[Federal Register: November 18, 2009 (Volume 74, Number 221)]
[Notices]
[Page 59599-59601]
[DOCID:fr18no09-104]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60984; File No. SR-NYSEAmex-2009-57]

Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a
Proposed Rule Change, as Modified by Amendment No. 1, Amending Rule
36--NYSE Amex Equities To Conform With Proposed Amendments to
Corresponding NYSE Rule 36 To Permit the Use of Personal Portable or
Wireless Communication Devices Off the Exchange Trading Floor and
Outside Other Restricted Access Areas

November 10, 2009.

I. Introduction

    On August 27, 2009, NYSE Amex LLC (``NYSE Amex'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of 1934
(the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ a proposed rule change,
as modified by Amendment No. 1,\4\ to amend Rule 36--NYSE Amex Equities
to permit the use of personal portable or wireless communication
devices off the Exchange Trading Floor and outside other restricted
access areas, and to make corresponding technical changes. The proposed
rule change was published for comment in the Federal Register on
September 28, 2009.\5\ The Commission received no comments regarding
the proposal. This order approves the proposed rule change.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
    \4\ Amendment No. 1, which the Exchange filed on September 17,
2009, superseded and replaced the original filing in its entirety.
    \5\ See Securities Exchange Act Release No. 60692 (September 18,
2009), 74 FR 49428 (``Notice'').
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II. Background

    Currently, Rule 36--NYSE Amex Equities prohibits members and member
organizations from establishing or maintaining any telephonic or
electronic communication, including the usage of any portable or
wireless communication devices (i.e. cellular phone, wireless pager,
BlackBerry\TM\, etc.), between the Floor, as defined in Rule 6--NYSE
Amex Equities, and any other location without prior Exchange approval.
    Notwithstanding the general prohibition on the use of portable or
wireless communication devices, current Rule 36--NYSE Amex Equities
permits Floor brokers to use Exchange authorized and issued portable
phones on the Floor to communicate with both member firms and non-
members off the Floor, subject to certain restrictions.\6\ Floor
brokers may not, however, use Exchange authorized and issued devices on
the NYSE Amex Options Trading Floor (as defined in Rule 6A--NYSE Amex
Equities).\7\ In addition, current Rule 36--NYSE Amex Equities permits
Designated Market Makers (``DMMs''), subject to restriction, to
maintain at their posts telephone lines to the off-Floor offices of the
DMM unit or the unit's clearing firm.\8\ Such telephone lines may only
be used to enter options or futures hedging orders through the DMM
unit's off-Floor office or the unit's clearing firm, or through a
member (on the Floor) of an options or futures exchange. These lines
may not, however, be used for the purpose of transmitting to the Floor
orders for the purchase or sale of securities. DMMs are also permitted
to use at their posts wired or wireless devices, including computer
terminals or laptops, that are registered with the Exchange to
communicate with their system algorithms.\9\ Under Rule 36--NYSE Amex
Equities, the use of all other portable or wireless communication
devices on the Floor is prohibited.
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    \6\ All members and member firm employees who use an Exchange
authorized and issued portable phone must execute a written
acknowledgement as to the usage of the phone and authorizing the
Exchange to receive data and records related to incoming and
outgoing calls. See NYSE Information Memos 08-40 (August 14, 2008)
and 08-41 (August 14, 2008) (concerning the use of Exchange
authorized and issued portable phones on the Floor, incorporated by
reference in joint NYSE/NYSE Amex Information Memo 08-66 (December
22, 2008)).
    \7\ See Rule 36--NYSE Amex Equities, Supplementary Material
.20--.23
    \8\ The role of DMMs and their obligations on the Exchange
adopted pursuant to the merger of the Exchange with the New York
Stock Exchange are described in Securities Exchange Act Release No.
58845 (October 24, 2008), 73 FR 64379 (October 29, 2008) (SR-NYSE-
2008-46). See also Securities Exchange Act Release No. 59022
(November 26, 2008), 73 FR 73683 (December 3, 2008) (SR-NYSEALTR-
2008-10). Notably, pursuant to these releases, the Exchange phased
out the specialist system and adopted a Designated Market Maker
(``DMM'') structure.
    \9\ See Rule 36.30--NYSE Amex Equities.
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    As noted in the foregoing paragraph, the restrictions on the use of
portable or wireless communication devices in current Rule 36--NYSE
Amex Equities relate to what is and is not permissible on the Exchange
Floor. Under Rule 6--NYSE Amex Equities, the term ``Floor'' is defined
as having the same meaning given that term ``under the Act.'' The
Exchange has issued interpretive guidance that the ``Floor'' includes
the trading Floor of the Exchange and the premises immediately adjacent
thereto, such as the various entrances and lobbies of the 11 Wall
Street, 18 New Street, 8 Broad Street, 12 Broad Street and 18 Broad
Street Buildings, the telephone facilities available in these
locations, the areas outside the ``Blue Line'' (member and member
organization booths adjacent to the trading Floor), and any area
reserved primarily for members, including members' lounges and
bathrooms.\10\
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    \10\ See NYSE/NYSE Amex Information Memo 08-66 (December 22,
2008).
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    Recently, the Exchange adopted Rule 6A--NYSE Amex Equities, setting
forth a definition of ``Trading Floor'' that is distinct from the
definition of Floor. Specifically, the Equities Trading Floor is an
area within the area of the ``Floor'' and defined as ``the restricted-
access physical areas designated by the Exchange for the trading of
securities, commonly known as the `Main Room' and the `Garage.''' As
such, the Trading Floor's restricted access physical areas include the
areas outside the Blue Line that include the member and member
organization booths and/or trading desks. In accordance with Rule 6A--
NYSE Amex Equities, the Equities Trading Floor does not, however,
include the areas where NYSE Amex-listed options are traded, commonly
known as the ``Blue Room'' and the ``Extended Blue Room'' (the ``NYSE
Amex Options Trading Floor'').\11\
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    \11\ In the filing, the Exchange noted that the NYSE Amex
Options Trading Floor is within the restricted access perimeter that
encompasses the NYSE and NYSE Amex Equities Trading Floors and thus
member and member firm employees would not be permitted to use such
devices in that space under the terms of the proposal. In addition,
while the Exchange's Options Rules permit NYSE Amex Options members
to use personal communications devices on the NYSE Amex Options
Trading Floor, those rules prohibit NYSE Amex Options members from
using those devices on the Equities Trading Floor of the Exchange.
See NYSE Amex Options Rule 902NY. In addition, pursuant to the
definitions of ``Floor'' and ``Trading Floor'' in Rules 6 and 6A--
NYSE Amex Equities, and corresponding NYSE Rules 6 and 6A, the NYSE
Amex Equities and NYSE Trading Floors overlap and thus references to
the NYSE Amex ``Equities Trading Floor'' include the NYSE Trading
Floor. See Securities Exchange Act Release No. 59480 (March 2,
2009), 74 FR 10109 (March 9, 2009) (SR-NYSEALTR-2009-21) (adopting
Rule 6A--NYSE Amex Equities.)

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III. Description of the Proposal

    The Exchange proposes to amend Rule 36--NYSE Amex Equities to
conform with proposed amendments to corresponding New York Stock
Exchange (``NYSE'') Rule 36.\12\ The proposed amendments to Rule 36--
NYSE Amex Equities would permit the use of personal portable or
wireless communication devices outside of the Exchange's Trading Floor
and other restricted access areas, provided such usage is consistent
with all other Exchange Rules and federal securities laws and rules
thereunder. Floor brokers would still be limited to using only Exchange
authorized and issued portable phones on the Exchange Trading Floor and
DMMs would still only be permitted to use registered telephone lines
and/or wired or wireless devices at their posts, and all such devices
and communications would continue to be regulated by the Exchange.
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    \12\ See Securities Exchange Act Release No. 60691 (September
18, 2009), 74 FR 49431 (September 28, 2009) (SR-NYSE-2009-84). As
more fully explained in the Notice, NYSE Amex Equities Rules, are
substantially identical to NYSE Rules 1-1004.
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    The proposal would permit members and member firm employees to use
personal portable or wireless communications devices in designated
areas of the Exchange's buildings and facilities that fall within the
technical definition of the Floor under Rule 6, but that are outside
the Trading Floor, and other restricted access points (i.e., where
there are turnstiles or card swipe pads that electronically release
locked doors to permit authorized entry).\13\ Because the lobby and
other corridor areas where usage of personal portable or wireless
communications devices will now be permitted still fall within the
broader definition of ``Floor'' under Exchange rules, the Exchange will
retain jurisdiction over its members in these areas. As such, in its
filing, the Exchange noted that it would retain jurisdiction over its
members and member firm employees to regulate conduct that is
inconsistent with Exchange Rules and/or federal securities laws (e.g.,
trading ahead, insider trading, market manipulation).\14\
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    \13\ In the filing, the Exchange represented that the majority
of the doors that require card swipe for entry are opaque. See also
note 20 infra.
    \14\ See Notice, supra note 5.
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    The proposal would thus permit members and member firm employees to
use their personal communications devices in the in the hallways,
stairwells, lobbies or members-only areas of the Exchange premises that
are adjacent to the Equities and Options Trading Floors of the Exchange
and the NYSE.\15\ The Exchange stated specifically that such usage
would be permitted in the lobby areas of the Exchange's facilities at
11 Wall Street, 6 and 18 New Street, and 2, 12, 18 and 20 Broad Street,
as well as in the corridor in front of the interior elevator bank
inside of 18 Broad Street.\16\
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    \15\ It is important to note that the NYSE Amex Options Trading
Floor is within the restricted access perimeter that encompasses the
NYSE and NYSE Amex Equities Trading Floors and thus member and
member firm employees would not be permitted to use such devices in
that space under the terms of the proposed Rule defining where such
devices are permissible. See proposed Rule 36.23--NYSE Amex
Equities. In addition, while the Exchange's Options Rules permit
NYSE Amex Options members to use personal communications devices on
the NYSE Amex Options Trading Floor, those rules prohibit NYSE Amex
Options members from using those devices on the Equities Trading
Floor of the Exchange. See NYSE Amex Options Rule 902NY.
    \16\ See Notice, supra note 5.
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    In its filing, the Exchange stated that the purpose of the proposal
is to provide Exchange members and member firm employees with a
reasonable and comfortable space inside the physical confines of the
Exchange's buildings and facilities within which they may use their
personal portable or wireless communication devices, without
diminishing the ability to monitor and regulate their conduct.\17\
According to the Exchange, the current prohibitions of Rule 36--NYSE
Amex Equities and the broad definition of ``Floor'' under Rule 6--NYSE
Amex Equities together effectively require members and member firm
employees to exit the Exchange premises in order to use their personal
portable or wireless communications devices.\18\ In the Exchange's
view, the distance afforded by allowing a DMM, for example, to use a
personal portable or wireless communication device outside the
turnstiles is, in essence, equivalent to requiring a DMM to leave the
Exchange's premises to do the same.\19\ Further, the Exchange
represented that any time or place advantage to using such devices
outside restricted access areas is significantly reduced by the fact
that a DMM has no line of sight \20\ and no ability to hear trading
activity on the Floor and the speed of electronic trading would likely
render stale any information a DMM had prior to leaving his or her post
on the Trading Floor.\21\
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    \17\ See Notice, supra note 5.
    \18\ See Notice, supra note 5. In the filing, the Exchange
acknowledged that there are other areas on the Exchange's premises
where personal communications devices may be used by members and
member firm employees (e.g., the cafeteria in 11 Wall Street), but
represented that these areas are either too far from the Trading
Floor to be practical or do not have adequate reception for such
devices.
    \19\ See Notice, supra note 5.
    \20\ The Commission notes that in at least one lobby area there
is a line of sight to the Trading Floor and a trading post, unlike
other lobby areas where the doors to the Trading Floor are opaque.
See supra note 13. The Commission acknowledges, however, that it
would be difficult to see any specific information on the post
screens from this lobby area. The Commission expects the Exchange to
monitor this to ensure that this remains the case and that such line
of sight to the Trading Floor is not misused.
    \21\ See Notice, supra note 5.
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    In addition, noting that the proposed rule amendments specifically
provide that the use of personal portable or wireless communication
devices by Exchange members and member firm employees is subject to
compliance with all other Exchange Rules and/or federal securities
laws, the Exchange represented that it will issue a Notice to Members
that will, among other things, remind Exchange members and member firm
employees of their obligations under the requirements of Securities
Exchange Act Release Nos. 33-7288 and 34-37182, concerning the ``Use of
Electronic Media by Broker-Dealers, Transfer Agents, and Investment
Advisers for Delivery of Information.'' \22\
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    \22\ See Securities Exchange Act Release Nos. 33-7288 and 34-
37182 (May 9, 1996), 61 FR 24643 (May 15, 1996) (S7-13-96). See also
FINRA Regulatory Notice 2007-59 (December 7, 2007), concerning the
supervision of electronic communications.
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    The Exchange also proposed to change Rule 36.23--NYSE Amex Equities
to refer to NYSE Amex Options Rule 902NY to clarify that the Exchange's
Options Rules permit NYSE Amex Options members to use personal
communications devices on the NYSE Amex Options Trading Floor, but that
such rule prohibits NYSE Amex Options members from using those devices
on the Equities Trading Floor of the Exchange. The Exchange also
proposed corresponding technical amendments to Rule 36.20--NYSE Amex
Equities.

IV. Discussion

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities exchange.
Specifically, the Commission finds that the proposed rule change is
consistent with Section 6(b)(5) of the Act,\23\ which requires, among
other things, that the rules of a national securities exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to remove impediments
to, and perfect the mechanism of, a free and

open market and a national market system, and in general, to protect
investors and the public interest.\24\
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    \23\ 15 U.S.C. 78f(b)(5).
    \24\ In approving this proposed rule change, 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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    The Exchange has proposed that members and member firm employees be
permitted to use personal portable or wireless communication devices
off the Exchange Trading Floor and outside of restricted access areas
(i.e. restricted access areas are areas where there are turnstiles or
card swipe pads that electronically release locked doors to permit
authorized entry),\25\ subject to compliance with all other Exchange
Rules and the federal securities laws and rules thereunder. The
proposal marks a departure from the Exchange's current prohibition on
the use of such devices in areas that are in close proximity to the
Trading Floor of the Exchange, and its stated policy that ``best
practice'' is for ``personal contacts made using portable communication
devices, whether Exchange issued or not, [to] be made outside the
building.'' \26\
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    \25\ As noted above, restricted access areas include the areas
outside the Blue Line that include member and member organization
booths and/or trading desks.
    \26\ See NYSE/NYSE Amex Information Memo 08-66 (December 22,
2008).
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    The Commission finds, however, that the proposal strikes a
reasonable balance between the Exchange's interest in providing a
convenient and comfortable space for Exchange members and member firm
employees to use their personal portable communications devices inside
Exchange buildings and its interest in minimizing the risk of misuse of
such devices, which are not subject to the same surveillance as
Exchange authorized and issued devices. In particular, the Commission
notes the Exchange's representation that any time or place advantage to
using personal portable communication devices outside restricted points
of access to the Trading Floor is ``significantly reduced by the fact
that a Floor Broker or DMM has no line of sight and no ability to hear
trading activity on the [Trading] Floor and the speed of electronic
trading would likely render stale any information a DMM had prior to
leaving his or her post on the Trading Floor.'' \27\ As noted above,
the Commission expects that the Exchange will, in the exercise of its
regulatory responsibilities, work to ensure that any line of sight to
the Trading Floor that may exist does not allow access to Trading Floor
information that may raise concerns.\28\
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    \27\ See Notice, supra note 5.
    \28\ See supra note 20.
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    The Commission notes that the Exchange retains jurisdiction over
its members for their conduct in the new areas where the use of
personal communication devices will now be permitted because these
areas are still within the broader definition of Floor under Rule 6--
NYSE Amex Equities.\29\ The Commission further notes the Exchange's
representation that it will issue a Notice to Members reminding members
of their obligations under Securities Exchange Act Release Nos. 33-7288
and 34-37182, concerning the ``Use of Electronic Media by Broker-
Dealers, Transfer Agents, and Investment Advisers for Delivery of
Information.'' \30\ In these releases, among other things, the
Commission noted that the substantive and liability provisions of the
federal securities laws, as well as the recordkeeping requirements of
the Act apply equally to electronic and paper based media.\31\
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    \29\ See note 14 and accompanying text supra.
    \30\ See Securities Act Release No 7288 and Securities Exchange
Act Release No. 37182 (May 9, 1996), 61 FR 24643 (May 15, 1996) (S7-
13-96).
    \31\ Id. See also FINRA Regulatory Notice 2007-59 (December 7,
2007), concerning the supervision of electronic communications,
which among other things, reminds member firms of their obligation
to (1) have supervisory policies and procedures to monitor all
electronic communications technology used by the firm and its
associated persons to conduct the firm's business; and (2) ensure
that their use of electronic communications media enables them to
make and keep records, as required by Commission and Exchange rules
(e.g., Rules 17a-3 and 17a-4 under the Act and Rule 440--NYSE Amex
Equities).
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    The Commission further finds that the added reference in Rule 36.23
to NYSE Amex Options Rule 902NY is consistent with the Act because it
ensures that Rule 36.23 references a rule that clarifies members'
obligations. The Commission also finds the proposed technical changes
to Rules 36.20 to be consistent with the Act.
    Based on the foregoing, the Commission therefore finds the proposal
to be consistent with the Act. The Commission believes that the
proposal to permit the use of personal communication devices in certain
specified areas adjacent to the Exchange's Equities Trading Floor, the
NYSE Amex Options Trading Floor, and the NYSE Trading Floor, while not
without any risk, is tempered by the speed of electronic trading, the
existence of access barriers between such Trading Floors and the areas
where use of personal communication devices will now be permitted, and
the fact that the Exchange retains jurisdiction over its members while
they are in these areas. The Commission expects, however, that the
Exchange will monitor compliance with the new rule and inform the
Commission if it encounters difficulties in implementing and enforcing
it or otherwise finds that that the new rule raises regulatory
concerns.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\32\ that the proposed rule change (SR-NYSEAmex-2009-57), as
amended, be, and hereby is, approved.
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    \32\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\33\
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    \33\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-27609 Filed 11-17-09; 8:45 am]

BILLING CODE 8011-01-P


                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C. 20460

                                                                      OFFICE OF
                                                            CHEMICAL SAFETY AND
                            		POLLUTION PREVENTION

MEMORANDUM

DATE:  	20-AUG-2013

SUBJECT:	Quinoxyfen.  Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for Tolerances for Residues in/on Vegetable, Fruiting, Group 8-10; Fruit, Small Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13-07F; and Berry, Low Growing Subgroup 13-07G.

PC Code:  055459
DP Barcode:  D410693
Decision No.:  471748
Registration No.:  62719-375
Petition No.:  2E8117
Regulatory Action:  Sec. 3 Registration
Risk Assessment Type:  Dietary
Case No.:  7037
TXR No.:  NA
CAS No.:  124495-18-7
MRID No.:  NA
40 CFR:  180.588

FROM:	George F. Kramer, Ph.D., Senior Chemist
            Risk Assessment Branch 1 (RAB1)/Health Effects Division (HED; 7509P)

THROUGH:	David E. Hrdy, Senior Biologist
            Seyed Tadayon, Chemist
            Dietary Exposure Science Advisory Council (DESAC)
            HED (7509P)

                  and

		Dana M. Vogel, Acting Branch Chief, RAB1
		Associate Division Director, HED (7509P)

TO:		George F. Kramer, Ph.D., Risk Assessor
		RAB1/HED (7509P)

            and

      Barbara Madden/Sidney Jackson, RM 05
      Registration Division (RD) (7505P)

Executive Summary

A chronic dietary-exposure and risk assessment was conducted using the Dietary Exposure Evaluation Model - Food Consumption Intake Database (DEEM-FCID, ver. 3.16) which incorporates consumption data from United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA; 2003-2008).  This analysis was performed to support a proposed Section 3 Registration for application of quinoxyfen to vegetable, fruiting, group 8-10; fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F; and berry, low growing subgroup 13-07G.  This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC SOP 2012.1.

Acute Dietary (Food and Drinking Water) Exposure Results and Characterization

No toxic effects attributable to a single (i.e., acute) exposure to quinoxyfen have been identified; therefore, an acute population-adjusted dose (aPAD) has not been established for quinoxyfen and an acute dietary exposure assessment has not been conducted.

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization

The unrefined chronic analysis assumed 100% crop treated (CT), DEEM 7.81 default concentration factors, and tolerance-level residues for all commodities.  The drinking water estimate from the existing U.S. uses was incorporated directly into the dietary assessment using the concentration for surface water generated by the FQPA Index Reservoir Screening Tool (FIRST) model.  The chronic dietary risk estimates (food + water) were 2.4% of the chronic population-adjusted dose (cPAD) for the general U.S. population and 8.5% of the cPAD for the most highly exposed population subgroup (children 1-2 years old) and are thus below HED's level of concern (>100% cPAD).

Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization

Quinoxyfen is classified as "not likely carcinogenic to humans."  Therefore, cancer risk is not a concern for this chemical.

I.  Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the PAD.  The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, i.e.) divided by the required uncertainty and/or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  HED is generally concerned when estimated cancer risk exceeds one in one million.  References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  "Available Information on Assessing Exposure from Pesticides, A User's Guide," 21-JUN-2000, web link:  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf; or see SOP 99.6 (20-AUG-1999).

The most recent dietary exposure risk assessment for quinoxyfen was conducted by W. Carr (Memo, 02-DEC-2008, D354561).

II.  Residue Information

Quinoxyfen Proposed and Registered Uses:

There is currently one quinoxyfen end-use product (EP) registered to Dow Agrosciences LLC for use on food/feed crops:  Quintec[(R)], a 22.58% ai SC (EPA Reg. No. 62719-375).  The Interregional Project No. 4 (IR-4) has proposed a Section 3 Registration for application of quinoxyfen to vegetable, fruiting, group 8-10; fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F; and berry, low growing subgroup 13-07G.

Residues of Concern:  Based on acceptable cucumber, grape, sugar beet, and tomato metabolism studies, the nature of the residue in plants is adequately understood in the subject crops.  The HED Metabolism Assessment Review Committee (MARC) has determined that the residue of concern for purposes of tolerance enforcement and risk assessment is the parent compound only.

Established Tolerances:  Permanent tolerances are established for residues of quinoxyfen per se [40 CFR §180. 588 (a)] in/on cherries (0.30 ppm); grapes (0.60 ppm); hop, dried cones (3.0 ppm); lettuce, head (7.0 ppm); lettuce, leaf (19 ppm); pepper, bell (0.35 ppm); pepper, non-bell (1.7 ppm); strawberry (0.90 ppm); pumpkin (0.30 ppm); squash, winter (0.30 ppm); and melon subgroup 9A (0.08 ppm).

Recommended Tolerances:  Based on the residue chemistry data submitted with the current petition, HED recommended for establishment of the following tolerances (G. Kramer, 20-AUG-2013; D407728):

Table 1.  Tolerance Summary for Quinoxyfen.
Commodity
                           Proposed Tolerance (ppm)
                        HED-Recommended Tolerance (ppm)
Correct Commodity Definition/Comments
Vegetable, fruiting, group 8-10
                                      1.7
                                      1.7

Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F
                                     0.60
                                      2.0

Berry, low growing, subgroup 13-07G
                                     0.90
                                      1.0

Remove from 40 CFR §180.588 (a):
Grape

Pepper, bell

Pepper, nonbell

Strawberry

Residue Data used for Acute and Chronic Assessments:

The unrefined chronic analysis assumed tolerance-level residues for all commodities.

Processing Factors:  DEEM 7.81 default processing factors were used for all processed commodities (where provided).

Fish:  The USDA Pesticide Data Program (PDP) monitored pesticide residues in catfish in 2008, 2009, and 2010.  Over this three-year period, PDP analyzed 552 samples of catfish for quinoxyfen residues.  None of the samples contained detectable residues.  As a result, residues in fish were not included in the assessment.

III.  Percent Crop Treated Information

The chronic assessment is based on the assumption of 100% CT for all commodities.

IV.  Drinking Water Data

The Estimated Drinking Water Concentrations (EDWCs) used in the dietary exposure risk assessment were provided by the Environmental Fate and Effects Division (EFED) in a memorandum dated 4/23/13 (Memo, K. Milians; DP# 407730).  Water residues were incorporated directly into the DEEM-FCID into the food categories "water, direct, all sources" and "water, indirect, all sources."

Screening EDWCs (Table 2) for quinoxyfen were generated with were estimated using the FIRST model for surface water and the Screening Concentration in Ground Water (SCI-GROW) model for groundwater.  EDWCs were determined based on an annual application rate of 0.57 lb a.i./A (five applications at 0.114 lb a.i./A, with a re-application interval of seven days), and an annual application rate of 0.52 lb a.i./A (four applications at 0.13 lb a.i./A, with a re-application interval of six days).  Table 2 lists the EDWCs for surface water and ground water recommended for use in dietary risk assessment.  These EDWCs represent concentrations of quinoxyfen plus its degradate 3-OH quinoxyfen.

Table 2.  Tiered EDWCs for Proposed Quinoxyfen Uses.

Source (Tier:  Model)
                       1-in-10-year Peak Exposure (ppb)
                    1-in-10-year Annual Mean Exposure (ppb)
Surface water (Tier I:  FIRST)
                                      9.9
                                     0.66
                          (used in chronic analysis)
Ground water (Tier I:  SCI-GROW)
                                 3.4 x 10[-3]
                                 3.4 x 10[-3]

V.  DEEM-FCID Program and Consumption Information

A quinoxyfen chronic dietary exposure assessment was conducted using the DEEM-FCID model, Version 3.16, which incorporates 2003-2008 consumption data from USDA's NHANES/WWEIA.  The data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods "as consumed" (e.g., apple pie) are linked to EPA-defined food commodities (e.g., apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups.  Based on analysis of the 2003-2008 WWEIA consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50-99 years old.

For a chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

VI.  Toxicological Information

Table 3.  Summary of Toxicological Doses and Endpoints for Quinoxyfen for Use in Dietary Human-Health Risk Assessments
                              Exposure/ Scenario
                                      POD
                                 Uncertainty/
                                   FQPA SFs
                RfD, PAD, Level of Concern for Risk Assessment
                        Study and Toxicological Effects
                                 Acute Dietary
                               (All Populations)
                                Not applicable
                                Not applicable
                                Not applicable
No adverse effects attributable to a single dose were observed.  As a result, no hazard was identified and an endpoint was not selected to assess this exposure scenario.
Chronic Dietary (All Populations)
NOAEL=
20 mg/kg/day
UFA = 10X

UFH = 10X

FQPA SF= 1X
Chronic RfD = 0.2 mg/kg/day

cPAD = 0.2 mg/kg/day
Combined Chronic Toxicity/Carcinogenicity (rats)

LOAEL = 80 mg/kg/day based on increases in severity of chronic progressive glomerulonephropathy in the males and decreases in body weight and body-weight gain in both sexes.
Cancer (oral, dermal, inhalation)
Classified as "not likely to be carcinogenic to humans" based on the absence of carcinogenicity in rats or mice
Point of departure (POD) = A data point or an estimated point that is derived from observed dose-response data and  used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no-observed adverse-effect level.  LOAEL = lowest-observed adverse-effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  FQPA SF = FQPA Safety Factor.  PAD = population-adjusted dose (a = acute, c = chronic).  RfD = reference dose.  LOC = level of concern.

VII.  Results/Discussion

For a chronic assessment, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Table 5 are for the general U.S. population, all infants (<1 year old), children 1-2 years old, children 3-5 years old, children 6-12 years old, youth 13-19 years old, females 13-49 years old, adults 20-49 years old, and adults 50+ years old.

Results of Chronic Dietary Exposure Analysis

The chronic dietary risk for food and drinking water utilized 3.3% of the cPAD for the U.S. population.  The chronic dietary risk for the highest exposed population subgroup, children 1-2 years old, is 8.5% of the cPAD.

The results of the chronic dietary exposure analysis is reported in Table 4.

 Table 4.  Summary of Dietary (Food and Drinking Water) Exposure Risk for Quinoxyfen.
                              Population Subgroup
                       Acute Dietary (95[th] Percentile)
                                Chronic Dietary

                          Dietary Exposure (mg/kg/day)
                                     % aPAD
                                Dietary Exposure
                                  (mg/kg/day)
                                     % cPAD
 General U.S. Population
                                      N/A
                                      N/A
                                    0.006582
                                      3.3
 All Infants (<1 year old)
                                      N/A
                                      N/A
                                    0.005601
                                      2.8
 Children 1-2 years old
                                      N/A
                                      N/A
                                    0.016903
                                      8.5
 Children 3-5 years old
                                      N/A
                                      N/A
                                    0.014353
                                      7.2
 Children 6-12 years old
                                      N/A
                                      N/A
                                    0.007967
                                      4.0
 Youth 13-19 years old
                                      N/A
                                      N/A
                                    0.005047
                                      2.5
 Adults 20-49 years old
                                      N/A
                                      N/A
                                    0.005882
                                      2.9
 Adults 50-99 years old
                                      N/A
                                      N/A
                                    0.005669
                                      2.8
 Females 13-49 years old
                                      N/A
                                      N/A
                                    0.005907
                                      3.0
 *The values for the highest exposed population for each type of risk assessment are bolded.

 VIII.  Characterization of Inputs/Outputs

This chronic dietary exposure and risk estimate is conservative since it assumed 100% CT, DEEM 7.81 default concentration factors, and tolerance-level and were based on screening level estimates of drinking water concentrations generated by the FIRST model.  They could be further refined through the use of anticipated residues, empirical processing factors and % CT data, as well as refined drinking water estimates.

 IX.  Conclusions

The chronic dietary exposure and risk analysis using DEEM-FCID indicates that dietary risks to quinoxyfen from food and drinking water are well below HED's levels of concern for this pesticide.  Estimated chronic dietary risks are <=8.5% of the cPAD for the general U.S. population and all population subgroups.  HED is confident that the assessment does not underestimate risk to the general U.S. population or any population subgroup.

 X.  List of Attachments

 Chronic Food plus Water Residue Input File.
 Chronic Results File.

cc:  G. Kramer (RAB1)
RDI:  DESAC (5/8/13)
G.F. Kramer:S10957:PY-S:(703)305-5079:7509P:RAB1

Chronic Food plus Water Residue Input File.

Filename: C:\Documents and Settings\gkramer\My Documents\Gk\##Quinoxyfen\QUINOXYFEN.R08
Chemical: Qunioxyfen
RfD(Chronic): .2 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day
RfD(Acute): 0 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day
Date created/last modified: 05-09-2013/13:21:01       Program ver. 3.16, 03-08-d
Comment: Chronic dietary assessment to support new uses on lettuce, strawberry, pepper & melons.
-----------------------------------------------------------------------------------
   EPA     Crop                                   Def Res     Adj.Factors   Comment
   Code     Grp  Commodity Name                    (ppm)       #1    #2
---------- ---- -------------------------------  ----------  ------ ------  -------
0401204000 4A   Lettuce, head                      7.000000   1.000  1.000
0401205000 4A   Lettuce, leaf                     19.000000   1.000  1.000
0801374000 8A   Tomatillo                          1.700000   1.000  1.000
0801375000 8A   Tomato                             1.700000   1.000  1.000
0801375001 8A   Tomato-babyfood                    1.700000   1.000  1.000
0801376000 8A   Tomato, paste                      1.700000   5.400  1.000
0801376001 8A   Tomato, paste-babyfood             1.700000   5.400  1.000
0801377000 8A   Tomato, puree                      1.700000   3.300  1.000
0801377001 8A   Tomato, puree-babyfood             1.700000   3.300  1.000
0801378000 8A   Tomato, dried                      1.700000  14.300  1.000
0801378001 8A   Tomato, dried-babyfood             1.700000  14.300  1.000
0801379000 8A   Tomato, juice                      1.700000   1.500  1.000
0801380000 8A   Tomato, Tree                       1.700000   1.000  1.000
0802148000 8BC  Eggplant                           1.700000   1.000  1.000
0802234000 8BC  Okra                               1.700000   1.000  1.000
0802270000 8B   Pepper, bell                       1.700000   1.000  1.000
0802270001 8B   Pepper, bell-babyfood              1.700000   1.000  1.000
0802271000 8B   Pepper, bell, dried                1.700000   1.000  1.000
0802271001 8B   Pepper, bell, dried-babyfood       1.700000   1.000  1.000
0802272000 8BC  Pepper, nonbell                    1.700000   1.000  1.000
0802272001 8BC  Pepper, nonbell-babyfood           1.700000   1.000  1.000
0802273000 8BC  Pepper, nonbell, dried             1.700000   1.000  1.000
0901075000 9A   Cantaloupe                         0.080000   1.000  1.000
0901187000 9A   Honeydew melon                     0.080000   1.000  1.000
0901399000 9A   Watermelon                         0.080000   1.000  1.000
0901400000 9A   Watermelon, juice                  0.080000   1.000  1.000
0902308000 9B   Pumpkin                            0.200000   1.000  1.000
0902309000 9B   Pumpkin, seed                      0.200000   1.000  1.000
0902357000 9B   Squash, winter                     0.200000   1.000  1.000
0902357001 9B   Squash, winter-babyfood            0.200000   1.000  1.000
1201090000 12A  Cherry                             0.700000   1.000  1.000
1201090001 12A  Cherry-babyfood                    0.700000   1.000  1.000
1201091000 12A  Cherry, juice                      0.700000   1.500  1.000
1201091001 12A  Cherry, juice-babyfood             0.700000   1.500  1.000
1202012000 12B  Apricot                            0.700000   1.000  1.000
1202012001 12B  Apricot-babyfood                   0.700000   1.000  1.000
1202013000 12B  Apricot, dried                     0.700000   6.000  1.000
1202014000 12B  Apricot, juice                     0.700000   1.000  1.000
1202014001 12B  Apricot, juice-babyfood            0.700000   1.000  1.000
1202230000 12B  Nectarine                          0.700000   1.000  1.000
1202260000 12B  Peach                              0.700000   1.000  1.000
1202260001 12B  Peach-babyfood                     0.700000   1.000  1.000
1202261000 12B  Peach, dried                       0.700000   7.000  1.000
1202261001 12B  Peach, dried-babyfood              0.700000   7.000  1.000
1202262000 12B  Peach, juice                       0.700000   1.000  1.000
1202262001 12B  Peach, juice-babyfood              0.700000   1.000  1.000
1203285000 12C  Plum                               0.700000   1.000  1.000
1203285001 12C  Plum-babyfood                      0.700000   1.000  1.000
1203286000 12C  Plum, prune, fresh                 0.700000   1.000  1.000
1203286001 12C  Plum, prune, fresh-babyfood        0.700000   1.000  1.000
1203287000 12C  Plum, prune, dried                 0.700000   5.000  1.000
1203287001 12C  Plum, prune, dried-babyfood        0.700000   5.000  1.000
1203288000 12C  Plum, prune, juice                 0.700000   1.400  1.000
1203288001 12C  Plum, prune, juice-babyfood        0.700000   1.400  1.000
1304175000 13D  Grape                              2.000000   1.000  1.000
1304176000 13D  Grape, juice                       2.000000   1.200  1.000
1304176001 13D  Grape, juice-babyfood              2.000000   1.200  1.000
1304179000 13D  Grape, wine and sherry             2.000000   1.200  1.000
1307130000 13G  Cranberry                          1.000000   1.000  1.000
1307130001 13G  Cranberry-babyfood                 1.000000   1.000  1.000
1307131000 13G  Cranberry, dried                   1.000000   1.000  1.000
1307132000 13G  Cranberry, juice                   1.000000   1.100  1.000
1307132001 13G  Cranberry, juice-babyfood          1.000000   1.100  1.000
1307359000 13G  Strawberry                         1.000000   1.000  1.000
1307359001 13G  Strawberry-babyfood                1.000000   1.000  1.000
1307360000 13G  Strawberry, juice                  1.000000   1.000  1.000
1307360001 13G  Strawberry, juice-babyfood         1.000000   1.000  1.000
8601000000 86A  Water, direct, all sources         0.000660   1.000  1.000  EFED M
            Full comment: EFED Memo of April 23, 2013
8602000000 86B  Water, indirect, all sources       0.000660   1.000  1.000  EFED M
            Full comment: EFED Memo of April 23, 2013
9500016000 O    Artichoke, globe                   1.400000   1.000  1.000
9500177000 O    Grape, leaves                      2.000000   1.000  1.000
9500178000 O    Grape, raisin                      2.000000   4.300  1.000
9500188000 O    Hop                                3.000000   1.000  1.000  Chronic Results File.

EPA                                                             Ver. 3.16, 03-08-d
DEEM-FCID Chronic analysis for QUNIOXYFEN                  NHANES 2003-2008 2-day
Residue file name: C:\Documents and Settings\gkramer\My Documents\Gk\##Quinoxyfen\QUINOXYFEN.R08
                                                     Adjustment factor #2 used.
Analysis Date 05-10-2013/13:03:36     Residue file dated: 05-10-2013/13:03:15
Reference dose (RfD, Chronic) = .2 mg/kg bw/day
COMMENT 1: Chronic dietary assessment to support new uses on lettuce, strawberry, pepper & melons.
===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of
           Subgroup                       body wt/day             Rfd
--------------------------------------   -------------       ----------------
Total US Population                         0.006582                 3.3%
Hispanic                                    0.006634                 3.3%
Non-Hisp-White                              0.006838                 3.4%
Non-Hisp-Black                              0.005438                 2.7%
Non-Hisp-Other                              0.005736                 2.9%
Nursing Infants                             0.002600                 1.3%
Non-Nursing Infants                         0.006942                 3.5%
Female 13+ PREG                             0.005848                 2.9%
Children 1-6                                0.014843                 7.4%
Children 7-12                               0.007292                 3.6%
Male 13-19                                  0.005028                 2.5%
Female 13-19/NP                             0.005066                 2.5%
Male 20+                                    0.005508                 2.8%
Female 20+/NP                               0.006050                 3.0%
Seniors 55+                                 0.005666                 2.8%
All Infants                                 0.005601                 2.8%
Female 13-50                                0.005898                 2.9%
Children 1-2                                0.016903                 8.5%
Children 3-5                                0.014353                 7.2%
Children 6-12                               0.007967                 4.0%
Youth 13-19                                 0.005047                 2.5%
Adults 20-49                                0.005882                 2.9%
Adults 50-99                                0.005669                 2.8%
Female 13-49                                0.005907                 3.0%

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[Federal Register Volume 83, Number 248 (Friday, December 28, 2018)]
[Notices]
[Page 67283]
[FR Doc No: 2018-28293]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2003-0004; FRL-9987-71]

Access to Confidential Business Information by Science
Applications International Corporation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has authorized its contractor Science Applications
International Corporation (SAIC) of Reston, VA, to access information
which has been submitted to EPA under all sections of the Toxic
Substances Control Act (TSCA). Some of the information may be claimed
or determined to be Confidential Business Information (CBI).

DATES: Access to the confidential data occurred on or about November 9,
2018.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Scott M. Sherlock, Environmental
Assistance Division (7408M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of interest to all who manufacture, process, or distribute
industrial chemicals. Since other entities may also be interested, the
Agency has not attempted to describe all the specific entities that may
be affected by this action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPPT-2003-0004, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics
Docket (OPPT Docket), Environmental Protection Agency Docket Center
(EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

II. What action is the Agency taking?

    Under EPA contract number 47QTCK18D0001, order number
47QFPA19F0004, contractor SAIC of 12010 Sunset Hills Rd, Reston, VA is
assisting the Office of Pollution Prevention and Toxics (OPPT) by
providing support of the eChemView and New ChemRev Program; providing
IT support for the development, maintenance and operation of EPA's
Digital Analytics Program (EDAP); geospatial, analytic, and
visualization tools; databases and data management; and application
interfaces and services.
    In accordance with 40 CFR 2.306(j), EPA has determined that under
EPA contract number 47QTCK18D0001, order number 47QFPA19F0004, SAIC
required access to sensitive but unclassified (SBU) information. The
particular SBU that has been accessed is information identified as TSCA
CBI. EPA has determined that SAIC will need access to TSCA CBI
submitted to EPA under all sections of TSCA to perform successfully the
duties specified under the contract. SAIC's personnel were given access
to information claimed or determined to be CBI information submitted to
EPA under all sections of TSCA.
    EPA is issuing this notice to inform all submitters of information
under all sections of TSCA that EPA has provided SAIC access to these
CBI materials on a need-to-know basis only. All access to TSCA CBI
under this contract is taking place at EPA Headquarters, in accordance
with EPA's TSCA CBI Protection Manual.
    Access to TSCA data, including CBI, will continue until October 31,
2019. If the contract is extended, this access will also continue for
the duration of the extended contract without further notice.
    SAIC's personnel have signed nondisclosure agreements and have been
briefed on specific security procedures for TSCA CBI.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: December 12, 2018.
Pamela S. Myrick,
Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2018-28293 Filed 12-27-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 242 (Tuesday, December 18, 2018)]
[Proposed Rules]
[Pages 64752-64757]
[FR Doc No: 2018-27352]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2018-N-3952]

Eliminating Youth Electronic Cigarette and Other Tobacco Product
Use: The Role for Drug Therapies; New Date for Public Hearing; Request
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of new date for public hearing; request for
comments.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing a new date for the public hearing to discuss its efforts to
eliminate youth electronic cigarette (e-cigarette) use as well as other
tobacco product use, with a focus on the potential role of drug
therapies to support youth e-cigarette cessation and the issues
impacting the development of such therapies. FDA is also extending the
comment period.

DATES: The public hearing will be held on January 18, 2019, from 9 a.m.
to 5 p.m. The public hearing may be extended or may end early depending
on the level of public participation. Persons seeking to present at the
public hearing must register by January 8, 2019. Persons seeking to
speak at the public hearing must register by January 15, 2019. Persons
seeking to attend, but not present at, the public hearing must register
by January 15, 2019. Section III provides attendance and registration
information. Electronic or written comments will be accepted after the
public hearing until February 1, 2019.

ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for public hearing
participants (non-FDA employees) is through Building 1, where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before February 1, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 1, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date. You may submit
comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified
as confidential if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-3952 for ``Eliminating Youth Electronic Cigarette and Other
Tobacco Product Use: The Role for Drug Therapies; Public Hearing;
Request for Comments.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9

a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the received electronic and written/paper comments, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Theresa Wells, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 1202, Silver
Spring, MD 20993,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Nearly all tobacco product use begins during youth and young
adulthood (Ref. 1). While the current use of any tobacco product among
U.S. middle and high school students has decreased from 2011 to 2017,
there has been an alarming increase in e-cigarette use over this time.
In fact, since 2014, e-cigarettes \1\ have been the most commonly used
tobacco products among youth, used by 1.73 million (11.7 percent) high
school students and 390,000 (3.3 percent) middle school students in
2017 (Ref. 2). Youth e-cigarette use raises a number of health concerns
including risk of addiction to nicotine early on in life, potential
harm to the developing adolescent brain, and exposure to chemicals
including carbonyl compounds and volatile organic compounds known to
have adverse health effects; the full range of possible health effects
is not yet completely understood (Ref. 3).
---------------------------------------------------------------------------

    \1\ An e-cigarette is one type of electronic nicotine delivery
system, which also includes e-cigars, e-hookah, vape pens, personal
vaporizers, and electronic pipes. See https://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm456610.htm
and Ref. 2.
---------------------------------------------------------------------------

    On April 24, 2018, FDA announced its Youth Tobacco Prevention Plan.
This plan focuses on three key strategies: Prevention of youth access
to tobacco products, curbing the marketing of tobacco products aimed at
youth, and educating teens about the dangers of using any tobacco
products.\2\ FDA recently launched an expansion of its ``The Real
Cost'' campaign to educate youth on the dangers of e-cigarette use \3\
and increased enforcement actions to address this critically important
public health concern.\4\
---------------------------------------------------------------------------

    \2\ https://www.fda.gov/TobaccoProducts/PublicHealthEducation/ProtectingKidsfromTobacco/ucm608433.htm.
    \3\ https://www.fda.gov/tobaccoproducts/publichealtheducation/publiceducationcampaigns/therealcostcampaign/default.htm.
    \4\ https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620788.htm.
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    In addition to the prevention of initiation, which will be the
cornerstone of any successful effort to curb youth e-cigarette use, FDA
is also exploring additional approaches to address youth e-cigarette
use. One such approach may be the development of drug therapies, as
part of multimodal treatment strategies, including behavioral
interventions, to support tobacco product cessation. To date, research
on youth tobacco product cessation has been limited and focused on
smoking (i.e., combustible products) cessation. One recent review found
a paucity of data on either behavioral or drug therapies for smoking
cessation in young people (age less than 20 years) and concluded that
``there continues to be a need for well-designed, adequately powered,
randomized controlled trials of interventions for this population of
smokers'' (Ref. 4). FDA is not aware of any research examining either
drug or behavioral interventions for the cessation of youth or adult e-
cigarette use. In contrast, there is a large body of research on adult
smoking cessation, and multiple drugs for smoking cessation are
approved for the adult population, including a variety of prescription
and over-the-counter nicotine replacement therapy (NRT) products, as
well as the prescription drugs varenicline and bupropion hydrochloride
sustained release (see Appendix A).

II. Purpose and Scope of the Public Hearing

    FDA is holding a public hearing to obtain the public's perspectives
on the potential role drug therapies may play in the broader effort to
eliminate youth e-cigarette and other tobacco product use, as well as
the appropriate methods and study designs for evaluating youth e-
cigarette cessation therapies and the safety and efficacy of such
therapies. The Agency has determined that a public hearing is the most
appropriate way to ensure public engagement on this issue, which is of
great importance to the public health. FDA believes it is critical to
obtain input across the medical and research fields, the pharmaceutical
and tobacco industries, and among public health stakeholders (including
adolescents) regarding approaches to eliminate youth e-cigarette and
other tobacco product use, including exploring whether there is a need
for drug therapies to support youth e-cigarette cessation, and if so,
how FDA can support the development of such therapies.
    Questions for Commenters to Address: Considering the broad range of
activities focused on this public health issue, FDA is interested in
the public's view on approaches to eliminating e-cigarette and other
tobacco product use among youth. Although FDA welcomes all feedback on
any public health, scientific, regulatory, or legal considerations
relating to this topic, we particularly encourage commenters to
consider the following questions as they prepare their comments or
statements. Responses to questions should include supporting scientific
justification.
    1. FDA notes that the factors driving e-cigarette use among youth
likely differ from those in the adult population. How might such
differences impact the need for, or use of, drug therapies for e-
cigarette cessation among youth?
    2. FDA is interested in whether there is a population of youth e-
cigarette users who would be likely to benefit from the use of drug
therapies for e-cigarette cessation. What age groups (older adolescent
vs. younger adolescent), patterns in tobacco use (duration and
frequency of use), and clinical features (level of addiction, presence/
absence of

comorbidities including psychiatric disease) might characterize this
population? What types of products (NRT vs. non-NRT; prescription vs.
over-the-counter) might be useful?
    3. Describe the scientific, clinical, and societal factors that
could either encourage or impede the conduct of clinical trials
designed to evaluate drugs intended for youth e-cigarette cessation.
What approaches could be used to encourage research and overcome
barriers to research?
    4. What methods and study designs are appropriate for assessing
drug therapies for youth e-cigarette cessation? What are the
appropriate control groups? What are the most informative endpoints and
the best assessment tools to evaluate these endpoints?
    5. Acknowledging that to date research has been limited, are there
data available from the adult experience with smoking cessation that
could potentially be leveraged in the effort to develop drug therapies
for youth e-cigarette cessation? Have any drug therapies demonstrated
potential to help adults discontinue e-cigarette use? Are there
differences between adolescents and adults that impact the ability to
extrapolate efficacy findings from the adult population to the
adolescent population? Could existing NRT products be useful for youth
e-cigarette cessation?
    6. While this hearing is focused on the topic of e-cigarette use
among youth, as e-cigarettes are currently the most commonly used form
of tobacco in this population, FDA also welcomes comments regarding the
potential need for drug therapies to support cessation of other tobacco
products, including combustible products (i.e., cigarettes or cigars)
and smokeless tobacco products, among youth and the issues impacting
the development of such therapies.

III. Participating in the Public Hearing

    Registration and Requests for Oral Presentations: The FDA
Conference Center at the White Oak location is a Federal facility with
security procedures and limited seating. Attendance will be free and on
a first-come, first-served basis. For those interested in presenting at
the meeting with a formal oral presentation, please register by January
8, 2019, at https://www.eventbrite.com/e/fda-pediatric-tobacco-cessation-part-15-public-hearing-tickets-50167147288. For those
interested in participating as a speaker during the open public
hearing, please register by January 15, 2019, at https://www.eventbrite.com/e/fda-pediatric-tobacco-cessation-part-15-public-hearing-tickets-50167147288. If you wish to attend either in person or
by webcast (see Streaming Webcast of the Public Hearing), please
register for the hearing by January 15, 2019, at https://www.eventbrite.com/e/fda-pediatric-tobacco-cessation-part-15-public-hearing-tickets-50167147288. Those without internet or email access can
register and/or request to participate as an open public hearing
speaker or a formal presenter by contacting Theresa Wells by the above
dates (see FOR FURTHER INFORMATION CONTACT).
    FDA will try to accommodate all persons who wish to make a
presentation. Formal oral presenters may use an accompanying slide
deck, while those participating in the open public hearing will have
less allotted time than formal oral presenters and will deliver oral
testimony only (no accompanying slide deck). Individuals wishing to
present should identify the number of the specific question, or
questions, they wish to address. This will help FDA organize the
presentations. Individuals and organizations with common interests
should consolidate or coordinate their presentations and request time
for a joint presentation. Individual organizations are limited to a
single presentation slot. FDA will notify registered presenters of
their scheduled presentation times. The time allotted for each
presentation will depend on the number of individuals who wish to
speak. Registered presenters making a formal oral presentation are
encouraged to submit an electronic copy of their presentation
(PowerPoint or PDF) to<EMAIL_ADDRESS>with the subject line
``Eliminating Youth Electronic Cigarette and Other Tobacco Product Use:
The Role for Drug Therapies'' on or before January 11, 2019. Persons
registered to present are encouraged to arrive at the hearing room
early and check in at the onsite registration table to confirm their
designated presentation time. Actual presentation times, however, may
vary based on how the meeting progresses in real time. An agenda for
the hearing and any other background materials will be made available 5
days before the hearing at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm620744.htm.
    If you need special accommodations because of a disability, please
contact Theresa Wells (see FOR FURTHER INFORMATION CONTACT) at least 7
days before the hearing.
    Streaming Webcast of the Public Hearing: For those unable to attend
in person, FDA will provide a live webcast of the hearing. To join the
hearing via the webcast, please go to https://collaboration.fda.gov/ptc120518.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Dockets Management Staff (see ADDRESSES).

IV. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by FDA senior management from the Office of the
Commissioner, the Center for Drug Evaluation and Research, and the
Center for Tobacco Products. Under Sec.  15.30(f) (21 CFR 15.30(f)),
the hearing is informal and the rules of evidence do not apply. No
participant may interrupt the presentation of another participant. Only
the presiding officer and panel members can pose questions; they can
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (21 CFR part 10, subpart C). Under 21 CFR 10.205,
representatives of the media may be permitted, subject to certain
limitations, to videotape, film, or otherwise record FDA's public
administrative proceedings, including presentations by participants.
The hearing will be transcribed as stipulated in Sec.  15.30(b) (see
Transcripts). To the extent that the conditions for the hearing, as
described in this notice, conflict with any provisions set out in part
15, this notice acts as a waiver of those provisions as specified in
Sec.  15.30(h).

V. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

1.* U.S. Department of Health and Human Services (2014). ``The
Health Consequences of Smoking--50 Years of Progress: A Report of
the Surgeon General, 2014.'' Atlanta, GA: U.S. Department of Health
and Human Services, Centers for Disease Control and Prevention,
National Center for Chronic Disease Prevention and Health Promotion,
Office on Smoking and Health. (Available at: https://www.surgeongeneral.gov/library/reports/50-years-of-progress/index.html.)
2.* Wang T.W., A. Gentzke, S. Sharapova, et al. (2018). ``Tobacco
Product Use Among Middle and High School Students--United States,
2011-2017.'' Morbidity and Mortality Weekly Report (MMWR) 67:629-
633. (Available at https://www.cdc.gov/mmwr/volumes/67/wr/mm6722a3.htm.)
3.* U.S. Department of Health and Human Services (2016). ``E-
Cigarette Use Among Youth and Young Adults: A Report of the Surgeon
General.'' Atlanta, GA: U.S. Department of Health and Human
Services, Centers for Disease Control and Prevention, National
Center for Chronic Disease Prevention and Health Promotion, Office
on Smoking and Health. (Available at: https://e-cigarettes.surgeongeneral.gov/documents/2016_sgr_full_report_non-508.pdf.)
4. Fanshawe T.R., W. Halliwell, N. Lindson, et al. (2017). ``Tobacco
Cessation Interventions for Young People.'' Cochrane Database of
Systematic Reviews, Rev.11:CD003289. (Available at https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD003289.pub6/epdf/full.)

BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TP18DE18.008

[GRAPHIC] [TIFF OMITTED] TP18DE18.009

    Dated: December 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27352 Filed 12-17-18; 8:45 am]
 BILLING CODE 4164-01-C


[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)]
[Notices]
[Pages 58488-58489]
[FR Doc No: 2015-24625]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-M-2375, FDA-2015-M-0909, FDA-2015-M-0199, FDA-
2015-M-0200, FDA-2015-M-0201, FDA-2015-M-0228, FDA-2015-M-0266, FDA-
2015-M-0267, FDA-2015-M-0431, FDA-2015-M-0502, FDA-2015-M-0690, FDA-
2015-M-0738, FDA-2015-M-0910]

Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
Agency's Division of Dockets Management.

ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Please cite the appropriate docket number as listed in table
1 when submitting a written request. See the SUPPLEMENTARY INFORMATION
section for electronic access to the summaries of safety and
effectiveness.

FOR FURTHER INFORMATION CONTACT: Melissa Torres, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with sections 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the FD&C Act. The
30-day period for requesting reconsideration of an FDA action under
Sec.  10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a
PMA begins on the day the notice is placed on the Internet. Section
10.33(b) provides that FDA may, for good cause, extend this 30-day
period. Reconsideration of a denial or withdrawal of approval of a PMA
may be sought only by the applicant; in these cases, the 30-day period
will begin when the applicant is notified by FDA in writing of its
decision.
    The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from January 1, 2015, through March 31,
2015. There were no denial actions during this period. The list
provides the manufacturer's name, the product's generic name or the
trade name, and the approval date.

   Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From January 1, 2015,
                                             Through March 31, 2015
----------------------------------------------------------------------------------------------------------------
         PMA No., Docket No.                    Applicant                    Trade name            Approval date
----------------------------------------------------------------------------------------------------------------
P980040/S049, FDA-2014-M-2375.......  Abbott Medical Optics, Inc..  TECNIS[supreg] multifocal 1-      12/17/2014
                                                                     piece intraocular lens.
P140010, FDA-2015-M-0199............  Medtronic, Inc..............  IN.PACTTM AdmiralTM               12/30/2014
                                                                     Paclitaxel-coated
                                                                     Percutaneous Transluminal
                                                                     Angioplasty Balloon
                                                                     Catheter.
P130019, FDA-2015-M-0201............  EnteroMedics, Inc...........  Maestro[supreg] Rechargeable       1/14/2015
                                                                     System.
P130025, FDA-2015-M-0200............  Koning Corp.................  Koning Breast CT (Model CBCT       1/14/2015
                                                                     1000).
P060001/S020, FDA-2015-M-0228.......  ev3, Inc....................  Prot[eacute]g[eacute]TM GPS        1/21/2015
                                                                     Self-Expanding Peripheral
                                                                     Stent System.
H140001, FDA-2015-M-0267............  ABIOMED, Inc................  Impella RP System...........       1/23/2015

P140017, FDA-2015-M-0266............  Medtronic, Inc..............  MelodyTM Transcatheter             1/27/2015
                                                                     Pulmonary Valve (TPV) and
                                                                     EnsembleTM Transcatheter
                                                                     Valve Delivery System.
P130023, FDA-2015-M-0431............  Cohera Medical, Inc.........  TissuGlu[supreg] Surgical           2/3/2015
                                                                     Adhesive.
P010047/S036, FDA-2015-M-0502.......  NeoMend, Inc................  ProGelTM Pleural Air Leak          2/13/2015
                                                                     Sealant.
P140018, FDA-2015-M-0690............  Covidien, LLC...............  VenaSealTM Closure System...       2/20/2015
H130001, FDA-2015-M-0909............  Biologics Consulting Group,   Lixelle Beta 2-microglobulin        3/5/2015
                                       Inc..                         Apheresis Column.
P110024, FDA-2015-M-0738............  Advanced Circulatory          ResQCPRTM System............        3/6/2015
                                       Systems, Inc..
P130013, FDA-2015-M-0910............  Boston Scientific Corp......  WATCHMANTM Left Atrial             3/13/2015
                                                                     Appendage (LAA) Closure
                                                                     Technology.
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.

    Dated: September 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24625 Filed 9-28-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: August 17, 2010 (Volume 75, Number 158)]
[Notices]
[Page 50791]
[DOCID:fr17au10-88]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62602; File No. SR-CBOE-2010-069]

 Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change to Amend Its Minor Rule Violation Plan

July 29, 2010.

Correction

    In notice document 2010-19332 beginning on page 47672 in the issue
of Friday, August 6, 2010, make the following correction:
    On page 47672, in the third column, in the document heading, the
date is corrected to read as set forth above.

[FR Doc. C1-2010-19332 Filed 8-16-10; 8:45 am]
BILLING CODE 1505-01-D


1 March 28, 2002 Esteban Mujica Cotto, Esq. President Puerto Rico Environmental Quality Board P. O. Box 11488 San Juan, Puerto Rico 00910 1488 Dear Mr. Cotto:

The U. S. Environmental Protection Agency ( EPA) has completed its review of the revisions to the Puerto Rico Water Quality Standards Regulation ( PRWQSR) under Resolution Number 90 26 1. These revisions, except for the required certification of the Commonwealth's Secretary of Justice ( Attorney General), were sent to EPA by the Puerto Rico Environmental Quality Board ( PREQB) on September 21, 1990. These revisions were adopted by the Commonwealth and became effective on October 27, 1990. In taking this action, EPA considered the following documents submitted in connection with the revised PRWQSR:

1. the certification from the Commonwealth's Secretary of Justice Ms. Anabelle Rodriguez ( Attorney General) that the standards were duly adopted pursuant to Commonwealth law, such certification dated January 8, 2002 and submitted to EPA on February 25, 2002;

2. the applicable notices from the El Nuevo dia and the San Juan Star ( dated February 24, 1990, February 25, 1990, March 9, 1990, March 10, 1990, and September 15, 1990).

3. Responsiveness Summary to the comments received during public hearings on May 2 and 3, 1990 and July 12 and 13, 1990 ( dated October 2, 1990).

Under Section 303( c) of the Clean Water Act ( CWA), 33 U. S. C. § 1313( c), states are required to conduct a triennial review of their water quality standards and submit any new or revised standards to EPA for review. Federal regulations at 40 C. F. R. § § 131.21 and 131.22 implement these requirements. Puerto Rico's previous review and revision of its water quality standards regulations were completed and adopted November 5, 1987. As part of the 1990 review process, PREQB held four public hearings to receive public input and comment on the proposed revisions to the PRWQSR on May 2 and 3, 1990 and July 12 and 13, 1990. EPA did not receive the Attorney General's certification required under 40 CFR 131.6( e) until February 25, 2002. EPA considers the adoption of revisions to the PRWQSR, along with the public review and comment process, to constitute the Commonwealth's triennial review of water quality 2 standards. Based on our review, PREQB's procedures are consistent with, and satisfy the procedural requirements of 40 C. F. R. § 131.20.

The following constitute the revisions which are being addressed under this action. These revisions enhance the Puerto Rico water quality standards, and represent improvements in the PRWQSR.

° revisions to the Puerto Rico antidegradation policy, which are approved as being consistent with the requirements under 40 C. F. R. § 131.12;

° the adoption of several new and revised definitions ( Article 1), which are approved as being consistent with the requirements under 40 C. F. R. § 131.3;

° the inclusion of wetlands in the definition of " Waters of Puerto Rico" ( Article 1), which is approved as being consistent with the requirements under 40 C. F. R. § 122.2;

° revisions to further clarify the geographic applicability of the water body classifications in Puerto Rico ( Classes SA, SB, SC, SD, SE and SG) ( Article 2.1  2.3), which are approved as being consistent with the requirements under 40 C. F. R. § 131.6( a) and, 40 C. F. R. § 131.10( a);

° the revision of the narrative criteria for " solids and other matter," and " color, odor, taste and turbidity" ( Articles 3.1.1 and 3.1.2) to specify the protection of existing and designated uses, which are approved as being consistent with the requirements under 40 C. F. R. § 131.6( c) and, 40 C. F. R. § 131.11( a);

° the revision of the ambient temperature criterion ( Article 3.1.4 ( A)) to lower the highest allowable temperature from 94o F to 90oF, which is approved as being consistent with the requirements under 40 C. F. R. § 131.6( c) and, 40 C. F. R. § 131.11( a);

° the adoption of narrative criteria for " biochemical oxygen demand" and " oil and grease" ( Articles 3.1.6 and 3.1.8), which are approved as being consistent with the requirements under 40 C. F. R. § 131.6( c) and, 40 C. F. R. § 131.11( a);

° the revision of the narrative criteria for " substances in toxic concentrations and synergistic toxic effects" ( Article 3.1.9) to include synergistic effects, which is approved as being consistent with the requirements under 40 C. F. R. § 131.6( c) and, 40 C. F. R. § 131.11( a);

° the adoption of new or revised chemical specific numeric criteria for the following toxic pollutants in " surface waters:" cadmium, copper, lead, nickel, aldrin, dieldrin, chlordane, DDT and metabolites, endosulfan, endrin, lindane, toxaphene, chloropyrifos, 2,4 D, parathion and dichlorobenzenes ( Articles 3.1.9( A),( B) and ( C)), which are approved as being consistent with the requirements under 40 C. F. R. § 131.11; 3 ° the adoption of new or revised chemical specific numeric criteria for the following toxic pollutants in " coastal/ estuarine waters:" aldrin, dieldrin, chlordane, DDT and metabolites, endosulfan, endrin, lindane, toxaphene, chloropyrifos and dichlorobenzenes ( Articles 3.1.9( A),( B) and ( C)), which are approved as being consistent with the requirements under 40 C. F. R. § 131.11; and,

° the revision of the color criterion for Class SD waters from 10 to 15 units according to the colorimetric platinum cobalt standard ( Article 3.2.4. B. 4), which is approved as being consistent with the requirements under 40 C. F. R. § 131.6( c) and, 40 C. F. R. § 131.11( a).

By this letter, I am pleased to approve the above revisions to the PRWQSR, pursuant to Section 303( c) of the CWA. I am also approving the temporary exemption provisions in Article 9 of PRWQSR. This latter approval is based in part on the March 15, 2002 letter from Ms. Ivonne Santiago, Director of the Water Quality Area, to Ms. Kathleen C. Callahan, Director of the Division of Environmental Planning and Protection. In this letter PREQB stated that any approval by the Commonwealth of a temporary exemption ( variance) will comply with the following terms and conditions: ( 1) the application will contain a justification for the requested variance consistent with 40 C. F. R. § 131.10( g)( 6), that the costs necessary to comply with the relevant water quality standard( s) would result in substantial economic and social impacts; ( 2) the variance shall be adopted only after completion of a public participation process, in conformity with Puerto Rican law and/ or regulation, as would apply to any revision to the PRWQSR; ( 3) the variance shall be submitted for EPA review and approval as a change to water quality standards before it may take effect ( 40 CFR 131.21); and ( 4) if approved, the variance shall be published in the PRWQSR. Publication of a temporary, case by case variance in the PRWQSR may occur during the following update or printing of the PRWQSR. Also, I note that such variances will be implemented only in the context of a NPDES permit action, and that EPA is at present the permitting authority for NPDES permit issuance in Puerto Rico. In issuing NPDES permits in Puerto Rico, EPA intends to exercise such authority only upon compliance with all of the above four elements. Finally, it is my understanding that PREQB has included all of EPA's requested changes to Article 9 in its February 2002 proposed revisions to the PRWQSR. Once PREQB has officially adopted these revisions and submits them to EPA, we will review and take action on them.

EPA is not taking action on the criteria for the following substances: Asbestos ( Article 3.1.7); beryllium ( Class SD waters), manganese ( Class SD waters), and nickel ( Class SB and SC waters) ( Article 3.1.9( A)); pentachlorophenol ( Article 3.1.9( B); benzene, vinyl chloride, 1,2 dichloroethane, 1,1 dichloroethylene, tetrachloroethylene, carbon tetrachloride, 1,1,1 trichloroethane and tricholoroethylene ( Article 3.1.9( C); and, total ammonia ( Article 3.2.4( B)( 13), since these criteria were stayed by PREQB on August 17, 1990. Because these criteria were stayed, they do not constitute " revised or new" standards subject to review under section 303( c)( 2)( A) of the Clean Water Act.

In addition, EPA is not taking action pursuant to Section 303( c) of the CWA on Article 10 of the PRWQSR, since this section addresses the development and implementation of wasteload allocations ( WLAs), which is an implementation provision related to total maximum 4 daily loads ( TMDL) under Section 303( d) of the CWA, rather than an element of Section 303( c) of the CWA relating to water quality standards. EPA's TMDL staff will work with PREQB staff to identify and address any remaining concerns related to PREQB's TMDL/ WLA development and implementation procedures in Article 10 of the PRWQSR.

EPA Region II looks forward to continuing to work with PREQB to further improve the PRWQSR. In a January 14, 2002 letter from Ms. Callahan to Ms. Santiago, EPA provided PREQB with the results of EPA's review of the 2002 draft revisions to the PRWQSR. Under separate cover, EPA will identify any further additions, deletions or modifications which may be required to bring the PRWQSR into full compliance with the CWA and its implementing regulations.

If you have any questions, please call me at ( 212) 637 5000 or have your staff contact Ms. Kathleen C. Callahan, Director, Division of Environmental Planning and Protection at ( 212) 637 3725.

Sincerely,

Jane M. Kenny Regional Administrator cc: Ivonne Santiago, PREQB Ruben Gonzalez, PREQB bcc: Jose Font, PREQB Ariel Iglesias, PREQB Carl Axel Soderberg, CEPD William Morrow, OST Marjorie Pitts, OST M. E. Levine, OGC Kathleen Callahan, DEPP Kevin Bricke, DEPP Walter Mugdan, ORC Warren Llewellyn, ORC Richard Weisberg, ORC Mario Del Vicario, CEPB Felix Locicero, CEPB Wayne Jackson, CEPB G:\...\ SWQB\ TES\ WQS\ PR\ prwqs90. approve. wpd


[Federal Register Volume 81, Number 20 (Monday, February 1, 2016)]
[Rules and Regulations]
[Page 5041]
[FR Doc No: 2016-01730]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2016-0039]

Drawbridge Operation Regulations; Inner Harbor Navigation Canal
and Chef Menteur Pass, Both at New Orleans, LA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulations.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Senator Ted Hickey (Leon C. Simon
Blvd./Seabrook) bascule bridge across the Inner Harbor Navigation
Canal, mile 4.6, at New Orleans, Louisiana, and the US 90 bridge at
Chef Menteur Pass over Lake Catherine at Mile 2.8 at New Orleans,
Orleans Parish, Louisiana. The deviation is necessary to accommodate
the Ochsner Ironman 70.3 New Orleans event. This deviation allows the
bridges to remain closed-to-navigation for a scheduled amount of time
on the day of the event.

DATES: This deviation is effective from 7 a.m. through 5 p.m. on April
17, 2016.

ADDRESSES: The docket for this deviation, [USCG-2016-0039] is available
at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Jim Wetherington, Bridge
Administration Branch, Coast Guard, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Premier Event Management, through the
Louisiana Department of Transportation and Development (LDOTD),
requested a temporary deviation from the operating schedule of the
Senator Ted Hickey (Leon C. Simon Blvd./Seabrook) bascule bridge across
the Inner Harbor Navigation Canal, mile 4.6, at New Orleans, Louisiana,
and the US 90 Bridge at Chef Menteur Pass over Lake Catherine at Mile
2.8 at New Orleans, Orleans Parish, Louisiana. The deviation was
requested to accommodate the Ochsner Ironman 70.3 New Orleans event.
The vertical clearance of the Senator Ted Hickey (Leon C. Simon Blvd./
Seabrook) bascule bridge is 46 feet above mean high water in the
closed-to-navigation position and unlimited in the open-to-navigation
position. The bridge is governed by 33 CFR 117.458(c). The vertical
clearance of the US 90 swing-span bridge at Chef Menteur Pass over Lake
Catherine is 11 feet above mean high water in the closed-to-navigation
position and unlimited in the open-to-navigation position. The bridge
is governed by 33 CFR 117.436.
    This deviation is effective on April 17, 2016. The bridge over the
Inner Harbor Navigation Canal will be closed to marine traffic from 8
a.m. through 5 p.m. and the bridge over Chef Menteur Pass will be
closed from 7 a.m. through 1 p.m. This deviation allows the bridges to
remain closed-to-navigation for the duration of the event as it impacts
each bridge according to the schedule.
    Navigation on the waterway consists of small tugs with and without
tows, commercial vessels, and recreational craft, including sailboats.
    Vessels able to pass through these bridges in the closed-to-
navigation position may do so at anytime. The bridges will be able to
open for emergencies, and there is no immediate alternate route. The
Coast Guard will also inform the users of the waterways through our
Local and Broadcast Notices to Mariners of the change in operating
schedule for each bridge to minimize any impact caused by the temporary
deviation.
    In accordance with 33 CFR 117.35(e), each drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: January 26, 2016.
David M. Frank,
Bridge Administrator, Eighth Coast Guard District.
[FR Doc. 2016-01730 Filed 1-29-16; 8:45 am]
 BILLING CODE 9110-04-P