Trifloxystrobin; Pesticide Tolerance, 13059-13062 [2020-04208]
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Federal Register / Vol. 85, No. 45 / Friday, March 6, 2020 / Rules and Regulations
Nitrogen dioxide, Ozone, Volatile
organic compounds.
2. In § 52.1170, the table in paragraph
(e) is amended by revising the three
entries for ‘‘1997 8-hour ozone’’ under
‘‘Maintenance Plans’’ to read as follows:
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PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
Dated: February 21, 2020.
Kurt A. Thiede,
Regional Administrator, Region 5.
1. The authority citation for part 52
continues to read as follows:
■
Amend 40 CFR part 52 as follows:
§ 52.1170
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Authority: 42 U.S.C. 7401 et seq.
Identification of plan.
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(e) * * *
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EPA-APPROVED MICHIGAN NONREGULATORY AND QUASI-REGULATORY PROVISIONS
Name of nonregulatory
SIP provision
Applicable geographic or nonattainment area
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State submittal date
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EPA approval date
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Comments
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Maintenance Plans
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1997 8-hour ozone .....
1997 8-hour ozone .....
1997 8-hour ozone .....
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Benzie County, Flint, Grand Rapids, Huron 7/24/2019 ...................
County, Kalamazoo-Battle Creek, LansingEast Lansing, and Mason County.
Benton Harbor, Cass County, and Muskegon 6/13/2006, 8/25/2006,
and 11/30/2006.
Detroit-Ann Arbor ........................................... 3/6/2009 .....................
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[FR Doc. 2020–04356 Filed 3–5–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2019–0130; FRL–10004–08]
Trifloxystrobin; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
This regulation establishes a
tolerance for residues of trifloxystrobin
in or on pea and bean, dried shelled,
except soybean, subgroup 6C. Bayer
CropScience requested this tolerance
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective
March 6, 2020. Objections and requests
for hearings must be received on or
before May 5, 2020, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2019–0130, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
SUMMARY:
*
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:
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).
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3/6/2020, [insert Federal Register citation].
5/16/2007, 72 FR
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6/29/2009, 74 FR
30950.
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2nd limited maintenance plan.
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• 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/cgibin/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–2019–0130 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 May
5, 2020. Addresses for mail and hand
delivery of objections and hearing
requests are provided in 40 CFR
178.25(b).
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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–
2019–0130, 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 June 7, 2019
(84 FR 26630) (FRL–9993–93), 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 8F8729) by Bayer
CropScience, 2 T.W. Alexander Drive,
P.O. Box 12014, Research Triangle Park,
NC 27709. The petition requested that
40 CFR part 180 be amended by
establishing tolerances for residues of
the fungicide, trifloxystrobin
(benzeneacetic acid, (E,E)-alpha(methoxyimino)-2-[[[[1-[3(trifluoromethyl)
phenyl]ethylidene]amino]oxy]methyl]methyl ester) and the free form of its
acid metabolite CGA–321113 ((E,E)methoxyimino-[2-[1-(3trifluoromethylphenyl)ethylideneaminooxymethyl]phenyl]acetic acid) in or on dried
shelled pea and bean (except soybean)
subgroup 6C at 0.06 parts per million
(ppm). That document referenced a
summary of the petition prepared by
Bayer CropScience, the registrant,
which is available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
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Based upon review of the data
supporting the petition, EPA has
modified the crop group name to be
consistent with Agency nomenclature.
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 trifloxystrobin
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with trifloxystrobin follows.
On February 15, 2019 (84 FR 4340)
(FRL–9985–23), EPA published in the
Federal Register a final rule establishing
a tolerance for residues of the fungicide
trifloxystrobin in or on flax seed and
amending an existing tolerance for
aspirated grain fractions based on the
Agency’s conclusion that aggregate
exposure to trifloxystrobin is safe for the
general population, including infants
and children. See 84 FR 4340 (FRL–
9985–23). That document contains a
summary of the toxicological profile and
points of departure, assumptions for
exposure assessment, and Agency’s
determination regarding the children’s
safety factor, which have not changed.
The Agency conducted a revised risk
assessment to incorporate additional
exposure to residues of trifloxystrobin
approved since that rulemaking and
including the use on pea and bean,
dried shelled, except soybean, subgroup
6C.
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EPA’s exposure assessments have
been updated to include the additional
exposure from use of trifloxystrobin
from use on pea and bean, dried shelled,
except soybean, subgroup 6C, i.e.,
reliance on tolerance-level residues and
an assumption of 100 percent crop
treated (PCT). EPA’s aggregate exposure
assessment incorporated this additional
dietary exposure, as well as exposure in
drinking water and from residential
sources, although those latter exposures
are not impacted by the new uses on pea
and bean and thus have not changed
since the last assessment. Further
information about EPA’s risk assessment
and determination of safety supporting
the tolerances established in the
February 15, 2019 Federal Register
action, as well as the new trifloxystrobin
tolerance can be found at https://
www.regulations.gov in the document
entitled ‘‘Trifloxystrobin. Human Health
Risk Assessment for the Proposed New
Use on Flax Seed and Increase of
Established Tolerance on Aspirated
Grain Fractions,’’ dated October 31,
2018, in docket ID EPA–HQ–OPP–2017–
0532.
Acute dietary risks are below the
Agency’s level of concern: 3.4% of the
acute population adjusted dose (aPAD)
for females 13 to 49 years old, the only
population group of concern. Chronic
dietary risks are below the Agency’s
level of concern: 58% of the chronic
population adjusted dose (cPAD) for all
infants less than 1 year old, the group
with the highest exposure. There is not
expected to be any handler exposure,
and there is no adverse systemic hazard
via the dermal route of exposure, so the
only residential post-application
scenario assessed was for the incidental
short-term oral exposure of children 1 to
less than 2 years old. Using the
exposure assumptions described for
short-term exposures, EPA has
concluded the combined short-term
food, water, and residential exposures
result in aggregate MOEs above the LOC
of 100 for all scenarios assessed and are
not of concern.
Therefore, based on the risk
assessments and information described
above, 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 trifloxystrobin residues.
More detailed information on the
subject action to establish a tolerance in
or on pea and bean, dried shelled,
except soybean, subgroup 6C can be
found in the document entitled,
‘‘Trifloxystrobin. Human Health
Aggregate Risk Assessment for New Use
on Dry Beans and Proposed Crop Group
Expansion from Dry Pea to Crop
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Subgroup 6C’’ by going to https://
www.regulations.gov. The referenced
document is available in the docket
established by this action, which is
described under ADDRESSES. Locate and
click on the hyperlink for docket ID
number EPA–HQ–OPP–2019–0130.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(gas chromatography method with
nitrogen phosphorus detection (GC/
NPD)) is available to enforce the
tolerance expression. The method 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.
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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.
Codex has established an MRL of 0.01
ppm for several of the commodities in
subgroup 6C with the exception of
broad bean, chickpea, cowpea, guar,
lupin, blackeyed pea, crowder pea,
pigeon pea and southern pea for which
no MRL is established. U.S. tolerances
for residues in the commodities of
subgroup 6C are not harmonized with
Codex. Since the Codex MRL is
significantly lower for some
commodities, harmonization is not
possible because lowering the U.S.
tolerance could cause U.S. growers to
have violative residues despite legal use
of the pesticide.
V. Conclusion
Therefore, tolerances are established
for residues of trifloxystrobin in or on
pea and bean, dried shelled, except
soybean, subgroup 6C at 0.06 ppm.
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Additionally, the existing tolerance on
‘‘pea, dry, seed’’ is removed as
unnecessary since it is part of the new
subgroup 6C tolerance.
VI. Statutory and Executive Order
Reviews
This action establishes a tolerance
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997), nor is it considered a
regulatory action under Executive Order
13771, entitled ‘‘Reducing Regulations
and Controlling Regulatory Costs’’ (82
FR 9339, February 3, 2017). This action
does not contain any information
collections subject to OMB approval
under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does
it require any special considerations
under Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or Tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or Tribal Governments, on the
relationship between the National
Government and the States or Tribal
Governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
Tribes. Thus, the Agency has
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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: February 6, 2020.
Michael Goodis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.555, amend the table in
paragraph (a) as follows:
■
a. Add alphabetically the entry for
‘‘Pea and bean, dried shelled, except
soybean, subgroup 6C’’; and
■
b. Remove the entry for ‘‘Pea, dry,
seed’’.
■
The addition reads as follows:
§ 180.555 Trifloxystrobin; tolerances for
residues.
(a) * * *
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Parts per
million
Commodity
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Pea and bean, dried shelled, except soybean, subgroup 6C ....
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0.06
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[FR Doc. 2020–04208 Filed 3–5–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 710
SUPPLEMENTARY INFORMATION:
[EPA–HQ–OPPT–2018–0320; FRL–10005–
48]
I. Executive Summary
RIN 2070–AK21
A. What action is the Agency taking?
Procedures for Review of CBI Claims
for the Identity of Chemicals on the
TSCA Inventory
This final rule establishes the CBI
substantiation requirements for
manufacturers (which under TSCA
includes importers) and processors who
claimed specific chemical identities as
CBI in previously filed Notices of
Activity (NOAs) Form A (Ref. 1) in
accordance with the 2017 TSCA
Inventory Notification (Active-Inactive)
Requirements rule (hereinafter ‘‘2017
Active-Inactive Rule,’’ which is
summarized in more detail in Unit III
and codified in 40 CFR part 710, subpart
B) (Ref. 2). This final rule also amends
the existing CBI substantiation
requirements for manufacturers and
processors who have filed or will file
NOAs Form B (Ref. 3) and claimed or
claim specific chemical identities as
CBI. Manufacturers and processors who
previously provided substantiations in
NOAs Form A or B for CBI claims for
specific chemical identities pursuant to
the 2017 Active-Inactive Rule will be
required to supplement those
substantiations to include responses to
two new questions related to a specific
chemical identity’s susceptibility to
reverse engineering. All substantiations
must be submitted to the Agency using
EPA’s Central Data Exchange (CDX), the
Agency’s electronic reporting portal.
This final rule describes the Agency’s
plan to review the CBI claims for
specific chemical identities that were
asserted in NOAs Form A during the
one-time retrospective reporting period
under the 2017 Active-Inactive Rule,
including procedures for the Agency’s
publication of annual review goals and
results. EPA will review each specific
chemical identity CBI claim and
substantiation, and approve or deny
each claim consistent with the
procedures and substantive criteria in
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
EPA is finalizing
requirements for regulated entities to
substantiate certain confidential
business information (CBI) claims made
under the Toxic Substances Control Act
(TSCA) to protect the specific chemical
identities of chemical substances on the
confidential portion of the TSCA
Inventory, and the Agency’s plan for
reviewing certain CBI claims for specific
chemical identities. The substantiation
requirements describe the applicable
procedures and provide instructions for
regulated entities. The Agency’s plan
sets out the review criteria and related
procedures that EPA will use to
complete the reviews within the fiveyear timeframe set in TSCA.
DATES: This final rule is effective on
May 5, 2020.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPPT–2018–0320, is
available at https://www.regulations.gov
or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket),
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC.
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 OPPT
Docket is (202) 566–0280. Please review
SUMMARY:
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the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact:
Scott M. Sherlock, Environmental
Assistance Division (Mail code 7408M),
Office of Pollution Prevention and
Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
number: (202) 564–8257; email address:
sherlock.scott@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
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TSCA sections 8(b)(4) and 14 and 40
CFR part 2, subpart B.
EPA is amending the existing
regulations in 40 CFR part 710, subpart
B, and is adding provisions about the
NOA Form A substantiation process and
the Agency’s review plan to a new
subpart C.
B. What is the Agency’s authority for
taking this action?
EPA is issuing this rule pursuant to
the authority in TSCA section 8(b), 15
U.S.C. 2607(b).
C. Why is the Agency taking this action?
TSCA section 8(b)(4)(C) requires EPA
to promulgate a rule that establishes the
Agency’s plan to review all CBI claims
for the specific chemical identities of
chemical substances on the confidential
portion of the TSCA Inventory that were
asserted in an NOA Form A pursuant to
the one-time retrospective reporting
under the 2017 Active-Inactive Rule.
The 2017 Active-Inactive Rule required
any reporter who sought to maintain an
existing CBI claim for a specific
chemical identity to assert that claim as
part of the submission of an NOA Form
A, but the rule did not require
substantiation of those claims at that
time. This final rule implements the
statutory substantiation and review
requirements so as to ensure that only
those specific chemical identities that
currently qualify for confidential
treatment are protected from disclosure
by the Agency.
This final rule also addresses a
Federal court remand of the 2017
Active-Inactive Rule by amending that
rule to add two substantiation questions
which will be applicable to all NOA
Form B reporters who seek to maintain
an existing CBI claim for a specific
chemical identity, and by including the
same two questions in the newly
finalized substantiation requirements
for NOA Form A reporters who seek to
maintain an existing CBI claim for a
specific chemical identity. These
substantiation questions address
whether a specific chemical identity is
readily discoverable through reverse
engineering and will ensure the
submission of information that EPA will
use to evaluate CBI claims for specific
chemical identities.
D. Who does this action apply to?
You may be affected by this action if
you reported a confidential chemical
substance under the 2017 ActiveInactive Rule using an NOA Form A or
NOA Form B and sought to maintain an
existing CBI claim for a specific
chemical identity. You may also be
affected by this action if you anticipate
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]]>Agencies
[Federal Register Volume 85, Number 45 (Friday, March 6, 2020)]
[Rules and Regulations]
[Pages 13059-13062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04208]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0130; FRL-10004-08]
Trifloxystrobin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
trifloxystrobin in or on pea and bean, dried shelled, except soybean,
subgroup 6C. Bayer CropScience requested this tolerance under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective March 6, 2020. Objections and
requests for hearings must be received on or before May 5, 2020, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0130, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: 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 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 number EPA-HQ-OPP-2019-0130 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
May 5, 2020. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
[[Page 13060]]
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-2019-0130, 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 June 7, 2019 (84 FR 26630) (FRL-9993-
93), 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
8F8729) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014,
Research Triangle Park, NC 27709. The petition requested that 40 CFR
part 180 be amended by establishing tolerances for residues of the
fungicide, trifloxystrobin (benzeneacetic acid, (E,E)-alpha-
(methoxyimino)-2-[[[[1-[3-(trifluoromethyl)
phenyl]ethylidene]amino]oxy]methyl]-methyl ester) and the free form of
its acid metabolite CGA-321113 ((E,E)-methoxyimino-[2-[1-(3-
trifluoromethylphenyl)-ethylideneaminooxymethyl]-phenyl]acetic acid) in
or on dried shelled pea and bean (except soybean) subgroup 6C at 0.06
parts per million (ppm). That document referenced a summary of the
petition prepared by Bayer CropScience, 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 has
modified the crop group name to be consistent with Agency nomenclature.
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 trifloxystrobin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with trifloxystrobin
follows.
On February 15, 2019 (84 FR 4340) (FRL-9985-23), EPA published in
the Federal Register a final rule establishing a tolerance for residues
of the fungicide trifloxystrobin in or on flax seed and amending an
existing tolerance for aspirated grain fractions based on the Agency's
conclusion that aggregate exposure to trifloxystrobin is safe for the
general population, including infants and children. See 84 FR 4340
(FRL-9985-23). That document contains a summary of the toxicological
profile and points of departure, assumptions for exposure assessment,
and Agency's determination regarding the children's safety factor,
which have not changed. The Agency conducted a revised risk assessment
to incorporate additional exposure to residues of trifloxystrobin
approved since that rulemaking and including the use on pea and bean,
dried shelled, except soybean, subgroup 6C.
EPA's exposure assessments have been updated to include the
additional exposure from use of trifloxystrobin from use on pea and
bean, dried shelled, except soybean, subgroup 6C, i.e., reliance on
tolerance-level residues and an assumption of 100 percent crop treated
(PCT). EPA's aggregate exposure assessment incorporated this additional
dietary exposure, as well as exposure in drinking water and from
residential sources, although those latter exposures are not impacted
by the new uses on pea and bean and thus have not changed since the
last assessment. Further information about EPA's risk assessment and
determination of safety supporting the tolerances established in the
February 15, 2019 Federal Register action, as well as the new
trifloxystrobin tolerance can be found at https://www.regulations.gov in
the document entitled ``Trifloxystrobin. Human Health Risk Assessment
for the Proposed New Use on Flax Seed and Increase of Established
Tolerance on Aspirated Grain Fractions,'' dated October 31, 2018, in
docket ID EPA-HQ-OPP-2017-0532.
Acute dietary risks are below the Agency's level of concern: 3.4%
of the acute population adjusted dose (aPAD) for females 13 to 49 years
old, the only population group of concern. Chronic dietary risks are
below the Agency's level of concern: 58% of the chronic population
adjusted dose (cPAD) for all infants less than 1 year old, the group
with the highest exposure. There is not expected to be any handler
exposure, and there is no adverse systemic hazard via the dermal route
of exposure, so the only residential post-application scenario assessed
was for the incidental short-term oral exposure of children 1 to less
than 2 years old. Using the exposure assumptions described for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs above the LOC of 100
for all scenarios assessed and are not of concern.
Therefore, based on the risk assessments and information described
above, 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 trifloxystrobin residues. More detailed
information on the subject action to establish a tolerance in or on pea
and bean, dried shelled, except soybean, subgroup 6C can be found in
the document entitled, ``Trifloxystrobin. Human Health Aggregate Risk
Assessment for New Use on Dry Beans and Proposed Crop Group Expansion
from Dry Pea to Crop
[[Page 13061]]
Subgroup 6C'' by going to https://www.regulations.gov. The referenced
document is available in the docket established by this action, which
is described under ADDRESSES. Locate and click on the hyperlink for
docket ID number EPA-HQ-OPP-2019-0130.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography method with
nitrogen phosphorus detection (GC/NPD)) is available to enforce the
tolerance expression. The method 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.
Codex has established an MRL of 0.01 ppm for several of the
commodities in subgroup 6C with the exception of broad bean, chickpea,
cowpea, guar, lupin, blackeyed pea, crowder pea, pigeon pea and
southern pea for which no MRL is established. U.S. tolerances for
residues in the commodities of subgroup 6C are not harmonized with
Codex. Since the Codex MRL is significantly lower for some commodities,
harmonization is not possible because lowering the U.S. tolerance could
cause U.S. growers to have violative residues despite legal use of the
pesticide.
V. Conclusion
Therefore, tolerances are established for residues of
trifloxystrobin in or on pea and bean, dried shelled, except soybean,
subgroup 6C at 0.06 ppm. Additionally, the existing tolerance on ``pea,
dry, seed'' is removed as unnecessary since it is part of the new
subgroup 6C tolerance.
VI. Statutory and Executive Order Reviews
This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
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: February 6, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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2. In Sec. 180.555, amend the table in paragraph (a) as follows:
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a. Add alphabetically the entry for ``Pea and bean, dried shelled,
except soybean, subgroup 6C''; and
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b. Remove the entry for ``Pea, dry, seed''.
The addition reads as follows:
Sec. 180.555 Trifloxystrobin; tolerances for residues.
(a) * * *
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Parts per
Commodity million
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Pea and bean, dried shelled, except soybean, subgroup 6C.... 0.06
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[FR Doc. 2020-04208 Filed 3-5-20; 8:45 am]
BILLING CODE 6560-50-P
