Trifloxystrobin; Pesticide Tolerances, 29384-29386 [2019-13101]
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29384
Federal Register / Vol. 84, No. 121 / Monday, June 24, 2019 / Rules and Regulations
MASSACHUSETTS NON REGULATORY—Continued
Name of
non regulatory
SIP provision
Infrastructure SIP
submittal for
2010 NO2
NAAQS.
Infrastructure SIP
submittal for
2010 SO2
NAAQS.
*
Applicable
geographic or
nonattainment area
State submittal
date/effective
date
EPA approved
date 3
Explanations
Statewide .................
February 9, 2018 .....
Converts conditional approval for CAA section
110(a)(2)(A), which was conditionally approved December 21, 2016, to full approval.
Statewide .................
February 9, 2018 .....
June 24, 2019 [Insert Federal
Register citation].
June 24, 2019 [Insert Federal
Register citation].
*
*
*
Converts conditional approval for CAA section
110(a)(2)(A), which was conditionally approved December 21, 2016, to full approval.
*
*
*
3 To
determine the EPA effective date for a specific provision listed in this table, consult the Federal Register notice cited in this column for
the particular provision.
4. Section 52.1131 is amended by
revising the entries for paragraphs (c)
and (f) and adding paragraph (h) to read
as follows:
■
§ 52.1131
matter.
Control strategy: Particulate
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(c) Conditional Approval (satisfied)—
Submittal from the Massachusetts
Department of Environmental
Protection, dated April 4, 2008, to
address the Clean Air Act (CAA)
infrastructure requirements for the 1997
PM2.5 NAAQS is conditionally approved
for CAA elements 110(a)(2)(A) and
(E)(ii). This conditional approval is
contingent upon Massachusetts taking
actions to meet requirements of these
elements within one year of conditional
approval, as committed to in a letter
from the state to EPA Region 1 dated
July 12, 2012. The Massachusetts
Department of Environmental Protection
made a submittal to satisfy these
conditions on February 9, 2018. EPA
approved the submittal and converted
the conditional approval to a full
approval on June 24, 2019.
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*
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*
(f) Conditional Approval (satisfied)—
Submittal from the Massachusetts
Department of Environmental
Protection, dated September 21, 2009,
with supplements submitted on January
13, 2011, and August 19, 2011, to
address the Clean Air Act (CAA)
infrastructure requirements for the 2006
PM2.5 NAAQS is conditionally approved
for CAA elements 110(a)(2)(A) and
(E)(ii). This conditional approval is
contingent upon Massachusetts taking
actions to meet requirements of these
elements within one year of conditional
approval, as committed to in a letter
from the state to EPA Region 1 dated
July 12, 2012. The Massachusetts
Department of Environmental Protection
made a submittal to satisfy these
conditions on February 9, 2018. EPA
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approved the submittal and converted
the conditional approval to a full
approval on June 24, 2019.
*
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(h) Approval—Submittal from the
Massachusetts Department of
Environmental Protection, dated
February 9, 2018, to address the Clean
Air Act (CAA) infrastructure
requirements for the 2012 PM2.5
NAAQS. This submittal satisfies
requirements of CAA sections
110(a)(2)(A), (B), (C), (D), (E), (F), (G),
(H), (J), (K), (L), and (M), with the
exception of PSD-related requirements
of (C), (D), and (J). Approval includes
interstate transport requirements. EPA
approved the submittal on June 24,
2019.
[FR Doc. 2019–13325 Filed 6–21–19; 8:45 am]
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2018–0206, 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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2018–0206; FRL–9994–67]
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:
Trifloxystrobin; Pesticide Tolerances
I. General Information
AGENCY:
Environmental Protection
Agency (EPA).
ACTION: Final rule.
A. Does this action apply to me?
This regulation establishes
tolerances for residues of trifloxystrobin
in or on tea (dried and instant). Bayer
CropScience requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective June
24, 2019. Objections and requests for
hearings must be received on or before
August 23, 2019 and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
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).
SUMMARY:
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Federal Register / Vol. 84, No. 121 / Monday, June 24, 2019 / Rules and Regulations
• Pesticide manufacturing (NAICS
code 32532).
II. Summary of Petitioned-For
Tolerance
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.
In the Federal Register of March 18,
2019 (84 FR 9735) (FRL–9989–90), 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 8E8671) by Bayer
CropScience LP2, T.W. Alexander Dr.,
Research Triangle Park, NC 27709. The
petition requested that 40 CFR part 180
be amended by establishing a tolerance
for residues of the fungicide
trifloxystrobin in or on tea, dried at 5
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
determined that a tolerance is also
needed for the commodity ‘‘tea, instant’’
at 5 ppm. The need for this tolerance is
explained in Unit IV.C.
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–2018–0206 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing and must be received
by the Hearing Clerk on or before
August 23, 2019. Addresses for mail and
hand delivery of objections and hearing
requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2018–0206, 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.
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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 in
or on tea.
In the Federal Register on February
15, 2019 (84 FR 4340) (FRL–9985–23),
EPA published a final rule establishing
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a tolerance for residues of
trifloxystrobin in or on flax seed and
amended 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. Because the toxicity
profile of trifloxystrobin has not
changed since that rule was published,
EPA is incorporating the discussion of
that profile and the identified
toxicological endpoints, including the
determination to reduce the children’s
safety factor, as part of this rulemaking.
EPA’s exposure assessments have
been updated to include the additional
exposure from use of trifloxystrobin on
tea, i.e., reliance on tolerance-level
residues and an assumption of 100
percent crop treated (PCT). Because the
use on tea is not an approved domestic
use, there is no expectation of an
increased exposure in drinking water or
for non-dietary, non-occupational
sources, although the additional dietary
exposure contributes to overall
aggregate exposure. 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 documents entitled:
‘‘Trifloxystrobin. Human Health Risk
Assessment for the Proposed New Use
on Flax Seed and Increase of
Established Tolerance on Aspirated
Grain Fractions’’ and ‘‘Trifloxystrobin.
Dietary (Food and Drinking Water) and
Risk Assessment for Harmonization on
Imported Tea.’’ The documents may be
found in docket ID number EPA–HQ–
OPP–2018–0206.
As indicated in the supporting
documents, the acute and chronic
dietary risks are below the Agency’s
level of concern: 3.4% of the acute
population adjusted dose (aPAD) for
females 13–49 years old, the group with
the highest exposure level; 58% of the
chronic population adjusted dose
(cPAD) for all infants (less than 1 year
old), the group with the highest
exposure level. Moreover, the short-term
aggregate risk for the population with
the highest total exposure (children, 1 to
less than 2 years old) is represented by
an aggregate margin of exposure (MOE)
of 120, which is not a risk of concern
because EPA considers MOEs less than
100 to be of concern.
Therefore, based on the risk
assessments and information described
above, EPA concludes that there is a
reasonable certainty that no harm will
result to the general population, or to
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Federal Register / Vol. 84, No. 121 / Monday, June 24, 2019 / Rules and Regulations
infants and children from aggregate
exposure to trifloxystrobin residues.
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.
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.
The Codex has not established a MRL
for trifloxystrobin in or on tea.
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C. Revisions to Petitioned-For Tolerance
Based on the review of the data, the
Agency has determined that a tolerance
is also needed for the commodity ‘‘tea,
instant.’’ The raw agricultural
commodity (RAC) is tea, plucked leaves,
but the Agency does not set a tolerance
on the RAC. ‘‘Tea, dried’’ and ‘‘tea,
instant’’ are the processed commodities
for this RAC tolerance and therefore,
EPA has to set tolerances on both of
these processed commodities.
V. Conclusion
Therefore, tolerances are established
for residues of trifloxystrobin, including
its metabolites and degradates, in or on
tea, dried at 5 ppm and tea, instant at
5 ppm.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
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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
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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: May 29, 2019.
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, add alphabetically the
entries ‘‘Tea, dried’’ and ‘‘Tea, instant’’
and footnote 3 to the table in paragraph
(a) to read as follows:
■
§ 180.555 Trifloxystrobin; tolerances for
residues.
(a) * * *
Parts per
million
Commodity
*
*
*
*
Tea, dried 3 .................................
Tea, instant 3 ...............................
*
*
*
*
*
*
5
5
*
*
*
*
*
are no U.S. registrations as of June
24, 2019, for use on tea.
3 There
*
*
*
*
*
[FR Doc. 2019–13101 Filed 6–21–19; 8:45 am]
BILLING CODE 6560–50–P
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Agencies
[Federal Register Volume 84, Number 121 (Monday, June 24, 2019)]
[Rules and Regulations]
[Pages 29384-29386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13101]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2018-0206; FRL-9994-67]
Trifloxystrobin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
trifloxystrobin in or on tea (dried and instant). Bayer CropScience
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective June 24, 2019. Objections and
requests for hearings must be received on or before August 23, 2019 and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2018-0206, 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).
[[Page 29385]]
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-2018-0206 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
August 23, 2019. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2018-0206, 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 March 18, 2019 (84 FR 9735) (FRL-9989-
90), 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
8E8671) by Bayer CropScience LP2, T.W. Alexander Dr., Research Triangle
Park, NC 27709. The petition requested that 40 CFR part 180 be amended
by establishing a tolerance for residues of the fungicide
trifloxystrobin in or on tea, dried at 5 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
determined that a tolerance is also needed for the commodity ``tea,
instant'' at 5 ppm. The need for this tolerance is explained in Unit
IV.C.
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 in or on tea.
In the Federal Register on February 15, 2019 (84 FR 4340) (FRL-
9985-23), EPA published a final rule establishing a tolerance for
residues of trifloxystrobin in or on flax seed and amended 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. Because the
toxicity profile of trifloxystrobin has not changed since that rule was
published, EPA is incorporating the discussion of that profile and the
identified toxicological endpoints, including the determination to
reduce the children's safety factor, as part of this rulemaking.
EPA's exposure assessments have been updated to include the
additional exposure from use of trifloxystrobin on tea, i.e., reliance
on tolerance-level residues and an assumption of 100 percent crop
treated (PCT). Because the use on tea is not an approved domestic use,
there is no expectation of an increased exposure in drinking water or
for non-dietary, non-occupational sources, although the additional
dietary exposure contributes to overall aggregate exposure. 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 documents entitled:
``Trifloxystrobin. Human Health Risk Assessment for the Proposed New
Use on Flax Seed and Increase of Established Tolerance on Aspirated
Grain Fractions'' and ``Trifloxystrobin. Dietary (Food and Drinking
Water) and Risk Assessment for Harmonization on Imported Tea.'' The
documents may be found in docket ID number EPA-HQ-OPP-2018-0206.
As indicated in the supporting documents, the acute and chronic
dietary risks are below the Agency's level of concern: 3.4% of the
acute population adjusted dose (aPAD) for females 13-49 years old, the
group with the highest exposure level; 58% of the chronic population
adjusted dose (cPAD) for all infants (less than 1 year old), the group
with the highest exposure level. Moreover, the short-term aggregate
risk for the population with the highest total exposure (children, 1 to
less than 2 years old) is represented by an aggregate margin of
exposure (MOE) of 120, which is not a risk of concern because EPA
considers MOEs less than 100 to be of concern.
Therefore, based on the risk assessments and information described
above, EPA concludes that there is a reasonable certainty that no harm
will result to the general population, or to
[[Page 29386]]
infants and children from aggregate exposure to trifloxystrobin
residues.
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.
The Codex has not established a MRL for trifloxystrobin in or on
tea.
C. Revisions to Petitioned-For Tolerance
Based on the review of the data, the Agency has determined that a
tolerance is also needed for the commodity ``tea, instant.'' The raw
agricultural commodity (RAC) is tea, plucked leaves, but the Agency
does not set a tolerance on the RAC. ``Tea, dried'' and ``tea,
instant'' are the processed commodities for this RAC tolerance and
therefore, EPA has to set tolerances on both of these processed
commodities.
V. Conclusion
Therefore, tolerances are established for residues of
trifloxystrobin, including its metabolites and degradates, in or on
tea, dried at 5 ppm and tea, instant at 5 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller 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 29, 2019.
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. 180.555, add alphabetically the entries ``Tea, dried'' and
``Tea, instant'' and footnote 3 to the table in paragraph (a) to read
as follows:
Sec. 180.555 Trifloxystrobin; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Tea, dried \3\.............................................. 5
Tea, instant \3\............................................ 5
* * * * *
------------------------------------------------------------------------
* * * * *
\3\ There are no U.S. registrations as of June 24, 2019, for use on tea.
* * * * *
[FR Doc. 2019-13101 Filed 6-21-19; 8:45 am]
BILLING CODE 6560-50-P