[Federal Register Volume 85, Number 205 (Thursday, October 22, 2020)]
[Rules and Regulations]
[Pages 67285-67288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23400]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0281; FRL-10015-25]
Clofentezine; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
clofentezine in or on hop, dried cones. The Interregional Project
Number 4 (IR-4) requested this tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective October 22, 2020. Objections and
requests for hearings must be received on or before December 21, 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-2019-0281, 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, Acting Director,
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
Printing 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-2019-0281 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
December 21, 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-2019-0281, 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 https://www.epa.gov/dockets/where-send-comments-epa-dockets. 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
9E8752) 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 180.446 be amended by establishing a tolerance
for residues of the insecticide clofentezine, 3,6-bis(2-chlorophenyl)-
1,2,4,5-tetrazine, in or on hop, dried cones at 6 parts per million
(ppm). That document referenced a summary of the petition prepared by
Makhteshim Agan of North America (d/b/a ADAMA), the
[[Page 67286]]
registrant, which is available in docket number EPA-HQ-OPP-2019-0281 at
http://www.regulations.gov. One comment was received on the notice of
filing. EPA's response to the comment is discussed in Unit IV.C.
In accordance with section 408(d)(4)(a)(i), which permits the
Agency to finalize a tolerance that varies from that sought by the
petition, and based upon review of the data supporting the petition,
EPA has established a tolerance for residues of clofentezine on hop,
dried cones at 7 ppm, rather than 6 ppm as requested. The reason for
this change is explained in Unit IV.D.
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 clofentezine including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with clofentezine follows.
On May 29, 2019, EPA published in the Federal Register a final rule
establishing tolerances for residues of clofentezine in or on guava
based on the Agency's conclusion that aggregate exposure to
clofentezine is safe for the general population, including infants and
children. See 84 FR 24722 (FRL-9993-48) (EPA-HQ-OPP-2018-0275). EPA is
incorporating the following portions of that document by reference
here, as they have not changed in the Agency's current assessment: The
cancer classification and conclusion that it is appropriate to assess
cancer risk estimates using a linear low-dose extrapolation approach,
and the conclusions about cumulative risk. Additionally, EPA is
incorporating the assumptions for exposure assessment from the May 29,
2019, final rule, which have not changed except as explained in the
following paragraphs.
EPA is incorporating most of the toxicological profile from the May
29, 2019, rule with the following amendments. Since that rule was
issued, EPA has determined that a comparative thyroid assay (CTA) is
needed. In the absence of the CTA, EPA has determined that the FQPA
safety factor is retained (as a database uncertainty factor of 10X is
applied for all exposure scenarios). Additionally, EPA has revised the
dermal absorption factor for clofentezine from 10% to 2% based on
additional data that have been submitted, reviewed and incorporated
into the assessment. EPA is incorporating the points of departure from
the June 14, 2016, Federal Register (81 FR 38604, FRL-9942-23) (EPA-HQ-
OPP-2014-0749) which have not changed. However, the chronic reference
dose and the chronic population adjusted dose have changed due to the
inclusion of the database uncertainty factor. It should be noted that
an acute dietary exposure and risk analysis was not performed since no
toxicological effect was observed from acute (single) dose exposure via
the dietary route that demonstrated evidence of toxicity attributable
to a single dose for either the general population or for females 13-49
years of age.
EPA's dietary (food and drinking water) exposure assessments have
been updated to include the additional exposure from the new use of
clofentezine on hops. EPA conducted a partially refined chronic dietary
(food and drinking water) exposure and risk assessment that
incorporates average field trial residues, percent crop treated
information that has been updated since the last assessment, and
modelled drinking water estimated residues. The drinking water exposure
is not impacted by the new use and thus has not changed since the last
assessment from May 29, 2019.
An acute dietary endpoint (i.e., single dose endpoint) for risk
assessment was not identified in the toxicity database for the general
U.S. population or any other subpopulation for clofentezine; therefore,
an acute dietary exposure assessment was not conducted. Chronic dietary
risks are below the Agency's level of concern (LOC) of 100% of the
chronic population adjusted dose (cPAD); they are estimated to be 6% of
the cPAD for all infants less than 1 year old, the group with the
highest exposure.
There are no registered residential uses of clofentezine;
therefore, the chronic aggregate risk assessment only includes dietary
risk, which is not of concern. Because there is no short- or
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the point of departure used to assess short-
or intermediate-term risk), no further assessment of short- or
intermediate-term risk is necessary. Thus, EPA relies on the chronic
dietary risk assessment for the aggregate risk assessment.
Applying the Q1* of 3.76 x 10-2 (mg/kg/
day)-1 to the exposure value results in a cancer risk
estimate of 1.7 x 10-6 for adults 20-49 years old, the most
highly exposed adult population subgroup. EPA generally considers
cancer risks (expressed as the probability of an increased cancer case)
in the range of 1 in 1 million (or 1 x 10-6) or less to be
negligible. The precision which can be assumed for cancer risk
estimates is best described by rounding to the nearest integral order
of magnitude on the logarithmic scale; for example, risks falling
between 3 x 10-7 and 3 x 10-6 are expressed as
risks in the range of 10-6. Considering the precision with
which cancer hazard can be estimated, the conservativeness of low-dose
linear extrapolation, and the rounding procedure described above,
cancer risk should generally not be assumed to exceed the benchmark
level of concern of the range of 10-6 until the calculated
risk exceeds approximately 3 x 10-6. This is particularly
the case where some conservatism is maintained in the exposure
assessment. Although the clofentezine exposure assessment is partially
refined, it retains significant conservatism in that field trial data
and not market basket data is used in estimating exposure to existing
uses as well as this new use. In addition, EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to clofentezine in drinking water. These assessments
will not underestimate the exposure posed by clofentezine. Accordingly,
EPA has concluded the aggregate cancer risk for all existing
clofentezine uses and the new hops use in this action fall within the
range of 1 x 10-6 and are thus negligible.
[[Page 67287]]
Therefore, 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 clofentezine residues. More detailed
information can be found in the documents entitled, ``Clofentezine.
Human Health Risk Assessment to Support a Section 3 New Use on Hops,''
in docket ID, EPA-HQ-OPP-2019-0281 and ``Clofentezine. Human-Health
Risk Assessment to Support a Section 3 New Uses on Guava,'' dated May
13, 2019, in docket ID, EPA-HQ-OPP-2018-0275.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate analytical method (high-performance liquid
chromatography (HPLC)) is available to enforce the tolerances for
clofentezine 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 has not established MRLs for clofentezine
on hop, dried cones.
C. Response to Comments
EPA received one comment requesting the EPA to establish specific
pesticide tolerances for Cypermethrin, Pendimethalin and Chlorpyrifos
for Crop Subgroup 4B (Leaf petioles subgroup) and Crop Subgroup 22B
(Leaf petiole vegetable subgroup), as well as to name Celery and Celery
Leaves (Fresh and dried) specifically as a represented commodity. This
comment is unrelated to this docket and final rule and the comment does
not meet the requirements for a pesticide tolerance petition that are
set out in 40 CFR 180.7.
D. Revisions to Petitioned-for Tolerances
The Agency is establishing a tolerance for residues of clofentezine
on hop, dried cones at 7 ppm, rather than 6 ppm as requested. The 2016
storage stability data showed a decline in storage stability, but the
2018 data did not. Therefore, only the five field trials from the 2018
data were used to establish the tolerance.
V. Conclusion
Therefore, tolerances are established for residues of clofentezine,
3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine, in or on Hop, dried cones at
7 parts per million (ppm).
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to petitions 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 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: October 16, 2020.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, the EPA amends
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. 180.446, amend paragraph (a)(1) by adding to the table, in
alphabetical order, the commodity ``Hop, dried cones'' to read as
follows:
Sec. 180.446 Clofentezine; tolerances for residues.
(a) * * *
(1) * * *
[[Page 67288]]
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Parts per
Commodity million
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* * * * *
Hop, dried cones........................................ 7
* * * * *
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[FR Doc. 2020-23400 Filed 10-21-20; 8:45 am]
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