[Federal Register Volume 86, Number 154 (Friday, August 13, 2021)]
[Rules and Regulations]
[Pages 44623-44626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16973]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0050; FRL-8560-01-OCSPP]
Boscalid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
boscalid in or on tea, dried; tea, instant. BASF Corporation requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective August 13, 2021. Objections and
requests for hearings must be received
[[Page 44624]]
on or before October 12, 2021, and must be filed in accordance with the
instructions provided in 40 CFR part 178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0050, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
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 http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2020-0050 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
October 12, 2021. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2020-0050, by one of
the following methods:
Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of September 30, 2020 (85 FR 61681) (FRL-
10014-74), 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
9E8819) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, NC 27709. The petition requested that 40 CFR 180.589 be
amended by establishing tolerances for residues of the fungicide
boscalid in or on tea at 80 parts per million (ppm). That document
referenced a summary of the petition prepared by BASF Corporation, the
registrant, which is available in the docket, http://www.regulations.gov. No comments were received in response to the
notice of filing.
FFDCA section 408(d)(4)(A)(i) permits the Agency to finalize a
tolerance that varies from that sought by the petition. Based upon
review of the data supporting the petition, EPA has modified the
tolerance level being established and corrected the commodity
definition of ``tea'' to ``tea, dried'' and ``tea, instant.'' The
reason for these changes is explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
A. Statutory Background
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 therein, 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 boscalid including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with boscalid follows.
B. Aggregate Risk Assessment
In an effort to streamline Federal Register publications, EPA is
not
[[Page 44625]]
reprinting sections that have not changed from previous rulemakings for
the same pesticide. On October 19, 2018, EPA published in the Federal
Register a final rule establishing tolerances for residues of boscalid
in or on multiple commodities based on the Agency's conclusion that
aggregate exposure to boscalid is safe for the general population,
including infants and children. See 83 FR 52991 (EPA-HQ-OPP-2017-0310).
Refer to the following sections from the previous tolerance rulemaking
for boscalid that have remained the same under the current risk
assessment: Units III.A (Toxicological Profile); III.B (Toxicological
Points of Departure/Levels of Concern); III.C. (Exposure Assessment),
except as explained below; and III.D. (Safety Factor for Infants and
Children). EPA has conducted an updated human health risk assessment to
evaluate the safety of the requested tolerances, which is limited to an
updated dietary exposure and risk assessment, and subsequent updates to
the aggregate exposure and risk assessment. See ``Boscalid. Human
Health Risk Assessment for the Establishment of a Permanent Tolerance
Without a U.S. Registration on Tea.'' (D456100, 04/01/2021), which is
available in the docket established by this action, EPA-HQ-OPP-2020-
0050.
Updates to exposure assessment. EPA's dietary (food and drinking
water) exposure assessments have been updated to include the potential
additional exposure from the tolerance for boscalid residues in or on
tea, dried and tea, instant. The exposure assessments relied on
tolerance-level residues for all crops and an assumption of 100 percent
crop treated (PCT) as the October 19, 2018, final rule. Exposure in
drinking water and from residential sources are not impacted by the
increased tolerance on tea, dried and tea, instant because the
tolerances are without U.S. registration.
Assessment of aggregate risks. An acute dietary exposure assessment
was not conducted because there were no observed effects attributable
to a single dose. Chronic dietary risks are below the Agency's level of
concern of 100% of the chronic population adjusted dose (cPAD): 60% of
the cPAD for children 1 to 2 years old, the most highly exposed
population subgroup.
For the aggregate risk assessment, exposures to boscalid in food
and drinking water are combined with residential exposures for the
relevant exposure duration period. There is potential for short-term
aggregate exposure to boscalid via dietary (which is considered
background exposure) and residential (which is considered primary)
exposure pathways. The short-term aggregate margins of exposure (MOEs)
are 160 for children 6 to 11 years old, 360 for youth 11 to 16 years
old, and 130 for adults (LOC = 100), which are not of concern because
they exceed EPA's level of concern (MOEs less than or equal to 100).
A separate cancer dietary assessment was not conducted since
boscalid was classified by the Cancer Assessment Review Committee
(CARC) as ``suggestive evidence of carcinogenicity''; and the chronic
exposure assessment is protective of any cancer risks. Therefore, based
on the chronic exposure assessment, which accounts for potential
carcinogenicity, EPA does not expect boscalid to pose a cancer risk.
C. Determination of Safety
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 boscalid residues. More detailed information
about the Agency's analysis can be found in the document entitled,
``Boscalid. Human Health Risk Assessment for the Establishment of a
Permanent Tolerance Without a U.S. Registration on Tea.'' (D456100, 04/
01/2021) by going to http://www.regulations.gov.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate methods exist for both plants and livestock. In plants,
the parent residue is extracted using an aqueous organic solvent
mixture followed by liquid/liquid partitioning and a column clean up.
Quantitation is by gas chromatography using mass spectrometry (GC/MS)
or liquid chromatography in tandem with mass spectrometric detection
(LC/MS/MS). In livestock, the residues are extracted with methanol. The
extract is treated with enzymes in order to release the conjugated
glucuronic acid metabolite. The residues are then isolated by liquid/
liquid partition followed by column chromatography. The hydroxylated
metabolite is acetylated followed by a column clean-up. The parent and
acetylated metabolite are quantitated by gas chromatography with
electron capture detection.
Adequate enforcement methodology, extraction using an aqueous
organic solvent mixture followed by liquid/liquid partitioning and a
column clean up with quantitation by gas chromatography using mass
spectrometry (GC/MS) or liquid chromatography in tandem with mass
spectrometric detection (LC/MS/MS), 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). 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 boscalid. Taiwan has an MRL for residues of
boscalid in/on dried tea leaves at 10 ppm, and Japan has an MRL of
residues of boscalid in/on dried tea leaves at 60 ppm. The tolerance
expression for Taiwan and Japan are harmonized with the US tolerance
definition in crops as parent boscalid only but do not metabolites and
degradates. All international MRLs fall below the calculated tolerance
value of 70 ppm.
C. Revisions to Petitioned-For Tolerances
The petitioned-for tolerance for residues on the commodity tea at
80 ppm is revised so that there will be two separate tolerances for
residues on tea, dried and tea, instant each at 70 ppm and corrected
commodity definitions. The tolerance is also revised pursuant to a
difference in how the tolerances are calculated. The registrant
calculated a processing factor for dried black tea as 4.1x and used the
field trial values from the fresh leaves at 7-days. EPA determined the
processing factor to be no greater than 2.54x and extrapolated the 7-
day residues for black tea based on the combination of the processing
factor and the decline trend for fresh leaves.
V. Conclusion
Therefore, tolerances are established for residues of boscalid, in
or on Tea, dried; and Tea, instant at 70 ppm.
[[Page 44626]]
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). 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: August 2, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.589 amend the table in paragraph (a)(1) by adding in
alphabetical order entries for ``Tea, dried\2\'' and ``Tea, instant
\2\'' to read as follows:
Sec. 180.589 Boscalid; tolerances for residues.
(a) * * *
(1) * * *
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\2\ There are no U.S. registrations for these commodities as of
August 13, 2021.
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Parts per
Commodity million
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* * * * *
Tea, dried \2\.............................................. 70
Tea, instant \2\............................................ 70
* * * * *
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* * * * *
[FR Doc. 2021-16973 Filed 8-12-21; 8:45 am]
BILLING CODE 6560-50-P