-phosphate synthase (EPSPS) protein in or on all 
food commodities when used as an inert ingredient in a plant-
incorporated protectant. The documents referenced a summary of each 
petition prepared by the petitioner Hangzhou Ruifeng Biosciences Co., 
Ltd., which are available in the docket, http://www.regulations.gov. 
One comment was received on the notice of filing that published on 
December 21, 2018. EPA's response to this comment is discussed in Unit 
VII.B of the document titled ``Federal Food, Drug, and Cosmetic Act 
(FFDCA) Safety Determination for Cry1Ab/Cry2Aj and G10evo-EPSPS 
Proteins'' available in the docket.

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.''
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
these actions and considered their validity, completeness and 
reliability, and the relationship of this information to human risk. 
EPA has also considered available information concerning the 
variability of the sensitivities of major identifiable subgroups of 
consumers, including infants and children. A summary of the data upon 
which EPA relied and its risk assessment based on those data can be 
found within the document entitled ``Final Human Health Risk Assessment 
and Review of Product Characterization of the Insecticidal Plant-
Incorporated Protectant Bacillus thuringiensis Cry1Ab/Cry2Aj, a G10evo-
EPSPS Herbicide Tolerance Protein, and the Genetic Material Necessary 
for their Production in ShuangKang 12-5 Maize and Establishment of a 
Permanent Tolerance Exemption.'' This document, as well as other 
relevant information, is available in the docket for this action EPA-
HQ-OPP-2018-0403.
    The Bacillus thuringiensis Cry1Ab/Cry2Aj fusion protein is an 
active ingredient produced within the plant to confer protection 
against lepidopteran pests. The Deinococcus radiodurans 5-
enolpyruvylshikimate-3-phosphate synthase (EPSPS) protein (hereafter 
referred to by its common name ``G10evo-EPSPS'') protein is an inert 
ingredient used as a selectable marker that is produced in the plant 
and confers tolerance to the herbicide glyphosate. The available data 
demonstrated that, with regard to humans, the Cry1Ab/Cry2Aj fusion 
protein and G10evo-EPSPS are not toxic or allergenic via any 
anticipated route of

[[Page 3829]]

exposure. Dietary exposure is the most relevant route of exposure, and 
the Agency concludes that dietary exposure would present no harm 
because of the lack of toxicity or allergenicity of either protein. In 
addition, both proteins are contained within plant cells, which 
essentially eliminates the dermal and inhalation exposure routes or 
reduces them to negligible levels. EPA also determined that a Food 
Quality Protection Act (FQPA) safety factor was not necessary as part 
of the qualitative assessment conducted for Cry1Ab/Cry2Aj and G10evo-
EPSPS, due to the low risk of these ingredients. These findings are 
discussed in more detail in the document titled ``Federal Food, Drug, 
and Cosmetic Act (FFDCA) Safety Determination for Cry1Ab/Cry2Aj and 
G10evo-EPSPS Proteins.'' Based upon its evaluation in the Federal Food, 
Drug, and Cosmetic Act (FFDCA) Safety Determination for Cry1Ab/Cry2Aj 
and G10evo-EPSPS Proteins, 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 Cry1Ab/
Cry2Aj and G10evo-EPSPS. Therefore, exemptions from the requirement of 
a tolerance are established for residues of the Bacillus thuringiensis 
Cry1Ab/Cry2Aj fusion protein in or on the food and feed commodities of 
corn, field; corn, sweet; and corn, pop when used as a plant-
incorporated protectant in corn, and for residues of G10-evo EPSPS 
protein in or on the food and feed commodities of all crops when used 
as an inert ingredient in a plant-incorporated protectant.

B. Analytical Enforcement Methodology

    The petitioner submitted Enzyme-Linked Immunosorbent Assays 
(ELISAs) that detect the G10evo-EPSPS protein and the Cry1Ab/Cry2Aj 
protein in corn seed, along with a PCR method for use as a Cry1Ab/
Cry2Aj screening and confirmation tool. G10evo-EPSPS protein is 
detectable via a quantitative, ``sandwich'' ELISA assay using a 
commercially available kit (YouLong, Catalog # AA1141). Cry1Ab/Cry2Aj 
protein is detectable by combining a PCR screening method targeting the 
junction sequence of the cry1Ab/cry2Aj fusion gene followed by an ELISA 
assay to detect the Cry1Ab protein. The ELISA assay provided is the 
commercially available QualiPlate Kit for Cry1Ab/Cry1Ac (Envirologix, 
Catalog # AP-003-CRBS), which is designed to detect the Cry1Ab protein 
in corn leaf and seed samples.

C. Revisions to the Requested Tolerance Exemption

    The following modifications were made to the original requests for 
an exemption from a tolerance:
    1. EPA replaced ``40 CFR part 180'' with ``40 CFR part 174'' 
because PIP tolerance exemptions are published in part 174.
    2. Changed the name from ``Bacillus thuringiensis fusion protein 
Cry1Ab/Cry2Aj'' to ``Bacillus thuringiensis Cry1Ab/Cry2Aj protein,'' to 
align with nomenclature for other exemptions published in 40 CFR part 
174.
    3. Changed the name from ``Deinococcus radiodurans 5-
enolpyruvylshikimate-3-phosphate synthase (EPSPS) protein'' to ``G10evo 
Enolpyruvylshikimate-3-phosphate synthase (G10evo-EPSPS) protein,'' to 
align with nomenclature for other exemptions published in 40 CFR part 
174.

IV. Statutory and Executive Order Reviews

    This action establishes exemptions from the requirement of a 
tolerance 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 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 (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 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 action 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 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 Agency 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 5, 2020.
Edward Messina,
Acting Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

[[Page 3830]]

PART 174--PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED 
PROTECTANTS

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.  174.542 to read as follows:

Sec.  174.542   Bacillus thuringiensis Cry1Ab/Cry2Aj protein in corn; 
exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry1Ab/Cry2Aj protein in or on 
the food or feed commodities of corn, field; corn, sweet; and corn, 
pop, are exempt from the requirement of a tolerance when used as a 
plant-incorporated protectant in corn.

0
3. Add Sec.  174.543 to read as follows:

Sec.  174.543   G10evo-EPSPS protein in all plants; exemption from the 
requirement of a tolerance.

    Residues of G10evo-Enolpyruvylshikimate-3-phosphate synthase 
(G10evo-EPSPS) protein in or on all food or feed commodities, are 
exempt from the requirement of a tolerance when used as an inert 
ingredient in a plant-incorporated protectant.

[FR Doc. 2020-28122 Filed 1-14-21; 8:45 am]
BILLING CODE 6560-50-P