Sethoxydim; Pesticide Tolerances, 77999-78002 [2020-26014]
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Federal Register / Vol. 85, No. 233 / Thursday, December 3, 2020 / Rules and Regulations
77999
TABLE 4 TO PARAGRAPH (a)(5)(ii)—NEGATIVE DECLARATIONS FOR THE 2008 OZONE NAAQS—Continued
CTG document No.
CTG document title
EPA–450/2–77–033 .......
Control of Volatile Organic Emissions from Existing Stationary Sources—Volume IV: Surface Coating of Insulation of
Magnet Wire.
Control of Volatile Organic Emissions from Existing Stationary Sources—Volume V: Surface Coating of Large Appliances.
Control of Volatile Organic Emissions from Manufacture of Pneumatic Rubber Tires.
Control of Volatile Organic Emissions from Existing Stationary Sources—Volume VII: Factory Surface Coating of Flat
Wood Paneling.
Control of Volatile Organic Compound Leaks from Petroleum Refinery Equipment.
Control of Volatile Organic Compound Emissions from Large Petroleum Dry Cleaners.
Control of Volatile Organic Compound Leaks from Synthetic Organic Chemical Polymer and Resin Manufacturing
Equipment.
Control of Volatile Organic Compound Equipment Leaks from Natural Gas/Gasoline Processing Plants.
Control of Volatile Organic Compound Emissions from Manufacture of High-Density Polyethylene, Polypropylene, and
Polystyrene Resins.
Control of Volatile Organic Compound Emissions from Air Oxidation Processes in Synthetic Organic Chemical Manufacturing Industry.
Control of Volatile Organic Compound Emissions from Reactor Processes and Distillation Operations in Synthetic Organic Chemical Manufacturing Industry.
Control of Volatile Organic Compound Emissions from Coating Operations at Aerospace Manufacturing and Rework
Operations; Aerospace MACT.
Control Techniques Guidelines for Flat Wood Paneling Coatings.
Control Techniques Guidelines for Large Appliance Coatings.
Control Techniques Guidelines for Metal Furniture Coatings.
Control Techniques Guidelines for Automobile and Light-Duty Truck Assembly Coatings.
EPA–450/2–77–034 .......
EPA–450/2–78–030 .......
EPA–450/2–78–032 .......
EPA–450/2–78–036 .......
EPA–450/3–82–009 .......
EPA–450/3–83–006 .......
EPA–450/3–83–007 .......
EPA–450/3–83–008 .......
EPA–450/3–84–015 .......
EPA–450/4–91–031 .......
EPA–453/R–97–004; 59
FR 29216 (6/6/94).
EPA–453/R–06–004 ......
EPA–453/R–07–004 ......
EPA–453/R–07–005 ......
EPA–453/R–08–006 ......
*
*
*
*
*
4. Section 52.237 is amended by
adding paragraph (b)(2) to read as
follows:
ENVIRONMENTAL PROTECTION
AGENCY
■
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§ 52.237
40 CFR Part 180
[EPA–HQ–OPP–2019–0461; FRL–10016–23]
Part D disapproval.
(b) * * *
(2) San Diego Air Pollution Control
District.
(i) RACT determinations for the
following source categories in the
submittal titled ‘‘2008 Eight-Hour Ozone
Reasonably Available Control
Technology Demonstration for San
Diego County,’’ dated December 2016,
as adopted December 14, 2016, and
submitted on April 12, 2017.
(A) Design Criteria for Stage I Vapor
Control Systems—Gasoline Service
Stations (EPA–450/R–75–102).
(B) Tank Truck Gasoline Loading
Terminals (EPA–450/2–77–026).
(C) Manufacture of Synthesized
Pharmaceutical Products (EPA–450/2–
78–029).
(D) Industrial Cleaning Solvents
(EPA–453/R–06–001).
(E) Fiberglass Boat Manufacturing
Materials (EPA–453/R–08–004).
(F) Non-CTG major sources of VOC.
(G) Miscellaneous Metal and Plastic
Parts Coatings (EPA–453/R–08–003)
Table 3—Plastic Parts and Products,
Table 4—Automotive/Transportation
and Business Machine Plastic Parts,
Table 5—Pleasure Craft Surface Coating,
and Table 6—Motor Vehicle Materials.
(ii) [Reserved]
[FR Doc. 2020–26649 Filed 12–2–20; 8:45 am]
BILLING CODE 6560–50–P
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Sethoxydim; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of sethoxydim in
or on basil, dried leaves and basil, fresh
leaves. Interregional Research Project
Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
December 3, 2020. Objections and
requests for hearings must be received
on or before February 1, 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–2019–0461, 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
SUMMARY:
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Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805.
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.
FOR FURTHER INFORMATION CONTACT:
Marietta Echeverria, Registration
Division (7505P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
telephone number: (703) 305–7090;
email address: RDFRNotices@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).
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Federal Register / Vol. 85, No. 233 / Thursday, December 3, 2020 / Rules and Regulations
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Publishing Office’s eCFR 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–2019–0461 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing and must be received
by the Hearing Clerk on or before
February 1, 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–
2019–0461, 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
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15:55 Dec 02, 2020
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available at https://www.epa.gov/
dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of October 3,
2019 (84 FR 52850) (FRL–9999–89),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 9E8769) by IR–4,
IR–4 Project Headquarters, Rutgers, The
State University of New Jersey, 500
College Road East, Suite 201 W,
Princeton, NJ 08540. The petition
requested that 40 CFR 180.412 be
amended by establishing tolerances for
residues of the herbicide sethoxydim,
including its metabolites and
degradates, determined by measuring
only the sum of sethoxydim, 2-[1(ethoxyimino)butyl]-5-[2(ethylthio)propyl]-3-hydroxy-2cyclohexen-1-one (CAS Reg. No. 74051–
80–2) and its metabolites containing the
2-cyclohexen-1-one moiety, calculated
as the stoichiometric equivalent of
sethoxydim, in or on basil, dried leaves
at 20 parts per million (ppm) and basil,
fresh leaves at 8 ppm. That document
referenced a summary of the petition
prepared by IR–4, the petitioner, which
is available in the docket for this action,
docket ID number EPA–HQ–OPP–2019–
0461, at https://www.regulations.gov. No
relevant comments were received in
response to the notice of filing.
III. Aggregate Risk Assessment and
Determination of Safety
A. Statutory Background
Section 408(b)(2)(A)(i) of the FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(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 it does not
include occupational exposure. Section
408(b)(2)(C) of FFDCA requires 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. . . .’’
Consistent with FFDCA section
408(b)(2)(D), EPA has reviewed the
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available scientific data and other
relevant information in support of this
action. EPA has sufficient data to assess
the hazards of sethoxydim and to make
a determination on aggregate exposure
for sethoxydim, including exposure
resulting from the tolerances established
by this action. EPA’s assessment of
exposures and risks associated with
sethoxydim follows.
B. Sethoxydim Aggregate Risk
Assessment
On June 15, 2015, EPA published in
the Federal Register a final rule
establishing tolerances for residues of
sethoxydim in or on multiple
commodities based on the Agency’s
conclusion that aggregate exposure to
sethoxydim is safe for the general
population, including infants and
children. See 80 FR 34070 (FRL–9928–
20) (Docket ID EPA–HQ–OPP–2014–
0161). In an effort to streamline Federal
Register publications, EPA is not
reprinting here summaries of its
analysis that have previously appeared
in the Federal Register in tolerance
rulemakings for the same pesticide. To
that end, this rulemaking refers the
reader to the following sections from the
June 15, 2015 tolerance rulemaking for
sethoxydim that remain unchanged for
an understanding of the Agency’s
rationale in support of this rulemaking:
Units III.A (Toxicological Profile); III.B.
(Toxicological Points of Departure/
Levels of Concern); III.C. (Exposure
Assessment), except as explained in the
next paragraphs; III.D. (Safety Factor for
Infants and Children); and IV.A
(Analytical Enforcement Method).
1. Updates to exposure assessment.
EPA’s dietary (food and drinking water)
exposure assessments have been
updated to include the additional
exposure from the new use of
sethoxydim on basil. In addition, the
acute dietary exposure assessment was
revised to: (1) Assume 100% crop
treated, instead of using percent crop
treated as described in the 2015 rule;
and (2) incorporate empirical and/or
EPA’s 2018 default processing factors.
The assumption of tolerance-level
residues for both the acute and chronic
dietary analyses has not changed. For
the chronic dietary exposure
assessment, EPA incorporated updated
average crop treated estimates for select
commodities and EPA’s 2018 processing
factors.
The new use on basil does not impact
drinking water exposures; therefore, the
Agency relied on the same values for
drinking water exposures as expressed
in the June 2015 rulemaking.
While EPA has updated the human
equivalent doses for assessing
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inhalation risk to residential handlers,
this revision does not impact the
approach of the aggregate assessment.
The scenario and life stage resulting in
the highest residential exposures for use
in the aggregate assessment and which
is considered protective of other
exposure scenarios continues to be the
post-application incidental oral hand-tomouth exposure of children (1 to less
than 2 years old) on treated turf. The
new use on basil does not result in any
additional residential exposures.
2. Assessment of aggregate risks. EPA
determines whether acute and chronic
dietary pesticide exposures are safe by
comparing aggregate exposure estimates
to the acute population adjusted dose
and chronic population adjusted dose.
Short-, intermediate-, and chronic-term
risks are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
points of departure to ensure that an
adequate margin of exposure (MOE)
exists. For linear cancer risks, EPA
calculates the lifetime probability of
acquiring cancer given the estimated
aggregate exposure.
Acute dietary (food and drinking
water) risks are below the Agency’s
level of concern of 100% of the acute
population adjusted dose (aPAD): They
are less than 12% of the aPAD for
children 1 to 2 years old, the population
subgroup with the highest exposure
estimate. Chronic dietary risks are
below the Agency’s level of concern of
100% of the chronic population
adjusted dose (cPAD): They are 24% of
the cPAD for children 1 to 2 years old,
the population subgroup with the
highest exposure estimate.
For the aggregate risk assessment,
exposures to sethoxydim in food and
drinking water are combined with
residential exposures for the relevant
exposure duration period. Aggregate
acute and chronic risk are equivalent to
the dietary risks, which are below EPA’s
level of concern, because neither acute
nor long-term residential exposures are
expected.
The short-term aggregate risk
assessment considers only residential
incidental oral exposures and combines
chronic (background) exposures with
the expected short-term post-application
exposures to children 1 to 2 years old.
This yields an MOE of 4,400, which is
not of concern because it exceeds EPA’s
level of concern (MOEs less than or
equal to 100). Intermediate-term
residential exposures are not expected.
Finally, as stated in the June 2015
rulemaking, sethoxydim is not expected
to pose a cancer risk to humans.
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C. Determination of Safety
Therefore, based on the risk
assessments and information described
and referenced above, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children,
from aggregate exposure to sethoxydim
residues. More detailed information
about the Agency’s analysis can be
found in ‘‘Sethoxydim: Human Health
Risk Assessment to Support the Section
3 Use on Basil and a Label Amendment
to Reduce the Pre-harvest Interval for
Caneberry Subgroup 13–07A’’ dated
October 21, 2020 in docket ID number
EPA–HQ–OPP–2019–0461.
IV. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex has not established a MRL
for sethoxydim.
V. Conclusion
Therefore, tolerances are established
for residues of sethoxydim, including its
metabolites and degradates, determined
by measuring only the sum of the
herbicide 2-[1-(ethoxyimino)butyl]-5-[2(ethylthio)propyl]-3-hydroxy-2cyclohexen-1-one (CAS Reg. No. 74051–
80–2) and its metabolites containing the
2-cyclohexen-1-one moiety, calculated
as the stoichiometric equivalent of
sethoxydim, in or on basil, dried leaves
at 20 ppm and basil, fresh leaves at 8
ppm.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
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
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78001
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 tolerances 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).
VII. 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
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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: November 5, 2020.
Marietta Echeverria,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.412, amend paragraph (a)
by designating the table and adding in
alphabetical order in newly designated
Table 1 to paragraph (a) the entries
‘‘Basil, dried leaves’’ and ‘‘Basil, fresh
leaves’’ to read as follows:
■
§ 180.412 Sethoxydim; tolerances for
residues.
(a) * * *
TABLE 1 TO PARAGRAPH (a)
Parts per
million
Commodity
*
*
*
*
*
Basil, dried leaves ......................
Basil, fresh leaves ......................
*
*
*
*
*
*
*
*
20
8
*
*
[FR Doc. 2020–26014 Filed 12–2–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
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40 CFR Part 180
Adipic Acid; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
15:55 Dec 02, 2020
I. General Information
DATES:
This regulation is effective
December 3, 2020. Objections and
requests for hearings must be received
on or before February 1, 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).
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.
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2019–0569, 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.
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.
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–2019–0569 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing and must be received
by the Hearing Clerk on or before
February 1, 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–
2019–0569, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
[EPA–HQ–OPP–2019–0569; FRL–10015–57]
VerDate Sep<11>2014
This regulation establishes an
exemption from the requirement of a
tolerance for residues of Adipic acid
when used as an inert ingredient in
antimicrobial pesticide formulations
applied to food-contact surfaces in
public eating places, dairy-processing
equipment, and food-processing
equipment and utensils at an end-use
concentration not to exceed 100 parts
per million (ppm). Ecolab, Inc.
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA) requesting establishment of an
exemption from the requirement of a
tolerance for adipic acid. This
regulation eliminates the need to
establish a maximum permissible level
for residues of adipic acid when used in
accordance with this exemption.
SUMMARY:
Jkt 253001
Marietta Echeverria, Registration
Division (7505P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
telephone number: (703) 305–7090;
email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
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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).
E:\FR\FM\03DER1.SGM
03DER1
]]>Agencies
[Federal Register Volume 85, Number 233 (Thursday, December 3, 2020)]
[Rules and Regulations]
[Pages 77999-78002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26014]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0461; FRL-10016-23]
Sethoxydim; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
sethoxydim in or on basil, dried leaves and basil, fresh leaves.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective December 3, 2020. Objections and
requests for hearings must be received on or before February 1, 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-2019-0461, 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.
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.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), 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).
[[Page 78000]]
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 EPA's
tolerance regulations at 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-2019-0461 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
February 1, 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-2019-0461, 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. Summary of Petitioned-For Tolerance
In the Federal Register of October 3, 2019 (84 FR 52850) (FRL-9999-
89), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
9E8769) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition requested that 40 CFR 180.412 be
amended by establishing tolerances for residues of the herbicide
sethoxydim, including its metabolites and degradates, determined by
measuring only the sum of sethoxydim, 2-[1-(ethoxyimino)butyl]-5-[2-
(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one (CAS Reg. No. 74051-80-
2) and its metabolites containing the 2-cyclohexen-1-one moiety,
calculated as the stoichiometric equivalent of sethoxydim, in or on
basil, dried leaves at 20 parts per million (ppm) and basil, fresh
leaves at 8 ppm. That document referenced a summary of the petition
prepared by IR-4, the petitioner, which is available in the docket for
this action, docket ID number EPA-HQ-OPP-2019-0461, at https://www.regulations.gov. No relevant comments were received in response to
the notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
A. Statutory Background
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(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 it does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires 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. . .
.''
Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
sethoxydim and to make a determination on aggregate exposure for
sethoxydim, including exposure resulting from the tolerances
established by this action. EPA's assessment of exposures and risks
associated with sethoxydim follows.
B. Sethoxydim Aggregate Risk Assessment
On June 15, 2015, EPA published in the Federal Register a final
rule establishing tolerances for residues of sethoxydim in or on
multiple commodities based on the Agency's conclusion that aggregate
exposure to sethoxydim is safe for the general population, including
infants and children. See 80 FR 34070 (FRL-9928-20) (Docket ID EPA-HQ-
OPP-2014-0161). In an effort to streamline Federal Register
publications, EPA is not reprinting here summaries of its analysis that
have previously appeared in the Federal Register in tolerance
rulemakings for the same pesticide. To that end, this rulemaking refers
the reader to the following sections from the June 15, 2015 tolerance
rulemaking for sethoxydim that remain unchanged for an understanding of
the Agency's rationale in support of this rulemaking: Units III.A
(Toxicological Profile); III.B. (Toxicological Points of Departure/
Levels of Concern); III.C. (Exposure Assessment), except as explained
in the next paragraphs; III.D. (Safety Factor for Infants and
Children); and IV.A (Analytical Enforcement Method).
1. Updates to exposure assessment. EPA's dietary (food and drinking
water) exposure assessments have been updated to include the additional
exposure from the new use of sethoxydim on basil. In addition, the
acute dietary exposure assessment was revised to: (1) Assume 100% crop
treated, instead of using percent crop treated as described in the 2015
rule; and (2) incorporate empirical and/or EPA's 2018 default
processing factors. The assumption of tolerance-level residues for both
the acute and chronic dietary analyses has not changed. For the chronic
dietary exposure assessment, EPA incorporated updated average crop
treated estimates for select commodities and EPA's 2018 processing
factors.
The new use on basil does not impact drinking water exposures;
therefore, the Agency relied on the same values for drinking water
exposures as expressed in the June 2015 rulemaking.
While EPA has updated the human equivalent doses for assessing
[[Page 78001]]
inhalation risk to residential handlers, this revision does not impact
the approach of the aggregate assessment. The scenario and life stage
resulting in the highest residential exposures for use in the aggregate
assessment and which is considered protective of other exposure
scenarios continues to be the post-application incidental oral hand-to-
mouth exposure of children (1 to less than 2 years old) on treated
turf. The new use on basil does not result in any additional
residential exposures.
2. Assessment of aggregate risks. EPA determines whether acute and
chronic dietary pesticide exposures are safe by comparing aggregate
exposure estimates to the acute population adjusted dose and chronic
population adjusted dose. Short-, intermediate-, and chronic-term risks
are evaluated by comparing the estimated aggregate food, water, and
residential exposure to the appropriate points of departure to ensure
that an adequate margin of exposure (MOE) exists. For linear cancer
risks, EPA calculates the lifetime probability of acquiring cancer
given the estimated aggregate exposure.
Acute dietary (food and drinking water) risks are below the
Agency's level of concern of 100% of the acute population adjusted dose
(aPAD): They are less than 12% of the aPAD for children 1 to 2 years
old, the population subgroup with the highest exposure estimate.
Chronic dietary risks are below the Agency's level of concern of 100%
of the chronic population adjusted dose (cPAD): They are 24% of the
cPAD for children 1 to 2 years old, the population subgroup with the
highest exposure estimate.
For the aggregate risk assessment, exposures to sethoxydim in food
and drinking water are combined with residential exposures for the
relevant exposure duration period. Aggregate acute and chronic risk are
equivalent to the dietary risks, which are below EPA's level of
concern, because neither acute nor long-term residential exposures are
expected.
The short-term aggregate risk assessment considers only residential
incidental oral exposures and combines chronic (background) exposures
with the expected short-term post-application exposures to children 1
to 2 years old. This yields an MOE of 4,400, which is not of concern
because it exceeds EPA's level of concern (MOEs less than or equal to
100). Intermediate-term residential exposures are not expected.
Finally, as stated in the June 2015 rulemaking, sethoxydim is not
expected to pose a cancer risk to humans.
C. Determination of Safety
Therefore, based on the risk assessments and information described
and referenced above, EPA concludes that there is a reasonable
certainty that no harm will result to the general population, or to
infants and children, from aggregate exposure to sethoxydim residues.
More detailed information about the Agency's analysis can be found in
``Sethoxydim: Human Health Risk Assessment to Support the Section 3 Use
on Basil and a Label Amendment to Reduce the Pre-harvest Interval for
Caneberry Subgroup 13-07A'' dated October 21, 2020 in docket ID number
EPA-HQ-OPP-2019-0461.
IV. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4).
The Codex has not established a MRL for sethoxydim.
V. Conclusion
Therefore, tolerances are established for residues of sethoxydim,
including its metabolites and degradates, determined by measuring only
the sum of the herbicide 2-[1-(ethoxyimino)butyl]-5-[2-
(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one (CAS Reg. No. 74051-80-
2) and its metabolites containing the 2-cyclohexen-1-one moiety,
calculated as the stoichiometric equivalent of sethoxydim, in or on
basil, dried leaves at 20 ppm and basil, fresh leaves at 8 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances 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 tolerances 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).
VII. 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
[[Page 78002]]
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: November 5, 2020.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
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. In Sec. 180.412, amend paragraph (a) by designating the table and
adding in alphabetical order in newly designated Table 1 to paragraph
(a) the entries ``Basil, dried leaves'' and ``Basil, fresh leaves'' to
read as follows:
Sec. 180.412 Sethoxydim; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Basil, dried leaves......................................... 20
Basil, fresh leaves......................................... 8
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2020-26014 Filed 12-2-20; 8:45 am]
BILLING CODE 6560-50-P
