[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: 
RDFRNotices@epa.gov.

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: residuemethods@epa.gov.

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]
BILLING CODE 6560-50-P


