[Federal Register Volume 86, Number 76 (Thursday, April 22, 2021)]
[Notices]
[Pages 21392-21393]
[FR Doc No: 2021-08305]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91587; File Nos. SR-DTC-2021-002; SR-FICC-2021-001; SR-
NSCC-2021-003]

Self-Regulatory Organizations; The Depository Trust Company;
Fixed Income Clearing Corporation; National Securities Clearing
Corporation; Order Approving Proposed Rule Changes To Revise the
Clearing Agency Investment Policy

April 16, 2021.
    On March 8, 2021, The Depository Trust Company (``DTC''), Fixed
Income Clearing Corporation (``FICC''), and National Securities
Clearing Corporation (``NSCC,'' each a ``Clearing Agency,'' and
collectively, the ``Clearing Agencies''), filed with the Securities and
Exchange Commission (``Commission'') proposed rule changes SR-DTC-2021-
002; SR-FICC-2021-001; SR-NSCC-2021-003, respectively, pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder.\2\ The proposed rule changes were published
for comment in the Federal Register on March 16, 2021,\3\ and the
Commission received no comment letters regarding the proposed rule
changes. For the reasons discussed below, the Commission is granting
approval of the proposed rule changes.\4\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release Nos. 91291 (March 10,
2021), 86 FR 14500 (March 16, 2021) (SR-DTC-2021-002) (``DTC Notice
of Filing''); 91292 (March 10, 2021), 86 FR 14503 (March 16, 2021)
(SR-FICC-2021-001) (``FICC Notice of Filing''); and 91293 (March 10,
2021), 86 FR 14506 (March 16, 2021) (SR-NSCC2021-003) (``NSCC Notice
of Filing'').
    \4\ Capitalized terms not defined herein are defined in the DTC
Rules, By-laws and Organization Certificate (``DTC Rules''), the
Rules & Procedures of NSCC (``NSCC Rules''), the Clearing Rules of
the Mortgage-Backed Securities Division of FICC (``MBSD Rules''), or
the Rulebook of the Government Securities Division of FICC (``GSD
Rules''), as applicable, available at http://dtcc.com/legal/rules-and-procedures.
---------------------------------------------------------------------------

I. Description of the Proposed Rule Changes

A. Background

    Each Clearing Agency has established a Clearing Agency Investment
Policy (``Investment Policy''),\5\ which governs the management,
custody, and investment of cash deposited to the DTC Participants Fund
and the respective NSCC and FICC Clearing Funds,\6\ the proprietary
liquid net assets (cash and cash equivalents) of the Clearing Agencies,
and other funds held by the Clearing Agencies pursuant to their
respective rules. The Investment Policy states that it would adhere to
a conservative investment philosophy that places the highest priority
on maximizing the liquidity and avoiding risk to the funds in the
custody of the Clearing Agencies.\7\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 79528 (December 12,
2016), 81 FR 91232 (December 16, 2016) (SR-DTC-2016-007; SR-FICC-
2016-005; SR-NSCC-2016-003) (``2016 Framework Order'').
    \6\ The DTC Participants Fund and the respective Clearing Funds
of NSCC and FICC are described further in DTC Rules, NSCC Rules,
MBSD Rules, GSD Rules, respectively. See DTC Rules, Rule 4
(Participants Fund and Participants Investment); NSCC Rules, Rule 4
(Clearing Fund); GSD Rules, Rule 4 (Clearing Fund and Loss
Allocation); MBSD Rules, Rule 4 (Clearing Fund and Loss Allocation).
    \7\ See 2016 Framework Order, 81 FR at 91233.
---------------------------------------------------------------------------

    The Investment Policy includes, generally, a glossary of key terms,
the roles and responsibilities of DTCC staff in administering the
Investment Policy, guiding principles for investments, sources of
investable funds, allowable investments of those funds, limitations on
such investments, authority required for those investments, and
authority required to exceed established investment limits.\8\ In
particular, the Investment Policy provides that allowable investments
include bank deposits, reverse repurchase agreements, direct
obligations of the U.S. government, money market mutual funds, high-
grade corporate debt, and hedge transactions.\9\
---------------------------------------------------------------------------

    \8\ See 2016 Framework Order, 81 FR at 91232-33.
    \9\ See DTC Notice of Filing, 86 FR at 14501; FICC Notice of
Filing, 86 FR at 14504; NSCC Notice of Filing, 86 FR at 14506.
---------------------------------------------------------------------------

B. Settling Bank Deposit Investment Limits

    The Investment Policy sets forth the investment limits applicable
to bank deposit investments. Currently, bank deposit investment limits
are determined based on the bank counterparty's external credit
rating.\10\
---------------------------------------------------------------------------

    \10\ See DTC Notice of Filing, 86 FR at 14501; FICC Notice of
Filing, 86 FR at 14504; NSCC Notice of Filing, 86 FR at 14507.
---------------------------------------------------------------------------

    The Clearing Agencies propose to revise the methodology for setting
investment limits on bank deposits with a particular counterparty by
including a consideration of the size of the bank counterparty,
measured as the total shareholders' equity capital, in this
calculation. Under the proposed methodology, an investment limit for a
bank deposit counterparty would continue to be based on the
counterparty's credit rating, but would be the lower of (1) a
percentage of its total shareholders' equity capital, and (2) the
applicable dollar value that is currently in the Investment Policy. The
proposed approach would take into account the size of a counterparty in
setting investment limits rather than applying the same investment
limits to each counterparty with the same credit rating without regard
to the entity's size.

C. Description of Investable Funds of GSD

    The Clearing Agencies also propose to amend their respective
Investment Policy to revise the description of investable funds of GSD.
The current term used in the Investment Policy, ``GSD Forward Margin,''
would be changed to ``GSD Forward Mark Adjustment Payment.'' The GSD
Rules define these funds as ``Forward Mark Adjustment Payment,'' \11\
and the Clearing Agencies represent that the proposed change is to
harmonize the terms used in the Investment Policy with the GSD Rules,
and prevent any confusion about which funds are investable by the
Clearing Agencies pursuant to the Investment Policy.\12\
---------------------------------------------------------------------------

    \11\ See GSD Rules, Rule 1 (Definitions).
    \12\ See DTC Notice of Filing, 86 FR at 14501; FICC Notice of
Filing, 86 FR at 14504; NSCC Notice of Filing, 86 FR at 14507.
---------------------------------------------------------------------------

II. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act \13\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if it
finds that such proposed rule change is consistent with the
requirements of the Act and rules and regulations thereunder applicable
to such organization. After careful consideration, the Commission finds
that the proposed rule changes are consistent with the requirements of
the Act and the rules and regulations thereunder applicable to the
Clearing Agencies. In particular, the Commission finds that the
proposed rule changes are consistent with Section 17A(b)(3)(F) \14\ of
the Act and Rule 17Ad-22(e)(16) thereunder.\15\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(2)(C).
    \14\ 15 U.S.C. 78q-1(b)(3)(F).
    \15\ 17 CFR 240.17Ad-22(e)(16).
---------------------------------------------------------------------------

A. Consistency With Section 17A(b)(3)(F) of the Act

    Section 17A(b)(3)(F) of the Act requires, in part, that the rules
of a clearing agency be designed to assure the safeguarding of
securities and funds which are in the custody or control of the
clearing agency or for which it is responsible.\16\
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    The proposed changes would require the Clearing Agencies to
consider the counterparty shareholders' equity capital in limiting
investments for bank deposit investments. By considering not only the
credit rating of a bank

counterparty, but also the size of a bank counterparty in setting its
bank deposit investment limit, the proposed change would help the
Clearing Agencies to cap their exposure to smaller counterparties,
measured by their shareholders' equity capital. In turn, the proposed
changes should help the Clearing Agencies to continue to adhere to the
prudent and conservative investment philosophy that places the highest
priority on maximizing liquidity and risk avoidance.
    In addition, the proposed changes would align the terminology used
in the Investment Policy with the terminology used in the GSD Rules to
clarify the investable funds that are subject to the Investment Policy.
By eliminating inconsistent use of terminology, the proposed changes
should help to improve the effectiveness of the Investment Policy.
    Therefore, for the reasons stated above, the Commission believes
that the proposed rule changes are designed to assure the safeguarding
of securities and funds in the custody and control of the Clearing
Agencies consistent with the requirements of Section 17A(b)(3)(F) of
the Act.\17\
---------------------------------------------------------------------------

    \17\ Id.
---------------------------------------------------------------------------

B. Consistency With Rule 17Ad-22(e)(16) Under the Act

    Rule 17Ad-22(e)(16) under the Act requires the Clearing Agencies to
establish, implement, maintain and enforce written policies and
procedures reasonably designed to safeguard the Clearing Agencies' own
and their participants' assets, minimize the risk of loss and delay in
access to these assets, and invest such assets in instruments with
minimal credit, market, and liquidity risks.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 240.17Ad-22(e)(16).
---------------------------------------------------------------------------

    As stated above, the proposed changes would require the Clearing
Agencies to consider the counterparty shareholders' equity capital in
limiting investment for bank deposit investments, and align the
description of investable funds of GSD in the Investment Policy with
the description of these funds in the GSD Rules to clarify the funds
that are subject to the Investment Policy. By limiting the Clearing
Agencies' exposure to smaller counterparties and removing any confusion
about which funds are subject to the Investment Policy, the proposed
changes are designed to strengthen the risk management objectives, and
improve the clarity, of the Investment Policy.
    Accordingly, the Commission believes that the proposed changes are
reasonably designed to help safeguard the Clearing Agencies' own and
their participants' assets, minimize the risk of loss and delay in
access to these assets, and invest such assets in instruments with
minimal credit, market, and liquidity risks, and is therefore
consistent with Rule 17Ad-22(e)(16) under the Act.\19\
---------------------------------------------------------------------------

    \19\ Id.
---------------------------------------------------------------------------

III. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed rule changes are consistent with the requirements of the Act,
and in particular, with the requirements of Section 17A of the Act,\20\
and the rules and regulations promulgated thereunder.
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\21\ that proposed rule changes SR-DTC-2021-002, SR-FICC-2021-001,
SR-NSCC-2021-003, be, and they hereby are, Approved.\22\
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78s(b)(2).
    \22\ In approving the proposed rule changes, the Commission
considered the proposals' impact on efficiency, competition, and
capital formation. See 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).

J. Lynn Taylor,
Assistant Secretary.
[FR Doc. 2021-08305 Filed 4-21-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 87 (Thursday, May 5, 2022)]
[Rules and Regulations]
[Pages 26691-26694]
[FR Doc No: 2022-09622]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0545; FRL-9761-01-OCSPP]

Cell Walls of Saccharomyces Cerevisiae; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of cell walls of Saccharomyces cerevisiae
(also known as yeast cell walls or YCWs) when used as a carrier inert
ingredient in pesticide formulations in pre-harvest applications to
crops. SciReg, Inc., on behalf of Eden Research, submitted a petition
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of cell walls of Saccharomyces cerevisiae on food or feed
commodities when used in accordance with this exemption.

DATES: This regulation is effective May 5, 2022. Objections and
requests for hearings must be received on or before July 5, 2022, 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-2018-0545, is available at
https://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 and OPP Docket is<PHONE_NUMBER>. Due to the public health
concerns related to COVID-19, the EPA Docket Center (EPA/DC) and
Reading Room is open to visitors by

appointment only. For the latest status information on EPA/DC services
and access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
https://www.ecfr.gov/current/title-40.

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2018-0545 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 5, 2022. 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-2018-0545, by one of
the following methods.
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of October 18, 2018 (83 FR 52787), EPA
issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a,
announcing the receipt of a pesticide petition (PP IN-11175) filed by
SciReg, Inc. (12733 Director's Loop, Woodbridge, VA 22192), on behalf
of Eden Research. The petition requested that 40 CFR 180.920 be amended
by establishing an exemption from the requirement of a tolerance for
residues of cell walls of Saccharomyces cerevisiae (also known as yeast
cell walls or YCWs) when used as a carrier inert ingredient in
pesticide formulations applied pre-harvest to crops. That document
included a summary of the petition prepared by the petitioner and
solicited comments on the petitioner's request. The Agency did not
receive any public comments.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA
defines ``safe'' to mean that EPA has determined 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 it 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 an exemption 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.''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no harm to human health. In order to determine
the risks from aggregate exposure to pesticide inert ingredients, the
Agency considers the toxicity of the inert in conjunction with possible
exposure to residues of the inert ingredient through food, drinking
water, and through other exposures that occur as a result of pesticide
use in residential settings. If EPA is able to determine that a
tolerance is not necessary to ensure that there is a reasonable
certainty that no harm will result from aggregate exposure to the inert
ingredient, an exemption from the requirement of a tolerance may be
established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action and considered its

validity, completeness and reliability and the relationship of this
information to human risk. EPA has also considered available
information concerning the variability of the sensitivities of major
identifiable subgroups of consumers, including infants and children.
EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure to YCWs, including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with YCWs follows.

A. Toxicological Profile

    YCWs are obtained by hydrolyzing intact yeast (Saccharomyces
cerevisiae) cells. Given the long history of safe dietary exposure to
strains of S. cerevisiae through their use in food, beverages, and
nutritional supplements, YCWs are expected to be non-toxic. Although no
toxicity information is available for YCWs, data from the major
chemical components of YCWs ([beta]-glucan and mannan) are used to
assess the safety of YCWs.
    The acute oral toxicity of [beta]-glucan is low, with an
LD50 >2,000 mg/kg. The repeated-dose toxicity for the major
components of YCWs is low. No adverse effects were observed in
subchronic studies in mice or rats or in a screening reproductive
toxicity study in rats with [beta]-glucan.
    No oral chronic or carcinogenicity studies are available for YCWs
or its components. However, there is low concern for genotoxicity or
mutagenicity, based on negative results in mammalian and bacterial
genotoxicity tests with [beta]-glucan and mannan. No evidence of
neurotoxicity or immunotoxicity is seen in the available studies.

B. Toxicological Points of Departure/Levels of Concern

    No toxicological endpoint of concern for YCWs has been identified
in the database.

C. Exposure Assessment

    1. Dietary exposure. Dietary exposure (food and drinking water) may
occur from the current pesticidal uses of cell walls of Saccharomyces
cerevisiae strain LAS117 as well as the proposed pre-harvest use of
YCWs in crops (e.g., eating foods treated with pesticide formulations
containing YCWs, and drinking water exposures). Dietary exposure may
also occur from non-pesticidal exposure (e.g. YCW dietary supplements).
However, no endpoint of concern was identified. Therefore, a
quantitative acute or chronic dietary exposure assessment is not
necessary for YCWs.
    2. Residential exposure. The current pesticidal uses of cell walls
of Saccharomyces cerevisiae strain LAS117 as well as the proposed pre-
harvest use of YCWs in crops are not anticipated to result in
residential exposure. Residential exposure may occur from non-
pesticidal uses (e.g., skin care products). However, no toxicological
endpoint of concern was identified. Therefore, a quantitative
assessment for residential exposure was not performed.
    3. Cumulative effects from substances with a common mechanism of
toxicity. Unlike pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to YCWs and any other
substances, and YCWs do not appear to produce a toxic metabolite
produced by other substances. For the purposes of this action,
therefore, EPA has assumed that YCWs do not have a common mechanism of
toxicity with other substances.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database unless EPA concludes that
a different margin of safety will be safe for infants and children. As
part of its qualitative assessment, the Agency did not use safety
factors for assessing risk to YCWs, and no additional safety factor is
needed for assessing risk to infants and children. Based on the low
toxicity in the available studies, EPA has concluded that there are no
toxicological endpoints of concern for the U.S. population, including
infants and children.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on YCWs, EPA
has determined that there is a reasonable certainty that no harm to the
general population or any population subgroup, including infants and
children, will result from aggregate exposure to YCW residues.
Therefore, the establishment of an exemption from the requirement of a
tolerance under 40 CFR 180.920 for residues of YCWs when used as a
carrier inert ingredient in pesticide formulations in pre-harvest
applications to crops is safe under FFDCA section 408.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
YCWs in or on any food commodities.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). Codex 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.
    The Codex has not established a MRL for YCWs.

VI. Conclusion

    Taking into consideration all available information on YCWs, EPA
has determined that there is a reasonable certainty that no harm to the
general population or any population subgroup, including infants and
children, will result from aggregate exposure to YCW residues.
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for YCWs when used as an inert
ingredient (carrier) in pesticide formulations.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of 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). 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
exemption 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).

VIII. 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: April 29, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.920, amend Table 1 to 180.920 by adding in alphabetical
order an entry for ``Cell Walls of Saccharomyces cerevisiae'' to read
as follows:

Sec.  180.920   Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.

* * * * *

                           Table 1 to 180.920
------------------------------------------------------------------------
           Inert ingredients              Limits            Uses
------------------------------------------------------------------------

                                * * * * *
Cell Walls of Saccharomyces cerevisiae  .........  Carrier.

                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2022-09622 Filed 5-4-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 249 (Wednesday, December 28, 2011)]
[Notices]
[Pages 81510-81511]
[FR Doc No: 2011-33232]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0652]

Draft Guidance for Industry and Food and Drug Administration
Staff; the 510(k) Program: Evaluating Substantial Equivalence in
Premarket Notifications [510(k)]; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Draft Guidance for
Industry and Food and Drug Administration Staff; The 510(k) Program:
Evaluating Substantial Equivalence in Premarket Notifications
[510(k)].'' FDA developed this draft guidance document to provide a
contemporary perspective on how FDA reviews premarket notification
(510(k)) submissions as well as on the Special and Abbreviated 510(k)
programs. This guidance addresses the major aspects of the 510(k)
decision-making process and updates FDA's policies with respect to the
Special and Abbreviated 510(k) programs. This draft guidance is not
final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 26, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Draft Guidance for Industry and Food and
Drug Administration Staff; The 510(k) Program: Evaluating Substantial
Equivalence in Premarket Notifications [510(k)]'' to the Division of
Small Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002 or
to the Office of Communication, Outreach and Development (HFM-40),
Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist that office in processing your
request, or fax your request to<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
Jonette Foy, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1676, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>;
or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION

I. Background

    This draft guidance serves to update FDA's perspective on the
Agency's approach to the 510(k) program, which began in 1976. Since
that time, FDA has periodically published guidance that described its
approach and any changes therein, to the 510(k) program. On June 30,
1986, FDA published a Blue Book Memorandum titled ``Guidance on the
CDRH Premarket Notification Review Program, 510(k) Memorandum
K86-3,'' a document which discussed general points regarding
the process of determining substantial equivalence between a new device
and a predicate device. On March 20, 1998, FDA published another
guidance document titled ``The New 510(k) Paradigm--Alternate
Approaches to Demonstrating Substantial Equivalence in Premarket
Notifications.'' This guidance introduced two new 510(k) programs--the
Special 510(k) and the Abbreviated 510(k)--as optional approaches
available to device manufacturers. This guidance also renamed the
original 510(k) program that had been in place since 1976 to the
``Traditional 510(k).'' Traditional, Special, and Abbreviated 510(k)s
differ with respect to the scope and content of information that are
included within the submission. The Special 510(k) is an option for a
manufacturer who has made certain changes to a medical device that was
previously found substantially equivalent. With this option, the
manufacturer relies on conformance with design controls under the
Quality System Regulation (21 CFR 820.30) to support substantial
equivalence. The Abbreviated 510(k) is an option for manufacturers who
rely on guidance documents, special controls, and/or recognized
consensus standards to support substantial equivalence. These alternate
approaches were intended to streamline FDA's review process and
simplify for manufacturers the preparation of a 510(k) that was
eligible for these programs. It is noted that the 1986 guidance was
issued as final guidance prior to the February 27, 1997, implementation
of FDA's Good Guidance Practices (GGPs). Neither guidance has been
updated since its initial publication. Upon its issuance as a final
guidance document, this new guidance will replace both of those
guidances.
    In recent years, concerns have been raised both within and outside
of FDA about whether the 510(k) program optimally achieves its intended
goals. In September 2009, FDA's Center for Devices and Radiological
Health (CDRH) convened an internal 510(k) Working Group to conduct a
comprehensive assessment of the 510(k) process. The 510(k) Working
Group evaluated the 510(k) program with the goal of strengthening the
program and improving the predictability, consistency, and transparency
of the Agency's decision-making process. On February 18, 2010, the
510(k) Working Group held a public meeting to solicit comments from the
public regarding the strengths and challenges associated with the
510(k) program. In August 2010, CDRH published two documents in
consideration of the comments made at the public meeting and the
Agency's preliminary assessment of the program. These documents are
titled ``CDRH Preliminary Internal Evaluations--Volume I: 510(k)
Working Group Preliminary Report and Recommendations'' and ``CDRH
Preliminary Internal Evaluations--Volume II: Task Force on the
Utilization of Science in Regulatory Decision Making Preliminary Report
and

Recommendations.'' In January 2011, CDRH published the ``Plan of Action
for Implementation of 510(k) and Science Recommendations,'' denoting as
one of the action items to update the 1998 510(k) Paradigm Guidance.
    FDA recognizes and supports efforts for global convergence of
regulatory systems, and in particular, through its participation in the
Global Harmonization Task Force which published the ``Summary Technical
Documentation for Demonstrating Conformity to the Essential Principles
of Safety and Performance of Medical Devices (STED)'' on February 21,
2008. The Agency has specifically considered the STED principles in the
FDA Guidance titled ``Guidance for Industry and FDA Staff: Format for
Traditional and Abbreviated 510(k)s'' and has also incorporated those
principles in this guidance as appropriate. FDA is specifically
interested in seeking comment with respect to how these principles may
be further applied in this guidance document and to 510(k) submissions
and review generally.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the 510(k)
decision-making process and policies with respect to the 510(k)
program. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternative approach
may be used if such approach satisfies the requirements of the
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov or from CBER
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm.
    To receive ``Draft Guidance for Industry and Food and Drug
Administration Staff; The 510(k) Program: Evaluating Substantial
Equivalence in Premarket Notifications [510(k)],'' you may either send
an email request to<EMAIL_ADDRESS>to receive an electronic copy of
the document or send a fax request to<PHONE_NUMBER> to receive a hard
copy. Please use the document number 1766 to identify the guidance you
are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to currently approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 820 have been approved under
OMB control number 0910-0073; the collections of information in 21 CFR
part 812 have been approved under OMB control number 0910-0078; the
collections of information in 21 CFR 807 subpart E have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 56.115 have been approved under OMB control number 0910-
0130; the collections of information found in 21 CFR part 814 have been
approved under OMB control number 0910-0231; the collections of
information in 21 CFR part 803 have been approved under OMB control
number 0910-0437; and the collections of information in 21 CFR part 801
have been approved under OMB control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.

    Dated: December 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33232 Filed 12-27-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 87, Number 40 (Tuesday, March 1, 2022)]
[Notices]
[Pages 11427-11429]
[FR Doc No: 2022-04230]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2021-0749; FRL-9181-01-OCSP]

Agency Information Collection Activities; Proposed Renewal of an
Existing Collection and Request for Comment; Foreign Purchaser
Acknowledgement Statement

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this
document announces the availability of and solicits public comment on
an Information Collection Request (ICR) that EPA is planning to submit
to the Office of Management and Budget (OMB). The ICR, entitled:
``Foreign Purchaser Acknowledgement Statement'' and identified by EPA
ICR No. 0161.16 and OMB Control No. 2070-0027, represents the renewal
of an existing ICR that is scheduled to expire on December 31, 2022.
Before submitting the ICR to OMB for review and approval under the PRA,
EPA is soliciting comments on specific aspects of the information
collection that is summarized in this document. The ICR and
accompanying material are available in the docket for public review and
comment.

DATES: Comments must be received on or before May 2, 2022.

ADDRESSES: Submit your comments, identified by docket identification
(ID)

number EPA-HQ-OPP-2021-0749, though the Federal eRulemaking Portal at
https://www.regulations.gov. Follow the online instructions for
submitting comments. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is opened to visitors by
appointment only. For the latest status information on EPA/DC and
docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For general information contact:
Carolyn Siu, Regulatory Support Branch (7101M), Office of Chemical
Safety and Pollution Prevention, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 566-1205; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. What information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)),
EPA specifically solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What information collection activity or ICR does this action apply
to?

    Title: Foreign Purchaser Acknowledgement Statement.
    ICR numbers: EPA ICR No. 0161.16, and OMB Control No. 2070-0027.
    ICR status: This ICR is currently scheduled to expire on December
31, 2022. 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. The OMB control numbers for EPA's
regulations in title 40 of the Code of Federal Regulations (CFR), after
appearing in the Federal Register when approved, are displayed either
by publication in the Federal Register or by other appropriate means,
such as on the related collection instrument or form, if applicable.
The display of OMB control numbers for certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: This ICR addresses the information collection activities
associated with the requirement that the EPA receive notice from
pesticide registrants that foreign purchasers of unregistered
pesticides exported from the United States. This statement is to
ascertain understanding that the pesticide product cannot be sold in
the United States. Section 17(a)(2) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) requires an exporter of any
pesticide not registered under FIFRA section 3 or sold under FIFRA
section 6(a)(1) to obtain a signed statement from the foreign purchaser
acknowledging that the purchaser is aware that the pesticide is not
registered for use in, and cannot be sold in, the United States. A copy
of this statement, which is known as the Foreign Purchaser
Acknowledgement Statement, or FPAS, must be transmitted, by EPA, to the
Designated National Authority or appropriate official of the government
in the importing country. This information is submitted via mail or
electronically through the Central Data Exchange (CDX) in the form of
annual or per-shipment statements to EPA, which maintains original
records and transmits copies, along with an explanatory letter, via
email to appropriate government officials of the countries that are
importing the pesticide.
    In addition to the export notification for unregistered pesticides,
FIFRA requires that all exported pesticides include appropriate
labeling. There are different requirements for registered and
unregistered products. For registered products, export labeling
requirements alone meet the definition of third-party notification. In
the interests of consolidating various related information collection
requests, this ICR includes burden estimates for the FPAS requirement
for unregistered pesticides, as well as the labeling requirement for
all exported pesticides, both registered and unregistered. These
burdens have been consolidated in this ICR since the implementation of
the 1993 pesticide export policy governing the export of pesticides,
devices, and active ingredients used in producing pesticides.
    The ICR, which is available in the docket along with other related
materials, provides a detailed explanation of the collection activities
and the burden estimate that is only briefly summarized here.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 1.06
hours per response. Burden is defined in 5 CFR 1320.3(b).
    Respondents/Affected Entities: Entities potentially affected by
this ICR are individuals or entities engaged that either manufacture
and export pesticides or that reformulate or repackage and export
pesticides. The North American Industrial Classification System (NAICS)
code assigned to the parties responding to this information is 3250A1.
    Respondent's obligation to respond: Mandatory under FIFRA section
17(a)(2).
    Estimated total number of potential respondents: 2,240.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent:
5,014.
    Estimated total annual burden hours: 16,660 hours.
    Estimated total annual costs: $1,265,501, which includes an
estimated cost of $0 for capital investment or maintenance and
operational costs.

III. Are there changes in the estimates from the last approval?

    There is no change in burden from that currently approved by OMB.
There were adjustments to the Agency burden estimate related to the
ongoing COVID 19 public health emergency, during which EPA has had
limited access to regular mail since March 2020, which prompted EPA to
announce a temporary COVID 19 flexibility to allow for secure
electronic submissions (86 FR 46246, August 18, 2021) (FRL-8721-01-
OCSPP). Given this circumstance, EPA cannot yet estimate the annual
changes in the number of submissions based on historical data about
submission over the last 3 years, and/or changes in

burden since the existing ICR was approved by OMB. Instead, this ICR
relies on previous estimates and assumes the numbers have largely
remained steady over the past 3 years.
    In addition, OMB has requested that EPA move towards using the 18-
question format for ICR Supporting Statements used by other federal
agencies and departments and is based on the submission instructions
established by OMB in 1995, replacing the alternate format developed by
EPA and OMB prior to 1995. The Agency does not expect this change in
format to result in substantive changes to the information collection
activities or related estimated burden and costs.

IV. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to
announce the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the person listed under FOR
FURTHER INFORMATION CONTACT.
    Authority: 44 U.S.C. 3501 et seq.

    Dated: February 23, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2022-04230 Filed 2-28-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: November 3, 2005 (Volume 70, Number 212)]
[Notices]
[Page 66825]
[DOCID:fr03no05-34]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-49-000]

Columbia Gulf Transmission Company; Notice of Proposed Changes in
FERC Gas Tariff

October 27, 2005.
    Take notice that on October 25, 2005, Columbia Gulf Transmission
Company (Columbia Gulf) tendered for filing as part of its FERC Gas
Tariff, Second Revised Volume No. 1, Seventh Revised Sheet No. 216,
with a proposed effective date of November 24, 2005.
    Columbia Gulf states it is proposing to revise section 19 of the
general terms and conditions (GTC) of its Tariff in order to replace
the existing fixed price penalties with penalties based on a daily
indexed price.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing an
intervention or protest on or before the intervention or protest date
need not serve motions to intervene or protests on persons other than
the Applicant.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E5-6080 Filed 11-2-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36892-36893]
[FR Doc No: 2015-15721]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA 2015-0083]

Agency Information Collection Activities; Revision of a
Currently-Approved Information Collection: Licensing Applications for
Motor Carrier Operating Authority

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for its
review and approval. The FMCSA seeks approval to revise an ICR titled,
``Licensing Applications for Motor Carrier Operating Authority,'' that
is used by for-hire motor carriers of regulated commodities, motor
passenger carriers, freight forwarders, property brokers, and certain
Mexico-domiciled motor carriers to register their operations with the
FMCSA. On April 3, 2015, FMCSA published a Federal Register notice
allowing for a 60-day comment period on this ICR. The agency received
no comments in response to that notice.

DATES: Please send your comments to this notice by July 27, 2015. OMB
must receive your comments by this date to act quickly on the ICR.

ADDRESSES: All comments should reference Federal Docket Management
System (FDMS) Docket Number FMCSA-2015-0083. Interested persons are
invited to submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the attention
of the Desk Officer, Department of Transportation/Federal Motor Carrier
Safety Administration, and sent via electronic mail to
<EMAIL_ADDRESS>faxed to<PHONE_NUMBER>, or mailed to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Docket Library, Room 10102, 725 17th Street NW., Washington, DC
20503.

FOR FURTHER INFORMATION CONTACT: Ms. Vivian Oliver, Transportation
Specialist, Office of Information Technology, Information Technology
Operations Division, Department of Transportation, Federal Motor
Carrier Safety Administration, 6th Floor, West Building, 1200 New
Jersey Ave. SE., Washington DC 20590, Telephone Number<PHONE_NUMBER>;
Email Address<EMAIL_ADDRESS>Office hours are from 9:00 a.m. to
5:00 p.m., Monday through Friday, except Federal Holidays.

SUPPLEMENTARY INFORMATION:
    Title: Licensing Applications for Motor Carrier Operating
Authority.
    OMB Control Number: 2126-0016.
    Type of Request: Revision of a currently-approved information
collection.
    Respondents: Certain Mexico-domiciled motor carriers.
    Estimated Number of Respondents: 12.
    Estimated Time per Response: 4 hours to complete Form OP-1 (MX).
    Expiration Date: October 31, 2015.
    Frequency of Response: Other (as needed).
    Estimated Total Annual Burden: 48 hours [12 annual Form OP-(MX)
responses x 4 hours to complete each response = 48].

    Background: The FMCSA is authorized to register certain for-hire
Mexico-domiciled long-haul motor carriers of regulated commodities
under the provisions of 49 U.S.C. 13902 and the North American Free
Trade Agreement (NAFTA) motor carrier access provision. The Form OP-
1(MX) is used by FMCSA to register those Mexico-domiciled motor
carriers. It requests information on the applicant's identity,
location, familiarity with safety requirements, and type of proposed
operations. This ICR is being revised due to a Final Rule titled,
``Unified Registration System,'' (78 FR 52608), dated August 23, 2013,
that will incorporate all registration form requirements included in
this ICR, except the Form OP-1(MX), into the Form MCSA-1 in the OMB
Control Number 2126-0051, ``FMCSA Registration/Updates,'' ICR effective
October 23, 2015. The Form OP-1(MX) was excluded from the Form MCSA-1
because its information collection requirements are beyond the scope of
the Unified Registration System Final Rule.
    Public Comments Invited:
    FMCSA requests that you comment on any aspect of this information
collection, including: (1) Whether the proposed collection is necessary
for FMCSA to perform its functions, (2) the accuracy of the estimated
burden, (3) ways for the FMCSA to enhance the quality, usefulness, and
clarity of the collected information, and (4) ways that the burden
could be minimized without reducing the quality of the collected
information. The agency will summarize or include your comments in the
request for OMB's clearance of this information collection.

    Issued under the authority delegated in 49 CFR 1.87 on: June 19,
2015.
G. Kelly Regal,
Associate Administrator, Office of Research and Information Technology.
[FR Doc. 2015-15721 Filed 6-25-15; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 81, Number 211 (Tuesday, November 1, 2016)]
[Notices]
[Pages 75820-75821]
[FR Doc No: 2016-26372]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-R07-OW-2016-0602; FRL-9954-74-Region 7]

Notice of Approval of the Primacy Revision Application for the
Public Water Supply Supervision Program from the State of Missouri

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of approval and solicitation of requests for a public
hearing.

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

SUMMARY: The Environmental Protection Agency (EPA) is hereby giving
notice that the State of Missouri is revising its approved Public Water
Supply Supervision Program delegated to the Missouri Department of
Natural Resources. EPA has reviewed the application and intends to
approve these program revisions.

DATES: This determination to approve the Missouri program revision is
made pursuant to 40 CFR 142.12(d) (3). This determination shall become
final and effective on December 1, 2016, unless (1) a timely and
appropriate request for a public hearing is received or (2) the
Regional Administrator elects to hold a public hearing on his own
motion. Any interested person, other than Federal Agencies, may request
a public hearing.
    A request for a public hearing must be submitted to the Regional
Administrator at the address shown below by December 1, 2016. If a
request for a public hearing is made within the requested thirty-day
time frame, a public hearing will be held and a notice will be given in
the Federal Register and a newspaper of general circulation. Frivolous
or insubstantial requests for a hearing may be denied by the Regional
Administrator. If no timely and appropriate request for a hearing is
received, and the Regional Administrator does not elect to hold a
hearing on his own motion, this determination will become effective on
December 1, 2016.
    All interested parties may request a public hearing on the approval
to the Regional Administrator at the EPA Region 7 address shown below.

ADDRESSES: Any request for a public hearing shall include the following
information: (1) Name, address and telephone number of the individual,
organization or other entity requesting a hearing; (2) a brief
statement of the requesting person's interest in the Regional
Administrator's determination and a brief statement on information that
the requesting person intends to submit at such hearing; (3) the
signature of the individual making the request or, if the request is
made on behalf of an organization or other entity, the signature of a
responsible official of the organization or other entity. Requests for
Public Hearing shall be addressed to: Regional Administrator,
Environmental Protection Agency, Region 7, 11201 Renner Boulevard,
Lenexa, Kansas 66219.
    All documents relating to this determination are available for
inspection between the hours of 9:00 a.m. and 3:00 p.m., Monday through
Friday at the following offices: (1) U.S. Environmental Protection
Agency, Region 7, Water Wetlands and Pesticides Division, Drinking
Water Management Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219
and (2) the Missouri Department of Natural Resources, Lewis and Clark
State Office Building, 1101 Riverside Drive, Jefferson City, Missouri
65102.
    Submit your comments, identified by Docket ID No. EPA-R07-OW-2016-
0602, to http://www.regulations.gov. Follow the online instructions for
submitting comments. Once submitted, comments cannot be edited or
removed from Regulations.gov. The EPA may publish any comment received
to its public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Neftali Hernandez, Environmental
Protection Agency, Region 7, Drinking Water Management Branch, (913)
551-7036, or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The EPA is hereby giving notice that the
State of Missouri is revising its approved Public Water Supply
Supervision Program delegated to the Missouri Department of Natural
Resources. The Missouri Department of Natural Resources revised their
program by incorporating the following EPA National Primary Drinking
Water Regulation: Ground Water Rule (November 8, 2006, 71 FR 65574).
EPA has reviewed the application and determined that the revisions are
no less stringent than the corresponding Federal regulations and that
the State of Missouri continues to meet all requirements for primary
enforcement responsibility as specified in 40 CFR 142.10. Therefore,
EPA intends to approve these program revisions.

(Authority: Section 1413 of the Safe Drinking Water Act, as amended,
and 40 CFR 142.10, 142.12(d) and 142.13)

    Dated: October 19, 2016.
Mark Hague,
Regional Administrator, Region 7.
[FR Doc. 2016-26372 Filed 10-31-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: July 21, 2009 (Volume 74, Number 138)]
[Rules and Regulations]
[Page 35795-35797]
[DOCID:fr21jy09-12]

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

DEPARTMENT OF TRANSPORTATION

14 CFR Part 97

[Docket No. 30677; Amdt. No. 3331]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective July 21, 2009. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of July 21, 2009.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue, SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169; or
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_
federal_regulations/ibr_locations.html.
    Availability_All SIAPs are available online free of charge. Visit
nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff
Minimums and ODP copies may be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue, SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure
Standards Branch (AFS-420) Flight Technologies and Programs Division,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National

Flight Data Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is
incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR
part 51, and Sec.  97.20 of Title 14 of the Code of Federal
Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAP and the corresponding effective dates. This
amendment also identifies the airport and its location, the procedure
and the amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP as amended in the transmittal. For safety and
timeliness of change considerations, this amendment incorporates only
specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
    The SIAPs, as modified by FDC P-NOTAM, and contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these changes to
SIAPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts. The circumstances which created the need for all
these SIAP amendments requires making them effective in less than 30
days.
    Because of the close and immediate relationship between these SIAPs
and safety in air commerce, I find that notice and public procedure
before adopting these SIAPs are impracticable and contrary to the
public interest and, where applicable, that good cause exists for
making these SIAPs effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference, and
Navigation (Air).

    Issued in Washington, DC, on July 10, 2009.
John M. Allen,
Director, Flight Standards Service.

Adoption of the Amendment

0
Accordingly, pursuant to the authority delegated to me, Title 14, Code
of Federal regulations, Part 97, 14 CFR part 97, is amended by amending
Standard Instrument Approach Procedures, effective at 0901 UTC on the
dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Sec. Sec.  97.23, 97.25, 97.27, 97.29, 97.31, 97.33 and
97.35  [Amended]

    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

----------------------------------------------------------------------------------------------------------------
    FDC date        State           City             Airport        FDC No.                 Subject
----------------------------------------------------------------------------------------------------------------
06/26/09.......  CT          GROTON/NEW LONDON  GROTON-NEW LONDON     9/5843  RNAV (GPS) RWY 5, ORIG-A.
06/26/09.......  CT          GROTON/NEW LONDON  GROTON-NEW LONDON     9/5844  RNAV (GPS) RWY 23, ORIG.
06/29/09.......  WA          RICHLAND.........  RICHLAND.........     9/6164  RNAV (GPS) RWY 19, ORIG-A.
06/29/09.......  WA          RICHLAND.........  RICHLAND.........     9/6165  RNAV (GPS) RWY 26, ORIG-A.
07/01/09.......  CA          CRESCENT CITY....  MC NAMARA FIELD..     9/6439  VOR/DME RWY 11, AMDT 12.
07/01/09.......  WA          BELLINGHAM.......  BELLINGHAM INTL..     9/6502  RNAV (GPS) RWY 34, ORIG.
07/01/09.......  CO          HOLYOKE..........  HOLYOKE..........     9/6548  RNAV (GPS) RWY 14, ORIG.
07/01/09.......  CO          HOLYOKE..........  HOLYOKE..........     9/6549  RNAV (GPS) RWY 32, ORIG.
07/07/09.......  OH          PORT CLINTON.....  CARL R. KELLER        9/7334  NDB RWY 27, AMDT 13.
                                                 FIELD.
07/09/09.......  CA          COLUSA...........  COLUSA COUNTY....     9/7756  GPS RWY 31, ORIG-A.
07/09/09.......  CA          COLUSA...........  COLUSA COUNTY....     9/7757  GPS RWY 13, ORIG.
07/09/09.......  CA          COLUSA...........  COLUSA COUNTY....     9/7758  VOR-A, AMDT 4C.
----------------------------------------------------------------------------------------------------------------

[FR Doc. E9-17107 Filed 7-20-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 129 (Friday, July 7, 2017)]
[Rules and Regulations]
[Pages 31468-31471]
[FR Doc No: 2017-14339]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0013; FRL-9962-15]

Flonicamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
flonicamid in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective July 7, 2017. Objections and
requests for hearings must be received on or before September 5, 2017,
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-2016-0013, 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 L. Goodis, Director,
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
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2016-0013 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
September 5, 2017. 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-2016-0013, 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 May 19, 2016 (81 FR 31581) (FRL-9946-
02), 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)
5E8428 submitted by IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition requests that 40 CFR 180.613 be
amended by establishing tolerances for residues of the fungicide
flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide,
and its metabolites, TFNA (4-trifluoromethylinicotinic acid), TFNA-AM
(4-trifluoromethylnicotinamide), and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric
equivalent of flonicamid, in or on pea and bean, dried shelled, except
soybean, subgroup 6C at 3.0 parts per million (ppm); Pea and bean,
succulent shelled, subgroup 6B at 6.0 ppm; and Vegetable, legume,
edible podded, subgroup 6A at 4.0 ppm. This petition contains an
additional request to increase the existing tolerance on Vegetable,
fruiting, group 8-10 from 0.4 to 1.50 ppm, but EPA has already taken
action on that specific request, in a final tolerance rule published in
the Federal Register on May 11, 2017 (82 FR 21941) (FRL-9959-91).
    A summary of the petition prepared by ISK Biosciences Corporation,
the registrant, is available in the docket, http://www.regulations.gov,
at docket #: EPA-HQ-OPP-2016-0013. One comment was received on the
notice of filing. EPA's response to the comment is discussed in Unit
IV.C.
    Based upon review of the data supporting the petition, EPA is
establishing a tolerance for Pea and bean, succulent shelled, subgroup
6B that varies slightly from what the petitioner requested. The reason
for this change is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for flonicamid including exposure
resulting from the tolerances established by this action, consistent
with FFDCA section 408(b)(2).
    In the Federal Register of May 11, 2017 (82 FR 21941) (FRL-9959-
91), EPA established tolerances for residues of flonicamid in or on
several commodities. The risk assessments supporting that action
aggregated dietary and non-occupational exposures from existing and
proposed uses of flonicamid, including from the exposures associated
with the tolerances requested in this action. That assessment, which
included the tolerances in today's action, concluded that the
tolerances are safe; therefore, EPA is relying upon that Federal
Register document and the risk assessments supporting the findings in
that document to support the safety finding for the tolerances that are
the subject of this action.
    Specific information on the studies received and the nature of the
adverse effects caused by flonicamid as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document, ``Subject: Flonicamid. Human
Health Risk Assessment for New Uses on Legume Vegetables, Subgroups 6A,
6B, and 6C; Add Directions for use on Greenhouse Grown Peppers and
Increase the Tolerance for Residues on Fruiting Vegetables, Group 8-10;
New Use on Citrus Fruits, Group 10-10; and a Tolerance without U.S.
Registration for residues in/on Dried Tea'' in docket ID number, EPA-
HQ-OPP-2016-0013.
    Based on the findings of the May 11, 2017 Federal Register document
and the supporting documents, EPA concludes that there is a reasonable

certainty that no harm will result to the general population, or to
infants and children from aggregate exposure to flonicamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (FMC Method No. P-3561M, a liquid
chromatography with tandem mass spectrometry (LC/MS/MS) method) is
available to enforce the tolerance expression for flonicamid and its
metabolites in or on plant commodities.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<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.
    The Codex has not established a MRL for flonicamid.

C. Response to Comments

    Comment: One anonymous comment on the notice of filing of petition
5E8428 was received. The commenter claims that flonicamid is a ``toxic
pesticide'' and residues at any level in food commodities should not be
allowed and requested that EPA deny setting tolerances for the
petition-for new uses of flonicamid. The comment stated that the
proposed flonicamid use would add to about 25,000 toxic chemicals
currently in the environment and combine to create even more toxic
chemical residues in food and drinking water further increasing harmful
effects to humans and environment.
    Agency response: The Agency recognizes that some individuals
believe that pesticides should be banned completely. However, under the
existing legal framework provided by FFDCA section 408, EPA is
authorized to establish pesticide tolerances or exemptions where
persons seeking such tolerances or exemptions have demonstrated that
the pesticide meets the safety standard imposed by that statute. In
this instance, EPA has examined all the relevant and available data and
concluded that the tolerances are safe. The commenter has not provided
any information to support a conclusion by the Agency that the
tolerances are not safe.

D. Revisions to Petitioned-For Tolerances

    EPA is establishing a slightly higher tolerance for Pea and bean,
succulent shelled, subgroup 6B at 7.0 ppm compared to the petitioner's
request of a tolerance at 6.0 ppm. EPA's decision is based on the
Organization for Economic Cooperation and Development (OECD) tolerance
calculation procedures and available field trial data.

V. Conclusion

    Therefore, tolerances are established for residues of flonicamid,
N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, and its
metabolites, TFNA (4-trifluoromethylinicotinic acid), TFNA-AM (4-
trifluoromethylnicotinamide), and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric
equivalent of flonicamid, in or on Pea and bean, succulent shelled,
subgroup 6B at 7.0 ppm; Pea and bean, dried shelled, except soybean,
subgroup 6C at 3.0 ppm; and Vegetable, legume, edible podded, subgroup
6A at 4.0 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). 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: June 2, 2017.
Michael L. 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.  180.613, add alphabetically the following commodities ``Pea
and bean, succulent shelled, subgroup 6B''; ``Pea and bean, dried
shelled, except soybean, subgroup 6C''; and ``Vegetable, legume, edible
podded, subgroup 6A'' to the table in paragraph (a)(1) to read as
follows:

Sec.  180.613  Flonicamid; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                              million
------------------------------------------------------------------------

                                * * * * *
Pea and bean, succulent shelled, subgroup 6B.................        7.0
Pea and bean, dried shelled, except soybean, subgroup 6C.....        3.0

                                * * * * *
Vegetable, legume, edible podded, subgroup 6A................        4.0

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-14339 Filed 7-6-17; 8:45 am]
 BILLING CODE 6560-50-P