[Federal Register: May 7, 2008 (Volume 73, Number 89)]
[Notices]
[Page 25816-25818]
[DOCID:fr07my08-143]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57746; File No. SR-NYSE-2008-34]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to Exchange Rule 36 (Communication Between Exchange and
Exchange Members' Offices)

April 30, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 29, 2008, the New York Stock Exchange LLC (``NYSE'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been substantially prepared by the
Exchange. The Exchange filed the proposed rule change pursuant to
Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(6) thereunder,\4\
which renders the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange seeks to extend its current portable phone pilot (the
``Pilot'') operating pursuant to Exchange Rule 36 from its scheduled
April 30, 2008 expiration date to no later than the approval of SR-
NYSE-2008-20 \5\ or June 30, 2008, the earlier thereof.
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    \5\ See Securities Exchange Act Release No. 57611 (April 3,
2008), 73 FR 19274 (April 9, 2008). The comment period expires on
April 30, 2008.
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. 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 seeks to extend the Pilot operating pursuant to
Exchange Rule 36 from the Pilot's scheduled April 30, 2008 expiration
date to no later than the approval of SR-NYSE-2008-20 or June 30, 2008,
the earlier thereof.
    Pursuant to the Pilot, Floor brokers and Registered Competitive
Market Makers (``RCMMs'') are permitted to use an Exchange authorized
and provided portable telephone on the Exchange Floor provided certain
conditions are met. Such usage has been permitted on a pilot basis. The
current Pilot expires on April 30, 2008. Through the rule filing SR-
NYSE-2008-20, the Exchange seeks to have the amendment to Exchange Rule
36 made permanent.

Exchange filing SR-NYSE-2008-20 was noticed for comment in the Federal
Register by the Commission on April 9, 2008. The comment period ends on
April 30, 2008. In order to avoid a lapse of the operation of the Pilot
pending the approval of SR-NYSE-2008-20 by the Commission, the Exchange
proposes in the instant filing to extend the operation of the Pilot
either for an additional two months until June 30, 2008, or until the
approval of SR-NYSE-2008-20, whichever occurs first.

Background

    The Commission originally approved the Pilot to be implemented for
a six-month period \6\ beginning no later than June 23, 2003.\7\ Since
the inception of the Pilot, the Exchange has extended the Pilot nine
times, with the current Pilot expiring on April 30, 2008.\8\
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    \6\ See Securities Exchange Act Release No. 47671 (April 11,
2003), 68 FR 19048 (April 17, 2003) (SR-NYSE-2002-11).
    \7\ See Securities Exchange Act Release No. 47992 (June 5,
2003), 68 FR 35047 (June 11, 2003) (SR-NYSE-2003-19) (delaying the
implementation date for portable phones from on or about May 1,
2003, to no later than June 23, 2003).
    \8\ See Securities Exchange Act Release Nos. 48919 (December 12,
2003), 68 FR 70853 (December 19, 2003) (SR-NYSE-2003-38) (extending
the Pilot for an additional six months ending on June 16, 2004);
49954 (July 1, 2004), 69 FR 41323 (July 8, 2004) (SR-NYSE-2004-30)
(extending the Pilot for an additional five months ending on
November 30, 2004); 50777 (December 1, 2004), 69 FR 71090 (December
8, 2004) (SR-NYSE-2004-67) (extending the Pilot for an additional
four months ending March 31, 2005); 51464 (March 31, 2005), 70 FR
17746 (April 7, 2005) (SR-NYSE-2005-20) (extending the Pilot for
additional four months ending July 31, 2005); 52188 (August 1,
2005), 70 FR 46252 (August 9, 2005) (SR-NYSE-2005-53) (extending the
Pilot for an additional six months ending January 31, 2006); 53277
(February 13, 2006), 71 FR 8877 (February 21, 2006) (SR-NYSE-2006-
03) (extending the Pilot for an additional six months ending July
31, 2006); 54276 (August 4, 2006), 71 FR 45885 (August 10, 2006)
(SR-NYSE-2006-55) (extending the Pilot for an additional six months
ending January 31, 2007); 55218 (January 31, 2007), 72 FR 6025
(February 8, 2007) (SR-NYSE-2007-05) (extending the Pilot for an
additional twelve months ending January 31, 2008); and 57249
(January 31, 2008), 73 FR 7024 (February 6, 2008) (SR-NYSE-2008-10)
(extending the Pilot for an additional three months ending April 30,
2008). Also, the Exchange has incorporated RCMMs into the Pilot and
subsequently amended the Pilot to allow RCMMs to use an Exchange
authorized and provided portable telephone on the Exchange Floor to
call to and receive calls from their upstairs offices, the upstairs
offices of their clearing firm, and their booth locations on the
NYSE Floor. See Securities Exchange Act Release Nos. 53213 (February
2, 2006), 71 FR 7103 (February 10, 2006) (SR-NYSE-2005-80) and 54215
(July 26, 2006), 71 FR 43551 (August 1, 2006) (SR-NYSE-2006-51).
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    Exchange Rule 36 governs the establishment of telephone or
electronic communications between the Exchange's Trading Floor and any
other location. Prior to the Pilot, Exchange Rule 36 prohibited the use
of portable telephone communication between the Trading Floor and any
off-Floor location.
    During the operation of the Pilot, Floor brokers and RCMMs may use
Exchange authorized and issued portable telephones on the Floor. Floor
brokers are permitted to engage in direct voice communication from the
point of sale to an off-Floor location, such as a member firm's trading
desk or the office of one of the broker's customers. Such
communications permit the broker to accept orders consistent with
Exchange rules governing the entry of orders on the NYSE Floor, provide
status and oral execution reports as to orders previously received, as
well as ``market look'' observations as have historically been
routinely transmitted from a broker's booth location.
    Both incoming and outgoing calls are allowed, provided the
requirements of all other Exchange rules have been met. A Floor broker
is not permitted to represent and execute any order received as a
result of such voice communication unless the order is first properly
recorded by the member and entered into the Exchange's Front End
Systemic Capture (``FESC'') electronic database (Exchange Rule
123(e)).\9\ In addition, Exchange rules require that any Floor broker
receiving orders from the public over portable phones must be properly
qualified to engage in such direct access business under Exchange Rules
342 and 345, among others.\10\
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    \9\ See Securities Exchange Act Release No. 43689 (December 7,
2000), 65 FR 79145 (December 18, 2000) (SR-NYSE-98-25). See also
Securities Exchange Act Release No. 44943 (October 16, 2001), 66 FR
53820 (October 24, 2001) (SR-NYSE-2001-39) (discussing certain
exceptions to FESC, such as orders to offset an error, or a bona
fide arbitrage, which may be entered within 60 seconds after a trade
is executed).
    \10\ For more information regarding Exchange requirements for
conducting a public business on the Exchange Floor, see Information
Memos 01-41 (November 21, 2001), 01-18 (July 11, 2001) (available at
http://www.nyse.com/regulation/) and 91-25 (July 8, 1991).
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    The Pilot also allows RCMMs to use an Exchange authorized portable
phone solely to call and receive calls from their booths on the Floor,
to communicate with their or their member organizations' off-Floor
office, and to communicate with the off-Floor office of their clearing
member organization to enter off-Floor orders and to discuss matters
related to the clearance and settlement of transactions, provided the
off-Floor office uses a wired telephone line for these discussions.
RCMMs, who trade for their own accounts on the Floor subject to the
requirements of NYSE Rule 107A, are currently not allowed to use a
portable phone to conduct any agency business.\11\ For both RCMMs and
Floor brokers, use of a portable telephone on the Exchange Floor other
than one authorized and issued by the Exchange is prohibited.
    Specialists are subject to separate restrictions in Exchange Rule
36 on their ability to engage in voice communications from the
specialist post to an off-Floor location.\12\ The Pilot does not apply
to specialists, who would continue to be prohibited from speaking from
the post to upstairs trading desks or customers.\13\
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    \11\ Allowing RCMMs acting as Floor brokers to use portable
phones would involve further discussions with the Commission and
would be the subject of a separate filing with the Commission.
    \12\ See Securities Exchange Act Release No. 46560 (September
26, 2002), 67 FR 62088 (October 3, 2002) (SR-NYSE-00-31) (discussing
restrictions on specialists' communications from the post).
    \13\ Exchange Rule 36.30 provides that, with the approval of the
Exchange, a specialist unit may maintain a telephone line at its
stock trading post location to the off-Floor offices of the
specialist unit or the unit's clearing firm. Such telephone
connection shall not be used for the purpose of transmitting to the
Floor orders for the purchase or sale of securities, but may be used
to enter options or futures hedging orders through the unit's off-
Floor office or the unit's clearing firm, or through a member (on
the Floor) of an options or futures exchange.
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    The Exchange believes that the Pilot is operating successfully in
that there is a reasonable degree of usage of portable phones. During
the period of January 31, 2008 through April 29, 2008, there have been
no significant regulatory concerns identified with their usage.\14\
Moreover, there have been no administrative or technical problems,
other than routine telephone maintenance issues, that have resulted
from the operation of the Pilot over the past few months.
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    \14\ The Exchange has received records of incoming and outgoing
telephone calls from January 31, 2008, through March 31, 2008, for
Floor brokers and RCMMs and will continue to receive records of such
telephone calls on a monthly basis.
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Conclusion

    The Exchange proposes to extend the operation of the current Pilot
for an additional two months to June 30, 2008 or until the approval of
SR-NYSE-2008-20. The Exchange believes that the approval of the Pilot's
continuation for the earlier of an additional two months or until the
approval of SR-NYSE-2008-20 will enable the Exchange to continue to
provide more direct, efficient access to its trading crowds and
customers, increase the speed of order transmittal and trade execution,
and provide an enhanced level of service to customers in an
increasingly competitive environment. Therefore the Exchange believes
it is appropriate to extend the Pilot to expire no later than the
approval of the pending filing to

make the amendment to Exchange Rule 36 permanent or to June 30, 2008.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with,
and furthers the objectives of, Section 6(b)(5) of the Act,\15\ in that
it is designed to prevent fraudulent and manipulative practices, to
promote just and equitable principles of trade, to remove impediments
to, and perfect the mechanisms of, a free and open market and a
national market system, and, in general, to protect investors and the
public interest.
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    \15\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

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

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate if consistent with
the protection of investors and the public interest, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \16\ and Rule 19b-
4(f)(6) thereunder.\17\ At any time within 60 days of the filing of the
proposed rule change, the Commission may summarily abrogate such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
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    \16\ 15 U.S.C. 78s(b)(3)(A).
    \17\ 17 CFR 240.19b-4(f)(6).
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    The Exchange requests that the Commission waive the five-day pre-
filing period and 30-day operative period under Rule 19b-
4(f)(6)(iii).\18\ The Commission has waived the five-day pre-filing
requirement for this proposed rule change. Additionally, the Exchange
believes that the continuation of the Pilot is in the public interest
as it will avoid inconvenience and interruption to the public. The
Commission believes that it is consistent with the protection of
investors and the public interest to waive the 30-day operative delay
and make this proposed rule change immediately effective upon
filing.\19\ The Commission believes that the waiver of the 30-day
operative delay will allow the Exchange to continue, without
interruption, the existing operation of its Pilot until the earlier of
the approval of SR-NYSE-2008-20 or June 30, 2008.
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    \18\ 17 CFR 240.19b-4(f)(6)(iii).
    \19\ For purposes only of waiving the 30-day operative delay of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. 15 U.S.C.
78c(f).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:
    Electronic comments:
     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2008-34 on the subject line.
    Paper comments:
     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-NYSE-2008-34. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2008-34 and should be
submitted on or before May 28, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
Florence E. Harmon,
Deputy Secretary.
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    \20\ 17 CFR 200.30-3(a)(12).
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 [FR Doc. E8-9995 Filed 5-6-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: September 24, 2008 (Volume 73, Number 186)]
[Rules and Regulations]
[Page 54973-54977]
[DOCID:fr24se08-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0175; FRL-8382-3]

Pesticides; Food Packaging Treated with a Pesticide

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This final rule excepts food packaging materials (e.g. paper
and paperboard, coatings, adhesives, and polymers) from the definitions
of ``pesticide chemical'' and ``pesticide chemical residue'' under the
Federal Food Drug and Cosmetic Act (FFDCA) section 201(q), when such
food packaging materials have been treated with a pesticide regulated
under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
This final rule expands the scope of the current exception which
applies only to food packaging impregnated with an insect repellent -
one type of pesticide. This final rule, as with the rule it amends,
only applies to the food packaging materials themselves; it does not
otherwise limit EPA's FFDCA jurisdiction over the pesticidal substances
in or on such products or limit FDA's jurisdiction over substances
subject to FDA regulation as food additives. This rule eliminates
duplicative FFDCA jurisdiction and economizes federal government
resources while continuing to protect human health and the environment.
It is important to note that under the Federal Insecticide, Fungicide
and Rodenticide Act (FIFRA), EPA will continue to regulate the food
packaging as an inert ingredient of the pesticide product and regulate
the pesticide active ingredient in the treated food packaging under
both FIFRA and the FFDCA (except as otherwise provided by statute). The
text of this final rule is identical to a direct final rule EPA issued
on December 6, 2006. EPA received several comments opposing that direct
final rule and therefore withdrew the rule on February 2, 2007,
consistent with EPA policy. EPA issued a subsequent proposed rule on
April 6, 2007 for additional public comment.

DATES: This final rule is effective September 24, 2008.

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0175. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov.

Although listed in the index, some information is not publicly
available, e.g., Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available in the electronic docket at
http://www.regulations.gov, or, if only available in hard copy, at the
OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Cheryl Greene, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address: greene.cheryl @epa.gov.

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

    You may be potentially affected by this action if you are a
manufacturer/wholesaler of sanitary food packaging products or are a
pesticide manufacturer. Potentially affected entities may include, but
are not limited to:
     Pesticide manufacturing (NAICS 32532).
     Food packaging manufacturers (NAICS 32222).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in 40 CFR 180.4. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

II. Background

A. What Action is the Agency Taking?

    EPA has received applications for the registration of pesticides
under FIFRA that, as proposed, will be applied to food packaging
materials. These pesticides are generally intended to function as
alternatives to more costly and more toxic applications of insecticides
in food storage and retail establishments. The regulatory framework for
this use of pesticides raises a number of complex jurisdictional issues
for EPA and FDA\1\.
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    \1\ This final rule does not include within its scope substances
which may be regulated as pesticides under FIFRA that are used to
prevent, destroy, repel or mitigate microorganisms when such
substances are included for such use in or are applied for such use
on food packaging (without regard to whether the substances are
intended to have an ongoing effect on any portion of the packaging)
(see FFDCA section 201(q)(1)(B)(ii) which excludes such substances
from the definition of ``pesticide chemical''). Because such
substances are already excluded from the definition of pesticide
chemical residue, it is unnecessary to address these substances in
this rule.
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    Because the treated packaging materials will be sold to food
distributors for the purpose of controlling pest infestations, as well
as for packaging food, the pesticide-treated food packaging materials
will be subject to the pesticide product registration requirements of
section 3 of FIFRA. Under FIFRA, the components of pesticides are
either active ingredients or inert ingredients. Active ingredients are
those which, among other things, will ``prevent, destroy, repel or
mitigate any pest.'' (FIFRA section 2(a)) Inert ingredients are
ingredients ``which [are] not active.'' (FIFRA section 2(m)). Thus, the
components of food packaging (paperboards, coatings, etc.) become inert
ingredients of a pesticide product under FIFRA whenever the food
packaging is treated with a pesticide active ingredient and is
distributed or sold with the purpose of controlling pests\2\.
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    \2\ It is important to understand that this final rule only
applies to a very small subset of food packaging materials:
pesticide-treated food packaging that is distributed or sold with
the purpose of controlling pests. Food packaging that is not
distributed or sold to control pests is not a pesticide and is not
subject to this rule. For example, packaged products that are simply
treated with pesticides by food distributors, retailers or
homeowners solely to control pests on site do not themselves become
pesticides simply as a result of such applications. Rather, the
product itself must be distributed with the purpose of providing
pest control to become a pesticide. The treated packaging materials
addressed in this proposed rule are those that are sold for the
express purpose of providing ongoing protection from pests that may
contaminate the products made with the treated packaging.
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    Such inert ingredients are not used for a pesticidal purpose in the
production, storage, processing, or transportation of food. However, as
inert ingredients, these components of food packaging are also subject
to regulation as ``pesticide chemical residues'' under FFDCA section
408.
    Under section 408 of the FFDCA, any pesticide chemical residue in
or on food is deemed unsafe, unless EPA has established a tolerance or
tolerance exemption that covers the pesticide chemical residue. This is
true even though FDA may have previously issued regulations under
section 409 of FFDCA permitting the use of these materials in food
packaging that has not been treated with a pesticide. As a result, the
same food packaging materials would be subject to regulation under
FFDCA by both Agencies. EPA is today to giving FDA sole jurisdiction
under section 409 FFDCA over the packaging components (ingredients) of
food packaging materials that have been treated with a pesticide by
excepting these materials from the definition of ``pesticide chemical''
and ``pesticide chemical residue.'' Given FDA's expertise and
experience in regulating the components of food packaging, EPA and FDA
believe this rule will eliminate the duplicative FFDCA jurisdiction and
economize Federal government resources while continuing to protect
human health and the environment without additional regulatory
oversight by EPA.
    In 1998, EPA consciously limited the exception at 40 CFR 180.4 to
food packaging materials impregnated with an insect repellent, since at
the time of promulgation EPA had only received an application for a
pesticide product containing an insect repellent. EPA has now received
applications for other treated food packaging products that contain
active ingredients that are not insect repellents and will not be
applied through impregnation of the materials. EPA and FDA believe it
is appropriate to extend the 1998 rule to give FDA sole jurisdiction
under the FFDCA over the inert ingredients in such food packaging
products without regard to the application technique and mode of action
of the active ingredients in such products. Again, this rule will not
affect EPA's jurisdiction under section 408 over ingredients other than
the packaging materials in such products (including the pesticide
active ingredient), nor does it affect EPA's jurisdiction under FIFRA
to regulate such products.

B. What is the Agency's Authority for Taking this Action?

    Section 201(q)(3) of FFDCA, as amended by the Food Quality
Protection

Act (FQPA), allows the Administrator, under specified conditions, to
except certain substances from the definition of ``pesticide chemical''
or ``pesticide chemical residue'' if--
    (A) Its occurrence as a residue on or in a raw agricultural
commodity or processed food is attributable primarily to natural
causes or human activities not involving the use of any substance
for a pesticidal purpose in the production, storage, processing, or
transportation of any raw agricultural commodity or processed food;
and
    (B) The Administrator, after consultation with the Secretary,
determines that the substance more appropriately should be regulated
under one or more provisions of this Act other than sections
402(a)(2)(B) and 408.
    With today's action, EPA excepts from the definition of ``pesticide
chemical'' substances that are inert ingredients in food packaging
treated with a pesticide, when such ingredients are the components of
the food packaging (e.g. paper and paperboard, coatings, adhesives and
polymers).
    As previously explained, this final rule will not affect EPA's
regulation of such substances as inert ingredients under FIFRA. EPA
will continue to exercise jurisdiction under FIFRA over these
substances when they are used as inert ingredients in food packaging
that is intended to produce a pesticidal effect. The materials that
make up food packaging treated with a pesticide may serve one of two
purposes:
    1. To control pests, or
    2. To be one of the materials that make up the container for food.
As a result of this rule, EPA will continue to regulate the materials
that control pests and FDA will regulate the substances that make up
the food packaging material. Consistent with EPA's pesticide
registration regulations, EPA will not issue a registration under FIFRA
for pesticide products containing food packaging inert ingredients if
the presence of these ingredients in or on food is not authorized or
permitted by FFDCA and the implementing regulations.
    EPA, in consultation with FDA, believes that section 201(q)(3) is
applicable to inert ingredients in pesticide treated food packaging
materials that are the components of the food packaging (paperboard,
coatings, etc). When such inert ingredients are the components of the
food packaging itself, EPA believes the occurrence of these substances
as residues in or on food would be appropriately excepted from the
definition of ``pesticide chemical'' or ``pesticide chemical residue''
because such substances are not attributable primarily to the use of
the substances for a pesticidal purpose in the production, storage,
processing or transportation of food. Rather, the presence of such
substances as residues in food is primarily attributable to their use
for purposes of packaging food. For this reason, and because of FDA's
considerable experience in regulating such substances found in food
packaging, EPA and FDA believe it is appropriate for FDA to regulate
these inert ingredients under section 409 of FFDCA.
    As noted, this regulation will except from the definition of
``pesticide chemical'' and ``pesticide chemical residue'' any inert
ingredient that is a component of food packaging material treated with
a pesticide. EPA, in consultation with FDA, believes the identity of
the pesticide in or on the packaging material is not relevant to a
determination under section 201(q)(3) regarding whether it is
appropriate to except an inert ingredient from the definition of
pesticide chemical or pesticide chemical residue. As noted in this
unit, that determination turns only on whether:
    1. The occurrence of the residues of the substance in or on food is
attributable primarily to the use of substances for a pesticidal
purpose in the production, storage, processing or transportation of
food; and
    2. Whether it is more appropriate to regulate such substances under
another provision of FFDCA other than sections 402(a)(2)(B) and 408.
Thus, EPA has determined that inert ingredients that are the components
of the food packaging material in pesticide treated food packaging are
more appropriately regulated by FDA under FFDCA. This final rule will
therefore amend 40 CFR 180.4 to extend the exception contained therein
to any food packaging materials treated with a pesticide.

III. Response to Comments

    EPA received comments both on the rule when it was published as a
direct final rule on December 6, 2006 (71 FR 70667) (FRL-8084-2), and
again, following withdrawal of the direct final (February 2, 2007 (72
FR 4963) (FRL-8111-3), when the rule was published for comment as a
proposed rule on April 6, 2007 (72 FR 17068) (FRL-8119-8).
    The majority of the comments opposed finalizing today's rule.
However, most of these comments did not address the substance of the
rule itself - i.e., the transfer of authority under the FFDCA from EPA
to FDA only for the purposes of regulating the actual packaging
materials in food packaging products treated with pesticides. Rather,
these comments objected to the inclusion of pesticides in treated
packaging as a general matter - which is a matter beyond the scope of
this rule. As discussed in Unit II. in this preamble, this rule does
not alter the regulatory scheme under either FIFRA or the FFDCA for
pesticidally active substances in food packaging or the products they
are contained in. Any such products, including all the ingredients in
such products, must be evaluated under FIFRA on a case-by-case basis.
Additionally, subject to the limited exception for certain
antimicrobial pesticides provided in FFDCA section 201(q)(1)(B)(ii)(see
footnote 1 in Unit II.A.), the active ingredients in such products (as
well as those inert ingredients that are not part of the food packaging
itself) will continue to be subject to EPA regulation under section 408
of the FFDCA.
    EPA understands from the comments that there is some concern about
the risks that may exist from the inclusion of pesticides in treated
food packaging. As noted, EPA will continue to evaluate any
applications it receives for such products under the stringent health
and safety standards of both FIFRA and the FFDCA (except as provided by
section 201(q)(1)(B)(ii)). These laws require EPA to find that residues
of pesticides in food are safe and to determine whether pesticide
products cause unreasonable risk to human health or the environment.
Further, it should be noted that the applications for registration of
treated packaging materials EPA has received to date are for products
that may serve to limit the need for food storage establishments to use
riskier pesticides that are currently used to control pests in such
establishments. To be clear, however, the fact that these products may
serve to replace more risky pesticides does not alter EPA's obligation
to ensure that such products meet stringent food safety standards.
    EPA also received a comment that the rule would eliminate
protections for infants and children and affect EPA's jurisdiction to
regulate pesticidal substances for which no pesticidal claims are made.
EPA disagrees with this comment. EPA believes the commenter has
incorrectly interpreted the import of today's action. As noted in Unit
II., this action does not alter EPA's regulation of pesticidally active
ingredients under the FFDCA - or of those inert ingredients that do not
constitute food packaging materials. Further, under FIFRA, EPA must
still evaluate the entire pesticide product (including all active and
inert ingredients) before making a registration determination. And as
noted, before

EPA can register a pesticide product under FIFRA, it must determine
that the product will not present unreasonable risk to human health or
the environment. The only materials that are excepted from EPA
regulation under FFDCA section 408 by this rule are those materials
regulated by the FDA as food packaging -- that is, materials that are
now found in food packaging on store shelves irrespective of whether
those products are treated with a pesticide. These materials include
the paper, cardboard, adhesives and coatings that are found in
thousands of food packaging products across America today that are
currently subject to FDA regulation. Accordingly, this rule does not
eliminate protections for infants and children. Also, as explained in
Unit II., this rule will have no impact on the regulation of substances
under either the FFDCA or FIFRA that are not themselves food packaging
materials. Finally, this rule does not, as the commenter suggests,
alter EPA's jurisdiction over certain pesticidal substances for which
no pesticidal claims are made. Substances or mixtures of substances are
subject to regulation as pesticides under FIFRA if, among other things,
they are intended for ``preventing, destroying, repelling, or
mitigating any pest'' (FIFRA section 2(u)). EPA has developed
regulations at 40 CFR 152.15 to implement this standard. Nothing in
today's action alters EPA's interpretation in that regulation of the
section 2(u) ``intent'' test.
    EPA received two comments seeking clarification regarding certain
aspects of the rule. One commenter sought clarification that:
    1. The rule only excepts components of packaging that exhibit no
pesticidal properties;
    2. EPA will continue to regulate the active ingredients in such
products under the FFDCA; and
    3. The entire treated packaging product as sold or distributed will
be regulated under FIFRA.
 This is correct. As noted, this rule does not relieve EPA of its
obligation under the FFDCA to evaluate active ingredients in treated
packaging products - or for that matter, inert ingredients in such
products that are not part of the packaging materials of such products.
Further, the rule does not alter EPA's regulation of the entire product
under FIFRA. It simply eliminates duplicative federal regulation of the
actual packaging materials in treated packaging products; materials
already subject to FDA regulation under the FFDCA.
    Finally, to be clear, the rule only exempts such inert ingredients
when found in treated packaging products. To the extent that these same
materials can be expected to result in residues on food from use of
pesticide products that are not treated packaging products, a tolerance
or a tolerance exemption under section 408 of the FFDCA would still be
required.
    The second commenter, who apparently sells treated paper wrap
products, asked for clarification as to whether the rule alters EPA
regulation of the actual products they sell. As noted in Unit II.,
today's rule does not affect EPA's regulation of the actual treated
product under FIFRA.

IV. Statutory and Executive Order Reviews

    As an exception, this action does not impose any regulatory
obligations. Under Executive Order 12866 entitled Regulatory Planning
and Review (58 FR 51735, October 4, 1993), it has been determined that
this rule is not ``significant'' and is not subject to OMB review. This
rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et.
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4). ). This rule has no federalism or tribal
implications, because it will not have substantial direct effects on
States or Indian tribes, on the relationship between the Federal
Government and the States or Indian tribes, or on the distribution of
power and responsibilities among the various levels of government or
between the Federal Government and Indian tribes, as specified in
Executive Orders 13132 (entitled Federalism, 64 FR 43255, August 10,
1999) and 13175 (entitled Consultation and Coordination with Indian
Tribal Governments, 65 FR 67249, November 6, 2000). Nor does this rule
raise issues that require special considerations under Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994), or require OMB review in accordance with Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997). This rule is also not
subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution or
Use (66 FR 28355, May 22, 2001), because this action is not expected to
affect energy supply, distribution, or use. In addition, this action
does not involve any standards that would require Agency consideration
pursuant to section 12(d) of the National Technology Transfer and
Advancement Act (NTTAA) (Pub. L. 104-113).
    Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the
Agency hereby certifies that this regulatory action will not have a
significant economic impact on a substantial number of small entities,
because this regulatory action is an exemption and imposes no
regulatory obligations. EPA will provide this information to the Small
Business Administration's office of Advocacy upon request.

V. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: September 11, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.4 is amended by revising paragraph (a) to read as
follows:

Sec.  180.4 Exceptions.

* * * * *
    (a) Inert ingredients in food packaging treated with a pesticide,
when such inert ingredients are the components of the food packaging
material (e.g. paper

and paperboard, coatings, adhesives, and polymers).
* * * * *

[FR Doc. E8-21958 Filed 9-23-08; 8:45 am]

BILLING CODE 6560-50-S


Draft Version Sent to OMB, 4/10/07

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 94

[EPA-HQ-OAR-2007-0120; FRL_XXXX-X]

RIN 2060-A026

Change in Deadline for Rulemaking to Address the Control of Emissions
from New Marine Compression-Ignition Engines at or Above 30 Liters per
Cylinder

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Direct Final Rule.

SUMMARY:    SEQ CHAPTER \h \r 1  A January 2003 final rule established
the first US emission standards for new compression-ignition Category 3
marine engines, those with a displacement at or above 30 liters per
cylinder displacement.  It also established a deadline of April 27, 2007
for EPA to promulgate a new tier of emission standards for these engines
as determined appropriate under Clean Air Act (CAA) section 213(a).
This rulemaking schedule was intended to allow EPA time to consider the
state of technology that may permit deeper emission reductions and the
status of international action for more stringent standards.  Since
2003, we have continued to gain a greater understanding of the technical
issues described in the final rule and to assess the continuing efforts
of manufacturers to apply advanced emission control technologies to
these very large engines, through ongoing discussions with various
stakeholders.  In addition, we have continued to work with and through
the International Maritime Organization (IMO) toward more stringent
international emission standards that would apply to all new marine
diesel engines on ships engaged in international transportation.  IMO is
an important forum for EPA to gather new information and data regarding
emission control technologies, costs, and other information on Category
3 engines and vessels.  IMO is also important because the majority of
ships used in international commerce are flagged in other nations.  Due
to the length of time necessary to assess advanced emission control
technologies much of the information that we believe is necessary to
develop more stringent Category 3 marine diesel engines standards has
only become available recently and we expect more information to come to
light in the course of the current negotiations underway at the IMO.
Therefore, EPA is adopting a new deadline for the rulemaking that will
consider the next tier of Category 3 marine diesel engine standards.
Under this new schedule, EPA would adopt a final rule by December 17,
2009.

DATES:    SEQ CHAPTER \h \r 1 This rule is effective on [Insert date 60
days from date of publication in the Federal Register] without further
notice, unless EPA receives adverse comment by [Insert date 30 days from
date of publication in the Federal Register] or a request for a public
hearing by [Insert date 20 days after date of publication in the Federal
Register].  If a hearing is requested by this date, it will be held at a
time and place to be published in the Federal Register.  After the
hearing, the docket for this rulemaking will remain open for an
additional 30 days to receive comments.  If a hearing is held, EPA will
publish a document in the Federal Register extending the comment period
for 30 days after the hearing.  If EPA receives adverse comments or a
request for public hearing, it will publish a timely withdrawal of the
direct final rule in Federal Register and inform the public that the
rule will not take effect.

ADDRESSES:  Submit your comments, identified by Docket ID No.
EPA-HQ-OAR-2007-0120, by one of the following methods:

  HYPERLINK "http://www.regulations.gov"  www.regulations.gov : Follow
the on-line instructions for submitting comments

Email:       HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
Fax:<PHONE_NUMBER>

Mail: Environmental Protection Agency, Mail Code: 6102T, 1200
Pennsylvania Ave., NW, Washington, DC, 20460.  Please include two
copies.

Hand Delivery: EPA Docket Center (Air Docket), U.S. Environmental
Protection Agency, EPA West Building, 1301 Constitution Avenue, NW.,
Room: 3334 Mail Code: 6102T, Washington, DC.  Such deliveries are only
accepted during the Docket’s normal hours of operation, and special
arrangements should be made for deliveries of boxed information.

Instructions:  Direct your comments to Docket ID No.
EPA-HQ-OAR-2007-0120.  EPA's policy is that all comments received will
be included in the public docket without change and may be made
available online at   HYPERLINK "http://www.regulations.gov"
www.regulations.gov , including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to be
CBI or otherwise protected through www.regulations.gov or e-mail.  The
HYPERLINK "http://www.regulations.gov"  www.regulations.gov  website is
an “anonymous access” system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment.  If you send an e-mail comment directly to EPA without
going through www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet.  If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit.  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.  Electronic files should avoid the
use of special characters, any form of encryption, and be free of any
defects or viruses.  For additional information about EPA’s public
docket visit the EPA Docket Center homepage at
http://www.epa.gov/epahome/dockets.htm.

Docket: All documents in the docket are listed in the   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov  index.  Although
listed in the index, some information is not publicly available, e.g.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, will be publicly
available only in hard copy.  Publicly available docket materials are
available either electronically in   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov  or in hard copy at
the EPA Docket Center, EPA/DC, EPA West, Room 3334, 1301 Constitution
Avenue, NW., Washington, DC. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the Air Docket is<PHONE_NUMBER>.

Public Hearing:  To request a public hearing, contact Mike Samulski at
(734) 214-4532 or<EMAIL_ADDRESS> If a public hearing is
held, persons wishing to testify must submit copies of their testimony
to the docket and to Mike Samulski at the address below, no later than
10 days prior to the hearing.

FOR FURTHER INFORMATION CONTACT: Michael Samulski, Assessment and
Standards Division, Office of Transportation and Air Quality, 2000
Traverwood Drive, Ann Arbor, MI, 48105; telephone number:  (734)
214-4532;  fax number:<PHONE_NUMBER>; email address:     HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>.

  SEQ CHAPTER \h \r 1 SUPPLEMENTARY INFORMATION:

I.   Why is EPA Using a Direct Final Rule?

	EPA is publishing this as a direct final rule because we view this as a
relatively noncontroversial action.  Based on what we have learned in
our consultations over the past several years, we do not believe that
this extension will delay the achievement of further emission reductions
from Category 3 marine engines beyond what could potentially have been
achieved and creates the opportunity for the development and
implementation of a more effective program for the longer term.
However, in the “Proposed Rules” section of today’s Federal
Register, we are publishing a separate document that will serve as the
proposed rule to consider adoption of the provisions in this direct
final rule if adverse comments or a request for a public hearing are
received on this action. We will not institute a second comment period
on this action.  Any parties interested in commenting must do so at this
time.  For further information about commenting on this rule, see the
ADDRESSES section of this document.

If EPA receives adverse comment or a request for a public hearing, we
will publish a timely withdrawal in the Federal Register informing the
public that this direct final rule will not take effect.  We would
address all public comments in any subsequent final rule based on the
proposed rule.

II.   Does This Action Apply to Me?

	This action will affect companies that manufacture, sell, or import
into the United States new marine compression-ignition engines for use
on vessels flagged or registered in the United States; companies and
persons that make vessels that will be flagged or registered in the
United States and that use such engines; and the owners or operators of
such U.S. vessels.  This action may also affect companies and persons
that rebuild or maintain these engines.  Affected categories and
entities include the following:

Category	NAICS Codea	Examples of potentially affected entities

Industry	333618	Manufacturers of new marine diesel engines.

Industry	336611	Manufacturers of marine vessels.

Industry	811310	Engine repair and maintenance.

Industry	483	Water transportation, freight and passenger.

a North American Industry Classification System (NAICS)

	This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action.  To determine whether particular activities may be affected by
this action, you should carefully examine the regulations.  You may
direct questions regarding the applicability of this action as noted in
FOR FURTHER INFORMATION CONTACT.

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

	A.  Submitting CBI.  Do not submit Confidential Business Information
(CBI) to EPA through www.regulations.gov or e-mail.  Clearly mark the
part or all of the information that you claim to be CBI.  For CBI
information in a disk or CD ROM that you mail to EPA, 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 claimed as CBI.  In
addition to one complete version of the comment that includes
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.  Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR Part 2.

	B.  Tips for Preparing Your Comments.  When submitting comments,
remember to:

Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date and page number).

Follow directions - The agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.

Explain why you agree or disagree; suggest alternatives and substitute
language for your requested changes.

Describe any assumptions and provide any technical information and/or
data that you used.

If you estimate potential costs or burdens, explain how you arrived at
your estimate in sufficient detail to allow for it to be reproduced.

Provide specific examples to illustrate your concerns, and suggest
alternatives.

Explain your views as clearly as possible, avoiding the use of profanity
or personal threats.

Make sure to submit your comments by the comment period deadline
identified.

IV. Summary of Rule

	In January 2003, we adopted standards for new Category 3
compression-ignition marine engines, at or above 30 liters per cylinder
displacement.  The program we adopted reflected a two-part approach.
EPA evaluated the emissions control potential from various kinds of
technology, alone or in combination, including (1) the in-cylinder
controls currently used on new marine engines to meet the international
consensus NOx standards contained in the International Convention for
the Prevention of Pollution from Ships (MARPOL Annex VI); (2) additional
use and optimization of these controls; and (3) more advanced
technologies such as SCR and water injection, EPA concluded that it
would not be appropriate to adopt long-term technology forcing standards
in that rulemaking.  Instead, we set a near-term standard effective in
2004 that is equivalent to the MARPOL Annex VI oxides of nitrogen (NOx)
standard and can be achieved through existing emissions control
technology.  We also committed to a subsequent rulemaking that would
review the Tier 1 near-term standards and if appropriate revise them
with a deadline to complete that rulemaking by April 27, 2007.  That
rulemaking schedule was intended to allow us additional time to consider
the state of technology that may permit deeper reductions and the status
of international action for more stringent standards.  We also stated we
would consider an additional tier of standards based on this assessment
of technological feasibility and other factors and consider the
application of these standards to foreign-flagged vessels that enter
U.S. ports.

	In assessing the potential of advance emission control technologies we
concluded that while further reductions could be achieved if a longer
lead time were allowed, a variety of technical reasons made it more
appropriate to defer final action on such longer-term standards to a
second rule-making.  An additional reason supporting this two-tier
approach was to facilitate international negotiations over the next
round of reductions that could be implemented under Annex VI, which in
turn could facilitate EPA’s regulatory program to reduce emissions
from Category 3 marine diesel engines.  IMO is an important forum for
EPA to gather new information and data regarding emission control
technology, costs, and other information.  The opportunity at IMO for
stringent international standards is also important because the vast
majority of vessels with Category 3 marine diesel engines that enter
U.S. waters are flagged outside the United States.  We are engaged in
the IMO negotiations with the understanding that adopting appropriate
international standards would be the most efficient mechanism to control
emissions from U.S. and foreign flagged vessels.

	In the past few years, new information has become available regarding
the effectiveness of advance emission control technologies on Category 3
engines which will assist us in developing new standards.  In addition,
the IMO has only recently begun negotiations for a new tier of
international standards.  EPA is actively engaged in these negotiations
as a member of the United States delegation, and the United States
recently submitted a proposal to IMO that describes a framework for
emission limits that, if enacted, could achieve significant reductions
in NOx, particulate matter (PM), and oxides of sulfur (SOx) emissions
from marine vessels.  We expect this framework to form the basis of our
domestic rulemaking proposal.  We are developing an Advance Notice of
Proposed Rulemaking under section 213 of the Clean Air Act which
describes EPA’s current thinking with regard to potential new
requirements for Category 3 marine powered vessels and identifies and
discusses a number of important issues upon which we will seek comment.
 We expect to issue the Advanced Notice within the next few months.

	In recognition of the current situation, EPA is taking this action to
establish a new rulemaking deadline that will facilitate our ability to
achieve this objective as part of the international process and through
the adoption of the same requirements through an EPA rulemaking.
Today’s action will establish a new rulemaking deadline of December
17, 2009 for a final rule addressing additional emission standards for
Category 3 marine engines that we determine are appropriate under
section 213(a)(3).

	Concurrent with conducting a rulemaking under CAA section 213(a) for
Category 3 marine powered vessels, we will continue to promote more
stringent standards at IMO and encourage the IMO to adopt emission
controls for Category 3 marine powered vessels that seek to aggressively
reduce the impact of marine ships on air quality.

V.  Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

	This action is not a "significant regulatory action" under the terms of
Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and is
therefore not subject to review under the EO. This direct final rule
merely changes the regulatory schedule for a rulemaking to address
emissions from Category 3 marine engines.  There are no new costs
associated with this rule.

B. Paperwork Reduction Act

	This action does not impose any new information collection burden.
This direct final rule merely changes the regulatory schedule for a
rulemaking to address emissions from Category 3 marine engines.
However, the Office of Management and Budget (OMB) has previously
approved the information collection requirements contained in the
existing regulations [40 CFR 94]  under the provisions of the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control
number 2060-0287, EPA ICR number 1684.08.  A copy of the OMB approved
Information Collection Request (ICR) may be obtained from Susan Auby,
Collection Strategies Division; U.S. Environmental Protection Agency
(2822T); 1200 Pennsylvania Ave., NW, Washington, DC 20460 or by calling
(202) 566-1672.

	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 in 40 CFR are listed in 40 CFR
part 9.

C. Regulatory Flexibility Act

	The Regulatory Flexibility Act (RFA) generally requires an agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedure
Act or any other statute unless the agency certifies that the rule will
not have a significant economic impact on a substantial number of small
entities.  Small entities include small businesses, small organizations,
and small governmental jurisdictions.

	For purposes of assessing the impacts of this final rule on small
entities, a small entity is defined as: (1) A small business that meet
the definition for business based on SBA size standards at 13 CFR
121.201; (2) a small governmental jurisdiction that is a government of a
city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is any
not-for-profit enterprise which is independently owned and operated and
is not dominant in its field.

	After considering the economic impacts of today's final rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities.  In
determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the primary
purpose of the regulatory flexibility analyses is to identify and
address regulatory alternatives "which minimize any significant economic
impact of the rule on small entities." 5 USC 603 and 604. Thus, an
agency may certify that a rule will not have a significant economic
impact on a substantial number of small entities if the rule relieves
regulatory burden, or otherwise has a positive economic effect on all of
the small entities subject to the rule.

	This direct final rule merely changes the regulatory schedule for a
rulemaking to address emissions from Category 3 marine engines.  We have
therefore concluded that today's final rule will relieve regulatory
burden for all affected small.

D. Unfunded Mandates Reform Act

	Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law
104-4, establishes requirements for federal agencies to assess the
effects of their regulatory actions on state, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with “federal mandates” that
may result in expenditures to state, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and to adopt
the least costly, most cost-effective, or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective, or least burdensome alternative if the
Administrator publishes with the final rule an explanation of why such
an alternative was adopted.

	Before EPA establishes any regulatory requirements that may
significantly or uniquely affect small governments, including tribal
governments, it must have developed under section 203 of the UMRA a
small government agency plan. The plan must provide for notifying
potentially affected small governments, enabling officials of affected
small governments to have meaningful and timely input in the development
of EPA regulatory proposals with significant federal intergovernmental
mandates, and informing, educating, and advising small governments on
compliance with the regulatory requirements.

	This rule contains no federal mandates for state, local, tribal
governments, or the private sector as defined by the provisions of Title
II of the UMRA. The rule imposes no enforceable duties on any of these
governmental entities. This rule contains no regulatory requirements
that would significantly or uniquely affect small governments. EPA has
determined that this rule contains no federal mandates that may result
in expenditures of more than $100 million to the private sector in any
single year.  This direct final rule merely changes the regulatory
schedule for a rulemaking to address emissions from Category 3 marine
engines.  This rule is not subject to the requirements of sections 202
and 205 of UMRA.

E. Executive Order 13132: Federalism

	Executive Order 13132, entitled “Federalism” (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
“meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.”
“Policies that have federalism implications” are defined in the
Executive Order to include regulations that have “substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.”

	Under Section 6 of Executive Order 13132, EPA may not issue a
regulation that has federalism implications, that imposes substantial
direct compliance costs, and that is not required by statute, unless the
Federal government provides the funds necessary to pay the direct
compliance costs incurred by State and local governments, or EPA
consults with State and local officials early in the process of
developing the regulation. EPA also may not issue a regulation that has
federalism implications and that preempts State law, unless the Agency
consults with State and local officials early in the process of
developing the regulation.

	Section 4 of the Executive Order contains additional requirements for
rules that preempt State or local law, even if those rules do not have
federalism implications (i.e., the rules will not have substantial
direct effects on the States, on the relationship between the national
government and the states, or on the distribution of power and
responsibilities among the various levels of government). Those
requirements include providing all affected State and local officials
notice and an opportunity for appropriate participation in the
development of the regulation. If the preemption is not based on express
or implied statutory authority, EPA also must consult, to the extent
practicable, with appropriate State and local officials regarding the
conflict between State law and Federally protected interests within the
agency's area of regulatory responsibility.

	This rule does not have federalism implications. It will not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132.  This direct final rule merely
changes the regulatory schedule for a rulemaking to address emissions
from Category 3 marine engines.  Thus, Executive Order 1312 does not
apply to this rule.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

	Executive Order 13175, entitled “Consultation and Coordination with
Indian Tribal Governments” (59 FR 22951, November 6, 2000), requires
EPA to develop an accountable process to ensure “meaningful and timely
input by tribal officials in the development of regulatory policies that
have tribal implications.” “Policies that have tribal
implications” is defined in the Executive Order to include regulations
that have “substantial direct effects on one or more Indian tribes, on
the relationship between the Federal government and the Indian tribes,
or on the distribution of power and responsibilities between the Federal
government and Indian tribes.”

	This rule does not have tribal implications. It will not have
substantial direct effects on tribal governments, on the relationship
between the Federal government and Indian tribes, or on the distribution
of power and responsibilities between the Federal government and Indian
tribes, as specified in Executive Order 13175. This rule does not
uniquely affect the communities of Indian Tribal Governments. Further,
no circumstances specific to such communities exist that would cause an
impact on these communities beyond those discussed in the other sections
of this rule. This direct final rule merely changes the regulatory
schedule for a rulemaking to address emissions from Category 3 marine
engines.  Thus, Executive Order 13175 does not apply to this rule.

G. Executive Order 13045: Protection of Children from Environmental
Health and Safety Risks

	Executive Order 13045, “Protection of Children from Environmental
Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies
to any rule that (1) is determined to be “economically significant”
as defined under Executive Order 12866, and (2) concerns an
environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, Section 5-501 of the Order directs the Agency to
evaluate the environmental health or safety effects of the planned rule
on children, and explain why the planned regulation is preferable to
other potentially effective and reasonably feasible alternatives
considered by the Agency.

	This rule is not subject to the Executive Order because it is not
economically significant as defined in EO 12866, and because the Agency
does not have reason to believe the environmental health or safety risks
addressed by this action present a disproportionate risk to children.
This direct final rule merely changes the regulatory schedule for a
rulemaking to address emissions from Category 3 marine engines.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

	This rule is not a “significant energy action” as defined in
Executive Order 13211, “Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use” (66 FR
28355, May 22, 2001) because it is not likely to have a significant
adverse effect on the supply, distribution or use of energy.  This
direct final rule merely changes the regulatory schedule for a
rulemaking to address emissions from Category 3 marine engines.

I. National Technology Transfer and Advancement Act

	Section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (“NTTAA”), Public Law 104-113, section 12(d) (15 U.S.C. 272
note) directs EPA to use voluntary consensus standards in its regulatory
activities unless doing so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (such as materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.

	This direct final rule does not involve technical standards.  This
direct final rule merely changes the regulatory schedule for a
rulemaking to address emissions from Category 3 marine engines.
Therefore, EPA did not consider the use of any voluntary consensus
standards.

J.  Executive Order 12898:  Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations

	Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice.  Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission by
identifying and addressing, as appropriate, disproportionately high and
adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.

	EPA has determined that this rule will not have disproportionately high
and adverse human health or environmental effects on minority or
low-income populations because it does not affect the level of
protection provided to human health or the environment.  This direct
final rule merely changes the regulatory schedule for a rulemaking to
address emissions from Category 3 marine engines.

K.	Congressional Review Act

	The Congressional Review Act, 5 U.S.C. 801 et seq., as amended by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating the
rule must submit a rule report, which includes a copy of the rule, to
Congress and the Comptroller General of the United States. We will
submit a report containing this rule and other required information to
the U.S. Senate, the U.S. House of Representatives, and the Comptroller
General of the United States before publication of the rule in the
Federal Register. A major rule cannot take effect until 60 days after it
is published in the Federal Register.  This action is not a “major
rule” as defined by 5 U.S.C. 804(2). This direct final rule is
effective on [insert 60 days after Federal Register publication].

L. 	Statutory Authority

	The statutory authority for this action comes from section 213 of the
Clean Air Act as amended (42 U.S.C. 7547).  This action is a rulemaking
subject to the provisions of Clean Air Act section 307(d).  See 42
U.S.C. 7607(d).

List of Subjects in 40 CFR Part 94

Environmental protection, Administrative practice and procedure, Air
pollution control, Confidential business information, Imports,
Penalties, Reporting and recordkeeping requirements, Vessels,
Warranties.

Dated:

___________________________________________________

Stephen L. Johnson,

Administrator.

	For the reasons set out in the preamble, title 40, chapter I of the
Code of Federal Regulations is amended as follows:

PART 94—CONTROL OF AIR POLLUTION FROM MARINE COMPRESSION –IGNITION
EMISSIONS

1.  The authority citation for part 94 continues to read as follows:

Authority: 42 U.S.C. 7401-7671q.

2.	Section 94.8 is amended by revising paragraph (a)(2)(ii) to read as
follows:

§94.8  Exhaust emission standards.

(a)  *	*	*

(2)  *	*	*

(ii)  EPA has not finalized Tier 2 standards for Category 3 engines.
EPA will promulgate final Tier 2 standards for Category 3 engines on or
before December 17, 2009.

*	*	*	*	*

 “Control of Emissions from New Marine Compression-Ignition Engines at
or Above 30 Liters Per Cylinder; Final Rule,” 68 FR 9746, February 28,
2003.

 “Revision of MARPOL Annex VI, The NOx Technical Code and Related
Guidelines; Development of Standards for NOx, PM, and SOx,” Submitted
by the United States to the Sub-Committee on Bulk Liquids and Gases,
11th Session, 2007.

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