[Federal Register Volume 85, Number 101 (Tuesday, May 26, 2020)]
[Rules and Regulations]
[Pages 31383-31386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10331]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0297; FRL-10008-50]


Chlormequat Chloride; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends a tolerance for residues of chlormequat 
chloride in or on oat grain. Taminco US LLC, a subsidiary of Eastman 
Chemical Company, requested this amendment under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 26, 2020. Objections and 
requests for

[[Page 31384]]

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-2019-0297, 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 review the visitor instructions and 
additional information about the docket available at http://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: 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 
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-2019-0297 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-2019-0297, 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 June 28, 2019 (84 FR 30976) (FRL-9995-
27), 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 
9F8758) by Taminco US LLC, a subsidiary of Eastman Chemical Company, 
200 S Wilcox Drive, Kingsport, TN 37660-5147. The petition requested 
that 40 CFR 180.698 be amended by modifying the tolerance for residues 
of the plant regulator, chlormequat chloride, in or on the raw 
agricultural commodity oat, grain from 10 parts per million (ppm) to 
30.0 ppm. That document referenced a summary of the petition prepared 
by Taminco US LLC, the registrant, which is available in the docket, 
http://www.regulations.gov. A comment was received in response to the 
notice of filing. EPA's response to this comment is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified the level to which the tolerance is being amended. 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 chlormequat chloride including 
exposure resulting from the tolerance modified by this action. EPA's 
assessment of exposures and risks associated with chlormequat chloride 
follows.
    On April 25, 2018, EPA published in the Federal Register a final 
rule establishing tolerances for residues of chlormequat chloride in or 
on barley, grain; cattle, meat byproduct; cattle, meat; egg; goat, meat 
byproduct; goat, meat; hog, meat byproduct; hog, meat;

[[Page 31385]]

milk; oat, grain; poultry, meat byproduct; poultry, meat; sheep, meat 
byproduct; sheep, meat; and wheat, grain based on the Agency's 
conclusion that aggregate exposure to chlormequat chloride is safe for 
the general population, including infants and children. See 83 FR 17925 
(FRL-9974-42). That document contains a summary of the toxicological 
profile and points of departure, assumptions for exposure assessment, 
and the Agency's determination regarding the children's safety factor, 
which have not changed.
    EPA's dietary exposure assessments have been updated to include the 
potential additional exposure from the increased tolerance of 
chlormequat chloride on oat grain, i.e., reliance on tolerance-level 
residues for all crops, and an assumption of 100 percent crop treated 
(PCT). EPA's aggregate exposure assessment incorporated this additional 
assumed dietary exposure, as well as exposure in drinking water and 
from residential sources, although those latter exposures are not 
impacted by the increased tolerance on oat grain and thus have not 
changed since the last assessment. Further information about EPA's risk 
assessment and determination of safety supporting the tolerances 
established in the April 25, 2018 Federal Register action, as well as 
the amended chlormequat chloride tolerance, can be found at http://www.regulations.gov in the document titled, ``Chlormequat Chloride. 
Human-Health Risk Assessment to Support Establishment of a Tolerance 
Without U.S. Registration on Wheat, Barley, and Oats,'' dated February 
27, 2018 in docket ID number EPA-HQ-OPP-2016-0661 and the document 
titled, ``Chlormequat Chloride. Human Health Risk Assessment to Support 
Tolerance Amendment for Residues in/on Imported Oat Grains,'' dated 
April 14, 2020 in docket ID number EPA-HQ-OPP-2019-0297.
    Acute aggregate dietary risks (food and water) are below the 
Agency's level of concern of 100% of the acute population adjusted 
dose: 52% of the aPAD at the 95th percentile of exposure 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): 72% 
of the cPAD for children 1 to 2 years old, the population subgroup with 
the highest exposure estimate. There are no residential uses for 
chlormequat chloride; therefore, no aggregate short- or intermediate-
term assessment was necessary.
    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 chlormequat chloride residues. More detailed 
information on the subject action to modify the oat grain tolerance can 
be found in the document entitled, ``Chlormequat Chloride. Human Health 
Risk Assessment to Support Tolerance Amendment for Residues in/on 
Imported Oat Grains'' 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-2019-0297.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate high-performance liquid chromatography method with 
tandem mass spectrometry detection (HPLC/MS/MS), BASF Method No. 530/0, 
is available for the determination of residues of chlormequat chloride 
in/on plant commodities. An adequate LC/MS/MS method, BASF Method No. 
397/0 is available for the determination of residues of chlormequat 
chloride in livestock commodities for enforcement purposes.
    The methods 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 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.
    There is an established Codex MRL for chlormequat chloride in/on 
oat grains at 4 ppm. Based on the oat grain residue from the field 
trials (40 ppm), harmonization with the Codex MRL is not possible.

C. Response to Comments

    One comment was received to the notice of filing that stated in 
part that ``this shoudl [sic] be denied. it shudl [sic] be 
disapproved.''
    Although the Agency recognizes that some individuals believe that 
pesticides should be banned on agricultural crops, the existing legal 
framework provided by section 408 of the Federal Food, Drug and 
Cosmetic Act (FFDCA) authorizes EPA to establish tolerances when it 
determines that the tolerance is safe. Upon consideration of the 
validity, completeness, and reliability of the available data as well 
as other factors the FFDCA requires EPA to consider, EPA has determined 
that this chlormequat chloride tolerance is safe. The commenter has 
provided no information supporting a contrary conclusion.

D. Revisions to Petitioned-For Tolerances

    The petitioner requested the oat, grain tolerance be amended from 
10 ppm to 30.0 ppm. The analytical method detected chlormequat cation; 
therefore, the residues were converted to chlormequat chloride 
equivalents using a molecular weight conversion factor (MWCF) of 1.29. 
The petitioner-proposed tolerances on oat grains are without the MWCF; 
therefore, the Agency has determined that the tolerance needs to be 
higher. Additionally, the Agency is harmonizing the tolerance level 
with the MRL that is currently being established by Canada.

V. Conclusion

    Therefore, the tolerance for residues of chlormequat chloride in or 
on oat, grain is amended from 10 ppm to 40 ppm.

VI. Statutory and Executive Order Reviews

    This action amends a tolerance 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,

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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: 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.


0
2. In Sec.  180.698, revise the entry for ``Oat, grain'' and the 
footnote in paragraph (a) to read as follows:


Sec.  180.698  Chlormequat chloride; tolerances for residues.

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------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Oat, grain \2\..........................................              40
 
                               * * * * *
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\2\ There are no U.S. registrations for this commodity.

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[FR Doc. 2020-10331 Filed 5-22-20; 8:45 am]
BILLING CODE 6560-50-P


