[Federal Register: September 12, 2007 (Volume 72, Number 176)]
[Notices]
[Page 52188-52191]
[DOCID:fr12se07-131]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56370; File No. SR-NYSE-2007-81]

Self-Regulatory Organizations; New York Stock Exchange, LLC;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to Rule 104 (Dealings by Specialists)

September 6, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 5, 2007, the New York Stock Exchange, LLC (``NYSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been substantially prepared by the Exchange.
The Exchange filed the proposed rule change as a ``non-controversial''
proposed rule change pursuant to Section 19(b)(3)(A) \3\ of the Act and
Rule 19b-4(f)(6) thereunder,\4\ which renders the proposal effective
upon filing with the Commission. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Exchange Rule 104(e) to modify the
conditions that govern the ability of the specialists to provide price
improvement pursuant to NYSE Rule 104(b)(i)(H).\5\ The text of the
proposed rule change is available at the Exchange, the Commission's
Public Reference Room, and http://www.nyse.com.

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    \5\ The Exchange notes that on March 22, 2006, the Commission
approved a proposed rule change to permit the Exchange to establish
the NYSE HYBRID MARKETSM (``Hybrid Market''). See
Securities Exchange Act Release No. 53539 (March 22, 2006), 71 FR
16353 (March 31, 2006) (SR-NYSE-2004-05). Included in the proposed
rule change were Exchange rules governing specialist algorithmic
systems, including Rules 104(b)(i)(H) and 104(e).
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these

statements may be examined at the places specified in Item IV below.
NYSE has substantially prepared summaries, set forth in Sections A, B,
and C below, of the most significant aspects of such statements.

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

1. Purpose
    In the proposed rule change, the Exchange seeks to amend Exchange
Rule 104(e) to modify the conditions that govern the ability of the
specialists to provide price improvement pursuant to NYSE Rule
104(b)(i)(H). The Exchange seeks to amend Rule 104(e) to allow the
specialist to provide price improvement to an order when the specialist
is represented in a meaningful amount in the bid with respect to price
improvement provided to an incoming sell order and in the offer with
respect to price improvement provided to an incoming buy order without
minimum trade price parameters based on the quotation spread.
    Current Price Improvement Conditions. Pursuant to Exchange Rule
104(b)(i)(H), a specialist trading message to provide price improvement
to an order is subject to the conditions set forth in paragraph (e) of
Exchange Rule 104. Currently, Exchange Rule 104(e) sets forth the
requirements for specialist algorithmic price improvement, which
include minimum trade price parameters based on the quotation spread,
as long as the specialist is represented in the Exchange quotation in a
meaningful amount as defined in the rule.\6\
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    \6\ Exchange Rule 104(e)(ii) defines meaningful amount as at
least 1,000 shares for the 100 most active securities on the
Exchange (as the Exchange from time to time shall determine), based
on average daily volume, and at least 500 shares for all other
securities on the Exchange.
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    Pursuant to Rule 104(e), specialists may price improve all or part
of an incoming order, as follows:
    (i) The specialist is represented in the bid if buying and the
offer if selling; and
    (ii) Where the quotation spread is three-five cents, algorithms
must provide price improvement of at least two cents; or
    (iii) Where the quotation spread is more than five cents,
algorithms must provide price improvement of at least three cents; or
    (iv) where the quotation spread is two cents, algorithms must
provide price improvement of one cent.
    Examples:
    (1) If the Exchange quotation is 20.10-20.15, and the specialist is
represented in both the bid and offer, the algorithm can provide price
improvement by buying at 20.12, and selling at 20.13.
    (2) If the Exchange quotation is 20.10-20.16, and the specialist is
represented in both the bid and the offer, the algorithm can buy at
20.13 and sell at 20.13.
    (3) If the Exchange quotation is 20.10-20.12, and the specialist is
represented in both the bid and the offer, the algorithm can buy at
20.11 and sell at 20.11.
    Proposal to Amend Price Improvement Parameters. The Hybrid Market
rules, including those identified above, were implemented in a series
of phases beginning with a pilot on December 14, 2005 through February
27, 2007. During the implementation process, the Exchange continually
reviewed the operation of the Hybrid Market and changes in the behavior
of market participants resulting from the new rules in order to assess
whether the rules resulted in operations as envisioned by the Hybrid
Market initiative. As a result of this continual review, NYSE amended
certain rules to better accomplish the goals intended with the creation
of the Hybrid Market.\7\
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    \7\ See, Securities Exchange Act Release Nos. 54820 (November
27, 2006), 71 FR 70824 (December 6, 2006) (SR-NYSE-2006-65)
(amendment to clarify certain definitions and systematic processing
of certain orders in the Hybrid Market); 55316 (February 20, 2007),
72 FR 8825 (February 27, 2007) (SR-NYSE-2007-14) (amendment of
Exchange Rule 70.30 in order to remove the concept of a Crowd being
``specific areas on the Floor where Floor brokers are generally able
to see and hear the business'' conducted at each post/panel to
``specific identifiable areas where Floor brokers are able to
conduct business at each post/panel within the Crowd''); 54427
(September 12, 2006), 71 FR 54862 (September 19, 2006) (SR-NYSE-
2006-58) (amendment of Exchange Rule 70.30 to remove the concept of
a Crowd as ``any five contiguous panels'' to ``specific identifiable
areas on the Floor where Floor brokers are generally able to see and
hear the business conducted at each post/panel within the Crowd'');
and 54086 (June 30, 2006), 71 FR 38953 (July 10, 2006) (SR-NYSE-
2006-24) (amendment to Exchange Rule 104(d)(i) to conform the
minimum display requirements for reserve interest for specialists
and Floor brokers such that specialists, like Floor brokers, only be
required to provide at least 1,000 shares displayed interest at the
bid and offer in order to have reserve interest on that side of the
quote).
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    The Exchange states that it proposed the price improvement
parameters in an attempt to balance the goals of preserving incentives
for the limit orders on the Display Book to establish the best price
and of encouraging price improvement for incoming orders. The Exchange
believed that the benefit of providing meaningful price improvement to
incoming orders under such circumstances would outweigh the potential
disincentives to post aggressive limit orders.
    At the time these parameters were included in Exchange Rule 104,
the Exchange believed that the stated parameters would discourage the
specialist from posting a quote that would improve the best bid or
offer by one cent, thus effectively stepping ahead of other liquidity
providers to get price priority for execution (i.e., ``Penny-ing'').
    According to NYSE, a review of its Hybrid Market has demonstrated
that specialists' provision of price improvement has diminished. At the
same time, other market participants who may have historically competed
with the specialist to provide price improvement are doing so less
frequently than before.\8\ As a result, the Exchange's level of price
improvement is at a historic low.
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    \8\ The Exchange reviewed statistics related to price
improvement by specialists and other market participants for July
2006 and July 2007. It showed that the rate of specialist price
improvement in July 2006 was 1.47% as compared to 0.03% in July
2007. In addition, the price improvement offered by other market
participants was 10.66% in July 2006 and 1.39% in July 2007.
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    It is the view of the Exchange that if the frequency of price
improvement for customers is meaningfully increased and the deployment
of additional provisional liquidity is sufficiently encouraged,
enhanced market quality will result. It is also the Exchange's view
that encouraging specialist firms and their on- and off-Floor
counterparts to compete at and inside the national best bid or offer
should result in lower intra-day volatility, further enhancing market
quality and depth.
    Moreover, according to NYSE, the Exchange's review of its Hybrid
Market also has demonstrated that, since the inception of the Hybrid
Market, the NYSE quote spread has narrowed.\9\ As a result, it is the
Exchange's view that the price improvement parameters by which the
specialists must abide are no longer warranted, and are in fact
unnecessarily burdensome and counter-productive.
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    \9\ See NYSE Completes Hybrid Market Phase III Activation
(January 24, 2007) at http://www.nyse.com/press/1169637018870.html; see

also, Hybrid Market Performance and Execution Quality Very Positive,
NYSE Says (November 2, 2006) at http://www.nyse.com/press/1162466220165.html
.

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    The Exchange further believes that the concerns over Penny-ing are
outdated. Specifically, the average quoted spread of 96% of the daily
volume in NYSE-listed securities is five cents or less. Price
improvement in the amount of a penny in these securities is the
equivalent of 20% price improvement where the spread is five cents to
as much as 100% price improvement where the spread is one cent. Today,

several other market centers already provide price improvement in sub-
penny increments to their customers.\10\ Given the current low overall
price improvement being generated in NYSE-listed securities, the
Exchange firmly believes that amending Rule 104(e) will lead directly
to enhanced market quality.
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    \10\ The Exchange states that, included in the market centers
that currently provide price improvement in sub-penny increments are
the Boston Stock Exchange, National Stock Exchange, Chicago Stock
Exchange, NASDAQ, and NYSE Arca.
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    Accordingly, the Exchange proposes to amend Exchange Rule 104 to
modify the conditions that govern the operation of the specialist's
algorithmic trading message to allow the specialist to provide price
improvement, without minimum trade price parameters based on the
quotation spread, to an order as set forth in paragraph (e) when the
specialist is represented in a meaningful amount in the bid with
respect to price improvement provided to an incoming sell order and in
the offer with respect to price improvement provided to an incoming buy
order. As such the Exchange seeks to delete subsections (e)(i)(A)-
(e)(i)(D) of the current rule. Pursuant to the proposed rule, the price
improvement to be supplied by the specialist must be at least one cent.
    The Exchange expects that this proposed rule change will prove
beneficial for customers sending orders to the Exchange through added
liquidity, increased price improvement in frequency, and even further
decreased effective spreads.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\11\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\12\ in particular, in that it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, and to remove impediments to and perfect
the mechanism of a free and open market and a national market system.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    Because the Exchange has designated the proposed rule change as one
that does not: (i) Significantly affect the protection of investors or
the public interest; (ii) impose any significant burden on competition;
or (iii) become operative for 30 days after the date of filing (or such
shorter time as the Commission may designate if consistent with the
protection of investors and the public interest), the proposed rule
change has become effective pursuant to Section 19(b)(3)(A) of the Act
\13\ and subparagraph (f)(6) of Rule 19b-4 thereunder.\14\
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    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative prior to 30 days after the date of filing.\15\
However, Rule 19b-4(f)(6)(iii) permits the Commission to designate a
shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has requested that the
Commission waive the 30-day operative delay and designate the proposed
rule change operative upon filing. The Commission believes that waiving
the 30-day operative delay is consistent with the protection of
investors and the public interest because it would allow the Exchange
to encourage price improvement while still requiring specialists to be
represented in a meaningful amount in the bid or offer. The Commission
also notes that the proposed elimination of the minimum price
improvement parameters based on the quotation spread is consistent with
the rules of other exchanges.\16\ Therefore, the Commission designates
the proposal operative upon filing.\17\
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    \15\ 17 CFR 240.19b-4(f)(6)(iii). The Exchange has satisfied the
five-day pre-filing requirement of Rule 19b-4(f)6)(iii).
    \16\ See, e.g., Amex Rule 131-AEMI(q) and NYSE Arca Rule
7.31(h)(4).
    \17\ For purposes only of waiving the operative delay of this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in the furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NYSE-2007-81 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2007-81. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2007-81 and should be
submitted on or before October 3, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-17947 Filed 9-11-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: February 7, 2007 (Volume 72, Number 25)]
[Notices]
[Page 5685-5686]
[DOCID:fr07fe07-53]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-88-001]

El Paso Natural Gas Company; Notice of Compliance Filing

February 1, 2007.
    Take notice that, on January 29, 2007, El Paso Natural Gas Company
(EPNG) submitted a compliance filing pursuant to the Commission's order
issued December 29, 2006 in Docket No. RP07-88-000.
    EPNG states that copies of the filing were served on parties on the
official service list in the above-captioned proceeding.

    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

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

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

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E7-2025 Filed 2-6-07; 8:45 am]

BILLING CODE 6717-01-P


55849 Federal Register / Vol. 68, No. 188 / Monday, September 29, 2003 / Rules and Regulations to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408( n)( 4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

IX. Congressional Review Act The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2).

List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: September 23, 2003. Debra Edwards, Director, Registration Division, Office of Pesticide Programs.

 Therefore, 40 CFR chapter I is amended as follows:

PART 180   [ AMENDED]

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

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

 2. Section 180.473 is revised to read as follows:

§ 180.473 Glufosinate ammonium; tolerances for residues.

( a) General. ( 1) Tolerances are established for residues of the herbicide glufosinate ammonium ( butanoic acid, 2 amino 4( hydroxymethylphosphinyl), monoammonium salt) and its metabolites, 2 acetamido 4 methylphosphinico butanoic acid and 3 methylphosphinico propionic acid, expressed as 2 amino 4 ( hydroxymethylphosphinyl) butanoic acid equivalents, in or on the following food commodities:

Commodity Parts per million Almond, hulls .................. 0.50 Apple ............................... 0.05 Banana ........................... 0.30 Banana, pulp .................. 0.20 Bushberry subgroup 13B 0.15 Cattle, fat ........................ 0.40 Cattle, meat .................... 0.15 Cattle, meat byproducts 6.0 Cotton, gin byproducts ... 15 Cotton, undelinted seed 4.0 Egg ................................. 0.15 Goat, fat .......................... 0.40 Goat, meat ...................... 0.15 Goat, meat byproducts ... 6.0 Grape .............................. 0.05 Hog, fat ........................... 0.40 Hog, meat ....................... 0.15 Hog, meat byproducts .... 6.0 Horse, fat ........................ 0.40 Horse, meat .................... 0.15 Horse, meat byproducts 6.0 Juneberry ........................ 0.10 Lingonberry ..................... 0.10 Milk ................................. 0.15 Nut, tree, group 14 ......... 0.10 Potato ............................. 0.80 Potato, chips ................... 1.60 Commodity Parts per million Potato granules and flakes ........................... 2.00 Poultry, fat ...................... 0.15 Poultry, meat .................. 0.15 Poultry, meat byproducts 0.60 Salal ................................ 0.10 Sheep, fat ....................... 0.40 Sheep, meat ................... 0.15 Sheep, meat byproducts 6.0 ( 2) Tolerances are established for residues of the herbicide glufosinate ammonium ( butanoic acid, 2 amino 4 ( hydroxymethylphosphinyl), monoammonium salt) and its metabolites, 2 acetamido 4 methylphosphinico butanoic acid and 3 methylphosphinico propionic acid, expressed as 2 amino 4 ( hydroxymethylphosphinyl) butanoic acid equivalents, in or on the following food commodities derived from transgenic canola, transgenic cotton, transgenic field corn, transgenic rice, transgenic soybean and transgenic sugar beet that are tolerant to glufosinate ammonium:

Commodity Parts per million Aspirated grain fractions ........... 25.0 Beet, sugar, molasses .............. 5.0 Beet, sugar, roots ..................... 0.9 Beet, sugar, tops ( leaves) ........ 1.5 Canola, meal ............................ 1.1 Canola, seed ............................ 0.4 Corn, field, forage ..................... 4.0 Corn, field, grain ....................... 0.2 Corn, field, stover ..................... 6.0 Cotton, gin byproducts ............. 15 Cotton, undelinted seed ........... 4.0 Rice, grain ................................ 1.0 Rice, hull ................................... 2.0 Rice, straw ................................ 2.0 Soybean .................................... 2.0 Soybean, hulls .......................... 5.0 ( b) Section 18 emergency exemptions. [ Reserved] ( c) Tolerances with regional restrictions. [ Reserved] ( d) Indirect or inadvertent residues. [ Reserved]

[ FR Doc. 03   24565 Filed 9   26   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0218; FRL   7318   2]

Quinoxyfen; Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

VerDate jul< 14> 2003 17: 07 Sep 26, 2003 Jkt 200001 PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29SER1. SGM 29SER1 55850 Federal Register / Vol. 68, No. 188 / Monday, September 29, 2003 / Rules and Regulations SUMMARY: This regulation establishes tolerances for residues of quinoxyfen in or on sweet and tart cherry, grape, and hop, dried cones. Interregional Research Project Number ( IR 4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA). DATES: This regulation is effective September 29, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0218, must be received on or before November 28, 2003. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Hoyt Jamerson, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   9368; e mail address: Jamerson. Hoyt@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:   Crop production ( NAICS 111)   Animal production ( NAICS 112)   Food manufacturing ( NAICS 311)   Pesticide manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0218. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings In the Federal Register of May 30, 2003 ( 68 FR 32497) ( FRL   7295   7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U. S. C. 346a, as amended by FQPA ( Public Law 104   170), announcing the filing of pesticide petitions ( PP 1E6302 and 2E6474) by the Interregional Research Project Number ( IR 4), 681 U. S. Highway # 1 South, North Brunswick, NJ 08902. That notice included a summary of the petitions prepared by Dow AgroSciences LCC, the registrant. The comment period ended June 30, 2003. The petitions requested that 40 CFR 180 be amended by establishing tolerances for residues of the fungicide quinoxyfen, 5,7 dichloro 4( 4 fluorophenoxy) quinoline, in or on grape at 0.70 parts per million ( ppm) ( 1E6302); hop, dried cones at 5 ppm ( 1E6302); and cherry at 0.4 ppm ( 2E6474). Section 408( b)( 2)( A)( i) of the FFDCA allows EPA to establish a tolerance ( the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is `` safe.'' Section 408( b)( 2)( A)( ii) of the FFDCA defines `` safe'' to mean that `` there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408( b)( 2)( C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to `` ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .'' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997) ( FRL   5754   7).

III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408( b)( 2)( D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408( b)( 2) of the FFDCA, for tolerances for residues of quinoxyfen, 5,7 dichloro 4( 4 fluorophenoxy) quinoline in or on cherry, sweet at 0.30 ppm; cherry, tart at 0.30 ppm; grape at 0.60 ppm; and hop, dried cones at 3.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also VerDate jul< 14> 2003 17: 07 Sep 26, 2003 Jkt 200001 PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29SER1. SGM 29SER1 55851 Federal Register / Vol. 68, No. 188 / Monday, September 29, 2003 / Rules and Regulations considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by quinoxyfen are discussed below and summarized in Table 1 of this unit as well as the noobserved adverse effect level ( NOAEL) and the lowest observed adverse effectlevel ( LOAEL) from the toxicity studies reviewed. The primary target organs affected by quinoxyfen are the liver and kidney. Liver effects were seen in rat and mouse subchronic and dog chronic studies. Subchronic effects in rats and mice included increased liver weights, hepatocellular hypertrophy and individual cell hepatocellular necrosis. These effects were noted at high doses and not observed in the chronic rat and mouse studies since they were performed at lower doses. Chronic effects in the dog included increased liver weights, increased alkaline phosphatase levels and increased incidences of slight microscopic hepatic lesions ( increased bile in canaliculi and increased hepatocyte size). Kidney effects were noted only in the rat combined chronic/ carcinogenicity study which resulted in an increased severity of chronic progressive glomerulonephropathy in the males. Rabbits were much more susceptible to the effects of quinoxyfen than any other species. Systemic effects observed in the rabbit developmental study included inanition, loss of body weight, perineal soiling, blood in the cage pan associated with urine, and abortions. Body weight decrements were noted in the rat and/ or mouse subchronic, chronic and carcinogenicity studies and the rabbit developmental and rat reproduction studies. No effects were noted via the dermal route. No evidence of neurotoxicity or neuropathology was seen in any of the submitted studies, including the acute and subchronic neurotoxicity studies. There was no evidence of carcinogenic potential in either the rat chronic toxicity/ carcinogenicity or mouse carcinogenicity studies and no concern for mutagenicity. There was no evidence of increased susceptibility in the oral rat or rabbit developmental studies. There was an increased quantitative susceptibility of young animals following pre/ postnatal exposure to rats in the reproduction study. In this study, no maternal effects were observed up to the highest dose tested ( 100 milligrams/ kilograms/ day ( mg/ kg/ day)); however, minimally reduced F1a pup weights were noted at 100 mg/ kg/ day.

TABLE 1.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Guideline No. Study Type Results 870.3100 90   Day oral toxicity rodents ( rat) NOAEL = 10 mg/ kg/ day LOAEL = 100 mg/ kg/ day based on decreased body weight gain in females, increased liver weights in males and slight hepatocellular hypertrophy ( centrilobular and midzonal; both sexes)

870.3100 90   Day oral toxicity rodents ( mouse) NOAEL = 100 mg/ kg/ day LOAEL = 500 mg/ kg/ day based on increased liver weights, individual cell hepatocellular necrosis and hepatocellular hypertrophy in both sexes 870.3150 90   Day oral toxicity in nonrodents ( dog) NOAEL = 100 mg/ kg/ day LOAEL = Not identified 870.3200 28   Day dermal toxicity ( rat) NOAEL = 1,000 mg/ kg/ day LOAEL = Not identified 870.3700 Prenatal developmental in rodents ( rat) Maternal NOAEL = 1,000 mg/ kg/ day LOAEL = Not identified Developmental NOAEL = 1,000 mg/ kg/ day LOAEL = Not identified 870.3700 Prenatal developmental in nonrodents ( rabbit) Maternal NOAEL = 80 mg/ kg/ day LOAEL = 200 mg/ kg/ day based on inanition, clinical signs, decreased body weights, body weight gains, and food consumption and on increased incidences of abortion Developmental NOAEL = 80 mg/ kg/ day LOAEL = 200 mg/ kg/ day based on increased incidences of abortion 870.3800 Reproduction and fertility effects ( rat) Parental/ Systemic NOAEL = 100 mg/ kg/ day LOAEL = Not identified Reproductive NOAEL = 100 mg/ kg/ day LOAEL = Not identified Offspring NOAEL = 20 mg/ kg/ day LOAEL = 100 mg/ kg/ day based on a minimal decrease in F1a pup weights 870.4100 Chronic toxicity rodents See 870.4300 VerDate jul< 14> 2003 17: 07 Sep 26, 2003 Jkt 200001 PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29SER1. SGM 29SER1 55852 Federal Register / Vol. 68, No. 188 / Monday, September 29, 2003 / Rules and Regulations TABLE 1.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY   Continued Guideline No. Study Type Results 870.4100 Chronic toxicity dogs NOAEL = 20 mg/ kg/ day LOAEL = 200 mg/ kg/ day based on increased alkaline phosphatase, increased absolute and relative ( to body) liver weights, and an increased incidence of very slight to slight microscopic hepatic lesions 870.4200 Carcinogenicity rats See 870.4300 870.4200 Carcinogenicity mouse NOAEL = 80 mg/ kg/ day LOAEL = 250 mg/ kg/ day based on decreased body weight gain in both sexes No evidence of carcinogenicity 870.4300 Combined chronic/ carcinogenicity ( rat) NOAEL = 20 mg/ kg/ day LOAEL = 80 mg/ kg/ day based on increases in severity of chronic progressive glomerulonephropathy in the males and minimal decreases in body weight and body weight gain in the males and females No evidence of carcinogenicity 870.5100 Gene mutation ( bacterial reverse mutation) Negative for inducing reverse mutation in bacteria exposed to doses up to 5,000 µ g/ plate ( S9) and 1,000 µ g/ plate (+ S9)

870.5300 Gene mutation ( In vitro mammalian cell gene mutation) Negative for inducing forward mutation in CHO ( mammalian) cells treated up to 20 µ g/ ml ( S9) and 80 µ g/ ml (+ S9)

870.5375 Cytogenetics ( In vitro mammalian chromosome aberration ( RL)) Negative up to 100 µ g/ ml ( S9 and + S9)

870.5395 Cytogenetics ( mammalian micronucleus ( mouse)) Negative up to 5,000 mg/ kg 870.6200 Acute neurotoxicity screening battery ( rat) NOAEL = 2,000 mg/ kg LOAEL = Not identified 870.6200 Subchronic neurotoxicity screening battery NOAEL = 80 mg/ kg/ day LOAEL = Not identified VerDate jul< 14> 2003 17: 07 Sep 26, 2003 Jkt 200001 PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29SER1. SGM 29SER1 55853 Federal Register / Vol. 68, No. 188 / Monday, September 29, 2003 / Rules and Regulations TABLE 1.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY   Continued Guideline No. Study Type Results 870.7485 Metabolism and pharmacokinetics ( rat) Quinoline labeled and phenyl labeled quinoxyfen were rapidly absorbed with approximately 68 85% of the administered dose being eliminated within 24 hours. Overall recovery of the dosed radioactivity ranged from 83.5 96.2%. Sex, dose, and multiple dosing had little or no effect on the excretion profile at 48 hours post dosing. Changing the position of the 14C label altered the pattern of excretion. The major route of elimination was through the urine in the phenyl labeled test substance ( 44.9 48.7% of dose in urine and 38.2 39.8% of dose in feces) and through the feces in the quinoline labeled test substance ( 65.8 78.3% of dose in feces and 13.4 19.7% of dose in urine). Biliary excretion increased its contribution to fecal radioactivity as the dose increased. Concentrations of radioactivity in the tissues were generally slightly lower in the males than females and in the low dose compared to the high dose group. The highest concentrations of radioactivity were found in the kidney, liver, ovaries, perirenal fat, GI tract and carcass. Maximum plasma concentration occurred between 0.5 and 1.5 hours, and elimination half lives were <= 1 hour and 15 19 hours ( 10 mg/ kg group) and 2 3 hours and 18 22 hours ( 500 mg/ kg group). The presence of several radioactive components was determined in the unhydrolyzed urine ( up to 12), fecal extracts ( up to 8), and bile ( up to 6). No differences in the metabolite profile were observed that were related to sex or multiple dosing Increasing amounts of the parent compound were found in the feces with increasing dose. No other dose related differences were observed. Identified metabolites accounted for 41.0 42.8% dose in the [ Phenyl U 14C] XDE 795 treated group, and only 17.0 31.7% dose in the other treated groups. The [ Phenyl U 14C] XDE 795 treated group had no urinary metabolites in common with the [ 2 Quinoline 14C] XDE 795 treated groups suggesting cleavage of the parent molecule An acid labile conjugate of 4 fluorophenol was found in the urine of the [ Phenyl U 14C] XDE 795 treated group ( 28.7 32.8% dose). 5,7 Dichloro 4 hydroxyquinoline was observed in the urine of the [ 2 Quinoline 14C] XDE 795 treated groups in small quantities ( 0.7 1.7% dose). Thus, the identified metabolites in the urine followed diaryl ether cleavage of the parent compound. Fluorophenyl ring OH XDE 795 ( two isomers) were found in the feces of all treated groups ( 5.4 10.6% dose). In the bile of the treated groups, two major metabolites were identified, a glucuronide and/ or sulfate conjugate( s) of the two isomers of fluorophenyl ring hydroxy XDE 795 ( 9 19% dose) and an unidentified metabolite ( 13 21% dose).

B. Toxicological Endpoints The dose at which no adverse effects are observed ( the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern ( LOC). However, the lowest dose at which adverse effects of concern are identified ( the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor ( UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences. For dietary risk assessment ( other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose ( acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF ( RfD = NOAEL/ UF). Where an additional safety factor ( SF) is retained due to concerns unique VerDate jul< 14> 2003 17: 07 Sep 26, 2003 Jkt 200001 PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29SER1. SGM 29SER1 55854 Federal Register / Vol. 68, No. 188 / Monday, September 29, 2003 / Rules and Regulations to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose ( aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF. For non dietary risk assessments ( other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF ( 10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures ( margin of exposure ( MOE) = NOAEL/ exposure) is calculated and compared to the LOC. The linear default risk methodology ( Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases ( e. g., risk is expressed as 1 x 10 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non linear approach, a `` point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure ( MOEcancer = point of departure/ exposures) is calculated. A summary of the toxicological endpoints for quinoxyfen used for human risk assessment is shown in Table 2 of this unit:

TABLE 2.   SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR QUINOXYFEN FOR USE IN HUMAN RISK ASSESSMENT Exposure Scenario Dose Used in Risk Assessment UF FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute dietary ( females 13 50 years of age) and acute dietary ( general population including infants and children) Not applicable Not applicable There were no toxic effects attributable to a single dose. Therefore, an endpoint of concern was not identified to quantitate acute dietary risk to the general population or to the subpopulation females 13 50 years old Chronic dietary ( all populations NOAEL= 20 mg/ kg/ day UF = 100 Chronic RfD = 0.20 mg/ kg/ day FQPA SF = 1 cPAD = chronic RfD/ FQPA SF = 0.20 mg/ kg/ day Combined chronic toxicity/ carcinogenicity study in rat LOAEL = 80 mg/ kg/ day, based upon increases in severity of chronic progressive glomerulonephropathy in the males and minimal decreases in body weight and body weight gain in both sexes Cancer ( oral, dermal, inhalation Classified as not likely to be carcinogenic to humans Not applicable No evidence of carcinogenicity in rats and mice * The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.

C. Exposure Assessment 1. Dietary exposure from food and feed uses. Quinoxyfen is a new chemical and therefore, these are the first tolerances to be established for the residues of quinoxyfen. Risk assessments were conducted by EPA to assess dietary exposures from quinoxyfen in food as follows: i. Acute exposure. Quantitative acute dietary risk assessments are performed for a food use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. There were no toxic effects attributable to a single dose. Therefore, an endpoint of concern was not identified to quantitate acute dietary risk to the general population or to the subpopulation females 13   50 years old. As a result, no acute risk is expected from exposure to quinoxyfen and hence no quantitative acute dietary risk assessment was performed. ii. Chronic exposure. In conducting this chronic dietary risk assessment, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database ( DEEM FCIDTM ) which incorporates food consumption data as reported by respondents in the USDA 1994   1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals ( CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: An unrefined, Tier 1 chronic dietary exposure assessment using tolerancelevel residues and assuming 100% CT for all proposed commodities, and default DEEM Version 7.76 processing factors for all commodities. iii. Cancer. Quinoxyfen has been classified as not likely to be carcinogenic to humans. Therefore, a quantitative risk assessment was not conducted to assess cancer risk. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for quinoxyfen in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of quinoxyfen. The Agency uses the FQPA Index Reservoir Screening Tool ( FIRST) or the Pesticide Root Zone Model/ Exposure Analysis Modeling System ( PRZM/ EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The Screening Concentrations in Ground Water ( SCI GROW) model is used to predict pesticide concentrations in shallow ground water. For a screening level assessment for surface water EPA will use FIRST ( a Tier 1 model) before using PRZM/ EXAMS ( a Tier 2 model). The FIRST model is a subset of the PRZM/ EXAMS model that VerDate jul< 14> 2003 17: 07 Sep 26, 2003 Jkt 200001 PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29SER1. SGM 29SER1 55855 Federal Register / Vol. 68, No. 188 / Monday, September 29, 2003 / Rules and Regulations uses a specific high end runoff scenario for pesticides. Both FIRST and PRZM/ EXAMS incorporate an index reservoir environment, and both models include a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. None of these models include consideration of the impact processing ( mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern. Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations ( EECs) from these models to quantify drinking water exposure and risk as a % RfD or % PAD. Instead drinking water levels of comparison ( DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to quinoxyfen, they are further discussed in the aggregate risk sections see Unit E. Based on the FIRST and SCI GROW models, the EECs of quinoxyfen for chronic exposures are estimated to be 0.8 parts per billion ( ppb) for surface water and 0.006 ppb for ground water. 3. From non dietary exposure. The term `` residential exposure'' is used in this document to refer to nonoccupational non dietary exposure ( e. g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Quinoxyfen is not registered for use on any sites that would result in residential exposure. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408( b)( 2)( D)( v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider `` available information'' concerning the cumulative effects of a particular pesticide's residues and `` other substances that have a common mechanism of toxicity.'' EPA does not have, at this time, available data to determine whether quinoxyfen has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to quinoxyfen and any other substances and quinoxyfen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that quinoxyfen has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http:// www. epa. gov/ pesticides/ cumulative/.

D. Safety Factor for Infants and Children 1. In general. Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty ( safety) factors in calculating a dose level that poses no appreciable risk to humans. 2. Prenatal and postnatal sensitivity. There is no quantitative or qualitative evidence of increased susceptibility of rat and rabbit fetuses to in utero exposure in developmental studies. There is evidence of increased quantitative susceptibility ( minimal decrease in F1a pup weights) in the rat multi generation reproduction study, but the concern is low since: ( 1) The effects in pups are well characterized with a clear NOAEL; ( 2) the pup effects are minimal at the LOAEL and only noted in the first generation offspring; and ( 3) the doses and endpoints selected for regulatory purposes would address the concerns of the pup effects noted in the rat reproduction study. Therefore, there are no residual uncertainties for prenatal/ postnatal toxicity in this study. 3. Conclusion. There is a complete toxicity data base for quinoxyfen and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. There are no residual uncertainties for prenatal/ postnatal toxicity. No additional safety factor is needed for data base uncertainties. No clinical sign of neurotoxicity or neuropathology was seen in the data base. A developmental neurotoxicity study is not required. Therefore, EPA determined that the 10X SF to protect infants and children should be reduced to 1X.

E. Aggregate Risks and Determination of Safety To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water EECs. DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure ( i. e., the PAD) is available for exposure through drinking water ( e. g., allowable chronic water exposure ( mg/ kg/ day) = cPAD  ( average food + residential exposure)). This allowable exposure through drinking water is used to calculate a DWLOC. A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2 liter ( L)/ 70 kg ( adult male), 2L/ 60 kg ( adult female and youth), and 1L/ 10 kg ( child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short term, intermediate term, chronic, and cancer. When EECs for surface water and ground water are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water ( when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in VerDate jul< 14> 2003 17: 07 Sep 26, 2003 Jkt 200001 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29SER1. SGM 29SER1 55856 Federal Register / Vol. 68, No. 188 / Monday, September 29, 2003 / Rules and Regulations drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process. 1. Acute risk. An endpoint of concern was not identified to quantitate acutedietary risk to the general population or to the subpopulation females 13   50 years old. As a result, no acute risk is expected from exposure to quinoxyfen. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to quinoxyfen from food will utilize less than 1% of the cPAD for the U. S. population, 1% of the cPAD for all infants (< 1 year old) and 1% of the cPAD for children ( 1   2 years old), the children subpopulation at greatest exposure. There are no residential uses for quinoxyfen that result in chronic residential exposure to quinoxyfen. In addition, there is potential for chronic dietary exposure to quinoxyfen in drinking water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 3 of this unit:

TABLE 3.   AGGREGATE RISK ASSESSMENT FOR CHRONIC ( NON CANCER) EXPOSURE TO QUINOXYFEN Population Subgroup cPAD mg/ kg/ day % cPAD ( Food) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Chronic DWLOC ( ppb)

U. S. population 0.20 < 1% 0.8 0.006 7,000 All infants (< 1 year old) 0.20 1% 0.8 0.006 2,000 Children ( 1 2 years old) 0.20 1% 0.8 0.006 2,000 3. Short term risk. Short term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Quinoxyfen is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern. 4. Intermediate term risk. Intermediate term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Quinoxyfen is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern. 5. Aggregate cancer risk for U. S. population. Quinoxyfen has been classified as not likely to be carcinogenic to humans. Therefore, quinoxyfen is not expected to pose a cancer risk. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to quinoxyfen residues.

IV. Other Considerations A. Analytical Enforcement Methodology IR 4 has proposed a gas chromatography ( GC) method with mass selective detection ( MSD) entitled Determination of DE 795 Residues in Grape Wine, Must, and Pomace ERC95.26 ( and its supplement S1) for the enforcement of proposed tolerances for residues of quinoxyfen in/ on grapes, cherries, and hops. Method ERC 95.26 is classified as acceptable and conforms with the criteria of OPPTS Harmonized Guideline 860.1340. The petitioner has submitted a study which investigated the behavior of quinoxyfen through MRMs outlined in FDA's Pesticide Analytical Manual ( PAM), Volume I, Appendix II. The study summary reported that depending on spike levels, certain MRM Protocols ( D, E, and F) yielded partial ( incomplete) to complete recoveries of quinoxyfen in grapes ( nonfatty matrix) and ground beef ( fatty matrix). The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755   5350; telephone number: ( 410) 305   2905; email address: residuemethods@ epa. gov.

B. International Residue Limits There are no Mexican, Canadian or Codex maximum residue limits established for quinoxyfen on sweet and tart cherries, grapes, or hops. Therefore, no compatibility problems exist for these tolerances.

V. Conclusion Therefore, tolerances are established for quinoxyfen, 5,7 dichloro 4( 4 fluorophenoxy) quinoline in or on cherry, sweet at 0.30 ppm; cherry, tart at 0.30 ppm; grape at 0.60 ppm; and hop, dried cone at 3.0 ppm. VI. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of the FFDCA provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d) of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP   2003   0218 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 28, 2003. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the VerDate jul< 14> 2003 17: 07 Sep 26, 2003 Jkt 200001 PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29SER1. SGM 29SER1 55857 Federal Register / Vol. 68, No. 188 / Monday, September 29, 2003 / Rules and Regulations grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 703) 603   0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305   5697, by e mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by docket ID number OPP   2003   0218, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 1. You may also send an electronic copy of your request via e mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32).

VII. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408( d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104   4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104   113, section 12( d) ( 15 U. S. C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408( d) of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408( n)( 4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any `` tribal implications''

VerDate jul< 14> 2003 17: 07 Sep 26, 2003 Jkt 200001 PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29SER1. SGM 29SER1 55858 Federal Register / Vol. 68, No. 188 / Monday, September 29, 2003 / Rules and Regulations as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

VIII. Congressional Review Act The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2).

List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: September 23, 2003. James Jones, Director, Office of Pesticide Programs.

 Therefore, 40 CFR chapter I is amended as follows:

PART 180   [ AMENDED]

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

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

 2. Section 180.588 is added to subpart C to read as follows:

§ 180.588 Quinoxyfen; tolerances for residues.

( a) General. Tolerances are established for residues of the fungicide quinoxyfen, 5,7 dichloro 4( 4 fluorophenoxy) quinoline in or on the following raw agricultural commodities:

Commodity Parts per million Cherry, sweet ............................................................................................................................... 0.30 Cherry, tart ................................................................................................................................... 0.30 Hop, dried cones ......................................................................................................................... 3.0 Grape ........................................................................................................................................... 0.60 ( b) Section 18 emergency exemptions. [ Reserved] ( c) Tolerances with regional registrations. [ Reserved] ( d) Indirect or inadvertent residues. [ Reserved]

[ FR Doc. 03   24561 Filed 9   26   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0315; FRL   7328   6]

Sethoxydim; Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes a tolerance for combined residues of sethoxydim ( 2[ 1( ethoxyimino) butyl] 5 [ 2( ethylthio) propyl] 3 hydroxy 2 cyclohexen 1 one) and its metabolites containing the 2 cyclohexen 1 one moiety ( calculated as the herbicide) in or on corn, sweet, forage; corn, sweet, stover; juneberry; lingonberry; pistachio; salal; and safflower and increases the tolerance on cattle, meat by products; corn, sweet, kernels plus cob with husk removed; goat, meat byproducts; hog, meat byproducts; horse, meat byproducts; milk; and sheep, meat byproducts. BASF Corporation requested the tolerances for corn, sweet, forage; corn, sweet, stover and the increase in tolerance for corn, sweet, kernels plus cob with husk removed; milk; and meat products under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA). Interregional Project # 4 ( IR 4) requested the tolerances on juneberry, lingonberry, pistachio, salal, and safflower under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA). DATES: This regulation is effective September 29, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0315, must be received on or before November 28, 2003. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   5697; e mail address: tompkins. jim@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:   Crop Production ( NAICS 111)   Animal Production ( NAICS 112)   Food Manufacturing ( NAICS 311)   Pesticide Manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by VerDate jul< 14> 2003 17: 07 Sep 26, 2003 Jkt 200001 PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29SER1. SGM 29SER1


MEMORANDUM 		 TO:		Docket EPA-HQ-OAR-2009-0734

FROM:	Jill Mozier, EC/R Inc.

DATE:			February 13, 2014

SUBJECT:	Notes from the Environmental Justice Communities Call, February 12, 2014, with David Cole and Gil Wood as presenters

The attached list of attendees signed up for this Environmental Justice (EJ) Communities Call which took place on February 12, 2014 during a snow storm in Research Triangle Park, NC. Due to the snow storm, EPA's offices in RTP closed early and David Cole presented for Gil Wood, until Gil Wood was able to also call in. David presented slides (attached) giving an overview of the residential wood heater NSPS proposal which was published in the Federal Register on February 3, 2014. Following the slide presentation, David opened the call to questions. The questions and answers are summarized below.

   * Question: John Ackerly of the Alliance for Green Heat commented that he was surprised EPA did not address the EJ analysis in the proposed rule's docket and that he was also surprised that this EJ analysis only looked at cancer. John commented that more of an EJ analysis should be done  -  that the EJ analysis should not only have looked at cancer because there are many other impacts that EJ communities face from woodstoves including health effects resulting from indoor air issues. John further commented that there are many studies noting impacts to poor and non-white communities from wood stove emissions, and concluded that EPA is known for doing perfunctory EJ analyses.

Answer: David Cole noted that EPA's contractor (EC/R) had performed an EJ analysis several years ago (which is in the docket) and that this analysis did not find disproportionate impacts. Gil Wood further explained that this EJ analysis did not find/claim that EJ communities were not experiencing health impacts from wood smoke (such as respiratory effects, etc), but rather that these impacts were not disproportionate compared to the general population. Gil further noted that the proposed NSPS included the strictest standards that EPA could set; thus EPA is proposing with these strict standards to help EJ communities and the general population to the maximum degree possible. Laura Mckelvey of EPA further explained that EJ analyses in general look for disproportionate impacts related to proposed rules and are not regarding what health impacts currently exist from emissions. Gil noted that the analysis was not perfunctory and that the Outreach and Information Division (OID), under which the proposed NSPS is being shepherded, is in fact the division that has been the most instrumental  in advancing EJ analyses in permitting and rulemaking not just in OAQPS but Agency-

      wide. Both Gil and Laura asked John to submit his comments and specific suggestions to the docket regarding how EPA could better address his EJ concerns.

   * Question: A call participant noted that in the South wood heaters are essentially luxury items installed in new homes. He asked if there is a modified Method 5 for testing, and what exactly is the test method being proposed.

Answer: Gil Wood noted that the test method for wood stoves is Method 28, which originated back in the 1980's and uses a dilution tunnel in order to replicate the condensation of the hot gases as happens in the atmosphere, whereas Method 5 does not measure those condensed gases. Thus Method 28 gives higher (more conservative) numbers than Method 5 and is better able to replicate what happens in the atmosphere.       			    * Question: A call participant asked if there has been an analysis as to whether the rule will result in an increased cost to the appliances.

Answer: Gil Wood replied that yes, the increased costs are discussed in the preamble and in the Regulatory Impact Analysis (RIA). For woodstoves, it's been estimated that there may be roughly a $100 increase on a $3,000 stove  -  so EPA estimates that there will be some increase, but not a large increase in price.

   * There were no other questions.