[Federal Register Volume 85, Number 101 (Tuesday, May 26, 2020)]
[Rules and Regulations]
[Pages 31383-31386]
[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

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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. 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:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
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;

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:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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,

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.

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


[Federal Register Volume 85, Number 29 (Wednesday, February 12, 2020)]
[Notices]
[Page 8074]
[FR Doc No: 2020-02780]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Rule 104, SEC File No. 270-411, OMB Control No. 3235-0465

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 104 of Regulation M (17
CFR 242.104), under the Securities Exchange Act of 1934 (15 U.S.C. 78a
et seq.). The Commission plans to submit this existing collection of
information to the Office of Management and Budget (``OMB'') for
extension and approval.
    Rule 104--Stabilizing and Other Activities in Connection with an
Offering--permits stabilizing by a distribution participant during a
distribution so long as the distribution participant discloses
information to the market and investors. This rule requires disclosure
in offering materials of the potential stabilizing transactions and
that the distribution participant inform the market when a stabilizing
bid is made. It also requires the distribution participants (i.e., the
syndicate manager) to maintain information regarding syndicate covering
transactions and penalty bids and disclose such information to the
Self-Regulatory Organization (SRO).
    There are approximately 805 respondents per year that require an
aggregate total of 161 hours to comply with this rule. Each respondent
makes an estimated 1 annual response. Each response takes approximately
0.20 hours (12 minutes) to complete. Thus, the total compliance burden
per year is 161 hours. The total estimated internal labor cost of
compliance for the respondents is approximately $11,270.00 per year,
resulting in an estimated internal cost of compliance for each
respondent per response of approximately $14.00 (i.e., $11,270.00/805
respondents).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Cynthia Roscoe, 100 F Street NE, Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>
    Dated: February 7, 2020.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-02780 Filed 2-11-20; 8:45 am]
BILLING CODE 8011-01-P