S-metolachlor; Pesticide Tolerances, 40128-40131 [2020-14393]
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40128
Federal Register / Vol. 85, No. 129 / Monday, July 6, 2020 / Rules and Regulations
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 temporary 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).
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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: May 28, 2020.
Robert McNally,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
Therefore, for the reasons stated in the
preamble, EPA amends 40 CFR chapter
I 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 § 180.711 to subpart C to read
as follows:
■
§ 180.711 1-Aminocyclopropane-1carboxylic acid (ACC); temporary
exemption from the requirement of a
tolerance for residues.
A temporary exemption from the
requirement of a tolerance is established
for residues of the plant growth
regulator, 1-Aminocyclopropane-1carboxylic acid (ACC) in or on apples
and stone fruits when used in
accordance with the terms of the
Experimental Use Permit (EUP) under
EPA Number 73049–EUP–12. This
temporary exemption expires on July 6,
2023.
[FR Doc. 2020–12143 Filed 7–2–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2019–0652 and EPA–HQ–
OPP–2020–0047; FRL–10011–10]
S-metolachlor; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of S-metolachlor
SUMMARY:
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The dockets for this action,
identified by docket identification (ID)
numbers EPA–HQ–OPP–2019–0652 and
EPA–HQ–OPP–2020–0047, are 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 note that due to the public
health emergency, the EPA Docket
Center (EPA/DC) and Reading Room
was closed to public visitors on March
31, 2020. Our EPA/DC staff will
continue to provide customer service
via email, phone, and webform. For
further information on EPA/DC services,
docket contact information and the
current status of the EPA/DC and
Reading Room, please visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, 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:
ADDRESSES:
I. General Information
40 CFR Part 180
PO 00000
in or on multiple commodities which
are identified and discussed later in this
document. The Interregional Project
Number 4 (IR–4) and Syngenta Crop
Protection, LLC requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July
6, 2020. Objections and requests for
hearings must be received on or before
September 4, 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).
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
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Federal Register / Vol. 85, No. 129 / Monday, July 6, 2020 / Rules and Regulations
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 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 numbers EPA–HQ–
OPP–2019–0652 and EPA–HQ–OPP–
2020–0047 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
September 4, 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 numbers EPA–HQ–OPP–
2019–0652 and EPA–HQ–OPP–2020–
0047, 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
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delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/where-sendcomments-epa-dockets. Additional
instructions on commenting or visiting
the docket, along with more information
about dockets generally, is available at
https://www.epa.gov/dockets.
Based upon review of the data
supporting the petition, EPA is
establishing several tolerances at
different levels than petitioned-for
tolerances and revised the commodity
definitions for grain, aspirated fractions
and soybean, seed. The reasons for these
changes are explained in Unit IV.D.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of May 8, 2020
(85 FR 27346) (FRL–10008–38), 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 9E8800) by IR–4, Rutgers,
the State University of New Jersey, 500
College Road East, Suite 201 W,
Princeton, NJ 08540. The petition
requested that 40 CFR 180.368(a)(2) be
amended by establishing tolerances for
residues of the herbicide S-metolachlor,
S–2-chloro-N-(2-ethyl-6-methylphenyl)N-(2-methoxy-1-methylethyl)acetamide,
its R-enantiomer, and its metabolites,
determined as the derivatives, 2-(2ethyl-6-methylphenyl)amino-1-propanol
and 4-(2-ethyl-6-methylphenyl)-2hydroxy-5-methyl-3-morpholinone,
calculated as the stoichiometric
equivalent of S-metolachlor, in or on
Dillweed at 5 parts per million (ppm);
Dillweed, dried leaves at 9 ppm; Dill,
seed at 15 ppm; Rosemary, dried leaves
at 2 ppm and Rosemary, fresh leaves 1.5
ppm. One comment was received on the
notice of filing. EPA’s response to this
comment is discussed in Unit IV.C.
In the Federal Register of March 3,
2020 (85 FR 12454) (FRL–10005–58),
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 9F8764) by
Syngenta Crop Protection, LLC., P.O.
Box 18300, Greensboro, NC 27419. The
petition requested that 40 CFR
180.368(a)(2) be amended by revising
the tolerances for residues of the
herbicide S-metolachlor, S–2-chloro-N(2-ethyl-6-methylphenyl)-N-(2-methoxy1-methylethyl)acetamide, its Renantiomer, and its metabolites,
determined as the derivatives, 2-(2ethyl-6-methylphenyl)amino-1-propanol
and 4-(2-ethyl-6-methylphenyl)-2hydroxy-5-methyl-3-morpholinone,
calculated as the stoichiometric
equivalent of S-metolachlor, in or on
soybean seed to be 1.0 ppm and grain,
aspirated fractions to be 2.0 ppm. That
document referenced a summary of the
petition prepared by Syngenta Crop
Protection, LLC., the registrant, which is
available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of 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 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), and the factors specified in
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
and to make a determination on
aggregate exposure for S-metolachlor
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with S-metolachlor follows.
On March 11, 2019, EPA published in
the Federal Register a final rule
establishing tolerances for residues of Smetolachlor in or on several
commodities based on the Agency’s
conclusion that aggregate exposure to Smetolachlor is safe for the general
population, including infants and
children. See (84 FR 8611) (FRL–9983–
79). EPA is incorporating the following
portions of that document by reference
here, as they have not changed in the
Agency’s current assessment of Smetolachlor tolerances: The
toxicological profile and points of
departure, the cancer assessment and
conclusion that a nonlinear reference
dose (RfD) approach is appropriate for
assessing cancer risk, the conclusions
about cumulative risk, and the Agency’s
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Federal Register / Vol. 85, No. 129 / Monday, July 6, 2020 / Rules and Regulations
determination regarding the children’s
safety factor. Additionally, EPA is
incorporating the assumptions for
exposure assessment from the March 11,
2019 final rule, which have not changed
except as explained in the following
paragraph.
EPA’s dietary (food and drinking
water) exposure assessments have been
updated to include the additional
exposure from the new uses of Smetolachlor on dill and rosemary and
the revised use on soybean. EPA
conducted an unrefined chronic dietary
(food and drinking water) exposure and
risk assessment that incorporates
tolerance-level residue values, 100%
crop treated, and EPA’s 2018 default
processing factors.
The estimated drinking water
concentrations (EDWCs) of Smetolachlor and its metabolites for
chronic exposures have also been
updated; the new value used for the
chronic assessment to assess the
contribution to drinking water is 830
parts per billion (ppb), which is lower
than the previous value of 978 ppb.
An acute dietary endpoint (i.e., single
dose endpoint) for risk assessment was
not identified in the toxicity database
for the general U.S. population or any
other subpopulation for S-metolachlor;
therefore, an acute dietary exposure
assessment was not conducted. Chronic
dietary risks are below the Agency’s
level of concern of 100% of the chronic
population adjusted dose (cPAD); they
are estimated to be 19% of the cPAD for
all infants less than 1 year old, the
group with the highest exposure.
There are no proposed new
residential uses for S-metolachlor,
although commercial use in residential
areas may result in the following shortterm residential exposures that were
used in the Agency’s aggregate risk
assessment: Post-application dermal
exposures to youth (11 to less than 16
years old) from treated turf, to children
(6 to less than 11 years old) from treated
gardens, and to children (1 to less than
2 years old) from treated turf and postapplication incidental oral exposure to
children (1 to less than 2 years old) from
treated turf.
For aggregate risk assessment,
exposures to S-metolachlor in food and
drinking water are combined with
residential exposures for the relevant
exposure duration period. Because
acute, intermediate-term, or long-term
residential exposures are not expected,
aggregate acute and chronic risk is
equivalent to the dietary risks, which
are below EPA’s level of concern.
Moreover, based on the chronic
exposure assessment, which accounts
for potential carcinogenicity, EPA does
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not expect S-metolachlor to pose a
cancer risk. Short-term aggregate risk,
which combines chronic (background)
exposures with the expected short-term
post-application exposures mentioned
above, yields margins of exposure
(MOEs) ranging from 110 to 1370, which
are not of concern because they exceed
EPA’s level of concern (MOEs less than
or equal to 100).
Therefore, EPA concludes there is a
reasonable certainty that no harm will
result to the general population, or to
infants and children from aggregate
exposure to S-metolachlor residues.
More detailed information can be found
in the document entitled, ‘‘SMetolachlor: Human Health Risk
Assessment for Petition for the
Establishment of Tolerances and
Registration for Use in/on Rosemary and
Dill (PP#9E8800) and Amended Use in/
on Soybean (PP# 9F8764),’’ in docket
IDs EPA–HQ–OPP–2019–0652 and
EPA–HQ–2020–0047.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies
are available in the Pesticide Analytical
Manual (PAM) Vol. II for enforcement of
S-metolachlor crop and livestock
tolerances. Pesticide regulation section
180.368, lists a gas chromatography
with nitrogen-phosphorus detector (GC/
NPD) method (Method I) for
determining residues in/on crop
commodities and a gas chromatography
with mass selective detector (GC/MSD)
method (Method II) for determining
residues in livestock commodities.
These methods determine residues of
metolachlor and its metabolites as either
CGA–37913 or CGA–49751 following
acid hydrolysis.
The methods may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
B. 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 Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
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and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
No maximum residue limits (MRLs)
for S-metolachlor have been established
or proposed by Codex.
C. Response to Comments
There was one comment received on
the notice of filing. The comment stated
that IR–4 is trying to get this chemical
through during a pandemic and without
public notice. The commenter also
stated that this chemical should not be
used on any food products that
American’s eat. In response, EPA notes
the existing legal framework provided
by section 408 of the FFDCA states that
tolerances may be set when persons
seeking such tolerances or exemptions
have demonstrated that the pesticide
meets the safety standard imposed by
that statute. This comment appears to be
directed at the underlying statute and
not EPA’s implementation of it; the
comment provides no information
relevant the Agency’s safety
determination.
D. Revisions to Petitioned-For
Tolerances
The Agency is establishing the
tolerances for grain, aspirated fractions
and soybean, seed at different levels
than the petitioner requested. For grain,
aspirated fractions, EPA calculated the
tolerance level using the highest average
field trial (HAFT) residues in
combination with the median
processing factor from the submitted
soybean data. This results in a tolerance
of 4 ppm rather than the proposed
tolerance of 2.0 ppm. EPA calculated
the tolerance level for soybean, seed
using the HAFT residue values from the
submitted soybean data in the
Organization for Economic Cooperation
and Development (OECD) MRL
calculator. This results in a tolerance of
0.9 ppm rather than the proposed
tolerance of 1.0 ppm. In addition, the
commodity definitions were revised for
grain, aspirated fractions and soybean,
seed. Finally, a tolerance for residues
in/on soybean, meal at 1.5 ppm has
been added by the Agency based on the
submitted soybean data, because the
HAFT residues in combination with the
median processing factor from the
submitted data result in a value higher
than the tolerance level for soybean,
seed.
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V. Conclusion
Therefore, tolerances are established
for residues of S-metolachlor, S-2chloro-N-(2-ethyl-6-methylphenyl)-N-(2methoxy-1-methylethyl)acetamide, its
R-enantiomer, and its metabolites,
determined as the derivatives, 2-(2ethyl-6-methylphenyl)amino-1-propanol
and 4-(2-ethyl-6-methylphenyl)-2hydroxy-5-methyl-3-morpholinone,
calculated as the stoichiometric
equivalent of S-metolachlor in or on
dill, seed at 15 ppm; dillweed at 5 ppm;
dillweed, dried leaves at 9 ppm;
rosemary, dried leaves at 2 ppm;
rosemary, fresh leaves at 1.5 ppm; and
soybean, meal at 1.5 ppm. In addition,
the Agency is increasing the tolerances
for residues of S-metolachlor in or on
grain, aspirated fractions to be 4 ppm
and soybean, seed to be 0.9 ppm.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to petitions 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.
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18:55 Jul 02, 2020
Jkt 250001
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
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.
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.368, paragraph (a)(2):
i. Add a heading to the table.
■ ii. Add alphabetically the entries
‘‘Dill, seed’’; ‘‘Dillweed’’ and ‘‘Dillweed,
dried leaves’’.
■ iii. Revise the entry for ‘‘Grain,
aspirated fractions’’.
■ iv. Add alphabetically the entries
‘‘Rosemary, dried leaves’’; ‘‘Rosemary,
fresh leaves’’ and ‘‘Soybean, meal’’.
■ v. Revise the entry for ‘‘Soybean,
seed’’.
The additions and revisions read as
follows:
■
■
§ 180.368 Metolachlor, tolerances for
residues.
(a) * * *
(2) * * *
TABLE 2 TO PARAGRAPH (a)(2)
*
*
*
*
Dill, seed ...................................
Dillweed ....................................
Dillweed, dried leaves ..............
*
*
Grain, aspirated fractions .........
*
*
Rosemary, dried leaves ............
Rosemary, fresh leaves ............
*
*
4
*
*
Soybean, meal ..........................
Soybean, seed ..........................
*
*
2
1.5
*
*
*
1.5
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[FR Doc. 2020–14393 Filed 7–2–20; 8:45 am]
BILLING CODE 6560–50–P
1. The authority citation for part 180
continues to read as follows:
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PART 180—[AMENDED]
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Therefore, 40 CFR chapter I is
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Frm 00043
Parts per
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Commodity
Dated: June 19, 2020.
Michael Goodis,
Director, Registration Division, Office of
Pesticide Programs.
PO 00000
40131
06JYR1
]]>Agencies
[Federal Register Volume 85, Number 129 (Monday, July 6, 2020)]
[Rules and Regulations]
[Pages 40128-40131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14393]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0652 and EPA-HQ-OPP-2020-0047; FRL-10011-10]
S-metolachlor; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of S-
metolachlor in or on multiple commodities which are identified and
discussed later in this document. The Interregional Project Number 4
(IR-4) and Syngenta Crop Protection, LLC requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July 6, 2020. Objections and
requests for hearings must be received on or before September 4, 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 dockets for this action, identified by docket
identification (ID) numbers EPA-HQ-OPP-2019-0652 and EPA-HQ-OPP-2020-
0047, are 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 note that due to the public health emergency, the EPA Docket
Center (EPA/DC) and Reading Room was closed to public visitors on March
31, 2020. Our EPA/DC staff will continue to provide customer service
via email, phone, and webform. For further information on EPA/DC
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, 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
[[Page 40129]]
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 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 numbers EPA-HQ-OPP-2019-0652 and EPA-HQ-OPP-2020-0047 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 September 4, 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 numbers EPA-HQ-OPP-2019-0652 and EPA-
HQ-OPP-2020-0047, 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/where-send-comments-epa-dockets. 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 May 8, 2020 (85 FR 27346) (FRL-10008-
38), 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
9E8800) by IR-4, Rutgers, the State University of New Jersey, 500
College Road East, Suite 201 W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.368(a)(2) be amended by establishing
tolerances for residues of the herbicide S-metolachlor, S-2-chloro-N-
(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide, its R-
enantiomer, and its metabolites, determined as the derivatives, 2-(2-
ethyl-6-methylphenyl)amino-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-
hydroxy-5-methyl-3-morpholinone, calculated as the stoichiometric
equivalent of S-metolachlor, in or on Dillweed at 5 parts per million
(ppm); Dillweed, dried leaves at 9 ppm; Dill, seed at 15 ppm; Rosemary,
dried leaves at 2 ppm and Rosemary, fresh leaves 1.5 ppm. One comment
was received on the notice of filing. EPA's response to this comment is
discussed in Unit IV.C.
In the Federal Register of March 3, 2020 (85 FR 12454) (FRL-10005-
58), 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
9F8764) by Syngenta Crop Protection, LLC., P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR 180.368(a)(2) be amended
by revising the tolerances for residues of the herbicide S-metolachlor,
S-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide, its R-enantiomer, and its metabolites,
determined as the derivatives, 2-(2-ethyl-6-methylphenyl)amino-1-
propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-
morpholinone, calculated as the stoichiometric equivalent of S-
metolachlor, in or on soybean seed to be 1.0 ppm and grain, aspirated
fractions to be 2.0 ppm. That document referenced a summary of the
petition prepared by Syngenta Crop Protection, LLC., the registrant,
which is available in the docket, https://www.regulations.gov. There
were no comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA is
establishing several tolerances at different levels than petitioned-for
tolerances and revised the commodity definitions for grain, aspirated
fractions and soybean, seed. The reasons for these changes are
explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of 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 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), and the factors
specified in 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 and to make a
determination on aggregate exposure for S-metolachlor including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with S-metolachlor
follows.
On March 11, 2019, EPA published in the Federal Register a final
rule establishing tolerances for residues of S-metolachlor in or on
several commodities based on the Agency's conclusion that aggregate
exposure to S-metolachlor is safe for the general population, including
infants and children. See (84 FR 8611) (FRL-9983-79). EPA is
incorporating the following portions of that document by reference
here, as they have not changed in the Agency's current assessment of S-
metolachlor tolerances: The toxicological profile and points of
departure, the cancer assessment and conclusion that a nonlinear
reference dose (RfD) approach is appropriate for assessing cancer risk,
the conclusions about cumulative risk, and the Agency's
[[Page 40130]]
determination regarding the children's safety factor. Additionally, EPA
is incorporating the assumptions for exposure assessment from the March
11, 2019 final rule, which have not changed except as explained in the
following paragraph.
EPA's dietary (food and drinking water) exposure assessments have
been updated to include the additional exposure from the new uses of S-
metolachlor on dill and rosemary and the revised use on soybean. EPA
conducted an unrefined chronic dietary (food and drinking water)
exposure and risk assessment that incorporates tolerance-level residue
values, 100% crop treated, and EPA's 2018 default processing factors.
The estimated drinking water concentrations (EDWCs) of S-
metolachlor and its metabolites for chronic exposures have also been
updated; the new value used for the chronic assessment to assess the
contribution to drinking water is 830 parts per billion (ppb), which is
lower than the previous value of 978 ppb.
An acute dietary endpoint (i.e., single dose endpoint) for risk
assessment was not identified in the toxicity database for the general
U.S. population or any other subpopulation for S-metolachlor;
therefore, an acute dietary exposure assessment was not conducted.
Chronic dietary risks are below the Agency's level of concern of 100%
of the chronic population adjusted dose (cPAD); they are estimated to
be 19% of the cPAD for all infants less than 1 year old, the group with
the highest exposure.
There are no proposed new residential uses for S-metolachlor,
although commercial use in residential areas may result in the
following short-term residential exposures that were used in the
Agency's aggregate risk assessment: Post-application dermal exposures
to youth (11 to less than 16 years old) from treated turf, to children
(6 to less than 11 years old) from treated gardens, and to children (1
to less than 2 years old) from treated turf and post-application
incidental oral exposure to children (1 to less than 2 years old) from
treated turf.
For aggregate risk assessment, exposures to S-metolachlor in food
and drinking water are combined with residential exposures for the
relevant exposure duration period. Because acute, intermediate-term, or
long-term residential exposures are not expected, aggregate acute and
chronic risk is equivalent to the dietary risks, which are below EPA's
level of concern. Moreover, based on the chronic exposure assessment,
which accounts for potential carcinogenicity, EPA does not expect S-
metolachlor to pose a cancer risk. Short-term aggregate risk, which
combines chronic (background) exposures with the expected short-term
post-application exposures mentioned above, yields margins of exposure
(MOEs) ranging from 110 to 1370, which are not of concern because they
exceed EPA's level of concern (MOEs less than or equal to 100).
Therefore, EPA concludes there is a reasonable certainty that no
harm will result to the general population, or to infants and children
from aggregate exposure to S-metolachlor residues. More detailed
information can be found in the document entitled, ``S-Metolachlor:
Human Health Risk Assessment for Petition for the Establishment of
Tolerances and Registration for Use in/on Rosemary and Dill (PP#9E8800)
and Amended Use in/on Soybean (PP# 9F8764),'' in docket IDs EPA-HQ-OPP-
2019-0652 and EPA-HQ-2020-0047.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies are available in the Pesticide
Analytical Manual (PAM) Vol. II for enforcement of S-metolachlor crop
and livestock tolerances. Pesticide regulation section 180.368, lists a
gas chromatography with nitrogen-phosphorus detector (GC/NPD) method
(Method I) for determining residues in/on crop commodities and a gas
chromatography with mass selective detector (GC/MSD) method (Method II)
for determining residues in livestock commodities. These methods
determine residues of metolachlor and its metabolites as either CGA-
37913 or CGA-49751 following acid hydrolysis.
The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
B. 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 Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
No maximum residue limits (MRLs) for S-metolachlor have been
established or proposed by Codex.
C. Response to Comments
There was one comment received on the notice of filing. The comment
stated that IR-4 is trying to get this chemical through during a
pandemic and without public notice. The commenter also stated that this
chemical should not be used on any food products that American's eat.
In response, EPA notes the existing legal framework provided by section
408 of the FFDCA states that tolerances may be set when persons seeking
such tolerances or exemptions have demonstrated that the pesticide
meets the safety standard imposed by that statute. This comment appears
to be directed at the underlying statute and not EPA's implementation
of it; the comment provides no information relevant the Agency's safety
determination.
D. Revisions to Petitioned-For Tolerances
The Agency is establishing the tolerances for grain, aspirated
fractions and soybean, seed at different levels than the petitioner
requested. For grain, aspirated fractions, EPA calculated the tolerance
level using the highest average field trial (HAFT) residues in
combination with the median processing factor from the submitted
soybean data. This results in a tolerance of 4 ppm rather than the
proposed tolerance of 2.0 ppm. EPA calculated the tolerance level for
soybean, seed using the HAFT residue values from the submitted soybean
data in the Organization for Economic Cooperation and Development
(OECD) MRL calculator. This results in a tolerance of 0.9 ppm rather
than the proposed tolerance of 1.0 ppm. In addition, the commodity
definitions were revised for grain, aspirated fractions and soybean,
seed. Finally, a tolerance for residues in/on soybean, meal at 1.5 ppm
has been added by the Agency based on the submitted soybean data,
because the HAFT residues in combination with the median processing
factor from the submitted data result in a value higher than the
tolerance level for soybean, seed.
[[Page 40131]]
V. Conclusion
Therefore, tolerances are established for residues of S-
metolachlor, S-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide, its R-enantiomer, and its metabolites,
determined as the derivatives, 2-(2-ethyl-6-methylphenyl)amino-1-
propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-
morpholinone, calculated as the stoichiometric equivalent of S-
metolachlor in or on dill, seed at 15 ppm; dillweed at 5 ppm; dillweed,
dried leaves at 9 ppm; rosemary, dried leaves at 2 ppm; rosemary, fresh
leaves at 1.5 ppm; and soybean, meal at 1.5 ppm. In addition, the
Agency is increasing the tolerances for residues of S-metolachlor in or
on grain, aspirated fractions to be 4 ppm and soybean, seed to be 0.9
ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to petitions 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 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 19, 2020.
Michael Goodis,
Director, Registration Division, 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. In Sec. 180.368, paragraph (a)(2):
0
i. Add a heading to the table.
0
ii. Add alphabetically the entries ``Dill, seed''; ``Dillweed'' and
``Dillweed, dried leaves''.
0
iii. Revise the entry for ``Grain, aspirated fractions''.
0
iv. Add alphabetically the entries ``Rosemary, dried leaves'';
``Rosemary, fresh leaves'' and ``Soybean, meal''.
0
v. Revise the entry for ``Soybean, seed''.
The additions and revisions read as follows:
Sec. 180.368 Metolachlor, tolerances for residues.
(a) * * *
(2) * * *
Table 2 to Paragraph (a)(2)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Dill, seed................................................. 15
Dillweed................................................... 5
Dillweed, dried leaves..................................... 9
* * * * *
Grain, aspirated fractions................................. 4
* * * * *
Rosemary, dried leaves..................................... 2
Rosemary, fresh leaves..................................... 1.5
* * * * *
Soybean, meal.............................................. 1.5
Soybean, seed.............................................. 0.9
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2020-14393 Filed 7-2-20; 8:45 am]
BILLING CODE 6560-50-P
