24-Epibrassinolide; Exemption From the Requirement of a Tolerance, 27966-27968 [2019-12743]
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27966
Federal Register / Vol. 84, No. 116 / Monday, June 17, 2019 / Rules and Regulations
G. Protest Activities
The Coast Guard respects the First
Amendment rights of protesters.
Protesters are asked to contact the
person listed in the FOR FURTHER
INFORMATION CONTACT section to
coordinate protest activities so that your
message can be received without
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[FR Doc. 2019–12763 Filed 6–14–19; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
Harbors, Marine safety, Navigation
(water), Reporting and recordkeeping
requirements, Security measures,
Waterways.
For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 165 as follows:
[EPA–HQ–OPP–2017–0487; FRL–9993–15]
PART 165—REGULATED NAVIGATION
AREAS AND LIMITED ACCESS AREAS
SUMMARY:
24-Epibrassinolide; Exemption From
the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
1. The authority citation for part 165
continues to read as follows:
Authority: 46 U.S.C. 70034, 70051; 33 CFR
1.05–1, 6.04–1, 6.04–6, and 160.5;
Department of Homeland Security Delegation
No. 0170.1.
2. Add § 165.T08–0309 to read as
follows:
■
§ 165.T08–0309 Safety Zone; Tennessee
River, Moors Resort and Marina Fireworks,
Gilbertsville, KY.
(a) Location. The safety zone will
cover all navigable waters of the
Tennessee River at mile marker 30.5
within a 600-foot radius from the
fireworks launch site on the entrance
jetty to Moors Resort and Marina in
Gilbertsville, KY.
(b) Enforcement period. The rule in
this section will be enforced from 8:45
p.m. until 9:45 p.m. on July 3, 2019.
(c) Regulations. (1) In accordance with
the general regulations in § 165.23,
entry into this zone is prohibited unless
authorized by the Captain of the Port
Sector Ohio Valley (COTP) or a
designated representative.
(2) Persons or vessels desiring to enter
into or pass through the zone must
request permission from the COTP or a
designated representative. They may be
contacted on VHF–FM Channel 16 or by
phone at 502–779–5400.
(3) If permission is granted, all
persons and vessels must transit at their
slowest safe speed and comply with all
lawful directions issued by the COTP or
a designated representative.
(d) Informational broadcasts. The
COTP or a designated representative
will inform the public through
broadcast notices to mariners of any
changes in the planned schedule.
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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
List of Subjects in 33 CFR Part 165
■
khammond on DSKBBV9HB2PROD with RULES
Dated: June 11, 2019.
A.M. Beach,
Captain, U.S. Coast Guard, Captain of the
Port Sector Ohio Valley.
This regulation establishes an
exemption from the requirement of a
tolerance for residues of 24epibrassinolide in or on all food
commodities when used in accordance
with label directions and good
agricultural practices. Suntton
International Inc., 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 24epibrassinolide under FFDCA.
DATES: This regulation is effective June
17, 2019. Objections and requests for
hearings must be received on or before
August 16, 2019, 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–2017–0487, 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,
PO 00000
Frm 00060
Fmt 4700
Sfmt 4700
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(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–2017–0487 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 16, 2019. 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
E:\FR\FM\17JNR1.SGM
17JNR1
Federal Register / Vol. 84, No. 116 / Monday, June 17, 2019 / Rules and Regulations
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2017–0487, 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, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Background
In the Federal Register of December
15, 2017 (82 FR 59604) (FRL–9970–50),
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 7F8599)
by Suntton International Inc., 901 H St.,
Suite 610, Sacramento, CA 95814. The
petition requested that 40 CFR part 180
be amended by establishing an
exemption from the requirement of a
tolerance for residues of 24epibrassinolide in or on all food
commodities. That document referenced
a summary of the petition prepared by
the petitioner Suntton International Inc.,
which is available in the docket via
https://www.regulations.gov. There were
no comments received in response to
the notice of filing.
III. Final Rule
khammond on DSKBBV9HB2PROD with RULES
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
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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 24-epibrassinolide
and considered its validity,
completeness, and reliability, as well as
the relationship of this information to
human risk. EPA also considered
available information concerning the
variability of the sensitivities of major
identifiable subgroups of consumers,
including infants and children.
24-epibrassinolide (24-Epi) is a
naturally occurring brassinosteroid,
which belongs to a class of plant steroid
hormones. 24-epibrassinolide has been
recently found to regulate seed
germination, seedling growth, root
development, and photosynthesis, and
to enhance immune response against
biotic and abiotic stressors. Like other
brassinosteroids, 24-epibrassinolide is
ubiquitously distributed in the plant
kingdom at low concentrations in a
variety of plant organs, including
pollens, anthers, seeds, leaves, stems,
roots, flowers and grains, and as a
result, humans are exposed to this
substance.
As a pesticide, 24-epibrassinolide is a
synthetically produced brassinosteroid
that is structurally similar to naturally
occuring brassinsteroids and that is
intended for use as a plant growth
regulator (PGR) to improve crop quality
and yield by promoting plant growth,
defense, and development. Based on
proposed label application rates, 24epibrassinolide is applied at low
concentrations, which is typical of a
PGR.
Based on the data submitted in
support of this petition and the
comprehensive risk assessment
conducted by the Agency (included in
the Docket for this action), EPA
concludes that there is a reasonable
certainty that no harm will result to the
U.S. population, including infants and
children, from aggregate exposures to
PO 00000
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27967
24-epibrassinolide, including dietary
exposures from the consumption of food
treated with this active ingredient in
accordance with label directions and
good agricultural practices, or food
containing naturally occurring residues
of 24-epibrassinolide, residues in
drinking water, and other nonoccupational exposures. EPA has made
this determination because available
toxicology data indicate that the active
ingredient is not acutely toxic and,
based upon a weight of the evidence
(WOE) approach, it has been determined
not to be a developmental toxicant, a
mutagen, or toxic via repeat oral
exposure (i.e. not subchronically toxic
via the oral route). As such the Agency
has not identified any endpoints of
concern for 24-epibrassinolide and has
conducted a qualitative assessment of
exposure. The Agency has determined
that residues of 24-epibrassinolide in
drinking water are expected to be
negligible since significant residues are
not expected due to low application
rates and currently proposed use
patterns. Non-occupational exposures
are anticipated because 24epibrassinolide may be used in
residential settings, such as turf,
however, no toxicological endpoints
have been identified. Therefore, a
residential assessment was not
conducted for 24-epibrassinolide. An
explanation of the data upon which EPA
relied and its risk assessment based on
those data can be found within the April
15, 2019, document entitled ‘‘Federal
Food, Drug, and Cosmetic Act (FFDCA)
Safety Assessment for 24epibrassinolide.’’ This document, as
well as other relevant information, is
available in the docket for this action as
described under ADDRESSES.
Based on its safety determination,
EPA is establishing an exemption from
the requirement of a tolerance for
residues of 24-epibrassinolide.
B. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes due to lack of
concern for exposures, which supports
the establishment of an exemption for
residues of 24-epibrassinolide.
IV. Statutory and Executive Order
Reviews
This action establishes 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
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khammond on DSKBBV9HB2PROD with RULES
27968
Federal Register / Vol. 84, No. 116 / Monday, June 17, 2019 / Rules and Regulations
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 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 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
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Jkt 247001
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
DATES:
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).
FOR FURTHER INFORMATION CONTACT:
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 4, 2019.
Richard Keigwin,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1366 to subpart D to read
as follows:
■
§ 180.1366 24-Epibrassinolide; exemption
from the requirement of a tolerance.
Residues of the plant growth regulator
24-epibrassinolide in or on all food
commodities are exempt from the
requirement of a tolerance, when used
in accordance with label directions and
good agricultural practices.
[FR Doc. 2019–12743 Filed 6–14–19; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Parts 22 and 32
RIN 0906–AB20
Removing Outdated Regulations
Regarding the National Hansen’s
Disease Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Final rule.
AGENCY:
This action removes the
outmoded HHS regulations for the
National Hansen’s Disease Program
(NHDP). Due to superseding events and
statutory changes, NHDP’s regulations
are obsolete.
SUMMARY:
PO 00000
Frm 00062
Fmt 4700
Sfmt 4700
This action is effective July 17,
2019.
Jeri
Pickett, Director, Division of National
Hansen’s Disease Programs, 1770
Physicians Park Drive, Baton Rouge,
Louisiana 70816, by phone at (225) 756–
3774, or by email at jpickett@hrsa.gov.
SUPPLEMENTARY INFORMATION: In
response to Executive Order 13563,
Section 6(a), which urges agencies to
repeal existing regulations that are
outmoded from the Code of Federal
Regulations (CFR), HHS is removing 42
CFR 22.1 and 42 CFR part 32. HHS
believes that there is good cause to
bypass notice and comment and
proceed to a final rule, pursuant to 5
U.S.C. 553(b)(B). The action is noncontroversial, as it merely removes
obsolete provisions from the CFR. This
rule poses no new substantive
requirements on the public. Thus, we
view notice and comment as
unnecessary.
Background
Regulations pertaining to the NHDP
appear at 42 CFR 22.1, ‘‘Hansen’s
Disease Duty by Personnel Other than
Commissioned Officers’’ and 42 CFR
part 32, ‘‘Medical Care for Persons with
Hansen’s Disease and Other Persons in
Emergencies.’’ The NHDP regulation at
Part 22.1 was originally published at 50
FR 43146 (October 24, 1985) and was
superseded by the Consolidated
Omnibus Budget Reconciliation Act of
1985 (COBRA), Public Law 99–272
(April 7, 1986). The NHDP regulations
under Part 32 were originally published
at 40 FR 25816 (June 19, 1975), and later
amended by 40 FR 36774 (August 22,
1975), 46 FR 51918 (October 23, 1981),
and 48 FR 10318 (March 11, 1983). The
NHDP authorizing statute was
substantially amended after these
regulations were promulgated. See 42
U.S.C. 247e; Public Law 105–78 (Nov.
13, 1997), amended by Public Law 107–
220 (Aug. 21, 2002).
For the reasons indicated below, the
regulations at 42 CFR 22.1 and 42 CFR
part 32 are outdated, unnecessary, and/
or redundant. First, as noted above,
Section 22.1 was superseded by Public
Law 99–272. Second, Part 32 references
a Public Health Service Hospital in
Carville, Louisiana, but there is no
longer a Public Health Services Hospital
in Carville, Louisiana. See 42 CFR 32.86
–.87. Third, section 32.1 references ‘‘the
Director, Bureau of Health Care Delivery
and Assistance.’’ This Bureau no longer
exists at HRSA, and other terms set forth
in section 32.1 are defined elsewhere in
the Public Health Service Act. See 42
U.S.C. 201. Fourth, the NHDP
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Agencies
[Federal Register Volume 84, Number 116 (Monday, June 17, 2019)]
[Rules and Regulations]
[Pages 27966-27968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12743]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0487; FRL-9993-15]
24-Epibrassinolide; 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 24-epibrassinolide in or on all food
commodities when used in accordance with label directions and good
agricultural practices. Suntton International Inc., 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 24-epibrassinolide under FFDCA.
DATES: This regulation is effective June 17, 2019. Objections and
requests for hearings must be received on or before August 16, 2019,
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-2017-0487, 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(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-2017-0487 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 16, 2019. 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
[[Page 27967]]
notice. Submit the non-CBI copy of your objection or hearing request,
identified by docket ID number EPA-HQ-OPP-2017-0487, 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, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
II. Background
In the Federal Register of December 15, 2017 (82 FR 59604) (FRL-
9970-50), 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 7F8599) by Suntton International Inc., 901 H St., Suite
610, Sacramento, CA 95814. The petition requested that 40 CFR part 180
be amended by establishing an exemption from the requirement of a
tolerance for residues of 24-epibrassinolide in or on all food
commodities. That document referenced a summary of the petition
prepared by the petitioner Suntton International Inc., which is
available in the docket via https://www.regulations.gov. There were no
comments received in response to the notice of filing.
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 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 24-
epibrassinolide and considered its validity, completeness, and
reliability, as well as the relationship of this information to human
risk. EPA also considered available information concerning the
variability of the sensitivities of major identifiable subgroups of
consumers, including infants and children.
24-epibrassinolide (24-Epi) is a naturally occurring
brassinosteroid, which belongs to a class of plant steroid hormones.
24-epibrassinolide has been recently found to regulate seed
germination, seedling growth, root development, and photosynthesis, and
to enhance immune response against biotic and abiotic stressors. Like
other brassinosteroids, 24-epibrassinolide is ubiquitously distributed
in the plant kingdom at low concentrations in a variety of plant
organs, including pollens, anthers, seeds, leaves, stems, roots,
flowers and grains, and as a result, humans are exposed to this
substance.
As a pesticide, 24-epibrassinolide is a synthetically produced
brassinosteroid that is structurally similar to naturally occuring
brassinsteroids and that is intended for use as a plant growth
regulator (PGR) to improve crop quality and yield by promoting plant
growth, defense, and development. Based on proposed label application
rates, 24-epibrassinolide is applied at low concentrations, which is
typical of a PGR.
Based on the data submitted in support of this petition and the
comprehensive risk assessment conducted by the Agency (included in the
Docket for this action), EPA concludes that there is a reasonable
certainty that no harm will result to the U.S. population, including
infants and children, from aggregate exposures to 24-epibrassinolide,
including dietary exposures from the consumption of food treated with
this active ingredient in accordance with label directions and good
agricultural practices, or food containing naturally occurring residues
of 24-epibrassinolide, residues in drinking water, and other non-
occupational exposures. EPA has made this determination because
available toxicology data indicate that the active ingredient is not
acutely toxic and, based upon a weight of the evidence (WOE) approach,
it has been determined not to be a developmental toxicant, a mutagen,
or toxic via repeat oral exposure (i.e. not subchronically toxic via
the oral route). As such the Agency has not identified any endpoints of
concern for 24-epibrassinolide and has conducted a qualitative
assessment of exposure. The Agency has determined that residues of 24-
epibrassinolide in drinking water are expected to be negligible since
significant residues are not expected due to low application rates and
currently proposed use patterns. Non-occupational exposures are
anticipated because 24-epibrassinolide may be used in residential
settings, such as turf, however, no toxicological endpoints have been
identified. Therefore, a residential assessment was not conducted for
24-epibrassinolide. An explanation of the data upon which EPA relied
and its risk assessment based on those data can be found within the
April 15, 2019, document entitled ``Federal Food, Drug, and Cosmetic
Act (FFDCA) Safety Assessment for 24-epibrassinolide.'' This document,
as well as other relevant information, is available in the docket for
this action as described under ADDRESSES.
Based on its safety determination, EPA is establishing an exemption
from the requirement of a tolerance for residues of 24-epibrassinolide.
B. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes due
to lack of concern for exposures, which supports the establishment of
an exemption for residues of 24-epibrassinolide.
IV. Statutory and Executive Order Reviews
This action establishes 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
[[Page 27968]]
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 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
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 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 4, 2019.
Richard Keigwin,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Add Sec. 180.1366 to subpart D to read as follows:
Sec. 180.1366 24-Epibrassinolide; exemption from the requirement of a
tolerance.
Residues of the plant growth regulator 24-epibrassinolide in or on
all food commodities are exempt from the requirement of a tolerance,
when used in accordance with label directions and good agricultural
practices.
[FR Doc. 2019-12743 Filed 6-14-19; 8:45 am]
BILLING CODE 6560-50-P