[Federal Register Volume 80, Number 241 (Wednesday, December 16, 2015)]
[Notices]
[Pages 78224-78225]
[FR Doc No: 2015-31540]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2011-0439; FRL 9939-81-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Disinfectants/Disinfection Byproducts,
Chemical and Radionuclides Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) has submitted
an Information Collection Request (ICR) for the Disinfectants/
Disinfection Byproducts, Chemical and Radionuclides Rules (EPA ICR No.
1896.10, OMB Control No. 2040-0204) to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act (PRA; 44 U.S.C. 3501 et seq.). This is a proposed
extension of the ICR, which is currently approved through December 31,
2015. Public comments were previously requested via the Federal
Register (80 FR 17040) on March 31, 2015, during a 60-day comment
period. This notice allows for an additional 30 days for public
comments. A description of the ICR is provided in this renewal notice,
including its estimated burden and cost to the public. An Agency may
not conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.

DATES: Additional comments may be submitted on or before January 15,
2016.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OW-2011-0439, to (1) EPA online using www.regulations.gov (our
preferred method), by email to<EMAIL_ADDRESS>or by mail to EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without modification including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Kevin Roland, Drinking Water

Protection Division, Office of Ground Water and Drinking Water,
(4606M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov, or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: The Disinfectants/Disinfection Byproducts, Chemical and
Radionuclides Rules ICR examines public water systems' and primacy
agencies' burden and costs for recordkeeping and reporting requirements
in support of the chemical drinking water regulations. These
recordkeeping and reporting requirements are mandatory for compliance
with the Code of Federal Regulations (CFR) at 40 CFR parts 141 and 142.
The following chemical regulations are included: The Stage 1
Disinfectants and Disinfection Byproducts Rule (Stage 1 DBPR), the
Stage 2 Disinfectants and Disinfection Byproducts Rule (Stage 2 DBPR),
the Chemical Phase Rules (Phases II/IIB/V), the Radionuclides Rule, the
Disinfectant Residual Monitoring and Associated Activities under the
Surface Water Treatment Rule (SWTR), the Arsenic Rule and the Lead and
Copper Rule (LCR). Future chemical-related rulemakings will be added to
this consolidated ICR after the regulations are promulgated and the
initial, rule-specific, ICRs are due to expire.
    Form Numbers: None.
    Respondents/affected entities: Entities potentially affected by
this action are new and existing public water systems and primacy
agencies.
    Respondent's obligation to respond: Mandatory for compliance with
40 CFR parts 141 and 142.
    Estimated number of respondents: 149,822.
    Frequency of response: Varies by requirement (i.e., on occasion,
monthly, quarterly, semi-annually, annually, biennially, and every 3, 6
and 9 years).
    Total estimated burden: 5,305,696 hours (per year). Burden is
defined in 5 CFR 1320.03(b).
    Total estimated cost: $464,896,000 (per year), includes $5,492,000
annualized capital costs and $253,440,000 operation and maintenance
costs.
    Changes in the Estimates: There is a decrease of 428,639 hours in
the total estimated respondent burden compared with the ICR currently
approved by OMB. This decrease is a result of updating relevant
baseline information for each rule with the most current and accurate
information available and updating burden to incorporate the results of
consultation with stakeholders. Estimated violation and other
associated rates have also been updated to reflect current information
on rule compliance.

Courtney Kerwin,
Acting Director, Collection Strategies Division.
[FR Doc. 2015-31540 Filed 12-15-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 210 (Wednesday, November 1, 2017)]
[Notices]
[Page 50661]
[FR Doc No: 2017-23718]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3381-EM: ID FEMA-2017-0001]

California; Amendment No. 1 to Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of an emergency declaration for
the State of California (FEMA-3381-EM), dated February 14, 2017, and
related determinations.

DATES: This amendment was issued October 20, 2017.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this emergency is closed effective February 23, 2017.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-23718 Filed 10-31-17; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 88, Number 84 (Tuesday, May 2, 2023)]
[Notices]
[Pages 27549-27551]
[FR Doc No: 2023-09209]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97385; File No. SR-Phlx-2023-13]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Extend Certain
Pilot Programs

April 26, 2023.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 14, 2023, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to extend the pilot to permit the listing and
trading of options based on 1/100 the value of the Nasdaq-100 Index
(``Nasdaq-100'') and the Exchange's nonstandard expirations pilot
program, both currently set to expire on May 4, 2023.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/phlx/rules, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Phlx proposes to extend 2 pilots, which are both set to expire on
May 4, 2023. The Exchange proposes to extend (1) pilot to permit the
listing and trading of options based on 1/100 the value of the Nasdaq-
100 Index (``XND Pilot''), and (2) the Exchange's nonstandard
expirations pilot program (``Nonstandard Pilot'').
XND Pilot
    Phlx filed a rule change to permit the listing and trading of index
options on the Nasdaq 100 Micro Index Options (``XND'') on a pilot
basis.\3\ XND options trade independently of and in addition to NDX
options, and the XND options are subject to the same rules that
presently govern the trading of index options based on the Nasdaq-100
Index, including sales practice rules, margin requirements, trading
rules, and position and exercise limits. Similar to NDX, XND options
are European-style and cash-settled, and have a contract multiplier of
100. The contract specifications for XND options mirror in all respects
those of the NDX options contract already listed on the Exchange,
except that XND options are based on 1/100th of the value of the
Nasdaq-100 Index, and are P.M.-settled pursuant to Options 4A, Section
12(a)(5).
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    \3\ See Securities Exchange Act Release No. 91524 (April 9,
2021), 86 FR 19909 (April 15, 2021) (SR-Phlx-2021-07) (Approval
Order).
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    The Exchange proposes to amend Phlx Options 4A, Section 12(a)(6) to
extend the current XND Pilot period to November 6, 2023. This pilot was
previously extended and is currently extended through May 4, 2023.\4\
The Exchange continues to have sufficient capacity to handle additional
quotations and message traffic associated with the listing and trading
of XND options. In addition, index options are integrated into the
Exchange's existing surveillance system architecture and are thus
subject to the relevant surveillance processes. The Exchange also
continues to have adequate surveillance procedures to monitor trading
in XND options thereby aiding in the maintenance of a fair and orderly
market. Additionally, there is continued investor interest in these
products and this extension will provide additional time to collect
data related to the XND Pilot. The Exchange believes that the proposed
extension of the XND Pilot will not have an adverse impact on capacity.
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    \4\ See Securities Exchange Act Release No. 93447 (October 28,
2021), 86 FR 60719 (November 3, 2021) (SR-Phlx-2021-66); 94631
(April 7, 2022), 87 FR 21990 (April 13, 2022) (SR-Phlx-2022-16); and
95993 (October 6, 2022), 87 FR 62161 (October 13, 2022) (SR-Phlx-
2022-39).
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XND Pilot Report
    The Exchange currently makes public on its website the data and
analysis previously submitted to the Commission on the XND Pilot and
will continue to make public any data or analysis it submits under the
XND Pilot in the future. The Exchange has filed a rule change proposing
permanency of the XND Pilot.\5\ The Exchange continues to provide
monthly data and has provided additional data in the permanency filing.
The Exchange would continue to provide the Commission with ongoing data
unless and until the XND Pilot is made permanent or discontinued.
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    \5\ See Securities Exchange Act Release No. 96980 (February 24,
2023), 88 FR 13161 (March 2, 2023) (SR-Phlx-2023-07).
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Nonstandard Pilot
    On December 15, 2017, the Commission approved a rule change for the
listing and trading on the Exchange, on a twelve month pilot basis, of
p.m.-settled options on broad-based indexes with nonstandard
expirations dates (``Nonstandard Pilot'').\6\ The Nonstandard Pilot
permits both Weekly Expirations and End of Month (``EOM'') expirations
similar to those of the a.m.-settled broad-based index options, except
that the exercise settlement value of the options subject to the pilot
are based on the index value derived from the closing prices of
component stocks. On July 29, 2022, the Commission approved a Proposed
Rule Change To Permit the Listing and Trading of P.M.-Settled Nasdaq-
100 Index Options That Expire on Tuesday or Thursday Under Its
Nonstandard Expirations Pilot Program.\7\ The Nonstandard Pilot was
extended various times and is currently extended through May 4,
2023.\8\
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    \6\ See Securities Exchange Act Release No. 82341 (December 15,
2017), 82 FR 60651 (December 21, 2017) (Notice of Filing of
Amendment No. 2, Order Approving a Proposed Rule Change, as Modified
by Amendment No. 1 and Granting Accelerated Approval of Amendment
No. 2, of a Proposed Rule Change To Establish a Nonstandard
Expirations Pilot Program).
    \7\ See Securities Exchange Act Release No. 95391 (July 29,
2022), 87 FR 47797 (August 4, 2022) (SR-Phlx-2022-22) (Order
Granting Approval of a Proposed Rule Change To Permit the Listing
and Trading of P.M.-Settled Nasdaq-100 Index Options That Expire on
Tuesday or Thursday Under Its Nonstandard Expirations Pilot
Program).
    \8\ See Securities Exchange Act Release Nos. 84835 (December 17,
2018), 83 FR 65773 (December 21, 2018) (SR-Phlx-2018-80); 85669
(April 17, 2019), 84 FR 16913 (April 23, 2019) (SR-Phlx-2019-13);
87381 (October 22, 2019), 84 FR 57788 (October 28,2 019) (SR-Phlx-
2019-43); 88684 (April 17, 2020), 85 FR 22781 (April 23, 2020) (SR-
Phlx-2020-24); 90256 (October 22, 2020), 85 FR 68393 (October 28,
2020) (SR-Phlx-2020-48); 91484 (April 6, 2021), 86 FR 19050 (April
12, 2021) (SR-Phlx-2021-21); 93464 (October 29, 2021), 86 FR 60952
(November 4, 2021) (SR-Phlx-2021-65); 94631 (April 7, 2022), 87 FR
21990 (April 13, 2022) (SR-Phlx-2022-16); and 95993 (October 6,
2022), 87 FR 62161 (October 13, 2022) (SR-Phlx-2022-39).

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    Pursuant to Phlx Options 4A, Section 12(b)(5)(A) the Exchange may
open for trading Weekly Expirations on any broad-based index eligible
for standard options trading to expire on any Monday, Wednesday, or
Friday (other than the third Friday-of-the-month or days that coincide
with an EOM expiration). In addition, the Exchange may also open for
trading Weekly Expirations on Nasdaq-100 Index options to expire on any
Tuesday or Thursday (other than days that coincide with the third
Friday-of-the-month or an EOM expiration). Weekly Expirations are
subject to all provisions of Options 4A, Section 12 and are treated the
same as options on the same underlying index that expire on the third
Friday of the expiration month. Unlike the standard monthly options,
however, Weekly Expirations are p.m.-settled.
    Similarly, pursuant to Options 4A, Section 12(b)(5)(B) the Exchange
may open for trading EOM expirations on any broad-based index eligible
for standard options trading to expire on the last trading day of the
month. EOM expirations are subject to all provisions of Options 4A,
Section 12 and treated the same as options on the same underlying index
that expire on the third Friday of the expiration month. However, the
EOM expirations are p.m.-settled.
    The Exchange now proposes to amend Options 4A, Section 12(b)(5)(C)
so that the duration of the Nonstandard Pilot for these nonstandard
expirations will be through November 6, 2023. The Exchange continues to
have sufficient systems capacity to handle p.m.-settled options on
broad-based indexes with nonstandard expirations dates and has not
encountered any issues or adverse market effects as a result of listing
them. Additionally, there is continued investor interest in these
products. The Exchange will continue to make public on its website any
data and analysis it submits to the Commission under the Nonstandard
Pilot. The Exchange believes that the proposed extension of the
Nonstandard Pilot will not have an adverse impact on capacity.
Nonstandard Pilot Report
    The Exchange submitted a rule change proposing permanency of the
Nonstandard Pilot.\9\ The Exchange continues to provide monthly data
and has provided additional data in the permanency filing. The Exchange
would continue to provide the Commission with ongoing data unless and
until the Nonstandard Pilot is made permanent or discontinued.
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    \9\ See Securities Exchange Act Release No. 96980 (February 24,
2023), 88 FR 13161 (March 2, 2023) (SR-Phlx-2023-07).
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\10\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\11\ in particular, in that it
is designed to promote just and equitable principles of trade, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and, in general to protect
investors and the public interest.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
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XND Pilot
    In particular, the Exchange believes that the XND Pilot has been
successful to date. The Exchange has not encountered any problems with
the XND Pilot. By extending the XND Pilot, the Exchange believes it
will attract order flow to the Exchange, increase the variety of listed
options, and provide a valuable hedge tool to retail and other
investors. Specifically, the Exchange believes that the XND Pilot will
provide additional trading and hedging opportunities for investors
while providing the Commission with data to monitor for and assess any
potential for adverse market effects of allowing P.M.-settlement for
XND options, including on the underlying component stocks.
Nonstandard Pilot
    The Exchange believes the proposed rule change will protect
investors and the public interest by providing the Exchange, the
Commission and investors the benefit of additional time to analyze
nonstandard expiration options. In particular, the Exchange believes
that the Nonstandard Pilot has been successful to date. The Exchange
has not encountered any problems with the Nonstandard Pilot. By
extending the Nonstandard Pilot, investors may continue to benefit from
a wider array of investment opportunities. Additionally, both the
Exchange and the Commission may continue to monitor the pilot for
potential adverse market effects of p.m.-settlement on the market,
including the underlying cash equities market, at the expiration of
these options.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
the proposed rule change will not impose an undue burden on inter-
market competition as this rule change will continue to facilitate the
listing and trading of new option products that will enhance
competition among market participants, to the benefit of investors and
the marketplace. Furthermore, these products could offer a competitive
alternative to other existing investment products. Finally, it is
possible for other exchanges to develop or license the use of a new or
different index to compete with these products and seek Commission
approval to list and trade options on such an index.
XND Pilot
    XND options would be available for trading to all market
participants and therefore would not impose an undue burden on intra-
market competition. The continued listing of XND will enhance
competition by providing investors with an additional investment
vehicle, in a fully-electronic trading environment, through which
investors can gain and hedge exposure to the Nasdaq-100.
Nonstandard Pilot
    Options with nonstandard expirations would be available for trading
to all market participants. The continued listing of the Nonstandard
Pilot will enhance competition by providing investors with an
additional investment vehicle, in a fully-electronic trading
environment, through which investors can gain and hedge exposure to the
Nasdaq-100.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the proposed rule change does not: (i) significantly affect
the protection of investors or the public

interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \12\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\13\
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    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6). In addition, Rule19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) \14\ normally
does not become operative prior to 30 days after the date of the
filing. However, Rule 19b-4(f)(6)(iii) \15\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Exchange states that
waiver of the 30-day operative delay will allow it to extend the pilot
programs prior to their expiration on May 4, 2023, permitting the pilot
programs to continue uninterrupted. The Commission believes that
waiving the 30-day operative delay is consistent with the protection of
investors and the public interest because the proposed rule change does
not raise any new or novel issues. Accordingly, the Commission hereby
waives the 30-day operative delay and designates the proposed rule
change as operative upon filing.\16\
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    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 17 CFR 240.19b-4(f)(6)(iii).
    \16\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-Phlx-2023-13 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2023-13. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (https://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. Do
not include personal identifiable information in submissions; you
should submit only information that you wish to make available
publicly. We may redact in part or withhold entirely from publication
submitted material that is obscene or subject to copyright protection.
All submissions should refer to File Number SR-Phlx-2023-13, and should
be submitted on or before May 23, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12), (59).
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Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-09209 Filed 5-1-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 240 (Thursday, December 15, 2022)]
[Notices]
[Pages 76628-76629]
[FR Doc No: 2022-27194]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3728]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Collection of
Conflict-of-Interest Information for Participation in Food and Drug
Administration Non-Employee Fellowship and Traineeship Programs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by January 17, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0882. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Collection of Conflict-of-Interest Information for Participation in
Food and Drug Administration Non-Employee Fellowship and Traineeship
Programs

OMB Control Number 0910-0882--Extension

    Section 742(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379l(b)) allows FDA to conduct and support intramural training
programs through fellowship and traineeship programs. Prospective
participants in these programs must complete financial disclosure forms
to determine if there is a conflict of interest that would preclude
participation. These new forms provide FDA with information about
financial investments and relationships from non-employee scientists
who participate in FDA fellowship and traineeship programs.
Participants in FDA fellowship and traineeship programs will be asked
for certain information about financial interests and current
relationships: (1) description of the financial interest; (2) the type
of financial interest (e.g., stocks, bonds, stock options); (3) if the
financial interest is an employee benefit from prior employment; (4)
value of financial interest; (5) who owns the financial interest (e.g.,
self, spouse, minor children); (6) employment relationship with an FDA
significantly regulated organization (SRO); and (7) service as a
consultant to an FDA SRO, and/or proprietary interest(s) in one of more
product(s) regulated by FDA, including a patent, trademark, copyright,
or licensing agreement. The purpose of the financial information is for
FDA to determine if there is a conflict of interest between the
Fellow's or Trainee's financial and relationship interests and their
activities at FDA. The collection of information is mandatory to
participate in FDA's fellowship and traineeship programs.
    In the Federal Register of July 7, 2022 (87 FR 40537), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Oak Ridge Institute for Science              500               1             500               1             500
 and Education Fellowship.......
Traineeship Program.............             500               1             500               1             500
Reagan Udall Fellowship at FDA..              50               1              50               1              50
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,050
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: December 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27194 Filed 12-14-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 229 (Wednesday, November 28, 2012)]
[Rules and Regulations]
[Pages 70885-70886]
[FR Doc No: 2012-28817]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 77, No. 229 / Wednesday, November 28, 2012 /
Rules and Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2000-N-0011]

Uniform Compliance Date for Food Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is establishing
January 1, 2016, as the uniform compliance date for food labeling
regulations that are issued between January 1, 2013, and December 31,
2014. We periodically announce uniform compliance dates for new food
labeling requirements to minimize the economic impact of label changes.
On December 15, 2010, we established January 1, 2014, as the uniform
compliance date for food labeling regulations issued between January 1,
2011, and December 31, 2012.

DATES: This rule is effective November 28, 2012. Submit electronic or
written comments by January 28, 2013.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2000-
N-0011, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2000-N-0011 for this rulemaking. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul L. Ferrari, Center for Food
Safety and Applied Nutrition (HFS-24), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA periodically issues regulations requiring changes in the
labeling of food. If the effective dates of these labeling changes were
not coordinated, the cumulative economic impact on the food industry of
having to respond separately to each change would be substantial.
Therefore, we periodically have announced uniform compliance dates for
new food labeling requirements (see, e.g., the Federal Register of
October 19, 1984 (49 FR 41019); December 24, 1996 (61 FR 67710);
December 27, 1996 (61 FR 68145); December 23, 1998 (63 FR 71015);
November 20, 2000 (65 FR 69666); December 31, 2002 (67 FR 79851);
December 21, 2006 (71 FR 76599); December 8, 2008 (73 FR 74349); and
December 15, 2010 (75 FR 78155). Use of a uniform compliance date
provides for an orderly and economical industry adjustment to new
labeling requirements by allowing sufficient lead time to plan for the
use of existing label inventories and the development of new labeling
materials. This policy serves consumers' interests as well because the
cost of multiple short-term label revisions that would otherwise occur
would likely be passed on to consumers in the form of higher prices.
    We have determined under 21 CFR 25.30(k) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
    This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). We believe that this final rule is not a significant
regulatory action under Executive Order 12866.
    The establishment of a uniform compliance date does not in itself
lead to costs or benefits. We will assess the costs and benefits of the
uniform compliance date in the regulatory impact analyses of the
labeling rules that take effect at that date.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant economic impact
of a rule on small entities. Because the final rule does not impose
compliance costs on small entities, FDA certifies that the final rule
will not have a significant economic impact on a substantial number of
small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000

or more (adjusted annually for inflation) in any one year.'' The
current threshold after adjustment for inflation is $139 million, using
the most current (2011) Implicit Price Deflator for the Gross Domestic
Product. We do not expect this final rule to result in any 1-year
expenditure that would meet or exceed this amount.
    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we have concluded that the
rule does not contain policies that have federalism implications as
defined in the Executive Order and, consequently, a federalism summary
impact statement is not required.
    This action is not intended to change existing requirements for
compliance dates contained in final rules published before January 1,
2013. Therefore, all final rules published by FDA in the Federal
Register before January 1, 2013, will still go into effect on the date
stated in the respective final rule.
    We generally encourage industry to comply with new labeling
regulations as quickly as feasible, however. Thus, when industry
members voluntarily change their labels, it is appropriate that they
incorporate any new requirements that have been published as final
regulations up to that time.
    In rulemaking that began with publication of a proposed rule on
April 15, 1996 (61 FR 16422), and ended with a final rule on December
24, 1996, we provided notice and an opportunity for comment on the
practice of establishing uniform compliance dates by issuance of a
final rule announcing the date. Receiving no comments objecting to this
practice, we find any further rulemaking unnecessary for establishment
of the uniform compliance date. Nonetheless, under 21 CFR 10.40(e)(1),
we are providing an opportunity for comment on whether this uniform
compliance date should be modified or revoked.
    The new uniform compliance date will apply only to final FDA food
labeling regulations that require changes in the labeling of food
products and that publish after January 1, 2013, and before December
31, 2014. Those regulations will specifically identify January 1, 2016,
as their compliance date. All food products subject to the January 1,
2016, compliance date must comply with the appropriate regulations when
initially introduced into interstate commerce on or after January 1,
2016. If any food labeling regulation involves special circumstances
that justify a compliance date other than January 1, 2016, we will
determine for that regulation an appropriate compliance date, which
will be specified when the final regulation is published.

II. Comments

    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: November 20, 2012.
 Leslie Kux,
 Assistant Commissioner for Policy.
[FR Doc. 2012-28817 Filed 11-27-12; 8:45 am]
BILLING CODE 4160-01-P


   Review Report for Corn, Steep Liquor (CASRN 66071-94-1) Partial Exemption

                                  October 2014

                      The Corn Refiners Association (CRA)
                   Docket Identifier:  EPA-HQ-OPPT-2014-0347
Summary of Decision:  The U.S. Environmental Protection Agency (hereinafter "EPA" or the "Agency") has determined that there is a low current interest in the processing and use information collected under the Chemical Data Reporting (CDR) rule (see 40 CFR Part 711) for Corn, steep liquor (CASRN 66071-94-1).  This determination is based on the totality of information on the chemical substance, including an evaluation of the considerations listed in 40 CFR 7l1.6(b)(2)(ii): 1) Consideration A: Current CDR information suggests that at least one site would have a production volume sufficient to trigger the need to report processing and use information for the 2016 CDR (25,000 pound threshold); 2) Consideration B: Based on the prior assessment letter by EPA's High Production Volume (HPV) Challenge Program and EPA's Office of Pesticide Program's (OPP) Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) minimal risk tolerance exemption under 40 CFR 180.950(b) for use as an inert ingredient in animal feed items, and confirmed by FDA's listing of Corn, steep liquor under 21 CFR 73.275 (also known as EAF Document 3073) as allowed in the color additive in dried algae meal used in chicken feed, EPA considers Corn, steep liquor to have a low hazard for human health and the environment.  For environmental fate, EPA determined that Corn, steep liquor has a potential to biodegrade, will not persist in the environment, and has a low potential for bioconcentration or bioaccumulation in aquatic organisms; 3) Consideration C: EPA is not aware of any currently existing unmet information needs for CDR processing and use information for this chemical substance; 4) Consideration D: EPA determined that, although the petitioner did not provide evidence that complementary risk screening information is available for Corn, steep liquor in its discussion under Consideration D, EPA's determination under the HPV Challenge Program that Corn, steep liquor has a low hazard concern and under OPP that Corn, steep liquor is of minimal risk for use in pesticides provide evidence of risk screening determinations in the United States for Corn, steep liquor; 5) Consideration E:  Comparable processing and use information is available in the European Chemical Agency's (ECHA's) database, and although it is for use of products in Europe and not the United States, it provides an indication of uses that may occur in the United States; and 6) Consideration F: EPA is unaware of any specific actions that have already taken by other agencies or authorities to manage risks relating to this substance.

A direct final rule to add Corn, steep liquor, to the list of chemical substances partially exempt from reporting CDR processing and use information in 40 CFR 711.6(2)(b)(iv) will be published in the Federal Register.  The final listing is pending, based on possible adverse responses to the Federal Register notice. If the level of interest in the CDR processing and use information for this chemical substance were to change after final listing, EPA may reevaluate the listing and pursue amendment of the listing as appropriate.

Persons submitting information in accordance with the CDR rule can still report processing and use information even if a chemical substance is partially exempt, so that their chemical substances may be considered for safer substitute analyses.

Background:  EPA received a petition from the Corn Refiners Association (CRA) (hereinafter the "petitioner"), requesting that Corn, steep liquor be added to the 40 CFR 711.6(b)(2)(iv) list of specific chemical substances that are exempt from the reporting requirements of 40 CFR 711.15(b)(4) (i.e., exempt from requirements to report industrial processing and use and commercial/consumer use information).  The chemical substances already included on this "partial exemption" list are substances for which EPA has previously determined that there is a low current interest in the CDR processing and use information.  However, as stated in the preamble to the Inventory Update Reporting Amendments (IURA) rule promulgated on January 7, 2003, "...the need for processing and use information under IURA changes over time.  The inclusion of a chemical substance under this partial exemption is not based on the potential risks of a chemical.  This partial exemption is solely intended to provide a tool to assist the Agency in better managing the collection of processing and use information..." and is also "...based on the Agency's current assessment of the need for collecting IURA processing and use information."   Additionally, the preamble states, "[i]n determining whether there is low current interest in IUR processing and use information related to a specific chemical substance, EPA will look to the specific circumstances surrounding the chemical in question, and may use one or more of the considerations identified below, and/or considerations not identified below, to make an informed decision." The considerations used by EPA in reviewing this petition and an analysis of how those considerations relate to Corn, steep liquor are set forth below.

Discussion:  EPA considered information submitted with the petition, as well as other information including, but not limited to:  whether the petitioned chemical substance is listed on the Emergency Planning and Community Right to Know Act (EPCRA), Section 313 list of Toxic Chemicals and thus is reportable to the Toxics Release Inventory (TRI); 2012 CDR submissions for the chemical substance; evaluations available through the EPA's Integrated Risk Information System (IRIS), the International Agency for Research on Cancer (IARC), the Organisation for Economic Co-operation and Development's (OECD)'s HPV Screening Information Data Set (SIDS) program, or the EPA's HPV Challenge Program; whether the substance is subject to other regulatory programs administered by EPA or other federal agencies; and other information researched by EPA to supplement the petition.

The petitioner provided information concerning Corn, steep liquor from a variety of sources and linked it to specific considerations cited in 40 CFR 711.6(b)(2)(ii).

Consideration A:  Whether the chemical qualifies or has qualified in past IUR collections for the reporting of the information described in 40 CFR 711.15(b)(4).

The petitioner provided information to show that that Corn, steep liquor was reported for the 2012 CDR.  EPA reviewed the 2012 CDR data for Corn, steep liquor and found that 10 sites reported domestically manufacturing and/or importing Corn, steep liquor with a nationally aggregated production volume of 250 million to 500 million pounds in 2011.

EPA has concluded that at least one manufacturing site would likely have a production volume sufficient to trigger the need to report processing and use information for the 2016 CDR (25,000 pound threshold).  Thus, EPA concludes that the other considerations are ripe for evaluation.

Consideration B:  The chemical substance's chemical and physical properties or potential for persistence, bioaccumulation, health effects, or environmental effects (considered independently or together).

The petitioner provided information on Corn, steep liquor from the CRA's 2008 Revised Assessment Plan for Corn, steep Liquor, which was provided to EPA's HPV Challenge Program along with the International Uniform Chemical Information Database (IUCLID) data set. In addition, the petitioner provided the Technical Evaluation Report, Compiled by the Technical Services Branch for the U.S. Department of Agriculture (USDA) National Organic Program. The submitted information are not adequate for assessing Corn, steep liquor's potential hazards to the environment.
In 2008, EPA reviewed CRA's 2006 Assessment Plan for Corn, steep liquor submitted for the HPV Challenge Program and concluded that there is low concern for hazard for both ecotoxicity and human health endpoints. Corn, steep liquor is listed under 40 CFR §180.950(b) as having a tolerance exemption as a minimal risk for use in animal feed items as either an inert or an active ingredient in pesticide chemical formulations, including antimicrobial pesticide chemicals In concluding that the tolerance is safe, EPA conducts a human health risk assessment and ecological effects assessment and makes a determination of safety for the pesticide chemical residue.

EPA also considered other sources of information to confirm its decisions on human health, environmental toxicity, and environmental fate including FDA's listing of Corn, steep liquor under 21 CFR 73.275 (also known as EAF Document 3073) as allowed in the color additive in dried algae meal used in chicken feed in accordance with prescribed conditions and the European Union's (EU's) Registration, Evaluation, and Authorization of Chemicals (REACH) registration.

Human Health Effects.  Prior evaluation of Corn, steep liquor by EPA's HPV Challenge Program determined a low concern for human health hazards because the sponsored substance is about one-half water and the majority of the rest is lactic acid, protein and other nutritive substances. While the crude protein component could contain low molecular weight proteins that could be antigenic if isolated, these are not expected to pose a hazard as components of such an aqueous mixture.

Environmental Effects. As noted above, under the HPV Challenge Program, EPA concluded there is "a low concern for hazard" for ecotoxicity as "the sponsored substance is about one-half water and the majority of the rest is lactic acid, protein and other nutritive substances." This conclusion supports the petitioner's assertion of low toxicity to aquatic organisms. There is a concern for eutrophication from multiple releases of Corn, steep liquor to freshwater over time.  However, based on EPA's conclusion under the HPV Challenge Program and the FIFRA inert ingredient tolerance exemption, EPA accepts that Corn, steep liquor would be considered to have a low hazard to the environment.
Environmental Fate. Corn, steep liquor consists of water and water soluble nutrients.  It is expected to partition to water when released to the environment. No measured biodegradation, bioconcentration, or bioaccumulation data were submitted by the petitioner, but EPA found, in data submitted under the EU REACH registration, an OECD test guideline 310 Ready Biodegradability test summary.  In the 28-day ready biodegradability test, > 80% biodegradation occurred within the first 7 days.  Therefore, the substance is considered to be readily biodegradable and not expected to persist in the aquatic or soil environment.  The petitioner asserted that Corn, steep liquor is not expected to bioaccumulate based on its composition of water soluble components derived from soaking corn in water.  EPA determined that the HPV Challenge Program submission adequately addressed the physical-chemical and environmental fate endpoints.
EPA believes that the review under the HPV Challenge Program and OPP tolerance exemption provide sufficient evidence to address human health, environmental toxicity, and environmental fate concerns for Corn, steep liquor. EPA accepts that the OPPT comments document, along with the Ready Biodegradability test summary, indicating that Corn, steep liquor is readily biodegradable, will not persist in the environment, and has a low potential for bioconcentration and bioaccumulation, are sufficient evidence to address environmental fate concerns. Taken together, this information is sufficient to weigh in favor of partially exempting Corn, steep liquor from CDR reporting based on human health and environmental concerns covered under Consideration B.

Consideration C:  The information needs of EPA, other federal agencies, tribes, states, and local governments, as well as members of the public.

The petitioner stated that it was unaware of any unmet information needs of EPA, other federal agencies, tribes, states, local governments, or members of the public in light of FDA regulatory clearances available for Corn, steep liquor in food applications and the extensive data published on the ECHA website.  The petitioner also noted that Corn, steep liquor has not been the subject of information collection requirement by EPA under the Toxic Substances Control Act (TSCA) (other than CDR), the Interagency Testing Committee (ITC), or the Agency for Toxic Substances and Disease Registry (ATSDR). The petitioner asserts that there is sufficient information available, and there have been no previous information requests.

EPA is not aware of any currently existing unmet information needs respecting the processing and use of Corn, steep liquor and agrees that processing and use information for this chemical is otherwise available to government agencies and the public on the ECHA website. Although the uses in Europe may not be exactly the same as the uses in the United States, EPA believes they can provide an indication of potential uses on which to base further analysis, should the chemical substance be of interest (for a detailed summary of specific uses see Consideration E). Overall, EPA regards Consideration C as weighing in favor of establishing a partial exemption for this chemical substance.

Consideration D:  The availability of other complementary risk screening information.

The petitioner included a table which provided the status of the petitioned substance under the REACH registration program, status under the voluntary EPA HPV Challenge Program, and status as a pesticide inert.  However, no discussion was provided linking the status to the availability of recent risk screening information.  Therefore, it is unclear how this table relates to Consideration D, the availability of other complementary risk screening information.  The fact that Corn, steep liquor is not exempt from REACH and is the subject of a full REACH registration is not sufficient information.  The petitioner indicated that Corn, steep liquor has an HPV status of 4, indicating that a company wished to sponsor it; however, the petitioner neglected to mention the more relevant point that not only had the substance been sponsored, but robust summaries and a test plan had been submitted to EPA, and the Agency had concluded that there is low concern for hazard for both ecotoxicity and human health endpoints. Additionally, the listing of Corn, steep liquor as a 4B pesticide inert is outdated.  Under 40 CFR 180.950(b), animal feed items have tolerance exemptions as minimal risk active or inert ingredients in pesticides.  As the petitioner indicated, the primary use of Corn, steep liquor is as a nutrient supplement in animal feed.  This is based on a determination that safety concerns would have been addressed during the long history of safe use of animals consuming the feed items and then producing products that are in turn consumed by humans (67 FR 1928, January 15, 2002).  FDA listed Corn, steep liquor under 21 CFR 73.275 (also known as EAF Document 3073) as allowed in the color additive in dried algae meal used in chicken feed in accordance with prescribed conditions, with the same considerations as for the FIFRA minimal risk tolerance exemption.

EPA determined that the petition did not provide evidence that complementary risk screening information is available for Corn, steep liquor in its discussion under Consideration D.  However, EPA's determinations under the HPV Challenge Program that Corn, steep liquor has a low hazard concern, and under the Pesticides Program that Corn, steep liquor is of minimal risk for use in pesticides provide evidence of risk screening determinations in the United States for Corn, steep liquor. Overall, EPA concluded that the availability of information relevant to Consideration D weighs in favor of partially exempting Corn, steep liquor from CDR reporting.

Consideration E:  The availability of comparable processing and use information.

The petitioner stated that the processing and use of Corn, steep liquor is well characterized and asserted that TSCA-regulated exposures are comparable to, or less significant than, the food-use exposures associated with these substances, which have already been shown to be "safe". While it is true that Corn, steep liquor's predominant use in animal food is well characterized, this is not a use subject to TSCA.   Under Consideration B, the petitioner also noted that Corn, steep liquor is used in the chemical industry in the production of acetic acids, food acids and in fermentation, which would be uses subject to TSCA.  Under Consideration C, the petitioner referenced the extensive data available on the ECHA website.

The uses in the ECHA database are for the EU and indicate that Corn, steep liquor is used in Europe in fertilizers and products such as pH-regulators, flocculants, precipitants, and neutralization agents.  Data from the non-confidential 2012 CDR database identified the following industrial uses: non-pesticidal agricultural chemicals, fillers, functional fluids, intermediates, and processing aids.  The following consumer and commercial uses were also identified:  non-pesticidal agricultural products, anti-freeze and de-icing products.

On balance, EPA agrees that other recent processing and use information, available from ECHA is sufficiently comparable to CDR processing and use information to favor granting a partial reporting exemption for this chemical substance.  While the ECHA information may not be completely representative of use in the United States, EPA concluded in this case (in view of all relevant considerations) that the ECHA information is a reasonable surrogate indicator of possible United States processing and use.  EPA also recognizes that the ECHA database does not specify the amounts of Corn, steep liquor to each use.  But when considered in combination with the other substance-specific factors that weigh in favor of granting a partial reporting exemption (e.g., the evidence that the potential human health effects and/or environmental effects would be low) EPA does not regard the lack of use-by-use volume information as sufficient to affect the decision.

Consideration F: Whether the potential risks of the chemical substance are adequately managed by EPA or another agency or authority.

The petitioner generally indicated that the manufacturing and use of Corn, steep liquor primarily falls within the jurisdiction and authority of the FDA.  The petitioner also stated that EPA, the Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH), and the Consumer Product Safety Commission (CPSC) regulate the manufacture and use of Corn, steep liquor. However, the petitioner did not specifically identify which uses of Corn, steep liquor are regulated by the foregoing governmental bodies or regulations, except for the FDA regulation at 21 CFR 73.275, which allows Corn, steep liquor to be in dried algae meal that is used as a color additive in chicken feed.

Overall, although the petition included the general claim that this substance is already "controlled adequately under other regulatory regimes," it did not identify how any particular agency or authority was managing any particular risk relating to this substance, or how such risk management actions should bear on EPA's level of current interest in processing and use information.

As noted above, EPA has determined that Corn, steep liquor is a minimal risk active or inert pesticide ingredient.  EPA is unaware of any specific actions that have already taken by other agencies or authorities to manage risks relating to this substance.  However, given the evidence that the potential human health effects and/or environmental effects would be low, EPA does not therefore assume that this substance would likely be the subject of risk management actions in the future.  Thus, in this case, EPA believes this consideration weighs neither in favor of nor against adding the substance to the CDR partial exemption list.


[Federal Register Volume 87, Number 47 (Thursday, March 10, 2022)]
[Notices]
[Page 13790]
[FR Doc No: 2022-05038]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2019-0003]

Petition for Extension of Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on January 12, 2022, Canadian
National Railway Company (CN) petitioned the Federal Railroad
Administration (FRA) for an extension of a waiver of compliance from
certain provisions of the Federal railroad safety regulations contained
at 49 CFR 232.305, Single car air brake tests. The relevant FRA Docket
Number is FRA-2019-0003.
    Specifically, CN requests to extend relief from Sec.
232.305(b)(2), regarding the requirement to conduct a single car air
brake test (SCT) on a car when it is placed on a repair track for any
reason, and the car has not had a SCT in the previous 12 months. CN
explains that it seeks to continue using this relief for the in-train
wheelset replacement program in Fulton, KY, a purpose-built facility
that utilizes a drop table to safely and efficiently replace defective
wheelsets while keeping the train intact. The program identifies and
replaces wheelsets with minor defects falling between Association of
American Railroads standards and FRA requirements, which assists in
reducing the number of wheel, bearing, impact, and broken rail-caused
derailments, as well as associated injuries.
    CN states that it has complied with the requirements of FRA's
approval letter, dated June 14, 2019, and successfully changed out
4,454 wheels from the date of approval until December 23, 2021. CN
reports no injuries or accidents due to the operation of the facility.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted at http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Communications received by April 25, 2022 will be considered by FRA
before final action is taken. Comments received after that date will be
considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), the U.S. Department of Transportation (DOT)
solicits comments from the public to better inform its processes. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacy-notice for the privacy notice of
regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2022-05038 Filed 3-9-22; 8:45 am]
BILLING CODE 4910-06-P