[Federal Register Volume 77, Number 112 (Monday, June 11, 2012)]
[Notices]
[Pages 34388-34389]
[FR Doc No: 2012-14003]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-E-0133; FDA-2011-E-0136]

Determination of Regulatory Review Period for Purposes of Patent
Extension; CYSVIEW (Previously HEXVIX)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for CYSVIEW (previously HEXVIX) and is
publishing this notice of that determination as required by law. FDA
has made the determination because of the submission of applications to
the Director of Patents and Trademarks, Department of Commerce, for the
extension of a patent which claims that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6284, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of the application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product CYSVIEW
(hexaminolevulinate hydrochloride). CYSVIEW is an optical imaging agent
indicated for use in the cystoscopic detection of non-muscle invasive
papillary cancer of the bladder among patients suspected or known to
have lesion(s) on the basis of a prior cystoscopy. Subsequent to this
approval, the Patent and Trademark Office received patent term
restoration applications for CYSVIEW (U.S. Patent Nos. 7,247,655 and
7,348,361) from Photocure ASA, and the Patent and Trademark Office
requested FDA's assistance in determining the patents' eligibilities
for patent term restoration. In a letter dated June 9, 2011, FDA
advised the Patent and Trademark Office that this human drug product
had undergone a regulatory review period and that the approval of
CYSVIEW represented the first permitted commercial marketing or use of
the product. Thereafter, the Patent and Trademark Office requested that
FDA determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
CYSVIEW is 3,103 days. Of this time, 2,770 days occurred during the
testing phase of the regulatory review period, while 333 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: November 30, 2001. The applicant claims October 29, 2001, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was November 30, 2001, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: June 30,
2009. FDA has verified the applicant's claim that the new drug
application (NDA) for CYSVIEW (NDA 22-555) was submitted on June 30,
2009.
    3. The date the application was approved: May 28, 2010. FDA has
verified the applicant's claim that NDA 22-555 was approved on May 28,
2010.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
applications for patent extension, this applicant seeks 686 days or 564
days, respectively, of patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by August 10, 2012. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review

period by December 10, 2012. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document.
    Comments and petitions that have not been made publicly available
on http://www.regulations.gov may be viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 29, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-14003 Filed 6-8-12; 8:45 am]
BILLING CODE 4160-01-P


Mary Kissell To: etoy@ omb. eop. gov 01/ 26/ 2004 04: 52 PM cc: Ken Hustvedt/ RTP/ USEPA/ US@ EPA, pkhanks@ rti. org, JohnB Chamberlin/ DC/ USEPA/ US@ EPA, Scott Jenkins/ RTP/ USEPA/ US@ EPA Subject: PCWP Materials Edmond,

EPA RTP was closed today. Due to the weather, it is unlikely I will be able to get to work tomorrow either. Will forward risk assessment document to you when I get back to the office or, if possible, have someone else forward it to you. Let's hope to be back to work soon! Mary Tom


[Federal Register Volume 79, Number 135 (Tuesday, July 15, 2014)]
[Notices]
[Pages 41333-41335]
[FR Doc No: 2014-16500]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72574; File No. SR-NYSEMKT-2014-55]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Amending the NYSE Amex
Options Fee Schedule in a Number of Different Ways

July 9, 2014.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on July 1, 2014, NYSE MKT LLC (the ``Exchange'' or ``NYSE
MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. 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\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend the NYSE Amex Options Fee Schedule
(``Fee Schedule'') in a number of different ways. The proposed changes
will be operative on July 1, 2014. The text of the proposed rule change
is available on the Exchange's Web site at www.nyse.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 self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to amend the Fee Schedule in a number of
different ways as described below. The proposed changes will be
operative on July 1, 2014.
    First, the Exchange proposes to adopt separate fees for electronic
transactions in securities that are not included as part of the Penny
Pilot Program (``Non Penny Pilot'') for Broker Dealers, Professional
Customers, Non NYSE Amex Options Market Makers and Firms, similar to
how NYSE Amex Options Markets Makers liable for Marketing Charges pay a
different rate for electronic executions in Penny versus Non Penny
Pilot names.\4\ Specifically, the Exchange is proposing a fee of $0.58
per contract for Broker Dealers, Professional Customers, Non NYSE Amex
Options Market Maker and Firms who electronically transact in Non Penny
Pilot issues. The rate per contract for those same participants who
electronically transact in Penny Pilot issues will be the same rate
they are presently charged for electronic transactions generally. For
example, Broker Dealers, Professional Customers and Firms presently pay
$0.32 per contract for electronic transactions and Non NYSE Amex
Options Market Makers pay $0.43 per contract for electronic
transactions--these will continue to be the rates charged to those
participants for electronic transactions in Penny Pilot issues.
---------------------------------------------------------------------------

    \4\ The Exchange charges $0.25 per contract for manual
transactions in both Penny and Non Penny issues and this rate will
remain unchanged.
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    The Exchange is also proposing a non-substantive, formatting change
to the section of the fee schedule that applies to Transaction Fees.
The Exchange is proposing to re-format that section of the fee schedule
as a table with distinct rows and columns (to distinguish charges for
manual versus electronic transactions) to make the fee schedule easier
for participants to understand.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6(b) \5\ of the Act, in general, and
Section 6(b)(4) and (5) \6\ of the Act, in particular, in that it is
designed to provide for the equitable allocation of reasonable dues,
fees, and other charges among its members and other persons using its
facilities and does not unfairly discriminate between customers,
issuers, brokers, or dealers.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange believes that the proposal to adopt separate fees for
electronic transactions in Non Penny Pilot securities for Broker
Dealers, Professional Customers, Non NYSE Amex Options Market Makers
and Firms is reasonable, equitable and not unfairly discriminatory for
the following reasons. First, the Exchange notes that the proposed per
contract fee of $0.58 is within the range of fees charged by other
exchanges for Broker Dealers, Professional Customers, Non NYSE Amex
Options Market Makers and Firms who electronically transact in Non
Penny Pilot issues.\7\ Further, the Exchange notes that the proposed
fee for these participants is still less than the fees for which a NYSE
Amex Options Market Maker might be liable. For example, an NYSE Amex
Options Market Maker that has reached the monthly fee cap
applicable,\8\ that electronically trades against a Customer in a Non
Penny issue will be liable for a maximum charge of $0.66 (comprised of
a $0.01 service fee and Marketing Charges of $0.65). For an NYSE Amex
Options Market Maker that has not reached the monthly fee cap and has
traded less than 50,000 contracts of ADV each day in the month, the
same transaction would result in a maximum fee of $0.85 per contract
(comprised of a transaction fee of $0.20 and Marketing Charges of
$0.65).
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    \7\ See NASDAQ OMX PHLX (``PHLX'') fee schedule, as of 6/19/2014
located here: http://www.nasdaqtrader.com/Micro.aspx?id=phlxpricing.
PHLX charges Professionals, Broker Dealers, and Firms $0.70 per
contract to transact electronically in Non Penny Pilot issues and
$0.48 per contract in Penny issues. See also the Nasdaq Options
Market (``NOM'') fee schedule located here: http://www.nasdaqtrader.com/Micro.aspx?id=OptionsPricing, which charges
$0.89 per contract in Non Penny issues and $0.49 per contract in
Penny issues for Professionals, Broker Dealers, Firms and Non NOM
Market Makers who take liquidity.
    \8\ See NYSE Amex Options fee schedule dated June 12, 2014
located here: https://www.theice.com/publicdocs/nyse/markets/amex-options/NYSE_Amex_Options_Fee_Schedule.pdf.
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    NYSE Amex Options Market Makers are subject to other fees that are
either higher or not charged at all to Broker Dealers, Professional
Customers, Non NYSE Amex Options Market Makers and Firms, such as ATP
Permit fees and Rights Fees.\9\ For example, in order to transact
electronically on the Exchange, a NYSE Amex Options Market Maker is
required to have at least one options trading permit (``ATP'') that
allows it to quote sixty issues, plus the bottom 45% of issues traded
on the Exchange by volume. The cost of one ATP is $8,000 per month. A
NYSE Amex Options Market Maker that wishes to transact electronically
in all issues on the Exchange is required to have five ATPs, at a
monthly cost of $26,000. By comparison, in order to transact
electronically on the Exchange, Broker Dealers, Professional Customers,
Non NYSE Amex Options Market Makers and Firms are only required to have
a single ATP, at a monthly cost of $1,000.\10\ The Exchange notes the
monthly cost differential of $7,000 to $25,000 in ATP fees paid by NYSE
Amex Options Market Makers, while Broker Dealers, Professional
Customers, Non NYSE Amex Options Market Makers and Firms incur no such
cost. Therefore, while the NYSE Amex Options Markets Makers may be
charged a lower per contract rate than the rate proposed for Broker
Dealers, Professional Customers, Non NYSE Amex Options Market Makers
and Firms transacting electronically in Non Penny issues, when all
costs to these participants are considered, the cost differential is
much less or even transposed, with NYSE Amex Options Market Makers
paying higher fees.\11\ As such, the Exchange believes that charging
Broker Dealers, Professional Customers, Non NYSE Amex Options Market
Makers and Firms a higher rate to transact electronically in Non Penny
issues is equitable and reasonable as the higher rate is designed to
reflect the costs to the Exchange in supporting trading in Non Penny
issues.\12\ While Non Penny issues account for the vast majority of
issues by count, Non Penny issues represent a relatively small
percentage of overall total industry volume. For example, there are
currently 358 issues in the Penny Pilot as compared with 2,054 Non
Penny issues listed on the Exchange. However, with respect to volume
during the past

two months ending in May 2014, Penny Pilot options accounted for 81% of
Total Industry Equity Option volume, while Non Penny issues accounted
for only 19% of Total Industry Equity Option Volume.
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    \9\ Id.
    \10\ Of the participants in question, only Firms are members of
the Exchange that are billed directly for any ATPs they own. All of
the other participants conduct business through an Exchange member
that is only required to have a single ATP for all business that
flows through them. For example, an Order Flow Provider with a
single ATP may route electronic orders to the Exchange on behalf of
Broker Dealers, Professional Customers and Non NYSE Amex Options
Market Makers.
    \11\ For example, an NYSE Amex Market Makers [sic] that
electronically trades contra to a Customer is potentially liable for
Marketing Charges. Further, the Exchange notes that a subset of NYSE
Amex Options Market Makers (Specialists, e-Specialists and Directed
Order Market Makers) also incur monthly Rights Fees, which fees are
not charged to Broker Dealers, Professional Customers, Non NYSE Amex
Options Market Makers and Firms. See supra n. 8.
    \12\ The Exchange notes that this higher rate is still below the
rate charged to an NYSE Amex Options Market Maker that
electronically trades with a Customer. See supra n. 8.
---------------------------------------------------------------------------

    For the forgoing reasons, the Exchange believes that the proposal
to charge $0.58 per contract to Broker Dealers, Professional Customers,
Non NYSE Amex Options Market Makers and Firms that transact
electronically in Non Penny Pilot issues is reasonable, equitable and
not unfairly discriminatory. The proposed fee is also reasonable,
equitable and not unfairly discriminatory because the charge will apply
equally to all Broker Dealers, Professional Customers, Non NYSE Amex
Options Market Makers and Firms electronically executed volumes in Non
Penny Pilot issues on the Exchange.
    The Exchange believes that the proposal to re-format the section of
the fee schedule describing Transaction Fees into a table and
delineating cost by transaction type (manual versus electronic) is
reasonable, equitable and not unfairly discriminatory as the proposed
change will reduce confusion and will make the fee schedule more
transparent and easier for all participants to understand.

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. The Exchange believes the
proposed fee change is reasonably designed to be fair and equitable,
and therefore, will not unduly burden any particular group of market
participants trading on the Exchange vis-[agrave]-vis another group
(i.e., Market Markers versus non-Market Makers). Specifically, the
Exchange believes that Broker Dealers, Professional Customers, Non NYSE
Amex Options Market Makers and Firms who are not subject to the
additional dues and fees of NYSE Amex Market Makers, will not be unduly
burdened by the increased transaction fee. In addition, the Exchange
believes that the proposed changes will enhance the competiveness of
the Exchange relative to other exchanges. The Exchange notes that it
operates in a highly competitive market in which market participants
can readily favor competing venues if they deem fee levels at a
particular venue to be excessive. In such an environment, the Exchange
must continually review, and consider adjusting, its fees and credits
to remain competitive with other exchanges. For the reasons described
above, the Exchange believes that the proposed rule change reflects
this competitive environment.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \13\ of the Act and subparagraph (f)(2) of Rule
19b-4 \14\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
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    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \15\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \15\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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-NYSEMKT-2014-55 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-NYSEMKT-2014-55. 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 Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 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-NYSEMKT-2014-55, and should
be submitted on or before August 5, 2014.
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    \16\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-16500 Filed 7-14-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: July 8, 2009 (Volume 74, Number 129)]
[Notices]
[Page 32664-32667]
[DOCID:fr08jy09-120]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60187; File No. SR-CBOE-2009-040]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing of a Proposed Rule Change Regarding a
New Options Market Linkage Structure

June 29, 2009.
    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 June 24, 2009, the Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I, II, and III 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.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The filing proposes to adopt certain new order handling rules in
connection with a new options industry linkage structure. The text of
the proposed rule change is available on the Exchange's Web site
(http://www.cboe.org/legal), at the Exchange's Principal office, 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 self-regulatory organization
included statements concerning the purpose of and basis for the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    This filing proposes to adopt rules to facilitate the Exchange's
transition to a new intermarket linkage structure. Since

2000, the Exchange has been a participant in the Plan for the Purpose
of Creating and Operating an Intermarket Option Linkage (the ``Old
Plan''). That plan achieved intermarket order protection via a spoke-
and-hub connectivity structure between options exchanges. The Options
Clearing Corporation acted as the hub and provided connectivity between
exchanges. This connectivity, which did not require the transmission of
orders to an exchange through a member of that exchange, allowed for
the sending of three order types: P/A orders (which are for the
principal account of a market-maker on behalf of a non-broker-dealer
customer), P Orders (orders for the proprietary account of a market-
maker), and Satisfaction Orders (orders reflecting the terms of a non-
broker-dealer customer order resting on an exchange that was traded-
through by another market).
    The Participants of the Old Plan have established a new plan to
provide a more modern framework for options market order protection and
locked/crossed markets. The new plan is called the Options Order
Protection and Locked/Crossed Market Plan (the ``Plan'' or ``New
Plan''). The New Plan does not route orders through a hub. Instead it
requires Participants to access better-priced quotations on another
market through a member of that market and via the transmission of a
new order-type: The Intermarket Sweep Order (``ISO''). The New Plan's
order protection provisions are modeled after Regulation NMS Rule 611.
    As described below, this filing adopts rules that correspond to the
order protection provisions of the New Plan (these rules will generally
be uniform with the rules of the other Participants). It also modifies
certain Exchange order handling rules to facilitate implementation of
the New Plan.

New Plan Rules

    The filing proposes to eliminate all of the language in the rules
relating to the Old Plan (Rules 6.80 through 6.85) and replace that
language with rules mirroring the terms of the New Plan. The new
Section E of Chapter 6 would contain a rule providing applicable
definitions (Rule 6.80), a rule governing order protection (Rule 6.81),
a rule governing locked and crossed markets (Rule 6.82), and a
temporary rule regarding the transition from the Old Plan framework to
the New Plan (Rule 6.83).
    Revised Rule 6.81 provides that members shall not effect trade-
throughs. It also lists the various exceptions to trade-through
liability. These are: (1) If an Eligible Exchange repeatedly fails to
respond within one second to incoming orders attempting to access its
Protected Quotations (provided certain notification, assessment, and
documentation requirements are met); (2) a transaction effected during
a trading rotation; (3) a transaction during a Crossed Market; (4) the
execution of an order identified as an ISO, or an execution effected on
the Exchange while it simultaneously routs an ISO to execute against
the full displayed size of any better-priced Protected Quotation; (5)
the Eligible Exchange displaying the Protected Quotation that was
traded through had displayed, within one second prior to execution of
the Trade-Through, a Best bid or Best offer, as applicable, for the
options series with a price that was equal or inferior to the price of
the Trade-Through transaction; (6) the Protected Quotation traded
through was being disseminated from an Eligible Exchange whose
Quotations were Non-Firm with respect to such options series; (7) the
execution of a Complex Trade; (8) the execution of an order for which,
at the time of receipt of the order, a Member had guaranteed an
execution at no worse than a specified price, where (i) the stopped
order was for the account of a Customer, (ii) the Customer agreed to
the specified price on an order-by-order basis, and (iii) the price of
the Trade-Through was, for a stopped buy (sell) order, lower (higher)
than the national Best Bid (Offer) in the options series at the time of
execution; (9) the execution of an order that was stopped at a price
that did not Trade-Through an Eligible Exchange at the time of the
stop; and (10) the execution of an order at a price that was not based,
directly or indirectly, on the quoted price of the options series at
the time of execution and for which the material terms were not
reasonably determinable at the time the commitment to execute the order
was made.
    Proposed Rule 6.82 provides that members shall reasonably avoid
(and shall not engage in a pattern of) locking and crossing Protected
Quotations. The Rule contains the following exceptions: (1) The locking
or crossing quotation was displayed at a time when the Exchange was
experiencing a failure, material delay, or malfunction of its systems
or equipment; (2) The locking or crossing quotation was displayed at a
time when there is a Crossed Market; (3) The Member simultaneously
routed an ISO to execute against the full displayed size of any locked
or crossed Protected Bid or Protected Offer; and (4) The locking
quotation is permissible pursuant to Rules 6.45A(d) and 6.45B(d).\3\
---------------------------------------------------------------------------

    \3\ CBOE Rules 6.45A(d) and 6.45B(d) allow the Exchange to
temporarily disseminate a lock between Exchange Market-Makers. This
lock is firm for all buy and sell orders.
---------------------------------------------------------------------------

    Temporary Rule 6.83 provides that during the transition to the New
Plan, the Exchange will continue to receive and execute (and may send)
P/A and P orders if the Exchange is the NBBO. Once all Participants
have completely migrated to the New Plan structure, this Rule would
cease to be necessary. In connection with the transition, CBOE intends
to access other Participants via the use of P/A and P orders on a
temporary basis pursuant to exemptive relief we are requesting from the
Commission until the Exchange's roll-out of the new functionality is
complete (once ISO outbound routing is available for a class, the
Exchange will cease using P and P/A orders as well as ``old'' HAL
functionality for that class). The Exchange anticipates that the
migration to the New Plan functionality will take several weeks. The
Exchange will keep members informed of the rollout schedule via
circular and will identify on a class-by-class basis which classes are
trading pursuant to the temporary rule and utilizing ``old'' HAL as
well as which classes are trading pursuant to the ``new'' linkage rules
and HAL2.

HAL2

    The Exchange proposes to adopt a new Hybrid Agency Liaison System
(``HAL2'') in proposed Rule 6.14A. The Exchange will determine the
eligible order size, eligible order type, eligible order origin code
(i.e., public customer orders, non-Market Maker broker-dealer orders,
and Market Maker broker-dealer orders), and classes for HAL2.\4\ When
the Exchange receives a qualifying order that is marketable against the
NBBO and/or the Exchange's BBO,\5\ HAL2 will ``flash'' the order at the
NBBO price to allow CBOE Market-Makers appointed in that class as well
as all members acting as agent for orders at the top of the Exchange's
book in the relevant series (and other members if allowed by the
Exchange) to step-up to the NBBO price. The duration of the flash
period shall not exceed 1 second. The first responder to indicate an
interest to trade at the NBBO price will trade against the flashed
order up to the size of the response (the flash period will continue

for any unexecuted balance). Responders will also be allowed to respond
at prices worse than the NBBO but equal to or better than the
Exchange's BBO. At the end of the response period (if no responders
have matched the NBBO price or if there is a remainder on the flashed
order) the HAL2 system will ascertain the best available price(s)
between all pending responses and the best disseminated prices on other
exchanges, and then execute the flashed order at the best price(s) by
trading it against flash responses first and transmitting ISOs to other
exchanges second.
---------------------------------------------------------------------------

    \4\ As classes migrate to the New Plan on CBOE, the Exchange
will be able to utilize HAL2 for those classes (i.e. HAL2 will only
be available for classes trading pursuant to the New Plan).
    \5\ Unless the Exchange's quotation contains resting orders and
does not contain sufficient Market-Maker quotation interest to
satisfy the entire order.
---------------------------------------------------------------------------

    For example, CBOE's best offer is 1.22 for 200 contracts, and the
NBBO is 1.19 for 10 contracts with one other market disseminating a
1.20 offer for 20 contracts. An order to buy 100 contracts at 1.22 is
received. The order will be flashed at 1.19. Market-Maker A immediately
submits a response to trade 10 contracts at 1.19. As a result 10
contracts trade against Market-Maker A at 1.19 (leaving 90 contracts on
the order). During the remaining flash period Market-Maker B submits a
response to trade 20 contracts at 1.21. As soon as the flash period
concludes (assuming the away market prices have not changed), the
system will simultaneously: Route an ISO to buy 10 contracts at 1.19 to
the NBBO market, route an ISO to buy 20 contracts at 1.20 to the market
displaying the 1.20 offer, execute 20 at 1.21 against Market-Maker B,
and execute the remaining 40 against the Exchange's 1.22 offer using
the matching algorithm in effect for the class.
    If any portion of an order that is routed away returns unfilled,
the Exchange will deem it a ``new'' order for processing purposes and
trade it against the best bid/offer on the Exchange unless another
exchange is quoting a better price in which case the Exchange will
attempt to access such better price with a new ISO order. Any
executions at the Exchange's best bid/offer will be handled in two
batches: First against all interest resting at that price at the time
the flashed order was received, and second against any interest that
joined at that price after the flash process commenced (in both cases
the matching algorithm in effect for that class will be used). The
Exchange also notes that order senders can bypass HAL2 processing by
submitting Immediate or Cancel Orders.
    Paragraph (d) of proposed Rule 6.14A lists the circumstances in
which a flash period would terminate early. Those are: (1) If the
Exchange receives an unrelated order on the same side of the market as
the flashed order that is priced equal to or better than the flashed
order; (2) if, in the case of an exposed order that is marketable
against the Exchange's BBO, Market-Maker interest at the BBO decrements
to a size that would be equal to or smaller than the size of the
exposed order; and (3) if an unrelated order or quote on the opposite
side of the market from the exposed order is received that could trade
against the exposed order at the prevailing NBBO or better in which
case the orders would trade at the NBBO unless the unrelated order is a
customer order in which case the orders would trade at the midpoint of
the unrelated order's limit price and the NBBO (e.g. the NBBO/flash
price for a buy order is 1.15, during the exposure period a customer
limit order to sell at 1.13 is received, the orders will be matched to
the greatest extent possible at 1.14 providing price improvement to
both orders).\6\
---------------------------------------------------------------------------

    \6\ If the unrelated order was smaller than the exposed order,
then the flash would continue for the unexecuted balance of the
exposed order.
---------------------------------------------------------------------------

    Lastly, Interpretation and Policy .01 to Rule 6.14A provides that
the Exchange will limit redistribution of exposed order messages to
third parties. Essentially, the purpose of this provision is to provide
the Exchange with flexibility to restrict members from passing on or
redistributing flash messages to others. Of course, the provisions of
Exchange Rule 4.1 (Just and Equitable Principles of Trade) and 4.18
(Prevention of the Misuse of Material, Nonpublic Information) apply to
all HAL2 trading.

Price Check Parameter

    A new price check parameter is also being adopted in connection
with the new HAL2 process (this new parameter is in Rule 6.13(vi)). For
classes in which HAL2 is activated, the Exchange will not automatically
execute orders that are marketable if the NBBO width is not within an
acceptable price range established by the Exchange (APR), or if an
execution would follow an initial partial execution and occur at a
price that is not within an acceptable tick distance from the initial
execution as established by the Exchange (ATD). If an execution is
suspended because of the APR, the order will route to PAR for handling.
If an execution is suspended because of the ATD, the order will be
exposed pursuant to the HAL2 process using the ATD as the exposure
price. If a quantity remains after the HAL2 process, the balance will
route to PAR (in this regard, the HAL2 processing for these orders is
different that normal HAL2 processing). The Exchange notes that users
may bypass this processing by submitting orders with an immediate or
cancel designation.

New Order Routing Rule

    The Exchange proposes to adopt new Rule 6.14B which would govern
the Exchange's process for routing sweep orders to other markets. The
Exchange intends to contract with one or more routing brokers that are
not affiliated with the Exchange to route sweep orders to other
exchanges. Any such contract will restrict the use of any confidential
and proprietary information that the routing broker receives to
legitimate business purposes necessary for routing orders at the
direction of the Exchange. Routing services would be available to
members only and are optional. Members that do not want orders routed
can use the Immediate or Cancel designation to avoid routing.
    The rule also provides that (1) the Exchange shall establish and
maintain procedures and internal controls reasonably designed to
adequately restrict the flow of confidential and proprietary
information between the Exchange and the routing broker, and any other
entity, including any affiliate of the routing broker, and, if the
routing broker or any of its affiliates engages in any other business
activities other than providing routing services to the Exchange,
between the segment of the routing broker or affiliate that provides
the other business activities and the segment of the routing broker
that provides the routing services; (2) the Exchange may not use a
routing broker for which the Exchange or any affiliate of the Exchange
is the designated examining authority; (3) the Exchange will provide
its Routing Services in compliance with the provisions of the Act and
the rules thereunder, including, but not limited to, the requirements
in Section 6(b)(4) and (5) of the Act that the rules of a national
securities exchange provide for the equitable allocation of reasonable
dues, fees, and other charges among its members and issuers and other
persons using its facilities, and not be designed to permit unfair
discrimination between customers, issuers, brokers, or dealers; (4) the
Exchange will determine the logic that provides when, how, and where
orders are routed away to other exchanges; (5) the routing broker
cannot change the terms of an order or the routing instructions, nor
does the routing broker have any discretion about where to route an
order; and, (6) any bid or offer entered on the Exchange routed to
another exchange via a routing broker that results in an execution
shall be

binding on the member that entered such bid/offer.

New Order Types

    The filing proposes to adopt several new order types that would be
added to Rule 6.53: (1) AIM Sweep Order. An AIM sweep order (AIM ISO)
is the transmission of two orders for crossing pursuant to Rule 6.74A
without regard for better priced Protected Bids/Offers because the
member transmitting the AIM ISO to the Exchange has, simultaneously
with the routing of the AIM ISO, routed one or more ISOs, as necessary,
to execute against the full displayed size of any Protected Bid/Offer
that is superior to the starting AIM auction price and has swept all
interest in the Exchange's book priced better than the proposed auction
starting price (with any execution(s) resulting from such sweeps shall
accrue to the AIM Agency Order); (2) Sweep and AIM Order. A sweep and
AIM order is the transmission of two orders for crossing pursuant to
Rule 6.74A with an auction starting price that does not need to be
within the Exchange's best bid and offer and where the Exchange will
``sweep'' all Protected Bids/Offers by routing one or more ISOs, as
necessary, to execute against the full displayed size of any Protected
Bid/Offer that is superior to the starting AIM auction price, as well
as sweep all interest in the Exchange's book priced better than the
proposed auction starting price concurrent with the commencement of the
AIM auction with any execution(s) resulting from such sweeps accruing
to the AIM Agency Order; and, (3) CBOE-Only Order. A CBOE-only order is
an order to buy or sell that is to be executed in whole or in part on
the Exchange without routing the order to another market center and
that is to be cancelled if routing would be required under the
Exchange's Rules.

Other Changes

    In connection with the new linkage structure and the adoption of
the rules described above, the Exchange is also making minor changes to
other Exchange rules including adding reference to HAL2 to Rule 6.2B,
eliminating The ``Removal of Unreliable Quotes'' provision of Rule
6.13, eliminating references in the Exchanges crossing mechanisms
(6.74A and 6.74B) to the block trade exemption of the Old Plan, and
deletion of Rule 8.52 relating to the now defunct Pilot Program for
Away Market Maker Access.

Implementation

    The Exchange represents that the proposed rules will not become
operative until the Exchange has withdrawn from the Old Plan.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) of the Act\7\ in general and furthers the objectives of
Section 6(b)(5) of the Act\8\ in particular in that, by making the
linkage process more efficient and offering users greater control over
order routing, it is designed to promote just and equitable principles
of trade, serve to remove impediments to and perfect the mechanism of a
free and open market and a national market system. Moreover, the
Exchange believes that adopting rules that implement the Plan will
facilitate the trading of options in a national market system by
establishing more efficient protection against trade-throughs.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    CBOE 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.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date 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 such 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2009-040 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2009-040. 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 the filing will also be available for
inspection and copying at the principal office of the self-regulatory
organization. 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-
CBOE-2009-040 and should be submitted on or before July 29, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-15992 Filed 7-7-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: August 5, 2009 (Volume 74, Number 149)]
[Rules and Regulations]
[Page 38956-38962]
[DOCID:fr05au09-20]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0042; FRL-8424-4]

Methyl Poly(Oxyethylene)C8-C18
Alkylammonium Chlorides; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of methyl poly(oxyethylene)C8-
C18 alkylammonium chlorides where the poly(oxyethylene)
content is n=2-15 and where C8-C18 alkyl is
linear and may be saturated or unsaturated, herein referred to in this
document as methyl poly(oxyethylene)C8-C18
alkylammonium chlorides (MPOACs), when used as an inert ingredient in
pesticide formulations for pre-harvest uses under 40 CFR 180.920 at a
maximum of 10% by weight in herbicide formulations and 5% by weight in
all other formulations. The Joint Inerts Task Force (JITF), Cluster
Support Team (CST No. 7), submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of MPOACs.

DATES: This regulation is effective August 5, 2009. Objections and
requests for hearings must be received on or before October 5, 2009,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0042. 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 (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide 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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Hamonized
Guidlines referenced in this document, go directly to the guidelines at
http://www.epa.gpo/opptsfrs/home/suidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0042 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before October 5, 2009.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0042, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Background

    In the Federal Register of March 4, 2009 (74 FR 9397) (FRL-8401-8),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 9E7518)
by The JITF, CST No. 7, c/o CropLife America, 1156 15th St.,
NW., Suite 400, Washington, DC 20005. The petition requested that 40
CFR 180.920 be

amended by establishing exemptions from the requirement of a tolerance
for residues of the inert ingredient methyl
poly(oxyethylene)C8-C18 alkylammonium chlorides
where the poly(oxyethylene) content is n=2-15 and where C8-
C18 alkyl is linear and may be saturated or unsaturated
(MPOACs) for pre-harvest uses at a maximum of 10% by weight in
herbicide formulations and 5% by weight in all other formulations. That
notice referenced a summary of the petition prepared by The JITF, CST
No. 7, the petitioner, which is available to the public in the docket,
http://www.regulations.gov.
    The Agency received two comments in response to the notice of
filing. Both comments was received from private citizens who opposed
the authorization to sell any pesticide that leaves a residue on food.
The Agency understands the commenters' concerns and recognizes that
some individuals believe that no residue of pesticides should be
allowed. However, under the existing legal framework provided by
section 408 of FFDCA, EPA is authorized to establish pesticide
tolerances or exemptions where persons seeking such tolerances or
exemptions have demonstrated that the pesticide meets the safety
standard imposed by that statute.
    This petition was submitted in response to a final rule of August
9, 2006, (71 FR 45415) (FRL-8084-1) in which the Agency revoked, under
section 408(e)(1) of the FFDCA, the existing exemptions from the
requirement of a tolerance for residues of certain inert ingredients
because of insufficient data to make the determination of safety
required by section 408(b)(2) of FFDCA. The expiration date for the
tolerance exemptions subject to revocation was August 9, 2008, which
was later extended August 9, 2009 by a final rule published in the
Federal Register of August 4, 2008. (73 FR 45312) (FRL-8372-7) to allow
for data to be submitted to support the establishment of tolerance
exemptions for these inert ingredients prior to the effective date of
the tolerance exemption revocation.

 III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
exemption from the requirement of a tolerance for residues of MPOACs
when used as inert ingredients in pesticide formulations for pre-
harvest uses at a maximum of 10% by weight in herbicide formulations
and 5% by weight in all other formulations. EPA's assessment of
exposures and risks associated with establishing tolerances follows.

 A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
     The toxicity data available on the MPOACs consists of acute
toxicity studies, mutagenicity studies, and an OPPTS Harmonized
Guideline 870.3650 combined repeated dose toxicity study with the
reproduction/developmental toxicity screening test. The majority of the
MPOAC compounds are reported as ``not acutely toxic'' for lethality by
the oral and dermal routes of exposure (Toxicity Category III).
However, CAS Reg. No. 70750-47-9, the representative test compound, is
more toxic by the oral and dermal routes (Toxicity Category II). All
MPOACs are severely irritating to the eye (Toxicity Category I), and
the MPOAC identified by CAS Reg. No.70750-47-9 (quatenary ammonium
compounds, coco alkylbis(hydroxyethyl)methy1, chlorides) is severely
irritating to the skin. Inhalation data on two of the MPOACs indicate
irritation at high doses.
    The OPPTS Harmonized Guideline 870.3650 study on the representative
surfactant, (CAS Reg. No. 70750-47-9) demonstrated severe toxicity in
rats, as evidenced by deaths of all test subjects at 100 milligrams/
kilogram/day (mg/kg/day) after 5 days, and deaths of 5 out of 10
females at 50 mg/kg/day after 6-8 days of exposure. Given the extremely
corrosive nature of the test material, the Agency believes that the
high mortality rate is secondary to the forestomach lesions seen in the
rats. Further, the Agency notes that the severity of the effects may be
related to the unique anatomy of the rats. Humans do not have a
forestomach which serves as a storage reservoir in rodents; therefore,
effects seen in the rat forestomach are likely to be significantly more
severe than what would be expected from the compound in the glandular
stomachs in humans and therefore, have less relevance to humans.
    The no observed adverse effect level (NOAEL) for developmental and
reproductive toxicity is 25 mg/kg/day, the lowest dose tested (LDT).
Although no reproductive or developmental effects were observed at the
next higher dose of 50 mg/kg/day, the evaluation at

this dose level included only 5 surviving female animals. While the
actual lowest observed adverse effect level (LOAEL) for reproductive
developmental effects may be higher, or reproductive developmental
effects may not occur at all as a result of exposure to this chemical,
in the absence of a sufficient number of animals to assess, the Agency
has conservatively assumed that if more animals had been available at
the mid-dose, developmental or reproductive toxicity might have been
observed. There are no concerns for sensitivity of offspring.
    There was no evidence of neurotoxicity in this study; functional-
observational battery and motor-activity data were similar in all the
treatment groups. Liver enzymes were elevated but were not accompanied
by microscopic lesions or increased organ weight and were not
considered adverse. No carcinogenicity studies are available for the
MPOACs. A qualitative structure activity relationship database, DEREK
Version 11, identified no structural alerts suggestive of
carcinogenicity.
    Specific information on the studies received and the nature of the
adverse effects caused by MPOACs as well as the NOAEL and the LOAEL
from the toxicity studies can be found at http://www.regulations.gov in
document MPOACs-JITF CST No. 7 Inert Ingredients). Human Health Risk
Assessment to Support Proposed Exemption from the Requirement of a
Tolerance When Used as Inert Ingredients in Pesticide Formulations
pages 9-13 and pages 25-26 in docket ID number EPA-HQ-OPP-2009-0042.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose tested (HDT) at
which the NOAEL in the toxicology study identified as appropriate for
use in risk assessment. However, if a NOAEL cannot be determined, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) or a benchmark dose (BMD) approach is sometimes used for risk
assessment. Uncertainty/safety factors (UFs) are used in conjunction
with the POD to take into account uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. Safety is assessed for acute and chronic dietary
risks by comparing aggregate food and water exposure to the pesticide
to the acute population adjusted dose (aPAD) and chronic population
adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the
POD by all applicable UFs. Aggregate short-term, intermediate-term, and
chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the level of concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for MPOACs used for human
health risk assessment is shown in Table 1 of this unit.

    Table 1.--Summary of Toxicological Doses and Endpoints for MPOACs for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)                            Acute toxicity was not identified.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 25 mg/kg/day     Chronic RfD = 0.25 mg/   LOAEL = 50 mg/kg/day
                                       UFA = 10x..............   kg/day                   based on stomach
                                       UFH = 10x..............  cPAD = 0.25 mg/kg/day..   inflammation and
                                       Food quality protection                            mortality associated
                                        act (FQPA) SF = 1x.                               with the forestomach
                                                                                inflammation
----------------------------------------------------------------------------------------------------------------
Incidental oral (short-term and        NOAEL= 25 mg/kg/day      Residential LOC for MOE  LOAEL = 50 mg/kg/day
 intermediate-term)                     UFA = 10x.............   = 100                    based on stomach
                                       UFH = 10x..............                            inflammation and
                                       FQPA SF = 1x...........                            mortality associated
                                                                                with the forestomach
                                                                                inflammation.
----------------------------------------------------------------------------------------------------------------
Dermal and inhalation (all durations)  Quantitative assessment not required: Cluster is corrosive irritating and
                                           exposure will be self limiting; expected low-dermal and inhalation
                                          absorptions; product is used in low percentages in household products
                                                                  (i.e., low exposure).
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)         Classification: No animal toxicity data available for an assessment.
                                            Based on SAR analysis, MPOACs is not expected to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
 POD = A data point or an estimated point that is derived from observed dose-response data and used to mark the
  beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.
  NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty
  factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity
  among members of the human population (intraspecies). PAD = population adjusted dose (a=acute, c=chronic).
  FQPA SF = FQPA Safety Factor. RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A =
  not applicable.

C. Exposure Assessment

     Sufficient data were provided on the chemical identity of the
MPOACs; however, limited data are available on the metabolism and
environmental degradation of these compounds. The Agency relied
collectively on information provided on the representative chemical
structures, the generic cluster structures, the submitted
physicochemical data, structure-activity relationship information, as
well as

information on other surfactants and chemicals of similar size and
functionality to determine the residues of concern for these inert
ingredients. The residues of concern for risk assessment purposes are
the parent compounds only.
    The registrant selected CAS Reg. No. 70750-47-9, as the test
compound because the coco alkyl encompasses the broad range of
C8-C18 alkyl chain included in the descriptor.
The Agency concluded that the cluster grouping was appropriate.
Further, the Agency also concluded that it is unlikely that any
potential environmental degradates that would be found in food and
water will be more toxic than the parent compound. Residue estimates
used in the dietary risk assessment were chosen to represent an upper
bound on the combined residues of parent and any potential metabolite
or degradate of concern.
    Quantitative dermal or inhalation risk assessments were not be
performed for residential exposures because the MPOACs are highly
corrosive irritating, and therefore, exposure will be self-limiting and
will be regulated based on labeling of the formulations. There is not a
significant concern for dermal or inhalation exposures due to expected
low dermal and inhalation absorptions and the fact that the product is
used in low percentages in household products (i.e., low exposure). An
aggregate assessment need only be conducted for food, water, and
incidental oral exposures.
    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to MPOACs, EPA considered exposure under the petitioned-for
exemptions from the requirement of a tolerance. EPA assessed dietary
exposures from MPOACs in food as follows:
    i. Acute exposure. No adverse effects attributable to a single
exposure of MPOACs was seen in the toxicity databases. Therefore, acute
dietary risk assessments for MPOACs is not necessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used food consumption information from the United
States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, no residue data were submitted for MPOACs. In the
absence of specific residue data, EPA has developed an approach which
uses surrogate information to derive upper bound exposure estimates for
the subject inert ingredient. Upper bound exposure estimates are based
on the highest tolerance for a given commodity from a list of high-use
insecticides, herbicides, and fungicides. A complete description of the
general approach taken to assess inert ingredient risks in the absence
of residue data is contained in the memorandum entitled Alkyl Amines
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.
(D361707, S. Piper, 2/25/09) and can be found at http://
www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
    In the dietary exposure assessment, the Agency assumed that the
residue level of the inert ingredient would be no higher than the
highest tolerance for a given commodity. Implicit in this assumption is
that there would be similar rates of degradation (if any) between the
active and inert ingredient and that the concentration of inert
ingredient in the scenarios leading to these highest of tolerances
would be no higher than the concentration of the active ingredient.
    The Agency believes the assumptions used to estimate dietary
exposures lead to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. First, assuming that the
level of residue for an inert ingredient is equal to the level of
residue for the active ingredient will overstate exposure. The
concentrations of active ingredient in agricultural products is
generally at least 50% of the product and often can be much higher.
Further, pesticide products rarely have a single inert ingredient;
rather there is generally a combination of different inert ingredients
used which additionally reduces the concentration of any single inert
ingredient in the pesticide product in relation to that of the active
ingredient. In the case of MPOACs, EPA made a specific adjustment to
the dietary exposure assessment to account for the use limitations of
the amount of MPOACs that may be in formulations (no more than 10% by
weight in herbicide formulations) and assumed that the MPOACs are
present at the maximum limitations rather than at equal quantities with
the active ingredient. This remains a very conservative assumption
because surfactants are generally used at levels far below this
percentage.
    Second, the conservatism of this methodology is compounded by EPA's
decision to assume that, for each commodity, the active ingredient
which will serve as a guide to the potential level of inert ingredient
residues is the active ingredient with the highest tolerance level.
This assumption overstates residue values because it would be highly
unlikely, given the high number of inert ingredients, that a single
inert ingredient or class of ingredients would be present at the level
of the active ingredient in the highest tolerance for every commodity.
Finally, a third compounding conservatism is EPA's assumption that all
foods contain the inert ingredient at the highest tolerance level. In
other words, EPA assumed 100% of all foods are treated with the inert
ingredient at the rate and manner necessary to produce the highest
residue legally possible for an active ingredient. In summary, EPA
chose a very conservative method for estimating what level of inert
residue could be on food, then used this methodology to choose the
highest possible residue that could be found on food and assumed that
all food contained this residue. No consideration was given to
potential degradation between harvest and consumption even though
monitoring data shows that tolerance level residues are typically one
to two orders of magnitude higher than actual residues in food when
distributed in commerce.
    Accordingly, although sufficient information to quantify actual
residue levels in food is not available, the compounding of these
conservative assumptions will lead to a significant exaggeration of
actual exposures. EPA does not believe that this approach
underestimates exposure in the absence of residue data.
    iii. Cancer. The Agency used a qualitative SAR database, DEREK11,
to determine if there were structural alerts suggestive of
carcinogenicity. No structural alerts for carcinogenicity were
identified. MPOACs are not expected to be carcinogenic. Therefore, a
cancer dietary exposure assessment is not necessary to assess cancer
risk.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and PCT information in the dietary
assessment for MPOACs. Tolerance level residues and 100 PCT were
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for MPOACs in drinking water. These simulation models take
into account data on the physical, chemical, and fate transport
characteristics of MPOACs. Further information regarding EPA drinking
water models used in the pesticide exposure assessment can be

found at http://www.epa.gov/oppefed1/models/water/index.htm.
    A screening level drinking water analysis, based on the Pesticide
Root Zone Model /Exposure Analysis Modeling System (PRZM/EXAMS) was
performed to calculate the estimated drinking water concentrations
(EDWCs) of MPOACs. Modeling runs on four surrogate inert ingredients
using a range of physical chemical properties that would bracket those
of MPOACs were conducted. Modeled acute drinking water values ranged
from 0.001 parts per billion (ppb) to 41 ppb. Modeled chronic drinking
water values ranged from 0.0002 ppb to 19 ppb. Further details of this
drinking water analysis can be found at http://www.regulations.gov in
the document MPOACs- JITF, (CST No. 7 Inert Ingredients). Human Health
Risk Assessment to Support Proposed Exemption from the Requirement of a
Tolerance When Used as Inert Ingredients in Pesticide Formulations,
pages 13-14 and 28-46 in docket ID number EPA-HQ-OPP-2009-0042.
    For the purpose of the screening level dietary risk assessment to
support this request for an exemption from the requirement of a
tolerance for MPOACs, a conservative drinking water concentration value
of 100 ppb based on screening level modeling was used to assess the
contribution to drinking water for chronic dietary risk assessments for
the parent compounds and for the metabolites of concern. These values
were directly entered into the dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). MPOACs may be used in
inert ingredients in pesticide products that are registered for
specific uses that may result in both indoor and outdoor residential
exposures. A screening level residential exposure and risk assessment
was completed for products containing MPOACs as inert ingredients. In
this assessment, representative scenarios, based on end-use product
application methods and labeled application rates, were selected. The
MPOACs may be used as inert ingredients in pesticide formulations that
are used in and around the home. Additionally, uses are possible in
household cleaning products and in personal care products. The Agency
has not selected endpoints for dermal or inhalation risk assessmenst;
therefore, only exposure scenarios which will result in oral exposures
have been assessed for the MPOACs. The Agency conducted an assessment
to represent worst-case residential exposure by assessing
postapplication exposures and risks from MPOACs in pesticide
formulations (outdoor scenarios) and MPOACs in disinfectant-type uses
(indoor scenarios). Further details of this residential exposure and
risk analysis can be found at http://www.regulations.gov in the
memorandum 9entitled JITF Inert Ingredients. Residential and
Occupational Exposure Assessment Algorithms and Assumptions Appendix
for the Human Health Risk Assessments to Support Proposed Exemption
from the Requirement of a Tolerance When Used as Inert Ingredients in
Pesticide Formulations; (D364751, 5/7/09, Lloyd/LaMay in docket ID
number EPA-HQ-OPP-2008-0710.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity''.
    EPA has not found MPOACs to share a common mechanism of toxicity
with any other substances, and the MPOACs do not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that the MPOACs do not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's website at http://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional SF when reliable data available to EPA
support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The toxicity data available
on the MPOACs consists of acute toxicity studies, mutagenicity studies,
and an OPPTS Harmonized Guideline 870.3650 combined repeated dose
toxicity study with the reproduction developmental toxicity screening
test.
    There was no evidence of increased sensitivity in young animals
because no developmental or reproductive toxicity occurred in the
lowest dose group (doses of 25 mg/kg/day) in the reproductive
developmental toxicity screening test. Additionally, no developmental
or reproductive toxicity was noted in the mid-dose group (doses of 50
mg/kg/day); however, since there were only five surviving female
animals in this group, which is considered an insufficient number of
animals, the study LOAEL was set at the mid-dose level. The mortality
in rats that occurred in the study was associated with forestomach
inflammation. Given the extremely corrosive nature of the test
material, the Agency believes that the high mortality rate is secondary
to the forestomach lesions seen in the rats. Further, the Agency notes
that the severity of the effects may be related to the unique anatomy
of the rats. Humans do not have a forestomach which serves as a storage
reservoir in rodents; therefore effects seen in the rat forestomach are
likely to be significantly more severe than what would be expected from
the compound in the glandular stomachs in humans, and therefore, have
less relevance to humans.
    There was no evidence of neurotoxicity in the OPPTS Harmonized
Guideline 870.3650 study; functional-observational battery and motor-
activity data were similar in all the treatment groups.
    There are no residual uncertainties identified in the exposure
databases. The dietary (food and water) exposure assessment is not
likely to underestimate exposure to any subpopulation, including those
comprised of infants and children.
    3. Conclusion. EPA has determined that reliable data show that the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for MPOACs is considered adequate for
assessing the risks to infants and children (the available studies are
described in Unit IV.D.2).
    ii. No quantitative or qualitative increased susceptibility was
demonstrated in the offspring in the OPPTS Harmonized Guideline
870.3650

combined repeated dose toxicity study with the reproduction
developmental toxicity screening test in rats following in utero and
post-natal exposure.
    iii. Although mortality occurred in the OPPTS Harmonized Guideline
870.3650 study that was associated with forestomach inflammation, the
Agency believes that, given the extremely corrosive nature of the test
material, the high mortality rate is secondary to the forestomach
lesions seen in the rats. Further, the Agency notes that the severity
of the effects may be related to the unique anatomy of the rats. Humans
do not have a forestomach which serves as a storage reservoir in
rodents; therefore effects seen in the rat forestomach are likely to be
significantly more severe than what would be expected from the compound
in the glandular stomachs in humans and therefore, have less relevance
to humans.
    iv. There was no evidence of neurotoxicity in the OPPTS Harmonized
Guideline 870.3650 study. Functional-observational battery and motor-
activity data were similar in all the treatment groups. Thus, no
additional neurotoxicity data are required.
    v. While there is no chronic toxicity study, the Agency has
concluded that since endpoint risk assessment is based on the
forestomach lesions in rats, a very conservative hazard endpoint,
coupled with the highly conservative exposure assessment and an absence
of evidence of increased sensitivity, or neurotoxicity, the use of the
standard 100X inter-species and intra-species UF are adequate to
protect infants and children, and no additional UF is needed for
extrapolating from subchronic to chronic exposure.
    vi. There are no residual uncertainties identified in the exposure
databases. The food and drinking water assessment is not likely to
underestimate exposure to any subpopulation, including those comprised
of infants and children. The food exposure assessments are considered
to be highly conservative as they are based on the use of the highest
tolerance level from the surrogate pesticides for every food and 100
PCT is assumed for all crops. EPA also made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to MPOACs in drinking water. EPA used similarly conservative
assumptions to assess post-application exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by MPOACs.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. There was no hazard attributable to a single
exposure seen in the toxicity database for MPOACs. Therefore, the
MPOACs are not expected to pose an acute risk.
    2. Chronic risk. A chronic aggregate risk assessment takes into
account exposure estimates from chronic dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for chronic exposure, the chronic dietary exposure from food and water
to MPOACs is 16% of the cPAD for the U.S. population and 51% of the
cPAD for children 1-2 yrs old, the most highly exposed population
subgroup.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
     MPOACs are used as an inert ingredients in pesticide products that
are currently registered for uses that could result in short-term
residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to MPOACs. Using the exposure
assumptions described in this unit, EPA has concluded the combined
short-term aggregated food, water, and residential exposures result in
an aggregate MOE of 190 for children. Children's residential exposure
includes hand-to-mouth exposures. As the LOC is for MOEs that are lower
than 100, this MOE is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    MPOACs are currently registered for uses that could result in
intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to MPOACs. Using the
exposure assumptions described in this unit, EPA has concluded the
combined intermediate-term aggregated food, water, and residential
exposures result in an aggregate MOE of 190 for children. Children's
residential exposure includes hand-to-mouth exposures. As the LOC is
for MOEs that are lower than 100, this MOE is not of concern.
     5. Aggregate cancer risk for U.S. population. The Agency has not
identified any concerns for carcinogenicity relating to MPOACs.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to residues of MPOACs.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    The Agency is not aware of any country requiring a tolerance for
MPOACs nor have any CODEX Maximum Residue Levels been established for
any food crops at this time.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance is
established for residues methyl poly(oxyethylene)C8-
C18 alkylammonium chlorides where the poly(oxyethylene)
content is n=2-15 and where C8-C18 alkyl is
linear and may be saturated or unsaturated (MPOACs) for pre-harvest
uses at a maximum of 10% by weight in herbicide formulations and 5% by
weight in all other formulations.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735,

October 4, 1993). Because this final rule has been exempted from review
under Executive Order 12866, this final rule is not subject to
Executive Order 13211, entitled Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VIII. 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 to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: July 21, 2009.
G. Jeffrey Herndon,
Acting Director, Registration 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), 346a and 371.
0
2. In Sec. 180.920, the table is amended by adding alphabetically the
following inert ingredients to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
       Inert Ingredients               Limits               Uses
-----------------------------------------------------------------------
                              * * * * * * *
Methyl poly(oxyethylene)C8-C18   Concentration in    Surfactants,
 alkylammonium chlorides where    formulated end      related
 the poly(oxyethylene) content    use products not    adjuvants of
 is n=2-15 and where C8-C18       to exceed 10% by    surfactants
 alkyl is linear and may be       weight in
 saturated or unsaturated (CAS    herbicide
 Reg. Nos. 3010-24-0, 18448-65-   products and 5%
 2, 70750-47-9, 22340-01-8,       by weight in all
 67784-77-4, 64755-05-1, 61791-   other pesticide
 10-4, 28724-32-5, 28880-55-9,    products.
 68187-69-9, 68607-27-2, 60687-
 90-3..
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. E9-18348 Filed 8-4-09; 8:45 am]

BILLING CODE 6560-50-S