[Federal Register Volume 85, Number 139 (Monday, July 20, 2020)]
[Rules and Regulations]
[Pages 43700-43702]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14395]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0523; FRL-10010-91]


Quinclorac; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the tolerance for residues of 
quinclorac in or on rice, grain. BASF Corporation requested this 
tolerance amendment under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective July 20, 2020. Objections and 
requests for hearings must be received on or before September 18, 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-2019-0523, 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 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-2019-0523 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 
September 18, 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-2019-0523, 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 October 28, 2019 (84 FR 57685) (FRL-
10001-11), 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 
9F8770) by BASF Corporation, 26 Davis Drive, Research Triangle Park, 
North Carolina 27709. The petition requested that 40 CFR part 180.463 
be amended by raising the existing tolerance for residues of the 
herbicide quinclorac, in or on rice, grain to 10.0 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. There were no comments 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, by amending 
the tolerance of quinclorac in or on rice, bran to 30 ppm. The reason 
for this change is 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 or amend 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

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give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing or amending 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 
quinclorac including exposure resulting from the tolerance amended by 
this action. EPA's assessment of exposures and risks associated with 
quinclorac follows.
    On December 4, 2017, EPA published in the Federal Register a final 
rule establishing tolerances for residues of quinclorac in or on 
several commodities based on the Agency's conclusion that aggregate 
exposure to quinclorac is safe for the general population, including 
infants and children. See 82 FR 57144 (FRL-9970-05). Because certain 
elements of EPA's safety assessment have not changed since that 
rulemaking, EPA is incorporating by reference portions of that 
rulemaking into this document--in particular, the toxicological profile 
and points of departure, cumulative risk statement, and the Agency's 
determination regarding the children's safety factor. In addition, 
because the residential exposures and drinking water exposures have not 
changed, those sections are also incorporated by reference, but the 
Agency did conduct updated dietary and aggregate risk assessments in 
order to incorporate the higher residues of quinclorac on rice.
    The dietary exposure assessment was updated, assuming 100% crop 
treated (PCT), tolerance-level residues, an empirical processing factor 
(rapeseed oil, 1.5x) and HED's 2018 default processing factors, and the 
highest estimated drinking water concentrations (EDWCs) from acute/
chronic ground water exposure. EPA's aggregate exposure assessment 
incorporated this revised dietary exposure, as well as exposure in 
drinking water and from residential sources, although those latter 
exposures are not impacted by the amended tolerance on rice, grain and 
thus have not changed since the last assessment.
    Acute dietary risks are below the Agency's level of concern: 2.6% 
of the acute population adjusted dose (aPAD) for females age 13 to 49, 
the only population subgroup for which an acute endpoint was selected. 
Chronic dietary risks are below the Agency's level of concern: 11% of 
the chronic population adjusted dose (cPAD) for infants <1 year of age, 
the population subgroup with the highest exposure. Residential handler 
inhalation exposures for adults as well as post-application incidental 
oral exposures for children from registered uses of quinclorac in 
residential areas were assessed previously and no risks of concern were 
identified. Using the exposure assumptions described for short-term 
exposures, EPA has concluded the combined short-term food, water, and 
residential exposures result in aggregate margins of exposures above 
the level of concern of 100 for all scenarios assessed and are not of 
concern. There are no uses resulting in intermediate-term residential 
exposures.
    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 quinclorac residues. Further information about 
EPA's risk assessment and safety analysis for residues of quinclorac 
can be found in the document entitled, ``Quinclorac: Human Health Risk 
Assessment for Rice Commodity Tolerance Increases'' 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-2019-0523.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical methods (gas chromatography/electron capture 
detector (GC/ECD) and liquid chromatography with tandem mass 
spectrometry (LC/MS/MS)) are available for enforcing quinclorac 
tolerances on plant and livestock commodities.

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. Codex has established 
an MRL for quinclorac in or on rice at 10 ppm. This MRL is the same as 
the tolerance amended for quinclorac in the United States. Codex has 
not established an MRL for quinclorac in or on rice bran. Therefore, 
harmonization is not an issue for this commodity.

C. Revisions to Petitioned-For Tolerances

    As a result of the tolerance increase on rice grain, the tolerance 
of the processed commodity rice, bran also needs to be increased. EPA 
used the highest average field trial value for rice reflecting the 
proposed foliar broadcast use, and the rice, bran processing factor to 
determine the needed tolerance of 30 ppm in or on rice, bran.

V. Conclusion

    Therefore, tolerances are modified for residues of quinclorac in or 
on rice, grain to 10 ppm; and rice, bran to 30 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

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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 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: June 12, 2020.
Michael Goodis,
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--[AMENDED]

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.  180.463 amend paragraph (a)(1) by designating the table and 
revising in newly designated Table 1 to paragraph (a)(1) the entries 
for ``Rice, bran'' and ``Rice, grain'' to read as follows:


Sec.  180.463180.463  Quinclorac; tolerances for residues.

    (a)(1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
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                                * * * * *
Rice, bran..............................................              30
Rice, grain.............................................              10
 
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[FR Doc. 2020-14395 Filed 7-17-20; 8:45 am]
BILLING CODE 6560-50-P