[Federal Register Volume 76, Number 125 (Wednesday, June 29, 2011)]
[Notices]
[Pages 38235-38237]
[FR Doc No: 2011-16225]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64730; File No. SR-NYSEArca-38]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Adopting New NYSE
Arca Equities Rule 7.41 to Codify Outbound and Inbound Routing
Functions Performed by Its Affiliate Broker-dealer, Archipelago
Securities LLC

June 23, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on June 16, 2011, NYSE Arca, Inc. (the ``Exchange'' or ``NYSE
Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by NYSE Arca. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes new NYSE Arca Equities Rule 7.41 to codify
outbound and inbound routing functions performed by its affiliate
broker-dealer, Archipelago Securities LLC (``Arca Securities''). The
text of the proposed rule change is available at the Exchange's
principal office, at http://www.nyse.com, at the Commission's Public
Reference Room, and at the Commission's Web site at http://www.sec.gov.

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

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

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

1. Purpose
    The Exchange proposes new NYSE Arca Equities Rule 7.41 to codify
outbound and inbound routing functions performed by its affiliate
broker-dealer, Arca Securities, which have previously been approved by
the Commission.\3\
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    \3\ The Exchange's affiliates, New York Stock Exchange, LLC
(``NYSE'') and NYSE Amex LLC (``NYSE Amex''), are proposing
substantially similar rule changes. See SR-NYSE-2011-24 and SR-
NYSEAmex-2011-39.
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Background--Arca Securities Functions as Routing Broker
    Arca Securities currently is the primary outbound and inbound
routing broker for NYSE Arca. The terms of the outbound routing
function for NYSE Arca are generally set forth in the Commission's
approval orders,\4\ rather than rule text,\5\ and permit NYSE Arca to
utilize Arca Securities to route orders to an away market center for
execution whenever such routing is required by Exchange Rules and
federal securities laws. The terms of the outbound routing function of
Arca Securities generally are as follows:
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    \4\ See Securities Exchange Act Release No. 52497 (September 22,
2005), 70 FR 56949, 56952-56953 (September 29, 2005) (SR-PCX-2005-
90).
    \5\ NYSE Arca Equities Rule 7.31 sets forth order types
available for trading on the Exchange, including those that may
route to another market center, and NYSE Arca Equities Rule 1.1(qq)
defines the term ``Routing Agreement.''
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    Arca Securities operates and is regulated as a facility of the
Exchange, subject to and consistent with Section 6 of the Securities
Exchange Act of 1934 (``Act'').
    A self-regulatory organization (``SRO'') unaffiliated with the
Exchange or any of its affiliates (currently the Financial Industry
Regulatory Authority or ``FINRA''), carries out oversight and
enforcement responsibilities as the Designated Examining Authority
(``DEA'') designated by the Commission pursuant to Rule 17-1 of the Act
with the responsibility for examining Arca Securities for compliance
with the applicable financial responsibility rules.
    The agreement between the Exchange and FINRA pursuant to Rule 17-2
under the Act allocates to FINRA the responsibility to receive
regulatory reports from Arca Securities, to examine Arca Securities for
compliance and to enforce compliance by Arca Securities with the Act,
the rules and regulations thereunder and FINRA rules, and to carry out
other specified regulatory functions with respect to Arca Securities.
    ETP Holders' use of Arca Securities to route orders to another
market center from the Exchange is optional.\6\
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    \6\ An ETP Holder that does not want to use Arca Securities may
use other routers to route orders to other market centers or choose
to send an order to the Exchange that, if not executable on the
Exchange, will be cancelled and returned to the ETP Holder, at which
time the ETP Holder could choose to route the order to another
market itself.
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    Arca Securities will not engage in any business other than its
outbound routing function (including, in that function, the self-
clearing functions that it currently performs for trades with respect
to orders routed to other market centers) and other activities approved
by the Commission.
    The operation of Arca Securities as a facility of the Exchange
providing outbound routing services is subject to Exchange and
Commission oversight and the Exchange must file with the Commission
rule changes and fees relating to Arca Securities.
    The inbound routing function of Arca Securities currently is
governed by a pilot program established to permit Arca Securities to
route orders from NYSE and NYSE Amex to NYSE Arca.\7\ The

pilot was extended and is currently scheduled to expire on September
30, 2011.\8\ The terms of the inbound routing pilot are generally set
forth in the Commission's approval orders, rather than rule text
(except as noted below).\9\ The terms of the pilot are as follows:
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    \7\ See Securities Exchange Act Release No. 58681 (September 29,
2008), 73 FR 58285 (October 6, 2008) (SR-NYSEArca-2008-90). See also
Securities Exchange Act Release No. 59010 (November 24, 2008), 73 FR
73373 (December 2, 2008) (SR-NYSEArca-2008-130).
    \8\ See Securities Exchange Act Release Nos. 60750 (September
30, 2009), 74 FR 51635 (October 7, 2009) (SR-NYSEArca-2009-87)
(extending pilot from September 29, 2009 to December 31, 2009);
61247 (December 31, 2009), 75 FR 1096 (January 8, 2010) (SR-
NYSEArca-2009-115) (extending pilot from December 31, 2009 to March
31, 2010); 61813 (March 31, 2010), 75 FR 17459 (April 7, 2010) (SR-
NYSEArca-2010-19) (extending pilot from March 31, 2010 to September
30, 2010); 62883 (September 2, 2010), 75 FR 55382 (September 10,
2010) (SR-NYSEArca-2010-82) (extending pilot from September 30, 2010
to March 31, 2011); and 64042 (March 2, 2011), 76 FR 13440 (March 8,
2011) (SR-NYSEArca-2011-06) (extending pilot from March 31, 2011 to
September 30, 2011).
    \9\ See supra note 9.
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    The Exchange and the Financial Industry Regulatory Authority
(``FINRA'') have entered into a Rule 17d-2 agreement pursuant to which
FINRA is allocated regulatory responsibilities to review Arca
Securities' compliance with certain Exchange rules. The Exchange,
however, retains ultimate responsibility for enforcing its rules with
respect to Arca Securities.
    NYSE Regulation monitors Arca Securities for compliance with the
Exchange's trading rules and collects and maintains certain related
information. Specifically, NYSE Regulation collects and maintains the
following information of which NYSE Regulation staff becomes aware--
namely, all alerts, complaints, investigations and enforcement actions
where Arca Securities is identified as a participant that has
potentially violated Exchange or applicable SEC rules--in an easily
accessible manner so as to facilitate any review conducted by the SEC's
Office of Compliance Inspections and Examination.
    NYSE Regulation has agreed with the Exchange that it will provide a
report to the Exchange's Chief Regulatory Officer, on a quarterly
basis, that (i) Quantifies all alerts (of which NYSE Regulation is
aware) that identify Arca Securities as a participant that has
potentially violated Exchange or SEC rules, and (ii) quantifies the
number of all investigations that identify Arca Securities as a
participant that has potentially violated Exchange or Commission rules.
    NYSE Euronext, as parent of the Exchange, was obligated to adopt a
rule requiring it to establish and maintain procedures and internal
controls reasonably designed to ensure that Arca Securities does not
develop or implement changes to its system, based on non-public
information obtained regarding planned changes to the Exchange's
systems as a result of its affiliation with the Exchange, until such
information is available generally to similarly situated ETP Holders of
the Exchange.\10\
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    \10\ See supra note 9. See also NYSE Arca Equities Rule 14.3(e).
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    Since the initiation of the inbound routing pilot in 2008, the
Exchange in 2010 entered into a comprehensive Regulatory Services
Agreement (``RSA'') with FINRA that, among other things, allocated to
FINRA responsibility for the functions noted above that NYSE Regulation
previously performed with respect to Arca Securities (e.g., monitoring
Arca Securities' compliance with the Exchange's trading rules).\11\ As
a result of this RSA and the Rule 17d-2 agreement, the only regulatory
functions related to Arca Securities that remain with NYSE Regulation
are the provision to FINRA of the exceptions noted above of which NYSE
Regulation becomes aware (e.g., alerts involving Arca Securities) and
the receipt of the quarterly report noted above, which is now produced
by FINRA.
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    \11\ The Exchange notes that FINRA reviews both inbound and
outbound routing via Arca Securities pursuant to the 17d-2 agreement
and the RSA. The Exchange will review the terms of the RSA in
connection with this proposed rule change, and will amend it to
reflect the specific terms of this filing.
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Proposed Rule Change
    In order to provide more clarity and transparency to all of the
functions that Arca Securities performs on behalf of the Exchange, NYSE
Arca proposes to add NYSE Arca Equities Rule 7.41 to define the term
``Routing Broker'' and describe the outbound and inbound routing
functions. By doing so, the Exchange would establish a single, central
location in its Rules describing all routing broker functions,
including both outbound and inbound routing. The proposed rule text in
Rule 7.41 would be substantially the same as the language set forth in
the Commission notices applicable to the Exchange and virtually
identical to rule text already implemented for other exchanges.
    In this regard, the rule text covering outbound routing would be
virtually identical to the NYSE's rule text covering outbound routing
by NYSE,\12\ and would track the terms of the outbound routing language
noted above. In addition, the rule text covering inbound routing would
be virtually identical to the BATS' rule text covering inbound routing
by BATS, and would track the terms of the inbound routing pilot noted
above (and as set forth in the rule filings), with the following
exceptions.\13\ First, the rule text would reflect that certain
regulatory functions are now carried out by FINRA on behalf of NYSE
Regulation, rather than by NYSE Regulation directly. Second, the rule
text would require procedures and controls that are reasonably designed
to prevent Arca Securities from receiving any benefit, taking any
action or engaging in any activity, based on non-public information
regarding planned changes to Exchange systems obtained as a result of
its affiliation with the Exchange, until such information is available
generally to similarly situated Exchange ETP Holders, in connection
with the provision of inbound order routing to the Exchange.\14\ In
comparison, the current language from the inbound routing pilot
requires procedures and controls that are reasonably designed to ensure
that Arca Securities does not develop or implement changes to its
system, based on non-public information obtained regarding planned
changes to the Exchange's systems as a result of its affiliation with
the Exchange, until such information is available generally to
similarly situated Exchange ETP Holders. The Exchange also proposes to
include specific rule text to codify the current date upon which the
inbound routing pilots are set to expire--September 30, 2011.
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    \12\ See NYSE Rule 17(c).
    \13\ See BATS Rule 2.12. See also Securities Exchange Act
Release No. 62901 (September 13, 2010), 75 FR 57097 (September 17,
2010) (SR-BATS-2010-024).
    \14\ The Exchange notes that the text proposed in Rule
7.41(c)(2) would make clear that the Exchange may furnish to Arca
Securities the same information on the same terms that the Exchange
makes available in the normal course of business to any other ETP
Holder.
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2. Statutory Basis

    The proposed rule change is consistent with Section 6(b) \15\ of
the Act, in general, and furthers the objectives of Section
6(b)(5),\16\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system and, in general, to protect
investors and the public interest. The Exchange believes

that the proposed rule change, which would add specific rule text for
routing functionality that has already been approved in substance by
the Commission for the Exchange, would enhance the clarity and
transparency surrounding such functionality, including the
responsibilities and obligations attendant therewith, while also
reflecting the Exchange's ongoing efforts to effectively address the
concerns previously identified by the Commission regarding the
potential for informational advantages favoring Arca Securities vis-
[agrave]-vis other non-affiliated NYSE Arca ETP Holders. The Exchange
also believes that the proposed rule change would support the
principles of Section 11A(a)(1) of the Act \17\ in that it seeks to
assure economically efficient execution of securities transactions.
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    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(5).
    \17\ 15 U.S.C. 78k-1(a)(1).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the proposed rule change: (i) Does not significantly affect
the protection of investors or the public interest; (ii) does not
impose any significant burden on competition; and (iii) does not become
operative for 30 days after the date of the filing, or such shorter
time as the Commission may designate if consistent with the protection
of investors and the public interest, the proposed rule change has
become effective pursuant to Section 19(b)(3)(A) of the Act \18\ and
Rule 19b-4(f)(6) thereunder.\19\
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    \18\ 15 U.S.C. 78s(b)(3)(A).
    \19\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under 19b-4(f)(6) normally may not
become operative prior to 30 days after the date of filing.\20\
However, Rule 19b-4(f)(6)(iii) \21\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange requests that the
Commission waive the 30-day operative delay. The Exchange believes that
waiver of the 30-day operative delay would provide more clarity and
transparency in its rule text concerning all of the functions that Arca
Securities performs on behalf of the Exchange without undue delay. In
addition, the Exchange notes that the proposal is consistent with the
rules of another national securities exchange. For these reason, the
Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest,
and designates the proposed rule change to be operative upon filing
with the Commission.\22\
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    \20\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires that a self-regulatory organization submit to
the Commission written notice of its intent to file the proposed
rule change, along with a brief description and text of the proposed
rule change, at least five business days prior to the date of filing
of the proposed rule change, or such shorter time as designated by
the Commission. The Exchange has satisfied this requirement.
    \21\ Id.
    \22\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2011-38 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2011-38. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of the filing also will be
available for inspection and copying at the principal office of the
Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NYSEArca-2011-38 and should be submitted on or before July 20, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
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    \23\17 CFR 200.30-3(a)(12).
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Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-16225 Filed 6-28-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 74, Number 79 (Monday, April 27, 2009)]
[Notices]
[Pages 19107-19108]
[FR Doc No: E9-9518]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

Maritime Advisory Committee for Occupational Safety and Health
(MACOSH)

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: MACOSH meeting, notice of.

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SUMMARY: The Maritime Advisory Committee for Occupational Safety and
Health (MACOSH) was established under Section 7 of the Occupational
Safety and Health (OSH) Act of 1970 to advise the Assistant Secretary
of Labor for Occupational Safety and Health Administration (OSHA) on
issues relating to occupational safety and health in the maritime
industries. The purpose of this Federal Register notice is to announce
the Committee and workgroup meetings scheduled for May 19-20, 2009.

DATES: The workgroups will meet on Tuesday, May 19, 2009, 8:30 a.m. to
5 p.m., and the Committee will meet on Wednesday, May 20, 2009, from
8:30 a.m. to 5 p.m.

ADDRESSES: The Committee and workgroups will meet at the Sheraton
Anchorage Hotel, 401 East 6th Avenue, Anchorage, AK 99501 ((907) 276-
8700) in the Howard Rock conference room. The room will be divided into
two conference areas during the Shipyard and Longshoring workgroup
meetings. Mail comments, views, or statements in response to this
notice to Danielle Watson, Office of Maritime, OSHA, U.S. Department of
Labor, Room N-3609, 200 Constitution Avenue, NW., Washington, DC 20210;
phone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For general information about MACOSH
and this meeting, contact: Amy Wangdahl, Acting Director, Office of
Maritime, OSHA, U.S. Department of Labor, Room N-3609, 200 Constitution
Avenue, NW., Washington, DC 20210; phone:<PHONE_NUMBER>. Individuals
with disabilities wishing to attend the meeting should contact Danielle
Watson at<PHONE_NUMBER> no later than May 5, 2009, to obtain
appropriate accommodations.

SUPPLEMENTARY INFORMATION: All MACOSH meetings are open to the public.
All interested persons are invited to attend the MACOSH meeting at the
time and location listed above. The MACOSH agenda will include: an OSHA
activities update; a review of the minutes from the previous meeting;
and reports from each workgroup. MACOSH may also discuss the following
topics based on the workgroup reports: surface preparation (Subpart C,
painting and coatings); Safety and Health Injury Prevention Sheets
(SHIPS) rigging guidance document; arc flash guidance; OSHA webpage
development; commercial fishing industry guidance; OSHA quick cards;
welding guidance; break bulk cargo safety guidance; safety zone
guidance; and speed limits in marine terminals.
    Public Participation: Written data, views, or comments for
consideration by MACOSH on the various agenda items listed above should
be submitted to Danielle Watson at the address listed above.
Submissions received by May 5, 2009, will be provided to Committee
members and will be included in the record of the meeting. Requests to
make oral presentations to the Committee may be granted as time
permits.

    Authority: This notice was prepared under the direction of
Jordan Barab, Acting Assistant Secretary of Labor for Occupational
Safety and Health, U.S. Department of Labor, 200 Constitution
Avenue, NW., Washington, DC 20210, pursuant to Sections 6(b)(1) and
7(b) of the Occupational Safety and Health Act of 1970 (29 U.S.C.
655, 656), the Federal Advisory Committee Act (5 U.S.C. App. 2),
Secretary of Labor's Order 5-2007 (72 FR 31160), and 29 CFR part
1912.

    Signed at Washington, DC, this 21st day of April, 2009.
Jordan Barab,
Acting Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. E9-9518 Filed 4-24-09; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: December 31, 2007 (Volume 72, Number 249)]
[Notices]
[Page 74275-74276]
[DOCID:fr31de07-34]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER07-1278-000; ER07-1278-001; ER07-1278-002]

Alpha Energy Master, Ltd.; Notice of Issuance of Order

December 19, 2007.
    Alpha Energy Master, Ltd. (Alpha Energy) filed an application for
market-based rate authority, with an accompanying tariff. The proposed
market-based rate tariff provides for the sale of energy and capacity
at market-based rates. Alpha Energy also requested waivers of various
Commission regulations. In particular, Alpha Energy requested that the
Commission grant blanket approval under 18 CFR part 34 of all future
issuances of securities and assumptions of liability by Alpha Energy.
    On December 19, 2007, pursuant to delegated authority, the
Director, Division of Tariffs and Market Development-West, granted the
requests for blanket approval under Part 34 (Director's Order). The
Director's Order also stated that the Commission would publish a
separate notice in the Federal Register establishing a period of time
for the filing of protests. Accordingly, any person desiring to be
heard concerning the blanket approvals of issuances of securities or
assumptions of liability by Alpha Energy, should file a protest with
the Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance

with Rules 211 and 214 of the Commission's Rules of Practice and
Procedure. 18 CFR 385.211, 385.214 (2007).
    Notice is hereby given that the deadline for filing protests is
January 18, 2008.
    Absent a request to be heard in opposition to such blanket
approvals by the deadline above, Alpha Energy is authorized to issue
securities and assume obligations or liabilities as a guarantor,
indorser, surety, or otherwise in respect of any security of another
person; provided that such issuance or assumption is for some lawful
object within the corporate purposes of Alpha Energy, compatible with
the public interest, and is reasonably necessary or appropriate for
such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of Alpha Energy's issuance of securities or
assumptions of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the internet in lieu of paper. See, 18 CFR
385.2001(a) (1) (iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-25327 Filed 12-28-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 26 (Friday, February 7, 2020)]
[Notices]
[Pages 7311-7313]
[FR Doc No: 2020-02481]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0825]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket Approval of
Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by March
9, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0231.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Premarket Approval of Medical Devices

OMB Control Number 0910-0231--Extension

    Under section 515 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360e) all devices placed into class III by FDA are
subject to premarket approval application (PMA) requirements. PMA is
the process of scientific and regulatory review to ensure the safety
and effectiveness of class III devices. An approved PMA is, in effect,
a private license granted to the applicant for marketing a particular
medical device. A class III device that fails to meet PMA requirements
is considered to be adulterated under section 501(f) of the FD&C Act
(21 U.S.C. 351(f)) and cannot be marketed. PMA requirements apply
differently to preamendments devices, postamendments devices, and
transitional class III devices.
    Manufacturers of class III preamendments devices (devices that were
in commercial distribution before May 28, 1976) are not required to
submit a PMA until 30 months after the issuance of a final
classification regulation or until 90 days after the publication of a
final regulation requiring the submission of a PMA, whichever period is
later. FDA may allow more than 90 days after issuance of a final rule
for submission of a PMA.
    A postamendments device is one that was first distributed
commercially on or after May 28, 1976. Postamendments devices
determined by FDA to be substantially equivalent to preamendments class
III devices are subject to the same requirements as the preamendments
devices. FDA determines substantial equivalence after reviewing an
applicant's premarket notification submitted in accordance with section
510(k) of the FD&C Act. Postamendments devices determined by FDA to be
not substantially equivalent to either preamendments devices or
postamendments devices classified into class I or II are ``new''
devices and fall automatically into class III. Before such devices can
be marketed, they must have an approved PMA or must be reclassified
into class I or class II.
    The Food and Drug Administration Modernization Act of 1997 (FDAMA)
(Pub. L. 105-115) amended the FD&C Act by streamlining the process of
bringing safe and effective drugs, medical devices, and other therapies
to the U.S. market. FDAMA added section 515(d)(6) to the FD&C Act,
which provided that PMA supplements were required for all device
changes that affect safety and effectiveness unless such changes are
modifications to manufacturing procedures or method of manufacture.
That type of manufacturing change requires a 30-day notice, or where
FDA finds such notice inadequate, a 135-day PMA supplement.
    The implementing regulations, contained in 21 CFR part 814, further
specify the contents of a PMA for a medical device and the criteria FDA
will employ in approving, denying, or withdrawing approval of a PMA and
supplements to PMAs. The regulations' purpose is to establish an
efficient and thorough procedure for FDA's review of PMAs and
supplements to PMAs for class III medical devices. The regulations
facilitate the approval of PMAs and supplements to PMAs for devices
that have been shown to be reasonably safe and effective and otherwise
meet the statutory criteria for approval. The regulations also allow
for the denial of PMAs and supplements to PMAs for devices that have
not been shown to be reasonably safe and effective and that do not
otherwise meet the statutory criteria for approval.
    The burden estimate is based on the annual rate of receipt of PMA
submissions for fiscal years (FYs) 2016 through 2018 and our
expectation of submissions to come in the next few years. The burden
data for PMAs is based on data provided by applicants by device type
and cost element in an earlier study.

Reporting Burden

    Section 814.15(b)--Research Conducted Outside the United States.
FDA will accept information on a clinical investigation conducted
outside the United States (OUS) to support a PMA if the investigation
is well-designed and well-conducted and certain other conditions are
met, including that the investigation was conducted in accordance with
good clinical practice (GCP) as specified in 21 CFR 812.28. If the OUS
clinical investigation did not conform to GCP, then the PMA submission
should include a waiver request or a statement explaining the reason
for not conducting the investigation in accordance with GCP and a
description of steps taken to ensure that the data and results are
credible and accurate and that the rights, safety, and well-being of
subjects have been adequately protected. Based on the number of PMAs
received that contained studies from overseas, FDA estimates that the
burden estimate necessary to meet this requirement is 50 hours.
    Section 814.20--Application. Specifies the information required in
a PMA and update reports such as the applicant's name and address, a
description of the device, its labeling, its indications for use, and
summary of clinical and non-clinical studies. Included in this
requirement is the conduct of laboratory and clinical trials, as well
as the analysis, review, and physical preparation of the PMA
application. FDA estimates that 38 applicants, including hospital
remanufacturers of single-use devices, will be affected by these
requirements, which are based on the actual average of FDA receipt of
new PMA applications in FYs 2016 through 2018.
    Additionally, the ``Human Subject Protection; Acceptance of Data
from

Clinical Investigations for Medical Devices'' final rule (83 FR 7366;
February 21, 2018) amended this section to address requirements for a
PMA supported by data from clinical investigations conducted outside
the United States. The applicant will be required to submit the
information as described in Sec.  814.20(b)(6)(ii)(C). We estimate this
will take 30 minutes per respondent. We estimate that 10 respondents
annually will submit such information.
    The collections in OMB control number 0910-0741, ``Human Subject
Protection; Acceptance of Data from Clinical Studies for Medical
Devices,'' were submitted to OMB as a new information collection
request with the expectation that the currently approved requirements
will be amended. As noted in the Supporting Statement for OMB control
number 0910-0741, we are amending OMB control number 0910-0231 to
reflect the information collections associated with the rulemaking
under Sec.  814.20(b)(6)(ii)(C).
    Section 814.37(a) through (c) and (e)--PMA Amendments and
Resubmitted PMAs. As part of the review process, FDA often requests the
PMA applicant to submit additional information regarding the device
necessary for FDA to file the PMA or to complete its review and make a
final decision. The PMA applicant may, on their own initiative, submit
additional information to FDA during the review process. These
amendments contain information ranging from additional test results and
reanalysis of the original data set to revised device labeling. Almost
all PMAs received by the Agency have amendments submitted during the
review process.
    Section 814.39(a)--PMA Supplements. This information collection
includes the requirements for the range of PMA supplements (panel
track, 180-day fee-based, 180-day non-fee-based, and real-time
supplements).
    Section 814.39(d)--Special PMA Supplements--Changes Being Affected.
This type of supplement is intended to enhance the safety of the device
or the safe use of the device. The number of PMA supplements received
that fit this category averaged 75 per year based on the numbers
received from FYs 2016 through 2018.
    Section 814.39(f)--30-Day Notice. Under section 515(d) of the FD&C
Act, modifications to manufacturing procedures or methods of
manufacture that affect the safety and effectiveness of a device
subject to an approved PMA do not require submission of a PMA
supplement under paragraph (a) of that section and are eligible to be
the subject of a 30-day notice. A 30-day notice shall describe in
detail the change, summarize the data or information supporting the
change, and state that the change has been made in accordance with the
requirements of part 820 (21 CFR part 820). The applicant may
distribute the device 30 days after the date on which FDA receives the
30-day notice, unless FDA notifies the applicant within 30 days from
receipt of the notice that it is not adequate.
    Section 814.82(a)(9)--Postapproval Requirements. Postapproval
requirements concern approved PMAs that were not reclassified and
require a periodic report. After approval, all PMAs require a
submission of an annual report. A majority of the submitted PMAs
require associated postapproval studies, i.e., followup of patients
used in clinical trials to support the PMA or additional preclinical
information that is labor-intensive to compile and complete; the
remaining PMAs require minimal information.
    Section 814.84(b)--Periodic Reports. Postapproval requirements
described in Sec.  814.82(a)(7) require submission of an annual report
for each approved PMA. FDA estimates that respondents will average
about 10 hours in preparing their reports to meet this requirement.
This estimate is based on FDA's experience and consultation with
industry.
    The Breakthrough Devices Program--The Breakthrough Devices Program
supersedes the Expedited Access Pathway and Priority Review for medical
devices. The guidance document ``Breakthrough Devices Program''
implements section 515B of the FD&C Act (21 U.S.C. 360e-3), as created
by section 3051 of the 21st Century Cures Act (Pub. L. 114-255) and
amended by section 901 of the FDA Reauthorization Act of 2017 (Pub. L.
115-52). The Breakthrough Devices Program is a voluntary program for
certain medical devices and device-led combination products that
provide for more effective treatment or diagnosis of life-threatening
or irreversibly debilitating diseases or conditions. The program is
intended to help patients have more timely access to these medical
devices by expediting their development, assessment, and review, while
preserving the statutory standards for premarket approval, 510(k)
clearance, and De Novo marketing authorization, consistent with the
Agency's mission to protect and promote public health.
    Section 520(g)(7) of the FD&C Act (21 U.S.C. 360j(g)(7))--Agreement
Meeting. Applicants planning to submit a PMA may submit a written
request to reach agreement with FDA on the key parameters of the
investigational plan.
    Section 513(a)(3)(D) of the FD&C Act (21 U.S.C. 360c(a)(3)(D))--
Determination Meeting. Applicants planning to submit a PMA may submit a
written request to FDA for a meeting to determine the type of
information (valid scientific evidence) necessary to support the
effectiveness of their device.
    Section 515(c)(3) of the FD&C Act--Panel of Experts. An original
PMA or panel track PMA supplement is taken to an advisory panel of
experts unless FDA determines that the information in the application
substantially duplicates information that has previously been reviewed
by the panel.
    Section 515(d)(3) of the FD&C Act--Day 100 Meeting. FDA must, upon
the written request of the applicant, meet with that party within 100
days of receipt of the filed PMA application to discuss the review
status of the application. With the concurrence of the applicant, a
different schedule may be established. Prior to this meeting, FDA must
inform the applicant in writing of any identified deficiencies and what
information is required to correct those deficiencies. FDA must also
promptly notify the applicant if FDA identifies additional deficiencies
or of any additional information required to complete Agency review.

Recordkeeping

    Section 814.82(a)(5) and (6)--Maintenance of Records. The
recordkeeping burden under this section requires the maintenance of
records used to trace patients, and the organization and indexing of
records into identifiable files to ensure the device's continued safety
and effectiveness. These records are required of all applicants who
have an approved PMA.
    PMAs have been required since 1976, and there are 801 active PMAs
that could be subject to these requirements, based on actual FDA data,
and approximately 39 new PMAs are approved every year. The aggregate
burden for the estimated 446 PMA holders of approved original PMAs for
the next few years is estimated to be 7,582 hours.
    The applicant determines which records should be maintained during
product development to document and/or substantiate the device's safety
and effectiveness. Records required by the current good manufacturing
practices for medical devices regulation (part 820) may be relevant to
a PMA review and may be submitted as part of an application. In
individual instances, records may be required as conditions of

approval to ensure the device's continuing safety and effectiveness.
    In the Federal Register of October 24, 2019 (84 FR 57030), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
 Activity/21 CFR or FD&C Act      Number of     responses per   Total annual     Average burden     Total hours
           section               respondents     respondent       responses       per response
----------------------------------------------------------------------------------------------------------------
Research conducted outside                 25               1              25                  2              50
 the United States
 (814.15(b)).................
PMA application (814.20).....              46               1              46                668          30,728
Information on clinical                    10               1              10   0.5 (30 minutes)               5
 investigations conducted
 outside the United States
 (814.20(b)(6)(ii)(C)).......
PMA amendments and                      1,528               1           1,528                167         255,176
 resubmitted PMAs (814.37(a)-
 (c) and (e))................
PMA supplements (814.39(a))..             777               1             777                 60          46,620
Special PMA supplement--                   75               1              75                  6             450
 changes being affected
 (814.39(d)).................
30-day notice (814.39(f))....           1,722               1           1,722                 16          27,552
Postapproval requirements                 121               1             121                135          16,335
 (814.82(a)(9))..............
Periodic reports (814.84(b)).             764               1             764                 10           7,640
Agreement meeting (520(g)(7))               1               1               1                 50              50
Breakthrough Devices Program               11               1              11                 10             110
 (515(B) of the FD&C Act)....
Determination Meeting                       1               1               1                 50              50
 (513(1)(3)(D) of the FD&C
 Act)........................
Panel meeting (515(c)(3) of                 1               1               1                 30              30
 the FD&C Act)...............
Day 100 meeting (515(d)(3) of              14               1              14                 10             140
 the FD&C Act)...............
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ..............  ..............  .................         384,936
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                      Activity/21 CFR section                           Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of records (814.82(a)(5) and (6))......................             446                1              446               17            7,582
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We made the following changes to the information collection:
     Added the burden estimate for ``Information on clinical
investigations conducted outside the United States (Sec.
814.20(b)(6)(ii)(C)),'' which is associated with the ``Human Subject
Protection; Acceptance of Data from Clinical Investigations for Medical
Devices'' final rule as described previously in this document.
     Revised the burden description and table to reflect that
the Expedited Access Pathway and Priority Review have been superseded
by the Breakthrough Devices Program.
     Updated our burden estimate with FYs 2016 through 2018
data.
    These adjustments resulted in an overall increase of 34,782 hours
to the estimated burden.

    Dated: January 31, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02481 Filed 2-6-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 172 (Thursday, September 3, 2020)]
[Rules and Regulations]
[Pages 54927-54931]
[FR Doc No: 2020-19491]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0351; FRL-10013-43]

Deoxyribonucleic Acid (DNA) Sequences; Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of deoxyribonucleic acid sequences
consisting solely of adenine, cytosine, guanine, and thymine, of 300 or
fewer base pairs, and which do not contain start codons or regulatory
sequences necessary for the initiation of transcription or translation
when used as an inert ingredient (product identifier) in pesticide
formulations applied to growing crops and to raw agricultural
commodities after harvest at a concentration not to exceed 1.0 parts
per million (ppm). InvisiDex Inc. submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment
of an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of deoxyribonucleic acid that satisfy the terms of the
exemption.

DATES: This regulation is effective September 3, 2020. Objections and
requests for hearings must be received on or before November 2, 2020,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0351, 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>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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 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-2017-0351 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
November 2, 2020. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0351, 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.
    For the latest status information on EPA/DC services and docket
access, visit https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of September 15, 2017 (82 FR 43352) (FRL-
9965-43), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11062) by InvisiDex Inc., 1129 Maricopa Hwy. #217, Ojai, CA 93023. The
petition requested that 40 CFR 180.910 be amended by establishing an
exemption from the requirement of a tolerance for residues of
deoxyribonucleic acid (CAS Reg. No. 9006-49-2) when used as an inert
ingredient (product identifier) in pesticide formulations applied to
growing crops and to raw agricultural commodities after harvest at a
concentration not to exceed 1.0 parts per million (ppm). That document
referenced a summary of the petition prepared by InvisiDex Inc., the
petitioner, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing.
EPA's response to this comment is discussed in Unit V.B.

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 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 tolerance is ``safe.'' Section 408(c)(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 . . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks 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 finite 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. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for deoxyribonucleic acid sequences
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with
deoxyribonucleic acid sequences follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. Specific information on the studies received and the nature
of the adverse effects caused

by deoxyribonucleic acid sequences as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies are discussed in this unit.
    Deoxyribonucleic acid (DNA) is routinely synthesized and degraded
by almost all living cells. DNA breakdown into constituent nucleic
acids continuously occurs in living cells. Purine and pyrimidine
nucleosides can either be degraded to waste products and excreted or
can be salvaged as nucleotide components. Therefore, metabolites of DNA
do not pose a toxicological risk.
    DNA sequences used as product identifiers contain the same nucleic
acids as DNA present in the environment, and humans routinely consume
DNA as a component of food.
    All humans are exposed to DNA throughout their lives as part of
their diet, in which DNA is metabolized to its component nucleic acids,
which are then further used by the body for essential metabolic
processes. Consumption of nucleic acids in food has not been associated
with any toxic effects. Thus, because the DNA sequences that are used
as product identifier contain the same nucleic acids, (adenine,
cytosine, guanine and thymine) as found in DNA, consumption of food
containing residues of DNA sequences that are used as product
identifiers are not expected to present a toxic effect.
    There is a potential for extracellular or exogenous DNA to interact
with microorganisms in the environment such as bacteria. This
interaction could result in the formation of exogenous proteins or
other materials that could potentially be harmful to humans. However,
the DNA sequences proposed for use by the petitioner lack start codons
or regulatory sequences necessary for the initiation of transcription
or translation. They cannot encode a protein nor integrate with other
genetic sequences and, as such, cannot lead to the formation of
exogenous proteins or other materials. Moreover, the restriction of
exempted DNA to be comprised of 300 base pairs or less will also limit
the ability of DNA to replicate in the environment. Finally, the DNA
sequence's ability to cause replication are further limited by lack of
stability and integrity of extracellular DNA in the environment.
Extracellular DNA routinely degrades in the environment when it is
exposed to harsh environmental conditions such as mechanical shearing
and UV degradation.

B. Toxicological Points of Departure/Levels of Concern

    As no human health toxicity endpoints have been selected, a
quantitative assessment is not being conducted.

C. Exposure Assessment

    All humans are exposed to DNA throughout their lives as part of
diet. As an inert ingredient in pesticide products, DNA sequences may
result in residues in or on food. DNA sequences may be used as an inert
ingredient (product identifiers) in pesticide formulations that are
used in residential setting, however because DNA sequences are unlikely
to cross the skin barrier or be available via inhalation. Therefore,
inhalation and dermal exposure are not of concern.
    Due to the lack of toxicity, EPA does not expect these exposures to
pose any risk of harm. DNA sequences used as product identifiers will
also be limited to 1 ppm in pesticide formulations, with any resultant
exposure to humans resulting from such use being negligible.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold (10X) 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 on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA Safety Factor (SF). In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    Due to the lack of toxicity or any threshold effects, an FQPA SF is
not needed to protect the safety of infants and children.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on
deoxyribonucleic acid sequences consisting solely of adenine, cytosine,
guanine and thymine, of 300 or fewer base pairs, and which do not
contain start codons or regulatory sequences necessary for the
initiation of transcription or translation when used as an inert
ingredient (product identifier), EPA has determined that there is a
reasonable certainty that no harm to any population subgroup will
result from aggregate exposure to deoxyribonucleic acid sequences under
reasonably foreseeable circumstances. Therefore, the establishment of
an exemption from tolerance under 40 CFR 180.910 for residues of
deoxyribonucleic acid sequences as described in the exemption when used
as an inert ingredient in pesticide formulations applied to growing
crops and to raw agricultural commodities after harvest at a
concentration not to exceed 1.0 ppm, 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
DNA sequences in or on any food commodities. EPA is establishing
limitations on the amount of DNA sequences that may be used in
pesticide formulations applied pre- and post-harvest. These limitations
will be enforced through the pesticide registration process under the
Federal Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), 7
U.S.C. 136 et seq. EPA will not register any pesticide formulation for
food use that exceeds 1 ppm by weight of DNA sequences in the final
pesticide formulation.

B. Response to Comments

    One comment generally asserting that pesticides are toxic and
should not be allowed on food was received in response to the notice of
filing. Although the Agency recognizes that some individuals believe
that pesticides should be banned on agricultural crops, the existing
legal framework provided by section 408 of the Federal Food, Drug and
Cosmetic Act (FFDCA) authorizes EPA to establish tolerances when it
determines that the tolerance is safe. Upon consideration of the
validity, completeness, and reliability of the available data as well
as other factors the FFDCA requires EPA to consider, EPA has determined
that this exemption is safe. The commenter has provided no information
to indicate that the exemption would not be safe.

C. Revisions to Petitioned-for Tolerances

    Based on clarification as to the composition of the DNA that would
be utilized as a product identifier, the petitioner provided additional
descriptive criteria that have been incorporated by the Agency into the
tolerance exemption expression to ensure that the DNA sequences used as
product identifiers would not be taken up by organisms in the
environment and

used for the production of proteins that could be harmful to human
health.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for deoxyribonucleic acid sequences
consisting solely of adenine, cytosine, guanine and thymine, of 300 or
fewer base pairs, and which do not contain start codons or regulatory
sequences necessary for the initiation of transcription or translation
when used as an inert ingredient (product identifier) in pesticide
formulations applied to growing crops and to raw agricultural
commodities after harvest at a concentration not to exceed 1.0 ppm.

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), nor is it considered a regulatory action under
Executive Order 13771, entitled ``Reducing Regulations and Controlling
Regulatory Costs'' (82 FR 9339, February 3, 2017). This action does not
contain any information collections subject to OMB approval under the
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it
require any special considerations under Executive Order 12898,
entitled ``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the National Government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

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: August 27, 2020.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended 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.  180.910, add alphabetically the inert ingredient
``Deoxyribonucleic acid (DNA) sequences consisting solely of adenine,
cytosine, guanine and thymine, of 300 or fewer base pairs, and which do
not contain start codons or regulatory sequences necessary for the
initiation of transcription or translation'' to Table 1 to read as
follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

                           Table 1 to 180.910
------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------

                              * * * * * * *
Deoxyribonucleic acid (DNA)       No more than 1 ppm  Product
 sequences consisting solely of    in pesticide        identifier.
 adenine, cytosine, guanine and    formulation.
 thymine, of 300 or fewer base
 pairs, and which do not contain
 start codons or regulatory
 sequences necessary for the
 initiation of transcription or
 translation.

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

[FR Doc. 2020-19491 Filed 9-2-20; 8:45 am]
BILLING CODE 6560-50-P