[Federal Register Volume 78, Number 26 (Thursday, February 7, 2013)]
[Notices]
[Pages 9073-9076]
[FR Doc No: 2013-02745]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68813; File No. SR-EDGA-2013-06]

Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
EDGA Rule 11.13 To Extend the Operation of a Pilot Pursuant to Rule
11.13 Until September 30, 2013

February 1, 2013.
    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 January 31, 2013, EDGA Exchange, Inc. (the ``Exchange'' or
``EDGA'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II 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\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend EDGA Rule 11.13 to extend the
operation of a pilot pursuant to Rule 11.13 (the ``Pilot'') until
September 30, 2013. The Exchange also proposes to adopt new paragraph
(i) to Rule 11.13 in connection with the upcoming operation of the Plan
to Address Extraordinary Market Volatility Pursuant to Rule 608 of
Regulation NMS under the Act (the ``Limit Up-Limit Down Plan'' or the
``Plan'').\3\ All of the changes described herein are applicable to
EDGA Members. The text of the proposed rule change is available on the
Exchange's Internet Web site at www.directedge.com, at the Exchange's

principal office, and at the Public Reference Room of the Commission.
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    \3\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012).
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the 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 these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in sections A, B and C below, of the
most significant aspects of such statements.

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

1. Purpose
    The purpose of this filing is to extend the effectiveness of the
Exchange's current rule applicable to Clearly Erroneous Executions and
to adopt new paragraph (i) to Rule 11.13 in connection with upcoming
operation of the Limit Up-Limit Down Plan.
Background
    Portions of Rule 11.13, explained in further detail below, are
currently operating as the Pilot and are set to expire on February 4,
2013.\4\ The Exchange proposes to extend the Pilot to September 30,
2013.
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    \4\ See Securities Exchange Act Release No. 67500 (July 25,
2012), 77 FR 45398 (July 31, 2012) (SR-EDGA-2012-30).
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    On September 10, 2010, the Commission approved, on a pilot basis,
changes to EDGA Rule 11.13 to provide for uniform treatment: (1) Of
clearly erroneous execution reviews in multi-stock events involving
twenty or more securities; and (2) in the event transactions occur that
result in the issuance of an individual stock trading pause by the
primary market and subsequent transactions that occur before the
trading pause is in effect on the Exchange.\5\ The Exchange also
adopted additional changes to Rule 11.13 that reduced the ability of
the Exchange to deviate from the objective standards set forth in Rule
11.13.\6\ The Exchange believes the benefits to market participants
from the more objective clearly erroneous executions rule should
continue on a pilot basis through September 30, 2013, which is the date
that the Exchange anticipates that the phased implementation of the
Limit Up-Limit Down Plan will be complete. As explained in further
detail below, although the Limit Up-Limit Down Plan is intended to
prevent executions that would need to be nullified as clearly
erroneous, the Exchange believes that certain protections should be
maintained while the industry gains initial experience operating with
the Limit Up-Limit Down Plan, including the provisions of Rule 11.13
that currently operate as a pilot.
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    \5\ See Securities Exchange Act Release No. 62886 (September 10,
2010), 75 FR 56613 (September 16, 2010) (SR-EDGA-2010-03).
    \6\ Id.
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Proposed Limit Up-Limit Down Provision to Rule 11.13
    The Exchange proposes to adopt new paragraph (i) to Rule 11.13, to
provide that the existing provisions of Rule 11.13 will continue to
apply to all Exchange transactions, including transactions in
securities subject to the Plan, other than as set forth in proposed
paragraph (i). Accordingly, other than as proposed below, the Exchange
proposes to maintain and continue to apply the Clearly Erroneous
Execution standards in the same way that it does today. Notably, this
means that the Exchange might nullify transactions that occur within
the price bands disseminated pursuant to the Limit Up-Limit Down Plan
to the extent such transactions qualify as clearly erroneous under
existing criteria. As an example, assume that a Tier 1 security
pursuant to the Plan has a reference price pursuant to both the Plan
and Rule 11.13 of $100.00. The lower pricing band under the Plan would
be $95.00 and the upper pricing band under the Plan would be $105.00.
An execution could occur on the Exchange in this security at $96.00, as
this is within the Plan's pricing bands. However, if subjected to
review as potentially clearly erroneous, the Exchange would nullify an
execution at $96.00 as clearly erroneous because it exceeds the 3%
threshold that is in place pursuant to Rule 11.13(c)(1) for securities
priced above $50.00 (i.e., with a reference price of $100.00, any
transactions at or below $97.00 or above $103.00 could be nullified as
clearly erroneous). Accordingly, this proposal maintains the status quo
with respect to reviews of Clearly Erroneous Executions and the
application of objective numerical guidelines by the Exchange. The
proposal does not increase the discretion afforded to the Exchange in
connection with reviews of Clearly Erroneous Executions.
    The Limit Up-Limit Down Plan is designed to prevent executions from
occurring outside of dynamic price bands disseminated to the public by
the single plan processor as defined in the Limit Up-Limit Down
Plan.\7\ The possibility remains that the Exchange could experience a
technology or systems problem with respect to the implementation of the
price bands disseminated pursuant to the Plan. To address such
possibilities, the Exchange proposes to adopt language to make clear
that if an Exchange technology or systems issue results in any
transaction occurring outside of the price bands disseminated pursuant
to the Plan, an Officer of the Exchange or senior level employee
designee, acting on his or her own motion or at the request of a third
party, shall review and declare any such trades null and void. Absent
extraordinary circumstances, any such action of the Officer of the
Exchange or other senior level employee designee shall be taken in a
timely fashion, generally within thirty (30) minutes of the detection
of the erroneous transaction. When extraordinary circumstances exist,
any such action of the Officer of the Exchange or other senior level
employee designee must be taken by no later than the start of Regular
Trading Hours \8\ on the trading day following the date on which the
execution(s) under review occurred. Although the Exchange will act as
promptly as possible and the proposed objective standard (i.e., whether
an execution occurred outside the band) should make it feasible to
quickly make a determination, there may be circumstances in which
additional time may be needed for verification of facts or coordination
with outside parties, including the single plan processor responsible
for disseminating the price bands and other market centers.
Accordingly, the Exchange believes it necessary to maintain some
flexibility to make a determination outside of the thirty (30) minute
guideline. In addition, the Exchange proposes that a transaction that
is nullified pursuant to new paragraph (i) would be appealable in
accordance with the provisions of Rule 11.13(e)(2). In addition, the
Exchange proposes to make clear that in the event that a single plan
processor experiences a technology or systems problem that prevents the
dissemination of price bands, the Exchange would make the determination
of whether to nullify transactions based on Rule 11.13(a)-(h).
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    \7\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012).
    \8\ Regular Trading Hours commence at 9:30 a.m. Eastern Time.
See Exchange Rule 1.5(y).
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    The Exchange believes that cancelling trades that occur outside of
the price bands disseminated pursuant to the Plan is consistent with
the purpose and

intent of the Plan, as such transactions are not intended to occur in
the first place. If transactions do occur outside of the price bands
and no exception applies--which necessarily would be caused by a
technology or systems issue--then the Exchange believes the appropriate
result is to nullify such transactions.
2. Statutory Basis
    The statutory basis for the proposed rule change is Section 6(b)(5)
of the Act,\9\ which requires the rules of an exchange to promote just
and equitable principles of trade, to remove impediments to and perfect
the mechanism of a free and open market and a national market system
and, in general, to protect investors and the public interest. The
Exchange believes that the proposed rule meets these requirements in
that it promotes transparency and uniformity across markets concerning
review of transactions as clearly erroneous. More specifically, the
Exchange believes that the extension of the Pilot would help assure
that the determination of whether a clearly erroneous trade has
occurred will be based on clear and objective criteria, and that the
resolution of the incident will occur promptly through a transparent
process. The proposed rule change would also help assure consistent
results in handling erroneous trades across the U.S. markets, thus
furthering fair and orderly markets, the protection of investors and
the public interest. Although the Limit Up-Limit Down Plan will be
operational during the same time period as the proposed extended Pilot,
the Exchange believes that maintaining the Pilot for at least through
the phased implementation of the Plan is operational will help to
protect against unanticipated consequences. To that end, the extension
will allow the Exchange to determine whether Rule 11.13 is necessary
once the Plan is operational and, if so, whether improvements can be
made. Further, the Exchange believes it consistent with the protection
of investors and the public interest to adopt objective criteria to
nullify transactions that occur outside of the Plan's price bands when
such transactions should not have been executed but were due to a
systems or technology issue.

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    \9\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Financial Industry
Regulatory Authority (``FINRA'') and other national securities
exchanges are also filing similar proposals. Thus the Exchange believes
that the proposal will help to ensure consistent rules across market
centers.

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

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

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \10\ and Rule 19b-
4(f)(6)(iii) thereunder.\11\
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6)(iii). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
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    A proposed rule change filed under Rule 19b-4(f)(6) \12\ normally
does not become operative for 30 days after the date of filing.
However, pursuant to Rule 19b-4(f)(6)(iii) \13\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing.
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    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ 17 CFR 240.19b-4(f)(6)(iii).
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    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest, as
it will allow the pilot program to continue uninterrupted, thereby
avoiding the investor confusion that could result from a temporary
interruption in the pilot program. For this reason, the Commission
designates the proposed rule change to be operative upon filing.\14\
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    \14\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission 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.

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-EDGA-2013-06 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-EDGA-2013-06. 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 the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; 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-EDGA-2013-06 and should be
submitted on or before February 28, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
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    \15\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-02745 Filed 2-6-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: July 27, 2007 (Volume 72, Number 144)]
[Rules and Regulations]
[Page 41224-41230]
[DOCID:fr27jy07-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2004-0257; FRL-8127-9]

Chlorthalonil; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for the combined
residues of chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile, in or on pea, edible podded. The Snowpea
Commission of Guatemala requested this tolerance under the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA).

DATES: This regulation is effective July 27, 2007. Objections and
requests for hearings must be received on or before September 25, 2007,
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-2004-0257. All documents in the
docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Tony Kish, 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:
     Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket 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 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines

referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2004-0257 in the
subject line on the first page of your submission. All requests must be
in writing, and must be

mailed or delivered to the Hearing Clerk on or before September 25,
2007.
    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 your copies, identified by docket ID
number EPA-HQ-OPP-2004-0257, 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 Drive, Arlington, VA. Deliveries are only
accepted during the Docket'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 and Statutory Findings

    In the Federal Register of August 20, 2004 (69 FR 51672) (FRL-7674-
2), 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
3E6795) by the Snowpea Commission of Guatemala, Guatemala City,
Guatemala; GB Bioscience\TM\ Corporation of Greensboro, NC serves as
the agent for the Snowpea Commission of Guatemala. The petition
requested that 40 CFR 180.275 be amended by establishing a tolerance
for combined residues of the fungicide chlorothalonil, and its
metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile, in or on pea,
edible podded (to include snowpea, and sugar snap pea) at 5 parts per
million (ppm). That notice included a summary of the petition prepared
by GB BioscienceTM Corporation, the registrant. Comments
were received on the notice of filing. EPA's response to these comments
is discussed in Unit IV.C.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of 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. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see
     http://www.epa.gov/oppfead1/trac/science     http://www.epa.gov/pesticides/factsheets/riskassess.htm.

s/riskassess.htm.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section
408(b)(2) of FFDCA, for a tolerance for the combined residues of
chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile on pea, edible podded at 5 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by chlorothalonil and its metabolite, 4-
hydroxy-2,5,6-trichloroisophthalonitrile, as well as the no observed
adverse effect level (NOAEL) and the lowest observed adverse effect
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov.
 The referenced document is available in Docket ID

EPA-HQ-OPP-2004-0257.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at:
     http://www.epa.gov/pesticides/health/human.htm     http://www.epa.gov/pesticides/facsheets/riskassess.htm.

s/facsheets/riskassess.htm.

    The chronic dietary endpoint used in this rule 0.003 milligrams/
kilogram/day (mg/kg/day) is based on new toxicity data the Agency
received, and is approximately 6.6 fold less than the endpoint of 0.02
mg/kg/day used in the chlorothalonil risk assessment for the April 1999
RED. The Agency has received and is reviewing additional information
which could change this lower chronic dietary endpoint. A summary of
the toxicological endpoints for chlorothalonil used for human risk
assessment is shown in Table 1:

             Table 1.--Summary of Toxicological Dose and Endpoints for Use in Human Risk Assessment
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                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure/Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
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Chronic Dietary (All populations)      NOAEL= < 0.9 mg/kg/day    Special FQPA SF = 1X     Rat Chronic
                                       UF = 300...............  cPAD = chronic RfD/      LOAEL = 0.9 mg/kg/day
                                       Chronic RfD = 0.003 mg/   Special FQPA SF =        based on an increased
                                        kg/day.                  0.003 mg/kg/day.         incidence and severity
                                                                                of epithelial
                                                                                hyperplasia,
                                                                                hyperkeratosis and
                                                                                ulceration of the non-
                                                                                glandular region of
                                                                                the stomach in females
----------------------------------------------------------------------------------------------------------------
Short-Term Oral (1 to 7 days)          Oral study               LOC for Margin of        Rat Two-Generation
(Residential)........................  NOAEL= < 30.8 mg/kg/day.   Exposure (MOE) = 1,000  LOAEL = 30.8 mg/kg/day
                                                                (Residential)..........   based on thickening
                                                                                and/or roughening of
                                                                                the forestomach with
                                                                                depressions in the
                                                                                epithelial aspect, and
                                                                                hyperplasia and
                                                                                hyperkeratosis of the
                                                                                non-glandular
                                                                                epithelium of the
                                                                                stomach
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 30 days)   Inhalation (or oral)     LOC for MOE = 1,000      Rat Reproduction Study
(Residential)........................   study                   (Residential)..........  LOAEL = 30.8 mg/kg/day
                                       NOAEL= 30.8 mg/kg/day                              based on thickening
                                        (inhalation absorption                            and/or roughening of
                                        rate = 100%.                                      the forestomach with
                                                                                depressions in the
                                                                                epithelial aspect, and
                                                                                hyperplasia and
                                                                                hyperkeratosis of the
                                                                                non-glandular
                                                                                epithelium of the
                                                                                stomach
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1-6      Oral study               LOC for MOE = 1,000      Rat Reproduction Study
 months)                               NOAEL = 30.8 mg/kg/day   (Residential)..........  LOAEL = 30.8 mg/kg/day
(Residential)........................   inhalation absorption                             based on thickening
                                        rate = 100%.                                      and/or roughening of
                                                                                the forestomach with
                                                                                depressions in the
                                                                                epithelial aspect, and
                                                                                hyperplasia and
                                                                                hyperkeratosis of the
                                                                                non-glandular
                                                                                epithelium of the
                                                                                stomach
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      NA                       NA                       Classification:
                                                                                ``Likely'' to be a
                                                                                human carcinogen by
                                                                                all routes of
                                                                                exposure. The Science
                                                                                Advisory Panel
                                                                                decision (6/30/98)
                                                                                supports the use of an
                                                                                MOE approach to
                                                                                adequately quantify
                                                                                cancer risk for
                                                                                chlorothalonil
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.275) for the combined residues of
chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile, in or on a variety of raw agricultural
commodities. Tolerances currently exist on almond; apricot; asparagus;
banana; bean, dry; bean, snap; blueberry; broccoli; Brussels sprouts;
cabbage; carrot; cauliflower; celery; cherry, sweet; cherry, tart;
cocoa bean; coffee bean, corn, sweet; cranberry; cucumber; mango;
melon; mushroom; nectarine; onion, dry bulb; onion, green; papaya;
parsnip; passionfruit; peach; peanut; pepper, nonbell; pistachio; plum;
plum, prune; potato; pumpkin; soybean; squash, summer; squash, winter;
tomato; and various animal commodities for cattle; goat; hog; horse;
milk; and sheep. There is also a time-limited tolerance on ginseng and
tolerances with regional registration on filbert and mint, hay. Risk
assessments were conducted by EPA to assess dietary exposures from
chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1 day or single exposure.
    No such effects were identified in the toxicological studies for
chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile; therefore, a quantitative acute dietary
exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the Dietary Exposure Evaluation Model software
with the Food Commodity Intake Database (DEEM-FCID\TM\), which
incorporates food consumption data as reported by respondents in the
USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII), and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: A Tier 3, chronic dietary-exposure assessment was refined
by making use of anticipated residues derived from monitoring data from
the Pesticide Data Program (PDP) and Food and Drug Administration
surveillance monitoring, percent crop treated estimates, and the
processing factors used in the Reregistration Eligibility Decision for
Chlorothalonil (Document number EPA 738-R-99-004, April 1999). Drinking
water was incorporated directly into the dietary assessment using the
estimated maximum allowable Estimated Drinking Water Concentration
(EDWC) of 42 ppb.
    iii. Cancer. EPA has determined that a non-linear approach to
cancer risk assessment is appropriate. Therefore the chronic RfD is
considered to be protective for this effect.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide chemicals that have been
measured in food. If EPA

relies on such information, EPA must pursuant to section 408(f)(1)
require that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. Following the initial
data submission, EPA is authorized to require similar data on a time
frame it deems appropriate. For the present action, EPA will issue such
Data Call-Ins (DCIs) for information relating to anticipated residues
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Such DCIs will be required to be submitted no
later than 5 years from the date of issuance of this tolerance. Mean
anticipated residues were estimated from PDP monitoring data for
apricot; asparagus; banana and plantain; bean, green; bean/pea, dry;
broccoli, Brussels sprouts; carrot; cauliflower; celery; cherry; corn,
sweet; cucumber; melon; milk; mushroom; nectarine, parsnip; peach;
pepper, non-bell; potato; plum; pumpkin; prune; squash; and tomato.
Mean anticipated residues were estimated from FDA monitoring data for
blueberry; cabbage; cranberry; mango; onion, dry bulb; papaya; peanut;
and soybean. Empirical processing factors were used for bean, green,
cooked, canned, or frozen; cabbage; carrot, processed or cooked;
cherry, processed; cocoa; coffee; cucumber, pickled; peach, cooked and
canned; peanut, oil; pea, edible podded, cooked and processed; prunes;
pumpkin; soybean, oil; squash, winter, cooked; and tomato, processed.
Default processing factors were used for all other food commodities.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if the Agency can make the following findings: Condition 1,
that the data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit
data on PCT.
    The Agency used PCT information as follows:
    Almond, 100%; apricot, 10%; asparagus; 15%; banana and plantain,
100%; bean, green, 20%; bean/pea, dry, 1%; blueberry, 15%; broccoli,
10%; Brussels sprouts, 68%; cabbage, 40%; carrot, 45%; cattle, 100%;
cauliflower, 10%; celery, 65%; cherry, 35%; cocoa, 100%; coffee, 100%;
corn, sweet, 100%; cranberry, 100%; cucumber, 45%; filbert, 100%;
ginseng, 100%; goat, 100%; hog, 100%; horse, 100%; mango, 100%; melon,
cantaloupe, 60%; melon, honeydew, 18%; melon, watermelon and other,
84%; milk, 100%; mushroom, 100%; nectarine, 100%; onion, dry bulb, 50%;
onion, green, 100%; papaya, 100%; parsnip, 100%; passionfruit, 100%;
peach, 15%; peanut, 65%; pea, edible podded, 100%; pepper, non-bell,
100%; pistachio, 100%; potato, 60%; plum and prune, 5%; pumpkin, 40%;
sheep, 100%; soybean, 100%; squash, 35%; and tomato, 45%.
    The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. The Agency is reasonably certain that the percentage of
the food treated is not likely to be an underestimation. As to
Conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which chlorothalonil
may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for chlorothalonil and its
metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
http://www.epa.gov/oppefed1/models/water/index.htm.

    The modeling showed that chronic drinking water levels of
chlorothalonil from the most intensive use (i.e., sodfarms) would, in
combination with other exposures, raise a risk of concern. EPA believes
that this modeling estimate significantly overstates exposure not only
because its surface water model is generally conservative, but due to
several factors unique to this risk assessment. First, the EDWC for
chlorothalonil and its major metabolite was estimated using the
mobility factor for chlorothalonil's major metabolite, which is
considered more mobile than the parent. EPA does not have a method to
calculate model input values for mobility of combined toxic residues;
therefore, the most conservative value was used for the model. Second,
EPA assumed use of maximum sodfarm application rates, application
intervals, and agronomic practices which are not always employed.
Third, EPA assumed that 100% of a watershed consists of sodfarm turf,
compared with recent preliminary data showing that 50% or less is a
more realistic number. Fourth, EPA assumed that all sodfarms in any
given watershed area would be treated with chlorothalonil in the same
season, and at the same time, which is unlikely to occur. Despite EPA's
conclusion that the predicted EDWC overstates exposure, EPA conducted a
sensitivity analysis to determine what sodfarm usage rate would lower
predicted drinking water levels by a sufficient amount to eliminate any
risk concerns. EPA's analysis showed that the maximum allowable EDWC to
be 42 ppb, and that reducing the maximum application rate for sodfarms
from 26 lbs of active ingredient/acre/year to 13 lbs active ingredient/
acre/year would result in acceptable EDWC of less than 42 ppb. This
reduction in the maximum sodfarm application rate is being incorporated
on all affected chlorothalonil product labels.
    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).
    Chlorothalonil is currently registered for use on the following
residential non-dietary sites: Golf courses and additive for paints.
The risk assessment was

conducted using the following residential exposure assumptions: There
is potential for residential exposure from treated golf courses and
from using treated paint. All other turf uses involving chlorothalonil
exposure to toddlers and children have been canceled. EPA has
determined that there is no hazard via the dermal route; therefore,
quantification of a dermal risk assessment is not required. Inhalation
post-application exposures for golf courses were not assessed since
inhalation exposures are thought to be negligible in outdoor post-
application scenarios. Consequently, only inhalation and incidental
oral exposures from the use of treated paint were assessed. The short-
and intermediate-term inhalation and incidental oral MOEs are greater
than the target MOE of 1000 and, therefore, do not exceed EPA's level
of concern (LOC).
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to chlorothalonil and any
other substances and chlorothalonil does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that chlorothalonil
has a common mechanism of toxicity with other substances. In the
chlorothalonil RED, chlorothalonil was grouped in the polychlorinated
fungicide class of pesticides. Other members of this class include
hexachlorobenzene (HCB), pentachlorophenol (PCP), and
pentachloronitrobenzene (PCNB). This is considered a weak
classification, with the only point of commonality is that they are
polychlorinated compounds used as fungicides. Available data do not
support a finding for a common mechanism of toxicity for chlorothalonil
and the other pesticides in the polychlorinated fungicide class.
Chlorothalonil produces renal (kidney) tubular adenomas and carcinomas
and papillomas of the stomach in rats. Chlorothalonil also produces
gastric lesions and kidney toxicity due to perturbation of
mitochondrial respiration. The other pesticides in the class do not
have the same toxic effects and do not have the same mode of action.For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. EPA has concluded that there
is no increased susceptibility following prenatal or postnatal exposure
to chlorothalonil in rats. There is equivocal evidence of increased
susceptibility in rabbits; however, the degree of concern for prenatal
susceptibility is low. There is a well-defined NOAEL in the rabbit
developmental toxicity study protecting from these effects. In
addition, developmental effects were observed in only one of the two
developmental toxicity studies conducted in the same strain of rabbit
at the same dose levels. Therefore, based on overall weight-of-
evidence, EPA concluded that there is no increased susceptibility
following exposure to chlorothalonil or its 4-hydroxy-2,5,6-
trichloroisophthalonitrile metabolite.
    3. Conclusion. There is a complete toxicity data base for
chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile, and exposure data are complete or are
estimated based on data that reasonably accounts for potential
exposures. The acute, subchronic, developmental, reproduction and
chronic studies were sufficient to determine whether human hazard could
exist within the context of dose, duration, timing, and route-of-
exposure. The uncertainty factor used in determining the chronic
reference dose (cRfD) was 300 (10X for interspecies animal-to-human
extrapolation; 10X for intraspecies human variations; and 3X for use of
a LOAEL instead of a NOAEL). The uncertainty factor of 3X for use of
the LOAEL instead of the NOAEL is considered appropriate because an
increased incidence and severity of epithelial hyperplasia,
hyperkeratosis and ulceration of the non-glandular region of the
stomach in females were seen in few animals and were minimal in
severity and observed in one sex only. The chlorothalonil FQPA safety
factor was reduced to 3X for chronic risk assessment but retained at
10X for residential assessments. The data from the chronic toxicity
study in rats show that a 3X factor in the chronic risk assessment is
protective of infants and children despite the lack of a NOAEL in that
study. As to the residential risk assessment, there are insufficient
reliable data to conclude that a reduction of the 10X FQPA safety
factor is safe for infants and children given the lack of a NOAEL in
the study upon which the residential risk assessment is based. Other
than the lack of NOAELs in these two critical studies, other
considerations raise no concern for the safety of infants and children.
Specifically, (1) the hazard and exposure databases are complete; (2)
there are low concerns for prenatal and/or postnatal toxicity; (3)
there are no residual uncertainties with regard to prenatal and/or
postnatal toxicity; and (4) there are no neurotoxic concerns.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. No acute effects were identified in the
toxicological studies for chlorothalonil and its metabolite, 4-hydroxy-
2,5,6-trichloroisophthalonitrile; therefore, a quantitative acute
dietary exposure assessment is unnecessary. In the 1999 Chlorothalonil
Registration Elibibility Document, the acute RfD was based on the
results of a of 90-day study in rats in which gastric renal lesions
were observed beginning at 7 days of continuous dosing. These type of
lesions and in particular, the time frame at which they occurred (after
7 days of continuous high-dose administrations), do not meet the
criteria of a single-dose effect.

    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile from food will utilize 3% of the cPAD for
the U.S. population, 2% of the cPAD for all infants, and 8% of the cPAD
for children 1-2 years old. There are no residential uses for
chlorothalonil that result in chronic residential exposure to
chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile. Based on approved use pattern, chronic
residential exposure to residues of chlorothalonil are not expected. In
addition, there is potential for chronic dietary exposure to
chlorothalonil in drinking water. Analyses by the Agency indicate that
42 ppb is the maximum residue concentration (parent plus metabolite) in
drinking water which results in acceptable levels of chronic aggregrate
risk. However, as explained prior in Unit III.C.2., this 42 ppb EDWC is
considered conservative. EPA does not expect the aggregate exposure to
exceed 100% of the cPAD, as shown in Table 2:

             Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Chlorothalonil
----------------------------------------------------------------------------------------------------------------
                                                                %/cPAD/      Surface      Ground/
              Population/Subgroup                cPAD/mg/kg/   (Food plus   Water EEC/   Water EEC/    Chronic/
                                                     day         water)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                        0.003           33     N/A (Not          N/A          N/A
                                                                           Applicable)
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year old)                              0.003           99          N/A          N/A          N/A
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old                                 0.003           52          N/A          N/A          N/A
----------------------------------------------------------------------------------------------------------------
Adults 20-49 years old                                 0.003           30          N/A          N/A          N/A
----------------------------------------------------------------------------------------------------------------

    3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
    Chlorothalonil is currently registered for use that could result in
short-term and intermediate-term residential exposure and the Agency
has determined that it is appropriate to aggregate chronic food and
water and short-term and intermediate-term exposures for chlorothalonil
and its metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded that food,
water, and residential exposures aggregated result in aggregate MOEs of
8,600 for adults 20-49 years old. These aggregate MOEs do not exceed
the Agency's level of concern for aggregate exposure to food, water,
and residential uses. Dietary exposure was calculated assuming residues
in water of 42 ppb.
    5. Aggregate cancer risk for U.S. population. EPA has determined
that a non-linear approach to cancer risk assessment is appropriate and
that the chronic RfD is considered to be protective for this effect.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate residue analytical methods are available for purposes of
registration. The Pesticide Analytical Manual (PAM) Vol. II lists
Method I, a gas chromatography (GC) method with electron-capture
detection (ECD), for the enforcement of tolerances for plant
commodities.

B. International Residue Limits

    There are no conflicts between existing U.S. tolerances and MRLs
established by the CODEX Alimentarius Commission.

C. Response to Comments

    One comment dated September 4, 2004, was received from B. Sachau.
Ms. Sachau's comments regarding general exposure to pesticides
contained no scientific data or evidence to rebut the Agency's
conclusion that there is a reasonable certainty that no harm will
result from aggregate exposure to chlorothalonil, including all
anticipated dietary exposures and other exposures for which there is
reliable information. This comment, as well as her comments regarding
animal testing, has been responded to by the Agency on several
occasions. For example, January 7, 2005 (70 FR 1349) (FRL-7691-4) and
October 29, 2004 (69 FR 63083) (FRL-7681-9).

V. Conclusion

    Therefore, the tolerance is established for the combined residues
of chlorothalonil, and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile, in or on pea, edible podded (includes snow
pea and sugar snap pea) at 5 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from

Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note). Since tolerances and exemptions that are established on the
basis of a petition under section 408(d) of FFDCA, such as the
tolerance in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitledFederalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of FFDCA.
For these same reasons, the Agency has determined that this rule does
not have any ``tribal implications'' as described in Executive Order
13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: July 13, 2007.
Lois Rossi,
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. Section 180.275 is amended by alphabetically adding the following
commodity to the table in paragraph (a)(1) to read as follows:

Sec. 180.275   Chlorothalonil; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Pea, edible podded                                                     5
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E7-14567 Filed 7-26-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 76, Number 33 (Thursday, February 17, 2011)]
[Notices]
[Pages 9339-9340]
[FR Doc No: 2011-3625]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14085-000]

Village of Swanton, VT; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

    On February 4, 2011, the Village of Swanton, Vermont (Swanton)
filed an application for a preliminary permit, pursuant to section 4(f)
of the Federal

Power Act (FPA), proposing to study the feasibility of the Swanton Dam
Hydroelectric Project to be located on the Missisquoi River in the
Village of Swanton, Franklin County, Vermont. The sole purpose of a
preliminary permit, if issued, is to grant the permit holder priority
to file a license application during the permit term. A preliminary
permit does not authorize the permit holder to perform any land-
disturbing activities or otherwise enter upon lands or waters owned by
others without the owners' express permission.
    The proposed project would consist of: (1) The existing 12-foot-
high, 335-foot-long Swanton dam equipped with a 331-foot-long spillway;
(2) the existing 170-acre reservoir with a normal water surface
elevation of 108 feet NGVD; (3) an existing headgate structure equipped
with trashracks; (4) a new powerhouse containing two turbine generating
units with a total installed capacity of 825 kilowatts; (5) a new 45-
foot-wide, 45-foot-long tailrace; and (6) a new 210-foot-long, 12.47-
kilovolt transmission line. The project would produce an estimated
average annual generation of about 3,580 megawatt-hours.
    Applicant Contact: Paul Nolan, 5515 North 17th Street, Arlington,
VA 22205, phone:<PHONE_NUMBER>.
    FERC Contact: Tom Dean<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 Days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14085) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: February 10, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-3625 Filed 2-16-11; 8:45 am]
BILLING CODE 6717-01-P