[Federal Register Volume 85, Number 187 (Friday, September 25, 2020)]
[Rules and Regulations]
[Pages 60363-60365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19762]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0388; FRL-10013-77]
Saflufenacil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
saflufenacil in or on the caneberry subgroup 13-07A, fig, chia seed and
chia straw. Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective September 25, 2020. Objections and
requests for hearings must be received on or before November 24, 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-2019-0388, 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, 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-2019-0388 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
November 24, 2020. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2019-0388, 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 August 2, 2019 (84 FR 37818) (FRL-9996-
78), 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
9E8763) by IR-4, IR-4 Project Headquarters, Rutgers, The
[[Page 60364]]
State University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition requested the establishment of
tolerances in 40 CFR 180.613(a) for residues of the herbicide
saflufenacil, including its metabolites and degradates, in or on the
following raw agricultural commodities: Caneberry subgroup 13-07A at
0.03 parts per million (ppm), Chia, seed at 1 ppm, Chia, straw at 15
ppm, Fig at 0.03 ppm, and Fig, dried at 0.05 ppm. That document
referenced a summary of the petition prepared by BASF, the registrant,
which is available in the docket, http://www.regulations.gov. No
comments were received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA is
establishing tolerances that vary from what was requested. The reasons
for these changes are 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 saflufenacil including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with saflufenacil follows.
On November 25, 2015, EPA published in the Federal Register a final
rule establishing tolerances for residues of saflufenacil in or on
pomegranate based on the Agency's conclusion that aggregate exposure to
saflufenacil is safe for the general population, including infants and
children. See (80 FR 73663) (FRL-9936-71). EPA is incorporating the
following portions of that document by reference here, as they have not
changed in the Agency's current assessment of saflufenacil tolerances:
The toxicological profile and points of departure, the conclusions
about cumulative risk, and the Agency's determination regarding the
children's safety factor. EPA's dietary (food and drinking water)
exposure assessments have been updated to include the additional
exposure from the new uses of saflufenacil on the caneberry subgroup,
fig, and chia.
The assessment used the same assumptions concerning percent crop
treated and tolerance-level residues and the same estimated drinking
water concentrations as the November 25, 2015 final rule.
Acute dietary risks are below the Agency's level of concern of 100%
of the acute population adjusted dose (aPAD): They are less than 1% of
the aPAD for all infants less than 1 year old, the population subgroup
with the highest exposure estimate. Chronic dietary risks are below the
Agency's level of concern of 100% of the chronic population adjusted
dose (cPAD): They are 20% of the cPAD for all infants less than 1 year
old, the population subgroup with the highest exposure estimate. There
is no short- or intermediate-term exposure expected since there are no
residential uses. Therefore, the acute and chronic aggregate risks
consist only of the dietary risks from food and water and, as stated
above, are below the Agency's level 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 saflufenacil residues. More detailed information
about the Agency's analysis can be found at http://www.regulations.gov
in the document titled ``Saflufenacil. Human Health Risk Assessment in
Support of Tolerances for Residues in/on Pomegranate'' dated November
5, 2015 in docket ID EPA-HQ-OPP-2014-0640 and the document titled
``Saflufenacil. Human Health Draft Risk Assessment for a Petition to
Establish Tolerances for Residues in/on Caneberry Subgroup 13-07A, Fig,
and Chia'' dated August 7, 2020 in docket ID number EPA-HQ-OPP-2019-
0388.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography/mass
spectroscopy/mass spectroscopy (LC/MS/MS) Method D0603/02 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. No Codex MRLs have been
established for saflufenacil on fig, chia and caneberry.
C. Revisions to Petitioned-For Tolerances
The tolerance levels being established by EPA for the caneberry
subgroup 13-07A and fig differ from those proposed by the petitioner
due to differences in calculating the combined limits of quantitation
(LOQs) for residues of saflufenacil and its metabolites. The combined
LOQs of 0.035 ppm were rounded to 0.04 ppm by EPA versus 0.03 ppm by
the petitioner. For chia, EPA is translating from the currently
established tolerances for residues on wheat commodities rather than
barley commodities, resulting in tolerance levels of 0.6 ppm for Chia,
seed and 6 ppm for Chia, straw. Quantifiable residues were found in
dried figs; however, when residues are adjusted for the degree of
exaggeration, the residue value is below the recommended fresh fig
tolerance level (0.04 ppm). A separate tolerance for residues on dried
fig is therefore not required.
[[Page 60365]]
V. Conclusion
Therefore, tolerances are established for residues of saflufenacil
in or on the caneberry subgroup 13-07A at 0.04 ppm; chia, seed at 0.6
ppm; chia, straw at 6 ppm; and fig at 0.04 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 and
modifications 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 25, 2020.
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. 180.649 amend paragraph (a)(1) by designating the table and
adding, alphabetical order, in newly designated Table 1 to paragraph
(a)(1) the entries ``Caneberry subgroup 13-07A''; ``Chia, seed'';
``Chia, straw''; and ``Fig'' to read as follows:
Sec. 180.649 Saflufenacil; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
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Parts per
Commodity million
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* * * * * * *
Caneberry subgroup 13-07A............................... 0.04
Chia, seed.............................................. 0.6
Chia, straw............................................. 6
* * * * * * *
Fig..................................................... 0.04
* * * * * * *
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[FR Doc. 2020-19762 Filed 9-24-20; 8:45 am]
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