Bacillus thuringiensis Cry14Ab-1 Protein in Soybean; Exemption From the Requirement of a Tolerance, 34646-34648 [2020-11676]
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Federal Register / Vol. 85, No. 110 / Monday, June 8, 2020 / Rules and Regulations
Section 309(g)(2)(A) of the Clean Water
Act, Class I civil penalties may not
exceed $22,321 per violation, except
that the maximum amount of any Class
I civil penalty shall not exceed $55,801.
Under Section 404(s)(4) of the Clean
Water Act, judicially-imposed civil
penalties may not exceed $55,801 per
day for each violation. Under Section
205(e) of the National Fishing
Enhancement Act, penalties for
violations of permits issued in
accordance with that Act shall not
exceed $24,441 for each violation.
TABLE 1 TO PARAGRAPH (a)(1)
Statutory civil monetary penalty amount for violations that occurred
after November 2, 2015, and are assessed on or after June 8, 2020
Environmental statute and U.S. code citation
Clean Water Act (CWA), Section 309(g)(2)(A), 33 U.S.C. 1319(g)(2)(A)
CWA, Section 404(s)(4), 33 U.S.C. 1344(s)(4) ........................................
National Fishing Enhancement Act, Section 205(e), 33 U.S.C. 2104(e)
40 CFR Part 174
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 https://www.epa.gov/dockets.
[EPA–HQ–OPP–2019–0097; FRL–10008–72]
FOR FURTHER INFORMATION CONTACT:
*
*
*
*
*
[FR Doc. 2020–11114 Filed 6–5–20; 8:45 am]
BILLING CODE 3720–58–P
ENVIRONMENTAL PROTECTION
AGENCY
Bacillus thuringiensis Cry14Ab-1
Protein in Soybean; Exemption From
the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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 PlantIncorporated 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 https://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
SUMMARY:
khammond on DSKJM1Z7X2PROD with RULES
$22,321 per violation, with a maximum of $55,801.
Maximum of $55,801 per day for each violation.
Maximum of $24,441 per violation.
VerDate Sep<11>2014
18:41 Jun 05, 2020
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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 https://
www.ecfr.gov/cgi-bin/text-idx?&
c=ecfr&tpl=/ecfrbrowse/Title40/40tab_
02.tpl.
PO 00000
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Fmt 4700
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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: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
E:\FR\FM\08JNR1.SGM
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Federal Register / Vol. 85, No. 110 / Monday, June 8, 2020 / Rules and Regulations
along with more information about
dockets generally, is available at https://
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 plantincorporated protectant Cry14Ab-1
protein in soybean. That document
referenced a summary of the petition
prepared by the petitioner, which is
available in the docket, https://
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
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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
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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 plantincorporated 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
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34647
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
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Federal Register / Vol. 85, No. 110 / Monday, June 8, 2020 / Rules and Regulations
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).
khammond on DSKJM1Z7X2PROD with RULES
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:
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18:41 Jun 05, 2020
Jkt 250001
Mitigation Administration, FEMA, 400
C Street SW, Washington, DC 20472,
■ 1. The authority citation for part 174
(202) 646–7659, or (email)
continues to read as follows:
patrick.sacbibit@fema.dhs.gov; or visit
the FEMA Mapping and Insurance
Authority: 7 U.S.C. 136–136y; 21 U.S.C.
eXchange (FMIX) online at
321(q), 346a and 371.
www.floodmaps.fema.gov/fhm/fmx_
§ 174.538 [Removed]
main.html.
■ 2. Remove § 174.538.
SUPPLEMENTARY INFORMATION: The
■ 3. Add § 174.540 to subpart W to read
Federal Emergency Management Agency
as follows:
(FEMA) makes the final determinations
listed below for the modified BFEs for
§ 174.540 Bacillus thuringiensis Cry14Ab-1
each community listed. These modified
protein; exemption from the requirement of
elevations have been published in
a tolerance.
newspapers of local circulation and
Residues of Bacillus thuringiensis
ninety (90) days have elapsed since that
Cry14Ab-1 protein in or on soybean
publication. The Deputy Associate
food and feed commodities are exempt
Administrator for Insurance and
from the requirement of a tolerance
Mitigation has resolved any appeals
when used as a plant-incorporated
resulting from this notification.
protectant in soybean.
This final rule is issued in accordance
[FR Doc. 2020–11676 Filed 6–5–20; 8:45 am]
with section 110 of the Flood Disaster
BILLING CODE 6560–50–P
Protection Act of 1973, 42 U.S.C. 4104,
and 44 CFR part 67. FEMA has
developed criteria for floodplain
management in floodprone areas in
DEPARTMENT OF HOMELAND
accordance with 44 CFR part 60.
SECURITY
Interested lessees and owners of real
Federal Emergency Management
property are encouraged to review the
Agency
proof Flood Insurance Study and FIRM
available at the address cited below for
each community. The BFEs and
44 CFR Part 67
modified BFEs are made final in the
[Docket ID FEMA–2020–0002]
communities listed below. Elevations at
selected locations in each community
Final Flood Elevation Determinations
are shown.
AGENCY: Federal Emergency
National Environmental Policy Act.
Management Agency, DHS.
FEMA included flood hazard mapping
data dissemination determinations as
ACTION: Final rule.
part of the NFIP Nationwide
SUMMARY: Base (1% annual-chance)
Programmatic Environmental Impact
Flood Elevations (BFEs) and modified
Statement, published on November 3,
BFEs are made final for the
2017, and completed in accordance with
communities listed below. The BFEs
the Council on Environmental Quality’s
and modified BFEs are the basis for the
National Environmental Policy Act
floodplain management measures that
implementing regulations in 40 CFR
each community is required either to
1500 through 1508 and therefore has
adopt or to show evidence of being
determined that this action will not
already in effect in order to qualify or
have a significant effect on the human
remain qualified for participation in the environment.
National Flood Insurance Program
Regulatory Flexibility Act. As flood
(NFIP).
elevation determinations are not within
DATES: The date of issuance of the Flood the scope of the Regulatory Flexibility
Act, 5 U.S.C. 601–612, a regulatory
Insurance Rate Map (FIRM) showing
flexibility analysis is not required.
BFEs and modified BFEs for each
Regulatory Classification. This final
community. This date may be obtained
rule is not a significant regulatory action
by contacting the office where the maps
under the criteria of section 3(f) of
are available for inspection as indicated
Executive Order 12866 of September 30,
in the table below.
1993, Regulatory Planning and Review,
ADDRESSES: The final BFEs for each
58 FR 51735.
community are available for inspection
Executive Order 13132, Federalism.
at the office of the Chief Executive
This final rule involves no policies that
Officer of each community. The
have federalism implications under
respective addresses are listed in the
Executive Order 13132.
table below.
Executive Order 12988, Civil Justice
FOR FURTHER INFORMATION CONTACT: Rick Reform. This final rule meets the
applicable standards of Executive Order
Sacbibit, Chief, Engineering Services
12988.
Branch, Federal Insurance and
PART 174—[AMENDED]
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]]>Agencies
[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.
-----------------------------------------------------------------------
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 https://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 https://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:
[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 180 through the Government Publishing Office's e-CFR site at
https://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: https://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 https://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
https://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, https://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
