[Federal Register Volume 85, Number 103 (Thursday, May 28, 2020)]
[Rules and Regulations]
[Pages 31983-31986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10565]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0250; FRL-10009-26]
Flonicamid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation revises the tolerance for residues of
flonicamid in or on Leafy greens subgroup 4-16A, except spinach.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 28, 2020. Objections and
requests for hearings must be received on or before July 27, 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-2019-0250, 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.
Please note that due to the public health emergency, the EPA Docket
Center (EPA/DC) and Reading Room was closed to public visitors on March
31, 2020. Our EPA/DC staff will continue to provide customer service
via email, phone, and webform. For further information on EPA/DC
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at 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
[[Page 31984]]
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-2019-0250 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 July 27, 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-2019-0250, 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
9E8743) by IR-4, Rutgers, The State University of New Jersey, 500
College Road East, Suite 201 W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.613 be amended by increasing the existing
tolerance for residues of the insecticide flonicamid, including its
metabolites and degradates, to be determined by measuring only the sum
of flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-
pyridinecarboxamide, and its metabolites, TFNA (4-
trifluoromethylnicotinic acid), TFNA-AM (4-
trifluoromethylnicotinamide), and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric
equivalent of flonicamid, in or on Leafy greens subgroup 4-16A, except
spinach, from 4.0 parts per million (ppm) to 8.0 ppm. That document
referenced a summary of the petition prepared by ISK Biosciences
Corporation, the registrant, for IR-4 which is available in the docket,
http://www.regulations.gov. One comment was received on the notice of
filing. EPA's response to this comment is discussed in Unit IV.C.
EPA is establishing the tolerance at 8 ppm rather than 8.0 ppm to
be consistent with the Organization for Economic Cooperation and
Development (OECD) Rounding Class Practice.
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 flonicamid including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with flonicamid follows.
On April 8, 2019, EPA published in the Federal Register a final
rule establishing tolerances for residues of flonicamid on sunflower
subgroup 20B based on the Agency's conclusion that aggregate exposure
to flonicamid is safe for the general population, including infants and
children. See 84 FR 13805 (FRL-9990-52). That document contains a short
discussion of the toxicological profile, assumptions for exposure
assessment, cumulative risk, and Agency's determination regarding the
children's safety factor, which have not changed. In addition, the
April 8, 2019 final rule referred to a summary of the toxicological
profile and the toxicological endpoints and the points of departure for
flonicamid used for human risk assessment in Unit III.B. of the final
rule published in the Federal Register of July 23, 2018 (83 FR 34775)
(FRL-9977-82). Those discussions are also incorporated here, as they
have not changed since those documents were published.
EPA's exposure assessments have been updated to include the
additional exposure from use of flonicamid in greenhouses on
commodities in the Leafy greens subgroup 4-16A, except spinach. EPA
relied on tolerance-level residues and an assumption of 100 percent
crop treated for all commodities. EPA's aggregate exposure assessment
incorporated this additional dietary exposure, as well as exposure in
drinking water, although the drinking water exposures are not impacted
by this new greenhouse use and thus have not changed since the last
assessment. Flonicamid is not registered for any specific use patterns
that would result in residential exposure. Further information about
EPA's risk assessment and determination of safety supporting the
tolerances established in the April 8, 2019 Federal Register action, as
well as the new flonicamid tolerance can be found at http://www.regulations.gov in ``Flonicamid. Human Health Risk Assessment for
the Establishment of Permanent Tolerances in or on Sunflower Subgroup
20B,'' dated December 6, 2018 in docket ID number EPA-HQ-OPP-2018-0273
and the document titled, ``Flonicamid. Human Health Risk Assessment for
a Petition to Increase the Tolerance for Leafy Greens, Except Spinach
(Subgroup 4-16A) to Support Use on Greenhouse-Grown Commodities,''
dated April 28, 2020 in docket ID number EPA-HQ-OPP-2019-0250.
No adverse effects resulting from a single oral exposure was
identified and no acute dietary endpoint was selected; therefore, an
acute dietary assessment was not conducted. Chronic dietary risks are
below the Agency's level of concern: 62% of the chronic population-
adjusted dose (cPAD) for children 1 to
[[Page 31985]]
2 years old, the group with the highest exposure. Flonicamid is not
registered for any use patterns that would result in short- or
intermediate-term residential exposures. EPA has concluded that the
cPAD is protective of possible cancer effects from flonicamid. Because
aggregate exposure to flonicamid is below the cPAD, EPA concludes that
there is not an aggregate cancer risk from exposures to flonicamid.
Therefore, based on these 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 infants and
children from aggregate exposure to flonicamid residues. More detailed
information on the subject action to revise the tolerance in or on the
Leafy greens subgroup 4-16A, except spinach, can be found in the
document entitled, ``Flonicamid. Human Health Risk Assessment for a
Petition to Increase the Tolerance for Leafy Greens, Except Spinach
(Subgroup 4-16A) to Support Use on Greenhouse-Grown Commodities'' by
going to http://www.regulations.gov. The referenced document is
available in the docket established by this action, which is described
under ADDRESSES. Locate and click on the hyperlink for docket ID number
EPA-HQ-OPP-2019-0250.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology is available to enforce the
tolerance expression. FMC Method No. P-3561M, a liquid chromatography-
tandem mass spectrometry (LC/MS/MS) method, is an acceptable
enforcement method for flonicamid and its metabolites in plant
commodities.
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 established MRLs for flonicamid in or on leaf lettuce
at 8.0 ppm and head lettuce at 1.5 ppm. No other Codex MRLs are
established for the crops within this subgroup. While the tolerance
expression for U.S. flonicamid tolerances is different than the
expression for the Codex flonicamid MRLs, the level of the new U.S.
tolerance for Leafy greens subgroup 4-16A, except spinach, is
harmonized with the Codex MRL for leaf lettuce. Because the U.S.
tolerance is for a crop subgroup, it not possible to harmonize with the
Codex MRL for head lettuce, which is another commodity in the Leafy
greens subgroup 4-16A.
C. Response to Comments
One commenter opposed approval of this tolerance claiming it could
have detrimental effects on beneficial insects. Whether a pesticide has
detrimental effects on beneficial insects, however, is a question
outside the scope of analysis under the FFDCA because it is not
relevant to whether tolerances are safe. The existing legal framework
provided by section 408 of the FFDCA states that tolerances may be set
when persons seeking such tolerances or exemptions have demonstrated
that the pesticide meets the safety standard imposed by that statute.
This comment provides no information relevant the Agency's safety
determination. Concerns about environmental impacts of a pesticide are
more appropriately raised in actions related to pesticides being
registered under the Federal Insecticide, Fungicide and Rodenticide
Act.
V. Conclusion
Therefore, the existing tolerance for residues of flonicamid,
including its metabolites and degradates, in or on Leafy greens
subgroup 4-16A, except spinach, is modified to be 8 ppm, rather than
4.0 ppm.
VI. Statutory and Executive Order Reviews
This action modifies 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
[[Page 31986]]
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 6, 2020.
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.
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2. In Sec. 180.613, revise the entry ``Leafy greens subgroup 4-16A,
except spinach'' in the table in paragraph (a)(1) to read as follows:
Sec. 180.613 Flonicamid; tolerances for residues.
(a) * * *
(1) * * *
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Parts per
Commodity million
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* * * * *
Leafy greens subgroup 4-16A, except spinach................. 8
* * * * *
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[FR Doc. 2020-10565 Filed 5-27-20; 8:45 am]
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