[Federal Register Volume 85, Number 141 (Wednesday, July 22, 2020)]
[Notices]
[Pages 44333-44337]
[FR Doc No: 2020-15792]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89334; File No. SR-NASDAQ-2020-037]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing of Proposed Rule Change To Adopt a New ``Early Market
On Close'' Order Type

July 16, 2020.
    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 July 6, 2020, The Nasdaq Stock Market
LLC (``Nasdaq'' or ``Exchange'') filed with the Securities and Exchange
Commission (``SEC'' or ``Commission'') the proposed rule change as
described in Items I and II below, which Items have been prepared by
the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to adopt the ``Early Market On Close'' as a
new order type. The Exchange also proposes to amend Rule 4754 and make
conforming changes to Rules 4703 and 4756.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Rule 4702 to adopt a new Order Type,
entitled the ``Early Market on Close'' or ``EMOC'' Order Type.
Generally speaking, the Exchange intends for the EMOC to be an
additional offering to its Market On Close (``MOC'') Orders, as well as
a competitive alternative to the newly-approved Cboe BZX Market-On-
Close order type (the ``Cboe Market Close'' or ``CMC'').\3\ That is,
EMOC would enable market participants that wish to buy or sell Nasdaq-
listed securities as part of the Nasdaq closing auction (the ``Nasdaq
Closing Cross''), and to obtain matched executions at the Nasdaq
Closing Cross price, the ability to do so at a time that is earlier
than what is possible with ordinary MOC Orders.\4\
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    \3\ See Securities Exchange Act Release No. 34-88008 (January
21, 2020), 85 FR 4726 (January 27, 2020) (SR-BatsBZX-2017-34) (the
``BZX Approval Order'').
    \4\ Pursuant to Rule 4702(b)(11), a MOC is an Order Type entered
without a price that may be executed only during the Nasdaq Closing
Cross. MOC Orders may be entered between 4 a.m. ET and immediately
prior to 3:55 p.m. ET. MOC Orders may be cancelled and/or modified
between 4 a.m. ET and immediately prior to 3:50 p.m. ET. Between
3:50 p.m. ET and immediately prior to 3:58 p.m. ET, an MOC Order can
be cancelled and/or modified only if the Participant requests that
Nasdaq correct a legitimate error in the Order (e.g., Side, Size,
Symbol, or Price, or duplication of an Order). MOC Orders cannot be
cancelled or modified at or after 3:58 p.m. ET for any reason. An
MOC Order shall execute only at the price determined by the Nasdaq
Closing Cross.
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    Specifically, an EMOC Order would be an unpriced Order to buy or
sell a Nasdaq-listed security that the Exchange would seek to match
with other like orders at 3:35 p.m. Eastern Time (``ET''). If so
matched, the Exchange would execute the Order as part of the Nasdaq
Closing Cross.
    If no such match occurs, the Exchange would automatically convert
any unmatched shares of EMOC Orders into a regular MOC Order for
participation in the Nasdaq Closing Cross, while retaining their
original time priority. Once converted, unmatched shares of EMOC Orders
would thereafter be handled in the same manner as an ordinary MOC
Order. Notably, a participant would be able to cancel or modify a
converted EMOC Order for any reason after 3:35 and before 3:50 p.m. ET,
just as it would for a MOC Order, and the participant could cancel or
modify the converted EMOC Order between 3:50 and prior to 3:58 p.m. ET
to correct a legitimate error in the Order, again, just as it could
with a MOC Order. Converted shares of EMOC Orders would execute in the
Nasdaq Closing Cross in the same manner and with the same priority as
does a MOC Order and it would be subject to the same auxiliary, LULD
Closing Cross, and contingency procedures as are MOC Orders. Like MOC
Orders, converted shares of EMOC Orders that remain unexecuted after
the Closing Cross will be canceled.
    The Exchange proposes to allow its members to enter, cancel, or
modify EMOC Orders beginning at 9:30 a.m. ET \5\ and until immediately
prior to 3:35 p.m. ET (or 25 minutes prior to the early closing time on
a day when Nasdaq closes early). Exchange members would not be able to
enter, cancel, or modify EMOC Orders at or after 3:35 p.m. (or at or
after 25 minutes prior to the early closing time on a day when Nasdaq
closes early).\6\
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    \5\ Nasdaq believes that accepting EMOC orders beginning at 9:30
a.m., is appropriate because it observes that this is approximately
the time that its members typically begin to enter regular Market on
Close Orders.
    \6\ The QIX order entry protocol would not be available for the
entry of an EMOC because it is used primarily for quoting purposes.
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    Pursuant to proposed Rule 4702(b)(16)(B), a Participant would be
able to designate the Time-in-Force for an EMOC Order either by
designating a Time-in-Force of ``On Close'' or by entering a Time-in-
Force of IOC and flagging the Order to participate in the Nasdaq
Closing Cross.
    When entering short sale EMOC Orders, Exchange members would be
required to mark them as ``short'' or ``short exempt'' pursuant to Rule
4702(a). The Exchange's System would reject EMOC Orders marked
``short,'' while it would accept and process EMOC Orders marked ``short
exempt'' in accordance with Rule 4763. This will ensure that the
Exchange is able to comply with its obligations under Rule 201 of
Regulation SHO in the event that a short sale circuit breaker is
triggered and the Nasdaq Closing Cross price is not above the national
best bid.\7\
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    \7\ See BZX Approval Order, supra, 85 FR at 4752.
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    At 3:35 p.m. ET (or 25 minutes prior to the early closing time on a
day when Nasdaq closes early), the System would match for execution all
buy and sell EMOC Orders entered into the System with execution
priority determined based on time-received.
    The Exchange would communicate information about the size of
matched EMOC Orders as part of its Early Order Imbalance Indicator
(``EOII'') and Order Imbalance Indicator (``NOII'').\8\

However, the Exchange would not discretely disclose the number of
matched EMOC shares in the EOII and NOII. Instead, the Exchange would
fold this information into its disclosure of the aggregate number of
shares that have been paired at the then Current Reference Price.\9\ In
other words, the EOII and NOII would provide an aggregate disclosure of
the numbers of paired shares that represent EMOC, regular MOCs, Limit
on Close, and Imbalance Only Orders. The disclosure would not specify
the particular Order Types that the paired shares represent.\10\
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    \8\ The NOII is a message that the Exchange disseminates by
electronic means, beginning at 3:55 p.m. ET (or 5 minutes prior to
the early closing time on a day when Nasdaq closes early), and which
contains information about MOC, LOC, IO, and Close Eligible Interest
and the price at which those orders would execute at the time of
dissemination. See Rule 4754(a)(7). The information that the NOII
disseminates includes: (i) The ``Current Reference Price''
(discussed below); (ii) the number of shares represented by MOC,
LOC, and IO orders that are paired at the Current Reference Price;
(iii) the size of any ``Imbalance'' (i.e., the number of shares of
buy or sell MOC or LOC orders that cannot be matched with other MOC,
LOC, or IO order shares at a particular price at any given time);
(iv) the buy/sell direction of any Imbalance; and (v) indicative
prices at which the Nasdaq Closing Cross would occur if the Nasdaq
Closing Cross were to occur at that time and the percent by which
the indicative prices are outside the then current Nasdaq Market
Center best bid or best offer, whichever is closer. See id.
     The EOII is an earlier message that the Exchange disseminates
by electronic means, beginning at 3:50 p.m. ET (or 10 minutes prior
to the early closing time on a day when Nasdaq closes early), and
which contains all of the same categories of information as does the
NOII, except that it excludes indicative pricing information. See
Rule 4754(a)(10).
     The Exchange proposes to amend the definitions of the terms
NOII and EOII so that the Rules state that they will include
information about EMOC Orders and the price at which those Orders
would execute at the time of dissemination.
     Nasdaq also proposes to amend the definition of ``Imbalance''
to include the number of shares of buy or sell EMOC Orders that
cannot be matched with other EMOC Order shares at a particular price
at any given time. Nasdaq notes that this definitional change will
have no practical effect because shares of EMOC Orders that are not
matched at 3:35 p.m. would be converted into regular MOC Orders.
    \9\ As set forth in Rule 4754(a)(7), the term ``Current
Reference Price'' means: (i) the single price that is at or within
the current Nasdaq Market Center best bid and offer at which the
maximum number of shares of MOC, LOC, and IO orders can be paired;
or (ii) if more than one such price exists, the price that minimizes
any imbalance; or (iii) if more than one such price exists, the
entered price at which shares will remain unexecuted in the cross;
or (iv) if more than one such price exists, the price that minimizes
the distance from the bid-ask midpoint of the inside quotation
prevailing at the time of the order imbalance indicator
dissemination. The Exchange proposes to amend the definition of the
term ``Current Reference Price'' so that it also includes shares
representing EMOC Orders (even though EMOC Orders would not affect
the calculation of the Current Reference Price due to the fact that
they would be matched prior to the calculation of the Price). Nasdaq
proposes similar conforming changes to include EMOCs in the
definitions of the terms ``Far Clearing Price'' and ``Near Clearing
Price.''
    \10\ Nasdaq notes that in proposing to disseminate paired EMOC
share information as part of its EOII and NOII, Nasdaq would afford
market participants time to absorb that information and to act on it
in advance of the Nasdaq Closing Cross. That said, Nasdaq does not
believe that market participants would derive any particular benefit
from knowing which of the aggregate paired shares reflected in the
EOII or NOII are attributable to EMOC Orders; such a disclosure
would not contribute to price discovery or otherwise materially
impact participants' decisions as to whether or not to participate
in the Nasdaq Closing Cross.
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    All matched buy and sell EMOC Orders would remain in the System
until the Nasdaq Closing Cross occurs. The System would execute all
previously matched buy and sell EMOC orders, at the Nasdaq Closing
Cross Price, when the Nasdaq Closing Cross occurs.
    If the Nasdaq Closing Cross price is selected and fewer than all
MOC, LOC, IO and Close Eligible Interest would be executed, then Orders
will be executed at the Nasdaq Closing Cross price, with previously
matched EMOCs executing first in priority, and then the remaining
Orders executing pursuant to the existing priority set forth in Rule
4754(b)(3) (as renumbered, (b)(4)). If, due to insufficient trading
interest, no Nasdaq Closing Cross occurs in a security on a trading
day, then the Exchange would cancel all matched EMOCs in the
security.\11\
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    \11\ If, as of the Closing Cross cut-off time, there are matched
EMOCs and a continuous market for a security, but there is no other
crossing interest, then Nasdaq would conduct a Closing Cross with a
Closing Cross price determined pursuant to 4754(b)(2)(A). This
reflects the same procedure that the Exchange would follow in the
event that the only closing interest in a security consisted of
perfectly paired MOC Orders.
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    The Exchange also proposes to amend Rule 4754 to account for EMOC
Orders in Nasdaq's auxiliary procedures and Limit-Up-Limit Down
(``LULD'') Closing Cross. First, in the event that Nasdaq employs
auxiliary procedures due to extraordinary volumes in the Closing
Cross,\12\ Nasdaq proposes to subject EMOC Orders to the same
procedures that would apply to regular MOC Orders.\13\ Second, Nasdaq
proposes to subject EMOC Orders to the same procedures that would apply
to regular MOC Orders in the event that it conducts an LULD Closing
Cross in a security.\14\
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    \12\ See Rule 4754(b)(5).
    \13\ However, under proposed Rule 4754(b)(6)(A), the auxiliary
procedures would provide that Nasdaq may end the order modification
and cancellation periods for EMOCs as early as 3:25 p.m., whereas
for MOCs, Nasdaq may end those periods as early as 3:40 p.m.
    \14\ See Rule 4754(b)(6). Nasdaq notes that paired EMOC shares
participating in an LULD Closing Cross would be executed against
each other, and then other Order Types would execute in price/time
priority order.
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    When Systems disruptions prevent the occurrence of the Nasdaq
Closing Cross in a security,\15\ such that Nasdaq invokes its
contingency procedures, Nasdaq proposes to handle EMOC Orders in the
same manner that it handles other open interest designated for the
Nasdaq close. That is, Nasdaq proposes to cancel all EMOC orders in the
event that an impairment causes it to invoke its contingency procedures
because any such impairment would prevent Nasdaq from executing the
Closing Cross in the security. Moreover, Nasdaq believes that it would
be in the best interest of participants for the Exchange to cancel
their matched EMOCs so as to allow participants determine how best to
manage their orders given the circumstances that would exist under such
a scenario.
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    \15\ See Rule 4754(b)(7).
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    Finally, Nasdaq notes that it proposes to make conforming changes
to various provisions of the Rules, including Rule 4703(a)(1), (c), and
(l), and Rule 4756 (a)(3).
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\16\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\17\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest, because it is an additional offering to its existing MOC
Order type, and it will provide for a competitive alternative to the
CMC order type. The proposed rule change would further remove
impediments to and perfect the mechanisms of a free and open market and
a national market system by promoting competition among national
securities exchanges in the execution of market-on-close orders for
Nasdaq-listed securities at the Nasdaq Closing Cross price.
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    \16\ 15 U.S.C. 78f(b).
    \17\ 15 U.S.C. 78f(b)(5).
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    Unlike CMCs, which siphon off orders from the primary listing
exchanges and thereby threaten to undermine the integrity of the
primary listing exchanges' closing auction processes, the EMOC Order
Type would have no such effects. Instead, EMOC Orders are designed to
help keep market-on-close orders in Nasdaq-listed securities on Nasdaq,
which is sensible given that Nasdaq is the primary listing market for
these securities and its Closing Cross establishes their official
closing prices. The proposal would help to ensure that Nasdaq is able
to continue to conduct its industry-leading Closing Cross auction
smoothly and efficiently, and without undue complexity, to the benefit
of all participants.
    Meanwhile, participants that choose to utilize EMOC Orders could
take comfort in knowing that Nasdaq, unlike BZX, is already experienced
in executing market on close orders in Nasdaq-listed securities and
that Nasdaq has a track record of doing so competently and reliably.
Moreover, because Nasdaq's Closing Cross process is subject to the
Commission's highest regulatory standards for security, integrity,
reliability, and resiliency, participants can feel at ease knowing that
Nasdaq will treat EMOC Orders with the utmost care, and that the
Commission will hold Nasdaq accountable if it fails to do so. The BZX
Market on Close process, on the other

hand, is untested and subject to lower regulatory standards.\18\
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    \18\ See BZX Approval Order, supra, at 4734 (``[T]he fact that
closing auction systems are subject to the heightened requirements
of Regulation SCI for critical SCI systems could encourage market
participants to send MOC orders to closing auctions on the primary
listing exchanges due to the additional regulatory protections
required of such systems.'').
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    The Exchange also believes that its proposed design of EMOC is
equitable, provides for a free and open market, and is in the interests
of investors and the public and a national market system. For example,
Nasdaq believes that it is equitable and in the interest of investors
to provide for unmatched shares of EMOC Orders to convert to regular
MOC Orders at 3:35 p.m. because doing so reduces the operational risk
for market participants relative to other alternatives such as CMC as
they would not have to take additional action to submit new MOC Orders
should they remain interested in participating in the Nasdaq Closing
Cross despite the lack of a match. Meanwhile, participants that do not
wish to proceed with MOC Orders in this instance would remain free to
cancel or modify their orders for at least 15 minutes after conversion.
    Additionally, Nasdaq believes that it is equitable and in the
interest of investors to cancel EMOC Orders in the event that Nasdaq
does not conduct a Closing Cross because to do otherwise would force
market participants to execute EMOC Orders at prices that may be stale
\19\ and which may not reflect the true market price for such
securities. Moreover, Nasdaq notes that this proposal is the same as
how Nasdaq handles other open cross-only interest when no Closing Cross
occurs.
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    \19\ If a disruption prevents the occurrence of Nasdaq Closing
Cross, then under contingency procedures described in Rule
4754(b)(7), the Exchange will execute orders at the Nasdaq Official
Closing Price, which may be, under certain circumstances, the last
consolidated last-sale eligible trade price for a security during
regular trading hours or, if there were no such trades on the day in
question, the Nasdaq Official Closing Price of the security on the
prior trading day.
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    Nasdaq also believes that it is equitable and facilitates a free
and open market to handle EMOC Orders similarly to other Order Types in
the event of extraordinary volume at the close, insufficient trading
interest to conduct an LULD Closing Cross in a security following an
LULD trading pause, the occurrence of an LULD Closing Cross in a
security, and when the Exchange applies contingency procedures.
    Lastly, Nasdaq believes that its proposal facilitates a free and
open market incorporating into its EOII and NOII publications the
numbers of paired shares of EMOC Orders in advance of the Nasdaq
Closing Cross. By including EMOC paired shares information in the EOII
and NOII publications, Nasdaq will ensure that market participants are
adequately informed about the depth of interest in its Closing Cross at
a point in time when they are able to act on that information by
choosing whether to participate in the Closing Cross. Nasdaq notes that
its proposal is consistent with the interests of investors and the
public to simply add EMOC-related paired shares to its aggregate EOII
and NOII disclosures of paired shares, rather than to separately
identify the number of paired shares that are due to EMOC Orders,
because the Exchange does not believe participants would gain any
valuable insights from a separate disclosure. Nasdaq notes that it does
not separately identify paired shares that are attributable to MOC or
Limit on Close Orders.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange believes the
proposal would increase competition among exchanges by offering a
competitive alternative to BZX's Market-On-Close process. Indeed, the
proposal will offer market participants an option to enter early market
on close orders for Nasdaq-listed stocks, while providing the added
benefit of executing those orders in a process that is recognized for
its reliability and which is more highly-regulated than is the BZX
Market Close process. Moreover, unlike other offerings that siphon
orders from the price discovery process on the primary market, Nasdaq's
proposal will not contribute to the fragmentation of the closing
process for Nasdaq-listed securities. Finally, EMOC would offer
participants reduced operational risk by automatically converting their
unmatched EMOCs to MOCs at 3:35 p.m. and retaining its original time
priority, while still affording them the opportunity to cancel
converted orders prior to the Closing Cross Cutoff Time.

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

    No written comments were either solicited or received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2020-037 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2020-037. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for

inspection and copying at the principal office of the Exchange. All
comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2020-037, and should
be submitted on or before August 12, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
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    \20\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-15792 Filed 7-21-20; 8:45 am]
BILLING CODE 8011-01-P


Supporting Statement for Reporting and Recordkeeping Requirements for
National Volatile Organic Compound Emission Standards for Automobile
Refinish Coatings

1.  Identification of the Information Collection

1(a)  Title of Information Collection.

	Reporting and Recordkeeping Requirements for National Volatile Organic
Compound Emission Standards for Automobile Refinish Coatings.  The
information collection request (ICR) number is 1765.08.  The OMB
control number is 2060-0353.  This is a renewal ICR.

2(b)  Short Characterization/Abstract.

	All manufacturers and importers of coatings and coating components
subject to 40 CFR Part 59 Subpart B--N National Volatile Organic
Compound Emission Standards for Automobile Refinish Coatings must submit
an initial report.  The initial report must include the name and mailing
address of the manufacturer or importer.  The rule requires that
containers of all subject automobile refinish coatings and coating
components display the date of manufacture or a code indicating the date
of manufacture. All manufacturers and importers of subject coatings and
coating components must submit an explanation of all date codes used on
automobile refinish coating and coating component containers.  Date code
explanations can be submitted with the initial report.  Thereafter,
respondents must submit explanations of any new date codes within
30 days of their first use.

	The information collection includes initial and periodic reporting
necessary for the EPA to ensure compliance with the promulgated federal
rule for automobile refinish coatings.  The rule will be enforced
through random sampling of coatings to determine VOC content.
Respondents are manufacturers and importers of automobile refinish
coatings and coating components.

2.  Need for and Use of the Collection

2(a)  Need/Authority for the Collection.

	The EPA is required under Section 183(e) of the Clean Air Act (Act)
to regulate VOC emissions from the use of consumer and commercial
products.  Pursuant to Section 183(e)(3), the EPA published a list of
consumer and commercial products and a schedule for their regulation (60
FR 15264).  Automobile refinish coatings were included in Group 1 of the
list.  The standards for such coatings were promulgated on September 11,
1998 (63 FR 48806) and are codified at 40 CFR part 59, subpart B.

	The reports required under the rule enable the EPA to identify all
coating and coating component manufacturers and importers in the United
States, and to determine which coatings and coating components are
subject to the rule based on dates of manufacture.

2(b)  Practical Utility/Users of the Data.

	Agency enforcement personnel will use the information collected
to identify manufacturers and importers subject to the rule and to
determine which coatings and coating components are subject to the rule
by dates of manufacture.

3.  Nonduplication, Consultations, and Other Collection Criteria

	3(a)  Nonduplication.

	The information collected pursuant to the rule is not collected by any
other Federal agency.  Several States regulate automobile refinish
coatings and require certain recordkeeping and reporting activities.
These State rules generally affect body shops; the federal rule affects
coating and coating component manufacturers and importers.  There is
much more recordkeeping associated with the State rules because of the
large number of body shops in the country.  The federal rule affects
approximately 30 manufacturers and importers, and contains reporting
requirements different from those of the State rules.

	3(b)  Public Notice Required Prior to ICR Submission to OMB.

	Notice of this ICR appeared in the May 28, 2013, Federal Register 78 FR
 31921.  The notice contained a 60-day public comment period, which
ended on July 29, 2013.

3(c)  Consultations.

	Input and information was solicited from the affected industry and
State and local governments during the renewal process, some of whom are
listed in table 3.

3(d) Effects of Less Frequent Collection.

	Less frequent information collection would decrease the margin of
assurance that manufacturers are continuing to meet the standards.  This
ICR includes one-time initial reports.  After the initial report, the
only reports required are those explaining any new date codes.  To
determine whether a coating is subject to the rule, explanations of date
codes are necessary.

	3(e)  General Guidelines.

	This ICR adheres to the guidelines for Federal data requestors, as
provided at 5 CFR 1320.6.

	3(f)  Confidentiality.

	All information submitted to the Agency for which a claim of
confidentiality is made will be safeguarded according to the Agency
policies set forth in Title 40, Chapter 1, Part 2,
Subpart B--Confidentiality of Business Information (see 40 CFR 2;
41 FR 36092, September 1, 1976; amended by 43 FR 39999,
September 8, 1978; 43 FR 42251, September 28, 1978; 44 FR 17674,
March 23, 1979).

3(g)  Sensitive Questions.

	None of the reporting or recordkeeping requirements contain sensitive
questions.

4.  The Respondents and the Information Requested

4(a)  Respondents/NAICS Codes.

	Respondents to this information collection are manufacturers and
importers of automobile refinish coatings and coating components.
Manufacturers of automobile refinish coatings and coating components
fall within standard industrial classification (SIC) 2851, "Paints,
Varnishes, Lacquers, Enamels, and Allied Products" and North American
Industry Classification System (NAICS) code 325510, “Paint and Coating
Manufacturing.”  Importers of automobile refinish coatings and coating
components fall within SIC 5198, "Wholesale Trade:  Paints, Varnishes,
and Supplies," NAICS code 422950, “Paint, Varnish and Supplies
Wholesalers,” and NAICS code 444120, “Paint and Wallpaper Stores.”

4(b)  Information Requested.

		(i)  Data items.

The reporting requirements of the rule are listed below.

		Reports					Regulation Reference

		Initial report						59.426(a)

		Explanation of date codes				59.426(a)

		(ii)  Respondent Activities.

The respondent activities required are listed in the first column of
table 1.

5.  The Information Collected--Agency Activities, Collection
Methodology, and Information Management.

5(a)  Agency Activities.

	A list of activities required of the EPA is provided in table 2.

	5(b)  Collection Methodology and Managements

	The information collected under this rule will not warrant being
maintained on a computerized database since the reports are so few in
number.  Also, since the reported information is simple and
straightforward, no standardized reporting forms will be developed.

	5(c)  Small Entity Flexibility.

	Since the reporting requirements of the rule are minimal, no
alternative reporting requirements are instituted for small entities.

	5(d)  Collection Schedule.

	All subject manufacturers and importers must submit to the EPA an
explanation of all date codes displayed on containers of automobile
refinish coatings and coating components within 30 days of first use,
or within 180 days of becoming subject to the rule, whichever is later.
 All manufacturers and importers of subject coatings and coating
components must submit an initial report within 180 days of becoming
subject to the rule.

6.  Estimating the Burden and Cost of the Collection

	6(a)  Estimating Respondent Burden.

	The average annual burden estimates for reporting requirements are
presented in table 1 for all manufacturers.  These numbers were derived
from estimates based on the EPA's experience with other standards, and
from information obtained from the industry representatives listed in
table 3.  These estimates represent the average annual burden that will
be incurred by the affected industry over a 3-year period.  The hours
shown in column A of table 1 are the burden estimate per manufacturer.

	6(b)  Estimating Respondent Costs.

		(i)  Estimating Labor Costs.

	Table 1 also presents estimated costs for the required reporting
activities.  Labor rates and associated overhead costs are based on
hourly rates of $99 for management personnel, $70 for technical
personnel, and $44 for clerical personnel.  These rates were estimated
using a March 2010 civilian wage table from the Bureau of Labor
Statistics, multiplied by 1.6 to account for benefits and overhead.

		(ii)  Estimating Capital and Operations and Maintenance Costs.

There are no capital or operations and maintenance costs associated with
these reporting activities.

	6(c)  Estimating Agency Burden and Cost.

	Because reporting requirements on the part of respondents are required
under section 112 of the Act, no operational costs will be incurred by
the Federal government.  The only costs that the Federal government will
incur are costs associated with the review of reported information, as
presented in table 2.  Hourly labor rates are estimated at $99 for
management personnel, $71 for technical personnel, and $34 for clerical
personnel.  These rates were determined by multiplying the hourly rates
from the 2010 General Schedule (GS) Locality Pay Tables (tenth step) for
GS-15 (management), GS-13 (technical), and GS-7 (clerical), by a factor
of 1.6 to account for benefits and overhead.

6(d)  Estimating Respondent Universe and Total Burden Costs

	The EPA estimates that there are approximately 30 automobile refinish
coating and coating component manufacturers and importers.  Two
requirements in the rule create a burden on respondents: submitting an
initial report, and submitting an explanation of date codes used on
coating and coating component containers.  The EPA estimates that one
new coating or coating component manufacturer or importer will become
affected by the rule each year.  A new regulated entity must submit an
initial report and provide an explanation of any dates codes that are
used to indicate the manufacture date of its products.  The EPA also
estimates that 10 percent (3) of the existing regulated entities will
change their date coding system each year and will have to submit an
explanation of the new system.

	6(e)  Bottom Line Burden Hours and Costs/Master Tables.

		(i)  Respondent Tally.

The bottom line respondent burden hours and costs, presented in table 1,
are calculated by summing the person-hours column and by summing the
cost column.  The annual burden and cost averaged over 3 years is 14
hours and $940.

		(ii)  The Agency Tally.

The bottom line Agency burden and cost, presented in table 2 is
calculated in the same manner as the respondent burden and cost.  The
estimated annual burden and cost averaged over 3 years is 4 hours and
$226.

		(iii)  Variations in the annual bottom line.

This ICR includes reading the rule, the initial report, and date code
explanations as one-time burden and cost items.  To develop the
estimates of annual average burden, these one-time activities were
averaged over 3 years.  The only other activity is reporting of any new
date code explanations.

6(f)  Reasons for Change in Burden.

	There are no changes to the burden estimates we used this ICR request
in the form in the number of respondents.

6(g)  Burden Statement.

	The annual public reporting and recordkeeping burden for this
collection of information is estimated to average 4 hours per respondent
per year.  Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency.  This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to comply
with any previously applicable instructions and requirements; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.  An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.  The OMB control numbers for EPA's regulations are
listed in 40 CFR Part 9 and 48 CFR Chapter 15.

	To comment on the Agency’s need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID No.
OAR-2003-0120, which is available for public viewing at the Air and
Radiation Docket and Information Center in the EPA Docket Center
(EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW, Washington,
DC.  The EPA Docket Center 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 Reading Room is<PHONE_NUMBER>, and the
telephone number for the Air and Radiation Docket and Information Center
is<PHONE_NUMBER>.  An electronic version of the public docket is
available through EPA Dockets (EDOCKET) at     HYPERLINK
"http://www.epa.gov/edocket."  http://www.epa.gov/edocket.    An
electronic version of the public docket is available at
www.regulations.gov.  This site can be used to submit or view public
comments, access the index listing of the contents of the public docket,
and to access those documents in the public docket that are available
electronically.  Also, you can send comments to the Office of
Information and Regulatory Affairs, Office of Management and Budget, 725
17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA.
Please include the EPA Docket ID No.  EPA-HQ-OAR-2003-0120 and OMB
control number 2060-0353.Table 1.  AVERAGE ANNUAL RESPONDENT BURDEN AND
COST OF REPORTING OVER THREE YEARS

	A	B	C

D	E	F

Burden Item

Person Hours

Per Occurrence

(hrs/man.)

Number of

Occurrences

Per Respondent

Per Year

Person Hours

Per Respondent

Per Year (a)

(C=AxB)

Dollars

Per Hour

(a)

Respondents

Per Year (b)

Total Hours

Per Year

(E=CxD)

Total Cost

Per Year (c)

1. Applications	Not Applicable

2. Surveys and Studies	Not Applicable

3. Reporting Requirements

	     A. Read Instructions	2	1	2	70	1	2	$140

     B. Gather Existing Information	Included in 3.C

     C. Write Report

	          Initial Report	2	1	2	99	1	2   (d)	$198

          Date Code Explanation	4	1	4	70	1	4   (d)	$280

          Update Date Codes	2	1	2	70	3	6   (e)	$420

4. Recordkeeping Requirements	Not Applicable

5. Labeling (f)	Not Applicable

Total

14	$1038

a All tasks are assumed to be performed by a technical person ($70/hr)
unless otherwise noted.

b Total number of manufacturers was estimated to be 30.

c Costs were calculated by multiplying the total number of hours by the
hourly wages.

d This assumes there is one new regulated entity every year.

e Assumed that 10% of manufacturers will update their codes each year.

f Although the rule requires the date (or code) to appear on the label,
such labeling is already performed.

Table 2.  AGENCY BURDEN AND COSTS

	A	B	C	D	E	F

Reports	EPA Hours Per

Occurrence	Occurrences

Per Year	Person Hours

Per Year

(Technicall)

C=AxB	Person Hours

Per Year

(Management)

D=Cx0.05	Person Hours

Per Year

(Clericall)

E=Cx0.1	Total Cost

Per Year (a)

Initial Report	1	1	1	0.05	.1	$79

Date Code Report	0.5	1	0.5	0.03	0.05	$40

Date Code Updates	0.5	3	1.5	0.08	0.15	$113

Total

	3	0.16	0.3	$120

a Labor rates: technical, $71/hr; management, $99/hr; clerical, $34/hr.

Table 3.  Consultations

Industry Representatives						Email

Robert Redding, Automotive Service Association<EMAIL_ADDRESS>
Jim Sell, National Paint and Coatings Association<EMAIL_ADDRESS>
State Representatives

Dave Nordberg, Oregon Department of Environmental Quality
<EMAIL_ADDRESS>
Ed Wong, California Air Resources Board<EMAIL_ADDRESS>
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13924 Federal Register / Vol. 68, No. 55 / Friday, March 21, 2003 / Notices exposures are expected for the general population.

D. Cumulative Effects EPA does not have, at this time, available data to determine whether tralkoxydim has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Tralkoxydim is structurally a cyclohexanedione. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, tralkoxydim does not appear to produce a toxic metabolite produced by other substances. For the purposes of these tolerances action, therefore, EPA has not assumed that tralkoxydim has a common mechanism of toxicity with other substances.

E. Safety Determination 1. U. S. population   i. Acute risk. The acute dietary analysis based on the NOAEL of 30 mg/ kg/ day from the rat developmental study using the DEEM computer program estimates that the distribution of single day exposures utilizes 0.02% of acute RfD. The drinking water level of comparisons ( DWLOCs) for acute exposure to tralkoxydim in drinking water calculated for females 13 + years old was 9,000 ppb. The estimated average concentration in surface water for tralkoxydim is 9 ppb. EPA's acute DWLOC is well above the estimated exposures for tralkoxydim in water for the subgroup of concern. For ground water, the estimated environmental concentrations ( EEC's) using the SCIGROW model were all less than 1 ppb. ii. Chronic risk. A DEEM chronic exposure analysis showed that exposure from tolerance level residues in or on wheat, and barley for children 1 to 6 years old ( the subgroup with the highest exposure) would be 1.4% of the RfD. The exposure for the general U. S. population would be less than 1% of the RfD. The DWLOCs for chronic exposure to tralkoxydim in drinking water calculated for U. S. population was 150 ppb and for children ( 1 to 6 years old) the DWLOC was 50 ppb. The estimated average concentration in surface water for tralkoxydim is 9 ppb. EPA's chronic DWLOC is above the estimated exposures for tralkoxydim in water for the U. S. population and the subgroup of concern. Conservative model estimates SCI GROW of the concentrations of tralkoxydim in ground water indicate that exposure will be minimal. iii. Cancer risk. A DWLOC for cancer was calculated as 1 ppb. The estimated concentration in surface water and ground water for tralkoxydim for chronic exposure are 0.9 ppb, 2.8 ppb, ( the 56   day concentration)/ 3, and 0.1 ppb, respectively. The model exposure estimates are less than the cancer DWLOC. EPA concludes that there is a reasonable certainty that no harm will result from aggregate exposure to tralkoxydim residues. 2. Infants and children. The Agency concluded that an extra safety factor to protect infants and children is not needed based on the following considerations: The toxicology data base is complete for the assessment of special sensitivity of infants and children. The developmental and reproductive toxicity data do not indicate increased susceptibility of rats or rabbits to in utero and/ or postnatal exposure. The NOAEL used in deriving the RfD is based on changes in liver function and morphology in male adult dogs ( not developmental or neurotoxic effects) after chronic exposure and thus are not relevant for enhanced sensitivity to infants and children. Unrefined dietary exposure estimates ( assuming all commodities contain tolerance level residues) overestimate dietary exposure. Model data used for ground water and surface water source drinking water exposure assessments result in estimates considered to be upper bound concentrations. There are no registered uses for tralkoxydim that could result in residential exposures. EPA concludes that there is a reasonable certainty that no harm will result to children from aggregate exposure to tralkoxydim residues.

F. International Tolerances There are no codex Alimentarius Commission ( Codex) or Mexican maximum residue levels for tralkoxydim at this time. [ FR Doc. 03   6823 Filed 3   20   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0057; FRL   7296   6]

Trifloxysulfuron sodium; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP   2003   0057, must be received on or before April 21, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: James A. 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. 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 ID number OPP   2003   0057. 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 VerDate Jan< 31> 2003 18: 05 Mar 20, 2003 Jkt 200001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 21MRN1. SGM 21MRN1 13925 Federal Register / Vol. 68, No. 55 / Friday, March 21, 2003 / Notices # 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/. 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. Certain types of information will not be placed in the EPA dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. 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. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed, or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and to Whom Do I Submit Comments?

You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also, include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP   2003   0057. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to opp docket@ epa. gov, Attention: Docket ID number OPP   2003   0057. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your e mail address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001, Attention: Docket ID number OPP   2003   0057. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID number OPP   2003   0057. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1.

D. How Should I Submit CBI To the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI VerDate Jan< 31> 2003 18: 05 Mar 20, 2003 Jkt 200001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 21MRN1. SGM 21MRN1 13926 Federal Register / Vol. 68, No. 55 / Friday, March 21, 2003 / Notices on disk or CD ROM, mark the outside of the disk or CD ROM as CBI, and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: March 10, 2003. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition The petitioner's summary of the pesticide petition is printed below as required by FFDCA section 408( d)( 3). The summary of the petition was prepared by Syngenta Crop Protection, Inc, and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

Syngenta Crop Protection, Inc.

PP 1F6280 EPA has received a pesticide petition ( 1F6280) from Syngenta Crop Protection, Inc., Greensboro, NC 27419 proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180, by establishing a tolerance for residues of trifloxysulfuron sodium in or on the raw agricultural commodities sugarcane at 0.01 parts per million ( ppm), cottonseed at 0.05 ppm, cotton by products at 1.0 ppm, citrus at 0.01, almond hulls at 0.01 ppm, almond nut meat at 0.01 ppm, and tomatoes at 0.01 ppm. EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry 1. Plant metabolism. The primary metabolic pathways of trifloxysulfuronsodium in plants ( cotton, sugarcane and citrus) were similar to those described for animals, with certain extensions of the pathway in plants. The metabolism of trifloxysulfuron sodium is well characterized in plants and animals and the data is adequate for tolerance setting purposes. The metabolism profile in plants and animals supports the use of an analytical enforcement method that accounts for parent trifloxysulfuronsodium The multiple other metabolites formed in plants and animals are considered of equal or lesser toxicity than parent compound. 2. Analytical method. Syngenta Crop Protection, Inc. has submitted practical analytical methodology for detecting and measuring levels of trifloxysulfuron sodium in or on raw agricultural commodities. This method is based on crop specific cleanup procedures and determination by liquid chromatography with a ultraviolet ( UV/ Vis) detector. The limit of detection ( LOD) for each analyte of this method is 2 nanograms of trifloxysulfuron sodium. The limit of quantitation ( LOQ), as demonstrated by acceptable recoveries from fortified control samples, is 0.01 ppm for each substrate. 3. Magnitude of residues. A residue program was performed with trifloxysulfuron sodium on a full geography to support use on cotton, sugarcane, citrus, and almonds. Adequate residue trials were performed to support the proposed use on tomatoes.

B. Toxicological Profile 1. Acute toxicity. Trifloxysulfuronsodium has low acute toxicity. The oral LD50 in rats is > 5,000 millgrams/ kilogram ( mg/ kg) for males and females combined. The rat dermal LD50 is > 2,000 mg/ kg and the rat inhalation LC50 is > 5.03 milligrams/ liter ( mg/ L) air. Trifloxysulfuron sodium is not a skin sensitizer in guinea pigs and is considered to have slight dermal or eye irritation in rabbits. End use formulations of Trifloxysulfuronsodium have similar low acute toxicity profiles. 2. Genotoxicity. Trifloxysulfuronsodium has been tested for its potential to induce gene mutation and chromosomal changes in five different test systems. Trifloxysulfuron sodium technical did not induce point mutations in bacteria ( Ames assay in Salmonella typhimurium or Escherichia coli) or in cultured mammalian cells ( Chinese hamster V79) and was not genotoxic in an in vitro unscheduled DNA synthesis assay in rat hepatocytes. Chromosome aberrations were not observed in an in vitro test using Chinese hamster ovary cells and there were no clastogenic or aneugenic effects on mouse bone marrow cell in vivo in a mouse micronucleus test. These studies show that trifloxysulfuronsodium is not genotoxic.

VerDate Jan< 31> 2003 18: 05 Mar 20, 2003 Jkt 200001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 21MRN1. SGM 21MRN1 13927 Federal Register / Vol. 68, No. 55 / Friday, March 21, 2003 / Notices 3. Reproductive and developmental toxicity. Data from developmental toxicity studies in the rat and rabbit and a two generation reproduction study in the rat have been considered. In rabbit ( 0, 50, 100, 250, 500 mg/ kg/ day) and rat ( 0, 30, 300, 1,000 mg/ kg/ day) teratology studies there was no evidence of teratogenicity. Maternal toxicity was seen at 500 mg/ kg/ day and 250 mg/ kg/ day as evidenced by deaths and premature sacrifices. For the control ( 50, 100, and 250 mg/ kg) groups, preimplantation losses, number of implantation sites, and postimplantation losses were not affected by treatment. The findings after fetal post mortem examination and fetal visceral examination revealed no treatment related effects. Similarly, there were no skeletal malformations in this study and the incidence of anomalies and variations were not affected by treatment. In conclusion, the no observed adverse effect levels ( NOAEL) for maternal toxicity was 100 mg/ kg/ day and the NOAEL for fetal toxicity was 250 mg/ kg/ day. There was no indication of embryotoxic, fetotoxic or teratogenic potential for trifloxysulfuron sodium in rabbits. In the rat teratology study, 300 and 1,000 mg/ kg/ day caused maternal toxicity consisting of reduced body weight and food consumption. Developmental toxicity was secondary to maternal toxicity and consisted of slightly reduced fetal body weights and an increase in minor skeletal anomalies and variations. The NOAELs for maternal and developmental toxicity were both 30 mg/ kg/ day. Trifloxysulfuron sodium was not embryotoxic, fetotoxic or teratogenic in rats when tested under the conditions of this study. In a rat multigeneration study, trifloxysulfuron sodium technical was administered in feed at concentrations of 0, 500, 1,000, 8,000 or 12,000 ppm. The dose in mg/ kg/ day spans a wide range over the duration of the study as animals gain weight and go through gestation and lactation. The ranges are 24   70, 48   137, 400   1,133, 608   1,755 for males and 32   100, 60   199, 500   1,557, 792   2,374 for females at the 500, 1,000, 8,000, and 12,000 ppm dietary level, respectively. Trifloxysulfuron sodium had no effect on reproductive parameters. Parental body weight gain and food consumption were reduced at 12,000 ppm in both sexes and at 8,000 ppm in males only. In addition, there was an increased relative liver weight and an increased incidence of hepatocellular hypertrophy at 12,000 ppm in both sexes of adults and at 8,000 ppm in adult males only. Offspring body weights were reduced in males and females greater than or equal to 8,000 ppm. In conclusion, the NOAEL for systemic toxicity in both sexes and both generations was 1,000 ppm. The mean dose in mg/ kg/ day for all weekly means for both sexes, both generations, all time points at this dietary level was 83.4 mg/ kg/ day. There were no effects on the reproductive parameters and the NOAEL for reproductive toxicity was > 12,000 ppm. Offspring effects were observed only at dose levels that produced parental toxicity. Thus, there is no evidence that developing offspring are more sensitive than adults to the effects of trifloxysulfuron sodium, and it is concluded, that trifloxysulfuronsodium does not cause developmental or reproductive toxicity. 4. Subchronic toxicity. Trifloxysulfuron sodium technical was evaluated in a number of subchronic studies. In a 3   month rat feeding study the NOAEL was 65.7 mg/ kg with hematologic and liver effects noted. In a 3   month mouse feeding study, the NOAEL was 67.9 mg/ kg. Effects seen were adaptive liver effects. In a 3   month feeding study in dogs the NOAEL was 19.6 mg/ kg and hematopoietic and liver effects were seen. In a 28   day dermal ( rat) study, the NOAEL was 100 mg/ kg. In this study only body weight effects were noted, and only occurred at 1,000 mg/ kg. 5. Chronic toxicity. Trifloxysulfuronsodium technical was not oncogenic in rats or mice. In a 12   month feeding study in dogs fed diets containing trifloxysulfuron sodium that resulted in average ( sexes combined) daily test substance intakes of 0, 1.67, 6.71, 15.0, 48.2 or 122 mg/ kg/ day, all animals survived. In life observations, food consumption, eye and neurological examinations, and urine profiles were not affected by treatment. Macroscopic and microscopic examinations revealed no findings that were considered to be treatment related and indicative of systemic toxicity. The body weight gain was decreased by 16% in males at 122 mg/ kg/ day. The 33% decrease at 48.2 mg/ kg/ day was mainly due to one male that gained significantly less weight than the other animals of this group. There was a tendency for a decrease in the erythrocyte count, hemoglobin concentration and hematocrit for both sexes at 122 mg/ kg/ day at the end of treatment, and for males throughout the treatment period. In female dogs treated with 48.2 and 122 mg/ kg/ day, the mean absolute and relative liver weights were increased, and a tendency for an increase in relative liver weight was noted for males at the same dose levels. The maximum tolerance dose ( MTD) was achieved at 122 mg/ kg/ day based on the decrease in the body weight gain in males at 48.2 and 122 mg/ kg/ day. Administration of trifloxysulfuronsodium to dogs for 12 months caused a tendency for decrease in red blood cell parameters in both sexes at 122 mg/ kg/ day. There was neither histopathological nor functional evidence for compound related neurotoxicity. Based on the effects at 48.2 and 122 mg/ kg/ day, the NOAEL was established at 15.0 mg/ kg/ day for males and 14.9 mg/ kg/ day for females. In an 18   month oncogenicity study, mice were fed diets containing trifloxysulfuron sodium that resulted in average ( sexes combined) daily test substance intakes of 0, 5.84, 24.3, 116, and 836 mg/ kg/ day. Treatment had no adverse effect on appearance or behavior. Survival in treated animals was comparable to controls. There were no effects on organ weights, and there were no macroscopic or microscopic findings indicative of treatment related systemic toxicity. Trifloxysulfuronsodium was not carcinogenic in the mouse. Body weight gain in females at 836 mg/ kg/ day was decreased by 21% compared to controls after 3 months and 16% after 18 months. Food consumption was decreased in this group by 8%. The MTD was achieved at 836 mg/ kg/ day based on a decrease in body weight gain of greater than 15% throughout the study. Trifloxysulfuronsodium was not carcinogenic in the mouse. Based on the findings at 836 mg/ kg/ day, the NOAEL for chronic toxicity was established at 121 mg/ kg/ day for males and 112 mg/ kg/ day for females. In a 2   year chronic toxicity and carcinogenicity study, rats were fed diets containing trifloxysulfuronsodium that resulted in average ( sexes combined) daily test substance intakes of 0, 2.08, 22.0, 91.0 or 464 mg/ kg/ day. Clinical signs, survival, eye examinations, blood chemistry, urinalysis, and water consumption were not adversely affected by treatment. Survival in high dose females was greater than 80%, than in controls of 60%. There were no treatment related findings at the 12   month interim or terminal necropsy. A treatment related decrease in body weight gain ( 17% decrease compared to controls) was seen in both females and males at 464 mg/ kg/ day ( 10,000 ppm), which was considered to be the maximum tolerated dose ( MTD). Overall food consumption was decreased by 6% in males or 9% in females at 464 mg/ kg/ day. At the interim and terminal VerDate Jan< 31> 2003 18: 05 Mar 20, 2003 Jkt 200001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 21MRN1. SGM 21MRN1 13928 Federal Register / Vol. 68, No. 55 / Friday, March 21, 2003 / Notices sacrifices, mean carcass weights were lower in males ( 9% and 13%, respectively) and females ( 17% and 12%, respectively) for the 464 mg/ kg/ day group. At terminal sacrifice, the testes to body weight ratio was increased by 19% in the 464 mg/ kg/ day group. Microscopical examination revealed a non dose responsive increase in the incidence of kidney tubular atrophy in the two top dose groups of female rats, and an increase in Leydig cell hyperplasia in high dose males only. Both treatment related lesions occurred late in age/ treatment, and were not seen in animals sacrificed in the initial year of the study. Neither lesion showed an increase in severity ( only incidence) or a progression of the lesion. Both lesions are commonly seen in high incidence in aged control rats; 26% of control females showed renal tubular atrophy, and 22% of control males showed Leydig cell hyperplasia. The control incidence in 10 studies was less than 10%, suggesting that the animals in this study were particularly susceptible to this lesion. There were no data from other measured parameters in this study that suggest kidney or testis as target organs, therefore indicating that these lesions are high dose, long term effects. In conclusion, the MTD was reached or exceeded at 464 mg/ kg/ day for the 2   year rat feeding study. The NOAEL in males was 82.6 mg/ kg/ day based on the increased incidence of Leydig cell hyperplasia, and 23.7 mg/ kg/ day in females based on the increased incidence of kidney tubular atrophy. There was no evidence of a carcinogenic effect after 2 years of treatment with trifloxysulfuron sodium in rats. 6. Animal metabolism. Metabolism in rats proceeded primarily via three concurrent metabolic pathways ( typical sulfonylurea chemistry: Oxidative odemethylation hydroxylation of the pyrimidine ring and Smiles rearrangement of the sulfonylurea. Hydrolysis of the sulfonylurea and oxidative O demethylation are minor pathways in the rat. Parent compound was the major residue in the rat. The metabolite pattern in urine and feces extracts of dogs is similar to that of rats. Trifloxysulfuron sodium was the major component detected in extracts of urine and feces for dogs, as in the rats. In hens and goats, the metabolite profile was very similar to that observed in the rat. 7. Metabolite toxicology. The metabolism profile for trifloxysulfuronsodium supports the use of an analytical enforcement method that accounts for parent trifloxysulfuron sodium. Other metabolites are considered of equal or lesser toxicity than parent compound. 8. Endocrine disruption. Trifloxysulfuron sodium does not belong to a class of chemicals known or suspected of having adverse effects on the endocrine system. There is no evidence that trifloxysulfuron sodium has any effect on endocrine function in development or reproduction studies. Furthermore, histological investigation of endocrine organs in chronic dog, mouse, and rat studies did not indicate that the endocrine system is targeted by trifloxysulfuron sodium. 9. Neurotoxicity. In an acute range finding neurotoxicity study in which rats received a single oral dose of 2,000 or 3,500 mg/ kg trifloxysulfuron sodium, there were no effects on clinical signs, body weight and food consumption, or parameters in an abbreviated functional observational battery ( FOB). Therefore, the time to peak effect for FOB and motor activity testing was based on a blood kinetic study. In this study, trifloxysulfuron sodium induced peak plasma levels at 1   2 hours post dose, and levels were almost zero at 24 hours. In an acute neurotoxicity study in rats, trifloxysulfuron sodium was administered by gavage at 0 or 2,000 mg/ kg. Mortality, body weight development and food consumption were not affected by treatment. Neither clinical signs nor changes in observation and functional test conducted as part of the FOB were observed. Reduced horizontal and vertical motor activity were observed in males and females only at the time of peak effect ( 1   2 hours post dosing). There were no persistent signs of toxicity and no histopathological evidence of neurotoxicity. In a second acute neurotoxicity study in rats, trifloxysulfuron sodium was administered by gavage at 0, 200, 600 and 2,000 mg/ kg. Mortality, body weight development and food consumption were not affected by treatment. There were no effects on clinical signs or on parameters in the FOB. During the peak plasma period ( 1   2 hours post dosing), motor activity parameters of the males were comparable to the control while females tended to be slightly less active. Based on the results of this study, Trifloxysulfuron sodium was devoid of neurotoxic effects. Due to the slightly reduced motor activity in top dose females, the NOAEL was established at 600 mg/ kg. In a 90   day subchronic neurotoxicity study in rats, trifloxysulfuron sodium was not neurotoxic when administered in the diet for 13 weeks at concentrations resulting in average daily test substance intakes of 0, 112, 472, or 967 mg/ kg/ day for males or 0, 134, 553 or 1,128 mg/ kg/ day for females. There were no treatment related deaths or clinical signs. Effects on body weight development and food consumption indicated systemic toxicity in males at doses 472 mg/ kg/ day and in females at 1,128 mg/ kg/ day. There were no treatment related neurobehavioral or motor activity effects, no macroscopic findings, and no microscopic findings in central or peripheral nervous tissue. In the absence of any functional or morphological changes in the nervous system at any of the dose levels tested, trifloxysulfuron sodium is considered devoid of neurotoxic potential when administered to rats for 90 days. Based on body weight effects, the NOAEL was established at 112 mg/ kg/ day for male rats and 553 mg/ kg/ day for female rats.

C. Aggregate Exposure 1. Dietary exposure. Dietary exposure from trifloxysulfuron sodium potentially exists through both food commodities and drinking water. Each exposure pathway is addressed below. i. Food. Chronic dietary exposure to trifloxysulfuron sodium was estimated based on proposed tolerance based residue values and the assumption that 100% of all planted acres were treated. The assessment included cotton, processed cotton fractions, sugarcane and associated processed commodities, citrus, almonds and tomatoes. Chronic exposure for all populations was compared to a reference dose ( RfD) of 0.15 milligrams/ kilogram/ body weight/ day ( mg/ kg/ bwt/ day) based on a no observed adverse effect level ( NOAEL) of 14.9 mg/ kg/ bwt/ day from a 1   year study in dogs and a 100X uncertainty factor. The analysis was conducted using the dietary exposure evaluation model ( DEEMTM) and the USDA's 1994   96 Continuing Survey of Food Intake by Individuals ( CSFII). Secondary residues in animal commodities were not considered in this evaluation since calculations showed that transfer from livestock and poultry was minimal and would result in residue levels significantly below current analytical method capabilities. Chronic exposure to trifloxysulfuron sodium was found to be essentially zero with less than 0.1% of the RfD utilized for all populations. These exposure calculations are conservative in that 100% of the crop was assumed as treated and tolerancebased residue levels were entered into the dietary model. Acute dietary assessments were conducted for trifloxysulfuron sodium using proposed tolerance based residue values and the assumption that 100% of all planted acres were treated. The assessment included cotton, processed cotton fractions, sugarcane and VerDate Jan< 31> 2003 18: 05 Mar 20, 2003 Jkt 200001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 21MRN1. SGM 21MRN1 13929 Federal Register / Vol. 68, No. 55 / Friday, March 21, 2003 / Notices associated processed commodities, citrus, almonds and tomatoes. Acute exposure to the female population ( 13   50 years old) was compared to a RfD of 0.30 mg/ kg/ bwt/ day based on a NOAEL of 30 mg/ kg/ bwt/ day from a rat teratology study and a 100X uncertainty factor. Acute exposure to the general population and all other population subgroups ( including infants and children) was compared to a RfD of 6.0 mg/ kg/ bwt/ day based on a NOAEL of 600 mg/ kg/ bwt/ day from an acute neurotoxicity study in rats and a 100X uncertainty factor. The analyses were conducted using the Dietary Exposure Evaluation Model ( DEEMTM) from Novigen Sciences and the USDA's 1994   96 CSFII. Secondary residues in animal commodities were not considered in this evaluation since calculations showed that transfer from livestock and poultry was minimal and would result in residue levels significantly below current analytical method capabilities. The acute exposures are presented at the 99.9th percentile of exposure although the Agency accepts the 95th percentile when conservative Tier I estimates are made ( tolerance based residues and 100% crop treated assumptions). Even at the 99.9th percentile, exposure and subsequent risk was found to be 0.2% of the acute reference dose ( aRfD) for the female population ( 13   19 years not pregnant or nursing) and essentially zero with less than 0.1% of the aRfD utilized for all other populations. These exposure calculations are conservative in that 100% of the crop was assumed as treated, and tolerance based residue levels were entered into the dietary model. ii. Drinking water. For chronic exposure in water, the estimated maximum concentrations of trifloxysulfuron sodium in surface water at day 56/ 3 was 0.35 parts per billion ( ppb) generic expected environmental concentration ( GENEEC) ( sugarcane) and 0.051 ppb in ground water ( SCIGROW ( turf). The chronic drinking water levels of concern ( DWLOC) values were calculated and compared to these estimated water concentrations. From the chronic dietary exposure analysis, an exposure estimate of 0.000015 mg/ kg/ day was determined for the U. S. population and less than or equal to 0.000037 mg/ kg/ day for all subgroups. Using this information, chronic drinking water levels of concern ( DWLOCchronic) were calculated for trifloxysulfuronsodium The trifloxysulfuron sodium estimated ground water ( 0.051 ppb) and surface water ( 0.35 ppb) concentrations do not exceed the calculated chronic DWLOC values ( µ g/ L): 1,500 to 5,250). Therefore, trifloxysulfuron sodium exposures would not exceed the exposure allowable by the chronic risk cup. The estimated maximum proposed rates for the `` worst case'' estimation of the proposed use concentrations of trifloxysulfuron sodium in surface water at Peak Day   0 was 2.56 ppb GENEEC ( sugarcane) and 0.051 ppb in ground water ( SCI GROW) ( turf). The acute DWLOC values were calculated and compared to these estimated water concentrations. From the acute dietary exposure analysis, the lowest margin of exposure ( MOE) from the use of trifloxysulfuronsodium was at the 95th percentile for the U. S. population and all population subgroups. This indicates a food exposure of less than or equal to 0.00016 mg/ kg/ day for all populations. Based on the EPA's `` Interim Guidance for Conducting Drinking Water Exposure and Risk Assessments'' document ( draft 12/ 2/ 97), acute drinking water levels of concern ( DWLOCacute) were calculated for trifloxysulfuron sodium. The lowest acceptable MOE for any pesticide is 100. This value was used in the DWLOC calculations. Based on this analysis, trifloxysulfuron sodium estimated surface water ( 2.56 ppb) and ground water ( 0.051 ppb) concentrations, for sugarcane, do not exceed the calculated acute DWLOC values ( µ g/ L: 8997 to 209,965). Therefore, trifloxysulfuronsodium exposures would not exceed the exposure allowable by the risk cup. 2. Non dietary exposure. The acute MOE for children ingesting pesticidetreated turf exceeds 190 million. The risk estimate does not exceed the level of concern ( MOE = 100), indicating there are no oral exposure concerns for children ingesting trifloxysulfuronsodium treated turf.

D. Cumulative Effects The potential for cumulative effects of trifloxysulfuron sodium and other substances that have a common mechanism of toxicity has also been considered. Trifloxysulfuron sodium is a member of the class of herbicides designated as sulfonylureas. There is no reliable information to indicate that toxic effects produced by trifloxysulfuron sodium would be cumulative with those of any other chemical including another pesticide. Therefore, Syngenta believes it is appropriate to consider only the potential risks of trifloxysulfuronsodium in an aggregate risk assessment. E. Safety Determination 1. U. S. population. In assessing the potential for additional sensitivity of infants and children to residues of trifloxysulfuron sodium, data from developmental toxicity studies in the rat and rabbit and a two generation reproduction study in the rat have been considered. 2. Infants and children. In assessing the potential for additional sensitivity of infants and children to residues of trifloxysulfuron sodium, data from developmental toxicity studies in the rat and rabbit and a two generation reproduction study in the rat have been considered. In rabbit ( 0, 50, 100, 250, 500 mg/ kg/ day) and rat ( 0, 30, 300, 1,000 mg/ kg/ day) teratology studies there was no evidence of teratogenicity. Delayed fetal development was apparent only at maternally toxic doses of trifloxysulfuron sodium technical in rats. In rabbits, 500 mg/ kg/ day was clearly toxic to does and at 250 mg/ kg/ day, lesser toxicity was seen. For the control ( 50, 100, and 250 mg/ kg) groups, pre implantation losses, number of implantation sites, and postimplantation losses were not affected by treatment. The findings after fetal post mortem examination and fetal visceral examination revealed no treatment related effects. Similarly, there were no skeletal malformations in this study and the incidence of anomalies and variations were not affected by treatment. The no observed adverse effect levels ( NOAEL) for maternal toxicity was 100 mg/ kg/ day and the NOAEL for fetal toxicity was 250 mg/ kg/ day. There was no indication of embryotoxic, fetotoxic, or teratogenic potential for trifloxysulfuron sodium in rabbits. In the rat teratology study developmental toxicity was secondary to maternal toxicity and consisted of slightly reduced fetal body weights and an increase in minor skeletal anomalies and variations. The NOAELs for maternal and developmental toxicity were both 30 mg/ kg/ day. Trifloxysulfuron sodium was not embryotoxic, fetotoxic, or teratogenic in rats when tested under the conditions of this study. In a rat multigeneration study, trifloxysulfuron sodium had no effect on reproductive parameters. The NOAEL for systemic toxicity in both sexes and both generations was 1,000 ppm. The mean dose in mg/ kg/ day for all weekly means for both sexes, both generations, all time points at this dietary level was 83.4 mg/ kg/ day. There were no effects on the reproductive parameters and the NOAEL for VerDate Jan< 31> 2003 18: 05 Mar 20, 2003 Jkt 200001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 21MRN1. SGM 21MRN1 13930 Federal Register / Vol. 68, No. 55 / Friday, March 21, 2003 / Notices reproductive toxicity was > 12,000 ppm. Offspring effects were not observed at dose levels that did not produce parental toxicity. There is no evidence that developing offspring are more sensitive than adults to the effects of trifloxysulfuron sodium. FFDCA section 408 provides that EPA may apply an additional safety factor for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base. Based on the current toxicological requirements, the data base for trifloxysulfuronsodium relative to prenatal and postnatal effects for children is complete. Further, for trifloxysulfuronsodium the developmental studies showed no increased sensitivity in fetuses as compared to maternal animals following in utero exposures in rats and rabbits, and no increased sensitivity in pups as compared to the adults in the multi generation reproductive toxicity study. Therefore, it is concluded that an additional uncertainty factor is not warranted to protect the health of infants and children and that a RfD of 0.15 mg/ kg/ day is appropriate for assessing aggregate risk to infants and children of trifloxysulfuron sodium. Assuming tolerance level residues and 100% of crops treated, less than 0.1% of the trifloxysulfuron sodium chronic RfD is utilized in the population subgroup all infants (> 1 year old). Therefore, based on the completeness and reliability of the toxicity data base, Syngenta concludes that there is reasonable certainty that no harm will result to infants and children from aggregate exposure to trifloxysulfuronsodium residues.

F. International Tolerances There are no Codex MRLs established for residues of trifloxysulfuron sodium on cottonseed, cotton byproducts, citrus, almonds, sugarcane or tomatoes.

[ FR Doc. 03   6822 Filed 3   20   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ FRL   7471   2]

Strategic Plan for North American Cooperation in the Conservation of Biodiversity   Draft for Public Review AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice of availability.

SUMMARY: Comments are requested on the final draft of the Strategic Plan for North American Cooperation in the Conservation of Biodiversity ( Strategic Plan). The Strategic Plan has been prepared by the Secretariat of the Commission for Environmental Cooperation ( CEC), under the North American Agreement on Environmental Cooperation, in coordination with representatives from Canada, Mexico, and the United States. The Strategic Plan will be used to guide the CEC Council, its Biodiversity Conservation Working Group, and the CEC Secretariat in their work with stakeholders in cooperatively defining and implementing mutually beneficial biodiversity conservation activities in North America. Comments will be categorized and responses will be developed for each category. Responses to comment categories will be published in the Federal Register within 45 days of the closing date for comments. Changes to the final draft of the Strategic Plan, to be made in response to comments, will be discussed with representatives from Canada, Mexico and the CEC Secretariat.

DATES: Written comments will be accepted for 30 calendar days. Please submit or postmark written comments on the final draft document by April 21, 2003.

ADDRESSES: Comments should be sent to Patrick Cotter, Office of International Affairs ( 2260R), U. S. Environmental Protection Agency, and 1300 Pennsylvania Avenue, NW., Washington, DC 20004. Faxed comments should be sent to Patrick Cotter at ( 202) 565   2409. Comments can also be sent by email to Cotter. Patrick@ epa. gov. Access to the Document: The complete text of the final draft document, in English, is available through a link on the EPA Office of International Affair's Web site at: http:// www. epa. gov/ international/ trade/ index. html, or you may access the document directly on the CEC's Web site at: http:// www. cec. org/ pubs_ docs/ documents/ index. cfm? varlan= english& ID= 1088. Copies of the final draft document can be obtained in electronic or hard copy format by request from Patrick Cotter at the above mailing address, email address or by calling ( 202) 564   6414.

FOR FURTHER INFORMATION CONTACT: Patrick Cotter by telephone at ( 202) 564   6414 or by email at Cotter. Patrick@ epa. gov. Dated: March 17, 2003. Dona M. Harris, Acting Director, Office of Management Operations, Office of International Affairs. [ FR Doc. 03   6818 Filed 3   20   03; 8: 45 am]

BILLING CODE 6560   50   P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [ Docket No. 02N   0281]

Agency Information Collection Activities; Announcement of OMB Approval; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration ( FDA) is announcing that a collection of information entitled `` General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions'' has been approved by the Office of Management and Budget ( OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of Information Resources Management ( HFA   250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301   827   4659.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 18, 2002 ( 67 FR 77498), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U. S. C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910   0183. The approval expires on March 31, 2006. A copy of the supporting statement for this information collection is available on the Internet at http:// www. fda. gov/ ohrms/ dockets.

Dated: March 14, 2003. William K. Hubbard, Associate Commissioner for Policy and Planning. [ FR Doc. 03   6739 Filed 3   20   03; 8: 45 am]

BILLING CODE 4160   01   S VerDate Jan< 31> 2003 18: 05 Mar 20, 2003 Jkt 200001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 21MRN1. SGM 21MRN1