[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]



40 CFR Part 180

[EPA-HQ-OPP-2020-0050; FRL-8560-01-OCSPP]

Boscalid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


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 

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 

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].


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 
     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 

[[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-
    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:


1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

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) * * *

    \2\ There are no U.S. registrations for these commodities as of 
August 13, 2021.

                                                               Parts per
                          Commodity                             million
                                * * * * *
Tea, dried \2\..............................................          70
Tea, instant \2\............................................          70
                                * * * * *

* * * * *
[FR Doc. 2021-16973 Filed 8-12-21; 8:45 am]